Diphtheria, Tetanus And Pertussis Vaccine Adsorbed
 

DESCRIPTION
Diphtheria, Tetanus and Pertussis Vaccine Adsorbed is prepared by combining purified Diphtheria toxoid, purified Tetanus toxoid and killed Bordetella pertussis bacilli. The antigens are adsorbed onto aluminium phosphate as adjuvant. Thiomersal is added as preservative. The vaccine has the appearance of a greyish - white suspension and does not contain any horse serum protein. Therefore it does not induce sensitization to sera of equine origin. The vaccine meets the requirements of WHO, EP and IP when tested by the methods outlined in WHO, TRS. (1990), 800, EP and IP.

POTENCY
Each single 0.5 ml human dose contains
Diphtheria Toxoid 25Lf ( 30 IU)
Tetanus Toxoid 5Lf ( 40 IU)
B. Pertussis 16 OU ( 4 PU)
Adsorbed on Aluminium Phosphate (AlPO4) 1.5 mg.
Preservative : 0.01% Thiomersal

INDICATIONS
For the primary immunization of infants, above the age of six weeks, and of pre-school children against diphtheria, tetanus and whooping cough. The vaccine can be safely and effectively given simultaneously with BCG, Measles, Polio vaccines (IPV and OPV), Hepatitis B and Yellow Fever vaccine, Haemophilus influenzae-B and Varicella vaccine..

APPLICATION AND DOSAGE
For the purpose of primary immunization it is recommended that 3 doses of 0.5 ml should be inoculated on 3 separate occasions at 4 to 6 week intervals. The first dose should be given at approximately 6 weeks of age. Reinforcing injections of 0.5 ml. should be given 12 months after the primary immunization and also between the ages of 4 to 6 years.

METHOD OF INOCULATION
DTP vaccine should be injected intramuscularly. The anterolateral aspect of the upper thigh is the preferred site for injection. (an injection into a child's buttocks may cause injury to the sciatic nerve and is not recommended). It must only be injected into the skin as this may give rise to local reaction. Only sterile needles and syringes should be used for each injection. The vaccine should be well shaken before use.
Once opened, multi-dose vials should be kept between +2°C and +8°C. Multi-dose vials of DTP from which one or more doses of vaccine have been removed during an immunisation session may be used in subsequent immunisation sessions for upto a maximum of 4 weeks, provided that all of the following conditions are met
The expiry date has not passed
The vaccines are stored under appropriate cold chain conditions
The vaccine vial septum has not been submerged in water
Aseptic technique has been used to withdraw all doses

REACTIONS
Mild, local reactions such as pain, tenderness, erythema, induration are common and may be associated with temperature elevation (38-39°C) and an infiltration of 3 to 4 cm in diameter. Other reactions that may be observed include chills, irritability persistent crying in infants and general malaise, Most reactions last for 24 to 48 hours: In such cases the use of antipyretics and in the case of local reaction, cold compresses should be considered. Occasionally a nodule may develop at the site of injection but this is without any harmful effects. More serious reactions such as fever above 40°C excessive screaming, and encephalopathic symptoms (e.g. convulsions) may also be observed but are extremely rare. By strict observance of the contraindications listed below the number of such complications will be reduced to a minimum.

PRECAUTIONS
ADRENALINE INJECTION (1:1000) MUST BE IMMEDIATELY AVAILABLE SHOULD AN ACUTE ANAPHYLACTIC REACTION OCCURS DUE TO ANY COMPONENT OF THE VACCINE. For
treatment of severe anaphylaxis the initial dose of adrenaline is 0.1-0.5 mg (0.1-0.5ml of 1:1000 injection) given s/c or i/m. Single dose should not exceed 1 mg (1ml). For infants and children the recommended dose of adrenaline is 0.01mg/kg (0.01ml/kg of 1:1000 injection). Single pediatric dose should not exceed 0.5mg (0.5ml). The mainstay in the treatment of severe anaphylaxis is the prompt use of adrenaline, which can be lifesaving. It should not be used at the first suspicion of anaphylaxis.
As with the use of all vaccines the vaccines should remain under observation for not less than 30 minutes for the possibility of occurrence
of immediate or early allergic reactions. Efcorlin hydrochloride and antihistaminics should be available in addition to supportive measures such as oxygen inhalation.
There is an increased incidence of local and systemic reactions to booster doses of tetanus toxoid when given to previously immunized persons. Special care should be taken to ensure that the injection does not enter a blood vessel.
IT IS EXTREMELY IMPORTANT WHEN THE PARENT, GUARDIAN, OR ADULT PATIENT RETURNS FOR THE NEXT DOSE IN THE SERIES, THE PARENT, GUARDIAN, OR ADULT PATIENT SHOULD BE QUESTIONED CONCERNING OCCURRENCE OF ANY SYMPTOMS AND/OR SIGNS OF AN ADVERSE REACTION AFTER THE PREVIOUS DOSE.


DRUG INTERACTIONS
If DTP and TIG or Diphtheria Antitoxin are administered concurrently, separate syringes and separate sites should be used.
As with other intramuscular injections, use with caution in patients on anticoagulant therapy.
Immunosuppressive therapies, including irradiation, antimetabolites, alkylating agents, cytotoxic drugs and corticosteroids used in greater than physiologic dose may reduce the immune response to vaccines.


CONTRAINDICATIONS AND WARNINGS
Not for intradermal use. The administration of pertussis containing vaccine is contraindicated in children with a personal, or family history in parents or siblings of idiopathic epilepsy or other familial or hereditary diseases of the central nervous system. Administration of pertussis vaccine is also contra-indicated in children with a history of seizures, convulsions, cerebral irritation in the neonatal period, developmental neurological defect or other disorder of the central nervous system.
Immunization should be postponed if the infant has an acute disease. However, low grade fever, mild respiratory infections, malnutrition or diarrhoea should not be considered as contraindications. Infants who have active or progressive neurological disease including recent convulsions should not be given pertussis-containing vaccines. Adsorbed DT vaccine should be given instead. A second or subsequent dose of DTP vaccine should not be given to a child who had a severe reaction like persistent screaming, shock, convulsions or encephalopathy to the previous dose. Adsorbed DT vaccine should be given for the remainder of the course.

HIV INFECTION
DTP vaccine may be used in children with known or suspected HIV infection. Although the data are limited and further studies are being encouraged, there is no evidence to date of any increased rate of adverse reactions using this vaccines in symptomatic or asymptomatic HIV infected children.

STORAGE OF THE VACCINE
The vaccine should be stored in a dry, dark place at a temperature between 2-8°C. Transportation should also be at 2-8°C. DO NOT FREEZE.

SHELF LIFE
24 months from date of manufacture.

PRESENTATION
1 Dose ampoule of 0.5 ml
10 Dose vial of 5 ml
20 Dose vial of 10 ml

Copyright © 2009 Serum Institute of India Limited. Legal Disclaimer.