Special Warning : אזהרת שימוש

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 the Ministry of Health according to the National Regulation by using an online form https://sideeffects.health.gov.il.

Additionally, you can also report to www.perrigo-pharma.co.il.

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.

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. Patients who have not completed a primary series may require tetanus toxoid and passive immunization at the time of wound cleaning and debridement.9

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

Guide to Tetanus Prophylaxis in Wound Management9

History of Tetanus          Clean, Minor Wounds        All Other Wounds* Immunization               Td†           TIG‡        Td            TIG (Doses)
Uncertain or less than 3          Yes             No        Yes           Yes 3 or more§                        No¶             No        NO#           No 
* 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.
† 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. (see Dosage and Administration).
‡ Tetanus Immune Globulin (Human).
§ If only three doses of fluid tetanus toxoid have been received, a fourth  dose of toxoid, preferably an adsorbed toxoid, should be given.
¶ Yes if more than 10 years since the last dose.
# Yes if more than 5 years since the last dose. (More frequent boosters are  not needed and can accentuate side effects).

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.20

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 (active immunization), 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.9 See table under WARNINGS.

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.

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