Xyntha 1000 IU Powder and Solvent for Solution for Injection

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

MOROCTOCOG ALFA

Boleh didapati daripada:

PFIZER (MALAYSIA) SDN. BHD.

INN (Nama Antarabangsa):

MOROCTOCOG ALFA

Unit dalam pakej:

4 ml 1 Units; 4 ml 1 Units

Dikeluarkan oleh:

WYETH FARMA, S.A

Risalah maklumat

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
XYNTHA
®
POWDER AND SOLVENT FOR
SOLUTION FOR INJECTION
Moroctocog alfa (250 IU, 500 IU, 1000 IU or 2000 IU)Xyntha
1
WHAT IS IN THIS LEAFLET
1.
What XYNTHA is used for
2.
How XYNTHA works
3.
Before you use XYNTHA
4.
How to use XYNTHA
5.
While you are using it
6.
Side Effects
7.
Storage and Disposal of XYNTHA
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10. Date of Revision
11. Serial Number
WHAT XYNTHA IS USED FOR
XYNTHA is an injectable medicine that
is used to help control and reduce
bleeding in people with hemophilia A (a
bleeding disorder in which the blood does
not clot properly).
XYNTHA is also used after surgery.
XYNTHA is not used to treat von
Willebrand’s disease (A bleeding
disorder caused by low levels of clotting
protein in the blood).
XYNTHA is appropriate for use in
children of all ages, including newborns.
HOW XYNTHA WORKS
XYNTHA temporarily replaces the
missing clotting factor VIII that is needed
for effective bleeding stoppage and
repairing the damage of injury.
BEFORE YOU USE XYNTHA
-
_When you must not use it_
Do not take XYNTHA
-
if you are hypersensitive (allergic) to
XYNTHA or to any of the other
ingredients of the medicine.
_Pregnancy and lactation_
Consult your doctor if you are pregnant,
trying to get pregnant or think you may
be pregnant.
It is not known if XYNTHA may harm
your unborn baby or passes into your
milk and if it can harm your baby.
Do not take XYNTHA if you are breast-
feeding. Ask your doctor or pharmacist
for advice before taking any medicine.
-
_Before you start to use it_
Talk to your doctor, pharmacist or
nurse before taking XYNTHA:
-
if you have a symptoms of allergic
reaction like rash with itching, chest
tightness, wheezing, low blood
pressure.
Discontinue XYNTHA if allergic
symptoms occur and administer
appropriate emergency treatment.
-
_Taking other medicines_
Tell your doctor if you are taking any
other medicines, including any that you
buy without a prescription from a
pharmacy, superma

Ciri produk

Pfizer Confidential
CLD T itle
: Moroctocog alfa (Xyntha)
CLD Date
: 21 27 August March 20210
Country
: Malaysia
Reference Document
: USPI Dated 14 August 2020
Reason for change
:
PfLEET
2021-0068668
(D): Addition of Routine Prophylaxis
indication2016-0022456 (D): PLLR Conversion per FDA PLLR
: PfLEET 2018-0043970 (D): T he moroctocog alfa (AF-CC) CDS is being
revised to provide
additional information based on the completion of study B1831001
(#313) (an open label clinical
study evaluating efficacy, safety and PK of 2 prophylaxis treatment
regimens in children).
Pfizer Confidential
1
XYNTHA
®
MOROCTOCOG ALFA
1. NAME O F THE MEDIC INAL PRO DUC T
XYNT HA 250 IU powder and solvent for solution for injection
XYNT HA 500 IU powder and solvent for solution for injection
XYNT HA 1000 IU powder and solvent for solution for injection
XYNT HA 2000 IU powder and solvent for solution for injection
2. Q UALITATIVE AND Q UANTITATIVE C O MPO SITIO N
T he active ingredient in XYNT HA, Antihemophilic Factor
(Recombinant), is a recombinant
antihemophilic factor (rAHF), also called coagulation factor VIII,
which is produced by recombinant
DNA technology. It is secreted by a genetically engineered Chinese
hamster ovary (CHO) cell line.
T he cell line is grown in a chemically defined cell culture medium
that contains recombinant insulin ,
but does not contain any materials derived from human or animal
sources.
T he rAHF in XYNTHA is a purified glycoprotein, with an approximate
molecular mass of 170 kDa
consisting of 1,438 amino acids, which does not contain the B-domain.
The amino acid sequence of
the rAHF is comparable to the 90 + 80 kDa form of human coagulation
factor VIII.
T he purification process uses a series of chromatography steps, one
of which is based on affinity
chromatography using a patented synthetic peptide affinity ligand. T
he process also includes a
solvent-detergent viral inactivation step and a virus-retaining
nanofiltration step.
T he potency expressed in International Units (IU) is determined using
the chromog