Indications And Clinical Uses: For active immunization against diphtheria.
Dosage And Administration: For Infants, Pre-School and School Children: For infants over 6 months of age and children, it is recommended that 3 s.c. doses of 1 mL be administered with an interval of 4 weeks between the first, second and third doses.
Reinforcing Doses: Blood serum of children 2 to 5 years following 3 doses of diphtheria toxoid has shown significant reduction in diphtheria antitoxin content during successive years; and Schick tests made at long intervals following immunization against diphtheria have shown a significant proportion of reversions to the “Schick-positive” state. These findings are not surprising in view of the fact that even among those who recover from diphtheria a considerable number become again susceptible to the disease. Obviously, however, it is desirable that children who were immunized against diphtheria in infancy or during pre-school years should have their immunity reinforced.
It is recommended that a dose of 1 mL of diphtheria toxoid be given s.c. after a period of about 1 year following the initial course of 3 doses and again about 4 years later, at about 5 years of age. At school age an additional reinforcing dose of 0.1 to 0.2 mL is recommended for those who have been immunized according to the above schedule. This small dose can be given without being preceded by a reaction test. For those of school age who have not received reinforcing doses after their primary immunization a full dose of 1 mL, preceded by a reaction test, should be given.
For Older Children and Adults: Under certain circumstances it may be desirable or necessary to immunize older children (over 8 years) or adults who have not been previously immunized or for whom records of previous immunization are lacking. Such a procedure is complicated by the fact that local or general reactions to the toxoid may be encountered. These reactions are due to sensitivity to the diphtheria protein and are seldom encountered in infants or children of pre-school age.
In order to avoid such reactions, a “reaction test” should therefore be carried out before giving a regular course of injections to older children or adults. For this purpose, Diphtheria Toxoid for Reaction Test (diluted toxoid) is supplied in this package. Diphtheria Toxoid for Reaction Test is also available in packages of 5 ampuls, each ampul sufficient for testing up to 5 persons at one time in connection with immunization programs.
Method of Performing the Reaction Test: In making a reaction test, an essential is a suitable 1 mL syringe graduated in tenths and equipped with a fine needle (gauge 26 or 27), both properly sterilized. The test is made by injecting intradermally, in the flexor surface of the forearm, 0.1 mL of the diluted diphtheria toxoid supplied for the test. If, within 48 hours, no redness has developed at the site of injection or if an area of redness less than 13 mm in diameter with no induration has developed, the usual dose of diphtheria toxoid may be given. If, however, redness of more than 13 mm in diameter, or induration is present, it is recommended that use be made of smaller doses, or of the Diphtheria Toxoid Diluted for Immunization of Reactors which is available from the Laboratories.
The diphtheria toxoid supplied for reaction tests is identical with that which is supplied by these Laboratories for use as a control in making Schick tests. Hence, a complete Schick test including this control may be used to determine sensitivity as well as susceptibility, and is desirable prior to giving a series of injections of diphtheria toxoid to an adolescent or an adult, particularly in view of the fact that a significant proportion of adolescents and adults is immune to diphtheria.
Method of Inoculation: The preparation should be administered by s.c. injection. The injection may conveniently be made into s.c. tissue near the insertion of the deltoid muscle. The site of injection should be prepared with a suitable antiseptic.
If sterile disposable syringes and needles are not used, syringes and needles should be sterilized in an autoclave at 121°C for 30 minutes. Failing that they should be boiled for at least 20 minutes. Care should be taken to maintain sterility until used.
In the inoculation of groups of persons, a separate sterilized needle must be used for each injection. Wiping the needle with alcohol is inadequate for its sterilization.
Withdrawing the preparation from a sealed glass ampul: Tap the ampul to ensure that the solution is in the lower portion rather than in the neck of the ampul. Wipe the neck of the ampul with a suitable antiseptic. Using a sterile piece of cotton or a sterile towel, break off the top of the ampul at the colored line (no file is required). Then with the sterile syringe and needle withdraw the contents of the ampul into the syringe, holding the ampul in such a way that the point of the needle is kept immersed throughout the withdrawal.
Once the ampul has been opened, any of its contents not used immediately should be discarded.
Withdrawing the preparation from a rubber-stoppered vial: Do not remove the rubber stopper from the vial.
Apply a sterile pledget of cotton moistened with a suitable antiseptic to the surface of the rubber stopper and allow it to act for at least 5 minutes. Draw into the sterile syringe a volume of air equal to the amount of the preparation to be withdrawn from the vial. Pierce the center 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 the preparation. Then hold the syringe-plunger steady and withdraw the needle from the vial.
Carefully insert the needle into the s.c. tissue. In order to avoid i.v. injection, pull back the plunger of the syringe to make certain that no blood is withdrawn before injecting the desired dose.
Availability And Storage: A toxoid containing 50 Lf purified diphtheria toxoid/mL. Ampuls of 1 mL, boxes of 3 (including 1 ampul of Diphtheria Toxoid for Reaction Test). Vials of 10 mL; 5´1 mL ampuls for “reactors”; 5´0.5 mL ampuls for sensitivity test. Store at 2 to 8°C.
DIPHTHERIA TOXOID Connaught Diphtheria Prophylaxis
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