Refacto AF 250IU powder and solvent for solution for injection

Χώρα: Αρμενία

Γλώσσα: Αγγλικά

Πηγή: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Δραστική ουσία:

moroctocog alfa

Διαθέσιμο από:

Wyeth Farma S.A.

Φαρμακολογική κατηγορία (ATC):

B02BD02

INN (Διεθνής Όνομα):

moroctocog alfa

Δοσολογία:

250IU

Φαρμακοτεχνική μορφή:

powder and solvent for solution for injection

Μονάδες σε πακέτο:

glass vial, solvent in pre-filled syringe 4ml, vial adapter, sterile infusion set, (2) alcohol swabs, plaster, gauze pad

Τρόπος διάθεσης:

Prescription

Καθεστώς αδειοδότησης:

Registered

Ημερομηνία της άδειας:

2020-12-30

Φύλλο οδηγιών χρήσης

Page 1 of 9
2020-0061631, 2020-0062642
PACKAGE LEAFLET: INFORMATION FOR THE USER
REFACTO AF 250 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
REFACTO AF 500 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
REFACTO AF 1000 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
REFACTO AF 2000 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
moroctocog 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 further questions, please ask your doctor or pharmacist.
-
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. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1.
What ReFacto AF is and what it is used for
2.
What you need to know before you use ReFacto AF
3.
How to use ReFacto AF
4.
Possible side effects
5
How to store ReFacto AF
6.
Contents of the pack and other information
1.
WHAT REFACTO AF IS AND WHAT IT IS USED FOR
ReFacto AF contains the active substance moroctocog alfa, human
coagulation factor VIII. Factor VIII
is necessary for the blood to form clots and stop bleedings. In
patients with haemophilia A (inborn
factor VIII deficiency), it is missing or not working properly.
ReFacto AF is used for the treatment and prevention of bleeding
(prophylaxis) in adults and children
of all ages (including newborns) with haemophilia A.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE REFACTO AF
DO NOT USE REFACTO AF
-
if you are allergic to moroctocog alfa or any of the other ingredients
of this medicine (listed in
section 6).
-
if you are allergic to hamster proteins.
If you are unsure about this, ask your doctor.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before using ReFacto AF
-
if you experience allergic react

Αρχείο Π.Χ.Π.

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
ReFacto AF 250 IU powder and solvent for solution for injection
ReFacto AF 500 IU powder and solvent for solution for injection
ReFacto AF 1000 IU powder and solvent for solution for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
ReFacto AF 250 IU powder and solvent for solution for injection
Each vial contains nominally 250 IU* moroctocog alfa**.
After reconstitution, each mL of solution contains approximately 62.5
IU moroctocog alfa.
ReFacto AF 500 IU powder and solvent for solution for injection
Each vial contains nominally 500 IU* moroctocog alfa**.
After reconstitution, each mL of solution contains approximately 125
IU moroctocog alfa.
ReFacto AF 1000 IU powder and solvent for solution for injection
Each vial contains nominally 1000 IU* moroctocog alfa**.
After reconstitution, each mL of solution contains approximately 250
IU moroctocog alfa.
* The potency (International Units) is determined using the European
Pharmacopoeia chromogenic
assay. The specific activity of ReFacto AF is 7,600-13,800 IU/mg
protein.
** Human coagulation factor VIII produced by recombinant DNA
technology in Chinese hamster
ovary (CHO) cells. Moroctocog alfa is a glycoprotein with 1438 amino
acids with a sequence that is
comparable to the 90 + 80 kDa form of factor VIII (i.e. B-domain
deleted) and similar
post-translational modifications to those of the plasma-derived
molecule.
The manufacturing process for ReFacto was modified to eliminate any
exogenous human- or
animal-derived protein in the cell culture process, purification, or
final formulation; and at the same
time the invented name was changed to ReFacto AF.
Excipient with known effect
After reconstitution, 1.27 mmol (29 mg) sodium per vial.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
ReFacto AF 250 IU, 500 IU, 1000 IU powder and solvent for solution for
injection
Powder and solvent for solution for injection
White to off-white cake/powder
Clear, colourless solvent
4.
CLINI