Icatibant Accord

Land: Den europeiske union

Språk: engelsk

Kilde: EMA (European Medicines Agency)

Aktiv ingrediens:

icatibant acetate

Tilgjengelig fra:

Accord Healthcare S.L.U.

ATC-kode:

B06AC02

INN (International Name):

icatibant

Terapeutisk gruppe:

Other hematological agents

Terapeutisk område:

Angioedemas, Hereditary

Indikasjoner:

Icatibant Accord 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.

Autorisasjon status:

Authorised

Autorisasjon dato:

2021-07-16

Informasjon til brukeren

23
B.
PACKAGE LEAFLET
24
PACKAGE LEAFLET: INFORMATION FOR THE USER
ICATIBANT ACCORD 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 Icatibant Accord is and what it is used for
2.
What you need to know before you use Icatibant Accord
3.
How to use Icatibant Accord
4.
Possible side effects
5.
How to store Icatibant Accord
6.
Contents of the pack and other information
1.
WHAT ICATIBANT ACCORD IS AND WHAT IT IS USED FOR
Icatibant Accord contains the active substance icatibant.
Icatibant Accord 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.
Icatibant Accord blocks the activity of bradykinin and therefore ends
the further progression of the
symptoms.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE I C A T IBA NT A C C O R D
DO NOT USE ICATIBANT ACCORD 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 Icatibant Accord:
-
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 Icatibant Accord are similar
to the symptoms of your disease.
Tell your doctor immediately if you notice that your symptoms of the
attack get wor

Preparatomtale

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Icatibant Accord 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.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection.
The solution is a clear and colourless liquid, practically free from
foreign particles.
pH: 5.0 to 6.0
Osmolality: 280 to 340 mOsmol/kg
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Icatibant Accord 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
Icatibant Accord is intended for use under the guidance of a
healthcare professional.
Posology
_Adults_
_ _
The recommended dose for adults is a single subcutaneous injection of
Icatibant Accord 30 mg.
In the majority of cases a single injection of Icatibant Accord is
sufficient to treat an attack. In case of
insufficient relief or recurrence of symptoms, a second injection of
Icatibant Accord can be
administered after 6 hours. If the second injection produces
insufficient relief or a recurrence of
symptoms is observed, a third injection of Icatibant Accord can be
administered after a further 6
hours. No more than 3 injections of Icatibant Accord should be
administered in a 24 hour period.
In the clinical trials, not more than 8 injections of Icatibant Accord
per month have been administered.
_Paediatric population_
_ _
The recommended dose of Icatibant Accord based on body weight in
children and adolescents (aged 2
to 17 years) is provided in table 1 below.
3
TABLE 1: DOSE 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