ARROW ORNIDAZOLE Film coated tablet Ref.[9715] Active ingredients: Ornidazole

Source: Medicines and Medical Devices Safety Authority (NZ)  Revision Year: 2018  Publisher: SPONSOR: Teva Pharma (New Zealand) Limited, PO Box 128 244, Remuera, Auckland 1541, Telephone: 0800 800 097

Product name and form

Arrow – Ornidazole, 500 mg, film coated tablet.

Pharmaceutical Form

White to slightly yellowish, cylindrical, biconvex film coated tablets.

Qualitative and quantitative composition

Each tablet contains 500 mg of ornidazole.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Ornidazole

Ornidazole is indicated for the treatment of Bacterial vaginosis. It is effective against Trichomonas vaginalis, Entamoeba histolytica and Giardia lamblia (Giardia intestinalis), and also against certain anaerobic bacteria such as Bacteroides and Clostridium spp., Fusobacterium spp., and anaerobic cocci.

List of Excipients

Maize starch
Microcrystalline cellulose
Hydroxypropylmethylcellulose
Magnesium stearate
Talc
Titanium dioxide

Pack sizes and marketing

PVC/Aluminium foil blister packs. Pack size of 10 tablets.

Not all pack types or pack sizes may be marketed.

Marketing authorization holder

SPONSOR: Teva Pharma (New Zealand) Limited, PO Box 128 244, Remuera, Auckland 1541, Telephone: 0800 800 097

Marketing authorization dates and numbers

Date of first approval: 17 March 2011

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