Haemophilus influenzae type B (Hib) vaccine.
Each single dose of vaccine is formulated to contain purified capsular polysaccharide 10 mcg covalently bound to tetanus toxoid approximately 30 mcg. It also contains the following excipients: Lyophilised Hib Vaccine: Lactose. Diluent: Sterile saline solution.
Hiberix is a lyophilised vaccine of purified polyribosyl-ribitol-phosphate capsular polysaccharide (PRP) of Hib, covalently bound to tetanus toxoid.
The Hib polysaccharide is prepared from Hib, strain 20,752 and after activation with cyanogen bromide and derivatisation with an adipic hydrazide spacer is coupled to tetanus toxoid via carbodiimide condensation. After purification, the conjugate is lyophilised in the presence of lactose as stabiliser.
Hiberix meets the World Health Organization (WHO) requirements for the manufacture of biological substances and Hib conjugated vaccines.
Pharmacotherapeutic Group: Bacterial vaccines. ATC Code: J07AG01.
Pharmacology: Pharmacodynamics: A titre of ≥0.15 mcg/mL was obtained in 95-100% of infants 1 month after the completion of the vaccination course. A titre of ≥0.15 mcg/mL was obtained in 100% of infants 1 month after the booster dose (94.7% with a titre of ≥10 mcg/mL).
Pharmacokinetics: Evaluation of pharmacokinetic properties is not required for vaccines.
Toxicology: Preclinical Safety Data: Not applicable.
Active immunisation of all infants from the age of 6 weeks against diseases caused by Hib.
Hiberix does not protect against disease due to other types of H. influenzae nor against meningitis caused by other organisms.
Dosage: The primary vaccination schedule consists of 3 doses in the first 6 months of life and can start from the age of 6 weeks.
To ensure a long-term protection, a booster dose is recommended in the 2nd year of life.
Previously Unvaccinated Infants Between 6 and 12 months: 2 injections given with an interval of 1 month, followed by a booster in the 2nd year of life.
Previously Unvaccinated Children 1-5 years: 1 dose of vaccine.
As vaccination schemes vary from country to country, the schedule for each country may be used in accordance with the different national recommendations.
Administration: The reconstituted vaccine is for IM injection. However, it is good clinical practice that in patients with thrombocytopenia or bleeding disorders, the vaccine should be administered SC.
Instructions for Use, Handling: How to Use: The diluent and reconstituted vaccine should be inspected visually for any foreign particulate matter and/or variation of physical aspects prior to administration. In the event of either being observed, discard the diluent or reconstituted vaccine.
Hiberix must be reconstituted by adding the entire contents of the supplied container of diluent to the vial containing the powder. After the addition of the diluent to the powder, the mixture should be well shaken until the powder is completely dissolved in the diluent.
When using a multidose vial, each dose should be taken with a sterile needle and syringe. As with other vaccines, a dose of vaccine should be withdrawn under strict aseptic conditions and precautions taken to avoid contamination of the contents.
A new needle should be used to administer the vaccine.
After reconstitution, the vaccine should be injected promptly.
To Mix Hiberix with Tritanrix HB or Infanrix: Hiberix may be reconstituted either with Tritanrix HB or Infanrix for simultaneous administration via 1 injection.
Tritanrix HB and Infanrix are presented as suspensions. Upon storage, a white deposit and clear supernatant may be observed. The vaccine should be well shaken in order to obtain a homogeneous turbid white suspension and visually inspected for any foreign particulate matter and/or variation of physical aspect prior to administration. In the event of either being observed, discard the vaccine.
Discard the sterile diluent provided with Hiberix.
The combined DTPw-HB-Hib or DTPa-Hib vaccines must be reconstituted by adding the entire contents of either a Tritanrix HB or Infanrix monodose container to the monodose vial containing the white Hiberix powder. After the addition of Tritanrix HB or Infanrix to the Hiberix powder, the mixture should be well shaken until the Hiberix powder is completely dissolved in either the Tritanrix HB or Infanrix suspension.
The reconstituted combined vaccine should be inspected visually for any foreign particulate matter and/or variation of physical aspects prior to administration. In the event of either being observed, discard the reconstituted vaccine.
A new needle should be used to administer the vaccine. After reconstitution, the vaccine should be injected promptly.
Subjects with known hypersensitivity to any component of Hiberix, or having shown signs of hypersensitivity after previous administration of Hib vaccines.
As with other vaccines, the administration of Hiberix should be postponed in subjects suffering from acute severe febrile illness. The presence of a minor infection, however, is not a contraindication for vaccination. As with all injectable vaccines, appropriate medical treatment and supervision should always be readily available in case of a rare anaphylactic event following the administration of Hiberix. For this reason, the vaccinee should remain under medical supervision for 30 min after immunisation.
Human immunodeficiency virus (HIV) infection is not considered as a contraindication for Hiberix.
Although limited immune response to the tetanus toxoid component may occur, vaccination with Hiberix alone does not substitute for routine tetanus vaccination.
Excretion of capsular polysaccharide antigen in the urine has been described following receipt of Hib vaccines, and therefore antigen detection may not have a diagnostic value in suspected Hib disease within 1-2 weeks of vaccination.
Hiberix should under no circumstances be administered IV.
Syncope (fainting) can occur following, or even before, any vaccination as a psychogenic response to the needle injection. It is important that procedures are in place to avoid injury from faints.
Effects on the Ability to Drive or Operate Machinery: Not applicable.
Use in pregnancy & lactation: Adequate human data on use during pregnancy or lactation and adequate animal reproduction studies are not available.
Use in children: The potential risk of apnoea and the need for respiratory monitoring for 48-72 hrs should be considered when administering the primary immunization series to very premature infants (born ≤28 weeks of gestation) and particularly for those with a previous history of respiratory immaturity. As the benefit of vaccination is high in this group of infants, vaccination should not be withheld or delayed.
Adequate human data on use during pregnancy or lactation and adequate animal reproduction studies are not available.
Clinical Trial Data:
In controlled clinical studies, signs and symptoms were actively monitored and recorded on diary cards following the administration of the vaccine.
Of the local solicited symptoms, the most frequently reported within the first 48 hrs was mild redness at the injection site which resolved spontaneously. Other local solicited symptoms reported were mild swelling and pain at the injection site.
The general symptoms which have been solicited and reported within the first 48 hrs were mild and resolved spontaneously. These include fever, loss of appetite, restlessness, vomiting, diarrhoea and unusual crying. As for all Hib vaccines, these general symptoms have also been reported when administered concomitantly with other vaccines.
Undesirable effects reported are listed according to the following frequency: Very rare (<1/10,000).
Immune System Disorders: Very Rare:
Allergic reactions (including anaphylactic and anaphylactoid reactions), angioedema.
Nervous System Disorders: Very Rare:
Hypotonic-hyporesponsive episode, convulsion (with or without fever), syncope or vasovagal responses to injection, somnolence.
Respiratory, Thoracic and Mediastinal Disorders: Very Rare:
Apnoea (see Use in children under Precautions).
Skin and Subcutaneous Tissue Disorders: Very Rare:
General Disorders and Administration Site Conditions: Very Rare:
Extensive swelling of vaccinated limb, injection site induration.
Hiberix can be administered either simultaneously or at any time before or after a different inactivated or live vaccine.
As with other vaccines, it may be expected that in patients receiving immunosuppressive therapy or patients with immunodeficiency, an adequate response may not be achieved.
Incompatibilities: Hiberix can be mixed in the same syringe with Infanrix [diphtheria-tetanus-acellular pertussis (DTPa) vaccine] or Tritanrix HB [diphtheria-tetanus-whole cell pertussis and hepatitis B (DTPw-HB) vaccine]. Other injectable vaccines should always be administered at different injection sites.
The lyophilised vaccine has to be stored at +2°C to +8°C and has to be protected from light. It is not affected by freezing.
The diluent can be stored in the refrigerator (+2°C to +8°C) or at ambient temperatures (up to 25°C) and should not be frozen.
While recommended storage conditions should be respected, data have demonstrated that the vaccine remains stable under the following specific conditions: Lyophilised Product: Stored at 37°C for up to 24 months.
Reconstituted Product: Stored at 37°C for up to 24 hrs or at 21°C for up to 5 days.
J07AG - Haemophilus influenzae B vaccines ; Used for active immunizations.
Vial 0.5 mL (monodose, white powd) + vial or pre-filled syringe (sterile, clear, colourless diluent) x 1's.