HAEMOCOMPLETTAN P 2 G

Land: Israel

Språk: engelska

Källa: Ministry of Health

Aktiva substanser:

HUMAN FIBRINOGEN

Tillgänglig från:

CSL BEHRING LTD., ISRAEL

ATC-kod:

B02BC10

Läkemedelsform:

POWDER FOR SOLUTION FOR INJ/INF

Sammansättning:

HUMAN FIBRINOGEN 1800 - 2600 MG / 1 VIALS

Administreringssätt:

I.V

Receptbelagda typ:

Required

Tillverkad av:

CSL BEHRING GmbH, GERMANY

Terapeutisk grupp:

FIBRINOGEN, HUMAN

Terapiområde:

FIBRINOGEN, HUMAN

Terapeutiska indikationer:

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.

Tillstånd datum:

2014-07-31

Bipacksedel

העדוה
העדוה
לע
לע
הרמחה
הרמחה
(
(
עדימ
עדימ
ןולעב )תוחיטב
ןולעב )תוחיטב
ל
ל
אפור
אפור
ןכדועמ(
ןכדועמ(
05.2013
05.2013
)
)
ךיראת
09/09/2014
םש
רישכת
תילגנאב
רפסמו :םושירה
HAEMOCOMPLETTAN P 1 G (
141 35 31819 00
), HAEMOCOMPLETTAN P 2 G (
141 36 31820 00
)
םש
לעב
םושירה
GENMEDIX
דבלב תורמחהה טורפל דעוימ הז ספוט
!
תושקובמה תורמחהה
ןולעב קרפ
יחכונ טסקט
שדח טסקט
4.2 POSOLOGY
AND
METHOD
OF
ADMINISTRATION
_POSOLOGY_
Before administration of Haemocomplettan P 1g/2g_ _
the fibrinogen level should be determined using the
method of Clauss.
Furthermore, the amount to be administered and the
frequency of application of Haemocomplettan P 1g/2g_ _
should always be oriented to the degree of bleeding
and the clinical efficacy in the individual case.
Generally, 1 to 2 g Fibrinogen is administered initially,
with subsequent infusions as required.
The critical plasma fibrinogen level below which
haemorrhages may occur is 100 mg/dl
Normal values
are in the range of 200 to 450 mg/dl.
The circulating fibrinogen level should not be raised
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 m

Produktens egenskaper

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