ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
1.
Melovem 5 mg/ml solution for injection for cattle and pigs
2.
Each ml contains:
Active substance:
Meloxicam 5 mg
Excipient(s):
Benzyl alcohol 50 mg
For a full list of excipients, see section 6.1.
3.
Clear, greenish yellow solution for injection.
4.1 Targetspecies
Cattle (calves and young cattle) and pigs.
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.
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.
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.
Do not use in pigs less than 2 days old.
Treatment of piglets with Melovem before castration reduces post operative pain. To obtain pain relief
during surgery co-medication with an appropriate anaesthetic/sedative is needed.
To obtain the best possible pain relieving effect post surgery Melovem should be administered 30
minutes before surgical intervention.
2
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.
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 NSAID should
avoid contact with the veterinary medicinal product.
In case of accidental self-injection, seek medical advice immediately and show the package leaflet or
the label to the physician.
Transient swelling at the injection site was commonly reported in clinical studies following
subcutaneous administration in cattle. Injection site swelling may be painful.
Transient swelling at the injection site was observed in clinical studies following intramuscular
administration in pigs.
In very rare cases, anaphylactoid reactions may occur and should be treated symptomatically.
Cattle
:
Can be used during pregnancy.
For lactating animals see section 4.11.
Pigs
:
Can be used during pregnancy and lactation.
Do not administer concurrently with glucocorticosteroids, other non-steroidal anti-inflammatory drugs
or with anti-coagulant agents.
Cattle
:
Single subcutaneous injection at a dosage of 0.5 mg meloxicam/kg body weight (i.e. 10.0 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. 2.0 ml/25 kg
body weight). If required, a second administration of meloxicam can be given after 24 hours.
It is recommended to administer the second injection at a different site since local tolerance has been
assessed after single injection only.
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.
3
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.
Avoid introduction of contamination during use.
In the case of overdosage symptomatic treatment should be initiated.
4.11 Withdrawalperiods
Cattle
:
Meat and offal: 15 days.
Not permitted for use in lactating animals producing milk for human consumption.
Pigs
:
Meat and offal: 5 days.
5.
Pharmacotherapeutic group: Antiinflammatory and antirheumatic products, non-steroids (oxicams)
ATCvet code: QM01AC06.
5.1 Pharmacodynamicproperties
Meloxicam is a non-steroidal anti-inflammatory drug (NSAID) of the oxicam class which acts by
inhibition of prostaglandin synthesis, thereby exerting anti-inflammatory, anti-exudative, analgesic
and antipyretic properties. Meloxicam also has anti-endotoxic properties because it has been shown to
inhibit production of thromboxane B
2
induced by E. coli endotoxin administration in calves and pigs.
5.2 Pharmacokinetic particulars
Absorption
After a single subcutaneous dose of 0.5 mg meloxicam/kg, C
max
values of 2.1 μg/ml were reached after
7.7 hours in young cattle.
Following single intramuscular doses of 0.4 mg meloxicam/kg, a C
max
values of 1.1 to 1.5 μg/ml were
reached within 1 hour in pigs.
Distribution
More than 98 % of meloxicam is bound to plasma proteins. The highest meloxicam concentrations are
to be found in liver and kidney. Comparatively low concentrations are detectable in skeletal muscle
and fat.
Metabolism
Meloxicam is predominantly found in plasma. In cattle, meloxicam is also a major excretion product
in milk and bile whereas urine contains only traces of the parent compound. In pigs, bile and urine
contain only traces of the parent compound. Meloxicam is metabolised to an alcohol, an acid
derivative and to several polar metabolites. All major metabolites have been shown to be
pharmacologically inactive.
Elimination
Meloxicam is eliminated with a half-life of 26 hours after subcutaneous injection in young cattle.
In pigs, after intramuscular administration, the mean plasma biological elimination half-life is
approximately 2.5 hours.
4
Approximately 50 % of the administered dose is eliminated via urine and the remainder via faeces.
6.
6.1 List of excipients
Benzyl alcohol
Hydrochloric acid
Sodium chloride
Macrogol 400
Macrogol 1500
Meglumine
Water for injection
6.2 Incompatibilities
In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other
veterinary medicinal products.
6.3 Shelf life
Shelf life of the veterinary medicinal product as packaged for sale: 2 years.
Shelf life after first opening the immediate packaging: 28 days.
6.4. Special precautions for storage
Keep injection vial in the outer carton in order to protect from light.
This veterinary medicinal product does not require any special temperature storage conditions.
6.5 Nature and composition of immediate packaging
Cardboard box with 1 colourless, type I glass injection vial of 100 ml, which is closed with a
bromobutyl rubber stopper and sealed with an aluminium cap.
6.6
Special precautions for the disposal of unused veterinary medicinal products or waste
materials derived from the use of such products
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal
products should be disposed of in accordance with local requirements.
7.
Dopharma Research B.V.
Zalmweg 24
4941 VX Raamsdonksveer The Netherlands
8. MARKETING AUTHORISATION NUMBER
EU/2/09/098/001
5
7 July 2009
08/04/2010
Detailed information on this veterinary medicinal product is available on the website of the European
Medicines Agency
http://www.ema.europa.eu
/.
PROHIBITION OF SALE, SUPPLY AND/OR USE
Not applicable.
6
ANNEX II
A. THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR
BATCH RELEASE
B. CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION
REGARDING SUPPLY OR USE
C. CONDITIONS OR RESTRICTIONS OF THE MARKETING
AUTHORISATION WITH REGARD TO SAFE AND EFFECTIVE USE
D. STATEMENT OF THE MRLs
7
A. MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH
RELEASE
Name and address of the manufacturer responsible for batch release
Dopharma B.V.
Zalmweg 24
4941 VX Raamsdoonksveer
The Netherlands
B. CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION
REGARDING SUPPLY OR USE
To be supplied only on veterinary prescription.
C. CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION WITH
REGARD TO THE SAFE AND EFFECTIVE USE OF THE PRODUCT
Not applicable
D. STATEMENT OF THE MRLs
The Committee for Veterinary Medicinal Products has recommended the inclusion of meloxicam in
Annex I of Council Regulation (EEC) No 2377/90 in accordance with the following table:
Pharmacologically
active substance(s)
Marker residue
Animal
species
MRLs
Target tissues
Other
provisions
Meloxicam
Meloxicam
Bovine
20 µg/kg
65 µg/kg
65 µg/kg
15 µg/kg
Muscle
Liver
Kidney
Milk
Porcine
20 µg/kg
65 µg/kg
65 µg/kg
Muscle
Liver
Kidney
All other constituents of Melovem are included in Annex II of Council Regulation (EEC) No 2377/90
or are considered as not falling within the scope of the Regulation.
8
ANNEX III
LABELLING AND PACKAGE LEAFLET
9
A. LABELLING
10
PARTICULARS TO APPEAR ON THE OUTER PACKAGE
Cardboard box
1.
Melovem 5 mg/ml solution for injection for cattle and pigs.
Meloxicam
2.
STATEMENT OF ACTIVE AND OTHER SUBSTANCES
Each ml contains:
Active substance:
Meloxicam 5 mg
Excipients:
Benzyl alcohol 50 mg
3.
Solution for injection
4.
PACKAGE SIZE
100 ml
5.
Cattle (calves and young cattle) and pigs
6.
Cattle:
Acute respiratory infection.
Diarrhoea in calves of over one week of age and young, non-lactating cattle.
Pigs:
Non-infectious locomotor disorders.
Post operative pain associated with minor soft tissue surgery such as castration.
7.
METHOD AND ROUTE(S) OF ADMINISTRATION
Read the package leaflet before use.
8.
Cattle: meat and offal: 15 days.
11
Not permitted for use in lactating animals producing milk for human consumption.
Pigs: meat and offal: 5 days.
9.
SPECIAL WARNING(S), IF NECESSARY
10. EXPIRY DATE
EXP {month/year}
Once broached, use within 28 days
11. SPECIAL STORAGE CONDITIONS
Keep the injection vial in the outer carton in order to protect from light.
12. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS OR
WASTE MATERIALS, IF ANY
Dispose of waste material 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 REACH AND SIGHT OF CHILDREN”
Keep out of the reach and sight of children.
Dopharma Research B.V.
Zalmweg 24
4941 VX Raamsdonksveer - NL
EU/2/09/098/001
17. MANUFACTURER’S BATCH NUMBER
Lot: {number}
12
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE
Glass vial
1.
Melovem 5 mg/ml solution for injection for cattle and pigs.
Meloxicam
2.
STATEMENT OF ACTIVE SUBSTANCE
Each ml contains:
Meloxicam 5 mg
Benzyl alcohol 50 mg
3.
Solution for injection
4.
PACKAGE SIZE
100 ml
5.
Cattle (calves and young cattle) and pigs
6.
Read the package leaflet before use.
7.
METHOD(S) AND ROUTES OF ADMINISTRATION
Cattle: subcutaneous injection.
Pigs: intramuscular injection.
Read the package leaflet before use.
8.
Cattle: meat and offal: 15 days.
Not permitted for use in lactating animals producing milk for human consumption.
Pigs: meat and offal: 5 days.
13
9.
SPECIAL WARNING(S), IF NECESSARY
10. EXPIRY DATE
EXP: {month/year}
Once broached, use within 28 days.
11. SPECIAL STORAGE CONDITIONS
Keep the injection vial in the outer carton in order to protect from light.
12. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS OR
WASTE MATERIALS, IF ANY
Dispose of waste material 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 REACH AND SIGHT OF CHILDREN”
Keep out of the reach and sight of children.
Dopharma Research B.V.
Zalmweg 24
4941 VX Raamsdonksveer - NL
EU/2/09/098/001
17. MANUFACTURER’S BATCH NUMBER
Lot: {number}
14
B. PACKAGE LEAFLET
15
PACKAGE LEAFLET
Melovem 5 mg/ml solution for injection for cattle and pigs
1.
THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH
RELEASE, IF DIFFERENT
Marketing authorisation holder:
Dopharma Research B.V.
Zalmweg 24
4941 VX Raamsdonksveer The Netherlands
Manufacturer responsible for the batch release:
Dopharma B.V.
Zalmweg 24
4941 VX Raamsdonksveer The Netherlands
2.
Melovem 5 mg/ml solution for injection for cattle and pigs
Meloxicam
3. STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
Each ml contains:
Active substance:
Meloxicam 5 mg
Excipient(s):
Benzyl alcohol 50 mg
A clear, greenish yellow solution.
4.
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.
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.
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.
16
For the treatment of diarrhoea in cattle, do not use in animals of less than one week of age.
Do not use in pigs less than 2 days old.
6.
ADVERSE REACTIONS
Transient swelling at the injection site was commonly reported in clinical studies following
subcutaneous administration in cattle. Injection site swelling may be painful.
Transient swelling at the injection site was observed in clinical studies following intramuscular
administration in pigs.
In very rare cases, anaphylactoid reactions may occur and should be treated symptomatically.
If you notice any serious effects or other effects not mentioned in this leaflet, please inform your
veterinary surgeon.
7.
TARGET SPECIES
Cattle (calves and young cattle) and pigs.
8.
DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD(S) OF
ADMINISTRATION
Cattle:
Single subcutaneous injection at a dosage of 0.5 mg meloxicam/kg body weight (i.e. 10.0 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. 2.0 ml/25 kg
body weight).
If required, a second administration of meloxicam can be given after 24 hours. It is recommended to
administer the second injection at a different site since local tolerance has been assessed after single
injection only.
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.
9.
ADVICE ON CORRECT ADMINISTRATION
Avoid introduction of contamination during use.
10. WITHDRAWAL PERIOD
Cattle: meat and offal: 15 days.
Not permitted for use in lactating animals producing milk for human consumption.
Pigs: meat and offal: 5 days.
17
11. SPECIAL STORAGE PRECAUTIONS
Keep out of the reach and sight of children.
Keep injection vial in the outer carton in order to protect from light.
This veterinary medicinal product does not require any special temperature storage conditions.
Shelf life after first opening the container: 28 days.
Do not use after the expiry date (EXP) stated on the carton and bottle.
12. SPECIAL WARNINGS
Treatment of piglets with Melovem before castration reduces post operative pain. To obtain pain relief
during surgery co-medication with an appropriate anaesthetic/sedative is needed.
To obtain the best possible pain relieving effect post surgery Melovem should be administered 30
minutes before surgical intervention.
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.
Precautions to be taken by the person administering the product
Accidental self-injection may give rise to pain. People with known hypersensitivity to Non-Steroidal
Anti-Inflammatory 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.
Use during pregnancy and lactation
Cattle: Can be used during pregnancy.
Pigs: Can be used during pregnancy and lactation.
Interactions
Do not administer concurrently with glucocorticosteroids, other non-steroidal anti-inflammatory drugs
or with anti-coagulant agents.
13. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS OR
WASTE MATERIALS, IF ANY
Waste materials should be disposed of in accordance with local requirements.
14. DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED
08/04/2010
Detailed information on this veterinary medicinal product is available on the website of the European
Medicines Agency
http://www.ema.europa.eu
/.
18
15. OTHER INFORMATION
Cardboard box with 1 colourless type I glass injection vial of 100 ml, which is closed with a
bromobutyl rubber stopper and sealed with an aluminium cap.
19
Source: European Medicines Agency
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