Source: Health Products Regulatory Authority (ZA) Revision Year: 2023 Publisher: PHARMACARE LIMITED, Healthcare Park, Woodlands Drive, Woodmead, 2191
TRACTINFECT is indicated:
The recommended dose for uncomplicated urinary tract infections in women, including the elderly up to seventy-five years, is a single 3 g dose.
The recommended dose for prophylaxis prior to transurethral surgical and diagnostic procedures and for perioperative antibiotic prophylaxis for transrectal prostate biopsy in adult men, including the elderly, is two doses of 3 g. The first dose should be taken three hours before surgery or procedure. The second dose should be taken twenty-four hours after surgery or procedure.
TRACTINFECT in a dose of 3 g is not suitable for children under the age of 12 years.
For oral administration.
TRACTINFECT should be taken on an empty stomach, either 1 hour before or at least 2 hours after meals and preferably before bedtime after emptying the bladder.
For instructions on reconstitution of the medicine before administration, see section 6.6.
Appearance of the product dissolved in water: clear to slightly opalescent, white solution, orange flavoured, free from undissolved particles.
The following events have been observed those who have taken fosfomycin in overdose: vestibular loss, impaired hearing, metallic taste and general decline in taste perception.
In the event of overdose, treatment should be symptomatic and supportive. Urinary elimination of the medicine can be accelerated through adequate administration of oral fluids.
36 months.
The reconstituted solution should be used immediately.
Store at or below 25°C.
The powder is packed in sachets made of paper, low density polyethylene and aluminium foil.
Each sachet is packed in an outer cardboard carton.
No special requirements.
The contents of a sachet should be dissolved in a glass of water and taken immediately after its preparation.
Appearance of the product dissolved in water: clear to slightly opalescent, white solution, orange flavoured, free from undissolved particles.
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