Consists of Diphtheria Toxoid, Haemophilus B Conjugate Vaccine, Pertussis Toxoid, Tetanus Toxoid
Dosage of Haemophilus B Conjugate Vaccine in details
Haemophilus B Conjugate Vaccine (diphtheria crm197 protein conjugate) is for intramuscular use only.
Any parenteral drug product should be inspected visually for particulate matter and/or discoloration prior to administration whenever solution and container permit. If these conditions exist, or if cloudy, Haemophilus B Conjugate Vaccine (diphtheria crm197 protein conjugate) should not be administered.
Before injection, the skin over the site to be injected should be cleansed with a suitable germicide. After insertion of the needle, aspirate to help avoid inadvertent injection into a blood vessel.
The vaccine should be injected intramuscularly, preferably into the midlateral muscles of the thigh or deltoid, with care to avoid major peripheral nerve trunks. Do not inject in the gluteal area.
The vaccine is to be administered immediately after being drawn up into a syringe. Single dose 0.5 mL vial contains no preservative. Use one dose per vial; do not re-enter vial. Discard unused portions.
The vaccine is not to be mixed with other vaccines/products in the same syringe.
Haemophilus B Conjugate Vaccine (diphtheria crm197 protein conjugate) is indicated for children 2 months to 71 months of age for the prevention of invasive Haemophilus b disease. For infants 2 to 6 months of age, the immunizing dose is three separate injections of 0.5 mL given at approximately 2-month intervals. Previously unvaccinated infants from 7 through 11 months of age should receive two separate injections approximately 2 months apart. Children from 12 through 14 months of age who have not been vaccinated previously receive one injection. All vaccinated children receive a single booster dose at 15 months of age or older, but not less than 2 months after the previous dose. Previously unvaccinated children 15 to 71 months of age receive a single injection of Haemophilus B Conjugate Vaccine (diphtheria crm197 protein conjugate).
Each dose of 0.5 mL is formulated to contain 10 µg of purified Haemophilus b saccharide and approximately 25 µg of CRM protein.
Storage
DO NOT FREEZE. Store refrigerated away from freezer compartments at 2°C-8°C (36°F-46°F). Discard if the vaccine has been frozen.
How supplied
Vial, 1 Dose (5 per package) – Product No. 0005-0104-32
REFERENCES
32. Recommendations of the AAP: Haemophilus influenzae type b conjugate vaccines: recommendations for immunization of infants and children 2 months of age and older: update. Pediatrics. 1991;88:169-172.
33. Recommendation of the ACIP: Haemophilus b conjugate vaccines for prevention of Haemophilus influenzae type b disease among infants and children two months of age and older. MMWR. 1991;40:1-7.
34. Centers for Disease Control and Prevention. General recommendations on immunization: Recommendations of the Advisory Committee on Immunization Practices (ACIP) and the American Academy of Family Physicians (AAFP). MMWR. 2002;51(No. RR-2);1-36.
35. 2000 Red Book: Report of the Committee on Infectious Diseases. 25th ed. Elk Grove Village, IL: American Academy of Pediatrics; 2000: 26, 266-72.
55. Greenberg DP, Lieberman JM, Marcy SM, et al. Enhanced antibody responses in infants given different sequences of heterogenous Haemophilus influenzae type b conjugate vaccines. J Pediatr. 1995;126:206-11.
56. Anderson EL, Decker MD, Englund JA, et al. Interchangeability of conjugated Haemophilus influenzae type b vaccines in infants. JAMA. 1995;273:849-53.
57. Scheifele D, Law B, Mitchell L, Ochnio J. Study of booster doses of two Haemophilus influenzae type b conjugate vaccines including their interchangeability. Vaccine. 1996;14(15):1399-1406.
This product's label may have been revised after this insert was used in production. For further product information and current package insert, please visit www.wyeth.com or call our medical communications department toll free at 1-800-934-5556. Manufactured by: Wyeth Pharmaceuticals Inc. Philadelphia, PA 19101.
What other drugs will affect Haemophilus B Conjugate Vaccine?
Before your child receives this vaccine, tell the doctor about all other vaccines your child has recently received.
Other drugs may interact with haemophilus b conjugate vaccine, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell the doctor about all medications and treatments your child has recently received. Not all possible interactions are listed in this medication guide.
Haemophilus B Conjugate Vaccine interactions
Children receiving therapy with immunosuppressive agents (large amounts of corticosteroids,
antimetabolites, alkylating agents, cytotoxic agents) may not respond optimally to active
immunization.37,38,39
As with other intramuscular injections, Haemophilus B Conjugate Vaccine should be given with caution to children on
anticoagulant therapy.
No impairment of the antibody response to the individual antigens was demonstrated when
Haemophilus B Conjugate Vaccine was given at the same time but at separate sites as diphtheria tetanus pertussis vaccine
(DTP) plus oral polio vaccine (OPV) to children 2 to 20 months of age or measles-mumpsrubella
(MMR) to children 15 ± 1 month of age.20,43,44
Dosage of Tetanus Toxoid in details
Dosing: Adult
Note: Tetanus Toxoid (adsorbed) has been discontinued in the US for more than 1 year.
Note: In most patients, Td is the recommended product for primary immunization, booster doses, and tetanus immunization in wound management (refer to Diphtheria and Tetanus Toxoid monograph).
Primary immunization: IM: 0.5 mL; repeat 0.5 mL at 4-8 weeks after first dose and at 6-12 months after second dose
Routine booster dose: Recommended every 10 years
Tetanus prophylaxis in wound management: Tetanus prophylaxis in patients with wounds should consider if the wound is clean or contaminated, the immunization status of the patient, proper use of tetanus toxoid and/or tetanus immune globulin (TIG), wound cleaning, and (if required) surgical debridement and the proper use of antibiotics. Patients with an uncertain or incomplete tetanus immunization status should have additional follow up to ensure a series is completed. Patients with a history of Arthus reaction following a previous dose of a tetanus toxoid-containing vaccine should not receive a tetanus toxoid-containing vaccine until >10 years after the most recent dose even if they have a wound that is neither clean nor minor. See table.
History of Tetanus Immunization Doses | Clean, Minor Wounds | All Other Wounds | No | ||
|---|---|---|---|---|---|
History of Tetanus Immunization (Doses): Uncertain or <3 doses
Clean, Minor Wounds: Administer a tetanus toxoid containing vaccine. For children <7 years old DTaP (DT, if pertussis vaccine contraindicated) is preferred to tetanus toxoid alone. For children ≥7 years of age and Adults, Td preferred to tetanus toxoid alone; Tdap may be preferred if the patient has not previously been vaccinated with Tdap.
Other Wounds (such as, but not limited to, wounds contaminated with dirt, feces, soil, and saliva; puncture wounds; wounds from crushing, tears, burns, and frostbite): Administer a tetanus toxoid containing vaccine and TIG. For children <7 years old DTaP (DT, if pertussis vaccine contraindicated) is preferred to tetanus toxoid alone. For children ≥7 years of age and Adults, Td preferred to tetanus toxoid alone; Tdap may be preferred if the patient has not previously been vaccinated with Tdap.
History of Tetanus Immunization (Doses): 3 or more doses
Clean, Minor Wounds: Administer a tetanus toxoid containing vaccine if ≥10 years since last dose. For children <7 years old DTaP (DT, if pertussis vaccine contraindicated) is preferred to tetanus toxoid alone. For children ≥7 years of age and Adults, Td preferred to tetanus toxoid alone; Tdap may be preferred if the patient has not previously been vaccinated with Tdap.
Other Wounds (such as, but not limited to, wounds contaminated with dirt, feces, soil, and saliva; puncture wounds; wounds from crushing, tears, burns, and frostbite): Administer a tetanus toxoid containing vaccine if ≥5 years since last dose. For children <7 years old DTaP (DT, if pertussis vaccine contraindicated) is preferred to tetanus toxoid alone. For children ≥7 years of age and Adults, Td preferred to tetanus toxoid alone; Tdap may be preferred if the patient has not previously been vaccinated with Tdap.
Abbreviations: DT = Diphtheria and Tetanus Toxoids (formulation for age ≤6 years); DTaP = Diphtheria and Tetanus Toxoids, and Acellular Pertussis (formulation for age ≤6 years; Daptacel®, Infanrix®, Tripedia®); Td = Diphtheria and Tetanus Toxoids (formulation for age ≥7 years; Decavac®, Tenivac™); TT= Tetanus toxoid (adsorbed [formulation for age ≥7 years]); Tdap = Diphtheria and Tetanus Toxoids, and Acellular Pertussis (Adacel® or Boostrix® [formulations for age ≥7 years]); TIG = Tetanus Immune Globulin
Adapted from the Yellow Book 2010, Chapter 2, Routine Vaccine-Preventable Diseases, Tetanus; Available at www.cdc.gov/yellowbook and MMWR, 2006, 55:RR-17.
What other drugs will affect Tetanus Toxoid?
Before receiving this vaccine, tell your doctor about all other vaccines you have recently received.
Also tell the doctor if you have recently received drugs or treatments that can weaken the immune system, including:
-
an oral, nasal, inhaled, or injectable steroid;
-
chemotherapy or radiation cancer treatments;
-
medications to treat psoriasis, rheumatoid arthritis, or other autoimmune disorders, such as azathioprine (Imuran), etanercept (Enbrel), leflunomide (Arava), and others; or
-
medicines to treat or prevent organ transplant rejection, such as basiliximab (Simulect), cyclosporine (Sandimmune, Neoral, Gengraf), muromonab CD3 (Orthoclone), mycophenolate mofetil (CellCept), sirolimus (Rapamune), or tacrolimus (Prograf).
If you are using any of these medications, you may not be able to receive the vaccine, or may need to wait until the other treatments are finished.
This list is not complete and other drugs may interact with tetanus toxoid vaccine. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.
Tetanus Toxoid interactions
If passive immunization for tetanus is needed, TIG (Human) is the product of choice. It provides longer protection than antitoxin of animal origin and causes few adverse reactions. The currently recommended prophylactic dose of TIG (Human) for wounds of average severity is 250 units intramuscularly. When Tetanus Toxoid vaccine and TIG (Human) are given concurrently, separate syringes and separate sites should be used. The ACIP recommends the use of only adsorbed toxoid in this situation.
As with other intramuscular injections, use with caution in patients on anticoagulant therapy.
Immunosuppressive therapies may reduce the immune response to vaccines.
REFERENCES
1. Recommendations of the Immunization Practices Advisory Committee (ACIP). Diphtheria, Tetanus, and Pertussis: Recommendations for vaccine use and other preventive measures. MMWR 40: No. RR-10, 1991
6. Stratton KR, et al. Adverse events associated with childhood vaccines. Evidence Bearing on Causality. National Academy Press, Washington, DC, 1994
8. CDC. Vaccine Adverse Event Reporting System – United States. MMWR 39: 730-733, 1990
9. CDC. National Childhood Vaccine Injury Act: requirements for permanent vaccination records and for reporting of selected events after vaccination. MMWR 37: 197-200, 1988
10. Food and Drug Administration. New reporting requirements for vaccine adverse events. FDA Drug Bull 18 (2), 16-18, 1988
13. Rutledge SL, et al. Neurological complications of immunizations. J. Pediatr 109: 917-924, 1986
14. Wilson GS. The Hazards of Immunization. Allergic manifestations: post-vaccinal neuritis. pp 153-156, 1967
15. Tsairis P, et al. Natural history of brachial plexus neuropathy. Arch Neurol 27: 109-117, 1972
16. Blumstein GI, et al. Peripheral neuropathy following tetanus toxoid administration. JAMA 198: 1030-1031, 1966
17. Pollard JD, et al. Relapsing neuropathy due to tetanus toxoid: report of a case. J Neurol Sci 37: 112-125, 1978
Reviews
The results of a survey conducted on ndrugs.com for Diphtheria Toxoid/Haemophilus B Conjugate Vaccine/Pertussis Toxoid/Tetanus Toxoid are given in detail below. The results of the survey conducted are based on the impressions and views of the website users and consumers taking Diphtheria Toxoid/Haemophilus B Conjugate Vaccine/Pertussis Toxoid/Tetanus Toxoid. We implore you to kindly base your medical condition or therapeutic choices on the result or test conducted by a physician or licensed medical practitioners.User reports
Consumer reported frequency of use
No survey data has been collected yetConsumer reported doses
No survey data has been collected yetConsumer reviews
There are no reviews yet. Be the first to write one! |
Information checked by Dr. Sachin Kumar, MD Pharmacology
