Equilis Te
Страна: Европейски съюз
Език: английски
Източник: EMA (European Medicines Agency)
Листовка
(PIL)
30-04-2020
Данни за продукта
(SPC)
30-04-2020
Доклад обществена оценка
(PAR)
15-02-2021
Активна съставка:
tetanus toxoid
Предлага се от:
Intervet International BV
АТС код:
QI05AB03
INN (Международно Name):
Adjuvanted vaccine against tetanus
Терапевтична група:
Horses
Терапевтична област:
Immunologicals for equidae
Терапевтични показания:
Active immunisation of horses from 6 months of age against tetanus to prevent mortality.Onset of immunity: 2 weeks after the primary vaccination courseDuration of immunity: 17 months after the primary vaccination course, 24 months after the first revaccination
Каталог на резюме:
Revision: 8
Статус Оторизация:
Authorised
Дата Оторизация:
2005-07-08
Листовка
13
B. PACKAGE LEAFLET
14
PACKAGE LEAFLET FOR
EQUILIS TE SUSPENSION FOR INJECTION FOR HORSES
1.
NAME AND ADDRESS OF THE MARKETING
AUTHORISATION HOLDER AND OF
THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH
RELEASE, IF DIFFERENT
Intervet International B.V.
Wim de Körverstraat 35
5831 AN Boxmeer
The Netherlands
2.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Equilis Te suspension for injection for horses
3.
STATEMENT
OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
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
A clear opalescent suspension.
4.
INDICATION(S)
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
5.
CONTRAINDICATIONS
None.
6.
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.
15
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).
If y
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Данни за продукта
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Equilis Te suspension for injection for horses
2.
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 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
24 months after the first revaccination
4.3
CONTRAINDICATIONS
None.
4.4
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.
4.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
Only healthy animals should be vaccinated.
3
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.
4.6
ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS)
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 occ
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