Elocta

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

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Patient Information leaflet Patient Information leaflet (PIL)
16-05-2018
Summary of Product characteristics Summary of Product characteristics (SPC)
16-05-2018
Public Assessment Report Public Assessment Report (PAR)
10-12-2015

Active ingredient:

efmoroctocog alfa

Available from:

Swedish Orphan Biovitrum AB (publ)

ATC code:

B02BD02

INN (International Name):

efmoroctocog alfa

Therapeutic group:

Antihemorrhagics

Therapeutic area:

Hemophilia A

Therapeutic indications:

Treatment and prophylaxis of bleeding in patients with haemophilia A (congenital factor VIII deficiency).

Authorization status:

Authorised

Authorization date:

2015-11-19

Patient Information leaflet

                                25
B. PACKAGE LEAFLET
26
PACKAGE LEAFLET: INFORMATION FOR THE USER
ELOCTA 250 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
ELOCTA 500 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
ELOCTA 750 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
ELOCTA 1000 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
ELOCTA 1500 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
ELOCTA 2000 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
ELOCTA 3000 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
efmoroctocog alfa (recombinant coagulation factor VIII)
This medicine is subject to additional monitoring. This will allow
quick identification of new safety
information. You can help by reporting any side effects you may get.
See the end of section 4 for how to
report side effects.
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, pharmacist or
nurse.
•
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, pharmacist or nurse.
This includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What ELOCTA is and what it is used for
2.
What you need to know before you use ELOCTA
3.
How to use ELOCTA
4.
Possible side effects
5.
How to store ELOCTA
6.
Contents of the pack and other information
7.
Instructions for preparation and administration
1.
WHAT ELOCTA IS AND WHAT IT IS USED FOR
ELOCTA contains the active substance efmoroctocog alfa, a recombinant
coagulation factor VIII, Fc fusion
protein. Factor VIII is a protein produced naturally in the body and
is necessary for the blood to form clots
and stop bleeding.
ELOCTA is a medicine used for the treatment and prevention of bleeding
in all age groups of patients with
haemophilia A (inherited bleeding disorder caus
                                
                                Read the complete document

Summary of Product characteristics

                                ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
This medicinal product is subject to additional monitoring. This will
allow quick identification of new
safety information. Healthcare professionals are asked to report any
suspected adverse reactions. See section
4.8 for how to report adverse reactions.
1.
NAME OF THE MEDICINAL PRODUCT
ELOCTA 250 IU powder and solvent for solution for injection
ELOCTA 500 IU powder and solvent for solution for injection
ELOCTA 750 IU powder and solvent for solution for injection
ELOCTA 1000 IU powder and solvent for solution for injection
ELOCTA 1500 IU powder and solvent for solution for injection
ELOCTA 2000 IU powder and solvent for solution for injection
ELOCTA 3000 IU powder and solvent for solution for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
ELOCTA 250 IU powder and solvent for solution for injection
Each vial contains nominally 250 IU efmoroctocog alfa. After
reconstitution, each mL of solution for
injection contains approximately 83 IU efmoroctocog alfa.
ELOCTA 500 IU powder and solvent for solution for injection
Each vial contains nominally 500 IU efmoroctocog alfa. After
reconstitution, each mL of solution for
injection contains approximately 167 IU efmoroctocog alfa.
ELOCTA 750 IU powder and solvent for solution for injection
Each vial contains nominally 750 IU efmoroctocog alfa. After
reconstitution, each mL of solution for
injection contains approximately 250 IU efmoroctocog alfa.
ELOCTA 1000 IU powder and solvent for solution for injection
Each vial contains nominally 1000 IU efmoroctocog alfa. After
reconstitution, each mL of solution for
injection contains approximately 333 IU efmoroctocog alfa.
ELOCTA 1500 IU powder and solvent for solution for injection
Each vial contains nominally 1500 IU efmoroctocog alfa. After
reconstitution, each mL of solution for
injection contains approximately 500 IU efmoroctocog alfa.
ELOCTA 2000 IU powder and solvent for solution for injection
Each vial contains nominally 2000 IU efmoroctocog alfa. After
reconstitution, each 
                                
                                Read the complete document

Similar products

Active ingredient efmoroctocog alfa

efmoroctocog alfa

ATC code B02BD02

B02BD02

Marketed by Swedish Orphan Biovitrum AB (publ)

Swedish Orphan Biovitrum AB (publ)

INN (International Name) efmoroctocog alfa

efmoroctocog alfa

Documents in other languages

Patient Information leaflet Patient Information leaflet Bulgarian 26-02-2021
Summary of Product characteristics Summary of Product characteristics Bulgarian 26-02-2021
Public Assessment Report Public Assessment Report Bulgarian 12-12-2018
Patient Information leaflet Patient Information leaflet Spanish 26-02-2021
Summary of Product characteristics Summary of Product characteristics Spanish 26-02-2021
Public Assessment Report Public Assessment Report Spanish 12-12-2018
Patient Information leaflet Patient Information leaflet Czech 26-02-2021
Summary of Product characteristics Summary of Product characteristics Czech 26-02-2021
Public Assessment Report Public Assessment Report Czech 12-12-2018
Patient Information leaflet Patient Information leaflet Danish 26-02-2021
Summary of Product characteristics Summary of Product characteristics Danish 26-02-2021
Public Assessment Report Public Assessment Report Danish 12-12-2018
Patient Information leaflet Patient Information leaflet German 26-02-2021
Summary of Product characteristics Summary of Product characteristics German 26-02-2021
Public Assessment Report Public Assessment Report German 12-12-2018
Patient Information leaflet Patient Information leaflet Estonian 26-02-2021
Summary of Product characteristics Summary of Product characteristics Estonian 26-02-2021
Public Assessment Report Public Assessment Report Estonian 12-12-2018
Patient Information leaflet Patient Information leaflet Greek 26-02-2021
Summary of Product characteristics Summary of Product characteristics Greek 26-02-2021
Public Assessment Report Public Assessment Report Greek 12-12-2018
Patient Information leaflet Patient Information leaflet French 26-02-2021
Summary of Product characteristics Summary of Product characteristics French 26-02-2021
Public Assessment Report Public Assessment Report French 12-12-2018
Patient Information leaflet Patient Information leaflet Italian 26-02-2021
Summary of Product characteristics Summary of Product characteristics Italian 26-02-2021
Public Assessment Report Public Assessment Report Italian 12-12-2018
Patient Information leaflet Patient Information leaflet Latvian 26-02-2021
Summary of Product characteristics Summary of Product characteristics Latvian 26-02-2021
Public Assessment Report Public Assessment Report Latvian 12-12-2018
Patient Information leaflet Patient Information leaflet Lithuanian 26-02-2021
Summary of Product characteristics Summary of Product characteristics Lithuanian 26-02-2021
Public Assessment Report Public Assessment Report Lithuanian 12-12-2018
Patient Information leaflet Patient Information leaflet Hungarian 26-02-2021
Summary of Product characteristics Summary of Product characteristics Hungarian 26-02-2021
Public Assessment Report Public Assessment Report Hungarian 12-12-2018
Patient Information leaflet Patient Information leaflet Maltese 26-02-2021
Summary of Product characteristics Summary of Product characteristics Maltese 26-02-2021
Public Assessment Report Public Assessment Report Maltese 12-12-2018
Patient Information leaflet Patient Information leaflet Dutch 26-02-2021
Summary of Product characteristics Summary of Product characteristics Dutch 26-02-2021
Public Assessment Report Public Assessment Report Dutch 12-12-2018
Patient Information leaflet Patient Information leaflet Polish 26-02-2021
Summary of Product characteristics Summary of Product characteristics Polish 26-02-2021
Public Assessment Report Public Assessment Report Polish 12-12-2018
Patient Information leaflet Patient Information leaflet Portuguese 26-02-2021
Summary of Product characteristics Summary of Product characteristics Portuguese 26-02-2021
Public Assessment Report Public Assessment Report Portuguese 12-12-2018
Patient Information leaflet Patient Information leaflet Romanian 26-02-2021
Summary of Product characteristics Summary of Product characteristics Romanian 26-02-2021
Public Assessment Report Public Assessment Report Romanian 12-12-2018
Patient Information leaflet Patient Information leaflet Slovak 26-02-2021
Summary of Product characteristics Summary of Product characteristics Slovak 26-02-2021
Public Assessment Report Public Assessment Report Slovak 12-12-2018
Patient Information leaflet Patient Information leaflet Slovenian 26-02-2021
Summary of Product characteristics Summary of Product characteristics Slovenian 26-02-2021
Public Assessment Report Public Assessment Report Slovenian 12-12-2018
Patient Information leaflet Patient Information leaflet Finnish 26-02-2021
Summary of Product characteristics Summary of Product characteristics Finnish 26-02-2021
Public Assessment Report Public Assessment Report Finnish 12-12-2018
Patient Information leaflet Patient Information leaflet Swedish 26-02-2021
Summary of Product characteristics Summary of Product characteristics Swedish 26-02-2021
Public Assessment Report Public Assessment Report Swedish 12-12-2018
Patient Information leaflet Patient Information leaflet Norwegian 26-02-2021
Summary of Product characteristics Summary of Product characteristics Norwegian 26-02-2021
Patient Information leaflet Patient Information leaflet Icelandic 26-02-2021
Summary of Product characteristics Summary of Product characteristics Icelandic 26-02-2021
Patient Information leaflet Patient Information leaflet Croatian 26-02-2021
Summary of Product characteristics Summary of Product characteristics Croatian 26-02-2021
Public Assessment Report Public Assessment Report Croatian 12-12-2018

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