nip vaccines material request form original v2...immunisation to reduce the risk of fever (high...

Please fill out your details on the form provided and email to GSK Vaccines Department:[email protected] or post to GlaxoSmithKline, PO box 18095 Melbourne 8003

PLEASE PRINT IN BLOCK LETTERS

GSK NIP Vaccines Material Request Form August 2020

Title: _________ Name: _______________________________________ Role: __________________________

Organisation: ______________________________________________________________________________

Address: _________________________________________________________________________________

Phone: __________________________ Email: __________________________________________________

All GSK Vaccines Product Information and Consumer Medicine Information are available from au.gsk.com

Please tick if you would like to be kept up to date with immunisation related information

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. Melbourne, VIC. Trade marks are owned or licensed to the GSK group of companies © 2020 GSK group of companies or its licensor PM-AU-VX-BROC-200001 Date of GSK Approval: August 2020.

ROTARIX DOSING WHEEL PM-AU-ROT-DSEC-190001

QTY _________________________

ROTARIX

A wheel used to help determine date range allowed for first and second dose of Rotarix, based on baby’s birth date.

A4 CHILDHOOD AND ADOLESCENT NIP VACCINES

CARD AUS/VAB/0008/18(1)

QTY STICKER ___________________

QTY CARD ___________________

NATIONAL IMMUNISATION PROGRAM

A table of all GSK vaccines currently listed on the NIP. A quick reference guide on storage, administration and indication. Also available as a sticker.

A4 NIP VACCINE SUMMARY CARD

AUS/VAB/0008/18A

QTY STICKER ___________________

QTY CARD ___________________


A quick reference guide of all GSK NIP vaccines containing vaccine specific information such as reconstitution.

Also available as a sticker.

NIP LANDSCAPE CARD SETPM-AU-AVX-CRD-190001

QTY _________________________


A set of 8 small 7cm x 15cm cards for GSK NIP vaccines with vaccine specific information and a packshot. A space is provided on top to clip

on to a basket.

STOCK ROTATION STICKER NP-AU-GVX-STKR-200001

QTY _________________________


A small 10cm x 4cm sticker to act as a reminder to rotate stock and assist in

minimising vaccine wastage.

BEXSERO CLINICAL INFORMATION

BOOKLET (FOR HCPS)

PM-AU-BEX-LBND-200003

QTY _______________________

BEXSERO (NIP)

This clinical resource is designed for useby Healthcare Professionals as a

reference tool that outlines eligibilitycriteria, dosing schedules, administration

and paracetamol usage for MeningococcalB vaccine (Bexsero) in relation to the

populations listed on the NIP.

NIP FRIDGE STICKER SETPM-AU-AVX-CRD-190002

QTY _________________________


A set of 7 stickers, sized 7cm x 15cm for GSK NIP vaccines with specific

information and packshots.

GlaxoSmithKline Australia Pty Ltd. ABN 47 100 162 481. Melbourne VIC. NP-AU-GVX-STKR-200001 Date of Approval: July 2020

For more information on vaccine management please refer to the Strive for Five guidelines

so that the vaccines with the shortestexpiry date are used first

https://www.health.gov.au/resources/publications/national-vaccine-storage-guidelines-strive-for-5









Please review Bexsero Product Information before prescribing Full Product Information is available at au.gsk.com

BEXSERO Multicomponent Meningococcal group B vaccine (recombinant, adsorbed)

PBS Information: This product is listed on the National Immunisation Program (NIP) for Aboriginal and Torres Strait Islander children aged <2 years and for people of all ages with some medical risk conditions.

Refer to NIP schedule or your State or Territory Health department.

Indications: Active immunisation against invasive disease caused by N. meningitidis group B strains from 2 months of age. Dosage and Administration: Administered by deep intramuscular injection. Bexsero must not be injected intravenously, subcutaneously or intradermally. 0.5ml dose in a pre-filled syringe. Infants (2-5 months): 2 doses ( 2 months interval) OR 3 doses (≥1 month interval), a booster dose is recommended in the second year of life from 12 months of age ( 6 months after primary series). The safety and efficacy of Bexsero in infants less than 8 weeks of age has not yet been established. No data are available. Infants (6-11 months): 2 doses ( 2 months interval), booster dose in second year of life (≥2 months after primary series). Toddlers (12-23 months): 2 doses ( 2 months interval), need for booster not established. Children, adolescents and adults (2-50 years): 2 doses ( 1 month interval), need for booster not established. Contraindications: Hypersensitivity to any vaccine component. Special warnings and precautions: Postpone vaccination during acute severe febrile illness. Ensure appropriate medical treatment and supervision available in case of anaphylactic event. Apnoea in very premature infants. Anticipate anxiety-related reactions (syncope, hyperventilation). Anticipate fever (prophylactic paracetamol). Immune response may be reduced in immunocompromised Individuals. Those on treatment that inhibits terminal complement activation (e.g. eculizumab) remain at risk. No data for use in subjects aged 50 years. Limited data in patients with chronic medical conditions. Safe use in kanamycin-sensitive or 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. When given concomitantly with other vaccines Bexsero must be administered at separate injection sites. Pregnancy (category B1). Lactation safety information not available. Adverse reactions: Infants, Toddlers & Children (up to 10 years): very common - eating disorders, sleepiness, unusual crying, headache, diarrhoea, vomiting, rash, fever ( 38°C), injection site reactions, irritability and arthralgia. Adolescents (from 11 years) & Adults: very common - headache, nausea, injection site reactions, malaise, myalgia and arthralgia. This is not a full list. Storage: Between +2oC and 8oC. DO NOT FREEZE. Protect from light. For further information, please refer to the full PI. [Bexsero min PI v6]

References: 1. Australian Government Department of Health. National Immunisation Program – Meningococcal vaccination schedule from 1 July 2020 – Clinical advice for vaccination providers https://www.health.gov.au/resources/publications/national-immunisation-program-meningococcal-vaccination-schedule-from-1-july-2020-clinical-advice-for-vaccination-providers (accessed June 2020). 2. Australian Technical Advisory Group on Immunisation (ATAGI). The Australian immunisation handbook 10th ed (2017 update). Canberra: Australian Government Department of Health, 2018 https://immunisationhandbook.govcms.gov.au/ (accessed June 2020). 3. GSK Bexsero Approved Product Information.

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 ©2020 GSK group of companies or its licensor. Date of GSK Approval July 2020. PM-AU-BEX-LBND-200003.

Meningococcal B National Immunisation Programfor Aboriginal and Torres Strait Islander Infants and People with Some Medical Conditions.FROM 1 JULY 2020: BEXSERO (Meningococcal group B vaccine) is added to the National Immunisation Program for prevention of Meningococcal B disease in the following groups:1

BEXSERO (Meningococcal group B vaccine)3

Presentation

Shelf life

Storage

For more information, please go to Australian Government Department of Health, National Immunisation Program – Meningococcal vaccination schedule from 1 July 2020 – Clinical advice for vaccination providers.1

For information on other groups who remain strongly recommended for vaccination against meningococcal B disease, but are not funded through the NIP, refer to the Australian Immunisation Handbook.2

SCHEDULE FOR PEOPLE OF ALL AGES with some medical conditions that increase their risk of (IMD), see below:

Medical conditions Dose Schedule

•

•

•

Table 1: Aboriginal and Torres Strait Islander children < 2 years of age

Table 2: People with medical conditions that increase their risk of Invasive Meningococcal Disease (IMD)

IMMUNISATION SCHEDULE for Aboriginal and Torres Strait Islander children from 2 months of age

Number of doses Dose schedule

CATCH-UP VACCINATION for Aboriginal and Torres Strait Islander children < 2 years

Dose Schedule

.

IMPORTANT THINGS TO KNOW ABOUT BEXERSO

A4 TEAR-OFF PAD

NP-AU-MNX-PINF-200003

QTY PADS _______________________

BEXSERO (NIP)

An A4 sized tear-off pad (20 pages per pad) that provides important information for parents and carers of Aboriginal and

Torres Strait Islander children and is to be handed out by Healthcare Professionals

following the prescription of Bexsero.

IMPORTANT THINGS TO KNOW ABOUT BEXSERO (Meningococcal B vaccine)To be handed out by Healthcare Providers (for example your doctor, nurse or immunisation provider) following the decision to prescribe Bexsero to Aboriginal and Torres Strait Islander children as part of the National Immunisation Program (NIP)

Please read this leaflet carefully and also read the Consumer Medicines Information (CMI) for Bexsero, if you would like more information.1

What is Meningococcal B (Men B) disease?

Meningococcal disease is a rare but serious infection that can lead to serious complications.

There are different types of meningococcal disease and Men B is the most common type in young children compared with other age groups.2

Aboriginal and Torres Strait Islander children are at higher risk of getting meningococcal disease than non-Indigenous children.3

Men B infections are about 4 times higher in Aboriginal and Torres Strait Islander children under 2 years of age than in non-Indigenous children.2

What is Bexsero?

Bexsero is a vaccine that has been given to your child to help protect against Meningococcal B disease.

How is Bexsero given?

Bexsero is given as an injection by your healthcare provider, usually into the child’s arm or leg, like other vaccines.

What to do if your child is under 2 years of age?

To reduce the risk of fever (high temperature), children under the age of 2 should be given paracetamol 30 minutes before each dose of Bexsero (or as soon as possible after the dose is given).

After that, the child should receive another 2 doses of paracetamol, every 6 hours until three doses are given. This is to reduce the risk of your child experiencing a temperature (high fever).

If you have any questions or concerns about a fever (high temperature), please speak to your healthcare provider.

Bexsero is a vaccine that helps to protect against the B strain of meningococcal disease. Your child will need more than one dose of Meningococcal B vaccine (Bexsero). Please follow the advice from your healthcare provider about follow up appointments for further doses of Bexsero.

Paracetamol is given to all children under the age of 2 years who receive Bexsero. It is given in doses before and after immunisation to reduce the risk of fever (high temperature) following the immunisation. Please follow the instructions provided by your healthcare provider about the use of paracetamol and ask your nurse, doctor or Aboriginal Healthcare Worker if you have any questions about this information.

Your next appointment

Your child’s paracetamol dosing schedule

Dose 1 taken at

Dose 2 to be taken at

Dose 3 to be taken at

In order for the vaccine to work effectively, it is very important that your child receives the full number of doses recommended by your healthcare provider.

The number of doses needed and when they should be given depends on your child’s age.

Your healthcare provider will tell you how many doses your child might need and when to come back for your next dose.

How many doses of Bexsero are given?

?

We, GlaxoSmithKline Australia Pty Ltd ABN 47 100 162 481 collect, use and disclose personal information about you so we can perform our business activities and functions. We collect your personal information in order to administer medical education programs/management programs or other similar programs organised by us, send you material on and contact you regarding our activities and products. If we do not collect your personal information we may be unable to provide you with all of our services, for example information regarding our programs, events, services or products which may be of benefit to you. We will only disclose your personal information as necessary to third parties that we use in the ordinary operation of our business, such as for conference organising, marketing, data processing and associated printing and mailing. We will not disclose your personal information overseas. Our privacy policy can be found at http://www.gsk.com.au/privacy.aspx and contains information about how you may access and correct personal information held by us and how you can complain about a breach of privacy and how we will deal with such a complaint.

nip vaccines material request form original v2...immunisation to reduce the risk of fever (high...

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