TRANSMETIL Tablet / Powder for solution for injection Ref.[27974] Active ingredients: Ademetionine

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

Product name and form

Transmetil.

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 active ingredient is the salt, ademetionine 1,4-butanedisulfonate (ademetionine SD4).

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) 1,4-butanedisulfonate 949 mg equivalent to 500 mg Ademetionine

Solution for Injection

Each ampoule contains:

L-lysine 428 mg
Sodium hydroxide 14.4 mg
Water for Injection q.s. 5 mL

Active Ingredient Description
Ademetionine

Ademetionine is a naturally occurring amino acid present in virtually all body tissues and fluids. Ademetionine functions primarily as a co-enzyme and donor transfer of the methyl group (transmethylation) is an essential metabolic process in humans and animals. Ademetionine is also a precursor in the formation of physiological sulfurated compounds (cysteine, taurine, glutathione, CoA, etc.) via transsulfuration. It is used for the treatment of intrahepatic cholestasis.

List of Excipients

Pack sizes and marketing

Tablet: Alu/Alu blister pack of 10’s in a box.

Solution for injection: One (1) box contains: Type 1 clear glass vial (as active) x 5’s + EP Type 1 clear glass ampoule in 5 mL (net content) (as diluents) x 5’s.

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 (Transmetil) 500mg powder for solution for injection:

Manufactured by: Famar L’Aigle, Rue de I’Isle, 28380 Saint-Remy sur Avre, France

Imported by: Abbott Laboratories, Venice Corporate Center, 8 Turin St., Mckinley Town Center, Fort Bonifacio, Taguig City, Philippines

Drugs

Drug Countries
TRANSMETIL Estonia

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