Država: Europska Unija
Jezik: engleski
Izvor: EMA (European Medicines Agency)
Recombinant human C1-inhibitor
Pharming Group N.V.
B06AC04
conestat alfa
Drugs used in hereditary angioedema, Other hematological agents
Angioedemas, Hereditary
Ruconest is indicated for treatment of acute angioedema attacks in adults with hereditary angioedema (HAE) due to C1-esterase-inhibitor deficiency.
Revision: 12
Authorised
2010-10-28
35 B. PACKAGE LEAFLET 36 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT RUCONEST 2100 UNITS POWDER FOR SOLUTION FOR INJECTION conestat alfa 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. - 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. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Ruconest is and what it is used for 2. What you need to know before you use Ruconest 3. How to use Ruconest 4. Possible side effects 5. How to store Ruconest 6. Contents of the pack and other information 1. WHAT RUCONEST IS AND WHAT IT IS USED FOR Ruconest contains conestat alfa as the active substance. Conestat alfa is a recombinant (not blood-derived) form of human C1 inhibitor (rhC1-INH). Ruconest is to be used by adults, adolescents, and children (aged 2 years and above) with a rare inherited blood disorder, called Hereditary Angioedema (HAE). These patients have a shortage of the C1 inhibitor protein in their blood. This can lead to repeated attacks of swelling, pain in the abdomen, difficulty breathing and other symptoms. The administration of Ruconest is to resolve the shortage of C1 inhibitor and will lead to reduction of symptoms of an acute attack of HAE. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE RUCONEST DO NOT USE RUCONEST • If you are or think you are allergic to rabbits. • If you are allergic to conestat alfa or any of the other ingredients of this medicine (listed in section 6). WARNINGS AND PRECAUTIONS Talk to your doctor before using Ruconest. If you experience allergic reactions e.g. hives, rash, itching, dizziness, wheezing, difficulty breathing or your tongue swells up following the administration of Ruconest, you shoul Pročitajte cijeli dokument
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Ruconest 2100 Units powder for solution for injection. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One vial contains 2100 units of conestat alfa, corresponding to 2100 units per 14 ml after reconstitution, or a concentration of 150 units/ml. Conestat alfa is a recombinant analogue of the human C1 esterase inhibitor (rhC1-INH) produced by recombinant DNA technology in the milk of transgenic rabbits. 1 unit of conestat alfa activity is defined as the equivalent of C1 esterase inhibiting activity present in 1 ml of pooled normal plasma. Excipient with known effect: Each vial contains approximately 19.5 mg sodium. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Powder for solution for injection. White to off-white powder. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Ruconest is indicated for treatment of acute angioedema attacks in adults, adolescents, and children (aged 2 years and above) with hereditary angioedema (HAE) due to C1 esterase inhibitor deficiency. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Ruconest should be initiated under the guidance and supervision of a physician experienced in the diagnosis and treatment of hereditary angioedema. Posology in adults, adolescents and children aged 2 years and above _Body weight up to 84 kg _ - One intravenous injection of 50 U/kg body weight. _Body weight of 84 kg or greater _ - One intravenous injection of 4200 U (2 vials). In the majority of cases, a single dose of Ruconest is sufficient to treat an acute angioedema attack. In case of an insufficient clinical response, an additional dose (50 U/kg body weight up to 4200 U) can be administered at the discretion of the physician (see section 5.1). - In adults and adolescents an additional dose may be administered if the patient has not responded adequately after 120 minutes. - In children an additional dose may be administered if the patient has not responded adequately after 60 minutes. Not more than two do Pročitajte cijeli dokument