Ubrostar Red 100 mg / 280 mg / 100 mg Intramammary Suspension for cattle

Šalis: Airija

kalba: anglų

Šaltinis: HPRA (Health Products Regulatory Authority)

Veiklioji medžiaga:

Penethamate hydriodide ; Benethamine penicillin ; Framycetin sulphate

Prieinama:

Boehringer Ingelheim Vetmedica GmbH

ATC kodas:

QJ51RC25

INN (Tarptautinis Pavadinimas):

Penethamate hydriodide ; Benethamine penicillin ; Framycetin sulphate

Dozė:

100, 280, 100 mg/syringe

Vaisto forma:

Intramammary suspension

Recepto tipas:

POM: Prescription Only Medicine as defined in relevant national legislation

Farmakoterapinė grupė:

Cattle

Gydymo sritis:

penethamate hydroiodide, combinations with other antibacterials

Terapinės indikacijos:

Antibacterial

Autorizacija statusas:

Authorised

Leidimo data:

2012-11-23

Prekės savybės

Health Products Regulatory Authority
26 April 2018
CRN000X0N
Page 1 of 5
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Ubrostar Red 100 mg / 280 mg / 100 mg Intramammary Suspension for
cattle
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 4.5 g intramammary syringe contains:
ACTIVE SUBSTANCES:
Penethamate Hydriodide 100 mg (equivalent to 77.2 mg penethamate)
Benethamine Penicillin 280 mg (equivalent to 171.6 mg penicillin)
Framycetin Sulphate 100 mg (equivalent to 71.0 mg framycetin)
EXCIPIENTS:
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Intramammary suspension.
White to off white suspension.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Cattle (at drying off)
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For treatment of subclinical mastitis at drying off, and the
prevention of new bacterial
infections of the udder during the dry period in dairy cows, caused by
bacteria
susceptible to penicillin and framycetin.
4.3 CONTRAINDICATIONS
Do not use in lactating cows.
Do not use in case of hypersensitivity to the active substances or to
any of the
excipients.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
Where there is a risk of summer mastitis, additional management
procedures, such
as fly control should be considered.
Health Products Regulatory Authority
26 April 2018
CRN000X0N
Page 2 of 5
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 and
local antimicrobial policies should be taken into account when the
product is used.
Serious acute mastitis [potentially lethal] due to pathogens like
_Pseudomonas _
_aeruginosa_, can occur after drying off despite preventive treatment.
Good aseptic
practices should be thoroughly respected in order to reduce that risk;
cows should
be housed in a hygienic paddock far