BayRab

What is the dose of the medication you are taking?
advertisement

BayRab uses


INDICATIONS AND USAGE

Rabies vaccine and HyperRAB S/D should be given to all persons suspected of exposure to rabies with one exception: persons who have been previously immunized with rabies vaccine and have a confirmed adequate rabies antibody titer should receive only vaccine. HyperRAB S/D should be administered as promptly as possible after exposure, but can be administered up to the eighth day after the first dose of vaccine is given.

Recommendations for use of passive and active immunization after exposure to an animal suspected of having rabies have been detailed by the U.S. Public Health Service Advisory Committee on Immunization Practices. [19]

Every exposure to possible rabies infection must be individually evaluated. The following factors should be considered before specific antirabies treatment is initiated:

1. Species of Biting Animal

Carnivorous wild animals (especially skunks, foxes, coyotes, raccoons, and bobcats) and bats are the animals most commonly infected with rabies and have caused most of the indigenous cases of human rabies in the United States since 1960. [20] Unless the animal is tested and shown not to be rabid, postexposure prophylaxis should be initiated upon bite or nonbite exposure to these animals. If treatment has been initiated and subsequent testing in a competent laboratory shows the exposing animal is not rabid, treatment can be discontinued.

In the United States, the likelihood that a domestic dog or cat is infected with rabies varies from region to region; hence, the need for postexposure prophylaxis also varies. However, in most of Asia and all of Africa and Latin America, the dog remains the major source of human exposure; exposures to dogs in such countries represent a special threat. Travelers to those countries should be aware that >50% of the rabies cases among humans in the United States result from exposure to dogs outside the United States.

Rodents (such as squirrels, hamsters, guinea pigs, gerbils, chipmunks, rats, and mice) and lagomorphs (including rabbits and hares) are rarely found to be infected with rabies and have not been known to cause human rabies in the United States. However, from 1971 through 1988, woodchucks accounted for 70% of the 179 cases of rabies among rodents reported to CDC. [21] In these cases, the state or local health department should be consulted before a decision is made to initiate postexposure antirabies prophylaxis.

2. Circumstances of Biting Incident

An unprovoked attack is more likely to mean that the animal is rabid.

3. Type of Exposure

Rabies is transmitted only when the virus is introduced into open cuts or wounds in skin or mucous membranes. If there has been no exposure (as described in this section), postexposure treatment is not necessary. Thus, the likelihood that rabies infection will result from exposure to a rabid animal varies with the nature and extent of the exposure. Two categories of exposure should be considered:

Bite: any penetration of the skin by teeth. Bites to the face and hands carry the highest risk, but the site of the bite should not influence the decision to begin treatment. [22]

Bat-associated strains of rabies can be transmitted to humans either directly through a bat's bite or indirectly through the bite of an animal previously infected by a bat. Because some bat bites may be less severe, and can go completely undetected, unlike bites inflicted by larger animals, especially mammalian carnivores, rabies postexposure treatment should be considered for any physical contact with bats when bite or mucous membrane contact cannot be excluded. [23]

Nonbite: scratches, abrasions, open wounds or mucous membranes contaminated with saliva or any potentially infectious material, such as brain tissue, from a rabid animal constitute nonbite exposures. If the material containing the virus is dry, the virus can be considered noninfectious. Casual contact, such as petting a rabid animal and contact with the blood, urine, or feces (e.g., guano) of a rabid animal, does not constitute an exposure and is not an indication for prophylaxis. Instances of airborne rabies have been reported rarely. Adherence to respiratory precautions will minimize the risk of airborne exposure. [24]

The only documented cases of rabies from human-to-human transmission have occurred in patients who received corneas transplanted from persons who died of rabies undiagnosed at the time of death. Stringent guidelines for acceptance of donor corneas have reduced this risk.

Bite and nonbite exposures from humans with rabies theoretically could transmit rabies, although no cases of rabies acquired this way have been documented.

4. Vaccination Status of Biting Animal

A properly immunized animal has only a minimal chance of developing rabies and transmitting the virus.

5. Presence of Rabies in Region

If adequate laboratory and field records indicate that there is no rabies infection in a domestic species within a given region, local health officials are justified in considering this in making recommendations on antirabies treatment following a bite by that particular species. Such officials should be consulted for current interpretations.

Rabies Postexposure Prophylaxis

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, and presence of rabies in the region. Local or state public health officials should be consulted if questions arise about the need for rabies prophylaxis.

Local Treatment of Wounds: Immediate and thorough washing of all bite wounds and scratches with soap and water is perhaps the most effective measure for preventing rabies. In experimental animals, simple local wound cleansing has been shown to reduce markedly the likelihood of rabies.

Animal species Condition of animal

at time of exposure/attack

Treatment of

exposed person ALL POSTEXPOSURE PROPHYLAXIS SHOULD BEGIN WITH IMMEDIATE THOROUGH CLEANSING OF THE WOUND (IF ONE CAN BE DETECTED) WITH SOAP AND WATER. If antirabies treatment is indicated, both BayRab (Human) [RIGH] and human diploid cell rabies vaccine (HDCV) should be given as soon as possible, REGARDLESS of the interval from exposure.

Dog and cat Healthy and available for 10 days of observation None, unless animal develops rabiesDuring the usual holding period of 10 days, begin postexposure prophylaxis at first sign of rabies in a dog or cat that has bitten someone. If the animal exhibits clinical signs of rabies, it should be euthanized immediately and tested.
Rabid or suspected rabid RIGHIf RIGH is not available, use antirabies serum, equine (ARS). Do not use more than the recommended dosage. and HDCV
Unknown (escaped) Consult public health officials
Skunk, bat, fox, coyote,

raccoon, bobcat, and

other carnivores; woodchuck

Regard as rabid unless animal proven negative by laboratory testsThe animal should be euthanized and tested as soon as possible. Holding for observation is not recommended. Discontinue vaccine if immunofluorescence test results of the animal are negative. RIGH and HDCV
Livestock, rodents, and

lagomorphs (rabbits and hares)

Consider individually. Local and state public health officials should be consulted on questions about the need for rabies prophylaxis. In most geographical areas bites of squirrels, hamsters, guinea pigs, gerbils, chipmunks, rats, mice, other rodents, rabbits, and hares almost never require antirabies postexposure prophylaxis.
advertisement

CONTRAINDICATIONS

None known.

WARNINGS

BayRab (Human) - HyperRAB® S/D is made from human plasma. Products made from human plasma may contain infectious agents, such as viruses, and, theoretically, the Creutzfeldt-Jakob Disease (CJD) agent that can cause disease. The risk that such products will transmit an infectious agent has been reduced by screening plasma donors for prior exposure to certain viruses, by testing for the presence of certain current virus infections, and by inactivating and/or removing certain viruses. Despite these measures, such products can still potentially transmit disease. There is also the possibility that unknown infectious agents may be present in such products. Individuals who receive infusions of blood or plasma products may develop signs and/or symptoms of some viral infections, particularly hepatitis C. ALL infections thought by a physician possibly to have been transmitted by this product should be reported by the physician or other healthcare provider to Grifols Therapeutics Inc. [1-800-520-2807].

The physician should discuss the risks and benefits of this product with the patient, before prescribing or administering it to the patient.

HyperRAB S/D should be given with caution to patients with a history of prior systemic allergic reactions following the administration of human immunoglobulin preparations.

The attending physician who wishes to administer HyperRAB S/D to persons with isolated immunoglobulin A (IgA) deficiency must weigh the benefits of immunization against the potential risks of hypersensitivity reactions. Such persons have increased potential for developing antibodies to IgA and could have anaphylactic reactions to subsequent administration of blood products that contain IgA. [25]

As with all preparations administered by the intramuscular route, bleeding complications may be encountered in patients with thrombocytopenia or other bleeding disorders.

advertisement

PRECAUTIONS

General

HyperRAB S/D should not be administered intravenously because of the potential for serious reactions. Although systemic reactions to immunoglobulin preparations are rare, epinephrine should be available for treatment of acute anaphylactoid symptoms.

Drug Interactions

Repeated doses of HyperRAB S/D should not be administered once vaccine treatment has been initiated as this could prevent the full expression of active immunity expected from the rabies vaccine.

Other antibodies in the HyperRAB S/D preparation may interfere with the response to live vaccines such as measles, mumps, polio or rubella. Therefore, immunization with live vaccines should not be given within 3 months after HyperRAB S/D administration.

Pregnancy Category C

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

Pediatric Use

Safety and effectiveness in the pediatric population have not been established.

ADVERSE REACTIONS

Soreness at the site of injection and mild temperature elevations may be observed at times. Sensitization to repeated injections has occurred occasionally in immunoglobulin-deficient patients. Angioneurotic edema, skin rash, nephrotic syndrome, and anaphylactic shock have rarely been reported after intramuscular injection, so that a causal relationship between immunoglobulin and these reactions is not clear.

advertisement

DOSAGE AND ADMINISTRATION

The recommended dose for HyperRAB S/D is 20 IU/kg (0.133 mL/kg) of body weight given preferably at the time of the first vaccine dose.[8,9] It may also be given through the seventh day after the first dose of vaccine is given. If anatomically feasible, up to the full dose of HyperRAB S/D should be thoroughly infiltrated in the area around the wound and the rest should be administered intramuscularly in the deltoid muscle of the upper arm or lateral thigh muscle. The gluteal region should not be used as an injection site because of the risk of injury to the sciatic nerve. [26] HyperRAB S/D should never be administered in the same syringe or needle or in the same anatomical site as vaccine.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

HDCV=human diploid cell vaccine; PCEC=purified chick embryo cell vaccine; RIG=rabies immune globulin; RVA=rabies vaccine adsorbed; IM, intramuscular
Vaccination status Treatment Regimen These regimens are applicable for all age groups, including children.
Not previously vaccinated Wound cleansing All postexposure treatment should begin with immediate thorough cleansing of all wounds with soap and water. If available, a virucidal agent such as a povidone-iodine solution should be used to irrigate the wounds.
RIG Administer 20 IU/kg body weight. If anatomically feasible, the full dose should be infiltrated around the wound(s) and any remaining volume should be administered IM at an anatomical site distant from vaccine administration.

Also, RIG should not be administered in the same syringe as vaccine. Because RIG might partially suppress active production of antibody, no more than the recommended dose should be given.

Vaccine HDCV, RVA, or PCEC 1.0 mL, IM (deltoid areaThe deltoid area is the only acceptable site of vaccination for adults and older children. For younger children, the outer aspect of the thigh may be used. Vaccine should never be administered in the gluteal area. ), one each on days 0Day 0 is the day the first dose of vaccine is administered., 3, 7, 14, and 28.
Previously vaccinatedAny person with a history of preexposure vaccination with HDCV, RVA, or PCEC; prior postexposure prophylaxis with HDCV, RVA, or PCEC; or previous vaccination with any other type of rabies vaccine and a documented history of antibody response to the prior vaccination. Wound cleansing All postexposure treatment should begin with immediate thorough cleansing of all wounds with soap and water. If available, a virucidal agent such as a povidone-iodine solution should be used to irrigate the wounds.
RIG RIG should not be administered.
Vaccine HDCV, RVA, or PCEC 1.0 mL, IM (deltoid area ), one each on days 0 and 3.
advertisement

HOW SUPPLIED

HyperRAB S/D is packaged in 2 mL and 10 mL single dose vials with an average potency value of 150 international units per mL (IU/mL). The 2 mL vial contains a total of 300 IU which is sufficient for a child weighing 15 kg. The 10 mL vial contains a total of 1500 IU which is sufficient for an adult weighing 75 kg. HyperRAB S/D is preservative-free and latex-free.

NDC Number Size
13533-618-02 2 mL vial
13533-618-10 10 mL vial

STORAGE

HyperRAB S/D should be stored under refrigeration (2–8°C, 36–46°F). Solution that has been frozen should not be used.

CAUTION

Rx only

U.S. federal law prohibits dispensing without prescription.

LIMITED WARRANTY

A number of factors could reduce the efficacy of this product or even result in an ill effect following its use. These include improper storage and handling of the product after it leaves our hands, diagnosis, dosage, method of administration, and biological differences in individual patients. Because of these factors, it is important that this product be stored properly and that the directions be followed carefully during use.

No warranty, express or implied, including any warranty of merchantability or fitness is made. Representatives of the Company are not authorized to vary the terms or the contents of the printed labeling, including the package insert for this product, except by printed notice from the Company’s headquarters. The prescriber and user of this product must accept the terms hereof.

REFERENCES


Grifols Therapeutics Inc.

Research Triangle Park, NC 27709 USA

U.S. License No. 1871

08941118

(Rev. September 2012)

BayRab (Human)


HyperRAB® S/D

Solvent/Detergent Treated

Preservative-free, latex-free

150 IU/mL Suitable for use with Rabies Vaccine

2 mL

NDC 13533-618-02

GRIFOLS

The patient and physician should discuss the risks and benefits of this product.

One Single Dose Vial

FOR INTRAMUSCULAR INJECTION ONLY. DO NOT GIVE INTRAVENOUSLY.

For complete dosage and administration information, read enclosed package insert.

Store at 2–8ºC (36–46ºF).

Do not freeze.

If the shrink band is absent or shows any sign of tampering, do not use the product and notify Grifols Therapeutics Inc. immediately.

Not returnable for credit or exchange.

Rx only

CAUTION: U.S. federal law prohibits dispensing without prescription.

BayRab (Human) is a sterile solution of immunoglobulin containing 15%–18% protein stabilized with 0.21–0.32 M glycine. The pH is adjusted with sodium carbonate.

The potency of each vial is 150 IU/mL based on the U.S. Standard BayRab.

Grifols Therapeutics Inc.

Research Triangle Park, NC 27709 USA

U.S. License No. 1871

Carton: 08941174

BayRab (Human)

HyperRAB® S/D

2 mL

Solvent/Detergent Treated

150 IU/ml

Grifols Therapeutics, Inc.

RTP, NC 27709 USA

U.S. License No. 1871

The patient and physician should discuss the risks and benefits of this product.

Dosage & Administration: See insert.

3036918

Lot/Exp.

BayRab (Human)


HyperRAB® S/D

Solvent/Detergent Treated

Preservative-free, latex-free

150 IU/mL Suitable for use with Rabies Vaccine

10 mL

NDC 13533-618-10

The patient and physician should discuss the risks and benefits of this product.

One Single Dose Vial

FOR INTRAMUSCULAR INJECTION ONLY. DO NOT GIVE INTRAVENOUSLY.

For complete dosage and administration information, read enclosed package insert.

Store at 2–8ºC (36–46ºF).

Do not freeze.

If the shrink band is absent or shows any sign of tampering, do not use the product and notify Grifols Therapeutics Inc. immediately.

Not returnable for credit or exchange.

Rx only

CAUTION: U.S. federal law prohibits dispensing without prescription.

BayRab (Human) is a sterile solution of immunoglobulin containing 15%–18% protein stabilized with 0.21–0.32 M glycine. The pH is adjusted with sodium carbonate.

The potency of each vial is 150 IU/mL based on the U.S. Standard BayRab.

Grifols Therapeutics Inc.

Research Triangle Park, NC 27709 USA

U.S. License No. 1871

Carton: 08940719

NDC 13533-618-11

BayRab (Human)

HyperRAB® S/D

10 mL

Solvent/Detergent Treated


Grifols Therapeutics, Inc.

RTP, NC 27709 USA

U.S. License No. 1871

The patient and physician should discuss the risks and benefits of this product.

One Single Dose Vial

150 IU/mL

Do not give intravenously.

Dosage: 20 IU/kg in conjunction with Rabies Vaccine.

See directions before using.

Rx only

3036921

Lot/Exp.

BayRab 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.


BayRab 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.


BayRab 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.


BayRab 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.


BayRab 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.


advertisement

References

  1. Dailymed."HYPERRAB S/D (RABIES IMMUNE GLOBULIN (HUMAN)) INJECTION [GRIFOLS USA, LLC]". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).

Frequently asked Questions

Can i drive or operate heavy machine after consuming BayRab?

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

advertisement

Review

sdrugs.com conducted a study on BayRab, 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 BayRab 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

Visitor reported time for results

No survey data has been collected yet

Visitor reported administration

No survey data has been collected yet

Visitor reported age

No survey data has been collected yet

Visitor reviews


There are no reviews yet. Be the first to write one!


Your name: 
Email: 
Spam protection:  < Type 19 here

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

© 2002 - 2022 "sdrugs.com". All Rights Reserved