TE Anatoxal Berna (Intramuscular, Injection)

Tetanus Toxoid is used to prevent tetanus (also known as lockjaw). Tetanus is a serious illness that can cause convulsions (seizures) and severe muscle spasms, which can be strong enough to break bones in the spine. Tetanus can lead to death in 30 to 40 percent of cases.

Immunization against tetanus is recommended for all infants aged 6 to 8 weeks and older, all children, and all adults. Immunization against tetanus starts with a series of either 3 or 4 injections, depending on which type of tetanus toxoid you receive. It is also very important to get a booster injection every 10 years for the rest of your life. If you suffer a wound that is unclean or difficult to clean, you may need an emergency booster injection if it has been more than 5 years since your last booster. In recent years, two-thirds of all tetanus cases have been in people aged 50 and older. Having a tetanus infection in the past does not make you immune to tetanus in the future.

This vaccine is to be given only by or under the supervision of your doctor or other health care professional.

In deciding to use a medicine, you should consider the risks of taking it compared to the benefits. This decision will be made between you and your doctor. For this medicine, you should think about the following:

In deciding to receive this vaccine, consider the risks of getting it against the benefits. This is a decision you and your doctor will make. For tetanus toxoid, think about the following:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also inform your healthcare professional about any other allergies you have, such as to foods, dyes, preservatives, or animals. For non-prescription products, carefully read the label or package ingredients.

Pediatric

Use is not recommended for infants up to 6 weeks of age. For infants and children 6 weeks of age and older, tetanus toxoid is not expected to cause different side effects or problems than it does in adults.

Geriatric

This vaccine is not expected to cause different side effects or problems in older people than it does in younger adults. However, the vaccine may be slightly less effective in older persons than in younger adults.

Breast Feeding

There are no adequate studies in women to determine the risk to infants when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Some medicines should not be used together at all, while in other cases, two different medicines may be used together even if an interaction might occur. In these situations, your doctor may want to adjust the dose, or other precautions may be necessary. It is especially important that your healthcare professional knows if you are taking any of the medicines listed below when you are using this medicine. The following interactions have been selected based on their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be necessary in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both medicines.

• Cyclosporine

Using this medicine with any of the following medicines may increase the risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both medicines.

• Chloramphenicol

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or certain types of food since interactions may happen. Using alcohol or tobacco with certain medicines may also lead to interactions. Discuss with your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical problems may affect the use of this medicine. Make sure to tell your doctor if you have any other medical issues, especially:

• A severe reaction or a fever greater than 103 °F (39.4 °C) after a previous dose of tetanus toxoid—This may increase the chance of side effects with future doses of tetanus toxoid; be sure your doctor knows about this before you receive the next dose of tetanus toxoid

• Bronchitis, pneumonia, or other illnesses affecting the lungs or bronchial tubes, or
• Severe illness with fever—Possible side effects from tetanus toxoid may be confused with the symptoms of the condition

Along with its needed effects, a medicine may cause some unwanted effects. Not all of these side effects may occur, but if they do, they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Symptoms of allergic reaction

• Difficulty in breathing or swallowing
• hives
• itching, especially of feet or hands
• reddening of skin, especially around ears
• swelling of eyes, face, or inside of nose
• unusual tiredness or weakness (sudden and severe)

Check with your doctor as soon as possible if any of the following side effects occur:

Rare

• Confusion
• convulsions (seizures)
• fever over 103 °F (39.4 °C)
• headache (severe or continuing)
• sleepiness (excessive)
• swelling, blistering, or pain at place of injection (severe or continuing)
• swelling of glands in armpit
• unusual irritability
• vomiting (severe or continuing)

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Your health care professional may also provide ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Redness or hard lump at place of injection

Less common

• Chills, fever, irritability, or unusual tiredness
• pain, tenderness, itching, or swelling at place of injection
• skin rash

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

In the U.S.

• TE Anatoxal Berna

In Canada

• Tetanus Toxoid Adsorbed

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For injection dosage forms: For prevention of tetanus (lockjaw): Adults, children, and infants 6 weeks of age and older—One dose is given at your first visit, then a second dose is given four to eight weeks later. Depending on the product given, you may receive a third dose four to eight weeks after the second dose, and a fourth dose six to twelve months after that; or you may receive a third dose six to twelve months after the second dose. Everyone should receive a booster dose every ten years. The doses are injected under the skin or into a muscle. In addition, if you get a wound that is unclean or hard to clean, you may need an emergency booster injection if it has been more than 5 years since your last booster dose.