ADVATE 1500IU POWDER AND SOLVANT FOR SOLUTION FOR INJECTION

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

rFVIII (OCTOCOG ALFA)

Boleh didapati daripada:

Takeda Malaysia Sdn Bhd

INN (Nama Antarabangsa):

rFVIII (OCTOCOG ALFA)

Unit dalam pakej:

5 ml

Dikeluarkan oleh:

Baxalta Belgium Manufacturing S.A.

Risalah maklumat

_ADVATE_ 250, 500, 1000, 1500 IU
OCTOCOG ALFA (RECOMBINANT HUMAN COAGULATION FACTOR VIII)
1
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
WHAT IS IN THIS LEAFLET
1.
What
_ADVATE_
is used for
2.
How
_ADVATE _
works
3.
Before you use
_ADVATE _
4.
How to use
_ADVATE _
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of
_ADVATE _
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT _ADVATE IS_ USED FOR
_ADVATE_
is used for the treatment and
prevention of bleeding in patients of all
age groups with haemophilia A (an
inherited bleeding disorder caused by
lack of factor VIII).
HOW _ADVATE WORKS_
_ADVATE _
contains the active substance
octocog alfa, human coagulation factor
VIII produced by recombinant DNA
technology. Factor VIII is necessary for
the blood to form clots and stop
bleedings. In patients with haemophilia
A (inborn lack of factor VIII), it is
missing or not working properly.
BEFORE YOU USE _ADVATE_
_When you must not use it _
_ _
Do not take
_ADVATE _
if you:
•
are allergic to octocog alfa or
any of the other ingredients of
this medicine. See the end of
this leaflet for a complete list of
ingredients in
_ADVATE._
•
Are allergic to mouse or
hamster proteins.
If you are unsure about this, ask your
doctor.
_Before you start to use it _
Talk to your doctor before using
_ADVATE._
You should tell your doctor if
you have been previously treated with
Factor VIII products, especially if you
developed inhibitors, since there might
be a higher risk that it happens again.
Inhibitors are blocking antibodies against
factor VIII that reduce the efficacy of
_ADVATE_
to prevent or control bleeding.
Development of inhibitors is a known
complication in the treatment of
haemophilia A. If your bleeding is not
controlled with
_ADVATE_
, tell your
doctor immediately.
There is a rare risk that you may
experience an anaphylactic reaction (a
severe, sudden allergic reaction) to
_ADVATE_
. You should be aware of the
early signs of allergic reactions such as
rash, hiv

Ciri produk

Technical Info
Dieline
NA
NA
NA
CODE 3 OF 9
DATAMATRIX CODE
RSS / GS1-128 CODE
BODY TEXT SIZE
8.0 pt
NA
CODE ITF 2/5
511
PHARMACODE
NA
GTIN / EAN-13 CODE
BACK
Black
TECHNICAL SPECIFICATION:
ARTWORK DIMENSIONS/SIZE:
ITEM NUMBER:
FRONT
LE-00-01790
VERSION: 2
PROFILE: 0400374_1_PIL_Drwg
LE0400374
310 x 446 mm
GRAPHICS HOUSE:
SGK Redmond
DATE:
06JUN2020
OPTIONAL: Artwork Approver outside the Shire Management System:
ROLE:
NAME:
SIGNATURE:
DATE:
PANTONE 259 C
Swatch
Swatch
Black
Swatch
Swatch
Swatch
1. NAME OF THE MEDICINAL PRODUCT
ADVATE 1500 IU powder and solvent for solution for injection.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains nominally 1500 IU human coagulation factor VIII
(rDNA), octocog alfa. ADVATE contains approximately 300 IU per ml of
human coagulation factor VIII (rDNA), octocog alfa after
reconstitution.
The potency (International Units) is determined using the European
Pharmacopoeia chromogenic assay. The specific activity of ADVATE
is approximately 4,000‑10,000 IU/mg protein.
Octocog alfa (human coagulation factor VIII (rDNA)) is a purified
protein that has 2332 amino acids. It is produced by recombinant
DNA technology in Chinese hamster ovary (CHO) cells. Prepared
without the addition of any (exogenous) human‑ or animal‑derived
protein in the cell culture process, purification or final
formulation.
Excipients with known effect: 0.45 mmol sodium (10 mg) per vial.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Powder and solvent for solution for injection.
White to off‑white friable powder.
Solvent: Clear and colourless solution.
4. CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment and prophylaxis of bleeding in patients with haemophilia
A (congenital factor VIII deficiency).
ADVATE does not contain von Willebrand Factor and is therefore not
indicated in von Willebrand’s disease.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Treatment should be initiated under the supervision of a physician
experienced in the treatment of haemophilia and wi