Orbenin LA
Active substance
ATC code
Species
Cattle and sheep.
Indications
Orbenin L.A. is indicated for intramammary use in the treatment of bovine mastitis caused by Gram-positive organisms. For the best results it should be used at the earliest signs of infection.
The product is also indicated as an intramammary infusion in ewes at weaning for the treatment and prevention of mastitis. Orbenin is effective against Streptococcus agalactiae and other streptococcal species, penicillin-resistant and sensitive staphylococci and Actinomyces pyogenes.
In staphylococcal and certain forms of streptococcal mastitis, an adequate duration of treatment is important in achieving both clinical and bacteriological cures. Orbenin L.A. with its slow release characteristics is designed to meet these requirements.
Dose to be administered and administration route
Cows
Dosage
The recommended dose is three infusions per infected quarter - one syringe administered every 48 hours.
Dosing guide
Clean and disinfect the teat with surgical spirit after milking; insert nozzle into the teat and apply gentle and continuous pressure until the suspension is expressed. The treated quarter(s) may be milked out at the next normal milking time.
Ewes
Dosage
A single infusion should be made into each udder half at weaning.
Administration
It is important that a simple hygienic procedure is followed. One operator should turn up and hold each ewe whilst a second person carries out the infusion technique. Clean and disinfect each teat end thoroughly with surgical spirit. Appose the syringe nozzle to the teat orifice and apply gentle, continuous pressure to express the suspension in the udder.
Actual cannulation of the teat orifice is neither necessary nor desirable.
Use a fresh syringe for each udder half to avoid the possibility of cross contamination during infusion.
Adverse reactions
None.
Dispensing
POM-V - Prescription Only Medicine – VeterinarianSUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE VETERINARY MEDICINAL PRODUCT
Orbenin L.A. 200 mg Intramammary Suspension
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 3 g dose unit contains the following:
Active ingredient
Cloxacillin as cloxacillin sodium Other ingredients |
200 mg |
Vegetable oil base to |
3 g |
For the full list of all other excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Intramammary suspension.
4. CLINICAL PARTICULARS
4.1 Target species
Cattle and sheep.
4.2 Indications for use, specifying the target species
Orbenin L.A. is indicated for intramammary use in the treatment of bovine mastitis caused by Gram-positive organisms. For the best results it should be used at the earliest signs of infection.
The product is also indicated as an intramammary infusion in ewes at weaning for the treatment and prevention of mastitis. Orbenin is effective against Streptococcus agalactiae and other streptococcal species, penicillin-resistant and sensitive staphylococci and Actinomyces pyogenes.
In staphylococcal and certain forms of streptococcal mastitis, an adequate duration of treatment is important in achieving both clinical and bacteriological cures. Orbenin L.A. with its slow release characteristics is designed to meet these requirements.
4.3 Contraindications
None.
4.4 Special warnings for each target species
None.
4.5 Special precautions for use
i) Special precautions for use in animals
Individual syringes must only be used once.
ii) Special precautions to be taken by the person administering the veterinary medicinal product to animals
Penicillins and cephalosporins may cause hypersensitivity (allergy) following injection, inhalation, ingestion or skin contact. Hypersensitivity to penicillins may lead to crossreactions to cephalosporins and vice versa. Allergic reaction 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.
4.6 Adverse reactions (frequency and seriousness)
None.
4.7 Use during pregnancy, lactation or lay
Orbenin L.A. is indicated for use in the lactating cow and for use in ewes at weaning.
4.8 Interaction with other medicinal products and other forms of interaction
None known.
4.9 Amounts to be administered and administration route
Cows
Dosage
The recommended dose is three infusions per infected quarter - one syringe administered every 48 hours.
Dosing guide
Clean and disinfect the teat with surgical spirit after milking; insert nozzle into the teat and apply gentle and continuous pressure until the suspension is expressed. The treated quarter(s) may be milked out at the next normal milking time.
Ewes
Dosage
A single infusion should be made into each udder half at weaning.
Administration
It is important that a simple hygienic procedure is followed. One operator should turn up and hold each ewe whilst a second person carries out the infusion technique. Clean and disinfect each teat end thoroughly with surgical spirit. Appose the syringe nozzle to the teat orifice and apply gentle, continuous pressure to express the suspension in the udder. Actual cannulation of the teat orifice is neither necessary nor desirable. Use a fresh syringe for each udder half to avoid the possibility of cross contamination during infusion.
4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
Orbenin L.A. is non-irritant to the udder tissues and well tolerated in the target species. No adverse effects are to be expected from an accidental overdose.
4.11 Withdrawal periods
Cattle (milk): 96 hours.
Sheep (milk): Not for use in ewes producing milk for human consumption.
Cattle and sheep (meat and offal): 7 days
5. PHARMACOLOGICAL PROPERTIES
Cloxacillin, a semi-synthetic β-lactam antibiotic, is active against Grampositive organisms, but is not destroyed by staphylococcal penicillinase. It is therefore active against penicillin resistant staphylococci which are an important cause of mastitis.
The antibiotic is bactericidal at the concentrations produced in the udder and is non-irritant to the udder tissues.
ATCVet Code: QJ51CF02
6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Hydrogenated Castor Oil
Silica Hydrophobic Colloidal
Butylated Hydroxyanisole
Arachis Oil
6.2 Incompatibilities
None.
6.3 Shelf-life
Shelf-life of the veterinary medicinal product as packaged for sale: 3 years.
6.4 Special precautions for storage
Store in a dry place.
Do not store above 25°C.
6.5 Nature and composition of immediate packaging
Polythene syringes in packs of 12 syringes per carton.
6.6 Special precautions for the disposal of unused veterinary medicinal product 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
Zoetis UK Limited
1st Floor, Birchwood Building
Springfield Drive
Leatherhead
Surrey
KT22 7LP
8. MARKETING AUTHORISATION NUMBER
Vm 42058/4090
9. DATE OF THE FIRST AUTHORISATION
14 January 1995
10. DATE OF REVISION OF THE TEXT
September 2020
Approved 04 September 2020