Држава: Нови Зеланд
Језик: Енглески
Извор: Medsafe (Medicines Safety Authority)
Dexamethasone 0.1%{relative} (+2% Manufacturers overage.); ; ; Tobramycin 0.3%{relative} (+7% Manufacturers overage.);
Novartis New Zealand Ltd
Dexamethasone 0.1% w/w (+2% Manufacturers overage.)
Eye ointment
Active: Dexamethasone 0.1%{relative} (+2% Manufacturers overage.) Tobramycin 0.3%{relative} (+7% Manufacturers overage.) Excipient: Chlorobutanol Liquid paraffin White soft paraffin
Tube, 1x3.5g, 3.5 g
Prescription
Prescription
Sanofi Chimie
Package - Contents - Shelf Life: Tube, - 3.5 g - 24 months from date of manufacture stored at or below 25°C
1992-06-29
Internal document code Tobd200519c based on DS Tobd200519iNZ 1 TOBRADEX TM EYE DROPS _ _ _Tobramycin and Dexamethasone _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET READ THIS LEAFLET CAREFULLY BEFORE YOU START TO USE TOBRADEX EYE DROPS. This leaflet answers some common questions about Tobradex Eye Drops. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. The information in this leaflet was last updated on the date listed on the final page. More recent information on the medicine may be available. YOU SHOULD ENSURE THAT YOU SPEAK TO YOUR PHARMACIST OR DOCTOR TO OBTAIN THE MOST UP TO DATE INFORMATION ON THE MEDICINE. YOU CAN ALSO DOWNLOAD THE MOST UP TO DATE LEAFLET FROM www.medsafe.govt.nz. The updates may contain important information about the medicine and its use of which you should be aware. All medicines have risks and benefits. Your doctor has weighed the risks of you using Tobradex 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 YOUR MEDICINE. You may need to read it again. WHAT TOBRADEX IS USED FOR Tobradex Eye Drops contain tobramycin and dexamethasone. Tobramycin is an aminoglycoside antibiotic. Dexamethasone is a type of cortisone and belongs to the group of medicines called corticosteroids. Tobradex Eye Drops are used to treat inflammation, corneal injury and bacterial infections in the external part of the eye. Before prescribing Tobradex Eye Drops for you, your doctor will have examined your eye(s) and decided that Tobradex Eye Drops is the right medicine for you. Your doctor may have prescribed Tobradex for another purpose. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY TOBRADEX HAS BEEN PRESCRIBED_ _FOR YOU. There is no evidence that Tobradex Eye Drops are addictive. This medicine is available only with a doctor’s prescription. _USE IN CHILDREN _ Tobradex is not for use in children. The safety and effect Прочитајте комплетан документ
Internal Document code 1 tobd100820iNZ based on CDS dated 22 March 2019 NEW ZEALAND DATA SHEET 1. PRODUCT NAME TOBRADEX™ (tobramycin 0.3% and dexamethasone 0.1%) Ophthalmic Suspension TOBRADEX™ (tobramycin 0.3% and dexamethasone 0.1%) Ophthalmic Ointment. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION _Tobradex Ophthalmic Suspension _ Each mL of the drops contains tobramycin 3 mg and dexamethasone 1 mg. _Tobradex Eye Ointment _ Each gram of the ointment contains tobramycin 3 mg and dexamethasone 1mg. Excipient with known effect _Tobradex Ophthalmic Suspension _ Benzalkonium chloride 0.01% as a preservative. _Tobradex Eye Ointment _ Chlorobutanol 0.5% as a preservative. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM _Tobradex Eye Drops _ Eye drops, suspension. _Tobradex Eye Ointment _ Ointment. 4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS Tobradex Ophthalmic Suspension and Ointment are indicated for steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where superficial bacterial ocular infection or a risk of bacterial ocular infection exists. Ocular steroids are indicated in inflammatory conditions of the palpebral and bulbar conjunctiva, cornea and anterior segment of the globe where the inherent risk of steroid use in certain infective conjunctivitides is accepted to obtain a diminution in oedema and inflammation. They are also indicated in chronic anterior uveitis and corneal injury from chemical, radiation or thermal burns or penetration of foreign bodies. The use of a combination medicine with an anti-infective component is indicated where the risk of superficial ocular infection is high or where there is an expectation that potentially dangerous numbers of bacteria will be present in the eye. 4.2. DOSE AND METHOD OF ADMINISTRATION Ophthalmic Suspension Shake well before use. One or two drops instilled into the conjunctival sac(s) every four to six hours. During the initial 24 to 48 hours, the dosage may be increased to one or two dro Прочитајте комплетан документ