Orojet Lamb Oral Solution
Revised: May 2014
AN: 00135/2014
SUMMARY OF PRODUCT CHARACTERISTICS
NAME OF THE VETERINARY MEDICINAL PRODUCT
Orojet Lamb Oral Solution
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active substances: per ml
Neomycin Sulfate 70 mg
Streptomycin Sulfate 70 mg
Excipient(s):
Sodium methyl parahydroxybenzoate 0.112 % w/v
Sodium ethyl parahydroxybenzoate 0.023 % w/v
Sodium propyl parahydroxybenzoate 0.016 % w/v
For a full list of excipients, see section 6.1.
PHARMACEUTICAL FORM
Oral solution.
A clear brown solution.
CLINICAL PARTICULARS
Target species
Lambs.
Indications for use, specifying the target species
For prophylatic treatment in neonatal lambs, as an aid to prevention of enteric infection including watery mouth.
For the treatment of neomycin and streptomycin sensitive enteric infections in neonatal lambs.
Contraindications
Do not use in known cases of hypersensitivity to neomycin and / or streptomycin.
Special warnings
None.
Special precautions for use
Special precautions for use in animals
Avoid the introduction of contamination during use.
For oral use only.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
Streptomycin may occasionally cause skin sensitisation in humans. Contact with skin should therefore be kept to a minimum. Wash hands after use.
In case of accidental eye contact, wash eyes with copious amounts of water.
Adverse reactions (frequency and seriousness)
None known.
Use during pregnancy, lactation or lay
Not applicable.
Interaction with other medicinal products and other forms of interaction
None known.
Amounts to be administered and administration route
For oral administration only.
Lambs: prophylaxis in neonates – 1 ml per 5kg bodyweight (1 metered dose from pump) as soon as possible after birth, i.e. within one hour.
Treatment: 1 ml per 5 kg bodyweight twice daily for three to four days.
Overdose (symptoms, emergency procedures, antidotes), if necessary
The active ingredients are not significantly absorbed following oral administration.
Withdrawal period
Lambs must not be slaughtered for human consumption during treatment. Lambs may only be slaughtered for human consumption after 28 days following last treatment.
PHARMACOLOGICAL PROPERTIES
Broad-spectrum bactericidal antibiotics. Antibacterial activity is mainly against aerobic, gram-negative bacteria. Both neomycin and streptomycin are poorly absorbed from the gastro-intestinal tract due to their low degree of liquid solubility.
PHARMACEUTICAL PARTICULARS
List of excipients
Sodium methyl parahydroxybenzoate
Sodium ethyl parahydroxybenzoate
Sodium propyl parahydroxybenzoate
Citric acid monohydrate
Sodium Citrate Dihydrate
Caramel Cerestar
Water purified
Incompatibilities
None known.
Shelf life
Shelf-life of the veterinary medicinal product as packaged for sale: 18 months.
Shelf-life after first opening the immediate packaging: 14 days.
Special precautions for storage
Do not store above 25°C.
Protect from light.
Nature and composition of immediate packaging
Translucent high-density polyethylene bottles of nominal capacity 112 ml and 250 ml, heat-sealed with black screw on plastic caps and a dispensing pump. The dispenser is pre-set to deliver approximately 1 ml per shot. Each bottle contains 100 ml, 210 ml or 240 ml of liquid. Each bottle is packed in an individual carton.
Not all pack sizes may be marketed.
Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products
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: 42058/4093
DATE OF FIRST AUTHORISATION
Date: 26 July 1996
DATE OF REVISION OF THE TEXT
Date: May 2014
14 May 2014