Diphtheria, Tetanus, Pertussis, Hepatitis B, and Poliovirus Vaccine (Systemic)

Brand Names : Pediarix

Before Receiving This Vaccine

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 DTaP-HepB-IPV vaccine, the following should be considered:

Allergies - Tell your doctor if you have ever had any unusual or allergic reaction to diphtheria toxoid, tetanus toxoid, pertussis vaccine, DTP vaccine, hepatitis B vaccine, or polio vaccine. Also tell your doctor and pharmacist if you are allergic to any other substances, such as thimerosal, neomycin, polymyxin B, yeast, or other preservatives.

Pregnancy - Adequate and well controlled studies in pregnant humans have not been done. DTaP-HepB-IPV should not be given to women of child bearing age. It is not known whether DTaP-HepB-IPV can cause harm to the fetus if given to a pregnant woman or if it can cause problems with the ability to have children. Make sure your doctor knows if you are pregnant or if you may become pregnant.

Breast-feeding - It is not known whether DTaP-HepB-IPV vaccine passes into breast milk. Mothers who get this vaccine and who are breast feeding should discuss this with your doctor

Children - Safety and effectiveness have not been established in children younger than six weeks of age. This vaccine is also not recommended for children over seven years of age.

Older adults - DTaP-HepB-IPV is not approved for use in older adults.

Other medicines - 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 health care professional if you are using any other prescription or nonprescription [OTC] medicine, especially:

• Anticoagulants (blood thinning medicines) - These medicines should not be given with the vaccine unless the potential benefit outweighs the risk

• Immunosuppressive medicines - These are medicines that decrease your immune response. Taking these with the vaccine may prevent your body from having a good response to the vaccine.

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

• Bleeding disorders (hemophilia or thrombocytopenia) - You may develop a formation of blood at the injection site. Your doctor should take steps to avoid this.

• Central nervous system disorders - If your child has certain disorders, you will need to look at the potential risks and benefits of getting DTaP-HepB-IPV. You should talk to your child's doctor to find out if your child should receive this vaccine.

• Disease of the brain - This includes coma, decreased level of consciousness, or seizures. People who have these symptoms within seven days of receiving a vaccine with pertussis in it should not get DTaP-HepB-IPV vaccine.

• Guillain-Barre syndrome - If you have ever had this condition after getting a vaccine with tetanus in it, you should weigh the potential benefits and possible risks of getting DTaP-HepB-IPV.

• Immunodeficiency disorder - If you have an immune system disorder, this vaccine may not work well for you

• Life threatening allergic reaction - You should not take this vaccine if you have had a severe allergic reaction to a previous dose of this vaccine or any ingredients in the vaccine. This includes polymyxin B, neomycin, and yeast.

• Moderate or severe illness, with or without fever - You should not get DTaP-HepB-IPV until the illness is gone and you feel better.

• Previous adverse reaction to this vaccine or any of its ingredients - If you have ever had an adverse reaction after getting a DTaP-HepB-IPV vaccine or another vaccine with pertussis in it, you should weigh the potential benefits and possible risks of getting DTaP-HepB-IPV. Adverse reactions include being unresponsive, crying continually without being able to stop for 3 hours or more, seizures with or without a fever, or a fever that is 105�F or higher.

• Progressive neurologic disorder - This includes infantile spasms, progressive brain disease, or uncontrolled epilepsy (seizures). DTaP-HepB-IPV should not be given until these conditions are treated and stabilized.

• Seizures, higher risk - Children at higher risk for seizures may be given a fever reducing medicine at the time the vaccine is given and for 24 hours after. By giving a fever reducing medicine, this may decrease the chance a fever may occur and cause a seizure.