Adacel

DRUG DESCRIPTION

Adacel® , Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (Tdap), is a sterile liquid suspension of tetanus and diphtheria toxoids and acellular pertussis components adsorbed onto aluminum phosphate, for intramuscular administration. After shaking, the vaccine is a white, homogenous, cloudy suspension. Neither the vial nor the syringe for this product contain natural latex rubber.

Each dose of Adacel (tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed) vaccine (0.5 mL) contains the following active ingredients:

Acellular Pertussis
   Detoxified Pertussis Toxin (PT) 2.5 ?g
   Filamentous Hemagglutinin (FHA) 5 ?g
   Pertactin (PRN) 3 ?g
   Fimbriae Types 2 and 3 (FIM) 5 ?g
Tetanus Toxoid (T) 5 Lf
Diphtheria Toxoid (d) 2 Lf

Other ingredients per dose include 1.5 mg aluminum phosphate (0.33 mg aluminum) as the adjuvant, ? 5 ?g residual formaldehyde, < 50 ng residual glutaraldehyde and 3.3 mg (0.6% v/v) 2-phenoxyethanol (not as a preservative). The antigens are the same as those in DAPTACEL® , Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed (DTaP); however, Adacel (tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed) vaccine is formulated with reduced quantities of d and detoxified PT.

The acellular pertussis vaccine components are obtained from Bordetella pertussis cultures grown in Stainer-Scholte medium (1) modified by the addition of casamino acids and dimethyl-beta-cyclodextrin. PT, FHA and PRN are isolated separately from the supernatant culture medium. FIM are extracted and co-purified from the bacterial cells. The pertussis antigens are purified by sequential filtration, salt-precipitation, ultrafiltration and chromatography. PT is detoxified with glutaraldehyde, FHA is treated with formaldehyde, and the residual aldehydes are removed by ultrafiltration. The individual antigens are adsorbed onto aluminum phosphate.

Corynebacterium diphtheriae is grown in modified Mueller's growth medium. (2) After purification by ammonium sulfate fractionation, diphtheria toxin is detoxified with formaldehyde and diafiltered. Clostridium tetani is grown in modified Mueller-Miller casamino acid medium without beef heart infusion. (3) Tetanus toxin is detoxified with formaldehyde and purified by ammonium sulfate fractionation and diafiltration. Diphtheria and tetanus toxoids are individually adsorbed onto aluminum phosphate.

The adsorbed diphtheria, tetanus and acellular pertussis components are combined with aluminum phosphate (as adjuvant), 2-phenoxyethanol (not as a preservative) and water for injection.

Tetanus and diphtheria toxoid potency is determined by measuring the amount of neutralizing antitoxin in previously immunized guinea pigs. The tetanus component induces at least 2 neutralizing units/mL of serum and the diphtheria component induces at least 0.5 neutralizing units/mL of serum. The potency of the acellular pertussis vaccine components is evaluated by the antibody response of immunized mice to detoxified PT, FHA, PRN and FIM as measured by enzyme-linked immunosorbent assay (ELISA).

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

You should not receive this vaccine a second time if you had a life-threatening allergic reaction after the first shot.

Keep track of any and all side effects you have after receiving this vaccine. If you ever have to receive another vaccine in the future, you will need to tell the doctor if the first shot caused any side effects.

Becoming infected with diphtheria, pertussis, or tetanus is much more dangerous to your health than receiving the vaccine to protect against these...

Read All Potential Side Effects and See Pictures of Adacel »

What are the precautions when taking tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed (Adacel)?

Before receiving this vaccination, tell your doctor or pharmacist if you are allergic to it; or to any other vaccines; or if you have any other allergies. This product may contain inactive ingredients (such as latex), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: uncontrolled seizures or other nervous system disorder (e.g., encephalopathy), history of severe reaction to vaccine (e.g., paralysis, encephalopathy).

Before using this medication, tell your doctor or pharmacist your medical history, especially of: bleeding disorders (e.g., hemophilia, low platelets), history of...

Read All Potential Precautions of Adacel »

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

You should not receive this vaccine a second time if you had a life-threatening allergic reaction after the first shot.

Keep track of any and all side effects you have after receiving this vaccine. If you ever have to receive another vaccine in the future, you will need to tell the doctor if the first shot caused any side effects.

Becoming infected with diphtheria, pertussis, or tetanus is much more dangerous to your health than receiving the vaccine to protect against these...

Read All Potential Side Effects and See Pictures of Adacel »

What are the precautions when taking tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed (Adacel)?

Before receiving this vaccination, tell your doctor or pharmacist if you are allergic to it; or to any other vaccines; or if you have any other allergies. This product may contain inactive ingredients (such as latex), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: uncontrolled seizures or other nervous system disorder (e.g., encephalopathy), history of severe reaction to vaccine (e.g., paralysis, encephalopathy).

Before using this medication, tell your doctor or pharmacist your medical history, especially of: bleeding disorders (e.g., hemophilia, low platelets), history of...

Read All Potential Precautions of Adacel »

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

You should not receive this vaccine a second time if you had a life-threatening allergic reaction after the first shot.

Keep track of any and all side effects you have after receiving this vaccine. If you ever have to receive another vaccine in the future, you will need to tell the doctor if the first shot caused any side effects.

Becoming infected with diphtheria, pertussis, or tetanus is much more dangerous to your health than receiving the vaccine to protect against these...

Read All Potential Side Effects and See Pictures of Adacel »

What are the precautions when taking tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed (Adacel)?

Before receiving this vaccination, tell your doctor or pharmacist if you are allergic to it; or to any other vaccines; or if you have any other allergies. This product may contain inactive ingredients (such as latex), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: uncontrolled seizures or other nervous system disorder (e.g., encephalopathy), history of severe reaction to vaccine (e.g., paralysis, encephalopathy).

Before using this medication, tell your doctor or pharmacist your medical history, especially of: bleeding disorders (e.g., hemophilia, low platelets), history of...

Read All Potential Precautions of Adacel »

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

You should not receive this vaccine a second time if you had a life-threatening allergic reaction after the first shot.

Keep track of any and all side effects you have after receiving this vaccine. If you ever have to receive another vaccine in the future, you will need to tell the doctor if the first shot caused any side effects.

Becoming infected with diphtheria, pertussis, or tetanus is much more dangerous to your health than receiving the vaccine to protect against these...

Read All Potential Side Effects and See Pictures of Adacel »

What are the precautions when taking tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed (Adacel)?

Before receiving this vaccination, tell your doctor or pharmacist if you are allergic to it; or to any other vaccines; or if you have any other allergies. This product may contain inactive ingredients (such as latex), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: uncontrolled seizures or other nervous system disorder (e.g., encephalopathy), history of severe reaction to vaccine (e.g., paralysis, encephalopathy).

Before using this medication, tell your doctor or pharmacist your medical history, especially of: bleeding disorders (e.g., hemophilia, low platelets), history of...

Read All Potential Precautions of Adacel »

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

You should not receive this vaccine a second time if you had a life-threatening allergic reaction after the first shot.

Keep track of any and all side effects you have after receiving this vaccine. If you ever have to receive another vaccine in the future, you will need to tell the doctor if the first shot caused any side effects.

Becoming infected with diphtheria, pertussis, or tetanus is much more dangerous to your health than receiving the vaccine to protect against these...

Read All Potential Side Effects and See Pictures of Adacel »

What are the precautions when taking tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed (Adacel)?

Before receiving this vaccination, tell your doctor or pharmacist if you are allergic to it; or to any other vaccines; or if you have any other allergies. This product may contain inactive ingredients (such as latex), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: uncontrolled seizures or other nervous system disorder (e.g., encephalopathy), history of severe reaction to vaccine (e.g., paralysis, encephalopathy).

Before using this medication, tell your doctor or pharmacist your medical history, especially of: bleeding disorders (e.g., hemophilia, low platelets), history of...

Read All Potential Precautions of Adacel »


Adacel Consumer (continued)

SIDE EFFECTS: Headache, tiredness, body aches, nausea, diarrhea, fever, chills, vomiting, pain/swelling/redness at the injection site, or sore/swollen joints may occur. Acetaminophen or ibuprofen may be used to reduce soreness. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these rare but very serious side effects occur: difficulty breathing, high fever (higher than 104 degrees F/40 degrees C), numbness/tingling, muscle weakness, inability to move (paralysis).

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

Contact your doctor for medical advice about side effects. The following numbers do not provide medical advice, but in the US, you may report side effects to the Vaccine Adverse Event Reporting System (VAERS) at 1-800-822-7967. In Canada, you may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before receiving this vaccination, tell your doctor or pharmacist if you are allergic to it; or to any other vaccines; or if you have any other allergies. This product may contain inactive ingredients (such as latex), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: uncontrolled seizures or other nervous system disorder (e.g., encephalopathy), history of severe reaction to vaccine (e.g., paralysis, encephalopathy).

Before using this medication, tell your doctor or pharmacist your medical history, especially of: bleeding disorders (e.g., hemophilia, low platelets), history of Guillain-Barre syndrome, immune system disorders (e.g., autoimmune disorders, radiation treatment), current illness/infection, seizures (e.g., epilepsy controlled by medication, febrile seizures), other nervous system disorders (e.g., paralysis, numbness/tingling, severe drowsiness, confusion), previous reactions to any vaccine (e.g., high fever, seizures).

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is not known whether this drug passes into breast milk. Consult your doctor before breast-feeding.


Adacel Patient Information Including Side Effects

Brand Names: Adacel (Tdap), Boostrix (Tdap)

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

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

What is tetanus, diphtheria, acellular pertussis vaccine (Tdap) (Adacel)?

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, 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 adult vaccine (also called Tdap) is used to help prevent these diseases in people who are ages 10 to 64 years old. Most people in this age group require only one Tdap shot for protection against these diseases.

This vaccine works by exposing you 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 Tdap vaccine may not provide protection from disease in every person.

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

You should not receive this vaccine a second time if you had a life-threatening allergic reaction after the first shot.

Keep track of any and all side effects you have after receiving this vaccine. If you ever have to receive another vaccine in the future, you will need to tell the doctor if the first shot caused any side effects.

Becoming infected with diphtheria, pertussis, or tetanus is much more dangerous to your 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 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 you have any of these serious side effects within 7 days after receiving this vaccine:

  • extreme drowsiness, fainting;
  • 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;
  • headache or tiredness;
  • joint pain, body aches; 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 this vaccine (Adacel)?

In most cases, tetanus, diphtheria, acellular pertussis vaccine is given in only one dose. Follow your doctor's instructions about receiving a booster dose if needed.

You can still receive a vaccine if you have a cold or fever. In the case of a more severe illness with a fever or any type of infection, wait until you get better before receiving this vaccine.

You should not receive this vaccine a second time if you had a life-threatening allergic reaction after the first shot.

Keep track of any and all side effects you have after receiving this vaccine. If you ever need to receive the vaccine again, you will need to tell your doctor if the first shot caused any side effects.

Becoming infected with diphtheria, pertussis, or tetanus is much more dangerous to your 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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