FIBROGAMMIN 250 IU FXIII

Land: Israel

Språk: engelsk

Kilde: Ministry of Health

Aktiv ingrediens:

FACTOR XIII

Tilgjengelig fra:

CSL BEHRING LTD., ISRAEL

ATC-kode:

B02BD07

Legemiddelform:

POWDER AND SOLVENT FOR SOLUTION FOR INJECTION/SOLUTION FOR INFUSION

Sammensetning:

FACTOR XIII 200 - 320 IU

Administreringsrute:

I.V

Resept typen:

Required

Produsert av:

CSL BEHRING GmbH, GERMANY

Terapeutisk gruppe:

COAGULATION FACTOR XIII

Terapeutisk område:

COAGULATION FACTOR XIII

Indikasjoner:

Fibrogammin is indicated for adult and paediatric patients • for prophylactic treatment of congenital FXIII deficiency and • for peri-operative management of surgical bleeding with congentital FXIII deficiency. Fibrogammin is furthermore indicated • for haemorrhagic diatheses caused completely or in part by acquired FXIII deficiency • for supportive therapy in case of disturbance in wound healing, especially in ulcus cruris, after large surgery or injuries.

Autorisasjon dato:

2023-05-31

Informasjon til brukeren

1.
NAME OF THE MEDICINAL PRODUCT
FIBROGAMMIN
®
250 IU FXIII
FIBROGAMMIN
®
1250 IU FXIII
Powder and solvent for solution for injection or infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE SUBSTANCE: Fibrogammin is a purified concentrate of blood
coagulation factor XIII
(FXIII). It is derived from human plasma, and is presented as a white
powder.
Each vial contains nominally 250 or 1250 IU human plasma coagulation
factor XIII.
Fibrogammin contains approximately 62.5 IU/ml (250 IU/4 ml or 1250
IU/20 ml) of
human plasma coagulation factor XIII when reconstituted with 4 or 20
ml water for
injections, respectively.
The specific activity of Fibrogammin is approximately 3.1
–
13.3 IU/mg protein.
Excipients with known effect:
Sodium (as chloride and hydroxide): 2.78 to 4.36 mg/ml (120 to 189
mmol/L)
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder and solvent for solution for injection /infusion.
White powder and clear, colourless solvent.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Fibrogammin is indicated for adult and paediatric patients
•
for prophylactic treatment of congenital FXIII deficiency and
•
for peri-operative management of surgical bleeding with congentital
FXIII deficiency.
Fibrogammin is furthermore indicated
•
for haemorrhagic diatheses caused completely or in part by acquired
FXIII deficiency
•
for supportive therapy in case of disturbance in wound healing,
especially in ulcus
cruris, after large surgery or injuries.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
_POSOLOGY _
1 ml is equivalent to 62.5 IU, and 100 IU are equivalent to 1.6 ml,
respectively.
Important:
The amount to be administered and the frequency of administration
should always be
oriented towards the clinical efficacy in the individual case.
_DOSAGE _
The dosing regimen should be individualized based on body weight,
laboratory values, and
the patient’s clinical condition.
Routine prophylaxis dosing schedule for treatment of congenital FXIII
deficiency
Initial dose
•
40 Interna

Preparatomtale

לא מצאנו את מה שחיפשת.
כדאי לבדוק אם הכתובת שהזנת נכונה
נשמח לסייע בכתובת [e-mail]
(1)