Equip T
Revised: November 2015
AN: 01261/2014
SUMMARY OF PRODUCT CHARACTERISTICS
NAME OF THE VETERINARY MEDICINAL PRODUCT
Equip T
QUALITATIVE AND QUANTITATIVE COMPOSITION
Per dose of 2ml:
Active substances:
Immunopurified Tetanus Toxoid ≥ 30 IU/ml$
$ IU: International units
Adjuvant:
Aluminium phosphate
For a full list of excipients, see section 6.1.
PHARMACEUTICAL FORM
Suspension for injection.
CLINICAL PARTICULARS
Target species
Horses from 5 months of age
Indications for use, specifying the target species
For the active immunisation of horses of 5 months of age or older against tetanus to prevent mortality.
Duration of immunity is at least 36 months.
Onset of immunity is within 2 weeks of completion of the primary course.
Contraindications
None.
Special warnings
The efficacy of active immunisation of young foals against tetanus will be influenced by the level of maternally derived antibodies. This will vary between individuals due to a number of factors, e.g. the immune status of the dam; adequacy of colostral intake by the foal, etc. The vaccine should not be used in foals below 5 months of age, and foals should not be vaccinated until maternally derived antibodies have fallen below protective levels.
In any animal population, there may be a small number of individuals which fail to respond fully to vaccination. Successful vaccination depends on storage and administration of the vaccine and the ability of the animal to respond. This can be influenced by such factors as genetic constitution, intercurrent infection, age, nutritional status, concurrent drug therapy and stress.
Special precautions for use
Special precautions for use in animals
Do not use in unhealthy animals.
The product should be administered by respecting appropriate (aseptic) injection technique.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician.
Adverse reactions (frequency and seriousness)
Rarely (<1 in 1000) animals may exhibit a reaction to vaccination. This may be manifest by stiffness, a mild, transient rise in temperature, typically 9-12 hours post vaccination, or a small soft, non-painful local swelling (10-20 mm in diameter) at the injection site. These conditions normally resolve by the day following vaccination.
Injection site pain has been reported in very rare cases (<1 in 10, 000).
Occasional hypersensitivity reactions may occur. In the event of an allergic or anaphylactic reaction, immediate treatment should be given with a soluble glucocorticoid intravenously or adrenalin intramuscularly.
Use during pregnancy, lactation or lay
The vaccine may be used in pregnant mares which have been vaccinated against tetanus before pregnancy.
Heavily pregnant mares should not be subject to undue stress when vaccinated.
Interaction with other medicinal products and other forms of interaction
No information is available on the safety and efficacy of this vaccine when used with any other veterinary medicinal product. 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
Dose: 2 ml
Administration:Equip T should be shaken thoroughly before use and administered by deep intramuscular injection.
Primary vaccination
Two injections of 2 ml with an interval of 4-6 weeks between them.
Booster vaccination
One dose 36 months after the primary course, repeated at intervals of up to 36 months.
Overdose (symptoms, emergency procedures, antidotes), if necessary
Accidental overdosage is unlikely to cause any reactions other than those described in section 4.6.
Withdrawal period
Zero days
IMMUNOLOGICAL PROPERTIES
Equip T stimulates active immunity against tetanus.
ATCVet Code:QI05AB03
PHARMACEUTICAL PARTICULARS
List of excipients
Aluminium phosphate
Phosphate buffered saline
Incompatibilities
Do not mix with any other veterinary medicinal product.
Shelf life
Shelf-life of the veterinary medicinal product as packaged for sale: 3 years
Special precautions for storage
Store in a refrigerator (2°C to 8°C).
Protect from light. Do not freeze.
Keep the container in the outer carton.
Nature and composition of immediate packaging
Type I glass vial with chlorobutyl rubber stopper and aluminium overseal.
Packaging: box of 10 single-dose vials. Each box contains ten sterile
disposable 2 ml syringes and 10 sterile needles.
Type I glass syringe closed with bromobutyl rubber plunger
stopper and tip cap.
Packaging: Box of 10 single-dose prefilled syringes with needles
Not all pack sizes may be marketed.
Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products
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 HOLDER
Zoetis UK Limited
5th Floor, 6 St. Andrew Street
London
EC4A 3AE
MARKETING AUTHORISATION NUMBER
Vm42058/4064
DATE OF FIRST AUTHORISATION
17 October 2005
DATE OF REVISION OF THE TEXT
November 2015
Approved: 18 November 2015
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