FrancophonIA/ELRC3.0 huggingface dataset:
English: Adverse reactions reported in all CML and Ph+ ALL patients are presented in Table 4.
Slovenian: Neželeni učinki, o katerih so poročali za vse bolnike s KML in Ph+ ALL, so predstavljeni v preglednici 4.
English: amylase alkaline phosphatase gamma-glutamyltransferase
Slovenian: - gama-glutamiltransferaze
English: Arterial occlusions, including fatal myocardial infarction, stroke, retinal arterial occlusions associated in some cases with permanent visual impairment or vision loss, stenosis of large arterial vessels of the brain, severe peripheral vascular disease, renal artery stenosis (associated with worsening, labile or treatment-resistant hypertension), and the need for urgent revascularization procedures have occurred in Iclusig-treated patients.
Slovenian: Pri bolnikih, zdravljenih z zdravilom Iclusig, so se pojavili arterijska okluzija, vključno s smrtnim miokardnim infarktom, možgansko kapjo, retinalna arterijska okluzija, v nekaterih primerih povezana s trajno okvaro vida ali slepoto, stenozo velikih arterijskih žil v možganih, hudo periferno žilno boleznijo, stenozo ledvične arterije (povezano s poslabšanjem hipertenzije, labilno hipertenzijo ali na zdravljenje odporno hipertenzijo) in potrebo po nujnem postopku revaskularizacije.
English: Table 8 Efficacy of Iclusig in resistant or intolerant advanced phase CML patients Accelerated Phase CML
Slovenian: Preglednica 8 Učinkovitost zdravila Iclusig pri bolnikih s KML z napredovalo fazo, ki so na zdravljenje odporni ali ga ne prenašajo KML v pospešeni fazi
English: • you have a liver disorder.
Slovenian: • imate motnje v delovanju jeter.
English: Co-administration of a single 15 mg oral dose of Iclusig in the presence of ketoconazole (400 mg daily), a strong CYP3A inhibitor, resulted in modest increases in ponatinib systemic exposure, with ponatinib AUC0-∞ and Cmax values that were 78% and 47% higher, respectively, than those seen when ponatinib was administered alone.
Slovenian: Sočasna uporaba enega 15 mg peroralnega odmerka zdravila Iclusig v prisotnosti ketokonazola (400 mg na dan), močnega zaviralca CYP3A, je povzročila blago zvišanje sistemske izpostavljenosti ponatinibu, z vrednostima AUC0-∞ in Cmax, ki sta bili za 78 % oz. 47 % višji kot pri dajanju samega ponatiniba.
English: (95% CI) a Primary endpoint for AP-CML and BP-CML/Ph+ ALL Cohorts was MaHR, which combines complete haematological responses and no evidence of leukaemia.
Slovenian: (95-% IZ) a Primarni opazovani dogodek za kohorti AP-KML in BP-KML/Ph+ ALL je bil MaHR, ki združuje celovit hematološki odgovor in odsotnost dokazov o levkemiji.
English: • chronic phase, accelerated phase, or blast phase chronic myeloid leukaemia (CML) who are resistant to dasatinib or nilotinib; who are intolerant to dasatinib or nilotinib and for whom subsequent treatment with imatinib is not clinically appropriate; or who have the T315I mutation
Slovenian: • s kronično mieloidno levkemijo (KML) v kronični fazi, pospešeni fazi ali blastni fazi, ki so odporni na dasatinib ali nilotinib; ki ne prenašajo dasatiniba ali nilotiniba in pri katerih nadaljnje zdravljenje z imatinibom ni klinično ustrezno; ali ki imajo mutacijo T315I
English: Iclusig is available in plastic bottles, each containing one canister of a molecular sieve desiccant.
Slovenian: Zdravilo Iclusig je na voljo v plastenkah, od katerih vsaka vsebuje eno posodo s sušilnim sredstvom z molekulskim sitom.
English: The secondary efficacy endpoints in CP-CML were complete haematological response (CHR) and major molecular response (MMR).
Slovenian: Sekundarni opazovani dogodek učinkovitosti pri bolnikih s CP-KML je bil celovit hematološki odgovor (CHR, complete haematological response) in bistven molekularni odgovor (MMR, major molecular response).
English: The incidence of severe bleeding events was higher in patients with AP-CML, BP-CML and Ph+ ALL.
Slovenian: Incidenca težkih krvavitev je bila večja pri bolnikih z AP-KML, BP-KML in Ph+ ALL.
English: Occurrence at 30 mg:
Slovenian: Pojav pri 30 mg:
English: Arterial occlusive adverse events were more frequent with increasing age and in patients with history of ischaemia, hypertension, diabetes, or hyperlipidaemia.
Slovenian: Neželeni učinki arterijske okluzije so bili pogostejši pri starejših bolnikih in pri bolnikih z ishemijo, hipertenzijo, sladkorno boleznijo ali hiperlipidemijo v anamnezi.
English: Serious venous occlusive reactions (treatment-emergent frequencies) occurred in 5% of patients.
Slovenian: Resne venske okluzivne reakcije (pogostnosti v povezavi z zdravljenjem) so se pojavile pri 5 % bolnikov.
English: • pain in bones, joints, pain in muscles, back, arms or legs, muscle spasms
Slovenian: • bolečina v kosteh, sklepih, bolečina v mišicah, hrbtu, rokah ali nogah, mišični krči
English: Resistant or Intolerant R/I Cohort (N=203)
Slovenian: Odporni ali ne prenašajo O/N kohorta (N = 203)
English: • Philadelphia chromosome positive acute lymphoblastic leukaemia (Ph+ ALL) who are resistant to dasatinib; who are intolerant to dasatinib and for whom subsequent treatment with imatinib is not clinically appropriate; or who have the T315I mutation.
Slovenian: • z akutno limfoblastno levkemijo s prisotnim kromosomom Philadelphia (Ph+ ALL), ki so odporni na dasatinib; ki ne prenašajo dasatiniba in pri katerih nadaljnje zdravljenje z imatinibom ni klinično ustrezno; ali ki imajo mutacijo T315I.
English: In the phase 2 trial (with a minimum of 64 months follow-up), venous thromboembolic adverse reactions have occurred in 6% of patients (treatment-emergent frequencies).
Slovenian: V preskušanju 2. faze (z najmanj 64 mesecev spremljanja), so se venski trombembolični neželeni učinki pojavili pri 6 % bolnikov (pogostnosti v povezavi z zdravljenjem).
English: • stroke (symptoms include: difficulty to speak or move, sleepiness, migraine, abnormal sensations)
Slovenian: • možganska kap (simptomi vključujejo težave z govorom ali premikanjem, zaspanost, migreno,
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Iclusig 15 mg film-coated tablets
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA Iclusig 15 mg filmsko obložene tablete
English: Venous thromboembolic reactions (treatment-emergent frequencies) occurred in 6% of patients.
Slovenian: Venski trombembolični dogodki (pogostnosti v povezavi z zdravljenjem) so se pojavili pri 6 % bolnikov.
English: In the phase 2 trial (with a minimum of 64 months follow-up), arterial occlusive adverse reactions have occurred in 25% of patients (treatment-emergent frequencies).
Slovenian: V preskušanju 2. faze (z najmanj 64 mesecev spremljanja) so se arterijski okluzivni neželeni učinki pojavili pri 25 % bolnikov (pogostnosti v povezavi z zdravljenjem).
English: • sodium decrease in the blood
Slovenian: • znižanje ravni natrija v krvi
English: • lung infection (may cause breathing difficulty)
Slovenian: • okužba pljuč (lahko povzroči težave z dihanjem)
English: • renal artery stenosis (narrowing of the blood vessels to one or both kidneys)
Slovenian: • stenoza ledvične arterije (zožitev krvnih žil do ene ali obeh ledvic)
English: Severe skin reactions (such as Stevens-Johnson Syndrome) have been reported with some BCR-ABL Tyrosine Kinase Inhibitors.
Slovenian: Hudi neželeni učinki na koži (SCARs - severe cutaneous adverse reactions) Pri nekaterih zaviralcih tirozin-kinaze BCR-ABL so poročali o hudih učinkih na koži (kot je Stevens-Johnsonov sindrom).
English: • blurred vision, dry eye, infection in the eye, visual disturbance
Slovenian: • zamegljen vid, suhe oči, vnetje oči, motnje vida
English: Iclusig should be continued at the same dose
Slovenian: Nadaljevati je treba z enakim odmerkom zdravila Iclusig.
English: Unchanged ponatinib accounted for 24% and < 1% of the administered dose in faeces and urine, respectively, with the remainder of the dose comprising metabolites.
Slovenian: V blatu je bilo 24 % nespremenjenega uporabljenega ponatiniba in v urinu < 1 %, preostali odmerek pa so predstavljali presnovki.
English: Treatment-emergent hypertension (including hypertensive crisis) occurred in Iclusig-treated patients.
Slovenian: Pri bolnikih, zdravljenih z zdravilom Iclusig, se je pojavila z zdravljenjem povezana hipertenzija (vključno s hipertenzivno krizo).
English: The clinical relevance of this finding for humans is not known.
Slovenian: Klinični pomen te ugotovitve za človeka ni znan.
English: The frequency of these events is greater in patients with accelerated phase CML (AP-CML) or blast phase CML (BP-CML)/Ph+ ALL than in chronic phase CML (CP-CML).
Slovenian: Pogostnost teh dogodkov je večja pri bolnikih s KML v pospešeni fazi (AP-KML) ali KML v blastni fazi (BP-KML)/Ph+ ALL, kot pri bolnikih s KML v kronični fazi (CP-KML).
English: Arterial cardiovascular, cerebrovascular, and peripheral vascular occlusive adverse reactions (treatment-emergent frequencies) occurred in 13%, 9%, and 11% of Iclusig-treated patients, respectively.
Slovenian: Arterijski kardiovaskularni, cerebrovaskularni in periferni vaskularni okluzivni neželeni učinki (pogostnosti v povezavi z zdravljenjem) so se pojavili pri 13 %, 9 % oz. 11 % bolnikov, zdravljenih z zdravilom Iclusig.
English: The risk of arterial occlusive events is likely to be dose-related (see sections 4.2 and 5.1).
Slovenian: Tveganje arterijskih okluzivnih dogodkov je verjetno povezano z odmerkom (glejte poglavji 4.2 in
English: Occurrence at 15 mg:
Slovenian: Pojav pri 15 mg:
English: Post-marketing cases of Posterior Reversible Encephalopathy Syndrome (PRES) have been reported in Iclusig-treated patients.
Slovenian: Pri bolnikih, zdravljenih z zdravilom Iclusig, so po prihodu zdravila na trg poročali o primerih sindroma posteriorne reverzibilne encefalopatije (PRES - Posterior Reversible Encephalopathy Syndrome).
English: Bottles of Iclusig 30 mg contain 30 film-coated tablets.
Slovenian: Plastenke zdravila Iclusig 30 mg vsebujejo 30 filmsko obloženih tablet.
English: The frequency of Grade 3 or 4 thrombocytopenia, neutropenia, and anaemia was higher in patients with AP-CML and BPCML/Ph+ ALL than in patients with CP-CML (see Table 5).
Slovenian: Pogostnost trombocitopenije, nevtropenije in anemije 3. ali 4. stopnje je bila pogostejša pri bolnikih z AP-KML in BP-KML/Ph+ ALL, kot pri bolnikih s CP-KML (glejte preglednico 5).
English: Iclusig 15 mg film-coated tablets Iclusig 30 mg film-coated tablets Iclusig 45 mg film-coated tablets ponatinib
Slovenian: Iclusig 15 mg filmsko obložene tablete Iclusig 30 mg filmsko obložene tablete Iclusig 45 mg filmsko obložene tablete ponatinib
English: Dose modifications for neutropenia (ANC* < 1.0 x 109/L) and thrombocytopenia (platelet < 50 x 109/L) that are unrelated to leukaemia are summarized in Table 1.
Slovenian: trombociti < 50 x 109/l), ki nista povezani z levkemijo, je povzeto v preglednici 1.
English: Ponatinib is a potent pan BCR-ABL inhibitor with structural elements, including a carbon-carbon triple-bond, that enable high affinity binding to native BCR-ABL and mutant forms of the ABL kinase.
Slovenian: Ponatinib je močan zaviralec pan-BCR-ABL s strukturnimi elementi, vključno s trojno vezjo ogljik-ogljik, ki omogočajo visoko afiniteto vezave na nativni BCR-ABL in mutirane oblike kinaze ABL. Ponatinib zavira aktivnost tirozin-kinaze ABL in mutanta ABL T315I z vrednostmi IC50 0,4 oz. 2,0 nM.
English: Monitoring for evidence of arterial occlusion should be performed and if decreased vision or blurred vision occurs, an ophthalmic examination (including fundoscopy) should be performed.
Slovenian: Spremljati je treba znake arterijske okluzije in, če se pojavi poslabšanje vida ali zamegljen vid, je treba opraviti oftalmološki pregled (vključno s fundoskopijo), Zdravljenje z zdravilom Iclusig takoj prekiniti, če se pojavi arterijska okluzija.
English: A majority of these ongoing patients (82/110 patients; 75%) were reported to be receiving 15 mg at the last dose, while 24/110 patients (22%) were receiving 30 mg, and 4/110 (4%) were receiving 45 mg. At the time of study closure initiation (minimum follow-up of 64 months, and more than 3 years after the recommendation for prospective dose reduction), 99 CP-CML patients were ongoing and 77 (78%) of these patients received 15 mg as their last dose on study.
Slovenian: Večina teh bolnikov (82/110 bolnikov; 75 %) je prejemalo 15 mg pri zadnjem odmerku, medtem ko je 24/110 bolnikov (22 %) prejemalo 30 mg in 4/110 (4 %) 45 mg.
English: • upper airway infection (may cause breathing difficulty)
Slovenian: • okužba zgornjih dihal (lahko povzroči težave z dihanjem)
English: Total safety population N=449
Slovenian: N = 449
English: The clinical relevance of these findings on human fertility is unknown.
Slovenian: Klinična pomembnost teh ugotovitev za plodnost pri človeku ni znana.
English: • rash, dry skin, itching
Slovenian: • izpuščaj, suha koža, srbenje
English: Serious arterial cardiovascular, cerebrovascular, and peripheral vascular occlusive adverse reactions (treatment-emergent frequencies) occurred in 10%, 7%, and 9% of Iclusig treated patients, respectively (see section 4.8).
Slovenian: Resni arterijski kardiovaskularni, cerebrovaskularni in periferni vaskularni okluzivni neželeni učinki (pogostnosti v povezavi z zdravljenjem) so se pojavili pri 10 %, 7 % oz. 9 % bolnikov, zdravljenih z zdravilom Iclusig (glejte poglavje 4.8).
English: The primary efficacy endpoint in CP-CML was major cytogenetic response (MCyR), which included complete and partial cytogenetic responses (CCyR and PCyR).
Slovenian: Primarni opazovani dogodek učinkovitosti pri bolnikih s CP-KML je bil bistven citogenetski odgovor (MCyR, major cytogenetic response), ki je vključeval celovit (CCyR, complete cytogenetic response)
English: Reducing the dose of Iclusig to 15 mg should be considered for CP-CML patients who have achieved a major cytogenetic response taking the following factors into account in the individual patient assessment: cardiovascular risk, side effects of ponatinib therapy, time to cytogenetic response, and BCR-ABL transcript levels (see sections 4.4 and 5.1).
Slovenian: Pri teh bolnikih je treba pri oceni koristi in tveganj za posameznika upoštevati naslednje dejavnike: kardiovaskularno tveganje, neželene učinke zdravljenja s ponatinibom, čas do citogenetskega odgovora in ravni transkriptov BCR-ABL (glejte poglavji 4.4 in 5.1).
English: The incidence of thromboembolic events is higher in patients with Ph+ ALL or BP-CML than those with AP-CML or CP-CML.
Slovenian: Pojavnost trombemboličnih dogodkov je višja pri bolnikih s Ph + ALL ali BP-KML kot pri bolnikih z AP-KML ali CP-KML.
English: Iclusig 30 mg film-coated tablets are approximately 8 mm in diameter with "C7" on one side.
Slovenian: Zdravilo Iclusig 30 mg filmsko obložene tablete imajo v premeru približno 8 mm in vtisnjeno oznako "C7" na eni strani.
English: Iclusig 45 mg film-coated tablets EU/1/13/839/003
Slovenian: Iclusig 45 mg filmsko obložene tablete EU/1/13/839/003
English: Cohort (N=65)
Slovenian: O/N kohorta (N = 65)
English: Discontinuation of ponatinib should be considered in patients who develop serious heart failure (see sections 4.2 and 4.8).
Slovenian: Pri bolnikih, pri katerih se razvije resno srčno popuščanje, je treba razmisliti o ukinitvi ponatiniba (glejte poglavji 4.2 in 4.8).
English: The bottle contains one sealed plastic canister containing a molecular sieve desiccant.
Slovenian: Plastenka vsebuje eno zaprto plastično posodo s sušilnim sredstvom, ki vsebuje molekulsko sito.
English: • a history of renal artery stenosis (narrowing of the blood vessels to one or both kidneys)
Slovenian: • stenozo ledvične arterije v zdravstveni zgodovini (zožitev krvnih žil do ene ali obeh ledvic)
English: Table 9 Efficacy of Iclusig in resistant or intolerant Ph+ ALL patients Overall (N=32)
Slovenian: Preglednica 9 Učinkovitost zdravila Iclusig pri bolnikih Ph+ ALL, ki so na zdravljenje odporni ali ga ne prenašajo
English: At the time of updated reporting with minimum follow-up for all ongoing patients of 64 months, the median duration of MaHR for AP-CML (median duration of treatment: 19.4 months) BP-CML (median duration of treatment: 2.9 months), and Ph+ ALL (median duration of treatment: 2.7 months) patients was estimated as 12.9 months (range: 1.2 to 68.4 months), 6.0 months (range: 1.8 to 59.6 months), and 3.2 months (range: 1.8 to 12.8 months), respectively.
Slovenian: 19,4 meseca) ocenjena na 12,9 mesecev (razpon: 1,2 do 68,4 meseca), za bolnike z BP-KML (mediana trajanja zdravljenja: 2,9 meseca) na 6,0 mesecev (razpon: 1,8 do 59,6 meseca) in za bolnike s Ph+ ALL (mediana trajanja zdravljenja: 2,7 meseca) na 3,2 meseca (razpon: 1,8 do 12,8 meseca).
English: Iclusig 15 mg film-coated tablets EU/1/13/839/001
Slovenian: Iclusig 15 mg filmsko obložene tablete EU/1/13/839/001
English: Serious arterial cardiovascular, cerebrovascular, and peripheral vascular occlusive adverse reactions (treatment-emergent frequencies) occurred in 10%, 7%, and 9% of Iclusig treated patients, respectively.
Slovenian: Resni arterijski kardiovaskularni, cerebrovaskularni in periferni vaskularni okluzivni neželeni učinki (pogostnosti v povezavi z zdravljenjem) so se pojavili pri 10 %, 7 % oz. 9 % bolnikov, zdravljenih z zdravilom Iclusig.
English: Iclusig 30 mg film-coated tablets EU/1/13/839/006
Slovenian: Iclusig 30 mg filmsko obložene tablete EU/1/13/839/006
English: • the number of blood platelets is reduced.
Slovenian: • se število trombocitov zmanjša;
English: Iclusig should be discontinued *IULN = institution upper limit of normal Hepatic toxicity
Slovenian: *IULN = zgornja meja normalnih vrednosti, specifična za ustanovo (institutional upper limit of normal)
English: Experts in liver disease and in the treatment of hepatitis B should be consulted before treatment is initiated in patients with positive hepatitis B serology (including those with active disease) and for patients who test positive for HBV infection during treatment.
Slovenian: Bolnike je treba pred začetkom zdravljenja z zdravilom Iclusig testirati glede okužbe z virusom hepatitisa B. Pri bolnikih s pozitivno serologijo na hepatitis B (vključno z bolniki z aktivno boleznijo) in bolnikih, pri katerih se med zdravljenjem test glede okužbe z virusom hepatitisa B izkaže za pozitivnega, se je treba pred začetkom zdravljenja posvetovati s strokovnjaki za obolenja jeter in zdravljenje hepatitisa B. Pri prenašalcih virusa hepatitisa B, pri katerih je potrebno zdravljenje z zdravilom Iclusig, je treba med zdravljenjem in nekaj mesecev po njegovem zaključku skrbno spremljati pojav znakov in simptomov aktivne okužbe z virusom hepatitisa B (glej poglavje 4.8).
English: • sulfasalazine: a medicine to treat severe bowel and rheumatic joint inflammation.
Slovenian: • sulfasalazin: zdravilo za zdravljenje hudega vnetja črevesja ali revmatičnega vnetja sklepov Zdravilo Iclusig skupaj s hrano in pijačo
English: • obstruction of the blood vessels in the eye
Slovenian: • zapora krvnih žil v očesu
English: • Iclusig should be resumed at 30 mg after recovery to ≤ Grade 1 (< 3 × ULN), or recovery to pre-treatment grade Occurrence at 30 mg:
Slovenian: • Z jemanjem zdravila Iclusig 30 mg je treba nadaljevati po vrnitvi na ≤ stopnje 1 (< 3 × ULN) ali vrnitvi na stopnjo pred zdravljenjem.
English: Retinal venous occlusions associated in some cases with permanent visual impairment or vision loss have occurred in Iclusig-treated patients.
Slovenian: Pri nekaterih bolnikih zdravljenih z zdravilom Iclusig so se pojavile venske okluzije mrežnice, ki so v nekaterih primerih povezane s stalno izgubo vida ali slabovidnostjo.
English: • skin rash, peeling of the skin, abnormal thickening of the skin, redness, bruising, skin pain,
Slovenian: • kožni izpuščaj, luščenje kože, nenormalno zadebeljena koža, rdečina kože, podplutost, boleča koža, spremenjena barva kože, izpadanje las
English: • headache, confusion, seizures, and loss of vision, which may be symptoms of a brain condition known as posterior reversible encephalopathy syndrome (PRES).
Slovenian: • glavobol, zmedenost, epileptični napadi in izguba vida so lahko simptomi stanja možganov,
English: Common cardiac failure, myocardial infarction, cardiac failure congestive, coronary artery disease, angina pectoris, pericardial effusion, atrial fibrillation, ejection fraction decreased, acute coronary syndrome, atrial flutter
Slovenian: Srčne bolezni pogosti srčno popuščanje, miokardni infarkt, kongestivno srčno popuščanje, bolezen koronarnih arterij, angina pektoris, perikardni izliv, atrijska fibrilacija, zmanjšanje iztisnega deleža, akutni koronarni sindrom, atrijska undulacija občasni miokardna ishemija, kardialno nelagodje, ishemična kardiomiopatija, spazem koronarnih arterij, disfunkcija levega prekata
English: High density polyethylene (HDPE) bottles with screw-top closures, containing either 30, 60 or 180 film-coated tablets, together with one plastic canister containing a molecular sieve desiccant.
Slovenian: Vsebnik iz polietilena visoke gostote (HDPE) z navojno zaporko, ki vsebujejo 30, 60 ali 180 filmsko obloženih tablet, skupaj s plastično posodo s sušilnim sredstvom, ki vsebuje molekulsko sito.
English: Each film-coated tablet contains 80 mg of lactose monohydrate.
Slovenian: Ena filmsko obložena tableta vsebuje 80 mg laktoze monohidrata.
English: In a study in rats, diffuse corneal edema with neutrophilic cell infiltration, and hyperplastic changes in the lenticular epithelium suggestive of a mild phototoxic reaction were observed in animals treated with 5 and 10 mg/kg ponatinib.
Slovenian: V študiji pri podganah so pri živalih, ki so dobivale 5 in 10 mg/kg ponatiniba, opazili difuzni edem roženice z infiltracijo nevtrofilnih celic in hiperplastične spremembe epitelija leče, kar kaže na blage fototoksične reakcije.
English: With once-daily dosing, plasma exposures of ponatinib are increased by approximately 1.5-fold between first dose and steady state conditions.
Slovenian: Z odmerjanjem enkrat na dan se je med prvim odmerkom in stanjem dinamičnega ravnovesja plazemska izpostavljenost ponatinibu povečala za približno 1,5-krat.
English: Stop breast-feeding during treatment with Iclusig.
Slovenian: Med zdravljenjem z zdravilom Iclusig ne smete dojiti.
English: The probability of all patients with CP CML maintaining MCyR and MMR did not change further when the analysis was extended out to 5 years.
Slovenian: Ko so analizo podaljšali na 5 let, se verjetnost pri bolnikih s CP-KM, ki vzdržujejo MCyR in MMR, ni spremenila.
English: • diarrhoea, vomiting, nausea
Slovenian: • driska, bruhanje, siljenje na bruhanje
English: The bottle contains one sealed canister containing a molecular sieve desiccant.
Slovenian: Plastenka vsebuje eno zaprto posodo s sušilnim sredstvom, ki vsebuje molekulsko sito.
English: • fluid in the thorax (may cause breathing difficulty)
Slovenian: • tekočina v prsnem košu (lahko povzroči oteženo dihanje)
English: High density polyethylene (HDPE) bottles with screw-top closures, containing 30 film-coated tablets, together with one plastic canister containing a molecular sieve desiccant.
Slovenian: Vsebnik iz polietilena visoke gostote (HDPE) z navojno zaporko, ki vsebujejo 30 filmsko obloženih tablet, skupaj s plastično posodo s sušilnim sredstvom, ki vsebuje molekulsko sito.
English: White, biconvex, round film-coated tablet that is approximately 8 mm in diameter, with "C7" debossed on one side.
Slovenian: Bela, bikonveksna, okrogla filmsko obložena tableta s približno 8 mm premera, z vtisnjeno oznako "C7" na eni strani.
English: High density polyethylene (HDPE) bottles with screw-top closures, containing either 30 or 90 film-coated tablets, together with one plastic canister containing a molecular sieve desiccant.
Slovenian: Vsebnik iz polietilena visoke gostote (HDPE) z navojno zaporko, ki vsebujejo 30 ali 90 filmsko obloženih tablet, skupaj s plastično posodo s sušilnim sredstvom, ki vsebuje molekulsko sito.
English: Dose interruption or discontinuation may be required as described in Table 3.
Slovenian: Kot je opisano v preglednici 3, se lahko zahteva prekinitev jemanja odmerka zdravila ali prenehanje jemanja zdravila.