FrancophonIA/ELRC3.0 huggingface dataset:
English: The active substance in each Sonata hard capsule is zaleplon 10 mg.
Slovenian: Zdravilna učinkovina: v eni trdi kapsuli Sonata je 10 mg zaleplona.
English: Use (even at therapeutic doses) may lead to the development of physical dependence: discontinuation of therapy may result in withdrawal or rebound phenomena (see section 4.4).
Slovenian: prekinitev terapije lahko povzroči odtegnitvene simptome ali povratni fenomen (glejte poglavje 4.4).
English: If you experience any of these events, contact your doctor immediately.
Slovenian: Če pri sebi opazite kaj od naštetega, se nemudoma posvetujte z zdravnikom.
English: The active substance in each Sonata hard capsule is zaleplon 5 mg.
Slovenian: Zdravilna učinkovina: v eni trdi kapsuli Sonata je 5 mg zaleplona.
English: As clearance is reduced, patients with mild to moderate hepatic impairment should be treated with Sonata 5 mg. For severe hepatic impairment see section 4.3.
Slovenian: Ker je očistek zdravila zmanjšan, morate bolnike z blago do zmerno jetrno okvaro zdraviti z zdravilom Sonata
English: MARKETING AUTHORISATION NUMBER(S) EU/1/99/102/004 7 capsules
Slovenian: ŠTEVILKA(E) DOVOLJENJA(DOVOLJENJ) ZA PROMET EU/1/99/102/004 7 kapsul
English: amnesia, paraesthesia, somnolence ataxia/coordination abnormal, dizziness, disturbance in attention, parosmia, speech disorder (dysarthria, slurred speech), hypoaesthesia
Slovenian: Glejte tudi spodaj pod amnezijo amnezija, parestezije, zaspanost ataksija/nekoordiniranost gibov, vrtoglavica, zmanjšana koncentracija, parosmija; motnje govora (dizartrija,
English: Excipient with known effect: Lactose monohydrate 54 mg. For the full list of excipients, see section 6.1.
Slovenian: Pomožne snovi z znanim učinkom: 54 mg laktoze monohidrata
English: An allergic reaction may include a rash, itching, difficulty breathing or swelling of the face, lips, throat or tongue, or nausea and vomiting.
Slovenian: Alergijska reakcija lahko obsega izpuščaj, srbenje, oteženo dihanje ali otekanje obraza, ustnic, žrela ali jezika ali slabost in bruhanje Če pri sebi opazite kaj od naštetega, se nemudoma posvetujte z zdravnikom.
English: Chromaturia (bluegreen urine discolouration) has been reported with zaleplon overdose.
Slovenian: Pri prevelikem odmerjanju zaleplona so poročali o kromaturiji (modro-zelena obarvanost urina).
English: Sonata 5 mg hard capsules zaleplon
Slovenian: Sonata 5 mg trde kapsule zaleplon
English: Other complex behaviours (e.g., preparing and eating food, making phone calls, or having sex) have been reported in patients who are not fully awake after taking a sedative-hypnotic.
Slovenian: Pri bolnikih, ki po tistem, ko vzamejo sedativ/hipnotik, niso povsem budni, so poročali še o drugih vrstah kompleksnega vedenja (npr. priprava in uživanje hrane, telefoniranje ali spolno občevanje).
English: Reactions like restlessness, agitation, irritability, decreased inhibition, aggressiveness, abnormal thinking, delusions, rages, nightmares, depersonalisation, hallucinations, psychoses, inappropriate behaviour, extroversion that seems out of character, and other adverse behavioural reactions are known to occur when using benzodiazepines or benzodiazepine-like agents.
Slovenian: Reakcije kot so nemir, vznemirjenost, razdražljivost, popustitev zavor, agresivnost, nenormalno mišljenje, zablode, bes, nočne more, občutki depersonalizacije, halucinacije, psihoza, neprimerno vedenje, ekstrovertnost, ki se zdi pretirana, ter druge neželene vedenjske reakcije se lahko pojavijo ob uporabi benzodiazepinov ali njim sorodnih učinkovin.
English: Some loss of efficacy to the hypnotic effects of short-acting benzodiazepines and benzodiazepine-like agents may develop after repeated use for a few weeks.
Slovenian: Po nekajtedenski zaporedni uporabi lahko nastopi zmanjšanje uspavalnega učinka kratkotrajno delujočih benzodiazepinov in njim sorodnih učinkovin.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/99/102/001 7 capsules
Slovenian: ŠTEVILKA(E) DOVOLJENJA(DOVOLJENJ) ZA PROMET EU/1/99/102/001 7 kapsul
English: Ingredients of the capsule shell: gelatin, titanium dioxide (E171) and sodium lauryl sulphate.
Slovenian: Sestavine ovojnice kapsule: želatina, titanov dioksid (E171) in natrijev lavrilsulfat.
English: If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Slovenian: Če ste noseči ali dojite, menite, da bi lahko bili noseči ali načrtujete zanositev, se posvetujte z zdravnikom ali farmacevtom, preden vzamete to zdravilo.V tem primeru ne smete jemati zdravila Sonata, saj ni na voljo dovolj kliničnih podatkov za oceno varnosti jemanja zdravila Sonata med nosečnostjo.
English: EU/1/99/102/002 10 capsules EU/1/99/102/003 14 capsules
Slovenian: EU/1/99/102/003 14 kapsul
English: Tel: +420 234 064 203
Slovenian: CZ 100 10 Praha 10 Tel: +420 234 064 203
English: • Reactions like restlessness, agitation, irritability, aggressiveness, abnormal thinking, delusion, rages, nightmares, depersonalisation, hallucinations, psychoses, inappropriate behaviour, extroversion that seems out of character and other behavioural effects have been reported following use of any medicines belonging to the sleep inducing group, including Sonata.
Slovenian: besnost, nočne more, depersonalizacija, halucinacije, psihoze, neprimerno vedenje, ekstrovertiranost, ki se zdi pretirana, in drugi vedenjski učinki pri uporabi katerih koli zdravil, ki spadajo med uspavala, tudi zdravila Sonata.
English: EU/1/99/102/005 10 capsules EU/1/99/102/006 14 capsules
Slovenian: EU/1/99/102/006 14 kapsul
English: Severe respiratory insufficiency
Slovenian: Hude težave z dihanjem
English: Therefore, no dose adjustment is necessary in patients with mild to moderate renal impairment.
Slovenian: Pri bolnikih z blago do zmerno ledvično okvaro torej ni treba prilagajati odmerka.
English: NAME OF THE MEDICINAL PRODUCT Sonata 10 mg hard capsules
Slovenian: IME ZDRAVILA Sonata 10 mg trde kapsule
English: NAME OF THE MEDICINAL PRODUCT Sonata 5 mg hard capsules
Slovenian: IME ZDRAVILA Sonata 5 mg trde kapsule
English: Therapy of overdose
Slovenian: Zdravljenje prevelikega odmerjanja
English: Sonata 10 mg hard capsules zaleplon
Slovenian: Sonata 10 mg trde kapsule zaleplon
English: Capsule shell gelatin, titanium dioxide (E171), sodium lauryl sulphate,
Slovenian: Ovojnica kapsule: želatina titanov dioksid (E171) natrijev lavrilsulfat
English: Sleep apnoea syndrome
Slovenian: Sindrom apneje v spanju
English: Microcrystalline cellulose, pregelatinised starch, silicon dioxide, sodium lauryl sulphate, magnesium stearate, lactose monohydrate, indigo carmine (E132), titanium dioxide (E171).
Slovenian: Jedro kapsule: mikrokristalna celuloza predgeliran škrob silicijev dioksid natrijev lavrilsulfat magnezijev stearat laktoza monohidrat indigo karmin (E132) titanov dioksid (E171)
English: Do not go unaccompanied to seek medical help.
Slovenian: Če rabite zdravniško pomoč, obiščite zdravnika s spremstvom.
English: In a pre- and postnatal development study in rats, increased stillbirth and postnatal mortality, and decreased growth and physical development, were observed in the offspring of females treated with doses of ≥7 mg/kg/day that did not elicit maternal toxicity.
Slovenian: V študiji prenatalnega in postnatalnega razvoja pri podganah so pri potomcih samic, zdravljenih z odmerkom
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 5 mg of zaleplon.
Slovenian: Vsaka kapsula vsebuje 5 mg zaleplona.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 10 mg of zaleplon.
Slovenian: Vsaka kapsula vsebuje 10 mg zaleplona.
English: Rebound insomnia and anxiety
Slovenian: Povrnitev nespečnosti in tesnoba
English: Excipient with known effect: Lactose monohydrate 49 mg. For the full list of excipients, see section 6.1.
Slovenian: Pomožne snovi z znanim učinkom: 49 mg laktzoze monohidrata
English: NAME OF THE MEDICINAL PRODUCT Sonata 5 mg hard capsules zaleplon
Slovenian: IME ZDRAVILA Sonata 5 mg trde kapsule zaleplon
English: NAME OF THE MEDICINAL PRODUCT Sonata 10 mg hard capsules zaleplon
Slovenian: IME ZDRAVILA Sonata 10 mg trde kapsule zaleplon
English: Hepatic impairment
Slovenian: Očesne bolezni
English: MEDA Pharma GmbH & Co. KG Benzstraße 1
Slovenian: KG Benzstraße 1
English: If you have any further questions, ask your doctor or pharmacist.
Slovenian: V primeru dodatnih vprašanj se posvetujte z zdravnikom ali farmacevtom.
English: MEDA Pharma B.V. Krijgsman 20
Slovenian: MEDA Pharma B.V.
English: Capsule shell gelatin, titanium dioxide (E171), red iron oxide (E172), yellow iron oxide (E172), black iron oxide (E172), sodium lauryl sulphate,
Slovenian: Ovojnica kapsule: želatina titanov dioksid (E171) rdeči železov oksid (E172) rumeni železov oksid (E172)
English: Severe anaphylactic/anaphylactoid reactions have been reported with the use of sedative-hypnotics, including zaleplon.
Slovenian: Pri jemanju sedativov/hipnotikov, vključno z zaleplonom, so poročali o hudih anafilaktičnih/anafilaktoidnih reakcijah.
English: Ear and labyrinth disorders Uncommon:
Slovenian: Ušesne bolezni,vključno z motnjami labirinta Občasno:
English: Reactions like restlessness, agitation, irritability, decreased inhibition, aggressiveness, abnormal thinking, delusion, rages, nightmares, depersonalisation, hallucinations, psychoses, inappropriate behaviour, extroversion that seems out of character and other behavioural effects are known to occur when using benzodiazepines or benzodiazepine-like agents.
Slovenian: zabloda, bes, nočne more, depersonalizacija, halucinacije, psihoze, neprimerno vedenje, ekstrovertiranost, ki se zdi pretirana, ter drugi vedenjski učinki se lahko pojavijo ob uporabi benzodiazepinov ali njim sorodnih učinkovin.
English: CZ 100 10 Praha 10
Slovenian: 7 trdih kapsul 10 trdih kapsul 14 trdih kapsul
English: There is no pharmacokinetic interaction between zaleplon and diphenhydramine following the administration of a single dose (10 mg and 50 mg, respectively) of each drug.
Slovenian: Po uporabi enkratnega odmerka (10 mg oziroma 50 mg) posameznega zdravila ne pride do farmakokinetičnih interakcij med zaleplonom in difenhidraminom.
English: Elderly
Slovenian: Presnova
English: Skin and subcutaneous tissue disorders Uncommon:
Slovenian: Bolezni kože in podkožja
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 5 MG CAPSULE BLISTERS
Slovenian: PRETISNI OMOTI S 5 MG KAPSULAMI
English: capsule, hard
Slovenian: kapsula, trda
English: Invented name Strength
Slovenian: Izmišljeno ime
English: Annex I List of the invented names, pharmaceutical forms, strengths of the medicinal products, routes of administration, marketing authorisation holders in the member states
Slovenian: Priloga I Seznam izmišljenih imen, farmacevtskih oblik, jakosti zdravila, poti uporabe zdravila, imetnikov dovoljenja za promet z zdravilom v državah članicah
English: Pharmaceutical Form Route of administration
Slovenian: Farmacevtska oblika Pot uporabe
English: Actavis Deutschland GmbH & Co. KG Elisabeth-Selbert-Str. 1
Slovenian: KG Elisabeth-Selbert-Str. 1
English: Ikelan solution for injection or infusion 50mg/5ml injection
Slovenian: Ikelan solution for injection or infusion 50mg/5ml injekcija intramuskularna in intravenska uporaba
English: tablets
Slovenian: tablete
English: tablet
Slovenian: tableta
English: LOFTON 150 mg/ml gotas orales en solución oral drops solution
Slovenian: LOFTON 150 mg/ml gotas orales en solución peroralne kapljice, raztopina
English: LOFTON 150 mg comprimidos recubiertos coated tablet
Slovenian: LOFTON 150 mg comprimidos recubiertos obložena tableta
English: INTRAVENOUS INFUSION, INTRAVENOUS INJECTION, INTRAMUSCULAR
Slovenian: INTRAVENSKO INFUNDIRANJE, INTRAVENSKO INJICIRANJE, INTRAMUSKULARNA UPORABA
English: SOLUTION FOR INJECTION
Slovenian: RAZTOPINA ZA INJICIRANJE
English: AMDIPHARM LIMITED 3, TEMPLE CHAMBERS IRL DUBLIN
Slovenian: Luksemburg AMDIPHARM LIMITED 3, TEMPLE CHAMBERS IRL DUBLIN
English: Coated tablet
Slovenian: obložena tableta
English: BufloMed 'S.Med' 300 mg Filmtabletten 300 mg
Slovenian: BufloMed 'S.Med' 300 mg Filmtabletten
English: LOFTYL 50 mg/5 ml, solution injectable
Slovenian: LOFTYL 50 mg/5 ml, solution injectable 50 mg/5 ml raztopina za injiciranje intramuskularna in intravenska uporaba
English: BUFLOMEDIL SANDOZ 150 mg, comprimé 150 mg
Slovenian: BUFLOMEDIL SANDOZ 150 mg, comprimé 150 mg tableta
English: solution for injection intramuscular and intravenous use
Slovenian: raztopina za injiciranje intramuskularna in intravenska uporaba
English: BufloMed 'S.Med' retard 600 mg Filmtabletten prolonged-release tablet oral use
Slovenian: BufloMed 'S.Med' retard 600 mg Filmtabletten
English: oral drop, solution
Slovenian: peroralne kapljice, raztopina
English: BUFLOMEDIL ARROW 150 mg, comprimé 150 mg
Slovenian: BUFLOMEDIL ARROW 150 mg, comprimé 150 mg tableta
English: Buvasodil film coated tablets
Slovenian: Buvasodil filmsko obložene tablete peroralna uporaba
English: BUFLOMEDIL CRISTERS 150 mg, comprimé
Slovenian: BUFLOMEDIL CRISTERS 150 mg, comprimé tableta
English: FONZYLANE 150 mg, comprimé pelliculé 150 mg
Slovenian: LOFTYL 150 mg, comprimé pelliculé 150 mg
English: BUFLOMEDIL ACTAVIS 150 mg, comprimé
Slovenian: BUFLOMEDIL ACTAVIS 150 mg, comprimé tableta
English: BUFLOMEDIL ZYDUS 150 mg, comprimé
Slovenian: BUFLOMEDIL ZYDUS 150 mg, comprimé tableta
English: CONTROLLED RELEASE TABLET
Slovenian: TABLETA S PRIREJENIM SPROŠČANJEM
English: Buflomedil-CT 50mg/5ml Ampullen
Slovenian: Buflomedil-CT 50mg/5ml Ampullen 50mg / 5ml raztopina za injiciranje, raztopina za infundiranje intravenska in intramuskularna uporaba
English: BUFLOMEDIL RPG 150 mg, comprimé
Slovenian: BUFLOMEDIL RPG 150 mg, comprimé tableta
English: Complamin Buflomedil Injekt
Slovenian: Complamin Buflomedil Injekt raztopina za injiciranje intravenska in intramuskularna uporaba
English: coated tablet
Slovenian: OBLOŽENA TABLETA peroralna uporaba
English: Pharmaceutical Form Route of Administration
Slovenian: Farmacevtska oblika Pot uporabe
English: Content Package size
Slovenian: Velikost pakiranja
English: EU Number
Slovenian: Številka EU Zaščiteno ime
English: Packaging
Slovenian: Ovojnina
English: Content (concentration)
Slovenian: Pot uporabe Stična ovojnina Vsebina (koncentracija)
English: MA (EU) number (Invented) name Strength
Slovenian: Številka (EU) dovoljenja za promet
English: Immediate Packaging
Slovenian: Stična ovojnina Velikost pakiranja e
English: The main areas harmonised include:
Slovenian: Med glavnimi usklajenimi področji so:
English: Other changes
Slovenian: Druge spremembe
English: Outcome of a procedure under Article 30 of Directive 2001/83/EC
Slovenian: Izid postopka po členu 30 Direktive 2001/83/ES
English: 22 May 2012
Slovenian: 22. maj 2012
English: The amended information to doctors and patients is available here.
Slovenian: Spremenjene informacije za zdravnike in bolnike so na voljo tukaj.
English: The European Commission issued a decision on 22 May 2012.
Slovenian: Evropska komisija je sklep izdala dne 22. maja 2012.
English: Why was Femara reviewed?
Slovenian: Zakaj je bilo zdravilo Femara pregledano?
English: The CHMP was of the view that it was more appropriate to include relevant warnings in section 4.4.
Slovenian: CHMP je menil, da je ustreznejša vključitev zadevnih opozoril v poglavje 4.4.
English: Femara is authorised in the EU via national procedures.
Slovenian: Zdravilo Femara so odobrili v EU z nacionalnimi postopki.
English: On 15 March 2012, the European Medicines Agency completed a review of Femara.
Slovenian: Evropska agencija za zdravila je 15. marca 2012 dokončala pregled zdravila Femara.
English: Femara is marketed in all EU Member States and is also available under other trade names: Femar, Fémara, and Loxifan.
Slovenian: Zdravilo Femara se trži v vseh državah članicah EU in je na voljo tudi pod drugimi tržnimi imeni: Femar, Fémara in Loxifan.
English: 4.3 Contra-indications
Slovenian: 4.3 Kontraindikacije
English: What is Femara?
Slovenian: Kaj je zdravilo Femara?
English: On 31 August, the European Commission referred the matter to the CHMP in order to harmonise the marketing authorisations for Femara in the EU.
Slovenian: Evropska komisija je 31. avgusta zadevo napotila na CHMP z namenom uskladitve dovoljenj za promet z zdravilom Femara v EU.
English: Questions and answers on Femara and associated names (letrozole, 2.5 mg tablets)
Slovenian: Vprašanja in odgovori o zdravilu Femara in povezanih imenih (letrozol, 2,5 mg tablete)
English: Questions and answers on Femara and associated names (letrozole, 2.5 mg tablets) EMA/180824/2012
Slovenian: Vprašanja in odgovori o zdravilu Femara in povezanih imenih (letrozol, 2,5 mg tablete) EMA/180824/2012
English: The company that markets these medicines is Novartis.
Slovenian: Ta zdravila trži farmacevtska družba Novartis.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that there is a need to harmonise the prescribing information for Femara in the European Union (EU).
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da je treba uskladiti informacije o predpisovanju zdravila Femara v Evropski uniji (EU).
English: The CHMP also harmonised other sections of the SmPC including sections 4.6 (pregnancy and lactation) and 4.8 (side effects).
Slovenian: CHMP je uskladil tudi druga poglavja povzetka glavnih značilnosti zdravila, vključno s poglavjema 4.6 (nosečnost in dojenje) in 4.8 (neželeni učinki).
English: After reviewing the available data supporting the medicine's use, the CHMP agreed that Femara should be used in postmenopausal women for the following:
Slovenian: Po pregledu razpoložljivih podatkov, ki podpirajo uporabo zdravila, je CHMP soglašal, da se sme zdravilo Femara uporabljati pri ženskah po menopavzi za naslednje indikacije:
English: This has led to divergences across Member States in the way the medicine can be used, as seen in the differences in the summaries of product characteristics (SmPCs), labelling and package leaflets in the countries where the medicine is marketed.
Slovenian: To je povzročilo razlike med državami članicami glede načina, kako se zdravilo lahko uporablja, kar se izraža v razlikah med povzetki glavnih značilnosti zdravila, označevanji in navodili za uporabo v državah, kjer se zdravilo trži.
English: Femara is a medicine that contains the active substance letrozole.
Slovenian: Femara je zdravilo, ki vsebuje zdravilno učinkovino letrozol.
English: Having harmonised the indications, the CHMP also harmonised recommendations on the doses, duration of treatment and use of Femara in patients with reduced kidney or liver function.
Slovenian: Po uskladitvi indikacij je CHMP uskladil tudi priporočila o odmerkih, trajanju zdravljenja in uporabi zdravila Femara pri bolnicah z zmanjšanim delovanjem ledvic ali jeter.
English: In harmonising the contraindications, the CHMP decided against including two contraindications that were in the SmPCs of some EU countries: liver impairment and pre-operative use in patients whose receptor status is negative or unknown.
Slovenian: Pri usklajevanju kontraindikacij se je CHMP odločil za izključitev dveh kontraindikacij iz povzetkov glavnih značilnosti zdravila v nekaterih državah EU: okvare jeter in predoperativne uporabe pri bolnicah z negativnim ali neznanim receptorskim statusom.
English: By blocking the activity of aromatase and thereby reducing the amount of oestrogen produced, the medicine slows or stops the growth and spread of the cancer.
Slovenian: Ker zdravilo Femara zavira delovanje aromataze in s tem zmanjša količino estrogena, ki nastaja v telesu, posledično upočasni ali ustavi rast in širjenje raka.
English: It is used as hormonal treatment in postmenopausal women with breast cancer.
Slovenian: Uporablja se kot hormonsko zdravljenje raka dojke pri ženskah po menopavzi.
English: • Advanced breast cancer after relapse or disease progression, in women with natural or artificially induced postmenopausal endocrine status, who have previously been treated with anti-oestrogens.
Slovenian: • napredovali rak dojke ob ponovitvi ali napredovanju bolezni pri ženskah z naravnim ali umetno povzročenim pomenopavznim endokrinim stanjem, ki so se prej zdravile z antiestrogeni;
English: The active substance in Femara, letrozole, is an ‘aromatase inhibitor'.
Slovenian: Zdravilna učinkovina v zdravilu Femara, letrozol, je „zaviralec aromataze“.
English: The CHMP, in light of the data submitted and the scientific discussion within the Committee, was of the opinion that the SmPCs, labelling and package leaflets should be harmonised across the EU.
Slovenian: CHMP je ob upoštevanju predloženih podatkov in znanstvene razprave v odboru odločil, da je treba uskladiti povzetke glavnih značilnosti zdravila, označevanje in navodila za uporabo v vsej EU.
English: Femara is used in postmenopausal women because aromatase is involved in producing most of the oestrogen in this population.
Slovenian: Zdravilo Femara se uporablja pri ženskah po menopavzi, ker v tej skupini bolnic aromataza sodeluje pri tvorbi večine estrogena.
English: In some types of breast cancer (hormone receptor positive or hormone-dependent types), oestrogen is known to stimulate the growth of the cancer cells.
Slovenian: Znano je, da estrogen pri nekaterih vrstah raka dojke (s pozitivnimi hormonskimi receptorji ali hormonsko odvisnih vrstah) spodbuja rast rakastih celic.
English: • Neo-adjuvant (pre-surgery) treatment of hormone receptor positive, HER-2 negative breast cancer where chemotherapy is not suitable and immediate surgery not indicated.
Slovenian: • neoadjuvantno (predoperativno) zdravljenje HER-2-negativnega raka dojke s pozitivnimi hormonskimi receptorji, kadar kemoterapija ni primerna in takojšnji kirurški poseg ni indiciran.
English: • Extended adjuvant treatment of hormone-dependent invasive breast cancer in women who have received prior standard adjuvant tamoxifen therapy for five years.
Slovenian: • podaljšano adjuvantno zdravljenje invazivnega hormonsko odvisnega raka dojke pri ženskah, ki so se pred tem pet let zdravile s standardno adjuvantno terapijo s tamoksifenom;
English: • First-line treatment for hormone-dependent advanced breast cancer.
Slovenian: • prva izbira za zdravljenje napredovalega hormonsko odvisnega raka dojke;
English: This means that it works by blocking the action of an enzyme called ‘aromatase', which is involved in the production of the hormone oestrogen.
Slovenian: To pomeni, da deluje z zaviranjem delovanja encima aromataze, ki sodeluje pri tvorbi hormona estrogena.
English: • Adjuvant (post-surgery) treatment of hormone receptor positive invasive early breast cancer.
Slovenian: • adjuvantno (pooperativno) zdravljenje zgodnjega invazivnega raka dojke s pozitivnimi hormonskimi receptorji;
English: Femara was identified as needing harmonisation by the Co-ordination Group on the Mutual and Decentralised Procedures - Human (CMD(h)).
Slovenian: Usklajevalna skupina za postopek z medsebojnim priznavanjem in decentralizirani postopek za zdravila za uporabo v humani medicini (CMD(h)) je ugotovila, da je za zdravilo Femara potrebna uskladitev.
English: The process takes about 6 to 8 weeks.
Slovenian: Postopek traja od 6 do 8 tednov.
English: 72 hours
Slovenian: 72 ur
English: This may take up to one year.
Slovenian: To lahko traja do enega leta.
English: The physician will be informed immediately.
Slovenian: Zdravnik bo o tem nemudoma obveščen.
English: The program may take up to one year depending on the recommendation of the physician.
Slovenian: Program lahko traja do enega leta, odvisno od zdravnikovih priporočil.
English: The treatment groups were balanced with respect to size, demography and disease background.
Slovenian: Skupine zdravljenja so bile uravnotežene glede na velikost, demografijo in ozadje bolezni.
English: • Primary (generalised) osteoarthritis.
Slovenian: • Primarni (generalizirani) osteoartritis.
English: Dispose of in accordance with local requirements.
Slovenian: Odstranite v skladu z lokalnimi zahtevami.
English: Your doctor might have to select an alternative treatment for you.
Slovenian: Zdravnik bo morda za vas moral izbrati drugo zdravljenje.