Država: Velika Britanija
Jezik: engleski
Izvor: MHRA (Medicines & Healthcare Products Regulatory Agency)
Ofatumumab
Novartis Pharmaceuticals UK Ltd
Ofatumumab
20mg/1ml
Solution for infusion
Intravenous
No Controlled Drug Status
Valid as a prescribable product
BNF: ; GTIN: 5000123113873
1 PACKAGE LEAFLET: INFORMATION FOR THE USER ARZERRA ® 100 MG CONCENTRATE FOR SOLUTION FOR INFUSION ARZERRA ® 1000 MG CONCENTRATE FOR SOLUTION FOR INFUSION ofatumumab READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN 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 nurse. - If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Arzerra is and what it is used for 2. What you need to know before you are given Arzerra 3. How Arzerra is given 4. Possible side effects 5. How to store Arzerra 6. Contents of the pack and other information 1. WHAT ARZERRA IS AND WHAT IT IS USED FOR Arzerra contains ofatumumab, which belongs to a group of medicines called monoclonal antibodies. ARZERRA IS USED TO TREAT CHRONIC LYMPHOCYTIC LEUKAEMIA (CLL). CLL is a cancer of the blood which affects a type of white blood cell called lymphocytes. The lymphocytes multiply too quickly and live too long, so there are too many of them circulating in your blood. The disease can also affect other organs in your body. The antibody in Arzerra recognises a substance on the surface of lymphocytes and causes the lymphocyte to die. 2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN ARZERRA YOU MUST NOT BE GIVEN ARZERRA: if you are allergic (hypersensitive) to ofatumumab or any of the other ingredients of this medicine (listed in section 6). Check with your doctor if you think this may apply to you. WARNINGS AND PRECAUTIONS Talk to your doctor or nurse before you are given Arzerra: if you have had HEART PROBLEMS, if you have LUNG DISEASE, Check with your doctor if you think any of these may apply to you. You may need extra check-ups while you are being treated with Arzerra. Your doctor may test the amount of electrolytes, such as magnesium and potassium, in your blood before and during your treatment w Pročitajte cijeli dokument
OBJECT 1 ARZERRA 100MG CONCENTRATE FOR SOLUTION FOR INFUSION Summary of Product Characteristics Updated 24-Aug-2017 | Novartis Pharmaceuticals UK Ltd 1. Name of the medicinal product Arzerra ® 100 mg concentrate for solution for infusion Arzerra ® 1000 mg concentrate for solution for infusion 2. Qualitative and quantitative composition One ml of concentrate contains 20 mg of ofatumumab. Arzerra 100 mg concentrate for solution for infusion Each vial contains 100 mg of ofatumumab in 5 ml. Arzerra 1000 mg concentrate for solution for infusion Each vial contains 1000 mg of ofatumumab in 50 ml. Ofatumumab is a human monoclonal antibody produced in a recombinant murine cell line (NS0). Excipient with known effect This medicinal product contains 34.8 mg sodium per 300 mg dose, 116 mg sodium per 1000 mg dose and 232 mg sodium per 2000 mg dose. For the full list of excipients, see section 6.1. 3. Pharmaceutical form Concentrate for solution for infusion (sterile concentrate). Clear to opalescent, colourless to pale yellow liquid. 4. Clinical particulars 4.1 Therapeutic indications Previously untreated chronic lymphocytic leukaemia (CLL) Arzerra in combination with chlorambucil or bendamustine is indicated for the treatment of adult patients with CLL who have not received prior therapy and who are not eligible for fludarabine-based therapy. See section 5.1 for further information. Relapsed CLL Arzerra is indicated in combination with fludarabine and cyclophosphamide for the treatment of adult patients with relapsed CLL. See section 5.1 for further information. Refractory CLL Arzerra is indicated for the treatment of CLL in adult patients who are refractory to fludarabine and alemtuzumab. See section 5.1 for further information. 4.2 Posology and method of administration Arzerra should be administered under the supervision of a physician experienced in the use of cancer therapy and in an environment where full resuscitation facilities are immediately available. Monitoring Patients should be closely monitored during adminis Pročitajte cijeli dokument