Econor (valnemulin) – Labelling - QJ01XQ02

PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE

ALUMINIUM-LINED PLASTIC BAGS

1.NAME OF THE VETERINARY MEDICINAL PRODUCT

Econor 10% premix for medicated feed for pigs and rabbits

Valnemulin

2.STATEMENT OF ACTIVE SUBSTANCES

Valnemulin

100 mg/g (equivalent to 106.5 mg/g valnemulin hydrochloride)

3.PHARMACEUTICAL FORM

Premix for medicated feeding stuff

4.PACKAGE SIZE

1 kg

25 kg

5.TARGET SPECIES

Pigs and rabbits

6.INDICATION(S)

7.METHOD AND ROUTE(S) OF ADMINISTRATION

In-feed use.

Mixing instructions:

Read the package leaflet before use.

8.WITHDRAWAL PERIOD(S)

Withdrawal period(s):

Pigs:

Meat and offal: 1 day.

Rabbits:

Meat and offal: Zero days.

9.SPECIAL WARNING(S), IF NECESSARY

Do not administer the product to pigs and rabbits receiving ionophores.

As an adjunct to treatment, good management and hygiene practices should be introduced in order to reduce the risk of infection and to control the potential build-up of resistance.

Especially in the case of swine dysentery, a targeted early eradication programme of the disease should be considered.

Special precautions for use in pigs

Adverse reactions have occurred in pigs following the use of Econor. Extreme care should therefore be taken in the use of Econor in pigs of the Danish and Swedish Landrace breeds, and their crossbreeds thereof, especially in younger pigs. When treating infections caused by Brachyspira spp., therapy should be based on local (regional, farm level) epidemiological information about susceptibility of the target bacteria.

Special warnings for use in rabbits

Clinical diagnosis should be confirmed by necropsy. The product should be used as part of a programme including measures aimed at controlling the disease on farm such as biosecurity and husbandry controls.

Only use in the case of confirmed epizootic rabbit enteropathy (ERE) outbreaks when diagnosis has been made clinically and confirmed by necropsy. Do not use prophylactically.

Official, national and regional antimicrobial policies should be taken into account when the product is used.

Use of the product deviating from the instructions given in the leaflet may increase the prevalence of bacteria resistant to valnemulin and may decrease the effectiveness of pleuromutilins.

Special precautions to be taken by the person administering the veterinary medicinal product to animals

When mixing the veterinary medicinal product, and handling the final feed containing the product, direct contact with the skin and mucous membranes should be avoided. Gloves should be worn when handling the veterinary medicinal product.

In case of accidental ingestion, seek medical advice immediately and show the package leaflet or the label to the physician.

People with known hypersensitivity to valnemulin should administer the veterinary medicinal product with caution.

See package leaflet for further information.

10.EXPIRY DATE

EXP {month/year}

11.SPECIAL STORAGE CONDITIONS

Do not store above 25 °C.

Store in the original container.

Part-used containers should be tightly closed following dispensing.

Shelf life when incorporated into meal pig feed and protected from light and moisture: 3 months. Shelf life when incorporated into pelleted pig feed and protected from light and moisture: 3 weeks. Shelf life when incorporated into common rabbit feed and protected from light and moisture: 4 weeks.

12.SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS OR WASTE MATERIALS, IF ANY

Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.

13.THE WORDS “FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE, IF APPLICABLE

For animal treatment only. To be supplied only on veterinary prescription.

14.THE WORDS “KEEP OUT OF THE SIGHT AND REACH OF CHILDREN”

Keep out of the sight and reach of children.

15.NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Elanco Europe Ltd.

Lilly House, Priestley Road

Basingstoke

RG24 9NL

UNITED KINGDOM

16.MARKETING AUTHORISATION NUMBER(S)

EU/2/98/010/017 (1 kg)

EU/2/98/010/018 (25 kg)

17.MANUFACTURER’S BATCH NUMBER

Batch {number}

PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE

ALUMINIUM-LINED PLASTIC BAGS

1.NAME OF THE VETERINARY MEDICINAL PRODUCT

Econor 50% premix for medicated feed for pigs

Valnemulin

2.STATEMENT OF ACTIVE SUBSTANCES

Valnemulin

500 mg/g (equivalent to 532.5 mg/g valnemulin hydrochloride)

3.PHARMACEUTICAL FORM

Premix for medicated feeding stuff

4.PACKAGE SIZE

1 kg

25 kg

5.TARGET SPECIES

Pigs

6.INDICATION(S)

7.METHOD AND ROUTE(S) OF ADMINISTRATION

In-feed use.

Mixing instructions:

Read the package leaflet before use.

8.WITHDRAWAL PERIOD(S)

Withdrawal period:

Meat and offal: 1 day.

9.SPECIAL WARNING(S), IF NECESSARY

Do not administer the product to pigs receiving ionophores.

As an adjunct to treatment, good management and hygiene practices should be introduced in order to reduce the risk of infection and to control the potential build-up of resistance.

Especially in the case of swine dysentery, a targeted early eradication programme of the disease should be considered.

Special precautions for use in pigs

Adverse reactions have occurred in pigs following the use of Econor. Their occurrence appears to be mainly associated with breed mixes that include Danish and/or Swedish Landrace. Extreme care should therefore be taken in the use of Econor in pigs of the Danish and Swedish Landrace breeds, and their crossbreeds thereof, especially in younger pigs. When treating infections caused by Brachyspira spp., therapy should be based on local (regional, farm level) epidemiological information about susceptibility of the target bacteria.

Special precautions to be taken by the person administering the veterinary medicinal product to animals

When mixing the veterinary medicinal product, and handling the final feed containing the product, direct contact with the skin and mucous membranes should be avoided. Gloves should be worn when handling the veterinary medicinal product.

In case of accidental ingestion, seek medical advice immediately and show the package leaflet or the label to the physician.

People with known hypersensitivity to valnemulin should administer the veterinary medicinal product with caution.

See package leaflet for further information.

10.EXPIRY DATE

EXP {month/year}

11.SPECIAL STORAGE CONDITIONS

Do not store above 25 °C.

Store in the original container.

Part-used containers should be tightly closed following dispensing.

Shelf life when incorporated into meal pig feed and protected from light and moisture: 3 months. Shelf life when incorporated into pelleted pig feed and protected from light and moisture: 3 weeks.

12.SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS OR WASTE MATERIALS, IF ANY

Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.

13.THE WORDS “FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE, IF APPLICABLE

For animal treatment only. To be supplied only on veterinary prescription.

14.THE WORDS “KEEP OUT OF THE SIGHT AND REACH OF CHILDREN”

Keep out of the sight and reach of children.

15.NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Elanco Europe Ltd.

Lilly House, Priestley Road

Basingstoke

RG24 9NL

UNITED KINGDOM

16.MARKETING AUTHORISATION NUMBER(S)

EU/2/98/010/021 (1 kg)

EU/2/98/010/022 (25 kg)

17.MANUFACTURER’S BATCH NUMBER

Batch {number}

PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE

ALUMINIUM-LINED PLASTIC BAGS

1.NAME OF THE VETERINARY MEDICINAL PRODUCT

Econor 10% oral powder for pigs

Valnemulin

2.STATEMENT OF THE ACTIVE AND OTHER SUBSTANCES

Valnemulin

100 mg/g (equivalent to 106.5 mg/g valnemulin hydrochloride)

3.PHARMACEUTICAL FORM

Oral powder

4.PACKAGE SIZE

1 kg

5.TARGET SPECIES

Pigs

6.INDICATION(S)

7.METHOD AND ROUTE OF ADMINISTRATION

Oral use.

Read the package leaflet before use

8.WITHDRAWAL PERIOD(S)

Withdrawal period(s):

Meat and offal: 1 day.

9.SPECIAL WARNING(S), IF NECESSARY:

Special precautions for use in animals:

Do not administer the veterinary medicinal product to pigs receiving monensin, salinomycin or narasin.

As an adjunct to medication, good management and hygiene practices should be introduced in order to reduce the risk of infection and to control the potential build-up of resistance.

Extreme care should be taken in the use of Econor in pigs of the Danish and Swedish Landrace breeds, and their crossbreeds thereof, especially in younger pigs.

Special precautions to be taken by the person administering the veterinary medicinal product to animals:

When mixing the veterinary medicinal product, and handling the final feed containing the product, direct contact with the skin and mucous membranes should be avoided. Gloves should be worn when handling the veterinary medicinal product.

In case of accidental ingestion, seek medical advice immediately and show the package leaflet or the label to the physician.

People with known hypersensitivity to valnemulin should administer the veterinary medicinal product with caution.

See package leaflet for further information.

10.EXPIRY DATE

EXP {month/year}

Once opened use within 6 months.

Medicated feed should be replaced, if not consumed within 24 hours.

11.SPECIAL STORAGE CONDITIONS

Do not store above 25 °C. Store in the original container.

Part-used containers should be tightly closed following dispensing.

12.SPECIFIC PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS OR WASTE MATERIALS, IF ANY

Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.

13.THE WORDS “FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE, IF APPLICABLE

For animal treatment only. To be supplied only on veterinary prescription.

14.THE WORDS “KEEP OUT OF THE SIGHT AND REACH OF CHILDREN”

Keep out of the sight and reach of children.

15.NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Elanco Europe Ltd.

Lilly House, Priestley Road

Basingstoke

RG24 9NL

UNITED KINGDOM

16.MARKETING AUTHORISATION NUMBER(S)

EU/2/98/010/025

17.MANUFACTURER’S BATCH NUMBER

Batch {number}

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