FrancophonIA/ELRC3.0 huggingface dataset:
English: The recommended scoring system to evaluate the IHC staining patterns is as stated in Table 3:
Slovenian: Priporočen način vrednotenja rezultatov obarvanja preparatov po metodi IHC je naveden v preglednici 3.
English: The final OS results from the joint analysis of studies NSABP B-31 and NCCTG N9831 are summarised in Table 8 below:
Slovenian: Končni rezultati za celokupno preživetje iz skupne analize študij NSABP B-31 in NCCTG N9831 so povzeti v spodnji preglednici 8.
English: Tumour cell cluster with a faint ⁄ barely perceptible membranous reactivity irrespective of percentage of tumour cells stained
Slovenian: Skupek tumorskih celic ima bledo, komaj zaznavno obarvanje membrane, ne glede na odstotek obarvanih tumorskih celic.
English: Patients with MBC or MGC should be treated with Herzuma until progression of disease.
Slovenian: Bolnike z metastatskim rakom dojk ali metastatskim rakom želodca je treba z zdravilom Herzuma zdraviti do napredovanja bolezni.
English: *Co-primary endpoint of DFS of 1 year versus observation met the pre-defined statistical boundary **Final analysis (including crossover of 52% of patients from the observation arm to trastuzumab) *** There is a discrepancy in the overall sample size due to a small number of patients who were randomised after the cut-off date for the 12-month median follow-up analysis
Slovenian: ***V celokupni velikosti vzorca je neskladje zaradi majhnega števila bolnikov, ki so jih randomizirali po preteku datuma, do katerega so upoštevali podatke za analizo po mediano 12-mesečnem spremljanju.
English: Primary efficacy analysis DFS hazard ratios (95% CI) p-value p<0.0001
Slovenian: Primarna analiza učinkovitosti Razmerje ogroženosti za preživetje brez bolezni (95-% IZ) p-vrednost p < 0,0001
English: Patients are eligible for Herzuma treatment if they show strong HER2 overexpression as described by a 3+ score by IHC or a positive FISH or CISH result.
Slovenian: Za zdravljenje z zdravilom Herzuma so primerni bolniki, katerih rezultat čezmernega izražanja HER2 po metodi IHC znaša 3+ ali bolniki, katerih rezultat metod FISH ali CISH je pozitiven.
English: In the neoadjuvant-adjuvant treatment setting, study MO16432, a multicentre randomised trial, was designed to investigate the clinical efficacy of concurrent administration of trastuzumab with neoadjuvant chemotherapy including both an anthracycline and a taxane, followed by adjuvant trastuzumab, up to total treatment duration of 1 year.
Slovenian: Študija MO16432 je bila multicentrično randomizirano preskušanje na področju neoadjuvantnoadjuvantnega zdravljenja, zasnovano za proučevanje klinične učinkovitosti sočasnega dajanja trastuzumaba in neoadjuvantne kemoterapije, ki je vsebovala antraciklin in taksan.
English: Response rate (95% CI)
Slovenian: Delež odgovora (95-% IZ)
English: L-histidine hydrochloride L-histidine α,α-trehalose dihydrate Polysorbate 20
Slovenian: 6.1 Seznam pomožnih snovi L-histidinijev klorid L-histidin ,-trehaloza dihidrat Polisorbat 20
English: Risk factors for a cardiac event identified in four large adjuvant studies included advanced age (> 50 years), low LVEF (< 55%) at baseline, prior to or following the initiation of paclitaxel treatment, decline in LVEF by 10 - 15 points, and prior or concurrent use of anti-hypertensive medicinal products.
Slovenian: Dejavniki tveganja za pojav neželenega učinka, povezanega s srcem, ki so jih opazili v štirih velikih adjuvantnih študijah, so vključevali starost (> 50 let), majhno osnovno vrednost LVEF (< 55%),
English: Table 4 Efficacy results from the monotherapy and combination therapy studies
Slovenian: Rezultati učinkovitosti iz študij monoterapije in kombiniranega zdravljenja
English: Median TTP (months) (95% CI)
Slovenian: Mediana časa odgovora (meseci) (razpon) Mediana TTP (meseci) (95-% IZ)
English: - intravenous cyclophosphamide, at 600 mg/m over 30 minutes, given every 3 weeks for
Slovenian: - ciklofosfamid intravensko - 600 mg/m v 30 minutah, vsake 3 tedne, 4 cikle.
English: Breast cancer and gastric cancer
Slovenian: Rak dojk in rak želodca Trajanje zdravljenja
English: There was no evidence of acute or multiple dose-related toxicity in studies of up to 6 months, or reproductive toxicity in teratology, female fertility or late gestational toxicity/placental transfer studies.
Slovenian: V študijah teratogenosti, ženske plodnosti ali pozne gestacijske toksičnosti/placentnega prehoda, ki so trajale do šest mesecev, niso ugotovili akutne ali z večkratnim odmerjanjem povezane toksičnosti ali vpliva na razmnoževanje.
English: Surgical specimen - staining pattern
Slovenian: Kirurški vzorci - videz preparata po barvanju
English: Table 2 Recommended scoring system to evaluate the IHC staining patterns in breast cancer
Slovenian: Priporočeno točkovanje za vrednotenje obarvanja preparatov po metodi IHC pri raku želodca
English: Herzuma 150 mg powder for concentrate for solution for infusion Herzuma 420 mg powder for concentrate for solution for infusion
Slovenian: Herzuma 150 mg prašek za koncentrat za raztopino za infundiranje Herzuma 420 mg prašek za koncentrat za raztopino za infundiranje
English:  Severe dyspnoea at rest due to complications of advanced malignancy or requiring supplementary oxygen therapy.
Slovenian: • Pri bolnikih, ki imajo hudo dispnejo v mirovanju zaradi komplikacij napredovale maligne bolezni, ali pri tistih, ki potrebujejo zdravljenje s kisikom.
English: Single doses of Herzuma alone greater than 10 mg/kg have not been administered in the clinical trials; a maintenance dose of 10 mg/kg q3w following a loading dose of 8 mg/kg has been studied in a clinical trial with metastatic gastric cancer patients.
Slovenian: Enkratnih odmerkov zdravila Herzuma samega, večjih od 10 mg/kg, v kliničnih preskušanjih niso dajali.
English: Overall survival, median months Progression-free survival, median months
Slovenian: Preživetje brez napredovanja bolezni, mediana (meseci) Čas do napredovanja bolezni, mediana (meseci) Celokupni odgovor na zdravljenje, %
English: - intravenous docetaxel - 75 mg/m2 as an intravenous infusion over 1 hour, given every 3 weeks for 6 cycles (day 2 of cycle 1, then day 1 of each subsequent cycle)
Slovenian: - docetaksel intravensko - 75 mg/m v obliki intravenske infuzije v 1 uri, vsake 3 tedne, skupaj 6 ciklov (na 2. dan prvega cikla z docetakselom, nato na 1. dan vsakega nadaljnjega cikla).
English: Table 5 Efficacy results from the non-comparative monotherapy and combination therapy studies
Slovenian: Preglednica 5 navaja rezultate učinkovitosti monoterapije in kombiniranega zdravljenja iz študij brez primerjalne skupine.
English: Sepsis
Slovenian: Norge
English: A faint/barely perceptible membrane staining is detected in > 10% of the tumour cells.
Slovenian: Bledo, komaj zaznavno obarvanje membrane je prisotno pri > 10 % tumorskih celic.
English: Each vial of Herzuma is reconstituted with 7.2 mL of sterile water for injection (not supplied).
Slovenian: Vsebino viale zdravila Herzuma rekonstituiramo s 7,2 ml sterilne vode za injekcije (ni dodana).
English: Rare side effects (may affect up to 1 in 1000 people):
Slovenian: Redki neželeni učinki (pojavijo se lahko pri največ 1 od 1000 bolnikov):
English: Table 6 Efficacy results from study BO16348
Slovenian: Rezultati učinkovitosti študije BO16348 Mediani čas spremljanja 12 mesecev
English: Each vial of Herzuma is reconstituted with 20 mL of sterile water for injection (not supplied).
Slovenian: Vsebino viale zdravila Herzuma rekonstituiramo s 20 ml sterilne vode za injekcije (ni dodana).
English: Bradycardia
Slovenian: DCarbH
English: A: doxorubicin; C: cyclophosphamide; P: paclitaxel; D: docetaxel; Carb: carboplatin; H: trastuzumab; CI = confidence interval * At the time of the definitive analysis of DFS.
Slovenian: A: doksorubicin; C: ciklofosfamid; P: paklitaksel; D: docetaksel; Carb: karboplatin; H: trastuzumab IZ = interval zaupanja * V času končne analize preživetja brez bolezni.
English: • throat infections
Slovenian: • okužbe grla
English: This yields a 21 mL solution for single-dose use, containing approximately 21 mg/mL trastuzumab, at a pH of approximately 6.0.
Slovenian: Rekonstitucija da 21 ml raztopine za enkratno uporabo, ki vsebuje približno 21 mg/ml trastuzumaba, s pH približno 6,0.
English: - intravenous docetaxel - 100 mg/m as an intravenous infusion over 1 hour, given every 3 weeks for 4 cycles (day 2 of first docetaxel cycle, then day 1 of each subsequent cycle)
Slovenian: Odmerjanje docetaksela je bilo naslednje: - docetaksel intravensko - 100 mg/m v obliki intravenske infuzije v 1 uri, vsake 3 tedne, skupaj 4 cikle (na 2. dan prvega cikla, potem pa na 1. dan vsakega nadaljnjega cikla)
English: Tumour cell cluster with a weak to moderate complete, basolateral or lateral membranous reactivity irrespective of percentage of tumour cells stained
Slovenian: Skupek tumorskih celic ima šibko do srednje močno obarvane celotne, bazolateralne ali lateralne membrane, ne glede na odstotek obarvanih tumorskih celic.
English: • haemorrhoids
Slovenian: • dihalna stiska
English: How to store Herzuma
Slovenian: Shranjevanje zdravila Herzuma
English: The reconstituted Herzuma solution contains 21 mg/mL of trastuzumab.
Slovenian: Pripravljena raztopina zdravila Herzuma vsebuje 21 mg/ml trastuzumaba.
English:  Paclitaxel 175 mg/m administered 3-weekly for 4 cycles,
Slovenian: • paklitaksel 175 mg/m 2, dan enkrat na tri tedne, 4 cikle;
English: When trastuzumab was administered after completion of adjuvant chemotherapy NYHA Class III - IV heart failure was observed in 0.6% of patients in the one-year arm after a median follow-up of 12 months.
Slovenian: Srčno popuščanje razreda III-IV po NYHA se je po mediani časa spremljanja 12 mesecev pojavilo pri 0,6 % bolnikov v skupini, ki se je s trastuzumabom po zaključku adjuvantne kemoterapije zdravila eno leto.
English: fever, dyspnoea, hypotension, wheezing, bronchospasm, tachycardia, reduced oxygen saturation, respiratory distress, rash, nausea, vomiting and headache (see section 4.4).
Slovenian: Te reakcije vključujejo mrzlico, zvišano telesno temperaturo, dispnejo, hipotenzijo, piskanje, bronhospazem, tahikardijo, zmanjšano nasičenost s kisikom, dihalno stisko, izpuščaj, navzeo, bruhanje in glavobol (glejte poglavje 4.4).
English: Cardiac dysfunction
Slovenian: Srčne bolezni
English: White to pale yellow lyophilised powder.
Slovenian: prašek za koncentrat za raztopino za infundiranje bel do rahlo rumen liofiliziran prašek
English: Pleural effusion
Slovenian: Izpiranje trastuzumaba
English: Strong complete membrane staining is detected in > 10% of the tumour cells.
Slovenian: Močno obarvane celotne membrane pri > 10 % tumorskih celic.
English: Do not use Herzuma if you notice any particulate matter or discoloration prior to administration.
Slovenian: Če pred dajanjem opazite kakršne koli delce ali obarvanje, ne uporabljajte zdravila Herzuma.
English:  based on a loading dose of 8 mg trastuzumab/kg body weight, or a subsequent 3-weekly dose of 6 mg trastuzumab/kg body weight:
Slovenian: • za uvajalni odmerek 4 mg trastuzumaba/kg telesne mase ali za nadaljnje tedenske odmerke 2 mg trastuzumaba/kg telesne mase s pomočjo formule:
English: The recommended maintenance dose of Herzuma at three-weekly intervals is 6 mg/kg body weight, beginning three weeks after the loading dose.
Slovenian: Priporočen vzdrževalni odmerek zdravila Herzuma je 6 mg/kg telesne mase po 3 tednih od prejema uvajalnega odmerka, in nato v tritedenskih razmakih.
English: Acute respiratory distress syndrome Not known Bronchospasm
Slovenian: Pogostnost dihalna stiska neznano odpoved dihal neznano pljučni infiltrati neznano akutni pljučni edem neznano akutni respiratorni distresni sindrom (ARDS)
English: Volume (mL) = Body weight (kg) x dose (8 mg/kg for loading or 6 mg/kg for maintenance) 21 (mg/mL, concentration of reconstituted solution)
Slovenian: • za uvajalni odmerek 8 mg trastuzumaba/kg telesne mase ali za nadaljnje tritedenske odmerke 6 mg trastuzumaba/kg telesne mase s pomočjo formule: volumen (ml) = telesna masa (kg) x odmerek (8 mg/kg za uvajanje ali 6 mg/kg za vzdrževanje) 21 (mg/ml, koncentracija pripravljene raztopine)
English: Each vial of Herzuma is reconstituted with 7.2 mL of water for injections (not supplied).
Slovenian: Vsebino viale zdravila Herzuma raztopimo v 7,2 ml vode za injekcije (ni dodana).
English: Weak to moderate complete, basolateral or lateral membranous reactivity in ≥ 10% of tumour cells
Slovenian: Šibko do srednje močno obarvane celotne, bazolateralne ali lateralne membrane pri > 10 % tumorskih celic.
English: Strong complete, basolateral or lateral membranous reactivity in ≥ 10% of tumour cells
Slovenian: Močno obarvane celotne, bazolateralne ali lateralne membrane pri > 10 % tumorskih celic.
English: Glomerulonephritis membranous
Slovenian: Pogostnost membranski glomerulonefritis neznano glomerulonefropatija neznano ledvična odpoved neznano
English: Distant disease-free survival - No. patients with event - No. patients without event P-value versus observation Hazard ratio versus observation
Slovenian: Preživetje brez pojava oddaljenih metastaz - št. bolnikov z dogodkom 184 (10,9 %) - št. bolnikov brez dogodka P-vrednost v primerjavi z opazovanjem
English: Hazard ratio versus AC→P (95% CI)
Slovenian: Razmerje ogroženosti v primerjavi z AC → P (95-% IZ)
English: Herzuma and anthracyclines should not be given concurrently in combination in the adjuvant treatment setting.
Slovenian: Pri zdravljenju metastatskega raka dojk kombinacije zdravila Herzuma in antraciklinov ne smemo dajati sočasno.
English: Each vial of Herzuma is reconstituted with 20 mL of water for injections (not supplied).
Slovenian: Vsebino viale zdravila Herzuma raztopimo v 20 ml vode za injekcije (ni dodana).
English: Herzuma 420 mg powder for concentrate for solution for infusion
Slovenian: Herzuma 420 mg prašek za koncentrat za raztopino za infundiranje
English: Herzuma 150 mg powder for concentrate for solution for infusion
Slovenian: Herzuma 150 mg prašek za koncentrat za raztopino za infundiranje
English: Trastuzumab washout
Slovenian: • vnetje jeter
English: • respiratory distress
Slovenian: • okužba pljuč
English: Herzuma 420 mg powder for concentrate for solution for infusion trastuzumab
Slovenian: Herzuma 420 mg prašek za koncentrat za raztopino za infundiranje trastuzumab
English: Hazard ratio vs AC→D (95% CI) p-value
Slovenian: Razmerje ogroženosti v primerjavi z AC → D (95-% IZ) p-vrednost
English: The median overall survival for the high HER2 expressing group was 11.8 months versus 16 months, HR 0.65 (95% CI 0.51 - 0.83) and the median progression free survival was 5.5 months versus 7.6 months, HR 0.64 (95% CI 0.51 - 0.79) for FP versus FP + H, respectively.
Slovenian: Mediana celokupnega preživetja v skupini, ki je imela visoko izražen HER2, je bila 11,8 meseca za skupino, ki ni prejemala trastuzumaba, v primerjavi s 16 meseci za skupino, ki je prejemala tudi trastuzumab - razmerje ogroženosti 0,65 (95-% interval zaupanja; 0,51-0,83).
English: A weak to moderate complete membrane staining is detected in > 10% of the tumour cells.
Slovenian: Šibko do srednje močno obarvane celotne membrane pri > 10 % tumorskih celic.
English: Hazard ratio vs AC→P (95% CI) p-value
Slovenian: Razmerje ogroženosti v primerjavi z AC → P (95-% IZ) p-vrednost
English: Herzuma 150 mg powder for concentrate for solution for infusion trastuzumab
Slovenian: Herzuma 150 mg prašek za koncentrat za raztopino za infundiranje trastuzumab
English: Tumour lysis syndrome
Slovenian: • bolezni ledvic
English: Patients with EBC should be treated with Herzuma for 1 year or until disease recurrence, whichever occurs first; extending treatment in EBC beyond one year is not recommended (see section 5.1).
Slovenian: Podaljšanje zdravljenja zgodnjega raka dojk na več kot eno leto ni priporočljivo (glejte poglavje 5.1).
English: • itchiness
Slovenian: • tesnoba
English: Overall survival (death) - No. patients with event - No. patients without event P-value versus observation Hazard ratio versus observation
Slovenian: - št. bolnikov z dogodkom 40 (2,4 %) - št. bolnikov brez dogodka P-vrednost v primerjavi z opazovanjem
English:  additional cycles of adjuvant trastuzumab (to complete 1 year of treatment) The efficacy results from Study MO16432 are summarised in Table 12.
Slovenian: Rezultati učinkovitosti študije MO16432 so povzeti v preglednici 12.
English: • diarrhoea
Slovenian: • hemoroidi
English: A 20 mL clear glass type I vial with fluroTec-coated butyl rubber stopper containing 150 mg of trastuzumab.
Slovenian: Herzuma 150 mg prašek za koncentrat za raztopino za infundiranje Ena 20-ml viala iz prozornega stekla tipa I z butilnim gumijastim zamaškom, prevlečenim s fluroTecom, ki vsebuje 150 mg trastuzumaba.
English: Tel: + 372 6 644 550
Slovenian: Orion Pharma Eesti OÜ Tel: + 372 6 644 550
English: Immune system disorders Hypersensitivity
Slovenian: Bolezni imunskega sistema preobčutljivost pogosto anafilaktična reakcija neznano anafilaktični šok neznano
English: The efficacy results from the monotherapy and combination therapy studies are summarised in Table
Slovenian: Rezultati učinkovitosti monoterapije in kombiniranega zdravljenja iz študij brez primerjalne skupine
English: Determine the volume of the solution required:  based on a loading dose of 4 mg trastuzumab/kg body weight, or a subsequent weekly dose of 2 mg trastuzumab/kg body weight:
Slovenian: • za uvajalni odmerek 4 mg trastuzumaba/kg telesne mase ali za nadaljnje tedenske odmerke 2 mg trastuzumaba/kg telesne mase s pomočjo formule: volumen (ml) = telesna masa (kg) x odmerek (4 mg/kg za uvajanje ali 2 mg/kg za vzdrževanje)
English: Median duration of follow up was 1.8 years in the AC→P arm and 2.0 years in the AC→PH arm ** Median duration of long term follow-up for the joint analysis clinical studies was 8.3 years (range: 0.1 to
Slovenian: Mediana spremljanja je bila 1,8 leta za bolnike v skupini AC → P in 2,0 leta za bolnike v skupini AC → PH.
English: Back pain
Slovenian: • bolečina v hrbtu
English: What you need to know before you use Herzuma 3.
Slovenian: Kaj je zdravilo Herzuma in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo Herzuma Kako uporabljati zdravilo Herzuma Možni neželeni učinki
English: Median duration of response (months) (95% CI)
Slovenian: Delež odgovora (95-% IZ) Mediana časa odgovora (meseci) (95-% IZ) Mediana TTP (meseci) (95-% IZ) Mediana preživetja (meseci) (95-% IZ)
English: After a median follow-up of 12 months, the hazard ratio (HR) for disease free survival (DFS) was 0.54 (95% CI 0.44, 0.67) which translates into an absolute benefit, in terms of a 2-year disease-free survival rate, of 7.6 percentage points (85.8% versus 78.2%) in favour of the trastuzumab arm.
Slovenian: Po mediano 12-mesečnem spremljanju je bilo razmerje ogroženosti za preživetje brez bolezni 0,54 (95-% IZ: 0,44; 0,67).
English: Event-free survival
Slovenian: Preživetje brez bolezni
English: analysis DFS hazard ratios (95% CI) p-value p<0.0001
Slovenian: Razmerje ogroženosti v primerjavi z AC → D (95-% IZ) p-vrednost preživetja): število bolnikov z dogodkom p = 0,0024
English: A 50 mL clear glass type I vial with butyl rubber stopper containing 420 mg of trastuzumab.
Slovenian: Herzuma 420 mg prašek za koncentrat za raztopino za infundiranje Ena 50-ml viala iz prozornega stekla tipa I z butilnim gumijastim zamaškom, ki vsebuje 420 mg trastuzumaba.
English: • skin rashes
Slovenian: • kožni izpuščaj
English: Doxorubicin and cyclophosphamide were administered concurrently as follows:
Slovenian: Kapecitabin ali 5-fluorouracil so dajali skupaj s:
English: Also, as already stated earlier, the US population is not considered representative of the EU population.
Slovenian: Kot je bilo že navedeno, se populacija ZDA tudi ne šteje za reprezentativno za populacijo EU.
English: This means that 3 options are possible:
Slovenian: To pomeni, da so na voljo tri možnosti:
English: The dose recommendation consists of two phases:
Slovenian: Priporočilo za odmerjanje obsega dve fazi:
English: • Interim analysis of the European study 14701
Slovenian: • Vmesna analiza evropske študije 14701
English: Only very limited data from the interim analysis are currently available.
Slovenian: Trenutno je razpoložljivih le zelo malo podatkov iz vmesne analize.
English: Overall summary of the scientific evaluation of Yvidually and associated names (see Annex I)
Slovenian: Splošni povzetek znanstvenega vrednotenja zdravila Yvidually in povezanih imen (glejte Prilogo I)
English: Mandatory phase (Day 1 to day 24):
Slovenian: Obvezna faza (od 1. do 24. dneva):
English: Or:
Slovenian: ali:
English: • The Committee considered the notification of the referral triggered by France under Article 29(4) of Council Directive 2001/83/EC.
Slovenian: • Odbor je upošteval obvestilo o napotitvenem postopku, ki ga je sprožila Francija skladno s členom 29(4) Direktive Sveta 2001/83/ES;
English: • The Committee reviewed all available data submitted by the applicant to address the potential serious risk to public health, in particular concerning the contraceptive efficacy of the proposed extended dosing regimen.
Slovenian: • Odbor je pregledal vse razpoložljive podatke, ki jih je predložil predlagatelj, da bi razrešil vprašanja morebitnega resnega tveganja za javno zdravje, zlasti kontracepcijske učinkovitosti predlaganega podaljšanega režima odmerjanja;
English: The applicant should submit to the National Competent Authorities the final results of the study 14701by 28 February 2013.
Slovenian: Predlagatelj mora pristojnim nacionalnim organom končne rezultate študije 14701 predložiti do 28. februarja 2013.
English: However only raw data on bleeding patterns were submitted and no analyses in this regard are available.
Slovenian: Vendar pa so bili predloženi le neobdelani podatki o vzorcih krvavitev in analize tega vidika niso na voljo.
English: Although the final results will only be available in 2013, this PI is considered conclusive in terms of precision.
Slovenian: Čeprav bodo končni rezultati na voljo šele leta 2013, je ta Pearlov indeks z vidika točnosti prepričljiv.
English: In this study, two versions of the dispenser - with or without acoustic alarm - are compared.
Slovenian: V tej študiji so primerjali dve različici razdelilnika - z zvočnim alarmom in brez njega.
English: Each film-coated tablet of Yvidually contains 3 mg of drospirenone (DRSP) + 20 micrograms of ethinylestradiol (EE).
Slovenian: Vsaka filmsko obložena tableta Yvidually vsebuje 3 mg drospirenona (DRSP) + 20 mikrogramov etinilestradiola (EE).
English: In summary, usability of the dispenser is considered acceptable, and confirmed by the interim data of the additional dispenser study.
Slovenian: Skratka, uporabnost razdelilnika se šteje za sprejemljivo, kar potrjujejo vmesni podatki dodatne študije razdelilnika.
English: Flexible phase (Day 25 to Day 120)
Slovenian: Prilagodljiva faza (od 25. do 120. dneva):
English: Only usability testing required by the Medical Device Directive 93/42 has been performed, which is considered to be acceptable since a medical device that is intended to administer a medicinal product is governed by the Directive 93/42, without prejudice to the provisions of Directive 2001/83 with regard to the medicinal product.
Slovenian: Opravljeno je bilo samo testiranje uporabnosti, ki ga zahteva Direktiva o medicinskih pripomočkih 93/42; to velja za sprejemljivo, ker medicinske pripomočke, namenjene aplikaciji zdravila, ureja Direktiva 93/42, brez poseganja v določbe Direktive 2001/83 v zvezi z zdravilom.
English: US study A48294
Slovenian: Ameriška študija A48294
English: Overall conclusion
Slovenian: Skupni zaključek
English: Clinical studies The 2 phase III studies were conducted from 2005 to 2009 (study A40196 in Europe and Canada and study A48294 in the US).
Slovenian: Klinične študije Med letoma 2005 in 2009 sta bili opravljeni dve študiji III. faze (študija A40196 v Evropi in Kanadi ter študija A48294 v ZDA).