HEPABIONTA® AMPOULES

INDICATIONS CONTRA-INDICATIONS DOSAGE SIDE-EFFECTS PREGNANCY OVERDOSE IDENTIFICATION PATIENT INFORMATION

HEPABIONTA® AMPOULES

SCHEDULING STATUS:
Schedule 1

PROPRIETARY NAME
(and dosage form):

HEPABIONTA^® AMPOULES

COMPOSITION :
One ampoule HEPABIONTA contains in 2 mL aqueous solution:

Vitamin B1 (Thiamine hydrochloride)	5 mg
Nicotinamide	20 mg
Pantothenyl alcohol	6 mg
Folic acid	1 mg
Vitamin B6 (Pyridoxine hydrochloride)	4 mg
Vitamin B12(Cyanocobalamine)	2500 µg
Orotic acid	10 mg
As preservative: Benzyl alcohol	1% m/v

PHARMACOLOGICAL CLASSIFICATION:
A.7.4. –Lipotropic agents.

PHARMACOLOGICAL ACTION:
In liver disease simultaneous administration of the active principle contained in HEPABIONTA gives optimum support and relieves the disturbed metabolism in liver cells; furthermore it provides favourable preconditions for the regeneration of the damaged liver parenchyma. The main modes of action of the various components can be summarised as follows: HEPABIONTA supports liver functions, protects the liver, promotes the restoration of the parenchyma, and improves detoxification.

INDICATIONS:
HEPABIONTA is a combination of metabolising vitamins for the therapy of liver parenchyma disease. It has proved valuable in the treatment of acute and chronic hepatitis, of the post-hepatic syndrome of liver cirrhosis, of alcoholic fatty infiltration and of intoxications (alcohol, drugs) or of hepatopathies due to diseases of the biliary duct.

CONTRA-INDICATIONS:
None

WARNINGS:
None.

DOSAGE AND DIRECTIONS FOR USE:
Usually, 1 ampoule of HEPABIONTA given daily to institute therapy: subsequently 1 ampoule 2 - 3 x per week. HEPABIONTA is injected by the deep intramuscular route. Intravenous injection is also possible. HEPABIONTA may, furthermore, be added to the infusions commonly employed in liver therapy.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Since sensitisation against the Vitamin B₁ contained is possible, intravenous administration of HEPABIONTA should be made cautiously. For this reason intravenous injections and infusions have to be given slowly and the patient observed for possible allergic reactions.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
None.

CONDITIONS OF REGISTRATION:
None.

IDENTIFICATION:
Clear, dark red solution.

PRESENTATION:
Boxes of 5 x 2 mL ampoules.

STORAGE INSTRUCTIONS:
Store at room temperature (15° - 25°C).
Keep all medicines out of reach of children.

REFERENCE NUMBER:
H607 (Act 101/1965).

NAME AND BUSINESS ADDRESS OF THE APPLICANT:
Merck (Pty) Ltd
Reg No. 70/04059/07
11 Fedlife Park, Tonetti Street
Midrand l685

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
December 1, 1974.

Manufacturer:

E. Merck, Darmstadt, West Germany.	F17106
^® = Registered Trademark	91D0591
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