FrancophonIA/ELRC3.0 huggingface dataset:
English: In the 2-year rodent studies an increased number of liver tumors was observed in rats (in one rat study only) and in female mice and was interpreted as being due to pantoprazole's high metabolic rate in the liver.
Slovenian: V 2-letnih študijah pri glodavcih so pri podganah (samo v 1 študiji) in pri mišjih samicah opazili povečano število jetrnih tumorjev, kar naj bi bila posledica močno povečanega presnavljanja pantoprazola v jetrih.
English: - reduced absorption of Vitamin B12, and Vitamin B12 deficiency if you already have low body stores of Vitamin B12 - fracture of your hip, wrist or spine, especially if you already suffer from osteoporosis or if you are taking corticosteroids (which can increase the risk of osteoporosis).
Slovenian: Če zdravilo PANTOLOC Control prejemate daljše obdobje, lahko to povzroči dodatna tveganja, kot so: - zmanjšana absorpcija vitamina B12 in pomanjkanje vitamina B12, če že imate nizke telesne zaloge vitamina B12 - zlom kolka, zapestja ali hrbtenice, še posebej, če že trpite zaradi osteoporoze ali če jemljete kortikosteroide (ki lahko povečajo tveganje za osteoporozo).
English: However, according to the studies conducted so far, the formation of carcinoid precursors (atypical hyperplasia) or gastric carcinoids as were found in animal experiments (see section 5.3) have not been observed in humans.
Slovenian: V dosedanjih študijah pri ljudeh niso opazili tvorbe karcinoidnih predstopenj (atipična hiperplazija) ali želodčnih karcinoidov, kot so jih ugotovili pri poskusih na živalih (glejte poglavje 5.3).
English: Clearance is about 0.1 l/h/kg, and terminal half-life (t1/2) about 1 h. There were a few cases of subjects with delayed elimination.
Slovenian: Očistek je približno 0,1 l/h/kg, končni razpolovni čas (t1/2) pa približno 1 ura.
English: HIV Protease Inhibitors
Slovenian: Zaviralci proteaze HIV
English: The increased CgA level may interfere with investigations for neuroendocrine tumours.
Slovenian: Zvišana raven CgA lahko ovira preiskave glede nevroendokrinih tumorjev.
English: Severe hypomagnesaemia has been reported in patients treated with PPIs like pantoprazole for at least three months, and in most cases for a year.
Slovenian: O resni hipomagneziemiji so poročali pri bolnikih, ki so najmanj tri mesece, a v večini primerov eno leto, zdravljeni z zaviralci protonske črpalke, kot je pantoprazol.
English: PANTOLOC Control may reduce the absorption of active substances whose bioavailability is dependent on the gastric pH (e.g. ketoconazole).
Slovenian: Zdravilo PANTOLOC Control lahko zmanjša absorpcijo zdravilnih učinkovin, katerih biološka uporabnost je odvisna od pH želodčnega soka (npr. ketokonazol).
English: Therefore, in patients treated with coumarin anticoagulants (e.g. phenprocoumon or warfarin), monitoring of prothrombin time/INR is recommended after initiation, termination or during irregular use of pantoprazole.
Slovenian: Pri bolnikih, ki se zdravijo s kumarinskimi antikoagulansi (npr. fenprokumon ali varfarin), je po uvedbi ali zaključku zdravljenja s pantoprazolom ali v primeru njegove neredne uporabe priporočljivo spremljati vrednosti protrombinskega časa/INR.
English: Special populations No dose adjustment is necessary in elderly patients or in those with impaired renal or liver function.
Slovenian: Posebne skupine bolnikov Pri starejših bolnikih in bolnikih z okvaro delovanja ledvic ali jeter odmerka ni treba prilagajati.
English: Pantoprazole is a substituted benzimidazole which inhibits the secretion of hydrochloric acid in the stomach by specific blockade of the proton pumps of the parietal cells.
Slovenian: Pantoprazol je substituiran benzimidazol, ki zavira izločanje klorovodikove kisline v želodcu, s specifičnim zaviranjem protonske črpalke parietalnih celic.
English: Patients with long-term recurrent symptoms of indigestion or heartburn should see their doctor at regular intervals.
Slovenian: Bolniki z dolgotrajnimi, ponavljajočimi se simptomi dispepsije ali zgage, morajo redno obiskovati svojega zdravnika.
English: Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.
Slovenian: Druga zdravila in zdravilo PANTOLOC Control Obvestite zdravnika ali farmacevta, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo.
English: Therefore in settings where high-dose methotrexate is used, for example cancer and psoriasis, a temporary withdrawal of pantoprazole may need to be considered.
Slovenian: Pri uporabi visokih odmerkov metotreksata, npr. pri zdravljenju raka ali psoriaze, bo zdravljenje s pantoprazolom morda treba začasno prekiniti.
English: In addition, squamous cell papillomas were found in the forestomach of rats in one study.
Slovenian: Poleg tega so v eni študiji odkrili ploščatocelične papilome v predželodcu podgan.
English: • They have jaundice, hepatic impairment, or liver disease.
Slovenian: • če imajo zlatenico, okvaro jeter ali bolezen jeter.
English: Hypocalcemia in association with hypomagnesemia
Slovenian: Hipokalciemija v povezavi s hipomagneziemijo
English: How to store PANTOLOC Control Contents of the pack and other information
Slovenian: Shranjevanje zdravila PANTOLOC Control Vsebina pakiranja in dodatne informacije
English: Do not take PANTOLOC Control with other medicines which limit the amount of acid produced in your stomach, such as another proton pump inhibitor (omeprazole, lansoprazole or rabeprazole) or an H2 antagonist (e.g. ranitidine, famotidine).
Slovenian: Ne jemljite zdravila PANTOLOC Control z drugimi zdravili, ki zavirajo izločanje želodčne kisline, kot so drugi zaviralci protonske črpalke (omeprazol, lansoprazol ali rabeprazol) ali antagonisti histaminskih receptorjev H2 (npr. ranitidin, famotidin).
English: Typical symptoms are: swelling of the face, lips, mouth, tongue and/or throat, which may cause difficulty in swallowing or breathing, hives (nettle rash), severe dizziness with very fast heartbeat and heavy sweating.
Slovenian: Značilni znaki so: otekanje obraza, ustnic, ust, jezika in/ali žrela, kar lahko povzroči težave pri požiranju ali dihanju, urtikarija (koprivnica), huda omotica s pospešenim bitjem srca in močnim znojenjem.
English: Decreased gastric acidity, due to any means - including proton pump inhibitors - increases gastric counts of bacteria normally present in the gastrointestinal tract.
Slovenian: Zmanjšanje kislosti želodčnega soka iz kakršnega koli razloga, vključno z zaviralci protonske črpalke, poveča število želodčnih bakterij, ki so običajno prisotne v prebavilih.
English: Adverse reactions with pantoprazole in clinical trials and post-marketing experience
Slovenian: Neželeni učinki pantoprazola v kliničnih študijah in med spremljanjem zdravila po pridobitvi dovoljenja za promet
English: PANTOLOC Control should not be used during breast-feeding.
Slovenian: Zdravila PANTOLOC Control se med dojenjem ne sme uporabljati.
English: As pantoprazole is extensively protein bound, it is not readily dialysable.
Slovenian: Pantoprazol je pretežno vezan na proteine, zato se ga težko odstrani z dializo.
English: What PANTOLOC Control contains - The active substance is pantoprazole.
Slovenian: Kaj vsebuje zdravilo PANTOLOC Control - Zdravilna učinkovina je pantoprazol.
English: During treatment with antisecretory medicinal products, serum gastrin increases in response to the decreased acid secretion.
Slovenian: Med zdravljenjem z antisekretornimi zdravili se zaradi zmanjšanega izločanja kisline zviša gastrin v serumu.
English: - Coating: hypromellose, povidone, titanium dioxide (E171), yellow iron oxide (E172), propylene glycol, methacrylic acid-ethyl acrylate copolymer, sodium lauril sulfate, polysorbate 80, triethyl citrate.
Slovenian: - Obloga: hipromeloza, povidon, titanov dioksid (E171), rumeni železov oksid (E172), propilenglikol, kopolimer metakrilne kisline in etilakrilata, natrijev lavrilsulfat, polisorbat 80 in trietilcitrat.
English: 7 gastro-resistant tablets 14 gastro-resistant tablets
Slovenian: 7 gastrorezistentnih tablet 14 gastrorezistentnih tablet
English: The occurrence of these neoplasms is associated with the pantoprazole-induced changes in the breakdown of thyroxine in the rat liver.
Slovenian: Pojavnost teh novotvorb je povezana s spremenjeno razgradnjo tiroksina v jetrih podgan, ki jo povzroči pantoprazol.
English: Preclinical studies revealed no evidence of impaired fertility or teratogenic effects (see section 5.3).
Slovenian: Predklinične študije niso pokazale zmanjšane plodnosti ali teratogenih učinkov (glejte poglavje 5.3).
English: Pantoprazole, as all acid-blocking medicines, may reduce the absorption of vitamin B12 (cyanocobalamin) due to hypo- or achlorhydria.
Slovenian: Pantoprazol lahko kot vsa zdravila za znižanje kislosti zaradi hipo- ali aklorhidrije zmanjša absorpcijo vitamina B12 (cianokobalamina).
English: These might include: Chocolate, peppermint,
Slovenian: Med takšno hrano spadajo: čokolada,
English: Although no interaction during concomitant administration of phenprocoumon or warfarin has been observed in clinical pharmacokinetic studies, a few isolated cases of changes in International Normalised Ratio (INR) have been reported during concomitant treatment in the post-marketing period.
Slovenian: V kliničnih farmakokinetičnih študijah pri sočasni uporabi fenprokumona ali varfarina sicer niso opazili medsebojnega delovanja, vendar pa so med spremljanjem zdravila po pridobitvi dovoljenja za promet pri sočasni uporabi zabeležili nekaj posameznih primerov sprememb vrednosti internacionalnega normaliziranega razmerja (INR - International Normalised Ratio).
English: If no symptom relief is obtained within 2 weeks of continuous treatment, the patient should be instructed to consult a doctor.
Slovenian: Če se simptomi po 2 tednih neprekinjenega zdravljenja ne izboljšajo, se mora bolnik posvetovati s svojim zdravnikom.
English: You should not take this medicine if you are pregnant or while-breastfeeding.
Slovenian: Med nosečnostjo in dojenjem tega zdravila ne smete jemati.
English: Marketing Authorisation Holder Takeda GmbH
Slovenian: Imetnik dovoljenja za promet z zdravilom Takeda GmbH
English: As a result, a mild to moderate increase in the number of specific endocrine (ECL) cells in the stomach is observed in a minority of cases during long-term treatment (simple to adenomatoid hyperplasia).
Slovenian: Posledično pri dolgotrajnem zdravljenju v manjšem številu primerov pride do rahlega ali zmernega porasta števila specifičnih želodčnih endokrinih (ECL) celic (enostavna do adenomatozna hiperplazija).
English: OUTER CARTON FOR BLISTER OUTER CARTON FOR BLISTER WITH CARDBOARD REINFORCEMENT
Slovenian: ŠKATLA ZA PRETISNI OMOT ŠKATLA ZA PRETISNI OMOT S KARTONSKO OPORO
English: Posology The recommended dose is 20 mg pantoprazole (one tablet) per day.
Slovenian: Odmerjanje Priporočeni odmerek je 20 mg pantoprazola (ena tableta) na dan.
English: PANTOLOC Control is not recommended for use in children and adolescents below 18 years of age due to insufficient data on safety and efficacy.
Slovenian: Zaradi nezadostnih podatkov o varnosti in učinkovitosti uporaba zdravila PANTOLOC Control pri otrocih in mladostnikih, mlajših od 18 let, ni priporočljiva.
English: For the complete relief from acid regurgitation, similar results were obtained as for heartburn.
Slovenian: Glede popolnega izboljšanja simptomov regurgitacije kisline so bili rezultati podobni kot pri zgagi.
English: Take one tablet (20 mg) per day.
Slovenian: Vzemite eno tableto (20 mg) na dan. Ne prekoračite odmerka.
English: Tell your doctor immediately, before or after taking this medicine, if you notice any of the following symptoms, which could be a sign of another, more serious, disease: - an unintentional loss of weight (not related to a diet or an exercise programme) - vomiting, particularly if repeated - vomiting blood; this may appear as dark coffee grounds in your vomit - you notice blood in your stools; which may be black or tarry in appearance - difficulty in swallowing or pain when swallowing - you look pale and feel weak (anaemia) - chest pain - stomach pain - severe and/or persistent diarrhoea, because this medicine has been associated with a small increase in infectious diarrhoea.
Slovenian: Takoj obvestite svojega zdravnika, če pred ali po jemanju tega zdravila opazite katerega koli od spodaj navedenih simptomov, ki so lahko znaki druge, resnejše bolezni: - nenamerno izgubljanje telesne mase (ki ni posledica diete ali telesne vadbe), - bruhanje, še posebej ponavljajoče, - bruhanje krvi, ki se lahko kaže kot temna kavna usedlina v izbruhani vsebini, - kri v blatu, ki je črnega ali katranastega videza, - težko ali boleče požiranje, - bledica in oslabelost (slabokrvnost), - bolečina v prsih, - bolečina v želodcu, - huda in/ali trdovratna driska.
English: CARDBOARD REINFORCEMENT
Slovenian: KARTONSKA OPORA
English: - Very rare side effects (may affect up to 1 in 10,000 people): disorientation; reduction in the number of blood platelets, which may cause you to bleed or bruise more than normal; reduction in the number of white blood cells, which may lead to more frequent infections; coexisting abnormal reduction in the number of red and white blood cells, as well as platelets (seen in blood tests).
Slovenian: - Zelo redki neželeni učinki (pojavijo se lahko pri manj kot 1 od 10.000 bolnikov): dezorientiranost, zmanjšanje števila trombocitov, kar lahko povzroči pogostejše krvavitve ali pojav modric od običajnega, zmanjšanje števila belih krvnih celic, kar lahko privede do pogostejših okužb, sočasno neobičajno znižanje števila rdečih in belih krvnih celic kot tudi trombocitov (razvidno iz krvnih preiskav).
English: If you have been suffering from repetitive heartburn or indigestion symptoms for some time, remember to see your doctor regularly.
Slovenian: Če ponavljajoča se zgaga in dispeptične težave trajajo že nekaj časa, morate redno obiskovati svojega zdravnika.
English: The inhibition is dose-dependent and affects both basal and stimulated acid secretion.
Slovenian: Zaviranje je odvisno od odmerka in deluje tako na bazalno kot tudi stimulirano izločanje kisline.
English: Takeda GmbH Byk-Gulden-Str. 2 D-78467 Konstanz Germany
Slovenian: Takeda GmbH Byk-Gulden-Str. 2 D-78467 Konstanz Nemčija
English: SCLE after previous treatment with a proton pump inhibitor may increase the risk of SCLE with other proton pump inhibitors.
Slovenian: Subakutni kožni eritematozni lupus po predhodnem zdravljenju z zaviralcem protonske črpalke lahko poveča tveganje za pojav subakutnega kožnega eritematoznega lupusa z drugimi zaviralci protonske črpalke.
English: Ask your pharmacist how to throw away medicines you no longeruse.
Slovenian: O načinu odstranjevanja zdravila, ki ga ne uporabljate več, se posvetujte s farmacevtom.
English: In a peri-postnatal rat reproduction study designed to assess bone development, signs of offspring toxicity (mortality, lower mean body weight, lower mean body weight gain and reduced bone growth) were observed at exposures (Cmax) approximately 2x the human clinical exposure.
Slovenian: V peri-postnatalni reproduktivni študiji na podganah, katere namen je bila ocena razvoja kosti, so bili pri izpostavljenosti (Cmax), ki je približno 2-krat večja od klinične izpostavljenosti pri ljudeh, opaženi znaki toksičnosti za potomce (umrljivost, nižja povprečna telesna masa, nižji povprečni prirast telesne mase in slabša rast kosti).
English: - You should not take PANTOLOC Control tablets for more than 4 weeks without consulting a doctor.
Slovenian: - PANTOLOC Control tablet ne smete jemati dlje kot 4 tedne brez posveta z zdravnikom.
English: In most patients, freedom from heartburn and acid reflux symptoms is achieved in 1 week.
Slovenian: Simptomi zgage in kislega refluksa pri večini bolnikov izzvenijo v 1 tednu.
English: If you have no symptom-relief after taking this medicine for 2 weeks continuously, consult your doctor.
Slovenian: Če se znaki bolezni ne izboljšajo po 2 tednih neprekinjenega jemanja tega zdravila, se posvetujte z zdravnikom.
English: - Printing ink: shellac, red, black and yellow iron oxide (E172), and ammonia solution, concentrated.
Slovenian: - Tiskarsko črnilo: šelak, rdeči, črni in rumeni železov oksid (E 172) ter koncentrirana raztopina amoniaka.
English: Do not take this product for longer than 4 weeks without consulting your doctor.
Slovenian: Ne jemljite tega zdravila dlje kot 4 tedne brez posveta z zdravnikom.
English: The following recommendations for lifestyle and dietary changes may also help to relieve heartburn or acid related symptoms.
Slovenian: Naslednja priporočila za življenjski slog in prehranjevalne navade vam bodo morda tudi pomagala zmanjšati zgago in težave, povezane s kislino: - Izogibajte se velikim obrokom.
English: If you take more PANTOLOC Control than you should Tell your doctor or pharmacist if you have taken more than the recommended dose.
Slovenian: Če ste vzeli večji odmerek zdravila PANTOLOC Control, kot bi smeli Če ste vzeli večji odmerek zdravila PANTOLOC Control, kot bi smeli, o tem obvestite svojega zdravnika ali farmacevta.
English: - The other ingredients are: - Core: sodium carbonate (anhydrous), mannitol, crospovidone, povidone K90, calcium stearate.
Slovenian: - Pomožne snovi so: - Jedro: brezvodni natrijev karbonat, manitol, krospovidon, povidon K90 in kalcijev stearat.
English: Do not take a double dose to make up for the forgotten dose.
Slovenian: Če ste pozabili vzeti zdravilo PANTOLOC Control Ne vzemite dvojnega odmerka, če ste pozabili vzeti prejšnji odmerek.
English: There was no evidence of impaired fertility following the administration of pantoprazole in animal studies (see section 5.3).
Slovenian: Plodnost Pri študijah na živalih uporaba pantoprazola ni vplivala na plodnost (glejte poglavje 5.3).
English: How to take PANTOLOC Control
Slovenian: Kako jemati zdravilo PANTOLOC Control
English: On average, at about 2.0 h - 2.5 h post administration (tmax) of a single 20 mg oral dose, the maximum serum concentrations (Cmax) of about 1-1.5 µg/ml are achieved, and these values remain constant after multiple administration.
Slovenian: Največja koncentracija (Cmax) v serumu znaša približno od 1 do 1,5 µg/ml in je v povprečju dosežena od 2,0 do 2,5 ure (tmax) po enkratnem peroralnem odmerku 20 mg.
English: - if you are due to have a specific blood test (Chromogranin A) - if you are taking HIV protease inhibitors such as atazanavir, nelfinavir (for the treatment of
Slovenian: - ste naročeni na specifično preiskavo krvi (kromogranin A) - če jemljete zaviralce proteaze HIV, kot sta atazanavir; nelfinavir (za zdravljenje okužbe s HIV)
English: spearmint, fatty and fried food, acidic food, spicy food, citrus fruits and fruit juices, tomatoes.
Slovenian: poprova meta, zelena meta, mastne in ocvrte jedi, kisla hrana, začinjena hrana, agrumi, sadni sokovi in paradižnik.
English: - if you are taking HIV protease inhibitors such as atazanavir, nelfinavir (for the treatment of
Slovenian: - če jemljete zaviralce proteaze HIV, kot sta atazanavir, nelfinavir (za zdravljenje okužbe z virusom HIV).
English: Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist have told you.
Slovenian: Pri jemanju tega zdravila natančno upoštevajte napotke v tem navodilu ali navodila zdravnika ali farmacevta.
English: Gastrointestinal infections caused by bacteria
Slovenian: Bakterijske okužbe prebavil
English: Hypocalcaemia
Slovenian: Hipomagnezemija
English: No dose reduction is recommended when pantoprazole is administered to patients with impaired renal function (including patients on dialysis, which removes only negligible amounts of pantoprazole).
Slovenian: Pri bolnikih z okvaro delovanja ledvic (vključno z bolniki na dializi, ki odstrani le zanemarljivo količino pantoprazola), odmerka pantoprazola ni treba zmanjšati.
English: Penetration of the placenta was investigated in the rat and was found to increase with advanced gestation.
Slovenian: Prehajanje skozi placento so raziskovali pri podganah in ugotovili, da se povečuje s časom trajanja brejosti.
English: Pantoprazole is converted to its active form, a cyclic sulphenamide, in the acidic environment in the parietal cells where it inhibits the H+, K+-ATPase enzyme, i. e. the final stage in the production of hydrochloric acid in the stomach.
Slovenian: Pantoprazol se v svojo aktivno obliko, ciklični sulfenamid, pretvori v kislem okolju parietalnih celic, kjer zavira H
English: As with healthy subjects, the half-life of pantoprazole is short.
Slovenian: Razpolovni čas pantoprazola je kratek, tako kot pri zdravih osebah.
English: Co-administration of pantoprazole is contraindicated with HIV protease inhibitors for which absorption is dependent on acidic intragastric pH such as atazanavir, nelfinavir; due to significant reduction in their bioavailability (see section 4.3).
Slovenian: Sočasno zdravljenje skupaj z pantoprazolom z zaviralci proteaze HIV, pri katerih je absorpcija odvisna od pH želodčne kisline, kot so atazanavir, nelfinavir; zaradi znatnega zmanjšanja njihove biološke uporabnosti (glejte poglavje 4.5).
English: PANTOLOC Control 20 mg gastro-resistant tablets Pantoprazole
Slovenian: PANTOLOC Control 20 mg gastrorezistentne tablete pantoprazol
English: Red iron oxide (E172) Black iron oxide (E172) Yellow iron oxide (E172) Ammonia solution, concentrated
Slovenian: Tiskarsko črnilo šelak rdeči železov oksid (E172) črni železov oksid (E172) rumeni železov oksid (E172) koncentrirana raztopina amoniaka
English: The treatment should not exceed 4 weeks without consulting a doctor.
Slovenian: Zdravljenje brez posveta z zdravnikom ne sme trajati dlje kot 4 tedne.
English: Each tablet contains 20 mg pantoprazole (as sodium sesquihydrate).
Slovenian: Ena tableta vsebuje 20 mg pantoprazola (v obliki natrijevega seskvihidrata).
English: This is to allow CgA levels that might be spuriously elevated following PPI treatment to return to reference range.
Slovenian: Tako se raven CgA, ki se lahko zaradi zdravljenja z zaviralci protonske črpalke lažno poviša, vrne v referenčno območje.
English: Do not take PANTOLOC Control tablets for more than 4 weeks without consulting your doctor.
Slovenian: Ne jemljite tablet PANTOLOC Control več kot 4 tedne brez posveta pri zdravniku.
English: PANTOLOC Control 20 mg gastro-resistant tablets should not be chewed or crushed, and should be swallowed whole with liquid before a meal.
Slovenian: PANTOLOC Control 20 mg gastrorezistentnih tablet se ne sme žvečiti ali drobiti.
English: For short-term treatment of reflux symptoms (e.g. heartburn, acid regurgitation) in adults.
Slovenian: Za kratkotrajno zdravljenje simptomov refluksa (npr. zgaga, regurgitacija kisline) pri odraslih.
English: PANTOLOC Control is used for the short-term treatment of reflux symptoms (for example heartburn, acid regurgitation) in adults.
Slovenian: Zdravilo PANTOLOC Control uporabljamo za kratkotrajno zdravljenje simptomov refluksa (na primer zgaga, regurgitacija kisline) pri odraslih.
English: You may need further blood tests - methotrexate (used to treat rheumatoid arthritis, psoriasis, and cancer) - if you are taking methotrexate your doctor may temporarily stop your PANTOLOC Control treatment because pantoprazole can increase levels of methotrexate in the blood.
Slovenian: Če jemljete metotreksat, lahko zdravnik začasno prekine zdravljenje z zdravilom PANTOLOC Control, saj lahko pantoprazol zviša vrednosti metotreksata v krvi.
English: PANTOLOC Control 20 mg gastro-resistant tablets
Slovenian: PANTOLOC Control 20 mg gastrorezistentne tablete