Երկիր: Իռլանդիա
Լեզու: անգլերեն
Աղբյուրը: HPRA (Health Products Regulatory Authority)
Cristanspase
Jazz Pharmaceuticals France SAS
L01XX; L01XX02
Cristanspase
10000 international unit(s)
Powder for solution for injection
Product subject to prescription which may not be renewed (A)
Other antineoplastic agents; asparaginase
Marketed
1998-09-18
Ireland August 2016 page 20 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT ERWINASE ® 10.000 Units, Powder for solution for injection Crisantaspase (Asparaginase from _Erwinia chrysanthemi_; _Erwinia_ L-asparaginase) READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START RECEIVING 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 side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. WHAT IS IN THIS LEAFLET 1. What Erwinase is and what it is used for. 2. What you need to know before you take Erwinase. 3. How to take Erwinase. 4. Possible side effects. 5. How to store Erwinase. 6. Contents of the pack and other information. 1. WHAT ERWINASE IS AND WHAT IT IS USED FOR Erwinase contains asparaginase from _Erwinia chrysanthemi_. Erwinase is an anti-blood-cell-cancer medicine. It is used in combination with other anticancerous agents to treat Acute Lymphoblastic Leukaemia, a type of blood-cell-cancer. 2. WHAT YOU NEED TO KNOW BEFORE YOU RECEIVE ERWINASE DO NOT USE ERWINASE: - If you are allergic (hypersensitive) to crisantaspase (_Erwinia_ L-asparaginase) or any of the other ingredients of this medicine (listed in section 6). - If you have a history of pancreas problems (acute pancreatitis). - If you are having a baby, trying to have a baby or if you are breast-feeding. WARNINGS AND PRECAUTIONS - Crisantaspase (Erwinia L-asparaginase) is a substance which your body may become sensitive to after repeated treatments. - Treatment with Erwinase can sometimes affect the results of certain blood or urine tests. Your doctor will be aware of this and may carry out routine blood tests before and during your treatment to check for any changes. - Treatment with Erwinase may make you more susceptible to infection. - Posterior reversible encephalopathy syndrome (characterised by headache, confusion, seizures Ireland August 2016 pag Կարդացեք ամբողջական փաստաթուղթը
Health Products Regulatory Authority 03 March 2020 CRN008VDT Page 1 of 11 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Erwinase 10,000 Units. Powder for solution for injection 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Crisantaspase (Asparaginase from _Erwinia chrysanthemi_; _Erwinia_ L-asparaginase), 10,000 Units/vial. Excipients with known effect: Glucose monohydrate: 5 mg / vial Sodium chloride: 0.5 mg / vial For a full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Powder for solution for injection. White solid in a vial. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Erwinase is used in combination with other antineoplastic agents to treat acute lymphoblastic leukaemia. Patients receiving treatment with L-asparaginase from _Escherichia coli_ and who develop hypersensitivity to that enzyme may be able to continue treatment with Erwinase as the enzymes are immunologically distinct. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Erwinase should be prescribed and administered by physicians and/or health care personnel experienced in the use of antineoplastic products. It should only be given in a hospital setting where appropriate resuscitation equipment is available. Patients should be closely monitored and carefully observed for any adverse reactions throughout the administration period (see section 4.4). Posology Reference to current recognised acute lymphoblastic leukaemia protocols should be made for information on dose, route and frequency of treatment. Method of administration Erwinase solution can be given by intravenous infusion or intramuscular injection. For IV infusion, it is recommended that the reconstituted Erwinase solution be further diluted in 100 mL of normal saline and administered over 1 to 2 hours. For instructions on reconstitution of the medicinal product before administration, see section 6.6. 4.3 CONTRAINDICATIONS History of severe hypersensitivity reaction to crisantaspase or to any of the excipients listed in section 6.1 Current or past severe p Կարդացեք ամբողջական փաստաթուղթը