Multishield DC Intramammary Suspension for Cows

Šalis: Airija

kalba: anglų

Šaltinis: HPRA (Health Products Regulatory Authority)

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Parsisiųsti Prekės savybės (SPC)
12-01-2018

Veiklioji medžiaga:

Neomycin ; Penethamate; Benzylpenicillin

Prieinama:

Cross Vetpharm Group Limited

ATC kodas:

QJ51RC

INN (Tarptautinis Pavadinimas):

Neomycin ; Penethamate; Benzylpenicillin

Dozė:

70000 IU, 77.2 mg, 227.2 mg per syringe

Vaisto forma:

Intramammary suspension

Recepto tipas:

POM: Prescription Only Medicine as defined in relevant national legislation

Farmakoterapinė grupė:

Cattle

Gydymo sritis:

Beta-lactam antibacterials, penicillins, combinations with other antibacterials

Terapinės indikacijos:

Antibacterial

Autorizacija statusas:

Authorised

Leidimo data:

2013-01-25

Prekės savybės

                                Health Products Regulatory Authority
11 January 2018
CRN000VGY
Page 1 of 6
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Multishield DC Intramammary Suspension for Cows
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 4.5g intramammary syringe contains
Active Substances:
Neomycin 70 000 IU
(corresponding to Neomycin Sulphate 100 mg)
Penethamate 77.2 mg
(corresponding to Penethamate Hydriodide 100 mg)
Benzylpenicillin 227.2 mg
(corresponding to Procaine Benzylpenicillin 400 mg)
Excipients:
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Intramammary suspension.
A smooth, off white, oily suspension.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Cows (at dry off)
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
In cows at drying off:
Treatment of subclinical mastitis caused by bovine mastitis
microorganisms
susceptible to the combination of active substances, penicillin and
neomycin, and as
part of strategy for the prevention of new infections occurring during
the dry period.
4.3 CONTRAINDICATIONS
Do not use in lactating cows.
Do not use in cases of hypersensitivity to β-lactam antibiotics,
cephalosporin
antibiotics, neomycin or other aminoglycoside antibiotics or to any of
the excipients.
Do not use in cows with clinical mastitis.
Health Products Regulatory Authority
11 January 2018
CRN000VGY
Page 2 of 6
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
4.5 SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
Use of the product should be based on susceptibility testing of the
bacteria isolated
from the animal. If this is not possible, therapy should be based on
local (regional,
farm level) epidemiological information about susceptibility of the
target bacteria.
Official, national and regional antimicrobial policies should be taken
into account
when the product is used.
The therapeutic efficacy of the product is only established against
pathogens that are
susceptible to the active substances.
Serious acute mastitis [potentially lethal] due to pathogens like
_Pseudomonas _
_aerugin
                                
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