ADACEL PRESCRIBING INFORMATION PDF
“We are pleased the FDA has expanded the age indication for Adacel vaccine, For more information about Adacel vaccine, please see the full Prescribing. Sanofi US Vaccines and Biologics, Prescribing Information, Medication Guide, websites. Adacel® Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular. Adacel® is a vaccine indicated for active booster immunization against tetanus, For indications, dosing and other information, please refer to the prescribing.
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The use of Adacel vaccine as a primary series or to complete the primary series for tetanus, diphtheria, or pertussis has not been studied. Subscribe to receive email notifications whenever new articles are published.
Information regarding adverse events that occurred in the 6 month post-vaccination time period was obtained from the participant via telephone. The following adverse events were included based on severity, frequency of reporting or the strength of causal association to Adacel vaccine.
The rate of severe pain 0. Solicited local and systemic reactions and rpescribing adverse events were monitored daily for 14 days post-vaccination using a diary card. Body Ache or Muscle Weakness. Separate injection sites and separate syringes must be used in case of concomitant administration. See Table 1 precsribing Table 2.
Adacel TDAP – FDA prescribing information, side effects and uses
In the concomitant vaccination study with Adacel and Hepatitis B vaccines see Clinical Studies for description of study design and number of participantslocal and systemic adverse events were monitored daily for 14 days post-vaccination using a diary card.
The frequency of other solicited adverse events Days are presented in Table 6. Injection Site Pain Any Most joint complaints were mild in intensity with a mean duration of 2. Animals were administered Adacel vaccine twice prior to gestation, during the period of organogenesis gestation day 6 and later during pregnancy on gestation day 29, 0.
A total of 4, randomized participants were vaccinated. Adacel vaccine can be used as a one-time alternative to Tetanus and Diphtheria Toxoids Adsorbed for Adult Use Td vaccine in patients for whom the pertussis component is also indicated.
From day 14 to the end of the trial, i. The toxin causes neuromuscular dysfunction, with rigidity and spasms of skeletal muscles. Persistent nodules at the site of injection have been reported following the use of adsorbed products.
Epinephrine Hydrochloride Solution 1: Toxigenic strains are more often associated with severe or fatal respiratory infections than with cutaneous infections. Rates of moderate and severe pain in adolescents did not significantly differ between the Adacel vaccine and Td vaccine groups.
Medically reviewed on Jun 1, The cut-off values for pertussis prescribinv were established based on antibody data from both adolescents and adults in previous clinical trials.
The preferred site is into the deltoid muscle. From days 28 informayion 6 months post-vaccination, participants were monitored for unexpected visits to a physician’s office or to an emergency room, onset of serious illness and hospitalizations. The systemic intoxication is caused by diphtheria exotoxin, an extracellular protein metabolite of toxigenic strains of C diphtheriae.
Such reactions may be associated with high levels of circulating antitoxin in persons who have had overly frequent injections of tetanus toxoid.
Other neurological conditions that have been reported include: Sdacel following adverse events have been spontaneously reported during the post-marketing use of Adacel vaccine in the US and other countries. In all the studies, participants were monitored for serious adverse events throughout the duration of the study.
Immunosuppressive therapies, including irradiation, antimetabolites, alkylating agents, cytotoxic drugs and corticosteroids used in greater than physiologic dosesmay reduce the immune response to vaccines.
Headache was the most frequent systemic reaction and was usually of mild to moderate intensity. Local and systemic solicited reactions occurred at similar rates in Adacel vaccine and Td vaccine recipients in the 3 day post-vaccination period. A total of 5, individuals years informarion age inclusive 3, adolescents years of age and 2, adults years received a single dose of Adacel vaccine. Complete immunization significantly reduces the risk of developing diphtheria and immunized persons who develop disease have milder illness.
If Adacel vaccine is administered to immunocompromised persons, including persons receiving immunosupressive therapy, the expected immune response may not be obtained. Arthus-type hypersensitivity reactions, characterized by severe local reactions generally starting hours after an injectionmay follow receipt of tetanus toxoid.
No studies have been performed with Adacel vaccine to evaluate carcinogenicity, mutagenic potential, or impairment of fertility. An additional 1, adolescents received Adacel vaccine prescgibing part of the lot consistency study used to support Adacel vaccine licensure.
Females of child-bearing potential should be informed that Sanofi Pasteur Inc.