NOROCLOX DC XTRA INTRAMAMMARY SUSPENSION
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
17-07-2015
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Active ingredient:
CLOXACILLIN
Available from:
Norbrook Laboratories Limited
ATC code:
QJ51CF02
INN (International Name):
CLOXACILLIN
Dosage:
600 mg/syringe
Pharmaceutical form:
intramammary Suspension
Prescription type:
POM
Therapeutic group:
Bovine
Therapeutic area:
Cloxacillin
Therapeutic indications:
Antibacterial
Authorization status:
Authorised
Authorization date:
1996-05-15
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Noroclox DC Xtra Intramammary Suspension.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Active Substance
Cloxacillin Benzathine (1% lecithin coated) equivalent to cloxacillin 11.11%w/w
each 5.4 g syringe contains 600 mg cloxacillin
For a full list of excipients, see Section 6.1
3 PHARMACEUTICAL FORM
Intramammary suspension.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Dairy cows and heifers.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Noroclox DC Xtra is formulated for use in cows at the point of drying off, that is, immediately after the last milking of
the lactation in order to treat existing mastitis and to provide protection against further infections during the dry period.
Noroclox DC Xtra is a useful aid in reducing the incidence of summer mastitis in dry cows at risk.
Noroclox DC Xtra is active against Gram-positive organisms which are associated with mastitis. These include
_Streptococcus agalactiae _and other _Streptococcus _species, penicillin resistant and sensitive Staphylococci,
_Corynebacterium pyogenes_.
Noroclox DC Xtra is formulated with a long-acting base and maintains effective antibacterial levels in the majority of
quarters in dry cows for at least 7 weeks.
4.3 CONTRAINDICATIONS
Do not use on cows which have a short dry period. Not intended for use within 42 days of calving.
Animals must not be slaughtered for human consumption during treatment.
Do not use in the treatment of lactating cows. Should this occur, milk should be discarded for 42 days, following
which time milk should be tested until the levels of antibiotic are below the EU maximum residue limit of 30 µg/kg for
cloxacillin.
Do not use in animals with known hypersensitivity to the active ingredient.
4.4 SP
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