Melovem
Kraj: Unia Europejska
Język: angielski
Źródło: EMA (European Medicines Agency)
Ulotka dla pacjenta
(PIL)
19-06-2014
Charakterystyka produktu
(SPC)
19-06-2014
Sprawozdanie z oceny publicznego
(PAR)
10-10-2013
Składnik aktywny:
meloxicam
Dostępny od:
Dopharma Research B.V.
Kod ATC:
QM01AC06
INN (International Nazwa):
meloxicam
Grupa terapeutyczna:
Pigs; Calves
Dziedzina terapeutyczna:
Oxicams
Wskazania:
CattleFor use in acute respiratory infection with appropriate antibiotic therapy to reduce clinical signs in cattle. 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 the relief of postoperative pain associated with minor soft-tissue surgery such as castration. For adjunctive therapy in the treatment of puerperal septicaemia and toxaemia (mastitis-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.
Podsumowanie produktu:
Revision: 5
Status autoryzacji:
Authorised
Data autoryzacji:
2009-07-07
Ulotka dla pacjenta
35
B. PACKAGE LEAFLET
36
PACKAGE LEAFLET FOR:
Melovem 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:
Dopharma Research B.V.
Zalmweg 24
4941 VX Raamsdonksveer The Netherlands
Manufacturer responsible for batch release:
Dopharma B.V.
Zalmweg 24
4941 VX Raamsdonksveer The Netherlands
2.
NAME OF THE VETERINARY MEDICINAL PRODUCT
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.
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 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
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.
37
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.
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 intramuscu
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Charakterystyka produktu
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Melovem 5 mg/ml solution for injection for cattle and pigs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
ACTIVE SUBSTANCE:
Meloxicam 5 mg
EXCIPIENT(S):
Benzyl alcohol 50 mg
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection.
Clear, greenish yellow solution.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Cattle (calves and young cattle) and pigs.
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 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.
4.3
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.
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.
3
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
Treatment of calves with Melovem 20 minutes before dehorning reduces
post-operative pain.
Melovem 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.
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
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