Tolfine, 4% Solution for Injection for Cattle and Pigs

Country: United Kingdom

Language: English

Source: VMD (Veterinary Medicines Directorate)

Active ingredient:

Tolfenamic Acid

Available from:

Vetoquinol UK Ltd

INN (International Name):

Tolfenamic Acid

Pharmaceutical form:

Solution for injection

Prescription type:

POM-V - Prescription Only Medicine – Veterinarian

Therapeutic group:

Cattle, Pigs

Therapeutic area:

Anti Inflammatory NSAID

Authorization status:

Expired

Authorization date:

1999-05-19

Summary of Product characteristics

Revised: 14 May 2008
AN: 00930/2007
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Tolfine, 4% solution for injection for cattle and pigs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains 4.0% w/v tolfenamic acid as active ingredient with
1.04%
w/v benzyl alcohol and 0.50% w/v sodium formaldehyde sulphoxylate as
preservatives.
For a full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Solution for injection. Clear, colourless to slightly yellow, slightly
viscous
solution
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Cattle and pigs.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
An anti-inflammatory, antipyretic and analgesic agent indicated:-
In cattle:
-as an adjunct in the treatment of acute mastitis, used in conjunction
with
antibacterial therapy
-as an aid in the control of acute inflammation associated with
bacterial
respiratory disease, used in conjunction with antibacterial therapy.
In pigs, as an adjunct in the treatment of Metritis Mastitis Agalactia
syndrome, used in conjunction with antibacterial therapy.
4.3
CONTRA-INDICATIONS
Not for IM administration in cattle.
Not for IV or SC administration in pigs.
Not for SC administration in dairy cows
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
Revised: 14 May 2008
AN: 00930/2007
Do not exceed 20ml per intramuscular injection site.
Do not exceed the stated dose or the duration of treatment.
Use is contra-indicated in animals suffering from cardiac, hepatic or
renal
disease, where there is the possibility of gastro-intestinal
ulceration or
bleeding, or where there is evidence of hypersensitivity to the
product.
Do not administer other NSAIDs concurrently or within 24 hours of each
other. Some NSAIDs may be highly bound to plasma proteins and
compete with other highly bound drugs which can lead to toxic effects.
Use in any animal less than 6 weeks of age or in aged animals may
involve additional risk. If such use cannot be avoided animals may
require
a reduced dosage and careful clinical manage