Prevenar 13

Pneumococcal polysaccharide conjugate vaccine (13-valent, adsorbed)

Active immunisation for prevention of pneumonia & invasive disease caused by Strep pneumoniae in adults ≥18 yr. Active immunisation for the prevention of invasive disease, pneumonia & acute otitis media caused by Strep pneumoniae in infants & childn 6 wk to 17 yr.

IM 0.5 mL (1 dose). Adult ≥18 yr (including those previously vaccinated w/ pneumococcal polysaccharide vaccine) & elderly Single dose. Unvaccinated childn 2-17 yr Single dose, 12-23 mth 2 doses w/ at least 2 mth interval between doses, 7-11 mth 2 doses w/ at least 1 mth interval between doses; 3rd dose by 2nd yr. Infant 6 wk to 6 mth Primary infant series consisting 3 doses w/ 1st dose given at 2 mth (may be given as early as 6 wk) & w/ at least 1 mth interval between doses followed by 4th (booster) dose to be administered at 12-15 mth. Pre-term infant <37 wk gestation Primary infant series consisting 3 doses w/ 1st dose given at 2 mth (may be given as early as 6 wk) & w/ at least 1 mth interval between doses followed by 4th (booster) dose recommended approx at 12 mth. Childn 5-17 yr previously vaccinated w/ ≥1 doses of pneumococcal 7-valent conjugate vaccine Single dose at least 8 wk after final dose. Childn 12-59 mth completely immunised w/ pneumococcal 7-valent conjugate vaccine Single dose at least 8 wk after final dose. Childn & infant who have started immunisation w/ pneumococcal 7-valent conjugate vaccine May switch to Prevenar 13 at any point in the schedule. Individual who may be at higher risk of pneumococcal infection including those previously vaccinated w/ ≥1 doses of 23-valent pneumococcal polysaccharide vaccine (PPSV23) May be given at least 1 dose. Individual w/ hematopoietic stem cell transplant (HSCT) Primary series consisting 3 doses w/ 1st dose given 3-6 mth after HSCT & w/ interval of at least 1 mth between doses. Booster dose: 6 mth after 3rd dose.

Hypersensitivity to pneumococcal polysaccharide conjugate vaccine or diphtheria toxoid. Postpone vaccination in subjects suffering from acute severe febrile illness.

Appropriate medical treatment & supervision must be ready in case of rare anaphylactic event following vaccination. Do not administer intravascularly, intradermally, SC, IV, or in the gluteal area. Infants, child or adults w/ thrombocytopenia or any coagulation disorder, or those receiving anticoagulants. May not protect all individuals receiving vaccine from pneumococcal disease. Individuals w/ impaired immune responsiveness; immunocompromised groups (eg, those w/ malignancy or nephrotic syndrome). Concomitant use w/ DTPa-HBV-IPV/Hib vaccine. May temporarily affect ability to drive or use machines. Pregnancy & lactation. Initiate antipyretic treatment to childn w/ seizure disorders or w/ history of febrile seizures & for all childn receiving concomitant vaccine containing whole cell pertussis. Not to replace use of PPSV23 in childn ≥2 yr w/ conditions (eg, sickle cell disease, asplenia, HIV, chronic illness or those who are immunocompromised). Consider potential risk of apnea & need of resp monitoring for 48-72 hr when administering primary immunisation series to very premature infants (≤30 wk of gestation) & particularly those w/ history of resp immaturity. Childn <6 wk.

Decreased appetite; fever, vaccination-site erythema, induration/swelling or pain/tenderness. Diarrhea, vomiting, rash. Adult ≥18 yr & elderly: Headache; generalized new/aggravated joint & muscle pain; chills, fatigue, limitation of arm movement. Adolescent, child & infant (6 wk to 17 yr): Irritability; drowsiness/increased sleep, restless/decreased sleep. Urticaria or urticaria-like rash.

Different inj vaccines should be given at different vaccination sites. Childn 6 wk to 5 yr & infant: May reduce immune response w/ paracetamol.

Vaccines, Antisera & Immunologicals

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

POM