Melosus
Страна: Европейски съюз
Език: английски
Източник: EMA (European Medicines Agency)
Листовка
(PIL)
15-05-2019
Данни за продукта
(SPC)
15-05-2019
Доклад обществена оценка
(PAR)
15-05-2019
Активна съставка:
meloxicam
Предлага се от:
CP-Pharma Handelsgesellschaft mbH
АТС код:
QM01AC06
INN (Международно Name):
meloxicam
Терапевтична група:
Dogs; Cats; Guinea pigs
Терапевтична област:
Musculo-skeletal system
Терапевтични показания:
Dogs:Alleviation of inflammation and pain in both acute and chronic musculo-skeletal disorders in dogs.Cats: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 chronic musculo-skeletal disorders in cats.Guinea pigs:Alleviation of mild to moderate post-operative pain associated with soft tissue surgery such as male castration.
Каталог на резюме:
Revision: 7
Статус Оторизация:
Authorised
Дата Оторизация:
2011-02-21
Листовка
25
B. PACKAGE LEAFLET
26
PACKAGE LEAFLET:
MELOSUS 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:
CP-Pharma Handelsgesellschaft mbH
Ostlandring 13
D-31303 Burgdorf
Germany
Manufacturer responsible for batch release:
Produlab Pharma B.V.
Forellenweg 16
4941 SJ Raamsdonksveer
The Netherlands
2.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Melosus 1.5 mg/ml oral suspension for dogs
Meloxicam
3.
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENTS
ACTIVE SUBSTANCE:
Meloxicam
1.5 mg/ml
EXCIPIENTS:
Sodium benzoate
1.75 mg/ml
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 cases 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
27
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.
The frequency of adverse reactions is defined using the following
convention:
- very common (more than 1 in 10 animals treated displaying adverse
reactions)
- common (more than 1 but less th
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Данни за продукта
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Melosus 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 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 cases 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
increased renal toxicity.
3
This veterinary medicinal product for dogs should not be used in cats
as it is not suitable for use in
this species. In cats, Melosus 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
very rare cases haemorrhagic
diarrhoea, haematemesis, gastrointestinal
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