Kexxtone

Maa: Euroopan unioni

Kieli: englanti

Lähde: EMA (European Medicines Agency)

Aktiivinen ainesosa:

monensin (as monensin sodium)

Saatavilla:

Elanco GmbH

ATC-koodi:

QA16QA06

INN (Kansainvälinen yleisnimi):

monensin

Terapeuttinen ryhmä:

Cattle (cows and heifers)

Terapeuttinen alue:

Drugs for prevention and/or treatment of acetonemia

Käyttöaiheet:

For the reduction in the incidence of ketosis in the peri-parturient dairy cow/heifer which is expected to develop ketosis.

Tuoteyhteenveto:

Revision: 9

Valtuutuksen tilan:

Authorised

Valtuutus päivämäärä:

2013-01-28

Pakkausseloste

14
B. PACKAGE LEAFLET
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PACKAGE LEAFLET:
KEXXTONE 32.4G CONTINUOUS-RELEASE INTRARUMINAL DEVICE FOR CATTLE
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
2.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Kexxtone 32.4g continuous-release intraruminal device for cattle
monensin
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.
4.
INDICATION(S)
For the reduction in the incidence of ketosis in the peri-parturient
dairy cow/heifer which is expected
to develop ketosis.
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.
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:
- very common (more than 1 in 10 animals treated displaying adverse
reaction(s))
- common (more than 1 but less than 10 animals in 100 animals treated)
- uncommon (more than 1 but less than 10 animals in 1,000 animals
treated)
- rare (more than 1 but less than 10 animals in 10,000 animals
treated)
- very rare (less than 1 animal in 10,000 animals treated, including
isolated reports).
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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.
7.
TARGET SPECIES
Cattle (dairy cows and heifers)
8.
DO

Valmisteyhteenveto

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Kexxtone 32.4g continuous-release intraruminal device for cattle
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE SUBSTANCE:
Monensin
32.4 g (equivalent to 35.2 g monensin sodium)
Each intraruminal device contains 12 subunits each containing 2.7 g
monensin (equivalent to 2.9 g
monensin sodium).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Continuous-release intraruminal device.
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.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Cattle (dairy cows and heifers)
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the reduction in the incidence of ketosis in the peri-parturient
dairy cow/heifer which is expected
to develop ketosis.
4.3
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.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
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.
In the event of early regurgitation, identify the animal by matching
the animal ID number with the
number on the intraruminal device and re-administer an undamaged
intraruminal device (See section
4.5).
4.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
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,
3
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.
Signs of lodging may include bloat which may be followed by coughing,
droolin