Onsior
Land: Den Europæiske Union
Sprog: engelsk
Kilde: EMA (European Medicines Agency)
Indlægsseddel
(PIL)
26-01-2021
Produktets egenskaber
(SPC)
26-01-2021
Offentlige vurderingsrapport
(PAR)
26-02-2020
Aktiv bestanddel:
robenacoxib
Tilgængelig fra:
Elanco GmbH
ATC-kode:
QM01AH91
INN (International Name):
robenacoxib
Terapeutisk gruppe:
Dogs; Cats
Terapeutisk område:
Anti-inflammatory and anti-rheumatic products, non-steroids, Coxibs
Terapeutiske indikationer:
Cats (tablets):For the treatmentRelief of pain and inflammation associated with acute andor chronic musculo-skeletal disorders.For the reduction of moderate pain and inflammation associated with orthopaedic surgery.Dogs (tablets):For the Ttreatment of pain and inflammation associated with chronic osteoarthritis.For the treatment of pain and inflammation associated with soft tissue surgery.Cats and dogs (solution for injection):For the Ttreatment of pain and inflammation associated with orthopaedic or soft tissue surgery.
Produkt oversigt:
Revision: 14
Autorisation status:
Authorised
Autorisation dato:
2008-12-16
Indlægsseddel
34
B. PACKAGE LEAFLET
35
PACKAGE LEAFLET:
ONSIOR 6 MG TABLETS FOR CATS
1.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF
THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH
RELEASE, IF DIFFERENT
Marketing authorisation holder:
Elanco GmbH
Heinz-Lohmann-Str. 4
27472 Cuxhaven
Germany
Manufacturer responsible for the batch release:
Elanco France S.A.S
26 Rue de la Chapelle
68330 Huningue
FRANCE
2.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Onsior 6 mg tablets for cats
Robenacoxib
3.
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
Each tablet contains 6 mg robenacoxib.
Tablets are round, beige to brown, non-divisible and with imprints
“NA” on one side and “AK” on the
other side.
Onsior tablets are easy to administer and well accepted by most cats.
4.
INDICATION(S)
For the treatment of pain and inflammation associated with acute and
chronic musculoskeletal disorders
in cats.
For the reduction of moderate pain and inflammation associated with
orthopaedic surgery in cats.
5.
CONTRAINDICATIONS
Do not use in cats suffering from ulceration in the digestive tract.
Do not use together with non-steroidal anti-inflammatory drugs
(NSAIDs) or corticosteroids, medicines
commonly used in the treatment of pain, inflammation and allergies.
Do not use in case of hypersensitivity to robenacoxib or to any of the
constituents of the tablets.
Do not use in pregnant or lactating cats or cats used for breeding
because the safety of this product has
not been established in these animals.
6.
ADVERSE REACTIONS
Mild and transient diarrhoea, soft faeces or vomiting were commonly
reported in clinical trials with
treatment up to 6 days. Lethargy may be observed in very rare cases.
In addition, elevated renal
parameters (creatinine, BUN and SDMA), and renal insufficiency have
been reported very rarely in post
marketing safety experience, more commonly in older cats and with
concomitant use of anaesthetic or
36
sedative agents (see also Sections: Special precautions for use,
Interaction with other medicina
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Produktets egenskaber
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Onsior 6 mg tablets for cats
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains:
ACTIVE SUBSTANCE:
Robenacoxib
6 mg.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet.
Round, beige to brown tablets with imprints “NA” on one side and
“AK” on the other side.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Cats.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the treatment of pain and inflammation associated with acute or
chronic musculoskeletal disorders
in cats.
For the reduction of moderate pain and inflammation associated with
orthopaedic surgery in cats.
4.3
CONTRAINDICATIONS
Do not use in cats suffering from gastrointestinal ulceration.
Do not use concomitantly with corticosteroids or other non-steroidal
anti-inflammatory drugs
(NSAIDs).
Do not use in case of hypersensitivity to the active substance or to
any of the excipients.
Do not use in pregnant and lactating animals (see section 4.7).
_ _
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
4.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
The safety of the veterinary medicinal product has not been
established in cats weighing less than 2.5 kg
or under 4 months of age.
Use in cats with impaired cardiac, renal or hepatic function or in
cats that are dehydrated, hypovolaemic
or hypotensive may involve additional risks. If use cannot be avoided,
these cats require careful
monitoring.
3
Response to treatment should be monitored at regular intervals by a
veterinary surgeon. Clinical field
studies showed that robenacoxib was well-tolerated by most cats for up
to 12 weeks.
Use this veterinary medicinal product under strict veterinary
monitoring in cats with a risk of
gastrointestinal ulcers, or if the cat previously displayed
intolerance to other NSAIDs.
Special precautions to be taken by the person administering the
veterinary medicinal product to animals
Wash hands after use of the veterinary m
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