FrancophonIA/ELRC3.0 huggingface dataset:
English: Non-clinical safety data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, toxicity to reproduction and development.
Estonian: Farmakoloogilise ohutuse, korduvtoksilisuse, genotoksilisuse, kartsinogeensuse, reproduktsiooni- ja arengutoksilisuse mittekliinilised ohutusuuringud ei ole näidanud kahjulikku toimet inimesele.
English: - Inflammation of the gallbladder (cholecystitis).
Estonian: - Sapipõiepõletik (koletsüstiit).
English: Signifor 0.3 mg solution for injection Signifor 0.6 mg solution for injection Signifor 0.9 mg solution for injection
Estonian: Signifor 0,3 mg süstelahus Signifor 0,6 mg süstelahus Signifor 0,9 mg süstelahus
English: As the pharmacological activity of pasireotide mimics that of somatostatin, inhibition of pituitary hormones other than ACTH cannot be ruled out.
Estonian: Kuna pasireotiid imiteerib farmakoloogiliselt somatostatiini, siis ei saa välistada, et lisaks AKTH-le pärsib ravim ka teiste hüpofüüsihormoonide eritumist.
English: Multipack: 30 (5 packs of 6) ampoules.
Estonian: Mitmikpakend: 30 (5 karpi, millest igaüks sisaldab 6) ampulli.
English: The development of hyperglycaemia appears to be related to decreases in secretion of insulin and of incretin hormones (i.e. glucagon-like peptide-1 [GLP-1] and glucose-dependent insulinotropic polypeptide [GIP]).
Estonian: Hüperglükeemia teke on tõenäoliselt seotud insuliini ja inkretiinhormoonide (st glükagoonilaadne peptiid-1 [GLP-1] ja glükoosist sõltuv insulinotroopne polüpeptiid [GIP]) eritumise vähenemisega.
English: Put the cover back on the needle.
Estonian: Pange kate nõelale tagasi.
English: There are no clinical data available on switching from the intramuscular to the subcutaneous pasireotide formulation.
Estonian: Kliinilised andmed puuduvad patsientide üleviimise kohta lihasesiseselt ravimvormilt subkutaanselt manustatavale pasireotiidi ravimvormile.
English: Glycaemic status (fasting plasma glucose/haemoglobin A1c [FPG/HbA1c]) should be assessed prior to starting treatment with pasireotide.
Estonian: Enne ravi alustamist pasireotiidiga tuleb hinnata patsiendi glükeemilist seisundit (tühja kõhu plasma glükoositase/hemoglobiin A1c [FPG/HbA1c]).
English: Abdominal pain includes abdominal pain and abdominal pain upper.
Estonian: Kõhuvalu hulka kuuluvad kõhuvalu ja ülakõhuvalu.
English: Acromegaly The recommended initial dose for the treatment of acromegaly is 40 mg of pasireotide every 4 weeks.
Estonian: Akromegaalia Pasireotiidi soovituslik algannus akromegaalia raviks on 40 mg iga 4 nädala järel.
English: The recommended starting dose of Signifor in acromegaly is 40 mg every 4 weeks.
Estonian: Signifor'i soovitatav algannus on akromegaalia korral 40 mg iga 4 nädala järel.
English: Check the expiry date and the dose
Estonian: Kontrollige kõlblikkusaega ja annust
English: Diarrhoea, nausea, abdominal pain*
Estonian: Seedetrakti häired Kõhulahtisus, iiveldus, kõhuvalu*
English: The suppression of ACTH (adrenocorticotropic hormone) secretion can result in hypocortisolism in patients treated with Signifor.
Estonian: Signifor'i patsientidel võib adrenokortikotroopse hormooni (AKTH) eritumise pärssimine esile kutsuda hüpokortisolismi.
English: Very common (may affect more than 1 in 10 people) - Diarrhoea - Nausea - Abdominal pain - Fatigue
Estonian: Väga sage (võib esineda rohkem kui 1 inimesel 10-st) - Kõhulahtisus - Iiveldus - Kõhuvalu - Väsimus
English: Clinical monitoring of heart rate, notably at the beginning of treatment, is recommended in patients receiving pasireotide concomitantly with bradycardic medicinal products, such as beta blockers (e.g. metoprolol, carteolol, propranolol, sotalol), acetylcholinesterase inhibitors (e.g. rivastigmine, physostigmine), certain calcium channel blockers (e.g. verapamil, diltiazem, bepridil), certain antiarrhythmics (see also section 4.4).
Estonian: Patsientidel, kes saavad pasireotiidi samaaegselt bradükardiliste ravimitega nagu näiteks β-blokaatorid (nt metoprolool, karteolool, propranolool, sotalool), atsetüülkoliinesteraasi inhibiitorid (nt rivastigmiin, füsostigmiin), teatud kaltsiumikanali blokaatorid (nt verapamiil, diltiaseem, bepridiil) ja teatud antiarütmikumid, on eriti ravi alguses soovitatav jälgida südame löögisagedust (vt ka lõik 4.4).
English: Step 5:
Estonian: 5. samm:
English: At month 7, most patients demonstrated either improvement in or stable signs of Cushing's disease such as hirsuitism, striae, bruising and muscle strength.
Estonian: 7. kuul olid Cushingi tõve nähud (nagu hirsutism, striiad, verevalumid ja lihasjõud) enamikel patsientidel kas paranenud või püsisid muutumatuna.
English: - The other ingredients are: - In the powder: poly(D,L-lactide-co-glycolide) (50-60:40-50),
Estonian: - Teised koostisosad on: Pulber: polü(D,L-laktiidkoglükoliid) (50-60:40-50), polü(D,L-laktiidkoglükoliid)
English: Studies in rats have shown effects on female reproductive parameters (see section 5.3).
Estonian: Rottidel teostatud uuringutes on täheldatud toimet emaste rottide reproduktiivnäitajatele (vt lõik 5.3).
English: Step 7
Estonian: Samm 7
English: At therapeutic dose levels pasireotide is also not an inhibitor of UGT1A1, OATP, 1B1 or 1B3, P-gp, BCRP, MRP2 and BSEP.
Estonian: Terapeutilistes annustes ei ole pasireotiid ka UGT1A1 (uridiindifosfaatglükuronüültransferaas), OATP 1B1 ega 1B3, P-gp, BCRP, MRP2 (multiresistentsusega seotud proteiin 2) ega BSEP (sapisoola eksportpump) inhibiitor.
English: Transient elevations in liver enzymes have been reported with the use of somatostatin analogues and were also observed in patients receiving pasireotide in clinical studies.
Estonian: Somatostatiini analoogide kasutamisel on registreeritud maksaensüümide aktiivsuse lühiajalist tõusu, mida täheldati ka patsientidel, kes manustasid kliinilistes uuringutes pasireotiidi.
English: Step 9:
Estonian: 9. samm:
English: Step 3
Estonian: Samm 3
English: The most common adverse reactions (incidence ≥1/10) in the phase III study G2304 were hyperglycaemia, diarrhoea, cholelithiasis and diabetes mellitus.
Estonian: III faasi uuringus G2304 olid kõige sagedamad kõrvaltoimed (esinemissagedus ≥ 1/10) hüperglükeemia, kõhulahtisus, kolelitiaas ja suhkurtõbi.
English: Signifor 0.9 mg solution for injection EU/1/12/753/009-0012
Estonian: Signifor 0,9 mg süstelahus EU/1/12/753/009-0012
English: your doctor will monitor your coagulation parameters and may adjust your anticoagulant dose.
Estonian: Arst võib mõõta teie veresuhkrutaset ja määrata teile diabeediravi või kohandada selle annust.
English: Step 4
Estonian: Samm 4
English: Step 2:
Estonian: 2. samm:
English: Fatigue includes fatigue and asthenia.
Estonian: Koletsüstiidi hulka kuulub äge koletsüstiit.Väsimuse hulka kuuluvad väsimus ja asteenia.
English: In acromegaly patients, gastrointestinal disorders were less frequent in inadequately controlled patients compared to medically naïve patients.
Estonian: Seedetrakti häireid esines vähem akromegaaliaga patsientidel, kellel seisund ei olnud eelnevalt kontrolli all, võrreldes ravi mittesaanud patsientidega.
English: Powder and solvent for suspension for injection (powder for injection).
Estonian: Süstesuspensiooni pulber ja lahusti (süstesuspensiooni pulber).
English: 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.
Estonian: Kui üleviimine on vajalik, on soovitatavaks algannuseks Cushingi tõve korral 10 mg pasireotiidi sügava lihasesisese süstena iga nelja nädala tagant.
English: Diarrhoea, abdominal pain, nausea
Estonian: Seedetrakti häired Diarröa, kõhuvalu, iiveldus
English: Signifor 0.6 mg solution for injection EU/1/12/753/005-008
Estonian: Signifor 0,6 mg süstelahus EU/1/12/753/005-008
English: Getting started
Estonian: Alustamine
English: Multipack: 3 packs of 1 injection kit
Estonian: Mitmikpakend: 3 karpi ja 1 süstevahendi komplekt.
English: Decreases in systolic and diastolic blood pressure and in body weight were observed in both dose groups at month 7.
Estonian: 7. kuul täheldati mõlemas annuserühmas süstoolse ja diastoolse vererõhu ning kehakaalu langust.
English: The percentage of patients who had mean GH values
Estonian: Patsientide hulk protsentides, kellel esines:
English: In the Cushing's disease study G2304, a QTcF value >480 ms was reported for 2 patients.
Estonian: Cushingi tõve uuringus C2304 oli 2 patsiendil QTcF väärtus >480 ms. Kesksetes uuringutes ei olnud ühelgi patsiendil QTcF väärtus >500 ms.
English: You may experience yellowing of the skin, dark urine,
Estonian: Teil võib esineda naha kollakaks muutumine, tume uriin, hele väljaheide ja sügelus.
English: Step 4:
Estonian: 4. samm:
English: Step 1:
Estonian: 1. samm:
English: Available data in rats in which pasireotide was administered via the subcutaneous route have shown excretion of pasireotide in milk (see section 5.3).
Estonian: Olemasolevad andmed rottidel subkutaanse pasireotiidiga on näidanud, et pasireotiid eritub piima (vt lõik 5.3).
English: CARTON OF UNIT PACK
Estonian: ÜKSIKPAKENDI PAPPKARP
English: 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).
Estonian: 7. kuul saavutas mUFC ravivastuse 41,9% ja 40,8% patsientidest, kes randomiseeriti saama algannusena vastavalt 10 mg ja 30 mg. Patsientide protsent, kes saavutasid kas mUFC ≤ ULN või mUFC vähenemise vähemalt 50% võrreldes algväärtusega, oli 10 mg annuserühmas 50,0% ja 30 mg annuserühmas 56,6% (tabel 5).
English: 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.
Estonian: Süstekoha reaktsioonide hulka kuuluvad valu süstekohas, sõlm süstekohas, ebamugavustunne süstekohas, verevalum süstekohas, kihelus süstekohas, süstekoha reaktsioon, süstekoha ülitundlikkus ja paistetus süstekohas.
English: Mild transient elevations in aminotransferases are commonly observed in patients treated with pasireotide.
Estonian: Pasireotiidiga ravitud patsientidel täheldati sageli kerget mööduvat aminotransferaaside aktiivsuse suurenemist.
English: Step 3:
Estonian: 3. samm:
English: 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.
Estonian: FK plasmakontsentratsioonil oli mõningane seos kehakaaluga eelnevalt ravi mittesaanud patsientide ja ebapiisava kontrolli saavutanud patsientide puhul.
English: No clinical studies in subjects with liver impairment have been performed with pasireotide intramuscular use.
Estonian: Maksakahjustusega patsientidel ei ole intramuskulaarse pasireotiidiga läbi viidud kliinilisi uuringuid.
English: Signifor 60 mg powder and solvent for suspension for injection EU/1/12/753/016-017
Estonian: Signifor 60 mg süstesuspensiooni pulber ja lahusti EU/1/12/753/016-017
English: It is also used to treat Cushing's disease in adult patients for whom surgery is not an option or for whom surgery has failed.
Estonian: Seda kasutatakse ka Cushingi tõve ravimiseks täiskasvanutel, kellel kirurgiline ravi ei ole võimalik või kellel kirurgiline ravi on ebaõnnestunud.
English: 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.
Estonian: Tervetel vabatahtlikel imendus pasireotiid kiiresti ja maksimaalne plasmakontsentratsioon saavutati 0,25…0,5 tunniga.
English: The recommended initial dose is 0.6 mg pasireotide by subcutaneous injection twice a day.
Estonian: Pasireotiidi soovituslik algannus on 0,6 mg manustatuna kaks korda ööpäevas subkutaanse süstina.
English: Signifor 20 mg: each vial contains 20 mg pasireotide (as pasireotide pamoate).
Estonian: Signifor 20 mg: Üks viaal sisaldab 20 mg pasireotiidi (pasireotiidpamoaadina).
English: Signifor solution for injection is filled in a break-off ampoule.
Estonian: Signifor süstelahus on pakendatud murtava kaelaga ampulli.
English: The recommended initial dose for the treatment of Cushing's disease is 10 mg of pasireotide by deep intramuscular injection every 4 weeks.
Estonian: Pasireotiidi soovituslik algannus Cushingi tõve raviks on 10 mg sügava lihasesisese süstena iga 4 nädala järel.
English: You may experience excessive thirst, high urine output,
Estonian: Teil võib esineda ülemäärane janu, sage urineerimine, söögiisu suurenemine ja kaalulangus, väsimus.
English: Pasireotide
Estonian: Pasireotiid
English: Studies in rats in which pasireotide was administered via the subcutaneous route have shown effects on female reproductive parameters (see section 5.3).
Estonian: Rottidel teostatud uuringutes subkutaanse pasireotiidiga on täheldatud toimet emaste rottide reproduktiivnäitajatele (vt lõik 5.3).
English: Remove the cap from the syringe pre-filled with solvent and screw the syringe onto the vial adapter.
Estonian: Eemaldage kork lahustiga süstlilt ja keerake süstal viaaliadapteri külge.
English: Signifor 20 mg powder and solvent for suspension for injection One vial contains 20 mg pasireotide (as pasireotide pamoate).
Estonian: Signifor 20 mg süstesuspensiooni pulber ja lahusti Üks viaal sisaldab 20 mg pasireotiidi (pasireotiidpamoaadina) (Pasireotidum).
English: Hepatic impairment Dose adjustment is not required in patients with mildly impaired hepatic function (Child Pugh A).
Estonian: Kerge maksakahjustusega (Child Pugh klass A) patsientidel ei ole annuse kohandamine vajalik.
English: Carmellose sodium Mannitol
Estonian: Mannitool Viinhape
English: A baseline ECG is recommended prior to initiating therapy with Signifor.
Estonian: Enne ravi alustamist Signifor'iga on soovitatav teostada ravieelne EKG.
English: Signifor 10 mg: each vial contains 10 mg pasireotide (as pasireotide pamoate).
Estonian: Signifor 10 mg: Üks viaal sisaldab 10 mg pasireotiidi (pasireotiidpamoaadina).
English: Signifor 0.3 mg solution for injection EU/1/12/753/001-004
Estonian: Signifor 0,3 mg süstelahus EU/1/12/753/001-004
English: Signifor 0.9 mg injection pasireotide
Estonian: Signifor 0,9 mg süstelahus Pasireotidum
English: Signifor 60 mg: each vial contains 60 mg pasireotide (as pasireotide pamoate).
Estonian: Signifor 60 mg: Üks viaal sisaldab 60 mg pasireotiidi (pasireotiidpamoaadina).
English: Monitoring of liver enzymes is recommended before and during treatment with Signifor (see section 4.4), as clinically appropriate.
Estonian: Enne ravi alustamist Signifor'iga ja ravi ajal on soovitatav mõõta maksafunktsiooni näitajaid vastavalt kliinilisele vajadusele (vt lõik 4.4).
English: The usual starting dose of Signifor in Cushing's disease is 10 mg every 4 weeks.
Estonian: Signifor'i tavaline algannus on Cushingi tõve korral 10 mg iga 4 nädala järel.
English: Glucose metabolism disorders
Estonian: Glükoosi ainevahetuse häired
English: Step 7:
Estonian: 7. samm:
English: Step 6:
Estonian: 6. samm:
English: One vial contains 20 mg pasireotide (as pasireotide pamoate).
Estonian: Üks viaal sisaldab 20 mg pasireotiidi (pasireotiidpamoaadina).
English: Signifor 30 mg: each vial contains 30 mg pasireotide (as pasireotide pamoate).
Estonian: Signifor 30 mg: Üks viaal sisaldab 30 mg pasireotiidi (pasireotiidpamoaadina).
English: Especially, tell your doctor if you are using: - medicines used in organ transplantation to reduce the activity of the immune system
Estonian: Kindlasti rääkige oma arstile, kui te kasutate: - immuunsüsteemi aktiivsust pärssivad ravimid, mida kasutatakse elundi siirdamise korral (tsüklosporiin); - ravimid, mis on mõeldud liiga kõrge (nagu suhkurtõve korral) või madala (hüpoglükeemia) veresuhkrutaseme ravimiseks, näiteks:
English: Signifor 40 mg powder and solvent for suspension for injection EU/1/12/753/014-015
Estonian: Signifor 40 mg süstesuspensiooni pulber ja lahusti EU/1/12/753/014-015
English: Signifor is to be administered subcutaneously by self injection.
Estonian: Signifor'i peab patsient endale manustama subkutaanse süstimise teel.
English: Signifor 0.6 mg injection pasireotide
Estonian: Signifor 0,6 mg süstelahus Pasireotidum
English: Signifor 20 mg is available in unit packs containing one vial of powder with 20 mg pasireotide and one pre-filled syringe with 2 ml solvent.
Estonian: Signifor 20 mg on saadaval üksikpakendis, mis sisaldab ühte 20 mg pulbriviaali ja ühte süstlit 2 ml lahustiga.
English: Hyperglycaemia and, less frequently, hypoglycaemia, were observed in subjects participating in clinical studies with pasireotide (see section 4.8).
Estonian: Pasireotiidi kliinilistes uuringutes osalenud isikutel täheldati hüperglükeemiat ja harvem hüpoglükeemiat (vt lõik 4.8).
English: Solvent: colourless pre-filled syringe (glass) with front and plunger stopper (chlorobutyl rubber), containing 2 ml solvent.
Estonian: Lahusti: (klorobutüülkummist) varbkolvi korgiga värvitu süstel (klaas) 2 ml lahustiga.
English: Signifor 60 mg powder and solvent for suspension for injection One vial contains 60 mg pasireotide (as pasireotide pamoate).
Estonian: Signifor 60 mg süstesuspensiooni pulber ja lahusti Üks viaal sisaldab 60 mg pasireotiidi (pasireotiidpamoaadina) (Pasireotidum).
English: A total of 201 Cushing's disease patients received Signifor in phase II and III studies.
Estonian: II ja III faasi uuringutes manustasid Signifor'i kokku 201 Cushingi tõvega patsienti.
English: Decreases in sitting systolic and diastolic blood pressure, body mass index (BMI) and total cholesterol were observed in both dose groups at month 6.
Estonian: Mõlemas annuserühmas täheldati 6. kuul istuvas asendis mõõdetud süstoolse ja diastoolse vererõhu, kehamassiindeksi ja üldkolesterooli taseme alanemist.
English: It is used to treat Cushing's disease in adult patients for whom surgery is not an option or for whom surgery has failed.
Estonian: Seda kasutatakse Cushingi tõve ravimiseks täiskasvanutel, kellel kirurgiline ravi ei ole võimalik või kellel kirurgiline ravi on ebaõnnestunud.
English: The elevations of fasting plasma glucose and HbA1c observed with pasireotide intramuscular use treatment are reversible after discontinuation.
Estonian: Pärast ravi katkestamist on intramuskulaarselt pasireotiidi saanud patsientide paastuglükoosi ja HbA1c taseme tõus pöörduv.
English: Transient elevations in liver enzymes have been reported with the use of somatostatin analogues and were also observed in healthy subjects and patients receiving pasireotide in clinical studies.
Estonian: Somatostatiini analoogide kasutamisel on registreeritud maksaensüümide aktiivsuse lühiajalist tõusu, mida täheldati tervetel vabatahtlikel ja patsientidel, kes manustasid kliinilistes uuringutes pasireotiidi.
English: One vial contains 10 mg pasireotide (as pasireotide pamoate).
Estonian: Üks viaal sisaldab 10 mg pasireotiidi (pasireotiidpamoaadina).
English: One vial contains 60 mg pasireotide (as pasireotide pamoate).
Estonian: Üks viaal sisaldab 60 mg pasireotiidi (pasireotiidpamoaadina).
English: Age has been found to be a covariate in the population pharmacokinetic analysis of Cushing's disease patients.
Estonian: Cushingi tõvega patsientide populatsiooni farmakokineetilises analüüsis leiti, et vanus on üks muutujatest.
English: Signifor 30 mg powder and solvent for suspension for injection One vial contains 30 mg pasireotide (as pasireotide pamoate).
Estonian: Signifor 30 mg süstesuspensiooni pulber ja lahusti Üks viaal sisaldab 30 mg pasireotiidi (pasireotiidpamoaadina) (Pasireotidum).
English: It is unknown whether pasireotide is excreted in human milk.
Estonian: Ei ole teada, kas pasireotiid/metaboliidid erituvad rinnapiima.
English: Studies in animals in which pasireotide was administered via the subcutaneous route have shown reproductive toxicity (see section 5.3).
Estonian: Loomkatsed subkutaanse pasireotiidiga on näidanud kahjulikku toimet reproduktiivsusele (vt lõik 5.3).
English: One vial contains 30 mg pasireotide (as pasireotide pamoate).
Estonian: Üks viaal sisaldab 30 mg pasireotiidi (pasireotiidpamoaadina).
English: Signifor 10 mg powder and solvent for suspension for injection One vial contains 10 mg pasireotide (as pasireotide pamoate).
Estonian: Signifor 10 mg süstesuspensiooni pulber ja lahusti Üks viaal sisaldab 10 mg pasireotiidi (pasireotiidpamoaadina) (Pasireotidum).
English: More cases of discontinuation and a higher reporting rate of severe adverse events due to hyperglycaemia were reported in patients treated with the dose of 0.9 mg twice daily.
Estonian: Patsientidel, keda raviti päevase annusega 0,9 mg kaks korda päevas, esines rohkem ravi katkestamise juhte ja teatati rohkem hüperglükeemiaga seotud tõsistest kõrvaltoimetest.
English: Signifor 20 mg powder for injection pasireotide
Estonian: Signifor 20 mg süstesuspensiooni pulber ja lahusti Pasireotidum
English: Signifor 60 mg is available in unit packs containing one vial of powder with 60 mg pasireotide and one pre-filled syringe with 2 ml solvent.
Estonian: Signifor 60 mg on saadaval üksikpakendis, mis sisaldab ühte 60 mg pulbriviaali ja ühte süstlit 2 ml lahustiga.
English: Signifor 40 mg powder and solvent for suspension for injection One vial contains 40 mg pasireotide (as pasireotide pamoate).
Estonian: Signifor 40 mg süstesuspensiooni pulber ja lahusti Üks viaal sisaldab 40 mg pasireotiidi (pasireotiidpamoaadina) (Pasireotidum).
English: INSTRUCTIONS FOR USE OF SIGNIFOR SOLUTION FOR INJECTION
Estonian: SIGNIFOR SÜSTELAHUSE KASUTAMISJUHEND
English: Signifor 0.3 mg injection pasireotide
Estonian: Signifor 0,3 mg süstelahus Pasireotidum
English: Signifor 40 mg: each vial contains 40 mg pasireotide (as pasireotide pamoate).
Estonian: Signifor 40 mg: Üks viaal sisaldab 40 mg pasireotiidi (pasireotiidpamoaadina).
English: Glucose metabolism
Estonian: Glükoosi ainevahetus
English: How to store Signifor
Estonian: Kuidas Signifor'i säilitada
English: Signifor 30 mg is available in unit packs containing one vial of powder with 30 mg pasireotide and one pre filled syringe with 2 ml solvent.
Estonian: Signifor 30 mg on saadaval üksikpakendis, mis sisaldab ühte 30 mg pulbriviaali ja ühte süstlit 2 ml lahustiga.
English: Pasireotide has been shown to prolong the QT interval on the ECG in two dedicated healthy volunteer studies.
Estonian: Kahes erinevas tervetel vabatahtlikel teostatud uuringus näidati, et pasireotiid pikendas QT-intervalli EKG-s.
English: Body weight has been found to be a covariate in the population pharmacokinetic analysis of Cushing's disease patients.
Estonian: Cushingi tõvega patsientide populatsiooni farmakokineetilises analüüsis leiti, et kehakaal on üks muutujatest.
English: Prepare the injection site with an alcohol wipe.
Estonian: Puhastage süstekoht alkoholitampooniga.
English: Signifor 10 mg is available in unit packs containing one vial of powder with 10 mg pasireotide and one pre filled syringe with 2 ml solvent.
Estonian: Signifor 10 mg on saadaval üksikpakendis, mis sisaldab ühte 10 mg pulbriviaali ja ühte süstlit 2 ml lahustiga.
English: Signifor 10 mg powder and solvent for suspension for injection EU/1/12/753/018
Estonian: Signifor 10 mg süstesuspensiooni pulber ja lahusti EU/1/12/753/018
English: Signifor 20 mg powder and solvent for suspension for injection EU/1/12/753/013
Estonian: Signifor 20 mg süstesuspensiooni pulber ja lahusti EU/1/12/753/013
English: Signifor 40 mg is available in unit packs containing one vial of powder with 40 mg pasireotide and one pre-filled syringe with 2 ml solvent.
Estonian: Signifor 40 mg on saadaval üksikpakendis, mis sisaldab ühte 40 mg pulbriviaali ja ühte süstlit 2 ml lahustiga.
English: Signifor 0.9 mg: One ampoule of 1 ml solution contains 0.9 mg pasireotide (as pasireotide diaspartate).
Estonian: Signifor 0,9 mg: Üks 1 ml ampull sisaldab 0,9 mg pasireotiidi (pasireotiiddiaspartaadina).
English: Signifor 10 mg powder for injection pasireotide
Estonian: Signifor 10 mg süstesuspensiooni pulber ja lahusti Pasireotidum
English: Doses should not be doubled to make up for a missed dose.
Estonian: Kui annuse manustamine ununes, ei tohi kasutada kahekordset annust.