Home > Package Inserts > Infanrix Hexa
1 dose (0.5 ml) also contains:
Aluminium hydroxide, hydrated (0.5mg) - 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 (0.32mg) - 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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Yeast cells (Saccharomyces cerevisiae) by recombinant DNA technology - recombination of DNA molecules from two different species that are inserted into a host organism to produce new genetic combinations that can be used for protein manufacture (biomanufacturing). (3)
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VERO cells - derived from the kidney of an African green monkey.
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Para-aminobenzoic acid - a natural substance. It is often used in sunscreen products. PABA is sometimes called vitamin Bx, but it is not a true vitamin. (4) It may cause allergic reactions (possibly delayed), and exceptionally, bronchospasm. (5)
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Phenylalanine - 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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Sodium chloride (NaCl) - commonly known as table salt.
Sodium - mineral salts.
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Potassium - mineral salts.
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Lactose anhydrous - milk sugar. People who are specifically "allergic" to lactose (not just lactose intolerant) should not use medications containing lactose, or ask their health care provider prior to use. (6)
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Residuals from the manufacturing process:
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. (7) 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. (8)
Neomycin - antibiotic class of drugs.
Polymyxin - antibiotic class of drugs.
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* Formaldehyde is listed only on Euepean manufacturer's package insert.
WARNINGS AND PRECAUTIONS
An increase in local reactogenicity* and fever was reported after booster vaccination with Infanrix hexa with respect to the primary course.
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*reactogenicity - the capacity of a vaccine to produce common, "expected" adverse reactions.
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
Side effects in trials
Side effects postmarketing
Infections and Infestation
Upper respiratory tract infection
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Metabolism and nutrition disorders
Appetite lost
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Psychiatric disorders
Crying abnormal
Irritability
Restlessness
Nervousness
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Nervous system disorders
Somnolence
Convulsions (with or without fever)
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Respiratory, thoracic and mediastinal disorders
Cough
Bronchitis
Apnoea
Laryngitis
Stridor
Bronchospasm
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Gastrointestinal disorders
Diarrhoea
Vomiting
Enteritis
Gastroenteritis
Abdominal pain
Constipation
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Skin and subcutaneous tissue disorders
Pruritus
Rash
Angioedema
Dermatitis
Urticaria
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Vision
Conjunctivitis
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General disorders and administration site conditions
Pain
Redness
Local swelling at the injection site (≤ 50 mm)
Fever ≥ 38°C
Fever >39.5°C
Injection site reactions
Injection site induration
Local swelling at the injection site (> 50 mm)
Diffuse swelling of the injected limb, sometimes involving the adjacent joint
Fatigue
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Blood and Lymphatic System Disorders
Lymphadenopathy
Thrombocytopenia
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Immune System Disorders
Anaphylactic reactions
Anaphylactoid reactions (including urticaria)
Allergic reactions (including pruritus)
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Nervous system disorders
Collapse or shock-like state (hypotonic-hyporesponsive episode)
Convulsions (with or without fever)
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Respiratory, thoracic and mediastinal disorders
Apnoea
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Skin and subcutaneous tissue disorders
Angioneurotic oedema
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General disorders and administration site conditions
Extensive swelling reactions
Swelling of the entire injected limb
Vesicles at the injection site
*side effect list is a combination of Infanrix Hexa Europe, Canada and Australia.
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Manufacturer's Pacakge Insert Side Effects*
References
1. CDC https://www.cdc.gov/vaccinesafety/concerns/adjuvants.html
2. National Library of Medicine https://pubchem.ncbi.nlm.nih.gov/compound/Aluminum-Phosphate
3. Gustave Y. https://www.chegg.com/flashcards/lecture-1-63218b62-5768-45fb-a671-d95f91a7414e/deck
4. Medline https://medlineplus.gov/ency/article/002518.htm
5. Infanrix hexa package inserts Europe and Australia
6. Drugs.com https://www.drugs.com/inactive/lactose-anhydrous-398.html
7. Formaldehyde: general information.
https://www.gov.uk/government/publications/formaldehyde-properties-incident-management-and-toxicology/formaldehyde-general-information
8. Cancer.org https://www.cancer.org/cancer/risk-prevention/chemicals/formaldehyde.html
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