FrancophonIA/ELRC3.0 huggingface dataset:
English: After administration of pantoprazole to patients with liver impairment (Child-Pugh classes A, B and C) the half-life values increased to between 3 and 7 h and the AUC values increased by a factor of 3-6, whereas the Cmax only increased slightly by a factor of 1.3 compared with healthy subjects.
Croatian: Nakon primjene pantoprazola u bolesnika s oštećenjem jetre (Child-Pugh stadiji A, B i C) vrijednosti poluvijeka se povećavaju na između 3 i 7 sati, a vrijednosti AUC se povećavaju za faktor 3-6, dok se Cmax povećava samo za faktor 1,3 u usporedbi sa zdravim ispitanicima.
English: In most patients, freedom from heartburn and acid reflux symptoms is achieved in 1 week.
Croatian: Kod većine bolesnika nestanak simptoma žgaravice i refluksa kiseline postiže se u 1 tjednu.
English: Alu/Alu blisters with or without cardboard reinforcement containing 7 or 14 gastro-resistant tablets.
Croatian: Al/Al blisteri sa ili bez kartonskog pojačanja koji sadrže 7 ili 14 želučanootpornih tableta.
English: The fasting gastrin values increase under pantoprazole.
Croatian: Vrijednosti gastrina natašte se pri primjeni pantoprazola povećavaju.
English: Penetration of the placenta was investigated in the rat and was found to increase with advanced gestation.
Croatian: Prodiranje kroz placentu je istraživano na štakorima i otkriveno je da se povećava s napredovanjem gestacije.
English: OTHER SPECIAL WARNING(S), IF NECESSARY
Croatian: DRUGO(A) POSEBNO(A) UPOZORENJE(A), (AKO JE POTREBNO)
English: Do not exceed this recommended dose of 20 mg pantoprazole daily.
Croatian: Nemojte prekoračiti preporučenu dozu od 20 mg pantoprazola dnevno.
English: Studies selected had to have at least one acid reflux symptom recording point at 2 weeks.
Croatian: Izabrana ispitivanja morala su imati barem jedan simptom refluksa kiseline nakon 2 tjedna.
English: Interaction studies with carbamazepine, caffeine, diazepam, diclofenac, digoxin, ethanol, glibenclamide, metoprolol, naproxen, nifedipine, phenytoin, piroxicam, theophylline and an oral contraceptive containing levonorgestrel and ethinyl oestradiol did not reveal clinically significant interactions.
Croatian: Ispitivanja interakcija s karbamazepinom, kofeinom, diazepamom, diklofenakom, digoksinom, etanolom, glibenklamidom, metoprololom, naproksenom, nifedipinom, fenitoinom, piroksikamom, teofilinom i oralnim kontraceptivom koji sadrži levonorgestrel i etinilestradiol nisu pokazala klinički značajne interakcije.
English: The increased mortality has only been reported in pre-weaning rat pups (up to 21 days age) which is estimated to correspond to infants up to the age of 2 years old.
Croatian: Povećana smrtnost prijavljena je samo u mladunaca štakora u razdoblju prije prestanka sisanja (u dobi do 21. dana), za koje je procijenjeno da odgovara životnom razdoblju djece u dobi od 2 godine.
English: Adverse reactions with pantoprazole in clinical trials and post-marketing experience
Croatian: Nuspojave pantoprazola u kliničkim ispitivanjima i iskustvu nakon stavljanja u promet
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).
Croatian: - smanjenje apsorpcije vitaminaB12 i pomanjkanje vitaminaB12 ako su vam tjelesne zalihe vitamina B12 već smanjene. - prijelom kuka, zapešćailikralježnice, posebno ako već bolujete od osteoporoze ili ako uzimate kortikosteroide (koji mogu povećati rizik od osteoporoze).
English: In these studies, the percentage of patients experiencing complete relief from heartburn after 7 days was between 54.0% and 80.6% in the pantoprazole group.
Croatian: U tim ispitivanjima, postotak bolesnika kod kojih je došlo do potpunog nestanka žgaravice nakon 7 dana bio je između 54,0% i 80,6% u skupini bolesnika na pantoprazolu.
English: After 14 and 28 days, complete heartburn relief was experienced in 62.9% to 88.6% and 68.1% to 92.3% of the patients, respectively.
Croatian: Nakon 14 i 28 dana, žgaravica je potpuno nestala kod 62,9% do 88,6%, odnosno 68,1% do 92,3% bolesnika.
English: Concomitant intake of food had no influence on bioavailability (AUC or Cmax), but increased the variability of the lag-time (tlag).
Croatian: Istodobni unos hrane nema utjecaja na bioraspoloživost (AUC ili Cmax), ali povećava varijabilnost vremena početka apsorpije (tlag).
English: CARDBOARD REINFORCEMENT
Croatian: KARTONSKO POJAČANJE
English: The effect is the same whether the active substance is given orally or intravenously.
Croatian: Učinak je jednak bez obzira daje li se djelatna tvar peroralno ili intravenski.
English: Pantoprazole is metabolized in the liver via the cytochrome P450 enzyme system.
Croatian: Pantoprazol se metabolizira u jetri preko citokrom P450 enzimskog sustava.
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.
Croatian: Prijavljena je teška hipomagnezijemija u bolesnika koji su liječeni inhibitorima protonske pumpe kao što je pantoprazol kroz najmanje tri mjeseca, a u većini slučajeva kroz godinu dana.
English: Also CgA increases due to decreased gastric acidity.
Croatian: CgA također raste zbog smanjene želučane kiselosti.
English: In these cases, malignancy should be excluded.
Croatian: U takvim je slučajevima potrebno isključiti maligne bolesti.
English: PANTOLOC Control should not be used by children and adolescents under 18 years of age due to a lack of safety information in this younger age group.
Croatian: PANTOLOC Control ne smiju koristiti djeca i mladi u dobi do 18 godina jer ne postoje podaci o sigurnosti primjene u ovoj mlađoj dobnoj skupini.
English: Observational studies suggest that proton pump inhibitors may increase the overall risk of fracture by 10-40%.
Croatian: Opservacijska ispitivanja ukazuju da inhibitori protonske pumpe mogu povećati ukupni rizik od prijeloma za 1040%.
English: Available published evidence suggests that proton pump inhibitors should be discontinued between 5 days and 2 weeks prior to CgA measurements.
Croatian: Dostupni podaci iz literature ukazuju na to da liječenje inhibitorima protonske pumpe treba prekinuti između 5 dana i 2 tjedna prije mjerenja CgA.
English: - You must talk to a doctor if you do not feel better or if you feel worse after 2 weeks.
Croatian: Pogledajte dio 4. - Obavezno se obratiteliječniku ako se ne osjećate bolje ili ako se osjećate lošije nakon 2 tjedna.
English: Investigations revealed no evidence of impaired fertility or teratogenic effects.
Croatian: U ispitivanjima nisu zabilježeni dokazi oštećenja plodnosti ili teratogeni učinci.
English: Especially, patients over 55 years taking any non-prescription indigestion or heartburn remedy on a daily basis should inform their pharmacist or doctor.
Croatian: Posebice bolesnici stariji od 55 godina koji svakodnevno uzimaju bilo kakve lijekove bez recepta protiv žgaravice ili indigestije moraju konzultirati ljekarnika ili liječnika.
English: Proton pump inhibitors, especially if used in high doses and over long durations (> 1 year), may modestly increase the risk of hip, wrist and spine fracture, predominantly in older people or in presence of other recognised risk factors.
Croatian: Inhibitori protonske pumpe, osobito ako se primjenjuju u visokim dozama i tijekom duljeg vremenskog perioda (> 1 godine), mogu umjereno povećati rizik od prijeloma kuka, zapešća i kralježnice, uglavnom u starijih osoba ili ako su prisutni drugi poznati čimbenici rizika.
English: • They are on continuous symptomatic treatment of indigestion or heartburn for 4 or more weeks.
Croatian: • trajno se simptomatski liječi od probavnih smetnji ili žgaravice tijekom 4 ili više tjedana.
English: Disturbances in vision / blurred vision
Croatian: Poremećaji oka smetnje vida / zamućen vid
English: For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Croatian: Za sve dodatne informacije o ovom lijeku obratite se lokalnom predstavniku nositelja odobrenja za stavljanje gotovog lijeka u promet.
English: This may cause you symptoms such as a painful burning sensation in the chest rising up to the throat (heartburn) and a sour taste in the mouth (acid regurgitation).
Croatian: To može uzrokovati simptome kao što su bolan osjećaj pečenja u prsnom košu koji se uzdiže do grla (žgaravica) i kiseli okus u ustima (vraćanje kiseline iz želuca u usta).
English: Pantoprazole/metabolites have been identified in human milk.
Croatian: Pantoprazol i metaboliti pronađeni su u majčinom mlijeku u ljudi.
English: This leaflet was last revised in { mm/yyyy}
Croatian: Ova uputa je zadnji puta revidirana u MM/GGGG
English: Due to the specific binding of pantoprazole to the proton pumps within the parietal cell, the elimination half-life does not correlate with the much longer duration of action (inhibition of acid secretion).
Croatian: Zbog specifičnog vezanja pantoprazola na protonske pumpe unutar parijetalnih stanica, poluvijek eliminacije ne korelira s mnogo dužim trajanjem djelovanja (inhibicije lučenja kiseline).
English: If your reflux symptoms (heartburn or acid regurgitation) persist for longer than 2 weeks, consult your doctor who will decide about the need for long-term intake of this medicinal product.
Croatian: Ako simptomi refluksa (žgaravica ili vraćanje kiseline iz želuca u usta) potraju dulje od 2 tjedna posavjetujte se s liječnikom, koji će odlučiti o potrebi za dugotrajnim uzimanjem ovog lijeka.
English: If CgA and gastrin levels have not returned to reference range after initial measurement, measurements should be repeated 14 days after cessation of proton pump inhibitor treatment.
Croatian: Ako se razine CgA i gastrina ne vrate unutar referentnih vrijednosti nakon početnog mjerenja, mjerenje treba ponoviti 14 dana nakon prekida liječenja inhibitorom protonske pumpe.
English: Reflux is the backflow of acid from the stomach into the gullet (“foodpipe”), which may become inflamed and painful.
Croatian: Refluks je povrat kiseline iz želuca u jednjak („cijev za hranu”) koji može postati upaljen i bolan.
English: Pantoprazole should not be used during pregnancy.
Croatian: Pantoprazol se ne smije uzimati tijekom trudnoće.
English: In the dose range of 10 to 80 mg, the plasma kinetics of pantoprazole are linear after both oral and intravenous administration.
Croatian: U rasponu doza od 10 do 80 mg, kinetike pantoprazola u plazmi su linearne nakon peroralne i nakon intravenske primjene.
English: Very rare
Croatian: Manje česte Rijetke
English: If affected, patients should not drive or use machines.
Croatian: U takvim slučajevima bolesnici ne smiju upravljati vozilima ili raditi sa strojevima.
English: PANTOLOC Control contains the active substance pantoprazole, which blocks the ‘pump' that produces stomach acid.
Croatian: PANTOLOC Control sadrži djelatnu tvar pantoprazol, koja blokira „pumpu“ koja proizvodi želučanu kiselinu.
English: You should take this medicine for at least 2-3 consecutive days.
Croatian: Lijek treba uzimati najmanje 2-3 dana za redom.
English: Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Croatian: Unutar svake grupe učestalosti, nuspojave su poredane u padajućem nizu prema stupnju ozbiljnosti.
English: Patients at risk of osteoporosis should receive care according to current clinical guidelines and they should have an adequate intake of vitamin D and calcium.
Croatian: Bolesnici koji su pod rizikom od nastanka osteoporoze moraju primati skrb u skladu s važećim kliničkim smjernicama te imati primjeren unos vitamina D i kalcija.
English: Patients should not take pantoprazole as a preventive medicinal product.
Croatian: Bolesnici ne smiju uzimati pantoprazol profilaktički.
English: The mechanism leading to the formation of gastric carcinoids by substituted benzimidazoles has been carefully investigated and allows the conclusion that it is a secondary reaction to the massively elevated serum gastrin levels occurring in the rat during chronic high-dose treatment.
Croatian: Mehanizam kojim supstituirani benzimidazoli dovode do formiranja gastričkih karcinoida je pomno proučen i zaključeno je da se radi o sekundarnoj reakciji na veliko povećanje serumske razina gastrina koje se javlja u štakora tijekom kroničnog liječenja visokim dozama.
English: Treatment with acid-reducing medicinal products leads to a slightly increased risk of gastrointestinal infections such as Salmonella, Campylobacter, or Clostridium difficile.
Croatian: Liječenje lijekovima koji smanjuju kiselost vodi do blagog povećanja rizika od gastrointestinalnih infekcija s npr. Salmonella, Campylobacter, ili Clostridium difficile.
English: See ‘Other medicines and PANTOLOC Control'.
Croatian: Pogledajte 'Ostali lijekovi i PANTOLOC Control'.
English: What you need to know before you take PANTOLOC Control
Croatian: Što morate znati prije nego počnete uzimati PANTOLOC Control
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.
Croatian: Tijekom 2-godišnjih ispitivanja na glodavcima opažen je povećan broj tumora jetre kod štakora (u samo jednom ispitivanju na štakorima) i ženki miševa, što je protumačeno kao posljedica visoke stope metabolizma pantoprazola u jetri.
English: What PANTOLOC Control contains - The active substance is pantoprazole.
Croatian: Što PANTOLOC Control sadrži - Djelatna tvar je pantoprazol.
English: By the end of the recovery phase, bone parameters were similar across groups and body weights were also trending toward reversibility after a drug-free recovery period.
Croatian: Do kraja faze oporavka, koštani parametri bili su slični u svim ispitivanim skupinama, a tjelesna je težina tijekom razdoblja oporavka bez primjene lijeka pokazivala trend ka reverzibilnosti.
English: - falling magnesium levels in your blood (potential symptoms: fatigue, involuntary muscle contractions, disorientation, convulsions, dizziness, increased heart rate).
Croatian: - smanjenje razine magnezija u krvi(potencijalni simptomi: umor, nevoljno stezanje mišića, dezorijentacija, konvulzije, omaglica, povećan broj otkucaja srca).
English: In a retrospective analysis of 17 studies in 5960 patients with gastro-oesophageal reflux disease (GORD) who were treated with 20 mg pantoprazole monotherapy, the symptoms associated with acid reflux e.g. heartburn and acid regurgitation were evaluated according to a standardised methodology.
Croatian: Retrospektivnom analizom 17 ispitivanja na 5960 bolesnika s gastroezofagealnom refluksnom bolesti (GERB) koji su liječeni monoterapijom s 20 mg pantoprazola, prema standardiziranoj metodologiji su procijenjivani simptomi povezani s refluksom kiseline, npr. žgaravica i regurgitacija kiseline.
English: The inhibition is dose-dependent and affects both basal and stimulated acid secretion.
Croatian: Inhibicija je ovisna o dozi i utječe na bazalnu i stimuliranu sekreciju kiseline.
English: The occurrence of these neoplasms is associated with the pantoprazole-induced changes in the breakdown of thyroxine in the rat liver.
Croatian: Pojava takvih neoplazmi povezana je s pantoprazolom izazvanih promjena u razgradnji tiroksina u jetri štakora.
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.
Croatian: Pantoprazol prelazi u svoj aktivni oblik, ciklički sulfenamid, u kiselim uvjetima u parijetalnim stanicama gdje inhibira enzim H+, K+-ATP-azu, tj. završnu fazu proizvodnje kloridne kiseline u želucu.
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.
Croatian: U peri- postnatalnom reproduktivnom ispitivanju u štakora, dizajniranom za ocjenu razvoja kostiju, znakovi toksičnosti u potomstva (smrtnost, snižena srednja vrijednost tjelesne težine, snižena srednja vrijednost prirasta tjelesne težine i smanjen rast kostiju) zabilježeni su pri izloženostima (Cmax) približno 2x većima od kliničke izloženosti u ljudi.
English: Concomitant use of high dose methotrexate (e.g. 300 mg) and proton-pump inhibitors has been reported to increase methotrexate levels in some patients.
Croatian: Kod istodobne primjene visokih doza metotreksata (npr. 300 mg) i inhibitora protonske pumpe prijavljen je porast razine metotreksata kod nekih bolesnika.
English: mm/yyyy
Croatian: {MM/GGGG}
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).
Croatian: Ne uzimajte PANTOLOC Control s drugim lijekovima koji ograničavaju količinu proizvodnje želučane kiseline, kao što su drugi inhibitor protonske pumpe (omeprazol, lanzoprazol ili rabeprazol) ili H2 antagonist (npr. ranitidin, famotidin).
English: As the therapeutic dose in man is low, no side effects on the thyroid glands are expected.
Croatian: S obzirom da je terapijska doza kod ljudi niska, ne očekuju se nuspojave lijeka na štitnjaču.
English: Other side effects include: - Common (may affect up to 1 in 10 people): Benign polyps in the stomach
Croatian: Ostale nuspojave uključuju: - Česte nuspojave (mogu se javiti u do 1 na 10 osoba): dobroćudni polipi u želucu.
English: If lesions occur, especially in sun-exposed areas of the skin, and if accompanied by arthralgia, the patient should seek medical help promptly and the health care professional should consider stopping PANTOLOC Control.
Croatian: Ako nastupe lezije, posebice na suncem izloženim područjima kože, te ako su popraćene artralgijom, bolesnik treba odmah potražiti medicinsku pomoć, a zdravstveni radnik treba razmotriti prekid liječenja lijekom PANTOLOC Control.
English: Since pantoprazole binds to the enzyme distal to the receptor level, it can inhibit hydrochloric acid secretion independently of stimulation by other substances (acetylcholine, histamine, gastrin).
Croatian: Budući da se pantoprazol veže na enzime distalne razini staničnih receptora, može inhibirati lučenje kloridne kiseline neovisno o stimulaciji drugim tvarima (acetilkolinom, histaminom, gastrinom).
English: Production site Oranienburg Lehnitzstraße 70-98, 16515 Oranienburg
Croatian: Lehnitzstrasse 70-98, 16515 Oranienburg
English: Packs containing 7 or 14 gastro-resistant tablets.
Croatian: Pakiranje sadrži 7 ili 14 želučanootpornih tableta.
English: It may be necessary to take the tablets for 2-3 consecutive days to relieve the symptoms.
Croatian: Možda će biti potrebno uzimati tablete 2-3 uzastopna dana da bi se postiglo olakšanje simptoma.
English: Yellow, oval biconvex film-coated tablets imprinted with “P20” in brown ink on one side.
Croatian: Žute, ovalne, bikonveksne, filmom obložene tablete sa smeđom oznakom "P20" na jednoj strani.
English: As pantoprazole is extensively protein bound, it is not readily dialysable.
Croatian: Kako se pantoprazol u velikoj mjeri veže na proteine, ne dijalizira se lako.
English: There was no evidence of impaired fertility following the administration of pantoprazole in animal studies (see section 5.3).
Croatian: Nije bilo dokaza smanjenja plodnosti nakon primjene pantoprazola u ispitivanjima na životinjama (vidjeti dio 5.3).
English: Renal elimination represents the major route of excretion (about 80%) for the metabolites of pantoprazole; the rest is excreted with the faeces.
Croatian: Metaboliti pantoprazola najvećim se dijelom eliminiraju izlučivanjem putem bubrega (oko 80%), a ostatak se izlučuje stolicom.
English: • They have jaundice, hepatic impairment, or liver disease.
Croatian: • ima žuticu, oštećenje jetre ili bolest jetre.
English: • They have unintentional weight loss, anaemia, gastrointestinal bleeding, dysphagia, persistent vomiting or vomiting with blood, since it may alleviate symptoms and delay diagnosis of a severe condition.
Croatian: • nenamjerno gubi na težini, ima anemiju, gastrointestinalno krvarenje, disfagiju, stalno povraća ili povraća krv, jer u tom slučaju može ublažiti simptome i odgoditi dijagnozu teške bolesti.
English: • They have had previous gastric ulcer or gastrointestinal surgery.
Croatian: • ima gastrički ulkus ili operaciju gastrointestinalnog trakta u anamnezi.
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.
Croatian: Stoga u okolnostima kad se primjenjuju visoke doze metotreksata, na primjer kod karcinoma ili psorijaze, treba razmisliti o privremenom prestanku primjene pantoprazola.
English: If you forget to take PANTOLOC Control
Croatian: Ako ste zaboravili uzeti PANTOLOC Control
English: However, you may take PANTOLOC Control with antacids (e.g. magaldrate, alginic acid, sodium bicarbonate, aluminium hydroxide, magnesium carbonate, or combinations thereof), if needed.
Croatian: Ako je potrebno, PANTOLOC Control možete uzimati s antacidima (npr. megaldrat, alginatna kiselina, natrijev bikarbonat, aluminijev hidroksid, magnezijev karbonat ili kombinacije navedenih).
English: Pantoprazole reduces acidity in the stomach and thereby increases gastrin in proportion to the reduction in acidity.
Croatian: Pantoprazol smanjuje kiselost u želucu, a proporcionalno smanjenju kiselosti povećava se razina gastrina.
English: After 7 days the percentage of patients experiencing complete relief from acid regurgitation was between 61.5% and 84.4%, after 14 days between 67.7% and 90.4%, and after 28 days between 75.2% and 94.5%, respectively.
Croatian: Kod 61,5% do 84,4% bolesnika regurgitacija kiseline je potpuno nestala nakon 7 dana, kod 67,7% do 90,4% nakon 14 dana, a kod 75,2% do 94,5% nakon 28 dana.
English: - The other ingredients are: - Core: sodium carbonate (anhydrous), mannitol, crospovidone, povidone K90, calcium stearate.
Croatian: - Drugi sastojci su: - Jezgra: natrijev karbonat (bezvodni), manitol, krospovidon, povidon K90, kalcijev stearat.
English: Serious manifestations of hypomagnesaemia such as fatigue, tetany, delirium, convulsions, dizziness, and ventricular arrhythmia can occur but they may begin insidiously and be overlooked.
Croatian: Mogu se pojaviti ozbiljne manifestacije hipomagnezijemije kao što su umor, tetanija, delirij, konvulzije, omaglica i ventrikularna aritmija, čiji nastup može biti podmukao i može ga se previdjeti.
English: This should be considered in patients with reduced body stores or risk factors for reduced vitamin B12 absorption on long-term therapy or if respective clinical symptoms are observed.
Croatian: To se mora uzeti u obzir kod bolesnika sa smanjenim zalihama ili čimbenicima rizika za smanjenju apsorpciju vitamina B12 na dugotrajnoj terapiji ili ako se pojave klinički simptomi nedostatka vitamina B12.
English: PANTOLOC Control should not be used during breast-feeding.
Croatian: Pantoloc Control ne smije se koristiti tijekom dojenja.
English: The following adverse reactions have been reported with pantoprazole.
Croatian: Prijavljene su sljedeće nuspojave pantoprazola.
English: As a result, concentration of pantoprazole in the foetus is increased shortly before birth.
Croatian: Zbog toga je neposredno prije rođenja kod fetusa povećana koncentracija pantoprazola.