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

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, sodium hydroxide) is available in 500 mg/5 mL vials for intravenous and intramuscular injection. The lyophilized powder should be dissolved using the accompanying solvent at the time of use. Discard unused portion.

Ademetionine should not be mixed with an alkaline or calcium ion-containing solution. If the lyophilized powder appears other than white to yellowish in color (due to a crack in the vial or exposure to heat), the product should not be used.

Intravenous ademetionine should be administered slow IV.

Tablets

Ademetionine tablets are available in 500 mg strength. Ademetionine tablets should be swallowed whole and not chewed. For better absorption of the active ingredient and complete therapeutic effect, ademetionine tablets should not be taken with meals.

Ademetionine tablets should be extracted from the blister package immediately before use. If the tablets appear other than white to yellowish in color (due to presence of holes in the aluminum wrapper), it is recommended the product not be used.

Intrahepatic cholestasis

Initial therapy

IV or IM: The recommended dosing is 5-12 mg/kg/day IV or IM. The usual starting dose is 500 mg/day IV or IM, total daily dose not to exceed 800 mg, for 2 weeks.

Oral: The recommended dosing is 10-25 mg/kg/day orally. The usual starting dose is 800 mg/day, total daily dose not to exceed 1600mg.

Maintenance therapy

Oral: 800 to 1,600 mg/day.

Pediatric

The safety and efficacy of ademetionine for the use in children has not been established.

Geriatric

Clinical studies of ademetionine did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

Renal Impairment

Studies have not been conducted in patients with renal impairment. Therefore, caution is recommended when administering ademetionine to these patients.

Hepatic Impairment

Pharmacokinetic parameters are similar in healthy volunteers and patients with chronic liver disease.

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.

24 months.

Store at temperatures not exceeding 30°C.

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.

Caution:

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