(and dosage form):
Each 100,00 mL contains:
Thiomersal 100,00 mg
Alcohol 50,00% v/v
A 13.1 Antiseptics and cleansing agents.
Thiomersalate Tincture may be used as an antiseptic for application to wounds, denuded surfaces, asepsis of skin prior to surgery, first aid treatment of contaminated wounds and in athletes foot infection.
Hypersensitivity to the ingredients. It should be used with caution on broken skin.
DIRECTIONS FOR USE:
For external use only.
Apply to the affected area as required.
SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
This preparation may cause the development of erythematous, papular or vesicular eruptions over the area of application in individuals who are hypersensitive to Thiomersal type compounds. Discontinue use if these side-effects occur.
KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Following ingestion, the immediate symptoms include a metallic taste, thirst, severe abdominal pain, vomiting, ashy discolouration of the mouth and pharynx and bloody diarrhoea.
Thiomersalate is not likely to cause acute poisoning because it is poorly absorbed following oral ingestion.
Acute poisoning due to ingestion should be treated by immediate gastric aspiration and lavage preferably using 250 mL of a 5% solution of sodium formaldehyde sulphoxylate and leaving a further 100 to 200 mL in the stomach. Large quantities of milk or charcoal may also be given. Dimercaprol therapy should be started immediately. Water and electrolytes lost by vomiting and diarrhoea should be replaced. A purgative such as sodium sulphate 30 g in 250 mL of water may be given.
A bright fluorescent orange solution.
Bottles of 20 mL, 50 mL, 100 mL, 500 mL, 2,5 litres and 5 litres.
Store below 25°C.
KEEP OUT OF REACH OF CHILDREN.
G1461 (Act 101/1965).
NAME AND BUSINESS ADDRESS OF APPLICANT:
South African Druggists Limited
DATE OF PUBLICATION OF THIS PACKAGE INSERT:
New on this site: December 2001
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