Recommended Topic Related To:

Acthib

"Oct. 22, 2012 -- One in three kids in America is overweight or obese, and having stressed-out parents may be contributing to these rates, a new study suggests.

The more stress the parents report, the more likely their children are to "...

ActHIB

ActHIB

WARNINGS

If ActHIB (haemophilus b conjugate vaccine) ® or ActHIB (haemophilus b conjugate vaccine) ® reconstituted with AvP DTP or ActHIB (haemophilus b conjugate vaccine) ® reconstituted with Tripedia® (TriHIBit® ) is administered to immunosuppressed persons or persons receiving immunosuppressive therapy, the expected antibody responses may not be obtained. This includes patients with asymptomatic or symptomatic HIV- infection, 21 severe combined immunodeficiency, hypogammaglobulinemia, or agammaglobulinemia; altered immune states due to diseases such as leukemia, lymphoma, or generalized malignancy; or an immune system compromised by treatment with corticosteroids, alkylating drugs, antimetabolites or radiation. 22 (Refer to product inserts for AvP whole-cell DTP and Tripedia®.)

TriHIBit® ActHIB (haemophilus b conjugate vaccine) ® combined with Tripedia® by reconstitution should not be administered to infants younger than 15 months of age.

PRECAUTIONS

General

Care is to be taken by the health-care provider for the safe and effective use of this vaccine.

EPINEPHRINE INJECTION (1:1000) MUST BE IMMEDIATELY AVAILABLE SHOULD AN ANAPHYLACTIC OR OTHER ALLERGIC REACTIONS OCCUR DUE TO ANY COMPONENT OF THE VACCINE.

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 sensitivity and any previous adverse reactions to the vaccine or similar vaccines, previous immunization history, current health status (see CONTRAINDICATIONS; WARNINGS sections) and a current knowledge of the literature concerning the use of the vaccine under consideration. (Refer to product inserts for AvP whole-cell DTP and Tripedia®)

The health-care provider should ask the parent or guardian about the recent health status of the infant or child to be immunized including the infant's or child's previous immunization history prior to administration of ActHIB (haemophilus b conjugate vaccine) ® AvP DTP and Tripedia® .

Minor illnesses such as upper respiratory infection with or without low grade fever are not contraindications for use of ActHIB (haemophilus b conjugate vaccine) ® .23

As reported with Haemophilus b polysaccharide vaccines, 24 cases of H influenzae type b disease may occur subsequent to vaccination and prior to the onset of protective effects of the vaccine. 18 (See INDICATIONS AND USAGE section.)

The evidence favors rejection of a causal relation between immunization with Hib conjugate vaccines and earlyonset Hib disease. 25

Antigenuria has been detected in some instances following receipt of ActHIB (haemophilus b conjugate vaccine) ®; therefore, urine antigen detection may not have definitive diagnostic value in suspected H influenzaetype b disease within one week of immunization. 26

Special care should be taken to ensure that ActHIB (haemophilus b conjugate vaccine) ® reconstituted with AvP DTP or Tripedia® or saline diluent (0.4% Sodium Chloride) is not injected into a blood vessel.

Administration of ActHIB (haemophilus b conjugate vaccine) ® reconstituted with AvP DTP or ActHIB (haemophilus b conjugate vaccine) ® reconstituted with Tripedia® (TriHIBit®) or saline diluent (0.4% Sodium Chloride) is not contraindicated in individuals with HIV infection. 22

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 properly disposed.

Caution: The stopper of the diluent vial contains dry natural latex rubber which may cause allergic reactions. The lyophilized vaccine vial contains no rubber of any kind.

CARCINOGENESIS, MUTAGENESIS, IMPAIRMENT OF FERTILITY

ActHIB (haemophilus b conjugate vaccine) ® reconstituted with AvP DTP or ActHIB (haemophilus b conjugate vaccine) ® reconstituted with Tripedia® (TriHIBit® has not been evaluated for its carcinogenic, mutagenic potential or impairment of fertility.)

PREGNANCY

REPRODUCTIVE STUDIES - PREGNANCY CATEGORY C
Animal reproduction studies have not been conducted with ActHIB (haemophilus b conjugate vaccine) ® reconstituted with AvP DTP or ActHIB (haemophilus b conjugate vaccine) ® reconstituted with Tripedia® (TriHIBit® or saline diluent (0.4% Sodium Chloride). It is also not known whether ActHIB (haemophilus b conjugate vaccine) ® reconstituted with AvP DTP or ActHIB (haemophilus b conjugate vaccine) ® reconstituted with Tripedia® (TriHIBit® or saline diluent (0.4% Sodium Chloride) can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. ActHIB (haemophilus b conjugate vaccine) ® reconstituted with AvP DTP or ActHIB (haemophilus b conjugate vaccine) ® reconstituted with Tripedia® (TriHIBit® or saline diluent (0.4% Sodium Chloride) is NOT recommended for use in a pregnant woman and is not approved for use in children 5 years of age or older.

PEDIATRIC

USE SAFETY AND EFFECTIVENESS OF TriHIBitTM, ActHIB (haemophilus b conjugate vaccine) ® RECONSTITUTED WITH Tripedia® , IN INFANTS BELOW THE AGE OF 15 MONTHS HAVE NOT BEEN ESTABLISHED. (See DOSAGE AND ADMINISTRATION section.)

SAFETY AND EFFECTIVENESS OF ActHIB (haemophilus b conjugate vaccine) ® RECONSTITUTED WITH AvP DTP OR SALINE DILUENT (0.4% SODIUM CHLORIDE) IN INFANTS BELOW THE AGE OF SIX WEEKS HAVE NOT BEEN ESTABLISHED. (See DOSAGE AND ADMINISTRATION section.)

Last reviewed on RxList: 12/8/2004
This monograph has been modified to include the generic and brand name in many instances.

A A A

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


Parenting and Pregnancy

Get tips for baby and you.

Related Drugs
advertisement
advertisement
Use Pill Finder Find it Now See Interactions

Pill Identifier on RxList

  • quick, easy,
    pill identification

Find a Local Pharmacy

  • including 24 hour, pharmacies

Interaction Checker

  • Check potential drug interactions
Search the Medical Dictionary for Health Definitions & Medical Abbreviations