Item Number: LACTACLOX
Lactaclox is specially formulated for the broad-spectrum treatment of clinical mastitis in the lactating cow.
Lactaclox is effective against Gram-positive and Gram-negative bacteria including Streptococcus agalactiae, Streptococcus dysgalactiae and other streptococcal species; penicillin resistant and penicillin sensitive staphylococci; Arcanobacterium pyogenes; Escherichia coli and other Gram-negative bacteria.
Lactaclox is bactericidal at the concentrations produced and is non-irritant in the udder tissue.
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE VETERINARY MEDICINAL PRODUCT Lactaclox Intramammary Infusion
2. QUALITATIVE AND QUANTITATIVE COMPOSITION Active Substance Per 5g Syringe Ampicillin 75 mg (as ampicillin sodium) Cloxacillin 200 mg (as cloxacillin sodium). Excipients For a full list of excipients, see section 6.1
3. PHARMACEUTICAL FORM Intramammary Infusion An off-white suspension
4. CLINICAL PARTICULARS
4.1 Target species Cows
4.2 Indications for use, specifying the target species For the treatment of clinical bovine mastitis in the lactating cow caused by Gram-positive and Gram-negative bacteria including: Streptococcus agalactiae Streptococcus dysgalactiae Other Streptococcal spp Staphylococcus spp Arcanobacterium pyogenes Escherichia coli
4.3 Contraindications None Revised: July 2010 ATCVet code amended 2
4.4 Special Warnings for Each Target Species Before infusion, the quarter should be milked out completely, the teat should be thoroughly cleaned and disinfected and care should be taken to avoid contamination of the injector nozzle. Following infusion, massage the product up into the udder, and then it is advisable to use a teat dip or spray.
4.5 Special Precautions for Use i. Special Precautions for use in animals There are no special precautions for use in animals. ii. Special precautions to be taken by the person administering the product to the animals: 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. 1. Do not handle this product if you know you are sensitised, or if you have been advised not to work with such preparations. 2. Handle this product with great care to avoid exposure, taking all recommended precautions. 3. 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. Protective gloves should always be worn when infusing heifers, to avoid contact with the product. Wash hands after use.
4.6 Adverse reactions (frequency and seriousness) No known undesirable effects.
4.7 Use during pregnancy, lactation or lay Lactaclox is specifically indicated for the treatment of clinical mastitis in lactating cows. It can be safely administered to pregnant animals. Revised: July 2010 ATCVet code amended 3
4.8 Interactions with other medicinal products and other forms of interaction None
4.9 Amount to be administered and administration route The contents of one syringe should be infused into each affected quarter via the teat canal immediately after milking, at 12 hour intervals for three consecutive milkings.
4.10 Overdose (symptoms, emergency procedures, antidotes) (if necessary) Not applicable
4.11 Withdrawal periods Milk for human consumption must not be taken from a cow during treatment. With cows milked twice daily, milk for human consumption may only be taken from 60 hours (i.e. at the 5th milking) after the last treatment. Where any other routine is followed, consult your veterinary surgeon. With other milking routines, the basis of a veterinary surgeon's advice should be that milk may be taken for human consumption only after the same period from the last treatment. For example with three times a day milking with a product administered twice per day, milk for human consumption may only be taken at the 8th milking. Animals must not be slaughtered for human consumption during treatment. Cattle may be slaughtered for human consumption only after 4 days from the last treatment.
5. PHARMACOLOGICAL PROPERTIES Pharmacotherapeutic group: Antibacterials for intramammary use, Betalactam antibacterials, penicillins, for intramammary use, Combinations of penicillins and / or beta-lactamase inhibitors ATCvet Code: QJ51CR50
5.1 Pharmacodynamic properties Ampicillin possesses antibacterial activity against Gram-positive and Gram-negative bacteria. Cloxacillin is active against Penicillin G resistant staphylococci. Both beta-lactam antibiotics bind membrane bound proteins known as penicillin-binding proteins (PBP's). Revised: July 2010 ATCVet code amended 4
6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients White Soft Paraffin Liquid Paraffin
6.2 Incompatibilities None Known
6.3 Shelf-life Shelf life of the veterinary medicinal product as packaged for sale: 2 years.
6.4 Special precautions for storage Do not store above 25ºC. The syringe may only be used once. Part used syringes must be discarded.
6.5 Nature and composition of immediate packaging 5g single dose white low density polyethylene syringe barrels and plunger, with white low density polyethylene cap. Available in cartons of 24 single use syringes
6.6 Special precautions for the disposal of unused veterinary medicinal products or waste materials derived from the use of such products, if appropriate Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.
7. MARKETING AUTHORISATION HOLDER Norbrook Laboratories Limited Station Works Camlough Road NEWRY Co. Down, BT35 6JP Northern Ireland
8. MARKETING AUTHORISATION NUMBER Vm 02000/4044 Revised: July 2010 ATCVet code amended 5
9. DATE OF FIRST AUTHORISATION 10th December 1979
10. DATE OF REVISION OF THE TEXT July 2010
Shipping charges mainland UK zone1
|Over £49.00||Any Weight||FREE|
|Under £49.00||No weight limit||£4.50|
|Under £49.00||Under 250g||£2.99|
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*Due to legal requirements medicines may not be returned except to correct an error in despatch or in response to an "official recall". If an item is believed to be faulty it should be returned for inspection and it may be necessary to forward it to the manufacturers for testing before replacements or refunds can be authorised. This does not infringe legal rights. Please contact our customer services for a "Returns Number" which must appear on the outside of the package or it will not be accepted. We advise customers to use an insured method of shipping and to retain proof of despatch. We may refuse returns on products specially obtained or manufactured to order. Items must be returned unsoiled and unused and sent adequately packed and carriage paid.
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