as follows
Definition of technical terms of tetanus antitoxin
English name: definition of tetanus antitoxin: a specific antibody that can neutralize tetanus toxin. Applied discipline: immunology (first-class discipline); Immunopathology and clinical immunology (two disciplines); The above contents of infectious immunity (third-level discipline) shall be examined and published by the National Committee for the Examination and Approval of Scientific and Technical Terminology.
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The titer of tetanus antitoxin in horse plasma immunized with tetanus toxoid should not be lower than per 1 ml 1000 international units. Diluting with water, adding pepsin for digestion, salting out the digestive juice with ammonium sulfate, adsorbing with alum, concentrating, adjusting the contents of sodium chloride and protein, adding an appropriate amount of preservative, adjusting pH value, sterilizing and filtering, and aseptic filling.
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Matters needing attention Expand and edit the basic information of this paragraph.
Pinyin name: Poshanfeng antitoxin English name: tetanus antitoxin PageNo. : 2000 edition II-115 This strain was made from horse plasma immunized with tetanus toxoid by enzyme digestion and salting out. Category: antiserum. Specification: (1) 1500 international units (for prevention) (2) 10000 international units (for treatment)
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This product is a colorless or yellowish clear liquid, which can precipitate a small amount of precipitate and shake it off after a long time.
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The identification of this product should be able to neutralize tetanus toxin or have obvious immunoprecipitation reaction by using tetanus toxin neutralization test or immunodiffusion test according to China Biological Products Regulations. Immunodiffusion test with rabbit anti-horse plasma immunoglobulin should show immunoprecipitation reaction. Check the following items according to the method specified in China Biological Products Regulations. The pH value should be 6.0 ~ 7.0. Sodium chloride should be 0.75% ~ 0.95% (g/ml). Ammonium sulfate shall not exceed 0.65438 0% (g/ml). If the preservative is chloroform, it shall not exceed 0.5% (ml/ml); In the case of thiomersal, it shall not exceed 0.0 1% (g/ml); In the case of m-cresol, it shall not exceed 0.25%(g/ml). The total protein shall not exceed 17% (g/ml). Albumin diluted the product to 2% protein concentration and analyzed it by agarose electrophoresis. It should contain no or only protein with minimal albumin mobility. Take this product for specific activities and check it according to law. Tetanus antitoxin per kloc-0/g protein shall not be less than 35,000 international units (for preventive use) or 45,000 international units (for therapeutic use). F(ab')2 Take this product and determine it according to law. The content of F(ab')2 in preventive antitoxin is not less than 50%, and the content of F(ab')2 in therapeutic antitoxin is not less than 60%. Take this product as a blood group A substance and determine it by hemagglutination inhibition method. Every 1 ml contains blood substance type A, which shall not exceed 4 micrograms ... This product is considered as abnormal toxicity, and it should meet the requirements after inspection according to law. Take pyrogen of this product, inject 3ml per 1kg according to the weight of the rabbit, and check according to the law, which should meet the requirements. Sterile products, inspection according to law, should comply with the provisions. Take this product for titer determination, and determine it according to the method specified in China biological products regulations. Each 1 ml contains not less than 2000 international units (for preventive use) or 3000 international units (for therapeutic use).
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Store in the dark at 2 ~ 8℃. 20% over-packaging, valid for 5 years; 10% over packaging, valid for 3 years.
Pharmacological effects of editing this paragraph
The product contains specific antibody, has the function of neutralizing tetanus toxin, and can be used for preventing and treating Clostridium tetanus infection.
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Can be used for preventing and treating tetanus. When tetanus or its suspicious symptoms appear, antitoxin treatment should be used in time while undergoing surgery and other treatments. Open trauma (especially those with deep wounds and serious pollution) should be prevented in time when there is a risk of tetanus infection. Anyone who has been immunized with tetanus toxoid should be injected with 1 needle toxoid to strengthen the immunity after injury, and antitoxin is not necessary; Those who have not received toxoid immunization or have unclear immunization history must be injected with antitoxin, but they should also start toxoid vaccination at the same time to obtain lasting immunity.
Edit the usage and dosage of this paragraph.
Usage: Subcutaneous injection should be at the attachment of deltoid muscle of upper arm. When injecting toxoid at the same time, the injection sites must be separated. Intramuscular injection should be in the middle of deltoid muscle of upper arm or upper part of gluteus maximus. Intravenous injection can only be done if there is no response after subcutaneous or intramuscular injection. Intravenous injection should be slow, not exceeding 1 ml at first, and not exceeding 4 ml per minute thereafter. An intravenous injection should not exceed 40ml, and the child's weight per kloc-0/kg should not exceed 0.8ml. The antitoxin can also be added into glucose injection and sodium chloride injection for intravenous drip. Before intravenous injection, ampoules should be heated to near body temperature in warm water. If there is any abnormal reaction during the injection, the drug should be stopped immediately. Dosage: 1. Prevention: 1 subcutaneous or intramuscular injection 1500 ~ 3000 IU, with the same dose for children and adults; In severe cases, the dosage can be increased by 1 ~ 2 times. After 5 ~ 6 days, if the risk of tetanus infection is not eliminated, it should be injected again. 2. Treatment: intramuscular or intravenous injection of 50000~200000IU 1 time, with the same dose for children and adults; In the future, the dosage and interval of injection will be decided according to the condition, and an appropriate amount of antitoxin will be injected into the tissues around the wound. Neonatal tetanus, intramuscular or intravenous injection of 20000 ~ 100000 iu within 24 hours. Drugs for pregnant and lactating women are not clear.
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1. Anaphylactic shock: It can occur suddenly during injection or within several minutes to several minutes after injection. The patient suddenly showed depression or irritability, pallor or flushing, chest tightness or asthma, cold sweat, nausea or abdominal pain, rapid pulse, decreased blood pressure, and even coma and collapse. If not rescued in time, he may die soon. If the patient's eyes itch, it means that the allergic reaction has spread to the whole body. Mild patients can be relieved after injection of adrenaline; In severe cases, oxygen should be given, antihypertensive drugs should be used to maintain blood pressure, and antiallergic drugs and adrenocortical hormones should be used for rescue. 2. Seropathy: The main symptoms are urticaria, fever, lymphadenopathy, local edema, occasional proteinuria, vomiting, joint pain, erythema at the injection site, itching and edema. It usually occurs 7 ~ 14 days after injection, which is called delayed type. It also occurs 2 ~ 4 days after injection, which is called accelerated type. Serum sickness should be treated symptomatically, and calcium or antihistamine can be used. Generally, it can be cured in a few days to ten days. If the allergy test is positive, use it with caution. See desensitization injection for details.
Notes for editing this paragraph
1. This product is a liquid product. Products such as turbid ampoules with unshakable deposits, foreign objects, cracks and unclear labels cannot be used. Ampoules should be used up once after opening. 2. Each injection shall be recorded in detail, including name, gender, age, address, injection times, reaction after the last injection, results of this allergy test and reaction after injection, name and batch number of the antitoxin manufacturer used, etc. 3. Injection equipment and injection sites should be strictly disinfected. Syringes should be dedicated. If it cannot be used alone, it should be thoroughly cleaned after use, preferably dry-baked or autoclaved. When injecting toxoid at the same time, the syringes must be separated. 4. When using antitoxin, special attention should be paid to prevent allergic reaction. Before injection, you must do an allergy test and ask about your past allergy history in detail. Anyone who has a history of bronchial asthma, hay fever, eczema or angioneurotic edema, or who is allergic to certain substances, or who has been injected with horse serum preparation in the past, must be especially alert to allergic reactions. (1) allergy test: the antitoxin was diluted with sodium chloride injection (0. 1ml antitoxin plus 0.9ml sodium chloride injection) 10 times, and 0.05ml was injected into the skin of the front palm for 30 minutes. If there is no obvious reaction at the injection site, it is negative, and antitoxin can be injected directly under close observation. If there is elevation increase, redness, swelling and infiltration at the injection site, especially those with pseudopodia or itching, it is a positive reaction and must be injected by desensitization method. If the local reaction is particularly serious or accompanied by systemic symptoms, such as urticaria, nasopharyngeal itching, sneezing, etc. It is a strong positive reaction and antitoxin should be avoided. If you must use it, you should use desensitization injection to prepare for rescue. Once anaphylactic shock occurs, rescue should be carried out immediately. Those who have no allergic history or negative allergic reaction are not without the possibility of anaphylactic shock. For the sake of prudence, a small amount can be injected subcutaneously for the test. After observing no abnormal reaction for 30 minutes, a sufficient amount can be injected subcutaneously or intramuscularly. (2) Desensitization injection method: Under normal circumstances, sodium chloride injection can be used to dilute antitoxin 10 times, and a small amount of subcutaneous injection will be made for several times, and observation will be made for 30 minutes after each injection. 0.2ml of antitoxin diluted 1 0 can be injected for the first time, 0.4ml for the second time when there is no cyanosis, asthma or obvious shortness of breath, and 0.8ml for the third time if there is still no response. If there is still no response, undiluted antitoxin in ampoules can be injected subcutaneously or intramuscularly. For those with allergic history or strong positive allergic test, the dosage of 1 injection should be appropriately reduced and then increased, and injected several times to avoid violent reaction. 5. Outpatients must be observed for 30 minutes before leaving after injecting antitoxin.