natgillin/translations-raw huggingface dataset:
Death (OS event) No. patients with event p=0.0024
Smrt (dogodek celokupnega preživetja): število bolnikov z dogodkom p = 0,0024
Table 16 Population Predicted PK Parameter Values at Steady State for Trastuzumab Intravenous Dosing Regimens in MBC, EBC and AGC Patients
Farmakokinetične vrednosti izpostavljenosti, predvidene za populacijo, v stanju dinamičnega ravnovesja za režima odmerjanja trastuzumaba v intravenski obliki pri bolnikih z MBC, EBC in AGC
Tumour cell cluster with a weak to moderate complete, basolateral or lateral membranous reactivity irrespective of percentage of tumour cells stained
Skupek tumorskih celic ima šibko do zmerno obarvane celotne, bazolateralne ali lateralne membrane, ne glede na odstotek obarvanih tumorskih celic.
Tumour cell cluster with a strong complete, basolateral or lateral membranous reactivity irrespective of percentage of tumour cells stained
Skupek tumorskih celic ima močno obarvane celotne, bazolateralne ali lateralne membrane, ne glede na odstotek obarvanih tumorskih celic.
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.
Običajno se pojavijo v zgodnejših fazah zdravljenja, torej med prvo, drugo in tretjo infuzijo, ter so manj pogoste pri naslednjih infuzijah.
Primary efficacy analysis DFS Hazard ratios (95% CI) p-value p<0.0001
Primarna analiza učinkovitosti Razmerje ogroženosti za preživetje brez ponovitve bolezni (95 % IZ) p-vrednost p < 0,0001
This yields a 20.6 mL solution for single-dose use, containing approximately 21 mg/mL trastuzumab, at a pH of approximately 6.0.
Rekonstitucija da 20,6 ml raztopine za enkratno uporabo, ki vsebuje približno 21 mg/ml trastuzumaba, s pH vrednostjo približno 6,0.
Doxorubicin and cyclophosphamide were administered concurrently as follows:
Odmerjanje doksorubicina in ciklofosfamida, ki so ju dajali sočasno, je bilo naslednje:
The reconstituted Trazimera solution contains 21 mg/mL of trastuzumab.
Pripravljena raztopina zdravila Trazimera vsebuje 21 mg/ml trastuzumaba.
- intravenous cyclophosphamide, at 600 mg/m 2 over 30 minutes, given every 3 weeks for
- ciklofosfamid intravensko - 600 mg/m 2 v 30 minutah, vsake 3 tedne, 4 cikle.
Biopsy specimen - staining pattern
Vzorci biopsijevidez preparata po barvanju
Hormone receptor positive patients must also have failed hormonal therapy, unless patients are unsuitable for these treatments.
Bolniki s hormonsko odvisnimi tumorji, pri katerih je bolezen napredovala po predhodnem hormonskem zdravljenju, razen če za takšno zdravljenje niso bili primerni;
Strong complete membrane staining is detected in >10% of the tumour cells.
Močno obarvanje celotne membrane pri > 10 % tumorskih celic.
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.
1) Uporabite sterilno injekcijsko brizgo in počasi injicirajte ustrezen volumen (naveden zgoraj)
This yields a 7.4 mL solution for single-dose use, containing approximately 21 mg/mL trastuzumab, at a pH of approximately 6.0.
Rekonstitucija da 7,4 ml raztopine za enkratno uporabo, ki vsebuje približno 21 mg/ml trastuzumaba, s pH vrednostjo približno 6,0.
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.
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.
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
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
Anaphylactic reaction
+anafilaktična reakcija neznana
• depression
• slabost
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
Študija WO16229: polnilni odmerek 8 mg/kg, čemur je sledil odmerek 6 mg/kg po 3-tedenskem režimu.
This yields a 20.6 mL solution for single-dose use, containing approximately 21 mg/mL trastuzumab.
Rekonstitucija da 20,6 ml raztopine za enkratno uporabo in vsebuje približno 21 mg/ml trastuzumaba.
• skin rashes
• kožni izpuščaji
- intravenous push doxorubicin, at 60 mg/m 2, given every 3 weeks for 4 cycles.
- doksorubicin v obliki intravenskega bolusa - 60 mg/m 2, vsake 3 tedne, 4 cikle;
A weak to moderate complete membrane staining is detected in >10% of the tumour cells.
Šibko do zmerno obarvanje celotne membrane pri > 10 % tumorskih celic.
Trazimera 150 mg powder for concentrate for solution for infusion Trazimera 420 mg powder for concentrate for solution for infusion trastuzumab
Trazimera 150 mg prašek za koncentrat za raztopino za infundiranje Trazimera 420 mg prašek za koncentrat za raztopino za infundiranje trastuzumab
Trazimera 150 mg powder for concentrate for solution for infusion Trazimera 420 mg powder for concentrate for solution for infusion
Trazimera 150 mg prašek za koncentrat za raztopino za infundiranje Trazimera 420 mg prašek za koncentrat za raztopino za infundiranje
Disease-free survival No. patients with event p=0.0003
Preživetje brez ponovitve bolezni: število bolnikov z dogodkom p = 0,0003
Trazimera 420 mg powder for concentrate for solution for infusion
Trazimera 420 mg prašek za koncentrat za raztopino za infundiranje
• abnormal thinking
• nenormalno razmišljanje bolezni ledvic
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.
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).
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).
Podaljšanje zdravljenja zgodnjega raka dojk na več kot 1 leto ni priporočljivo (glejte poglavje 5.1).
Reversibility of mild symptomatic and asymptomatic left ventricular dysfunction was demonstrated for 79.5% of patients.
Reverzibilnost blage simptomatske in asimptomatske disfunkcije levega prekata so dokazali pri
• haemorrhoids
• oglušelost
Anaphylactic shock
+anafilaktični šok neznana
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.
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.
Trazimera 420 mg powder for concentrate for solution for infusion trastuzumab
Trazimera 420 mg prašek za koncentrat za raztopino za infundiranje trastuzumab
Talk to your doctor, pharmacist or nurse before you are given Trazimera if:
Preden boste prejeli zdravilo Trazimera, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro, če:
Instructions for Reconstitution:
- Navodilo shranite.
Duration of Response, Median months
Trajanje odgovora, mediana (meseci) 4,8
Median duration of response (months) (95% CI) Median TTP (months) (95% CI)
Mediana TTP (meseci) (95 % IZ)
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
Povzetek rezultatov učinkovitosti iz skupne analize preskušanj NSABP B-31 in NCCTG N9831 v času končne analize preživetja brez ponovitve bolezni
- 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.
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).
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.
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).
Retinal haemorrhage
Rekonstituirana raztopina
• Paclitaxel 175 mg/m2 administered 3-weekly for 4 cycles,
temu je sledil - paklitaksel 175 mg/m2, enkrat na 3 tedne, 4 cikle;
The recommended maintenance dose of Trazimera at three-weekly intervals is 6 mg/kg body weight, beginning three weeks after the loading dose.
Priporočeni vzdrževalni odmerek zdravila Trazimera je 6 mg/kg telesne mase po 3 tednih od prejema polnilnega odmerka in nato v 3-tedenskih razmakih.
• jaundice
• driska
Cardiac failure (congestive)
• vnetje očesne veznice (konjunktivitis)
Hazard Ratio vs AC→P (95% CI) p-value
Razmerje ogroženosti v primerjavi z AC → P (95 % IZ) p-vrednost
Hazard Ratio versus AC→P (95% CI)
Razmerje ogroženosti v primerjavi z AC → P (95 % IZ)
Distant recurrence No. patients with event p<0.0001
Pojav oddaljenih metastaz: število bolnikov z dogodkom p < 0,0001
Long term follow-up efficacy analysis DFS Hazard rations (95% CI) p-value p<0.0001
Razmerje ogroženosti za preživetje brez ponovitve bolezni (95 % IZ) p-vrednost p < 0,0001
Trastuzumab washout period was assessed following q1w or q3w intravenous administration using the population PK model.
Obdobje izpiranja trastuzumaba so ocenjevali po intravenski aplikaciji zdravila enkrat na teden ali enkrat na 3 tedne s pomočjo populacijskega farmakokinetičnega modela.
No staining is observed or membrane staining is observed in <10% of the tumour cells
Obarvanje ni prisotno ali pa so obarvane membrane pri < 10 % vseh tumorskih celic v preparatu.
Do not administer as an intravenous push or bolus.
Zdravila se ne sme dajati kot hitro intravensko infuzijo ali bolus.
Trazimera and anthracyclines should not be given concurrently in combination in the adjuvant treatment setting.
Pri zdravljenju metastatskega raka dojk kombinacije zdravila Trazimera in antraciklinov ne smemo dajati sočasno.
Trazimera 150 mg powder for concentrate for solution for infusion
Trazimera 150 mg prašek za koncentrat za raztopino za infundiranje
Do not use Trazimera if you notice any particulate matter or discoloration prior to administration.
Če pred dajanjem opazite kakršnekoli delce ali obarvanje, ne uporabite zdravila Trazimera.
Not known
nezanesljivo
Hazard Ratio vs AC→D (95% CI) p-value
Razmerje ogroženosti v primerjavi z AC → D (95 % IZ) p-vrednost
Ear and labyrinth disorders Deafness
Ušesne bolezni, vključno z motnjami labirinta oglušelost občasni
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)
po operaciji so sledili - dodatni cikli trastuzumaba, adjuvantno (do zaključka prvega leta zdravljenja).
Trazimera 150 mg powder for concentrate for solution for infusion trastuzumab
Trazimera 150 mg prašek za koncentrat za raztopino za infundiranje trastuzumab
The recommended maintenance dose at three-weekly intervals is 6 mg/kg body weight, beginning three weeks after the loading dose.
Priporočeni vzdrževalni odmerek je 6 mg/kg telesne mase po 3 tednih od prejema polnilnega odmerka in nato v 3-tedenskih razmakih.
Hazard Ratio vs AC→D (95% CI)
Razmerje ogroženosti v primerjavi z AC → D (95 % IZ)
Table 5 Efficacy Results from the Non-Comparative Monotherapy and Combination Therapy Studies
Rezultati učinkovitosti monoterapije in kombiniranega zdravljenja iz študij brez primerjalne skupine
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.
Vaš zdravnik vam lahko zdravilo Trazimera predpiše za zdravljenje raka dojk in raka želodca, če:
In addition, terms reported in the post marketing setting are included in Table 1.
Poleg tega so v preglednici 1 navedeni tudi neželeni učinki o katerih so poročali v obdobju trženja zdravila.
Disease-free survival No. patients with event p<0.0001
Preživetje brez ponovitve bolezni: število bolnikov z dogodkom p < 0,0001
Death (OS event): No. patients with event p=0.014
Smrt (dogodek celokupnega preživetja): število bolnikov z dogodkom p = 0,014**
• muscle weakness
• mišična šibkost • zlatenica
• altered taste
• sprememba okušanja
• throat infections
• suhe oči okužbe grla
Mucosal inflammation
Bolezni živčevja
STATEMENT OF ACTIVE SUBSTANCE(S)
Analiza dolgoročnega spremljanja učinkovitosti**
Distant disease-free survival - No. patients with event - No. patients without event P-value versus Observation Hazard Ratio versus Observation
Preživetje brez pojava oddaljenih metastaz - št. bolnikov z dogodkom - št. bolnikov brez dogodka
• neck pain
• tesnoba vnetje dojk
Urinary tract infection
Shranjevanje zdravila Trazimera
Response rate (95% CI) Median duration of response (months) (range) Median TTP (months) (95% CI)
Mediana časa odgovora (meseci) (95 % IZ)
Hepatocellular injury
• bolečina v kosteh hemoroidi
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.
To vključuje zaviralec angiotenzinske konvertaze ali zaviralec angiotenzinskih receptorjev in antagonist receptorjev beta.
Refer to the SmPC for paclitaxel, docetaxel or aromatase inhibitor for information on dose reduction or delays.
Za zmanjšanje odmerka ali odložitev zdravljenja s paklitakselom, docetakselom ali zaviralcem aromataze glejte njihove Povzetke glavnih značilnosti zdravila.
A: doxorubicin; C: cyclophosphamide; P: paclitaxel; D: docetaxel; Carb: carboplatin; H: trastuzumab CI = confidence interval
A = doksorubicin; C = ciklofosfamid; P = paklitaksel; H = trastuzumab; IZ = interval zaupanja
The risk of neutropenia may be slightly increased when trastuzumab is administered with docetaxel following anthracycline therapy.
Če trastuzumab dajemo z docetakselom po zdravljenju z antraciklini, je lahko tveganje za nevtropenijo rahlo povečano.
• inflammation of the liver
• depresija vnetje jeter
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.
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.
Content Concentration
Stična ovojnina Vsebina (koncentracija)
4 single-dose kits (1 vial + 1 prefilled syringe + 1 vial connector + 2 needles)
4 enoodmerni seti (1 viala + 1 napolnjena injekcijska brizga + 1 povezovalec viale + 2 igli)
12 (3 x 4) singledose kits (1 vial + 1 pre-filled syringe + 1 vial connector + 2 needles) (multipack)
12 (3 x 4) enoodmernih setov (1 viala + 1 napolnjena injekcijska brizga + 1 povezovalec viale + 2 igli) (skupno pakiranje)
4 pre-filled pens + 1 needle
4 napolnjeni injekcijski peresniki + 1 igla
12 (3 x 4) prefilled pens + 3 needles (multipack)
12 (3 x 4) napolnjenih injekcijskih peresnikov + 3 igle (skupno pakiranje)
12 (3 x 4) prefilled pens (multipack)
12 (3 x 4) napolnjenih injekcijskih peresnikov (skupno pakiranje)
The withdrawal letter can be found here.
Dopis o umiku je na voljo tukaj.
No new studies were submitted to support this application.
V podporo tej vlogi niso bile predložene nobene nove študije.
The application was withdrawn after ‘day 90'.
Družba je vlogo umaknila po 90. dnevu.
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.
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.
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.
Družba je predložila dodatno podrobno analizo izsledkov nekaterih študij, ki so bile predložene takrat, ko je bilo zdravilo prvič odobreno.
This means that the CHMP had evaluated the documentation provided by the company and formulated lists of questions.
To pomeni, da je CHMP ocenil dokumentacijo, ki jo je predložila družba, in pripravil sezname vprašanj.
What consequences does this withdrawal have for patients in clinical trials or compassionate use programmes?
Kakšne so posledice umika za bolnike, ki sodelujejo v kliničnih preskušanjih ali programih sočutne uporabe?
This means that it stimulates the TRPV1 receptor, which is found in the nociceptors (pain receptors) in the skin.
To pomeni, da stimulira receptor TRPV1, ki ga najdemo v nociceptorjih (receptorjih za bolečino) v koži.
The analysis included data on 2,073 diabetic and non-diabetic patients from six studies.
V analizo so bili vključeni podatki iz šestih študij z 2 073 bolniki s sladkorno boleznijo ali brez nje.
It contains the active substance capsaicin (8%).
Vsebuje zdravilno učinkovino kapsaicin (8
In patients with diabetes, Qutenza is expected to work in the same way as it does in its existing indication.
Pri bolnikih s sladkorno boleznijo naj bi zdravilo Qutenza delovalo enako kot pri obstoječi indikaciji.
After the CHMP had assessed the company's responses to the questions, there were still some unresolved issues.
Potem ko je ocenil odgovore družbe na seznam vprašanj, so nekatera izmed njih še vedno ostala nerešena.
Qutenza contains high doses of capsaicin that are released quickly and overstimulate the TRPV1 receptors.
Zdravilo Qutenza vsebuje visoke odmerke kapsaicina, ki se hitro sproščajo in prekomerno stimulirajo receptorje TRPV1.
Overstimulating the receptors makes them become ‘desensitised' and no longer able to respond to the stimuli that normally cause pain in patients with peripheral neuropathic pain.
Receptorji s prekomernim stimuliranjem postanejo „desenzitirani“ in se ne morejo več odzivati na dražljaje, ki običajno povzročajo bolečino pri bolnikih s periferno nevropatsko bolečino.
Patients with diabetes, but especially those with diabetic neuropathic pain, could be put at risk as Qutenza may increase their chances of developing ulcers in the foot, which could lead to serious complications.
Bolniki s sladkorno boleznijo, zlasti tisti z nevropatskimi bolečinami zaradi sladkorne bolezni, so lahko ogroženi, saj lahko zdravilo Qutenza poveča možnost, da se pri njih pojavijo razjede na stopalih, kar bi lahko pripeljalo do hudih zapletov.
What is Qutenza?
Kaj je zdravilo Qutenza?
There are no consequences on the use of Qutenza in its authorised indication.
Umik nima posledic za uporabo zdravila Qutenza pri odobreni indikaciji.
Qutenza has been authorised in the EU since May 2009 and is already used to treat peripheral neuropathic pain (pain that is caused by damage to the nerves in the extremities) in adults who do not have diabetes.
Zdravilo Qutenza je v EU odobreno od maja 2009 in se že uporablja za zdravljenje periferne nevropatske bolečine (bolečine, ki jo povzroča poškodba živcev v okončinah) pri odraslih, ki nimajo sladkorne bolezni.
In its official letter, the company stated that its decision to withdraw the application was based on the CHMP's view that the data provided do not allow the Committee to conclude on a positive benefit-risk balance.
Družba je v uradnem dopisu navedla, da je podlaga za odločitev o umiku vloge mnenje odbora CHMP, da predloženi podatki ne omogočajo, da bi Odbor lahko sprejel pozitivno mnenje o razmerju med koristmi in tveganji.
It is used either alone or together with other painkillers.
Uporablja se lahko kot samostojno zdravilo ali v kombinaciji z drugimi zdravili za lajšanje bolečin.
The active substance in Qutenza, capsaicin, is a substance normally found in chilli peppers that is a ‘selective agonist' of the ‘transient receptor potential vanilloid 1' (TRPV1) receptor.
Zdravilna učinkovina v zdravilu Qutenza, kapsaicin, je snov, ki jo običajno najdemo v papriki čili in je selektivni agonist vaniloidnega receptorja 1 (TRPV1).
At the time of the initial approval, the evidence supporting the medicine's use in patients with diabetic neuropathic pain was considered insufficient and the CHMP excluded its use in all patients with diabetes.
Ob prvi odobritvi se je štelo, da so dokazi, ki podpirajo uporabo zdravila pri bolnikih z nevropatsko bolečino, ki je posledica sladkorne bolezni, nezadostni, zato je CHMP izključil njegovo uporabo pri bolnikih s sladkorno boleznijo.
Based on the review of the data and the company's response to the CHMP lists of questions, at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Qutenza could not have been approved to treat diabetic patients with non-diabetic peripheral neuropathic pain.
Na podlagi pregleda podatkov in odgovorov družbe na seznam vprašanj, ki jih je zastavil CHMP, je Odbor v času umika izrazil določene zadržke in je začasno menil, da zdravila Qutenza ni mogoče odobriti za zdravljenje sladkornih bolnikov s periferno nevropatsko bolečino, ki ni posledica sladkorne bolezni.
Therefore, at the time of the withdrawal, the CHMP was of the opinion that the benefits of Qutenza in diabetic patients did not outweigh its risks.
Zato je CHMP v času umika vloge menil, da koristi zdravila Qutenza pri sladkornih bolnikih ne odtehtajo z njim povezanih tveganj.
What was Qutenza expected to be used for?
Za kaj naj bi se zdravilo Qutenza uporabljalo?
On 14 March 2012, Astellas Pharma Europe B.V. officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a change to the marketing authorisation for Qutenza, which would have extended its use to patients with diabetes who have peripheral neuropathic pain not caused by their diabetes.
je 14. marca 2012 uradno obvestila Odbor za zdravila za uporabo v humani medicini (CHMP), da želi umakniti vlogo za spremembo dovoljenja za promet z zdravilom Qutenza, s katerim je želela njegovo uporabo razširiti na bolnike s sladkorno boleznijo, pri katerih se pojavi periferna nevropatska bolečina, ki ni posledica sladkorne bolezni.
The Committee was concerned that it would not be possible in clinical practice to distinguish patients with non-diabetic neuropathic pain from those with diabetic neuropathic pain.
Odbor je bil zaskrbljen, da v klinični praksi morda ne bi bilo mogoče razlikovati med bolniki z nevropatsko bolečino, ki ni posledica sladkorne bolezni, in tistimi z nevropatsko bolečino, ki je posledica sladkorne bolezni.