natgillin/translations-raw huggingface dataset:
Use syringes and needles only once. 
Vsako brizgo ali iglo lahko uporabite samo enkrat.
The recommended initial dose is 0.6 mg pasireotide by subcutaneous injection twice a day. 
Priporočeni začetni odmerek je 0,6 mg pasireotida s subkutano injekcijo dvakrat na dan.
The study met its primary efficacy endpoint for both pasireotide intramuscular use doses. 
Primarni cilj opazovanja glede učinkovitosti je bil dosežen pri obeh odmerkih pasireotida za intramuskularno uporabo.
Decreases were also demonstrated by the overall percentage change from baseline in mean and median mUFC levels at month 7 and 12. 
Znižanja so se pokazala tudi pri skupni odstotni spremembi glede na izhodišče v povprečnih in medianih vrednostih mUFC po 7 in 12 mesecih.
The coloured dot on the top part marks the position of the breaking point on the neck of the ampoule. 
Obarvana pika na vrhnjem delu označuje mesto lomilne zareze na vratu ampule.
Most patients (82.0%) had undergone prior pituitary surgery, and the mean baseline mUFC was 470 nmol/24h (ULN: 166.5 nmol/24h). 
Večina bolnikov (82,0 %) je že prestala operacijo hipofize, njihova povprečna izhodiščna vrednost mUFC pa je bila 470 nmol/24 h (ZMN: 166,5 nmol/24 h).
Dispose of the used syringe and needle immediately in a sharps container or other rigid closed disposal container. 
Uporabljeno brizgo in iglo takoj zavrzite v vsebnik za ostre predmete ali drug trden zabojnik za odpadke z dobrim zapiranjem.
After four months of treatment, patients with mUFC ≤1.5xULN continued on the blinded dose to which they were randomised, and patients with mUFC >1.5xULN had their doses increased in a blinded manner from 10 mg to 30 mg, or from 30 mg to 40 mg, provided there were no tolerability concerns. 
Po štirih mesecih zdravljenja so bolniki z vrednostjo mUFC ≤ 1,5 x ZMN nadaljevali slepo zdravljenje z odmerkom, ki so jim ga določili pri randomizaciji, bolnikom z vrednostjo mUFC > 1,5 x ZMN pa so odmerke zvišali na slep način z 10 mg na 30 mg oziroma s 30 mg na 40 mg, če niso imeli težav s prenašanjem odmerka.
Mean fasting plasma glucose levels commonly increased within the first month of treatment, with decreases and stabilisation observed in subsequent months. 
Povprečne vrednosti glukoze v plazmi na tešče so se v prvem mesecu zdravljenja pogosto zvišale, v naslednjih mesecih pa so opažali njihovo znižanje in stabilizacijo.
During the extension phase, tumour volume continued to decrease. 
V fazi podaljšanja se je pri bolnikih tumorska masa še naprej zmanjševala.
Signifor is thus able to block the production of ACTH, helping to control the over-production of cortisol and improve the symptoms of Cushing's disease. 
Zdravilo Signifor tako lahko zavre tvorbo hormona ACTH, kar pomaga uravnavati prekomerno nastajanje kortizola in izboljša simptome Cushingove bolezni.
Signifor is a medicine that contains the active substance pasireotide. 
Signifor je zdravilo, ki vsebuje zdravilno učinkovino pasireotid.
Make sure there is no air bubble in the syringe by pressing the plunger until the first drop appears on the tip of the needle. 
Poskrbite, da v brizgi ne bo zračnih mehurčkov: na bat pritisnite samo toliko, da se na vrhu igle pojavi kapljica.
Not following them could result in failure to deliver the injection appropriately. 
Če ju ne izvedete pravilno, se lahko zgodi, da zdravila z injiciranjem ne boste odmerili pravilno.
A supportive efficacy analysis was conducted in which patients were further classified into 3 response categories regardless of up-titration at month 3: Fully controlled (UFC ≤1.0 x ULN), partially controlled (UFC >1.0 x ULN but with a reduction in UFC ≥50% compared to baseline) or uncontrolled (reduction in UFC <50%). 
V podporo tej analizi so izvedli dodatno analizo učinkovitosti, za katero so bolnike nadalje razdelili v 3 kategorije odziva ne glede na zviševanje odmerka po 3 mesecih: povsem urejeni bolniki (z vrednostjo UFC ≤1,0 x ZMN), deloma urejeni bolniki (z vrednostjo UFC >1,0 x ZMN, a z znižanjem vrednosti UFC za ≥50 % v primerjavi z izhodiščno vrednostjo) in neurejeni bolniki (z znižanjem vrednosti UFC za <50 %).
Non-clinical safety data from studies performed with pasireotide administered via the subcutaneous route reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity and carcinogenic potential. 
Predklinični podatki o varnosti iz študij s pasireotidom za subkutano uporabo ne kažejo posebnega tveganja za človeka na osnovi običajnih študij farmakološke varnosti, toksičnosti pri ponavljajočih odmerkih, genotoksičnosti in kancerogenega potenciala.
Signifor must be given only by deep intramuscular injection. 
Zdravilo Signifor se sme dati samo z globokim intramuskularnim injiciranjem.
Switch from intramuscular to subcutaneous formulation 
Prehod z intramuskularne na subkutano obliko zdravila
The percentage of patients achieving biochemical control, including those patients with IGF-1 <LLN was 25.9% in the pasireotide intramuscular use group and 0% in the octreotide intramuscular use group. 
Odstotek bolnikov, ki so dosegli biokemijsko urejenost, je vključno z bolniki, pri katerih je bila vrednost faktorja IGF-1 pod spodnjo mejo normalnih vrednosti, znašal 25,9 % v skupini z intramuskularno uporabo pasireotida in 0 % v skupini z intramuskularno uporabo oktreotida.
Pasireotide is metabolically highly stable and in vitro data show that pasireotide is not a substrate, inhibitor or inducer of CYP450. 
Pasireotid je metabolično zelo stabilen in podatki raziskav in vitro kažejo, da ni substrat, zaviralec ali induktor CYP450.
After three months of treatment, patients with a mean 24-hour UFC ≤2 x ULN and below or equal to their baseline value continued blinded treatment at the randomised dose until month 6. 
Po treh mesecih zdravljenja so bolniki s povprečno 24-urno vrednostjo UFC ≤2 x ZMN, ki je bila hkrati nižja ali enaka njihovi izhodiščni vrednosti, do konca 6. meseca nadaljevali slepo zdravljenje z odmerkom, ki so jim ga določili pri randomizaciji.
51.6% p=0.536 * Primary endpoint (patients with IGF-1 <lower limit of normal (LLN) were not considered “responders”). 
51,6 % p=0,536 * primarni cilj opazovanja (bolniki z vrednostjo faktorja IGF-1 pod spodnjo mejo normalnih vrednosti (SMN) niso veljali za "bolnike z odzivom")
Doses up to 2.1 mg twice a day have been used in healthy volunteers, with the adverse reaction diarrhoea being observed at a high frequency. 
Pri zdravih prostovoljcih so uporabljali odmerke do 2,1 mg dvakrat na dan, pri čemer so kot neželeni učinek zelo pogosto opažali diarejo.
If hyperglycaemia develops in a patient being treated with Signifor, the initiation or adjustment of antidiabetic treatment is recommended, following the established treatment guidelines for the management of hyperglycaemia. 
Če pri bolniku, ki prejema zdravilo Signifor, pride do hiperglikemije, je priporočeno začeti z antidiabetičnim zdravljenjem oziroma prilagoditi odmerjanje antidiabetikov v skladu z veljavnimi smernicami za ukrepanje v primeru hiperglikemije.
• beta blockers (metoprolol, carteolol, propranolol, sotalol) 
• antagonisti adrenergičnih receptorjev beta (metoprolol, karteolol, propranolol, sotalol)
Secondary end-points included, among others, changes from baseline in: 24-hour UFC, plasma ACTH, serum cortisol levels, and clinical signs and symptoms of Cushing's disease. 
Sekundarni cilji opazovanja so bile med drugim spremembe od izhodiščnih vrednosti pri: 24-urni vrednosti UFC, vrednosti ACTH v plazmi in vrednosti kortizola v serumu ter pri kliničnih znakih in simptomih Cushingove bolezni.
In healthy volunteers, pasireotide is widely distributed with large apparent volume of distribution (Vz/F >100 litres). 
Pri zdravih prostovoljcih se pasireotid obsežno porazdeli z velikim navideznim volumnom porazdelitve (Vz/F >100 litrov).
During your treatment with Signifor - Signifor controls over-production of cortisol. 
V času zdravljenja z zdravilom Signifor - Zdravilo Signifor uravnava prekomerno nastajanje kortizola.
This leads the body to over-produce a hormone called adrenocorticotropic hormone (ACTH), which in turn results in over-production of another hormone called cortisol. 
Povečanje te žleze povzroči, da v telesu nastaja preveč hormona, ki ga imenujemo adrenokortikotropni hormon (ACTH), zaradi tega pa nastaja preveč drugega hormona, ki ga imenujemo kortizol.
At therapeutic dose levels pasireotide is also not an inhibitor of UGT1A1, OATP1B1 or 1B3, OAT1 or OAT3, OCT1 or OCT2, P-gp, BCRP, MRP2 and BSEP. 
Pasireotid na ravni terapevtskih odmerkov prav tako ni zaviralec UGT1A1, OATP1B1 ali 1B3, OAT1 ali OAT3, OCT1 ali OCT2, P-gp, BCRP, MRP2 in BSEP.
No studies have been conducted to evaluate the absolute bioavailability of pasireotide in humans. 
Študij za vrednotenje absolutne biološke uporabnosti pasireotida pri ljudeh niso izvajali.
In acromegaly, the safety assessment was made based on 491 patients who received pasireotide (419 patients received pasireotide intramuscular use and 72 received pasireotide subcutaneous use) in phase I, II and III studies. 
Pri akromegaliji ocena varnosti temelji na študijah faze I, II in III pri 491 bolnikih, ki so prejemali pasireotid (419 bolnikov je prejemalo pasireotid za intramuskularno uporabo in 72 pasireotid za subkutano uporabo).
Sinus bradycardia includes bradycardia and sinus bradycardia. 
Sinusna bradikardija vključuje bradikardijo in sinusno bradikardijo.
What Signifor contains - The active substance is pasireotide. 
Kaj vsebuje zdravilo Signifor - Učinkovina je pasireotid.
All analyses were conducted based on the randomised dose groups. 
Vse analize so opravili po odmernih skupinah, kot so jih določili pri randomizaciji.
As a result, it reduces the symptoms of acromegaly, which include headache, increased sweating, numbness of the hands and feet, tiredness and joint pain. 
To omogoča zmanjšanje simptomov akromegalije, ki vključujejo glavobol, prekomerno znojenje, odrevenelost dlani in stopal, utrujenost in bolečine v sklepih.
Somatostatin analogues bind to hsst receptors with different potencies (see Table 2). 
Analogi somatostatina se različno močno vežejo na receptorje hsst (glejte preglednico 2).
If uncontrolled hyperglycaemia persists despite appropriate medical management, the dose of Signifor should be reduced or Signifor treatment discontinued (see also section 4.5). 
Če hiperglikemije ni mogoče odpraviti z ustreznimi zdravili, je treba odmerek zdravila Signifor znižati ali prekiniti zdravljenje z njim (glejte tudi poglavje 4.5).
The study met the primary efficacy objective for both dose groups (lower bound of the 95% CI for the response rate of each treatment arm >15%). 
V študiji so dosegli primarni cilj učinkovitosti v obeh odmernih skupinah (spodnja meja 95-odstotnega intervala zaupanja za stopnjo odziva pri vsaki od odmernih skupin višja od 15 %).
At therapeutic dose levels pasireotide is also not an inhibitor of UGT1A1, OATP, 1B1 or 1B3, P-gp, BCRP, MRP2 and BSEP. 
Pasireotid na ravni terapevtskih odmerkov prav tako ni zaviralec UGT1A1, OATP, 1B1 ali 1B3, P-gp, BCRP, MRP2 in BSEP.
Patients with baseline HbA1c ≥7% or who were taking antidiabetic medicinal products prior to randomisation tended to have higher mean changes in fasting plasma glucose and HbA1c relative to other patients. 
Pri bolnikih, ki so imeli izhodiščno vrednost HbA1c ≥7 % ali so pred randomizacijo že jemali antidiabetična zdravila, je prišlo do nekoliko večje povprečne spremembe vrednosti glukoze v plazmi na tešče in HbA1c v primerjavi z drugimi bolniki.
Patients were randomised in a 1:1 ratio to receive starting doses of either 10 mg or 30 mg pasireotide, with a possibility to up-titrate to a maximum dose of 40 mg every 28 days. 
Bolniki so bili randomizirani v razmerju 1:1 na prejemanje začetnih odmerkov bodisi 10 mg ali 30 mg pasireotida z možnostjo zviševanja do najvišjega odmerka 40 mg vsakih 28 dni.
• metformin, liraglutide, vildagliptin, nateglinide (antidiabetic medicines); - medicines to treat irregular heartbeat, such as medicines containing disopyramide, 
• metformin, liraglutid, vildagliptin, nateglinid (antidiabetiki); - zdravila za zdravljenje nepravilnega srčnega ritma, kot so zdravila, ki vsebujejo dizopiramid,
If the finding is confirmed, the patient should be followed with frequent liver function monitoring until values return to pre-treatment levels. 
V primeru potrjenega izvida je treba pri bolniku pogosto določati jetrno funkcijo, dokler se vrednosti ne vrnejo na raven pred zdravljenjem.
In patients with poor glycaemic control, diabetes management and monitoring should be intensified prior to initiation and during pasireotide therapy. 
Pri bolnikih s slabo urejeno glikemijo je treba pred začetkom zdravljenja s pasireotidom in med samim zdravljenjem z njim intenzivirati zdravljenje in nadzor sladkorne bolezni.
In healthy volunteers, pasireotide intramuscular use is widely distributed with large apparent volume of distribution (Vz/F >100 litres). 
Pri zdravih prostovoljcih se pasireotid za intramuskularno uporabo obsežno porazdeli z velikim navideznim volumnom porazdelitve (Vz/F >100 litrov).
At month 12, reduction in tumour volume was comparable between the treatment groups and in patients with and without previous pituitary surgery. 
Po 12 mesecih je bilo zmanjšanje tumorja primerljivo v obeh študijskih skupinah ter med bolniki s predhodno operacijo hipofize oziroma brez nje.
If not used within 24 hours, the injection kit can be returned to the fridge. 
Če kompleta niste uporabili v roku 24 ur, ga lahko ponovno shranite v hladilnik.
What Signifor looks like and contents of the pack Signifor powder is a slightly yellowish to yellowish powder in a vial. 
Izgled zdravila Signifor in vsebina pakiranja Prašek zdravila Signifor je nekoliko rumenkast do rumenkast prašek v viali.
6 ampoules 
6 ampul
Monitoring of blood glucose levels in patients treated with Signifor is recommended (see section 4.4). 
Pri bolnikih, ki prejemajo zdravilo Signifor, je priporočeno spremljanje vrednosti glukoze v krvi (glejte poglavje 4.4).
Your doctor or nurse will instruct you on how to inject yourself with Signifor. 
Zdravnik ali medicinska sestra vas bosta naučila, kako si lahko sami injicirate zdravilo Signifor.
The primary efficacy endpoint was met; the percentage of patients achieving biochemical control was 31.3% and 19.2% for pasireotide intramuscular use and octreotide intramuscular use, respectively, demonstrating a statistically significant superior result favouring pasireotide intramuscular use (p-value = 0.007) (Table 4). 
Primarni cilj opazovanja je bil dosežen; delež bolnikov, ki so dosegli biokemijsko urejenost, je bil 31,3 % pri intramuskularni uporabi pasireotida in 19,2 % pri intramuskularni uporabi oktreotida, in sicer s statistično značilno boljšim rezultatom pri intramuskularni uporabi pasireotida (vrednost p = 0,007) (preglednica 4).
The proportion of patients who either attained mUFC ≤ULN or a mUFC reduction from baseline of at least 50% was 50.0% in the 10 mg dose group and 56.6% in the 30 mg dose groups (Table 5). 
Delež bolnikov, pri katerih je prišlo bodisi do znižanja vrednosti mUFC ≤ ZMN ali do znižanja vrednosti mUFC za najmanj 50 % od izhodiščne vrednosti, je bil v odmerni skupini z odmerkom 10 mg 50,0 %, v odmerni skupini z odmerkom 30 mg pa 56,6 % (preglednica 5).
Biochemical control was achieved early in the study (i.e. month 3) by a higher proportion of patients in the pasireotide intramuscular use arm than in the octreotide intramuscular use arm (30.1% and 21.4%) and was maintained in all subsequent evaluations during the core phase. 
Biokemijsko urejenost v zgodnjem poteku študije (po 3 mesecih) so bolniki v večjem deležu dosegli v skupini z intramuskularno uporabo pasireotida kot v skupini z intramuskularno uporabo oktreotida (30,1 % v primerjavi z 21,4 %), ohranili pa so jo pri vseh nadaljnjih meritvah v osnovni fazi študije.
The efficacy and safety of pasireotide intramuscular use was evaluated in a phase III, multicentre study over a 12-month treatment period in Cushing's disease patients with persistent or recurrent disease or de novo patients for whom surgery was not indicated or who refused surgery. 
Učinkovitost in varnost pasireotida za intramuskularno uporabo so ocenjevali v multicentrični študiji faze III v 12-mesečnem obdobju zdravljenja pri bolnikih s Cushingovo boleznijo, ki so imeli persistentno ali ponavljajočo bolezen oziroma so jim bolezen šele odkrili in niso bili primerni za kirurški poseg ali pa so ga odklonili.
The most common adverse reactions (incidence ≥1/10) in the phase III study G2304 were hyperglycaemia, diarrhoea, cholelithiasis and diabetes mellitus. 
Najpogostejši neželeni učinki (s pogostnostjo ≥ 1/10) v študiji faze III z oznako G2304 so bili hiperglikemija, diareja, holelitiaza in sladkorna bolezen.
Patients who develop increased transaminase levels should be monitored frequently until values return to pre-treatment levels. 
Pri bolnikih, pri katerih je prišlo do zvišanja vrednosti aminotransferaz, je treba te pogosto določati, dokler se vrednosti ne vrnejo na raven pred zdravljenjem.
Management of suspected adverse reactions at any time during the treatment may require temporary dose reduction of Signifor. 
Pri sumu na neželen učinek kadarkoli v času zdravljenja je v nekaterih primerih treba začasno znižati odmerek zdravila Signifor.
The response in the 0.9 mg dose arm seemed to be higher for patients with lower mean UFC at baseline. 
Kaže, da je bil v skupini z odmerkom 0,9 mg odziv večji pri bolnikih, ki so imeli nižjo povprečno vrednost UFC ob izhodišču.
The proportion of patients with a reduction of tumour volume greater than 20% at month 12 was 80.8% for pasireotide intramuscular use and 77.4% for octreotide intramuscular use. 
Delež bolnikov z zmanjšanjem tumorske mase za več kot 20 % je bil po 12 mesecih 80,8 % v skupini z intramuskularno uporabo pasireotida in 77,4 % v skupini z intramuskularno uporabo oktreotida.
Pull slightly on the plunger to check that a blood vessel has not been punctured. 
Bat potegnite nekoliko nazaj, da se prepričate, da niste nabodli krvne žile.
Reductions in plasma ACTH levels were also observed at each time point for each dose group. 
Ob vsakem času opazovanja so pri obeh skupinah z različnima odmerkoma opažali tudi znižanje vrednosti ACTH v plazmi.
The phase III clinical studies in acromegaly patients did not identify any clinically meaningful differences in the QT prolongation events between pasireotide intramuscular use and the somatostatin analogues which were tested as active comparator. 
V kliničnih študijah faze III pri bolnikih z akromegalijo niso ugotovili nobenih klinično pomembnih razlik v s podaljševanjem intervala QT povezanih dogodkih, med intramuskularno uporabo pasireotida in uporabo analogov somatostatina, ki so bili uporabljeni kot primerjalno zdravilo.
Patients had to be treated with maximum indicated doses of octreotide intramuscular use (30 mg) or lanreotide deep subcutaneous injection (120 mg) for at least 6 months prior to randomisation. 
Bolniki so morali biti pred randomizacijo najmanj 6 mesecev zdravljeni z najvišjimi indiciranimi odmerki oktreotida za intramuskularno uporabo (30 mg) ali lanreotida za globoko subkutano injiciranje (120 mg).
Following discontinuation of treatment with pasireotide, patients should be monitored until resolution. 
Po prekinitvi zdravljenja s pasireotidom je treba bolnike spremljati do normalizacije izvidov.
At study entry patients were randomised to receive twice-daily doses of either 0.6 mg or 0.9 mg Signifor. 
Pri vstopu v študijo so bolnike randomizirali tako, da so dvakrat na dan prejemali bodisi 0,6 mg ali 0,9 mg zdravila Signifor.
In study C2402, the only notable outlier was a QTcF value >480 ms in 1 patient in the pasireotide intramuscular use 40 mg group. 
V študiji C2402 je bila edina opazna izredna vrednost trajanje intervala QTcF več kot 480 ms pri enem bolniku iz skupine s pasireotidom za intramuskularno uporabo v odmerku 40 mg.
The unbound plasma pasireotide exposure (AUCinf,u) was increased in subjects with renal impairment (mild: 33%; moderate: 25%, severe: 99%, ESRD: 143%) compared to control subjects. 
Povečana pa je bila izpostavljenost nevezanemu pasireotidu pri osebah z okvaro ledvic (blaga okvara: 33 %, zmerna okvara: 25 %, huda okvara: 99 %, končna odpoved ledvic: 143 %) glede na kontrolo.
Somatostatin receptors are expressed in many tissues, especially in neuroendocrine tumours in which hormones are excessively secreted, including ACTH in Cushing's disease. 
Receptorji za somatostatin se izražajo v mnogih tkivih, zlasti v nevroendokrinih tumorjih, v katerih se prekomerno sproščajo hormoni, vključno z ACTH pri Cushingovi bolezni.
Management of suspected adverse reactions or over-response to treatment (IGF-1 < lower limit of normal) may require temporary dose reduction of Signifor. 
Pri sumu na neželen učinek ali premočnem odzivu na zdravljenje (IGF-1 < spodnje meje normalne vrednosti) je v nekaterih primerih treba začasno znižati odmerek zdravila Signifor.
After you have started treatment, your doctor may reassess your dose. 
Po začetku zdravljenja lahko zdravnik ponovno oceni, kolikšen odmerek potrebujete.
Remove the plastic cap from the vial and clean the rubber stopper of the vial with an alcohol wipe. 
Z viale snemite plastični pokrovček in očistite gumijasto zaporko na viali z alkoholnim zložencem.
In a clinical study in subjects with impaired hepatic function (Child-Pugh A, B and C), statistically significant differences were found in subjects with moderate and severe hepatic impairment (Child-Pugh B and C). 
V kliničnih študijah pri osebah z okvaro jetrne funkcije (Child-Pugh razredov A, B in C) so ugotovili statistično značilne razlike pri osebah z zmerno oziroma s hudo okvaro jeter (Child-Pugh razredov B in C).
Acromegaly is caused by a type of tumour called a pituitary adenoma which develops in the pituitary gland at the base of the brain. 
Akromegalijo povzroča vrsta tumorja z imenom adenom hipofize, ki nastane v hipofizi na spodnji strani možganov.
Glucose metabolism 
Metabolizem glukoze
Switch from subcutaneous to intramuscular formulation in Cushing's disease There are no clinical data available on switching from the subcutaneous to the intramuscular pasireotide formulation. 
Prehod s subkutane na intramuskularno obliko zdravila pri Cushingovi bolezni Kliničnih podatkov glede prehoda s subkutane na intramuskularno obliko pasireotida ni na voljo.
After you have started treatment, your doctor may also decide to increase your dose to one ampoule of Signifor 0.9 mg twice a day. 
Po začetku zdravljenja se lahko zdravnik odloči, da vam zviša odmerek na eno ampulo zdravila Signifor 0,9 mg dvakrat na dan.
Most patients (83.3%) had persistent or recurrent Cushing's disease and few (≤5%) in either treatment group had received previous pituitary irradiation. 
Večina bolnikov (83,3 %) je imela persistentno ali rekurentno obliko Cushingove bolezni in nekaj bolnikov (≤5 %) iz vsake od zdravljenih skupin je bilo predhodno zdravljenih z obsevanjem hipofize.
Put the needle into the ampoule and pull the plunger to draw up the entire contents of the ampoule into the syringe. 
Iglo vstavite v ampulo in potegnite bat, tako da povlečete vso vsebino iz ampule v brizgo.
Injection site reaction* 
reakcija na mestu injiciranja*
Avoid soreness and skin irritation by choosing a different site from the previous one for each injection. 
Bolečini in vnetju kože se poskušajte izogniti tako, da si vsakokrat izberete drugo mesto injiciranja.
Signifor solution for injection should be free of visible particles, clear and colourless. 
Raztopina za injiciranje Signifor ne sme vsebovati vidnih delcev in mora biti bistra in brezbarvna.
In addition, monitoring of FPG 4 weeks and HbA1c 3 months after the end of the treatment should be performed. 
Poleg tega je treba vrednosti glukoze na tešče spremljati še 4 tedne po zaključku zdravljenja, vrednosti HbA1c pa 3 mesece po zaključku zdravljenja.
Rapid decreases in cortisol levels may be associated with decreases in white blood cell count. 
Hitro znižanje ravni kortizola je lahko povezano z znižanjem števila levkocitov.
Signifor is intended for intramuscular use. 
Zdravilo Signifor je namenjeno za intramuskularno uporabo.
60 ampoules (10x6) 
60 ampul (10x6)