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CINQAERO Concentrate for solution for infusion (2019)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

CINQAERO 10 mg/mL concentrate for solution for infusion.

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 ...

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.

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 ...

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 ...

Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

Special warnings and precautions for use

Reslizumab should not be used to treat acute asthma exacerbations. Asthma-related symptoms or exacerbations may occur during treatment. Patients should be instructed to seek medical advice if their asthma ...

Interaction with other medicinal products and other forms of interaction

No formal clinical drug interaction studies have been performed with reslizumab. In vitro data indicate that IL-5 and reslizumab are unlikely to affect CYP1A2, 3A4 or 2B6 activity. Based on the characteristics ...

Fertility, pregnancy and lactation

Pregnancy There are no or limited amount of data (less than 300 pregnancy outcomes) from the use of reslizumab in pregnant women. Animal studies do not indicate direct or indirect harmful effects with ...

Effects on ability to drive and use machines

CINQAERO has no or negligible influence on the ability to drive and use machines.

Undesirable effects

Summary of the safety profile The most frequently reported adverse reaction during treatment was increased blood creatine phosphokinase, which occurred in approximately 2% of patients. Anaphylactic reaction ...

Overdose

The highest single dose administered intravenously was reported at 12.1 mg/kg and had no clinical consequences for the patient. In case of overdose, it is recommended that the patient be monitored for ...

Pharmacodynamic properties

Pharmacotherapeutic group: Drugs for obstructive airway diseases, other systemic drugs for obstructive airway diseases ATC code: R03DX08 Mechanism of action Reslizumab is a humanised monoclonal antibody ...

Pharmacokinetic properties

Peak serum concentrations of approximately 80 µg/mL are typically observed at the end of the infusion. Serum reslizumab concentrations generally decline from peak in a biphasic manner. Following multiple ...

Preclinical safety data

Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential and toxicity to reproduction and ...

List of excipients

Sodium acetate trihydrate Acetic acid glacial Sucrose Water for injections

Incompatibilities

This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.

Shelf life

3 years. Diluted medicinal product: Chemical and physical in-use stability has been demonstrated at 2°C-8°C and at 25°C in sodium chloride 9 mg/mL (0.9%) solution for infusion protected from light for ...

Special precautions for storage

Store in a refrigerator (2°C-8°C). Do not freeze. Keep the vial in the outer carton in order to protect from light. For storage conditions after dilution of the medicinal product, see section 6.3

Nature and contents of container

2.5 mL of concentrate in a clear type I glass vial closed by a poly(ethylene-co-tetrafluoroethylene)-coated butyl rubber stopper covered with a crimped-on aluminium ring and a white plastic flip-off cap. ...

Special precautions for disposal and other handling

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 ...

Marketing authorization holder

Teva B.V., Swensweg 5, 2031 GA Haarlem, The Netherlands

Marketing authorization number(s)

EU/1/16/1125/001 1 vial of 10 mL EU/1/16/1125/002 1 vial of 2.5 mL EU/1/16/1125/003 2 vials of 10 mL EU/1/16/1125/004 2 vials of 2.5 mL

Date of first authorization / renewal of the authorization

Date of first authorisation: 16 August 2016

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