Icatibant 30 mg solution for injection in pre-filled syringe

Šalis: Airija

kalba: anglų

Šaltinis: HPRA (Health Products Regulatory Authority)

Veiklioji medžiaga:

Icatibant Acetate

Prieinama:

Fresenius Kabi Deutschland GmbH

ATC kodas:

B06AC02

INN (Tarptautinis Pavadinimas):

Icatibant Acetate

Vaisto forma:

Solution for injection in pre-filled syringe

Gydymo sritis:

icatibant

Leidimo data:

2022-03-11

Pakuotės lapelis

IE-UK-PIL-Icatibant-30mg PFS-v000
1
PACKAGE LEAFLET: INFORMATION FOR THE USER
ICATIBANT 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 is and what it is used for
2.
What you need to know before you use Icatibant
3.
How to use Icatibant
4.
Possible side effects
5.
How to store Icatibant
6.
Contents of the pack and other information
1.
WHAT ICATIBANT IS AND WHAT IT IS USED FOR
Icatibant contains the active substance icatibant.
Icatibant 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 blocks the activity of bradykinin and therefore ends the
further progression of the symptoms.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE ICATIBANT
DO NOT USE ICATIBANT
-
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:
-
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 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
Icatibant.
In addition:
-
You or your caregiver must be trained

Prekės savybės

Health Products Regulatory Authority
11 March 2022
CRN009TP6
Page 1 of 10
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Icatibant 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 in pre-filled syringe.
The solution is a clear and colourless liquid.
pH of solution 5.0 - 6.0.
Osmolality of solution 270 – 330 mOsm.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Icatibant 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 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 30 mg.
In the majority of cases a single injection of Icatibant is sufficient
to treat an attack. In case of insufficient relief or recurrence of
symptoms, a second injection of Icatibant 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 can be administered after a further 6 hours. No more
than 3 injections of Icatibant 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 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 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 t