Država: Europska Unija
Jezik: engleski
Izvor: EMA (European Medicines Agency)
Reslizumab
Teva B.V.
R03DX08
reslizumab
Other systemic drugs for obstructive airway diseases,
Asthma
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.
Revision: 11
Authorised
2016-08-15
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 Pročitajte cijeli dokument
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 Pročitajte cijeli dokument