Država: Europska Unija
Jezik: engleski
Izvor: EMA (European Medicines Agency)
human fibrinogen, human thrombin
Omrix Biopharmaceuticals N. V.
B02BC30
human fibrinogen, human thrombin
Local hemostatics
Hemostasis
Supportive treatment in adult surgery where standard surgical techniques are insufficient (see section 5.1):- for improvement of haemostasis.
Revision: 4
Withdrawn
2013-09-25
21 B. PACKAGE LEAFLET Medicinal product no longer authorised 22 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT EVARREST SEALANT MATRIX Human Fibrinogen / Human Thrombin This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects. READ ALL OF THIS LEAFLET CAREFULLY BEFORE THIS MEDICINE IS USED TO TREAT YOU, 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 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 EVARREST is and what it is used for 2. What you need to know before you are treated with EVARREST 3. How EVARREST is used 4. Possible side effects 5. How to store EVARREST 6. Contents of the pack and other information 1. WHAT EVARREST IS AND WHAT IT IS USED FOR EVARREST is a combination product made from an absorbable material (Matrix) coated with human fibrinogen and human thrombin. Fibrinogen is a protein extracted from the blood that forms a fibrin clot when acted upon by the enzyme thrombin. When the dry powder coating of EVARREST is wetted, the thrombin acts on the fibrinogen to rapidly form a clot. The fibrin clot becomes embedded in the Matrix which enables EVARREST to stick firmly to the surrounding tissue. EVARREST is applied during surgical operations in adult subjects, to stop bleeding and oozing during the operation. It is applied directly onto tissue where it sticks firmly and stops bleeding. It is left in place after the operation and is absorbed by the body. 2. WHAT YOU NEED TO KNOW BEFORE YOU ARE TREATED WITH EVARREST: YOUR SURGEON MUST NOT TREAT YOU WITH EVARREST IN THE FOLLOWING CIRCUMSTANCES: EVARREST must not be applied inside blood vessels. You must not be treated with EVARREST if you are allergic to human fibr Pročitajte cijeli dokument
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS Medicinal product no longer authorised 2 This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 for how to report adverse reactions. 1. NAME OF THE MEDICINAL PRODUCT EVARREST Sealant Matrix 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Component 1: Human Fibrinogen 8.1 mg/cm 2 Component 2 Human Thrombin 40 IU/cm 2 Excipient(s) with known effect: Contains up to 3.0 mmol (68.8 mg) sodium per sealant matrix. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Sealant Matrix EVARREST is a white-to-yellow bio-absorbable combination product made from a flexible composite Matrix, coated with Human Fibrinogen and Human Thrombin. The active side of the sealant matrix is powdery, and the non-active side has an embossed wave pattern. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Supportive treatment in adult surgery where standard surgical techniques are insufficient (see section 5.1): - for improvement of haemostasis. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION The use of EVARREST is restricted to experienced surgeons. Posology The amount of EVARREST to be applied and the frequency of application should always be oriented towards the underlying clinical needs of the patient. The dose to be applied is governed by variables including, but not limited to, the type of surgical intervention, the size of the area and the mode of intended application, and the number of applications. The quantity of EVARREST to be applied depends upon the area and location of the bleeding area to be treated. EVARREST should be applied so it extends approximately 1 to 2 cm beyond the margins of the target bleeding area. It can be cut to the size and shape required to fit the size of the bleeding area. Medicinal product no longer authorised 3 Bleeding areas larger than those which can be covered by a single unit of EVARRES Pročitajte cijeli dokument