natgillin/translations-raw huggingface dataset:
In the same study at 5 years, there was no increase in the risk of stroke including hemorrhagic, ischemic, embolic stroke, stroke type unspecified and transient ischemic attacks in FABLYN-treated patients.
V isti študiji pri bolnicah, zdravljenih z zdravilom FABLYN, po 5 letih ni poraslo tveganje za možgansko kap, vključno s hemoragično, ishemično, embolično kapjo, nedoločeno vrsto možganske kapi in tranzitornimi ishemičnimi atakami.
Placebo-treated women had a 0.7 mm mean decrease from baseline in endometrial thickness over 3 years, whereas the FABLYN-treated women had a 1.4 mm mean increase.
Pri ženskah, ki so prejemale placebo, se je v obdobju 3 let debelina endometrija zmanjšala povprečno za 0,7 mm od izhodiščne debeline, pri ženskah, zdravljenih z zdravilom FABLYN, pa se je za povprečno 1,4 mm zvečala.
Endocrine disorders
Bolezni endokrinega sistema
In clinical practice, these benign findings do not warrant further evaluation in women with no vaginal bleeding, in accordance with guidelines for postmenopausal women (see section 4.4).
V klinični praksi ti benigni izvidi, v skladu s smernicami za ženske v postmenopavzi, ne upravičujejo nadaljnjih diagnostičnih postopkov pri ženskah, ki nimajo krvavitev iz nožnice (glejte poglavje 4.4).
The effects of FABLYN on bone are manifested as reductions in the serum and urine levels of bone turnover markers, increases in bone mineral density (BMD), and decreases in incidence of fractures.
Delovanje zdravila FABLYN na kost se kaže kot znižanje koncentracije označevalcev premene kostnine v serumu in urinu, zvečanje mineralne gostote kosti (BMD-Bone Mineral Density) in zmanjšanje pogostnosti zlomov
Muscle spasms occurred in about one in 9 patients .
Mišični spazmi so se pojavili približno pri eni od 9 bolnic, ki so jemale zdravilo FABLYN.
More FABLYN-treated patients (7.0%) had a diagnostic procedure compared to placebo-treated patients (2.7%).
Tak diagnostičen postopek je imelo več bolnic, zdravljenih z zdravilom FABLYN (7,0 %), kot bolnic, ki so jemale placebo (2,7 %).
Three metabolites of lasofoxifene were detected in plasma: the direct glucuronide conjugate, the glucuronide of a hydroxylated metabolite, and the methylated catechol.
V plazmi so odkrili tri presnovke lasofoksifena: direktni glukuronidni konjugat, glukuronid hidroksiliranega presnovka in metilirani katehol.
Lasofoxifene clearance may be increased in patients chronically treated with inducers of CYP3A4 and UGTs (eg, phenytoin, carbamazepine, barbiturates and St John's Wort) resulting in reduced steadystate concentrations and may result in reduced efficacy.
Očistek lasofoksifena se lahko poveča pri bolnicah, kronično zdravljenih z induktorji CY3A4 in UGT encimov (npr. fenitoin, karbamazepin, barbiturati, šentjanževka), kar povzroči nižjo koncentracijo v stanju dinamičnega ravnovesja in posledično manjšo učinkovitost zdravila.
In clinical trials, FABLYN-treated women had an increased risk of venous thromboembolic events (deep vein thrombosis and pulmonary embolism) compared to placebo.
V kliničnih preskušanjih je bila pri ženskah, zdravljenih z zdravilom FABLYN, zvečana nevarnost venskih trombemboličnih dogodkov (globoka venska tromboza in pljučna embolija), v primerjavi s tistimi, ki so jemale placebo.
• The other ingredients are lactose anhydrous; microcrystalline cellulose; croscarmellose sodium; silica, colloidal anhydrous; magnesium stearate; sunset yellow FCF aluminium lake (E110); hypromellose; lactose monohydrate; titanium dioxide (E171) and triacetin.
• Pomožne snovi so brezvodna laktoza, mikrokristalna celuloza, premrežen natrijev karmelozat, brezvodni koloidni silicijev dioksid; magnezijev stearat, oranžno FCF (E110), hipromeloza, laktoza monohidrat, titanov dioksid (E171) in triacetin.
In a population pharmacokinetic analysis, no discernible difference in lasofoxifene pharmacokinetics was detected in different racial groups.
Pri populacijski farmakokinetični analizi niso odkrili vidne razlike farmakokinetike lasofoksifena pri različnih rasah.
The pharmacokinetics of lasofoxifene have not been evaluated in a paediatric population.
Farmakokinetike lasofoksifena v otroški populaciji niso preučili.
• Burning sensation, dizziness, numbness, memory impairment, impaired or partial loss of movement of a limb, headache, restless legs syndrome (an irresistible urge to move legs to stop an uncomfortable or odd sensations)
• pekoč občutek, omotica, odrevenelost, spominske motnje, zmanjšana ali delno izgubljena gibljivost katerega od udov, glavobol, sindrom nemirnih nog (nepremagljiva želja, da bi migali z nogami in se s tem rešili nelagodnih ali čudnih občutkov);
Steady-state pharmacokinetics of lasofoxifene are consistent with expectations from its single-dose pharmacokinetics.
Farmakokinetika lasofoksifena je v stanju dinamičnega ravnovesja skladna s pričakovanji na podlagi njegove farmakokinetike enkratnega odmerka.
Your doctor may also advise you to take Calcium and Vitamin D supplements while you are treated with FABLYN if your daily intakes are not considered sufficient.
Če bo zdravnik mnenja, da zaužijete dnevno premalo kalcija in vitamina D, vam bo mogoče svetoval, da med zdravljenjem z zdravilom FABLYN jemljite ustrezna prehranska dopolnila.
Patients with this medical history should have serum triglycerides monitored when taking lasofoxifene.
Pri bolnicah s takšno anamnezo je treba med zdravljenjem z lasofoksifenom nadzorovati nivo serumskih trigliceridov.
In two-year carcinogenicity studies conducted in rats (≥1 mg/kg/day; 7 times systemic exposure following a human dose of 0.5 mg/day based on plasma AUC) an increased incidence of renal tubular adenoma and carcinoma in males and granulosa cell tumours of the ovary in females was noted.
V dveletnih študijah kancerogenosti, ki so jih opravili pri podganah (≥1 mg/kg/dan; 7-krat večja sistemska izpostavljenost kot po odmerku 0,5 mg/dan pri človeku na podlagi plazemske AUC) so opazili večjo pogostnost tubularnega adenoma in karcinoma ledvic pri samcih in granulozocelularnih tumorjev pri samicah.
If you stop taking FABLYN
Če ste prenehali jemati zdravilo FABLYN
New radiographic vertebral fracture in patients without any prevalent fracture at baseline Percentage of patients with new fracture n=1,970
Novi rentgenski vretenčni zlomi pri bolnicah brez prevladujočega zloma v izhodišču Odstotni delež bolnic z novim zlomom n=1.970
Take special care with FABLYN
Bodite posebno pozorni pri uporabi zdravila FABLYN
In all women with a uterus at baseline, histologically benign endometrial polyps were reported in 34 of 2,302 (1.5%) FABLYN-treated women versus 18 of 2,309 (0.8%) placebo-treated women.
Od vseh žensk, ki so na začetku študije imele maternico, so o histološko benignih endometrijskih polipih poročali pri 34 od 2.302 (1.5%) žensk, zdravljenih z zdravilom FABLYN, v primerjavi z 18 od 2.309 (0,8 %) žensk, ki so jemale placebo.
There was no difference between FABLYN- and placebo-treated women in the incidences of endometrial carcinoma and endometrial hyperplasia.
Med ženskami, zdravljenimi z zdravilom FABLYN, in tistimi, ki so jemale placebo, ni bilo razlik glede pogostnosti karcinoma endometrija in endometrijske hiperplazije.
Hot flush occurred in about one in 11 patients and was most commonly reported during the first 6 months of treatment.
11 bolnic, ki so jemale zdravilo FABLYN, in sicer najpogosteje med prvimi 6 meseci zdravljenja.
Do not take FABLYN
Ne uporabljajte zdravila FABLYN
• Infection in the ear, eye, respiratory tract or skin, diarrhea, blood in stools
• okužbe ušes, oči, dihal ali kože, driska, kri v blatu;
Immune system disorders
Bolezni imunskega sistema
Mean international normalized ratio (INR) AUC and maximum value of INR after single-dose warfarin administration with lasofoxifene were approximately 8% and 16% lower, respectively, than after warfarin alone.
Po enkratnem odmerku varfarina z lasofoksifenom je bila srednja vrednost mednarodnega normaliziranega kvocienta (INR) površine pod krivuljo (AUC) manjša za približno 8 %, največja vrednost INR po enkratnem odmerku varfarina z lasofoksifenom pa je bila približno 16 % manjša kot pri samem varfarinu.
Renal insufficiency:
Insuficienca ledvic:
FABLYN film-coated tablets are supplied in PVC blisters with aluminum foil backing or HDPE bottles with polyethylene/aluminum foil lined polypropylene child-resistant closures.
Filmsko obložene tablete FABLYN so na voljo v polivinilkloridnih (PVC) pretisnih omotih z aluminijasto prekrivno folijo ali v plastenkah iz polietilena velike gostote (HDPE) s polipropilenskimi za otroke varnimi zaporkami, prevlečenimi s folijo iz polietilena in aluminija.
SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT
POSEBNO OPOZORILO O SHRANJEVANJU ZDRAVILA ZUNAJ DOSEGA IN
As a consequence of these benign effects, more FABLYN-treated patients had a diagnostic uterine procedure compared to placebo-treated patients in the PEARL trial (see section 5.1).
Zaradi teh benignih učinkov je imelo diagnostične preiskave maternice več bolnic, zdravljenih z zdravilom FABLYN, v primerjavi z bolnicami, ki so v študiji PEARL jemale placebo (glejte poglavje 5.1).
Table 1 lists adverse reactions occurring in the two osteoporosis treatment clinical trials that occurred at an incidence greater than placebo.
V preglednici 1 so navedeni neželeni učinki, ki so se pogosteje kot pri placebu pojavili v dveh kliničnih preskušanjih zdravljenja osteoporoze.
GENERAL CLASSIFICATION FOR SUPPLY Medicinal product subject to medical prescription.
NAČIN IZDAJANJA ZDRAVILA Izdaja zdravila je le na recept.
Safety and efficacy of FABLYN have not been evaluated in patients with severe renal insufficiency; therefore, FABLYN should be used with caution in these patients (see section 4.2 and section 5.2).
Varnosti in učinkovitosti zdravila FABLYN niso ovrednotili pri bolnicah s hudo insuficienco ledvic; zato je treba pri teh bolnicah zdravilo FABLYN uporabljati previdno (glejte poglavje 4.2 in 5.2).
All clinical fractures Percentage of patients with clinical fracture n=2,852
Vsi klinični zlomi Odstotni delež bolnic s kliničnim zlomom n=2.852
HOW TO TAKE FABLYN
KAKO JEMATI ZDRAVILO FABLYN
No dose adjustment is necessary in elderly female patients (see section 5.2).
Pri starejših bolnicah prilagajanje odmerka ni potrebno (glejte poglavje 5.2).
These included, in some subjects, a small excess in the incidence of vaginal bleeding as well as endometrial cystic change viewed on ultrasound and histological benign cystic atrophy (a variant of atrophic endometrium).
Pri nekaterih osebah so ti vključevali tudi nekoliko zvečano pogostnost krvavitve iz nožnice, kot tudi cistično spremembo endometrija, vidno z ultrazvokom, in histološko benigno cistično atrofijo (različica atrofičnega endometrija).
Significantly fewer women treated with FABLYN experienced moderate or severe vertebral fractures (as determined by the Genant scale) compared to women treated with placebo (5.2% placebo-treated women versus 3.3% FABLYN-treated women; p = 0.0006).
Zmerni ali težki vretenčni zlomi (klasificirane po Genantovi lestvici) je dobilo signifikantno manj žensk od tistih, ki so jemale placebo (5,2 % žensk s placebom in 3,3 % žensk, zdravljenih z zdravilom FABLYN; p = 0,0006).
There were 0.48 events/100 patient years in the placebo group and 0.36 events/100 patient years among FABLYN-treated patients (HR = 0.75; 95% CI 0.51, 1.10, p = 0.140).
V skupini s placebom je bilo 0,48 dogodka/100 bolnikov-let in 0,36 dogodka/100 bolnikov-let med bolnicami, zdravljenimi z zdravilom FABLYN (HR = 0,75; 95 % CI 0,51, 1,10 p = 0,140).
FABLYN may be administered any time of day without regard to food or beverage intake.
Zdravilo FABLYN se lahko jemlje ob poljubnem dnevnem času ne glede na uživanje hrane ali pijače.
The programme materials shall be provided via the following means:
Izobraževalni programi bodo dostopni:
Common adverse reactions considered to be related to FABLYN therapy were muscle spasms, hot flush and vaginal discharge.
Pogosti neželeni učinki, za katere menijo, da so bili povezani z zdravljenjem z zdravilom FABLYN, so bili mišični spazmi, vročinski oblivi in izcedek iz nožnice.
• If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet,
• Če katerikoli neželeni učinek postane resen ali če opazite katerikoli neželeni učinek, ki ni omenjen v tem navodilu, obvestite svojega zdravnika ali farmacevta.
FABLYN is only for use in postmenopausal women.
Zdravilo FABLYN se sme uporabljati samo pri ženskah v postmenopavzi.
In addition, an updated RMP should be submitted
Poleg tega je treba posodobljen načrt za obvladovanje tveganja predložiti:
Through 5 years of follow-up, 37 FABLYN-treated women (1.3%, or 2.90 per 1,000 patients years) had a VTE compared to 18 placebo-treated women (0.6%, or 1.41 per 1,000 patients years) and the hazard ratio was 2.06 (95% CI: 1.17, 3.61).
V 5 letih spremljanja bolnic se je VTE pojavila pri 37 ženskah, zdravljenih z zdravilom FABLYN (1,3 % ali 2,90 na 1.000 bolnikov-let ("patient-years")), v primerjavi z 18 ženskami, ki so jemale placebo (0,6 % ali 1,41 na 1.000 bolnikov-let), količnik tveganja (HR) pa je bil 2,06 (95 % interval zaupanja (CI): 1,17, 3,61).
Venous Thromboembolic Events: The most serious adverse reaction related to FABLYN was VTE (deep venous thrombosis, pulmonary embolism, and retinal vein thrombosis).
Venski trombembolični dogodki (VTE-Venous Thromboembolic Event): Najresnejši neželen učinek, povezan z zdravilom FABLYN, je bil VTE (globoka venska tromboza, pljučna embolija in tromboza mrežnične vene).
No case of FABLYN overdose has been reported.
Doslej niso poročali o nobenem primeru zaužitja prevelikega odmerka zdravila FABLYN.
In the corresponding 2-year study in mice (≥2 mg/kg/day; less than systemic exposure following a human dose of 0.5 mg/day based on plasma AUC), there was an increased incidence of adrenal cortical adenoma and carcinoma, interstitial cell tumors of the testis, benign and malignant ovarian tumors and benign uterine glandular polyps.
V ustrezni dveletni študiji pri miših (≥2 mg/kg/dan; manjša sistemska izpostavljenost kot po odmerku 0,5 mg/dan pri človeku na podlagi plazemske AUC) je bila povečana pogostnost adenomov in karcinomov skorje nadledvične žleze, tumorjev intersticijskih celic mod, benignih in malignih tumorjev jajčnikov in benignih endometrialnih žleznih polipov.
What FABLYN looks like and contents of the pack FABLYN tablets are triangular, peach coloured, film-coated tablets marked with “Pfizer” on one side and “OPR 05” on the other.
Tablete FABLYN so trikotne filmsko obložene tablete breskove barve z vtisnjenim napisom “Pfizer” na eni strani in “OPR 05” na drugi strani.
• Dizziness, altered sense of taste, seizures, migraine, weakness of arms or legs, sciatica (pain felt in the lower back, buttock, and/or various parts of the leg and foot; typically on one side of the
• vrtoglavost, spremenjen čut za okus, epileptični napadi, migrena, šibkost zgornjih ali spodnjih udov, išias (bolečina v križu, zadnjici in/ali raznih delih spodnjega uda in stopala; značilno na
The following results of the effects of FABLYN on the endometrium through 5 years of exposure are reported from the PEARL study.
V študiji PEARL so poročali o naslednjih rezultatih glede učinkov zdravila FABLYN na endometrij v obdobju petletne izpostavljenosti.
Medicinal product subject to medical prescription.
Izdaja zdravila je le na recept.
Placebo-treated women had a 1.9% incidence in cystic change over 3 years, whereas the FABLYNtreated women had a 20.4% incidence.
Pogostnost cističnih sprememb v obdobju 3 let, je bila pri ženskah, ki so jemale placebo,1,9odstotna, pri ženskah zdravljenih z zdravilom FABLYN pa 20,4-odstotna.
Less than 2% of the administered dose was recovered in the urine as unchanged lasofoxifene.
V urinu so, v obliki nespremenjenega lasofoksifena, prestregli manj kot 2% danega odmera.
QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains lasofoxifene tartrate, equivalent to 500 micrograms lasofoxifene.
KAKOVOSTNA IN KOLIČINSKA SESTAVA Ena filmsko obložena tableta vsebuje lasofoksifenijev tartrat, kar ustreza 500 mikrogramom lasofoksifena.
-Non-vertebral fractures
-Nevretenčni zlomi
FABLYN has not been studied in women with a prior history of breast cancer.
Rabe zdravila FABLYN niso preučili pri ženskah z rakom dojke v anamnezi.
Important information about some of the ingredients of FABLYN FABLYN contains lactose.
Pomembne informacije o nekaterih sestavinah zdravila FABLYN
• Change in appetite
• spremembe teka;
What FABLYN contains
Kaj vsebuje zdravilo FABLYN
MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH
DOVOLJENJA ZA IZDELAVO ZDRAVILA, ODGOVOREN ZA SPROŠČANJE
• Very common: affects more than 1 user in 10
• Zelo pogosti: pojavijo se pri več kot 1 od 10 bolnikov
New radiographic vertebral fractures Percentage of patients with new fracture n=2,748
Novi rentgenski vretenčni zlomi Odstotni delež bolnic z novim zlomom n=2.748
A less serious event, superficial thrombophlebitis, also has been reported more frequently with FABLYN compared to placebo.
Pri zdravilu FABLYN so v primerjavi s placebom pogosteje poročali tudi o površinskem tromboflebitisu, ki je manj resen dogodek.
Vaginal bleeding was reported in 74 (2.6%) FABLYN-treated women versus 37 (1.3%) placebo-treated women.
O krvavitvah iz nožnice so poročali pri 74 (2,6 %) ženskah, zdravljenih z zdravilom FABLYN, in pri 37
However, in clinical practice, these benign findings do not warrant further evaluation in women with no vaginal bleeding (in accordance with guidelines for postmenopausal women), as the risks of diagnostic uterine procedures in asymptomatic women outweigh any benefits.
Vendar pa v klinični praksi te benigne spremembe, ne zahtevajo nadaljnjih diagnostičnih preiskav, če pri ženskah ni prisotna krvavitev iz nožnice (v skladu s smernicami za ženske v postmenopavzi).
• if you currently have or previously had blood clots, for example in your veins, lungs or eyes
• če imate trenutno ali ste kdaj imeli krvne strdke, na primer v venah, pljučih ali očeh (globoko vensko trombozo, pljučno embolijo ali trombozo mrežnične vene);
Each film-coated tablet contains lasofoxifene tartrate, equivalent to 500 micrograms of lasofoxifene.
Ena filmsko obložena tableta vsebuje lasofoksifenijev tartrat, kar ustreza 500 mikrogramov lasofoksifena.
Film-coated tablet.
filmsko obložena tableta
FABLYN can be taken with or without food and drink.
Zdravilo FABLYN lahko jemljete skupaj s hrano in pijačo, lahko pa tudi brez njiju.
• Excessive sweating
• čezmerno potenje.
Active or past history of venous thromboembolic events, including deep vein thrombosis, pulmonary embolism and retinal vein thrombosis.
Aktivna venska trombembolična bolezen ali venski trombembolični dogodki v anamnezi, vključno z globoko vensko trombozo, pljučno embolijo in trombozo mrežnične vene.
Non-vertebral fractures Percentage of patients with non-vertebral fracture n=2,852
Nevretenčni zlomi Odstotni delež bolnic z nevretenčnim zlomom n=2.852
FABLYN must not be taken by women of childbearing potential (see section 4.3).
Ženske v rodni dobi zdravila FABLYN ne smejo jemati (glejte poglavje 4.3).
-Bone mineral density
Mineralna gostota kosti
No dose adjustment for FABLYN is necessary in elderly patients.
Pri starejših bolnicah prilagajanje odmerka zdravila FABLYN ni potrebno.
• Hot flush
• vročinski obliv;
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).
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).
Triacetin
Čet
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).
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).
• Common: affects 1 to 10 users in 100
• Pogosti: pojavijo se pri 1 do 10 bolnikih od 100 bolnikov
• Rare: affects 1 to 10 users in 10,000
• Redki: pojavijo se pri 1 do 10 bolnikih od 10.000 bolnikov
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).
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).
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).
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).
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.
Ker se zdravilo FABLYN uporablja pri ženskah v postmenopavzi, ni indicirano pri otrocih in mladostnikih, mlajših od 18 let.
Uncommon: Micturition urgency, nocturia, pollakiuria, urethral disorder, urinary incontinence Rare:
Občasni: nenadna močna želja po uriniranju, nikturija, polakisurija, obolenje uretre, urinska inkontinenca
• Dry eye, hair loss, skin rash, night sweats, itching, feeling hot, weight gain
• suhe oči, izpadanje las, kožni izpuščaj, nočno potenje, srbenje, občutek vročine, porast telesne mase;
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).
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).
NAME OF THE MEDICINAL PRODUCT FABLYN 500 microgram film-coated tablets.
IME ZDRAVILA FABLYN 500 mikrogramov filmsko obložene tablete
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION FABLYN 500 microgram film-coated tablets lasofoxifene
IME ZDRAVILA IN POT(I) UPORABE FABLYN 500 mikrogramov filmsko obložene tablete lasofoksifen peroralna uporaba
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS BOTTLE LABEL
PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
photosensitivity reaction, pruritus generalized, rash maculo-papular, rash pruritic,
preobčutljivostna reakcija na svetlobo, generalizirani pruritus, makulopapularen izpuščaj,
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.
Varnosti in učinkovitosti lasofoksifena niso ovrednotili pri bolnicah s hudo insuficienco ledvic, zato je treba pri teh bolnicah zdravilo FABLYN uporabljati previdno.
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).
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).
No dose adjustment is necessary in patients with mild or moderate renal insufficiency (see section 5.2).
Pri bolnicah z blago ali zmerno insuficienco ledvic prilagajanje odmerka ni potrebno (glejte poglavje 5.2).
No dose adjustment for FABLYN is necessary for patients with mild or moderate renal insufficiency (see section 4.4).
Pri bolnicah z blago ali zmerno insuficienco ledvic ni potrebno prilagajanje odmerka zdravila FABLYN (glejte poglavje 4.4).