Inflacam
Country: Evrópusambandið
Tungumál: enska
Heimild: EMA (European Medicines Agency)
Upplýsingar fylgiseðill
(PIL)
19-03-2021
Vara einkenni
(SPC)
19-03-2021
Opinber matsskýrsla
(PAR)
12-12-2018
Virkt innihaldsefni:
meloxicam
Fáanlegur frá:
Chanelle Pharmaceuticals Manufacturing Ltd
ATC númer:
QM01AC06
INN (Alþjóðlegt nafn):
meloxicam
Meðferðarhópur:
Horses; Dogs; Cats; Cattle; Pigs
Lækningarsvæði:
Anti-inflammatory and anti-rheumatic products, non-steroids
Ábendingar:
Dogs: alleviation of inflammation and pain in both acute and chronic musculo-skeletal disorders.To reduce post-operative pain and inflammation following orthopaedic and soft tissue surgery.Cats: to reduce post-operative pain after ovariohysterectomy and minor soft tissue surgery.Alleviation of mild to moderate post-operative pain and inflammation following surgical procedures in cats, e.g. orthopaedic and soft tissue surgery.Alleviation of pain and inflammation in acute and chronic musculo-skeletal disorders in cats.Cattle: for use in acute respiratory infection with appropriate antibiotic therapy to reduce clinical signs.For use in diarrhoea in combination with oral re‑hydration 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.For the relief of post-operative pain following dehorning in calves.Pigs: for 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.For the relief of post operative pain associated with minor soft tissue such as castration.Horses: alleviation of inflammation and relief of pain in both acute and chronic musculo-skeletal disorders.For the relief of pain associated with equine colic.
Vörulýsing:
Revision: 12
Leyfisstaða:
Authorised
Leyfisdagur:
2011-12-09
Upplýsingar fylgiseðill
81
B. PACKAGE LEAFLET
82
PACKAGE LEAFLET:
INFLACAM 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 and manufacturer responsible for batch
release:
Chanelle Pharmaceuticals Manufacturing Ltd.,
Loughrea, Co. Galway, Ireland.
2.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Inflacam 1.5 mg/ml oral suspension for dogs
Meloxicam
3.
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
One ml contains: 1.5 mg of meloxicam,
5 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 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, lethargy and renal failure
have occasionally been reported. In
very rare cases haemorrhagic diarrhoea, haematemesis, gastrointestinal
ulceration and elevated liver
enzymes have 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.
If adverse reactions occur, treatment should be discontinued and the
advice of a veterinarian should be
sought.
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 animal
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Vara einkenni
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Inflacam 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
5 mg.
For the full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Oral suspension.
A yellow coloured 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
Avoid use in any dehydrated, hypovolaemic or hypotensive animal, as
there is a potential risk of renal
toxicity.
This product for dogs should not be used in cats as it is not suitable
for use in this species. In cats,
Inflacam 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,
lethargy and renal failure have occasionally been reported. In very
rare cases haemorrhagic diarrhoea,
haematemesis, gastrointestinal ulceration and elevated liv
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