Land: Israel
Sprache: Englisch
Quelle: Ministry of Health
RESLIZUMAB
TEVA ISRAEL LTD
R03DX08
CONCENTRATE FOR SOLUTION FOR INFUSION
RESLIZUMAB 10 MG / 1 ML
I.V
Required
TEVA ISRAEL LTD, ISRAEL
RESLIZUMAB
CINQAIR is indicated for the add-on maintenance treatment of patients with severe asthma aged 18 years and older with an eosinophilic phenotype [see Clinical Studies (14)].Limitation of Use:• CINQAIR is not indicated for treatment of other eosinophilic conditions.• CINQAIR is not indicated for the relief of acute bronchospasm or status asthmaticus
2022-07-31
PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS (PREPARATIONS) – 1986 The medicine is dispensed with a doctor's prescription only CINQAIR ® CONCENTRATE FOR SOLUTION FOR INFUSION COMPOSITION: The active ingredient is reslizumab. Each 10 mL vial contains: Reslizumab 100 mg Each 1 mL contains 10 mg of reslizumab. Dilution by a healthcare professional is required before administration. For information regarding inactive ingredients and allergens, see section 2 - “Important information about some ingredients of the medicine” and section 6 - “Additional information”. READ THE ENTIRE LEAFLET CAREFULLY BEFORE USING THE MEDICINE. This leaflet contains concise information about the medicine. If you have additional questions, refer to the doctor or the pharmacist. This medicine has been prescribed for your treatment. Do not pass it on to others. It may harm them even if it seems to you that their medical condition is similar. A SEVERE ALLERGIC REACTION (ANAPHYLAXIS) Severe allergic reactions (anaphylaxis) may occur immediately after receiving the Cinqair infusion. These reactions may cause death. Sometimes the allergic reactions do not occur immediately. The medical staff will monitor your condition during and following the Cinqair infusion to identify any sign of an allergic reaction. Tell the doctor immediately if you experience symptoms that may be associated with an allergic reaction (see section 4 – “Side effects”). 1. WHAT IS THE MEDICINE INTENDED FOR? In combination with other medicines, Cinqair is indicated as a maintenance therapy for severe eosinophilic asthma in patients who are 18 years and older. Cinqair is not indicated: • As a treatment for other medical conditions caused by eosinophils. • For the relief of acute bronchospasm or status asthmaticus. How does Cinqair work: Medicines like Cinqair decrease the blood eosinophil level. Eosinophils are a type of white blood cells which may worsen asthma. When Cinqair is given in combination with other medicines for treatment of Lesen Sie das vollständige Dokument
Page 1 of 15 Cinqair-conc-for-sol-for-inf-SPC-notif-KK-02-2022 SUMMARY OF PRODUCT CHARACTERISTICS NAME OF THE MEDICINAL PRODUCT: CINQAIR PHARMACEUTICAL FORM: Concentrate for Solution for Infusion. QUALITATIVE AND QUANTITATIVE COMPOSITION Each mL of concentrate contains 10 mg of reslizumab (10 mg/mL). Each vial of 10 mL contains 100 mg of reslizumab. Excipient with known effect: Each vial of 10 mL contains 0.20 mmol (4.6 mg) of sodium. WARNING: ANAPHYLAXIS ANAPHYLAXIS HAS BEEN OBSERVED WITH CINQAIR INFUSION IN 0.3% OF PATIENTS IN PLACEBO-CONTROLLED CLINICAL STUDIES. ANAPHYLAXIS WAS REPORTED AS EARLY AS THE SECOND DOSE OF CINQAIR _[_S_EE _ _WARNINGS _ _AND _ _PRECAUTIONS _ _(5.1), _ _ADVERSE _ _REACTIONS (6)]_. ANAPHYLAXIS CAN BE LIFE-THREATENING. PATIENTS SHOULD BE OBSERVED FOR AN APPROPRIATE PERIOD OF TIME AFTER CINQAIR ADMINISTRATION BY A HEALTHCARE PROFESSIONAL PREPARED TO MANAGE ANAPHYLAXIS. DISCONTINUE CINQAIR IMMEDIATELY IF THE PATIENT EXPERIENCES SIGNS OR SYMPTOMS OF ANAPHYLAXIS _[SEE _ _DOSAGE AND ADMINISTRATION (2.2), WARNINGS AND PRECAUTIONS (5.1)]_. 1. INDICATIONS AND USAGE CINQAIR is indicated for the add-on maintenance treatment of patients with severe asthma aged 18 years and older with an eosinophilic phenotype _[see Clinical Studies (14)]._ Limitation of use: CINQAIR is not indicated for treatment of other eosinophilic conditions. CINQAIR is not indicated for the relief of acute bronchospasm or status asthmaticus _[see Warnings and Precautions (5.2)]._ 2. DOSAGE AND ADMINISTRATION 2.1 DOSING CINQAIR is for intravenous infusion only. Do not administer as an intravenous push or bolus. The recommended dosage regimen is 3 mg/kg once every 4 weeks administered by intravenous infusion over 20 - 50 minutes_ [see Dosage and Administration (2.2)]._ Page 2 of 15 Cinqair-conc-for-sol-for-inf-SPC-notif-KK-02-2022 Discontinue the infusion immediately if the patient experiences a severe systemic reaction, including anaphylaxis_ [see Contraindications (4), Warnings and Precautions (5.1)]._ _ _ 2.2 PREPARA Lesen Sie das vollständige Dokument