Sulfatrim (16 mg/ml + 80 mg/ml) Oral Drops

Χώρα: Ηνωμένο Βασίλειο

Γλώσσα: Αγγλικά

Πηγή: VMD (Veterinary Medicines Directorate)

Δραστική ουσία:

Sulfamethoxazole, Trimethoprim

Διαθέσιμο από:

Le Vet B.V.

Φαρμακολογική κατηγορία (ATC):

QJ01EW10

INN (Διεθνής Όνομα):

Sulfamethoxazole, Trimethoprim

Φαρμακοτεχνική μορφή:

Oral drops, solution

Τρόπος διάθεσης:

POM-V - Prescription Only Medicine – Veterinarian

Θεραπευτική ομάδα:

Bearded Dragons, Pigeons, Rabbits

Θεραπευτική περιοχή:

Antimicrobial

Καθεστώς αδειοδότησης:

Authorized

Ημερομηνία της άδειας:

2014-03-28

Αρχείο Π.Χ.Π.

Revised: July 2014
AN: 00432/2011
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Sulfatrim (16 mg/ml + 80 mg/ml) Oral Drops
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE SUBSTANCES PER ML:
Trimethoprim
16 mg
Sulfamethoxazole
80 mg
EXCIPIENT(S):
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Oral drops.
Colourless to light yellow solution.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Rabbits, pigeons and Bearded Dragons.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Treatment of gastrointestinal infections caused by protozoa (namely
coccidian)
sensitive to the combination of trimethoprim and sulfamethoxazole.
4.3
CONTRAINDICATIONS
Do not use in cases with severe renal or hepatic impairment.
Do not use the product for prophylaxis.
Do not use in cases of known hypersensitivity to the active substances
or the
excipients.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
This is a limited marketing authorisation and efficacy of the product
is supported
by
a very small amount
of
data for the
above
indications.
Suspected
lack of
efficacy of the product must be reported to the Marketing
Authorisation Holder or the
Veterinary Medicines Directorate.
As with all other anti-infectives, prolonged use may result in the
development of resistant
strains.
Revised: July 2014
AN: 00432/2011
Page 2 of 5
4.5
SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
Maintain patient hydration during treatment.
The product should be used with caution in patients with diminished
renal or
hepatic function, or urinary obstruction, due to the possible
increased risk of side
effects as a result of decreased drug clearance.
SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE
VETERINARY
MEDICINAL PRODUCT TO ANIMALS
People with known hypersensitivity to sulfonamides should avoid
contact with the
veterinary medicinal product.
In case of reaction of hypersensitivity after exposure (such as skin
rash), seek
medical advice and show the package leaflet o