Cefquinome Norbrook LC, 75 mg Intramammary Ointment for Lactating Cows

Ülke: İrlanda

Dil: İngilizce

Kaynak: HPRA (Health Products Regulatory Authority)

Aktif bileşen:

Cefquinome

Mevcut itibaren:

Norbrook Laboratories Limited

ATC kodu:

QJ51DE90

INN (International Adı):

Cefquinome

Doz:

75 mg/syringe

Farmasötik formu:

Intramammary ointment

Reçete türü:

POM: Prescription Only Medicine as defined in relevant national legislation

Terapötik grubu:

Bovine

Terapötik alanı:

cefquinome

Terapötik endikasyonlar:

Antibacterial

Yetkilendirme durumu:

Authorised

Yetkilendirme tarihi:

2014-09-12

Ürün özellikleri

Health Products Regulatory Authority
26 November 2018
CRN008QQ1
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Cefquinome Norbrook LC, 75 mg Intramammary Ointment for Lactating Cows
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each pre-filled syringe of 8 g contains:
ACTIVE SUBSTANCE:
Cefquinome 75 mg
(as Cefquinome Sulfate)
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Intramammary ointment.
A homogeneous off-white oily ointment.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Cattle (Lactating cow).
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the treatment of clinical mastitis in the lactating cow caused by
bacteria
susceptible to cefquinome, namely _Staphylococcus aureus,
Streptococcus uberis, _
_Streptococcus dysgalactiae, Escherichia coli_.
4.3 CONTRAINDICATIONS
Do not use in case of hypersensitivity to cephalosporin antibiotics or
other β-lactam
antibiotics, or to any of the excipients.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
Health Products Regulatory Authority
26 November 2018
CRN008QQ1
Page 2 of 5
4.5 SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
The product should be reserved for the treatment of clinical
conditions which have
responded poorly, or are expected to respond poorly, to other classes
of
antimicrobials or narrow spectrum β-lactam antimicrobials.
Use of the product should be based on susceptibility testing of the
bacteria isolated
from the animal. If it 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.
Use of the product deviating from the instructions given in the SPC
may increase the
prevalence of bacteria resistant to cefquinome and may decrease the
effectiveness of
treatment with cephalosporins, due to the potential for
cross-resistance.
Do not use the cleaning towel on teats wit