Antigangrene serum

antigangrene serum, LIQUID

Concentrated antigangrene serum is composed of purified polyvalent proteins fraction of the equine serum containing specific immunoglobulins. This serum is obtained from horses been hyper-immunized with anatoxins (toxins) mix of three main agents, responsible for the symptoms of septic anaerobic infection (A-type Cl. perfringens, Cl. novii (edematiens), and Cl. septicum). The serum contains purified peptides with 0.1% of chloroform as a preservative. The serum is supplied as a liquid polyvalent formulation. One ampoule in the pack contains mixture of anti-toxins against 3 causative agents, which are common for clinical cases of gas gangrene. Another ampoule in the kit is supplied with a single preventive dose of the serum. The volume of serum per each ampoule depends on the established activity of the preparation.

Biological and immunobiological properties: Therapeutical effect of polyvalent antigangrene serum is provided by the specific antibodies contained in the preparation. The antibodies selectively neutralize the toxins derived by propagating anaerobic microbes (A-type Cl. perfringens, Cl. novii, Cl. edematiens and Cl. septicum).

Directions: Antigangrene serum may be used both to treat or prevent development of the “gas gangrene” and some syndromes resulted from septic infections such as anaerobic sepsis, pulmonary gangrene etc. Prior the vaccinating, the probe for individual sensitivity must be taken with intracutaneous injection of horse serum (0.1 ml, 1:100), administered to the inner elbow area. Then, the reaction is recognized as a negative, if in 30 min the spot area of injection is appears like having less than 1 cm in diameter. Serum has to be administered to the patient in the possibly shortest time after getting injuries. Prophylactic dose (30000 IE) may be administered with intramuscular injection. If the reaction of individual sensitivity shown as positive (> 1 cm in diameter) then the serum must be administered gradually with several dilutions of 0.1 ml of serum in 9.9 ml of PSS. The doses to test allergic response are 0.5 ml, 2 ml and 5ml. If these doses are well tolerated then the final test is performed with intramuscular injection of 0.1 ml of antigangrene serum followed by complete therapeutic dose.
Clinical treatment of gangrene with the serum is featured as a slow intravenous infusion of the serum (150000 IE), diluted with equal volume of preheated to 36.5 C PSS. The speed of perfusion is 5 min for the first 1 ml of serum, then infusion is continued with 1 ml/min.

Contraindications: There are no known contraindications to use the preparation of antigangrene serum.

Side effects and Reactions to the serum: In some cases, the administering of the serum might be associated with several side effects, which can be divided into the three classes: short term reaction is developing right after the serum injection; mid-term reaction develops in 4-5th days after the treatment and time-delayed reaction (becomes detectable in 2 or more weeks after injecting the serum). Those reactions may correspond with symptoms of fever, chills, light convulsions, skin rash and minor impairments of cardiac-vascular activity. Such an effects may last from several hours to several weeks (very rare the person’s collapse might be observed). If the antigangrene serum injection is followed by developed anaphylactic reaction or the other shock symptoms, the patient should immediately be administered with subcutaneous injection of adrenaline (1:1000; 0.3-1 ml) or ephedrine (5%; 0.1-1 ml), depending on the person’s age. In the severe cases the intravenous administrating of these drugs might be recommended. Further guidelines and recommendations include intravenous administrating of Novocain (0.5% solution; 1-8 ml), calcium chloride (10% solution; 3-10 ml) and glucose solution (20-40%; 20-50 ml). Hormone drugs like prednisolone, prednisone, hydrocortisone and the others like cordiamine, caffeine, camphora might be recommended too. Upon the severity of the patient’s shock condition could be considered the treatment with slow intravenous infusion of 0.9% NaCl (300-500 ml) supplied with 0.3-0.5 ml of adrenaline (1:1000).

Formulation and package: Each package with Antigangrene serum contains two ampoules: one vial with single preventive dose of the serum (30 000 international units (IE) activity against: Cl. perfringens — 10 000 IE, Cl. oedematiens — 10 000 IE, Cl. septicum — 10 000 IE.); second vial contains prediluted (1:100) horse serum to examine patient’s individual sensitivity toward the equine proteins.

Storage and transportation: Store the serum in dry place at 5  3°C, keep it away from day light. After repeated cycles of freezing and thawing the serum is suitable for usage if its physical properties are retained.