Boviseal Dry cow intramammary suspension

Maa: Irlanti

Kieli: englanti

Lähde: HPRA (Health Products Regulatory Authority)

Aktiivinen ainesosa:

Bismuth subnitrate, heavy

Saatavilla:

Zoetis Belgium S.A.

ATC-koodi:

QG52X

INN (Kansainvälinen yleisnimi):

Bismuth subnitrate, heavy

Annos:

2.6 gram(s)

Lääkemuoto:

Intramammary suspension

Prescription tyyppi:

LR: Licensed Retailer as defined in national legislation

Terapeuttinen alue:

VARIOUS PRODUCTS FOR TEATS AND UDDER

Valtuutuksen tilan:

Authorised

Valtuutus päivämäärä:

2020-11-20

Valmisteyhteenveto

ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Orbeseal Dry Cow 2.6 g intramammary suspension for cattle [AT, BE, BG,
HR, CY, DE, FI, EL, IT,
LU, NL, NO, PT, RO, SI, ES, SE, United Kingdom (NI)]
Orbesealer Vet – 2.6 g intramammary suspension for cattle [DK]
Boviseal Dry cow intramammary suspension for cattle [IE]
Orbeseal Dry cow intramammary suspension for cattle [FR]
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 4 g intramammary syringe contains:
ACTIVE SUBSTANCE:
Bismuth subnitrate, heavy
2.6 g
(equivalent to Bismuth, heavy
1.858 g)
EXCIPIENTS:
QUALITATIVE COMPOSITION OF EXCIPIENTS AND
OTHER CONSTITUENTS
Liquid paraffin
Aluminium Di Tri Stearate
Silica, Colloidal Anhydrous
Greyish white, smooth, unctuous intramammary suspension.
3.
CLINICAL INFORMATION
3.1
TARGET SPECIES
Cattle (dairy cow at drying-off).
3.2
INDICATIONS FOR USE FOR EACH TARGET SPECIES
Prevention of new intramammary infections throughout the dry period.
In cows considered likely to be free of sub-clinical mastitis, the
veterinary medicinal product can be
used on its own in dry cow management and mastitis control.
3.3
CONTRAINDICATIONS
See section 3.7 “Use during pregnancy, lactation or lay”. Do not
use the veterinary medicinal 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.
3.4
SPECIAL WARNINGS
Selection of cows for treatment with the veterinary medicinal 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 subclinical mastitis or
bacteriology sampling.
3.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for safe use in the target species:
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 st