FrancophonIA/ELRC3.0 huggingface dataset:
English: ≤ 75 years old Dose (Cycle 1-8: Days 1, 2, 4, 5, 8, 9, 11, 12 of a 21-day cycle Cycle ≥ 9: Days 1, 2, 8, 9 of a 21-day cycle)
Slovenian: ≤ 75 let stari Odmerek (cikel 1-8: 1., 2., 4., 5., 8., 9., 11., 12. dan 21-dnevnega cikla Cikel ≥ 9: 1., 2., 8., 9. dan 21-dnevnega cikla)
English: • Inflammation of the liver (hepatitis) which can cause itchy skin, yellowing of the skin and the whites of the eyes (jaundice), pale coloured stools, dark coloured urine and abdominal pain.
Slovenian: • vnetje jeter (hepatitis), ki lahko povzroči srbenje kože, rumeno obarvanje kože in beločnic oči
English: Imnovid 1 mg hard capsules Each hard capsule contains 1 mg of pomalidomide.
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA Imnovid 1 mg trde kapsule Ena kapsula vsebuje 1 mg pomalidomida.
English: Dizziness and confusional state have been reported with pomalidomide.
Slovenian: Pri pomalidomidu so poročali o omotičnosti in zmedenosti.
English: Mean exposure to pomalidomide increased by 58% with a 90% confidence interval [13% to 119%] in moderately hepatically impaired patients compared to healthy subjects.
Slovenian: Pri bolnikih z zmerno okvaro jeter se je v primerjavi z zdravimi osebami srednja izpostavljenost pomalidomidu zvečala za 58 % z 90 % intervalom zaupanja [13 % do 119 %].
English: If strong inhibitors of CYP1A2 (e.g. ciprofloxacin, enoxacin and fluvoxamine) are co-administered with pomalidomide, reduce the dose of pomalidomide by 50%.
Slovenian: Pri sočasnem dajanju močnih zaviralcev encima CYP1A2 (npr. ciprofloksacin, enoksacin in fluvoksamin) s pomalidomidom zmanjšajte odmerek pomalidomida za 50 %.
English: Second primary malignancies, such as non-melanoma skin cancer, have been reported in patients receiving pomalidomide (see section 4.8).
Slovenian: Pri bolnikih, ki so jemali pomalidomid, so poročali o drugih primarnih malignostih, na primer o nemelanomskem kožnem raku (glejte poglavje 4.8).
English: Cardiac failure Atrial fibrillation Myocardial infarction
Slovenian: Srčne bolezni pogosti popuščanje srca atrijska fibrilacija miokardni infarkt pogosti popuščanje srca atrijska fibrilacija občasni miokardni infarkt
English: Resume pomalidomide treatment at one dose level lower than the previous dose.
Slovenian: Nadaljujte zdravljenje s pomalidomidom z odmerkom, za eno raven manjšim od predhodnega odmerka.
English: Data cutoff: 07 Sep 2012
Slovenian: Datum zaključka zbiranja podatkov: 7. sept. 2012
English: No adjustment of the starting dose of pomalidomide is required for patients with hepatic impairment as defined by the Child-Pugh criteria.
Slovenian: Pri bolnikih z okvaro jeter, opredeljeno po Child-Pughovih kriterijih, ni potrebna prilagoditev začetnega odmerka pomalidomida.
English: • The recommended starting dose of Imnovid is 4 mg per day.
Slovenian: • Priporočeni začetni odmerek zdravila Imnovid je 4 mg na dan.
English: Reactivation of hepatitis B has been reported rarely in patients receiving pomalidomide in combination with dexamethasone who have previously been infected with the hepatitis B virus (HBV).
Slovenian: Pri bolnikih, ki so prejemali pomalidomid v kombinaciji z deksametazonom in ki so bili prej okuženi z virusom hepatitisa B (HBV), so redko poročali o reaktivaciji hepatitisa B. Nekateri od teh primerov so napredovali v akutno odpoved jeter, zaradi katere so pomalidomid ukinili.
English: Depressed level of consciousness Peripheral sensory neuropathy Dizziness
Slovenian: Bolezni živčevja pogosti zmanjšana stopnja zavesti periferna senzorična nevropatija omotica tremor pogosti zmanjšana stopnja zavesti občasni periferna senzorična nevropatija omotica tremor
English: Hard capsule Imnovid 1 mg hard capsules
Slovenian: trda kapsula Imnovid 1 mg trde kapsule
English: Permanently discontinue treatment (see section
Slovenian: Trajno prekinite zdravljenje (glejte poglavje 4.4).
English: Talk to your doctor, pharmacist or nurse before taking Imnovid if:
Slovenian: Pred začetkom jemanja zdravila Imnovid se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro, če:
English: Mean exposure to pomalidomide increased by 72% with a 90% confidence interval [24% to 138%] in severely hepatically impaired patients compared to healthy subjects.
Slovenian: Pri bolnikih s hudo okvaro jeter se je v primerjavi z zdravimi osebami srednja izpostavljenost pomalidomidu zvečala za 72 % z 90 % intervalom zaupanja [24 % do 138 %].
English: Patients should not donate blood, semen or sperm during treatment (including during dose interruptions) and for 7 days following discontinuation of pomalidomide.
Slovenian: Bolniki med zdravljenjem (vključno s prekinitvami odmerkov) s pomalidomidom ali 7 dni po prekinitvi zdravljenja ne smejo darovati krvi, semena ali sperme.
English: Progression Free Survival Time by IRAC Review Based on IMWG Criteria (Stratified Log Rank Test) (ITT Population)
Slovenian: Čas preživetja brez napredovanja na podlagi IRAC-ovega pregleda odzivov na podlagi kriterijev IMWG (stratificirani test log-rank) (populacija ITT)
English: • Clouding of your eye (cataract).
Slovenian: • zamotnitev očesne leče (katarakta),
English: Add H2 blocker or equivalent and resume at one dose level lower than previous dose.
Slovenian: Dodajte antagonist histaminskih receptorjev (H2) in nadaljujte zdravljenje z odmerkom, za eno raven manjšim od predhodnega odmerka.
English: Grade 3−4 Adverse Reactions /Frequency
Slovenian: - 4. stopnje /pogostnost
English: • Post-authorisation efficacy study (PAES) MM-007: In order to further investigate the efficacy of pomalidomide in combination with bortezomib and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least one prior treatment regimen including lenalidomide, the MAH should submit the final analysis of OS from the phase 3, randomized, open label study MM-007.
Slovenian: • Študija učinkovitosti po pridobitvi dovoljenja za promet (PAES) MM007: da se natančneje razišče učinkovitost pomalidomida v kombinaciji z bortezomibom in deksametazonom pri zdravljenju odraslih bolnikov z diseminiranim plazmocitomom, ki so prejeli vsaj eno predhodno shemo zdravljenja in je vključevala lenalidomid.
English: When Imnovid is used with dexamethasone, in people who have had at least two other treatments, it can stop multiple myeloma getting worse:
Slovenian: Koristni učinki uporabe zdravila Imnovid skupaj z deksametazonom Ko se zdravilo Imnovid uporablja skupaj z deksametazonom pri ljudeh, ki so že imeli vsaj dve drugi zdravljenji, lahko ustavi poslabšanja diseminiranega plazmocitoma:
English: What Imnovid is and what it is used for What you need to know before you take Imnovid How to take Imnovid
Slovenian: Kaj je zdravilo Imnovid in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Imnovid Kako jemati zdravilo Imnovid Možni neželeni učinki
English: • The recommended dose of Imnovid is 4 mg per day.
Slovenian: • Priporočeni odmerek zdravila Imnovid je 4 mg enkrat na dan.
English: Common Basal cell carcinoma
Slovenian: pogosti bazalnocelični karcinom
English: IMN: Imnovid; DEX: Dexamethasone
Slovenian: • IMN: Imnovid; deks: deksametazon Ime zdravila Dan IMN deks
English: • Abdominal pain, swollen abdomen.
Slovenian: • bolečine v trebuhu, napihnjenost trebuha,
English: No dose adjustment of pomalidomide is required for patients with renal impairment.
Slovenian: Pri bolnikih z okvaro ledvic ni potrebno prilagajanje odmerka pomalidomida.
English: HD - DEX POM+LD - DEX
Slovenian: VO-deks POM+NO-deks
English: • Stroke.
Slovenian: • padci,
English: Hypokalaemia Hyperglycaemia Hypomagnaesaemia Hypocalcaemia Hypophosphataemia Hyperkalaemia Hypercalcaemia
Slovenian: Presnovne in prehranske motnje zelo pogosti hipokaliemija hiperglikemija pogosti hipomagneziemija hipokalciemija hipofosfatemija hiperkaliemija hiperkalciemija pogosti hipokaliemija hiperglikemija hipomagneziemija hipokalciemija hipofosfatemija hiperkaliemija hiperkalciemija
English: Dose Level -2
Slovenian: Raven odmerka -2
English: • Low blood levels of sodium, which may cause tiredness and confusion, muscle twitching, fits
Slovenian: • nizke ravni natrija v krvi, ki lahko povzročijo utrujenost in zmedenost, trzanje mišic, konvulzije (epileptične napade) ali komo,
English: Imnovid 1 mg hard capsule:
Slovenian: Imnovid 1 mg trda kapsula:
English: Instructions for dose modification for dexamethasone related adverse reactions are outlined in Table 4.
Slovenian: Prilagajanje ali prekinitev odmerjanja deksametazona Navodila za prilagajanje odmerka zaradi neželenih učinkov, povezanih z deksametazonom, so opisana v preglednici 4.
English: • Tubal sterilisation
Slovenian: • sterilizacija jajcevodov,
English: For the HD-Dex arm, dexamethasone (40 mg) was administered once per day on days 1 through 4, 9 through 12, and 17 through 20 of a 28-day cycle.
Slovenian: V skupini VO-deks so deksametazon (40 mg) dajali enkrat na dan od 1. do vključno 4. dne, od 9. do
English: Neutrophil count decreased White blood cell count decreased Platelet count decreased Alanine aminotransferase increased
Slovenian: Preiskave pogosti zvišana alanin aminotransferaza zmanjšana telesna masa pogosti zmanjšana telesna masa občasni zvišana alanin aminotransferaza
English: Imnovid 4 mg hard capsules: Dark blue opaque cap and blue opaque body, with “POML 4 mg” written on them.
Slovenian: Imnovid 4 mg trde kapsule: temnomoder neprozoren pokrovček in modro neprozorno telo z napisom "POML 4 mg" na njih.
English: • That the patient should not donate blood during therapy (including during dose interruptions) and for
Slovenian: • opozorilo, da bolnik ne sme darovati krvi med zdravljenjem (vključno s prekinitvami odmerjanja) in še 7 dni po končanem zdravljenju s pomalidomidom;
English: The most commonly reported Grade 3 or 4 adverse reactions were blood and lymphatic system disorders including neutropenia (41.7%), thrombocytopenia (27.3%) and anaemia (14.0%).
Slovenian: Neželeni učinke 3. ali 4. stopnje, o katerih so najpogosteje poročali, so bile bolezni krvi in limfatičnega sistema, vključno z nevtropenijo (41,7 %), trombocitopenijo
English: Titanium dioxide (E171) Indigotine (E132) Yellow iron oxide (E172) Erythrosin (E127) White ink
Slovenian: Imnovid 2 mg trde kapsule želatina titanov dioksid (E171) indigotin (E132) rumeni železov oksid (E172) eritrozin (E127) belo črnilo
English: Injury, poisoning and procedural complications
Slovenian: Poškodbe in zastrupitve in zapleti pri posegih pogosti padec občasni padec
English: • Lack of energy.
Slovenian: • izguba energije, • nespečnost,
English: Imnovid with dexamethasone only
Slovenian: Zdravilo Imnovid samo z deksametazonom
English: Pom+Btz+LD-Dex (N = 281)
Slovenian: Povzetek celotnih podatkov učinkovitosti Pom+Btz+NO-deks (N = 281)
English: • Rashes.
Slovenian: • vsadek,
English: Titanium dioxide (E171) Indigotine (E132) Brilliant blue FCF (E133) White ink
Slovenian: Imnovid 4 mg trde kapsule želatina titanov dioksid (E171) indigotin (E132) brilijantno modro FCF (E133) belo črnilo
English: A total of 559 patients were enrolled and randomised in the study: 281 in the Pom+Btz+LD-Dex arm and 278 in the Btz+LD-Dex arm. 54% of patients were male with median age for the overall population of 68 years (min, max: 27, 89 years).
Slovenian: V študijo je bilo vključenih in randomiziranih skupaj 559 bolnikov: 281 v skupino Pom+Btz+NO-deks in 278 v skupino Btz+NO-deks.
English: Imnovid 1 mg hard capsules pomalidomide
Slovenian: Imnovid 1 mg trde kapsule pomalidomid
English: Deep vein thrombosis Hypotension Hypertension
Slovenian: Žilne bolezni pogosti globoka venska tromboza hipotenzija hipertenzija pogosti hipotenzija hipertenzija občasni globoka venska tromboza
English: Hepatobiliary disorders Uncommon Hepatitis
Slovenian: Infekcijske in parazitske bolezni neznana pogostnost reaktivacija hepatitisa B
English: • Hives (urticaria).
Slovenian: • zasoplost (dispnea),
English: Dark blue opaque cap and yellow opaque body, imprinted “POML” in white ink and “1 mg” in black ink, size 4 gelatin hard capsule.
Slovenian: Temno moder neprozoren pokrovček in rumeno neprozorno telo z belim natisom "POML" in črnim natisom "1 mg", velikost 4, želatinasta trda kapsula.
English: • The capsule shell contains: gelatin, titanium dioxide (E171), indigotine (E132) and yellow iron oxide (E172) and white and black ink.
Slovenian: • Ovojnica kapsule vsebuje: želatino, titanov dioksid (E171), indigotin (E132), rumeni železov oksid (E172) ter belo in črno črnilo;
English: • some antifungals such as ketaconazole
Slovenian: • nekatere antimikotike, kot je ketokonazol,
English: Mannitol (E421) Starch, pregelatinised Sodium stearyl fumarate
Slovenian: FARMACEVTSKI PODATKI 6.1 Seznam pomožnih snovi Vsebina kapsule manitol (E421) škrob, predgelirani natrijev stearilfumarat
English: • Each capsule contains 1 mg of pomalidomide.
Slovenian: • Ena kapsula vsebuje 1 mg pomalidomida.
English: Pomalidomide crossed the placenta and was detected in foetal blood following administration to pregnant rabbits, see section 5.3.
Slovenian: Pomalidomid prehaja skozi posteljico in je bil zaznan v krvi zarodkov po dajanju brejim kunkam.
English: Imnovid 2 mg hard capsules: Dark blue opaque cap and orange opaque body, with “POML 2 mg” written on them.
Slovenian: Imnovid 2 mg trde kapsule: temnomoder neprozoren pokrovček in oranžno neprozorno telo z napisom "POML 2 mg" na njih.
English: Imnovid 1 mg hard capsules Imnovid 2 mg hard capsules Imnovid 3 mg hard capsules Imnovid 4 mg hard capsules pomalidomide
Slovenian: Imnovid 1 mg trde kapsule Imnovid 2 mg trde kapsule Imnovid 3 mg trde kapsule Imnovid 4 mg trde kapsule
English: Imnovid 3 mg hard capsules: Dark blue opaque cap and green opaque body, with “POML 3 mg” written on them.
Slovenian: Imnovid 3 mg trde kapsule: temnomoder neprozoren pokrovček in zeleno neprozorno telo z napisom "POML 3 mg" na njih.
English: • Constipation, diarrhoea or nausea.
Slovenian: • zaprtje, driska ali slabost s siljenjem na bruhanje,
English: Imnovid 2 mg hard capsule:
Slovenian: Imnovid 2 mg trda kapsula:
English: • Adverse event reporting forms
Slovenian: • obrazce za poročanje o neželenih učinkih.
English: Hepatic disorders
Slovenian: Hematološki dogodki
English: • The capsule shell contains: gelatin, titanium dioxide (E171), indigotine (E132), brilliant blue FCF
Slovenian: • Ovojnica kapsule vsebuje: želatino, titanov dioksid (E171), indigotin (E132), briljantno modro FCF (E133) in belo črnilo.
English: Imnovid 4 mg hard capsules
Slovenian: Imnovid 4 mg trde kapsule
English: • Each capsule contains 3 mg of pomalidomide.
Slovenian: • Ena kapsula vsebuje 3 mg pomalidomida.
English: Upper respiratory tract infection Respiratory tract infection Lower respiratory tract infection Lung infection
Slovenian: Bolezni dihal, prsnega koša in mediastinalnega prostora pogosti epistaksa intersticijska pljučna bolezen občasni epistaksa intersticijska pljučna bolezen
English: Common Rash
Slovenian: Raven odmerka
English: Respiratory, thoracic and mediastinal disorders
Slovenian: Bolezni jeter, žolčnika in žolčevodov občasni hepatitis
English: Each hard capsule contains 1 mg of pomalidomide.
Slovenian: Ena trda kapsula vsebuje 1 mg pomalidomida.
English: • Each capsule contains 2 mg of pomalidomide.
Slovenian: • Ena kapsula vsebuje 2 mg pomalidomida.
English: Imnovid 2 mg hard capsules pomalidomide
Slovenian: Imnovid 2 mg trde kapsule pomalidomid
English: Unused medicinal product should be returned to the pharmacist at the end of treatment.
Slovenian: Ob koncu zdravljenja morate neuporabljeno zdravilo vrniti farmacevtu.
English: Imnovid 3 mg hard capsule:
Slovenian: Imnovid 3 mg trda kapsula:
English: Each hard capsule contains 4 mg of pomalidomide.
Slovenian: Ena trda kapsula vsebuje 4 mg pomalidomida.
English: Titanium dioxide (E171) Indigotine (E132) Yellow iron oxide (E172) White and black ink
Slovenian: Imnovid 1 mg trde kapsule želatina titanov dioksid (E171) indigotin (E132) rumeni železov oksid (E172) belo in črno črnilo
English: Imnovid 2 mg hard capsules
Slovenian: Imnovid 2 mg trde kapsule
English: Peripheral sensory neuropathy Peripheral sensorimotor neuropathy
Slovenian: Bolezni živčevja zelo pogosti periferna senzorična nevropatija omotica tremor pogosti sinkopa periferna senzorimotorična nevropatija parestezije disgevzija pogosti sinkopa periferna senzorična nevropatija periferna senzorimotorična nevropatija občasni omotica tremor
English: Resume at one dose level lower than previous dose.
Slovenian: Nadaljujte zdravljenje z odmerkom, za eno raven manjšim od predhodnega odmerka.
English: Decrease by one dose level if symptoms persist.
Slovenian: Če simptomi vztrajajo, zmanjšajte odmerek za eno raven.
English: Each hard capsule contains 3 mg of pomalidomide.
Slovenian: Ena trda kapsula vsebuje 3 mg pomalidomida.
English: Each hard capsule contains 2 mg of pomalidomide.
Slovenian: Ena trda kapsula vsebuje 2 mg pomalidomida.
English: Titanium dioxide (E171) Indigotine (E132) Yellow iron oxide (E172) White ink
Slovenian: Imnovid 3 mg trde kapsule želatina titanov dioksid (E171) indigotin (E132) rumeni železov oksid (E172) belo črnilo
English: Angioedema and severe cutaneous reactions including SJS, TEN and DRESS has been reported with the use of pomalidomide.
Slovenian: Pri uporabi pomalidomida so poročali o angioedemu in hudih dermatoloških reakcijah, vključno s SJS, TEN in DRESS.
English: Acute kidney injury Chronic kidney injury Urinary retention
Slovenian: Bolezni sečil pogosti akutna okvara ledvic kronična okvara ledvic zastajanje urina pogosti akutna okvara ledvic kronična okvara ledvic zastajanje urina
English: Dark blue opaque cap and orange opaque body, imprinted “POML 2 mg” in white ink, size 2 gelatin hard capsule.
Slovenian: Temno moder neprozoren pokrovček in oranžno neprozorno telo z belim natisom "POML 2 mg", velikost 2, želatinasta trda kapsula.
English: Imnovid 3 mg hard capsules
Slovenian: Imnovid 3 mg trde kapsule
English: What Imnovid looks like and contents of the pack Imnovid 1 mg hard capsules: Dark blue opaque cap and yellow opaque body, with “POML 1 mg” written on them.
Slovenian: Imnovid 1 mg trde kapsule: temnomoder neprozoren pokrovček in rumeno neprozorno telo z napisom "POML 1 mg" na njih.
English: Dark blue opaque cap and green opaque body, imprinted “POML 3 mg” in white ink, size 2 gelatin hard capsule.
Slovenian: Temno moder neprozoren pokrovček in zeleno neprozorno telo z belim natisom "POML 3 mg", velikost 2, želatinasta trda kapsula.
English: Dark blue opaque cap and blue opaque body, imprinted “POML 4 mg” in white ink, size 2 gelatin hard capsule.
Slovenian: Temno moder neprozoren pokrovček in modro neprozorno telo z belim natisom "POML 4 mg", velikost 2, želatinasta trda kapsula.
English: NE Two sided 95% CIb [48.1, NE] Hazard Ratio (Pom+LD-Dex:HD-Dex) [Two sided 95% CIc] Log-Rank Test Two sided P-Value d
Slovenian: Razmerje tveganja (POM + NO-deks : VO-deks) [2 stranski 95 % IZc]
English: Imnovid 3 mg hard capsules pomalidomide
Slovenian: Imnovid 3 mg trde kapsule pomalidomid
English: If pomalidomide makes contact with the mucous membranes, they should be thoroughly flushed with water.
Slovenian: V primeru stika pomalidomida s sluznico jo morate temeljito sprati z obilico vode.
English: Blood and lymphatic system disorders
Slovenian: Bolezni krvi in limfatičnega sistema pogosti pancitopenija pogosti pancitopenija
English: Imnovid 4 mg hard capsules pomalidomide
Slovenian: Imnovid 4 mg trde kapsule pomalidomid
English: Very Common Muscular weakness Back pain
Slovenian: Bolezni mišičnoskeletnega sistema in vezivnega tkiva zelo pogosti mišična šibkost bolečine v hrbtu pogosti bolečine v kosteh mišični spazmi pogosti mišična šibkost bolečine v hrbtu občasni bolečine v kosteh
English: Common Diarrhoea Vomiting Abdominal pain Constipation
Slovenian: Motnje reprodukcije in dojk pogosti bolečina v medenici pogosti bolečina v medenici
English: muscle aches, palpitations, tingling or numbness, dyspnoea, mood changes.
Slovenian: • znižana raven kalija v krvi (hipokaliemija), ki lahko povzroči šibkost, mišične krče, bolečine v mišicah, palpitacije, mravljinčenje in odrevenelost, dispneo, spremembe razpoloženja,
English: Very Common Neutropenia Thrombocytopenia Leucopenia Anaemia
Slovenian: Žilne bolezni pogosti globoka venska tromboza občasni globoka venska tromboza
English: • The capsule shell contains: gelatin, titanium dioxide (E171), indigotine (E132), yellow iron oxide
Slovenian: • Ovojnica kapsule vsebuje: želatino, titanov dioksid (E171), indigotin (E132), rumeni železov oksid (E172) in belo črnilo.
English: CARTON
Slovenian: VO-deks
English: EU/1/13/850/006 (Pack size of 14 hard capsules) EU/1/13/850/002 (Pack size of 21 hard capsules)
Slovenian: EU/1/13/850/006 (velikost pakiranja 14 trdih kapsul) EU/1/13/850/002 (velikost pakiranja 21 trdih kapsul)
English: EU/1/13/850/008 (Pack size of 14 hard capsules) EU/1/13/850/004 (Pack size of 21 hard capsules)
Slovenian: EU/1/13/850/008 (velikost pakiranja 14 trdih kapsul) EU/1/13/850/004 (velikost pakiranja 21 trdih kapsul)
English: EU/1/13/850/007 (Pack size of 14 hard capsules) EU/1/13/850/003 (Pack size of 21 hard capsules)
Slovenian: EU/1/13/850/007 (velikost pakiranja 14 trdih kapsul) EU/1/13/850/003 (velikost pakiranja 21 trdih kapsul)
English: Interstitial lung disease
Slovenian: Bolezni jeter
English: EU/1/13/850/003 EU/1/13/850/007
Slovenian: EU/1/13/850/007
English: EU/1/13/850/005 (Pack size of 14 hard capsules) EU/1/13/850/001 (Pack size of 21 hard capsules)
Slovenian: EU/1/13/850/005 (velikost pakiranja 14 trdih kapsul) EU/1/13/850/001 (velikost pakiranja 21 trdih kapsul)
English: Or
Slovenian: NE
English: EU/1/13/850/002 EU/1/13/850/006
Slovenian: EU/1/13/850/006
English: Common Depression Insomnia
Slovenian: Psihiatrične motnje zelo pogosti nespečnost pogosti depresija pogosti depresija nespečnost
English: 90 (3 x 30) tablets (multipack)
Slovenian: 90 (3 × 30) filmsko obloženih tablet (večkratno pakiranje)
English: 30 tablets
Slovenian: 30 filmsko obloženih tablet
English: London, 25 June 2009 Doc.
Slovenian: London, 25. junija 2009 Sklic dok.
English: Ref. EMEA/409402/2009 EMEA/H/C/995
Slovenian: EMEA/H/C/995
English: Factive was expected to be used to treat the following bacterial infections in adults:
Slovenian: Zdravilo Factive naj bi se uporabljalo za zdravljenje naslednjih bakterijskih okužb pri odraslih:
English: The main measures of effectiveness for the studies were based on the number of patients who got better after treatment.
Slovenian: Glavno merilo učinkovitosti za študije je temeljilo na številu bolnikov, katerih stanje se je po zdravljenju izboljšalo.
English: The effects of Factive were first tested in experimental models before being studied in humans.
Slovenian: Učinki zdravila Factive so bili najprej preizkušeni na poskusnih modelih, nato pa so jih raziskali pri ljudeh.
English: Questions and answers on the withdrawal of the marketing authorisation application for Factive gemifloxacin
Slovenian: Vprašanja in odgovori v zvezi z umikom vloge za dovoljenje za promet z zdravilom Factive gemifloksacin
English: The seven-day treatment was not considered acceptable because of the risk of side effects.
Slovenian: Sedemdnevno zdravljenje ni štelo za sprejemljivo zaradi tveganja pojava neželenih učinkov.
English: It is expected to work by blocking the action of two bacterial enzymes called DNA gyrase and topoisomerase IV, which are needed to make and repair bacterial DNA.
Slovenian: Delovalo naj bi zaviranjem delovanja dveh bakterijskih encimov, imenovanih DNK giraza in topoizomeraza IV, ki sta potrebna za tvorbo in popravilo bakterijske DNK.
English: The CHMP was concerned that Factive may be more genotoxic (harmful to the DNA, the genetic material in cells) and that it may therefore cause more damage to the DNA than other fluoroquinolones.
Slovenian: CHMP je imel zadržke, da bi bilo zdravilo Factive lahko bolj genotoksično (škodljivo za DNK, genetsko gradivo v celicah) in bi zato lahko bolj poškodovalo DNK kot drugi fluorokinoloni.