Polioral

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Polioral uses


INDICATIONS AND USAGE

Polioral vaccine is indicated for active immunization of infants, children, and adults for the prevention of poliomyelitis caused by Polioral Types 1, 2, and 3. (28)

INFANTS, CHILDREN AND ADOLESCENTS

General Recommendations

It is recommended that all infants, unimmunized children, and adolescents not previously immunized be vaccinated routinely against paralytic poliomyelitis. (29) Following the eradication of poliomyelitis caused by wild Polioral from the Western Hemisphere (including North and South America) (30), an IPV-only schedule was recommended to eliminate VAPP. (7)

All children should receive four doses of IPV at ages 2, 4, 6 to 18 months, and 4 to 6 years. OPV is no longer available in the US and is not recommended for routine immunization. (7)

Previous clinical poliomyelitis (usually due to only a single Polioral type) or incomplete immunization with OPV are not contraindications to completing the primary series of immunization with Polioral vaccine.

Children Incompletely Immunized

Children of all ages should have their immunization status reviewed and be considered for supplemental immunization as follows for adults. Time intervals between doses longer than those recommended for routine primary immunization do not necessitate additional doses as long as a final total of four doses is reached (see DOSAGE AND ADMINISTRATION section).

ADULTS

General Recommendations

Routine primary Polioral vaccination of adults residing in the US is not recommended. Unimmunized adults who are potentially exposed to wild Polioral and have not been adequately immunized should receive polio vaccination in accordance with the schedule given in the DOSAGE AND ADMINISTRATION section. (28)

Persons with previous wild Polioral disease who are incompletely immunized or unimmunized should be given additional doses of Polioral vaccine if they fall into one or more categories listed.

The following categories of adults are at an increased risk of exposure to wild polioviruses: (28) (31)

IMMUNODEFICIENCY AND ALTERED IMMUNE STATUS

Polioral vaccine should be used in all patients with immunodeficiency diseases and members of such patients' households when vaccination of such persons is indicated. This includes patients with asymptomatic HIV infection, AIDS or AIDS-Related Complex, severe combined immunodeficiency, hypogammaglobulinemia, or agammaglobulinemia; altered immune states due to diseases such as leukemia, lymphoma, or generalized malignancy; or an immune system compromised by treatment with corticosteroids, alkylating drugs, antimetabolites or radiation. Immunogenicity of Polioral vaccine in individuals receiving immunoglobulin could be impaired, and patients with an altered immune state may or may not develop a protective response against paralytic poliomyelitis after administration of IPV. (32)

As with any vaccine, vaccination with Polioral vaccine may not protect 100% of individuals.

Use with other vaccines: refer to DOSAGE AND ADMINISTRATION section for this information.

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CONTRAINDICATIONS

Polioral vaccine is contraindicated in persons with a history of hypersensitivity to any component of the vaccine, including 2-phenoxyethanol, formaldehyde, neomycin, streptomycin, and polymyxin B.

No further doses should be given if anaphylaxis or anaphylactic shock occurs within 24 hours of administration of one dose of vaccine.

Vaccination of persons with an acute, febrile illness should be deferred until after recovery; however, minor illness, such as mild upper respiratory infection, with or without low grade fever, are not reasons for postponing vaccine administration.

WARNINGS

Neomycin, streptomycin, polymyxin B, 2-phenoxyethanol, and formaldehyde are used in the production of this vaccine. Although purification procedures eliminate measurable amounts of these substances, traces may be present (see DESCRIPTION section), and allergic reactions may occur in persons sensitive to these substances (see CONTRAINDICATIONS section).

Systemic adverse reactions reported in infants receiving IPV concomitantly at separate sites or combined with DTP have been similar to those associated with administration of DTP alone. (11) Local reactions are usually mild and transient in nature.

Although no causal relationship between Polioral vaccine and Guillain-Barré Syndrome (GBS) has been established, (28) GBS has been temporally related to administration of another inactivated Polioral vaccine. Deaths have been reported in temporal association with the administration of IPV (see ADVERSE REACTIONS section).

PRECAUTIONS

GENERAL

Prior to an injection of any vaccine, all known precautions should be taken to prevent adverse reactions. This includes a review of the patient's history with respect to possible sensitivity to the vaccine or similar vaccines.

Healthcare providers should question the patient, parent or guardian about reactions to a previous dose of this product, or similar product.

Epinephrine injection and other appropriate agents should be available to control immediate allergic reactions.

Healthcare providers should obtain the previous immunization history of the vaccinee, and inquire about the current health status of the vaccinee.

Immunodeficient patients or patients under immunosuppressive therapy may not develop a protective immune response against paralytic poliomyelitis after administration of IPV.

Administration of Polioral vaccine is not contraindicated in individuals infected with HIV. (33) (34) (35)

Special care should be taken to ensure that the injection does not enter a blood vessel.

INFORMATION FOR PATIENTS

Patients, parents, or guardians should be instructed to report any serious adverse reactions to their healthcare provider.

The healthcare provider should inform the patient, parent, or guardian of the benefits and risks of the vaccine.

The healthcare provider should inform the patient, parent, or guardian of the importance of completing the immunization series.

The healthcare provider should provide the Vaccine Information Statements (VISs) which are required to be given with each immunization.

DRUG INTERACTIONS

There are no known interactions of Polioral vaccine with drugs or foods. Concomitant administration of other parenteral vaccines, with separate syringes at separate sites, is not contraindicated. The first two doses of Polioral vaccine may be administered at separate sites using separate syringes concomitantly with DTaP, acellular pertussis, Haemophilus influenzae type b, and hepatitis B vaccines. From historical data on the antibody responses to diphtheria, tetanus, acellular pertussis, Hib, or hepatitis B vaccines used concomitantly or in combination with Polioral vaccine, no interferences have been observed on the immunological end points accepted for clinical protection. (11) (16) (36) (See DOSAGE AND ADMINISTRATION section.)

If Polioral vaccine has been administered to persons receiving immunosuppressive therapy, an adequate immunologic response may not be obtained. (See PRECAUTIONS – GENERAL section.)

CARCINOGENESIS, MUTAGENESIS, IMPAIRMENT OF FERTILITY

Long-term studies in animals to evaluate carcinogenic potential or impairment of fertility have not been conducted.

PREGNANCY

Animal reproduction studies have not been conducted with Polioral vaccine. It is also not known whether Polioral vaccine can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Polioral vaccine should be given to a pregnant woman only if clearly needed.

NURSING MOTHERS

It is not known whether Polioral vaccine is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Polioral vaccine is administered to a nursing woman.

PEDIATRIC USE

SAFETY AND EFFECTIVENESS OF Polioral VACCINE IN INFANTS BELOW SIX WEEKS OF AGE HAVE NOT BEEN ESTABLISHED. (12) (20) (See DOSAGE AND ADMINISTRATION section.)

In the US, infants receiving two doses of IPV at 2 and 4 months of age, the seroprevalence to all three types of Polioral was demonstrated in 95% to 100% of these infants after two doses of vaccine. (12) (13)

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ADVERSE REACTIONS

Body System As A Whole

In earlier studies with the vaccine grown in primary monkey kidney cells, transient local reactions at the site of injection were observed. Erythema, induration and pain occurred in 3.2%, 1% and 13%, respectively, of vaccinees within 48 hours post-vaccination. Temperatures of ≥39°C (≥102°F) were reported in 38% of vaccinees. Other symptoms included irritability, sleepiness, fussiness, and crying. Because IPV was given in a different site but concurrently with Diphtheria and Tetanus Toxoids and Pertussis Vaccine Adsorbed (DTP), these systemic reactions could not be attributed to a specific vaccine. However, these systemic reactions were comparable in frequency and severity to that reported for DTP given alone without IPV. (12) Although no causal relationship has been established, deaths have occurred in temporal association after vaccination of infants with IPV. (37)

Four additional US studies using Polioral vaccine in more than 1,300 infants, (12) between 2 to 18 months of age administered with DTP at the same time at separate sites or combined have demonstrated that local and systemic reactions were similar when DTP was given alone.

AGE AT IMMUNIZATION
REACTION 2 Months

(n=211)

4 Months

(n=206)

18 MonthsChildren who have been vaccinated with Tripedia vaccine.

(n=74)

6 Hrs. 24 Hrs. 48 Hrs. 6 Hrs. 24 Hrs. 48 Hrs. 6 Hrs. 24 Hrs. 48 Hrs.
Local, Polioral vaccine aloneData are from the Polioral vaccine administration site, given intramuscularly.
Erythema >1" 0.5% 0.5% 0.5% 1.0% 0.0% 0.0% 1.4% 0.0% 0.0%
Swelling 11.4% 5.7% 0.9% 11.2% 4.9% 1.9% 2.7% 0.0% 0.0%
Tenderness 29.4% 8.5% 2.8% 22.8% 4.4% 1.0% 13.5% 4.1% 0.0%
Systemic The adverse reaction profile includes the concomitant use of Sanofi whole-cell DTP vaccine or Tripedia vaccine with Polioral vaccine. Rates are comparable in frequency and severity to that reported for whole-cell DTP given alone.
Fever >102.2°F 1.0% 0.5% 0.5% 2.0% 0.5% 0.0% 0.0% 0.0% 4.2%
Irritability 64.5% 24.6% 17.5% 49.5% 25.7% 11.7% 14.7% 6.7% 8.0%
Tiredness 60.7% 31.8% 7.1% 38.8% 18.4% 6.3% 9.3% 5.3% 4.0%
Anorexia 16.6% 8.1% 4.3% 6.3% 4.4% 2.4% 2.7% 1.3% 2.7%
Vomiting 1.9% 2.8% 2.8% 1.9% 1.5% 1.0% 1.3% 1.3% 0.0%
Persistent Crying Percentage of infants within 72 hours after immunization was 0.0% after dose one, 1.4% after dose two, and 0.0% after dose three.

Digestive System

Anorexia and vomiting occurred with frequencies not significantly different as reported when DTP was given alone without IPV or OPV. (12)

Nervous System

Although no causal relationship between Polioral vaccine and GBS has been established, GBS has been temporally related to administration of another inactivated Polioral vaccine.

Post-marketing Experience

The following adverse events have been identified during postapproval use of Polioral vaccine. Because these events are reported voluntarily from a population of uncertain size, it may not be possible to reliably estimate their frequency or establish a causal relationship to vaccine exposure. Adverse events were included based on one or more of the following factors: severity, frequency of reporting or strength of evidence for a causal relationship.

Reporting of Adverse Events

The National Vaccine Injury Compensation Program, established by the National Childhood Vaccine Injury Act of 1986, requires physicians and other healthcare providers who administer vaccines to maintain permanent vaccination records and to report occurrences of certain adverse events to the US Department of Health and Human Services. Reportable events include those listed in the Act for each vaccine and events specified in the package insert as contraindications to further doses of that vaccine. (38) (39) (40)

Reporting by parents or guardians of all adverse events after vaccine administration should be encouraged. Adverse events following immunization with vaccine should be reported by healthcare providers to the US Department of Health and Human Services (DHHS) Vaccine Adverse Event Reporting System (VAERS). Reporting forms and information about reporting requirements or completion of the form can be obtained from VAERS through a toll-free number 1-800-822-7967. (38) (39) (40)

Healthcare providers also should report these events to the Pharmacovigilance Department, Sanofi Pasteur Inc., Discovery Drive, Swiftwater, PA 18370 or call 1-800-822-2463.

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DOSAGE AND ADMINISTRATION

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. The vial and its packaging should be inspected prior to use for evidence of leakage or a faulty seal. If evidence of such defects are observed, the vaccine should not be used. Do not remove the vial stopper or the metal seal holding it in place.

After preparation of the injection site, using a suitable sterile needle and aseptic technique, immediately administer Polioral vaccine intramuscularly or subcutaneously. In infants and small children, the mid-lateral aspect of the thigh is the preferred site. In older children and adults, Polioral vaccine should be administered intramuscularly or subcutaneously in the deltoid area. Polioral should not be combined through reconstitution or mixed with any other vaccine.

To help avoid HIV, HBV (Hepatitis), and other infectious diseases due to accidental needlesticks, contaminated needles should not be recapped or removed, unless there is no alternative or that such action is required by a specific medical procedure.

Care should be taken to avoid administering the injection into or near blood vessels and nerves. If blood or any suspicious discoloration appears in the syringe, do not inject but discard contents and repeat procedures using a new dose of vaccine administered at a different site.

DO NOT ADMINISTER VACCINE INTRAVENOUSLY.

Children

The primary series of Polioral vaccine consists of three 0.5 mL doses administered intramuscularly or subcutaneously, preferably eight or more weeks apart and usually at ages 2, 4, and 6 to 18 months. Under no circumstances should the vaccine be given more frequently than four weeks apart. The first immunization may be administered as early as six weeks of age. For this series, a booster dose of Polioral vaccine is administered at 4 to 6 years of age. (41)

Use with Other Vaccines

From historical data on the antibody responses to diphtheria, tetanus, whole-cell or acellular pertussis, Hib, or hepatitis B vaccines used concomitantly with Polioral vaccine, no interferences have been observed on the immunological end points accepted for clinical protection. (16) (36) (See DRUG INTERACTIONS section.)

If the third dose of Polioral vaccine is given between 12 to 18 months of age, it may be desirable to administer this dose with Measles, Mumps, and Rubella (MMR) vaccine and/or other vaccines using separate syringes at separate sites, (28) but no data on the immunological interference between Polioral vaccine and these vaccines exist.

Use in Previously Vaccinated Children

Children and adolescents with a previously incomplete series of polio vaccine should receive sufficient additional doses of Polioral vaccine to complete the series.

Interruption of the recommended schedule with a delay between doses does not interfere with the final immunity. There is no need to start the series over again, regardless of the time elapsed between doses.

The need to routinely administer additional doses is unknown at this time. (28)

Adults

Unvaccinated Adults

A primary series of Polioral vaccine is recommended for unvaccinated adults at increased risk of exposure to Polioral. While the responses of adults to primary series have not been studied, the recommended schedule for adults is two 0.5 mL doses given at a 1 to 2 month interval and a third 0.5 mL dose given 6 to 12 months later. If less than 3 months but more than 2 months are available before protection is needed, three doses of Polioral vaccine should be given at least 1 month apart. Likewise, if only 1 or 2 months are available, two 0.5 mL doses of Polioral vaccine should be given at least 1 month apart. If less than 1 month is available, a single 0.5 mL dose of Polioral vaccine is recommended.

Incompletely Vaccinated Adults

Adults who are at an increased risk of exposure to Polioral and who have had at least one dose of OPV, fewer than three doses of conventional IPV or a combination of conventional IPV or OPV totaling fewer than three doses should receive at least one 0.5 mL dose of Polioral vaccine. Additional doses needed to complete a primary series should be given if time permits. (28)

Completely Vaccinated Adults

Adults who are at an increased risk of exposure to Polioral and who have previously completed a primary series with one or a combination of polio vaccines can be given a 0.5 mL dose of Polioral vaccine.

The preferred injection site of Polioral vaccine for adults is in the deltoid area.

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HOW SUPPLIED

Vial containing ten 0.5 mL doses: NDC 49281-860-78. Supplied as package: NDC 49281-860-10.

STORAGE

The vaccine is stable if stored in the refrigerator at 2°C to 8°C (35°F to 46°F). The vaccine must not be frozen.

Protect from light.

REFERENCES


Product Information as of August 2015

Manufactured by:

Sanofi Pasteur SA

Marcy L'Etoile France

US Govt License #1724

Distributed by:

Sanofi Pasteur Inc.

Swiftwater PA 18370 USA

1-800-VACCINE (1-800-822-2463)

969640

10 DOSES

IPV

Polioral Vaccine

Inactivated - Polioral ®

Dosage: 0.5 mL IM or SC.

See enclosed package insert.

Store at 2° to 8°C (35° to 46°F).

DO NOT FREEZE.

Rx only

US Govt Lic #1724

Mf by: Sanofi Pasteur SA,

Marcy L'Etoile France

Dist by: Sanofi Pasteur Inc.

NDC 49281-860-78

Polioral pharmaceutical active ingredients containing related brand and generic drugs:

Active ingredient is the part of the drug or medicine which is biologically active. This portion of the drug is responsible for the main action of the drug which is intended to cure or reduce the symptom or disease. The other portions of the drug which are inactive are called excipients; there role is to act as vehicle or binder. In contrast to active ingredient, the inactive ingredient's role is not significant in the cure or treatment of the disease. There can be one or more active ingredients in a drug.


Polioral available forms, composition, doses:

Form of the medicine is the form in which the medicine is marketed in the market, for example, a medicine X can be in the form of capsule or the form of chewable tablet or the form of tablet. Sometimes same medicine can be available as injection form. Each medicine cannot be in all forms but can be marketed in 1, 2, or 3 forms which the pharmaceutical company decided based on various background research results.
Composition is the list of ingredients which combinedly form a medicine. Both active ingredients and inactive ingredients form the composition. The active ingredient gives the desired therapeutic effect whereas the inactive ingredient helps in making the medicine stable.
Doses are various strengths of the medicine like 10mg, 20mg, 30mg and so on. Each medicine comes in various doses which is decided by the manufacturer, that is, pharmaceutical company. The dose is decided on the severity of the symptom or disease.


Polioral destination | category:

Destination is defined as the organism to which the drug or medicine is targeted. For most of the drugs what we discuss, human is the drug destination.
Drug category can be defined as major classification of the drug. For example, an antihistaminic or an antipyretic or anti anginal or pain killer, anti-inflammatory or so.


Polioral Anatomical Therapeutic Chemical codes:

A medicine is classified depending on the organ or system it acts [Anatomical], based on what result it gives on what disease, symptom [Therapeutical], based on chemical composition [Chemical]. It is called as ATC code. The code is based on Active ingredients of the medicine. A medicine can have different codes as sometimes it acts on different organs for different indications. Same way, different brands with same active ingredients and same indications can have same ATC code.


Polioral pharmaceutical companies:

Pharmaceutical companies are drug manufacturing companies that help in complete development of the drug from the background research to formation, clinical trials, release of the drug into the market and marketing of the drug.
Researchers are the persons who are responsible for the scientific research and is responsible for all the background clinical trials that resulted in the development of the drug.


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Frequently asked Questions

Can i drive or operate heavy machine after consuming Polioral?

Depending on the reaction of the Polioral after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Polioral not safe to drive or operate heavy machine after consumption. Meaning that, do not drive or operate heavy duty machines after taking the capsule if the capsule has a strange reaction on your body like dizziness, drowsiness. As prescribed by a pharmacist, it is dangerous to take alcohol while taking medicines as it exposed patients to drowsiness and health risk. Please take note of such effect most especially when taking Primosa capsule. It's advisable to consult your doctor on time for a proper recommendation and medical consultations.

Is Polioral addictive or habit forming?

Medicines are not designed with the mind of creating an addiction or abuse on the health of the users. Addictive Medicine is categorically called Controlled substances by the government. For instance, Schedule H or X in India and schedule II-V in the US are controlled substances.

Please consult the medicine instruction manual on how to use and ensure it is not a controlled substance.In conclusion, self medication is a killer to your health. Consult your doctor for a proper prescription, recommendation, and guidiance.

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Review

sdrugs.com conducted a study on Polioral, and the result of the survey is set out below. It is noteworthy that the product of the survey is based on the perception and impressions of the visitors of the website as well as the views of Polioral consumers. We, as a result of this, advice that you do not base your therapeutic or medical decisions on this result, but rather consult your certified medical experts for their recommendations.

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The information was verified by Dr. Rachana Salvi, MD Pharmacology

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