MURIPOCIN 2% w/w Ointment (2018)
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Περιεχόμενα
Name of the medicinal product
Mupirocin 2% w/w Ointment.
Qualitative and quantitative composition
Each gram of ointment contains 20 mg mupirocin (2% w/w mupirocin). For the full list of excipients, see Section 6.1.
Pharmaceutical form
Ointment in a white, translucent, water-soluble, polyethylene glycol base.
Therapeutic indications
Mupirocin is indicated in adults and children. Mupirocin is a topical antibacterial agent, active against those organisms responsible for the majority of skin infections, e.g. Staphylococcus aureus, including ...
Posology and method of administration
Posology Adults (including elderly) and Paediatric population Mupirocin Ointment should be applied to the affected area up to three times a day for up to 10 days. The area may be covered with a dressing ...
Contraindications
Hypersensitivity to the active substance(s) or to any of the excipients listed in section 6.1 This Mupirocin Ointment formulation is not suitable for ophthalmic or intranasal use.
Special warnings and precautions for use
Should a possible sensitisation reaction or severe local irritation occur with the use of Mupirocin Ointment, treatment should be discontinued, the product should be washed off and appropriate therapy ...
Interaction with other medicinal products and other forms of interaction
No interaction studies have been performed.
Fertility, pregnancy and lactation
Pregnancy Reproduction studies on mupirocin 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, Mupirocin Ointment ...
Effects on ability to drive and use machines
Mupirocin 2% w/w Ointment has no or negligible influence on the ability to drive and use machines.
Undesirable effects
Adverse reactions are listed below by system organ class and frequency. Frequencies are defined as: very common (1/10), common (1/100 to <1/10), uncommon (1/1,000 to <1/100), rare (1/10,000 to <1/1,000), ...
Overdose
Symptoms There is currently limited experience with overdosage of mupirocin. Management The toxicity of mupirocin is very low. In the event of accidental ingestion of the ointment, symptomatic treatment ...
Pharmacodynamic properties
Pharmacotherapeutic group: Antibiotics and chemotherapeutics for topical use ATC code: D06AX09 Mechanism of action Mupirocin is a novel antibiotic produced through fermentation by Pseudomonas fluorescens. ...
Pharmacokinetic properties
After topical application of Mupirocin Ointment, mupirocin is only very minimally absorbed systemically and that which is absorbed is rapidly metabolised to the antimicrobially inactive metabolite, monic ...
Preclinical safety data
Pre-clinical effects were seen only at exposures which are extremely unlikely to cause concern for humans under normal conditions of use. Mutagenicity studies revealed no risks to man.
List of excipients
Macrogol 400 Macrogol 3350
Incompatibilities
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
Shelf life
Shelf life: 2 years. Once open use within six months.
Special precautions for storage
Do not store above 25°C.
Nature and contents of container
15g aluminium tube internally coated with an epoxy non-toxic resin closed with polyethylene screw caps.
Special precautions for disposal and other handling
No special requirements.
Marketing authorization holder
Focus Pharmaceuticals Ltd, Capital House, 85 King William Street, London EC4N 7BL, United Kingdom
Marketing authorization number(s)
PL 20046/0071
Date of first authorization / renewal of the authorization
16/12/2011
Date of revision of the text
05/04/2018
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