Prevenar 13

Prevenar 13

vaccine, pneumococcal

Manufacturer:

Pfizer

Distributor:

Zuellig Pharma
Concise Prescribing Info
Contents
Pneumococcal polysaccharide conjugate vaccine (13-valent, adsorbed)
Indications/Uses
Adult ≥50 yr: Active immunisation for the prevention of pneumonia & invasive disease caused by Strep pneumoniae. Adult 18-49 yr: Active immunisation for the prevention of invasive disease & pneumonia caused by Strep pneumoniae. Infant 6 wk to 17 yr: Active immunisation for the prevention of invasive disease, pneumonia & acute otitis media caused by Strep pneumoniae.
Dosage/Direction for Use
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. Infant & childn 12-23 mth 2 doses w/ at least 2-mth interval between doses. Infant 7-11 mth 2 doses w/ at least 1-mth interval between doses; 3rd dose by 2nd yr. Infant 6 wk-6 mth Primary infant series consisting 3 doses w/ 1st dose given at 2 mth; can be given as young as 6 wk w/ at least 1-mth interval between doses, followed by a 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; can be given as young as 6 wk w/ at least 1-mth interval between doses; followed by a 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 the 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 At least 1 dose. Individual w/ hematopoietic stem cell transplant (HSCT) Primary series consisting 3 doses w/ the 1st dose given 3-6 mth after HSCT & w/ an interval of at least 1 mth between doses. Booster dose: 6 mth after the 3rd dose.
Contraindications
Hypersensitivity to pneumococcal polysaccharide conjugate vaccine or to diphtheria toxoid. Postpone administration in patients w/ acute, severe febrile illness.
Special Precautions
Do not administer intravascularly or inj intradermally, SC or IV, or in the gluteal area. Different injectable vaccines should be given at different vaccination sites. Patients w/ thrombocytopenia or any coagulation disorder, or to those receiving anticoagulants; impaired immune responsiveness; malignancy, nephrotic syndrome. May not protect all individuals receiving the vaccine from pneumococcal disease. Childn ≥2 yr w/ sickle cell disease, asplenia, HIV infection, chronic illness, or those who are immunocompromised. Consider the potential risk of apnoea & the need of resp monitoring for 48-72 hr when administering primary immunisation to very premature infants (≤28 wk of gestation) & particularly those w/ history of resp immaturity. Concomitant use w/ DTPa-HBV-IPV/Hib vaccine. Initiate antipyretic treatment to childn w/ seizure disorders or w/ history of febrile seizures & for all childn receiving concomitant vaccine containing whole cell pertussis. May temporarily affect the ability to drive or operate machinery. Pregnancy & lactation. Childn <6 wk.
Adverse Reactions
Decreased appetite; fever, vaccination-site erythema, induration/swelling or pain/tenderness. Irritability; drowsiness/increased sleep, restless/decreased sleep. Headache; diarrhea, vomiting (in adults 18-49 yr); rash; generalized new/aggravated joint & muscle pain; chills, fatigue, limitation of arm movement (adults 18-39 yr). Urticaria or urticaria-like rash.
Drug Interactions
Childn 6 wk-5 yr & infant: May reduce the immune response w/ paracetamol.
MIMS Class
Vaccines, Antisera & Immunologicals
ATC Classification
J07AL02 - pneumococcus, purified polysaccharides antigen conjugated ; Belongs to the class of pneumococcal bacterial vaccines.
Presentation/Packing
Form
Prevenar 13 vaccine inj 0.5 mL
Packing/Price
1's
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