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Pharmaceutical particulars
List of excipients
all-rac-α-Tocopherol (E-307)
Ethanol, anhydrous (E-1510)
Propylene glycol (E-1520)
Corn oil-mono-di-triglycerides
Macrogolglycerol hydroxystearate
Incompatibilities
In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products.
Shelf life
Shelf-life of the veterinary medicinal product as packaged for sale: 3 years.
Shelf-life after first opening the immediate packaging containing 5 ml or 17 ml oral solution): 70 days.
Shelf-life after first opening the immediate packaging containing 50 ml oral solution): 84 days.
Special precautions for storage
Store between 15°C and 30°C but preferably not below 20°C for more than one month. Storage in the refrigerator should be avoided.
Keep the bottle in the outer carton.
The product contains oily components from natural origin which can become solid at lower temperatures. A jelly-like formation may occur below 20°C which is however reversible at temperatures up to 30°C. Minor flakes or a slight sediment may still be observed. However, this does neither affect the dosing nor the efficacy and safety of the product.
Nature and composition of immediate packaging
Multi-dose type III amber glass bottle containing 5 ml or 17 ml oral solution closed with a rubber stopper and sealed with a polypropylene child-resistant screw cap. One bottle and a dispenser set (consisting of a PE dip tube and a 1 ml polypropylene syringe) packed in a cardboard box.
Multi-dose type III amber glass bottle containing 50 ml oral solution closed with a chlorobutyl rubber stopper and sealed with an aluminium tear-off cap. Each bottle is provided with two dispenser sets (consisting of a PE dip tube and a 1 ml or 4 ml polypropylene syringe) packed in a cardboard box. A polypropylene child-resistant screw cap is provided for closure of the bottle during the in-use period.
Pack sizes
1 x 5 ml bottle and one dispenser set
1 x 17 ml bottle and one dispenser set
1 x 50 ml bottle and two dispenser sets
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 product should be disposed of in accordance with local requirements.