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Date: Thursday, April 25, 2024 22:55

Release 2.18
Orbenin Extra Dry Cow 600 mg Intramammary Suspension
 
Species: Cattle
Therapeutic indication: Pharmaceuticals: Antimicrobials: Intramammaries: Dry cow
Active ingredient: Cloxacillin Benzathine
Product:Orbenin® Extra Dry Cow
Product index: Orbenin Extra Dry Cow
Cattle - milk: 96 hours (42 days)
Cattle - meat: 28 days
Incorporating:
Presentation
Orbenin Extra Dry Cow is an off-white stable suspension of cloxacillin as the benzathine salt in a long-acting mineral oil base, prepared under sterile conditions. It is presented in syringes containing 600 mg cloxacillin as the benzathine salt, in 3.6 g of suspension.
Uses
Orbenin Extra Dry Cow is recommended for routine use in cows at drying off, to treat existing intramammary infections and to provide prolonged protection against new infections during the dry period. The concomitant use of Orbeseal™ at drying off provides additional protection against the ingress of udder pathogens, contributing to preventing both subclinical infections and clinical mastitis during early lactation.
Orbenin is active against Gram-positive organisms associated with mastitis. These include: Streptococcus agalactiae, Streptococcus dysgalactiae, Streptococcus uberis, penicillin-resistant and sensitive staphylococci, and Actinomyces pyogenes. Orbenin is bactericidal in action and is not destroyed by staphylococcal beta-lactamase. 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 a lactation.
Administration
At drying off clean and disinfect the teat end thoroughly with surgical spirit following the last milking. Insert nozzle into teat and apply gentle and continuous pressure until suspension is expressed. After infusion it is advisable to dip each teat in a licensed 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 46 days or less time if testing shows cloxacillin residues below the MRL of 0.03 mcg/ml.
Withdrawal periods
The following applies to the use of Orbenin Extra Dry Cow either alone or in combination with Orbeseal. Not intended for use in cows with dry periods of 42 days or less. Milk for human consumption may only be taken from 96 hours after calving. If calving occurs before 42 days after the last treatment, milk for human consumption may only be taken from 42 days plus 96 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 may only be used once. Part used syringes must be disposed of.
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.
Keep out of the sight and reach of children.
For animal treatment only.
Legal category
Legal category: POM-V
Packaging quantities
Cartons containing 24 syringes. An economy pack containing 120 syringes is also available. Not all pack sizes may be marketed.
Further information
Orbenin Extra Dry Cow formulation is non-irritant to udder tissues and maintains effective antibiotic levels in the majority of quarters for at least 7 weeks after infusion. It thus provides an extended period of protection against new infection.
Marketing Authorisation Number
Vm 42058/4089
Significant changes
GTIN
GTIN description:24 syringes:
GTIN:05013457076813
GTIN description:120 syringes:
GTIN:05013457076820