Fatroseal 2.6 g Intramammary Suspension for Dry Cows

Country: United Kingdom

Language: English

Source: VMD (Veterinary Medicines Directorate)

Active ingredient:

Bismuth Subnitrate

Available from:

Fatro S.p.A.

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:

2022-03-30

Summary of Product characteristics

Revised: June 2022
AN: 00394/2022
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
FATROSEAL 2.6 g intramammary suspension for dry cows
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
Intramammary suspension.
White to greyish homogeneous suspension.
4. CLINICAL PARTICULARS
4.1
TARGET SPECIES
Cattle (dairy cows 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
product can be used
alone in dry cow management and mastitis control.
4.3
CONTRAINDICATIONS
Do not use in lactating cows. See section 4.7.
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 known cases of hypersensitivity to the active substance
or to any of the
excipients.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
Selection of cows for treatment 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.
Revised: June 2022
AN: 00394/2022
Page 2 of 6
4.5
SPECIAL PRECAUTIONS FOR USE
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
minimize the risk of
acute mastitis due to poor infusion technique and lack of hygien