HAEMOCTIN SDH 1000 FOR INJECTION 1000 iuvial

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

Human coagulation factor VIII

Available from:

GRIFOLS ASIA PACIFIC PTE. LTD.

ATC code:

B02BD02

Pharmaceutical form:

INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

Composition:

Human coagulation factor VIII 1000 iu/vial

Administration route:

INTRAVENOUS

Prescription type:

Prescription Only

Manufactured by:

Biotest AG (Lyophilized drug product)

Authorization status:

ACTIVE

Authorization date:

2017-10-04

Patient Information leaflet

Instructions for use
HAEMOCTIN® SDH 250 / 500 / 1000
HAEMOCTIN® SDH 250 / HAEMOCTIN® SDH 500 / HAEMOCTIN® SDH 1000
Powder and solvent for solution for injection
ACTIVE SUBSTANCE
Human plasma derived coagulation factor VIII
COMPOSITION
Haemoctin 250 contains approximately 250 IU (50 IU/ml) human
coagulation factor VIII after
reconstitution.
Haemoctin 500 contains approximately 500 IU (100 IU/ml) human
coagulation factor VIII after
reconstitution.
Haemoctin 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.
Excipients (powder): glycine, sodium chloride, sodium citrate, calcium
chloride (One vial contains up
to 32.2 mg sodium (1.4 mmol).)
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 5 ml
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 5 ml water for injections
one disposable syringe 5 ml
one transfer system with integral filter
one butterfly cannula
Haemoctin® SDH 1000
Powder and solvent for solution for injection
Each pack contains:
one vial with powder (1000 IU)
one vial with 5 ml water for injections
one disposable syringe 5 ml
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one transfer system with integral filter
one 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
i

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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