Страна: Нідерланди
мова: голландська
Джерело: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
CLOFARABINE
Sandoz B.V. Veluwezoom 22 1327 AH ALMERE
L01BB06
CLOFARABINE
Concentraat voor oplossing voor infusie
NATRIUMCHLORIDE ; WATER VOOR INJECTIE,
Intraveneus gebruik
Clofarabine
Hulpstoffen: NATRIUMCHLORIDE; WATER VOOR INJECTIE;
2018-01-08
PACKAGE LEAFLET: INFORMATION FOR THE USER CLOFARABINE SANDOZ 1 MG/ML, CONCENTRAAT VOOR OPLOSSING VOOR INFUSIE CLOFARABINE 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. • 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 {[nationally completed name]} is and what it is used for 2. What you need to know before you use {[nationally completed name]} 3. How to use {[nationally completed name]} 4. Possible side effects 5. How to store {[nationally completed name]} 6. Contents of the pack and other information 1. WHAT {[NATIONALLY COMPLETED NAME]} IS AND WHAT IT IS USED FOR {[Nationally completed name]} contains the active substance clofarabine. Clofarabine is one of a family of medicines called anticancer medicines. It works by hindering the growth of abnormal white blood cells, and eventually kills them. It works best against cells which are multiplying quickly – such as cancer cells. {[Nationally completed name]} is used to treat children (≥ 1 year old), teenagers and young adults up to 21 years old with acute lymphoblastic leukaemia (ALL) when previous treatments have not worked or have stopped working. Acute lymphoblastic leukaemia is caused by abnormal growth of some types of white blood cells. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE {[NATIONALLY COMPLETED NAME]} DO NOT USE {[NATIONALLY COMPLETED NAME]}: - IF YOU ARE ALLERGIC to clofarabine or any of the other ingredients of this medicine (listed in section 6); - IF YOU ARE BREAST-FEEDING (please read the section “Pregnancy and breast-feeding” below); - IF YOU HAVE SEVERE KIDNEY OR LIVER PROBLEMS. TELL YOUR DOCTOR IF ANY OF THESE CONDITIONS APPLY TO YOU. If you are the parent of a child who is being treated with {[nationally completed name]}, TELL THE DOCTOR Прочитайте повний документ
Sandoz B.V. Page 1/22 Clofarabine Sandoz 1 mg/ml, concentraat voor oplossing voor infusie RVG 119525 V02 1.3.1.1 Summary of Product Characteristics Juni 2018 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Clofarabine Sandoz 1 mg/ml, concentraat voor oplossing voor infusie 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml of concentrate contains 1 mg of clofarabine. Each 20 ml vial contains 20 mg of clofarabine. Excipient with known effect Each 20 ml vial contains 180 mg of sodium chloride. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Concentrate for solution for infusion. Clear colourless solution with a pH of 4.5 to 7.5 and osmolarity of 270 to 310 mOsm/L. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of acute lymphoblastic leukaemia (ALL) in paediatric patients who have relapsed or are refractory after receiving at least two prior regimens and where there is no other treatment option anticipated to result in a durable response. Safety and efficacy have been assessed in studies of patients ≤ 21 years old at initial diagnosis (see section 5.1). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Adult population (including elderly) _ There are currently insufficient data to establish the safety and efficacy of clofarabine in adult patients (see section 5.2)._ _ _ _ _Paediatric population _ _Children and adolescents (≥ 1 year old) _ Sandoz B.V. Page 2/22 Clofarabine Sandoz 1 mg/ml, concentraat voor oplossing voor infusie RVG 119525 V02 1.3.1.1 Summary of Product Characteristics Juni 2018 The recommended dose in monotherapy is 52 mg/m 2 of body surface area administered by intravenous infusion over 2 hours daily for 5 consecutive days. Body surface area must be calculated using the actual height and weight of the patient before the start of each cycle. Treatment cycles should be repeated every 2 to 6 weeks (from the starting day of the previous cycle) following recovery of normal haematopoiesis (i.e. ANC ≥ 0.75 × 10 9 /l) and return to baseli Прочитайте повний документ