Company
Tetanus Antitoxin Behring Data Sheet
Solution for injection for horses, sheep and dogs.Presentation
Tetanus Antitoxin Behring is a purified antiserum derived from horses, presented as a clear antitoxin solution containing per 1 ml max. 170 mg protein from horses with 1000 I.U. antibodies against tetanus. Phenol £5.0 mg is added as a preservative.
Uses
Tetanus Antitoxin Behring is intended for prophylactic use in horses, sheep and dogs to reduce the risk of tetanus infection, as a result of accidental injury or as a preoperative precaution.
Tetanus Antitoxin Behring is intended for therapeutic use in horses and dogs to enhance recovery rates in animals showing clinical signs of tetanus, when combined with other treatments.
After subcutaneous and intramuscular injection of Tetanus Antitoxin Behring, maximum serological titres can be expected approximately 2 days after administration. The titres slowly decrease with time, but the protective effect lasts for between 2 and 3 weeks.
After intravenous or intramuscular injection in horses, serological titres associated with protection can be reached within one to four hours.
After subarachnoidal injection, effective titres in the central nervous system are reached straight after application. The duration of effective antibody titres has not been investigated in the central nervous system. The intravenous and subarachnoidal application routes are recommended for therapeutic use of Tetanus Antitoxin Behring in horses only.
Dosage and administration
I. Dosage and method of administration in horses
I.a Prophylaxis:
Method of administration: Subcutaneous or intramuscular application.
Dosage for pre-operation treatment or after injury:
Horse | 7,500 - 10,000 I.U. = 7.5 - 10 ml |
Foal with body weight up to 100 kg | 3,000 I.U. = 3.0 ml |
If the operation wound or the injury has not improved after 10-14 days the serum application has to be repeated.
Simultaneous with vaccination
Method of administration: subcutaneously or intramuscularly.
Tetanus Antitoxin Behring and vaccines* against tetanus are to be applied at different parts of the body. Dosage see 'Prophylaxis' above.
I.b Therapeutic:
Method of administration: Application preferably intravenously, otherwise subcutaneously or intramuscularly.
To supply the central nervous system with antitoxin the administration of Tetanus Antitoxin Behring into the subarachnoid space is recommended.
Dosage:
Horse | 20,000 - 50,000 I.U. = 20 – 50 ml |
Foal with body weight up to 100 kg | 30,000 I.U. = 30 ml |
The given doses should be applied in an as early as possible stage of the disease. A repeated administration on the two following days can be useful.
II. Dosage and method of administration in sheep
Method of administration: Subcutaneous (s.c.) application.
The dosage for pre-operation treatment or after injury should contain:
Sheep (s.c.) | 3,000 I.U. = 3.0 ml |
Lamb (s.c.) | 1,500 I.U. = 1.5 ml |
III. Dosage and method of administration in dogs
Method of administration: Subcutaneous (s.c.) or intramuscular (i.m.) application.
a. The dosage for pre-operation treatment or after injury should contain:
Dog (i.m.) depending on the body weight (80 I.U./kg) | Min 500 – max 2,500 I.U. = 0.5 – 2.5 ml |
b. The therapeutic dosage should contain:
Dog (i.m.) depending on the body weight (1000 I.U./kg) | Min 10,000 – max 20,000 I.U. = 10 – 20 ml |
Contra-indications, warnings, etc.
Administration to cats is contra-indicated. Cats are unable to metabolise the preservative phenol as rapidly as other species due to the absence of a specific enzyme.
A transient local swelling may occur after vaccination. A transient rise in body temperature may occasionally occur on the day of application and the day after. In very rare cases, especially after repeated administration, hypersensitivity reactions may occur. Especially heterologous animals are susceptible.
It has been concluded from studies that the product is unlikely to exacerbate the disease when it is administered to horses affected with clinical tetanus, with doses of 20,000 to 50,000 I.U., administered by the intramuscular, subcutaneous or intravenous routes, if necessary repeated at intervals over the space of a few days, or by injection into the subarachnoid space.
Do not administer more than the dose indicated to horses or dogs. In sheep, the administration of an overdose of 6 ml/6,000 I.U. may result in an increase in body temperature of up to 2ºC and local reactions, but no ulceration or abscess formation should be observed.
After repeated administration at longer intervals, sensitisation may occur leading to hypersensitivity reactions/anaphylactic shock.
Administering repeat doses at longer intervals is therefore not recommended.
Especially if a (repeated) intravenous application is intended in heterologous animals a biological pre-testing (1ml Tetanus Antitoxin Behring s.c., 30-40 minutes observation) should be performed.
The safe use of Tetanus Antitoxin Behring during pregnancy and lactation has not specifically been assessed. However, with regard to use in horses, on the basis of experience from field use in mares and from published data employing the administration of a different tetanus hyperimmune serum in pregnant mares it is concluded that it is unlikely to cause any reaction other than that described above.
No information is available on the safe and efficacious concurrent use of Tetanus Antitoxin Behring with any other immunological product except for the following vaccines; Equilis Te and Equilis Prequenza Te, when these products are marketed. Refer to the product leaflets for proper use of these products.
Do not mix with any other medicinal product.
Field experience suggests that, for horses that have not been vaccinated or are not completely immunised against tetanus, administration of the Tetanus Toxoid Concentrated vaccine with Tetanus Antitoxin Behring at the same time at a separate site, may be safe (for proper use refer to the product leaflet). It is therefore recommended that no other vaccines than these should be administered within 14 days before or after administration of the product.
Withdrawal period:
Zero days
For animal treatment only. Keep out of reach AND SIGHT of children.
Pharmaceutical precautions
Store between +2ºC and +8ºC. Protect from light. Do not freeze.
Broached multidose containers should be used within one working day (10 hours) and kept stored at +2ºC to +8ºC.
Disposal advice:
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.
Legal category
POM-V To be supplied only on veterinary prescription.
Package quantities
50 ml injection bottles made of moulded glass of glass type II according to Ph.Eur. sealed with a chlorobutyl rubber stopper of rubber type I according to Ph.Eur. and an aluminium crimp cap.
Further information
Nil.
Marketing Authorisation number
Vm 01708/4506 UK authorised veterinary medicinal product.
Marketing Authorisation holder
Intervet UK Ltd.
Walton Manor
Walton
Milton Keynes
Bucks. MK7 7AJ
Distributed in Northern Ireland by:
Intervet Ireland Ltd.
Magna Drive
Magna Business Park
Citywest Road
Dublin 24
Date of text preparation
31/08/06
* Tetanus Toxoid Concentrated, Equilis Prequenza Te and Equilis Te. For proper use please refer to the relevant product leaflets.