Orbeseal Dry Cow 2.6g Intramammary Suspension

Država: Velika Britanija

Jezik: engleski

Izvor: VMD (Veterinary Medicines Directorate)

Aktivni sastojci:

Bismuth Subnitrate

Dostupno od:

Zoetis UK Limited

ATC koda:

QG52X

INN (International ime):

Bismuth Subnitrate

Farmaceutski oblik:

Intramammary suspension

Tip recepta:

POM-V - Prescription Only Medicine – Veterinarian

Terapijska grupa:

Cattle

Područje terapije:

Miscellaneous Mechanical Teat Seal

Status autorizacije:

Authorized

Datum autorizacije:

2002-06-25

Svojstava lijeka

Revised: September 2023
AN: 01846/2022
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Orbeseal Dry Cow 2.6 g intramammary suspension for cattle
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)
EXCIPIENT(S):
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Greyish white, smooth, unctuous intramammary suspension.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Cattle (dairy cow at drying-off).
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
veterinary
medicinal product can be used on its own in dry cow management and
mastitis control.
4.3
CONTRAINDICATIONS
See section 4.7. 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.
Revised: September 2023
AN: 01846/2022
Page 2 of 6
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
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.
4.5
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
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 veterinary medicinal product does not have antimicrobial
activity, in
or