Econor
Land: Europäische Union
Sprache: Englisch
Quelle: EMA (European Medicines Agency)
Gebrauchsinformation
(PIL)
03-09-2019
Fachinformation
(SPC)
03-09-2019
Öffentlichen Beurteilungsberichts
(PAR)
07-12-2018
Wirkstoff:
valnemulin
Verfügbar ab:
Elanco GmbH
ATC-Code:
QJ01XQ02
INN (Internationale Bezeichnung):
valnemulin
Therapiegruppe:
Pigs; Rabbits
Therapiebereich:
Antiinfectives for systemic use
Anwendungsgebiete:
PigsThe treatment and prevention of swine dysentery. The treatment of clinical signs of porcine proliferative enteropathy (ileitis). The prevention of clinical signs of porcine colonic spirochaetosis (colitis) when the disease has been diagnosed in the herd. Treatment and prevention of swine enzootic pneumonia. At the recommended dosage of 10–12 mg/kg bodyweight lung lesions and weight loss are reduced, but infection with Mycoplasma hyopneumoniae is not eliminated.RabbitsReduction of mortality during an outbreak of epizootic rabbit enteropathy (ERE). Treatment should be started early in the outbreak, when the first rabbit has been diagnosed with the disease clinically.
Produktbesonderheiten:
Revision: 21
Berechtigungsstatus:
Authorised
Berechtigungsdatum:
1999-03-12
Gebrauchsinformation
21
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE - COMBINED LABEL
AND PACKAGE LEAFLET
ALUMINIUM-LINED PLASTIC BAGS
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
_ _
Econor 10% premix for medicated feed for pigs and rabbits
Valnemulin hydrochloride
3.
STATEMENT OF THE ACTIVE SUBSTANCE (S) AND OTHER INGREDIENTS
Econor 10% premix contains valnemulin in the form of valnemulin
hydrochloride.
Valnemulin hydrochloride
106.5 mg/g
equivalent to valnemulin 100 mg/g.
OTHER INGREDIENTS:
Hypromellose
Talc
Colloidal anhydrous silica
Isopropyl myristate
Lactose.
White to slight yellowish powder.
4.
PHARMACEUTICAL FORM
_ _
Premix for medicated feeding stuff
_ _
_ _
5.
PACKAGE SIZE
_ _
1 kg
25 kg
22
6.
INDICATION(S)
Pigs:
The treatment and prevention of swine dysentery.
The treatment of clinical signs of porcine proliferative enteropathy
(ileitis).
The prevention of clinical signs of porcine colonic spirochaetosis
(colitis) when the disease has been
diagnosed in the herd.
Treatment and prevention of swine enzootic pneumonia. At the
recommended dosage of 10–12 mg/kg
bodyweight, lung lesions and weight loss are reduced, but infection
with
_Mycoplasma hyopneumoniae _
is not eliminated.
Rabbits:
Reduction of mortality during an outbreak of epizootic rabbit
enteropathy (ERE). Treatment should be
started early in the outbreak, when the first rabbit has been
diagnosed with the disease clinically.
7.
CONTRAINDICATIONS
Do not administer the product to pigs or rabbits receiving ionophores.
Do not overdose in rabbits – increased doses may disturb
gastrointestinal flora leading to the
development of enterotoxaemia.
8.
ADVERSE REACTIONS
_ _
Rabbits:
See section “Special warning(s)”
Pigs:
Adverse r
Lesen Sie das vollständige Dokument
Fachinformation
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Econor 50% premix for medicated feed for pigs
Econor 10% premix for medicated feed for pigs and rabbits
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Econor contains valnemulin in the form of valnemulin hydrochloride.
ECONOR 50%
ECONOR 10%
ACTIVE SUBSTANCE
Valnemulin hydrochloride
532.5 mg/g
106.5 mg/g
Equivalent to
valnemulin base
500 mg/g
100 mg/g
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Premix for medicated feeding stuff
White to slight yellowish powder
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Pigs and rabbits
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
ECONOR 50%
The treatment and prevention of swine dysentery.
The treatment of clinical signs of porcine proliferative enteropathy
(ileitis).
The prevention of clinical signs of porcine colonic spirochaetosis
(colitis) when the disease has been
diagnosed in the herd.
Treatment and prevention of swine enzootic pneumonia. At the
recommended dosage of 10–12 mg/kg
bodyweight lung lesions and weight loss are reduced, but infection
with
_Mycoplasma hyopneumoniae_
is not eliminated.
ECONOR 10%
Pigs:
The treatment and prevention of swine dysentery.
The treatment of clinical signs of porcine proliferative enteropathy
(ileitis).
The prevention of clinical signs of porcine colonic spirochaetosis
(colitis) when the disease has been
diagnosed in the herd.
Treatment and prevention of swine enzootic pneumonia. At the
recommended dosage of 10–12 mg/kg
bodyweight lung lesions and weight loss are reduced, but infection
with
_Mycoplasma hyopneumoniae_
is not eliminated.
Rabbits:
Reduction of mortality during an outbreak of epizootic rabbit
enteropathy (ERE).
Treatment should be started early in the outbreak, when the first
rabbit has been diagnosed with the
disease clinically.
3
4.3
CONTRAINDICATIONS
Do not administer the veterinary medicinal product to pigs or rabbits
receiving ionophores.
Do not overdose in rabbits – increased doses may distu
Lesen Sie das vollständige Dokument
