Norodine 20 Coated Tablets

Nazione: Regno Unito

Lingua: inglese

Fonte: VMD (Veterinary Medicines Directorate)

Principio attivo:

Sulfadiazine, Trimethoprim

Commercializzato da:

Norbrook Laboratories Limited

Codice ATC:

QJ01EW10

INN (Nome Internazionale):

Sulfadiazine, Trimethoprim

Forma farmaceutica:

Coated tablet

Tipo di ricetta:

POM-V - Prescription Only Medicine – Veterinarian

Gruppo terapeutico:

Cats, Dogs

Area terapeutica:

Antimicrobial

Stato dell'autorizzazione:

Expired

Data dell'autorizzazione:

1987-11-20

Scheda tecnica

Revised 20 November 2008
AN: 02405/2007
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Norodine 20 Coated Tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE SUBSTANCE:
Each tablet contains:
Trimethoprim 20mg
Sulfadiazine 100 mg.
EXCIPIENTS:
Titanium dioxide (E171) 0.27mg.
For a full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Coated tablet.
An off white, sugar coated, unscored, circular tablet.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Dogs
Adult Cats
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Alimentary tract infections, respiratory and urogenital infections,
skin and
wound infections, and eye and ear infections where susceptible
organisms
are present
4.3
CONTRAINDICATIONS
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 occurs, it is recommended
that
medication is stopped and that future treatment with similar products
is
avoided.
4.3
SPECIAL WARNINGS FOR EACH TARGET SPECIES
None
Revised 20 November 2008
AN: 02405/2007
4.5
SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
The tablets should not be divided.
When given to cats the tablets should not be crushed before
administration.
Maintain adequate fluid intake during treatment.
Not to be used in cases of hepatic renal impairment or blood dyscrasia
Use of the product should be based on susceptibility testing of the
bacteria
isolated from the animal. If this is not possible, therapy should be
based on
local epidemiological information.
SPECIAL
PRECAUTIONS
TO
BE
TAKEN
BY
THE
PERSON
ADMINISTERING
THE
VETERINARY MEDICINAL PRODUCT TO ANIMALS
Take care to avoid skin contact. Wash hands after use.
Sulphonamides
may
cause
hypersensitivity
(allergy)
following
injection,
inhalation, ingestion or skin contact. Hypersensitivity to
sulphonamides may
lead to cross reactions with other antibiotics. Allergic reactions to
these
substances may occasionall