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ALTARGO Ointment (2019)

Αναφορές

Βιβλιογραφική αναφορά

Για την προβολή της πλήρους καταχώρησης απαιτείται συνδρομή σε ισχύ.
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Περιεχόμενα

Name of the medicinal product

Altargo 10 mg/g ointment.

Qualitative and quantitative composition

Each gram of ointment contains 10 mg retapamulin (1% w/w). Excipient(s) with known effect: Each gram of ointment contains up to 20 micrograms of butylated hydroxytoluene (E321). For the full list of excipients, ...

Pharmaceutical form

Ointment. Smooth, off-white ointment.

Therapeutic indications

Short term treatment of the following superficial skin infections in adults, adolescents, infants and children (aged from nine months) (see section 5.1): Impetigo. Infected small lacerations, abrasions, ...

Posology and method of administration

Posology Adults (aged 18-65 years), adolescents (aged 12-17 years), infants and children (aged from nine months to 11 years) A thin layer of ointment should be applied to the affected area twice daily ...

Contraindications

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

Special warnings and precautions for use

Sensitisation or severe local irritation In the event of a sensitisation or severe local irritation from the use of retapamulin ointment, treatment should be discontinued, the ointment carefully wiped ...

Interaction with other medicinal products and other forms of interaction

The effect of concurrent application of retapamulin and other topical medicinal products to the same area of skin has not been studied, and is not recommended. In human liver microsomes, retapamulin was ...

Pregnancy and lactation

Pregnancy No clinical data on exposed pregnancies are available. Animal studies have shown reproductive toxicity after oral administration and are insufficient with respect to effects on parturition and ...

Effects on ability to drive and use machines

Altargo has no or negligible influence on the ability to drive and use machines.

Undesirable effects

Summary of the safety profile In clinical studies in which 2150 patients with superficial skin infections applied Altargo, the most commonly reported adverse reaction was application site irritation, which ...

Overdose

Any signs or symptoms of overdose, either topically or by accidental ingestion, should be treated symptomatically. No specific antidote is known.

Pharmacodynamic properties

Pharmacotherapeutic group: Antibiotics and chemotherapeutics for dermatological use, Antibiotics for topical use. ATC code: D06AX13 Mechanism of action Retapamulin is a semi-synthetic derivative of the ...

Pharmacokinetic properties

Absorption Healthy adults In a study conducted in healthy adult subjects, 10 mg/g retapamulin ointment was applied daily to intact and to abraded skin under occlusion for up to 7 days. Systemic exposure ...

Preclinical safety data

Repeated-dose toxicity In 14-day (50, 150 or 450 mg/kg) oral toxicity studies in rats there was evidence of adaptive hepatic and thyroid changes. Neither of these findings is of clinical relevance. In ...

List of excipients

White soft paraffin Butylated hydroxytoluene (E321)

Incompatibilities

Not applicable.

Shelf life

Unopened tube and sachet: 2 years. In-use tube: 7 days.

Special precautions for storage

Do not store above 25°C.

Nature and contents of container

0.5 g aluminium foil sachet. Carton of 12 sachets. 5 g, 10 g and 15 g aluminium tubes with a plastic screw cap. Carton of 1 tube. Not all pack sizes may be marketed.

Special precautions for disposal and other handling

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

Marketing authorization holder

Glaxo Group Ltd, 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom

Marketing authorization number(s)

EU/1/07/390/001 EU/1/07/390/002 EU/1/07/390/003 EU/1/07/390/004

Date of first authorization / renewal of the authorization

Date of first authorisation: 24 May 2007 Date of latest renewal: 20 April 2012

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