Tolfine 80 mg/ml solution for injection for cattle

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

Pharmaceutical form:

Solution for injection

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic area:

tolfenamic acid

Authorization date:

2022-08-26

Summary of Product characteristics

1
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Tolfine 80 mg/ml (Austria, Belgium, Cyprus, Czech Republic, Estonia,
France, Germany, Greece,
Ireland, Italy, Latvia, Lithuania, Luxembourg, Netherlands, Poland,
Portugal, Slovakia, Slovenia, Spain)
solution for injection for cattle
Tolfacton (Denmark, Finland) solution for injection for cattle
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
ACTIVE SUBSTANCE:
Tolfenamic acid
80 mg
EXCIPIENTS:
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection.
Clear colourless to slightly yellow-brown solution.
4.
CLINICAL PARTICULARS
Cattle
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
The veterinary medicinal product is indicated as:
- Adjunct treatment for the reduction of acute inflammation associated
with respiratory diseases.
- Adjunct treatment of acute mastitis.
4.3
CONTRAINDICATIONS
Do not uses in cases of cardiac disease.
Do not use in ca ses of impaired hepatic function or acute renal
insufficiency.
Do not use in cases of ulceration or digestive bleeding or in cases of
blood dyscrasia.
Do not use in cases of hypersensitivity to the active substance or to
any of the excipients.
Do not administer other steroidal or non-steroidal anti-inflammatory
drugs concurrently or within 24
hours of each other.
Do not use in dehydrated, hypovolaemia or hypotensive animals, due to
its potential risk of renal
toxicity.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
Non-steroidal anti-inflammatory drugs (NSAIDs) can cause inhibition of
phagocytosis and hence in the
treatment of inflammatory conditions associated with bacterial
infections appropriate concurrent
antimicrobial therapy should be instigated.
4.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
4.1
TARGET SPECIES
2
Do not exceed the stated dosage and duration of treatment. Use aseptic
precautions when administering
the product.
Concurrent administration of potential nephrotoxic drugs should be
avoided.
Young and aged animals are more sensitive to t