Infanrix

DRUG DESCRIPTION

INFANRIX (Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed) is a noninfectious, sterile combination of diphtheria and tetanus toxoids and 3 pertussis antigens [inactivated pertussis toxin (PT) and formaldehyde-treated filamentous hemagglutinin (FHA) and pertactin (69 kiloDalton outer membrane protein)] adsorbed onto aluminum hydroxide. INFANRIX (diphtheria and tetanus toxoids and acellular pertussis) is intended for intramuscular injection only.

The diphtheria toxin is produced by growing Corynebacterium diphtheriae in Fenton medium containing a bovine extract. Tetanus toxin is produced by growing Clostridium tetani in a modified Latham medium derived from bovine casein. The bovine materials used in these extracts are sourced from countries which the United States Department of Agriculture (USDA) has determined neither have nor are at risk of bovine spongiform encephalopathy (BSE). Both toxins are detoxified with formaldehyde, concentrated by ultrafiltration, and purified by precipitation, dialysis, and sterile filtration.

The 3 acellular pertussis antigens (PT, FHA, and pertactin) are isolated from Bordetella pertussis culture grown in modified Stainer-Scholte liquid medium. PT and FHA are isolated from the fermentation broth; pertactin is extracted from the cells by heat treatment and flocculation. The antigens are purified in successive chromatographic and precipitation steps. PT is detoxified using glutaraldehyde and formaldehyde. FHA and pertactin are treated with formaldehyde.

Each antigen is individually adsorbed onto aluminum hydroxide. Each 0.5-mL dose is formulated to contain 25 Lf of diphtheria toxoid, 10 Lf of tetanus toxoid, 25 mcg of inactivated PT, 25 mcg of FHA, and 8 mcg of pertactin.

Diphtheria and tetanus toxoid potency is determined by measuring the amount of neutralizing antitoxin in previously immunized guinea pigs. The potency of the acellular pertussis components (inactivated PT and formaldehyde-treated FHA and pertactin) is determined by enzyme-linked immunosorbent assay (ELISA) on sera from previously immunized mice.

Each 0.5-mL dose also contains 4.5 mg of NaCl, and aluminum adjuvant (not more than 0.625 mg aluminum by assay). Each dose also contains ? 100 mcg of residual formaldehyde and ? 100 mcg of polysorbate 80 (Tween 80). INFANRIX (diphtheria and tetanus toxoids and acellular pertussis) is formulated without preservatives.

The vaccine must be well shaken before administration to obtain a homogeneous, turbid, white suspension.

Diphtheria and Tetanus Toxoids Adsorbed Combined Bulk (For Further Manufacturing Use) is manufactured by Novartis Vaccines and Diagnostics GmbH & Co. KG, Marburg, Germany. The acellular pertussis antigens are manufactured by GlaxoSmithKline Biologicals, Rixensart, Belgium. Formulation, filling, testing, packaging, and release of the vaccine are performed by GlaxoSmithKline Biologicals.

What are the possible side effects of diphtheria, tetanus, acellular pertussis vaccine (Daptacel (DTaP), Infanrix (DTaP), Infanrix (DTaP) Preservative Free, Tripedia (DTaP))?

Your child should not receive a booster vaccine if he or she had a life-threatening allergic reaction after the first shot.

Keep track of any and all side effects your child has after receiving this vaccine. When the child receives another diphtheria, tetanus, acellular pertussis vaccine in the future, you will need to tell the child's doctor if the first shot caused any side effects.

Becoming infected with diphtheria,...

Read All Potential Side Effects and See Pictures of Infanrix


Infanrix Patient Information Including Side Effects

Brand Names: Daptacel (DTaP), Infanrix (DTaP), Infanrix (DTaP) Preservative Free, Tripedia (DTaP)

Generic Name: diphtheria, tetanus, acellular pertussis vaccine (DTaP) (Pronunciation: dif THEER ee uh, TET a nus, ay SEL yoo ler per TUS iss)

  • What is diphtheria, tetanus, acellular pertussis vaccine (Infanrix)?
  • What are the possible side effects of diphtheria, tetanus, acellular pertussis vaccine (Infanrix)?
  • What is the most important information I should know about diphtheria, tetanus, acellular pertussis vaccine (Infanrix)?
  • What should I discuss with my healthcare provider before receiving this vaccine (Infanrix)?
  • How is this vaccine given (Infanrix)?
  • What happens if I miss a dose (Infanrix)?
  • What happens if I overdose (Infanrix)?
  • What should I avoid before or after receiving this vaccine (Infanrix)?
  • What other drugs will affect diphtheria, tetanus, acellular pertussis vaccine (Infanrix)?
  • Where can I get more information?

What is diphtheria, tetanus, acellular pertussis vaccine (Infanrix)?

Diphtheria, tetanus, and pertussis are serious diseases caused by bacteria.

Diphtheria causes a thick coating in the nose, throat, and airways. It can lead to breathing problems, paralysis, heart failure, or death.

Pertussis (whooping cough) causes coughing so severe that it interferes with eating, drinking, or breathing. These spells can last for weeks and can lead to pneumonia, seizures (convulsions), brain damage, and death.

Tetanus (lockjaw) causes painful tightening of the muscles, usually all over the body. It can lead to "locking" of the jaw so the victim cannot open the mouth or swallow. Tetanus leads to death in about 1 out of 10 cases.

Diphtheria and pertussis are spread from person to person. Tetanus enters the body through a cut or wound.

The diphtheria, tetanus acellular, and pertussis pediatric vaccine (also called DTaP) is used to help prevent these diseases in children who are ages 6 weeks to 6 years old (before the child has reached his or her 7th birthday).

This vaccine works by exposing your child to a small dose of the bacteria or a protein from the bacteria, which causes the body to develop immunity to the disease. This vaccine will not treat an active infection that has already developed in the body.

Like any vaccine, the DTaP vaccine may not provide protection from disease in every person.

What are the possible side effects of diphtheria, tetanus, acellular pertussis vaccine (Infanrix)?

Your child should not receive a booster vaccine if he or she had a life-threatening allergic reaction after the first shot.

Keep track of any and all side effects your child has after receiving this vaccine. When the child receives another diphtheria, tetanus, acellular pertussis vaccine in the future, you will need to tell the child's doctor if the first shot caused any side effects.

Becoming infected with diphtheria, pertussis, or tetanus is much more dangerous to your child's health than receiving the vaccine to protect against these diseases. Like any medicine, this vaccine can cause side effects, but the risk of serious side effects is extremely low.

Get emergency medical help if your child has any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if the child has any of these serious side effects:

  • extreme drowsiness, fainting;
  • fussiness, irritability, crying for an hour or longer;
  • seizure (black-out or convulsions); or
  • high fever.

Less serious side effects include:

  • mild fever or chills;
  • redness, pain, tenderness, or swelling where the shot was given;
  • mild fussiness or crying;
  • joint pain, body aches;
  • loss of appetite; or
  • mild nausea, diarrhea, or vomiting.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report vaccine side effects to the US Department of Health and Human Services at 1-800-822-7967.

What is the most important information I should know about diphtheria, tetanus, acellular pertussis vaccine (Infanrix)?

This vaccine is given in a series of shots. The first shot is usually given when the child is 2 months old. The booster shots are then given at 4 months, 6 months, 15 months, and 18 months of age, and again between 4 and 6 years of age. Your child's individual booster schedule may be different from these guidelines. Follow your doctor's instructions or the schedule recommended by your local health department.

Be sure your child receives all doses of this vaccine recommended by your healthcare provider or by the health department of the state you live in. If the child does not receive the full series of vaccines, he or she may not be fully protected against the disease.

Your child can still receive a vaccine if he or she has a cold or fever. In the case of a more severe illness with a fever or any type of infection, wait until the child gets better before receiving this vaccine.

Your child should not receive a booster vaccine if he or she had a life-threatening allergic reaction after the first shot.

Keep track of any and all side effects your child has after receiving this vaccine. When the child receives a booster dose, you will need to tell the doctor if the previous shots caused any side effects.

Becoming infected with diphtheria, pertussis, or tetanus is much more dangerous to your child's health than receiving the vaccine to protect against these diseases. Like any medicine, this vaccine can cause side effects, but the risk of serious side effects is extremely low.

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