Advertisement
Advertisement
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; 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 Individual ≥18 yr 1 dose (0.5 mL). Need for revaccination w/ subsequent dose has not been established. 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). Administer 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 w/ 1st dose administered 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 3rd dose. Special population 1 dose may be administered to individuals who have ≥1 underlying conditions predisposing them to an increased risk of pneumococcal disease (eg, individuals w/ sickle cell disease, HIV-infected individuals, or immunocompetent individuals 18-49 yr w/ risk factors for pneumococcal disease).
Contraindications
Hypersensitivity to any component of Vaxneuvance or to any diphtheria toxoid-containing vaccine.
Special Precautions
Will only protect against Strep pneumoniae serotypes included in the vaccine. Do not administer intravascularly. No available data for SC or intradermal administration. Appropriate medical treatment & supervision should always be readily available in case of a rare anaphylactic event following vaccination. Postpone vaccination in individuals suffering from acute severe febrile illness or acute infection. Administer w/ 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. 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
Different injectable vaccines should always be administered 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
Advertisement
Advertisement
Advertisement
Advertisement
Advertisement
Advertisement
Advertisement