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SPC, UK: BACTROBAN 2% Cream (2015)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

Bactroban 2% cream.

Qualitative and quantitative composition

Each gram of cream contains: 21.5 mg Mupirocin calcium equivalent to 20.0 mg mupirocin. For a full list of excipients, see section 6.1.

Pharmaceutical form

Cream. Bactroban Cream is presented as a white cream of homogeneous appearance.

Therapeutic indications

Bactroban Cream is indicated for the topical treatment of secondarily infected traumatic lesions such as small lacerations, sutured wounds or abrasions (up to 10 cm in length or 100 cm² in area), due to ...

Posology and method of administration

Dosage Adults/children ≥1 year/elderly 3 times a day for up to 10 days, depending on the response. Patients not showing a clinical response within 3 to 5 days should be re-evaluated. The duration of treatment ...

Contraindications

Hypersensitivity to mupirocin or any of the excipients (see section 6.1).

Special warnings and precautions for use

Should a possible sensitisation reaction or severe local irritation occur with the use of Bactroban Cream, treatment should be discontinued, the product should be washed off and appropriate therapy instituted. ...

Interaction with other medicinal products and other forms of interaction

No drug interactions have been identified.

Fertility, pregnancy and lactation

Fertility There are no data on the effects of mupirocin on human fertility. Studies in rats showed no effects on fertility (see section 5.3). Pregnancy Reproduction studies on mupirocin in animals have ...

Effects on ability to drive and use machines

No adverse effects on the ability to drive or operate machinery have been identified.

Undesirable effects

Data from clinical trials was used to determine the frequency of very common to rare undesirable effects. Very rare adverse reactions were primarily determined from post-marketing experience data and therefore ...

Overdose

Symptoms There is currently limited experience with overdosage of Bactroban Cream. Management There is no specific treatment for an overdose of Bactroban Cream. In the event of overdose, the patient should ...

Pharmacodynamic properties

Pharmacotherapeutic group: Dermatologicals, Antibiotics and chemotherapeutics for dermatological use ATC code: D06AX09 Mode of Action Mupirocin is a novel antibiotic produced through fermentation by Pseudomonas ...

Pharmacokinetic properties

Absorption Systemic absorption of mupirocin through intact human skin is low although it may occur through broken/diseased skin. However, clinical trials have shown that when given systemically, it is ...

Preclinical safety data

Pre-clinical effects were seen only at exposures which are extremely unlikely to cause concern for humans under normal conditions of clinical use. Mutagenicity studies revealed no risks to man.

List of excipients

Xanthan gum Liquid paraffin Cetomacrogol 1000 Stearyl alcohol Cetyl alcohol Phenoxyethanol Benzyl alcohol Purified water

Incompatibilities

None known.

Shelf life

Shelf life: 18 months.

Special precautions for storage

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

Nature and contents of container

Squeezable aluminium tubes with a screw cap containing 15 g of white cream.

Special precautions for disposal and other handling

Any product remaining at the end of treatment should be discarded. Wash your hands after application.

Marketing authorization holder

Beecham Group plc, 980 Great West Road, Brentford, Middlesex, TW8 9GS Trading as: GlaxoSmithKline UK, Stockley Park West, Uxbridge, Middlesex, UB11 1BT

Marketing authorization number(s)

PL 00038/0372

Date of first authorization / renewal of the authorization

28 October 1998

Date of revision of the text

9 June 2015

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