Χώρα: Μάλτα
Γλώσσα: Αγγλικά
Πηγή: Medicines Authority
C, ESTERASE INHIBITOR, HUMAN
CSL Behring GmbH Emil-von-Behring-Strasse 76, 35041 Marburg, Germany
B06AC01
C1-ESTERASE INHIBITOR, HUMAN 3000 IU
POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
C1-ESTERASE INHIBITOR, HUMAN 3000 IU
POM
OTHER HEMATOLOGICAL AGENTS
Authorised
2018-01-10
Page 1 of 10 PACKAGE LEAFLET: INFORMATION FOR THE USER BERINERT 3000 3000 IU Powder and solvent for solution for injection. C1-esterase inhibitor, human 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 pharmacist. • 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 pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET: 1. What Berinert is and what it is used for 2. What you need to know before you use Berinert 3. How to use Berinert 4. Possible side effects 5. How to store Berinert 6. Contents of the pack and other information 1. WHAT BERINERT IS AND WHAT IT IS USED FOR _WHAT IS BERINERT? _ Berinert is presented as powder and solvent. The made up solution is to be given by injection under the skin. Berinert is made from human plasma (this is the liquid part of the blood). It contains the human protein C1-esterase inhibitor as active ingredient. _WHAT IS BERINERT USED FOR? _ Berinert is used for the prevention of recurrent hereditary angioedema (HAE) attacks in adolescent and adult patients. HAE is a congenital disease of the vascular system. It is a non- allergic disease. HAE is caused by deficiency, absence or defective synthesis of C1-esterase inhibitor, an important protein. The illness is characterised by the following symptoms: - swelling of the hands and feet that occurs suddenly, - facial swelling with tension sensation that occurs suddenly - eyelid swelling, lip swelling, possibly laryngeal (voice-box) swelling with difficulty in breathing, - tongue swelling, Page 2 of 10 - colic pain in abdominal region Generally, all parts of the body can be affected. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE BERINERT The Διαβάστε το πλήρες έγγραφο
Page 1 of 14 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Berinert 2000 2000 IU Powder and solvent for solution for injection Berinert 3000 3000 IU Powder and solvent for solution for injection. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Active substance: C1-esterase inhibitor (human) subcutaneous (s.c.) Berinert 2000 contains 2000 IU per injection vial. Berinert 3000 contains 3000 IU per injection vial. The potency of C1-esterase inhibitor is expressed in International Units (IU), which are related to the current WHO Standard for C1-esterase inhibitor products. Berinert 2000 contains 500 IU/ml C1-esterase inhibitor after reconstitution with 4 ml water for injections. Berinert 3000 contains 500 IU/ml C1-esterase inhibitor after reconstitution with 6 ml water for injections. The total protein content of the reconstituted solution is 65 mg/ml. Excipients with known effect: Sodium up to 486 mg (approximately 21 mmol) per 100 ml solution. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Berinert 2000 Powder and solvent for solution for injection Berinert 3000 Powder and solvent for solution for injection. White Powder. Page 2 of 14 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Berinert for subcutaneous injection is indicated for prevention of recurrent Hereditary Angioedema (HAE) attacks in adolescent and adult patients with C1-esterase inhibitor deficiency. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Berinert is intended for self-administration by subcutaneous injection. The patient or care giver should be trained on how to administer Berinert as needed. Posology The recommended dose of Berinert s.c. is 60 IU/kg body weight twice weekly (every 3-4 days) PAEDIATRIC POPULATION Posology in adolescents is the same as in adults. Method of administration Subcutaneous injection only For instructions on reconstitution of the medicinal product before administration see section 6.6. The suggested site for the subcutaneous injection of Berinert is the abdominal area. In the c Διαβάστε το πλήρες έγγραφο