Norodine Equine Oral Paste

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Trimethoprim; Sulfadiazine

Available from:

Norbrook Laboratories Limited

ATC code:

QJ01E

INN (International Name):

Trimethoprim; Sulfadiazine

Dosage:

percent

Pharmaceutical form:

Oral paste

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic group:

Horses

Therapeutic area:

SULFONAMIDES AND TRIMETHOPRIM

Therapeutic indications:

Antibacterial

Authorization status:

Authorised

Authorization date:

1988-10-01

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Norodine Equine Oral Paste.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
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.
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
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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.
4.6 ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS)
No undesirable effects.
4.7 USE DURING PREGN