Medine.co.uk

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