Land: Europäische Union
Sprache: Englisch
Quelle: EMA (European Medicines Agency)
proteolytic enzymes enriched in bromelain
MediWound Germany GmbH
D03BA03
concentrate of proteolytic enzymes enriched in bromelain
Preparations for treatment of wounds and ulcers
Debridement
NexoBrid is indicated for removal of eschar in adults with deep partial- and full-thickness thermal burns.
Revision: 15
Authorised
2012-12-18
B. PACKAGE LEAFLET 36 PACKAGE LEAFLET: INFORMATION FOR THE USER _ _ NEXOBRID 2 G POWDER AND GEL FOR GEL concentrate of proteolytic enzymes enriched in bromelain 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. - If you or your child get any side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What NexoBrid is and what it is used for 2. What you need to know before NexoBrid is used 3. How NexoBrid is used 4. Possible side effects 5. How NexoBrid is stored 6. Contents of the pack and other information 1. WHAT NEXOBRID IS AND WHAT IT IS USED FOR WHAT NEXOBRID IS NexoBrid contains a mixture of enzymes called “concentrate of proteolytic enzymes enriched in bromelain”, which is produced from an extract from the stem of the pineapple plant. WHAT NEXOBRID IS USED FOR NexoBrid is used in adults, adolescents and children of all ages to remove burnt tissue from deep or partially deep burn wounds of the skin. Using NexoBrid may reduce the need for, or the extent of, surgical removal of burnt tissue and/or skin transplantation. 2. WHAT YOU NEED TO KNOW BEFORE NEXOBRID IS USED _ _ NEXOBRID MUST NOT BE USED: - if you or your child are allergic to bromelain - if you or your child are allergic to pineapples - if you or your child are allergic to papaya/papain - if you or your child are allergic to any of the other ingredients of the powder or gel (listed in section 6). WARNINGS AND PRECAUTIONS Talk to your doctor or nurse before NexoBrid is used if: - you or your child have a heart disease; - you or your child have diabetes; - you or your child have an active peptic ulcer in the stomach, - you or your child have a vascular disease (with vascular occlusion); - you or your child have enlarged veins in the area close to the burn; - you or your child have implant Lesen Sie das vollständige Dokument
ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS _ _ _ _ 1 1. NAME OF THE MEDICINAL PRODUCT NexoBrid 2 g powder and gel for gel NexoBrid 5 g powder and gel for gel 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One vial contains 2 g or 5g of concentrate of proteolytic enzymes enriched in bromelain, corresponding to 0.09 g/g concentrate of proteolytic enzymes enriched in bromelain after mixing (or 2 g/22 g gel or 5g/55g gel). The proteolytic enzymes are a mixture of enzymes from the stem of _Ananas comosus_ (pineapple plant). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Powder and gel for gel _ _ The powder is off-white to light tan. The gel is clear and colourless. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS NexoBrid is indicated in all age groups for removal of eschar in patients with deep partial- and full- thickness thermal burns _._ 4.2 POSOLOGY AND METHOD OF ADMINISTRATION This medicinal product should only be applied by trained healthcare professionals in specialist burn centres. Posology _Adults _ 2 g powder in 20 g gel is applied to 1 % Total Body Surface Area (TBSA) that corresponds to approximately 180 cm 2 of an adult with a layer thickness of 1.5 to 3 mm. 5g powder in 50 g gel is applied to 2.5 % TBSA that corresponds to approximately 450 cm 2 of an adult, with a gel layer thickness of 1.5 to 3 mm. NexoBrid should not be applied to more than 15% TBSA (see also section 4.4, Coagulopathy). _Paediatric population _ _Children and adolescents (from birth to 18 years of age) _ For paediatric patients aged 4-18 years old NexoBrid should not be applied to more than 15% TBSA. For paediatric patients aged 0-3 years old this medicine should not be applied to more than 10% TBSA. It should be left in contact with the burn wound for a duration of 4 hours. There is very limited information on the use of this medicinal product on areas where eschar remained after the first application. A second and subsequent application is not recommended. 2 Special populations _Renal impairment _ _ _ Ther Lesen Sie das vollständige Dokument