Advate 3,000unit powder and solvent for solution for infusion vials

Երկիր: Միացյալ Թագավորություն

Լեզու: անգլերեն

Աղբյուրը: MHRA (Medicines & Healthcare Products Regulatory Agency)

Ակտիվ բաղադրիչ:

Octocog alfa

Հասանելի է:

Baxalta UK Ltd

INN (Միջազգային անվանումը):

Octocog alfa

Դոզան:

3000unit

Դեղագործական ձեւ:

Powder and solvent for solution for infusion

Կառավարման երթուղին:

Intravenous

Դաս:

No Controlled Drug Status

Ռեկվիզորի տեսակը:

Valid as a prescribable product

Ապրանքի ամփոփագիր:

BNF: 02110000

Տեղեկատվական թերթիկ

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 allergic to mouse or hamster

Ապրանքի հատկությունները

OBJECT 1
ADVATE 250 IU, 500 IU, 1000 IU, 1500 IU, 2000
IU AND 3000 IU POWDER AND SOLVENT FOR SOLUTION
FOR INJECTION 5 ML WATER - BAXJECT II
Summary of Product Characteristics Updated 18-Dec-2017 | Shire
Pharmaceuticals Limited
1. Name of the medicinal product
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.
2. Qualitative and quantitative composition
Each vial contains nominally 250 IU, 500 IU, 1000 IU, 1500 IU, 2000
IU, 3000 IU human coagulation
factor VIII (rDNA), octocog alfa.
250 IU: ADVATE contains approximately 50 IU per ml of human
coagulation factor VIII (rDNA),
octocog alfa after reconstitution.
500 IU: ADVATE contains approximately 100 IU per ml of human
coagulation factor VIII (rDNA),
octocog alfa after reconstitution.
1000 IU: ADVATE contains approximately 200 IU per ml of human
coagulation factor VIII (rDNA),
octocog alfa after reconstitution.
1500 IU: ADVATE contains approximately 300 IU per ml of human
coagulation factor VIII (rDNA),
octocog alfa after reconstitution.
2000 IU: ADVATE contains approximately 400 IU per ml of human
coagulation factor VIII (rDNA),
octocog alfa after reconstitution.
3000 IU: ADVATE contains approximately 600 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 4,000-10,000 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,