Afstyla

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

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Patient Information leaflet Patient Information leaflet (PIL)
25-07-2022
Summary of Product characteristics Summary of Product characteristics (SPC)
25-07-2022
Public Assessment Report Public Assessment Report (PAR)
30-03-2017

Active ingredient:

lonoctocog alfa

Available from:

CSL Behring GmbH

ATC code:

B02BD02

INN (International Name):

lonoctocog alfa

Therapeutic group:

Antihemorrhagics

Therapeutic area:

Hemophilia A

Therapeutic indications:

Treatment and prophylaxis of bleeding in patients with haemophilia A (congenital factor VIII deficiency).Afstyla can be used for all age groups.

Product summary:

Revision: 10

Authorization status:

Authorised

Authorization date:

2017-01-04

Patient Information leaflet

                                44
B. PACKAGE LEAFLET
45
PACKAGE LEAFLET: INFORMATION FOR THE USER
AFSTYLA 250 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
AFSTYLA 500 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
AFSTYLA 1000 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
AFSTYLA 1500 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
AFSTYLA 2000 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
AFSTYLA 2500 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
AFSTYLA 3000 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
lonoctocog alfa (recombinant, single-chain coagulation factor VIII)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU OR YOUR CHILD 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, ask your doctor, pharmacist or nurse.
•
This medicine has been prescribed for you
OR YOUR CHILD
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, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
:
1.
What AFSTYLA is and what it is used for
2.
What you need to know before you
OR YOUR CHILD
use AFSTYLA
3.
How to use AFSTYLA
4.
Possible side effects
5.
How to store AFSTYLA
6.
Contents of the pack and other information
1.
WHAT AFSTYLA IS AND WHAT IT IS USED FOR
AFSTYLA is a human clotting (coagulation) factor VIII product that is
produced by recombinant
DNA technology. The active substance in AFSTYLA is lonoctocog alfa.
AFSTYLA is used to treat and prevent bleeding episodes in patients
with haemophilia A (inborn factor
VIII deficiency). Factor VIII is a protein needed for blood to clot.
Patients with haemophilia A lack
this factor, so blood does not clot as quickly as it should and they
have an increased tendency to bleed.
AFSTYLA works by replacing the missing factor VIII in haemophilia A
patients enabling their blood
to clot normally.
AFSTYLA can be 
                                
                                Read the complete document

Summary of Product characteristics

                                1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
AFSTYLA 250 IU powder and solvent for solution for injection
AFSTYLA 500 IU powder and solvent for solution for injection
AFSTYLA 1000 IU powder and solvent for solution for injection
AFSTYLA 1500 IU powder and solvent for solution for injection
AFSTYLA 2000 IU powder and solvent for solution for injection
AFSTYLA 2500 IU powder and solvent for solution for injection
AFSTYLA 3000 IU powder and solvent for solution for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
AFSTYLA 250 IU powder and solvent for solution for injection
Each vial contains nominally 250 IU recombinant, single-chain
coagulation factor VIII
_ _
(rVIII-
SingleChain, INN = lonoctocog alfa). After reconstitution with 2.5 ml
water for injections the
solution contains 100 IU/ml of rVIII-SingleChain.
AFSTYLA 500 IU powder and solvent for solution for injection
Each vial contains nominally 500 IU recombinant, single-chain
coagulation factor VIII
_ _
(rVIII-
SingleChain, INN = lonoctocog alfa). After reconstitution with 2.5 ml
water for injections the
solution contains 200 IU/ml of rVIII-SingleChain.
AFSTYLA 1000 IU powder and solvent for solution for injection
Each vial contains nominally 1000 IU recombinant, single-chain
coagulation factor VIII
_ _
(rVIII-
SingleChain, INN = lonoctocog alfa). After reconstitution with 2.5 ml
water for injections the
solution contains 400 IU/ml of rVIII-SingleChain.
AFSTYLA 1500 IU powder and solvent for solution for injection
Each vial contains nominally 1500 IU recombinant, single-chain
coagulation factor VIII
_ _
(rVIII-
SingleChain, INN = lonoctocog alfa). When reconstituted with 5 ml
water for injections the
solution contains 300 IU/ml of rVIII-SingleChain.
AFSTYLA 2000 IU powder and solvent for solution for injection
Each vial contains nominally 2000 IU recombinant, single-chain
coagulation factor VIII
_ _
(rVIII-
SingleChain, INN = lonoctocog alfa). When reconstituted with 5 ml
water for injections the
solution contains 400 IU
                                
                                Read the complete document

Similar products

Active ingredient lonoctocog alfa

lonoctocog alfa

ATC code B02BD02

B02BD02

Marketed by CSL Behring GmbH

CSL Behring GmbH

INN (International Name) lonoctocog alfa

lonoctocog alfa

Documents in other languages

Patient Information leaflet Patient Information leaflet Bulgarian 25-07-2022
Summary of Product characteristics Summary of Product characteristics Bulgarian 25-07-2022
Public Assessment Report Public Assessment Report Bulgarian 30-03-2017
Patient Information leaflet Patient Information leaflet Spanish 25-07-2022
Summary of Product characteristics Summary of Product characteristics Spanish 25-07-2022
Public Assessment Report Public Assessment Report Spanish 30-03-2017
Patient Information leaflet Patient Information leaflet Czech 25-07-2022
Summary of Product characteristics Summary of Product characteristics Czech 25-07-2022
Public Assessment Report Public Assessment Report Czech 30-03-2017
Patient Information leaflet Patient Information leaflet Danish 25-07-2022
Summary of Product characteristics Summary of Product characteristics Danish 25-07-2022
Public Assessment Report Public Assessment Report Danish 30-03-2017
Patient Information leaflet Patient Information leaflet German 25-07-2022
Summary of Product characteristics Summary of Product characteristics German 25-07-2022
Public Assessment Report Public Assessment Report German 30-03-2017
Patient Information leaflet Patient Information leaflet Estonian 25-07-2022
Summary of Product characteristics Summary of Product characteristics Estonian 25-07-2022
Public Assessment Report Public Assessment Report Estonian 30-03-2017
Patient Information leaflet Patient Information leaflet Greek 25-07-2022
Summary of Product characteristics Summary of Product characteristics Greek 25-07-2022
Public Assessment Report Public Assessment Report Greek 30-03-2017
Patient Information leaflet Patient Information leaflet French 25-07-2022
Summary of Product characteristics Summary of Product characteristics French 25-07-2022
Public Assessment Report Public Assessment Report French 30-03-2017
Patient Information leaflet Patient Information leaflet Italian 25-07-2022
Summary of Product characteristics Summary of Product characteristics Italian 25-07-2022
Public Assessment Report Public Assessment Report Italian 30-03-2017
Patient Information leaflet Patient Information leaflet Latvian 25-07-2022
Summary of Product characteristics Summary of Product characteristics Latvian 25-07-2022
Public Assessment Report Public Assessment Report Latvian 30-03-2017
Patient Information leaflet Patient Information leaflet Lithuanian 25-07-2022
Summary of Product characteristics Summary of Product characteristics Lithuanian 25-07-2022
Public Assessment Report Public Assessment Report Lithuanian 30-03-2017
Patient Information leaflet Patient Information leaflet Hungarian 25-07-2022
Summary of Product characteristics Summary of Product characteristics Hungarian 25-07-2022
Public Assessment Report Public Assessment Report Hungarian 30-03-2017
Patient Information leaflet Patient Information leaflet Maltese 25-07-2022
Summary of Product characteristics Summary of Product characteristics Maltese 25-07-2022
Public Assessment Report Public Assessment Report Maltese 30-03-2017
Patient Information leaflet Patient Information leaflet Dutch 25-07-2022
Summary of Product characteristics Summary of Product characteristics Dutch 25-07-2022
Public Assessment Report Public Assessment Report Dutch 30-03-2017
Patient Information leaflet Patient Information leaflet Polish 25-07-2022
Summary of Product characteristics Summary of Product characteristics Polish 25-07-2022
Public Assessment Report Public Assessment Report Polish 30-03-2017
Patient Information leaflet Patient Information leaflet Portuguese 25-07-2022
Summary of Product characteristics Summary of Product characteristics Portuguese 25-07-2022
Public Assessment Report Public Assessment Report Portuguese 30-03-2017
Patient Information leaflet Patient Information leaflet Romanian 25-07-2022
Summary of Product characteristics Summary of Product characteristics Romanian 25-07-2022
Public Assessment Report Public Assessment Report Romanian 30-03-2017
Patient Information leaflet Patient Information leaflet Slovak 25-07-2022
Summary of Product characteristics Summary of Product characteristics Slovak 25-07-2022
Public Assessment Report Public Assessment Report Slovak 30-03-2017
Patient Information leaflet Patient Information leaflet Slovenian 25-07-2022
Summary of Product characteristics Summary of Product characteristics Slovenian 25-07-2022
Public Assessment Report Public Assessment Report Slovenian 30-03-2017
Patient Information leaflet Patient Information leaflet Finnish 25-07-2022
Summary of Product characteristics Summary of Product characteristics Finnish 25-07-2022
Public Assessment Report Public Assessment Report Finnish 30-03-2017
Patient Information leaflet Patient Information leaflet Swedish 25-07-2022
Summary of Product characteristics Summary of Product characteristics Swedish 25-07-2022
Public Assessment Report Public Assessment Report Swedish 30-03-2017
Patient Information leaflet Patient Information leaflet Norwegian 25-07-2022
Summary of Product characteristics Summary of Product characteristics Norwegian 25-07-2022
Patient Information leaflet Patient Information leaflet Icelandic 25-07-2022
Summary of Product characteristics Summary of Product characteristics Icelandic 25-07-2022
Patient Information leaflet Patient Information leaflet Croatian 25-07-2022
Summary of Product characteristics Summary of Product characteristics Croatian 25-07-2022
Public Assessment Report Public Assessment Report Croatian 30-03-2017

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