NovoEight 1000IU Powder and Solvent for Solution for Injection

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

Turoctocog Alfa

Boleh didapati daripada:

NOVO NORDISK PHARMA (MALAYSIA) SDN. BHD.

INN (Nama Antarabangsa):

Turoctocog Alfa

Unit dalam pakej:

1 vial Vials

Dikeluarkan oleh:

Novo Nordisk A/S

Risalah maklumat

NOVOEIGHT
®
_Consumer Medication Information Leaflet (RiMUP)_
250, 500 & 1000 IU
_ _
Turoctocog Alfa (human coagulation factor VIII (rDNA))
______________________________________________________________________________________________
1
WHAT IS IN THIS LEAFLET
1.
What NovoEight
®
is used for
2.
How NovoEight
®
works
3.
Before you use NovoEight
®
4.
How to use NovoEight
®
5.
While you are using it
6.
Side effects
7.
Storage and disposal of
NovoEight
®
8.
Product description
9.
Manufacturer
10.
Product Registration Holder
11.
Date of revision
1. WHAT NOVOEIGHT
® IS USED FOR
NovoEight
®
is
used
to
treat
and
prevent bleeding episodes in patients
with haemophilia A (inborn factor
VIII deficiency) and can be used for
all age groups.
2. HOW NOVOEIGHT
® WORKS
NovoEight
®
contains
the
active
substance
turoctocog
alfa,
human
coagulation factor VIII. Factor VIII
is a protein naturally found in the
blood that helps it to clot.
In
patients
with
haemophilia
A,
factor VIII is missing or not working
properly. NovoEight
®
replaces this
faulty or missing ‘factor VIII’ and
helps blood to form clots at the site
of bleeding.
3. BEFORE YOU USE NOVOEIGHT
®
_- WHEN YOU MUST NOT USE IT _
►If you are allergic to the active
substance
or
to
any
of
the
other
ingredients of this medicine.
►If
you
are
allergic
to
hamster
proteins.
Do not use NovoEight
®
if either of
the above applies to you. If you are
not sure, talk to your doctor before
using this medicine.
_- BEFORE YOU START TO USE IT _
_ _
Talk
to
your
doctor
before
using
NovoEight
®
.
_- TAKING OTHER MEDICINES _
Tell your doctor if you are taking,
have recently taken or might take
any other medicines.
4. HOW TO USE NOVOEIGHT
®
_- HOW MUCH TO USE _
Treatment with NovoEight
®
will be
started
by
a
doctor
who
is
experienced in the care of patients
with haemophilia A. Always use this
medicine exactly as your doctor has
told you. Check with your doctor if
you are not sure.
Your doctor will calculate your dose
for you. This will depend on your
weight
and
what
the
medicin

Ciri produk

NovoEight
®
Professional leaflet EN-Apr-2021_8-9063-00-007-1
Based on EU text: 20200925_EN_N8_05593_ver-13-3
1
1.
NAME OF THE MEDICINAL PRODUCT
NOVOEIGHT
®
250 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
500 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
1000 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each powder vial contains nominally 250, 500 or 1000 IU human
coagulation factor VIII (rDNA),
turoctocog alfa.
After reconstitution NovoEight
®
contains approximately 62.5, 125 or 250 IU/ml of human coagulation
factor VIII (rDNA), turoctocog alfa.
The potency (IU) is determined using the European Pharmacopoeia (Ph.
Eur) chromogenic assay. The
specific activity of NovoEight
®
is approximately 8,300 IU/mg protein.
Turoctocog alfa (human coagulation factor VIII (rDNA)) is a purified
protein that has 1,445 amino acids
with an approximate molecular mass of 166 kDA. It is produced by
recombinant DNA technology in
Chinese hamster ovary (CHO) cells, and prepared without the addition
of any human or animal derived
protein in the cell culture process, purification or final
formulation.
Turoctocog alfa is a B-domain truncated recombinant human coagulation
factor VIII (B-domain consists of
21 amino acids of the wild type B-domain) without any other
modifications in the amino acid sequence.
_Excipient with known effect_
The medicinal product contains 30.5 mg sodium per reconstituted vial.
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.
Clear and colourless solution for injection.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment and prophylaxis of bleeding in patients with haemophilia A
(congenital factor VIII deficiency).
NovoEight
®
can be used for all age groups.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Treatment should be under the supervision of a doctor experienced in
the treatment of haemophilia.
Treatment monitoring
During th