FrancophonIA/ELRC3.0 huggingface dataset:
English: CYP3A4 inducers such as rifampin may decrease plasma pazopanib concentrations.
Slovenian: Induktorji CYP3A4, kot je rifampicin, lahko zmanjšajo koncentracije pazopaniba v plazmi.
English: In the three smallest of these 20 subgroups, the point estimate of the hazard ratio exceeded 1.25; i.e. in subjects with no prior nephrectomy (n=186, HR=1.403, 95% CI (0.955, 2.061)), baseline LDH >1.5 x ULN (n=68, HR=1.72, 95% CI (0.943, 3.139)), and MSKCC: poor risk (n=119, HR=1.472, 95% CI (0.937, 2.313)).
Slovenian: V treh najmanjših od teh 20 podskupin je točkovna ocena razmerja ogroženosti presegla 1,25; te podskupine so bile preiskovanci brez predhodne nefrektomije (n = 186, Rog = 1,403, 95 % IZ (0,955, 2,061)), izhodiščna LDH > 1,5 x ZMN (n = 68, Rog = 1,72, 95 % IZ (0,943; 3,139)) in MSKCC: neugodno tveganje (n = 119, Rog = 1,472, 95 % IZ (0,937; 2,313)).
English: Importantly, only patients with selective histological subtypes of STS were allowed to participate to the study, therefore efficacy and safety of pazopanib can only be considered established for those subgroups of STS and treatment with pazopanib should be restricted to such STS subtypes.
Slovenian: Učinkovitost in varnost pazopaniba sta torej ugotovljeni le za te podskupine STS in zdravljenje s pazopanibom mora biti omejeno na te podvrste STS.
English: If you forget to take Votrient Do not take a double dose to make up for a forgotten dose.
Slovenian: Ne vzemite dvojnega odmerka, če ste pozabili vzeti prejšnji odmerek.
English: Grapefruit juice contains an inhibitor of CYP3A4 and may also increase plasma concentrations of pazopanib.
Slovenian: Sok grenivke vsebuje zaviralec CYP3A4 in tudi lahko poveča koncentracije pazopaniba v plazmi.
English: Clinical studies of pazopanib in combination with pemetrexed (non-small cell lung cancer [NSCLC]) and lapatinib (cervical cancer) were terminated early due to concerns over increased toxicity and/or mortality, and a safe and effective combination dose has not been established with these regimens.
Slovenian: Klinične študije pazopaniba v kombinaciji s pemetreksedom (nedrobnocelični pljučni rak (NDCPR)) oziroma lapatinibom (rak materničnega vratu) so se končale predčasno zaradi problemov z večjo toksičnostjo in/ali umrljivostjo.
English: Male patients (including those who have had vasectomies) should use condoms during sexual intercourse while taking pazopanib and for at least 2 weeks after the last dose of pazopanib to avoid potential exposure to the medicinal product for pregnant partners and female partners of reproductive potential.
Slovenian: Bolniki moškega spola (tudi tisti, ki so imeli vazektomijo) morajo v času jemanja pazopaniba in še najmanj 2 tedna po zadnjem odmerku pazopaniba pri spolnih odnosih uporabljati kondom, s čimer zmanjšujejo možnost, da bi nosečo partnerko oziroma partnerko v rodni dobi izpostavljali zdravilu.
English: The European Medicines Agency has waived the obligation to submit the results of studies with Votrient in all subsets of the paediatric population in treatment of kidney and renal pelvis carcinoma (excluding nephroblastoma, nephroblastomatosis, clear cell sarcoma, mesoblastic nephroma, renal medullary carcinoma and rhabdoid tumour of the kidney) (see section 4.2 for information on paediatric use).
Slovenian: Evropska agencija za zdravila je odstopila od zahteve za predložitev rezultatov študij z zdravilom Votrient za vse podskupine pediatrične populacije za zdravljenje ledvičnega karcinoma in karcinoma ledvičnega pielona (izključujoč nefroblastom, nefroblastomatozo, svetlocelični sarkom, mezoblastni nefrom, ledvični medularni karcinom in rabdoidni tumor ledvic) (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
English: The primary objective of the study was to evaluate and compare the two treatment arms for progression-free survival (PFS) and the principle secondary endpoint was overall survival (OS).
Slovenian: Primarni cilj študije je bil ovrednotiti čas preživetja brez napredovanja bolezni (PFS - progression-free survival) in ga primerjati med obema skupinama zdravljenja, glavni sekundarni opazovani dogodek pa skupno preživetje (OS - overall survival).
English: Pazopanib is a UGT1A1 inhibitor.
Slovenian: Pazopanib je zaviralec UGT1A1.
English: Monitor patients for pulmonary symptoms indicative of ILD/pneumonitis and discontinue pazopanib in patients developing ILD or pneumonitis.
Slovenian: Bolnike nadzorujte glede pljučnih simptomov, ki nakazujejo na IBP/pnevmonitis in pri bolnikih, ki se jim razvije IBP ali pnevmonitis, zdravljenje s pazopanibom zaključite.
English: Administration of a pazopanib 400 mg crushed tablet increased AUC(0-72) by 46% and Cmax by approximately 2 fold and decreased tmax by approximately 2 hours compared to administration of the whole tablet.
Slovenian: Pri uporabi zdrobljene 400 mg tablete pazopaniba se je vrednost AUC(0-72) povečala za približno 46 %, Cmax za približno 2-krat, vrednost tmax pa skrajšala za približno 2 uri v primerjavi z uporabo cele tablete.
English: Laboratory monitoring of thyroid function should be performed periodically and managed as per standard medical practice.
Slovenian: Periodično je treba opravljati laboratorijske preiskave delovanja ščitnice in po potrebi ukrepati v skladu z ustaljeno medicinsko prakso.
English: In a pharmacogenetic meta-analysis of data from 31 clinical studies of pazopanib administered either as monotherapy or in combination with other agents, ALT >5 x ULN (NCI CTC Grade 3) occurred in 19% of HLA-B*57:01 allele carriers and in 10% of non-carriers.
Slovenian: V farmakogenetski metaanalizi podatkov iz 31 kliničnih študij s pazopanibom, ki so ga bolniki prejemali bodisi v monoterapiji ali v kombinaciji z drugimi zdravili, se je pokazalo, da je do zvišanja vrednosti ALT nad 5-kratnik ZMN (3. stopnje po kriterijih NCI CTC) prišlo pri 19 % bolnikov, ki so bili nosilci alela HLA-B*57:01, in pri 10 % tistih, ki niso bili nosilci tega alela.
English: Very common side effects that may show up in your blood or urine tests: - increase in liver enzymes - decrease in albumin in the blood - protein in the urine - decrease in the number of blood platelets (cells that help blood to clot) - decrease in the number of white blood cells
Slovenian: Zelo pogosti neželeni učinki, ki se lahko odkrijejo pri preiskavah krvi ali urina: - zvišana vrednost jetrnih encimov, - znižanje vrednosti albumina v krvi, - beljakovine v urinu, - zmanjšanje števila krvnih ploščic (trombocitov, tj. celic, ki pomagajo pri strjevanju krvi), - zmanjšano število belih krvnih celic.
English: Some medicines may affect how Votrient works or make it more likely that you'll have side effects.
Slovenian: Nekatera zdravila lahko vplivajo na delovanje zdravila Votrient ali povečajo možnost za pojav neželenih učinkov.
English: Your doctor will monitor your blood pressure while you are taking Votrient.
Slovenian: Zdravnik bo med zdravljenjem z zdravilom Votrient nadzoroval vaš krvni tlak.
English: Caution is advised in patients with creatinine clearance below 30 ml/min as there is no experience of pazopanib in this patient population (see section 4.2).
Slovenian: Pri bolnikih s kreatininskim očistkom, manjšim od 30 ml/min, je potrebna previdnost, saj pri tej skupini bolnikov ni izkušenj z uporabo pazopaniba (glejte poglavje 4.2).
English: Concomitant treatment with inducers of CYP3A4 should be avoided due to risk of decreased exposure to pazopanib (see section 4.5).
Slovenian: Sočasnemu zdravljenju z induktorji CYP3A4 se je treba izogibati zaradi tveganja za zmanjšanje izpostavljenosti pazopanibu (glejte poglavje 4.5).
English: Votrient can cause severe bleeding in the digestive system (such as stomach, oesophagus, rectum or intestine), or the lungs, kidneys, mouth, vagina and brain, although this is uncommon.
Slovenian: Zdravilo Votrient lahko povzroči hude krvavitve v prebavilih (npr. želodcu, požiralniku, danki ali črevesu), pljučih, ledvicah, ustih, nožnici ali možganih.
English: Concomitant use of pazopanib with a strong CYP3A4 inhibitor should be avoided (see section 4.4).
Slovenian: Sočasni uporabi pazopaniba z močnim zaviralcem CYP3A4 se je treba izogibati (glejte poglavje 4.4).
English: Sixty-six per cent of placebo patients received post-study therapy compared to 30% of pazopanib patients.
Slovenian: Po študiji je zdravljenje prejemalo 66 % bolnikov, ki so dobivali placebo, in 30 % tistih, ki so dobivali pazopanib.
English: Selection of an alternative concomitant medication with no or minimal enzyme or transporter induction potential is recommended.
Slovenian: Priporočljivo je izbrati alternativno sočasno zdravilo, ki ne inducira ali ima minimalen vpliv na indukcijo encima ali transporterja.
English: Pazopanib may have a greater impact on SN-38 disposition in subjects with the UGT1A1*28 polymorphism relative to subjects with the wild-type allele.
Slovenian: Pazopanib pri osebah s polimorfizmom UGT1A1*28 morda bolj vpliva na odstranjevanje SN-38 kot pri osebah z divjim tipom alela.
English: The most common adverse reactions (experienced by at least 10% of the patients) of any grade in the RCC and STS trials included: diarrhoea, hair colour change, skin hypopigmentation, exfoliative rash, hypertension, nausea, headache, fatigue, anorexia, vomiting, dysgeusia, stomatitis, weight decreased, pain, elevated alanine aminotransferase and elevated aspartate aminotransferase.
Slovenian: Najpogostejši neželeni učinki (ki so se pojavili vsaj pri 10 % bolnikov) katere koli stopnje v študijah pri RCC in STS so bili: driska, sprememba barve las, hipopigmentacija kože, eksfoliativen izpuščaj, hipertenzija, navzea, glavobol, utrujenost, anoreksija, bruhanje, disgevzija, stomatitis, zmanjšanje telesne mase, bolečina, zvišanje vrednosti alanin-aminotransferaze in zvišanje vrednosti aspartataminotransferaze.
English: Signs that your liver may not be working properly may include: - yellowing of your skin or the whites of your eyes (jaundice) - dark urine - tiredness - nausea - vomiting - loss of appetite - pain on the right side of your stomach area (abdomen) - bruising easily
Slovenian: Znaki, da vaša jetra mogoče ne delujejo pravilno lahko vključujejo: - porumenelost kože ali beločnic (zlatenica), - temen urin, - utrujenost, - siljenje na bruhanje, - bruhanje, - izguba apetita, - bolečina na desni strani trebuha, - hiter nastanek modric.
English: Dysgeusia, ageusia and hypogeusia d White cell count decreased, neutrophil count decreased and leukocyte count decreased e
Slovenian: Dizgevzija, agevzija in hipogevzija d Zmanjšanje števila belih celic, zmanjšanje števila nevtrofilcev in zmanjšanje števila levkocitov e
English: The European Medicines Agency has deferred the obligation to submit the results of studies with Votrient in one or more subsets of the paediatric population in the treatment of rhabdomyosarcoma, non-rhabdomyosarcoma soft tissue sarcoma and Ewing sarcoma family of tumours (see section 4.2 for information on paediatric use).
Slovenian: Evropska agencija za zdravila je začasno odložila zahtevo za predložitev rezultatov študij z zdravilom Votrient za eno ali več podskupin pediatrične populacije za zdravljenje rabdomiosarkoma, nerabdomiosarkomskega sarkoma mehkih tkiv in tumorjev iz družine Ewingovega sarkoma (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
English: Following reintroduction of pazopanib, if transaminase elevations >3 x ULN recur, then pazopanib should be permanently discontinued.
Slovenian: Če se po ponovni uvedbi zdravljenja s pazopanibom vrednosti aminotransferaz spet zvišajo na > 3kratno ZMN, je treba zdravljenje s pazopanibom trajno ukiniti.
English: HR = hazard ratio; ITT = intent to treat; PFS = progression-free survival; CR = complete response; PR = partial response.
Slovenian: ROg = razmerje ogroženosti, ITT = vključeni bolniki, PFS = preživetje brez napredovanja, PO = popolni odziv, DO = delni odziv.
English: What Votrient contains - The active substance is pazopanib (as hydrochloride).
Slovenian: Kaj vsebuje zdravilo Votrient - Učinkovina je pazopanib (v obliki pazopanibijevega klorida).
English: Venous thromboembolic event, deep vein thrombosis, pulmonary embolism and thrombosis
Slovenian: Venski trombembolični dogodki, globoka venska tromboza, pljučna embolija in tromboza
English: Based on safety and tolerability data, the dose of pazopanib should be reduced to 200 mg once daily in subjects with moderate hepatic impairment (see section 4.2).
Slovenian: Na osnovi podatkov o varnosti in prenašanju je treba pri bolnikih z zmerno okvaro jeter odmerek pazopaniba zmanjšati na 200 mg enkrat na dan (glejte poglavje 4.2).
English: In two-year carcinogenicity studies with pazopanib, there were increased numbers of liver adenomas noted in mice and duodenal adenocarcinomas noted in rats.
Slovenian: V študijah kancerogenega potenciala pazopaniba, ki so trajale 2 leti, so opazili povečano število adenomov jeter pri miših in povečano število adenokarcinomov dvanajstnika pri podganah.
English: Co-administration with potent P-gp or BCRP inhibitors may also alter the exposure and distribution of pazopanib, including distribution into the central nervous systems (CNS).
Slovenian: Sočasna uporaba z močnimi zaviralci P-gp ali BCRP lahko tudi spremeni izpostavljenost pazopanibu in njegovo porazdelitev, vključno s porazdelitvijo v osrednje živčevje.
English: Figure 4 Kaplan-Meier Curve for progression-free survival by independent assessment for the overall population (VEG108844)
Slovenian: Slika 4 Kaplan-Meierjeva krivulja preživetja brez napredovanja za celotno populacijo po neodvisni oceni (VEG108844)
English: All grades n (%)
Slovenian: Vse stopnje n (%)
English: HR = hazard ratio; ITT = intent to treat; PFS = progression-free survival.
Slovenian: HR = razmerje tveganj; ITT = vključeni bolniki; PFS = čas preživetja brez napredovanja bolezni.
English: Median PFS was 11.9 months.
Slovenian: Mediana vrednost časa preživetja brez napredovanja bolezni je bila 11,9 meseca.
English: In clinical studies with pazopanib, venous thromboembolic events including venous thrombosis and fatal pulmonary embolus have occurred.
Slovenian: V kliničnih študijah pazopaniba so se pojavili venski trombembolični dogodki, vključno z vensko trombozo in smrtno pljučno embolijo.
English: The performance status (ECOG) was similar between the pazopanib and placebo groups (ECOG 0: 42% vs. 41%, ECOG 1: 58% vs. 59%).
Slovenian: Stanje telesne zmogljivosti (ECOG) bolnikov je bilo v skupini, ki je prejemala pazopanib, podobno kot v skupini, ki je prejemala placebo (ECOG 0: pazopanib 42 %, placebo 41 %, ECOG 1: pazopanib 58 %, placebo 59 %).
English: Uncommon side effects (may affect up to 1 in 100 people): - stroke - temporary fall in blood supply to the brain (transient ischaemic attack) - interruption of blood supply to part of the heart or heart attack (myocardial infarction) - partial interruption of blood supply to part of the heart (myocardial ischaemia) - blood clots accompanied by a decrease in red blood cells and cells involved in clotting
Slovenian: Občasni neželeni učinki (lahko se pojavijo pri največ 1 od 100 bolnikov): - možganska kap, - prehodno zmanjšanje oskrbe možganov s krvjo (tranzitorna ishemična ataka), - prekinitev oskrbe dela srca s krvjo ali srčni napad (srčna kap), - delna prekinitev oskrbe dela srca s krvjo (miokardna ishemija), - krvni strdki, ki jih spremlja zmanjšanje števila rdečih krvnih celic in celic, ki sodelujejo pri strjevanju krvi (trombotična mikroangiopatija).
English: Animal studies indicate that male and female fertility may be affected by treatment with pazopanib (see section 5.3).
Slovenian: Študije na živalih kažejo, da zdravljenje s pazopanibom lahko vpliva na plodnost moških in žensk (glejte poglavje 5.3).
English: Decreases in LVEF in subjects who had post-baseline and follow-up LVEF measurement were detected in 11% (15/140) in the pazopanib arm, compared with 3% (1/39) in the placebo arm.
Slovenian: Med preiskovanci, ki so jim opravili meritev LVEF po izhodiščni meritvi in kontrolne meritve LVEF, so zmanjšanje LVEF ugotovili pri 11 % (15/140) prejemnikov pazopaniba in pri 3 % (1/39) prejemnikov placeba.
English: Therefore, activity of pazopanib is mainly dependent on parent pazopanib exposure.
Slovenian: Delovanje pazopaniba je tako v glavnem odvisno od izpostavljenosti izvorni učinkovini.
English: Very common Hypertension Common Venous thromboembolic eventd Hot flush Flushing Uncommon Haemorrhage Not known Aneurysms and artery dissections
Slovenian: Žilne bolezni zelo pogosti hipertenzija pogosti venski trombembolični dogodki d navali vročine zardevanje občasni krvavitev pogostnost neznana anevrizme in disekcije arterij neznana neznana neznana
English: Votrient can affect how well your heart pumps or can increase the likelihood of having a heart attack.
Slovenian: Zdravilo Votrient lahko vpliva na delovanje vašega srca in lahko poveča tveganje za srčno kap.
English: - Tell your doctor if you are pregnant or planning to get pregnant.
Slovenian: - Če ste noseči ali nameravate zanositi, o tem obvestite svojega zdravnika.
English: They are supplied in bottles of 30 or 60 tablets.
Slovenian: Na voljo so v plastenkah, ki vsebujejo 30 ali 60 tablet.
English: Signs and symptoms may include: - severe stomach pain - nausea and/or vomiting - fever - development of a hole (perforation) in the stomach, intestine or bowel from which bloody or foul smelling pus is released
Slovenian: Znaki in simptomi lahko vključujejo: - hudo bolečino v želodcu, - siljenje na bruhanje in/ali bruhanje, - zvišano telesno temperaturo, - nastanek luknje (perforacije) v želodcu ali črevesju, od koder se izloča krvav ali smrdeč gnojen izcedek.
English: Synovial sarcoma subgroups
Slovenian: Podskupine sinovijskega sarkoma*
English: The primary analysis of the primary endpoint PFS is based on disease assessment by independent radiological review in the entire study population (treatment-naïve and cytokine pre-treated).
Slovenian: Primarna analiza primarnega opazovanega dogodka, to je čas preživetja brez napredovanja bolezni, temelji na neodvisni presoji radiološkega pregleda celotne študijske populacije (predhodno še nezdravljeni bolniki in bolniki, ki so se predhodno že zdravili s citokini).
English: Caution is advised in patients with creatinine clearance below 30 ml/min as there is no experience of pazopanib in this patient population.
Slovenian: Pri bolnikih s kreatininskim očistkom, manjšim od 30 ml/min, je potrebna previdnost, saj pri tej skupini bolnikov ni izkušenj z uporabo pazopaniba.
English: Grade 4 n (%)
Slovenian: Stopnja 4 n (%)
English: Fatal events have been observed.
Slovenian: Zabeležili so dogodke s smrtnim izidom.
English: Common side effects that may show up in your blood or urine tests: - underactive thyroid gland - abnormal liver function - increase in bilirubin (a substance produced by the liver) - increase in lipase (an enzyme involved in digestion - increase in creatinine (a substance produced in muscles) - changes in the levels of other different chemicals / enzymes in the blood.
Slovenian: Pogosti neželeni učinki, ki se lahko odkrijejo pri preiskavah krvi ali urina: - zmanjšano delovanje ščitnice, - nenormalno delovanje jeter, - zvišanje vrednosti bilirubina (substanca, ki nastaja v jetrih), - zvišanje vrednosti lipaze (encim, ki sodeluje pri prebavi), - zvišanje vrednosti kreatinina (substanca, ki nastaja v mišicah), - spremembe koncentracije različnih drugih snovi ali encimov v krvi.
English: Pazopanib is an inhibitor of the uridine diphosphoglucuronosyl-transferase 1A1 (UGT1A1) enzyme in vitro.
Slovenian: Pazopanib in vitro zavira encim uridin-difosfoglukuronozil-transferazo 1A1 (UGT1A1).
English: They are supplied in bottles of 30 or 90 tablets.
Slovenian: Na voljo so v plastenkah, ki vsebujejo 30 ali 90 tablet.
English: Therefore, pazopanib should be administered at least two hours after food or at least one hour before food (see section 4.2).
Slovenian: Pazopanib je zato treba uporabljati vsaj dve uri po jedi ali eno uro pred jedjo (glejte poglavje 4.2).
English: HDPE bottles with polypropylene child resistant closures containing either 30 or 90 tablets.
Slovenian: Plastenke iz polietilena visoke gostote (HDPE) z za otroke varno zaporko, ki vsebujejo 30 ali 90 tablet.
English: When using pazopanib, baseline and periodic monitoring of electrocardiograms and maintenance of electrolytes (e.g. calcium, magnesium, potassium) within normal range is recommended.
Slovenian: Pred začetkom zdravljenja s pazopanibom je priporočljivo izvesti elektrokardiografsko preiskavo srca in jo nato med zdravljenjem občasno ponavljati ter skrbeti za ravnovesje elektrolitov (npr. kalcij, magnezij, kalij) znotraj mej normalnih vrednosti.
English: HDPE bottles with polypropylene child resistant closures containing either 30 or 60 tablets.
Slovenian: Plastenke iz polietilena visoke gostote (HDPE) z za otroke varno zaporko, ki vsebujejo 30 ali 60 tablet.
English: Pulmonary haemorrhage
Slovenian: Vnetje pljuč
English: (thrombotic microangiopathy, TMA).
Slovenian: Trombotična mikroangiopatija (TMA)
English: Uncommon Thrombotic microangiopathy (including thrombotic thrombocytopenic purpura and haemolytic uraemic syndrome)
Slovenian: nevtropenija občasni trombotična mikroangiopatija (vključno s trombotično trombocitopenično purpuro in hemolitičnouremičnim sindromom) †
English: Patients on pazopanib treatment should be observed closely for signs and symptoms of pneumothorax.
Slovenian: Med zdravljenjem s pazopanibom je treba bolnike natančno kontrolirati glede znakov in simptomov pnevmotoraksa.
English: Table 4 Overall efficacy results in RCC by independent assessment (VEG105192)
Slovenian: Preglednica 4 Rezultati skupne učinkovitosti pri RCC na osnovi neodvisne presoje (VEG105192)
English: PFS Overall* ITT
Slovenian: Celokupni* ITT
English: A detrimental effect on such activities cannot be predicted from the pharmacology of pazopanib.
Slovenian: Iz farmakologije pazopaniba se škodljiv vpliv na tovrstne aktivnosti ne more predvideti.
English: Cardiac dysfunction/Heart failure
Slovenian: Moteno delovanje srca/srčno popuščanje
English: Selection of alternative concomitant medicinal products with no or minimal potential to inhibit CYP3A4, P-gp or BCRP should be considered.
Slovenian: Pretehtati je treba uporabo drugih zdravil za sočasno uporabo, ki imajo majhen potencial za zaviranje CYP3A4, Pgp ali BCRP, ali takšnega potenciala sploh nimajo.
English: Deep vein thrombosis (DVT) and pulmonary embolism Votrient may cause blood clots in your veins, especially in your legs (deep vein thrombosis or DVT), which may also travel to your lungs (pulmonary embolism).
Slovenian: Zdravilo Votrient lahko povzroči nastanek krvnih strdkov v vaših venah, še posebej v venah nog (globoka venska tromboza), ki lahko nato potujejo v pljuča (pljučna embolija).
English: Co-administration of pazopanib with a CYP3A4, P-gp, and BCRP inhibitor, such as lapatinib, will result in an increase in plasma pazopanib concentrations.
Slovenian: Pri sočasni uporabi pazopaniba skupaj z zaviralci CYP3A4, P-gp in BCRP, kot je lapatinib, se koncentracije pazopaniba v plazmi povečajo.
English: Signs and symptoms include: - irregular or fast heartbeat - rapid fluttering of your heart - fainting - chest pain or pressure - pain in your arms, back, neck or jaw - shortness of breath - leg swelling
Slovenian: Znaki in simptomi vključujejo: - nereden ali hiter srčni utrip, - hitro utripanje srca, - omedlevico, - bolečino ali pritisk v prsih, - bolečine v rokah, hrbtu, vratu ali čeljusti, - kratko sapo, - zatekanje nog.
English: Do not use this medicine after the expiry date (EXP) which is stated on the bottle and the carton.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na plastenki in škatli poleg oznake EXP. Rok uporabnosti zdravila se izteče na zadnji dan navedenega meseca.