Država: Irska
Jezik: angleščina
Source: HPRA (Health Products Regulatory Authority)
DEXAMETHASONE, POLYMYXIN B SULFATE, NEOMYCIN SULFATE
Novartis Pharmaceuticals UK Ltd
S01CA01
DEXAMETHASONE, POLYMYXIN B SULFATE, NEOMYCIN SULFATE
%w/v
Eye Drops Suspension
Product subject to prescription which may not be renewed (A)
Corticosteroids and antiinfectives in combination
Authorised
2017-05-05
1 PACKAGE LEAFLET - INFORMATION FOR THE USER MAXITROL ® 0.1% W/V, 6000 IU/ML, 3500 IU/ML EYE DROPS, SUSPENSION DEXAMETHASONE, POLYMYXIN B SULPHATE, NEOMYCIN SULPHATE READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE. • KEEP THIS LEAFLET. You may need to read it again. • IF YOU HAVE ANY FURTHER QUESTIONS, ask your doctor or your pharmacist. • This medicine has been prescribed for you. DO NOT PASS IT ON TO OTHERS. It may harm them, even if their symptoms are the same as yours. • IF ANY OF THE SIDE EFFECTS GET SERIOUS, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. IN THIS LEAFLET 1. WHAT MAXITROL IS AND WHAT IT IS USED FOR 2. BEFORE YOU USE MAXITROL 3. HOW TO USE MAXITROL 4. POSSIBLE SIDE EFFECTS 5. HOW TO STORE MAXITROL 6. FURTHER INFORMATION 1. WHAT MAXITROL IS AND WHAT IT IS USED FOR MAXITROL contains a steroid, dexamethasone and two antibiotics, neomycin sulphate and polymyxin B sulphate. IT IS USED FOR THE SHORT TERM TREATMENT of inflammation of the eye, where administration of an antibiotic is also required to prevent an eye infection. 2. BEFORE YOU USE MAXITROL DO NOT USE MAXITROL... • If you have ANY TYPE OF INFECTION of the eye that is not being treated including viral, fungal or untreated parasitic eye infections or Tuberculosis of the eye. Use of steroids may make infections worse. • If you are ALLERGIC to dexamethasone, polymyxin B, neomycin or to any of the other ingredients listed in section 6. Ask your doctor for advice. TAKE SPECIAL CARE... • Only use MAXITROL in your eye(s). • Consult your doctor or pharmacist before using this medicine if you have a disorder causing a THINNING OF THE EYE TISSUES . • If you experience ALLERGIC REACTIONS with MAXITROL, discontinue use and consult your doctor. Allergic reactions may vary from localized itching or skin redness to severe allergic reactions (anaphylactic reaction) or serious skin reactions. These allergic reactions may occur with other topical or systemic anti Preberite celoten dokument
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Maxitrol 0.1% w/v, 6000 IU/ml, 3500 IU/ml eye drops, suspension. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml suspension contains 1 mg Dexamethasone, 6000 IU Polymyxin B Sulphate, 3500 IU Neomycin Sulphate (as base) Excipients: 1ml suspension contains 0.04 mg Benzalkonium Chloride For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Eye drops, suspension White to pale yellow opaque suspension. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Maxitrol Eye Drops is indicated 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 and viral disease. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Children and Adults (including the Elderly) Apply one or two drops to each affected eye up to six times daily or, more frequently if required. Heptic and renal impairment Maxitrol Eye Drops has not been studied in these subject populations. Method of administration For ocular use only. Not for injection or ingestion. Shake the bottle well before use. 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. 4.3 CONTRAINDICATIONS Hypersensitivity to the active substances or to any of the excipients. Herpes simplex keratitis. Vaccinia, varicella, and other viral infection of cornea or conjunctiva. Fungal diseases of ocular structures or untreated parasitic eye infections. Mycobacterial ocular infections. H E A L T H P R O D U C T S R E G U L A T O R Y A U T Preberite celoten dokument