top of page

Home > Package Inserts > Infanrix Hexa

Infanrix Hexa (6 in 1)

Childhood vaccine given at 8,12 and 16 weeks old.

Deep intramuscular injection.

Download package inserts
Australia
Canada
Europe

Manufactured by GlaxoSmithKline

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. 

​

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)

​

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)

​

VERO cells - derived from the kidney of an African green monkey.

​

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)

​

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.

​

Sodium chloride (NaCl) - commonly known as table salt.

 

Sodium - mineral salts.

​

Potassium - mineral salts.

​

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)

​

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. (7A 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.

​

​

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.

​

*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

​

Metabolism and nutrition disorders

Appetite lost

​

Psychiatric disorders

Crying abnormal

Irritability

Restlessness

Nervousness

​

Nervous system disorders

Somnolence
Convulsions (with or without fever)

​

Respiratory, thoracic and mediastinal disorders

Cough
Bronchitis

Apnoea

Laryngitis

Stridor

Bronchospasm

​

Gastrointestinal disorders

Diarrhoea

Vomiting

Enteritis

Gastroenteritis

Abdominal pain

Constipation

​

Skin and subcutaneous tissue disorders

Pruritus

Rash

Angioedema
Dermatitis

Urticaria

​

Vision

Conjunctivitis

​

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

​

​

​

​

Blood and Lymphatic System Disorders
Lymphadenopathy

Thrombocytopenia

​

Immune System Disorders

Anaphylactic reactions

Anaphylactoid reactions (including urticaria)
Allergic reactions (including pruritus)

​

Nervous system disorders

Collapse or shock-like state (hypotonic-hyporesponsive episode)
Convulsions (with or without fever)

​

Respiratory, thoracic and mediastinal disorders

Apnoea

​

Skin and subcutaneous tissue disorders

Angioneurotic oedema

​

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.

​

Manufacturer's Pacakge Insert Side Effects*
bottom of page