|Dosage Form||Package Information||Links|
|INJECTION||.5 mL in 1 VIAL, SINGLE-DOSE (21695-413-01)||Label Information|
A severe allergic reaction (e.g., anaphylaxis) occurring after a previous dose of this vaccine, or any other tetanus or diphtheria toxoid-containing vaccine, or any component of this vaccine is a contraindication to administration of MassBiologics' Td vaccine. (See DESCRIPTION). Because of the uncertainty as to which component of the vaccine might be responsible, no further vaccination with diphtheria or tetanus components should be carried out. Alternatively, such individuals may be referred to an allergist for evaluation if further immunizations are to be considered.
FREQUENCY OF ADMINISTRATION
More frequent administration of MassBiologics' Td than described in DOSAGE AND ADMINISTRATION may be associated with an increased incidence and severity of adverse reactions.
Persons who experienced an Arthus-type hypersensitivity reaction following a prior dose of a tetanus toxoid-containing vaccine usually have high serum tetanus antitoxin levels and should not receive MassBiologics' Td more frequently than every 10 years, even for tetanus prophylaxis as part of wound management. (See DOSAGE AND ADMINISTRATION).
A review by the Institute of Medicine found evidence for a causal relation between tetanus toxoid and Guillain-Barré Syndrome.9 If Guillain-Barré Syndrome occurred within 6 weeks after receipt of a previous dose of tetanus toxoid-containing vaccine, the decision to give subsequent doses of MassBiologics' Td or any vaccine containing tetanus toxoid should be based on careful consideration of the potential benefits and possible risks.10
Vaccination with MassBiologics' Td may not protect all individuals.
Epinepherine injection (1:1000) and other appropriate agents and equipment must be immediately available should an acute anaphylactic reaction occur.
Prior to the administration of MassBiologics' Td, the vaccine recipient's current health status and health history should be reviewed. This includes a review of the immunization history of the patient, the presence of any contraindications to immunization, and any adverse events after previous immunizations to allow an assessment of the benefits and risks of vaccination. (See CONTRAINDICATIONS and WARNINGS).
If MassBiologics' Td is administered to immunocompromised persons (whether from disease or treatment) the expected immune response may not be obtained.
INFORMATION FOR PATIENTS
Prior to administration of MassBiologics' Td, patients, parents or guardians should be informed by the health care provider of the benefits and risks of immunization with Td and of the importance of completing the primary immunization series or receiving recommended booster doses.
The health care provider should inform the patient, parent, or guardian of the potential for adverse reactions that have been temporally associated with MassBiologics' Td or other vaccines containing similar ingredients. Patients, parents or guardians should be instructed to report any suspected adverse reactions to their health care provider.
According to the National Childhood Vaccine Injury Act of 1986, Vaccine Information Statements must be provided by the health care provider with each vaccine dose administered.
Patients who are on immunosuppressive therapy, including alkylating agents, antimetabolites, cytotoxic drugs, irradiation, or corticosteroids (used in greater than physiologic doses), may have a reduced immune response to vaccines.
No safety and immunogenicity data are available on the concomitant administration of MassBiologics' Td vaccine with other U.S. licensed vaccines.
CARCINOGENESIS, MUTAGENESIS, IMPAIRMENT OF FERTILITY
No studies have been performed with MassBiologics' Td to evaluate carcinogenicity, mutagenic potential or impairment of fertility.
PREGNANCY CATEGORY C
Animal reproduction studies have not been conducted with MassBiologics' Td. It is also not known whether MassBiologics' Td can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. MassBiologics' Td should be given to a pregnant woman only if clearly needed.
It is not known whether MassBiologics' Td is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when MassBiologics' Td is administered to a nursing woman.
MassBiologics' Td is not approved for use in infants and children younger then 7 years of age. The safety and effectiveness of MassBiologics' Td in this age group have not been established.
No studies have been performed with MassBiologics' Td in adults aged 65 years and older in order to determine whether they respond differently than younger subjects.
MassBiologics' Td may be used in persons 7 years of age and older who have not been previously immunized against tetanus and diphtheria, as a primary immunization series consisting of three 0.5 ml doses. The first two doses are administered 4-8 weeks apart and the third dose is administered 6-12 months after the second dose.
MassBiologics' Td may be used to complete the primary immunization series for tetanus and diphtheria, following one or two doses of Diphtheria and Tetanus Toxoids and Pertussis Vaccine Adsorbed (whole-cell DTP), Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed (DTaP) and/or Diphtheria and Tetanus Toxoids Adsorbed (DT) vaccine. However, the safety and efficacy of MassBiologics' Td in such regimens have not been evaluated.
ROUTINE BOOSTER IMMUNIZATIONMassBiologics' Td may be used for routine booster immunization against tetanus and diphtheria in persons 7 years of age and older who have completed primary immunization against tetanus and diphtheria. Routine booster immunization against tetanus and dipthheria is recommended in children 11-12 years of age and every 10 years thereafter. 10
The Advisory Committee on Immunization Practices (ACIP) has specific recommendations on booster immunization against tetanus and diphtheria for adolescents and adults.10, 13, 14
TETANUS PROPHYLAXIS IN WOUND MANAGEMENT
For active tetanus immunization in wound management of patients 7 years of age and older, a preparation containing tetanus and diphtheria toxoids is preferred instead of single-antigen tetanus toxoid to enhance diphtheria protection.15 MassBiologics' Td is approved for wound management of patient 7 years of age and older.
The need for active immunization with a tetanus toxoid-containing preparation, with or without Tetanus Immune Globulin (TIG) (Human) depends on both the condition of the wound and the patient's vaccination history (Table 1).When indicated, TIG (Human) should be administered using a separate needle and syringe at a different anatomic site, according to the manufacturer's package insert. If a contraindication to using a tetanus toxoid-containing vaccine exists in a person who has not completed tetanus primary immunization and other than a clean, minor wound is sustained, only passive immunization with TIG (Human) should be given. 15
TABLE 1 GUIDE TO TETANUS PROPHYLAXIS IN ROUTINE WOUND MANAGEMENT IN PERSONS AGED 7 YEARS AND OLDER13, 14, 15
| History of Adsorbed Tetanus
|Clean, Minor Wounds||All Other Wounds*|
|| Td â€
| Unknown or < 3
|TETANUS AND DIPHTHERIA TOXOIDS ADSORBED
tetanus and diphtheria toxoids adsorbed injection
|Labeler - Rebel Distributors (118802834)|
|Rebel Distributors||118802834||relabel, repack|