Prevenar 13

Pneumococcal conjugate vaccine 13-valent (adsorbed)

Active immunization for the prevention of invasive disease, pneumonia & otitis media caused by Strep pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F & 23F in infants, childn & adolescents; pneumococcal disease (including pneumonia & invasive disease) caused by Strep pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F & 23F in adults ≥18 yr.

IM 0.5 mL. Adult ≥18 yr (including those previously vaccinated w/ pneumococcal polysaccharide vaccine) Administer as single dose. Childn 24 mth-17 yr Single dose. If previously vaccinated w/ ≥1 dose of pneumococcal 7-valent conjugate vaccine, then at least 8 wk should elapse before vaccination. Childn 24-71 mth who received any incomplete schedule of pneumococcal conjugate vaccine, 13-valent (adsorbed) Single dose separated from previous dose by at least 2 mth. Childn 12-23 mth w/ incomplete pneumococcal conjugate vaccine, 13-valent (adsorbed) who received 1 dose <12 mth 2 doses at least 2 mth apart & separated from 1st dose by at least 2 mth, 2 or 3 doses, 2 or 3 doses <12 mth Single dose separated from previous dose by at least 2 mth. Childn 15 mth-5 yr previously vaccinated w/ pneumococcal 7-valent conjugate vaccine Single dose at least 8 wk after final dose of pneumococcal-7 vaccine. Childn 15-23 mth who received single dose of pneumococcal 7-valent conjugate vaccine before 12 mth 2 doses of pneumococcal vaccine, 13-valent 2 doses of pneumococcal 13-valent at least 2 mth apart & separated from 1st dose by at least 2 mth. Infant & toddler Vaccination schedule: 1st dose at 2 mth (dose may be given as early as 6 wk); 2nd dose at 4 mth & 3rd dose at 6 mth (dosing interval of 4-8 wk); 4th dose at approx 12-15 mth & at least 2 mth after 3rd dose. As part of routine infant immunization program 3-dose schedule: 1st dose at 2 mth, 2nd dose at 2 mth later & 3rd (booster) dose between 11-15 mth. Preterm infant (<37 wk gestation) 4-dose immunization series of 0.5 mL each. Primary infant series consist of 3 doses w/ 1st dose given as early as 6 wk at 2 mth w/ interval of at least 1 mth between doses; 4th (booster) dose given at approx 12 mth. Previously unvaccinated childn ≥7 mth-5 yr (prior to 6^th birthday) 7-11 mth at 1st dose: 3 doses w/ 2 doses at least 4 wk apart, 3rd dose after 1 yr birthday, separated from 2nd dose by at least 2 mth. 12-23 mth at 1st dose: 2 doses at least 2 mth apart. ≥24 mth-5 yr: Single dose. Patient w/ higher risk of pneumococcal infection (eg, sickle cell disease or HIV infection), including those previously vaccinated w/ ≥1 dose of 23-valent pneumococcal polysaccharide vaccine May receive at least 1 dose. Patient w/ hematopoietic stem cell transplant (HSCT) 4-dose immunization series of 0.5 mL each. Primary series consist of 3 doses w/ 1st dose given 3-6 mth after HSCT & w/ interval of at least 1 mth between doses; booster dose given at 6 mth after 3rd dose.

Hypersensitivity to pneumococcal conjugate vaccine 13-valent including diphtheria toxoid.

Not to be administered intravascularly; in the gluteal area. Postpone administration in patients suffering from acute severe febrile illness. Not for protection against other microorganisms causing invasive disease, pneumonia or otitis media. Patient w/ thrombocytopenia or any coagulation disorder, or those receiving anticoagulant therapy. Individuals in immunocompromised groups eg, malignancy or nephrotic syndrome. Concomitant use w/ combined diphtheria-tetanus-acellular pertussis hepatitis B, enhanced inactivated polio vaccine & H. influenza type B vaccine. May temporarily affect ability to drive or use machines. Pregnancy & lactation. Childn ≥24 mth w/ sickle cell disease, asplenia, HIV infection, chronic illness, or who are otherwise immunocompromised. Risk of apnea in premature infants; monitor for at least 48 hr after vaccination in very premature infants (≤30 wk gestation); not to withhold or delay vaccination. Infant & childn <6 wk.

Decreased appetite; diarrhea, vomiting, vomiting in adult 18-49 yr; fever; rash; any vaccination-site erythema, induration/swelling or pain/tenderness, vaccination-site erythema or induration/swelling 2.5-7 cm (after toddler dose & in older childn 2-5 yr), vaccination-site tenderness (including impaired movement). Infants & childn 6 wk-5 yr: Irritability; drowsiness; increased/decreased or restless sleep. Fever >39°C. Childn & adolescents 6-17 yr: Irritability; drowsiness/increased or restless/decreased sleep. Headache; urticaria or urticaria-like rash. Adults ≥18 yr: Headache; generalized new/aggravated joint or muscle pain. Vomiting (in adult >50 yr).

May reduce immune response w/ paracetamol in infants.

Vaccines, Antisera & Immunologicals

J07AL02 - pneumococcus, purified polysaccharides antigen conjugated ; Belongs to the class of pneumococcal bacterial vaccines.

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