Orbeseal Dry Cow 2.6g Intramammary Suspension

Country: United Kingdom

Language: English

Source: VMD (Veterinary Medicines Directorate)

Active ingredient:

Bismuth Subnitrate

Available from:

Zoetis UK Limited

ATC code:

QG52X

INN (International Name):

Bismuth Subnitrate

Pharmaceutical form:

Intramammary suspension

Prescription type:

POM-V - Prescription Only Medicine – Veterinarian

Therapeutic group:

Cattle

Therapeutic area:

Miscellaneous Mechanical Teat Seal

Authorization status:

Authorized

Authorization date:

2002-06-25

Summary of Product characteristics

Revised: September 2023
AN: 01843/2022
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)
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.
Revised: September 2023
AN: 01843/2022
Page 2 of 6
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
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 ve