国: アイルランド
言語: 英語
ソース: HPRA (Health Products Regulatory Authority)
POLYMYXIN B SULFATE BACITRACIN ZINC
Pliva Pharma Limited
POLYMYXIN B SULFATE BACITRACIN ZINC
%v/v
Unknown
Product subject to prescription which may not be renewed (A)
Withdrawn
2013-04-26
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Polyfax Ophthalmic Ointment, 10,000 IU Polymyxin B Sulphate + 500 IU Bacitracin Zinc. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each gram of ointment contains: For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Eye ointment Off-white translucent ointment. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Polyfax Ophthalmic Ointment is indicated for the treatment of bacterial infections of the eye and its adnexa including conjunctivitis, keratitis, corneal ulceration and ulcerative blepharitis. Polyfax Ophthalmic Ointment may be applied both pre- and post-operatively to prevent ocular infection following surgical procedures, including the removal of foreign bodies from the eye. The use of Polyfax Ophthalmic Ointment does not exclude concomitant systemic therapy or other forms of local therapy where appropriate. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION A thin film of ointment should be applied, either directly to the affected area or inside the lower conjunctival sac twice or more times a day as directed by the physician. Treatment should be continued for at least 48 hours after the eye has apparently returned to normal. _Use in children: _Polyfax Ophthalmic Ointment may be used in children with dosages and administration regimens as for adults. _Use in the elderly: _No specific information is available regarding the use of this product in the elderly, however the maximum dosage should be reduced in cases where a decrease in renal function may exist _(see Special warnings and_ _precautions for use)_ 4.3 CONTRAINDICATIONS The use of Polyfax Ophthalmic Ointment is contra-indicated in patients who are hypersensitive to polymyxin B sulphate, bacitracin zinc, to cross-sensitising substances or to 完全なドキュメントを読む