natgillin/translations-raw huggingface dataset:
§Клинична ремисия без кортикостероиди: Пациентите, използващи перорални кортикостероиди на изходно ниво, които са прекратили кортикостероидите от Седмица 6 и са били в клинична ремисия в Седмица 52.
§Corticosteroid-free clinical remission: Patients using oral corticosteroids at baseline who had discontinued corticosteroids beginning at Week 6 and were in clinical remission at Week 52.
§Клинична ремисия: пълен скор по Mayo ≤2 точки и без отделен субскор >1 точка
§Clinical remission: Complete Mayo score of ≤2 points and no individual subscore >1 point
§Не е правена оценка за статисти
§ Not evaluated for statistical significance
§Не е правена оценка за статистическа знач
§ Not evaluated for statistical significance
§Не е правена оценка за статистическа значимост поради последващо изследване за вторични крайни точки.
§ Not evaluated for statistical significance as a result of the sequential testing procedure for secondary end points
§Общо = 0 до 120 часа след започване на химиотерапия
§Overall = 0 to 120 hours post-initiation of chemotherapy.
§Общо: 0 до 120 часа след лечението с цисплатин.
§Overall: 0 to 120 hours post-cisplatin treatment.
§Общо: 0 до 120 часа след схема с антрациклин и циклофосфамид
§Overall: 0 to 120 hours after anthracycline and cyclophosphamide regimen
§Персистираща инфекция, открита в проби от две или повече последователни визити с интервал от 6 месеца (±1 месец прозорец между визитите).
§Persistent infection detected in samples from two or more consecutive visits 6 months (±1 month visit windows) apart.
§Полиморфизми в GT1a на NS5A: M28T/A, Q30E/H/R/G/K/L/D, L31M/V/F, H58D и Y93C/H/N.
§GT1a NS5A polymorphisms: M28T/A, Q30E/H/R/G/K/L/D, L31M/V/F, H58D, and Y93C/H/N.
§Присъща на класа продукти, съдържащи интерферон, вижте „Белодробна артериална хипертония”.
§ Class label for interferon products, see below Pulmonary arterial hypertension.
§няма статистическа значимост, поради това другите крайни точки не са били статистически тествани
§not statistically significant, the other endpoints were therefore not tested statistically
© EMEA 2008 Страница 2/2
© EMEA 2008 Page 2/2
© European Medicines Agency, "2015".
© European Medicines Agency, 2015.
© European Medicines Agency, 2010.
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© European Medicines Agency, 2010.
© European Medicines Agency, 2011.
© European Medicines Agency, 2010.
© European Medicines Agency,2010.
© European Medicines Agency, 2011.
© European Medicines Agency, 2014.
© European Medicines Agency, 2012.
© European Medicines Agency, 2013.
© European Medicines Agency, 2012.
© European Medicines Agency, 2016.
© European Medicines Agency, 2013.
An agency of the European Union
© European Medicines Agency, 2013.
© European Medicines Agency, 2012.
© European Medicines Agency, 2013.
© European Medicines Agency, 2016.
© European Medicines Agency, 2014.
An agency of the European Union
© European Medicines Agency, 2014.
© European Medicines Agency, 2011.
© European Medicines Agency, 2014.
© European Medicines Agency, 2012.
© European Medicines Agency, 2014.
© European Medicines Agency, 2013.
© European Medicines Agency, 2014.
© European Medicines Agency, 2015.
© European Medicines Agency, 2015.
© European Medicines Agency, 2014.
© European Medicines Agency, 2015.
© European Medicines Agency, 2016.
© European Medicines Agency, 2016.
© European Medicines Agency, 2014.
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© European Medicines Agency, 2015.
© Европейска агенция по лекарствата, 2015.
© European Medicines Agency, 2015.
ª Ако неутропенията е единствената токсичност на което и да е дозово ниво, добавете гранулоцит-колониoстимулиращ фактор (G-CSF) и поддържайте дозовото ниво на леналидомид
ª If neutropenia is the only toxicity at any dose level, add granulocyte colony stimulating factor (G-CSF) and maintain the dose level of lenalidomide
ª Ако ограничаващата дозата токсичност (ОДТ) възникне на > Ден 15 от даден цикъл, приложението на леналидомид ще бъде прекъснато най-малко през останалата част от текущия 28-дневен цикъл.
ª If Dose Limiting Toxicity (DLT) occurs on > Day15 of a cycle, lenalidomide dosing will be interrupted for at least the remainder of the current 28- day cycle.
ª Ако ограничаващата дозата токсичност (ОДТ) възникне на > Ден 15 от даден цикъл, приложението на леналидомид ще бъде прекъснато най-малко през останалата част от текущия 28-дневен цикъл.
ª If Dose Limiting Toxicity (DLT) occurs on > Day15 of a cycle, lenalidomide dosing will be interrupted for at least the remainder of the current 28-day cycle.
«ГОДЕН ДО».Срокът на годност отговаря на последния ден от посочения месец.
The expiry date refers to the last day of that month.
° Значимо свързани реакции при лечение с Betaferon на ВПМС, p < 0,05
° Significantly associated with Betaferon treatment for SPMS, p < 0.05
° Значимо свързани реакции при лечение с Extavia на ВПМС, p<0.05
° Significantly associated with Extavia treatment for SPMS, p <0.05
° От постмаркетинговия опит
° From post-marketing experience
° измерени с метода HI ≥ 40
° measured by HI assay ≥ 40
°° GMR на HI
°° GMRs of HI
°° Реакцията към инфузията/синдромът на освобождаване на цитокини включват редица различни термини във времевия прозорец, вижте “Описание на избрани нежелани реакции” по-долу.
°° Infusion reaction/cytokine release syndrome includes a range of different terms within a time window, see “Description of selected adverse reactions” below.
°° средни геометрични съотношения на HI
1.92 (1.64-2.25)
°° средни геометрични съотношения на HI
°° geometric mean ratios of HI
°° средни геометрични съотношения на HI
°° GMRs of HI
± 4 часа от приложението на
given ± 4 hours from
± SD пикова плазмена концентрация на лопинавир (Cmax) от 14,8 ± 3,5 g/ml, около 6 часа след приема.
lopinavir peak plasma concentration (Cmax) of 14.8 ± 3.5 g/ml, occurring approximately 6 hours after administration.
± На базата на нормално приближение
± Based on normal approximation.
± СО
 SD
± перорални глюкозопонижаващи лекарствени продукти2
± oral glucose-lowering medicinal products2
± перорални лекарствени продукти за понижаване на глюкозата2
± oral glucose-lowering medicinal products2
± стандартно отклонение) Популационните фармакокинетични параметри на ATryn, получени при същото проучване, са следните (средна стойност ± стандартно отклонение) :
Population pharmacokinetic parameters for ATryn derived from the same study revealed (mean ± SD):
²Критерии за цитогенетичен отговор:
2 Cytogenetic response criteria:
³Пълен цитогенетичен отговор, потвърден от второ цитогенетично изследване на костен мозък, извършено най-малко един месец след първоначалното изследване на костния мозък.
3 Complete cytogenetic response confirmed by a second bone marrow cytogenetic evaluation performed at least one month after the initial bone marrow study.
µg = микрограма
mcg = micrograms
¶ HbA1c (%) на 26-та седмица
¶ HbA1c (%) at week 26.
¶ HbA1c (%) на 26-та седмица.
¶ HbA1c (%) at week 26.
¶ Kliinilist tõhusust täheldati (< 5 patsiendil) ka järgmiste Candida liikide korral: C. guilliermondii, C. famata, C. lusitaniae, C. utilis, C. inconspicua ja C. dubliniensis.
¶ Clinical efficacy was also observed (< 5 patients) in the following Candida species: C. guilliermondii, C. famata, C. lusitaniae, C. utilis, C. inconspicua and C. dubliniensis.
¶ Tmax, време от нула до максимална плазмена концентрация
¶ Tmax, time from zero to maximum plasma concentration
¶ Всички отговори са частични отговори
¶ All responses were partial responses
¶ Най-малките средни квадрати са коригирани спрямо употребата на метформин при визита 1 (да/не), употребата на инсулин при визита 1 (предварително смесен срещу такъв, койот не е смесен предварително [интермедиерен или дългодействащ]) и изходна стойност.
¶ Least squares mean adjusted for metformin use at Visit 1 (yes/no), insulin use at Visit 1 (pre-mixed vs. non-pre-mixed [intermediate- or long-acting]), and baseline value.
¶ Най-малките средни квадрати са коригирани спрямо употребата на метформин при визита 1 (да/не), употребата на инсулин при визита 1 (предварително смесен срещу такъв, който не е смесен предварително [интермедиерен или дългодействащ]) и изходна стойност.
¶ Least squares mean adjusted for metformin use at Visit 1 (yes/no), insulin use at Visit 1 (pre-mixed vs. non-pre-mixed [intermediate- or long-acting]), and baseline value.
¶ Не е тествана значимостта.
¶ Significance not tested.
¶ Пациентите, при които има отговор, са проследени за минимум 12 месеца след началото на терапията
¶ Responders were followed for a minimum of 12 months after initiation of therapy
¶ Персистираща инфекция, открита в проби от три или повече последователни визити с интервал от 6 месеца (±1 месец прозорец между визитите).
¶Persistent infection detected in samples from three or more consecutive visits 6 months (±1 month visit windows) apart.
¶ напр. изгубен за проследяване, неспазване на изискванията, оттегляне на съгласието.
¶ e.g. lost to follow-up, non-compliance, withdrew consent.
¶HbA1c (%) на 26-та седмица
¶ HbA1c (%) at week 26.
¶n=157 за плацебо и n=158 за ведолизумаб
¶n=157 for placebo and n=158 for vedolizumab
¶Включва участници от C-EDGE TN, C-EDGE COINFECTION, C-EDGE TE и C-SCAPE.
¶Includes subjects from C-EDGE TN, C-EDGE COINFECTION, C-EDGE TE and C-SCAPE.
¶Включва участници от C-EDGE TN, C-EDGE COINFECTION, C-EDGE TE, C-WORTHY и C-SURFER.
¶Includes subjects from C-EDGE TN, C-EDGE COINFECTION, C-EDGE TE, C-WORTHY and C-SURFER.
¶Оздравяване на лигавицата: Ендоскопски субскор по Mayo ≤1 точка
¶Mucosal healing: Mayo endoscopic subscore of ≤1 point
¶Полиморфизъм на NS3, определен като субституция на аминокиселини на позиции 36, 54, 55, 56, 80,
¶NS3 polymorphisms considered were any amino acid substitution at positions 36, 54, 55, 56, 80, 107, 122,
¶Траен клиничен отговор: клиничен отговор в Седмици 6 и 52
¶Durable clinical response: Clinical response at Weeks 6 and 52
¶Трайна клинична ремисия: Клинична ремисия ≥ 80% от визитите по проучването, включително последната визита (Седмица 52)
¶Durable clinical remission: Clinical remission at ≥80% of study visits including final visit (Week 52)
¹Критерии за хематологичен отговор (всички отговори трябва се потвърдят след
1 Haematological response criteria (all responses to be confirmed after >4weeks):
½ таблеткa 1 таблетка
1 tablet
½ таблеткa, 1 таблетка
1 tablet
½ таблетка
½ 5 tablet
À Av. da Siderurgia Nacional 4745-457 S. Mamede do Coronado - Португалия Тел.: +351 22 986 61 00
À Av. da Siderurgia Nacional 4745-457 S. Mamede do Coronado - Portugal tel: +351 22 986 61 00
À Av. da Siderurgia Nacional 4745-457 S. Mamede do Coronado Португалия
À Av. da Siderurgia Nacional 4745-457 S. Mamede do Coronado Portugal
À Av. da Siderurgia Nacional 4745-457 S. Mamede do Coronado Португалия (само за външната опаковка)
À Av. da Siderurgia Nacional 4745-457 S. Mamede do Coronado Portugal (only for outer packaging)
Äggläggning:
Lay:
Äldre
Elderly
Äldre patienter (≥65 år)
Elderly patients (≥65 years)
Äldre: Data saknas för säkerhet och effekt hos patienter över 65 år.
Elderly: There are no safety and efficacy data available in patients over the age of 65 years.
Äldre: Emtriva har inte studerats hos patienter över 65 år.
Elderly: Emtriva has not been studied in patients over the age of 65.
Ändra inte dosen såvida inte läkaren säger åt dig att göra det.
Do not change the dose unless your doctor tells you to.
Äppelarom (innehållande butylhydroxianisol [E320]) Krospovidon
Apple flavour (containing butylated hydroxyanisole (E320)) Crospovidone
Ärge kasutage lahjendatud infusioonilahust, mis on hägune või milles esineb sade.
Only a trained healthcare professional who has read the complete directions properly can prepare this medicine for use.
Ärge kasutage lahust, mis on hägune või milles on sade.
Do not use if the solution is cloudy or has precipitated.
Även för behandling av candidiasis.
Also for the treatment of candidiasis.
Även om Cerenia har visat sig vara effektivt vid både behandling och förebyggande behandling av kräkning som orsakats av kemoterapi är det mer effektivt om det används i förebyggande syfte.
Although Cerenia has been demonstrated to be effective in both the treatment and prevention of emesis induced by chemotherapy, it was found more efficacious if used preventively.
Även om det finns begränsade kliniska data om användning av Emtriva under graviditet, används det vanligen inte om det inte är absolut nödvändigt.
Although there are limited clinical data on the use of Emtriva in pregnant women, it is not usually used unless absolutely necessary.
Även om det är sällsynt kan krampanfall inträffa hos hundar som behandlas med Reconcile.
Though rare, seizures may occur in dogs treated with Reconcile.
Ålder
Age
Åldern verkar ha en inverkan på maropitants farmakokinetik hos katter vilket innefattar högre clearance hos kattungar än hos vuxna katter.
There appears to be an age-related effect on the pharmacokinetics of maropitant in cats with kittens having higher clearance than adults.
Æske indeholdende 1 eller 10 hætteglas med 20, 50, 100, 200 eller 500 ml.
Cardboard box with 1 or 10 vials of 20, 50, 100, 200 or 500 ml.
Æske med 1 eller 10 hætteglas med 100 ml.
Cardboard box with 1 or 10 vials of 100 ml.
Æske med 1 eller 10 hætteglas med 20 ml.
Cardboard box with 1 or 10 vials of 20 ml.
Æske med 1 eller 10 hætteglas med 200 ml.
Cardboard box with 1 or 10 vials of 200 ml.
Æske med 1 eller 10 hætteglas med 50 ml.
Cardboard box with 1 or 10 vials of 50 ml.
Æske med 1 eller 10 hætteglas med 500 ml.
Cardboard box with 1 or 10 vials of 500 ml.
Æterna Zentaris GmbH, Weismüllerstraße 50, D-60314 Frankfurt, Германия или
Æterna Zentaris GmbH, Weismüllerstraße 50, D-60314 Frankfurt, Germany or
Én dosis på 2 ml indeholder:
Each dose of 2 ml contains:
Én dosis på 2 ml indeholder:
One dose of 2 ml contains:
Ísland
Italia
Ísland
Malta
Ísland
Nederland
Ísland
Polska
Ísland
Slovenija
Ísland
Suomi/Finland
Ísland
Ísland Roche a/s
Ísland
Ελλάδα
Ísland
Ελλάδα Polska
Ísland Icepharma hf, Lynghálsi 13,
Dechra Veterinary Products BV Pettelaarpark 38
Ísland Meda AB Box 906
Slovenija
Ísland Vistor hf.
Ísland Vistor
Ö sterreich
Österreich
Ökad
Increased
Ökning av QT-intervallet med cirka 10 % har iakttagits vid EKG i en studie på friska beagle-hundar efter oral administrering av 8 mg/kg, men en ökning av denna storlek torde inte vara kliniskt signifikant.
Increases of approximately 10% in the QT interval of the ECG were observed in a study on healthy beagle dogs administered 8 mg/kg orally; however, such an increase is unlikely to be of clinical significance.
Öppnad flaska: 45 dagar.
After first opening: 45 days.
Öppnad flaska: förvaras vid högst 25°C.
After opening: do not store above 25ºC.
Öppnad flaska: förvaras vid högst 25°C.
After opening: Do not store above 25C.
Öppnad förpackning användas inom 28 dagar.
Once broached, use within 28 days.
Öppnad förpackning ska användas inom 28 dagar.
Once opened, use within 28 days.
Öppnad förpackning ska användas inom 3 månader.
Once opened use within 3 months.
Öppnad förpackning skall användas inom 6 månader.
Once opened use within 6 months.
Öppnad:
Opened:
Österreich
France
Österreich
Hrvatska
Österreich
Ireland
Österreich
Italia
Österreich
Latvija
Österreich
Lietuva
Österreich
Polska
Österreich
România
Österreich AbbVie GmbH Tel: +43 1 20589-0
Tel.: +36 1 455 8600
Österreich AbbVie GmbH Tel: +43 1 20589-0
Tel.:+36 1 455 8600
Österreich AbbVie GmbH Tel: +43 1 20589-0
Tel: +351 (0)21 1908400
Österreich AbbVie GmbH Tel: +43 1 20589-0
Tel: +385 (0)1 5625 501
Österreich medac GmbH
Ö sterreich medac GmbH
Österreich ratiopharm Arzneimittel Vertriebs-GmbH Tel: +(43/1/97007-0
Österreich ratiopharm Arzneimittel Vertriebs-GmbH Tel: +43/1/97007-0
Österreich ratiopharm Arzneimittel Vertriebs-GmbH Tel: +43 1 97007 0
Österreich ratiopharm Arzneimittel Vertriebs-GmbH Tel: +43 1 97007-0
Österreich sanofi-aventis GmbH Tel: + 43 1 80 185 - 0
Österreich sanofi-aventis GmbH Tel: + 43 1 80 185 – 0
Överdosering
Overdose
Överdosering (symptom, akuta åtgärder, motgift) (om nödvändigt)
Overdose (symptoms, emergency procedures, antidotes), if necessary
Överdosering (symptom, akuta åtgärder, motgift) om nödvändigt
Overdose (symptoms, emergency procedures, antidotes), if necessary
Överdosering (symptom, akuta åtgärder, motgift), om nödvändigt
Overdose (symptoms, emergency procedures, antidotes), if necessary
Överdosering (symtom, akuta åtgärder, motgift), om nödvändigt
Overdose (symptoms, emergency procedures, antidotes), if necessary
Överdosering med ceftazidim/avibaktam kan orsaka neurologiska sequelae såsom encefalopati, konvulsioner och koma på grund av ceftazidim-komponenten.
Overdose with ceftazidime/avibactam can lead to neurological sequelae including encephalopathy, convulsions and coma, due to the ceftazidime component.
Överför omedelbart all den resulterande lösningen (cirka 12,0 ml) till en infusionspåse.
Transfer the entire contents (approximately 12.0 mL) of the resultant solution to an infusion bag immediately.
Överföring av hiv
Transmission of HIV
Överkänslighet mot de aktiva substanserna eller mot något hjälpämne som anges i avsnitt 6.1. Överkänslighet mot någon antibiotika av typen cefalosporiner.
Hypersensitivity to the active substances or to any of the excipients listed in section 6.1. Hypersensitivity to any cephalosporin antibacterial agent.
Överkänslighet mot den aktiva substansen eller mot något hjälpämne som anges i avsnitt 6.1.
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Överkänslighet mot den aktiva substansen eller mot något hjälpämne som anges i avsnitt 6.1. Överkänslighet mot antibiotika i klassen cefalosporiner.
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Hypersensitivity to the cephalosporin class of antibacterials.
Överkänslighetsreaktioner
Hypersensitivity reactions
Överväg att avbryta behandlingen med Zavicefta och administrera specifik behandling för Clostridium difficile.
Discontinuation of therapy with Zavicefta and the administration of specific treatment for Clostridium difficile should be considered.
Övriga bestämmels er
Other provisions
Övriga biverkningar
Other side effects
Övriga eventuella biverkningar
Other possible effects
Övriga innehållsämnen är:
The other ingredients are:
Övriga innehållsämnen är: sockervaddsarom, dinatriumedetat, saltsyra, metylparahydroxibensoat (E218), propylenglykol, propylparahydroxibensoat (E216), natriumhydroxid, natriumdivätefosfatmonohydrat, para-orange (E110), renat vatten, xylitol (E967).
The other ingredients are: cotton candy flavouring, disodium edetate, hydrochloric acid, methyl parahydroxybenzoate (E218), propylene glycol, propyl parahydroxybenzoate (E216), sodium hydroxide, sodium phosphate monobasic hydrate, sunset yellow (E110), purified water, xylitol (E967).
ÖVRIGA VILLKOR OCH KRAV FÖR GODKÄNNANDET FÖR FÖRSÄLJNING
OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION
ÖVRIGT
OTHER
Övrigt innehållsämne är natriumkarbonat (vattenfri).
The other ingredient is sodium carbonate (anhydrous).
Údaje o farmakokinetice atazanaviru a kobicistatu v kombinaci u pediatrických pacientů nejsou k dispozici.
No data are available on the pharmacokinetics of atazanavir and cobicistat in combination in paediatric patients.
Údaje o podávání guanfacinu těhotným ženám jsou omezené nebo nejsou k dispozici.
There are no or limited amount of data from the use of guanfacine in pregnant women.
Údaje o použití přípravku EVOTAZ u těhotných žen nejsou k dispozici.
There are no data from the use of EVOTAZ in pregnant women.
Údaje o vlivu použití guanfacinu u člověka na fertilitu jsou omezené nebo nejsou k dispozici.
There are no or limited amount of data regarding effect on fertility from the use of guanfacine in humans.
Údaje o účinnosti sú založené prevažne na pacientoch s liposarkómom a leiomyosarkómom.
Efficacy data are based mainly on liposarcoma and leiomyosarcoma patients.
Údaje týkající se účinku kobicistatu na fertilitu u lidí nejsou k dispozici.
No human data on the effect of cobicistat on fertility are available.
ÚDAJE UVÁDÉNÉ NA VNÉJŠÍM OBALU
PARTICULARS TO APPEAR ON THE OUTER PACKAGING
ÚDAJE UVÁDÉNÉ NA VNÉJŠÍM OBALU PAPÍROVÁ SKLÁDAČKA
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON
ÚDAJE UVÁDĚNÉ NA VNITŘNÍM OBALU
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING
ÚDAJE UVÁDĚNÉ NA VNĚJŠÍM OBALU
PARTICULARS TO APPEAR ON THE OUTER PACKAGING
ÚDAJE UVÁDĚNÉ NA VNĚJŠÍM OBALU A VNITŘNÍM OBALU
PARTICULARS TO APPEAR ON THE OUTER PACKAGING
Údaje ze studií na lidských jaterních mikrozómech ukázaly, že karboxylovaný metabolit clopidogrelu může inhibovat aktivitu cytochromu P450 2C9.
Data from studies with human liver microsomes indicated that the carboxylic acid metabolite of clopidogrel could inhibit the activity of Cytochrome P450 2C9.
Údaje získané ze středně velkého souboru těhotných žen (mezi 300-1 000 ukončených těhotenství) nenaznačují malformační toxicitu atazanaviru.
A moderate amount of data in pregnant women (between 300-1000 pregnancy outcomes) indicates no malformative toxicity of atazanavir.
ÚDAJE, KTORÉ MAJÚ BYŤ UVEDENÉ NA VONKAJŠOM OBALE
PARTICULARS TO APPEAR ON THE OUTER PACKAGING
Úmrtnosť pri prítomnosti poškodenia pečene sa vyskytla u menej než 1 % pacientov liečených oboma režimami.
Mortality in the presence of hepatic injury occurred in less than 1% of patients in both regimens.
Únava
Fatigue
Únava (stupeň 3-4 = 9 %), asténia (stupeň 3-4 = 1 %)
Fatigue (Grade 3-4 = 9%), Asthenia (Grade 3-4 = 1%)
Úplný seznam pomocných látek, viz bod 6.1.
For the full list of excipients, see section 6.1.
Úplný zoznam pomocných látok, pozri časť 6.1.
For the full list of excipients, see section 6.1
Úplný zoznam pomocných látok, pozri časť 6.1.
For the full list of excipients, see section 6.1.
Úpravy dávkovania počas liečby
Dose adjustments during treatment
Út St Čt Pá So Ne
Tue Wed Thu Fri Sat Sun
Úvodná dávka
Starting dose
Úzkost
Anxiety
Úzkost
Anxiety.
Účinek kobicistatu na farmakokinetiku atazanaviru
Effect of cobicistat on atazanavir pharmacokinetics
Účinek na výšku, tělesná hmotnost a BMI
Effects on height, weight and body Mass index (BMI)
Účinek orlistatu u osob s poruchou funkce jater a/nebo ledvin nebyl sledován (viz bod 4.4).
The effect of orlistat in individuals with hepatic and/or renal impairment has not been studied (see section 4.4).
Účinky iných látok na trabektedín
Effects of other substances on trabectedin
Účinky na játra
Effects on the liver
Účinky na odhadovanou clearance kreatininu
Effects on estimated creatinine clearance
Účinky na srážlivost krve u lidí, kteří užívají warfarin nebo jiné léky na ředění krve (antikoagulancia).
Effects on blood clotting in people taking warfarin or other blood-thinning (anti-coagulant) medicines
Účinky na srážlivost krve u lidí, kteří užívají warfarin nebo jiné léky na ředění krve (antikoagulancia).
Effects on blood clotting in people taking warfarin or other blood-thinning (anti-coagulant) medicines.
Účinky na výšku, hmotnost a Body Mass Index (BMI)
Effects on height, weight and Body Mass index (BMI)
Účinky nejsou známy
Effects unknown
Účinky přípravku EVOTAZ na fertilitu u lidí nebyly studovány.
The effect of EVOTAZ on fertility in humans has not been studied.
Účinky souběžného podávání přípravku EVOTAZ na progestin a estrogen nejsou známy.
Effects of co-administration of EVOTAZ on progestin and estrogen are unknown.
Účinky trabektedínu na kardiovaskulárnu a dýchaciu funkciu boli skúmané in vivo (anestézované opice Cynomolgus).
The effects of trabectedin on cardiovascular and respiratory function have been investigated in vivo (anesthetised Cynomolgus monkeys).
Účinky zjištěné při vyšetření krve
Effects seen in blood tests
Účinnosť a bezpečnosť trabektedínu v liečbe sarkómu mäkkého tkaniva vychádza z randomizovanej skúšky u pacientov s miestne pokročilým alebo metastatickým lipo- alebo leiomyosarkómom, ktorých choroba pokročila alebo sa znovu zhoršila po liečbe prinajmenšom antracyklínmi a ifosfamidom.
The efficacy and safety of trabectedin in soft tissue sarcoma is based in a randomised trial in patients with locally advanced or metastatic lipo- or leiomyosarcoma, whose disease had progressed or relapsed after treatment with at least anthracyclines and ifosfamide.