FrancophonIA/ELRC3.0 huggingface dataset:
English: There is no known specific treatment for extravasation reactions.
Slovenian: Specifično zdravljenje za reakcije ekstravazacije ni poznano.
English: Twelve and then six hours before your infusion you will be given dexamethasone (a steroid), either as a tablet to swallow or as an injection.
Slovenian: Dvanajst in nato šest ur pred infuzijo boste prejeli deksametazon (steroid) v obliki tablete ali injekcije.
English: If you have a history of heart problems, your heart rate may be monitored.
Slovenian: Če ste kdaj imeli težave s srcem, bodo morda spremljali tudi vaš srčni utrip.
English: Use by:
Slovenian: Uporabno do:
English: Since Paxene contains ethanol, consideration should be given to possible central nervous system and other effects.
Slovenian: Ker vsebuje zdravilo Paxene etanol, je treba upoštevati možnost učinka na osrednji živčni sistem in druge učinke.
English: Minor symptoms such as flushing or skin reactions do not require interruption of therapy.
Slovenian: Blagi simptomi, kot sta rdečica ali kožne reakcije, ne zahtevajo prekinitve zdravljenja.
English: • Balance problems
Slovenian: • težave z ravnotežjem
English: Very rare*: atrial fibrillation
Slovenian: Zelo redki*: atrijska fibrilacija
English: • If you previously had radiation treatment (radiotherapy) to your chest (see section 4: Possible side effects).
Slovenian: • Če so vas zdravili z obsevanjem (radioterapijo) prsnega koša (glejte poglavje 4: Možni neželeni učinki).
English: The exact mechanism of the antitumour activity of paclitaxel is not known.
Slovenian: Natančen mehanizem protitumornega delovanja paklitaksela ni znan.
English: If you are already being treated with doxorubicin for your condition, then your first dose of paclitaxel should be given 24 hours after doxorubicin.
Slovenian: Ce se z doksorubicinom že zdravite zaradi vašega stanja, potem morate prvi odmerek paklitaksela prejeti 24 ur po doksorubicinu.
English: Common: severe elevation in transaminases, severe elevation in alkaline phosphatase
Slovenian: Pogosti: hud dvig vrednosti transaminaz, hud dvig vrednosti alkalne fosfataze
English: Where event incidence differed between Paxene and other paclitaxel clinical studies, the most frequent incidence is presented.
Slovenian: Kadar se pogostost dogodka pri študijah zdravila Paxene in drugih kliničnih študijah paklitaksela razlikuje, je navedena največja pogostost.
English: • Loss of balance or staggering
Slovenian: • izguba ravnotežja ali nestabilnost
English: Further instructions for preparation for infusion
Slovenian: Dodatna navodila za pripravo infuzije
English: In liposomal anthracycline-resistant patients, the response rates were comparable for patients who had never received a protease inhibitor (55.6 %) and those who received one at least 2 months prior to treatment with Paxene (60.9 %).
Slovenian: Pri bolnikih, odpornih proti liposomskim antraciklinom, so bile stopnje odzivnosti primerljive s stopnjami pri tistih bolnikih, ki niso nikoli prejemali proteaznih inhibitorjev (55,6 %), in pri tistih, ki so ga prejeli vsaj dva meseca pred zdravljenjem z zdravilom Paxene (60,9 %).
English: However, paclitaxel belongs to a class of substances which are potentially carcinogenic based on their mechanism of action.
Slovenian: Vendar pa sodi paklitaksel v skupino snovi, ki so zaradi svojega mehanizma delovanja potencialno karcinogene.
English: • Advanced ovarian cancer or remaining tumour (> 1 cm) after initial surgery, in combination with cisplatin as first-line treatment.
Slovenian: • napredovalega karcinoma jajčnikov ali preostalega tumorja (> 1 cm) po začetni operaciji, v kombinaciji s cisplatinom kot zdravljenje prvega izbora
English: Paxene belongs to a group of medicines known as antineoplastic agents.
Slovenian: Zdravilo Paxene sodi v skupino zdravil, znanih kot antineoplastična zdravila.
English: Patients with hepatic impairment may be at increased risk of toxicity, particularly Grade 3-4 myelosuppression.
Slovenian: Bolniki z jetrno okvaro so lahko v nevarnosti za zastrupitev, še posebej v primeru mielosupresije 3.-4. stopnje.
English: There is no evidence that the toxicity of paclitaxel is increased when given as a 3 hour infusion to patients with mildly abnormal liver function.
Slovenian: Ni dokazov o tem, da se toksičnost paklitaksela zveča pri dajanju 3 urne infuzije pri bolnikih z rahlo neobičajno jetrno funkcijo.
English: This may be a sign of a serious bowel inflammation (pseudomembranous colitis).
Slovenian: To je namreč lahko znak resnega vnetja črevesja (psevdomembranski kolitis).
English: Pseudomembranous colitis has been rarely reported including cases in patients who have not been concomitantly treated with antibiotics.
Slovenian: O psevdomembranskem kolitisu so poročali redko, vključno s primeri bolnikov, ki sočasno niso prejemali antibiotikov.
English: Like all medicines, Paxene can cause side effects, although not everybody gets them.
Slovenian: Kot vsa zdravila ima lahko tudi zdravilo Paxene neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
English: This is a tumour that arises from blood vessels in the skin or internal organs and typically appears as flat or raised, purple to dark brown patches on the skin.
Slovenian: To je tumor, ki izvira iz krvnih žil v koži ali notranjih organih in se običajno pojavi kot ploska ali izbočena, temno rdeča do rjava zaplata na koži
English: WHAT PAXENE IS AND WHAT IT IS USED FOR
Slovenian: KAJ JE ZDRAVILO PAXENE IN ZA KAJ GA UPORABLJAMO
English: Safety and efficacy in children and adolescents (under 18 years) has not been established.
Slovenian: Varnost in učinkovitost zdravila pri otrocih in mladostnikih (mlajših od 18 let) ni znana, zato paklitaksela pri teh bolnikih ni priporočljivo uporabljati.
English: It is generally believed that paclitaxel promotes the assembly of microtubules from tubulin dimer and prevents depolymerisation.
Slovenian: V splošnem velja, da pospešuje tvorbo mikrotubulov iz dimerov tubulina in preprečuje njihovo depolimerizacijo.
English: Concurrent administration of ketoconazole, a known potent inhibitor of CYP 3A4, does not inhibit the elimination of paclitaxel in patients; thus, both medicinal products may be administered together without dosage adjustment.
Slovenian: Sočasno dajanje ketokonazola, znanega zaviralca CYP 3A4, pri bolnikih ne zavre eliminacije paklitaksela, zato lahko obe zdravili dajemo sočasno brez prilagoditve odmerka.
English: Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2)
Slovenian: Izdaja zdravila je le pod omejenimi pogoji in na recept (Glejte Dodatek I: Povzetek glavnih značilnosti zdravila, poglavje 4.2)
English: • Effects on the nerves controlling your muscles resulting in weakness in the arms and legs
Slovenian: • učinek na živce, ki nadzirajo mišice, kar povzroči oslabelost rok in nog
English: Other in-use storage times and conditions are the responsibility of the user.
Slovenian: Drugačni časi in pogoji shranjevanja zdravila po prvem odpiranju so odgovornost uporabnika.
English: Animal studies showed non-reversible, toxic effects on the male reproductive organs at clinically relevant exposure levels.
Slovenian: Študije na živalih kažejo pri klinično pomembnih nivojih izpostavljenosti nepovratne toksične učinke zdravila na reproduktivne organe pri moških.
English: If severe peripheral neuropathy occurs the benefit of continued treatment should be weighed against the risks.
Slovenian: Če se pojavi huda periferna nevropatija, je potrebno pretehtati koristi nadaljnjega zdravljenja v primerjavi z možnimi tveganji.
English: • Appearing and acting confused
Slovenian: • zmedena pojava in ravnanje
English: London E16 2QJ United Kingdom
Slovenian: London E16 2QJ Velika Britanija
English: If any problems occur while you are having your infusion, the medical staff will be on hand to take any necessary action.
Slovenian: Če boste med infundiranjem imeli kakšne težave, vam bo za ustrezno ukrepanje na voljo zdravstveno osebje.
English: Dose adjustments during treatment
Slovenian: Prilagoditev odmerjanja med zdravljenjem
English: Paxene may alter the effect of other medicines because of its high alcohol content.
Slovenian: Zdravilo Paxene lahko zaradi velike vsebnosti alkohola spremeni učinek drugih zdravil.
English: Recommendations for handling
Slovenian: Priporočila za rokovanje z zdravilom
English: • Problems with your lungs including swelling and fluid accumulation, which may cause breathing problems
Slovenian: • težave s pljuči, vključni z otekanjem in nabiranjem tekočine, ki lahko povzročijo težave z dihanjem
English: Renal excretion plays a minor role in the elimination of paclitaxel, less than 10 % of the dose has been reported to be excreted in the urine as unchanged drug.
Slovenian: Ekskrecija preko ledvic igra pri izločanju paklitaksela majhno vlogo; poročali so, da se manj kot 10 % odmerka izloči v nespremenjeni obliki z urinom.
English: Median survival for Paxene could not be computed, but the lower 95 % bound was 617 days in core patients.
Slovenian: Srednje vrednosti preživetja pri uporabi zdravila Paxene ni bilo mogoče določiti, sicer pa je bila pri glavni skupini bolnikov spodnja meja 95-odstotna, torej 617 dni.
English: Except for haematological and hepatic events (see below), generally the frequency and severity of undesirable effects in AIDS-KS patients were similar to those noted in patients with other solid tumours treated with paclitaxel monotherapy.
Slovenian: Razen hematoloških učinkov in učinkov na jetra (glejte spodaj), sta bili pogostost in resnost neželenih učinkov pri bolnikih z AIDS-KS podobni kot pri bolnikih z drugimi trdnimi tumorji, ki so jih samostojno zdravili s paklitakselom.
English: You will only be given your infusion under medical supervision, and you will be checked regularly while you are having your infusion to see how you are reacting to it.
Slovenian: Infuzijo boste prejeli pod zdravniškim nadzorom, kjer bodo med infundiranjem redno preverjali, kako se odzivate na zdravljenje.
English: If you feel unwell between courses or after your treatment has finished, tell your doctor or pharmacist as soon as you can.
Slovenian: Če se slabo počutite med dvema cikloma zdravljenja ali po koncu zdravljenja, o tem čimprej obvestite svojega zdravnika ali farmacevta.
English: • Before you start treatment with Paxene and during treatment, you will have regular blood tests to check that it is safe for you to continue with your treatment.
Slovenian: • Pred začetkom zdravljenja z zdravilom Paxene in med zdravljenjem vam bodo redno pregledovali kri, da bi ugotovili, ali je nadaljevanje zdravljenja za vas varno.
English: The efficacy and safety of Paxene were investigated in a single, non-comparative study in 107 patients with advanced KS, previously treated with systemic chemotherapy.
Slovenian: Učinkovitost in varnost zdravila Paxene so raziskovali v eni sami, neprimerjalni študiji na 107 bolnikih z napredovalim Kaposijevim sarkomom, ki so se prej zdravili s sistemsko kemoterapijo.
English: Anaemia (Hb< 11 g/dl) was observed in approximately 9 % of treated patients but was severe in less than 1 % (Hb< 8 g/dl).
Slovenian: Anemijo (Hb < 11 g/dl) so opazili pri približno 9 % zdravljenih bolnikov, vendar je bila pri manj kot 1 % (Hb < 8 g/dl) huda.
English: Paxene concentrate for solution for infusion is used to treat:
Slovenian: Zdravilo Paxene koncentrat za raztopino za infundiranje se uporablja za zdravljenje:
English: • Low blood platelet counts that can cause unusual bleeding (e.g. nose bleeds) and unexplained bruising
Slovenian: • nizka raven trombocitov, ki lahko povzroči neobičajno krvavitev (npr. krvavitev iz nosu) in nerazložljive modrice
English: As Paxene contains ethanol (392 mg/ml), possible effects on the CNS and other effects should be considered (see section 4.7).
Slovenian: Zdravilo Paxene vsebuje etanol (392 mg/ml), zato je treba upoštevati morebitne učinke na osrednje živčevje in druge učinke (glejte poglavje 4.7).
English: Paxene solutions should be prepared and stored in glass, polypropylene, or polyolefin containers.
Slovenian: Raztopine zdravila Paxene je potrebno pripraviti in shranjevati v vsebnikih iz stekla, polipropilena ali poliolefina.
English: Clearance was 20.6 l/h/m2 (range 11 - 38) and the volume of distribution was 291 l/m2 (range 121 - 638).
Slovenian: Očistek je bil 20,6 l/h/m2 (v intervalu 11 - 38), volumen porazdelitve pa 291 l/m2 (v intervalu 121 - 638).
English: Paclitaxel at low doses of 0.6 mg/kg/day was associated with low fertility and foetal toxicity in rats.
Slovenian: Pri podganah je bil paklitaksel pri nizkih odmerkih 0,6 mg/kg/dan povezan z zmanjšano plodnostjo in pojavom toksičnosti pri plodu.
English: Paxene might also leak from the vein and cause an infection or ulceration of the surrounding skin.
Slovenian: Zdravilo Paxene lahko izteka tudi iz vene in povzroči okužbo in razjede okoliške kože.
English: Paxene is indicated for the treatment of patients with: - advanced AIDS-related Kaposi's sarcoma (AIDS-KS) who have failed prior liposomal anthracycline therapy; - metastatic carcinoma of the breast (MBC) who have failed, or are not candidates for standard anthracycline-containing therapy; - advanced carcinoma of the ovary (AOC) or with residual disease (> 1 cm) after initial laparotomy, in combination with cisplatin as first-line treatment; - metastatic carcinoma of the ovary (MOC) after failure of platinum-containing combination therapy without taxanes as second-line treatment; - non-small cell lung carcinoma (NSCLC) who are not candidates for potentially curative surgery and/or radiation therapy, in combination with cisplatin.
Slovenian: Zdravilo Paxene je indicirano za zdravljenje bolnikov z: - napredovalim Kaposijevim sarkomom, povezanim z AIDS (AIDS-KS), pri katerih je bilo predhodno zdravljenje z antraciklini v obliki liposomov neuspešno, - metastatskim karcinomom dojke (metastatic breast cancer - MBC), pri katerih je bilo standardno zdravljenje z antraciklini neuspešno ali pa tovrstno zdravljenje za njih ni primerno, - napredovalim karcinomom jajčnikov (advanced carcinoma of the ovary - AOC) ali z rezidualno boleznijo (> 1 cm) po prvotni lapratomiji, v kombinaciji s cisplatinom kot zdravljenje prvega izbora, - metastatskim karcinomom jajčnika (metastatic ovarian cancer - MOC) po neuspešnem kombiniranem zdravljenju s platino, ki ne vključuje taksanov zdravljenje drugega izbora, - nedrobnoceličnim karcinomom pljuč (non-small cell lung carcinoma - NSCLC), ki niso kandidati za potencialno zdravilni operacijski poseg in/ali zdravljenje z obsevanjem, v kombinaciji s cisplatinom.
English: Handling and disposal
Slovenian: Ravnanje in odlaganje
English: • Severe chest pains, irregular heart beat, feeling faint and heart attack
Slovenian: • hude bolečine v prsih, nepravilen srčni ritem, občutek omedlevanja in srčni napad
English: 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), not known (cannot be estimated from the available data).
Slovenian: Zelo pogosti (≥ 1/10); pogosti (≥ 1/100, < 1/10); občasni (≥ 1/1 000, < 1/100); redki (≥ 1/10 000, < 1/1 000); zelo redki (< 1/10 000), vključno s posameznimi primeri.
English: When administered as part of a combination regimen with cisplatin, it is recommended that Paxene is given before cisplatin.
Slovenian: Kadar ga uporabljamo kot del kombiniranega zdravljenja s cisplatinom, je priporočeno zdravilo Paxene dajati pred cisplatinom.
English: However, the higher response rates (37 % vs. 26 %), lesser overall side effects and improved short term QoL with cisplatin/paclitaxel vs cisplatin/tenoposide were considered important results in a palliative population.
Slovenian: Vendar so večja stopnja odzivnosti (37 % v primerjavi s 26 %), manjši skupni neželeni učinki in izboljšana kratkoročna kakovost življenja pri cisplatinu/paklitakselu kot pri cisplatinu/tenopozidu pomembni rezultati pri paliativni populaciji.
English: Studies conducted in AIDS-KS patients who were taking Paxene and multiple concomitant medicinal products suggest that the systemic clearance of paclitaxel was significantly lower (p < 0.05) in the presence of nelfinavir and ritonavir, but not with indinavir.
Slovenian: Študije, izvedene pri bolnikih z AIDS-KS, ki so sočasno prejemali zdravilo Paxene in več drugih zdravil, kažejo, da je sistemski očistek paklitaksela značilno nižji (p < 0,05) ob prisotnosti nelfinavirja in ritonavirja ne pa ob prisotnosti indinavirja.
English: • Advanced non-small cell lung cancer if potentially curative surgery and/or radiation therapy are not possible, in combination with cisplatin.
Slovenian: • nedrobnoceličnim rakom pljuč, če potencialno zdravilni operacijski poseg in/ali zdravljenje z obsevanjem v kombinaciji s cisplatinom ni možno.
English: However, severe reactions, such as hypotension requiring treatment, dyspnoea requiring bronchodilators, angio-oedema or generalised urticaria require immediate discontinuation of paclitaxel and aggressive symptomatic therapy.
Slovenian: V primerih hudih reakcij, kot so hipotenzija, ki zahteva zdravljenje, dispneja, pri kateri so potrebni bronhodilatatorji, angioedem ali generalizirana urtikarija, pa je potrebno zdravljenje s paklitakselom takoj prekiniti in začeti z agresivnim simptomatskim zdravljenjem.
English: Pneumonitis in patients receiving concomitant radiotherapy and/or gemcitabine has been reported very rarely.
Slovenian: O pnevmonitisu so pri bolnikih, ki so prejemali sočasno zdravljenje z obsevanjem in/ali gemcitabinom, poročali zelo redko.
English: No data are available for patients with severe baseline cholestasis.
Slovenian: Ni podatkov o bolnikih s hudo osnovno holestazo.
English: MANUFACTURER'S BATCH NUMBER Batch Number:
Slovenian: IZDELOVALČEVA ŠTEVILKA SERIJE IZDELAVE ZDRAVILA Serija:
English: • Infections - this may be associated with feeling hot (fever) or cold (chills), sore throat and fungal infection in the mouth (oral candidiasis)
Slovenian: • okužbe - povezane so lahko z vročicami (zvišano telesno temperaturo) ali mrzlicami (hladnim oblivanjem), vnetim grlom in glivičnimi okužbami v ustih (ustna kandidiaza)
English: Neutropenic fever related to Paxene was reported in 14 % of patients.
Slovenian: O nevtropenični mrzlici, povezani z zdravilom Paxene, so poročali pri 14 % bolnikov.
English: • Injection site reactions leading to pain, swelling and hardness of the skin around the injection site.
Slovenian: • reakcije na mestu injiciranja, ki povzročilo bolečino, oteklost in otrdelost kože okoli mesta injiciranja.
English: Uncommon: severe elevation in bilirubin * As reported in post-marketing surveillance of paclitaxel.
Slovenian: Občasni: hud dvig vrednosti bilirubina * Kot izhaja iz poročil po začetku trženja paklitaksela.
English: Recurrence of skin reactions at a site of previous extravasation following administration of paclitaxel at a different site i.e. “recall” has been reported rarely.
Slovenian: Redko so poročali o ponovni reakciji kože na mestu prejšnje ekstravazacije po uporabi paklitaksela na drugem mestu, tako imenovani “recall”.
English: Neuropathy, primarily peripheral sensory neuropathy, occurs very commonly and is usually of mild to moderate intensity.
Slovenian: Nevropatija, največkrat periferna senzorična nevropatija, se pojavlja zelo pogosto in je ponavadi blaga do zmerna.
English: Uncommon: dry eyes, amblyopia, visual field defect Very rare*: optic nerve and/or visual disturbances (scintillating scotoma), particularly in patients who have received higher doses than recommended
Slovenian: Občasni: suhe oči in ambliopija, okvare vidnega polja Zelo redki*: motnje optičnega živca in/ali vida (scotoma scintilans), zlasti pri bolnikih, ki so prejeli višje odmerke od priporočenih.
English: Very rare*: anaphylactic shock (including fatal hypersensitivity)
Slovenian: Zelo redki*: anafilaktični šok (vključno z usodno preobčutljivostjo)
English: Although the two different paclitaxel posologies were not compared with each other directly, in both trials patients treated with paclitaxel in combination with cisplatin had a significantly longer time to progression (Study 1: median 15.3 months vs 11.5 months, p< 0.001; Study 2: median 17 months vs 13 months, p< 0.001), and longer survival time (Study 1: median 36 months vs 26 months, p= 0.0016; Study 2: median 36 months vs 24 months, p< 0.001), and in Study 1 a significantly higher response rate (Study 1: 59 % vs 45 %, p= 0.014; Study 2: 60 % vs 50 %, NS), when compared with standard therapy.
Slovenian: Čeprav teh dveh odmerjanj paklitaksela niso neposredno primerjali med seboj, je bil pri obeh preskušanjih pri bolnikih, ki so jih zdravili s paklitakselom v kombinaciji s cisplatinom, čas do progresije daljši (študija 1: mediana 15,3 meseca v primerjavi z 11,5 meseca, p < 0,001; študija 2: mediana 17 mesecev v primerjavi s 13 meseci, p < 0,001), in obdobje preživetja je bilo daljše (študija 1: mediana 36 mesecev v primerjavi s 26 meseci, p = 0,0016; študija 2: mediana 36 mesecev v primerjavi s 24 meseci, p < 0,001), v študiji 1 pa je bila stopnja odzivnosti značilno večja (študija 1: 59 % v primerjavi 45 %, p = 0,014; študija 2: 60 % v primerjavi s 50 %, NS) v primerjavi s standardnim zdravljenjem.
English: Please tell your doctor before you are given Paxene if you:
Slovenian: Prosimo, da predno boste prejeli zdravilo Paxene, svojemu zdravniku poveste, če:
English: • Low blood pressure, which may make you feel light-headed upon standing
Slovenian: • nizek krvni pritisk, ki povzroči občutek prazne glave po vstajanju
English: Paxene should be administered through an in-line filter with a microporous membrane not greater than 0.22 µm.
Slovenian: Zdravilo Paxene je potrebno dajati preko v sistem vgrajenega filtra z membrano z mikroporami, ki niso večje od 0,22 µm.
English: Contact of the undiluted concentrate with plasticised PVC equipment or devices used to prepare solutions for infusion is not recommended.
Slovenian: Stik med nerazredčenim koncentratom in plastično PVC opremo ali pripomočki, ki se uporabljajo za pripravo raztopin za infundiranje, ni priporočljiv.
English: Paxene should only be administered under the supervision of a qualified oncologist in units specialised in the administration of cytotoxic agents (see section 6.6).
Slovenian: Zdravilo Paxene se lahko uporablja samo pod nadzorom usposobljenega onkologa na oddelkih, ki so specializirani za aplikacijo citotoksičnih snovi (glejte poglavje 6.6).
English: Cardiac monitoring is not recommended except in patients with serious conduction abnormalities or arrhythmias.
Slovenian: Nadzorovanje delovanja srca ni potrebno, razen pri bolnikih s hudimi motnjami prevodnosti ali z aritmijo.
English: • Life-threatening allergic reaction (anaphylactic shock)
Slovenian: • življenjsko nevarna alergijska reakcija (anafilaktični šok)
English: 6.6 Instructions for use, handling and disposal For single use only.
Slovenian: 6.6 Navodila za pripravo, ravnanje in odlaganja zdravila
English: Do not use Paxene after the expiry date, which is stated on the vial label and outer carton after “use by”.
Slovenian: Zdravila Paxene ne smete uporabljati po izteku datuma uporabnosti, I je naveden na oznaki viale in škatli poleg oznake „uporabno do“.
English: Very rare*: Stevens-Johnson syndrome, epidermal necrolysis, erythema multiforme, urticaria, onycholysis (patients on therapy should wear sun protection on hands and
Slovenian: Zelo redki*: Stevens-Johnsonov sindrom, epidermalna nekroliza, erythema multiforme, urtikarija, oniholiza (bolniki, ki se zdravijo, morajo na rokah in stopalih nositi zaščito proti soncu)
English: Appropriate supportive medicinal products should be readily available in case of severe hypersensitivity reactions.
Slovenian: Ustrezna oprema za podporno zdravljenje mora biti vedno na voljo za primere hudih preobčutljivostnih reakcij.
English: Studies in patients with impaired renal function have not been performed and there are insufficient data to permit dose recommendations (see section 5.2).
Slovenian: Študije na bolnikih z zmanjšano ledvično funkcijo niso bile izvedene; na voljo ni dovolj podatkov za priporočila glede odmerjanja (glejte poglavje 5.2).