natgillin/translations-raw huggingface dataset:
The efficacy of tocilizumab for the treatment of active sJIA was assessed in a 12 week randomised, double blind, placebo-controlled, parallel group, two arm study.
Učinkovitost tocilizumaba za zdravljenje aktivnega sJIA so ocenili v 12-tedenski, randomizirani, dvojno slepi, s placebom primerjani študiji z vzporednima skupinama in dvema rokama.
The efficacy of Tracleer has not been established in patients with severe pulmonary arterial hypertension.
Učinkovitost zdravila Tracleer pri bolnikih s hudo pljučno arterijsko hipertenzijo ni bila ugotovljena.
The efficacy of Triumeq in HIV-infected, therapy naive subjects is based on the analyses of data from two randomized, international, double-blind, active-controlled trials, SINGLE (ING114467) and SPRING-2 (ING113086) and the international, open-label, active-controlled trial FLAMINGO (ING114915).
Učinkovitost zdravila Triumeq pri predhodno nezdravljenih osebah, okuženih z virusom HIV, temelji na analizi podatkov iz dveh randomiziranih, mednarodnih, dvojno slepih, aktivno nadzorovanih študij: SINGLE (ING114467) in SPRING-2 (ING113086) ter mednarodnega, odprtega, aktivno nadzorovanega preskušanja FLAMINGO (ING114915).
The efficacy of ustekinumab was studied in 110 paediatric patients aged 12 to 17 years with moderate to severe plaque psoriasis in a multicenter, Phase 3, randomised, double blind, placebo controlled study (CADMUS).
Učinkovitost ustekinumaba so preučevali v multicentrični, randomizirani, dvojno slepi s placebom nadzorovani študiji faze 3 (CADMUS) pri 110 pediatričnih bolnikih z zmerno do hudo psoriazo s plaki, starih 12 do 17 let.
The efficacy of varenicline was confirmed in a randomised placebo-controlled trial in 525 subjects with a history of major depression in the past two years or under current stable treatment.
Učinkovitost vareniklina so potrdili v randomiziranem, s placebom nadzorovanem preskušanju pri 525 preiskovancih, ki so imeli hudo depresijo v anamnezi v zadnjih dveh letih ali so bili trenutno stabilno zdravljeni.
The efficacy of varenicline was confirmed in a randomised placebo-controlled trial of 525 subjects with a history of major depression in the past two years or under current stable treatment.
Učinkovitost vareniklina so potrdili v randomiziranem, s placebom nadzorovanem preskušanju pri 525 preiskovancih, ki so imeli hudo depresijo v anamnezi v zadnjih dveh letih ali so bili trenutno stabilno zdravljeni.
The efficacy of Vectibix as monotherapy in patients with metastatic colorectal cancer (mCRC) who had disease progression during or after prior chemotherapy was studied in open-label, single-arm trials (585 patients) and in two randomised controlled trials versus best supportive care (463 patients) and versus cetuximab (1,010 patients).
Učinkovitost zdravila Vectibix v monoterapiji pri bolnikih z metastatskim kolorektalnim rakom (mKRR), ki jim je bolezen napredovala med predhodno kemoterapijo ali po njej, so raziskali v odprtih preskušanjih z enim krakom (585 bolnikov) in v dveh randomiziranih kontroliranih preskušanjih v primerjavi z najboljšo podporno oskrbo (463 bolnikov) in v primerjavi s cetuksimabom (1.010 bolnikov).
The efficacy of Vectibix in combination with oxaliplatin, 5-fluorouracil (5-FU), and leucovorin (FOLFOX) was evaluated in a randomised, controlled trial of 1,183 patients with mCRC with the primary endpoint of PFS.
Učinkovitost zdravila Vectibix v kombinaciji z oksaliplatinom, 5-fluorouracilom (5-FU) in levkovorinom (FOLFOX) so ocenili v randomiziranem, kontroliranem preskušanju pri 1.183 bolnikih z mKRR, v katerem je bil primarni opazovani dogodek PFS.
The efficacy of Viekirax in patients previously exposed to Viekirax, or to medicinal products of the same classes as those of Viekirax (NS3/4A inhibitors or NS5A inhibitors), has not been demonstrated.
Učinkovitost zdravila Viekirax ni dokazana pri bolnikih, ki so bili predhodno izpostavljeni zdravilu Viekirax ali zdravilom iz iste skupine, v katero spada zdravilo Viekirax (zaviralci NS3/4A ali zaviralci NS5A).
The efficacy of Vimpat as adjunctive therapy at recommended doses (200 mg/day, 400 mg/day) was established in 3 multicenter, randomized, placebo-controlled clinical trials with a 12-week maintenance period.
Učinkovitost dodatnega zdravljenja z zdravilom Vimpat v priporočenih odmerkih (200 mg/dan, 400 mg/dan) so preučevali v 3 multicentričnih, randomiziranih, s placebom nadzorovanih kliničnih preskušanjih z 12-tedenskim obdobjem vzdrževalnega zdravljenja.
The efficacy of Vimpat as adjunctive therapy at recommended doses (200 mg/day, 400 mg/day) was established in 3 multicenter, randomized, placebo-controlled clinical trials with a 12-week maintenance period.
Učinkovitost dopolnilnega zdravljenja z zdravilom Vimpat v priporočenih odmerkih (200 mg/dan, 400 mg/dan) so preučevali v 3 multicentričnih, randomiziranih, s placebom nadzorovanih kliničnih preskušanjih z 12-tedenskim obdobjem vzdrževalnega zdravljenja.
The efficacy of Xeplion in maintaining symptomatic control and delaying relapse of schizophrenia was established in a longer-term double-blind, placebo-controlled, flexible-dose study involving 849 non-elderly adult subjects who met DSM-IV criteria for schizophrenia.
Učinkovitost zdravila Xeplion pri vzdrževanju nadzora simptomov in zakasnitvi relapsa shizofrenije so ugotovili v dolgotrajni, dvojno slepi, s placebom nadzorovani študiji s spremenljivim odmerkom, v kateri je sodelovalo 849 odraslih (starostniki niso bili vključeni), ki so izpolnjevali merila za shizofrenijo DSM-IV.
The efficacy of Xiapex 0.58 mg was evaluated in two pivotal randomized, double-blind, placebo- controlled studies, CORD I (AUX-CC-857) and CORD II (AUX-CC-859), in adult patients with Dupuytren’s contracture.
Učinkovitost zdravila Xiapex 0,58 mg je bila ovrednotena v dveh ključnih randomiziranih, dvojno slepih, s placebom nadzorovanih študijah, CORD I (AUX-CC-857) in CORD II (AUX-CC-859), pri odraslih bolnikih z Dupuytrenovo kontrakturo.
The efficacy profile in AOSD patients is expected to be similar to SJIA patients based on literature reports.
Po podatkih poročil iz literature je pri bolnikih z AOSD mogoče pričakovati podoben profil učinkovitosti kot pri bolnikih s SJIA.
The efficacy results are presented in Table 15
Rezultati učinkovitosti so predstavljeni v preglednici 15.
The efficacy results are presented in Table 2.
Rezultate o učinkovitosti prikazuje preglednica 2.
The efficacy results are presented in Table 3.
Rezultati o učinkovitosti so prikazani v preglednici 3.
The efficacy results are provided in Figure 1, Tables 5 and 6.
Podatki o učinkovitosti so prikazani na sliki 1 ter navedeni v preglednicah 5 in 6.
The efficacy results are summarized in Figure 1 (LUX-Lung 3) and Tables 5 and 6 (LUX-Lung 3 and 6).
Podatki o učinkovitosti so povzeti na sliki 1 (LUX-Lung 3) ter navedeni v preglednicah 5 in 6 (LUX-Lung 3 in 6).
The efficacy results are summarized in Table 5.
Rezultati o učinkovitosti so povzeti v preglednici 5.
The efficacy results at the event-triggered analysis were 94.3% (96.1% CI: 91.5;96.3) against 6-month persistent infection and 91.4% (96.1% CI: 89.4;95.4) against 12-month persistent infection.
Z dogodki prožena analiza je pokazala učinkovitost 94,3 % (96,1 % IZ: 91,5; 96,3) proti 6-mesečni persistentni okužbi in 91,4 % (96.1 % IZ: 89,4; 95,4) proti 12-mesečni persistentni okužbi.
The efficacy results at the time of the primary analysis of OS including all randomized patients are summarized in Figure 2 and Table 8.
Podatki o učinkovitosti v času primarne analize skupnega preživetja vključno z vsemi naključno izbranimi bolniki so povzeti na sliki 2 ter navedeni v preglednici 8.
The efficacy results for AP (minimum follow-up 12 months and median treatment duration of months) and BP (minimum follow-up 18 months and median treatment duration of 2.8 months) Ph+ CML patients are present in Table 3.
Rezultati o učinkovitosti pri bolnikih s Ph+ KML v pospešeni fazi (minimalno obdobje spremljanja 12 mesecev in mediana trajanja zdravljenja 10 mesecev) ter pri bolnikih s Ph+ KML v blastni fazi (minimalno obdobje spremljanja 18 mesecev in mediana trajanja zdravljenja 2,8 meseca) so predstavljeni v preglednici 3.
The efficacy results for the primary endpoint were obtained from the final PFS analysis (see Table 6 and Figure 3).
Rezultati učinkovitosti glede primarnega cilja opazovanja izhajajo iz končne analize preživetja brez napredovanja bolezni (glejte preglednico 6 in sliko 3).
The efficacy results from the CLEOPATRA study are summarised in Table 2.
Rezultati učinkovitosti študije CLEOPATRA so povzeti v preglednici 2.
The efficacy results from the monotherapy and combination therapy studies are summarised in Table 4:
Preglednica 4 navaja rezultate učinkovitosti iz študij monoterapije in kombiniranega zdravljenja.
The efficacy results from the non-comparative monotherapy and combination therapy studies are summarised in Table 4:
Preglednica 4 navaja rezultate učinkovitosti monoterapije in kombiniranega zdravljenja iz študij brez primerjalne skupine.
The efficacy results from the non-comparative monotherapy and combination therapy studies are summarised in Table 5:
Preglednica 5 navaja rezultate učinkovitosti monoterapije in kombiniranega zdravljenja iz študij brez primerjalne skupine.
The efficacy results in the primary efficacy population were consistent with those in the ITT population; therefore, only the efficacy data for the ITT population are presented in Table 8.
Rezultati učinkovitost v primarni populaciji učinkovitosti so se skladali z rezultati v populaciji ZNZ, zato so v preglednici 8 predstavljeni le podatki o učinkovitosti za populacijo ZNZ.
The efficacy was assessed in a randomised, double-blinded, placebo-controlled study in 94 patients with fistulising Crohn’s disease who had fistulae that were of at least 3 months’ duration.
Učinkovitost zdravila so ocenjevali tudi v randomizirani, dvojno slepi s placebom kontrolirani študiji pri 94 bolnikih s Crohnovo boleznijo s fistulami, ki so trajale najmanj 3 mesece.
The efficacy was assessed in a randomised, double-blinded, placebo-controlled study in 94 patients with fistulising Crohn’s disease who had fistulae that were of at least 3 months’ duration.
Učinkovitost zdravila so ocenjevali tudi v randomizirani, dvojno slepi, s placebom kontrolirani študiji pri 94 bolnikih s Crohnovo boleznijo s fistulami, ki so trajale najmanj 3 mesece.
The efficacy was similar across all of the subgroups examined, including in patients with and without deletion 17p, a pre-specified stratification factor (Table 6).
Učinkovitost je bila podobna v vseh preiskovanih podskupinah, vključno z bolniki z delecijo 17p oziroma brez nje, kar je bil vnaprej določen dejavnik za stratifikacijo (preglednica 6).
The Efron method was used for correction for tied events. cData cutoff date = 31 Jul 2015
Efronova metoda je bila uporabljena za popravek povezanih dogodkov. cDatum zaključka zbiranja podatkov = 31. julij 2015.
The eighth study looked at the effect of adding Abilify or placebo to existing treatment with lithium or valproate (another antipsychotic medicine) in 384 adults.
V osmi študiji so pri 384 odraslih proučevali učinek dodajanja zdravila Abilify ali placeba obstoječemu zdravljenju z litijem ali valproatom (drugim antipsihotičnim zdravilom).
The elderly and patients with hepatic or renal impairment
Starejši in bolniki z jetrno ali ledvično okvaro
The elderly population has been studied in clinical studies.
Dajanje zdravila starejši populaciji so preučili v kliničnih študijah.
The elderly population has been studied in clinical studies.
Starejšo populacijo so preučili v kliničnih študijah.
The electronic injection device used with the cartridges is programmed to deliver the correct doses of Rebif at the start of treatment and during the standard-dose phase.
Električna naprava za injiciranje, ki se uporablja z vložki, je programirana tako, da odmeri pravilne odmerke zdravila Rebif na začetku zdravljenja in med fazo prejemanja standardnega odmerka.
The elimination half- life was 22 ± 9 hours.
Razpolovni čas je bil 22 ± 9 ur.
The elimination half-life (t1⁄2) is 40-50 minutes.
Razpolovni čas izločanja (t1⁄2) je 40–50 minut.
The elimination half-life (t½) is 40-50 minutes.
Razpolovni čas izločanja (t½) je 40–50 minut.
The elimination half-life (t½) is approximately 3–6 hours.
Razpolovni čas izločanja (t½) je približno 3 – 6 ur.
The elimination half-life after intravenous administration of methoxy polyethylene glycol-epoetin beta is 134 hours
Razpolovni čas izločanja po intravenskem vnosu metoksipolietilenglikol epoetina beta znaša 134 ur.
The elimination half-life after intravenous administration of methoxy polyethylene glycol-epoetin beta is 134 hours.
Razpolovni čas izločanja po intravenskem vnosu metoksipolietilenglikol epoetina beta znaša 134 ur.
The elimination half-life averaged 9.3 hours.
Razpolovni čas izločanja znaša približno 9,3 ure.
The elimination half-life from the plasma was between 1 and 6 days and appeared to be unaffected by the dose.
Razpolovna doba izločanja iz plazme je bila od 1 do 6 dni in zdi se, da ni bila odvisna od odmerka.
The elimination half-life is about 2−3 hours after intravenous administration.
Po intravenskem odmerjanju je razpolovni čas izločanja približno 2–3 ure.
The elimination half-life is not changed in patients with renal impairment.
Razpolovna doba izločanja pri bolnikih z ledvično okvaro ni spremenjena.
The elimination half-life of 6–mercaptopurine is 90 ± 30 minutes, but the active metabolites have a longer half-life (approximately 5 hours) than the parent compound.
Eliminacijski razpolovni čas 6-merkaptopurina je 90 ± 30 minut, vendar je pri aktivnih presnovkih razpolovni čas daljši (približno 5 ur) kot pri matični spojini.
The elimination half-life of bosutinib in subjects with renal impairment was similar to that in healthy subjects.
Pri preiskovancih z okvaro ledvic je bil razpolovni čas izločanja bosutiniba podoben kot pri zdravih preiskovancih.
The elimination half-life of glimepiride is approximately 5 to 8 h.
Razpolovni čas izločanja glimepirida je približno 5 do 8 ur.
The elimination half-life of glycopyrronium appears to be dependent on route of administration being
Zdi se, da je razpolovna doba izločanja glikopironija odvisna od poti uporabe, saj je znašala
The elimination half-life of telmisartan is not changed in patients with hepatic impairment.
Razpolovna doba izločanja se pri bolnikih z jetrno okvaro ne spremeni.
The elimination half-life of the two-ring opened metabolite ADR-925 is not given in literature.
Razpolovni čas izločanja odprtega presnovka z dvema obročema ADR- 925 v literaturi ni objavljen.
The elimination half-life of the unchanged drug is approximately 13 hours.
Biološka razpolovna doba izločanja nespremenjenega zdravila je približno 13 ur.
The elimination half-life was dose dependent and ranged from 45 to 100 minutes.
Razpolovni čas izločanja je bil odvisen od odmerka in je bil od 45 do 100 minut.
The elimination half-life, determined after intravenous administration, was approximately 45 minutes; the total blood clearance was 1.5 1/hr/kg.
Po intravenskem dajanju je bila razpolovna doba izločanja približno 45 minut; popoln očistek krvi je bil 1,5 l/h/kg.
The elimination of ataluren is likely dependent on hepatic and intestinal glucuronidation of ataluren followed by renal excretion of the resulting glucuronide metabolite.
Izločanje atalurena je verjetno odvisno od glukuronidacije atalurena v jetrih in črevesju, ki ji sledi izločitev nastalega glukuronidnega presnovka skozi ledvice.
The elimination of pramipexole is dependent on renal function.
Izločanje pramipeksola je odvisno od delovanja ledvic.
The elimination of pramipexole is dependent on renal function.
Izločanje pramipeksola je odvisno od ledvičnega delovanja.
The elimination of topotecan has only been partly investigated in man.
Izločanje topotekana je pri človeku le delno raziskano.
The elimination of topotecan has only been partly investigated in man.
Izločanje topotekana pri človeku je le delno raziskano.
The elimination of unchanged cysteamine in the urine has been shown to range between 0.3 % and 1.7% of the total daily dose in four patients; the bulk of cysteamine is excreted as sulphate.
Pri štirih bolnikih se je izločanje cisteamina v nespremenjeni obliki z urinom gibalo med 0,3 % in 1,7 % celotnega dnevnega odmerka; večina cisteamina se izloča v obliki sulfata.
The elimination t1/2 after intravenous administration of clomipramine hydrochloride in dogs was 6.4 hours for clomipramine and 3.6 hours for desmethylclomipramine.
Razpolovni čas izločanja (t1/2) po intravenskem dajanju znaša pri psih 6.4 ure za klomipramin in 3.6 ure za desmetilklomipramin.
The elimination t1/2 following intravenous dosing was approximately 4.9 h.
Razpolovni čas izločanja po intravenskem odmerjanju je bil približno 4,9 h.
The Ellipta device itself is a light grey inhaler with a yellow mouthpiece cover and a dose counter.
Pripomoček Ellipta je svetlo siv inhalator z rumenim pokrovčkom ustnika in števcem odmerkov.
The Ellipta inhaler itself consists of a grey plastic body, a light green mouthpiece cover and a dose counter.
Inhalator Ellipta je sestavljen iz svetlo sivega plastičnega ohišja, zelenega pokrovčka ustnika in števca odmerkov.
The emergence of HACA was not associated with clinical deterioration or with an increased risk of reactions to subsequent infusions in the majority of patients.
Pojav HACA pri večini bolnikov ni bil povezan s kliničnim poslabšanjem ali povečanim tveganjem za reakcije pri nadaljnjih infuzijah.
The emergence of thought disorders and/or behavioural abnormalities when patients are treated with sodium oxybate requires careful and immediate evaluation.
Če se pri bolnikih, ki se zdravijo z natrijevim oksibatom, pojavijo motnje mišljenja in/ali nenormalno vedenje, je treba njihovo stanje natančno in takoj ovrednotiti.
The Empliciti infusion solution should be used immediately.
Empliciti raztopino za infundiranje je treba uporabiti takoj.
The empty, sterile vial is intended to be used for mixing the concentrate and solvent.
Prazna, sterilna viala je namenjena za mešanje koncentrata in vehikla.
The emulsion contains an ‘adjuvant’ (a compound containing oil) to enhance the immune response.
Cepivo vsebuje tudi „adjuvans“ (spojino, ki vsebuje olje) za povečanje imunskega odziva.
The emulsion contains an ‘adjuvant’ (a compound containing oil) to stimulate a better response.
Emulzija vsebuje tudi „adjuvans“ (spojino, ki vsebuje olje) za stimulacijo boljšega odziva.
The emulsion contains the ‘adjuvant’ to enhance the immune response.
Emulzija vsebuje adjuvans za povečanje imunskega odziva.
The emulsion is white, opaque.
Emulzija je bela in motna.
The emulsion presents as a whitish appearance
Emulzija je belkastega videza.
The Enbrel pre-filled pen is available in a 50 mg strength.
Napolnjeni injekcijski peresnik Enbrel je na voljo v jakosti 50 mg.
The enclosed cannula is attached to the Removab pre-filled syringe.
Priloženo kanilo nataknite na injekcijsko brizgo, napolnjeno z zdravilom Removab.
The enclosed package leaflet contains additional information for healthcare professionals
Priloženo navodilo za uporabo vsebuje dodatne informacije za zdravstveno osebje.
The end-user may remove the medicinal product from refrigeration for storage at a temperature not above 30°C for one single period of 1 month.
Končni uporabnik lahko zdravilo vzame iz hladilnika in ga hrani pri temperaturi do 30 °C za enkratno obdobje 1 meseca.
The endometrial cancer risk is about 5 in every 1,000 women with a uterus not using HRT.
Tveganje za raka endometrija pri ženskah, ki imajo maternico in ki ne uporabljajo HNZ, je približno 5 na 1.000 žensk.
The enrolled population was moderately PI-experienced with more than half of patients having never received prior PI and around 80% of patients presenting a viral strain with less than 3 PI mutations.
Vključena populacija je bila zmerno izkušena z zaviralci proteaz: več kot polovica bolnikov ni še nikoli prej dobivalo zaviralce proteaz in približno 80% bolnikov je imelo virusni sev z manj kot tremi mutacijami, povezanimi z zaviralci proteaz.
The entecavir-TP Ki for HBV DNA polymerase is 0.0012 μM.
Ki entekavir trifosfata za HBV DNA polimerazo je 0,0012 μM.
The entire content of the syringe (Removab concentrate plus air buffer) is injected from the pre-filled syringe directly into the sodium chloride 9 mg/ml (0.9%) solution for injection.
Injicirajte celotno vsebino brizge (koncentrat zdravila Removab z zračnim pufrom) iz napolnjene brizge neposredno v raztopino natrijevega klorida 9 mg/ml za injiciranje (0,9 %).
The entire contents of each sachet is to be poured over a small amount of soft food (e.g. apple sauce or vanilla pudding).
Celotno vsebino vrečice je treba stresti na majhno količino mehke hrane (npr. jabolčne čežane ali vanilijevega pudinga).
The entire contents of each sachet should be suspended in 9.4 mL of liquid (water, chocolate milk, or infant formula) giving a final concentration of 10 mg per mL.
Celotno vsebino vsake vrečice je treba suspendirati v 9,4 ml tekočine (vode, čokoladnega mleka ali formule za dojenčke), tako da je končna koncentracija 10mg/ml.
The entire contents of the reconstituted vial (1.2 mL) is then further diluted aseptically with 5.3 mL dextrose 5%w/v solution for injection to a total volume of 6.5 mL providing a final concentration of 200 µg/mL (3.3 x 106 IU/mL) of IL-2 (aldesleukin).
Celotno vsebino rekonstituirane viale (1,2 mL) nadalje aseptično razredčimo s 5,3 mL 5 % m/v raztopine dekstroze za injiciranje do celotnega volumna 6,5 mL, ki zagotavlja končno koncentracijo 200 µg/mL (3,3 x 106 i.e./mL) IL-2 (aldeslevkina).
The entire prescribed Busilvex dose should be delivered over two or three hours depending of the conditioning regimen.
Infuzija celotnega predpisanega odmerka zdravila Busilvex mora trajati dve ali tri ure, odvisno od pripravljalne terapije.
The entire prescribed busulfan dose should be delivered over two or three hours depending of the conditioning regimen.
Infuzija celotnega predpisanega odmerka busulfana mora trajati dve ali tri ure, odvisno od pripravljalne sheme.
The entire treatment area will be illuminated with a red light source, either with a narrow spectrum around 630 nm and a light dose of approximately 37 J/cm2 or a broader and continuous spectrum in the range between 570 and 670 nm with a light dose between 75 and 200 J/cm2.
Celotno območje zdravljenja se osvetli z virom rdeče svetlobe ozkega spektra z valovno dolžino okoli 630 nm in odmerkom svetlobe približno 37 J/cm2 ali širšega in kontinuiranega spektra z valovno dolžino med 570 in 670 nm ter odmerkom svetlobe med 75 in 200 J/cm2.
The entire volume of the bag must be infused.
Infundirati je treba celotno količino vreče.
The entire volume of the bag should be infused into the patient’s vein at a constant rate over a period of 1 hour using a standard infusion pump.
Celotno količino infuzijske vrečke je treba bolniku infundirati intravensko s standardno infuzijsko črpalko in stalno hitrostjo v obdobju ene ure.
The entire volume of the bag should be infused.
Infundirati je treba celotno količino vreče.
The entire volume of the reconstituted and diluted BLINCYTO will be more than the volume to be administered to the patient (240 mL).
Celotna količina rekonstituiranega in razredčenega zdravila BLINCYTO bo večja od količine, ki bo dana bolniku (240 ml).
The entire volume should be infused intravenously into the patient at a constant rate over a period of
Celotno količino je treba bolniku infundirati intravensko s standardno infuzijsko črpalko in stalno hitrostjo v obdobju ene ure.
The entire, fully diluted ORENCIA solution should be administered over a period of 30 minutes and must be administered with an infusion set and a sterile, non-pyrogenic, low-protein-binding filter (pore size of 0.2 to 1.2 μm).
Vso količino popolnoma razredčene raztopine ORENCIA morate aplicirati v obliki 30-minutne infuzije preko infuzijskega sistema in sterilnega apirogenega filtra, ki minimalno veže proteine (velikost por 0,2 do 1,2 μm).
The environmental risk assessment of strontium ranelate has been conducted in accordance to European guidelines on ERA.
Ocena tveganja za okolje stroncijevega ranelata je bila izvedena v skladu z evropskimi smernicami o ERA.