FrancophonIA/ELRC3.0 huggingface dataset:
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER [See Annex I - To be completed nationally]
Slovenian: IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM [glejte Dodatek I - izpolni država članica]
English: Carnaxide, Portugal Tel-No.: 00351 21424 1284 Fax.No.
Slovenian: Tel-No.: 00351 21424 1284 Fax.No.
English: This medicinal product is authorised in the Member States of the EEA under following names:
Slovenian: To zdravilo je ima dovoljenje za promet v državah članicah ES pod naslednjimi imeni: [glejte Dodatek I - izpolni država članica]
English: What Ciprofloxacin Kabi looks like and contents of the pack Ciprofloxacin Kabi is a sterile, clear and colourless solution.
Slovenian: Ciprofloxacin Kabi je sterilna, bistra in brezbarvna raztopina.
English: reduction in red blood cells (anaemia), increase in white blood cells (leucocytosis), alteration of the prothrombin (coagulation factor) values, reduction in blood platelets (thrombocytopenia) with bruises and tendency to bleed, increase in blood platelets (thrombocytosis)
Slovenian: Redki zmanjšano število eritrocitov (anemija), povečano število levkocitov (levkocitoza), sprememba vrednosti protrombina (koagulacijskega faktorja), zmanjšano število trombocitov (trombocitopenija) s podplutbami in nagnjenostjo h krvavitvam, povečano število trombocitov (trombocitoza)
English: NL-5202 CJ´s Hertogenbosch Netherlands
Slovenian: NL-5202 CJ´s
English: Rare: myalgia (muscular pain), joint disorder (swollen joints).
Slovenian: Redki: mialgija (bolečine v mišicah), okvare sklepov (oteklost sklepov).
English: • complicated urinary tract infections
Slovenian: • zapletenih okužbah sečil
English: rash with red (moist) irregular spots (erythema (exsudativum) multiforme), tender bluish red bumps in the skin (erythema nodosum), severe condition with (high) fever, red spots on the skin, joint pains and/or eye infection (Stevens-Johnson syndrome), severe condition with fever and blisters on the skin/peeling of the skin (Lyell syndrome)
Slovenian: povečana občutljivost na svetlobo (fotosenzitivnost) Zelo redki: izpuščaj z rdečimi (vlažnimi) nepravilnimi madeži (eksudativni multiformni edem), občutljivi modrikasto rdeči vozli (nodozni eritem), hudo stanje z visoko vročino, rdečimi madeži na koži, bolečinami v sklepih in/ali očesno okužbo (Stevens-Johnsonov sindrom), hudo stanje s povečano telesno temperaturo in mehurji na koži/luščenjem kože (Lyellov sindrom)
English: administration 12% of ciprofloxacin is excreted in the urine and faeces in the form of metabolites.
Slovenian: Po peroralni uporabi se v obliki presnovkov v urinu in blatu izloči 19 % ciprofloksacina, po intravenski uporabi pa 12 %.
English: Very rare: pulmonary oedema in case of shock (anaphylactic; life-threatening), itching rash, serum sickness-like symptoms.
Slovenian: Zelo redki: pljučni edem v primeru šoka (anafilaktičen, smrtno nevaren), srbenje, izpuščaj, serumski bolezni podobni simptomi.
English: Ciprofloxacin Kabi 400 mg/200 ml solution for infusion: pack sizes: 1, 5, 10, 20, 30 or 40 bags.]
Slovenian: Ciprofloxacin Kabi 400 mg/200 ml raztopina za infundiranje: velikosti pakiranj: 1, 5, 10, 20, 30 ali 40 vrečk]
English: inflammation of the tendons (tendinitis, in particular of the Achilles tendon), partial or total tendon ruptures (in particular of the Achilles tendon), exacerbation of the symptoms of myasthenia gravis (a particular type of muscle weakness)
Slovenian: bolečina v mišicah (mialgija), okvare sklepov (otekanje sklepov) Zelo redki: vnetje kit (tendinitis, predvsem Ahilove kite), delno ali popolno raztrganje kite (predvsem Ahilove kite), poslabšanje simptomov miastenije gravis (posebne vrste mišične šibkosti)
English: Common: perverted sensation of taste, dizziness, headache, insomnia, agitation, confusion.
Slovenian: Občasni: motnje okušanja, omotica, glavobol, nespečnost, agitiranost, zmedenost.
English: PARTICULARS TO APPEAR ON THE OUTER PACKING Carton
Slovenian: PODATKI NA ZUNANJI OVOJNINI Vrečka
English: Therefore, patients receiving methotrexate therapy should be carefully monitored when concomitant ciprofloxacin therapy is indicated.
Slovenian: Iz tega razloga je potrebno bolnike, ki sočasno prejemajo metotreksat in ciprofloksacin, natančno nadzorovati.
English: Uncommon in more than 1 in 1,000 patients, but less than 1 in 100 patients
Slovenian: Občasni pri več kot 1 od 1.000 bolnikov, vendar manj kot 1 od 100 bolnikov
English: Disorders of the kidney and urinary tract Rare:
Slovenian: Bolezni ledvic in urinarnega trakta Redki:
English: Ciprofloxacin Kabi may also be administered in the treatment of acute lower respiratory tract infections caused by Pseudomonas aeruginosa in children and adolescents aged 5-17 years with cystic fibrosis.
Slovenian: Ciprofloxacin Kabi je mogoče uporabiti tudi za zdravljenje akutnih okužb spodnjih dihal, ki jih povzroča Pseudomonas aeruginosa pri otrocih in mladostnikih, starih od 5 do 17 let, s cistično fibrozo.
English: Rare: oedema (peripheral, angio, facial), allergic reaction, drug fever, anaphylactoid (anaphylactic) reaction.
Slovenian: Redki: edemi (periferni, angioedem, edem obraza), alergijska reakcija, zvišana telesna temperatura zaradi uporabe zdravila, anafilaktoidna (anafilaktična) reakcija.
English: Infections and infestations: Uncommon: moniliasis
Slovenian: Infekcijske in parazitske bolezni: Občasni: kandidoza
English: Ciprofloxacin Kabi and associated names (See Annex I) 100 mg/50 ml, solution for infusion Ciprofloxacin Kabi and associated names (See Annex I) 200 mg/100 ml, solution for infusion Ciprofloxacin Kabi and associated names (See Annex I) 400 mg/200 ml, solution for infusion
Slovenian: Ciprofloxacin Kabi in povezana imena (glejte Dodatek I) 100 mg/50 ml raztopina za infundiranje Ciprofloxacin Kabi in povezana imena (glejte Dodatek I) 200 mg/100 ml raztopina za infundiranje Ciprofloxacin Kabi in povezana imena (glejte Dodatek I) 400 mg/200 ml raztopina za infundiranje
English: You must not breast-feed your child during treatment with ciprofloxacin, due to the risk of malformation of joint cartilage and other harmful effects in the breast-fed infant.
Slovenian: Zaradi tveganja nepravilnega razvoja sklepnega hrustanca ali drugih škodljivih učinkov na dojenčka med zdravljenjem s ciprofloksacinom ne smete dojiti.
English: Hypersensitivity:
Slovenian: Preobčutljivost:
English: 2 mg/ml Solution for infusion Intravenous use 200 mg/100 ml, 400 mg/200 ml
Slovenian: 200 mg/100 ml, 400 mg/200 ml
English: Dosage as follows:
Slovenian: Ob upoštevanju naslednjega:
English: If creatinine clearance is ≤ 30 ml/minute/1.73 m2 or the serum creatinine concentration is
Slovenian: Če je očistek kreatinina ≤ 30 ml/min/1,73 m2 ali je koncentracija kreatinina v serumu ≥ 175 µmol/l, je največji dnevni intravenski odmerek 400 mg.
English: Sodium hydroxide for pH adjustment Water for injections
Slovenian: 6.1 Seznam pomožnih snovi natrijev klorid žveplova kislina natrijev hidroksid za uravnavanje pH voda za injekcije
English: Ciprofloxacin inhibits DNA-gyrase, resulting in inhibition of DNA synthesis.
Slovenian: Ciprofloksacin zavre DNAgirazo in s tem sintezo DNA.
English: You should consult your doctor if one of the precautions and warnings mentioned below are or were applicable to you in the past.
Slovenian: Bodite posebej pozorni pri uporabi zdravila Ciprofloxacin Kabi Posvetujte se z zdravnikom, če ste morali ali morate upoštevati katero od previdnostnih ukrepov ali opozoril, omenjenih spodaj
English: Excipient: sodium
Slovenian: Pomožna snov: natrij
English: Ciprofloxacin Kabi 200 mg/100 ml solution for infusion: pack sizes: 1, 5, 10, 20, 30 or 40 bags.
Slovenian: Ciprofloxacin Kabi 200 mg/100 ml raztopina za infundiranje: velikosti pakiranj: 1, 5, 10, 20, 30 ali 40 vrečk.
English: Uncommon: increase of the creatinine or urea level in the blood, abnormal liver function test results, bile pigment in the blood (bilirubinaemia) and increased blood level of a certain enzyme (alkaline phosphatase)
Slovenian: zvišana raven kreatinina ali sečnine v krvi, nenormalni izvidi preiskav delovanja jeter, pigment žolča v krvi (bilirubinemija) in zvišana koncentracija določenega encima (alkalne fosfataze)
English: increased blood level of amylase (enzyme that breaks down starch) and lipase (enzyme that breaks down fats).
Slovenian: Zelo redki: zvišana raven amilaze (encim, ki razgrajuje škrob) in lipaze (encim, ki razgrajuje maščobe) v krvi
English: Metabolism and nutrition disorders Rare:
Slovenian: Presnovne in prehranske motnje Redki:
English: severe and continuous diarrhoea, possibly with blood and mucus, due to a severe inflammation of the large intestine (pseudo membranous colitis), fungal infection in the mouth (oral moniliasis)
Slovenian: huda in trajajoča driska, lahko s krvjo ali sluzjo, zaradi hudega vnetja debelega črevesa (psevdomembranski kolitis), glivična okužba v ustih (oralna kandidoza) Zelo redki: glivična okužba prebavil (gastrointestinalna kandidoza), vnetje trebušne slinavke (pankreatitis)
English: Barcelona,SpainTel-No.: 0034 93 225 6580Fax.No.
Slovenian: Tel-No.: 0034 93 225 6580 Fax.No.
English: Hypersensitivity reactions and allergic reactions occurred in some cases after the first administration of ciprofloxacin.
Slovenian: V nekaterih primerih so se po prvi uporabi ciprofloksacina pojavile preobčutljivostne in alergijske reakcije.
English: As for other medicinal products in this group, ciprofloxacin has been reported to cause joint disorders in weight-bearing joints of immature animals.
Slovenian: Tako kot pri drugih zdravilih iz te skupine so tudi med uporabo ciprofloksacina pri nezrelih živalih opisane bolezni sklepov, ki nosijo telesno maso.
English: Since under-dosing is one of the 3 major factors in the development if antibiotic resistance to fluoroquinolones (4), this may be a case for using the higher dose of ciprofloxacin proposed by the applicant in the treatment of complicated UTIs.
Slovenian: Razlog za višje odmerke ciprofloksacina, ki jih vlagatelj predlaga pri zdravljenju zapletenih okužb sečil, je morda v dejstvu, da so prenizki odmerki eden izmed treh glavnih razlogov za razvoj antibiotične odpornosti na fluorokinolone (4).
English: E. coli ESBL producing
Slovenian: E. coli ESBL producing Klebsiella pneumoniae
English: Streptococcus pneumoniae
Slovenian: Streptoococus agalactiae Streptococcus pneumoniae S. pneumoniae PEN-R
English: anxieties, nightmares, severe depression, seeing things or hearing voices that do not exist (hallucinations)
Slovenian: tesnoba, nočne more, huda depresija, prividi ali prisluhi (halucinacije) Zelo redki: motena kontrola vedenja in dejanj (psihotične reakcije)
English: There are limited data on the use of ciprofloxacin during pregnancy.
Slovenian: O uporabi ciprofloksacina pri nosečnicah ni zadostnih podatkov.
English: Ciprofloxacin may cause an exacerbation of Myastenia gravis symptoms.
Slovenian: Ciprofloksacin lahko poslabša simptome miastenije gravis.
English: HOW TO STORE CIPROFLOXACIN KABI
Slovenian: SHRANJEVANJE ZDRAVILA CIPROFLOXACIN KABI
English: 50 ml
Slovenian: 100 mg/50 ml
English: After single and multiple i.v.
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA
English: It is contained in a clear flexible polyolefine bag with aluminium overpouch containing 200 ml solution.
Slovenian: Shranjen je v prozorni mehki poliolefinski vrečki z aluminijskim zunanjim ovojem in vsebuje 200 ml raztopine.
English: Local reactions have been reported after intravenous administration of ciprofloxacin.
Slovenian: Po intravenski uporabi ciprofloksacina so opisane lokalne reakcije.
English: twice daily for the treatment of complicated urinary tract infections was identified.
Slovenian: Ne obstaja nobena raziskava, pri kateri bi za zdravljenje zapletenih okužb sečil uporabljali 100 mg intravenozni odmerek dvakrat dnevno.
English: • liver impairment in the past.
Slovenian: • Anamneza okvare jeter.
English: Breathing and chest disorders Rare:
Slovenian: Bolezni dihanja in prsnega koša Redki:
English: It is contained in a clear flexible polyolefine bag with aluminium overpouch containing 50 ml solution.
Slovenian: Shranjen je v prozorni mehki poliolefinski vrečki z aluminijskim zunanjim ovojem in vsebuje 50 ml raztopine.
English: HOW TO USE CIPROFLOXACIN KABI
Slovenian: KAKO UPORABLJATI ZDRAVILO CIPROFLOXACIN KABI
English: It is contained in a clear flexible polyolefine bag with aluminium overpouch containing 100 ml solution.
Slovenian: Shranjen je v prozorni mehki poliolefinski vrečki z aluminijskim zunanjim ovojem in vsebuje 100 ml raztopine.
English: Uncommon: vomiting, dyspepsia, flatulence, anorexia, abdominal pain.
Slovenian: Občasni: bruhanje, dispepsija, flatulenca, anoreksija, abdominalna bolečina Redki: psevdomembranski kolitis, kandidoza (oralna).
English: MARKETING AUTHORISATION HOLDER [See Annex I - To be completed nationally]
Slovenian: IMETNIK DOVOLJENJA ZA PROMET [glejte Dodatek I - izpolni država članica]
English: Musculoskeletal, conective tissue and bone disorders:
Slovenian: Bolezni skeletnih mišic, kit in kosti Občasni:
English: Impaired renal and hepatic function:
Slovenian: Okvarjeno delovanje ledvic in jeter:
English: The applicant/MAH did not submit any clinical data to address the questions related to the risk/benefit of the proposed dose in UTIs and the maximum adult daily dose, as this application is a so called ″generic″ application (reference product/originator Ciproxin from Bayer).
Slovenian: Ker gre za t.i. "generično" vlogo (referenčno zdravilo in originator je Ciproxin podjetja Bayer), vlagatelj/imetnik dovoljenja za promet ni predložil kliničnih podatkov za reševanje vprašanj, povezanih s tveganji in koristnimi učinki pri predlaganem odmerku za zdravljenje okužb sečil in največjim dnevnim odmerkom pri odraslih.
English: Therefore, patients taking these substances concomitantly with ciprofloxacin should be monitored closely for clinical signs of overdose.
Slovenian: Bolnike, ki hkrati s ciprofloksacinom jemljejo takšna zdravila, je zato treba natančno nadzirati glede kliničnih znakov prevelikega odmerjanja; potrebna utegne biti določitev koncentracije v serumu, še zlasti za teofilin.
English: 200 ml
Slovenian: 400 mg/200 ml
English: Lactation:
Slovenian: Okrajšave:
English: Uncommon: pruritis, papillo-macular rash, urticaria.
Slovenian: Občasni: srbenje, papilomakularen izpuščaj, urtikarija.
English: Marketing Authorisation Holder: [See Annex I - To be completed nationally]
Slovenian: Imetnik dovoljenja za promet: [glejte Dodatek I -izpolni država članica]
English: smell disorder (parosmia), loss of smell (anosmia, the smell usually returns after termination of treatment), convulsions (grand mal convulsion), abnormal (unstable) gait, increased pressure in the head (intracranial hypertension)
Slovenian: zmanjšana sposobnost okušanja, spremenjeni občutki na koži (parestezija), tresenje (tremor), krči/konvulzije (napad krčev), hud glavobol (migrena) Zelo redki: motnja voha (parozmija), nezmožnost vohanja (anozmija, voh se navadno povrne po prekinitvi zdravljenja), epileptični napadi (generalizirani), nenormalna (nestabilna) hoja, povečan tlak v glavi (intrakranialna hipertenzija)
English: Disorders of the liver and gall-bladder Rare:
Slovenian: Bolezni jeter in žolčnika Redki:
English: nausea, diarrhoea
Slovenian: občutek siljenja na bruhanje, driska
English: As ciprofloxacin is 70-85% bioavailable, the oral doses of 250-500mg bid.
Slovenian: Ker znaša biološka razpoložljivost ciprofloksacina 70 - 85 %, je višina peroralnih odmerkov od 250500 mg dvakrat dnevno, ki so jih uporabljali v večini objavljenih raziskav, enakovredna intravenoznemu odmerku 200-400 mg dvakrat dnevno.
English: Each bag of 50 ml contains 100 mg of ciprofloxacin.
Slovenian: Vsaka vrečka s 50 ml vsebuje 100 mg ciprofloksacina.
English: • The active substance is ciprofloxacin (as hydrogen sulphate).
Slovenian: Kaj vsebuje zdravilo Ciprofloxacin Kabi • Zdravilna učinkovina je ciprofloksacin (v obliki ciprofloksacinijevega hidrogensulfata).
English: Uncommon: arthralgia (joint pain).
Slovenian: Občasni: artralgija (bolečine v sklepih).
English: Acinetobacter baumannii
Slovenian: Acinetobacter baumannii Campylobacter spp.
English: Blood and the lymphatic system disorders:
Slovenian: Bolezni krvi in limfatičnega sistema:
English: Each bag with 200 ml contains 400 mg ciprofloxacin.]
Slovenian: Vsaka vrečka z 200 ml vsebuje 400 mg ciprofloksacina.]
English: PHARMACEUTICAL FORM AND CONTENTS Solution for infusion
Slovenian: FARMACEVTSKA OBLIKA IN VSEBINA Rztopina za infundiranje 50 ml
English: 1, 5, 10, 20, 30, 40 x 200 ml
Slovenian: FARMACEVTSKA OBLIKA IN VSEBINA Rztopina za infundiranje 1, 5, 10, 20, 30, 40 x 200 ml
English: shortness of breath (dyspnoea), swelling of the voice box (larynx) with difficulties in breathing (larynx oedema)
Slovenian: kratka sapa (dispneja), otekanje grla s težavami pri dihanju (edem grla) Bolezni želodca in črevesja
English: Enterobacter aerogenes
Slovenian: Enterobacter aerogenes Enterobacter spp.
English: clinical data and discuss the risk/benefit of the maximum adult daily dose, i.e. whether it should be 400 mg bid or 400 mg three times daily.
Slovenian: Klinične podatke in razpravo o tveganjih/koristnih učinkih največjega dnevnega odmerka pri odraslih, t.j.
English: Uncommon: vomiting, digestive disorders, gassiness (flatulence), loss of appetite, abdominal pain Rare:
Slovenian: bruhanje, prebavne motnje, vetrovi (flatulenca), izguba apetita, bolečina v trebuhu
English: intravenous dose.
Slovenian: Za intravensko uporabo
English: General disorders and administration site conditions Uncommon: general sensation of weakness, fatigue (asthenia), irritation or pain at the injection site Rare:
Slovenian: splošni občutek šibkosti, utrujenost (astenija), draženje ali bolečina na mestu injiciranja
English: Uncommon: increase in eosinophilic cells (eosinophilia), reduction in white blood cells (leucopenia)
Slovenian: povečano število eozinofilcev (eozinofilija), zmanjšano število levkocitov (levkopenija), kar povzroča večjo dovzetnost za okužbe
English: 1, 5, 10, 20, 30, 40 x 100 ml
Slovenian: FARMACEVTSKA OBLIKA IN VSEBINA Rztopina za infundiranje 1, 5, 10, 20, 30, 40 x 100 ml
English: Common: nausea, diarrhoea.
Slovenian: Bolezni prebavil: Pogosti: navzea, driska.
English: GROUNDS FOR AMENDMENT OF THE SUMMARY(IES) OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLET
Slovenian: PODLAGA ZA DOPOLNILO POVZETKA GLAVNIH ZNAČILNOSTI ZDRAVILA, OZNAČEVANJA IN NAVODIL ZA UPORABO
English: 1, 5, 10, 20, 30, 40 x 50 ml
Slovenian: FARMACEVTSKA OBLIKA IN VSEBINA Rztopina za infundiranje 1, 5, 10, 20, 30, 40 x 50 ml
English: Each bag with 100 ml contains 200 mg ciprofloxacin.
Slovenian: Vsaka vrečka s 100 ml vsebuje 200 mg ciprofloksacina.
English: Ciprofloxacin Kabi and associated names (See Annex I) 100 mg/50 ml solution for infusion [See Annex I - To be completed nationally]
Slovenian: Ciprofloxacin Kabi in povezana imena (glejte Dodatek I) 100 mg/50 ml raztopina za infundiranje [glejte Dodatek I -izpolni država članica]
English: liver inflammation (hepatitis), destruction of liver tissue (liver cell necrosis, very rarely resulting in life-threatening liver failure)
Slovenian: porumenelost kože ali beločnic (zlatenica), zlatenica zaradi stanja, pri katerem žolč ne more normalno prehajati iz jeter (holestatski ikterus) Zelo redki: vnetje jeter (hepatitis), uničenje jetrnega tkiva (nekroza jetrnih celic, ki zelo redko povzroči življenjsko nevarno jetrno odpoved)
English: Respiratory, thoracic and mediastinal disorders:
Slovenian: Bolezni jeter, žolčnika in žolčevodov:
English: Each bag of 200 ml contains 400 mg of ciprofloxacin.
Slovenian: Vsaka vrečka z 200 ml vsebuje 400 mg ciprofloksacina.
English: Proteus vulgaris Salmonella spp.
Slovenian: Salmonella spp.
English: Ciprofloxacin Kabi and associated names (See Annex I) 400 mg/200 ml solution for infusion [See Annex I - To be completed nationally]
Slovenian: Ciprofloxacin Kabi in povezana imena (glejte Dodatek I) 400 mg/200 ml raztopina za infundiranje [glejte Dodatek I -izpolni država članica]
English: What Ciprofloxacin Kabi is and what it is used for Before you use Ciprofloxacin Kabi How to use Ciprofloxacin Kabi Possible side effects
Slovenian: KAJ MORATE VEDETI, PREDEN BOSTE UPORABILI ZDRAVILO CIPROFLOXACIN KABI
English: increased heart rate (tachycardia)
Slovenian: bolečina v sklepih (artralgija)
English: [To be completed nationally]
Slovenian: [Izpolni država članica]----------------------------------------------------------------------------------------------
English: Ciprofloxacin Kabi and associated names (See Annex I) 200 mg/100 ml solution for infusion [See Annex I - To be completed nationally]
Slovenian: Ciprofloxacin Kabi in povezana imena (glejte Dodatek I) 200 mg/100 ml raztopina za infundiranje [glejte Dodatek I -izpolni država članica]
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml of solution for infusion contains 2 mg ciprofloxacin (as hydrogen sulphate) [Each bag with 50 ml contains 100 mg ciprofloxacin.
Slovenian: NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN 1 ml raztopine za infundiranje vsebuje 2 mg ciprofloksacina (v obliki ciprofloksacinijevega hidrogensulfata).
English: Ciprofloxacin and other fluoroquinolones may cause photosensibility.
Slovenian: Ciprofloksacin in drugi fluorokinoloni lahko povzročijo fotosenzibilnost, zato naj se bolniki med zdravljenjem s ciprofloksacinom izogibajo dolgotrajni izpostavljenosti sončni svetlobi ali UV žarkom.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each ml of solution for infusion contains 2 mg ciprofloxacin (as hydrogen sulphate) Each bag with 50 ml contains 100 mg ciprofloxacin.
Slovenian: 1 ml raztopine za infundiranje vsebuje 2 mg ciprofloksacina (v obliki ciprofloksacinijevega hidrogensulfata).
English: Very rare in less than 1 in 10,000 patients, including isolated reports
Slovenian: Zelo redki pri več kot 1 od 10.000 bolnikov, vključujoč posamezne primere Infekcijske in parazitske bolezni Občasni: glivična okužba (kandidoza)
English: This was recorded in two questionnaires completed at home.
Slovenian: To so ugotavljali s pomočjo dveh doma izpolnjenih vprašalnikov.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Vivanza on 4 March 2003.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Vivanza, veljavno po vsej Evropski uniji, izdala 4. marca 2003.
English: The main measure of effectiveness was the ability to get and maintain an erection.
Slovenian: Glavno merilo učinkovitosti je bila sposobnost doseči in obdržati erekcijo.
English: What measures are being taken to ensure the safe and effective use of Vivanza?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Vivanza?
English: • patients who have hypotension (low blood pressure);
Slovenian: • bolniki s hipotenzijo (nizkim krvnim tlakom);
English: The full EPAR for Vivanza can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Slovenian: Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Vivanza je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: • patients who have had a stroke or a heart attack within the last six months;
Slovenian: • bolniki, ki so v zadnjih šestih mesecih doživeli možgansko kap ali srčni napad;
English: Because Vivanza has not been studied in the following groups of patients, they must not use the medicine:
Slovenian: Ker zdravilo Vivanza pri naslednjih skupinah bolnikov ni bilo raziskano, ga ne smejo jemati:
English: It is available as film-coated tablets (5, 10 and 20 mg) and as orodispersible tablets (10 mg).
Slovenian: Na voljo je v obliki filmsko obloženih (5, 10 in 20 mg) in orodisperzibilnih tablet (10 mg).
English: A risk management plan has been developed to ensure that Vivanza is used as safely as possible.
Slovenian: Za zagotovitev čim varnejše uporabe zdravila Vivanza je bil pripravljen načrt obvladovanja tveganj.
English: This is a summary of the European public assessment report (EPAR) for Vivanza.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Vivanza.