AFSTYLA 1000IU powder and solvent for solution for injection

Quốc gia: Malaysia

Ngôn ngữ: Tiếng Anh

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

Thành phần hoạt chất:

Lonoctocog alfa

Sẵn có từ:

DKSH MALAYSIA SDN. BHD.

INN (Tên quốc tế):

Lonoctocog alfa

Các đơn vị trong gói:

6 ml

Sản xuất bởi:

CSL Behring GmbH

Tờ rơi thông tin

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
_ _
AFSTYLA
®
_ _
Lonoctocog alfa (250IU, 500IU, 1000IU, 2000IU, 3000IU)
1
WHAT IS IN THIS LEAFLET
1.
What AFSTYLA is used for
2.
How AFSTYLA
_ _
works
3.
Before you use AFSTYLA
4.
How to use AFSTYLA
_5._
_ _
While you are using AFSTYLA
_ _
6.
Side effects
7.
Storage
and
Disposal
of
AFSTYLA
8.
Product Description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of revision
11. Serial number
WHAT AFSTYLA IS USED FOR
AFSTYLA is an injectable clotting
(coagulation) factor VIII product that
is
produced
by
recombinant
DNA
technology.
The
active
substance
AFSTYLA is lonoctocog alfa.
AFSTYLA is used to treat, prevent, or
reduce
the
frequency
of
bleeding
episodes in patients with haemophilia
A (inborn factor VIII deficiency) and
can be used for all age groups. It can be
used during surgeries too.
HOW AFSTYLA WORKS
Factor
VIII
is
involved
in
blood
clotting. Lack of this factor means that
blood does not clot as quickly as it
should
so
there
is
an
increased
tendency to bleed. AFSTYLA works
by
replacing
factor
VIII
in
haemophilia A patients to enable their
blood to clot
BEFORE YOU USE AFSTYLA
-
_When you must not use it: _
Do not use AFSTYLA if you have
had
a
life-threatening
allergic
reaction to AFSTYLA, any of its
components or excipients (listed in
section
“Product Description”), or
hamster proteins.
_ _
-
_Before you start to use it _
Talk to
your doctor, pharmacist or
nurse before using AFSTYLA.
•
Allergic
(hypersensitivity)
reactions are possible. The product
contains traces of hamster proteins
(see also When you must not use
it”).
If
symptoms
of
hypersensitivity occur, you should
stop
using
the
medicine
immediately
and
contact
your
doctor. Your doctor should inform
you
of
the
early
signs
of
hypersensitivity
reactions.
These
include
hives,
generalised
skin
rash,
tightness
of
the
chest,
wheezing, fall in blood pressure
and anaphylaxis (a serious allergic
reaction
that
causes
severe
difficulty
in
breathing,
or
dizziness).
•
Because
of
the
risk
of
allerg

Đặc tính sản phẩm

1.
NAME OF THE MEDICINAL PRODUCT
_AFSTYLA_
250IU powder and solvent for solution for injection.
_AFSTYLA_
500IU powder and solvent for solution for injection.
_AFSTYLA_
1000IU powder and solvent for solution for injection.
_AFSTYLA_
2000IU powder and solvent for solution for injection.
_AFSTYLA_
3000IU powder and solvent for solution for injection.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One
vial
contains
nominally
250/500/1000/2000/3000
IU
recombinant,
single
chain
coagulation factor VIII
_ _
(rVIII-SingleChain, INN = lonoctocog alfa).
After reconstitution with 2.5 ml water for injections (250/500/1000
IU) the solution contains
100/200/400 IU/ml of rVIII-SingleChain. When reconstituted with 5 ml
water for injections
(2000/3000 IU) the solution contains 400/600 IU/ml of
rVIII-SingleChain.
The potency (IU) is determined using the European Pharmacopoeia
chromogenic assay. The
specific activity of
_AFSTYLA_
is 7400 - 16000 IU/mg protein.
_AFSTYLA _
is a single chain recombinant factor VIII produced in Chinese hamster
ovary
(CHO) cells. It is a construct where most of the B-domain occurring in
wild-type, full-length
factor VIII and 4 amino acids of the adjacent acidic a3 domain were
removed (amino acids
765 to 1652 of full-length factor VIII).
The newly formed linkage of the heavy and light chain of factor VIII
introduces a new N-
glycosylation site. As the furin cleavage site present in wild type
factor VIII between the B-
domain and the a3 domain was removed,
_AFSTYLA_
is expressed as a single chain factor VIII
molecule.
Excipient with known effect:
Sodium approximately 0.23-0.30 mmol/ml (5.4-7.0 mg/ml).
For the full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Powder and solvent for solution for injection.
White or slightly yellow powder or friable mass and clear, colourless
solvent for solution for
injection.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
_AFSTYLA _
is indicated in adults and pediatrics with hemophilia A (congenital
factor VIII
deficiency) for:
•
Control and prevention of