Noroseal 2.6 g Intramammary Suspension for Cattle

Land: Ierland

Taal: Engels

Bron: HPRA (Health Products Regulatory Authority)

Werkstoffen:

Bismuth subnitrate, heavy

Beschikbaar vanaf:

Norbrook Laboratories Limited

ATC-code:

QG52X

INN (Algemene Internationale Benaming):

Bismuth subnitrate, heavy

Dosering:

2.6 g/syringe

farmaceutische vorm:

Intramammary suspension

Prescription-type:

LM: Licensed Merchant as defined in relevant national legislation

Therapeutische categorie:

Cattle

Therapeutisch gebied:

VARIOUS PRODUCTS FOR TEATS AND UDDER

therapeutische indicaties:

Antibacterial

Autorisatie-status:

Authorised

Autorisatie datum:

2013-07-26

Productkenmerken

Health Products Regulatory Authority
03 August 2018
CRN000X1F
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Noroseal 2.6 g Intramammary Suspension for Cattle
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 4g Intramammary syringe contains:
ACTIVE SUBSTANCE:
​
Bismuth subnitrate, heavy
​2.6g
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Intramammary suspension.
Light brown suspension.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Cattle (dairy cows)
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Prevention of new intramammary infections throughout the dry period.
In cows considered likely to be free of sub-clinical mastitis, the
product may be
suitable for use on its own in dry cow management for mastitis
control.
Selection of cows for treatment with the product should be based on
veterinary
clinical judgement. Selection criteria may be based on the mastitis
and cell count
history of individual cows, or recognised tests for the detection of
sub-clinical
mastitis such as bacteriological sampling.
4.3 CONTRAINDICATIONS
See section 4.7. Do not use in lactating cows. Do not use the product
alone in cows
with sub-clinical mastitis at drying off. Do not use in cows with
clinical mastitis at
drying off.
Do not use in cases of hypersensitivity to the active substance or to
any of the
excipients.
Health Products Regulatory Authority
03 August 2018
CRN000X1F
Page 2 of 5
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
4.5 SPECIAL PRECAUTIONS FOR USE
(i) Special precautions for use in animals
It is good practice to observe dry cows regularly for signs of
clinical mastitis. If a
sealed quarter develops clinical mastitis, the affected quarter should
be stripped out
manually before appropriate therapy is instituted.
To reduce the risk of contamination, do not immerse the syringe in
water.
Use the syringe only once.
It is important to observe strict aseptic technique for the
administration of the
product, because the product does not have antimicrobia