natgillin/translations-raw huggingface dataset:
Marketing authorisation holder and manufacturer responsible for batch release: Chanelle Pharmaceuticals Manufacturing Ltd., Loughrea,
Imetnik dovoljenja za promet z zdravilom in izdelovalec odgovoren za sproščanje serij: Chanelle Pharmaceuticals Manufacturing Ltd., Loughrea,
Cattle: SC or IV injection.
POT(I) UPORABE ZDRAVILA Govedo: s.c. ali i.v.
Meloxicam: 5 mg/ml, Ethanol (96%): 159.8 mg/ml.
Meloksikam 5 mg Pomožna snov Etanol (96%) 159.8 mg
In the case of overdose, symptomatic treatment should be initiated.
V primeru prevelikega odmerka je potrebnu uvesti simptomatsko zdravljenje.
Inflacam 5 mg/ml solution for injection for dogs and cats
Inflacam 5 mg/ml raztopina za injiciranje za pse in mačke
Typical adverse drug reactions of non-steroidal anti-inflammatory drugs such as loss of appetite, vomiting, diarrhoea, faecal occult blood, lethargy and renal failure have occasionally been reported.
Občasno so poročali o značilnih neželenih učinkih nesteroidnih protivnetnih zdravil, kot so izguba teka, bruhanje, driska, kri v blatu (okultna krvavitev), letargija in ledvična odpoved.
Shelf life of the veterinary medicinal product as packaged for sale: 3 years.
Rok uporabnosti zdravila v pakiranju za prodajo: 3 leti.
Glycine
OVOJNINAH
In cats, Inflacam 0.5 mg/ml oral suspension for cats should be used.
Pri mačkah uporabljamo zdravilo Inflacam 0,5 mg/ml peroralna suspenzija za mačke.
Read the package leaflet before use.
Pred uporabo preberite navodilo v ovitku.
PACKAGE LEAFLET: Inflacam 330 mg granules for horses
IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI Inflacam 330 mg zrnca za konje
Meloxicam is predominantly found in plasma and is also a major biliary excretion product whereas urine contains only traces of the parent compound.
Meloksikam se pretežno nahaja v plazmi in je tudi pomemben produkt pri biliarnem izločanju, medtem ko so v urinu samo sledi matične spojine.
More than 98 % of meloxicam is bound to plasma proteins.
Več kot 98 % meloksikama se veže na beljakovine v plazmi.
Marketing authorisation holder and manufacturer responsible for batch release: Chanelle Pharmaceuticals Manufacturing Ltd., Loughrea, Co. Galway, Ireland.
Imetnik dovoljenja za promet z zdravilom in izdelovalec odgovoren za sproščanje serij Chanelle Pharmaceuticals Manufacturing Ltd., Loughrea, Co. Galway, Irska.
Cattle: meat and offal: 15 days; milk: 5 days.
Govedo: meso in organi: 15 dni; mleko: 5 dni Prašiči: meso in organi: 5 dni
Meloxicam also has anti-endotoxic properties because it has been shown to inhibit production of thromboxane B2 induced by E. coli endotoxin administration in calves, lactating cows and pigs.
Deluje tudi antiendotoksično, saj so dokazali, da zavira nastajanje tromboksana B2, izzvano z vnosom endotoksina E. coli pri teletih, kravah v obdobju laktacije in prašičih.
Gastrointestinal ulceration and elevated liver enzymes were reported in very rare cases.
V zelo redkih primerih so poročali o gastrointestinalnih razjedah in zvišani ravni jetrnih encimov.
Meat and offal: 15 days.
Meso in organi: 15 dni
Excipient Sodium benzoate 1.5 mg
Natrijev benzoat 1,5 mg
Shelf life after first opening the immediate packaging: 6 months.
Rok uporabnosti po prvem odpiranju stične ovojnine: 6 mesecev
159.8 mg.
159.8 mg Prozorna rumena raztopina.
Typical adverse reactions of non-steroidal anti-inflammatory drugs (NSAIDs) such as loss of appetite, vomiting, diarrhoea, faecal occult blood, lethargy and renal failure have occasionally been reported.
Občasno so poročali o značilnih neželenih učinkih nesteroidnih protivnetnih zdravil, kot so izguba teka, bruhanje, driska, kri v blatu (okultna krvavitev), zaspanost in ledvična odpoved.
Shelf life of the veterinary medicinal product as packaged for sale: 2 years.
Rok uporabnosti zdravila v pakiranju za prodajo: 2 leti
Meloxicam also has anti-endotoxic properties because it has been shown to inhibit production of thromboxane B2 induced by E. coli endotoxin administration in calves and pigs.
Deluje tudi antiendotoksično, saj so dokazali, da zavira nastajanje tromboksana B2, izzvano z vnosom endotoksina E. coli pri teletih in prašičih.
Shelf life after first opening of the immediate packaging: 3 months.
Rok uporabnosti po prvem odpiranju stične ovojnine: 3 mesecev.
More than 97 % of meloxicam is bound to plasma proteins.
Več kot 97 % meloksikama se veže na beljakovine v plazmi.
In case of overdose symptomatic treatment should be initiated.
V primeru prevelikega odmerjanja je treba uvesti simptomatsko zdravljenje.
Initial treatment is a single oral dose of 0.1 mg meloxicam/kg body weight (0.2 ml/kg) on the first day.
Začetni odmerek prvi dan zdravljenja je 0,1 mg meloksikama na kilogram telesne mase (0,2 ml /kg)
Use during pregnancy and lactation: Do not use in pregnant or lactating animals.
Uporaba v obdobju brejosti in laktacije Ne uporabite v obdobju brejosti in laktacije.
PACKAGE LEAFLET: Inflacam 1.5 mg/ml oral suspension for dogs
NAVODILO ZA UPORABO Inflacam 1,5 mg/ml, peroralna suspenzija za pse
Label for 20 ml bottles
OVOJNINAH Nalepka za 20 ml vialo
Body weight (kg)
Shema odmerjanja za vzdrževalni odmerka: Telesna masa (kg)
Equidae
Smukec
Approximately 97 % of meloxicam is bound to plasma proteins.
Približno 97 % meloksikama se veže na beljakovine v plazmi.
Concurrent administration of potential nephrotoxic drugs should be avoided.
Sočasnemu dajanju zdravil, ki lahko imajo nefrotoksične učinke, se je treba izogibati.
In very rare cases haemorrhagic diarrhoea, haematemesis, gastrointestinal ulceration and elevated liver enzymes have been reported.
V zelo redkih primerih se pojavijo hemoragična driska, bruhanje krvi (hematemeza), prebavne razjede in povišane vrednosti jetrnih encimov.
Meat and offal: 5 days.
Meso in organi: 5 dni
Lactose monohydrate Silicified microcrystalline cellulose Sodium acid citrate Crospovidone
Celuloza mikrokristalna, silicificirana
Approximately 98% of meloxicam is bound to plasma proteins.
Približno 98 % meloksikama se veže na beljakovine v plazmi.
Chanelle Pharmaceuticals Manufacturing Ltd.
IME IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM Chanelle Pharmaceuticals Manufacturing Ltd.
Active substance Meloxicam 0.5 mg.
Meloksikam 0,5 mg Pomožna snov:
Alleviation of inflammation and relief of pain in both acute and chronic musculo-skeletal disorders in horses.
Umirjanje vnetja in lajšanje bolečine pri akutnih in kroničnih mišično-skeletnih obolenjih pri konjih.
Shelf life of the veterinary medicinal product as packaged for sale: 4 years.
Rok uporabnosti zdravila v pakiranju za prodajo: 4 leta
Sodium carboxyl methyl cellulose Colloidal silicon dioxide Citric acid monohydrate Sorbitol solution
Seznam pomožnih snovi natrijev saharinat natrijev karmelozat silicijev dioksid, koloidni, brezvodni citronska kislina monohidrat sorbitol, tekoči (nekristalizirajoči)
Detailed information on this product is available on the website of the European Medicines Agency (http://www.ema.europa.eu).
Podrobne informacije o tem zdravilu so na voljo na spletni strani Evropske agencije za zdravila (European Medicines Agency) (http://www.ema.europa.eu/).
One ml contains: 15 mg of meloxicam, 5 mg of sodium benzoate.
En ml vsebuje: 15 mg meloksikama 5 mg natrijevega benzoata
Interaction with other medicinal products and other forms of interaction: Do not administer concurrently with glucocorticosteroids, other non-steroidal anti-inflammatory drugs or with anticoagulant agents.
Medsebojno delovanje z drugimi zdravili in druge oblike interakcij Ne uporabljajte hkrati z glukokortikosteroidi, drugimi nesteroidnimi protivnetnimi zdravili ali antikoagulanti.
Saccharin sodium
Natrijev citrat
One ml contains: 1.5 mg of meloxicam, 5 mg of sodium benzoate.
En ml vsebuje: 1,5 mg meloksikama 5 mg natrijevega benzoata
Inflacam must not be administered in conjunction with other NSAIDs or glucocorticosteroids.
Inflacama ne smemo dajati hkrati z drugimi nesteroidnimi protivnetnimi zdravili ali glukokortikosteroidi.
Use during pregnancy and lactation:
Uporaba v obdobju brejosti in laktacije
Initial treatment is a single dose of 0.2 mg meloxicam/kg body weight on the first day.
Začetni odmerek prvi dan zdravljenja je 0,2 mg meloksikama na kilogram telesne mase.
For use in the alleviation of inflammation and relief of pain in both acute and chronic musculo-skeletal disorders.
Za umirjanje vnetja in lajšanje bolečine pri akutnih in kroničnih mišično-skeletnih obolenjih.
The suspension can be given using the Inflacam measuring syringe provided in the package.
Zdravilo dajemo peroralno, pomešano med hrano ali v gobec Suspenzijo lahko dajemo s priloženo merilno brizgo za Inflacam.
Treatment is to be continued once daily by oral administration (at 24-hour intervals) at a maintenance dose of 0.05 mg meloxicam/kg body weight (0.1 ml /kg).
Zdravljenje nadaljujemo z enim peroralnim, vzdrževalnim odmerkom po 0,05 mg meloksikama na kilogram telesne mase (0,1 ml /kg) na dan (v 24-urnih presledkih).
Label for 20 ml and 50 ml bottles
OVOJNINAH Nalepka za 20 ml, 50 ml vialo
Each sachet contains one dose for a horse weighing 500 kg - 600 kg.
Vsaka vrečica vsebuje en odmerek za konja, ki tehta med 500 - 600 kg. Odmerka se ne sme razdeliti.
Inflacam 330 mg, granules for horses.
IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI Inflacam 330 mg, zrnca za konje.
Carton
ère
EU/2/11/134/023 10 ml EU/2/11/134/024 15 ml
EU/2/11/134/024 15 ml
Alleviation of inflammation and pain in both acute and chronic musculo-skeletal disorders in dogs.
Umirjanje vnetja in lajšanje bolečine pri akutnih in kroničnih mišično-skeletnih obolenjih psov.
People with known hypersensitivity to non-steroidal anti-inflammatory drugs (NSAIDs) should avoid contact with the veterinary medicinal product.
Osebe z znano preobčutljivostjo za nesteroidna protivnetna zdravila (NSAID) naj se izogibajo stiku z zdravilom.
In cats, meloxicam is predominantly found in plasma and is also a major biliary excretion product whereas urine contains only traces of the parent compound.
Meloksikam se pri mačkah pretežno nahaja v plazmi in je tudi pomembna sestavina pri izločanju zdravila z žolčem, medtem ko vsebuje urin samo sledi matične spojine.
People with known hypersensitivity to non-steroidal anti-Inflammatory drugs (NSAIDs) should avoid contact with the veterinary medicinal product.
Osebe z znano preobčutljivostjo na nesteroidna protivnetna zdravila (NSAID) naj se izogibajo stiku z zdravilom.
Overdose (symptoms, emergency procedures, antidotes): In the case of overdose symptomatic treatment should be initiated.
Preveliko odmerjanje (simptomi, nujni ukrepi, protistrupi) Pri vnosu prevelikega odmerka uvedemo simptomatsko zdravljenje.
Alleviation of inflammation and pain in both acute and chronic musculo-skeletal disorders.
Umirjanje vnetja in lajšanje bolečine pri akutnih in kroničnih mišično-skeletnih obolenjih.
Excipient Sodium benzoate 5 mg.
Meloksikam 15 mg Pomožna snov Natrijev benzoat 5 mg
Each ml contains: 1.5 mg of meloxicam, 5 mg of sodium benzoate.
1 ml vsebuje: 1,5 mg meloksikama 5 mg natrijevega benzoata
Do not use in horses suffering from gastrointestinal disorders such as irritation and haemorrhage, impaired hepatic, cardiac or renal function and haemorrhagic disorders.
Ne uporabite pri konjih z obolenji prebavil, kot so razdraženost prebavil in krvavitve, pri motnjah delovanja jeter, srca ali ledvic in pri hemoragičnih obolenjih.
In dogs, meloxicam is predominantly found in plasma and is also a major biliary excretion product whereas urine contains only traces of the parent compound.
Meloksikam se pri psih pretežno nahaja v plazmi in je tudi pomembna sestavina pri izločanju zdravila z žolčem, medtem ko vsebuje urin samo sledi matične spojine.
EU/2/11/134/003 100 ml EU/2/11/134/004 200 ml
EU/2/11/134/004 200 ml
Single subcutaneous or intravenous injection at a dosage of 0.5 mg meloxicam/kg body weight (i.e. 2.5 ml/100 kg body weight) in combination with antibiotic therapy or with oral re-hydration therapy, as appropriate.
(to je 2,5 ml/100 kg telesne mase), po potrebi v kombinaciji z antibiotičnim zdravljenjem ali s peroralno rehidracijsko terapijo.
Pharmacotherapeutic group: Anti-inflammatory and anti-rheumatic products, non-steroids (oxicams).
Farmakoterapevtska skupina: nesteroidna protivnetna in protirevmatična zdravila (oksikami).
Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu.
Podrobne informacije o tem zdravilu za uporabo v veterinarski medicini so na voljo na spletni strani Evropske agencije za zdravila (http://www.ema.europa.eu0.
PACKAGE LEAFLET: Inflacam 15 mg/ml oral suspension for horses
IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI Inflacam 15 mg/ml peroralna suspenzija za konje
Inflacam 15 mg/ml oral suspension for horses Meloxicam
IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI Inflacam 15 mg/ml peroralna suspenzija za konje Meloksikam
In very rare cases anaphylactoid reactions which may be serious (including fatal) may occur and should be treated symptomatically.
V zelo redkih primerih se lahko pojavijo anafilaktične reakcije, ki so lahko resne (tudi smrtne) in jih je treba zdraviti simptomatsko.
Manufacturers responsible for the batch release: Chanelle Pharmaceuticals Manufacturing Ltd., Loughrea, Co. Galway,
Izdelovalec, odgovoren za sproščanje serij Chanelle Pharmaceuticals Manufacturing Ltd. Loughrea, Co. Galway, IRSKA.
Cardboard box with 1 colourless glass injection vial containing 20 ml, 50 ml, 100 ml or 250 ml.
Kartonska škatla z 1 brezbarvno stekleno injekcijsko vialo po 20 ml, 50 ml, 100 ml ali 250 ml. Ni nujno, da so v prometu vsa navedena pakiranja.
Do not use in dogs suffering from gastrointestinal disorders such as irritation and haemorrhage, impaired hepatic, cardiac or renal function and haemorrhagic disorders.
Ne uporabite pri psih z obolenji prebavil, kot so razdraženost prebavil in krvavitve, pri motnjah delovanja jeter, srca ali ledvic in pri hemoragičnih obolenjih.
Do not use in cats suffering from gastrointestinal disorders such as irritation and haemorrhage, impaired hepatic, cardiac or renal function and haemorrhagic disorders.
Ne uporabite pri mačkah z obolenji prebavil, kot so vzdraženost prebavil in krvavitve, pri motnjah delovanja jeter, srca ali ledvic in pri hemoragičnih obolenjih.
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENTS
NAVEDBA ZDRAVILNE UČINKOVINE IN DRUGIH SESTAVIN
Water for injections
FARMACEVTSKA OBLIKA Raztopina za injiciranje
EXP {month/year} Once broached, use by…
Načeto/odprto zdravilo uporabite do…
ROUTE(S) OF ADMINISTRATION
NAČIN IN POT(I)UPORABE
Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency (http://www.ema.europa.eu).
Podrobne informacije o tem zdravilu za uporabo v veterinarski medicini so na voljo na spletni strani Evropske agencije za zdravila (http://www.ema.europa.eu).
Oral suspension.
FARMACEVTSKA OBLIKA Peroralna suspenzija.
Carton for 10 ml, 20 ml and 100 ml vial
PODATKI NA ZUNANJI OVOJNINI {Škatla za 10 ml, 20 ml ali 100 ml vialo}
PACKAGE LEAFLET: Inflacam 5 mg/ml solution for injection for dogs and cats
IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI Inflacam 5 mg/ml raztopina za injiciranje za pse in mačke
Manufacturers responsible for batch release:
Izdelovalec, odgovoren za sproščanje serij
Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu
Podrobne informacije o tem zdravilu za uporabo v veterinarski medicini so na voljo na spletni strani Evropske agencije za zdravila (http://www.ema.europa.eu)
Single subcutaneous or intravenous injection at a dosage of 0.5 mg meloxicam/kg body weight (i.e. 10 ml/100 kg body weight) in combination with antibiotic therapy or with oral re-hydration therapy, as appropriate.
(to je 10 ml/100 kg telesne mase), po potrebi v kombinaciji z antibiotičnim zdravljenjem ali s peroralno rehidracijsko terapijo.
Inflacam 330 mg granules for horses.
IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI Inflacam 330 mg zrnca za konje.
Cardboard box containing 1 colourless glass injection vial of 20 ml, 50 ml or 100 ml.
Kartonska škatla z 1 brezbarvno stekleno injekcijsko vialo po 20 ml, 50 ml ali 100 ml. Ni nujno, da so v prometu vsa navedena pakiranja.
Carton for 20 ml, 50 ml, 100 ml and 250 ml
PODATKI NA ZUNANJI OVOJNINI Škatla za 20 ml, 50 ml, 100 ml ali 250 ml vialo
Shelf-life of the veterinary medicinal product as packaged for sale: 30 months Shelf life after first opening the immediate packaging: 3 months.
Rok uporabnosti zdravila v pakiranju za prodajo: 30 mesecev.
Avoid use in any dehydrated, hypovolaemic or hypotensive animal, as there is a potential risk of renal toxicity.
Zaradi nevarnosti toksičnih učinkov na ledvice se dajanju zdravila izogibamo pri dehidriranih, hipovolemičnih ali hipotenzivnih živalih.
Single intramuscular injection at a dosage of 0.4 mg meloxicam/kg body weight (i.e. 2.0 ml/25 kg body weight).
Enkratna intramuskularna injekcija odmerka po 0,4 mg meloksikama na kilogram telesne mase (to je 2,0
Cattle: meat and offal: 15 days.
Govedo: meso in organi: 15 dni Prašiči: meso in organi: 5 dni
Inflacam 1.5 mg/ml oral suspension for dogs Meloxicam
IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI Inflacam 1,5 mg/ml peroralna suspenzija za pse Meloksikam
Treatment is to be continued once daily by oral administration (at 24-hour intervals) at a maintenance dose of 0.1 mg meloxicam/kg body weight.
Zdravljenje nadaljujemo z enim peroralnim,-vzdrževalnim odmerkom po 0,1 mg meloksikama na kilogram telesne mase na dan (v 24-urnih presledkih).
Dose scheme for the maintenance dose:
DAJANJA ZDRAVILA Odmerjanje
In very rare cases anaphylactoid reactions, which may be serious (including fatal), may occur and should be treated symptomatically.
Zelo redko se lahko pojavijo anafilaktoidne reakcije, ki so lahko resne (vključno s smrtnimi) in jih je treba zdraviti simptomatsko.
INDICATIONS
ZDRAVILA
In this situation, you should inform your doctor as soon as possible.
V tem primeru čim prej obvestite zdravnika.
Recommended wording
Priporočeno besedilo
Avoid any unnecessary exercise as this might increase the risk of a tendon rupture.
Izogibajte se kakršni koli nepotrebni vadbi, saj lahko poveča tveganje za pretrganje kite.
Before taking this medicine
Preden boste vzeli to zdravilo
Therefore the following text should be added in Section 4.1 as relevant:
Zato je treba v poglavju 4.1 dodati naslednje besedilo, kot je primerno:
Therefore, concomitant use of corticosteroids should be avoided.
Sočasni uporabi kortikosteroidov se je zato treba izogibati.
Section 4.8: undesirable effects
Poglavje 4.8: Neželeni učinki
Medically incorrect indications
Medicinsko nepravilne indikacije
Should medicinal products no longer have any authorised indications with a positive benefit-risk balance then the national competent authorities should take the appropriate action in line with the conclusions on this procedure under Article 31 of Directive 2001/83/EC.
Če zdravila nimajo več dovoljenih indikacij s pozitivnim razmerjem med koristmi in tveganji, morajo nacionalni pristojni organi sprejeti ustrezne ukrepe v skladu z zaključki tega postopka, ki je v skladu z 31. členom Direktive 2001/83/ES.
You and your doctor will decide on continuing the treatment considering also an antibiotic from another class.
Skupaj z zdravnikom se boste odločili o nadaljnjem zdravljenju, morebiti tudi z antibiotikom iz kakšne druge skupine.
The product information may be subsequently updated by the Member State competent authorities, in liaison with the reference Member State, as appropriate, in accordance with the procedures laid down in Chapter 4 of Title III of Directive 2001/83/EC.
Informacije o zdravilu bodo morda pristojni organi držav članic v sodelovanju z referenčno državo članico kasneje posodobili, če je primerno, v skladu s postopki opredeljenimi v poglavju 4 naslova III Direktive 2001/83/ES.
Recommended wording of category 1 indications
Priporočeno besedilo za indikacije kategorije 1
When taking this medicine
Med jemanjem tega zdravila
The following new warning should be included at the beginning of the warning statements on safety issues:
Naslednje novo opozorilo je treba vključiti na začetku opozorilnih stavkov o pomislekih glede varnosti:
Section 4.1: therapeutic indications
Poglavje 4.1: Terapevtske indikacije
If this happens, stop taking <product name> and inform your doctor immediately in order to prevent the development of potentially irreversible condition.
Če se to zgodi, prenehajte jemati zdravilo <ime zdravila> in o tem takoj obvestite zdravnika, da preprečite razvoj potencialno ireverzibilnega stanja.
Consideration should be given to official guidance on the appropriate use of antibacterial agents.
Pri zdravljenju je treba upoštevati uradne smernice o pravilni uporabi protibakterijskih zdravil.
For systemically administered levofloxacin containing products the listing of risk factors within the first above mentioned sentence should additionally include “in patients receiving daily doses of 1000 mg levofloxacin”.
Za sistemsko uporabljena zdravila, ki vsebujejo levofloksacin, mora navedba o dejavnikih tveganja v prvem zgoraj navedenem stavku dodatno vsebovati »pri bolnikih, ki prejemajo dnevne odmerke 1000 mg levofloksacina«.
Section 2 Warnings and precautions
Poglavje 2: Opozorila in previdnostni ukrepi
Note: the indications are grouped under headings or cover terms that encompass the same medical entity; all changes apply to both the cover term and sub-headings, as relevant.
Opomba: indikacije so združene pod naslovi ali skupnimi izrazi za enaka zdravstvena stanja; vse spremembe se nanašajo na oboje, na skupni izraz in podnaslove, kot je ustrezno.
Your risk is increased if you are elderly (above 60 years of age), have received an organ transplant, have kidney problems or if you are being treated with corticosteroids.
Tveganje je povečano, če ste starejši (stari več kot 60 let), so vam presadili organ, imate težave z ledvicami ali se zdravite s kortikosteroidi.
Inflammation and ruptures of tendons may occur within the first 48 hours of treatment and even up to several months after stopping of <product name> therapy.
Vnetje in pretrganja kit se lahko pojavijo že v prvih 48 urah zdravljenja, lahko pa tudi več mesecev po prenehanju zdravljenja z zdravilom <ime zdravila>.
These infections include cystitis,
Te okužbe vključujejo cistitis,
• Sepsis due to above-mentioned genito-urinary infections
• Sepsa zaradi zgoraj omenjenih genitourinarnih okužb
These amendments to the relevant sections of the product information are the outcome of the referral procedure.
Te spremembe ustreznih poglavij informacij o zdravilu so bile dogovorjene v postopku napotitve.
In addition of the amendments recommended below, the following sentence should be included in all quinolones and fluoroquinolones containing medicinal products at the end of section 4.1:
Poleg spodaj priporočenih sprememb je treba pri vseh zdravilih, ki vsebujejo kinolone in fluorokinolone, na koncu poglavja 4.1 vključiti naslednji stavek:
• Acute and chronic prostatitis, including severe forms
• Akutni in kronični prostatitis, vključno s hudimi oblikami
The use of [INN] should be avoided in patients who have experienced serious adverse reactions in the past when using quinolone or fluoroquinolone containing products (see section 4.8).
Uporabi [INN] se je treba izogibati pri bolnikih, pri katerih so se v preteklosti med uporabo zdravil, ki vsebujejo kinolone ali fluorokinolone, pojavili resni neželeni učinki (glejte poglavje 4.8).
Tuberculosis, in combination treatment
• Tuberkuloza, pri kombiniranem zdravljenju
The current warning statement on tendinopathies/tendon disorders should be amended with regard to risk factors, time to onset and need for monitoring of patients and should include at least the following information (or added as new statement if missing):
Trenutni opozorilni stavek o tendinopatijah/poškodbah kit je treba popraviti glede dejavnikov tveganja, časa do pojava in potrebe po spremljanju bolnikov, in mora vključevati vsaj naslednje informacije (ali ga dodati kot novo besedilo, če manjka):
Corticosteroids should not be used if signs of tendinopathy occur.
Če se pojavijo znaki tendinopatije, se ne sme uporabiti kortikosteroidov.