Hualan Biological Human Tetanus Immunoglobulin for those with anaphylaxis to tetanus antitoxin (TAT)

[Name of the Medicinal Product] 
Generic Name: Human Tetanus Immunoglobulin
[Composition]
Active ingredients: human tetanus immunoglobulin
Excipients: glucose, Tween-80, NaCl, glycine, WFI
[Characters] 
It is a clear, colorless or light yellow liquid. Opalescence may occur but without turbidity. 
[Indications] 
The product is used for prevention from tetanus and treatment of it, especially indicated for those with anaphylaxis to tetanus antitoxin (TAT).
[Strengths]
250 IU per container (2.5 ml): each container containing 250 IU of tetanus antibody potency, filling quantity of 2.5 ml. 
[Administration and Dosage]
Administration: inject intradermally at the buttock; skin test is not required. 
Dosage: 1. Prevention dose: each single human dose of 250 IU for both children and adults. Double the dose for those with more serious wounds or more seriously polluted wounds. 
2. Reference therapeutic dose: 3000～6000 IU, which should be used up as soon as possible. Injection at different sites is allowable. Follow the direction of the physician.
[Adverse Reactions]
Generally no adverse reactions occur after injection. Erythema and swelling or pain in the site of injection may appear in a few people. Normally no treatment is necessary, for it could be relieved spontaneously.
[Contraindications]
Those with a history of hypersensitivity to human immunoglobulin products. 
[Warnings and Precautions] 
1. The Tetanus Vaccine, Adsorbed may be used for active immunization while the product is used for passive immunization, but at different sites of injection with different equipment. 
2. It is a clear, opalescent liquid, and the precipitate which can be dispersed on shaking is allowable. Do not use the product if any clumps not dispersed on shaking, foreign matters, or any leakage of container, expired shelf life are found. 
3. Once the container is opened, the product shall be used up at one time. Divided dosing is prohibited.
4. Intravenous injection is strictly contraindicated. 
[Pregnancy and Nursing Mothers]
Pregnant and nursing women shall use with caution, and should consult the physician if the product is clearly needed. 
[Pediatric Use] 
See [Administration and Dosage]
[Geriatric Use]
Study on this monograph has not been conducted with this product, and there are not systematic and reliable references either.
[Drug Interactions]
The product should be used exclusively. 
[Overdosage]
Allergic reactions or pain in the injection site may occur. 
[Pharmacology & Toxicology]
Containing high potency of tetanus antibody, the product will specifically neutralize the tetanus toxin to prevent and treat the clostridium tetani infection.
[Pharmacokinetics] 
After injection of the product, the tetanus antibody will be released from the injection site to the blood cycle system, and will achieve a maximal plasma-drug concentration in 2～4 days. The biological half life of human tetanus immunoglobulin is 3～4 weeks, then the lgG or lgG complex will be eliminated by the immune system. 
[Storage] Store and ship at 2-30°C, protected from light. 
[Packaging] Borosilicate glass vial, sealed with bromobutyl rubber stopper, packaging of 1 vial per carton. 
[Shelf Life] 36 months starting from the date of production. 
[Product Standard] Chinese Pharmacopeia Volume III (2010)
[National Drug Approval Number] GYZZ S20023036
[Manufacturer]
Name: Hualan Biological Engineering Inc.                                 

Tel: 86-373-3559991
Address: Jia No.1, Hualan Ave., Xinxiang, Henan, China  

Fax: 86-373-3559911
Website: www.hualanbio.com                                           Zip code: 453003