Prevenar 13

Prevenar 13

vaccine, pneumococcal

Manufacturer:

Pfizer

Distributor:

Zuellig Pharma
Concise Prescribing Info
Contents
Pneumococcal 13-valent conjugate vaccine
Indications/Uses
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.
Dosage/Direction for Use
IM 0.5 mL (1 dose). Adult ≥18 yr & those previously vaccinated w/ pneumococcal polysaccharide vaccine, childn & adolescent 2-17 yr, young childn, adolescent 1-17 yr completely immunised w/ Prevenar & childn & infant previously vaccinated w/ Prevenar (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.
Contraindications
Hypersensitivity to the vaccine or diphtheria toxoid. Postpone vaccination in patients w/ acute severe febrile illness.
Special Precautions
Not to be inj intravascularly. Not to be inj IM in patients w/ thrombocytopenia or any coagulation disorder. Not for protection against invasive disease, pneumonia or otitis media due to other microorganism. Immunocompromised patients. Increased rate of convulsion (w/ or w/o fever) & hypotonic hyporesponsive episode w/ concomitant use of Infanrix Hexa. May temporarily affect ability to drive and use machines. Avoid use during pregnancy. Lactation. Risk of apnoea in very premature infant (≤28 wk of gestation); consider resp monitoring for 48-72 hr after primary immunisation.
Adverse Reactions
Pyrexia, inj site reactions eg, erythema, induration/swelling, pain/tenderness, impaired movement, decreased appetite. Vomiting, diarrhea, rash. Adolescents 6-17 yr, childn 6 wk-5 yr & infants: Somnolence, poor quality sleep, irritability. Infants & childn 6 wk-5 yr: Increased &/or decreased sleep. Childn & adolescents 6-17 yr: Urticaria or urticaria-like rash. Adults ≥18 yr, childn & adolescents 6-17 yr: Headache. Adults ≥18 yr: Arthralgia, myalgia; chills, fatigue, limited arm movement.
Drug Interactions
Reduced immune response w/ paracetamol in infants.
MIMS Class
Vaccines, Antisera & Immunologicals
ATC Classification
J07AL02 - pneumococcus, purified polysaccharides antigen conjugated ; Belongs to the class of pneumococcal bacterial vaccines.
Presentation/Packing
Form
Prevenar 13 vaccine (inj) (pre-filled syringe) 0.5 mL
Packing/Price
1's
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