Страна: Европейски съюз
Език: английски
Източник: EMA (European Medicines Agency)
Peramivir
Biocryst
J05AH03
peramivir
Antivirals for systemic use
Influenza, Human
Alpivab is indicated for the treatment of uncomplicated influenza in adults and children from the age of 2 years.
Revision: 2
Withdrawn
2018-04-13
21 B. PACKAGE LEAFLET Medicinal Product no longer authorised 22 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT ALPIVAB 200 MG CONCENTRATE FOR SOLUTION FOR INFUSION peramivir 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 START USING 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 pharmacist. If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Alpivab is and what it is used for 2. What you need to know before you are given Alpivab 3. How Alpivab is given 4. Possible side effects 5. How to store Alpivab 6. Contents of the pack and other information 1. WHAT ALPIVAB IS AND WHAT IT IS USED FOR Alpivab contains the active substance peramivir which belongs to a group of medicines called neuraminidase inhibitors. These medicines prevent the influenza virus from spreading inside the body. Alpivab is used to treat adults and children aged from 2 years with influenza that is not severe enough to require hospitalisation. 2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN ALPIVAB YOU MUST NOT RECEIVE ALPIVAB if you are allergic to peramivir or any of the other ingredients of this medicine (listed in section 6) WARNINGS AND PRECAUTIONS Talk to your doctor or pharmacist before you are given Alpivab if you have reduced kidney function. Your doctor may have to adjust your dose. Tell your doctor immediately if you experience serious skin or allergic reactions after Alpivab is given. Symptoms may include skin or throat swelling, difficulty breathing, blistering rash or peeling skin. See section 4. Tell your doctor immediately if you experience abnormal beha Прочетете целия документ
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS Medicinal Product no longer authorised 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 Alpivab 200 mg concentrate for solution for infusion 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each 20 mL vial of concentrate contains 200 mg peramivir. 1 mL concentrate for solution for infusion contains 10 mg peramivir (anhydrous base). Excipients with known effect Each mL of concentrate contains 0.154 millimole (mmol) sodium, which is 3.54 mg of sodium. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Concentrate for solution for infusion. Clear, colourless, solution. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Alpivab is indicated for the treatment of uncomplicated influenza in adults and children from the age of 2 years (see sections 4.4 and 5.1). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Alpivab should be administered as a single intravenous dose within 48 hours of the onset of symptoms of influenza. The recommended single intravenous dose of peramivir depends on age and body weight as shown in Table 1. TABLE 1: PERAMIVIR DOSE BASED ON AGE AND BODY WEIGHT AGE AND BODY WEIGHT RECOMMENDED SINGLE DOSE Children aged from 2 years and <50 kg 12 mg/kg Children aged from 2 years and ≥50 kg body weight 600 mg Adults and adolescents (13 years and older) 600 mg _Elderly _ No dose adjustment is required based on age (see sections 4.4 and 5.2). Medicinal Product no longer authorised 3 _ _ _Renal impairment _ The dose should be reduced for adults and adolescents (13 years and older) with absolute glomerular filtration rate (GFR) below 50 mL/min as shown in Table 2 (see sections 4.4 and 5.2). TABLE 2: PERAMIVIR DOSE FOR ADULTS AND ADOLESCENTS (FROM 13 YEARS AND 50 KG) BASED ON ABSOLUTE GFR ABSOLUTE GLOMERULAR F Прочетете целия документ