Country: Unjoni Ewropea
Lingwa: Ingliż
Sors: EMA (European Medicines Agency)
asparaginase
Medac Gesellschaft fuer klinische Spezialpraeparate mbH
L01XX02
asparaginase
Antineoplastic agents
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Spectrila is indicated as a component of antineoplastic combination therapy for the treatment of acute lymphoblastic leukaemia (ALL) in paediatric patients from birth to 18 years and adults.
Revision: 6
Authorised
2016-01-14
25 B. PACKAGE LEAFLET 26 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT SPECTRILA 10,000 U POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION asparaginase READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN 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 nurse. - If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Spectrila is and what it is used for 2. What you need to know before you are given Spectrila 3. How to use Spectrila 4. Possible side effects 5. How to store Spectrila 6. Contents of the pack and other information 1. WHAT SPECTRILA IS AND WHAT IT IS USED FOR Spectrila contains asparaginase, which is an enzyme that interferes with natural substances necessary for cancer cell growth. All cells need an amino acid called asparagine to stay alive. Normal cells can make asparagine for themselves, while some cancer cells cannot. Asparaginase lowers asparagine level in blood cancer cells and stops the cancer growing. Spectrila is used to treat adults and children with acute lymphoblastic leukaemia (ALL) which is a form of blood cancer. Spectrila is used as part of a combination therapy. 2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN SPECTRILA SPECTRILA MUST NOT BE USED • if you are allergic to asparaginase or to the other ingredient of this medicine (listed in section 6), • if you have or previously had inflammation of the pancreas (pancreatitis), • if you have severe liver function problems, • if you have a blood clotting disorder (such as haemophilia), • if you had severe bleeding (haemorrhage) or severe blood clotting (thrombosis) under previous asparaginase treatment. WARNINGS AND PRECAUTIONS Talk to your doctor or nurse before you are given Spectrila. The following life-threatening situations could arise during treatment with Spectrila: • severe inflamm Aqra d-dokument sħiħ
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Spectrila 10,000 U powder for concentrate for solution for infusion 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial of powder contains 10,000 units of asparaginase*. After reconstitution, each ml of solution contains 2,500 units of asparaginase. One unit (U) is defined as the quantity of enzyme required to liberate one µmol ammonia per minute at pH 7.3 and 37 °C. *Produced in _Escherichia coli _ cells by recombinant DNA technology. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Powder for concentrate for solution for infusion. White powder. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Spectrila is indicated as a component of antineoplastic combination therapy for the treatment of acute lymphoblastic leukaemia (ALL) in paediatric patients from birth to 18 years and adults. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Spectrila should be prescribed and administered by physicians and healthcare personnel experienced in the use of antineoplastic products. It should only be given in a hospital setting where appropriate resuscitation equipment is available. Posology Spectrila is usually employed as part of combination chemotherapy protocols with other antineoplastic agents (see also section 4.5). _Adults and children older than 1 year _ The recommended intravenous dose of asparaginase is 5,000 units per square metre (U/m²) body surface area (BSA) given every third day. Treatment may be monitored based on the trough serum asparaginase activity measured three days after administration of Spectrila. If asparaginase activity values fail to reach target levels, a switch to a different asparaginase preparation could be considered (see section 4.4). _Children 0 – 12 months old _ Based on limited data, the recommended dose in infants is as follows: - age less than 6 months: 6,700 U/m² BSA, - age 6 – 12 months: 7,500 U/m² BSA. 3 Data on efficacy and safety of Spectrila in adults are limited. Data on effic Aqra d-dokument sħiħ