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Prevnar 20

Prevnar 20

vaccine, pneumococcal

Manufacturer:

Pfizer

Distributor:

Zuellig Pharma

Marketer:

Pfizer
Concise Prescribing Info
Contents
Pneumococcal polysaccharide conjugate vaccine (20-valent, adsorbed)
Indications/Uses
Active immunisation for the prevention of invasive disease, pneumonia, & acute otitis media caused by Strep pneumoniae in infants, childn & adolescents from 6 wk to <18 yr; invasive disease & pneumonia caused by Strep pneumoniae in individuals ≥18 yr.
Dosage/Direction for Use
IM 0.5 mL (1 dose). Individual ≥18 yr, unvaccinated childn 2 to <5 yr 1 single dose. Infant & childn 6 wk to 15 mth, preterm infant <37 wk of gestation 3 dose primary series w/ 1st dose given at 2 mth w/ at least 4 wk interval between doses. 1st dose may be given as early as 6 wk. 4th (booster) dose is recommended between 11-15 mth. Unvaccinated childn 12 to <24 mth 2 doses w/ at least 8 wk interval between doses. Unvaccinated infant 7 to <12 mth 2 doses w/ at least 4 wk interval between doses. 3rd dose is recommended in the 2nd yr. Childn & adolescent 5 to <18 yr regardless of prior Prevnar 13, childn 15 mth to <5 yr previously fully vaccinated w/ Prevnar 13 1 single dose given on an individual basis, & at least 8 wk should elapse before administering Prevnar 20.
Contraindications
Hypersensitivity to pneumococcal polysaccharide conjugate vaccine or diphtheria toxoid.
Special Precautions
Not to be inj intravascularly. Appropriate medical treatment & supervision must be available in case of rare anaphylactic reaction following vaccination. Postpone vaccination in individuals suffering from acute severe febrile illness. Not for protection against other microorganisms that cause invasive disease, pneumonia or otitis media. Individuals w/ thrombocytopenia or bleeding disorder; carefully evaluate risk of bleeding in patients w/ coagulation disorders before IM vaccination. May only protect against Strep pneumoniae serotypes included in vaccine & will not protect against other microorganisms that cause invasive disease, pneumonia or otitis media; may not protect all individuals receiving vaccine from invasive pneumococcal disease, pneumonia or otitis media. May have reduced immune responses to Prevnar 20 in some individuals w/ altered immunocompetence; Ab response to active immunisation in individuals w/ impaired immune response due to immunosuppressive therapy, genetic defect, HIV infection or other causes. May temporarily affect ability to drive or use machines. Pregnancy & lactation. Risk of apnoea in very premature infant (≤28 wk of gestation), & particularly for those w/ previous history of resp immaturity; consider resp monitoring for 48-72 hr after primary immunisation. Infant <6 wk.
Adverse Reactions
Decreased appetite; vaccination site erythema, induration/swelling or pain/tenderness. Vaccination site pain/tenderness causing limitation of limb movement. Adolescents <18 yr, infants & childn 6 wk to 5 yr: Irritability; drowsiness/increased sleep; restless/decreased sleep. Diarrhoea; vomiting; rash. Infants & childn 6 wk-5 yr: Fever (pyrexia); vaccination-site erythema or induration/swelling >2-7 cm (after toddler dose & in older childn 2 to <5 yr). Fever ≥38.9°C; vaccination-site erythema or induration/swelling >2-7 cm after infant series. Adults, childn & adolescents 5 to <18 yr: Headache; fatigue. Muscle & joint pain.
Drug Interactions
Administer different inj vaccines at different vaccination sites. Do not mix w/ other vaccines or medicinal 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
Prevnar 20 susp for inj 51 mcg/0.5 mL
Packing/Price
1's
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