Negara: Armenia
Bahasa: Inggris
Sumber: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
aceclofenac
Gedeon Richter PLC
M02AA25
aceclofenac
15mg/g
cream
60g aluminium tube
OTC
Registered
2022-03-01
1. NAME OF THE MEDICINAL PRODUCT AIRTAL ® 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 15 mg aceclofenac in 1 g of cream. Excipients with known effect: 0.20 g of methyl-parahydroxybenzoate (E218) in 100 g of cream, 0.05 g of propyl-parahydroxybenzoate (E216) in 100 g of cream, cetyl-stearyl-alcohol. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Cream. White cream. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of all types of local pain and inflammation of different locomotor origin, including traumatic injuries. It can be used for the alleviation of inflammation of tendons, ligaments, muscles and joints, in case of sprain, overstrain, or contusion, as well as for the treatment of lumbago, torticollis, and periarthritis. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION This product is for external use only and must not be used under occlusive bandages. Airtal cream should be applied three times daily, by gently massaging into the affected area. The applied dose depends on the size of affected area: 1.5-2 g of Airtal cream (it is approximately a strip of 5-7 cm of cream). There is no experience in the use of Airtal cream IN CHILDREN; therefore, Airtal cream is contraindicated in children. No dosage adjustment is required in the elderly. 4.3 CONTRAINDICATIONS Hypersensitivity to the active substance (aceclofenac) or to any of the excipients listed in section 6.1. It should not be given to patients who have shown hypersensitivity to other NSAIDs. Even though possible cross hypersensitivity with diclofenac has not been established, application is not recommended to those patients who have demonstrated hypersensitivity to diclofenac. As with other non-steroidal anti-inflammatory drugs, aceclofenac is contraindicated in patients in whom acetylsalicylic acid or other non-steroidal anti-inflammatory drugs caused asthmatic attacks, urticaria or acute rhinitis. Childhood. 2 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE If the use of Airtal cream produces symptoms of loc Baca dokumen lengkapnya