FrancophonIA/ELRC3.0 huggingface dataset:
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Ecansya 150 mg film-coated tablets Each film-coated tablet contains 150 mg capecitabine.
Slovenian: Ecansya 150 mg filmsko obložene tablete Ena filmsko obložena tableta vsebuje 150 mg kapecitabina.
English: PRIMARY ANALYSIS XELOX+BV (EPP*: N=967; ITT**: N=1017)
Slovenian: XELOX/XELOX + P/ XELOX + BEVACIZUMAB (EPP*: n = 967; ITT**: n =
English: - EOX: epirubicin (50 mg/m 2 as a bolus on day 1 every 3 weeks), oxaliplatin (130 mg/m 2 given as a 2 hour infusion on day 1 every three weeks), and capecitabine (625 mg/m 2 twice daily continuously).
Slovenian: - EOF: epirubicin (50 mg/m 2 kot bolus 1. dan vsake 3 tedne), oksaliplatin (130 mg/m 2 v 2-urni infuziji 1. dan vsake tri tedne) in 5-FU (200 mg/m 2 na dan v kontinuirani infuziji skozi centralni venski kateter); - EOX: epirubicin (50 mg/m 2 kot bolus 1. dan vsake 3 tedne), oksaliplatin (130 mg/m 2 v 2-urni infuziji 1. dan vsake tri tedne) in kapecitabin (625 mg/m 2 dvakrat na dan neprekinjeno).
English: Joint swelling, Bone pain, Facial pain, Musculoskeletal stiffness, Muscular weakness
Slovenian: Bolezni mišičnoskeletnega sistema in vezivnega tkiva mialgija, artralgija, bolečina v ekstremitetah bolečina v čeljusti, mišični spazmi, trizmus, mišična šibkost
English: Patients treated with XELIRI experienced excessive gastrointestinal toxicity compared with FOLFIRI (diarrhoea 48% and 14% for XELIRI and FOLFIRI respectively).
Slovenian: FOLFIRI (driska 48 % za XELIRI in 14 % za FOLFIRI).
English: Ecansya dose calculations
Slovenian: Odmerek zdravila Ecansya
English: - ECX: epirubicin (50 mg/m 2 as a bolus on day 1 every 3 weeks), cisplatin (60 mg/m 2 as a two hour infusion on day 1 every 3 weeks), and capecitabine (625 mg/m 2 twice daily continuously).
Slovenian: 1. dan vsake 3 tedne) in 5-FU (200 mg/m 2 na dan v kontinuirani infuziji skozi centralni venski kateter); - ECX: epirubicin (50 mg/m 2 kot bolus 1. dan vsake 3 tedne), cisplatin (60 mg/m 2 v 2-urni infuziji 1. dan vsake 3 tedne) in kapecitabin (625 mg/m2 dvakrat na dan neprekinjeno);
English: - History of severe and unexpected reactions to fluoropyrimidine therapy, - Hypersensitivity to capecitabine or to any of the excipients listed in section 6.1 or fluorouracil, - In patients with known complete absence of dihydropyrimidine dehydrogenase (DPD) activity
Slovenian: - Preobčutljivost na kapecitabin, katero koli pomožno snov, navedeno v poglavju 6.1, ali fluorouracil.
English: Data from two multicentre phase II clinical trials support the use of capecitabine monotherapy for treatment of patients after failure of taxanes and an anthracycline-containing chemotherapy regimen or for whom further anthracycline therapy is not indicated.
Slovenian: Samostojno zdravljenje s kapecitabinom po neuspešnem zdravljenju s kemoterapijo, ki je vključevala taksane in antracikline ter zdravljenje bolnikov, za katere antraciklini niso indicirani Podatki dveh multicentričnih kliničnih preskušanj faze II podpirajo samostojno uporabo kapecitabina za zdravljenje bolnikov po neuspelem zdravljenju s taksani in neuspelem zdravljenju z antraciklinsko kemoterapijo ter pri bolnikih, kjer antraciklini niso indicirani.
English: Oxaliplatin on Day 1, every 2 weeks Leucovorin on Days 1 and 2, every 2 weeks
Slovenian: FOLFOX-4 ali FOLFOX-4 + bevacizumab oksaliplatin 85 mg/m intravensko 2 h oksaliplatin 1. dan, vsake 2 tedna levkovorin 1. in 2. dan, vsake 2 tedna
English: 604 patients were randomised to treatment with 5-FU and leucovorin (Mayo regimen: 20 mg/m2 leucovorin intravenous followed by 425 mg/m2 intravenous bolus 5-FU, on days 1 to 5, every 28 days).
Slovenian: V teh študijah so 603 randomizirane bolnike zdravili s kapecitabinom v tritedenskem ciklu jemanja 1.250 mg/m2/dvakrat na dan 14 dni, čemur je sledil enotedenski premor, 604 randomizirane bolnike pa s 5-FU in levkovorinom (shema Mayo: 20 mg/m levkovorina intravensko, sledilo je 425 mg/m2 5-FU v obliki intravenskega bolusa vsakih 28 dni - na prvi do peti dan).
English: Name and address of the manufacturers responsible for batch release Accord Healthcare Ltd.
Slovenian: Accord Healthcare Ltd.
English: Common side effects (may affect up to 1 in 10 people) include: - decreases in the number of white blood cells or red blood cells (seen in tests) - dehydration, weight loss
Slovenian: Pogosti neželeni učinki (pojavijo se lahko pri največ 1 od 10 bolnikov) vključujejo: - zmanjšanje števila belih ali rdečih krvnih celic (ugotovljeno pri preiskavi), - dehidracijo, zmanjšanje telesne mase, - nespečnost (insomnijo), depresijo, - glavobol, zaspanost, omotico, nenormalne občutke v koži (otrplost ali občutek ščemenja),
English: Pharyngitis, Oral candidiasis, Influenza, Gastroenteritis, Fungal infection, Infection, Tooth abscess
Slovenian: Infekcijske in parazitske bolezni okužba z virusom herpesa, nazofaringitis, okužba spodnjih dihal sepsa, okužba sečil, celulitis, tonzilitis, faringitis, oralna kandidoza, gripa, gastroenteritis, glivična okužba, okužba, zobni absces
English: Aluminium/aluminium blisters EU/1/12/763/013 30 film-coated tablets EU/1/12/763/014 60 film-coated tablets EU/1/12/763/015 120 film-coated tablets
Slovenian: EU/1/12/763/013 30 filmsko obloženih tablet EU/1/12/763/014 60 filmsko obloženih tablet EU/1/12/763/015 120 filmsko obloženih tablet
English: Aluminium/aluminium blisters EU/1/12/763/007 30 film-coated tablets EU/1/12/763/008 60 film-coated tablets EU/1/12/763/009 120 film-coated tablets
Slovenian: EU/1/12/763/007 30 filmsko obloženih tablet EU/1/12/763/008 60 filmsko obloženih tablet EU/1/12/763/009 120 filmsko obloženih tablet
English: What you need to know before you take Ecansya 3.
Slovenian: Kaj je zdravilo Ecansya in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Ecansya Kako jemati zdravilo Ecansya Možni neželeni učinki
English: Reproductive system and breast disorders
Slovenian: Motnje reprodukcije in dojk vaginalna krvavitev
English: METHOD AND ROUTE (S) OF ADMINISTRATION Read the package leaflet before use.
Slovenian: Pred uporabo preberite priloženo navodilo!
English: Each film-coated tablet contains 15 mg anhydrous lactose.
Slovenian: Ena filmsko obložena tableta vsebuje 150 mg kapecitabina.
English: • Grade 2 -1st appearance
Slovenian: • Stopnja 2 1. pojav prekinitev, dokler ni dosežena stopnja 0−1
English: Diabetes mellitus or electrolyte disturbances.
Slovenian: - Pri bolnikih s hudo levkopenijo, nevtropenijo ali trombocitopenijo.
English: Aluminium/aluminium blisters EU/1/12/763/001 30 film-coated tablets EU/1/12/763/002 60 film-coated tablets EU/1/12/763/003 120 Film-coated tablets
Slovenian: EU/1/12/763/001 30 filmsko obloženih tablet EU/1/12/763/002 60 filmsko obloženih tablet EU/1/12/763/003 120 filmsko obloženih tablet
English: Neutropenia
Slovenian: Dojenje
English: Intestinal obstruction, Ascites, Enteritis, Gastritis, Dysphagia, Abdominal pain lower, Oesophagitis, Abdominal discomfort, Gastrooesophageal reflux disease, Colitis, Blood in stool
Slovenian: Bolezni prebavil driska, bruhanje, slabost, stomatitis, bolečina v trebuhu krvavitev iz prebavil, zaprtje, bolečina v zgornjem delu trebuha, dispepsija, flatulenca, suha usta črevesna obstrukcija, ascites, enteritis, gastritis, disfagija, bolečina v spodnjem delu trebuha, ezofagitis, nelagodje v trebuhu, gastroezofagealna refluksna bolezen, kolitis, kri v blatu
English: Talc
Slovenian: Lot
English: ITT
Slovenian: Občasni
English: Ecansya 500 mg tablets capecitabine
Slovenian: Ecansya 500 mg filmsko obložene tablete kapecitabin
English: Pulmonary embolism, Pneumothorax, Haemoptysis, Asthma, Dyspnoea exertional
Slovenian: Bolezni dihal, prsnega koša in mediastinalneg a prostora dispneja, epistaksa, kašelj, rinoreja pljučna embolija, pnevmotoraks, hemoptiza, astma, dispneja ob naporu
English: NAME OF THE MARKETING AUTHORISATION HOLDER KRKA
Slovenian: Glavni rezultati učinkovitosti za študijo AIO KRK
English: Ecansya 300 mg tablets capecitabine
Slovenian: Ecansya 300 mg filmsko obložene tablete kapecitabin
English: NAME OF THE MEDICINAL PRODUCT Ecansya 150 mg film-coated tablets capecitabine
Slovenian: Ecansya 150 mg filmsko obložene tablete kapecitabin
English: Flushing, Hypotension, Hypertensive crisis, Hot flush, Phlebitis
Slovenian: Žilne bolezni edem v spodnjih okončinah, hipertenzija, embolizem in tromboza napadi rdečice, hipotenzija, hipertenzivna kriza, vročinski oblivi, flebitis
English: Each film-coated tablet contains 7 mg anhydrous lactose.
Slovenian: Pomožna snov z znanim učinkom Ena filmsko obložena tableta vsebuje 7 mg brezvodne laktoze.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 500 mg capecitabine.
Slovenian: Ena filmsko obložena tableta vsebuje 500 mg kapecitabina.
English: 4 years
Slovenian: 4 leta
English: Elderly women (65 years and older):
Slovenian: Starejše ženske (65 let in starejše):
English: The programme shall include the full text of the SmPC.
Slovenian: Program vključuje celotno besedilo SmPC.
English: Children and adolescents below 18 years of age:
Slovenian: Otroci in mladostniki, mlajši od 18 let:
English: • Not known: frequency cannot be estimated from the available data
Slovenian: • Neznana pogostnost: pogostnosti iz razpoložljivih podatkov ni mogoče oceniti
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 24 February 2009
Slovenian: DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET 24. februar 2009
English: The expiry date refers to the last day of that month.
Slovenian: Datum izteka roka uporabnosti se nanaša na zadnji dan navedenega meseca..
English: Results from one-year trial in Asian subjects
Slovenian: Rezultati enoletnega preskušanja pri Azijkah
English: The following are reasons why this medicine may not be suitable for you.
Slovenian: Spodaj so navedeni razlogi, zakaj bi utegnilo biti to zdravilo za vas neprimerno.
English: If you wish, you may take it with water or another beverage of choice.
Slovenian: Če želite, jo lahko vzamete z vodo ali po želji z drugo pijačo.
English: • CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE
Slovenian: • POGOJI ALI OMEJITVE V ZVEZI Z VARNO IN UČINKOVITO UPORABO
English: • if you could still become pregnant.
Slovenian: • če je še vedno možno, da bi zanosili;
English: Take your next tablet and continue as before.
Slovenian: Vzemite naslednjo tableto in nadaljujte z jemanjem kot običajno.
English: Risk Management Plan
Slovenian: Načrt o obvladovanju tveganja
English: The programme shall convey the following key messages:
Slovenian: Izobraževalni program mora vsebovati naslednja ključna sporočila:
English: You may take it with or without food.
Slovenian: Lahko jo vzamete s hrano ali brez hrane
English: The usual dose is one tablet each day.
Slovenian: Običajen odmerek je ena tableta na dan.
English: You should have this investigated by your doctor.
Slovenian: Tak dogodek bi moral raziskati vaš zdravnik.
English: The programme shall have both electronic and printed form, which are identical in terms of content.
Slovenian: Izobraževalni program bo na voljo tako v elektronski kot v tiskani obliki, pri čemer bo vsebina obeh enaka.
English: • At the request of the EMEA
Slovenian: • na zahtevo Evropske agencije za zdravila (EMEA).
English: In the event of overdose, general supportive measures should be initiated based on the patient's signs and symptoms.
Slovenian: V primeru prevelikega odmerka je treba uvesti splošne podporne ukrepe na podlagi bolničinih znakov in simptomov.
English: All histology findings were benign.
Slovenian: Vsi histološki izvidi so bili benigni.
English: These side effects may occur with certain frequencies, which are defined as follows:
Slovenian: Neželeni učinki se pojavijo z določeno pogostnostjo, ki je določena kot:
English: Your doctor may recommend that you stop treatment at least 3 weeks prior to this time.
Slovenian: Mogoče vam bo zdravnik priporočil, da vsaj 3 tedne prej prekinete zdravljenje.
English: Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Slovenian: Obvestite svojega zdravnika ali farmacevta, če jemljete ali ste pred kratkim jemali katerokoli zdravilo, tudi če ste ga dobili brez recepta.
English: Do not take a double dose to make up for a forgotten tablet.
Slovenian: Ne vzemite dvojnega odmerka, če ste pozabili vzeti prejšnjo tableto.
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency (EMEA) http://www.emea.europa.eu/.
Slovenian: Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila (EMEA) http://www.emea.europa.eu/.
English: Similar results for vaginal pH and MI were observed in the PEARL study.
Slovenian: Podobne rezultate za vaginalni pH in MI so dosegli v študiji PEARL.
English: Most of the side effects that occurred during studies were mild.
Slovenian: Večina neželenih učinkov, ki so se pojavili med študijami, je bila blagih.
English: As per the CHMP Guideline on Risk Management Systems for medicinal products for human use, the updated RMP should be submitted at the same time as the next Periodic Safety Update Report (PSUR).
Slovenian: V skladu s smernicami CHMP za sisteme za obvladovanje tveganja za zdravila za uporabo v humani medicini mora biti posodobljen RMP predložen hkrati z naslednjim rednim posodobljenim poročilom o varnosti zdravila (PSUR).
English: This is because sitting for a long time in the same position may prevent good blood circulation and may increase your risk of blood clots.
Slovenian: To je potrebno zato, ker dolgotrajno sedenje v istem položaju lahko zmanjša prekrvavitev in lahko poveča tveganje za nastanek krvnih strdkov;
English: Other venous thromboembolic events could also occur.
Slovenian: Lahko se pojavijo tudi drugi venski trombembolični dogodki.
English: These changes are not considered to be clinically meaningful.
Slovenian: Ti spremembi ne veljata za klinično pomembni.
English: Overall, the reproductive and developmental effects observed in animals are consistent with the SERM class of compounds.
Slovenian: Na splošno se reprodukcijski in razvojni učinki, ki so jih ugotovili pri živalih, ujemajo s skupino spojin SERM.
English: -All clinical fractures
Slovenian: -Vsi klinični zlomi
English: • if you are pregnant or breast-feeding.
Slovenian: • če ste noseči ali dojite.
English: • CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE IMPOSED ON THE
Slovenian: • POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE, PREDPISANI IMETNIKU
English: • OTHER CONDITIONS
Slovenian: DRUGI POGOJI
English: These differences are not considered to be clinically meaningful.
Slovenian: Te razlike ne veljajo za klinično pomembne.
English: Therefore safety and efficacy have not been studied (see section 5.2).
Slovenian: Zato študije varnosti in učinkovitosti niso izvedli (glejte poglavje 5.2).
English: ** Endometrial hyperplasia events based on investigator reporting rather than histopathology findings and did not require histological confirmation.
Slovenian: **Primeri endometrijske hiperplazije so temeljili na poročanju raziskovalcev, ne na histopatoloških izidih, in zanje ni bila potrebna histološka potrditev.
English: • if you are allergic (hypersensitive) to lasofoxifene or any of the other ingredients of FABLYN.
Slovenian: • če ste alergični (preobčutljivi) na lasofoksifen ali katerokoli sestavino zdravila FABLYN;
English: This programme should focus on interpretation of endometrial biopsy of women treated with FABLYN.
Slovenian: Ta program bo osredotočen predvsem na interpretacijo biopsije endometrija žensk, ki so se zdravile z zdravilom FABLYN.
English: This must be investigated by your doctor before starting treatment.
Slovenian: Pregledati vas mora vaš zdravnik, še preden začnete zdravljenje;
English: It belongs to a group of medicines called Selective Estrogen Receptor Modulators (SERM).
Slovenian: Pripada skupini zdravil, ki se imenujejo selektivni modulatorji estrogenskih receptorjev (SERM).
English: It must be in line with authoritative international guidelines and supported by evidence published in peer reviewed medical journals.
Slovenian: Program mora biti v skladu z verodostojnimi mednarodnimi smernicami in podprt z navedbami v strokovni medicinski periodiki.
English: Do not take FABLYN if you are pregnant or breast-feeding as it might be excreted in mother's milk.
Slovenian: Ne jemljite zdravila FABLYN, če ste noseči ali dojite, ker bi se zdravilo lahko izločalo v materino mleko.
English: Pharmacovigilance system
Slovenian: Sistem farmakovigilance
English: The overall incidence of vaginal bleeding was low (≤ 2.6% in all treatment groups).
Slovenian: Skupna pogostnost vaginalnih krvavitev je bila majhna (≤ 2,6 % v vseh zdravljenih skupinah).
English: The Manufacturer is Pfizer Manufacturing Deutschland GmbH, Heinrich Mack Strasse 35, 89257 Illertissen, Germany.
Slovenian: Izdelovalec je Pfizer Manufacturing Deutschland GmbH, Heinrich Mack Strasse 35, 89257 Illertissen, Nemčija.
English: Lasofoxifene is highly bound to proteins in human plasma (>99%).
Slovenian: Lasofoksifen se v velikem deležu veže na beljakovine v človeški plazmi (>99 %).
English: Abbreviations: n= number of patients; CI = Confidence Intervals a p < 0.0001; b p = 0.0004; c p = 0.0002; d p = 0.0020; e p = 0.0004
Slovenian: Okrajšave: n= število bolnic; CI = intervali zaupanja ap < 0,0001; bp = 0,0004; cp = 0,0002; dp = 0,0020; e p = 0,0004
English: Effects on lipid metabolism and cardiovascular risk:
Slovenian: Učinki na presnovo lipidov in kardiovaskularno tveganje:
English: In each system organ class and frequency, adverse reactions are not presented in order of decreasing seriousness but in alphabetical order.
Slovenian: Pri vsakem organskem sistemu v posamezni skupini pogostnosti neželenih učinkov niso navedene po padajoči resnosti ampak po abecednem redu.
English: OTHER SPECIAL WARNING(S), IF NECESSARY Sealed pack.
Slovenian: DRUGA POSEBNA OPOZORILA, ČE SO POTREBNA Zalepljeno pakiranje.
English: Bone formed during two years' administration of lasofoxifene is of normal quality.
Slovenian: Kost, ki nastane med dveletno uporabo lasofoksifena, je normalne kakovosti.
English: • Within 60 days of an important (pharmacovigilance or risk minimisation) milestone being
Slovenian: • v 60 dneh po doseženem pomembnem mejniku (farmakovigilančnem ali povezanem z
English: In addition, women taking FABLYN should be advised to move about periodically during prolonged travel.
Slovenian: Poleg tega moramo ženskam, ki jemljejo zdravilo FABLYN, svetovati, naj se med dolgotrajnimi potovanji v rednih presledkih nekoliko sprehodijo.
English: Name and address of the manufacturer responsible for batch release Pfizer Manufacturing Deutschland GmbH
Slovenian: Ime in naslov izdelovalca, odgovornega za sproščanje serije Pfizer Manufacturing Deutschland GmbH
English: • Diabetes (typical symptoms are excessive thirst, frequent urination)
Slovenian: • sladkorna bolezen (tipični simptomi so čezmerna žeja, pogosto odvajanje vode);
English: • if you have or have had breast cancer.
Slovenian: • če imate ali ste kdaj prej imeli raka dojke;
English: Lasofoxifene has a half-life of approximately 6 days.
Slovenian: Lasofoksifen ima razpolovni čas približno 6 dni.
English: The recommended dose is one 500 microgram tablet daily.
Slovenian: Priporočeni odmerek je ena 500 mikrogramska tableta na dan.
English: In some asymptomatic patients, hot flushes may occur upon beginning therapy.
Slovenian: Pri nekaterih bolnicah brez simptomov se lahko po začetku zdravljenja pojavijo vročinski oblivi.
English: Absorption:
Slovenian: Absorpcija:
English: The MAH shall also provide access to educational programme for pathologists.
Slovenian: Imetnik dovoljenja za promet z zdravilom bo zagotovil dostop do izobraževalnega programa tudi patologom.
English: Adult (postmenopausal women):
Slovenian: Odrasle bolnice (ženske v postmenopavzi):
English: Although all of these tumours are believed to be the result of rodent-specific hormonal mechanisms, their relevance for humans is currently unknown.
Slovenian: Ti tumorji so verjetno posledica hormonskih mehanizmov, ki so značilni za glodalce, vendar pa njihovega pomena pri človeku trenutno ne poznamo.
English: 5-year results from large, multinational fracture trial (PEARL)
Slovenian: 5-letni rezultati velikega multinacionalnega preskušanja zlomov (PEARL)
English: Effects on vulvar and vaginal atrophy (VVA):
Slovenian: Učinki na atrofijo vulve in vagine (VVA-vulvar and vaginal atrophy):
English: Adverse reactions are listed by system organ class and frequency (very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100) and rare (≥1/10,000 to <1/1,000)).
Slovenian: Opisani neželeni učinki so navedeni spodaj po organskem sistemu in pogostnosti (zelo pogosti (≥1/10), pogosti (≥1/100 do <1/10), občasni (≥1/1.000 do <1/100)> in redki (≥1/10.000 do <1/1.000)).
English: Name and address of the manufacturer of the biological active substance Not applicable
Slovenian: Ime in naslov izdelovalca biološke zdravilne učinkovine Navedba smiselno ni potrebna
English: Effects on the endometrium:
Slovenian: Učinki na endometrij:
English: Taking FABLYN with food and drink
Slovenian: Jemanje zdravila FABLYN skupaj s hrano in pijačo
English: Any unexplained vaginal bleeding should be investigated as clinically indicated.
Slovenian: Vsako nepojasnjeno krvavitev iz nožnice je treba ustrezno klinično raziskati.
English: Due to the chronic nature of the disease process, FABLYN is intended for long-term use (see section 5.1).
Slovenian: Zaradi kronične narave bolezenskega procesa je zdravilo FABLYN namenjeno za dolgotrajno uporabo (glejte poglavje 5.1).
English: Linearity/non-linearity:
Slovenian: Linearnost/nelinearnost:
English: Therefore, FABLYN should be used for the treatment of osteoporosis only after the treatment of breast cancer, including adjuvant therapy, has been completed.
Slovenian: Zato smemo zdravilo FABLYN uporabiti za zdravljenje osteoporoze šele potem, ko je zdravljenje raka dojke, vključno z dopolnilnim zdravljenjem, končano.
English: The apparent volume of distribution (V/F) of lasofoxifene in postmenopausal women is approximately 1,350 l.
Slovenian: Navidezni volumen porazdelitve (V/F) lasofoksifena pri ženskah v postmenopavzi je približno 1.350 l.
English: Table 2: Fracture incidence in postmenopausal women over 5 years
Slovenian: Preglednica 2: Pogostnost zlomov pri ženskah v postmenopavzi v obdobju 5 let
English: • Tiredness, abnormal or excessive bleeding commonly from the nose
Slovenian: • utrujenost, nenormalna ali čezmerna krvavitev, navadno iz nosu;
English: Treatment with FABLYN can be restarted as soon as you regain your mobility and in consultation with your doctor.
Slovenian: Zdravljenje z zdravilom FABLYN se lahko začne, takoj ko se spet začnete gibati, prej pa se posvetujte s svojim zdravnikom;
English: Pharmacotherapeutic group: Selective Estrogen Receptor Modulator (SERM), ATC code: {not yet assigned}
Slovenian: Farmakoterapevtska skupina: Selektiven modulator estrogenskih receptorjev (SERM), oznaka ATC: {not yet assigned}
English: • Pressure in the lower abdomen
Slovenian: • pritisk v spodnjem delu trebuha;
English: No studies on the effects on the ability to drive and use machines have been performed.
Slovenian: Študij o vplivu na sposobnost vožnje in upravljanja s stroji niso izvedli.
English: • if you are taking FABLYN, you should walk around or exercise your legs and feet at regular intervals when traveling long distances.
Slovenian: • če jemljete zdravilo FABLYN, se morate med dolgimi potovanji občasno sprehoditi ali v rednih presledkih razgibati noge in stopala.
English: You should talk to your doctor before starting to take FABLYN:
Slovenian: Pogovorite se s svojim zdravnikom, preden začnete jemati zdravilo FABLYN:
English: • Dry mouth, flatulence (excessive amount of air or gases in the stomach or the intestine),
Slovenian: • suha usta, vetrovi (čezmerna količina zraka ali plinov v želodcu ali črevesu), bolečina v želodcu;
English: The tablets are provided in blister packs containing 7, 28 or 30 tablets, and in bottle packs containing 90 tablets.
Slovenian: Tablete so na voljo v pretisnih omotih, ki vsebujejo 7, 28 ali 30 tablet, in v plastenkah, ki vsebujejo 90 tablet.