Prevenar 13 · 4.5 Interaction with other medicinal products and other forms of interaction · 3

HOS-095450 · has-adverse-reaction-information · PDF-Seite 32

Analysis of postmarketing reporting rates suggests a potential increased risk of convulsions, with or without fever, and HHE when comparing groups which reported use of Prevenar 13 with Infanrix hexa to those which reported use of Prevenar 13 alone. Adverse reactions reported in clinical studies or from the postmarketing experience for all age groups are listed in this section per system organ class, in decreasing order of frequency and seriousness. The frequency is defined as follows: 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 available data). Infants and children aged 6 weeks to 5 years The safety of the vaccine was assessed in controlled clinical studies where 14,267 doses were given to 4,429 healthy infants from 6 weeks of age at first vaccination and 11-16 months of age at booster dose. 32 In all infant studies, Prevenar 13 was co-administered with routine paediatric vaccines (see section 4.5). Safety in 354 previously unvaccinated children (7 months to 5 years of age) was also assessed. The most commonly reported adverse reactions in children 6 weeks to 5 years of age were vaccination-site reactions, fever, irritability, decreased appetite, and increased and/or decreased sleep. In a clinical study in infants vaccinated at 2, 3, and 4 months of age, fever ≥ 38°C was reported at higher rates among infants who received Prevenar (7-valent) concomitantly with Infanrix hexa (28.3% to 42.3%) than in infants receiving Infanrix hexa alone (15.6% to 23.1%). After a booster dose at 12 to 15 months of age, fever ≥ 38°C was reported in 50.0% of infants who received Prevenar (7-valent) and Infanrix hexa at the same time as compared to 33.6% of infants receiving Infanrix hexa alone. These reactions were mostly moderate (less than or equal to 39°C) and transient. An increase in vaccination-site reactions was reported in children older than 12 months compared to rates observed in infants during the primary series with Prevenar 13. Adverse reactions from clinical studies In clinical studies, the safety profile of Prevenar 13 was similar to Prevenar. The following frequencies are based on adverse reactions assessed in Prevenar 13 clinical studies: Immune system disorders: Rare: Hypersensitivity reaction including face oedema, dyspnoea, bronchospasm Nervous system d

Auszug; vollständigen Abschnitt im Original lesen.

HOS-095444 · has-adverse-reaction-information · PDF-Seite 7

Analysis of postmarketing reporting rates suggests a potential increased risk of convulsions, with or without fever, and HHE when comparing groups which reported use of Prevenar 13 with Infanrix hexa to those which reported use of Prevenar 13 alone. Adverse reactions reported in clinical studies or from the postmarketing experience for all age groups are listed in this section per system organ class, in decreasing order of frequency and seriousness. The frequency is defined as follows: 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 available data). 7 Infants and children aged 6 weeks to 5 years The safety of the vaccine was assessed in controlled clinical studies where 14,267 doses were given to 4,429 healthy infants from 6 weeks of age at first vaccination and 11-16 months of age at booster dose. In all infant studies, Prevenar 13 was co-administered with routine paediatric vaccines (see section 4.5). Safety in 354 previously unvaccinated children (7 months to 5 years of age) was also assessed. The most commonly reported adverse reactions in children 6 weeks to 5 years of age were vaccination-site reactions, fever, irritability, decreased appetite, and increased and/or decreased sleep. In a clinical study in infants vaccinated at 2, 3, and 4 months of age, fever ≥ 38°C was reported at higher rates among infants who received Prevenar (7-valent) concomitantly with Infanrix hexa (28.3% to 42.3%) than in infants receiving Infanrix hexa alone (15.6% to 23.1%). After a booster dose at 12 to 15 months of age, fever ≥ 38°C was reported in 50.0% of infants who received Prevenar (7-valent) and Infanrix hexa at the same time as compared to 33.6% of infants receiving Infanrix hexa alone. These reactions were mostly moderate (less than or equal to 39°C) and transient. An increase in vaccination-site reactions was reported in children older than 12 months compared to rates observed in infants during the primary series with Prevenar 13. Adverse reactions from clinical studies In clinical studies, the safety profile of Prevenar 13 was similar to Prevenar. The following frequencies are based on adverse reactions assessed in Prevenar 13 clinical studies: Immune system disorders: Rare: Hypersensitivity reaction including face oedema, dyspnoea, bronchospasm Nervous system

Auszug; vollständigen Abschnitt im Original lesen.

HOS-095456 · has-adverse-reaction-information · PDF-Seite 57

Analysis of postmarketing reporting rates suggests a potential increased risk of convulsions, with or without fever, and HHE when comparing groups which reported use of Prevenar 13 with Infanrix hexa to those which reported use of Prevenar 13 alone. Adverse reactions reported in clinical studies or from the postmarketing experience for all age groups are listed in this section per system organ class, in decreasing order of frequency and seriousness. The frequency is defined as follows: 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 available data). Infants and children aged 6 weeks to 5 years The safety of the vaccine was assessed in controlled clinical studies where 14,267 doses were given to 4,429 healthy infants from 6 weeks of age at first vaccination and 11-16 months of age at booster dose. 57 In all infant studies, Prevenar 13 was co-administered with routine paediatric vaccines (see section 4.5). Safety in 354 previously unvaccinated children (7 months to 5 years of age) was also assessed. The most commonly reported adverse reactions in children 6 weeks to 5 years of age were vaccination-site reactions, fever, irritability, decreased appetite, and increased and/or decreased sleep. In a clinical study in infants vaccinated at 2, 3, and 4 months of age, fever ≥ 38°C was reported at higher rates among infants who received Prevenar (7-valent) concomitantly with Infanrix hexa (28.3% to 42.3%) than in infants receiving Infanrix hexa alone (15.6% to 23.1%). After a booster dose at 12 to 15 months of age, fever ≥ 38°C was reported in 50.0% of infants who received Prevenar (7-valent) and Infanrix hexa at the same time as compared to 33.6% of infants receiving Infanrix hexa alone. These reactions were mostly moderate (less than or equal to 39°C) and transient. An increase in vaccination-site reactions was reported in children older than 12 months compared to rates observed in infants during the primary series with Prevenar 13. Adverse reactions from clinical studies In clinical studies, the safety profile of Prevenar 13 was similar to Prevenar. The following frequencies are based on adverse reactions assessed in Prevenar 13 clinical studies: Immune system disorders: Rare: Hypersensitivity reaction including face oedema, dyspnoea, bronchospasm Nervous system d

Auszug; vollständigen Abschnitt im Original lesen.

HOS-095446 · has-contraindication-information · PDF-Seite 29

Hypersensitivity to the active substances, to any of the excipients listed in section 6.1, or to diphtheria toxoid. As with other vaccines, the administration of Prevenar 13 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-095440 · has-contraindication-information · PDF-Seite 4

Hypersensitivity to the active substances, to any of the excipients listed in section 6.1, or to diphtheria toxoid. As with other vaccines, the administration of Prevenar 13 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-095452 · has-contraindication-information · PDF-Seite 54

Hypersensitivity to the active substances, to any of the excipients listed in section 6.1, or to diphtheria toxoid. As with other vaccines, the administration of Prevenar 13 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-095451 · has-indication-information · PDF-Seite 52

Active immunisation for the prevention of invasive disease, pneumonia and acute otitis media caused by Streptococcus pneumoniae in infants, children and adolescents from 6 weeks to 17 years of age. Active immunisation for the prevention of invasive disease and pneumonia caused by Streptococcus pneumoniae in adults ≥ 18 years of age and the elderly. See sections 4.4 and 5.1 for information on protection against specific pneumococcal serotypes. 52 The use of Prevenar 13 should be determined on the basis of official recommendations taking into consideration the risk of invasive disease and pneumonia in different age groups, underlying comorbidities as well as the variability of serotype epidemiology in different geographical areas.

HOS-095439 · has-indication-information · PDF-Seite 2

Active immunisation for the prevention of invasive disease, pneumonia and acute otitis media caused by Streptococcus pneumoniae in infants, children and adolescents from 6 weeks to 17 years of age. Active immunisation for the prevention of invasive disease and pneumonia caused by Streptococcus pneumoniae in adults ≥18 years of age and the elderly. See sections 4.4 and 5.1 for information on protection against specific pneumococcal serotypes. 2 The use of Prevenar 13 should be determined on the basis of official recommendations taking into consideration the risk of invasive disease and pneumonia in different age groups, underlying comorbidities as well as the variability of serotype epidemiology in different geographical areas.

HOS-095445 · has-indication-information · PDF-Seite 27

Active immunisation for the prevention of invasive disease, pneumonia and acute otitis media caused by Streptococcus pneumoniae in infants, children and adolescents from 6 weeks to 17 years of age. Active immunisation for the prevention of invasive disease and pneumonia caused by Streptococcus pneumoniae in adults ≥ 18 years of age and the elderly. See sections 4.4 and 5.1 for information on protection against specific pneumococcal serotypes. 27 The use of Prevenar 13 should be determined on the basis of official recommendations taking into consideration the risk of invasive disease and pneumonia in different age groups, underlying comorbidities as well as the variability of serotype epidemiology in different geographical areas.

HOS-095454 · has-interaction-information · PDF-Seite 56

Infants and children aged 6 weeks to 5 years Prevenar 13 can be given concomitantly with any of the following vaccine antigens, either as monovalent or combination vaccines: diphtheria, tetanus, acellular or whole cell pertussis, Haemophilus influenzae type b, inactivated poliomyelitis, hepatitis B (see section 4.4 for guidance on Infanrix hexa), meningococcal serogroup C, measles, mumps, rubella, varicella and rotavirus vaccine. Prevenar 13 can also be given concomitantly between 12-23 months with the tetanus toxoid conjugated meningococcal polysaccharide serogroups A, C, W and Y vaccine to children who have been adequately primed with Prevenar 13 (as per local recommendations). Data from a postmarketing clinical study evaluating the impact of prophylactic use of antipyretics (ibuprofen and paracetamol) on the immune response to Prevenar 13 suggest that administration of paracetamol concomitantly or within the same day of vaccination may reduce the immune response to Prevenar 13 after the infant series. Responses to the booster dose administered at 12 months were unaffected. The clinical significance of this observation is unknown. Children and adolescents 6 to 17 years of age No data are currently available regarding concomitant use with other vaccines. Adults 18 to 49 years of age No data are available regarding concomitant use with other vaccines. Adults aged 50 years and older Prevenar 13 may be administered concomitantly with the seasonal trivalent inactivated influenza vaccine (TIV). In two studies conducted in adults aged 50-59 and 65 years and older, it was demonstrated that Prevenar 13 may be given concomitantly with trivalent inactivated influenza vaccine (TIV). The responses to all three TIV antigens were comparable when TIV was given alone or concomitantly with Prevenar 13. When Prevenar 13 was given concomitantly with TIV, the immune responses to Prevenar 13 were lower compared to when Prevenar 13 was given alone, however, there was no long-term impact on circulating antibody levels. 56 In a third study in adults aged 50-93 years, it was demonstrated that Prevenar 13 may be given concomitantly with the seasonal quadrivalent inactivated influenza vaccine (QIV). The immune responses to all four QIV strains were noninferior when Prevenar 13 was given concomitantly with QIV compared to when QIV was given alone. The immune responses to Prevenar 13 were noninferior when Prevenar 13 w

Auszug; vollständigen Abschnitt im Original lesen.

HOS-095442 · has-interaction-information · PDF-Seite 6

Infants and children aged 6 weeks to 5 years Prevenar 13 can be given concomitantly with any of the following vaccine antigens, either as monovalent or combination vaccines: diphtheria, tetanus, acellular or whole cell pertussis, Haemophilus influenzae type b, inactivated poliomyelitis, hepatitis B (see section 4.4 for guidance on Infanrix hexa), meningococcal serogroup C, measles, mumps, rubella, varicella and rotavirus vaccine. Prevenar 13 can also be given concomitantly between 12-23 months with the tetanus toxoid conjugated meningococcal polysaccharide serogroups A, C, W and Y vaccine to children who have been adequately primed with Prevenar 13 (as per local recommendations). Data from a postmarketing clinical study evaluating the impact of prophylactic use of antipyretics (ibuprofen and paracetamol) on the immune response to Prevenar 13 suggest that administration of paracetamol concomitantly or within the same day of vaccination may reduce the immune response to Prevenar 13 after the infant series. Responses to the booster dose administered at 12 months were unaffected. The clinical significance of this observation is unknown. Children and adolescents 6 to 17 years of age No data are currently available regarding concomitant use with other vaccines. Adults 18 to 49 years of age No data are available regarding concomitant use with other vaccines. Adults aged 50 years and older Prevenar 13 may be administered concomitantly with the seasonal trivalent inactivated influenza vaccine (TIV). In two studies conducted in adults aged 50-59 and 65 years and older, it was demonstrated that Prevenar 13 may be given concomitantly with trivalent inactivated influenza vaccine (TIV). The responses to all three TIV antigens were comparable when TIV was given alone or concomitantly with Prevenar 13. When Prevenar 13 was given concomitantly with TIV, the immune responses to Prevenar 13 were lower compared to when Prevenar 13 was given alone, however, there was no long-term impact on circulating antibody levels. 6 In a third study in adults aged 50-93 years, it was demonstrated that Prevenar 13 may be given concomitantly with the seasonal quadrivalent inactivated influenza vaccine (QIV). The immune responses to all four QIV strains were noninferior when Prevenar 13 was given concomitantly with QIV compared to when QIV was given alone. The immune responses to Prevenar 13 were noninferior when Prevenar 13 wa

Auszug; vollständigen Abschnitt im Original lesen.

HOS-095448 · has-interaction-information · PDF-Seite 31

Infants and children aged 6 weeks to 5 years Prevenar 13 can be given concomitantly with any of the following vaccine antigens, either as monovalent or combination vaccines: diphtheria, tetanus, acellular or whole cell pertussis, Haemophilus influenzae type b, inactivated poliomyelitis, hepatitis B (see section 4.4 for guidance on Infanrix hexa), meningococcal serogroup C, measles, mumps, rubella, varicella and rotavirus vaccine. Prevenar 13 can also be given concomitantly between 12-23 months with the tetanus toxoid conjugated meningococcal polysaccharide serogroups A, C, W and Y vaccine to children who have been adequately primed with Prevenar 13 (as per local recommendations). Data from a postmarketing clinical study evaluating the impact of prophylactic use of antipyretics (ibuprofen and paracetamol) on the immune response to Prevenar 13 suggest that administration of paracetamol concomitantly or within the same day of vaccination may reduce the immune response to Prevenar 13 after the infant series. Responses to the booster dose administered at 12 months were unaffected. The clinical significance of this observation is unknown. Children and adolescents 6 to 17 years of age No data are currently available regarding concomitant use with other vaccines. Adults 18 to 49 years of age No data are available regarding concomitant use with other vaccines. Adults aged 50 years and older Prevenar 13 may be administered concomitantly with the seasonal trivalent inactivated influenza vaccine (TIV). In two studies conducted in adults aged 50-59 and 65 years and older, it was demonstrated that Prevenar 13 may be given concomitantly with trivalent inactivated influenza vaccine (TIV). The responses to all three TIV antigens were comparable when TIV was given alone or concomitantly with Prevenar 13. When Prevenar 13 was given concomitantly with TIV, the immune responses to Prevenar 13 were lower compared to when Prevenar 13 was given alone, however, there was no long-term impact on circulating antibody levels. 31 In a third study in adults aged 50-93 years, it was demonstrated that Prevenar 13 may be given concomitantly with the seasonal quadrivalent inactivated influenza vaccine (QIV). The immune responses to all four QIV strains were noninferior when Prevenar 13 was given concomitantly with QIV compared to when QIV was given alone. The immune responses to Prevenar 13 were noninferior when Prevenar 13 w

Auszug; vollständigen Abschnitt im Original lesen.

HOS-095455 · has-pregnancy-information · PDF-Seite 57

Pregnancy There are no data from the use of pneumococcal 13-valent conjugate vaccine in pregnant women. Therefore the use of Prevenar 13 should be avoided during pregnancy. Breast-feeding It is unknown whether pneumococcal 13-valent conjugate vaccine is excreted in human milk. Fertility Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3).

HOS-095443 · has-pregnancy-information · PDF-Seite 7

Pregnancy There are no data from the use of pneumococcal 13-valent conjugate vaccine in pregnant women. Therefore the use of Prevenar 13 should be avoided during pregnancy. Breast-feeding It is unknown whether pneumococcal 13-valent conjugate vaccine is excreted in human milk. Fertility Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3).

HOS-095449 · has-pregnancy-information · PDF-Seite 32

Pregnancy There are no data from the use of pneumococcal 13-valent conjugate vaccine in pregnant women. Therefore the use of Prevenar 13 should be avoided during pregnancy. Breast-feeding It is unknown whether pneumococcal 13-valent conjugate vaccine is excreted in human milk. Fertility Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3).

HOS-095453 · has-warning-information · PDF-Seite 54

Prevenar 13 must not be administered intravascularly. As with all injectable vaccines, appropriate medical treatment and supervision should always be readily available in case of a rare anaphylactic event following the administration of the vaccine. This vaccine should not be given as an intramuscular injection to individuals with thrombocytopaenia or any coagulation disorder that would contraindicate intramuscular injection, but may be given subcutaneously if the potential benefit clearly outweighs the risks (see section 5.1). 54 Prevenar 13 will only protect against Streptococcus pneumoniae serotypes included in the vaccine, and will not protect against other microorganisms that cause invasive disease, pneumonia, or otitis media. As with any vaccine, Prevenar 13 may not protect all individuals receiving the vaccine from pneumococcal disease. For the most recent epidemiological information in your country you should consult with the relevant national organisation. Individuals with impaired immune responsiveness, whether due to the use of immuno-suppressive therapy, a genetic defect, human immunodeficiency virus (HIV) infection, or other causes, may have reduced antibody response to active immunisation. Safety and immunogenicity data are available for a limited number of individuals with sickle cell disease, HIV infection, or with an haematopoietic stem cell transplant (see section 5.1). Safety and immunogenicity data for Prevenar 13 are not available for individuals in other specific immuno-compromised groups (e.g., malignancy or nephrotic syndrome) and vaccination should be considered on an individual basis. Excipients This medicinal product contains polysorbate 80 (see section 2). Polysorbate 80 may cause hypersensitivity reactions. This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially ‘sodium-free’. Infants and children aged 6 weeks to 5 years In clinical studies, Prevenar 13 elicited an immune response to all thirteen serotypes included in the vaccine. The immune response for serotype 3 following the booster dose was not increased above the levels seen after the infant vaccination series; the clinical relevance of this observation regarding the induction of serotype 3 immune memory is unknown (see section 5.1). The proportions of functional antibody responders (OPA titres ≥ 1:8) to serotypes 1, 3 and 5 were high. However, the OPA geometric mean titres we

Auszug; vollständigen Abschnitt im Original lesen.

HOS-095447 · has-warning-information · PDF-Seite 29

Prevenar 13 must not be administered intravascularly. As with all injectable vaccines, appropriate medical treatment and supervision should always be readily available in case of a rare anaphylactic event following the administration of the vaccine. This vaccine should not be given as an intramuscular injection to individuals with thrombocytopaenia or any coagulation disorder that would contraindicate intramuscular injection, but may be given subcutaneously if the potential benefit clearly outweighs the risks (see section 5.1). 29 Prevenar 13 will only protect against Streptococcus pneumoniae serotypes included in the vaccine, and will not protect against other microorganisms that cause invasive disease, pneumonia, or otitis media. As with any vaccine, Prevenar 13 may not protect all individuals receiving the vaccine from pneumococcal disease. For the most recent epidemiological information in your country you should consult with the relevant national organisation. Individuals with impaired immune responsiveness, whether due to the use of immuno-suppressive therapy, a genetic defect, human immunodeficiency virus (HIV) infection, or other causes, may have reduced antibody response to active immunisation. Safety and immunogenicity data are available for a limited number of individuals with sickle cell disease, HIV infection, or with an haematopoietic stem cell transplant (see section 5.1). Safety and immunogenicity data for Prevenar 13 are not available for individuals in other specific immuno-compromised groups (e.g., malignancy or nephrotic syndrome) and vaccination should be considered on an individual basis. Excipients This medicinal product contains polysorbate 80 (see section 2). Polysorbate 80 may cause hypersensitivity reactions. This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially ‘sodium-free’. Infants and children aged 6 weeks to 5 years In clinical studies, Prevenar 13 elicited an immune response to all thirteen serotypes included in the vaccine. The immune response for serotype 3 following the booster dose was not increased above the levels seen after the infant vaccination series; the clinical relevance of this observation regarding the induction of serotype 3 immune memory is unknown (see section 5.1). The proportions of functional antibody responders (OPA titres ≥ 1:8) to serotypes 1, 3 and 5 were high. However, the OPA geometric mean titres we

Auszug; vollständigen Abschnitt im Original lesen.

HOS-095441 · has-warning-information · PDF-Seite 4

Prevenar 13 must not be administered intravascularly. As with all injectable vaccines, appropriate medical treatment and supervision should always be readily available in case of a rare anaphylactic event following the administration of the vaccine. This vaccine should not be given as an intramuscular injection to individuals with thrombocytopaenia or any coagulation disorder that would contraindicate intramuscular injection, but may be given subcutaneously if the potential benefit clearly outweighs the risks (see section 5.1). 4 Prevenar 13 will only protect against Streptococcus pneumoniae serotypes included in the vaccine, and will not protect against other microorganisms that cause invasive disease, pneumonia, or otitis media. As with any vaccine, Prevenar 13 may not protect all individuals receiving the vaccine from pneumococcal disease. For the most recent epidemiological information in your country you should consult with the relevant national organisation. Individuals with impaired immune responsiveness, whether due to the use of immuno-suppressive therapy, a genetic defect, human immunodeficiency virus (HIV) infection, or other causes, may have reduced antibody response to active immunisation. Safety and immunogenicity data are available for a limited number of individuals with sickle cell disease, HIV infection, or with an haematopoietic stem cell transplant (see section 5.1). Safety and immunogenicity data for Prevenar 13 are not available for individuals in other specific immuno-compromised groups (e.g., malignancy or nephrotic syndrome) and vaccination should be considered on an individual basis. Excipients This medicinal product contains polysorbate 80 (see section 2). Polysorbate 80 may cause hypersensitivity reactions. This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially ‘sodium-free’. Infants and children aged 6 weeks to 5 years In clinical studies, Prevenar 13 elicited an immune response to all thirteen serotypes included in the vaccine. The immune response for serotype 3 following the booster dose was not increased above the levels seen after the infant vaccination series; the clinical relevance of this observation regarding the induction of serotype 3 immune memory is unknown (see section 5.1). The proportions of functional antibody responders (OPA titres ≥ 1:8) to serotypes 1, 3 and 5 were high. However, the OPA geometric mean titres we

Auszug; vollständigen Abschnitt im Original lesen.