Country: Irlanda
Lingwa: Ingliż
Sors: HPRA (Health Products Regulatory Authority)
Lenograstim
Chugai Pharma France
L03AA; L03AA10
Lenograstim
34 million international unit(s)/millilitre
Powder and solvent for solution for injection/infusion
Colony stimulating factors; lenograstim
Marketed
2009-09-01
_ _ September 2022 CONFIDENTIAL Page 1 of 10 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT GRANOCYTE 13 MILLION IU/ML, POWDER AND SOLVENT FOR SOLUTION FOR INJECTION/INFUSION IN A PRE- FILLED SYRINGE GRANOCYTE 34 MILLION IU/ML, POWDER AND SOLVENT FOR SOLUTION FOR INJECTION/INFUSION IN A PRE- FILLED SYRINGE Lenograstim READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING 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 pharmacist • 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 or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET : 1. What Granocyte is and what it is used for 2. What you need to know before you take Granocyte 3. How to take Granocyte 4. Possible side effects 5. How to store Granocyte 6. Contents of the pack and other information 1. WHAT GRANOCYTE IS AND WHAT IT IS USED FOR The name of your medicine is Granocyte, powder and solvent for injection/infusion (called Granocyte in this leaflet). Granocyte contains a medicine called lenograstim. This belongs to a group of medicines called cytokines. Granocyte works by helping your body to make more of the blood cells which fight infection. • These blood cells are made in your bone marrow. • Granocyte encourages your bone marrow to make more cells called ‘blood stem cells’. • It then helps turn these young blood cells into fully working blood cells. • In particular, it helps produce more white blood cells called neutrophils. Neutrophils are important in fighting infections. GRANOCYTE IS USED: • AFTER CANCER TREATMENT, IF THE LEVEL OF YOUR WHITE BLOOD CELLS IS TOO LOW (CALLED ‘NEUTROPENIA’) Some treatments for cancer (also called ‘chemotherapy’) affect the bone marrow. This can lower the Aqra d-dokument sħiħ
Health Products Regulatory Authority 08 December 2022 CRN00D6Q7 Page 1 of 11 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT GRANOCYTE 34 million IU/mL, powder and solvent for solution for injection/infusion, in a pre-filled syringe 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Lenograstim* (rHuG-CSF) 33.6 million International Units (equivalent to 263 micrograms) per mL after reconstitution *Produced by recombinant DNA technology in Chinese Hamster Ovary (CHO) cells. Excipients with known effect: Phenylalanine For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Powder and solvent for solution for injection/infusion, in a pre-filled syringe. - White powder - _Solvent: _clear, colourless solution 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS GRANOCYTE is indicated in adults, adolescents and children aged older than 2 years for: The reduction of the duration of neutropenia in patients (with non myeloid malignancy) undergoing myeloablative therapy followed by bonemarrow transplantation (BMT) and considered to be at increased risk of prolonged severe neutropenia. The reduction of the duration of severe neutropenia and its associated complications in patients undergoing established cytotoxic therapy associated with a significant incidence of febrile neutropenia. The mobilisation of peripheral blood progenitor cells (PBPCs), for patients as well as healthy donors. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Method of administration GRANOCYTE can be administered by sub-cutaneous injection or by intravenous infusion. Particular handling of the product or instructions for preparation are given in sections 6.6. Posology Therapy should only be given in collaboration with an experienced oncology and/or haematology centre. The recommended dose of GRANOCYTE is 19.2 MIU (150 micrograms) per m 2 per day, therapeutically equivalent to 0.64 MIU (5 micrograms) per kg per day for: Peripheral Stem Cells or bone marrow transplantation, established cytotoxic chemotherapy PB Aqra d-dokument sħiħ