Synulox Lactating Cow Intramammary suspension.

Ülke: İrlanda

Dil: İngilizce

Kaynak: HPRA (Health Products Regulatory Authority)

Aktif bileşen:

Amoxicillin trihydrate; potassium clavulanate; Prednisolone

Mevcut itibaren:

Zoetis Belgium S.A.

ATC kodu:

QJ51RV01

INN (International Adı):

Amoxicillin trihydrate; potassium clavulanate; Prednisolone

Doz:

200, 50, 10 mg/syringe

Farmasötik formu:

Intramammary suspension

Reçete türü:

POM: Prescription Only Medicine as defined in relevant national legislation

Terapötik grubu:

Cattle

Terapötik alanı:

antibacterials and corticosteroids

Terapötik endikasyonlar:

Antibacterial

Yetkilendirme durumu:

Authorised

Yetkilendirme tarihi:

2014-11-28

Ürün özellikleri

1
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Synulox LC Intramammary suspension (BG, CY, CZ, ES, EL, HU, LT, LV,
PL, PT, RO, SI, SK)
Synulox Intramammary suspension (FR, IT)
Synulox Lactating Cow Intramammary suspension (IE/UK(NI))
Synulox Comp. Intramammary suspension (AT)
Synulox Comp. Vet. Intramammary suspension (NO)
Avuloxil Intramammary suspension (NL)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 3 g intramammary syringe contains:
ACTIVE SUBSTANCES:
Amoxicillin (as amoxicillin trihydrate)
200 mg
Clavulanic acid (as potassium clavulanate)
50 mg
Prednisolone
10 mg
EXCIPIENTS:
QUALITATIVE COMPOSITION OF EXCIPIENTS AND
OTHER CONSTITUENTS
Calcium Sodium Aluminosilicate (dried)
Emulsifying Wax
White Soft Paraffin
Light Liquid Paraffin
Pale cream/buff coloured oily intramammary suspension.
3.
CLINICAL INFORMATION
3.1
TARGET SPECIES
Cattle (lactating cows).
3.2
INDICATIONS FOR USE FOR EACH TARGET SPECIES
For use in clinical cases of mastitis including cases associated with
infections with the following
pathogens:
Staphylococci (including

-lactamase producing strains)
Streptococci (including
_S.agalactiae, S.dysgalactiae and S.uberis_
)
_Escherichia coli_
(including

-lactamase producing strains)
3.3
CONTRAINDICATIONS
Do not use in cases of hypersensitivity to the active substance or to
any of the excipients.
Do not use in animals which are known to be hypersensitive to

-lactamase antibiotics.
3.4
SPECIAL WARNINGS
2
Do not use in cases associated with
_Pseudomonas_
.
3.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for safe use in the target species:
Swab teat end with appropriate disinfectant before treatment.
RECOMMENDATIONS FOR PRUDENT USE
The product should be used for treatment of clinical mastitis only.
Use of the product should be based on local (regional, farm level)
epidemiological information about
susceptibility of the target bacteria and take into account official
and local antimicrobial policies.
The use of the product should preferably be based on susceptibility
tests.
Avoid use of t