Noroclox DC Xtra 600 mg Intramammary Suspension

Country: United Kingdom

Language: English

Source: VMD (Veterinary Medicines Directorate)

Active ingredient:

Cloxacillin

Available from:

Norbrook Laboratories Limited

ATC code:

QJ51CF02

INN (International Name):

Cloxacillin

Pharmaceutical form:

Intramammary suspension

Prescription type:

POM-V - Prescription Only Medicine – Veterinarian

Therapeutic group:

Cattle

Therapeutic area:

Antimicrobial intramammary

Authorization status:

Authorized

Authorization date:

1995-03-10

Summary of Product characteristics

Revised: July 2018
AN: 02259/2017
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Noroclox DC Xtra 600mg Intramammary Suspension
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE SUBSTANCE:
Each 5.4 g syringe contains:
Cloxacillin
600 mg
(as benzathine salt)
For the full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Intramammary suspension
An oily off white suspension
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Dairy cows and heifers
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
The product 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.
The product is a useful aid in reducing the incidence of summer
mastitis in dry cows
at risk.
Cloxacillin is active against Gram-positive organisms which are
associated with
mastitis. These include _ Streptococcus agalactiae_ and other _
Streptococcus_ species,
penicillin resistant and sensitive Staphylococci and _Arcanobacterium
pyogenes_.
The
product
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 and is
non-irritant to udder tissue.
4.3
CONTRAINDICATIONS
Do not use in cases of hypersensitivity to the active substances or to
any of the
excipients.
Revised: July 2018
AN: 02259/2017
Page 2 of 5
Animals must not be slaughtered for human consumption during
treatment. Cattle
may
be
slaughtered
for
human
consumption
only
after
28
days
from
the
last
treatment.
The product must not be used in lactating cows. Should this occur,
milk should be
discarded for 24 days, following which time milk should be tested
until the levels of
antibiotic are below the maximum acceptable residue limit i.e., 0.03
mcg/ml for
cloxacillin.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
When infusing heifers it is important that the syringe nozzle is not
introduced into the