Overdose of Quinvaxem in details
Not applicable.
Quinvaxem warnings
should under no circumstances be administered intravascularly or
intradermally. In children with progressive neurological disorders, including infantile spasms,
uncontrolled epilepsy or progressive encephalopathy, it is better to defer Pertussis (Quinvaxem) (Pa or
Pw) immunisation until the condition is corrected or stable. If any of the following events are known to have occurred in temporal relation to receipt of
whole cell or acellular Pertussis (Quinvaxem)-containing vaccine, the decision to give further doses of
vaccine containing the Pertussis (Quinvaxem) component should be carefully considered. There may be circumstances,
such as a high incidence of Pertussis (Quinvaxem), when the potential benefits outweigh possible risks,
particularly since these events are not associated with permanent sequelae.
? Temperature of ?40.0?C within 48 hours, not due to another identifiable cause.
? Collapse or shock-like state (hypotonic-hyporesponsive episode) within 48 hours of
vaccination.
? Persistent, inconsolable crying lasting ? 3 hours, occurring within 48 hours of
vaccination.
? Convulsions with or without fever, occurring within 3 days of vaccination.
A history of febrile convulsions, a family history of convulsions, or Sudden Infant Death
Syndrome (SIDS) do not constitute contra-indications for the use of vaccine.
Vaccinees with a history of febrile convulsions should be closely followed up as such
adverse events may occur within 2 to 3 days post vaccination.
As with other vaccines, the administration should be postponed in
subjects suffering from acute severe febrile illness. The presence of a minor infection,
however, is not a contraindication.
Quinvaxem precautions
General: Before administration of Quinvaxem, healthcare providers should inform the parent or guardian of the recipient to be immunized of the benefits and risks of immunization, inquire about the recent health status of the recipient, review the recipient’s history concerning possible hypersensitivity to the vaccine or similar vaccine, previous immunization history, the presence of any contraindications to immunization and comply with any local requirements with respect to information to be provided to the parent or guardian before immunization and the importance of completing the immunization series.
It is extremely important that the parent or guardian be questioned concerning any symptoms and/or signs of an adverse reaction after a previous dose of vaccine.
The rates and severity of adverse events in recipients of Tetanus (Quinvaxem) toxoid are influenced by the number of prior doses and level of pre-existing antitoxins.
As with any vaccine, Quinvaxem may not protect 100% of vaccinated individuals.
Vaccines that contain Hib antigen do not provide protection against infections with other types of H. influenzae or against meningitis of other origin.
Under no circumstances can the Tetanus (Quinvaxem) protein contained in conjugate vaccines containing Tetanus (Quinvaxem) toxoid as protein carrier be used to replace the usual Tetanus (Quinvaxem) vaccination.
Sudden infant death symdrome (SIDS) has occurred in infants following administration of DTaP vaccines. By chance alone, some cases of SIDS can be expected to follow recipient of Quinvaxem.
Administration Route Related Precautions: Do no administer Pedicel by intravascular injection; ensure that the needle dose not penetrate a blood vessel.
Intradermal or SC routes of administration are not to be utilized.
Quinvaxem should not be administered into the buttocks.
Granuloma or sterile abscess at the injection site has been reported with a product containing the same antigens.
Febrile or Acute Disease: Vaccination should be postponed in cases of acute or febrile disease. However, a disease with; low grade fever should not usually be a person to postpone vaccination.
If any of the following events occur within the specified period after administration of a whole cell Pertussis (Quinvaxem) vaccine or a vaccine containing an acellular Pertussis (Quinvaxem) component, the decision to administer Quinvaxem should be based on careful consideration of potential benefits and possible risks.
Temperature of ≥40.5°C (105°F) within 48 hrs, not attributable to another identifiable cause; collapse or shock-like state (hypotonic-hyporesponsive episode) within 48 hrs; persistent crying lasting ≥3 hrs within 48 hrs; convulsions with or without fever within 3 days.
Hematologic: Because any IM injection can cause an injection site hematoma in persons with any bleeding disorders eg, hemophilia or thrombocytopenia, or in persons on anticoagulant therapy, IM injections with Quinvaxem should not be administered to such persons unless the potential benefits outweigh the risk of administration. If the decision is made to administer any product by IM injection to such persons, it should be given with caution with steps taken to avoid the risk of hematoma formation following injection.
Immune: The possibility of allergic reactions in persons sensitive to components of the vaccine should be evaluated. Hypersensitivity reactions may occur following the use of Quinvaxem even in persons with no prior history of hypersensitivity to the product components. Cases of allergic or anaphylactic reaction have been reported after receiving some preparations containing Diphtheria (Quinvaxem) and Tetanus (Quinvaxem) toxoids and/or Pertussis (Quinvaxem) antigens.
As with all other products, epinephrine hydrochloride solution (1:1000) and other appropriate agents should be available for immediate use in case an anaphylactic or acute hypersensitivity reaction occurs. Healthcare providers should be familiar with current recommendations for the initial management of anaphylaxis in non-hospital settings, including proper airway management.
Immunocompromised persons (whether from disease or treatment) may not obtain the expected immune response. If possible, consideration should be given to delaying vaccination until after the completion of any immunosuppressive treatment. Nevertheless, vaccination of persons with chronic immunodeficiency eg, HIV infection is recommended even if the antibody response might be limited.
Neurologic: A review by the US Institute of Medicine (IOM) found evidence for a causal relation between Tetanus (Quinvaxem) toxoid and both brachial neuritis and Guillain-Barre syndrome (GBS). If GBS occurred within 6 weeks of receipt of prior vaccine containing Tetanus (Quinvaxem) toxoid, the decision to give Quinvaxem or any vaccine containing Tetanus (Quinvaxem) toxoid should be based on careful consideration of potential benefits and possible risks.
A few cases of demyelinating diseases of the central nervous system, peripheral mononeuropathies, and cranial mononeuropathies have been reported following vaccines containing Tetanus (Quinvaxem) and/or Diphtheria (Quinvaxem) toxoids, although the IOM concluded that the evidence is inadequate to accept or reject a casual relation between these conditions and vaccination.
For infants or children at higher risk for seizures than the general population, an appropriate antipyretic may be administered (in the dosage recommended in its prescribing information) at the time of vaccination with a vaccine containing an acellular Pertussis (Quinvaxem) component (including Quinvaxem) and for the following 24 hrs, to reduce the possibility of post-vaccination fever.
Hypotonic-hyporesponsive episodes (HHEs) rarely follow vaccination with whole cell Pertussis (Quinvaxem) containing DTP vaccines and occur even less commonly after acellular Pertussis (Quinvaxem)-containing DTP vaccines and DT vaccine. A history of HHEs is not contraindication to the use of acellular Pertussis (Quinvaxem) vaccines but recommends caution in these cases.
Use in pregnancy & lactation: Quinvaxem should not be administered to pregnant and nursing women.
Use in children: The potential risk of apnea and the need for respiratory monitoring for 48-72 hours should be considered when administering the primary immunization series to very premature infants (born ≤28 weeks of gestation) and particularly for those with a previous history of respiratory immaturity. As the benefit of vaccination is high in this group of infants, vaccination should not be withheld or delayed.
Use in the
Elderly: Quinvaxem is not indicated for use in adult and elderly patients.
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
