Norodine 480 mg Tablets

Land: Irland

Språk: engelsk

Kilde: HPRA (Health Products Regulatory Authority)

Aktiv ingrediens:

Trimethoprim; Sulfadiazine

Tilgjengelig fra:

Norbrook Laboratories (Ireland) Limited

ATC-kode:

QJ01EW10

INN (International Name):

Trimethoprim; Sulfadiazine

Dosering :

80, 400 mg/tablet

Legemiddelform:

Tablet

Resept typen:

POM: Prescription Only Medicine as defined in relevant national legislation

Terapeutisk område:

sulfadiazine and trimethoprim

Autorisasjon status:

Authorised

Autorisasjon dato:

1988-10-01

Preparatomtale

Health Products Regulatory Authority
30 January 2019
CRN008TJD
Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Norodine 480 mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
​
Each tablet contains:
​
​
ACTIVE SUBSTANCES:
​
Trimethoprim
​
​
80 mg
​
Sulfadiazine
​
400 mg
​
EXCIPIENTS:
For a full list of excipients see section 6.1.
​
3 PHARMACEUTICAL FORM
Tablet.
An off-white circular tablet scored on one side.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Dogs
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
_In vitro_, Norodine is effective against most common Gram-positive
and
Gram-negative bacteria including _Escherichia coli_, _Klebsiella
pneumonia, Pasteurella _
_multocida, Streptococcus _spp., _Staphylococcus _spp., _Salmonella
_spp., _Corynebacterium _
spp. _Proteus mirabilis _and _Citrobacter freundii._
When susceptible organisms are present, Norodine 480 mg Tablets are
indicated for
oral use in dogs for the treatment of alimentary tract infections,
respiratory and
urogenital infections, skin and wound infections and eye and ear
infections.
4.3 CONTRAINDICATIONS
Do not use in cats. Do not use in animals with known hypersensitivity
to the active
ingredients.
Health Products Regulatory Authority
30 January 2019
CRN008TJD
Page 2 of 4
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
4.5 SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
None.
SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE
PRODUCT TO
ANIMALS
None.
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
sulfonamides. 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
Norodine 480 mg Tablets can be safely administered during pregnancy
and lactation.
4.8 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND