TRANSMETIL Tablet / Powder for solution for injection

Βιβλιογραφική αναφορά

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Περιεχόμενα

1. Name of the medicinal product

Transmetil.

2. Qualitative and quantitative composition

Tablet Each enteric-coated tablet contains 949 mg of ademetionine butanedisulfonate equivalent to 500 mg Ademetionine. Lyophilized Powder for Injection Each vial contains: Ademetionine (Sulfo-Adenosyl-L-Methionine) ...

3. Pharmaceutical form

Ademetionine or S-adenosyl-L-methionine, is a derivative of the amino acid methionine. Because of structural instability, stable salt forms of ademetionine are required for its use as an oral drug. The ...

4.1. Therapeutic indications

Ademetionine is indicated for treatment of adults (≥18 years old) with: Intrahepatic cholestasis in pre-cirrhotic and cirrhotic states. Intrahepatic cholestasis in pregnancy.

4.2. Posology and method of administration

Treatment can be initiated with parenteral administration and continued orally or initiated orally. Lyophilized Powder Ademetionine lyophilized powder and solvent (water solution for injection, L-lysine, ...

4.3. Contraindications

Ademetionine is contraindicated in patients with genetic defects affecting the methionine cycle and/or causing homocystinuria and/or hyperhomocysteinemia (e.g. cystathionine beta-synthase deficiency, Vitamin ...

4.4. Special warnings and precautions for use

Intravenous ademetionine should be administered slow IV (see DOSAGE AND ADMINISTRATION). Ammonia levels should be monitored in patients with pre-cirrhotic and cirrhotic states of hyperammonemia taking ...

4.5. Interaction with other medicinal products and other forms of interaction

Serotonin syndrome has been reported in a patient taking ademetionine and clomipramine. Therefore, although a potential interaction is postulated, caution is recommended when administering ademetionine ...

4.6. Pregnancy and lactation

Pregnancy The use of high doses of ademetionine in women in the last three months of pregnancy did not lead to any adverse effect. It is advisable to administer ademetionine in the first three months of ...

4.7. Effects on ability to drive and use machines

Some patients may experience dizziness with the use of ademetionine. Patients should be advised not to drive or operate machinery during treatment until they are reasonably certain that ademetionine therapy ...

4.8. Undesirable effects

Clinical Trials Ademetionine was studied in 2434 patients of whom 1983 were exposed to ademetionine with liver disease and 817 patients with depression, in controlled and open trials for up to 2 years. ...

4.9. Overdose

Cases of overdose with ademetionine appear to be rare. Physicians should contact their local poison control centers. In general, patients should be monitored and supportive care provided.

5.1. Pharmacodynamic properties

S-adenosyl-L-methionine (ademetionine) is a naturally occurring amino acid present in virtually all body tissues and fluids. Ademetionine functions primarily as a coenzyme and donor transfer of the methyl ...

5.2. Pharmacokinetic properties

Absorption In humans, following intravenous administration, the ademetionine pharmacokinetic profile is bi-exponential and composed of a rapid apparent distribution phase into the tissues and a terminal ...

5.3. Preclinical safety data

Toxicology studies were performed as single dose and repeat dose in multiple animal species including mouse, rat, hamster and dog of both sexes by the oral, subcutaneous, intravenous, and intramuscular ...

6.3. Shelf life

24 months.

6.4. Special precautions for storage

Store at temperatures not exceeding 30°C.

6.5. Nature and contents of container

Tablet: Alu/Alu blister pack of 10s in a box. Solution for injection: One (1) box contains: Type 1 clear glass vial (as active) x 5s + EP Type 1 clear glass ampoule in 5 mL (net content) ...

6.6. Special precautions for disposal and other handling

Caution: Foods, Drugs, Devices and Cosmetics Act prohibits dispensing without prescription.

7. Marketing authorization holder

Ademetionine butanedisulfonate (Transmetil) 500mg tablet: Manufactured by: AbbVie S.r.L., S.R. 148 Pontina Km. 52 SNC, 04011 Campoverde di Aprilia, Aprilia (LT), Italy Ademetionine butanedisulfonate ...

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