Meloxidyl
Kraj: Unia Europejska
Język: angielski
Źródło: EMA (European Medicines Agency)
Ulotka dla pacjenta
(PIL)
07-02-2019
Charakterystyka produktu
(SPC)
07-02-2019
Sprawozdanie z oceny publicznego
(PAR)
06-09-2010
Składnik aktywny:
meloxicam
Dostępny od:
Ceva Santé Animale
Kod ATC:
QM01AC06
INN (International Nazwa):
meloxicam
Grupa terapeutyczna:
Dogs; Cats; Cattle; Pigs; Horses
Dziedzina terapeutyczna:
Oxicams
Wskazania:
DogsAlleviation of inflammation and pain in both acute and chronic musculoskeletal disorders.Reduction of post-operative pain and inflammation following orthopaedic and soft-tissue surgery.CatsReduction of post-operative pain after ovariohysterectomy and minor soft-tissue surgery.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 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.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: 14
Status autoryzacji:
Authorised
Data autoryzacji:
2007-01-15
Ulotka dla pacjenta
42
B. PACKAGE LEAFLET
43
PACKAGE LEAFLET:
MELOXIDYL 1.5 MG/ML ORAL SUSPENSION FOR DOGS
10, 32 & 100 ML
1.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF
THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH
RELEASE, IF DIFFERENT
Marketing authorisation holder:
Ceva Santé Animale
10 avenue de la Ballastière
33500 Libourne
France
Manufacturers responsible for batch release:
Ceva Santé Animale
Z.I. Très le Bois
22600 Loudéac
France
Vetem SpA
Lungomare Pirandello, 8
92014 Porto Empedocle (AG)
Italy
2.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Meloxidyl 1.5 mg/ml oral suspension for dogs.
Meloxicam
3.
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENTS
Each ml contains:
- 1.5 mg of meloxicam
- 2 mg of sodium benzoate
4.
INDICATION(S)
Alleviation of inflammation and pain in both acute and chronic
musculo-skeletal disorders in dogs.
5.
CONTRAINDICATIONS
Do not use in pregnant or lactating animals.
Do not use in animals suffering from gastrointestinal disorders such
as irritation and haemorrhage,
impaired hepatic, cardiac or renal function and haemorrhagic
disorders, or where there is evidence of
individual hypersensitivity to the product.
Do not use in dogs less than 6 weeks of age.
44
6.
ADVERSE REACTIONS
Typical adverse drug reactions of NSAIDs such as loss of appetite,
vomiting, diarrhoea, faecal occult
blood and apathy have occasionally been reported. These side effects
occur generally within the first
treatment week and are in most cases transient and disappear following
termination of the treatment
but in very rare cases may be serious or fatal.
The frequency of adverse reactions is defined using the following
convention:
- very common (more than 1 in 10 animals treated displaying adverse
reaction(s))
- common (more than 1 but less than 10 animals in 100 animals treated)
- uncommon (more than 1 but less than 10 animals in 1,000 animals
treated)
- rare (more than 1 but less than 10 animals in 10,000 animals
treated)
- very rare (less than 1 animal in 10,000 animals treated, includin
Przeczytaj cały dokument
Charakterystyka produktu
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Meloxidyl 1.5 mg/ml oral suspension for dogs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Composition for 1 ml
_ _
ACTIVE SUBSTANCE (S)_ _
Meloxicam
1.5 mg
EXCIPIENTS
Sodium benzoate
2 mg
For the full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Pale yellow suspension.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Dogs.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Alleviation of inflammation and pain in both acute and chronic
musculo-skeletal disorders.
4.3
CONTRAINDICATIONS
Do not use in pregnant or lactating animals.
Do not use in animals suffering from gastrointestinal disorders such
as irritation and haemorrhage,
impaired hepatic, cardiac or renal function and haemorrhagic
disorders, or where there is evidence of
individual hypersensitivity to the product.
Do not use in dogs less than 6 weeks of age.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
4.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
If side effects occur, treatment should be discontinued and the advice
of a veterinarian should be
sought.
Avoid use in any dehydrated, hypovolaemic or hypotensive animal, if
there is a potential risk of
increased renal toxicity.
3
Special precautions to be taken by the person administering the
veterinary medicinal product to
animals
People with known hypersensitivity to NSAIDs should avoid contact with
the veterinary medicinal
product.
In case of accidental ingestion, seek medical advice immediately and
show the package leaflet or the
label to the physician.
4.6
ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS)
Typical adverse drug reactions of NSAIDs such as loss of appetite,
vomiting, diarrhoea, faecal occult
blood and apathy have occasionally been reported. These side effects
occur generally within the first
treatment week and are in most cases transient and disappear following
termination of the treatment
but in very rare cases may be serious or fatal.
The frequency of adverse reacti
Przeczytaj cały dokument
