HAEMATE P 500 IU FVIII 1200 IU VWF

Krajina: Izrael

Jazyk: angličtina

Zdroj: Ministry of Health

Aktívna zložka:

FACTOR VIII (HUMAN); VON WILLEBRAND FACTOR

Dostupné z:

CSL BEHRING LTD., ISRAEL

ATC kód:

B02BD07

Forma lieku:

POWDER AND SOLVENT FOR SOLUTION FOR INJECTION/INFUSION

Zloženie:

FACTOR VIII (HUMAN) 500 IU / 10 ML; VON WILLEBRAND FACTOR 1200 IU / 10 ML

Spôsob podávania:

I.V

Typ predpisu:

Required

Výrobca:

CSL BEHRING GMBH, GERMANY

Terapeutické skupiny:

COAGULATION FACTOR XIII

Terapeutické oblasti:

COAGULATION FACTOR XIII

Terapeutické indikácie:

Congenital and acquired deficiency of blood clotting factor VIII: severe or moderate haemophilia, prophylaxis during operation, Von Willebrands disease.

Dátum Autorizácia:

2014-02-28

Príbalový leták

העדוה
העדוה
לע
לע
הרמחה
הרמחה
(
(
עדימ
עדימ
ןולעב )תוחיטב
ןולעב )תוחיטב
ל
ל
אפור
אפור
ןכדועמ(
ןכדועמ(
05.2013
05.2013
)
)
ךיראת
19/11/2014
םש
רישכת
תילגנאב
רפסמו
:םושירה
HAEMATE-P 250 I.U. (
113 53 22360 00 ), HAEMATE-P 500 I.U. (
113 51 22459 00 ) HAEMATE-P 1000 I.U (
113 52
22460 00 )
םש
לעב
םושירה
GENMEDIX
דבלב תורמחהה טורפל דעוימ הז ספוט
!
תושקובמה תורמחהה
ןולעב קרפ
יחכונ טסקט
שדח טסקט
4.2 POSOLOGY
AND
METHOD
OF
ADMINISTRATION
_Prophylaxis_
_[…]_
_Prophylaxis_
_[…]_
_Previously untreated patients _
The safety and efficacy of Haemate in previously untreated patients
have not yet been established.
4.4 SPECIAL
WARNINGS
AND
PRECAUTIONS
FOR USE
_HAEMOPHILIA A_
The formation of neutralising antibodies (inhibitors) to factor
VIII is a known complication in the management of individuals
with haemophilia A. These inhibitors are usually IgG
immunoglobulins directed against the factor VIII procoagulant
activity, which are quantified in Bethesda Units (BU) per ml of
plasma using the modified assay. The risk of developing
inhibitors is correlated to the exposure to anti-haemophilic factor
VIII, this risk being highest within the first 20 exposure days.
Rarely, inhibitors may develop after the first 100 exposure days.
patients treated with human coagulation factor VIII should be
carefully monitored for the development of inhibitors by
appropriate clinical observations and laboratory tests. In patients
with high levels of inhibitor, therapy may not be effective and
other therapeutic options should be considered. See also section
“4.8 Undesirable effects".
_HAEMOPHILIA A_
_Inhibitors_
The formation of neutralising antibodies (inhibitors) to factor
VIII is a known complication in the management of individuals
with haemophilia A. These inhibitors are usually IgG
immunoglobulins directed against the factor VIII procoagulant
activity, which ar

Súhrn charakteristických

FULL PRESCRIBING INFORMATION
1.
NAME OF THE MEDICINAL PRODUCT HAEMATE
®
P 250 IU FVIII / 600 IU VWF
Powder and solvent for solution for injection or infusion HAEMATE
®
P 500 IU FVIII / 1200 IU VWF
Powder and solvent for solution for injection or infusion HAEMATE
®
P 1000 IU FVIII / 2400 IU VWF
Powder and solvent for solution for injection or infusion
2.
QUALITATIVE AND QUANTITATIVE
COMPOSITION
One vial Haemate P 250 IU FVIII / 600 IU VWF contains nominally:
250 IU human coagulation factor VIII (FVIII).
600 IU human von Willebrand factor (VWF).
After reconstitution with 5 ml water for injections, the solution
contains
50 IU/ml of FVIII and 120 IU/ml of VWF.
One vial Haemate P 500 IU FVIII / 1200 IU VWF contains nominally:
500 IU human coagulation factor VIII (FVIII).
1200 IU human von Willebrand factor (VWF).
After reconstitution with 10 ml water for injections, the solution
contains 50 IU/ml of FVIII and 120 IU/ml of VWF.
One vial Haemate P 1000 IU FVIII / 2400 IU VWF contains
nominally: 1000 IU human coagulation factor VIII (FVIII).
2400 IU human von Willebrand factor (VWF).
After reconstitution with 15 ml water for injections, the solution
contains 66.6 IU/ml of FVIII
and 160 IU/ml of VWF.
The FVIII potency (IU) is determined using the European Pharmacopoeia
chromogenic assay.
The specific FVIII activity of Haemate P is approximately 2 - 6 IU of
FVIII/mg protein.
The VWF potency (IU) is measured according to ristocetin cofactor
activity (VWF:RCo)
compared to the International Standard for von Willebrand factor
concentrate (WHO).
The specific VWF activity of Haemate P is approximately 5 - 17 IU of
VWF:RCo/mg protein.
Haemate P is produced from the plasma of human donors.
Excipient with known effect:
Sodium:
Haemate P 250 IU FVIII / 600 IU VWF and Haemate P 500 IU FVIII / 1200
IU VWF
–
approximately 113 mmol/l (2.6 mg/ml)
Haemate P 1000 IU FVIII / 2400 IU VWF
–
approximately 150 mmol/l (3.5 mg/ml)
For the full list of excipients, see section 11 (Description).
3.
PHARMACEUTICAL FORM
Powder and solvent for s