natgillin/translations-raw huggingface dataset:
The apparent oral clearance (CL/F) is approximately
Navidezni peroralni očistek (CL/F) pri bolnikih, okuženih s
The apparent oral clearance of bazedoxifene is approximately 4 to 5 l/h/kg.
Navidezni peroralni očistek bazedoksifena je približno 4 do 5 l/h/kg.
The apparent steady state volume of distribution (Vss/F) of febuxostat ranges from 29 to 75 L after oral doses of 10-300 mg.
Navidezni volumen porazdelitve v stanju dinamičnega ravnovesja (Vss/F) febuksostata je po peroralnih odmerkih 10-300 mg od 29 do 75 l.
The apparent steady-state volume of distribution was estimated to be 73.8 l based on the population pharmacokinetic analysis.
Navidezni volumen porazdelitve v stanju dinamičnega ravnovesja je bil na podlagi populacijske farmakokinetične analize ocenjen na 73,8 l.
The apparent terminal half-life (t1/2) (expressed as mean ± standard deviation) was 10.6 ± 2.13 hours and 13.1 ± 3.28 hours for the 100 mg and 300 mg doses, respectively.
Navidezni končni razpolovni čas (t1/2) (izražen kot povprečna vrednost ± standardna deviacija) je bil 10,6 ± 2,13 ur oziroma 13,1 ± 3,28 ur pri odmerku 100 mg oziroma 300 mg.
The apparent terminal half-life (t1/2) (expressed as mean ± standard deviation) was 10.6 ± 2.13 hours and 13.1 ± 3.28 hours for the 100 mg and 300 mg doses, respectively.
Navidezni končni razpolovni čas (t1/2) (izražen kot povprečna vrednost ± standardna deviacija) je bil 10,6 ± 2,13 ure oziroma 13,1 ± 3,28 ure pri odmerku 100 mg oziroma 300 mg.
The apparent total body clearance at steady state (CL/F) increased with age over the 3-month period with a corresponding decrease in AUC.
Opažen skupni telesni očistek pri stanju dinamičnega ravnovesja (CL/F) se je v tem trimesečnem obdobju s starostjo večal, vrednost AUC pa se je ustrezno manjšala.
The apparent volume of distribution (V/F) was estimated at 8.01 l in a population pharmacokinetic analysis of patients with rheumatoid arthritis.
V populacijski farmakokinetični analizi bolnikov z revmatoidnim artritisom je bil navidezni volumen porazdelitve (V/F) ocenjen na 8.01 l.
The apparent volume of distribution (VB/F) of ritonavir is approximately 20 - 40 l after a single 600 mg dose.
Navidezni volumen porazdelitve (VB/F) ritonavirja je po enem samem 600 mg odmerku približno 20-40 l.
The apparent volume of distribution (Vd) for sunitinib was large, 2230 l, indicating distribution into the tissues.
Navidezni volumen porazdelitve (Vd) za sunitinib je bil velik – 2.230 l – kar kaže, da se sunitinib porazdeli v tkiva.
The apparent volume of distribution (Vd) is 2.2 l/kg and the elimination half-life t1⁄2) is one hour.
Navidezni volumen porazdelitve (Vd) je 2,2 l/kg, razpolovni čas izločanja (t1⁄2) pa ena ura.
The apparent volume of distribution after intravenous administration of emtricitabine was 1.4±0.3 l/kg, indicating that emtricitabine is widely distributed throughout the body to both intracellular and extracellular fluid spaces.
Po intravenozni uporabi emtricitabina je bil opažen volumen porazdelitve 1,4 ± 0,3 l/kg, kar nakazuje, da je emtricitabin v telesu široko distribuiran tako znotraj kot zunaj celičnega prostora.
The apparent volume of distribution after subcutaneous administration is 11­17 l.
Navidezni volumen porazdelitve po subkutani aplikaciji je 11-17 l.
The apparent volume of distribution after subcutaneous administration of lixisenatide (Vz/F) is approximately 100 L.
Navidezni volumen porazdelitve po subkutani uporabi liksisenatida (Vz/F) je približno 100 l.
The apparent volume of distribution at steady state is 46±21 l.
Navidezni volumen porazdelitve v stanju dinamičnega ravnovesja je 46 ± 21 l.
The apparent volume of distribution for telmisartan is approximately 500 litres indicating additional tissue binding.
Povprečen navidezen volumen porazdelitve je približno 500°l, kar kaže na dodatno tkivno vezavo.
The apparent volume of distribution is 17 L to 20 L in HIV-infected patients, based on a population pharmacokinetic analysis.
Navidezni volumen porazdelitve pri bolnikih, okuženih s HIV, je na podlagi populacijske farmakokinetične analize od 17 do 20 l.
The apparent volume of distribution is 487 l.
Njegov navidezni porazdelitveni volumen je 487 l.
The apparent volume of distribution is about
Navidezni volumen porazdelitve pri odraslih je med
The apparent volume of distribution is about 1.1 – 1.7 l/kg in adults indicating that zonisamide is extensively distributed to tissues.
Volumen porazdelitve pri odraslih je med 1,1 - 1,7 l/kg, kar kaže na to, da se zonisamid močno porazdeljuje v tkiva.
The apparent volume of distribution of miglustat is 83 l.
Navidezni volumen porazdelitve miglustata je 83 l.
The apparent volume of distribution of pegvisomant is relatively small (7-12 L).
Navidezni volumen porazdelitve pegvisomanta je razmeroma majhen (7–12 l).
The apparent volume of distribution was 806 L in cancer patients based on population pharmacokinetic analysis.
Na podlagi populacijske farmakokinetične analize je bil navidezni volumen porazdelitve pri onkoloških bolnikih 806 l.
The appearance of insulin should also be checked: the insulin solution must be clear, colourless, with no solid particles visible, and must have a water-like consistency.
Prav tako je treba preveriti izgled insulina: raztopina insulina mora biti čista, brezbarvna, brez vidnih delcev in vodi podobne konsistence.
The appearance of insulin should also be checked: the insulin solution must be clear, colourless, with no solid particles visible, and must have a water-like consistency.
Preveriti morate tudi videz insulina: raztopina insulina mora biti bistra, brezbarvna, vodi podobno konsistence in ne sme vsebovati trdnih delcev.
The appearance of the insulin should be checked: the insulin suspension must have an evenly milky-white appearance.
Prav tako je treba preveriti izgled insulina: suspenzija insulina mora biti enakomerno mlečno bela.
The Applicant has committed to provide data from an on-going COG study AALL0434.
Predlagatelj se je zavezal posredovati podatke iz COG študije AALL0434, ki je v teku.
The Applicant is asked to commit to take appropriate measures to harmonise the productions and/or to provide the adequate demonstrations/data to solve the issues.
Predlagatelja prosimo, da sprejme ustrezne ukrepe za usklajevanje izdelovanja in/ali da priskrbi primerne predstavitve/podatke za rešitev teh vprašanj.
The applicant is requested to submit periodic analysis of the CF study every 6 months for 3 years and annually for 2 years.
Predlagatelj mora predložiti redne analize študije CF vsakih 6 mesecev v obdobju 3
The Applicant should agree to specify the NZ-Amine(s) used in production and only to source Tryptose and these specified NZ-Amine(s) from specified companies from whom suitable ‘milk statements’ have been submitted in the dossier, together with details of the countries of origin of the source animals.
Predlagatelj mora soglašati, da bo podrobno navedel NZ-amin(e), ki jih bo uporabil v proizvodnji in kot vir za triptozo in podrobno naveden(e) NZ- amin(e) uporabljal samo podjetja, za katera so v dokumentaciji primerne 'izjave o mleku' in podrobni podatki o državah izvora živali, ki služijo kot vir.
The applicant should conduct a 5-year long-term observational study with lumacaftor/ivacaftor in patients with cystic fibrosis, including also microbiological and clinical endpoints (e.g. exacerbations) according to an approved protocol.
Predlagatelj mora izvesti 5-letno dolgoročno opazovalno študijo z lumakaftorjem/ivakaftorjem pri bolnikih s cistično fibrozo, ki bo vključevala tudi mikrobiološke in klinične opazovane dogodke (npr. eksacerbacije), v skladu z odobrenim protokolom.
The applicant should submit the final study report for Phase 3 extension study GS-US-312-0117, to evaluate the efficacy and safety of idelalisib (GS-1101) in combination with rituximab for previously treated CLL.
Predlagatelj mora predložiti končno poročilo o študiji za podaljšano študijo 3. faze GS-US-312-0117 za ocenitev učinkovitosti in varnosti idelaliziba (GS-1101) v kombinaciji z rituksimabom za predhodno zdravljeno KLL.
The applicant should submit the final study report for the extension study 101-99.
Predlagatelj mora predložiti končno poročilo o študiji za podaljšano študijo 101-99.
The applicant will implement collection of material for biomarker
Vlagatelj bo vključil zbiranje materialov za preiskave biomarkerjev in analize
The Applicant/MAH commits to establish the
Predlagatelj/imetnik dovoljenja za promet se zavezuje, da
The Applicant/MAH commits to provide abridged report for the following study performed in adults:
Predlagatelj/imetnik dovoljenja za promet se zavezuje, da bo predložil skrajšano poročilo o naslednji študiji, izvedeni pri odraslih: študija Q-Pan H1N1-001 skrajšano poročilo za po 1. in po
The Applicant/MAH commits to support a Post- authorisation study in immunocompromised subjects (adults with HIV) being conducted by PCIRN (Public Health Agency of Canada - Canadian Institutes of Health Research Influenza Research Network) and provide the final result
Predlagatelj/imetnik dovoljenja za promet se zavezuje, da bo podprl postavtorizacijsko študijo pri imunsko oslabelih osebah (odrasli s HIV), ki jo izvaja PCIRN (Public Health Agency of Canada – Canadian Institutes of Health Research Influenza Research Network), in da bo posredoval končne rezultate.
The Applicant/MAH commits to support an effectiveness study with Arepanrix ongoing and submit the results one week after being available.
Predlagatelj/imetnik dovoljenja za promet se zavezuje, da bo podprl študijo učinkovitosti cepiva Arepanrix, ki že poteka, in bo predložil rezultate en teden potem, ko bodo na voljo.
The Applicant/MAH shall agree with Member Sates on the provision of a targeted communication to healthcare professionals which should address the following:
Predlagatelj/Imetnik dovoljenja za promet se bo z državami članicami dogovoril o zagotavljanju ciljanega obveščanja za zdravnike, ki mora obravnavati naslednje:
The Applicant/MAH shall agree with Member States on mechanisms allowing patients and health care professionals to have continuous access to updated information regarding Arepanrix.
Predlagatelj/Imetnik dovoljenja za promet se bo z državami članicami dogovoril o mehanizmih, ki bodo bolnikom in zdravnikom omogočali stalen dostop do posodobljenih informacij o cepivu Arepanrix.
The Applicant/MAH shall agree with Member States to measures facilitating the identification and traceability of the A/H1N1 pandemic vaccine administered to each patient, in order to minimise medication errors and aid patients and health care professionals to report adverse reactions.
Predlagatelj/Imetnik dovoljenja za promet se bo z državami članicami dogovoril o ukrepih za lažjo identifikacijo in sledljivost pandemskega cepiva A/H1N1, uporabljenega pri posameznem bolniku, da bi čim bolj zmanjšali napake pri uporabi cepiva ter v pomoč bolnikom in zdravnikom pri poročanju o neželenih učinkih.
The Applicant/MAH will support one prospective and one retrospective cohort safety study with Arepanrix, in at least 9,000 patients, in accordance with the protocols submitted with the Risk Management Plan.
Predlagatelj/imetnik dovoljenja za promet bo podprl eno prospektivno in eno retrospektivno kohortno študijo varnosti cepiva Arepanrix pri vsaj 9.000 pacientih, v skladu s protokoli, vloženimi z načrtom za obvladovanje tveganja.
The application area is first wiped with an ethanol or isopropanol-soaked cotton pad to degrease the skin.
Predel nanosa je treba obrisati z bombažno blazinico, navlaženo z etanolom ali izopropanolom, za razmastitev kože.
The application of Activyl Tick Plus may produce a temporary oily appearance or hair clumping at the application site, or a dry white residue.
Uporaba zdravila Activyl Tick Plus lahko povzroči kratkotrajen oljni videz ali zlepljanje dlake na mestu nanosa ali suh, bel ostanek.
The application of the veterinary medicinal product may produce a local, temporary oily appearance and clumping or spiking of the hair at the application site.
Nanos zdravila lahko lokalno povzroči začasen masten izgled in vozlanje in zlepljanje dlake na mestu nanosa.
The application site preparation and duration of incubation followed the description under section 4.2. If not completely cleared 12 weeks after initial treatment, lesions or cancerized fields were treated a second time with an identical regimen.
Priprava mesta nanosa in trajanje inkubacijske dobe sta opisana v poglavju 4.2. Če 12 tednov po prvem zdravljenju lezije ali polja kancerizacije niso popolnoma izginili, so jih na enak način zdravili še enkrat.
The approaches recommended for mitigation of risk of venous thromboembolism based on the SmPC, including contraindication of FABLYN in patients with active or past history of VTE.
Priporočeni pristopi zmanjšanja tveganja za pojava venskih trombemboličnih dogodkov temeljijo na SmPC, vključno s kontraindikacijo zdravila FABLYN pri bolnicah z aktivno vensko trombembolično boleznijo ali boleznijo v anamnezi.
The appropriate amount of solution should be withdrawn from the vial and added to an infusion bag containing 250 mL of 0.9 % sodium chloride solution.
Primerno količino raztopine je treba odvzeti iz viale in dodati infuzijski vrečki, ki vsebuje 250 ml 0,9 % raztopine natrijevega klorida.
The appropriate amount of solution should be withdrawn from the vial and added to an infusion bag containing 250 mL of sodium chloride 4.5 mg/ml (0.45%) solution for infusion or sodium chloride
Ustrezno količino raztopine je treba odvzeti iz viale in dodati infuzijski vrečki, ki vsebuje 250 ml 0,45
the appropriate combination of pipettes
ustrezna velikost merilne kapalke
the appropriate combination of pipettes
ustrezno število merilnih kapalk
The appropriate dose depends on the symptoms of the disease, amount of fat in the stool, fat content of the diet and the patient’s weight.
Ustrezni odmerek je odvisen od simptomov bolezni, količine maščobe v blatu, deleža maščob v prehrani in bolnikove telesne mase.
The appropriate dose is determined by the dog’s body weight.
Ustrezen odmerek se določi glede na telesno maso psa.
The appropriate dose must be mixed by the caregiver with an equal quantity of sweet liquid food, such as sugar water, chocolate syrup, cherry syrup, dessert toppings (like caramel or fudge sauce) to mask the bitter taste.
Skrbnik mora zmešati ustrezen odmerek z enako količino sladke tekoče hrane, kot je sladkana voda, čokoladni sirup, češnjev sirup, prelivi za sladice (kot je karamelni ali čokoladni preliv), da se zakrije grenak okus.
The appropriate doses for
Ustreznih odmerkov za to
The appropriate doses for this combination, with respect to efficacy and safety, have not been established.
očasni uporabi indinavirja/ritonavirja in
The appropriate number of tablets, half tablets or quarter tablets to give according to the dog’s size is given in the Package Leaflet.
Ustrezno število tablet, polovičk tablet ali četrtink tablet, ki jih morate psu dati glede njegovo velikost, je podano v Navodilu za uporabo.
The appropriate number of vials should be opened under the water or the content of the cup(s) should be poured into the water.
Ustrezno število vial odpremo pod vodo ali vsebino meric(e) stresti v vodo.
The appropriate number of vials should be opened under water or the content of the cup(s) should be poured into the water.
Ustrezno število vial odpremo pod vodo ali pa vsebino meric(e) stresemo v vodo.
The appropriate quantity of Profender (either the contents of one full pipette or the volume measured by the vet) is applied onto the cat’s skin, after parting the fur on the back of its neck at the base of its head.
Ustrezno količino zdravila Profender (vsebino ene polne kapalke ali količino, ki jo odmeri veterinar) je treba nanesti mački na zatilje in sicer je treba razmakniti dlako, da je vidna koža.
The appropriate strength for administration to individuals from birth through 15 years of age is HBVAXPRO 5 micrograms.
Primerna jakost za cepljenje posameznikov od rojstva do 15. leta starosti je cepivo HBVAXPRO 5 mikrogramov.
The appropriate strength for administration to individuals from birth through 15 years of age is HBVAXPRO 5 micrograms.
Primerna jakost za cepljenje posameznikov od rojstva do 15. leta starosti je HBVAXPRO 5 mikrogramov.
The appropriate strength tablet should be used according to the dog’s weight.
Ustrezna jakost tablete se določi glede na telesno maso psa.
The appropriate strength tablet(s) should be used according to the dog’s or cat’s weight (the dose differs between dogs and cats).
Uporabiti je treba ustrezno jakost tablet glede na maso psa ali mačke (odmerek se razlikuje glede na to, ali se daje psom ali mačkam).
The appropriate strength tablet(s) should be used according to the dog’s weight.
Ustrezna jakost tablete oz. tablet se določi glede na telesno maso psa.
The appropriate use of Ebilfumin for prevention of influenza should be determined on a case by case basis by the circumstances and the population requiring protection.
Primernost uporabe zdravila Ebilfumin za preprečevanje gripe moramo določiti za vsak posamezen primer posebej, odvisno od okoliščin in skupine ljudi, ki potrebuje zaščito.
The appropriate use of Tamiflu for prevention of influenza should be determined on a case by case basis by the circumstances and the population requiring protection.
Primernost uporabe zdravila Tamiflu za preprečevanje gripe moramo določiti za vsak posamezen primer posebej, odvisno od okoliščin in skupine ljudi, ki potrebuje zaščito.
The appropriate volume of pemetrexed concentrate must be diluted to 100 ml with 5% glucose solution and administered as an intravenous infusion over 10 minutes.
Ustrezen volumen koncentrata pemetrekseda je potrebno razredčiti do 100 ml s 5% raztopino glukoze in uporabiti kot intravensko infuzijo, ki traja 10 minut.
The appropriate volume of reconstituted pemetrexed solution must be further diluted to 100 ml with 5% glucose intravenous infusion and administered as an intravenous infusion over 10 minutes.
Ustrezno prostornino rekonstituirane raztopine pemetrekseda se mora še nadalje redčiti do 100 ml s 50 mg/ml (5,0 %) raztopino glukoze za intravensko infundiranje, daje se kot intravenska infuzija, ki teče 10 minut.
The appropriate volume of reconstituted pemetrexed solution must be further diluted to 100 ml with sodium chloride 9 mg/ml (0.9%) solution for injection (without preservative) or with glucose 50 mg/ml (5%) solution for injection (without preservative) and administered as an intravenous infusion over 10 minutes.
Ustrezno prostornino rekonstituirane raztopine pemetrekseda moramo še nadalje redčiti do 100 ml z 9 mg/ml (0,9 %) raztopino natrijevega klorida za injiciranje (brez konzervansa) ali z raztopino za injiciranje (brez konzervansa)glukozo 50 mg/ml (5%) damo jo kot intravensko infuzijo, ki teče 10 minut.
The appropriate volume of reconstituted pemetrexed solution must be further diluted to 100 ml with sodium chloride 9 mg/ml (0.9%) solution for injection (without preservative) or with glucose 50 mg/ml (5%) solution for injection (without preservative) and administered as an intravenous infusion over 10 minutes.
Ustrezno prostornino rekonstituirane raztopine pemetrekseda moramo še nadalje redčiti do 100 ml z 9 mg/ml (0,9 %) raztopino natrijevega klorida za injiciranje brez konzervansa, damo jo kot intravensko infuzijo, ki teče 10 minut.
The approved shelf life of EVICEL is 24 months storage at ≤ -18oC.
Odobreni rok uporabnost zdravila EVICEL je 24 mesecev ob shranjevanju pri ≤ –18 oC.
The approved shelf life of EVICEL is 24 months storage at ≤ -18oC.
Odobreni rok uporabnosti izdelka EVICEL je 24 mesecev ob shranjevanju pri ≤ –18 oC.
The approximate amount of perflutren gas in each ml of OPTISON is 0.19 mg
V enem ml kontrastnega sredstva OPTISON je približno 0,19 mg perflutren plina.
The approximate amount of perflutren gas in each ml of OPTISON is 0.19 mg.
Približna količina perflutren plina v vsakem ml zdravila OPTISON je 0,19 mg.
The approximate percentage of IgG subclasses is as follows: IgG1 .....................
Približni odstotek podrazredov IgG je naslednji: IgG1....................................
The aprepitant regimen for adolescents aged 12 through 17 years (n=47) consisted of EMEND capsules 125 mg orally on Day 1 and 80 mg/day on Days 2 and 3 in combination with ondansetron on Day 1.
Shema z aprepitantom je za mladostnike, stare od 12 do 17 let (n = 47), obsegala 125 mg kapsulo zdravila EMEND peroralno 1. dan in 80 mg/dan 2. in 3. dan v kombinaciji z ondansetronom 1. dan.
The Aranesp pre-filled pen should NEVER be reused.
Napolnjenega injekcijskega peresnika Aranesp ne smete NIKOLI ponovno uporabiti.
The area from which you wish to remove the eschar must be surrounded with a sterile paraffin ointment adhesive barrier by applying it a few centimetres outside of the treatment area (using a dispenser).
Površino, s katere želite odstraniti eshare, morate obdati z adhezivno pregrado iz sterilnega parafinskega mazila, ki ga nanesete nekaj centimetrov zunaj zdravljenega predela (uporabite razdeljevalec).
The area from which you wish to remove the eschar must be surrounded with a sterile paraffin ointment adhesive barrier by applying it a few centimetres outside of the treatment area (using a dispenser).
Površino, s katere želite odstraniti esharje, morate obdati z adhezivno pregrado iz sterilnega parafinskega mazila, ki ga nanesete nekaj centimetrov zunaj zdravljenega predela (uporabite razdeljevalec).
The area under the concentration-time curve (AUC) to minimum inhibitory concentration (MIC) ratio of oritavancin for the infecting organism has been shown to be the parameter that best correlates with efficacy.
Pokazalo se je, da je parameter, ki najboljše korelira z učinkovitostjo, razmerje med površino pod krivuljo koncentracija-čas (AUC, area under the concentration-time curve) in minimalno inhibitorno koncentracijo (MIC, minimum inhibitory concentration) oritavancina za povzročitelje okužbe.
The area under the plasma concentration-time curve increases with repeated administration of esomeprazole.
Površina pod krivuljo plazemske koncentracije po času se med uporabo večkratnih odmerkov esomeprazola povečuje.
The area where the radioactive compound is collected, will light up on the picture and give information on the location of the tumour.
Predel v katerem se zbere radioaktivna spojina bo na sliki osvetljen in bo dal informacijo o mestu tumorja.
The aripiprazole Long-Acting Injectable 50 mg/25 mg dose was included as a low dose aripiprazole to test assay sensitivity for the non-inferiority design.
Odmerki dolgodelujočega parantertalnega aripiprazola 50 mg/25 mg so bili vključeni kot nizki odmerki aripiprazola, da bi preizkusili občutljivost analize pri dokazovanju neinferiornosti zdravila.
The ARs listed in the tables below fall into the following categories: Very common ( 1/10), common ( 1/100 to < 1/10), uncommon ( 1/1,000 to < 1/100), rare ( 1/10,000 to < 1/1,000), and very rare (< 1/10,000).
Neželeni učinki, ki so našteti v spodnjih preglednicah, so razvrščeni v poglavja glede na pogostnost: zelo pogosti ( 1/10), pogosti ( 1/100 do < 1/10), občasni ( 1/1000 do < 1/100), redki ( 1/10.000 do < 1/1000) in zelo redki (< 1/10.000).
The ARs reported in these three clinical studies are summarised and categorised according to the MedDRA System Organ Class and frequency below.
Neželeni učinki, o katerih so poročali v teh treh študijah, so povzeti in razvrščeni glede na organske sisteme po MedDRA in pogostnosti.
The ART is defined as the end of production. (GBq: GigaBecquerel is the unit in which radioactivity is measured).
Referenčni čas aktivnosti je določen kot konec izdelave. (GBq: gigabekerel je enota za merjenje radioaktivnosti).
The Arzerra concentrate must be diluted in sodium chloride 9 mg/ml (0.9%) solution for injection prior to administration, using aseptic technique.
Koncentrat zdravila Arzerra je treba pred uporabo razredčiti v 9 mg/ml (0,9 %) raztopini natrijevega klorida za injiciranje upoštevaje aseptičen postopek.