Země: Austrálie
Jazyk: angličtina
Zdroj: Department of Health (Therapeutic Goods Administration)
daratumumab, Quantity: 1800 mg
Janssen-Cilag Pty Ltd
Injection, solution
Excipient Ingredients: vorhyaluronidase alfa; histidine; histidine hydrochloride monohydrate; sorbitol; methionine; polysorbate 20; water for injections
Subcutaneous
1
(S4) Prescription Only Medicine
DARZALEX SC is indicated for the treatment of patients:,? with newly diagnosed multiple myeloma:,- who are eligible for autologous stem cell transplant. For use in combination with:-bortezomib, thalidomide, and dexamethasone.,- who are ineligible for autologous stem cell transplant. For use in combination with: - bortezomib, melphalan and prednisone, or - lenalidomide and dexamethasone.,? with multiple myeloma who have received: - at least one prior therapy. For use in combination with: - bortezomib and dexamethasone, or - lenalidomide and dexamethasone.,- at least three prior lines of therapy including a proteasome inhibitor (PI) and an immunomodulatory agent or who are refractory to both a PI and an immunomodulatory agent. For use as: - monotherapy.,DARZALEX SC in combination with bortezomib, cyclophosphamide and dexamethasone, is indicated for the treatment of patients with light chain AL amyloidosis.
Visual Identification: Colourless to yellow, clear to opalescent, preservative-free solution; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 24 Months; Container Temperature: Store at 2 to 8 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Registered
2020-09-08
DARZALEX SC (211208) ACMI 1 DARZALEX ® SC _SOLUTION FOR INJECTION _ _Daratumumab _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about DARZALEX SC Solution for injection. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you being given DARZALEX SC against the benefits this medicine is expected to have for you. IF YOU HAVE ANY CONCERNS ABOUT BEING GIVEN DARZALEX SC ASK YOUR DOCTOR. KEEP THIS LEAFLET WHILE YOU ARE BEING TREATED WITH DARZALEX SC. You may need to read it again. WHAT DARZALEX SC IS USED FOR DARZALEX SC is an anti-cancer medicine and contains the active substance daratumumab. This belongs to a group of medicines called “monoclonal antibodies”. One of the ways monoclonal antibodies work is by attaching themselves to specific abnormal blood cells in your body, so your immune system can destroy them. DARZALEX SC is used to treat adults with multiple myeloma (cancer of the bone marrow). DARZALEX SC is also used to treat adults with AL amyloidosis (also known as light chain amyloidosis, a type of blood disorder). In AL amyloidosis, abnormal blood cells make excessive amounts of abnormal proteins that deposit in various organs, causing these organs to not function properly. Your doctor may have prescribed DARZALEX SC for another reason. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY DARZALEX SC HAS BEEN PRESCRIBED FOR YOU. THIS MEDICINE IS AVAILABLE ONLY WITH A DOCTOR'S PRESCRIPTION. BEFORE YOU ARE GIVEN DARZALEX SC _WHEN YOU MUST NOT USE IT: _ DO NOT USE DARZALEX SC IF: • you know you are allergic (hypersensitive) to daratumumab or other ingredients of DARZALEX SC. See Product Description at the end of this leaflet for a list of ingredients. SYMPTOMS OF AN ALLERGIC REACTION MAY INCLUDE RASH, ITCHING OR HIVES ON THE SKIN, SHORTNESS OF BREATH, WHEEZING OR DIFFICULTY BREATHING, SWELLING OF THE FACE, LIPS, Přečtěte si celý dokument
_ _ CCDSv10 210413 1 DARZALEX SC (211116) API DARZALEX ® SC DARATUMUMAB SOLUTION FOR INJECTION AUSTRALIAN PRODUCT INFORMATION 1. NAME OF THE MEDICINE Daratumumab. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 15 mL vial: Each single-use vial contains 1800 mg of daratumumab (120 mg/mL). Daratumumab is an immunoglobulin G1 kappa (IgG1κ) human monoclonal antibody against CD38 antigen, produced in a mammalian cell line (Chinese Hamster Ovary [CHO]) using recombinant DNA technology. Recombinant human hyaluronidase (rHuPH20; vorhyaluronidase alfa) is an endoglycosidase used to increase the dispersion and absorption of co-administered drugs when administered subcutaneously. It is produced by mammalian CHO cells containing a DNA plasmid encoding for a soluble fragment of human hyaluronidase (PH20). It is a glycosylated single-chain protein with an approximate molecular weight of 61 kD. For a full list of excipients, see section 6.1 List of excipients. 3. PHARMACEUTICAL FORM DARZALEX SC is available as a colourless to yellow, clear to opalescent, preservative-free solution for subcutaneous administration. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS DARZALEX SC is indicated for the treatment of patients: • with newly diagnosed multiple myeloma: - who are eligible for autologous stem cell transplant. For use in combination with: bortezomib, thalidomide, and dexamethasone. - who are ineligible for autologous stem cell transplant. For use in combination with: bortezomib, melphalan and prednisone, or lenalidomide and dexamethasone. • with multiple myeloma who have received: - at least one prior therapy. For use in combination with: bortezomib and dexamethasone, or lenalidomide and dexamethasone. - at least three prior lines of therapy including a proteasome inhibitor (PI) and an immunomodulatory agent or who are refractory to both a PI and an immunomodulatory agent. For use as: monotherapy. _ _ CCDSv10 210413 2 DARZALEX SC (211116) API DARZALEX SC in combination with bortezomib, cyclophospha Přečtěte si celý dokument