Tetanus Antitoxin Instructions
　　Warning: Use with caution in individuals with positive allergy tests; see desensitization injection method for details.

　　[Drug Name] Generic Name: Tetanus Antitoxin
　　English Name: Tetanus Antitoxin
　　Pinyin: Poshangfeng Kangdusu
　　[Ingredients and Properties] Main ingredient: Equine tetanus immunoglobulin after pepsin digestion.
　　This product is a liquid antitoxin globulin preparation purified from plasma obtained from horses immunized with tetanus toxoid, after pepsin digestion.
　　Excipients: Sodium chloride, metacresol.
　　Dosage form: Injection.
　　Appearance: This product is a colorless or pale yellow clear liquid containing a small amount of preservative; prolonged standing may produce a small amount of easily dispersed precipitate.
　　[Vaccination Target] Individuals with open wounds (especially deep or heavily contaminated wounds) at risk of tetanus infection.
　　[Function and Use] This product contains specific antibodies that neutralize tetanus toxin and can be used for the prevention of Clostridium tetani infection.
　　[Specification] 0.75ml, 1500IU per vial.
　　[Immunization Schedule and Dosage]
　　Injection site: Subcutaneous or intramuscular.
　　Injection route: Subcutaneous injection should be at the deltoid attachment of the upper arm. Intramuscular injection should be in the middle of the deltoid muscle of the upper arm or the upper outer part of the gluteus maximus.
　　Dosage: A single subcutaneous or intramuscular injection of 1500~3000IU; the dose is the same for children and adults; for severe wounds, the dose can be increased 1~2 times. If the risk of tetanus infection is not eliminated after 5~6 days, repeat injection is recommended.
　　[Adverse Reactions] 1. Allergic shock: May occur suddenly during or within minutes to tens of minutes after injection. Patients may suddenly show depression or irritability, pale or flushed face, chest tightness or asthma, cold sweat, nausea or abdominal pain, rapid and weak pulse, low blood pressure, severe cases may have coma and collapse; without timely rescue, death can occur rapidly. Mild cases can be relieved after adrenaline injection; severe cases require fluid infusion, oxygen therapy, vasopressors to maintain blood pressure, and use of anti-allergic drugs and corticosteroids for rescue.
　　2. Serum sickness: Main symptoms include urticaria, fever, lymphadenopathy, local edema, occasionally proteinuria, vomiting, joint pain; injection site may show erythema, itching, and swelling. Usually occurs 7~14 days after injection, called delayed type. Also occurs 2~4 days after injection, called accelerated type. Symptomatic treatment for serum sickness can include calcium or antihistamines; generally recovers within several days to over ten days.
　　[Contraindications] Use with caution in individuals with positive allergy tests; see desensitization injection method for details.
　　[Precautions] |
　　1. This product is a liquid preparation. Do not use if the product is cloudy, has undispersed precipitate, foreign matter, or if the ampoule is cracked, label unclear, expired, or ineffective. Use the entire ampoule once opened.
　　2. Detailed records must be kept for each injection, including name, gender, age, address, number of injections, reactions after last injection, current allergy test results and post-injection reactions, manufacturer name and batch number of the antitoxin used.
　　3. Injection equipment and sites must be strictly disinfected. Syringes should be dedicated; if not, they must be thoroughly cleaned after use, preferably dry-heated or autoclaved. Syringes must be separate when injecting toxoid.
　　4. Special attention must be paid to preventing allergic reactions when using antitoxin. Allergy tests must be performed before injection and detailed allergy history inquired. Individuals or their immediate family members with a history of bronchial asthma, hay fever, eczema, or angioneurotic edema, or allergies to certain substances, or previous injections of equine serum preparations, must be especially cautious of allergic reactions.
　　(1) Allergy test: Dilute antitoxin 10 times with sodium chloride injection (0.1ml antitoxin plus 0.9ml sodium chloride injection), inject 0.05ml intradermally on the palmar side of the hand, observe for 30 minutes. No obvious reaction at injection site indicates negative, and antitoxin can be injected directly under close observation. If wheal enlargement, redness, infiltration, especially pseudopod-like or itching occurs, it is positive and desensitization injection must be used. If local reaction is severe or accompanied by systemic symptoms such as urticaria, nasal or throat itching, sneezing, it is strongly positive and antitoxin should be avoided. If necessary, desensitization injection should be used with rescue preparations ready. Even those without allergy history or negative allergy test may still have allergic shock. For caution, a small amount can be injected subcutaneously for testing, observe 30 minutes, if no abnormal reaction, then full dose can be injected subcutaneously or intramuscularly.
　　(2) Desensitization injection method: Generally, dilute antitoxin 10 times with sodium chloride injection, inject small amounts subcutaneously several times, observing 30 minutes after each injection. The first injection can be 0.2ml of 10-times diluted antitoxin; if no cyanosis, asthma, significant shortness of breath, or rapid pulse, inject 0.4ml for the second time; if still no reaction, inject 0.8ml for the third time; if still no reaction, the undiluted antitoxin in the ampoule can be injected subcutaneously or intramuscularly. For those with allergy history or strongly positive allergy test, the first injection dose and subsequent increments should be reduced and divided into multiple injections to avoid severe reactions.
　　5. Outpatients must be observed for 30 minutes after antitoxin injection before leaving.
　　[Storage] Storage: 2~8℃, protected from light and kept dry. Transportation: 2~8℃, protected from light and kept dry.
　　[Packaging] Ampoules, 10 vials/box.
　　[Validity Period] 36 months
　　[Execution Standard] "Pharmacopoeia of China" 2015 Edition, Volume III
　　[Approval Number] National Medicine Standard S10970021
　　[Manufacturer]
　　Company Name: Jiangxi Institute of Biological Products Co., Ltd.
　　Production Address: Jinggangshan Economic and Technological Development Zone, Ji'an City, Jiangxi Province
　　Postal Code: 343100
　　Phone Number: 0796-8403918
　　Fax Number: 0796-8403906
　　Website: http://www.jxswzp.cn/