Страна: Европейский союз
Язык: английский
Источник: EMA (European Medicines Agency)
human fibrinogen, human thrombin
Mallinckrodt Pharmaceuticals Ireland Limited
B02BC30
human fibrinogen, human thrombin
Antihemorrhagics
Hemostasis, Surgical
Supportive treatment where standard surgical techniques are insufficient for improvement of haemostasis.Raplixa must be used in combination with an approved gelatin sponge.Raplixa is indicated in adults over 18 years of age.
Revision: 6
Withdrawn
2015-03-19
22 B. PACKAGE LEAFLET Medicinal product no longer authorised 23 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT RAPLIXA SEALANT POWDER 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 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 get any of the side effects talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Raplixa is and what it is used for 2. What you need to know before you are treated with Raplixa 3. How to use Raplixa 4. Possible side effects 5. How to store Raplixa 6. Contents of the pack and other information 1. WHAT RAPLIXA IS AND WHAT IT IS USED FOR The active ingredient fibrinogen is a concentrate of clottable protein; the other active ingredient thrombin is an enzyme that causes clottable protein to coalesce to form a plug. Raplixa is applied during surgical operations, to reduce bleeding and oozing during and after the operation in adults. In combination with a gelatin sponge, Raplixa is applied or sprayed onto cut tissue where it forms a layer that helps to stop bleeding. 2. WHAT YOU NEED TO KNOW BEFORE YOU ARE TREATED WITH RAPLIXA DO NOT USE RAPLIXA: - if you are allergic to human fibrinogen, human thrombin or any of the other ingredients of this medicine (listed in section 6) - directly inside a blood vessel - in endoscopic procedures (procedures that use an endoscope for viewing internal organs) or keyhole surgery - as a glue for the fixation of patches - as a glue for intestines (gastrointestinal anastomoses) - on severe arterial bleeds Medicinal product no longer authorised 24 WARNINGS AND PRECAUTI Прочитать полный документ
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 Raplixa sealant powder 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each gram of powder contains 79 mg human fibrinogen and 726 IU human thrombin. Raplixa is supplied in three different presentations 0.5 grams (39.5 mg human fibrinogen and 363 IU human thrombin), 1 gram (79 mg human fibrinogen and 726 IU human thrombin) and 2 grams (158 mg human fibrinogen and 1452 IU human thrombin). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Sealant powder Dry white powder. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Supportive treatment where standard surgical techniques are insufficient for improvement of haemostasis. Raplixa must be used in combination with an approved gelatin sponge (see section 5.1). Raplixa is indicated in adults over 18 years of age. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION The use of Raplixa is restricted to experienced surgeons. Gelatin sponges must be used in combination with Raplixa. Gelatin sponges are CE marked and separately supplied and packed (see instructions for use for the specific gelatin sponge selected for use). Posology The amount of Raplixa to be applied and the frequency of application should always be oriented towards the underlying clinical needs for the patient. The dose to be applied is governed by variables including, but not limited to, the type of surgery, the size of the bleeding surface area, the severity of bleeding, the mode of application selected by the surgeon, and the number of applications. Application of the product must be individualised by the treating surgeon. In clinical trials a thin layer of Raplixa produced doses that typically ranged from 0.3 to 2 g. For som Прочитать полный документ