País: África do Sul
Língua: inglês
Origem: South African Health Products Regulatory Authority (SAHPRA)
Sad-otc
AURALYT® (EAR DROPS) SCHEDULING STATUS: S1 PROPRIETARY NAME (and dosage form): AURALYT ® (EAR DROPS) COMPOSITION: Each 1 mL contains: Glycerin dehydrated to make 1,0 mL Antipyrine 54,0 mg Benzocaine 14,0 mg PRESERVATIVE: Oxyquinoline sulphate 0,0376% m/v PHARMACOLOGICAL CLASSIFICATION: A.16.2 Aural preparations, ear drops. PHARMACOLOGICAL ACTION: AURALYT® has analgesic (pain-relieving) local anaesthetic and hygroscopic properties. INDICATIONS: AURALYT® is indicated for the relief of pain and reduction of inflammation in the congestive and serious stages of otitis media (middle ear infection), also for relief of discomfort in acute stages of "swimmers ear". It is especially useful for children and in facilitating the removal of excessive impacted cerumen (ear wax). AURALYT® is also indicated as adjuvant therapy when other medicines such as antibiotics or sulphonamides are administered systemically for ear infection. CONTRA-INDICATIONS: Known hypersensitivity (allergy) to any of the ingredients or para-aminobenzoic acid and its derivatives or hydroxybenzoate preservatives. AURALYT® should not be used in conditions with ear discharge or perforated tympanic membrane (pierced eardrum). WARNINGS: Do not use if solution is brown or contains a precipitate. Discard this medicine six months after opening bottle. Discontinue promptly if sensitization (allergic reaction) or irritation occurs. DOSAGE AND DIRECTIONS FOR USE: Otitis media (middle ear infection): Instil AURALYT® permitting the solution to run along the wall of the canal, until it is filled. Avoid touching the ear with the dropper. Then moisten a cotton pledget with AURALYT® and insert into meatus. Repeat every one to two hours until pain and congestion are relieved. Removal of cerumen (ear wax): Instil AURALYT® three tim Leia o documento completo