Ország: Írország
Nyelv: angol
Forrás: HPRA (Health Products Regulatory Authority)
Clostridiopeptidase a; Protease
T.J. Smith & Nephew
D03BA; D03BA52
Clostridiopeptidase a; Protease
1.2 unit(s)/gram
Ointment
Product subject to prescription which may be renewed (B)
Proteolytic enzymes; collagenase, combinations
Marketed
1990-09-03
PACKAGE LEALFET: INFORMATION FOR THE USER IRUXOL® MONO 1.2 U/G OINTMENT CLOSTRIDIOPEPTIDASE A READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. • Keep this leaflet. You may need to read it again. • If you have any further questions, please ask your doctor or pharmacist. • This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. • If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. WHAT IS IN THIS LEAFLET 1. What IRUXOL® Mono is and what it is used for 2. Before you use IRUXOL® Mono 3. How to use IRUXOL® Mono 4. Possible side effects 5. How to store IRUXOL® Mono 6. Contents of the pack and other information 1. WHAT IRUXOL® MONO IS AND WHAT IT IS USED FOR IRUXOL® Mono ointment contains clostridiopeptidase (a collagenase enzyme) and protease enzymes. Each gram of ointment contains not less than 1.2 units of Clostridiopeptidase A and not less than 0.24 units of associated proteases as active ingredients. These enzymes can be used to remove dead tissue (debride) from wounds such as leg ulcers, diabetic ulcers and pressure sores. By removing the dead tissue, IRUXOL® Mono ointment cleanses the wound and speeds up wound healing. 2. BEFORE YOU USE IRUXOL® MONO DO NOT USE IRUXOL® MONO OINTMENT if you are allergic to protease enzymes or any of the other ingredients of this medicine (listed in section 6). TAKE SPECIAL CARE WITH IRUXOL® MONO OINTMENT IF: • you are diabetic and have been told that the wound contains dry gangrenous material. IF YOU ARE USING OTHER MEDICINES PLEASE SEE FOLLOWING SECTION. USING OTHER MEDICINES IRUXOL® Mono ointment should NOT be used if you are applying other products to the wound that may interfere with the medicine such as: • antiseptics • antibiotics (tyrothricin, gramicidin and tetracyclines) • heavy metals • detergents • soaps Olvassa el a teljes dokumentumot
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Iruxol Mono 1.2U/g Ointment 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each gram of ointment contains not less than 1.2 units of clostridiopeptidase A and not less than 0.24 units of associated proteases. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Ointment. A brown, lipophilic ointment with a faint characteristic odour. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Iruxol Mono is indicated for the enzymatic debridement of necrotising wounds, including leg and decubital ulcers. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION For topical administration. A layer of approximately 2 mm of ointment should be applied to the dressing or directly to the slightly moistened area to be treated once daily. Close contact to the wound surface should be assured. Occasionally, twice daily use may be required. It is unnecessary to apply too great an amount of the product to the wound. With this, the cleaning process is not improved. In general, it will suffice to change the dressing once daily. An increase of activity may possibly be obtained by applying the ointment twice daily. The treatment of varicose ulcers with Iruxol Mono ointment will be usefully supplemented by a pressure bandage and in arterial circulatory disorders, ulcers of diabetic or neurologic etiology, by appropriate drug treatment. To ensure successful enzymatic wound treatment with Iruxol Mono ointment, sufficient moisture must be present in the wound area during therapy. In dry wounds, the wound base must therefore be moistened with physiological saline (0.9% NaCl) or other solutions which are well tolerated by the tissue (e.g. glucose). Dry and hard crusts should first be softened by applying a moist dressing. Treatment with Iruxol Mono should be discontinued when the whole surface of the wound is clean. Whenever infection is present, an appropriate antibiotic treatment should be considered. Chloramphenicol, neomycin, framycetin, bacitracin, gentamicin, polymyxin B and Olvassa el a teljes dokumentumot