Certiva

DRUG DESCRIPTION

Certiva (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed) TM (Diphtheria and Tetanus sterile combination of diphtheria, Toxoids and Acellular Pertussis Vaccine Adsorbed) is a tetanus, and pertussis toxoids (one pertussis antigen, inactivated pertussis toxin), adsorbed onto aluminum hydroxide.1 It is intended for intramuscular injection only. After shaking, Certiva (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed) TM is a homogeneous white suspension. The pertussis toxin (PT) is isolated from Phase 1 Boraktella pertussis grown in modified Stainer-Scholte medium. After purification by afIinity chromatography, which includes the use of fetuin, a bovine serum protein, as an aflinity ligand, PT is detoxified using hydrogen peroxide.

Diphtheria toxin is derived from Corynebacterium diphtheriae grown in Stainers Diphtheria Culture Medium, containing casein hydrolysate, and is purified by fractional precipitation with ammonium sulfate. Tetanus toxin is derived from Clostridium tetani grown in modified Mueller and Miller Medium, containing casein hydrolysate, and is purified by precipitation with ammonium sulfate.2 The purified diphtheria and tetanus toxins are detoxified using formaldehyde.

Each antigen is individually adsorbed onto aluminum hydroxide. 2 Each 0.5 ml dose of vaccine is formulated to contain 15 Lf diphtheria toxoid, 6 Lf tetanus toxoid, 40 mcg pertussis toxoid, 0.5 mg aluminum as aluminum hydroxide, and is preserved with 0.01% thimerosal (mercury derivative). The product may contain residual fetuin. The residual free formaldehyde content by assay is less than or equal to 10 ppm. The diphtheria and tetanus toxoids each induce not less than 2 units of antitoxin per ml in the guinea pig potency test. The potency of the pertussis toxoid is evaluated by measurement of antibody titers to pertussis toxin in immunized mice using an ELISA.

Diphtheria and tetanus toxoid bulks for further manufacturing use are produced by Statens Seruminstitut, Copenhagen, Denmark. The pertussis toxoid is manufactured by North American Vaccine, Inc., Beltsville, Maryland. Final formulation and release of Certiva (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed) TM are conducted by North American Vaccine, Inc.

What are the possible side effects of diphtheria, tetanus, and pertussis vaccines (Acel-Imune, Certiva, Daptacel, Infanrix, Tripedia)?

Keep track of any and all side effects your child has after receiving this vaccine. When the child receives the next booster dose, you will need to tell the doctor if the first shot caused any side effects. Getting diphtheria, tetanus, or pertussis disease is much riskier than getting DTaP vaccine. However, like any medicine, this vaccine, can cause side effects. The risk of DTaP vaccine causing a serious side effect is extremely small.

Get emergency medical help if you...

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Certiva Patient Information Including Side Effects

Brand Names: Acel-Imune, Certiva, Daptacel, Infanrix, Tripedia

Generic Name: diphtheria, tetanus, and pertussis (DTaP) vaccines (Pronunciation: DIF thee ree ah, TET ah nus, per TUH sis)

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

What are diphtheria, tetanus, and pertussis vaccines (Certiva)?

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

Diphtheria causes a thick coating in the nose, throat, and airway. It can lead to breathing problems, paralysis, heart failure, and even 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 his mouth or swallow. Tetanus leads to death in about 1 out of 10 cases.

Pertussis (whooping cough) causes coughing so severe that it is hard for infants to eat, drink, or breathe. These spells can last for weeks. It can lead to pneumonia, seizures (convulsions), brain damage, and death.

Diphtheria and pertussis are spread from person to person. Tetanus enters the body through cuts or wounds. Vaccines for these diseases expose the individual to a small amount of the bacteria, helping the body develop immunity to the disease.

Diphtheria, tetanus, and pertussis vaccine (DTaP) can help prevent these diseases. Most children who are vaccinated with DTaP will be protected throughout childhood.

What are the possible side effects of diphtheria, tetanus, and pertussis vaccines (Certiva)?

Keep track of any and all side effects your child has after receiving this vaccine. When the child receives the next booster dose, you will need to tell the doctor if the first shot caused any side effects. Getting diphtheria, tetanus, or pertussis disease is much riskier than getting DTaP vaccine. However, like any medicine, this vaccine, can cause side effects. The risk of DTaP vaccine causing a serious side effect is extremely small.

Get emergency medical help if you have 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 the following serious side effects:

  • loss of consciousness;
  • seizure (black-out or convulsions);
  • high fever, over 105 degrees; or
  • non-stop crying for 3 hours or more.

Other less serious side effects may be more likely to occur. Talk to your doctor if your child has:

  • mild fever;
  • redness, pain, tenderness, or swelling where the shot was given;
  • fussiness for 1-3 days after the shot;
  • tiredness or poor appetite for 1-3 days after the shot; or
  • vomiting for 1-3 days after the shot.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.

To help reduce fever and pain, your doctor may recommend giving the child an aspirin-free pain reliever such as acetaminophen (Tylenol, Tempra, others) or ibuprofen (Motrin, Advil). This may be given at the time of the shot and over the next 24 hours. Your doctor will tell you the correct dose to use. Controlling fever is especially important if the child has a history of seizures.

What is the most important information I should know about diphtheria, tetanus, and pertussis vaccines (Certiva)?

Children should get 5 doses of DTaP vaccine, one dose at each of the following ages: 2 months, 4 months, 6 months, 15 to 18 months, and 4 to 6 years. The series should be completed before the child's seventh birthday.

Keep track of any and all side effects your child has after receiving this vaccine. When the child receives the next booster dose, you will need to tell the doctor if the first shot caused any side effects. Getting diphtheria, tetanus, or pertussis disease is much riskier than getting DTaP vaccine. However, like any medicine, this vaccine can cause side effects. The risk of DTaP vaccine causing a serious side effect is extremely small.

Any child who had a life-threatening allergic reaction after a dose of DTaP should not receive another dose.

Any child who has had encephalitis (brain swelling) or a brain or nervous system disease within 7 days after a dose of DTaP should not receive another dose.

Children with a cold or fever can still be vaccinated. Children who are moderately or severely ill should usually wait until they recover before getting DTaP vaccine.

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