Introduction

Pfizer

Company name: Pfizer Limited

Address: Ramsgate Road

Sandwich

Kent CT13 9NJ

Telephone: 0845 300 8034 (Out of hours: 01304 616161)

Fax: 01737 332521

Email: UKVetLine@pfizer.com

Website: www.only4vets.co.uk

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.

Keep out of reach of children.

For animal treatment only.

Each syringe may only be used once. Part used syringes must be disposed of.

Dispose of any unused product and empty containers in accordance with guidance from your local waste regulation authority.

Legal category

POM-V

Packaging Quantities

Cartons containing 24 syringes. An economy pack containing 120 syringes is also available.

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.