Heptral tablets gastro-resistant

Nchi: Armenia

Lugha: Kiingereza

Chanzo: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Viambatanisho vya kazi:

ademetionine

Inapatikana kutoka:

AbbVie S.r.l.

ATC kanuni:

A16AA02

INN (Jina la Kimataifa):

ademetionine

Kipimo:

400mg

Dawa fomu:

tablets gastro-resistant

Vitengo katika mfuko:

(20/2x10/) in blister

Dawa ya aina:

Prescription

Idhini hali ya:

Registered

Idhini ya tarehe:

2021-10-08

Tabia za bidhaa

Abbott
Confidential
Information
This information is
confidential
SUMMARY OF PRODUCT CHARACTERISTICS
ADEMETIONINE
1
NAME OF THE MEDICINAL PRODUCT
Heptral 400 mg, gastro-resistant tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Heptral 400 mg tablets
One tablet contains 400 mg of Ademetionine.

3
PHARMACEUTICAL FORM
Heptral 400 mg , gastro-resistant tablets
Practically white to yellowish, oval tablet, free from foreign
particles
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Heptral is indicated for treatment of adults with:
•
Intrahepatic cholestasis in pre-cirrhotic and cirrhotic states
•
Intrahepatic cholestasis in pregnancy
•
Depressive symptoms
•
Relief of Fatigue Caused by Chronic Liver Disease
•
Prevention and Treatment of Drug-induced liver injury (DILI)
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Treatment is usually started with parenteral administration of the
drug and continued using the drug
in the form of tablets or immediately with the use of tablets. 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. Heptral 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.
Depression
_Initial therapy _
IV or IM: The recommended dosing is 5-12 mg/kg/day. The usual starting
dose is 400 mg/day IV or
IM, total daily dose not to exceed 1000 mg. Duration of initial
parenteral therapy is 15-20 days.
Oral: The recommended dosing is 10-25 mg/kg/day orally. The usual
starting dose is 400-800
mg/day, total daily dose not to exceed 1600 mg.
_Maintenance therapy_
Oral: 500 - 1600 mg/day.
Intrahepatic cholestasis/Fatigue in Chronic Liver disease/Prevention
and Treatment of Druginduced
liver injury (DILI)
_Initial therapy _
IV or IM: The recommended dosing