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

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Tolfenamic acid

Available from:

SP Veterinaria, S.A.

ATC code:

QM01AG02

INN (International Name):

Tolfenamic acid

Dosage:

40 milligram(s)/millilitre

Pharmaceutical form:

Solution for injection

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic group:

Cats, Cattle, Dogs, Pigs

Therapeutic area:

tolfenamic acid

Therapeutic indications:

N.S.A.I.D.

Authorization status:

Authorised

Authorization date:

2015-08-21

Summary of Product characteristics

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