Orbenin Dry Cow 500 Mg Intramammary Suspension
Revised: June 2014
AN: 00245/2014
SUMMARY OF PRODUCT CHARACTERISTICS
NAME OF THE VETERINARY MEDICINAL PRODUCT
ORBENIN Dry Cow 500 mg Intramammary Suspension
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active ingredient g/dose
Cloxacillin benzathine (equivalent to Cloxacillin 0.5)
Other ingredients
Mineral oil base to 3.0
For the full list of all other excipients see section 6.1
PHARMACEUTICAL FORM
Intramammary suspension.
White to off-white viscous suspension.
CLINICAL PARTICULARS
Target species
Cattle.
Indications for use, specifying the target species
For the infusion of cows at drying off, to treat mastitis infections and to provide protection against further infections during the dry period.
Contraindications
Do not use in the lactating cow.
Special warnings for each target species
None.
Special precautions for use
Special precautions for use in
animals
For single use
only.
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 cross reactions 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 may required urgent medical attention.
Wash hands after use.
Adverse reactions (frequency and seriousness)
None.
Use during pregnancy, lactation or lay
Not for use in lactating cows.
Interaction with other medicinal products and other forms of interaction
None known.
Amounts to be administered and administration route
One syringe per quarter, immediately after the final milking of
lactation. At drying off, clean and disinfect the teat following
the last milking, insert nozzle into the teat and apply
gentleand continuous pressure until the
suspension is expressed.
Each syringe must only be
used once. Part used syringes must be disposed of, see section 6.6
for disposal advice.
Overdose (symptoms, emergency procedures, antidotes), if necessary
Not applicable.
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 last treatment.
Animals must not be slaughtered for human consumption during treatment.
Cattle may be slaughtered only after 28 days from the last treatment.
PHARMACOLOGICAL PROPERTIES
The product is active against Gram-positive organisms associated with mastitis.
It is effectiveagainst Streptococcus agalactiaeand other Streptococcal species, straphylococci (penicillin resistant and sensitive strains) and Corynebacterium pyogenes. Cloxacillin is bactericidal in activity and is resistant to β-lactamases. Formulated in the long-acting aluminium stearate base the Benzathine salt provides continued activity over 3 to 4 weeks.
PHARMACEUTICAL PARTICULARS
List of excipients
Aluminium Stearate
Liquid Paraffin
Stearic Acid
Incompatibilities
None known.
Shelf-life
Shelf-life of the veterinary medicinal product as packaged for sale: 4 years.
Special precautions for storage
Do not store above 25°C.
Nature and composition of immediate packaging
Suspension for intramammary infusion in white low density polyethylene intramammary syringe barrel containing 3 g of product and plunger. The closure is a white low density polyethylene push-fit combined dual nozzle and cap.
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.
MARKETING AUTHORISATION HOLDER
Zoetis UK Limited
5th Floor, 6 St. Andrew Street
London
EC4A 3AE
MARKETING AUTHORISATION NUMBER
Vm:42058/4088
DATE OF THE FIRST AUTHORISATION
Date:29 March 1985
DATE OF REVISION OF THE TEXT
Date:June 2014
26 June 2014