Ceftrialin

Ceftrialin may be available in the countries listed below.

Ingredient matches for Ceftrialin

Ceftriaxone

Ceftriaxone is reported as an ingredient of Ceftrialin in the following countries:

• Venezuela

International Drug Name Search

Atenolol Helvepharm

Atenolol Helvepharm may be available in the countries listed below.

Ingredient matches for Atenolol Helvepharm

Atenolol

Atenolol is reported as an ingredient of Atenolol Helvepharm in the following countries:

• Switzerland

International Drug Name Search

Ibuprofen Kela

Ibuprofen Kela may be available in the countries listed below.

Ingredient matches for Ibuprofen Kela

Ibuprofen

Ibuprofen is reported as an ingredient of Ibuprofen Kela in the following countries:

• Belgium

International Drug Name Search

Ifex

In the US, Ifex (ifosfamide/mesna systemic) is a member of the drug class alkylating agents and is used to treat Cancer, Cervical Cancer and Testicular Cancer.

US matches:

• Ifex


• Ifex Solution


• Ifex/Mesnex Kit

Ingredient matches for Ifex

Ifosfamide

Ifosfamide is reported as an ingredient of Ifex in the following countries:

• Canada


• United States

International Drug Name Search

Estazolam Changzhou Siyao Pharm

Estazolam Changzhou Siyao Pharm may be available in the countries listed below.

Ingredient matches for Estazolam Changzhou Siyao Pharm

Estazolam

Estazolam is reported as an ingredient of Estazolam Changzhou Siyao Pharm in the following countries:

• China

International Drug Name Search

Bicalutamid-Mepha

Bicalutamid-Mepha may be available in the countries listed below.

Ingredient matches for Bicalutamid-Mepha

Bicalutamide

Bicalutamide is reported as an ingredient of Bicalutamid-Mepha in the following countries:

• Switzerland

International Drug Name Search

Muni

Muni may be available in the countries listed below.

Ingredient matches for Muni

Hydrocortisone

Hydrocortisone is reported as an ingredient of Muni in the following countries:

• Germany

International Drug Name Search

Fortedol

Fortedol may be available in the countries listed below.

Ingredient matches for Fortedol

Diclofenac

Diclofenac potassium salt (a derivative of Diclofenac) is reported as an ingredient of Fortedol in the following countries:

• Hungary

International Drug Name Search

Flo cillin

In some countries, this medicine may only be approved for veterinary use.

Ingredient matches for Flo cillin

Benzylpenicillin

Benzylpenicillin benzathine and procaine (a derivative of Benzylpenicillin) is reported as an ingredient of Flo cillin in the following countries:

• United States

International Drug Name Search

Fentanyl Oralet

Ingredient matches for Fentanyl Oralet

Fentanyl

Fentanyl citrate (a derivative of Fentanyl) is reported as an ingredient of Fentanyl Oralet in the following countries:

• United States

International Drug Name Search

Laktulose NM Pharma

Laktulose NM Pharma may be available in the countries listed below.

Ingredient matches for Laktulose NM Pharma

Lactulose

Lactulose is reported as an ingredient of Laktulose NM Pharma in the following countries:

• Iceland

International Drug Name Search

Medifungol

Medifungol may be available in the countries listed below.

Ingredient matches for Medifungol

Clotrimazole

Clotrimazole is reported as an ingredient of Medifungol in the following countries:

• Argentina

International Drug Name Search

Migränin Phenazon

Migränin Phenazon may be available in the countries listed below.

Ingredient matches for Migränin Phenazon

Phenazone

Phenazone is reported as an ingredient of Migränin Phenazon in the following countries:

• Germany

International Drug Name Search

Trace

Trace may be available in the countries listed below.

Ingredient matches for Trace

Tramadol

Tramadol hydrochloride (a derivative of Tramadol) is reported as an ingredient of Trace in the following countries:

• Germany

International Drug Name Search

Lidocainhydrochlorid

Lidocainhydrochlorid may be available in the countries listed below.

In some countries, this medicine may only be approved for veterinary use.

Ingredient matches for Lidocainhydrochlorid

Lidocaine

Lidocaine hydrochloride (a derivative of Lidocaine) is reported as an ingredient of Lidocainhydrochlorid in the following countries:

• Germany

International Drug Name Search

Metharmone F

Metharmone F may be available in the countries listed below.

Ingredient matches for Metharmone F

Androstenedione

Androstenedione is reported as an ingredient of Metharmone F in the following countries:

• Japan

Pregnenolone

Pregnenolone is reported as an ingredient of Metharmone F in the following countries:

• Japan

International Drug Name Search

Kan-Ophtal

Kan-Ophtal may be available in the countries listed below.

Ingredient matches for Kan-Ophtal

Kanamycin

Kanamycin sulfate (a derivative of Kanamycin) is reported as an ingredient of Kan-Ophtal in the following countries:

• Germany

International Drug Name Search

Libolar

Libolar may be available in the countries listed below.

Ingredient matches for Libolar

Dextromethorphan

Dextromethorphan hydrobromide (a derivative of Dextromethorphan) is reported as an ingredient of Libolar in the following countries:

• Venezuela

International Drug Name Search

Artotec

Artotec may be available in the countries listed below.

Ingredient matches for Artotec

Diclofenac

Diclofenac sodium salt (a derivative of Diclofenac) is reported as an ingredient of Artotec in the following countries:

• France

Misoprostol

Misoprostol is reported as an ingredient of Artotec in the following countries:

• France

International Drug Name Search

Tiklyd

Tiklyd may be available in the countries listed below.

Ingredient matches for Tiklyd

Ticlopidine

Ticlopidine hydrochloride (a derivative of Ticlopidine) is reported as an ingredient of Tiklyd in the following countries:

• Germany


• Portugal

International Drug Name Search

Myconormin

Myconormin may be available in the countries listed below.

Ingredient matches for Myconormin

Terbinafine

Terbinafine hydrochloride (a derivative of Terbinafine) is reported as an ingredient of Myconormin in the following countries:

• Austria


• Germany


• Luxembourg


• Switzerland

International Drug Name Search

Xylocaina Viscosa

Xylocaina Viscosa may be available in the countries listed below.

Ingredient matches for Xylocaina Viscosa

Lidocaine

Lidocaine hydrochloride (a derivative of Lidocaine) is reported as an ingredient of Xylocaina Viscosa in the following countries:

• Argentina


• Chile

International Drug Name Search

Propafen

Propafen may be available in the countries listed below.

Ingredient matches for Propafen

Propafenone

Propafenone hydrochloride (a derivative of Propafenone) is reported as an ingredient of Propafen in the following countries:

• Colombia


• Serbia

International Drug Name Search

Cyclopam

Cyclopam may be available in the countries listed below.

Ingredient matches for Cyclopam

Dicycloverine

Dicycloverine hydrochloride (a derivative of Dicycloverine) is reported as an ingredient of Cyclopam in the following countries:

• India

International Drug Name Search

Tevagrastim

Tevagrastim may be available in the countries listed below.

Ingredient matches for Tevagrastim

Filgrastim

Filgrastim is reported as an ingredient of Tevagrastim in the following countries:

• Slovakia


• Sweden


• Switzerland

International Drug Name Search

Tetramax

Tetramax may be available in the countries listed below.

In some countries, this medicine may only be approved for veterinary use.

Ingredient matches for Tetramax

Oxytetracycline

Oxytetracycline dihydrate (a derivative of Oxytetracycline) is reported as an ingredient of Tetramax in the following countries:

• South Africa

Tetracycline

Tetracycline is reported as an ingredient of Tetramax in the following countries:

• Brazil

International Drug Name Search

Mefenax

Mefenax may be available in the countries listed below.

Ingredient matches for Mefenax

Mefenamic Acid

Mefenamic Acid is reported as an ingredient of Mefenax in the following countries:

• Philippines

International Drug Name Search

Iobrim

Iobrim may be available in the countries listed below.

Ingredient matches for Iobrim

Brimonidine

Brimonidine tartrate (a derivative of Brimonidine) is reported as an ingredient of Iobrim in the following countries:

• India

International Drug Name Search

Isosorbidmononitrat Mylan

Isosorbidmononitrat Mylan may be available in the countries listed below.

Ingredient matches for Isosorbidmononitrat Mylan

Isosorbide Mononitrate

Isosorbide Mononitrate is reported as an ingredient of Isosorbidmononitrat Mylan in the following countries:

• Sweden

International Drug Name Search

LMX4

LMX4 may be available in the countries listed below.

UK matches:

• LMX4 Lidocaine 4% w/w Cream (SPC)
• LMX4 Lidocaine 4% w/w Cream (SPC)

Ingredient matches for LMX4

Lidocaine

Lidocaine is reported as an ingredient of LMX4 in the following countries:

• United Kingdom

International Drug Name Search

Glossary

SPC	Summary of Product Characteristics (UK)

Click for further information on drug naming conventions and International Nonproprietary Names.

Lisitril

Lisitril may be available in the countries listed below.

Ingredient matches for Lisitril

Lisinopril

Lisinopril dihydrate (a derivative of Lisinopril) is reported as an ingredient of Lisitril in the following countries:

• Japan


• Switzerland

International Drug Name Search

Tensotin

Tensotin may be available in the countries listed below.

Ingredient matches for Tensotin

Atenolol

Atenolol is reported as an ingredient of Tensotin in the following countries:

• Oman

International Drug Name Search

Arthotec

Arthotec may be available in the countries listed below.

Ingredient matches for Arthotec

Diclofenac

Diclofenac sodium salt (a derivative of Diclofenac) is reported as an ingredient of Arthotec in the following countries:

• Germany

Misoprostol

Misoprostol is reported as an ingredient of Arthotec in the following countries:

• Germany

International Drug Name Search

Belustine

Belustine may be available in the countries listed below.

Ingredient matches for Belustine

Lomustine

Lomustine is reported as an ingredient of Belustine in the following countries:

• France


• Netherlands

International Drug Name Search

Terolinal

Terolinal may be available in the countries listed below.

Ingredient matches for Terolinal

Lisinopril

Lisinopril dihydrate (a derivative of Lisinopril) is reported as an ingredient of Terolinal in the following countries:

• Greece

International Drug Name Search

Tetracyclin Domesco

Tetracyclin Domesco may be available in the countries listed below.

Ingredient matches for Tetracyclin Domesco

Tetracycline

Tetracycline hydrochloride (a derivative of Tetracycline) is reported as an ingredient of Tetracyclin Domesco in the following countries:

• Vietnam

International Drug Name Search

Ambien

In the US, Ambien (zolpidem systemic) is a member of the drug class miscellaneous anxiolytics, sedatives and hypnotics and is used to treat Insomnia.

US matches:

• Ambien


• Ambien CR Extended-Release Tablets


• Ambien CR

Ingredient matches for Ambien

Zolpidem

Zolpidem tartrate (a derivative of Zolpidem) is reported as an ingredient of Ambien in the following countries:

• Antigua & Barbuda


• Aruba


• Bahamas


• Barbados


• Bermuda


• Cayman Islands


• Haiti


• Hungary


• Jamaica


• Netherlands Antilles


• Saint Lucia


• Saint Vincent & The Grenadines


• United States

International Drug Name Search

Citalopram-Sandoz

Citalopram-Sandoz may be available in the countries listed below.

Ingredient matches for Citalopram-Sandoz

Citalopram

Citalopram hydrobromide (a derivative of Citalopram) is reported as an ingredient of Citalopram-Sandoz in the following countries:

• Austria


• Belgium


• Denmark


• Estonia


• France


• Germany


• Italy


• Luxembourg


• Netherlands


• Spain


• Sweden

Citalopram hydrochloride (a derivative of Citalopram) is reported as an ingredient of Citalopram-Sandoz in the following countries:

• Italy

International Drug Name Search

Ibergal

Ibergal may be available in the countries listed below.

Ingredient matches for Ibergal

Dihydroergotoxine

Dihydroergotoxine mesilate (a derivative of Dihydroergotoxine) is reported as an ingredient of Ibergal in the following countries:

• Greece

International Drug Name Search

Lidocaina + Idrocortisone Zeta

Lidocaina + Idrocortisone Zeta may be available in the countries listed below.

Ingredient matches for Lidocaina + Idrocortisone Zeta

Hydrocortisone

Hydrocortisone is reported as an ingredient of Lidocaina + Idrocortisone Zeta in the following countries:

• Italy

Lidocaine

Lidocaine is reported as an ingredient of Lidocaina + Idrocortisone Zeta in the following countries:

• Italy

International Drug Name Search

Coldistan

Coldistan may be available in the countries listed below.

Ingredient matches for Coldistan

Diphenhydramine

Diphenhydramine hydrochloride (a derivative of Diphenhydramine) is reported as an ingredient of Coldistan in the following countries:

• Austria

Naphazoline

Naphazoline hydrochloride (a derivative of Naphazoline) is reported as an ingredient of Coldistan in the following countries:

• Austria

International Drug Name Search

Cefgram

Cefgram may be available in the countries listed below.

Ingredient matches for Cefgram

Ceftazidime

Ceftazidime pentahydrate (a derivative of Ceftazidime) is reported as an ingredient of Cefgram in the following countries:

• Venezuela

International Drug Name Search

Momegalen

Momegalen may be available in the countries listed below.

Ingredient matches for Momegalen

Mometasone

Mometasone 17-(2-furoate) (a derivative of Mometasone) is reported as an ingredient of Momegalen in the following countries:

• Germany

International Drug Name Search

Acido Salicilico Sella

Acido Salicilico Sella may be available in the countries listed below.

Ingredient matches for Acido Salicilico Sella

Salicylic Acid

Salicylic Acid is reported as an ingredient of Acido Salicilico Sella in the following countries:

• Italy

International Drug Name Search

Ivytimol

Ivytimol may be available in the countries listed below.

Ingredient matches for Ivytimol

Timolol

Timolol maleate (a derivative of Timolol) is reported as an ingredient of Ivytimol in the following countries:

• Ethiopia

International Drug Name Search

Tusso Rhinathiol

Tusso Rhinathiol may be available in the countries listed below.

Ingredient matches for Tusso Rhinathiol

Dextromethorphan

Dextromethorphan hydrobromide (a derivative of Dextromethorphan) is reported as an ingredient of Tusso Rhinathiol in the following countries:

• Belgium


• Luxembourg

International Drug Name Search

Rea-Lo

In the US, Rea-Lo is a member of the drug class topical emollients and is used to treat Dermatological Disorders, Dry Skin and Pityriasis rubra pilaris.

Ingredient matches for Rea-Lo

Urea

Urea is reported as an ingredient of Rea-Lo in the following countries:

• United States

International Drug Name Search

Famodyl

Famodyl may be available in the countries listed below.

Ingredient matches for Famodyl

Famotidine

Famotidine is reported as an ingredient of Famodyl in the following countries:

• Dominican Republic

International Drug Name Search

Amoxilan

Amoxilan may be available in the countries listed below.

Ingredient matches for Amoxilan

Amoxicillin

Amoxicillin trihydrate (a derivative of Amoxicillin) is reported as an ingredient of Amoxilan in the following countries:

• Austria


• Venezuela

International Drug Name Search

Exmate

Exmate may be available in the countries listed below.

Ingredient matches for Exmate

Polystyrene Sulfonic Acid

Polystyrene Sulfonic Acid calcium salt (a derivative of Polystyrene Sulfonic Acid) is reported as an ingredient of Exmate in the following countries:

• Japan

International Drug Name Search

Tolbanasin

Tolbanasin may be available in the countries listed below.

Ingredient matches for Tolbanasin

Tofisopam

Tofisopam is reported as an ingredient of Tolbanasin in the following countries:

• Japan

International Drug Name Search

Amiobutols

Amiobutols may be available in the countries listed below.

Ingredient matches for Amiobutols

Ethambutol

Ethambutol dihydrochloride (a derivative of Ethambutol) is reported as an ingredient of Amiobutols in the following countries:

• Latvia

International Drug Name Search

Cimal

Cimal may be available in the countries listed below.

Ingredient matches for Cimal

Citalopram

Citalopram is reported as an ingredient of Cimal in the following countries:

• Ecuador

Citalopram hydrobromide (a derivative of Citalopram) is reported as an ingredient of Cimal in the following countries:

• Chile

International Drug Name Search

Amavita Xylometazolin

Amavita Xylometazolin may be available in the countries listed below.

Ingredient matches for Amavita Xylometazolin

Xylometazoline

Xylometazoline hydrochloride (a derivative of Xylometazoline) is reported as an ingredient of Amavita Xylometazolin in the following countries:

• Switzerland

International Drug Name Search

Conclyte-Mg

Conclyte-Mg may be available in the countries listed below.

Ingredient matches for Conclyte-Mg

Magnesium Sulfate

Magnesium Sulfate is reported as an ingredient of Conclyte-Mg in the following countries:

• Japan

International Drug Name Search

CardioGen-82

Ingredient matches for CardioGen-82

Rubidium Rb82

Rubidium Rb82 hydrochloride (a derivative of Rubidium Rb82) is reported as an ingredient of CardioGen-82 in the following countries:

• United States

International Drug Name Search

Cefovell

Cefovell may be available in the countries listed below.

Ingredient matches for Cefovell

Cefotaxime

Cefotaxime sodium salt (a derivative of Cefotaxime) is reported as an ingredient of Cefovell in the following countries:

• Indonesia

International Drug Name Search

Katen

Katen may be available in the countries listed below.

Ingredient matches for Katen

Mexiletine

Mexiletine hydrochloride (a derivative of Mexiletine) is reported as an ingredient of Katen in the following countries:

• Czech Republic

International Drug Name Search

Robervital

Robervital may be available in the countries listed below.

Ingredient matches for Robervital

Oxaceprol

Oxaceprol is reported as an ingredient of Robervital in the following countries:

• Spain

Tocopherol, α-

Tocopherol, α- succinate (a derivative of Tocopherol, α-) is reported as an ingredient of Robervital in the following countries:

• Spain

International Drug Name Search

Kemanat

Kemanat may be available in the countries listed below.

Ingredient matches for Kemanat

Ketorolac

Ketorolac tromethamine (a derivative of Ketorolac) is reported as an ingredient of Kemanat in the following countries:

• Argentina

International Drug Name Search

Euglitol

Euglitol may be available in the countries listed below.

Ingredient matches for Euglitol

Miglitol

Miglitol is reported as an ingredient of Euglitol in the following countries:

• India

International Drug Name Search

Cromax

Cromax may be available in the countries listed below.

Ingredient matches for Cromax

Cromoglicic Acid

Cromoglicic Acid disodium salt (a derivative of Cromoglicic Acid) is reported as an ingredient of Cromax in the following countries:

• Colombia

International Drug Name Search

Altus

Altus may be available in the countries listed below.

Ingredient matches for Altus

Sildenafil

Sildenafil is reported as an ingredient of Altus in the following countries:

• Peru

International Drug Name Search

Rectiofar

Rectiofar may be available in the countries listed below.

Ingredient matches for Rectiofar

Glycerol

Glycerol is reported as an ingredient of Rectiofar in the following countries:

• Vietnam

International Drug Name Search

Atacand HCT

In the US, Atacand HCT (candesartan/hydrochlorothiazide systemic) is a member of the drug class antihypertensive combinations and is used to treat High Blood Pressure.

US matches:

• Atacand HCT

Ingredient matches for Atacand HCT

Candesartan

Candesartan cilexetil (a derivative of Candesartan) is reported as an ingredient of Atacand HCT in the following countries:

• United States

Hydrochlorothiazide

Hydrochlorothiazide is reported as an ingredient of Atacand HCT in the following countries:

• Slovakia


• United States

International Drug Name Search

Ipnolor

Ipnolor may be available in the countries listed below.

Ingredient matches for Ipnolor

Lormetazepam

Lormetazepam is reported as an ingredient of Ipnolor in the following countries:

• Italy

International Drug Name Search

Ferrofumaraat PCH

Ferrofumaraat PCH may be available in the countries listed below.

Ingredient matches for Ferrofumaraat PCH

Ferrous Fumarate

Ferrous Fumarate is reported as an ingredient of Ferrofumaraat PCH in the following countries:

• Netherlands

International Drug Name Search

Kenalog Intra-articular / Intramuscular Injection

1. Name Of The Medicinal Product

Kenalog Intra-articular / Intramuscular Injection

2. Qualitative And Quantitative Composition

Kenalog Intra-articular / Intramuscular Injection contains triamcinolone acetonide 40mg per ml of sterile suspension.

3. Pharmaceutical Form

Sterile aqueous suspension for injection.

4. Clinical Particulars

4.1 Therapeutic Indications

Intra-articular use: for alleviating the joint pain, swelling and stiffness associated with rheumatoid arthritis and osteoarthrosis, with an inflammatory component; also for bursitis, epicondylitis, and tenosynovitis.

Intramuscular use: Where sustained systemic corticosteroid treatment is required: Allergic states, e.g. bronchial asthma, seasonal or perennial allergic rhinitis. In seasonal allergies, patients who do not respond to conventional therapy may achieve a remission of symptoms over the entire period with a single intramuscular injection (see Dosage); Endocrine disorders, e.g. primary or secondary adrenocortical insufficiency. Collagen disorders, e.g. during an exacerbation of maintenance therapy of selected cases of SLE or acute rheumatic carditis; Dermatological diseases, e.g. pemphigus, severe dermatitis and Stevens Johnson Syndrome; Rheumatic, Gastrointestinal or Respiratory disorders - as an adjunctive, short-term therapy; Haematological disorders, e.g. acquired (autoimmune) haemolytic anaemia; Neoplastic diseases, e.g. palliative management of leukaemia and lymphomas; Renal disease, such as acute interstitial nephritis, minimal change nephrotic syndrome or lupus nephritis.

4.2 Posology And Method Of Administration

Kenalog is for Intra-articular/Intramuscular injection. The safety and efficacy of administration by other routes has yet to be established. Strict aseptic precautions should be observed. Since the duration of effect is variable, subsequent doses should be given when symptoms recur and not at set intervals.

Intra-Articular Injection: For intra-articular administration or injection into tendon sheaths and bursae, the dose of Kenalog Injection may vary from 5mg to 10mg (0.125 - 0.25ml) for smaller joints and up to 40mg (1.0ml) for larger joints, depending on the specific disease entity being treated. Single injections into several sites for multiple joint involvement, up to a total of 80mg, have been given without undue reactions.

It is recommended that, when injections are given into the sheaths of short tendons, Adcortyl Injection (triamcinolone acetonide 10mg/ml) should be used. (See under Precautions, re Achilles tendon).

Intramuscular Injection: To avoid the danger of subcutaneous fat atrophy, it is important to ensure that deep intramuscular injection is given into the gluteal site. The deltoid should not be used. Alternate sides should be used for subsequent injections.

Adults and Children over 12 Years: The suggested initial dose is 40mg (1.0ml) injected deeply into the upper, outer quadrant of the gluteal muscle. Subsequent dosage depends on the patient's response and period of relief. Patients with hay fever or pollen asthma who do not respond to conventional therapy may obtain a remission of symptoms lasting throughout the pollen season after a single dose of 40-100mg given when allergic symptoms appear. (See Warnings and Precautions.)

Elderly: Treatment of elderly patients, particularly if long term, should be planned bearing in mind the more serious consequences of the common side effects of corticosteroids in old age, especially osteoporosis, diabetes, hypertension, susceptibility to infection and thinning of the skin. Close clinical supervision is required to avoid life-threatening reactions.

Children from 6-12 Years of Age: The suggested initial dose of 40mg (1.0ml injected deeply into the gluteal muscle should be scaled according to the severity of symptoms and the age and weight of the child. Kenalog is not recommended for children under six years. Growth and development of children on prolonged corticosteroid therapy should be carefully observed. Caution should be used in the event of exposure to chickenpox, measles or other communicable diseases. (See 4.4 Special Warnings and Special Precautions for Use.)

Triamcinolone withdrawal: In patients who have received more than physiological doses of Kenalog (more than one injection during a three week period), withdrawal should not be abrupt. The dose should be reduced and the dosage interval increased until a dose of not more than 40mg and a dosage interval of at least three weeks have been achieved as the dose of systemic corticosteroid is reduced. Clinical assessment of disease activity may be needed.

Abrupt withdrawal of short term systemic corticosteroid treatment is appropriate if it is considered that the disease is unlikely to relapse. A single dose, which is not repeated within a three week period, is unlikely to lead to clinically relevant hpa-axis suppression in the majority of patients. However, in the following patient groups, gradual withdrawal of systemic corticosteroid therapy should always be considered:

Patients who have had repeated courses of systemic corticosteroids.

When a course of Kenalog has been prescribed within one year of cessation of long-term therapy (months or years).

Patients who may have reasons for adrenocortical insufficiency other than exogenous corticosteroid therapy.

4.3 Contraindications

Hypersensitivity to any of the ingredients.

Systemic infections unless specific anti-infective therapy is employed.

Administration by intravenous, intrathecal or intraocular injection.

4.4 Special Warnings And Precautions For Use

Warnings

Adequate studies to demonstrate the safety of Kenalog use by intra-turbinal, subconjunctival, sub-tenons, retrobulbar and intraocular (intravitreal) injections have not been performed. Endophthalmitis, eye inflammation, increased intraocular pressure and visual disturbances including vision loss have been reported with intravitreal administration. Several instances of blindness have been reported following injection of corticosteroid suspensions into the nasal turbinates and intralesional injection about the head.

(Intra-Articular Injection):

Corticosteroids should not be injected into unstable joints.

Patients should be specifically warned to avoid over-use of joints in which symptomatic benefit has been obtained. Severe joint destruction with necrosis of bone may occur if repeated intra-articular injections are given over a long period of time. Care should be taken if injections are given into tendon sheaths to avoid injection into the tendon itself. Repeated injection into inflamed tendons should be avoided as it has been shown to cause tendon rupture.

Due to the absence of a true tendon sheath, the Achilles tendon should not be injected with depot corticosteroids.

(Intramuscular Injection):

During prolonged therapy a liberal protein intake is essential to counteract the tendency to gradual weight loss sometimes associated with negative nitrogen balance and wasting of skeletal muscle.

Precautions:

Intra-articular injection should not be carried out in the presence of active infection in or near joints. The preparation should not be used to alleviate joint pain arising from infectious states such as gonococcal or tubercular arthritis.

Undesirable effects may be minimised using the lowest effective dose for the minimum period, and by administering the daily requirement, whenever possible, as a single morning dose on alternate days. Frequent patient review is required to titrate the dose appropriately against disease activity. (See dosage section).

Adrenal cortical atrophy develops during prolonged therapy and may persist for years after stopping treatment. Withdrawal of corticosteroids after prolonged therapy must, therefore, always be gradual to avoid acute adrenal insufficiency and should be tapered off over weeks or months according to the dose and duration of treatment. During prolonged therapy any intercurrent illness, trauma or surgical procedure will require a temporary increase in dosage. If corticosteroids have been stopped following prolonged therapy they may need to be reintroduced temporarily.

Patients should carry steroid treatment cards which give clear guidance on the precautions to be taken to minimise risk and which provide details of prescriber, drug, dosage and the duration of treatment.

Suppression of the inflammatory response and immune function increases the susceptibility to infections and their severity. The clinical presentation may often be atypical and serious infections such as septicaemia and tuberculosis may be masked and may reach an advanced stage before being recognised.

Chickenpox and measles are of particular concern since these normally minor illnesses may be fatal in immunosuppressed patients.

Unless they have had chickenpox, patients receiving parenteral corticosteroids for purposes other than replacement should be regarded as being at risk of severe chickenpox. Manifestations of fulminant illness include pneumonia, hepatitis and disseminated intravascular coagulation; rash is not necessarily a prominent feature. Passive immunisation with varicella zoster immunoglobulin (VZIG) is needed by exposed non- immune patients who are receiving systemic corticosteroids or who have used them within the previous 3 months; varicella-zoster immunoglobulin should preferably be given within 3 days of exposure and not later than 10 days. Confirmed chickenpox warrants specialist care and urgent treatment. Corticosteroids should not be stopped and the dose may need to be increased.

Patients should be advised to avoid exposure to measles and to seek medical advice without delay if exposure occurs. Prophylaxis with normal immunoglobulin may be needed.

During corticosteroid therapy antibody response will be reduced and therefore affect the patient's response to vaccines. Live vaccines should not be administered.

Patients and/or carers should be warned that potentially severe psychiatric adverse reactions may occur with systemic steroids (see section 4.8). Symptoms typically emerge within a few days or weeks of starting the treatment. Risks may be higher with high doses/systemic exposure (see also section 4.5 pharmacokinetic interactions that can increase the risk of side effects), although dose levels do not allow prediction of the onset, type, severity or duration of reactions. Most reactions recover after either dose reduction or withdrawal, although specific treatment may be necessary. Patients/carers should be encouraged to seek medical advice if worrying psychological symptoms develop, especially if depressed mood or suicidal ideation is suspected. Patients/carers should also be alert to possible psychiatric disturbances that may occur either during or immediately after dose tapering/withdrawal of systemic steroids, although such reactions have been reported infrequently.

Particular care is required when considering the use of systemic corticosteroids in patients with existing or previous history of severe affective disorders in themselves or in their first degree relatives. These would include depressive or manic-depressive illness and previous steroid psychosis.

Special Precautions:

Particular care is required when considering use of systemic corticosteroids in patients with the following conditions and frequent patient monitoring is necessary.

Recent intestinal anastomoses, diverticulitis, thrombophlebitis, existing or previous history of severe affective disorders (especially previous steroid psychosis), exanthematous disease, chronic nephritis, or renal insufficiency, metastatic carcinoma, osteoporosis (post-menopausal females are particularly at risk); in patients with an active peptic ulcer (or a history of peptic ulcer). Myasthenia gravis. Latent or healed tuberculosis; in the presence of local or systemic viral infection, systemic fungal infections or in active infections not controlled by antibiotics. In acute psychoses; in acute glomerulonephritis. Hypertension; congestive heart failure; glaucoma (or a family history of glaucoma), previous steroid myopathy or epilepsy. Liver failure.

Corticosteroid effects may be enhanced in patients with hypothyroidism or cirrhosis and decreased in hyperthyroid patients.

Diabetes may be aggravated, necessitating a higher insulin dosage. Latent diabetes mellitus may be precipitated.

Menstrual irregularities may occur, and this possibility should be mentioned to female patients.

Rare instances of anaphylactoid reactions have occurred in patients receiving corticosteroids, especially when a patient has a history of drug allergies.

All corticosteroids increase calcium excretion

Aspirin should be used cautiously in conjunction with corticosteroids in patients with hypoprothrombinaemia.

This product contains 15mg/ml benzyl alcohol and must not be given to premature babies or neonates. Benzyl Alcohol may cause toxic reactions and anaphylactoid reactions in infants and children up to 3 years old.

Use in Children:

Kenalog is not recommended for children under six years. Corticosteroids cause dose-related growth retardation in infancy, childhood and adolescence which may be irreversible, therefore growth and development of children on prolonged corticosteroid therapy should be carefully observed.

Use in Elderly:

The common adverse effects of systemic corticosteroids may be associated with more serious consequences in old age, especially osteoporosis, hypertension, hypokalaemia, diabetes, susceptibility to infection and thinning of the skin. Close clinical supervision is required to avoid life-threatening reactions.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Amphotericin B injection and potassium-depleting agents: Patients should be observed for hypokalaemia.

Anticholinesterases: Effects of anticholinesterase agent may be antagonised.

Anticoagulants, oral: Corticosteroids may potentiate or decrease anticoagulant action. Patients receiving oral anticoagulants and corticosteroids should therefore be closely monitored.

Antidiabetics: Corticosteroids may increase blood glucose; diabetic control should be monitored, especially when corticosteroids are initiated, discontinued, or changed in dosage.

Antihypertensives, including diuretics: corticosteroids antagonise the effects of antihypertensives and diuretics. The hypokalaemic effect of diuretics, including acetazolamide, is enhanced.

Anti-tubercular drugs: Isoniazid serum concentrations may be decreased.

Cyclosporin: Monitor for evidence of increased toxicity of cyclosporin when the two are used concurrently.

Digitalis glycosides: Co-administration may enhance the possibility of digitalis toxicity.

Oestrogens, including oral contraceptives: Corticosteroid half-life and concentration may be increased and clearance decreased.

Hepatic Enzyme Inducers (e.g. barbiturates, phenytoin, carbamazepine, rifampicin, primidone, aminoglutethimide): There may be increased metabolic clearance of Kenalog. Patients should be carefully observed for possible diminished effect of steroid, and the dosage should be adjusted accordingly.

Human growth hormone: The growth-promoting effect may be inhibited.

Ketoconazole: Corticosteroid clearance may be decreased, resulting in increased effects.

Nondepolarising muscle relaxants: Corticosteroids may decrease or enhance the neuromuscular blocking action.

Nonsteroidal anti-inflammatory agents (NSAIDS): Corticosteroids may increase the incidence and/or severity of GI bleeding and ulceration associated with NSAIDS. Also, corticosteroids can reduce serum salicylate levels and therefore decrease their effectiveness. Conversely, discontinuing corticosteroids during high-dose salicylate therapy may result in salicylate toxicity. Aspirin should be used cautiously in conjunction with corticosteroids in patients with hypoprothrombinaemia.

Thyroid drugs: Metabolic clearance of adrenocorticoids is decreased in hypothyroid patients and increased in hyperthyroid patients. Changes in thyroid status of the patient may necessitate adjustment in adrenocorticoid dosage.

Vaccines: Neurological complications and lack of antibody response may occur when patients taking corticosteroids are vaccinated. (See 4.4 Special Warnings and Special Precautions for Use.)

4.6 Pregnancy And Lactation

The ability of corticosteroids to cross the placenta varies between individual drugs, however triamcinolone does cross the placenta.

Administration of corticosteroids to pregnant animals can cause abnormalities of foetal development including cleft palate, intra-uterine growth retardation and effects on brain growth and development. There is no evidence that corticosteroids result in an increased incidence of congenital abnormalities, such as cleft palate / lip in man. However, when administered for prolonged periods or repeatedly during pregnancy, corticosteroids may increase the risk of intra-uterine growth retardation. Hypoadrenalism may, in theory, occur in the neonate following prenatal exposure to corticosteroids but usually resolves spontaneously following birth and is rarely clinically important.

As with all drugs, corticosteroids should only be prescribed when the benefits to the mother and child outweigh the risks. When corticosteroids are essential, however, patients with normal pregnancies may be treated as though they were in the non-gravid state.

Lactation

Corticosteroids may pass into breast milk, although no data are available for triamcinolone. Infants of mothers taking high doses of systemic corticosteroids for prolonged periods may have a degree of adrenal suppression.

4.7 Effects On Ability To Drive And Use Machines

None known.

4.8 Undesirable Effects

Where adverse reactions occur they are usually reversible on cessation of therapy. The incidence of predictable side-effects, including hypothalamic-pituitary-adrenal suppression correlate with the relative potency of the drug, dosage, timing of administration and duration of treatment. (See Warnings and Precautions).

Absorption of triamcinolone following injection by the intra-articular route is rare. However, patients should be watched closely for the following adverse reactions which may be associated with any corticosteroid therapy:

Anti-inflammatory and immunosuppressive effects: Increased susceptibility and severity of infections with suppression of clinical symptoms and signs, opportunistic infections, recurrence of dormant tuberculosis. (See Warnings and Precautions).

Fluid and electrolyte disturbances: sodium retention, fluid retention, congestive heart failure in susceptible patients, potassium loss, cardiac arrhythmias or ECG changes due to potassium deficiency, hypokalaemic alkalosis, increased calcium excretion and hypertension.

Musculoskeletal: muscle weakness, fatigue, steroid myopathy, loss of muscle mass, osteoporosis, avascular osteonecrosis, vertebral compression fractures, delayed healing of fractures, aseptic necrosis of femoral and humeral heads, pathological fractures of long bones and spontaneous fractures, tendon rupture.

Hypersensitivity: Anaphylactic reactions, angiodema, rash, pruritus and urticaria, particularly where there is a history of drug allergies.

Dermatological: impaired wound healing, thin fragile skin, petechiae and ecchymoses, facial erythema, increased sweating, purpura, striae, hirsutism, acneiform eruptions, lupus erythematous-like lesions and suppressed reactions to skin tests.

Gastrointestinal: dyspepsia, peptic ulcer with possible subsequent perforation and haemorrhage, pancreatitis, abdominal distension and ulcerative oesophagitis, candidiasis.

Neurological: euphoria, psychological dependence, depression, insomnia, convulsions, increased intracranial pressure with papilloedema (pseudo-tumour cerebri) usually after treatment, vertigo, headache, neuritis or paraesthesias and aggravation of pre

A wide range of psychiatric reactions including affective disorders (such as irritable, euphoric, depressed and labile mood, and suicidal thoughts), psychotic reactions (including mania, delusions, hallucinations, and aggravation of schizophrenia), behavioural disturbances, irritability, anxiety, sleep disturbances, and cognitive dysfunction including confusion and amnesia have been reported. Reactions are common and may occur in both adults and children. In adults, the frequency of severe reactions has been estimated to be 5-6%. Psychological effects have been reported on withdrawal of corticosteroids; the frequency is unknown.

Endocrine: menstrual irregularities and amenorrhoea; development of the Cushingoid state; suppression of growth in childhood and adolescence; secondary adrenocortical and pituitary unresponsiveness, particularly in times of stress (e.g. trauma, surgery or illness); decreased carbohydrate tolerance; manifestations of latent diabetes mellitus and increased requirements for insulin or oral hypoglycaemic agents in diabetes, weight gain. Negative protein and calcium balance. Increased appetite.

Ophthalmic: posterior subcapsular cataracts, increased intraocular pressure, glaucoma, exophthalmos, papilloedema, corneal or scleral thinning, exacerbation of ophthalmic viral or fungal diseases.

Others: necrotising angiitis, thrombophlebitis, thromboembolism, leucocytosis, insomnia and syncopal episodes.

Withdrawal Symptoms and Signs:

On withdrawal, fever, myalgia, arthralgia, rhinitis, conjunctivitis, painful itchy skin nodules and weight loss may occur. Too rapid a reduction in dose following prolonged treatment can lead to acute adrenal insufficiency, hypotension and death. (See Warnings and Precautions.)

Intra-Articular Injection:

Reactions following intra-articular administration have been rare. In a few instances, transient flushing and dizziness have occurred. Local symptoms such as post-injection flare, transient pain, irritation, sterile abscesses, hyper- or hypo-pigmentation, Charcot-like arthropathy and occasional increase in joint discomfort may occur. Local fat atrophy may occur if the injection is not given into the joint space, but is temporary and disappears within a few weeks to months.

Intramuscular Injection:

Severe pain has been reported following intramuscular administration. Sterile abscesses, cutaneous and subcutaneous atrophy, hyperpigmentation, hypopigmentation and Charcot-like arthropathy have also occurred.

4.9 Overdose

Not applicable.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Triamcinolone acetonide is a synthetic glucocorticoid with marked anti-inflammatory and anti-allergic actions.

Intra-Articular Injection: Following local injection, relief of pain and swelling and greater freedom of movement are usually obtained within a few hours.

Intramuscular Injection: Provides an extended duration of therapeutic effect and fewer side effects of the kind associated with oral corticosteroid therapy, particularly gastro-intestinal reactions such as peptic ulceration. Studies indicate that, following a single intramuscular dose of 80mg triamcinolone acetonide, adrenal suppression occurs within 24 - 48 hours and then gradually returns to normal, usually in approximately three weeks. This finding correlates closely with the extended duration of therapeutic action of triamcinolone acetonide.

5.2 Pharmacokinetic Properties

Triamcinolone acetonide may be absorbed into the systemic circulation from synovial spaces. However clinically significant systemic levels after intra-articular injection are unlikely to occur except perhaps following treatment of large joints with high doses. Systemic effects do not ordinarily occur with intra-articular injections when the proper techniques of administration and the recommended dosage regimens are observed.

Triamcinolone acetonide is absorbed slowly, though almost completely, following depot administration by deep intramuscular injection; biologically active levels are achieved systemically for prolonged periods (weeks to months). In common with other corticosteroids, triamcinolone is metabolised largely hepatically but also by the kidney and is excreted in urine. The main metabolic route is 6-beta-hydroxylation; no significant hydrolytic cleavage of the acetonide occurs.

In view of the hepatic metabolism and renal excretion of triamcinolone acetonide, functional impairments of the liver or kidney may affect the pharmacokinetics of the drug.

5.3 Preclinical Safety Data

See 4.6 Pregnancy and Lactation.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Benzyl alcohol

Polysorbate 80

Sodium carboxymethylcellulose

Sodium chloride

Water.

6.2 Incompatibilities

The injection should not be physically mixed with other medicinal products.

6.3 Shelf Life

36 months

6.4 Special Precautions For Storage

Do not store above 25°C. Do not freeze. Store in an upright position.

6.5 Nature And Contents Of Container

Carton containing glass vials 5 x 1ml.

6.6 Special Precautions For Disposal And Other Handling

No special handling instructions.

7. Marketing Authorisation Holder

E.R. Squibb & Sons Ltd.

Uxbridge Business Park

Sanderson Road

Uxbridge

Middlesex

UB8 1DH

8. Marketing Authorisation Number(S)

PL 0034/5045R

9. Date Of First Authorisation/Renewal Of The Authorisation

10 July 1986

10. Date Of Revision Of The Text

01 November 2009

Gentamen

Gentamen may be available in the countries listed below.

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Gentamicin

Gentamicin sulfate (a derivative of Gentamicin) is reported as an ingredient of Gentamen in the following countries:

• Italy

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Glucagone

Glucagone may be available in the countries listed below.

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Glucagon

Glucagone (DCIT) is known as Glucagon in the US.

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Glossary

DCIT	Denominazione Comune Italiana

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Glitter-M

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Metformin

Metformin is reported as an ingredient of Glitter-M in the following countries:

• India

Pioglitazone

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• India

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Acetazolamide Sodium

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Acetazolamide

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• United States

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Bezastad

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Bezafibrate

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• Austria

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Mucitux

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Eprazinone

Eprazinone dihydrochloride (a derivative of Eprazinone) is reported as an ingredient of Mucitux in the following countries:

• France

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Plexafer

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Ferrous Sulfate

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• Ethiopia

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Piridoksin

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Pyridoxine

Pyridoxine hydrochloride (a derivative of Pyridoxine) is reported as an ingredient of Piridoksin in the following countries:

• Serbia

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Tiamina Clorhidrato

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Thiamine

Thiamine hydrochloride (a derivative of Thiamine) is reported as an ingredient of Tiamina Clorhidrato in the following countries:

• Chile

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Azithromycin-ratiopharm

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Azithromycin

Azithromycin is reported as an ingredient of Azithromycin-ratiopharm in the following countries:

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Torasemida Combix

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Torasemide

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• Spain

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Hivarif

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Lamivudine

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• Bangladesh

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Mifestad

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Mifepristone

Mifepristone is reported as an ingredient of Mifestad in the following countries:

• Vietnam

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Mecolamin

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Mecobalamin

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Minirin / Ddavp

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Desmopressin

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Tobrasix

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Tobramycin

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Trian

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Levocarnitine

Levocarnitine is reported as an ingredient of Trian in the following countries:

• Greece

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Ethiodized Oil (131I)

Scheme

Rec.INN

CAS registry number (Chemical Abstracts Service)

0008008-53-5

Therapeutic Category

Antineoplastic agent, radioactive isotope

Chemical Name

Fatty acids, poppy seed-oil, Et esters, iodinated, labeled with iodine-131

Foreign Name

• Ethiodat [131I]-Öl (German)

Generic Name

• Ethiodized Oil I 131 (OS: USAN)

Brand Names

• Ethiodol
  Savage, United States



• Lipiodol
  Codali, Belgium; Codali, Luxembourg; Guerbet, Austria; Guerbet, Czech Republic; Guerbet, Germany; Guerbet, France; Guerbet, Georgia; Guerbet, Portugal; Guerbet, Romania; Guerbet, Turkey; Rider, Chile; Temis-Lostalo, Argentina



• Lipiodol Ultra Fluid
  Guerbet Laboratoire, Denmark



• Lipiodol Ultra-fluide
  Guerbet, Switzerland

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Glossary

OS	Official Synonym
Rec.INN	Recommended International Nonproprietary Name (World Health Organization)
USAN	United States Adopted Name

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Aristocort

In the US, Aristocort (triamcinolone systemic) is a member of the drug class glucocorticoids and is used to treat Adrenocortical Insufficiency, Allergic Reactions, Ankylosing Spondylitis, Asthma, Berylliosis, Bursitis, Chorioditis, Chorioretinitis, Conjunctivitis, Dermal Necrosis - Prophylaxis, Dermatitis, Erythroblastopenia, Frozen Shoulder, Gouty Arthritis, Hay Fever, Heart Failure, Hemolytic Anemia, Idiopathic Thrombocytopenic Purpura, Iridocyclitis, Iritis, Keratitis, Leukemia, Loeffler's Syndrome, Meningitis, Nephrotic Syndrome, Neuritis, Osteoarthritis, Psoriatic Arthritis, Rheumatoid Arthritis, Sarcoidosis, Synovitis, Systemic Lupus Erythematosus, Thrombocytopenia Idiopathic and Uveitis.

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• Aristocort


• Aristocort A Cream


• Aristocort A


• Aristocort C Concentrate


• Aristocort D Dilute


• Aristocort R Ointment Regular


• Aristocort R Regular

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Triamcinolone

Triamcinolone is reported as an ingredient of Aristocort in the following countries:

• United States

Triamcinolone 16α,17α-acetonide (a derivative of Triamcinolone) is reported as an ingredient of Aristocort in the following countries:

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Aspirin

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• Estonia


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Procisa

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Cisapride

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• India

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Fosmy

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Fosfomycin

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• Japan

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Ilimit

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Aripiprazole

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• Chile


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Fluocid Forte

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Fluocinolone

Fluocinolone Acetonide is reported as an ingredient of Fluocid Forte in the following countries:

• Spain

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Lemesil

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Nimesulide

Nimesulide is reported as an ingredient of Lemesil in the following countries:

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Biocare

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In some countries, this medicine may only be approved for veterinary use.

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Biotin

Biotin is reported as an ingredient of Biocare in the following countries:

• Australia


• United Kingdom

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Cleardent

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Chlorhexidine

Chlorhexidine digluconate (a derivative of Chlorhexidine) is reported as an ingredient of Cleardent in the following countries:

• Israel

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Argaron

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Argatroban

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• Japan

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Apo-Amoxycillin

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Amoxicillin

Amoxicillin trihydrate (a derivative of Amoxicillin) is reported as an ingredient of Apo-Amoxycillin in the following countries:

• Australia

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Histerzin

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Promethazine

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• Bangladesh

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Proslosin

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Tamsulosin

Tamsulosin hydrochloride (a derivative of Tamsulosin) is reported as an ingredient of Proslosin in the following countries:

• Colombia

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Baclofeno

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Baclofen

Baclofen is reported as an ingredient of Baclofeno in the following countries:

• Peru

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Flumicon

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Fluconazole

Fluconazole is reported as an ingredient of Flumicon in the following countries:

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