Tetanus and Diphtheria Toxoids Adsorbed (Td): patient information, prescribing information, ingredients, manufacturer, adverse reactions and side effects

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use TETANUS AND DIPHTHERIA TOXOIDS ADSORBED safely and effectively. See full prescribing information for TETANUS AND DIPHTHERIA TOXOIDS ADSORBED.

See full insert sheet at this link at the Natural News Reference website.

TETANUS AND DIPHTHERIA TOXOIDS ADSORBED

Suspension for Intramuscular Injection

Initial US Approval:

INGREDIENTS AND EXCIPIENTS

Tetanus and Diphtheria Toxoids Adsorbed (Td) manufactured by MassBiologics is a sterile vaccine for intramuscular injection. After shaking, the vaccine appears as a homogeneous milky white suspension.

Each 0.5 ml dose of MassBiologics’ Td is formulated to contain the following active ingredients: 2 Lf of tetanus toxoid and 2 Lf of diphtheria toxoid. Each 0.5 ml dose also contains aluminum adjuvant (not more than 0.53 mg aluminum by assay), < 100 mcg (0.02%) of residual formaldehyde, and a trace amount of thimerosal [mercury derivative, (< 0.3 mcg mercury/dose)] (not as a preservative) from the manufacturing process.

The Corynebacterium diphtheriae and Clostridium tetani organisms are grown on modified Mueller’s media^{1, 2} which contains bovine extracts. The bovine material used in these extracts is sourced from countries which the United States Department of Agriculture has determined neither have nor present an undue risk for bovine spongiform encephalopathy. Tetanus and diphtheria toxins produced during growth of the cultures are detoxified with formaldehyde. The detoxified materials are then separately purified by ammonium sulfate fractionation. The diphtheria toxoid is further purified by column chromatography. The tetanus and diphtheria toxoids are individually adsorbed onto aluminum phosphate.

The tetanus and diphtheria toxoids induce at least 2 units and 1 unit of antitoxin per ml of serum, respectively, in the guinea pig potency test.

INDICATIONS AND USAGE

MassBiologics’ Td is a vaccine indicated for active immunization for the prevention of tetanus and diphtheria. This vaccine is approved for use in persons 7 years of age and older.

DOSAGE AND ADMINISTRATION

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.

DOSAGE FORMS AND STRENGTHS

– The stopper of the vial is latex free.

– MassBiologics’ Td is supplied in single-dose (0.5 ml) vials.

CONTRAINDICATIONS

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.

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.

WARNINGS AND PRECAUTIONS

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.

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.

ADVERSE REACTIONS

General Disorders and Administration Site Conditions: Injection site reactions, including pain, tenderness, erythema, induration, pruritis, swelling and warmth; peripheral oedema, pyrexia, malaise

Nervous System Disorders: Dizziness, headache, convulsions

Musculoskeletal and Connective Tissue Disorders: Myalgia, musculoskeletal stiffness or pain, arthralgia

Skin and Subcutaneous Tissue Disorders: Rash

Gastrointestinal Disorders: Nausea Infections and Infestations: Cellulitis

DRUG INTERACTIONS

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.

USE IN SPECIFIC POPULATIONS

PREGNANCY

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.

NURSING MOTHERS

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.

PEDIATRIC USE

MassBiologics’ Td is not approved for use in infants and children younger than 7 years of age. The safety and effectiveness of MassBiologics’ Td in this age group have not been established.

GERIATRIC USE

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.

Revised:

https://www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedProducts/UCM164127.pdf

http://naturalnewsreference.com/vaccine-insert-sheets/Tetanus-Diphtheria-Toxoids-Adsorbed.pdf