Hexaxim is indicated for primary and booster vaccination of infants and toddlers from six weeks to 24 months of age against diphtheria, tetanus, pertussis, Hepatitis B, poliomyelitis, and invasive diseases caused by Haemophilus influenzae type b.

Primary vaccination: The primary vaccination schedule consists of three doses of 0.5 ml (such as 6, 10, 14 weeks; 2, 3, 4 months; 3, 4, 5 months; 2, 4, 6 months) administered at intervals of at least four weeks, according to official recommendations. All vaccination schedules, including the Expanded Program on Immunisation (at 6, 10, 14 weeks of age), may be followed whether or not a dose of Hepatitis B vaccine was given at birth.

One dose (0.5 ml) contains:

• Diphtheria toxoid: 20 IU
• Tetanus toxoid: 40 IU
• Bordetella pertussis antigens: 25 µg
• Pertussis toxoid: —
• Filamentous haemagglutinin: 25 µg
• Poliovirus (inactivated):
• Type 1 (Mahoney): 40 DU
• Type 2 (MEF-1): 8 DU
• Type 3 (Saukett): 32 DU
• Hepatitis B surface antigen: 10 µg
• Haemophilus influenzae type b polysaccharide (polyribosylribitol phosphate): 12 µg
• Conjugated to tetanus protein (PRP-T): 22–36 µg

PrimaryVaccination: Three injections at an interval of one to two months (at least four weeks apart).

Booster: At least 6 months after the last dose of first course. This vaccine should be used according to the local vaccination programme.

This should be administered intramuscularly. The recommended injection sites are generally the anterolateral aspect of the upper thigh in infants and toddlers and the deltoid muscle in older children. The intradermal or intravascular route must not be used.; ensure that the needle does not penetrate a blood vessel. Separate syringes, separate injection sites and preferably separate limbs must be used in case of the concomitant administration with other vaccines.

History of an anaphylactic reaction following a previous dose of this vaccine. Encephalopathy occurring within 7 days after administration of any vaccine containing pertussis antigens (whole-cell or acellular pertussis vaccines). Uncontrolled neurological disorders, including uncontrolled epilepsy.

Serious allergic reactions (anaphylactic reaction): Difficulty in breathing, bluish discoloration of tongue or lips, rash, swelling of face or throat, sudden dizziness, loss of consciousness, rapid heart rate associated with respiratory distress. These reactions are rare (up to 1 in 1,000 people).

Other side effects:

• Very common: Anorexia, crying, somnolence, vomiting, pain, redness and swelling at the injection site, irritability, fever.
• Common: Prolonged crying, diarrhoea, induration.
• Uncommon:Allergic reactions, lump at injection site, high fever.

Vaccination should be postponed in cases of moderate or severe febrile illness and/or acute disease. Administration of Hexaxim should be carefully considered in individuals with a history of serious or severe reactions within 48 hours after receiving a vaccine containing similar components.

As with all injectable vaccines, caution should be exercised in individuals with thrombocytopenia or bleeding disorders, as bleeding may occur after intramuscular injection.

If any of the following events have occurred after receiving a pertussis-containing vaccine, careful consideration is required before administering further doses:

• Temperature ≥40°C within 48 hours, not attributable to another cause
• Collapse or shock-like state (hypotonic-hyporesponsive episode) within 48 hours
• Persistent, inconsolable crying lasting ≥3 hours within 48 hours
• Convulsions with or without fever occurring within 3 days

Special caution is required in patients with Guillain-Barré Syndrome, brachial neuritis, acute or chronic renal insufficiency, and epilepsy.

Vaccines, Anti-sera & Immunoglobulin

Keep out of the reach and sight of children. Store at +2°C to +8°C. Transportation should also be maintained at +2°C to +8°C. Do not freeze. Discard the solution if frozen. Protect from light.