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Date: Thursday, May 30, 2024 3:17

Release 2.18
Orbenin Dry Cow 500 mg Intramammary Suspension
 
Species: Cattle
Therapeutic indication: Pharmaceuticals: Antimicrobials: Intramammaries: Dry cow
Active ingredient: Cloxacillin Benzathine
Product:Orbenin® Dry Cow
Product index: Orbenin Dry Cow
Cattle - milk: 204 hours (30 days)
Cattle - meat: 28 days
Incorporating:
Presentation
Orbenin Dry Cow is an off-white suspension of cloxacillin as the benzathine salt in a long acting base with 3% aluminium stearate. It is presented in syringes containing 500 mg cloxacillin in 3 g of suspension.
Uses
To treat existing mastitis infections and to provide protection against further infections during the dry period.
Orbenin is active against Gram-positive organisms associated with mastitis. It is effective against Streptococcus agalactiae and other streptococcal species, penicillin-resistant and sensitive staphylococci and Actinomyces pyogenes. Orbenin is not destroyed by staphylococcal penicillinase. It is therefore active against penicillin-resistant staphylococci which are an important cause of mastitis.
Dosage and administration
Dosage
One syringe per quarter immediately after the final milking of lactation.
Administration
At drying off clean and disinfect the teat end thoroughly with surgical spirit following the last milking. Insert nozzle into the teat and apply gentle and continuous pressure until the suspension is expressed. After infusion it is advisable to dip each teat in an authorised teat dip.
Contra-indications, warnings, etc
Do not use in the lactating cow. If lactating cows are accidentally infused, milk should be withheld from the bulk supply for 30 days or less time if testing shows cloxacillin residues below the MRL of 0.03 mcg/ml.
Withdrawal periods
Not intended for use within 30 days of calving. Milk for human consumption may only be taken from 204 hours after calving. If calving occurs before 30 days after last treatment, milk for human consumption may only be taken after 30 days plus 204 hours after the last treatment.
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.
Operator warnings
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 a skin rash, you should seek medical advice and show the doctor this warning. Swelling of the face, lips or eyes or difficulty with breathing, are more serious symptoms and require urgent medical attention.
Wash hands after use.
Pharmaceutical precautions
Do not store above 25°C.
Each syringe must only be used once. Part used syringes must be disposed of.
Unused product and containers should be disposed of in accordance with any guidance from an appropriate waste regulation authority.
Keep out of the sight and reach of children.
For animal treatment only.
Further information
The benzathine salt of cloxacillin in the long acting aluminium stearate base maintains effective antibacterial levels in the mammary gland of dry cows for approximately three to four weeks. The antibiotic is bactericidal and it is non-irritant to the udder tissues.
Legal category
Legal category: POM-V
Packaging quantities
Cartons of 24 and 120 syringes. Not all pack sizes may be marketed.
Marketing Authorisation Number
Vm 42058/4088
Significant changes
GTIN
GTIN description:24 syringes:
GTIN:05013457076790
GTIN description:120 syringes:
GTIN:05013457076806