Recombinate 500 IU, powder and solvent for solution for injection

Država: Irska

Jezik: engleski

Izvor: HPRA (Health Products Regulatory Authority)

Aktivni sastojci:

Factor viii, human recombinant

Dostupno od:

Baxalta Innovations GmbH

ATC koda:

B02BD; B02BD02

INN (International ime):

Factor viii, human recombinant

Doziranje:

500 IU international unit(s)

Farmaceutski oblik:

Powder and solvent for solution for injection

Administracija rute:

administered intravenously

Jedinice u paketu:

Pack size of 1

Tip recepta:

Product subject to prescription which may not be renewed (A)

Terapijska grupa:

antihaemorrhagics: blood coagulation factor VIII

Područje terapije:

Blood coagulation factors; coagulation factor VIII

Terapijske indikacije:

Treatment and prophylaxis of bleeding in patients with Haemophilia A (congenital Factor VIII deficiency). This product does not contain von Willebrand factor and is therefore not indicated in von Willebrand’s disease.

Status autorizacije:

Not marketed

Datum autorizacije:

1993-10-26

Uputa o lijeku

Package leaflet: Information for the user
Recombinate 250 IU/10 ml powder and solvent for solution for
injection.
Recombinate 500 IU/10 ml powder and solvent for solution for
injection.
Recombinate 1000 IU/10 ml powder and solvent for solution for
injection.
Octocog alfa (recombinant coagulation factor VIII)
Read all of this leaflet carefully before you start using this
medicine because it contains important
information for you.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor, or pharmacist or
nurse.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
-
If you get any side effects talk to your doctor, or pharmacist or
nurse. This includes any possible
side effects not listed in this leaflet.
What is in this leaflet
1.
What Recombinate is and what it is used for
2.
What you need to know before you use Recombinate
3.
How to use Recombinate
4.
Possible side effects
5.
How to store Recombinate
6.
Contents of the pack and other information
1.
What Recombinate is and what it is used for
Recombinate belongs to a pharmacotherapeutic group called blood
coagulation factor VIII.
Recombinate is used in patients with haemophilia A (congenital factor
VIII deficiency) for

prevention of bleeding

treatment of bleeding (e.g. muscle bleeding, oral bleeding, bleeding
at the site of surgery).
The product does not contain von Willebrand factor and is therefore
not to be used in von Willebrand’s
disease (a special blood coagulation disorder).
2.
What you need to know before you use Recombinate
Do not use Recombinate

If you are allergic to octocog alfa, to mouse, bovine or hamster
proteins or to any of the other
ingredients of this medicine (listed in section 6).
If you are unsure about this, ask your doctor.
Warnings and precautions
When allergic reactions occur:

There is a rare chance that you may experience an anaphylactic
reaction (a severe, sudden allergic
reac

Svojstava lijeka

Health Products Regulatory Authority
18 November 2020
CRN00C1DY
Page 1 of 11
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Recombinate 500 IU, powder and solvent for solution for injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Octocog alfa 50 IU per ml of reconstituted solution
After reconstitution: One vial of 10 ml contains 500 IU octocog alfa
Recombinate 500 IU, contains nominally 500 IU octocog alfa,
recombinant, coagulation factor VIII per vial.
The product contains approximately 50 IU/ml octocog alfa, recombinant
coagulation factor VIII when reconstituted with 10 ml
of sterile water for injections.
The potency is determined using the European Pharmacopoeia chromogenic
assay against the FDA Mega Standard calibrated
to the WHO Standard. The specific activity of Recombinate is
approximately 4000 - 8000 IU/mg protein.
Recombinate contains recombinant coagulation factor VIII (INN: octocog
alfa). Octocog alfa (recombinant coagulation factor
VIII) is a purified protein consisting of 2332 amino acids. It has an
amino acid sequence that is comparable to factor VIII, and
post-translational modifications that are similar to the plasma
derived molecule. Recombinant coagulation factor VIII is a
glycoprotein that is expressed by genetically engineered mammalian
cells derived from a Chinese Hamster Ovary cell line.
Excipients with known effect: sodium
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Powder and solvent for solution for injection.
White to off-white friable powder.
The solvent (sterilized water for injections) is a clear and
colourless liquid.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment and prophylaxis of bleeding in patients with Haemophilia A
(congenital Factor VIII deficiency).
This product does not contain von Willebrand factor and is therefore
not indicated in von Willebrand’s disease.
Recombinate is indicated for all age groups from neonates to adults.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
4.2.1 POSOLOGY
The dosage and duration of