FrancophonIA/ELRC3.0 huggingface dataset:
English: No dosage adjustment of Irbesartan Hydrochlorothiazide Zentiva is necessary inolder people.
Slovenian: Pri starostnikih odmerka zdravila Irbesartan Hydrochlorothiazide Zentiva ni treba prilagajati.
English: Irbesartan Hydrochlorothiazide Zentiva 300 mg/12.5 mg film-coated tablets are supplied in blister packs of 14, 28, 30, 56, 84, 90 or 98 film-coated tablets.
Slovenian: Irbesartan Hydrochlorothiazide Zentiva 300 mg/12,5 mg filmsko obložene tablete so na voljo v pretisnih omotih s 14, 28, 30, 56, 84, 90 ali 98 filmsko obloženimi tabletami.
English: NAME OF THE MEDICINAL PRODUCT Irbesartan Hydrochlorothiazide Zentiva 300 mg/25 mg film-coated tablets.
Slovenian: Irbesartan Hydrochlorothiazide Zentiva 300 mg/25 mg filmsko obložene tablete
English: Irbesartan Hydrochlorothiazide Zentiva 300 mg/25 mg film-coated tablets irbesartan/hydrochlorothiazide
Slovenian: Irbesartan Hydrochlorothiazide Zentiva 300 mg/25 mg filmsko obložene tablete irbesartan/hidroklorotiazid
English: Conversely, due to the irbesartan component of Irbesartan Hydrochlorothiazide Zentiva hyperkalaemia might occur, especially in the presence of renal impairment and/or heart failure, and diabetes mellitus.
Slovenian: Nasprotno pa se lahko zaradi irbesartana, ki ga vsebuje zdravilo Irbesartan Hydrochlorothiazide Zentiva, pojavi hiperkaliemija,
English: While this is not documented with Irbesartan Hydrochlorothiazide Zentiva, a similar effect should be anticipated.
Slovenian: Podoben učinek bi lahko pričakovali pri zdravljenju z zdravilom Irbesartan Hydrochlorothiazide Zentiva, čeprav to pri zdravljenju z njim ni bilo dokazano.
English: Each tablet of Irbesartan Hydrochlorothiazide Zentiva 300 mg/12.5 mg contains 300 mg irbesartan and 12.5 mg hydrochlorothiazide.
Slovenian: Zentiva 300 mg/12,5 mg tableta vsebuje 300 mg irbesartana in 12,5 mg hidroklorotiazida.
English: What Irbesartan Hydrochlorothiazide Zentiva contains The active substances are irbesartan and hydrochlorothiazide.
Slovenian: Zdravilni učinkovini sta irbesartan in hidroklorotiazid.
English: • Irbesartan Hydrochlorothiazide Zentiva 150 mg/12.5 mg may be administered in patients whose blood pressure is not adequately controlled with hydrochlorothiazide or irbesartan 150 mg alone;
Slovenian: Kadar je klinično primerno, se lahko razmisli o prehodu iz monoterapije na kombinirano zdravljenje: Zdravilo Irbesartan Hydrochlorothiazide Zentiva 150 mg/12,5 mg je namenjeno bolnikom, pri katerih se zvišan krvni tlak med zdravljenjem samo s hidroklorotiazidom ali samo s 150 mg irbesartana ni dovolj znižal.
English: Irbesartan Hydrochlorothiazide Zentiva 150 mg/12.5 mg film-coated tablets irbesartan/hydrochlorothiazide
Slovenian: Irbesartan Hydrochlorothiazide Zentiva 150 mg/12,5 mg filmsko obložene tablete irbesartan/hidroklorotiazid
English: Package leaflet: Information for the patient Irbesartan Hydrochlorothiazide Zentiva 300 mg/25 mg film-coated tablets irbesartan/hydrochlorothiazide
Slovenian: Navodilo za uporabo Irbesartan Hydrochlorothiazide Zentiva 300 mg/25 mg filmsko obložene tablete irbesartan/hidroklorotiazid
English: Irbesartan Hydrochlorothiazide Zentiva 300 mg/12.5 mg film-coated tablets irbesartan/hydrochlorothiazide
Slovenian: Irbesartan Hydrochlorothiazide Zentiva 300 mg/12,5 mg filmsko obložene tablete irbesartan/hidroklorotiazid
English: Although not specifically studied with the Irbesartan Hydrochlorothiazide Zentiva, rebound hypertension has not been seen with either irbesartan or hydrochlorothiazide.
Slovenian: Hydrochlorothiazide Zentiva ni, kljub temu pa povratnega zvišanja krvnega tlaka pri bolnikih, ki so jemali bodisi irbesartan bodisi hidroklorotiazid, po prenehanju jemanja zdravila niso opazili.
English: • Irbesartan Hydrochlorothiazide Zentiva 300 mg/12.5 mg may be administered in patients insufficiently controlled by irbesartan 300 mg or by Irbesartan Hydrochlorothiazide
Slovenian: Zdravilo Irbesartan Hydrochlorothiazide Zentiva 300 mg/12,5 mg je namenjeno bolnikom, pri katerih se krvni tlak med zdravljenjem s 300 mg irbesartana ali z zdravilom Irbesartan Hydrochlorothiazide Zentiva 150 mg/12,5 mg ni dovolj znižal.
English: NAME OF THE MEDICINAL PRODUCT Irbesartan Hydrochlorothiazide Zentiva 150 mg/12.5 mg film-coated tablets.
Slovenian: Irbesartan Hydrochlorothiazide Zentiva 150 mg/12,5 mg filmsko obložene tablete
English: Irbesartan Hydrochlorothiazide Zentiva is for oral use.
Slovenian: Irbesartan Hydrochlorothiazide Zentiva ni priporočljivo.
English: NAME OF THE MEDICINAL PRODUCT Irbesartan Hydrochlorothiazide Zentiva 300 mg/12.5 mg film-coated tablets.
Slovenian: Irbesartan Hydrochlorothiazide Zentiva 300 mg/12,5 mg filmsko obložene tablete
English: • Irbesartan Hydrochlorothiazide Zentiva 300 mg/25 mg may be administered in patients insufficiently controlled by Irbesartan Hydrochlorothiazide Zentiva 300 mg/12.5 mg. Doses higher than 300 mg irbesartan/25 mg hydrochlorothiazide once daily are not recommended.
Slovenian: Zdravilo Irbesartan Hydrochlorothiazide Zentiva 300 mg/25 mg je namenjeno bolnikom, pri katerih se krvni tlak med zdravljenjem z zdravilom Irbesartan Hydrochlorothiazide Zentiva 300 mg/12,5 mg ni dovolj znižal.
English: While hydrochlorothiazide is a sulfonamide, only isolated cases of acute angleclosure glaucoma have been reported so far with hydrochlorothiazide.
Slovenian: vendar pa so do sedaj med njegovo uporabo poročali le o posameznih primerih akutnega glavkoma z zaprtim zakotjem.
English: EU/1/06/377/017 - 14 tablets EU/1/06/377/018 - 28 tablets EU/1/06/377/031 - 30 tablets EU/1/06/377/019 - 56 tablets EU/1/06/377/020 - 56 x 1 tablets EU/1/06/377/021 - 84 tablets EU/1/06/377/032 - 90 tablets EU/1/06/377/022 - 98 tablets
Slovenian: EU/1/06/377/020 - 56 x 1 tableta EU/1/06/377/021 - 84 tablet
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 150 mg of irbesartan and 12.5 mg of hydrochlorothiazide.
Slovenian: Ena filmsko obložena tableta vsebuje 150 mg irbesartana in 12,5 mg hidroklorotiazida.
English: Package leaflet: Information for the patient Irbesartan Hydrochlorothiazide Zentiva 300 mg/12.5 mg tablets irbesartan/hydrochlorothiazide
Slovenian: Navodilo za uporabo Irbesartan Hydrochlorothiazide Zentiva 300 mg/12,5 mg tablete irbesartan/hidroklorotiazid
English: EU/1/06/377/023 - 14 tablets EU/1/06/377/024 - 28 tablets EU/1/06/377/033 - 30 tablets EU/1/06/377/025 - 56 tablets EU/1/06/377/026 - 56 x 1 tablets EU/1/06/377/027 - 84 tablets EU/1/06/377/034 - 90 tablets EU/1/06/377/028 - 98 tablets
Slovenian: EU/1/06/377/026 - 56 x 1 tableta EU/1/06/377/027 - 84 tablet
English: Package leaflet: Information for the patient Irbesartan Hydrochlorothiazide Zentiva 150 mg/12.5 mg tablets irbesartan/hydrochlorothiazide
Slovenian: Navodilo za uporabo Irbesartan Hydrochlorothiazide Zentiva 150 mg/12,5 mg tablete irbesartan/hidroklorotiazid
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 300 mg of irbesartan and 12.5 mg of hydrochlorothiazide.
Slovenian: Ena filmsko obložena tableta vsebuje 300 mg irbesartana in 12,5 mg hidroklorotiazida.
English: 120 (60 x 2) capsules (multipack)
Slovenian: 120 (60 x 2) kapsul (večkratno pakiranje)
English: Efficacy and safety were similar for both regimens.
Slovenian: Učinkovitost in varnost obeh režimov zdravljenja sta bili podobni.
English: A risk to the newborn/infant cannot be excluded.
Slovenian: Tveganja za novorojenčka/dojenčka ni mogoče izključiti.
English: There is no known reason for this.
Slovenian: Razlog za to ni znan.
English: Date of first authorisation: 22 August 2007 Date of latest renewal: 16 June 2017
Slovenian: Datum prve odobritve: 22. avgust 2007 Datum zadnjega podaljšanja: 16. junij 2017
English: In some cases you may need a blood transfusion.
Slovenian: V nekaterih primerih bo morda potrebna transfuzija krvi.
English: This pattern of treatment will normally be repeated every three weeks.
Slovenian: Takšen vzorec zdravljenja se običajno ponavlja vsake tri tedne.
English: • Signs of infection.
Slovenian: • Znaki okužbe.
English: If you feel tired or weak, do not drive, and do not use any tools or machines.
Slovenian: Če ste utrujeni ali slabotni, ne vozite vozil in ne upravljajte s stroji ali z orodji.
English: Your doctor will decide how many treatment cycles are required.
Slovenian: Vaš zdravnik bo odločil, koliko ciklusov zdravljenja potrebujete.
English: 4866 Unterach am Attersee Austria
Slovenian: 4866 Unterach am Attersee Avstrija
English: This includes spontaneous case reports as well as serious adverse events from ongoing studies.
Slovenian: Ta poročila vključujejo tako spontana poročila kot tudi resne neželene učinke iz študij, ki potekajo.
English: The following additional adverse reactions were seen:
Slovenian: Opaženi so bili naslednji dodatni neželeni učinki:
English: Blood tests during treatment
Slovenian: Krvne preiskave v času zdravljenja
English: The abnormal high number of white blood cells can appear in the blood and other parts of the body.
Slovenian: Nenormalno veliko število belih krvnih celic se lahko pojavi v krvi in drugih delih telesa.
English: Do not use this medicine after the expiry date which is stated on the carton and vial.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in viali.
English: Atriance has major influence on the ability to drive and use machines.
Slovenian: Atriance ima pomemben vpliv na sposobnost vožnje in upravljanja strojev.
English: The following convention has been utilised for the classification of frequency: 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), very rare (< 1/10,000), and not known (cannot be estimated from the available data).
Slovenian: Pogostnost je navedena v skladu z naslednjim dogovorom: 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), zelo redki (< 1/10.000) in neznana (ni mogoče oceniti iz razpoložljivih podatkov).
English: Supportive care consistent with good clinical practice should be provided.
Slovenian: Zagotoviti je treba podporno zdravljenje v skladu z dobro klinično prakso.
English: Some of the side effects were reported more often in adult patients.
Slovenian: O nekaterih neželenih učinkih so pogosteje poročali pri odraslih bolnikih.
English: This medicine contains at least 23 mg sodium per dose.
Slovenian: To zdravilo vsebuje najmanj 23 mg natrija na odmerek.
English: Clinical efficacy and data
Slovenian: Klinična učinkovitost in podatki
English: Nelarabine should not be used during pregnancy unless clearly necessary.
Slovenian: Nelarabina ne smete uporabljati med nosečnostjo, razen če je nujno potrebno.
English: • Lowered blood pressure.
Slovenian: • Znižanje krvnega tlaka.
English: This results in cell death.
Slovenian: To povzroči propad celice.
English: The potential risk in humans is unknown, however, exposure during pregnancy will likely lead to anomalies and malformations of the foetus.
Slovenian: Možno tveganje za ljudi ni znano, vendar pa bi izpostavljenost zdravilu med nosečnostjo verjetno povzročila anomalije in malformacije plodu.
English: Duration of response (in both classifications of response (n=5) ranged between 15 and 195+ weeks.
Slovenian: Odziv se je ohranil (po obeh definicijah odziva (n = 5)) od 15 do 195+ tednov.
English: • Unintentional rhythmic shaking of one or more limbs (tremors).
Slovenian: • Nehoteno ritmično tresenje enega ali več udov (tremor).
English: The majority of side effects reported with Atriance were seen in adults, children and adolescents.
Slovenian: Večina neželenih učinkov, o katerih so poročali pri uporabi zdravila Atriance, se je pojavila pri odraslih, otrocih in mladostnikih.
English: Men with partners who are pregnant or could become pregnant should use condoms during treatment with nelarabine and for at least three months following cessation of treatment.
Slovenian: Moški s partnerkami, ki so noseče ali lahko zanosijo, morajo med zdravljenjem z nelarabinom in še najmanj tri mesece po končanem zdravljenju uporabljati kondom.
English: Ask your doctor for advice before taking any medicine.
Slovenian: Posvetujte se s svojim zdravnikom, preden vzamete katerokoli zdravilo.
English: Tell your doctor if any of these apply to you.
Slovenian: Obvestite svojega zdravnika, če se karkoli od navedenega nanaša na vas.
English: Thirteen (42 %) of the 31 patients treated with one prior induction regimen achieved a complete response overall.
Slovenian: Pri trinajstih (42 %) od 31 bolnikov, ki so se predhodno zdravili z enim indukcijskim režimom zdravljenja, je bil dosežen popolni odziv v celoti.
English: This treatment may vary, depending on the results of regular blood tests.
Slovenian: Zdravljenje je lahko tudi drugačno, odvisno od izvidov rednih krvnih preiskav.
English: If you are an elderly person, you could be more sensitive to nervous system side effects (see the list above under “Warnings and precautions”).
Slovenian: Če ste starejša oseba, ste lahko bolj dovzetni za neželene učinke, ki so povezani z živčevjem (glejte zgoraj naštete simptome pod naslovom “Opozorila in previdnostni ukrepi”).
English: Atriance may reduce the number of white blood cells and lower your resistance to infection (including pneumonia).
Slovenian: Zdravilo Atriance lahko zmanjša število belih krvnih celic in zmanjša odpornost organizma proti okužbam (vključno s pljučnico).
English: Your dose of Atriance may need to be adjusted.
Slovenian: Odmerek zdravila Atriance bo morda treba prilagoditi.
English: This being an approval under exceptional circumstance and pursuant to Article 14(8) of Regulation (EC) No 726/2004, the MAH shall conduct, within the stated timeframe, the following measures:
Slovenian: DOVOLJENJA ZA PROMET Z ZDRAVILOM V IZJEMNIH OKOLIŠČINAH Ker gre za odobritev v izjemnih okoliščinah in ob upoštevanju člena 14(8) Uredbe (ES) št. 726/2004, mora imetnik dovoljenja za promet v določenem časovnem okviru izvesti naslednje ukrepe:
English: A blood test will be taken to check possible reduction of white blood cells.
Slovenian: Zdravnik bo s krvnimi preiskavami preveril morebitno zmanjšanje števila belih krvnih celic.
English: Nine of these 31 patients failed to respond to prior induction (refractory patients).
Slovenian: Devet od teh 31 bolnikov se na predhodno indukcijsko obliko zdravljenja ni odzvalo (neodzivni bolniki).
English: In an exploratory analysis, increasing age, especially age 65 years and older, appeared to be associated with increased rates of neurological adverse events.
Slovenian: Eksploratorna analiza kaže, da bi lahko bila višja starost, še posebej nad 65 let, povezana z večjim deležem nevroloških neželenih dogodkov.
English: • Swelling of parts of the body due to accumulation of abnormal amounts of fluid (oedema).
Slovenian: • Otekanje posameznih delov telesa zaradi nabiranja nenormalnih količin tekočine (edem).
English: • Violent, uncontrollable muscular contractions often accompanied by unconsciousness that can be due to an epileptic attack (seizures).
Slovenian: • Silovito in nenadzorovano krčenje mišic, ki ga pogosto spremlja nezavest in je lahko posledica epileptičnega napada (krči).
English: Talk to your doctor for advice on how to minimize the risk of bleeding.
Slovenian: Posvetujte se z zdravnikom, kako lahko zmanjšate tveganje za pojav krvavitev.
English: Both sexually active men and women should use effective methods of contraception during treatment with nelarabine.
Slovenian: Spolno aktivne ženske in moški morajo med zdravljenjem z nelarabinom uporabljati učinkovito metodo kontracepcije.
English: Male patients, who may wish to father a child, should ask their doctor for family planning advice or treatment.
Slovenian: Moški bolniki, ki želite postati očetje, se posvetujte s svojim zdravnikom o načrtovanju družine ali zdravljenju.
English: Rarely, it can lead to even more severe bleeding (haemorrhage).
Slovenian: V redkih primerih lahko pride tudi do hujših krvavitev (hemoragija).
English: Therefore, immunisations with live organism vaccines are not recommended.
Slovenian: Cepljenja z živimi cepivi zato ne priporočamo.
English: Adults (1,500 mg/m N=103
Slovenian: Odrasli (1.500 mg/m N=103
English: Nelarabine is excreted by the kidney to a small extent (5 to 10 % of the administered dose).
Slovenian: Nelarabin se skozi ledvice izloča v majhnem obsegu (5 do 10 % prejetega odmerka).
English: Atriance is supplied in packs of 1 vial or 6 vials.
Slovenian: Zdravilo Atriance je na voljo v pakiranjih po 1 vialo ali 6 vial.
English: Time to complete response in both classifications of response ranged from 2.9 to 11.7 weeks.
Slovenian: Po obeh definicijah odziva je bil popolni odziv dosežen po 2,9 do 11,7 tednih.
English: These patients should be treated with caution.
Slovenian: Pri zdravljenju takšnih bolnikov je potrebna previdnost.
English: • Clumsiness and lack of coordination affecting balance, walking, limb or eye movements, or speech.
Slovenian: • Okornost in pomanjkanje koordinacije, ki vpliva na ravnotežje, hojo, gibanje udov ali očesnih zrkel ali govor.
English: Based on the pharmacological action of the compound, undesirable effects on fertility are possible.
Slovenian: Na osnovi farmakološkega delovanja učinkovine so neželeni učinki na plodnost možni.
English: What Atriance is and what it is used for
Slovenian: Kaj je zdravilo Atriance in za kaj ga uporabljamo
English: • Unusual bruising or bleeding, caused by a decrease in the number of clotting cells in the blood.
Slovenian: • Neobičajne modrice ali krvavitve, ki so posledica zmanjšanja števila krvnih ploščic v krvi.
English: • Feeling generally weak and tired (temporary anaemia).
Slovenian: • Občutek splošne oslabelosti in utrujenosti (prehodna anemija).
English: Nelarabine is for intravenous use only and must not be diluted prior to administration.
Slovenian: Nelarabin je namenjen izključno za intravensko uporabo in ga pred uporabo ne smete razredčiti.
English: Your doctor should perform blood tests regularly during treatment to check for blood problems that have been associated with the use of Atriance.
Slovenian: Vaš zdravnik mora v času zdravljenja redno pregledovati vašo kri, da lahko spremlja pojavljanje težav s krvjo, ki so povezane z uporabo zdravila Atriance.
English: Atriance is used to treat patients with:
Slovenian: Zdravilo Atriance uporabljamo pri zdravljenju bolnikov z:
English: Nelarabine and ara-G did not significantly inhibit the activities of the major hepatic cytochrome P450 (CYP) isoenzymes CYP1A2, CYP2A6, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, or CYP3A4 in vitro.
Slovenian: Nelarabin in ara-G in vitro ne zavirata pomembneje aktivnosti glavnih jetrnih izoencimov citokroma P450 (CYP) CYP1A2, CYP2A6, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6 in CYP3A4.
English: • The active substance of Atriance is nelarabine.
Slovenian: • Učinkovina zdravila Atriance je nelarabin.
English: Very common: 10(12%)
Slovenian: Zelo pogosti: 10 (12 %)
English: This can lead to severe bleeding from relatively small injuries such as a small cut.
Slovenian: Obilna krvavitev se lahko pojavi že pri relativno blagi poškodbi, npr. manjši vreznini.
English: • if you (or your child, if he/she is being treated) are allergic to nelarabine or any of the other ingredients of this medicine (listed in section 6).
Slovenian: • če ste alergični na/je vaš otrok (če se on/ona zdravi) alergičen na nelarabin ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
English: This leaflet was last approved in
Slovenian: Navodilo je bilo nazadnje revidirano
English: What you need to know before you are given Atriance
Slovenian: Kaj morate vedeti, preden boste prejeli zdravilo Atriance
English: Nelarabine and ara-G are partially eliminated by the kidneys.
Slovenian: Nelarabin in ara-G se deloma izločata skozi ledvice.
English: Nelarabine and 9-β-Darabinofuranosylguanine (ara-G) are partially renally excreted (see section 5.2).
Slovenian: Nelarabin in 9-β-Darabinofuranozilgvanin (ara-G) se deloma izločata skozi ledvice (glejte poglavje 5.2).
English: Pharmacotherapeutic group: Antineoplastic agents, antimetabolites, purine analogues, ATC code: L01B B 07
Slovenian: Farmakoterapevtska skupina: Zdravila z delovanjem na novotvorbe (citostatiki), zaviralci celične presnove (antimetaboliti), analogi purinskih baz, oznaka ATC: L01B B 07
English: Ara-G is excreted by the kidney to a greater extent (20 to 30 % of the administered nelarabine dose).
Slovenian: Ara-G pa se skozi ledvice izloča v večjem obsegu (20 do 30 % prejetega odmerka nelarabina).
English: Children (650 mg/m N=84
Slovenian: Otroci (650 mg/m N=84
English: Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Slovenian: Obvestite svojega zdravnika ali farmacevta, če jemljete, ste pred kratkim jemali, ali pa boste morda začeli uporabljati katerokoli zdravilo, vključno z vsemi zdravili rastlinskega izvora in zdravili, ki ste jih dobili brez recepta.
English: • Serious disease that destroys skeletal muscle characterized by the presence of myoglobin (a breakdown product of muscle cells) in the urine (Rhabdomyolysis), increase in blood creatine phosphokinase.
Slovenian: • Resna bolezen, ki uniči skeletne mišice in se kaže s prisotnostjo mioglobina (razgradni produkt mišičnih celic) v urinu (rabdomioliza), povišana koncentracija kreatin fosfokinaze v krvi.
English: Peripheral neurological disorders (sensory and motor)
Slovenian: somnolenca motnje perifernega živčevja (senzoričnega in motoričnega)
English: You will have an infusion (a drip) once a day on days 1, 3 and 5 of treatment.
Slovenian: Kapljično infuzijo boste prejeli na 1., 3. in 5. dan zdravljenja enkrat na dan.
English: Other mechanisms may contribute to the cytotoxic effects of nelarabine.
Slovenian: Drugi mehanizmi lahko prispevajo k citotoksičnim učinkom nelarabina.
English: The apparent clearance of ara-G (Cl/F) is comparable between the two groups [9.5 l/h/m
Slovenian: Na 1. dan je navidezni očistek ara-G (Cl/F) primerljiv med obema starostnima skupinama (9,5 l/h/m
English: 5 every 21 days, 2 patients developed a significant grade 3 ascending sensory neuropathy.
Slovenian: 21 dni se je pri 2 bolnikih pojavila pomembna ascendentna senzorična nevropatija stopnje 3.
English: Your doctor will check for these symptoms regularly during treatment.
Slovenian: Zdravnik vas bo v času zdravljenja redno pregledoval glede teh simptomov.
English: This is to be taken into consideration if you are on a controlled sodium diet.
Slovenian: To morate upoštevati, če ste na dieti z nadzorovanim vnosom natrija.
English: • your/your child's (if he/she is being treated) body surface area (which will be calculated by your doctor based on your height and weight).
Slovenian: • vaše telesne površine/telesne površine vašega otroka (če se zdravi on/ona) (zdravnik jo bo izračunal na osnovi podatkov o telesni višini in telesni masi).
English: • Increases in blood creatinine levels (a sign of kidney problems, which might lead less frequent urination).
Slovenian: • Zvišanje koncentracije kreatinina v krvi (znak ledvičnih težav, katerih posledica je lahko manjša pogostost uriniranja).
English: It is unknown whether nelarabine or its metabolites are excreted in human breast milk.
Slovenian: Ni znano, če se nelarabin ali njegovi presnovki izločajo v materino mleko.
English: (35 %) in adult patients and 10.8 l/h/m
Slovenian: (35 %) pri odraslih bolnikih in 10,8 l/h/m
English: Intracellular Cmax for ara-GTP appeared within 3 to 25 hours on day 1.
Slovenian: Znotrajcelične Cmax koncentracije ara-GTP so bile dosežene v 3 do 25 urah na 1. dan.
English: The mean apparent clearance (Cl/F) of ara-G was about 7 % lower in patients with mild renal impairment than in patients with normal renal function (see section 4.2).
Slovenian: Pri bolnikih z blago ledvično okvaro je bil navidezni srednji očistek (Cl/F) ara-G za približno 7 % manjši kot pri bolnikih z normalnim delovanjem ledvic (glejte poglavje 4.2).
English: Any liquid waste from the preparation of the nelarabine solution for infusion may be flushed with large amounts of water.
Slovenian: Odpadno tekočino pri pripravi nelarabin raztopine za infundiranje lahko sperete z velikimi količinami vode.