Australian Doctor Australian Doctor 7th September 2018 | Page 11

• Includes 4 antigens which help achieve broad coverage 6
• Real world experience – including immunisation programs for infants 7 , 8
• Flexible dosing options that fit with routine vaccination visits 5
• Prophylactic paracetamol is recommended when BEXSERO is given to children < 2 years of age , regardless of the presence of fever 4
• In infants and toddlers , the most common adverse reactions were tenderness and erythema at the injection site , fever and irritability 5

TELL PARENTS ABOUT MENINGOCOCCAL B AND HOW BEXSERO CAN HELP PROTECT THEIR VULNERABLE INFANTS * 5

* Indicated from 2 months of age . 5
Multicomponent Meningococcal group B vaccine ( recombinant , adsorbed )

The only meningococcal B vaccine indicated from 2 months of age , offering the broadest age indication to help protect those most at risk . 5

• Includes 4 antigens which help achieve broad coverage 6
• Real world experience – including immunisation programs for infants 7 , 8
• Flexible dosing options that fit with routine vaccination visits 5
• Prophylactic paracetamol is recommended when BEXSERO is given to children < 2 years of age , regardless of the presence of fever 4
• In infants and toddlers , the most common adverse reactions were tenderness and erythema at the injection site , fever and irritability 5
PBS Information : This product is not listed on the National Immunisation Program ( NIP ). This product is not listed on the PBS .
Please review BEXSERO Product Information before prescribing . Full Product Information is available at au . gsk . com
Bexsero ® Minimum Product Information Multicomponent Meningococcal group B vaccine ( recombinant , adsorbed ). Indications : Active immunisation against invasive disease caused by N . meningitidis group B from 2 months of age . Contraindications : Hypersensitivity to any vaccine component . Precautions : Bexsero should never be administered intravenously , subcutaneously or intradermally . Postpone vaccination during acute severe febrile illness . Apnoea in very premature infants . Anticipate psychogenic response ( syncope , hyperventilation ). Anticipate fever ( prophylactic paracetamol ). Immune response may be reduced in immunocompromised Individuals . No data for use in subjects aged ≥50 years . Limited data in patients with chronic medical conditions . Kanamycin-sensitive individuals . Pregnancy ( category B1 ). Lactation . Safe use in latex sensitive individuals not established . Interactions : Can be given with DTPa , Hib , IPV , HepB , PCV7 , MenC-CRM , MMR and V . Immunogenicity of Bexsero or routine vaccines is unaffected by prophylactic paracetamol . Bexsero must be administered at separate injection sites . Adverse reactions : Infants , Toddlers & Children ( up to 10 years ): eating disorders , sleepiness , unusual crying , diarrhoea , vomiting , rash , fever ( ≥39.5 ° C ), injection site reactions , irritability . Adolescents ( from 11 years ) & Adults : headache , nausea , injection site reactions , malaise , myalagia , arthralgia . This is not a full list . Dosage and Administration : Administered by deep intramuscular injection . 0.5ml dose in a pre-filled syringe . Infants ( 2 – 5 months ): 3 doses ( ≥1 month interval ), booster dose at 12 – 23 months . Unvaccinated infants ( 6 – 11 months ): 2 doses ( ≥2 month interval ), booster dose at 12 – 23 months ( ≥2 month interval between primary series and booster ). Unvaccinated toddlers and children ( 12 months – 10 years ): 2 doses ( ≥2 month interval ), need for booster not established . 11 – 50 years : 2 doses ( ≥1 month interval ), need for booster not established . Storage : Between + 2 ° C and 8 ° C . DO NOT FREEZE . Protect from light . For further information , please refer to the full PI . [ Bexsero min PI v03 ]. References : 1 . Face to face market research conducted by IMS ; Sept 2016 N = 20 Australian mothers with a child between the age of 6 weeks and < 1 year . Purpose : To identify awareness , information sources of vaccination and decision-making factors . Data on file : AUS / BEX / 0051 / 16 . 2 . Online market research conducted by IPSOS South Australian Meningococcal Disease Awareness Campaign Survey February 2018 , N = 865 participants from the general population and parents of children aged 0-17 years . Data on file AUS / VAC / 0009 / 18 . 3 . Australian Government Department of Health . Invasive meningococcal disease national surveillance report . Available from : http :// www . health . gov . au / internet / main / publishing . nsf / content / cda-pubs-annlrpt-menganrep . htm Accessed on : 17.07.18 . 4 . Australian Technical Advisory Group on Immunisation ( ATAGI ). The Australian Immunisation Handbook 10th ed ( 2017 update ). Canberra : Australian Government Department of Health , 2017 . 5 . Bexsero Approved Product Information . 6 . Vesikan T et al . Lancet 2013 ; 381 : 825 – 35 . 7 . Meningococcal B . National Immunisation Office website . https :// www . hse . ie / eng / health / immunisation / hcpinfo / othervaccines / meningococcalb /. Accessed 3 May 2018 . 8 . Piano Nazionale Prevenzione Vaccinale PNPV 2017 – 2019 . Ministero della salute website . http :// www . salute . gov . it / imgs / C _ 17 _ pubblicazioni _ 2571 _ allegato . pdf . Accessed 3 May 2018 . For information on GSK products or to report an adverse event involving a GSK product , please contact GSK Medical Information on 1800 033 109 . GlaxoSmithKline Australia Pty Ltd . ABN 47 100 162 481 . Melbourne , VIC . Trade marks are owned by or licensed to the GSK group of companies © 2018 GSK group of companies or its licensor . AUS / BEX / 0031 / 18a . Date of approval August 2018 . BEX0105 .