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Bexsero

Bexsero

vaccine, meningococcal

Manufacturer:

GlaxoSmithKline Vaccines

Distributor:

GlaxoSmithKline
Concise Prescribing Info
Contents
Meningococcal group B vaccine (rDNA, component, adsorbed)
Indications/Uses
Active immunisation of individuals ≥2 mth of age against invasive meningococcal disease caused by Neisseria meningitidis group B.
Dosage/Direction for Use
IM Adult, adolescent ≥11 yr & childn 2-10 yr Primary immunisation: 2 doses (0.5 mL/dose) w/ not less than 1 mth intervals between primary doses. Booster: Consider in individuals at continued risk of exposure. Childn 12-23 mth Primary immunisation: 2 doses w/ not less than 2 mth intervals between primary doses. Booster: 1 dose w/ 12-23 mth intervals between primary series & booster dose. Infant 6-11 mth Primary immunisation: 2 doses w/ not less than 2 mth intervals between primary doses. Booster: 1 dose in the 2nd yr of life w/ at least 2 mth interval between the primary series & booster dose. Infant 2-5 mth Primary immunisation: 3 doses w/ not less than 1 mth intervals between primary doses, or 2 doses w/ not less than 2 mth intervals between primary doses. Booster: 1 dose between 12 & 15 mth of age w/ at least 6 mth interval between the primary series & booster dose.
Contraindications
Special Precautions
Postpone administration in patients w/ acute severe febrile illness. Do not inj intravascularly, SC or intradermally. Appropriate medical treatment & supervision should always be readily available in case of an anaphylactic event following administration. May not protect all vaccine recipients. Not expected to provide protection against all circulating meningococcal group B strains. Should not be given to patients w/ thrombocytopenia or any coagulation disorders that would contraindicate IM inj unless potential benefit clearly outweighs the risk of administration. Temp elevation may occur following vaccination of infants & childn (<2 yr). Prophylactic administration of antipyretics at the time of & closely after vaccination can reduce the incidence & intensity of post-vaccination febrile reactions. Patients w/ impaired immune responsiveness may have reduced Ab response to active immunisation. Patients w/ complement deficiencies (eg, C3 or C5 deficiencies) & patients receiving treatment that inhibits terminal complement activation (eg, eculizumab) remain at increased risk of invasive disease caused by Neisseria meningitidis group B even following vaccination. Limited data in patients w/ chronic medical conditions. Potential risk of apnoea & the need for resp monitoring for 48-72 hr should be considered when administering primary immunisation series to very premature infants (born ≤28 wk of gestation), particularly for those w/ previous history of resp immaturity. Safe use in kanamycin-sensitive individuals has not been established. Pregnancy & lactation.
Adverse Reactions
Headache; arthralgia; inj site erythema, swelling & induration. Adults & adolescents ≥11 yr: Nausea; myalgia; inj site pain, malaise. Infants & childn ≤10 yr: Eating disorders; sleepiness, unusual crying; diarrhoea, vomiting (uncommon after booster); rash (childn 12-23 mth) (uncommon after booster); fever (≥38°C), inj site tenderness, irritability. Rash (infants & childn 2-10 yr).
Drug Interactions
More frequent occurrence of fever, tenderness at inj site, change in eating habits & irritability w/ monovalent or combination vaccines: diphtheria, tetanus, acellular pertussis, HIB, inactivated poliomyelitis, hepatitis B, heptavalent pneumococcal conjugate, MMR, varicella, & meningococcal groups A, C, W, Y conjugate. Concomitant administration w/ vaccines containing whole cell pertussis is not recommended.
MIMS Class
Vaccines, Antisera & Immunologicals
ATC Classification
J07AH09 - meningococcus B, multicomponent vaccine ; Belongs to the class of meningococcal bacterial vaccines.
Presentation/Packing
Form
Bexsero susp for inj 0.5 mL
Packing/Price
1's
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