Acticam
Country: Unjoni Ewropea
Lingwa: Ingliż
Sors: EMA (European Medicines Agency)
Fuljett ta 'informazzjoni
(PIL)
24-03-2021
Karatteristiċi tal-prodott
(SPC)
24-03-2021
Rapport ta 'Valutazzjoni Pubblika
(PAR)
24-03-2021
Ingredjent attiv:
meloxicam
Disponibbli minn:
Ecuphar
Kodiċi ATC:
QM01AC06
INN (Isem Internazzjonali):
meloxicam
Grupp terapewtiku:
Dogs; Cats
Żona terapewtika:
Anti inflammatory and antirheumatic products
Indikazzjonijiet terapewtiċi:
Oral suspension:Dogs:Alleviation of inflammation and pain in both acute and chronic musculoskeletal disorders.Solution for injection:Dogs:Alleviation of inflammation and pain in both acute and chronic musculoskeletal disorders.Reduction of postoperative pain and inflammation following orthopaedic and soft-tissue surgery.Cats:Reduction of postoperative pain after ovariohysterectomy and minor soft-tissue surgery.
Sommarju tal-prodott:
Revision: 9
L-istatus ta 'awtorizzazzjoni:
Withdrawn
Data ta 'l-awtorizzazzjoni:
2008-12-09
Fuljett ta 'informazzjoni
Medicinal product no longer authorised
14
B. PACKAGE LEAFLET
Medicinal product no longer authorised
15
PACKAGE LEAFLET:
ACTICAM 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
Ecuphar NV
Legeweg 157-i
B-8020 Oostkamp
Belgium
2.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Acticam 5 mg/ml solution for injection for dogs and cats.
Meloxicam.
3.
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
Meloxicam 5 mg/ml.
Ethanol anhydrous 150 mg/ml.
4.
INDICATION(S)
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 cases 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.
6.
ADVERSE REACTIONS
Typical adverse reactions of NSAIDs such as loss of appetite,
vomiting, diarrhoea, faecal occult blood,
lethargy and renal failure have occasionally been reported. In very
rare cases elevated liver enzymes
have been reported. In dogs, in very rare cases, haemorrhagic
diarrhoea, haematemesis and
gastrointestinal ulceration have been reported. In dogs, 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. In very rare
cases anaphylactoid reactions may
occur and should be treated symptomatically.
Medicinal product no longer authorised
16
If adverse reactions occur
Aqra d-dokument sħiħ
Karatteristiċi tal-prodott
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
Acticam 5 mg/ml solution for injection for dogs and cats.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
ACTIVE SUBSTANCE:
Meloxicam 5 mg.
EXCIPIENTS:
Ethanol, anhydrous 150 mg.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection.
A 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 cases 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.
Aqra d-dokument sħiħ
