FrancophonIA/ELRC3.0 huggingface dataset:
English: − Situations where an increase in plasma levels may occur, such as interactions (see section 4.5) and special populations including genetic subpopulations (see section 5.2)
Slovenian: - v primerih, ko lahko pride do povišanja plazemskega nivoja, kot so medsebojno delovanje (glejte poglavje 4.5).ali posebne populacije, vključno z genetskimi subpopulacijami (glejte poglavje 5.2).
English: Efficacy and safety in patients older than 70 using recommended doses are similar to those seen in the general population.
Slovenian: Pri bolnikih, starejših od 70 let, sta učinkovitost in varnost zdravila v priporočenih odmerkih podobna kot pri splošni populaciji.
English: Not all included patients were estimated to have a high risk for a first cardiovascular event.
Slovenian: Niso ocenili, da pri vseh vključenih bolnikih obstaja visoko tveganje za prvi srčnožilni dogodek.
English: The safety of {PRODUCT NAME} during pregnancy and breast-feeding has not yet been proven.
Slovenian: Varnost uporabe zdravila {(Lastniško) ime} med nosečnostjo in dojenjem še ni bila dokazana.
English: Your doctor will adapt the dose at intervals of 4 weeks or more.
Slovenian: Zdravnik bo odmerek prilagajal v presledku štirih tednov ali več.
English: Avoid drinking too much alcohol while taking this medicine.
Slovenian: Med jemanjem tega zdravila se izogibajte pitju večjih količin alkohola.
English: In such situations, the risk of treatment should be considered in relation to possible benefit, and clinical monitoring is recommended.
Slovenian: V takšnih okoliščinah je treba tveganje zdravljenja pretehtati v primerjavi z možnimi koristmi; priporočljivo je klinično nadziranje.
English: The safety and tolerability profiles of the two treatment groups were comparable.
Slovenian: Kar zadeva varnost in prenašanje obeh zdravil, sta bili skupini primerljivi.
English: • unexpected bleeding or bruising
Slovenian: • nepričakovano krvavenje in podplutbe,
English: In the atorvastatin group (n=253), there was no progression of atherosclerosis.
Slovenian: V skupini z atorvastatinom (n = 253) ateroskleroza ni napredovala.
English: Intake of one 240 ml glass of grapefruit juice also resulted in a decreased AUC of 20.4% for the active orthohydroxy metabolite.
Slovenian: Vnos enega 240 ml kozarca grenivkinega soka je povzročil tudi 20,4 % zmanjšanje AUC aktivnega ortohidroksi presnovka.
English: Normally this medicine does not affect your ability to drive or operate machines.
Slovenian: Običajno to zdravilo ne vpliva na vašo sposobnost, da vozite ali upravljate orodja ali stroje.
English: Patients should be closely monitored and temporary suspension of atorvastatin treatment may be appropriate.
Slovenian: Bolnike je treba skrbno spremljati in morda bo potrebna začasna prekinitev zdravljenja z atorvastatinom.
English: • gynecomastia (breast enlargement in men and women).
Slovenian: • ginekomastija (povečanje prsi pri moških in pri ženskah)
English: WHAT {PRODUCT NAME} IS AND WHAT IT IS USED FOR
Slovenian: KAJ JE ZDRAVILO {(LASTNIŠKO) IME} IN ZA KAJ GA UPORABLJAMO
English: Apart from other pathways these products are further metabolized via glucuronidation.
Slovenian: Poleg drugih poti poteka nadaljnja presnova teh produktov tudi z glukuronidacijo.
English: 83 vs. 127
Slovenian: 83 v primerjavi s 127
English: The increased risk was particularly noted in patients with prior hemorrhagic stroke or lacunar infarct at study entry.
Slovenian: Večje tveganje je bilo zlasti opazno pri bolnikih s predhodno hemoragično možgansko kapjo ali lakunarnim infarktom pri vstopu v študijo.
English: Experience in paediatrics is limited to a small number of patients (age 4 - 17 years) with severe dyslipidemias, such as homozygous familial hypercholesterolemia.
Slovenian: Izkušnje z uporabo pri otrocih so omejene na maloštevilne bolnike (stare od 4 do 17 let) s hudimi dislipidemijami, npr. s homozigotno familiarno hiperholesterolemijo.
English: Note: This SPC, labelling and packages leaflet is the version valid at the time of Commission decision.
Slovenian: Opomba: Ta različica povzetka glavnih značilnosti zdravila, označevanja in navodila za uporabo je različica, ki je v veljavi v času sprejema odločbe Komisije.
English: Belgium, Cyprus, Finland, Greece, Ireland, Luxembourg, Malta, Netherlands, Norway, Sweden, UK
Slovenian: Belgija, Ciper, Finska, Grčija, Irska, Luksemburg, Malta, Nizozemska, Norveška, Švedska, Združeno kraljevstvo
English: If you take more {PRODUCT NAME} than you should If you accidently take too many {PRODUCT NAME} tablets (more than your usual daily dose), contact your doctor or nearest hospital for advice.
Slovenian: Če ste vzeli večji odmerek zdravila {(Lastniško) ime} , kot bi smeli Če ste pomotoma vzeli preveč tablet (več kot znaša vaš običajni dnevni odmerek), se za nasvet obrnite na svojega zdravnika ali najbližjo bolnišnico.
English: Paediatric: Pharmacokinetic data in the paediatric population are not available.
Slovenian: Otroci: Farmakokinetičnih podatkov za pediatrično populacijo ni.
English: Estimated frequencies of reactions are ranked according to the following convention: common (≥ 1/100, < 1/10); uncommon (≥ 1/1,000, < 1/100); rare (≥ 1/10,000, < 1/1,000); very rare (≤ 1/10,000).
Slovenian: Ocenjene pogostnosti neželenih učinkov so po dogovoru razvrščene, kot sledi: pogosti (≥ 1/100, < 1/10); občasni (≥ 1/1.000, < 1/100); redki (≥ 1/10.000, < 1/1.000); zelo redki (≤ 1/10.000).
English: Creatine kinase (CK) should not be measured following strenuous exercise or in the presence of any plausible alternative cause of CK increase as this makes value interpretation difficult.
Slovenian: Kreatin kinaze (CK) ne smemo meriti po naporni telesni dejavnosti ali v prisotnosti drugih verjetnih vzrokov za zvišanje CK, kajti v takšnem primeru je tolmačenje vrednosti težavno.
English: The other secondary endpoints did not reach statistical significance on their own (overall: Placebo: 22.2%, Atorvastatin: 22.4%).
Slovenian: Ostali sekundarni opazovani dogodki sami niso bili statistično pomembni (skupno: placebo 22,2 %, atorvastatin
English: If you forget to take {PRODUCT NAME}
Slovenian: Če ste pozabili vzeti zdravilo {(Lastniško) ime}
English: The duration of treatment with {PRODUCT NAME} is determined by your doctor.
Slovenian: Trajanje zdravljenja z zdravilom {(Lastniško) ime} bo določil zdravnik.
English: Liver function tests should be performed before the initiation of treatment and periodically thereafter.
Slovenian: Laboratorijske preiskave jetrne funkcije je treba narediti pred začetkom zdravljenja in jih redno izvajati med zdravljenjem.
English: Prevention of cardiovascular events in patients estimated to have a high risk for a first cardiovascular event (see section 5.1), as an adjunct to correction of other risk factors.
Slovenian: Preprečevanje srčnožilnih dogodkov pri bolnikih, za katere so ocenili, da pri njih obstaja visoko tveganje za prvi srčnožilni dogodek (glejte poglavje 5.1), kot dodatek k obvladovanju ostalih dejavnikov tveganja.
English: Patients taking digoxin should be monitored appropriately.
Slovenian: Bolnike, ki jemljejo digoksin, je treba ustrezno spremljati.
English: Should an overdose occur, the patient should be treated symptomatically and supportive measures instituted, as required.
Slovenian: V primeru prevelikega odmerjanja, je treba bolnika zdraviti simptomatsko in uvesti podporne ukrepe, kot je potrebno.
English: Atorvastatin should be prescribed with caution in patients with pre-disposing factors for rhabdomyolysis.
Slovenian: Atorvastatin je treba previdno dajati bolnikom, ki imajo predispozicijske dejavnike za rabdomiolizo.
English: 21 vs. 39
Slovenian: 21 v primerjavi s 39
English: {PRODUCT NAME} should be used with caution in patients who consume substantial quantities of alcohol and/or have a history of liver disease.
Slovenian: Zdravilo {(Lastniško) ime} je treba previdno uporabljati pri bolnikih, ki uživajo veliko alkohola in/ali imajo anamnezo bolezni jeter.
English: Paediatric use
Slovenian: Pediatrična uporaba
English: Mean plasma elimination half-life of atorvastatin in humans is approximately 14 hours.
Slovenian: Povprečni razpolovni čas izločanja atorvastatina pri ljudeh je približno 14 ur.
English: There is evidence from animal experimental studies that HMG-CoA reductase inhibitors may affect the development of embryos or fetuses.
Slovenian: Izsledki študij na živalih kažejo, da lahko zaviralci reduktaze HMG-CoA vplivajo na razvoj zarodka oz. ploda.
English: Like all medicines, {PRODUCT NAME} can cause side effects, although not everybody gets them.
Slovenian: Kot vsa zdravila ima lahko tudi zdravilo {(Lastniško) ime} neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
English: Oral contraceptive OD, 2 months - norethindrone 1 mg -ethinyl estradiol 35 µg
Slovenian: Peroralni kontraceptiv enkrat na dan, 2 meseca - noretindron 1 mg - etinlestradiol 35 µg
English: • increases in blood sugar levels (if you have diabetes continue careful monitoring of your blood sugar levels), increase in blood creatine kinase
Slovenian: • zvišana raven sladkorja v krvi (če imate sladkorno bolezen, morate še naprej skrbno kontrolirati raven krvnega sladkorja), povišanje kreatin kinaze v krvi
English: In rats, rabbits and dogs atorvastatin had no effect on fertility and was not teratogenic, however, at maternally toxic doses fetal toxicity was observed in rats and rabbits.
Slovenian: Pri podganah, kuncih in psih atorvastatin ni imel nobenega vpliva na plodnost in ni bil teratogen, vendar so pri odmerkih toksičnih za mater ugotovili toksičnost pri podganah in kuncih.
English: Stroke Prevention by Aggressive Reduction in Cholesterol Levels (SPARCL)
Slovenian: Študija SPARCL (Stroke Prevention by Aggressive Reduction in Cholesterol Levels)
English: This may be increased if necessary by your doctor until you are taking the amount you need.
Slovenian: Zdravnik vam lahko predpiše višji odmerek, dokler ne boste dobivali odmerka, ki ga potrebujete.
English: If the dose of atorvastatin is changed or discontinued, the same procedure should be repeated.
Slovenian: Če se odmerek atorvastatina spremeni ali atorvastatin ukinemo, je treba celoten postopek ponoviti.
English: Atherosclerosis is a chronic process, and ordinarily discontinuation of lipidlowering medicinal products during pregnancy should have little impact on the long-term risk associated with primary hypercholesterolaemia.
Slovenian: Ateroskleroza je kronični proces in običajno ima prekinitev zdravljenja z zdravili za zniževanje lipidov med nosečnostjo le malo vpliva na dolgoročno tveganje povezano s primarno hiperholesterolemijo.
English: The absolute bioavailability of atorvastatin is approximately 12% and the systemic availability of HMGCoA reductase inhibitory activity is approximately 30%.
Slovenian: Absolutna biološka uporabnost atorvastatina je približno 12 %, sistemska uporabnost zaviralnega delovanja na HMG CoA reduktazo pa približno 30 %.
English: See sections 4.4 and 4.5 for clinical significance.
Slovenian: # Za klinični pomen glejte poglavji 4.4 in 4.5.
English: When compared to pravastatin the effects of atorvastatin were statistically significant (p=0.02).
Slovenian: Učinki atorvastatina so bili v primerjavi z učinki pravastatina statistično pomembni (p = 0,02).
English: Rare: cholestasis.
Slovenian: Redko: holestaza
English: A genetically impaired hepatic uptake of atorvastatin is also possible in these patients.
Slovenian: Genska okvara jetrnega privzema atorvastatina je možna tudi pri teh bolnikih.
English: In the subgroup analyses by gender (81% males, 19% females), a beneficial effect of atorvastatin was seen in males but could not be established in females possibly due to the low event rate in the female subgroup.
Slovenian: V analizi podskupin po spolu (81 % moških, 19 % žensk) so ugoden učinek atorvastatina na glavni opazovani dogodek potrdili pri moških, ne pa tudi pri ženskah, verjetno zato, ker je bila pogostost dogodkov v ženski podskupini manjša.
English: The dose of atorvastatin in patients with homozygous familial hypercholesterolemia is 10 to 80 mg daily (see section 5.1).
Slovenian: Odmerek atorvastatina pri bolnikih s homozigotno familiarno hiperholesterolemijo je od 10 do 80 mg na dan (glejte poglavje 5.1).
English: Elderly: Plasma concentrations of atorvastatin and its active metabolites are higher in healthy elderly subjects than in young adults while the lipid effects were comparable to those seen in younger patient populations.
Slovenian: Starejši: Koncentracija atorvastatina in njegovih aktivnih presnovkov v plazmi je pri zdravih starejših osebah večja kot pri mladih odraslih, učinki na lipide pa so primerljivi tistim pri mlajših bolnikih.
English: Taking {PRODUCT NAME} with food and drink See Section 3 for instructions on how to take {PRODUCT NAME}.
Slovenian: Jemanje zdravila {(Lastniško) ime} skupaj s hrano in pijačo Za navodila, kako jemati zdravilo {(Lastniško) ime}, glejte poglavje 3.
English: No adjustment of dose is required (see section 4.4).
Slovenian: Odmerka ni treba prilagajati (glejte poglavje 4.4).
English: It is possible that the net risk of stroke is increased in patients with prior lacunar infarct who receive atorvastatin 80 mg/day.
Slovenian: Mogoče je, da je neto tveganje za možgansko kap večje pri bolnikih s predhodnim lakunarnim infarktom, ki dobivajo 80 mg atorvastatina na dan.
English: Patients with rare hereditary problems of galactose intolerance, Lapp lactose deficiency or glucose-galactose malabsorption should not take this medicine.
Slovenian: Bolniki z redko dedno intoleranco za galaktozo, laponsko obliko zmanjšane aktivnosti laktaze ali malabsorpcijo glukoze/galaktoze ne smejo jemati tega zdravila.
English: In a multicenter 8 week open-label compassionate-use study with an optional extension phase of variable length, 335 patients were enrolled, 89 of which were identified as homozygous familial hypercholesterolaemia patients.
Slovenian: V multicentrično 8-tedensko odprto študijo sočutne uporabe z možnim podaljšanim obdobjem variabilne dolžine, je bilo vključenih 355 bolnikov, od teh so pri 89 bolnikih določili, da so oboleli za homozigotno familiarno hiperholesterolemijo.
English: Taking other medicines
Slovenian: Uporaba drugih zdravil
English: Atorvastatin reduces LDL production and the number of LDL particles.
Slovenian: Atorvastatin zmanjša nastajanje LDL in število LDL delcev v obtoku.
English: Polymorphism in the gene encoding OATP1B1 (SLCO1B1 c.521CC) is associated with a 2.4-fold higher atorvastatin exposure (AUC) than in individuals without this genotype variant (c.521TT).
Slovenian: Polimorfizem gena, ki kodira OATP1B1 (SLCO1B1 c.521CC) je povezan z 2,4-kratno višjo izpostavljenostjo atorvastatinu (AUC) kot pri posameznikih brez te variante genotipa (c.521TT).
English: All patients had at least 1 of the following risk factors: hypertension, current smoking, retinopathy, microalbuminuria or macroalbuminuria.
Slovenian: Vsi bolniki so imeli vsaj enega od naslednjih dejavnikov tveganja: hipertenzija, kajenje v času preskušanja, retinopatija, mikroalbuminurija ali makroalbuminurija.
English: The development of the rat offspring was delayed and post-natal survival reduced during exposure of the dams to high doses of atorvastatin.
Slovenian: Razvoj pri podganjih mladičih je bil zakasnel, preživetje po rojstvu pa se je zmanjšalo med izpostavljenostjo samic velikim odmerkov atorvastatina.
English: The effect of rifampin on atorvastatin concentrations in hepatocytes is, however, unknown and if concomitant administration cannot be avoided, patients should be carefully monitored for efficacy.
Slovenian: Vendar pa je učinek rifampina na koncentracije atorvastatina v hepatocitih neznan, tako da je potrebno bolnika, kadar se sočasni uporabi ne moremo izogniti, skrbno spremljati glede učinkovitosti.
English: * Contains one or more components that inhibit CYP3A4 and can increase plasma concentrations of medicinal products metabolized by CYP3A4.
Slovenian: * Vsebuje eno ali več sestavin, ki zavira CYP3A4 in lahko zviša plazemsko koncentracijo zdravil, ki se presnavljajo s CYP3A4.
English: The effect of intensive lipid lowering on major cardiovascular endpoints was not investigated in this study.
Slovenian: Učinek intenzivnega znižanja lipidov na glavne srčnožilne opazovane dogodke v tej študiji ni bil raziskan.
English: Because of the potential for serious adverse reactions, women taking {PRODUCT NAME} should not breast-feed their infants (see section 4.3).
Slovenian: Zaradi možnosti resnih neželenih učinkov, ženske, ki jemljejo zdravilo {(Lastniško) ime}, ne smejo dojiti svojih otrok (glejte poglavje 4.3).
English: Each daily dose of atorvastatin is given all at once and may be given at any time of day with or without food.
Slovenian: Dnevni odmerek je treba zaužiti naenkrat, kadarkoli čez dan, s hrano ali brez nje.
English: • urine tests that are positive for white blood cells
Slovenian: • pozitiven izvid preiskave urina za bele krvne celice.
English: This was mainly due to a 26% reduction in re-hospitalisation for angina pectoris with evidence of myocardial ischaemia (p=0.018).
Slovenian: Razlog za to je bilo predvsem 26-odstotno zmanjšanje števila ponovnih hospitalizacij zaradi angine pektoris z znaki ishemije miokarda (p = 0,018).
English: • anorexia (loss of appetite), weight gain, decreases in blood sugar levels (if you have diabetes you should continue careful monitoring of your blood sugar levels)
Slovenian: • anoreksija (izguba apetita), pridobivanje telesne mase, upadanje ravni sladkorja v krvi (če imate sladkorno bolezen, morate še naprej skrbno spremljati raven sladkorja v krvi),
English: A favourable trend was observed regarding the mortality rate (82 deaths in the placebo group vs. 61 deaths in the atorvastatin group, p=0.0592).
Slovenian: Opažen je bil ugoden trend glede na stopnjo smrtnosti (82 smrti v skupini s placebom, 61 smrti v skupini z atorvastatinom, p = 0,0592).
English: Overall and cardiovascular mortality were numerically higher in the female patients (38 vs. 30 and 17 vs. 12), but this was not statistically significant.
Slovenian: Celotna umrljivost in srčnožilna umrljivost sta bili številčno večji pri ženskah (38 v primerjavi s 30 in 17 v primerjavi z 12), vendar to ni bilo statistično pomembno.
English: • hepatitis (liver inflammation)
Slovenian: • hepatitis (vnetje jeter),
English: Creatine kinase measurement
Slovenian: Merjenje kreatin kinaze
English: Skin rash with pink-red blotches especially on palms of hands or soles of feet which may blister.
Slovenian: Kožni izpuščaj z rožnatordečimi mozolji zlasti na dlaneh ali na podplatih, kjer lahko nastanejo mehurji.
English: AMI = acute myocardial infarction; CABG = coronary artery bypass graft; CHD = coronary heart disease; MI = myocardial infarction; PTCA = percutaneous transluminal coronary angioplasty.
Slovenian: AMI = akutni miokardni infarkt; CABG (coronary artery bypass graft) = obvodna operacija koronarne arterije; MI = miokardni infarkt; PTCA (percutaneous transluminal coronary angioplasty) = perkutana transluminalna koronarna angioplastika
English: 1Based on difference in crude events rates occurring over a median follow-up of 3.9 years.
Slovenian: 1Na podlagi razlike med okvirnim številom dogodkov v povprečnem obdobju spremljanja 3,9 leta.
English: Rare reports of congenital anomalies following intrauterine exposure to HMG-CoA reductase inhibitors have been received.
Slovenian: Redko so poročali o prirojenih anomalijah po intrauterini izpostavljenosti zaviralcem HMG-CoA reduktaze.
English: − If you have any further questions, ask your doctor or pharmacist.
Slovenian: - Če imate dodatna vprašanja, se posvetujte z zdravnikom ali s farmacevtom.
English: If you experience any of the following serious side effects, stop taking your tablets and tell your doctor immediately or go to the nearest hospital accident and emergency department.
Slovenian: Če izkusite katerega izmed naslednjih resnih neželenih učinkov, prenehajte z jemanjem zdravila in nemudoma obvestite svojega zdravnika ali pojdite v najbližjo bolnišnico na nezgodni oddelek ali oddelek za nujno medicinsko pomoč.
English: − Serious allergic reaction which causes swelling of the face, tongue and throat that can cause great difficulty in breathing.
Slovenian: - Huda alergijska reakcija, ki povzroči oteklost obraza, jezika in sapnika, ki lahko povzroči velike težave pri dihanju.
English: Atorvastatin increased mean HDL-C by 2.9% (pravastatin: +5.6%, p=NS).
Slovenian: Atorvastatin je zvišal povprečni holesterol HDL za 2,9 % (pravastatin: +5,6 %, p = NZ).
English: Interaction studies evaluating the effects of amiodarone or verapamil on atorvastatin have not been conducted.
Slovenian: Študij o medsebojnem delovanju zdravil, ki bi ovrednotile učinke amiodarona ali verapamila na atorvastatin, ni.
English: The response is maintained during chronic therapy.
Slovenian: Odziv se med kroničnim zdravljenjem ohrani.
English: In cases where co-administration of these medicinal products with atorvastatin is necessary, the benefit and the risk of concurrent treatment should be carefully considered.
Slovenian: Če je potrebna sočasna uporaba teh zdravil z atorvastatinom, je treba natančno pretehtati koristi in tveganja takšnega sočasnega zdravljenja.
English: − If symptoms resolve and CK levels return to normal, then re-introduction of atorvastatin or introduction of an alternative statin may be considered at the lowest dose and with close monitoring.
Slovenian: - Če simptomi minejo in se CK normalizira, pretehtamo možnost ponovne uvedbe atorvastatina ali uvedbe kakšnega drugega statina v najmanjšem odmerku in ob natančnem nadzoru.
English: Maternal treatment with atorvastatin may reduce the fetal levels of mevalonate which is a precursor of cholesterol biosynthesis.
Slovenian: Zdravljenje nosečnic z atorvastatinom lahko plodu zmanjša raven mevalonata, ki je predhodnik biosinteze holesterola.
English: Clinical Recommendation
Slovenian: Klinično priporočilo
English: The safety profile of atorvastatin in the MIRACL study was consistent with what is described in section
Slovenian: Varnostni profil atorvastatina je bil v študiji MIRACL skladen z navedbami v poglavju 4.8.
English: Do not take {PRODUCT NAME} if you are pregnant, or if you are trying to become pregnant.
Slovenian: Ne jemljite zdravila {(Lastniško) ime}, če ste noseči ali če skušate zanositi.
English: After oral administration, atorvastatin film-coated tablets are 95% to 99% bioavailable compared to the oral solution.
Slovenian: Po peroralni uporabi filmsko obloženih tablet atorvastatina je njegova biološka uporabnost v primerjavi z raztopino od 95 do 99 %.
English: In rats, there is evidence of placental transfer.
Slovenian: Pri podganah obstajajo dokazi o prehodu skozi placento.
English: Poland, Romania, Slovakia, Slovenia
Slovenian: Romunija, Slovaška, Slovenija
English: − Muscle weakness, tenderness or pain and particularly, if at the same time, you feel unwell or have a high temperature it may be caused by an abnormal muscle breakdown which can be life-threatening and lead to kidney problems.
Slovenian: - Mišična šibkost, občutljivost na dotik ali bolečina, in še posebej, če to spremljata slabo počutje in vročina, lahko nastane zaradi nenormalne razgradnje mišic, ki je lahko življenjsko nevarno stanje in povzroča ledvične težave.
English: These differences were of no clinical significance, resulting in no clinically significant differences in lipid effects among men and women.
Slovenian: Razlike niso klinično pomembne in učinek zdravila na lipide se med moškimi in ženskami klinično ne razlikuje.
English: • an allergic reaction - symptoms may include sudden wheezing and chest pain or tightness, swelling of the eyelids, face, lips, mouth, tongue or throat, difficulty breathing, collapse
Slovenian: • alergijska reakcija - simptomi lahko vključujejo nenadno sopenje in bolečino ali prsno stisko, otekanje vek, obraza, ustnic, jezika in žrela, oteženo dihanje in kolaps
English: Do not take {PRODUCT NAME} if you are able to become pregnant unless you use reliable contraceptive measures.
Slovenian: Ne jemljite zdravila {(Lastniško) ime}, če obstaja možnost, da zanosite, razen če uporabljate učinkovito kontracepcijsko zaščito.