Hemlibra

Maa: Euroopan unioni

Kieli: englanti

Lähde: EMA (European Medicines Agency)

Aktiivinen ainesosa:

Emicizumab

Saatavilla:

Roche Registration Limited

ATC-koodi:

B02BX06

INN (Kansainvälinen yleisnimi):

emicizumab

Terapeuttinen ryhmä:

Antihemorrhagics

Terapeuttinen alue:

Hemophilia A

Käyttöaiheet:

Hemlibra is indicated for routine prophylaxis of bleeding episodes in patients with haemophilia A (congenital factor VIII deficiency):with factor VIII inhibitorswithout factor VIII inhibitors who have:severe disease (FVIII < 1%)moderate disease (FVIII ≥ 1% and ≤ 5%) with severe bleeding phenotype.Hemlibra can be used in all age groups.

Tuoteyhteenveto:

Revision: 15

Valtuutuksen tilan:

Authorised

Valtuutus päivämäärä:

2018-02-23

Pakkausseloste

58
B. PACKAGE LEAFLET
59
PACKAGE LEAFLET: INFORMATION FOR THE USER
HEMLIBRA 30 MG/ML SOLUTION FOR INJECTION
emicizumab
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.
In addition to this leaflet, your doctor will give you a patient card,
which contains important safety
information that you need to be aware of. Keep this patient card with
you.
WHAT IS IN THIS LEAFLET
1.
What Hemlibra is and what it is used for
2.
What you need to know before you use Hemlibra
3.
How to use Hemlibra
4.
Possible side effects
5.
How to store Hemlibra
6.
Contents of the pack and other information
7.
Instructions for use
1.
WHAT HEMLIBRA IS AND WHAT IT IS USED FOR
WHAT HEMLIBRA IS
Hemlibra contains the active substance “emicizumab”. This belongs
to a group of medicines called
“monoclonal antibodies”. Monoclonal antibodies are a type of
protein that recognise and bind to a
target in the body.
WHAT HEMLIBRA IS USED FOR
Hemlibra is a medicine used for treating patients of all ages with
haemophilia A (congenital
factor VIII deficiency):
●
who have developed factor VIII inhibitors
●
who have not developed factor VIII inhibitors with:
-
severe disease (the factor VIII blood level is less than 1%)
-
moderate disease (the factor VIII blood level is from 1% to 5%) with
severe bleeding
phenotype.
Haemophilia A is an inherited condition caused by a lack of factor
VIII, an essential substance
required for blood to clot and stop any bleeding.
The medicine prevents bleeding or reduces bleeding episodes in people
with this condition

Valmisteyhteenveto

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Hemlibra 30 mg/mL solution for injection
Hemlibra 150 mg/mL solution for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Hemlibra 30 mg/mL solution for injection
Each mL of solution contains 30 mg of emicizumab*
Each vial of 0.4 mL contains 12 mg of emicizumab at a concentration of
30 mg/mL.
Each vial of 1 mL contains 30 mg of emicizumab at a concentration of
30 mg/mL.
Hemlibra 150 mg/mL solution for injection
Each mL of solution contains 150 mg of emicizumab*
Each vial of 0.4 mL contains 60 mg of emicizumab at a concentration of
150 mg/mL.
Each vial of 0.7 mL contains 105 mg of emicizumab at a concentration
of 150 mg/mL.
Each vial of 1 mL contains 150 mg of emicizumab at a concentration of
150 mg/mL.
Each vial of 2 mL contains 300 mg of emicizumab at a concentration of
150 mg/mL.
* Emicizumab is a humanised monoclonal modified immunoglobulin G4
(IgG4) antibody produced
using recombinant DNA technology in mammalian Chinese Hamster Ovary
(CHO) cells
For the full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Solution for injection.
Colourless to slightly yellow solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Hemlibra is indicated for routine prophylaxis of bleeding episodes in
patients with haemophilia A
(congenital factor VIII deficiency):
●
with factor VIII inhibitors
●
without factor VIII inhibitors who have:
-
severe disease (FVIII < 1%)
-
moderate disease (FVIII ≥ 1% and ≤ 5%) with severe bleeding
phenotype.
Hemlibra can be used in all age groups.
3
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Treatment should be initiated under the supervision of a physician
experienced in the treatment of
haemophilia and/or bleeding disorders.
Posology
Treatment (including routine prophylaxis) with bypassing agents (e.g.
activated prothrombin complex
concentrate [aPCC] and activated recombinant human FVII [rFVIIa])
should be discontinued the day
before starting Hemlibra therapy (see section 4.4).
Factor VIII