natgillin/translations-raw huggingface dataset:
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.
Novartis Pharmaceuticals UK Limited, Frimley Business Park, Frimley, Camberley, Surrey GU16 7SR, United Kingdom 
Novartis Pharmaceuticals UK Limited, Frimley Business Park, Frimley, Camberley, Surrey GU16 7SR, Velika Britanija
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
ANNEX I 
PRILOGA I
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.
In a randomised, comparative Phase III study conducted by the Gynecologic Oncology Group (GOG 0179), topotecan plus cisplatin (n = 147) was compared with cisplatin alone (n = 146) for the treatment of histologically confirmed persistent, recurrent or Stage IVB carcinoma of the cervix where curative treatment with surgery and/or radiation was not considered appropriate. 
V randomizirani primerjalni študiji faze III, ki jo je izvedla ginekološka onkološka skupina (študija GOG 0179), so primerjali topotekan in cisplatin (n = 147) s cisplatinom samim (n = 146) pri zdravljenju histološko potrjenega persistentnega rekurentnega karcinoma materničnega vratu ali karcinoma materničnega vratu v stadiju IVB, kjer kurativno zdravljenje s kirurškim posegom in/ali obsevanjem ni bilo primerno.
Age/weight 
Starost/telesna masa
In course 1 the incidence was 20%, by course 4 the incidence was 8%. 
V 1. ciklusu je bila incidenca 20 %, do 4. ciklusa pa se je zmanjšala na 8 %.
Pharmacotherapeutic group: antineoplastic agents, other antineoplastic agents: ATC code: L01XX17. 
Farmakoterapevtska skupina: zdravila z delovanjem na novotvorbe (citostatiki), druga zdravila z delovanjem na novotvorbe (citostatiki), oznaka ATC: L01XX17
Topotecan-induced neutropenia can cause neutropenic colitis. 
S topotekanom povzročena nevtropenija lahko povzroči nevtropenični kolitis.
Resulting from its mechanism of action, topotecan is genotoxic to mammalian cells (mouse lymphoma cells and human lymphocytes) in vitro and mouse bone marrow cells in vivo. 
Topotekan je zaradi svojega mehanizma delovanja genotoksičen za celice sesalcev (celice limfoma pri miših in človeške limfocite) in vitro in za celice kostnega mozga pri miših in vivo.
Do not take Hycamtin: 
Ne jemljite zdravila Hycamtin:
ANNEX III 
PRILOGA III
The most frequently reported non-haematological effects were nausea (37%), diarrhoea (29%), fatigue (26%), vomiting (24%), alopecia (21%) and anorexia (18%). 
Najpogosteje opisani nehematološki učinki so bili: navzea (37 %), driska (29 %), utrujenost (26 %), bruhanje (24 %), alopecija (21 %) in anoreksija (18 %).
Plasma clearance of total topotecan (active and inactive form) in patients with hepatic impairment only decreased by about 10% compared with the control group of patients. 
Plazemski očistek celotnega topotekana (aktivne in neaktivne oblike) se je pri teh bolnikih v primerjavi s kontrolno skupino zmanjšal le za približno 10 %.
The signs and symptoms observed following overdose were consistent with the known undesirable events associated with topotecan (see section 4.8). 
Znaki in simptomi, ki so jih opažali po prevelikem odmerjanju, so bili v skladu z znanimi neželenimi učinki topotekana (glejte poglavje 4.8).
Your doctor will determine the correct dose of cisplatin. 
Ustrezni odmerek cisplatina vam bo predpisal zdravnik.
You should not receive Hycamtin: 
Zdravila Hycamtin ne smete prejeti:
Death due to sepsis occurred in 1% of patients. 
Do smrti zaradi sepse je prišlo pri 1 % bolnikov.
HYCAMTIN capsules are indicated as monotherapy for the treatment of adult patients with relapsed small cell lung cancer (SCLC) for whom re-treatment with the first-line regimen is not considered appropriate (see section 5.1). 
Kapsule HYCAMTIN so indicirane kot monoterapija za zdravljenje odraslih bolnikov s ponovitvijo drobnoceličnega pljučnega raka, pri katerih ponovno zdravljenje s terapijo prve linije ni primerno (glejte poglavje 5.1).
Doses should be similarly reduced if the platelet count falls below 25 x 10 
Podobno je treba zmanjšati odmerke, če se število trombocitov zniža pod 25 x 10
For patients who experience Grade 3 or 4 diarrhoea, the dose should be reduced by 0.4 mg/m2/day for subsequent courses (see section 4.4). 
Pri bolnikih z drisko stopnje 3 ali 4 je potrebno odmerek zmanjšati za 0,4 mg/m2/dan pri naslednjih ciklusih (glejte poglavje 4.4).
In reproductive toxicity studies with topotecan in rats there was no effect on male or female fertility; however, in females super-ovulation and slightly increased pre-implantation loss were observed. 
V študijah vpliva na sposobnost razmnoževanja pri podganah topotekan ni vplival na plodnost samcev ali samic, so pa pri samicah opazili superovulacijo in rahel porast predimplantacijskih izgub.
The product should be used immediately after it is prepared for infusion. 
Zdravilo morate uporabiti takoj, ko ga pripravite za infundiranje.
If either cisplatin or carboplatin is given on day 1 of the topotecan dosing, a lower dose of each agent must be given to improve tolerability compared to the dose of each agent which can be given if the platinum agent is given on day 5 of the topotecan dosing. 
Če prejme cisplatin ali karboplatin na 1. dan dajanja topotekana, je potrebno zaradi boljšega prenašanja zmanjšati odmerek vsakega od teh zdravil v primerjavi z odmerki, ki jih je mogoče dajati, kadar bolnik prejme zdravilo s platino na 5. dan uporabe topotekana.
• The other ingredients are: hydrogenated vegetable oil, glyceryl monostearate, gelatin, titanium dioxide (E171), and for 1 mg capsules only, red iron oxide (E172). 
• Druge sestavine zdravila so: hidrogenirano rastlinsko olje, glicerilmonostearat, želatina, titanov dioksid (E171), samo v 1-miligramskih kapsulah tudi rdeči železov oksid (E172).
• Cervical cancer: 0.75 mg per square metre of body surface area per day. 
• rak materničnega vratu: 0,75 mg na kvadratni meter telesne površine na dan.
Overall recovery of topotecan-related material following five daily doses of topotecan was 49 to 72% (mean 57%) of the administered oral dose. 
Celokupno izločanje s topotekanom povezanih snovi po uporabi petih dnevnih odmerkov topotekana je znašalo od 49 do 72 % (povprečje 57 %) uporabljenega peroralnega odmerka.
Ovarian and small cell lung carcinoma Initial dose 
Karcinom jajčnika in drobnocelični pljučni karcinom Začetni odmerek
The median time to onset of Grade 2 or worse diarrhoea was 9 days. 
Mediani čas do pojava driske 2. ali hujše stopnje je bil 9 dni.
The response rate in the whole ovarian carcinoma programme (n = 392, all previously treated with cisplatin or cisplatin and paclitaxel) was 16%. 
Stopnja odziva na zdravilo za celoten program študij raka na jajčnikih (n = 392, pri bolnicah, ki so se pred tem zdravile s cisplatinom ali cisplatinom in paklitakselom) je bila 16 %.
The capsules are printed with black ink that contains black iron oxide (E172), shellac, anhydrous ethanol, propylene glycol, isopropyl alcohol, butanol, concentrated ammonia solution and potassium hydroxide. 
Kapsule so označene s črnim barvilom, ki vsebuje črni železov oksid (E172), šelak, brezvodni etanol, propilenglikol, izopropilalkohol, butanol, koncentrirano raztopino amoniaka in kalijev hidroksid.
Handling and disposal 
Ravnanje z zdravilom in odstranjevanje
The extent of exposure was similar following a high-fat meal and in the fasted state, while tmax was delayed from 1.5 to 3 hours (topotecan lactone) and from 3 to 4 hours (total topotecan). 
Izpostavljenost učinkovini je bila po mastnem obroku in na tešče podobna, tmax pa se je podaljšal z 1,5 na 3 ure (topotekanov lakton) oz. s 3 na 4 ure (celotni topotekan).
Table 1 Summary of survival, response rate, and time to progression in SCLC patients treated with oral or intravenous topotecan 
Povzetek preživetja, deleža odziva in časa do napredovanja pri bolnikih z drobnoceličnim pljučnim rakom, zdravljenih s peroralnim oziroma intravenskim topotekanom
• All items for administration or cleaning, including gloves, should be placed in high-risk, waste disposal bags for high-temperature incineration. 
• Vse pripomočke, ki jih potrebujete pri dajanju zdravila ali čiščenju, tudi rokavice, morate odvreči v vreče za shranjevanje nevarnih odpadkov, ki so namenjene sežigu pri visokih temperaturah.
Limited data indicate that the dose should be reduced in patients with moderate renal impairment. 
Majhno število podatkov, ki so na voljo, kaže, da je treba pri zdravljenju bolnikov z zmerno ledvično okvaro odmerek zmanjšati.
If you are being treated for cervical cancer, you may get side effects from the other medicine (cisplatin) that you will be given along with Hycamtin. 
Če se zdravite zaradi raka materničnega vratu, se lahko pojavijo neželeni učinki drugega zdravila (cisplatina), ki ga boste prejeli skupaj z zdravilom Hycamtin.
Similar results were obtained if glomerular filtration rate (ml/min) was estimated using the MDRD formula corrected for body weight. 
Rezultati so bili podobni tudi v primerih, ko so hitrost glomerulne filtracije (ml/min) izračunali na osnovi enačbe MDRD s prilagoditvijo na telesno maso bolnika.
In a population of patients with refractory SCLC (those not responding to first-line therapy), the response rate to topotecan was 4.0%. 
V skupini bolnikov z neodzivnim drobnoceličnim pljučnim rakom (pri katerih ni prišlo do odziva na zdravljenje prve linije) je bil odziv na topotekan 4,0-odstoten.
• ovarian cancer or small cell lung cancer that has come back after chemotherapy. 
• raka na jajčniku ali drobnoceličnega pljučnega raka, ki se je ponovil po kemoterapiji.
• Allergic or hypersensitivity reactions (including rash). 
• alergijske ali preobčutljivostne reakcije (vključno s pojavom izpuščaja);
Intravenous topotecan should be considered in the following clinical situations: uncontrolled emesis, swallowing disorders, uncontrolled diarrhoea, clinical conditions and medication that may alter gastrointestinal motility and drug absorption. 
Uporaba intravenskega topotekana pride v poštev v naslednjih kliničnih okoliščinah: pri neobvladanem bruhanju, motnjah požiranja, neobvladani driski ter v kliničnih stanjih ali med uporabo zdravil, ki lahko vplivajo na gibljivost prebavil in absorpcijo zdravil.
Personnel 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.