ZIDOVAL Vaginal gel Ref.[50031] Active ingredients: Methronidazole

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2018  Publisher: Mylan Products Ltd, Station Close, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom

4.1. Therapeutic indications

Zidoval vaginal gel is indicated for the treatment of bacterial vaginosis.

4.2. Posology and method of administration

Posology

For vaginal administration.

Adults

One application of Zidoval vaginal gel (5g) inserted into the vagina once daily, at bedtime, for 5 consecutive days.

Elderly

Bacterial vaginosis is not commonly seen in the elderly population and consequently clinical assessment in this age group has not been carried out.

Pediatric population

Not recommended for use in children and adolescents under 18 years since safety and efficacy have not been established.

Method of administration

Pierce sealed end of tube and screw open end of applicator tightly onto tube of gel. Squeeze tube, filling the applicator with gel. Remove applicator from tube and gently insert applicator into vagina as far as it will comfortably go. Push the plunger to release the gel. Dispose of applicator as instructed.

4.9. Overdose

There is no human experience of overdosage with Zidoval vaginal gel. There is no specific treatment. Metronidazole is readily removed from the plasma by haemodialysis.

6.3. Shelf life

3 years.

6.4. Special precautions for storage

Do not store above 25°C.

6.5. Nature and contents of container

Aluminium tubes lined with an epoxy phenolic resin with polyethylene screw caps containing 40 g product. The product is packaged with 5 disposable vaginal applicators, each to deliver 5 g of gel.

6.6. Special precautions for disposal and other handling

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

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