Uses
What the official label says Td vaccine (tetanus and diphtheria) is used for
The Td vaccine protects against tetanus and diphtheria. The label provided here is for one Td vaccine product, given as an injection.
The label says it is used for active immunization to prevent tetanus and diphtheria in people 7 years of age and older.
Read the label's “Indications and usage” section (verbatim)
TENIVAC ® is a vaccine indicated for active immunization for the prevention of tetanus and diphtheria in persons 7 years of age and older. TENIVAC is a vaccine indicated for active immunization for the prevention of tetanus and diphtheria in persons 7 years of age and older. ( 1 )
Names & forms
Brand names, forms and strengths
Brand names (from RxNorm; not every brand is still sold): Tenivac.
Generic name: tetanus toxoid and diphtheria toxoid · RxNorm ID (RxCUI): 1190911
| Form | Strengths listed in RxNorm |
|---|---|
| Injection | — |
| Prefilled Syringe | — |
Strengths are listed so you can recognise a product — not as dosing information. Only your prescriber can decide what is right for you.
Read the label's “Dosage forms and strengths” section (verbatim)
TENIVAC is an injectable suspension. A single dose is 0.5 mL. Injectable suspension. Each dose is 0.5 mL. ( 3 )
Appearance
What Td vaccine (tetanus and diphtheria) looks like
| Strength | Form | Colour | Shape | Size | Imprint | Score | Labeler |
|---|---|---|---|---|---|---|---|
| clostridium tetani toxoid antigen (formaldehyde inactivated) 5 [Lf] per 0.5 mL / corynebacterium diphtheriae toxoid antigen (formaldehyde inactivated) 2 [Lf] per 0.5 mL | injection, suspension | white“WHITE CLOUDY” | — | — | — | — | Sanofi Vaccines US Inc. |
From the product data in each manufacturer's label on DailyMed. Many companies make Td vaccine (tetanus and diphtheria), so your medicine may look different from any shown here. If a pill looks unfamiliar, ask your pharmacist before taking it.
Read the label's “How supplied” section (verbatim)
Single-dose Vial, NDC No. 49281-215-58; in package of 10 vials, NDC No. 49281-215-10. Contains no latex. Single-dose Syringe, NDC No. 49281-215-88; in package of 10 syringes, NDC No. 49281-215-15. The tip caps of the prefilled syringes may contain natural rubber latex. No other components contain latex. TENIVAC should be stored at 2° to 8°C (35° to 46°F). DO NOT FREEZE. Product which has been exposed to freezing should not be used. Do not use after expiration date shown on the label.
Safety
Important warnings for Td vaccine (tetanus and diphtheria)
In plain English, the label's key warnings include:
- The label says the tip caps of the prefilled syringes may contain natural rubber latex, which may cause allergic reactions in people sensitive to latex.
- Getting the vaccine more often than the label describes may lead to more frequent and more severe side effects. People who had an Arthus-type reaction (a severe local reaction) after a past tetanus vaccine should not get it again sooner than the label allows, even for wound care.
- A review found evidence of a link between tetanus toxoid and both Guillain-Barré syndrome and brachial neuritis (nerve inflammation in the arm). The label says benefits and risks should be weighed carefully for people who had Guillain-Barré syndrome soon after a past tetanus vaccine.
- Fainting can happen after injectable vaccines. The vaccine may not protect everyone, and people with weakened immune systems may have a lower response.
Contraindications — who should not use it (verbatim)
Severe allergic reaction (e.g., anaphylaxis) to a previous dose of TENIVAC, or any other tetanus or diphtheria toxoid-containing vaccine, or any component of this vaccine. ( 4.1 ) 4.1 Hypersensitivity A severe allergic reaction (e.g., anaphylaxis) after a previous dose of TENIVAC or any other tetanus toxoid or diphtheria toxoid-containing vaccine or any other component of this vaccine is a contraindication to administration of TENIVAC. [ see Description (11) .] 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.
Warnings and precautions (verbatim excerpt)
The tip caps of the prefilled syringes may contain natural rubber latex which may cause allergic reactions in latex sensitive individuals. ( 5.2 ) More frequent administration of TENIVAC than described in Dosage and Administration ( 2.1 , 2.2 , 2.3 , 2.4 ) may be associated with increased incidence and severity of adverse reactions. ( 5.3 ) Persons who experienced an Arthus-type hypersensitivity reaction following a prior dose of a tetanus toxoid-containing vaccine should not receive TENIVAC more frequently than every 10 years, even for tetanus prophylaxis as part of wound management. ( 5.4 ) Carefully consider benefits and risks before administering TENIVAC to persons with a history of Guillain-Barré syndrome within 6 weeks of a previous tetanus toxoid-containing vaccine. ( 5.5 ) Syncope (fainting) can occur in association with administration of injectable vaccines, including, TENIVAC. Procedures should be in place to avoid injury from fainting. ( 5.8 ) 5.1 Management of Acute Allergic Reactions Appropriate medical treatment must be immediately available to manage potential anaphylactic reactions following administration of TENIVAC. 5.2 Latex The tip caps of the TENIVAC prefilled syringes may contain natural rubber latex, which may cause allergic reactions in latex sensitive individuals. 5.3 Frequency of Administration More frequent doses of TENIVAC than described in Section 2, Dosage and Administration, may be associated with increased incidence and severity of adverse reactions. [ see Dosage and Administration (2.1 , 2.2 , 2.3 , 2.4) .] 5.4 Arthus 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 TENIVAC more frequently than every 10 years, even for tetanus prophylaxis as part of wound management. 5.5 Guillain-Barré Syndrome and Brachial Neuritis A review by the Institute of Medicine found evidence for a causal relation between tetanus toxoid and both brachial neuritis and Guillain-Barré syndrome. ( 2 ) If Guillain-Barré syndrome occurred within 6 weeks of receipt of prior vaccine containing tetanus toxoid, the decision to give TENIVAC or any vaccine containing tetanus toxoid should be based on careful consideration of the potential benefits and possible risks. 5.6 Limitations of Vaccine Effectiveness Vaccination with TENIVAC may not protect all individuals. 5.7 Altered Immunocompetence If TENIVAC is administered to immunocompromised persons, including persons receiving immunosuppressive therapy, the expected immune response may not be obtained. Immunosuppressive therapies, including irradiation, antimetabolites, alkylating agents, cytotoxic drugs and corticosteroids (used in greater than physiologic doses), may reduce the immune response to TENIVAC. 5.8 Syncope Syncope (fainting) can occur in association with administration of injectable vaccine, including TENIVAC. Procedures should be in place to avoid injury from fainting.
Side effects — opening of the label's adverse reactions section
The most frequent solicited injection site reaction within 0-3 days following TENIVAC was pain, reported in 78.3% of study participants 11-59 years of age and 35.3% of participants ≥60 years of age. ( 6.1 ) The most frequent solicited systemic reaction within 0-3 days following TENIVAC was headache, reported in 17.9% of participants, overall. ( 6.1 ) Other common (≥10%) solicited adverse reactions within 0-3 days following TENIVAC were injection site redness, injection site swelling, malaise, muscle weakness and pain in joints. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Sanofi Vaccines US Inc. …
This is not a complete list of warnings or side effects. Read the full label and talk to your prescriber or pharmacist. To report a side effect to the FDA, use MedWatch.
Resources
If you were hurt at work
Whether a medicine is right for you is a decision for your prescriber. If you were injured on the job, these educational guides explain the next steps and who can help.
- Injured at work? →What to do after a workplace injury and how workers' comp generally works.
- Prescription home delivery →How mail-order pharmacies can deliver prescriptions to your door.
- Find help →Connect with workers' comp attorneys and doctors who take work-injury cases.
- Pharmacies near you →Search local pharmacies by ZIP code.