Norodine Equine Oral Paste

Land: Vereinigtes Königreich

Sprache: Englisch

Quelle: VMD (Veterinary Medicines Directorate)

Wirkstoff:

Sulfadiazine, Trimethoprim

Verfügbar ab:

Norbrook Laboratories Limited

ATC-Code:

QJ01EW10

INN (Internationale Bezeichnung):

Sulfadiazine, Trimethoprim

Darreichungsform:

Oral paste

Verschreibungstyp:

POM-V - Prescription Only Medicine – Veterinarian

Therapiegruppe:

Horses

Therapiebereich:

Antimicrobial

Berechtigungsstatus:

Authorized

Berechtigungsdatum:

1988-01-19

Fachinformation

Revised: February 2020
AN: 01502/2019
Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
NORODINE EQUINE ORAL PASTE
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE SUBSTANCE:
Trimethoprim
5.80 %w/w
Sulfadiazine
28.83 %w/w
EXCIPIENTS:
Methyl Parahydroxybenzoate
0.18 %w/w
Propyl Parahydroxybenzoate
0.02 %w/w
For the full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Oral Paste.
A creamy white paste for oral administration.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Horses.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Indicated in the treatment of bacterial infections in horses caused by
sensitive
microorganisms including:
_Escherichia coli_
_Rhodococcus (Corynebacterium) equi_
_Staphylococcus _spp
_Streptococcus _spp
The product may be effective in alimentary tract infections including
diarrhoea,
respiratory
infections
including
pneumonia,
pleurisy,
strangles,
wounds,
septicaemia and general infections.
4.3
CONTRA-INDICATIONS
None.
Revised: February 2020
AN: 01502/2019
Page 2 of 4
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
No special precautions.
4.5
SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
Use of the following product should be based on susceptibility testing
and
take into account official and local antimicrobial policies. Not
recommended in
horses with known hypersensitivity, severe hepatic dysfunction or
cardiac
arrhythmias.
Do not use the same syringe to treat more than one animal unless
horses are
running together or in direct contact with each other on the same
premises.
SPECIAL
PRECAUTIONS
TO
BE
TAKEN
BY
THE
PERSON
ADMINISTERING
THE
VETERINARY MEDICINAL PRODUCT TO ANIMALS
Take care to avoid skin and eye contact. Gloves and suitable eye
protection
should be worn whilst handling this product. Wash hands and exposed
skin
after use.
Sulphonamides
may
cause
hypersensitivity
(allergy)
following
injection,
inhalation, ingestion or skin contact. Hypersensitivity to
sulphonamides may
lead to cross reactions with other antibi