Advate
Kraj: Unia Europejska
Język: angielski
Źródło: EMA (European Medicines Agency)
Ulotka dla pacjenta
(PIL)
29-11-2023
Charakterystyka produktu
(SPC)
29-11-2023
Sprawozdanie z oceny publicznego
(PAR)
15-01-2018
Składnik aktywny:
Octocog alfa
Dostępny od:
Takeda Manufacturing Austria AG
Kod ATC:
B02BD02
INN (International Nazwa):
octocog alfa
Grupa terapeutyczna:
Antihemorrhagics
Dziedzina terapeutyczna:
Hemophilia A
Wskazania:
Treatment and prophylaxis of bleeding in patients with haemophilia A (congenital factor-VIII deficiency).Advate does not contain von Willebrand factor in pharmacologically effective quantities and is therefore not indicated in von Willebrand disease.
Podsumowanie produktu:
Revision: 32
Status autoryzacji:
Authorised
Data autoryzacji:
2004-03-02
Ulotka dla pacjenta
247
B. PACKAGE LEAFLET
248
PACKAGE LEAFLET: INFORMATION FOR THE USER
ADVATE 250 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
ADVATE 500 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
ADVATE 1000 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
ADVATE 1500 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
ADVATE 2000 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
ADVATE 3000 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
octocog alfa (recombinant human 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.
-
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. This includes any
possible side effects not listed
in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1.
What ADVATE is and what it is used for
2.
What you need to know before you use ADVATE
3.
How to use ADVATE
4.
Possible side effects
5.
How to store ADVATE
6.
Contents of the pack and other information
1.
WHAT ADVATE IS AND WHAT IT IS USED FOR
ADVATE contains the active substance octocog alfa, human coagulation
factor VIII produced by
recombinant DNA technology. Factor VIII is necessary for the blood to
form clots and stop bleedings.
In patients with haemophilia A (inborn lack of factor VIII), it is
missing or not working properly.
ADVATE is used for the treatment and prevention of bleeding in
patients of all age groups with
haemophilia A (an inherited bleeding disorder caused by lack of factor
VIII).
ADVATE is prepared without the addition of any human- or
animal-derived protein in the entire
manufacturing process.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE ADVATE
DO NOT USE ADVATE
-
if you are allergic to octocog alfa or any of the other ingredients of
this medicine (listed in
section 6)
-
if you are al
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Charakterystyka produktu
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
ADVATE 250 IU powder and solvent for solution for injection.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains nominally 250 IU human coagulation factor VIII
(rDNA), octocog alfa. ADVATE
contains approximately 50 IU per ml of human coagulation factor VIII
(rDNA), octocog alfa after
reconstitution.
The potency (International Units) is determined using the European
Pharmacopoeia chromogenic
assay. The specific activity of ADVATE is approximately 4 520-11 300
IU/mg protein.
Octocog alfa (human coagulation factor VIII (rDNA)) is a purified
protein that has 2332 amino acids.
It is produced by recombinant DNA technology in Chinese hamster ovary
(CHO) cells. Prepared
without the addition of any (exogenous) human- or animal-derived
protein in the cell culture process,
purification or final formulation.
Excipients with known effect
This medicinal product contains 0.45 mmol sodium (10 mg) per vial.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder and solvent for solution for injection.
Powder: White to off-white friable powder.
Solvent: Clear and colourless solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment and prophylaxis of bleeding in patients with haemophilia A
(congenital factor VIII
deficiency). ADVATE is indicated in all age groups.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Treatment should be initiated under the supervision of a physician
experienced in the treatment of
haemophilia and with resuscitation support immediately available in
case of anaphylaxis.
Posology
The dose and duration of the substitution therapy depend on the
severity of the factor VIII deficiency,
on the location and extent of the bleeding and on the patient’s
clinical condition.
The number of units of factor VIII is expressed in International Units
(IU), which are related to the
WHO standard for factor VIII products. Factor VIII activity in plasma
is expressed either as a
percentage (relative to nor
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