natgillin/translations-raw huggingface dataset:
Available toxicological data in animals have shown excretion of pasireotide in milk.
Dostupni toksikološki podaci u životinja pokazali su izlučivanje pasireotida u mlijeku.
What Signifor contains - The active substance is pasireotide.
Što Signifor sadrži - Djelatna tvar je pasireotid.
- Signifor may cause your blood sugar to increase.
- Signifor bi mogao uzrokovati povećanje šećera u krvi.
Pasireotide 30 mg N=76
Pasireotid 30 mg N=76
The mean age of patients was approximately 40 years and the majority of patients (77.8%) were female.
Srednja dob bolesnika bila je otprilike 40 godina, a većina bolesnika (77,8%) bile su žene.
You should also avoid injections at sites that are sore or where the skin is irritated.
Također trebate izbjegavati injekcije na mjestima koja su bolna ili na kojima je koža nadražena.
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.
Provjerite da nema mjehurića zraka u štrcaljki tako što ćete pritisnuti klip dok se na vrhu igle ne pojavi prva kapljica.
Sinus bradycardia includes bradycardia and sinus bradycardia.
Sinusna bradikardija uključuje bradikardiju i sinusnu bradikardiju.
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.
Nakon jednokratne injekcije, koncentracija pasireotida u plazmi pokazuje početno naglo oslobađanje na dan injekcije, nakon čega slijedi pad od 2. do 7. dana, a zatim sporo povećanje do maksimalne koncentracije oko 21. dana te spora faza opadanja tijekom narednih tjedana, istodobno s fazom terminalne degradacije polimernog matriksa farmaceutskog oblika.
Adrenal insufficiency*
Adrenalna insuficijencija*
Treatment should not be restarted if the liver function abnormalities are suspected to be related to pasireotide.
Ne smije se ponovno započinjati liječenje ako se sumnja da su abnormalnosti u funkciji jetre povezane s pasireotidom.
The dose could be reduced by decrements of 0.3 mg twice daily at any time during the study for reasons of intolerability.
Doza se mogla smanjiti za po 0,3 mg dvaput na dan u bilo kojem trenutku tijekom ispitivanja zbog nepodnošljivosti.
After you have started treatment, your doctor may reassess your dose.
Nakon što ste započeli liječenje, liječnik bi mogao ponovno procijeniti Vašu dozu.
To avoid sedimentation, you may gently shake the syringe to maintain a uniform suspension.
Da biste izbjegli sedimentaciju možete lagano protresti štrcaljku kako bi suspenzija ostala jednolična.
Somatostatin analogues bind to hsst receptors with different potencies (see Table 2).
Analozi somatostatina vežu se za hsst receptore različitim snagama (vidjeti Tablicu 2).
Before you proceed to step 4, clean the injection site with an alcohol wipe.
Prije nego što prijeđete na korak 4, očistite mjesto primjene injekcije tupferom natopljenim alkoholom.
Overall reductions in these parameters were observed in patients with full and partial mean UFC control but tended to be greater in patients with normalised UFC.
Ukupna smanjenja u tim parametrima bila su uočena u bolesnika s potpunom i djelomičnom kontrolom srednjeg UFC-a, ali obično su bila veća u bolesnika s normaliziranim UFC-om.
Signifor suspension must only be prepared immediately before administration.
Suspenzija Signifora mora se pripremiti tek neposredno prije primjene.
Tap the ampoule with your finger in order to make sure there is no liquid in the top part when you open the ampoule.
Lagano kucnite ampulu prstom kako biste osigurali da nema tekućine u gornjem dijelu ampule kada ju otvarate.
Not following them could result in failure to deliver the injection appropriately.
Ako ih se ne pridržavate, moguće je da nećete moći pravilno primijeniti injekciju.
If uncontrolled hyperglycaemia persists despite appropriate medical management, the dose of Signifor should be reduced or Signifor treatment discontinued (see also section 4.5).
Ako nekontrolirana hiperglikemija ustraje usprkos odgovarajućem medicinskom zbrinjavanju, treba smanjiti dozu Signifora ili prekinuti liječenje Signiforom (vidjeti također dio 4.5).
Breast-feeding should be discontinued during treatment with Signifor.
Dojenje treba prekinuti za vrijeme liječenja Signiforom.
Two months after the start of Signifor therapy, patients should be evaluated for clinical benefit.
Dva mjeseca nakon početka terapije Signiforom kod bolesnika treba procijeniti kliničku korist.
The thighs and the abdomen are good areas for subcutaneous injection.
Bedra i trbuh su dobra područja za potkožnu injekciju.
In the event of overdose, it is recommended that appropriate supportive treatment be initiated, as dictated by the patient's clinical status, until resolution of the symptoms.
U slučaju predoziranja, preporučuje se započinjanje odgovarajućeg potpornog liječenja, u skladu s bolesnikovim kliničkim statusom, do povlačenja simptoma.
Pregnancy, breast-feeding and fertility Ask your doctor or pharmacist for advice before using any medicine.
Trudnoća, dojenje i plodnost Obratite se svom liječniku ili ljekarniku za savjet prije nego uzmete bilo koji lijek.
The presence of gallstones in Signifor-treated patients is largely asymptomatic; symptomatic stones should be managed according to clinical practice.
Prisutnost žučnih kamenaca u bolesnika liječenih Signiforom uglavnom je asimptomatska; simptomatske kamence treba zbrinjavati u skladu s kliničkom praksom.
If you forgot to inject a dose of Signifor, simply inject the next dose at the scheduled time.
Ako ste zaboravili ubrizgati dozu Signifora, jednostavno ubrizgajte sljedeću dozu u predviđeno vrijeme.
You may experience sudden back pain or pain in the right side of your abdomen.
Možete osjetiti iznenadnu bol u leđima ili bol na desnoj strani trbuha.
* Cholecystitis includes cholecystitis acute
*Kolecistitis uključuje akutni kolecistitis
The mean age was 35.8 years, and the majority of patients were female (78.8%).
Srednja dob bila je 35,8 godina, a većina bolesnika bila je ženskog spola (78,8%).
Check the expiry date and the dose
Provjerite rok valjanosti i dozu
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.
Zbog adenoma tijelo proizvodi previše hormona koji kontroliraju rast tkiva, organa i kostiju, što rezultira povećanjem veličine kostiju i tkiva, osobito u šakama i stopalima.
To prepare Signifor for deep intramuscular injection, please adhere to the following instructions:
Da biste pripremili Signifor za duboku intramuskularnu injekciju slijedite upute u nastavku:
• insulin;
• inzulin;
Medicinal products that prolong the QT interval
Lijekovi koji produžuju QT interval
The two treatment groups were well balanced in terms of baseline demographics and disease characteristics.
Dvije terapijske skupine bile su dobro uravnotežene u smislu početnih demografskih podataka i karakteristika bolesti.
Severe hepatic impairment (Child Pugh C).
Teško oštećenje jetre (Child Pugh C).
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.
In vitro ispitivanja pokazala su da kortikotropne tumorske stanice bolesnika s Cushingovom bolešću imaju visoku ekspresiju hsst5, dok druge podvrste receptora ili nisu izražene ili su izražene u manjoj mjeri.
Follow the instructions below carefully to ensure proper reconstitution of Signifor powder and solvent for suspension for injection before deep intramuscular injection.
Pažljivo slijedite upute u nastavku kako biste osigurali pravilnu rekonstituciju Signifor praška i otapala za suspenziju za injekciju prije duboke intramuskularne injekcije.
Pharmacotherapeutic group: Pituitary and hypothalamic hormones and analogues, somatostatin and analogues, ATC code: H01CB05
Farmakoterapijska skupina: hipofizni i hipotalamički hormoni i analozi, somatostatin i analozi, ATK oznaka: H01CB05
Pasireotide for intramuscular use is formulated as microspheres for long-acting release.
Pasireotid za intramuskularnu primjenu formuliran je u obliku mikrosfera za dugotrajno oslobađanje.
If you have been told to use two needles, you should use the long thick blunt one for this step.
Ako Vam je rečeno da koristite dvije igle, za ovaj korak koristite dugačku debelu tupu iglu.
It is particularly important that you mention any of the following medicines: - ciclosporin (used in organ transplantation to reduce the activity of the immune system); - medicines to treat blood sugar levels that are too high (as in diabetes) or too low (hypoglycaemia), such as:
Osobito je važno da spomenete ako uzimate bilo koji od sljedećih lijekova: - ciklosporin (koristi se kod presađivanja organa da bi se smanjila aktivnost imunološkog sustava); - lijekove za liječenje razina šećera u krvi koje su previsoke (kao kod šećerne bolesti) ili preniske (hipoglikemija), kao što su:
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.
U ispitanika s umjerenim i teškim oštećenjem jetre, AUCinf se povećao 60% odnosno 79%, Cmax se povećao 67% odnosno 69%, a CL/F se smanjio 37% odnosno 44%.
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.
Medijan izloženosti liječenju do isključnog datuma za primarnu analizu djelotvornosti i sigurnosti bio je 10,37 mjeseci (0,03-37,8), pri čemu je 66,0% bolesnika bilo izloženo terapiji najmanje šest mjeseci.
• cholinesterase inhibitors (rivastigmine, physostigmine); - medicines to control the balance of electrolytes (potassium, magnesium) in your body.
• inhibitori kolinesteraze (rivastigmin, fizostigmin), - lijekove za kontroliranje ravnoteže elektrolita (kalija, magnezija) u Vašem tijelu.
During your treatment with Signifor: - Signifor may cause your blood sugar to increase.
Tijekom liječenja Signiforom - Signifor bi mogao uzrokovati povećanje šećera u krvi.
No change in the pharmacokinetics (rate or extent of exposure) of pasireotide was observed.
Nije uočena promjena u farmakokinetici (brzini ili opsegu izloženosti) pasireotida.
In patients treated with pasireotide intramuscular use in whom reductions in GH and IGF-1 levels were observed, these changes occurred during the first 3 months of treatment and were maintained up to week 24.
U bolesnika liječenih pasireotidom primijenjenim intramuskularno u kojih su uočena smanjenja razina GH-a i IGF-1, te su se promjene javile tijekom prva 3 mjeseca liječenja i održale su se do 24. tjedna.
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.
Ako imate bolest jetre prije nego što započnete liječenje Signiforom za akromegaliju, liječnik će možda htjeti da započnete liječenje dozom od 20 mg.
The eligibility criteria included a mean urinary free cortisol (mUFC) value of between 1.5 and 5 times upper limit of normal (ULN) at screening.
Kriteriji podobnosti uključivali su srednju vrijednost slobodnog kortizola u urinu (mUFC) između 1,5 i 5 puta gornje granice normale (GGN) na probiru.
Myalgia, arthralgia
Mijalgija, artralgija
If you stop using Signifor
Ako prestanete primjenjivati Signifor
Frequencies were defined as follows: Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100).
Učestalost je definirana na sljedeći način: vrlo često (≥1/10); često (≥1/100 i <1/10); manje često (≥1/1000 i <1/100).
If no clinical benefit is observed, the patient should be considered for discontinuation.
Ukoliko nije opažena klinička korist u bolesnika, potrebno je razmotriti obustavu primjene.
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.
Na kraju osnovne faze, bolesnici koji su postigli biokemijsku kontrolu ili imali koristi od liječenja prema procjeni ispitivača mogli su se nastaviti liječiti u fazi produžetka ispitivanom terapijom na koju su inicijalno bili randomizirani.
Your doctor will regularly monitor your condition to check that the treatment is having the desired effect.
Vaše stanje da bi provjerio ima li terapija željeni učinak.
Patients who develop increased transaminase levels should be monitored with a second liver function evaluation to confirm the finding.
Bolesnike kod kojih se razviju povišene razine transaminaze treba pratiti s drugom procjenom jetrene funkcije kako bi se potvrdio nalaz.
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.
Sljedeću dozu zatim treba planirati za 4 tjedna od primijenjene injekcije kako bi se nastavilo s uobičajenim rasporedom primjene jedne doze svaka 4 tjedna.
Injection site reactions were also reported in clinical studies in other populations.
Reakcije na mjestu primjene injekcije bile su prijavljene i u kliničkim ispitivanjima na drugim populacijama.
Two-thirds of all patients had undergone prior surgery.
Dvije trećine svih bolesnika prethodno je bilo podvrgnuto kirurškom zahvatu.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Sav neiskorišteni lijek ili otpadni materijal treba ukloniti u skladu s lokalnim propisima.
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.
Na temelju farmakokinetičkih (PK) analiza populacije, procijenjeni CL/F bio je približno 4,8 do 6,5 litara/h za tipične bolesnike s Cushingovom bolešću, te približno 5,6 do 8,2 litara/h za tipične bolesnike s akromegalijom.
ATTENTION: Keep the plunger pressed and shake the vial moderately for a minimum of 30 seconds so that the powder is completely suspended.
OPREZ: Držite klip pritisnut i tresite bočicu umjereno najmanje 30 sekundi kako bi se prašak u potpunosti suspendirao.
At month 7, most patients demonstrated either improvement in or stable signs of Cushing's disease such as hirsuitism, striae, bruising and muscle strength.
U 7. mjesecu u većine je bolesnika bilo prisutno ili poboljšanje ili stabilizacija znakova Cushingove bolesti kao što su hirzutizam, strije, podljevi i mišićna snaga.
Cholecystitis includes cholecystitis acute and cholecystitis chronic.
Kolecistitis uključuje akutni kolecistitis i kronični kolecistitis.
One short fine sterile needle
Jedna kratka tanka sterilna igla
In addition, monitoring of FPG 4 weeks and HbA1c 3 months after the end of the treatment should be performed.
Nadalje, treba obavljati praćenje FPG-a četiri tjedna, a HbA1c 3 mjeseca nakon završetka liječenja.
Monitoring of liver function is recommended prior to treatment with pasireotide and after one, two, four, eight and twelve weeks during treatment.
Praćenje jetrene funkcije preporučuje se prije liječenja pasireotidom te nakon jedan, dva, četiri, osam i dvanaest tjedana tijekom liječenja.
If you interrupt your treatment with Signifor your cortisol level may increase again and your symptoms may come back.
Ako prekinete liječenje Signiforom, razina kortizola mogla bi Vam se ponovo povisiti i simptomi bi se mogli vratiti.
Grade 1 and 2 adverse reactions were reported in 57.4% of patients.
Nuspojave 1. i 2. stupnja bile su prijavljene kod 57,4% bolesnika.
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.
U ispitivanjima faze III, reakcije na mjestu primjene injekcije (npr. bol na mjestu primjene injekcije, nelagoda na mjestu primjene injekcije) bile su po težini uglavnom stupnja 1 ili 2.
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.
U ispitivanom dobnom rasponu od 18-73 godina, predviđa se da će površina ispod krivulje u stanju dinamičke ravnoteže za jedan interval doziranja od 12 sati (AUCss) biti od 86% do 111% površine tipičnog bolesnika starog 41 godinu.
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 treba oprezno koristiti te pažljivo odvagnuti omjer koristi i rizika u bolesnika kod kojih postoji značajan rizik od razvoja produženja QT intervala, kao što su bolesnici: - s prirođenim sindromom dugog QT intervala.
Take the sterile syringe and attach the needle to it.
Uzmite sterilnu štrcaljku i na nju pričvrstite iglu.
This may involve measuring the levels of cortisol in your blood or urine.
To bi moglo uključivati mjerenje razina kortizola u Vašoj krvi ili mokraći.
• calcium channel blockers (bepridil, verapamil, diltiazem)
• blokatori kalcijevih kanala (bepridil, verapamil, diltiazem),
In the event of documented hypocortisolism, temporary exogenous steroid (glucocorticoid) replacement therapy and/or dose reduction or interruption of Signifor therapy may be necessary.
U slučaju dokumentiranog hipokortizolizma možda će biti potrebna privremena egzogena nadomjesna terapija steroidima (glukokortikoidom) i/ili smanjenje ili prekid uzimanja terapije Signiforom.
Patients should receive instructions from the physician or a healthcare professional on how to inject Signifor subcutaneously.
Bolesnici trebaju dobiti upute od liječnika ili zdravstvenog radnika za supkutano ubrizgavanje Signifora.
The dose should not exceed 40 mg.
Doza ne smije premašiti 40 mg.
Each ampoule contains 1 ml of solution for injection.
Svaka ampula sadrži 1 ml otopine za injekciju.
6 ampoules.
6 ampula.
Following multiple monthly doses, pasireotide intramuscular use demonstrates approximately dose-proportional pharmacokinetic exposures in the dose range of 10 mg to 60 mg every 4 weeks.
Nakon višestrukih mjesečnih doza, pasireotid primijenjen intramuskularno pokazuje otprilike dozi proporcionalne farmakokinetičke izloženosti u rasponu doze od 10 mg do 60 mg svaka 4 tjedna.
The dose should not exceed 60 mg.
Doza ne smije premašiti 60 mg.
Concomitant administration of pasireotide and ciclosporin may require adjustment of the ciclosporin dose to maintain therapeutic levels.
Istodobna primjena pasireotida i ciklosporina mogla bi zahtijevati prilagođavanje doze ciklosporina kako bi se održale terapijske razine.
As a result, it reduces the symptoms of acromegaly, which include headache, increased sweating, numbness of the hands and feet, tiredness and joint pain.
Kao rezultat toga smanjuje simptome akromegalije, koji uključuju glavobolju, pojačano znojenje, utrnulost šaka i stopala, umor i bol u zglobovima.
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.
Ako je takav prelazak potreban, preporučuje se zadržati interval od barem 28 dana između zadnje intramuskularne injekcije i prve supkutane injekcije te započeti sa supkutanom injekcijom u dozi od 0,6 mg pasireotida dvaput na dan.
If you forget to use Signifor
Ako ste zaboravili primijeniti Signifor
The coloured dot on the top part marks the position of the breaking point on the neck of the ampoule.
Obojana točka na gornjem dijelu označava mjesto loma na vratu ampule.
Abdominal distension, vomiting
Abdominalna distenzija, povraćanje
Slowly release the skin fold and gently pull the needle out.
Polako otpustite kožu i lagano izvucite iglu.
Pancreatitis is a potential adverse reaction associated with the use of somatostatin analogues due to the association between cholelithiasis and acute pancreatitis.
Pankreatitis je potencijalna nuspojava povezana s uporabom analoga somatostatina zbog povezanosti između kolelitijaze i akutnog pankreatitisa.
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.
Poput prirodnih peptidnih hormona somatostatina-14 i somatostatina-28 (poznatih i kao faktor koji inhibira otpuštanje somatotropina [engl. somatotropin release inhibiting factor, SRIF]) i drugih analoga somatostatina, pasireotid vrši svoju farmakološku aktivnost putem vezivanja za somatostatinske receptore.
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.
Izloženost nevezanom pasireotidu u plazmi (AUCinf,u) bila je povećana u ispitanika s bubrežnim oštećenjem (blago: 33%, umjereno: 25%, teško: 99%, ESRD: 143%) u odnosu na kontrolne ispitanike.
A total of 198 patients were randomised to receive pasireotide intramuscular use 40 mg (n=65), pasireotide intramuscular use 60 mg (n=65) or active control (n=68).
Ukupno je 198 bolesnika bilo randomizirano na primanje pasireotida 40 mg intramuskularno (n=65), pasireotida 60 mg intramuskularno (n=65) ili aktivne kontrole (n=68).
INTERMEDIATE CARTON OF MULTIPACK (WITHOUT BLUE BOX)
MEĐUPAKIRANJE U VIŠESTRUKOM PAKIRANJU (BEZ PLAVOG OKVIRA)
Thereafter liver function should be monitored as clinically indicated.
Nakon toga jetrenu funkciju treba pratiti prema kliničkim indikacijama.
Pasireotide demonstrates low clearance (CL/F ~7.6 litres/h for healthy volunteers and ~3.8 litres/h for Cushing's disease patients).
Pasireotid pokazuje niski klirens (CL/F ~7,6 litara/h za zdrave dobrovoljce i ~3,8 litara/h za bolesnike s Cushingovom bolešću).
Cardiovascular related events
Događaji povezani s kardiovaskularnim sustavom
Ampoules should be opened just prior to administration, and any unused portion discarded.
Ampule treba otvoriti netom prije primjene, a neiskorišteni dio lijeka potrebno je baciti.
Paediatric population No studies have been performed in paediatric patients.
Pedijatrijska populacija Nisu provedena ispitivanja na pedijatrijskim bolesnicima.
If you interrupt your treatment with Signifor your symptoms may come back.
Ako prekinete liječenje Signiforom, simptomi bi Vam se mogli vratiti.
The patient should be evaluated for clinical benefit after the first month of treatment and periodically thereafter.
Potrebno je procijeniti kliničku korist za bolesnika nakon prvog mjeseca liječenja te periodički nakon toga.
• beta blockers (metoprolol, carteolol, propranolol, sotalol)
• beta blokatori (metoprolol, karteolol, propranolol, sotalol),
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).
Kod Cushingove bolesti je sigurnost intramuskularne formulacije procijenjena na temelju 150 bolesnika koji su primali pasireotid u ispitivanju G2304 faze III (medijan trajanja izloženosti: 57 tjedana).
CARTON OF UNIT PACK
KARTONSKA KUTIJA JEDINIČNOG PAKIRANJA
This means that it is injected through a short needle into the fatty tissue just under the skin.
To znači da se ubrizgava kroz kratku iglu u masno tkivo odmah ispod kože.
The reactions were most frequently reported as local pain, erythema, haematoma, haemorrhage and pruritus.
Reakcije su najčešće bile prijavljene kao lokalna bol, eritem, hematom, krvarenje i pruritus.
Store Signifor ampoules according to the storage conditions listed on the box.
Ampule Signifora čuvajte u skladu s uvjetima čuvanja koji su navedeni na kutiji.
prolongation (see section 4.5).
(vidjeti dio 4.5).