Valsts: Austrālija
Valoda: angļu
Klimata pārmaiņas: Department of Health (Therapeutic Goods Administration)
pomalidomide, Quantity: 4 mg
Juno Pharmaceuticals Pty Ltd
Capsule, hard
Excipient Ingredients: pregelatinised starch; mannitol; sodium stearylfumarate; croscarmellose sodium; titanium dioxide; indigo carmine; purified water; Gelatin; propylene glycol; butan-1-ol; isopropyl alcohol; Shellac; ethanol absolute; ammonia; potassium hydroxide
Oral
14 capsules, 21 capsules
(S4) Prescription Only Medicine
Pomalidomide, in combination with bortezomib and dexamethasone, is indicated for the treatment of patients with relapsed or refractory multiple myeloma who have received at least one prior treatment regimen including lenalidomide.,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.
Visual Identification: Size 2 hard gelatin capsules with dark blue cap and a blue body printed with 'NAT' in white ink on the cap and '4 mg' in white ink on the body of the capsules.; Container Type: Blister Pack; Container Material: PVC/PCTFE (Aclar)/Al; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius
Registered
2021-05-18
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. Pomolide is also used in combination with dexamethasone and another medicine called 'bortezomib' to treat adult MM patients whose disease has progressed after one therapy. 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 Izlasiet visu dokumentu
Pomolide Australian product information POMOLIDE (pomalidomide) capsules – Product Information 1 AUSTRALIAN PRODUCT INFORMATION – POMOLIDE (POMALIDOMIDE) CAPSULES TERATOGENIC EFFECTS: POMOLIDE (POMOLIDOMIDE) 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 NAME OF THE MEDICINE Australian Approved Name: pomalidomide 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 Size 4 hard gelatin capsules with dark blue cap and a yellow body printed with 'NAT' in white ink on the cap and '1 mg' in black ink on the body of the capsules. Each 1 mg capsule contains 1 mg of pomalidomide. Pomolide (pomalidomide) 2 mg capsules: Size 2 hard gelatin capsules with dark blue cap and an orange body printed with 'NAT' in white ink on the cap and '2 mg' in white ink on the body of the capsules. Each 2 mg capsule contains 2 mg of pomalidomide. Pomolide (pomalidomide) 3 mg capsules: Size 2 hard gelatin capsules with dark blue cap and a green body printed with 'NAT' in white ink on the cap and '3 mg' in white ink on the body of the capsules. Each 3 mg capsule contains 3 mg of pomalidomide. Pomolide (pomalidomide) 4 mg capsules: Size 2 hard gelatin capsules with dark blue cap and a blue body printed with 'NAT' in white ink on the cap and '4 mg' in white ink on the body of the capsules. Each 4 mg capsule contains 4 mg of pomalidomide. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Pomolide, in combination with bortezomib and dexamet Izlasiet visu dokumentu