Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - cinqaero

Document Subject

Generated Narrative: MedicinalProductDefinition mp8072777f1d7e921aa6202af1f1964c39

identifier: http://ema.europa.eu/identifier/EU/1/16/1125/001 - 1 vial of 10 mL

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: CINQAERO 10 mg/mL concentrate for solution for infusion

type: Full name

part

part: nan

type: Invented name part

part

part: nan

type: Scientific name part

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type: Strength part

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type: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-8072777f1d7e921aa6202af1f1964c39

identifier: http://ema.europa.eu/identifier/EU/1/16/1125/001 - 1 vial of 10 mL

status: Final

type: Package Leaflet

category: Raw

date: 2022-02-16 13:28:17+0000

author: Organization ACME industry

title: TEST PURPOSES ONLY - cinqaero

Attesters

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

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.

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 precautions 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. Also, talk to your doctor or nurse when you are given CINQAERO:

• if your asthma remains uncontrolled or worsens during treatment with this medicine;

• if you have any of the symptoms of an allergic reaction (e.g. itching, trouble breathing, wheezing, 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 4. Possible side effects ).

Children and adolescents This medicine is NOT intended for use in children and adolescents below the age of 18 years.

Other medicines and CINQAERO Tell your doctor if you are using, have recently used or might use any other medicines.

This is particularly important:

• if you are receiving other medicines which affect your immune system;
• 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.

Driving and using machines It is unlikely that CINQAERO will affect your ability to drive and use machines.

CINQAERO contains sodium This medicine contains 4.6 mg sodium (main component of cooking/table salt) in each vial of 10 mL, and 1.15 mg sodium in each vial of 2.5 mL. This is equivalent to 0.23% and 0.06%, respectively, of the recommended maximum daily dietary intake of sodium for an adult.

Always follow the instructions exactly as your doctor has told you. Check with your doctor if you are not sure.

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 CINQAERO by a doctor or nurse as an infusion (drip) into a vein. The infusion will take about 20 to 50 minutes.

Your doctor or nurse will watch you closely during and after your infusion for signs of an allergic reaction.

If you miss your scheduled dose of CINQAERO If you miss a scheduled 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 cause your asthma symptoms to come back.

If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Serious side effects

• Serious allergic reactions Serious allergic reactions can happen uncommonly (may affect up to 1 in 100 people) while receiving CINQAERO or afterwards. Your doctor or nurse will watch you closely for signs of a reaction. Tell your doctor or nurse straight away if you have any of the symptoms of an allergic reaction (e.g. itching, trouble breathing, wheezing, fever, shivering, dizziness, headache, nausea, vomiting, abdominal discomfort, skin rash, redness or swelling).

Other side effects

Common (may affect up to 1 in 10 people)

• Increase of an enzyme in your blood (blood creatine phosphokinase).

Uncommon (may affect up to 1 in 100 people)

• Muscle pain (myalgia).

Reporting of side effects If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the outer carton and vial label after EXP. The expiry date refers to the last day of that month.

Store in a refrigerator (2 C - 8 C). Do not freeze. Keep the vial in the outer carton in order to protect from light.

Do not throw away any medicines via wastewater. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

What CINQAERO contains

• The active substance is reslizumab. Each mL of concentrate contains 10 mg of reslizumab (10 mg/mL). Each vial of 2.5 mL contains 25 mg of reslizumab and each vial of 10 mL contains 100 mg of reslizumab.
• The other excipients are sodium acetate trihydrate, acetic acid glacial, sucrose and water for injections.

What CINQAERO looks like and contents of the pack CINQAERO is a clear to slightly hazy opalescent, colourless to slightly yellow concentrate for solution for infusion (sterile concentrate). Particles might be present. CINQAERO is supplied in glass vials containing 2.5 mL or 10 mL.

CINQAERO is available in packs containing 1 or 2 vials with 2.5 mL and in packs containing 1 or 2 vials with 10 mL.

Not all pack sizes may be marketed.

Marketing Authorisation Holder Teva B.V. Swensweg 5 2031 GA Haarlem The Netherlands

Manufacturer UAB Teva Baltics Mol t pl. 5 LT-08409 Vilnius Lithuania

Merckle GmbH Graf-Arco-Str. 3 89079 Ulm Germany

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

Belgi /Belgique/Belgien Teva Pharma Belgium N.V./S.A./AG T l/Tel: +32 38207Lietuva UAB Teva Baltics Tel: +370 52660

Te : +359 24899Luxembourg/Luxemburg Teva Pharma Belgium N.V./S.A./AG Belgique/Belgien T l/Tel: +32 38207 esk republika Teva Pharmaceuticals CR, s.r.o. Tel: +420 251007Magyarorsz g Teva Gy gyszergy r Zrt. Tel: +36 12886Danmark Teva Denmark A/S Tlf: +45 44985Malta Teva Pharmaceuticals Ireland L-Irlanda Tel: +44 2075407Deutschland TEVA GmbH Tel: +49 73140Nederland Teva Nederland B.V. Tel: +31 8000228Eesti UAB Teva Baltics Eesti filiaal Tel: +372 6610Norge Teva Norway AS Tlf: +47 66775
Specifar A.B.E.E. : +30 2118805 sterreich ratiopharm Arzneimittel Vertriebs-GmbH Tel: +43 1970Espa a Teva Pharma, S.L.U. Tel: +34 913873Polska Teva Pharmaceuticals Polska Sp. z o.o. Tel: +48 223459France Teva Sant
T l: +33 155917Portugal Teva Pharma - Produtos Farmac uticos, Lda. Tel: +351 214767Hrvatska Pliva Hrvatska d.o.o. Tel: +385 13720Rom nia Teva Pharmaceuticals S.R.L. Tel: +40 212306Ireland Teva Pharmaceuticals Ireland Tel: +44 2075407Slovenija Pliva Ljubljana d.o.o. Tel: +386 15890 sland Teva Pharma Iceland ehf. S mi: +354 5503Slovensk republika TEVA Pharmaceuticals Slovakia s.r.o. Tel: +421 257267Italia Teva Italia S.r.l. Tel: +39 028917Suomi/Finland Teva Finland Oy Puh/Tel: +358 201805
Specifar A.B.E.E.

: +30 2118805Sverige Teva Sweden AB Tel: +46 42121Latvija UAB Teva Baltics fili le Latvij
Tel: +371 67323United Kingdom (Northern Ireland) Teva Pharmaceuticals Ireland Ireland Tel: +44 2075407This leaflet was last revised in .

Detailed information on this medicine is available on the European Medicines Agency web site: