natgillin/translations-raw huggingface dataset:
Two cases of hyperglycaemia-related emergencies (diabetic ketoacidosis and diabetic hyperglycaemic coma) were reported following a dose increase of pasireotide to 60 mg in medical treatment naïve patients; one in a patient with untreated hyperglycaemia and HbA1c >8% prior to initiation of pasireotide and the other in a patient with untreated hyperglycaemia and a fasting plasma glucose of 359 mg/dl, respectively.
Pri dveh bolnikih, ki pred tem še nista bila zdravljena, so poročali o pojavu nujnih stanj zaradi hiperglikemije (diabetični ketoacidozi in diabetični hiperglikemični komi) po zvišanju odmerka pasireotida na 60 mg; v enem primeru je šlo za bolnika z nezdravljeno hiperglikemijo in HbA1c >8 % pred začetkom zdravljenja s pasireotidom in v drugem primeru za bolnika z nezdravljeno hiperglikemijo in s koncentracijo glukoze na tešče 359 mg/dl.
Month 12 * Includes one patient with significant outlying results who had a percent change from baseline of
12 mesecih * vključuje bolnika z izrazito izstopajočimi vrednostmi, pri katerem je bila odstotna sprememba od izhodišča +542,2 %
Dose adjustment of medicinal products such as beta blockers, calcium channel blockers, or medicinal products to control electrolyte balance, may be necessary (see also section 4.5).
V nekaterih primerih je treba prilagoditi tudi odmerjanje zdravil, kot so antagonisti adrenergičnih receptorjev beta, zaviralci kalcijevih kanalčkov ali zdravil za uravnavanje elektrolitskega ravnovesja (glejte tudi poglavje 4.5).
Population PK analyses of pasireotide intramuscular use suggest that race does not influence PK parameters.
Analiza populacijske farmakokinetike pasireotida za intramuskularno uporabo kaže, da rasa ne vpliva na farmakokinetične parametre.
For further details on handling, see section 6.6.
Za podrobnejša navodila za rokovanje z zdravilom glejte poglavje 6.6.
Signifor is to be administered by deep intramuscular injection by a trained healthcare professional.
Zdravilo Signifor mora z globoko intramuskularno injekcijo dati usposobljen zdravstveni delavec.
Patients who develop increased transaminase levels should be monitored with a second liver function evaluation to confirm the finding.
Pri bolnikih, pri katerih je prišlo do zvišanja vrednosti aminotransferaz, je treba za potrditev izvida opraviti še eno oceno jetrne funkcije.
Table 1 Adverse reactions in the phase III study in Cushing's disease patients
Preglednica 1 Neželeni učinki v študiji faze III pri bolnikih s Cushingovo boleznijo
In study C2402, grade 3 elevated fasting glucose levels were reported in 14.3% and 17.7% of acromegaly patients treated with pasireotide intramuscular use 40 mg and 60 mg respectively, and in no patients in the active control group.
V študiji C2402 so o stopnji 3 zvišanja vrednosti glukoze v krvi na tešče poročali pri 14,3 % oziroma 17,7 % bolnikov z akromegalijo, ki so prejemali pasireotid za intramuskularno uporabo v odmerku 40 mg oziroma v odmerku 60 mg, in pri nobenem od bolnikov iz aktivne kontrolne skupine.
Pasireotide demonstrates low clearance (CL/F ~7.6 litres/h for healthy volunteers and ~3.8 litres/h for Cushing's disease patients).
Pasireotid ima majhen očistek (CL/F je pri zdravih prostovoljcih ~7,6 l/h, pri bolnikih s Cushingovo boleznijo pa ~3,8 l/h).
The safety profile of pasireotide intramuscular use is consistent with the somatostatin analogue class, except for the higher degree and frequency of hyperglycaemia seen with pasireotide intramuscular use.
Varnostni profil pasireotida za intramuskularno uporabo je bil podoben kot pri drugih zdravilih iz skupine analogov somatostatina, z izjemo povečane stopnje in pogostnosti hiperglikemije, ki so jo opažali pri intramuskularni uporabi pasireotida.
Remove the packaging from the vial adapter by lifting it straight up as shown.
Odstranite ovojnino z adapterja za vialo s potegom naravnost navzgor, kot je prikazano na sliki.
Injection site reaction includes injection site pain, injection site nodule, injection site discomfort, injection site bruising, injection site pruritus, injection site reaction, injection site hypersensitivity and injection site swelling.
Reakcija na mestu injiciranja vključuje bolečino na mestu injiciranja, vozliček na mestu injiciranja, neprijeten občutek na mestu injiciranja, podplutbo na mestu injiciranja, srbenje na mestu injiciranja, reakcijo na mestu injiciranja, preobčutljivost na mestu injiciranja in oteklino na mestu injiciranja.
Rare cases of concurrent elevations in ALT (alanine aminotransferase) greater than 3 x ULN and bilirubin greater than 2 x ULN have also been observed (see section 4.8).
Redko so opažali tudi primere sočasno zvišanih vrednosti ALT (alaninaminotransferaze) nad 3-kratnik zgornje meje normalnih vrednosti (ZMN) in bilirubina nad 2-kratnik ZMN (glejte poglavje 4.8).
Signifor is available in packs containing 6 ampoules or in multipacks containing 18 (3 packs of 6), 30 (5 packs of 6) or 60 (10 packs of 6) ampoules.
Zdravilo Signifor je na voljo v pakiranju, ki vsebuje 6 ampul, ali v skupnem pakiranju, ki vsebuje 18 (3 pakiranja po 6), 30 (5 pakiranj po 6) ali 60 (10 pakiranj po 6) ampul.
Packs containing 6 ampoules or multipacks containing 18 (3 x 6), 30 (5 x 6) or 60 (10 x 6) ampoules.
Pakiranje vsebuje 6 ampul, skupno pakiranje pa vsebuje 18 (3 x 6), 30 (5 x 6) ali 60 (10 x 6) ampul.
In both studies, mean FPG and HbA1c levels peaked within the first three months of treatment with pasireotide intramuscular use.
V obeh študijah sta povprečna vrednost glukoze v krvi na tešče in povprečna vrednost HbA1c dosegli najvišje vrednosti v prvih treh mesecih zdravljenja s pasireotidom za intramuskularno uporabo.
Somatostatin receptors are expressed in many tissues, especially in neuroendocrine tumours in which hormones are excessively secreted, including GH in acromegaly and 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 rastnim hormonom pri akromegaliji in ACTH pri Cushingovi bolezni.
A baseline ECG is recommended prior to initiating therapy with Signifor.
Izhodiščno EKG preiskavo je priporočeno izvesti pred začetkom zdravljenja z zdravilom Signifor.
Pharmacokinetic steady state for pasireotide intramuscular use is achieved after three months.
Pasireotid za intramuskularno uporabo doseže stanje farmakokinetičnega dinamičnega ravnovesja po treh mesecih.
In the Cushing's disease study G2304, a QTcF value >480 ms was reported for 2 patients.
V študiji Cushingove bolezni z oznako G2304 so o intervalu QTcF, daljšem od 480 ms, poročali pri 2 bolnikih.
If you have liver disease before you start Signifor treatment, your doctor may want to start your treatment with a dose of one ampoule of Signifor 0.3 mg twice a day.
Če imate pred začetkom zdravljenja z zdravilom Signifor jetrno bolezen, vam bo zdravnik za začetek morda predpisal odmerek ene ampule zdravila Signifor 0,3 mg dvakrat na dan.
Solvent: clear, colourless to slightly yellow or slightly brown solution.
Vehikel: bistra, brezbarvna do nekoliko rumena ali nekoliko rjava raztopina.
Pasireotide is not recommended for use during pregnancy and in women of childbearing potential who are not using contraception (see section 4.4).
Pasireotida ne uporabljajte pri nosečnicah in pri ženskah v rodni dobi, ki ne uporabljajo učinkovite kontracepcije (glejte poglavje 4.4).
Monitoring of liver enzymes is recommended before and during treatment with Signifor (see section 4.4), as clinically appropriate.
Pred in med zdravljenjem z zdravilom Signifor je priporočeno spremljanje vrednosti jetrnih encimov (glejte poglavje 4.4), in sicer v skladu s kliničnimi potrebami.
The primary efficacy end-point was the proportion of patients in each arm who achieved normalisation of mean 24-hour UFC levels (UFC ≤ULN) after 6 months of treatment and who did not have a dose increase (relative to randomised dose) during this period.
Primarni cilj opazovanja za oceno učinkovitosti je bil v vsaki skupini delež bolnikov, ki so po 6 mesecih zdravljenja dosegli normalizacijo 24-urne vrednosti UFC (UFC ≤ZMN) in jim v tem obdobju niso zvišali odmerka (v primerjavi z odmerkom, določenim pri randomizaciji).
The most common adverse reactions (incidence ≥10%) were diarrhoea, nausea, abdominal pain, cholelithiasis, injection site reactions, hyperglycaemia, diabetes mellitus, fatigue and glycosylated haemoglobin increased.
Najbolj pogosti neželeni učinki (s pogostnostjo ≥10 %) so bili diareja, navzea, bolečine v trebuhu, holelitiaza, reakcije na mestu injiciranja, hiperglikemija, sladkorna bolezen, utrujenost in zvišana vrednost glikiranega hemoglobina.
The influence of the P-gp inhibitor verapamil on the pharmacokinetics of subcutaneous pasireotide was tested in a drug-drug interaction study in healthy volunteers.
Predvidene farmakokinetične interakcije, ki bi lahko vplivale na pasireotid Učinek verapamila, ki je zaviralec P-gp (P-glikoproteina), na farmakokinetiko subkutano apliciranega pasireotida so preverjali v študiji medsebojnega delovanja zdravil na zdravih prostovoljcih.
Reductions in serum cortisol and plasma ACTH levels were also observed at month 7 and 12 for each dose group.
Po 7 in 12 mesecih so pri obeh odmernih skupinah opažali tudi znižanje vrednosti kortizola v serumu in ACTH v plazmi.
No studies have been conducted to evaluate the bioavailability of pasireotide in humans.
Študij za vrednotenje biološke uporabnosti pasireotida pri ljudeh niso izvajali.
Two-thirds of all patients had undergone prior surgery.
Dve tretjini bolnikov sta predhodno že prestali kirurški poseg.
The reactions were most frequently reported as local pain, erythema, haematoma, haemorrhage and pruritus.
Reakcije so najbolj pogosto opisovali kot lokalno bolečino, rdečino, hematom, krvavitev ali srbenje.
The primary efficacy end point was the proportion of patients in each arm who achieved mean 24-hour UFC levels ≤ULN after 7 months of treatment, regardless of prior dose increase.
Primarni cilj opazovanja učinkovitosti je bil v vsaki skupini delež bolnikov, ki so po 7 mesecih zdravljenja dosegli povprečno 24-urno vrednost UFC v višini največ ZMN ne glede na predhodno zviševanje odmerka.
Pasireotide should be used with caution in patients who are concomitantly receiving medicinal products that prolong the QT interval, such as class Ia antiarrhythmics (e.g. quinidine, procainamide, disopyramide), class III antiarrhythmics (e.g. amiodarone, dronedarone, sotalol, dofetilide, ibutilide), certain antibacterials (intravenous erythromycin, pentamidine injection, clarithromycin, moxifloxacin), certain antipsychotics (e.g. chlorpromazine, thioridazine, fluphenazine, pimozide, haloperidol, tiapride, amisulpride, sertindole, methadone), certain antihistamines (e.g. terfenadine, astemizole, mizolastine), antimalarials (e.g. chloroquine, halofantrine, lumefantrine), certain antifungals (ketoconazole, except in shampoo) (see also section 4.4).
Pasireotid je treba uporabljati previdno pri bolnikih, ki sočasno prejemajo zdravila, ki podaljšujejo interval QT, kot so antiaritmiki razreda Ia (na primer kinidin, prokainamid, dizopiramid), antiaritmiki razreda III (na primer amiodaron, dronedaron, sotalol, dofetilid, ibutilid), določeni antibiotiki (intravenski eritromicin, injekcija pentamidina, klaritromicin, moksifloksacin), določeni antipsihotiki (na primer klorpromazin, tioridazin, flufenazin, pimozid, haloperidol, tiaprid, amisulprid, sertindol, metadon), določeni antihistaminiki (na primer terfenadin, astemizol, mizolastin), antimalariki (na primer klorokin, halofantrin, lumefantrin), določeni antimikotiki (ketokonazol, z izjemo ketokonazola v šamponu) (glejte tudi poglavje 4.4).
Patients should receive instructions from the physician or a healthcare professional on how to inject Signifor subcutaneously.
Zdravnik ali drug zdravstveni strokovnjak mora bolnika poučiti, kako naj si subkutano injicira zdravilo Signifor.
Patients were randomised in a 1:1 ratio to a starting dose of either 10 mg or 30 mg pasireotide intramuscular use every 4 weeks.
Bolnike so randomizirali v razmerju 1:1 na prejemanje začetnega odmerka bodisi 10 mg ali 30 mg pasireotida za intramuskularno uporabo vsake 4 tedne.
Cushing's disease is caused by an enlargement in the pituitary gland (a gland at the base of the brain) called a pituitary adenoma.
Cushingovo bolezen povzroča povečanje hipofize (žleze na spodnji strani možganov), kar imenujemo adenom hipofize.
Baseline characteristics were balanced between the two randomised dose groups, except for marked differences in the mean value of baseline 24-hour UFC (1156 nmol/24 h for the 0.6 mg twice daily group and 782 nmol/24 h for the 0.9 mg twice daily group; normal range 30-145 nmol/24 h).
Izhodiščne značilnosti bolnikov so bile v obeh randomiziranih skupinah enakomerno razporejene, z izjemo bistvene razlike pri povprečju izhodiščne 24-urne vrednosti UFC (1156 nmol/24 h v skupini z odmerkom 0,6 mg dvakrat na dan in 782 nmol/24 h v skupini z odmerkom 0,9 mg dvakrat na dan; pri čemer so normalne vrednosti 30-145 nmol/24 h).
It is unknown whether pasireotide is excreted in human milk.
Ni znano, ali se pasireotid izloča v materino mleko.
Hypocortisolism
Hipokortizolizem
The recommended dose is one ampoule of Signifor 0.6 mg twice a day.
Priporočeni odmerek je ena ampula zdravila Signifor 0,6 mg dvakrat na dan.
A dose increase to 0.9 mg may be considered based on the response to the treatment, as long as the 0.6 mg dose is well tolerated by the patient.
Glede na odziv na zdravljenje je mogoče odmerek zvišati na 0,9 mg, če bolnik dobro prenaša odmerek 0,6 mg.
Signifor should only be administered by a trained healthcare professional.
Zdravilo Signifor sme aplicirati samo usposobljen zdravstveni delavec.
Therapy with pasireotide should be discontinued if the patient develops jaundice or other signs suggestive of clinically significant liver dysfunction, in the event of a sustained increase in AST (aspartate aminotransferase) or ALT of 5 x ULN or greater, or if ALT or AST elevations greater than 3 x ULN occur concurrently with bilirubin elevations greater than 2 x ULN.
Zdravljenje s pasireotidom je treba prekiniti, če pride do ikterusa ali drugih znakov, ki nakazujejo klinično pomembno motnjo delovanja jeter, v primeru vztrajno zvišanih vrednosti AST (aspartat-aminotransferaze) ali ALT do 5kratnika ZMN ali več ali v primeru, da so sočasno zvišane vrednosti ALT ali AST nad 3-kratnik ZMN in vrednosti bilirubina nad 2-kratnik ZMN.
ATTENTION:
OPOZORILO:
Always keeping your skin pinched, slowly press the plunger down as far as it will go until all the solution is injected.
Medtem ko stiskate kožno gubo, počasi potiskajte bat navzdol, dokler gre in dokler niste injicirali raztopine v celoti.
Renal clearance has a minor contribution to the elimination of pasireotide in humans.
Izločanje preko ledvic pri človeku le malo prispeva k izločanju pasireotida.
Twelve months after crossover, the percentage of patients achieving biochemical control was 17.3% (14/81) for pasireotide intramuscular use and 0% (0/38) for octreotide intramuscular use.
Dvanajst mesecev po navzkrižni zamenjavi zdravila je biokemijsko urejenost bolezni doseglo 17,3 % bolnikov (14/81) v skupini z intramuskularno uporabo pasireotida in 0 % bolnikov (0/38) v skupini z intramuskularno uporabo oktreotida.
Each unit pack contains the vial and pre-filled syringe in a sealed blister tray with one vial adapter and one safety-engineered needle for injection.
Eno posamično pakiranje vsebuje vialo in napolnjeno injekcijsko brizgo v neprodušno zaprtem pretisnem omotu skupaj z enim adapterjem za vialo in eno varno oblikovano iglo za injiciranje.
At month 25, 48.6% of patients (36/74) in the pasireotide intramuscular use group and 45.7% (21/46) in the octreotide intramuscular use group achieved biochemical control.
Po 25 mesecih je biokemijsko urejenost bolezni doseglo 48,6 % bolnikov (36/74) v skupini z intramuskularno uporabo pasireotida in 45,7 % bolnikov (21/46) v skupini z intramuskularno uporabo oktreotida.
Additionally, tolerability and repeated dose toxicity studies were conducted with pasireotide via the intramuscular route.
Poleg tega so izvedli še študije prenosljivosti in toksičnosti pri ponavljajočih se odmerkih s pasireotidom za intramuskularno uporabo.
Multipacks (40 mg and 60 mg strengths only): each multipack contains 3 intermediate cartons, each containing a blister tray with one injection kit (one vial and, in a separate sealed section, one pre-filled syringe, one vial adapter and one safety engineered needle for injection).
Skupna pakiranja (samo jakosti 40 mg in 60 mg): eno skupno pakiranje vsebuje 3 vmesne škatle, od katerih vsaka vsebuje pretisni omot z enim kompletom za injiciranje (z eno vialo in eno napolnjeno injekcijsko brizgo v ločenem neprodušno zaprtem predelku, enim adapterjem za vialo in eno varno oblikovano iglo za injiciranje).
Prepare the injection site with an alcohol wipe.
Mesto injiciranja obrišite z alkoholno blazinico.
Female patients of childbearing potential should be advised to use adequate contraception if necessary during treatment with Signifor (see section 4.6).
Bolnicam v rodni dobi je treba svetovati, naj v času zdravljenja z zdravilom Signifor uporabljajo primerno kontracepcijo, če je to potrebno (glejte poglavje 4.6).
In a pooled analysis of the two pivotal studies, the overall incidence of hyperglycaemia-related adverse reactions was 58.6% (all grades) and 9.9% (CTC Grade 3 and 4) for Signifor intramuscular use versus 18.0% (all grades) and 1.1% (CTC Grade 3 and 4) for the active control.
V analizi združenih podatkov dveh ključnih študij je skupna pogostnost vseh s hiperglikemijo povezanih neželenih učinkov znašala 58,6 % (za vse stopnje) oziroma 9,9 % (za stopnji 3 in 4 po kriterijih CTC) pri uporabi zdravila Signifor za intramuskularno uporabo v primerjavi z 18,0 % (za vse stopnje) oziroma 1,1 % (za stopnji 3 in 4 po kriterijih CTC) pri uporabi primerjalnega zdravila.
Single use.
za enkratno uporabo
Pasireotide should be used with caution and the benefit risk carefully weighed in patients who are at significant risk of developing prolongation of QT, such as those: - with congenital long QT syndrome.
Pasireotid je treba uporabljati previdno in skrbno pretehtati razmerje med koristmi in tveganji pri bolnikih, pri katerih obstaja pomembno tveganje za podaljšanje intervala QT, kot so bolniki: - s prirojenim sindromom dolgega intervala QT; - z neurejeno ali s pomembno boleznijo srca, kar vključuje nedavni miokardni infarkt,
Powder: brownish vial (glass) with rubber stopper (chlorobutyl rubber), containing the active substance (pasireotide).
Prašek: viala rjavkaste barve (steklena) z gumijasto zaporko (iz klorobutilne gume), ki vsebuje učinkovino (pasireotid).
Treatment of adult patients with acromegaly for whom surgery is not an option or has not been curative and who are inadequately controlled on treatment with another somatostatin analogue.
Zdravljenje odraslih bolnikov z akromegalijo, za katere kirurški poseg ni primeren oziroma pri katerih kirurški poseg ni odpravil bolezni, pri tem pa bolezen ni ustrezno urejena z zdravljenjem z drugim analogom somatostatina.
If such a switch should be required, the recommended initial dose for the treatment of Cushing's disease is 10 mg of pasireotide by deep intramuscular injection every 4 weeks.
Če je takšna zamenjava potrebna, je priporočeni začetni odmerek za zdravljenje Cushingove bolezni 10 mg pasireotida z globoko intramuskularno injekcijo vsake 4 tedne.
In Cushing's disease patients, pasireotide demonstrates linear and time-independent pharmacokinetics in the dose range of 0.3 mg to 1.2 mg twice a day.
Farmakokinetika pasireotida je pri bolnikih s Cushingovo boleznijo v obsegu odmerkov od 0,3 mg do 1,2 mg dvakrat na dan linearna in neodvisna od časa.
One-point-cut colourless, type I glass ampoule containing 1 ml of solution.
Ampula z eno točko za prelom iz brezbarvnega stekla tipa I, ki vsebuje 1 ml raztopine.
The relative bioavailability of pasireotide intramuscular use over pasireotide subcutaneous use is complete.
Relativna biološka uporabnost pasireotida za intramuskularno uporabo v celoti dosega biološko uporabnost pasireotida pri subkutani uporabi.
Pancreatitis is a potential adverse reaction associated with the use of somatostatin analogues due to the association between cholelithiasis and acute pancreatitis.
Vnetje trebušne slinavke je možen neželeni učinek pri uporabi analogov somatostatina, in sicer zaradi povezave med holelitiazo in akutnim vnetjem trebušne slinavke.
Solvent: colourless pre-filled syringe (glass) with front and plunger stopper (chlorobutyl rubber), containing 2 ml solvent.
Vehikel: brezbarvna napolnjena injekcijska brizga (steklena) z batnim tesnilom in zaviralom (iz klorobutilne gume), ki vsebuje 2 ml vehikla.
Patients were randomised in a 1:1 ratio to one of two treatment groups in each of the following two strata: 1) patients who had undergone one or more pituitary surgeries but had not been treated medically or 2) de novo patients presenting a visible pituitary adenoma on MRI who had refused pituitary surgery or for whom pituitary surgery was contraindicated.
Bolnike so randomizirali v razmerju 1:1 v eno od dveh študijskih skupin, obe sta bili stratificirani na naslednji dve kategoriji: 1. bolniki, ki so prestali eno ali več operacij hipofize, niso pa prejemali zdravil, in 2. novo odkriti bolniki, ki imajo na magnetnoresonančnem (MR) posnetku viden adenom hipofize in so odklonili operacijo hipofize ali je taka operacija za njih kontraindicirana.
The European Medicines Agency has waived the obligation to submit the results of studies with Signifor in all subsets of the paediatric population in pituitary-dependant Cushing's disease, overproduction of pituitary ACTH and pituitary dependant hyperadrenocorticism (see section 4.2 for information on paediatric use).
Evropska agencija za zdravila je odstopila od zahteve za predložitev rezultatov študij z zdravilom Signifor za vse podskupine pediatrične populacije pri od hipofize odvisni Cushingovi bolezni, pri prekomerni tvorbi ACTH v hipofizi in pri od hipofize odvisnem hiperadrenokorticizmu (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
Pasireotide binds with high affinity to four of the five hssts.
Pasireotid se z veliko afiniteto veže na štiri od petih receptorjev hsst.
Your treatment with Signifor should continue for as long as your doctor tells you that it is necessary.
Z zdravljenjem z zdravilom Signifor boste nadaljevali tako dolgo, kot bo po zdravnikovi presoji potrebno.
The elevations of fasting plasma glucose and HbA1c observed with pasireotide intramuscular use treatment are reversible after discontinuation.
Zvišanje vrednosti glukoze v krvi na tešče in vrednosti HbA1c, ki so ga opažali pri zdravljenju s pasireotidom za intramuskularno uporabo, je po prekinitvi zdravljenja izzvenelo.
Pasireotide is a cyclohexapeptide, injectable somatostatin analogue.
Pasireotid je cikloheksapeptid, analog somatostatina v obliki za injiciranje.
In Cushing's disease patients, elevated FPG levels was the most frequently reported CTC Grade 3 laboratory abnormality (14.7% of patients) in the phase III study G2304; with no cases of Grade 4 reported.
Pri bolnikih s Cushingovo boleznijo je bila zvišana vrednost glukoze v plazmi na tešče (fasting plasma glucose, FPG) najpogosteje prijavljeni patološki laboratorijski izvid stopnje 3 po kriterijih CTC (pri 14,7 % bolnikov) v študiji faze III z oznako G2304, pri čemer niso poročali o nobenem primeru patološkega izvida stopnje 4.
INSTRUCTIONS FOR USE OF SIGNIFOR SOLUTION FOR INJECTION
NAVODILA ZA UPORABO SIGNIFOR RAZTOPINE ZA INJICIRANJE
- Signifor may cause your blood sugar to increase.
- Zdravilo Signifor vam lahko zviša koncentracijo sladkorja v krvi.
30 ampoules (5x6)
30 ampul (5x6)
The degree of hyperglycaemia appeared to be higher in patients with pre-diabetic conditions or established diabetes mellitus.
Kaže, da je stopnja hiperglikemije višja pri bolnikih s predstopnjo sladkorne bolezni in pri tistih z že ugotovljeno sladkorno boleznijo.