Econor

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

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Patient Information leaflet Patient Information leaflet (PIL)
03-09-2019
Summary of Product characteristics Summary of Product characteristics (SPC)
03-09-2019
Public Assessment Report Public Assessment Report (PAR)
07-12-2018

Active ingredient:

valnemulin

Available from:

Elanco GmbH

ATC code:

QJ01XQ02

INN (International Name):

valnemulin

Therapeutic group:

Pigs; Rabbits

Therapeutic area:

Antiinfectives for systemic use

Therapeutic indications:

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.

Product summary:

Revision: 21

Authorization status:

Authorised

Authorization date:

1999-03-12

Patient Information leaflet

                                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
                                
                                Read the complete document

Summary of Product characteristics

                                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
                                
                                Read the complete document

Similar products

Active ingredient valnemulin

valnemulin

ATC code QJ01XQ02

QJ01XQ02

Marketed by Elanco GmbH

Elanco GmbH

INN (International Name) valnemulin

valnemulin

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Patient Information leaflet Patient Information leaflet Bulgarian 03-09-2019
Summary of Product characteristics Summary of Product characteristics Bulgarian 03-09-2019
Public Assessment Report Public Assessment Report Bulgarian 07-12-2018
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Summary of Product characteristics Summary of Product characteristics Spanish 03-09-2019
Public Assessment Report Public Assessment Report Spanish 07-12-2018
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Summary of Product characteristics Summary of Product characteristics Czech 03-09-2019
Public Assessment Report Public Assessment Report Czech 07-12-2018
Patient Information leaflet Patient Information leaflet Danish 03-09-2019
Summary of Product characteristics Summary of Product characteristics Danish 03-09-2019
Public Assessment Report Public Assessment Report Danish 07-12-2018
Patient Information leaflet Patient Information leaflet German 03-09-2019
Summary of Product characteristics Summary of Product characteristics German 03-09-2019
Public Assessment Report Public Assessment Report German 07-12-2018
Patient Information leaflet Patient Information leaflet Estonian 03-09-2019
Summary of Product characteristics Summary of Product characteristics Estonian 03-09-2019
Public Assessment Report Public Assessment Report Estonian 07-12-2018
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Summary of Product characteristics Summary of Product characteristics Greek 03-09-2019
Public Assessment Report Public Assessment Report Greek 07-12-2018
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Summary of Product characteristics Summary of Product characteristics French 03-09-2019
Public Assessment Report Public Assessment Report French 07-12-2018
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Summary of Product characteristics Summary of Product characteristics Italian 03-09-2019
Public Assessment Report Public Assessment Report Italian 07-12-2018
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Summary of Product characteristics Summary of Product characteristics Latvian 03-09-2019
Public Assessment Report Public Assessment Report Latvian 07-12-2018
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Summary of Product characteristics Summary of Product characteristics Lithuanian 03-09-2019
Public Assessment Report Public Assessment Report Lithuanian 07-12-2018
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Summary of Product characteristics Summary of Product characteristics Hungarian 03-09-2019
Public Assessment Report Public Assessment Report Hungarian 07-12-2018
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Summary of Product characteristics Summary of Product characteristics Maltese 03-09-2019
Public Assessment Report Public Assessment Report Maltese 07-12-2018
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Summary of Product characteristics Summary of Product characteristics Dutch 03-09-2019
Public Assessment Report Public Assessment Report Dutch 07-12-2018
Patient Information leaflet Patient Information leaflet Polish 03-09-2019
Summary of Product characteristics Summary of Product characteristics Polish 03-09-2019
Public Assessment Report Public Assessment Report Polish 07-12-2018
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Summary of Product characteristics Summary of Product characteristics Portuguese 03-09-2019
Public Assessment Report Public Assessment Report Portuguese 07-12-2018
Patient Information leaflet Patient Information leaflet Romanian 03-09-2019
Summary of Product characteristics Summary of Product characteristics Romanian 03-09-2019
Public Assessment Report Public Assessment Report Romanian 07-12-2018
Patient Information leaflet Patient Information leaflet Slovak 03-09-2019
Summary of Product characteristics Summary of Product characteristics Slovak 03-09-2019
Public Assessment Report Public Assessment Report Slovak 07-12-2018
Patient Information leaflet Patient Information leaflet Slovenian 03-09-2019
Summary of Product characteristics Summary of Product characteristics Slovenian 03-09-2019
Public Assessment Report Public Assessment Report Slovenian 07-12-2018
Patient Information leaflet Patient Information leaflet Finnish 03-09-2019
Summary of Product characteristics Summary of Product characteristics Finnish 03-09-2019
Public Assessment Report Public Assessment Report Finnish 07-12-2018
Patient Information leaflet Patient Information leaflet Swedish 03-09-2019
Summary of Product characteristics Summary of Product characteristics Swedish 03-09-2019
Public Assessment Report Public Assessment Report Swedish 07-12-2018
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Summary of Product characteristics Summary of Product characteristics Norwegian 03-09-2019
Patient Information leaflet Patient Information leaflet Icelandic 03-09-2019
Summary of Product characteristics Summary of Product characteristics Icelandic 03-09-2019
Patient Information leaflet Patient Information leaflet Croatian 03-09-2019
Summary of Product characteristics Summary of Product characteristics Croatian 03-09-2019
Public Assessment Report Public Assessment Report Croatian 07-12-2018

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