Daptacel

This vaccine is given only to infants and children 6 weeks to 7 years of age (before the child`s 7th birthday) .

Diphtheria is a serious illness that can cause breathing difficulties, heart problems, nerve damage, pneumonia, and possibly death. The risk of serious complications and death is greater in very young children and in the elderly .

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

Pertussis (also known as whooping cough) is a serious disease that causes severe spells of coughing that can interfere with breathing. Pertussis also can cause pneumonia, long-lasting bronchitis, seizures, brain damage, and death .

Diphtheria, tetanus, and pertussis are serious diseases that can cause life-threatening illnesses. Although some serious side effects can occur after a dose of DTaP (usually from the pertussis vaccine part), this rarely happens. The chance of your child catching one of these diseases, and being permanently injured or dying as a result, is much greater than the chance of your child getting a serious side effect from the DTaP vaccine .

This vaccine is to be administered only by or under the supervision of your child`s doctor or other health care professional .

This product is available in the following dosage forms:

• Suspension

Before Using

In deciding to use a vaccine, the risks of taking the vaccine must be weighed against the good it will do. This is a decision you and your doctor will make. For this vaccine, the following should be considered:

Allergies

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

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of diphtheria, tetanus, and acellular pertussis vaccine in infants younger than 6 weeks of age and in children 7 years of age and older . Safety and efficacy have not been established .

Geriatric

Diphtheria, tetanus, and acellular pertussis vaccine is not recommended for use in adult populations .

Pregnancy

Breastfeeding

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

Drug Interactions

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Other Interactions

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

Other Medical Problems

The presence of other medical problems may affect the use of this vaccine . Make sure you tell your doctor if you have any other medical problems, especially:

• Allergic reaction to a previous dose of DTaP or


• Brain disease (decreased level of consciousness, uncontrolled seizures) or


• Fevera€”Use of DTaP may make these conditions worse or may increase the chance of side effects .

• Bleeding disorders (hemophilia, thrombocytopenia)a€”Should not use in patients with this condition .

• Epilepsy (seizures or convulsions), history of or


• Guillain-BarrA© syndrome (inflammatory disorder that causes paralysis), history of or


• Nervous system disordera€”Your doctor will decide if you should receive this vaccine .

• Weakened immune systema€”This vaccine may not work as well in patients with this condition .

Proper Use

A nurse or other trained health professional will give your child this vaccine . This 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. It is important that your child receive all of the shots in this series. Try to keep all scheduled appointments. If your child must miss a shot, make another appointment with the child`s doctor as soon as possible .

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 .

Precautions

It is very important that the doctor check your child at regular visits to make sure this vaccine is working properly and to check for unwanted effects. It is very important that you return to your child`s doctor for the next dose in the series .

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

Be sure to tell your child`s doctor about any side effects that occur after your child receives the vaccine . This may include fainting, seizures, fever, crying that will not stop, or severe redness or swelling where the shot was given .

Side Effects

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

Check with your doctor 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 A°F


• Redness or swelling of 4 inches or more at the injection site


• Seizures (convulsions)


• Severe pain at the injection site

Incidence not known

• Agitation


• Back pain


• Black, tarry stools


• Bleeding gums


• Bleeding, blistering, burning, coldness, discoloration of skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at injection site


• Blood in the urine or stools


• Bloody nose


• Bluish color of fingernails, lips, skin, palms, or nail beds


• Blurred vision


• Confusion


• Cough


• Diarrhea


• Difficulty 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


• Mood or mental changes


• Muscle pain or weakness


• Nausea and vomiting


• Pain or cramping in abdomen


• Pinpoint red spots on 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


• Shortness of breath


• Sleepiness or unusual drowsiness


• Sneezing


• Sore throat


• Stiff neck


• Swollen, painful, or tender lymph glands in the neck, armpit, or groin


• Tightness in the chest


• Total body jerking


• Troubled breathing or swallowing


• Unusual bleeding or bruising


• Unusual tiredness or weakness (sudden and severe)


• Wheezing

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 A°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.