Norodine Equine Oral Paste

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Trimethoprim; Sulfadiazine

Available from:

Norbrook Laboratories (Ireland) Limited

ATC code:

QJ01E

INN (International Name):

Trimethoprim; Sulfadiazine

Dosage:

5.8, 28.83 percent weight/weight

Pharmaceutical form:

Oral paste

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic area:

SULFONAMIDES AND TRIMETHOPRIM

Authorization status:

Authorised

Authorization date:

1988-10-01

Summary of Product characteristics

Health Products Regulatory Authority
04 June 2020
CRN009J7W
Page 1 of 3
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Norodine Equine Oral Paste
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 4.31g dose contains:
Active Substances
Trimethoprim
5.80
%w/w
Sulfadiazine
28.83
%w/w
Excipients
Methyl Parahydroxybenzoate (E218)
0.18
%w/w
Propyl Parahydroxybenzoate (E216)
0.02
%w/w
3 PHARMACEUTICAL FORM
Oral paste.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Horses.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Norodine Equine Paste is indicated in the treatment of bacterial
infections in horses caused by sensitive micro-organisms
including:
_Escherichia coli_
_Staphylococcus _spp.
_Streptococcus _spp.
4.3 CONTRAINDICATIONS
Contraindicated in horses with known sulphonamide sensitivity and also
in animals with hepatic damage or blood dyscrasias.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
No special precautions.
4.5 SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTION(S) FOR USE IN ANIMALS
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
None.
Health Products Regulatory Authority
04 June 2020
CRN009J7W
Page 2 of 3
4.6 ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS)
No undesirable effects.
4.7 USE DURING PREGNANCY, LACTATION OR LAY
Norodine Equine Paste can be safely administered during pregnancy and
lactation.
4.8 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTIONS
No known interactions.
4.9 AMOUNTS TO BE ADMINISTERED AND ADMINISTRATION ROUTE
Adjust screw gauge on dial-a-dose plunger to the bodyweight of the
horse. Remove cap from nozzle. Place nozzle in the
corner of mouth. Depress plunger depositing paste on upper surface of
tongue.
The daily dose is 30mg of combined actives per kg bodyweight by oral
administration. Treatment should be continued until 2
days afte