natgillin/translations-raw huggingface dataset:
Paediatric population The safety and effectiveness of oral topotecan in paediatric patients have not been established.
Pediatrična populacija Varnost in učinkovitost peroralnega topotekana pri pediatričnih bolnikih nista ugotovljeni.
• if your blood cell counts are too low.
• če imate prenizko število krvnih celic.
• Staff should be trained to reconstitute the medicinal product.
• Osebje mora biti ustrezno izurjeno za rekonstitucijo zdravila.
Patients with creatinine clearance >60 ml/min have been included in efficacy/safety studies of topotecan.
Bolniki z očistkom kreatinina >60 ml/min so bili vključeni v študijo o učinkovitosti/varnosti topotekana.
• if you have any kidney or liver problems.
• če imate kakršne koli težave z ledvicami ali jetri.
If you have more than 3 episodes of diarrhoea per day you should contact your doctor immediately.
Če imate drisko več kot 3-krat na dan, se morate nemudoma posvetovati z zdravnikom.
Before you are given this medicine your doctor needs to know:
Preden boste prejeli to zdravilo, morate zdravniku povedati:
This can even be life threatening.
To je lahko tudi smrtno nevarno.
The pharmacokinetics of topotecan given as a 30-minute infusion for 5 days were evaluated in two studies.
Farmakokinetiko topotekana, ki so ga dajali v obliki 30-minutne infuzije 5 dni, so ovrednotili v dveh študijah.
Taking out a capsule These capsules come in special packaging to prevent children removing them.
Kako vzamete kapsulo iz pakiranja Kapsule so zaprte v posebnem pakiranju, ki preprečuje, da bi jih iz njega vzeli otroci.
Your doctor will tell you whether this is the case, based on the results of your last blood test.
To vam bo povedal zdravnik na podlagi izvida vaše zadnje preiskave krvi.
In this analysis, creatinine clearance was calculated using the Cockcroft-Gault method.
V tej analizi so očistek kreatinina izračunali s Cockcroft-Gaultovo enačbo.
• Yellow skin.
rumena koža.
There may be a higher than usual chance of you getting side effects if you are also being treated with cyclosporin A. You will be monitored closely if you are taking both these medicines.
Verjetnost neželenih učinkov je lahko večja kot sicer, če dobivate tudi zdravilo ciklosporin A. Med uporabo teh dveh zdravil vas bodo natančno nadzirali.
• your body size (surface area measured in square metres)
• velikost vašega telesa (telesno površino, izraženo v kvadratnih metrih),
Standard oncology practice for the management of neutropenia is either to administer topotecan with other medicinal products (e.g. G-CSF) or to reduce the dose to maintain neutrophil counts.
Standardna onkološka praksa za obvladovanje nevtropenije je bodisi uporaba topotekana z drugimi zdravili (npr. G-CSF) bodisi zmanjšanje odmerka za ohranitev števila nevtrofilcev.
The frequency of some side effects is not known (events from spontaneous reports and the frequency cannot be estimated from the available data):
Za nekatere neželene učinke pogostnost ni znana (podatki o njih izhajajo iz spontanih poročil, tako da njihove pogostnosti ni mogoče ugotoviti iz razpoložljivih podatkov).
All cases were irrespective of associated causality.
Vsi primeri so bili zabeleženi ne glede na vzročno povezanost z zdravilom.
• the results of blood tests carried out before treatment
• izvide krvnih preiskav, opravljenih pred začetkom zdravljenja,
Your doctor will decide with you whether Hycamtin therapy is better than further treatment with your initial chemotherapy.
Zdravnik bo skupaj z vami presodil, ali je zdravljenje z zdravilom Hycamtin za vas boljše kot nadaljevanje zdravljenja s predhodno obliko kemoterapije.
A doctor or a nurse will give you the medicine as an infusion into a vein in hospital.
Zdravilo vam bo dal zdravnik ali medicinska sestra v obliki infuzije v žilo v bolnišnici.
Hycamtin capsules may be taken with or without food (see section 5.2).
Kapsule zdravila Hycamtin lahko vzame s hrano ali brez nje (glejte poglavje 5.2).
For storage conditions after reconstitution and dilution of the medicinal product, see section 6.3.
Za pogoje shranjevanja po rekonstituciji in redčenju zdravila glejte poglavje 6.3.
The normal procedures for proper handling and disposal of anticancer medicinal products should be adopted, namely:
Upoštevati morate običajne postopke za ustrezno ravnanje z zdravili proti raku in njihovo odstranjevanje, in sicer:
Korean patients with renal impairment had generally higher exposure than non-Asian patients with the same degree of renal impairment.
Pri korejskih bolnikih z ledvično okvaro je bila izpostavljenost na splošno večja kot pri neazijskih bolnikih z enako stopnjo ledvične okvare.
The overall incidence of drug-related diarrhoea was 22%, including 4% with Grade 3 and 0.4% with Grade 4.
Skupna incidenca z zdravilom povezane driske je bila 22 %, vključno s 4 % 3. stopnje in 0,4 % 4. stopnje.
Do not try to become pregnant until a doctor advises you it is safe to do so.
Ne poskušajte zanositi, dokler vam zdravnik ne pove, da je to varno.
If well tolerated, treatment may continue until disease progression (see sections 4.8 and 5.1).
Če bolniki zdravljenje dobro prenašajo, je mogoče z njim nadaljevati, dokler bolezen ne napreduje (glejte poglavji 4.8 in 5.1).
Anti-tumour activity was demonstrated primarily in patients with neuroblastoma.
Protitumorsko delovanje je bilo dokazano predvsem pri bolnikih z nevroblastomom.
Topotecan also had a high volume of distribution, about 132 l (SD 57), and a relatively short half-life of 2-3 hours.
Topotekan ima tudi velik volumen porazdelitve, približno 132 l (s standardno deviacijo 57), in sorazmerno kratko razpolovno dobo, 2-3 ure.
If your partner becomes pregnant during your treatment, tell your doctor immediately.
Če med zdravljenjem zanosi vaša partnerka, o tem takoj obvestite zdravnika.
The usual dose
Običajni odmerek
Separate one capsule: tear along the perforated lines to separate one capsule “pocket” from the strip.
Ločite eno kapsulo: odtrgajte vzdolž perforiranih črt, da boste en "žep" s kapsulo ločili od traku.
Vials 3 years.
Viale 3 leta
• advanced cervical cancer if surgery or radiotherapy treatment is not possible.
• napredovalega raka materničnega vratu, če zdravljenje z operacijo ali obsevanjem ni možno.
Drug-related diarrhoea was more frequent in patients 65 years of age (28%) compared to those less than 65 years of age (19%).
Z zdravilom povezana driska je bila pogostejša med bolniki, starimi 65 let (28 %), kot med bolniki, mlajšimi od 65 let (19 %).
Instructions on how to reconstitute, store and dispose of Hycamtin
Navodila za rekonstitucijo, shranjevanje in odstranjevanje zdravila Hycamtin
Hycamtin contains ethanol This medicine contains small amounts of ethanol (alcohol).
Zdravilo Hycamtin vsebuje alkohol Zdravilo vsebuje majhno količino etanola (alkohola).
This pattern of treatment will normally be repeated every 3 weeks.
Tak režim zdravljenja boste praviloma prejemali vsake 3 tedne.
Justification for not including Braille accepted
Sprejeta je utemeljitev, da Braillova pisava ni potrebna
• the disease being treated.
• bolezen, zaradi katere se zdravite.
A. MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE
A. IZDELOVALCI, ODGOVORNI ZA SPROŠČANJE SERIJ
Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu/.
Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila http://www.ema.europa.eu/.
This should be taken into account when prescribing HYCAMTIN, e.g. if patients at increased risk of tumour bleeds are considered for therapy.
To je treba upoštevati pri predpisovanju zdravila Hycamtin, npr. pri odločanju za zdravljenje bolnikov, pri katerih obstaja večje tveganje za krvavitve tumorja.
Median survival was 30.3 weeks (95% CI: 27.6, 33.4).
Mediana časa preživetja je bila 30,3 tedna (95-odstotni IZ: 27,6, 33,4).
Your dose of Hycamtin may need to be adjusted.
Odmerek zdravila Hycamtin bo morda treba prilagoditi.
• Mild pain and inflammation at the site of injection.
• blaga bolečina in vnetje na mestu injiciranja zdravila;
Limited data in Korean patients with creatinine clearance less than 50 ml/min suggest a further lowering of dose may be required (see section 5.2).
Omejeni podatki, ki so na voljo za korejske bolnike z očistkom kreatinina <50 ml/min, so pokazali, da bi bilo lahko potrebno nadaljnje zmanjšanje odmerka (glejte poglavje 5.2).
Clinical guidelines describing the aggressive management of CTID include specific recommendations on patient communication and awareness, recognition of early warning signs, use of anti-diarrhoeals and antibiotics, changes in fluid intake and diet, and need for hospitalisation (see sections 4.2 and 4.8).
Klinične smernice za odločno obvladovanje driske zaradi zdravil proti raku vključujejo specifična priporočila za informiranje in ozaveščanje bolnika, prepoznavanje zgodnjih opozorilnih znakov, uporabo antidiaroikov in antibiotikov, spremembe v uživanju tekočin in prehrani ter sprejem v bolnišnico (glejte poglavji 4.2 in 4.8).
Topotecan must be reconstituted and further diluted before use (see section 6.6).
Pred uporabo je treba topotekan rekonstituirati in nato še nadalje razredčiti (glejte poglavje 6.6).
A cross-study analysis in 217 patients with advanced solid tumours indicated that gender did not affect the pharmacokinetics of HYCAMTIN capsules to a clinically relevant extent.
Analiza navzkrižne študije 217 bolnikov z napredovalimi čvrstimi tumorji je pokazala, da spol ne vpliva klinično pomembno na farmakokinetiko zdravila HYCAMTIN v kapsulah.
The dose (and number of capsules) of Hycamtin you are given will be worked out by your doctor, based on:
Odmerek (in število kapsul) zdravila Hycamtin, ki ga boste dobili, bo zdravnik določil glede na:
As would be expected, patients with poor performance status (PS >1) have a lower response rate and an increased incidence of complications such as fever, infection and sepsis (see section 4.8).
Kot je mogoče pričakovati, se bolniki s slabšo telesno zmogljivostjo (performance status, PS >1) slabše odzivajo na zdravilo, večja pa je tudi pogostnost zapletov, kot so zvišana telesna temperatura, okužbe in sepsa (glejte poglavje 4.8).
In addition, 5% of all patients treated (1% of courses) developed sepsis (see section 4.4).
Poleg tega je pri 5 % vseh zdravljenih bolnikov (v 1 % ciklusov zdravljenja) prišlo do sepse (glejte poglavje 4.4).
The powder needs to be reconstituted and diluted before infusion.
Pred infuzijo je treba prašek rekonstituirati in razredčiti.
Other than hydrolysis, topotecan is cleared predominantly renally, with a minor component metabolised to the N-desmethyl metabolite (SB-209780) identified in plasma, urine and faeces.
Poleg hidrolize se topotekan odstrani predvsem skozi ledvice, manjši del pa se ga presnovi v N-desmetilni presnovek (SB-209780), ki se pojavi v plazmi, urinu in blatu.
In a population study, a number of factors including age, weight and ascites had no significant effect on clearance of total topotecan (active and inactive form).
V populacijski študiji številni dejavniki, vključno s starostjo, telesno maso in ascitesom, niso pomembno vplivali na očistek celotnega topotekana (aktivne in neaktivne oblike).
The bioavailability of oral topotecan (total and lactone) in humans is approximately 40%.
Biološka uporabnost peroralnega topotekana (celotnega in laktona) je pri človeku približno 40 %.
• Feeling generally weak and tired (temporary anaemia).
• občutek splošne oslabelosti in utrujenosti (prehodna anemija).
If you forget to take Hycamtin
Če ste pozabili vzeti zdravilo Hycamtin
There are no data from Asian patients with renal impairment other than Koreans.
Podatki za azijske bolnike z ledvično okvaro so na voljo le za Korejce.
What Hycamtin is and what it is used for
Kaj je zdravilo Hycamtin in za kaj ga uporabljamo
Other medicines and Hycamtin
Druga zdravila in zdravilo Hycamtin
As with all cytotoxic chemotherapy, patients being treated with topotecan must be advised that they or their partner must use an effective method of contraception.
Kot velja za vsako citotoksično kemoterapijo, je treba bolnikom, ki prejemajo topotekan, svetovati, naj uporabljajo učinkovito kontracepcijo sami oziroma naj jo uporablja njihov partner.
Accurate assessment of performance status at the time therapy is given is important, to ensure that patients have not deteriorated to PS 3.
Pomembno je, da se bolnikova telesna zmogljivost ob začetku zdravljenja natančno oceni in zagotovi, da se ocena PS ne poslabša na 3.
Topotecan is a substrate for both ABCB1 (P-glycoprotein) and ABCG2 (BCRP).
Topotekan je substrat ABCB1 (glikoproteina P) in ABCG2 (prenašalca BCRP).
Topotecan was also evaluated in the paediatric population; however, only limited data on efficacy and safety are available.
Topotekan so proučevali tudi pri pediatrični populaciji, vendar je podatkov o učinkovitosti in varnosti pri tej skupini bolnikov malo.
If the capsules are punctured or leaking, you should immediately wash your hands thoroughly with soap and water.
Če so preluknjane ali puščajo, si roke nemudoma temeljito umijte z milom in vodo.
Hycamtin helps to destroy tumours.
Zdravilo Hycamtin pomaga uničevati tumorje.
Marketing Authorisation Holder Novartis Europharm Limited Vista Building
Imetnik dovoljenja za promet z zdravilom Novartis Europharm Limited Vista Building
Reconstituted and diluted solutions
Rekonstituirane in razredčene raztopine
Underlying risk factors include history of ILD, pulmonary fibrosis, lung cancer, thoracic exposure to radiation and use of pneumotoxic substances and/or colony stimulating factors.
Med osnovnimi dejavniki tveganja so anamneza IBP, pljučna fibroza, rak pljuč, izpostavljenost prsnega koša obsevanju in uporaba pnevmotoksičnih snovi in/ali kolonijo stimulirajočih faktorjev.
In patients presenting with fever, neutropenia and a compatible pattern of abdominal pain, the possibility of neutropenic colitis should be considered.
Pri bolnikih s povišano telesno temperaturo, nevtropenijo in odgovarjajočo obliko bolečine v trebuhu je treba pomisliti na možnost nevtropeničnega kolitisa.
Topotecan half-life was increased by about 30% but no clear change in volume of distribution was observed.
Razpolovna doba topotekana se je podaljšala za 30 %, volumen porazdelitve pa se ni bistveno spremenil.
As with other cytotoxic medicinal products, topotecan can cause severe myelosuppression.
Tako kot druga citotoksična zdravila lahko tudi topotekan povzroči hudo mielosupresijo.
Metabolism accounts for <10% of the elimination of topotecan.
Presnova predstavlja <10 % izločanja topotekana.
Comparison of pharmacokinetic parameters did not suggest any change in pharmacokinetics over the 5 days of dosing.
Primerjava farmakokinetičnih parametrov ni pokazala, da bi se farmakokinetika topotekana v 5 dneh uporabe spreminjala.
However in the two studies in which both oral and intravenous topotecan were administered, patients over 65 years old receiving oral topotecan experienced an increase in drugrelated diarrhoea compared to those younger than 65 years of age (see section 4.4 and 4.8).
A v dveh študijah, v katerih so bolnikom odmerjali tako peroralni kot intravenski topotekan, so pri bolnikih, ki so bili stari več kot 65 let in so prejemali peroralni topotekan, zabeležili več z zdravilom povezane driske kot pri tistih, ki so bili stari manj kot 65 let (glejte poglavji 4.4 in 4.8).
Topotecan should only be administered under the supervision of a physician experienced in the use of chemotherapy (see section 6.6).
Uporaba topotekana naj vedno poteka pod nadzorom zdravnika z izkušnjami na področju kemoterapije (glejte poglavje 6.6).
These data should be evaluated in the context of the overall safety profile of the medicinal product, in particular of the significant haematological toxicity (see section 4.8).
Pri vrednotenju teh podatkov je treba upoštevati vsa dejstva o varnosti zdravila, zlasti pomembne oblike hematološke toksičnosti (glejte poglavje 4.8).
Results of a cross-study analysis suggest that the exposure to topotecan lactone, the active moiety following topotecan administration, increases with decreased renal function.
Rezultati analize navzkrižne študije so pokazali, da se izpostavljenost topotekan laktonu, aktivni komponenti topotekana, poveča ob zmanjšani ledvični funkciji.
Although it is not known whether topotecan is excreted in human breast milk, breast-feeding should be discontinued at the start of therapy.
Čeprav ni znano, ali se topotekan izloča v materino mleko, morajo matere ob začetku zdravljenja s topotekanom prenehati dojiti.
How Hycamtin is given A doctor or nurse will administer Hycamtin as an infusion into your arm lasting about 30 minutes.
Zdravilo Hycamtin vam bo dal zdravnik ali medicinska sestra v obliki infuzije v roko, ki običajno teče približno 30 minut.
Pharmacokinetics of HYCAMTIN capsules have not been specifically studied in patients with impaired hepatic function.
Farmakokinetike kapsul HYCAMTIN niso posebej raziskali pri bolnikih z okvarjenim delovanjem jeter.
Combination therapy (cervical carcinoma):
Kombinirano zdravljenje (karcinom materničnega vratu):
You will have treatment once a day for 5 days.
Zdravilo boste prejemali enkrat na dan pet dni.
Capsule contents Hydrogenated vegetable oil Glyceryl monostearate
Vsebina kapsule hidrogenirano rastlinsko olje glicerilmonostearat
The topotecan-O-glucuronide and N-desmethyl topotecan-O-glucuronide in the urine were less than 2.0%.
Topotekan-O-glukuronid in N-desmetil topotekan-O-glukuronid v urinu predstavljata manj kot 2,0 %.
Hypersensitivity reactions including rash, urticaria, angioedema and anaphylactic reactions have been reported rarely.
O preobčutljivostnih reakcijah, vključno z izpuščajem, urtikarijo, angioedemom in anafilaktičnimi reakcijami, so poročali redko.
In patients refractory to or relapsing within 3 months after cisplatin therapy (n = 186), the response rate was 10%.
Pri bolnicah, ki se jim je bolezen po zdravljenju s cisplatinom ponovila v roku 3 mesecev ali ki se niso odzvale na zdravilo (n = 186), je bila stopnja odziva 10 %.
Total or pronounced alopecia was observed in 30% of patients and partial alopecia in 15% of patients.
Popolna ali izrazita alopecija se je pojavila pri 30 % bolnikov, delna pa pri 15 % bolnikov.
Proactive management of diarrhoea with anti-diarrhoeal agents is important.
Pomembno je proaktivno zdravljenje driske z antidiaroiki.
If topotecan is used during pregnancy, or if the patient becomes pregnant during therapy with topotecan, the patient must be warned of the potential hazards to the foetus.
Če bolnica uporablja topotekan med nosečnostjo ali če zanosi med zdravljenjem s topotekanom, je treba bolnico opozoriti na možne nevarnosti za plod.
Novartis Pharma GmbH, Roonstrasse 25, D-90429 Nuremberg, Germany
Novartis Pharma GmbH, Roonstrasse 25, 90429 Nürnberg, Nemčija
There were no signs of cumulative haematological or non-haematological toxicity.
Znakov kumulativne hematološke ali nehematološke toksičnosti niso ugotovili.
In clinical studies, topotecan was discontinued if the dose needed to be reduced below 1.5 mg/m 2/day.
V kliničnih študijah so topotekan prenehali uporabljati, če je bilo treba odmerek zmanjšati pod 1,5 mg/m 2/dan.
• Severe allergic or anaphylactic reactions.
• hude alergijske ali anafilaktične reakcije;
30-minute infusion for 5 days repeated every 3 weeks for up to one year depending on response to therapy.
Zdravljenje se je ponavljalo vsake 3 tedne in je trajalo do 1 leta, odvisno od odziva na zdravljenje.
Severe cases of diarrhoea may require administration of oral or intravenous electrolytes and fluids, and interruption of topotecan therapy (see sections 4.4 and 4.8).
V hudih primerih driske bo morda potrebno peroralno ali intravensko dajanje elektrolitov in tekočin ter prekinitev zdravljenja s topotekanom (glejte poglavji 4.4 in 4.8).
Topotecan does not inhibit human P450 enzymes (see section 5.2).
Topotekan ne zavira encimov človeškega citokroma P450 (glejte poglavje 5.2).
• If you have any further questions, ask your doctor or pharmacist.
• Če imate dodatna vprašanja, se posvetujte z zdravnikom ali farmacevtom.
A supplementary retrospective analysis was conducted on data from 523 patients with relapsed ovarian cancer.
Izvedena je bila še dodatna, retrospektivna analiza podatkov, pridobljenih pri 523 bolnicah, pri katerih se je rak na jajčnikih ponovil.
An N-desmethyl metabolite, which was shown to have similar or less activity than the parent in a cell-based assay, was found in urine, plasma and faeces.
Presnovek N-desmetil (za katerega so v celičnem testu dokazali, da ima podobno ali manjšo aktivnost kot matična učinkovina) so odkrili v urinu, plazmi in blatu.
You will have treatment once a day for 3 days.
Zdravilo boste prejemali enkrat na dan tri dni.
• Lung inflammation (interstitial lung disease): You are most at risk if you have existing lung disease, have had radiation treatment to your lungs, or have previously taken medicines that caused lung damage.
• vnetje pljuč (intersticijska bolezen pljuč): tveganje je največje, če že imate bolezen pljuč, če so vam pljuča obsevali ali če ste predhodno jemali zdravila, ki so povzročila okvaro pljuč.
A 5-HT3 antagonist was administered to 30% of patients in 24% of courses.
Antagonist 5-HT3 je dobilo 30 % bolnikov v 24 % ciklusov.
• Staff handling this medicinal product during reconstitution should wear protective clothing including mask, goggles and gloves.
• Osebje, ki pripravlja zdravilo, mora med rekonstitucijo nositi zaščitna oblačila, masko, zaščitna očala in rokavice.
Name and address of the manufacturers responsible for batch release
Ime in naslov izdelovalcev, odgovornih za sproščanje serij
Safety data are presented based on an integrated data set of 682 patients with relapsed lung cancer administered 2,536 courses of oral topotecan monotherapy (275 patients with relapsed SCLC and 407 with relapsed non-SCLC).
Podatki o varnosti so navedeni na podlagi celotnega nabora podatkov 682 bolnikov s ponovitvijo pljučnega raka, ki so dobili 2.536 ciklusov monoterapije s peroralnim topotekanom (275 bolnikov s ponovitvijo drobnoceličnega pljučnega raka in 407 bolnikov s ponovitvijo nedrobnoceličnega pljučnega raka).
When given in combination with cisplatin (cisplatin day 1, topotecan days 1 to 5), the clearance of topotecan was reduced on day 5 compared to day 1 (19.1 l/h/m compared to 21.3 l/h/m
Pri dajanju v kombinaciji s cisplatinom (cisplatin 1. dan, topotekan od 1. do 5. dan) je bil 5. dan očistek topotekana v primerjavi s 1. dnem manjši (19,1 l/uro/m v primerjavi z 21,3 l/uro/m
Among all patients treated in clinical studies (including both those with severe neutropenia and those who did not develop severe neutropenia), 11% (4% of courses) developed fever and 26% (9% of courses) developed infection.
11 % vseh bolnikov (v 4 % ciklusov zdravljenja), ki so se zdravili v kliničnih študijah (vključno z bolniki s hudo nevtropenijo in s tistimi, pri katerih se huda nevtropenija ni pojavila), je imelo zvišano telesno temperaturo, pri 26 % (v 9 % ciklusov zdravljenja) pa so se pojavile okužbe.
Remember to tell your doctor if you start to take any other medicines while you are on Hycamtin.
Ne pozabite zdravniku povedati, če med zdravljenjem z zdravilom Hycamtin začnete jemati katero koli drugo zdravilo.
Tell your doctor immediately if you get any symptoms of these conditions, as hospitalisation may be necessary.
Če opazite katerega koli od simptomov navedenih stanj, o tem nemudoma obvestite svojega zdravnika, saj bo morda potrebno zdravljenje v bolnišnici.
Serious side effects: tell your doctor These very common side effects may affect more than 1 in 10 people treated with Hycamtin:
Resni neželeni učinki: obvestite zdravnika Ti zelo pogosti neželeni učinki se lahko pojavijo pri več kot 1 od 10 bolnikov, ki se zdravijo z zdravilom Hycamtin:
In patients with moderate renal impairment topotecan plasma clearance was reduced to 34% of the value in control patients.
Pri bolnikih z zmerno okvaro ledvic se je plazemski očistek zmanjšal na 34 % vrednosti pri bolnikih v kontrolni skupini.
Driving and using machines Hycamtin can make people feel tired.
Vpliv na sposobnost upravljanja vozil in strojev Zdravilo Hycamtin lahko povzroča utrujenost.