FrancophonIA/ELRC3.0 huggingface dataset:
English: Within each frequency group, undesirable effects are presented in order of decreasing seriousness.
Slovenian: V razvrstitvah pogostosti so neželeni učinki navedeni po padajoči resnosti.
English: A diagnosis of PRES requires confirmation by brain imaging.
Slovenian: Diagnozo PRES je treba potrditi s slikanjem možganov.
English: Stivarga may reduce fertility in both men and women.
Slovenian: Zdravilo Stivarga lahko zmanjša plodnost pri moških in ženskah.
English: If you have any questions about how Stivarga works or why this medicine has been prescribed for you, please ask your doctor.
Slovenian: Če imate kakršna koli vprašanja o delovanju zdravila Stivarga ali zakaj vam je bilo to zdravilo predpisano, se posvetujte z zdravnikom.
English: StevensJohnson syndrome Toxic epidermal necrolysis
Slovenian: StevensJohnsonov sindrom toksična epidermalna nekroliza
English: The mean elimination half-life for the metabolite M-5 is approximately 60 hours (range from 40 to 100 hours).
Slovenian: Povprečni razpolovni čas izločanja za presnovek M-5 je približno 60 ur (razpon od 40 do 100 ur).
English: A slightly increased incidence of thickening of the atrioventricular valves of the heart was seen in the 26 week repeat-dose toxicity study in rats.
Slovenian: Nekoliko večjo incidenco zadebelitve atrioventrikularnih srčnih zaklopk so opazili v 26-tedenski študiji toksičnosti ponavljajočih odmerkov pri podganah.
English: If you miss a dose, take it as soon as you remember on that day.
Slovenian: Če pozabite vzeti odmerek, ga vzemite takoj, ko se spomnite.
English: There are no data on the effect of Stivarga on human fertility.
Slovenian: Ni podatkov o vplivu zdravila Stivarga na plodnost pri ljudeh.
English: Your doctor will monitor your blood pressure prior to and during treatment and may give you a medicine to treat high blood pressure.
Slovenian: Zdravnik vam bo spremljal krvni tlak pred in med zdravljenjem ter vam po potrebi predpisal zdravilo za zdravljenje visokega krvnega tlaka.
English: Do not drive or use any tools or machines if you experience treatment-related symptoms that affect your ability to concentrate and react.
Slovenian: Ne vozite ali upravljajte strojev, če občutite z zdravljenjem povezane simptome, ki vplivajo na vašo zbranost in odzivnost.
English: The clinical significance of these findings is unknown (see also section 5.2).
Slovenian: Klinični pomen teh izsledkov ni znan (glejte tudi poglavje 5.2).
English: Exception: patients with Gilbert's syndrome who develop elevated transaminases should be managed as per the above outlined recommendations for the respective observed elevation of ALT and/or AST.
Slovenian: Izjema: bolnike z Gilbertovim sindromom, pri katerih so se povečale vrednosti transaminaz, je treba zdraviti po zgornjih priporočilih glede na opaženo povečanje vrednosti ALT in/ali AST.
English: Measures for the prevention of HFSR include control of calluses and use of shoe cushions and gloves to prevent pressure stress to soles and palms.
Slovenian: Ukrepi za preprečevanje HFSR vključujejo spremljanje kalusov in uporabo vložkov za čevlje ter rokavic za preprečevanje poškodb zaradi pritiska na podplate in dlani.
English: The tablets should be swallowed whole with water after a light meal that contains less than 30% fat.
Slovenian: Tablete pogoltnite cele z vodo po lahkem obroku, ki vsebuje manj kot 30 % maščob.
English: Do not take two doses of Stivarga on the same day to make up for a missed dose from the previous day.
Slovenian: Ne vzemite dveh odmerkov zdravila Stivarga na isti dan, da bi nadomestili izpuščeni odmerek prejšnjega dne.
English: The clinical significance of these potential interactions is unknown, but may result in a decreased efficacy of regorafenib.
Slovenian: Klinični pomen teh možnih interakcij je neznan, vendar lahko privede do zmanjšane učinkovitosti regorafeniba.
English: What Stivarga is and what it is used for
Slovenian: Kaj je zdravilo Stivarga in za kaj ga uporabljamo
English: You will usually take Stivarga as long as you are benefiting and not suffering unacceptable side effects.
Slovenian: Običajno se zdravilo Stivarga jemlje tako dolgo, dokler vam koristi in se vam ne pojavijo nesprejemljivi neželeni učinki.
English: In vitro protein binding of regorafenib to human plasma proteins is high (99.5%).
Slovenian: In vitro je vezava regorafeniba na humane plazemske proteine velika (99,5 %).
English: Decrease dose by 40 mg (one tablet) and immediately institute supportive measures.
Slovenian: Odmerek je treba zmanjšati za 40 mg (ena tableta) in takoj uvesti podporne ukrepe.
English: • Barcelona Clinic Liver Cancer (BCLC) stage B: 13%; BCLC stage C: 87%
Slovenian: • stopnja B po BCLC (Barcelona Clinic Liver Cancer): 13 %; stopnja C po BCLC: 87 %
English: The patient should not take two doses on the same day to make up for a missed dose.
Slovenian: Bolnik ne sme vzeti dveh odmerkov isti dan, da nadomesti izpuščeni odmerek.
English: M-5 is finally excreted via M-4 as M-6 (carboxylic acid) in faeces.
Slovenian: M-5 se na koncu izloči preko M-4 kot M-6 (karboksilna kislina) v blatu.
English: Some medicines may affect the way Stivarga works or Stivarga may affect how other medicines work and cause serious side effects.
Slovenian: Nekatera zdravila lahko vplivajo na delovanje zdravila Stivarga, zdravilo Stivarga pa lahko vpliva na delovanje nekaterih drugih zdravil in povzroči resne neželene učinke.
English: * fatal cases have been reported ** palmar-plantar erythrodysesthesia syndrome in MedDRA terminology # according to drug-induced liver injury (DILI) criteria of the international DILI expert working group
Slovenian: * poročali so o smrtnih primerih ** sindrom palmarno-plantarne eritrodizestezije po terminologiji MedDRA # glede na kriterije za okvaro jeter zaradi zdravil (DILI - drug-induced liver injury) mednarodne delovne skupine DILI
English: In clinical studies, no relevant differences in exposure, safety or efficacy were observed between elderly (aged 65 years and above) and younger patients (see also section 5.2).
Slovenian: V kliničnih študijah niso opazili pomembnih razlik v izpostavljenosti, varnosti ali učinkovitosti med starejšimi (starost 65 let in več) in mlajšimi bolniki (glejte tudi poglavje 5.2).
English: If you forget to take Stivarga
Slovenian: Če ste pozabili vzeti zdravilo Stivarga
English: Metabolite M-5 is a weak BCRP-substrate.
Slovenian: Presnovek M-5 je šibek substrat BCRP.
English: Treatment should continue as long as benefit is observed or until unacceptable toxicity occurs (see section 4.4).
Slovenian: Zdravljenje je treba nadaljevati, dokler so opazne koristi ali do pojava nesprejemljivih škodljivih učinkov (glejte poglavje 4.4).
English: The majority of patients with PS ≥2 discontinued treatment for progressive disease.
Slovenian: Večina bolnikov s PS ≥ 2 je zdravljenje prekinila zaradi napredovanja bolezni.
English: Patients continued therapy with Stivarga until clinical or radiological disease progression or unacceptable toxicity.
Slovenian: Bolniki so nadaljevali zdravljenje z zdravilom Stivarga do kliničnega ali radiološko potrjenega napredovanja bolezni ali nesprejemljive toksičnosti.
English: The decision to resume treatment with Stivarga following major surgical intervention should be based on clinical judgment of adequate wound healing.
Slovenian: Odločitev o ponovni uvedbi zdravljenja z zdravilom Stivarga po velikem kirurškem posegu mora temeljiti na klinični presoji ustreznosti celjenja ran.
English: Thereafter, the medicinal product is to be discarded.
Slovenian: Nato je treba zdravilo zavreči.
English: Tell your doctor about any missed dose.
Slovenian: Zdravnika obvestite o vsakem izpuščenem odmerku.
English: Regorafenib could harm infant growth and development (see section 5.3).
Slovenian: Regorafenib lahko škoduje rasti in razvoju dojenčka (glejte poglavje 5.3).
English: - dry mouth - decreased appetite - high blood pressure (hypertension) - excessive tiredness (fatigue).
Slovenian: - suha usta, - zmanjšan apetit, - visok krvni tlak (hipertenzija), - pretirana utrujenost (izčrpanost).
English: Restart: If the potential benefit outweighs the risk of hepatotoxicity, re-start Stivarga treatment, reduce dose by 40 mg (one tablet), and monitor liver function weekly for at least 4 weeks.
Slovenian: Ponovna uvedba zdravljenja: Če so možne koristi večje od tveganja za hepatotoksičnost, se ponovno uvede zdravljenje z zdravilom Stivarga, odmerek je treba zmanjšati za 40 mg (ena tableta) in vsaj 4 tedne vsak teden spremljati delovanje jeter.
English: Maintain dose level and immediately institute supportive measures for symptomatic relief.
Slovenian: Velikost odmerka je treba ohraniti in takoj uvesti podporne ukrepe za lajšanje simptomov.
English: Environmental risk assessment studies have shown that regorafenib has the potential to be persistent, bioaccumulative and toxic to the environment and may pose a risk to the surface water and to the sediment compartment (see section 6.6).
Slovenian: Študije ocene tveganja za okolje so pokazale da se regorafenib lahko trajno kopiči in je toksičen za okolje ter da lahko predstavlja tveganje za površinske vode in usedline (glejte poglavje 6.6).
English: Regorafenib is mainly eliminated via the liver, and exposure might be increased in this patient population.
Slovenian: Regorafenib se pretežno izloča skozi jetra, zato je lahko pri teh bolnikih izpostavljenost povečana.
English: The safety profile of Stivarga plus BSC in the CONCUR study was consistent with the safety profile observed in the CORRECT study.
Slovenian: Profil varnosti zdravila Stivarga in najboljša podporna oskrba v študiji CONCUR je bil skladen s profilom varnosti, ki so ga opazili v študiji CORRECT.
English: Women of childbearing potential/Contraception in males and females Women of childbearing potential must be informed that regorafenib may cause foetal harm.
Slovenian: Ženske v rodni dobi / kontracepcija pri moških in ženskah Ženske v rodni dobi je treba obvestiti, da lahko regorafenib škoduje plodu.
English: In vitro protein binding of M-2 and M-5 is higher (99.8% and 99.95%, respectively) than that of regorafenib.
Slovenian: In vitro je vezava M-2 in M-5 na proteine večja (99,8 % oz. 99,95 %) kot vezava regorafeniba.
English: The analysis of the primary efficacy endpoint Progression-Free Survival (PFS) was conducted after 144 PFS events (central blinded assessment).
Slovenian: Analizo primarnega cilja učinkovitosti, preživetja brez napredovanja bolezni (PFS, Progression-Free Survival), so izvedli po 144 dogodkih PFS (osrednja ocena na slepo).
English: CYP isoform-selective substrates
Slovenian: Selektivni substrati izooblik CYP
English: If you notice any changes contact your doctor.
Slovenian: Če opazite kakršne koli spremembe, se posvetujte z zdravnikom.
English: There is no specific antidote for Stivarga overdose.
Slovenian: Specifičnega antidota za preveliko odmerjanje zdravila Stivarga ni na voljo.
English: A KRAS mutation was reported in 57% of patients at study entry.
Slovenian: Ob vključitvi v študijo so o mutaciji gena KRAS poročali pri 57 % bolnikov.
English: If you get this side effect, your doctor may change your dose or stop your treatment until your condition improves.
Slovenian: Če se vam pojavijo ti neželeni učinki, vam bo zdravnik morda spremenil odmerek ali prekinil zdravljenje, dokler se stanje ne izboljša.
English: • ECOG Performance Status (PS) of 0: 66% or ECOG PS of 1: 34%
Slovenian: • status zmogljivosti 0 po ECOG: 66 % ali status zmogljivost 1 po ECOG: 34 %
English: Close monitoring of overall safety is recommended in these patients (see sections 4.4 and 5.2).
Slovenian: Pri teh bolnikih se priporoča skrbno spremljanje splošne varnosti (glejte tudi poglavji 4.4 in 5.2).
English: Secondary endpoints including Time To Progression (TTP) and Overall Survival (OS (interim analysis) were also assessed.
Slovenian: Ocenili so tudi sekundarne cilje učinkovitosti, kot so čas do napredovanja bolezni (TTP - Time To Progression) in celokupno preživetje (OS -- Overall Survival) (vmesna analiza).
English: The lowest recommended daily dose is 80 mg.
Slovenian: Najmanjši priporočeni dnevni odmerek je 80 mg.
English: If your liver function is severely impaired, you should not be treated with Stivarga, as there are no data on the use of Stivarga in patients with a severely impaired liver function.
Slovenian: Če imate hudo okvaro jeter, se ne smete zdraviti z zdravilom Stivarga, ker ni na voljo podatkov o uporabi zdravila Stivarga pri bolnikih s hudo okvaro jeter.
English: It is recommended to monitor blood pressure and to treat hypertension in accordance with standard medical practice.
Slovenian: Priporoča se spremljanje krvnega tlaka in zdravljenje hipertenzije v skladu s standardno klinično prakso.
English: In rats, regorafenib or its metabolites are excreted in milk.
Slovenian: Pri podganah se regorafenib ali njegovi presnovki izločajo v mleko.
English: The recommended daily dose in adults is 4 tablets of Stivarga 40 mg (160 mg regorafenib).
Slovenian: Priporočeni dnevni odmerek pri odraslih je 4 tablete zdravila Stivarga 40 mg (160 mg regorafeniba).
English: - if you develop a severe and persistent headache, visual disturbances, seizures or altered mental status (such as confusion, memory loss or loss of orientation) please contact your doctor immediately.
Slovenian: - če se pojavijo hud ali dolgotrajen glavobol, motnje vida, epileptični napadi ali spremembe duševnega stanja (kot je zmedenost, izguba spomina ali izguba orientacije), se takoj posvetujte z zdravnikom.
English: This indicates that co-administration of regorafenib may increase the plasma concentrations of other concomitant BCRP substrates (e.g. methotrexate, fluvastatin, atorvastatin).
Slovenian: To kaže, da sočasna uporaba regorafeniba lahko poveča plazemske koncentracije drugih sočasno uporabljenih substratov BCRP (npr. metotreksat, fluvastatin, atorvastatin).
English: In most cases of severe liver injury, liver dysfunction had an onset within the first 2 months of therapy, and was characterized by a hepatocellular pattern of injury with transaminase elevations >20xULN, followed by bilirubin increase.
Slovenian: V večini primerov hude okvare jeter, se je moteno delovanje jeter pojavilo v prvih dveh mesecih zdravljenja, in je bila zanj značilna poškodba jetrnih celic s povečanimi vrednostmi transaminaz > 20 x ULN, ki so mu sledile povečane vrednosti bilirubina.
English: This indicates that co-administration of regorafenib may increase systemic exposure to UGT1A1 and UGT1A9 substrates.
Slovenian: To kaže, da lahko sočasna uporaba regorafeniba poveča sistemsko izpostavljenost substratoma UGT1A1 in UGT1A9.
English: In addition, regorafenib reduced the levels of tumour associated macrophages and has shown anti-metastatic effects in vivo.
Slovenian: Poleg tega je regorafenib zmanjšal ravni s tumorjem povezanih makrofagov in in vivo pokazal tudi učinke proti metastazam.
English: Once the bottle is opened the medicinal product has shown to be stable for 7 weeks.
Slovenian: Po prvem odprtju plastenke je zdravilo stabilno 7 tednov.
English: Contains sodium and lecithin (derived from soya).
Slovenian: SEZNAM POMOŽNIH SNOVI Vsebuje natrij in lecitin (pridobljen iz soje).
English: These events are also known to be common disease-related complications in patients with intra-abdominal malignancies.
Slovenian: Znano je, da so to pogosti zapleti, povezani z boleznijo, pri bolnikih z intraabdominalnimi malignimi tumorji.
English: Before you start taking Stivarga your doctor may decide to do blood tests.
Slovenian: Pred začetkom jemanja zdravila Stivarga se bo zdravnik morda odločil za krvne preiskave.
English: Based on its mechanism of action regorafenib is suspected to cause foetal harm when administered during pregnancy.
Slovenian: Glede na mehanizem delovanja regorafeniba obstaja sum, da njegova uporaba pri nosečnicah škoduje plodu.
English: Clinical data indicate that regorafenib has no effect on digoxin pharmacokinetics, therefore can be given concomitantly with p-glycoprotein substrates, such as digoxin, without a clinically meaningful drug interaction.
Slovenian: Klinični podatki kažejo, da regorafenib ne vpliva na farmakokinetiko digoksina, zato se ga lahko daje sočasno s substrati glikoproteina P, npr. digoksin, ne da bi prišlo do klinično pomembnega medsebojnega delovanja.
English: Before you take Stivarga tell your doctor if any of these conditions apply to you.
Slovenian: Pred začetkom jemanja zdravila Stivarga, se posvetujte z zdravnikom, če se katero koli od teh stanj nanaša na vas.
English: Pharmacotherapeutic group: Antineoplastic agents, protein kinase inhibitor; ATC Code: L01XE21
Slovenian: Farmakoterapevtska skupina: zdravila z delovanjem na novotvorbe, zaviralci proteinskih kinaz; oznaka ATC: L01XE21
English: System Organ Class (MedDRA)
Slovenian: Organski sistem (po MedDRA)
English: Following single doses of 60 mg or 100 mg, the average relative bioavailability of tablets compared to an oral solution was 69% and 83%, respectively.
Slovenian: Po enkratnem odmerku 60 mg oziroma 100 mg je bila povprečna relativna biološka uporabnost tablet v primerjavi s peroralno raztopino 69 % oziroma 83 %.
English: The exposure for regorafenib was increased by 48% when administered with a high-fat breakfast, and 36% when administered with a low fat breakfast, compared to fasting.
Slovenian: Izpostavljenost regorafenibu se je povečala za 48 %, ko je bil zaužit z zajtrkom, ki je vseboval veliko maščob in za 36 %, ko je bil zaužit z zajtrkom, ki je vseboval malo maščob, v primerjavi z izpostavljenostjo, ko je bil zaužit na tešče.
English: - if you have high blood pressure Stivarga can raise your blood pressure.
Slovenian: - če imate visok krvni tlak.
English: The abnormalities are generally of mild to moderate severity, not associated with clinical manifestations, and do not usually require dose interruptions or reductions.
Slovenian: Odstopanja od normalnih vrednosti so običajno majhna do zmerna in niso klinično izražena ter običajno zaradi tega ni treba prekiniti zdravljenja ali zmanjšati odmerka.
English: >20 times ULN (Grade 4)
Slovenian: > 20-kratnik ULN (stopnja 4)
English: In clinical studies, no relevant differences in exposure or efficacy were observed between patients of different ethnic groups.
Slovenian: V kliničnih študijah niso opazili pomembnih razlik v izpostavljenosti ali učinkovitosti med bolniki iz različnih etničnih skupin.
English: P-value (one-sided)
Slovenian: Vrednost p (enostranska)
English: There is limited data in patients with PS ≥2.
Slovenian: Podatkov o bolnikih s PS ≥ 2 je malo.
English: What Stivarga is and what it is used for What you need to know before you take Stivarga How to take Stivarga
Slovenian: Kaj je zdravilo Stivarga in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Stivarga Kako jemati zdravilo Stivarga Možni neželeni učinki
English: Other medicines and Stivarga
Slovenian: Druga zdravila in zdravilo Stivarga
English: Both women of childbearing potential and men should use effective contraception during treatment and for at least eight weeks after completion of treatment.
Slovenian: Ženske v rodni dobi in moški morajo med zdravljenjem in še vsaj osem tednov po zaključenem zdravljenju uporabljati učinkovito kontracepcijsko metodo.
English: Bile saltsequestering agents such as cholestyramine and cholestagel may interact with regorafenib by forming insoluble complexes which may impact absorption (or reabsorption), thus resulting in potentially decreased exposure.
Slovenian: Adsorbenti žolčnih kislin, kot sta npr. holestiramin in holestagel, lahko medsebojno delujejo z regorafenibom tako, da tvorijo netopne komplekse, ki lahko vplivajo na absorpcijo (ali reabsorpcijo), in posledično zmanjšajo izpostavljenost regorafenibu.
English: Before you start taking Stivarga and during treatment your doctor will check how well your heart is working.
Slovenian: Preden začnete jemati zdravilo Stivarga in med zdravljenjem, bo zdravnik preverjal, kako deluje vaše srce.
English: Approximately 90% of the radioactive dose was recovered within 12 days after administration, with about 71% of the dose excreted in faeces (47% as parent compound, 24% as metabolites), and about 19% of the dose excreted in urine as glucuronides.
Slovenian: Približno 90 % radioaktivnega odmerka se je izločilo v 12 dneh po uporabi, pri čemer se je približno 71 % odmerka izločilo v blatu (47 % kot izhodna spojina, 24 % kot presnovki) in približno 19 % odmerka se je izločilo v seču v obliki glukuronidov.
English: An example of a light (low-fat) meal would include 1 portion of cereal (about 30 g), 1 glass of skimmed milk, 1 slice of toast with jam, 1 glass of apple juice, and 1 cup of coffee or tea (520 calories, 2 g fat).
Slovenian: Lahek obrok (z majhno vsebnostjo maščob) naj bi na primer vseboval 1 obrok kosmičev (približno 30 g), 1 kozarec posnetega mleka, 1 rezino opečenca z marmelado, 1 kozarec jabolčnega soka in 1 skodelico kave ali čaja (520 kalorij, 2 g maščobe).
English: Demographics and baseline disease characteristics were comparable between the Stivarga- and placebo-treated groups and are shown below for all 573 randomised patients:
Slovenian: Demografski podatki in osnovne značilnosti bolezni so bili primerljivi med skupino bolnikov, ki so bili zdravljeni z zdravilom Stivarga in skupino, ki je prejemala placebo in so prikazani spodaj za vseh 573 randomiziranih bolnikov:
English: These effects occurred at systemic exposures in the range of or below the anticipated human exposure (based on AUC comparison).
Slovenian: Ti učinki so se pojavili pri sistemski izpostavljenosti, v razponu, ki je bil enak ali manjši od pričakovane izpostavljenosti pri ljudeh (glede na primerjavo AUC).
English: You must not breast-feed your baby during Stivarga treatment, as this medicine may interfere with the growth and development of your baby.
Slovenian: Med zdravljenjem z zdravilom Stivarga ne smete dojiti, saj lahko to zdravilo vpliva na rast in razvoj vašega otroka.
English: If no improvement occurs despite dose reduction, interrupt therapy for a minimum of 7 days, until toxicity resolves to Grade 0-1.
Slovenian: Če kljub zmanjšanju odmerka ni izboljšanja, je treba zdravljenje prekiniti za vsaj 7 dni, dokler ni stopnja toksičnosti ponovno med 0 in 1.
English: The primary site of disease was colon (65%), rectum (29%), or both (6%).
Slovenian: Primarno mesto bolezni je bilo debelo črevo (65 %), danka (29 %) ali oboje (6 %).
English: For patients with observed worsening of liver function tests considered related to treatment with Stivarga (i.e. where no alternative cause is evident, such as post-hepatic cholestasis or disease progression), the dose modification and monitoring advice in Table 2 should be followed (see section 4.2).
Slovenian: Pri bolnikih z opaženim poslabšanjem izvidov preiskav delovanja jeter, za katera se meni, da so posledica zdravljenja z zdravilom Stivarga (tj. ko ni očitnega drugega vzroka, npr. posthepatična holestaza ali napredovanje bolezni), je treba upoštevati priporočila za spremembe odmerka in spremljanje v preglednici 2 (glejte poglavje 4.2).
English: - if you had or have any bleeding problems and if you are taking warfarin, phenprocoumon or another medicine that thins the blood to prevent blood clots.
Slovenian: - če ste imeli ali imate težave s krvavitvami in če jemljete varfarin, fenprokumon ali kakšno drugo zdravilo za redčenje ali preprečevanje strjevanja krvi.
English: These may be signs of severe stomach or bowel problems.
Slovenian: To so lahko znaki hudih težav v želodcu ali črevesju.
English: Patients with a history of ischaemic heart disease should be monitored for clinical signs and symptoms of myocardial ischaemia.
Slovenian: Bolnike z ishemično boleznijo srca v anamnezi je treba spremljati glede kliničnih znakov in simptomov miokardne ishemije.
English: Do not use this medicine after the expiry date which is stated on the carton and the bottle label after EXP.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli poleg oznake EXP. Rok uporabnosti zdravila se izteče na zadnji dan navedenega meseca.