Emdocam - patient leaflet, side effects, dosage

B. PACKAGE LEAFLET

PACKAGE LEAFLET:

Emdocam 20 mg/ml solution for injection for cattle, pigs and horses

• 1. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT

Marketing authorisation holder

Emdoka bvba

• J. Lijsenstraat 16

B-2321 Hoogstraten

Belgium

Manufacturer responsible for batch release:

Produlab Pharma bv

NL-4941 SJ Raamsdonksveer

The Netherlands

• 2. NAME OF THE VETERINARY MEDICINAL PRODUCT

Emdocam 20 mg/ml solution for injection for cattle, pigs and horses meloxicam

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

One ml contains:

Active substance:

Meloxicam 20 mg

Excipient:

Ethanol (96%) 150 mg

Clear yellow solution for injection.

• 4. INDICATION(S)

Cattle

For use in acute respiratory infection with appropriate antibiotic therapy to reduce clinical signs in cattle.

For use in diarrhoea in combination with oral re-hydration therapy to reduce clinical signs in calves of over one week of age and young, non-lactating cattle.

For adjunctive therapy in the treatment of acute mastitis, in combination with antibiotic therapy.

For the relief of post-operative pain following dehorning in calves.

Pigs

For use in non-infectious locomotor disorders to reduce the symptoms of lameness and inflammation.

For adjunctive therapy in the treatment of puerperal septicaemia and toxaemia (mastitis-metritis-agalactia syndrome) with appropriate antibiotic therapy.

Horses

For use in the alleviation of inflammation and relief of pain in both acute and chronic musculo-skeletal disorders.

For the relief of pain associated with equine colic.

• 5. CONTRAINDI­CATIONS

Do not use in horses less than 6 weeks of age.

Do not use in pregnant or lactating mares.

Do not use in animals suffering from impaired hepatic, cardiac or renal function and haemorrhagic disorders, or where there is evidence of ulcerogenic gastrointestinal lesions.

Do not use in case of hypersensitivity to the active substance or to any of the excipients.

For the treatment of diarrhoea in cattle, do not use in animals of less than one week of age.

• 6. ADVERSE REACTIONS

A slight transient swelling at the injection site following subcutaneous administration was observed in less than 10 % of the cattle treated in clinical studies.

In horses, a transient swelling at the injection site can occur but resolves without intervention.

In very rare cases anaphylactoid reactions, which may be serious (including fatal), may occur and should be treated symptomatically.

• – The frequency of adverse reactions is defined using the following convention:

• – very common (more than 1 in 10 animals treated displaying adverse reactions)

• – 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

Cattle, pigs and horses

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

Cattle

Single subcutaneous or intravenous injection at a dose of 0.5 mg meloxicam/kg body weight (i.e.

• 2.5 ml/100 kg body weight) in combination with antibiotic therapy or with oral re-hydration therapy, as appropriate.

Pigs

Single intramuscular injection at a dose of 0.4 mg meloxicam/kg body weight (i.e. 2 ml/100 kg body weight) in combination with antibiotic therapy, as appropriate. If required, a second administration of meloxicam can be given after 24 hours.

Horses

Single intravenous injection at a dose of 0.6 mg meloxicam/kg body weight (i.e. 3 ml/100 kg body weight).

For use in the alleviation of inflammation and the relief of pain in both acute and chronic musculo-skeletal disorders, a suitable oral therapy containing meloxicam, administered in accordance with label recommendations, may be used for continuation of treatment.

• 9. ADVICE ON CORRECT ADMINISTRATION

Avoid introduction of contamination during use.

Do not broach the vial more than 50 times.

• 10. WITHDRAWAL PERIODS

Cattle: meat and offal: 15 days; milk: 5 days

Pigs: meat and offal: 5 days

Horses: meat and offal: 5 days

Not authorised to use in horses producing milk for human consumption.

• 11. SPECIAL STORAGE PRECAUTIONS

Keep out of the sight and reach of children.

This veterinary medicinal product does not require any special storage conditions.

Do not use this veterinary medicinal product after the expiry date which is stated on the carton and vial after EXP. The expiry date refers to the last day of that month.

Shelf-life after first opening the container: 28 days.

• 12. SPECIAL WARNING(S)

Treatment of calves with Emdocam 20 minutes before dehorning reduces post-operative pain. Emdocam alone will not provide adequate pain relief during the dehorning procedure. To obtain adequate pain relief during surgery co-medication with an appropriate analgesic is needed.

Special precautions for use in animals:

If adverse reactions occur, treatment should be discontinued and the advice of a veterinarian should be sought.

Avoid use in very severely dehydrated, hypovolaemic or hypotensive animals which require parenteral rehydration, as there may be a potential risk of renal toxicity.

In case of inadequate relief of pain when used in the treatment of equine colic, careful re-evaluation of the diagnosis should be made as this could indicate the need for surgical intervention.

Special precautions to be taken by the person administering the veterinary medicinal product to animals : Accidental self-injection may give rise to pain. People with known hypersensitivity to Non-Steroidal AntiInflammatory Drugs (NSAIDs) should avoid contact with the veterinary medicinal product.

In case of accidental self-injection, seek medical advice immediately and show this package leaflet or the label to the physician.

Pregnancy and lactation

Cattle and pigs: Can be used during pregnancy and lactation.

Horses: Do not use in pregnant and lactating mares.

Interactions with other medicinal products and other forms of interaction :

Do not administer concurrently with glucocorticos­teroids, other non-steroidal anti-inflammatory drugs or with anticoagulant agents.

Overdose (symptoms, emergency procedures, antidotes) :

In case of overdose, symptomatic treatment should be initiated.

Incompatibili­ties:

In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products.

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

Any unused 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

Pack size of 1 colourless Type I glass vial containing 50 ml, 100 ml or 250 ml. Each vial is closed with a bromobutyl rubber stopper and sealed with an aluminium cap.

Not all pack sizes may be marketed.

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

Belgie/Belgiqu­e/Belgien Emdoka bvba John Lijsenstraat 16 BE-2321 Hoogstraten Tel : +32 3 315 04 26	Lietuva OU Zoovetvaru Uusaru 5 EE-Saue 76505 Tel: +372 6 709 006
PenySnuKa Efcnrapua EHOCOEPA OAPM EOOfl yn.TOpuň rarapuH N° 50 BG rp. KocTUH6pog 2230 Ten: + 359 885917017	Luxembourg/Lu­xemburg Emdoka bvba John Lijsenstraat 16 BE-2321 Hoogstraten Tel : +32 3 315 04 26
Česká republika BIOPHARM, Výzkumný ústav biofarmacie a veterinárních léčiv, a.s Pohoří – Chotouň 90 CZ-254 49 Jílové u Prahy	Magyarorszag Meditrix Kft. Ady E. u. 5 H-7020 Dunafoldvar Tel.: +36 75 542 940

Tel: +420 241 950 383

Danmark ChemVet dk A/S A.C. Illums Vej 6 DK-8600 Silkeborg Tlf: +45 8681 7522	Malta Emdoka bvba John Lijsenstraat 16 BE-2321 Hoogstraten Tel : +32 3 315 04 26
Deutschland WDT eG Siemensstr. 14 D-30827 Garbsen Tel: +49 5131 705 0	Nederland Emdoka bvba John Lijsenstraat 16 BE-2321 Hoogstraten Tel : +32 3 315 04 26
Eesti OÜ Zoovetvaru Uusaru 5 EE-Saue 76505 Tel: +372 6 709 006	Norge Emdoka bvba John Lijsenstraat 16 BE-2321 Hoogstraten Tel : +32 3 315 04 26
EXXáSa FATRO-HELLAS SPLTD 2o %jl. 1 lAIANIA^AI IATQN GR-190 02 nAIANIA Tql: + 30 210 6644331 España Divasa-Farmavic S.A. Ctra. Sant Hipolit, km 71 E-08503 Gurb-Vic Tel: +34 93 886 01 00	Österreich Richter Pharma AG Feldgasse 19, A A-4600 Wels Tel: +43 7242 490 0 Polska Fatro Polska Sp. z o.o. ul. Bolonska 1 PL-55 040 Kobierzyce Tel.: +48 71 311 11 11
France Axience SAS Tour Essor – 14, rue Scandicci F-93500 Pantin Tél. +33 1 41 83 23 17	Portugal Divasa Farmavic de Portugal, Produtos e Equipamentos Veterinarios, Lda. Praceta Jaime C’ortecao N° 1 – R/C Loja Esq. 2625–170 Povoa de Santa Iria Tel: +351 219 739 130
Hrvatska Vet Consulting d.o.o. Matije Gupca 42 43500 Daruvar Tel: +385 43 440 527	Romania SC Altius SRL Str Iancu Capitanu nr 38 Ap 1 Sector 2, Bucuresti – RO Tel: + 40 021 310 88 80
Ireland Duggan Veterinary Supplies Ltd., Holycross, Thurles, Co Tipperary Ireland	Slovenija TPR d.o.o. Litostrojska cesta 44e, 1000 Ljubljana Slovenia Tel: +386 (0)1 505 5882

Tel: +353 (0) 504 43169

Ísland Emdoka bvba

Slovenská republika Emdoka bvba

John Lijsenstraat 16

BE-2321 Hoogstraten

Tel : +32 3 315 04 26

Italia

Azienda Terapeutica Italiana A.T.I. s.r.l.

Via Emilia 285

I-40064 Ozzano dell’Emilia – Bologna

Tel: +39 051 6512711

Kúnpog

Enúpog Ziaupivíóng KépiKaXg At5

Asojcp. Ziaoívou 28, 1060 AsuKGJoía, Kúnpog Tql: +357 22 447464

Latvija

OÜ Zoovetvaru

Uusaru 5

EE-Saue 76505

Tel: +372 6 709 006

John Lijsenstraat 16

BE-2321 Hoogstraten

Tel : +32 3 315 04 26

Suomi/Finland

Emdoka bvba

John Lijsenstraat 16

BE-2321 Hoogstraten

Tel : +32 3 315 04 26

Sverige

ChemVet dk A/S

A.C. Illums Vej 6

DK-8600 Silkeborg

Tel: +45 8681 7522

United Kingdom (Northern Ireland)

Duggan Veterinary Supplies Ltd.,

Holycross,

Thurles,

Co Tipperary

Ireland

Tel: +353 (0) 504 43169

PACKAGE LEAFLET:

Emdocam 15 mg/ml oral suspension for horses

• 1. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE:

Marketing Authorisation Holder:

Emdoka bvba

John Lijsenstraat 16

B-2321 Hoogstraten

Belgium.

Manufacturer responsible for batch release:

Produlab Pharma bv

NL-4941 SJ Raamsdonksveer

The Netherlands.

• 2. NAME OF THE VETERINARY MEDICINAL PRODUCT:

Emdocam 15 mg/ml oral suspension for horses

Meloxicam

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

Each ml contains:

Active substance :

Meloxicam 15.0 mg

Excipients :

Sodium benzoate

Yellow suspension.

• 4. INDICATIONS:

Alleviation of inflammation and relief of pain in both acute and chronic musculo-skeletal disorders in horses.

• 5. CONTRA-INDICATIONS:

Do not use in pregnant or lactating mares.

Do not use in horses suffering from gastrointestinal disorders such as irritation and haemorrhage, impaired hepatic, cardiac or renal function and haemorrhagic disorders.

Do not use in case of hypersensitivity to the active substance or to any of the excipients. Do not use in horses less than 6 weeks of age.

• 6. ADVERSE REACTIONS:

Isolated cases of adverse reactions typically associated with NSAIDs were observed in clinical trials (slight urticaria, diarrhoea). Symptoms were reversible.

Loss of appetite, lethargy, abdominal pain and colitis have been reported in very rare cases. Anaphylactoid reactions, which may be serious (including fatal), may occur and should be treated symptomatically in very rare cases.

If adverse reactions occur, treatment should be discontinued and the advice of a veterinarian should be sought.

The frequency of adverse reactions is defined using the following convention:

Very common (more than 1 in 10 animals displaying adverse reaction(s) during the course of one treatment)

Common (more than 1 but less than 10 animals in 100 animals)

Uncommon (more than 1 but less than 10 naimals in 1,000 animals)

Rare (more than 1 but less than 10 animals in 10,000 animals)

Very rare (less than 1 animals in 10,000 animals, including isolated reports)

If you notice any side effects, even those not already listed in this package leaflet or you think that the medicines has not worked, please inform your veterinary surgeon.

• 7. TARGET SPECIES:

Horses.

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

Dosage

Oral suspension to be administered at a dosage of 0.6 mg/kg body weight, once daily, up to 14 days.

Method and route of administration

Shake well before use. To be administered either mixed with a small quantity of food, prior to feeding, or directly into the mouth.

The suspension should be given using the measuring syringe provided in the package. The syringe fits onto the bottle and has volume scale and a “kg-body weight” scale which corresponds to the maintenance dose (i.e. 0.6 mg meloxicam / kg body weight).

After administration of the veterinary medicinal product, close the bottle by replacing the cap, wash the measuring syringe with warm water and let it dry.

• 9. ADVICE ON CORRECT ADMINISTRATION:

Avoid introduction of contamination during use.

• 10. WITHDRAWAL PERIODS:

Meat and offal: 3 days

Not authorised for use in horses producing milk for human consumption.

• 11. SPECIAL STORAGE PRECAUTIONS:

Keep out of the sight and reach of children.

This veterinary medicinal product does not require any special storage conditions.

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

Shelf-life after first opening the container: 6 months.

• 12. SPECIAL WARNINGS:

Special precautions for use in animals

Avoid use in any dehydrated, hypovolaemic or hypotensive animals as there is a potential risk of renal toxicity.

Special precautions to be taken by the person administering the product

People with known hypersensitivity to Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) should avoid contact with the veterinary medicinal product.

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

This product can cause eye irritation. In case of contact with the eyes, immediately rinse thoroughly with water.

Pregnancy, lactation or lay

See section “Contraindica­tions”.

Interactions with other medicinal products and other forms of interaction

Do not administer concurrently with glucocorticoids, other non-steroidal anti-inflammatory drugs or with anticoagulant agents.

Overdose (symptoms, emergency procedures, antidotes)

In the case of overdosage, symptomatic treatment should be initiated.

Incompatibili­ties:

In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products.

• 13. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIAL, 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:

Pack sizes :

Cardboard box with 1 bottle of 125 ml and a measuring syringe

Cardboard box with 1 bottle of 336 ml and a measuring syringe

Not all pack sizes may be marketed.

Belgie/Belgiqu­e/Belgien Emdoka bvba John Lijsenstraat 16 BE-2321 Hoogstraten Tel : +32 3 315 04 26	Lietuva OÜ Zoovetvaru Uusaru 5 EE-Saue 76505 Tel: +372 6 709 006
PenyßnuKa Etnrapua EHOCOEPA OAPM EOOfl yn.TOpuň rarapuH N 50 BG rp. KocTUHÖpog 2230 Ten: + 359 885917017	Luxembourg/Lu­xemburg Emdoka bvba John Lijsenstraat 16 BE-2321 Hoogstraten Tel : +32 3 315 04 26
Česká republika BIOPHARM, Výzkumný ústav biofarmacie a veterinárních léčiv, a.s Pohoří – Chotouň 90 CZ-254 49 Jílové u Prahy Tel: +420 241 950 383	Magyarorszag Meditrix Kft. Ady E. u. 5 H-7020 Dunaföldvar Tel.: +36 75 542 940
Danmark ChemVet dk A/S A.C. Illums Vej 6 DK-8600 Silkeborg Tlf: +45 8681 7522	Malta Emdoka bvba John Lijsenstraat 16 BE-2321 Hoogstraten Tel : +32 3 315 04 26
Deutschland WDT eG Siemensstr. 14 D-30827 Garbsen Tel: +49 5131 705 0	Nederland Emdoka bvba John Lijsenstraat 16 BE-2321 Hoogstraten Tel : +32 3 315 04 26
Eesti OÜ Zoovetvaru Uusaru 5 EE-Saue 76505 Tel: +372 6 709 006	Norge Emdoka bvba John Lijsenstraat 16 BE-2321 Hoogstraten Tel : +32 3 315 04 26
EXXáSa FATRO-HELLAS SPLTD 2o %jl. nAIANIAZ-ZnATQN GR-190 02 nAIANIA Tql: + 30 210 6644331 España Divasa-Farmavic S.A.	Österreich Richter Pharma AG Feldgasse 19, A A-4600 Wels Tel: +43 7242 490 0 Polska Fatro Polska Sp. z o.o. 51

Ctra. Sant Hipdlit, km 71 E-08503 Gurb-Vic Tel: +34 93 886 01 00	ul. Bolonska 1 PL-55 040 Kobierzyce Tel.: +48 71 311 11 11
France Axience SAS Tour Essor – 14, rue Scandicci F-93500 Pantin Tel. +33 1 41 83 23 17	Portugal Divasa Farmavic de Portugal, Produtos e Equipamentos Veterinarios, Lda. Praceta Jaime C’ortecao N° 1 – R/C Loja Esq. 2625–170 Povoa de Santa Iria Tel: +351 219 739 130
Hrvatska Vet Consulting d.o.o. Matije Gupca 42 43500 Daruvar Tel: +385 43 440 527	Romania SC Altius SRL Str Iancu Capitanu nr 38 Ap 1 Sector 2, Bucuresti – RO Tel: + 40 021 310 88 80
Ireland Duggan Veterinary Supplies Ltd., Holycross, Thurles, Co Tipperary Ireland	Slovenija TPR d.o.o. Litostrojska cesta 44e, 1000 Ljubljana Slovenia Tel: +386 (0)1 505 5882

Tel: +353 (0) 504 43169

Ísland Emdoka bvba John Lijsenstraat 16 BE-2321 Hoogstraten Tel : +32 3 315 04 26	Slovenská republika Emdoka bvba John Lijsenstraat 16 BE-2321 Hoogstraten Tel : +32 3 315 04 26
Italia Azienda Terapeutica Italiana A.T.I. s.r.l. Via Emilia 285 I-40064 Ozzano dell’Emilia – Bologna Tel: +39 051 6512711	Suomi/Finland Emdoka bvba John Lijsenstraat 16 BE-2321 Hoogstraten Tel : +32 3 315 04 26
Kúnpog Enúpog Ziaupiviöng KspiKaZg At5 Asojcp. Ziaoivou 28, 1060 Asuróla, Kúnpog Tql: +357 22 447464	Sverige ChemVet dk A/S A.C. Illums Vej 6 DK-8600 Silkeborg Tel: +45 8681 7522
Latvija OÜ Zoovetvaru Uusaru 5 EE-Saue 76505 Tel: +372 6 709 006	United Kingdom (Northern Ireland) Duggan Veterinary Supplies Ltd., Holycross, Thurles, Co Tipperary Ireland Tel: +353 (0) 504 43169

PACKAGE LEAFLET:

Emdocam 5 mg/ml solution for injection for cattle and 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 :

Emdoka bvba

John Lijsenstraat 16

2321 Hoogstraten

Belgium

Manufacturer responsible for the batch release :

Produlab Pharma B.V.

Forellenweg 16

4941 SJ Raamsdonksveer

The Netherlands

• 2. NAME OF THE VETERINARY MEDICINAL PRODUCT

Emdocam 5 mg/ml solution for injection for cattle and pigs meloxicam

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

Each ml contains:

Active substance:

Meloxicam 5 mg

Clear yellow solution for injection.

Cattle ( calves and young cattle);

For use in acute respiratory infection with appropriate antibiotic therapy to reduce clinical signs in cattle.

For use in diarrhoea in combination with oral re-hydration therapy to reduce clinical signs in calves of over one week of age and young, non-lactating cattle.

For the relief of post-operative pain following dehorning in calves.

Pigs:

For use in non-infectious locomotor disorders to reduce the symptoms of lameness and inflammation. For the relief of post-operative pain associated with minor soft tissue surgery such as castration.

• 5. CONTRAINDI­CATIONS

Cattle:

Do not use in cattle suffering from impaired hepatic, cardiac or renal function and haemorrhagic disorders, or where there is evidence of ulcerogenic gastrointestinal lesions.

For the treatment of diarrhoea in cattle, do not use in animals of less than one week of age.

Pigs:

Do not use in pigs suffering from impaired hepatic, cardiac or renal function and haemorrhagic disorders, or where there is evidence of ulcerogenic gastrointestinal lesions.

Do not use in pigs less than 2 days old.

• 6. ADVERSE REACTIONS

Subcutaneous, intramuscular as well as intravenous administration is well tolerated; only a slight transient swelling at the injection site following subcutaneous administration was observed in less than 10 % of the cattle treated in clinical studies.

Anaphylactic reactions, which may be serious (including fatal), may occur in very rare cases and should be treated symptomatically.

The frequency of adverse reactions is defined using the following convention:

• – very common (more than 1 in 10 animals treated displaying adverse reactions)

• – 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

Cattle (calves and young cattle) and pigs

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

Cattle:

Single subcutaneous or intravenous injection at a dosage of 0.5 mg meloxicam/kg body weight (i.e. 10 ml/100 kg body weight) in combination with antibiotic therapy or with oral re-hydration therapy, as appropriate.

Pigs:

Locomotor disorders:

Single intramuscular injection at a dosage of 0.4 mg meloxicam/kg body weight (i.e. 2 ml/25 kg body weight). If required, a second administration of meloxicam can be given after 24 hours.

Reduction of post-operative pain:

Single intramuscular injection at a dosage of 0.4 mg meloxicam/kg body weight (i.e. 0.4 ml/5 kg body weight) before surgery.

Particular care should be taken with regard to the accuracy of dosing including the use of an appropriate dosing device and careful estimation of body weight.

As the vial should not be broached more than 50 times the user should select the most appropriate vial size according to the target species to be treated.

• 9. ADVICE ON CORRECT ADMINISTRATION

Avoid introduction of contamination during use.

Do not breach the vial more than 50 times.

• 10. WITHDRAWAL PERIOD(S)

Cattle (calves and young cattle): meat and offal: 15 days

Pigs: meat and offal: 5 days

• 11. SPECIAL STORAGE PRECAUTIONS

Keep out of the sight and reach of children.

This veterinary medicinal product does not require any special storage conditions.

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

Shelf-life after first opening the container: 28 days.

• 12. SPECIAL WARNING(S)

Special warnings for each target species:

Cattle:

Treatment of calves with Emdocam 20 minutes before dehorning reduces post-operative pain.

Emdocam alone will not provide adequate pain relief during the dehorning procedure.

To obtain pain relief during surgery co-medication with an appropriate anaesthetic/se­dative/analge­sic is needed.

To obtain the best possible pain-relieving effect post-surgery Emdocam should be administered 30 minutes before surgical intervention.

Pigs:

Treatment of piglets with Emdocam before castration reduces post-operative pain.

To obtain pain relief during surgery co-medication with an appropriate anaesthetic/se­dative/analge­sic is needed.

To obtain the best possible pain-relieving effect post-surgery Emdocam should be administered 30 minutes before surgical intervention.

Special precautions for use in animals:

If adverse reactions occur, treatment should be discontinued and the advice of a veterinarian should be sought.

Avoid use in any dehydrated, hypovolaemic or hypotensive animals which require parenteral rehydratation, as there may be a potential risk of renal toxicity.

During anaesthesia, monitoring and fluid therapy should be considered as standard practice.

Special precautions to be taken by the person administering the veterinary medicinal product to animals: Meloxicam may cause allergic reactions. People with known hypersensitivity to Non Steroidal AntiInflammatory Drugs (NSAIDs) should avoid contact with the veterinary medicinal product.

Accidental self-injection may give rise to pain. In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician.

This product can cause eye irritation. In case of contact with the eyes, immediately rinse thoroughly with water.

Pregnancy and lactation:

Cattle: Can be used during pregnancy.

Pigs: Can be used during pregnancy and lactation.

Interactions with other medicinal products and other forms of interaction:

Do not administer concurrently with glucocorticos­teroids, other non-steroidal anti-inflammatory drugs or with anticoagulant agents.

Overdose (symptoms, emergency procedures, antidotes):

In case of overdose symptomatic treatment should be initiated.

Incompatibili­ties:

In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products.

• 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 Medicines Agenc

• 15. OTHER INFORMATION

Pack sizes :

Cardboard box containing 1 vial of 50 ml Cardboard box containing 1 vial of 100 ml Cardboard box containing 1 vial of 250 ml

Not all pack sizes may be marketed.

For any information about this veterinary medicinal marketing authorisation holder.

België/Belgiqu­e/Belgien

Emdoka bvba

John Lijsenstraat 16

BE-2321 Hoogstraten

Tel : +32 3 315 04 26

Peny6nuKa EBnrapua

EHOCOEPA OAPM EOOfl yn.Wpun rarapuH N 50 BG rp. KocTUHÔpog 2230 Ten: + 359 885917017

Česká republika

BIOPHARM, Výzkumný ústav biofarmacie

product is available on the website of the European product, please contact the local representative of the

Lietuva

OU Zoovetvaru

Uusaru 5

EE-Saue 76505

Tel: +372 6 709 006

Luxembourg/Lu­xemburg

Emdoka bvba

John Lijsenstraat 16

BE-2321 Hoogstraten

Tel : +32 3 315 04 26

Magyarorszag

Meditrix Kft.

a veterinárních léčiv, a.s Pohoří – Chotouň 90 CZ-254 49 Jílové u Prahy

Ady E. u. 5 H-7020 Dunafoldvár Tel.: +36 75 542 940

Tel: +420 241 950 383

Danmark ChemVet dk A/S A.C. Illums Vej 6 DK-8600 Silkeborg Tlf: +45 8681 7522	Malta Emdoka bvba John Lijsenstraat 16 BE-2321 Hoogstraten Tel : +32 3 315 04 26
Deutschland WDT eG Siemensstr. 14 D-30827 Garbsen Tel: +49 5131 705 0	Nederland Emdoka bvba John Lijsenstraat 16 BE-2321 Hoogstraten Tel : +32 3 315 04 26
Eesti OÜ Zoovetvaru Uusaru 5 EE-Saue 76505 Tel: +372 6 709 006	Norge Emdoka bvba John Lijsenstraat 16 BE-2321 Hoogstraten Tel : +32 3 315 04 26
EMáSa FATRO-HELLAS SPLTD 2o %jl. 1 lAIANIA^AI IATQN GR-190 02 nAIANIA Tql: + 30 210 6644331 España Divasa-Farmavic S.A. Ctra. Sant Hipolit, km 71 E-08503 Gurb-Vic Tel: +34 93 886 01 00	Österreich Richter Pharma AG Feldgasse 19, A A-4600 Wels Tel: +43 7242 490 0 Polska Fatro Polska Sp. z o.o. ul. Bolonska 1 PL-55 040 Kobierzyce Tel.: +48 71 311 11 11
France Axience SAS Tour Essor – 14, rue Scandicci F-93500 Pantin Tél. +33 1 41 83 23 17	Portugal Divasa Farmavic de Portugal, Produtos e Equipamentos Veterinarios, Lda. Praceta Jaime C’ortecao N° 1 – R/C Loja Esq. 2625–170 Povoa de Santa Iria Tel: +351 219 739 130
Hrvatska Vet Consulting d.o.o. Matije Gupca 42 43500 Daruvar Tel: +385 43 440 527	Romania SC Altius SRL Str Iancu Capitanu nr 38 Ap 1 Sector 2, Bucuresti – RO Tel: + 40 021 310 88 80
Ireland Duggan Veterinary Supplies Ltd., Holycross, Thurles, Co Tipperary Ireland	Slovenija TPR d.o.o. Litostrojska cesta 44e, 1000 Ljubljana Slovenia Tel: +386 (0)1 505 5882

Tel: +353 (0) 504 43169

Ísland

Emdoka bvba

John Lijsenstraat 16

BE-2321 Hoogstraten

Tel : +32 3 315 04 26

Italia

Azienda Terapeutica Italiana A.T.I. s.r.l.

Via Emilia 285

I-40064 Ozzano dell’Emilia – Bologna

Tel: +39 051 6512711

Kúnpog

Enúpog Ziaupivíóng KépiKaXg At5

Asojcp. Ziaoívou 28, 1060 AsuKGJoía, Kúnpog Tql: +357 22 447464

Latvija

OÜ Zoovetvaru

Uusaru 5

EE-Saue 76505

Tel: +372 6 709 006

Slovenská republika

Emdoka bvba

John Lijsenstraat 16

BE-2321 Hoogstraten

Tel : +32 3 315 04 26

Suomi/Finland

Emdoka bvba

John Lijsenstraat 16

BE-2321 Hoogstraten

Tel : +32 3 315 04 26

Sverige

ChemVet dk A/S

A.C. Illums Vej 6

DK-8600 Silkeborg

Tel: +45 8681 7522

United Kingdom (Northern Ireland)

Duggan Veterinary Supplies Ltd.,

Holycross,

Thurles,

Co Tipperary

Ireland

Tel: +353 (0) 504 43169

PACKAGE LEAFLET:

Emdocam 5 mg/ml solution for injection for dogs and cats

• 1. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT

Marketing authorisation holder :

Emdoka bvba

John Lijsenstraat 16

2321 Hoogstraten

Belgium

Manufacturer responsible for the batch release :

Produlab Pharma B.V.

Forellenweg 16

4941 SJ Raamsdonksveer The Netherlands

• 2. NAME OF THE VETERINARY MEDICINAL PRODUCT

Emdocam 5 mg/ml solution for injection for dogs and cats meloxicam

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

Each ml contains:

Active substance:

Meloxicam 5 mg

Excipients:

Ethanol 150 mg

Clear yellow solution for injection.

• 4. INDICATION(S)

Dogs:

Alleviation of inflammation and pain in both acute and chronic musculo-skeletal disorders. Reduction of post-operative pain and inflammation following orthopaedic and soft tissue surgery.

Cats:

Reduction of post-operative pain after ovariohysterectomy and minor soft tissue surgery.

• 5. CONTRAINDI­CATIONS

Do not use in cases of hypersensitivity to the active substance or to any of the excipients.

Do not use in pregnant or lactating dogs and cats.

Do not use in dogs and cats suffering from gastrointestinal disorders such as irritation and haemorrhage, impaired hepatic, cardiac or renal function and haemorrhagic disorders. Do not use in dog and cats less than 6 weeks of age nor in cats of less than 2 kg.

Typical adverse reactions of Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) such as loss of appetite, vomiting, diarrhoea, faecal occult blood, lethargy and renal failure have rarely been reported.

Elevated liver enzymes have been reported in very rare cases.

Haemorrhagic diarrhoea, haematemesis and gastrointestinal ulceration have been reported in very rare cases. These side effects occur generally within the first treatment week and are in most cases transient and disappear following termination of the treatment but in very rare cases may be serious or fatal.

Anaphylactoid reactions may occur in very rare cases and should be treated symptomatically.

The frequency of adverse reactions is defined using the following convention:

• – very common (more than 1 in 10 animals treated displaying adverse reactions)

• – 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

Dogs, cats

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

Dogs:

Musculo-skeletal disorders:

Single subcutaneous injection at a dosage of 0.2 mg meloxicam/kg body weight (i.e. 0.4 ml/10 kg body weight).

Reduction of post-operative pain (over a period of 24 hours):

Single intravenous or subcutaneous injection at a dosage of 0.2 mg meloxicam/kg body weight (i.e. 0.4 ml/10 kg body weight) before surgery, for example at the time of induction of anaesthesia.

Cats:

Reduction of post-operative pain after ovariohysterectomy and minor soft tissue surgery:

Single subcutaneous injection at a dosage of 0.3 mg meloxicam/kg body weight (i.e. 0.06 ml/kg body weight) before surgery, for example at the time of induction of anaesthesia.

As the vial should not be broached more than 50 times the user should select the most appropriate vial size according to the target species to be treated.

• 9. ADVICE ON CORRECT ADMINISTRATION

Avoid introduction of contamination during use.

• 10. WITHDRAWAL PERIOD(S)

Not applicable.

• 11. SPECIAL STORAGE PRECAUTIONS

Keep out of the sight and reach of children.

This veterinary medicinal product does not require any special storage conditions.

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

Shelf-life after first opening the container: 28 days.

• 12. SPECIAL WARNING(S)

Special warnings for each target species:

None.

Special precautions for use in animals:

If adverse reactions occur, treatment should be discontinued and the advice of a veterinarian should be sought.

Avoid use in any dehydrated, hypovolaemic or hypotensive animals which require parenteral rehydratation, as there may be a potential risk of renal toxicity.

During anaesthesia, monitoring and fluid therapy should be considered as standard practice. Any oral follow-up therapy using meloxicam or other NSAIDs should not be administered in cats, as appropriate dosage regimens for such follow-up treatments have not been established.

Special precautions to be taken by the person administering the veterinary medicinal product to animals: Meloxicam may cause allergic reactions. People with known hypersensitivity to Non Steroidal AntiInflammatory Drugs (NSAIDs) should avoid contact with the veterinary medicinal product.

Accidental self-injection may give rise to pain. In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician.

This product can cause eye irritation. In case of contact with the eyes, immediately rinse thoroughly with water.

Pregnancy and lactation:

Do not use in pregnant or lactating dogs or cats.

Interactions with other medicinal products and other forms of interaction:

Other NSAIDs, diuretics, anticoagulants, aminoglycoside antibiotics and substances with high protein binding may compete for binding and thus lead to toxic effects. Emdocam must not be administered in conjunction with other NSAIDs or glucocorticos­teroids. Concurrent administration of potential nephrotoxic drugs should be avoided. In animals at anaesthetic risk (e.g. aged animals) intravenous or subcutaneaous fluid therapy during anaesthesia should be taken into consideration. When anaesthesia and NSAID are concomitantly administered, a risk for renal function cannot be excluded.

Pre-treatment with anti-inflammatory substances may result in additional or increased adverse effects and accordingly a treatment-free period with such veterinary medicinal products should be observed for at least 24 hours before commencement of treatment. The treatment-free period, however, should take into account the pharmacological properties of the products used previously.

Overdose (symptoms, emergency procedures, antidotes):

In case of overdose symptomatic treatment should be initiated.

Incompatibili­ties:

In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products.

• 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 Agenc

• 15. OTHER INFORMATION