Vaxneuvance

Vaxneuvance

vaccine, pneumococcal

Manufacturer:

Merck Sharp & Dohme

Distributor:

Zuellig Pharma
Concise Prescribing Info
Contents
Pneumococcal 15-valent conjugate vaccine (adsorbed)
Indications/Uses
Active immunization for prevention of invasive disease, pneumonia & acute otitis media caused by Strep pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F & 33F in adults ≥18 yr, infants, childn & adolescents from 6 wk to <18 yr.
Dosage/Direction for Use
IM Adult ≥18 yr 1 dose (0.5 mL). Catch-up vaccination schedule: 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 previous pneumococcal conjugate vaccine was administered. Unvaccinated childn 12 mth to <2 yr 2 doses (0.5 mL each) w/ 2 mth interval between doses. Unvaccinated infant 7 to <12 mth 3 doses (0.5 mL each). Administer 1st 2 doses at least 4 wk apart then 3rd (booster) dose after 12 mth, separated from 2nd dose by at least 2 mth. Routine vaccination schedule: Infant & childn 6 wk to <2 yr 2-dose primary series followed by booster dose 3 doses (0.5 mL each). Administer 1st dose as early as 6 wk followed by 2nd dose 8 wk later then 3rd (booster) dose between 11-15 mth. 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 wk w/ 4-8 wk interval between doses then 4th (booster) dose between 11-15 mth & at least 2 mth after 3rd dose. Preterm infant <37 wk gestation at birth Recommended immunisation regimen: 3-dose primary series followed by 4th (booster) dose.
Contraindications
History of severe allergic reaction to any component of vaccine or diphtheria toxoid-containing vaccine.
Special Precautions
Not to be inj intravascularly & in gluteal area or areas w/ major nerve trunk &/or blood vessel. Reduced immune response in patients w/ altered immunocompetence including those receiving immunosuppressive therapy. Not to be diluted or mixed w/ other vaccines. Pregnancy & lactation. Childn <6 wk. Potential risk of apnea in premature infants.
Adverse Reactions
Local reactions: Pain, erythema, swelling, induration. Systemic reactions: Decreased appetite, irritability, somnolence, urticaria, elevated body temp. Adults ≥18 yr, childn & adolescents 2-17 yr: Fatigue, headache, myalgia. Adults ≥18 yr: Arthralgia.
Drug Interactions
Reduced immune responses w/ immunosuppressive therapies eg, irradiation, antimetabolites, alkylating agents, cytotoxic drugs, corticosteroids, therapeutic proteins & targeted immunomodulators.
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 (pre-filled syringe) 0.5 mL
Packing/Price
10 × 1's;1's
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