Pomolide

Negara: Selandia Baru

Bahasa: Inggris

Sumber: Medsafe (Medicines Safety Authority)

Bahan aktif:

Pomalidomide 3mg

Tersedia dari:

Juno Pharmaceuticals NZ Limited

Dosis:

3 mg

Bentuk farmasi:

Capsule

Komposisi:

Active: Pomalidomide 3mg Excipient: Croscarmellose sodium Gelatin Indigo carmine   Iron oxide yellow Mannitol Purified water Sodium stearyl fumarate Starch TekPrint white SW-0012   Titanium dioxide  

Jenis Resep:

Prescription

Indikasi Terapi:

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.

Ringkasan produk:

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

Tanggal Otorisasi:

2022-11-09

Selebaran informasi

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

Karakteristik produk

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