Tolfine

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Tolfenamic acid

Available from:

Vetoquinol Ireland Limited

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:

Cattle, Pigs

Therapeutic area:

tolfenamic acid

Therapeutic indications:

N.S.A.I.D.

Authorization status:

Authorised

Authorization date:

2000-02-04

Summary of Product characteristics

_[Version 8.1,01/2017] _
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Tolfine
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
ACTIVE SUBSTANCE
Tolfenamic acid
40 mg
EXCIPIENTS
Benzyl alcohol
10.4 mg
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Cattle and Pigs.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Tolfine is indicated:
-
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.
4.3
CONTRAINDICATIONS
Do not use in case of hypersensitivity to the active substance.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
Do not exceed 20 ml per injection site.
4.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
Do not exceed the stated dosage and duration of treatment.
Use aseptic precautions when administering the product.
Special precautions to be taken by the person administering the
veterinary medicinal product to
animals
None known.
4.6
ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS)
There are occasional reports of collapse following rapid intravenous
injection in cattle.
When administering intravenously, the product should be injected
slowly. At the first signs of
intolerance, the injection should be interrupted.
4.7
USE DURING PREGNANCY, LACTATION OR LAY
The product may be used during pregnancy and lactation.
4.8
INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTION
Do not administer other NSAIDs concurrently or within 24 hours of each
other. Tolfenamic acid is
highly bound to plasma proteins and may compete with other highly
bound drugs.
4.9
AMOUNTS TO BE ADMINISTERED AND ADMINISTRATION ROUTE
For inflammation associated with respiratory disease in cattle, the
recommended dosage is 2 mg/kg (1
ml/20 kg bodyweight) by intramuscular injectio