Ruconest

Maa: Euroopan unioni

Kieli: englanti

Lähde: EMA (European Medicines Agency)

Aktiivinen ainesosa:

Recombinant human C1-inhibitor

Saatavilla:

Pharming Group N.V.

ATC-koodi:

B06AC04

INN (Kansainvälinen yleisnimi):

conestat alfa

Terapeuttinen ryhmä:

Drugs used in hereditary angioedema, Other hematological agents

Terapeuttinen alue:

Angioedemas, Hereditary

Käyttöaiheet:

Ruconest is indicated for treatment of acute angioedema attacks in adults with hereditary angioedema (HAE) due to C1-esterase-inhibitor deficiency.

Tuoteyhteenveto:

Revision: 12

Valtuutuksen tilan:

Authorised

Valtuutus päivämäärä:

2010-10-28

Pakkausseloste

35
B. PACKAGE LEAFLET
36
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
RUCONEST 2100 UNITS POWDER FOR SOLUTION FOR INJECTION
conestat alfa
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.
-
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. This includes any
possible side effects not listed in this
leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Ruconest is and what it is used for
2.
What you need to know before you use Ruconest
3.
How to use Ruconest
4.
Possible side effects
5.
How to store Ruconest
6.
Contents of the pack and other information
1.
WHAT RUCONEST IS AND WHAT IT IS USED FOR
Ruconest contains conestat alfa as the active substance. Conestat alfa
is a recombinant (not blood-derived)
form of human C1 inhibitor (rhC1-INH).
Ruconest is to be used by adults, adolescents, and children (aged 2
years and above) with a rare inherited
blood disorder, called Hereditary Angioedema
(HAE). These patients have a shortage of the C1 inhibitor
protein in their blood. This can lead to repeated attacks of swelling,
pain in the abdomen, difficulty breathing
and other symptoms.
The administration of Ruconest is to resolve the shortage of C1
inhibitor and will lead to reduction of
symptoms of an acute attack of HAE.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE RUCONEST
DO NOT USE RUCONEST
•
If you are or think you are allergic to rabbits.
•
If you are allergic to conestat alfa or any of the other ingredients
of this medicine (listed in section 6).
WARNINGS AND PRECAUTIONS
Talk to your doctor before using Ruconest.
If you experience allergic reactions e.g. hives, rash, itching,
dizziness, wheezing, difficulty breathing or your
tongue swells up following the administration of Ruconest, you shoul

Valmisteyhteenveto

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Ruconest 2100 Units powder for solution for injection.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One vial contains 2100 units of conestat alfa, corresponding to 2100
units per 14 ml after reconstitution, or a
concentration of 150 units/ml.
Conestat alfa is a recombinant analogue of the human C1 esterase
inhibitor (rhC1-INH) produced by
recombinant DNA technology in the milk of transgenic rabbits.
1 unit of conestat alfa activity is defined as the equivalent of C1
esterase inhibiting activity present in 1 ml of
pooled normal plasma.
Excipient with known effect:
Each vial contains approximately 19.5 mg sodium.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder for solution for injection.
White to off-white powder.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Ruconest is indicated for treatment of acute angioedema attacks in
adults, adolescents, and children (aged
2 years and above) with hereditary angioedema (HAE) due to C1 esterase
inhibitor deficiency.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Ruconest should be initiated under the guidance and supervision of a
physician experienced in the diagnosis
and treatment of hereditary angioedema.
Posology in adults, adolescents and children aged 2 years and above
_Body weight up to 84 kg _
-
One intravenous injection of 50 U/kg body weight.
_Body weight of 84 kg or greater _
-
One intravenous injection of 4200 U (2 vials).
In the majority of cases, a single dose of Ruconest is sufficient to
treat an acute angioedema attack.
In case of an insufficient clinical response, an additional dose (50
U/kg body weight up to 4200 U) can be
administered at the discretion of the physician (see section 5.1).
-
In adults and adolescents an additional dose may be administered if
the patient has not responded
adequately after 120 minutes.
-
In children an additional dose may be administered if the patient has
not responded adequately after 60
minutes.
Not more than two do