FrancophonIA/ELRC3.0 huggingface dataset:
English: The safety of dexmedetomidine has not been established in males intended for breeding.
Slovenian: Pri ciljnih vrstah ni dokazana varnost deksemedetomidina v obdobju brejosti in laktacije.
English: B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Veterinary medicinal product subject to prescription.
Slovenian: B POGOJI DOVOLJENJA ZA PROMET Z ZDRAVILOM TER OMEJITVE GLEDE OSKRBE IN UPORABE
English: One ml contains 0.1 mg dexmedetomidine hydrochloride equivalent to 0.08 mg dexmedetomidine.
Slovenian: 1 ml vsebuje 0,1 mg deksmedetomidinijevega klorida, ki ustreza 0,08 mg deksmedetomidina
English: Dexmedetomidine 500 micrograms/m2
Slovenian: Deksmedetomidín 500 mikrogramov/m2
English: MARKETING AUTHORISATION NUMBER(S) EU/2/02/033/003
Slovenian: ŠTEVILKA(E) V DOVOLJENJ(A) ZA PROMET EU/2/02/033/003
English: The dosage for cats is 40 micrograms dexmedetomidine hydrochloride/kg bw equal to a dose volume 0.08 ml Dexdomitor/kg bw when used for non-invasive, mildly to moderately painful procedures requiring restraint, sedation and analgesia.
Slovenian: Odmerek za mačke je 40 mikrogramov deksmedetomidinijevega klorida/kg telesne teže, kar ustreza prostorninskemu odmerku 0,08 ml Dexdomitorja/kg telesne teže pri uporabi za neinvazivne, blago do zmerno boleče postopke in preglede mačk, pri katerih so potrebni mirovanje, sedacija in analgezija.
English: One ml contains 0.5 mg dexmedetomidine hydrochloride equivalent to 0.42 mg dexmedetomidine.
Slovenian: 1 ml vsebuje 0,5 mg deksmedetomidinijevega klorida, ki ustreza 0,42 mg deksmedetomidina
English: Dexmedetomidine also induces a number of other α2adrenoceptor mediated effects, which include piloerection, depression of motor and secretory functions of the gastrointestinal tract, diuresis and hyperglycaemia.
Slovenian: Mednje sodijo piloerekcija, upadanje motoričnih in sekretornih funkcij prebavil, diureza in hiperglikemija.
English: PACKAGE LEAFLET DEXDOMITOR 0.1 mg/ml solution for injection
Slovenian: NAVODILO ZA UPORABO DEXDOMITOR 0,1 mg/ml raztopina za injiciranje
English: The dosage for cats is 40 micrograms dexmedetomidine hydrochloride/ kg bw equal to a dose volume 0.4 ml Dexdomitor/ kg bw when used for non-invasive, mildly to moderately painful procedures requiring restraint, sedation and analgesia.
Slovenian: Odmerek za mačke je 40 mikrogramov deksmedetomidinijevega klorida/kg telesne teže, kar ustreza prostorninskemu odmerku 0,4 ml Dexdomitorja/kg telesne teže pri uporabi za neinvazivne, blago do zmerno boleče postopke in preglede mačk, pri katerih so potrebni mirovanje, sedacija in analgezija.
English: 0.5 mg dexmedetomidine hydrochloride equivalent to 0.42 mg dexmedetomidine
Slovenian: 0,5 mg deksmedetomidinijevega klorida, ki ustreza 0,42 mg deksmedetomidina
English: PACKAGE LEAFLET DEXDOMITOR 0.5 mg/ml solution for injection
Slovenian: NAVODILO ZA UPORABO DEXDOMITOR 0,5 mg/ml raztopina za injiciranje
English: When dexmedetomidine is used as a premedicant in dogs bradypnoea, tachypnoea and vomiting may occur.
Slovenian: Pri uporabi deksmedetomidina za pripravo na kirurške posege pri psih lahko pride do bradipneje, tahipneje in bruhanja.
English: ROUTE(S) OF ADMINISTRATION Dogs: intravenous or intramuscular use Cats: intramuscular use
Slovenian: POT(I) UPORABE ZDRAVILA Psi: intravenska in intramuskularna uporaba Mačke: intramuskularna uporaba
English: The dose volume of atipamezole at the concentration of 5 mg/ml equals one-half the volume of Dexdomitor that was given to the cat.
Slovenian: Volumen odmerka atipamezola v koncentraciji 5 mg/ml je enak eni polovici volumna odmerka Dexdomitorja, ki je bil dan mački.
English: 0.1 mg dexmedetomidine hydrochloride equivalent to 0.08 mg dexmedetomidine
Slovenian: 0,1 mg deksmedetomidinijevega klorida, ki ustreza 0,08 mg deksmedetomidina
English: DOGS: In cases of overdosage, or if the effects of dexmedetomidine become potentially life-threatening, the appropriate dose of atipamezole is 10 times the initial dose of dexmedetomidine (micrograms/ kg bw or micrograms/ square meter body surface area).
Slovenian: Psi: V primeru prevelikega odmerjanja, ali če postanejo učinki deksmedetomidina potencialno nevarni za življenje, uporabite odmerek atipamezola, 10-krat večji od prvotnega odmerka deksmedetomidina (v mikrogramih/kg telesne teže ali mikrogramih/kvadratni meter telesne površine).
English: Dogs: In cases of overdosage, or if the effects of dexmedetomidine become potentially life-threatening, the appropriate dose of atipamezole is 10 times the initial dose of dexmedetomidine (micrograms/ kg bw or micrograms/ square meter body surface area).
Slovenian: PSI: V primeru prevelikega odmerjanja, ali če postanejo učinki deksmedetomidina potencialno nevarni za življenje, uporabite odmerek atipamezola, 10-krat večji od prvotnega odmerka deksmedetomidina (v mikrogramih/kg telesne teže ali mikrogramih/kvadratni meter telesne površine).
English: Methyl parahydroxybenzoate (E 218) 2.0 mg/ml Propyl parahydroxybenzoate (E 216) 0.2 mg/ml
Slovenian: 2,0 mg/ml Propilparahidroksibenzoat (E 216) 0,2 mg/ml
English: Methyl parahydroxybenzoate (E 218) 1.6 mg/ml Propyl parahydroxybenzoate (E 216) 0.2 mg/ml
Slovenian: 1,6 mg/ml Propilparahidroksibenzoat (E 216) 0,2 mg/ml
English: Cats: In cases of overdosage, or if the effects of dexmedetomidine become potentially life-threatening, the appropriate antagonist is atipamezole, administered by intramuscular injection, at the following dose: 5 times the initial dose dexmedetomidine in micrograms/kg bw.
Slovenian: MAČKE: V primeru prevelikega odmerjanja, ali če postanejo učinki deksmedetomidina potencialno nevarni za življenje, uporabite atipamezol v obliki intramuskularne injekcije v naslednjem odmerku: 5-kratni prvotni odmerek deksmedetomidina v mikrogramih/kg telesne teže.
English: CATS: In cases of overdosage, or if the effects of dexmedetomidine become potentially life-threatening, the appropriate antagonist is atipamezole, administered by intramuscular injection, at the following dose: 5 times the initial dose dexmedetomidine in micrograms/kg bw.
Slovenian: Mačke: V primeru prevelikega odmerjanja, ali če postanejo učinki deksmedetomidina potencialno nevarni za življenje, uporabite atipamezol v obliki intramuskularne injekcije v naslednjem odmerku: 5-kratni prvotni odmerek deksmedetomidina v mikrogramih/kg telesne teže.
English: WASTE MATERIALS, IF ANY
Slovenian: UPORABE, če je smiselno
English: METHOD AND ROUTE(S) OF ADMINISTRATION Dogs: intravenous or intramuscular use Cats: intramuscular use
Slovenian: NAČIN IN POT(I) UPORABE Psi: intravenska ali intramuskularna uporaba Mačke: intramuskularna uporaba Pred uporabo preberite navodilo za uporabo.
English: PHARMACEUTICAL PARTICULARS 6.1 List of excipients Methyl parahydroxybenzoate (E 218) Propyl parahydroxybenzoate (E 216) 6.2 Incompatibilities
Slovenian: Metilparahidroksibenzoat (E 218) Propilparahidroksibenzoat (E 216)
English: ANNEX 127A CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT TO BE IMPLEMENTED BY THE MEMBER STATES
Slovenian: DODATEK 127A POGOJI ALI OMEJITVE V ZVEZI Z VARNO IN UČINKOVITO UPORABO ZDRAVILA, KI JIH IZVAJAJO DRŽAVE ČLANICE
English: • Caution in use in the elderly in light of age related risks (in particular bladder cancer, fractures and heart failure).
Slovenian: • Opozorilo o uporabi pri starejših glede na s starostjo povezana tveganja (zlasti za rak mehurja,
English: Manufacturer - Lilly S.A., Avda.
Slovenian: Izdelovalec • Lilly S.A., Avda.
English: Date of latest renewal: 8 August 2008
Slovenian: Datum zadnjega podaljšanja dovoljenja za promet: 8. avgust 2008
English: You should talk to your doctor first.
Slovenian: Predhodno se posvetujte z zdravnikom.
English: Due to the nature of this disease process, Evista is intended for long term use.
Slovenian: Zaradi narave tega bolezenskega procesa je zdravilo Evista namenjeno dolgotrajni uporabi.
English: D-81379 Munich Germany
Slovenian: D-81379 Munich Nemčija
English: Your doctor will tell you how long you should continue to take Evista.
Slovenian: Vaš zdravnik vam bo povedal, kako dolgo naj bi jemali zdravilo Evista.
English: A similar increase in BMD was seen in the treatment population who received Evista for up to 7 years.
Slovenian: Podobno povečanje BMD so ugotovili pri zdravljeni populaciji, ki je prejemala zdravilo Evista do 7 let.
English: • Headache including migraine
Slovenian: • Glavobol vključno z migreno
English: Common: Peripheral oedema
Slovenian: Pogosti: periferni edem
English: Like all medicines, this medicine can cause side effects although not everybody gets them.
Slovenian: Kot vsa zdravila ima lahko tudi to zdravilo neželene učinke, ki pa se ne pojavijo pri vseh bolnicah.
English: INFORMATION IN BRAILLE Evista
Slovenian: PODATKI V BRAILLOVI PISAVI Evista
English: Cholecystectomy rates for raloxifene (2.3 %) were not statistically significantly different from placebo (2.0 %).
Slovenian: Stopnje holecistomije za raloksifen (2,3 %) niso bile statistično značilno drugačne od placeba (2,0 %).
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 5 August 1998
Slovenian: DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJ ZA PROMET Z ZDRAVILOM Datum pridobitve dovoljenja za promet: 5. avgust 1998
English: If you are taking digitalis medicines for your heart or anticoagulants like warfarin to thin your blood, your doctor may need to adjust your dose of these medicines.
Slovenian: Če jemljete zdravila za srce, ki vsebujejo digitalis, ali antikoagulante za redčenje krvi, kakor je npr. varfarin, vam bo vaš zdravnik morda moral prilagoditi odmerek teh zdravil.
English: What Evista is and what it is used for
Slovenian: Kaj je zdravilo Evista in za kaj ga uporabljamo
English: What you need to know before you take Evista
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo Evista
English: The following convention has been used for the classification of the adverse reactions: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000).
Slovenian: Za klasifikacijo neželenih učinkov smo uporabili naslednji dogovor: zelo pogosto (≥ 1/10), pogosto (≥ 1/100 do < 1/10), občasno (≥ 1/1.000 do < 1/100), redko (≥ 1/10.000 do < 1/1.000), zelo redko
English: Evista tablets are packed either in PVC/PE/PCTFE blisters or in high density polyethylene bottles.
Slovenian: Tablete Evista so pakirane v pretisne omote PVC/PE/PCTFE ali v stekleničke iz polietilena visoke gostote.
English: Any uterine bleeding during Evista therapy is unexpected and should be fully investigated by a specialist.
Slovenian: Vsakršna krvavitev iz maternice med terapijo z zdravilom Evista je nepričakovana in jo mora v celoti raziskati specialist.
English: Take a tablet as soon as you remember and then continue as before.
Slovenian: Če ste pozabili vzeti zdravilo Evista Vzemite tableto takoj, ko se spomnite, in potem nadaljujte enako kot prej.
English: The majority of a dose of raloxifene and glucuronide metabolites are excreted within 5 days and are found primarily in the faeces, with less than 6 % excreted in urine.
Slovenian: Večji del odmerka raloksifena in njegovih glukuronidnih presnovkov se izloči v roku 5 dni in jih najdemo predvsem v blatu, manj kot 6 % pa se jih izloči z urinom.
English: Do not take a double dose to make up for a forgotten tablet dose.
Slovenian: Ne vzemite dvojnega odmerka, če ste pozabili vzeti prejšnji odmerek.
English: Evista may affect the development of the baby.
Slovenian: Zdravilo Evista lahko vpliva na dojenčkov razvoj.
English: After 3 years therapy Evista decreased fibrinogen (6.71 %).
Slovenian: Po 3 letih terapije z zdravilom Evista je znižana vrednost fibrinogena (6,71 %).
English: Evista could harm your unborn child.
Slovenian: Zdravilo Evista lahko poškoduje vašega nerojenega otroka.
English: Endometrial biopsies taken after six months therapy with Evista 60 mg daily demonstrated nonproliferative endometrium in all patients.
Slovenian: Biopsija endometrija po šestih mesecih terapije z zdravilom Evista v odmerku 60 mg na dan je pri vseh bolnicah pokazala neproliferativni endometrij.
English: Do not take Evista:
Slovenian: Ne jemljite zdravila Evista:
English: Effects on prothrombin time may develop over several weeks if Evista treatment is started in patients who are already on coumarin anticoagulant therapy.
Slovenian: Vplivi na protrombinski čas se lahko pokažejo šele čez nekaj tednov, če zdravljenje z zdravilom Evista uvedemo pri bolnicah, ki so že na kumarinski antikoagulantni terapiji.
English: • If there is still a possibility that you can get pregnant, Evista could harm your unborn child.
Slovenian: • Če je še vedno možnost, da lahko zanosite, saj zdravilo Evista lahko poškoduje vašega nerojenega otroka.
English: Evista should not be used in patients with signs or symptoms of endometrial cancer as safety in this patient group has not been adequately studied.
Slovenian: Zdravila Evista ne bi smeli uporabljati pri bolnicah, ki kažejo znake ali imajo simptome raka endometrija, saj varnost zdravila pri tej skupini bolnic še ni bila zadosti raziskana.
English: Data suggests that the oestrogen receptor can regulate gene expression by at least two distinct pathways which are ligand-, tissue-, and/or genespecific.
Slovenian: Podatki kažejo, da lahko estrogenski receptor regulira gensko ekspresijo po vsaj dveh različnih poteh, ki sta specifični za ligand, tkivo in/ali gen.
English: Raloxifene has no or negligible influence on the ability to drive and use machines.
Slovenian: Raloksifen nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja strojev.
English: Evista was associated with reduced bone resorption and a mean positive shift in calcium balance of 60 mg per day, due primarily to decreased urinary calcium losses.
Slovenian: Uporaba zdravila Evista je bila povezana z zmanjšano resorpcijo kostnega tkiva in s srednjim pozitivnim premikom ravnotežja kalcija za 60 mg na dan, kar je bilo predvsem posledica zmanjšane izgube kalcija z urinom.
English: It is important that you continue taking Evista for as long as your doctor prescribes the medicine.
Slovenian: Pomembno je, da nadaljujete z jemanjem zdravila Evista toliko časa kot vam je predpisal vaš zdravnik.
English: From the 4th to the 8th year, patients were permitted the concomitant use of bisphosphonates, calcitonin and fluorides and all patients in this study received calcium and vitamin D supplementation.
Slovenian: Od četrtega do osmega leta zdravljenja so bolnicam dovolili sočasno jemanje difosfonatov, kalcitonina in fluoridov in vse bolnice iz te raziskave so jemale dodatke kalcija in vitamina D.
English: ii) Bone Mineral Density (BMD): The efficacy of Evista once daily in postmenopausal women aged up to 60 years and with or without a uterus was established over a two-year treatment period.
Slovenian: ii) Mineralna kostna gostota (BMD): Učinkovitost zdravljenja z zdravilom Evista enkrat dnevno so ugotavljali pri ženskah po menopavzi, starih do 60 let, z maternico ali brez nje, in sicer med 2-letnim zdravljenjem s tem zdravilom.
English: If you have been told by your doctor that you have an intolerance to lactose, a type of sugar, contact your doctor before taking this medicinal product.
Slovenian: Če vam je zdravnik povedal, da ne prenašate laktoze, ki je vrsta sladkorja, se pred uporabo tega zdravila posvetujte z zdravnikom.
English: Evista is for use only by postmenopausal women and must not be taken by women who could still have a baby.
Slovenian: Zdravilo Evista je namenjeno le ženskam po menopavzi in je ne smejo jemati ženske, ki bi še lahko zanosile.
English: Clinical trials showed that a 60 mg daily dose of Evista significantly decreased total cholesterol (3 to 6 %), and LDL cholesterol (4 to 10 %).
Slovenian: Klinične raziskave so pokazala, da dnevni odmerek zdravila Evista 60 mg značilno zniža vrednosti skupnega holesterola (3 do 6 %) in LDL holesterola (4 do 10 %).
English: Other medicines and Evista
Slovenian: Druga zdravila in zdravilo Evista
English: However, if you have taken oestrogen in the past and had extreme elevations in triglycerides, you should talk to your doctor before taking Evista.
Slovenian: Če ste v preteklosti že jemali estrogene in ob tem imeli močno zvišane vrednosti trigliceridov, se pred jemanjem zdravila Evista pogovorite z zdravnikom.
English: Evista is not effective in reducing vasodilatation (hot flushes), or other symptoms of the menopause associated with oestrogen deficiency.
Slovenian: Evista ni učinkovito zdravilo za zmanjševanje vazodilatacije (navalov vročine) ali drugih simptomov menopavze, ki so povezani s pomanjkanjem estrogena.
English: In addition, in a study with 2.5 x the recommended daily dose of Evista there was no evidence of endometrial proliferation and no increase in uterine volume.
Slovenian: Poleg tega v raziskavi z 2,5-kratnim priporočenim dnevnim odmerkom zdravila Evista ni bilo nobenih znakov proliferacije endometrija in niso ugotovili povečanja prostornine maternice.
English: Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription.
Slovenian: Obvestite zdravnika ali farmacevta, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo.
English: b) Effects on lipid metabolism and cardiovascular risk
Slovenian: b) Vplivi na presnovo lipidov in srčnožilno tveganje
English: Tell your doctor if you are taking cholestyramine which is mainly used as lipid-lowering medicine, because Evista may not work as well.
Slovenian: Obvestite svojega zdravnika, če jemljete holestiramin, ki se uporablja predvsem kot zdravilo za zniževanje koncentracij lipidov v krvi, saj zdravilo Evista v tem primeru morda ne bo delovalo dovolj dobro.
English: Evista belongs to a group of non-hormonal medicines called Selective Oestrogen Receptor Modulators (SERMs).
Slovenian: Zdravilo Evista sodi v skupino nehormonskih zdravil, imenovano selektivni modulatorji estrogenskega receptorja.
English: No data are available on the concomitant use of Evista and agents used in the treatment of early or advanced breast cancer.
Slovenian: Tako ni podatkov o sočasnem zdravljenju z zdravilom Evista in drugimi zdravili, ki se uporabljajo za zdravljenje zgodnjega ali napredovalega raka dojke.
English: Evista has no effect on the risk of ER negative breast cancers.
Slovenian: Zdravilo Evista ne vpliva na tveganje za ER negativne vrste raka dojke.
English: Evista should not be used in children of any age.
Slovenian: Zdravila Evista ne smemo uporabljati pri otrocih katerekoli starosti.
English: Three trials included 1,764 postmenopausal women who were treated with Evista and calcium or calcium supplemented placebo.
Slovenian: V treh kliničnih preskušanjih je sodelovalo 1.764 žensk po menopavzi, ki so bile zdravljene z zdravilom Evista in dodatki kalcija ali s placebom in dodatki kalcija.
English: In the RUTH study overall clinical fractures were collected as a secondary endpoint.
Slovenian: V študiji RUTH so kot sekundarni cilj zbirali podatke o celotnih kliničnih zlomih.
English: • If you are suffering from breast cancer, as there is insufficient experience of Evista use in women with this disease.
Slovenian: • Če imate raka dojke, ker ni zadosti izkušenj z uporabo zdravila Evista pri ženskah s to boleznijo.
English: No dose adjustment is necessary for the elderly.
Slovenian: Starejši: Pri starejših ni potrebna prilagoditev odmerkov.
English: - The other ingredients are:
Slovenian: - Druge sestavine zdravila (pomožne snovi so):
English: SPECIAL STORAGE CONDITIONS Store in the original package.
Slovenian: POSEBNA NAVODILA ZA SHRANJEVANJE Shranjujte v originalni ovojnini.
English: The hazard ratio for all VTE events in the RUTH study was HR = 1.44 (1.06 - 1.95).
Slovenian: Razmerje tveganja za vse venske tromboembolične zaplete v študiji RUTH je bilo HR = 1,44, (1,66 - 1,95).
English: If you stop taking Evista
Slovenian: Če ste prenehali jemati zdravilo Evista
English: Do not take Evista if you are breast-feeding as it might be excreted in mother's milk.
Slovenian: Ne jemljite zdravila Evista, če dojite, saj lahko zdravilo prehaja v materino mleko.
English: Systemic exposure (AUC) of raloxifene in this group was approximately 400 times that in postmenopausal women administered a 60 mg dose.
Slovenian: Sistemska izpostavljenost raloksifenu (AUC) v tej skupini preiskovanih podgan je bila približno 400-krat večja od vrednosti za ženske po menopavzi, ki dobi odmerek 60 mg.
English: The clinically most important adverse reactions reported in postmenopausal women treated with Evista were venous thromboembolic events (see section 4.4), which occurred in less than 1% of treated patients.
Slovenian: Klinično najpomembnejši neželeni učinki, o katerih so poročali pri postmenopavzalnih ženskah, ki so se zdravile z zdravilom Evista, so bili venski tromboembolični dogodki (glejte poglavje 4.4), ki so se pojavili pri manj kot 1 % zdravljenih bolnicah.
English: Frequently co-administered medicinal products included: paracetamol, non-steroidal anti-inflammatory drugs (such as acetylsalicylic acid, ibuprofen, and naproxen), oral antibiotics, H1 antagonists, H2 antagonists, and benzodiazepines.
Slovenian: Zdravila, ki so jih pogosto dajali sočasno, so bila: paracetamol, nesteroidna protivnetna zdravila (kakor so npr. acetilsalicilna kislina, ibuprofen in naproksen), peroralni antibiotiki, antagonisti H1 receptorjev, antagonisti H2 receptorjev in benzodiazepini.
English: Evista (n = 317) was compared with continuous combined (n = 110) hormone replacement therapy (HRT) or cyclic (n = 205) HRT patients in some clinical trials.
Slovenian: Zdravilo Evista (n = 317) so v nekaterih kliničnih preskušanjih primerjali s kontinuirano kombinirano (n = 110) hormonsko nadomestno terapijo (HRT - hormone replacement therapy) ali s ciklično HRT (n = 205).
English: Evista can treat or prevent your osteoporosis only if you continue to take the tablets.
Slovenian: Zdravilo Evista lahko zdravi in preprečuje osteoporozo samo, če nadaljujete z jemanjem tablet.
English: When determining the choice of Evista or other therapies, including oestrogens, for an individual postmenopausal woman, consideration should be given to menopausal symptoms, effects on uterine and breast tissues, and cardiovascular risks and benefits (see section 5.1).
Slovenian: Ko se zdravnik pri posamezni ženski po menopavzi odloča med zdravilom Evista ali drugimi oblikami zdravljenja, vključno z estrogeni, mora pri tem upoštevati simptome menopavze pri njej in učinke zdravila na tkivo maternice in dojke ter pretehtati koristi in tveganja za srčnožilna obolenja (glejte poglavje 5.1).
English: • If you have active uterine cancer, as there is insufficient experience of Evista use in women with this disease.
Slovenian: • Če imate aktivni rak maternice, saj pri ženskah s to boleznijo ni zadostnih izkušenj z uporabo zdravila Evista.
English: Forty five women with osteoporosis or 15 women with osteoporosis with an existing fracture would need to be treated with Evista for 3 years to prevent one or more vertebral fractures.
Slovenian: Da bi preprečili enega ali več zlomov vretenc, bi bilo treba z zdravilom Evista zdraviti petinštirideset žensk z osteoporozo ali 15 žensk z osteoporozo in obstoječim zlomom 3 leta.
English: Likewise, Evista is indicated for the treatment of osteoporosis or established osteoporosis in women with BMD of the spine 2.5 SD below the mean value of a normal young population and/or with vertebral fractures, irrespective of BMD.
Slovenian: Podobno velja, da je zdravilo Evista indicirano za zdravljenje osteoporoze ali ugotovljene osteoporoze pri ženskah, ki imajo vrednosti BMD za hrbtenico za 2,5 SD nižje od srednje vrednosti zdrave mlade populacije in/ali imajo zlome vretenc, ne glede na vrednosti BMD.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/98/073/004
Slovenian: ŠTEVILKA(E) DOVOLJENJA(DOVOLJENJ) ZA PROMET EU/1/98/073/004
English: Uncommon: Fatal strokes
Slovenian: Občasni: smrtne kapi