ANTI BACTERIAL

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Tetanus Antitoxin (ATS) – 1000 I.U/1500 I.U/3000 I.U – 1mL

Tetanus Antitoxin 1000 IU / 1500 IU / 3000 IU (1 ml vial)
( Liquid)

Administration:

Tetanus antitoxin is given prophylactically to persons at the risk of tetanus infection by infected wounds or severe wounds. A dose of 1500 IU should be given intramuscularly or subcutaneously and the dose may doubled or trebled in case multiple and severe wounds. Prophylactic dose is also given in surgical operations as post operative care.

Along with this passive immunization it is advisable to initiate active immunization with adsorbed Tetanus toxoid.

Indications:

Tetanus antitoxin neutralizes the toxin produced by Clostridium tetani; the toxin has high affinity for new cells and antitoxin is unlikely to have an effect on toxin that is no longer circulating. Tetanus antitoxins have been used to provide temporary passive immunity against tetanus but tetanus immunoglobulins are preferred (Reynolds, 1990; McEvoy et al. 1988). Human globulin offers the advantage of greater protection, a lower risk of adverse effects and requires only one-tenth of the dosage compared to antitoxin of animal.

Sensitivity testing (e.g., skin test, conjunctival test) should be conducted in all individuals, regardless of clinical history, prior to administration of tetanus antitoxin.

In case of patients receiving tetanus antitoxin serum, it should be essential to test for hypersensitivity of the individual with a test dose.

Serum sensitivity test is carried out by injecting 0.1 ml serum in 1:10 dilution either subcutaneously or intracutaneously and observing for half an hour for any reactions of local or general. In case of hypersensitive reaction, serum should be given with great caution in small divided dose subcutaneously at regular intervals of half an hour. Injection adrenaline (1:1000) must be at hand for immediate treatment of shock, if it develops. Intravenous administration of serum is not recommended in hypersensitive cases.

In some cases symptoms as itching, urticarial rash, pains in joints and muscles, fever, enlargement of lymph glands, appear about 7-12 days after injection of serum. These should be treated with antihistamines and corticosteroids. Usually these symptoms of serum sickness last a few days and patients recover without any complication.

The liquid Tetanus antitoxin should be stored between 20C to 80C. It should not be allowed to freeze. Freeze-dried Tetanus antitoxin can be stored in a cool, dark place or in a refrigerator, if available. Reconstituted liquid should not be stored for a long time and should not be allowed to freeze.

Tetanus antitoxin is supplied as 1 ml liquid in glass vial/ ampoule and also supplied as freeze-dried powder with 1 ml of Water for Injection I.P. for reconstitution.

Left over antiserum and used vials should be discarded as biomedical waste.

Diphtheria Antitoxin (ADS) – 10,000 I.U –10 mL

Diphtheria Antitoxin 10000 IU (10 mL vial)
(Lyophilised/Liquid)

Composition: Each ml contains:

* 1000 I.U. Enzyme refined, equine immunoglobulin solution

* Cresol IP (Preservative): not more than 0.25%v/v

Use in Prophylaxis:

The use of Diphtheria Antitoxin is not recommended for prophylaxis as its protective effect is of short duration (1 to 2 weeks only) and furthermore, it may cause sensitization to horse sera. Instead, the contacts of Diphtheria patients should receive a dose (0.5 ml) of diphtheria vaccine (Diphtheria vaccine, Adsorbed PTAP) or adsorbed diphtheria- tetanus vaccine (D-T Vaccine, which protects against both diphtheria and tetanus.) and followed after 1 to 2 months with a second dose. Prophylaxis with diphtheria vaccine is gives protection for many years and is practically free from reaction.

Use in Treatment:

A dose of 10000 IU to 30000 IU of diphtheria antitoxin may be injected intramuscularly in mild to severe cases of diphtheria and up to 100000 IU in severe cases after testing serum sensitivity (see below for reactions to horse serum). In addition, antibiotics and corticosteroids may be administered. It is advised that after recovery from diphtheria, patients should be actively immunized for long term protection by the use of two doses at interval of 1 to 2 months with adsorbed diphtheria vaccine or with adsorbed diphtheria-tetanus vaccine.

Injection of diphtheria antitoxin in horse serum sensitive individuals can produce immediate reaction of acute anaphylaxis which could sometimes be fatal unless immediately countered by injecting 1 ml of 1:1000 adrenaline intramuscularly. Strict care should be taken to prevent this reaction. Before injection of diphtheria antitoxin, it is necessary to enquire from the patient: (1) whether he/she has had injections of any serum before, (2) whether there is personal or family history of allergy i.e. asthma, eczema or drug allergy. The sensitivity of the patient to the serum is tested by injecting subcutaneously 0.1 ml of diphtheria antitoxin diluted 1:10 and the patient is observed for 30 minutes for local and general reactions. If the test dose shows either local reaction such as wheal and flare or general anaphylactic reaction such as pallor, sweating, nausea, vomiting, urticaria or fall of blood pressure, these should be treated with 1 ml of 1:1000 adrenaline (which should be always be kept handy) before injecting the main dose of diphtheria antitoxin. Half the dose of adrenaline may be repeated 15 minutes later if necessary.

In allergic individuals, Diphtheria antitoxin is to be injected 15 to 30 minutes after administration of antihistamines such as injectable pheniramine maleate and injectable hydrocortisone intramuscularly. 1 ml of adrenaline (1:1000) may be injected intramuscularly at the same time as the antiserum. Administration of hydrocortisone or adrenaline may be repeated if necessary.

In some cases symptoms such as itching, urticarial rash, pains in joints and muscles, fever, enlargement of lymph gland appear 7-12 days after the injection of diphtheria antitoxin. These should be treated with antihistamines and corticosteroids. Usually these symptoms of serum sickness last a few days and the patients recover without any complications.

Diphtheria antitoxin should be stored at a temperature of between 2ºC and 8ºC. It should not be allowed to freeze.

Diphtheria antitoxin 10,000 I.U. in 10 ml vials.

Left over used empty vials should be discarded as biomedical waste.

Gas gangrene

Polyvalent Equine Purified Concentrated Liquid of Anti Gas Gangrene Sera

For prophylaxis (Sepsis, Oedema, Necrosis caused due to Clostridium perfringens, Cl.novyi (oedematiens), Cl.septicum)and Treatment of Gas Gangrene. The preparation is used for prevention and treatment of gas gangrene. As a preventive measure the serum is administered intramuscularly, whereas therapeutic administration is performed by means of intravenous infusion.

Shelf life: 2 years

Concentrated antigangrene serum is composed of purified polyvalent proteins fraction of the equine serum containing specific immunoglobulins. This serum is obtained from equines been hyper-immunized with anatoxins (toxins) mix of three main agents, responsible for the symptoms of septic anaerobic infection (A-type Cl. perfringens, Cl. novyi (oedematiens) and Cl. septicum). The serum contains purified peptides with Cresol < 0.25% v/v as a preservative. The serum is supplied as a liquid polyvalent formulation. One vial in the pack contains mixture of anti-toxins against 3 causative agents, which are common for clinical cases of gas gangrene.

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. novae (oedematiens) and Cl. septicum).

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 equines 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 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 (25000 I.U.) 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 I.U.), 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.

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 4-5 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 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).

Anti-Gas gangrene sera 25000 I.U./10mL is a liquid preparation that is supplied in a vial. Each package contains the vial along with the package insert.

Anti-Gas gangrene sera should be stored between 2 C and 8 C. DO NOT FREEZE. Protect from light.

Left over Anti-Gas gangrene sera and used empty vials should be discarded as biomedical waste.