RevitaCAM
Kraj: Unia Europejska
Język: angielski
Źródło: EMA (European Medicines Agency)
Ulotka dla pacjenta
(PIL)
30-05-2016
Charakterystyka produktu
(SPC)
30-05-2016
Sprawozdanie z oceny publicznego
(PAR)
30-05-2016
Składnik aktywny:
meloxicam
Dostępny od:
Zoetis Belgium SA
Kod ATC:
QM01AC06
INN (International Nazwa):
meloxicam
Grupa terapeutyczna:
Dogs
Dziedzina terapeutyczna:
Oxicams
Wskazania:
Alleviation of inflammation and pain in both acute and chronic musculoskeletal disorders in dogs.
Podsumowanie produktu:
Revision: 5
Status autoryzacji:
Withdrawn
Data autoryzacji:
2012-02-23
Ulotka dla pacjenta
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
RevitaCAM 5 mg/ml oromucosal spray for Dogs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
ACTIVE SUBSTANCE: Meloxicam 5 mg
EXCIPIENTS: Ethyl alcohol 150 mg
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Oromucosal spray
Yellow colloidal dispersion
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 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 dogs less than 6 weeks of age.
This product is for dogs and should not be used in cats as it is not
suitable for use in this species.
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 the veterinarian should
be sought.
Avoid use in any dehydrated, hypovolaemic or hypotensive animal, as
there is a potential risk of
increased renal toxicity.
Medicinal product no longer authorised
3
Special precautions to be taken by the person administering the
veterinary medicinal product to
animals
Wash hands after administration of the product.
People with known hypersensitivity to Non Steriodal Anti-inflammatory
Drugs (NSAIDs) should
avoid contact with the veterinary medicinal product.
Avoid direct contact between the product and skin, if accidental
exposure occurs wash hands
immediately with soap and water.
4.6
ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS)
Typical adverse drug reactions of NSAI
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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
RevitaCAM 5 mg/ml oromucosal spray for Dogs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
ACTIVE SUBSTANCE: Meloxicam 5 mg
EXCIPIENTS: Ethyl alcohol 150 mg
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Oromucosal spray
Yellow colloidal dispersion
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 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 dogs less than 6 weeks of age.
This product is for dogs and should not be used in cats as it is not
suitable for use in this species.
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 the veterinarian should
be sought.
Avoid use in any dehydrated, hypovolaemic or hypotensive animal, as
there is a potential risk of
increased renal toxicity.
Medicinal product no longer authorised
3
Special precautions to be taken by the person administering the
veterinary medicinal product to
animals
Wash hands after administration of the product.
People with known hypersensitivity to Non Steriodal Anti-inflammatory
Drugs (NSAIDs) should
avoid contact with the veterinary medicinal product.
Avoid direct contact between the product and skin, if accidental
exposure occurs wash hands
immediately with soap and water.
4.6
ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS)
Typical adverse drug reactions of NSAI
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