FrancophonIA/ELRC3.0 huggingface dataset:
English: Act.: {Y}________GBq/vial Cal.: {DD/MM/AAAA} (12h CET)
Slovenian: : {Y}________GBq/vial Kal.
English: EU/1/05/322/002
Slovenian: ŠTEVILKA (ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/05/322/002
English: The pharmacodynamic properties of Yttrium (90Y)-labelled medicinal products prepared by radiolabelling with Yttriga, prior to administration, will be dependent on the nature of the medicinal product to be radiolabelled.
Slovenian: Farmakodinamične lastnosti z itrijem (90Y) označenega zdravila, pripravljenega z radioaktivnim označevanjem z radiofarmacevtskim predhodnikom Yttriga pred dajanjem, bodo odvisne od vrste zdravila,
English: EU/1/05/322/001
Slovenian: ŠTEVILKA (ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/05/322/001
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Yttriga radiopharmaceutical precursor, solution.
Slovenian: IME ZDRAVILA IN POT(I) UPORABE Yttriga radiofarmacevtski predhodnik, raztopina itrijev (90Y) klorid
English: Lungs
Slovenian: pljuča
English: 7.23 E-01 1.09 E+00 2.53 E+00 3.62 E+00 7.23 E+00 2.17 E+01
Slovenian: Novorojenč ki (5 kg) nadledvična žleza 7,23 E-01 1,09 E+00 2,53 E+00 3,62 E+00 7,23 E+00 2,17 E+01 kri
English: HOW TO USE YTTRIGA
Slovenian: Način uporabe
English: 1. clinically relevant literature references on the prevention and management of IFIS;
Slovenian: 1. klinično pomembne reference v literaturi o preprečevanju in obravnavi IFIS;
English: The MAH shall ensure that all eye surgeons in the EU Countries in which silodosin will be marketed are provided with the following information:
Slovenian: Imetnik dovoljenja za promet z zdravilom bo zagotovil, da prejmejo vsi kirurgi v državah EU, v katerih se bo silodozin prodajal, naslednje informacije:
English: 3. recommendation to surgeons and ophthalmic teams: discontinuing treatment with α1adrenoceptor antagonists 2 weeks prior to cataract surgery has been recommended, but the benefit and duration of stopping therapy prior to cataract surgery has not yet been established.
Slovenian: 3. priporočila za kirurge in oftalmične ekipe: priporoča se prekinitev zdravljenja z antagonisti α1-adrenergičnih receptorjev 2 tedna pred operacijo sive mrene, vendar koristi in trajanja ustavitve zdravljenja pred operacijo sive mrene niso ugotavljali.
English: • an educational program on the prevention and management of IFIS (at launch and after launch); covering the following topics:
Slovenian: • izobraževalni program o preprečevanju in obravnavi IFIS (ob začetku prodaje in po njem), ki zajema naslednje točke:
English: 2. pre-operative assessment: eye surgeons and ophthalmic teams should establish whether patients scheduled for cataract surgery are being or have been treated with silodosin in order to ensure that appropriate measures are in place to manage IFIS during surgery.
Slovenian: 2. predoperativna ocena: očesni kirurgi in oftalmološke skupine morajo med pripravo na operacijo preveriti, ali se bolniki, ki so predvideni za operacijo sive mrene, zdravijo ali so se zdravili s silodozinom, da bi lahko pripravili vse potrebno za obvladovanje IFIS med operacijo.
English: • the Direct Healthcare Professional Communication (DHPC) on the association of Silodosin with Intraoperative Floppy Iris Syndrome and the two literature references mentioned in the text of the communication (at launch);
Slovenian: • Neposredno obvestilo za zdravstvene delavce (DHPC) o povezavi zdravilne učinkovine silodozin z medoperacijskim sindromom ohlapne šarenice in dve referenci v literaturi, omenjeni v besedilu obvestila (ob začetku prodaje);
English: The Member States should ensure that all conditions or restrictions with regard to the safe and effective use of the medicinal product described below are implemented:
Slovenian: Države članice morajo zagotoviti, da se izvajajo vsi spodaj opisani pogoji ali omejitve v zvezi z varno in učinkovito uporabo zdravila:
English: CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF MEDICINAL PRODUCT TO BE IMPLEMENTED BY THE MEMBER STATES
Slovenian: POGOJI ALI OMEJITVE V ZVEZI Z VARNO IN UČINKOVITO UPORABO ZDRAVILA, KI JIH MORAJO IZVAJATI DRŽAVE ČLANICE
English: • a flow-chart describing the management of patients for which cataract surgery is scheduled (at launch and after launch);
Slovenian: • diagram, ki opisuje obravnavo bolnikov, pri katerih je načrtovana operacija sive mrene (ob začetku prodaje in po njem);
English: Date of first authorisation: 15 January 2015
Slovenian: Datum prve odobritve: 15. januar 2015
English: Elderly (>65 years old)
Slovenian: Starejši (>65 let)
English: The magnitude of effect was similar in all three trials.
Slovenian: Velikost učinka je bila v vseh treh preskušanjih podobna.
English: However, all exposures were far below the intended human exposure.
Slovenian: Vendar pa so bile vse izpostavljenosti veliko pod nameravano izpostavljenostjo ljudi.
English: Risk management plan (RMP)
Slovenian: • Načrt za obvladovanje tveganj (RMP)
English: The apparent volume of distribution is 448 l.
Slovenian: Navidezni porazdelitveni volumen je 448 l.
English: “Improvement” was defined as a reduction in the severity score of 1 or more.
Slovenian: „Izboljšanje“ je bilo opredeljeno kot zmanjšanje ocene resnosti za 1 ali več.
English: You should therefore speak to your doctor immediately.
Slovenian: Takoj se posvetujte z zdravnikom.
English: Your doctor will explain the effects of stopping treatment and will also discuss other possibilities for treatment with you.
Slovenian: Vaš zdravnik vam bo razložil učinke prenehanja zdravljenja in se z vami pogovoril tudi o drugih možnostih zdravljenja za vas.
English: Kingsfordweg 151 1043GR Amsterdam Netherlands
Slovenian: Kingsfordweg 151 1043GR Amsterdam Nizozemska
English: Do not give this medicine to children or adolescents.
Slovenian: Otroci in mladostniki Tega zdravila ne dajajte otrokom ali mladostnicam.
English: The potential risk in humans is unknown.
Slovenian: Možno tveganje za ljudi ni znano.
English: - If you have had a stroke (a cerebrovascular accident), or if your doctor has told you that you are at high risk of having one.
Slovenian: - Če ste imeli možgansko kap (cerebrovaskularni inzult) ali če vam je zdravnik povedal, da je pri vas veliko tveganje, da jo boste imeli.
English: In the F0 maternal generation, a significant prolonged gestation was observed.
Slovenian: V F0 maternalni generaciji so opazili močno podaljšano gestacijo.
English: Physiological responses (objective measures)
Slovenian: Fiziološki odzivi (objektivna merila)
English: Symptoms (subjective measures)
Slovenian: Simptomi (subjektivna merila)
English: The most frequently reported adverse reactions are hot flushes (7.5%).
Slovenian: Neželeni učinek, o katerem so najpogosteje poročali, so bili vročinski oblivi (7,5%).
English: “Relief” was defined as no or only mild symptoms at week 12.
Slovenian: „Olajšanje je bilo opredeljeno kot brez simptomov ali le z blagimi simptomi v 12. tednu.
English: The apparent terminal half-life of ospemifene in post-menopausal women is approximately 25 hours.
Slovenian: Navidezni končni razpolovni čas ospemifena pri ženskah po menopavzi je približno 25 ur.
English: Ospemifene should only be continued as long as the benefit outweighs the risk.
Slovenian: Zdravljenje z ospemifenom se sme nadaljevati le tako dolgo, dokler so koristi večje od tveganj.
English: A double dose should not be taken in the same day.
Slovenian: Na isti dan bolnica ne sme vzeti dvojnega odmerka.
English: Ospemifene (OSP) improved post-menopausal physiologic changes.
Slovenian: Ospemifen (OSP) je izboljšal fiziološke spremembe po menopavzi.
English: At these check-ups, discuss with your doctor the benefits and risks of continuing with Senshio.
Slovenian: Na teh pregledih se z zdravnikom pogovorite o koristih in tveganjih nadaljevanja zdravljenja z zdravilom Senshio.
English: The risk of cerebrovascular events is possibly increased with other SERMs.
Slovenian: Tveganja za cerebrovaskularne dogodke se morda poveča z drugimi SERM.
English: It is caused by a lowering in the levels of the female hormone oestrogen in your body.
Slovenian: Povzročajo jo znižane ravni ženskega hormona estrogena v telesu.
English: Table 2 shows the percentage of subjects who reported a change in their MBS at week 12.
Slovenian: V preglednici 2 je prikazan odstotek oseb, ki so poročale o spremembi MBS v 12. tednu.
English: Fertility studies were not conducted.
Slovenian: Študij plodnosti niso izvajali.
English: It is recommended that any additional pathology be investigated and treated appropriately before starting ospemifene.
Slovenian: Vsako dodatno patologijo je priporočljivo raziskati in ustrezno zdraviti pred uvedbo ospemifena.
English: - If you have had breast cancer.
Slovenian: - Če ste kadar koli imeli raka dojke.
English: - An allergic reaction.
Slovenian: (hipertrofija endometrija) - alergijska reakcija.
English: - Any of your close relatives has ever had a blood clot in the leg, lung or other organ.
Slovenian: - Kateri od bližnjih sorodnikov je kadar koli imel krvni strdek v nogah, pljučih ali drugem organu.
English: The biological activity profile in humans is predominantly due to the parent compound.
Slovenian: Profil biološke aktivnosti pri ljudeh je v glavnem posledica izhodiščne spojine.
English: In some asymptomatic patients, hot flushes may occur upon beginning therapy.
Slovenian: Pri nekaterih asimptomatskih bolnicah se lahko vročinski oblivi pojavijo po začetku zdravljenja.
English: In the event of overdose, general supportive measures should be initiated based on the patient's signs and symptoms.
Slovenian: Ob prevelikem odmerjanju se uvedejo podporni ukrepi na podlagi znakov in simptomov bolnice.
English: This improvement in objective measures (superficial and parabasal cells and pH) were sustained in ospemifene treated women in a long-term study of up to 52 weeks.
Slovenian: To izboljšanje v objektivnih merilih (površinske in parabazalne celice in pH) so se pri ženskah, zdravljenih z ospemifenom, ohranile v dolgoročni študiji do 52 tednov.
English: There were no discernible differences in ospemifene plasma concentrations among these groups; however, the influence of race cannot be conclusively determined.
Slovenian: Med temi skupinami niso opazili vidnih razlik v koncentracijah ospemifena v plazmi, vendar pa vpliva rase ni mogoče dokončno ugotoviti.
English: Patients with signs or symptoms of endometrial hyperplasia; safety in this patient group has not been studied.
Slovenian: Bolnice z znaki ali simptomi hiperplazije endometrija; varnosti v tej skupini bolnic niso ustrezno preučili.
English: Senshio must be taken every day for as long as your doctor tells you to.
Slovenian: Zdravilo Senshio jemljite vsak dan, toliko časa kot vam naroči zdravnik.
English: Senshio should be taken with food.
Slovenian: Zdravilo Senshio je treba vzeti s hrano.
English: Manufacturing Packaging Farmaca (MPF) B.V. Appelhof 13
Slovenian: Manufacturing Packaging Farmaca (MPF) B.V.
English: The European Medicines Agency has waived the obligation to submit the results of studies with ospemifene in all subsets of the paediatric population in VVA (see section 4.2 for information on paediatric use).
Slovenian: Evropska agencija za zdravila je odstopila od zahteve za predložitev rezultatov študij z ospemifenom za vse podskupine pediatrične populacije z VVA (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
English: Improvement
Slovenian: Izboljšanje
English: Ganciclovir used to treat infections caused by a virus called cytomegalovirus.
Slovenian: o Ganciklovir, ki se uporablja za zdravljenje okužb, ki jih povzroči virus, imenovan citomegalovirus.
English: The requirements for submission of PSURs for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Slovenian: • Redno posodobljena poročila o varnosti zdravila (PSUR-i) Zahteve glede predložitve PSUR za to zdravilo so določene v seznamu referenčnih datumov EU (seznamu EURD), opredeljenem v členu 107c(7) Direktive 2001/83/ES, in vseh kasnejših posodobitvah, objavljenih na evropskem spletnem portalu o zdravilih.
English: PVC/PVdC-Aluminium blister.
Slovenian: PVC/PVdC/aluminijev pretisni omot.
English: Less than 0.2% of the ospemifene dose was excreted unchanged in urine.
Slovenian: Manj kot 0,2% odmerka ospemifena se je nespremenjenega izločilo v urinu.
English: Fluconazole (an oral medicine used to treat fungal infections) as this may increase the amount of ospemifene in your blood.
Slovenian: • Flukonazol (peroralno zdravilo, ki se uporablja za zdravljenje glivičnih okužb), saj lahko to poveča količino ospemifena v vaši krvi.
English: The marketing authorisation holder (MAH) shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the marketing authorisation and any agreed subsequent updates of the RMP.
Slovenian: Imetnik dovoljenja za promet z zdravilom (MAH) bo izvedel zahtevane farmakovigilančne aktivnosti in ukrepe, podrobno opisane v sprejetem RMP, predloženem v modulu 1.8.2 dovoljenja za promet z zdravilom, in vseh nadaljnjih sprejetih posodobitvah RMP.
English: The risk of VTE is temporarily increased with prolonged immobilisation, major trauma or major surgery.
Slovenian: Tveganje za VTE se začasno poveča s podaljšano imobilizacijo, hujšo poškodbo ali večji kirurški poseg.
English: Patients should be advised to contact their doctors immediately when they experience a potential thromboembolic symptom (e.g. painful swelling of a leg, sudden pain in the chest, dyspnoea).
Slovenian: Bolnicam je treba svetovati, naj se takoj posvetujejo z zdravnikom, če doživijo možne trombembolične simptome (npr. boleča oteklina noge, nenadna bolečina v prsnem košu, dispneja).
English: There is therefore no reason to expect that strong CYP3A4 inhibitors would cause a clinically meaningful change in ospemifene exposure.
Slovenian: Zato ni razloga pričakovati, da bi močni zaviralci CYP3A4 povzročili klinično pomembno spremembo izpostavljenosti ospemifenu.
English: Pharmacokinetic differences due to race have been studied in 1,091 postmenopausal women, including 93.1% White, 3.9% Black, 1.8% Asian and 1.1% other in VVA trials.
Slovenian: Farmakokinetične razlike zaradi rase so preučili pri 1.091 ženskah po menopavzi, vključno s 93,1% belk, 3,9% črnk, 1,8% Azijk in 1,1% pripadnic drugih ras v preskušanjih VVA.
English: Ospemifene and 4-hydroxyospemifene are highly (both >99%) bound to serum proteins.
Slovenian: Ospemifen in 4-hidroksiospemifen se močno (oba > 99%) vežeta na serumske beljakovine.
English: - If you are suffering from any gynaecological illness other than vulvar and vaginal atrophy.
Slovenian: - Če trpite zaradi kakršne koli druge ginekološke bolezni poleg atrofije vulve in vagine.
English: There is no specific antidote for ospemifene.
Slovenian: Specifičnega antidota za ospemifen ni.
English: Substantial improvement 60 mg OSP Placebo 60 mg OSP Placebo 60 mg OSP Placebo
Slovenian: Bistveno izboljšanje 60 mg OSP Placebo 60 mg OSP Placebo 60 mg OSP Placebo
English: Due to its lipophilic nature and absorption characteristics, an interaction between ospemifene and medicinal products like orlistat, cannot be ruled out.
Slovenian: Zaradi lipofilnosti in absorpcijskih značilnosti medsebojnega delovanja med ospemifenom in zdravili, kot je orlistat, ni mogoče izključiti.
English: In contrast, abnormal, not clinically significant, findings on mammography increased in the placebo population from 6.5% to 8.3%.
Slovenian: Nasprotno pa so se nenormalni, klinično nepomembni izsledki na mamografiji v populaciji s placebom povečali s 6,5% do 8,3%.
English: - You are seriously overweight (BMI >30 kg/m2).
Slovenian: - Ste močno predebeli (indeks telesne mase (ITM) > 30 kg/m2).
English: A low fat meal resulted in approximately a two-fold increase in exposure of ospemifene and a high fat meal resulted in approximately a three-fold increase in exposure of ospemifene in two food effect studies with tablet formulations different from the commercial formulation.
Slovenian: Pri obroku z nizko vsebnostjo maščob se je izpostavljenost ospemifenu povečala za približno dvakrat, obrok z visoko vsebnostjo maščob pa je povzročil približno trikratno zvišanje izpostavljenosti ospemifenu v dveh študijah učinka hrane s formulacijami tablet, ki so se razlikovale od komercialne formulacije.
English: The tablets should be swallowed whole with food.
Slovenian: Tableto pogoltnite celo s hrano.
English: Your doctor may consider stopping treatment with Senshio while you are taking fluconazole.
Slovenian: Vaš zdravnik se lahko odloči za prenehanje zdravljenja z zdravilom Senshio, medtem ko uporabljate flukonazol.
English: Ospemifene may increase the incidence of hot flushes and is not effective in reducing hot flushes associated with oestrogen deficiency.
Slovenian: Vročinski oblivi Ospemifen lahko poveča incidenco vročinskih oblivov in ni učinkovito pri zmanjševanju vročinskih oblivov, povezanih s pomanjkanjem estrogena.
English: Ospemifene has not been studied in patients with severe hepatic impairment, therefore Senshio is not recommended for use in such patients (see section 5.2).
Slovenian: Ospemifena niso preučili pri bolnicah s hudo jetrno okvaro, zato se uporaba zdravila Senshio pri teh bolnicah ne priporoča (glejte poglavje 5.2).
English: EU/1/14/978/001 7 film-coated tablets EU/1/14/978/002 28 film-coated tablets EU/1/14/978/003 84 film-coated tablets
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/14/978/001 7 filmsko obloženih tablet EU/1/14/978/002 28 filmsko obloženih tablet EU/1/14/978/003 84 filmsko obloženih tablet
English: Orlistat sometimes used to treat obesity.
Slovenian: o Orlistat, ki se včasih uporablja za zdravljenje debelosti.
English: This is because there are no data on the use of Senshio in pregnant or pre-menopausal women or those who are breast-feeding.
Slovenian: Vzrok je v tem, ker ni podatkov o uporabi zdravila Senshio pri nosečnicah, ženskah pred menopavzo ali ženskah, ki dojijo.
English: This effect was likely due to the anti-oestrogenic effect of ospemifene in this target tissue, which was attenuating the physiological thymic involution (atrophy) process induced by oestrogens starting during puberty.
Slovenian: Ta učinek je bil verjetno posledica antiestrogenskega učinka ospemifena v tem ciljnem tkivu, kar je oslabilo proces fiziološke involucije (atrofije) timusa, ki ga je povzročil estrogen z začetkom med puberteto.
English: Senshio works in a similar way to some of the helpful effects of oestrogen, helping to improve these symptoms and the underlying causes of vulvar and vaginal atrophy.
Slovenian: Zdravilo Senshio deluje na podoben način kot nekateri koristni učinki estrogena in pomaga pri izboljšanju teh simptomov in vzrokov za atrofijo vulve in vagine.
English: In repeat dose toxicity studies in mouse, rat, dog and the cynomolgus monkey main target organs of toxicity were the ovary, uterus and the liver.
Slovenian: V študijah toksičnosti pri ponavljajočih odmerkih pri miših, podganah, psih in opicah cynomolgus so bili glavni ciljni organi toksičnosti jajčniki, maternica in jetra.
English: Percentage of patients with improvement, relief or substantial improvement of MBS after 12 weeks on ospemifene vs. placebo (ITT, LOCF)
Slovenian: Odstotek bolnic z izboljšanjem, olajšanjem ali bistvenim izboljšanjem MBS po 12. tednu jemanja ospemifena v primerjavi s placebom (ITT, LOCF)
English: Therefore, ospemifene may increase concentrations of medicinal products which are substrates of OCT1 (e.g. metformin, acyclovir, ganciclovir and oxaliplatin).
Slovenian: Zato lahko ospemifen poveča koncentracije zdravil, ki so substrati OCT1 (npr. metformin, aciklovir, ganciklovir in oksaliplatin).
English: Ospemifene belongs to a group of medicines that do not contain hormones called Selective Estrogen Receptor Modulators (SERMs).
Slovenian: Ospemifen sodi v skupino zdravil, ki ne vsebujejo hormonov, imenovanih selektivni modulatorji estrogenskih receptorjev (SERM-selective estrogen receptor modulators).
English: The recommended dose is one 60 mg tablet once daily with food taken at the same time each day.
Slovenian: Priporočeni odmerek je ena 60 mg tableta enkrat na dan s hrano, vsak dan ob istem času.
English: In post-menopausal women who received ospemifene treatment up to 1 year, benign endometrial polyps were reported in 0.4% compared to 0.2% in women who received placebo treatment.
Slovenian: Pri ženskah po menopavzi, ki so se z ospemifenom zdravile do 1 leto, so pri 0,4% poročali o benignih polipih endometrija v primerjavi z 0,2% žensk, ki so prejemale placebo.
English: Generally recognised risk factors for VTE include advanced age, a family history, severe obesity (BMI>30 kg/m2) and systemic lupus erythematosus (SLE).
Slovenian: Na splošno pripoznan dejavniki tveganja za VTE vključujejo starost, družinsko anamnezo, hudo debelost (ITM > 30 kg/m2) in sistemski eritematozni lupus (SLE, systemic lupus erythematosus).
English: You will not benefit from the effects of Senshio if you stop using it without talking to your doctor.
Slovenian: Koristi od učinkov zdravila Senshio ne boste imeli, če ga boste prenehali jemati, ne da bi se prej pogovorili z zdravnikom.
English: Overall, these findings are characteristic for an induction of CYP isoenzymes and are regarded as adaptive responses without any histopathological signs of liver injury.
Slovenian: Ti izsledki so na splošno značilno za indukcijo izoencimov CYP in se obravnavajo kot odziv zaradi prilagoditve brez kakršnih koli histopatoloških znakov poškodbe jeter.
English: If bleeding or spotting occurs on therapy, or continues after treatment has been discontinued, this should always be investigated, which may include an endometrial biopsy to exclude endometrial malignancy.
Slovenian: Če pride do pojava krvavitev ali krvavkastega izcedka med zdravljenjem oziroma se pojav nadaljuje po prekinitvi zdravljenja, je treba to vedno preiskati, morda tudi z biopsijo endometrija, da se izključi malignost na endometriju.
English: - If you have excessive thickening of the womb lining such as endometrial hyperplasia.
Slovenian: - če imate pretirano odebeljeno maternično sluznico, kot je hiperplazija endometrija.
English: In the two 12 weeks studies (trials 1 and 2), 739 patients received ospemifene and 724 patients received placebo.
Slovenian: V dveh 12-tedenskih študijah (preskušanji 1 in 2) je 739 bolnic prejemalo ospemifen in 724 bolnic je prejemalo placebo.
English: All patients received non-hormonal vaginal lubricant for use as needed; therefore, the effects on efficacy endpoints in the ospemifene treatment group were in addition to those achieved with lubricant use alone.
Slovenian: Vsi bolnice so prejemale nehormonski vaginalni lubrikant za uporabo po potrebi, zato je bil učinek na opazovani dogodek učinkovitosti v skupini, zdravljeni z ospemifenom, ocenjen dodatno k učinku, doseženemu s samim lubrikantom.
English: There was a single subject (0.3%) who developed endometrial hyperplasia in the ospemifene group (simple hyperplasia without atypia) 88 days after the last dose of study drug.
Slovenian: Pri eni sami osebi (0,3%) se je razvila hiperplazija endometrija v skupini z ospemifenom (enostavna hiperplazija brez atipije) 88 dni po zadnjem odmerku zdravila v študiji.
English: A clinical monitoring of a decrease in the efficacy of ospemifene should be made.
Slovenian: Potrebno je klinično spremljanje zmanjšane učinkovitosti ospemifena.
English: No subjects in either group developed endometrial cancer or breast cancer during the trials.
Slovenian: Pri nobeni osebi v nobeni skupini se ni med preskušanji razvil rak endometrija ali rak dojke.
English: Any of the following medicines, which may lead to a reduced effect of Senshio: Rifampicin and rifabutin commonly used to treat tuberculosis.
Slovenian: • Katero koli od naslednjih zdravil, ki lahko oslabijo učinek zdravila Senshio: o Rifampicin in rifabutin, ki se pogosto uporabljata za zdravljenje tuberkuloze.