FrancophonIA/ELRC3.0 huggingface dataset:
English: During transient illnesses such as low grade infection, fever of any aetiology, stressful situations such as minor surgical procedures, the daily replacement dose must be increased temporarily, see section 4.2, ‘Use in intercurrent illness'.
Slovenian: naporne situacije, kot so manjši kirurški posegi, je treba dnevni nadomestni odmerek začasno povečati; glejte poglavje 4.2 „Uporaba pri sočasni bolezni“.
English: Do not divide, crush or chew tablets.
Slovenian: Tablet ne smete prelomiti, zdrobiti ali prežvečiti.
English: Special populations
Slovenian: Posebne populacije Starejši bolniki
English: These medicines have also been given for other indications than adrenal insufficiency replacement therapy, often in higher doses.
Slovenian: Ta zdravila se, pogosto z večjimi odmerki, uporabljajo tudi pri drugih indikacijah, ne samo pri nadomestnem zdravljenju adrenalne insuficience.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/11/715/002 50 modified-release tablets EU/1/11/715/006 100 (2x50) modified-release tablets
Slovenian: EU/1/11/715/002 50 tablet s prirejenim sproščanjem EU/1/11/715/006 100 (2x50) tablet s prirejenim sproščanjem
English: Plenadren 20 mg: the tablets are white.
Slovenian: 20 mg tablete so bele barve.
English: Carton containing 2 bottles of 50 modified-release tablets (100 tablets).
Slovenian: Kartonska škatla, ki vsebuje 2 plastenki s po 50 tabletami s prirejenim sproščanjem (100 tablet).
English: Patients should be instructed to take Plenadren orally with a glass of water on awakening at least 30 minutes before food intake, preferably in an upright position and between 6.00 am and 8.00 am in the morning.
Slovenian: vsaj 30 minut pred zaužitjem hrane, po možnosti v pokončnem položaju, in sicer med 6. in 8. uro zjutraj.
English: Cortisol is the principal glucocorticoid secreted by the adrenal cortex.
Slovenian: Kortizol je glavni glukokortikoid, ki ga izloča skorja nadledvične žleze.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS BOTTLE
Slovenian: PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH
English: Plenadren 5 mg modified-release tablets The tablets are round (diameter 8 mm), convex and pink.
Slovenian: Plenadren 5 mg tablete s prirejenim sproščanjem Tablete so okrogle (s premerom 8 mm), izbočene in rožnate.
English: Frequency of adverse reactions Very common Common
Slovenian: Pogostnost neželenih učinkov
English: • Itchiness
Slovenian: • omotica
English: You can breast-feed during Plenadren treatment.
Slovenian: Med zdravljenjem z zdravilom Plenadren lahko dojite.
English: What you need to know before you take Plenadren
Slovenian: Kaj je zdravilo Plenadren in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Plenadren Kako jemati zdravilo Plenadren
English: Upper abdominal pain Nausea
Slovenian: Bolezni prebavil driska bolečine v zgornjem predelu trebuha navzea
English: Plenadren 5 mg: Each modified-release tablet contains 5 mg of hydrocortisone.
Slovenian: Plenadren 5 mg: ena tableta s prirejenim sproščanjem vsebuje 5 mg hidrokortizona.
English: • The active substance is hydrocortisone.
Slovenian: Učinkovina je hidrokortizon.
English: Events have been reported in patients treated with Plenadren.
Slovenian: O primerih akutne adrenalne insuficience so poročali pri bolnikih, ki so prejemali zdravilo Plenadren.
English: Plenadren 20 mg: Each modified-release tablet contains 20 mg of hydrocortisone.
Slovenian: Plenadren 20 mg: ena tableta s prirejenim sproščanjem vsebuje 20 mg hidrokortizona.
English: A total of 80 patients (173 patient-years of data) have been treated with modified-release hydrocortisone in clinical studies.
Slovenian: Tabelarični pregled neželenih učinkov V kliničnih študijah so s hidrokortizonom s prirejenim sproščanjem zdravili skupno 80 bolnikov (173
English: If extra doses are needed frequently and regularly, you should contact your doctor for re-evaluation of your maintenance dose.
Slovenian: Če potrebujete dodatne odmerke pogosto in redno,
English: Additional side effects have been reported for other hydrocortisone medicines.
Slovenian: Pri drugih zdravilih, ki vsebujejo hidrokortizon, so poročali tudi o drugih neželenih učinkih.
English: This may require dose individualisation.
Slovenian: Zaradi tega bo morda potrebna prilagoditev odmerka.
English: Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu.
Slovenian: Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila http://www.ema.europa.eu/, kjer so na voljo tudi povezave do drugih spletnih strani o redkih boleznih in zdravljenju.
English: Psychiatric adverse reactions may occur with systemic glucocorticoids.
Slovenian: Pri uporabi sistemskih glukokortikoidov se lahko pojavijo psihiatrični neželeni učinki.
English: Animal studies have also shown that prenatal exposure to high doses of glucocorticoids (but lower than teratogenic doses) may be associated with increased risk of intrauterine growth retardation, cardiovascular disease in adulthood and permanent changes in glucocorticoid receptor density, neurotransmitter turnover and behaviour.
Slovenian: Poskusi na živalih so prav tako pokazali, da je predporodna izpostavitev visokim odmerkom glukokortikoidov (ki pa so manjši kot teratogeni) lahko povezana s povečanim tveganjem za znotrajmaternični zastoj rasti,
English: Potent CYP 3A4 inhibitors such as ketoconazole, itraconazole, posaconazole, voriconazole erythromycin, telithromycin, clarithromycin, ritonavir and grapefruit juice can inhibit the metabolism of hydrocortisone, and thus increase blood levels.
Slovenian: Močni zaviralci CYP 3A4, kot so ketokonazol, itrakonazol, posakonazol, vorikonazol, eritromicin,
English: Carton containing 1 bottle of 50 modified-release tablets.
Slovenian: Kartonska škatla, ki vsebuje 1 plastenko s po 50 tabletami s prirejenim sproščanjem.
English: • Tiredness
Slovenian: • driska
English: Acute adrenal insufficiency
Slovenian: 4.4 Posebna opozorila in previdnostni ukrepi Akutna adrenalna insuficienca
English: MARKETING AUTHORISATION NUMBER(S) EU/1/11/715/001 50 modified-release tablets EU/1/11/715/003 100 (2x50) modified-release tablets
Slovenian: EU/1/11/715/003 100 (2x50) tablet s prirejenim sproščanjem
English: Due to a lower bioavailability of the daily dose of Plenadren compared to that of conventional hydrocortisone tablets given three times daily (see section 5.2) clinical response needs to be monitored and further dose individualisation may be required.
Slovenian: Zaradi nižje biološke razpoložljivosti dnevnega odmerka zdravila Plenadren v primerjavi s konvencionalnimi tabletami hidrokortizona, ki se jemljejo trikrat na dan (glejte poglavje
English: Gastrointestinal disorders Dyspepsia and deterioration of existing gastric ulcer.
Slovenian: Dispepsija in poslabšanje obstoječih razjed želodca.
English: Plenadren 5 mg modified-release tablets Plenadren 20 mg modified-release tablets Hydrocortisone
Slovenian: Plenadren 5 mg tablete s prirejenim sproščanjem Plenadren 20 mg tablete s prirejenim sproščanjem hidrokortizon
English: In addition, tell your doctor or pharmacist if you are using any of the following medicines, as the dose of Plenadren may need to be changed:
Slovenian: Poleg tega zdravnika ali farmacevta obvestite, če uporabljate katero od spodaj navedenih zdravil, saj bo morda treba spremeniti vaš odmerek zdravila Plenadren:fenitoin, karbamazepin in barbiturate uporabljajo se za zdravljenje epilepsije
English: Plenadren 20 mg modified-release tablets The tablets are round (diameter 8 mm), convex and white.
Slovenian: Tablete so okrogle (s premerom 8 mm), izbočene in bele.
English: Hepatic impairment
Slovenian: Bolezni živčevja vrtoglavica glavobol
English: Plenadren 20 mg modified-release tablets Each modified-release tablet contains hydrocortisone 20 mg.
Slovenian: Plenadren 20 mg tablete s prirejenim sproščanjem Ena tableta s prirejenim sproščanjem vsebuje 20 mg hidrokortizona.
English: Titanium dioxide (E171)
Slovenian: Obloga tablete makrogol (3350) polivinilalkohol smukec titanov dioksid (E171)
English: • The other ingredients are hypromellose, microcrystalline cellulose, pregelatinised starch (maize), colloidal anhydrous silica and magnesium stearate.
Slovenian: Pomožne snovi so hipromeloza (E464), mikrokristalinska celuloza (E460), predgelirani škrob (koruzni), brezvodni koloidni silicijev dioksid (E551) in magnezijev stearat.
English: This medicine may have minor influence on your ability to drive and use machines.
Slovenian: Vpliv na sposobnost upravljanja vozil in strojev To zdravilo ima lahko blag vpliv na sposobnost upravljanja vozil in strojev.
English: There is no need for dosage adjustment in patients with mild to moderate renal impairment.
Slovenian: Pri bolnikih z blago do zmerno okvarjenim delovanjem jeter ni treba prilagajati odmerka.
English: Thyroid function
Slovenian: Okvarjeno delovanje jeter
English: Plenadren 20 mg modified-release tablets Tablet coating
Slovenian: Plenadren 20 mg tablete s prirejenim sproščanjem
English: How to store Plenadren
Slovenian: Shranjevanje zdravila Plenadren
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 3
Slovenian: DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Z ZDRAVILOM
English: Polyvinyl alcohol
Slovenian: OVOJNINAH PLASTENKA
English: Gastric emptying and motility disorders
Slovenian: Praznjenje želodca in motnje gibljivosti črevesja
English: NAME OF THE MEDICINAL PRODUCT Plenadren 20 mg modified-release tablets hydrocortisone
Slovenian: Plenadren 20 mg tablete s prirejenim sproščanjem hidrokortizon peroralna uporaba
English: Plenadren 5 mg modified-release tablets Tablet coating
Slovenian: Plenadren 5 mg tablete s prirejenim sproščanjem
English: Use in intercurrent illness
Slovenian: Bolezni prebavil
English: HDPE bottles with PP screw cap containing 50 modified-release tablets.
Slovenian: Plastenke iz polietilena visoke gostote s polipropilensko navojno zaporko, ki vsebujejo po 50 tablet s prirejenim sproščanjem.
English: Contact your doctor promptly for advice if you notice any of these.
Slovenian: Če opazite kaj od tega, se nemudoma posvetujte z zdravnikom.
English: NAME OF THE MEDICINAL PRODUCT Plenadren 5 mg modified-release tablets hydrocortisone
Slovenian: Plenadren 5 mg tablete s prirejenim sproščanjem hidrokortizon peroralna uporaba
English: Tabulated list of adverse reactions
Slovenian: Posebne populacije Okvarjeno delovanje ledvic
English: NAME OF THE MEDICINAL PRODUCT Plenadren 5 mg modified-release tablets Plenadren 20 mg modified-release tablets
Slovenian: Plenadren 5 mg tablete s prirejenim sproščanjem Plenadren 20 mg tablete s prirejenim sproščanjem
English: PHARMACEUTICAL FORM AND CONTENTS Modified-release tablet
Slovenian: FARMACEVTSKA OBLIKA IN VSEBINA
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each modified-release tablet contains hydrocortisone 20 mg.
Slovenian: NAVEDBA ENE ALI VEČ UČINKOVIN Ena tableta s prirejenim sproščanjem vsebuje 20 mg hidrokortizona.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each modified-release tablet contains hydrocortisone 5 mg.
Slovenian: NAVEDBA ENE ALI VEČ UČINKOVIN Ena tableta s prirejenim sproščanjem vsebuje 5 mg hidrokortizona.
English: Ask your doctor promptly for information on how you should handle these situations.
Slovenian: Glede ravnanja v takšnih primerih se nemudoma posvetujte z zdravnikom.
English: Tablet core
Slovenian: Tablete pogoltnite cele.
English: Package leaflet: Information for the patient
Slovenian: Vsebina pakiranja in dodatne informacije Kaj vsebuje zdravilo Plenadren
English: You should tell your doctor if you become pregnant as the dose of Plenadren may have to be adjusted.
Slovenian: Če med jemanjem zdravila Plenadren zanosite, o tem obvestite zdravnika, saj bo morda moral prilagoditi odmerek.
English: Date of first authorisation: 24 August 2005 Date of latest renewal: 24 April 2015
Slovenian: Datum prve odobritve: 24. avgust 2005 Datum zadnjega podaljšanja: 24. april 2015
English: No special requirements.
Slovenian: Ni posebnih zahtev za.
English: Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Slovenian: Obvestite zdravnika ali farmacevta, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli zdravilo.
English: It contains important information reminding you how to take FOSAVANCE properly.
Slovenian: Ta vsebuje pomembne informacije, ki vas spomnijo, kako pravilno jemati zdravilo FOSAVANCE.
English: Due to the nature of the disease process in osteoporosis, FOSAVANCE is intended for long-term use.
Slovenian: Zaradi narave bolezenskega procesa osteoporoze je zdravilo FOSAVANCE namenjeno za dolgotrajno uporabo.
English: Children and adolescents FOSAVANCE should not be given to children and adolescents less than 18 years of age.
Slovenian: Otroci in mladostniki Zdravila FOSAVANCE se ne sme dajati otrokom in mladostnikom, mlajšim od 18 let.
English: 5,600 IU
Slovenian: 5600 i.e.
English: Do not use this medicine after the expiry date which is stated on the carton and the blister after EXP.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in pretisnem omotu poleg oznake EXP.
English: Therefore, caution should be used when these medicines are taken at the same time as FOSAVANCE.
Slovenian: Zato je potrebna previdnost, kadar ta zdravila uporabljate istočasno kot zdravilo FOSAVANCE.
English: FOSAVANCE has no or negligible direct influence on the ability to drive and use machines.
Slovenian: Zdravilo FOSAVANCE nima neposrednega vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja strojev.
English: • rash made worse by sunlight;
Slovenian: • izpuščaj, ki se poslabša na soncu
English: 2,800 IU
Slovenian: 2800 i.e.
English: Since it is not known how long you should take FOSAVANCE, you should discuss the need to stay on this medicine with your doctor periodically to determine if FOSAVANCE is still right for you.
Slovenian: Ker ni znano, kako dolgo je treba jemati zdravilo FOSAVANCE, se morate glede nadaljevanja zdravljenja s tem zdravilom redno posvetovati z zdravnikom, ki bo odločil, ali je zdravljenje z zdravilom FOSAVANCE za vas še vedno primerno.
English: If you take more FOSAVANCE than you should If you take too many tablets by mistake, drink a full glass of milk and contact your doctor immediately.
Slovenian: Če ste vzeli večji odmerek zdravila FOSAVANCE, kot bi smeli Če po pomoti vzamete preveč tablet, popijte poln kozarec mleka in nemudoma pokličite zdravnika.
English: The need for continued treatment should be re-evaluated periodically based on the benefits and potential risks of FOSAVANCE on an individual patient basis, particularly after 5 or more years of use.
Slovenian: Potrebo po nadaljevanju zdravljenja z zdravilom FOSAVANCE je treba ponovno periodično oceniti glede na koristi in tveganja za posameznega bolnika, še posebno po 5 letih ali več uporabe.
English: The safety and efficacy of FOSAVANCE in children less than 18 years of age have not been established.
Slovenian: Varnost in učinkovitost zdravila FOSAVANCE pri otrocih, mlajših od 18 let, nista bili dokazani.
English: Hypocalcaemia must be corrected before initiating therapy with FOSAVANCE (see section 4.3).
Slovenian: Hipokalciemijo je treba korigirati pred začetkom zdravljenja z zdravilom FOSAVANCE (glejte poglavje 4.3).
English: • Patients should not lie down for at least 30 minutes after taking FOSAVANCE and until after the first food of the day.
Slovenian: • Bolnik se ne sme uleči še vsaj 30 minut po zaužitju tablete FOSAVANCE in dokler ne zaužije prvega dnevnega obroka hrane.
English: As well as your treatment with FOSAVANCE, your doctor may suggest you make changes to your lifestyle to help your condition, such as:
Slovenian: Poleg zdravljenja z zdravilom FOSAVANCE vam zdravnik lahko svetuje nekaj sprememb v načinu življenja, ki pomagajo pri vaši bolezni.
English: It is important to maintain good oral hygiene when being treated with FOSAVANCE.
Slovenian: Pomembno je, da med zdravljenjem z zdravilom FOSAVANCE vzdržujete dobro ustno higieno.
English: FOSAVANCE is only intended for use in postmenopausal women and therefore it should not be used during pregnancy or in breast-feeding women.
Slovenian: Zdravilo FOSAVANCE je namenjeno le ženskam po menopavzi, zato se ga ne sme uporabljati v času nosečnosti ali dojenja.
English: Although these usually hurt, breaks in the bones of the spine may go unnoticed until they cause height loss.
Slovenian: Kljub temu da so zlomi običajno boleči, pa se zgodi, da se zlomov hrbtenice ne opazi, vse dokler ne povzročijo zmanjšanja telesne višine.
English: What FOSAVANCE is and what it is used for
Slovenian: Kaj je zdravilo FOSAVANCE in za kaj ga uporabljamo
English: • FOSAVANCE should only be swallowed after getting up for the day with a full glass of water (not less than 200 ml).
Slovenian: • Bolnik mora zdravilo FOSAVANCE pogoltniti zjutraj, ko vstane, s polnim kozarcem vode (ne manj kot 200 ml).
English: • you have been told you have trouble absorbing minerals in your stomach or intestines
Slovenian: • če so vam povedali, da imate težave z absorpcijo mineralov v želodcu ali črevesju (sindrom malabsorpcije),
English: Remember, take FOSAVANCE once each week on that same day for as long as your doctor prescribes it.
Slovenian: Zapomnite si - zdravilo FOSAVANCE je treba vzeti le enkrat na teden, vedno na isti dan v tednu, tako dolgo, kot vam ga je predpisal zdravnik.
English: Take one FOSAVANCE tablet once a week.
Slovenian: Vzemite eno tableto FOSAVANCE enkrat na teden.
English: FOSAVANCE should not be used during pregnancy.
Slovenian: Zdravila FOSAVANCE se med nosečnostjo ne sme uporabljati.
English: • unusual fracture of the thigh bone particularly in patients on long-term treatment for osteoporosis may occur rarely.
Slovenian: • redko se lahko pojavijo neobičajni zlomi stegnenice, zlasti pri bolnikih, ki so na dolgotrajnem zdravljenju osteoporoze.
English: When you get out of bed on the day you have chosen, and before taking your first food, drink or other medicines, swallow (do not crush or chew the tablet or allow it to dissolve in your mouth) one FOSAVANCE tablet with a full glass of water (not mineral water).
Slovenian: Ko na izbrani dan zjutraj vstanete in še preden pojeste prvo hrano ali popijete prvo pijačo ali vzamete katero koli drugo zdravilo, pogoltnite (ne zdrobite, ne žvečite in ne raztapljajte v ustih) eno tableto FOSAVANCE s polnim kozarcem vode (ne z mineralno vodo).
English: • allergic reactions such as hives; swelling of the face, lips, tongue and/or throat, possibly causing difficulty breathing or swallowing; severe skin reactions,
Slovenian: • alergijske reakcije, kot so koprivnica, otekanje obraza, ustnic, jezika in/ali žrela, ki lahko otežuje dihanje ali požiranje, hude kožne reakcije
English: 4) Do not take FOSAVANCE at bedtime or before getting up for the day.
Slovenian: 4) Zdravila FOSAVANCE ne jemljite zvečer ali preden zjutraj vstanete.
English: An Instruction Card is included in the carton for FOSAVANCE.
Slovenian: V škatli zdravila FOSAVANCE je priložena kartica z navodili.
English: • Patients should only swallow FOSAVANCE whole.
Slovenian: • Bolnik mora pogoltniti celo tableto FOSAVANCE.
English: FOSAVANCE must be taken with water only (not mineral water) at least 30 minutes before the first food, beverage, or medicinal product (including antacids, calcium supplements and vitamins) of the day.
Slovenian: Zdravilo FOSAVANCE je treba vzeti izključno z navadno vodo (ne z mineralno vodo) najmanj 30 minut pred prvim dnevnim obrokom hrane in pijače ali zaužitjem drugih zdravil (vključno z antacidi, pripravki kalcija in vitamini).
English: Certain medicines for rheumatism or long-term pain called NSAIDs (e.g. acetylsalicylic acid or ibuprofen) might cause digestive problems.
Slovenian: Določena zdravila za zdravljenje revmatičnih obolenj ali dolgotrajne bolečine, imenovana nesteroidni antirevmatiki (NSAID) (npr.: acetilsalicilna kislina ali ibuprofen), lahko povzročijo prebavne motnje.
English: What FOSAVANCE is and what it is used for What you need to know before you take FOSAVANCE How to take FOSAVANCE
Slovenian: Kaj je zdravilo FOSAVANCE in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo FOSAVANCE Kako jemati zdravilo FOSAVANCE Možni neželeni učinki
English: Patients should be instructed that if they miss a dose of FOSAVANCE they should take one tablet on the morning after they remember.
Slovenian: Bolnikom je treba naročiti, naj v primeru, da pozabijo vzeti odmerek zdravila FOSAVANCE, vzamejo eno tableto zjutraj potem, ko se spomnijo.
English: 6) After swallowing your FOSAVANCE tablet, wait at least 30 minutes before taking your first food, drink, or other medicine of the day, including antacids, calcium supplements and vitamins.
Slovenian: 6) Ko pogoltnete tableto FOSAVANCE, vsaj še 30 minut počakajte, preden zaužijete prvo hrano, pijačo ali katero koli drugo zdravilo, vključno z antacidi, dodatki kalcija in vitamini.
English: Other medicines and FOSAVANCE
Slovenian: Druga zdravila in zdravilo FOSAVANCE
English: What you need to know before you take FOSAVANCE
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo FOSAVANCE
English: Studies in animals have shown reproductive toxicity.
Slovenian: Študije na živalih so pokazale škodljiv vpliv na sposobnost razmnoževanja.
English: 5 How to store FOSAVANCE Contents of the pack and other information
Slovenian: Shranjevanje zdravila FOSAVANCE Vsebina pakiranja in dodatne informacije
English: 5) If you develop difficulty or pain upon swallowing, chest pain, or new or worsening heartburn, stop taking FOSAVANCE and contact your doctor.
Slovenian: 5) Če se pojavijo težave ali bolečine pri požiranju, bolečine v prsih, zgaga ali če se težave z zgago stopnjujejo, prenehajte jemati zdravilo FOSAVANCE in se posvetujte z zdravnikom.
English: It is likely that calcium supplements, antacids, and some oral medicines will interfere with the absorption of FOSAVANCE if taken at the same time.
Slovenian: Dodatki kalcija, antacidi in nekatera zdravila, ki jih zaužijete, lahko motijo absorpcijo zdravila FOSAVANCE, če jih vzamete istočasno.
English: This leaflet was last revised in <{MM/YYYY}>
Slovenian: Navodilo je bilo nazadnje revidirano dne
English: If you miss a dose, take only one FOSAVANCE tablet on the morning after you remember.
Slovenian: Če pozabite vzeti odmerek, vzemite le eno tableto FOSAVANCE naslednje jutro, potem ko se spomnite.
English: Studies in animals have shown hypercalcaemia and reproductive toxicity with high doses of vitamin D (see section 5.3).
Slovenian: Študije na živalih so pri velikih odmerkih vitamina D pokazale hiperkalciemijo in škodljiv vpliv na sposobnost razmnoževanja (glejte poglavje 5.3).
English: Irritation, inflammation or ulceration of the gullet (oesophagus - the tube that connects your mouth with your stomach) often with symptoms of chest pain, heartburn, or difficulty or pain upon swallowing may occur, especially if patients do not drink a full glass of water and/or if they lie down less than 30 minutes after taking FOSAVANCE.
Slovenian: Po zaužitju lahko pride do draženja, vnetja ali razjede požiralnika, pogosto z bolečino v prsnem košu, zgago ali oteženim ali bolečim požiranjem, še posebej, če bolnik ne spije polnega kozarca vode in/ali če se uleže prej kot v 30 minutah po zaužitju zdravila FOSAVANCE.
English: FOSAVANCE is only intended for use in postmenopausal women.
Slovenian: Zdravilo FOSAVANCE je namenjeno le ženskam po menopavzi.
English: The mean half-life of vitamin D3 in the serum following an oral dose of FOSAVANCE (70 mg/2,800 IU) is approximately 24 hours.
Slovenian: Povprečni razpolovni čas vitamina D3 v serumu po peroralnem odmerku zdravila FOSAVANCE (70 mg/2.800 i.e.) je približno 24 ur.
English: FOSAVANCE is effective only if taken when your stomach is empty.
Slovenian: Zdravilo FOSAVANCE je učinkovito samo, če ga vzamete na tešče.