FEIBA 500U

Pays: Israël

Langue: anglais

Source: Ministry of Health

Ingrédients actifs:

FACTOR VIII INHIBITOR BYPASSING FRACTION

Disponible depuis:

TAKEDA ISRAEL LTD

Code ATC:

B02BD03

forme pharmaceutique:

POWDER AND SOLVENT FOR SOLUTION FOR INJECTION/INFUSION

Composition:

FACTOR VIII INHIBITOR BYPASSING FRACTION 500 U/VIAL

Mode d'administration:

I.V

Type d'ordonnance:

Required

Fabriqué par:

BAXTER AG, AUSTRIA

Groupe thérapeutique:

FACTOR VIII INHIBITOR BYPASSING ACTIVITY

Domaine thérapeutique:

FACTOR VIII INHIBITOR BYPASSING ACTIVITY

indications thérapeutiques:

Control of bleeding episodes in haemophilia A patients with Factor VIII Inhibitors and also in patients with acquired Factor VIII Inhibitors.Control of bleeding in hemophilia B patients with inhibitors, if no other specific treatment is available.

Date de l'autorisation:

2012-07-31

Notice patient

העדוה
העדוה
לע
לע
הרמחה
הרמחה
(
(
עדימ
עדימ
ןולעב )תוחיטב
ןולעב )תוחיטב
ל
ל
אפור
אפור
ןכדועמ(
ןכדועמ(
05.2013
05.2013
)
)
ךיראת
________
APRIL 19, 2015
___
םש
רישכת
תילגנאב
רפסמו
םושירה
_
FEIBA NF 500 U, 1000 U
POWDER FOR SOLUTION FOR INJECTION
REG NO: 500 U: 026 14 25389 00; 1000U: 0261525390 00
_
םש
לעב
םושירה
TEVA MEDICAL (MARKETING) LTD., HAORGIM ST 8, ASHDOD 77100
ספוט
הז
דעוימ
טורפל
תורמחהה
דבלב
!
תורמחהה
תושקובמה
קרפ
ןולעב
טסקט
יחכונ
טסקט
שדח
INDICATION
FEIBA NF is indicated for the control of
bleeding episodes in haemophilia A patients
with Factor VIII inhibitors and also in
patients
with
acquired
Factor
VIII
inhibitors.
-
Control of bleeding episodes in haemophilia A
patients with Factor VIII inhibitors and also in
patients with acquired Factor VIII inhibitors.
-
Control of bleeding in hemophilia B patients with
inhibitors,
if
no
other
specific
treatment
is
available.
CONTRAINDICATIONS
POSOLOGY, DOSAGE &
ADMINISTRATION
SURGERY
50-100 U/kg bw should be given at
intervals of up to 6 hours, a maximum
daily dose of 200 U/kg bw should not
be exceeded.
SURGERY
In surgical interventions, an initial dose of 100 U/kg body
weight may be administered preoperatively, and a further
dose of 50 – 100 U/kg body weight may be administered after
6 – 12 hours. As a postoperative maintenance dose, 50 – 100
U/kg body weight may be administered at 6 – 12-hour
intervals; dosage, dosage intervals and duration of the peri-
and postoperative therapy are guided by the surgical
intervention, the patient’s general condition and the clinical
efficacy in each individual case. (The maximum daily dose of
200 U/kg body weight must not be exceeded!)
SURGERY
50-100 U/kg bw should be given at intervals of up to 6
hours, a maximum daily dose of 200 U/kg bw should not
be exceeded.
USE OF FEIBA NF IN SPECIAL PATIENT GROUPS
See Section 5.1 for information

Résumé des caractéristiques du produit

FEIBA 1000U with BAXJECT II Hi-Flow Device_ SPC_
update_
2023
-
01
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
FEIBA 1000U
Powder and solvent for solution for infusion or injection.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
(a) Powder: each glass vial contains:
FEIBA -
1000 U*
Active ingredient:
Human Plasma Protein with a Factor Eight
Inhibitor Bypassing Activity of
400-1200 mg
1000 units
Other ingredients:
Sodium Chloride
160 mg
Sodium Citrate dihydrate
80 mg
1 ml of Feiba 1000U contains 50 U* factor VIII inhibitor bypassing
activity
*) A solution containing 1 U of FEIBA shortens the activated partial
thromboplastin time (aPTT) of a factor VIII
inhibitor plasma to 50% of the buffer value (blank value).
FEIBA also contains the factors II, IX and X mainly in non-activated
form as well as activated factor VII;
factor VIII coagulant antigen (F VIII C:Ag) is present in a
concentration of up to 0.1 U/1 U FEIBA. The
factors of the kallikrein-kinin system are present in trace amounts
only, if at all.
(b) Solvent: each glass vial contains 20 ml sterile water for
injections.
Excipients with known effect:
FEIBA 1000U contains approximately 80 mg sodium per vial.
For a full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Powder and solvent for solution for injection or infusion.
White, off-white or pale green powder. The pH value of the
ready-to-use solution is between 6.8 and 7.6.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
•
Control of bleeding episodes in hemophilia A patients with Factor VIII
inhibitors and also in
patients with acquired Factor VIII inhibitors.
•
Control of bleeding in hemophilia B patients with inhibitors, if no
other specific treatment is
available.
FEIBA 1000U with BAXJECT II Hi-Flow Device_ SPC_
update_02-2023
2
4.2. POSOLOGY AND METHOD OF ADMINISTRATION
The treatment is to be initiated and monitored by a physician
experienced in the management of
coagulation disorders.
_Posology _
Dosage and duration of the treatment depend on the severity of the
h