Ubrostar Red 100 mg / 280 mg / 100 mg, Intramammary Suspension for Cattle

Country: United Kingdom

Language: English

Source: VMD (Veterinary Medicines Directorate)

Active ingredient:

Benethamine Penicillin, Framycetin Sulphate, Penethamate hydriodide, non-micronised

Available from:

Boehringer Ingelheim Limited

ATC code:

QJ51RC25

INN (International Name):

Benethamine Penicillin, Framycetin Sulphate, Penethamate hydriodide, non-micronised

Pharmaceutical form:

Intramammary suspension

Prescription type:

POM-V - Prescription Only Medicine – Veterinarian

Therapeutic group:

Cattle

Therapeutic area:

Antimicrobial

Authorization status:

Authorized

Authorization date:

2011-12-13

Summary of Product characteristics

Revised: May 2018
AN: 01982/2017
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
UK, IE
Ubrostar Red 100 mg / 280 mg / 100 mg, Intramammary Suspension for
cattle
FR
Ubrostar SUSPENSION INTRAMAMMAIRE HORS LACTATION POUR BOVINS
BG, BE, CZ, HU, NL PL, RO, SK, SI
Ubrostar DC 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.
Page 1 of 5
Revised: May 2018
AN: 01982/2017
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.
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 prev