Heptral powder lyophilized for solution for injection

国: アルメニア

言語: 英語

ソース: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

有効成分:

ademetionine

から入手可能:

BIOLOGICI ITALIA LABORATORIES S.R.L.

ATCコード:

A16AA02

INN（国際名）:

ademetionine

投薬量:

400mg

医薬品形態:

powder lyophilized for solution for injection

パッケージ内のユニット:

(5) glass vials and (5) solvent in ampoules 5ml

処方タイプ:

Prescription

認証ステータス:

Registered

承認日:

2021-05-17

製品の特徴

Abbott
Confidential
Information
This information is
confidential
SUMMARY OF PRODUCT CHARACTERISTICS
ADEMETIONINE
1
NAME OF THE MEDICINAL PRODUCT
Heptral 400 mg/5 ml lyophilized powder and solvent
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Heptral 400 mg/5ml lyophilized powder and solvent
One vial of lyophilized powder contains 760 mg ademetionine
1,4-butanedisulfonate equivalent to
400 mg Ademetionine

3
PHARMACEUTICAL FORM
Heptral 400 mg/5 ml Lyophilized powder and solvent
Lyophilized powder:
White to yellowish lyophilized cake
Solvent:
Clear, colourless to yellow solution
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.
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.
The lyophilized powder for IM or IV administration should be dissolved
using the accompanying
solvent at the time of use. Discard unused portion. The appropriate
dose of ademetionine for IV
administration should be further diluted in 250 ml saline or 5%
dextrose and infused slowly within
1 to 2 hours. Ademetionine should not be mixed with an alkaline or
calcium ion-containing
solution. If the lyophilized powder appears other than wh