ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
Novem 5 mg/ml solution for injection for cattle and pigs
One ml contains:
Active substance:
Meloxicam
5 mg
Excipient:
Ethanol
150 mg
For a full list of excipients, see section 6.1.
Solution for injection.
Clear yellow solution.
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 Novem 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 Novem should be administered 30
2/35
minutes before surgical intervention.
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 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 the package leaflet or
the label to the physician.
Subcutaneous and intramuscular 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.
In very rare cases anaphylactoid reactions may occur and should be treated symptomatically.
Cattle:
Can be used during pregnancy.
Pigs:
Do not administer concurrently with glucocorticosteroids, other non-steroidal anti-inflammatory drugs
or with anticoagulant 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.
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.
Avoid introduction of contamination during use.
3/35
Can be used during pregnancy and lactation.
In case of overdose symptomatic treatment should be initiated.
4.11 Withdrawal periods
Cattle:
Meat and offal: 15 days
Pigs:
Pharmacotherapeutic group: Antiinflammatory and antirheumatic products, non-steroids (oxicams)
ATCvet code:
QM01AC06
5.1 Pharmacodynamic properties
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
value of 1.1 to 1.5 µg/ml was
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 elimination half-life is approximately
2.5 hours.
Approximately 50 % of the administered dose is eliminated via urine and the remainder via faeces.
6.1 List of excipients
- Ethanol
- Poloxamer 188
4/35
Meat and offal: 5 days
- Sodium chloride
- Glycine
- Sodium hydroxide
- Glycofurol
- Meglumine
- Water for injection
6.2 Incompatibilities
None known.
6.3 Shelf life
Shelf-life of the veterinary medicinal product as packaged for sale:
3 years
Shelf-life after first opening the immediate packaging:
28 days
6.4 Special precautions for storage
This veterinary medicinal product does not require any special storage conditions.
6.5 Nature and composition of immediate packaging
Cardboard box with 1 or 12 colourless glass injection vial(s) of 20 ml, 50 ml or 100 ml, closed with a
rubber stopper and sealed with an aluminium cap.
Not all pack sizes may be marketed.
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.
Boehringer Ingelheim Vetmedica GmbH
55216 Ingelheim/Rhein
Germany
8. MARKETING AUTHORISATION NUMBERS
EU/2/04/042/007 20 ml
EU/2/04/042/009 50 ml
EU/2/04/042/001 100 ml
EU/2/04/042/008 12 x 20 ml
EU/2/04/042/010 12 x 50 ml
EU/2/04/042/002 12 x 100 ml
Date of first authorisation:
02.03.2004
5/35
Date of last renewal:
13.01.2009
10.2010
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.
6/35
Novem 20 mg/ml solution for injection for cattle and pigs
One ml contains:
Active substance:
Meloxicam
20 mg
Excipient:
Ethanol
150 mg
For a full list of excipients, see section 6.1.
Solution for injection.
Clear yellow solution.
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.
For adjunctive therapy in the treatment of acute mastitis, in combination with antibiotic therapy.
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.
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.
None.
7/35
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 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 the package leaflet or
the label to the physician.
Subcutaneous and intramuscular 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.
In very rare cases anaphylactoid reactions may occur and should be treated symptomatically.
Can be used during pregnancy and lactation.
Do not administer concurrently with glucocorticosteroids, other non-steroidal anti-inflammatory drugs
or with anticoagulant agents.
Cattle:
Single subcutaneous injection at a dosage 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 dosage of 0.4 mg meloxicam/kg body weight (i.e. 2.0 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.
Avoid introduction of contamination during use.
In case of overdose, symptomatic treatment should be initiated.
4.11 Withdrawal periods
Cattle:
Meat and offal: 15 days; Milk: 5 days
Pigs:
Meat and offal: 5 days
8/35
Pharmacotherapeutic group: Antiinflammatory and antirheumatic products, non-steroids (oxicams)
ATCvet code:
QM01AC06
5.1 Pharmacodynamic properties
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 effects. It reduces leukocyte infiltration into the inflamed tissue. To a minor extent it
also inhibits collagen-induced thrombocyte aggregation. 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, lactating cows 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 and 2.7 µg/ml were
reached after 7.7 hours and 4 hours in young cattle and lactating cows, respectively.
After two intramuscular doses of 0.4 mg meloxicam/kg, a C
max
value of 1.9 µg/ml was reached after
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 and 17.5 hours after subcutaneous injection in
young cattle and lactating cows, respectively.
In pigs, after intramuscular administration the mean plasma elimination half-life is approximately
2.5 hours.
Approximately 50 % of the administered dose is eliminated via urine and the remainder via faeces.
6.1 List of excipients
-
Ethanol
-
Poloxamer 188
-
Macrogol 300
-
Glycine
-
Disodium edetate
-
Sodium hydroxide
-
Hydrochloric acid
-
Meglumine
9/35
-
Water for injection
6.2 Incompatibilities
None known.
6.3 Shelf life
Shelf-life of the veterinary medicinal product as packaged for sale (20 ml, 50 ml or 100 ml vials): 3 years
Shelf-life of the veterinary medicinal product as packaged for sale (250 ml vials):
2 years
Shelf-life after first opening the immediate packaging:
28 days
6.4 Special precautions for storage
This veterinary medicinal product does not require any special storage conditions.
6.5 Nature and composition of immediate packaging
Cardboard box with 1 colourless glass injection vial containing 20 ml, 50 ml, 100 ml or 250 ml.
Each vial is closed with a rubber stopper and sealed with an aluminium cap.
Not all pack sizes may be marketed.
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.
Boehringer Ingelheim Vetmedica GmbH
55216 Ingelheim/Rhein
Germany
8. MARKETING AUTHORISATION NUMBERS
EU/2/04/042/005 1 x 20 ml
EU/2/04/042/003 1 x 50 ml
EU/2/04/042/004 1 x 100 ml
EU/2/04/042/006 1 x 250 ml
Date of first authorisation:
02.03.2004
Date of last renewal:
13.01.2009
10.2010
Detailed information on this veterinary medicinal product is available on the website of the European
Medicines Agency
http://www.ema.europa.eu
/.
10/35
PROHIBITION OF SALE, SUPPLY AND/OR USE
Not applicable.
11/35
ANNEX II
A.
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
12/35
Novem 5 mg/ml solution for injection for cattle and pigs
A. MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH
RELEASE
Name and address of the manufacturer responsible for batch release
Labiana Life Sciences S.A.
Venus, 26
Can Parellada Industrial
08228 Terrassa
Spain
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
Meloxicam is an allowed substance as described in Table 1 of the annex to Commission Regulation
(EU) No 37/2010:
Pharmacologically
active substance(s)
Marker
residue
Animal
species
MRLs Target
tissues
Other
provisions
Therapeutic
classification
Meloxicam
Meloxicam
Bovine,
caprine,
porcine,
rabbit,
Equidae
20 µg/kg
65 µg/kg
65 µg/kg
Muscle
Liver
Kidney
No entry
Anti-
inflammatory
agents/Non-
steroidal anti-
inflammatory
agents
Bovine,
caprine
15 µg/kg Milk
The excipients listed in section 6.1 of the SPC are either allowed substances for which Table 1 of the
annex to Commission Regulation (EU) No 37/2010 indicates that no MRLs are required or are
considered as not falling within the scope of Regulation (EC) No 470/2009 when used as in this
product.
13/35
Novem 20 mg/ml solution for injection for cattle and pigs
A. MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH
RELEASE
Name and address of the manufacturer responsible for batch release
Labiana Life Sciences S.A.
Venus, 26
Can Parellada Industrial
08228 Terrassa
Spain
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
Meloxicam is an allowed substance as described in Table 1 of the annex to Commission Regulation
(EU) No 37/2010:
Pharmaco-
logically
active
substance
Marker
residue
Animal
species
MRL Target
tissues
Other
provisions
Therapeutic
classification
Meloxicam Meloxicam
Bovine,
caprine,
porcine,
rabbit,
Equidae
20 μg/kg
65 μg/kg
65 μg/kg
Muscle
Liver
Kidney
No entry Anti-inflammatory
agents/Non-steroidal
anti-inflammatory
agents
Bovine,
caprine
15 μg/kg Milk
The excipients listed in section 6.1 of the SPC are either allowed substances for which Table 1 of the
annex to Commission Regulation (EU) No 37/2010 indicates that no MRLs are required or are
considered as not falling within the scope of Regulation (EC) No 470/2009 when used as in this
product.
14/35
ANNEX III
LABELLING AND PACKAGE LEAFLET
15/35
A. LABELLING
16/35
PARTICULARS TO APPEAR ON THE OUTER PACKAGE
Novem 5 mg/ml solution for injection for cattle and pigs
Meloxicam
2. STATEMENT OF ACTIVE AND OTHER SUBSTANCES
Meloxicam
5 mg/ml
Solution for injection
4. PACKAGE SIZE
20 ml
50 ml
100 ml
12 x 20 ml
12 x 50 ml
12 x 100 ml
5. TARGET SPECIES
Cattle (calves and young cattle) and pigs
6. INDICATION(S)
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
Cattle:
Single subcutaneous injection.
Pigs:
Single intramuscular injection. If required, a second administration can be given after 24 hours.
Single intramuscular injection before surgery.
17/35
Take care of accurate dosing, use of appropriate dosing device and estimation of body weight.
Read the package leaflet before use.
8. WITHDRAWAL PERIOD
Cattle:
meat and offal: 15 days
Pigs:
meat and offal: 5 days
9. SPECIAL WARNING(S), IF NECESSARY
Read the package leaflet before use.
10. EXPIRY DATE
EXP {month/year}
Shelf-life of broached vial: 28 days.
11. SPECIAL STORAGE CONDITIONS
Read the package leaflet before use.
12. SPECIFIC PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR
WASTE MATERIALS, IF ANY
Read the package leaflet before use.
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 REACH AND SIGHT OF CHILDREN"
Keep out of the reach and sight of children.
Boehringer Ingelheim Vetmedica GmbH
55216 Ingelheim/Rhein
Germany
16. MARKETING AUTHORISATION NUMBERS
EU/2/04/042/007 20 ml
EU/2/04/042/009 50 ml
18/35
EU/2/04/042/001 100 ml
EU/2/04/042/008 12 x 20 ml
EU/2/04/042/010 12 x 50 ml
EU/2/04/042/002 12 x 100 ml
17. MANUFACTURER´S BATCH NUMBER
Lot {number}
19/35
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE
Novem 5 mg/ml solution for injection for cattle and pigs
Meloxicam
2. STATEMENT OF ACTIVE AND OTHER SUBSTANCES
Meloxicam
5 mg/ml
solution for injection
4. PACKAGE SIZE
100 ml
5. TARGET SPECIES
Cattle (calves and young cattle) and pigs
6. INDICATION(S)
Read the package leaflet before use.
7. METHOD AND ROUTE(S) OF ADMINISTRATION
Cattle
: SC injection.
Pigs:
IM injection.
Read the package leaflet before use.
8. WITHDRAWAL PERIOD
Cattle:
meat and offal: 15 days
Pigs:
meat and offal: 5 days
9. SPECIAL WARNING(S), IF NECESSARY
Read the package leaflet before use.
20/35
10. EXPIRY DATE
EXP {month/year}
Shelf-life of broached vial: 28 days.
Once broached, use by...
11. SPECIAL STORAGE CONDITIONS
Read the package leaflet before use.
12. SPECIFIC PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS OR
WASTE MATERIALS, IF ANY
Read the package leaflet before use.
13. THE WORDS “FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR
RESTRICTIONS REGARDING SUPPLY AND USE, if applicable
For animal treatment only.
14. THE WORDS "KEEP OUT OF REACH AND SIGHT OF CHILDREN"
Read the package leaflet before use.
Read the package leaflet before use.
16. MARKETING AUTHORISATION NUMBERS
EU/2/04/042/007 20 ml
EU/2/04/042/009 50 ml
EU/2/04/042/001 100 ml
EU/2/04/042/008 12 x 20 ml
EU/2/04/042/010 12 x 50 ml
EU/2/04/042/002 12 x 100 ml
17. MANUFACTURER´S BATCH NUMBER
Lot {number}
21/35
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
Novem 5 mg/ml solution for injection for cattle and pigs
Meloxicam
2. QUANITITY OF THE ACTIVE SUBSTANCE(S)
Meloxicam 5 mg/ml
3. CONTENTS BY WEIGHT, BY VOLUME OR BY NUMBER OF DOSES
20 ml
50 ml
4. ROUTE(S) OF ADMINISTRATION
Cattle:
SC
Pigs:
IM
5. WITHDRAWAL PERIOD
Cattle:
meat and offal: 15 days
Pigs:
meat and offal: 5 days
6. BATCH NUMBER
Lot {number}
7. EXPIRY DATE
EXP {month/year}
Shelf-life of broached vial: 28 days.
Once broached, use by….
8. THE WORDS "FOR ANIMAL TREATMENT ONLY"
For animal treatment only.
22/35
PARTICULARS TO APPEAR ON THE OUTER PACKAGE
Novem 20 mg/ml solution for injection for cattle and pigs
Meloxicam
2. STATEMENT OF ACTIVE AND OTHER SUBSTANCES
Meloxicam 20 mg/ml
Solution for injection
4. PACKAGE SIZE(S)
1 x 20 ml
1 x 50 ml
1 x 100 ml
1 x 250 ml
5. TARGET SPECIES
Cattle and pigs
6. INDICATION(S)
Cattle:
Acute respiratory infection.
Diarrhoea in calves of over one week of age and young, non-lactating cattle.
Acute mastitis.
Pigs:
Non-infectious locomotor disorders.
Puerperal septicaemia and toxaemia (MMA syndrome) with antibiotic therapy.
7. METHOD AND ROUTE(S) OF ADMINISTRATION
Cattle:
Single SC injection.
Pigs:
Single IM injection. If required, a second administration can be given after 24 hours.
Read the package leaflet before use.
23/35
8. WITHDRAWAL PERIOD
Cattle:
meat and offal: 15 days; milk: 5 days
Pigs:
meat and offal: 5 days
9. SPECIAL WARNING(S), IF NECESSARY
Read the package leaflet before use.
10. EXPIRY DATE
EXP {month/year}
Shelf-life of broached vial: 28 days.
11. SPECIAL STORAGE CONDITIONS
Read the package leaflet before use.
12. SPECIFIC PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS OR
WASTE MATERIALS, IF ANY
Read the package leaflet before use
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 REACH AND SIGHT OF CHILDREN"
Keep out of the reach and sight of children.
Boehringer Ingelheim Vetmedica GmbH
55216 Ingelheim/Rhein
Germany
16. MARKETING AUTHORISATION NUMBERS
EU/2/04/042/005 1 x 20 ml
EU/2/04/042/003 1 x 50 ml
EU/2/04/042/004 1 x 100 ml
EU/2/04/042/006 1 x 250 ml
24/35
17. MANUFACTURER´S BATCH NUMBER
Lot {number}
25/35
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE
Novem 20 mg/ml solution for injection for cattle and pigs
Meloxicam
2. STATEMENT OF ACTIVE AND OTHER SUBSTANCES
Meloxicam 20 mg/ml
Solution for injection
4. PACKAGE SIZE(S)
50 ml
100 ml
250 ml
5. TARGET SPECIES
Cattle and pigs
6. INDICATION(S)
Read the package leaflet before use.
7. METHOD AND ROUTE(S) OF ADMINISTRATION
Cattle:
SC injection.
Pigs:
IM injection.
8. WITHDRAWAL PERIOD
Cattle:
meat and offal: 15 days; milk: 5 days
Pigs:
meat and offal: 5 days
9. SPECIAL WARNING(S), IF NECESSARY
Read the package leaflet before use.
26/35
10. EXPIRY DATE
EXP {month/year}
Shelf-life of broached vial: 28 days.
Once broached, use by…
11. SPECIAL STORAGE CONDITIONS
Read the package leaflet before use.
12. SPECIFIC PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS OR
WASTE MATERIALS, IF ANY
Read the package leaflet before use
13. THE WORDS "FOR ANIMAL TREATMENT ONLY" AND CONDITIONS OR
RESTRICTIONS REGARDING SUPPLY AND USE, if applicable
For animal treatment only.
14. THE WORDS "KEEP OUT OF REACH AND SIGHT OF CHILDREN"
Read the package leaflet before use.
Boehringer Ingelheim Vetmedica GmbH
Germany
16. MARKETING AUTHORISATION NUMBERS
EU/2/04/042/005 1 x 20 ml
EU/2/04/042/003 1 x 50 ml
EU/2/04/042/004 1 x 100 ml
EU/2/04/042/006 1 x 250 ml
17. MANUFACTURER´S BATCH NUMBER
Lot {number}
27/35
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
Novem 20 mg/ml solution for injection for cattle and pigs
Meloxicam
2. QUANITITY OF THE ACTIVE SUBSTANCE(S)
Meloxicam 20 mg/ml
3. CONTENTS BY WEIGHT, BY VOLUME OR BY NUMBER OF DOSES
20 ml
4. ROUTE(S) OF ADMINISTRATION
Cattle:
SC
Pigs:
IM
5. WITHDRAWAL PERIOD
Cattle:
meat and offal: 15 days; milk: 5 days
Pigs:
meat and offal: 5 days
6. BATCH NUMBER
Lot {number}
7. EXPIRY DATE
EXP {month/year}
Shelf-life of broached vial: 28 days.
Once broached, use by…
8. THE WORDS "FOR ANIMAL TREATMENT ONLY"
For animal treatment only.
28/35
B. PACKAGE LEAFLET
29/35
PACKAGE LEAFLET FOR:
Novem 5 mg/ml solution for injection for cattle and pigs
THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH
RELEASE, IF DIFFERENT
Marketing authorisation holder
Boehringer Ingelheim Vetmedica GmbH
55216 Ingelheim/Rhein
Germany
Manufacturer
Labiana Life Sciences S.A.
Venus, 26
Can Parellada Industrial
08228 Terrassa
Spain
Novem 5 mg/ml solution for injection for cattle and pigs
Meloxicam
3. STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENTS
One ml contains:
Meloxicam 5 mg
Ethanol
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.
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
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.
30/35
150 mg
Subcutaneous and intramuscular injection 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.
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 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.
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
Pigs:
meat and offal: 5 days
11. SPECIAL STORAGE PRECAUTIONS
Keep out of the reach and sight of children.
This veterinary medicinal product does not require any special storage conditions.
Shelf-life after first opening the container: 28 days.
Do not use after the expiry date stated on the carton and bottle after EXP.
31/35
12. SPECIAL WARNING(S)
Treatment of piglets with Novem 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 Novem 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 anticoagulant agents.
Overdose
In case of overdose symptomatic treatment should be initiated.
13. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE
MATERIALS, IF ANY
Any unused medicines or waste materials should not be disposed of via wastewater or household
waste but in accordance with local requirements. These measures should help to protect the
environment.
14. DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED
10.2010
Detailed information on this veterinary medicinal product is available on the website of the European
Medicines Agency
http://www.ema.europa.eu/
.
15. OTHER INFORMATION
Cardboard box with 1 or 12 colourless glass injection vial(s) of 20 ml, 50 ml or 100 ml.
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.
32/35
PACKAGE LEAFLET FOR:
Novem 20 mg/ml solution for injection for cattle and pigs
THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH
RELEASE, IF DIFFERENT
Marketing authorisation holder
Boehringer Ingelheim Vetmedica GmbH
55216 Ingelheim/Rhein
Germany
Manufacturer
Labiana Life Sciences S.A.
Venus, 26
Can Parellada Industrial
08228 Terrassa
Spain
Novem 20 mg/ml solution for injection for cattle and pigs
Meloxicam
3. STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENTS
One ml contains:
Meloxicam 20 mg
Ethanol
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.
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.
5. CONTRAINDICATIONS
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.
33/35
150 mg
For the treatment of diarrhoea in cattle, do not use in animals of less than one week of age.
Subcutaneous and intramuscular 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.
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 and pigs
8. DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION
Cattle:
Single subcutaneous injection at a dosage 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 dosage of 0.4 mg meloxicam/kg body weight (i.e. 2.0 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.
9. ADVICE ON CORRECT ADMINISTRATION
Avoid introduction of contamination during use.
10. WITHDRAWAL PERIODS
Cattle:
meat and offal: 15 days; milk: 5 days
Pigs:
11. SPECIAL STORAGE PRECAUTIONS
Keep out of the reach and sight of children.
This veterinary medicinal product does not require any special storage conditions.
Shelf-life after first opening the container: 28 days.
Do not use after the expiry date stated on the carton and vial after EXP.
12. SPECIAL WARNING(S)
Precautions for use in animals
If adverse reactions occur, treatment should be discontinued and the advice of a veterinarian should be
sought.
34/35
meat and offal: 5 days
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
Can be used during pregnancy and lactation.
Interactions
Do not administer concurrently with glucocorticosteroids, other non-steroidal anti-inflammatory drugs
or with anticoagulant agents.
Overdose
In case of overdose, symptomatic treatment should be initiated.
13. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE
MATERIALS, IF ANY
Any unused medicines or waste materials should not be disposed of via wastewater or household
waste but in accordance with local requirements. These measures should help to protect the
environment.
14. DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED
10.2010
Detailed information on this veterinary medicinal product is available on the website of the European
Medicines Agency
http://www.ema.europa.eu/
.
15. OTHER INFORMATION
Cardboard box with 1 colourless glass injection vial of 20 ml, 50 ml, 100 ml or 250 ml.
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.
35/35
Source: European Medicines Agency
- Please bookmark this page (add it to your favorites).
- If you wish to link to this page, you can do so by referring to the URL address below this line.
https://theodora.com/drugs/eu/novem_veterinary.html
Copyright © 1995-2021 ITA all rights reserved.