natgillin/translations-raw huggingface dataset:
Pregnancy, breast-feeding and fertility Ask your doctor or pharmacist for advice before using any medicine.
Nosečnost, dojenje in plodnost Posvetujte se z zdravnikom ali s farmacevtom, preden uporabite katerokoli zdravilo.
* Cholecystitis includes cholecystitis acute
* holecistitis vključuje akutni holecistitis
Take the sterile syringe and attach the needle to it.
Vzemite sterilno brizgo in nanjo namestite iglo.
If you have any questions about how Signifor works or why this medicine has been prescribed for you, ask your doctor.
Če vas zanima, kako zdravilo Signifor deluje ali zakaj so vam predpisali to zdravilo, se obrnite na svojega zdravnika.
The dose should not exceed 60 mg.
Odmerek ne sme presegati 60 mg.
The 60 mg strength is only to be used in the treatment of acromegaly.
Zdravilo v jakosti 60 mg je namenjeno samo za zdravljenje akromegalije.
During the pivotal study, HbA1c levels increased significantly and stabilised but did not return to baseline values (see section 4.8).
Med potekom ključne študije so se vrednosti HbA1c bistveno povečale in nato stabilizirale, niso pa se vrnile na izhodiščno vrednost (glejte poglavje 4.8).
These receptor subtypes are expressed in different tissues under normal physiological conditions.
V normalnih fizioloških pogojih se te podvrste receptorjev izražajo v različnih tkivih.
Table 2 Binding affinities of somatostatin (SRIF-14), pasireotide, octreotide and lanreotide to the five human somatostatin receptor subtypes (hsst1-5)
Preglednica 2 Vezavne afinitete somatostatina (SRIF-14), pasireotida, oktreotida in lanreotida za pet humanih podvrst receptorjev za somatostatin (hsst1-5)
Data on the use of Signifor in patients older than 65 years are limited, but there is no evidence to suggest that dose adjustment is required in these patients (see section 5.2).
O uporabi zdravila Signifor pri bolnikih, ki so stari več kot 65 let, je na voljo le malo podatkov, vendar ti ne kažejo, da bi bilo treba pri teh bolnikih prilagajati odmerjanje (glejte poglavje 5.2).
The apparent clearance (CL/F) of pasireotide intramuscular use in healthy volunteers is on average 4.5-8.5 litres/h.
Navidezni očistek (CL/F) pasireotida za intramuskularno uporabo je pri zdravih prostovoljcih v povprečju 4,5-8,5 l/h.
Cholecystitis includes cholecystitis acute and cholecystitis chronic.
Holecistitis vključuje akutni holecistitis in kronični holecistitis.
The dose should not exceed 40 mg.
Odmerek ne sme presegati 40 mg.
What Signifor is and what it is used for
Kaj je zdravilo Signifor in za kaj ga uporabljamo
Use of the same injection site for two consecutive injections is not recommended.
Za injiciranje ni priporočeno uporabiti istega injekcijskega mesta dvakrat zaporedoma.
A total of 181 patients completed the core phase (24 weeks) of the study.
Osnovno fazo v študiji (24 tednov) je zaključilo skupno 181 bolnikov.
For information on the instructions for use, please see the end of the package leaflet “How to inject Signifor”.
Za informacije glede napotkov za uporabo glejte zadnji del Navodila za uporabo “Kako injicirati zdravilo Signifor”.
Effect on female fertility
Vpliv na plodnost pri ženskah
If you stop using Signifor
Če ste prenehali uporabljati zdravilo Signifor
The frequency and severity of adverse reactions tended to be higher with the higher starting dose of 30 mg, but this was not consistent for all adverse reactions.
Pogostnost in izraženost neželenih učinkov sta bili pogosto večji pri uporabi višjega začetnega odmerka 30 mg, vendar to ne velja za vse neželene učinke.
During the extension phase, 74 patients continued receiving pasireotide intramuscular use and 46 patients continued with octreotide intramuscular use treatment.
V fazi podaljšanja je 74 bolnikov še naprej prejemalo pasireotid za intramuskularno uporabo, 46 bolnikov pa je nadaljevalo zdravljenje z oktreotidom za intramuskularno uporabo.
In the phase III studies, injection site related reactions (e.g. injection site pain, injection site discomfort) were mostly grade 1 or 2 in severity.
V študijah faze III so bile reakcije na mestu injiciranja (na primer bolečina na mestu injiciranja in neprijeten občutek na mestu injiciranja) večinoma stopnje 1 ali 2.
Pharmacotherapeutic group: Pituitary and hypothalamic hormones and analogues, somatostatin and analogues, ATC code: H01CB05
Farmakoterapevtska skupina: hipofizni in hipotalamični hormoni ter sorodne učinkovine, somatostatin in analogi, oznaka ATC: H01CB05
The injection can be prepared using either two different needles to draw up and inject the solution or one short fine injection needle for both steps.
Injekcija se lahko pripravi bodisi z uporabo dveh različnih igel za vnos raztopine v brizgo ter za injiciranje raztopine, bodisi z uporabo ene kratke tanke injekcijske igle za oba koraka.
No QTcF values >500 ms were observed in any of the pivotal studies.
Intervalov QTcF s trajanjem > 500 ms niso opažali v nobeni od ključnih študij.
For a range of 60-100 kg the reduction in AUCss with increasing weight is predicted to be approximately 27%, which is considered moderate and of minor clinical significance.
Pri razponu telesne mase od 60 do 100 kg je mogoče predvideti, da se bo AUCss z višanjem telesne mase zmanjšala za približno 27 %, kar velja za zmerno zmanjšanje in nima večjega kliničnega pomena.
How much Signifor to use
Koliko zdravila Signifor uporabljati
The median exposure to the treatment up to the cut-off date of the primary efficacy and safety analysis was 10.37 months (0.03-37.8), with 66.0% of patients having at least six months' exposure.
Povprečno trajanje izpostavljenosti zdravilu do vnaprej izbranega datuma za analizo primarnih ciljev učinkovitosti in varnosti je znašalo 10,37 meseca (od 0,03 do 37,8), pri čemer je bilo 66,0 % bolnikov izpostavljenih najmanj šest mesecev.
1 vial of powder
1 viala s praškom
If you forget to use Signifor
Če ste pozabili uporabiti zdravilo Signifor
If you have been told to use two needles, you should use the long thick blunt one for this step.
Če so vam naročili, da uporabljate dve igli, morate v tem koraku uporabiti dolgo, debelo in topo.
The mean age was 35.8 years, and the majority of patients were female (78.8%).
Povprečna starost bolnikov je bila 35,8 leta, večina jih je bila ženskega spola (78,8 %).
Insert the needle fully into the left or right gluteus at a 90° angle to the skin.
Iglo zabodite do konca v levi ali desni gluteus pod kotom 90°.
In the studied age range 18-73 years, the area under the curve at steady state for one dosing interval of 12 hours (AUCss) is predicted to range from 86% to 111% of that of the typical patient of 41 years.
V preučevanem starostnem okviru od 18 do 73 let je mogoče predvidevati, da bo površina pod krivuljo v stanju dinamičnega ravnovesja za en odmerni interval 12 ur (AUCss) v okviru od 86 % do 111 % vrednosti pri tipičnem bolniku v starosti 41 let.
To avoid sedimentation, you may gently shake the syringe to maintain a uniform suspension.
Da bi preprečili usedanje vsebine, lahko brizgo nežno stresate, tako da ostane suspenzija enotna.
This medicine comes in an ampoule, i.e. a small glass container.
To zdravilo je na voljo v ampuli, to je majhen steklen vsebnik.
If you are not sure about giving yourself the injection or if you have any questions, please ask your doctor or nurse for help.
Če niste prepričani, da si lahko sami injicirate zdravilo ali če imate kakršnakoli vprašanja, se za pomoč obrnite na svojega zdravnika ali medicinsko sestro.
The adenoma leads the body to over-produce hormones that control growth of tissues, organs and bones, resulting in an increase in the size of bones and tissues, especially in the hands and feet.
Adenom povzroči, da v telesu nastaja preveč hormonov, ki uravnavajo rast tkiv, organov in kosti, zato se kosti in tkiva povečajo, zlasti v dlaneh in stopalih.
Like the natural peptide hormones somatostatin-14 and somatostatin-28 (also known as somatotropin release inhibiting factor [SRIF]) and other somatostatin analogues, pasireotide exerts its pharmacological activity via binding to somatostatin receptors.
Podobno kot naravni peptidni hormoni somatostatin-14 in somatostatin-28 (ki ju imenujemo tudi sproščanje somatotropina zavirajoči hormon [angl. somatotropin release inhibiting factor, SRIF]) in drugi analogi somatostatina tudi pasireotid izraža svojo farmakološko aktivnost z vezavo na receptorje za somatostatin.
- If you are breast-feeding, ask your doctor for advice before taking this medicine, as it is not known whether Signifor passes into breast milk.
- Če dojite, se posvetujte z zdravnikom, preden začnete jemati to zdravilo, saj ni znano, ali zdravilo Signifor prehaja v materino mleko.
Follow the instructions below carefully to ensure proper reconstitution of Signifor powder and solvent for suspension for injection before deep intramuscular injection.
Natančno upoštevajte spodnja navodila, da boste zdravilo Signifor prašek in vehikel za suspenzijo za injiciranje pravilno rekonstituirali pred dajanjem z globoko intramuskularno injekcijo.
The next dose should then be planned for 4 weeks after the injection is administered in order to resume the normal schedule of one dose every 4 weeks.
Naslednji odmerek nato načrtujte 4 tedne po injiciranju odmerka, tako da boste spet vzpostavili normalni razpored jemanja enega odmerka na 4 tedne.
In healthy volunteers, pasireotide is rapidly absorbed and peak plasma concentration is reached within 0.25-0.5 h. Cmax and AUC are approximately dose-proportional following administration of single and multiple doses.
Pri zdravih prostovoljcih se pasireotid hitro absorbira in doseže najvišjo koncentracijo v plazmi v 0,25-0,5 h. Cmax in AUC sta približno sorazmerna višini odmerka, in sicer po aplikaciji enkratnega ali večkratnih odmerkov.
Population pharmacokinetic analyses of Signifor suggest that race and gender do not influence pharmacokinetic parameters.
Analiza populacijske farmakokinetike zdravila Signifor kaže, da rasa in spol ne vplivata na farmakokinetične parametre.
In subjects with moderate and severe hepatic impairment, AUCinf was increased 60% and 79%, Cmax was increased 67% and 69%, and CL/F was decreased 37% and 44%, respectively.
Pri osebah z zmerno oziroma s hudo okvaro jeter je bila AUCinf povečana za 60 % oziroma za 79 %, Cmax zvišana za 67 % oziroma za 69 %, očistek CL/F pa je bil znižan za 37 % oziroma za 44 %.
Pasireotide 0.9 mg twice daily % change (n)
pasireotid 0,9 mg dvakrat na dan odstotna sprememba (n)
Patients who have not responded to Signifor after two months of treatment should be considered for discontinuation.
Pri bolnikih, pri katerih po dveh mesecih ne pride do odziva na zdravilo Signifor, je treba razmisliti o prekinitvi zdravljenja.
• After adding the solvent, shake the vial moderately for a minimum of 30 seconds until a uniform suspension is formed.
• Po dodajanju vehikla vialo zmerno stresajte najmanj 30 sekund, dokler ne nastane enotna suspenzija.
Facial rubor improved in 43.5% (47/108) of patients, and more than a third of patients demonstrated improvement in supraclavicular fat pad (34.3%) and dorsal fat pad (34.6%).
Rdečica obraza se je izboljšala pri 43,5 % (47/108) bolnikov, pri več kot tretjini bolnikov je prišlo do izboljšanja glede supraklavikularnih maščobnih blazinic (34,3 %) in maščobnih blazinic na hrbtu (34,6 %).
The reconstituted Signifor is now ready for immediate administration.
Rekonstituirano zdravilo Signifor je zdaj pripravljeno za takojšnje injiciranje.
Improvements were observed in both dose groups for CushingQoL and the Mental Component Summary (MCS) of SF-12v2, but not for the Physical Component Summary (PCS) of SF-12v2.
Izboljšanja so opazili v obeh odmernih skupinah in sicer pri rezultatih vprašalnika CushingQoL in pri skupni oceni duševne komponente (angl. Mental Component Summary, MCS) vprašalnika SF-12v2, ne pa pri rezultatih skupne ocene fizične komponente (angl. Physical Component Summary, PCS) vprašalnika SF-12v2.
Slowly depress the plunger until the syringe is empty.
Počasi potiskajte bat navzdol, dokler brizga ni prazna.
Monitoring of liver function is recommended prior to treatment with pasireotide and after one, two, four, eight and twelve weeks during treatment.
Jetrno funkcijo je priporočeno spremljati pred začetkom zdravljenja s pasireotidom in en, dva, štiri, osem ter dvanajst tednov po začetku zdravljenja z njim.
If no clinical benefit is observed, the patient should be considered for discontinuation.
Če pri bolniku ni opaziti kliničnih koristi, je treba razmisliti o ukinitvi zdravljenja.
What Signifor is and what it is used for What you need to know before you use Signifor How to use Signifor
Kaj je zdravilo Signifor in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo Signifor Kako uporabljati zdravilo Signifor Možni neželeni učinki
OUTER CARTON OF MULTIPACK (INCLUDING BLUE BOX)
ŠKATLA ZA ZUNANJE PAKIRANJE V SKUPNEM PAKIRANJU (VKLJUČNO Z “BLUE BOX” PODATKI)
If such a switch should be required, it is recommended to maintain an interval of at least 28 days between the last intramuscular injection and the first subcutaneous injection, and to initiate the subcutaneous injections at a dose of 0.6 mg pasireotide twice a day.
Če je takšna zamenjava potrebna, se priporoča interval vsaj 28 dni med zadnjim injiciranjem intramuskularne oblike in prvim injiciranjem subkutane oblike ter začetno odmerjanje subkutane oblike zdravila v odmerku 0,6 mg pasireotida dvakrat dnevno.
ATTENTION: It is essential to start the reconstitution process only after the injection kit reaches room temperature.
OPOZORILO: Pomembno je, da s postopkom rekonstitucije začnete šele po tem, ko se komplet za injiciranje ogreje na sobno temperaturo.
Signifor 40 mg and Signifor 60 mg are also available in multipacks containing 3 intermediate packs.
Zdravili Signifor 40 mg in Signifor 60 mg sta na voljo tudi v skupnih pakiranjih, ki vsebujejo po 3 vmesna pakiranja.
Sites showing signs of inflammation or irritation should be avoided.
Pri tem se je treba izogibati mest, ki kažejo znake vnetja ali draženja.
Tap the syringe with your fingers to get rid of air bubbles.
S prsti rahlo krcnite brizgo, da se znebite zračnih mehurčkov.
After a single injection, the plasma pasireotide concentration shows an initial burst release on the injection day, followed by a dip from day 2 to day 7, then a slow increase to maximum concentration around day 21, and a slow declining phase over the next weeks, concomitant with the terminal degradation phase of the polymer matrix of the dosage form.
Po posamezni injekciji se koncentracija pasireotida v plazmi na dan injekcije sprva močno zviša, nato se od 2. do 7. dne znižuje, sledita pa počasno zviševanje do najvišje koncentracije, ki jo pasireotid doseže okrog 21. dne, in faza počasnega zniževanja koncentracije v nadaljnjih nekaj tednih, ki poteka sočasno s fazo dokončne razgradnje polimernega matriksa te odmerne oblike zdravila.
At the end of the core phase, patients achieving biochemical control or benefiting from the treatment as assessed by the investigator could continue to be treated in the extension phase with the study treatment to which they were initially randomised.
Po zaključku osnovne faze so bolnikom, ki so dosegli biokemijsko urejenost ali jim je zdravljenje po oceni raziskovalca koristilo na drug način, omogočili, da so zdravljenje nadaljevali še v fazi podaljšanja, in sicer z zdravilom, ki jim je bilo z randomizacijo dodeljeno na začetku.
• metformin, liraglutide, vildagliptin, nateglinide (antidiabetic medicines).
• metformin, liraglutid, vildagliptin, nateglinid (antidiabetiki).
Pasireotide for intramuscular use is formulated as microspheres for long-acting release.
Pasireotid za intramuskularno uporabo je izdelan v obliki mikrokroglic z dolgotrajnim sproščanjem.
The dose may be titrated every 2 to 4 months based on response and tolerability.
Odmerek se lahko titrira vsake 2 do 4 mesece na osnovi odziva na zdravljenje in prenašanje zdravila.
6 ampoules.
6 ampul.
Based on population pharmacokinetic (PK) analyses, the estimated CL/F was approximately 4.8 to 6.5 litres/h for typical Cushing's disease patients, and approximately 5.6 to 8.2 litres/h for typical acromegaly patients.
Po podatkih analize populacijske farmakokinetike je bil ocenjeni CL/F približno 4,8 do 6,5 litra/h pri tipičnih bolnikih s Cushingovo boleznijo in približno 5,6 do 8,2 litra/h pri tipičnih bolnikih z akromegalijo.
If you have liver disease before you start Signifor treatment for acromegaly, your doctor may want to start your treatment with a dose of 20 mg.
Če imate jetrno bolezen že pred začetkom zdravljenja akromegalije z zdravilom Signifor, vam bo zdravnik za začetek morda predpisal odmerek 20 mg.
It is not known whether Signifor passes into breast milk.
Ni znano, ali zdravilo Signifor prehaja v materino mleko.
Decreased total body clearance and increased pharmacokinetic exposures have been seen with increasing age.
Pri višji starosti so opažali zmanjšan celokupni telesni očistek in povečano farmakokinetično izpostavljenost zdravilu.
Severe hepatic impairment (Child Pugh C).
Huda okvara jeter (Child Pugh stopnje C).
• calcium channel blockers (bepridil, verapamil, diltiazem)
• zaviralci kalcijevih kanalčkov (bepridil, verapamil, diltiazem)
In Cushing's disease, the safety assessment of the intramuscular formulation was made based on 150 patients who received pasireotide in the phase III study G2304 (median duration of exposure: 57 weeks).
Pri Cushingovi bolezni ocena varnosti oblike za intramuskularno dajanje temelji na podatkih 150 bolnikov, ki so prejemali pasireotid v študiji faze III z oznako G2304 (mediano trajanje izpostavljenosti zdravilu: 57 tednov).
Signifor may have a minor influence on the ability to drive and use machines.
Zdravilo Signifor ima lahko blag vpliv na sposobnost vožnje in upravljanja strojev.
Thereafter liver function should be monitored as clinically indicated.
Kasneje je treba jetrno funkcijo določati le, če je to klinično indicirano.
In vitro studies have shown that corticotroph tumour cells from Cushing's disease patients display a high expression of hsst5, whereas the other receptor subtypes either are not expressed or are expressed at lower levels.
Rezultati študij in vitro so pokazali, da je na kortikotropnih tumorskih celicah bolnikov s Cushingovo boleznijo v velikem obsegu izražena podvrsta receptorja hsst5, medtem ko druge podvrste receptorja sploh niso izražene ali pa so izražene v manjši meri.
Most findings seen in repeated toxicity studies were reversible and attributable to the pharmacology of pasireotide.
Učinki, ki so jih opažali v študijah toksičnosti pri ponavljajočih se odmerkih, so bili večinoma reverzibilni in jih je bilo mogoče pripisati farmakološkemu delovanju pasireotida.
Paediatric population No studies have been performed in paediatric patients.
Pediatrična populacija Študij pri pediatričnih bolnikih niso izvajali.
Important safety information Caution: Keep the ampoules out of the reach of children.
Pomembna opozorila za varno uporabo Pozor: Ampule shranjujte nedosegljivo otrokom.
Effects in non-clinical studies were observed only at exposures considered sufficiently in excess of the maximum human exposure indicating little relevance to clinical use.
V predkliničnih študijah so učinke opažali samo pri izpostavljenostih, ki so dovolj presegale največjo izpostavljenost pri človeku, tako da pomen teh učinkov za klinično uporabo skorajda ni pomemben.
The presence of gallstones in Signifor-treated patients is largely asymptomatic; symptomatic stones should be managed according to clinical practice.
Pri bolnikih, ki prejemajo zdravilo Signifor, je prisotnost žolčnih kamnov večinoma asimptomatska, simptomatske žolčne kamne pa je treba zdraviti v skladu s klinično prakso.
The data described below reflect exposure of 162 Cushing's disease patients to Signifor in the phase III study.
Spodaj prikazani podatki odražajo izpostavljenost zdravilu Signifor pri 162 bolnikih s Cushingovo boleznijo v študiji faze III.
Based on the accumulation ratios of AUC, the calculated effective half-life (t1/2,eff) in healthy volunteers was approximately 12 hours.
Efektivni razpolovni čas (t1/2,eff), izračunan iz razmerja kopičenja na podlagi vrednosti AUC, je pri zdravih prostovoljcih znašal približno 12 ur.
Depending on the results and how you are feeling, the dose of Signifor given in each injection may need to be reduced or increased.
Glede na izvide in vaše počutje vam bo zdravnik morda moral zvišati ali znižati odmerek zdravila Signifor v vsaki injekciji.
To reduce local discomfort, it is recommended that the solution is at room temperature before administration.
Zaradi zmanjšanja lokalnega neugodja se priporoča, da je raztopina pred injiciranjem sobne temperature.
Injection site reactions were also reported in clinical studies in other populations.
O reakcijah na mestu injiciranja so poročali tudi v drugih kliničnih študijah z drugimi populacijami preiskovancev.
How long to use Signifor You should continue using Signifor for as long as your doctor tells you to.
Kako dolgo je treba uporabljati zdravilo Signifor Zdravilo Signifor uporabljajte tako dolgo, kot vam naroči zdravnik.
Overall reductions in these parameters tended to be greater in patients that were mUFC responders.
V celoti je bilo znižanje vrednosti navedenih parametrov večinoma večje pri bolnikih z odzivom vrednosti mUFC.
Ampoules should be opened just prior to administration, and any unused portion discarded.
Ampule je treba odpreti tik pred injiciranjem in neporabljen del zavreči.
An audible “click” confirms proper activation.
Ob uspešni aktivaciji lahko slišite "klik".
These reactions were usually of low grade, required no intervention and improved with continued treatment.
Ti učinki so bili običajno nizke stopnje, zdravstveni posegi pa zaradi njih niso bili potrebni in so se z nadaljevanjem zdravljenja izboljšali.
Within each system organ class, adverse reactions are ranked by frequency.
V posamezni skupini organskega sistema so neželeni učinki navedeni po pogostnosti.
FPG/HbA1c monitoring during treatment should follow established guidelines.
Razmerje FPG/HbA1c je treba v času zdravljenja spremljati v skladu z veljavnimi smernicami.
This variation is moderate and considered of minor significance considering the wide age range in which the effect was observed.
To odstopanje je zmerno in mu ne pripisujejo večjega pomena glede na to, da ga opažajo šele pri veliki starostni razliki.
Rapid, complete or near-complete suppression of ACTH may lead to a decrease in circulating levels of cortisol and potentially to transient hypocortisolism/hypoadrenalism.
Nenadno, popolno ali skoraj popolno zaviranje sproščanja ACTH zniža koncentracijo kortizola v krvnem obtoku in lahko povzroči prehoden hipokortizolizem/hipoadrenalizem.
In the pre- and postnatal study in rats, pasireotide had no effects on labour and delivery, but caused slight retardation in the development of pinna detachment and reduced body weight of the offspring.
V študiji pre- in postnatalnega obdobja pri podganah pasireotid ni vplival na popadke in porod, je pa povzročil manjši zaostanek v razvoju uhljev in zmanjšano telesno maso mladičev.
Slowly release the skin fold and gently pull the needle out.
Počasi spustite kožno gubo in nežno izvlecite iglo.
Due to the increase in unbound drug exposure, Signifor should be used with caution in patients with severe renal impairment or end stage renal disease (see section 5.2).
Zaradi povečane izpostavljenosti nevezanemu zdravilu je treba zdravilo Signifor uporabljati previdno pri bolnikih s hudo okvaro ledvic ali končno ledvično odpovedjo (glejte poglavje 5.2).
If you interrupt your treatment with Signifor your symptoms may come back.
Če prekinete zdravljenje z zdravilom Signifor, se lahko simptomi bolezni vrnejo.
Remove the injection kit from the fridge and let the kit stand at room temperature for a minimum of 30 minutes before reconstitution, but do not exceed 24 hours.
Komplet za injiciranje vzemite iz hladilnika in ga pred rekonstituiranjem pustite na sobni temperaturi najmanj 30 minut, vendar ne več kot 24 ur.