Lenalidomide Te Arai

Valsts: Jaunzēlande

Valoda: angļu

Klimata pārmaiņas: Medsafe (Medicines Safety Authority)

Aktīvā sastāvdaļa:

Lenalidomide 7.5mg

Pieejams no:

Te Arai BioFarma Limited

Deva:

7.5 mg

Zāļu forma:

Capsule

Kompozīcija:

Active: Lenalidomide 7.5mg Excipient: Brilliant blue FCF Croscarmellose sodium Erythrosine Gelatin Lactose Magnesium stearate Microcrystalline cellulose Sunset yellow FCF Titanium dioxide

Receptes veids:

Prescription

Ārstēšanas norādes:

Lenalidomide Te Arai 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.

Produktu pārskats:

Package - Contents - Shelf Life: Blister pack, PVC/ACLAR/Al in cardboard carton - 14 capsules - 36 months from date of manufacture stored at or below 25°C - Blister pack, PVC/ACLAR/Al in cardboard carton - 21 capsules - 36 months from date of manufacture stored at or below 25°C - Blister pack, PVC/ACLAR/Al in cardboard carton - 28 capsules - 36 months from date of manufacture stored at or below 25°C

Autorizācija datums:

2017-07-11

Lietošanas instrukcija

Lenalidomide Te Arai
1
LENALIDOMIDE TE ARAI
_(lenalidomide) _
NEW ZEALAND CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS
LEAFLET
This leaflet answers some common
questions about Lenalidomide Te
Arai. 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 Lenalidomide
Te Arai 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
LENALIDOMIDE
TE ARAI IS USED FOR
Lenalidomide Te Arai contains an
active substance called lenalidomide.
Lenalidomide Te Arai
belongs to a group of medicines
called immunomodulating agents
that work by acting on the cells
involved in the body's immune
system. The immune system is part
of the body's defence which helps to
fight illness and infection.
Treatment of Multiple Myeloma
Multiple myeloma (MM) is a cancer
of the bone marrow.
•
Lenalidomide Te Arai is used
to treat adult patients who
have been diagnosed with
newly diagnosed Multiple
Myeloma (NDMM) and who
have undergone a stem cell
transplant.
•
Lenalidomide Te Arai is used in
combination with another
medicine called dexamethasone
to treat adult NDMM patients
who are not eligible for stem
cell transplantation.
•
Lenalidomide Te Arai is also
used in combination with
dexamethasone to treat adult
MM patients whose disease has
progressed after one therapy.
Treatment of Myelodysplastic
Syndromes
Lenalidomide Te Arai is also used to
treat patients who have conditions
called myelodysplastic syndromes
(MDS) in whom the bone marrow
does not produce enough mature
blood cells. This causes a lack of
healthy blood cells in the body.
There are different types of MDS.
Lenalidomide Te Arai is approved to
treat a type of MDS where part of
chromosome 5 is missing. This type
of MDS is known as deletion 5q
MDS (or 5q minus). Patients wit

Produkta apraksts

Page
1
of
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Lenalidomide Te Arai Data Sheet v 2.0 August 2020
NEW ZEALAND DATA SHEET
1
PRODUCT NAME
Lenalidomide Te Arai 2.5 mg capsules
Lenalidomide Te Arai 5 mg capsules
Lenalidomide Te Arai 7.5 mg capsules
Lenalidomide Te Arai 10 mg capsules
Lenalidomide Te Arai 15 mg capsules
Lenalidomide Te Arai 20 mg capsules
Lenalidomide Te Arai 25 mg capsules
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 2.5 mg capsule contains 2.5 mg lenalidomide.
Each 5 mg capsule contains 5 mg lenalidomide.
Each 7.5 mg capsule contains 7.5 mg lenalidomide.
Each 10 mg capsule contains 10 mg lenalidomide.
Each 15 mg capsule contains 15 mg lenalidomide.
Each 20 mg capsule contains 20 mg lenalidomide.
Each 25 mg capsule contains 25 mg lenalidomide.
For the full list of excipients, see section 6.1.
Lenalidomide Te Arai capsules contain lactose.
3
PHARMACEUTICAL FORM
Presentation
Lenalidomide Te Arai 2.5 mg capsules: A dark blue opaque cap/ light
orange opaque body, capsule shell
size No. 4 imprinted in black ink with “LP” on the cap and
“637” on the body and filled with white
powder.
Lenalidomide Te Arai 5 mg capsules: A green opaque cap/ light brown
opaque body, capsule shell size
No. 2 imprinted in black ink with “LP” on the cap and “638” on
the body and filled with white powder.
Lenalidomide Te Arai 7.5 mg hard capsules: A violet opaque cap/ pink
opaque body, capsule shell size
No. 1 imprinted in black ink with “LP” on the cap and “643” on
the body and filled with white powder.
Lenalidomide Te Arai 10 mg capsules: A yellow opaque cap/ gray opaque
body, capsule shell size No.
0 imprinted in black ink with “LP” on the cap and “639” on the
body and filled with white powder.
Lenalidomide Te Arai 15 mg capsules: A brown opaque cap/ gray opaque
body, capsule shell size No.
2 imprinted in black ink with “LP” on the cap and “640” on the
body and filled with white powder.
Lenalidomide Te Arai 20 mg capsules: A dark red opaque cap/ light gray
opaque body, capsule shell
size No. 1 imprinted in black ink wi