HYPERTET Solution for injection (2020)
Βιβλιογραφική αναφορά
Συγγραφείς
GRIFOLS USA, LLC
Λέξεις κλειδιά
13533-634
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1. Description
Tetanus Immune Globulin (Human) — HyperTET is a clear or slightly opalescent, and colorless or pale yellow or light brown sterile solution of human tetanus immune globulin for intramuscular administration. ...
2. Clinical Pharmacology
The occurrence of tetanus in the United States has decreased dramatically from 560 reported cases in 1947, when national reporting began, to a record low of 48 reported cases in 1987.(2) The decline has ...
3. Indications and Usage
HyperTET is indicated for prophylaxis against tetanus following injury in patients whose immunization is incomplete or uncertain (see below). It is also indicated, although evidence of effectiveness is ...
4. Contraindications
None known.
5. Warnings
<b>HyperTET 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. ...
6.1. General
<b>HyperTET should not be given intravenously.</b> Intravenous injection of immunoglobulin intended for intramuscular use can, on occasion, cause a precipitous fall in blood pressure, and a picture not ...
6.4. 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 ...
6.7. Pregnancy
Animal reproduction studies have not been conducted with HyperTET. It is also not known whether HyperTET can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. ...
6.10. Pediatric Use
Safety and effectiveness in the pediatric population have not been established.
7. 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 ...
9. 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.
10. Dosage and Administration
Routine prophylactic dosage schedule <u>Adults and children 7 years and older:</u> HyperTET, 250 units should be given by deep intramuscular injection (see PRECAUTIONS). At the same time, but in a different ...
11. How Supplied
HyperTET is supplied in 250 unit prefilled disposable syringes with attached needles. HyperTET contains no preservative and is not made with natural rubber latex. NDC Number Size 13533-634-02 250 unit ...
12. Storage and handling
Store at 2–8°C (36–46°F). Solution that has been frozen should not be used. Discard unused portion.
14. References
Barnette D, Roth NJ, Hotta J, et al. Pathogen safety profile of a 10% IgG preparation manufactured using a depth filtration-modified process. <em>Biologicals</em> 2012;40:247-53. Tetanus — United States, ...