Acthib
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Questions & Answers
Side Effects & Adverse Reactions
The stopper of the diluent vial contains natural rubber latex which may cause allergic reactions. The lyophilized vaccine vial is not made with natural rubber latex.
If ActHIB vaccine or ActHIB vaccine reconstituted with Tripedia vaccine (TriHIBit vaccine) is administered to immunosuppressed persons or persons receiving immunosuppressive therapy, the expected antibody responses may not be obtained. This includes patients with asymptomatic or symptomatic HIV infection (12), severe combined immunodeficiency, hypogammaglobulinemia, or agammaglobulinemia; altered immune states due to diseases such as leukemia, lymphoma, or generalized malignancy; or an immune system compromised by treatment with corticosteroids, alkylating drugs, antimetabolites, or radiation. (13) (Refer to product insert for Tripedia vaccine.)
Legal Issues
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FDA Safety Alerts
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Manufacturer Warnings
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FDA Labeling Changes
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Uses
ActHIB vaccine is indicated for the active immunization of infants and children 2 months through 5 years of age for the prevention of invasive disease caused by H influenzae type b.
TriHIBit vaccine, ActHIB vaccine combined with Tripedia vaccine by reconstitution, is indicated for the active immunization of children 15 through 18 months of age for prevention of invasive disease caused by H influenzae type b and diphtheria, tetanus and pertussis.
Vaccination with ActHIB vaccine reconstituted with saline diluent (0.4% Sodium Chloride) or Tripedia vaccine (TriHIBit vaccine) may not protect 100% of individuals.
History
There is currently no drug history available for this drug.
Other Information
ActHIB®, Haemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate), produced by Sanofi Pasteur SA, is a sterile, lyophilized powder which is reconstituted with either saline diluent (0.4% Sodium Chloride) or Tripedia®, Sanofi Pasteur Inc. Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed (DTaP) (when reconstituted known as TriHIBit®) for intramuscular administration only. The vaccine consists of the Haemophilus b capsular polysaccharide (polyribosyl-ribitol-phosphate, PRP), a high molecular weight polymer prepared from the Haemophilus influenzae type b (Hib) strain 1482 grown in a semi-synthetic medium, covalently bound to tetanus toxoid. (1) The lyophilized ActHIB vaccine powder and saline diluent contain no preservative. The tetanus toxoid is prepared by extraction, ammonium sulfate purification, and formalin inactivation of the toxin from cultures of Clostridium tetani (Harvard strain) grown in a modified Mueller and Miller medium. (2) The culture medium contains milk derived raw materials (casein derivatives). Further manufacturing process steps reduce residual formaldehyde to levels below 0.5 micrograms (mcg) per dose by calculation. The toxoid is filter sterilized prior to the conjugation process. Potency of ActHIB vaccine is specified on each lot by limits on the content of PRP polysaccharide and protein in each dose and the proportion of polysaccharide and protein in the vaccine which is characterized as high molecular weight conjugate.
When ActHIB is reconstituted with saline diluent (0.4% Sodium Chloride), each 0.5 mL dose is formulated to contain 10 mcg of purified capsular polysaccharide conjugated to 24 mcg of inactivated tetanus toxoid, and 8.5% of sucrose.
When ActHIB is reconstituted with Tripedia vaccine to formulate TriHIBit vaccine, each 0.5 mL dose contains 10 mcg of purified capsular polysaccharide conjugated to 24 mcg of inactivated tetanus toxoid, 8.5% of sucrose, 6.7 Lf of diphtheria toxoid, 5 Lf of tetanus toxoid, and 46.8 mcg of pertussis antigens. Tripedia vaccine (vial presentation 0.6 mL) is formulated without preservatives but contains a trace amount of thimerosal [(mercury derivative), (≤0.3 mcg mercury/dose)] from the manufacturing process. (Refer to product insert for Tripedia vaccine.)
Sources
Acthib Manufacturers
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Sanofi Pasteur Inc.
![Acthib (Haemophilus Influenzae Type B Strain 1482 Capsular Polysaccharide Tetanus Toxoid Conjugate Antigen) Kit [Sanofi Pasteur Inc.]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Acthib | Sanofi Pasteur Inc.
For intramuscular injection only
The ActHIB vaccine, reconstituted with saline diluent (0.4% Sodium Chloride), appears clear and colorless. TriHIBit vaccine, the reconstituted vaccine using Tripedia vaccine, is a homogenous white suspension.
Parenteral drug products should be inspected visually for particulate matter and/or discoloration prior to administration, whenever solution and container permit. If these conditions exist, the vaccine should not be administered.
RECONSTITUTIONActHIB is to be reconstituted only with the accompanying saline diluent (0.4% Sodium Chloride) or Tripedia vaccine to formulate TriHIBit vaccine. TriHIBit vaccine, ActHIB vaccine combined with Tripedia vaccine by reconstitution, should not be administered to infants younger than 15 months of age.
To prepare ActHIB vaccine, withdraw 0.6 mL of saline diluent (0.4% Sodium Chloride) and inject into the vial of lyophilized ActHIB vaccine. Agitate the vial to ensure complete reconstitution. The vaccine will appear clear and colorless. Withdraw a 0.5 mL dose of the reconstituted vaccine and inject intramuscularly. After reconstitution with saline diluent (0.4% Sodium Chloride), ActHIB vaccine should be administered promptly or stored refrigerated between 2° to 8°C (35° to 46°F) and administered within 24 hours. If the vaccine is not administered promptly, agitate the vial again before injection. Refer to Figures 1, 2, 3, 4, and 5.
To prepare TriHIBit vaccine, thoroughly agitate the vial of Sanofi Pasteur Inc. Tripedia vaccine then withdraw 0.6 mL and inject into the vial of lyophilized ActHIB vaccine. After reconstitution and thorough agitation, the combined vaccines will appear whitish in color. Withdraw a 0.5 mL dose of the combined vaccines and inject intramuscularly. TriHIBit vaccine (ActHIB reconstituted with Tripedia vaccine) should be administered within 30 minutes of reconstitution. Refer to Figures 1, 2, 3, 4, and 5.
Instructions for Reconstitution of ActHIB Vaccine with Saline Diluent (0.4% Sodium Chloride) or Tripedia Vaccine (TriHIBit Vaccine) Figure 1.
Agitate vial prior to disinfecting the vial stopper to avoid possible contamination. Figure 2.
Withdraw 0.6 mL of 0.4% Sodium Chloride or Tripedia vaccine as indicated. Figure 3.
Cleanse the ActHIB vaccine stopper, insert the syringe needle into the vial, and inject the total volume of diluent. Figure 4.
Agitate vial thoroughly. Figure 5.
After reconstitution, cleanse vial stopper. Using a new needle and syringe, withdraw 0.5 mL of reconstituted vaccine and administer intramuscularly.Before injection, the skin over the site to be injected should be cleansed with a suitable germicide.
Each dose of ActHIB vaccine reconstituted with saline diluent (0.4% Sodium Chloride) or Tripedia vaccine (TriHIBit vaccine) is administered intramuscularly in the outer aspect of the vastus lateralis (mid-thigh) or deltoid. The vaccine should not be injected into the gluteal area or areas where there may be a nerve trunk.
A 0.5 mL dose of ActHIB is approved for intramuscular administration in infants and children, 2 months through 5 years of age as a 4-dose series. The series consists of a primary immunization course of 3 doses administered at 2, 4, and 6 months of age, followed by one booster dose, administered at 15-18 months of age. The booster dose at 15-18 months of age may be given as TriHibit vaccine (ActHIB reconstituted with Tripedia).
For previously unvaccinated children, the number of doses of Haemophilus b Conjugate Vaccine needed depends on the age at which the immunization series is begun. A previously unvaccinated infant, 7 to 11 months of age, should receive as primary immunizations, two doses of Haemophilus b Conjugate Vaccine at 8-week intervals, followed by a booster dose at 15 to 18 months of age. A previously unvaccinated child 12 to 14 months of age should receive one dose of Haemophilus b Conjugate Vaccine followed by a booster dose at 15 to 18 months of age (doses to be separated by an interval of 8 weeks). A previously unvaccinated child 15 months through 5 years of age should receive one dose of ActHIB vaccine.
Preterm infants should be vaccinated according to their chronological age from birth. (19)
Interruption of the recommended schedule with a delay between doses should not interfere with the final immunity achieved with ActHIB vaccine reconstituted with saline diluent (0.4% Sodium Chloride) or with Tripedia vaccine (TriHIBit vaccine). There is no need to start the series over again, regardless of the time elapsed between doses.
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