FrancophonIA/ELRC3.0 huggingface dataset:
English: Patients and healthcare professionals are therefore advised to take extra care when using these medicines and carefully follow the recommendations given below.
Slovenian: Bolnikom in zdravstvenim delavcem zato svetujemo, da so pri uporabi teh zdravil posebno previdni in da skrbno upoštevajo spodaj navedena priporočila.
English: • Ensure that your patients are adequately informed on how to use their medicine.
Slovenian: • Poskrbite, da so vaši bolniki ustrezno seznanjeni s tem, kako morajo uporabljati svoje zdravilo.
English: These types of combination medicines are advantageous to patients since they reduce the number of injections they need to have and may help them keep to their treatment.
Slovenian: Tovrstna kombinirana zdravila so za bolnike ugodna, ker zmanjšujejo število potrebnih injekcij in jim pomagajo, da se držijo zdravljenja.
English: • If you have any questions about your treatment speak to your healthcare professional.
Slovenian: • Če imate kakršna koli vprašanja o zdravljenju, se posvetujte z zdravstvenim delavcem.
English: Before you use your medicine be clear on how many dose steps you require.
Slovenian: Pred uporabo zdravila morate vedeti, koliko odmernih korakov potrebujete.
English: However, there is a potential risk of patients receiving too little or too much of their medicine because of confusion that may arise over the way the doses are expressed for the individual components − the dose of the insulin is expressed in units while the dose of the non-insulin medicine may be expressed in other units such as mg.
Slovenian: Vendar pa obstaja potencialno tveganje, da bolniki prejmejo premalo ali preveč zdravila zaradi zmede, ki se lahko pojavi zaradi načina izražanja odmerkov posameznih komponent − odmerek insulina je izražen v enotah, odmerek neinsulinskega zdravila pa v drugih enotah, na primer v miligramih.
English: An example of a diabetes medicine that contains insulin in combination with a non-insulin active substance is Xultophy (100 units/ml insulin degludec and 3.6 mg/ml liraglutide) which was authorised in the EU on.
Slovenian: Primer zdravila za sladkorno bolezen, ki vsebuje insulin v kombinaciji z neinsulinsko zdravilno učinkovino, je zdravilo Xultophy (100 enot/ml insulina degludek in 3,6 mg/ml liraglutida), ki je bil v EU odobren dne.
English: Further information on the safe use of these medicines and other ways to minimise the possible risk of medication errors, can be found in the guidance on risk minimisation strategies for high strength and fixed combination insulin products.
Slovenian: Več informacij o varni uporabi teh zdravil in drugih načinih zmanjševanja morebitnih tveganj za napake pri zdravljenju je na voljo v navodilu o strategijah zmanjševanja tveganja za insulinska zdravila z veliko jakostjo in v fiksnih kombinacijah.
English: Always prescribe the dose of insulin and the dose of non-insulin to be injected as well as the dose frequency.
Slovenian: Vedno predpišite odmerek insulina in odmerek neinsulinske učinkovine, ki ju je treba injicirati, ter pogostnost odmerjanja.
English: • If the patient has been transferred from another pen device, highlight the differences in design between the two devices.
Slovenian: • Če je bolnik prej uporabljal drug peresnik, poudarite razlike v zasnovi med peresnikoma.
English: • One dose step contains a set number of units of insulin plus a fixed amount of the non-insulin medicine.
Slovenian: • En odmerni korak vsebuje določeno število enot insulina in nespremenljivo količino neinsulinskega zdravila.
English: In addition, healthcare professionals are encouraged to take the following precautions when storing, prescribing and dispensing diabetes medicines that contain insulin in combination with a non-insulin active substance:
Slovenian: Poleg tega zdravstvenim delavcem priporočamo tudi, da pri shranjevanju, prepisovanju in izdajanju zdravila za sladkorno bolezen, ki vsebujejo insulin v kombinaciji z neinsulinsko zdravilno učinkovino, upoštevajo naslednje previdnostne ukrepe:
English: • Your healthcare professional will explain the design and features of your pen, including how the dose counter of the pen device shows the number of dose steps to be injected.
Slovenian: • Zdravnik vam bo pojasnil tudi zasnovo in lastnosti peresnika, vključno s tem, kako števec odmerkov na peresniku prikazuje število odmernih korakov, ki si jih boste injicirali.
English: Recently, diabetes medicines that contain insulin in combination with a non-insulin active substance have been approved in the EU.
Slovenian: Pred kratkim so bila v EU odobrena zdravila za sladkorno bolezen, ki vsebujejo insulin v kombinaciji z neinsulinsko zdravilno učinkovino.
English: • Explain to your patient that the dose counter of the pen device shows the number of dose steps to be injected.
Slovenian: • Bolniku pojasnite, da števec odmerkov na peresniku prikazuje število odmerkov, ki si jih bo injiciral.
English: • Tell patients to closely monitor their blood sugar levels when starting a medicine containing insulin and a non-insulin active substance and in the weeks after.
Slovenian: • Bolnikom povejte, naj ob začetku zdravljenja z zdravilom, ki vsebuje insulin in neinsulinsko zdravilno učinkovino, skrbno spremljajo krvni sladkor.
English: • Pharmacists are encouraged to check that patients and carers are able to read the dose counter of the pen device before dispensing the medicine.
Slovenian: • Farmacevtom priporočamo, da pred izdajo zdravila preverijo, ali bolniki in negovalci lahko odčitajo števec odmerkov na peresniku.
English: EU Number Invented Name
Slovenian: Izmišljeno ime
English: Date of first authorisation: 14/04/2003 Date of last renewal: 11/03/2008
Slovenian: Datum pridobitve dovoljenja za promet: 14/04/2003 Datum podaljšanja dovoljenja za promet: 11/03/2008
English: Manufacturing authorisation issued by the French Ministère des Affaires Sociales, Ministère délégué à la Santé, and the Ministère de l'Agriculture et de la Forêt on 31 March 1992.
Slovenian: Dovoljenje za proizvodnjo je izdalo francosko Ministère des Affaires Sociales (Ministrstvo za socialne zadeve), Ministère délégué à la Santé (Ministrstvo pristojno za zdravstvo) in Ministère de l'Agriculture et de la Forêt (Ministrstvo za kmetijstvo in gozdarstvo) 31. marca 1992.
English: No special precautions.
Slovenian: Ni posebnih previdnostnih ukrepov.
English: Annex II of Council Regulation (EEC) No 2377/90 Pharmacologically active substance(s)
Slovenian: Dodatek II k Uredbi Sveta (EGS) Št. 2377/90 Farmakološko aktivna(e)
English: 5 to 7 weeks before farrowing
Slovenian: 5-7 tednov pred prasitvijo
English: 50 dose
Slovenian: 50 odmerkov
English: Laboratoire de Toulouse 4 Chemin du Calquet 31300 TOULOUSE FRANCE
Slovenian: Laboratoire de Toulouse 4 Chemin de Calquet 31300 TOULOUSE FRANCIJA
English: Vaccination may cause a slight hyperthermia (less than 1.5°C during a maximum period of 24 hours).
Slovenian: Cepljenje lahko povzroči rahel dvig telesne temperature ( manj kot 1,5oC v obdobju do največ 24 ur).
English: Wash and disinfect hands after use.
Slovenian: Po uporabi si umijte in razkužite roke.
English: Do not mix with any other vaccine.
Slovenian: Ne mešajte z nobenim drugim cepivom.
English: Therefore the safety and efficacy of this product when used with any other (either when used on the same day or at different times) has not been demonstrated.
Slovenian: Tako varnost in učinkovitost tega cepiva ob sočasni uporabi s katerikoli drugim cepivom (uporabljenim isti dan ali ob drugem času) nista potrjeni.
English: No information is available on the compatibility of this vaccine with any other.
Slovenian: Ni podatkov o sočasni uporabi tega cepiva s katerim koli drugim cepivom.
English: - Since the protection of piglets is ensured by colostrum intake, each piglet should ingest a sufficient quantity of colostrum within 6 hours of birth.
Slovenian: - Ker zaščito pujskov zagotavlja zaužitje kolostruma, bi moral vsak pujsek zaužiti zadostno količino kolostruma v prvih šestih urah po rojstvu.
English: In sows and gilts, the vaccine induces the specific seroconversion of vaccinated animals; piglets are passively immunised by intake of colostrum and milk containing adhesin-specific antibodies.
Slovenian: Pri svinjah in mladicah cepivo sproži specifično serokonverzijo cepljenih živali; pujski se pasivno imunizirajo z zaužitjem kolostruma in mleka, ki vsebuje specifična protitelesa proti adhezinom.
English: 1 OJ No L 290 of 05.12.95 2 OJ No L 110 of 26.04.97 3 OJ No L 272 of 25.10.96 4 OJ No L 290 of 05.12.95 5 OJ No L 143 of 27.06.95
Slovenian: 1UL št L 290 z dne 05.12.95 2UL št L 110 z dne 26.04.97 3UL št L 272 z dne 25.10.96 4UL št L 290 z dne 05.12.95 5UL št L 143 z dne 27.06.95
English: - Vaccinate only healthy animals.
Slovenian: - Cepite le zdrave živali.
English: No undesirable effects have been observed after the administration of twice the recommended dosage.
Slovenian: Po vnosu dvakratnega priporočenega odmerka se niso pojavili nobeni neželeni učinki.
English: In the case of accidental self-injection, seek medical advice immediately and show the package insert or label to a physician.
Slovenian: V primeru nenamernega samo-injiciranja se takoj posvetujte z zdravnikom in mu pokažite navodila za uporabo ali nalepko na zunanji ovojnini.
English: All food producing species
Slovenian: Vse živali za proizvodnjo živil
English: Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with the local requirements
Slovenian: Vsako neporabljeno zdravilo ali odpadne snovi, ki nastanejo iz teh zdravil, je treba odstraniti v skladu z nacionalnimi zahtevami.
English: Name and address of the manufacturer of the biological active substance
Slovenian: Ime in naslov proizvajalca biološko aktivne učinkovine
English: One 2 ml dose according to the following schedule: Primary vaccination:
Slovenian: En 2 ml odmerek po naslednjem razporedu: Primarno cepljenje:
English: Revaccination: 1 injection 2 weeks before each subsequent farrowing.
Slovenian: Revakcinacija: 1 odmerek dva tedna pred vsako naslednjo prasitvijo.
English: Use sterile syringe and needles.
Slovenian: Uporabljajte sterilne brizge in igle.
English: Shelf-life: 18 months at 2 - 8 °C.
Slovenian: Rok uporabnosti: 18 mesecev pri temperaturi 2- 8 oC
English: Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency https://www.ema.europa.eu/
Slovenian: Podrobne informacije o tem zdravilu za uporabo v veterinarski medicini so na voljo na spletni strani Evropske agencije za zdravila http://ema.europa.eu
English: Laboratoire Porte des Alpes Rue de l'Aviation F-69800 SAINT PRIEST
Slovenian: Laboratoire Porte des Alpes Rue de l'Aviation F-69800 SAINT PRIEST FRANCIJA
English: One 2 ml dose intramuscularly in the neck in the area behind the ear, according to the following schedule:
Slovenian: En 2 ml odmerek intramuskularno v področje vratu za ušesom po naslednjem razporedu:
English: - Do not administer in conjunction with other medicinal products.
Slovenian: Ne uporabljajte skupaj z drugimi zdravili.
English: 2 weeks before farrowing.
Slovenian: 2 tedna pred prasitvijo
English: Broached vial: 3 hours.
Slovenian: Načeta viala: 3 ure
English: Store and transport at 2°C - 8°C, protected from light.
Slovenian: Shranjujte in prevažajte pri temperaturi 2°C - 8°C, zaščiteno pred svetlobo.
English: *: 1 SA.U: quantity sufficient to obtain an agglutinating antibody titre of 1 log10 in the guinea pig.
Slovenian: *: 1 SA.U: količina, ki zadošča za doseganje aglutinacijskega titra protiteles 1 log10 pri morskem prašičku
English: MARKETING AUTHORISATION HOLDER Boehringer Ingelheim Vetmedica GmbH 55216 Ingelheim/Rhein GERMANY
Slovenian: IMETNIK DOVOLJENJA ZA PROMET Z ZDRAVILOM Boehringer Ingelheim Vetmedica GmbH 55216 Ingelheim/Rhein
English: Intramuscular injection
Slovenian: Intramuskularno injiciranje
English: Intramuscular injection in the neck in the area behind the ear.
Slovenian: Intramuskularno injiciranje v področje vratu za ušesom Pred uporabo dobro pretresite vialo.
English: Administer using aseptic procedures.
Slovenian: Injicirajte v skladu z aseptičnimi pravili.
English: Adhesins:
Slovenian: Dodatek:
English: All food producing species For use only as a preservative in multidose vaccines at a concentration not exceeding 0.02%
Slovenian: Uporablja se le kot zaščitno sredstvo za večodmerna cepiva, koncentracija ne sme preseči
English: 4.2 Indications for use specifying the target species
Slovenian: 4.2 Indikacije za uporabo pri ciljnih živalskih vrstah
English: Adhesins: F4 (F4ab, F4ac, F4ad), F5, F6, F41 Aluminium adjuvant
Slovenian: adhezini F4 (F4ab, F4ac, F4ad), F5, F6, F41 Aluminijski adjuvant
English: Primary vaccination:
Slovenian: Primarno cepljenje: Prvi odmerek:
English: Aluminium hydroxide1
Slovenian: Aluminijev hidroksid1
English: First injection:
Slovenian: Prvi odmerek:
English: MANUFACTURER FOR THE BATCH RELEASE MERIAL
Slovenian: PROIZVAJALEC ZA SPROSTITEV SERIJ MERIAL
English: Second injection:
Slovenian: Drugi odmerek:
English: B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
Slovenian: POGOJI TER OMEJITVE GLEDE OSKRBE IN UPORABE
English: Shelf life of broached vial: 3 hours.
Slovenian: Rok uporabnosti za načeto vialo: 3 ure.
English: Thiomersal2
Slovenian: Tiomersal2
English: Sodium hydroxide3
Slovenian: Natrijev hidroksid3
English: A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE
Slovenian: A. PROIZVAJALEC BIOLOŠKE UČINKOVINE IN IMETNIK(I) DOVOLJENJA ZA
English: Thiomersal Aluminium hydroxide Sodium chloride
Slovenian: Aluminijev hidroksid Natrijev hidroksid
English: 250 doses =100 ml vial.
Slovenian: 250 odmerkov = 100 ml steklena viala.
English: Sodium chloride4
Slovenian: Natrijev klorid3
English: Neocolipor suspension for injection
Slovenian: Neocolipor suspenzija za injiciranje
English: 5 doses = 10 ml vial.
Slovenian: 5 odmerkov = 10 ml steklena viala.
English: Adjuvanted inactivated vaccine for the reduction of neonatal enterotoxicosis of piglets, caused by E. coli strains, expressing the adhesins F4ab, F4ac, F4ad, F5, F6 and F41.
Slovenian: Inaktivirano cepivo z dodatkom (adjuvansom) za zmanjšanje pojava poporodne enterotoksemije pri pujskih, ki jo povzročajo sevi bakterije E. coli, ki izločajo adhezine F4ab, F4ac, F4ad, F5, F6 in F41.
English: Manufacturer responsible for batch release
Slovenian: Proizvajalec odgovoren za sprostitev serije
English: 2 ml = 1 dose 10 d
Slovenian: 2 ml= 1 odmerek, 10 odmerkov
English: E. coli adhesin F4 (F4ab, F4ac, F4ad), at least....................................................... 2.1 SA U* E. coli adhesin F5, at least ...................................................................................... 1.7 SA.U* E. coli adhesin F6, at least ...................................................................................... 1.4 SA.U* E. coli adhesin F41, at least .................................................................................... 1.7 SA.U*
Slovenian: E.coli adhezin F4 (F4ab, F4ac, F4ad), najmanj ..................................................... 2,1 SA.U** E.coli adhezin F5, najmanj ..................................................................................... 1,7 SA.U* E.coli dhezin F6, najmanj ....................................................................................... 1,4 SA.U* E.coli adhezin F41, najmanj ................................................................................... 1,7 SA.U*
English: Other provisions
Slovenian: Druga določila
English: DATE OF FIRST RENEWAL OF THE AUTHORISATION
Slovenian: DATUM ZADNJE REVIZIJE NAVODIL ZA UPORABO
English: Hydrochloric acid5
Slovenian: Klorovodikova kislina5
English: 2 ml = 1 dose 5d
Slovenian: 2 ml =1 odmerek, 5 odmerkov
English: Neocolipor
Slovenian: Tiomersal
English: 20 ml vial
Slovenian: 20 ml steklena viala.
English: 100 ml vial
Slovenian: 100 ml steklena viala.
English: Shake the vial vigorously prior to use.
Slovenian: Vialo pred uporabo dobro pretresite.
English: 10 ml vial
Slovenian: 10 ml steklena viala.
English: Reduction of neonatal enterotoxicosis of piglets, caused by E. coli strains, expressing the adhesins F4ab, F4ac, F4ad, F5, F6 and F41, during the first days of life.
Slovenian: Zmanjšanje pojava poporodne enterotoksemije pujskov v obdobju prvih nekaj dni po porodu, ki jo povzročajo sevi bakterije E.coli, ki izločajo adhezine F4ab, F4ac, F4ad, F5, F6 in F41.
English: EU/2/98/008/004 100 ml vial.
Slovenian: EU/2/98/008/004 100 ml steklena viala.
English: The vaccine contains the inactivated strains of E. coli expressing the adhesins F4ab, F4ac, F4ad, F5, F6 and F41, which cause neonatal enterotoxicosis in piglets, in aluminium hydroxide adjuvant.
Slovenian: Ti sevi bakterije E.coli izločajo adhezine F4ab, F4ac, F4ad, F5, F6 in F41, ki povzročajo poporodno enterotoksemijo pujskov.
English: EU/2/98/008/001 10 ml vial.
Slovenian: EU/2/98/008/001 10 ml steklena viala.
English: 10 doses = 20 ml vial.
Slovenian: 2 ml= 1 odmerek, 10 odmerkov = 20 ml steklena viala.
English: Aluminium (as hydroxide) .................................................................................... 1.4 mg
Slovenian: Aluminij (v hidroksidni obliki) .............................................................................. 1,4 mg
English: E. coli adhesin F4 (F4ab, F4ac, F4ad), at least….2.1 SA.U* E. coli adhesin F5, at least………………………1.7 SA.U* E. coli adhesin F6, at least………………………1.4 SA.U* E. coli adhesin F41, at least…………………….1.7 SA.U* *: 1 SA.U: quantity sufficient to obtain an agglutinating antibody titre of 1 log10 in the guinea pig.
Slovenian: E.coli adhezin F4 (F4ab, F4ac, F4ad), najmanj ........................................................... 2,1 SA U* E.coli adhezin F5, najmanj .......................................................................................... 1,7 SA.U* E.coli adhezin F6, najmanj .......................................................................................... 1,4 SA.U* E.coli adhezin F41, najmanj ........................................................................................ 1,7 SA.U*
English: Veterinary medicinal product subject to prescription.
Slovenian: Oskrba le na podlagi veterinarskega recepta.
English: EU/2/98/008/002 20 ml vial.
Slovenian: EU/2/98/008/002 20 ml steklena viala.
English: EU/2/98/008/003 50 ml vial.
Slovenian: EU/2/98/008/003 50 ml steklena viala.
English: Aluminium (as hydroxide) ..................................................................................... 1.4 mg
Slovenian: Dodatek: Aluminij (v hidroksidni obliki) ........................................................................ 1,4 mg
English: Shake the vial vigorously before use.
Slovenian: Pred uporabo dobro pretresite vialo.
English: PACKAGE LEAFLET Neocolipor
Slovenian: NAVODILO ZA UPORABO Neocolipor
English: MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE
Slovenian: IMETNIK DOVOLJENJA ZA IZDELAVO ZDRAVILA, ODGOVOREN ZA SPROSTITEV SERIJE
English: Box of 25-dose 50 ml vial (glass type I vial with butyl rubber stopper).
Slovenian: Škatla z vialo z 10 ml - pet odmerkov (steklo tipa I z butil gumenim zamaškom) Škatla z vialo z 20 ml - deset odmerkov (steklo tipa I z butil gumenim zamaškom) Škatla z vialo s 50 ml - petindvajset odmerkov (steklo tipa I z butil gumenim zamaškom) Škatla z vialo s 100 ml - petdeset odmerkov (steklo tipa I z butil gumenim zamaškom)
English: 25 doses = 50 ml vial.
Slovenian: 2 ml = 1 odmerek, 25 odmerkov 50 ml steklena viala.
English: DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED
Slovenian: NAVEDBA NAJVIŠJIH DOVOLJENIH KOLIČIN ZAOSTANKOV
English: CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION WITH REGARD TO SAFE AND EFFECTIVE USE
Slovenian: VARNE IN UČINKOVITE UPORABE
English: CI=Confidence Interval
Slovenian: CI = interval zaupanja
English: 1-year Overall Survival (%)
Slovenian: 1-letno celokupno preživetje (%)
English: Response rate n: response-evaluable patients
Slovenian: Stopnja odziva n: odgovor preiskovanih bolnikov
English: This medicine must not be used in children and adolescents because it is not known how it will affect them.
Slovenian: Otroci in mladostniki Bortezomib se pri otrocih in mladostnikih ne sme uporabljati, ker njegovega vpliva nanje ne poznamo.
English: n: ITT patients Progression free survival (IRC)
Slovenian: n: bolniki (ITT) Preživetje brez napredovanja bolezni (IRC)
English: MARKETING AUTHORISATION NUMBER(S) EU/1/19/1397/001
Slovenian: ŠTEVILKA DOVOLJENJA ZA PROMET EU/1/19/1397/001
English: Table 14: Summary of disease outcomes from the Phase III (APEX) and Phase II studies Phase III
Slovenian: Preglednica 14: Povzetek izidov bolezni v študijah faze III (APEX) in II faza III
English: For dose adjustments, see table 5 below.
Slovenian: Za prilagajanje odmerkov glejte spodnjo preglednico 5.
English: This medicinal product does not require any special temperature storage condition.
Slovenian: Za shranjevanje zdravila ni posebnih temperaturnih omejitev.
English: AST=aspartate aminotransferase; ULN=upper limit of the normal range.
Slovenian: AST = aspartat-aminotransferaza; ULN - upper limit of the normal range = zgornja meja razpona normalnih vrednosti.
English: The requirements for submission of PSURs for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.>
Slovenian: Redno posodobljena poročila o varnosti zdravila (PSUR) Zahteve glede predložitve PSUR za to zdravilo so določene v seznamu referenčnih datumov EU (seznamu EURD), opredeljenem v členu 107c(7) Direktive 2001/83/ES, in vseh kasnejših posodobitvah, objavljenih na evropskem spletnem portalu o zdravilih.
English: The median survival of all patients enrolled was 17 months (range < 1 to 36+ months).
Slovenian: Mediana preživetja vseh bolnikov, vključenih v raziskavo je bila 17 mesecev (območje < 1 do 36+ mesecev).
English: This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.
Slovenian: Zdravila ne smete mešati z drugimi zdravili, razen s tistimi, ki so omenjena v poglavju 6.6. 6.3 Rok uporabnosti
English: You must tell your doctor if you have any of the following:
Slovenian: Zdravniku povejte, če:
English: a Based on Independent Review Committee (IRC) assessment (radiological data only).
Slovenian: Na osnovi ocene neodvisnega odbora (Independent Review Committee-IRC) (samo podatki slikovnih diagnostičnih metod).
English: Do not use this medicine after the expiry date stated on the vial and the carton after EXP.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na viali in škatli poleg oznake EXP.
English: Bortezomib must be reconstituted by a healthcare professional (see section 6.6).
Slovenian: Bortezomib mora rekonstituirati zdravstveno osebje (glejte poglavje 6.6).
English: The AUClast geometric mean ratio was 0.99 and 90% confidence intervals were 80.18%-122.80%.
Slovenian: Stopnja geometrične sredine AUCzadnji je bila 0,99 in 90 % intervali zaupanja 80,18 %-122,80 %.
English: Very common Decreased appetite Common
Slovenian: Zelo pogosti zmanjšan apetit
English: From a microbiological point of view, the reconstituted solution should be used immediately after preparation.
Slovenian: Z mikrobiološkega stališča je rekostituirano raztopino treba porabiti takoj po pripravi.
English: Cycle 1
Slovenian: cikel 1
English: Grade 1 (asymptomatic; loss of deep tendon reflexes or paresthesia) with no pain or loss of function
Slovenian: Stopnja 1 (asimptomatična; izguba refleksa globoke tetive ali parestezija) brez bolečine ali izgube funkcije ni potrebna
English: Median duration Days (months)
Slovenian: Mediana trajanja odziva dnevi (meseci)