Europe — EMA
Hexyon
Hexyon vaccine overview: composition, indications, mechanism, side effects, precautions, and interactions for EU‑approved immunization.
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What is Haemophilus Influenzae Type B Polysaccharide (Polyribosylribitol Phosphate), Diphtheria Toxoid, Teta?
Hexyon is an injectable vaccine containing Haemophilus influenzae type b polysaccharide, diphtheria toxoid, tetanus toxoid, pertussis antigens, inactivated poliovirus and hepatitis B surface antigen. Formulated as a sterile liquid for intramuscular administration, the preparation is marketed in the European Union for use in pediatric and adolescent immunization schedules. It is a prescription‑only product designed to stimulate active immunity against multiple bacterial and viral diseases through protective antibody responses.
What is Haemophilus Influenzae Type B Polysaccharide (Polyribosylribitol Phosphate), Diphtheria Toxoid, Teta used for?
Hexyon is indicated for active immunization against several infectious diseases in children and adolescents according to recommended vaccination schedules. - Diphtheria, providing protection against Corynebacterium diphtheriae toxin in infants and children. - Tetanus, inducing immunity to tetanus neurotoxin after primary series. - Pertussis (whooping cough), targeting Bordetella pertussis antigens to reduce severe cough episodes. - Poliomyelitis, preventing disease caused by poliovirus types 1, 2 and 3 in children. - Haemophilus influenzae type b infection, reducing risk of invasive H. influenzae disease, especially meningitis. - Hepatitis B, stimulating antibodies to hepatitis B surface antigen for long‑term protection.
What are the side effects of Haemophilus Influenzae Type B Polysaccharide (Polyribosylribitol Phosphate), Diphtheria Toxoid, Teta?
Hexyon may cause local and systemic reactions, most of which are mild and transient.
Common: - Pain, redness or swelling at the injection site, typically lasting one to two days. - Low‑grade fever (usually ≤38.5 °C) occurring within 24 hours after vaccination. - Irritability or fussiness in infants and young children, often accompanied by mild sleep disturbance. - Mild headache or reduced appetite that resolves without medical intervention.
Serious: - Severe allergic reaction, including anaphylaxis, characterized by hives, difficulty breathing, or swelling of the face and throat. - High fever (≥40 °C) or seizures occurring shortly after the dose, requiring prompt evaluation. - Prolonged crying lasting more than three hours or signs of hypotension such as pale skin and lethargy.
What precautions apply to Haemophilus Influenzae Type B Polysaccharide (Polyribosylribitol Phosphate), Diphtheria Toxoid, Teta?
Before administering Hexyon, healthcare providers should assess the patient’s health status and vaccination history to minimize risks. - Do not give Hexyon to anyone with a severe allergy to any vaccine component, such as latex or yeast proteins. - Postpone vaccination if the person has a moderate or severe acute illness (e.g., fever, respiratory infection) until recovery. - Use caution in immunocompromised patients, as they may mount a reduced immune response. - Safety during pregnancy is not established; defer use unless the benefit outweighs potential risk. - Confirm the recipient meets the age and schedule requirements for the vaccine series. - Observe the patient for at least 15 minutes after injection to identify immediate reactions.
What does Haemophilus Influenzae Type B Polysaccharide (Polyribosylribitol Phosphate), Diphtheria Toxoid, Teta interact with?
Hexyon may interact with other vaccines or medications, and certain conditions require special consideration.
Avoid: - Simultaneous administration of Hexyon with live attenuated viral vaccines (e.g., measles‑mumps‑rubella) without an appropriate interval. - Concomitant use of high‑dose immunoglobulin or blood products that could neutralize vaccine antigens. - Administration during acute severe allergic reactions to other agents.
Use with caution: - Patients receiving immunosuppressive therapy, as the vaccine response may be diminished. - Individuals taking antipyretic or analgesic medications, which can mask fever after vaccination. - Persons with a history of seizures, who may need closer monitoring after immunization.
Frequently asked questions
What diseases does Hexyon protect against?+
Is Hexyon approved for use in the European Union?+
What is the route of administration for Hexyon?+
Can Hexyon be given together with other childhood vaccines?+
What are the most common side effects after Hexyon vaccination?+
Are there any serious adverse reactions associated with Hexyon?+
Should Hexyon be avoided in people with egg allergy?+
Is Hexyon safe for pregnant women?+
How does Hexyon stimulate immunity?+
What storage conditions are required for Hexyon?+
Can Hexyon be given to immunocompromised patients?+
What is the recommended observation period after Hexyon injection?+
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