Ubro Red Dry Cow Intramammary Suspension

Country: Իռլանդիա

language: անգլերեն

source: HPRA (Health Products Regulatory Authority)

active_ingredient:

Penethamate hydriodide, Procaine benzylpenicillin, Framycetin sulphate

MAH:

Boehringer Ingelheim Ltd

ATC_code:

QJ51RC

INN:

Penethamate hydriodide, Procaine benzylpenicillin, Framycetin sulphate

dosage:

100/300/100 mg/5ml

pharmaceutical_form:

Intramammary suspension

prescription_type:

POM: Prescription Only Medicine as defined in relevant national legislation

therapeutic_group:

Cattle

therapeutic_area:

Beta-lactam antibacterials, penicillins, combinations with other antibacterials

therapeutic_indication:

Antibacterial

authorization_status:

Authorised

authorization_date:

2006-02-10

SPC

Health Products Regulatory Authority
20 March 2018
CRN000XW0
Page 1 of 5
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Ubro Red Dry Cow Intramammary Suspension
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5ml dose unit contains the following active ingredients:
Penethamate Hydriodide
100.0
mg
Procaine Benzylpenicillin
300.0
mg
Framycetin Sulphate
100.0
mg
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Intramammary suspension.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Bovine
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For routine use in cows to treat existing intramammary infections at
drying off and to
assist in preventing new infections occurring during the dry period.
_In vitro_ efficacy has been demonstrated against the following
organisms:
Staphylococcus spp.
Streptococcus spp.
Cornynebacteria spp.
_Escherichia coli_
Klebsiella spp.
Pseudomonas spp.
Health Products Regulatory Authority
20 March 2018
CRN000XW0
Page 2 of 5
4.3 CONTRAINDICATIONS
Do not administer to animals with known sensitivity to the active
ingredients.
Do not use in the lactating cow.
Not intended for use within 28 days of calving.
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
Before infusion, the teats should be thoroughly cleansed and
disinfected and care
should be taken to avoid contamination of the injector nozzle.
Following infusion it is advisable to use a teat dip or spray.
SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE
VETERINARY
MEDICINAL PRODUCT TO ANIMALS
Penicillin and cephalosporins may cause hypersensitivity (allergy)
following injection,
inhalation, ingestion or skin contact. Hypersensitivity to penicillin
may lead to cross
sensitivity to cephalosporins and vice versa. Allergic reaction to
these substances
may occasionally be serious.
1.Do not handle this product if you know you are sensitise