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

Logo NEUROBION® AMPOULES

SCHEDULING STATUS:
Schedule 1

PROPRIETARY NAME
(and dosage form):

NEUROBION® AMPOULES

COMPOSITION:
Each 3 mL ampoule contains:
  Vitamin B1 100 mg
  Vitamin B6 100 mg
  Vitamin B12 1 mg
  Benzyl alcohol (preservative) 1% v/v
PHARMACOLOGICAL CLASSIFICATION:
A.22.1.4 - Vitamins: Others

INDICATIONS:
NEUROBION Ampoules are indicated where a deficiency of the relevant vitamins exist.

CONTRA-INDICATIONS:
NEUROBION should not be used in patients on Levodopa therapy.

Hypersensitivity to any of the active ingredients.

DOSAGE AND DIRECTIONS FOR USE:
NEUROBION Ampoules are preferably injected intramuscularly (deep intragluteal). In severe cases 1 ampoule daily until the acute symptoms subside. For milder cases and follow-up therapy 2 or 3 ampoules per week.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Cyanocobalamin should not be given before a diagnosis has been fully established because of the possibility of masking symptoms of subacute degeneration of the spinal cord. Cyanocobalamin is not a suitable form of Vitamin B12 for the treatment of optic neuropathies associated with raised plasma concentrations of cyanocobalamin.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Treatment is symptomatic and supportive.

IDENTIFICATION:
Clear, red solution with no visible particles.

PRESENTATION:
Boxes of 3 ampoules of 3 mL each.

STORAGE INSTRUCTIONS:
Keep out of reach of children.
Store below 25°C

REFERENCE NUMBER:
H2488 (Act 101/1965)

NAME AND BUSINESS ADDRESS OF THE APPLICANT:
Merck (Pty) Ltd.
Reg. No. 70/04059/07
11 Fedlife Park
Tonetti Street, Midrand 1685

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
11 March 1988

® Registered Trade Mark
F22306
94C0397

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