Land: Nieuw-Zeeland
Taal: Engels
Bron: Medsafe (Medicines Safety Authority)
Pomalidomide 2mg;
Celgene Limited
Pomalidomide 2 mg
2 mg
Capsule
Active: Pomalidomide 2mg Excipient: Erythrosine Gelatin Indigo carmine Iron oxide yellow Mannitol Pregelatinised maize starch Sodium stearyl fumarate Titanium dioxide
Prescription
Lonza AG
Pomalidomide, in combination with dexamethasone, is indicated for the treatment of patients with relapsed and refractory multiple myeloma who have received at least two prior treatment regimens, including both lenalidomide and bortezomib, and have demonstrated disease progression on the last therapy
Package - Contents - Shelf Life: Blister pack, PVC/PCTFE (Aclar)/ Al in printed carton - 21 capsules - 48 months from date of manufacture stored at or below 25°C
2014-09-08
Pomalyst ® (pomalidomide) capsules – NZ CMI Celgene V1.7.0 – 29 October 2020 1 NEW ZEALAND CONSUMER MEDICINE INFORMATION POMALYST ® (POMALIDOMIDE) CAPSULES WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Pomalyst. 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 Pomalyst 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 POMALYST IS USED FOR Pomalyst contains an active substance called pomalidomide. Pomalyst belongs to a group of medicines called immunomodulating agents. Pomalyst is used in combination with another medicine called ‘dexamethasone’ (steroid medicine) to treat adult patients diagnosed with Multiple Myeloma (MM) (a cancer of the bone marrow). It is prescribed for patients whose disease has progressed after two prior therapies. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT HOW POMALYST WORKS, OR WHY THIS MEDICINE HAS BEEN PRESCRIBED FOR YOU . Your doctor may have prescribed it for another reason. This medicine is not addictive. Pomalyst will only be prescribed to you by a doctor who has experience in medicines to treat cancers of the blood. Pomalyst ® (pomalidomide) capsules – NZ CMI Celgene V1.7.0 – 29 October 2020 2 BEFORE YOU TAKE POMALYST _WHEN YOU MUST NOT TAKE IT _ DO NOT TAKE POMALYST IF YOU HAVE AN ALLERGY TO POMALIDOMIDE OR ANY OF THE OTHER INGREDIENTS LISTED AT THE END OF THIS LEAFLET. Some of the symptoms of an allergic reaction may include: • shortness of breath, • wheezing or difficulty breathing, • swelling of the face, lips, tongue or other parts of the body, • rash, itching or hives on the skin. IF YOU THINK YOU MAY BE ALLERGIC TO POMALYST, ASK YOUR DOCTOR FOR ADVICE. DO NOT TAKE THIS MEDICINE IF YOU ARE PREGNANT, O Lees het volledige document
POMALYST ® (pomalidomide) capsules – NZ Data Sheet Page 1 Celgene V3.0 – 31 January 2022 (CCDS V12) NEW ZEALAND DATA SHEET TERATOGENIC EFFECTS: POMALYST (POMALIDOMIDE) IS A THALIDOMIDE ANALOGUE. THALIDOMIDE IS A KNOWN HUMAN TERATOGEN THAT CAUSES SEVERE LIFE-THREATENING HUMAN BIRTH DEFECTS. IF POMALIDOMIDE IS TAKEN DURING PREGNANCY, IT MAY CAUSE BIRTH DEFECTS OR DEATH TO AN UNBORN BABY. WOMEN SHOULD BE ADVISED TO AVOID PREGNANCY WHILST TAKING POMALYST (POMALIDOMIDE), DURING DOSE INTERRUPTIONS, AND FOR 4 WEEKS AFTER STOPPING THE MEDICINE. 1 PRODUCT NAME Pomalyst 1 mg capsules. Pomalyst 2 mg capsules. Pomalyst 3 mg capsules. Pomalyst 4 mg capsules. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 1 mg capsule contains 1 mg pomalidomide. Each 2 mg capsule contains 2 mg pomalidomide. Each 3 mg capsule contains 3 mg pomalidomide. Each 4 mg capsule contains 4 mg pomalidomide. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Presentation Pomalyst 1 mg capsules: dark blue/yellow size 3 gelatin capsules marked “POML” in white ink and “1 mg” in black ink. Pomalyst 2 mg capsules: dark blue/orange size 1 gelatin capsules marked “POML 2 mg” in white ink. Pomalyst 3 mg capsules: dark blue/green size 1 gelatin capsules marked “POML 3 mg” in white ink. Pomalyst 4 mg capsules: dark blue/blue size 1 gelatin capsules marked “POML 4 mg” in white ink. Description Pomalidomide is a yellow solid powder. It is practically insoluble in water over the pH range 1.2-6.8 and is slightly soluble (eg. acetone, methylene chloride) to practically insoluble (eg. heptanes, ethanol) in organic solvents. Pomalidomide has a chiral carbon atom and exists as a racemic mixture of the R(+) and S(-) enantiomers. 4 CLINICAL PARTICULARS 4.1 Therapeutic Indications Pomalidomide, in combination with dexamethasone, is indicated for the treatment of patients with relapsed and refractory multiple myeloma who have received at least two prior treatment regimens, including both lenalidomide and bortezomib, and have demo Lees het volledige document