FrancophonIA/ELRC3.0 huggingface dataset:
English: In the acromegaly studies, the events were comparable between pasireotide intramuscular use and octreotide intramuscular use treated patients, and were less frequent in inadequately controlled patients compared to medically naïve patients.
Icelandic: á æsavexti voru tilvik sambærileg á milli sjúklinga sem fengu meðferð með pasireotidi í vöðva og octreotidi í vöðva og voru sjaldgæfari hjá sjúklingum sem ekki höfðu náð fullnægjandi stjórn á sjúkdómnum samanborið við sjúklinga sem ekki höfðu áður fengið lyfjameðferð.
English: Do not use Signifor if the solution is not clear or contains particles.
Icelandic: Signifor ef lausnin er ekki tær eða ef hún inniheldur agnir.
English: Single use.
Icelandic: Ekki nota
English: Dose reductions or discontinuation of treatment with pasireotide due to hyperglycaemia were infrequent in clinical studies with pasireotide.
Icelandic: Sjaldan þurfti að minnka skammta eða hætta meðferð með pasireotidi vegna blóðsykurshækkunar í klínískum rannsóknum á pasireotidi.
English: The development of hyperglycaemia appears to be related to decreases in secretion of insulin (particularly in the post-dose period) and of incretin hormones (i.e. glucagon-like peptide-1 [GLP-1] and glucose-dependent insulinotropic polypeptide [GIP]).
Icelandic: Blóðsykurshækkunin virðist tengjast minni seytingu insúlíns (einkum eftir að skammturinn hefur verið gefinn) og inkretín hormóna (þ.e. glúkagon-líku peptíði-1
English: Glycosylated haemoglobin increased
Icelandic: Aukning á sykurtengdu hemóglóbíni
English: Studies in rats in which pasireotide was administered via the subcutaneous route have shown effects on female reproductive parameters (see section 5.3).
Icelandic: Rannsóknir hjá rottum, þegar pasireotid er gefið undir húð, hafa sýnt áhrif á frjósemisstuðla hjá kvendýrum (sjá kafla 5.3).
English: Acromegaly is caused by a type of tumour called a pituitary adenoma which develops in the pituitary gland at the base of the brain.
Icelandic: Æsavöxtur er af völdum æxlis sem kallast kirtilæxli í heiladingli og myndast í heiladingli sem er neðan á heila.
English: The coloured dot on the top part marks the position of the breaking point on the neck of the ampoule.
Icelandic: Staðurinn á hálsi lykjunnar þar sem brjóta á lykjuna er merktur með lituðum depli á efri hluta hennar.
English: QT prolongation
Icelandic: Lenging QT bils
English: In acromegaly patients, gastrointestinal disorders were less frequent in inadequately controlled patients compared to medically naïve patients.
Icelandic: Hjá sjúklingum með æsavöxt voru meltingarfærakvillar sjaldgæfari hjá sjúklingum sem ekki höfðu náð fullnægjandi stjórn á sjúkdómnum samanborið við sjúklinga sem ekki höfðu áður fengið lyfjameðferð.
English: Signifor 20 mg powder and solvent for suspension for injection One vial contains 20 mg pasireotide (as pasireotide pamoate).
Icelandic: Signifor 20 mg stungulyfsstofn og leysir, dreifa Eitt hettuglas inniheldur 20 mg af pasireotidi (sem pasireotid pamoat).
English: Pasireotide is a cyclohexapeptide, injectable somatostatin analogue.
Icelandic: Pasireotid er cyclohexapeptíð somatostatin hliðstæða sem hægt er að gefa með inndælingu.
English: Each ampoule contains 1 ml of solution for injection.
Icelandic: Hver lykja inniheldur 1 ml af stungulyfi, lausn.
English: The recommended starting dose of Signifor in acromegaly is 40 mg every 4 weeks.
Icelandic: Ráðlagður upphafsskammtur af Signifor við æsavexti er 40 mg á 4 vikna fresti.
English: Pasireotide binds with high affinity to four of the five hssts.
Icelandic: Pasireotid binst fjórum af fimm hsst viðtökum með mikilli sækni.
English: 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.
Icelandic: Mælt er með nánu eftirliti með sjúklingum með hjartasjúkdóma og/eða áhættuþætti hægsláttar, svo sem sögu um klínískt marktækan hægslátt eða brátt hjartadrep, leiðslurof í hjarta á háu stigi, hjartabilun (NYHA flokkur III eða IV), hvikula hjartaöng, viðvarandi sleglahraðslátt eða sleglatif.
English: All analyses were conducted based on the randomised dose groups.
Icelandic: Allar greiningar voru gerðar á grundvelli slembiraðaðra skammtahópa.
English: Acromegaly The recommended initial dose for the treatment of acromegaly is 40 mg of pasireotide every 4 weeks.
Icelandic: Æsavöxtur Ráðlagður upphafsskammtur fyrir meðferð við æsavexti er 40 mg af pasireotidi á 4 vikna fresti.
English: Age has been found to be a covariate in the population pharmacokinetic analysis of Cushing's disease patients.
Icelandic: Komið hefur í ljós að aldur er skýribreyta (covariate) í greiningunni á lyfjahvörfum hjá mismunandi hópum sjúklinga með Cushings sjúkdóm.
English: Available data in rats have shown excretion of pasireotide in milk (see section 5.3).
Icelandic: Fyrirliggjandi upplýsingar hafa sýnt að pasireotid skilst út í móðurmjólk hjá rottum (sjá kafla 5.3).
English: Injection site reactions were reported in 13.6% of patients enrolled in the phase III study in Cushing's disease.
Icelandic: Greint var frá viðbrögðum á stungustað hjá 13,6% sjúklinga sem tóku þátt í III.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING
Icelandic: Lýsing á útliti Signifor og pakkningastærðir
English: Table 5 Key results - phase III study in Cushing's disease patients (intramuscular formulation)
Icelandic: stigs rannsókn hjá sjúklingum með Cushings sjúkdóm (samsetning til notkunar í vöðva)
English: The elevations were mostly asymptomatic, of low grade and reversible with continued treatment.
Icelandic: Hækkanirnar voru yfirleitt einkennalausar, vægar og gengu til baka þegar meðferð var haldið áfram.
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.
Icelandic: Signifor 20 mg er fáanlegt í stakpakkningum sem innihalda eitt hettuglas með stungulyfsstofni með 20 mg af pasireotidi og eina áfyllta sprautu með 2 ml af leysi.
English: Signifor should be administered using sterile disposable syringes and injection needles.
Icelandic: Signifor á að gefa með dauðhreinsuðum einnota sprautum og nálum.
English: The European Medicines Agency has waived the obligation to submit the results of studies with Signifor in all subsets of the paediatric population in acromegaly and pituitary gigantism, and in pituitary dependant Cushing's disease, overproduction of pituitary ACTH and pituitary dependant hyperadrenocorticism (see section 4.2 for information on paediatric use).
Icelandic: á Signifor hjá öllum undirhópum barna við æsavexti og dingulrisavexti (pituitary gigantism) og við Cushings sjúkdómi sem tengist heiladingli, offramleiðslu á ACTH í heiladingli og ofvirkni í nýrnahettum sem er háð heiladingulsstarfsemi (sjá upplýsingar í kafla 4.2 um notkun handa börnum).
English: Common (may affect up to 1 in 10 people) - Tiredness, fatigue, pale skin (signs of low level of red blood cells) - Loss of appetite - Headache - Bloating - Vomiting - Dizziness - Pain, discomfort, pruritis and swelling at the injection site - Change in liver function test results
Icelandic: - Uppþemba - Uppköst - Sundl - Verkur, óþægindi, kláði og þroti á stungustað - Breytingar á niðurstöðum úr rannsóknum á lifrarstarfsemi - Óeðlilegar niðurstöður blóðrannsókna (merki um mikið magn af kreatínfosfókínasa, sykruðum blóðrauða, lípasa í blóði) - Hárlos
English: Pasireotide has been shown to prolong the QT interval on the ECG in two dedicated healthy volunteer studies.
Icelandic: Komið hefur í ljós að pasireotid lengdi QT bilið á hjartalínuriti í tveimur rannsóknum sem gerðar voru hjá heilbrigðum sjálfboðaliðum.
English: Population PK analyses of pasireotide intramuscular use suggest that race does not influence PK parameters.
Icelandic: Lyfjahvarfagreining fyrir pasireotid til notkunar í vöðva hjá mismunandi hópum bendir til þess að kynþáttur hafi ekki áhrif á lyfjahvarfagildi.
English: Missed dose
Icelandic: - Minni matarlyst
English: The efficacy and safety of pasireotide intramuscular use was evaluated in a phase III, multicentre study over a 12-month treatment period in Cushing's disease patients with persistent or recurrent disease or de novo patients for whom surgery was not indicated or who refused surgery.
Icelandic: stigs fjölsetra rannsókn á 12 mánaða meðferðartíma hjá sjúklingum með Cushings sjúkdóm með þrálátan eða endurkominn sjúkdóm eða de novo sjúklingum þar sem skurðaðgerð átti ekki við eða sem neituðu skurðaðgerð.
English: Signifor 30 mg: each vial contains 30 mg pasireotide (as pasireotide pamoate).
Icelandic: Signifor 30 mg: hvert hettuglas inniheldur 30 mg af pasireotidi (sem pasireotid pamoat).
English: Signifor 60 mg: each vial contains 60 mg pasireotide (as pasireotide pamoate).
Icelandic: Signifor 60 mg: hvert hettuglas inniheldur 60 mg af pasireotidi (sem pasireotid pamoat).
English: Talk to your doctor before using Signifor if you currently have or have ever had: - problems with your blood sugar levels, whether too high (as in diabetes) or too low
Icelandic: Leitið ráða hjá lækninum áður en Signifor er notað ef þú ert með eða hefur verið með: - sjúkdóma í tengslum við blóðsykur, hvort sem hann er of hár (eins og í sykursýki) eða of lágur; - hjartasjúkdóma svo sem nýlegt hjartaáfall, hjartabilun (hjartasjúkdóm sem veldur því að hjartað getur ekki dælt nægilega miklu blóði um líkamann) eða skyndilegan þrýstingsverk fyrir brjósti
English: Asymptomatic elevations in lipase and amylase were observed in patients receiving pasireotide in clinical studies.
Icelandic: Einkennalausar hækkanir á lípasa og amýlasa komu fram hjá sjúklingum á meðferð með pasireotidi í klínískum rannsóknum.
English: QTcF >480 ms was reported for 3 versus 2 patients in the pasireotide intramuscular use and octreotide intramuscular use groups, respectively, and QTcF >60 ms prolonged from baseline was reported for 2 versus 1 patients in the respective groups.
Icelandic: hjá 3 sjúklingum sem fengu pasireotid í vöðva samanborið við 2 sjúklinga hjá þeim sem fengu octreotid í vöðva og greint var frá QTcF >60 msek.
English: A sharps container or other rigid closed disposal container
Icelandic: Ílát fyrir beitta hluti eða annað hart lokað ílát til förgunar
English: Signifor 10 mg: each vial contains 10 mg pasireotide (as pasireotide pamoate).
Icelandic: Signifor 10 mg: hvert hettuglas inniheldur 10 mg af pasireotidi (sem pasireotid pamoat).
English: Paediatric population No studies have been performed in paediatric patients.
Icelandic: Börn Engar rannsóknir hafa verið gerðar hjá börnum.
English: One vial contains 20 mg pasireotide (as pasireotide pamoate).
Icelandic: 1 hettuglas inniheldur 20 mg af pasireotidi (sem pasireotid pamoat).
English: Signifor 40 mg powder and solvent for suspension for injection EU/1/12/753/014-015
Icelandic: Signifor 40 mg stungulyfsstofn og leysir, dreifa EU/1/12/753/014-015
English: Extension phase
Icelandic: Framlengingarstig
English: Ampoules should be opened just prior to administration, and any unused portion discarded.
Icelandic: Opna á lykjurnar rétt fyrir notkun og farga allri ónotaðri lausn.
English: Sites showing signs of inflammation or irritation should be avoided.
Icelandic: Forðast skal stungustaði sem bera merki um bólgu eða ertingu.
English: Check with your doctor or pharmacist if you are not sure.
Icelandic: - Leitið til læknisins, hjúkrunarfræðingsins eða lyfjafræðings ef þörf er á frekari upplýsingum.
English: Signifor 60 mg powder and solvent for suspension for injection One vial contains 60 mg pasireotide (as pasireotide pamoate).
Icelandic: Signifor 60 mg stungulyfsstofn og leysir, dreifa Eitt hettuglas inniheldur 60 mg af pasireotidi (sem pasireotid pamoat).
English: Vascular disorders
Icelandic: Efnaskipti sykurs
English: Signifor 40 mg: each vial contains 40 mg pasireotide (as pasireotide pamoate).
Icelandic: Signifor 40 mg: hvert hettuglas inniheldur 40 mg af pasireotidi (sem pasireotid pamoat).
English: One vial contains 60 mg pasireotide (as pasireotide pamoate).
Icelandic: 1 hettuglas inniheldur 60 mg af pasireotidi (sem pasireotid pamoat).
English: There are no clinical data available on switching from the intramuscular to the subcutaneous pasireotide formulation.
Icelandic: Engar klínískar upplýsingar liggja fyrir um skipti úr lyfjaformi pasireotids til notkunar í vöðva yfir í lyfjaform til notkunar undir húð.
English: Signifor 30 mg powder and solvent for suspension for injection One vial contains 30 mg pasireotide (as pasireotide pamoate).
Icelandic: Signifor 30 mg stungulyfsstofn og leysir, dreifa Eitt hettuglas inniheldur 30 mg af pasireotidi (sem pasireotid pamoat).
English: The safety profile of Signifor was consistent with the somatostatin analogue class, except for the occurrence of hypocortisolism and degree of hyperglycaemia.
Icelandic: Öryggi Signifor var í samræmi við önnur lyf af flokki somatostatin hliðstæða, nema hvað varðar kortisólskort í blóði og hversu mikil blóðsykurshækkunin er.
English: 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).
Icelandic: stigs rannsókninni G2304 (miðgildi útsetningartíma: 57 vikur).
English: Remove the Signifor injection kit from refrigerated storage.
Icelandic: Signifor inndælingarbúnaðinn úr kælinum.
English: Tartaric acid Sodium hydroxide Water for injections
Icelandic: Tartarsýra (vínsýra) Natríumhýdroxíð
English: Management of suspected adverse reactions or over-response to treatment (cortisol levels < lower limit of normal) may require dose reduction, interruption or discontinuation of Signifor.
Icelandic: Þurft getur að minnka skammt, gera hlé á meðferð eða hætta meðferð með Signifor vegna gruns um aukaverkanir eða ofsvörunar við meðferð (kortisólgildi < eðlileg neðri mörk).
English: (figure B).
Icelandic: n (%)
English: Signifor 40 mg powder and solvent for suspension for injection One vial contains 40 mg pasireotide (as pasireotide pamoate).
Icelandic: Signifor 40 mg stungulyfsstofn og leysir, dreifa Eitt hettuglas inniheldur 40 mg af pasireotidi (sem pasireotid pamoat).
English: - Inflammation of the gallbladder (cholecystitis).
Icelandic: Kortisólskortur í blóði (hypocortisolism)
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.
Icelandic: Það er notað til meðferðar við Cushings sjúkdómi hjá fullorðnum þegar skurðaðgerð er ekki möguleg eða þegar skurðaðgerð hefur ekki borið árangur.
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.
Icelandic: Signifor 60 mg er fáanlegt í stakpakkningum sem innihalda eitt hettuglas með stungulyfsstofni með 60 mg af pasireotidi og eina áfyllta sprautu með 2 ml af leysi.
English: Dose reduction by decrements of 0.3 mg twice a day is suggested.
Icelandic: Lagt er til að skammtar séu minnkaðir, í skrefum, um 0,3 mg tvisvar á sólarhring.
English: One vial contains 30 mg pasireotide (as pasireotide pamoate).
Icelandic: 1 hettuglas inniheldur 30 mg af pasireotidi (sem pasireotid pamoat).
English: Cholecystitis *, cholestasis
Icelandic: Höfuðverkur, sundl
English: Grade 3 and 4 adverse reactions were mostly related to hyperglycaemia.
Icelandic: Flestar 3. og 4. stigs aukaverkanir tengdust of lágum blóðþrýstingi.
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.
Icelandic: Signifor 40 mg er fáanlegt í stakpakkningum sem innihalda eitt hettuglas með stungulyfsstofni með 40 mg af pasireotidi og eina áfyllta sprautu með 2 ml af leysi.
English: Signifor 10 mg powder and solvent for suspension for injection One vial contains 10 mg pasireotide (as pasireotide pamoate).
Icelandic: Signifor 10 mg stungulyfsstofn og leysir, dreifa Eitt hettuglas inniheldur 10 mg af pasireotidi (sem pasireotid pamoat).
English: Signifor 10 mg powder and solvent for suspension for injection EU/1/12/753/018
Icelandic: Signifor 10 mg stungulyfsstofn og leysir, dreifa EU/1/12/753/018
English: Your doctor will regularly monitor your condition to check that the treatment is having the desired effect.
Icelandic: Þetta er langtímameðferð, sem stendur hugsanlega yfir í nokkur ár. Læknirinn mun hafa reglulegt eftirlit með sjúkdómnum til að ganga úr skugga um að meðferðin hafi tilætluð áhrif.
English: 1 pre-filled syringe with 2 ml solvent 1 safety-engineered needle 1 vial adapter
Icelandic: 1 hettuglas með stungulyfsstofni 1 áfyllt sprauta með 2 ml af leysi 1 nál með öryggisbúnaði 1 millistykki fyrir hettuglös
English: Switch from subcutaneous to intramuscular formulation in Cushing's disease There are no clinical data available on switching from the subcutaneous to the intramuscular pasireotide formulation.
Icelandic: Skipt úr lyfjaformi til notkunar undir húð yfir í lyfjaform til notkunar í vöðva við Cushings sjúkdóm
English: One vial contains 10 mg pasireotide (as pasireotide pamoate).
Icelandic: 1 hettuglas inniheldur 10 mg af pasireotidi (sem pasireotid pamoat).
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.
Icelandic: Signifor 30 mg er fáanlegt í stakpakkningum sem innihalda eitt hettuglas með stungulyfsstofni með 30 mg af pasireotidi og eina áfyllta sprautu með 2 ml af leysi.
English: One case of ketosis and one case of ketoacidosis have been reported during compassionate use of Signifor.
Icelandic: Greint hefur verið frá einu tilviki ketónkvilla (ketosis) og einu tilviki ketónblóðsýringar (ketoacidosis)
English: One vial contains 40 mg pasireotide (as pasireotide pamoate).
Icelandic: 1 hettuglas inniheldur 40 mg af pasireotidi (sem pasireotid pamoat).
English: Signifor 20 mg powder and solvent for suspension for injection EU/1/12/753/013
Icelandic: Signifor 20 mg stungulyfsstofn og leysir, dreifa EU/1/12/753/013
English: In both dose groups, Signifor resulted in a decrease in mean UFC after 1 month of treatment, and this was maintained over time.
Icelandic: Signifor til lækkunar á meðaltali UFC eftir 1 meðferðarmánuð og það hélst á rannsóknartímanum.
English: Uncommon (may affect up to 1 in 100 people) - Low level of red blood cells (anaemia)
Icelandic: Algengar (geta komið fyrir hjá allt að 1 af hverjum 10 einstaklingum) - Þreyta, máttstol, fölvi (einkenni lítils magns af rauðum blóðkornum)
English: Signifor 0.9 mg injection pasireotide
Icelandic: Signifor 0,9 mg stungulyf, lausn pasireotid
English: Hyperglycaemia and, less frequently, hypoglycaemia, were observed in subjects participating in clinical studies with pasireotide (see section 4.8).
Icelandic: Of hár blóðsykur og sjaldnar of lágur blóðsykur komu fram hjá einstaklingum sem tóku þátt í klínískum rannsóknum á pasireotidi (sjá kafla 4.8).
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.
Icelandic: Signifor 10 mg er fáanlegt í stakpakkningum sem innihalda eitt hettuglas með stungulyfsstofni með 10 mg af pasireotidi og eina áfyllta sprautu með 2 ml af leysi.
English: What you need to know before you use Signifor
Icelandic: Áður en byrjað er að nota Signifor
English: Signifor solution for injection should be free of visible particles, clear and colourless.
Icelandic: Signifor stungulyf, lausn á að vera án sýnilegra agna, tær og litlaus.
English: • metformin, liraglutide, vildagliptin, nateglinide (antidiabetic medicines); - medicines to treat irregular heartbeat, such as medicines containing disopyramide,
Icelandic: • metformin, liraglutid, vildagliptin, nateglinid (sykursýkilyf); - lyf við hjartsláttaróreglu, svo sem lyf sem innihalda disopyramíð, procainamíð, kínidín, sotalol,
English: Signifor is to be administered subcutaneously by self injection.
Icelandic: Signifor er ætlað til inndælingar undir húð af sjúklingnum sjálfum.
English: Pasireotide has been shown to prolong the QT interval on the ECG in two dedicated healthy volunteer studies performed with the subcutaneous formulation.
Icelandic: Komið hefur í ljós að pasireotid lengdi QT bilið á hjartalínuriti í tveimur rannsóknum sem gerðar voru hjá heilbrigðum sjálfboðaliðum með lyfjaformi til notkunar undir húð.
English: If not used within 24 hours, the injection kit can be returned to the fridge.
Icelandic: Ef hann er ekki notaður innan 24 klst.
English: At month 12, reduction in tumour volume was comparable between the treatment groups and in patients with and without previous pituitary surgery.
Icelandic: Eftir 12 mánuði var minnkun á rúmmáli æxlis sambærileg milli meðferðarhópanna og hvort sem sjúklingarnir höfðu gengist undir skurðaðgerð á heiladingli eða ekki.
English: Signifor 20 mg powder and solvent for suspension for injection pasireotide
Icelandic: Signifor 20 mg stungulyfsstofn og leysir, dreifa pasireotid
English: Signifor 0.6 mg injection pasireotide
Icelandic: Signifor 0,6 mg stungulyf, lausn pasireotid
English: 1 ml solution for injection contains 0.6 mg pasireotide (as pasireotide diaspartate).
Icelandic: 1 ml af stungulyfi, lausn inniheldur 0,6 mg af pasireotidi (sem pasireotid diaspartat).
English: INSTRUCTIONS FOR USE OF SIGNIFOR SOLUTION FOR INJECTION
Icelandic: Upplýsingar fyrir notanda lyfsins
English: 1 ml solution for injection contains 0.9 mg pasireotide (as pasireotide diaspartate).
Icelandic: 1 ml af stungulyfi, lausn inniheldur 0,9 mg af pasireotidi (sem pasireotid diaspartat).
English: Table 4 Key results at month 12 - phase III study in acromegaly patients
Icelandic: Tafla 4 Lykilniðurstöður eftir 12 mánuði - III.
English: CARTON OF UNIT PACK
Icelandic: INNRI UMBÚÐUM LÍTILLA EININGA
English: Signifor 0.3 mg injection pasireotide
Icelandic: Signifor 0,3 mg stungulyf, lausn pasireotid
English: Anaemia
Icelandic: ASKJA
English: Common (may affect up to 1 in 10 people) - Low cortisol levels.
Icelandic: Algengar (geta komið fyrir hjá allt að 1 af hverjum 10 einstaklingum)
English: The European Medicines Agency has waived the obligation to submit the results of studies with Signifor in all subsets of the paediatric population in pituitary-dependant Cushing's disease, overproduction of pituitary ACTH and pituitary dependant hyperadrenocorticism (see section 4.2 for information on paediatric use).
Icelandic: á Signifor hjá öllum undirhópum barna við Cushings sjúkdómi sem tengist heiladingli, offramleiðslu á ACTH í heiladingli og ofvirkni í nýrnahettum sem er háð heiladingulsstarfsemi (sjá upplýsingar í kafla 4.2 um notkun handa börnum).
English: Abdominal pain includes abdominal pain and abdominal pain upper.
Icelandic: Hægur sínustaktur felur í sér hægan hjartslátt og hægan sínustakt.
English: Diarrhoea, abdominal pain, nausea
Icelandic: Niðurgangur, kviðverkir, ógleði
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).
Icelandic: Fyrirliggjandi upplýsingar hafa sýnt að pasireotid skilst út í móðurmjólk hjá rottum þegar pasireotid er gefið undir húð (sjá kafla 5.3).
English: Signifor 30 mg powder and solvent for suspension for injection EU/1/12/753/019
Icelandic: Signifor 30 mg stungulyfsstofn og leysir, dreifa EU/1/12/753/019
English: 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.
Icelandic: QT lengingar milli pasireotids til notkunar í vöðva og somatostatin hliðstæðanna sem voru rannsakaðar sem virkt samanburðarlyf í klínísku III. stigs rannsóknunum hjá sjúklingum með æsavöxt.
English: Intramuscular use.
Icelandic: - Virka innihaldsefnið er pasireotid.
English: min
Icelandic: mín.