Tetanus Antitoxin Behring 50ml.
Target species
Horse, sheep and dog.
Indications for use
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.
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.
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 intravenous or intramuscular injection to 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.
Contra-indications
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.
Special warnings for each target species
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 (1 ml Tetanus Antitoxin Behring, subcutaneous, 30 - 40 minutes observation) should be performed.
Special precautions for use
None.
Adverse reactions
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 (see Section "Special warnings for each target species").
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 IU, 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.
Use during pregnancy, lactation or lay
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 in section "Adverse reactions".
Interactions
Safety and efficacy data are available which demonstrate that this vaccine can be administered on the same day but not mixed with Equilis Te and Equilis Prequenza Te (for proper use, refer to the package leaflets). No information is available on the safety and efficacy of this vaccine when used with any other veterinary medicinal product except the products mentioned above. A decision to use this vaccine before or after any other veterinary medicinal product therefore needs to be made on a case by case basis.
Amounts to be administered and administration route
I. Dosage and method of administration in horses
| Horse | 7,500 - 10,000 IU = 7.5 - 10 ml |
| Foal with body weight up to 100 kg | 3,000 IU = 3.0 ml |
| Horse | 20,000 - 50,000 IU = 20 - 50 ml |
| Foal with body weight up to 100 kg | 30,000 IU = 30 ml |
Method of administration: Subcutaneous (s.c.) application.
The dosage for pre-operation treatment or after injury should contain:
Sheep (s.c.)
3,000 IU = 3.0 ml
Lamb (s.c.)
1,500 IU. = 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 IU
= 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 IU
= 10 - 20 ml
2
Do not administer more than the dose indicated to horses or dogs. In sheep the administration of an overdose of 6 ml/6,000 IU may result in an increase in body temperature of up to 2 ºC and local reactions, but no ulceration or abscess formation should be observed.
Withdrawal periods
Zero days.
1 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 (see also section "Adverse reactions"). Dosage:
2
Pharmacological particulars
Immunological properties
To provide passive immunity against tetanus infection.
ATC-vet code: QI04AM02, QI05AM01, QI07AM
Pharmaceutical particulars
Excipients
Phenol and salts.
Major incompatibilities
Do not mix with any other veterinary medicinal product.
Shelf life
Shelf life of the veterinary medicinal product as packaged for sale: 42 months.
Shelf life after first opening of the immediate packaging: Broached multidose containers should be used within one working day (10 hours) and kept stored at 2 ºC - 8 ºC.
Special precautions for storage
Store at 2 ºC - 8 ºC. Protect from light. Do not freeze.
Immediate packaging
Cardboard box with one injection bottles made of moulded glass of glass type I according to Ph.Eur. sealed with a chlorobutyl rubber stopper of rubber type I according to Ph.Eur. and an aluminium crimp cap.
Disposal
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.
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