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SPC, Ireland: AULIN Gel (2010)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

Aulin 3% w/w Gel.

Qualitative and quantitative composition

Aulin 3% w/w gel contains 3% w/w nimesulide (1 g of gel contains 30 mg of nimesulide). Excipients: Methyl parahydroxybenzoate 0.80% w/w Propyl parahydroxybenzoate 0.02% w/w For a full list of excipients, ...

Pharmaceutical form

Gel. Opalescent, pale yellow gel.

Therapeutic indications

Symptomatic relief of pain associated with sprains and acute traumatic tendinitis.

Posology and method of administration

Adults Nimesulide 3% w/w gel (usually 3 g, corresponding to a line 6-7 cm long) should be applied in a thin layer to the affected area 2-3 times daily and massaged until it is completely absorbed. Duration ...

Contraindications

Known hypersensitivity to nimesulide or to any other excipients in the gel. Use in patients in whom aspirin, or other medicinal products inhibiting prostaglandin synthesis, induced allergic reactions such ...

Special warnings and precautions for use

Nimesulide 3% w/w gel should not be applied to skin wounds or open injuries. Nimesulide 3% w/w gel should not be allowed to come into contact with the eyes or mucous membranes; in case of accidental contact, ...

Interaction with other medicinal products and other forms of interaction

No interactions of Nimesulide 3% w/w gel with other medicinal products are known or to be expected via the topical route.

Pregnancy and lactation

There are no data relevant to the topical use of Nimesulide 3% w/w gel in pregnant women or during breastfeeding. Therefore, Nimesulide 3% w/w gel should not be used during pregnancy or lactation unless ...

Effects on ability to drive and use machines

No studies on the effect of Nimesulide 3% w/w gel on the ability to drive and use machines have been performed.

Undesirable effects

The following side effects listing is based on reports from clinical studies, in a limited number of patients, where mild local reactions have been reported. The reporting rates are classified as: very ...

Overdose

Intoxication with nimesulide as a result of topical application of Nimesulide 3% w/w gel is not to be expected since the highest plasma levels of nimesulide following application of Nimesulide gel are ...

Pharmacodynamic properties

Pharmacotherapeutic group: Non-steroidal anti-inflammatory drug (NSAID) for topical use ATC code: M02AA Nimesulide is an inhibitor of the prostaglandin synthesis enzyme cyclo-oxygenase. Cyclo-oxygenase ...

Pharmacokinetic properties

When Nimesulide 3% w/w gel is applied topically, plasma concentrations of nimesulide are very low in comparison with those achieved following oral intake. After a single application of 200mg of nimesulide, ...

Preclinical safety data

The local tolerance and the irritation and sensitisation potential of Nimesulide 3% w/w gel have been tested in several recognised animal models. The results of these studies indicate that Nimesulide 3% ...

List of excipients

Purified Water Diethylene glycol monoethyl ether Caprylcaproyl macrogol glycerides Carbomers Disodium edetate Triethanolamine Methyl parahydroxybenzoate (E218) Propyl parahydroxybenzoate (E216)

Incompatibilities

Not applicable.

Shelf life

Shelf life: 2 years.

Special precautions for storage

Do not store above 30°C.

Nature and contents of container

15g, 30g, 50g and 100 g aluminium tubes lined with lacquer made of an epoxyphenolic resin and closed with a polypropylene cap. Not all pack sizes may be marketed.

Special precautions for disposal and other handling

Wash hands after use.

Marketing authorization holder

Helsinn Birex Pharm. Limited, Damastown, Mulhuddart, Dublin 15, Ireland

Marketing authorization number(s)

PA 0294/018/003

Date of first authorization / renewal of the authorization

Date of first authorisation: 10 December 1999 Date of last renewal: 10 December 2009

Date of revision of the text

March 2010

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