Noroclox DC 500 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:

1979-11-21

Summary of Product characteristics

Revised: August 2011
AN: 00406/2004
Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Noroclox DC 500mg Intramammary Suspension
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE SUBSTANCE:
Each 4.5g syringe contains 500 mg cloxacillin (as Cloxacillin
benzathine)
EXCIPIENTS:
For a full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Intramammary Suspension
An off-white Intramammary Suspension
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Cattle, dairy cows
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For routine use in cows at drying-off to treat existing intramammary
infections
and to assist in preventing new infections occurring during the dry
period. It is
effective against;
_Streptococcus agalactiae_
_Streptococcus dysgalactiae_
Other Streptococcal spp
Staphylococci spp
_Arcanobacterium pyogenes_
The product maintains effective antibacterial levels in the dry cow
udder for
approximately 4 weeks and is bactericidal in action.
4.3
CONTRAINDICATIONS
Do not use in animals with known hypersensitivity to the active
ingredient.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
None
Revised: August 2011
AN: 00406/2004
Page 2 of 4
4.5
SPECIAL PRECAUTIONS FOR USE
i.
Special precautions for use in animals
Official national and regional antimicrobial policies should be taken
into
account when the product is used.
Before infusion, the teat should be thoroughly cleaned and disinfected
and care should be taken to avoid contamination of the injector
nozzle.
Following infusion, it is advisable to use a teat dip or spray.
ii.
Special precautions to be taken by the person administering the
veterinary medicinal product to animals
When infusing heifers, protective gloves should always be worn in
order to avoid skin contact with the product.
Penicillins and cephalosporins may cause hypersensitivity (allergy)
following injection, inhalation, ingestion, or skin contact.
Hypersensitivity to penicillins may lead to cross-reactions to
cephalosporins and vice versa. Allergic reaction