Kraj: Wielka Brytania
Język: angielski
Źródło: MHRA (Medicines & Healthcare Products Regulatory Agency)
Japanese encephalitis virus
Valneva UK Ltd
J07BA02
Japanese encephalitis virus
Suspension for injection
Intramuscular; Subcutaneous
No Controlled Drug Status
Valid as a prescribable product
BNF: 14040000; GTIN: 5060025630953
1 PACKAGE LEAFLET: INFORMATION FOR THE USER IXIARO SUSPENSION FOR INJECTION Japanese encephalitis vaccine (inactivated, adsorbed) READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU OR YOUR CHILD RECEIVE THIS VACCINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. • Keep this leaflet. You and your child may need to read it again. • If you have any further questions, ask your doctor. • This vaccine has been prescribed for you and/or your child only. Do not pass it on to others. • If you and/or your child get any side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What IXIARO is and what it is used for 2. What you need to know before you and/or your child receive IXIARO 3. How IXIARO is given 4. Possible side effects 5. How to store IXIARO 6. Contents of the pack and other information 1. WHAT IXIARO IS AND WHAT IT IS USED FOR IXIARO is a vaccine against the Japanese encephalitis virus. The vaccine causes the body to produce its own protection (antibodies) against this disease. IXIARO is used to prevent infection with the Japanese encephalitis virus (JEV). This virus is mainly found in Asia and is transmitted to humans by mosquitoes that have bitten an infected animal (like pigs). Many infected people develop mild symptoms or no symptoms at all. In people who develop severe disease, JE usually starts as a flu-like illness, with fever, chills, tiredness, headache, nausea, and vomiting. Confusion and agitation also occur in the early stage of disease. IXIARO should be given only to adults, adolescents, children and infants aged 2 months and older travelling to countries, where JE is endemic or who are at risk through work. 2. WHAT YOU NEED TO KNOW BEFORE YOU AND/OR YOUR CHILD RECEIVE IXIARO DO NOT USE IXIARO: • If you and/or your child are allergic (hypersensitive) to the active substance or any of the other ingredients of this medicine (listed in section 6). • If you and/or your child have developed an allergic react Przeczytaj cały dokument
OBJECT 1 IXIARO SUSPENSION FOR INJECTION - JAPANESE ENCEPHALITIS VACCINE (INACTIVATED, ADSORBED) Summary of Product Characteristics Updated 20-Jul-2016 | Valneva UK Limited 1. Name of the medicinal product IXIARO suspension for injection Japanese encephalitis vaccine (inactivated, adsorbed) 2. Qualitative and quantitative composition 1 dose (0.5 ml) of IXIARO contains: Japanese encephalitis virus strain SA 14 -14-2 (inactivated) 1,2 6 AU 3 corresponding to a potency of ≤ 460 ng ED50 1 produced in Vero cells 2 adsorbed on aluminium hydroxide, hydrated (approximately 0.25 milligrams Al 3+ ) 3 Antigen Units Excipients with known effect: This medicine contains potassium, less than 1mmol/dose and sodium, less than 1mmol/dose. Phosphate Buffered Saline 0.0067 M (in PO4) has the following saline composition: NaCl 9mg/mL KH2PO4 0.144 mg/mL Na2HPO4 0.795 mg/mL For the full list of excipients, see section 6.1. 3. Pharmaceutical form Suspension for injection. Clear liquid with a white precipitate. 4. Clinical particulars 4.1 Therapeutic indications IXIARO is indicated for active immunisation against Japanese encephalitis in adults, adolescents, children and infants aged 2 months and older. IXIARO should be considered for use in individuals at risk of exposure through travel or in the course of their occupation. 4.2 Posology and method of administration Posology ADULTS (18-65 YEARS OF AGE) The primary vaccination series consists of two separate doses of 0.5 ml each, according to the following conventional schedule: First dose at Day 0. Second dose: 28 days after first dose. Rapid schedule Persons aged 18-65 years can be vaccinated in a rapid schedule as follows: First dose at Day 0. Second dose: 7 days after first dose. With both schedules, primary immunisation should be completed at least one week prior to potential exposure to Japanese encephalitis virus (JEV) (see section 4.4). It is recommended that vaccinees who received the first dose of IXIARO complete the primary 2-dose vaccination course with IXIARO. If t Przeczytaj cały dokument