DALACIN CREAM Vaginal Cream Ref.[6728] Active ingredients: Clindamycin

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2021  Publisher: Pfizer Limited, Ramsgate Road, Sandwich, Kent, CT13 9NJ, United Kingdom

Therapeutic indications

Antibiotic for the treatment of bacterial vaginosis.

Posology and method of administration

Posology

One applicator full intravaginally at bedtime for 7 consecutive days.

In patients for whom a shorter treatment course is desirable, a 3 day regimen has been shown to be effective.

Paediatric population

Safety and efficacy in paediatric patients have not been established (see section 4.4).

Elderly

No clinical studies have been conducted in populations older than 60.

Overdose

There are no reports of overdose with clindamycin. Vaginally applied clindamycin phosphate vaginal cream 2% can be absorbed in sufficient amounts to produce systemic effects.

In the event of overdosage, general symptomatic and supportive measures are indicated as required.

Accidental oral intake can lead to effects comparable with those of therapeutic concentrations of orally administered clindamycin.

Shelf life

2 years.

Special precautions for storage

Do not store above 25°C. Do not freeze.

Nature and contents of container

Laminate tube (consisting of LMDPE and aluminium foil) with polypropylene cap containing 7.8 g, 20 g or 40 g cream, packed in cardboard carton, together with a leaflet.

Not all pack sizes may be marketed.

Special precautions for disposal and other handling

No special requirements.

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