FrancophonIA/ELRC3.0 huggingface dataset:
English: Not all of these effects have necessarily been linked to the use of these medicines; uncommon conditions affect fewer than 100 in 10,000 patients taking {PRODUCT NAME} (this means that for every 10,000 patients taking {PRODUCT NAME}, at least 9,900 are not expected to have these side effects).
Slovenian: Ni nujno, da so bili vsi ti neželeni učinki povezani z uporabo teh zdravil; občasni neželeni učinki se pojavijo pri manj kot 100 od 10.000 bolnikov, ki jemljejo {(Lastniško) ime} (to pomeni, da vsaj 9.900 od 10.000 bolnikov, ki jemljejo {(Lastniško) ime}, teh neželenih učinkov ne bo doživelo).
English: Do not take {PRODUCT NAME} 10 mg
Slovenian: Ne jemljite zdravila {(Lastniško) ime} 10 mg
English: Atorvastatin is eliminated primarily in bile following hepatic and/or extrahepatic metabolism.
Slovenian: Atorvastatin se po presnovi v jetrih in/ali zunaj jeter eliminira predvsem z žolčem.
English: Atorvastatin is metabolized by cytochrome P450 3A4.
Slovenian: Atorvastatin se presnavlja s citokromom P450 3A4.
English: MARKETING AUTHORISATION NUMBER(S) <[To be completed nationally]>
Slovenian: ŠTEVILKA DOVOLJENJA ZA PROMET [Izpolni država članica]
English: There are some medicines that may interact with {PRODUCT NAME}:
Slovenian: Uporaba drugih zdravil Nekatera zdravila imajo lahko z zdravilom {(Lastniško) ime} medsebojne učinke.
English: Fatal CHD plus non-fatal MI Total cardiovascular events and revascularization procedures Total coronary events
Slovenian: CHD s smrtnim izidom in MI brez smrtnega izida Skupno število ardiovaskularnih dogodkov in revaskularizacij Skupno število koronarnih dogodkov
English: − Other medicines known to interact with {PRODUCT NAME} include warfarin (which reduces blood clotting), oral contraceptives, phenytoin (an anti-convulsant for epilepsy), and antacids
Slovenian: − druga zdravila, ki imajo lahko z zdravilom {(Lastniško) ime} medsebojne učinke, so varfarin (zdravilo za zmanjševanje strjevanja krvi), peroralni kontraceptivi, fenitoin (antikonvulziv za zdravljenje epilepsije) ter antacidi (zdravila za zmanjšanje ravni želodčne kisline, ki vsebujejo aluminij ali magnezij)
English: Lowdensity lipoprotein (LDL) is formed from VLDL and is catabolized primarily through the receptor with high affinity to LDL (LDL receptor).
Slovenian: Razgradijo se predvsem prek receptorja z veliko afiniteto za LDL (receptor LDL).
English: Inhibitors of cytochrome P450 3A4
Slovenian: Zaviralci citokroma P450 3A4
English: Common: constipation, flatulence, dyspepsia, nausea, diarrhoea.
Slovenian: Pogosto: zaprtje, flatulenca, dispepsija, navzea, driska.
English: − Some calcium channel blockers used for angina or high blood pressure, e.g. nifedipine;
Slovenian: − nekatera zdravila iz skupine zaviralcev kalcijevih kanalčkov, ki se uporabljajo za zdravljenje angine pektoris ali zdravljenje visokega krvnega pritiska, npr. nifedipin; zdravila, ki uravnavajo vaš srčni ritem, npr. digoksin
English: They are marked with 80 on one side and PD158 on the other side.
Slovenian: Na eni strani imajo oznako "80" in na drugi strani oznako "PD 158".
English: Do not take {PRODUCT NAME} 80 mg
Slovenian: Ne jemljite zdravila {(Lastniško) ime} 80 mg
English: Patients were treated with either atorvastatin 10 mg daily (n=1428) or placebo (n=1410) for a median follow-up of 3.9 years.
Slovenian: Bolniki so bili zdravljeni z bodisi atorvastatinom 10 mg dnevno (n=1428) bodisi placebom (n=1410) v obdobju spremljanja z mediano 3,9 let.
English: Each {PRODUCT NAME} 20 mg film-coated tablet contains 65.61 mg lactose monohydrate.
Slovenian: Vsaka {(Lastniško) ime} 20 mg filmsko obložena tableta vsebuje 65.61 mg laktoze monohidrata.
English: Calcium carbonate Microcrystalline cellulose Lactose monohydrate Croscarmellose sodium Polysorbate 80
Slovenian: 6.1 Seznam pomožnih snovi kalcijev karbonat mikrokristalna celuloza laktoza monohidrat premreženi natrijev karmelozat polisorbat 80 hidroksipropilceluloza magnezijev stearat
English: Phenazone
Slovenian: Fenazon
English: Based on data from clinical studies and extensive post-marketing experience, the following table presents the adverse event profile for {PRODUCT NAME}.
Slovenian: Naslednja tabela prikazuje profil neželenih učinkov {(Lastniško) ime} na podlagi podatkov iz kliničnih raziskav in obsežnih postmarketinških izkušenj.
English: Blister packs containing 4, 7, 10, 14, 20, 28, 30, 50, 56, 84, 98 and 100 film-coated tablets.
Slovenian: Pretisni omoti s 4, 7, 10, 14, 20, 28, 30, 50, 56, 84, 98 in 100 filmsko obloženimi tabletami.
English: {PRODUCT NAME} is also indicated to reduce total-C and LDL-C in patients with homozygous familial hypercholesterolaemia as an adjunct to other lipid-lowering treatments (e.g. LDL apheresis) or if such treatments are unavailable.
Slovenian: {(Lastniško) ime} je indiciran tudi za znižanje zvišanega celotnega holesterola in holesterola LDL pri bolnikih s homozigotno obliko familiarne hiperholesterolemije kot dodatek drugim načinom terapevtskega zniževanja lipidov (npr. aferezi LDL) ali če takšni načini niso na voljo.
English: − Atorvastatin must be discontinued if clinically significant elevation of CPK levels (> 10 x ULN) occur, or if rhabdomyolysis is diagnosed or suspected.
Slovenian: - Če se pojavi klinično pomembno zvišanje CPK (> 10-kratna ZNM), če je diagnosticirana rabdomioliza, ali če obstaja sum nanjo, je treba uporabo atorvastatina prekiniti.
English: Gemfibrozil / fibric acid derivatives
Slovenian: Gemfibrozil/ fibrati
English: Inhibitors of the Pglycoprotein (e.g. ciclosporin) can increase the bioavailability of atorvastatin.
Slovenian: Atorvastatin in njegovi presnovki so substrati glikoproteina P. Zaviralci glikoproteina P (npr. ciklosporin) lahko zvečajo biološko uporabnost atorvastatina.
English: Background information on the type II variation through the MRP
Slovenian: Osnovni podatki o variaciji tipa II, ki so zbrani v postopkih medsebojnega priznavanja (MRP)
English: 83 vs. 127 38 vs 64 21 vs. 39 Based on difference in crude events rates occurring over a median follow-up of 3.9 years.
Slovenian: 38 v primerjavi s 21 v primerjavi s 1Na podlagi razlike med okvirnim številom dogodkov v povprečnem obdobju spremljanja 3,9 leta.
English: Each {PRODUCT NAME} 80 mg film-coated tablet contains 262.44 mg lactose monohydrate.
Slovenian: Vsaka {(Lastniško) ime} 80 mg filmsko obložena tableta vsebuje 262.44 mg laktoze monohidrata.
English: Common: asthenia, chest pain, back pain, peripheral oedema.
Slovenian: Pogosto: astenija, bolečine v prsih, bolečine v hrbtu, periferni edemi.
English: {PRODUCT NAME} is contraindicated in pregnancy and while breast feeding.
Slovenian: 4.6 Nosečnost in dojenje {(Lastniško) ime} je med nosečnostjo in dojenjem kontraindiciran.
English: They are marked with 20 on one side and PD156 on the other side.
Slovenian: Na eni strani imajo oznako "20" in na drugi strani oznako "PD 156".
English: Each {PRODUCT NAME} 10 mg film-coated tablet contains 32.80 mg lactose monohydrate.
Slovenian: Vsaka {(Lastniško) ime} 10 mg filmsko obložena tableta vsebuje 32.80 mg laktoze monohidrata.
English: You should tell your doctor immediately if it happens.
Slovenian: Če se pojavi, takoj obvestite svojega zdravnika.
English: Each {PRODUCT NAME} 40 mg film-coated tablet contains 131.22 mg lactose monohydrate.
Slovenian: Vsaka {(Lastniško) ime} 40 mg filmsko obložena tableta vsebuje 131.22 mg laktoze monohidrata.
English: Date:} which is stated on the container and outer packaging.
Slovenian: PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU Pretisni omot
English: No. of Events (Atorvastatin
Slovenian: Št. dogodkov (Sortis v prim.
English: The primary endpoint (fatal CHD plus non-fatal MI) was significantly reduced by atorvastatin in patients treated with Amlodipin (HR 0.47 (0.32-0.69)p=0.00008), but not in those treated with Atenolol (HR 0.83 (0.59-1.17 ), p= 0.287).
Slovenian: Primarni kazalec izida (koronarna srčna bolezen z miokardnim infarktom s smrtnim izidom) se je statistično značilno znižal z uporabo atorvastatina pri bolnikih, ki so se zdravili z amlodipinom (razmerje tveganja HR 0,47 (0,32-0,69), p=0,00008), vendar ne pri bolnikih, ki so se zdravili z atenololom (razmerje tveganja HR 0,83 (0,59-1,17), p=0,287).
English: The coating of {PRODUCT NAME} contains hypromellose, macrogol 8000, titanium dioxide (E171), talc, simeticone, macrogol stearate and sorbic acid.
Slovenian: Filmska obloga tablet {(Lastniško) ime} vsebuje hipromelozo, makrogol 8000, titanov dioksid (E171), smukec, simetikon, makrogol stearat in sorbinsko kislino.
English: Based on difference in crude events rates occurring over a median follow-up of 3.9 years.
Slovenian: Na osnovi razlike med neprilagojenimi stopnjami dogodkov v trajanju spremljanja z mediano 3,9 let.
English: They are marked with 40 on one side and PD157 on the other side.
Slovenian: Na eni strani imajo oznako "40" in na drugi strani oznako "PD 157".
English: How to take {PRODUCT NAME} 80 mg 4.
Slovenian: Kako jemati zdravilo {(Lastniško) ime} 80 mg 4.
English: diarrhoea, insomnia, dizziness, chest pain, allergic reactions, numbness, joint pain and back pain, asthenia, peripheral oedema, itching.
Slovenian: alergijske reakcije, odrevenelost, bolečine v sklepih in v hrbtu, telesna oslabelost, periferni edemi, srbenje.
English: The coating of {PRODUCT NAME}contains hypromellose, macrogol 8000, titanium dioxide (E171), talc, simeticone, macrogol stearate, sorbic acid and candelilla wax.
Slovenian: Filmska obloga tablet {(Lastniško) ime} vsebuje hipromelozo, makrogol 8000, titanov dioksid (E171), smukec, simetikon, makrogol stearat, sorbinsko kislino in kandelila vosek.
English: peripheral oedema (e.g. ankle swelling), hepatitis (liver inflammation), jaundice (yellowing of the skin and whites of the eyes), rhabdomyolysis (serious muscle pain and weakness, often associated with fever).
Slovenian: − Zmanjšana občutljivost kože na dotik ali bolečino, mišična oslabelost, mehurjasti izpuščaji po koži, periferni edemi (npr. otekanje gležnjev), hepatitis (vnetje jeter), zlatenica (rumeno obarvanje kože in očesne beločnice), rabdomioliza (hude bolečine v mišicah in šibkost, kar pogosto spremlja vročina)
English: HOW TO TAKE {PRODUCT NAME} 20 mg
Slovenian: KAKO JEMATI ZDRAVILO {(Lastniško) ime} 20 mg
English: White elliptical, film-coated tablets debossed "80" on one side and "PD 158" on the other.
Slovenian: Bela filmsko obložena tableta elipsaste oblike, ki ima na eni strani oznako "80" in na drugi strani oznako "PD 158".
English: The patient should be placed on a standard cholesterol-lowering diet before receiving {PRODUCT NAME} and should continue on this diet during treatment with {PRODUCT NAME}.
Slovenian: Pred začetkom zdravljenja s {(Lastniško) ime} je treba bolniku predpisati standardno dieto za znižanje holesterola, ki jo mora nadaljevati tudi med zdravljenjem s {(Lastniško) ime}.
English: How to take {PRODUCT NAME}40 mg 4.
Slovenian: Kako jemati zdravilo {(Lastniško) ime} 40 mg 4.
English: How to store {PRODUCT NAME} 40 mg 6.
Slovenian: Shranjevanje zdravila {(Lastniško) ime} 40 mg 6.
English: to reduce total-C and LDL-C in patients with homozygous familial hypercholesterolemia an adjunct to other lipid-lowering treatments (e.g. LDL apheresis) or if such treatments are unavailable.
Slovenian: za znižanje skupne ravni holesterola in LDL-holesterola pri bolnikih s homozigotno družinsko hiperholesterolemijo kot dopolnilo k drugim vrstam zdravljenja za znižanje ravni lipidov v krvi (npr. LDL-afereza), ali kadar druge vrste zdravljenja niso na voljo.
English: What {PRODUCT NAME} 40 mg is and what it is used for 2.
Slovenian: Kaj je zdravilo {(Lastniško) ime} 40 mg in za kaj ga uporabljamo 2.
English: How to store {PRODUCT NAME} 80 mg 6.
Slovenian: Shranjevanje zdravila {(Lastniško) ime} 80 mg 6.
English: They are marked with 10 on one side and PD155 on the other side.
Slovenian: Na eni strani imajo oznako "10" in na drugi strani oznako "PD 155".
English: HOW TO TAKE {PRODUCT NAME} 10 mg
Slovenian: KAKO JEMATI ZDRAVILO {(Lastniško) ime} 10 mg
English: In the MIRACL study, atorvastatin 80 mg has been evaluated in 3,086 patients (atorvastatin n=1,538; placebo n=1,548) with an acute coronary syndrome (non Q-wave MI or unstable angina).
Slovenian: V raziskavi MIRACL so pri 3086 bolnikih (atorvastatin n=1538; placebo n=1548) z akutnim koronarnim sindromom (miokardni infarkt brez zobca Q in nestabilna angina pektoris) ovrednotili zdravljenje z atorvastatinom 80 mg. Z zdravljenjem so pričeli med akutno fazo po sprejemu v bolnišnico in je trajalo 16 tednov.
English: 1Based on difference in crude events rates occurring over a median follow-up of 3.3 years.
Slovenian: 1Na osnovi razlike med neprilagojenimi stopnjami dogodkov v trajanju spremljanja z mediano 3,3 let.
English: When multiple doses of digoxin and 10 mg atorvastatin were coadministered, steady-state plasma digoxin concentrations were unaffected.
Slovenian: Med sočasno uporabo večkratnih odmerkov digoksina in 10 mg atorvastatina se koncentracija digoksina v stanju dinamičnega ravnovesja ni spremenila, med uporabo digoksina in 80 mg atorvastatina na dan pa se je zvečala za približno 20%.
English: Thereafter, either the dose may be increased to a maximum of 80 mg daily or a bile acid sequestrant may be combined with 40 mg atorvastatin once daily.
Slovenian: Zdravljenje je treba začeti z 10 mg {(Lastniško) ime} na dan. Odmerke je treba določiti posamezno in jih prilagajati vsake 4 tedne, do odmerka 40 mg na dan. Potem je mogoče bodisi zvečati odmerek do največ 80 mg na dan bodisi atorvastatin v odmerku 40 mg uporabiti v kombinaciji z adsorbentom žolčnih kislin.
English: What {PRODUCT NAME} 80 mg is and what it is used for 2.
Slovenian: Kaj je zdravilo {(Lastniško) ime} 80 mg in za kaj ga uporabljamo 2.
English: WHAT {PRODUCT NAME} 10 mg IS AND WHAT IT IS USED FOR
Slovenian: KAJ JE ZDRAVILO {(Lastniško) ime} 10 mg IN ZA KAJ GA UPORABLJAMO
English: Ear and Labyrinth Disorders
Slovenian: Ušesne bolezni, vključno z motnjami labirinta
English: White elliptical, film-coated tablets debossed "40" on one side and "PD 157" on the other.
Slovenian: Bela filmsko obložena tableta elipsaste oblike, ki ima na eni strani oznako "40" in na drugi strani oznako "PD 157".
English: What {PRODUCT NAME} 20 mg contains
Slovenian: Kaj vsebuje zdravilo {(Lastniško) ime} 20 mg
English: Before you take {PRODUCT NAME} 80 mg 3.
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo {(Lastniško) ime} 80 mg 3.
English: Concomitant intake of large quantities of grapefruit juice and atorvastatin is therefore not recommended.
Slovenian: Zato ni priporočljivo, da bolnik med jemanjem atorvastatina pije veliko grenivkinega soka.
English: Before you take {PRODUCT NAME} 40 mg 3.
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo {(Lastniško) ime} 40 mg 3.
English: The maximum dose of {PRODUCT NAME}is 80 mg once daily.
Slovenian: Največji odmerek je 80 mg {(Lastniško) ime} enkrat na dan.
English: PHARMACEUTICAL PARTICULARS
Slovenian: 6 FARMACEVTSKI PODATKI
English: Always take {PRODUCT NAME} 80 mg exactly as your doctor has told you.
Slovenian: Pri jemanju zdravila {(Lastniško) ime} 80 mg vedno natančno upoštevajte zdravnikova navodila.
English: INFORMATION IN BRAILLE {PRODUCT NAME} 10 mg Film-coated tablets
Slovenian: PODATKI V BRAILLOVI PISAVI {(Lastniško) ime} 10 mg filmsko obložene tablete
English: The duration of treatment with {PRODUCT NAME} 80 mg is determined by your doctor.
Slovenian: Trajanje zdravljenja s {(Lastniško) ime} 80 mg bo določil zdravnik.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING BLISTER PACK CARTON (for blisters of 4, 7, 10, 14, 20, 28, 30, 50, 56, 84, 98, 100 tablets) HOSPITAL PACK LABEL (for blisters of 200 & 500 tablets)
Slovenian: PODATKI NA ZUNANJI OVOJNINI Škatla (za pretisne omote s 4, 7, 10, 14, 20, 28, 30, 50, 56, 84, 98, 100 tabletami) Nalepka za bolnišnično pakiranje (za pretisne omote z 200 in 500 tabletami)
English: Hypromellose Polyethylene glycol Titanium dioxide (E171) Talc
Slovenian: hipromeloza polietilenglikol titanov dioksid (E171) smukec simetikon stearatni emulgatorji sorbinska kislina
English: WHAT {PRODUCT NAME} 80 mg IS AND WHAT IT IS USED FOR
Slovenian: KAJ JE ZDRAVILO {(Lastniško) ime} 80 mg IN ZA KAJ GA UPORABLJAMO
English: Do not take {PRODUCT NAME} if you are breast-feeding.
Slovenian: Če dojite, ne smete jemati zdravila {(Lastniško) ime}.
English: The duration of treatment with {PRODUCT NAME} 40 mg is determined by your doctor.
Slovenian: Trajanje zdravljenja s {(Lastniško) ime} 40 mg bo določil zdravnik.
English: WHAT {PRODUCT NAME} 40 mg IS AND WHAT IT IS USED FOR
Slovenian: KAJ JE ZDRAVILO {(Lastniško) ime} 40 mg IN ZA KAJ GA UPORABLJAMO
English: The development of rat offspring was delayed and post-natal survival reduced during exposure of the dams to atorvastatin at doses above 20 mg/kg/day (the clinical systemic exposure).
Slovenian: Če so breje samice dobivale atorvastatin v odmerkih nad 20 mg/kg/dan (klinična sistemska izpostavljenost), je bil razvoj mladičev upočasnjen, preživetje neposredno po rojstvu pa manjše.
English: What {PRODUCT NAME} 10 mg contains
Slovenian: Kaj vsebuje zdravilo {(Lastniško) ime} 10 mg
English: HOW TO TAKE {PRODUCT NAME} 80 mg
Slovenian: KAKO JEMATI ZDRAVILO {(Lastniško) ime} 80 mg
English: Always take {PRODUCT NAME} 20 mg exactly as your doctor has told you.
Slovenian: Pri jemanju zdravila {(Lastniško) ime} 20 mg vedno natančno upoštevajte zdravnikova navodila.
English: What {PRODUCT NAME} 80 mg contains
Slovenian: Kaj vsebuje zdravilo {(Lastniško) ime} 80 mg
English: The duration of treatment with {PRODUCT NAME} 20 mg is determined by your doctor.
Slovenian: Trajanje zdravljenja s {(Lastniško) ime} 20 mg bo določil zdravnik.
English: The duration of treatment with {PRODUCT NAME} 10 mg is determined by your doctor.
Slovenian: Trajanje zdravljenja s {(Lastniško) ime} 10 mg bo določil zdravnik.
English: INFORMATION IN BRAILLE {PRODUCT NAME} 80 mg Film-coated tablets
Slovenian: PODATKI V BRAILLOVI PISAVI {(Lastniško) ime} 80 mg filmsko obložene tablete
English: 38 vs 64
Slovenian: 83 v primerjavi s
English: Always take {PRODUCT NAME} 40 mg exactly as your doctor has told you.
Slovenian: Pri jemanju zdravila {(Lastniško) ime} 40 mg vedno natančno upoštevajte zdravnikova navodila.
English: WHAT {PRODUCT NAME} 20 mg IS AND WHAT IT IS USED FOR
Slovenian: KAJ JE ZDRAVILO {(Lastniško) ime} 20 mg IN ZA KAJ GA UPORABLJAMO
English: See Section 2 “Take special care with {PRODUCT NAME} 20 mg” for details.
Slovenian: Za podrobnosti glejte poglavje 2 "Bodite posebno pozorni pri jemanju zdravila {(Lastniško) ime} 20 mg".
English: See Section 2 “Take special care with {PRODUCT NAME} 80 mg” for details.
Slovenian: Za podrobnosti glejte poglavje 2 "Bodite posebno pozorni pri jemanju zdravila {(Lastniško) ime} 80 mg".
English: INFORMATION IN BRAILLE {PRODUCT NAME} 20 mg Film-coated tablets
Slovenian: PODATKI V BRAILLOVI PISAVI {(Lastniško) ime} 20 mg filmsko obložene tablete
English: Always take {PRODUCT NAME} 10 mg exactly as your doctor has told you.
Slovenian: Pri jemanju zdravila {(Lastniško) ime} 10 mg vedno natančno upoštevajte zdravnikova navodila.
English: What {PRODUCT NAME} 40 mg contains
Slovenian: Kaj vsebuje zdravilo {(Lastniško) ime} 40 mg
English: White elliptical, film-coated tablets debossed "20" on one side and "PD 156" on the other.
Slovenian: Bela filmsko obložena tableta elipsaste oblike, ki ima na eni strani oznako "20" in na drugi strani oznako "PD 156".
English: INFORMATION IN BRAILLE {PRODUCT NAME} 40 mg Film-coated tablets
Slovenian: PODATKI V BRAILLOVI PISAVI {(Lastniško) ime} 40 mg filmsko obložene tablete
English: White elliptical, film-coated tablets debossed "10" on one side and "PD 155" on the other.
Slovenian: Bela filmsko obložena tableta elipsaste oblike, ki ima na eni strani oznako "10" in na drugi strani oznako "PD 155".
English: A therapeutic response is evident within 2 weeks, and the maximum therapeutic response is usually achieved within 4 weeks.
Slovenian: Primarna hiperholesterolemija in kombinirana (mešana) hiperlipidemija Pri večini bolnikov se stanje uredi z 10 mg {(Lastniško) ime} enkrat na dan. Terapevtski odziv je opazen že v 2 tednih, največji odziv pa se ponavadi pokaže v 4 tednih.
English: Common conditions, affect at least 100 in 10,000 patients taking {PRODUCT NAME} (this means that for every 10,000 patients, up to 9,900 are not expected to have these side effects).
Slovenian: Pogosti neželeni učinki se pojavijo pri vsaj 100 od 10.000 bolnikov, ki jemljejo {(Lastniško) ime} (to pomeni, da do 9.900 od 10.000 bolnikov, ki jemljejo {(Lastniško) ime}, teh neželenih učinkov ne bo doživelo).
English: HOW TO TAKE {PRODUCT NAME} 40 mg
Slovenian: KAKO JEMATI ZDRAVILO {(Lastniško) ime} 40 mg
English: Do not use {PRODUCT NAME} 80 mg if you notice visible signs of deterioration.
Slovenian: Ne uporabljajate zdravila {(Lastniško) ime} 80 mg, če opazite vidne znake kvarjenja.
English: 21 vs. 39
Slovenian: 38 napram21 napram
English: Do not use {PRODUCT NAME} 80 mg after the expiry date {Exp.
Slovenian: Zdravila {(Lastniško) ime} 80 mg ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na ovojnini.
English: What {PRODUCT NAME} 80 mg looks like and contents of the pack {PRODUCT NAME} film-coated tablets are white with an oval shape.
Slovenian: Izgled zdravila {(Lastniško) ime} 80 mg in vsebina pakiranja {(Lastniško) ime} 80 mg filmsko obložene tablete so bele in ovalne oblike.
English: Psychiatric
Slovenian: Psihiatrične motnje
English: − Renal impairment
Slovenian: Bolezni prebavil
English: Take special care with {PRODUCT NAME} 20 mg The following are reasons why {PRODUCT NAME} may not be suitable for you:
Slovenian: Bodite posebno pozorni pri jemanju zdravila {(Lastniško) ime} 20 mg {(Lastniško) ime} za vas morda ni primeren zaradi naslednjih razlogov:
English: Adjustment of dosage should be made at intervals of 4 weeks or more.
Slovenian: Običajni začetni odmerek je 10 mg enkrat na dan. Odmerjanje je treba prilagajati v presledku 4 tednov ali več.
English: − Nausea, abdominal pain, constipation, wind, indigestion, headache, muscle pain, weakness,
Slovenian: glavobol, bolečine v mišicah, šibkost, driska, nespečnost, vrtoglavica, bolečine v prsih,
English: Take special care with {PRODUCT NAME} 80 mg The following are reasons why {PRODUCT NAME} may not be suitable for you:
Slovenian: Bodite posebno pozorni pri jemanju zdravila {(Lastniško) ime} 80 mg {(Lastniško) ime} za vas morda ni primeren zaradi naslednjih razlogov:
English: Special populations
Slovenian: Splošne težave
English: Do not use {PRODUCT NAME} 20 mg after the expiry date {Exp.
Slovenian: Zdravila {(Lastniško) ime} 20 mg ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na ovojnini.
English: Do not use {PRODUCT NAME} 20 mg if you notice visible signs of deterioration.
Slovenian: Ne uporabljajate zdravila {(Lastniško) ime} 20 mg, če opazite vidne znake kvarjenja.
English: Do not use {PRODUCT NAME} 40 mg after the expiry date {Exp.
Slovenian: Zdravila {(Lastniško) ime} 40 mg ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na ovojnini.
English: Do not use {PRODUCT NAME} 10 mg after the expiry date {Exp.
Slovenian: Zdravila {(Lastniško) ime} 10 mg ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na ovojnini.
English: Rare conditions affect fewer than 10 in 10,000 patients taking {PRODUCT NAME} (this means that for every 10,000 patients taking {PRODUCT NAME}, at least 9,990 are not expected to have these side effects).
Slovenian: Redki neželeni učinki se pojavijo pri manj kot 10 od 10.000 bolnikov, ki jemljejo {(Lastniško) ime} (to pomeni, da vsaj 9.990 od 10.000 bolnikov, ki jemljejo {(Lastniško) ime}, teh neželenih učinkov ne bo doživelo).
English: Like all medicines, {PRODUCT NAME} 80 mg can cause side effects, although not everybody gets them.
Slovenian: Kot vsa zdravila ima lahko tudi zdravilo {(Lastniško) ime} 80 mg neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
English: See Section 2 “Take special care with {PRODUCT NAME} 10 mg” for details
Slovenian: Za podrobnosti glejte poglavje 2 "Bodite posebno pozorni pri jemanju zdravila {(Lastniško) ime} 10 mg".