Ország: Európai Unió
Nyelv: angol
Forrás: EMA (European Medicines Agency)
rotavirus serotype G1, serotype G2, serotype G3, serotype G4, serotype P1
Merck Sharp & Dohme B.V.
J07BH02
rotavirus vaccine, live
Vaccines, Viral vaccines
Immunization; Rotavirus Infections
RotaTeq is indicated for the active immunisation of infants from the age of six weeks to 32 weeks for prevention of gastroenteritis due to rotavirus infection.RotaTeq is to be used on the basis of official recommendations.
Revision: 36
Authorised
2006-06-26
22 B. PACKAGE LEAFLET 23 PACKAG E LEAFLET: INFORMATION FOR THE U SER ROTATEQ ORAL SOLUTIO N Rotavirus vaccine (live) READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOUR CHILD IS VACCINATED BECAUSE IT CONTA INS IMPORTANT INFORMATION FOR Y OU. - Keep this leafl et. Yo u may need to read it again. - If you have any further questions, ask your doctor or pharmacist. - If your child gets any side effects, talk to your d octor or pharmacist. This includes any possible side e ffects not listed in this leafl et. See section 4. WHAT IS I N THIS LEAFLET 1. What RotaTeq is and what it is used for 2. What you need to know before your child receive s RotaTeq 3. How to use RotaTeq 4. Possible side effects 5. How to store RotaTeq 6. C ontents of the pack and other information 1. WHAT ROTAT EQ IS AND WHAT IT IS USED FOR RotaTeq is an oral vaccine that helps protect infants an d young chil dren against g astroenteritis (diarrhoea and vom iting) caused by rotavirus infection and may be given to infants from the age of 6 weeks to 32 weeks (see section 3). The vaccine contains five types of live rotavirus strains. When an infant is given the va ccine, the immun e system (the body ’s natural d efe nces) will make antibodies against the most commonl y occurring types of rotavirus. Th ese antibodies h elp protect against gastroenteritis caused by these types of rotavirus. 2. WHAT YOU NEED TO KNOW BEFORE YOUR CHILD RECEIVES ROTATEQ DO NO T USE ROTATE Q IF - your child is allergic to any of the components of this vaccine (see section 6 Con tents of the pack and oth er information ). - your child developed an allergic reaction after receiving a dose of RotaTeq or other rotavirus vaccine. - your chil d has previou sly had intussusception (a bowel obstruction in whic h one segment of bowel becomes enfol ded within anot her segmen t). - your child was born with a malformation of the gastrointestinal system that migh t predispose for intussuscept ion. - your child h as any diseas e w hich reduces his/her resistance to infection. - you r child has Olvassa el a teljes dokumentumot
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT RotaTeq ORAL solution Rotavirus vaccine (live) 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One dose (2 ml) contains: rotavirus type* G1 not less than 2.2 x 10 6 IU 1, 2 rotavirus type* G2 not less than 2.8 x 10 6 IU 1, 2 rotavirus type* G3 not less than 2.2 x 10 6 IU 1, 2 rotavirus type* G4 not less than 2.0 x 10 6 IU 1, 2 rotavirus type* P1A[8] not less than 2.3 x 10 6 IU 1, 2 * human- bovine rotavirus reass or tants (live), produced in Vero cells. 1 Infectious Units 2 As lower confidence limit (p = 0.95) Excipients with known effect This vaccine contain s 1080 milligrams sucrose and 37.6 milligrams sodium (see section 4.4). For the full list of excipien ts, see section 6.1. 3. PHARMACEUTICAL F ORM Oral Solution Pale yellow clear liquid that may have a pink tint 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS RotaTeq is indicated for the active immunisation of infants from the age of 6 weeks to 32 weeks for prevention of gastroenteritis due to rotavirus infection (see sections 4.2, 4.4 and 5.1). RotaTeq is to be used on the basis of official recommendations. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology FROM BIRTH TO 6 WEEKS RotaTeq is not ind icated in this subset of paediatri c population. The safety and efficacy of RotaTeq in individuals from birth to 6 weeks of age have not been established. FROM 6 WEEKS TO 32 WEEKS The vaccination course consists of three doses. The first dose m ay be adm inistered from the age of 6 weeks and no later than the age of 12 weeks. 3 RotaTeq may be given to infants who were born prematurely provided that the period of gestation was at least 25 weeks. These infants should receive the first dose of RotaTe q at least six weeks after birth (see sections 4.4 and 5.1). There should be intervals of at least 4 weeks between doses. It is preferable that the vaccination course of three doses should be comp leted by the age of 20-22 weeks. If necessary, the third (last) dose may be given up to the age Olvassa el a teljes dokumentumot