FrancophonIA/ELRC3.0 huggingface dataset:
English: Deutschland Teva GmbH Tel: +49 73140208
Slovenian: Tél/Tel: +49 73140202
English: If they occur, the dose of levodopa should be decreased.
Slovenian: Bolnikom s takšnimi diskinezijami zmanjšamo odmerek levodope.
English: 2 tablets Pramipexole Teva 0.088 mg three times a day
Slovenian: 2 tableti zdravila Pramipeksol Teva po 0,088 mg 3-krat na dan
English: Pramipexole Teva 0.18 mg tablets
Slovenian: Pramipeksol Teva 0,18 mg tablete
English: High brain tissue concentrations were observed in the rat (approx. 8-fold compared to plasma).
Slovenian: (približno 8-kratno v primerjavi s plazmo).
English: Renal excretion of unchanged pramipexole is the major route of elimination.
Slovenian: Pramipeksol se izloči v glavnem nespremenjen skozi ledvice.
English: Other medicines and Pramipexole Teva
Slovenian: Shranjevanje zdravila Pramipeksol Teva
English: Uncommon may affect up to 1 in 100 people
Slovenian: pojavijo se lahko pri največ 1 od 100 bolnikov
English: If use of Pramipexole Teva is unavoidable, breast-feeding should be stopped.
Slovenian: Če se jemanju ne morete izogniti, morate prenehati dojiti.
English: You should have regular eye examinations during treatment with Pramipexole Teva.
Slovenian: • Motnje vida: Med zdravljenjem z zdravilom Pramipeksol Teva morate redno hoditi na preglede oči.
English: The overall incidence of hallucinations and somnolence was generally higher in the escalation phase with the pramipexole group.
Slovenian: Skupna pojavnost halucinacij in somnolence je bila med titriranjem na splošno večja ob pramipeksolu, medtem ko med vzdrževalnim zdravljenjem ni bilo signifikantne razlike.
English: The active substance is pramipexole.
Slovenian: Aktivnost pramipeksola je v celoti intrinzična.
English: • After stopping or reducing your Pramipexole Teva treatment: Depression, apathy, anxiety,
Slovenian: • Po prenehanju zdravljenja z zdravilom Pramipeksol Teva ali zmanjšanju odmerka: pojavijo se lahko depresija, apatija, anksioznost, utrujenost, znojenje ali bolečina (to se imenuje sindrom odtegnitve dopaminskega agonista).
English: • Dyskinesia (e.g. abnormal, uncontrolled movements of the limbs).
Slovenian: • diskinezija (npr. nenormalni, nenadzorovani gibi udov),
English: For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
Slovenian: Za vse morebitne nadaljnje informacije o tem zdravilu se lahko obrnete na predstavništvo imetnika dovoljenja za promet z zdravilom: België/Belgique/Belgien
English: 1 tablet Pramipexole Teva 0.088 mg three times a day
Slovenian: 1 tableta zdravila Pramipeksol Teva po 0,088 mg 3-krat na dan
English: Pramipexole Teva 0.7 mg tablets
Slovenian: Pramipeksol Teva 0,7 mg tablete
English: Pramipexole Teva 0.7 mg tablets EU/1/08/490/013
Slovenian: Pramipeksol Teva 0,7 mg tablete EU/1/08/490/013
English: 2 tablets Pramipexole Teva 0.18 mg
Slovenian: 2 tableti zdravila Pramipeksol Teva po 0,18 mg
English: Pramipexole Teva with food, drink and alcohol You should be cautious while drinking alcohol during treatment with Pramipexole Teva.
Slovenian: Če med zdravljenjem z zdravilom Pramipeksol Teva pijete alkohol, morate biti previdni.
English: Talk to your doctor before taking Pramipexole Teva.
Slovenian: Pred začetkom jemanja zdravila Pramipeksol Teva se posvetujte s svojim zdravnikom.
English: Pramipexole Teva 0.35 mg tablets EU/1/08/490/009
Slovenian: Pramipeksol Teva 0,35 mg tablete EU/1/08/490/009
English: Non-motor adverse effects may occur when tapering or discontinuing dopamine agonists including pramipexole.
Slovenian: Pri postopnem zmanjševanju ali prekinitvi odmerjanja dopaminskih agonistov, vključno s pramipeksolom, se lahko pojavijo nemotorični neželeni učinki.
English: Nervous system disorders headache dizziness somnolence sudden onset of sleep syncope dyskinesia amnesia1 hyperkinesia1
Slovenian: Bolezni živčevja glavobol omotičnost zaspanost nenaden nepremagljiv spanec sinkopa diskinezija amnezija1 hiperkinezija1
English: • If you get any of the side effects, talk to your doctor or pharmacist.
Slovenian: Če opazite katerega koli izmed neželenih učinkov, se posvetujte z zdravnikom ali farmacevtom.
English: Pramipexole doses as published in the literature refer to the salt form.
Slovenian: Odmerki pramipeksola, objavljeni v literaturi, se nanašajo na sol. Odmerki so zato tu navedeni za obe obliki, pramipeksol in pramipeksolijevo sol (v oklepaju).
English: The individual dose of pramipexole should be in the range of 0.264 mg of base (0.375 mg of salt) to a maximum of 3.3 mg of base (4.5 mg of salt) per day.
Slovenian: (0,375 mg soli) do največ 3,3 mg pramipeksola (4,5 mg soli) na dan.
English: Dyskinesia
Slovenian: Odmerjanje
English: When prescribing Pramipexole Teva in a patient with Parkinson's disease with renal impairment a reduced dose is suggested in line with section 4.2.
Slovenian: Preobčutljivost na učinkovino ali katero koli pomožno snov, navedeno v poglavju 6.1. 4.4 Posebna opozorila in previdnostni ukrepi Ko predpisujemo zdravilo Pramipeksol Teva bolnikom s Parkinsonovo boleznijo in ledvičnim popuščanjem, je priporočljivo, da zmanjšamo odmerek po navodilih iz poglavja 4.2.
English: 1 tablet Pramipexole Teva 0.18 mg three times a day OR
Slovenian: 1 tableta zdravila Pramipeksol Teva po 0,18 mg 3-krat na dan ALI
English: 1 tablet Pramipexole Teva 0.18 mg
Slovenian: 1 tableta zdravila Pramipeksol Teva po 0,18 mg
English: • Constipation
Slovenian: • utrujenost
English: Pramipexole Teva 0.088 mg tablets EU/1/08/490/001
Slovenian: Pramipeksol Teva 0,088 mg tablete EU/1/08/490/001
English: Pack sizes: 30, 30 x 1, 50 x 1, 100 x 1 and 100 tablets Polyethylene tablet container with CRC polypropylene cap.
Slovenian: Velikosti pakiranj: 30, 30 x 1, 50 x 1, 100 x 1 in 100 tablet.
English: Colloidal silicon dioxide.
Slovenian: Aluminijasto aluminijasti pretisni omoti.
English: Hrvatska
Slovenian: Distonija
English: Each tablet contains 0.5 mg pramipexole dihydrochloride monohydrate equivalent to 0.35 mg pramipexole.
Slovenian: Ena tableta vsebuje 0,5 mg pramipeksolijevega diklorida monohidrata, kar ustreza 0,35 mg pramipeksola.
English: Pramipexole Teva 0.18 mg tablets EU/1/08/490/005
Slovenian: Pramipeksol Teva 0,18 mg tablete EU/1/08/490/005
English: Microcrystalline cellulose Sodium starch glycolate Povidone K25
Slovenian: FARMACEVTSKI PODATKI 6.1 Seznam pomožnih snovi manitol mikrokristalna celuloza natrijev karboksimetilškrob povidon magnezijev stearat natrijev stearilfumarat koloidni silicijev dioksid
English: Restless Legs Syndrome
Slovenian: Sindrom nemirnih nog
English: 2 tablets Pramipexole Teva 0.088 mg
Slovenian: 2 tableti zdravila Pramipeksol Teva po 0,088 mg
English: Please note:
Slovenian: (na primer:
English: • This medicine has been prescribed for you only.
Slovenian: Zdravilo je bilo predpisano vam osebno in ga ne smete dajati drugim.
English: 4 tablets Pramipexole Teva 0.088 mg
Slovenian: 4 tablete zdravila Pramipeksol Teva po 0,088 mg
English: • Restlessness
Slovenian: • omedlevica
English: Uncommon:
Slovenian: Neznana pogostnost:
English: Each tablet contains 0.125 mg pramipexole dihydrochloride monohydrate equivalent to 0.088 mg pramipexole.
Slovenian: Ena tableta vsebuje 0,125 mg pramipeksolijevega diklorida monohidrata, kar ustreza 0,088 mg pramipeksola..
English: • Sleepiness
Slovenian: • zaspanost
English: (eating more food than normal and more than is needed to satisfy your hunger)*
Slovenian: • prenajedanje (uživanje velikih količin hrane v kratkem obdobju) ali kompulzivno uživanje hrane (uživanje večjih količin hrane od normalnih in več, kot je potrebno za potešitev lakote)*, • manija (agitacija, vznesenost ali prevelika vznemirjenost)*,
English: 6 tablets Pramipexole Teva 0.088 mg
Slovenian: 6 tablet zdravila Pramipeksol Teva po 0,088 mg
English: Each tablet contains 0.25 mg pramipexole dihydrochloride monohydrate equivalent to 0.18 mg pramipexole.
Slovenian: Ena tableta vsebuje 0,25 mg pramipeksolijevega diklorida monohidrata, kar ustreza 0,18 mg pramipeksola.
English: In advanced Parkinson's disease, pramipexole doses higher than 1.1 mg of base (1.5 mg of salt) per day can be useful in patients where a reduction of the levodopa therapy is intended.
Slovenian: Med povečevanjem odmerka v ključnih študijah so učinek zasledili ob odmerku 1,1 mg pramipeksola (1,5 mg soli) na dan. Odmerek nadalje prilagajamo glede na klinični odziv in pojavljanje neželenih učinkov.
English: • Fainting
Slovenian: • nemir
English: Reduction of the pramipexole dose should be considered when these medicinal products are administered concomitantly with Pramipexole Teva.
Slovenian: Če zdravilo Pramipeksol Teva predpisujemo sočasno s tovrstnimi zdravili, razmislimo o zmanjšanju odmerka pramipeksola.
English: Each tablet contains 1 mg pramipexole dihydrochloride monohydrate equivalent to 0.7 mg pramipexole.
Slovenian: Ena tableta vsebuje 1 mg pramipeksolijevega diklorida monohidrata, kar ustreza 0,7 mg pramipeksola.
English: Each tablet 0.125 mg pramipexole dihydrochloride monohydrate equivalent to 0.088 mg pramipexole.
Slovenian: Ena tableta vsebuje 0,125 mg pramipeksolijevega diklorida monohidrata, kar ustreza 0,088 mg pramipeksola.
English: 6.5 Nature and contents of container Aluminium/Aluminium Blister
Slovenian: 6.5 Vrsta ovojnine in vsebina
English: for example, an increased sexual drive.
Slovenian: npr. kadar je pričakovan antagonistični učinek.
English: 1 tablet Pramipexole Teva 0.088 mg
Slovenian: 1 tableta zdravila Pramipeksol Teva po 0,088 mg
English: 3 tablets Pramipexole Teva 0.18 mg
Slovenian: 3 tablete zdravila Pramipeksol Teva po 0,18 mg ALI
English: Once Daily Evening Dose (mg of salt)
Slovenian: Teden Odmerek (mg)
English: Táncsics Mihály út 82 Hungary
Slovenian: Teva Pharmaceutical Works Private Limited Company Táncsics Mihály út 82
English: Each tablet contains 1.0 mg pramipexole dihydrochloride monohydrate equivalent to 0.7 mg pramipexole.
Slovenian: Ena tableta vsebuje 1,0 mg pramipeksolijevega diklorida monohidrata, kar ustreza 0,7 mg pramipeksola.
English: España
Slovenian: Danmark
English: Co-administration of antipsychotic medicinal products with pramipexole should be avoided (see section 4.4), e.g. if antagonistic effects can be expected.
Slovenian: Antipsihotiki Izogibati se moramo sočasnemu predpisovanju antipsihotikov in pramipeksola (glejte poglavje 4.4),
English: Ascending dose schedule of Pramipexole Teva Week
Slovenian: Shema povečevanja odmerkov zdravila Pramipeksol Teva
English: Dyspnoea hiccups
Slovenian: UAB Sicor Biotech
English: Dose reduction/tapered discontinuation should be considered if such symptoms develop.
Slovenian: Če se razvijejo takšni simptomi je treba razmisliti o zmanjšanju odmerka ali postopni ukinitvi zdravila.
English: A precise frequency estimation is not possible as the side effect did not occur in a clinical trial database of 2,762 patients with Parkinson's Disease treated with pramipexole.
Slovenian: 2.762 bolnikih s Parkinsonovo boleznijo, ki so se zdravili s pramipeksolom.
English: Frequency cannot be estimated from the available data
Slovenian: Njegove pogostnosti ni možno natančno oceniti, ker se ni pojavil v zbirki podatkov iz kliničnih preskušanj, v kateri so podatki o
English: Dopamine agonist withdrawal syndrome including apathy, anxiety, depression, fatigue, sweating and pain
Slovenian: vključno z apatijo, anksioznostjo, depresijo, utrujenostjo, znojenjem in bolečino.
English: Carton - Pramipexole Teva 0.088 mg Tablets
Slovenian: Samolepilna papirnata nalepka - Pramipeksol Teva 0,088 mg tablete IME ZDRAVILA
English: In patients with a creatinine clearance between 20 and 50 ml/min, the initial daily dose of Pramipexole Teva should be administered in two divided doses, starting at 0.088 mg of base (0.125 mg of salt) twice a day (0.176 mg of base/0.25 mg of salt daily).
Slovenian: (0,125 mg soli) dvakrat dnevno (0,176 mg h pramipeksola/0,25 mg soli na dan).
English: France
Slovenian: Deutschland
English: Since the daily dose for the treatment of Restless Legs Syndrome will not exceed 0.54 mg of base (0.75 mg of salt) Pramipexole Teva can be discontinued without tapering off.
Slovenian: Prekinitev zdravljenja Ker dnevni odmerek za zdravljenje sindroma nemirnih nog ni večji od 0,54 mg pramipeksola
English: Renal impairment
Slovenian: Motnje libida
English: Teva Pharma Belgium N.V./S.A./AG Tél/Tel: +32 38207373
Slovenian: Teva Pharma Belgium N.V./S.A./AG
English: During the first week, the usual dose is 1 tablet Pramipexole Teva 0.088 mg once a day (equivalent to 0.088 mg daily):
Slovenian: Običajni odmerek za prvi teden zdravljenja je 1 tableta zdravila Pramipeksol Teva po 0,088 mg
English: Blister - Pramipexole Teva 0.35 mg Tablets
Slovenian: Samolepilna papirnata nalepka - Pramipeksol Teva 0,35 mg tablete IME ZDRAVILA
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Teva B.V.
Slovenian: IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM
English: 63 % of patients on pramipexole and 52 % of patients on placebo reported at least one adverse drug reaction.
Slovenian: O najmanj enem neželenem učinku je poročalo 63 % bolnikov zdravljenih s pramipeksolom in 52 %
English: Nederland Teva Nederland B.V. Tel: +31 8000228400
Slovenian: Tel: +31 8000228400
English: UAB Sicor Biotech Tel: +370 52660203
Slovenian: Tel: +370 52660203
English: Blister - Pramipexole Teva 0.7 mg tablets
Slovenian: Samolepilna papirnata nalepka - Pramipeksol Teva 0,7 mg tablete IME ZDRAVILA
English: • Visual impairment
Slovenian: Očesne bolezni motnje vida,
English: Blister - Pramipexole Teva 0.18 mg tablets
Slovenian: Pretisni omot - Pramipeksol Teva 0,18 mg tablete IME ZDRAVILA
English: Carton - Pramipexole Teva 0.18 mg tablets
Slovenian: Samolepilna papirnata nalepka - Pramipeksol Teva 0,18 mg tablete IME ZDRAVILA
English: • Hiccups
Slovenian: • omotica
English: This is especially important
Slovenian: To je še posebej pomembno:
English: A specific antidote is not available.
Slovenian: Specifičnega antidota ni na voljo.
English: Via del Murillo Km 2.800 04013 Sermoneta Latina, Italy <{tel}> <{fax}> <{e-mail}>
Slovenian: Via del Murillo Km 2.800 04013 Sermoneta Latina, Italija <{tel.}> <{faks}> <{e-pošta}>
English: - if you have any infections.
Slovenian: - Če imate kakršno koli okužbo.
English: {Name and address} <{tel}> <{fax}> <{e-mail}>
Slovenian: {Ime in naslov} <{tel.}> <{faks}> <{e-pošta}>
English: Manufacturer Corden Pharma Latina S.p.A.
Slovenian: Corden Pharma Latina S.p.A.
English: Treatment is symptomatic.
Slovenian: Zdravljenje je simptomatsko.
English: This medicinal product is authorised in the Member States of the EEA under the following names:
Slovenian: To zdravilo je odobreno v državah članicah EGP pod naslednjimi imeni:
English: Close monitoring of INR is recommended.
Slovenian: Priporoča se skrbno spremljanje vrednosti INR.
English: Not known (frequency cannot be estimated from the available data)
Slovenian: Neznana pogostnost (ni mogoče oceniti iz razpoložljivih podatkov):
English: The daily dose may sometimes be split to be taken morning and evening.
Slovenian: Dnevne odmerke je včasih mogoče razdeliti na jutranji in večerni odmerek.
English: These may be signs of a severe allergic reaction.
Slovenian: To so lahko znaki hude alergijske reakcije.
English: The product information may be subsequently updated by the Member State competent authorities, in liaison with the reference Member State, as appropriate, in accordance with the procedures laid down in Chapter 4 of Title III of Directive 2001/83/EC.
Slovenian: Informacije o zdravilu se lahko naknadno posodobijo s strani pristojnega organa države članice v povezavi z referenčno državo članico, kot je primerno v skladu s postopki, opisanimi v poglavju 4 pod naslovom III Direktive 2001/83/ES.
English: Currently available data are described in section 5.2 but no recommendation on a posology can be made.
Slovenian: Trenutno razpoložljivi podatki so opisani v poglavju 5.2, vendar priporočil o odmerjanju ni mogoče dati.
English: This product information is the outcome of the referral procedure to which this Commission decision relates.
Slovenian: Te informacije o zdravilu so rezultat napotitvenega postopka, na katerega se nanaša sklep Evropske komisije.
English: The doctor may sometimes prescribe a different dose particularly if you have kidney problems.
Slovenian: Zdravnik lahko včasih predpiše drugačen odmerek, še posebej, če imate težave z ledvicami.
English: • changes in skin colour (pigmentation)
Slovenian: • spremembe barve kože (pigmentacija)
English: Most such adverse reactions are reversible if detected early.
Slovenian: Večina neželenih učinkov je reverzibilnih, če jih odkrijemo dovolj zgodaj.
English: - if you have had radiotherapy or chemotherapy recently.
Slovenian: - Če ste pred kratkim prejeli radioterapijo ali kemoterapijo.
English: • blood disorders (this is why you will be having blood tests between courses of treatment)
Slovenian: • krvne bolezni (zato boste morali opravljati krvne preiskave med cikli zdravljenja)
English: • increased bilirubin
Slovenian: • zvišan bilirubin
English: Effective anti-cancer treatment can destroy cancer cells rapidly in large numbers.
Slovenian: Učinkovito zdravilo proti raku lahko hitro uniči rakave celice v velikem številu.
English: 75% of dose
Slovenian: 75 % običajnega odmerka
English: Detailed information on this medicinal product is available on the website of [name of MS Agency link].
Slovenian: Podrobne informacije o zdravilu so objavljene na spletni strani [ime agencije v državi članicipovezava].
English: Take the empty container and any remaining capsules with you.
Slovenian: Prazno ovojnino in morebitne preostale kapsule vzemite s seboj.
English: Carcinogenic potential
Slovenian: Kancerogeni potencial
English: It is also present in human plasma, presumably as the trans isomer.
Slovenian: Nahaja se tudi v plazmi, verjetno v obliki trans izomera.
English: Excipients with known effect:
Slovenian: Pomožne snovi z znanim učinkom:
English: The dose you receive will be specific to you, which the doctor will calculate.
Slovenian: Odmerek, ki ga boste prejeli, bo zdravnik izračunal posebej za vas.
English: Mutagenic potential
Slovenian: Mutageni potencial
English: In order to prevent this, your doctor will need to do regular blood tests to monitor the level of these substances during treatment with this medicine.
Slovenian: Za preprečevanje tega neželenega učinka bo moral vaš zdravnik opravljati redne krvne preiskave, da bo spremljal raven teh snovi med zdravljenjem s tem zdravilom.
English: Bone marrow recovery is usually complete by day 20, and no cumulative toxicity has been reported.
Slovenian: Kostni mozeg si navadno opomore do 20. dne, o kumulativni toksičnosti pa niso poročali.
English: • severe allergic reactions
Slovenian: • hude alergijske reakcije
English: - if you have low levels of a protein called albumin in your blood.
Slovenian: - Če imate v krvi nizke ravni beljakovine, imenovane albumin.
English: Capsules should be taken on an empty stomach.
Slovenian: Kapsule je treba vzeti na prazen želodec.
English: 100% of dose
Slovenian: 100 % običajnega odmerka
English: - if you have recently been given any live vaccines.
Slovenian: - Če ste pred kratkim prejeli katero koli živo cepivo.
English: Reversible alopecia, sometimes progressing to total baldness, was observed in up to 66% of patients treated with etoposide.
Slovenian: O reverzibilni alopeciji, ki je včasih napredovala do popolne plešavosti, so poročali pri do 66 % bolnikov, ki so se zdravili z etopozidom.
English: Women of childbearing potential/Contraception in males and females
Slovenian: Ženske v rodni dobi/kontracepcija pri moških in ženskah
English: Treatment should therefore be symptomatic and supportive, and patients should be closely monitored.
Slovenian: Zdravljenje je simptomatsko in podporno, bolnika je potrebno skrbno spremljati.
English: In children, approximately 55% of the dose is excreted in the urine as etoposide in 24 hours.
Slovenian: Pri otrocih se približno 55 % odmerka izloči z urinom kot etopozid v 24 urah.
English: The capsules should be taken with a glass of water on an empty stomach.
Slovenian: Kapsule vzemite s kozarcem vode na prazen želodec.
English: Although minor differences in pharmacokinetic parameters between genders have been observed, these are not considered clinically significant.
Slovenian: Čeprav so opazili manjše razlike v farmakokinetičnih parametrih med spoloma, se te ne smatrajo za klinično pomembne.
English: • temporary blindness
Slovenian: • začasna slepota
English: Low serum albumin
Slovenian: Nizke vrednostmi serumskih albuminov
English: DO NOT take a double dose to make up for the forgotten dose.
Slovenian: Ne vzemite dvojnega odmerka, če ste pozabili vzeti prejšnji odmerek.
English: 15-50 mL/min
Slovenian: 15 do 50 ml/min
English: Microtubule assembly is not affected.
Slovenian: Ne vpliva na mikrotubularno strukturo.
English: Alopecia
Slovenian: Alopecija
English: Stop taking the medicine and tell your doctor immediately if you get any of the following symptoms: swelling of your tongue or throat, breathing difficulties, fast heartbeat, flushing of the skin or a rash.
Slovenian: Takoj prenehajte z jemanjem zdravila in obvestite zdravnika, če se pri vas pojavijo naslednji simptomi: otekanje jezika ali grla, težave z dihanjem, hiter srčni utrip, vročinski oblivi ali izpuščaj.
English: - if you have liver or kidney problems.
Slovenian: - Če imate težave z jetri ali ledvicami.
English: - If you have recently been given a live vaccine, including Yellow fever vaccine.
Slovenian: - Če ste bili pred kratkim cepljeni z živim cepivom, vključno s cepivom proti rumeni mrzlici.
English: These adverse reactions presented by system organ class and frequency, which is defined by the following categories: very common (≥1/10), common (≥1/100, <1/10), uncommon (≥1/1, 000, <1/100), rare (≥1/10, 000, <1/1,000), not known (cannot be estimated from the available data).
Slovenian: Kategorije pogostnosti so opredeljene 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), neznana (ni mogoče oceniti iz razpoložljivih podatkov).
English: On very rare occasions this may cause harmful amounts of substances from these cancer cells to be released into the blood.
Slovenian: V zelo redkih primerih se lahko škodljive količine snovi iz teh rakavih celic, sprostijo v krvni obtok.
English: Gastrointestinal Toxicity
Slovenian: Gastrointestinalna toksičnost
English: If you have reduced liver or kidney function, your doctor may also want you to take regular blood tests to monitor these levels.
Slovenian: Če imate zmanjšano delovanje jeter ali ledvic, bo vaš zdravnik morda želel opravljati redne krvne preiskave za spremljanje ravni delovanja.
English: Appropriate preventive measures should also be considered in patients at risk of this complication of therapy.
Slovenian: Razmisliti je treba tudi o ustreznih preventivnih ukrepih pri bolnikih, pri katerih obstaja tveganje za tovrsten zaplet zdravljenja.
English: The safety and efficacy of VEPESID and associated names in children below 18 years of age have not been established.
Slovenian: Varnost in učinkovitost zdravila VEPESID in povezana imena pri otrocih, mlajših od 18 let, še nista bili dokazani.
English: Lactation (see section 4.6)
Slovenian: Dojenje (glejte poglavje 4.6).
English: Close monitoring of patients is needed to detect early signs of tumour lysis syndrome, especially in patients with risk factors such as bulky treatmentsensitive tumours, and renal insufficiency.
Slovenian: Potrebno je natančno spremljanje bolnikov za zaznavo zgodnjih znakov sindroma tumorske lize, še posebej pri bolnikih z dejavniki tveganja, kot so na zdravljenje občutljivi obsežni tumorji in ledvična odpoved.
English: The mean volumes of distribution at steady state fall in the range of 18 to 29 liters or 7 to 17 L/m2.
Slovenian: Srednji volumen porazdelitve v stanju dinamičnega ravnovesja je od 18 do 29 litrov, ali od 7 do 17 l/m2.