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HibTITER

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HibTITER

HibTITER® (diphtheria crm197 protein conjugate)
(Diphtheria CRM197Protein Conjugate) Haemophilus b Conjugate Vaccine




DRUG DESCRIPTION

Haemophilus b Conjugate Vaccine (Diphtheria CRM197 Protein Conjugate) HibTITER (diphtheria crm197 protein conjugate) is a sterile solution of a conjugate of oligosaccharides of the capsular antigen of Haemophilus influenzae type b (Haemophilus b) and diphtheria CRM197 protein (CRM197) dissolved in 0.9% sodium chloride. The oligosaccharides are derived from highly purified capsular polysaccharide, polyribosylribitol phosphate, isolated from Haemophilus b strain Eagan grown in a chemically defined medium (a mixture of mineral salts, amino acids, and cofactors). The oligosaccharides are purified and sized by diafiltrations through a series of ultrafiltration membranes, and coupled by reductive amination directly to highly purified CRM197.1,2 CRM197 is a nontoxic variant of diphtheria toxin isolated from cultures of Corynebacterium diphtheriae C7 (β197) grown in a casamino acids and yeast extract-based medium that is ultrafiltered before use. CRM197 is purified through ultrafiltration, ammonium sulfate precipitation, and ion-exchange chromatography to high purity. The conjugate is purified to remove unreacted protein, oligosaccharides, and reagents; sterilized by filtration; and filled into vials. HibTITER (diphtheria crm197 protein conjugate) is intended for intramuscular use.

The vaccine is a clear, colorless solution. Each single dose of 0.5 mL is formulated to contain 10 µg of purified Haemophilus b saccharide and approximately 25 µg of CRM197 protein. The potency of HibTITER (diphtheria crm197 protein conjugate) is determined by chemical assay for polyribosylribitol.

What are the precautions when taking diphtheria crm197 protein conjugate (HibTITER)?

Before receiving this vaccination, tell the health care professional if your child is allergic to it or to any other vaccines; or if your child has any other allergies. This product may contain inactive ingredients (such as latex), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before receiving this vaccine, tell your health care professional your child's medical history, especially of: high fever, moderate/severe acute illness, bleeding disorders, history of Guillain-Barre syndrome, a weakened immune system (e.g., due to cancer, HIV, leukemia, lymphoma, radiation treatment), vaccination history including previous reactions to any vaccines.

Patients with Hodgkin's disease should receive the vaccine at least 10-14 days before...

Read All Potential Precautions of HibTITER »

REFERENCES

What are the precautions when taking diphtheria crm197 protein conjugate (HibTITER)?

Before receiving this vaccination, tell the health care professional if your child is allergic to it or to any other vaccines; or if your child has any other allergies. This product may contain inactive ingredients (such as latex), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before receiving this vaccine, tell your health care professional your child's medical history, especially of: high fever, moderate/severe acute illness, bleeding disorders, history of Guillain-Barre syndrome, a weakened immune system (e.g., due to cancer, HIV, leukemia, lymphoma, radiation treatment), vaccination history including previous reactions to any vaccines.

Patients with Hodgkin's disease should receive the vaccine at least 10-14 days before...

Read All Potential Precautions of HibTITER »

1. United States Patent Number 4,902,506 by Anderson PW, Eby filed May 5, 1986 issued February 20, 1990.

What are the precautions when taking diphtheria crm197 protein conjugate (HibTITER)?

Before receiving this vaccination, tell the health care professional if your child is allergic to it or to any other vaccines; or if your child has any other allergies. This product may contain inactive ingredients (such as latex), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before receiving this vaccine, tell your health care professional your child's medical history, especially of: high fever, moderate/severe acute illness, bleeding disorders, history of Guillain-Barre syndrome, a weakened immune system (e.g., due to cancer, HIV, leukemia, lymphoma, radiation treatment), vaccination history including previous reactions to any vaccines.

Patients with Hodgkin's disease should receive the vaccine at least 10-14 days before...

Read All Potential Precautions of HibTITER »

2. Seid RC Jr, Boykins RA, Liu DF, et al. Chemical evidence for covalent linkage of a semi-synthetic glycoconjugate vaccine for Haemophilus influenzae type b disease. Glycoconjugate J. 1989;6:489-498.

What are the precautions when taking diphtheria crm197 protein conjugate (HibTITER)?

Before receiving this vaccination, tell the health care professional if your child is allergic to it or to any other vaccines; or if your child has any other allergies. This product may contain inactive ingredients (such as latex), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before receiving this vaccine, tell your health care professional your child's medical history, especially of: high fever, moderate/severe acute illness, bleeding disorders, history of Guillain-Barre syndrome, a weakened immune system (e.g., due to cancer, HIV, leukemia, lymphoma, radiation treatment), vaccination history including previous reactions to any vaccines.

Patients with Hodgkin's disease should receive the vaccine at least 10-14 days before...

Read All Potential Precautions of HibTITER »

Last reviewed on RxList: 3/9/2009
This monograph has been modified to include the generic and brand name in many instances.

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.


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