Prevenar 13

Prevenar 13

vaccine, pneumococcal

Manufacturer:

Pfizer
Concise Prescribing Info
Contents
Pneumococcal polysaccharide conjugated vaccine (13-valent, adsorbed)
Indications/Uses
Childn 6 wk-5 yr: Active immunization for prevention of invasive disease, pneumonia & acute otitis media caused by Strep pneumoniae in infant & childn from 6 wk-5 yr. Adult ≥50 yr: Active immunization for prevention of pneumococcal disease (including pneumonia & invasive disease) in adults ≥50 yr caused by Strep pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F & 23F.
Dosage/Direction for Use
IM 0.5 mL (1 dose). Adult ≥50 yr & those previously vaccinated w/ pneumococcal polysaccharide vaccine, childn 2-5 yr previously vaccinated w/ Prevenar (7 valent) 1 single dose. Childn 12-23 mth 2 doses w/ at least 2 mth interval between doses. Unvaccinated childn 2-5 yr 1 single dose of 0.5 mL, 12-23 mth 2 doses of 0.5 mL w/ at least 2 mth interval between doses, infant 7-11 mth 2 doses of 0.5 mL w/ at least 1 mth interval, followed by 3rd dose at 2 yr. Infant 6 wk-6 mth 3-dose primary series: 1st dose given at 2 mth of age w/ at least 1-mth interval between doses, may be given as early as 6 wk of age. 4th dose (booster) given between 11 & 15 mth of age. 2-dose primary series: Routine infant immunization program: 1st dose given at 2 mth of age & the 2nd dose is 2 mth later. 3rd dose (booster) given between 11 & 15 mth of age. Preterm infant (<37 wk gestation) 1st dose given at 2 mth of age & w/ at least 1 mth interval between doses, may be given as early as 6 wk of age. 4th dose (booster) is recommended at approx 12 mth of age. Patients at higher risk of pneumococcal infection & previously vaccinated w/ 23-valent pneumococcal polysaccharide vaccine (PPSV23) 2 doses w/ 6 mth interval between doses. Naive individuals 2 doses w/ 1 mth interval between doses.
Contraindications
Hypersensitivity to pneumococcal polysaccharide conjugated vaccine (13-valent, adsorbed), diphtheria toxoid. Acute, severe febrile illness.
Special Precautions
Not to be inj in the gluteal area. Not for intravascular administration. Not to be given in patients w/ thrombocytopenia, any coagulation disorder or to those receiving anticoagulant therapy. Not for protection against invasive disease, pneumonia or otitis media due to other microorganism. Impaired immune responsiveness eg, under immunosuppressive therapy, genetic defect, HIV infection, or other causes may have reduced antibody response to active immunization. Individuals w/ malignancy, hematopoetic stem, nephrotic syndrome. Vaccination should be considered on an individual basis. Childn ≥24 mth w/ asthma, DM, sickle cell disease, asplenia, HIV infection, chronic illness, or those who are immunocompromised. Potential risk of apnoea; monitor resp for 48-72 hr when administering primary immunization series to very premature infants (≤28 wk of gestation) & those w/ history of resp immaturity. Initiate antipyretic treatment to childn w/ seizure disorders or w/ history of febrile seizures & for all childn receiving concomitant vaccine containing whole cell pertussis. Concomitant use w/ DTPa HBV-IPV/Hib vaccine. May temporarily affect the ability to drive or use machines. Childn <6 wk.
Adverse Reactions
Decreased appetite; diarrhea; rash; inj site erythema, induration/swelling, pain/tenderness; limitation of arm movement. Vomiting; fever >39°C. Childn 6 wk-5 yr: Drowsiness/increased sleep, restless/decreased sleep; pyrexia, irritability, somnolence, poor quality sleep. Adult ≥50 yr: Headaches; generalized new/aggravated joint pain, muscle pain; chills, fatigue.
Drug Interactions
Childn 6 wk-5 yr: May reduce immune response w/ paracetamol in infants. Different vaccine should be given in different inj site. Adult ≥50 yr: Use different syringes & give at different inj sites if co-administered w/ another vaccine. Do not mix w/ other vaccines/products in the same syringe.
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 susp inj
Packing/Price
((4 x 0.5 mL doses vial)) 2 mL x 50 × 1's; (1 dose vial) 0.5 mL x 50 × 1's; (pre-filled syringe) 0.5 mL x 1's
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