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 50, Hard gelatin capsules.
UNITRO 100, Hard gelatin capsules.
| Pharmaceutical Form |
|---|
|
UNITRO 50: Hard gelatin capsules of size ‘4’ with white opaque body imprinted with ‘50’ and yellow opaque cap imprinted with ‘NMC’ with black ink, filled with yellow to light yellow granular powder. UNITRO 100: Hard gelatin capsules of size ‘2’ with yellow opaque body imprinted with ‘100’ and yellow opaque cap imprinted with ‘NMC’ with black ink, filled with yellow to light yellow granular powder. |
UNITRO 50: Each capsule contains 50 mg nitrofurantoin. Sugar free.
UNITRO 100: Each capsule contains 100 mg nitrofurantoin. Sugar free.
For full list of excipients, see section 6.1.
| Active Ingredient |
|---|
|
Nitrofurantoin is a broad spectrum antibacterial agent, active against the majority of urinary pathogens. It is bactericidal in renal tissue and throughout the urinary tract. The wide range of organisms sensitive to the bacterial activity include Escherichia coli, Enteroccus faecalis, Klebsiella species, Enterobacter species, Staphylococcus species: (e.g. S. aureus, S. saprophyticus, S. epidermidis). |
| List of Excipients |
|---|
|
Capsules content: Nitrofurantoin Capsules shell: Iron oxide yellow (E172) Composition of the ink: Shellac |
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.
AUROGEN SA (Pty) Ltd, Woodhill Office Park, Building 1, First Floor, 53 Phillip Engelbrecht Avenue, Meyersdal, Ext. 12, 1448, Johannesburg, South Africa
UNITRO 50 55/18.5/207
UNITRO 100 55/18.5/208
Date of first authorization: 01 FEBRUARY 2022
| Drug | Countries | |
|---|---|---|
| UNITRO | South Africa |
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