Flexicam
Kraj: Unia Europejska
Język: angielski
Źródło: EMA (European Medicines Agency)
Ulotka dla pacjenta
(PIL)
20-05-2014
Charakterystyka produktu
(SPC)
20-05-2014
Sprawozdanie z oceny publicznego
(PAR)
20-05-2014
Składnik aktywny:
meloxicam
Dostępny od:
Dechra Veterinary Products A/S
Kod ATC:
QM01AC06
INN (International Nazwa):
meloxicam
Grupa terapeutyczna:
Dogs; Cats
Dziedzina terapeutyczna:
Antiinflammatory and antirheumatic products
Wskazania:
Oral suspension:Dogs:Alleviation of inflammation and pain in both acute and chronic musculo-skeletal disorders.Solution for injection: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 postoperative pain after ovariohysterectomy and minor soft tissue surgery
Podsumowanie produktu:
Revision: 7
Status autoryzacji:
Withdrawn
Data autoryzacji:
2006-04-10
Ulotka dla pacjenta
Medicinal product no longer authorised
14
B. PACKAGE LEAFLET
Medicinal product no longer authorised
15
PACKAGE LEAFLET
Flexicam 5 mg/ml solution for injection for dogs and cats
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 Veterinary Products A/S
Mekuvej 9
DK-7171 Uldum
Denmark
MANUFACTURER FOR THE BATCH RELEASE
Accord Healthcare Limited
Sage House 1
st
Floor, 319 Pinner Road
North Harrow, Middlesex HA1 4HF
United Kingdom
2.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Flexicam 5 mg/ml solution for injection for dogs and cats
Meloxicam
3.
STATEMENT OF THE ACTIVE SUBSTANCE AND OTHER INGREDIENTS
1 ml of solution for injection contains 5 mg of meloxicam.
Other substances: Ethanol anhydrous 150 mg/ml.
4.
INDICATIONS
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.
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.
Do not use in case of hypersensitivity to the active substance or to
any of the excipients.
Do not use in animals less than 6 weeks of age nor in cats of less
than 2 kg.
Do not use an oral follow-up therapy using meloxicam or other NSAIDs
in cats, as no safe dosage for
repeated oral administration has been established.
Medicinal product no longer authorised
16
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. In dogs, these side
effects occur generally within
the first treatment week and are in most cases transient and disappear
follo
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Charakterystyka produktu
Medicinal product no longer authorised
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
Medicinal product no longer authorised
2
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Flexicam 5 mg/ml solution for injection for dogs and cats
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
ONE ML CONTAINS
Active substance:
Meloxicam 5 mg
Excipients:
Ethanol, anhydrous 150 mg
For a 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 and cats.
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.
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.
Do not use in case of hypersensitivity to the active substance or to
any of the excipients.
Do not use in animals less than 6 weeks of age nor in cats of less
than 2 kg.
Do not use an oral follow-up therapy using meloxicam or other NSAIDs
in cats, as no safe dosage for
repeated oral administration has been established.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
For post-operative pain relief in cats, safety has only been
documented after thiopental/halothane
anaesthesia.
Medicinal product no longer authorised
3
4.5
SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
If side effects occur, treatment should be discontinued.
Avoid use in any dehydrated, hypovolaemic or hypotensive animal, as
there is a potential risk of
increased renal toxicity.
SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE
VETERINARY MEDICINAL PRODUCT TO
ANIMALS
Accidental self-injection may give rise to pain.
People wi
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