natgillin/translations-raw huggingface dataset:
The proportion of responders (HIV-1 RNA <50 c/mL) at week 24 was predicted to increase around 4-18% in the subjects with Q148 + ≥2 secondary mutations from G140A/C/S, E138A/K/T, L74I. 
Napovedano povečanje deleža odzivnih (HIV-1 RNA < 50 kopij/ml) v 24. tednu je bilo približno 4-18 % pri preiskovancih s Q148 +
Nelfinavir 
Odmerek
Rare side effects These may affect up to 1 in 1000 people: 
Ti se lahko pojavijo pri največ 1 od 1000 bolnikov:
Dolutegravir did not affect male or female fertility in rats at doses up to 1000 mg/kg/day, the highest dose tested (24 times the 50 mg twice daily human clinical exposure based on AUC). 
1000 mg/kg/dan je bil največji testirani odmerek (24-kratnik klinične izpostavljenosti pri človeku med uporabo 50 mg dvakrat na dan, na podlagi AUC).
Package leaflet: Information for the patient 
Preglednica 1: Priporočila za odmerjanje pri pediatričnih bolnikih
No data are available in patients with severe hepatic impairment (Child-Pugh grade C); therefore dolutegravir should be used with caution in these patients (see section 5.2). 
Pri teh bolnikih je zato priporočljiva previdna uporaba dolutegravirja (glejte poglavje 5.2).
Tivicay 10 mg film-coated tablets are white, round, biconvex tablets marked with the code ‘SV 572' on one side and ‘10' on the other side. 
Tivicay 10 mg filmsko obložene tablete so bele, okrogle, bikonveksne tablete z oznako ‘SV 572' na eni in ‘10' na drugi strani.
Subjects were enrolled with a screening plasma HIV-1 RNA of 1000 
V raziskavo so bili vključeni preiskovanci s HIV-1 RNA v plazmi med 1000 kopij/mL in ≤500,000 kopij/mL.
Yellow, round, biconvex tablets approximately 9 mm in diameter debossed with ‘SV 572' on one side and ‘50' on the other side. 
Rumene, okrogle, bikonveksne tablete premera približno 9 mm, z vtisnjeno oznako ‘SV 572' na eni in ‘50' na drugi strani.
Tivicay 10 mg film-coated tablets 
Tivicay 10 mg filmsko obložene tablete
EU/1/13/892/004 EU/1/13/892/005 EU/1/13/892/006 
EU/1/13/892/003 EU/1/13/892/004
White, round, biconvex tablets approximately 6 mm in diameter debossed with ‘SV 572' on one side and ‘10' on the other side. 
Bele, okrogle, bikonveksne tablete premera približno 6 mm, z vtisnjeno oznako ‘SV 572' na eni in ‘10' na drugi strani.
Median baseline CD4+ was 160 cells/mm3, median duration of prior ART was 13 years, and 63% were CDC Class C. Subjects showed multiple class ART resistance at baseline: 80% had ≥2 NRTI, 73% ≥1 NNRTI, and 67% ≥2 PI major mutations; 83% had non-R5 virus. 
Preiskovanci so imeli izhodiščno odpornost proti več skupinam antiretrovirusnih zdravil: 80 % je imelo ≥ 2 NRTI, 73 % ≥ 1 NNRTI in 67 % ≥ 2 PI večji mutaciji; 83 % jih je imelo virus ne-R5.
Cmax ↓ 72% (Complex binding to polyvalent ions) 
(Tvori kompleks s polivalentnimi ioni)
Tivicay 25 mg film-coated tablets are pale yellow, round, biconvex tablets marked with the code ‘SV 572' on one side and ‘25' on the other side. 
Tivicay 25 mg filmsko obložene tablete so bledo rumene, okrogle, bikonveksne tablete z oznako ‘SV 572' na eni in ‘25' na drugi strani.
At baseline, median patient age was 49 years, 20% were female, 58% non-white, and 23% had hepatitis B and/or C co-infection. 
Izhodiščno je bila mediana starost bolnikov 49 let, 20 % je bilo žensk, 58 % nebelcev in 23 %
Netherlands. 
Nizozemska
At baseline, median patient age was 35 years, 16% were female, 32% nonwhite, 7% had hepatitis C co-infection and 4% were CDC Class C, these characteristics were similar between treatment groups. 
16% je bilo žensk, 32% nebelcev, 7% jih je imelo sočasno okužbo z virusom hepatitisa C, 4% pa jih je bilo razvrščenih v CDC razred C; te lastnosti so bile pri obeh terapevtskih skupinah podobne.
Do not take a calcium supplement, iron supplement or multivitamin during the 6 hours before you take Tivicay, or for at least 2 hours after you take it (see also Section 3). 
Tivicay ali vsaj 2 uri po tem, ko ste ga vzeli, ne jemljite kalcijevega dodatka, železovega dodatka ali multivitaminskega pripravka (glejte tudi poglavje 3).
Pale yellow, round, biconvex tablets approximately 7 mm in diameter debossed with ‘SV 572' on one side and ‘25' on the other side. 
Bledo rumene, okrogle, bikonveksne tablete premera približno 7 mm, z vtisnjeno oznako ‘SV 572' na eni in ‘25' na drugi strani.
Tivicay 25 mg film-coated tablets 
Tivicay 25 mg filmsko obložene tablete
Rebound up to week 48 b 
Virološki odboj po predhodno potrjeni supresiji do 48. tednab
When co-administered with dolutegravir 50mg once daily: 
Med sočasno uporabo z dolutegravirjem 50 mg enkrat na dan: metformin
• stiffness in the joints 
• nelagodje v želodcu
In vivo, a 10-14% decrease of creatinine clearance (secretory fraction is dependent on OCT2 and MATE-1 transport) was observed in patients. 
In vivo so pri bolnikih opazili 10-14% zmanjšanje očistka kreatinina
Antiviral activity in combination with other antiviral agents No antagonistic effects in vitro were seen with dolutegravir and other antiretrovirals tested: stavudine, abacavir, efavirenz, nevirapine, lopinavir, amprenavir, enfuvirtide, maraviroc and raltegravir. 
Pri testiranju dolutegravirja in drugih protivirusnih zdravil, kot so stavudin, abakavir, efavirenz, nevirapin,
MARKETING AUTHORISATION NUMBER(S) EU/1/13/892/001 
ŠTEVILKA (E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/13/892/001
Tivicay 50 mg film-coated tablets 
Tivicay 50 mg filmsko obložene tablete
Tivicay 50 mg film-coated tablets are yellow, round, biconvex tablets marked with the code ‘SV 572' on one side and ‘50' on the other side. 
Tivicay 50 mg filmsko obložene tablete so rumene, okrogle, bikonveksne tablete, z vtisnjeno oznako ‘SV 572' na eni in ‘50' na drugi strani.
Each film-coated tablet contains dolutegravir sodium equivalent to 10 mg dolutegravir. 
Ena filmsko obložena tableta vsebuje 10 mg dolutegravirja (v obliki natrijeve soli).
Dolutegravir ↓ AUC ↓ 22% Cmax ↓ 11% C24 ↓ 38% (induction of UGT1A1 and CYP3A enzymes) 
darunavir/ritonavir dolutegravir ↓ AUC ↓ 22% Cmax ↓ 11% C24 ↓ 38% (indukcija encimov UGT1A1 in CYP3A)
Each film-coated tablet contains dolutegravir sodium equivalent to 25 mg dolutegravir. 
Ena filmsko obložena tableta vsebuje 25 mg dolutegravirja (v obliki natrijeve soli).
Clade C 
CDC.
• a high temperature (fever) 
• povišano telesno temperaturo (vročina) • pomanjkanje energije (utrujenost)
MARKETING AUTHORISATION NUMBER(S) EU/1/13/892/005 
ŠTEVILKA (ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET Z ZDRAVILOM EU/1/13/892/005
In rabbits, maternal toxicity (decreased food consumption, scant/no faeces/urine, suppressed body weight gain) was observed at 1000 mg/kg (0.40 times the 50 mg twice daily human clinical exposure based on AUC). 
zavrto pridobivanje telesne mase) opažali pri 1000 mg/kg (0,40-kratnik klinične izpostavljenosti pri človeku med uporabo 50 mg dvakrat na dan na podlagi AUC).
When co-administered with dolutegravir 50mg twice daily: 
Med sočasno uporabo z dolutegravirjem 50 mg dvakrat na dan: metformin
c/mL to ≤500,000 c/mL. 
≤ 50.000 kopij/ml > 50.000 kopij/ml
Monitoring of liver biochemistries is recommended in patients with hepatitis B and/or C co-infection. 
Pri bolnikih, ki so sočasno okuženi tudi s hepatitisom B in/ali C, je priporočljivo spremljati biokemijske vrednosti jetrnih testov.
In the presence of integrase inhibitor resistance, there are insufficient data to recommend a dose for dolutegravir in adolescents. 
Pri prisotni odpornosti na zdravila iz skupine zaviralcev integraze se priporoča jemanje zdravila Tivicay med jedjo, da se poveča izpostavljenost
Patients with prior treatment failure, but not exposed to the integrase class In the international multicentre, double-blind SAILING study (ING111762), 719 HIV-1 infected, antiretroviral therapy (ART)-experienced adults were randomized and received either dolutegravir 50 mg once daily or raltegravir 400 mg twice daily with investigator selected background regimen consisting of up to 2 agents (including at least one fully active agent). 
V mednarodni, multicentrični, dvojno slepi študiji SAILING (ING111762) je bilo 719 odraslih, okuženih z virusom HIV, ki so že prejemali protiretrovirusno terapijo (ART), randomiziranih v skupino, ki je prejemala 50 mg dolutegravirja enkrat na dan, ali v skupino, ki je prejemala 400 mg raltegravirja dvakrat na dan,
Each film-coated tablet contains dolutegravir sodium equivalent to 50 mg dolutegravir. 
Ena filmsko obložena tableta vsebuje 50 mg dolutegravirja (v obliki natrijeve soli).
Dolutegravir ↓ AUC ↓ 54% Cmax ↓ 57% C24 ↓ 56% (Complex binding to polyvalent ions) 
Železovi dodatki dolutegravir ↓ AUC ↓ 54% Cmax ↓ 57% C24 ↓ 56%
Skin and subcutaneous tissue disorders 
Bolezni kože in podkožja pogosti izpuščaj pogosti srbečica
Uncommon side effects These may affect up to 1 in 100 people: 
Ti se lahko pojavijo pri največ 1 od 100 bolnikov:
Don't take Tivicay: 
Ne jemljite zdravila Tivicay z naslednjimi zdravili:
MARKETING AUTHORISATION NUMBER(S) EU/1/13/892/003 
ŠTEVILKA (ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET Z ZDRAVILOM EU/1/13/892/003
• insomnia 
• tesnoba
Uncommon Suicidal ideation*, suicide attempt* 
Psihiatrične motnje pogosti nespečnost pogosti nenormalne sanje pogosti depresija pogosti anksioznost občasni samomorilne misli*, poskus samomora*
In paediatric patients the weight-based once daily dose should 
Pri pediatričnih bolnikih je treba na podlagi telesne mase določeni dnevni odmerek podvojiti,
A single dose of 50 mg of dolutegravir was administered to 8 subjects with moderate hepatic impairment (Child-Pugh class B) and to 8 matched healthy adult controls. 
Pugh B) in 8 usklajenih zdravih odraslih primerjalnih oseb, je prejelo enkratni odmerek 50 mg dolutegravirja.
In the presence of integrase class resistance, Tivicay should preferably be taken with food to enhance exposure (particularly in patients with Q148 mutations) (see section 5.2). 
(zlasti pri bolnikih z mutacijami Q148) (glejte poglavje 5.2).
NAME OF THE MEDICINAL PRODUCT Tivicay 25 mg film-coated tablets dolutegravir 
Tivicay 25 mg filmsko obložene tablete dolutegravir
Marketing Authorisation Holder ViiV Healthcare BV Huis ter Heideweg 62 
Imetnik dovoljenja za promet z zdravilom ViiV Healthcare BV
Efavirenz ↔ (historical controls) (induction of UGT1A1 and CYP3A enzymes) 
etravirin ↔ (indukcija encimov UGT1A1 in CYP3A)
Dolutegravir ↓ AUC ↓ 54% Cmax ↓ 43% Cτ ↓72% (induction of UGT1A1 and CYP3A enzymes) 
Učinkovine za zdravljenje infekcij z mikobakterijami rifampicin dolutegravir ↓ AUC ↓ 54% Cmax ↓ 43% Cτ ↓ 72% (indukcija encimov UGT1A1 in CYP3A)
Other agents Antiarrhythmics Dofetilide 
Druga zdravila in zdravilo Tivicay
NAME OF THE MEDICINAL PRODUCT Tivicay 50 mg film-coated tablets dolutegravir 
Tivicay 50 mg filmsko obložene tablete dolutegravir
NAME OF THE MEDICINAL PRODUCT Tivicay 10 mg film-coated tablets dolutegravir 
Tivicay 10 mg filmsko obložene tablete dolutegravir
Dolutegravir ↓ AUC ↓ 33% Cmax ↓ 35% C24 ↓ 32% (Complex binding to polyvalent ions) 
Multivitaminski pripravki dolutegravir↓ AUC ↓ 33% Cmax ↓ 35% C24 ↓ 32%
Therefore, Tivicay is recommended to be taken with food by patients infected with HIV with integrase class resistance (see section 4.2). 
Zaradi tega se pri bolnikih z okužbo HIV in odpornostjo na zdravila iz skupine zaviralcev integraze priporoča jemanje zdravila Tivicay skupaj s hrano
Do not swallow the desiccant. 
Pazite, da ne pogoltnete sušilnega sredstva.
• if they have been taking combination therapy for a long time 
Verjetnost za pojav te bolezni je večja pri posameznikih: • ki jemljejo kombinirano terapijo dalj časa,
AUC ↓ 49% Cmax ↓ 33% Cτ ↓ 73% 
Antikonvulzivi karbamazepin dolutegravir ↓ AUC ↓ 49 % Cmax ↓ 33 % Cτ ↓ 73 %
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING BOTTLE LABEL 25 mg film-coated tablets 
PODATKI NA PRIMARNI OVOJNINI NALEPKA NA VSEBNIKU 25 mg filmsko obložene tablete
The recommended adult dose of dolutegravir is 50 mg twice daily when co-administered with these metabolic inducers. 
Priporočeni odmerek dolutegravirja za odrasle med sočasno uporabo s temi induktorji presnove je 50 mg dvakrat na dan.
• being sick (vomiting) 
• slabost s siljenjem na bruhanje (navzea)
The recommended adult dose of dolutegravir is 50 mg twice daily when co-administered with etravirine without boosted protease inhibitors. 
Priporočeni odmerek dolutegravirja za odrasle med sočasno uporabo z etravirinom (brez okrepljenih zaviralcev proteaz) je 50 mg dvakrat na dan.
NAME OF THE MEDICINAL PRODUCT Tivicay 10 mg film-coated tablets 
PODATKI NA ZUNANJI OVOJNINI ŠKATLA 10 mg filmsko obložene tablete
HIV-1 RNA <50 copies/mL by baseline covariates 
HIV-1 RNA < 50 kopij/ml po izhodiščnih sospremenljivkah Izhodiščno virusno breme
Uncommon Hepatitis Rare 
Redki neželeni učinki
- Keep this leaflet. 
(glejte Preglednico 2).
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON 50mg film-coated tablets 
PODATKI NA ZUNANJI OVOJNINI ŠKATLA 50 mg filmsko obložene tablete
Integrase class resistance of particular concern 
Protivirusno delovanje v kombinaciji z drugimi protivirusnimi sredstvi
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON 25mg film-coated tablets 
PODATKI NA ZUNANJI OVOJNINI ŠKATLA 25 mg filmsko obložene tablete
blister (PVC/PVDC/alu) 50 x 1 tablets (unit dose) 
Filmsko obložena tableta
In the meantime, the applicant withdrew the application in the Netherlands. 
V tem času je predlagatelj umaknil svojo vlogo na Nizozemskem.
Whereas 
Ob upoštevanju naslednjega
The decentralised procedure PT/H/1256/001/DC started on 04 June 2014. 
Decentralizirani postopek PT/H/1256/001/DC se je začel 4. junija 2014.
The application was submitted to the reference Member State (RMS): Portugal and the concerned Member States (CMS): Germany, Netherlands and United Kingdom. 
Vloga je bila predložena v referenčni državi članici: na Portugalskem in v zadevnih državah članicah: Nemčiji, na Nizozemskem in v Združenem kraljestvu.
• The Committee considered the referral under Article 29(4) of Directive 2001/83/EC. 
• odbor je obravnaval napotitev v skladu s členom 29(4) Direktive 2001/83/ES;
• The Committee considered the totality of the data submitted by the applicant in relation to the objections raised as potential serious risk to public health. 
• odbor je proučil podatke, ki jih je predložil predlagatelj v odziv na zadržke glede morebitnih resnih tveganj za javno zdravje;
The reference medicinal product (Taxol) has a complex formulation for which it is known that the micellar formulation affects the pharmacokinetic profile of paclitaxel after intravenous administration. 
Referenčno zdravilo (Taxol) ima kompleksno formulacijo, v zvezi s katero je znano, da micelarna formulacija vpliva na farmakokinetični profil paklitaksela po intravenski uporabi.
Day 60 of the CMDh procedure was on 29 March 2018 and as no agreement could be reached the procedure was referred to the CHMP. 
60. dan postopka CMDh je nastopil 29. marca 2018 in ker ni bilo doseženo soglasje, je bila zadeva napotena na odbor CHMP.
On 29 March 2018 Portugal therefore triggered a referral under Article 29(4) of Directive 2001/83/EC. 
Tako je Portugalska 29. marca 2018 sprožila napotitev v skladu s členom 29(4) Direktive 2001/83/ES.
The CMDh 60 day procedure was initiated on 29 January 2018. 
60-dnevni rok za izvedbo postopka skupine CMDh je začel teči 29. januarja 2018.
On day 210, major issues on bioequivalence, raised by the Netherlands, remained unresolved; hence the procedure was referred to the Coordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh), under Article 29, paragraph 1 of Directive 2001/83/EC, by Portugal on 02 November 2017. 
Na 210. dan postopka so bistveni zadržki v zvezi z bioekvivalenco, ki jih je izpostavila Nizozemska, ostali nerazrešeni, zato je Portugalska 2. novembra 2017 zadevo napotila na skupino za usklajevanje za postopek z medsebojnim priznavanjem in decentralizirani postopek - zdravila v humani medicini (CMDh) v skladu s členom 29(1) Direktive 2001/83/ES.
The applicant submitted a study report with results of the direct comparison of micelles' characteristics of Paclitaxel Hetero and Taxol and another publication containing data on the free drug fraction of Taxol in human plasma. 
Predlagatelj je predložil poročilo o študiji z rezultati neposredne primerjave značilnosti micelov v zdravilu Paclitaxel Hetero in zdravilu Taxol ter druge publikacije s podatki o prosti frakciji zdravila Taxol v človeški plazmi.
The CHMP considered that it is essential in order to waive the bioequivalence study requirement to establish that the generic medicinal product and the reference medicinal product have the same behaviour in plasma and ultimately in vivo, i.e. a direct comparison of the free fraction between the two medicinal products should be considered in line with the “Reflection paper on the pharmaceutical development of intravenous medicinal products containing active substances solubilised in micellar systems” (EMA/CHMP/QWP/799402/2011 
Odbor CHMP je menil, da je za opustitev izvedbe študij bioekvivalence treba ugotoviti, ali se generično in referenčno zdravilo obnašata enako v plazmi in nazadnje tudi in vivo, tj. neposredno primerjati prosto frakcijo obeh zdravil v skladu z “Razpravo o farmacevtskem razvoju zdravil za intravensko uporabo, ki vsebujejo učinkovino, topno v micelarnih sistemih” (EMA/CHMP/QWP/799402/2011)
In such case, in principle a biowaiver of in vivo bioequivalence study is only possible when there are adequate in vitro data to demonstrate similarity between generic and reference medicinal product. 
V takšnem primeru je opustitev izvedbe študij bioekvivalence in vivo načeloma možna le, če so na voljo ustrezni podatki in vitro, ki izkazujejo podobnost med generičnim in referenčnim zdravilom.
An application was submitted under the decentralised procedure for Paclitaxel Hetero, 6 mg/mL, concentrate for solution for infusion on 15 May 2014. 
Dne 15. maja 2014 je bila v okviru decentraliziranega postopka predložena vloga za pridobitev dovoljenja za promet z zdravilom Paclitaxel Hetero, 6 mg/ml, koncentrat za raztopino za infundiranje.
However, the additional data provided were not robust enough to establish equivalence between Paclitaxel Hetero and the EU reference medicinal product. 
Toda dodatni predloženi podatki niso bili dovolj trdni, da bi lahko potrdili ekvivalentnost med zdravilom Paclitaxel Hetero in referenčnim zdravilom EU.
While there may be occasions where an indirect comparison may be acceptable to support a biowaiver, having assessed the literature provided, the CHMP concluded that the data was not sufficiently robust nor convincing enough to replace the need for a head-to-head comparison using identical methods and performed at the same time for test and reference product, and therefore should be understood as supportive only. 
Medtem ko obstajajo določeni primeri, kadar se lahko posredna primerjava uporabi v podporo opustitvi izvedbe študij bioekvivalence, je odbor CHMP na podlagi proučitve predložene literature zaključil, da vsebovani podatki niso niti dovolj trdni niti dovolj prepričljivi, da bi lahko nadomestili potrebo po neposredni primerjavi ob uporabi identičnih metod, izvedenih sočasno za testno in referenčno zdravilo, zato jih je treba razumeti le kot podporne podatke.
Therefore, the Committee recommends the refusal of the marketing authorisation of Paclitaxel Hetero in the reference and concerned Member States. 
Odbor tako priporoča zavrnitev vloge za pridobitev dovoljenja za promet z zdravilom Paclitaxel Hetero v referenčni državi članici in zadevnih državah članicah.
The Netherlands raised objections on the fact that the indirect comparison data on which the applicant based its claim for equivalence was not considered robust nor was convincing enough to support a biowaiver, and this was regarded to be a potential serious risk to public health. 
Nizozemska je izrazila zadržek zaradi tega, ker posredna primerjava podatkov, na kateri je predlagatelj zasnoval svojo zahtevo za priznanje bioekvivalence, ni dovolj trdna in prepričljiva, da bi lahko ustrezno podprla opustitev izvedbe študij bioekvivalence, kar pomeni morebitno resno tveganje za javno zdravje.
The CHMP considered, as a consequence, that the benefit-risk balance of Paclitaxel Hetero is not favourable. 
Zato je odbor CHMP menil, da razmerje med koristmi in tveganji zdravila Paclitaxel Hetero ni ugodno.
• The Committee considered that the data available was insufficient to establish equivalence between Paclitaxel Hetero and the EU reference medicinal product. 
• odbor je menil, da razpoložljivi podatki niso bili zadostni za potrditev ekvivalentnosti med zdravilom Paclitaxel Hetero in referenčnim zdravilom EU; je odbor presodil, da razmerje med koristmi in tveganji zdravila Paclitaxel Hetero ni ugodno.
This may be repeated up to six times. 
To bo morda treba ponoviti do šestkrat.
Duration of PV (months)* 
Trajanje PV (meseci)*
• Wash your hands before you begin. 
• Preden začnete, si umijte roke.
Do not apply further force. 
Ne poskušajte z uporabo dodatne sile.
These elevations were mostly transient and occurred during the first treatment year. 
Ta zvišanja so bila predvsem prehodna in so se pojavila med prvim letom zdravljenja.
Do not point towards your face or anyone else's face. 
Peresnika ne usmerjajte v smer svojega obraza ali obraza katere koli druge osebe.
Patients recovered from the two events, one event was ongoing at the time of assessment. 
Bolniki so po dveh dogodkih okrevali, en dogodek pa je v času ocene še potekal.
very rare blindness# 
zelo redki slepota#
Do not use the pen if it appears damaged. 
Ne uporabljajte peresnika, če je videti poškodovan.
If you are injecting this medicine yourself, you will get clear instructions on how to prepare and inject it. 
Če si zdravilo injicirate sami, boste prejeli jasna navodila, kako ga pripraviti in injicirati.
Opened date: 
Datum odprtja:
Thus, no valid estimation of the absolute bioavailability could be done. 
Zato ni mogoče podati veljavne ocene absolutne biološke uporabnosti.
Empty pens must never be reused and must be properly discarded. 
Praznih peresnikov se nikoli ne sme ponovno uporabiti in jih je treba pravilno zavreči.
Your doctor will tell you the dose you need. 
Zdravnik vam bo povedal, kakšen odmerek potrebujete.
After 36 months of treatment, the complete haematological response was 70.5%. 
Po 36 mesecih zdravljenja je bil popoln hematološki odziv 70,5 %.
- if you have severe kidney disease (with your kidneys working at less than 15% of their normal ability). 
- če imate hudo bolezen ledvic (vaše ledvice delajo z manj kot 15 % normalne zmožnosti).
Your doctor will usually check your vision before starting your treatment. 
Zdravnik bo pred začetkom zdravljenja običajno preveril vaš vid.
It will need a certain time to reach your individual optimal dose of Besremi. 
Potrebno bo nekaj časa, da bo dosežen vaš individualni optimalni odmerek zdravila Besremi.
Characteristics of the study population are presented in Table 2. 
Značilnosti populacije v študiji so predstavljene v Preglednici 2.
Presence of splenomegaly 
Prisotnost splenomegalije
Effects on fertility was not assessed. 
Učinkov na plodnost niso vrednotili.
The clicking sounds will stop when the injection is complete. 
Klikajoči zvoki bodo prenehali, ko bo injiciranje končano.
A higher than proportional increase in exposure was observed. 
Opazili so izpostavljenost, ki je bila več kot sorazmerna.
Needles must be discarded immediately after use. 
Igle je treba zavreči takoj po uporabi.
During the titration phase the efficacy to reduce the cardiovascular and thromboembolic risk of the underlying disease may not be fully established. 
Med fazo titracije učinkovitost za zmanjšanje srčno-žilnega in trombemboličnega tveganja obstoječe bolezni morda ni v celoti vzpostavljena.
Instead, get a new pen. 
Namesto tega si priskrbite nov peresnik.
• Note: The blue protective sleeve locks automatically and the now visible red locking indicator covers the needle for your protection. 
• Opomba: moder zaščitni tulec se avtomatsko zaskoči in sedaj vidni rdeči indikator zaklepa prekrije iglo za vašo zaščito.
After that, the dose may be adapted and/or the administration interval prolonged up to every four weeks, as appropriate for the patient. 
Nato se odmerek lahko prilagodi in/ali interval odmerjanja podaljša do odmerjanja na vsake štiri tedne, kot je za bolnika primerno.