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USP DI Vol. II - POLIOVIRUSVACCINE (Systemic)

POLIOVIRUSVACCINE (Systemic)


Some commonly used brand names are:

In the U.S.?

  • Ipol 2
  • Orimune 3

Other commonly used names are:

  • eIPV
  • IPV
  • N-IPV
  • OPV
  • Sabin vaccine
  • Salk vaccine
  • TOPV

Note:

For quick reference, the following poliovirus vaccines are numberedto match the corresponding brand names.

This information applies to the following medicines:
1.Poliovirus Vaccine Inactivated*?
2.Poliovirus Vaccine Inactivated Enhanced Potency??
3.Poliovirus Vaccine Live Oral?
* Not commercially available in the U.S.
? Not commercially available in Canada
? Generic name product may be available in the U.S.
? Generic name product may be available in Canada

Category

  • Immunizing agent, active?Poliovirus Vaccine Inactivated; Poliovirus Vaccine Inactivated Enhanced Potency; Poliovirus Vaccine Live Oral

Description

Poliovirus (poe-lee-oh VYE-russ) vaccine is an active immunizing agentused to prevent poliomyelitis (polio). It works by causing your body to produceits own protection (antibodies) against the virus that causes polio.

There are two types of polio vaccine that are given by injection, poliovirusvaccine inactivated (IPV) and poliovirus vaccine inactivated enhanced potency(eIPV). In the U.S. and Canada the type of vaccine that is given by injectionis eIPV. The type of vaccine that is given by mouth is called poliovirus vaccinelive oral (OPV).

Polio is a very serious infection that causes paralysis of the muscles,including the muscles that enable you to walk and breathe. A polio infectionmay leave a person unable to breathe without the help of an iron lung, unableto walk without leg braces, or confined to a wheelchair. There is no curefor polio.

Immunization against polio is recommended for all infants from 6 to 12weeks of age, all children, all adolescents up to 18 years of age, and certainadults who are at greater risk for exposure to polioviruses than the generalpopulation, including:

  • Persons traveling to areas or countries where polio is uncontrolled,whether or not they have been vaccinated against polio in the past.
  • Persons who live in areas where polio infection still occurs.
  • Adults who have not been vaccinated or who have not had the completeseries of vaccinations against polio and who live in households with childrenwho are to be given the oral polio vaccine (OPV).
  • Employees in day-care centers and group homes for children, suchas orphanages.
  • Employees in medical facilities, such as hospitals and doctors' offices.
  • Laboratory workers handling samples that may contain polioviruses.

Immunization against polio is not recommended for infants younger than6 weeks of age, because antibodies they received from their mothers beforebirth may interfere with the effectiveness of the vaccine. Infants who wereimmunized against polio before 6 weeks of age should receive the completepolio immunization series.

This vaccine is to be administered only by or under the supervision ofyour doctor or other health care professional. It is available in the followingdosage forms:

    Oral
  • Oral solution (U.S. and Canada)
    Parenteral
  • Injection (U.S. and Canada)


Before Receiving This Vaccine

For a while after you are immunized, there is a very small risk (1 in 2.2million) that any persons living in your household who have not yet been immunizedagainst polio or who have or had an immune deficiency condition may developpoliomyelitis (polio) from being around you. Talk to your doctor if you haveany questions about this.

In deciding to use a medicine, the risks of taking the medicine must beweighed against the good it will do. This is a decision you and your doctorwill make. For polio vaccine, the following should be considered:

Allergies?Tell your doctor if you have ever had any unusual orallergic reaction to polio vaccine or to neomycin, polymyxin B, or streptomycin.The polio vaccines available in the U.S. and Canada may contain neomycin,polymyxin B, and/or streptomycin. Also tell your health care professionalif you are allergic to any other substances, such as foods, preservatives,or dyes.

Pregnancy?Studies on effects in pregnancy havenot been done in either humans or animals. However, this vaccine has not beenshown to cause birth defects or other problems in humans. Although it is notrecommended for all pregnant women, polio vaccine is given to pregnant womenwho are at great risk of catching polio.

Breast-feeding?Polio vaccine has not been reported to cause problemsin nursing babies.

Children?Use is not recommended for infants up to 6 weeksof age. For infants and children 6 weeks of age and older, polio vaccine isnot expected to cause different side effects or problems than it does in adults.

Older adults?Many medicines have not been studied specificallyin older people. Therefore, it may not be known whether they work exactlythe same way they do in younger adults. Although there is no specific informationcomparing use of polio vaccine in the elderly with use in other age groups,this vaccine is not expected to cause different side effects or problems inolder persons than it does in younger adults.

Other medicines?Although certain medicines should not be usedtogether at all, in other cases two different medicines may be used togethereven if an interaction might occur. In these cases, your doctor may want tochange the dose, or other precautions may be necessary. Before you receivepolio vaccine, it is especially important that your health care professionalknow if you are receiving or have received any of the following:

  • Cancer medicines or
  • Corticosteroids (e.g., cortisone-like medicines) or
  • Radiation therapy?May reduce the useful effect of the vaccine

Other medical problems?The presence of other medicalproblems may affect the use of polio vaccine. Make sure you tell your doctorif you have any other medical problems, especially:

  • Diarrhea or
  • Virus infection or
  • Vomiting?The condition may reduce the useful effect of thevaccine
  • Fever or
  • Illness (moderate or severe) or
  • Weakness (severe)?The symptoms of the condition may be confusedwith possible side effects of the vaccine
  • Immune deficiency condition (or family history of)?The conditionmay increase the chance of side effects of the vaccine

Proper Use of This Vaccine

Make certain your health care professional knows if you are on any specialdiet, such as a low-sugar diet, because the oral solution form of polio vaccinemay be given to you on a sugar cube.

Dosing?The dose of polio vaccine will be differentfor different patients. The following information includes only the averagedoses of polio vaccine.

  • For prevention of polio:
    • For poliovirus vaccine live oral ( OPV) oral dosage form:
      • Adults and children 18 years of age and older?Use and dosemust be determined by your doctor.
      • Infants and children 6 weeks to 18 years of age?One dose isgiven at your first visit, then a second dose is given six to eight weekslater. A third dose is given eight to twelve months after the second dose.A booster dose is given at 4 to 6 years of age only if the third dose wasgiven before the child's fourth birthday. The doses are taken by mouth.
    • For poliovirus vaccine inactivated ( IPV) injection dosage form:
      • Adults and children 18 years of age and older?One dose is givenevery four to eight weeks for a total of three doses. A fourth dose is givensix to twelve months after the third dose. The doses are injected into a muscleor under the skin.
      • Children 6 weeks to 18 years of age?One dose is given everyfour to eight weeks for a total of three doses. A fourth dose is given sixto twelve months after the third dose. A booster dose is given at 4 to 6 yearsof age only if the fourth dose was given before the child's fourth birthday.The doses are injected into a muscle or under the skin.
    • For poliovirus vaccine inactivated enhanced potency ( eIPV) injection dosage form:
      • Adults and children 6 years of age and older?One dose is givenat your first visit, then a second dose is given four to eight weeks later.A third dose is given six to twelve months after the second dose. The dosesare injected into a muscle or under the skin.
      • Infants and children 6 weeks to 6 years of age?One dose isgiven at your first visit, then a second dose is given four to eight weekslater. A third dose is given six to twelve months after the second dose. Abooster dose is given at 4 to 6 years of age only if the third dose was givenbefore the child's fourth birthday. The doses are injected into a muscle underthe skin.

Precautions After Receiving This Vaccine

Tell your doctor that you have received this vaccine if you are to receiveany other live virus vaccines within 1 month after receiving this vaccine.


Side Effects of This Vaccine

In very rare instances (approximately 1 casein 760,000 doses), healthy persons who have taken the oral vaccine (OPV) andhealthy persons who are close contacts of adults or children who have takenOPV have been infected by the polio virus and have become paralyzed. No paralysiscaused by polio infection has occurred with the injected vaccine (IPV) since1955.

Along with its needed effects, a vaccine may cause some unwanted effects.Although not all of these side effects may occur, if they do occur they mayneed medical attention.

Get emergency help immediately if any of thefollowing side effects occur:

    Symptoms of allergic reaction

      Difficulty in breathing or swallowing; hives; itching, especially of feet or hands; reddening of skin, especially around ears; swelling of eyes, face, or inside of nose; unusualtiredness or weakness (sudden and severe)

More common

Fever over 102 ?F (39 ?C) (with injection)

Other side effects may occurthat usually do not need medical attention. However, check with your doctorif any of the following side effects continue or are bothersome:

    More common

      Irritability; loss of appetite; tiredness

    Less common?with injection

      Itching or skin rash; redness, soreness,hard lump, tenderness, or pain at the place of injection

Other side effects not listed above may also occur insome patients. If you notice any other effects, check with your doctor.


Revised: 10/19/1998