HAEMOCOMPLETTAN P POWDER FOR SOLUTION FOR INJECTION OR INFUSION 1GVIAL

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

Human fibrinogen

Available from:

CSL BEHRING PTE. LTD.

ATC code:

B02BB01

Pharmaceutical form:

INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

Composition:

Human fibrinogen 0.900-1.300 g/vial

Administration route:

INTRAVENOUS

Prescription type:

Prescription Only

Manufactured by:

CSL Behring GmbH (Drug Product)

Authorization status:

ACTIVE

Authorization date:

2020-02-28

Summary of Product characteristics

1.
NAME OF THE MEDICINAL PRODUCT
Haemocomplettan
®
P 1g/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 20 mg/ml human fibrinogen after reconstitution
with 50 ml water for
injections for Haemocomplettan P 1g or 100 ml water for injections for
Haemocomplettan P
2g.
The content of clottable fibrinogen is determined according to PH.
Eur. monograph for
human fibrinogen.
Excipients recognised to have a known effect: Sodium up to 164 mg (7.1
mmol) per 1g
fibrinogen.
For a 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
Therapy and prophylaxis of
_ _
haemorrhagic diatheses in:
•
Congenital hypo- or afibrinogenaemia
.
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
coagulation assays is essential.
1.
Prophylaxis in patients with congenital hypo- or afibrinogenaemia and
known bleeding
tenden