FrancophonIA/ELRC3.0 huggingface dataset:
English: For patients switching from co-administration of sitagliptin and metformin For patients switching from co-administration of sitagliptin and metformin, Efficib should be initiated at the dose of sitagliptin and metformin already being taken.
Slovenian: Pri bolnikih, ki prehajajo s sočasnega jemanja sitagliptina in metformina Pri bolnikih, ki prehajajo s sočasnega jemanja sitagliptina in metformina, je treba zdravljenje z zdravilom Efficib začeti z odmerkom sitagliptina in metformina, ki ga že jemljejo.
English: A bioequivalence study in healthy subjects demonstrated that the Efficib (sitagliptin/metformin hydrochloride) combination tablets are bioequivalent to co-administration of sitagliptin phosphate and metformin hydrochloride as individual tablets.
Slovenian: V bioekvivalenčni študiji pri zdravih osebah so pokazali, da so kombinirane tablete Efficib (sitagliptin/metforminijev klorid) bioekvivalentne sočasni uporabi sitagliptinijevega fosfata in metforminijevega klorida v obliki posameznih tablet.
English: As metformin and sitagliptin are excreted by the kidney, Efficib should be used with caution as age increases.
Slovenian: Metformin in sitagliptin se izločata skozi ledvice, zato je pri uporabi zdravila Efficib pri starejših potrebna previdnost.
English: If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking Efficib.
Slovenian: Če niste prepričani, če kar koli od navedenega velja za vas, se pred začetkom jemanja zdravila Efficib, posvetujte z zdravnikom ali farmacevtom.
English: Efficib must therefore not be used in women who are breast-feeding (see section 4.3).
Slovenian: Zato ženske, ki dojijo, zdravila Efficib ne smejo jemati (glejte poglavje 4.3).
English: Efficib should not be used during pregnancy.
Slovenian: Bolnice med nosečnostjo ne smejo jemati zdravila Efficib.
English: When Efficib is used in combination with insulin, a lower dose of insulin may be required to reduce the risk of hypoglycaemia (see section 4.4).
Slovenian: Kadar se zdravilo Efficib uporablja v kombinaciji z insulinom, bo morda potreben manjši odmerek insulina za zmanjšanje tveganja za hipoglikemijo (glejte poglavje 4.4).
English: When Efficib is used in combination with a sulphonylurea, a lower dose of the sulphonylurea may be required to reduce the risk of hypoglycaemia (see section 4.4).
Slovenian: Kadar se zdravilo Efficib uporablja v kombinaciji s sulfonilsečnino, bo morda potreben manjši odmerek sulfonilsečnine za zmanjšanje tveganja za hipoglikemijo (glejte poglavje 4.4).
English: Patients receiving Efficib in combination with a sulphonylurea or with insulin may be at risk for hypoglycaemia.
Slovenian: Pri bolnikih, ki prejemajo zdravilo Efficib v kombinaciji s sulfonilsečnino ali z insulinom, se lahko pojavi tveganje za hipoglikemijo.
English: Efficib has no or negligible influence on the ability to drive and use machines.
Slovenian: Zdravilo Efficib nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja strojev.
English: If a hypersensitivity reaction is suspected, Efficib should be discontinued, other potential causes of the event should be assessed, and alternative treatment for diabetes should be instituted (see section 4.8).
Slovenian: Pri sumu na preobčutljivostne reakcije morate zdravljenje z zdravilom Efficib prekiniti, oceniti druge morebitne vzroke za ta neželeni učinek in začeti zdraviti sladkorno bolezen z drugimi zdravili (glejte poglavje 4.8).
English: There have been no therapeutic clinical trials conducted with Efficib tablets however bioequivalence of Efficib with co-administered sitagliptin and metformin has been demonstrated (see section 5.2).
Slovenian: Kliničnih terapevtskih preskušanj z zdravilom Efficib niso izvedli, vendar pa so dokazali bioekvivalenco zdravila Efficib in sočasne uporabe sitagliptina in metformina (glejte poglavje 5.2).
English: You will need to stop taking Efficib at the time of the X-ray and for 2 or more days after as directed by your doctor,
Slovenian: Zdravilo Efficib morate prenehati jemati na dan rentgenskega pregleda in ga ne smete jemati še 2 ali več dni po njem, kot vam je naročil zdravnik, odvisno od delovanja vaših ledvic.
English: Efficib is indicated as an adjunct to diet and exercise to improve glycaemic control in patients inadequately controlled on their maximal tolerated dose of metformin alone or those already being treated with the combination of sitagliptin and metformin.
Slovenian: Zdravilo Efficib je indicirano kot dodatek dieti in telesni aktivnosti za izboljšanje urejenosti glikemije pri bolnikih z neustrezno nadzorovano sladkorno boleznijo pri jemanju največjega odmerka samega metformina, ki ga prenašajo, ali pri bolnikih, ki že prejemajo kombinacijo sitagliptina in metformina.
English: Efficib must be discontinued prior to or at the time of the imaging procedure and not restarted until at least 48 hours after, provided that renal function has been re-evaluated and found to be stable (see sections 4.3 and 4.4).
Slovenian: Zdravilo Efficib je treba pred slikanjem ali v času slikanja ukiniti in se ga sme ponovno uvesti najmanj 48 ur pozneje, če je bilo delovanje ledvic ponovno ovrednoteno in ocenjeno kot stabilno (glejte poglavji 4.3 in 4.4).
English: How to take Efficib
Slovenian: Kako jemati zdravilo Efficib
English: Cases of inflammation of the pancreas (pancreatitis) have been reported in patients receiving Efficib (see section 4).
Slovenian: Pri bolnikih, ki so prejemali zdravilo Efficib, so poročali o primerih vnetja trebušne slinavke (pankreatitisa) (glejte poglavje 4).
English: What Efficib contains
Slovenian: Kaj vsebuje zdravilo Efficib
English: For the different doses on metformin, Efficib is available in strengths of 50 mg sitagliptin and 850 mg metformin hydrochloride or 1,000 mg metformin hydrochloride.
Slovenian: Za različne odmerke metformina je zdravilo Efficib na voljo v jakostih po 50 mg sitagliptina in 850 mg metforminijevega klorida ali 1.000 mg metforminijevega klorida.
English: The level of digoxin in your blood may need to be checked if taking with Efficib.
Slovenian: Med sočasnim jemanjem z zdravilom Efficib vam bodo morda morali preveriti vrednosti digoksina v krvi.
English: Efficib is indicated as triple combination therapy with a peroxisome proliferator-activated receptor gamma (PPAR) agonist (i.e., a thiazolidinedione) as an adjunct to diet and exercise in patients inadequately controlled on their maximal tolerated dose of metformin and a PPAR agonist.
Slovenian: Zdravilo Efficib je indicirano za trojno kombinirano zdravljenje z agonistom receptorja gama, aktiviranega s peroksisomskim proliferatorjem (PPAR - peroxisome proliferator-activated receptor gamma) (tj. s tiazolidindionom) kot dodatek dieti in telesni aktivnosti pri bolnikih z neustrezno nadzorovano sladkorno boleznijo pri jemanju največjega odmerka metformina, ki ga prenašajo, in agonista PPAR.
English: Efficib is also indicated as add-on to insulin (i.e., triple combination therapy) as an adjunct to diet and exercise to improve glycaemic control in patients when stable dose of insulin and metformin alone do not provide adequate glycaemic control.
Slovenian: Zdravilo Efficib je indicirano tudi kot dodatno zdravljenje k insulinu (tj. trojno kombinirano zdravljenje) kot dodatek dieti in telesni aktivnosti za izboljšanje urejenosti glikemije pri bolnikih, pri katerih s stabilnim odmerkom insulina in samim metforminom urejenost glikemije ni zadostna.
English: If you are not sure, talk to your doctor, pharmacist or nurse before taking Efficib.
Slovenian: Če niste prepričani, se pred začetkom jemanja zdravila Efficib, posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
English: Do not take Efficib if any of the above apply to you and talk with your doctor about other ways of managing your diabetes.
Slovenian: Zdravila Efficib ne jemljite in se z zdravnikom posvetujte o drugih možnostih za nadzor sladkorne bolezni, če kar koli od navedenega velja za vas.
English: Talk to your doctor or pharmacist before taking Efficib: - if you have or have had a disease of the pancreas (such as pancreatitis) - if you have or have had gallstones, alcohol dependence or very high levels of triglycerides (a form of fat) in your blood.
Slovenian: Pred začetkom jemanja zdravila Efficib se posvetujte z zdravnikom ali farmacevtom: - če imate ali ste kdaj imeli bolezen trebušne slinavke (kot je pankreatitis).
English: Efficib is indicated in combination with a sulphonylurea (i.e., triple combination therapy) as an adjunct to diet and exercise in patients inadequately controlled on their maximal tolerated dose of metformin and a sulphonylurea.
Slovenian: Zdravilo Efficib je indicirano v kombinaciji s sulfonilsečnino (tj. trojno kombinirano zdravljenje) kot dodatek dieti in telesni aktivnosti pri bolnikih z neustrezno nadzorovano sladkorno boleznijo pri jemanju največjega odmerka metformina, ki ga prenašajo, in sulfonilsečnine.
English: Efficib 50 mg/1,000 mg film-coated tablets
Slovenian: Efficib 50 mg/1.000 mg filmsko obložene tablete
English: Efficib 50 mg/850 mg film-coated tablets
Slovenian: Efficib 50 mg/850 mg filmsko obložene tablete
English: EU/1/08/457/002 EU/1/08/457/003 EU/1/08/457/004 EU/1/08/457/005 EU/1/08/457/006 EU/1/08/457/007 EU/1/08/457/015 EU/1/08/457/017 EU/1/08/457/019 EU/1/08/457/020
Slovenian: EU/1/08/457/001 EU/1/08/457/002 EU/1/08/457/003 EU/1/08/457/004 EU/1/08/457/005 EU/1/08/457/006 EU/1/08/457/007 EU/1/08/457/015 EU/1/08/457/017 EU/1/08/457/019 EU/1/08/457/020
English: If pancreatitis is suspected, Efficib and other potentially suspect medicinal products should be discontinued; if acute pancreatitis is confirmed, Efficib should not be restarted.
Slovenian: V primeru potrjenega akutnega pankreatitisa se zdravila Efficib ne sme ponovno uvesti.
English: Tel: +34 93 291 30 00 info.spain@almirall.com
Slovenian: Tel: +34 93 291 30 00 comercial@almirall.es
English: How to store Efficib
Slovenian: Shranjevanje zdravila Efficib
English: If bullous pemphigoid is suspected, Efficib should be discontinued.
Slovenian: Ob sumu na bulozni pemfigoid je treba zdravljenje z zdravilom Efficib prekiniti.
English: EU/1/08/457/008 14 film-coated tablets EU/1/08/457/009 28 film-coated tablets EU/1/08/457/010 56 film-coated tablets EU/1/08/457/021 60 film-coated tablets EU/1/08/457/011 112 film-coated tablets EU/1/08/457/012 168 film-coated tablets EU/1/08/457/022 180 film-coated tablets EU/1/08/457/013 196 film-coated tablets EU/1/08/457/014 50 x 1 film-coated tablets EU/1/08/457/016 196 (2 x 98) film-coated tablets EU/1/08/457/018 168 (2 x 84) film-coated tablets
Slovenian: EU/1/08/457/008 14 filmsko obloženih tablet EU/1/08/457/009 28 filmsko obloženih tablet EU/1/08/457/010 56 filmsko obloženih tablet EU/1/08/457/021 60 filmsko obloženih tablet EU/1/08/457/011 112 filmsko obloženih tablet EU/1/08/457/012 168 filmsko obloženih tablet EU/1/08/457/022 180 filmsko obloženih tablet EU/1/08/457/013 196 filmsko obloženih tablet EU/1/08/457/014 50 x 1 filmsko obložena tableta EU/1/08/457/016 196 (2 x 98) filmsko obloženih tablet EU/1/08/457/018 168 (2 x 84) filmsko obloženih tablet
English: EU/1/08/457/009 EU/1/08/457/010 EU/1/08/457/011 EU/1/08/457/012 EU/1/08/457/013 EU/1/08/457/014 EU/1/08/457/016 EU/1/08/457/018 EU/1/08/457/021 EU/1/08/457/022
Slovenian: EU/1/08/457/008 EU/1/08/457/009 EU/1/08/457/010 EU/1/08/457/011 EU/1/08/457/012 EU/1/08/457/013 EU/1/08/457/014 EU/1/08/457/016
English: EU/1/08/457/001 14 film-coated tablets EU/1/08/457/002 28 film-coated tablets EU/1/08/457/003 56 film-coated tablets EU/1/08/457/019 60 film-coated tablets EU/1/08/457/004 112 film-coated tablets EU/1/08/457/005 168 film-coated tablets EU/1/08/457/020 180 film-coated tablets EU/1/08/457/006 196 film-coated tablets EU/1/08/457/007 50 x 1 film-coated tablets EU/1/08/457/015 196 (2 x 98) film-coated tablets EU/1/08/457/017 168 (2 x 84) film-coated tablets
Slovenian: EU/1/08/457/001 14 filmsko obloženih tablet EU/1/08/457/002 28 filmsko obloženih tablet EU/1/08/457/003 56 filmsko obloženih tablet EU/1/08/457/019 60 filmsko obloženih tablet EU/1/08/457/004 112 filmsko obloženih tablet EU/1/08/457/005 168 filmsko obloženih tablet EU/1/08/457/020 180 filmsko obloženih tablet EU/1/08/457/006 196 filmsko obloženih tablet EU/1/08/457/007 50 x 1 filmsko obložena tableta EU/1/08/457/015 196 (2 x 98) filmsko obloženih tablet EU/1/08/457/017 168 (2 x 84) filmsko obloženih tablet
English: Efficib 50 mg/850 mg tablets sitagliptin/metformin HCl
Slovenian: Efficib 50 mg/850 mg tablete sitagliptin/metformin HCl
English: Efficib 50 mg/1,000 mg tablets sitagliptin/metformin HCl
Slovenian: Efficib 50 mg/1.000 mg tablete sitagliptin/metformin HCl
English: Do not take Efficib: - if you are allergic to sitagliptin or metformin or any of the other ingredients of this medicine (listed in section 6) - if you have severely reduced kidney function - if you have uncontrolled diabetes, with e.g. severe hyperglycaemia (high blood glucose), nausea, vomiting, diarrhoea, rapid weight loss, lactic acidosis (see “Risk of lactic acidosis” below) or ketoacidosis.
Slovenian: - če imate nenadzorovano sladkorno bolezen, na primer s hudo hiperglikemijo (visoko ravnjo sladkorja v krvi), siljenjem na bruhanje, bruhanjem, drisko, hitro izgubo telesne mase, laktacidozo (glejte spodaj "Tveganje za laktacidozo") ali ketoacidozo.
English: In addition, patients should be alerted to the risk of hypoglycaemia when Efficib is used in combination with a sulphonylurea or with insulin.
Slovenian: Poleg tega je treba bolnike, ki jemljejo zdravilo Efficib skupaj s sulfonilsečnino ali z insulinom, opozoriti na tveganje za pojav hipoglikemije.
English: This is sometimes called insulin-dependent diabetes - if you have or have had an allergic reaction to sitagliptin, metformin, or Efficib (see section 4) - if you are taking a sulphonylurea or insulin, diabetes medicines, together with Efficib, as you may experience low blood sugar levels (hypoglycaemia).
Slovenian: - če imate ali ste imeli alergijsko reakcijo na sitagliptin, metformin ali zdravilo Efficib (glejte poglavje 4).
English: Efficib 50 mg/1,000 mg film-coated tablets sitagliptin/metformin hydrochloride
Slovenian: Efficib 50 mg/1.000 mg filmsko obložene tablete sitagliptin/metforminijev klorid
English: Efficib 50 mg/850 mg film-coated tablets sitagliptin/metformin hydrochloride
Slovenian: Efficib 50 mg/850 mg filmsko obložene tablete sitagliptin/metforminijev klorid
English: Efficib combines two antihyperglycaemic medicinal products with complementary mechanisms of action to improve glycaemic control in patients with type 2 diabetes: sitagliptin phosphate, a dipeptidyl peptidase 4 (DPP-4) inhibitor, and metformin hydrochloride, a member of the biguanide class.
Slovenian: Vsebuje sitagliptinijev fosfat, ki je zaviralec dipeptidil-peptidaze 4 (DPP-4), in metforminijev klorid, ki spada med bigvanide.
English: Some patients have experienced the following side effects during clinical studies while taking sitagliptin alone (one of the medicines in Efficib) or during post-approval use of Efficib or sitagliptin alone or with other diabetes medicines:
Slovenian: Pri nekaterih bolnikih, ki so v kliničnih študijah jemali samo sitagliptin (eno od učinkovin v zdravilu Efficib) ali so v obdobju trženja jemali zdravilo Efficib ali sitagliptin, sam ali z drugimi zdravili za zdravljenje sladkorne bolezni, so se pojavili naslednji neželeni učinki: Pogosti: nizek krvni sladkor, glavobol, okužba zgornjih dihal, zamašen nos ali izcedek iz nosu in vnetje grla, osteoartritis, bolečine v rokah ali nogah Občasni: omotica, zaprtje, srbenje
English: Overall summary of the scientific evaluation of Tibocina and associated names (see Annex I)
Slovenian: Splošni povzetek znanstvenega vrednotenja zdravila Tibocina in povezanih imen (glejte Prilogo I)
English: Such decisions should instead be taken on a case by case basis, following an evaluation of the findings and their potential impact.
Slovenian: Take odločitve je treba sprejemati na podlagi posameznih primerov po vrednotenju ugotovitev in njihovega morebitnega vpliva.
English: Tibolone is a synthetic steroid hormone drug which acts as an agonist, mainly on oestrogen receptors.
Slovenian: Tibolon je sintetično steroidno hormonsko zdravilo, ki deluje kot agonist, predvsem na estrogenske receptorje.
English: These findings were classified as critical and one of the concerned member states therefore considered it impossible to conclude on the reliability of the bioequivalence study.
Slovenian: Te ugotovitve so bile razvrščene kot kritične, zato je ena od zadevnih držav članic menila, da je nemogoče sklepati o zanesljivosti študije biološke enakovrednosti.
English: A referral under Article 29(4) of Directive 2001/83/EC was triggered and the CHMP was requested to give its opinion on whether the proposed products Tibolona Aristo and Tibocina can be considered bioequivalent to the reference product.
Slovenian: Skladno s členom 29(4) Direktive 2001/83/ES je bil sprožen napotitveni postopek, ki je od odbora CHMP zahteval, da poda mnenje o tem, ali se lahko zdravili Tibolona Aristo in Tibocina obravnavata kot biološko enakovredni referenčnemu zdravilu.
English: Having reviewed the available data, the CHMP considered that there was sufficient additional evidence indicating that the study samples were not put at risks during the study and that these were maintained under adequate temperature conditions.
Slovenian: Po pregledu razpoložljivih podatkov je odbor CHMP sklenil, da je dovolj dodatnih dokazov, ki kažejo, da preiskovani vzorci med študijo niso bili izpostavljeni tveganjem in da so bili shranjeni pri ustreznih temperaturnih pogojih.
English: The CHMP therefore reviewed the additional clinical evidence available, including the assessment carried out during the CMDh procedure and the evidence submitted by the Applicant.
Slovenian: Odbor CHMP je zato pregledal dodatne razpoložljive klinične dokaze, vključno z oceno, opravljeno med postopkom CMDh, in dokazi, ki jih je predložil predlagatelj.
English: Two applications under the decentralised procedure were submitted for the generic products Tibolona Aristo and Tibocina, both 2.5 mg tablets with the indication “treatment of oestrogen deficiency symptoms in women, more than one year after the menopause”.
Slovenian: Za generični zdravili Tibolona Aristo in Tibocina, 2,5 mg tablete, z indikacijo „zdravljenje simptomov pomanjkanja estrogena pri ženskah več kot leto po menopavzi“, sta bili predloženi dve vlogi v okviru decentraliziranega postopka.
English: In addition, the bioequivalence study conducted demonstrated bioequivalence, with observed drug concentrations being comparable or superior to those reported in the literature and the CHMP considered that these results suggest that no significant degree of drug degradation occurred.
Slovenian: Poleg tega je opravljena študija biološke enakovrednosti pokazala biološko enakovrednost, pri čemer so bile opažene koncentracije zdravila primerljive ali boljše od koncentracij, o katerih poroča literatura, zato je odbor CHMP menil, da ti rezultati niso pokazali pomembne stopnje degradacije zdravila.
English: • the CHMP reviewed the available data, including the Rapporteurs' assessment reports and the explanations submitted by the Applicant during the CMDh procedure
Slovenian: • odbor CHMP je pregledal razpoložljive podatke, vključno s poročili o oceni zdravila, ki so jih pripravili poročevalci, in razlagami, ki jih je med postopkom CMDh predložil predlagatelj;
English: During the assessment of the application dossiers, a Good Clinical Practice (GCP) inspection of the clinical site identified a lack of evidence documenting the transfer date and time and the identification of pharmacokinetic samples from the dry ice box used for flash freezing to the freezer used at this site until the samples were transferred to the bioanalytical site.
Slovenian: Med vrednotenjem dosjejev z vlogama je pregled dobre klinične prakse (DKP) v kliničnem centru pokazal pomanjkanje dokazov o identifikaciji farmakokinetičnih vzorcev in dokumentiranju datuma in časa njihovega prenosa iz škatle s suhim ledom, uporabljene za hitro zamrzovanje, v zamrzovalnik, uporabljen v tem centru, do prenosa vzorcev v bioanalitični center.
English: The CHMP acknowledged that the findings are considered as a critical deficiency, however it did not consider that GCP inspection findings classified as critical should automatically invalidate the results of a bioequivalence study.
Slovenian: Odbor CHMP je potrdil, da pri ugotovitvah obstajajo kritične pomanjkljivosti, vendar je menil, da ugotovitve pregleda DKP, razvrščene kot kritične, ne bi smele samodejno razveljaviti rezultatov študije biološke enakovrednosti.
English: A single bioequivalence study was conducted to support both applications.
Slovenian: Podprti sta bili samo z eno študijo biološke enakovrednosti.
English: The CHMP therefore concluded that while deviations from GCP requirements were identified, the totality of the available evidence confirms that the results of the bioequivalence study are reliable and demonstrates the bioequivalence of the proposed products and the reference product.
Slovenian: Odbor CHMP je zaključi, da so celotni razpoložljivi dokazi kljub odstopanju od zahtev DKP potrdili zanesljivost rezultatov študije biološke enakovrednosti in pokazali biološko enakovrednost zadevnih zdravil ter referenčnega zdravila.
English: Whereas
Slovenian: Nemčija
English: • the CHMP considered that the available data confirms that the results of the bioequivalence study are reliable and demonstrate the bioequivalence of the proposed products and the reference product the CHMP has recommended the granting of the marketing authorisations for which the summary of product characteristics, labelling and package leaflet remain as per the final versions achieved during the Coordination group procedure as mentioned in Annex III for Tibocina and associated names (see Annex I).
Slovenian: je odbor CHMP priporočil odobritev dovoljenj za promet z zdravili, za katera povzetek glavnih značilnosti zdravila, označevanje in navodilo za uporabo ostajajo enaki kot zadnje različice, pripravljene med postopkom usklajevalne skupine, kot je navedeno v Prilogi III za zdravilo Tibocina in povezana imena (glejte Prilogo I).
English: All symptoms resolved completely within a few hours.
Slovenian: Vsi simptomi so popolnoma izginili v nekaj urah.
English: • Allergic reactions which can, rarely, be serious
Slovenian: • alergijske reakcije, ki so lahko redko resne,
English: Women must be provided with comprehensive information on pregnancy prevention.
Slovenian: Ženskam je treba dati izčrpne informacije o preprečevanju nosečnosti.
English: Careful monitoring.
Slovenian: Skrbno spremljanje.
English: Response rates varied between 43 and 80% depending on the studies and the criteria to define a response.
Slovenian: Delež odziva je bil med 43 in 80 %, kar je bilo odvisno od študij in meril za opredelitev odziva.
English: Effects on human reproduction cannot be excluded.
Slovenian: Učinkov na razmnoževanje pri človeku ni mogoče izključiti.
English: Then go on with regular schedule as prescribed.
Slovenian: Potem nadaljujte z rednim razporedom, ki vam je bil predpisan.
English: In case of long term treatment (more than 6 months):
Slovenian: Pri dolgotrajnem zdravljenju (daljšem od 6 mesecev):
English: • Loss of appetite or increased appetite
Slovenian: • izguba apetita ali povečan apetit,
English: An ECG should be performed:
Slovenian: EKG je treba opraviti:
English: About 200 patients were treated for more than 6 months and some of them were treated for several years.
Slovenian: Približno 200 bolnikov so zdravili več kot 6 mesecev, nekatere izmed njih pa več let.
English: In a retrospective study conducted in several French centres, 200 patients with Cushing's disease were followed between 1995 and 2012.
Slovenian: V retrospektivni študiji, opravljeni v več francoskih ustanovah, so med letoma 1995 in 2012 spremljali 200 bolnikov s Cushingovo boleznijo.
English: Side effects with frequency not known (frequency cannot be estimated from the available data):
Slovenian: Neželeni učinki z neznano pogostnostjo (pogostnosti ni mogoče oceniti iz razpoložljivih podatkov):