Lenalidomide Viatris

Krajina: Nový Zéland

Jazyk: angličtina

Zdroj: Medsafe (Medicines Safety Authority)

Aktívna zložka:

Lenalidomide 7.5mg

Dostupné z:

Viatris Limited

Dávkovanie:

7.5 mg

Forma lieku:

Capsule

Zloženie:

Active: Lenalidomide 7.5mg Excipient: Colloidal silicon dioxide Croscarmellose sodium Gelatin   Iron oxide black Iron oxide yellow Microcrystalline cellulose Sodium stearyl fumarate Starch TekPrint black SW-9008 Titanium dioxide  

Typ predpisu:

Prescription

Terapeutické indikácie:

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

Prehľad produktov:

Package - Contents - Shelf Life: Blister pack, PVC / PCTFE (Aclar) / Aluminium within cardboard carton - 21 capsules - 36 months from date of manufacture stored at or below 25°C

Dátum Autorizácia:

2021-11-30

Príbalový leták

Page 1 of 6
NEW ZEALAND CONSUMER MEDICINE INFORMATION
LENALIDOMIDE VIATRIS
_LENALIDOMIDE CAPSULES 2.5 MG, 5 MG, 7.5 MG, 10 MG, 15 MG, 20 MG, 25
MG_
WHAT IS IN THIS LEAFLET
Please read this leaflet carefully
before you start taking
Lenalidomide Viatris.
This leaflet answers some common
questions about Lenalidomide
Viatris.
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
Viatris against the benefits they
expect it will 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
VIATRIS IS USED FOR
Lenalidomide Viatris contains an
active substance called
lenalidomide. It 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 Viatris 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 Viatris is used
in combination with another
medicine called
dexamethasone to treat adult
NDMM patients who are not
eligible for stem cell
transplantation.
•
Lenalidomide Viatris is also
used in combination with
dexamethasone to treat
adult MM patients whose
disease has progressed
after one therapy.
_TREATMENT OF MYELODYSPLASTIC _
_SYNDROMES_
Lenalidomide Viatris 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 Viatris is approved to
treat a type of MDS where

Súhrn charakteristických

Page 1 of 35
NEW ZEALAND DATA SHEET
LENALIDOMIDE VIATRIS
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 MEDICINE.
1.
PRODUCT NAME
Lenalidomide Viatris 2.5 mg capsules.
Lenalidomide Viatris 5 mg capsules.
Lenalidomide Viatris 7.5 mg capsules.
Lenalidomide Viatris 10 mg capsules.
Lenalidomide Viatris 15 mg capsules.
Lenalidomide Viatris 20 mg capsules.
Lenalidomide Viatris 25 mg capsules.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 2.5 mg capsule contains 2.5 mg of lenalidomide.
Each 5 mg capsule contains 5 mg of lenalidomide.
Each 7.5 mg capsule contains 7.5 mg of lenalidomide.
Each 10 mg capsule contains 10 mg of lenalidomide.
Each 15 mg capsule contains 15 mg of lenalidomide.
Each 20 mg capsule contains 20 mg of lenalidomide.
Each 25 mg capsule contains 25 mg of lenalidomide.
Excipient(s) with known effect: Contains sulfites.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Lenalidomide Viatris 2.5 mg capsule: A No. 4, green opaque cap and
white opaque body, hard-shell
gelatin capsule filled with white to off-white powder. The capsule is
axially printed with MYLAN over
LL 2.5 in black ink on both cap and body.
Lenalidomide Viatris 5 mg capsule: A No. 2, white opaque cap and white
opaque body, hard-shell
gelatin capsule filled with white to off-white powder. The capsule is
axially printed with MYLAN over
LL 5 in black ink on both cap and body.
Lenalidomide Viatris 7.5 mg capsule: A No.2, light grey opaque cap and
white opaque body,
hard-shell gelatin capsule filled with white to off-white powder. The
capsule is axially printed with
MYLAN over LL 7.5 in black ink on both cap and body.
Page 2 of 35
Lenalidomide Viatris 10 mg capsule: A No.