FEIBA 1000U

Maa: Israel

Kieli: englanti

Lähde: Ministry of Health

Aktiivinen ainesosa:

FACTOR VIII INHIBITOR BYPASSING FRACTION

Saatavilla:

TAKEDA ISRAEL LTD

ATC-koodi:

B02BD03

Lääkemuoto:

POWDER AND SOLVENT FOR SOLUTION FOR INJECTION/INFUSION

Koostumus:

FACTOR VIII INHIBITOR BYPASSING FRACTION 1000 U/VIAL

Antoreitti:

I.V

Prescription tyyppi:

Required

Valmistaja:

TAKEDA MANUFACTURING AUSTRIA AG, AUSTRIA

Terapeuttinen ryhmä:

FACTOR VIII INHIBITOR BYPASSING ACTIVITY

Terapeuttinen alue:

FACTOR VIII INHIBITOR BYPASSING ACTIVITY

Käyttöaiheet:

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.

Valtuutus päivämäärä:

2022-07-31

Pakkausseloste

1
PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS
(PREPARATIONS) -
1986
This medicine is dispensed with a doctor’s prescription only
FEIBA 1000 U
POWDER AND SOLVENT FOR SOLUTION FOR INJECTION OR INFUSION
ACTIVE INGREDIENT
Each vial of FEIBA 1000U contains 1000 units of Factor VIII inhibitor
bypassing fraction
Inactive ingredients and allergens: See ‘Important information about
some of this
medicine’s ingredients’ in section 2, and section 6 ‘Additional
information’.
READ THE ENTIRE LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE. This leaflet
contains concise information about this medicine. If you have any
further questions,
consult your doctor or pharmacist.
This medicine has been prescribed for you. Do not pass it on to
others. It may harm
them, even if it seems to you that their medical condition is similar
to yours.
1.
WHAT IS THIS MEDICINE INTENDED FOR?
•
Controlling bleeding in hemophilia A patients with Factor VIII
Inhibitors
(antibodies) and also in patients with acquired Factor VIII
Inhibitors.
•
Controlling bleeding in hemophilia B patients with inhibitors, if no
other specific
treatment is available.
THERAPEUTIC GROUP: blood clotting agents.
FEIBA is a preparation made from human plasma which allows stopping
and preventing
bleeding (hemostasis), even when individual coagulation factors are
reduced or absent.
2.
BEFORE USING THIS MEDICINE
DO NOT USE THIS MEDICINE
In the following conditions, if there are alternative therapeutic
options:
•
if you are sensitive (allergic) to the active ingredient or to any of
the other
ingredients in this medicine (listed in section 6)
•
if a disseminated intravascular coagulation (DIC) exists. (DIC is a
consumption
coagulopathy, a life-threatening condition in which excessive blood
coagulation
with pronounced blood clot formation in the blood vessels occurs. This
then leads
to a consumption of the coagulation factors in the entire body).
•
in case of acute thrombosis and/or embolism (including myocardial
infarction)
2
SPECIAL

Valmisteyhteenveto

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