Icatibant Sandoz 30 mg, oplossing voor injectie in een voorgevulde spuit

Land: Nederland

Taal: Nederlands

Bron: CBG-MEB (College ter Beoordeling van Geneesmiddelen)

Werkstoffen:

ICATIBANTACETAAT SAMENSTELLING overeenkomend met ; ; ICATIBANT 10 mg/ml

INN (Algemene Internationale Benaming):

ICATIBANTACETAAT SAMENSTELLING overeenkomend met ; ; ICATIBANT 10 mg/ml

farmaceutische vorm:

Oplossing voor injectie

Samenstelling:

AZIJNZUUR (E 260), GECONCENTREERD ; NATRIUMCHLORIDE ; NATRIUMHYDROXIDE (E 524) ; WATER VOOR INJECTIE

Toedieningsweg:

Subcutaan gebruik

Autorisatie datum:

2022-04-11

Bijsluiter

1
Sandoz B.V.
Page 1/11
Icatibant Sandoz 30 mg, oplossing voor injectie in voorgevulde spuit
RVG 128187
1311-v1
1.3.1.3 Package Leaflet
Februari 2022
PACKAGE LEAFLET: INFORMATION FOR THE USER
ICATIBANT SANDOZ 30 MG, OPLOSSING VOOR INJECTIE IN EEN VOORGEVULDE
SPUIT
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
is and what it is used for
2.
What you need to know before you use
3.
How to use
4.
Possible side effects
5.
How to store
6.
Contents of the pack and other information
1.
WHAT IS AND WHAT IT IS USED FOR

contains the active substance 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.

blocks the activity of bradykinin and therefore ends the further
progression of the
symptoms.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE
DO NOT USE
-
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 :
-
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
are similar to

Productkenmerken

Sandoz B.V.
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Icatibant Sandoz 30 mg, oplossing voor injectie in voorgevulde spuit
RVG 128187
1311-v1
1.3.1.1 Summary of the Product Characteristics
December 2021
1
1.
NAME OF THE MEDICINAL PRODUCT
Icatibant Sandoz 30 mg, oplossing voor injectie in een voorgevulde
spuit
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.
The solution has a pH of approximately 5.5 and an osmolality of
approximately 300 mOsm/kg.
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