البلد: إسرائيل
اللغة: الإنجليزية
المصدر: Ministry of Health
DARATUMUMAB
J-C HEALTH CARE LTD
L01XC24
SOLUTION FOR INJECTION
DARATUMUMAB 120 MG / 1 ML
S.C
Required
CILAG AG, SWITZERLAND
DARATUMUMAB
DARZALEX is indicated:• in combination with lenalidomide and dexamethasone or with bortezomib, melphalan and prednisone for the treatment of adult patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant.• in combination with bortezomib, thalidomide and dexamethasone for the treatment of adult patients with newly diagnosed multiple myeloma who are eligible for autologous stem cell transplant.• in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least one prior therapy.• as monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma, whose prior therapy included a proteasome inhibitor and an immunomodulatory agent and who have demonstrated disease progression on the last therapy.
2021-04-11
PATIENT CARD IN CASE OF EMERGENCY, OR IF YOU FIND THIS CARD, PLEASE CONTACT THE DOCTOR LISTED BELOW: Doctor’s Name/Clinic, Center or Hospital Name: Telephone number: IMPORTANT MEDICAL INFORMATION INSIDE DARZALEX 20 MG/ML IV DARZALEX 120 MG/ML SC, 1800 MG Patient Card DAR P-ID-ENG-CARD SH010821 DARZALEX PATIENTS: PROVIDE THIS CARD TO HEALTHCARE PROVIDERS BEFORE BLOOD TRANSFUSION AND CARRY IT FOR 6 MONTHS AFTER TREATMENT HAS ENDED. FOR FURTHER INFORMATION PLEASE REFER TO THE PATIENT INFORMATION LEAFLET PATIENT ID CARD FOR DARZALEX Name: _____________________________________________ I AM TAKING THE FOLLOWING MEDICATION: Daratumumab antibody product for the treatment of multiple myeloma Stopped taking this medication ______ _ _ / ________ / ________ DD MM YYYY DEAR HEALTHCARE PROVIDER, Daratumumab is associated with the risk of interference with blood typing. The Indirect Coombs test may show positive results in patients taking daratumumab, even in the absence of antibodies to minor blood antigens in the patient’s serum. The chance of this disturbance can persist for up to 6 months after the last dose of daratumumab. The determination of a patient’s ABO and Rh blood type are not impacted. If an emergency transfusion is required, non-cross-matched, ABO/RhD-compatible RBCs can be given per local blood bank practices. BEFORE STARTING DARATUMUMAB MY BLOOD TEST RESULTS COLLECTED ON _______ / _______ / _______ WERE: DD MM YYYY Blood type: □ A □ B □ AB □ O □ Rh+ □ Rh- INDIRECT COOMBS TEST (ANTIBODY SCREEN) WAS: □ Negative □ Positive for the following antibodies: ________________________________________________ Contact details of the institution where the blood tests were performed: _______________________________________ The format and the content of this card were updated and approved by the Ministry of Health in July 2021. For further information, read the patient leaflet. Side effects can be reported to the Ministry of Health by using an online form for reporting side effects found on the Ministr اقرأ الوثيقة كاملة
DARZALEX 120 mg/ml S.C 08_2023_sub 1. NAME OF THE MEDICINAL PRODUCT DARZALEX 120 MG/ML S.C. 1,800 MG 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each 15 mL vial of solution for injection contains 1,800 mg of daratumumab (120 mg daratumumab per mL). Daratumumab is a human monoclonal IgG1κ antibody against CD38 antigen, produced in a mammalian cell line (Chinese Hamster Ovary) using recombinant DNA technology. Excipient with known effect Each 15 mL vial of solution for injection contains 735.1 mg of sorbitol (E420). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection. The solution is clear to opalescent, colourless to yellow. 4. CLINICAL PARTICULARS 4.1 Therapeutic indications DARZALEX 120MG/ML S.C. 1,800MG is indicated: • in combination with lenalidomide and dexamethasone or with bortezomib, melphalan and prednisone for the treatment of adult patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant. • in combination with bortezomib, thalidomide and dexamethasone for the treatment of adult patients with newly diagnosed multiple myeloma who are eligible for autologous stem cell transplant. • in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least one prior therapy. • as monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma, whose prior therapy included a proteasome inhibitor and an immunomodulatory agent and who have demonstrated disease progression on the last therapy. 4.2 Posology and method of administration DARZALEX 120MG/ML S.C. 1,800MG subcutaneous formulation is not intended for intravenous administration and should be given by subcutaneous injection only, using the doses specified. DARZALEX 120MG/ML S.C. 1,800MG should be administered by a healthcare professional, and the first dose should be administered in an environment where resuscitation facilities are ava اقرأ الوثيقة كاملة