Consists of Diphtheria Toxoid, Haemophilus B Conjugate Vaccine, Pertussis Toxoid, Tetanus Toxoid
What happens if I overdose Haemophilus B Conjugate Vaccine?
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local, or emergency room immediately.
Proper storage of Haemophilus B Conjugate Vaccine:
Haemophilus B Conjugate Vaccine is usually handled and stored by a health care provider. If you are using Haemophilus B Conjugate Vaccine at home, store Haemophilus B Conjugate Vaccine as directed by your pharmacist or health care provider. Keep Haemophilus B Conjugate Vaccine out of the reach of children and away from pets.
Overdose of Haemophilus B Conjugate Vaccine in details
There have been reports of overdose with Haemophilus B Conjugate Vaccine (diphtheria crm197 protein conjugate). Many cases were due to inadvertent coadministration with another Haemophilus b conjugate-containing vaccine. Most individuals were asymptomatic. In general, adverse events reported with overdosage have also been reported with recommended single doses of Haemophilus B Conjugate Vaccine (diphtheria crm197 protein conjugate).
What should I avoid while taking Haemophilus B Conjugate Vaccine?
Follow your doctor's instructions about any restrictions on food, beverages, or activity.
Haemophilus B Conjugate Vaccine warnings
Haemophilus B Conjugate Vaccine (diphtheria crm197 protein conjugate) WILL NOT PROTECT AGAINST H. INFLUENZAE OTHER THAN TYPE b STRAINS, NOR WILL Haemophilus B Conjugate Vaccine (diphtheria crm197 protein conjugate) PROTECT AGAINST OTHER MICROORGANISMS THAT CAUSE MENINGITIS OR SEPTIC DISEASE.
AS WITH ANY INTRAMUSCULAR INJECTION, Haemophilus B Conjugate Vaccine (diphtheria crm197 protein conjugate) SHOULD BE GIVEN WITH CAUTION TO INFANTS OR CHILDREN WITH THROMBOCYTOPENIA OR ANY COAGULATION DISORDER, OR TO THOSE RECEIVING ANTICOAGULANT THERAPY.
ANTIGENURIA HAS BEEN DETECTED FOLLOWING RECEIPT OF HAEMOPHILUS b CONJUGATE VACCINE AND THEREFORE ANTIGEN DETECTION IN URINE MAY NOT HAVE DIAGNOSTIC VALUE IN SUSPECTED HAEMOPHILUS b DISEASE WITHIN 2 WEEKS OF IMMUNIZATION.
The vial stopper contains dry natural rubber that may cause hypersensitivity reactions when handled by or when the product is injected into persons with known or possible latex sensitivity.
What should I discuss with my healthcare provider before taking Haemophilus B Conjugate Vaccine?
Some medical conditions may interact with Haemophilus B Conjugate Vaccine. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
- if you are pregnant, planning to become pregnant, or are breast-feeding
- if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
- if you have allergies to medicines, foods, or other substances
- if you have a history of blood clotting problems (eg, thrombocytopenia)
- if you have a fever, an infection, a weakened immune system, or HIV, or you are taking medicines that suppress the immune system (eg, corticosteroids)
Some MEDICINES MAY INTERACT with Haemophilus B Conjugate Vaccine. Tell your health care provider if you are taking any other medicines, especially any of the following:
- Immunosuppressive agents (eg, corticosteroids such as hydrocortisone) because the effectiveness of Haemophilus B Conjugate Vaccine may be decreased
- Anticoagulants (eg, warfarin) because the risk of bleeding may be increased
This may not be a complete list of all interactions that may occur. Ask your health care provider if Haemophilus B Conjugate Vaccine may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
Haemophilus B Conjugate Vaccine precautions
General
- CARE IS TO BE TAKEN BY THE HEALTH CARE PROVIDER FOR SAFE AND EFFECTIVE USE OF THIS PRODUCT.
- PRIOR TO ADMINISTRATION OF ANY DOSE OF Haemophilus B Conjugate Vaccine (diphtheria crm197 protein conjugate), THE PARENT OR GUARDIAN SHOULD BE ASKED ABOUT THE PERSONAL HISTORY, FAMILY HISTORY, AND RECENT HEALTH STATUS OF THE VACCINE RECIPIENT. THE HEALTH CARE PROVIDER SHOULD ASCERTAIN PREVIOUS IMMUNIZATION HISTORY, CURRENT HEALTH STATUS, AND OCCURRENCE OF ANY SYMPTOMS AND/OR SIGNS OF AN ADVERSE EVENT AFTER PREVIOUS IMMUNIZATION IN THE CHILD TO BE IMMUNIZED, IN ORDER TO DETERMINE THE EXISTENCE OF ANY CONTRAINDICATION TO IMMUNIZATION WITH Haemophilus B Conjugate Vaccine (diphtheria crm197 protein conjugate) AND TO ALLOW AN ASSESSMENT OF BENEFITS AND RISKS.
- BEFORE THE INJECTION OF ANY BIOLOGICAL, THE HEALTH CARE PROVIDER SHOULD TAKE ALL PRECAUTIONS KNOWN FOR THE PREVENTION OF ALLERGIC OR ANY OTHER SIDE REACTIONS. This should include: a review of the patient's history regarding possible sensitivity; the ready availability of epinephrine 1:1,000 and other appropriate agents used for control of immediate allergic reactions; and a knowledge of the recent literature pertaining to use of the biological concerned, including the nature of side effects and adverse reactions that may follow its use.
- Children with impaired immune responsiveness, whether due to the use of immunosuppressive therapy (including irradiation, corticosteroids, antimetabolites, alkylating agents, and cytotoxic agents), a genetic defect, human immunodeficiency virus (HIV) infection, or other causes, may have reduced antibody response to active immunization procedures.
- The vaccine should not be injected intradermally, subcutaneously, or intravenously since the safety and immunogenicity of these routes have not been evaluated. The vaccine should be given intramuscularly.
- A separate sterile syringe and needle or a sterile disposable unit should be used for each individual patient to prevent transmission of infectious agents from one person to another. Needles should be disposed of properly and should not be recapped.
- Special care should be taken to prevent injection into a blood vessel.
- 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.
- As with any vaccine, Haemophilus B Conjugate Vaccine® (diphtheria crm197 protein conjugate) may not protect 100% of individuals receiving the vaccine.
ALTHOUGH SOME ANTIBODY RESPONSE TO DIPHTHERIA TOXIN OCCURS, IMMUNIZATION WITH Haemophilus B Conjugate Vaccine (diphtheria crm197 protein conjugate) DOES NOT SUBSTITUTE FOR ROUTINE DIPHTHERIA IMMUNIZATION.
The vial stopper contains dry natural rubber that may cause hypersensitivity reactions when handled by or when the product is injected into persons with known or possible latex sensitivity.
Carcinogenesis, Mutagenesis, Impairment of Fertility
Haemophilus B Conjugate Vaccine (diphtheria crm197 protein conjugate) 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 Haemophilus B Conjugate Vaccine (diphtheria crm197 protein conjugate). It is also not known whether Haemophilus B Conjugate Vaccine (diphtheria crm197 protein conjugate) can cause fetal harm when administered to a pregnant woman or can affect reproduction capability. Haemophilus B Conjugate Vaccine (diphtheria crm197 protein conjugate) is NOT recommended for use in a pregnant woman.
Geriatric Use
This vaccine is NOT recommended for use in adult populations.
Pediatric Use
The safety and effectiveness of Haemophilus B Conjugate Vaccine (diphtheria crm197 protein conjugate) in children below the age of 6 weeks have not been established.
REFERENCES
3. Wenger JD, Ward JL, Broome CV. Prevention of Haemophilus influenzae type b disease: vaccines and passive prophylaxis. In: Remington JS, Swartz MS, eds. Current Clinical Topics in Infectious Diseases. New York, NY: McGraw-Hill Inc; 1989;10: 306-339.
20. Unpublished data available from Lederle Laboratories.
30. Black SB, Shinefield HR, Lampert D, et al. Safety and immunogenicity of oligosaccharide conjugate Haemophilus influenzae type b (HbOC) vaccine in infancy. Pediatr Infect Dis J. 1991;10:92-96
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.
36. Jones RG, Bass JW, Weisse ME, et al. Antigenuria after immunization with Haemophilus influenzae oligosaccharide CRM in United States infants. Pediatrics. 1998;101(4):604-11.
51. Wyeth Pharmaceuticals, Data on File: Prevnar Study D118-P8.
52. Black S, Shinefield H, Fireman B, et al. Efficacy, safety and immunogenicity of heptavalent pneumococcal conjugate vaccine in children. Pediatr Infect Dis J. 2000;19:187-95.
53. Milstein JB, Gross TP, Kuritsky JN. Adverse reactions reported following receipt of Haemophilus influenzae type b vaccine: an analysis after one year of marketing. Pediatrics. 1987;80:270-274.
54. D'Cruz DF, Shapiro ED, Spiegelman KN, et al. Acute inflammatory demyelinating polyradiculoneuropathy (Guillain-Barré syndrome) after immunization with Haemophilus influenzae type b conjugate vaccine. J Pediatr. 1989;115:743-746.
What happens if I miss a dose of Haemophilus B Conjugate Vaccine?
Contact your doctor if you will miss a booster dose or if you get behind schedule. The next dose should be given as soon as possible. There is no need to start over.
Be sure your child receives all recommended doses of this vaccine. If your child does not receive the full series of vaccines, he or she may not be fully protected against the disease.
What happens if I overdose Tetanus Toxoid?
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.
Proper storage of Tetanus Toxoid:
Tetanus Toxoid is usually handled and stored by a health care provider. If you are using Tetanus Toxoid at home, store Tetanus Toxoid as directed by your pharmacist or health care provider.
Overdose of Tetanus Toxoid in details
No information provided.
What should I avoid while taking Tetanus Toxoid?
Follow your doctor's instructions about any restrictions on food, beverages, or activity.
Tetanus Toxoid warnings
This product contains dry natural latex rubber as follows: The stopper to the vial contains dry natural latex rubber.
Persons who experienced Arthus-type hypersensitivity reactions or a temperature of > 103°F ( > 39.4°C) following a prior dose of tetanus toxoid usually have high serum tetanus antitoxin levels and should not be given even emergency doses of Tetanus Toxoid more frequently than every 10 years, even if they have a wound that is neither clean nor minor..
What should I discuss with my healthcare provider before taking Tetanus Toxoid?
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For tetanus toxoid, the following should be considered:
In deciding to receive this vaccine, the risks of receiving the vaccine must be weighed against the good it will do. This is a decision you and your doctor will make. For tetanus toxoid, the following should be considered:
Allergies
Tell your doctor if you have ever had any unusual or allergic reaction to tetanus toxoid or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Pediatric
Use is not recommended for infants up to 6 weeks of age. For infants and children 6 weeks of age and older, tetanus toxoid is not expected to cause different side effects or problems than it does in adults.
Geriatric
This vaccine is not expected to cause different side effects or problems in older people than it does in younger adults. However, the vaccine may be slightly less effective in older persons than in younger adults.
Pregnancy
| Pregnancy Category | Explanation | |
|---|---|---|
| All Trimesters | C | Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women. |
Breast Feeding
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Interactions with Medicines
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking tetanus toxoid, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using tetanus toxoid with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Cyclosporine
Using tetanus toxoid with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Chloramphenicol
- Meningococcal Vaccine, Tetanus Toxoid Conjugate Quadrivalent
Interactions with Food/Tobacco/Alcohol
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
Other Medical Problems
The presence of other medical problems may affect the use of tetanus toxoid. Make sure you tell your doctor if you have any other medical problems, especially:
- A severe reaction or a fever greater than 103 °F (39.4 °C) following a previous dose of tetanus toxoid—May increase the chance of side effects with future doses of tetanus toxoid; be sure your doctor knows about this before you receive the next dose of tetanus toxoid
- Bronchitis, pneumonia, or other illness involving lungs or bronchial tubes, or
- Severe illness with fever—Possible side effects from tetanus toxoid may be confused with the symptoms of the condition
Tetanus Toxoid precautions
General
Care is to be taken by the health-care provider for the safe and effective use of Tetanus Toxoid vaccine.
EPINEPHRINE INJECTION (1:1000) MUST BE IMMEDIATELY AVAILABLE SHOULD AN ACUTE ANAPHYLACTIC REACTION OCCUR DUE TO ANY COMPONENT OF THE VACCINE.
There is an increased incidence of local and systemic reactions to booster doses of tetanus toxoid when given to previously immunized persons. (Refer to DOSAGE AND ADMINISTRATION section for timing of booster injections.) Prior to an injection of any vaccine, all known precautions should be taken to prevent adverse reactions. This should include a review of the patient's history with respect to possible sensitivity and any previous adverse reactions to the vaccine or similar vaccines and to possible sensitivity to dry natural latex rubber, and a current knowledge of the literature concerning the use of the vaccine under consideration.
Special care should be taken to ensure that the injection does not enter a blood vessel.
Immunosuppressive therapies including radiation, corticosteroids, antimetabolites, alkylating agents, and cytotoxic drugs may reduce the immune response to vaccines. Therefore, routine vaccination should be deferred, if possible, while patients are receiving such therapy.
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
7. ACIP. General recommendations on immunization. MMWR 38: 205-227, 1989
11. MacLennan R, et al. Immunization against neonatal tetanus in New Guinea. Antitoxin response of pregnant women to adjuvant and plain toxoids. Bull WHO 32: 683-697, 1965
12. Newell KW, et al. The use of toxoid for the prevention of tetanus neonatorium. Bull WHO 35: 863-871, 1966
What happens if I miss a dose of Tetanus Toxoid?
If you miss a 10-year booster dose or if you get behind schedule, the next dose should be given as soon as possible.
Be sure to receive all recommended doses of this vaccine. You may not be fully protected if you do not receive the full series.
References
- DrugBank. "Clostridium tetani toxoid antigen (formaldehyde inactivated) - DrugBank". http://www.drugbank.ca/drugs/DB10583 (accessed September 17, 2018).
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Information checked by Dr. Sachin Kumar, MD Pharmacology
