HAEMOCTIN SDH 500 IU

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

HUMAN PLASMA COAGULATION FACTOR VIII

Available from:

KAMADA LTD, ISRAEL

ATC code:

B02BD02

Pharmaceutical form:

POWDER AND SOLVENT FOR SOLUTION FOR INJECTION

Composition:

HUMAN PLASMA COAGULATION FACTOR VIII 50 IU/ML

Administration route:

I.V

Prescription type:

Required

Manufactured by:

BIOTEST PHARMA GMBH, GERMANY

Therapeutic group:

COAGULATION FACTOR VIII

Therapeutic area:

COAGULATION FACTOR VIII

Therapeutic indications:

Treatment and prophylaxis of bleeding: in patients with haemophilia A (congenital factor VIII deficiency) in patient with acquired factor VIII deficiency.Haemoctin is not effective in controlling the bleeding of patients with Von Willebrond`s disease.

Authorization date:

2021-09-30

Patient Information leaflet

לע העדוה לע העדוה לע העדוה
( הרמחה
( הרמחה
( הרמחה עדימ עדימ עדימ ןולעב )תוחיטב ןולעב )תוחיטב ןולעב )תוחיטב
אפורל
אפורל
אפורל
ןכדועמ(
ןכדועמ(
ןכדועמ(
.102.50
.102.50
.102.50
)
)
) ךיראת
74.4.5
תילגנאב רישכת םש
םושירה רפסמו
HAEMOCTIN SDH 250 IU םושיר רפסמ
30093
-
05
-
121
HAEMOCTIN SDH 500 IU םושיר רפסמ
4
3009
-
6
0
-
121
HAEMOCTIN SDH 1000 IU םושיר רפסמ
5
3009
-
7
0
-
121
םושירה לעב םש
_
_________
KAMADA LTD
ה טורפל דעוימ הז ספוט
דבלב תורמחה
!
תושקובמה תורמחהה
ןולעב קרפ
יחכונ טסקט
שדח טסקט
INDICATION
CONTRAINDIC
ATIONS
POSOLOGY,
DOSAGE &
ADMINISTRAT
ION
Treatment should be initiated under the
supervision of a physician experienced in the
treatment of haemophilia.
During the course of treatment, appropriate
determination of factor VIII levels is advised
to guide the dose to be administered and the
frequency of repeated infusions. In the case of
major surgical interventions in particular,
precise monitoring of the substitution therapy
by means of coagulation analysis (plasma
factor VIII activity) is indispensable.
Individual patients may vary in their response
to factor VIII, achieving different levels of _in _
_vivo_ recovery and demonstrating different
half-lives.
Treatment should be initiated under the supervision
of a physician experienced in the treatment of
haemophilia.
tients
Previously untreated pa
.
No data are available
Treatment monitoring
During the course of treatment, appropriate
determination of factor VIII levels is advised to
guide the dose to be administered and the
frequency of repeated infusions. Individual
patients may vary in their response to factor VIII,
demonstrating different half-lives and recoveries.
Dose based on bodyweight may require
adjustment in underweight or overweight
patients. In the case of major surgical
interventions in particular,

Summary of Product characteristics

HAEMOCTIN
 SDH 250, 500 AND 1000
1.
NAME OF THE MEDICINAL PRODUCT
Haemoctin

SDH 250
Haemoctin

SDH 500
Haemoctin

SDH 1000
Powder and solvent for solution for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Human plasma derived coagulation factor VIII
One vial contains nominally 250, 500 or 1000 IU human plasma derived
coagulation factor
VIII.
Haemoctin

SDH 250 or Haemoctin

SDH 500 contains approximately 50 IU/ml human
coagulation factor VIII when reconstituted with 5 or 10 ml of water
for injections.
Haemoctin

SDH 1000 contains approximately 100 IU/ml human coagulation factor
VIII when
reconstituted with 10 ml of water for injections.
The potency (IU) is determined using the European Pharmacopoeia
chromogenic factor VIII
coagulation assay. The specific activity of Haemoctin

SDH is approximately 100 IU/mg
protein.
Produced from the plasma of human donors.
Excipient with known effect:
One vial contains up to 32.2 mg sodium (1.4 mmol).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder and solvent for solution for injection.
White powder and clear, colourless solvent for solution for injection.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment and prophylaxis of bleeding in patients with haemophilia A
(congenital factor VIII
deficiency) In patient with acquired factor VIII deficiency.
This
preparation
does
not
contain
von
Willebrand
factor
in
pharmacologically
effective
quantities and is therefore not indicated in von Willebrand´s
disease.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Treatment should be under the supervision of a physician experienced
in the treatment of
haemophilia.
Previously untreated patients
No data are available.
Treatment monitoring
During the course of treatment, appropriate determination of factor
VIII levels is advised to
guide the dose to be administered and the frequency of repeated
infusions. Individual patients
may vary in their response to factor VIII, demonstrating different
half-lives and recoveries.
Dose bas