Equilis Te, Suspension for Injection, for Horses

Nchi: Uingereza

Lugha: Kiingereza

Chanzo: VMD (Veterinary Medicines Directorate)

Viambatanisho vya kazi:

Clostridium tetani

Inapatikana kutoka:

MSD Animal Health UK Limited

ATC kanuni:

QI05AB03

INN (Jina la Kimataifa):

Clostridium tetani

Dawa fomu:

Suspension for injection

Dawa ya aina:

POM-V - Prescription Only Medicine – Veterinarian

Kundi la matibabu:

Horses

Eneo la matibabu:

Inactivated Bacterial Vaccine

Idhini hali ya:

Authorized

Idhini ya tarehe:

2005-07-08

Tabia za bidhaa

Revised: November 2023
AN: 03430/2022
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Equilis Te suspension for injection for horses
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each dose (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:
Iscom Matrix containing:
Purified Saponin
375 µg
Cholesterol
125 µg
Phosphatidylcholine
62.5 µg
For the full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Suspension for injection.
Clear opalescent suspension.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Horses
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
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.
4.3
CONTRAINDICATIONS
None.
Revised: November 2023
AN: 03430/2022
Page 2 of 6
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
Vaccinate healthy animals only.
4.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals:
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 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.
Special precautions for the protection of the environment:
Not applicable.
4.6
ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS)
Horses:
Rare
(1 to 10 animals / 10,000 animals
treated):
Injection site swelling
1
, Injection site
pain
2
.
Very rare
(<1 animal / 10,000 animals treated,
including isolated reports):
Fever
3
, Lethargy
3
, Inappetence
3
,
Hypersensitivity reactio