Meloxoral
Country: Evrópusambandið
Tungumál: enska
Heimild: EMA (European Medicines Agency)
Upplýsingar fylgiseðill
(PIL)
04-10-2021
Vara einkenni
(SPC)
04-10-2021
Opinber matsskýrsla
(PAR)
29-11-2010
Virkt innihaldsefni:
meloxicam
Fáanlegur frá:
Dechra Regulatory B.V.
ATC númer:
QM01AC06
INN (Alþjóðlegt nafn):
meloxicam
Meðferðarhópur:
Dogs; Cats
Lækningarsvæði:
Musculo-skeletal system, Anti-inflammatory and anti-rheumatic products, non-steroids
Ábendingar:
CatsAlleviation of inflammation and pain in chronic musculoskeletal disorders.DogsAlleviation of inflammation and pain in both acute and chronic musculoskeletal disorders.
Vörulýsing:
Revision: 9
Leyfisstaða:
Authorised
Leyfisdagur:
2010-11-19
Upplýsingar fylgiseðill
24
B. PACKAGE LEAFLET
25 PACKAGE LEAFLET:
MELOXORAL 1.5 MG/ML ORAL SUSPENSION FOR DOGS
1.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF
THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH
RELEASE, IF DIFFERENT
Marketing authorisation holder:
Dechra Regulatory B.V.
Handelsweg 25
5531 AE Bladel
THE NETHERLANDS
Manufacturer for the batch release:
Produlab Pharma B.V.
Forellenweg 16
4941 SJ Raamsdonksveer
THE NETHERLANDS
2.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Meloxoral 1.5 mg/ml oral suspension for dogs
Meloxicam
3.
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENTS
One ml contains:
Meloxicam
1.5 mg.
Yellow/ green suspension.
4.
INDICATION(S)
Alleviation of inflammation and pain in both acute and chronic
musculo-skeletal disorders in dogs.
5.
CONTRAINDICATIONS
Do not use in dogs suffering from gastrointestinal disorders such as
irritation and haemorrhage,
impaired hepatic, cardiac or renal function and haemorrhagic
disorders.
Do not use in case of hypersensitivity to the active substance or to
any of the excipients.
Do not use in dogs less than 6 weeks of age.
6.
ADVERSE REACTIONS
Typical adverse reactions of non-steroidal anti-inflammatory drugs
(NSAIDs) such as loss of appetite,
vomiting, diarrhoea, faecal occult blood, apathy and renal failure
have occasionally been reported. In
very rare cases haemorrhagic diarrhoea, haematemesis, gastrointestinal
ulceration and elevated liver
enzymes have been reported. These adverse reactions 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.
If adverse reactions occur, treatment should be discontinued and the
advice of a veterinarian should be
sought.
26
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
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Vara einkenni
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Meloxoral 1.5 mg/ml oral suspension for dogs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One ml contains:
ACTIVE SUBSTANCE:
Meloxicam
1.5 mg.
EXCIPIENT:
Sodium benzoate
1.75 mg.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Oral suspension.
Yellow/ green 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 in dogs.
4.3
CONTRAINDICATIONS
Do not use in dogs suffering from gastrointestinal disorders such as
irritation and haemorrhage,
impaired hepatic, cardiac or renal function and haemorrhagic
disorders.
Do not use in case of hypersensitivity to the active substance or to
any of the excipients.
Do not use in dogs less than 6 weeks of age.
See section 4.7.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
4.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
Avoid use in any dehydrated, hypovolaemic or hypotensive animal, as
there is a potential risk of
increased renal toxicity.
This product for dogs should not be used in cats as it is not suitable
for use in this species. In cats,
Meloxoral 0.5 mg/ml oral suspension for cats should be used.
3
Special precautions to be taken by the person administering the
veterinary medicinal product to
animals
People with known hypersensitivity to non-steroidal anti-inflammatory
drugs (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 reactions of NSAIDs such as loss of appetite,
vomiting, diarrhoea, faecal occult blood,
apathy and renal failure have occasionally been reported. In very rare
cases haemorrhagic diarrhoea,
haematemesis, gastrointestinal ulceration and elevated liver enzymes
have
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