Vaxneuvance

Vaxneuvance

vaccine, pneumococcal

Manufacturer:

MSD

Distributor:

Zuellig
Concise Prescribing Info
Contents
Pneumococcal polysaccharide conjugate vaccine (15-valent, adsorbed)
Indications/Uses
Active immunisation for the prevention of invasive disease & pneumonia caused by Strep pneumoniae in individuals ≥18 yr. 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.
Dosage/Direction for Use
IM 1 dose may be given to individuals who have ≥1 underlying conditions predisposing them to an increased risk of pneumococcal disease (eg, individuals w/ sickle cell disease, living w/ HIV infection, or immunocompetent individuals 18-49 yr w/ risk factors for pneumococcal disease). Individual ≥18 yr 1 dose (0.5 mL). No established need for revaccination w/ a subsequent dose. Unvaccinated or not fully vaccinated childn & adolescent 2 to <18 yr 1 dose (0.5 mL). At least 2 mth should elapse before administering Vaxneuvance if a previous pneumococcal conjugate vaccine was administered. Unvaccinated childn 12 mth to <2 yr 2 doses (0.5 mL each) w/ an interval of 2 mth between doses. Unvaccinated infant 7 to <12 mth 3 doses (0.5 mL each). Administer 1st 2 doses at least 4 wk apart. Administer 3rd (booster) dose after 12 mth of age, separated from 2nd dose by at least 2 mth. Infant & childn 6 wk to <2 yr Infants & childn who have begun immunisation w/ another pneumococcal conjugate vaccine may switch to Vaxneuvance at any point in the schedule. In preterm infants (<37 wk gestation at birth), the recommended immunisation regimen consists of a 3-dose primary series followed by a 4th (booster) dose. 2-dose primary series followed by booster dose 3 doses (0.5 mL each). Primary series: Administer 1st dose as early as 6-12 wk of age, w/ 2nd dose administered 8 wk later. Booster dose: Administer 3rd dose between 11-15 mth of age. 3-dose primary series followed by booster dose 4 doses (0.5 mL each). Primary series: 3 doses. Administer 1st dose as early as 6-12 wk of age, w/ an interval of 4-8 wk between doses. Booster dose: Administer 4th dose between 11-15 mth of age & at least 2 mth after the 3rd dose.
Contraindications
Hypersensitivity to any component of the vaccine, or to any diphtheria toxoid-containing vaccine.
Special Precautions
Do not administer intravascularly. No available data for SC or intradermal routes. Appropriate medical treatment & supervision should always be readily available in case of rare anaphylactic event following vaccination. Postpone vaccination in individuals suffering from acute severe febrile illness or acute infection. Caution to individuals receiving anticoagulant therapy, or to those w/ thrombocytopenia or any coagulation disorder eg, haemophilia. Consider potential risk of apnoea & the need for resp monitoring for 48-72 hr when administering the primary immunisation series to very premature infants (born ≤28 wk of gestation) & particularly for those w/ previous history of resp immaturity. Immunocompromised individuals may have reduced Ab response to active immunisation. May not protect all vaccine recipients. Consider administration during pregnancy only when potential benefits outweigh any potential risks for the mother & foetus. Unknown whether excreted in human milk.
Adverse Reactions
Inj site pain/swelling/erythema. Adult ≥18 yr: Fatigue, myalgia, headache, arthralgia. Childn & adolescent 2 to <18 yr: Myalgia, fatigue, headache, inj site induration, pyrexia ≥38°C. Infant & childn 6 wk to <2 yr: Pyrexia ≥38°C, irritability, somnolence, decreased appetite, inj site induration.
Drug Interactions
Always administer different injectable vaccines at different inj sites. Immunosuppressive therapies may reduce immune responses to vaccines.
MIMS Class
Vaccines, Antisera & Immunologicals
ATC Classification
J07AL02 - pneumococcus, purified polysaccharides antigen conjugated ; Belongs to the class of pneumococcal bacterial vaccines.
Presentation/Packing
Form
Vaxneuvance susp for inj 0.5 mL
Packing/Price
1's
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