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NOTES RECOGNITION AND TREATMENT OF ANAPHYLAXIS CONTACT DETAILS FOR AUSTRALIAN, STATE AND TERRITORY GOVERNMENT HEALTH AUTHORITIES Signs of anaphylaxis Anaphylaxis causes respiratory and/or cardiovascular signs or symptoms AND involves other organ systems, such as the skin or gastrointestinal tract, with: Australian Government health authorities • signs of airway obstruction, such as cough, wheeze, hoarseness, stridor or signs of respiratory distress (e.g. tachypnoea, cyanosis, rib recession) • upper airway swelling (lip, tongue, throat, uvula or larynx) • tachycardia, weak/absent carotid pulse • hypotension that is sustained and with no improvement without specific treatment (Note: in infants and young children limpness and pallor are signs of hypotension) • loss of consciousness with no improvement once supine or in head-down position • skin signs, such as pruritus (itchiness), generalised erythema (redness), urticaria (weals) or angioedema (localised or general swelling of the deeper layers of the skin or subcutaneous tissue) • abdominal cramps, diarrhoea, nausea and/or vomiting • sense of severe anxiety and distress. Australian Government Department of Health and Ageing www.health.gov.au All information in this publication is correct as at November 2012 <1 year (approx. 5–10 kg) 0.05–0.1 mL 7–10 years (approx. 30 kg) 0.3 mL 1–2 years (approx. 10 kg) 0.1 mL 10–12 years (approx. 40 kg) 0.4 mL 2–3 years (approx. 15 kg) 0.15 mL >12 years and adult (over 50 kg) 0.5 mL 4–6 years (approx. 20 kg) 0.2 mL For more detailed information, see 2.3.2 Adverse events following immunisation. * Modified from The Brighton Collaboration Case Definition Criteria for Anaphylaxis, and an insert published in Australian Prescriber in August 2011 (available at www.australianprescriber.com/magazine/34/4/article/1210.pdf). D0903 February 2013 Doses of 1:1000 (one in one thousand) adrenaline: (to connect to your local Public Health Unit) Northern Territory 08 8922 8044 Centre for Disease Control Queensland 13 HEALTH (13 4325 84) Contact your local Public Health Unit, details at www.health.qld.gov.au/cdcg/contacts.asp South Australia 1300 232 272 (8.30 am to 5.00 pm) Email: [email protected] O N The following table lists the doses of 1:1000 adrenaline to be used if the exact weight of the person is not known (based on the person’s age). 1300 066 055 www.sahealth.sa.gov.au Tasmania 03 6222 7666 or 1800 671 738 Victoria 1300 882 008 Email: [email protected] www.health.vic.gov.au/immunisation Western Australia 08 9388 4868 08 9328 0553 (after hours Infectious Diseases Emergency) Email: [email protected] i The use of 1:1000 adrenaline is recommended because it is universally available. Adrenaline 1:1000 contains 1 mg of adrenaline per mL of solution in a 1 mL glass vial. Use a 1 mL syringe to improve the accuracy of measurement when drawing up small doses. 10th Edition 2013 S A T The recommended dose of 1:1000 adrenaline is 0.01 mL/kg body weight (equivalent to 0.01 mg/kg), up to a maximum of 0.5 mL or 0.5 mg, given by deep intramuscular injection into the anterolateral thigh. Adrenaline 1:1000 must not be administered intravenously. The Australian Immunisation Handbook 02 6205 2300 Immunisation Enquiry Line New South Wales i Adrenaline dosage State and territory government health authorities Australian Capital Territory M M U N Antihistamines and/or hydrocortisone are not recommended for the emergency management of anaphylaxis. Freecall: 1800 671 811 www.immunise.health.gov.au i • If the patient is unconscious, lie him/her on the left side and position to keep the airway clear. If the patient is conscious, lie supine in ‘head-down and feet-up’ position (unless this results in breathing difficulties). • Give adrenaline by intramuscular injection (see below for dosage) if there are any signs of anaphylaxis with respiratory and/or cardiovascular symptoms or signs. Although adrenaline is not required for generalised non-anaphylactic reactions (such as skin rash without other signs or symptoms), administration of intramuscular adrenaline is safe. • Call for assistance. Never leave the patient alone. • If oxygen is available, administer by facemask at a high flow rate. • If there is no improvement in the patient’s condition within 5 minutes, repeat doses of adrenaline every 5 minutes, until improvement occurs. • Check breathing; if absent, commence basic life support or appropriate cardiopulmonary resuscitation (CPR) as per the Australian Resuscitation Council guideline (www.resus.org.au/policy/guidelines). • Transfer all cases to hospital for further observation and treatment. • Complete full documentation of the event, including the time and dose(s) of adrenaline given. Experienced practitioners may choose to use an oral airway, if the appropriate size is available, but its use is not routinely recommended, unless the patient is unconscious. The Australian Immunisation Handbook – 10th Edition 2013 Management of anaphylaxis 02 6289 1555 For changes introduced in the 10th edition of the Handbook, see 1.4 What’s new NOTES RECOGNITION AND TREATMENT OF ANAPHYLAXIS CONTACT DETAILS FOR AUSTRALIAN, STATE AND TERRITORY GOVERNMENT HEALTH AUTHORITIES Signs of anaphylaxis Anaphylaxis causes respiratory and/or cardiovascular signs or symptoms AND involves other organ systems, such as the skin or gastrointestinal tract, with: Australian Government health authorities • signs of airway obstruction, such as cough, wheeze, hoarseness, stridor or signs of respiratory distress (e.g. tachypnoea, cyanosis, rib recession) • upper airway swelling (lip, tongue, throat, uvula or larynx) • tachycardia, weak/absent carotid pulse • hypotension that is sustained and with no improvement without specific treatment (Note: in infants and young children limpness and pallor are signs of hypotension) • loss of consciousness with no improvement once supine or in head-down position • skin signs, such as pruritus (itchiness), generalised erythema (redness), urticaria (weals) or angioedema (localised or general swelling of the deeper layers of the skin or subcutaneous tissue) • abdominal cramps, diarrhoea, nausea and/or vomiting • sense of severe anxiety and distress. Australian Government Department of Health and Ageing www.health.gov.au All information in this publication is correct as at November 2012 <1 year (approx. 5–10 kg) 0.05–0.1 mL 7–10 years (approx. 30 kg) 0.3 mL 1–2 years (approx. 10 kg) 0.1 mL 10–12 years (approx. 40 kg) 0.4 mL 2–3 years (approx. 15 kg) 0.15 mL >12 years and adult (over 50 kg) 0.5 mL 4–6 years (approx. 20 kg) 0.2 mL For more detailed information, see 2.3.2 Adverse events following immunisation. * Modified from The Brighton Collaboration Case Definition Criteria for Anaphylaxis, and an insert published in Australian Prescriber in August 2011 (available at www.australianprescriber.com/magazine/34/4/article/1210.pdf). D0903 February 2013 Doses of 1:1000 (one in one thousand) adrenaline: (to connect to your local Public Health Unit) Northern Territory 08 8922 8044 Centre for Disease Control Queensland 13 HEALTH (13 4325 84) Contact your local Public Health Unit, details at www.health.qld.gov.au/cdcg/contacts.asp South Australia 1300 232 272 (8.30 am to 5.00 pm) Email: [email protected] O N The following table lists the doses of 1:1000 adrenaline to be used if the exact weight of the person is not known (based on the person’s age). 1300 066 055 www.sahealth.sa.gov.au Tasmania 03 6222 7666 or 1800 671 738 Victoria 1300 882 008 Email: [email protected] www.health.vic.gov.au/immunisation Western Australia 08 9388 4868 08 9328 0553 (after hours Infectious Diseases Emergency) Email: [email protected] i The use of 1:1000 adrenaline is recommended because it is universally available. Adrenaline 1:1000 contains 1 mg of adrenaline per mL of solution in a 1 mL glass vial. Use a 1 mL syringe to improve the accuracy of measurement when drawing up small doses. 10th Edition 2013 S A T The recommended dose of 1:1000 adrenaline is 0.01 mL/kg body weight (equivalent to 0.01 mg/kg), up to a maximum of 0.5 mL or 0.5 mg, given by deep intramuscular injection into the anterolateral thigh. Adrenaline 1:1000 must not be administered intravenously. The Australian Immunisation Handbook 02 6205 2300 Immunisation Enquiry Line New South Wales i Adrenaline dosage State and territory government health authorities Australian Capital Territory M M U N Antihistamines and/or hydrocortisone are not recommended for the emergency management of anaphylaxis. Freecall: 1800 671 811 www.immunise.health.gov.au i • If the patient is unconscious, lie him/her on the left side and position to keep the airway clear. If the patient is conscious, lie supine in ‘head-down and feet-up’ position (unless this results in breathing difficulties). • Give adrenaline by intramuscular injection (see below for dosage) if there are any signs of anaphylaxis with respiratory and/or cardiovascular symptoms or signs. Although adrenaline is not required for generalised non-anaphylactic reactions (such as skin rash without other signs or symptoms), administration of intramuscular adrenaline is safe. • Call for assistance. Never leave the patient alone. • If oxygen is available, administer by facemask at a high flow rate. • If there is no improvement in the patient’s condition within 5 minutes, repeat doses of adrenaline every 5 minutes, until improvement occurs. • Check breathing; if absent, commence basic life support or appropriate cardiopulmonary resuscitation (CPR) as per the Australian Resuscitation Council guideline (www.resus.org.au/policy/guidelines). • Transfer all cases to hospital for further observation and treatment. • Complete full documentation of the event, including the time and dose(s) of adrenaline given. Experienced practitioners may choose to use an oral airway, if the appropriate size is available, but its use is not routinely recommended, unless the patient is unconscious. The Australian Immunisation Handbook – 10th Edition 2013 Management of anaphylaxis 02 6289 1555 For changes introduced in the 10th edition of the Handbook, see 1.4 What’s new • Localised pain, redness and swelling at injection site • Low-grade temperature (fever) • Mild headache • Mild nausea Human papillomavirus vaccine (HPV) • Localised pain, redness and swelling at injection site • Occasionally, an injection-site nodule; may last many weeks; no treatment needed • Low-grade temperature (fever) In children, the following may also occur: • Irritable, crying, unsettled and generally unhappy • Drowsiness or tiredness Diphtheria-tetanus-pertussis (acellular) DTPa-containing vaccines and dTpa (reduced antigen) vaccines • Drowsiness or tiredness • Muscle aches • Localised pain, redness and swelling at injection site • Occasionally, an injection-site nodule; may last many weeks; no treatment needed • Low-grade temperature (fever) Influenza vaccine • Localised pain, redness and swelling at injection site • Occasionally, an injection-site nodule; may last many weeks; no treatment needed • Low-grade temperature (fever) Haemophilus influenzae type b vaccine (Hib) • Occasionally, an injection-site nodule; may last many weeks; no treatment needed Seen 7–10 days after vaccination: • Temperature (fever, can be >39.4˚C), lasting 2–3 days, faint red rash (not infectious), head cold and/or runny nose, cough and/or puffy eyes • Drowsiness or tiredness • Swelling of salivary glands Measles-mumps-rubella vaccine (MMR, MMRV – see also varicella) • Localised pain, redness and swelling at injection site • Low-grade temperature (fever) Hepatitis A vaccine (HepA) Varicella vaccine (VV) • Irritable, crying, unsettled and generally unhappy • Loss of appetite • Headache (usually observed in adolescents/adults) • Localised pain, redness and swelling at injection site • Occasionally, an injection-site nodule; may last many weeks; no treatment needed • Low-grade temperature (fever) Meningococcal C conjugate vaccine (MenCCV) • Localised pain, redness and swelling at injection site • Occasionally, an injection-site nodule; may last many weeks; no treatment needed • Low-grade temperature (fever) Hepatitis B vaccine (HepB) EFFECT OF DISEASE Up to 1 in 7 patients die. The bacteria release a toxin, which can produce nerve paralysis and heart failure. At least 7 in 10 adult patients develop jaundice (yellowing of the skin and eyes), fever, anorexia (decreased appetite), nausea, vomiting, hepatic (liver) pain and malaise (tiredness). About 1 in 4 chronic carriers will develop cirrhosis or liver cancer. About 1 in 20 meningitis patients dies and about 1 in 4 survivors has permanent brain or nerve damage. Epiglottitis is rapidly and invariably fatal without treatment. About 7 in 10 cervical cancers worldwide have been associated with HPV-16 and 1 in 6 with HPV-18. There are an estimated 3000 deaths in people older than 50 years of age each year in Australia. Causes increased hospitalisation in the very young (under 5 years of age) and the elderly. Other high-risk groups include pregnant women, people who are obese, diabetics and others with certain chronic medical conditions. About 1 in 15 children with measles develops pneumonia and 1 in 1000 develops encephalitis (brain inflammation). For every 10 children who develop measles encephalitis, 1 dies and many have permanent brain damage. About 1 in 100 000 develops SSPE (brain degeneration), which is always fatal. About 1 in 10 patients dies. Of those that survive, 1 to 2 in 10 have permanent long-term problems, such as loss of limbs and brain damage. One in 5000 children develops encephalitis (brain inflammation). One in 5 males (adolescent/adult) develop inflammation of the testes. Occasionally, mumps causes infertility or permanent deafness. About 1 in 125 babies under the age of 6 months with whooping cough dies from pneumonia or brain damage. About 3 in 10 people with meningitis die. One-third of all pneumonia cases and up to half of pneumonia hospitalisations in adults is caused by pneumococcal infection. While many infections cause no symptoms, up to 3 in 10 patients with paralytic polio die, and many patients who survive are permanently paralysed. Illness may range from mild diarrhoea to severe dehydrating diarrhoea and fever, which can result in death. Of children under 5 years of age, before vaccine introduction, approximately 10 000 children were hospitalised, 115 000 needed GP visits and 22 000 required an Emergency Department visit each year in Australia. Patients typically develop a rash, painful swollen glands and painful joints. One in 3000 develops low platelet count (causing bruising or bleeding); 1 in 6000 develops encephalitis (brain inflammation). Up to 9 in 10 babies infected during the first trimester of pregnancy will have a major congenital abnormality (including deafness, blindness or heart defects). About 2 in 100 patients die. The risk is greatest for the very young or old. One in 100 000 patients develops encephalitis (brain inflammation). Infection during pregnancy can result in congenital malformations in the baby. Infection in the mother around delivery time results in severe infection in the newborn baby in up to one-third of cases. DISEASE Diphtheria – bacteria spread by respiratory droplets; causes severe throat and breathing difficulties. Hepatitis A – virus spread by contact or ingestion of faecally contaminated water/food or through contact with the faecal material of a person infected with hepatitis A. Hepatitis B – virus spread mainly by blood, sexual contact or from mother to newborn baby; causes acute hepatitis (liver infection) or chronic infection (‘carrier’). Hib – bacteria spread by respiratory droplets; causes meningitis (infection of the tissues surrounding the brain), epiglottitis (respiratory obstruction), septicaemia (infection of the blood stream) and septic arthritis (infection in the joints). Human papillomavirus – virus spread mainly via sexual contact; up to 80% of the population will be infected with HPV at some time in their lives. Some HPV types are associated with the development of cancer. Influenza – virus spread by respiratory droplets; causes fever, muscle and joint pains, pneumonia. About 1 in 10 to 1 in 5 persons will get influenza every year. Measles – highly infectious virus spread by respiratory droplets; causes fever, cough and rash. Meningococcal infection – bacteria spread by respiratory droplets; causes septicaemia (infection of the blood stream) and meningitis (infection of the tissues surrounding the brain). Mumps – virus spread by saliva; causes swollen neck and salivary glands, and fever. Pertussis – bacteria spread by respiratory droplets; causes ‘whooping cough’, with prolonged cough lasting up to 3 months. Pneumococcal infection – bacteria spread by respiratory droplets; causes septicaemia (infection of the blood stream), meningitis (infection of the tissues surrounding the brain) and occasionally other infections. Polio – virus spread in faeces and saliva; causes fever, headache and vomiting and may progress to paralysis. Rotavirus – virus spread by faecal–oral route; causes gastroenteritis, which can be severe. Rubella – virus spread by respiratory droplets; causes fever, rash and swollen glands, but causes severe malformations in babies of infected pregnant women. Tetanus – caused by toxin of bacteria in soil; causes painful muscle spasms, convulsions, lockjaw. Varicella (chickenpox) – highly contagious virus; causes low-grade fever and vesicular rash (fluid-filled spots). Reactivation of the virus later in life causes herpes zoster (shingles). About 1 in 5 has a local reaction or fever. About 3 to 5 in 100 may develop a mild varicella-like rash. Serious adverse events are very rare. About 1 in 10 has local swelling, redness or pain at the injection site, or fever (DTPa/dTpa vaccine). Booster doses of DTPa may occasionally be associated with extensive swelling of the limb, but this resolves completely within a few days. Serious adverse events are very rare. About 1 in 10 has local swelling, redness or pain at the injection site. About 1 in 20 has swollen glands, stiff neck or joint pains. About 1 in 20 has a rash, which is non-infectious. Low platelet count (causing bruising or bleeding) occurs after the1st dose of MMR vaccine, at a rate of about 1 in 20 000 to 30 000. Serious adverse events are very rare. Up to 3 in 100 may develop diarrhoea or vomiting in the week after receiving the vaccine. About 1 in 17 000 babies may develop intussusception in the first few weeks after the 1st or 2nd vaccine doses. Serious adverse events are very rare. Local redness, pain and swelling at the injection site are common. Up to 1 in 10 has fever, crying and decreased appetite. Serious adverse events are very rare. About 1 in 5 has local swelling, redness or pain at the injection site, or fever (conjugate vaccine). Up to 1 in 2 has local swelling, redness or pain at the injection site (polysaccharide vaccine). Serious adverse events are very rare. About 1 in 10 has local swelling, redness or pain at the injection site, or fever (DTPa/dTpa vaccine). Booster doses of DTPa may occasionally be associated with extensive swelling of the limb, but this resolves completely within a few days. Serious adverse events are very rare. About 1 in 100 may develop swelling of the salivary glands. Serious adverse events are very rare. About 1 in 10 has local swelling, redness or pain at the injection site, fever, irritability, loss of appetite or headaches (conjugate vaccines). About 1 in 2 has a local reaction (polysaccharide vaccine). Serious adverse events are very rare. About 1 in 10 has local swelling, redness or pain at the injection site, or fever. About 1 in 20 develops a rash, which is noninfectious. Low platelet count (causing bruising or bleeding) occurs after the 1st dose of MMR vaccine at a rate of about 1 in 20 000 to 30 000. Serious adverse events are very rare. About 1 in 10 has local swelling, redness or pain at the injection site. Fever occurs in about 1 in 10 children aged 6 months to 3 years. Guillain-Barré syndrome occurs in about 1 in 1 million. Serious adverse events are very rare. About 8 in 10 will have pain and 2 in 10 will have local swelling, redness or pain at the injection site. Headache, fever, muscle aches and tiredness may occur in up to 3 in 10 people. Serious adverse events are very rare. About 1 in 20 has local swelling, redness or pain at the injection site. About 1 in 50 has fever. Serious adverse events are very rare. About 1 in 20 will have local swelling, redness or pain at the injection site and 2 in 100 will have fever. Anaphylaxis occurs in about 1 in 1 million. Serious adverse events are very rare. About 1 in 5 will have local swelling, redness or pain at the injection site. Serious adverse events are very rare. About 1 in 10 has local swelling, redness or pain at the injection site, or fever (DTPa/dTpa vaccine). Booster doses of DTPa may occasionally be associated with extensive swelling of the limb, but this resolves completely within a few days. Serious adverse events are very rare. SIDE EFFECT OF VACCINE INFORMATION SHEET – COMPARISON OF THE EFFECTS OF DISEASES AND THE SIDE EFFECTS OF NIP VACCINES From The Australian Immunisation Handbook 10th Edition (see Handbook contents for more details) INFORMATION SHEET – ADVERSE EVENTS FOLLOWING IMMUNISATION Side effects following immunisation for vaccines used in the National Immunisation Program (NIP) schedule Common adverse events following immunisation are usually mild and temporary (occurring in the first few days after vaccination, unless otherwise stated). Specific treatment is not usually required (see below). If the adverse event following immunisation is unexpected, persistent and/or severe, or if you are worried about your or your child’s condition, see your doctor or immunisation nurse as soon as possible, or go directly to a hospital. Adverse events that occur following immunisation may be reported to the Therapeutic Goods Administration (TGA) (www.tga.gov.au) or to the Adverse Medicines Events line on 1300 134 237, or discuss with your immunisation provider as to how reports are submitted in your state or territory. Inactivated poliomyelitis vaccine (IPV) and IPV-containing vaccines Rotavirus vaccine Pneumococcal vaccines (conjugate 13vPCV and polysaccharide 23vPPV) • Muscle aches • Localised pain, redness and swelling at injection site • Occasionally, an injection-site nodule; may last many weeks; no treatment needed • Low-grade temperature (fever) • Vomiting and diarrhoea can occur up to 7 days following vaccination • Localised pain, redness and swelling at injection site • Occasionally, an injection-site nodule; may last many weeks; no treatment needed • Low-grade temperature (fever) • Localised pain, redness and swelling at injection site • Occasionally, an injection-site nodule; may last many weeks; no treatment needed • Temperature (fever, can be >39˚C) Seen 5–26 days after vaccination: • Pustular rash (2–5 lesions), usually at injection site, occasionally elsewhere Key to table meningococcal C conjugate vaccine measles-mumps-rubella vaccine measles-mumps-rubella-varicella vaccine pneumococcal conjugate vaccine (13 serotypes) pneumococcal polysaccharide vaccine (23 serotypes) rotavirus vaccine varicella vaccine Concerns MenCCV MMR MMRV 13vPCV 23vPPV Rotavirus VV Managing fever after immunisation diphtheria-tetanus-pertussis acellular (infant/child formulation) diphtheria-tetanus-pertussis acellular (reduced antigen content formulation) hepatitis A vaccine hepatitis B vaccine Haemophilus influenzae type b vaccine human papillomavirus vaccine influenza or flu vaccine inactivated poliomyelitis vaccine How to manage injection site discomfort If you are worried about yourself or your child’s condition after a vaccination, see your doctor or immunisation nurse as soon as possible, or go directly to a hospital. It is also important to seek medical advice if you or your child are unwell, as this may be due to other illness rather than because of the vaccination. DTPa dTpa HepA HepB Hib HPV Influenza IPV Many vaccine injections may result in soreness, redness, itching, swelling or burning at the injection site for 1 to 2 days. Paracetamol might be required to ease the discomfort. Sometimes a small, hard lump (nodule) at the injection site may persist for some weeks or months. This should not be of concern and requires no treatment. Give extra fluids to drink. Do not overdress the baby if hot. Although routine use of paracetamol after vaccination is not recommended, if fever is present, paracetamol can be given. The dose of paracetamol for a child up to 12 years of age is 15 mg/kg/dose, every 4 to 6 hours, up to four times a day. Adults and children aged ≥12 years can receive 500 to 1000 mg every 4 to 6 hours. Paracetamol should not be given for more than 48 hours without seeking medical advice. i Immunisation Handbook th Edition 2013 S A T th i 10 M M U N The Australian i O N Copyright The Australian Immunisation Handbook 10th edition 2013 ISBN: 978-1-74241-861-2 Online ISBN: 978-1-74241-862-9 Publications approval number: D0903 Copyright statements: Paper-based publications © Commonwealth of Australia 2013 This work is copyright. You may reproduce the whole or part of this work in unaltered form for your own personal use or, if you are part of an organisation, for internal use within your organisation, but only if you or your organisation do not use the reproduction for any commercial purpose and retain this copyright notice and all disclaimer notices as part of that reproduction. Apart from rights to use as permitted by the Copyright Act 1968 or allowed by this copyright notice, all other rights are reserved and you are not allowed to reproduce the whole or any part of this work in any way (electronic or otherwise) without first being given the specific written permission from the Commonwealth to do so. Requests and inquiries concerning reproduction and rights are to be sent to the Online, Services and External Relations Branch, Department of Health and Ageing, GPO Box 9848, Canberra ACT 2601, or via e-mail to [email protected]. Internet sites © Commonwealth of Australia 2013 This work is copyright. You may download, display, print and reproduce the whole or part of this work in unaltered form for your own personal use or, if you are part of an organisation, for internal use within your organisation, but only if you or your organisation do not use the reproduction for any commercial purpose and retain this copyright notice and all disclaimer notices as part of that reproduction. Apart from rights to use as permitted by the Copyright Act 1968 or allowed by this copyright notice, all other rights are reserved and you are not allowed to reproduce the whole or any part of this work in any way (electronic or otherwise) without first being given the specific written permission from the Commonwealth to do so. Requests and inquiries concerning reproduction and rights are to be sent to the Online, Services and External Relations Branch, Department of Health and Ageing, GPO Box 9848, Canberra ACT 2601, or via e-mail to [email protected]. These guidelines were approved by the Chief Executive Officer of the National Health and Medical Research Council (NHMRC) on 25/01/2013, under Section 14A of the National Health and Medical Research Council Act 1992. In approving these guidelines the NHMRC considers that they meet the NHMRC standard for clinical practice guidelines. This approval is valid for a period of five years. NHMRC is satisfied that they are based on the systematic identification and synthesis of the best available scientific evidence and make clear recommendations for health professionals practising in an Australian health care setting. The NHMRC expects that all guidelines will be reviewed no less than once every five years. This publication reflects the views of the authors and not necessarily the views of the Australian Government. ii The Australian Immunisation Handbook 10th edition FOREWORD Since 1932, when Government vaccination began for Australian children, illness and death from vaccine-preventable diseases have fallen greatly. Australia still has one of the world’s most comprehensive publicly funded immunisation programs. As a result, tetanus, diphtheria, Haemophilus influenzae type b, poliomyelitis, congenital rubella and newly acquired hepatitis B are no longer seen or are extremely rare. Immunisation is still the safest and most effective way to protect Australians from vaccine-preventable disease. The Government is working towards increasing child immunisation rates over time by giving parents stronger incentives to have their children fully immunised. The Australian Immunisation Handbook, approved by the National Health and Medical Research Council (NHMRC), includes clinical information for Australian immunisation providers on the safest and most effective use of vaccines, new vaccines and vaccine-preventable diseases in Australia. It is also a valuable tool to help immunisation providers explain the benefits of immunisation to their patients. I’m confident that with your ongoing commitment, immunisation coverage rates will keep on improving. We need immunisation providers to take every available opportunity to appropriately vaccinate children and adults. We also need herd immunity to keep on growing, so that the risk of exposure to vaccine-preventable diseases such as pertussis and measles is minimised as far as possible. This Handbook includes information on changes to the National Immunisation Program. This includes, for example, the recent extension of the Human Papillomavirus (HPV) Vaccination Program to include males aged 12–13 years. Already the HPV vaccine has had an impact, significantly reducing the number of lesions that lead to cervical cancer amongst women in the vaccinated age group. Providing the HPV vaccine to boys will protect them and increase the effectiveness of the vaccination program for girls. By building on Australia’s world-class immunisation program, we are stopping vaccine-preventable diseases and that makes a difference to the quality of life for Australian families. Finally, I would like to thank the Chair, Professor Terry Nolan, and members of the Australian Technical Advisory Group on Immunisation, its working parties, technical writers and advisors for their work in producing this excellent resource. It will be a great help to everyone involved in supporting and delivering immunisation services in Australia. The Hon Tanya Plibersek MP Minister for Health iii iv The Australian Immunisation Handbook 10th edition TABLE OF CONTENTS PART 1 INTRODUCTION TO THE AUSTRALIAN IMMUNISATION HANDBOOK1 1.1Background 1 1.2 Development of the 10th edition of the Handbook3 1.3 How to use the 10th edition Handbook5 1.4 What’s new 1.5 Fundamentals of immunisation PART 2 VACCINATION PROCEDURES 7 18 24 2.1Pre-vaccination 24 2.2 65 Administration of vaccines 2.3Post-vaccination 85 PART 3 VACCINATION FOR SPECIAL RISK GROUPS 104 3.1 Vaccination for Aboriginal and Torres Strait Islander people 104 3.2 Vaccination for international travel 113 3.3 Groups with special vaccination requirements 130 PART 4 VACCINE-PREVENTABLE DISEASES 176 4.1Cholera 176 4.2Diphtheria 182 4.3 Haemophilus influenzae type b 191 4.4 Hepatitis A 198 4.5 Hepatitis B 208 4.6 Human papillomavirus 231 4.7Influenza 243 4.8 259 Japanese encephalitis 4.9Measles 267 4.10 283 Meningococcal disease 4.11Mumps 295 4.12Pertussis 302 4.13 317 Pneumococcal disease 4.14Poliomyelitis 338 4.15 Q fever 345 4.16 Rabies and other lyssaviruses (including Australian bat lyssavirus) 353 v 4.17Rotavirus 372 4.18Rubella 384 4.19Tetanus 397 4.20Tuberculosis 408 4.21Typhoid 416 4.22Varicella 423 4.23 Yellow fever 439 4.24 Zoster (herpes zoster) 446 PART 5 PASSIVE IMMUNISATION 456 5.1 456 Passive immunisation using immunoglobulin preparations APPENDICES465 APPENDIX 1: Contact details for Australian, state and territory government health authorities and communicable disease control 465 APPENDIX 2: Literature search strategy for the 10th edition of the Handbook467 APPENDIX 3: Components of vaccines used in the National Immunisation Program 469 APPENDIX 4: Commonly asked questions about vaccination 473 A.4.1 General questions 473 A4.2 Questions about contraindications and precautions 477 A4.3 Questions about vaccine safety 481 A4.4 Questions about vaccine content 484 A4.5 Questions about the need for immunisation 487 A4.6 Further information about vaccination 488 APPENDIX 5: Glossary of technical terms 489 APPENDIX 6: Commonly used abbreviations 495 APPENDIX 7: Overview of vaccine availability in Australia 498 INDEX500 vi The Australian Immunisation Handbook 10th edition LIST OF TABLES Table 2.1.1: Pre-vaccination screening checklist 30 Table 2.1.2:Responses to relevant conditions or circumstances identified through the pre-vaccination screening checklist 31 Table 2.1.3: Live attenuated parenteral and oral vaccines 37 Table 2.1.4: False contraindications to vaccination 38 Table 2.1.5:Minimum acceptable age for the 1st dose of scheduled vaccines in infants in special circumstances 46 Table 2.1.6: Number of vaccine doses that should have been administered by the current age of the child 49 Table 2.1.7: Minimum acceptable dose intervals for children <10 years of age 50 Table 2.1.8: Catch-up schedule for Haemophilus influenzae type b (Hib) vaccination for children <5 years of age 54 Table 2.1.9: Catch-up schedule for 13vPCV (Prevenar 13) for non-Indigenous children, and Indigenous children residing in the Australian Capital Territory, New South Wales, Tasmania and Victoria, who do not have any medical condition(s) associated with an increased risk of invasive pneumococcal disease (IPD), aged <5 years 56 Table 2.1.10: Catch-up schedule for 13vPCV (Prevenar 13) for Indigenous children residing in the Northern Territory, Queensland, South Australia or Western Australia ONLY, who do not have any medical condition(s) associated with an increased risk of invasive pneumococcal disease (IPD), aged <5 years 57 Table 2.1.11: Catch-up schedule for 13vPCV (Prevenar 13) and 23vPPV (Pneumovax 23) in children with a medical condition(s) associated with an increased risk of invasive pneumococcal disease (IPD), presenting at age <2 years 59 Table 2.1.12: Catch-up schedule for persons ≥10 years of age (for vaccines recommended on a population level) 63 Table 2.2.1: Route of administration for vaccines used in Australia 68 Table 2.2.2: Recommended needle size, length and angle for administering vaccines72 Table 2.3.1: Clinical features that may assist differentiation between a vasovagal episode and anaphylaxis 88 Table 2.3.2: Doses of intramuscular 1:1000 (one in one thousand) adrenaline for anaphylaxis 90 Table 2.3.3: Contact information for notification of adverse events following immunisation96 vii Table 3.1.1: Additional vaccines recommended for Indigenous persons, due to their higher risk of disease 105 Table 3.2.1: Dose and routes of administration of commonly used vaccines in adult travellers 123 Table 3.2.2: Recommended lower age limits of travel vaccines for children 127 Table 3.3.1: Recommendations for vaccination in pregnancy 135 Table 3.3.2: Recommendations for vaccinations for solid organ transplant (SOT) recipients 151 Table 3.3.3: Recommendations for revaccination following haematopoietic stem cell transplant (HSCT) in children and adults, irrespective of previous immunisation history 156 Table 3.3.4: Categories of immunocompromise in HIV-infected persons, based on age-specific CD4+ counts and percentage of total lymphocytes 158 Table 3.3.5: Recommendations for vaccination in persons with functional or anatomical asplenia 163 Table 3.3.6: Recommended intervals between either immunoglobulins or blood products and measles-mumps-rubella (MMR), measlesmumps-rubella-varicella (MMRV) or varicella vaccination 167 Table 3.3.7: Recommended vaccinations for persons at increased risk of certain occupationally acquired vaccine-preventable diseases 170 Table 4.4.1: Recommended doses and schedules for use of inactivated hepatitis A and hepatitis A combination vaccines 202 Table 4.5.1: Recommended schedules for use of monovalent hepatitis B and hepatitis B combination vaccines 214 Table 4.5.2: Accelerated hepatitis B vaccination schedules (for persons with imminent risk of exposure) 216 Table 4.5.3: Post-exposure prophylaxis for non-immune persons exposed to a HBsAg-positive source 229 Table 4.7.1: Recommended doses of influenza vaccine 251 Table 4.9.1: Recommendations for measles vaccination with (a) measlesmumps-rubella (MMR) (currently available), and (b) once measles-mumps-rubella-varicella (MMRV) vaccines are available from July 2013 273 Table 4.9.2: Post-exposure prophylaxis ≤72 hours since exposed to measles for non-immune individuals (adapted from Measles: national guidelines for public health units)281 Table 4.13.1: Recommendations for pneumococcal vaccination for children aged <5 years viii The Australian Immunisation Handbook 10th edition 325 List 4.13.1: Conditions associated with an increased risk of invasive pneumococcal disease (IPD) in children and adults, by severity of risk 326 Table 4.13.2:Recommendations for pneumococcal vaccination for children aged 2–5 years with a medical condition(s) associated with an increased risk of invasive pneumococcal disease (IPD) 328 Table 4.13.3:Recommendations for pneumococcal vaccination using 23vPPV for adults who do not have a condition(s) associated with an increased risk of invasive pneumococcal disease (IPD) 332 Table 4.15.1: Interpretation and action for serological and skin test results (with modifications from A guide to Q fever and Q fever vaccination (CSL Biotherapies, 2009)) 350 Table 4.16.1: Lyssavirus exposure categories 360 Table 4.16.2: Post-exposure prophylaxis commenced overseas and recommended completion in Australia 365 Table 4.17.1: Upper age limits for dosing of oral rotavirus vaccines 378 Table 4.19.1: Guide to tetanus prophylaxis in wound management 404 Table 4.22.1: Recommendations for varicella vaccination with (a) monovalent varicella vaccine (VV) (currently available), and (b) once measlesmumps-rubella-varicella (MMRV) vaccines are available from July 2013 428 Table 4.22.2: Zoster immunoglobulin-VF (ZIG) dose based on weight 436 Table A2.1: Electronic databases searched for the 10th edition 467 Table A3.1: Components of vaccines used in the National Immunisation Program 469 Table A7.1:Key dates when vaccines first came into widespread use in Australia 498 ix LIST OF FIGURES Figure 2.1.1: Catch-up worksheet for children <10 years of age for NIP vaccines45 Figure 2.2.1: Positioning a child <12 months of age in the cuddle position 75 Figure 2.2.2: Positioning an infant on an examination table for vaccination 76 Figure 2.2.3: Positioning an older child in the cuddle position 77 Figure 2.2.4: Positioning a child in the straddle position 78 Figure 2.2.5: Anatomical markers used to identify the vastus lateralis injection site (X) on the anterolateral thigh 79 Figure 2.2.6: The vastus lateralis injection site (X) on the anterolateral thigh 80 Figure 2.2.7: Anatomical markers used to identify the ventrogluteal injection site (X) 81 Figure 2.2.8: Anatomical markers used to identify the deltoid injection site 82 Figure 2.2.9: A subcutaneous injection into the deltoid area of the upper arm using a 25 gauge, 16 mm needle, inserted at a 45° angle 82 Figure 2.2.10: Recommended technique for giving multiple vaccine injections into the anterolateral thigh in an infant <12 months of age 83 Figure 4.7.1:Influenza notification rates 2006–2007 and hospitalisation rates 2005–2007, Australia, by age group 245 Figure 4.15.1:Q fever notifications for Australia, New South Wales and Queensland, 1991 to 2009 346 Figure 4.16.1:Post-exposure prophylaxis algorithm for potential exposure to classical rabies virus from a terrestrial animal overseas 366 Figure 4.16.2:Post-exposure prophylaxis algorithm for potential exposure to lyssaviruses from bats in Australia or overseas 367 Figure 4.16.3: Booster algorithm for persons at ongoing risk of exposure to either rabies or other lyssaviruses, including Australian bat lyssavirus (ABLV) 369 Figure 4.17.1: Rotavirus-coded hospitalisations per month, Australia, 2001 to 2010 373 x The Australian Immunisation Handbook 10th edition PREFACE The 10th edition of The Australian Immunisation Handbook was prepared by the Australian Technical Advisory Group on Immunisation of the Australian Government Department of Health and Ageing. Members of the Australian Technical Advisory Group on Immunisation Chair Professor Terry Nolan, Paediatrician; Epidemiologist and Head, School of Population Health, The University of Melbourne, Victoria Deputy Chair Associate Professor Peter Richmond, School of Paediatrics and Child Health, The University of Western Australia; General Paediatrician and Paediatric Immunologist, Princess Margaret Hospital for Children, Western Australia Voting and ex-officio members Associate Professor Ross Andrews, Menzies School of Health Research, Northern Territory Associate Professor Christopher Blyth, School of Paediatrics and Child Health, Faculty of Medicine, Dentistry and Health Sciences, The University of Western Australia, Princess Margaret Hospital, Western Australia (member from July 2012) Ms Sue Campbell-Lloyd, Manager, Immunisation Unit, AIDS/Infectious Diseases Branch, NSW Health, New South Wales (member until June 2012) Dr Grahame Dickson, Medical Officer, Drug Safety and Evaluation Branch, Therapeutic Goods Administration, Australian Government Department of Health and Ageing, Australian Capital Territory (member until August 2012) Dr Nicole Gilroy, Infectious Diseases consultant, St Vincent’s Hospital, Sydney; Blood Marrow Transplant (BMT) Network, New South Wales Ms Madeline Hall, Public Health Nurse, Queensland Health, Queensland (member from July 2012) Clinical Professor David Isaacs, Senior Staff Specialist, Department of Infectious Diseases and Microbiology, The Children’s Hospital at Westmead and Paediatric Infectious Diseases, The University of Sydney, New South Wales Dr Rosemary Lester, Chief Health Officer, Department of Health, Victoria (member until December 2011) xi Dr Ting Lu, Medical Officer, Office of Medicines Authorisation, Market Authorisation Group, Therapeutic Goods Administration, Australian Government Department of Health and Ageing, Australian Capital Territory (member from September 2012) Professor Peter McIntyre, Professor of Paediatrics and Preventive Medicine, The University of Sydney; Director, National Centre for Immunisation Research and Surveillance of Vaccine Preventable Diseases, The Children’s Hospital at Westmead, New South Wales Associate Professor Jodie McVernon, School of Population Health, The University of Melbourne, Victoria (member from January 2012) Dr Joanne Molloy, General Practitioner, GP Association of Geelong, Victoria Ms Stephanie Newell, Consumer representative (member until June 2012) Associate Professor Michael Nissen, Director of Infectious Diseases and Clinical Microbiologist, Unit Head of Queensland Paediatric Infectious Disease Laboratory; Associate Professor in Biomolecular, Biomedical Science and Health, Royal Children’s Hospital, Queensland (member until June 2012) Dr Rod Pearce, General Practitioner, Medical Officer of Health, Eastern Health Authority, Adelaide; GP Immunisation Advisor, Adelaide Central and Eastern Division of General Practice, South Australia (member until June 2012) Ms Karen Peterson, Immunisation Manager, Queensland Health, Queensland (member from July 2012) Ms Debra Petrys, Consumer representative (member from July 2012) Ms Helen Pitcher, Public Health Nurse, Department of Human Services, Victoria (member until June 2012) Ms Julianne Quaine, Assistant Secretary, Health Protection Programs Branch, Office of Health Protection, Australian Government Department of Health and Ageing, Australian Capital Territory Dr Greg Rowles, General Practitioner, Riddells Creek, Victoria (member from July 2012) Dr Christine Selvey, Communicable Diseases Network Australia, Queensland Health, Queensland (member from January 2012) Professor Steven Wesselingh, Executive Director, South Australian Health and Medical Research Institute, South Australia (member from July 2012) Secretary Ms Monica Johns, Director, Immunisation Policy Section, Immunisation Branch, Office of Health Protection, Australian Government Department of Health and Ageing, Australian Capital Territory xii The Australian Immunisation Handbook 10th edition Secretariat support, Australian Technical Advisory Group on Immunisation Ms Sandy Anderson; Ms Jessica Hutchison Senior technical editor Associate Professor Kristine Macartney, Deputy Director Government Programs, National Centre for Immunisation Research and Surveillance of Vaccine Preventable Diseases, The Children’s Hospital at Westmead; Discipline of Paediatrics and Child Health, The University of Sydney Technical editor Dr Jane Jelfs, Manager Policy Support, National Centre for Immunisation Research and Surveillance of Vaccine Preventable Diseases Assistant technical editor Dr Melina Georgousakis, Research Officer, National Centre for Immunisation Research and Surveillance of Vaccine Preventable Diseases Senior technical writer Dr Clayton Chiu, Public Health Physician, National Centre for Immunisation Research and Surveillance of Vaccine Preventable Diseases Technical writers Mr Brett Archer; Ms Kathryn Cannings; Dr Bradley Christian; Dr Nigel Crawford; Dr Aditi Dey; Dr Anita Heywood; Dr Sanjay Jayasinghe; Dr Robert Menzies; Dr Helen Quinn; Dr Tom Snelling; Ms Kirsten Ward; Dr Nicholas Wood Editorial support Ms Donna Armstrong, Editing and Publications Officer, National Centre for Immunisation Research and Surveillance of Vaccine Preventable Diseases Library support Ms Catherine King, Information Manager, National Centre for Immunisation Research and Surveillance of Vaccine Preventable Diseases Mr Edward Jacyna, Assistant Librarian, National Centre for Immunisation Research and Surveillance of Vaccine Preventable Diseases Administration support Ms Lyn Benfield, Senior Administration Project Officer, National Centre for Immunisation Research and Surveillance of Vaccine Preventable Diseases xiii Acknowledgments Dr Frank Beard Dr Vicki Krause Professor Julie Bines Associate Professor Stephen Lambert Dr Julia Brotherton Associate Professor Amanda Leach Associate Professor Tony Brown Professor Raina MacIntyre Professor Margaret Burgess Professor John Mackenzie Dr Dave Burgner Associate Professor Guy Marks Dr Jim Buttery Dr Jeremy McAnulty Professor Jonathan Carapetis Dr Brad McCall Dr Ben Cowie Dr Elizabeth McCarthy Dr Andrew Daley Dr Neil Parker Professor Basil Donovan Professor Bill Rawlinson Dr Mark Douglas Associate Professor Tilman Ruff Professor David Durrheim Dr Rosalie Schultz Professor Dominic Dwyer Dr Vicky Sheppeard Professor Joan Faoagali Associate Professor Vitali Sintchenko Dr Tony Gherardin Associate Professor Monica Slavin Dr Heather Gidding Associate Professor David Smith Professor Lyn Gilbert Dr Bruce Thorley Dr Robert Hall Dr Joe Torressi Dr Alan Hampson Dr Siranda Torvaldsen Dr Penny Hutchinson Ms Maureen Watson Dr Heath Kelly Dr Rosalind Webby Professor Michael Kidd Dr Melanie Wong Dr Anne Koehler Professor Nick Zwar xiv The Australian Immunisation Handbook 10th edition