Ceffect LC, 75 mg, Intramammary Ointment for Lactating Cows

Country: Велика Британија

Језик: Енглески

Извор: VMD (Veterinary Medicines Directorate)

Активни састојак:

Cefquinome

Доступно од:

Emdoka bvba

АТЦ код:

QJ51DE90

INN (Међународно име):

Cefquinome

Фармацеутски облик:

Intramammary ointment

Тип рецептора:

POM-V - Prescription Only Medicine – Veterinarian

Терапеутска група:

Cattle

Терапеутска област:

Antimicrobial intramammary

Статус ауторизације:

Authorized

Датум одобрења:

2014-05-08

Карактеристике производа

Revised: July 2019
AN: 00746/2018
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Ceffect LC, 75 mg, intramammary ointment for lactating cows
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION:
Each prefilled intramammary syringe of 8 g contains:
ACTIVE SUBSTANCE:
Cefquinome 75 mg
(Equivalent to Cefquinome sulfate 88.92 mg)
EXCIPIENTS:
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Intramammary ointment.
White to slightly yellowish ointment.
4. CLINICAL PARTICULARS
4.1. TARGET SPECIES
Cattle (lactating cows).
4.2. INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the treatment of clinical mastitis in the lactating dairy cow
caused by the
following
cefquinome-susceptible
microorganisms:
_Streptococcus _
_uberis, _
_Streptococcus dysgalactiae, Staphylococcus aureus_ and_ Escherichia
coli_.
4.3 CONTRAINDICATIONS
Do not use in cases of hypersensitivity to cephalosporin antibiotics,
other ß-
lactam antibiotics or to any of the excipients.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
4.5 SPECIAL PRECAUTIONS FOR USE
_Special precautions for use in animals_
Revised: July 2019
AN: 00746/2018
Page 2 of 5
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.
The feeding to calves of milk containin