Manufacturer
PFIZER IRELAND PHARMACEUTICALS
Contents
Pneumococcal 13-valent conjugate vaccine
Indication
Active immunisation for the prevention of pneumococcal disease caused by Strep pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F & 23F including invasive pneumococcal disease, pneumonia & acute otitis media in infants, childn & adolescents from 2 mth-17 yr & in adults ≥18 yr.
Instruction
IM 0.5 mL (1 dose). Adult ≥18 yr & those previously vaccinated w/ pneumococcal polysaccharide vaccine, childn & adolescents 2-17 yr, young childn, adolescent 1-17 yr completely immunised w/ Prevanar & childn & infant previously vaccinated w/ Prevanar (7 valent) 0.5 mL as single dose. Childn 12-23 mth 2 doses of 0.5 mL w/ at least 2-mth interval between doses. Infant 7-11 mth & unvaccinated infant 2 doses of 0.5 mL w/ at least 1-mth interval between doses, followed by 3rd dose in the 2nd yr, 2-6 mth & preterm infant <37 wk gestation 3-dose primary series: 1st dose given at 2 mth w/ at least 1-mth interval between doses, may be given as early as 6 wk. Booster dose given between 11-15 mth. Infant immunisation programme 1st dose given at 2 mth w/ 2nd dose given 2 mth later. Booster dose given between 11-15 mth.
Drug interaction
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 Precautions 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 post-marketing 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.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 was given concomitantly with QIV compared to when Prevenar 13 was given alone. As with concomitant administration with trivalent vaccines, immune responses to some pneumococcal serotypes were lower when both vaccines were given concomitantly.Concomitant use with other vaccines has not been investigated.Different injectable vaccines should always be given at different injection sites.Concomitant administration of Prevenar 13 and 23-valent pneumococcal polysaccharide vaccine has not been studied. In clinical studies when Prevenar 13 was given 1 year after 23-valent polysaccharide vaccine, the immune responses were lower for all serotypes compared to when Prevenar 13 was given to subjects not previously immunized with 23-valent polysaccharide vaccine. The clinical significance of this is unknown.
Malaysia
