Sureseal 2.6 g Intramammary Suspension for Cattle

Land: Irland

Sprog: engelsk

Kilde: HPRA (Health Products Regulatory Authority)

Aktiv bestanddel:

Bismuth subnitrate, heavy

Tilgængelig fra:

Norbrook Laboratories (Ireland) Limited

ATC-kode:

QG52X

INN (International Name):

Bismuth subnitrate, heavy

Dosering:

2.6 g/syringe

Lægemiddelform:

Intramammary suspension

Recept type:

LR: Licensed Retailer as defined in national legislation

Terapeutisk område:

VARIOUS PRODUCTS FOR TEATS AND UDDER

Autorisation status:

Authorised

Autorisation dato:

2013-07-26

Produktets egenskaber

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Sureseal 2.6g Intramammary Suspension for Cattle (IE, FR, UK)
Noroseal 2.6g Intramammary Suspension for Cattle (BE, ES, IT, NL, PT)
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.
4.4
SPECIAL WARNINGS
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.
Since the product does not have antimicrobial activity, in order to
minimise the risk of acute mastitis due to poor infusion technique and
lack of hygiene (see section 4.6), it is crucial to follow the aseptic
technique of administ