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Concentrated liquid anti-diphtheria serum
(Serum antidiphthericum depuratum, concentratum fluidium)
Anti-diphtheria serum is a protein fraction isolated from blood of horses hyperimmunized with diphtheria anatoxin. The preparation is purified and concentrated by a method of peptic digestion and salt fractionation.
Anti-diphtheria serum is a transparent or slightly opalescence fluid colorless or yellowish.
Biological and Immunological Properties
One milliliter of the serum contains no less than 1500 international antitoxic units (IU) neutralizing diphtheria toxin. The preparation contains antitoxins that neutralize diphtheria toxin.
The serum is used for treatment of patients with diphtheria.
Administration and Dosage
In localized forms of pharyngeal diphtheria the serum is administered at a single dose of 10,000-20,000 IU. In toxic diphtheria it is given at a dose of 40,000-50,000 IU, in the 1st degree toxic diphtheria at a dose of 50,000-70,000 IU, in the 2nd degree toxic diphtheria at a dose of 60,000-80,000 IU, and in the 3rd degree toxic and hemorrhagic diphtheria at a dose of 100,000-120,000 IU.
In laryngeal diphtheria the preparation is given at a dose of 40,000-50,000 IU. Course doses are 2- to 2.5-fold higher than the single dose.
In the absence of effect the serum can be injected after 24 hours . During the first two days of toxic diphtheria the preparation is injected at 12-h intervals.
The serum is injected intramuscularly in the upper third of the anterior outer area of the thigh or in the glutei area.
Before the first injection of the serum an obligatory coetaneous test with horse serum diluted 1:100 (ampule marked with red) is performed to determine individual sensitivity to horse serum proteins.
Serum diluted 1:100 (0.1 ml) is injected in the flexing area of the forearm. The reaction is read after 20 min. The test is negative if the diameter of edema and/or hyperemia in the site of injection is less than 1.0 cm. The test is positive if the diameter is equal to or greater than 1.0 cm.
If the reaction is negative, 0.1 ml ant diphtheria serum (ampule marked blue) is injected subcutaneously in the middle area of the upper arm. In the absence of general and/or local reaction for (45"15) min, the prescribed dose of the serum is injected. Then the patient should be observed by a physician for one hour.
If the coetaneous test is positive and/or an adverse reaction to the first injection of 0.1 ml anti-diphtheria serum has developed, the preparation is administered only according to vital parameters. For desensitization serum diluted 1:100 is injected subcutaneously in doses 0.5 ml, 2.0 ml and 5 ml at 15-20-min intervals, after which undiluted serum is injected subcutaneously in doses 0.1 ml and 1.0 ml; in the absence of reaction the prescribed dose of the serum is injected. The anti-anaphylactic shock preparations are injected together with the first desensitizing dose. If the patient develops the anaphylactic shock symptoms in response of the above-mentioned doses, anti-diphtheria serum is administered under anesthesia.
Ampule opening and immunization are performed under strict aseptic and antiseptic conditions.
Partially used ampule is closed with a sterile cloth and stored at (20"2)oC for no longer than one hour.
Preparation in a cracked ampule or in ampule with damaged label as well as preparations with altered physical properties (color, transparence, flakes that cannot be disintegrated) are not allowed for use.
Adverse reactions
Allergic complications: anaphylactic shock and/or serum disease, have been reported. The means of antis hock therapy should be available.
Ampule containing 10,000 IU (one dose) or 20,000 IU (two doses). Pack contains 5 ampules of undiluted serum (marked blue) and 5 ampules of serum diluted 1:100 (marked red).
Storage and Shipment
Store at (5"3)oC. Protect from light and humidity.
Shipping by all means of covered transport at (5"3)oC.
Shelf life 2 years from the date of production.