CIPLA LENALIDOMIDE lenalidomide 5 mg capsule blister pack

Nazione: Australia

Lingua: inglese

Fonte: Department of Health (Therapeutic Goods Administration)

Principio attivo:

lenalidomide, Quantity: 5 mg

Commercializzato da:

Cipla Australia Pty Ltd

Forma farmaceutica:

Capsule

Composizione:

Excipient Ingredients: lactose; microcrystalline cellulose; croscarmellose sodium; magnesium stearate; titanium dioxide; sorbitan monolaurate; potable water; Gelatin; sodium lauryl sulfate

Via di somministrazione:

Oral

Confezione:

14, 28, 21

Tipo di ricetta:

(S4) Prescription Only Medicine

Indicazioni terapeutiche:

Multiple Myeloma (MM) Lenalidomide is indicated for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplantation. Lenalidomide is indicated for the maintenance treatment of patients with newly diagnosed multiple myeloma who have undergone autologous stem cell transplantation. Lenalidomide in combination with dexamethasone is indicated for the treatment of multiple myeloma patients whose disease has progressed after one therapy.,Myelodysplastic Syndromes (MDS) Lenalidomide 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.

Dettagli prodotto:

Visual Identification: White to off white powder filled in size 2 hard gelatin white and white capsule spin printed in black ink with 'Cipla 5 mg' on the cap; Container Type: Blister Pack; Container Material: PVC/PCTFE (Aclar)/Al; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure

Stato dell'autorizzazione:

Registered

Data dell'autorizzazione:

2019-10-08

Foglio illustrativo

Cipla Lenalidomide
1
CIPLA LENALIDOMIDE
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
WARNING: Important safety information is provided in a boxed warning
in the full CMI. Read before using this medicine.
1.
WHY AM I USING CIPLA LENALIDOMIDE?
Cipla Lenalidomide contains the active ingredient lenalidomide. Cipla
Lenalidomide is used for treatment of multiple myeloma
(MM) and myelodysplastic syndromes. For more information, see Section
1. Why am I using Cipla Lenalidomide? in the full
CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE CIPLA LENALIDOMIDE?
Your doctor will have enrolled you in the Cipla Lenalidomide-Pregnancy
Prevention Program to ensure that lenalidomide is
used safely. Do not use if you have ever had an allergic reaction to
lenalidomide 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 use Cipla
Lenalidomide? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Cipla Lenalidomide 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 USE CIPLA LENALIDOMIDE?
•
Your doctor will tell you how much Cipla Lenalidomide to take and for
how long you will need to take it.
•
For the treatment of new diagnosed multiple myeloma (NDMM) after a
stem cell transplant, the usual starting dose is 10
mg once daily.
•
For the treatment of myelodysplastic syndromes, the recommended
starting dose is 10 mg once a day for 21 days of a 28-
Day cycle.
More instructions can be found in Section 4. How do I use Cipla
Lenalidomide? in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING CIPLA LENALIDOMIDE?
THINGS YOU SHOULD DO
•
Remind any doctor, dentist or pharmacist when yo

Scheda tecnica

AUSTRALIAN PRODUCT INFORMATION
CIPLA LENALIDOMIDE (LENALIDOMIDE) CAPSULES
TERATOGENIC EFFECTS:
Lenalidomide is structurally related to thalidomide. Thalidomide is a
known human teratogen that
causes severe life-threatening human birth defects. If lenalidomide is
taken during pregnancy, it
may cause birth defects or death to an unborn baby. Women should be
advised to avoid pregnancy
whilst taking lenalidomide, during dose interruptions, and for 4 weeks
after stopping the
medication.
1.
NAME OF THE MEDICINE
Australian approved name: lenalidomide
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5 mg capsule contains 5 mg lenalidomide and 147 mg of lactose.
Each 10 mg capsule contains 10 mg lenalidomide and 294 mg of lactose.
Each 15 mg capsule contains 15 mg lenalidomide and 120 mg of lactose.
Each 20 mg capsule contains 20 mg lenalidomide and 160 mg of lactose.
Each 25 mg capsule contains 25 mg lenalidomide and 200 mg of lactose.
For the full list of excipients, see section 6.1 (List of excipients).
Description
Lenalidomide is an off-white to pale yellow coloured crystalline
anhydrous powder, with a melting point
between 263.5ºC and 264.3ºC. Lenalidomide is freely soluble in
dimethyl formamide, practically
insoluble in water, ethanol, diethyl ether.
Lenalidomide has an asymmetric carbon atom and can therefore exist as
the optically active forms S(-)
and R(+). Lenalidomide is produced as a racemic mixture with a net
optical rotation of zero.
3.
PHARMACEUTICAL FORM
CIPLA LENALIDOMIDE (lenalidomide) 5 mg capsules are off white to pale
yellow coloured
crystalline anhydrous powder filled in size ‘2’ hard gelatin white
and white capsule spin printed in black
ink with ‘Cipla 5 mg’ on the cap.
CIPLA LENALIDOMIDE (lenalidomide) 10 mg capsules are off white to pale
yellow coloured
crystalline anhydrous powder filled in size ‘0’ hard gelatin blue
green and pale yellow capsule spin
printed in black ink with ‘Cipla 10 mg’ on the cap.
CIPLA LENALIDOMIDE (lenalidomide) 15 mg capsules are off white to pale
yellow