Valsts: Jaunzēlande
Valoda: angļu
Klimata pārmaiņas: Medsafe (Medicines Safety Authority)
Lenalidomide 2.5mg
Te Arai BioFarma Limited
2.5 mg
Capsule
Active: Lenalidomide 2.5mg Excipient: Allura red AC Brilliant blue FCF Croscarmellose sodium Erythrosine Gelatin Iron oxide red Iron oxide yellow Lactose Magnesium stearate Microcrystalline cellulose Titanium dioxide
Prescription
Lenalidomide Te Arai is indicated for treatment of patients with transfusion-dependent anaemia due to low- or intermediate-1 risk myelodysplastic syndromes associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities.
Package - Contents - Shelf Life: Blister pack, PVC/ACLAR/Al in cardboard carton - 14 capsules - 36 months from date of manufacture stored at or below 25°C - Blister pack, PVC/ACLAR/Al in cardboard carton - 21 capsules - 36 months from date of manufacture stored at or below 25°C - Blister pack, PVC/ACLAR/Al in cardboard carton - 28 capsules - 36 months from date of manufacture stored at or below 25°C
2017-07-11
Lenalidomide Te Arai 1 LENALIDOMIDE TE ARAI _(lenalidomide) _ NEW ZEALAND CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Lenalidomide Te Arai. 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 taking Lenalidomide Te Arai against the benefits this medicine is expected to have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT LENALIDOMIDE TE ARAI IS USED FOR Lenalidomide Te Arai contains an active substance called lenalidomide. Lenalidomide Te Arai belongs to a group of medicines called immunomodulating agents that work by acting on the cells involved in the body's immune system. The immune system is part of the body's defence which helps to fight illness and infection. Treatment of Multiple Myeloma Multiple myeloma (MM) is a cancer of the bone marrow. • Lenalidomide Te Arai is used to treat adult patients who have been diagnosed with newly diagnosed Multiple Myeloma (NDMM) and who have undergone a stem cell transplant. • Lenalidomide Te Arai is used in combination with another medicine called dexamethasone to treat adult NDMM patients who are not eligible for stem cell transplantation. • Lenalidomide Te Arai is also used in combination with dexamethasone to treat adult MM patients whose disease has progressed after one therapy. Treatment of Myelodysplastic Syndromes Lenalidomide Te Arai is also used to treat patients who have conditions called myelodysplastic syndromes (MDS) in whom the bone marrow does not produce enough mature blood cells. This causes a lack of healthy blood cells in the body. There are different types of MDS. Lenalidomide Te Arai is approved to treat a type of MDS where part of chromosome 5 is missing. This type of MDS is known as deletion 5q MDS (or 5q minus). Patients wit Izlasiet visu dokumentu
Page 1 of 36 Lenalidomide Te Arai Data Sheet v 2.0 August 2020 NEW ZEALAND DATA SHEET 1 PRODUCT NAME Lenalidomide Te Arai 2.5 mg capsules Lenalidomide Te Arai 5 mg capsules Lenalidomide Te Arai 7.5 mg capsules Lenalidomide Te Arai 10 mg capsules Lenalidomide Te Arai 15 mg capsules Lenalidomide Te Arai 20 mg capsules Lenalidomide Te Arai 25 mg capsules 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 2.5 mg capsule contains 2.5 mg lenalidomide. Each 5 mg capsule contains 5 mg lenalidomide. Each 7.5 mg capsule contains 7.5 mg lenalidomide. Each 10 mg capsule contains 10 mg lenalidomide. Each 15 mg capsule contains 15 mg lenalidomide. Each 20 mg capsule contains 20 mg lenalidomide. Each 25 mg capsule contains 25 mg lenalidomide. For the full list of excipients, see section 6.1. Lenalidomide Te Arai capsules contain lactose. 3 PHARMACEUTICAL FORM Presentation Lenalidomide Te Arai 2.5 mg capsules: A dark blue opaque cap/ light orange opaque body, capsule shell size No. 4 imprinted in black ink with “LP” on the cap and “637” on the body and filled with white powder. Lenalidomide Te Arai 5 mg capsules: A green opaque cap/ light brown opaque body, capsule shell size No. 2 imprinted in black ink with “LP” on the cap and “638” on the body and filled with white powder. Lenalidomide Te Arai 7.5 mg hard capsules: A violet opaque cap/ pink opaque body, capsule shell size No. 1 imprinted in black ink with “LP” on the cap and “643” on the body and filled with white powder. Lenalidomide Te Arai 10 mg capsules: A yellow opaque cap/ gray opaque body, capsule shell size No. 0 imprinted in black ink with “LP” on the cap and “639” on the body and filled with white powder. Lenalidomide Te Arai 15 mg capsules: A brown opaque cap/ gray opaque body, capsule shell size No. 2 imprinted in black ink with “LP” on the cap and “640” on the body and filled with white powder. Lenalidomide Te Arai 20 mg capsules: A dark red opaque cap/ light gray opaque body, capsule shell size No. 1 imprinted in black ink wi Izlasiet visu dokumentu