FrancophonIA/ELRC3.0 huggingface dataset:
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING BOTTLE LABEL(40 mg/ml powder for oral suspension - 60 ml bottle)
Slovenian: PODATKI, KI MORAJO BITI NAVEDENI NA PRIMARNI OVOJNINI OZNAČBA NA PLASTENKI (40 mg/ml prašek za peroralno suspenzijo - 60 ml plastenka)
English: INFORMATION IN BRAILLE Diflucan and associated names (see Annex I) 10 mg/ml [To be completed nationally]
Slovenian: PODATKI V BRAILLOVI PISAVI Diflucan in povezana imena (glejte Prilogo I) 10 mg/ml [izpolni država članica]
English: • Mucosal candidiasis including oropharyngeal, oesophageal candidiasis, candiduria and chronic mucocutaneous candidiasis.
Slovenian: • Kandidoze sluznic, vključno s kandidozo ustne votline in žrela, kandidoze požiralnika,
English: Abdominal pain, vomiting, diarrhoea, nausea
Slovenian: Bolečine v trebuhu, bruhanje, driska, navzea
English: 150 mg as a single dose
Slovenian: 150 mg v enkratnem odmerku
English: NAME OF THE MEDICINAL PRODUCT Diflucan and associated names (see Annex I) 150 mg hard capsules [See Annex I - To be completed nationally]
Slovenian: Diflucan in povezana imena (glejte Dodatek I) 150 mg trde kapsule [glejte Dodatek I - Izpolni država članica]
English: INFORMATION IN BRAILLE Diflucan and associated names (see Annex I) 40 mg/ml [To be completed nationally]
Slovenian: PODATKI V BRAILLOVI PISAVI Diflucan in povezana imena (glejte Prilogo I) 40 mg/ml [izpolni država članica]
English: Marketing Authorisation Holder and Manufacturer [See Annex I - To be completed nationally]
Slovenian: Imetnik dovoljenja za promet z zdravilom in izdelovalec [glejte dodatek I - Izpolni država članica]
English: - red or purple discoloration of the skin which may be caused by low platelet count, other blood cell changes - blood chemistry changes (high blood levels of cholesterol, fats) - low blood potassium, - shaking - abnormal electrocardiogram (ECG), change in heart rate or rhythm - liver failure - allergic reactions (sometimes severe), including widespread blistering rash and skin peeling,
Slovenian: - nizka koncentracija kalija v krvi - spremembe v kemijski sestavi krvi (visoke ravni holesterola in maščob v krvi) - tresavica - nenormalen elektrokardiogram (EKG), spremembe v hitrosti srčnega utripa ali pri ritmu delovanja srca - odpoved delovanja jeter - alergijske reakcije (včasih hude), vključno z obsežnimi mehurjastimi izpuščaji in luščenjem kože, hude kožne reakcije, otekanje ustnic ali obraza - izpadanje las
English: You might be given this medicine by your doctor to treat the following types of fungal infections: - Cryptococcal meningitis - a fungal infection in the brain - Coccidioidomycosis - a disease of the bronchopulmonary system - Infections caused by Candida and found in the blood stream, body organs (e.g. heart, lungs) or urinary tract - Mucosal thrush - infection affecting the lining of the mouth, throat and denture sore mouth
Slovenian: - Kriptokokni meningitis - glivična okužba v možganih - Kokcidioidomikoza - bolezen bronhopulmonalnega sistema - Okužbe, povzročene s kandido, ugotovljene v krvnem obtoku, telesnih organih (npr. srce,
English: Coadministration of fluconazole and erythromycin is contraindicated (see section 4.3).
Slovenian: Sočasna uporaba flukonazola in eritromicina je kontraindicirana (glejte poglavje 4.3).
English: Saquinavir: Fluconazole increases the AUC and C max of saquinavir with approximately 50% and 55% respectively, due to inhibition of saquinavir's hepatic metabolism by CYP3A4 and inhibition of P-glycoprotein.
Slovenian: Sakvinavir: Zaradi zavrtja presnove sakvinavirja s CYP3A4 v jetrih in zavrtja P-glikoproteina flukonazol poveča AUC sakvinavirja za približno 50 % in Cmax za približno 55 %.
English: STATEMENT OF ACTIVE SUBSTANCE(S) 1 ml of oral solution contains 5 mg of fluconazole.
Slovenian: NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN 1 ml peroralne raztopine vsebuje 5 mg flukonazola.
English: GENERAL CLASSIFICATION FOR SUPPLY [To be completed nationally]
Slovenian: NAČIN IZDAJANJA ZDRAVILA [izpolni država članica]
English: The signs of liver problems include: tiredness loss of appetite vomiting yellowing of your skin or the whites of your eyes (jaundice) If any of these happen, stop taking Diflucan and tell your doctor immediately.
Slovenian: Simptomi težav z jetri so naslednji: - utrujenost - izguba apetita - bruhanje - porumenelost kože ali očesnih beločnic (zlatenica).
English: Adjustment of dose of NSAIDs may be needed.
Slovenian: Potrebna je lahko prilagoditev odmerka nesteroidnih protivnetnih zdravil.
English: Diflucan and associated names (see Annex I) 50 mg Diflucan and associated names (see Annex I) 100 mg Diflucan and associated names (see Annex I) 150 mg Diflucan and associated names (see Annex I) 200 mg [To be completed nationally]
Slovenian: Diflucan in povezana imena (glejte Prilogo I) 50 mg, Diflucan in povezana imena (glejte Prilogo I) 100 mg, Diflucan in povezana imena (glejte Prilogo I) 150 mg, Diflucan in povezana imena (glejte Prilogo I) 200 mg
English: PACKAGE LEAFLET: INFORMATION FOR THE USER Diflucan and associated names (see Annex I) 150 mg capsule [See Annex I - To be completed nationally] fluconazole
Slovenian: NAVODILO ZA UPORABO Diflucan in povezana imena (glejte dodatek I) 150 mg trde kapsule [glejte dodatek I - Izpolni država članica] flukonazol
English: NAME OF THE MEDICINAL PRODUCT Diflucan and associated names (see Annex I) 10 mg/ml powder for oral suspension [See Annex I - To be completed nationally]
Slovenian: Diflucan in povezana imena (glejte Prilogo I) 10 mg/ml prašek za peroralno suspenzijo [glejte Prilogo I - izpolni država članica]
English: To stop mucosal infections of mouth and throat from coming back
Slovenian: Za preprečitev ponovitve okužbe sluznice ustne votline in grla
English: Hepatic failure (see section 4.4), hepatocellular necrosis (see section 4.4), hepatitis (see section 4.4), hepatocellular damage (see section phosphatase increased (see section 4.4)
Slovenian: Odpoved delovanja jeter (glejte poglavje 4.4), nekroza jetrnih celic (glejte poglavje 4.4), hepatitis (glejte poglavje 4.4), poškodba jetrnih celic (glejte poglavje 4.4)
English: Titanium dioxide (E171) Patent blue V (E131)
Slovenian: 150 mg kapsule želatina titanov dioksid (E171) patentno modro barvilo V (E131)
English: NAME OF THE MEDICINAL PRODUCT Diflucan and associated names (see Annex I) 40 mg/ml powder for oral suspension [See Annex I - To be completed nationally]
Slovenian: Diflucan in povezana imena (glejte Prilogo I) 40 mg/ml prašek za peroralno suspenzijo [glejte Prilogo I - izpolni država članica]
English: 1 bottle - 35 ml suspension after reconstitution
Slovenian: FARMACEVTSKA OBLIKA IN VSEBINA prašek za peroralno suspenzijo 1 plastenka - 35 ml suspenzije po rekonstituciji
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each hard capsule contains fluconazole 150 mg.
Slovenian: NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Ena trda kapsula vsebuje 150 mg flukonazola.
English: NAME OF THE MEDICINAL PRODUCT Diflucan and associated names (see Annex I) 2 mg/ ml solution for infusion [See Annex I - To be completed nationally] Fluconazole
Slovenian: Diflucan in povezana imena (glejte dodatek I) 2 mg/ml raztopina za infundiranje [glejte dodatek I - Izpolni država članica] flukonazol
English: They have “FLU-150” and “Pfizer” with black ink printed on them.
Slovenian: Na obeh je s črnilom črne barve natisnjeno "FLU-150" in "Pfizer".
English: (Powder for oral suspension (175 ml bottle): Store below 25°C.
Slovenian: Prašek za peroralno suspenzijo (175 ml plastenka): Shranjujte pri temperaturi do 25 °C.
English: - rifampicin or rifabutin (antibiotics for infections) - alfentanil, fentanyl (used as anaesthetic) - amitriptyline, nortriptyline (used as anti-depressant) - amphotericin B, voriconazole (anti-fungal) - medicines that thin the blood to prevent blood clots (warfarin or similar medicines) - benzodiazepines (midazolam, triazolam or similar medicines) used to help you sleep or for anxiety - carbamazepine, phenytoin (used for treating fits) - nifedipine, isradipine, amlodipine felodipine and losartan (for hypertension- high blood pressure) - ciclosporin, everolimus, sirolimus or tacrolimus (to prevent transplant rejection) - cyclosphosphamide, vinca alkaloids (vincristine, vinblastine or similar medicines) used for treating cancer - halofantrine (used for treating malaria) - statins (atorvastatin, simvastatin and fluvastatin or similar medicines) used for reducing high cholesterol levels - methadone (used for pain) - celecoxib, flurbiprofen, naproxen, ibuprofen, lornoxicam, meloxicam, diclofenac
Slovenian: - rifampicin ali rifabutin (antibiotika za zdravljenje okužb) - alfentanil, fentanil (uporabljata se kot anestetika) - amitriptilin, nortriptilin (uporabljata se kot antidepresiva) - amfotericin B, vorikonazol (protiglivični zdravili) - zdravila, ki redčijo kri, da preprečijo nastajanje krvnih strdkov (varfarin ali podobna zdravila) - benzodiazepini (midazolam, triazolam ali podobna zdravila), ki se uporabljajo kot uspavala ali za zdravljenje tesnobe - karbamazepin, fenitoin (uporabljata se za zdravljenje konvulzij (napadi podobni epileptičnim)) - nifedipin, isradipin, amlodipin, felodipin in losartan (za zdravljenje hipertenzije - visokega krvnega tlaka) - ciklosporin, everolimus, sirolimus ali takrolimus (za preprečevanje zavrnitve presajenih organov) - ciklofosfamid, alkaloidi vinke (vinkristin, vinblastin ali podobna zdravila), ki se uporabljajo za zdravljenje rakavih obolenj - halofantrin (uporablja se za zdravljenje malarije) - statini (atorvastatin, simvastatin in fluvastatin ali podobna zdravila), ki se uporabljajo pri zdravljenju visokih ravni holesterola - metadon (uporablja se pri bolečinah) - celekoksib, flurbiprofen, naproksen, ibuprofen, lornoksikam, meloksikam, diklofenak
English: STATEMENT OF ACTIVE SUBSTANCE(S) 1 ml of reconstituted suspension contains 10 mg fluconazole.
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA 1 ml za uporabo pripravljene (rekonstituirane) suspenzije vsebuje 10 mg flukonazola.
English: HOW TO TAKE DIFLUCAN Always take your medicine exactly as your doctor has told you.
Slovenian: Pri jemanju zdravila Diflucan natančno upoštevajte zdravnikova navodila.
English: Diflucan is supplied as a solution.
Slovenian: Zdravilo Diflucan je na voljo v obliki raztopine.
English: You might also be given Diflucan to: - stop cryptococcal meningitis from coming back - stop mucosal trush from coming back - stop you from getting an infection caused by Candida (if your immune system is weak and not working properly)
Slovenian: - da bi preprečili ponovitev kriptokoknega meningitisa - da bi preprečili ponovitev okužbe sluznic - da bi preprečili, da bi pri vas prišlo do okužbe, ki jo povzroča kandida (v primeru, da je vaš imunski sistem oslabljen in ne deluje ustrezno)
English: This leaflet was last approved in
Slovenian: Navodilo je bilo odobreno:
English: NAME OF THE MEDICINAL PRODUCT Diflucan and associated names (see Annex I) 5 mg/ml oral solution [See Annex I - To be completed nationally]
Slovenian: Diflucan in povezana imena (glejte Dodatek I) 5 mg/ml peroralna raztopina [glejte Dodatek I - Izpolni država članica]
English: STATEMENT OF ACTIVE SUBSTANCE(S) 1 ml of reconstituted suspension contains 40 mg fluconazole.
Slovenian: NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN 1 ml rekonstituirane suspenzije vsebuje 40 mg flukonazola.
English: SPECIAL STORAGE CONDITIONS Powder for oral suspension (60 ml bottle): Store below 25°C Powder for oral suspension (175 ml bottle): Store below 25°C.
Slovenian: Prašek za peroralno suspenzijo (60 ml plastenka): Shranjujte pri temperaturi do 25 °C.
English: The 200 mg hard gelatin capsule has a white body and a purple cap overprinted with “Pfizer” and the code “FLU-200” with black ink.
Slovenian: Velikost kapsule je št. 1. 200 mg trda želatinska kapsula ima belo telo in vijoličasto kapico, na obeh pa je s črnilom črne barve natisnjena oznaka "Pfizer" in šifra "FLU-200".
English: NAME OF THE MEDICINAL PRODUCT Diflucan and associated names (see Annex I) 2 mg/ml solution for infusion [See Annex I - To be completed nationally]
Slovenian: Diflucan in povezana imena (glejte Dodatek I) 2 mg/ml raztopina za infundiranje [glejte Dodatek I - Izpolni država članica]
English: PACKAGE LEAFLET: INFORMATION FOR THE USER Diflucan and associated names (see Annex I) 5 mg/ml oral solution [See Annex I - To be completed nationally] fluconazole
Slovenian: NAVODILO ZA UPORABO Diflucan in povezana imena (glejte Dodatek I) 5 mg /ml peroralna raztopina [glejte Dodatek I - Izpolni država članica] flukonazol
English: They have “FLU-50” and “Pfizer” with black ink printed on them.
Slovenian: Na obeh je s črnilom črne barve natisnjeno "FLU-50" in "Pfizer".
English: Seizures, paraesthesia, dizziness, taste perversion
Slovenian: Tremor podobni epileptičnim), parestezija, omotica, motnje v zaznavanju okusa
English: Coadministration of fluconazole and quinidine is contraindicated (see section 4.3).
Slovenian: Sočasna uporaba flukonazola in kinidina je kontraindicirana (glejte poglavje 4.3).
English: PHARMACEUTICAL FORM AND CONTENTS Oral solution
Slovenian: FARMACEVTSKA OBLIKA IN VSEBINA peroralna raztopina
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE OF ADMINISTRATION Diflucan and associated names (see Annex I) 2 mg/ ml solution for infusion [See Annex I - To be completed nationally]
Slovenian: IME ZDRAVILA IN POT UPORABE ZDRAVILA Diflucan in povezana imena (glejte Prilogo I) 2 mg/ml raztopina za infundiranje [glejte Prilogo I - izpolni država članica] flukonazol intravenska uporaba
English: Diflucan and associated names (see Annex I) 50 mg capsules Diflucan and associated names (see Annex I) 100 mg capsules Diflucan and associated names (see Annex I) 150 mg capsules Diflucan and associated names (see Annex I) 200 mg capsules [See Annex I - To be completed nationally] fluconazole
Slovenian: Diflucan in povezana imena (glejte Dodatek I) 50 mg trde kapsule Diflucan in povezana imena (glejte Dodatek I) 100 mg trde kapsule Diflucan in povezana imena (glejte Dodatek I) 150 mg trde kapsule Diflucan in povezana imena (glejte Dodatek I) 200 mg trde kapsule [glejte dodatek I - Izpolni država članica] flukonazol
English: The 100 mg hard gelatin capsule has a white body and blue cap overprinted with “Pfizer” and the code “FLU-100” with black ink.
Slovenian: Velikost kapsule je št. 4. 100 mg trda želatinska kapsula ima belo telo in modro kapico, na obeh pa je s črnilom črne barve natisnjena oznaka "Pfizer" in šifra "FLU-100".
English: They have “FLU-100” and “Pfizer” with black ink printed on them.
Slovenian: Na obeh je s črnilom črne barve natisnjeno "FLU-100" in "Pfizer".
English: BATCH NUMBERS
Slovenian: ATC klasifikacija
English: Constipation disorders vomiting, diarrhoea, nausea dyspepsia, flatulence, dry mouth
Slovenian: spremembe v zaznavanju okusa - zaprtje, težave s prebavo, vetrovi, suha usta
English: You might be given this medicine by your doctor to treat the following types of fungal infections: - Mucosal thrush - infection affecting the lining of the mouth, throat - Infections caused by Candida and found in the blood stream, body organs (e.g. heart, lungs) or urinary tract - Cryptococcal meningitis - a fungal infection in the brain
Slovenian: - Glivična okužba sluznice - okužbo ustne sluznice ali grla - Okužbe, povzročene s kandido, ugotovljene v krvnem obtoku, telesnih organih (npr. srce,
English: Monitoring for voriconazole associated adverse events is recommended if voriconazole is used sequentially after fluconazole.
Slovenian: Če vorikonazol uporabimo po uporabi flukonazola, je treba bolnika spremljati glede pojava z vorikonazolom povezanih neželenih učinkov.
English: You might be given this medicine by your doctor to treat the following types of fungal infections: - Cryptococcal meningitis- a fungal infection in the brain - Coccidioidomycosis- a disease of the bronchopulmonary system - Infections caused by Candida and found in the blood stream, body organs (e.g. heart, lungs) or urinary tract - Mucosal thrush - infection affecting the lining of the mouth, throat and denture sore mouth - Genital thrush - infection of the vagina or penis - Skin infections - e.g. athlete's foot, ringworm, jock itch, nail infection
Slovenian: pljuča) ali sečilih - Glivična okužba sluznice - okužba ustne sluznice, žrela in bolečina v ustih zaradi zobne proteze - Glivična okužba spolovil - okužba nožnice ali penisa - Okužbe kože - npr. glivice med prsti na nogah (atletsko stopalo), lišaj, srbenje v dimljah,
English: BEFORE YOU TAKE DIFLUCAN
Slovenian: KAJ MORATE VEDETI, PREDEN BOSTE VZELI ZDRAVILO DIFLUCAN
English: Rare side effects which affect 1 to 10 users in 10,000 are listed below: - lower than normal white blood cells that help defend against infections and blood cells that help to stop bleeding - red or purple discoloration of the skin which may be caused by low platelet count, other blood cell changes - blood chemistry changes (high blood levels of cholesterol, fats) - low blood potassium - shaking - abnormal electrocardiogram (ECG), change in heart rate or rhythm - liver failure - allergic reactions (sometimes severe), including widespread blistering rash and skin peeling,
Slovenian: - število belih krvnih celic, ki pomagajo pri obrambi proti okužbam, in krvnih celic, ki pomagajo pri zaustavljanju krvavitev, je manjše od normalnega - rdeča ali škrlatna obarvanost kože, kar je lahko posledica majhnega števila krvnih ploščic, spremembe pri drugih krvnih celicah - nizka koncentracija kalija v krvi - spremembe v kemijski sestavi krvi (visoke ravni holesterola in maščob v krvi) - tresavica
English: Hepatic failure (see section 4.4), hepatocellular necrosis (see section 4.4), hepatitis (see section 4.4), hepatocellular damage (see section
Slovenian: Odpoved delovanja jeter (glejte poglavje 4.4), nekroza jetrnih celic (glejte poglavje 4.4), hepatitis (glejte poglavje 4.4), poškodba jetrnih celic (glejte poglavje
English: 100 mg to 200 mg daily or 200 mg 3 times per week.
Slovenian: - Kandidoza požiralnika 100 mg do 200 mg na dan ali 200 mg 3-krat na teden
English: Diflucan and associated names (see Annex I) 50 mg hard capsules Diflucan and associated names (see Annex I) 100 mg hard capsules Diflucan and associated names (see Annex I) 150 mg hard capsules Diflucan and associated names (see Annex I) 200 mg hard capsules [See Annex I - To be completed nationally]
Slovenian: Diflucan in povezana imena (glejte Prilogo I) 50 mg trde kapsule Diflucan in povezana imena (glejte Prilogo I) 100 mg trde kapsule Diflucan in povezana imena (glejte Prilogo I) 150 mg trde kapsule Diflucan in povezana imena (glejte Prilogo I) 200 mg trde kapsule [glejte Prilogo I - izpolni država članica]
English: Each ml contains 2 mg of fluconazole.
Slovenian: En ml raztopine za infundiranje vsebuje 2 mg flukonazola.
English: Diflucan and associated names (see Annex 1) 50 mg hard capsules Diflucan and associated names (see Annex 1) 100 mg hard capsules Diflucan and associated names (see Annex 1) 150 mg hard capsules Diflucan and associated names (see Annex 1) 200 mg hard capsules [See Annex I - To be completed nationally]
Slovenian: Diflucan in povezana imena (glejte Prilogo I) 50 mg trde kapsule Diflucan in povezana imena (glejte Prilogo I) 100 mg trde kapsule Diflucan in povezana imena (glejte Prilogo I) 150 mg trde kapsule Diflucan in povezana imena (glejte Prilogo I) 200 mg trde kapsule
English: 1 ml of reconstituted suspension contains 10 mg fluconazole.
Slovenian: NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN En ml rekonstituirane suspenzije vsebuje 10 mg flukonazola.
English: Important information about some of the ingredients of Diflucan Diflucan contains sucrose (sugar).
Slovenian: Zdravilo Diflucan vsebuje saharozo (sladkor).
English: Diflucan oral solution contains sucrose.
Slovenian: Zdravilo Diflucan peroralna raztopina vsebuje saharozo.
English: Plasma protein binding is low
Slovenian: Vezava na beljakovine v plazmi je majhna (11-12 %).
English: Longer periods may be used in patients with severely compromised immune function.
Slovenian: Pri bolnikih z močno oslabelim delovanjem imunskega sistema lahko zdravljenje traja dlje časa.
English: NAME OF THE MARKETING AUTHORISATION HOLDER [See Annex I - To be completed nationally]
Slovenian: IME IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM [glejte Prilogo I - izpolni država članica]
English: Fatigue, malaise, asthenia, fever
Slovenian: Utrujenost, splošno slabo počutje, astenija, zvišana telesna temperatura
English: - Each hard capsule contains fluconazole 150 mg. - The other ingredients are:
Slovenian: - Ena trda kapsula vsebuje 150 mg flukonazola.
English: This summary was last updated in 05-2010.
Slovenian: Povzetek je bil nazadnje posodobljen 05-2010.
English: A response is usually seen in two to four weeks.
Slovenian: Odziv se navadno opazi v dveh do štirih tednih.
English: • major depression;
Slovenian: • hudo depresivno motnjo;
English: The marketing authorisation holder is Eli Lilly Netherlands B.V.
Slovenian: Imetnik dovoljenja za promet je družba Eli Lilly Netherlands B.V.
English: The response to treatment should be assessed regularly.
Slovenian: Redno je treba ocenjevati odziv na zdravljenje.
English: The main measure of effectiveness was the change in the severity of pain each week.
Slovenian: Glavno merilo učinkovitosti je bila sprememba jakosti bolečine vsak teden.
English: Xeristar duloxetine
Slovenian: Xeristar duloksetin
English: The European Commission granted a marketing authorisation valid throughout the European Union for Xeristar on 17 December 2004.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Xeristar, veljavno po vsej Evropski uniji, odobrila dne 17. decembra 2004.
English: Xeristar is used to treat adults (aged 18 years or over) with the following diseases:
Slovenian: Zdravilo Xeristar se uporablja za zdravljenje odraslih (starih 18 let ali več) z naslednjimi boleznimi:
English: In both studies, pain reduction was seen from the first week of treatment for up to 12 weeks.
Slovenian: V obeh študijah je bilo zmanjšanje bolečine opaziti od prvega tedna zdravljenja do 12 tednov.
English: Other information about Xeristar:
Slovenian: Druge informacije o zdravilu Xeristar:
English: Treatment must not be started in patients with uncontrolled hypertension (high blood pressure), because of a risk of hypertensive crisis (sudden, dangerously high blood pressure).
Slovenian: Zdravljenje se ne sme uvesti pri bolnikih z nenadzorovano hipertenzijo (visokim krvnim tlakom) zaradi tveganja hipertenzivne krize (nenadnega, nevarno visokega krvnega tlaka).
English: This document is a summary of the European Public Assessment Report (EPAR) for Xeristar.
Slovenian: Ta dokument je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Xeristar.
English: Since these neurotransmitters are involved in maintaining high mood and reducing the sensation of pain, blocking their re-uptake into nerve cells can improve the symptoms of depression, anxiety and neuropathic pain.
Slovenian: Ker ti živčni prenašalci sodelujejo pri ohranjanju dobrega razpoloženja in zmanjševanju občutka bolečine, lahko zaviranje njihovega prevzema v živčne celice izboljša simptome depresije, anksioznosti in bolečine nevropatije.
English: The most common side effects with Xeristar (seen in more than 1 patient in 10) are nausea (feeling sick), headache, dry mouth, somnolence (sleepiness) and dizziness.
Slovenian: Najpogostejši neželeni učinki zdravila Xeristar (opaženi pri več kot 1 bolniku od 10) so navzeja (slabost), glavobol, suha usta, somnolenca (zaspanost) in omotica.
English: For more information about treatment with Xeristar, read the Package Leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Xeristar preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte s svojim zdravnikom ali farmacevtom.
English: The CHMP decided that Xeristar's benefits are greater than its risks and recommended that it be given marketing authorisation.
Slovenian: CHMP je zaključil, da so koristi zdravila Xeristar večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
English: What benefit has Xeristar shown during the studies?
Slovenian: Kakšne koristi je zdravilo Xeristar izkazalo med študijami?