Hemlibra 105mg0.7ml solution for injection vials

Land: Storbritannien

Sprog: engelsk

Kilde: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktiv bestanddel:

Emicizumab

Tilgængelig fra:

Roche Products Ltd

ATC-kode:

B02BX06

INN (International Name):

Emicizumab

Dosering:

150mg/1ml

Lægemiddelform:

Solution for injection

Indgivelsesvej:

Subcutaneous

Klasse:

No Controlled Drug Status

Recept type:

Valid as a prescribable product

Produkt oversigt:

BNF: ; GTIN: 05000471007572

Indlægsseddel

1
uk-ie-mt-pil-hemlibra-clean-180504-150mg-ml-sol-inj
PACKAGE LEAFLET: INFORMATION FOR THE USER
HEMLIBRA 150 MG/ML SOLUTION FOR INJECTION
EMICIZUMAB
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 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 who have developed
factor VIII inhibitors
The medicine prevents bleeding or reduces bleeding episodes in people
with this condition.
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.
HOW HEMLIBRA WORKS
Patients with haemophilia A are normally treated with infusion (drip)
of replacement factor VIII, but
some patients develop factor VIII inhibitors (antibodie

Produktets egenskaber

OBJECT 1
HEMLIBRA 30 MG/ML SOLUTION FOR INJECTION
Summary of Product Characteristics Updated 10-May-2018 | Roche
Products Limited
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
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 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.
* produced by recombinant DNA technology using mammalian Chinese
Hamster Ovary (CHO) cell
culture
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 with
factor VIII inhibitors.
Hemlibra can be used in all age groups.
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.
aPCC and rFVIIa) should be
discontinued the day before starting Hemlibra therapy (see section
4.4).
The recommended dose is 3 mg/kg once weekly for the first 4 weeks
(loading dose), followed by 1.5
mg/kg once weekly (maintenance dose), administered as a subcutaneous
injection.
The