Europe — EMA
Hexacima
Hexacima vaccine – EU‑approved Hib, diphtheria and tetanus combination for intramuscular immunization. Indications, mechanism, safety and precautions.
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What is Haemophilus Influenzae Type B Polysaccharide (Polyribosylribitol Phosphate), Diphtheria Toxoid, Teta?
Hexacima is a vaccine that combines Haemophilus influenzae type b polysaccharide (PRP), diphtheria toxoid, and tetanus toxoid. It is supplied as a liquid for intramuscular injection. Marketed in the European Union, Hexacima is classified under ATC code J07AG and is intended to stimulate active immunity against Hib, diphtheria, and tetanus. The formulation follows EU regulatory standards and is administered by a healthcare professional as part of routine immunization schedules.
What is Haemophilus Influenzae Type B Polysaccharide (Polyribosylribitol Phosphate), Diphtheria Toxoid, Teta used for?
Hexacima is indicated for active immunization against three bacterial diseases and is incorporated into standard vaccination programs for children and adolescents. The vaccine can be administered as a primary series or as a booster dose, depending on the patient’s age and previous immunization history. - Prevention of invasive Haemophilus influenzae type b disease. - Protection against diphtheria caused by Corynebacterium diphtheriae. - Protection against tetanus caused by Clostridium tetani toxin. - Inclusion in routine infant and toddler immunization schedules. - Use as a booster dose in older children, adolescents, or adults who have completed the primary series.
What are the side effects of Haemophilus Influenzae Type B Polysaccharide (Polyribosylribitol Phosphate), Diphtheria Toxoid, Teta?
Hexacima, like other injectable vaccines, may be associated with local and systemic reactions. Most reactions are mild and resolve without intervention. Common: - Pain, redness, or swelling at the injection site. - Low‑grade fever (≤38.5 °C) within 24 hours. - Mild fatigue or irritability, especially in children. - Headache or mild muscle aches. - Mild redness or warmth around the injection site lasting 1–2 days. Serious: - Severe allergic reaction (anaphylaxis) with hives, airway swelling, or hypotension. - High fever (>40 °C) persisting more than 48 hours. - Neurological signs such as seizures or prolonged crying. - Signs of Guillain‑Barré syndrome (weakness, tingling). - Severe local reaction with extensive swelling or necrosis. - Unexplained bleeding or bruising at the injection site.
What precautions apply to Haemophilus Influenzae Type B Polysaccharide (Polyribosylribitol Phosphate), Diphtheria Toxoid, Teta?
Healthcare providers should evaluate patient history before administering Hexacima to minimize risk and ensure appropriate use. - Defer vaccination in individuals with a known severe allergy to any vaccine component. - Postpone if the patient has an acute moderate or severe illness with fever. - Observe for at least 15 minutes after injection for immediate hypersensitivity reactions. - Use caution in persons with a history of Guillain‑Barré syndrome. - Pregnant or breastfeeding women should discuss risks and benefits with a clinician. - Do not administer intravascularly; ensure proper intramuscular technique. - Report any unexpected adverse events to pharmacovigilance authorities.
What does Haemophilus Influenzae Type B Polysaccharide (Polyribosylribitol Phosphate), Diphtheria Toxoid, Teta interact with?
Vaccines may interact with other medical products or conditions that affect immune response. Consider the following when planning administration of Hexacima. Avoid: - Concurrent administration with live viral vaccines (e.g., measles, mumps, rubella) unless recommended by guidelines. - Use in individuals receiving immunosuppressive therapy that markedly reduces antibody production. Use with caution: - Simultaneous receipt of other inactivated vaccines; monitor for increased local reactions. - Patients on high‑dose corticosteroids may have reduced immunogenicity. - Individuals with a history of severe allergic reactions to previous vaccines. - Administration during acute febrile illness may obscure vaccine‑related fever. - Patients receiving blood products or immunoglobulins within 3 months should be evaluated for possible interference with vaccine response.
Frequently asked questions
What diseases does Hexacima protect against?+
How many doses of Hexacima are required for full protection?+
Can Hexacima be given together with other childhood vaccines?+
What are the common side effects after receiving Hexacima?+
Is Hexacima safe for pregnant women?+
What should be done if a severe allergic reaction occurs after Hexacima?+
How does the Hib component in Hexacima work?+
Does prior immunization with separate Hib, diphtheria, or tetanus vaccines affect Hexacima administration?+
What storage conditions are recommended for Hexacima?+
Who should avoid receiving Hexacima?+
Can Hexacima be given to immunocompromised patients?+
What is the route of administration for Hexacima?+
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