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Antibotulinus serum

antibotulinus sera to ANATOXINS OF typeS A, B, C, E and F

Type A, B, C, E and F antibotulinus sera are formed of protein fractions isolated from equine or cattle blood hyperimmunized with either mix of botulinus anatoxins (types A, B, C, E and F) or every one of them separately. Each type of serum is purified, concentrated and fractionated after enzimatical digestion of peptides, following with salt precipitating. 0.5% Chloroform is used as a preservative. The serum might be a polyvalent preparation, containing the mix of types A, B, C, E and F botulinus antitoxins, or monovalent preparations, which contain the particular type of botulinus antitoxin. Since in Russia the prevalence of Cl. botulinum (types A, B, E) has been registered, mainly those types of antibotulinus serum are manufactured. Every vial of both mono- and polyvalent serum contains a single therapeutic dose, i.e. for types A, C, E - 10,000 IU; for type B - 5000 IU; and 3000 IU for type F. The serum volume per each ampoule actually depends on the serum activity. The content appears as a transparent or slightly opalescent, colorless or lightly yellow fluid with no flakes or pellets.

Biological and Immunological Properties: The preparation contains polypeptides – antitoxins, which effectively neutralize the botulinus toxins of particular types.

Directions: Sera may be used for therapy, urgent prevention and clinical treatment of the botulism.

Administering: The antibotulinus sera could administered for either therapeutic and/or preventive aim. For the therapeutic purpose the chosen kind of serum should be injected in a shortest time after the first signes and symptoms of botulism have been developed. Several preparations of monovalent serum of different types or a polyvalent serum are used for the urgent treatment of botulism, caused by unknown type of toxic agent (microorganism). When the type of the toxin (causative agent) is known, the corresponding monovalent serum may be used. For the prophylactics is used only one half of the dose for treatment (of every single ampoule), which is applied by intramuscular injection.
For clinical treatment of the botulism the one dose is dissolved with 200 ml of 0.9% of NaCl, preheated at 37°C. The serum solution is applied by intravenous infusion at the rate of 60-90 drops per min. It is a good idea to administer the 90 mg of prednizalone prior to infusion of the serum, which allows to minimize possible allergic outbrakes.

Side Effects and Reactions: Some nonspecific allergic reactions may be developed due to administration of antibotulinus sera: short term reactions are developed in several hours after serum injection; mid-term reactions are developed in 2-8th days; remote reaction are developed on the second week or later. These reactions might have symptoms, similar to either serum type disease or rarely as anaphylactic shock of hyper-reactive patients. For the very reason, each person taken the serum has to be closely observed for 30 min after injection. Proper equipment for antishock therapy should also be available. The sera administering should be properly registered, indicating the dose, way of applicating, the time, patient’s reaction, the serum lot number, the flask, the control number and the name of manufacturer.

Package: Ampoules contain a single dose, equal to one dose of each monovalent antibotulinus serum. One pack contains 5 ampoules of serum (all different or the same type) and 5 ampoules of diluted for 1:100 serum, which is to determine the sensitivity of the patient to sera components. A vial with polyvalent antibotulinus serum consists of an ampoule with one therapeutic dose of the mix of all the types of the toxins. One pack contains one ampoule with the serum and one ampoule with serum diluted for 1:100 to determine an individual sensitivity to the preparation.

Storage and Shipment: Store at 3-5oC. Serum after one freezing/thawing cycle may be used if the content’s properties are not changed. Shipping is allowed by any transports with the roof at 3-5oC. Serum shelf life is for 2 years.