Hiberix

Hiberix

Manufacturer:

GlaxoSmithKline

Distributor:

Zuellig
/
Agencia Lei Va Hong
Full Prescribing Info
Contents
Haemophilus influenzae type b (Hib) conjugate vaccine.
Description
After reconstitution, 1 dose (0.5 ml) contains: Haemophilus influenzae type b polysaccharide 10 micrograms, conjugated to tetanus toxoid as carrier protein approximately 25 micrograms.
Hiberix is a white powder.
The solvent is a clear and colourless liquid.
Excipients/Inactive Ingredients: Lyophilised Hib vaccine: Lactose.
Solvent: Sterile saline solution.
Action
Pharmaco-therapeutic group: Bacterial vaccines. ATC code: J07AG01.
Pharmacology: Pharmacodynamics: Pharmacodynamics Effects: Primary vaccination: Table 1 presents the immunogenicity results from 4 clinical trials in which infants in the United States, Europe, South America and South-East Asia received a 3-dose primary vaccination with Hiberix in the first 6 months of life starting from 6 weeks of age. Varying vaccination schedules were evaluated and Hiberix was co-administered with other routinely recommended vaccines.
Hiberix was immunogenic in all 3-dose schedules studied. Anti-PRP concentration of ≥ 0.15 μg/ml (a level indicative for short-term protection) was obtained in 96.6-99.4% of infants one month after the completion of the vaccination course. (See Table 1.)

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In addition, in unprimed toddlers aged 22-26 months (study Hib-036) who received a single dose of Hiberix co-administered with DTPa, 100% of subjects [N=54, 95 % CI (93.4;100)] achieved anti-PRP concentrations ≥ 1.0 μg/ml one month after vaccination. These data support a single dose of Hiberix in children aged from 1 year and above.
Booster vaccination: Antibody responses to booster vaccination with Hiberix after a 3 dose priming schedule are presented in Table 2. One month after the booster dose, all children had anti-PRP concentrations ≥ 0.15 μg/ml and at least 99.1% had anti-PRP concentrations ≥ 1.0 μg/ml, a concentration correlated with long term immunity to Hib (Table 2).

Click on icon to see table/diagram/image

Clinical Studies: See Pharmacodynamics as previously mentioned.
Pharmacokinetics: Evaluation of pharmacokinetic properties is not required for vaccines.
Toxicology: Pre-clinical Safety Data: Not applicable.
Indications/Uses
Hiberix is indicated for active immunisation of all infants from the age of 6 weeks against disease caused by Hib.
Hiberix does not protect against disease due to other types of H. influenzae nor against meningitis caused by other organisms.
Dosage/Direction for Use
Posology: The primary vaccination schedule consists of three 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 second year of life.
Infants between the ages of 6 and 12 months previously unvaccinated should receive 2 injections, given with an interval of one month, followed by a booster in the second year of life. Previously unvaccinated children aged 1-5 years should be given one 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.
Method of Administration: The reconstituted vaccine is for intramuscular injection. However, it is good clinical practice that in patients with thrombocytopenia or bleeding disorders the vaccine should be administered subcutaneously.
Overdosage
In general, the adverse event profile reported following overdosage was similar to that observed after administration of the recommended dose of Hiberix.
Contraindications
Hiberix should not be administered to subjects with known hypersensitivity to any component of the vaccine, or to subjects having shown signs of hypersensitivity after previous administration of Hib vaccines.
Special Precautions
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 contra-indication 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 the vaccine. For this reason the vaccinee should remain under medical supervision for 30 minutes after immunisation.
Human Immunodeficiency Virus (HIV) infection is not considered as a contra-indication 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 intravenously.
The potential risk of apnoea and the need for respiratory monitoring for 48-72h 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.
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.
Ability to perform tasks that require Judgement, Motor or Cognitive Skills: Not applicable.
Use In Pregnancy & Lactation
Pregnancy: As Hiberix is not intended for use in adults, human data on use during pregnancy and animal reproduction studies are not available.
Lactation: As Hiberix is not intended for us in adults, human data on use during lactation and animal reproduction studies are not available.
Adverse Reactions
Clinical Trial Data: The following frequencies were based on the analysis of approximately 3000 infants enrolled in study Hib-097 and of approximately 1200 infants enrolled in study DTPa-HBV-IPV-011.
Adverse reactions reported are listed according to the following frequency: Very common ≥ 1/10, Common ≥ 1/100 to < 1/10, Uncommon ≥ 1/1000 to < 1/100, Rare ≥ 1/10000 to < 1/1000, Very rare < 1/10000.
Metabolism and nutrition disorders: Very common: loss of appetite.
Psychiatric disorders: Very common: crying, irritability, restlessness.
Nervous system disorders: Very common: somnolence. Rare: convulsions (including febrile convulsions).
Gastrointestinal disorders: Very common: diarrhoea. Common: vomiting.
General disorders and administration site conditions: Very common: fever, swelling, pain and redness at the injection site.
Post Marketing Data: Immune system disorders: Very rare: allergic reactions (including anaphylactic and anaphylactoid reactions), angioedema.
Nervous system disorders: Very rare: hypotonic-hyporesponsive episode, syncope or vasovagal responses to injection.
Respiratory, thoracic and mediastinal disorders: Very rare: apnoea [see Precautions for apnoea in very premature infants (≤ 28 weeks of gestation)].
Skin and subcutaneous tissue disorders: Very rare: urticaria, rash.
General disorders and administration site conditions: Very rare: extensive swelling of vaccinated limb, injection site induration.
Drug Interactions
Hiberix can be administered either simultaneously or at any time before or after a different inactivated or live vaccine.
Hiberix can be mixed in the same syringe with GlaxoSmithKline vaccine Infanrix (DTPa vaccine). Other injectable vaccines should always be administered at different injection sites.
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.
Caution For Usage
Incompatibilities: Hiberix can be mixed in the same syringe with GlaxoSmithKline vaccine Infanrix (DTPa vaccine). Other injectable vaccines should always be administered at different injection sites.
Hiberix should not be mixed with other vaccines in the same syringe (except for authorised combinations).
Instructions for Use/Handling: The solvent and reconstituted vaccine should be inspected visually for any foreign particulate matter and/or variation of appearance prior to administration.
If either is observed, do not administer the vaccine.
Instructions for reconstitution of the vaccine with the solvent presented in pre-filled syringe: Hiberix must be reconstituted by adding the entire content of the pre-filled syringe of solvent to the vial containing the powder.
1. Holding the syringe barrel in one hand (avoid holding the syringe plunger), unscrew the syringe cap by twisting it anticlockwise.
2. To attach the needle to the syringe, twist the needle clockwise into the syringe until it locks.
3. Remove the needle protector, which on occasion can be a little stiff.
Add the solvent to the powder. After the addition of the solvent to the powder, the mixture should be well shaken until the powder is completely dissolved in the solvent.
The reconstituted vaccine is a clear to opalescent and colourless solution.
After reconstitution, the vaccine should be used promptly.
A new needle should be used to administer the vaccine.
Withdraw the entire contents of the vial.
As stated in Incompatibilities previously, Hiberix may be mixed with Infanrix monodose vaccine. In this case, the solvent supplied in the Hiberix package is replaced by the liquid Infanrix vaccine.
Make sure the container of the vaccine intended for mixing with Hiberix is a monodose container. From the Hiberix package, discard the container containing the solvent.
The combined vaccine must be reconstituted by adding the entire contents of the other vaccine container to the vial containing the Hib white powder.
This extemporaneously combined vaccine should be handled in the same way as the monocomponent reconstituted Hiberix vaccine.
Any unused product or waste material should be disposed of in accordance with local requirements.
Storage
The lyophilised vaccine has to be stored at +2°C to +8°C. The lyophilised vaccine is not affected by freezing.
The solvent can be stored in the refrigerator (at +2°C to +8°C) or at ambient temperatures (up to 25°C) and should not be frozen.
ATC Classification
J07AG01 - haemophilus influenzae B, purified antigen conjugated ; Belongs to the class of hemophilus influenzae B bacterial vaccines.
Presentation/Packing
Powd & solvent for soln for inj (pre-filled syringe) 0.5 mL x 1's + vial.
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