ReFacto AF 250unit powder and solvent for solution for injection pre-filled syringes

Země: Velká Británie

Jazyk: angličtina

Zdroj: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktivní složka:

Moroctocog alfa

Dostupné s:

Pfizer Ltd

INN (Mezinárodní Name):

Moroctocog alfa

Dávkování:

250unit

Léková forma:

Powder and solvent for solution for injection

Podání:

Intravenous

Třída:

No Controlled Drug Status

Druh předpisu:

Valid as a prescribable product

Přehled produktů:

BNF: ; GTIN: 5013457021783

Informace pro uživatele

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
REFACTO AF 250 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION IN
PRE-FILLED SYRINGE
REFACTO AF 500 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION IN
PRE-FILLED SYRINGE
REFACTO AF 1000 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION IN
PRE-FILLED SYRINGE
REFACTO AF 2000 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION IN
PRE-FILLED SYRINGE
REFACTO AF 3000 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION IN
PRE-FILLED SYRINGE
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 thi

Charakteristika produktu

OBJECT 1
REFACTO AF 250 IU POWDER AND SOLVENT FOR
SOLUTION FOR INJECTION
Summary of Product Characteristics Updated 23-Feb-2018 | Pfizer
Limited
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
ReFacto AF 2000 IU powder and solvent for solution for injection
ReFacto AF 250 IU powder and solvent for solution for injection in
pre-filled syringe
ReFacto AF 500 IU powder and solvent for solution for injection in
pre-filled syringe
ReFacto AF 1000 IU powder and solvent for solution for injection in
pre-filled syringe
ReFacto AF 2000 IU powder and solvent for solution for injection in
pre-filled syringe
ReFacto AF 3000 IU powder and solvent for solution for injection in
pre-filled syringe
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.
ReFacto AF 2000 IU powder and solvent for solution for injection
Each vial contains nominally 2000 IU* moroctocog alfa**.
After reconstitution, each mL of solution contains approximately 500
IU moroctocog alfa.
ReFacto AF 250 IU powder and solvent for solution for injection in
pre-filled syringe
Each pre-filled syringe 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 solutio