FrancophonIA/ELRC3.0 huggingface dataset:
English: Repeated administration of “product name” (to be completed nationally) leads to slight bioaccumulation of benazeprilat (R=1.47 in dogs and R=1.36 in cats with 0.5 mg/kg), steady state being achieved within a few days (4 days in dogs).
Slovenian: Večkratna uporaba „ime izdelka” (dopolniti na nacionalni ravni) vodi v rahlo bioakumulacijo benazeprilata (R = 1,47 pri psih in R = 1,36 pri mačkah z 0,5 mg/kg), pri čemer je dinamično ravnovesje doseženo v nekaj dneh (4 dni pri psih).
English: Grounds for amendment of the summaries of product characteristics, labelling and package leaflets
Slovenian: Razlogi za spremembo povzetka glavnih značilnosti zdravila, označevanja in navodila za uporabo
English: In cats with experimental renal insufficiency,“product name” (to be completed nationally) normalized the elevated glomerular capillary pressure and reduced the systemic blood pressure.
Slovenian: Pri mačkah z eksperimentalno ledvično odpovedjo je „ime izdelka” (dopolniti na nacionalni ravni) normaliziral povišani glomerularni kapilarni pritisk in zmanjšal sistemski krvni pritisk.
English: After oral administration of benazepril hydrochloride, peak levels of benazepril are attained rapidly (Tmax 0.5 hour in dogs) and decline quickly as the active substance is partially metabolised by liver enzymes to benazeprilat.
Slovenian: Po peroralni uporabi benazepril hidroklorida so najvišje ravni benazeprila hitro dosežene (tmax 0,5 ure pri psih) in hitro upadejo, ker jetrni encimi zdravilo delno presnovijo v benazeprilat.
English: In dogs with congestive heart failure, the dose may be doubled, still administered once daily, to a minimum dose of 0.5 mg (range 0.5-1.0) benazepril hydrochloride/kg body weight if judged necessary and advised by the veterinary surgeon.
Slovenian: Pri psih s kongestivnim srčnim popuščanjem se lahko odmerek podvoji, še vedno se ga daje enkrat dnevno, do najmanjšega odmerka 0,5 mg (razpon 0,5 - 1,0) benazepril hidroklorida/kg telesne mase, če veterinar presodi, da je to potrebno.
English: Tablets for cats and dogs
Slovenian: Tablete za mačke in pse.
English: “Product name” (to be completed nationally) reduced erythrocyte counts in normal dogs when dosed at 150 mg/kg body weight once daily for 12 months, but this effect was not observed at the recommended dose during clinical trials in dogs.
Slovenian: „Ime izdelka” (dopolniti na nacionalni ravni) je zmanjšal število eritrocitov pri zdravih psih v odmerku 150 mg/kg enkrat dnevno 12 mesecev, vendar tega učinka ni bilo opaziti pri priporočenem odmerku v kliničnih preizkusih pri psih.
English: Dog: Treatment of heart failure, especially dilated cardiomyopathy and mitral failure.
Slovenian: Pes: Zdravljenje srčnega popuščanja, še posebej dilatativne kardiomiopatije in popuščanja mitralne zaklopke.
English: Therefore, the use of Fortekor during pregnancy and lactation should be contraindicated in cats (and dogs) appropriate text should be added to the relevant sections of the product information.
Slovenian: Poleg tega je zdravljenje z zaviralci ACE kontraindicirano med brejostjo in laktacijo, zato mora biti uporaba zdravila Fortekor med brejostjo in laktacijo pri mačkah (in psih) kontraindicirana, v ustrezna poglavja informacij o zdravilu pa se doda ustrezno besedilo.
English: 2,5 mg Tablets
Slovenian: 2,5 mg Tablete
English: Transient reversible hypotension (low blood pressure) may occur in cases of accidental overdose.
Slovenian: V primeru nenamernega prevelikega odmerjanja se lahko pojavi prehodna reverzibilna hipotenzija (nizek krvni pritisk).
English: Summaries of product characteristics, labelling and package leaflets
Slovenian: Povzetki glavnih značilnosti zdravil, označevanja in navodila za uporabo
English: Cardiac failure in dogs, chronic renal insufficiency in cats
Slovenian: Srčno popuščanje pri psih, kronična ledvična insuficienca pri mačkah
English: “Product name”2.5 mg (to be completed nationally) 1 tablet 2 tablets
Slovenian: „Ime izdelka” 2,5 mg (dopolniti na nacionalni ravni) 1 tableta 2 tableti
English: Repeated administration of “product name” (to be completed nationally) leads to slight bioaccumulation of benazeprilat (R=1.47 in dogs with 0.5 mg/kg), steady state being achieved within a few days (4 days in dogs).
Slovenian: Večkratna uporaba „ime izdelka” (dopolniti na nacionalni ravni) vodi v rahlo bioakumulacijo benazeprilata (R = 1,47 pri psih z 0,5 mg/kg), pri čemer je dinamično ravnovesje doseženo v nekaj dneh (4 dni pri psih).
English: Luxembourg Novartis Consumer Health B.V.
Slovenian: Luksemburg Novartis Consumer Health B.V.
English: For cats -Treatment of chronic renal insufficiency
Slovenian: Za mačke - Zdravljenje kronične ledvične insuficience
English: “Product name” 5 mg (to be completed nationally ) 0.5 tablet 1 tablet
Slovenian: „Ime izdelka” 5 mg (dopolniti na nacionalni ravni) 0,5 tablete 1 tableta
English: 2.5 mg Tablets
Slovenian: 2.5 mg Tablete
English: MARKETING AUTHORISATION HOLDER To be completed nationally.
Slovenian: IMETNIK DOVOLJENJA ZA PROMET Dopolniti na nacionalni ravni.
English: Cats: Treatment of chronic renal insufficiency.
Slovenian: Mačke: Zdravljenje kronične ledvične insuficience.
English: “Product name” (to be completed nationally) causes long-lasting inhibition of plasma ACE activity, with more than 95% inhibition at peak effect and significant activity (>80% in dogs) persisting 24 hours after dosing.
Slovenian: „Ime izdelka” (dopolniti na nacionalni ravni) povzroči dolgotrajno zaviranje plazemske aktivnosti ACE pri psih z več kot 95-odstotno inhibicijo pri največjem učinku in opazno aktivnost (> 80 % pri psih), ki deluje 24 ur po odmerjanju.
English: Treatment of heart failure
Slovenian: Zdravljenje srčnega popuščanja
English: “Product name” 20 mg (to be completed nationally)
Slovenian: „Ime izdelka” 20 mg (dopolniti na nacionalni ravni)
English: Vomiting, poor appetite, dehydration, lethargy and diarrhoea have been reported on rare occasions in cats.
Slovenian: V redkih primerih so se pri mačkah pojavili bruhanje, zmanjšan apetit, dehidracija, letargija in diareja.
English: No evidence of renal toxicity of the veterinary medicinal product has been observed (in dogs or cats) during clinical trials, however, as is routine in cases of chronic kidney disease, it is recommended to monitor plasma creatinine, urea and erythrocyte counts during therapy.
Slovenian: Posebni previdnostni ukrepi za uporabo pri živalih V kliničnih preizkusih ni bilo dokazov o toksičnem učinku zdravila na ledvice (pri psih in mačkah), vendar pa je priporočljivo spremljanje plazemskih koncentracij kreatinina, sečnine in števila eritrocitov med zdravljenjem, kar je rutinski postopek v primerih kronične ledvične bolezni.
English: It is prescribed by the veterinary surgeon for the treatment of congestive heart failure in dogs.
Slovenian: Predpiše ga veterinar za zdravljenje kongestivnega srčnega popuščanja pri psih.
English: Placebo controlled clinical field studies in cats with chronic kidney disease (CKD) have demonstrated that “Product name” (to be completed nationally) significantly reduced levels of urine protein and urine protein to creatinine ratio (UPC); this effect is probably mediated via reduced glomerular hypertension and beneficial effects on the glomerular basement membrane.
Slovenian: S placebom nadzorovane klinične študije na terenu pri mačkah s kronično ledvično boleznijo (KLB) so pokazale, da je „ime izdelka” (dopolniti na nacionalni ravni) občutno zmanjšal ravni beljakovin v seču in urinsko beljakovinsko-kreatininsko razmerje (UPC); ta učinek se je najbrž pojavil zaradi zmanjšane glomerularne hipertenzije in ugodnega vpliva na glomerularno bazalno membrano.
English: Treatment of chronic renal insufficiency in cats.
Slovenian: Zdravljenje kronične ledvične insuficience pri mačkah.
English: Slow down of the progression of renal damage in chronic kidney disease with proteinuria.
Slovenian: Upočasnitev napredovanja poškodb ledvic pri kronični ledvični bolezni s proteinurijo.
English: In contrast with other ACE inhibitors, benazeprilat is excreted equally by both biliary and urinary routes in dogs, and therefore no adjustment of the dose of “product name” (to be completed nationally) is necessary in the treatment of cases with renal insufficiency.
Slovenian: Za razliko od drugih zaviralcev ACE se benazeprilat izloča enakovredno tako prek žolčne kot prek sečne poti pri psih, zaradi česar odmerka „ime izdelka” (dopolniti na nacionalni ravni) v primeru ledvične insuficience ni treba prilagajati.
English: For slowing the renal damage progression in chronic kidney disease with proteinuria.
Slovenian: Za upočasnitev napredovanja poškodb ledvic pri kronični ledvični bolezni s proteinurijo.
English: Double dose
Slovenian: Preveliko odmerjanje
English: Emesis, anorexia, dehydration, lethargy and diarrhoea have been reported in rare occasions in cats.
Slovenian: V redkih primerih so se pri mačkah pojavili bruhanje, anoreksija, dehidracija, letargija in diareja.
English: Heart diseases in dogs
Slovenian: Bolezni srca pri psih
English: Treatment of chronic renal insufficiency in cats
Slovenian: Zdravljenje kronične ledvične insuficience pri mačkah
English: “Product name” 2.5 mg (to be completed nationally )
Slovenian: „Ime izdelka” 2,5 mg (dopolniti na nacionalni ravni)
English: No evidence of renal toxicity of the veterinary medicinal product has been observed in dogs during clinical trials, however, as is routine in cases of chronic kidney disease, it is recommended to monitor plasma creatinine, urea and erythrocyte counts during therapy.
Slovenian: Posebni previdnostni ukrepi za uporabo pri živalih V kliničnih preizkusih ni bilo dokazov o toksičnem učinku zdravila na ledvice pri psih, vendar pa je priporočljivo spremljanje plazemskih koncentracij kreatinina, sečnine in števila eritrocitov med zdravljenjem, kar je rutinski postopek v primerih kronične ledvične bolezni.
English: Belgium Novartis Consumer Health B.V.
Slovenian: Novartis Consumer Health B.V.
English: For dogs -Treatment of heart failure
Slovenian: Za pse - Zdravljenje srčnega popuščanja
English: For dogs over 20 kg Treatment of heart failure
Slovenian: Za pse nad 20 kg Zdravljenje srčnega popuščanja
English: 20 mg Film-coated tablets
Slovenian: 20 mg Filmsko obložene tablete
English: SPECIAL STORAGE PRECAUTIONS Keep out of the reach and sight of children.
Slovenian: POSEBNA NAVODILA ZA SHRANJEVANJE Zdravilo shranjujte nedosegljivo otrokom.
English: “Product name” 5 mg (to be completed nationally )
Slovenian: „Ime izdelka” 5 mg (dopolniti na nacionalni ravni)
English: Novartis Consumer Health BV
Slovenian: Nizozemska Novartis Consumer Health BV
English: Dogs: Treatment of heart failure.
Slovenian: Psi: Zdravljenje srčnega popuščanja.
English: The safety of “product name” (to be completed nationally) has not been established in breeding, pregnant or lactating dogs.
Slovenian: Varnost „ime izdelka” (dopolniti na nacionalni ravni) ni bila ugotovljena pri psih, namenjenih za vzrejo, ter v obdobju brejosti ali laktacije.
English: The safety of “product name” (to be completed nationally) has not been established in breeding, pregnant or lactating dogs or cats.
Slovenian: Varnost „ime izdelka” (dopolniti na nacionalni ravni) ni bila ugotovljena pri psih in mačkah, namenjenih za vzrejo, ter v obdobju brejosti ali laktacije.
English: Film-coated tablets for cats and dogs
Slovenian: Filmsko obložene tablete za mačke in pse.
English: Dogs: Treatment of heart failure in dogs.
Slovenian: Psi: Zdravljenje srčnega popuščanja pri psih.
English: Dogs: Treatment of heart failure
Slovenian: Psi: Zdravljenje srčnega popuščanja
English: It is recommended to monitor plasma potassium levels when using “product name” (to be completed nationally) in combination with a potassium sparing diuretic because of the risk of hyperkalaemia.
Slovenian: Pri uporabi „ime izdelka” (dopolniti na nacionalni ravni) v kombinaciji z diuretikom, ki zadržuje kalij, je priporočljivo spremljanje ravni kalija v plazmi zaradi tveganja hiperkalemije.
English: For dogs over 5 kg Treatment of heart failure
Slovenian: Za pse nad 5 kg Zdravljenje srčnega popuščanja
English: Treatment of heart failure in dogs
Slovenian: Zdravljenje srčnega popuščanja pri psih
English: In a clinical trial in cats with chronic kidney disease, “Product name” (to be completed nationally) significantly reduced protein loss in the urine; this effect is probably mediated via reduced glomerular hypertension and beneficial effects on the glomerular basement membrane.
Slovenian: Klinična študija pri mačkah s kronično ledvično boleznijo (KLB) je pokazala, da je „ime izdelka” (dopolniti na nacionalni ravni) občutno zmanjšal izgubo beljakovin v seču; ta učinek se je najbrž pojavil zaradi zmanjšane glomerularne hipertenzije in ugodnega vpliva na glomerularno bazalno membrano.
English: For dogs over 2.5 kg Treatment of heart failure
Slovenian: Za pse nad 2,5 kg Zdravljenje srčnega popuščanja
English: For treatment of congestive heart failure in dogs.
Slovenian: Za zdravljenje kongestivnega srčnega popuščanja pri psih.
English: The clearance of benazeprilat is not affected in dogs or cats with impaired renal function and therefore no adjustment of “product name” (to be completed nationally) dose is required in either species in cases of renal insufficiency.
Slovenian: Pri psih in mačkah z okvarami delovanja ledvic ni težav pri očistku benazeprilata, zaradi česar odmerka „ime izdelka” (dopolniti na nacionalni ravni) v primeru ledvične insuficience ni treba prilagajati pri nobeni izmed vrst.
English: The clearance of benazeprilat is not affected in dogs with impaired renal function and therefore no adjustment of “product name” (to be completed nationally) dose is required in either species in cases of renal insufficiency.
Slovenian: Pri psih z okvarami delovanja ledvic ni težav pri očistku benazeprilata, zaradi česar odmerka „ime izdelka” (dopolniti na nacionalni ravni) v primeru ledvične insuficience ni treba prilagajati pri nobeni izmed vrst.
English: STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S) Each tablet contains 20 mg benazepril hydrochloride.
Slovenian: NAVEDBA ZDRAVILNE(IH) UČINKOVIN(E) IN DRUGIH SNOVI Vsaka tableta vsebuje 20 mg benazepril hidroklorida.
English: STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S) Each tablet contains 2.5 mg benazepril hydrochloride.
Slovenian: NAVEDBA ZDRAVILNE(IH) UČINKOVIN(E) IN DRUGIH SNOVI Vsaka tableta vsebuje 2,5 mg benazepril hidroklorida.
English: DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED To be completed nationally.
Slovenian: DATUM ZADNJE ODOBRITVE NAVODIL ZA UPORABO Dopolniti na nacionalni ravni.
English: Novartis Animal Health S.p.A. largo Boccioni 1 21040 Origgio (VA) Italy
Slovenian: 21040 Origgio (VA) Italija
English: STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S) Each film-coated tablet contains 20 mg benazepril hydrochloride
Slovenian: NAVEDBA ZDRAVILNE(IH) UČINKOVIN(E) IN DRUGIH SNOVI Vsaka filmsko obložena tableta vsebuje 20 mg benazepril hidroklorida.
English: Av.Mesogeion 198
Slovenian: Empresarial, Edifício 8
English: INDICATIONS For treatment of congestive heart failure in dogs.
Slovenian: INDIKACIJA(E) Za zdravljenje kongestivnega srčnega popuščanja pri psih.
English: STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S) Each film-coated tablet contains 5 mg benazepril hydrochloride
Slovenian: NAVEDBA ZDRAVILNE(IH) UČINKOVIN(E) IN DRUGIH SNOVI Vsaka filmsko obložena tableta vsebuje 5 mg benazepril hidroklorida.
English: Treatment of heart failure in dogs.
Slovenian: Zdravljenje srčnega popuščanja pri psih.
English: Film-coated tablets for dogs
Slovenian: Filmsko obložene tablete za pse.
English: Cats: “Product name” (to be completed nationally) should be administered orally at a minimum dose of 0.5 mg (range 0.5-1.0) benazepril hydrochloride/kg body weight once daily according to the following table:
Slovenian: Mačke: „Ime izdelka” (dopolniti na nacionalni ravni) je treba jemati peroralno v minimalnem odmerku 0,5 mg (razpon 0,5 - 1,0) benazepril hidroklorida/kg telesne mase enkrat dnevno v skladu z naslednjo tabelo:
English: In cats “product name” (to be completed nationally) should be administered orally at a minimum dose of 0.5 mg (range 0.5-1.0) benazepril hydrochloride/kg body weight once daily according to the following table:
Slovenian: Pri mačkah je treba „ime izdelka” (dopolniti na nacionalni ravni) dajati peroralno v minimalnem odmerku 0,5 mg (razpon 0,5 - 1,0) benazepril hidroklorida/kg telesne mase enkrat dnevno v skladu z naslednjo tabelo:
English: An ad-hoc expert group (AHEG) was consulted regarding the scientific evidence base for ACEI in the treatment of chronic kidney disease in dogs.
Slovenian: V zvezi z bazo znanstvenih dokazov za zaviralce ACE pri zdravljenju kronične bolezni ledvic pri psih so za nasvet zaprosili začasno strokovno skupino.
English: For treatment of heart failure in dogs.
Slovenian: Za zdravljenje srčnega popuščanja pri psih.
English: STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S) Each tablet contains 5 mg benazepril hydrochloride
Slovenian: NAVEDBA ZDRAVILNE(IH) UČINKOVIN(E) IN DRUGIH SNOVI Vsaka tableta vsebuje 5 mg benazepril hidroklorida.
English: Dogs: “Product name” (to be completed nationally) should be administered orally at a minimum dose of 0.25 mg (range 0.25-0.5) benazepril hydrochloride/kg body weight once daily, according to the following table:
Slovenian: Psi: „Ime izdelka” (dopolniti na nacionalni ravni) je treba dajati peroralno v minimalnem odmerku 0,25 mg (razpon 0,25 - 0,5) benazepril hidroklorida/kg telesne mase enkrat dnevno v skladu z naslednjo tabelo:
English: In dogs “product name” (to be completed nationally) should be administered orally at a minimum dose of 0.25 mg (range 0.25-0.5) benazepril hydrochloride/kg body weight once daily, according to the following table:
Slovenian: Pri psih je treba „ime izdelka” (dopolniti na nacionalni ravni) dajati peroralno v minimalnem odmerku 0,25 mg (razpon 0,25 - 0,5) benazepril hidroklorida/kg telesne mase enkrat dnevno v skladu z naslednjo tabelo:
English: 6.5 Nature and composition of immediate packaging To be completed nationally.
Slovenian: 6.2 Inkompatibilnosti Dopolniti na nacionalni ravni.
English: This can cause problems for the man and may cause problems in sexual relationships.
Slovenian: To lahko moškemu povzroča težave in vodi tudi do težav pri spolnih odnosih.
English: • You notice any changes in your mood
Slovenian: • če opazite kakršnekoli spremembe v svojem razpoloženju
English: After the Commission decision the Member State competent authorities, in liaison with the reference Member State, will update the product information as required.
Slovenian: Po izdaji odločbe Evropske komisije bodo zadevne države članice, v sodelovanju z referenčno državo članico po potrebi posodobile informacije o zdravilu.
English: • Do not take Priligy if you are dehydrated (you do not have enough water in your body).
Slovenian: • Ne jemljite zdravila Priligy, če ste dehidrirani (ker takrat v telesu ni dovolj vode).
English: • Lower interest in sex
Slovenian: • manjše zanimanje za spolnost
English: • Priligy should not be used by either men under the age of 18 or men 65 years or older
Slovenian: • Zdravila Priligy ne smejo uporabljati moški, mlajši od 18 let ali starejši od 65 let.
English: Premature ejaculation is when a man ejaculates with little sexual stimulation and before the man wants.
Slovenian: Prezgodnja ejakulacija pomeni, da moški ejakulira že z malo spolne stimulacije in preden si to sam želi.
English: • The usual dose is 30 mg.
Slovenian: • Običajni odmerek je 30 mg.
English: Priligy is used to treat premature ejaculation, in men between 18 and 64 years old.
Slovenian: Zdravilo Priligy uporabljamo za zdravljenje prezgodnje ejakulacije pri moških, starih od 18 do 64 let.
English: • Problems sleeping or strange dreams
Slovenian: • težave s spanjem ali nenavadne sanje
English: • Loss of sex drive, problems reaching orgasm
Slovenian: • izguba spolne sle, težave z doseganjem orgazma
English: • Priligy can be taken with or without food.
Slovenian: • Zdravilo Priligy lahko jemljete s hrano ali brez nje.
English: • You drink alcohol (see section “Taking Priligy with food and drink”)
Slovenian: • če pijete alkohol (glejte poglavje “Jemanje zdravila Priligy skupaj s hrano in pijačo”)
English: This includes medicines you get without a prescription, such as herbal medicines.
Slovenian: Sem sodijo tudi zdravila, ki ste jih dobili brez recepta, na primer zdravila rastlinskega izvora.
English: If treatment is continued, you should see your doctor again to discuss this at least every six months.
Slovenian: Če boste nadaljevali z zdravljenjem morate zdravnika obiskati vsaj vsakih 6 mesecev.
English: • Nefazodone an antidepressant.
Slovenian: • nefazodon - antidepresiv.
English: Taking Priligy with food and drink
Slovenian: Jemanje zdravila Priligy skupaj s hrano in pijačo
English: Your doctor may increase the dose to 60 mg.
Slovenian: Zdravnik lahko odmerek zveča na 60 mg.
English: • You have not been diagnosed with premature ejaculation
Slovenian: • če vam ni bila postavljena diagnoza prezgodnje ejakulacije
English: • This medicinal product does not require any special storage conditions.
Slovenian: • Za shranjevanje zdravila niso potrebna posebna navodila.
English: This may help lower your chance of fainting (see ‘Fainting and low blood pressure' in section 4).
Slovenian: Tako boste lahko tudi zmanjšali verjetnost padca v nezavest (glejte poglavje ‘Omedlevica in nizek krvni tlak v Poglavju 4).
English: Therefore, use of other medicines may affect the maximum dose of Priligy you're allowed to take.
Slovenian: Uporaba drugih zdravil lahko vpliva na največji odmerek zdravila Priligy, ki ga smete vzeti.
English: This medicinal product is authorised in the Member States of the EEA under the following names:
Slovenian: Z dravilo je v državah članicah EGP pridobilo dovoljenje za promet z naslednjimi imeni:
English: If you experience any of these or similar effects, you should avoid driving or operating hazardous machinery.
Slovenian: Če se pojavi katerikoli od teh učinkov ali kakšen podoben učinek, se izogibajte vožnji ali upravljanju nevarnih strojev.
English: • Abnormal taste
Slovenian: • nenormalen okus
English: <{Name of the Member State}> <{Name of the medicinal product}>
Slovenian: {Ime države članice}> <{Ime zdravila}>
English: Talk to your doctor before you stop taking this medicine.
Slovenian: Posvetujte se s svojim zdravnikom, preden prenehate z jemanjem tega zdravila.
English: Do not take Priligy more than once every 24 hours.
Slovenian: Zdravila Priligy ne smete vzeti več kot enkrat na 24 ur.
English: Film-coated tablets 1 tablet
Slovenian: filmsko obložene tablete 1 tableta
English: • Discuss your Priligy treatment with your doctor after the first 4 weeks or after 6 doses to see whether you should continue treatment.
Slovenian: • Po prvih 4 tednih zdravljenja ali prvih 6 odmerkih se o zdravljenju pogovorite z zdravnikom, da ugotovite ali je treba z zdravljenjem nadaljevati.
English: • Tramadol used to treat serious pain
Slovenian: • tramadol, za zdravljenje hudih bolečin
English: You may feel sick or be sick.
Slovenian: Lahko vam bo slabo ali boste bruhali.
English: Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines as certain medicines may increase your risk of side effects.
Slovenian: Obvestite svojega zdravnika ali farmacevta, če jemljete ali ste pred kratkim jemali katerokoli zdravilo, ker lahko določena zdravila zvečajo tveganje za neželene učinke.
English: Therefore, this SmPC, labelling and package leaflet may not necessarily represent the current text.
Slovenian: Zato ni nujno, da ta SmPC, označevanje in navodilo za uporabo odražajo trenutno veljavno besedilo.
English: • Slow or irregular heartbeat or increase in heart rate
Slovenian: • počasen ali nepravilen srčni utrip oziroma povečanje srčne frekvence
English: • You have moderate or severe liver problems.
Slovenian: • če imate zmerne ali hude težave z jetri.
English: Note: This SmPC, labelling and packages leaflet is the version valid at the time of Commission decision.
Slovenian: Opomba: ta različica SmPC, označevanja in navodila za uporabo je veljala ob izdaji odločbe Evropske komisije.