Norodine Bolus

Ülke: İrlanda

Dil: İngilizce

Kaynak: HPRA (Health Products Regulatory Authority)

Aktif bileşen:

Sulfadiazine ; Trimethoprim

Mevcut itibaren:

Norbrook Laboratories (Ireland) Limited

ATC kodu:

QJ01EW10

INN (International Adı):

Sulfadiazine ; Trimethoprim

Doz:

1000, 200 mg/tablet

Farmasötik formu:

Tablet

Reçete türü:

POM: Prescription Only Medicine as defined in relevant national legislation

Terapötik alanı:

sulfadiazine and trimethoprim

Yetkilendirme durumu:

Authorised

Yetkilendirme tarihi:

1988-10-01

Ürün özellikleri

Health Products Regulatory Authority
24 January 2019
CRN008TFG
Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Norodine Bolus
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5.6g tablet contains
ACTIVE SUBSTANCES
Trimethoprim 200 mg
Sulphadiazine 1.0 g
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Calves
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Norodine Bolus is indicated primarily for the treatment of bacterial
scours but may
also be used for the treatment of acute salmonellosis and bacterial
pneumonia.
4.3 CONTRAINDICATIONS
Norodine Bolus should not be administered to animals with functionally
mature
rumens.
Do not administer to animals with known hypersensitivity to the active
ingredients.
Do not use in animals with severe liver or kidney parenchymal damage
or blood
dyscrasias.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
None
Health Products Regulatory Authority
24 January 2019
CRN008TFG
Page 2 of 4
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.
SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE
VETERINARY
MEDICINAL PRODUSCT TO ANIMALS
None.
4.6 ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS)
None
4.7 USE DURING PREGNANCY, LACTATION OR LAY
Not applicable
4.8 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTIONS
None known.
4.9 AMOUNTS TO BE ADMINISTERED AND ADMINISTRATION ROUTE
Norodine Bolus may be administered whole by hand or by balling gun.
One bolus per 40 kg bodyweight daily. This gives 30 mg of combined
active
ingredients per kg bodyweight.
To ensure correct dosage body weight should be determined as
accurately as
possible.
Treatment should be repeated daily until two d