Instructions for Tetanus Antitoxin (Ampoule)
Warning: Use with caution for those with positive allergic reactions. For details, see desensitization injection method
[Drug Name]
Common name: Tetanus Antitoxin
English name: Tetanus Antitoxin
Hanyu Pinyin: Poshangfeng Kangdusu
[Ingredients]
The main ingredient of this product is equine tetanus immunoglobulin digested by gastric enzymes.
This product is a liquid antitoxin globulin preparation made from plasma obtained from horses immunized with tetanus toxoid, which is purified after digestion with pepsin.
Excipient: Sodium chloride.
[Characteristics]
This product is a clear liquid that is colorless or light yellow in color. A small amount of precipitate that can be shaken off may precipitate out after prolonged storage.
[Indications]
Used for the prevention of tetanus. In case of tetanus or suspicious symptoms, antidote treatment should be administered promptly while surgical treatment and other therapies are being carried out.
[Specification] 0.75ml, 1500IU/vial.
[Usage and Dosage]
Usage: Subcutaneous injection should be administered at the attachment site of the deltoid muscle in the upper arm. Intramuscular injection should be administered at the middle part of the deltoid muscle in the upper arm or the upper outer part of the gluteus maximus muscle. When injecting toxoid simultaneously, the injection sites must be separated.
Dosage: Subcutaneous or intramuscular injection of 1500~3000IU once, with the same dosage for children and adults; for severely injured individuals, the dosage can be increased by 1~2 times. After 5~6 days, if the risk of tetanus infection has not been eliminated, repeat the injection.
[Adverse Reactions]
1. Anaphylactic shock: It can occur suddenly during or within minutes to tens of minutes after injection. Patients may suddenly exhibit symptoms such as depression or irritability, pale or flushed face, chest tightness or asthma, cold sweat, nausea or abdominal pain, rapid and weak pulse, decreased blood pressure, and in severe cases, coma and collapse. If not rescued in time, they can quickly die. In mild cases, injection of adrenaline can alleviate symptoms; in severe cases, intravenous infusion and oxygen therapy are required, with vasopressors to maintain blood pressure, and anti-allergic drugs and corticosteroids used for rescue.
2. Serum sickness: The main symptoms include urticaria, fever, lymphadenopathy, localized edema, occasional proteinuria, vomiting, and joint pain. Erythema, itching, and edema may occur at the injection site. The disease generally manifests 7 to 14 days after injection, known as the delayed type. There is also an accelerated type that manifests 2 to 4 days after injection. Symptomatic treatment for serum sickness can be administered with calcium supplements or antihistamines, and recovery typically takes several days to ten days.
[Taboo]
People with positive allergic reactions in allergy tests should use with caution. For details, see desensitization injection method.
[Precautions]
1. This product is a liquid product. If the product is turbid, has insoluble sediment or foreign matter, the ampoule has cracks, the label is unclear, or it has expired, it cannot be used. The ampoule should be used up at once after opening.
2. Detailed records must be kept for each injection, including name, gender, age, address, number of injections, reaction after the last injection, result of this allergy test, reaction after injection, name of the production unit of the antitoxin used, batch number, etc.
3. Injection equipment and injection sites should be strictly sterilized. Syringes should be dedicated, and if not, they should be thoroughly cleaned and processed after use. It is best to sterilize them by dry heat or autoclaving. When injecting toxoids, syringes must be separated.
4. Special attention must be paid to prevent allergic reactions when using antitoxins. Before injection, an allergy test must be conducted and previous allergic history must be inquired in detail. Anyone who has a history of bronchial asthma, hay fever, eczema, or angioneurotic edema, or is allergic to certain substances, or has previously received injections of horse serum preparations, must be particularly vigilant against the occurrence of allergic reactions.
(1) Allergy test: Dilute the antitoxin 10 times with sodium chloride injection (0.1ml antitoxin plus 0.9ml sodium chloride injection), inject 0.05ml intradermally into the anterior palm, and observe for 30 minutes. If there is no obvious reaction at the injection site, it is considered negative, and the antitoxin can be directly injected under close observation. If the injection site shows an increase in skin rash, redness, swelling, especially those resembling pseudopodia or accompanied by itching, it is a positive reaction, and desensitization injection must be used. If the local reaction is particularly severe or accompanied by systemic symptoms such as urticaria, itching or sneezing of the nasopharynx, it is a strong positive reaction, and the use of antitoxin should be avoided. If it must be used, desensitization injection should be adopted, and preparations for rescue should be made. In case of anaphylactic shock, immediate rescue should be carried out. Even for those without a history of allergy or negative allergic reactions, the possibility of anaphylactic shock cannot be ruled out. For prudence, a small amount can be injected subcutaneously for testing first, and if there is no abnormal reaction, the full amount can be injected subcutaneously or intramuscularly.
(2) Desensitization injection method: Under normal circumstances, the antitoxin can be diluted 10 times with sodium chloride injection solution and injected subcutaneously in small amounts several times, with an observation period of 30 minutes after each injection. For the first injection, 0.2ml of the 10-fold diluted antitoxin can be administered. If there is no observation of cyanosis, wheezing, or significant shortness of breath, or accelerated pulse rate, a second injection of 0.4ml can be given. If there is still no reaction, a third injection of 0.8ml can be administered. If there is still no reaction, the entire undiluted antitoxin in the ampoule can be injected subcutaneously or intramuscularly. For individuals with a history of allergy or a strongly positive allergy test result, the dosage for the first injection and subsequent increments should be appropriately reduced, and multiple injections should be given to avoid severe reactions.
5. Outpatients must be observed for 30 minutes after receiving an antitoxin injection before they are allowed to leave.
[Medication for pregnant and lactating women] Not clear yet.
[Children's medication] Not clear yet.
[Medication for the elderly] Not clear yet.
[Drug Interactions] Not clear yet.
[Drug overdose] Not clear yet.
[Pharmacology and Toxicology] This product contains specific antibodies and has the effect of neutralizing tetanus toxin, making it suitable for the prevention of Clostridium tetani infection. The toxicological effects are not yet clear.
[Pharmacokinetics] is not yet clear.
[Storage]
Storage: Store in the dark at 2~8℃.
Transportation: Store in the dark at 2~8℃.
[Packaging] Low borosilicate glass ampoules, 10 pieces/box.
[Expiration Date] 36 months
[Executive Standard] Chinese Pharmacopoeia 2025 Edition Volume 3 and Drug Registration Standard YBS00102025
[Approval Number] National Medical Product Approval Number S10970021
[Marketing Authorization Holder] Jiangxi Institute of Biological Products Co., Ltd
[Manufacturer] Jiangxi Institute of Biological Products Co., Ltd
Address: Jinggangshan Economic and Technological Development Zone, Ji'an City, Jiangxi Province
Postal code: 343100
Phone number: 0796-8403918
Fax number: 0796-8403906
Drug vigilance hotline: 0796-8403108
Website: http://www.jxswzp.cn