국가: 오스트레일리아
언어: 영어
출처: Department of Health (Therapeutic Goods Administration)
tobramycin, Quantity: 3 mg/mL
Novartis Pharmaceuticals Australia Pty Ltd
Eye Drops, solution
Excipient Ingredients: sodium chloride; boric acid; benzalkonium chloride; sodium hydroxide; tyloxapol; hydrochloric acid; sodium sulfate; purified water
Ophthalmic
5mL
Medicine Registered
(S4) Prescription Only Medicine
TOBREX(tobramycin) Eye drops 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.
Visual Identification: Clear, colourless to pale yellow or brown solution.; Container Type: Bottle; Container Material: LDPE; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius
Registered
1991-10-15
TOBREX ® _EYE DROPS AND EYE OINTMENT 0.3%_ _Tobramycin_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET Please read this leaflet carefully before you use Tobrex Eye Drops and Tobrex Eye Ointment. This leaflet answers some common questions about Tobrex Eye Drops and Ointment. It does not contain all of 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.NOVARTIS.COM.AU 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 expected benefits of you using Tobrex against the risks this medicine could 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 THE 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_ DO NOT USE TOBREX IN CHILDREN UNDER 12 MONTHS OF AGE. The safety and effectiveness of Tobrex in children under the age of 12 months has not been established. B 전체 문서 읽기
1 AUSTRALIAN PRODUCT INFORMATION – TOBREX (TOBRAMYCIN) EYE DROPS TOBREX (TOBRAMYCIN) EYE OINTMENT 1 NAME OF THE MEDICINE Tobramycin 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each mL of TOBREX Eye Drops contains tobramycin 0.3% (3mg). Each gram of TOBREX Eye Ointment contains tobramycin 0.3% (3mg). May contain traces of potential allergens such as soya beans from the manufacturing process. For the full list of excipients, see Section 6.1 List of excipients. 3 PHARMACEUTICAL FORM TOBREX (tobramycin) 0.3% Eye Drops and TOBREX (tobramycin) 0.3% Eye Ointment (TOBREX) are sterile topical antibiotic formulations prepared specifically for topical therapy of bacterial eye infections. TOBREX Eye Drops has a pH range between 7.0 and 8.0. 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC INDICATIONS TOBREX (tobramycin) Eye Drops and TOBREX (tobramycin) 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 D OSE AND METHOD OF ADMINISTRATION DOSAGE 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. 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 7-10 days. 2 4.3 C ONTRAINDICATIONS TOBREX (tobramycin) 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. 4.4 S PECIAL WARNINGS AND PRECAUTIONS FOR USE FOR TOPICAL OPHTHALMIC USE ONLY. NOT FOR INJECTION INTO THE EYE. HYPERSENSITIVITY Sensitivity to topically adm 전체 문서 읽기