ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
1
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Metacam 20 mg/ml solution for injection for cattle and pigs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of Metacam 20 mg/ml solution for injection contains:
Active substance(s):
Meloxicam
20 mg
Excipients:
Ethanol, anhydrous
3.
150 mg
PHARMACEUTICAL FORM
Solution for injection.
4.
PHARMACOLOGICAL PROPERTIES
4.1
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 B2 induced by E. coli endotoxin administration in calves, lactating
cows and pigs.
ATCvet code:
4.2
QM01AC06
Pharmacokinetic properties
Absorption
After a single subcutaneous dose of 0.5 mg meloxicam/kg, Cmaxvalues 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 Cmax 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.
2
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.
5.
CLINICAL PARTICULARS
5.1
Target species
Cattle and pigs
5.2
Indications for use
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-metritisagalactia syndrome) with appropriate antibiotic therapy.
5.3
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 or individual
hypersensitivity to the product.
For the treatment of diarrhoea in cattle, do not use in animals of less than one week of age.
5.4
Undesirable effects
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.
5.5
Special precaution(s) for use
Avoid use in very severely dehydrated, hypovolaemic or hypotensive animals which require parenteral
rehydration, as there may be a potential risk of increased renal toxicity.
5.6
Use during pregnancy and lactation
Cattle:
Can be used during pregnancy.
Pigs:
Can be used during pregnancy and lactation.
3
5.7
Interaction with other medicinal products and other forms of interaction
Do not administer concurrently with glucocorticosteroids, other non-steroidal anti-inflammatory drugs
or with anti-coagulant agents.
5.8
Posology and method of administration
Cattle:
Single subcutaneous or intravenous 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.
5.9
Overdose
In the case of overdosage symptomatic treatment should be initiated.
5.10 Special warnings for each target species
None.
5.11 Withdrawal period(s)
Cattle:
Meat and offal: 15 days
Milk: 5 days
Pigs:
Meat and offal: 5 days
5.12 Special precautions to be taken by the person administering the 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 insert or
the label to the physician.
6.
PHARMACEUTICAL PARTICULARS
6.1
Major incompatibilities
Not applicable.
6.2
Shelf life
Shelf-life of the veterinary medicinal product as packaged for sale: 3 years
4
Shelf-life after first opening the container: 28 days
6.3
Special precautions for storage
No special precautions for storage.
6.4
Nature and contents of container
Colourless glass injection vials of 50 and 100 ml, closed with a rubber stopper and sealed with an
aluminium cap.
6.5
Special precautions for the disposal of unused medicinal products or waste
if any
materials ,
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal
products should be disposed of in accordance with local requirements.
7.
NAME OR CORPORATE NAME AND ADDRESS OR REGISTERED PLACE OF
BUSINESS OF THE MARKETING AUTHORISATION HOLDER
Boehringer Ingelheim Vetmedica GmbH
55216 Ingelheim/Rhein
Germany
Prohibition of sale, supply and/or use
Not applicable.
Marketing Authorisation number(s)
EU/2/97/004/007-008
Date of first authorisation/renewal of the authorisation
Metacam 5 mg/ml solution for injection for cattle:
07.01.98
Metacam 20 mg/ml solution for injection for cattle:23.04.01
Date of revision of the text
12.05.2003
5
ANNEX III
LABELLING AND PACKAGE INSERT
6
A. LABELLING
7
PARTICULARS TO APPEAR ON THE OUTER PACKAGE
50 ml injection vials
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Metacam 20 mg/ml solution for injection for cattle and pigs
2.
STATEMENT OF ACTIVE AND OTHER SUBSTANCES
Meloxicam
3.
20 mg/ml
PHARMACEUTICAL FORM
Solution for injection
4.
PACKAGE SIZE
50 ml
5.
TARGET SPECIES
Cattle and pigs
6.
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-metritisagalactia syndrome) with appropriate antibiotic therapy.
7.
METHOD AND ROUTE(S) OF ADMINISTRATION
Cattle:
Single subcutaneous or intravenous injection.
Pigs:
Single intramuscular injection. If required, a second administration can be given after 24 hours.
Avoid introduction of contamination during use.
8
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 insert before use.
10.
EXPIRY DATE
EXP {month/year}
Shelf-life of broached vial: 28 days.
11.
SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE
MATERIALS , IF ANY
Dispose of in accordance with local requirements.
12.
THE WORDS "FOR ANIMAL TREATMENT ONLY"
For animal treatment only.
13.
THE WORDS "KEEP OUT OF REACH AND SIGHT OF CHILDREN"
Keep out of the reach and sight of children.
14.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF
THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH
RELEASE IN THE EEA, IF DIFFERENT
Marketing authorisation holder
Boehringer Ingelheim Vetmedica GmbH
55216 Ingelheim/Rhein
Germany
15.
Manufacturer
Labiana Life Sciences S.A.
08228 Terrassa
Spain
NUMBER(S) IN THE COMMUNITY REGISTER OF MEDICINAL PRODUCTS
EU/2/97/004/007
9
16.
MANUFACTURER´S BATCH NUMBER
Batch {number}
17.
CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
Veterinary medicinal product subject to prescription.
10
PARTICULARS TO APPEAR ON THE OUTER PACKAGE
100 ml injection vials
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Metacam 20 mg/ml solution for injection for cattle and pigs
2.
STATEMENT OF ACTIVE AND OTHER SUBSTANCES
Meloxicam
3.
20 mg/ml
PHARMACEUTICAL FORM
Solution for injection
4.
PACKAGE SIZE
100 ml
5.
TARGET SPECIES
Cattle and pigs
6.
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-metritisagalactia syndrome) with appropriate antibiotic therapy.
7.
METHOD AND ROUTE(S) OF ADMINISTRATION
Cattle:
Single subcutaneous or intravenous injection.
Pigs:
Single intramuscular injection. If required, a second administration can be given after 24 hours.
Avoid introduction of contamination during use.
11
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 insert before use.
10.
EXPIRY DATE
EXP {month/year}
Shelf-life of broached vial: 28 days.
11.
SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE
MATERIALS , IF ANY
Dispose of in accordance with local requirements.
12.
THE WORDS "FOR ANIMAL TREATMENT ONLY"
For animal treatment only.
13.
THE WORDS "KEEP OUT OF REACH AND SIGHT OF CHILDREN"
Keep out of the reach and sight of children.
14.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF
THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH
RELEASE IN THE EEA, IF DIFFERENT
Marketing authorisation holder
Boehringer Ingelheim Vetmedica GmbH
55216 Ingelheim/Rhein
Germany
15.
Manufacturer
Labiana Life Sciences S.A.
08228 Terrassa
Spain
NUMBER(S) IN THE COMMUNITY REGISTER OF MEDICINAL PRODUCTS
EU/2/97/004/008
12
16.
MANUFACTURER´S BATCH NUMBER
Batch {number}
17.
CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
Veterinary medicinal product subject to prescription.
13
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE
50 ml injection vials
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Metacam 20 mg/ml solution for injection for cattle and pigs
2.
STATEMENT OF ACTIVE AND OTHER SUBSTANCES
Meloxicam
3.
20 mg/ml
PACKAGE SIZE
50 ml
4.
TARGET SPECIES
Cattle and pigs
5.
METHOD AND ROUTE(S) OF ADMINISTRATION
Cattle: subcutaneous or intravenous injection.
Pigs: intramuscular injection.
Avoid introduction of contamination during use.
6.
WITHDRAWAL PERIOD
Cattle: meat and offal: 15 days; milk: 5 days
Pigs: meat and offal: 5 days
7. NAME OF THE MARKETING AUTHORISATION HOLDER
Boehringer Ingelheim Vetmedica GmbH
Germany
8.
MANUFACTURER´S BATCH NUMBER
Batch {number}
9.
EXPIRY DATE
EXP {month/year}
Shelf-life of broached vial: 28 days.
14
Once broached, use by...
10.
THE WORDS “FOR ANIMAL TREATMENT ONLY”
For animal treatment only.
15
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE
100 ml injection vials
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Metacam 20 mg/ml solution for injection for cattle and pigs
2.
STATEMENT OF ACTIVE AND OTHER SUBSTANCES
Meloxicam
3.
20 mg/ml
PACKAGE SIZE
100 ml
4.
TARGET SPECIES
Cattle and pigs
5.
METHOD AND ROUTE(S) OF ADMINISTRATION
Cattle: subcutaneous or intravenous injection.
Pigs: intramuscular injection.
Avoid introduction of contamination during use.
6.
WITHDRAWAL PERIOD
Cattle: meat and offal: 15 days; milk: 5 days
Pigs: meat and offal: 5 days
7. NAME OF THE MARKETING AUTHORISATION HOLDER
Boehringer Ingelheim Vetmedica GmbH
Germany
8.
MANUFACTURER´S BATCH NUMBER
Batch {number}
16
9.
EXPIRY DATE
EXP {month/year}
Shelf-life of broached vial: 28 days.
Once broached, use by...
10.
THE WORDS “FOR ANIMAL TREATMENT ONLY”
For animal treatment only.
17
B. PACKAGE INSERT
18
PACKAGE INSERT
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Metacam 20 mg/ml solution for injection for cattle and pigs
2.
STATEMENT OF THE ACTIVE AND OTHER SUBSTANCE(S)
Meloxicam 20 mg/ml
Ethanol
3.
150 mg/ml
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF
THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH
RELEASE IN THE EEA, IF DIFFERENT
Marketing authorisation holder
Boehringer Ingelheim Vetmedica GmbH
55216 Ingelheim/Rhein
Germany
4.
Manufacturer
Labiana Life Sciences S.A.
Venus, 26
Can Parellada Industrial
08228 Terrassa
Spain
TARGET SPECIES
Cattle and pigs
5.
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-metritisagalactia syndrome) with appropriate antibiotic therapy.
6.
DOSAGE FOR EACH SPECIES
Cattle:
Single subcutaneous or intravenous 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.
19
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.
7.
METHOD AND ROUTE(S) OF ADMINISTRATION
See 6.
8.
ADVICE ON CORRECT ADMINISTRATION
Avoid introduction of contamination during use.
9.
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 or individual
hypersensitivity to the product.
For the treatment of diarrhoea in cattle, do not use in animals of less than one week of age.
10.
UNDESIRABLE EFFECTS
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.
If you notice any other side effects, please inform your veterinary surgeon.
11.
WITHDRAWAL PERIOD
Cattle: meat and offal: 15 days; milk: 5 days
Pigs: meat and offal: 5 days
12.
SPECIAL STORAGE PRECAUTIONS
Keep out of the reach and sight of children.
Shelf-life of broached vial: 28 days.
Do not use after the expiry date stated on the carton and bottle.
13.
SPECIAL WARNING(S)
Avoid use in very severely dehydrated, hypovolaemic or hypotensive animals which require parenteral
rehydration, as there may be a potential risk of increased renal toxicity.
Do not administer concurrently with glucocorticosteroids, other non-steroidal anti-inflammatory drugs
or with anti-coagulant agents.
20
In the case of overdosage symptomatic treatment should be initiated.
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 this package insert or
the label to the physician.
14.
SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE
MATERIALS, IF ANY
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal
products should be disposed of in accordance with local requirements.
15.
DATE ON WHICH THE PACKAGE INSERT WAS LAST REVISED
05.2003
16.
OTHER INFORMATION
Veterinary medicinal product subject to prescription.
50 and 100 ml injection vials.
For any information about this veterinary medicinal product, please contact the local representative of
the marketing authorisation holder.
België/Belgique/Belgien
n.v. Boehringer Ingelheim s.a.
Diergeneeskundige Afdeling/
Division Vétérinaire
Arianelaan/16 Av. Ariane
B-1200 Brussel/Bruxelles
Tel/Tél: 02-773 33 11
Luxembourg/Luxemburg
n.v. Boehringer Ingelheim s.a.
Diergeneeskundige Afdeling/
Division Vétérinaire
Arianelaan/16 Av. Ariane
B-1200 Brussel/Bruxelles
Tel/Tél: +32-2-773 33 11
Danmark
Boehringer Ingelheim Danmark A/S
Strødamvej 52
DK-2100 København Ø
Tlf: 39 15 88 88
Nederland
Boehringer Ingelheim bv
Berenkoog 28
NL-1822 BJ Alkmaar
Tel: 072 566 24 11
Deutschland
Boehringer Ingelheim
Vetmedica GmbH
Binger Straße 173
D-55216 Ingelheim/Rhein
Tel: 01803 660 660
Norge
Boehringer Ingelheim Vetmedica A/S
Drengsrudbekken 25
Postboks 405
N-1373 Asker
Tlf: 66 76 13 20
Ελλάδα
Π.Ν. ΓΕΡΟΛΥΜΑΤΟΣ Α.Ε.Β.Ε.
Ασκληπιού 13,
GR-145 68 Κρυονέρι Αττικής
Τηλ: 210 8194 203
Österreich
Boehringer Ingelheim Austria GmbH
Dr. Boehringer Gasse 5-11
A-1121 Wien
Tel: 01-80 105 0
21
España
Boehringer Ingelheim España, S.A.
División Veterinaria
Prat de la Riba, s/n
Sector Turó de Can Matas
E-08190 Sant Cugat del Vallès (Barcelona)
Tel: 93 404 51 00
Portugal
Vetlima
Sociedade Distribuidora de Produtos
Agro-Pecuários S.A.
Av. 5 de Outubro, 35 - 3° Esq.
P-1050-047 Lisboa
Tel: 21 354 22 11
France
Boehringer Ingelheim France
Division Santé Animale
12, rue André Huet - B.P. 292
F-51060 Reims Cedex
Tél: 03 26 50 47 50
Suomi/Finland
Vetcare Oy
PL/PB 99
FIN-24101 Salo
Puh/Tel: 02 72 72 72
Ireland
Boehringer Ingelheim Limited
Ellesfield Avenue
Bracknell, Berkshire
UK-RG12 8YS
Tel: +44-1344 424 600
Sverige
Boehringer Ingelheim Vetmedica
Box 467
S-201 24 Malmö
Tel: 040 23 34 00
Ísland
PharmaNor hf.
Hörgatún 2
IS-210 Garðabær
Sími: 535 7000
United Kingdom
Boehringer Ingelheim Limited
Ellesfield Avenue
Bracknell, Berkshire
UK-RG12 8YS
Tel: 0134 4424 600
Italia
Boehringer Ingelheim Italia S.p.a.
Divisione Vetmedica
Località Prulli, 103/C
I-50066 Reggello (Firenze)
Tel: 055-8650-1
22