Norodine 24 % Solution for Injection

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 :

24 percent weight/volume

Legemiddelform:

Solution for injection

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

_ _
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Norodine 24% Solution for Injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
Active substances
Trimethoprim
40 mg
Sulfadiazine
200 mg
Excipients
Chlorocresol
1 mg
Sodium Formaldehyde Sulfoxylate
1 mg
N-Methyl Pyrrolidone
0.5 ml
For a full list of excipients see section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection.
A clear, yellow aqueous solution.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Horses, cattle, pigs, cats and dogs.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
The product is indicated in the treatment of systemic infections
caused by or associated with
organisms sensitive to the Trimethoprim : Sulphadiazine combination.
The spectrum of activity
includes both Gram positive and Gram negative organisms including
Actinobacilli
_Klebsiella _
spp.
_Bordetella _
spp.
_Pasteurella _
spp.
Corynebacteria
_Salmonella _
spp.
_Eschericia coli_
Staphylococci
_Haemophilus _
spp.
Streptococci
_ _
_ _
4.3 CONTRAINDICATIONS
The product should not be administered intraperitoneally.
Do not administer to animals known to be hypersensitive to the active
ingredients.
Do not administer to animals with known sulphonamide sensitivity or
severe liver or kidney
parenchymal damage or blood dyscrasias.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
Adequate drinking water should be available during the therapeutic
effect of the product.
Avoid the introduction of contamination during use.
Should any apparent growth or discolouration occur the product should
be discarded.
4.5 SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
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
(regional, farm level)
epidemiological information about susceptibility of the target
bacteria.
Use of the product deviating from the instructions given in the SPC
may increase the prevalence
of bacteria resistant to the produc