Synflorix · 4.6 Fertility, pregnancy and lactation · 1

HOS-095200 · has-adverse-reaction-information · PDF-Seite 6

Summary of the safety profile Safety assessment of Synflorix was based on clinical trials involving the administration of 63 905 doses of Synflorix to 22 429 healthy children and 137 preterm infants as primary vaccination. Furthermore, 19 466 children and 116 preterm infants received a booster dose of Synflorix in the second year of life. 6 Safety was also assessed in 435 previously unvaccinated children from 2 to 5 years old of which 285 subjects received 2 doses of Synflorix. In all trials, Synflorix was administered concurrently with the recommended childhood vaccines. In infants, the most common adverse reactions observed after primary vaccination were redness at the injection site and irritability which occurred after approximately 41% and 55% of all doses respectively. Following booster vaccination, the most common adverse reactions were pain at the injection site and irritability, which occurred at approximately 51% and 53% respectively. The majority of these reactions were of mild to moderate severity and were not long lasting. No increase in the incidence or severity of the adverse reactions was seen with subsequent doses of the primary vaccination series. Local reactogenicity of primary vaccination course was similar in infants < 12 months of age and in children > 12 months of age except for injection site pain for which the incidence increased with increasing age: pain was reported by more than 39% of the infants < 12 months of age and by more than 58% of the children > 12 months of age. Following booster vaccination, children > 12 months of age are more likely to experience injection site reactions compared to the rates observed in infants during the primary series with Synflorix. Following catch-up vaccination in children 12 to 23 months of age, urticaria was reported more frequently (uncommon) compared to the rates observed in infants during primary and booster vaccination. Reactogenicity was higher in children receiving whole cell pertussis vaccines concomitantly. In a clinical study children received either Synflorix (N = 603) or 7-valent Prevenar (N = 203) concomitantly with a DTPw containing vaccine. After the primary vaccination course, fever ≥ 38 °C and > 39 °C was reported respectively in 86.1% and 14.7% of children receiving Synflorix and in 82.9% and 11.6% of children vaccinated with 7-valent Prevenar. In comparative clinical studies, the incidence of local and general adve

Auszug; vollständigen Abschnitt im Original lesen.

HOS-095196 · has-contraindication-information · PDF-Seite 4

Hypersensitivity to the active substances or to any of the excipients listed in section 6.1, or to any of the carrier proteins. As with other vaccines, the administration of Synflorix should be postponed in subjects suffering from acute severe febrile illness. However, the presence of a minor infection, such as a cold, should not result in the deferral of vaccination.

HOS-095195 · has-indication-information · PDF-Seite 2

Active immunisation against invasive disease, pneumonia and acute otitis media caused by Streptococcus pneumoniae in infants and children from 6 weeks up to 5 years of age. See sections 4.4 and 5.1 for information on protection against specific pneumococcal serotypes. The use of Synflorix should be determined on the basis of official recommendations taking into consideration the impact on pneumococcal diseases in different age groups as well as the variability of the epidemiology in different geographical areas. 2

HOS-095198 · has-interaction-information · PDF-Seite 6

Use with other vaccines Synflorix can be given concomitantly with any of the following monovalent or combination vaccines [including DTPa-HBV-IPV/Hib and DTPw-HBV/Hib]: diphtheria-tetanus-acellular pertussis vaccine (DTPa), hepatitis B vaccine (HBV), inactivated polio vaccine (IPV), Haemophilus influenzae type b vaccine (Hib), diphtheria-tetanus-whole cell pertussis vaccine (DTPw), measles-mumps-rubella vaccine (MMR), varicella vaccine (V), meningococcal serogroup C conjugate vaccine (CRM197 and TT conjugates), meningococcal serogroups A, C, W-135 and Y conjugate vaccine (TT conjugate), oral polio vaccine (OPV) and oral rotavirus vaccine. Different injectable vaccines should always be given at different injection sites. Clinical studies demonstrated that the immune responses and the safety profiles of the co-administered vaccines were unaffected, with the exception of the inactivated poliovirus type 2 response, for which inconsistent results were observed across studies (seroprotection ranging from 78% to 100%). In addition when the meningococcal serogroups A, C, W-135 and Y vaccine (TT conjugate) was co- administered with a booster dose of Synflorix during the second year of life in children primed with 3 doses of Synflorix, lower antibody geometric mean concentration (GMC) and opsonophagocytic assay geometric mean titre (OPA GMT) were observed for one pneumococcal serotype (18 C). There was no impact of co-administration on the other nine pneumococcal serotypes. Enhancement of antibody response to Hib-TT conjugate, diphtheria and tetanus antigens was observed. The clinical relevance of the above observations is unknown. Use with systemic immunosuppressive medicinal products As with other vaccines, it may be expected that in patients receiving immunosuppressive treatment an adequate response may not be elicited. Use with prophylactic administration of antipyretics Clinical data suggest that prophylactic administration of paracetamol, used to reduce the rate of possible post-vaccination febrile reactions, might reduce the immune response to Synflorix. However, the clinical relevance of this observation is not known. See section 4.4.

HOS-095199 · has-pregnancy-information · PDF-Seite 6

Synflorix is not intended for use in adults. Human data on the use during pregnancy or breast-feeding and animal reproduction studies are not available.

HOS-095197 · 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. Prior to immunisation As with all injectable vaccines, appropriate medical treatment and supervision should always be readily available in case of a rare anaphylactic reaction following the administration of the vaccine. The potential risk of apnoea and the need for respiratory monitoring for 48–72 h should be considered when administering the primary immunisation series to very premature infants (born ≤ 28 weeks of gestation) and particularly for those with a previous history of respiratory immaturity. As the benefit of vaccination is high in this group of infants, vaccination should not be withheld or delayed. Synflorix should under no circumstances be administered intravascularly or intradermally. No data are available on subcutaneous administration of Synflorix. In children as of 2 years of age, syncope (fainting) can occur following, or even before, any vaccination as a psychogenic response to the needle injection. It is important that procedures are in place to avoid injury from faints. As for other vaccines administered intramuscularly, Synflorix should be given with caution to individuals with thrombocytopenia or any coagulation disorder since bleeding may occur following an intramuscular administration to these subjects. Information on protection conferred by the vaccine Official recommendations for the immunisation against diphtheria, tetanus and Haemophilus influenzae type b should also be followed. There is insufficient evidence that Synflorix provides protection against pneumococcal serotypes not contained in the vaccine except the cross-reactive serotype 19A (see section 5.1) or against non- typeable Haemophilus influenzae. Synflorix does not provide protection against other micro- organisms. 4 As with any vaccine, Synflorix may not protect all vaccinated individuals against invasive pneumococcal disease, pneumonia or otitis media caused by the serotypes in the vaccine and the cross-reactive serotype 19A. In addition, as otitis media and pneumonia are caused by many micro- organisms other than the Streptococcus pneumoniae serotypes represented by the vaccine, the overall protection against these diseases is expected to be limited and substantially lower than protection against invasive disease caused by the ser

Auszug; vollständigen Abschnitt im Original lesen.