Cinryze

Maa: Euroopan unioni

Kieli: englanti

Lähde: EMA (European Medicines Agency)

Aktiivinen ainesosa:

C1 inhibitor (human)

Saatavilla:

Takeda Manufacturing Austria AG

ATC-koodi:

B06AC01

INN (Kansainvälinen yleisnimi):

C1 inhibitor (human)

Terapeuttinen ryhmä:

c1-inhibitor, plasma derived, Drugs used in hereditary angioedema

Terapeuttinen alue:

Angioedemas, Hereditary

Käyttöaiheet:

Treatment and pre-procedure prevention of angioedema attacks in adults, adolescents and children (2 years old and above) with hereditary angioedema (HAE).Routine prevention of angioedema attacks in adults, adolescents and children (6 years old and above) with severe and recurrent attacks of hereditary angioedema (HAE), who are intolerant to or insufficiently protected by oral prevention treatments, or patients who are inadequately managed with repeated acute treatment.

Tuoteyhteenveto:

Revision: 23

Valtuutuksen tilan:

Authorised

Valtuutus päivämäärä:

2011-06-15

Pakkausseloste

26
B. PACKAGE LEAFLET
27
PACKAGE LEAFLET: INFORMATION FOR THE USER
CINRYZE 500 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
Human C1-esterase inhibitor
This medicine is subject to additional monitoring. This will allow
quick identification of new
safety information. You can help by reporting any side effects you may
get. See the end of section 4
for how to report side effects.
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING 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 leaftlet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Cinryze is and what it is used for
2.
What you need to know before you take Cinryze
3.
How to take Cinryze
4.
Possible side effects
5.
How to store Cinryze
6.
Contents of the pack and other information
1.
WHAT CINRYZE IS AND WHAT IT IS USED FOR
Cinryze contains the human protein called “C1-esterase inhibitor”
as the active substance.
C1-esterase inhibitor is a naturally occurring protein that is
normally present in the blood. If you have
a low amount of C1-esterase inhibitor in your blood or your
C1-esterase inhibitor is not working
properly, this can lead to swelling attacks (called angioedema).
Symptoms may include stomach pains
and swelling of the:

hands and feet

face, eyelids, lips or tongue

voice-box (larynx), which may make breathing difficult

genitals
In adults and children, Cinryze can raise the amount of C1-esterase
inhibitor in the blood and either
prevent (prior to undergoing medical or dental procedures) these
swelling attacks from occurring or
stop swelling attacks once they have begun.
In adults, adolescents and children (aged 6 y

Valmisteyhteenveto

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
This medicinal product is subject to additional monitoring. This will
allow quick identification of
new safety information. Healthcare professionals are asked to report
any suspected adverse reactions.
See section 4.8 for how to report adverse reactions.
1.
NAME OF THE MEDICINAL PRODUCT
Cinryze 500 IU powder and solvent for solution for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each single-use powder vial contains 500 International Units (IU) of
Human C1-esterase inhibitor
produced from the plasma of human donors.
After reconstitution, one vial contains 500 IU of Human C1-esterase
inhibitor per 5 ml corresponding
to a concentration of 100 IU/ml. One IU is equivalent to the amount of
C1- esterase inhibitor present
in 1 ml of normal human plasma.
The total protein content of the reconstituted solution is 15 ± 5
mg/ml.
U
Excipient with known effect
Each vial of Cinryze contains approximately 11.5 mg of sodium
.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder and solvent for solution for injection.
White powder.
The solvent is a clear, colourless solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment and pre-procedure prevention of angioedema attacks in
adults, adolescents and children
(2 years old and above) with hereditary angioedema (HAE).
Routine prevention of angioedema attacks in adults, adolescents and
children (6 years old and above)
with severe and recurrent attacks of hereditary angioedema (HAE), who
are intolerant to or
insufficiently protected by oral prevention treatments, or patients
who are inadequately managed with
repeated acute treatment.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Cinryze therapy should be initiated under supervision of a physician
experienced in the care of
patients with hereditary angioedema (HAE).
3
U
Posology
_Adults_
U
_Treatment of angioedema attacks_

1000 IU of Cinryze at the first sign of the onset of an angioedema
attack.

A second dose of 1000 IU may be admini