البلد: إسرائيل
اللغة: الإنجليزية
المصدر: Ministry of Health
DARATUMUMAB
J-C HEALTH CARE LTD
L01XC24
CONCENTRATE FOR SOLUTION FOR INFUSION
DARATUMUMAB 20 MG / 1 ML
I.V
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 st em 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
2022-01-31
PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS (PREPARATIONS) – 1986 This medicine is dispensed with a doctor’s prescription only Darzalex ® 20 mg/ml I.V Concentrate for solution for infusion The active ingredient and its concentration Daratumumab 20 mg/ml For a list of the inactive and allergenic ingredients in this preparation – see section 6 “Further Information”. See also “Important information about some of the ingredients of the medicine” in section 2. Read this leaflet carefully in its entirety before using the medicine. This leaflet contains concise information about the medicine. If you have further questions, refer to the doctor or pharmacist. This medicine has been prescribed for the treatment of your ailment. Do not pass it on to others. It may harm them, even if it seems to you that their ailment is similar. Patient Information Card: In addition to this leaflet, Darzalex 20 mg/ml I.V is provided with a Patient Safety Information Card. This card contains important safety information you should be aware of before starting and during treatment with Darzalex 20 mg/ml I.V, and adhere to. Read the Patient Safety Information Card and the patient leaflet before you start using the preparation. Keep the card for further reading, if necessary. 1. WHAT IS THE MEDICINE INTENDED FOR? • Darzalex 20 mg/ml I.V in combination with lenalidomide and dexamethasone, or in combination with bortezomib, melphalan and prednisone, is intended for the treatment of adult patients with newly diagnosed multiple myeloma, which is a cancer of the bone marrow, and who are ineligible for autologous stem cell transplant. • Darzalex 20 mg/ml I.V in combination with bortezomib, thalidomide and dexamethasone is intended for the treatment of adult patients with newly diagnosed multiple myeloma, who are eligible for autologous stem cell transplant. • Darzalex 20 mg/ml I.V in combination with lenalidomide and dexamethasone, or in combination with bortezomib and dexamethasone, is intended for th اقرأ الوثيقة كاملة
Darzalex 20mg-ml IV-100mg_400mg_ concentrate for solution for infusion_SPC_02_2023_sub 1. NAME OF THE MEDICINAL PRODUCT DARZALEX 20 mg/mL I.V. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each 5 mL vial contains 100 mg of daratumumab (20 mg daratumumab per mL). Each 20 mL vial contains 400 mg of daratumumab (20 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 5 mL and 20 mL vial of DARZALEX 20MG/ML I.V contains 0.4 mmol and 1.6 mmol (9.3 mg and 37.3 mg) sodium, respectively. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Concentrate for solution for infusion. The solution is colourless to yellow. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS DARZALEX 20MG/ML I.V 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 20MG/ML I.V should be administered by a healthcare professional, in an environment where resuscitation facilities are available. Pre- and post-infusion medicinal products should be administered to reduce the risk of infusion-related reaction اقرأ الوثيقة كاملة