AFSTYLA POWDER AND SOLVENT FOR SOLUTION FOR INJECTION 250IUVIAL

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

lonoctocog alfa

Available from:

CSL BEHRING PTE. LTD.

ATC code:

B02BD02

Pharmaceutical form:

INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

Composition:

lonoctocog alfa 250IU/Vial

Administration route:

INTRAVENOUS

Prescription type:

Prescription Only

Manufactured by:

CSL Behring GmbH (Solvent)

Authorization status:

ACTIVE

Authorization date:

2019-09-27

Summary of Product characteristics

1.
NAME OF THE MEDICINAL PRODUCT
AFSTYLA 250IU powder and solvent for solution for injection
AFSTYLA 500IU powder and solvent for solution for injection
AFSTYLA 1000IU powder and solvent for solution for injection
AFSTYLA 1500IU powder and solvent for solution for injection
AFSTYLA 2000IU powder and solvent for solution for injection
AFSTYLA 2500IU powder and solvent for solution for injection
AFSTYLA 3000IU powder and solvent for solution for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One vial contains nominally 250/500/1000/1500/2000/2500/3000 IU
recombinant, single
chain coagulation factor VIII
_ _
(rVIII-SingleChain, INN = lonoctocog alfa).
After reconstitution with 2.5 mL water for injections (250/500/1000
IU) the solution
contains 100/200/400 IU/mL of rVIII-SingleChain. When reconstituted
with 5 mL water for
injections (1500/2000/2500/3000 IU) the solution contains
300/400/500/600 IU/mL of
rVIII-SingleChain
The potency (IU) is determined using the European Pharmacopoeia
chromogenic assay. The
specific activity of AFSTYLA is 7400 - 16000 IU/mg/ protein.
Lonoctocog alfa is a single chain recombinant factor VIII produced in
Chinese hamster
ovary (CHO) cells. It is a construct where most of the B-domain
occurring in wild-type,
full-length factor VIII and 4 amino acids of the adjacent acidic a3
domain were removed
(amino acids 765 to 1652 of full-length factor VIII).
The newly formed linkage of the heavy and light chain of factor VIII
introduces a new N-
glycosylation site. As the furin cleavage site present in wild type
factor VIII between the B-
domain and the a3 domain was removed, the recombinant factor VIII is
expressed as a
single chain factor VIII molecule.
Excipient with known effect:
Sodium approximately 0.23-0.30 mmol/mL (5.4-7.0 mg/mL).
For the full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Powder and solvent for solution for injection.
White or slightly yellow powder or friable mass and clear, colourless
solvent for solution
for injection.
4.
CLINICAL PARTICULARS
4.1
THERA