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Home > Package Inserts > Boostrix-IVP

Boostrix-IVP

Childhood vaccine given at 3 year and 4 months old.

Whooping cough vaccine in pregnancy.

Intramuscular injection.

Also known as Boostrix Polio, Boostrix Tetra
View package insert
Australia
Europe (requested)
Not available in the USA

Manufactured by GlaxoSmithKline Biologicals S.A.

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  • Diphtheria

  • Tetanus (lockjaw)

  • Pertussis (whooping cough)

  • 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*
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