Страна: Европейски съюз
Език: английски
Източник: EMA (European Medicines Agency)
Betulae cortex
Amryt AG
D03AX13
birch bark extract
Preparations for treatment of wounds and ulcers
Wounds and Injuries; Wound Healing
Treatment of partial thickness wounds in adults. See sections 4.4 and 5.1 in Product Information with respect to type of wounds studied.,
Revision: 7
Withdrawn
2016-01-14
B. PACKAGE LEAFLET 15 Medicinal product no longer authorised PACKAGE LEAFLET: INFORMATION FOR THE PATIENT EPISALVAN GEL birch bark extract 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, ask your doctor or nurse. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Episalvan is and what it is used for 2. What you need to know before you use Episalvan 3. How to use Episalvan 4. Possible side effects 5. How to store Episalvan 6. Contents of the pack and other information 1. WHAT EPISALVAN IS AND WHAT IT IS USED FOR Episalvan gel is a herbal medicinal product which contains dry extract from birch bark. It is used in adults for the treatment of skin wounds, resulting for example from grade 2a burn wounds or from surgical skin graft transplantation. There is no experience of the use of Episalvan for the treatment of chronic wounds, e.g. diabetic foot ulcers or venous leg ulcers. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE EPISALVAN _ _ DO NOT USE EPISALVAN - if you are allergic to birch bark or any of the other ingredients of this medicine (listed in section 6). WARNINGS AND PRECAUTIONS Talk to your doctor or nurse before using Episalvan. Episalvan does not contain birch pollen, so it may be used by people with birch pollen allergy. Wound infection is a serious complication that can occur during the healing process. Possible signs of a wound infection are that the wound begins to drain yellow or greenish fluid (pus), or that the skin around the wound becomes red, warm, swollen, or increasingly painful. CHILDREN AND ADOLESCENTS Do not give this medicine to children and adolescents under 18 yea Прочетете целия документ
ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 1 Medicinal product no longer authorised 1. NAME OF THE MEDICINAL PRODUCT Episalvan gel 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 1 g gel contains: 100 mg extract (as dry extract, refined) from birch bark from _Betula pendula_ Roth, _Betula pubescens _ Ehrh. as well as hybrids of both species (equivalent to 0.5-1.0 g birch bark), corresponding to 72-88 mg betulin. Extraction solvent: n-Heptane For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Gel. Colourless to slightly yellowish, opalescent. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of partial thickness wounds in adults. See section 4.4 and 5.1 with respect to type of wounds studied. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The gel should be applied to the wound surface at a thickness of approximately 1 mm and covered by sterile wound dressing. The gel should be re-applied at each wound dressing change, until the wound is healed, for up to 4 weeks (see section 4.4 “wound size” and “duration of use”). Special populations _Renal or hepatic impairment _ No formal studies have been conducted with Episalvan in patients with renal or hepatic impairment. No dose adjustment or special considerations are anticipated for patients with renal or hepatic impairment (see section 5.2). _Elderly _ No dose adjustment is required. _Paediatric population _ The safety and efficacy of Episalvan in children and adolescents under 18 years have not yet been established. No data are available. Method of administration For cutaneous application. Fresh wounds should achieve haemostasis prior to application of Episalvan. If necessary, wounds (accidental wounds) should be cleaned according to standard procedure, using e.g. wound antiseptic solution, prior to application of Episalvan. 2 Medicinal product no longer authorised Episalvan is for single use only. 4.3 CONTRAINDICATIONS Hypersensitivity to the active substance or to the excipient listed in section 6.1. 4.4 SPECIAL WARNINGS AND Прочетете целия документ