Haemophilus b conjugate vaccine indications and usage: Difference between revisions
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==Indications And Usage== | |||
<ref name="dailymed.nlm.nih.gov">{{Cite web | last = | first = | title = HIBERIX (HAEMOPHILUS B CONJUGATE VACCINE (TETANUS TOXOID CONJUGATE)) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [GLAXOSMITHKLINE BIOLOGICALS SA] | url = http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=745ff8df-1618-4b76-9aa1-6f42752c0dda | publisher = | date = | accessdate = }}</ref> | HIBERIX® is indicated for active immunization as a booster dose for the prevention of invasive disease caused by Haemophilusinfluenzae type b. HIBERIX is approved for use in children 15 months through 4 years of age (prior to fifth birthday). | ||
HIBERIX is to be used as a booster dose in children who have received a primary series with a Haemophilus b Conjugate Vaccine that is licensed for primary immunization. HIBERIX is not approved for primary immunization. | |||
The evaluation of effectiveness of HIBERIX as a booster dose was based on immune responses in children using serological endpoints that predict protection from invasive disease due to H. influenzae type b [see Clinical Pharmacology and Clinical Studies ]. These protective antibody levels have not been evaluated in clinical trials in which a booster dose of HIBERIX is compared to a booster dose of a US-licensed Haemophilus b Conjugate Vaccine in children who previously received a primary series with a US-licensed Haemophilus b Conjugate Vaccine [see Clinical Studies ].<ref name="dailymed.nlm.nih.gov">{{Cite web | last = | first = | title = HIBERIX (HAEMOPHILUS B CONJUGATE VACCINE (TETANUS TOXOID CONJUGATE)) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [GLAXOSMITHKLINE BIOLOGICALS SA] | url = http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=745ff8df-1618-4b76-9aa1-6f42752c0dda | publisher = | date = | accessdate = }}</ref> | |||
Latest revision as of 14:43, 9 January 2014
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Chetan Lokhande, M.B.B.S [2]
Indications And Usage
HIBERIX® is indicated for active immunization as a booster dose for the prevention of invasive disease caused by Haemophilusinfluenzae type b. HIBERIX is approved for use in children 15 months through 4 years of age (prior to fifth birthday).
HIBERIX is to be used as a booster dose in children who have received a primary series with a Haemophilus b Conjugate Vaccine that is licensed for primary immunization. HIBERIX is not approved for primary immunization.
The evaluation of effectiveness of HIBERIX as a booster dose was based on immune responses in children using serological endpoints that predict protection from invasive disease due to H. influenzae type b [see Clinical Pharmacology and Clinical Studies ]. These protective antibody levels have not been evaluated in clinical trials in which a booster dose of HIBERIX is compared to a booster dose of a US-licensed Haemophilus b Conjugate Vaccine in children who previously received a primary series with a US-licensed Haemophilus b Conjugate Vaccine [see Clinical Studies ].[1]
References
Adapted from the FDA Package Insert.