INDICATIONS
CONTRA-INDICATIONS
DOSAGE
SIDE-EFFECTS
PREGNANCY
OVERDOSE
IDENTIFICATION
PATIENT INFORMATION
LABETHICA THIAMINE HYDROCHLORIDE INJECTION
SCHEDULING STATUS:
S1
PROPRIETARY NAME
(and dosage form):
LABETHICA THIAMINE HYDROCHLORIDE INJECTION
COMPOSITION:
Thiamine hydrochloride 100 mg/mL.
Preservatives:
Methyl Hydroxybenzoate 0,066% m/v.
Propyl Hydroxybenzoate 0,03% m/v.
PHARMACOLOGICAL CLASSIFICATION:
A 22.1.4
PHARMACOLOGICAL ACTION:
Thiamine is the principal member of the "B" group vitamins, essential in human nutrition. Gross deficiency leads to beri-beri.
INDICATIONS:
Thiamine is administered to counteract deficiency states and specifically by injection, when vomiting or diarrhoea make the oral route ineffective or in the cardiac failure stage of beri-beri.
CONTRA-INDICATIONS:
None
DOSAGE AND DIRECTIONS FOR USE:
Prophylactic, 2 to 5 mg daily; therapeutic, 25 to 100 mg daily. S/C or I/M only.
SIDE EFFECTS AND SPECIAL PRECAUTIONS:
Large doses may interfere with the metabolism of other B–vitamins and precipitate the symptoms of other deficiency states in poorly nourished patients. The risk of anaphylactic shock increases with repeated administration by the parenteral route.
KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Toxic reactions have been produced by injections of 50 mg and sudden death has been reported following the intravenous injection of 100 mg. Symptoms of overdosage subside on withdrawal.
IDENTIFICATION:
A clear, colourless solution in amber glass vials.
PRESENTATION:
Vials of 10 mL.
STORAGE INSTRUCTIONS:
Store below 25°C. Protect from light.
Keep out of reach of children.
REGISTRATION NUMBER:
H.2479 (Act 101 of 1965)
NAME OF APPLICANT AND BUSINESS ADDRESS:
LABETHICA (Pty.) Ltd.
10 Lindley Street
9700 Bethlehem
DATE OF PUBLICATION OF THIS PACKAGE INSERT:
March 1975 12-440/4-89
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