FrancophonIA/ELRC3.0 huggingface dataset:
English: A Phase 4 study (DAP-PEDBAC-11-02) was conducted to assess safety, efficacy, and pharmacokinetics of daptomycin in paediatric patients (1 to 17 years old, inclusive) with SAB. Daptomycin pharmacokinetics inpatients in this study are summarized in Table 3.
Slovenian: Pediatrični bolniki z bakteriemijo z bakterijo Staphylococcus aureus Za oceno varnosti, učinkovitosti in farmakokinetike daptomicina pri pediatričnih bolnikih (od 1 do vključno 17 let starosti) z bakteriemijo z bakterijo Staphylococcus aureus so izvedli študijo 4. faze (DAP-PEDBAC-11-02).
English: Indication cSSTI without SAB
Slovenian: Indikacija Zapletene okužbe kože in mehkih tkiv (cSSTI) brez SAB
English: A 50 mg/ml concentration of Cubicin 350 mg powder for injection is obtained by reconstituting the lyophilised product with 7 ml of sodium chloride 9 mg/ml (0.9%) solution for injection.
Slovenian: Koncentracijo 50 mg/ml zdravila Cubicin 350 mg prašek za injiciranje je mogoče pripraviti z rekonstitucijo liofiliziranega zdravila s 7 ml raztopine natrijevega klorida 9 mg/ml (0,9 %) za injekcije.
English: In the paediatric SAB study, the mean duration of IV Cubicin was 12 days, with a range of 1 to 44 days.
Slovenian: V pediatrični SAB študiji je bilo srednje trajanje zdravljenja z zdravilom Cubicin i.v.
English: Cubicin 350 mg powder for solution for injection or infusion To prepare Cubicin for intravenous injection, please adhere to the following instructions: Aseptic technique should be used throughout to reconstitute lyophilised Cubicin.
Slovenian: Cubicin 350 mg prašek za raztopino za injiciranje ali infundiranje Pri pripravljanju zdravila Cubicin za intravensko injiciranje upoštevajte naslednja navodila: Za rekonstitucijo liofiliziranega zdravila Cubicin je treba med celotnim postopkom uporabljati aseptično tehniko.
English: One ml provides 50 mg of daptomycin after reconstitution with 7 ml of sodium chloride 9 mg/ml (0.9%) solution.
Slovenian: En ml po rekonstituciji s 7 ml raztopine natrijevega klorida 9 mg/ml (0,9 %) vsebuje 50 mg daptomicina.
English: Cubicin 500 mg powder for solution for injection or infusion To prepare Cubicin for intravenous injection, please adhere to the following instructions: Aseptic technique should be used throughout to reconstitute lyophilised Cubicin.
Slovenian: Cubicin 500 mg prašek za raztopino za injiciranje ali infundiranje Pri pripravljanju zdravila Cubicin za intravensko injiciranje upoštevajte naslednja navodila: Za rekonstitucijo liofiliziranega zdravila Cubicin je treba med celotnim postopkom uporabljati aseptično tehniko.
English: Reproductive system and breast disorders
Slovenian: Motnje reprodukcije in dojk občasni:
English: Cubicin 350 mg powder for solution for injection or infusion To prepare Cubicin for intravenous infusion, please adhere to the following instructions: Aseptic technique should be used throughout to reconstitute or dilute lyophilised Cubicin.
Slovenian: Cubicin 350 mg prašek za raztopino za injiciranje ali infundiranje Pri pripravljanju zdravila Cubicin za intravensko infundiranje upoštevajte naslednja navodila: Za rekonstitucijo ali redčenje liofiliziranega zdravila Cubicin je treba med celotnim postopkom uporabljati aseptično tehniko.
English: One ml provides 50 mg of daptomycin after reconstitution with 10 ml of sodium chloride 9 mg/ml (0.9%) solution.
Slovenian: En ml po rekonstituciji z 10 ml raztopine natrijevega klorida 9 mg/ml (0,9 %) vsebuje 50 mg daptomicina.
English: A 50 mg/ml concentration of Cubicin 500 mg powder for injection is obtained by reconstituting the lyophilised product with 10 ml of sodium chloride 9 mg/ml (0.9%) solution for injection.
Slovenian: Koncentracijo 50 mg/ml zdravila Cubicin 500 mg prašek za injiciranje dobimo z rekonstitucijo liofiliziranega zdravila z 10 ml raztopine natrijevega klorida 9 mg/ml (0,9 %) za injiciranje.
English: Cubicin 500 mg powder for solution for injection or infusion To prepare Cubicin for intravenous infusion, please adhere to the following instructions: Aseptic technique should be used throughout to reconstitute or dilute lyophilised Cubicin.
Slovenian: Cubicin 500 mg prašek za raztopino za injiciranje ali infundiranje Pri pripravljanju zdravila Cubicin za intravensko infundiranje upoštevajte naslednja navodila: Za rekonstitucijo ali redčenje liofiliziranega zdravila Cubicin je treba med celotnim postopkom uporabljati aseptično tehniko.
English: 6.1 List of excipients
Slovenian: 6.1 Seznam pomožnih snovi natrijev hidroksid
English: A 50 mg/ml concentration of Cubicin 500 mg powder for infusion is obtained by reconstituting the lyophilised product with 10 ml of sodium chloride 9 mg/ml (0.9%) solution for injection.
Slovenian: Koncentracijo 50 mg/ml zdravila Cubicin 500 mg prašek za infundiranje dobimo z rekonstitucijo liofiliziranega zdravila z 10 ml raztopine natrijevega klorida 9 mg/ml (0,9 %) za injiciranje.
English: A 50 mg/ml concentration of Cubicin for infusion can be achieved by reconstituting the lyophilised product with 7 ml of sodium chloride 9 mg/ml (0.9%) solution for injection.
Slovenian: Koncentracijo 50 mg/ml zdravila Cubicin za vnos z infuzijo je mogoče pripraviti z rekonstitucijo liofiliziranega zdravila s 7 ml raztopine natrijevega klorida 9 mg/ml (0,9 %) za injiciranje.
English: A 50 mg/ml concentration of Cubicin for infusion can be achieved by reconstituting the lyophilised product with 10 ml of sodium chloride 9 mg/ml (0.9%) solution for injection.
Slovenian: Koncentracijo 50 mg/ml zdravila Cubicin za vnos z infuzijo je mogoče pripraviti z rekonstitucijo liofiliziranega zdravila s 10 ml raztopine natrijevega klorida 9 mg/ml (0,9 %) za injiciranje.
English: A 50 mg/ml concentration of Cubicin for injection is obtained by reconstituting the lyophilised product with 7 ml of sodium chloride 9 mg/ml (0.9%) solution for injection.
Slovenian: Koncentracijo 50 mg/ml zdravila Cubicin za injiciranje je mogoče pripraviti z rekonstitucijo liofiliziranega zdravila s 7 ml raztopine natrijevega klorida 9 mg/ml (0,9 %) za injekcije.
English: A 50 mg/ml concentration of Cubicin for injection is obtained by reconstituting the lyophilised product with 10 ml of sodium chloride 9 mg/ml (0.9%) solution for injection.
Slovenian: Koncentracijo 50 mg/ml zdravila Cubicin za injiciranje je mogoče pripraviti z rekonstitucijo liofiliziranega zdravila s 10 ml raztopine natrijevega klorida 9 mg/ml (0,9 %) za injekcije.
English: Keeping the vial inverted, position the needle tip at the very bottom of the solution in the vial when drawing the solution into the syringe.
Slovenian: Ko raztopino vlečete v injekcijsko brizgo, naj bo konica injekcijske igle v še vedno obrnjeni viali nameščena čisto na dnu raztopine v viali.
English: Aniseed medicines should only be used in adults and adolescents over the age of 12 years and should not be taken for longer than two weeks.
Slovenian: Zdravila, ki vsebujejo plod vrtnega janeža, se smejo uporabljati samo pri odraslih in mladostnikih, starejših od 12 let, in se ne smejo uporabljati več kot dva tedna.
English: Aniseed EMA/305345/2016
Slovenian: september 2016 EMA/305345/2016
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom20 September 2016 EMA/305345/2016
Slovenian: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom20.
English: This summary is not intended to provide practical advice on how to use medicines containing aniseed.
Slovenian: Povzetek ni namenjen zagotavljanju praktičnih nasvetov o uporabi zdravil, ki vsebujejo plod vrtnega janeža.
English: Aniseed is the common name for the fruit of the plant Pimpinella anisum L.
Slovenian: Plod vrtnega janeža je splošno ime za plod rastline Pimpinella anisum L.
English: If symptoms last or get worse during the use of the medicine, a doctor or a qualified health care practitioner should be consulted.
Slovenian: Če simptomi med uporabo zdravila ne popustijo ali se poslabšajo, se je treba posvetovati z zdravnikom ali usposobljenim zdravstvenim
English: Aniseed medicines must not be used in patients who are allergic to aniseed or to plants of the Apiaceae family (Umbelliferae) (caraway, celery, coriander, dill, fennel) or anethole.
Slovenian: Zdravila, ki vsebujejo plod vrtnega janeža, se ne smejo uporabljati pri bolnikih, ki so alergični na plod vrtnega janeža ali rastline iz družine Apiaceae (Umbelliferae) (kumino, zeleno, koriander, koper, komarček) ali anetol.
English: Further information on the risks associated with these aniseed medicines, including the appropriate precautions for their safe use, can be found in the monograph under the tab ‘All documents' on the Agency's website: ema.europa.eu/Find medicine/Herbal medicines for human use.
Slovenian: Dodatne informacije o tveganjih, povezanih s temi zdravili, ki vsebujejo plod vrtnega janeža, vključno z ustreznimi previdnostnimi ukrepi za njihovo varno uporabo, so na voljo v monografiji na spletni strani agencije pod zavihkom „Vsi dokumenti“: ema.europa.eu/Find medicine/Herbal medicines for human use.
English: This is a summary of the scientific conclusions reached by the Committee on Herbal Medicinal Products (HMPC) on the medicinal uses of aniseed.
Slovenian: To je povzetek znanstvenih zaključkov Odbora za zdravila rastlinskega izvora (HMPC) v zvezi z medicinsko uporabo plodu vrtnega janeža.
English: The HMPC conclusions only cover the dried herbal substance (dried aniseed) and aniseed preparations which are obtained by drying and comminuting (reducing into tiny pieces) or crushing the fruit.
Slovenian: Zaključki odbora HMPC zajemajo samo posušeno rastlinsko snov (posušeni plod vrtnega janeža) in pripravke s plodom vrtnega janeža, ki se pridobivajo s sušenjem in drobljenjem (zmanjševanjem na majhne delce) ali trenjem plodu.
English: In addition, they can be used as an expectorant (a medicine that helps bring up phlegm) for coughs associated with colds.
Slovenian: Poleg tega se lahko uporabljajo tudi kot ekspektoransi (zdravila za lažje izkašljevanje sluzi) pri kašlju, povezanem s prehladom.
English: In its assessment, the HMPC considered laboratory studies which showed aniseed preparations to have a relaxant effect on muscles of the gut and airways.
Slovenian: V svoji oceni je odbor HMPC upošteval laboratorijske študije, ki so pokazale, da imajo pripravki s plodom vrtnega janeža relaksacijski učinek na mišice črevesja in dihalnih poti.
English: The HMPC conclusions on the use of these aniseed medicines for indigestion complaints and coughs are based on their ‘traditional use'.
Slovenian: Zaključki odbora HMPC o uporabi zdravil, ki vsebujejo plod vrtnega janeža, za zdravljenje prebavnih težav in kašlja temeljijo na njihovi „tradicionalni uporabi“.
English: Allergic reactions to aniseed that affect the skin or airways may occur.
Slovenian: Lahko se pojavijo alergijske reakcije na plod vrtnega janeža, ki prizadenejo kožo ali dihalne poti.
English: The HMPC conclusions are taken into account by EU Member States when evaluating applications for the licensing of herbal medicines containing aniseed.
Slovenian: Ugotovitve odbora HMPC države članice EU upoštevajo pri ocenjevanju vlog za izdajo dovoljenja za promet z zdravili rastlinskega izvora, ki vsebujejo plod vrtnega janeža.
English: These aniseed medicines are usually available as herbal tea to be drunk.
Slovenian: Zdravila, ki vsebujejo plod vrtnega janeža, so navadno na voljo kot zdravilni čaj, ki se popije.
English: Further information on the HMPC assessment of aniseed medicines, including details of the Committee's conclusions, can be found under the tab ‘All documents' on the Agency's website: ema.europa.eu/Find medicine/Herbal medicines for human use.
Slovenian: Dodatne informacije o oceni zdravil, ki vsebujejo plod vrtnega janeža, ki jo je opravil odbor HMPC, vključno z njegovimi znanstvenimi zaključki, so na voljo na spletni strani agencije pod zavihkom „Vsi dokumenti“: ema.europa.eu/Find medicine/Herbal medicines for human use.
English: Any applications for the licensing of medicines containing aniseed have to be submitted to the national authorities responsible for medicinal products, which will assess the application for the herbal medicine and take into account the scientific conclusions of the HMPC.
Slovenian: Vlogo za izdajo dovoljenja za promet z zdravili, ki vsebujejo plod vrtnega janeža, je treba predložiti pristojnemu nacionalnemu organu za zdravila, ki bo to vlogo za izdajo dovoljenja za promet z zdravilom rastlinskega izvora ocenil in upošteval znanstvene zaključke odbora HMPC.
English: How are aniseed medicines approved in the EU?
Slovenian: Kako so zdravila, ki vsebujejo plod vrtnega janeža, odobrena v EU?
English: The HMPC concluded that, on the basis of its long-standing use, these aniseed medicines can be used for treating symptoms of mild indigestion complaints including bloating and flatulence.
Slovenian: Odbor HMPC je na podlagi dolgotrajne uporabe zaključil, da se lahko ta zdravila, ki vsebujejo plod vrtnega janeža, uporabljajo za zdravljenje simptomov blagih prebavnih težav, vključno z napihnjenostjo in napenjanjem.
English: Information on the use and licensing of aniseed medicines in EU Member States should be obtained from the relevant national authorities.
Slovenian: Za informacije o uporabi in registraciji zdravil, ki vsebujejo plod vrtnega janeža, v državah članicah EU se obrnite na pristojni nacionalni organ.
English: These aniseed medicines may also be found in combination with other herbal substances in some herbal medicines.
Slovenian: Zdravila, ki vsebujejo plod vrtnega janeža, so v nekaterih zdravilih rastlinskega izvora lahko na voljo tudi v kombinaciji z drugimi rastlinskimi snovmi.
English: Detailed instructions on how to take aniseed medicines and who can use them can be found in the package leaflet that comes with the medicine.
Slovenian: Podrobna navodila o jemanju zdravil, ki vsebujejo plod vrtnega janeža, in o tem, kdo sme ta zdravila jemati, so na voljo v navodilu za uporabo, ki je priloženo posameznemu zdravilu.
English: What evidence supports the use of aniseed medicines?
Slovenian: Kateri dokazi podpirajo uporabo zdravil, ki vsebujejo plod vrtnega janeža?
English: What are the risks associated with aniseed medicines?
Slovenian: Kakšna tveganja so povezana z zdravili, ki vsebujejo plod vrtnega janeža?
English: For more information about treatment with aniseed medicines, read the package leaflet that comes with the medicine or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravili, ki vsebujejo plod vrtnega janeža, preberite navodilo za uporabo, ki je priloženo posameznemu zdravilu, ali se posvetujte z zdravnikom ali farmacevtom.
English: For practical information about using aniseed medicines, patients should read the package leaflet that comes with the medicine or contact their doctor or pharmacist.
Slovenian: Za praktične informacije o njihovi uporabi naj bolniki preberejo navodilo za uporabo, ki je priloženo posameznemu zdravilu, ali se posvetujejo z zdravnikom ali farmacevtom.
English: Other information about aniseed medicines
Slovenian: Druge informacije o zdravilih, ki vsebujejo plod vrtnega janeža
English: What is aniseed?
Slovenian: Kaj je plod vrtnega janeža?
English: Aniseed
Slovenian: delavcem.
English: Date of first authorisation: 11 November 2003 Date of latest renewal: 22 September 2008
Slovenian: Datum prve odobritve: 11. november 2003 Datum zadnjega podaljšanja: 22. september 2008
English: The storage details, should you need them, are as follows:
Slovenian: Pogoji shranjevanja, če bi jih potrebovali, so naslednji:
English: Time (hours)
Slovenian: Čas (ure) Time (hours)
English: No new safety concerns were identified.
Slovenian: Novih zadržkov glede varnosti niso ugotovili.
English: (IUDs) that release hormones.
Slovenian: (IUD), ki sproščajo hormone.
English: However, the data from this small study do not support a conclusion on the optimal dosing regimen.
Slovenian: Vendar podatki iz te majhne študije ne podpirajo sklepa o optimalni shemi odmerjanja.
English: Statistically significant differences in efficacy were also observed in each of the 2 individual studies.
Slovenian: Statistično pomembne razlike v učinkovitosti so sicer opazili v vsaki od obeh študij.
English: **N: Number of patients included in the primary analysis of complete response.
Slovenian: **N: Število bolnikov, vključenih v primarno analizo popolnega odziva.
English: The median tmax was 3.0 hours.
Slovenian: Srednji tmax je bil 3,0 ure.
English: This is normal and the medicine is okay to use.
Slovenian: To je normalno in zdravilo se lahko uporabi.
English: It is very important that this medicine is given exactly as directed below.
Slovenian: Zelo pomembno je, da se to zdravilo daje natančno po navodilih spodaj.
English: The majority of adults were women (> 90 %), mainly undergoing gynaecological surgery.
Slovenian: Večina odraslih je bila žensk (> 90 %), pretežno po prestanih ginekoloških operativnih posegih.
English: The results were evaluated for each individual study and for the 2 studies combined.
Slovenian: Rezultate so ovrednotili za vsako posamezno študijo ter za kombinacijo obeh študij.
English: 25-120 hours
Slovenian: 25-120 ur
English: This medicine can affect other medicines.
Slovenian: To zdravilo lahko vpliva na druga zdravila.
English: Make sure no air is in the oral dispenser (if air is present, remove).
Slovenian: Prepričajte se, da v odmerniku ni zraka (če je zrak prisoten, ga odstranite).
English: These may not work properly when taken with this medicine.
Slovenian: Možno je, da ta sredstva med jemanjem tega zdravila ne delujejo ustrezno.
English: Differences*
Slovenian: Razlike*
English: Summary of the safety profile The safety profile of aprepitant was evaluated in approximately 6,500 adults.
Slovenian: Povzetek varnostnega profila Varnostne značilnosti aprepitanta so ocenili pri približno 6.500 odraslih.
English: Other side effects that have been reported are listed below.
Slovenian: Ostali neželeni učinki, o katerih so poročali, so navedeni spodaj.
English: Unopened sachet: 2 years
Slovenian: Neodprta vrečka: 2 leti
English: The efficacy of the aprepitant regimen was apparently maintained during all cycles.
Slovenian: Učinkovitost aprepitanta se je očitno ohranjala v vseh ciklusih.
English: *Reported in patients taking a higher dose of aprepitant.
Slovenian: *Poročano pri bolnikih, ki jemljejo večji odmerek aprepitanta.
English: - If there is any foam, wait for the foam to disappear before going on to Step 9.
Slovenian: - Če je prisotna pena, počakajte, da pena izgine, preden nadaljujete z 9. korakom.
English: Aprepitant is not excreted unchanged in urine.
Slovenian: Aprepitant se ne izloča nespremenjen z urinom.
English: The terminal half-life ranged from approximately 9 to 13 hours.
Slovenian: Končni razpolovni čas je znašal v razponu od približno 9 do 13 ur.
English: - It is common to have medicine leftover in the cup.
Slovenian: - Običajno je, da nekaj zdravila ostane v čaši.
English: To prevent foaming, do not shake the mixing cup.
Slovenian: Da preprečite penjenje, ne stresajte čaše za mešanje.
English: Complete response (0-24 hours)
Slovenian: Popoln odziv (0-24 ur)
English: The efficacy of the aprepitant regimen was evaluated in a single cycle (Cycle 1).
Slovenian: Učinkovitost sheme z aprepitantom so ocenili v enem samem ciklusu (1. ciklus).
English: Do not remove all capsules at one time.
Slovenian: Ne odstranite vseh kapsul iz ovojnine naenkrat.
English: Frequencies are defined as: 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), not known (cannot be estimated from the available data).
Slovenian: Pogostnost je opredeljena kot: zelo pogosti (≥ 1/10); pogosti (≥ 1/100 do < 1/10); občasni (≥ 1/1.000 do < 1/100); redki (≥ 1/10.000 do < 1/1.000) in zelo redki (< 1/10.000), neznana (ni mogoče oceniti iz razpoložljivih podatkov).
English: Adolescents (aged 12 through 17 years)
Slovenian: Mladostniki (stari od 12 do 17 let)
English: Both clearance and absolute bioavailability decrease with increasing dose.
Slovenian: Tako očistek kot absolutna biološka uporabnost se zmanjšujeta z večanjem odmerka.
English: †Difference and confidence interval (CI) were calculated using the method proposed by Miettinen and Nurminen and adjusted for Gender.
Slovenian: †Razlika in interval zaupanja (IZ) sta bila izračunana z uporabo metode po Miettinenu in Nurminenu in sta bila prilagojena glede na spol.
English: Patients had the opportunity to receive open-label aprepitant in subsequent cycles (Optional Cycles 2-6); however efficacy was not assessed in these optional cycles.
Slovenian: Bolniki so imeli možnost v naslednjih ciklusih (na izbiro od 2. do 6. ciklusa) odprto prejemati aprepitant, vendar učinkovitosti v teh neobveznih ciklusih niso ocenili.
English: Aprepitant is excreted in the milk of lactating rats.
Slovenian: Aprepitant se izloča v mleko podgan.
English: Do not remove the capsule from its blister until you are ready to take it.
Slovenian: Kapsule ne vzemite iz pretisnega omota, dokler je ne nameravate zaužiti.
English: The geometric mean apparent volume of distribution at steady state (Vdss) is approximately 66 L in humans.
Slovenian: Geometrični srednji navidezni volumen porazdelitve v stanju dinamičnega ravnovesja (Vdss) je pri ljudeh približno 66 l.
English: * - Delayed phase
Slovenian: * - zapoznela faza
English: * - Acute phase
Slovenian: * - akutna faza
English: Any unused medicinal product or waste material should be disposed of in accordance with local regulations.
Slovenian: Neuporabljeno zdravilo ali odpadni material zavrzite v skladu z lokalnimi predpisi.
English: 1-day regimen of fosaprepitant 150 mg in adults
Slovenian: 1-dnevni režim zdravljenja s fosaprepitantom 150 mg pri odraslih
English: Additionally, concomitant administration with irinotecan should be approached with particular caution as the combination might result in increased toxicity.
Slovenian: Poleg tega je posebna previdnost potrebna pri sočasni uporabi irinotekana, saj lahko kombinacija poveča toksični učinek.
English: The color of the medicine in the oral dispenser may be different shades of pink (light pink to dark pink).
Slovenian: Barva zdravila v odmerniku je lahko različen odtenek rožnate (svetlo do temno rožnat).
English: - if the child is using medicines that contain ‘pimozide' (for mental health problems).
Slovenian: - če otrok uporablja zdravila, ki vsebujejo pimozid (za težave z duševnim zdravjem).
English: The safety profile of aprepitant was evaluated in approximately 6,500 adults in more than 50 studies and 184 children and adolescents in 2 pivotal paediatric clinical trials.
Slovenian: Varnostne značilnosti aprepitanta so ocenili pri približno 6.500 odraslih v več kot 50 študijah ter 184 otrocih in mladostnikih v 2 kontroliranih pediatričnih kliničnih preskušanjih.
English: WHEN:
Slovenian: KDAJ:
English: WHEN and HOW to take EMEND
Slovenian: KDAJ in KAKO jemati zdravilo EMEND
English: Pharmacotherapeutic group: Antiemetics and antinauseants, ATC code: A04AD12
Slovenian: Farmakoterapevtska skupina: Antiemetiki in zdravila proti slabosti, oznaka ATC: A04AD12
English: • For more details on preparation and administration of the suspension, see the package leaflet and the instructions for preparation of the oral suspension for healthcare professionals.
Slovenian: • Za podrobnosti o pripravi in uporabi suspenzije glejte Navodilo za uporabo in navodila za pripravo peroralne suspenzije za zdravstveno osebje.
English: Healthcare professionals: See the instructions for preparation of the oral suspension for healthcare professionals at the end of this package leaflet.
Slovenian: Zdravstveno osebje: Glejte navodila za pripravo peroralne suspenzije za zdravstveno osebje na koncu tega Navodila za uporabo.
English: The safety and exploratory efficacy of aprepitant were evaluated in a Phase I clinical study (n=50) using a 40 mg powder for oral suspension.
Slovenian: Varnost in učinkovitost aprepitanta so ocenili v klinični študiji I. faze (n = 50) z uporabo 40 mg praška za peroralno suspenzijo.
English: * - Overall phase
Slovenian: * - celotna faza