Noroclav Intramammary Suspension for Lactating Cows

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Amoxicillin trihydrate; potassium clavulanate; Prednisolone

Available from:

Norbrook Laboratories (Ireland) Limited

ATC code:

QJ51RV01

INN (International Name):

Amoxicillin trihydrate; potassium clavulanate; Prednisolone

Dosage:

200, 50, 10 mg/syringe

Pharmaceutical form:

Intramammary suspension

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic area:

antibacterials and corticosteroids

Authorization status:

Authorised

Authorization date:

2018-11-30

Summary of Product characteristics

Health Products Regulatory Authority
07 October 2020
CRN009Z9T
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Noroclav Intramammary Suspension for Lactating Cows
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each intramammary syringe of 3g contains:
​
ACTIVE SUBSTANCES:
​
​
Amoxicillin (as amoxicillin trihydrate)
​200 mg
​
Clavulanic acid (as potassium clavulanate)
​50 mg
​
Prednisolone
​10 mg
EXCIPIENTS:
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Intramammary suspension
Cream to buff oily suspension
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 caused by the following
bacteria susceptible to the combination of amoxicillin and
clavulanic acid:
Staphylococci (including β-lactamase producing strains)
Streptococci (including _S. agalactiae, S. dysgalactiae_ and _S.
uberis_)
_Escherichia coli _(including β-lactamase producing strains)
4.3 CONTRAINDICATIONS
Do not use in cases of hypersensitivity to the active substances, or
to any of the excipients.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
Do not use in cases associated with _Pseudomonas._
4.5 SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
Swab teat end before treatment, with cleaning towels provided.
RECOMMENDATIONS FOR PRUDENT USE
The product should be used for treatment of clinical mastitis only.
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, national and regional antimicrobial policies should be taken
into account when the product is used.
Health Products Regulatory Authority
07 October 2020
CRN009Z9T
Page 2 of 5
The combination of amoxicillin and clavulanic acid should be reserved
for the treatment of clinical conditions whic