Hexaxim SC Injection

DTaP-IPV-HB-Hib is indicated for primary and booster vaccination of infants and toddlers from six weeks of age against diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and invasive diseases caused by Haemophilus influenzae type b (Hib).

One dose (0.5 ml) contains:

• Diphtheria toxoid: 20 IU
• Tetanus toxoid 40: IU
• Bordetello pertussisantigens: 25 µg
• Pertusis toxoid Filamentous haemagglutinin: 25 µg
• Poliovirus (inactivated) Type1 (Mahoney) Type 2: 40 DU
• (MEF-1): 8 DU
• Type3 (Saukett): 32 DU
• Hepatitis Bsurfaceantigens 10 µg
• Hoemophilusinfluenzoe type b polysaccharide (polyribosylribitol phosphate): 12 µg
• conjugated to Tetanusprotein (PRP-T): 22-36 µg

Primary Vaccination: 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 after a previous administration of this vaccine Encephalopathy within 7 days of administration of a previous dose of any vaccine containing pertussis antigens (whole cell or acellular pertussis vaccines). Uncontrolled neurologic disorder, uncontrolled epilepsy.

Serious Allergic reactions (anaphylactic reaction): Difficulty in breathing, blueness of tongue/lips, a rash, swelling of face/throat, sudden and dizziness, loss of consciousness, accelerated heart rate with respiratory disorders. Serious allergic reactions are a rare possibility (may up to 1 in 1,000 people) after receiving this vaccine. Other side effects:

• Very common: Anorexia, crying, somnolence, vomiting, pain redness and swelling at injection site, irritability, Fever
• Common side effects: Prolonged crying, diarrhoea, induration
• Uncommon side effects: Allergicreaction, lump at injection site, High fever.

Vaccination must be postponed in cases of moderate or severe febrile and/or acute disease; the administration of Hexaxim must be carefully considered in individuals who have a history of serious or severe reactions within 48 hours following administration of a vaccine containing similar components. As with all injectable vaccines, the vaccine must be administered with caution to subjects with thrombocytopenia or a bleeding disorder since bleeding may occur following an intramuscular administration. If any of the following events are known to have occurred after receiving any pertussis-containing vaccine, the decision to give further doses of pertussis containing vaccine should be carefully considered:

• The temperature of ≥40°C within 48 hours not due to another identifiable cause;
• Collapse or shock-like state (hypotonic-hyporesponsive episode) within 48 hours of vaccination;
• Persistent, inconsolable crying lasting ≥ 3 hours, occurring within 48 hours of vaccination;
• Convulsions with or without fever, occurring within 3 days of vaccination. Take special care in case of Guillain Barré Syndrome, Brachial neuritis, acute or chronic renal insufficiency, 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 at +2°C to +8 °C. Do not freeze. Discard solution if frozen. Protect from light.