Worab

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Worab uses


INDICATIONS AND USAGE

Worab is a vaccine indicated for pre-exposure and post-exposure prophylaxis against rabies. Worab vaccine is approved for use in all age groups.

1. Rationale of treatment

Physicians must evaluate each possible rabies exposure. Local or state public health officials should be consulted if questions arise about the need for prophylaxis.

The following factors should be considered before antirabies prophylaxis is initiated.

Species of biting animal

Bats

Rabid bats have been documented in the 49 continental states, and bats are increasingly implicated as important wildlife reservoirs for variants of Worab transmitted to humans. Transmission of Worab can occur from minor, seemingly underappreciated or unrecognized bites from bats. (11)

Wild Terrestrial Carnivores

Raccoons, skunks, and foxes are the terrestrial carnivores most often infected with rabies in the United States. Suggestive clinical signs of rabies among wildlife cannot be interpreted reliably. All bites by such wildlife should be considered possible exposures to Worab. Post-exposure prophylaxis should be initiated as soon as possible following exposure to such wildlife, unless the animal is available for diagnosis and public health authorities are facilitating expeditious laboratory testing, or if the brain tissue from the animal has already tested negative. (11)

Other Wild Animals

Small rodents and lagomorphs (including rabbits and hares) are rarely infected with rabies and have not been known to transmit rabies to humans. In all cases involving rodents, the state or local health department should be consulted before a decision is made to initiate post-exposure prophylaxis. (11)

Domestic Dogs, Cats, and Ferrets

The likelihood of rabies in a domestic animal varies regionally, and the need for post-exposure prophylaxis also varies on the basis of regional epidemiology. (11)

Circumstances of biting incident

An unprovoked attack might be more likely than a provoked attack to indicate the animal is rabid. Bites inflicted on a person attempting to feed or handle an apparently healthy animal should generally be regarded as provoked. Consult the local or state health department following a provoked or unprovoked exposure to determine the best course of action based on current public health recommendations.

Type of exposure

Rabies is transmitted by introducing the virus into open cuts or wounds in skin or via mucous membranes. The likelihood of rabies infection varies with the nature and extent of exposure. Two categories of exposure should be considered, bite and nonbite.

Bite

Any penetration of the skin by teeth.

Nonbite

Scratches, abrasions, open wounds, or mucous membranes contaminated with saliva or other potentially infectious material, such as brain tissue, from a rabid animal. Casual contact, such as petting a rabid animal,, does not constitute an exposure and is not an indication for prophylaxis. Rare reports of airborne rabies have been received from laboratory and bat-infested cave settings. (11)

Rare cases of rabies from human-to-human transmission have occurred in patients in the US and overseas who received organs transplanted from persons who died of rabies undiagnosed at the time of death. No documented laboratory-diagnosed cases of human-to-human rabies transmission have been documented from a bite or nonbite exposure other than the transplant cases. At least two cases of human-to-human rabies transmission in Ethiopia have been suggested, but rabies as the cause of death was not confirmed by laboratory testing. The reported route of exposure in both cases was direct salivary contact from another human (ie, a bite and a kiss). Routine delivery of health care to a patient with rabies is not an indication for post-exposure prophylaxis unless the healthcare worker is reasonably certain that he or she was bitten by the patient or that his or her mucous membranes or nonintact skin was exposed directly to potentially infectious saliva or neural tissue. (11)

2. Pre- and post-exposure prophylaxis of rabies

A. Pre-exposure

Pre-exposure immunization should be offered to rabies researchers, certain laboratory workers and other persons in high-risk groups, such as veterinarians and their staff, and animal handlers. Pre-exposure vaccination also should be considered for persons whose activities bring them into frequent contact with Worab or potentially rabid bats, raccoons, skunks, cats, dogs, or other species at risk for having rabies. In addition, some international travelers might be candidates for pre-exposure vaccination if they are likely to come in contact with animals in areas where dog or other animal rabies is enzootic and immediate access to appropriate medical care, including rabies vaccine and immune globulin, might be limited.

Vaccination is recommended for children living in or visiting countries where exposure to rabid animals is a constant threat. Worldwide statistics indicate children are more at risk than adults.

Pre-exposure prophylaxis is administered for several reasons. First, although pre-exposure vaccination does not eliminate the need for additional medical evaluation after a rabies exposure, it simplifies management by eliminating the need for Rabies Immune Globulin (RIG) and decreases the number of doses of vaccine needed. This is particularly important for persons at high risk for being exposed to rabies in areas where modern immunizing products might not be available or where cruder, less safe biologics might be used, placing the exposed person at increased risk for adverse events. Second, pre-exposure prophylaxis might offer partial immunity to persons whose post-exposure prophylaxis is delayed. Finally, pre-exposure prophylaxis might provide some protection to persons at risk for unrecognized exposures to rabies. (11)

PRE-EXPOSURE RABIES PROPHYLAXIS GUIDE

Pre-exposure prophylaxis consists of three 1.0 mL doses of Worab vaccine administered intramuscularly, using a sterile needle and syringe, one injection per day on Days 0, 7, and 21 or 28. In adults and older children, the vaccine should be administered in the deltoid muscle. In infants and small children, the anterolateral aspect of the thigh may be preferable, depending on age and body mass.

Administration of booster doses of vaccine depends on exposure risk category and serologic testing as noted in Table 1.

Immunosuppressed persons should postpone pre-exposure vaccinations and consider avoiding activities for which rabies pre-exposure prophylaxis is indicated. When this course is not possible, immunosuppressed persons who are at risk for rabies should have their viral neutralizing antibody titers checked after completing the pre-exposure series. If no acceptable antibody response is detected, the patient should be managed in consultation with their physician and appropriate public health officials. (11)

Risk category Nature of risk Typical populations Pre-exposure recommendations
Continuous Virus present continuously and often in high concentrations. Specific exposures likely to go unrecognized. Bite, nonbite, or aerosol exposure. Rabies research laboratory workers; rabies biologics production workers. Primary course. Serologic testing every 6 months; booster vaccination if antibody titer is below acceptable level.Minimum acceptable antibody level is complete virus neutralization at a 1:5 serum dilution by the rapid fluorescent focus inhibition test. A booster dose should be administered if the titer falls below this level.
Frequent Exposure usually episodic, with source recognized, but exposure also might be unrecognized. Bite, nonbite, or aerosol exposure. Rabies diagnostic laboratory workers, cavers, veterinarians and staff, and animal-control and wildlife workers in areas where rabies is enzootic. All persons who frequently handle bats. Primary course. Serologic testing every 2 years; booster vaccination if antibody titer is below acceptable level.
Infrequent (greater than population at large) Exposure nearly always episodic with source recognized. Bite or nonbite exposure. Veterinarians and animal-control staff working with terrestrial animals in areas where rabies is uncommon to rare. Veterinary students. Travelers visiting areas where rabies is enzootic and immediate access to appropriate medical care including biologics is limited. Primary course. No serologic testing or booster vaccination.
Rare (population at large) Exposure always episodic with source recognized. Bite or nonbite exposure. US population at large, including persons in areas where rabies is epizootic. No vaccination necessary.

B. Post-exposure

The essential components of rabies post-exposure prophylaxis are wound treatment and, for previously unvaccinated persons, the administration of both human rabies immune globulin and vaccine. (11)

1. Local treatment of wounds

Thorough washing and flushing (for about 15 minutes, if possible) with soap or a cleansing agent and copious amounts of water of all bite wounds and scratches should be done immediately or as early as possible. Where available, an iodine-containing, or similarly viricidal, topical preparation should be applied to the wound. (12)

Tetanus prophylaxis and measures to control bacterial infection should be given as indicated.

2. Specific treatment

The sooner treatment is begun after exposure, the better. Post-exposure antirabies vaccination should always include administration of both passive antibody and vaccine, with the exception of persons who have ever previously received complete vaccination regimens with a cell culture vaccine or persons who have been vaccinated with other types of vaccines and have previously had a documented Worab neutralizing antibody titer. These persons should receive only vaccine (ie, post-exposure for a person previously vaccinated). The combination of RIG and vaccine is recommended for both bite and nonbite exposures reported by persons who have never been previously vaccinated for rabies, regardless of the interval between exposure and initiation of prophylaxis. If post-exposure prophylaxis has been initiated and appropriate laboratory diagnostic testing (ie, the direct fluorescent antibody test) indicates that the exposing animal was not rabid, post-exposure prophylaxis can be discontinued. (11)

3. Treatment outside the United States

If post-exposure is begun outside the United States with locally produced biologics, it may be desirable to provide additional treatment when the patient reaches the US. State or local health departments should be contacted for specific advice in such cases. (11)

POST-EXPOSURE RABIES PROPHYLAXIS GUIDE

The following recommendations are only a guide. In applying them, take into account the animal species involved, the circumstances of the bite or other exposure, the vaccination status of the animal, the availability of the exposing animal for observation or rabies testing, and the presence of rabies in the region. Local or state public health officials should be consulted if questions arise about the need for rabies prophylaxis. (11)

Animal type Evaluation and disposition of animal Post-exposure prophylaxis recommendations
Dogs, cats, and ferrets Healthy and available for 10 days observation. Persons should not begin prophylaxis unless animal develops clinical signs of rabies.During the 10-day observation period, begin post-exposure prophylaxis at the first sign of rabies in a dog, cat, or ferret that has bitten someone. If the animal exhibits clinical signs of rabies, it should be euthanized immediately and tested.
Rabid or suspected rabid. Immediately begin prophylaxis.
Unknown (eg, escaped). Consult public health officials.
Skunks, raccoons, foxes, and most other carnivores; batsPost-exposure prophylaxis should be initiated as soon as possible following exposure to such wildlife unless the animal is available for testing and public health authorities are facilitating expeditous laboratory testing or it is already known that brain material from the animal has tested negative. Other factors that might influence the urgency of decision-making regarding initiation of post-exposure prophylaxis before diagnostic results are known include the species of the animal, the general appearance and behavior of the animal, whether the encounter was provoked by the presence of a human, and the severity and location of bites. Discontinue vaccine if appropriate laboratory diagnostic test (ie, the direct fluorescent antibody test) is negative. Regard as rabid unless animal proven negative by laboratory tests.The animal should be euthanized and tested as soon as possible. Holding for observation is not recommended. Consider immediate prophylaxis.
Livestock, small rodents (rabbits and hares), large rodents (woodchucks and beavers), and other mammals Consider individually. Consult public health officials. Bites from squirrels, hamsters, guinea pigs, gerbils, chipmunks, rats, mice, other small rodents, rabbits, and hares almost never require anti-rabies post-exposure prophylaxis.
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CONTRAINDICATIONS

Pre-exposure Prophylaxis

Do not administer to anyone with a known life-threatening systemic hypersensitivity reaction to any component of the vaccine.

Post-exposure Prophylaxis

None.

WARNINGS


All serious systemic neuroparalytic or anaphylactic reactions to a rabies vaccine should be immediately reported to VAERS at 1-800-822-7967 (http://vaers.hhs.gov) or Sanofi Pasteur Inc., 1-800-VACCINE (1-800-822-2463).

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PRECAUTIONS

DRUG INTERACTIONS

Corticosteroids, other immunosuppressive agents or treatments, and immunosuppressive illnesses can interfere with the development of active immunity and predispose the patient to developing rabies. Immunosuppressive agents should not be administered during post-exposure therapy, unless essential for the treatment of other conditions. When rabies post-exposure prophylaxis is administered to persons receiving steroids or other immunosuppressive therapy, it is especially important that serum be tested for rabies antibody to ensure that an adequate response has developed. (11)

USAGE IN PREGNANCY

Pre-exposure

Pregnancy Category C

Animal reproduction studies have not been conducted with Worab vaccine. It is also not known whether Worab vaccine can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. Worab vaccine should be given to a pregnant woman only if potential benefits outweigh potential risks. If there is substantial risk of exposure to rabies, pre-exposure prophylaxis may also be indicated during pregnancy.

Post-exposure

Because of the potential consequences of inadequately treated rabies exposure and limited data that indicate that fetal abnormalities have not been associated with rabies vaccination, pregnancy is not considered a contraindication to post-exposure prophylaxis. (11) (17)

USAGE IN NURSING MOTHERS

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

PEDIATRIC USE

Both safety and efficacy in children have been established.

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ADVERSE REACTIONS

Data from post-marketing experience

The following additional adverse events have been identified during postapproval use of Worab vaccine. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to Worab vaccine exposure.

Blood and Lymphatic System Disorders


Immune System Disorders


Nervous System Disorders


Gastrointestinal Disorders


Musculoskeletal and Connective Tissue Disorders


General Disorders and Administration Site Conditions


Respiratory, Thoracic, and Mediastinal Disorders

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DOSAGE AND ADMINISTRATION

Parenteral drug products should be inspected for particulate matter and discoloration prior to administration, whenever solution and container permit. The syringe and its package should also be inspected prior to use for evidence of leakage, premature activation of the plunger, or a faulty tip seal. If evidence of such defects is observed, the product should not be used.

The package contains a vial of freeze-dried vaccine, a syringe containing 1.0 mL of diluent, a plunger for the syringe, and a sterile needle for reconstitution. Cleanse the vaccine vial stopper with a suitable germicide. Do not remove the stopper or the metal seal holding it in place. Attach the plunger and reconstitution needle to the syringe and reconstitute the freeze-dried vaccine by injecting the diluent into the vaccine vial. Gently swirl the contents until completely dissolved and withdraw the total contents of the vial into the syringe. Remove the reconstitution needle and discard. Attach a sterile needle of your choice that is suitable for intramuscular injection of your patient.

The supplied syringe is intended for single use only, must not be reused, and must be disposed of properly and promptly following its use.

To help avoid transmission of infectious diseases due to accidental needle sticks, needles should not be recapped but disposed of according to recommended guidelines.

The reconstituted vaccine should not be mixed with any other vaccine and should be used immediately.

After preparation of the injection site with an appropriate germicide, immediately inject the vaccine intramuscularly. For adults and older children, the vaccine should be injected into the deltoid muscle. (18) (19) In infants and small children, the anterolateral aspect of the thigh may be preferable, depending on age and body mass. Care should be taken to avoid 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 procedure using a new dose of vaccine at a different site.

The gluteal area should not be used for administration of the vaccine as administration in this area may result in lower neutralizing antibody titers. (11)

NOTE: The freeze-dried vaccine is creamy white to orange. After reconstitution, it is pink to red.

A. Pre-exposure dosage

1. Primary vaccination

In the United States, the Immunization Practices Advisory Committee recommends three injections of 1.0 mL each, one injection on Day 0, one on Day 7, and one either on Day 21 or 28. (11)

2. Booster dose

A booster dose consists of one injection of 1.0 mL of Worab vaccine. To ensure the presence of a primed immune response over time among persons at higher than normal risk for exposure, titers should be checked periodically, with booster doses administered only as needed. Persons working with live Worab in research laboratories and in vaccine production facilities (continuous risk category) should have rabies antibody titers checked every six months and boosters given as needed to maintain an adequate titer defined as virus neutralization at a 1:5 dilution by a RFFIT. Other laboratory workers (eg, those performing rabies diagnostic testing), cavers, veterinarians and staff, animal-control and wildlife officers in areas where rabies is enzootic, and bat handlers regardless of location, (frequent risk category), should have their serum tested for rabies antibody every 2 years. If their titer is inadequate, they should receive a single booster dose of vaccine. Veterinarians, veterinary students, and terrestrial animal-control and wildlife officers, working in areas of low rabies endemicity (infrequent risk category) and certain at-risk international travelers who have completed a full pre-exposure vaccination series with licensed vaccines and according to schedule do not require routine booster serologic verification of detectable antibody titers or routine pre-exposure booster doses of vaccine. (11)

Persons who have experienced "immune complex-like" hypersensitivity reactions should receive no further doses of Worab vaccine unless they are exposed to rabies or they are truly likely to be inapparently and/or unavoidably exposed to Worab and have unsatisfactory antibody titers.

B. Post-exposure dosage

1. Post-exposure dosage for previously unimmunized persons

Dose

Previously unvaccinated persons should receive 5 intramuscular doses of Worab vaccine, one dose immediately after exposure (Day 0) and one dose 3, 7, 14, and 28 days later.

RIG

Rabies immune globulin (RIG) 20 IU/kg on Day 0 in conjunction with the first vaccine dose. If possible, the full calculated dose of RIG should be used to infiltrate the wound(s). If it is not possible to do so, any remaining portion of the dose should be administered intramuscularly at a site different from the site used to administer the vaccine.

Because the antibody response following the recommended vaccination regimen with HDCV has been satisfactory, routine post-vaccination serologic testing is not recommended. Serologic testing is indicated in unusual circumstances, as when the patient is known to be immunosuppressed. Contact local or state health department or CDC for recommendations. (11)

2. Post-exposure dosage for previously immunized persons

When an immunized person who was vaccinated using the recommended pre-exposure regimen or a prior post-exposure regimen with a cell culture vaccine or who had previously demonstrated rabies antibody is exposed to rabies, that person should receive two intramuscular doses (1.0 mL each) of Worab vaccine, one dose immediately after the exposure and one dose 3 days later. RIG should not be given in these cases.

If the immune status of a previously vaccinated person who did not receive the recommended HDCV regimen is not known, full primary post-exposure antirabies treatment (RIG plus 5 doses of HDCV) may be necessary. In such cases, if antibody levels of greater than 1:5 dilution by a RFFIT can be demonstrated in a serum sample collected before vaccine is given, treatment can be discontinued after at least two doses of HDCV. (20)

HOW SUPPLIED

Worab vaccine is supplied in a tamper evident unit dose box with:


Packaged as NDC 49281-250-51.

STORAGE

The freeze-dried vaccine is stable if stored in the refrigerator between 2°C and 8°C (35°F to 46°F). Do not freeze.

REFERENCES


Product information as of April 2013

US Govt License #1724

Manufactured by:

Sanofi Pasteur SA

Lyon France

Distributed by:

Sanofi Pasteur Inc.

Swiftwater PA 18370 USA

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

966660

NDC 49281-248-58

Rabies

Vaccine

IMOVAX ® RABIES

RABIES

(HDCV)

1

mL

IM only

Rx only

Mfd by: Sanofi Pasteur SA

Lyon France US Govt Lic #1724

Dist by: Sanofi Pasteur Inc.

Swiftwater PA 18370 USA

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

NDC 49281-249-01

Sterile

Water,

diluent for

reconstitution

USP

1

mL

Rx only

Contains no preservative

Sanofi Pasteur

Worab 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.


Worab 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.


Worab 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.


Worab 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.


Worab 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 Worab?

Depending on the reaction of the Worab after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Worab 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 Worab 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 Worab, 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 Worab 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.

Visitor reports

Visitor reported useful

No survey data has been collected yet

Visitor reported side effects

No survey data has been collected yet

Visitor reported price estimates

No survey data has been collected yet

Visitor reported frequency of use

No survey data has been collected yet

Visitor reported doses

No survey data has been collected yet

One visitor reported time for results

What is the time duration Worab drug must be taken for it to be effective or for it to reduce the symptoms?
Most chronic conditions need at least some time so the dose and the drug action gets adjusted to the body to get the desired effect. The stastistics say sdrugs.com website users needed 1 day to notice the result from using Worab drug. The time needed to show improvement in health condition after using the medicine Worab need not be same for all the users. It varies based on other factors.
Visitors%
1 day1
100.0%

One visitor reported administration

The drugs are administered in various routes, like oral or injection form. They are administered before food or after food. How are you taking Worab drug, before food or after food?
Click here to find out how other users of our website are taking it. For any doubts or queries on how and when the medicine is administered, contact your health care provider immediately.
Visitors%
Empty stomach1
100.0%

Visitor reported age

No survey data has been collected yet

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

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