Země: Jihoafrická republika
Jazyk: angličtina
Zdroj: South African Health Products Regulatory Authority (SAHPRA)
Aspen-p
BETNESOL® SCHEDULING STATUS: S4 777075STSA/2M PROPRIETARY NAME (and dosage form): BETNESOL ® Eye, Ear and Nose Drops COMPOSITION: Each 100 mL contains betamethasone sodium phosphate 0,1 g in a sterile stabilised solution. Contains benzalkonium chloride 0,02% m/v as preservative. PHARMACOLOGICAL CLASSIFICATION: A.15.2 Ophthalmic preparations with corticosteroids. PHARMACOLOGICAL ACTION: BETNESOL Eye, Ear and Nose Drops contain the water-soluble corticosteroid betamethasone sodium phosphate, and have the advantage of containing no steroid particles to cause irritation. This is of particular value in ophthalmic work. INDICATIONS: Eye conditions: Non-infected inflammatory conditions such as non-specific keratitis, conjunctival allergies and acute or chronic uveitis. Ear conditions: Inflammatory conditions of the ear such as otitis externa. Nose conditions: Hayfever, vasomotor and non-seasonal allergic rhinitis. CONTRA-INDICATIONS: Viral, bacterial, fungal, tuberculous and purulent infections. Possibility of herpetic keratitis. Glaucoma. Hypersensitivity to any component of the preparation. BETNESOL Eye, Ear and Nose Drops contain benzalkonium chloride as a preservative and therefore should not be used to treat patients who wear soft contact lenses. Corticosteroids have been shown to be teratogenic in animals following dermal application. As these agents are absorbed percutaneously, teratogenicity following topical application cannot be excluded. Therefore, BETNESOL Eye, Ear and Nose Drops should not be used during pregnancy. DOSAGE AND DIRECTIONS FOR USE: EYE: One or two drops to be instilled into the eye every one or two hours until control is achieved, when the frequency may be reduced. EAR: Two to three drops to be instilled into the ear every two or three hours until Přečtěte si celý dokument