Negara: Malta
Bahasa: Inggris
Sumber: Medicines Authority
POLYMYXIN B, SULFATE, HYDROCORTISONE, NEOMYCIN SULFATE
The Wellcome Foundation 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom
S02CA03
POLYMYXIN B SULFATE 10000 U/ml HYDROCORTISONE 1 % (W/V) NEOMYCIN SULFATE 3400 U/ml
EAR DROPS, SUSPENSION
POLYMYXIN B SULFATE 10000 U/ml HYDROCORTISONE 1 % (W/V) NEOMYCIN SULFATE 3400 U/ml
POM
OTOLOGICALS
Withdrawn
2006-01-09
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 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 gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. IN THIS LEAFLET: 1 What Otosporin is and what it is used for 2 Before you use Otosporin 3 How to use Otosporin 4 Possible side effects 5 How to store Otosporin 6 Further information 1 WHAT OTOSPORIN IS AND WHAT IT IS USED FOR The name of your ear drops is Otosporin. It is used to treat ear infections. • Otosporin contains three medicines called: polymyxin B sulphate, neomycin sulphate and hydrocortisone. • Polymyxin B sulphate and neomycin sulphate belong to a group of medicines called antibiotics. They kill the germs that can cause ear infections. • Hydrocortisone belongs to a group of medicines called steroids. It helps to reduce the swelling and irritation caused by the infection. 2 BEFORE YOU USE OTOSPORIN DO NOT USE OTOSPORIN: • if you are allergic (hypersensitive) to polymyxin B sulphate, neomycin sulphate, hydrocortisone or any of the other ingredients of Otosporin (See section 6: Further information) • if you are allergic (hypersensitive) to aminoglycoside antibiotics such as framycetin, kanamycin or gentamicin • if you have a perforated ear drum • if you have either a viral, fungal or tubercular (TB) infection • for a child under 3 years old. Do not use if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before using Otosporin. TAKE SPECIAL CARE WITH OTOSPORIN Check with your doctor or pharmacist before using your medicine if: • you have kidney problems. Your doctor may change how often you use Baca dokumen lengkapnya
Page 1 of 6 SUMMARY OF PRODUCT CHARACTERISTICS 1. TRADE NAME OF THE MEDICINAL PRODUCT Otosporin Ear Drops 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Polymyxin B Sulphate EP 10,000 units per ml Neomycin Sulphate EP 3,400 units per ml Hydrocortisone EP 1.0% w/v 3. PHARMACEUTICAL FORM Ear drops, suspension CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Otosporin Ear Drops are indicated for the treatment of otitis externa due to, or complicated by, bacterial infection. Route of Administration Topical In Vitro Activity Otosporin Ear Drops are active against a wide range of bacterial pathogens. The range of activity includes:- GRAM-POSITIVE ORGANISMS: _Staphylococcus Epidermis_ and _Staphylococcus Aureus:_ GRAM-NEGATIVE ORGANISMS: _Enterobacter Spp. _ _Escherichia Spp. _ _ _ _Haemophilus Spp. _ _ _ _Klebsiella Spp. _ _ _ _Proteus Spp. _ Page 2 of 6 _ _ _Pseudomonas Aeruginosa _ Otosporin Ear Drops are not expected to be active against streptococci, including _Streptococcus Pyogenes_ Hydrocortisone possesses anti-inflammatory, anti-allergic and antipruritic activity. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION ADULTS Following cleansing and drying of the external auditory meatus and canal as appropriate, three drops should be instilled into the affected ear three or four times daily. Alternatively, a gauze wick may be introduced into the external auditory canal and kept saturated with the solution; the wick may be left in place for 24 to 48 hours. Treatment should not be continued for more than 7 days without medical supervision. Soap should not be used for cleansing of the external auditory meatus and canal as it may inactivate the antibio Baca dokumen lengkapnya