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Equilis Te (pack of 10)

Item Number: EQUILISTE

Equilis Te (pack of 10)

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Description

Equilis Te (pack of 10).

Target species:
Horses

Indications for use:
Active immunisation of horses from 6 months of age against tetanus to prevent mortality.

Onset of immunity: 2 weeks after the primary vaccination course.

Duration of immunity: 17 months after the primary vaccination course, 24 months after the first revaccination.

Contra-indications:
None.

Special warnings for each target species:
Foals should not be vaccinated before the age of 6 months, especially when born to mares that were revaccinated in the last two months of gestation, because of possible interference by maternally derived antibodies

Special precautions for use:
Only healthy animals should be vaccinated.

Operator warning:
In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician.

Adverse reactions:
A diffuse hard or soft swelling (max. diameter 5 cm) may rarely occur at the injection site, regressing within 2 days. In very rare cases a local reaction exceeding 5 cm and possibly persisting longer than 2 days may occur. Pain at the injection site can occur in rare cases which may result in temporary functional discomfort (stiffness). In very rare cases, fever, sometimes accompanied by lethargy and inappetence, may occur for 1 day, and up to 3 days in exceptional circumstances. 

The frequency of adverse reactions is defined using the following convention:

-very common (more than 1 in 10 animals displaying adverse reaction(s) during the course of one treatment)

-common (more than 1 but less than 10 animals in 100 animals)

-uncommon (more than 1 but less than 10 animals in 1,000 animals)

-rare (more than 1 but less than 10 animals in 10,000 animals)

-very rare (less than 1 animal in 10,000 animals, including isolated reports).

Use during pregnancy, lactation or lay:
Can be used during pregnancy and lactation.

Interactions:
Safety and efficacy data are available which demonstrate that this vaccine can be administered on the same day but not mixed with Tetanus Antitoxin Behring.

No information is available on the safety and efficacy of this vaccine when used with any other veterinary medicinal product except the product 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:
Intramuscular use.

Vaccination schedule: Primary vaccination course Administer one dose (1ml), by intramuscular injection, according to the following schedule:

Primary vaccination course: first injection from 6 months of age, second injection 4 weeks later.

Revaccination:The first revaccination is given not later than 17 months after the primary vaccination course. Thereafter a maximum interval of two years is recommended (see schedule).

Equilis Te datasheet (revised Nov 2011)

In case of increased infection risk or insufficient colostrum intake, an additional initial injection can be given at the age of 4 months followed by the full vaccination programme (primary vaccination course at 6 months of age and 4 weeks later)

Concurrent active and passive immunisation (emergency vaccination):
The vaccine can be used together with Tetanus Antitoxin Behring for treatment of injured horses that have not been immunised against tetanus. In that case, the first dose (V1) of vaccine can be given concurrently with the appropriate prophylactic dose of Tetanus Antitoxin Behring at a separate injection site, using separate syringes and needles. This will lead to a passive protection against tetanus for at least 21 days after concurrent administration. The second dose of the vaccine (V2) should be administered 4 weeks later. A third vaccination with Equilis Te should be repeated at least four weeks later. Concurrent use of Equilis Te and Tetanus Antitoxin Behring may reduce active immunity against tetanus compared to horses vaccinated with Equilis Te in the absence of tetanus antitoxin serum. 

Overdose:
Following the administration of a double dose of vaccine, no side effects other than those described under section "Adverse reactions" have been observed except for some depression at the day of vaccination.

Withdrawal periods:
Zero days.

Pharmacological particulars:

Immunological properties:
Pharmacotherapeutic group: Inactivated bacterial vaccine.

ATC vet code: QI05AB03

To stimulate active immunity against tetanus.

Pharmaceutical particulars:

Excipients:
Lactose, Phosphate buffer, Chloride buffer, Traces of formaldehyde, Purified Saponin, Cholesterol and Phosphatidylcholine.

Major incompatibilities:
Do not mix with any other veterinary medicinal product.

Shelf life:
Shelf life of the veterinary medicinal product as packaged for sale: 2 years.

Special precautions for storage:
Store in a refrigerator (2 °C – 8 °C). Protect from light.

Do not freeze.

Immediate packaging:
1 ml suspension in type I glass vial closed with a halogenobutyl rubber stopper and sealed with an aluminium cap.

1 ml suspension in type I glass pre-filled syringe, containing a plunger with a halogenobutyl end and closed with a halogenobutyl stopper.

Package size:
Cardboard box with 10 glass vials.

Cardboard box with 10 pre-filled syringes with needles.

Not all pack sizes may be marketed.

Disposal.

Data Sheets

EQUILISTE: Data Sheet

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