Tolfedine 4% w/v Solution for Injection for dogs and cats

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:

4 percent weight/volume

Pharmaceutical form:

Solution for injection

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic group:

Cats, Dogs

Therapeutic area:

tolfenamic acid

Therapeutic indications:

N.S.A.I.D.

Authorization status:

Authorised

Authorization date:

1993-08-12

Summary of Product characteristics

_ _
_[Version 8.1, 01/2017] _
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Tolfedine 4% w/v Solution for Injection for dogs and cats
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
Sterile solution for injection.
A clear colourless to slightly yellow sterile aqueous solution.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Dogs, Cats.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
IN DOGS
: inflammatory and painful post-operative syndromes.
IN CATS
: adjuvant treatment of upper respiratory disease in association with
antimicrobial therapy.
4.3
CONTRAINDICATIONS
Tolfenamic acid is contraindicated in case of cardiac disease.
Do not use in animals with impaired hepatic function or acute renal
insufficiency.
Tolfenamic acid is contraindicated in case of ulceration or digestive
bleeding, in case of blood
dyscrasia or hypersensivitivy to tolfenamid acid.
Do not inject intramuscularly in cats.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
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.
The use of insulin-type needle/syringe is advisable particularly in
low-weight animals to ensure an
accurate dose.
4.5
SPECIAL PRECAUTIONS FOR USE
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 is essential.
Reduced metabolism and excretion in these animals should be
considered.
Avoid use in any dehydrated, hypovolemic 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