Diphtheria is an acute, toxin-mediated disease caused by bacteria called Corynebacterium Diphtheriae. It lives in the mouth, throat and nose of an infected person and can be spread to others by coughing or sneezing. A child with diphtheria can infect others for 2 to 4 weeks. The incubation period of diphtheria is 2–5 days (range, 1–10 days). Depending on the site of disease Diphtheria is of following type;

• Anterior Nasal Diphtheria
• Pharyngeal and Tonsillar Diphtheria
• Laryngeal Diphtheria
•  Cutaneous (Skin) Diphtheria

Diphtheria can initially cause a sore throat, fever and chills. But if it is not properly diagnosed and treated it produces a toxin (poison) that can cause serious complications such as heart failure or paralysis. About 1 person out of 10 who get diphtheria dies from it.

DESCRIPTION

Diphtheria is an acute, toxin-mediated disease caused by bacteria called Corynebacterium Diphtheriae. It lives in the mouth, throat and nose of an infected person and can be spread to others by coughing or sneezing. A child with diphtheria can infect others for 2 to 4 weeks. The incubation period of diphtheria is 2–5 days (range, 1–10 days). Depending on the site of disease Diphtheria is of following type;

• Anterior Nasal Diphtheria
• Pharyngeal and Tonsillar Diphtheria
• Laryngeal Diphtheria
• Cutaneous (Skin) DiphtheriaDiphtheria can initially cause a sore throat, fever and chills. But if it is not properly diagnosed and treated it produces a toxin (poison) that can cause serious complications such as heart failure or paralysis. About 1 person out of 10 who get diphtheria dies from it.

DOSAGE AND ADMINISTRATION

For the purpose of primary immunization it is recommended that 3 doses each of 0.5 ml should be inoculated on 3 separate occasions at 4 weeks interval.
The first dose should be given at approximately 6 weeks of age.
Although it is recommended that immunization be started at 6 weeks, if for any reason it is delayed, the same schedule may be used up to the sixth birthday.
DPT vaccine should be administered by deep intramuscular injection. The preferred site for injection is the anteriolateral aspect of the upper thigh.
Only sterile needles and syringes should be used for each injection. The vaccine should be well shaken before use.
Each injection of the primary immunization series should be made into a different site with a sterile disposable syringe and needle.

WITHDRAWING THE VACCINE FROM A SEALED GLASS AMPOULE
Shake the ampoule to disperse the contents thoroughly immediately before withdrawing the dose. Tap the ampoule to ensure that the solution is in the lower portion rather than in the neck of the ampoule. Wipe the neck of the ampoule with a suitable antiseptic using a sterile piece of cotton break off the top of the ampoule at the constriction by thumb pressure.

WITHDRAWING THE VACCINE FROM A RUBBER STOPPERED VIAL
Do not remove the rubber stopper from the vial.

Shake the vial to disperse the contents thoroughly immediately before each withdrawal of vaccine. Apply a sterile piece of cotton moistened with a suitable antiseptic to the surface of the rubber stopper and allow to dry. Draw into the sterile syringe a volume of air equal to the amount of vaccine to be withdrawn from the vial. Pierce the centre of the rubber stopper with the sterile needle of the syringe. Invert the vial, slowly inject into it the air contained in the syringe, and keeping the point of the needle immersed. Withdraw into the syringe the required amount of vaccine. Then hold the syringe plunger steady and withdraw the needle from the vial.
Carefully insert the needle intramuscularly at the prepared injection site. In order to avoid intravenous injection, pull back the plunger of the syringe to make certain that no blood is withdrawn before injecting the desired dose.

SCHEDULE

ADVERSE EVENTS

Mild local reactions consisting of erythema, pain and tenderness, swelling and indurations at the injection site are common, usually self-limited and subside without treatment. Persistent nodules at the site of injection have occurred following the use of an adsorbed vaccine, but this complication is unusual. Abscess at the site of injection has been reported (6-10 per million doses).
Mild to moderate systemic reactions occur frequently following injections of this vaccine. These usually consist of one or more of the following symptoms and signs: temperature elevation 38°C, drowsiness, fretfulness, anorexia, vomiting, and irritability, persistent or unusual crying. These symptoms are most frequent during the first 24 hours following vaccine injection and may persist for one to two days. The following adverse reactions high fever (40.5°C), collapse, screaming episodes, convulsions, signs of encephalopathy which can be serious and, occasionally fatal have been reported following administration of preparations containing pertussis vaccine. The incidence of these reactions is unknown, but they seem to be exceedingly rare, if any of these reactions occur, further immunization against pertussis is contraindicated. See also Contraindications and Precautions.

Sudden-infant-death-syndrome (SIDS) has been reported following administration of vaccine containing diphtheria, tetanus toxoids and Pertussis vaccine. The significance of these reports is not clear. It should be borne in mind that the three primary immunizing doses of these vaccines are usually administered to infants between the age of 6 weeks and 6 months and that approximately 85% of SIDS cases occur in the period from one to six months of age with the peak incidence at age two to four months.

CONTRAINDICATIONS AND PRECAUTIONS

DPT Vaccine (Adsorbed) should not be administered to infants or children with high fever, or other evidence of acute illness or infection. The presence of an evolving or changing neurological disorder is a contraindication to receipt of this vaccine. While data to support exclusion of pertussis immunization because of a family history of convulsive or other neurological disorders are scarce, a personal or family history of central nervous system disease or convulsions is considered a contraindication to use of this vaccine. Occurrence of any of the following signs, symptoms or conditions following administration is a contraindication to further use of this product and or pertussis vaccine as the single antigen: fever over 40°C (104°F); convulsion(s) with or without accompanying fever; alterations of consciousness; focal neurologic signs; screaming episodes; shock; collapse; thrombocytopenia purpura.

PRECAUTIONS AND WARNING

Individuals receiving corticosteroids or other immunosuppressive drugs may not develop an optimum immunologic response. This product should be used only for infants and children from 6 weeks through six years of age. The possibility of allergic reactions in individuals sensitive to the components of the vaccine should be borne in mind. Adrenaline injection (1:1000) should be kept ready for immediate use in case an anaphylactic or acute hypersensitivity reaction occurs. Frequent booster doses of tetanus toxoids in the presence of adequate or excessive serum levels of tetanus antitoxin have been associated with increased incidence and severity of reactions and should be avoided. If hypersensitivity to the diphtheria component is suspected, tetanus toxoids  should be used for reinforcing doses.
A separate sterile syringe and needle should be used for each individual patient to prevent the transmission of hepatitis or other infectious agents.

STORAGE

Diphtheria, Tetanus and Pertussis Vaccine (Adsorbed) should be stored at a temperature between 2°C and 8°C (35° to 46°F).
NOT TO BE FROZEN.
Product which has been exposed to freezing should not be used.

PRESENTATION

Each dose of 0.5 ml contains:

Diphtheria, Tetanus and Pertussis Vaccine (Adsorbed) is supplied, ready for use, in rubber-stoppered multi-dose vials, and in single-dose glass ampoules.

·         0.5 ml X 10 ampoules box

·         0.5 ml X 50 ampoules box

·         5 ml – 10 dose single vial carton

·         5 ml – 10 dose X 50 vials box