Xyntha Powder and Solvent for Solution for Injection 250iu

Valsts: Singapūra

Valoda: angļu

Klimata pārmaiņas: HSA (Health Sciences Authority)

Aktīvā sastāvdaļa:

Moroctocog alfa (AF-CC)

Pieejams no:

PFIZER PRIVATE LIMITED

ATĶ kods:

B02BD02

Deva:

250IU/vial

Zāļu forma:

INJECTION, POWDER, FOR SOLUTION

Kompozīcija:

Moroctocog alfa (AF-CC) 250IU/vial

Ievadīšanas:

INTRAVENOUS

Receptes veids:

Prescription Only

Ražojis:

Vetter Pharma-Fertigung GmbH & Co. KG (Pre-filled Syringe Diluent.)

Autorizācija statuss:

ACTIVE

Autorizācija datums:

2010-04-28

Lietošanas instrukcija

MRP COMPONENT DESCRIPTION:
COMPONENT
PACKAGING PLANT
ITEM CODE
PHARMA CODE
BARCODE NO.
JOB NO.
PASS NO.
DATE LAST MODIFIED
LITERATURA XYNTHA MY/SG
PATIENT LEAFLET (Front)
ALGETE
PAA009563
87
N/A
262012A04
4
06 Apr 10
Profile
Black
TINT VALUES
BLACK - 50%
BLACK - 48%
BLACK - 40%
BLACK - 36%
BLACK - 30%
BLACK - 29%
BLACK - 24%
BLACK - 20%
BLACK - 16%
BLACK - 10%
TEXT SIZE
THE BODY TEXT
ON THIS A/W IS AT:
8.0 PT
THE SMALLEST TEXT
ON THIS A/W IS AT:
4.7 PT
FRONT
Non printable area
Bar code (Laetus) - High 5 mm
Bar code
(Laetus)
DIMENSION: 575 X 350 MM    (FOLDED:   115 X 58,3 MM)
Code material - ALGETE
(Font: Helvetica,  Size: 7)
PAA000000
Read Directio
n
PATIENT INFORMATION LEAFLET 
XYNTHA 
™
 (
ZIN-tha) 
[ANTIHEMOPHILIC FACTOR (RECOMBINANT), PLASMA/ALBUMIN-FREE]
Please read this Patient Information carefully before using XYNTHA and each time you get a refill. 
There may be new information. This leaflet does not take the place of talking with your doctor about 
your medical problems or your treatment. 
WHAT IS XYNTHA? 
XYNTHA is an injectable medicine that is used to help control and prevent bleeding in people with 
hemophilia A. Hemophilia A is also called classic hemophilia. 
XYNTHA is not used to treat von Willebrand’s disease. 
DOSAGE STRENGTHS:
XYNTHA is supplied as white to off-white powder in the following dosages:
•
250 IU (International Units)
•
500 IU (International Units)
•
1000 IU (International Units)
•
2000 IU (International Units)
WHAT SHOULD I TELL MY DOCTOR BEFORE USING XYNTHA AND WHEN SHOULD XYNTHA NOT BE USED? 
Tell your doctor about all of your medical conditions, including if you: 
•
are pregnant or planning to become pregnant. It is not known if XYNTHA
may harm your
unborn baby. 
•
are breastfeeding. It is not known if XYNTHA passes into your milk and
if it can harm your
baby. 
Tell your doctor and pharmacist about all 

Produkta apraksts

1
NAME OF THE MEDICINAL PRODUCT
XYNTHA
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
XYNTHA is supplied as a white to off-white powder in the following
dosages:
•
250 IU
•
500 IU
•
1000 IU
•
2000 IU
3
PHARMACEUTICAL FORM
Powder and solvent for solution for intravenous (IV) injection.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
4.1.1
CONTROL OF BLEEDING EPISODES IN HEMOPHILIA A
XYNTHA Antihemophilic Factor (Recombinant), Plasma/Albumin-Free is
indicated for the
control and prevention of bleeding episodes in patients with
hemophilia A (congenital factor
VIII deficiency or classic hemophilia).
4.1.2
ROUTINE AND SURGICAL PROPHYLAXIS IN PATIENTS WITH HEMOPHILIA A
XYNTHA Antihemophilic Factor (Recombinant), Plasma/Albumin-Free is
indicated for
routine and surgical prophylaxis in patients with hemophilia A.
XYNTHA is appropriate for use in children of all ages, including
newborns.
XYNTHA does not contain von Willebrand factor, and therefore is not
indicated in patients
with von Willebrand's disease.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
FOR INTRAVENOUS USE AFTER RECONSTITUTION
•
Treatment with XYNTHA Antihemophilic Factor (Recombinant),
Plasma/Albumin-Free should be initiated under the supervision of a
physician
experienced in the treatment of hemophilia A.
•
Dosage and duration of treatment depend on the severity of the factor
VIII deficiency,
the location and extent of bleeding, and the patient's clinical
condition. Doses
administered should be titrated to the patient's clinical response. In
the presence of an
inhibitor, higher doses may be required.
•
One International Unit (IU) of factor VIII activity corresponds
approximately to the
quantity of factor VIII in one milliliter (mL) of normal human plasma.
The calculation
of the required dosage of factor VIII is based upon the empirical
finding that, on
average, 1 IU of factor VIII per kg body weight raises the plasma
factor VIII activity
by approximately 2 IU/dL. The required dosage is determined using the
following
formula:
The expected _in vivo