HAEMOCOMPLETTAN P 1 G

Država: Izrael

Jezik: engleski

Izvor: Ministry of Health

Aktivni sastojci:

HUMAN FIBRINOGEN

Dostupno od:

CSL BEHRING LTD., ISRAEL

ATC koda:

B02BC10

Farmaceutski oblik:

POWDER FOR SOLUTION FOR INJ/INF

Sastav:

HUMAN FIBRINOGEN 900 - 1300 MG / 1 VIALS

Administracija rute:

I.V

Tip recepta:

Required

Proizveden od:

CSL BEHRING GmbH, GERMANY

Terapijska grupa:

FIBRINOGEN, HUMAN

Područje terapije:

FIBRINOGEN, HUMAN

Terapijske indikacije:

Haemocomplettan P 1g/2g, Fibrinogen Concentrate (Human) is indicated for the treatment of acute bleeding episodes in patients with congenital fibrinogen deficiency, including afibrinogenemia and hypofibrinogenemia.Haemocomplettan P 1g/2g is not indicated for dysfibrinogenemia.

Datum autorizacije:

2014-07-31

Svojstava lijeka

1.
NAME OF THE MEDICINAL PRODUCT
HAEMOCOMPLETTAN
® P 1G
HAEMOCOMPLETTAN
® P 2G
Powder for solution for injection / infusion_ _
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Haemocomplettan is presented as a powder for solution for injection or
infusion for
intravenous administration containing 1g or 2g human fibrinogen per
vial.
The product contains approx. 20 mg/ml human fibrinogen after
reconstitution with 50 or
100 ml water for injections.
The content of clottable fibrinogen is determined according to Ph.
Eur. monograph for
human fibrinogen.
Excipients with known effect: Sodium up to 164 mg (7.1 mmol) per 1g
fibrinogen.
For the full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Powder for solution for injection_/_infusion.
White powder
4.
CLINICAL PARTICULARS
4.1
Therapeutic indications
Haemocomplettan P 1g/2g, Fibrinogen Concentrate (Human) is indicated
for the treatment
of acute bleeding episodes in patients with congenital fibrinogen
deficiency, including
afibrinogenemia and hypofibrinogenemia.
Haemocomplettan P 1g/2g is not indicated for dysfibrinogenemia.
4.2 Posology and method of administration
Treatment should be initiated under the supervision of a physician
experienced in the
treatment of coagulation disorders.
_POSOLOGY_
The dosage and duration of the substitution therapy depend on the
severity of the disorder,
location and extent of bleeding and the patient’s clinical
condition.
The (functional) fibrinogen level should be determined in order to
calculate individual
dosage and the amount and frequency of administration should be
determined on an
individual patient basis by regular measurement of plasma fibrinogen
level and continuous
monitoring of the clinical condition of the patient and other
replacement therapies used.
Normal plasma fibrinogen level is in the range of 1.5
–
4.5 g/l. The critical plasma
fibrinogen level below which haemorrhages may occur is approximately
0.5
–
1.0 g/l. In
case of major surgical intervention, precise monitoring of replacement
therapy by
coagulati