Firazyr

Riik: Euroopa Liit

keel: inglise

Allikas: EMA (European Medicines Agency)

Toimeaine:

icatibant

Saadav alates:

Takeda Pharmaceuticals International AG

ATC kood:

B06AC02

INN (Rahvusvaheline Nimetus):

icatibant

Terapeutiline rühm:

Cardiac therapy

Terapeutiline ala:

Angioedemas, Hereditary

Näidustused:

Firazyr is indicated for symptomatic treatment of acute attacks of hereditary angioedema (HAE) in adults (with C1-esterase-inhibitor deficiency).

Toote kokkuvõte:

Revision: 23

Volitamisolek:

Authorised

Loa andmise kuupäev:

2008-07-11

Infovoldik

27
B. PACKAGE LEAFLET
28
PACKAGE LEAFLET: INFORMATION FOR THE USER
FIRAZYR 30 MG SOLUTION FOR INJECTION PRE-FILLED SYRINGE
icatibant
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 or pharmacist.
-
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 or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1.
What Firazyr is and what it is used for
2.
What you need to know before you use Firazyr
3.
How to use Firazyr
4.
Possible side effects
5.
How to store Firazyr
6.
Contents of the pack and other information
1.
WHAT FIRAZYR IS AND WHAT IT IS USED FOR
Firazyr contains the active substance icatibant.
Firazyr is used for treating the symptoms of hereditary angioedema
(HAE) in adults, adolescents and
children aged 2 years and older.
In HAE levels of a substance in your bloodstream called bradykinin are
increased and this leads to
symptoms like swelling, pain, nausea, and diarrhoea.
Firazyr blocks the activity of bradykinin and therefore ends the
further progression of the symptoms.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE FIRAZYR
DO NOT USE FIRAZYR
-
If you are allergic to icatibant, or any of the other ingredients of
this medicine (listed in
section 6).
WARNINGS AND PRECAUTIONS
Talk to your doctor before taking Firazyr:
-
if you are suffering from angina (reduced blood flow to the heart
muscle)
-
if you have recently suffered a stroke
Some of the side effects connected with Firazyr are similar to the
symptoms of your disease. Tell your
doctor immediately if you notice that your symptoms of the attack get
worse after you received Firazyr
29
In addition:
-
You or your caregiver must be trained on subcutaneous (under the skin)
inject

Toote omadused

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Firazyr 30 mg solution for injection in pre-filled syringe
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each pre-filled syringe of 3 ml contains icatibant acetate equivalent
to 30 mg icatibant.
Each ml of the solution contains 10 mg of icatibant.
Excipient(s) with known effect
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection.
The solution is a clear and colourless liquid.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Firazyr is indicated for symptomatic treatment of acute attacks of
hereditary angioedema (HAE) in
adults, adolescents and children aged 2 years and older, with
C1-esterase-inhibitor deficiency.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Firazyr is intended for use under the guidance of a healthcare
professional.
Posology
Adults
The recommended dose for adults is a single subcutaneous injection of
Firazyr 30 mg.
In the majority of cases a single injection of Firazyr is sufficient
to treat an attack. In case of
insufficient relief or recurrence of symptoms, a second injection of
Firazyr can be administered after
6 hours. If the second injection produces insufficient relief or a
recurrence of symptoms is observed, a
third injection of Firazyr can be administered after a further 6
hours. No more than 3 injections of
Firazyr should be administered in a 24 hour period.
In the clinical trials, not more than 8 injections of Firazyr per
month have been administered.
Paediatric population
The recommended dose of Firazyr based on body weight in children and
adolescents (aged 2 to 17
years) is provided in table 1 below.
3
TABLE 1: DOSAGE REGIMEN FOR PAEDIATRIC PATIENTS
BODY WEIGHT
DOSE (INJECTION VOLUME)
12 kg to 25 kg
10 mg (1.0 ml)
26 kg to 40 kg
15 mg (1.5 ml)
41 kg to 50 kg
20 mg (2.0 ml)
51 kg to 65 kg
25 mg (2.5 ml)
>65 kg
30 mg (3.0 ml)
In the clinical trial, not more than 1 injection of Firazyr per HAE
attack has been administered.
No dosage regimen for children aged less tha