Human Tetanus Immunoglobulin
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The instruction on antitetanic antibody application of human blood serum, a solution for intramuscular injection of 100 IU/ml
Before use please read attentively this instruction
Group name
The antibody antitetanic of human blood serum a solution for intramuscular injection represents the concentrated solution of the refined gamma globulins fraction extacted with a method of cold extraction by ethanol and subjected to process of an ultrafiltration, purification and virus purification at рН 4,0 and temperature 23-25 °С within 21 days.
Composition (on 1 ml)
Specific antitetanic antibodies 100 IU; the stabilizer glycine (glycocol) from 20 to 25 mg; sodium chloride 7 mg; water for injections. The preparation does not contain antibiotics. HBsAg, antibodies to a HIV-1, HIV-2 and to a hepatitis C virus are absent.
Description
A colorless or pale yellow clear or opalescent liquid
Indication
Human tetanus immunoglobulin is mainly indicated for the prophylaxis and treatment of tetanus, especially suitable for use in individuals hypersensitive to tetanus antitoxin (TAT).
Specifications
250 IU/vial (100 IU/ml, 2.5ml), 500 IU/vial (100 IU/ml, 5ml)
Dosage & administration
Administration: Human tetanus immunoglobulin is intended for intramuscular injection in the thigh. No skin test is necessary. It must not be administered intravenously.
Dosage:
- Prophylactic dose: The single prophylactic dose for adults or children is 250 IU. The dose may be doubled if the wound is severe or grossly contaminated.
- Reference therapeutic dose: 3000 to 6000 IU, which should be administered in divided doses at different sites.
Adverse reactions
In general, the adverse reactions are occurred rarely, though few people may experience swelling and pain, usually such symptoms are self-limited and require no special treatment.
Contraindications
Human tetanus immunoglobulin should not be administered to patients with known hypersensitivity to human immunoglobulin products.
Precautions
- Active immunization with Tetanus Vaccine, Adsorbed can be commenced at the same time when human tetanus immunoglobulin is used for passive immunization, but they should be administered in different injection sites, using separate syringes.
- Trace amount of sediment may appear during long-term storage but should disperse on shaking. It must not be used if the product contains any sediment or foreign matter that is not dispersible on shaking, or cracks appear on the vial, or the closure becomes loose, or the product is out of its shelf life.
- After the vial is opened, the full dose must be used immediately instead of in different times or in a second person.
- This is a blood product prepared from healthy human plasma, although the source plasma has been strictly screened, tested and viral inactivated in the manufacturing process, there is alight possibility that the final product may contain pathogenic factor(s) and may cause transmission of blood-borne diseases. The wide-spectrum protective antibodies available in human immunoglobulin can effectively protect patients from infection. Clinical experience has proved that, the human immunoglobulin administered intramuscularly is of good safety. It is advisable to keep the Batch No. and the records of this product after use.
- Do not freeze the product during transportation and storage.
- Human tetanus immunoglobulin should not be mixed with other pharmaceutical products.
- Administration of human tetanus immunoglobulin may, within three months after the administration, interfere with the active immune response of live attenuated vaccines, i.e., measles, parotitis and varicella.
Use in Pregnancy and Lactation
Animal reproduction studies have not been conducted with this product. It is also not known whether this product can affect reproduction capacity or cause fetal harm when administered to a pregnant woman. This product should be given to a pregnant woman only if clearly needed.
Pediatric Use
The safety and efficacy of this product in pediatric patients have not yet been established. When the use of this product becomes a must, please consult with a physician before use.
Geriatric Use
No special requirements are set for geriatric use. When the use of this product becomes a must, please consult with a physician before use.
Drug Interactions
Overdose
No reliable literature has ever reported the consequences caused by overdose of this product.
Pharmacology & Toxicology
Pharmacological action: This product contains high titers of tetanus antibodies able to neutralize the tetanus virus, and provide prophylaxis and treatment of infections caused by
Clostridium tetani
Toxicological studies: No reliable literature has ever reported that the human tetanus immunoglobulin can cause embryo-fetal toxicity or have toxic actions such as potential carcinogenicity and mutagenicity.
Pharmacokinetics
Literatures indicated that, human tetanus immunoglobulin enters the circulation of recipients 2 to 3 days after the intramuscular injection. Its half life is about 3 to 4 weeks, varying from patient to patient. IgG and its complexes are eliminated through the reticuloendothelial system.
Storage
Store and transport at 2-8℃. Protect from light.
Package Human tetanus immunoglobulin is available in single injection vials made of borosilicate glass tube and halogenated butyl rubber stopper, 1 vial/box.
Shelf life
24 months
Standard Executed
Volume III, CP2005
Approval Document No
| Specification | 250 IU/vial (100 IU/ml, 2.5ml) | 500 IU/vial (100 IU/ml, 5ml) |
|---|---|---|
| Approval Document No. | GYZZ S20043093 | GYZZ S20043094 |
For treatment-and-prophylactic institutes claims for quality of a preparation please direct to FGUN “SISQ of L.A.Tarasevich” (119002, Moscow, Sivtsev Vrazhek, 41, Tel. (495) 241-39-22, fax (495) 241-92-38)
