GNH USA

Europe — EMA

Hexacima

Hexacima vaccine – EU‑approved Hib, diphtheria and tetanus combination for intramuscular immunization. Indications, mechanism, safety and precautions.

Haemophilus Influenzae Type B Polysaccharide (Polyribosylribitol Phosphate), Diphtheria Toxoid, Teta

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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?+
Hexacima provides immunization against Haemophilus influenzae type b infection, diphtheria, and tetanus.
How many doses of Hexacima are required for full protection?+
The recommended schedule typically includes a primary series of two or three doses, followed by a booster dose, but the exact number depends on age and prior vaccination history.
Can Hexacima be given together with other childhood vaccines?+
Yes, Hexacima can be administered concomitantly with other inactivated vaccines, though injection sites should be separate and patients monitored for increased local reactions.
What are the common side effects after receiving Hexacima?+
Common reactions include pain, redness or swelling at the injection site, low‑grade fever, mild fatigue, irritability, headache, and mild muscle aches.
Is Hexacima safe for pregnant women?+
The pregnancy safety category is listed as unknown; pregnant or breastfeeding women should discuss potential risks and benefits with their healthcare provider.
What should be done if a severe allergic reaction occurs after Hexacima?+
If anaphylaxis is suspected, immediate medical attention is required, including administration of epinephrine and emergency care.
How does the Hib component in Hexacima work?+
The Hib polysaccharide is conjugated to a protein carrier, enabling a T‑cell dependent immune response that produces protective antibodies against the bacterial capsule.
Does prior immunization with separate Hib, diphtheria, or tetanus vaccines affect Hexacima administration?+
Previous receipt of individual Hib, diphtheria, or tetanus vaccines does not contraindicate Hexacima, but timing should follow local immunization guidelines to avoid unnecessary duplication.
What storage conditions are recommended for Hexacima?+
Hexacima should be stored in a refrigerator between 2 °C and 8 °C, protected from light, and not frozen.
Who should avoid receiving Hexacima?+
Individuals with a known severe allergy to any component of the vaccine, or those with a history of severe allergic reactions to previous vaccines, should avoid Hexacima.
Can Hexacima be given to immunocompromised patients?+
Hexacima is an inactivated vaccine and can be administered to immunocompromised individuals, but immune response may be reduced; clinicians should assess each case individually.
What is the route of administration for Hexacima?+
Hexacima is administered by intramuscular injection, typically into the deltoid muscle for adults or the anterolateral thigh for infants.
Information provided on this page is for educational use by procurement and clinical professionals. Always consult a licensed healthcare provider for medical advice and prescribing decisions. GNH USA supplies this product subject to applicable regulatory and licensing requirements.

Product details

Drug
Haemophilus Influenzae Type B Polysaccharide (Polyribosylribitol Phosphate), Diphtheria Toxoid, Teta
Route
Intramuscular Use
Manufacturer
Sanofi Winthrop Industrie
Origin
EU

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