Land: Storbritannia
Språk: engelsk
Kilde: MHRA (Medicines & Healthcare Products Regulatory Agency)
Hydrocortisone; Neomycin sulfate; Polymyxin B sulfate
Phoenix Labs Ltd
S02CA03
Hydrocortisone; Neomycin sulfate; Polymyxin B sulfate
10mg/1ml ; 3400unit/1ml ; 10000unit/1ml
Ear drops
Auricular
No Controlled Drug Status
Never Valid To Prescribe As A VMP
BNF: 12010100; GTIN: 5010706002401 5010706002418
31040600 Measurement Bar (mm) February 2017 Measurement Bar (mm) Les hele dokumentet
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Otosporin Ear Drops. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Polymyxin B Sulphate 10,000 units per ml Neomycin Sulphate 3,400 units per ml Hydrocortisone 1.0% w/v Excipient(s) with known effect: Also contains cetostearyl alcohol and methyl hydroxybenzoate E218 For a full list of excipients, see Section 6.1. 3 PHARMACEUTICAL FORM Liquid for topical application to humans. 4 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. _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 Otosporin ear drops are for topical administration into the ear only. 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 antibiotics. Children Otosporin Ear Drops are suitable for use in children ( 3 years and over) at the same dose as adults. A possibility of increased absorption exists in very young children, thus Otosporin Ear Dro Les hele dokumentet