Country: New Zealand
Language: English
Source: Medsafe (Medicines Safety Authority)
Dexamethasone 1 mg/g (3 % overage); ; Neomycin sulfate 3500 IU/g; Polymyxin B sulfate 6000 IU/g
Novartis New Zealand Ltd
Dexamethasone 1 mg/g (3 % overage)
Eye ointment
Active: Dexamethasone 1 mg/g (3 % overage) Neomycin sulfate 3500 IU/g Polymyxin B sulfate 6000 IU/g Excipient: Lanolin Methyl hydroxybenzoate Propyl hydroxybenzoate White soft paraffin
Tube, aluminium, 3.5 g
Prescription
Prescription
Sanofi Chimie
MAXITROL is indicated in ocular inflammation when concurrent use of an antimicrobial is judged necessary.
Package - Contents - Shelf Life: Tube, aluminium, - 3.5 g - 36 months from date of manufacture stored at or below 25°C. Do not refrigerate 4 weeks opened stored at or below 25°C. Do not refrigerate
1968-03-01
Internal document code maxto240221cNZ based on DS maxt240221iNZ 1 MAXITROL ™ EYE OINTMENT _ _ _Dexamethasone, Neomycin and Polymyxin B _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET READ THIS LEAFLET CAREFULLY BEFORE YOU START TO USE MAXITROL EYE OINTMENT. This leaflet answers some common questions about Maxitrol Eye Ointment. 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 Maxitrol against the expected benefits it will have for you. The information in this leaflet applies to Maxitrol Eye Ointment 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 MAXITROL EYE OINTMENT IS USED FOR Maxitrol Eye Ointment is a sterile eye ointment that contains the active ingredients dexamethasone, neomycin and polymyxin B. Both neomycin and polymyxin B are antibiotic agents. Dexamethasone is a type of cortisone and belongs to the group of medicines called corticosteroids. Maxitrol Eye Ointment is used to treat inflammation and bacterial infections in the external part of the eye. Before prescribing Maxitrol Eye Ointment, your doctor will have examined your eye(s) and decided that Maxitrol Eye Ointment is the right medicine for you. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS BEEN PRESCRIBED FOR YO Read the complete document
1 NEW ZEALAND DATA SHEET 1. PRODUCT NAME Maxitrol TM sterile ophthalmic suspension Maxitrol TM sterile ophthalmic ointment. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each mL of Maxitrol Ophthalmic Suspension contains dexamethasone 1 mg, neomycin sulfate 3,500 IU, polymixin B sulfate 6,000 IU. Each g of Maxitrol Ophthalmic Ointment contains Dexamethasone 1 mg, neomycin sulfate 3,500 IU, polymixin B sulfate 6,000 IU. Excipient with known effect Eye Drops: Benzalkonium chloride 0.004% as a preservative. Eye Ointment: Methyl hydroxybenzoate 0.05% as a preservative. Propyl hydroxybenzoate 0.01% as a preservative. For the full list of excipients, see Section 6.1. 3. PHARMACEUTICAL FORM Eye drops, suspension. Eye ointment. 4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS Maxitrol is indicated in ocular inflammation when concurrent use of an antimicrobial is judged necessary. 4.2. DOSE AND METHOD OF ADMINISTRATION Keep out of reach of children. If more than 1 topical ophthalmic medicinal product is being used, the medicines must be administered at least 5 minutes apart. Ointments should be administered last. Maxitrol Eye Drops One to two drops topically in the conjunctival sac(s). In severe disease, drops may be used hourly, being tapered to discontinuation as the inflammation subsides. In mild disease, drops may be used up to four to six times daily. Shake the bottle well before use. Remove the loose collar from the cap when the bottle is first opened. After cap is removed, if tamper evident snap collar is loose, remove before using product. In order to prevent contamination of the dropper tip and the suspension, caution should be exercised to ensure that the dropper tip does not touch the eyelids, the surroundings of the eye, or any other surfaces. Nasolacrimal occlusion or gently closing the eyelid after administration is recommended. This may reduce the systemic absorption of medicinal products administered via the ocular route and result in a decrease in systemic adverse reactions. 2 Maxitrol Eye Ointment Appl Read the complete document