CINQAIR

Pays: Israël

Langue: anglais

Source: Ministry of Health

Ingrédients actifs:

RESLIZUMAB

Disponible depuis:

TEVA ISRAEL LTD

Code ATC:

R03DX08

forme pharmaceutique:

CONCENTRATE FOR SOLUTION FOR INFUSION

Composition:

RESLIZUMAB 10 MG / 1 ML

Mode d'administration:

I.V

Type d'ordonnance:

Required

Fabriqué par:

TEVA ISRAEL LTD, ISRAEL

Domaine thérapeutique:

RESLIZUMAB

indications thérapeutiques:

CINQAIR is indicated for the add-on maintenance treatment of patients with severe asthma aged 18 years and older with an eosinophilic phenotype [see Clinical Studies (14)].Limitation of Use:• CINQAIR is not indicated for treatment of other eosinophilic conditions.• CINQAIR is not indicated for the relief of acute bronchospasm or status asthmaticus

Date de l'autorisation:

2022-07-31

Notice patient

PATIENT LEAFLET IN ACCORDANCE WITH THE
PHARMACISTS’ REGULATIONS (PREPARATIONS) – 1986
The medicine is dispensed with a doctor's prescription only
CINQAIR
®
CONCENTRATE FOR SOLUTION FOR INFUSION
COMPOSITION:
The active ingredient is reslizumab.
Each 10 mL vial contains:
Reslizumab 100 mg
Each 1 mL contains 10 mg of reslizumab.
Dilution
by
a
healthcare
professional
is
required
before
administration.
For information regarding inactive ingredients and allergens,
see section 2 - “Important information about some ingredients
of the medicine” and section 6 - “Additional information”.
READ THE ENTIRE LEAFLET CAREFULLY BEFORE USING THE MEDICINE.
This leaflet contains concise information about the medicine.
If you have additional questions, refer to the doctor or the
pharmacist.
This medicine has been prescribed for your treatment. Do not
pass it on to others. It may harm them even if it seems to you
that their medical condition is similar.
A SEVERE ALLERGIC REACTION (ANAPHYLAXIS)
Severe
allergic
reactions
(anaphylaxis)
may
occur
immediately after receiving the Cinqair infusion. These
reactions
may
cause
death.
Sometimes
the
allergic
reactions do not occur immediately. The medical staff will
monitor your condition during and following the Cinqair
infusion to identify any sign of an allergic reaction.
Tell the doctor immediately if you experience symptoms
that may be associated with an allergic reaction (see
section 4 – “Side effects”).
1. WHAT IS THE MEDICINE INTENDED FOR?
In combination with other medicines, Cinqair is indicated as
a maintenance therapy for severe eosinophilic asthma in
patients who are 18 years and older.
Cinqair is not indicated:
•
As a treatment for other medical conditions caused by
eosinophils.
•
For the relief of acute bronchospasm or status asthmaticus.
How does Cinqair work:
Medicines like Cinqair decrease the blood eosinophil level.
Eosinophils are a type of white blood cells which may worsen
asthma.
When Cinqair is given in combination with other medicines for
treatment of

Résumé des caractéristiques du produit

Page 1 of 15
Cinqair-conc-for-sol-for-inf-SPC-notif-KK-02-2022
SUMMARY OF PRODUCT CHARACTERISTICS
NAME OF THE MEDICINAL PRODUCT:
CINQAIR
PHARMACEUTICAL FORM:
Concentrate for Solution for Infusion.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each mL of concentrate contains 10 mg of reslizumab (10 mg/mL).
Each vial of 10 mL contains 100 mg of reslizumab.
Excipient with known effect:
Each vial of 10 mL contains 0.20 mmol (4.6 mg) of sodium.
WARNING: ANAPHYLAXIS
ANAPHYLAXIS HAS BEEN OBSERVED WITH CINQAIR INFUSION IN 0.3% OF
PATIENTS IN
PLACEBO-CONTROLLED CLINICAL STUDIES. ANAPHYLAXIS WAS REPORTED AS EARLY
AS THE
SECOND
DOSE
OF
CINQAIR
_[_S_EE _
_WARNINGS _
_AND _
_PRECAUTIONS _
_(5.1), _
_ADVERSE _
_REACTIONS (6)]_.
ANAPHYLAXIS
CAN
BE
LIFE-THREATENING.
PATIENTS
SHOULD
BE
OBSERVED
FOR
AN
APPROPRIATE
PERIOD
OF
TIME
AFTER
CINQAIR
ADMINISTRATION
BY
A
HEALTHCARE
PROFESSIONAL
PREPARED
TO
MANAGE
ANAPHYLAXIS.
DISCONTINUE
CINQAIR
IMMEDIATELY IF THE PATIENT EXPERIENCES SIGNS OR SYMPTOMS OF
ANAPHYLAXIS _[SEE _
_DOSAGE AND ADMINISTRATION (2.2), WARNINGS AND PRECAUTIONS (5.1)]_.
1. INDICATIONS AND USAGE
CINQAIR is indicated for the add-on maintenance treatment of patients
with severe
asthma aged 18 years and older with an eosinophilic phenotype _[see
Clinical Studies (14)]._
Limitation of use:

CINQAIR is not indicated for treatment of other eosinophilic
conditions.

CINQAIR
is
not
indicated
for
the
relief
of
acute
bronchospasm
or
status
asthmaticus _[see Warnings and Precautions (5.2)]._
2. DOSAGE AND ADMINISTRATION
2.1
DOSING
CINQAIR is for intravenous infusion only. Do not administer as an
intravenous push or
bolus.
The recommended dosage regimen is 3 mg/kg once every 4 weeks
administered by
intravenous infusion over 20 - 50 minutes_ [see Dosage and
Administration (2.2)]._
Page 2 of 15
Cinqair-conc-for-sol-for-inf-SPC-notif-KK-02-2022
Discontinue the infusion immediately if the patient experiences a
severe systemic reaction,
including anaphylaxis_ [see Contraindications (4), Warnings and
Precautions (5.1)]._
_ _
2.2
PREPARA