Europe — EMA
Hexacima
Hexacima is an EU‑approved Hib, diphtheria and tetanus combination vaccine for intramuscular use, providing active immunity against these bacterial diseases.
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What is Haemophilus Influenzae Type B Polysaccharide (Polyribosylribitol Phosphate), Diphtheria Toxoid, Teta?
Hexacima is a combination vaccine containing Haemophilus influenzae type b polysaccharide, diphtheria toxoid, and tetanus toxoid, supplied in an injectable form for intramuscular administration. It is marketed in the European Union and prescribed by health professionals to induce immunity against Hib disease, diphtheria, and tetanus. The product is prescription‑only and administered by a qualified provider. It is classified under ATC code J07AG and belongs to the vaccine therapeutic class.
What is Haemophilus Influenzae Type B Polysaccharide (Polyribosylribitol Phosphate), Diphtheria Toxoid, Teta used for?
Hexacima is indicated for active immunization against three bacterial diseases in individuals for whom vaccination is recommended. The vaccine is used in routine pediatric schedules and in catch‑up programs for children and adolescents who have not completed the primary series. - Prevention of invasive disease caused by Haemophilus influenzae type b (Hib), including meningitis and pneumonia. - Protection against diphtheria caused by Corynebacterium diphtheriae toxin. - Protection against tetanus caused by Clostridium tetani toxin. - Inclusion in combination immunization schedules to reduce the number of injections. - Use in travelers to regions where Hib, diphtheria, or tetanus are endemic.
What are the side effects of Haemophilus Influenzae Type B Polysaccharide (Polyribosylribitol Phosphate), Diphtheria Toxoid, Teta?
Following intramuscular injection, Hexacima may be associated with local and systemic reactions, most of which are mild and self‑limiting.
Common: - Pain, redness, or swelling at the injection site, typically lasting 1–2 days. - Mild fever (up to 38 °C) occurring within 24 hours of vaccination. - Irritability or fussiness, especially in infants and toddlers, that resolves spontaneously. - Headache or mild fatigue reported by older children and adults.
Serious: - Severe allergic reaction (anaphylaxis) characterized by hives, airway swelling, or low blood pressure. - High fever of 40 °C or higher, possibly accompanied by chills. - Seizures or convulsions, particularly in infants with fever. - Persistent crying, inconsolable distress, or neurologic signs such as hypotonia.
What precautions apply to Haemophilus Influenzae Type B Polysaccharide (Polyribosylribitol Phosphate), Diphtheria Toxoid, Teta?
Healthcare providers should assess individual risk factors before administering Hexacima and observe patients for appropriate periods after injection. - Known hypersensitivity to any vaccine component, including latex in the vial stopper. - History of severe allergic reaction to a previous dose of Hib, diphtheria, or tetanus vaccine. - Acute moderate or severe illness with fever at the time of vaccination. - Immunocompromised patients may have a reduced antibody response; vaccination should follow clinical guidelines. - Pregnancy and lactation status should be considered; vaccine is generally avoided unless benefits outweigh risks. - Children with neurological disorders should be monitored for febrile seizures post‑vaccination.
What does Haemophilus Influenzae Type B Polysaccharide (Polyribosylribitol Phosphate), Diphtheria Toxoid, Teta interact with?
Hexacima does not have many documented drug‑drug interactions, but certain conditions and medications may influence its safety or effectiveness.
Avoid: - Concurrent administration of live viral vaccines (e.g., measles, mumps, rubella) within 4 weeks, due to potential immune interference. - Use of immunoglobulin or blood products within 3 days before or after vaccination, which may neutralize the antigens.
Use with caution: - Systemic corticosteroids or other immunosuppressants may diminish antibody response; consider timing. - Antipyretics (acetaminophen, ibuprofen) can be given to manage post‑vaccination fever, but routine prophylactic use may blunt immune response. - Severe allergic history warrants observation in a setting equipped for emergency care.
Frequently asked questions
What diseases does Hexacima protect against?+
Is Hexacima administered orally or by injection?+
Can adults receive Hexacima, or is it only for children?+
What should I do if I develop a fever after receiving Hexacima?+
Are there any contraindications for Hexacima?+
How long does immunity last after a full series of Hexacima?+
Can Hexacima be given at the same time as other vaccines?+
Is Hexacima safe for pregnant women?+
What are the most common side effects of Hexacima?+
What should I tell my doctor before receiving Hexacima?+
Does Hexacima require a prescription?+
How is Hexacima stored before use?+
Product details
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