HAEMOCTIN SDH 250 FOR INJECTION 250 iuvial

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

HUMAN BLOOD COAGULATION FACTOR VIII

Available from:

GRIFOLS ASIA PACIFIC PTE. LTD.

ATC code:

B02BD02

Dosage:

250 iu/vial

Pharmaceutical form:

INJECTION, POWDER, FOR SOLUTION

Composition:

HUMAN BLOOD COAGULATION FACTOR VIII 250 iu/vial

Administration route:

INTRAVENOUS

Prescription type:

Prescription Only

Manufactured by:

BIOTEST AG

Authorization status:

ACTIVE

Authorization date:

1998-11-11

Patient Information leaflet

184091
002
INSTRUCTIONS FOR USE   
HAEMOCTIN® SDH 250 / HAEMOCTIN® SDH 500
Powder and solvent for solution for injection
ACTIVE SUBSTANCE 
Human plasma derived coagulation factor VIII
COMPOSITION
One vial of Haemoctin® SDH 250 / Haemoctin® SDH 500 contains 250 IU / 
500 IU human plasma derived coagulation factor VIII when reconstituted 
with either 5 ml or 10 ml of water for injections. Haemoctin® SDH 250 / 
Haemoctin® SDH 500 contains approximately 50 IU/ml human coagulation 
factor VIII.
The potency (IU) is determined using the European Pharmacopoeia chro-
mogenic factor VIII coagulation assay. The specific activity of Haemoctin® 
SDH 250 / Haemoctin® SDH 500 is approximately 100 IU/mg
protein.
Excipients (powder): glycine, sodium chloride, sodium citrate, calcium chloride
Solvent: water for injections
PHARMACEUTICAL FORM
Powder and solvent for solution for injection
PACK SIZES
Haemoctin® SDH 250
Powder and solvent for solution for injection
Each pack contains:
one vial with powder (250 IU)
one vial with 5 ml water for injections
one disposable syringe
one transfer system with integral filter
one butterfly cannula
Haemoctin® SDH 500
Powder and solvent for solution for injection
Each pack contains:
one vial with powder (500 IU)
one vial with 10 ml water for injections
one disposable syringe
one transfer system with integral filter
one butterfly cannula
184.091.002.indd   1
30.03.2011   8:18:39 Uhr
INDICATIONS
Treatment and prophylaxis of bleeding in patients with haemophilia A (congenital 
factor VIII deficiency).
This product may be used in the management of acquired factor VIII
deficiency.
This preparation does not contain von Willebrand factor in pharmacologically effec-
tive quantities and is therefore not indicated in
von Willebrand‘s disease.
DOSAGE AND METHOD OF ADMINISTRATION
Treatment should be initiated under the supervision of a physician experien

Summary of Product characteristics

1
Instructions for use
HAEMOCTIN SDH 250
HAEMOCTIN SDH 500
HAEMOCTIN SDH 1000
ACTIVE SUBSTANCE
Human plasma derived coagulation factor VIII
COMPOSITION
One vial contains nominally 250, 500 or 1000 IU human plasma derived
coagulation factor VIII.
Haemoctin SDH 250 contains approximately 250 IU (50 IU/ml) human
coagulation factor VIII after
reconstitution.
Haemoctin SDH 500 contains approximately 500 IU (100 IU/ml) human
coagulation factor VIII after
reconstitution.
Haemoctin SDH 1000 contains approximately 1000 IU (200 IU/ml) human
coagulation factor VIII
after reconstitution.
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).
List of excipients
Powder: glycine, sodium chloride, sodium citrate, calcium chloride
Solvent: water for injections
PHARMACEUTICAL FORM
Powder and solvent for solution for injection
White powder and clear, colourless solvent for solution for injection.
1 package Haemoctin SDH contains:
1 vial (20ml), of glass type 1 acc. to Ph. Eur., with powder
Freeze-drying stoppers, of chlorobutyl, type 1 acc. to Ph. Eur.
1 vial, glass type 1 acc. to Ph. Eur., with 5 ml solvent
Injection stoppers, of bromobutyl, type 1 acc. to Ph. Eur.
The pack also contains:
1 disposable syringe (5ml), 1 transfer system with integral filter, 1
butterfly cannula.
INDICATIONS
Treatment and prophylaxis of bleeding in patients with haemophilia A
(congenital factor VIII
deficiency).
This product may be used in the management of 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.
DOSAGE AND METHOD OF ADMINISTRATION
Treatment should be initiated under the supervision of a physician
experienced in the treatment of
haemophilia.
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