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Date: Saturday, December 4, 2021 6:54

Description: MSD-AH
Telephone: 01908 685685 (Customer Support Centre)
Release 3.27
Tetanus Antitoxin Behring
 
Species: Horses and other equidae, Sheep, Dogs
Therapeutic indication: Immunological veterinary medical products: For sheep, For horses, For dogs
Active ingredient: Vaccine Antigens
Product:Tetanus Antitoxin Behring
Product index: Tetanus Antitoxin Behring
Sheep - meat: Zero days
Withdrawal notes: Horse meat: Zero days
Qualitative and quantitative composition
Active Constituents per 1 ml
protein from horses: max. 170 mg
with antibodies against tetanus: 1000 IU
 
Excipient
Phenol min. 3.7 mg and max. 5.0 mg.
 
For the full list of excipients, see section " Pharmaceutical Particulars".
Pharmaceutical form
Tetanus Antitoxin Behring is a purified antiserum derived from horses, presented as a clear antitoxin solution.
Clinical particulars
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 or lactation
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
I.a Prophylaxis:
Method of administration:
Subcutaneous or intramuscular application.
Dosage for pre-operation treatment or after injury:
Horse
7,500 - 10,000 IU =
7.5 - 10 ml
Foal with body weight up to 100 kg
3,000 IU = 3.0 ml
If the operation wound or the injury has not improved after 10-14 days the serum application has to be repeated (see section "Special warnings for each target species").
Simultaneous with vaccination
Application: subcutaneously or intramuscularly.
Tetanus Antitoxin Behring and vaccines* against tetanus are to be applied at different parts of the body. Dosage see 'prophylaxis'.
* Equilis Prequenza Te and Equilis Te. For proper use please refer to the relevant product leaflets.1I.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:
Horse
20,000 - 50,000 IU
= 20 - 50 ml
Foal with body weight up to 100 kg
30,000 IU = 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 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
Overdose
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.
Marketing Authorisation Number
UK: Vm 01708/4506
Significant changes
Date of the first authorisation or date of renewal
14 October 2005
Date of revision of the text
June 2021
Any other information
For animal treatment only. Keep out of the sight and reach of children.
Legal category
Legal category: POM-V
GTIN
GTIN description:Tetanus Antitoxin 1x50ml:
GTIN:8713184027122