ADACEL PACKAGE INSERT PDF
ADACEL is an adult/adolescent formulation diphtheria-tetanus-acellular encephalopathy) has resulted from the administration of any vaccine product. Adacel (Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis . Parenteral drug products should be inspected visually for particulate matter and. Package Insert ADACEL®, [Tetanus Toxoid, Reduced Diphtheria Toxoid and Adsorbed vaccine or ADACEL®, with or without passive.
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Medically reviewed on Jun 1, After shaking, the vaccine is a white, homogenous, cloudy suspension. Other ingredients per dose include 1. The acellular pertussis vaccine components are obtained from Bordetella pertussis cultures grown in Stainer-Scholte medium 1 modified by the addition of casamino acids and dimethyl-beta-cyclodextrin.
FIM are extracted and co-purified from the bacterial cells. The pertussis antigens are purified by sequential filtration, salt-precipitation, ultrafiltration and chromatography. PT is detoxified with glutaraldehyde, FHA is treated with formaldehyde, and the residual aldehydes are removed by ultrafiltration.
The individual antigens are adsorbed onto aluminum phosphate.
Adacel | Immunisation Advisory Centre
Corynebacterium diphtheriae is grown in modified Mueller’s growth medium. Clostridium tetani is grown in modified Mueller-Miller casamino acid medium without beef heart infusion.
Diphtheria and tetanus toxoids are individually adsorbed onto aluminum phosphate. The adsorbed diphtheria, tetanus and acellular pertussis components are combined with aluminum phosphate as adjuvant2-phenoxyethanol not as a preservative and water for injection.
Tetanus and diphtheria toxoid potency is determined by measuring the amount of neutralizing antitoxin in previously immunized guinea pigs.
Tetanus is an afacel and often fatal disease caused by an extremely potent neurotoxin produced by C tetani. The toxin causes neuromuscular dysfunction, with rigidity and spasms of skeletal muscles. The muscle spasms usually involve the jaw lockjaw and neck and then become generalized. packaage
Spores of C tetani are ubiquitous. Serological tests indicate that naturally acquired immunity to tetanus toxin does not occur in the US. Thus, universal primary immunization, with subsequent maintenance of adequate antitoxin levels insertt means of appropriately timed boosters, is necessary to protect all age groups.
Following immunization, protection generally persists for at least 10 years.
C diphtheriae may cause both localized and generalized disease. The systemic intoxication is caused by diphtheria exotoxin, an extracellular protein metabolite of toxigenic strains of C diphtheriae. Both toxigenic and nontoxigenic strains of C diphtheriae can cause disease, but only strains that produce toxin can cause severe manifestations such as myocarditis and neuritis.
Toxigenic strains are more often associated with severe or fatal respiratory infections than with cutaneous infections.
Complete immunization significantly reduces the risk of developing diphtheria and immunized persons who packabe disease have milder illness. Immunization with diphtheria toxoid does not, however, eliminate carriage of C diphtheriae in the pharynx, nose, or on the skin.
Following immunization, protection lasts at least 10 years. Pertussis whooping cough is a disease of the respiratory tract, most often caused by B pertussis. This gram-negative coccobacillus produces a variety of biologically active components, though their role in pathogenesis is not clearly defined. Protection against disease attributable to C tetani is due to the development of neutralizing antiboides to tetanus toxin.
A serum antitoxin level of 0. Antitoxin levels of at least 0. The mechanism of protection from B pertussis disease is not well understood. Adacep, the pertussis components in Adacel vaccine i. The efficacy of the tetanus toxoid and diphtheria toxoid used in Adacel vaccine was based on the immune response to these antigens compared to a US licensed Tetanus and Diphtheria Toxoids Adsorbed For Adult Use Td vaccine manufactured by Sanofi Pasteur Inc. The primary measures of immunogenicity were a the percentage of participants attaining an antibody level of at least 0.
The demonstration of a booster response depended on the insertt concentration to each antigen prior to immunization. Threshold or “cut-off” values for antibody concentrations to each antigen were established based on the 95 th percentile of the pre-vaccination antibody concentrations observed inesrt previous clinical trials.
A booster response was defined as a four-fold rise in antibody concentration if the pre-vaccination concentration was equal to or below the cut-off value and a two-fold rise in antibody concentration if the pre-vaccination concentration was above the avacel value.
The efficacy of the pertussis antigens used in Adacel vaccine was inferred based on a comparison of pertussis antibody levels achieved in recipients of a single booster dose of Adacel vaccine with those obtained in infants after three doses of DAPTACEL vaccine.
The protective efficacy against mild pertussis defined as at least one day of cough with laboratory-confirmed B pertussis infection was The principal immunogenicity study was a packafe, multi-center, randomized, observer-blind, controlled trial which enrolled 4, participants; 2, adolescents years of age and 2, adults years of age.
Enrollment was stratified by age to ensure adequate representation across the entire age range. Participants had not received a tetanus or diphtheria toxoid containing vaccine within the previous 5 years.
After enrollment participants were randomized to receive one dose of either Adacel vaccine or Td vaccine. A total of 4, randomized participants were vaccinated. The per-protocol immunogenicity subset included 1, Adacel vaccine recipients and 1, Td vaccine recipients. Sera were obtained before and approximately 35 days after vaccination.
Demographic characteristics were similar within age groups and between the vaccine groups. See Table 1 and Table 2. Acceptable booster responses to each of the pertussis antigens were also demonstrated, i.
The second dose of Hep B vaccine was given weeks after the first dose.
Serum samples were obtained prior to and weeks after Adacel vaccine administration, as well as weeks after the 2 nd dose of Hep B for all participants. No interference was observed in the immune responses to any of the vaccine antigens when Adacel and Hep B vaccines were given concurrently or separately. Sera were obtained prior to and weeks after Adacel vaccine, as well as weeks after the TIV. Adacel vaccine is indicated for active booster immunization for the prevention of tetanus, diphtheria and pertussis as a single dose in persons 11 through 64 years of age.
The use of Adacel vaccine as a primary series, or to complete the primary series, has not been studied. A severe allergic reaction e. Because of uncertainty as to which component of the vaccine may be responsible, none of the components should be administered. Alternatively, such individuals may be referred to an allergist for evaluation if further immunizations are to be considered.
Encephalopathy within 7 days of a previous dose of a pertussis containing vaccine not attributable to another identifiable cause is a contraindication to vaccination with Adacel vaccine. Persons who experienced Arthus-type hypersensitivity reactions e. Before administration of Adacel vaccine, the patient’s current health status and medical history should be reviewed in order to determine whether any contraindications exist and to assess the benefits and risks of vaccination.
Administering Diphtheria, Tetanus, and Pertussis Vaccines
Epinephrine Hydrochloride Solution 1: If Adacel vaccine is administered to immunocompromised persons, including persons receiving immunosupressive therapy, the expected immune response may not be obtained. Females of child-bearing potential should be informed that Sanofi Pasteur Inc.
If they are pregnant or become aware they were pregnant at the time of Adacel vaccine immunization, they are encouraged to contact directly or have their health-care professional contact Sanofi Pasteur Inc.
Immunosuppressive therapies, including irradiation, antimetabolites, alkylating agents, cytotoxic pxckage and corticosteroids used in greater than physiologic dosesmay reduce the immune response to vaccines.
No studies have been performed with Adacel vaccine to evaluate carcinogenicity, mutagenic potential, or impairment of fertility. Animal reproduction studies have not been conducted with Adacel vaccine.
It is also not known whether Adacel vaccine can cause fetal harm when administered to a pregnant woman or can affect adacep capacity. Adacel vaccine should be given to a pregnant woman only if clearly needed. Animal fertility studies have not been conducted with Adacel vaccine. The effect of Adacel vaccine on embryo-fetal and pre-weaning development was evaluated in two developmental toxicity studies using pregnant rabbits.
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. No adverse effects on pregnancy, parturition, lactation, embryo-fetal or pre-weaning development were observed. There were no vaccine related fetal malformations or other adacwl of teratogenesis noted in this study.
It is not known whether Adacel vaccine is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Adacel vaccine is given to a nursing woman. Adacel vaccine is not indicated for individuals less than 11 years of age. For immunization of persons 6 weeks through 6 years of age against diphtheria, tetanus and pertussis refer to manufacturers’ package inserts for DTaP vaccines.
TGA eBS – Product and Consumer Medicine Information
Adacel vaccine is not indicated for individuals 65 years of age and older. No data are available regarding the safety and effectiveness of Adacel vaccine in individuals 65 years of age and older as clinical studies of Adacel vaccine did not include participants in the geriatric population. The safety of Adacel vaccine was evaluated in 4 clinical studies. A total of 5, individuals years of age inclusive 3, adolescents years of age and 2, adults years received a single dose of Adacel vaccine.
Study participants had not received tetanus or diphtheria containing vaccines within the previous 5 years. Solicited local and systemic reactions and unsolicited adverse events were monitored daily for 14 days post-vaccination using a diary card. From days post-vaccination, information on adverse events necessitating a medical contact, such as a telephone call, visit to an emergency room, physician’s office or hospitalization, was obtained via telephone interview or at an interim clinic visit.
From days 28 to 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.
Information regarding adverse events that occurred in the 6 month post-vaccination time period was obtained from the participant via telephone. 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.
Unsolicited reactions including immediate reactions, serious adverse events and events that elicited seeking medical attention were collected at a clinic visit or via telephone interview for the duration of the trial, i. In the concomitant vaccination study with Adacel vaccine and trivalent inactivated influenza vaccine see Clinical Studies for description of study design and number of participantslocal and systemic adverse events were monitored for 14 days post-vaccination using a diary card.
All unsolicited reactions occurring through day 14 were collected. From day 14 to the end of the trial, i. In all the studies, participants were monitored for serious adverse events throughout the duration of the study. Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a vaccine cannot be directly compared to rates in the clinical trials of another vaccine and may not reflect the rates observed in practice.
The adverse reaction information from clinical trials does, however, provide a basis for identifying the adverse events that appear to be related to vaccine use and for approximating rates of those events.
Throughout the 6-month follow-up period in the principal safety study, serious adverse events were reported in 1.