Rotarix · 4.8 Undesirable effects · 1

HOS-094220 · has-adverse-reaction-information · PDF-Seite 5

Summary of the safety profile The safety profile presented below is based on data from clinical trials conducted with either the lyophilised or the liquid formulation of Rotarix. In a total of four clinical trials, approximately 3 800 doses of Rotarix liquid formulation were administered to approximately 1 900 infants. Those trials have shown that the safety profile of the liquid formulation is comparable to the lyophilised formulation. In a total of twenty-three clinical trials, approximately 106 000 doses of Rotarix (lyophilised or liquid formulation) were administered to approximately 51 000 infants. In three placebo-controlled clinical trials (Finland, India and Bangladesh), in which Rotarix was administered alone (administration of routine paediatric vaccines was staggered), the incidence and severity of the solicited events (collected 8 days post-vaccination), diarrhoea, vomiting, loss of appetite, fever, irritability and cough/runny nose were not significantly different in the group receiving Rotarix when compared to the group receiving placebo. No increase in the incidence or severity of these events was seen with the second dose. In a pooled analysis from seventeen placebo-controlled clinical trials (Europe, North America, Latin America, Asia, Africa) including trials in which Rotarix was co-administered with routine paediatric vaccines (see section 4.5), the following adverse reactions (collected 31 days post-vaccination) were considered as possibly related to vaccination. 5 Tabulated list of adverse reactions Adverse reactions reported from clinical studies, post-marketing surveillance and spontaneous reporting are listed according to the following frequency: Frequencies are reported as: Very common ( 1/10) Common ( 1/100 to < 1/10) Uncommon ( 1/1 000 to < 1/100) Rare ( 1/10 000 to < 1/1 000) Very rare (< 1/10 000) Not known (cannot be estimated from the available data) System Organ Class Frequency Adverse reactions Immune system disorders Not known Anaphylactic reaction1 Gastrointestinal disorders Common Diarrhoea Uncommon Abdominal pain, flatulence Very rare Intussusception (see section 4.4)

Auszug; vollständigen Abschnitt im Original lesen.

HOS-094216 · 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. History of intussusception. Individuals with uncorrected congenital malformation of the gastrointestinal tract that would predispose for intussusception. Individuals with Severe Combined Immunodeficiency (SCID) disorder (see section 4.8). Administration of Rotarix should be postponed in individuals suffering from acute severe febrile illness. The presence of a minor infection is not a contra-indication for immunisation. The administration of Rotarix should be postponed in individuals suffering from diarrhoea or vomiting.

HOS-094215 · has-indication-information · PDF-Seite 2

Rotarix is indicated for the active immunisation of infants aged 6 to 24 weeks for prevention of gastro- enteritis due to rotavirus infection (see sections 4.2, 4.4 and 5.1). The use of Rotarix should be based on official recommendations.

HOS-094218 · has-interaction-information · PDF-Seite 5

Rotarix can be given concomitantly with any of the following monovalent or combination vaccines [including hexavalent vaccines (DTPa-HBV-IPV/Hib)]: diphtheria-tetanus-whole cell pertussis vaccine (DTPw), diphtheria-tetanus-acellular pertussis vaccine (DTPa), Haemophilus influenzae type b vaccine (Hib), inactivated polio vaccine (IPV), hepatitis B vaccine (HBV), pneumococcal conjugate vaccine and meningococcal serogroup C conjugate vaccine. Clinical studies demonstrated that the immune responses and the safety profiles of the administered vaccines were unaffected. Concomitant administration of Rotarix and oral polio vaccine (OPV) does not affect the immune response to the polio antigens. Although concomitant administration of OPV may slightly reduce the immune response to rotavirus vaccine, clinical protection against severe rotavirus gastro-enteritis was shown to be maintained in a clinical trial involving more than 4 200 participants who received Rotarix concomitantly with OPV. There are no restrictions on the infant’s consumption of food or liquid, either before or after vaccination.

HOS-094219 · has-pregnancy-information · PDF-Seite 5

Rotarix is not intended for use in adults. There are no data on the use of Rotarix during pregnancy and lactation. Based on evidence generated in clinical trials, breast-feeding does not reduce the protection against rotavirus gastro-enteritis afforded by Rotarix. Therefore, breast-feeding may be continued during the vaccination schedule.

HOS-094217 · has-warning-information · PDF-Seite 3

It is good clinical practice that vaccination should be preceded by a review of the medical history especially with regard to the contraindications and by a clinical examination. Appropriate medical treatment should always be readily available in case of an anaphylactic event following the administration of the vaccine (see section 4.8). There are no data on the safety and efficacy of Rotarix in infants with gastrointestinal illnesses or growth retardation. Administration of Rotarix may be considered with caution in such infants when, in the opinion of the physician, withholding the vaccine entails a greater risk. As a precaution, healthcare professionals should follow-up on any symptoms indicative of intussusception (severe abdominal pain, persistent vomiting, bloody stools, abdominal bloating and/or high fever) since data from observational safety studies indicate an increased risk of intussusception, mostly within 7 days after rotavirus vaccination (see section 4.8). Parents/guardians should be advised to promptly report such symptoms to their healthcare provider. For individuals with a predisposition for intussusception, see section 4.3. Asymptomatic and mildly symptomatic HIV infections are not expected to affect the safety or efficacy of Rotarix. A clinical study in a limited number of asymptomatic or mildly symptomatic HIV positive infants showed no apparent safety problems (see section 4.8). 3 Administration of Rotarix to infants who have known or suspected immunodeficiency, including in utero exposure to an immunosuppressive treatment, should be based on careful consideration of potential benefits and risks. Excretion of the vaccine virus in the stools is known to occur after vaccination with peak excretion around the 7th day. Viral antigen particles detected by ELISA were found in 50% of stools after the first dose of Rotarix lyophilised formulation and 4% of stools after the second dose. When these stools were tested for the presence of live vaccine strain, only 17% were positive. In two comparative controlled trials, vaccine shedding after vaccination with Rotarix liquid formulation was comparable to that observed after vaccination with Rotarix lyophilised formulation. Cases of transmission of this excreted vaccine virus to seronegative contacts of vaccinees have been observed without causing any clinical symptom. Rotarix should be administered with caution to individuals with i

Auszug; vollständigen Abschnitt im Original lesen.