Home > Package Inserts > Boostrix-IVP
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Diphtheria
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Tetanus (lockjaw)
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Pertussis (whooping cough)
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Poliomyelitis (polio)
1 dose (0.5 ml) also contains:
Aluminium hydroxide hydrate - ​An adjuvant. An ingredient used in some vaccines that helps create a stronger immune response in people receiving the vaccine. (1) As a medication it is also used in the management and treatment of heartburn, upset stomach, sour stomach, or acid indigestion. It is also used in cosmetics and as a fire retardant filler for polymer applications.
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Aluminium phosphate - An adjuvant. An ingredient used in some vaccines that helps create a stronger immune response in people receiving the vaccine. (1) It is also used in cake mixes and in some baking powders as a leavening agent to help baked goods rise. Medicinally it is used as adsorbent for toxoids. It is also used industrially as a high-temperature dehydrating agent. (2)
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Sodium chloride (salt) - commonly known as table salt.
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Medium 199 (which contains phenylalanine) - a synthetic medium. It also contains combination of vitamins, amino acids, and other factors that were originally developed as a completely defined media formulation for the culture of primary explants. This medium, when properly supplemented has broad applicability, particularly for non-transformed cells. Medium 199 is widely used for vaccine production, in vitro cultivation of primary pancreatic explants, and lens tissues.
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Phenylalanine is an amino acid. It may be harmful if you have phenylketonuria (PKU), a rare genetic disorder in which phenylalanine builds up because the body cannot remove it properly.
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Water for injections
Traces of:
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Formaldehyde - Formaldehyde can occur naturally in the environment. Formaldehyde is released during the combustion of organic materials, and as such may be present in smoke from wood fires, automobile emissions, tobacco smoke and from burning incense.
​A highly toxic systemic poison. The International Agency for Research on Cancer (IARC) is part of the World Health Organization (WHO). One of its major goals is to identify causes of cancer. IARC has concluded that formaldehyde is "carcinogenic to humans" based on sufficient evidence it can cause nasopharyngeal cancer and leukemia.
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Polysorbate 80 - also known as Tween 80, is a synthetic nonionic surfactant commonly used in food, cosmetics, and drug formulations as a solubilizer, stabiliser, or emulsifier.
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Neomycin sulfate - antibiotic class of drugs.
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Polymyxin sulfate - antibiotic class of drugs.
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​The manufacture of this product includes exposure to bovine derived materials.
WARNINGS AND PRECAUTIONS
Carcinogenesis and Mutagenesis
BOOSTRIX-IPV has not been evaluated for carcinogenic or mutagenic potential.
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BOOSTRIX-IPV contains traces of neomycin sulfate and polymyxin sulfate. The vaccine should be used with caution in patients with known hypersensitivity to either of these antibiotics.
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​As with any vaccine, a protective immune response may not be elicited in all vaccinees.
Frequencies per dose are defined and colour coded as follows:
Very common - (≥1/10)
Common - ≥1/100 to <1/10
Uncommon - ≥1/1,000 to <1/100
Rare - ≥1/10,000 to <1/1,000
Very rare - <1/10,000
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Side effects that are not colour coded are of unknown frequency.
Side effects in trials
Side effects postmarketing
Side effects that occurred in children from the age of 4 to 9 years:
Blood and lymphatic system disorders
Lymphadenopathy
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Gastrointestinal disorders
Diarrhoea
Vomiting
Abdominal pain
Nausea
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General disorders and administration site conditions
Pain
Sleepiness
Redness at the injection site (including pain, redness and swelling)
Fever ≥ 37.5 °C (including fever > 39°C)
Injection site reactions (such as haemorrhage)
Large swelling of the vaccinated limb
Fatigue
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Metabolism and nutrition disorders
Loss of appetite
Anorexia
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Nervous system disorders
Somnolence
Headache
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Psychiatric disorders
Irritability
Sleep disorder
Apathy
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Respiratory, thoracic and mediastinal disorders
Dry throat
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Skin and subcutaneous tissue disorders
Rash
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Side effects that occurred during clinical trials in adults, teenagers and children from the age of 10 years onwards:
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Blood and lymphatic system disorders
Lymphadenopathy
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Gastrointestinal disorders
Diarrhoea
Vomiting
Abdominal pain
Nausea
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General disorders and administration site conditions
Redness at the injection site (including pain, redness and swelling)
Fatigue
Fever ≥ 37.5 °C, injection site reactions (such as haematoma)
Fever > 39 °C
Chills
Pain
Infections and infestations
Oral herpes
Metabolism and nutrition disorders
Decreased appetite
Musculoskeletal and connective tissue disorders
Myalgia
Arthralgia
Nervous system disorders
Headache
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Respiratory, thoracic and mediastinal disorders
Asthma
Skin and subcutaneous tissue disorders
Pruritus
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Blood and lymphatic system disorders
​Angioedema
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Immune system disorders
Allergic reactions, including anaphylactic and anaphylactoid reactions
Nervous system disorders
Convulsions (with or without fever)
Skin and subcutaneous tissue disorders
Urticaria
General disorders and administration site conditions
Extensive swelling of the vaccinated limb
Asthenia
Injection site induration
*side effect list is a combination of Europe and Australia.
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Manufacturer's Pacakge Insert Side Effects*
References
1. Drugbank https://go.drugbank.com/drugs/DB00742
2. Formaldehyde: general information https://www.gov.uk/government/publications/formaldehyde-properties-incident-management-and-toxicology/formaldehyde-general-information
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