ActHIB (haemophilus b conjugate vaccine (tetanus toxoid conjugate)) - Drug SummarySanofi Pasteur Inc.
ActHIB
(haemophilus b conjugate vaccine (tetanus toxoid conjugate))
THERAPEUTIC CLASS
Vaccine
DEA CLASS
RX
PEDIATRIC DOSAGE & INDICATIONS
Haemophilus influenza Type B
Prevention of Invasive Disease:
2 Months-5 Years:
0.5mL IM single dose
Administer as a 4-dose series; series consists of a primary 3-dose series of a single dose at 2, 4, and 6 months of age, followed by 1 booster dose at 15-18 months of age
ADMINISTRATION
IM route
Administer into the anterolateral aspect of the thigh or deltoid.
Do not mix in the same syringe w/ other parenteral products.
Reconstitution
- Reconstitute only w/ accompanying saline diluent.
- Withdraw 0.6mL of saline diluent from accompanying vial.
- Transfer 0.6mL saline diluent into lyophilized vaccine vial; agitate the vial thoroughly.
- Withdraw 0.5mL of reconstituted vaccine and administer.
Administer promptly after reconstitution or store at 2-8°C (35-46°F) and administer w/in 24 hrs; re-agitate stored vaccine before administration.
HOW SUPPLIED
Inj: 0.5mL
CONTRAINDICATIONS
Severe allergic reaction (eg, anaphylaxis) after a previous dose of any H. influenzae type b- or tetanus toxoid-containing vaccine or any component of the vaccine.
WARNINGS/PRECAUTIONS
Epinephrine and other appropriate agents must be available if an acute anaphylactic reaction occurs. eva luate potential benefits and risks if Guillain-Barre syndrome has occurred w/in 6 weeks of receipt of a prior tetanus toxoid-containing vaccine. Expected antibody responses may not be obtained if administered to immunosuppressed persons. May not protect all individuals. Does not substitute for routine tetanus immunization.
ADVERSE REACTIONS
Tenderness, fussiness/irritability, inconsolable crying, decreased activity/lethargy.
DRUG INTERACTIONS
Immunosuppressive therapies, including irradiation, antimetabolites, alkylating agents, cytotoxic drugs, and corticosteroids (used in greater than physiologic doses), may reduce immune response to vaccine.
PREGNANCY AND LACTATION
Pregnancy: Category C.
Lactation: Safety not known in nursing.
MECHANISM OF ACTION
Vaccine; produces antibody response to protect against H. influenzae type b.
ASSESSMENT
Assess for history of a severe allergic reaction to previous dose of any H. influenzae type b vaccination, tetanus toxoid-containing vaccine, or any component of the vaccine; history of Guillain-Barre syndrome w/in 6 weeks of receipt of a prior vaccine containing tetanus toxoid; immunosuppression; and for possible drug interactions. Review immunization history.
MONITORING
Monitor for allergic reactions, signs/symptoms of Guillain-Barre syndrome, inj-site reactions, and for any other possible adverse events. Monitor immune response.
PATIENT COUNSELING
Inform parents/guardians of the benefits and risks of vaccination, and of the importance of completing the immunization series. Instruct parents/guardians to report any serious adverse reactions to physician.
STORAGE
Lyophilized Vaccine Vial/After Reconstitution: 2-8°C (35-46°F). Do not freeze lyophilized vaccine. |
