Econor - patient leaflet, side effects, dosage

B. PACKAGE LEAFLET

PACKAGE LEAFLET:

Econor 50% premix for medicated feed for pigs

• 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 :

Sandoz GmbH

Biochemiestrasse 10

6250 Kundl

AUSTRIA

• 2. NAME OF THE VETERINARY MEDICINAL PRODUCT

Econor 50% premix for medicated feed for pigs

Valnemulin hydrochloride

• 3. STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)

Econor 50% premix contains valnemulin in the form of valnemulin hydrochloride.

Valnemulin hydrochloride 532.5 mg/g

equivalent to valnemulin 500 mg/g.

Other ingredients:

Hypromellose

Talc

White to slight yellowish powder.

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.

Do not administer the product to pigs receiving ionophores.

• 6. ADVERSE REACTIONS

Adverse reactions following the use of Econor are mainly associated with breeds and cross breeds of Danish and/or Swedish Landrace.

Most common adverse reactions observed in these pigs are pyrexia, anorexia and in severe cases ataxia and recumbency. On affected farms, one third of the pigs treated were affected, with a mortality of 1%. A percentage of such pigs may also suffer oedema or erythema (posterior in distribution), and palpebral oedema. In controlled trials in susceptible animals mortality was less than 1%.

In the case of an adverse reaction, immediate withdrawal of medication is recommended. Severely affected pigs should be removed to clean dry pens and given appropriate treatment, including treatment for concurrent disease.

Valnemulin is well-accepted in feed, but administered at concentrations above 200 mg valnemulin / kg feed may result in transient reduction in food consumption associated with unpalatability during the first few days of feeding in pigs.

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)

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

Pigs

• 8. DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION

In-feed use.

The uptake of medicated feed depends on the clinical condition of the animal. In order to obtain the correct dosage, the concentration of Econor has to be adjusted. Inclusion levels may also need to be increased in older pigs or pigs on restricted feed to achieve target dosage.

Indication	Dosage (active substance)	Application period of medicated feed as the sole daily ration	Application in feed (premix)
Treatment of swine dysentery	3–4 mg/kg bodyweight/day	Minimum of 7 days and up to 4 weeks or until signs of disease disappear	Incorporation of 75 mg active substance per kg feed with: Econor 50% 150 mg/kg feed

This dose level is effective in the treatment of clinical disease, but higher dosages or longer duration of treatment may be necessary for complete elimination of infection. It is important to institute medication as early as possible in an outbreak of swine dysentery. If there is no response to treatment within 5 days, the diagnosis should be re-established.

Indication	Dosage (active substance)	Application period of medicated feed as the sole daily ration	Application in feed (premix)
Treatment of clinical signs porcine proliferative enteropathy (ileitis)	3–4 mg/kg bodyweight/day	2 weeks or until signs of disease disappear	Incorporation of 75 mg active substance per kg feed with: Econor 50% 150 mg/ kg feed

This dose level is effective under normal situation in the treatment of clinical signs of disease, but higher dosages or longer duration of treatment may be necessary for complete elimination of infection. It is important to institute medication as early as possible in an outbreak of porcine proliferative enteropathy. If there is no response to treatment within 5 days, the diagnosis should be re-established. For severely affected animals which fail to respond to treatment within 3–5 days, parenteral treatment should be considered.

Indication	Dosage (active substance)	Application period of medicated feed as the sole daily ration	Application in feed (premix)
Prevention of swine dysentery clinical signs of porcine colonic spirochaetosis (colitis)	1.0–1.5 mg/kg bodyweight/day	minimum of 7 days and up to 4 weeks 4 weeks	Incorporation of 25 mg active substance per kg feed with: Econor 50% 50 mg/ kg feed

Repeated use of valnemulin should be avoided by improving management practice and thorough cleansing and disinfection. Consideration should be given to the eradication of infection from the farm.

Indication	Dosage (active substance)	Application period of medicated feed as the sole daily ration	Application in feed (premix)
Treatment and prevention of swine enzootic pneumonia	10–12 mg/kg bodyweight/day	Up to 3 weeks	Incorporation of 200 mg active substance per kg feed with: Econor 50% 400 mg/kg feed

Secondary infection by organisms such as Pasteurella multocida and Actinobacillus pleuropneumoniae may complicate enzootic pneumonia and require specific medication.

ADVICE ON CORRECT ADMINISTRATION

Mixing instructions:

mg Econor 50% premix/kg feed = Dosage required (mg/kg) x 2 x bodyweight (kg)/Daily feed intake (kg)

The product has been shown to be stable to the pelleting process at temperatures of 75 °C. Aggressive pelleting conditions such as temperatures in excess of 80 °C, and the use of abrasive substances for pre- mixture should be avoided.

To achieve good mixture and homogeneity of incorporation, the use of a pre-mixture is required. The required quantity of product is thoroughly mixed with a feed ingredient of similar physical nature (e.g. wheat middlings) in the proportion: 1 part Econor 50% premix to 20 parts feed ingredient.

Consideration should be given to official guidance on the incorporation of medicated premixes in final feeds.

Meat and offal: 1 day.

• 11. SPECIAL STORAGE PRECAUTIONS

Keep out of the sight and reach of children.

Do not store above 25 °C.

Store in the original container.

Part-used containers should be tightly closed following dispensing.

Do not use this veterinary medicinal product after the expiry date which is stated on the label after “EXP”.

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

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

• 12. SPECIAL WARNING(S)

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 animals:

Adverse reactions have occurred 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.

Pregnancy and lactation:

Whilst studies in rats and mice have not produced any evidence of teratogenic effect, the safety during pregnancy and lactation has not been established in 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.

Interaction with other medicinal products and other forms of interaction:

Valnemulin has been shown to interact with ionophores such as monensin, salinomycin and narasin and may result in signs indistinguishable from an ionophore toxicosis. Animals should not receive products containing monensin, salinomycin or narasin during or at least 5 days before or after treatment with valnemulin. Severe growth depression, ataxia, paralysis or death may result.

Overdose (symptoms, emergency procedures, antidotes):

Toxic signs have not been seen in pigs given 5 times the recommended dose.

• 13. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIALS, IF ANY

Medicines should not be disposed of via wastewater or household waste.

Ask your veterinary surgeon how to dispose of medicines no longer required. These measures should help to protect the environment.

• 14. DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED

Detailed information on this veterinary medicinal product is available on the website of the European

Medicines Agency.

• 15. OTHER INFORMATION

Valnemulin is an antibiotic belonging to the pleuromutilin group, which acts by the inhibition of the initiation of protein synthesis at the level of the bacterial ribosome.

Econor 50% premix for medicated feed for pigs is available in 1 kg and 25 kg bags.

Not all pack sizes may be marketed.

For any information about this veterinary medicinal product, please contact the marketing authorisation holder.

PACKAGE LEAFLET: Econor 10% oral powder for pigs

• 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% oral powder for pigs

Valnemulin hydrochloride

STATEMENT OF THE ACTIVE AND OTHER SUBSTANCES

Valnemulin hydrochloride 106.5 mg/g

equivalent to valnemulin 100 mg/g.

Other ingredients

Hypromellose

Talc

Silica Colloidal anhydrous

Isopropyl myristate

Lactose.

White to pale yellow powder.

• 4. INDICATION(S)

The treatment of swine dysentery.

The treatment of clinical signs of porcine proliferative enteropathy (ileitis).

Treatment of swine enzootic pneumonia.

• 5. CONTRAINDI­CATIONS

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

• 6. ADVERSE REACTIONS

Adverse reactions following the use of Econor are mainly associated with breeds and cross breeds of Danish and/or Swedish Landrace.

Most common adverse reactions observed in these pigs are pyrexia, anorexia and in severe cases ataxia and recumbency. On affected farms, one third of the pigs treated were affected, with a mortality of 1%. A percentage of such pigs may also suffer oedema or erythema (posterior in distribution), and palpebral oedema. In controlled trials in susceptible animals mortality was less than 1%.

In the case of an adverse reaction, immediate withdrawal of medication is recommended. Severely affected pigs should be removed to clean dry pens and given appropriate treatment, including treatment for concurrent disease.

Valnemulin is well-accepted in feed, but administered at concentrations above 200 mg valnemulin / kg feed may result in transient reduction in food consumption associated with unpalatability during the first few days of feeding.

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)

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

Pigs

• 8. DOSAGE FOR EACH SPECIES, ROUTE AND METHOD OF ADMINISTRATION

Oral use.

For use in individual pigs on farms where only a small number of pigs are to receive the veterinary medicinal product. Larger groups should be treated with medicated feeding stuff containing the premix.

For severely affected animals which fail to respond to treatment within 3–5 days, parenteral treatment should be considered.

Treatment of swine dysentery

The recommended dose of valnemulin is 3–4 mg/kg bodyweight/day for a minimum of 7 days and up to 4 weeks or until signs of disease disappear.

This dose level is effective in the treatment of clinical disease, but higher doses or longer duration of treatment may be necessary for complete elimination of infection. It is important to institute treatment as early as possible in an outbreak of swine dysentery. If there is no response to treatment within 5 days, the diagnosis should be re-established.

Treatment of clinical signs of porcine proliferative enteropathy (ileitis)

The recommended dose of valnemulin is 3–4 mg/kg bodyweight/day for 2 weeks or until signs of disease disappear.

This dose level is effective under normal situations in the treatment of clinical signs of disease, but higher doses or longer duration of treatment may be necessary for complete elimination of infection. It is important to institute treatment as early as possible in an outbreak of porcine proliferative enteropathy. If there is no response to treatment within 5 days, the diagnosis should be re-established.

Treatment of swine enzootic pneumonia

The recommended dose of valnemulin is 10–12 mg/kg bodyweight/day for up to 3 weeks.

At the recommended dose of 10–12 mg/kg bodyweight lung lesions and weight loss are reduced, but infection with Mycoplasma hyopneumoniae is not eliminated. Secondary infection by organisms such as Pasteurella multocida and Actinobacillus pleuropneumoniae may complicate enzootic pneumonia and require specific treatment.

• 9. ADVICE ON CORRECT ADMINISTRATION

The amount of feed mixed with Econor which is necessary for treatment should be prepared daily.

Daily dose calculation: Amount Econor (mg) required = Dose required (mg/kg) x pig bodyweight (kg) x 10 / daily feed intake (in kg).

This is achieved by thoroughly mixing the required amount of Econor oral powder into the daily ration for each individual pig. The veterinary medicinal product can be used in dry or liquid feeds, where water or milk co-products have been added. Scoops of 2 sizes are provided for measuring the correct amount of the veterinary medicinal product for mixing with the daily ration, according to the dosage guidance table below. The feed containing the oral powder should be provided as the sole ration for the treatment periods recommended above. The veterinary medicinal product may be mixed in liquid feeds containing water, or milk-based co-products only.

The pigs to be treated should be weighed to calculate the correct dose of Econor oral powder to be given and the amount of feed that the pig is likely to consume should be estimated, based on a daily feed intake equivalent to 5% of bodyweight for growing pigs.

Feed consumption may be reduced in clinically sick animals and also in older pigs therefore feed intake may need to be adjusted to achieve target dosage intake.

The correct quantity of Econor oral powder should be added to the estimated quantity of the daily ration for each pig, in a bucket or suitable receptacle and thoroughly mixed.

Dosage guidance table

Pig type	Bodyweight (kg)	Dose rate(mg/kg bodyweight)	Econor 10% oralpowder (g)
Weaner	25	4	1
		12	3
Grower	50	4	2
		12	6
Finisher	100	4	4
		12	12
Sow	200	4	8
		12	24

Scoops – two scoops measuring 1 g and 3 g of Econor 10% oral powder are supplied. NB: a level scoop of the veterinary medicinal product should be measured.

To achieve good mixture and homogeneity, the use of a pre-mixture can be used. The required quantity of Econor is thoroughly mixed with the feed in the proportion: 1 part Econor oral powder to 10 parts feed before the final addition of the remainder of the feed.

Meat and offal: 1 day.

• 11. SPECIAL STORAGE PRECAUTIONS

Keep out of the sight and reach of children.

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

Part-used containers should be tightly closed following dispensing.

Once opened use within 6 months.

Feed to which the Econor oral powder has been added should be replaced if not consumed within 24 hours.

Do not use after the expiry date which is stated on the label after “EXP”.

• 12. SPECIAL WARNING(S)

Special warnings for each target species:

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

Special precautions for use in animals:

Adverse reactions have occurred 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 label to the physician.

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

Pregnancy and lactation:

Whilst studies in rats and mice have not produced any evidence of teratogenic effect, the safety during pregnancy and lactation has not been established in pigs.

Interaction with other medicinal products and other forms of interaction:

Valnemulin has been shown to interact with ionophores such as monensin, salinomycin and narasin, and may result in signs indistinguishable from an ionophore toxicosis. Animals should not receive monensin, salinomycin or narasin during or at least 5 days before or after treatment with valnemulin.

Severe growth depression, ataxia, paralysis or death may result.

Overdose (symptoms, emergency procedures, antidotes):

Toxic signs have not been seen in pigs given 5 times the recommended dose.

• 13. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIALS, IF ANY

Medicines should not be disposed of via wastewater or household waste.

Ask your veterinary surgeon how to dispose of medicines no longer required. These measures should help to protect the environment.

• 14. DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED

Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency.

• 15. OTHER INFORMATION