Antitet 1500 IU/Antitet 3000 IU/Antitet 5000 IU

Antitet 1500 IU/Antitet 3000 IU/Antitet 5000 IU

Manufacturer:

Sinochem Ningbo

Distributor:

2 World Traders
Full Prescribing Info
Contents
Tetanus antitoxin.
Description
Each ampoule contains: Tetanus Antitoxin 1500 IU/0.7 mL, 3000 IU/0.95 mL or 5000 IU/2 mL.
Tetanus Antitoxin is prepared from immunized plasma of healthy horses through the process of ammonium sulfate fractionation and ultra filtration after being digested with pepsin. It provides temporary passive immunity against tetanus.
The term antisera includes antitoxins which are antibodies that combine with and neutralize specific toxins, and antivenins which are antitoxins directed against toxic venom of poisonous animals.
Indications/Uses
For those with tetanus symptoms, Tetanus Antitoxin should be given immediately together with surgical and other clinical remedies.
For deep open wounds and those in danger of being infected, prophylactic injection of Tetanus Antitoxin should be given at once. Patients who have had previous injection of Tetanus Toxoid should be given one or more injection of Tetanus Toxoid (but not tetanus antitoxin). To those who have not had previous Tetanus Toxoid injection or without a clear history of immunization, both antitoxins should be given for prophylaxis and permanent immunity.
The right site for subcutaneous injection of the Tetanus Antitoxin is around the deltoid muscle of the upper arm. If Tetanus Toxoid is to be given at the same time separate sites are desirable. The right site for intramuscular injection is the center area of the deltoid muscle or the lateral upper part of the gluteus maximum.
Intravenous route should be used until no untoward reaction occurs after intramuscular or subcutaneous injection. Intravenous injection should be done slowly: not more than 1 mL/min and must not exceed 4 mL/min afterwards.
The total volume for a single dose should be not more than 40 mL for adults and not more than 0.8 mL/kg body weight for children. Tetanus Antitoxin may be diluted with dextrose solution or physiological saline for intravenous drip. The drip must be stopped at once if any untoward reaction occurs.
Dosage/Direction for Use
Prophylactic Use: 1500 I.U.-5000 I.U.: For adults and children, injection should be repeated after six days when contamination still persists.
For those who have been immunized previously with Tetanus Toxoid, it is advisable to give a booster dose of Tetanus Toxoid only.
Tetanus Antitoxin may be given by Subcutaneous (SC), Intravenous (IV) or Intramuscular (IM) route.
Contraindications
Do not use for patients sensitive to Tetanus Antitoxin.
Not recommended for pregnant women.
Special Precautions
Before using, the ampoule package must be examined with care. Any broken ampoules containing precipitates or particles must be discarded.
Before injecting the antiserum, information should be obtained whenever possible as to whether previous injections of antiserum have been received and whether the patient is subject to hypersensitivity disorders.
Sensitivity testing should be performed before the administration of antisera. The patient must be kept under observation after the administration of doses of antisera. Adrenaline injection and resuscitation facilities should be available.
Sensitivity test should be done. Dilute the Antitoxin 1:10 with physiological saline (i.e. 0.1 mL antitoxin + 0.9 mL saline) and inject 0.05 mL of the diluted antitoxin intracutaneously on the flexor surface of the forearm. A positive reaction characterized by erythema, edema or infiltration appearing in 15-30 minutes denotes sensitivity to horse serum preparation. A negative reaction may be treated in the usual manner, a positive reaction must be desensitized when antitoxin administration is available.
The following desensitization procedure may be recommended: dilute the antitoxin 1:10 with sterile physiological saline. Inject subcutaneously 0.2 mL at first, observe for 30 minutes. If no reaction occurs, give another injection with higher dose. If no reaction occurs, give the third injection and so forth. If there still no reaction, then the administration of undiluted antitoxin can be started.
Adrenaline should always be at hand. In case of anaphylaxis, adrenaline should be given at once. All patients who developed hypersensitive reactions following injection should be handled properly.
Adverse Reactions
Type 1 hypersensitivity reaction: Anaphylaxis shock may suddenly occur during or after the injection of equine antitoxin with symptoms of gloominess or dysphoria, pale or flush face, chest depression or asthma, cold sweat, nausea or abdominal pain, weak and rapid pulses, hypertension in severe cases.
Serum Sickness (Type III hypersensitivity reaction) may occur frequently, 7 to 10 days after the injection. The main symptoms are urticaria, high fever, lymphadenopathy, local swelling and occasionally albuminuria, vomiting, joint pain as well as erythema, itchiness and edema at the vaccination site.
Reporting of Suspected Adverse Reactions: To allow continued monitoring of the benefit/risk balance of the medicinal product reporting of suspected adverse reactions is necessary. Healthcare professional are encouraged to report any suspected adverse reactions directly to the imported, distributor and/or report to FDA.
Patients are advised to seek immediate medical attention at the first signs of adverse reactions.
Storage
Store at 2-8°C. Do not freeze.
ATC Classification
J06AA02 - tetanus antitoxin ; Belongs to the class of immune sera. Used in the treatment of acute infectious diseases caused by toxigenic strains.
Presentation/Packing
Inj (amp) 1,500 IU/0.7 mL x 10's. 3,000 IU/0.95 mL x 10's. 5,000 IU/2 mL x 10's.
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