Infanrix (Intramuscular)

Diphtheria, tetanus, and acellular pertussis vaccine (also known as DTaP) is a combination shot given to protect against infections from diphtheria, tetanus (lockjaw), and pertussis (whooping cough). This vaccine is given only to children 6 weeks through 6 years of age (before the child's 7th birthday).

Diphtheria is a serious illness that can lead to breathing problems, heart issues, nerve damage, pneumonia, and possibly death. The risk of severe complications and death is higher in very young children and in older adults.

Tetanus (also known as lockjaw) is a serious illness that can cause convulsions (seizures) and severe muscle spasms that may be strong enough to cause spine fractures. Tetanus can lead to death in 30 to 40 percent of cases.

Pertussis (also known as whooping cough) is a serious disease that causes severe coughing spells that can make it hard to breathe. Pertussis can also lead to pneumonia, long-lasting bronchitis, seizures, brain damage, and death.

Diphtheria, tetanus, and pertussis are serious diseases that can lead to life-threatening conditions. While some serious side effects can happen after receiving a dose of DTaP (usually due to the pertussis part), this is rare. The chance of your child getting one of these diseases and suffering permanent injury or death is much higher than the chance of your child experiencing a serious side effect from the DTaP vaccine.

This vaccine should be given only by or under the direct supervision of your doctor.

It is very important for the doctor to check your child at regular visits to ensure this vaccine is working properly and to monitor for any unwanted effects. It is crucial that you return to your child's doctor for the next dose in the series.

Contact your doctor immediately if your child experiences sudden weakness in the arms and legs. This could indicate a serious condition called Guillain-Barré syndrome.

It is very important to inform the doctor if your child is allergic to rubber. The Tripedia® vial and syringes may contain dry natural latex rubber, which may cause an allergic reaction if your child has a latex allergy.

This vaccine will not treat an active infection. If your child has an infection caused by diphtheria, tetanus, or pertussis, your child will need medication to treat these infections.

Fainting may happen after receiving this vaccine. You may also experience vision changes, numbness or tingling in your arms, hands, or feet, or jerky movements of the arms and legs. Call the doctor right away if you or your child has any of these symptoms.

Make sure to inform your child's doctor about any side effects that occur after your child receives the vaccine. This may include seizures, fever, persistent crying, or severe redness or swelling at the injection site.

This vaccine may cause apnea (breathing stops for short periods) in some premature infants. Discuss this with your child's doctor if you have concerns.

Do not take any other medicines unless you have discussed them with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

In deciding to use a vaccine, you need to consider the risks of the vaccine against the benefits it provides. This is a decision you will make with your doctor. For this vaccine, keep the following in mind:

Allergies

Inform your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also, let your healthcare professional know if you have other types of allergies, such as to foods, dyes, preservatives, or animals. When using non-prescription products, read the label or package ingredients carefully.

Pediatric

There have not been appropriate studies on how diphtheria, tetanus, and acellular pertussis vaccine affects children younger than 6 weeks of age and children 7 years of age and older. Safety and effectiveness have not been established.

Geriatric

Diphtheria, tetanus, and acellular pertussis vaccine is not recommended for adults.

There is no information available on how Daptacel® affects older patients.

Breast Feeding

There are no adequate studies in women to determine if there is any risk to infants when using this medication while breastfeeding. Consider the potential benefits and risks before taking this medication while breastfeeding.

Interactions with Medicines

Some medicines should never be used together, while others can be used together even if there may be an interaction. In these situations, your doctor may adjust the dose or take other precautions. When receiving this vaccine, it is very important for your healthcare professional to know if you are taking any of the medicines listed below. The following interactions are based on their potential significance and are not a complete list.

It is usually not recommended to receive this vaccine with any of the following medicines, but it may be necessary in some cases. If both medicines are prescribed together, your doctor may adjust the dose or frequency of one or both medicines.

• Elivaldogene Autotemcel
• Teplizumab-mzwv
• Ublituximab-xiiy

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be taken at or around the time of eating food or certain types of food due to possible interactions. Using alcohol or tobacco with some medicines may also cause interactions. Talk to 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 vaccine. Be sure to tell your doctor if you have any other medical issues, especially:

• Bleeding disorders (e.g., hemophilia, thrombocytopenia)—This vaccine should not be used in patients with this condition.

• Brain disease (e.g., encephalopathy)—This includes coma, decreased consciousness, or long-lasting seizures. Children who experience these symptoms within 7 days of receiving a vaccine with pertussis should not receive this vaccine.

• Guillain-Barré syndrome (nerve disorder with paralysis), history of—If your child had this condition after receiving a vaccine containing tetanus toxoid, discuss with your doctor the potential benefits and risks of getting this vaccine.

• Immunodeficiency disorder or
• Weakened immune system—This vaccine may not be as effective in children with this condition.

• Previous serious reaction to a vaccine—If your child experienced a serious reaction to this vaccine or another vaccine with pertussis, discuss with your doctor the potential benefits and risks of getting this vaccine. Serious reactions can include being less responsive than usual, crying continuously for 3 hours or more, having a seizure with or without fever, or having a fever of 105 degrees F or higher.

• Progressive neurologic disorder—This includes infantile spasms, progressive brain disease, or uncontrolled seizures. This vaccine should not be given until these conditions are treated and under control.

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 or nurse immediately if any of the following side effects occur:

Less common

• Collapse or shock-like state
• Crying for 3 hours or more
• Fever over 102.2 °F
• Redness or swelling of 4 inches or more at the injection site
• Seizures
• Severe pain at the injection site

Incidence not known

• Agitation
• Back pain
• Black, tarry stools
• Bleeding gums
• Bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site
• Blood in the urine or stools
• Bloody nose
• Bluish color of the fingernails, lips, skin, palms, or nail beds
• Blurred vision
• Chest tightness
• Confusion
• Cough
• Diarrhea
• Difficulty with swallowing
• Dizziness
• Drowsiness
• Fast heartbeat
• Hallucinations
• Headache
• Hoarseness
• Irritability
• Irritation
• Joint pain, stiffness, or swelling
• Loss of bladder control
• Loss of consciousness
• Loss of strength or energy
• Muscle pain or weakness
• Nausea and vomiting
• Pain or cramping in the abdomen or stomach
• Pinpoint red spots on the skin
• Puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• Rash with flat lesions or small raised lesions on the skin
• Screaming
• Sleepiness or unusual drowsiness
• Sneezing
• Sore throat
• Stiff neck
• Swollen, painful, or tender lymph glands in the neck, armpit, or groin
• Total body jerking
• Trouble breathing
• Unusual bleeding or bruising
• Unusual tiredness or weakness (sudden and severe)

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. Also, your health care professional may be able to tell you about 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

• Fever of 99.5 °F or more
• Fussiness
• Loss of appetite
• Mild pain, redness, swelling, or tenderness at the injection site
• Restlessness
• Weight loss

Incidence not known

• Crying
• Ear pain

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.

• Daptacel
• Infanrix
• Tripedia

Available Dosage Forms:

• Suspension

Therapeutic Class: Vaccine

A nurse or other trained health professional will give your child this vaccine. The vaccine is given as a shot into one of your child's muscles.

This vaccine is usually given as a series of 4 or 5 shots. Your child may receive the first 3 doses of Infanrix® at 2, 4, and 6 months of age. 2 booster doses will be given at 15 to 20 months of age and 4 to 6 years of age.

It is important that you or your child receive all of the shots. Try to keep all scheduled appointments. Make another appointment as soon as possible if you or your child misses a dose of this vaccine.

Your child may receive other vaccines at the same time as this one, but in a different body area. You should receive information sheets about all of the vaccines your child receives. Make sure you understand all of the information that is given to you.

Your child may also receive a medicine to help prevent or treat some of the minor side effects of the vaccine, like fever and soreness.

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