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DALACIN CREAM Vaginal Cream (2021)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

Dalacin Cream 2%.

Qualitative and quantitative composition

Each gram of cream contains clindamycin phosphate equivalent to 20 mg or 2.0% w/w clindamycin. Each applicator full of 5 grams of vaginal cream contains approximately 100 mg of clindamycin phosphate. ...

Pharmaceutical form

Vaginal Cream. White, semi-solid.

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 ...

Contraindications

Dalacin Cream is contra-indicated in patients with a history of hypersensitivity to clindamycin, lincomycin, or to any of the excipients listed in section 6.1. Dalacin Cream 2% is also contraindicated ...

Special warnings and precautions for use

Before or after initiation of therapy with clindamycin, other infections including <em>Trichomonas vaginalis</em>, <em>Candida albicans</em>, <em>Chlamydia trachomatis</em> and <em>gonococcal</em> infections ...

Interaction with other medicinal products and other forms of interaction

Systemic clindamycin has been shown to have neuromuscular blocking properties that may enhance the action of other neuromuscular blocking agents. Therefore, it should be used with caution in patients receiving ...

Fertility, pregnancy and lactation

Pregnancy Use of clindamycin is not recommended during the first trimester, as there are no adequate and well-controlled studies in pregnant women over this period. In clinical trials, intravaginal use ...

Effects on ability to drive and use machines

The effect of clindamycin on the ability to drive or operate machinery has not been systematically evaluated.

Undesirable effects

The table below lists the adverse reactions identified through clinical trial experience and post-marketing surveillance by system organ class and frequency. Adverse reactions identified from post-marketing ...

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, ...

Pharmacodynamic properties

<b>Pharmacotherapeutic group:</b> Gynaecological anti-infectives and antiseptics <b>ATC Code:</b> G01AA10 Mechanism of action Clindamycin is a lincosamide antibiotic that inhibits bacterial protein synthesis ...

Pharmacokinetic properties

Following a once a day intravaginal dose of 100 mg of clindamycin phosphate vaginal cream 2%, administered to 6 healthy female volunteers for 7 days, approximately 4% (range 0.6% to 11%) of the administered ...

Preclinical safety data

Impairment of fertility Fertility studies in rats treated orally with up to 300 mg/kg/day (31 times the human exposure based on mg/m²) revealed no effects on fertility or mating ability. Pregnancy In oral ...

List of excipients

Sorbitan stearate Polysorbate 60 Propylene glycol (E1520) Stearic acid Cetostearyl alcohol Cetyl palmitate Liquid paraffin Benzyl alcohol (E1519) Water

Incompatibilities

Not applicable.

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.

Marketing authorization holder

Pfizer Limited, Ramsgate Road, Sandwich, Kent, CT13 9NJ, United Kingdom

Marketing authorization number(s)

PL 00057/0960

Date of first authorization / renewal of the authorization

Date of first authorisation: 27 April 1993 Date of latest renewal 7<sup>th</sup> August 2009

Date of revision of the text

05/2021

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