Država: Izrael
Jezik: engleski
Izvor: Ministry of Health
BLINATUMOMAB
AMGEN EUROPE B.V.
L01XC19
POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION
BLINATUMOMAB 35 MCG / 1 VIAL
I.V
Required
AMGEN EUROPE B.V., NETHERLANDS
BLINATUMOMAB
• BLINCYTO is indicated as monotherapy for the treatment of adults with CD19 positive relapsed or refractory B- precursor acute lymphoblastic leukaemia (ALL). Patients with Philadelphia chromosome positive B-precursor ALL should have failed treatment with at least 2 tyrosine kinase inhibitors (TKIs) and have no alternative treatment options.• BLINCYTO is indicated as monotherapy for the treatment of adults with Philadelphia chromosome negative CD19 positive B-precursor ALL in first or second complete remission with minimal residual disease (MRD) greater than or equal to 0.1%.• BLINCYTO is indicated as monotherapy for the treatment of pediatric patients aged 1 year or older with Philadelphia chromosome negative CD19 positive B-cell precursor ALL which is refractory or in relapse after receiving at least two prior therapies or in relapse after receiving prior allogeneic hematopoietic stem cell transplantation.• BLINCYTO is indicated as monotherapy for the treatment of pediatric patients aged 1 year or older with high-risk first relapsed Philadelphia chromosome negative CD19 positive B precursor ALL as part of the consolidation therapy.Limitations of use: After failure of two previous treatments and with no CNS involvement.
2021-06-30
1 PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS’ REGULATION ( PREPARATIONS) - 1986 This medicine is dispensed with a doctor’s prescription only. BLINCYTO ® 3 8. 5 MCG POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION ACTIVE INGREDIENT The active substance is blinatumomab. Each vial of powder contains 38.5 mcg of blinatumomab. For Inactive ingredients and allergens in the medicine – see section 6 ‘‘ Additional information’’ . READ THIS LEAFLET CAREFULLY AND UNTIL THE END BEFORE USING THIS MEDICINE. This leaflet contains concise information about the medicine. If you have additional questions, contact your doctor or pharmacist. This medicine is prescribed for treating your illness. Do not pass it on to others. It may cause them harm even if it appears to you that their medical condition is similar. 1. WHAT IS THIS MEDICINE INTENDED FOR? • BLINCYTO is indicated as monotherapy for the treatment of adults with CD19 positive relapsed or refractory B-precursor acute lymphoblastic leukemia (ALL). Patients with Philadelphia chromosome positive B-precursor ALL should have failed treatment with at least 2 tyrosine kinase inhibitors (TKIs) and have no alternative treatment options. • BLINCYTO is indicated as monotherapy for the treatment of adults with Philadelphia chromosome negative CD19 positive B-precursor ALL in first or second complete remission with minimal residual disease (MRD) greater than or equal to 0.1%. • BLINCYTO is indicated as monotherapy for the treatment of pediatric patients aged 1 year or older with Philadelphia chromosome negative CD19 positive B-precursor ALL which is refractory or in relapse after receiving at least two prior therapies or in relapse after receiving prior allogeneic hematopoietic stem cell transplantation. • BLINCYTO is indicated as monotherapy for the treatment of pediatric patients aged 1 year or older with high-risk first relapsed Philadelphia chromosome negative CD19 positive B-precursor ALL as part of the consolidation therapy. In addition to the patient Pročitajte cijeli dokument
1 _Revised in November 2023 according to MoHs guidelines. _ 1. NAME OF THE MEDICINAL PRODUCT BLINCYTO 38.5 micrograms powder for concentrate and solution for solution for infusion. _ _ 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One vial of powder contains 38.5 micrograms blinatumomab. Reconstitution with water for injections results in a final blinatumomab concentration of 12.5 micrograms/mL. Blinatumomab is produced in Chinese hamster ovary cells by recombinant DNA technology. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Powder for concentrate and solution for solution for infusion. BLINCYTO powder (powder for concentrate): White to off-white powder. Solution (stabilizer): Colorless-to-slightly yellow, clear solution with a pH of 7.0. 4. CLINICAL PARTICULARS Prescriber guide This product is marketed with prescriber guide providing important safety information. Please ensure you are familiar with this material as it contains important safety information. Patient safety information materials: BLINCYTO Patient Alert Card and BLINCYTO Guide for Patients and Caregivers This product is marketed with patient safety information materials (patient card and patient guide). Please explain to the patient the implications of this treatment including the need for compliance. Please also explain the signs of important adverse reactions and instruct the patient when to seek medical care. 4.1 Therapeutic indications BLINCYTO _ _ is indicated as monotherapy for the treatment of adults with CD19 positive relapsed or refractory B-precursor acute lymphoblastic leukemia (ALL). Patients with Philadelphia chromosome positive B-precursor ALL should have failed treatment with at least 2 tyrosine kinase inhibitors (TKIs) and have no alternative treatment options. BLINCYTO is indicated as monotherapy for the treatment of adults with Philadelphia chromosome negative CD19 positive B-precursor ALL in first or second complete remission with minimal residual disease (MRD) greater than or equal to 0.1%. BLINCYTO is i Pročitajte cijeli dokument