Kraj: Unia Europejska
Język: angielski
Źródło: EMA (European Medicines Agency)
Zanamivir
GlaxoSmithKline Trading Services Limited
J05AH01
Zanamivir
Antivirals for systemic use
Influenza, Human
Dectova is indicated for the treatment of complicated and potentially life-threatening influenza A or B virus infection in adult and paediatric patients (aged ≥6 months) when:The patient’s influenza virus is known or suspected to be resistant to anti-influenza medicinal products other than zanamivir, and/orOther anti-viral medicinal products for treatment of influenza, including inhaled zanamivir, are not suitable for the individual patient.Dectova should be used in accordance with official guidance.
Revision: 4
Authorised
2019-04-26
23 B. PACKAGE LEAFLET 24 Package leaflet: Information for the patient DECTOVA 10 MG/ML SOLUTION FOR INFUSION zanamivir This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects. 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 or nurse. - If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Dectova is and what it is used for 2. What you need to know before you are given Dectova 3. How Dectova is given 4. Possible side effects 5. How to store Dectova 6. Contents of the pack and other information 1. WHAT DECTOVA IS AND WHAT IT IS USED FOR Dectova contains zanamivir, which belongs to a group of medicines called antivirals. Dectova IS USED TO TREAT SEVERE FLU (influenza A or B virus infection). It is used when other flu treatments are not suitable. Adults and children aged 6 months or more can be treated with Dectova. 2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN DECTOVA DO NOT USE DECTOVA: • IF YOU ARE ALLERGIC to zanamivir or any of the other ingredients of this medicine (listed in section 6). WARNINGS AND PRECAUTIONS Serious skin or allergic reactions Serious skin or allergic reactions may occur after Dectova is given. Symptoms may include skin or throat swelling, difficulty breathing, blistering rash or peeling skin (see also ‘ _Serious skin or allergic reactions_ ’ in section 4). Sudden changes in behaviour, hallucinations and fits During treatment with Dectova, changes in behaviour such as confusion and unresponsiveness may occur. Some people may also have hallucinations (seeing, hearing, or feeling things that are not there) or fits (seizures) wh Przeczytaj cały dokument
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 for how to report adverse reactions. 1. NAME OF THE MEDICINAL PRODUCT Dectova 10 mg/mL solution for infusion 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each mL of solution contains 10 mg of zanamivir (as hydrate). Each vial contains 200 mg of zanamivir (as hydrate) in 20 mL. Excipients with known effect Each vial contains 3.08 mmol (70.8 mg) sodium. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for infusion Clear, colourless. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Dectova is indicated for the treatment of complicated and potentially life-threatening influenza A or B virus infection in adult and paediatric patients (aged ≥6 months) when: • The patient’s influenza virus is known or suspected to be resistant to anti-influenza medicinal products other than zanamivir, and/or • Other anti-viral medicinal products for treatment of influenza, including inhaled zanamivir, are not suitable for the individual patient. Dectova should be used in accordance with official guidance. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _ _ Treatment with Dectova should commence as soon as possible and usually within 6 days of the onset of symptoms of influenza (see section 5.1). _Adults _ The recommended dose is 600 mg twice daily for 5 to 10 days given by intravenous infusion. _Paediatric population _ 3 Adolescents, children and infants should receive a weight-based dose regimen for 5 to 10 days (Table 1). TABLE 1: WEIGHT-BASED DOSE REGIMEN BY AGE FOR INFANTS, CHILDREN AND ADOLESCENTS WITH NORMAL RENAL FUNCTION AGE RANGE WEIGHT-BASED DOSE REGIMEN 6 months to < 6 years 14 mg/kg twice daily ≥ 6 years to < 18 years 12 mg/kg twice daily up to a maximum dose of 600 mg twice daily _Elderly _ No dose adjustment is requ Przeczytaj cały dokument