Source: Health Products Regulatory Authority (ZA) Publisher: AUROGEN SA (Pty) Ltd, Woodhill Office Park, Building 1, First Floor, 53 Phillip Engelbrecht Avenue, Meyersdal, Ext. 12, 1448, Johannesburg, South Africa
UNITRO is indicated for the treatment and prevention of recurrence of uncomplicated lower urinary tract infections e.g. pyelonephritis, pyelitis and cystitis.
It is not indicated for the treatment of associated renal, cortical or perinephric abscesses.
Acute urinary tract infections: 50 mg to 100 mg four times a day, with meals and at bedtime.
To prevent recurrences: 50 mg to 100 mg per day.
UNITRO may be given with food or milk to further minimise gastric upset. Therapy should be discontinued for at least one week and for at least 3 days after sterility of the urine is obtained. Continued infection indicates need for re-evaluation. Nitrofurantoin is highly soluble in urine, to which it may impart a brown colour.
Acute urinary tract infections: Should be calculated on the basis of 5 to 7 mg/kg of body mass per 24 hours to be given in divided doses four times a day (contraindicated for children under one month)
To prevent recurrences: 1 mg/kg/day for long-term therapy.
UNITRO is administered orally.
Symptoms and signs of overdose include gastric irritation, nausea and vomiting. Treatment is symptomatic and supportive (see section 4.7).
24 months.
The capsules should be stored in light-resistant and preferably, moisture-proof containers.
Store at or below 25°C.
KEEP OUT OF REACH OF CHILDREN.
a) Clear 250 micron PVC – Aluminium foil blister pack:
Blister pack comprises of clear thermoformable 250 micron PVC film as the forming film and printed 25 micron Aluminium foil as the lidding material.
Pack Sizes: 50’s: Printed cardboard carton containing 5 blisters of 10 capsules each.
b) White Opaque 250 micron PVC film – Aluminium foil blister pack:
Blister pack comprises of white opaque thermoformable rigid 250 micron PVC film as the forming film and printed 25 micron Aluminium foil as the lidding material.
Pack Sizes: 50’s: Printed cardboard carton containing 5 blisters of 10 capsules each.
UNITRO 50:
White opaque round 40 mL HDPE container with 33 mm neck finish closed with white opaque 33 mm – 400 polypropylene continuous thread closure with wad having Tekniplex HS 123 induction sealing liner.
Pack size: 50’s.
UNITRO 100:
White opaque round 60 mL HDPE container with 33 mm neck finish closed with white opaque 33 mm – 400 polypropylene continuous thread closure with wad having Tekniplex HS 123 induction sealing liner.
Pack size: 50’s.
No special requirements.
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