Country: Evrópusambandið
Tungumál: enska
Heimild: EMA (European Medicines Agency)
chimeric yellow fever dengue virus serotype 1 (live, attenuated), chimeric yellow fever dengue virus serotype 2 (live, attenuated), chimeric yellow fever dengue virus serotype 3 (live, attenuated), chimeric yellow fever dengue virus serotype 4 (live, attenuated)
Sanofi Pasteur
J07BX
dengue tetravalent vaccine (live, attenuated)
Vaccines
Dengue
Dengvaxia is indicated for the prevention of dengue disease caused by dengue virus serotypes 1, 2, 3 and 4 in individuals 6 to 45 years of age with test-confirmed previous dengue infection (see sections 4.2, 4.4 and 4.8).The use of Dengvaxia should be in accordance with official recommendations.
Revision: 5
Authorised
2018-12-12
44 B. PACKAGE LEAFLET 45 PACKAGE LEAFLET: INFORMATION FOR THE USER DENGVAXIA, POWDER AND SOLVENT FOR SUSPENSION FOR INJECTION IN PRE-FILLED SYRINGE dengue tetravalent vaccine (live, attenuated) READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU OR YOUR CHILD IS VACCINATED 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. • This vaccine has been prescribed for you or your child only. Do not pass it on to others. • If you or your child 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 Dengvaxia is and what it is used for 2. What you need to know before you or your child use Dengvaxia 3. How to use Dengvaxia 4. Possible side effects 5. How to store Dengvaxia 6. Contents of the pack and other information 1. WHAT DENGVAXIA IS AND WHAT IT IS USED FOR Dengvaxia is a vaccine. It is used to help protect you or your child against "dengue disease" caused by dengue virus serotypes 1, 2, 3 and 4. It contains versions of these 4 varieties of the virus that have been weakened so that they cannot cause the disease. Dengvaxia is given to adults, young people and children (from 6 to 45 years of age) with prior dengue virus infection confirmed by a test (also see sections 2 and 3). Dengvaxia should be used according to official recommendations. HOW THE VACCINE WORKS Dengvaxia stimulates the body’s natural defences (immune system), to produce antibodies that will help protect against the viruses that cause dengue disease if the body is exposed to them in the future. WHAT IS DENGUE AND DENGUE DISEASE? Dengue is a viral infection which spreads through the bite of an infected _Aedes_ mosquito. The virus from an infected person can spread to other people through mosquito bites for about 4 to 5 days (maximum 12 days) after the first symptoms appear. Dengue is not transmitted direc Lestu allt skjalið
1 _ _ ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Dengvaxia, powder and solvent for suspension for injection in pre-filled syringe dengue tetravalent vaccine (live, attenuated) 2. QUALITATIVE AND QUANTITATIVE COMPOSITION After reconstitution, one dose (0.5 mL) contains: Chimeric yellow fever dengue virus serotype 1 (live, attenuated)* ........... 4.5 - 6.0 log 10 CCID 50 /dose** Chimeric yellow fever dengue virus serotype 2 (live, attenuated)* ........... 4.5 - 6.0 log 10 CCID 50 /dose** Chimeric yellow fever dengue virus serotype 3 (live, attenuated)* ........... 4.5 - 6.0 log 10 CCID 50 /dose** Chimeric yellow fever dengue virus serotype 4 (live, attenuated)* ........... 4.5 - 6.0 log 10 CCID 50 /dose** *Produced in Vero cells by recombinant DNA technology. This product contains genetically modified organisms (GMOs). **CCID 50 : 50% Cell Culture Infectious Dose. Excipients with known effect One dose (0.5 mL) contains 41 micrograms of phenylalanine and 9.38 milligrams of sorbitol. For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Powder and solvent for suspension for injection White, homogenous, freeze-dried powder with possible retraction at the base (ring-shaped cake possible). The solvent is a clear and colourless solution. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Dengvaxia is indicated for the prevention of dengue disease caused by dengue virus serotypes 1, 2, 3 and 4 in individuals 6 to 45 years of age with test-confirmed previous dengue infection (see sections 4.2, 4.4 and 4.8). The use of Dengvaxia should be in accordance with official recommendations. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _ _ _ _ _Children and adults 6 to 45 years of age _ The vaccination schedule consists of 3 injections of one reconstituted dose (0.5 mL) to be administered at 6-month intervals. _Booster dose _ The added value of and appropriate timing for booster dose(s) have not been established. Current available data are included in section 5.1. 3 _Paedia Lestu allt skjalið