Země: Izrael
Jazyk: angličtina
Zdroj: Ministry of Health
C - 1 ESTERASE INHIBITOR HUMAN
CSL BEHRING LTD., ISRAEL
B06AC01
POWDER FOR SOLUTION FOR INJ/INF
C - 1 ESTERASE INHIBITOR HUMAN 500 IU/VIAL
I.V
Required
CSL BEHRING GmbH, GERMANY
C1- INHIBITOR,PLASMA DERIVED
C1- INHIBITOR,PLASMA DERIVED
Hereditary angioedema type I and II (HAE).Treatment and pre-procedure (prior to oral, dental, and upper respiratory tract procedures) prevention of acute episodes
2015-12-31
PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS ’ REGULATIONS (PREPARATIONS) - 1986 This medicine can be sold with a physician's prescription only BERINERT IS USUALLY INJECTED INTO A VEIN (INTRAVENOUSLY) BY THE PHYSICIAN OR NURSE. YOU OR YOUR CARER MIGHT ALSO ADMINISTER BERINERT AS AN INJECTION BUT ONLY AFTER RECEIVING ADEQUATE TRAINING. IF YOUR PHYSICIAN DECIDES THAT YOU ARE SUITABLE FOR HOME-TREATMENT, DETAILED INSTRUCTIONS WILL BE GIVEN TO YOU. YOU WILL BE REQUIRED TO KEEP A DIARY IN ORDER TO DOCUMENT EACH TREATMENT RECEIVED AT HOME AND TO BRING IT TO EACH OF YOUR VISITS TO THE PHYSICIAN. REGULAR REVIEW OF YOUR OR YOUR CARER’S INJECTION TECHNIQUE WILL BE PERFORMED TO ENSURE CONTINUED APPROPRIATE HANDLING. BERINERT ® POWDER AND SOLVENT FOR SOLUTION FOR INJECTION / INFUSION 500 IU The active ingredient and its quantity: The vial with the powder contains: C1 - Esterase Inhibitor Human 500 IU For list of excipients, please see section 6. READ THIS ENTIRE LEAFLET CAREFULLY BEFORE YOU USE THIS MEDICINE. This leaflet contains concise information about the medicine. If you have any further questions, ask your physician or pharmacist. This medicine has been prescribed for the treatment of your illness. Do not pass it on to others. It may harm them, even if you think that their illness is the same as yours. 1. WHAT IS THE MEDICINE USED FOR? • Hereditary angioedema type I and II (HAE) • Treatment and pre-procedure (prior to oral, dental, and upper respiratory tract procedures) prevention of acute episodes. Hereditary Angioedema is a congenital, non-allergic disease of the vascular system. Hereditary Angioedema is caused by deficiency, absence or defective synthesis of C1- esterase inhibitor which is an important protein. The illness is characterized 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 breathing difficulties - tongue swel Přečtěte si celý dokument
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT BERINERT ® 500 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION / INFUSION. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Active substance: human C1-esterase inhibitor (from human plasma). Berinert contains 500 IU per injection vial. The potency of human C1-esterase inhibitor is expressed in International Units (IU), which are related to the current WHO Standard for C1-esterase inhibitor products. Berinert 500 contains 50 IU/ml human C1-esterase inhibitor after reconstitution with 10 ml water for injections. The total protein content of the reconstituted 500 IU solution is 6.5 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 Powder and solvent for solution for injection / infusion. White Powder. Clear, colourless solvent. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Hereditary angioedema type I and II (HAE) Treatment and pre-procedure (prior to oral, dental, and upper respiratory tract procedures) prevention of acute episodes. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Treatment should be initiated under the supervision of a physician experienced in the treatment of C1-esterase inhibitor deficiency. _POSOLOGY _ _ _ ADULTS Treatment of acute angioedema attacks: 20 IU per kilogram body weight (20 IU/kg b.w.) Pre-procedure prevention of angioedema attacks: 1000 IU less than 6 hours prior to oral, dental, and upper respiratory tract procedures. PAEDIATRIC POPULATION Treatment of acute angioedema attacks: 20 IU per kilogram body weight (20 IU/kg b.w.). Pre-procedure prevention of angioedema attacks: 15 to 30 IU per kilogram body weight (15-30 IU/kg b.w.) less than 6 hours prior to oral, dental, and upper respiratory tract procedures. Dose should be selected taking into account clinical circumstances (e.g. type of procedure and disease severity). _METHOD OF ADMINISTRATION _ Berinert is to be reconstituted according to secti Přečtěte si celý dokument