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Date: Saturday, May 4, 2024 14:39

Description: MSD-AH
Release 2.117
Equilis® Te suspension for injection for horses
 
Species: Horses and other equidae
Therapeutic indication: Immunological veterinary medical products: For horses
Active ingredient: Vaccine Antigens
Product:Equilis® Te suspension for injection for horses
Product index: Equilis® Te
Withdrawal notes: Horses: Zero days
Incorporating:
Qualitative and quantitative composition
Each dose of 1 ml contains:
Active substance:
Tetanus toxoid: 40 Lf 1
1 Flocculation equivalents; corresponds with ≥ 30 IU/ml guinea pig serum in the Ph. Eur. potency test.
 
Adjuvants:
Purified Saponin: 375 µg
Cholesterol: 125 µg
Phosphatidylcholine: 62.5 µg
 
For the full list of excipients, see section "Pharmaceutical particulars".
Pharmaceutical form
Suspension for injection.
Clear opalescent suspension.
Clinical particulars
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
2 years after the first revaccination
Contraindications
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
Vaccinate healthy animals only.
Operator warning
In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician.
Special precautions for the protection of the environment
Not applicable.
Adverse reactions
Horses:
Rare
(1 to 10 animals /10,000 animals treated):
Injection site swelling1, Injection site pain2.
Very rare
(<1 animal / 10,000 animals treated, including isolated reports):
Fever3, Lethargy3, Inappetence3, Hypersensitivity reaction4.
1 A diffuse hard or soft swelling (max. diameter 5 cm), regressing within 2 days. A local reaction exceeding 5 cm and possibly persisting longer than 2 days may occur in very rare cases.
2 Pain at the injection site may result in temporary functional discomfort (stiffness).
3 Fever, sometimes accompanied by lethargy and inappetence, may occur for 1 day, and up to 3 days in exceptional circumstances.
4 Including anaphylaxis (sometimes fatal). If such a reaction occurs, appropriate treatment should be administered without delay.
Reporting adverse events is important. It allows continuous safety monitoring of a veterinary medicinal product. Reports should be sent, preferably via a veterinarian, to either the marketing authorisation holder or the national competent authority via the national reporting system. See also the package leaflet for contact details.
Use during pregnancy or lactation
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 Serum from MSD Animal Health (see section Amounts to be administered and administration route).
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.
Allow the vaccine to reach room temperature before 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).
V1
V2
5
12
V3
24
V4
0
1
6
18
42 months
Equilis Te
Equilis Te
Equilis Te
Equilis Te
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
ATCvet code: QI05AB03
Pharmacotherapeutic group
Inactivated bacterial vaccine.
To stimulate active immunity against tetanus.
Pharmaceutical particulars
Excipients
Lactose
Phosphate buffer
Chloride buffer
Traces of formaldehyde
Purified Saponin
Cholesterol
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
Medicines should not be disposed of via wastewater.
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements.
Marketing Authorisation Holder (if different from distributor)
Marketing Authorisation Number
UK(GB): Vm 01708/5034
Significant changes
Date of the first authorisation or date of renewal
08 July 2005.
Date of revision of the text
UK(GB): November 2023
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:Equilis Te 10x1ds:
GTIN:08713184096418