TOLFEDOL, 40 mg/ml, solution for injection for cattle, pigs, cats and dogs

Страна: Ирландия

Език: английски

Източник: HPRA (Health Products Regulatory Authority)

Активна съставка:

Tolfenamic acid

Предлага се от:

SP Veterinaria, S.A.

АТС код:

QM01AG02

INN (Международно Name):

Tolfenamic acid

дозиране:

40 milligram(s)/millilitre

Лекарствена форма:

Solution for injection

Вид предписание :

POM: Prescription Only Medicine as defined in relevant national legislation

Терапевтична група:

Cats, Cattle, Dogs, Pigs

Терапевтична област:

tolfenamic acid

Терапевтични показания:

N.S.A.I.D.

Статус Оторизация:

Authorised

Дата Оторизация:

2015-08-21

Данни за продукта

Health Products Regulatory Authority
05 February 2021
CRN009S1K
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
TOLFEDOL, 40 mg/ml, solution for injection for cattle, pigs, cats and
dogs
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
ACTIVE SUBSTANCE:
Tolfenamic acid ………………………………………………
40 mg
EXCIPIENTS:
Benzyl alcohol
(E1519)………………………………………..10.4 mg
Sodium formaldehyde sulphoxylate………………………….. 5 mg
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection.
A clear yellowish solution.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Cattle, pigs, cats and dogs.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
IN CATTLE
, as an adjunct in the treatment of pneumonia by improving general
conditions and nasal discharge and as an adjunct
in the treatment of acute mastitis.
IN PIGS, as an adjunct in the treatment of Metritis Mastitis Agalactia
syndrome.
IN DOGS
: for the treatment of inflammation associated with musculo-skeletal
disorders and for the reduction of post-operative
pain.
IN CATS : as an adjunct in the treatment of upper respiratory disease
in association with antimicrobial therapy, if appropriate.
4.3 CONTRAINDICATIONS
Do not use in cases of cardiac disease.
Do not use in cases of impaired hepatic function or acute renal
insufficiency.
Do not use in cases of ulceration or digestive bleeding, in case of
blood dyscrasia.
Do not inject intramuscularly in cats.
Do not use in known cases of hypersensitivity to the active substance
or to any of the excipients.
Do not use in dehydrated, hypovolaemic or hypotonic animals (due to
its potential risk of increasing renal toxicity).
Do not administer other steroidal or non – steroidal anti –
inflammatory drugs concurrently or within 24 hours of each other.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
NSAIDS can cause inhibition of phagocytosis and hence in the treatment
of inflammatory condi