Trimedoxine 80 Tablets

Country: United Kingdom

Language: English

Source: VMD (Veterinary Medicines Directorate)

Active ingredient:

Sulfadiazine, Trimethoprim

Available from:

Vetoquinol UK Ltd

ATC code:

QJ01EW10

INN (International Name):

Sulfadiazine, Trimethoprim

Pharmaceutical form:

Tablet

Prescription type:

POM-V - Prescription Only Medicine – Veterinarian

Therapeutic group:

Dogs

Therapeutic area:

Antimicrobial

Authorization status:

Authorized

Authorization date:

1994-05-11

Summary of Product characteristics

Vm 08007/4055
February 2005
SPC_121510.DOC
Page 1 of 4
Vm 08007/4055
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Trimedoxine 80 Tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains Trimethoprim 80mg and Sulfadiazine 400mg.
FOR A FULL LIST OF EXCIPIENTS, SEE SECTION 6.1
3.
PHARMACEUTICAL FORM
Tablet.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Dogs
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
When susceptible organisms are present, the product may be effective
in treating the following conditions: alimentary tract infections,
respiratory and urogenital infections, skin and wound infections and
eye and ear infections.
4.3
CONTRA-INDICATIONS
Trimedoxine 80 tablets are not suitable for use in cats.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
No special warnings.
4.5
SPECIAL PRECAUTIONS FOR USE
(I) SPECIAL PRECAUTIONS FOR USE IN ANIMALS
No special precautions.
(II) SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE
VETERINARY MEDICINAL PRODUCT TO ANIMALS
Wash hands after use.
If accidental ingestion occurs, seek medical advice immediately.
For animal treatment only
Vm 08007/4055
February 2005
SPC_121510.DOC
Page 2 of 4
Vm 08007/4055
4.6
ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS)
A low incidence of polyarthropathy and keratoconjunctivitis sicca (dry
eye) has been reported in dogs following oral administration of
potentiated sulphonamides. If either of these conditions occur, it is
recommended that medication is stopped and that future treatment with
similar products is avoided.
Sulphonamide hypersensitivity is rare in companion animals but should
be considered in cases of unexpected responses to treatment.
4.7
USE DURING PREGNANCY, LACTATION OR LAY
Can be safety administered during pregnancy and lactation.
4.8
INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTION
No known interactions.
4.9
Amounts to be administered and administration route
The daily dose is one tablet per 16kg bodyweight administered orally,
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