FANHDI 100 IUML (FACTOR VIII)

Maa: Israel

Kieli: englanti

Lähde: Ministry of Health

Aktiivinen ainesosa:

FACTOR VIII (HUMAN)

Saatavilla:

MEDICI MEDICAL LTD, ISRAEL

ATC-koodi:

B02BD02

Lääkemuoto:

POWDER FOR SOLUTION FOR INJECTION

Koostumus:

FACTOR VIII (HUMAN) 1000 IU

Antoreitti:

I.V

Prescription tyyppi:

Required

Valmistaja:

INSTITUTO GRIFOLS S.A.,SPAIN,BARCELONA

Terapeuttinen ryhmä:

COAGULATION FACTOR VIII

Terapeuttinen alue:

COAGULATION FACTOR VIII

Käyttöaiheet:

Is indicated for the prevention and control of bleeding in patients with moderate or severe factor VIII deficiency due to classical hemophilia A . Fanhdi is not effective in controlling the bleeding of patients with Von Willebrond's disease.

Valtuutus päivämäärä:

2020-12-31

Valmisteyhteenveto

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7 1. NAME OF THE MEDICINAL PRODUCT
FANHDI
®
25 IU/ML (FACTOR VIII)
FANHDI
®
50 IU/ML (FACTOR VIII)
FANHDI
®
100 IU/ML 1000 IU/10 ML (FACTOR VIII)
FANHDI
® 100 IU/ML, 1500 IU/15 ML (FACTOR VIII)
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Human coagulation factor VIII, Ph. Eur.
Fanhdi® is presented as a lyophilised powder for solution for
injection containing nominally 250, 500,
1000 or 1500 IU human coagulation factor VIII per vial.
The product contains approximately 25, 50 or 100 IU/ml of human
coagulation factor VIII when
reconstituted with 10 ml of Water for Injections for the presentations
of 250, 500 and 1000 IU. The
presentation of 1500 IU is reconstituted with 15 ml of Water for
Injections and contains approximately
100 IU/ml.
The factor VIII:C potency (IU) is determined using the European
Pharmacopoeia chromogenic
assay. The specific activity of Fanhdi® is at least 2.5 to 10 IU
factor VIII:C/mg protein depending on
its strength (250, 500, 1000 or 1500 IU).
For a full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Powder and solvent for solution for injection.
Vial containing white or pale yellow powder and syringe with Water for
Injections (solvent).
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Fanhdi
®
is indicated for the prevention and control of bleeding in patients
with moderate or severe
factor VIII deficiency due to classical hemophilia A.
Fanhdi
®
is not effective in controlling the bleeding of patients with von
Willebrand's disease.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
The dose and duration of Fanhdi
®
treatment must be adjusted according to each patient's needs.
The required dosage may be estimated using the following formula:
Number of factor VIII = Body weight x Desired factor VIII x 0.5
units required (I.U.) (kg) rise (%)
This calculation is based on the empirical finding that 1 I.U. of
factor VIII per kg body weight raises
the plasma factor VIII activity approximately 2% (i.e. 0.5 I.U./kg are
required for 1% increase in
plasma factor VIII