FrancophonIA/ELRC3.0 huggingface dataset:
English: The final OS results from the joint analysis of studies NSABP B-31 and NCCTG N9831 are summarized in Table 8 below:
Slovenian: Končni rezultati za celokupno preživetje iz skupne analize preskušanj NSABP B-31 in NCCTG N9831 so povzeti v spodnji preglednici 8.
English: 8mg/kg + 6mg/kg q3w
Slovenian: 8 mg/kg + 6mg/kg na 3 tedne
English: No. patients with event
Slovenian: Število bolnikov z dogodkom 46
English: Weekly dosing in metastatic breast cancer The efficacy results from the monotherapy and combination therapy studies are summarised in Table
Slovenian: Tedensko odmerjanje pri metastatskem raku dojk Preglednica 4 navaja rezultate učinkovitosti iz študij monoterapije in kombiniranega zdravljenja.
English: Reactions include chills, 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, piskajoče dihanje, bronhospazem, tahikardijo, zmanjšano nasičenost s kisikom, dihalno stisko, izpuščaj, navzeo, bruhanje in glavobol (glejte poglavje 4.4).
English: clearance (CL), the central compartment volume (Vc)) and population-predicted steady-state exposures (Cmin, Cmax and AUC).
Slovenian: Bolniki z MBC in EBC so imeli podobne farmakokinetične parametre (npr. očistek, volumen centralnega prostora (Vc)) in izpostavljenosti v stanju dinamičnega ravnovesja (Cmin, Cmax in AUC), predvidene za populacijo.
English: In addition a post-hoc exploratory analysis was performed on the data sets from the joint analysis (JA) NSABP B-31/NCCTG N9831* and BCIRG006 clinical studies combining DFS events and symptomatic cardiac events and summarised in Table 11:
Slovenian: Post-hoc raziskovalna analiza podatkov iz skupne analize kliničnih preskušanj NSABP B- 31/NCCTG N9831* in BCIRG 006, ki vključujejo dogodke preživetja brez ponovitve bolezni in simptomatske srčne dogodke.
English: The data also suggested that the pharmacokinetics of cisplatin were not affected by concurrent use of capecitabine or by concurrent use of capecitabine plus trastuzumab.
Slovenian: Podatki so pokazali tudi, da sočasna uporaba kapecitabina ali sočasna uporaba kapecitabina in trastuzumaba ni vplivala na farmakokinetiko cisplatina.
English: - The other ingredient(s) are L-histidine hydrochloride monohydrate, L-histidine, sucrose, polysorbate 20.
Slovenian: - Druge sestavine zdravila so L-histidinijev klorid monohidrat, L-histidin, saharoza in polisorbat
English: Distant recurrence No. patients with event p=0.0008
Slovenian: Pojav oddaljenih metastaz: število bolnikov z dogodkom p = 0,0008
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: In all patients cardiac function should be monitored during treatment (e.g. every 12 weeks).
Slovenian: Med zdravljenjem je treba nadzorovati delovanje srca pri vseh bolnikih (npr. vsakih 12 tednov), kar olajša razpoznavo bolnikov, pri katerih se pojavljajo motnje v delovanju srca.
English: Respiratory distress
Slovenian: Pljučni zapleti
English: Signs and symptoms of cardiac dysfunction such as dyspnoea, orthopnoea, increased cough, pulmonary oedema, S3 gallop, or reduced ventricular ejection fraction, have been observed in patients treated with trastuzumab (see section 4.4).
Slovenian: Pri bolnikih, ki so se zdravili s trastuzumabom, so opazili znake in simptome motenj v delovanju srca, kot so dispneja, ortopneja, povečan kašelj, pljučni edem, galop S3 ali zmanjšan ventrikularni srčni iztis (glejte poglavje 4.4).
English: • abnormal or impaired blood clotting
Slovenian: • nenormalno ali slabše strjevanje krvi
English: Table 2 Recommended Scoring System to Evaluate the IHC Staining Patterns in Breast Cancer Score Staining pattern
Slovenian: Priporočeno točkovanje za vrednotenje obarvanja preparatov po metodi IHC pri raku želodca
English: Trazimera intravenous formulation is not intended for subcutaneous administration and should be administered via an intravenous infusion only.
Slovenian: Intravenska oblika zdravila Trazimera ni namenjena subkutanemu (podkožnemu) dajanju in se ga lahko daje le z intravensko infuzijo.
English: HER2 gene amplification should be detected using fluorescence in situ hybridisation (FISH) or chromogenic in situ hybridisation (CISH) of fixed tumour blocks.
Slovenian: Amplifikacijo gena HER2 določamo z metodo hibridizacije in situ, torej z metodo SISH ali FISH na fiksiranih blokih tumorskega tkiva.
English: * are summarized in Table 7.
Slovenian: Analiza je povzeta v preglednici 11.
English: Death (OS event) No. patients with event p=0.0024
Slovenian: Smrt (dogodek celokupnega preživetja): število bolnikov z dogodkom p = 0,0024
English: Table 16 Population Predicted PK Parameter Values at Steady State for Trastuzumab Intravenous Dosing Regimens in MBC, EBC and AGC Patients
Slovenian: Farmakokinetične vrednosti izpostavljenosti, predvidene za populacijo, v stanju dinamičnega ravnovesja za režima odmerjanja trastuzumaba v intravenski obliki pri bolnikih z MBC, EBC in AGC
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 zmerno obarvane celotne, bazolateralne ali lateralne membrane, ne glede na odstotek obarvanih tumorskih celic.
English: Tumour cell cluster with a strong complete, basolateral or lateral membranous reactivity irrespective of percentage of tumour cells stained
Slovenian: Skupek tumorskih celic ima močno obarvane celotne, bazolateralne ali lateralne membrane, ne glede na odstotek obarvanih tumorskih celic.
English: However, the majority of infusion-related reactions are mild to moderate in intensity (NCI-CTC grading system) and tend to occur earlier in treatment, i.e. during infusions one, two and three and lessen in frequency in subsequent infusions.
Slovenian: Običajno se pojavijo v zgodnejših fazah zdravljenja, torej med prvo, drugo in tretjo infuzijo, ter so manj pogoste pri naslednjih infuzijah.
English: Primary efficacy analysis DFS Hazard ratios (95% CI) p-value p<0.0001
Slovenian: Primarna analiza učinkovitosti Razmerje ogroženosti za preživetje brez ponovitve bolezni (95 % IZ) p-vrednost p < 0,0001
English: This yields a 20.6 mL solution for single-dose use, containing approximately 21 mg/mL trastuzumab, at a pH of approximately 6.0.
Slovenian: Rekonstitucija da 20,6 ml raztopine za enkratno uporabo, ki vsebuje približno 21 mg/ml trastuzumaba, s pH vrednostjo približno 6,0.
English: Doxorubicin and cyclophosphamide were administered concurrently as follows:
Slovenian: Odmerjanje doksorubicina in ciklofosfamida, ki so ju dajali sočasno, je bilo naslednje:
English: The reconstituted Trazimera solution contains 21 mg/mL of trastuzumab.
Slovenian: Pripravljena raztopina zdravila Trazimera vsebuje 21 mg/ml trastuzumaba.
English: - intravenous cyclophosphamide, at 600 mg/m 2 over 30 minutes, given every 3 weeks for
Slovenian: - ciklofosfamid intravensko - 600 mg/m 2 v 30 minutah, vsake 3 tedne, 4 cikle.
English: Biopsy specimen - staining pattern
Slovenian: Vzorci biopsijevidez preparata po barvanju
English: Hormone receptor positive patients must also have failed hormonal therapy, unless patients are unsuitable for these treatments.
Slovenian: Bolniki s hormonsko odvisnimi tumorji, pri katerih je bolezen napredovala po predhodnem hormonskem zdravljenju, razen če za takšno zdravljenje niso bili primerni;
English: Strong complete membrane staining is detected in >10% of the tumour cells.
Slovenian: Močno obarvanje celotne membrane pri > 10 % tumorskih celic.
English: 1) Using a sterile syringe, slowly inject the appropriate volume (as noted above) of sterile water for injections in the vial containing the lyophilised Trazimera.
Slovenian: 1) Uporabite sterilno injekcijsko brizgo in počasi injicirajte ustrezen volumen (naveden zgoraj)
English: This yields a 7.4 mL solution for single-dose use, containing approximately 21 mg/mL trastuzumab, at a pH of approximately 6.0.
Slovenian: Rekonstitucija da 7,4 ml raztopine za enkratno uporabo, ki vsebuje približno 21 mg/ml trastuzumaba, s pH vrednostjo približno 6,0.
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, plodnosti pri ženskah ali pozne gestacijske toksičnosti/placentnega prehoda, ki so trajale do 6 mesecev, niso ugotovili akutne ali z večkratnim odmerjanjem povezane toksičnosti.
English: Table 15 Population Predicted Steady State PK Exposure Values (median with 5th - 95th Percentiles) for Trastuzumab Intravenous Dosing Regimens in MBC, EBC and AGC Patients
Slovenian: Farmakokinetične vrednosti izpostavljenosti, predvidene za populacijo, v stanju dinamičnega ravnovesja (mediana s 5.-95. percentilom) za režima odmerjanja trastuzumaba v intravenski obliki pri bolnikih z MBC, EBC in AGC
English: Anaphylactic reaction
Slovenian: +anafilaktična reakcija neznana
English: • depression
Slovenian: • slabost
English: Study WO16229: loading dose 8 mg/kg, followed by 6 mg/kg 3 weekly schedule Study MO16982: loading dose 6 mg/kg weekly x 3; followed by 6 mg/kg 3-weekly schedule Study BO15935
Slovenian: Študija WO16229: polnilni odmerek 8 mg/kg, čemur je sledil odmerek 6 mg/kg po 3-tedenskem režimu.
English: This yields a 20.6 mL solution for single-dose use, containing approximately 21 mg/mL trastuzumab.
Slovenian: Rekonstitucija da 20,6 ml raztopine za enkratno uporabo in vsebuje približno 21 mg/ml trastuzumaba.
English: • skin rashes
Slovenian: • kožni izpuščaji
English: - intravenous push doxorubicin, at 60 mg/m 2, given every 3 weeks for 4 cycles.
Slovenian: - doksorubicin v obliki intravenskega bolusa - 60 mg/m 2, vsake 3 tedne, 4 cikle;
English: A weak to moderate complete membrane staining is detected in >10% of the tumour cells.
Slovenian: Šibko do zmerno obarvanje celotne membrane pri > 10 % tumorskih celic.
English: Trazimera 150 mg powder for concentrate for solution for infusion Trazimera 420 mg powder for concentrate for solution for infusion trastuzumab
Slovenian: Trazimera 150 mg prašek za koncentrat za raztopino za infundiranje Trazimera 420 mg prašek za koncentrat za raztopino za infundiranje trastuzumab
English: Trazimera 150 mg powder for concentrate for solution for infusion Trazimera 420 mg powder for concentrate for solution for infusion
Slovenian: Trazimera 150 mg prašek za koncentrat za raztopino za infundiranje Trazimera 420 mg prašek za koncentrat za raztopino za infundiranje
English: Disease-free survival No. patients with event p=0.0003
Slovenian: Preživetje brez ponovitve bolezni: število bolnikov z dogodkom p = 0,0003
English: Trazimera 420 mg powder for concentrate for solution for infusion
Slovenian: Trazimera 420 mg prašek za koncentrat za raztopino za infundiranje
English: • abnormal thinking
Slovenian: • nenormalno razmišljanje bolezni ledvic
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 0.510.79) for FP versus FP + H, respectively.
Slovenian: Mediana celokupnega preživetja v skupini, ki je imela visoko izražen HER2, je bila 11,8 meseca v primerjavi s 16 meseci; razmerje ogroženosti 0,65 (95 % IZ: 0,51-0,83).
English: Patients with EBC should be treated with Trazimera 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 1 leto ni priporočljivo (glejte poglavje 5.1).
English: Reversibility of mild symptomatic and asymptomatic left ventricular dysfunction was demonstrated for 79.5% of patients.
Slovenian: Reverzibilnost blage simptomatske in asimptomatske disfunkcije levega prekata so dokazali pri
English: • haemorrhoids
Slovenian: • oglušelost
English: Anaphylactic shock
Slovenian: +anafilaktični šok neznana
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 medianem času spremljanja 12 mesecev pojavilo pri 0,6 % bolnikov v skupini, ki se je s trastuzumabom po zaključku adjuvantne kemoterapije zdravila 1 leto.
English: Trazimera 420 mg powder for concentrate for solution for infusion trastuzumab
Slovenian: Trazimera 420 mg prašek za koncentrat za raztopino za infundiranje trastuzumab
English: Talk to your doctor, pharmacist or nurse before you are given Trazimera if:
Slovenian: Preden boste prejeli zdravilo Trazimera, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro, če:
English: Instructions for Reconstitution:
Slovenian: - Navodilo shranite.
English: Duration of Response, Median months
Slovenian: Trajanje odgovora, mediana (meseci) 4,8
English: Median duration of response (months) (95% CI) Median TTP (months) (95% CI)
Slovenian: Mediana TTP (meseci) (95 % IZ)
English: Table 7 Summary of Efficacy results from the joint analysis of the NSABP B-31 and NCCTG N9831 trials at the time of the definitive DFS analysis
Slovenian: Povzetek rezultatov učinkovitosti iz skupne analize preskušanj NSABP B-31 in NCCTG N9831 v času končne analize preživetja brez ponovitve bolezni
English: - The NSABP B-31 and NCCTG N9831 studies that comprise the joint analysis were designed to investigate the clinical utility of combining trastuzumab treatment with paclitaxel following AC chemotherapy, additionally the NCCTG N9831 study also investigated adding trastuzumab sequentially to AC→P chemotherapy in patients with HER2 positive EBC following surgery.
Slovenian: Preskušanji NSABP B-31 in NCCTG N9831, ki imata skupno analizo, so zasnovali za proučevanje klinične koristi kombinacije zdravljenja s trastuzumabom in paklitakselom po kemoterapiji z antraciklinom (doksorubicinom) in ciklofosfamidom (kemoterapiji AC).
English: Reproduction studies have been conducted in Cynomolgus monkeys at doses up to 25 times that of the weekly human maintenance dose of 2 mg/kg trastuzumab intravenous formulation and have revealed no evidence of impaired fertility or harm to the foetus.
Slovenian: Študije o vplivu na sposobnost za razmnoževanje so opravili pri opicah Cynomolgus z odmerki, ki so bili do 25-krat večji od tedenskega vzdrževalnega odmerka intravenske oblike trastuzumaba pri ljudeh (2 mg/kg).
English: Retinal haemorrhage
Slovenian: Rekonstituirana raztopina
English: • Paclitaxel 175 mg/m2 administered 3-weekly for 4 cycles,
Slovenian: temu je sledil - paklitaksel 175 mg/m2, enkrat na 3 tedne, 4 cikle;
English: The recommended maintenance dose of Trazimera at three-weekly intervals is 6 mg/kg body weight, beginning three weeks after the loading dose.
Slovenian: Priporočeni vzdrževalni odmerek zdravila Trazimera je 6 mg/kg telesne mase po 3 tednih od prejema polnilnega odmerka in nato v 3-tedenskih razmakih.
English: • jaundice
Slovenian: • driska
English: Cardiac failure (congestive)
Slovenian: • vnetje očesne veznice (konjunktivitis)
English: Hazard Ratio vs AC→P (95% CI) p-value
Slovenian: Razmerje ogroženosti v primerjavi z AC → P (95 % IZ) p-vrednost
English: Hazard Ratio versus AC→P (95% CI)
Slovenian: Razmerje ogroženosti v primerjavi z AC → P (95 % IZ)
English: Distant recurrence No. patients with event p<0.0001
Slovenian: Pojav oddaljenih metastaz: število bolnikov z dogodkom p < 0,0001
English: Long term follow-up efficacy analysis DFS Hazard rations (95% CI) p-value p<0.0001
Slovenian: Razmerje ogroženosti za preživetje brez ponovitve bolezni (95 % IZ) p-vrednost p < 0,0001
English: Trastuzumab washout period was assessed following q1w or q3w intravenous administration using the population PK model.
Slovenian: Obdobje izpiranja trastuzumaba so ocenjevali po intravenski aplikaciji zdravila enkrat na teden ali enkrat na 3 tedne s pomočjo populacijskega farmakokinetičnega modela.
English: No staining is observed or membrane staining is observed in <10% of the tumour cells
Slovenian: Obarvanje ni prisotno ali pa so obarvane membrane pri < 10 % vseh tumorskih celic v preparatu.
English: Do not administer as an intravenous push or bolus.
Slovenian: Zdravila se ne sme dajati kot hitro intravensko infuzijo ali bolus.
English: Trazimera and anthracyclines should not be given concurrently in combination in the adjuvant treatment setting.
Slovenian: Pri zdravljenju metastatskega raka dojk kombinacije zdravila Trazimera in antraciklinov ne smemo dajati sočasno.
English: Trazimera 150 mg powder for concentrate for solution for infusion
Slovenian: Trazimera 150 mg prašek za koncentrat za raztopino za infundiranje
English: Do not use Trazimera if you notice any particulate matter or discoloration prior to administration.
Slovenian: Če pred dajanjem opazite kakršnekoli delce ali obarvanje, ne uporabite zdravila Trazimera.
English: Not known
Slovenian: nezanesljivo
English: Hazard Ratio vs AC→D (95% CI) p-value
Slovenian: Razmerje ogroženosti v primerjavi z AC → D (95 % IZ) p-vrednost
English: Ear and labyrinth disorders Deafness
Slovenian: Ušesne bolezni, vključno z motnjami labirinta oglušelost občasni
English: Papilloedema
Slovenian: Imunogenost
English: which was followed by • CMF on day 1 and 8 every 4 weeks for 3 cycles which was followed after surgery by • additional cycles of adjuvant trastuzumab (to complete 1 year of treatment)
Slovenian: po operaciji so sledili - dodatni cikli trastuzumaba, adjuvantno (do zaključka prvega leta zdravljenja).
English: Trazimera 150 mg powder for concentrate for solution for infusion trastuzumab
Slovenian: Trazimera 150 mg prašek za koncentrat za raztopino za infundiranje trastuzumab
English: The recommended maintenance dose at three-weekly intervals is 6 mg/kg body weight, beginning three weeks after the loading dose.
Slovenian: Priporočeni vzdrževalni odmerek je 6 mg/kg telesne mase po 3 tednih od prejema polnilnega odmerka in nato v 3-tedenskih razmakih.
English: Hazard Ratio vs AC→D (95% CI)
Slovenian: Razmerje ogroženosti v primerjavi z AC → D (95 % IZ)
English: Table 5 Efficacy Results from the Non-Comparative Monotherapy and Combination Therapy Studies
Slovenian: Rezultati učinkovitosti monoterapije in kombiniranega zdravljenja iz študij brez primerjalne skupine
English: Your doctor may prescribe Trazimera for the treatment of breast and gastric cancer when: • You have early breast cancer, with high levels of a protein called HER2.
Slovenian: Vaš zdravnik vam lahko zdravilo Trazimera predpiše za zdravljenje raka dojk in raka želodca, če:
English: In addition, terms reported in the post marketing setting are included in Table 1.
Slovenian: Poleg tega so v preglednici 1 navedeni tudi neželeni učinki o katerih so poročali v obdobju trženja zdravila.
English: Disease-free survival No. patients with event p<0.0001
Slovenian: Preživetje brez ponovitve bolezni: število bolnikov z dogodkom p < 0,0001
English: Death (OS event): No. patients with event p=0.014
Slovenian: Smrt (dogodek celokupnega preživetja): število bolnikov z dogodkom p = 0,014**
English: • muscle weakness
Slovenian: • mišična šibkost • zlatenica
English: • altered taste
Slovenian: • sprememba okušanja
English: • throat infections
Slovenian: • suhe oči okužbe grla
English: Mucosal inflammation
Slovenian: Bolezni živčevja
English: STATEMENT OF ACTIVE SUBSTANCE(S)
Slovenian: Analiza dolgoročnega spremljanja učinkovitosti**
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 - št. bolnikov brez dogodka
English: • neck pain
Slovenian: • tesnoba vnetje dojk
English: Urinary tract infection
Slovenian: Shranjevanje zdravila Trazimera
English: Response rate (95% CI) Median duration of response (months) (range) Median TTP (months) (95% CI)
Slovenian: Mediana časa odgovora (meseci) (95 % IZ)
English: Hepatocellular injury
Slovenian: • bolečina v kosteh hemoroidi
English: Most patients who developed CHF or asymptomatic cardiac dysfunction in pivotal trials improved with standard CHF treatment consisting of an angiotensinconverting enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB) and a beta-blocker.
Slovenian: To vključuje zaviralec angiotenzinske konvertaze ali zaviralec angiotenzinskih receptorjev in antagonist receptorjev beta.
English: Refer to the SmPC for paclitaxel, docetaxel or aromatase inhibitor for information on dose reduction or delays.
Slovenian: Za zmanjšanje odmerka ali odložitev zdravljenja s paklitakselom, docetakselom ali zaviralcem aromataze glejte njihove Povzetke glavnih značilnosti zdravila.
English: A: doxorubicin; C: cyclophosphamide; P: paclitaxel; D: docetaxel; Carb: carboplatin; H: trastuzumab CI = confidence interval
Slovenian: A = doksorubicin; C = ciklofosfamid; P = paklitaksel; H = trastuzumab; IZ = interval zaupanja
English: The risk of neutropenia may be slightly increased when trastuzumab is administered with docetaxel following anthracycline therapy.
Slovenian: Če trastuzumab dajemo z docetakselom po zdravljenju z antraciklini, je lahko tveganje za nevtropenijo rahlo povečano.
English: • inflammation of the liver
Slovenian: • depresija vnetje jeter
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: Posodobljeni rezultati analize preživetja brez ponovitve bolezni (stratificirano razmerje ogroženosti 0,61; 95 % IZ [0,54; 0,69]) so pokazali podobno korist glede preživetja brez ponovitve bolezni v primerjavi s končno primarno analizo preživetja brez ponovitve bolezni, ne glede na to, da je 24,8 % bolnikov v skupini AC→P prešlo na zdravljenje s trastuzumabom.
English: Content Concentration
Slovenian: Stična ovojnina Vsebina (koncentracija)
English: 4 single-dose kits (1 vial + 1 prefilled syringe + 1 vial connector + 2 needles)
Slovenian: 4 enoodmerni seti (1 viala + 1 napolnjena injekcijska brizga + 1 povezovalec viale + 2 igli)
English: 12 (3 x 4) singledose kits (1 vial + 1 pre-filled syringe + 1 vial connector + 2 needles) (multipack)
Slovenian: 12 (3 x 4) enoodmernih setov (1 viala + 1 napolnjena injekcijska brizga + 1 povezovalec viale + 2 igli) (skupno pakiranje)
English: 4 pre-filled pens + 1 needle
Slovenian: 4 napolnjeni injekcijski peresniki + 1 igla
English: 12 (3 x 4) prefilled pens + 3 needles (multipack)
Slovenian: 12 (3 x 4) napolnjenih injekcijskih peresnikov + 3 igle (skupno pakiranje)
English: 12 (3 x 4) prefilled pens (multipack)
Slovenian: 12 (3 x 4) napolnjenih injekcijskih peresnikov (skupno pakiranje)
English: The withdrawal letter can be found here.
Slovenian: Dopis o umiku je na voljo tukaj.
English: No new studies were submitted to support this application.
Slovenian: V podporo tej vlogi niso bile predložene nobene nove študije.
English: The application was withdrawn after ‘day 90'.
Slovenian: Družba je vlogo umaknila po 90. dnevu.
English: The full European Public Assessment Report for Qutenza can 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 Qutenza je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: The company presented further detailed analysis of the results of some of the studies that had been submitted at time the medicine was first approved.
Slovenian: Družba je predložila dodatno podrobno analizo izsledkov nekaterih študij, ki so bile predložene takrat, ko je bilo zdravilo prvič odobreno.