Emdocam
Country: European Union
Language: English
Source: EMA (European Medicines Agency)
Patient Information leaflet
(PIL)
16-06-2021
Summary of Product characteristics
(SPC)
16-06-2021
Public Assessment Report
(PAR)
18-11-2021
Active ingredient:
meloxicam
Available from:
Emdoka bvba
ATC code:
QM01AC06
INN (International Name):
meloxicam
Therapeutic group:
Horses; Pigs; Cattle
Therapeutic area:
Oxicams
Therapeutic indications:
CattleFor use in acute respiratory infection with appropriate antibiotic therapy to reduce clinical signs. For use in diarrhoea in combination with oral rehydration 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.PigsFor use in noninfectious locomotor disorders to reduce the symptoms of lameness and inflammation. For adjunctive therapy in the treatment of puerperal septicaemia and toxaemia (mastitits-metritis-agalactia syndrome) with appropriate antibiotic therapy.HorsesFor use in the alleviation of inflammation and relief of pain in both acute and chronic musculoskeletal disorders. For the relief of pain associated with equine colic.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.
Product summary:
Revision: 9
Authorization status:
Authorised
Authorization date:
2011-08-18
Patient Information leaflet
41
B. PACKAGE LEAFLET
42
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
43
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 treat
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Summary of Product characteristics
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Emdocam 20 mg/ml solution for injection for cattle, pigs and horses
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One ml contains:
ACTIVE SUBSTANCE:
Meloxicam
20 mg
EXCIPIENT:
Ethanol
150 mg
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection.
Clear yellow solution.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Cattle, pigs and horses.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
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.
4.3
CONTRAINDICATIONS
See also section 4.7.
Do not use in horses less than 6 weeks of age.
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.
3
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.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
Treatment of calves with Emdocam 20 minutes before dehorning reduces
post-operative pain. Emdocam
alone will not provide adequate pain relief dur
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