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Date: Sunday, May 26, 2024 21:38

Release 2.90
Bovaclox DC Xtra Intramammary Suspension
 
Species: Cattle
Therapeutic indication: Pharmaceuticals: Antimicrobials: Intramammaries: Dry cow
Active ingredient: Ampicillin, Cloxacillin Benzathine
Product:Bovaclox DC Xtra Intramammary Suspension
Product index: Bovaclox DC Xtra
Cattle - milk: 156 hours after calving. See notes
Cattle - meat: 28 days
Withdrawal notes: See datasheet - must not be used in treatment of lactating cows. Not intended for use in within 49 days of calving.
Incorporating:
Qualitative and quantitative composition
Each 5.4g product contains:
Active Substance:
mg
Cloxacillin (as Cloxacillin benzathine)
600
Ampicillin (as Ampicillin trihydrate)
300
Excipients:
For a full list of excipients, see section Pharmaceutical Particulars
Pharmaceutical form
Intramammary suspension.
An oily off white suspension.
Clinical particulars
Target species
Cattle
Indications for use, specifying the target species
Formulated for use in the dairy cow 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.
A useful aid in reducing the incidence of summer mastitis in heifers and dry cows at risk.
Active against both Gram-positive and Gram-negative organisms which are associated with mastitis and is effective against Streptococcus agalactiae and other Streptococcus species, penicillin resistant and sensitive Staphylococci, Corynebacterium, Arcanobacteria species, Escherichia coli and other susceptible Gram- negative bacteria.
Cloxacillin benzathine and ampicillin trihydrate in a long-acting base maintain effective antibacterial levels in the dry cow udder for up to 10 weeks and are non-irritant to udder tissue.
Contraindications
None.
Special Warnings for each target species
None known.
Special precautions for use
Special precautions for use in animals
When infusing heifers it is important that the syringe nozzle is not introduced into the teat. The recommended procedure is as follows:
The animal(s) should be properly restrained. The teats are cleaned and disinfected. The teat orifice is located and the nozzle of the syringe placed against it but NOT inserted. When the syringe plunger is depressed the antibiotic passes easily through the teat into the udder.
Official national and regional antimicrobial policies should be taken into account when the product is used.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
Protective gloves should always be worn when infusing heifers, 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.
Sensitised individuals or those advised not to work with such preparations should not handle this product.
This product should be handled with great care to avoid exposure, taking all recommended precautions.
Should symptoms develop following exposure such as skin rash, medical advice should be sought. Swelling of the face, lips or eyes or difficulty with 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
Safe for use during pregnancy.
Interaction with other medicinal products and other forms of interaction
None known.
Amounts to be administered and administration route
Dry Off Therapy: After the final milking of a lactation, clean and disinfect the teats and introduce the contents of one tube into each quarter via the teat canal. Avoid contamination of the syringe nozzle.
When infusing heifers it is important that the syringe nozzle is not introduced into the teat. The recommended procedure is as follows:
The animal(s) should be properly restrained. The teats are cleaned and disinfected. The teat orifice is located and the nozzle of the syringe placed against it but NOT inserted. When the syringe plunger is depressed the antibiotic passes easily through the teat into the udder.
Overdose (symptoms, emergency procedures, antidotes), if necessary
Not applicable.
Withdrawal period
Do not use in cows with a short dry period.
Not intended for use within 49 days of calving.
Milk for human consumption may only be taken from 156 hours after calving.
Should a cow calve earlier than 49 days after the last treatment, milk for human consumption may only be taken from 49 days plus 156 hours after the last treatment. Should a cow calve earlier than 49 days after treatment, consult your veterinary surgeon.
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 and 0.004 mcg/ml ampicillin.
Animals must not be slaughtered for human consumption during treatment. Cattle may be slaughtered for human consumption only 28 days from the last treatment.
The product must not be used in the treatment of lactating cows. Should this occur milk should be discarded for 30 days, following which time milk should be tested until antibiotic can no longer be detected.
Must not be used in the treatment of lactating cows.
Pharmacological particulars
Pharmacotherapeutic group: Antibacterials for intramammary use, Beta-lactam antibacterials, penicillins, for intramammary use, Combinations of penicillins and / or beta-lactamase inhibitors.
ATC Vet Code: QJ51CR50
Pharmacodynamic properties
Contains ampicillin and cloxacillin, which are both beta-lactam antibiotics. Their structures containing the same beta-lactam ring and thiazolidine ring common to all penicillins.
Beta-lactam antibiotics prevent the bacterial cell wall from forming by interfering with the final stage of peptidoglycan synthesis. They inhibit the activity of transpeptidase enzymes, which catalyse cross-linkage of the glycopeptide polymer units that form the cell wall. They exert a bactericidal action but cause lysis only of growing cells. The difference in susceptibility between Gram-positive and Gram-negative bacteria depends on differences in receptor sites, on the relative amount of peptidoglycan present, on the ability of drugs to penetrate the outer cell membrane of Gram-negative bacteria and on resistance to the different types of beta-lactamase enzymes produced by the bacteria.
Ampicillin has a high activity against both Gram-positive and Gram-negative bacteria, but is inactivated by beta-lactamases.
Cloxacillin is relatively resistant to staphylococcal beta-lactamases but is of lower activity than penicillin G against susceptible Gram-positive bacteria and is inactive against Gram-negative bacteria.
The combination of penicillinase-resistant penicillins, such as cloxacillin, with ampicillin, against common opportunist Gram-negative bacteria, has shown synergism in many cases.
Pharmaceutical particulars
List of excipients
Aluminium Distearate
Liquid Paraffin
Incompatibilities
None known.
Shelf life
Shelf life of the veterinary medicinal product as packaged for sale: 2 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
These intramammary syringes will be supplied in outer cartons of 24 and 120 syringes.
5.4g pre-filled intramammary syringes with high density polyethylene barrels and white or red plungers, closed with high density polyethylene snap on, red or white caps.
Not all pack sizes may be marketed.
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 material derived from such a 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 02000/4111
Significant changes
Date of the first authorisation or date of renewal
11th April 1994
Date of revision of the text
July 2010
Any other information
Nil.
Legal category
Legal category: POM-V
GTIN
GTIN description:Bovaclox DC Xtra: 5.4g x 120
GTIN:5023534004004