Novaquin
Land: Den Europæiske Union
Sprog: engelsk
Kilde: EMA (European Medicines Agency)
Indlægsseddel
(PIL)
28-01-2022
Produktets egenskaber
(SPC)
28-01-2022
Offentlige vurderingsrapport
(PAR)
08-10-2015
Aktiv bestanddel:
meloxicam
Tilgængelig fra:
Le Vet Beheer B.V.
ATC-kode:
QM01AC06
INN (International Name):
meloxicam
Terapeutisk gruppe:
Horses
Terapeutisk område:
Oxicams
Terapeutiske indikationer:
Alleviation of inflammation and relief of pain in both acute and chronic musculo-skeletal disorders in horses.
Produkt oversigt:
Revision: 4
Autorisation status:
Authorised
Autorisation dato:
2015-09-08
Indlægsseddel
14
B. PACKAGE LEAFLET
15
PACKAGE LEAFLET:
NOVAQUIN 15 MG/ML ORAL SUSPENSION FOR HORSES
1.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF
THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH
RELEASE, IF DIFFERENT
Marketing authorisation holder:
Le Vet Beheer B.V.
Wilgenweg 7
3421 TV Oudewater
The Netherlands
Manufacturer responsible for batch release:
Produlab Pharma B.V.
Forellenweg 16
4941 SJ Raamsdonksveer
The Netherlands
2.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Novaquin 15 mg/ml oral suspension for horses
Meloxicam
3.
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
One ml contains:
ACTIVE SUBSTANCE
Meloxicam
15 mg.
EXCIPIENTS
Sodium benzoate
1.75
mg
Yellowish-green viscous oral suspension.
4.
INDICATION(S)
Alleviation of inflammation and relief of pain in both acute and
chronic musculo-skeletal disorders in
horses.
5.
CONTRAINDICATIONS
Do not use in pregnant or lactating mares.
Do not use in horses 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 horses less than 6 weeks of age.
6.
ADVERSE REACTIONS
16
Isolated cases of adverse reactions typically associated with
Non-Steroidal Anti-Inflammatory Drugs
(NSAIDs) were observed in clinical trials (slight urticaria,
diarrhoea). The clinical signs were
reversible.
Loss of appetite, lethargy, abdominal pain and colitis have been
reported in very rare cases.
Anaphylactoid reactions, which may be serious (including fatal), may
occur in very rare cases and
should be treated symptomatically.
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 animals in 1,000 animals
treated)
- rare (more than 1 but less than 10 an
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Produktets egenskaber
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Novaquin 15 mg/ml oral suspension for horses
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One ml contains:
ACTIVE SUBSTANCE:
Meloxicam
15
mg
EXCIPIENTS:
Sodium benzoate
1.75
mg
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Oral suspension.
Yellowish-green viscous oral suspension.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Horses.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Alleviation of inflammation and relief of pain in both acute and
chronic musculo-skeletal disorders in
horses.
4.3
CONTRAINDICATIONS
Do not use in pregnant or lactating mares.
Do not use in horses 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 horses 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, hypovolemic or hypotensive animals as
there is a potential risk of renal
toxicity.
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.
3
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)
Isolated cases of adverse reactions typically associated with NSAIDs
were observed in clinical trials
(slight urticaria, diarrhoea). The clinical signs were reversible.
Loss of appetite, lethargy, abdominal pain and colitis have been
reported in very rare cases.
Anaphylactoid reactions, which may be serious (including fatal), may
occur in very rare cases and
should be treated symptomatically.
I
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