Tolfedine Tablets 20 mg

Страна: Велика Британія

мова: англійська

Джерело: VMD (Veterinary Medicines Directorate)

Активний інгредієнт:

Tolfenamic Acid

Доступна з:

Vetoquinol UK Ltd

ІПН (Міжнародна Ім'я):

Tolfenamic Acid

Фармацевтична форма:

Tablet

Тип рецепту:

POM-V - Prescription Only Medicine – Veterinarian

Терапевтична група:

Dogs

Терапевтична области:

Anti Inflammatory NSAID

Статус Авторизація:

Authorized

Дата Авторизація:

1993-10-15

Характеристики продукта

Revised: October 2023
AN: 01786/2023
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE VETERINARY MEDICINAL PRODUCT
Tolfedine Tablets 20mg
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains:
Tolfenamic acid
20mg
FOR A FULL LIST OF EXCIPIENTS, SEE SECTION 6.1
3. PHARMACEUTICAL FORM
Tablet
White convex tablets, divisible in two.
4. CLINICAL PARTICULARS
4.1
TARGET SPECIES
Dogs
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Treatment for the alleviation of inflammation and pain and chronic
locomotor disease
in dogs.
IN SMALL DOGS : in pathologies of osteoarticular and musculoskeletal
systems.
4.3 CONTRA-INDICATIONS
Do not administer to animals suffering from cardiac, hepatic or renal
disease, where
there is a possibility of gastro-intestinal ulceration or bleeding,
where there is
evidence of a blood dyscrasia or hypersensitivity to the product.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
Long term treatment of over 3 months duration should be under regular
veterinary
supervision. In particular, dogs with hepatic insufficiency should be
closely
monitored.
See also 4.5
Revised: October 2023
AN: 01786/2023
Page 2 of 5
4.5 SPECIAL PRECAUTIONS FOR USE
(I) SPECIAL PRECAUTIONS FOR USE IN ANIMALS
Use in animals less than 6 weeks of age, or in aged animals, may
involve additional
risk. If such a use cannot be avoided, animals may require a reduced
dosage and
careful clinical management.
Avoid use in any dehydrated, hypovolaemic or hypotensive animal, as
there is a
potential risk of increased renal toxicity.
Concurrent administration of potential nephrotoxic drugs should be
avoided.
It is preferable that the product is not administered to animals
undergoing general
anaesthesia until fully recovered.
Do not exceed the prescribed dosage or duration of treatment.
Animals
suffering
from
a
chronic
renal
insufficiency
and
requiring
an
anti-
inflammatory treatment may be treated with Tolfenamic acid without
requiring an
adjustment of the dosage. However, the use of this product is
contra-indicated i