Patient leaflet - Kexxtone
B. PACKAGE LEAFLET
PACKAGE LEAFLET:
Kexxtone 32.4g continuous-release intraruminal device for cattle
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1. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT
Marketing authorisation holder :
Elanco GmbH
Heinz-Lohmann-Str. 4
27472 Cuxhaven
Germany
Manufacturer responsible for batch release :
Elanco France S.A.S
26 Rue de la Chapelle
68330 Huningue
France
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2. NAME OF THE VETERINARY MEDICINAL PRODUCT
Kexxtone 32.4g continuous-release intraruminal device for cattle monensin
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3. STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
Monensin 32.4 g (equivalent to 35.2 g monensin sodium)
A cylindrical orange polypropylene intraruminal device uniquely identified with a number, fitted with wings, consisting of a core which presents as a stack of 12 subunits.
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4. INDICATION(S)
For the reduction in the incidence of ketosis in the peri-parturient dairy cow/heifer which is expected to develop ketosis.
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5. CONTRAINDICATIONS
Do not use in animals weighing less than 300 kg bodyweight.
Do not use in cases of hypersensitivity to the active substance or to any of the excipients.
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6. ADVERSE REACTIONS
In rare cases, digestive signs (e.g. diarrhoea, ruminant stomach disorder) have been observed.
In very rare cases, oesophagus obstruction has been observed.
The frequency of adverse reactions is defined using the following convention:
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– very common (more than 1 in 10 animals treated displaying adverse reaction(s))
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– common (more than 1 but less than 10 animals in 100 animals treated)
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– uncommon (more than 1 but less than 10 animals in 1,000 animals treated)
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– rare (more than 1 but less than 10 animals in 10,000 animals treated)
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– very rare (less than 1 animal in 10,000 animals treated, including isolated reports).
If you notice any side effects, even those not already listed in this package leaflet or you think that the medicine has not worked, please inform your veterinary surgeon.
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7. TARGET SPECIES
Cattle (dairy cows and heifers)
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8. DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION
Intraruminal use.
A single intraruminal device is to be administered to a dairy cow/heifer 3–4 weeks prior to expected calving, using an appropriate administration tool.
Kexxtone delivers an approximate average dose of 335 mg of monensin per day for approximately 95 days.
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9. ADVICE ON CORRECT ADMINISTRATION
Follow directions carefully.
Adequate animal restraint is required to properly administer this intraruminal device. Such restraint must limit forward/backward motion and allow the animal’s head to be held in the forward extended position and without pressure on the neck to prevent choking.
Each intraruminal device has an individual number along the intraruminal device body. This should be recorded with the corresponding animal identification number so that, should an intraruminal device be regurgitated, the animal can be identified.
Fold wings down along the intraruminal device body and insert the intraruminal device into an appropriate administration tool, orifice end first.
Standing to one side of the animal, restrain it with its head and neck stretched forward and held firmly against your side. Grasp the animal with one hand in the corner of the animal’s mouth. Introduce the administration tool into the mouth avoiding the front teeth. In order to avoid trauma and damage to the pharynx and oesophagus, do not use excessive force.
Insert the administration tool past the base of the tongue making sure to avoid the molar teeth. As the animal swallows the administration tool will move easily over the base of the tongue. DO NOT USE EXCESSIVE FORCE. If resistance is encountered, withdraw the tool slightly and repeat the procedure.
Be sure the head of the administration tool is past the base of the tongue. When the animal swallows, eject the intraruminal device from the administration tool.
Hold treated cattle in a confined area for 1 hour after administration to observe for failure to swallow or regurgitation. If this occurs re-administer the intraruminal device if undamaged. If damaged, administer a new intraruminal device. Recheck cattle for up to 4 days after dosing to observe for signs of an intraruminal device lodging in the oesophagus. In the event of early regurgitation, identify the animal by matching the animal ID number with the number on the intraruminal device.
Signs of lodging may include bloat which may be followed by coughing, drooling, inappetence and unthriftiness.
10.
WITHDRAWAL PERIOD(S)
Meat and offal: zero days
Milk: zero days
11. SPECIAL STORAGE PRECAUTIONS
Keep out of the sight and reach of children
Keep the foil tightly closed.
Shelf life after first opening the immediate packaging. 6 months
Do not use this veterinary medicinal product after the expiry date which is stated on the package after “EXP”. The expiry date refers to the last day of that month.
12.
SPECIAL WARNING(S)
Special precautions for use in animals:
Identification of animals for treatment should be at veterinary discretion. Risk factors may include a history of energy-deficiency-related diseases, high body condition score and parity.
Special precautions to be taken by the person administering the veterinary medicinal product to animals:
Exposure to the active substance may elicit an allergic response in susceptible individuals. People with known hypersensitivity to monensin or any of the excipients should avoid contact with the veterinary medicinal product.
Do not eat, drink or smoke when handling the veterinary medicinal product.
Use gloves when handling an intraruminal device, including during retrieval of a regurgitated intraruminal device.
Remove gloves and wash hands and exposed skin after handling intraruminal devices.
Other precautions
Ingestion or oral exposure to monensin can be fatal in dogs, horses, other equines or guinea fowl. Do not allow canine, horses, other equines or guinea fowl access to veterinary medicinal products containing monensin.
Due to the risk of bolus regurgitation, do not allow these species access to areas where treated cattle have been kept.
Keep dogs away from treated animals. Accidental ingestion of active ingredient by dogs has resulted in fatal consequences. In case of suspected ingestion by dogs, seek veterinary advice immediately.
Pregnancy and lactation:
Can be used during pregnancy and lactation.
Overdose (symptoms, emergency procedures, antidotes):
Accidental administration of more than one intraruminal device could result in some adverse reactions which are typical of monensin overdose, including decreased appetite, scouring and lethargy. These are generally transient. The highest tolerated dose is typically between 1 mg and 2 mg monensin/kg bodyweight/day.
Incompatibilities:
Not applicable
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13. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIALS, IF ANY
Any unused veterinary medicinal product, waste materials derived from such veterinary medicinal products or regurgitated intraruminal devices should be disposed of in accordance with local requirements.
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14. DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED <DD/MM/YY>
Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency.
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15. OTHER INFORMATION