natgillin/translations-raw huggingface dataset:
Tрябва също незабавно да информирате Вашия лекар, ако развиете заболяване, известно като тромботична тромбоцитопенична пурпура или TTP, което включва висока температура и образуване на синини по кожата, които могат да се проявят като малки червени точки, със или без необяснима прекомерна уморяемост, обърканост, пожълтяване на кожата или очите (жълтеница) (вижте точка 4).
You should also tell your doctor immediately if you develop a medical condition known as Thrombotic Thrombocytopenic Purpura or TTP that includes fever and bruising under the skin that may appear as red pinpoint dots, with or without unexplained extreme tiredness, confusion, yellowing of the skin or eyes (jaundice) (see section 4).
Tрябва също незабавно да информирате Вашия лекар, ако развиете състояние (известно още като Тромботична Тромбоцитопенична Пурпура или ТТП), което включва повишена температура и синини по кожата, които могат да се проявят като малки червени точки, със или без необяснима прекомерна уморяемост, объркване, пожълтяване на кожата или очите (жълтеница) (вижте точка 4 “Възможни нежелани реакции”).
You should also tell your doctor immediately if you develop a medical condition (also known as Thrombotic Thrombocytopenic Purpura or TTP) that includes fever and bruising under the skin that may appear as red pinpoint dots, with or without unexplained extreme tiredness, confusion, yellowing of the skin or eyes (jaundice) (see section 4 ‘Possible side effects’).
Tрябва също незабавно да информирате Вашия лекар, ако развиете състояние (известно още като тромботична тромбоцитопенична пурпура или ТТП), което включва повишена температура и подкожни синини, които могат да се проявят като малки червени точки, със или без необяснима прекомерна уморяемост, объркване, пожълтяване на кожата или очите (жълтеница) (вижте точка 4 “ Възможни нежелани реакции”).
You should also tell your doctor immediately if you develop a medical condition (also known as Thrombotic Thrombocytopenic Purpura or TTP) that includes fever and bruising under the skin that may appear as red pinpoint dots, with or without unexplained extreme tiredness, confusion, yellowing of the skin or eyes (jaundice) (see section 4 ‘Possible side effects’).
Tрябва също незабавно да информирате Вашия лекар, ако развиете състояние (известно още като тромботична тромбоцитопенична пурпура или ТТП), което включва повишена температура и подкожни синини, които могат да се проявят като малки червени точки, със или без необяснима прекомерна уморяемост, объркване, пожълтяване на кожата или очите (жълтеница) (вижте точка 4 “Възможни нежелани реакции”).
You should also tell your doctor immediately if you develop a medical condition (also known as Thrombotic Thrombocytopenic Purpura or TTP) that includes fever and bruising under the skin that may appear as red pinpoint dots, with or without unexplained extreme tiredness, confusion, yellowing of the skin or eyes (jaundice) (see section 4 ‘POSSIBLE SIDE EFFECTS’).
Tрябва също незабавно да информирате Вашия лекар, ако развиете състояние (известно още като тромботична тромбоцитопенична пурпура или ТТП), което включва повишена температура и синини по кожата, които могат да се прояват като малки червени точки по кожата със или без необяснима прекомерна уморяемост, объркване, пожълтяване на кожата или очите (жълтеница) (вижте точка 4 “Възможни нежелани реакции”).
You should also tell your doctor immediately if you develop a medical condition (also known as Thrombotic Thrombocytopenic Purpura or TTP) that includes fever and bruising under the skin that may appear as red pinpoint dots, with or without unexplained extreme tiredness, confusion, yellowing of the skin or eyes (jaundice) (see section 4 ‘Possible side effects’).
Tрябва също незабавно да информирате Вашия лекар, ако развиете състояние (известно още като тромботична тромбоцитопенична пурпура или ТТП), което включва повишена температура и синини по кожата, които могат да се проявят като малки червени точки, със или без необяснима прекомерна уморяемост, объркване, пожълтяване на кожата или очите (жълтеница) (вж точка 4 “ВЪЗМОЖНИ НЕЖЕЛАНИ РЕАКЦИИ”).
You should also tell your doctor immediately if you develop a medical condition (also known as Thrombotic Thrombocytopenic Purpura or TTP) that includes fever and bruising under the skin that may appear as red pinpoint dots, with or without unexplained extreme tiredness, confusion, yellowing of the skin or eyes (jaundice) (see section 4 ‘POSSIBLE SIDE EFFECTS’).
Tрябва също незабавно да информирате Вашия лекар, ако развиете състояние (известно още като тромботична тромбоцитопенична пурпура или ТТП), което включва повишена температура и синини по кожата, които могат да се проявят като малки червени точки, със или без необяснима прекомерна уморяемост, объркване, пожълтяване на кожата или очите (жълтеница) (вж точка 4“Възможни нежелани реакции”).
You should also tell your doctor immediately if you develop a medical condition (also known as Thrombotic Thrombocytopenic Purpura or TTP) that includes fever and bruising under the skin that may appear as red pinpoint dots, with or without unexplained extreme tiredness, confusion, yellowing of the skin or eyes (jaundice) (see section 4 ‘Possible side effects’).
Tрябва също незабавно да информирате Вашия лекар, ако развиете състояние (известно още като тромботична тромбоцитопенична пурпура или ТТП), което включва повишена температура и синини по кожата, които могат да се проявят като малки червени точки, със или без необяснима прекомерна уморяемост, объркване, пожълтяване на кожата или очите (жълтеница) (вижте точка 4 “ВЪЗМОЖНИ НЕЖЕЛАНИ РЕАКЦИИ”).
You should also tell your doctor immediately if you develop a medical condition (also known as Thrombotic Thrombocytopenic Purpura or TTP) that includes fever and bruising under the skin that may appear as red pinpoint dots, with or without unexplained extreme tiredness, confusion, yellowing of the skin or eyes (jaundice) (see section 4 ‘POSSIBLE SIDE EFFECTS’).
Tрябва също незабавно да информирате Вашия лекар, ако развиете състояние (известно още като тромботична тромбоцитопенична пурпура или ТТП), което включва повишена температура и синини по кожата, които могат да се проявят като малки червени точки, със или без необяснима прекомерна уморяемост, объркване, пожълтяване на кожата или очите (жълтеница) (вижте точка 4).
You should also tell your doctor immediately if you develop a medical condition (also known as Thrombotic Thrombocytopenic Purpura or TTP) that includes fever and bruising under the skin that may appear as red pinpoint dots, with or without unexplained extreme tiredness, confusion, yellowing of the skin or eyes (jaundice) (see section 4).
Tрябва също незабавно да информирате Вашия лекар, ако развиете състояние (известно още като тромботична тромбоцитопенична пурпура или ТТП), което включва повишена температура и синини по кожата, които могат да се проявят като малки червени точки, със или без необяснима прекомерна уморяемост, объркване, пожълтяване на кожата или очите (жълтеница) (вижте точка 4“ Възможни нежелани реакции”).
You should also tell your doctor immediately if you develop a medical condition (also known as Thrombotic Thrombocytopenic Purpura or TTP) that includes fever and bruising under the skin that may appear as red pinpoint dots, with or without unexplained extreme tiredness, confusion, yellowing of the skin or eyes (jaundice) (see section 4 ‘Possible side effects’).
Tрябва също незабавно да информирате Вашия лекар, ако развиете състояние (известно още като тромботична тромбоцитопенична пурпура или ТТП), което включва повишена температура и синини по кожата, които могат да се проявят като малки червени точки, със или без необяснима прекомерна уморяемост, объркване, пожълтяване на кожата или очите (жълтеница) (вижтеточка 4 “Възможни нежелани реакции”).
You should also tell your doctor immediately if you develop a medical condition (also known as Thrombotic Thrombocytopenic Purpura or TTP) that includes fever and bruising under the skin that may appear as red pinpoint dots, with or without unexplained extreme tiredness, confusion, yellowing of the skin or eyes (jaundice) (see section 4 ‘Possible side effects’).
Tрябва също незабавно да информирате Вашия лекар, ако развиете състояние , което включва повишена температура и синини по кожата, които могат да се проявят като малки червени точки, със или без необяснима прекомерна уморяемост, объркване, пожълтяване на кожата или очите (жълтеница) (вижте “ВЪЗМОЖНИ НЕЖЕЛАНИ РЕАКЦИИ”).
You should also tell your doctor immediately if you develop a medical condition (also known as Thrombotic Thrombocytopenic Purpura or TTP) that includes fever and bruising under the skin that may appear as red pinpoint dots, with or without unexplained extreme tiredness, confusion, yellowing of the skin or eyes (jaundice) (see section 4 ‘POSSIBLE SIDE EFFECTS’).
Tъй като панкреатичните ензими не се абсорбират от стомашно-чревния тракт, след перорално приложение на панкреасен прах не се очаква системна токсичност.
However as pancreatic enzymes are not absorbed from the gastrointestinal tract, no systemic toxicity is expected following oral administration of pancreas powder.
Tя съдържа активното вещество лефлуномид.
It contains the active substance leflunomide.
T +49 (0)89 3803772-0
T: +49 (0)89 3803772-0
U 2 % pacientů, léčených atazanavirem došlo k současnému zvýšení ALT/AST 3.-4. stupně a zvýšení celkového bilirubinu 3.- 4. stupně.
Two percent of patients treated with atazanavir experienced concurrent Grade 3-4 ALT/AST and Grade 3-4 total bilirubin elevations.
U dolutegraviru se nepředpokládá, že ovlivňuje farmakokinetiku přípravku EVOTAZ.
Dolutegravir is not expected to affect the pharmacokinetics of EVOTAZ.
U dospělých se v porovnání s užitím nalačno zvýšila střední expozice guanfacinu (Cmax ~ 75 % a AUC ~ 40 %) při užití přípravku Intuniv společně s jídlem s vysokým obsahem tuku (viz bod 4.2).
In adults, the mean exposure of guanfacine increased (Cmax ~75% and AUC ~40%) when Intuniv was taken together with a high fat meal, compared to intake in the fasted state (see section 4.2).
U dětských pacientů byl hlášen asymptomatický atrioventrikulární blok I. stupně (23 %) a II. stupně (1 %).
Both asymptomatic first-degree (23%) and second-degree (1%) atrioventricular block were reported in paediatric patients.
U dětí a dospívajících léčených přípravkem Intuniv může dojít k nárůstu BMI.
Children and adolescents treated with Intuniv may show an increase in their BMI.
U dětí s ADHD mladších než 6 let nebyly provedeny žádné studie s přípravkem Intuniv.
There have been no studies performed in children with ADHD under the age of 6 years with Intuniv.
U guanfacinu bylo rovněž prokázáno významné zlepšení při učení a fungování ve škole i v rodině (měřeno pomocí skóre WFIRS-P, Weiss Functional Impairment Rating Scale—Parent Report).
Guanfacine also showed significant improvement in learning, school and family functioning as measured with the (WFIRS-P score).
U kobicistatu se nepředpokládá, že indukuje CYP3A4 nebo P-gp.
Cobicistat is not expected to induce CYP3A4 or P-gp.
U kobicistatu se nepředpokládá, že inhibuje CYP1A2, CYP2B6, CYP2C8, CYP2C9 nebo CYP2C19.
Cobicistat is not expected to inhibit CYP1A2, CYP2B6, CYP2C8, CYP2C9 or CYP2C19.
U lidí s hemofilií A nebo B se může objevit zvýšené krvácení.
People who already have type A or B haemophilia may notice increased bleeding.
U lipidů existuje v některých případech důkaz účinku léčby, zatímco u přírůstku tělesné hmotnosti není významný průkaz spojení s touto léčbou.
For lipids, there is in some cases evidence for a treatment effect, while for weight gain there is no strong evidence relating this to any particular treatment.
U léčivých přípravků, které jsou metabolizovány prostřednictvím CYP3A, CYP2C8, CYP2D6 a/nebo UGT1A1, se při souběžném podávání s přípravkem EVOTAZ očekávají zvýšené plazmatické koncentrace.
Increased plasma concentrations of medicinal products that are metabolised by CYP3A, CYP2C8, CYP2D6 and/or UGT1A1 are expected when co-administered with EVOTAZ.
U maraviroku se nepředpokládá, že má vliv na koncentrace atazanaviru a kobicistatu.
Maraviroc is not expected to have an impact on concentrations of atazanavir and cobicistat.
U myších samců a potkanů nebyly žádné známky kancerogenního působení nalezeny.
There were no tumorigenic findings in male mice or in rats.
U některých pacientů s HIV infekcí (AIDS) v pokročilém stadiu, kteří dříve prodělali oportunní infekci (infekci provázející primární onemocnění), se mohou brzy po zahájení anti-HIV léčby vyskytnout známky a příznaky zánětu z předchozích infekcí.
In some patients with advanced HIV infection (AIDS) and a history of opportunistic infection, signs and symptoms of inflammation from previous infections may occur soon after anti-HIV treatment is started.
U obou dávek byl pozorován zdánlivý nárůst středního QTc intervalu.
An apparent increase in mean QTc was observed for both doses.
U obou ramen léčby byl vyhodnocen podíl virologické odpovědi a virologická odpověď byla definována jako dosažení nedetekovatelné virové zátěže (< 50 HIV-1 RNA kopií/ml).
Virologic response rate was evaluated in both treatment arms and virologic response was defined as achieving an undetectable viral load (<50 HIV-1 RNA copies/ml).
U pacientov liečených viacnásobnými cyklami sa nepozorovali žiadne kumulatívne toxicity.
No cumulative toxicities have been observed in patients treated with multiple cycles.
U pacientov s PFI  6 mesiacov (65 % v skupine s Yondelis+PLD a 63 % v skupine s PLD) bola stredná hodnota PFS 9,7 mesiacov v skupine Yondelis+PLD v porovnaní so 7,2 mesiacmi skupine s PLD monoterapiou (HR=0,66; CI: 0,52-0,85).
In patients with PFI  6 months (65% in Yondelis+PLD and 63% in PLD arm), median PFS was 9.7 months in the Yondelis+PLD arm compared with 7.2 months in the PLD monotherapy arm (HR=0.66, CI: 0.52-0.85).
U pacientov, ktorí dostávali trabektedín, bola hlásená únava a/alebo asténia.
However, fatigue and/or asthenia have been reported in patients receiving trabectedin.
U pacientů léčených atazanavirem byla hlášena cholelitiáza (viz bod 4.8).
Cholelithiasis has been reported in patients receiving atazanavir (see section 4.8).
U pacientů léčených atazanavirem byla hlášena nefrolitiáza (viz bod 4.8).
Nephrolithiasis has been reported in patients receiving atazanavir (see section 4.8).
U pacientů léčených atazanavirem se objevily případy reverzibilního zvýšení nepřímého (nekonjugovaného) bilirubinu souvisejícího s inhibicí UDP-glukuronosyltransferázy (UGT) (viz bod 4.8).
Reversible elevations in indirect (unconjugated) bilirubin related to inhibition of UDP-glucuronosyl transferase (UGT) have occurred in patients receiving atazanavir (see section 4.8).
U pacientů na hemodialýze se přípravek EVOTAZ nedoporučuje (viz body 4.2 a 5.2).
EVOTAZ is not recommended in patients undergoing haemodialysis (see sections 4.2 and 5.2).
U pacientů na přípravku EVOTAZ se doporučuje pečlivé sledování a úprava dávkování metforminu.
Careful patient monitoring and dose adjustment of metformin is recommended in patients who are taking EVOTAZ.
U pacientů na tenofoviru
Patients receiving tenofovir should
U pacientů s akutním koronárním syndromem:
Patients suffering from acute coronary syndrome:
U pacientů s clearance kreatininu nižší než 70 ml/min nemá být léčba přípravkem EVOTAZ zahájena, pokud jeden nebo více souběžně podávaných léků vyžaduje úpravu dávkování na základě clearance kreatininu (např. emtricitabin, lamivudin, tenofovir-disoproxyl-fumarát nebo adefovir; viz body 4.2, 4.8 a 5.2).
EVOTAZ should not be initiated in patients with creatinine clearance less than 70 ml/min if one or more co-administered agent requires dose adjustment based on creatinine clearance (e.g. emtricitabine, lamivudine, tenofovir disoproxil fumarate or adefovir; see sections 4.2, 4.8 and 5.2).
U pacientů s hemofilií typu A a B léčenými inhibitory proteáz byly zaznamenány případy zvýšeného krvácení včetně spontánních kožních hematomů a hemartróz.
There have been reports of increased bleeding, including spontaneous skin haematomas and haemarthroses, in type A and B haemophiliac patients treated with protease inhibitors.
U pacientů s poruchou funkce ledvin jsou terapeutické zkušenosti omezené (viz bod 4.4).
Therapeutic experience is limited in patients with renal impairment (see section 4.4).
U pacientů s preexistujícími převodními poruchami (atrioventrikulární blok II. a vyššího stupně nebo blok ramének) se má přípravek EVOTAZ užívat s opatrností a pouze tehdy, když prospěch převáží možná rizika (viz bod 5.1).
In patients with pre-existing conduction problems (second degree or higher atrioventricular or complex bundle-branch block), EVOTAZ should be used with caution and only if the benefits exceed the risk (see section 5.1).
U pacientů s různými stupni poruchy funkce jater může být nutné snížení dávky.
Dose reduction may be required in patients with different degrees of hepatic impairment.
U pacientů s těžkou poruchou funkce jater kobicistat nebyl studován a jeho použití se u těchto pacientů nedoporučuje.
Cobicistat has not been studied in patients with severe hepatic impairment and is not recommended in these patients.
U pacientů se středně těžkou až těžkouporuchou funkce jater je užívání přípravku EVOTAZ kontraindikováno.
The use of EVOTAZ is contraindicated in patients with moderate to severe hepatic impairment.
U pacientů se středně těžkou nebo těžkou poruchou funkce jater se předpokládá zvýšení plazmatických koncentrací atazanaviru s kobicistatem (viz body 4.2 a 4.4).
Concentrations of atazanavir given with cobicistat are expected to be increased in patients with impaired hepatic function (see sections 4.2 and 4.4).
U pacientů se středně těžkým onemocněním jater, kteří mohou mít sklon ke krvácení, jsou terapeutické zkušenosti omezené (viz bod 4.4).
Therapeutic experience is limited in patients with moderate hepatic disease who may have bleeding diatheses (see section 4.4).
U pacientů se závažnou poruchou funkce ledvin (GFR 29-15 ml/min) a konečným stadiem renálního onemocnění (GFR<15 ml/min nebo vyžadující dialýzu) může být nutné snížení dávky.
Dose reduction may be required in patients with severe renal impairment (GFR 29-15 ml/min) and an end stage renal disease (GFR<15 ml/min) or requiring dialysis.
U pacientů užívajících atazanavir byly hlášeny Stevensův-Johnsonův syndrom (SJS), erythema multiforme, toxické kožní exantémy a léková vyrážka s eosinofilií a systémovými projevy (DRESS).
Stevens-Johnson syndrome (SJS), erythema multiforme, toxic skin eruptions and drug rash with eosinophilia and systemic symptoms (DRESS) syndrome have been reported in patients receiving atazanavir.
U pacientů užívajících léky obsahující atazanavir byly také zaznamenány případy neobvyklého bušení srdce.
There have been reports of unusual heart beat in patients taking atazanavir-containing regimen.
U pacientů, kteří neužívají
For patients not taking tenofovir,
U pacientů, kteří užívají
For patients who are taking
U pacientů, kteří užívají přípravek EVOTAZ, se může rozvinout závažná forma kožní vyrážky, včetně Stevens-Johnsonova syndromu.
Serious skin rash, including Stevens-Johnson syndrome, may develop in patients taking EVOTAZ.
U pacientů, kteří užívali atazanavir, složku přípravku EVOTAZ, byly hlášeny ledvinové kameny.
Kidney stones have been reported in patients taking atazanavir, a component of EVOTAZ.
U pacientů, kteří užívali EVOTAZ, se objevila hyperbilirubinemie (zvýšená hladina bilirubinu v krvi).
Hyperbilirubinaemia (an increase in the level of bilirubin in the blood) has occurred in patients receiving EVOTAZ.
U potkanů a králíků při dávkách pro matku již toxických nebyly pozorovány žádné teratogenní vlivy.
No teratogenic effects were observed in rats or rabbits at maternally toxic doses.
U potkanů se vyskytly změny osifikace páteře a sternebra u plodů v dávce, která vedla k významné mateřské toxicitě.
In rats, ossification changes in the spinal column and sternebra of foetuses occurred at a dose that produced significant maternal toxicity.
U starší populace (65 let věku a více) nebyla farmakokinetika atazanaviru a kobicistatu, samostatně ani v kombinaci, hodnocena.
The pharmacokinetics of atazanavir and cobicistat, alone or in combination, have not been evaluated in an elderly population (65 years of age and older).
U tejto populácie pacientov sa nesledovali žiadne relevantné rozdiely v bezpečnostnom profile.
No relevant differences in the safety profile were seen in this patient population.
U těchto antiepileptik se předpokládá snížení plazmatických koncentrací atazanaviru a/nebo kobicistatu.
These antiepileptics are expected to decrease atazanavir and/or cobicistat plasma concentrations.
U těchto sedativ/hypnotik může být
reduction may be necessary and concentration monitoring is recommended.
U väčšiny pacientov bolo hlásené reverzibilné akútne zvýšenie aspartatívnej aminotransferázy (AST) a alanínovej aminotransferázy (ALT).
Reversible acute increases in aspartate aminotransferase (AST) and alanine aminotransferase (ALT) have been reported in most patients.
U zdravých jedinců bylo ledvinami vyloučeno přibližně 7 % atazanaviru z podané dávky v nezměněné podobě.
In healthy subjects, the renal elimination of unchanged atazanavir was approximately 7% of the administered dose.
U štyridsiatich pacientov sa odozva dala v plnej miere vyhodnotiť.
Forty patients were fully evaluable for response.
U žádného pacienta se nevyvinula substituce K65R ani jakákoli jiná primární substituce spojená s rezistencí na inhibitory proteázy.
No subject developed the tenofovir-associated resistance substitution K65R or any primary resistance substitution associated with protease inhibitors.
u,HHKOB xJlOpH)],, rJlHu,epOJl, MeTaKpe3OJl, )],HHaTpHeB cpOCcpaT )],HxH)],paT, HaTpHeB xH)],pOKCH)],, xJlOpOBO)],OpO)],Ha KHCeJlHHa H BO)],a 3a HH)KeKu,HH.
zinc chloride, glycerol, metacresol, disodium phosphate dihydrate, sodium hydroxide, hydrochloric acid and water for injections.
U/l)
2,051.0
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