DTaP "INFANRIX" FACTS


DTaP (Diphtheria, Tetanus and Pertussis) "INFANRIX" is made by the vaccine manufacturer GlaxoSmithKline. This vaccine is intended for ages 6 weeks - 7 years of age. (5 doses is recommended) Initial U.S approval: 1997


SYMPTOMS OF DTaP:

1. DIPHTHERIA - causes a thick covering in the back of the throat.

2. TETANUS (Lockjaw) - causes painful tightening of the muscles, usually all over the body.

3. PERTUSSIS (Whooping Cough) - causes coughing spells so bad that it is hard for infants to eat, drink, or breathe. 


TRANSMISSION:

1. DIPHTHERIA and PERTUSSIS - coughing or sneezing.

2. TETANUS - enters the body through cuts or wounds. 


INGREDIENTS:

1. Aluminum Hydroxide - (ANTACID)

2. Bovine Extract "BPE" - (FRESH PITUITARY GLANDS from CATTLE)

3. Formaldehyde - (GAS)

4. Glutaraldehyde - (PUNGENT)

5. 2-Phenoxyethanol - (GERMICIDE)

6. Polysorbate 80 - (SURFACTANT and EMULSIFIER)


YOU SHOULD NOT THIS VACCINATION IF:

1. Children who are moderately or severely ill

2. Any child who had a life-threatening allergic reaction after a dose of DTaP

3. Any child who suffered a brain or nervous system disease within 7 days after a dose of DTaP

4. Talk with your Doctor if your child experienced: Seizure, Collapsed, Cried non-stop 3 plus hours, Fever over 105°F 


CONTRAINDICATIONS:

1. Hypersensitivity Severe allergic reaction (e.g., anaphylaxis) after a previous dose of any diphtheria toxoid-, tetanus toxoid-, or pertussis-containing vaccine, or to any component of INFANRIX is a contraindication.

2. Progressive Neurologic Disorder, including infantile spasms, uncontrolled epilepsy, or progressive encephalopathy is a contraindication to administration of any pertussis-containing vaccine, including INFANRIX. 


WARNING:

1. Guillain-Barre syndrome occurs within 6 weeks of a prior vaccine containing tetanus toxoid, careful consideration should be given before administration

2. The tip caps of the prefilled syringes contain natural rubber latex which may cause allergic reactions.

3. Syncope (fainting) can occur and be accompanied by transient neurological signs: visual disturbance, paresthesia, and tonic-colonic limb movements.

4. If any of the following events occur careful consideration of potential benefits and risks should be considered * Temperature of 105 F * Collapse or shock-like state (hypotonic-hyporesponsive episode) * Persistent, inconsolable crying lasting 3 hours or more * Seizures with or without fever

5. For children at higher risk of seizures, an appropriate antipyretic may be administered at the time of vaccination

6. Apnea following intramuscular vaccination has been observed in some infants born prematurely.

7. The healthcare provider should review the patient’s immunization history for possible vaccine hypersensitivity.

* 8. Sufficient data are NOT available on the Safety and Effectiveness of interchanging INFANRIX and Diphtheria and Tetanus Toxoids and Acellular Pertussis (DTaP) vaccines from different manufacturers

9. It is also NOT known whether INFANRIX can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity

10. INFANRIX has not been evaluated for carcinogenic (CANCER) or mutagenic (DNA MUTATION) potential, or for impairment of fertility (INFERTILITY)

11. Protection against pertussis in children administered 3 doses of INFANRIX in infancy was sustained to 6 years of age.