"The European Medicines Agency (EMA) has launched a review of the six direct-acting antivirals approved for use in the European Union for treating chronic hepatitis C virus infection, the agency said today.
They are daclatasvir (Dak"...
The prophylactic value of BayGam (immune globulin) is greatest when given before or soon after exposure to hepatitis A. BayGam (immune globulin) is not indicated in persons with clinical manifestations of hepatitis A or in those exposed more than 2 weeks previously.
BayGam (immune globulin) should be given to prevent or modify measles in a susceptible person exposed fewer than 6 days previously.7 A susceptible person is one who has not been vaccinated and has not had measles previously. BayGam (immune globulin) may be especially indicated for susceptible household contacts of measles patients, particularly contacts under 1 year of age, for whom the risk of complications is highest.7 BayGam (immune globulin) and measles vaccine should not be given at the same time.7 If a child is older than 12 months and has received BayGam (immune globulin) , he should be given measles vaccine about 3 months later when the measles antibody titer will have disappeared.
If a susceptible child exposed to measles is immunocompromised, BayGam (immune globulin) should be given immediately.8 Children who are immunocompromised should not receive measles vaccine or any other live viral vaccine.
Passive immunization against varicella in immunosuppressed patients is best accomplished by use of Varicella-Zoster Immune Globulin (Human) [VZIG]. If VZIG is unavailable, BayGam (immune globulin) , promptly given, may also modify varicella.5
The routine use of BayGam (immune globulin) for prophylaxis of rubella in early pregnancy is of dubious value and cannot be justified.6 Some studies suggest that the use of BayGam (immune globulin) in exposed, susceptible women can lessen the likelihood of infection and fetal damage; therefore, BayGam (immune globulin) may benefit those women who will notconsider a therapeutic abortion.4
In patients with immunoglobulin deficiencies, BayGam (immune globulin) may prevent serious infection. However, BayGam (immune globulin) may not prevent chronic infections of the external secretory tissues such as the respiratory and gastrointestinal tract.
Prophylactic therapy, especially against infections due to encapsulated bacteria, is effective in Bruton-type, sex-linked, congenital agammaglobulinemia, agammaglobulinemia associated with thymoma, and acquired agammaglobulinemia.
DOSAGE AND ADMINISTRATION
BayGam (immune globulin) is administered intramuscularly (see PRECAUTIONS), preferably in the anterolateral aspects of the upper thigh and the deltoid muscle of the upper arm. The gluteal region should not be used routinely as an injection site because of the risk of injury to the sciatic nerve. Doses over 10 mL should be divided and injected into several muscle sites to reduce local pain and discomfort. An individual decision as to which muscle is injected must be made for each patient based on the volume of material to be administered. If the gluteal region is used when very large volumes are to be injected or multiple doses are necessary, the central region MUST be avoided; only the upper, outer quadrant should be used.10
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
BayGam (immune globulin) in a dose of 0.01 mL/lb (0.02 mL/kg) is recommended for household and institutional hepatitis A case contacts. The following doses of BayGam (immune globulin) are recommended for persons who plan to travel in areas where hepatitis A is common.3
|Length of Stay||Dose Volume|
|Less than 3 months||0.02 mL/kg|
|3 months or longer||0.06 mL/kg (repeat every 4–6 months)|
BayGam (immune globulin) should be given in a dose of 0.11 mL/lb (0.25 mL/kg) to prevent or modify measles in a susceptible person exposed fewer than 6 days previously.7 A susceptible child who is exposed to measles and who is immunocompromised should receive a dose of 0.5 mL/kg (maximum dose, 15 mL) of BayGam (immune globulin) immediately.8
If Varicella-Zoster Immune Globulin (Human) is unavailable, BayGam (immune globulin) at a dose of 0.6 to 1.2 mL/kg, promptly given, may also modify varicella.5
Some studies suggest that the use of BayGam (immune globulin) in exposed, susceptible women can lessen the likelihood of infection and fetal damage; therefore, BayGam (immune globulin) at a dose of 0.55 mL/kg may benefit those women who will not consider a therapeutic abortion.4
BayGam (immune globulin) may prevent serious infection in patients with immunoglobulin deficiencies if circulating IgG levels of approximately 200 mg/100 mL plasma are maintained. The recommended dosage is 0.66 mL/kg (at least 100 mg/kg) given every 3 to 4 weeks.6 A double dose is given at onset of therapy; some patients may require more frequent injections.
BayGam (immune globulin) is supplied in 2 mL and 10 mL single dose vials.
|0026-0635-02||2 mL vial (10 pack)|
|0026-0635-04||2 mL vial|
|0026-0635-10||10 mL vial (10 pack)|
|0026-0635-12||10 mL vial|
Store at 2–8°C (36–46°F). Do not freeze. Do not use after expiration date.
U.S. federal law prohibits dispensing without prescription.
A number of factors beyond our control 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.
4. American Academy of Pediatrics, Committee on Infectious Diseases: Report. ed. 19. Evanston, 1982, p 231.
5. Gershon AA, Piomelli S, Karpatkin M, et al: Antibody to varicella-zoster virus after passive immunization against chicken-pox. J Clin Microbiol 8(6): 733-5, 1978.
6. American Academy of Pediatrics, Committee on Infectious Diseases: Report. ed. 19. Evanston, 1982, pp 134-5.
7. Recommendation of the Public Health Service Advisory Committee on Immunization Practices: Measles prevention. MMWR 27(44): 427-30; 435-7, 1978.
8. American Academy of Pediatrics, Committee on Infectious Diseases: Report. ed. 19. Evanston, 1982, pp 34-6.
10. Recommendations of the Immunization Practices Advisory Committee (ACIP): General recommendations on immunization. MMWR 38(13): 205-14: 219-27, 1989.
Bayer Corporation, Pharmaceutical Division Elkhart, IN 46515 USA. Rev. April 1998. FDA revision date: n/aThis monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 11/13/2008
Additional Baygam Information
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