Duphatrim 80 Tablets Sulfadiazine 400 mg and Trimethoprim 80 mg

Krajina: Spojené kráľovstvo

Jazyk: angličtina

Zdroj: VMD (Veterinary Medicines Directorate)

Aktívna zložka:

Sulfadiazine, Trimethoprim

Dostupné z:

Pfizer Ltd

ATC kód:

QJ01EW10

INN (Medzinárodný Name):

Sulfadiazine, Trimethoprim

Stav Autorizácia:

Expired

Súhrn charakteristických

Revised: March 2010
AN: 01846/2009
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Duphatrim 80 Tablets
Sulfadiazine 400 mg & Trimethoprim 80 mg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION ACTIVE SUBSTANCES
Per Tablet
Sulfadiazine
400 MG
Trimethoprim
80 MG
EXCIPIENT(S):
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
Indicated for the treatment of alimentary tract infections,
respiratory and
urogenital infections, skin and wound infections and eye and ear
infections
caused by susceptible organisms.
4.3 CONTRAINDICATIONS
Do not use in cats.
4.4 SPECIAL WARNINGS
None.
4.5 SPECIAL PRECAUTIONS FOR USE
i. Special precautions for use in animals
Not recommended in dogs known to be hypersensitive or with severe
hepaticdysfunction.
Revised: March 2010
AN: 01846/2009
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.
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 potential
sulphonamides. If either of these conditions occur, it is recommended
that
medication is stopped and that future treatment is avoided.
4.7
USE DURING PREGNANCY, LACTATION OR LAY
Can be safely administered during pregnancy and lactation.
4.8
INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTION
None known.
4.9 AMOUNTS TO BE ADMINISTERED AND ADMINISTRATION ROUTE
The daily dose is one tablet per 16 kg bodyweight administered orally,
providing
30 mg of combined active ingredients per bodyweight. Treatment should
be
continued for up to five days or until 2 days after symptoms have
subsided.
4.10 OVERDOSE (SYMPTOMS, EMERGENCY PROCEDURES, ANTIDOTES), IF
NECESSARY
Not applicable.