Cinqaero

מדינה: האיחוד האירופי

שפה: אנגלית

מקור: EMA (European Medicines Agency)

מרכיב פעיל:

Reslizumab

זמין מ:

Teva B.V.

קוד ATC:

R03DX08

INN (שם בינלאומי):

reslizumab

קבוצה תרפויטית:

Other systemic drugs for obstructive airway diseases,

איזור תרפויטי:

Asthma

סממני תרפויטית:

Cinqaero is indicated as add-on therapy in adult patients with severe eosinophilic asthma inadequately controlled despite high dose inhaled corticosteroids plus another medicinal product for maintenance treatment.

leaflet_short:

Revision: 11

מצב אישור:

Authorised

תאריך אישור:

2016-08-15

עלון מידע

24
B. PACKAGE LEAFLET
25
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
CINQAERO 10 MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION
reslizumab
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN 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, pharmacist or
nurse.
-
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What CINQAERO is and what it is used for
2.
What you need to know before you are given CINQAERO
3.
How CINQAERO is given
4.
Possible side effects
5.
How to store CINQAERO
6.
Contents of the pack and other information
1.
WHAT CINQAERO IS AND WHAT IT IS USED FOR
WHAT CINQAERO IS
CINQAERO contains the active substance reslizumab, a monoclonal
antibody, a type of protein that
recognises and binds to a specific target substance in the body.
WHAT CINQAERO IS USED FOR
CINQAERO is used to treat severe eosinophilic asthma in adult patients
(18 years of age and over)
when the condition is not well controlled despite treatment with
high-dose inhaled corticosteroids
together with another asthma medicine. Eosinophilic asthma is a type
of asthma where patients have
too many eosinophils in the blood or lungs. CINQAERO is used together
with other medicines to treat
asthma (inhaled corticosteroids plus other asthma medicines).
HOW CINQAERO WORKS
CINQAERO blocks interleukin-5 activity and reduces the number of
eosinophils in your blood and
lungs. Eosinophils are white blood cells involved in asthma
inflammation. Interleukin-5 is a protein
your body makes that plays a key role in inflammation in asthma by
activating eosinophils.
WHAT ARE THE BENEFITS OF USING CINQAERO
CINQAERO reduces how often you have flare-ups of your asthma, helps
you breathe better and
decreases your asthma symptoms.
2.
WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN CINQAERO
_ _
YOU MUST NOT RECEIVE CINQAER

מאפייני מוצר

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
CINQAERO 10 mg/mL concentrate for solution for infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each mL of concentrate contains 10 mg of reslizumab (10 mg/mL).
Each vial of 2.5 mL contains 25 mg of reslizumab.
Each vial of 10 mL contains 100 mg of reslizumab.
Reslizumab is a humanised monoclonal antibody produced in mouse
myeloma cells (NS0) by
recombinant DNA technology.
Excipient with known effect
Each vial of 2.5 mL contains 0.05 mmol (1.15 mg) of sodium.
Each vial of 10 mL contains 0.20 mmol (4.6 mg) of sodium.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Concentrate for solution for infusion (sterile concentrate)
Clear to slightly hazy opalescent, colourless to slightly yellow
solution with pH 5.5. Proteinaceous
particles might be present.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
CINQAERO is indicated as add-on therapy in adult patients with severe
eosinophilic asthma
inadequately controlled despite high-dose inhaled corticosteroids plus
another medicinal product for
maintenance treatment (see section 5.1).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
CINQAERO should be prescribed by physicians experienced in the
diagnosis and treatment of the
above-mentioned indication (see section 4.1).
Posology
CINQAERO is given as intravenous infusion once every four weeks.
_Patients BELOW 35 kg or ABOVE 199 kg _
The recommended dose is 3 mg/kg body weight. The volume (in mL)
required from the vial(s) should
be calculated as follows: 0.3 x patient body weight (in kg).
_Patients BETWEEN 35 kg and 199 kg _
The recommended dose is achieved using the vial-based dosing scheme in
Table 1 below. The
recommended dose is based on patient body weight and should only be
adjusted for significant
changes in body weight.
3
TABLE 1: VIAL-BASED DOSING SCHEME* FOR PATIENTS WITH BODY WEIGHT
BETWEEN 35 KG AND 199 KG
BODY WEIGHT
(KG)
RESLIZUMAB TOTAL DOSE
(MG)
NUMBERS OF EACH VIAL**
VIALS WITH 10 ML
CONCENTRATE
(100 MG
RES