Pentacel

DRUG DESCRIPTION

Pentacel (tetanus toxoid conjugate) , [Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus b Conjugate (Tetanus Toxoid Conjugate) Vaccine] (DTaP-IPV/Hib) is a vaccine for intramuscular injection. It consists of a Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed and Inactivated Poliovirus (DTaP-IPV) component and an ActHIB® vaccine component. ActHIB vaccine (Haemophilus b Conjugate Vaccine [Tetanus Toxoid Conjugate]), consists of Haemophilus influenzae type b capsular polysaccharide (polyribosyl-ribitol-phosphate [PRP]) covalently bound to tetanus toxoid (PRP-T). The DTaP-IPV component is supplied as a sterile liquid used to reconstitute the lyophilized ActHIB vaccine component to form Pentacel (tetanus toxoid conjugate) vaccine. Pentacel (tetanus toxoid conjugate) vaccine is a uniform, cloudy, white to off-white (yellow tinge) suspension.

Each 0.5 mL dose of Pentacel vaccine contains the following active ingredients:
diphtheria toxoid 15 Lf
tetanus toxoid 5 Lf
acellular pertussis antigens:  
  pertussis toxin (PT) detoxified 20 ?µg
  filamentous hemagglutinin (FHA) 20 ?µg
  pertactin (PRN) 3 ?µg
  fimbriae types 2 and 3 (FIM) 5 ?µg
inactivated polioviruses:  
  Type 1 (Mahoney) 40 D-antigen units
  Type 2 (MEF-1) 8 D-antigen units
  Type 3 (Saukett) 32 D-antigen units
PRP of Haemophilus influenzae type b covalently bound to 24 ?µg of tetanus toxoid (PRP-T) 10 ?µg

Other ingredients per 0.5 mL dose include 1.5 mg aluminum phosphate (0.33 mg aluminum) as the adjuvant, polysorbate 80 (approximately 10 ppm by calculation), ? 5 ?µg residual formaldehyde, < 50 ng residual glutaraldehyde, ? 50 ng residual bovine serum albumin, 3.3 mg (0.6% v/v) 2-phenoxyethanol (not as a preservative) and < 4 pg of neomycin and < 4 pg polymyxin B sulfate.

Corynebacterium diphtheriae is grown in modified Mueller's growth medium. (1) After purification by ammonium sulfate fractionation, the diphtheria toxin is detoxified with formaldehyde and diafiltered.

Clostridium tetani is grown in modified Mueller-Miller casamino acid medium. (2) Tetanus toxin is detoxified with formaldehyde and purified by ammonium sulfate fractionation and diafiltration. Diphtheria and tetanus toxoidsare individually adsorbed onto aluminum phosphate.

The acellular pertussis vaccine antigens are produced from Bordetella pertussis cultures grown in Stainer-Scholte medium (3) 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 copurified 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 separately onto aluminum phosphate.

Poliovirus Type 1, Type 2 and Type 3 are eachgrown in separate culture s of MRC-5 cells, a line of normal human diploid cells, by the microcarrier method. (4) (5) The cells are grown in CMRL (Connaught Medical Research Laboratories) 1969 medium, supplemented with calf serum. For viral growth, the culture medium is replaced by Medium 199, without calf serum. After clarification and filtration, the viral suspensions are concentrated by ultrafiltration, and purified by liquid chromatography steps. The monovalent viral suspensions are inactivated with formaldehyde. Monovalent concentrates of each inactivated poliovirus are combined to produce a trivalent poliovirus concentrate.

The adsorbed diphtheria, tetanus and acellular pertussis antigens are combined into an intermediate concentrate. The trivalent poliovirus concentrate is added and the DTaP-IPV component is diluted to its final concentration. The DTaP-IPV component does not contain a preservative.

Both diphtheria and tetanus toxoids induce at least 2 neutralizing units per mL in the guinea pig potency test. The potency of the acellular pertussis antigens is evaluated by the antibody response of immunized mice to PT, FHA, PRN and FIM as measured by enzyme-linked immunosorbent assay (ELISA). The immunogenicity of the inactivated polioviruses is evaluated by the antibody response in monkeys measured by virus neutralization.

PRP, a high molecular weight polymer, is prepared from the Haemophilus influenzae type b strain 1482 grown in a semi-synthetic medium. (6) The tetanus toxoid for conjugation to PRP is prepared by ammonium sulfate purification, and formalin inactivation of the toxin from cultures of Clostridium tetani (Harvard strain) grown in a modified Mueller and Miller medium. (7) The toxoid is filter sterilized prior to the conjugation process. The ActHIB vaccine component does not contain a preservative. Potency of the ActHIB vaccine componentis specified on each lot by limits on the content of PRP polysaccharide and protein per dose and the proportion of polysaccharide and protein that is characterized as high molecular weight conjugate.

What are the possible side effects of this vaccine (Pentacel)?

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, haemophilus influenzae, pertussis, tetanus, or polio is much more dangerous to your child's health than receiving the vaccine to protect against these diseases. Like any...

Read All Potential Side Effects and See Pictures of Pentacel »

What are the precautions when taking tetanus toxoid conjugate (Pentacel)?

Before your child receives this vaccination, tell the doctor or pharmacist if your child is allergic to it; or to any other vaccine; or if your child has 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.

Before receiving this vaccination, tell the doctor or pharmacist your child's medical history, especially of: current fever/illness, bleeding/blood clotting problems (such as hemophilia, low platelets), immune system problems (such as HIV infection), cancer, brain/nervous system disorders (such as seizures), history of Guillain-Barre syndrome.

This vaccine is not usually used in adults. Therefore, it is unlikely to be used during pregnancy or by...

Read All Potential Precautions of Pentacel »

What are the possible side effects of this vaccine (Pentacel)?

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, haemophilus influenzae, pertussis, tetanus, or polio is much more dangerous to your child's health than receiving the vaccine to protect against these diseases. Like any...

Read All Potential Side Effects and See Pictures of Pentacel »

What are the precautions when taking tetanus toxoid conjugate (Pentacel)?

Before your child receives this vaccination, tell the doctor or pharmacist if your child is allergic to it; or to any other vaccine; or if your child has 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.

Before receiving this vaccination, tell the doctor or pharmacist your child's medical history, especially of: current fever/illness, bleeding/blood clotting problems (such as hemophilia, low platelets), immune system problems (such as HIV infection), cancer, brain/nervous system disorders (such as seizures), history of Guillain-Barre syndrome.

This vaccine is not usually used in adults. Therefore, it is unlikely to be used during pregnancy or by...

Read All Potential Precautions of Pentacel »

What are the possible side effects of this vaccine (Pentacel)?

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, haemophilus influenzae, pertussis, tetanus, or polio is much more dangerous to your child's health than receiving the vaccine to protect against these diseases. Like any...

Read All Potential Side Effects and See Pictures of Pentacel »

What are the precautions when taking tetanus toxoid conjugate (Pentacel)?

Before your child receives this vaccination, tell the doctor or pharmacist if your child is allergic to it; or to any other vaccine; or if your child has 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.

Before receiving this vaccination, tell the doctor or pharmacist your child's medical history, especially of: current fever/illness, bleeding/blood clotting problems (such as hemophilia, low platelets), immune system problems (such as HIV infection), cancer, brain/nervous system disorders (such as seizures), history of Guillain-Barre syndrome.

This vaccine is not usually used in adults. Therefore, it is unlikely to be used during pregnancy or by...

Read All Potential Precautions of Pentacel »

What are the possible side effects of this vaccine (Pentacel)?

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, haemophilus influenzae, pertussis, tetanus, or polio is much more dangerous to your child's health than receiving the vaccine to protect against these diseases. Like any...

Read All Potential Side Effects and See Pictures of Pentacel »

What are the precautions when taking tetanus toxoid conjugate (Pentacel)?

Before your child receives this vaccination, tell the doctor or pharmacist if your child is allergic to it; or to any other vaccine; or if your child has 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.

Before receiving this vaccination, tell the doctor or pharmacist your child's medical history, especially of: current fever/illness, bleeding/blood clotting problems (such as hemophilia, low platelets), immune system problems (such as HIV infection), cancer, brain/nervous system disorders (such as seizures), history of Guillain-Barre syndrome.

This vaccine is not usually used in adults. Therefore, it is unlikely to be used during pregnancy or by...

Read All Potential Precautions of Pentacel »

What are the possible side effects of this vaccine (Pentacel)?

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, haemophilus influenzae, pertussis, tetanus, or polio is much more dangerous to your child's health than receiving the vaccine to protect against these diseases. Like any...

Read All Potential Side Effects and See Pictures of Pentacel »

What are the precautions when taking tetanus toxoid conjugate (Pentacel)?

Before your child receives this vaccination, tell the doctor or pharmacist if your child is allergic to it; or to any other vaccine; or if your child has 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.

Before receiving this vaccination, tell the doctor or pharmacist your child's medical history, especially of: current fever/illness, bleeding/blood clotting problems (such as hemophilia, low platelets), immune system problems (such as HIV infection), cancer, brain/nervous system disorders (such as seizures), history of Guillain-Barre syndrome.

This vaccine is not usually used in adults. Therefore, it is unlikely to be used during pregnancy or by...

Read All Potential Precautions of Pentacel »

What are the possible side effects of this vaccine (Pentacel)?

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, haemophilus influenzae, pertussis, tetanus, or polio is much more dangerous to your child's health than receiving the vaccine to protect against these diseases. Like any...

Read All Potential Side Effects and See Pictures of Pentacel »

What are the precautions when taking tetanus toxoid conjugate (Pentacel)?

Before your child receives this vaccination, tell the doctor or pharmacist if your child is allergic to it; or to any other vaccine; or if your child has 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.

Before receiving this vaccination, tell the doctor or pharmacist your child's medical history, especially of: current fever/illness, bleeding/blood clotting problems (such as hemophilia, low platelets), immune system problems (such as HIV infection), cancer, brain/nervous system disorders (such as seizures), history of Guillain-Barre syndrome.

This vaccine is not usually used in adults. Therefore, it is unlikely to be used during pregnancy or by...

Read All Potential Precautions of Pentacel »

What are the possible side effects of this vaccine (Pentacel)?

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, haemophilus influenzae, pertussis, tetanus, or polio is much more dangerous to your child's health than receiving the vaccine to protect against these diseases. Like any...

Read All Potential Side Effects and See Pictures of Pentacel »

What are the precautions when taking tetanus toxoid conjugate (Pentacel)?

Before your child receives this vaccination, tell the doctor or pharmacist if your child is allergic to it; or to any other vaccine; or if your child has 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.

Before receiving this vaccination, tell the doctor or pharmacist your child's medical history, especially of: current fever/illness, bleeding/blood clotting problems (such as hemophilia, low platelets), immune system problems (such as HIV infection), cancer, brain/nervous system disorders (such as seizures), history of Guillain-Barre syndrome.

This vaccine is not usually used in adults. Therefore, it is unlikely to be used during pregnancy or by...

Read All Potential Precautions of Pentacel »

What are the possible side effects of this vaccine (Pentacel)?

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, haemophilus influenzae, pertussis, tetanus, or polio is much more dangerous to your child's health than receiving the vaccine to protect against these diseases. Like any...

Read All Potential Side Effects and See Pictures of Pentacel »

What are the precautions when taking tetanus toxoid conjugate (Pentacel)?

Before your child receives this vaccination, tell the doctor or pharmacist if your child is allergic to it; or to any other vaccine; or if your child has 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.

Before receiving this vaccination, tell the doctor or pharmacist your child's medical history, especially of: current fever/illness, bleeding/blood clotting problems (such as hemophilia, low platelets), immune system problems (such as HIV infection), cancer, brain/nervous system disorders (such as seizures), history of Guillain-Barre syndrome.

This vaccine is not usually used in adults. Therefore, it is unlikely to be used during pregnancy or by...

Read All Potential Precautions of Pentacel »

What are the possible side effects of this vaccine (Pentacel)?

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, haemophilus influenzae, pertussis, tetanus, or polio is much more dangerous to your child's health than receiving the vaccine to protect against these diseases. Like any...

Read All Potential Side Effects and See Pictures of Pentacel »

What are the precautions when taking tetanus toxoid conjugate (Pentacel)?

Before your child receives this vaccination, tell the doctor or pharmacist if your child is allergic to it; or to any other vaccine; or if your child has 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.

Before receiving this vaccination, tell the doctor or pharmacist your child's medical history, especially of: current fever/illness, bleeding/blood clotting problems (such as hemophilia, low platelets), immune system problems (such as HIV infection), cancer, brain/nervous system disorders (such as seizures), history of Guillain-Barre syndrome.

This vaccine is not usually used in adults. Therefore, it is unlikely to be used during pregnancy or by...

Read All Potential Precautions of Pentacel »


Pentacel Consumer (continued)

SIDE EFFECTS: Pain/swelling/redness at the injection site may occur. Mild fever, irritability/crying, sleepiness, vomiting, loss of appetite, and diarrhea may also occur. If any of these effects persist or worsen, tell the doctor or pharmacist promptly. Consult the doctor or pharmacist about the temporary use of acetaminophen to treat pain and fever due to this vaccine.

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

Seek immediate medical attention if any of these rare but serious side effects occur: persistent crying (beginning within 48 hours of the injection and lasting longer than 3 hours), high fever (105 degrees F/40 degrees C or higher), little or no response to sound/touch, weak/floppy muscles, seizures.

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 the 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 your child receives this vaccination, tell the doctor or pharmacist if your child is allergic to it; or to any other vaccine; or if your child has 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.

Before receiving this vaccination, tell the doctor or pharmacist your child's medical history, especially of: current fever/illness, bleeding/blood clotting problems (such as hemophilia, low platelets), immune system problems (such as HIV infection), cancer, brain/nervous system disorders (such as seizures), history of Guillain-Barre syndrome.

This vaccine is not usually used in adults. Therefore, it is unlikely to be used during pregnancy or by a mother while breast-feeding. Consult the doctor if you have any questions about using this vaccine.


Pentacel Patient Information Including Side Effects

Brand Names: Pentacel

Generic Name: diphtheria, haemophilus, pertussis, tetanus, and polio (Pronunciation: dif THEER ee a, hem OFF il us, per TUS is, TET a nus, POE lee oh)

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

What is diphtheria, haemophilus influenzae, pertussis, tetanus, and polio vaccine (Pentacel)?

Diphtheria, haemophilus influenzae, pertussis, tetanus, and polio 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.

Haemophilus influenzae can cause minor flu symptoms or it can cause more serious symptoms such as swelling around the throat, making it hard to swallow or breathe. Haemophilus influenzae can also cause swelling of the membranes around the brain and spinal cord (meningitis).

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.

Polio affects the central nervous system and spinal cord. It can cause muscle weakness and paralysis. Polio is a life-threatening condition because it can paralyze the muscles that help you breathe.

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

The diphtheria, haemophilus influenzae, pertussis, tetanus, and polio vaccine is used to help prevent these diseases in children who are ages 6 weeks through 4 years (before the 5th 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 diphtheria, haemophilus influenzae, pertussis, tetanus, and polio vaccine may not provide protection from disease in every person.

What are the possible side effects of this vaccine (Pentacel)?

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, haemophilus influenzae, pertussis, tetanus, or polio 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 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 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 may include:

  • redness, pain, tenderness, or swelling where the shot was given;
  • low fever;
  • mild fussiness or crying;
  • headache or tiredness;
  • 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. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about this vaccine (Pentacel)?

The diphtheria, haemophilus influenzae, pertussis, tetanus, and polio 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, and 15 to 18 months of age. Your child's individual booster schedule may be different from these guidelines. Follow your doctor's instructions or the schedule recommended by the health department of the state you live in.

Be sure your child receives all recommended doses of this vaccine. If your 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, haemophilus influenzae, pertussis, tetanus, or polio 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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