Fatroseal 2.6 g intramammary suspension for dry cows

देश: आयरलैंड

भाषा: अंग्रेज़ी

स्रोत: HPRA (Health Products Regulatory Authority)

सक्रिय संघटक:

Bismuth subnitrate, heavy

थमां उपलब्ध:

FATRO S.p.A.

ए.टी.सी कोड:

QG52X

INN (इंटरनेशनल नाम):

Bismuth subnitrate, heavy

फार्मास्यूटिकल फॉर्म:

Intramammary suspension

प्रिस्क्रिप्शन प्रकार:

LR: Licensed Retailer as defined in national legislation

चिकित्सीय क्षेत्र:

VARIOUS PRODUCTS FOR TEATS AND UDDER

प्राधिकरण की तारीख:

2022-04-01

उत्पाद विशेषताएं

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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.
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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 hygiene (see section 4.6),
it is crucial to follow the aseptic
technique of a