Loxicom
Land: Den Europæiske Union
Sprog: engelsk
Kilde: EMA (European Medicines Agency)
Indlægsseddel
(PIL)
10-02-2022
Produktets egenskaber
(SPC)
10-02-2022
Offentlige vurderingsrapport
(PAR)
25-04-2019
Aktiv bestanddel:
meloxicam
Tilgængelig fra:
Norbrook Laboratories (Ireland) Limited
ATC-kode:
QM01AC06
INN (International Name):
meloxicam
Terapeutisk gruppe:
Dogs; Cats; Cattle; Pigs
Terapeutisk område:
Anti-inflammatory and anti-rheumatic products, non-steroids
Terapeutiske indikationer:
DogsAlleviation of inflammation and pain in both acute and chronic musculoskeletal disorders. To reduce postoperative pain and inflammation following orthopaedic and soft-tissue surgery.CatsAlleviation of inflammation and pain in chronic musculoskeletal disorders in cats. To reduce postoperative 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 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.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.
Produkt oversigt:
Revision: 17
Autorisation status:
Authorised
Autorisation dato:
2009-02-10
Indlægsseddel
80
B. PACKAGE LEAFLET
81
PACKAGE LEAFLET:
LOXICOM 0.5 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
Norbrook Laboratories (Ireland) Limited
Rossmore Industrial Estate
Monaghan
Ireland
Manufacturer responsible for batch release
Norbrook Manufacturing Limited
Rossmore Industrial Estate
Monaghan Town
Co. Monaghan
H18 W620
Ireland
Norbrook Laboratories Limited
105 Armagh Road
Newry
Co. Down, BT35 6PU
United Kingdom
2.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Loxicom 0.5
mg/ml oral suspension for dogs
meloxicam
3.
STATEMENT OF THE ACTIVE SUBSTANCE AND OTHER INGREDIENTS
Each ml contains:
Meloxicam
0.5
mg
Sodium benzoate
1.5 mg
4.
INDICATION(S)
Alleviation of inflammation and pain in both acute and chronic
musculo-skeletal disorders.
5.
CONTRAINDICATIONS
Do not use in pregnant or lactating animals.
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.
82
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 (less than 1 animal in 10,000 animals treated,
including isolated reports),
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.
If you notice any side e
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Produktets egenskaber
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Loxicom 0.5 mg/ml oral suspension for dogs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
ACTIVE SUBSTANCE:
Meloxicam
0.5 mg
EXCIPIENTS:
Sodium benzoate
1.5 mg
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Oral suspension.
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 in dogs.
4.3
CONTRAINDICATIONS
Do not use in pregnant or lactating animals.
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.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
4.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
If adverse reactions occur, treatment should be discontinued and the
advice of a veterinarian should be
sought.
Avoid use in any dehydrated, hypovolaemic or hypotensive animal, as
there is a potential risk of renal
toxicity.
3
This product for dogs should not be used in cats due to the different
dosing devices. In cats, Loxicom
0.5 mg/ml oral suspension for cats should be used.
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
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