Land: Nýja-Sjáland
Tungumál: enska
Heimild: Medsafe (Medicines Safety Authority)
Tobramycin 3 mg/mL
Novartis New Zealand Ltd
Tobramycin 3 mg/mL
0.3 %
Eye drops, solution
Active: Tobramycin 3 mg/mL Excipient: Benzalkonium chloride Boric acid Purified water Sodium chloride Sodium hydroxide Sodium sulfate Sulfuric acid Tyloxapol
Bottle, plastic, Opaque LDPE with LDPE plug and polypropylene cap, 5 mL
Prescription
Prescription
Teva Pharmaceutical Works Private Limited Company
Tobrex Eye Drops and Eye Ointment are topical antibiotics indicated in the treatment of external infections of the eye and its adnexa caused by susceptible bacteria. Appropriate monitoring of bacterial response to topical antibiotic therapy should accompany the use of Tobrex.
Package - Contents - Shelf Life: Bottle, plastic, Opaque LDPE with LDPE plug and polypropylene cap - 5 mL - 36 months from date of manufacture stored at or below 25°C 4 weeks opened stored at or below 25°C
1982-11-04
Internal document code 1 Tox041121cNZ_V2 based on DS tox041121iNZ TOBREX TM EYE DROPS AND EYE OINTMENT 0.3% _Tobramycin _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET READ THIS LEAFLET CAREFULLY BEFORE YOU START TO USE TOBREX EYE DROPS AND EYE OINTMENT. This leaflet answers some common questions about Tobrex. 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 Tobrex against the expected benefits it will have for you. The information in this leaflet applies to Tobrex only. This information does not apply to similar products, even if they contain the same ingredients. 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 TOBREX IS USED FOR Tobrex is used to treat bacterial infections of the external part of the eye. Tobrex contains tobramycin which is an “aminoglycoside” antibiotic. Before prescribing Tobrex your doctor will have examined your eye(s) and decided that Tobrex is the right medicine for you. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS BEEN PRESCRIBED FOR YOU. Your doctor may have prescribed Tobrex for another reason. This medicine is only available with a doctor’s prescription. There is no evidence that Tobrex is addictive. _USE IN CHILDREN _ The safety and effectiveness of Tobrex in children under the age of 12 months has not been established. BEFORE YOU USE TOBREX _WH Lestu allt skjalið
Internal document code 1 tox041121iNZ based on CDS dated 22 March 2019 NEW ZEALAND DATA SHEET 1. PRODUCT NAME TOBREX TM Eye Drops 0.3% TOBREX TM Eye Ointment 0.3 % 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each mL of Tobrex Eye Drops contains the active ingredient tobramycin 3 mg in 1 mL. Excipient with known effect Benzalkonium chloride 0.1 mg in 1 mL (0.01%) as a preservative in the eye drops. Each g of Tobrex Eye Ointment contains the active ingredient tobramycin 3 mg in 1 g. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Eye drops, solution. Eye ointment. 4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS Tobrex Eye Drops and Eye Ointment are topical antibiotics indicated in the treatment of external infections of the eye and its adnexa caused by susceptible bacteria. Appropriate monitoring of bacterial response to topical antibiotic therapy should accompany the use of Tobrex. 4.2. DOSE AND METHOD OF ADMINISTRATION TOBREX EYE DROPS In mild to moderate disease, instill one or two drops into the affected eye(s) every four hours. In severe infections, instill two drops into the eye(s) hourly until improvement. The maximum dose is 14 drops/day in children 1 to <2 years and 46 drops/day in children 2 to <12 years of age. TOBREX EYE OINTMENT In mild to moderate disease, apply a 1 - 1.5 cm ribbon into the affected eye(s) two or three times per day. In severe infections, apply a 1 - 1.5 cm ribbon every three to four hours until improvement. Treatment with Tobrex should be reduced prior to discontinuation. The usual duration of treatment is 7 to 10 days. 4.3. CONTRAINDICATIONS Tobrex Eye Drops and Eye Ointment are contraindicated in patients with known hypersensitivity to tobramycin or to other aminoglycosides or any other ingredients in this product listed under Section 6.1. 4.4. SPECIAL WARNINGS AND PRECAUTIONS FOR USE FOR TOPICAL OPHTHALMIC USE ONLY. NOT FOR INJECTION INTO THE EYE. Internal document code 2 tox041121iNZ based on CDS dated 22 March 2019 HYPERSENSITIVITY Sensitivity to to Lestu allt skjalið