FrancophonIA/ELRC3.0 huggingface dataset:
English: No dose adjustment for FABLYN is necessary in elderly patients.
Slovenian: Pri starejših bolnicah prilagajanje odmerka zdravila FABLYN ni potrebno.
English: • Hot flush
Slovenian: • vročinski obliv;
English: There were 0.51 events/100 patient-years for FABLYN-treated patients compared to 0.75 events/100 patient-years in placebo-treated patients (HR 0.68; 95% CI 0.50, 0.93, p= 0.016).
Slovenian: Pri bolnicah, zdravljenih z zdravilom FABLYN, je bilo 0,51 dogodka/100 bolnikov-let, pri bolnicah, ki so dobivale placebo, pa 0,75 dogodka/100 bolnikov-let (HR 0,68; 95 % CI 0,50, 0,93, p= 0,016).
English: Triacetin
Slovenian: Čet
English: FABLYN significantly decreased the incidence of all clinical fractures from 12.1% for placebo to 9.3% for FABLYN (relative risk reduction = 25%, p = 0.0004).
Slovenian: Zdravilo FABLYN je signifikantno zmanjšalo pogostnost vseh kliničnih zlomov z 12,1 % pri placebu na 9,3 % pri zdravilu FABLYN (relativno zmanjšanje tveganja = 25 %, p = 0,0004).
English: • Common: affects 1 to 10 users in 100
Slovenian: • Pogosti: pojavijo se pri 1 do 10 bolnikih od 100 bolnikov
English: • Rare: affects 1 to 10 users in 10,000
Slovenian: • Redki: pojavijo se pri 1 do 10 bolnikih od 10.000 bolnikov
English: Significantly fewer women experienced multiple radiographic vertebral fractures in the FABLYN treatment group versus the placebo group throughout 5 years of dosing (p < 0.0001).
Slovenian: V skupini, zdravljeni z zdravilom FABLYN, je dobilo v 5 letih zdravljenja po več rentgenskih vretenčnih zlomov signifikantno manj žensk kot v skupini s placebom (p < 0,0001).
English: In women with a prevalent vertebral fracture at baseline, FABLYN significantly reduced the incidence of new vertebral radiographic fractures from 14.2% for placebo to 8.7% for FABLYN (relative risk reduction = 42%, p = 0.0004).
Slovenian: Pri ženskah s prevladujočim vretenčnim zlomom v izhodišču je zdravilo FABLYN signifikantno zmanjšalo pogostnost novih rentgenskih vretenčnih zlomov s 14,2 % pri placebu na 8,7 % pri zdravilu FABLYN (relativno zmanjšanje tveganja = 42 %, p = 0,0004).
English: There is no indication for FABLYN in children and adolescents below 18 years of age since the medicinal product is for use in postmenopausal women only.
Slovenian: Ker se zdravilo FABLYN uporablja pri ženskah v postmenopavzi, ni indicirano pri otrocih in mladostnikih, mlajših od 18 let.
English: Uncommon: Micturition urgency, nocturia, pollakiuria, urethral disorder, urinary incontinence Rare:
Slovenian: Občasni: nenadna močna želja po uriniranju, nikturija, polakisurija, obolenje uretre, urinska inkontinenca
English: • Dry eye, hair loss, skin rash, night sweats, itching, feeling hot, weight gain
Slovenian: • suhe oči, izpadanje las, kožni izpuščaj, nočno potenje, srbenje, občutek vročine, porast telesne mase;
English: FABLYN significantly decreased the incidence of non-vertebral fractures from 10.4% for placebo to 8.1% for FABLYN (relative risk reduction = 24%, p = 0.0020).
Slovenian: Zdravilo FABLYN je signifikantno zmanjšalo pogostnost nevretenčnih zlomov z 10,4 % pri placebu na 8,1 % pri zdravilu FABLYN (relativno zmanjšanje tveganja = 24 %, p = 0,0020).
English: NAME OF THE MEDICINAL PRODUCT FABLYN 500 microgram film-coated tablets.
Slovenian: IME ZDRAVILA FABLYN 500 mikrogramov filmsko obložene tablete
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION FABLYN 500 microgram film-coated tablets lasofoxifene
Slovenian: IME ZDRAVILA IN POT(I) UPORABE FABLYN 500 mikrogramov filmsko obložene tablete lasofoksifen peroralna uporaba
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS BOTTLE LABEL
Slovenian: PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
English: photosensitivity reaction, pruritus generalized, rash maculo-papular, rash pruritic,
Slovenian: preobčutljivostna reakcija na svetlobo, generalizirani pruritus, makulopapularen izpuščaj,
English: Safety and efficacy of lasofoxifene have not been evaluated in patients with severe renal insufficiency; therefore, FABLYN should be used with caution in these patients.
Slovenian: Varnosti in učinkovitosti lasofoksifena niso ovrednotili pri bolnicah s hudo insuficienco ledvic, zato je treba pri teh bolnicah zdravilo FABLYN uporabljati previdno.
English: FABLYN significantly decreased the incidence of new radiographic vertebral fractures (excluding worsening of previous fractures) from 9.3% for placebo to 5.6% for FABLYN (relative risk reduction = 41%, p < 0.0001).
Slovenian: Zdravilo FABLYN je signifikantno zmanjšalo pogostnost novih rentgensko ugotovljenih vretenčnih zlomov (poslabšanje že od prej obstoječih zlomov tu ni vključeno) z 9,3 % pri placebu na 5,6 % pri zdravilu FABLYN (relativno zmanjšanje tveganja = 41 %, p < 0,0001).
English: No dose adjustment is necessary in patients with mild or moderate renal insufficiency (see section 5.2).
Slovenian: Pri bolnicah z blago ali zmerno insuficienco ledvic prilagajanje odmerka ni potrebno (glejte poglavje 5.2).
English: No dose adjustment for FABLYN is necessary for patients with mild or moderate renal insufficiency (see section 4.4).
Slovenian: Pri bolnicah z blago ali zmerno insuficienco ledvic ni potrebno prilagajanje odmerka zdravila FABLYN (glejte poglavje 4.4).
English: Increased incidence of imperforate anus, hypoplastic tail, edema and limb flexures noted in fetuses of pregnant rats dosed at 100 mg/kg (approximately 400 times the AUC in humans) were associated with increased embryo-fetal lethality and generalized failure to thrive.
Slovenian: Pri zarodkih brejih podgan, ki so prejele odmerek 100 mg/kg (AUC, približno 400-krat večja kot pri ljudeh) so opazili povečano pogostnost atrazije anusa, hipoplazije repa, edema in upogiba okončine, ki je bila povezana s povečano embrio-fetalno smrtnostjo in splošno nezmožnostjo razvoja.
English: Very common side effects:
Slovenian: Zelo pogosti neželeni učinki:
English: Common: Constipation
Slovenian: Pogosti: vročinski obliv
English: Safety and efficacy of FABLYN have not been evaluated in patients with liver function test > 1.5 ULN; therefore, FABLYN should be used with caution in these patients.
Slovenian: Varnosti in učinkovitosti zdravila FABLYN niso ovrednotili pri bolnicah z okvarjenim delovanjem jeter (vrednost ULN > 1,5), zato je treba zdravilo FABLYN pri teh bolnicah uporabljati previdno.
English: NAME OF THE MEDICINAL PRODUCT FABLYN 500 microgram film-coated tablets lasofoxifene
Slovenian: FABLYN 500 mikrogramov filmsko obložene tablete lasofoksifen
English: Lactose anhydrous
Slovenian: Pogosti: hiperhidroza
English: Titanium dioxide (E171)
Slovenian: Obloga tablete: oranžno FCF (E110) hipromeloza laktoza monohidrat titanov dioksid (E171) triacetin
English: No dose adjustment is required in patients with mild to moderate hepatic insufficiency (see section 5.2).
Slovenian: Pri bolnicah z blago do zmerno insuficienco jeter prilagajanje odmerka ni potrebno (glejte poglavje 5.2).
English: No clinically meaningful differences in lasofoxifene pharmacokinetic were observed over the age range of 40 to 80 years of age based on the results of a population pharmacokinetic analysis.
Slovenian: Med 40. in 80. letom starosti pri rezultatih populacijske farmakokinetične analize niso opazili klinično pomembnih razlik v farmakokinetiki lasofoksifena.
English: In women without any prevalent vertebral fractures at baseline, the incidence of new radiographic vertebral fractures was significantly reduced from 7.4% for placebo to 4.4% for FABLYN (relative risk reduction = 41%, p = 0.0002).
Slovenian: Pri ženskah brez prevladujočih vretenčnih zlomov v izhodišču se je pomembno zmanjšala pogostnost novih rentgenskih vretenčnih zlomov s 7,4 % pri placebu na 4,4 % pri zdravilu FABLYN (relativno zmanjšanje tveganja = 41 %, p
English: In fertility studies conducted in rats with lasofoxifene, slight effects on male reproductive performance occurred at ≥10 mg/kg/day (approximately 42 times the AUC in humans) as evidenced by decreases in copulation index, implantation sites, and fetuses sired.
Slovenian: V študijah plodnosti, ki so jih z lasofoksifenom opravili na podganah, so se pri odmerku ≥10 mg/kg/dan (AUC, približno 42-krat večja od kot ljudeh) pojavili neznatni učinki na reprodukcijsko storilnost samcev, kar je pokazalo zmanjšanje kopulacijskega indeksa, implantacijskih mest in plodov; pri samicah, ki so prejemale zdravilo v odmerkih ≥0,01 mg/kg/dan (pod ravnjo sistemske izpostavljenosti pri ljudeh), pa so ugotovili zmanjšano plodnost in zvečanje predimplantacijskih in postimplantacijskih izgub, kar je povzročilo manjše zarode in dolgotrajnejšo brejost.
English: Postmenopausal women require an average of 1,500 mg/day of elemental calcium.
Slovenian: Ženske v postmenopavzi potrebujejo povprečno po 1.500 mg elementarnega kalcija na dan. Priporočeni vnos vitamina D je 400-800 i.e. na dan.
English: SUBSTANCE AND MANUFACTURING AUTHORISATION
Slovenian: Imetnik dovoljenja za promet z zdravilom in izdelovalec
English: • Cough, difficulty breathing, stuffy nose, runny nose
Slovenian: • kašelj, oteženo dihanje, zamašen nos, nahod;
English: Elderly:
Slovenian: Presnova:
English: Rare side effects:
Slovenian: Redki neželeni učinki:
English: Within this study, 3.2% of FABLYN-treated women and 8.0% of placebo-treated women discontinued therapy due to adverse events.
Slovenian: Zaradi neželenega učinka so zdravljenje prekinili pri 3,2 % žensk, zdravljenih z zdravilom FABLYN, in pri 8,0 % žensk, izpostavljenih placebu.
English: Always take FABLYN exactly as your doctor has told you.
Slovenian: Pri jemanju zdravila FABLYN natančno upoštevajte zdravnikova navodila.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON FOR BLISTER PACK (7 film-coated tablets)
Slovenian: PODATKI NA ZUNANJI OVOJNINI ŠKATLA ZA PRETISNE OMOTE (7 filmsko obloženih tablet)
English: RELEASE
Slovenian: Sre
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON FOR BLISTER PACK (30 film-coated tablets)
Slovenian: PODATKI NA ZUNANJI OVOJNINI ŠKATLA ZA PRETISNE OMOTE (30 filmsko obloženih tablet)
English: • Impaired vision, pain in eyes, itchy eyes, swollen eyelids, redness of the eyes, ear pain • Lip lesions, change of bowel habits, difficulty swallowing, mouth ulcer, heart burn, mouth pain,
Slovenian: • motnje vida, bolečine v očeh, srbenje oči, otekle očesne veke, rdečina oči, bolečina v ušesu;
English: • Printed on paper
Slovenian: o na medmrežju o na zgoščenki (CD-ROM) o v papirni obliki
English: BATCH NUMBER Lot:
Slovenian: ŠTEVILKA SERIJE Serija:
English: • Uncommon: affects 1 to 10 users in 1,000
Slovenian: • Občasni: pojavijo se pri 1 do 10 bolnikih od 1.000 bolnikov
English: Contains lactose See the package leaflet for further information.
Slovenian: Za dodatne informacije glejte navodilo za uporabo.
English: • Jaundice (yellowing of the skin and eyes), changes in blood tests of liver function • Dry skin, unusual hair texture, nail disorder, skin rash, skin darkening, altered shape of fingers,
Slovenian: • suha koža, neobičajnost las na otip, bolezen nohtov, kožni izpuščaj, potemnitev kože,
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON FOR BOTTLE PACK (90 film-coated tablets)
Slovenian: PODATKI NA ZUNANJI OVOJNINI ŠKATLA ZA PLASTENKO (90 filmsko obloženih tablet)
English: • if you have any vaginal bleeding.
Slovenian: • če imate ali ste imeli krvavitev iz nožnice.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON FOR BLISTER PACK (28 film-coated tablets)
Slovenian: PODATKI NA ZUNANJI OVOJNINI ŠKATLA ZA PRETISNE OMOTE (28 filmsko obloženih tablet)
English: Ear discomfort, inner ear disorder, vertigo positional Cardiac disorders
Slovenian: Redki: bolečina v ušesu, bolezen notranjega ušesa, položajna vrtoglavica Srčne bolezni
English: • Swelling of hands, arms, feet or legs, limb pain
Slovenian: • otekanje dlani, zgornjih udov, stopal ali spodnjih udov, bolečine v udih;
English: Amnesia, dementia Alzheimer's type, dizziness postural, dysgeusia, epilepsy, hydrocephalus, hypogeusia, memory impairment, migraine, migraine with aura, motor neurone disease, nerve compression, paresis, presyncope, sciatica, vascular headache Eye disorders Uncommon: Dry eye Rare:
Slovenian: vodenoglavost, hipogevzija, spominske motnje, migrena, migrena z avro, amiotrofična lateralna skleroza, kompresija živca, pareza, presinkopa, išias, vaskularni glavobol Očesne bolezni
English: Safety and efficacy of lasofoxifene have not been evaluated in patients with hepatic insufficiency with liver function test > 1.5 ULN; therefore, FABLYN should be used with caution in these patients.
Slovenian: Varnosti in učinkovitosti lasofoksifena niso ovrednotili pri bolnicah z insuficienco jeter, ki so imele vrednost zgornje normalne meje (ULN) večjo od 1,5; zato je treba zdravilo FABLYN pri teh bolnicah uporabljati previdno.
English: Vaginal discharge occurred in about one in 26 patients.
Slovenian: Izcedek iz nožnice se je pojavil približno pri eni od 26 bolnic, ki so jemale zdravilo FABLYN.
English: Significant increases in BMD were observed as early as 3 months for lumbar spine and total hip.
Slovenian: V ledveni hrbtenici in celotnem kolku so opazili signifikanten porast BMD že po 3 mesecih.
English: stomach ache
Slovenian: Bolezni sečil
English: • if you experience any unexplained breast abnormality.
Slovenian: • če opazite na dojkah kaj nenavadnega, kar si ne znate razložiti;
English: No dose adjustment for FABLYN is necessary for patients with mild or moderate hepatic insufficiency.
Slovenian: Pri bolnicah z blago ali zmerno insuficienco jeter ni potrebno prilagajanje odmerkov zdravila FABLYN.
English: You should check with your doctor or pharmacist if you are not sure.
Slovenian: Če ste negotovi, se posvetujte z zdravnikom ali s farmacevtom.
English: 7 film-coated tablets
Slovenian: FARMACEVTSKA OBLIKA IN VSEBINA 7 filmsko obloženih tablet
English: Anorexia, decreased appetite, hypertriglyceridaemia, hypoalbuminaemia,
Slovenian: Redki: anoreksija, zmanjšan tek, hipertrigliceridemija, hipoalbuminemija, hipofosfatemija, zvečan tek, tetanija, diabetes mellitus tipa 2
English: Common: Cystocele, endometrial disorder, endometrial hypertrophy* (sonographic endometrial thickness), uterine polyp, vaginal discharge, vaginal disorder Uncommon: Breast disorder female, breast induration, breast pain, cervix disorder, cervical dysplasia, cervical polyp, colpocele, endometrial hyperplasia** (based on investigator reporting), genital discharge, genital haemorrhage, hydrometra, metrorrhagia, postmenopausal haemorrhage, rectocele, uterine cervical erosion, uterine prolapse, vaginal haemorrhage, vaginal prolapse, vulvovaginal pruritus
Slovenian: Motnje reprodukcije in dojk Pogosti: cistokela, bolezni endometrija, hipertrofija endometrija* (ultrazvočno ugotovljena zadebelitev endometrija), maternični polip, izcedek iz nožnice, bolezni nožnice Občasni: bolezen dojke, induracija dojke, bolečina v dojki, bolezen materničnega vratu, cervikalna displazija, cervikalni polip, kolpokela, endometrijska hiperplazija** (na podlagi poročanja raziskovalcev), izcedek iz spolovil, genitalna krvavitev, hidrometra, metroragija, postmenopavzna krvavitev, rektokela, erozija materničnega vratu, prolaps maternice, krvavitev iz nožnice, prolaps nožnice, vulvovaginalni pruritus Redki: adenomioza, cista materničnih adneksov, masa v materničnih adneksih, izcedek iz dojke, nabreklost dojk, fibroza dojk, zvečan ščegetavček, cista jajcevoda, bolezen bradavice, bolečina v bradavici, perinealna laceracija, genitalni pruritus, skvamozna metaplazija materničnega vratu, krvavitev iz maternice, masa v maternici, vaginalna erozija, vnetje nožnice, bolečina v nožnici, kongestija vaginalne stene, vulvarne varice, bolezen vulve Prirojene, dedne in genetske okvare Redki:: venska malformacija Splošne težave in spremembe na mestu aplikacije Pogosti: nepričakovan odziv na zdravljenje Občasni: bolečina v prsih, utrujenost, občutek vročine, periferni edemi Redki: nelagodje v prsih, občutek pijanosti, hipertermija, vnetje, masa, edem, polip Preiskave Pogosti: zvišana aspartat-aminotransferaza Občasni: zvišana alanin-aminotransferaza, zvišana glukoza v krvi, nenormalen cervikalni bris, zvišane transaminaze, zvečana telesna masa Redki: zvišana 5-nukleotidaza, znižan albumin v krvi, nenormalen kreatinin v krvi, zvišani trigliceridi v krvi, prisotnost krvi v urinu, zmanjšana kostna gostota, nenormalna rentgenska slika pljuč in srca, nenormalen zobec T v elektrokardiogramu, zvišana gamaglutamiltransferaza, pozitiven površinski antigen hepatitisa B, znižan lipoprotein velike gostote, zvišan lipoprotein majhne gostote, oslabljen pulz na nogi, znižana koncentracija trombocitov, nenormalen ultrazvok dojke, nenormalen ultrazvok jajčnika Poškodbe in zastrupitve in zapleti pri posegih Redki: ekskoriacija, genitalna poškodba, poškodbe udov, poškodbe kosti, poškodbe mehkih tkiv, zlom hrbtenice, zlom prsnega vretenca, zlom zoba
English: Bile duct stone, cholecystitis, hepatitis, jaundice, liver disorder Skin and subcutaneous tissue disorders Common Hyperhidrosis
Slovenian: Redki: kamen v žolčevodu, holecistitis, hepatitis, zlatenica, bolezen jeter Bolezni kože in podkožja
English: Arthritis infective, bronchitis, cellulitis, cervicitis, diverticulitis, fungal infection, furuncle, genital candidiasis, herpes simplex ophthalmic, impetigo, labyrinthitis,
Slovenian: Občasni: infekcija sečil, kandidiaza nožnice, infekcije nožnice, vulvovaginitis Redki: infekcijski artritis, bronhitis, celulitis, cervicitis, divertikulitis, glivične infekcije, furunkel,
English: Aphakia, chorioretinopathy, conjunctival haemorrhage, conjunctival hyperaemia, eye haemorrhage, eye pruritus, eyelid oedema, keratoconjunctivitis sicca, macular degeneration, ocular hyperaemia, pupils unequal, retinal detachment, retinal vascular disorder, retinopathy, visual acuity reduced, visual disturbance Ear and labyrinth disorders
Slovenian: Redki: afakija, horioretinopatija, konjunktivalna krvavitev, konjunktivalna hiperemija, očesna krvavitev, očesni pruritus, edem očesne veke, suhi keratokonjunktivitis, makularna degeneracija, očesna hiperemija, neenaki zenici, odstop mrežnice, bolezen mrežničnih žil,
English: Lasofoxifene exhibits linear pharmacokinetics over a wide dose range following single-dose (up to 100 mg) and multiple-dose (up to 20 mg once daily) administration.
Slovenian: Po dajanju enkratnega odmerka (do 100 mg) in večkratnih odmerkov (do 20 mg enkrat na dan) kaže lasofoksifen linearno farmakokinetiko v širokem razponu odmerkov.
English: 28 film-coated tablets
Slovenian: FARMACEVTSKA OBLIKA IN VSEBINA 28 filmsko obloženih tablet
English: Abdominal tenderness, anal fissure, anal spasm, cheilitis, cheilosis, colitis ulcerative, duodenal ulcer, duodenitis, dysphagia, gastric polyps, inguinal hernia, mouth ulceration, oesophagitis, oral pain, rectal polyp, rectal ulcer, stomach discomfort Hepatobiliary disorders Uncommon: Cholelithiasis, hepatic steatosis Rare:
Slovenian: razjeda dvanajstnika, duodenitis, disfagija, želodčni polipi, dimeljska kila, razjede ustne sluznice, ezofagitis, bolečina v ustih, rektalni polip, rektalni ulkus, želodčne težave Bolezni jeter, žolčnika in žolčevodov
English: Uncommon side effects:
Slovenian: Občasni neželeni učinki:
English: Renally impaired patients:
Slovenian: Bolnice z okvarami ledvic:
English: Blood and lymphatic system disorders Uncommon: Anaemia, macrocytosis, thrombocytopenia Rare:
Slovenian: Občasni: anemija, makrocitoza, trombocitopenija
English: Uncommon: Abdominal pain, abdominal pain lower, abdominal pain upper, dry mouth, flatulence,
Slovenian: Občasni: bolečina v trebuhu, bolečina v spodnjem delu trebuha, bolečina v zgornjem delu trebuha,
English: Angioedema, dry skin, hair texture abnormal, nail disorder, onychoclasis,
Slovenian: Občasni: plešavost, eritem, nočno potenje, pruritus Redki: angioedem, suha koža, nenormalna tekstura las, bolezen nohtov, onihoklazija,
English: • Breast stiffening, breast pain, vaginal bleeding, genital itching
Slovenian: • nabreklost dojk, bolečina v dojkah, krvavitev iz nožnice, srbenje spolovil.
English: Benign breast neoplasm, breast fibroma, chronic lymphocytic leukaemia, endometrial neoplasm, female reproductive neoplasm, haemangioma, hepatic neoplasm malignant, leiomyoma, melanocytic naevus, multiple myeloma, neoplasm, parathyroid tumour
Slovenian: Redki: benigne novotvorbe dojk, fibrom dojke, kronična limfocitna levkemija, novotvorbe endometrija, novotvorbe ženskih genitalij, hemangiom, maligna novotvorba jeter ,
English: EXPIRY DATE
Slovenian: DRUGI PODATKI Pon
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER 7 tablets
Slovenian: PRETISNI OMOT - 7 tablet
English: Aortic aneurysm, arterial occlusive disease, capillary disorder, embolism, haematoma, haemorrhage, intermittent claudication, lymphostasis, thrombosis, vascular stenosis, venous thrombosis, venous thrombosis limb Respiratory, thoracic and mediastinal disorders Uncommon: Cough, pulmonary embolism, rhinitis allergic Rare:
Slovenian: Redki: aortna anevrizma, okluzivna bolezen arterij, bolezen kapilar, embolizem, hematom, krvavitev, intermitentna klavdikacija, limfostaza, tromboza, stenoza žil, venska tromboza,
English: 30 film-coated tablets
Slovenian: FARMACEVTSKA OBLIKA IN VSEBINA 30 filmsko obloženih tablet
English: Silica, colloidal anhydrous
Slovenian: Občasni: holelitiaza, jetrna steatoza
English: What FABLYN is and what it is used for 2.
Slovenian: Kaj je zdravilo FABLYN in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo FABLYN
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER 28 tablets
Slovenian: PRETISNI OMOT - 28 tablet
English: Skeletal effects:
Slovenian: Učinki na kosti:
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER 30 tablets
Slovenian: PRETISNI OMOT - 30 tablet
English: rosacea, skin irritation, skin lesion, skin hyperpigmentation, skin oedema, urticaria Musculoskeletal, connective tissue and bone disorders Very common:
Slovenian: srbeč izpuščaj, rozacea, draženje kože, kožna lezija, hiperpigmentacija kože, edem kože,
English: Metabolism and nutrition disorders Uncommon: Diabetes mellitus Rare:
Slovenian: Bolezni mišično-skeletnega sistema in vezivnega tkiva Zelo pogosti:
English: Hepatically impaired patients:
Slovenian: Starejše bolnice:
English: Lactose monohydrate
Slovenian: Redki: hiperparatiroidizem
English: You should talk to your doctor before stopping FABLYN.
Slovenian: KAJ MORATE VEDETI, PREDEN BOSTE VZELI ZDRAVILO FABLYN
English: Uncommon: Burning sensation, cerebral infarction, headache, restless legs syndrome Rare:
Slovenian: Redki: popuščanje srca, kardiomegalija, pljučno srce, sinusni zastoj, supraventrikularne ekstrasistole, insuficienca trikuspidalne zaklopke
English: DATE OF REVISION OF THE TEXT <{MM/YYYY}>
Slovenian: DATUM ZADNJE REVIZIJE BESEDILA
English: Calculus bladder, hypercalciuria, hypertonic bladder, nephrosclerosis, urethral haemorrhage, urinary bladder polyp, urinary tract disorder Reproductive system and breast disorders
Slovenian: Redki: kalkulozni mehur, hiperkalciurija, hipertonični mehur, nefroskleroza, uretralna krvavitev,
English: Arthropathy, bursitis, clubbing, coccydynia, costochondritis, dactylitis, exostosis, extremity contracture, haemarthrosis, joint stiffness, muscle contracture, muscle twitching, musculoskeletal discomfort, pain in jaw, periarthritis, rheumatoid arthritis,
Slovenian: eksostoza, kontraktura uda, hemartroza, otrdelost sklepa, kontraktura mišice, trzanje mišice,
English: Rare:
Slovenian: Otroci:
English: Keep out of the reach and sight of children.
Slovenian: Zdravilo shranjujte nedosegljivo otrokom!
English: Croscarmellose sodium
Slovenian: Občasni: diabetes mellitus
English: EU/1/13/848/001 Erivedge
Slovenian: EU/1/13/848/001
English: 28 capsules
Slovenian: 28 kapsul
English: Oral use bottle (HDPE)
Slovenian: 150 mg trda kapsula peroralna uporaba plastenka (HDPE)
English: MA (EU) Number (Invented) name Strength Pharmaceutical Form Route of Administration
Slovenian: (Izmišljeno) ime Jakost
English: Pack size
Slovenian: Erivedge
English: Date of first authorisation: 15 March 2010 Date of latest renewal: 19 November 2014
Slovenian: Datum prve odobritve: 15. marec 2010 Datum zadnjega podaljšanja: 19. novembra 2014
English: 2 years.
Slovenian: 2 leti.