Kraj: Unia Europejska
Język: angielski
Źródło: EMA (European Medicines Agency)
becaplermin
Janssen-Cilag International NV
D03AX06
becaplermin
Preparations for treatment of wounds and ulcers
Wound Healing; Skin Ulcer
Regranex is indicated, in association with other good wound care measures, to promote granulation and thereby the healing of full-thickness, neuropathic, chronic, diabetic ulcers less than or equal to 5 cm2.
Revision: 18
Withdrawn
1999-03-29
B. PACKAGE LEAFLET 13 Medicinal product no longer authorised PACKAGE LEAFLET: INFORMATION FOR THE USER REGRANEX 0.01% GEL. Becaplermin 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 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 REGRANEX is and what it is used for 2. Before you use REGRANEX 3. How to use REGRANEX 4. Possible side effects 5. How to store REGRANEX 6. Further information 1. WHAT REGRANEX IS AND WHAT IT IS USED FOR The name of your medicine is REGRANEX. It contains a substance called becaplermin. Becaplermin is a human recombinant Platelet Derived Growth Factor (rhPDGF). REGRANEX is used to help the growth of normal tissue in order to heal skin ulcers. It is used with other good wound care measures to help with the healing of the ulcers. Good wound care measures include: • Your doctor or healthcare professional removing dead skin/debris from the wound whenever necessary • Keeping weight off your feet, perhaps by wearing special orthopaedic shoes or by other methods • Your doctor or healthcare professional treating any infection of the wound - treatment with REGRANEX should be stopped if the wound becomes infected • Continuing to visit your doctor or healthcare professional and following your treatment plan REGRANEX is used for skin ulcers that: • Are not more than 5 square centimetres (see diagram opposite) and have a good blood supply • Are due to complications of diabetes. _Insert diagram of size (circle measuring 2.524 cm in diameter) _ By using REGRANEX, it is more likely that your skin ulcers will heal quickly and completely. 2. BEFORE YOU USE REGRANEX DO NOT USE REGRANEX: Przeczytaj cały dokument
ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 1 Medicinal product no longer authorised 1. NAME OF THE MEDICINAL PRODUCT REGRANEX 0.01% gel 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each gram of gel contains 100 μ g of becaplermin*. * Recombinant human Platelet Derived Growth Factor-BB (rhPDGF-BB) produced in _Saccharomyces cerevisiae _ by recombinant DNA technology. Excipients: Each gram contains E218 (methyl parahydroxybenzoate) 1.56 mg and E216 (propyl parahydroxybenzoate) 0.17 mg, see section 4.4. For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Gel. REGRANEX is a clear colourless to straw-coloured gel. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS REGRANEX is indicated, in association with other good wound care measures, to promote granulation and thereby the healing of full-thickness, neuropathic, chronic, diabetic ulcers less than or equal to 5 cm 2 . 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Treatment with REGRANEX should be initiated and monitored by physicians (specialists or non- specialists) who are experienced in the management of diabetic wounds. REGRANEX should always be used in conjunction with good wound care consisting of initial debridement (to remove all the necrotic and/or infected tissue), additional debridement as necessary and a non-weight-bearing regimen to alleviate pressure on the ulcer. REGRANEX should be applied as a continuous thin layer to the entire ulcerated area(s) once daily using a clean application aid. The site(s) of application should then be covered by a moist saline gauze dressing that maintains a moist wound-healing environment. REGRANEX should not be used in conjunction with occlusive dressings. - A tube of REGRANEX should be used on a single patient only. - Care should be taken during use to avoid microbial contamination and spoilage. - Hands should be washed thoroughly before applying REGRANEX. - The tip of the tube should not come into contact with the wound or any other surface. - The use of a clean application aid is recommended and contac Przeczytaj cały dokument