Icatibant Aguettant 30 mg solution for injection in pre-filled syringe

Pays: Irlande

Langue: anglais

Source: HPRA (Health Products Regulatory Authority)

Ingrédients actifs:

Icatibant Acetate

Disponible depuis:

Laboratoire AGUETTANT

Code ATC:

B06AC02

DCI (Dénomination commune internationale):

Icatibant Acetate

forme pharmaceutique:

Solution for injection in pre-filled syringe

Domaine thérapeutique:

icatibant

Statut de autorisation:

Marketed

Date de l'autorisation:

2022-02-18

Notice patient

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
ICATIBANT AGUETTANT 30 MG SOLUTION FOR INJECTION IN 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 Aguettant is and what it is used for
2.
What you need to know before you use Icatibant Aguettant
3.
How to use Icatibant Aguettant
4.
Possible side effects
5.
How to store Icatibant Aguettant
6.
Contents of the pack and other information
1.
WHAT ICATIBANT AGUETTANT IS AND WHAT IT IS USED FOR
Icatibant Aguettant contains the active substance icatibant.
Icatibant Aguettant 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 Aguettant blocks the activity of bradykinin and therefore
ends the further progression of the
symptoms.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE ICATIBANT AGUETTANT
DO NOT USE ICATIBANT AGUETTANT
-
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 Aguettant:
-
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 Aguettant are
similar to the symptoms of your
disease. Tell your doctor immediately if you notice that your symptoms
of the att

Résumé des caractéristiques du produit

Health Products Regulatory Authority
23 February 2022
CRN009XN9
Page 1 of 10
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Icatibant Aguettant 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 (as acetate).
Each ml of the solution contains 10 mg of icatibant (as acetate).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection.
The solution is a clear and colourless liquid.
pH 5.0 - 7.0
Osmolality of the solution is about 300 mOsm/kg
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Icatibant Aguettant 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 Aguettant 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 Aguettant 30 mg.
In the majority of cases a single injection of Icatibant Aguettant is
sufficient to treat an attack. In case of insufficient relief or
recurrence of symptoms, a second injection of Icatibant Aguettant 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 Aguettant can be
administered after a further 6 hours. No more than 3 injections of
Icatibant Aguettant should be administered in a 24 hour
period.
In the clinical trials, not more than 8 injections of icatibant per
month have been administered.
_Paediatric population _
The recommended dose of Icatibant Aguettant based on body weight in
children and adolescents (aged 2 to 17 years) is
provided in table 1 below.
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 m