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SPC, UK: BACTROBAN Nasal ointment (2016)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

Bactroban 2% Nasal Ointment.

Qualitative and quantitative composition

Each gram of nasal ointment contains mupirocin calcium equivalent to 20 mg mupirocin (2% w/w mupirocin free acid).

Pharmaceutical form

White soft paraffin based nasal ointment containing a glycerin ester. Off-white smooth ointment.

Therapeutic indications

The elimination of nasal carriage of staphylococci, including methicillin resistant Staphylococcus aureus (MRSA).

Posology and method of administration

Posology Adults (including the elderly) and children Bactroban Nasal Ointment should be applied to the anterior nares two to three times a day as follows: A small amount of the ointment about the size ...

Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

Special warnings and precautions for use

Should a possible sensitisation reaction or severe local irritation occur with the use of Bactroban Nasal Ointment, treatment should be discontinued, the product should be wiped away and appropriate therapy ...

Interaction with other medicinal products and other forms of interaction

No drug interactions have been identified.

Fertility, pregnancy and lactation

Pregnancy Reproduction studies on Bactroban in animals have revealed no evidence of harm to the foetus (see section 5.3). As there is no clinical experience on its use during pregnancy, Bactroban should ...

Effects on ability to drive and use machines

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

Undesirable effects

Adverse reactions are listed below by system organ class and frequency. Frequencies are defined as: very common (≥1/10), common (≥1/100, <1/10), uncommon (≥1/1000, <1/100), rare (≥1/10,000, <1/1000), very ...

Overdose

Symptoms and signs There is currently limited experience with overdosage of mupirocin. Treatment There is no specific treatment for an overdose of mupirocin. In the event of overdose, the patient should ...

Pharmacodynamic properties

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

Pharmacokinetic properties

Studies have shown that following topical application of mupirocin there is very little systemic absorption of drug-related material. To mimic possible enhanced systemic penetration of mupirocin by application ...

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

White soft paraffin Softisan 649

Incompatibilities

None known.

Shelf life

Shelf life: 3 years.

Special precautions for storage

Store at room temperature (below 25°C).

Nature and contents of container

Lacquered aluminium tube fitted with a nozzle and screw cap containing 3 g ointment.

Special precautions for disposal and other handling

Any product remaining at the end of treatment should be discarded. Any unused medicinal product or waste material should be disposed of in accordance with local requirements. 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 00038/0347

Date of first authorization / renewal of the authorization

Date of first authorisation: 7 March 1988 Date of last renewal: 21 May 2008

Date of revision of the text

26 September 2016

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