Novem
Maa: Euroopan unioni
Kieli: englanti
Lähde: EMA (European Medicines Agency)
Pakkausseloste
(PIL)
14-01-2022
Valmisteyhteenveto
(SPC)
14-01-2022
Julkisesta arviointikertomuksesta
(PAR)
02-06-2017
Aktiivinen ainesosa:
meloxicam
Saatavilla:
Boehringer Ingelheim Vetmedica GmbH
ATC-koodi:
QM01AC06
INN (Kansainvälinen yleisnimi):
meloxicam
Terapeuttinen ryhmä:
Pigs; Cattle
Terapeuttinen alue:
Anti-inflammatory and anti-rheumatic products, non-steroids
Käyttöaiheet:
Novem 5-mg/ml solution for injection for cattle and pigs: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 the relief of postoperative pain following dehorning in calves.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.Novem 20-mg/ml solution for injection for cattle and pigs: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.For the relief of postoperative pain following dehorning in calves.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 (mastitis-metritis-agalactia syndrome) with appropriate antibiotic therapy.Novem 40 mg/ml solution for injection for 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.
Tuoteyhteenveto:
Revision: 13
Valtuutuksen tilan:
Authorised
Valtuutus päivämäärä:
2004-03-02
Pakkausseloste
36
B. PACKAGE LEAFLET
37
PACKAGE LEAFLET:
Novem 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:
Boehringer Ingelheim Vetmedica GmbH
55216 Ingelheim/Rhein
GERMANY
Manufacturer responsible for batch release:
Labiana Life Sciences S.A.
Venus, 26
Can Parellada Industrial
08228 Terrassa
SPAIN
2.
NAME OF THE VETERINARY MEDICINAL PRODUCT
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
150 mg
Clear 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.
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.
38
6.
ADVERSE REACTIONS
In cattle, 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.
Anaphylactoid reactions which may be serious (including fatal), have
been observed very rarely from
post-marketing safety experience and
Lue koko asiakirja
Valmisteyhteenveto
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Novem 5 mg/ml solution for injection for cattle and pigs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One ml contains:
ACTIVE SUBSTANCE:
Meloxicam
5 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 (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.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
Treatment of calves with Novem 20 minutes before dehorning reduces
post-operative pain. Novem
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.
3
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
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