"The U.S. Food and Drug Administration today notified Ranbaxy Laboratories, Ltd., that it is prohibited from manufacturing and distributing active pharmaceutical ingredients (APIs) from its facility in Toansa, India, for FDA-regulated drug product"...
If ProHIBiT (haemophilus b conjugate vaccine) ® is used in persons with malignancies or those receiving immunosuppressive therapy or who are otherwise immunocompromised, the expected immune response may not be obtained.
As with any vaccine, vaccination with ProHIBiT (haemophilus b conjugate vaccine) ® may not protect 100% of susceptible individuals.
As with the injection of any biological material, Epinephrine Injection (1:1000) should be available for immediate use should an anaphylactic or other allergic reaction occur.
Prior to an injection of any vaccine, all known precautions should be taken to prevent adverse reactions. This includes a review of the patient's history with respect to possible hypersensitivity to the vaccine or similar vaccines.
Any febrile illness or infection likely to be accompanied by fever is reason to delay the use of ProHIBiT (haemophilus b conjugate vaccine) ®, since fever may result occasionally from administration of ProHIBiT (haemophilus b conjugate vaccine) ® alone.
As reported with Haemophilus b polysaccharide vaccine,30 cases of Haemophilus b disease may occur in the week after vaccination, prior to the onset of protective effects of the vaccine.15
Antigenuria has been detected following receipt of Haemophilus b Conjugate Vaccine.31 Antigen detection may not have diagnostic value in suspected Haemophilus b disease within two weeks of immunization.
Special care should be taken to ensure that the injection does not enter a blood vessel.
A separate, sterile syringe and needle or a sterile disposable unit should be used for each patient to prevent transmission of hepatitis or other infectious agents from person to person. Needles should not be recapped and should be disposed of properly.
ALTHOUGH SOME IMMUNE RESPONSE TO THE DIPHTHERIA TOXOID COMPONENT MAY OCCUR, IMMUNIZATION WITH ProHIBiT (haemophilus b conjugate vaccine) ® DOES NOT SUBSTITUTE FOR ROUTINE DIPHTHERIA IMMUNIZATION.
Carcinogenesis, Mutagenesis, Impairment OF Fertility
ProHIBiT (haemophilus b conjugate vaccine) ® has not been evaluated for its carcinogenic, mutagenic potential or impairment of fertility.
Reproductive Studies – Pregnancy Category
Animal reproduction studies have not been conducted with ProHIBiT (haemophilus b conjugate vaccine) ®. It is also not known whether ProHIBiT (haemophilus b conjugate vaccine) ® can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. ProHIBiT (haemophilus b conjugate vaccine) ® is NOT recommended for use in a pregnant woman.
ProHIBiT (haemophilus b conjugate vaccine) ® IS NOT RECOMMENDED FOR USE IN CHILDREN YOUNGER THAN 12 MONTHS OF AGE.
15. Unpublished data available from Connaught Laboratories, Inc.
30. FDA Workshop on Haemophilus b Polysaccharide Vaccine - A Preliminary Report, MMWR 36: 529-531,1987
31. Scheifele D, et al. Antigenuria after receipt of Haemophilus b Diphtheria Toxoid Conjugate Vaccine. Pediatr Infect Dis J 8:887-888,1989
Last reviewed on RxList: 3/9/2009
This monograph has been modified to include the generic and brand name in many instances.
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