Idisan 30mg solution for injection in a pre-filled syringe

Nazione: Malta

Lingua: inglese

Fonte: Medicines Authority

Principio attivo:

ICATIBANT

Commercializzato da:

Adalvo Limited Malta Life Sciences Park, Building 1, Level 4 Sir Temi Zammit San Gwann Industrial Est, SGN 3000 San Gwann, Malta

Codice ATC:

B06AC02

INN (Nome Internazionale):

ICATIBANT 10 mg/ml

Forma farmaceutica:

SOLUTION FOR INJECTION IN A PRE-FILLED SYRINGE

Composizione:

ICATIBANT 10 mg/ml

Tipo di ricetta:

POM

Area terapeutica:

OTHER HEMATOLOGICAL AGENTS

Dettagli prodotto:

Licence number in the source country: NOT APPLICAPABLE

Stato dell'autorizzazione:

Authorised

Data dell'autorizzazione:

2021-10-18

Foglio illustrativo

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PACKAGE LEAFLET
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PACKAGE LEAFLET: INFORMATION FOR THE USER
IDISAN 30 MG SOLUTION FOR INJECTION IN A 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 Idisan 30 mg is and what it is used for
2.
What you need to know before you use Idisan 30 mg
3.
How to use Idisan 30 mg
4.
Possible side effects
5.
How to store Idisan 30 mg
6.
Contents of the pack and other information
1.
WHAT IDISAN 30 MG IS AND WHAT IT IS USED FOR
Idisan 30 mg contains the active substance icatibant.
This medicine 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.
Idisan 30 mg blocks the activity of bradykinin and therefore ends the
further progression of the
symptoms.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE IDISAN 30 MG
DO NOT USE IDISAN 30 MG
-
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 Idisan 30 mg:
-
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 Idisan 30 mg 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
this medicine.
In

Scheda tecnica

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SUMMARY OF PRODUCT CHARACTERISTICS
Page 2 of 13
1
.
NAME OF THE MEDICINAL PRODUCT
Idisan 30 mg solution for injection in a 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 a pre-filled syringe.
The solution is a clear and colourless liquid, pH 5.2 to 5.8,
osmolality 270 to 330 mOsm/Kg.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Idisan 30 mg 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
Idisan 30 mg is intended for use under the guidance of a healthcare
professional.
Posology
_Adults _
The recommended dose for adults is a single subcutaneous injection of
Idisan 30 mg.
In the majority of cases a single injection of Idisan 30 mg is
sufficient to treat an attack. In case of
insufficient relief or recurrence of symptoms, a second injection of
Idisan 30 mg can be administered
after 6 hours. If the second injection produces insufficient relief or
a recurrence of symptoms is
observed, a third injection of Idisan 30 mg can be administered after
a further 6 hours. No more than
3 injections of Idisan 30 mg 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 Idisan 30 mg based on body weight in children
and adolescents (aged 2 to
17 years) is provided in table 1 below.
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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 t