FrancophonIA/ELRC3.0 huggingface dataset:
English: In acromegaly patients elevated fasting glucose level was the most frequently reported grade 3/4 laboratory abnormality in the two phase III studies.
Slovenian: Pri bolnikih z akromegalijo so izmed patoloških laboratorijskih izvidov stopnje 3/4 v dveh študijah faze III največkrat poročali o zvišani vrednosti glukoze v krvi na tešče.
English: Your doctor or nurse will inject Signifor.
Slovenian: Zdravilo Signifor vam bo injiciral zdravnik ali medicinska sestra.
English: Studies in rats in which pasireotide was administered via the subcutaneous route have shown effects on female reproductive parameters (see section 5.3).
Slovenian: Študije na podganah, v katerih so pasireotid odmerjali subkutano, so pokazale vpliv na reproduktivne parametre samic (glejte poglavje 5.3).
English: QTcF >480 ms was reported for 3 versus 2 patients in the pasireotide intramuscular use and octreotide intramuscular use groups, respectively, and QTcF >60 ms prolonged from baseline was reported for 2 versus 1 patients in the respective groups.
Slovenian: O intervalu QTcF, daljšem od 480 ms so poročali pri 3 bolnikih iz skupine s pasireotidom za intramuskularno uporabo in pri 2 bolnikih iz skupine z oktreotidom za intramuskularno uporabo.
English: In study C2305, grade 3 elevated fasting glucose levels were reported in 9.7% and 0.6% and grade 4 in 0.6% and 0% of acromegaly patients treated with pasireotide intramuscular use and octreotide intramuscular use, respectively.
Slovenian: V študiji C2305 so o stopnji 3 zvišanja vrednosti glukoze v krvi na tešče poročali pri 9,7 % bolnikov z akromegalijo, ki so prejemali pasireotid za intramuskularno uporabo, in pri 0,6 % bolnikov, ki so prejemali oktreotid za intramuskularno uporabo.
English: Powder and solvent for suspension for injection
Slovenian: prašek in vehikel za suspenzijo za injiciranje
English: Decreased appetite, type 2 diabetes mellitus, glucose tolerance impaired
Slovenian: Presnovne in prehranske motnje hiperglikemija, sladkorna bolezen zmanjšan apetit, sladkorna bolezen tipa 2, motena toleranca za glukozo
English: Table 3 Percentage change in mean and median UFC levels per randomised dose group at month 6 and month 12 compared to baseline values
Slovenian: Preglednica 3 Odstotne spremembe povprečne in mediane vrednosti UFC pri obeh randomiziranih skupinah po 6 in 12 mesecih v primerjavi z izhodiščnimi vrednostmi pasireotid 0,6 mg dvakrat na dan odstotna sprememba (n)
English: <2.5 µg/l and normalisation of IGF-1 at the same time point was also comparable between the two treatment arms.
Slovenian: Odstotek bolnikov s povprečno koncentracijo rastnega hormona <2,5 µg/l in z normalizacijo vrednosti faktorja IGF-1 pri isti meritvi je bil primerljiv v obeh študijskih skupinah.
English: Diarrhoea, nausea, abdominal pain*
Slovenian: Bolezni prebavil diareja, navzea, bolečine v trebuhu*
English: - medicines to treat certain psychiatric disorders (chlorpromazine, thioridazine, fluphenazine, pimozide, haloperidol, tiapride, amisulpride, sertindole, methadone); - medicines to treat hay fever and other allergies (terfenadine, astemizole, mizolastine); - medicines used in the prevention or treatment of malaria (chloroquine, halofantrine, lumefantrine); - medicines to control blood pressure such as:
Slovenian: pimozid, haloperidol, tiaprid, amisulprid, sertindol, metadon); - zdravila za zdravljenje senenega nahoda in drugih alergij (terfenadin, astemizol, mizolastin); - zdravila za preprečevanje ali zdravljenje malarije (klorokin, halofantrin, lumefantrin); - zdravila za uravnavanje krvnega tlaka, kot so:
English: Monitoring of pituitary function (e.g. TSH/free T4, GH/IGF-1) before and periodically during Signifor therapy should therefore be considered, as clinically appropriate.
Slovenian: Iz tega razloga velja razmisliti o spremljanju delovanja hipofize (na primer o določanju vrednosti tirotropina (TSH)/prostega tiroksina (T4), rastnega hormona (GH)/insulinu podobnega rastnega faktorja-1 (IGF-1)), in sicer pred in občasno med zdravljenjem z zdravilom Signifor, v skladu s kliničnimi potrebami.
English: Non-clinical safety data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, toxicity to reproduction and development.
Slovenian: Predklinični podatki o varnosti na osnovi običajnih študij farmakološke varnosti, toksičnosti pri ponavljajočih odmerkih, genotoksičnosti, kancerogenega potenciala, vpliva na sposobnost razmnoževanja in razvoja ne kažejo posebnega tveganja za človeka.
English: Adverse reactions of hyperglycaemia and diabetes mellitus led to study discontinuation in 5 (3.1%) and 4 (2.5%) patients, respectively.
Slovenian: Zaradi hiperglikemije kot neželenega učinka je sodelovanje v študiji prekinilo 5 bolnikov (3,1 %), zaradi sladkorne bolezni kot neželenega učinka pa 4 bolniki (2,5 %).
English: Pasireotide administered via the subcutaneous route did not affect fertility in male rats but, as expected from the pharmacology of pasireotide, females presented abnormal cycles or acyclicity, and decreased numbers of corpora lutea and implantation sites.
Slovenian: Pasireotid, ki so ga odmerjali subkutano, ni vplival na plodnost samcev pri podganah, je pa pri samicah v skladu s farmakologijo pasireotida prišlo do nepravilnih ciklusov oziroma do njihove odsotnosti (do acikličnosti) in do zmanjšanega števila rumenih telesc ter nidacijskih mest.
English: Turn syringe and vial upside down, slowly pull the plunger back and draw the entire content from the vial into the syringe.
Slovenian: Počasi vlecite bat in potegnite celotno vsebino viale v brizgo.
English: Tartaric acid Sodium hydroxide Water for injections
Slovenian: 6.1 Seznam pomožnih snovi manitol vinska kislina natrijev hidroksid voda za injekcije
English: Musculoskeletal and connective tissue disorders
Slovenian: Bolezni mišičnoskeletnega sistema in vezivnega tkiva mialgija, artralgija
English: Very common (may affect more than 1 in 10 people) - Diarrhoea - Nausea - Abdominal pain - Fatigue
Slovenian: Zelo pogosti (lahko se pojavijo pri več kot 1 od 10 bolnikov) - driska - slabost - bolečine v trebuhu - utrujenost
English: Common (may affect up to 1 in 10 people) - Tiredness, fatigue, pale skin (signs of low level of red blood cells) - Loss of appetite - Headache - Bloating - Vomiting - Dizziness - Pain, discomfort, pruritis and swelling at the injection site - Change in liver function test results
Slovenian: Pogosti (lahko se pojavijo pri največ 1 od 10 bolnikov) - utrujenost, izčrpanost , bledica (znaki zmanjšanega števila rdečih krvnih celic) - izguba apetita - glavobol - napihnjenost trebuha - bruhanje - omotičnost - bolečina, neprijeten občutek, srbenje in oteklina na mestu injiciranja - nenormalni izvidi testov jetrne funkcije - nenormalni izvidi krvnih preiskav (kot so zvišane ravni kreatin-kinaze, glikiranega hemoglobina in lipaze v krvi) - izpadanje las
English: Bradycardic medicinal products
Slovenian: Zdravila, ki povzročajo bradikardijo
English: Treatment with Signifor leads to rapid suppression of ACTH (adrenocorticotropic hormone) secretion in Cushing's disease patients.
Slovenian: Pri bolnikih s Cushingovo boleznijo zdravljenje z zdravilom Signifor povzroči nenadno zmanjšanje sproščanja ACTH (adrenokortikotropnega hormona).
English: Available data in rats in which pasireotide was administered via the subcutaneous route have shown excretion of pasireotide in milk (see section 5.3).
Slovenian: Razpoložljivi podatki pri podganah, ki so jim pasireotid odmerjali subkutano, kažejo na izločanje pasireotida v mleko (glejte poglavje 5.3).
English: Pasireotide did not affect fertility in male rats but, as expected from the pharmacology of pasireotide, females presented abnormal cycles or acyclicity, and decreased numbers of corpora lutea and implantation sites.
Slovenian: Pasireotid ni vplival na plodnost samcev pri podganah, je pa pri samicah v skladu s farmakologijo pasireotida prišlo do nepravilnih ciklusov oziroma do njihove odsotnosti (do acikličnosti) in do zmanjšanega števila rumenih telesc ter nidacijskih mest.
English: Signifor 0.6 mg solution for injection EU/1/12/753/005-008
Slovenian: Signifor 0,6 mg raztopina za injiciranje EU/1/12/753/005-008
English: Signifor 0.3 mg solution for injection Signifor 0.6 mg solution for injection Signifor 0.9 mg solution for injection pasireotide
Slovenian: Signifor 0,3 mg raztopina za injiciranje Signifor 0,6 mg raztopina za injiciranje Signifor 0,9 mg raztopina za injiciranje pasireotid
English: Treatment of adult patients with Cushing's disease for whom surgery is not an option or for whom surgery has failed.
Slovenian: Zdravljenje tistih odraslih bolnikov s Cushingovo boleznijo, za katere kirurški poseg ni primeren oziroma pri katerih kirurški poseg ni bil uspešen.
English: Mean HbA1c increases were less pronounced in patients with normal glycaemia at study entry in comparison to pre-diabetic patients or diabetic patients.
Slovenian: Pri bolnikih, ki so imeli ob vstopu v študijo normalne vrednosti glukoze v krvi, je bilo povprečno zvišanje vrednosti HbA1c manj izrazito kot pri bolnikih s predstopnjo sladkorne bolezni ali sladkorno boleznijo.
English: The proportion of patients achieving biochemical control was 15.4% (p-value = 0.0006) and 20.0% (p-value <0.0001) for pasireotide intramuscular use 40 mg and 60 mg, respectively at 24 weeks compared with zero in the active control arm (Table 3).
Slovenian: Pri intramuskularni uporabi pasireotida v odmerku 40 mg oziroma 60 mg sta bila po 24 tednih deleža bolnikov, ki so dosegli urejenost biokemijskih parametrov, 15,4 % (vrednost p = 0,0006) in 20,0 % (vrednost p < 0,0001) v primerjavi z 0 % v skupini s primerjalnim zdravilom (preglednica 3).
English: Signifor 20 mg: each vial contains 20 mg pasireotide (as pasireotide pamoate).
Slovenian: Signifor 20 mg: ena viala vsebuje 20 mg pasireotida (v obliki pasireotidijevega pamoata).
English: Episodes of torsade de pointes were not observed in any clinical study with pasireotide.
Slovenian: V nobeni od kliničnih študij s pasireotidom niso opažali epizod torsade de pointes.
English: Signifor 0.9 mg solution for injection EU/1/12/753/009-0012
Slovenian: Signifor 0,9 mg raztopina za injiciranje EU/1/12/753/009-012
English: (hypoglycaemia); - heart problems such as a recent heart attack, congestive heart failure (a type of heart disease where the heart cannot pump enough blood around the body) or sudden and oppressive chest pain (usually felt as pressure, heaviness, tightening, squeezing or aching across the chest); - a heart rhythm disorder, such as an irregular heartbeat or an abnormal electrical signal called
Slovenian: Opozorila in previdnostni ukrepi Pred začetkom uporabe zdravila Signifor se posvetujte z zdravnikom, če imate ali ste imeli kdaj prej: - težave s koncentracijo sladkorja v krvi, bodisi s previsokimi vrednostmi (kot pri sladkorni bolezni) ali s prenizkimi vrednostmi (hipoglikemija); - težave s srcem, kot so nedavni srčni infarkt, kongestivno popuščanje srca (vrsta srčne bolezni, pri kateri srce ne more dovolj učinkovito črpati krvi po telesu) ali nenadna stiskajoča bolečina v prsnem košu (običajno kot občutek pritiska, teže, stiskanja, tiščanja ali bolečine znotraj prsnega koša); - motnje srčnega ritma, kot so nereden srčni utrip ali nenormalen signal električne aktivnosti srca ki mu pravimo “podaljšanje intervala QT” ali “podaljšanje QT”; - znižano koncentracijo kalija ali magnezija v krvi; - žolčne kamne.
English: Elevated glucose was the most frequently reported Grade 3 laboratory abnormality (23.2% of patients) in the phase III study in Cushing's disease patients.
Slovenian: V študiji faze III pri bolnikih s Cushingovo boleznijo so izmed patoloških laboratorijskih vrednosti 3. stopnje najbolj pogosto poročali o zvišani vrednosti glukoze (pri 23,2 % bolnikov).
English: Check the expiry date which is stated on the ampoule label (after “EXP”) and check that the ampoule contains the dose that your doctor has prescribed.
Slovenian: Poleg tega preverite, ali ampula vsebuje odmerek, ki vam ga je predpisal zdravnik.
English: Baseline mean GH was 17.6 µg/l, 12.1 µg/l and 9.5 µg/l, in the 40 mg, 60 mg and active control groups, respectively.
Slovenian: Povprečne izhodiščne koncentracije rastnega hormona v skupinah z odmerkom 40 mg, 60 mg oziroma s primerjalnim zdravilom so bile 17,6 µg/l, 12,1 µg/l oziroma 9,5 µg/l.
English: Clinical monitoring of heart rate, notably at the beginning of treatment, is recommended in patients receiving pasireotide concomitantly with bradycardic medicinal products, such as beta blockers (e.g. metoprolol, carteolol, propranolol, sotalol), acetylcholinesterase inhibitors (e.g. rivastigmine, physostigmine), certain calcium channel blockers (e.g. verapamil, diltiazem, bepridil), certain antiarrhythmics (see also section 4.4).
Slovenian: Pri bolnikih, ki prejemajo pasireotid sočasno z zdravili, ki povzročajo bradikardijo, kot so antagonisti adrenergičnih receptorjev beta (na primer metoprolol, karteolol, propranolol, sotalol), zaviralci acetilholinesteraze (rivastigmin, fizostigmin), določeni zaviralci kalcijevih kanalčkov (na primer verapamil, diltiazem, bepridil) in določeni antiaritmiki, je treba klinično spremljati frekvenco srčnega utripa, zlasti na začetku zdravljenja (glejte poglavje 4.4).
English: Very common (may affect more than 1 in 10 people) - High level of sugar in the blood.
Slovenian: Zelo pogosti (lahko se pojavijo pri več kot 1 od 10 bolnikov) - visoka raven sladkorja v krvi: lahko pride do prekomerne žeje, odvajanja velikih količin urina,
English: Signifor should be administered using sterile disposable syringes and injection needles.
Slovenian: Za odmerjanje zdravila Signifor je treba uporabljati sterilne injekcijske brizge in injekcijske igle za enkratno uporabo.
English: Remove the cap from the syringe pre-filled with solvent and screw the syringe onto the vial adapter.
Slovenian: Snemite pokrovček z brizge, v kateri je vehikel, in privijte brizgo na adapter za vialo.
English: Pasireotide may decrease the relative bioavailability of ciclosporin.
Slovenian: Predvidene farmakokinetične interakcije, ki bi lahko vplivale na druga zdravila Pasireotid lahko zmanjša relativno biološko uporabnost ciklosporina.
English: A total of 201 Cushing's disease patients received Signifor in phase II and III studies.
Slovenian: V študijah faze II in III je skupno 201 bolnik s Cushingovo boleznijo prejemal zdravilo Signifor.
English: What Signifor looks like and contents of the pack Signifor solution for injection is a clear, colourless solution in an ampoule.
Slovenian: Signifor raztopina za injiciranje je bistra in brezbarvna raztopina v ampuli.
English: Hyperglycaemia and, less frequently, hypoglycaemia, were observed in subjects participating in clinical studies with pasireotide (see section 4.8).
Slovenian: Pri preiskovancih v kliničnih študijah s pasireotidom so opažali hiperglikemijo in redkeje tudi hipoglikemijo (glejte poglavje 4.8).
English: It is also used to treat Cushing's disease in adult patients for whom surgery is not an option or for whom surgery has failed.
Slovenian: Uporabljamo ga tudi za zdravljenje tistih odraslih bolnikov s Cushingovo boleznijo, za katere kirurški poseg ni primeren oziroma pri katerih kirurški poseg ni bil uspešen.
English: PK exposures had a slight correlation with body weight in the study with medical treatment naïve patients, but not in the study with inadequately controlled patients.
Slovenian: V študiji z bolniki, ki predhodno še niso bili zdravljeni, je farmakokinetična izpostavljenost zdravilu nekoliko korelirala s telesno maso, kar pa ne velja za študijo z bolniki, pri katerih bolezen ni bila ustrezno urejena.
English: Signifor 0.3 mg solution for injection EU/1/12/753/001-004
Slovenian: Signifor 0,3 mg raztopina za injiciranje EU/1/12/753/001-004
English: Dose reductions or discontinuation of treatment with pasireotide due to hyperglycaemia were infrequent in clinical studies with pasireotide.
Slovenian: V kliničnih študijah s pasireotidom je redko prišlo do zniževanja odmerka ali prekinitve zdravljenja s pasireotidom zaradi hiperglikemije.
English: The thighs and the abdomen are good areas for subcutaneous injection.
Slovenian: Za subkutano injekcijo so primerna področja na stegnih in na trebuhu.
English: Signifor 60 mg powder and solvent for suspension for injection EU/1/12/753/016-017
Slovenian: Signifor 60 mg prašek in vehikel za suspenzijo za injiciranje EU/1/12/753/016-017
English: In acromegaly patients, gastrointestinal disorders were less frequent in inadequately controlled patients compared to medically naïve patients.
Slovenian: Pri bolnikih z akromegalijo, pri katerih bolezen ni bila ustrezno urejena, so bolezni prebavil opažali manj pogosto kot pri bolnikih, ki predhodno še niso bili zdravljeni.
English: Dose increase for efficacy was allowed at the discretion of the investigators after three and six months of treatment if biochemical parameters showed a mean GH ≥2.5 µg/l and/or IGF-1 >ULN (age and sex related).
Slovenian: Začetni odmerek intramuskularnega pasireotida je bil 40 mg, intramuskularnega oktreotida pa 20 mg. Za boljšo učinkovitost je bilo po presoji raziskovalca mogoče zvišati odmerke po treh in po šestih mesecih zdravljenja, če so bili biokemijski parametri ustrezni: povprečna vrednost rastnega hormona najmanj 2,5 µg/l in/ali povprečna vrednost faktorja IGF-1 >ZMN (glede na starost in spol).
English: Skin and subcutaneous tissue disorders
Slovenian: Bolezni kože in podkožja izpadanje las, pruritus
English: Active control N=68 n (%)
Slovenian: N=65 n (%), vrednost p primerjalno zdravilo N=68 n (%)
English: Included in the injection kit:
Slovenian: Komplet za injiciranje obsega:
English: The suppression of ACTH (adrenocorticotropic hormone) secretion can result in hypocortisolism in patients treated with Signifor.
Slovenian: Pri bolnikih, ki prejemajo zdravilo Signifor, lahko zaradi zaviranja sproščanja ACTH (adrenokortikotropnega hormona) pride do hipokortizolizma.
English: Signifor 20 mg powder and solvent for suspension for injection One vial contains 20 mg pasireotide (as pasireotide pamoate).
Slovenian: Signifor 20 mg prašek in vehikel za suspenzijo za injiciranje Ena viala vsebuje 20 mg pasireotida (v obliki pasireotidijevega pamoata).
English: 59.7% and 56% of patients in the pasireotide intramuscular use and octreotide intramuscular use treatment groups, respectively, were patients without previous pituitary surgery (de novo).
Slovenian: V skupini z intramuskularno uporabo pasireotida je bilo 59,7 % bolnikov brez predhodne operacije hipofize (novo odkritih bolnikov), medtem ko je bilo v skupini z intramuskularno uporabo oktreotida takih bolnikov 56 %.
English: Signifor 60 mg: each vial contains 60 mg pasireotide (as pasireotide pamoate).
Slovenian: Signifor 60 mg: ena viala vsebuje 60 mg pasireotida (v obliki pasireotidijevega pamoata).
English: Your doctor or nurse will have instructed you on how to use Signifor ampoules.
Slovenian: Zdravnik ali medicinska sestra vas bosta naučila, kako uporabljati ampule z zdravilom Signifor, kljub temu pa pred uporabo ampule natančno preberite tudi naslednje podatke.
English: Hepatic impairment Dose adjustment is not required in patients with mildly impaired hepatic function (Child Pugh A).
Slovenian: Pri bolnikih z blago okvarjenim delovanjem jeter (Child Pugh stopnje A) prilagajanje odmerkov ni potrebno.
English: More cases of discontinuation and a higher reporting rate of severe adverse events due to hyperglycaemia were reported in patients treated with the dose of 0.9 mg twice daily.
Slovenian: Pri bolnikih, ki so prejemali odmerek 0,9 mg dvakrat na dan, je v več primerih prišlo do prekinitve zdravljenja, z večjo pogostnostjo pa so poročali tudi o hudih neželenih dogodkih zaradi hiperglikemije.
English: Step 3
Slovenian: 3.korake
English: Pasireotide has been shown to prolong the QT interval on the ECG in two dedicated healthy volunteer studies.
Slovenian: V dveh študijah, namenjenih ugotavljanju vpliva na interval QT pri zdravih prostovoljcih, se je pri preiskavi EKG pokazalo, da pasireotid podaljšuje interval QT.
English: Studies in animals in which pasireotide was administered via the subcutaneous route have shown reproductive toxicity (see section 5.3).
Slovenian: Študije na živalih, v katerih so pasireotid odmerjali subkutano, so pokazale vpliv na sposobnost razmnoževanja (glejte poglavje 5.3).
English: Body weight has been found to be a covariate in the population pharmacokinetic analysis of Cushing's disease patients.
Slovenian: Pri analizi populacijske farmakokinetike pri bolnikih s Cushingovo boleznijo so ugotovili, da ima telesna masa vlogo sospremenljivke.
English: Signifor 20 mg is available in unit packs containing one vial of powder with 20 mg pasireotide and one pre-filled syringe with 2 ml solvent.
Slovenian: Zdravilo Signifor 20 mg je na voljo v posamičnih pakiranjih, ki vsebujejo po eno vialo s praškom z 20 mg pasireotida in eno napolnjeno injekcijsko brizgo z 2 ml vehikla.
English: Solution for injection
Slovenian: Priprava na injiciranje
English: Signifor 10 mg: each vial contains 10 mg pasireotide (as pasireotide pamoate).
Slovenian: Signifor 10 mg: ena viala vsebuje 10 mg pasireotida (v obliki pasireotidijevega pamoata).
English: If you have any questions, contact your doctor, nurse or pharmacist.
Slovenian: Če imate kakršnakoli vprašanja, se obrnite na zdravnika, medicinsko sestro ali farmacevta.
English: It is used to treat Cushing's disease in adult patients for whom surgery is not an option or for whom surgery has failed.
Slovenian: Uporabljamo ga za zdravljenje tistih odraslih bolnikov s Cushingovo boleznijo, za katere kirurški poseg ni primeren oziroma pri katerih kirurški poseg ni bil uspešen.
English: Signifor 40 mg: each vial contains 40 mg pasireotide (as pasireotide pamoate).
Slovenian: Signifor 40 mg: ena viala vsebuje 40 mg pasireotida (v obliki pasireotidijevega pamoata).
English: The injection site
Slovenian: raztopina za injiciranje
English: Signifor 30 mg: each vial contains 30 mg pasireotide (as pasireotide pamoate).
Slovenian: Signifor 30 mg: ena viala vsebuje 30 mg pasireotida (v obliki pasireotidijevega pamoata).
English: The study enrolled 162 patients with a baseline UFC >1.5 x ULN who were randomised in a 1:1 ratio to receive a subcutaneous dose of either 0.6 mg or 0.9 mg Signifor twice daily.
Slovenian: Bolnike so randomizirali v razmerju 1:1, in sicer tako, da so prejemali subkutane odmerke zdravila Signifor bodisi 0,6 mg ali 0,9 mg dvakrat na dan.
English: Signifor 40 mg powder and solvent for suspension for injection EU/1/12/753/014-015
Slovenian: Signifor 40 mg prašek in vehikel za suspenzijo za injiciranje EU/1/12/753/014-015
English: Signifor 60 mg powder and solvent for suspension for injection One vial contains 60 mg pasireotide (as pasireotide pamoate).
Slovenian: Signifor 60 mg prašek in vehikel za suspenzijo za injiciranje Ena viala vsebuje 60 mg pasireotida (v obliki pasireotidijevega pamoata).
English: Treatment should not be restarted if the liver function abnormalities are suspected to be related to pasireotide.
Slovenian: Če obstaja domneva, da je nepravilno delovanje jeter povezano s pasireotidom, se zdravljenja ne sme ponovno uvesti.
English: One vial contains 20 mg pasireotide (as pasireotide pamoate).
Slovenian: Ena viala vsebuje 20 mg pasireotida (v obliki pasireotidijevega pamoata).
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE (S) OF ADMINISTRATION
Slovenian: POSTOPEK IN POT(I) UPORABE ZDRAVILA
English: Signifor 10 mg is available in unit packs containing one vial of powder with 10 mg pasireotide and one pre filled syringe with 2 ml solvent.
Slovenian: Zdravilo Signifor 10 mg je na voljo v posamičnih pakiranjih, ki vsebujejo po eno vialo s praškom z 10 mg pasireotida in eno napolnjeno injekcijsko brizgo z 2 ml vehikla.
English: Signifor 30 mg is available in unit packs containing one vial of powder with 30 mg pasireotide and one pre filled syringe with 2 ml solvent.
Slovenian: Zdravilo Signifor 30 mg je na voljo v posamičnih pakiranjih, ki vsebujejo po eno vialo s praškom s 30 mg pasireotida in eno napolnjeno injekcijsko brizgo z 2 ml vehikla.
English: Signifor 0.9 mg injection pasireotide
Slovenian: Signifor 0,9 mg raztopina za injiciranje pasireotid