FrancophonIA/ELRC3.0 huggingface dataset:
English: Raplixa is applied onto the surgical bleeding site directly from the vial or using the Raplixa spray delivery device, or onto a moistened gelatin sponge that is then applied to the surgical bleeding site.
Slovenian: Zdravilo Raplixa se nanese na kirurško mesto krvavitve neposredno iz viale, s pripomočkom RaplixaSpray ali na navlaženo želatinsko gobico, ki se nato nanese na kirurško mesto krvavitve.
English: Raplixa and the device should be stored at controlled, ambient room temperature.
Slovenian: Zdravilo Raplixa in pršilnik shranjujte pri nadzorovani sobni temperaturi okolice.
English: As a consequence, intravascular pharmacokinetic studies were not performed in man. Fibrin Sealants/haemostatics are metabolised in the same way as endogenous fibrin by fibrinolysis and phagocytosis.
Slovenian: Fibrinska lepila/hemostatiki se presnavljajo na enak način kot endogeni fibrin - s fibrinolizo in fagocitozo.
English: The use of Raplixa is restricted to experienced surgeons.
Slovenian: Zdravilo Raplixa lahko uporabljajo le izkušeni kirurgi.
English: Clinical studies in the EU were done with the CE marked Spongostan gelatin sponge.
Slovenian: V EU so izvedli klinične študije z želatinsko gobico Spongostan z oznako CE. Krvavitev na ciljnem mestu je bila blaga ali zmerna.
English: When applying Raplixa using a spray device, a defined pressure within the range recommended by the spray device manufacturer is to be used.
Slovenian: Pri nanosu zdravila Raplixa je treba uporabljati definiran tlak v razponu, ki ga priporoča proizvajalec pršila.
English: Raplixa is a pre-mixed, blend of thrombin and fibrinogen supplied as a ready to use dry-powder fibrin sealant in a glass vial containing 0.5 g, 1 g or 2 g of Raplixa.
Slovenian: Zdravilo Raplixa je vnaprej zmešana mešanica trombina in fibrinogena, na voljo kot za uporabo pripravljeno fibrinsko lepilo v obliki suhega praška v stekleni viali, ki vsebuje 0,5 g, 1 g ali 2 g zdravila Raplixa.
English: Source
Slovenian: Vir
English: The RaplixaSpray device comes with the rigid nozzle attached, which can be easily removed and the flexible nozzle attached depending on the intended use and surgeon preference.
Slovenian: Pripomoček RaplixaSpray ima priključeno togo šobo, ki jo lahko odstranite in priključite gibljivo šobo, odvisno od namena uporabe in želja kirurga.
English: Spray application of Raplixa should only be done using the provided spray application accessories and the pressure should not exceed 1.5 bars (22 psi).
Slovenian: Aplikacija zdravila Raplixa s pršilnikom je dovoljena le s priloženimi pripomočki za pršenje, tlak pa ne sme preseči 1,5 bara (22 psi).
English: Excipients: Trehalose, Calcium chloride, Human Albumin, Sodium chloride, Sodium citrate, L-arginine-hydrochloride
Slovenian: Pomožne snovi: trehaloza, kalcijev klorid, humani albumin, natrijev klorid, natrijev citrat, L-arginin hidroklorid prašek za lepilo za tkiva 1 viala 0,5 g 1 viala 1 g
English: Gelatin sponges must be used in combination with Raplixa.
Slovenian: V kombinaciji z zdravilom Raplixa je treba uporabljati želatinske gobice.
English: The RaplixaSpray device is used to spray the powder on to the bleeding site and then the gelatin sponge is applied (see Instructions For Use for RaplixaSpray device and gelatin sponge).
Slovenian: Pripomoček RaplixaSpray se uporablja za pršenje praška na mesto krvavitve, nato pa se uporabi želatinska gobica (glejte navodilo za uporabo pripomočka RaplixaSpray in želatinske gobice).
English: Connect the RaplixaSpray device to the RaplixaReg pressure regulator and thereby to the medical CO2 gas supply (CO2 is recommended; Raplixa may be also used with medical grade air) set to a pressure setting of 1.5 bar (22 psi).
Slovenian: Pripomoček RaplixaSpray je treba povezati z regulatorjem tlaka RaplixaReg in s tem na dovajanje medicinskega plina CO2 (CO2 se priporoča; zdravilo Raplixa se lahko uporablja tudi z medicinskim zrakom), nastavljenim na tlak 1,5 bara (22 psi).
English: The vial and Raplixa spray device should be taken out of their respective pouches maintaining sterility.
Slovenian: Vialo in pršilo RaplixaSpray je treba vzeti iz vrečk in ohraniti sterilnost.
English: - if you are allergic to human fibrinogen, human thrombin or any of the other ingredients of this medicine (listed in section 6)
Slovenian: Ne uporabljajte zdravila Raplixa: - če ste alergični na humani fibrinogen, humani trombin ali katerko koli sestavino tega zdravila
English: Sodium chloride Sodium citrate L-arginine-hydrochloride
Slovenian: 6.1 Seznam pomožnih snovi trehaloza kalcijev klorid albumin natrijev klorid natrijev citrat L-arginin hidroklorid
English: Spray application using RaplixaSpray device followed by gelatin sponge The vial and RaplixaSpray device are taken out of their respective pouches maintaining sterility.
Slovenian: Aplikacija s pršilom z uporabo pripomočka RaplixaSpray, ki mu sledi uporaba želatinske gobice Vialo in pripomoček RaplixaSpray je treba vzeti iz vrečk in ohraniti sterilnost.
English: The vial should be held upright, shaken gently and the aluminium cap and rubber stopper should be removed.
Slovenian: Vialo je treba držati pokonci, nežno pretresti in odstraniti aluminijasto zaporko in gumijasti zamašek.
English: Powder is applied directly from the vial onto the bleeding surface and then applied to a CE marked gelatin sponge cut to the appropriate size and apply manual pressure with sterile gauze.
Slovenian: Prašek se nanese neposredno iz viale na površino krvavitve, nato pa se nanjo položi želatinsko gobico z oznako CE, razrezano na ustrezne velike dele, na katere se z roko pritisne sterilna gaza.
English: Hold the vial upright, shake gently and remove the aluminium cap and rubber stopper.
Slovenian: Vialo držite pokonci, nežno jo pretresite in odstranite aluminijasto zaporko in gumijasti zamašek.
English: Connect the RaplixaSpray device to the RaplixaReg air pressure regulator or CO2 pressure regulator and thereby to the medical air or CO2 gas supply set to a pressure setting of 1.5 bar (22 psi).
Slovenian: Pršilo zdravila Raplixa povežite z regulatorjem zračnega tlaka RaplixaReg ali z regulatorjem tlaka CO2 in s tem z dovajanjem medicinskega zraka ali CO2, nastavljenim na tlak 1,5 bara (22 psi).
English: Calcium ions are required for both, the conversion of fibrinogen and the crosslinkage of fibrin.
Slovenian: Za obe reakciji, pretvorbo fibrinogena v fibrin in navzkrižno povezovanje fibrina, so potrebni kalcijevi ioni.
English: Direct application followed by gelatin sponge
Slovenian: Neposredni nanos, ki mu sledi želatinska gobica
English: Raplixa must not be applied intravascularly.
Slovenian: Zdravila Raplixa se ne sme dajati intravaskularno.
English: Sealant powder Dry white powder.
Slovenian: prašek za lepilo za tkiva suh bel prašek
English: What Raplixa looks like and contents of the pack Raplixa is a ready to use, pre-mixed, sterile, white dry powder supplied in a vial containing either 0.5 g, 1 g or 2 g.
Slovenian: Zdravilo Raplixa je za uporabo pripravljen, zmešan, sterilni, beli suhi prašek v viali, ki vsebuje 0,5 g, 1 g ali 2 g.
English: Raplixa sealant powder Human fibrinogen/Human thrombin
Slovenian: Raplixa prašek za lepilo za tkiva humani fibrinogen/human trombin
English: Any unused product should be discarded in accordance with local requirements.
Slovenian: Neuporabljeno zdravilo zavrzite v skladu z lokalnimi predpisi.
English: - as a glue for the fixation of patches - as a glue for intestines (gastrointestinal anastomoses) - on severe arterial bleeds
Slovenian: - neposredno v krvno žilo - pri endoskopskih posegih (posegih, pri katerih se za ogled notranjih organov uporablja endoskop) ali pri laparoskopskih posegih - kot lepilo za pritrditev obližev - kot lepilo za črevesje (gastrointestinalna anastomoze) - pri hudih krvavitvah iz arterije
English: The spray device and the accessory nozzle are provided with instructions for use, which should be carefully followed.
Slovenian: Pršilniku in šobi je priloženo navodilo za uporabo s priporočili za razpon tlaka in bližino do površine tkiva, kar je treba natančno upoštevati.
English: When spraying Raplixa, changes in blood pressure, pulse, oxygen saturation and end tidal CO2 should be monitored because of the possibility of occurrence of air or gas embolism.
Slovenian: Pri pršenju zdravila Raplixa je treba spremljati spremembe krvnega tlaka, utripa, saturacijo s kisikom in CO2 na koncu izdiha, saj se lahko pojavi zračna ali plinska embolija.
English: • The Summary of Product Characteristics (SmPC)
Slovenian: • povzetek glavnih značilnosti zdravila
English: Despite this, when medicinal products prepared from human blood or plasma are administered, the possibility of transmitting infective agents cannot be totally excluded.
Slovenian: Kljub temu pri uporabi zdravil, pripravljenih iz humane krvi ali plazme, ni možno povsem izključiti možnosti prenosa povzročiteljev nalezljivih bolezni, tudi tistih, ki do danes še niso poznani, porajajočih se virusov
English: The vial with powder is attached to the RaplixaSpray device by inverting the device over the upright vial and pushing the vial into place.
Slovenian: Vialo s praškom je treba pritrditi na pripomoček RaplixaSpray tako, da se pripomoček obrne na glavo čez vialo, ki stoji navpik, in vstavi v vialo.
English: The RaplixaSpray device comes with the rigid nozzle attached.
Slovenian: Pripomoček RaplixaSpray ima priključeno togo šobo.
English: - The third method is application of Raplixa onto the bleeding site using the recommended spray device followed by the application of the gelatin sponge.
Slovenian: Tretja metoda je nanos zdravila Raplixa na mesto krvavitve s priporočenim pršilnikom, ki mu sledi nanos želatinske gobice.
English: Recommended spray pressure
Slovenian: Priporočeni tlak pršenja odprta metoda operacije
English: Life-threatening events have occurred with the use of other spray devices employing a pressure regulator to administer other fibrin sealants.
Slovenian: Pri uporabi drugih pršilnikov, ki uporabljajo regulator tlaka, za nanos fibrinskih lepil, je prišlo do življenjsko nevarnih dogodkov.
English: The Raplixa spray device is connected to the RaplixaReg pressure regulator and thereby to the medical gas supply set to a pressure setting of 1.5 bar (22 psi).
Slovenian: Pripomoček RaplixaSpray se poveže z regulatorjem tlaka RaplixaReg in s tem z dovajanjem medicinskega zraka, nastavljenim na tlak 1,5 bara (22 psi).
English: Spray application using Raplixa spray device followed by gelatin sponge Use Raplixa with the Raplixa spray device.
Slovenian: Nanos s pršilom z uporabo pripomočka RaplixaSpray, ki mu sledi uporaba želatinske gobice Zdravilo Raplixa se lahko uporablja s pripomočkom RaplixaSpray.
English: 1 vial 0.5 g 1 vial 1 g 1 vial 2 g
Slovenian: 1 viala 2 g
English: Connect the vial to the device by inverting the device over the upright vial and pushing the vial into place.
Slovenian: Vialo pritrdite na pršilo tako, da pripomoček poveznete čez vialo, ki stoji navpik, in vstavite vialo.
English: Take the vial and device out of their respective pouches maintaining sterility.
Slovenian: Vialo in pršilo RaplixaSpray vzemite iz vrečk in ohranite sterilnost.
English: There is limited experience of use of Raplixa in vascular surgery when applied with the RaplixaSpray device.
Slovenian: Z uporabo zdravila Raplixa pri posegih na žilju so izkušnje omejene, če se zdravilo Raplixa uporablja s pripomočkom RaplixaSpray.
English: • Requirement to closely monitor blood pressure, pulse rate, oxygen saturation, and end tidal CO2
Slovenian: • zahtevano je, da je treba natančno spremljati spremembe v krvnem tlaku, pulzu, saturaciji s kisikom ter CO2 v izdihanem zraku ob koncu izdiha zaradi možnosti za pojav plinske embolije
English: Maximum Surface Area Application Using RaplixaSpray
Slovenian: Največja površina nanosa Nanos z uporabo pripomočka RaplixaSpray
English: Fertility Fertility studies have not been conducted.
Slovenian: Posledično intravaskularnih farmakokinetičnih študij pri ljudeh niso izvajali.
English: Powder is applied directly from the vial onto a saline-wetted CE marked gelatin sponge and then applied to the bleeding site.
Slovenian: Prašek se aplicira neposredno iz viale na želatinsko gobico z oznako CE, namočeno v fiziološko raztopino, nato pa se nanese na mesto krvavitve.
English: When Raplixa is applied directly to the surgical bleeding site, a thin layer should be used to cover the bleeding/oozing area completely.
Slovenian: Pri nanosu zdravila Raplixa neposredno na kirurško mesto, ki krvavi, je treba uporabiti tanek sloj, ki povsem prekrije predel, ki krvavi/iz katerega se izceja.
English: • Itch
Slovenian: • srbenje
English: Life threatening thromboembolic complications may occur if the preparation is unintentionally applied intravascularly.
Slovenian: Če se zdravilo nenamerno uporabi intravaskularno, se lahko pojavijo življenjsko nevarni trombembolični zapleti.
English: Presentation
Slovenian: Odmerjanje
English: 6.6 Instructions for use and handling and special precautions for disposal
Slovenian: 6.6 Posebni varnostni ukrepi za odstranjevanje in ravnanje z zdravilom
English: • Raplixa will be applied as a thin layer.
Slovenian: • Zdravilo Raplixa se nanese v tanki plasti.
English: sealant powder
Slovenian: Nalepka viale
English: Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system.
Slovenian: Od zdravstvenih delavcev se zahteva, da poročajo o katerem koli domnevnem neželenem učinku zdravila na Univerzitetni klinični center Ljubljana, Interna klinika Center za zastrupitve
English: - Application of Raplixa straight from the vial to the bleeding site followed by the application of the gelatin sponge.
Slovenian: Zdravilo Raplixa se lahko nanese na mesto krvavitve neposredno iz viale, nato pa sledi nanos želatinske gobice.
English: Life threatening air or gas embolism has occurred with the use of spray devices employing a pressure regulator to administer fibrin sealant/haemostatic products.
Slovenian: Pri uporabi drugih pršil, ki uporabljajo regulator tlaka, za nanos fibrinskih lepil/hemostatskih zdravil, je prišlo do življenjsko nevarne zračne ali plinske embolije.
English: Method and route of administration
Slovenian: Odmerjanje in način uporabe
English: Do not use Raplixa if the seal on the vial has been tampered with.
Slovenian: Zdravila Raplixa ne uporabljajte, če opazite poškodbe tesnilnega zamaška ali viale.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING ALUMINIUM-BONDED FOIL SACHET
Slovenian: VREČKA IZ ALUMINIJASTE FOLIJE
English: You can also report side effects directly via the national reporting system.
Slovenian: O neželenih učinkih lahko poročate tudi neposredno na Univerzitetni klinični center Ljubljana, Interna klinika Center za zastrupitve
English: Apply first to gelatin sponge
Slovenian: Nanos na želatinsko gobico
English: PHARMACEUTICAL FORM AND CONTENTS
Slovenian: Izgled zdravila Raplixa in vsebina pakiranja
English: - Application from the vial onto a wetted gelatin sponge and then applied to the bleeding site.
Slovenian: Drugi način je nanos iz viale na omočeno želatinsko gobico in nato na mesto krvavitve.
English: Raplixa sealant powder
Slovenian: Raplixa prašek za lepilo za tkiva
English: Date of first authorisation: 24 April 2012 Date of latest renewal: 18 November 2016
Slovenian: Datum prve odobritve: 24. april 2012 Datum zadnjega podaljšanja: 18. november 2016
English: Treatment should not be restarted.
Slovenian: Zdravljenja se ne sme ponovno uvesti.
English: What do I need
Slovenian: Kaj potrebujete
English: Elderly patients (≥65 years)
Slovenian: Starejši bolniki (≥65 let)
English: The dose may be decreased either temporarily or permanently.
Slovenian: Odmerek je mogoče znižati bodisi začasno ali trajno.
English: Linearity and time dependency
Slovenian: Linearnost in časovna odvisnost
English: (figure B).
Slovenian: (slika B).
English: Please follow their instructions.
Slovenian: Držite se njunih navodil.
English: 192 patients were treated.
Slovenian: Zdravili so 192 bolnikov.
English: Normalisation of IGF-1
Slovenian: normalizacija IGF-1
English: The study enrolled 150 patients.
Slovenian: V študijo so vključili 150 bolnikov.
English: The safety and efficacy of Signifor in children and adolescents aged 0 to 18 years have not been established.
Slovenian: Varnost in učinkovitost zdravila Signifor pri otrocih in mladostnikih, starih od 0 do 18 let, nista bili dokazani.
English: - If you are a sexually active woman, you should use an effective method of contraception during treatment.
Slovenian: - Če ste spolno aktivna ženska, morate med zdravljenjem uporabljati učinkovito metodo kontracepcije.
English: If this happens, tell your doctor immediately.
Slovenian: Če pride do navedenega, takoj obvestite zdravnika.
English: The clinical significance of this prolongation is unknown.
Slovenian: Klinični pomen tega podaljšanja ni znan.
English: Cushing's disease
Slovenian: Cushingova bolezen
English: Based on the local clinical practice, your doctor or nurse will tell you which method to use.
Slovenian: Glede na lokalno klinično prakso vam bosta vaš zdravnik ali medicinska sestra povedala, katero metodo boste uporabljali.
English: - Take the ampoule out of the box.
Slovenian: - Ampulo vzemite iz škatle.
English: Similar results were also seen at month 12.
Slovenian: Podobne rezultate so opažali tudi po 12 mesecih.
English: You should also read the instructions at the end of this leaflet.
Slovenian: Prebrati morate tudi navodila na koncu tega navodila za uporabo.
English: Pasireotide did not affect insulin sensitivity.
Slovenian: Pasireotid ni vplival na občutljivost za insulin.
English: Do not give this medicine to children and adolescents below 18 years old because no data are available in this age group.
Slovenian: Zdravila ne smete dajati otrokom in mladostnikom pred 18 letom starosti, ker za to starostno skupino ni na voljo nobenih podatkov.
English: Table 3 Key results at week 24 (Study C2402)
Slovenian: Preglednica 3 Glavni rezultati po 24 tednih (študija C2402)
English: Do not let the needle touch anything.
Slovenian: Pazite, da se z iglo ničesar ne dotaknete.
English: - You should not use Signifor during pregnancy unless clearly necessary.
Slovenian: - Med nosečnostjo ne smete uporabljati zdravila Signifor, razen če je to nedvomno potrebno.
English: Signifor may affect the way some other medicines work.
Slovenian: Zdravilo Signifor lahko vpliva na delovanje nekaterih drugih zdravil.
English: The incidence of such events was highest in the first 3 months of treatment.
Slovenian: Pogostnost takih dogodkov je bila največja v prvih 3 mesecih zdravljenja.
English: Your doctor will regularly monitor your condition to check that the treatment is having the desired effect.
Slovenian: Zdravnik bo redno spremljal vaše stanje in preverjal, ali zdravljenje dosega želene učinke.
English: Do not use Signifor - if you are allergic to pasireotide or any of the other ingredients of this medicine (listed in section 6).
Slovenian: Ne uporabljajte zdravila Signifor - če ste alergični na pasireotid ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
English: Long-term follow-up data are not available.
Slovenian: Podatki dolgoročnega spremljanja bolnikov niso na voljo.
English: After the initial 6 months in the study, patients entered an additional 6-month open-label treatment period.
Slovenian: Po prvih 6 mesecih študije so bolniki vstopili v dodatno 6-mesečno obdobje odprtega zdravljenja.
English: Other side effects of Signifor may include:
Slovenian: Drugi neželeni učinki zdravila Signifor lahko vključujejo:
English: The clinical relevance of these effects in humans is unknown.
Slovenian: Klinična pomembnost teh učinkov pri ljudeh ni znana.
English: ULN = upper limit of normal
Slovenian: ZMN = zgornja meja normalnih vrednosti
English: A total of 358 patients were randomised and treated.
Slovenian: Skupno so randomizirali in zdravili 358 bolnikov.
English: - Inspect the ampoule.
Slovenian: - Ampulo preglejte.
English: Gallbladder and related events
Slovenian: Žolčnik in z njim povezani dogodki
English: In both these cases, return the entire pack to the pharmacy.
Slovenian: V obeh primerih vrnite celotno pakiranje v lekarno.
English: When you are ready to give yourself the injection, carefully follow the steps below: - Wash your hands thoroughly with soap and water.
Slovenian: Ko boste pripravljeni, da si injicirate zdravilo, previdno postopajte po naslednjih korakih: - Temeljito si umijte roke z milom in vodo.
English: Frequencies were defined as follows: Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100).
Slovenian: Kategorije pogostnosti so opredeljene takole: zelo pogosti (≥1/10); pogosti (≥1/100 do <1/10); občasni (≥1/1.000 do <1/100).
English: The improvement observed up to week 24 between the treatment groups was also not statistically significant.
Slovenian: Tudi razlika v obsegu izboljšanja do konca 24. tedna med študijskimi skupinami ni dosegla statistične značilnosti.
English: It is used to treat acromegaly in adult patients.
Slovenian: Uporabljamo ga za zdravljenje akromegalije pri odraslih bolnikih.
English: N=65 n (%), p value
Slovenian: N=65 n (%), vrednost p
English: Cushing's disease study G2304
Slovenian: Študija Cushingove bolezni z oznako G2304
English: Extension phase
Slovenian: Faza podaljšanja
English: Plasma protein binding is moderate (88%) and independent of concentration.
Slovenian: Vezava na proteine v plazmi je zmerna (88 %) in ni odvisna od koncentracije.
English: All QT-related events were transient and resolved without therapeutic intervention.
Slovenian: Vsi z intervalom QT povezani dogodki so bili prehodni in so izzveneli brez terapevtskih ukrepov.
English: Multipack containing 3 intermediate cartons
Slovenian: skupno pakiranje, ki vsebuje 3 vmesne škatle
English: Once the ampoule is open, put it upright on a clean, flat surface.
Slovenian: Ko je ampula odprta, jo postavite pokončno na čisto, ravno površino.
English: In all these cases, return the entire pack to the pharmacy.
Slovenian: V vseh navedenih primerih vrnite celotno pakiranje v lekarno.
English: Similar trends were observed at month 12.
Slovenian: Podoben trend so opažali tudi po 12 mesecih.
English: Five human somatostatin receptor subtypes are known: hsst1, 2, 3, 4, and 5.
Slovenian: Pri človeku je znanih pet podvrst receptorjev za somatostatin: hsst1, 2, 3, 4 in 5.
English: Distribution between blood cells and plasma is concentration independent and shows that pasireotide is primarily located in the plasma (91%).
Slovenian: Porazdelitev med krvnimi celicami in plazmo ni odvisna od koncentracije zdravila in kaže, da se pasireotid porazdeli predvsem v plazmi (91 %).
English: - if you have severe liver problems.
Slovenian: - če imate hudo okvaro jeter.
English: Patients uncontrolled at both month 1 and month 2 are likely (90%) to remain uncontrolled at months 6 and 12.
Slovenian: Bolniki, ki so bili tako po 1. kot po 2. mesecu neurejeni, so z veliko verjetnostjo (v 90 %) ostali neurejeni tudi po 6 in 12 mesecih.
English: If you see blood in the syringe, first remove the needle from the skin, then replace the short needle with a new one and insert it into a different injection site.
Slovenian: Če pri tem opazite kri v brizgi, najprej izvlecite iglo iz kože, nato zamenjajte kratko iglo z novo in jo zabodite na drugem mestu injiciranja.
English: This may involve measuring the levels of growth hormone or other hormones in your blood.
Slovenian: To lahko vključuje merjenje ravni rastnega hormona ali drugih hormonov v krvi.
English: * Grouped terms: Adrenal insufficiency includes adrenal insufficiency and blood cortisol decreased.
Slovenian: * Skupni izrazi: Adrenalna insuficienca vključuje adrenalno insuficienco in znižano vrednost kortizola v krvi.
English: Your doctor will check regularly how you respond to the treatment with Signifor and determine which dose is best for you.
Slovenian: Zdravnik bo redno preverjal vaš odziv na zdravljenje z zdravilom Signifor in določal, kateri odmerek je za vas najbolj primeren.
English: Additional dose adjustments (up to a maximum of 40 mg) were allowed at months 7 and 9 of the core phase.
Slovenian: Nadaljnje prilagajanje odmerka (do največ 40 mg) je bilo dovoljeno po 7 in 9 mesecih osnovne faze študije.