מדינה: ניו זילנד
שפה: אנגלית
מקור: Medsafe (Medicines Safety Authority)
Pomalidomide 4mg
Juno Pharmaceuticals NZ Limited
4 mg
Capsule
Active: Pomalidomide 4mg Excipient: Croscarmellose sodium Gelatin Indigo carmine Mannitol Purified water Sodium stearyl fumarate Starch TekPrint white SW-0012 Titanium dioxide
Prescription
Pomolide, 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) / Aluminium in outer carton - 14 capsules - 36 months from date of manufacture stored at or below 25°C - Blister pack, PVC/PCTFE (Aclar) / Aluminium in outer carton - 21 capsules - 36 months from date of manufacture stored at or below 25°C
2022-11-09
Pomolide capsules 1 POMOLIDE CAPSULES CONSUMER MEDICINE INFORMATION (CMI) SUMMARY The full CMI on the next page has more details. If you are worried about taking this medicine, speak to your doctor or pharmacist. WARNING: Important safety information is provided in a boxed warning in the full CMI. Read before taking this medicine. 1. WHY AM I TAKING POMOLIDE? Pomolide contains the active ingredient pomalidomide. Pomolide 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. For more information, see Section 1. Why am I taking Pomolide? in the full CMI. 2. WHAT SHOULD I KNOW BEFORE I TAKE POMOLIDE? Do not use if you have ever had an allergic reaction to pomalidomide or any of the ingredients listed at the end of the CMI. TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME PREGNANT OR ARE BREASTFEEDING. For more information, see Section 2. What should I know before I take Pomolide? in the full CMI. 3. WHAT IF I AM TAKING OTHER MEDICINES? Some medicines may interfere with Pomolide and affect how it works. A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI. 4. HOW DO I TAKE POMOLIDE? Your doctor will tell you how much Pomolide to take and for how long you will need to take it, will monitor your progress and may adjust your dose or stop your treatment based on the results of your blood tests and on your general condition. Follow the instructions provided and use Pomolide until your doctor tells you to stop. Swallow the capsules whole with a full glass of water, once a day as directed by your doctor. Pomolide can be taken with or without food. Do not open, break or chew the capsules. If powder from the capsules contact the skin, wash the skin immediately and thoroughly with soap and water. If pomali קרא את המסמך השלם
Pomolide New Zealand datasheet POMOLIDE (pomalidomide) capsules Version 1.0 1 NEW ZEALAND DATA SHEET TERATOGENIC EFFECTS: POMALIDOMIDE (POMOLIDE) 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 POMOLIDE (POMALIDOMIDE), DURING DOSE INTERRUPTIONS, AND FOR 4 WEEKS AFTER STOPPING THE MEDICINE. 1 PRODUCT NAME Pomolide 1 mg capsules. Pomolide 2 mg capsules. Pomolide 3 mg capsules. Pomolide 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 Pomolide (pomalidomide) 1 mg capsules: dark blue cap and a yellow body printed with black ink on the body of the hard gelatin capsules. Pomolide (pomalidomide) 2 mg capsules: dark blue cap and a orange body printed with white ink on the body of the hard gelatin capsules. Pomolide (pomalidomide) 3 mg capsules: dark blue cap and a green body printed with white ink on the body of the hard gelatin capsules. Pomolide (pomalidomide) 4 mg capsules: dark blue cap and a blue body printed with white ink on the body of the hard gelatin capsules. 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 trea קרא את המסמך השלם