natgillin/translations-raw huggingface dataset:
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).
Višestruka pakiranja (samo jačine od 40 mg i 60 mg): svako višestruko pakiranje sadrži 3 međupakiranja, od kojih svako sadrži podložak s jednim setom za primjenu injekcije (jedna bočica te, u odvojenom zatvorenom dijelu, jedna napunjena štrcaljka, jedan nastavak za bočicu i jedna igla za injekciju sa zaštitnim mehanizmom).
Gently tap the syringe to remove any visible bubbles and expel them from the syringe.
Lagano kucnite po štrcaljki da uklonite vidljive mjehuriće ako ih ima i izbacite ih iz štrcaljke.
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.
Terapiju pasireotidom treba prekinuti ako bolesnik razvije žuticu ili druge znakove koji upućuju na klinički značajnu disfunkciju jetre, u slučaju održanog povišenja AST-a (aspartat aminotransferaze) ili ALT-a od 5 x GGN ili većeg, ili ako se povišenja ALT-a ili AST-a veća od 3 x GGN pojave istodobno s povišenjima bilirubina većima od 2 x GGN.
Nearly half of the patients had additional prior medical treatment for acromegaly other than somatostatin analogues.
Gotovo polovica bolesnika prethodno je primala terapiju lijekovima za akromegaliju koja nije uključivala analoge somatostatina.
The recommended initial dose is 0.6 mg pasireotide by subcutaneous injection twice a day.
Preporučena početna doza je 0,6 mg pasireotida supkutanom injekcijom dvaput na dan.
DO NOT USE if the medicine has expired or if the dose is incorrect.
Lijek NE KORISTITE ako mu je istekao rok valjanosti ili ako doza nije odgovarajuća.
The patients recovered without clinical sequelae and liver function test results returned to baseline values after discontinuation of treatment.
Bolesnici su se oporavili bez kliničkih posljedica, a rezultati testova jetrene funkcije vratili su se na početne vrijednosti nakon prekida liječenja.
Grade 3 adverse reactions were observed in 35.8% of patients and Grade 4 adverse reactions in 2.5% of patients.
Nuspojave 3. stupnja bile su uočene kod 35,8% bolesnika, a nuspojave 4. stupnja kod 2,5% bolesnika.
In medically naïve patients (study C2305), the mean absolute increase in FPG and HbA1c was similar at most of the time points for all patients treated with pasireotide intramuscular use irrespective of baseline values.
U bolesnika bez prethodne terapije lijekovima (ispitivanje C2305), srednje apsolutno povećanje FPG-a i HbA1c bilo je slično u većini vremenskih točaka za sve bolesnike liječene pasireotidom primijenjenim intramuskularno bez obzira na početne vrijednosti.
• metformin, liraglutide, vildagliptin, nateglinide (antidiabetic medicines).
• metformin, liraglutid, vildagliptin, nateglinid (antidijabetici).
Bradycardia has been reported with the use of pasireotide (see section 4.8).
Kod primjene pasireotida prijavljivana je bradikardija (vidjeti dio 4.8).
Careful monitoring is recommended in patients with cardiac disease and/or risk factors for bradycardia, such as history of clinically significant bradycardia or acute myocardial infarction, high-grade heart block, congestive heart failure (NYHA Class III or IV), unstable angina, sustained ventricular tachycardia, ventricular fibrillation.
Preporučuje se pažljivo praćenje kod bolesnika sa srčanom bolešću i/ili rizičnim čimbenicima za bradikardiju, kao što su klinički značajna bradikardija ili akutni infarkt miokarda u anamnezi, blok srca visokog stupnja, kongestivno zatajenje srca (NYHA klasa III ili IV), nestabilna angina, postojana ventrikularna tahikardija, ventrikularna fibrilacija.
If a dose of Signifor is missed, the next injection should be administered at the scheduled time.
Ako se propusti doza Signifora, sljedeću injekciju treba primijeniti u predviđeno vrijeme.
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.
Udio bolesnika sa smanjenjem volumena tumora većim od 20% u 12. mjesecu bio je 80,8% za pasireotid primijenjen intramuskularno te 77,4% za oktreotid primijenjen intramuskularno.
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.
Bolesnici su bili randomizirani u omjeru 1:1 u jednu od dvije terapijske skupine u svakoj od sljedeće dvije kategorije: 1) bolesnici koji su imali jednu ili više operacija hipofize, ali nisu primali terapiju lijekovima ili 2) de novo bolesnici s vidljivim adenomom hipofize na MRI-ju koji su odbili operaciju hipofize ili za koje je operacija hipofize bila kontraindicirana.
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.
U kliničkim ispitivanjima faze III u bolesnika s akromegalijom nisu utvrđene nikakve klinički značajne razlike u događajima produženja QT intervala između pasireotida primijenjenog intramuskularno i analoga somatostatina koji su bili ispitivani kao aktivni komparator.
Signifor may have a minor effect on the ability to drive and use machines, because some of the side effects you may experience while using Signifor, such as headache, dizziness and tiredness, may reduce your ability to drive and use machines safely.
Signifor može imati mali utjecaj na sposobnost upravljanja vozilima i rada sa strojevima zato što neke od nuspojava koje možete osjetiti dok primjenjujete Signifor, kao što su omaglica, glavobolja i umor, mogu smanjiti Vašu sposobnost da sigurno upravljate vozilima i strojevima.
No QTcF values >500 ms were observed in any of the pivotal studies.
Ni u jednom od ključnih ispitivanja nije bila opažena vrijednost QTcF-a >500 ms.
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).
Mjera primarnog ishoda djelotvornosti bila je ispunjena; postotak bolesnika koji su postigli biokemijsku kontrolu bio je 31,3% za pasireotid primijenjen intramuskularno te 19,2% za oktreotid primijenjen intramuskularno, što je pokazalo statistički značajan superioran rezultat u korist pasireotida primijenjenog intramuskularno (p-vrijednost = 0,007) (Tablica 4).
Anticipated pharmacokinetic interactions resulting in effects on pasireotide
Očekivane farmakokinetičke interakcije koje utječu na pasireotid
The study enrolled 162 patients with a baseline UFC >1.5 x ULN who were randomised in a 1:1 ratio to receive a subcutaneous dose of either 0.6 mg or 0.9 mg Signifor twice daily.
Ispitivanje je uključivalo 162 bolesnika s početnim UFC-om >1,5 x GGN koji su bili randomizirani u omjeru 1:1 na primjenu supkutane doze od 0,6 mg ili 0,9 mg Signifora dvaput na dan.
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.
Bolesnici su bili randomizirani u omjeru 1:1 na primanje početnih doza pasireotida od 10 mg ili 30 mg, uz mogućnost postupnog povećanja do maksimalne doze od 40 mg svakih 28 dana.
Monitoring for an effect on the QTc interval is advisable 21 days after the beginning of the treatment and as clinically indicated thereafter.
Savjetuje se praćenje učinka na QTc interval 21 dan nakon početka terapije te nakon toga u skladu s kliničkim indikacijama.
Fasting plasma glucose and HbA1c values generally decreased over the 28 days following pasireotide discontinuation but remained above baseline values.
Vrijednosti glukoze u plazmi natašte i HbA1c općenito su se smanjile tijekom 28 dana nakon prekida uzimanja pasireotida, ali ostala su iznad početnih vrijednosti.
Your doctor or nurse will inject Signifor.
Vaš liječnik ili medicinska sestra dat će Vam injekciju Signifora.
60 ampoules (10x6)
60 ampula (10x6)
If you accidentally use more Signifor than your doctor prescribed, immediately contact your doctor, nurse or pharmacist.
Ako slučajno primijenite više Signifora nego što Vam je liječnik propisao, odmah se obratite liječniku, medicinskoj sestri ili ljekarniku.
Powder: slightly yellowish to yellowish powder.
Prašak: blago žućkasti do žućkasti prašak.
Signifor solution for injection should be free of visible particles, clear and colourless.
Signifor otopina za injekciju treba biti bez vidljivih čestica, bistra i bezbojna.
Turn syringe and vial upside down, slowly pull the plunger back and draw the entire content from the vial into the syringe.
Preokrenite naopako štrcaljku i bočicu, polako povucite klip unatrag i izvucite cjelokupni sadržaj iz bočice u štrcaljku.
One Signifor ampoule
Jedna ampula Signifora
FPG and HbA1c increases were dose-dependent, and values generally decreased following pasireotide intramuscular use discontinuation but remained above baseline values.
Povećanja FPG-a i HbA1c bila su ovisna o dozi, a vrijednosti su se općenito smanjile nakon obustave primjene intramuskularnog pasireotida, ali su ostale iznad početnih vrijednosti.
Decreases were also demonstrated by the overall percentage change from baseline in mean and median mUFC levels at month 7 and 12.
Smanjenja su bila dokazana i ukupnim postotkom promjene od početnih vrijednosti u srednjim vrijednostima i medijanima mUFC-a u 7. i 12. mjesecu.
Signifor should only be administered by a trained healthcare professional.
Signifor smije primjenjivati samo educirani zdravstveni radnik.
Signifor is a medicine that contains the active substance pasireotide.
Signifor je lijek koji sadrži djelatnu tvar pasireotid.
Remove the plastic cap from the vial and clean the rubber stopper of the vial with an alcohol wipe.
Uklonite plastični zatvarač s bočice i očistite gumeni čep bočice alkoholnom maramicom.
The maximum recommended dose for these patients is 0.6 mg twice a day.
Najveća preporučena doza za te bolesnike je 0,6 mg dvaput na dan.
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.
Ako imate bolest jetre prije nego što započnete liječenje Signiforom, liječnik će možda htjeti da započnete liječenje dozom od jedne ampule Signifora 0,3 mg dvaput na dan.
Bradycardic medicinal products
Lijekovi protiv bradikardije
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.
Dvanaest mjeseci nakon ukrižene zamjene, postotak bolesnika koji su postigli biokemijsku kontrolu bio je 17,3% (14/81) za pasireotid primijenjen intramuskularno te 0% (0/38) za oktreotid primijenjen intramuskularno.
Hold the base of the ampoule in one hand.
Primite tijelo ampule jednom rukom.
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.
Signifor je dostupan u pakiranjima koja sadrže 6 ampula ili u višestrukim pakiranjima koja sadrže 18 (3 pakiranja po 6), 30 (5 pakiranja po 6) ili 60 (10 pakiranja po 6) ampula.
Episodes of torsade de pointes were not observed either in those studies or in clinical studies in other patient populations.
Epizode torsade de pointes nisu bile uočene ni u jednom od tih ispitivanja ili kliničkih ispitivanja s drugim populacijama bolesnika.
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).
Udio bolesnika koji su ili postigli mUFC ≤GGN ili smanjenje mUFC-a u odnosu na početnu vrijednost od najmanje 50% bio je 50,0% u skupini koja je primala 10 mg, te 56,6% u skupini koja je primala 30 mg (Tablica 5).
18 ampoules (3x6)
18 ampula (3x6)
Somatostatin receptors are expressed in many tissues, especially in neuroendocrine tumours in which hormones are excessively secreted, including ACTH in Cushing's disease.
Somatostatinski receptori izraženi su u mnogim tkivima, osobito u neuroendokrinim tumorima u kojima se prekomjerno izlučuju hormoni, uključujući ACTH u Cushingovoj bolesti.
Decreases in systolic and diastolic blood pressure and in body weight were observed in both dose groups at month 7.
Smanjenja u sistoličkom i dijastoličkom krvnom tlaku i tjelesnoj težini bila su uočena u 7. mjesecu u obje dozne skupine.
For instructions on reconstitution of the medicinal product before administration, see section 6.6.
Za uputu o razrjeđivanju lijeka prije primjene, vidjeti dio 6.6.
The primary efficacy endpoint was the proportion of patients with a reduction of mean GH level to <2.5 μg/l and the normalisation of IGF-1 to within normal limits (age and sex related) at month 12.
Mjera primarnog ishoda djelotvornosti bila je udio bolesnika sa smanjenjem srednje razine GH-a na <2,5 μg/l te normalizacijom IGF-1 do unutar normalnih granica (povezano s dobi i spolom) u 12. mjesecu.
Treatment with Signifor leads to rapid suppression of ACTH (adrenocorticotropic hormone) secretion in Cushing's disease patients.
Liječenje Signiforom vodi do brze supresije izlučivanja ACTH-a (adrenokortikotropnog hormona) u bolesnika s Cushingovom bolešću.
1 vial of powder
1 bočica praška
PK exposures had a slight correlation with body weight in the study with medical treatment naïve patients, but not in the study with inadequately controlled patients.
PK izloženosti imale su malu korelaciju s tjelesnom težinom u ispitivanju s bolesnicima koji nisu ranije primali terapiju lijekovima, ali ne u ispitivanju s neodgovarajuće kontroliranim bolesnicima.
Packs containing 6 ampoules or multipacks containing 18 (3 x 6), 30 (5 x 6) or 60 (10 x 6) ampoules.
Pakiranja koja sadrže 6 ampula ili višestruka pakiranja koja sadrže 18 (3 x 6), 30 (5 x 6) ili 60 (10 x 6) ampula.
Very common (may affect more than 1 in 10 people) - High level of sugar in the blood.
Vrlo često (mogu se javiti u više od 1 na 10 osoba) - Visoka razina šećera u krvi.
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).
U kliničkom ispitivanju u ispitanika s oštećenom funkcijom jetre (Child-Pugh A, B i C) pronađene su statistički značajne razlike u ispitanika s umjerenim i teškim oštećenjem jetre (Child-Pugh B i C).
The data described below reflect exposure of 162 Cushing's disease patients to Signifor in the phase III study.
Podaci opisani u nastavku odnose se na izloženost lijeku Signifor u 162 bolesnika s Cushingovom bolešću u ispitivanju faze III.
In study C2402, the only notable outlier was a QTcF value >480 ms in 1 patient in the pasireotide intramuscular use 40 mg group.
U ispitivanju C2402, jedina zamjetna stršeća vrijednost bila je vrijednost QTcF-a >480 ms u 1 bolesnika u skupini koja je primala 40 mg pasireotida intramuskularno.
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.
Bolesnici s početnim HbA1c ≥7% ili oni koji su uzimali antidijabetike prije randomizacije obično su imali više srednje promjene u glukozi u plazmi natašte i HbA1c u usporedbi s ostalim bolesnicima.
Signifor must be given only by deep intramuscular injection.
Signifor se smije primijeniti samo dubokom intramuskularnom injekcijom.
In the Cushing's disease study G2304, a QTcF value >480 ms was reported for 2 patients.
U ispitivanju u bolesnika s Cushingovom bolešću G2304, vrijednost QTcF-a >480 ms bila je prijavljena za 2 bolesnika.
Elevated glucose was the most frequently reported Grade 3 laboratory abnormality (23.2% of patients) in the phase III study in Cushing's disease patients.
Povišena glukoza bila je najčešće prijavljena laboratorijska abnormalnost 3. stupnja (23,2% bolesnika) u ispitivanju faze III na bolesnicima s Cushingovom bolešću.
Episodes of torsade de pointes were not observed in any clinical study with pasireotide.
Epizode torsade de pointes nisu bile uočene ni u jednom kliničkom ispitivanju pasireotida.
For further details on handling, see section 6.6.
Za više pojedinosti o rukovanju lijekom, vidjeti dio 6.6.
Pull the protective cover straight off the needle.
Uklonite zaštitni poklopac ravno s igle.
30 ampoules (5x6)
30 ampula (5x6)
In a randomised double-blinded mechanism study conducted in healthy volunteers, the development of hyperglycaemia with pasireotide administered as pasireotide subcutaneous use at doses of 0.6 and 0.9 mg twice a day was related to significant decreases in insulin secretion as well as incretin hormones (i.e. glucagon-like peptide-1 [GLP-1] and glucose-dependent insulinotropic polypeptide [GIP]).
U randomiziranom, dvostruko slijepom ispitivanju mehanizma djelovanja provedenom na zdravim dobrovoljcima, razvoj hiperglikemije s pasireotidom primijenjenim supkutano u dozama od 0,6 i 0,9 mg dvaput na dan bio je povezan sa značajnim smanjenjima u izlučivanju inzulina kao i inkretinskih hormona (tj. glukagonu nalik peptida-1 [GLP-1] i inzulinotropnog polipeptida ovisnog o glukozi [GIP]).
Remove the Signifor injection kit from refrigerated storage.
Izvadite Signifor set za primjenu injekcije iz hladnjaka.
Pasireotide binds with high affinity to four of the five hssts.
Pasireotid se visokim afinitetom veže za četiri od pet hsst-a.
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.
Izvadite set za primjenu injekcije iz hladnjaka i ostavite ga na sobnoj temperature najmanje 30 minuta prije rekonstitucije, ali ne dulje od 24 sata.
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.
Pri terapijskim dozama pasireotid također ne inhibira UGT1A1, OATP1B1 ili 1B3, OAT1 ili OAT3, OCT1 ili OCT2, P-gp, BCRP, MRP2 i BSEP.
Tap the syringe with your fingers to get rid of air bubbles.
Lagano kucnite štrcaljku prstima kako biste izbacili mjehuriće zraka.
Table 3 Percentage change in mean and median UFC levels per randomised dose group at month 6 and month 12 compared to baseline values
Tablica 3 Postotak promjene srednjih razina i medijana razina UFC-a po skupinama randomiziranim po dozama u 6. i 12. mjesecu u usporedbi s početnim vrijednostima
Pasireotide has been shown to prolong the QT interval on the ECG in two dedicated healthy volunteer studies.
Dokazano je da pasireotid produžuje QT interval na EKG-u u dva posebna ispitivanja na zdravim dobrovoljcima.
Recommended procedure: hold the ampoule in an upright position with the coloured dot facing away from you.
Preporučeni postupak: držite ampulu uspravno tako da je obojana točka okrenuta od Vas.
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.
Somatostatinski receptori izraženi su u mnogim tkivima, osobito u neuroendokrinim tumorima u kojima se prekomjerno izlučuju hormoni, uključujući GH kod akromegalije i ACTH kod Cushingove bolesti.
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.
Primarna mjera ishoda djelotvornosti bila je udio bolesnika u svakoj skupini koji su postigli normalizaciju srednjih 24-satnih razina UFC-a (UFC ≤GGN) nakon 6 mjeseci liječenja i kojima nije povećana doza (u odnosu na randomiziranu dozu) tijekom ovog razdoblja.
Included in the injection kit:
Uključeno u set za primjenu injekcije:
The primary efficacy endpoint was to compare the proportion of patients achieving biochemical control (defined as mean GH levels <2.5 μg/l and normalisation of sex- and age-adjusted IGF-1) at week 24 with pasireotide intramuscular use 40 mg or 60 mg versus continued treatment with active control (octreotide intramuscular use 30 mg or lanreotide deep subcutaneous injection 120 mg), separately.
Mjera primarnog ishoda djelotvornosti bila je usporediti udio bolesnika koji postignu biokemijsku kontrolu (definiranu kao srednje razine GH-a <2,5 μg/l i normalizacija IGF-1 prilagođenog za spol i dob) u 24. tjednu uz pasireotid 40 mg ili 60 mg primijenjen intramuskularno naspram kontinuiranog liječenja aktivnom kontrolom (oktreotid 30 mg primijenjen intramuskularno ili duboka supkutana injekcija 120 mg lanreotida), odvojeno.
In patients with poor glycaemic control, diabetes management and monitoring should be intensified prior to initiation and during pasireotide therapy.
U bolesnika sa slabom glikemijskom kontrolom, zbrinjavanje i praćenje šećerne bolesti treba intenzivirati prije započinjanja terapije pasireotidom te za njenog trajanja.
Mean FPG levels commonly increased within the first month of treatment with decreases and stabilisation observed in subsequent months.
Srednje razine FPG-a obično su se povisile unutar prvih mjesec dana liječenja, a smanjenja i stabilizacija opaženi su u narednim mjesecima.
Uncommon (may affect up to 1 in 100 people) - Low level of red blood cells (anaemia)
Manje često (mogu se javiti u manje od 1 na 100 osoba) - Niska razina crvenih krvnih stanica (anemija)
Your doctor or nurse will instruct you on how to inject yourself with Signifor.
Vaš liječnik ili medicinska sestra uputit će Vas kako da si sami ubrizgate Signifor.
The most common adverse reactions (incidence ≥1/10) from the pooled safety data from the phase III studies C2305 and C2402 were (in decreasing order): diarrhoea (most common in study C2305), cholelithiasis, hyperglycaemia (most common in study C2402) and diabetes mellitus.
Najčešće nuspojave (incidencija ≥1/10) iz objedinjenih sigurnosnih podataka iz ispitivanja faze III, C2305 i C2402, bile su (počevši od najčešćih): proljev (najčešći u ispitivanju C2305), kolelitijaza, hiperglikemija (najčešća u ispitivanju C2402) i šećerna bolest.
Mean fasting plasma glucose levels commonly increased within the first month of treatment, with decreases and stabilisation observed in subsequent months.
Srednje razine glukoze u plazmi natašte obično su se povećavale unutar prvih mjeseca dana liječenja, pri čemu su u narednim mjesecima bila uočena smanjenja i stabilizacija.
Slowly pull back the plunger to check that no blood vessel has been penetrated (reposition if a blood vessel has been penetrated).
Polako povucite klip kako biste provjerili da niste probili krvnu žilu (ubodite u drugo mjesto ako ste probili krvnu žilu).
At therapeutic dose levels pasireotide is also not an inhibitor of UGT1A1, OATP, 1B1 or 1B3, P-gp, BCRP, MRP2 and BSEP.
Pri terapijskim dozama pasireotid također ne inhibira UGT1A1, OATP, 1B1 ili 1B3, P-gp, BCRP, MRP2 i BSEP.
Maximum allowed dose was 60 mg for pasireotide intramuscular use and 30 mg for octreotide intramuscular use.
Najveća dopuštena doza bila je 60 mg za pasireotid primijenjen intramuskularno i 30 mg za oktreotid primijenjen intramuskularno.
Renal impairment No dose adjustment is required in patients with impaired renal function (see section 5.2).
Nije potrebno prilagođavanje doze u bolesnika s oštećenom funkcijom bubrega (vidjeti dio 5.2).