FrancophonIA/ELRC3.0 huggingface dataset:
English: Pharmacodynamic effects
Icelandic: Krabbameinsvaldandi áhrif
English: Bosulif 500 mg film-coated tablets bosutinib
Icelandic: Bosulif 500 mg filmuhúðaðar töflur bosutinib
English: Bosulif 500 mg film-coated tablets
Icelandic: Bosulif 500 mg filmuhúðaðar töflur
English: Bosulif 100 mg film-coated tablets bosutinib
Icelandic: Bosulif 100 mg filmuhúðaðar töflur bosutinib
English: NAME OF THE MARKETING AUTHORISATION HOLDER
Icelandic: ÚTGÁFU SKILYRTS MARKAÐSLEYFIS
English: Bosulif 100 mg film-coated tablets
Icelandic: Bosulif 100 mg filmuhúðaðar töflur
English: Tell your doctor if you develop abdominal pain or discomfort.
Icelandic: Láttu lækninn vita ef þú færð verk eða óþægindi í kvið.
English: Pretreated and advanced stage CML patients on 500 mg showed a median eGFR decline of 5.3 ml/min/1.73 m2 at 3 months, of 7.6 ml/min/1.73 m2 at 12 months and of up to 10.9 ml/min/1.73 m2 in up to 4 years on treatment.
Icelandic: Hjá sjúklingum með formeðhöndlað, langt gengið langvinnt kyrningahvítblæði sem fengu 500 mg var miðgildi eGFR lækkunar upp á 5,3 ml/mín./1,73 m eftir 3 mánuði, 7,6 ml/mín./1,73 m 2 eftir 12 mánuði og allt að
English: Hepatitis B reactivation
Icelandic: Uppsöfnuð blóðfræðileg svörun d
English: Other efficacy endpoints include the cumulative MCyR rate, time to and duration of MCyR, and time to and duration of CHR, in patients with CP CML previously treated with only 1 prior TKI (imatinib).
Icelandic: Meðal annarra mælibreyta fyrir virkni voru uppsöfnuð tíðni meiri háttar litningasvörunar, tími fram að og lengd meiri háttar litningasvörunar og tími fram að og lengd algerrar blóðfræðilegrar svörunar, hjá sjúklingum með langvinnt kyrningahvítblæði í langvinnum fasa, sem áður höfðu aðeins fengið meðferð með einum týrosín kínasa hemli (imatinibi).
English: A no observed effect level (NOEL) for pupil size was not established, but the NOEL for impaired gait occurred at exposures approximately 11-times the human exposure resulting from the clinical dose of 400 mg and 8-times the human exposure resulting from the clinical dose of 500 mg (based on unbound Cmax in the respective species).
Icelandic: 11 sinnum útsetningu hjá mönnum eftir klínískan skammt með 400 mg og 8 sinnum útsetningu hjá mönnum eftir klínískan skammt með 500 mg (byggt á óbundnu hlutfalli Cmax hjá viðkomandi tegundum).
English: Bosutinib displays pH-dependent aqueous solubility in vitro.
Icelandic: Leysanleiki bosutinibs í vatnslausn in vitro er háður sýrustigi.
English: If you get any side effects, talk to your doctor or pharmacist or nurse.
Icelandic: Látið lækninn eða lyfjafræðing eða hjúkrunarfræðinginn vita um allar aukaverkanir.
English: Carcinogenicity Bosutinib was not carcinogenic in the 2-year rat carcinogenicity study.
Icelandic: Í 2 ára rannsókn á krabbameinsvaldandi áhrifum hjá rottum reyndist bosutinib ekki hafa krabbameinsvaldandi áhrif.
English: Repeated-dose toxicity
Icelandic: Eiturverkanir endurtekinna skammta
English: Erythema multiforme
Icelandic: Langvinnur fasi
English: Recent or ongoing clinically significant gastrointestinal disorder In clinical studies, patients with recent or ongoing clinically significant gastrointestinal disorder (e.g., severe vomiting and/or diarrhoea) were excluded.
Icelandic: Sjúklingar með nýlega eða virka klínískt marktæka meltingarfærakvilla (t.d. alvarleg uppköst og/eða niðurgang) voru útilokaðir frá þátttöku í klínískum rannsóknum.
English: No evidence of leukaemia (NEL): Meets all other criteria for CHR except may have thrombocytopenia (platelets greater than or equal to 20,000/mm and less than 100,000/mm 3) and/or neutropenia (ANC greater than or equal to 0.5×10
Icelandic: 100.000/mm 3) og/eða daufkyrningafæð (heildar daufkyrningafjöldi meiri en eða jafn 0,5 x 10
English: Dose reductions are recommended for severe or persistent neutropenia and thrombocytopenia as described in Table 1:
Icelandic: Ef fram kemur alvarleg eða viðvarandi daufkyrningafæð eða blóðflagnafæð er ráðlagt að minnka skammta eins og lýst er í töflu 1:
English: CP, AP, or BP Ph+ CML with resistance or intolerance to prior therapy In patients with moderate renal impairment (CLCr 30 to 50 mL/min, calculated by the Cockcroft-Gault formula), the recommended dose of bosutinib is 400 mg daily (see sections 4.4 and 5.2).
Icelandic: Nýgreint Ph+ langvinnt kyrningahvítblæði í langvinnum fasa Hjá sjúklingum með miðlungi skerta nýrnastarfsemi (kreatínín úthreinsum [CLCr] 30 til 50 ml/mín., reiknað með Cockcroft-Gault reiknireglunni), er ráðlagður skammtur af bosutinibi 300 mg á sólarhring með mat (sjá kafla 4.4 og 5.2).
English: ANNEX I
Icelandic: Heildarlifun f
English: The liver was also identified as a target organ in rats.
Icelandic: Hjá rottum reyndist lifrin einnig verða fyrir eituráhrifum.
English: BLISTER
Icelandic: Lyfhrif
English: A decline over time in estimated glomerular filtration rate (eGFR) has been observed in patients treated with bosutinib in clinical studies.
Icelandic: Hjá sjúklingum sem fengu meðferð með bosutinibi í klínískum rannsóknum sást minnkun á áætluðum gaukulsíunarhraða (eGFR) með tímanum.
English: In an intravenous study in dogs, transient increases in heart rate and decreases in blood pressure and minimal prolongation of the QTc (< 10 msec) were observed at exposures ranging from approximately 6-times to 20-times the human exposure resulting from the clinical dose of 400 mg and 4-times to 15-times the human exposure resulting from the clinical dose of 500 mg (based on unbound Cmax in the respective species).
Icelandic: 6 sinnum til 20 sinnum útsetningu hjá mönnum eftir klínískan skammt með 400 mg og 4 sinnum til 15 sinnum útsetning hjá mönnum eftir klínískan skammt með 500 mg (byggt á óbundnu hlutfalli Cmax hjá viðkomandi tegundum).
English: Anti-arrhythmic medicinal products and other substances that may prolong QT Bosutinib should be used with caution in patients who have or may develop prolongation of QT, including those patients taking anti-arrhythmic medicinal products such as amiodarone, disopyramide, procainamide, quinidine and sotalol or other medicinal products that may lead to QT prolongation such as chloroquine, halofantrine, clarithromycin, domperidone, haloperidol, methadone, and moxifloxacin (see section 4.4).
Icelandic: QT, svo sem klórókín, halófantrín, klaritrómycín, domperidón, halóperidól, metadon og moxifloxacín (sjá kafla 4.4).
English: - haloperidol, used to treat psychotic disease such as schizophrenia.
Icelandic: - halóperidól, notað við geðrofskvillum, svo sem geðklofa.
English: Liver function abnormalities
Icelandic: Skert lifrarstarfsemi
English: Patients with diarrhoea and vomiting should be managed using standard-of-care treatment, including an antidiarrhoeal or antiemetic medicinal product and/or fluid replacement.
Icelandic: Bregðast á við niðurgangi og uppköstum hjá sjúklingum með venjubundnum úrræðum, þ.m.t. hægðastemmandi lyfjum eða uppsöluhemjandi lyfjum og/eða vökvagjöf.
English: C] radiolabelled bosutinib to lactating
Icelandic: Rannsókn a bosutinib
English: The dose at which no adverse development effects were observed (10 mg/kg/day) resulted in exposures equal to 1.3-times and 1.0-times human exposure resulting from the clinical dose of 400 mg and 500 mg, respectively (based on unbound AUC in the respective species).
Icelandic: Stærsti skammtur sem hafði ekki áhrif (10 mg/kg/dag) leiddi til útsetningar sem jafngilti 1,3-faldri útsetningu hjá mönnum sem fengu klíníska skammta sem námu 400 mg og 1,0-faldri útsetningu hjá mönnum sem fengu klíníska skammta sem námu
English: Genotoxicity
Icelandic: Taugakerfi
English: - nasopharyngitis.
Icelandic: - Nefkoksbólga.
English: Fluid retention
Icelandic: Endurvirkjun lifrarbólgu
English: Safety pharmacology
Icelandic: LYFJAFRÆÐILEGAR
English: The cumulative incidence of MMR adjusting for competing risk of treatment discontinuation without MMR was higher in the bosutinib treatment group compared to the imatinib treatment group in the mITT population (45.1% [95% CI: 38.8%, 51.2%] versus 33.7% [95% CI: 27.8%, 39.6%] at Week 48; hazard ratio [HR] from a stratified proportional subdistributional hazards model: 1.35 [95% CI: 1.07, 1.70], 1-sided p-value = 0.0086).
Icelandic: 48; áhættuhlutfall [HR] úr lagskiptu hlutfallslegu áhættulíkani undir dreifingarmörkum: 1,35 [95% CI: 1,07; 1,70], einhliða p-gildi = 0,0086).
English: - boceprevir and telaprevir, used to treat hepatitis C. - aprepitant, used to prevent and control nausea (feeling sick) and vomiting.
Icelandic: fosamprenavír og darunavír, notuð við sýkingum af völdum alnæmisveiru (HIV)/AIDS. - boceprevír og telaprevír, notuð við lifrarbólgu C. - aprepitant, notað til að koma í veg fyrir og tempra ógleði og uppköst. - imatiníb, notað við tiltekinni tegund hvítblæðis.
English: - joint pain, back pain.
Icelandic: - Liðverkir, bakverkur.
English: Acute kidney injury, Renal failure, Renal impairment General disorders and administration site conditions Very common Pyrexia, Asthenia, Oedema (including Face oedema, Localised oedema, Oedema peripheral), Fatigue (including Malaise)
Icelandic: Bráð nýrnaskemmd, nýrnabilun, skert nýrnastarfsemi Almennar aukaverkanir og aukaverkanir á íkomustað Mjög algengar Hiti, þróttleysi, bjúgur (m.a. andlitsbjúgur, staðbundinn bjúgur, útlimabjúgur), þreyta (m.a. lasleiki)
English: In patients with severe renal impairment (CLCr < 30 mL/min, estimated by the Cockcroft-Gault formula), the recommended dose of bosutinib is 200 mg daily with food (see sections 4.4 and 5.2).
Icelandic: Hjá sjúklingum með alvarlega skerta nýrnastarfsemi (CLCr < 30 ml/mín., reiknað með Cockcroft-Gault reiknireglunni), er ráðlagður skammtur af bosutinibi 200 mg á sólarhring með mat (sjá kafla 4.4 og
English: Abbreviations: BCR-ABL=breakpoint cluster region-Abelson; CI=confidence interval;
Icelandic: BCR-ABL=BCR-ABL krabbameinsgen, CI=öryggisbil, CMH=Cochran-Mantel-Haenszel,
English: - efavirenz and etravirine, used to treat HIV infections/AIDS.
Icelandic: - efavírenz og etravirín, notuð við HIV sýkingum/AIDS. - modafiníl, notað við tilteknum svefnröskunum.
English: Belgium
Icelandic: България
English: What Bosulif looks like and contents of the pack Bosulif 100 mg film-coated tablets are yellow, oval biconvex, debossed with “Pfizer” on one side and “100” on the other side.
Icelandic: Bosulif 100 mg filmuhúðaðar töflur eru gular, sporöskjulaga, tvíkúptar, með ígreyptu „Pfizer“ öðru megin og „100“ hinum megin.
English: In patients with moderate renal impairment (creatinine clearance [CLCr] 30 to 50 mL/min, estimated by the Cockcroft-Gault formula), the recommended dose of bosutinib is 300 mg daily with food (see sections 4.4 and 5.2).
Icelandic: Ráðlagður skammtur fyrir sjúklinga með miðlungi skerta nýrnastarfsemi (CLCr 30 til 50 ml/mín., reiknað með Cockcroft-Gault reiknireglunni) er 400 mg af bosutinibi á dag (sjá kafla 4.4 og 5.2).
English: Rare side effects (may affect up to 1 in 1,000 people): - severe skin disorder (erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis) due to an allergic reaction, exfoliative (scaly, peeling) rash.
Icelandic: - Alvarlegur húðkvilli (regnbogaroðasótt, Stevens-Johnson heilkenni, eitrunardreplos húðþekju)
English: The evaluable population includes patients who had a valid baseline disease assessment.
Icelandic: Sjúklinga sem unnt var að meta eru sjúklingar með nothæft mat á sjúkdómi við upphaf rannsóknar.
English: Biotransformation
Icelandic: Lyfjafræðilegt
English: Hypertension (including Blood pressure increased, Blood pressure systolic increased, Essential hypertension, Hypertensive crisis) Respiratory, thoracic and mediastinal disorders Very common Dyspnoea, Cough Common
Icelandic: frumkominn háþrýstingur, háþrýstingskreppa) Öndunarfæri, brjósthol og miðmæti Mjög algengar Mæði, hósti
English: Clinical study in imatinib-resistant or intolerant CML in CP, AP, and BP A single-arm, Phase 1/2 open-label, multicentre trial was conducted to evaluate the efficacy and safety of bosutinib 500 mg once daily in patients with imatinib-resistant or -intolerant CML with separate cohorts for chronic, accelerated, and blast phase disease previously treated with 1 prior TKI (imatinib) or more than 1 TKI (imatinib followed by dasatinib and/or nilotinib).
Icelandic: Klínísk rannsókn á langvinnu kyrninguhvítblæði í langvinnum fasa, hröðunarfasa eða bráðafasa sem var ónæmt fyrir imatinibi eða þar sem imatinib þoldist ekki Gerð var 1./2. stigs opin, fjölsetra rannsókn, þar sem allir fengu sömu meðferð, til að meta virkni og öryggi bosutinib
English: Blood and lymphatic system disorders
Icelandic: Lifrarskemmd (m.a. lifrarskemmd af völdum lyfja)
English: Very common side effects (may affect more than 1 in 10 people): - reduction in the number of platelets, red blood cells and/or neutrophils (type of white blood cells).
Icelandic: - Fækkun blóðflagna, rauðra blóðkorna og/eða daufkyrninga (tegund hvítra blóðkorna).
English: Pleural effusion Uncommon Pulmonary hypertension, Respiratory failure, Acute pulmonary oedema Gastrointestinal disorders Very common Diarrhoea, Vomiting, Nausea, Abdominal pain (including Abdominal discomfort, Abdominal pain lower, Abdominal pain upper, Abdominal tenderness, Gastrointestinal pain)
Icelandic: Mjög algengar Niðurgangur, uppköst, ógleði, kviðverkir (m.a. óþægindi í kvið, verkur í neðra kviðarholi, verkur í efra kviðarholi, eymsli í kvið, verkur í meltingarvegi)
English: Automated machine-read QTc prolongation without accompanying arrhythmia has been observed.
Icelandic: QTc án samhliða hjartsláttartruflana í sjálfvirkum, vélrænum úrlestri.
English: K-M at year 1/2, % (95% CI)c K-M at year 4/5, % (95% CI)c Median, weeks (95% CI)
Icelandic: K-M eftir 4/5 ár, % (95% CI)
English: Bosutinib minimally inhibits platelet-derived growth factor (PDGF) receptor and c-Kit.
Icelandic: Bosutinib hefur lítil sem engin hamlandi áhrif á blóðflöguafleiddan vaxtarþátt (PDGF)
English: Some cases resulted in acute hepatic failure or fulminant hepatitis leading to liver transplantation or a fatal outcome (see section 4.4).
Icelandic: Í tengslum við BCR-ABL týrosínkínasahemla hefur verið greint frá endurvirkjun lifrarbólgu B. Sum tilvik enduðu í bráðri lifrarbilun eða svæsinni lifrarbólgu sem leiddi til lifrarígræðslu eða dauða (sjá kafla 4.4).
English: Date of first authorisation: 27 March 2013 Date of latest renewal: 18 February 2019
Icelandic: 18. febrúar 2019
English: Stevens-Johnson Syndrome**, Toxic epidermal necrolysis** Musculoskeletal and connective tissue disorders Very common Arthralgia, Back pain Common
Icelandic: Húðflagningsútbrot, lyfjaútbrot Mjög sjaldgæfar Regnbogaroðasótt Tíðni ekki þekkt Stevens-Johnson heilkenni
English: Clinical study in CP previously untreated CML
Icelandic: Klínísk rannsókn á áður ómeðhöndluðu langvinnu kyrningahvítblæði í langvinnum fasa
English: For patients previously treated with both imatinib and at least 1 additional TKI, the endpoints include the cumulative MCyR rate, time to and duration of MCyR, and time to and duration of CHR. For patients with AP and BP CML previously treated with at least 1 prior TKI (imatinib), the endpoints were cumulative overall haematological response (OHR) and time to and duration of OHR.
Icelandic: Meðal mælibreyta fyrir sjúklinga sem áður höfðu fengið meðferð með imatinibi og a.m.k. einum öðrum týrosín kínasa hemli voru uppsöfnuð tíðni meiri háttar litningasvörunar, tími fram að og lengd meiri háttar litningasvörunar og tími fram að og lengd algerrar blóðfræðilegrar svörunar.
English: Бъ лгария
Icelandic: • nýgreint
English: Liver disorders.
Icelandic: Lifrarkvillar.
English: Pregnancy
Icelandic: Mergbæling
English: Table 6 - Response by baseline BCR-ABL mutation status in CP CML evaluable population: prior imatinib and dasatinib and/or nilotinib (third-line)
Icelandic: fyrri meðferð með imatinibi og dasatinibi og/eða nilotinibi (þriðja meðferð)
English: LABELLING AND PACKAGE LEAFLET
Icelandic: Húð og undirhúð
English: Annex related to the Art. 127a
Icelandic: Viðauki sbr. grein 127a
English: The Member State shall ensure that the MAH shall implement a pregnancy prevention programme (PPP) within their territory.
Icelandic: Aðildarríkið skal tryggja að MLH komi á getnaðarvarnaráætlun (pregnancy prevention programme (PPP)) innan yfirráðasvæðis aðildarríkisins.
English: - Prior to prescribing (where appropriate, and in agreement with the National Competent Authority, dispensing) all healthcare professionals who intend to prescribe (and dispense) pomalidomide are provided with a physician information pack containing the following: - Educational Health Care Professional's kit - Educational brochures for Patients - Patient cards - Summary of Product Characteristics (SmPC) and Package Leaflet and Labelling.
Icelandic: - Áður en lyfinu er ávísað (og þar sem við á, og samkvæmt samkomulagi við viðeigandi yfirvöld, fyrir afhendingu) fær allt heilbrigðisstarfsfólk sem áætlað er að muni ávísa (og afhenda) pómalídómíð, pakka með upplýsingum fyrir lækna sem inniheldur eftirfarandi gögn:
English: Details of the PPP including the set-up of national measures to assess the effectiveness of and compliance with the PPP should be agreed with the National Competent Authorities in each Member State and put in place prior to the marketing of the product.
Icelandic: Nákvæm útfærsla á getnaðarvarnaráætluninni, þar með talið fyrirkomulag ráðstafana í hverju landi til að meta árangur af og fylgni við getnaðarvarnaráætlunina, skal vera samþykkt af viðeigandi yfirvöldum í hverju aðildarríki og sett fram fyrir markaðssetningu lyfsins.
English: The Member States should ensure that all conditions or restrictions with regard to the safe and effective use of the medicinal product described below are implemented: The Member State shall agree the details of a controlled distribution system with the Marketing Authorisation Holder (MAH) and must implement such programme nationally to ensure that: - Prior to launch, all doctors who intend to prescribe pomalidomide and all pharmacists who may dispense pomalidomide receive a Direct Healthcare Professional Communication as described below.
Icelandic: - Áður en lyfið er sett á markað eiga allir læknar sem áætlað er að muni ávísa pómalídómíði og allir lyfjafræðingar, sem hugsanlega munu afhenda pómalídómíð, að fá sent bréf til heilbrigðisstarfsfólks eins og lýst er hér á eftir.
English: EU/1/18/1331/001 Luxturna
Icelandic: EU/1/18/1331/001
English: Solvent: 1.7 ml
Icelandic: 1,7 ml
English: 5 x 1012 vg/ml Concentrate and solvent for solution for injection
Icelandic: 5 x 1012 vg/ml
English: Concentrate: 0.5 ml;
Icelandic: Þykkni: 0,5 ml; Leysir:
English: Subretinal use
Icelandic: Luxturna
English: Concentrate: vial (COC);
Icelandic: Þykkni: hettuglas (COC);
English: Solvent: vial (COC)
Icelandic: Leysir: hettuglas (COC)
English: Within 2 years after Commission Decision
Icelandic: Innan 2 ára frá ákvörðun nefndarinnar
English: This leaflet was last revised in <{MM/YYYY}> <{month YYYY}>.
Icelandic: Þessi fylgiseðill var síðast uppfærður <{MM/ÁÁÁÁ}.> <{mánuður ÁÁÁÁ}>.
English: Date of first authorisation: 22 March 2016
Icelandic: 22 mars 2016
English: 1) Limits for NDMA and NDEA outlined below should be implemented for a transitional period of 2 years:
Icelandic: 1) Takmörk fyrir NDMA og NDEA listuð hér fyrir neðan ætti að innleiða yfir 2 ára aðlögunartímabil:
English: Mylan Hungary Kft. Mylan utca 1, Komárom - 2900 Hungary
Icelandic: Mylan utca 1, Komárom - 2900
English: Clarithromycin is an inhibitor of CYP3A4.
Icelandic: Clarithromycin er hemill af CYP3A4 gerðinni.
English: Absolute bioavailability has been calculated as between 64 % and 80 %.
Icelandic: Reiknað hefur verið út að heildaraðgengi sé 64% til 80%.
English: 117 Allée des parcs 69800 Saint Priest France
Icelandic: Allée des parcs 69800
English: PVC/PCTFE blisters.
Icelandic: PVC/PCTFE þynnur.
English: Hypromellose Titanium dioxide (E171) Macrogol 8000
Icelandic: Hýprómellósa Títantvíoxíð (E171) Macrogol 8000
English: Consult a doctor immediately if you experience any of the following very rare, severe side effects after taking this medicine:
Icelandic: Ráðfærðu þig tafarlaust við lækni ef þú finnur fyrir einhverjum þessara alvarlegu aukaverkana, sem koma örsjaldan fyrir, eftir að hafa tekið lyfið:
English: Age, gender, race or body mass index (≥30 kg/m 2, <30 kg/m 2) did not influence the response to amlodipine/valsartan.
Icelandic: Aldur, kyn, kynþáttur eða líkamsþyngdarstuðull (≥ 30 kg/m 2, < 30 kg/m 2) hafði ekki áhrif á svörun við amlodipini/valsartani.
English: In vitro studies with amlodipine have shown that approximately 97.5 % of circulating drug is bound to plasma proteins.
Icelandic: Í in vitro rannsóknum á amlodipini hefur verið sýnt fram á að um það bil 97,5% af lyfinu í blóðrásinni eru bundin plasmapróteinum.
English: Valsartan is highly bound to serum proteins (94-97 %), mainly serum albumin.
Icelandic: Valsartan er mikið bundið sermispróteinum (94-97%), einkum albumini í sermi.
English: (It is also better to avoid Amlodipine/Valsartan Mylan in early pregnancy, see Pregnancy section).
Icelandic: (Einnig er betra að forðast að nota Amlodipine/Valsartan Mylan snemma á meðgöngu, sjá kaflann „Meðganga“).
English: Amlodipine/Valsartan Mylan is not recommended in early pregnancy (first 3 months), and must not be taken when more than 3 months pregnant, as it may cause serious harm to your baby if used after the third month of pregnancy.
Icelandic: Ekki er ráðlagt að nota Amlodipine/Valsartan Mylan snemma á meðgöngu (fyrstu 3 mánuðina), og ekki má nota það eftir þriðja mánuð meðgöngu því það getur haft alvarlegar afleiðingar fyrir barnið ef það er notað eftir þriðja mánuð meðgöngu.
English: The proportion of the maternal dose received by the infant has been estimated with an interquartile range of 3 - 7%, with a maximum of 15%.
Icelandic: Hlutfallið af skammti móður sem barnið fær með brjóstamjólk hefur verið áætlað að liggi á millifjórðungsbilinu 3 - 7%, að hámarki 15%.
English: Swelling of eyelids, face or lips.
Icelandic: - Bólga í augnlokum, andliti eða vörum.
English: Ten per cent of original amlodipine and 60 % of amlodipine metabolites are excreted in urine.
Icelandic: 10% af amlodipini sjálfu og 60% af umbrotsefnum amlodipins skiljast út í þvagi.
English: Your doctor will normally advise you to stop taking Amlodipine/Valsartan Mylan before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Amlodipine/Valsartan Mylan.
Icelandic: Læknirinn mun yfirleitt ráðleggja þér að hætta að nota Amlodipine/Valsartan Mylan áður en þú verður þunguð eða um leið og þú veist að þú ert þunguð og mun ráðleggja þér að nota önnur lyf í staðinn fyrir Amlodipine/Valsartan Mylan.
English: Mean systemic AUC of valsartan is higher by 70 % in the elderly than in the young, therefore caution is required when increasing the dosage.
Icelandic: Meðaltalsgildi almenns (systemic) AUC fyrir valsartan er yfir 70% hærra hjá öldruðum en ungum og skal því gæta varúðar þegar skammtar eru stækkaðir.
English: Pack sizes: 28, 56 or 98 film-coated tablets.
Icelandic: 28, 56 eða 98 filmuhúðaðar töflur.
English: Since there is no effect on ACE and no potentiation of bradykinin or substance P, angiotensin II antagonists are unlikely to be associated with coughing.
Icelandic: Vegna þess að ekki er um að ræða nein áhrif á ACE og enga aukningu á verkun bradykinina og „substance P“ er ólíklegt að angiotensin II viðtakablokkar tengist hósta.
English: Depending on how you respond to the treatment, your doctor may suggest a higher or lower strength.
Icelandic: Það fer eftir því hvernig lyfið verkar á hvern og einn hvort læknirinn ákveður að auka eða minnka styrkleikann.
English: if you have a condition affecting the renal glands called “primary hyperaldosteronism”.
Icelandic: - ef þú ert með sjúkdóm sem hefur áhrif á nýrnahetturnar og nefnist „frumkomið aldosteronheilkenni“.
English: For bottle packs: After first opening use within 100 days.
Icelandic: Eftir opnun skal nota lyfið innan 100 daga.