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Date: Tuesday, April 16, 2024 14:10

Release 2.81
Noroclox DC 500 mg Intramammary Suspension
 
Species: Cattle
Therapeutic indication: Pharmaceuticals: Antimicrobials: Intramammaries: Dry cow
Active ingredient: Cloxacillin Benzathine
Product:Noroclox DC 500 mg Intramammary Suspension
Product index: Noroclox DC
Cattle - milk: 108 hours
Cattle - meat: 28 days
Withdrawal notes: See datasheet
Incorporating:
Qualitative and quantitative composition
Each 4.5g syringe contains:
Active substance(s):
Cloxacillin (as Cloxacillin benzathine)
500 mg
Excipients:
For a full list of excipients, see section Pharmaceutical Particulars
Pharmaceutical form
Intramammary Suspension.
An off-white Intramammary Suspension.
Clinical particulars
Target species
Cattle, dairy cows
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.
Contraindications
Do not use in animals with known hypersensitivity to the active ingredient.
Special Warnings for each target species
None.
Special precautions for use
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.
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 reactions to these substances may occasionally be serious.
Do not handle this product if you know you are sensitised, or if you have been advised not to work with such preparations.
Handle this product with great care to avoid exposure, taking all recommended precautions.
If you develop symptoms following exposure such as skin rash, you should seek medical advice and show the doctor this warning. Swelling of the face, lips or eyes or difficulty breathing, are more serious symptoms and require urgent medical attention.
Wash hands after use.
Adverse reactions (frequency and seriousness)
None known.
Use during pregnancy, lactation or lay
Can be safely administered during pregnancy.
Interaction with other medicinal products and other forms of interaction
None known.
Amounts to be administered and administration route
The contents of one intramammary syringe should be gently infused into each quarter immediately after the final milking of a lactation.
Overdose (symptoms, emergency procedures, antidotes), if necessary
Not applicable.
Withdrawal period
Meat and Offal: 28 days
Not intended for use within 35 days of calving.
Milk for human consumption may only be taken from 108 hours after calving. Should a cow calve earlier than 35 days after the last treatment, milk for human consumption may only be taken from 35 days plus 108 hours after the last treatment.
In cows suffering from hypocalcaemia it may be necessary to withhold milk for a longer period than that stated above. In such cases, milk should be withheld until the levels of antibiotics are below the maximum accepted residue levels, i.e. 0.03 mcg/ml. for cloxacillin.
The product must not be used in the treatment of lactating cows.
Pharmacological particulars
Pharmacotherapeutic group: Antibiotic
ATC Vet Code: QJ51CF02
Pharmacodynamic properties
Cloxacillin is a member of the Beta-lactam group and is active against penicillin G resistant staphylococci. It binds to membrane bound proteins known as PBP's (Penicillin-binding proteins) that are located beneath the cell wall, thereby disrupting cell walls synthesis. Cloxacillin is bactericidal.
Pharmaceutical particulars
List of excipients
Aluminium Stearate
Liquid Paraffin
Incompatibilities
None known
Shelf life
Shelf life of the veterinary medicinal product as packaged for sale: 3 years
Special precautions for storage
Do not store above 25°C.
The syringe may only be used once. Part used syringes must be discarded.
Nature and composition of immediate packaging
4.5 g white pre-filled Intramammary syringes with low density polyethylene barrels and white or orange plungers closed with low density polyethylene white or orange end caps.
Available in cartons of 24 or 120 syringes, or buckets of 120 syringes.
Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.
Marketing Authorisation Holder (if different from distributor)
Norbrook Laboratories Limited, Station Works, Camlough Road, Newry, Co. Down, BT35 6JP Northern Ireland
Marketing Authorisation Number
Vm 02000/4040
Significant changes
Date of the first authorisation or date of renewal
21 November 1979
Date of revision of the text
August 2011
Any other information
Nil.
Legal category
Legal category: POM-V
GTIN
GTIN description:Noroclox DC (4.5g)
GTIN:5023534003878
GTIN description:Noroclox DC 4.5g
GTIN:5023534003885