Cinqaero 10 mg/ml concentrado para solucion para perfusion

Prospecto: information for the patient

CINQAERO 10mg/ml concentrate for solution for infusion

reslizumab

Read the entire prospect carefully before starting to receive this medication, because it contains important information for you.

• Conserve this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor, pharmacist, or nurse.

-If you experience adverse effects, consult your doctor, pharmacist, or nurse, even if they do not appear in this prospect. See section4.

1.What is CINQAERO and for what it is used

2.What you need to know before starting to receive CINQAERO

3.How CINQAERO is administered

4.Possible adverse effects

5.Storage of CINQAERO

6.Contents of the package and additional information

What is CINQAERO

CINQAERO contains the active ingredient reslizumab,a monoclonal antibody, a type of protein that recognizes and binds to a specific target substance in the body.

What is CINQAERO used for

CINQAERO is used to treat severe eosinophilic asthma in adult patients (18years of age or older)when the disease is not well controlled despite treatment with high-dose inhaled corticosteroids together with another asthma medication. Eosinophilic asthma is a type of asthma in which patients have too many eosinophils in the blood or lungs. CINQAERO is used together with other medicationsto treat asthma (inhaled corticosteroids plus other asthma medications).

How CINQAERO works

CINQAERO blocks the activity of interleukin‑5 and reduces the number of eosinophils present in the blood and lungs. Eosinophils are white blood cells (leukocytes) that are involved in asthma inflammation.Interleukin‑5 is a protein produced by the body that plays an essential role in asthma inflammation produced by eosinophil activation.

Benefits of using CINQAERO

CINQAERO reduces the frequency with which you may experience asthma exacerbations, helps you breathe better, and reduces asthma symptoms.

Do not receive CINQAERO:

-if you are allergic to reslizumab or any of the other components of this medication (listed in section6).

Warnings and precautions

Consult your doctor or nurse before starting to receive CINQAERO:

-if you have a parasitic infection or if you live in an area where parasitic infections are common or if you are traveling to such a region, as this medication may weaken your body's ability to fight certain types of parasitic infections.

Also, consult your doctor or nurse while receiving CINQAERO:

-if asthma remains uncontrolled or worsens during treatment with this medication;

-if you experience any symptoms of an allergic reaction (for example, itching, difficulty breathing, wheezing [a high-pitched sound that occurs when breathing], fever, chills, dizziness, headache, nausea, vomiting, abdominal discomfort, skin rash, redness or swelling). Severe allergic reactions have occurred in patients treated with this medication(see section“4.Adverse reactions”).

Children and adolescents

This medication is NOT indicated for use in children and adolescents under 18years.

Other medications and CINQAERO

Inform your doctor if you are using, have used recently or may need to use any other medication.

This is especially important:

• if you are receiving other medications that affect the immune system;
• if you have recently received a vaccine or if you are likely to need a vaccine.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or if you think you may be pregnant or plan to become pregnant, consult your doctor before receiving this medication.

The active ingredient in this medication may pass into breast milk, but only during the first few days after delivery.

Driving and operating machinery

It is unlikely that CINQAERO will affect your ability to drive and operate machinery.

CINQAERO contains sodium

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

Follow exactly the instructions given by your doctor. If in doubt, consult your doctor again.

The dose depends on your body weight. Your doctor will calculate the correct dose for you. The maximum dose is 3mg per kilogram of body weight. CINQAERO will be administered to you every 4weeks. A doctor or nurse will administer CINQAERO to you in the form of an infusion (drip) through a vein. The infusion will last for 20 to 50minutes.

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

If a scheduled dose of CINQAERO is missed

If a scheduled dose of CINQAERO is missed, ask your doctor when to schedule your next treatment.

If treatment with CINQAERO is interrupted

DO NOT interrupt treatment with CINQAERO unless your doctor tells you to, even if you are feeling better. Interrupting or stopping treatment with this medication may cause the symptoms of asthma to return.

If you have any other questions about the use of this medication, ask your doctor, pharmacist, or nurse.

Like all medications, this medication may produce adverse effects, although not all people will experience them.

Severe Adverse Effects

• Severe Allergic Reactions

Severe allergic reactions may occur infrequently (affecting up to 1 in 100 people) during or after administration of CINQAERO. Your doctor or nurse will closely monitor you for signs of a reaction. Consult your doctor or nurse immediately if you experience any of the following symptoms of an allergic reaction (such as itching, breathing difficulties, wheezing [a high-pitched sound when breathing], fever, chills, dizziness, headache, nausea, vomiting, abdominal discomfort, skin rash, redness, or swelling).

Other Adverse Effects

Frequent (may affect up to 1 in 10 people)

• A rise in a blood enzyme (creatine phosphokinase).

Infrequent (may affect up to 1 in 100 people)

• Muscle pain (myalgia).

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through the national notification system included in theAppendix V. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

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

Do not use this medication after the expiration date that appears on the outer box and on the vial label after CAD. The expiration date is the last day of the month indicated.

Store in refrigerator (between 2°C and 8°C). Do not freeze.

Store the vial in the outer packaging to protect it from light.

Medicines should not be disposed of through drains. Ask your pharmacist how to dispose of the packaging and the medication that you no longer need. This will help protect the environment.

Composition of CINQAERO

• The active substance is reslizumab.

Each milliliter of concentrate contains 10mg of reslizumab (10mg/ml).Each vial of 2.5ml contains 25mg of reslizumab and each vial of 10ml contains 100mg of reslizumab.

• The other excipients are sodium acetate trihydrate, glacial acetic acid, sucrose, and water for injection.

Appearance of the product and contents of the pack

CINQAERO is a concentrate for solution for infusion (sterile concentrate) that is transparent and slightly opalescent, and may be colorless or slightly yellowish. It may contain proteinaceous particles that appear as amorphous, translucent, or white particles, some of which may have a fibrous appearance. This is not uncommon for proteinaceous solutions. CINQAERO is supplied in glass vials containing 2.5 ml or 10 ml.

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

Only some pack sizes may be marketed.

Marketing authorization holder

Teva B.V.

Swensweg 5

2031 GA Haarlem

Netherlands

Responsible for manufacturing

UAB Teva Baltics

Moletu pl. 5

LT‑08409 Vilnius

Lithuania

Merckle GmbH

Graf-Arco-Str.3

89079 Ulm

Germany

Further information on this medicinal product can be obtained by contacting the local representative of the marketing authorization holder:

Last update of this leaflet:

The detailed information on this medicinal product is available on the website of the European Medicines Agency:http://www.ema.europa.eu.

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This information is intended for healthcare professionals only:

CINQAERO is supplied as a concentrate for solution for infusion in a single-use vial. The infusion solution is intended for use only by intravenous administration after dilution and should be prepared using aseptic technique as described below:

Traceability

In order to improve the traceability of biologic medicinal products, the name and batch number of the medicinal product administered should be clearly recorded.

Preparation of the infusion solution

1.Remove CINQAERO from the refrigerator. Do not agitate the vial.

2.Visually inspect the medicinal product before use. The concentrate is transparent and slightly opalescent, and may be colorless or slightly yellowish. The concentrate may contain proteinaceous particles that appear as amorphous, translucent, or white particles, some of which may have a fibrous appearance. This is not uncommon for proteinaceous solutions. The concentrate should not be used if it has a color (except for a slight yellowish tint) or if it contains any unusual particles.

3.Use a suitable injection syringe to extract the required amount of concentrate (see section4.2 of the SmPC or Product Characteristics).

4.Slowly transfer the contents of the syringe(s) to an infusion bag containing 50ml of 9mg/ml (0.9%) sodium chloride solution. Gently invert the bag to mix the solution. This medicinal product should not be mixed with any other solution except 9mg/ml (0.9%) sodium chloride solution.

5.Discard any residual concentrate remaining in the vial.

6.It is recommended to administer the infusion solution immediately after preparation. Solutions of CINQAERO diluted in 9mg/ml (0.9%) sodium chloride solution may be stored refrigerated between 2°C and 8°C (or not above 25°C if the dilution has taken place in controlled and validated aseptic conditions), protected from light, for a maximum of 16hours.

7.CINQAERO is compatible with PVC or polyolefin infusion bags.

Administration instructions

1.CINQAERO should be administered by a healthcare professional prepared to treat hypersensitivity reactions including anaphylaxis (see section4.4 of the SmPC or Product Characteristics). The patient should be observed throughout the infusion and for an appropriate period thereafter. Patients should be instructed on how to recognize the symptoms of severe allergic reactions.

2.If the infusion solution has been stored in a refrigerator, allow it to reach room temperature (between 15°C and 25°C).

3.The infusion solution should be infused intravenously over 20‑50minutes. The infusion time may vary depending on the total volume to be administered.

4.The infusion solution should not be infused concomitantly in the same intravenous line with other medicinal products. No studies of physical or biochemical compatibility have been conducted to evaluate the concomitant administration of reslizumab with other medicinal products.

5.For infusion, a single-use, sterile, non-pyrogenic, and low-protein-binding infusion set with a pore size of 0.2µm should be used. CINQAERO is compatible with in-line infusion filters with low protein binding of polyethersulfone (PES), fluorinated polyvinylidene (PVDF), nylon, and cellulose acetate.

6.After the infusion is complete, the infusion set should be purged with a sterile 9mg/ml (0.9%) sodium chloride solution to ensure that all of the CINQAERO infusion solution has been administered.

See section4.2 of the SmPC or Product Characteristics for instructions related to the dosage.