Scemblix 40mg film-coated tablet

Ülke: Malezya

Dil: İngilizce

Kaynak: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Aktif bileşen:

Asciminib hydrochloride

Mevcut itibaren:

NOVARTIS CORPORATION (MALAYSIA) SDN. BHD.

INN (International Adı):

Asciminib hydrochloride

Paketteki üniteler:

60 Tablets

Tarafından üretildi:

NOVARTIS PHARMA STEIN AG

Bilgilendirme broşürü

SCEMBLIX
®
FILM-COATED TABLETS
Asciminib (20mg, 40mg)
1
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
WHAT IS IN THIS LEAFLET
1.
What Scemblix is used for
2.
How Scemblix works
3.
Before you use Scemblix
4.
How to use Scemblix
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of Scemblix
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
11.
Serial number
WHAT SCEMBLIX IS USED FOR
Scemblix is a cancer medicine used to
treat adults with a type of blood cancer
(leukaemia) called Philadelphia
chromosome-positive chronic myeloid
leukaemia in chronic phase (Ph+
CML-CP). It is given to patients who
were previously treated with two or more
cancer medicines called tyrosine kinase
inhibitors.
HOW SCEMBLIX WORKS
In Ph+ CML, the body produces large
numbers of abnormal white blood cells.
Scemblix blocks the action of a protein
(BCR::ABL1) that is produced by these
abnormal white blood cells and stops
their division and growth.
If you have any questions about how this
medicine works or why this medicine has
been prescribed for you, ask your doctor
or pharmacist.
BEFORE YOU USE SCEMBLIX
-
When you must not use it
Do not take Scemblix if you are allergic
to asciminib or any of the other
ingredients of this medicine.
CHILDREN AND ADOLESCENTS
Do not give this medicine to children or
adolescents aged under 18 years.
_Pregnancy and lactation _
If you are pregnant or breast-feeding,
think you may be pregnant or are
planning to have a baby, ask your doctor
or pharmacist for advice before taking
this medicine.
Pregnancy
Scemblix may harm your unborn baby. If
you are a woman who could become
pregnant, your doctor will discuss with
you the potential risks of taking it during
pregnancy or breast-feeding.
If you are a woman who could become
pregnant, your doctor may perform a
pregnancy test before starting treatment
with Scemblix.
If you do become pregnant, or think you
may be pregnant, after starting treatment
with Scemblix, tell your doctor straight
away.
Contraceptive advice

Ürün özellikleri

Novartis
15 Dec 2022
Scemblix
®
Malaysia Package Leaflet
2
1.
NAME OF THE MEDICINAL PRODUCT
Scemblix 20 mg film-coated tablets
Scemblix 40 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Scemblix 20 mg film-coated tablets
Each film-coated tablet contains 21.62 mg asciminib hydrochloride,
equivalent to 20 mg asciminib.
_Excipient with known effect_
Each film-coated tablet contains 43 mg lactose monohydrate.
Scemblix 40 mg film-coated tablets
Each film-coated tablet contains 43.24 mg asciminib hydrochloride,
equivalent to 40 mg asciminib.
_Excipient with known effect_
Each film-coated tablet contains 86 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet (tablet).
Scemblix 20 mg film-coated tablets
Pale yellow, unscored, round, biconvex film-coated tablets with
bevelled edges of approximately
6.2 mm diameter, debossed with “Novartis logo” on one side and
“20” on the other side.
Scemblix 40 mg film-coated tablets
Violet white, unscored, round, biconvex film-coated tablets with
bevelled edges of approximately
8.2 mm diameter, debossed with “Novartis logo” on one side and
“40” on the other side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Scemblix is indicated for the treatment of adult patients with
Philadelphia chromosome-positive
chronic myeloid leukaemia in chronic phase (Ph+ CML-CP) previously
treated with two or more
tyrosine kinase inhibitors (see section 5.1).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Treatment should be initiated by a physician experienced in the
diagnosis and treatment of patients
with leukaemia.
Novartis
15 Dec 2022
Scemblix
®
Malaysia Package Leaflet
3
Posology
The recommended dose is 40 mg twice daily at approximately 12-hour
intervals.
_Missed dose_
If a dose is missed by less than 6 hours, it should be taken and the
next dose should be taken as
scheduled.
If a dose is missed by more than approximately 6 hours, it should be
skipped and the next dose should
be taken as scheduled.
_