natgillin/translations-raw huggingface dataset:
Each film-coated tablet of Irbesartan Hydrochlorothiazide Zentiva 300 mg/12.5 mg contains 300 mg irbesartan and 12.5 mg hydrochlorothiazide.
Ena Irbesartan Hydrochlorothiazide Zentiva 300 mg/12,5 mg filmsko obložena tableta vsebuje 300 mg irbesartana in 12,5 mg hidroklorotiazida.
Each tablet of Irbesartan Hydrochlorothiazide Zentiva 150 mg/12.5 mg contains 150 mg irbesartan and 12.5 mg hydrochlorothiazide.
Zentiva 150 mg/12,5 mg tableta vsebuje 150 mg irbesartana in 12,5 mg hidroklorotiazida.
Uncommon cases of jaundice (yellowing of the skin and/or whites of the eyes) have also been reported.
(rumeno obarvanje kože in/ali očesnih beločnic), ki se je pojavila občasno.
EU/1/06/377/001 - 14 tablets EU/1/06/377/002 - 28 tablets EU/1/06/377/003 - 56 tablets EU/1/06/377/004 - 56 x 1 tablets EU/1/06/377/005 - 98 tablets
EU/1/06/377/004 - 56 x 1 tableta EU/1/06/377/005 - 98 tablet
Once daily dosing with 150 mg irbesartan and 12.5 mg hydrochlorothiazide gave systolic/diastolic mean placebo-adjusted blood pressure reductions at trough (24 hours post-dosing) of 12.9/6.9 mm Hg in patients with mild-to-moderate hypertension.
12,5 mg hidroklorotizida, se je 24 ur po zaužitju odmerka sistolični krvni tlak znižal za 12,9 mmHg bolj kot po uporabi placeba, diastolični pa za 6,9 mmHg.
No dosage adjustment of Irbesartan Hydrochlorothiazide Zentiva is necessary inolder people.
Pri starostnikih odmerka zdravila Irbesartan Hydrochlorothiazide Zentiva ni treba prilagajati.
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.
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.
NAME OF THE MEDICINAL PRODUCT Irbesartan Hydrochlorothiazide Zentiva 300 mg/25 mg film-coated tablets.
Irbesartan Hydrochlorothiazide Zentiva 300 mg/25 mg filmsko obložene tablete
Irbesartan Hydrochlorothiazide Zentiva 300 mg/25 mg film-coated tablets irbesartan/hydrochlorothiazide
Irbesartan Hydrochlorothiazide Zentiva 300 mg/25 mg filmsko obložene tablete irbesartan/hidroklorotiazid
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.
Nasprotno pa se lahko zaradi irbesartana, ki ga vsebuje zdravilo Irbesartan Hydrochlorothiazide Zentiva, pojavi hiperkaliemija,
While this is not documented with Irbesartan Hydrochlorothiazide Zentiva, a similar effect should be anticipated.
Podoben učinek bi lahko pričakovali pri zdravljenju z zdravilom Irbesartan Hydrochlorothiazide Zentiva, čeprav to pri zdravljenju z njim ni bilo dokazano.
Each tablet of Irbesartan Hydrochlorothiazide Zentiva 300 mg/12.5 mg contains 300 mg irbesartan and 12.5 mg hydrochlorothiazide.
Zentiva 300 mg/12,5 mg tableta vsebuje 300 mg irbesartana in 12,5 mg hidroklorotiazida.
What Irbesartan Hydrochlorothiazide Zentiva contains The active substances are irbesartan and hydrochlorothiazide.
Zdravilni učinkovini sta irbesartan in hidroklorotiazid.
• 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;
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.
Irbesartan Hydrochlorothiazide Zentiva 150 mg/12.5 mg film-coated tablets irbesartan/hydrochlorothiazide
Irbesartan Hydrochlorothiazide Zentiva 150 mg/12,5 mg filmsko obložene tablete irbesartan/hidroklorotiazid
Package leaflet: Information for the patient Irbesartan Hydrochlorothiazide Zentiva 300 mg/25 mg film-coated tablets irbesartan/hydrochlorothiazide
Navodilo za uporabo Irbesartan Hydrochlorothiazide Zentiva 300 mg/25 mg filmsko obložene tablete irbesartan/hidroklorotiazid
Irbesartan Hydrochlorothiazide Zentiva 300 mg/12.5 mg film-coated tablets irbesartan/hydrochlorothiazide
Irbesartan Hydrochlorothiazide Zentiva 300 mg/12,5 mg filmsko obložene tablete irbesartan/hidroklorotiazid
Although not specifically studied with the Irbesartan Hydrochlorothiazide Zentiva, rebound hypertension has not been seen with either irbesartan or hydrochlorothiazide.
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.
• Irbesartan Hydrochlorothiazide Zentiva 300 mg/12.5 mg may be administered in patients insufficiently controlled by irbesartan 300 mg or by Irbesartan Hydrochlorothiazide
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.
NAME OF THE MEDICINAL PRODUCT Irbesartan Hydrochlorothiazide Zentiva 150 mg/12.5 mg film-coated tablets.
Irbesartan Hydrochlorothiazide Zentiva 150 mg/12,5 mg filmsko obložene tablete
Irbesartan Hydrochlorothiazide Zentiva is for oral use.
Irbesartan Hydrochlorothiazide Zentiva ni priporočljivo.
NAME OF THE MEDICINAL PRODUCT Irbesartan Hydrochlorothiazide Zentiva 300 mg/12.5 mg film-coated tablets.
Irbesartan Hydrochlorothiazide Zentiva 300 mg/12,5 mg filmsko obložene tablete
• 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.
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.
While hydrochlorothiazide is a sulfonamide, only isolated cases of acute angleclosure glaucoma have been reported so far with hydrochlorothiazide.
vendar pa so do sedaj med njegovo uporabo poročali le o posameznih primerih akutnega glavkoma z zaprtim zakotjem.
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
EU/1/06/377/020 - 56 x 1 tableta EU/1/06/377/021 - 84 tablet
QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 150 mg of irbesartan and 12.5 mg of hydrochlorothiazide.
Ena filmsko obložena tableta vsebuje 150 mg irbesartana in 12,5 mg hidroklorotiazida.
Package leaflet: Information for the patient Irbesartan Hydrochlorothiazide Zentiva 300 mg/12.5 mg tablets irbesartan/hydrochlorothiazide
Navodilo za uporabo Irbesartan Hydrochlorothiazide Zentiva 300 mg/12,5 mg tablete irbesartan/hidroklorotiazid
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
EU/1/06/377/026 - 56 x 1 tableta EU/1/06/377/027 - 84 tablet
Package leaflet: Information for the patient Irbesartan Hydrochlorothiazide Zentiva 150 mg/12.5 mg tablets irbesartan/hydrochlorothiazide
Navodilo za uporabo Irbesartan Hydrochlorothiazide Zentiva 150 mg/12,5 mg tablete irbesartan/hidroklorotiazid
QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 300 mg of irbesartan and 12.5 mg of hydrochlorothiazide.
Ena filmsko obložena tableta vsebuje 300 mg irbesartana in 12,5 mg hidroklorotiazida.
120 (60 x 2) capsules (multipack)
120 (60 x 2) kapsul (večkratno pakiranje)
Efficacy and safety were similar for both regimens.
Učinkovitost in varnost obeh režimov zdravljenja sta bili podobni.
A risk to the newborn/infant cannot be excluded.
Tveganja za novorojenčka/dojenčka ni mogoče izključiti.
There is no known reason for this.
Razlog za to ni znan.
Date of first authorisation: 22 August 2007 Date of latest renewal: 16 June 2017
Datum prve odobritve: 22. avgust 2007 Datum zadnjega podaljšanja: 16. junij 2017
In some cases you may need a blood transfusion.
V nekaterih primerih bo morda potrebna transfuzija krvi.
This pattern of treatment will normally be repeated every three weeks.
Takšen vzorec zdravljenja se običajno ponavlja vsake tri tedne.
• Signs of infection.
• Znaki okužbe.
If you feel tired or weak, do not drive, and do not use any tools or machines.
Če ste utrujeni ali slabotni, ne vozite vozil in ne upravljajte s stroji ali z orodji.
Your doctor will decide how many treatment cycles are required.
Vaš zdravnik bo odločil, koliko ciklusov zdravljenja potrebujete.
4866 Unterach am Attersee Austria
4866 Unterach am Attersee Avstrija
This includes spontaneous case reports as well as serious adverse events from ongoing studies.
Ta poročila vključujejo tako spontana poročila kot tudi resne neželene učinke iz študij, ki potekajo.
The following additional adverse reactions were seen:
Opaženi so bili naslednji dodatni neželeni učinki:
Blood tests during treatment
Krvne preiskave v času zdravljenja
The abnormal high number of white blood cells can appear in the blood and other parts of the body.
Nenormalno veliko število belih krvnih celic se lahko pojavi v krvi in drugih delih telesa.
Do not use this medicine after the expiry date which is stated on the carton and vial.
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in viali.
Atriance has major influence on the ability to drive and use machines.
Atriance ima pomemben vpliv na sposobnost vožnje in upravljanja strojev.
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).
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).
Supportive care consistent with good clinical practice should be provided.
Zagotoviti je treba podporno zdravljenje v skladu z dobro klinično prakso.
Some of the side effects were reported more often in adult patients.
O nekaterih neželenih učinkih so pogosteje poročali pri odraslih bolnikih.
This medicine contains at least 23 mg sodium per dose.
To zdravilo vsebuje najmanj 23 mg natrija na odmerek.
Clinical efficacy and data
Klinična učinkovitost in podatki
Nelarabine should not be used during pregnancy unless clearly necessary.
Nelarabina ne smete uporabljati med nosečnostjo, razen če je nujno potrebno.
• Lowered blood pressure.
• Znižanje krvnega tlaka.
This results in cell death.
To povzroči propad celice.
The potential risk in humans is unknown, however, exposure during pregnancy will likely lead to anomalies and malformations of the foetus.
Možno tveganje za ljudi ni znano, vendar pa bi izpostavljenost zdravilu med nosečnostjo verjetno povzročila anomalije in malformacije plodu.
Duration of response (in both classifications of response (n=5) ranged between 15 and 195+ weeks.
Odziv se je ohranil (po obeh definicijah odziva (n = 5)) od 15 do 195+ tednov.
• Unintentional rhythmic shaking of one or more limbs (tremors).
• Nehoteno ritmično tresenje enega ali več udov (tremor).
The majority of side effects reported with Atriance were seen in adults, children and adolescents.
Večina neželenih učinkov, o katerih so poročali pri uporabi zdravila Atriance, se je pojavila pri odraslih, otrocih in mladostnikih.
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.
Moški s partnerkami, ki so noseče ali lahko zanosijo, morajo med zdravljenjem z nelarabinom in še najmanj tri mesece po končanem zdravljenju uporabljati kondom.
Ask your doctor for advice before taking any medicine.
Posvetujte se s svojim zdravnikom, preden vzamete katerokoli zdravilo.
Tell your doctor if any of these apply to you.
Obvestite svojega zdravnika, če se karkoli od navedenega nanaša na vas.
Thirteen (42 %) of the 31 patients treated with one prior induction regimen achieved a complete response overall.
Pri trinajstih (42 %) od 31 bolnikov, ki so se predhodno zdravili z enim indukcijskim režimom zdravljenja, je bil dosežen popolni odziv v celoti.
This treatment may vary, depending on the results of regular blood tests.
Zdravljenje je lahko tudi drugačno, odvisno od izvidov rednih krvnih preiskav.
If you are an elderly person, you could be more sensitive to nervous system side effects (see the list above under “Warnings and precautions”).
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”).
Atriance may reduce the number of white blood cells and lower your resistance to infection (including pneumonia).
Zdravilo Atriance lahko zmanjša število belih krvnih celic in zmanjša odpornost organizma proti okužbam (vključno s pljučnico).
Your dose of Atriance may need to be adjusted.
Odmerek zdravila Atriance bo morda treba prilagoditi.
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:
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:
A blood test will be taken to check possible reduction of white blood cells.
Zdravnik bo s krvnimi preiskavami preveril morebitno zmanjšanje števila belih krvnih celic.
Nine of these 31 patients failed to respond to prior induction (refractory patients).
Devet od teh 31 bolnikov se na predhodno indukcijsko obliko zdravljenja ni odzvalo (neodzivni bolniki).
In an exploratory analysis, increasing age, especially age 65 years and older, appeared to be associated with increased rates of neurological adverse events.
Eksploratorna analiza kaže, da bi lahko bila višja starost, še posebej nad 65 let, povezana z večjim deležem nevroloških neželenih dogodkov.
• Swelling of parts of the body due to accumulation of abnormal amounts of fluid (oedema).
• Otekanje posameznih delov telesa zaradi nabiranja nenormalnih količin tekočine (edem).
• Violent, uncontrollable muscular contractions often accompanied by unconsciousness that can be due to an epileptic attack (seizures).
• Silovito in nenadzorovano krčenje mišic, ki ga pogosto spremlja nezavest in je lahko posledica epileptičnega napada (krči).
Talk to your doctor for advice on how to minimize the risk of bleeding.
Posvetujte se z zdravnikom, kako lahko zmanjšate tveganje za pojav krvavitev.
Both sexually active men and women should use effective methods of contraception during treatment with nelarabine.
Spolno aktivne ženske in moški morajo med zdravljenjem z nelarabinom uporabljati učinkovito metodo kontracepcije.
Male patients, who may wish to father a child, should ask their doctor for family planning advice or treatment.
Moški bolniki, ki želite postati očetje, se posvetujte s svojim zdravnikom o načrtovanju družine ali zdravljenju.
Rarely, it can lead to even more severe bleeding (haemorrhage).
V redkih primerih lahko pride tudi do hujših krvavitev (hemoragija).
Therefore, immunisations with live organism vaccines are not recommended.
Cepljenja z živimi cepivi zato ne priporočamo.
Adults (1,500 mg/m N=103
Odrasli (1.500 mg/m N=103
Nelarabine is excreted by the kidney to a small extent (5 to 10 % of the administered dose).
Nelarabin se skozi ledvice izloča v majhnem obsegu (5 do 10 % prejetega odmerka).
Atriance is supplied in packs of 1 vial or 6 vials.
Zdravilo Atriance je na voljo v pakiranjih po 1 vialo ali 6 vial.
Time to complete response in both classifications of response ranged from 2.9 to 11.7 weeks.
Po obeh definicijah odziva je bil popolni odziv dosežen po 2,9 do 11,7 tednih.
These patients should be treated with caution.
Pri zdravljenju takšnih bolnikov je potrebna previdnost.
• Clumsiness and lack of coordination affecting balance, walking, limb or eye movements, or speech.
• Okornost in pomanjkanje koordinacije, ki vpliva na ravnotežje, hojo, gibanje udov ali očesnih zrkel ali govor.
Based on the pharmacological action of the compound, undesirable effects on fertility are possible.
Na osnovi farmakološkega delovanja učinkovine so neželeni učinki na plodnost možni.
What Atriance is and what it is used for
Kaj je zdravilo Atriance in za kaj ga uporabljamo
• Unusual bruising or bleeding, caused by a decrease in the number of clotting cells in the blood.
• Neobičajne modrice ali krvavitve, ki so posledica zmanjšanja števila krvnih ploščic v krvi.
• Feeling generally weak and tired (temporary anaemia).
• Občutek splošne oslabelosti in utrujenosti (prehodna anemija).
Nelarabine is for intravenous use only and must not be diluted prior to administration.
Nelarabin je namenjen izključno za intravensko uporabo in ga pred uporabo ne smete razredčiti.
Your doctor should perform blood tests regularly during treatment to check for blood problems that have been associated with the use of Atriance.
Vaš zdravnik mora v času zdravljenja redno pregledovati vašo kri, da lahko spremlja pojavljanje težav s krvjo, ki so povezane z uporabo zdravila Atriance.
Atriance is used to treat patients with:
Zdravilo Atriance uporabljamo pri zdravljenju bolnikov z:
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.
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.
• The active substance of Atriance is nelarabine.
• Učinkovina zdravila Atriance je nelarabin.
Very common: 10(12%)
Zelo pogosti: 10 (12 %)
This can lead to severe bleeding from relatively small injuries such as a small cut.
Obilna krvavitev se lahko pojavi že pri relativno blagi poškodbi, npr. manjši vreznini.
• 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).
• 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).
This leaflet was last approved in
Navodilo je bilo nazadnje revidirano
What you need to know before you are given Atriance
Kaj morate vedeti, preden boste prejeli zdravilo Atriance
Nelarabine and ara-G are partially eliminated by the kidneys.
Nelarabin in ara-G se deloma izločata skozi ledvice.
Nelarabine and 9-β-Darabinofuranosylguanine (ara-G) are partially renally excreted (see section 5.2).
Nelarabin in 9-β-Darabinofuranozilgvanin (ara-G) se deloma izločata skozi ledvice (glejte poglavje 5.2).
Pharmacotherapeutic group: Antineoplastic agents, antimetabolites, purine analogues, ATC code: L01B B 07
Farmakoterapevtska skupina: Zdravila z delovanjem na novotvorbe (citostatiki), zaviralci celične presnove (antimetaboliti), analogi purinskih baz, oznaka ATC: L01B B 07
Ara-G is excreted by the kidney to a greater extent (20 to 30 % of the administered nelarabine dose).
Ara-G pa se skozi ledvice izloča v večjem obsegu (20 do 30 % prejetega odmerka nelarabina).
Children (650 mg/m N=84
Otroci (650 mg/m N=84
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
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.
• 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.
• 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.
Peripheral neurological disorders (sensory and motor)
somnolenca motnje perifernega živčevja (senzoričnega in motoričnega)
You will have an infusion (a drip) once a day on days 1, 3 and 5 of treatment.
Kapljično infuzijo boste prejeli na 1., 3. in 5. dan zdravljenja enkrat na dan.
Other mechanisms may contribute to the cytotoxic effects of nelarabine.
Drugi mehanizmi lahko prispevajo k citotoksičnim učinkom nelarabina.
The apparent clearance of ara-G (Cl/F) is comparable between the two groups [9.5 l/h/m
Na 1. dan je navidezni očistek ara-G (Cl/F) primerljiv med obema starostnima skupinama (9,5 l/h/m
5 every 21 days, 2 patients developed a significant grade 3 ascending sensory neuropathy.
21 dni se je pri 2 bolnikih pojavila pomembna ascendentna senzorična nevropatija stopnje 3.
Your doctor will check for these symptoms regularly during treatment.
Zdravnik vas bo v času zdravljenja redno pregledoval glede teh simptomov.
This is to be taken into consideration if you are on a controlled sodium diet.
To morate upoštevati, če ste na dieti z nadzorovanim vnosom natrija.
• 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).
• 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).
• Increases in blood creatinine levels (a sign of kidney problems, which might lead less frequent urination).
• Zvišanje koncentracije kreatinina v krvi (znak ledvičnih težav, katerih posledica je lahko manjša pogostost uriniranja).
It is unknown whether nelarabine or its metabolites are excreted in human breast milk.
Ni znano, če se nelarabin ali njegovi presnovki izločajo v materino mleko.
(35 %) in adult patients and 10.8 l/h/m
(35 %) pri odraslih bolnikih in 10,8 l/h/m
Intracellular Cmax for ara-GTP appeared within 3 to 25 hours on day 1.
Znotrajcelične Cmax koncentracije ara-GTP so bile dosežene v 3 do 25 urah na 1. dan.
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).
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).
Any liquid waste from the preparation of the nelarabine solution for infusion may be flushed with large amounts of water.
Odpadno tekočino pri pripravi nelarabin raztopine za infundiranje lahko sperete z velikimi količinami vode.
Atriance contains nelarabine which belongs to a group of medicines known as antineoplastic agents, used in chemotherapy to kill some types of cancer cells.
Zdravilo Atriance vsebuje nelarabin, ki spada v skupino zdravil, ki jih imenujemo antineoplastična zdravila in jih uporabljamo v kemoterapiji za uničenje nekaterih vrst rakavih celic.
Accumulation of ara-GTP in leukaemic blasts allows for preferential incorporation of ara-GTP into deoxyribonucleic acid (DNA) leading to inhibition of DNA synthesis.
Kopičenje ara-GTP v levkemičnih blastnih celicah omogoča želeno vgraditev ara-GTP v deoksiribonukleinsko kislino (DNA), kar vodi v zavrtje sinteze DNA.
(214 %) in adult and paediatric patients, respectively, on day 1 (n = 65 adults, n = 21 paediatric patients).
(214 %) (n = 65 odrasli bolniki, n = 21 otroci).
For patients at risk of hyperuricaemia, the use of allopurinol should be considered.
Pri bolnikih s tveganjem za pojav hiperurikemije je treba razmisliti o uporabi alopurinola.