Inmunogamma Antitet

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Inmunogamma Antitet uses

• Indications and usage
• Contraindications
• Warnings
• Precautions
• Adverse reactions
• Overdosage
• Dosage and administration
• How supplied
• Storage
• Caution
• References
• Inmunogamma Antitet reviews

INDICATIONS AND USAGE

HyperTET S/D is indicated for prophylaxis against tetanus following injury in patients whose immunization is incomplete or uncertain. It is also indicated, although evidence of effectiveness is limited, in the regimen of treatment of active cases of tetanus. [7,8,15]

A thorough attempt must be made to determine whether a patient has completed primary vaccination. Patients with unknown or uncertain previous vaccination histories should be considered to have had no previous tetanus toxoid doses. Persons who had military service since 1941 can be considered to have received at least one dose, and although most of them may have completed a primary series of tetanus toxoid, this cannot be assumed for each individual. Patients who have not completed a primary series may require tetanus toxoid and passive immunization at the time of wound cleaning and debridement. [2]

The following table is a summary guide to tetanus prophylaxis in wound management:

History of Tetanus Immunization (Doses)	Clean, Minor Wounds		All Other Wounds Such as, but not limited to, wounds contaminated with dirt, feces, soil, and saliva; puncture wounds; avulsions; and wounds resulting from missiles, crushing, burns and frostbite.
	Td Adult type tetanus and diphtheria toxoids. If the patient is less than 7 years old, DT or DTP is preferred to tetanus toxoid alone. For persons ≥7 years of age, Td is preferred to tetanus toxoid alone.	TIG Inmunogamma Antitet (Human).	Td	TIG
Uncertain or less than 3	Yes	No	Yes	Yes
3 or more If only three doses of fluid tetanus toxoid have been received, a fourth dose of toxoid, preferably an adsorbed toxoid, should be given.	No Yes if more than 10 years since the last dose.	No	No Yes if more than 5 years since the last dose. (More frequent boosters are not needed and can accentuate side effects).	No

CONTRAINDICATIONS

None known.

WARNINGS

HyperTET 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.

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

In patients who have severe thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injections, HyperTET S/D should be given only if the expected benefits outweigh the risks.

PRECAUTIONS

General

HyperTET S/D should not be given intravenously. Intravenous injection of immunoglobulin intended for intramuscular use can, on occasion, cause a precipitous fall in blood pressure, and a picture not unlike anaphylaxis. Injections should only be made intramuscularly and care should be taken to draw back on the plunger of the syringe before injection in order to be certain that the needle is not in a blood vessel. Intramuscular injections are preferably administered 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. [16]

Chemoprophylaxis against tetanus is neither practical nor useful in managing wounds. Wound cleaning, debridement when indicated, and proper immunization are important. The need for tetanus toxoid, with or without TIG (passive immunization), depends on both the condition of the wound and the patient’s vaccination history. Rarely has tetanus occurred among persons with documentation of having received a primary series of toxoid injections. [2] See table under INDICATIONS AND USAGE.

Skin tests should not be done. The intradermal injection of concentrated IgG solutions often causes a localized area of inflammation which can be misinterpreted as a positive allergic reaction. In actuality, this does not represent an allergy; rather, it is localized tissue irritation. Misinterpretation of the results of such tests can lead the physician to withhold needed human antitoxin from a patient who is not actually allergic to this material. True allergic responses to human IgG given in the prescribed intramuscular manner are rare.

Although systemic reactions to human immunoglobulin preparations are rare, epinephrine should be available for treatment of acute anaphylactic reactions.

Drug Interactions

Antibodies in immunoglobulin preparations may interfere with the response to live viral vaccines such as measles, mumps, polio, and rubella. Therefore, use of such vaccines should be deferred until approximately 3 months after Inmunogamma Antitet (Human) - HyperTET ^® S/D administration.

No interactions with other products are known.

Pregnancy Category C

Animal reproduction studies have not been conducted with HyperTET S/D. It is also not known whether HyperTET S/D can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. HyperTET 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

Slight soreness at the site of injection and slight temperature elevation may be noted at times. Sensitization to repeated injections of human immunoglobulin is extremely rare.

In the course of routine injections of large numbers of persons with immunoglobulin there have been a few isolated occurrences of angioneurotic edema, nephrotic syndrome, and anaphylactic shock after injection.

OVERDOSAGE

Although no data are available, clinical experience with other immunoglobulin preparations suggests that the only manifestations would be pain and tenderness at the injection site.

DOSAGE AND ADMINISTRATION

Routine prophylactic dosage schedule:

• 
  

  Adults and children 7 years and older: HyperTET S/D, 250 units should be given by deep intramuscular injection. At the same time, but in a different extremity and with a separate syringe, Tetanus and Diphtheria Toxoids Adsorbed (For Adult Use) (Td) should be administered according to the manufacturer's package insert. Adults with uncertain histories of a complete primary vaccination series should receive a primary series using the combined Td toxoid. To ensure continued protection, booster doses of Td should be given every 10 years. [2]
  

• 
  

  Children less than 7 years old: In small children the routine prophylactic dose of HyperTET S/D may be calculated by the body weight (4.0 units/kg). However, it may be advisable to administer the entire contents of the syringe of HyperTET S/D (250 units) regardless of the child's size, since theoretically the same amount of toxin will be produced in the child's body by the infecting tetanus organism as it will in an adult's body. At the same time but in a different extremity and with a different syringe, Diphtheria and Tetanus Toxoids and Pertussis Vaccine Adsorbed (DTP) or Diphtheria and Tetanus Toxoids Adsorbed (For Pediatric Use) (DT), if pertussis vaccine is contraindicated, should be administered per the manufacturer's package insert.
  

• 
  

  Note: The single injection of tetanus toxoid only initiates the series for producing active immunity in the recipient. The physician must impress upon the patient the need for further toxoid injections in 1 month and 1 year. Without such, the active immunization series is incomplete. If a contraindication to using tetanus toxoid-containing preparations exists for a person who has not completed a primary series of tetanus toxoid immunization and that person has a wound that is neither clean nor minor, only passive immunization should be given using Inmunogamma Antitet. [2] See table under INDICATIONS AND USAGE.
  

• 
  

  Available evidence indicates that complete primary vaccination with tetanus toxoid provides long lasting protection ≥10 years for most recipients. Consequently, after complete primary tetanus vaccination, boosters-even for wound management-need be given only every 10 years when wounds are minor and uncontaminated. For other wounds, a booster is appropriate if the patient has not received tetanus toxoid within the preceding 5 years. Persons who have received at least two doses of tetanus toxoid rapidly develop antibodies. [2] The prophylactic dosage schedule for these patients and for those with incomplete or uncertain immunity is shown on the table in INDICATIONS AND USAGE.
  

• 
  

  Since tetanus is actually a local infection, proper initial wound care is of paramount importance. The use of antitoxin is adjunctive to this procedure. However, in approximately 10% of recent tetanus cases, no wound or other breach in skin or mucous membrane could be implicated. [17]
  

Treatment of active cases of tetanus:

• Standard therapy for the treatment of active tetanus including the use of HyperTET S/D must be implemented immediately. The dosage should be adjusted according to the severity of the infection. [7,8]
  

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. They should not be used if particulate matter and/or discoloration are present.

HyperTET S/D is supplied with a syringe and an attached UltraSafe^® Needle Guard for your protection and convenience. Please follow instructions below for proper use of syringe and UltraSafe^® Needle Guard.

Directions for Syringe Usage

• Remove the prefilled syringe from the package. Lift syringe by barrel, not by plunger.
• Twist the plunger rod clockwise until the threads are seated.
• With the rubber needle shield secured on the syringe tip, push the plunger rod forward a few millimeters to break any friction seal between the rubber stopper and the glass syringe barrel.
• Remove the needle shield and expel air bubbles. [Do not remove the rubber needle shield to prepare the product for administration until immediately prior to the anticipated injection time.]
• Proceed with hypodermic needle puncture.
• Aspirate prior to injection to confirm that the needle is not in a vein or artery.
• Inject the medication.
• Keeping your hands behind the needle, grasp the guard with free hand and slide forward toward needle until it is completely covered and guard clicks into place. If audible click is not heard, guard may not be completely activated.
• Place entire prefilled glass syringe with guard activated into an approved sharps container for proper disposal.

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.

HOW SUPPLIED

HyperTET S/D is supplied in 250 unit prefilled disposable syringes with attached needles. HyperTET S/D is preservative-free, in a latex-free delivery system.

NDC Number	Size
13533-634-02	250 unit syringe

STORAGE

Store at 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.

REFERENCES

• Tetanus - United States, 1987 and 1988, MMWR 39(3): 37-41, 1990.
• Diphtheria, Tetanus, and Pertussis: Recommendations for Vaccine Use and Other Preventive Measures. Recommendations of the Immunization Practices Advisory Committee (ACIP). MMWR 40 (RR-10): 1-28, 1991.
• Moynihan NH: Tetanus prophylaxis and serum sensitivity tests. Br Med J 1:260-4, 1956.
• Scheibel I: The uses and results of active tetanus immunization. Bull WHO 13:381-94, 1955.
• Edsall G: Specific prophylaxis of tetanus. JAMA 171(4):417-27, 1959.
• Bardenwerper HW: Serum neuritis from tetanus antitoxin. JAMA 179(10):763-6, 1962.
• Nation NS, Pierce NF, Adler SJ, et al: Tetanus: the use of human hyperimmune globulin in treatment. Calif Med 98(6):305-6, 1963.
• Ellis M: Human antitetanus serum in the treatment of tetanus. Br Med J 1(5338):1123-6, 1963.
• Axnick NW, Alexander ER: Tetanus in the United States: A review of the problem. Am J Public Health 47(12):1493-1501, 1957.
• Blake PA, Feldman RA, Buchanan TM, et al: Serologic therapy of tetanus in the United States, 1965-1971. JAMA 235(1):42-4, 1976.
• Rubbo SD: New approaches to tetanus prophylaxis. Lancet 2(7461):449-53, 1966.
• McComb JA, Dwyer RC: Passive-active immunization with Inmunogamma Antitet (human). N Engl J Med 268(16):857-62, 1963.
• Levine L, McComb JA, Dwyer RC, et al: Active-passive tetanus immunization; choice of toxoid, dose of Inmunogamma Antitet and timing of injections. N Engl J Med 274(4):186-90, 1966.
• Waldmann TA, Strober W, Blaese RM: Variations in the metabolism of immunoglobulins measured by turnover rates. In Merler E (ed.): Immunoglobulins: biologic aspects and clinical uses. Washington, DC, Nat Acad Sci, 1970, p. 33-51.
• McCracken GH Jr., Dowell DL, Marshall FN: Double-blind trial of equine antitoxin and human immune globulin in tetanus neonatorum. Lancet 1(7710):1146-9, 1971.
• Recommendations of the Advisory Committee on Immunization Practices (ACIP) and the American Academy of Family Physicians (AAFP): General recommendations on immunization. MMWR 2002: 51(RR02), 1-36.
• Tetanus-Rates by year, United States, 1955-1984. Annual Summary 1984. MMWR 33 (54):61, 1986.
• Stenland CJ, Lee DC, Brown P, et al. Partitioning of human and sheep forms of the pathogenic prion protein during the purification of therapeutic proteins from human plasma. Transfusion 2002. 42(11):1497-500.
• Lee DC, Stenland CJ, Miller JL, et al. A direct relationship between the partitioning of the pathogenic prion protein and transmissible spongiform encephalopathy infectivity during the purification of plasma proteins. Transfusion 2001. 41(4):449-55.
• Lee DC, Stenland CJ, Hartwell RC, et al. Monitoring plasma processing steps with a sensitive Western blot assay for the detection of the prion protein. J Virol Methods 2000. 84(1):77-89.
• Cai K, Miller JL, Stenland CJ, et al. Solvent-dependent precipitation of prion protein. Biochim Biophys Acta 2002. 1597(1):28-35.

Grifols Therapeutics Inc.

Research Triangle Park, NC 27709 USA

U.S. License No. 1871

08941121

(Rev. September 2012)

Inmunogamma Antitet (Human)

HyperTET ^® S/D

Solvent/Detergent Treated

Preservative-free,

latex-free delivery system

250 Units

Contents: One single dose disposable syringe with attached needle.

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

The potency of each syringe is not less than 250 antitoxin units based on the U.S. Standard Antitoxin and the U.S. Control Tetanus Toxin.

FOR INTRAMUSCULAR INJECTION ONLY. DO NOT GIVE INTRAVENOUSLY.

Store at 2–8°C (36–46°F).

Do not freeze.

NDC 13533-634-02

GRIFOLS

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

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

For directions for syringe usage, see enclosed package insert.

Do not use if the syringe is prematurely engaged.

Not returnable for credit or exchange.

Rx only

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

Grifols Therapeutics Inc.

Research Triangle Park,

NC 27709 USA

U.S. License No. 1871

Carton: 08940722

Inmunogamma Antitet (Human)

HyperTET ^® S/D

Solvent/Detergent Treated

250 Units

Grifols Therapeutics Inc.

Research Triangle Park,

NC 27709 USA

U.S. License No. 1871

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

08940699

Lot

Exp.

Inmunogamma Antitet pharmaceutical active ingredients containing related brand and generic drugs:

• Tetanus Immune Globulin

Inmunogamma Antitet available forms, composition, doses:

• N/A

Inmunogamma Antitet destination | category:

• Human:
• Vaccines, antisera and immunologicals

Inmunogamma Antitet Anatomical Therapeutic Chemical codes:

• J06BB02 - Tetanus Immunoglobulin

Inmunogamma Antitet pharmaceutical companies:

• Leti Laboratorios

References

1. Dailymed."HYPERTET S/D (TETANUS 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 Inmunogamma Antitet?

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

Review

sdrugs.com conducted a study on Inmunogamma Antitet, 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 Inmunogamma Antitet 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