Patient leaflet - CINQAERO 10 MG / ML CONCENTRATE FOR SOLUTION FOR INFUSION
2. What you need to know before you are given CINQAERO
You must not receive CINQAERO:
– if you are allergic to reslizumab or any of the other ingredients of this medicine (listed in section 6).
Warnings and precaution
g machines
CINQAERO will affect your
ability to drive and use machines.
CINQAERO contains sodium
This medicine contains 4.6 mg sodium (main
component of co 10 mL, and 1.15
oking/table salt) in each vial of mg sodium in each vial of 2.5
Code starting position
CINQAEROIO mg/mL concentrate for solution for infusion reslizumab
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What is in this leaflet
-
1. What CINQAERO is and what it is
-
2. What you need to know before yo
CINQAERO
-
3. How CINQAERO is given
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4. Possible side effects
-
5. How to store CINQAERO
used for u are given
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 anoth medicine. Eosinophilic asthma is a
er asthma 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 blood and lungs. Eosinophils are w
in your hite 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 CIN
QAERO
CINQAERO reduces how often you have flare-ups of your asthma, helps you breathe
better and decreases your asthma
symptoms.
The following information is intend healthcare professionals only:
ed for
CINQAERO is provided as a concentrate for solution for infusion in a single-use vial. The solution for infusion is intended only for intravenous use after dilution and should be prepared using aseptic technique as follows:
Traceability
In order to improve the traceability
of
biological medicinal products, the name and the batch number of the administered product should be clearly recorded.
Pre parati on of soluti on for i nfusi on—
1. Remove CINQAERO from the refrigerator. Do
not shake the vial.
2. The medicinal product should be
inspected
visually before use. The concentrate is clear to slightly hazy opalescent, colourless to
slightly yellow. Proteinaceous particles may be present in the concentrate that appear as
Talk to your doctor or nurse before you are given CINQAERO:
– if you have a parasitic infection or if you live in an area where parasitic infections are common or if you are travelling to such a region, as this medicine may weaken your body’s ability to fight certain types of parasitic infections.
mL. This is equivalent to 0.23% and 0.06%, respectively, of the recommended maximum daily dietary intake of sodium for an adult.
3. How CINQAERO is given
Always follow the instructions exactly as your
doctor has told y you are not sure.
ou. Check with your doctor if
Also, talk to your doctor o given CINQAERO:
– if your asthma remains
r nurse when you are
uncontrolled or
worsens during treatment with this
medicine;
– if you have any of the allergic reaction (e.g. breathing, wheezing,
symptoms of an itching, trouble fever, shivering,
dizziness, headache, nausea, vomiting, abdominal discomfort, skin rash, redness or swelling). Serious allergic reactions have occurred in patients receiving this
medicine (see section effects”).
“4. Possible side
Children and adolescents
This medicine is NOT intended for use in
children and adolescents years.
below the age of 18
Other medicines and CINQAERO
Tell your doctor if you are used or might use any oth
using, have recently er medicines.
This is particularly import – if you are receiving othe affect your immune syst
ant:
r medicines which tem;
– if you have recently received a vaccination or
if you are likely to need
a vaccination.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before you are given this medicine.
The active substance in this medicine may pass into breast milk but only during the first few days after birth.
translucent to white, amorphous particles, some of which may look fibrous. This is not unusual for proteinaceous solutions. The concentrate must not be used if coloured (except slightly yellow) or if foreign particles are present.
3. A suitable injection syringe should be used
to withdraw the needed
amount of
concentrate from the vial(s) (see section
4.2 of Summary of Prod
uct Characteristics).
4. Slowly dispense the contents of the syringe(s) into an infusion bag containing 50 mL of sodium chloride 9 mg/mL (0.9%) solution for infusion. Gently invert the bag to mix the solution. This medicinal product
must not be mixed with
other medicinal
products except sodium chloride 9 mg/mL (0.9%) solution for infusion.
5. Any concentrate remaining in the vial must
be discarded.
6. It is recommended that infusion be administere
the solution for d immediately after
preparation. Solutions of CINQAERO diluted
The dose depends on your body weight. Your
doctor will work
out the right dose for you. The
maximum dose is 3 mg per kg of body weight. CINQAERO will be given every 4 weeks. You
will be given CIN as an infusion (d will take about 2
QAERO by a doctor or nurse rip) into a vein. The infusion 0 to 50 minutes.
Your doctor or nurse will watch you closely
during and after allergic reaction
your infusion for signs of an
If you miss your
If you miss a sch
scheduled dose of CINQAERO eduled dose of CINQAERO,
ask your doctor when to schedule your next treatment.
If you stop using
CINQAERO
Do NOT stop treatment with CINQAERO unless
your doctor tells
you to, even if you feel better.
Interrupting or stopping treatment with this
medicine may ca come back.
use your asthma symptoms to
If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.
4. Possible side effects
Like all medicines, this medicine can cause
side effects, alth them.
ough not everybody gets
in sodium chlo
ride 9 mg/mL (0.9%) solution
for infusion may be stored refrigerated at 2 °C-8 °C (or not above 25 °C if dilution has
taken place in
controlled and validated
aseptic conditions), protected from light for up to 16 hours.
7. CINQAERO is compatible with
polyvinylchlori infusion bags.
de (PVC) or polyolefin (PO)
te^a
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| Serious side effects
| appen in AERO or will watch n. Tell your you have any eaction (e.g. zing, fever, | |||||
6. Contents of the pack and other information
What CINQAERO contain
-
– The active substance is Each mL of concentrat reslizumab (10 mg/mL contains 25 mg of resli of 10 mL contains 100
-
– The other excipients ar
s
reslizumab.
e contains 10 mg of ). Each vial of 2.5 mL zumab and each vial mg of reslizumab. e sodium acetate
shivering, dizziness, headache, vomiting, abdominal discomfort, redness or swelling).
Other side effects
Common (may affect up to 1 in 10
- Increase of an enzyme in your bl creatine phosphokinase).
- Uncommon (may affect up to 1 in 1 Muscle pain (myalgia).
nausea, trihydrate, acetic acid g
skin rash, water for injections.
What CINQAERO looks li the pack
CINQAERO is a clear to s people) opalescent, colourless to
ood (blood concentrate for solution f
concentrate). Particles m CINQAERO is supplied in 00 people) 2.5 mL or 10 mL.
lacial, sucrose and
ke and contents of
lightly hazy slightly yellow or infusion (sterile ight be present.
glass vials containing
Reporting of side effects
If you get any side effects, talk to y pharmacist or nurse. This include possible side effects not listed in t You can also report side effects dir Yellow Card Scheme Website: or s MHRA Yellow Card in the Google P App Store.
CINQAERO is available in 2 vials with 2.5 mL and in our doctor, 2 vials with 10 mL.
any
his leaflet. Not all pack sizes may be
ectly via the
Marketing Authorisation earch for Teva UK Limited,
lay or Apple Ridings Point,
Whistler Drive, Castleford, WF10 5HX
packs containing 1 or packs containing 1 or
marketed.
Holder
By reporting side effects you can h more information on the safety of medicine.
elp provide this
United Kingdom
Manufacturer
Merckle GmbH Graf-Arco-Str. 3 89079 Ulm Germany
This leaflet was last revi
PLGB 00289/2367
sed in 06/2021.
5. How to store CINQAERO ■
Keep this medicine out of the sigh of children.
Do not use this medicine after the which is stated on the outer carton
t and reach
expiry date and vial
label after EXP. The expiry date ref last day of that month.
Store in a refrigerator (2 °C-8 °C). freeze.
Keep the vial in the outer carton in protect from light.
Do not throw away any medicines wastewater. Ask your pharmacist away medicines you no longer use
ers to the
Do not
order to
via
how to throw. These
measures will help protect the env
ironment.
EAS6203a
Instructions for administration
1. CINQAERO should be administe healthcare professional prepare hypersensitivity reactions includ
evaluate the co-admini red by a with other medicinal p
d to manage 5. An infusion set with an ing non-pyrogenic, single-
stration of reslizumab roducts.
in-line, sterile, use,
anaphylaxis (see section 4.4 of S Product Characteristics). The pa be observed over the duration of and for an appropriate period af Patients should be instructed on recognise symptoms of serious reactions.
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2. If the solution for infusion has b a refrigerator, allow it to reach r temperature (15 °C-25 °C).
-
3. The solution for infusion should
ummary of low-protein-binding filt
tient has to 0.2 pm) should be usee
the infusion CINQAERO is compatib
terwards. polyethersulfone (PES)
how to fluoride (PVDF), nylon,
allergic low protein binding in-
6. Upon completion of the een stored in infusion set with steril
oom 9 mg/mL (0.9%) solutio
ensure that all of the C be infused infusion has been adm
er (pore size of for infusion.
le with
, polyvinylidene cellulose acetate (CA) line infusion filters.
infusion, flush the sodium chloride n for infusion to INQAERO solution for inistered.
intravenously over 20 – 50 minut time may vary depending on the to be infused.
4. The solution for infusion should infused concomitantly in the sam intravenous line with other med products. No physical or bioche compatibility studies have been
es. Infusion
total volume For dosing instructions s
Summary of Product Cha
not be
e
icinal
mical
conducted to
ee section 4.2 of racteristics.
EAS6203a
REG0291198
Version 0.2
Approved
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