Meloxidolor
Maa: Euroopan unioni
Kieli: englanti
Lähde: EMA (European Medicines Agency)
Pakkausseloste
(PIL)
28-01-2022
Valmisteyhteenveto
(SPC)
28-01-2022
Julkisesta arviointikertomuksesta
(PAR)
13-05-2013
Aktiivinen ainesosa:
meloxicam
Saatavilla:
Le Vet Beheer B.V
ATC-koodi:
QM01AC06
INN (Kansainvälinen yleisnimi):
meloxicam
Terapeuttinen ryhmä:
Horses; Dogs; Cattle; Cats; Pigs
Terapeuttinen alue:
Oxicams
Käyttöaiheet:
DogsAlleviation of inflammation and pain in both acute and chronic musculoskeletal disorders.Reduction of postoperative pain and inflammation following orthopaedic and soft-tissue surgery.CatsReduction of postoperative pain after ovariohysterectomy and minor soft-tissue surgery.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 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.
Tuoteyhteenveto:
Revision: 9
Valtuutuksen tilan:
Authorised
Valtuutus päivämäärä:
2013-04-22
Pakkausseloste
17
PARTICULARS TO APPEAR ON THE OUTER PACKAGE AND THE IMMEDIATE
PACKAGE
CARTON FOR THE 10 ML, 20 ML AND 100 ML
LABEL FOR 100 ML
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Meloxidolor 5 mg/ml solution for injection for dogs, cats, cattle and
pigs
meloxicam
2.
STATEMENT OF ACTIVE SUBSTANCES
Meloxicam 5 mg/ml
3.
PHARMACEUTICAL FORM
Solution for injection
4.
PACKAGE SIZE
10 ml
20 ml
100 ml
5.
TARGET SPECIES
Dogs, cats, cattle (calves) and pigs
6.
INDICATION(S)
7.
METHOD AND ROUTE(S) OF ADMINISTRATION
Dogs, Cattle: Single subcutaneous or intravenous injection
Cats: Single subcutaneous injection
Pigs: Single intramuscular injection
Read the package leaflet before use
8.
WITHDRAWAL PERIOD(S)
Withdrawal period:
CATTLE:
Meat and offal: 15 days
PIGS:
Meat and offal: 5 days
18
9.
SPECIAL WARNING(S), IF NECESSARY
Read the package leaflet before use.
10.
EXPIRY DATE
EXP (month/year)
Once broached, use by….
11.
SPECIAL STORAGE CONDITIONS
Read the package leaflet before use.
12.
SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS OR
WASTE MATERIALS, IF ANY
Disposal: read package leaflet.
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 THE SIGHT AND REACH OF CHILDREN”
Keep out of the sight and reach of children.
15.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
Le Vet Beheer B.V.
Wilgenweg 7
3421 TV Oudewater
The Netherlands
16.
MARKETING AUTHORISATION NUMBER(S)
EU/2/13/148/001
EU/2/13/148/002
EU/2/13/148/003
EU/2/13/148/008
EU/2/13/148/009
17.
MANUFACTURER’S BATCH NUMBER
Batch {number}
19
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
LABEL FOR 10 ML AND 20 ML
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Meloxidolor 5 mg/ml solution for injection for dogs, cats, cattle and
pigs
meloxicam
2.
QUANTITY OF THE ACTIVE SUBSTANCE(S)
Meloxicam 5 mg/ml
3.
CONTENTS BY WEIGHT, BY VOLUME OR BY NUMBER OF DOSES
10 ml
20 ml
4.
ROUTE(S)
Lue koko asiakirja
Valmisteyhteenveto
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Meloxidolor 5 mg/ml solution for injection for dogs, cats, 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
Dogs, cats, cattle (calves) and pigs
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
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.
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.
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 cases of hypersensitivity to the active substance or to
any of the excipients.
Do not use in dogs and cats suffering from gastrointestinal disorders
such as irritation and
haemorrhage, impaired hepatic, cardiac or renal function and
haemorrhagic disorders.
Do not use in dogs and cats less than 6 weeks of age nor in cats of
less than 2 kg.
3
Do not use in cattle and pigs suffering from impaired hepatic, cardiac
or renal function and
haemorrhagic disorders, or where there is evidence of ulcerogenic
gastrointestinal lesions.
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.
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