BERIPLEX PN 500

Land: Ísrael

Tungumál: enska

Heimild: Ministry of Health

Virkt innihaldsefni:

COAGULATION FACTOR II (HUMAN); COAGULATION FACTOR IX (HUMAN- RFIXFC); COAGULATION FACTOR VII (HUMAN); COAGULATION FACTOR X (HUMAN); PROTEIN C; PROTEIN S ANTIGEN

Fáanlegur frá:

CSL BEHRING LTD., ISRAEL

ATC númer:

B02BD01

Lyfjaform:

POWDER AND SOLVENT FOR SOLUTION FOR INJECTION

Samsetning:

COAGULATION FACTOR II (HUMAN) 400 - 960 IU; COAGULATION FACTOR VII (HUMAN) 200 - 500 IU; COAGULATION FACTOR IX (HUMAN- RFIXFC) 400 - 620 IU; COAGULATION FACTOR X (HUMAN) 440 - 1200 IU; PROTEIN C 300 - 900 IU; PROTEIN S ANTIGEN 240 - 760 IU

Stjórnsýsluleið:

I.V

Gerð lyfseðils:

Required

Framleitt af:

CSL BEHRING GmbH, GERMANY

Lækningarsvæði:

COAGULATION FACTOR IX, II, VII AND X IN COMBINATION

Ábendingar:

Treatment and perioperative prophylaxis of bleedings in acquired deficiency of the prothrombin complex coagulation factors, such as deficiency caused by treatment with vitamin K antagonists, or in case of overdose of vitamin K antagonists, when rapid correction of the deficiency is required.

Leyfisdagur:

2017-03-31

Upplýsingar fylgiseðill

העדוה
העדוה
לע
לע
הרמחה
הרמחה
(
(
עדימ
עדימ
ןולעב )תוחיטב
ןולעב )תוחיטב
ל
ל
אפור
אפור
ןכדועמ(
ןכדועמ(
05.2013
05.2013
)
)
ךיראת
31/08/2014
םש
רישכת
תילגנאב
רפסמו
:םושירה
BERIPLEX
® P/N 500 (
147 88 33309 00
), BERIPLEX
® P/N 250 (
147 87 33308 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
BLEEDING AND PERIOPERATIVE PROPHYLAXIS OF BLEEDINGS DURING
VITAMIN K ANTAGONIST TREATMENT.
The dose will depend on the INR before treatment and the
targeted INR. In the following table approximate doses (ml/kg
body weight of the reconstituted product and IU FIX/kg b.w.)
required for normalisation of INR (e.g. ≤ 1.3) at different initial
INR levels are given.
Initial INR
2.0
–
3.9
4.0
–
6.0
>
6.0
Approximate dose ml/kg
body weight
1
1.4
2
BLEEDING AND PERIOPERATIVE PROPHYLAXIS OF BLEEDINGS DURING
VITAMIN K ANTAGONIST TREATMENT.
The dose will depend on the INR before treatment and the
targeted INR. The pre-treatment INR should be measured as
close as possible to the time of dosing in order to calculate the
appropriate dose of Beriplex. In the following table approximate
doses (ml/kg body weight of the reconstituted product and IU
Factor IX/kg b.w.) required for normalisation of INR (e.g. ≤
1.3) at different initial INR levels are given.
Pre-treatment INR
2.0
–
3.9
4.0
–
6.0
>
6.0
Approximate dose ml/kg
body weight
1
1.4
2
Approximate dose IU
(Factor IX)/kg body
weight
25
35
50
It is recommended that the maximum single dose should not
exceed 5000 IU FIX.
The correction of the vitamin K antagonist-induced impairment of
haemostasis is reached at the latest 30 minutes after the injection
and will persist for approximately 6 – 8 hours.
However, the effect of vitamin K, if administered simultaneously,
is usually achieved within 4 – 6

Vara einkenni

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
BERIPLEX
®
P/N 250
,
powder and solvent for solution for injection.
BERIPLEX
®
P/N 500,
powder and solvent for solution for injection.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Beriplex is presented as powder and solvent for solution for injection
containing human
prothrombin complex. The product nominally contains the following IU
of the human
coagulation factors tabled below:
NAME OF THE
INGREDIENTS
CONTENT AFTER
RECONSTITUTION
(IU/ML)
BERIPLEX P/N 250
CONTENT PER VIAL
(IU)
BERIPLEX P/N 500
CONTENT PER VIAL
(IU)
ACTIVE INGREDIENTS
Human
coagulation factor II
20
–
48
200
–
480
400
–
960
Human
coagulation factor VII
10
–
25
100
–
250
200
–
500
Human
coagulation factor IX
20
–
31
200
–
310
400
–
620
Human
coagulation factor X
22
–
60
220
–
600
440
–
1200
FURTHER ACTIVE
INGREDIENTS
Protein C
15
–
45
150
–
450
300
–
900
Protein S Antigen
12
–
38
120
–
380
240
–
760
The total protein content is 6
–
14 mg/ml of reconstituted solution.
The specific activity of factor IX is 2.5 IU per mg total protein.
The activities of all coagulation factors as well as Protein C and S
(antigen) have been tested
according to the current valid international WHO-Standards.
Excipients with known effect:
Sodium up to 343 mg (approximately 15 mmol) per 100 ml solution.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder and solvent for solution for injection.
White or slightly coloured powder or friable solid.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
-
Treatment and perioperative prophylaxis of bleedings in acquired
deficiency of the
prothrombin complex coagulation factors, such as deficiency caused by
treatment with
vitamin K antagonists, or in case of overdose of vitamin K
antagonists, when rapid
correction of the deficiency is required.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
_POSOLOGY _
_ _
Only general dosage guidelines are given below. Treatment should be
initiated under the
supervision