RotaTeq · 4.8 Undesirable effects · 1

HOS-154144 · has-adverse-reaction-information · PDF-Seite 6

a. Summary of the safety profile In a subset of infants from 3 placebo-controlled clinical trials (n=6,130 recipients of RotaTeq and 5,560 placebo recipients), RotaTeq was evaluated for all adverse events within 42 days of vaccination with or without concomitant use of other paediatric vaccines. Overall, 47 % of infants given RotaTeq experienced an adverse reaction compared with 45.8 % of infants given placebo. The most commonly reported adverse reactions that occurred more frequently with vaccine than with placebo were pyrexia (20.9 %), diarrhoea (17.6 %) and vomiting (10.1 %). Serious adverse reactions were assessed in all participants (36,150 recipients of RotaTeq and 35,536 placebo recipients) of 3 clinical trials for up to 42 days after each dose. The overall frequency of these serious adverse reactions was 0.1 % among recipients of RotaTeq and 0.2 % among placebo recipients. b. Tabulated summary of adverse reactions Adverse reactions more common in the vaccine group in clinical trials are listed below per system organ class and frequency. Based on pooled data from 3 clinical trials in which 6,130 infants received RotaTeq and 5,560 received placebo, the adverse reactions listed occurred with excess incidences in RotaTeq recipients compared to placebo recipients of between 0.2 % and 2.5 %. Frequencies are reported as: Very common (≥1/10); Common (≥1/100, <1/10); Uncommon (≥1/1,000, <1/100); Rare (≥1/10,000, <1/1,000), Very rare (< 1/10,000), Not known (cannot be estimated from the available data) Adverse reactions following administration of RotaTeq in clinical trials and adverse events reported post-marketing (in italics) System Organ Class Frequency Adverse Reaction/Event Infections and infestations Common Upper respiratory tract infection Uncommon Nasopharyngitis, otitis media Immune system disorders Not known Anaphylactic reaction‡ Respiratory, thoracic and Rare Bronchospasm mediastinal disorders Gastrointestinal disorders Very common Diarrhoea, vomiting Uncommon Haematochezia†, Abdominal pain upper Very Rare Intussusception α * Not known Gastroenteritis‡ § Skin and subcutaneo

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HOS-154140 · has-contraindication-information · PDF-Seite 3

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Hypersensitivity after previous administration of rotavirus vaccines. Previous history of intussusception. Subjects with congenital malformation of the gastrointestinal tract that could predispose to intussusception. Infants who have known or suspected immunodeficiency (see sections 4.4 and 4.8). Administration of RotaTeq should be postponed in infants suffering from acute severe febrile illness. The presence of a minor infection is not a contraindication for immunisation. The administration of RotaTeq should be postponed in subjects suffering from acute diarrhoea or vomiting. 3

HOS-154139 · has-indication-information · PDF-Seite 2

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.

HOS-154142 · has-interaction-information · PDF-Seite 5

Co-administration of RotaTeq with vaccines containing one or more of the following antigens at approximately 2, 4 and 6 months of age demonstrated that the immune responses and the safety profiles of the administered vaccines were unaffected: - Diphtheria-tetanus-acellular pertussis vaccine (DTaP) - Haemophilus influenzae type b vaccine (Hib) - Inactivated poliomyelitis vaccine (IPV) - Hepatitis B vaccine (HBV) - Pneumococcal conjugate vaccine (PCV) Co-administration of RotaTeq with DTaP-IPV-HBV-Hib vaccine (Infanrix hexa) at approximately 2, 3, and 4 months of age demonstrated that the immune responses and the safety profiles of the co-administered vaccines were unaffected compared to separate administrations. Co-administration of RotaTeq with a group C meningococcal conjugate vaccine (MenCC, the vaccine studied was a tetanus toxoid conjugate) at 3 and 5 months of age (and mostly at the same time as DTaP-IPV-Hib vaccine), followed by a third dose of RotaTeq at approximately 6 months of age, demonstrated that the immune responses to RotaTeq and MenCC were unaffected. Co-administration resulted in an acceptable safety profile. Concomitant administration of RotaTeq and oral poliomyelitis vaccine (OPV) did not affect the immune response to the poliovirus antigens. Although concomitant administration of OPV slightly reduced the immune response to rotavirus vaccine, there is currently no evidence that clinical protection against severe rotavirus gastroenteritis would be affected. The immune response to RotaTeq was unaffected when OPV was administered two weeks after RotaTeq. Therefore, RotaTeq can be given concomitantly with monovalent or combination infant vaccines containing one or more of the following antigens: DTaP, Hib, IPV or OPV, HBV, PCV and MenCC.

HOS-154143 · has-pregnancy-information · PDF-Seite 5

RotaTeq is intended for use in infants only. Thus human data on use during pregnancy or lactation are not available and animal fertility or reproduction studies have not been performed. 5

HOS-154141 · has-warning-information · PDF-Seite 4

Traceability In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded. As with all vaccines, appropriate medical treatment should always be readily available in case of an anaphylactic event following the administration of the vaccine (see section 4.8). No safety or efficacy data are available from clinical trials regarding administration of RotaTeq to immunocompromised infants, those exposed in utero to an immunosuppressive treatment, infants infected with HIV or infants who have received a blood transfusion or immunoglobulins within 42 days of dosing. Asymptomatic HIV infection is not expected to affect the safety or efficacy of RotaTeq. However, in the absence of sufficient data, administration of RotaTeq to asymptomatic HIV- infected infants is not recommended. Administration of RotaTeq to infants who have been exposed in utero to an immunosuppressive treatment should be based on careful consideration of potential benefits and risks. Cases of gastroenteritis associated with vaccine virus have been reported post marketing in infants with severe combined immunodeficiency (SCID, see section 4.3). In trials, RotaTeq was shed in the stools of 8.9 % of vaccine recipients almost exclusively in the week after dose 1 and in only one vaccine recipient (0.3 %) after dose 3. Peak excretion occurred within 7 days of dosing. Transmission of vaccine virus strains to non-vaccinated contacts has been observed post-marketing. RotaTeq should be administered with caution to individuals with close contacts who are immunodeficient (e.g., individuals with malignancies or who are otherwise immunocompromised or individuals receiving immunosuppressive therapy). Also, those caring for recent vaccinees should observe careful hygiene especially when handling excreta. In a clinical study, RotaTeq was administered to approximately 1,000 infants who were born at a gestational age of 25 to 36 weeks. The first dose was administered from 6 weeks after birth. The safety and efficacy of RotaTeq were comparable between this subset of infants and infants born at term. However, 19 of the approximately 1,000 infants were born at a gestational age of 25 to 28 weeks, 55 were born at a gestational age of 29 to 31 weeks and the remainder was born at a gestational age of between 32 and 36 weeks. See sections 4.2 and 5.1. Intussusception As a precaution, healthcare professionals should follow-u

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