natgillin/translations-raw huggingface dataset:
<80 mL/min/1.73 m2), moderate (eGFR ≥30 and <50 mL/min/1.73 m2), severe renal impairment (eGFR <30 mL/min/1.73 m2) and subjects with ESRD requiring haemodialysis following a single 400 mg dose of sofosbuvir.
< 80 ml/min/1,73 m2), zmerno (eGFR ≥ 30 in < 50 ml/min/1,73m2) in hudo ledvično okvaro (eGFR < 30 ml/min/1,73 m2) ter pri osebah z ESRD, zaradi katere bolnik potrebuje hemodializo, po enkratnem 400-miligramskem odmerku sofosbuvirja.
<80-65 g/L (grade 3)
< 80-65 g/l (3. stopnja)
<=800,000 IU/mL
< = 800.000 i.e./ml
<=800,000 IU/mL‡
< = 800.000 i.e./ml
<[For HDPE bottle only:]>
[Samo za HDPE steklenice:]
<[For HDPE bottle only:]>
[Samo za HDPE steklenice]
<Batch> <Lot> <BN> number
<Serija> številka
<Batch> <Lot> <BN> {number}
<Serija> {številka}
<Batch> <Lot> <BN>{number}
<Serija> <Lot> <BN> {številka}
<Batch> <Lot> {number}
<serija> <Lot> {številka}
<DD month YYYY>
<{DD. mesec LLLL}>
<DD/MM/YY>
<DD/MM/LL>
<EXP {MM/YYYY}>
Uporabno do: (MM/LLLL)
<EXP {month/year}>
<EXP> {mesec/leto}
<EXP {month/year}>
EXP {mesec/leto}
<Justification for not including Braille accepted> 56 x 1 tablet
<Sprejeta razlaga, da Braillova pisava ni potrebna> 56 x 1 tableta
<Lot> {number}
<Lot> {številka}
<MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND> MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE
IZDELOVALEC(IZDELOVALCI) BIOLOŠKE ZDRAVILNE UČINKOVINE (ZDRAVILNIH UČINKOVIN) IN IMETNIK(I) DOVOLJENJ(A) ZA IZDELAVO ZDRAVILA, ODGOVOREN(ODGOVORNI) ZA SPROŠČANJE SERIJE
<MON, TUE, WED, THU, FRI, SAT, SUN>
<PON, TOR, SRE, ČET, PET, SOB, NED>
<month YYYY>
<mesec LLLL>
<Not applicable.>
< Navedba smiselno ni potrebna.>
<Not applicable.>]
<Navedba smiselno ni potrebna.>]
<Obligation to conduct post-authorisation measures>
Obveznost izvedbe ukrepov po pridobitvi dovoljenja za promet
<Open here>
<Odprite tu>
<Placeholder QR code>
<prostor za kodo QR>
<see side 1
< glejte 1. stran
<{MM/YYYY}>
{DD/MM/LLLL}
= 308) in the ultra-short zidovudine group (p = 0.00063)).
308) v skupini z ultrakratkim režimom zidovudina (p = 0,00063)).
= 359) with that of placebo plus BSC (n = 180) in patients with locally advanced (Stage IIIB) or metastatic (Stage IV) NSCLC other than predominantly squamous cell histology who did not progress after 4 cycles of first line doublet therapy of pemetrexed in combination with cisplatin.
=180) pri bolnikih z lokalno napredovanim (faza IIIB) ali metastatskim (faza IV) nedrobnoceličnim karcinomom pljuč, ki nima prevladujoče ploščatocelične histologije ter pri katerih ni bilo napredka po 4 ciklih zdravljenja prve izbire z dubletami pemetrekseda v kombinaciji s cisplatinom.
= 99, placebo: n = 44) in a randomised, double-blind, placebo controlled, 8 week study using a fixed dose weight-based treatment group design over the dose range of 5 mg/day to 20 mg/day and a starting dose of 2 mg.
n = 99, placebo: n = 44) v 8-tedenski randomizirani, dvojno slepi, s placebom nadzorovani študiji, zasnovani z zdravljenimi skupinami, ki so prejemale nespremenjen odmerek glede na telesno maso posameznika v razponu od 5 mg/dan do 20 mg/dan, z začetnim odmerkom 2 mg.
= Amount to inject in ml
= količina za injiciranje v ml
= body weight (kg) times 50 (U/kg)
= telesna masa (kg) krat 50 (e./kg)
= body weight (kg) times 50 (U/kg)
telesna masa (kg) krat 50 (e./kg)
= complete haematologic response (CHR) + no evidence of leukaemia (NEL).
+ brez znakov levkemije.
= every 6 hours, Gy= Gray
< 0,1 μM, Gy= Gray
= G3/4; grade 4 = G4), the COSTART and the MedDRA terms.
= S3/4, 4. stopnja = S4) in z izrazi COSTART in MedDRA.
= Serum calcium (mg/dl) + 0.8 x [4 - albumin (g/dl)]
= koncentracija kalcija v serumu (mg/dl) + 0,8 x [4 – albumin (g/dl)]
= Serum calcium (mmol/l) - [0.02 x albumin (g/l)] + 0.8
= koncentracija kalcija v serumu (mmol/l) – [0,02 x albumin (g/l)] + 0,8
> 1 to 3 x Upper Limit of Normal (ULN)
> 1- do 3-kratna
> 1,000 copies/ml.
> 1.000 kopij/ml.
> 1,000/microlitre).
> 1.000/mikroliter).
> 1,500 cells/mm3 and platelets recover to a level > 100,000 cells/mm3.
> 1.500 celic/mm3 in število trombocitov na > 100.000 celic/mm3.
> 1.0 x 1.5 x ULN
> 1,0 x1,5 x ULN
> 1.0 x – 1.5 x ULN
> 1,0–1,5x ULN
> 1.5 to ≤ 2.0 x ULN
> 1,5 do ≤ 2,0 x ZMN
> 1.5 to ≤ 3.0 x ULN
> 1,5 to ≤ 3,0 x ZMN
> 1.5 x 3 x ULN
> 1,5 x3 x ULN
> 1.5 x ULN) in the tenofovir disoproxil fumarate treatment group and 0% (0/32) of patients in the placebo group had HBV DNA < 400 copies/ml.
≥ 105 kopij/ml, ALT v serumu > 1,5 x ZMN) v skupini, zdravljeni z dizoproksiltenofovirijevim fumaratom in 0% (0/32) bolnikov v skupini s placebom, imelo HBV DNA < 400 kopij/ml.
> 1.5 x – 3 x ULN
> 1,5–3x ULN
> 10 kg: Continue with dose of
> 10 kg: Nadaljujte z odmerkom
> 10 x ULN*
10 x ZMN
> 10 x ULN*
> 10 x ZMN
> 100,000 copies/mL
> 100.000 kopij/ml
> 100,000 copies/mL (n = 44)
> 100.000 kopij/ml (n = 44)
> 100,000 copies/mL) and the class of the second agent (NRTI or other classes).
(≤ 100.000 kopij/ml ali > 100.000 kopij/ml) in razred drugega zdravila (NRTI ali drugi razredi).
> 100,000 copies/mL.
> 100.000 kopij/ml.
> 100,000/µl to ≤ 150,000/µl
> 100.000/µl do  150.000/µl
> 12 months (n=282)
> 12 mesecev (n = 282)
> 12 years to < 18 years and bodyweight < 33 kg
> 12 let do < 18 let in s telesno maso < 33 kg
> 15 kg to 23 kg
> 15 do 23 kg
> 150,000/µl
> 150.000/µl
> 150,000/µl to  250,000/µl
> 150.000/µl do  250.000/µl
> 1500 µmol/L.min following 1 mg/kg.
1500 µmol/l·min po odmerku 1 mg/kg.
> 18 weeks.
18 tednov.
> 1st-line therapy
več kot prva linija zdravljenja
> 2 million copies/mL
> 2 milijona kopij/ml
> 2 months, and reduced the skeletal morbidity rate.
> 2 meseca in zmanjšala stopnjo obolevnosti skeleta.
> 2-6 months
> 2–6 mesecev
> 2.0 to ≤ 5.0 x ULN
> 2,0 do ≤ 5,0 x ZMN
> 200 cells/mm3
> 200 celic/mm3
> 200 copies/ml.
> 200 kopij/ml.
> 23 kg to 40 kg
> 23 do 40 kg
> 25% of the bone marrow infiltrated by lymphoma cells
več kot 25 % kostnega mozga infiltriranega z limfomskimi celicami
> 25,000/mm3
> 25.000/mm3
> 250 mg/dL or > 13.9 mmol/L) or associated with ketoacidosis Hyperthyroidism Grade ≥ 3
ali > 13,9 mmol/l) ali s ketoacidozo hipertiroidizem 3. stopnje
> 250,000/µl
> 250.000/µl
> 265 µmol/l or > 3.0 mg/dl were excluded.
> 3,0 mg/dl so bili iz kliničnih preskušanj z zdravilom Zometa izključeni.
> 3 and  5  ULN The result should be confirmed by a second liver test; if confirmed, a decision should be made on an individual basis to continue STAYVEER, possibly at a reduced dose, or to stop STAYVEER administration (see section 4.2).
> 3 in  5  ZMN Rezultat je treba potrditi še z drugo preiskavo jetrnih encimov; če je potrjen, se za vsakega posameznega bolnika odločite, ali boste z zdravljenjem z zdravilom STAYVEER nadaljevali, morebiti znižali odmerek ali dajanje zdravila STAYVEER prekinili (glejte poglavje 4.2).
> 3 and  5  ULN The result should be confirmed by a second liver test; if confirmed, a decision should be made on an individual basis to continue Tracleer, possibly at a reduced dose, or to stop Tracleer administration (see section 4.2).
> 3 in  5  ZMN Rezultat je treba potrditi še z drugo preiskavo jetrnih encimov; če je potrjen, se za vsakega posameznega bolnika odločite, ali boste z zdravljenjem z zdravilom Tracleer nadaljevali, morebiti znižali odmerek ali dajanje zdravila Tracleer prekinili (glejte poglavje 4.2).
> 3 hours to
> 3 ure do
> 3 to 5 x ULN
> 3- do 5-kratna
> 3 to 5 x ULN
> 3- do 5-kratna ZMN
> 3 x ULN
> 3-kratna ULN
> 3 × ULN*
> 3 x ULN
> 3.0 to ≤ 5.0 x ULN
> 3,0 to ≤ 5,0 x ZMN
> 3.5 excess 13C = Positive
 3,5 presežek 13C = pozitivno
> 300 mg/dl)
> 3.000 mg/l)
> 4 mg/dL (for > 4 weeks) (children and adolescents treated with peginterferon alfa-2b)
> 4 mg/dl (> 4 tedne) (otroci in mladostniki, zdravljeni s peginterferonom alfa-2b)
> 4 mg/dL (for > 4 weeks) (children and adolescents treated with peginterferon alfa-2b)
≥ 4 mg/dl (> 4 tedne) (otroci in mladostniki, zdravljeni s peginterferonom alfa-2b)
> 4 seizures during 3 month baseline period
> 4 epileptični napadi med 3-mesečnim izhodiščnim obdobjem
> 400 copies/mL at virologic failure, at Week 48, at Week 96, at Week 144 or at the time of early study drug discontinuation.
96. tednu, v 144. tednu ali ob zgodnji prekinitvi jemanja študijskega zdravila.
> 5 and ≤ 8 x ULN: Confirm by another liver test; if confirmed, stop treatment and monitor aminotransferase levels at least every 2 weeks until levels have normalised.
Če je stanje potrjeno, prekinite zdravljenje in spremljajte vrednosti aminotransferaz najmanj vsaka 2 tedna, dokler se ne normalizirajo.
> 5 and  8  ULN The result should be confirmed by a second liver test; if confirmed, treatment should be stopped and aminotransferase levels monitored at least every 2 weeks.
> 5 in  8  ZMN Rezultat je treba potrditi še z drugo preiskavo jetrnih encimov; če je potrjen, je treba zdravljenje prekiniti in spremljati ravni aminotransferaz vsaj na vsaka 2 tedna.
> 5 mg/dL
> 5 mg/dl
> 5 mg/dl
Kreatinin v serumu
> 5 mg/dL (for > 4 weeks) (children and adolescents treated with interferon alfa-2b) or
≥ 5 mg/dl (> 4 tedne) (otroci in mladostniki, zdravljeni s peginterferonom alfa-2b) ali
> 5 x IULN occur, Glivec should be withheld until bilirubin levels have returned to < 1.5 x IULN and transaminase levels to < 2.5 x IULN.
> 5-kratno IULN, je treba zdravljenje z zdravilom Glivec prekiniti, dokler se koncentracija bilirubina ne vrne na < 1,5-kratno IULN oziroma koncentracija aminotransferaz na < 2,5-kratno IULN.
> 5 x ULN
> 5-kratna ULN
> 5 x ULN
> 5-kratna ZMN
> 5% blasts in bone marrow, ECOG performance status ≤ 2, life expectancy of ≥ 12 weeks, who did not have autologous haematopoietic stem cell transplantation (HSCT) within 6 weeks prior to start of BLINCYTO treatment, allogeneic HSCT within 3 months prior to start of BLINCYTO treatment, or previous treatment with BLINCYTO), the safety and efficacy of BLINCYTO were evaluated.
≥ 12 tednov ter niso imeli avtologne presaditve krvotvornih matičnih celic v 6 tednih pred začetkom zdravljenja z zdravilom BLINCYTO, alogenske presaditve krvotvornih matičnih celic v 3 mesecih pred začetkom zdravljenja z zdravilom BLINCYTO ali predhodnega zdravljenja z zdravilom BLINCYTO).
> 50 and
> 50 in ≤ 200 celic/mm3
> 50 and ≤ 200 cells/mm3
> 50 in ≤ 200 celic/mm3
> 50 kg Body Weight
telesna masa > 50 kg
> 500 IU/l
> 500 i.e./l
> 500 ng/ml at baseline
> 500 ng/ml ob izhodišču
> 500 ng/ml at Week 12
> 500 ng/ml v 12. tednu
> 500 ng/ml at Week 52
> 500 ng/ml v 52. tednu
> 54 weeks (< 0.001)
> 54 tednov (< 0,001)
> 5x ULN
> 5-kratna ZMN
> 6 months
> 6 mesecev
> 60 4.0 mg zoledronic acid
> 60 4,0 mg zoledronske kisline
> 60 years of age or
tarost nad 60 let ali
> 600,000 IU/ml
> 600.000 i.e./ml
> 7 days, repeat step 1 and resume treatment at a reduced dose of 80 mg once daily for second episode.
0,5 x 109/l za > 7 dni, ponovite postopek, opisan pod zaporedno številko 1, in nato ponovno uvedite zdravljenje, in sicer z zmanjšanim odmerkom 80 mg enkrat na dan (druga ponovitev).
> 70 kg (4.6 µg/ml, 17.8 µg/ml, 545 µg*d/ml).
17,8 µg/ml, 545 µg*d/ml).
> 75 years of age if co-administered with ASA alone or with ASA plus clopidogrel or ticlopidine with low body weight (< 60 kg) if co-administered with ASA alone or with ASA plus clopidogrel or ticlopidine
o stari > 75 let in sočasno prejemajo samo acetilsalicilno kislino ali acetilsalicilno kislino in klopidogrel ali tiklopidin imajo nizko telesno maso (< 60 kg), če sočasno prejemajo samo acetilsalicilno kislino ali acetilsalicilno kislino in klopidogrel ali tiklopidin
> 75,000/l, only 14% of 309 patients had a count ≤ 25,000/l during the study.
Izmed 309 bolnikov, ki so imeli začetno število trombocitov > 75.000/l, jih je le 14% imelo med preskušanjem število trombocitov  25.000/l.
> 8 x ULN or any of the above with associated clinical symptoms of liver injury: Treatment must be stopped and re-introduction of Tracleer is not to be considered.
>8 x ZMN ali vsaka od zgoraj navedenih, pri čemer se pojavijo klinični simptomi okvarjenega delovanja jeter: Zdravljenje morate prekiniti in ponovna uvedba zdravljenja z zdravilom Tracleer ni dovoljena. da je zdravljenje z zdravilom Tracleer povezano z znižanjem hemoglobina
> 8  ULN Treatment must be stopped and re-introduction of STAYVEER is not to be considered.
> 8  ZMN Zdravljenje moramo prekiniti in ponovna uvedba zdravljenja z zdravilom STAYVEER ni dovoljena.
> 8  ULN Treatment must be stopped and re-introduction of Tracleer is not to be considered.
> 8  ZMN Zdravljenje moramo prekiniti in ponovna uvedba zdravljenja z zdravilom Tracleer ni dovoljena.
> 80 ml/min) undergoing orthopaedic surgery and receiving fondaparinux 2.5 mg once daily, plasma clearance is 1.2 to 1.4 times lower in patients with mild renal impairment (creatinine clearance 50 to 80 ml/min) and on average 2 times lower in patients with moderate renal impairment (creatinine clearance 30 to 50 ml/min).
očistek > 80 ml/min), ki so imeli ortopedsko operacijo in so dobivali fondaparinuks v odmerku 2,5 mg enkrat na dan, je pri bolnikih z blago okvaro delovanja ledvic (kreatininski očistek 50 do 80 ml/min) plazemski očistek 1,2 do 1,4- krat manjši in v povprečju 2-krat manjši pri bolnikih z zmerno okvaro delovanja ledvic (kreatininski očistek 30 do 50 ml/min).
> age appropriate ULN**
nad starostno ustrezno zgornjo mejo normale
>1 log reduction in HIV RNA or
Zmanjšanje HIV RNA za > 1 log ali < 50 kopij/ml
>1 mg/kg/day but no maternal reproductive toxicity was observed up to 3 mg/kg/day (estimate exposure >2.3 times the AUC in patients administered the RDD).
 1 mg/kg/dan, toda nobenega toksičnega vpliva na sposobnost razmnoževanja samic niso opazili pri odmerkih do 3 mg/kg/dan (ocena izpostavljenosti  2,3-kratnik vrednosti AUC pri bolnikih, ki prejemajo RDD).
>1 to ≤ 2 years
> 1 do ≤ 2 leti
>1 to ≤2 years
> 1 do ≤ 2 leti
>1,000 µg/l
>1.000 µg/l
>1,500cells/mm3 and platelets recover to a level >100,000 cells/mm3.
3 število trombocitov na > 100.000 celic/mm .
>1.0 x 109/l and/or platelets
ANC >1,0 x 109/l in/ali število trombocitov
>10 to ≤20 x ULN
> 10- do ≤ 20-kratna vrednost ULN
>10 ULN
> 10 ULN
>10 × ULN (grade 4)
> 10 × ZNM (4. stopnja)
>10% (N=72)
>10 % (N=72)
>10% to ≤15%
> 10 % do ≤ 15
>10,000 – 100,000 copies/ml
>10.000 – 100.000 kopij/ml
>10.0 × ULN (Grade 4)
> 10,0 × ZNM (4. stopnja)
>100,000 copies/ml
>100,000 kopij/ml
>100,000 copies/ml
>100.000 kopij/ml
>100,000 copies/ml, n (%)
> 100.000 kopij/ml, n (%)
>12 to ≤18 years
> 12 do ≤ 18 let
>14 ml/kg/month of PRBC (approx.
>14 ml/kg/mesec koncentriranih eritrocitov (približno
>15% to ≤20%
> 15 % do ≤ 20
>18 to ≤64 years
> 18 do ≤ 64 let
>1X – 3X upper normal limit
>1X – 3X nad zgornjo referenčno mejo
>2 months N=5 (%)
>2 meseca n = 5 (%)
>2 to ≤5 years
> 2 do ≤ 5 let
>2,000 µg/l
>2.000 µg/l
>2,000 µg/l
prilagajanje
>2,500 µg/l
pri >2.500 µg/l
>20 hours.
>20 ur.
>20 ULN
> 20 ULN
>20 x ULN
> 20-kratna vrednost ULN
>20 × ULN (Grade 4)
> 20 × ZMN (4. stopnja)
>20 × ULN (Grade 4)
> 20 × ZNM (4. stopnja)
>20% none
>20
>20% to ≤25%
> 20 % do ≤ 25
>2xULN (N=139)
>2xZMN (N=139)
>3 and ≤ 5 x ULN: Confirm levels and if confirmed, reduce the daily dose or stop treatment and monitor liver function at least every 2 weeks.
>3 in ≤5 x ZMN: potrdite vrednosti in če so potrjene, znižajte dnevni odmerek ali zdravljenje prekinite ter spremljajte delovanje jeter vsaj vsaka 2 tedna.
>3 and ≤ 5 x ULN: Confirm by another liver test; if confirmed, a decision should be made on an individual basis to continue or to stop Thelin administration.
> 3 in ≤ 5 × ZMN Potrdite z drugo preiskavo jeter; če je stanje potrjeno, se morate odločiti za nadaljevanje ali prekinitev zdravljenja z zdravilom Thelin za vsakega bolnika posebej.
>3 and  5 x ULN: Confirm levels and if confirmed, reduce the daily dose or stop treatment and monitor liver function at least every 2 weeks.
>3 in ≤5 x ZMN: potrdite vrednosti in če so potrjene, znižajte dnevni odmerek ali zdravljenje prekinite ter spremljajte delovanje jeter vsaj vsaka 2 tedna.
>3 times ULN (Grade 2 or higher) with concurrent bilirubin >2 times ULN
> 3-kratnik ULN (2. ali višje stopnje) s sočasnimi vrednostmi bilirubina > 2-kratnik ULN
>3 to ≤5 x ULN
> 3- do ≤ 5-kratna vrednost ULN
>3 ULN
> 3 ULN
>3-10 × ULN (grade 3)
> 3-10 × ZNM (3. stopnja)
>3.5 times the ULN associated with alkaline phosphatase >6 times the ULN, no dose-reduction can be recommended and docetaxel should not be used unless strictly indicated.
> 3,5-kratno ULN ter hkrati alkalno fosfatazo > 6-kratno ULN, ni mogoče priporočiti zmanjšanja odmerka; pri teh bolnikih se docetaksela ne sme uporabljati, če ni strogo indiciran.
>33% above pre- treatment average
>33 % nad povprečjem vrednosti pred zdravljenjem
>35 years
≥35 let
>4 units/month for an adult)
>4 enote/mesec pri odraslem)
>45 minutes increase in average nighttime sleep duration
>45-minutno skrajšanje povprečnega trajanja spanja podnevi
>5 and ≤ 8 x ULN: Confirm levels and if confirmed stop treatment and monitor liver function at least every 2 weeks.
>5 in ≤8 x ZMN: potrdite vrednosti in če so potrjene, zdravljenje prekinite ter spremljajte delovanje jeter vsaj vsaka 2 tedna.
>5 and  8 x ULN: Confirm levels and if confirmed stop treatment and monitor liver function at least every 2 weeks.
>5 in ≤8 x ZMN: potrdite vrednosti in če so potrjene, zdravljenje prekinite ter spremljajte delovanje jeter vsaj vsaka 2 tedna.
>5 times ULN
> 5-kratnik ULN do
>5 to ≤10 x ULN
> 5- do ≤ 10-kratna vrednost ULN
>5 to ≤12 years
> 5 do ≤ 12 let
>5 ULN
> 5 ULN
>5% to ≤10%
> 5 % do ≤ 10
>5-20 × ULN* (Grade 3)
> 5-20 × ZNM* (3. stopnja)
>5.0 × ULN (Grade 4)
> 5,0 × ZNM (4. stopnja)
>5.0x ULN
> 5,0 x ZNM
>5.5 and <6.7 mmol/l (>100 and <120 mg/dl)
> 5,5 in < 6,7 mmol/l (> 100 in < 120 mg/dl)
>50 years
≥50 let
>50,000 copies/mL
> 50.000 kopij/ml
>6 to 8 hours after first dose
V obdobju od 6 do 8 ur po prejemu prvega odmerka
>8 x ULN: treatment must be stopped and reintroduction of Thelin is not to be considered.
> 8 × ZMN: Zdravljenje je treba končati, ponovna uvedba zdravila Thelin pa ne pride v poštev.
>80 years
50,0
>80 years
71 do 80 let
>80 years
[22,9;
>800,000 IU/mL
> 800.000 i.e./ml
>800,000 IU/mL†
> 800.000 i.e./ml
>99% of Xiapex-treated patients developed high titers of antibodies to both AUX-I and AUX-II.
> 99 % bolnikov, zdravljenih z zdravilom Xiapex, razvilo visoke titre protiteles proti AUX-I in AUX-II.
>=100,000 copies/mL
>=100.000 kopij/ml
>R (Resistant)
> R (odporen)
>ULN (N=87)
>ZMN (N=87)
[% of original dose]
[ % originalnega odmerka]
[-1.36, -0.51], p<0.0001. There was also a statistically significant improvement over placebo with the rasagiline 0.5 mg group, yet the magnitude of improvement was lower.
Tudi v skupini z 0,5 mg razagilina je bilo v primerjavi s placebom statistično pomembno izboljšanje, vendar je bil obseg izboljšanja manjši.
[-10.5%, 4.4%]
mutacija
[-4.3%, 2.0%]
ROG 1,24
[-5.7, -2.7]; p<0.0001; for rasagiline 2 mg compared to placebo -3.6, 95% CI [-5.0, -2.1]; p<0.0001, UPDRS Motor, part II: for rasagiline 1 mg compared to placebo -2.7, 95% CI [-3.87, -1.55], p<0.0001; for rasagiline 2 mg compared to placebo -1.68, 95% CI [-2.85, -0.51], p=0.0050).
< 0.0001; za razagilin 2 mg v primerjavi s placebom -3,6, 95 % CI [-5,0, -2,1]; p < 0.0001; UPDRS motorični, del II: za razagilin 1 mg v primerjavi s placebom -2,7, 95 % CI [-3,87, -1,55]; p < 0.0001; za razagilin 2 mg v primerjavi s placebom -1,68, 95 % CI [-2,85, -0,51]; p = 0.0050).
[-5.7, -2.7]; p<0.0001; for rasagiline 2 mg compared to placebo -3.6, 95% CI [-5.0, -2.1]; p<0.0001, UPDRS Motor, part II: for rasagiline 1 mg compared to placebo -2.7, 95% CI [-3.87, -1.55], p<0.0001; for rasagiline 2 mg compared to placebo -1.68, 95% CI [-2.85, -0.51], p=0.0050).
motorični, del II: za razagilin 1 mg v primerjavi s placebom -2,7, 95% CI [-3,87, -1,55]; p < 0,0001; za razagilin 2 mg v primerjavi s placebom -1,68, 95% CI [-2,85, -0,51]; p = 0,0050).
[-8.2%, 46.0%]
ROG 0,16
[0.58 to 0.81]
[0,70-0,96]
[0.64, 1.08]
mutacija
[0.70 to 0.96]
[7,3 %, 20,6 %]
[100 and 250 ml vials]
[Viale po 100 ml in 250 ml]
[140-age (years)] x weight (kg)
[140 – starost (leta)] x masa (kg)
[140-age( years)] x weight (kg)
[140 – starost (leta)] x masa (kg)
[14C]-dapagliflozin dose, 96% was recovered, 75% in urine and 21% in feces.
[14C]-dapagliflozina se je izločenega pojavilo 96 %, in sicer 75 % v urinu in 21 % v blatu.
[150 mg single dose (sustained
[150 mg enkratni odmerek (podaljšano
[150 mg single dose (sustained release)/600 mg once daily]
[150 mg enkratni odmerek (podaljšano sproščanje)/600 mg enkrat na dan]
[150 mg single dose (sustained release)/600 mg q.d.]
[150 mg posamezen odmerek (podaljšano
[19.9%, 27.1%]
bolniki z delnim
[1] P-values for comparison versus pre-Tx values were computed using paired t-tests.
P-vrednosti za primerjanje z vrednostmi pre-Tx so bile izračunane s pomočjo parnega t-testa.
[2 spray bottle:]
[Steklenica z 2 vpihoma:]
[20 and 50 ml vials]
[Viale po 20 ml in 50 ml]
[296.2;557.4]
Polovični odmerek za odrasle4
[90Y]-radiolabelled ibritumomab tiuxetan binds specifically to CD20-expressing B-cells, including malignant cells.
Z [90Y] označeni ibritumomab tiuksetan se veže specifično na celice B, ki imajo izražen CD20, vključno z malignimi celicami.
[90Y]-radiolabelled Zevalin is indicated as consolidation therapy after remission induction in previously untreated patients with follicular lymphoma.
Z [90Y] označeno zdravilo Zevalin je indicirano kot konsolidacijsko zdravljenje t.j. za utrjevanje odgovora, ki je bil dosežen z indukcijskim zdravljenjem pri predhodno nezdravljenih bolnikih s folikularnim limfomom.
[90Y]-radiolabelled Zevalin is indicated for the treatment of adult patients with rituximab relapsed or refractory CD20+ follicular B-cell non-Hodgkin's lymphoma (NHL).
Z [90Y] označeno zdravilo Zevalin je indicirano za zdravljenje odraslih bolnikov z ne-Hodgkinovim limfomom (NHL) folikularnih celic B CD20+, ki je po rituksimabu recidiviral ali je zanj neodziven.
[90Y]-radiolabelled Zevalin must only be received, handled and administered by qualified personnel and must be prepared in accordance with both radiation safety and pharmaceutical quality requirements (for more details see also sections 4.4, 6.6 and 12).
Z [90Y] označeno zdravilo Zevalin sme sprejeti, uporabljati in aplicirati le strokovno usposobljeno osebje, ki ga mora pripraviti v skladu z zahtevami za varstvo pred sevanjem in farmacevtsko kakovost (za več podrobnosti glejte tudi poglavja 4.4, 6.6 in 12).
[90Y]-radiolabelled Zevalin solution must not be administered to patients who are likely to develop life-threatening haematological toxicity signs.
Z [90Y] označeno zdravilo Zevalin se ne sme dajati bolnikom, pri katerih obstaja nevarnost za življenje ogrožajoče hematološke toksičnosti.
[90Y]-radiolabelled Zevalin solution must only be received, handled and administered by qualified personnel with the appropriate government authorization for the use and manipulation of radionuclides within a designated clinical setting.
Z [90Y] označeno zdravilo Zevalin sme uporabljati le strokovno usposobljeno osebje z ustreznim pooblastilom pristojnega organa za uporabo in rokovanje z radioizotopi v določenem kliničnem okolju.
[93.9;100]
serološke zaščite1
[95% CI: -1.1; 12.0]
5,4 % [95 % IZ: -1,1, 12,0]
[95% CI: -1.1; 12.0]
[95 % IZ: -1,1, 12,0]
[95% CI: -1.1; 12.0]
[95-% IZ: -1,1; 12,0]
[95% CI: -1.1; 12.0]
VCis n = 404
[95% CI: 0.2; 12.3]
[95 % IZ: 0,2, 12,3]
[95% CI: 0.2; 12.3]
[95-% IZ: 0,2; 12,3]
[95% CI: 0.876; 1.216]
0,876, 1,216]
[95% CI: 0.876; 1.216]
[95 % IZ: 0,876, 1,216]
[95% CI: 0.876; 1.216]
[95-% IZ: 0,876; 1,216]
[95% CI]
25,0
[95% CI]
[95-odstotni IZ]
[95% CI]
CR+PR(dnevi)
[95% CI]
Najboljši odziv (%)
[97.2% CI: 0.937; 1.342]*
[95 % IZ: 0,876, 1,216]
[97.2% CI: 0.937; 1.342]*
[97,2 % IZ: 0,937, 1,342]
[97.2% CI: 0.937; 1.342]*
[97,2-% IZ: 0,937; 1,342]
[98.4; 99.9]
Časovna točka
[Actavis logo]
Actavis logotip
[arrow] Tear here
[puščica] Odprite tukaj
[Bayer logo]
[Bayer logotip]
[Box for the prescription dose]
Uporabljajte v skladu s spodnjimi navodili: [Polje za predpisovanje odmerkov]
[CK elevation >ULN - 2.5 x ULN]
[zvišanje vrednosti kreatin-kinaze od >ZMN do 2,5-kratnika ZMN]
[CYP2C9 and CYP3A4
[substrati CYP2C9 in
[CYP2C9 substrate and potent
[substrat CYP2C9 in močan
[CYP2C9 substrate]
[substrat CYP2C9]
[CYP2C9 substrates]
[substrati CYP2C9 ]
[CYP3A4 substrate, P-gp
[substrat CYP3A4, substrat