Loxicom

Country: European Union

Language: Slovenian

Source: EMA (European Medicines Agency)

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Patient Information leaflet Patient Information leaflet (PIL)
10-02-2022
Summary of Product characteristics Summary of Product characteristics (SPC)
10-02-2022
Public Assessment Report Public Assessment Report (PAR)
25-04-2019

Active ingredient:

meloksikam

Available from:

Norbrook Laboratories (Ireland) Limited

ATC code:

QM01AC06

INN (International Name):

meloxicam

Therapeutic group:

Dogs; Cats; Cattle; Pigs

Therapeutic area:

Anti-inflammatory and anti-rheumatic products, non-steroids

Therapeutic indications:

DogsAlleviation vnetja in bolečine v akutni in kronični mišično-skeletne motnje. Za zmanjšanje pooperativne bolečine in vnetja po ortopedski in operaciji mehkega tkiva. CatsAlleviation vnetja in bolečine v kronično mišično-skeletne motnje pri mačkah. Za zmanjšanje pooperativne bolečine po ovariohisterektomiji in manjših operacijah mehkega tkiva. CattleFor uporabo v akutne okužbe dihal in z ustreznimi antibiotiki terapije za zmanjšanje kliničnih znakov goveda. Za uporabo v driske v kombinaciji z oralno rehidracijo terapije za zmanjšanje kliničnih znakov, v teleta v enem tednu starosti in mladim, ki niso doječe goveda. Za dodatno zdravljenje pri zdravljenju akutnega mastitisa, v kombinaciji z antibiotično terapijo. PigsFor uporabo v noninfectious gibalne motnje za zmanjšanje simptomov lameness in vnetje. Za dodatno zdravljenje pri zdravljenju puerperalne septikemije in toksemije (sindroma mastitis-metritis-agalactia) z ustrezno antibiotično terapijo. HorsesFor uporabo v lajšanje vnetja in lajšanje bolečine v akutni in kronični mišično-skeletne motnje. Za lajšanje bolečin, povezanih z kopitarjem kopitarjev.

Product summary:

Revision: 17

Authorization status:

Pooblaščeni

Authorization date:

2009-02-10

Patient Information leaflet

                                81
B. NAVODILO ZA UPORABO
82
NAVODILO ZA UPORABO
Loxicom 0,5 mg/ml peroralna suspenzija za pse
1.
IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM TER
PROIZVAJALEC ZDRAVILA, ODGOVOREN ZA SPROŠČANJE SERIJ, ČE STA
RAZLIČNA
Imetnik dovoljenja za promet z zdravilom
Norbrook Laboratories (Ireland) Limited
Rossmore Industrial Estate
Monaghan
Ireland
Proizvajalec odgovoren za sproščanje serij:
Norbrook Manufacturing Limited
Rossmore Industrial Estate
Monaghan Town
Co. Monaghan
H18 W620
Ireland
Norbrook Laboratories Limited
105 Armagh Road
Newry
Co. Down, BT35 6PU
Združeno kraljestvo
2.
IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI
Loxicom 0,5 mg/ml, peroralna suspenzija za pse
meloksikam
3.
NAVEDBA UČINKOVIN(E) IN DRUGE(IH) SESTAVIN
Vsak ml vsebuje:
Meloksikam
0,5 mg
Natrijev benzoat
1,5 mg
4.
INDIKACIJE
Umirjanje vnetja in lajšanje bolečine pri akutnih in kroničnih
mišično-skeletnih obolenjih.
5.
KONTRAINDIKACIJE
Ne uporabite pri brejih in živalih v obdobju laktacije.
Ne uporabite pri psih z obolenji prebavil, kot so zdraženost prebavil
in krvavitev, oslabljeno
delovanje jeter, srca ali ledvic ter hemoragične motnje.
Ne uporabite v primerih preobčutljivosti na učinkovino ali na katero
koli pomožno snov.
Ne uporabite pri psih, mlajših od 6 tednov.
83
6.
NEŽELENI UČINKI
Občasno so poročali o značilnih neželenih učinkih nesteroidnih
protivnetnih zdravil, kot so izguba
teka, bruhanje, driska, kri v blatu (okultna krvavitev), apatija in
odpoved ledvic. Zelo redko (pri manj
kot 1 živali od 10.000 zdravljenih živali, vključno s posameznimi
primeri) so poročali o hemoragični
driski, hematemezi, razjedah prebavil in zvišani ravni jetrnih
encimov.
Našteti neželeni učinki so najpogostnejši prvi teden zdravljenja,
so večinoma prehodni in po
končanem zdravljenju minejo, vendar so lahko v zelo redkih primerih
tudi resni ali smrtno nevarni.
Če se pojavijo neželeni učinki, je zdravljenje treba prekiniti in
se posvetovati z veterinarjem.
Če opazite kakršne koli stranske učinke, tudi
                                
                                Read the complete document

Summary of Product characteristics

                                1
PRILOGA I
POVZETEK GLAVNIH ZNAČILNOSTI ZDRAVILA
2
1.
IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI
Loxicom 0,5 mg/ml peroralna suspenzija za pse
2.
KAKOVOSTNA IN KOLIČINSKA SESTAVA
Vsak ml vsebuje:
UČINKOVINA:
Meloksikam
0,5 mg
POMOŽNAE SNOVI:
Natrijev benzoat
1,5 mg
Za celoten seznam pomožnih snovi, glejte poglavje 6.1.
3.
FARMACEVTSKA OBLIKA
Peroralna suspenzija.
Bledo rumena suspenzija.
4.
KLINIČNI PODATKI
4.1
CILJNE ŽIVALSKE VRSTE
Psi.
4.2
INDIKACIJE ZA UPORABO PRI CILJNIH ŽIVALSKIH VRSTAH
Umirjanje vnetja in lajšanje bolečine pri akutnih in kroničnih
mišično-skeletnih obolenjih.
4.3
KONTRAINDIKACIJE
Ne uporabite pri brejih in živalih v obdobju laktacije.
Ne uporabite pri psih z obolenji prebavil, kot so zdraženost prebavil
in krvavitev, oslabljeno
delovanje jeter, srca ali ledvic ter hemoragične motnje.
Ne uporabite v primerih preobčutljivosti na učinkovino ali na katero
koli pomožno snov.
Ne uporabite pri psih, mlajših od 6 tednov.
4.4.
POSEBNA OPOZORILA ZA VSAKO CILJNO ŽIVALSKO VRSTO
Jih ni.
4.5
POSEBNI PREVIDNOSTNI UKREPI
Posebni previdnostni ukrepi za uporabo pri živalih
Če se pojavijo neželeni učinki, je treba zdravljenje prekiniti in
se posvetovati z veterinarjem.
Pri dehidriranih, hipovolemičnih ali hipotenzivnih živalih se
izogibamo dajanju zdravila zaradi možne
povečane toksičnosti za ledvice.
To zdravilo za pse se ne sme uporabljati pri mačkah zaradi različnih
odmernih brizg. Pri mačkah je treba
uporabiti Loxicom 0,5 mg/ml peroralno suspenzijo za mačke.
3
Posebni previdnostni ukrepi, ki jih mora izvajati oseba, ki živalim
daje zdravilo
Osebe z znano preobčutljivostjo na nesteroidna protivnetna zdravila
(NSAR) naj se izogibajo stiku z
zdravilom za uporabo v veterinarski medicini.
V primeru nenamernega zaužitja se takoj posvetujte z zdravnikom in mu
pokažite navodilo za
uporabo ali ovojnino.
4.6.
NEŽELENI UČINKI (POGOSTOST IN RESNOST)
Občasno so poročali o značilnih neželenih učinkih nesteroidnih
protivnetnih zdravil, kot so izguba
teka, bruhanje, dris
                                
                                Read the complete document

Similar products

Active ingredient meloksikam

meloksikam

ATC code QM01AC06

QM01AC06

Marketed by Norbrook Laboratories (Ireland) Limited

Norbrook Laboratories (Ireland) Limited

INN (International Name) meloxicam

meloxicam

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Loxicom