País: Nova Zelândia
Língua: inglês
Origem: Medsafe (Medicines Safety Authority)
Dexamethasone sodium metasulfobenzoate 0.076%{relative} equivalent to 0.05% w/v dexamethasone; Framycetin sulfate 0.67%{relative} equivalent to 0.5% framycetin; ; Gramicidin 0.005%{relative}
Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics
Dexamethasone sodium metasulfobenzoate 0.076% w/v (=0.05% w/v dexamethasone)
Ear/eye drops
Active: Dexamethasone sodium metasulfobenzoate 0.076%{relative} equivalent to 0.05% w/v dexamethasone Framycetin sulfate 0.67%{relative} equivalent to 0.5% framycetin Gramicidin 0.005%{relative} Excipient: Citric acid monohydrate Hydrochloric acid Lithium chloride as Lithium chloride solution 50%w/v Methylated spirits Phenethyl alcohol Polysorbate 80 Purified water Sodium citrate dihydrate Sodium hydroxide
Bottle, dropper, glass, 8 mL
Prescription
Prescription
Sanofi Chimie
In the eye: For the short term treatment of steroid responsive conditions of the eye when prophylactic antibiotic treatment is also required, after excluding the presence of fungal or viral disease. In the ear: Otitis externa.
Package - Contents - Shelf Life: Bottle, dropper, glass - 8 mL - 24 months from date of manufacture stored at or below 25°C
1969-12-31
Sofradex CMI NZ 1 SOFRADEX _ _ _FRAMYCETIN SULFATE _ _(FRA-ME-SEE-TIN SUL-FATE)_ _, GRAMICIDIN _ _(GRAMMY-SIGH-DIN)_ _, _ _DEXAMETHASONE _ _(DEX-AR-METH-AR-SONE)_ _ _ CONSUMER MEDICINE INFORMATION (CMI) WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Sofradex. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits . Your doctor or pharmacist has weighed the risks of you using Sofradex against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT USING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. Keep this leaflet with the medicine. You may need to read it again. WHAT SOFRADEX IS USED FOR Sofradex is a medicine used to treat infection or inflammation of the ear or eye. Sofradex contains antibiotics (framycetin sulfate and gramicidin) to kill germs and a corticosteroid (dexamethasone) to stop inflammation, itching and weeping. This medicine is available only with a doctor’s prescription. BEFORE YOU USE IT _WHEN YOU MUST NOT USE IT _ DO NOT USE SOFRADEX IF YOU HAVE AN ALLERGY TO SOFRADEX OR ANY OF THE INGREDIENTS LISTED AT THE END OF THIS LEAFLET. DO NOT USE SOFRADEX IF YOU ARE ALLERGIC TO FRAMYCETIN, GRAMICIDIN OR DEXAMETHASONE. DO NOT USE SOFRADEX IF YOU HAVE: • a hole in your eardrum • viral, fungal or tubercular (nodular) lesions • chicken pox (varicella virus) • vaccinia – a type of virus • pus-containing conditions of the eye or ear • high pressure in the eye (glaucoma) • herpes of the eye (eg dendritic ulcer) • undiagnosed red eye or eyelid swelling DO NOT USE SOFRADEX IF YOU ARE PREGNANT OR INTEND TO BECOME PREGNANT. Like most aminoglycosides, Sofradex is not recommended for use during pregnancy. DO NOT USE SOFRADEX AFTER THE EXPIRY DATE (EXP) PRINTED ON THE PACK. If you use this medicine after the expiry date has passed, it may not work as well. DO NOT USE SOFRADEX IF THE PACKAGING IS TORN OR SHOWS SIGNS OF TAMPERING, OR IF IT DOESN Leia o documento completo
sof-ds-ccdsv2-dsv4-16aug22 Page 1 of 7 NEW ZEALAND DATA SHEET 1 PRODUCT NAME Sofradex, Ear/Eye Drops 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each mL of drops contains framycetin sulfate 5mg, gramicidin 0.05mg and dexamethasone 0.5mg. For full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Ear/Eye Drops Sterile, clear, colourless drops 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS IN THE EYE: For the short term treatment of steroid responsive conditions of the eye when prophylactic antibiotic treatment is also required, after excluding the presence of fungal or viral disease. IN THE EAR: Otitis externa. 4.2 DOSE AND METHOD OF ADMINISTRATION DOSAGE _ADULTS, ELDERLY AND CHILDREN _ IN THE EYE: 1 or 2 drops applied to each affected eye up to six times daily or more frequently if required. IN THE EAR: 2 or 3 drops instilled into the ear three or four times daily. (No dosage adjustment is necessary for the Elderly and Children). sof-ds-ccdsv2-dsv4-16aug22 Page 2 of 7 ADMINISTRATION Auricular and Ocular use. 4.3 CONTRAINDICATIONS Hypersensitivity to the active substance (see Section 2) or to any of the excipients listed in Section 6.1 Acute purulent, untreated infections of the eye, which, like other diseases caused by micro-organisms, may be masked or enhanced by the presence of the steroid Tuberculosis and fungal diseases of the eye Glaucoma If herpetic keratitis (eg dendritic ulcer) is considered a possibility Herpes simplex and other viral diseases of the cornea and conjunctiva, use of topical steroids in this condition can lead to extension of the ulcer and marked visual deterioration Trachoma Eardrum perforation because of the risk of ototoxicity Viral and fungal infections of the ear Acute purulent, untreated infections of the ear 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Although it is unlikely that infants will be treated with Sofradex for prolonged periods, there is a risk of adrenal suppression, even without occlusive dressings, after prolonged tre Leia o documento completo