FrancophonIA/ELRC3.0 huggingface dataset:
English: Lactose monohydrate Microcrystalline cellulose Croscarmellose sodium Silica colloidal anhydrous Hypromellose Magnesium stearate.
Icelandic: Vatnsfrí kísilkvoða Hýprómellósa Magnesiumsterat.
English: Potassium supplements and potassium-sp aring diuretics: based on experience with the use of other medicinal products that affect the reninangiotensin system, concomitant use of potassium-sparing diuretics, potassium supplements, salt substitutes containing potassium or other medicinal products that may increase serum potassium levels (e.g. heparin) may lead to increases in serum potassium and is, therefore, not recommended (see section 4.4).
Icelandic: Með hliðsjón af notkun annarra lyfja sem hafa áhrif á renín-angíótensín kerfið, getur samtímis notkun kalíumsparandi þvagræsilyfja, kalíumuppbótar, saltuppbótar sem inniheldur kalíum eða annarra lyfja sem auka kalíumgildi í sermi (t.d. heparin) valdið aukningu á kalíum í sermi og er því ekki ráðlögð (sjá kafla 4.4).
English: Diuretics and other antihypertensive agents: other antihypertensive agents may increase the hypotensive effects of irbesartan; however irbesartan has been safely administered with other antihypertensive agents, such as beta-blockers, long-acting calcium channel blockers, and thiazide diuretics.
Icelandic: Önnur blóðþrýstingslækkandi lyf geta aukið blóðþrýstingslækkandi áhrif irbesartans; þó hefur samtímis gjöf irbesartans og annarra blóðþrýstingslækkandi lyfja eins og beta-blokka, langverkandi kalsíumgangaloka og tíazíð þvagræsilyfja reynst örugg.
English: Sabervel at a dose of 150 mg once daily generally provides a better 24 hour blood pressure control than 75 mg.
Icelandic: Með því að gefa 150 mg skammt af Sabervel einu sinni á sólarhring næst betri sólarhringsstjórn á blóðþrýstingi en með 75 mg skammti.
English: Sabervel 300 mg film-coated tablets irbesartan
Icelandic: Sabervel 300 mg filmuhúðaðar töflur irbesartan
English: Each tablet contains 150 mg irbesartan
Icelandic: Hver tafla inniheldur 150 mg irbesartan
English: • Patients with high blood pressure and type 2 diabetes with kidney disease In patients with high blood pressure and type 2 diabetes, 300 mg once daily is the preferred maintenance dose for the treatment of associated kidney disease.
Icelandic: Sjúklingar með háþrýsting og sykursýki tegund 2 með nýrnasjúkdómi Hjá sjúklingum með háþrýsting og sykursýki af gerð 2 eru 300 mg einu sinni á sólarhring ráðlagður viðhaldsskammtur við meðferð á tengdum nýrnasjúkdómi.
English: Irbesartan significantly reduced the relative risk in the primary combined endpoint of doubling serum creatinine, end-stage renal disease (ESRD) or all-cause mortality.
Icelandic: Irbesartan dró marktækt úr hlutfallslegri hættu á samsettum endapunkti sem var tvöföldun kreatiníns í sermi, nýrnasjúkdómi á lokastigi (ESRD, end stage renal disease) eða dauða af hvaða ástæðu sem er.
English: Paediatric population:
Icelandic: Aldraðir sjúklingar:
English: In patients not adequately controlled by irbesartan alone, the addition of a low dose of hydrochlorothiazide (12.5 mg) to irbesartan once daily results in a further placebo-adjusted blood pressure reduction at trough of 7-10/3-6 mm Hg (systolic/diastolic).
Icelandic: Hjá sjúklingum, þar sem ekki tekst að stjórna blóðþrýstingi á viðeigandi hátt með irbesartani eingöngu, verður, frekari blóðþrýstingslækkun um 7-10/3-6 mm Hg (slagbils/þanbils) ef litlum skammti af hýdróklórtíazíði (12,5 mg) er bætt við gjöf irbesartani einu sinni á sólarhring.
English: Sabervel 150 mg film-coated tablets irbesartan
Icelandic: Sabervel 150 mg filmuhúðaðar töflur irbesartan
English: M anufacture r:
Icelandic: ATC flokkur:
English: hypersensitivity reactions such as angioedema, rash, urticaria
Icelandic: Ofnæmisviðbrögð eins og ofsabjúgur, útbrot, ofsakláði
English: Pregnancy:
Icelandic: Töflukjarni:
English: Skin and subcutaneous tissue disorders: Not known:
Icelandic: Niðurgangur, meltingartruflanir/brjóstsviði Tíðni ekki þekkt:
English: What Sabervel looks like and contents of the pack Sabervel 75 mg film-coated tablets are white, concave, round, film-coated tablets with 7 mm diameter.
Icelandic: Sabervel 75 mg filmuhúðuð tafla er hvít, tvíkúpt, kringlótt, filmuhúðuð tafla með 7 mm í þvermál.
English: The study examined the long-term effects (2 years) of irbesartan on the progression to clinical (overt) proteinuria (urinary albumin excretion rate (UAER) > 300 mg/day, and an increase in UAER of at least 30% from baseline).
Icelandic: Í rannsókninni voru athuguð langtímaáhrif (2 ár) irbesartans á framrás í klíníska (verulega) próteinmigu (útskilnaðarhraði albúmíns í þvagi > 300 mg/sólarhring og aukning um a.m.k.
English: Irbesartan does not inhibit ACE (kininase-II), an enzyme which generates angiotensin-II and also degrades bradykinin into inactive metabolites.
Icelandic: Irbesartan hamlar ekki ACE (kínínasaII), ensími sem leiðir af sér angíótensín-II og brýtur einnig bradýkínín niður í óvirk umbrotsefni.
English: Medicines should not be disposed of via wastewater or household waste.
Icelandic: Engin sérstök fyrirmæli eru um geymsluaðstæður lyfsins Ekki má fleygja lyfjum í skólplagnir eða heimilissorp.
English: Excipients: also contains lactose monohydrate.
Icelandic: Inniheldur einnig laktósaeinhýdrat.
English: Sabervel 150mg film-coated tablets are supplied in blister packs of 28, 56, 90 or 98 film- coated tablets.
Icelandic: Sabervel 150 mg filmuhúðaðar töflur fást með 28, 56, 90 eða 98 filmuhúðuðum töflum í þynnupakkningu.
English: Renal impairment: in patients with renal impairment or those undergoing haemodialysis, the pharmacokinetic parameters of irbesartan are not significantly altered.
Icelandic: Hjá sjúklingum með skerta nýrnastarfsemi eða hjá þeim sem gangast undir blóðskilun breytast lyfjahvarfastuðlar irbesartans óverulega.
English: Tablet core: lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, silica colloidal anhydrous, hypromellose, magnesium stearate, Film-coating: hypromellose, titanium dioxide (E171), macrogol 400
Icelandic: Laktósaeinhýdrat, örkristallaður sellulósi, kroskarmellósnatríum, vatnsfrí kísilkvoða, hýprómellósa, magnesiumsterat.
English: White, concave, round, film-coated tablet with 11 mm diameter.
Icelandic: Hvít, tvíkúpt, kringlótt, filmuhúðuð tafla með 11 mm í þvermál.
English: Sabervel 300mg film-coated tablets are supplied in blister packs of 28, 56, 90 or 98 film- coated tablets.
Icelandic: Sabervel 300 mg filmuhúðaðar töflur fást með 28, 56, 90 eða 98 filmuhúðuðum töflum í þynnupakkningu.
English: White, concave, round, film-coated tablet with 7 mm diameter.
Icelandic: Hvít, tvíkúpt, kringlótt, filmuhúðuð tafla með 7 mm í þvermál.
English: The frequency of the side effects listed below is defined using the following convention: Very common: at least 1 in 10 patients or more Common: at least 1 in 100 and less than 1 in 10 patients Uncommon: at least 1 in 1000 and less than 1 in 100 patients
Icelandic: Koma fyrir hjá að minnsta kosti 1 af hverjum 1.000 en hjá færri en 1 af hverjum 100 sjúklingum.
English: ACE inhibitors, angiotensin II receptor antagonists and dihydropyridine calcium blockers) were added as needed to help achieve the blood pressure goal.
Icelandic: Viðbótarháþrýstingslyfjum (nema ACE-hemlum, angíótensín-II blokkum og dihýdrópýridín kalsíumgangalokum) var bætt við eftir þörfum til þess að stuðla að því að blóðþrýstingsmarkmiði yrði náð.
English: Renal impairment and kidney transplantation: when Sabervel is used in patients with impaired renal function, a periodic monitoring of potassium and creatinine serum levels is recommended.
Icelandic: Mælt er með að mæla kalíum- og kreatíníngildi í sermi reglulega, þegar Sabervel er notað hjá sjúklingum með skerta nýrnastarfsemi.
English: What Sabervel looks like and contents of the pack Sabervel 300 mg film-coated tablets are white, concave, round, film-coated tablets with 11 mm diameter.
Icelandic: Sabervel 300 mg filmuhúðuð tafla er hvít, tvíkúpt, kringlótt, filmuhúðuð tafla með 11 mm í þvermál.
English: jaundice
Icelandic: Skammtar
English: Sabervel 75mg film-coated tablets are supplied in blister packs of 28, 56, 90 or 98 film- coated tablets.
Icelandic: Sabervel 75 mg filmuhúðaðar töflur fást með 28, 56, 90 eða 98 filmuhúðuðum töflum í þynnupakkningu.
English: A lower starting dose (75 mg) should be considered for patients undergoing haemodialysis (see section
Icelandic: Hafa skal í huga að gefa sjúklingum í blóðskilun lægri upphafsskammt (75 mg) (sjá kafla 4.4).
English: The demonstration of renal benefit of Sabervel in hypertensive type 2 diabetic patients is based on studies where irbesartan was used in addition to other antihypertensive agents, as needed, to reach target blood pressure (see sections 4.3, 4.4, 4.5 and 5.1).
Icelandic: Þetta byggist á rannsóknum þar sem irbesartan var notað með öðrum háþrýstingslyfjum eftir þörfum til þess að ná markblóðþrýstingi (sjá kafla 4.3, 4.4, 4.5 og 5.1).
English: White, concave, round, film-coated tablet with 9 mm diameter.
Icelandic: Hvít, tvíkúpt, kringlótt, filmuhúðuð tafla með 9 mm í þvermál.
English: • Uncommon : heart rate increased, flushing, cough, diarrhoea, indigestion/heartburn, sexual dysfunction (problems with sexual performance), chest pain.
Icelandic: Hraður hjartsláttur, andlitsroði, hósti, niðurgangur, meltingartruflanir/nábítur, truflanir á kyngetu og verkur fyrir brjósti.
English: In 1.7% of hypertensive patients with advanced diabetic renal disease treated with irbesartan, a decrease in haemoglobin*, which was not clinically significant, has been observed.
Icelandic: Lækkun hemoglobins*, sem ekki skipti máli klínískt, kom fram hjá 1,7% sjúklinga með háþrýsting sem voru með langt gengna sykursýki með nýrnasjúkdómi og voru á irbesartan meðferð.
English: What Sabervel looks like and contents of the pack Sabervel 150 mg film-coated tablets are white, concave, round, film-coated tablets with 9 mm diameter.
Icelandic: Sabervel 150 mg filmuhúðuð tafla er hvít, tvíkúpt, kringlótt, filmuhúðuð tafla með 9 mm í þvermál.
English: NAME OF THE MEDICINAL PRODUCT Sabervel 75 mg film-coated tablets
Icelandic: HEITI LYFS Sabervel 75 mg filmuhúðaðar töflur.
English: Hypertension and type 2 diabetes with renal disease The “Irbesartan Diabetic Nephropathy Trial (IDNT)” shows that irbesartan decreases the progression of renal disease in patients with chronic renal insufficiency and overt proteinuria.
Icelandic: Háþrýstingur og sykursýki af gerð 2 með nýrnasjúkdómi Rannsókn á irbesartani hjá sykursýkissjúklingum með nýrnakvilla (Irbesartan Diabetic Nephropathy Trial, IDNT) sýndi fram á að irbesartan hægir á framrás nýrnasjúkdóms hjá sjúklingum með langvarandi skerta nýrnastarfsemi og mikla próteinmigu.
English: Exposure to AIIRA therapy during the second and third trimesters is known to induce human fetotoxicity (decreased renal function, oligohydramnios, skull ossification retardation) and neonatal toxicity (renal failure, hypotension, hyperkalaemia).
Icelandic: Vitað er að notkun angíótensín-II blokka á öðrum og þriðja þriðjungi meðgöngu hefur skaðleg áhrif á fóstur (skert starfsemi nýrna, legvatnsbrestur, skert beinmyndun höfuðkúpu) og skaðleg áhrif á nýbura (nýrnabilun, lágþrýstingur, blóðkalíumhækkun).
English: Gastrointestinal disorders: Common:
Icelandic: Aldósterónheilkenni:
English: • salt substitutes containing potassium
Icelandic: saltlíki sem inniheldur kalíum
English: nausea/vomiting
Icelandic: Ógleði/uppköst
English: Mechanism of action: Irbesartan is a potent, orally active, selective angiotensin-II receptor (type AT1) antagonist.
Icelandic: Irbesartan er öflugur sértækur angíótensín-II (gerð AT1) blokki, virkur eftir inntöku.
English: flushing
Icelandic: INNIHALDSLÝSING
English: NAME OF THE MEDICINAL PRODUCT Sabervel 150 mg film-coated tablets
Icelandic: HEITI LYFS Sabervel 150 mg filmuhúðaðar töflur.
English: B e lgië/Belgique/Belgien
Icelandic: Luxe mbourg/Luxemburg
English: Teл.
Icelandic: C.V.
English: NAME OF THE MEDICINAL PRODUCT Sabervel 300 mg film-coated tablets
Icelandic: HEITI LYFS Sabervel 300 mg filmuhúðaðar töflur.
English: Irbesartan and its metabolites are eliminated by both biliary and renal pathways.
Icelandic: Irbesartan og umbrotsefniþess skiljast út bæði með galli og í gegnum nýru.
English: 40 mg of lactose monohydrate per film-coated tablet For the full list of excipients, see section 6.1.
Icelandic: 40 mg af laktósaeinhýdrati í hverri filmuhúðaðri töflu.
English: 6 Dervenakion Str.,
Icelandic: • kalíumuppbót,
English: tachycardia Vascular disorders:
Icelandic: Bólgueyðandi gigtarlyf:
English: 80 mg of lactose monohydrate per film-coated tablet For the full list of excipients, see section 6.1.
Icelandic: 80 mg af laktósaeinhýdrati í hverri filmuhúðaðri töflu.
English: Musculoskeletal and connective tissue disorders: Common:
Icelandic: Þvagræsilyf og önnur blóðþrýstingslækkandi lyf:
English: 20 mg of lactose monohydrate per film-coated tablet For the full list of excipients, see section 6.1.
Icelandic: 20 mg af laktósaeinhýdrati í hverri filmuhúðaðri töflu.
English: Hepatic impairment: in patients with mild to moderate cirrhosis, the pharmacokinetic parameters of irbesartan are not significantly altered.
Icelandic: Hjá sjúklingum með væga eða meðalvæga skorpulifur breytast lyfjahvarfastuðlar irbesartans óverulega.
English: In the 26-week open-label period of this trial the most frequent laboratory abnormalities observed were creatinine increases (6.5%) and elevated CK values in 2% of child recipients.
Icelandic: Hækkuð gildi kreatinins (6,5%) og hækkuð gildi kreatinkinasa (CK)hjá 2% barna sem fengu lyfið.
English: • Patients with high blood pressure and type 2 diabetes with kidney disease
Icelandic: Háþrýstingssjúklingar með sykursýki af gerð 2 og nýrnasjúkdóm:
English: • potassium supplements
Icelandic: 13. LOTUNÚMER
English: Renal impairment: no dosage adjustment is necessary in patients with impaired renal function.
Icelandic: Ekki er nauðsynlegt að breyta skömmtum hjá sjúklingum með skerta nýrnastarfsemi.
English: 5.5 mEq/L) occurred in 29.4% of the patients in the irbesartan 300 mg group and 22% of the patients in the placebo group.
Icelandic: Hjá sykursýkissjúklingum með háþrýsting sem höfðu öralbúminmigu og eðlilega nýrnastarfsemi kom blóðkalíumhækkun (≥ 5,5 mEq/L) fram hjá 29,4% sjúklinga sem fengu 300 mg af irbesartani og 22% sjúklinga í lyfleysuhópnum.
English: Pharmathen International S.A.
Icelandic: Pharmathen Hellas S.A.
English: PSURs
Icelandic: Andlitsroði
English: Cardiac disorders: Uncommon:
Icelandic: Hjarta: Sjaldgæfar:
English: Uncommon:
Icelandic: Framle iðandi:
English: The frequency of the side effects listed below is defined using the following convention: Very common: at least 1 in 10 patients or more
Icelandic: Koma fyrir hjá að minnsta kosti 1 eða fleiri af hverjum 10 sjúklingum.
English: Respiratory, thoracic and mediastinal disorders: Uncommon:
Icelandic: Öndunarfæri, brjósthol og miðmæti:
English: orthostatic hypotension*
Icelandic: Stoðkerfisverkir*
English: ONIVYDE pegylated liposomal
Icelandic: ONIVYDE pegýlerað lípósómlyf
English: 4.3 mg/ml Concentrate for solution for infusion
Icelandic: 4.3 mg/ml
English: Package size
Icelandic: Pakkningarstærð
English: Immediate Packaging
Icelandic: Pakkning
English: MA (EU) Number (Invented) name
Icelandic: EU Númer
English: This is very important.
Icelandic: Þetta er mjög áríðandi.
English: It is therefore important that you know about these medicines too.
Icelandic: Það er því mikilvægt að þú þekkir þessi lyf einnig.
English: This may be in the skin or joints.
Icelandic: Þetta getur verið í húð eða í liðum.
English: A total of 10% of patients had previously used enfuvirtide.
Icelandic: Alls 10% sjúklinga hafði áður notað enfuvirtíð.
English: % White % Black % Asian
Icelandic: % Hvítur % Svartur % Asískur
English: Mechanism unknown.
Icelandic: Verkunarmáti óþekktur.
English: Halofantrine, lumefantrine
Icelandic: Halofantrine, lumefantrin
English: - with ENF (FAS) - without ENF (FAS)
Icelandic: PP - með ENF (FAS) - án ENF (FAS)
English: Number of TPV Score Mutations**
Icelandic: Fjöldi TPV stökkbreytinga**
English: Tipranavir has been used in limited number of patients 65 years or older.
Icelandic: Tipranavir hefur verið notað hjá takmörkuðum fjölda sjúklinga 65 ára og eldri.
English: Antiviral activity in vitro
Icelandic: Veirueyðandi virkni in vitro
English: Autoimmune disorders may occur many months after the start of treatment.
Icelandic: Sjálfsofnæmissjúkdómar geta komið fram mörgum mánuðum eftir að meðferðin hefst.
English: The dose for children, aged 2 to 12 years, will be calculated by the doctor.
Icelandic: Skammturinn fyrir börn á aldrinum 2 til 12 ára verður reiknaður út af lækninum.
English: Alpha 1-adrenoreceptor antagonists Alfuzosin
Icelandic: Alfa 1-adrenviðtakahemill Alfuzosin
English: D-55216 Ingelheim am Rhein Germany
Icelandic: D-55216 Ingelheim am Rhein Þýskalandi
English: Date of latest renewal: 19 June 2015
Icelandic: 19. júní 2015
English: One patient in the tipranavir arm had four mutations.
Icelandic: Einn sjúklingur í tipranavir hópnum var með fjórar stökkbreytingar.
English: Do not use this medicine after the expiry date which is stated on the bottle after EXP.
Icelandic: Ekki skal nota lyfið eftir fyrningardagsetningu sem tilgreind er á glasinu á eftir EXP.
English: Currently available data are described in section 5.1 and 5.2 but no recommendation on a posology can be made.
Icelandic: Fyrirliggjandi upplýsingar eru tilgreindar í kafla 5.1. og 5.2 en ekki er hægt að ráðleggja ákveðna skammta á grundvelli þeirra.
English: Tipranavir is extensively bound to plasma proteins (>99.9%).
Icelandic: Tipranavir er mjög mikið bundið plasmapróteinum (> 99,9%).
English: Dosage of methadone may need to be increased.
Icelandic: Verið getur að þurfi að stækka skammta metadons.
English: The study was prematurely stopped after 60 weeks.
Icelandic: Rannsókninni var hætt eftir 60 vikur, fyrr en áætlað hafði verið.
English: Aptivus is not a cure for HIV infection:
Icelandic: Aptivus er ekki lækning við HIV-sýkingu:
English: ENF Enfuvirtide; FAS Full Analysis Set; PP Per Protocol; APV/rtv Amprenavir/ritonavir; IDV/rtv Indinavir/ritonavir; LPV/rtv Lopinavir/ritonavir; SQV/rtv Saquinavir/ritonavir
Icelandic: ENF Enfuvirtíð; FAS Full Analysis Set; PP Per Protocol; APV/rtv Amprenavir/ritonavir; IDV/rtv Indinavir/ritonavir; LPV/rtv Lopinavir/ritonavir; SQV/rtv Saquinavir/ritonavir
English: Number of Patients Age-Median (years) Gender
Icelandic: Fjöldi sjúklinga Miðaldur (ár) Kyn
English: In addition, most radioactivity (56%) was excreted between 24 and 96 hours after dosing.
Icelandic: Þar að auki var meirihluti geislavirknarinnar (56%) skilinn út á milli 24 til 96 klst. eftir lyfjagjöf.
English: The effects were reversible with termination of treatment.
Icelandic: Áhrifin ganga til baka þegar meðferð er hætt.
English: You should therefore remain in regular contact with your doctor.
Icelandic: Því þarf að hafa samband við lækninn reglulega.
English: Disulfiram/metronidazole
Icelandic: Disulfiram/metronidazol
English: Phosphodiesterase 5 (PDE5) inhibitors Sildenafil
Icelandic: Fosfódíesterasa 5 (PDE5) hemlar Sildenafil
English: Your doctor, together with you, will decide which other medicines you should take.
Icelandic: Læknirinn mun ákveða, með þér, hvaða önnur lyf þú átt að taka.
English: This will be based on the child's body surface area in metres squared.
Icelandic: Þetta verður byggt á yfirborðsflatarmáli barnsins í fermetrum.
English: Dosing by means of the measuring device remains accurate even when crystals are observed.
Icelandic: Skömmtun með mælingaráhaldinu er nákvæm jafnvel þótt kristallar sjáist.
English: C-tipranavir human study (500 mg
Icelandic: C-tipranavir rannsókn á mönnum (500 mg
English: In both studies, a total of 67% patient viruses were resistant and 22% were possibly resistant to the pre-selected comparator PIs.
Icelandic: Í báðum rannsóknunum voru alls 67% af veirum sjúklinganna ónæm og 22% var hugsanlega ónæm fyrir forvöldum próteasahemlum sem voru til viðmiðunar.
English: Tipranavir demonstrates antiviral activity in vitro against a broad panel of HIV-1 group M non-clade B isolates (A, C, D, F, G, H, CRF01 AE, CRF02 AG, CRF12 BF).
Icelandic: Tipranavir hefur veirueyðandi virkni in vitro gegn breiðum hópi óhjúpaðra (non-clade) B einangraðra stofna HIV-1 veiru af flokki M (A, C, D, F, G, H, CRF01 AE, CRF02 AG, CRF12 BF).
English: No information is available for the parameters AUC and Cmax.
Icelandic: Engar upplýsingar liggja fyrir um gildin AUC og Cmax.
English: Baseline HIV-1 RNA (log10 copies/ml)
Icelandic: Upphafsgildi HIV-1 RNA (log10 eintök/ml)
English: Once the bottle is opened the contents must be used within 60 days (stored below 25°C).
Icelandic: Eftir að glasið hefur fyrst verið opnað verður að nota innihaldið innan 60 daga (geymt við lægra hitastig en 25°C).
English: Very common (≥ 1/10), common (≥ 1/100 to 1/10), uncommon (≥1/1,000 to 1/100), rare (≥1/10,000 to 1/1,000)
Icelandic: Mjög algengar (≥ 1/10), algengar (≥ 1/100 til 1/10), sjaldgæfar (≥ 1/1.000 til < 1/100), mjög sjaldgæfar (≥ 1/10.000 til < 1/1.000)
English: Your child's doctor will test for these changes.
Icelandic: Læknir barnsins mun gera próf vegna breytinganna.
English: Aptivus is supplied in bottles containing 120 capsules.
Icelandic: Aptivus er fáanlegt í glösum sem innihalda 120 hylki.
English: Data on the 29 patients who switched to capsules during the first 48 weeks are presented.
Icelandic: Gögn fyrir sjúklingana 29 sem skiptu yfir í hylkin á fyrstu 48 vikunum eru sýnd.
English: Only a few metabolites were found in plasma, and all were at trace levels (0.2% or less of the plasma radioactivity).
Icelandic: Aðeins fundust fá umbrotsefni í plasma og voru öll rétt við greinanleg mörk (0,2% eða minna af plasmageislavirkni).
English: Patients should be instructed to observe closely for crystals.
Icelandic: Gefa á sjúklingum fyrirmæli um að fylgjast vel með kristöllum.
English: For this reason it is very important that you tell your doctor about any changes in your health.
Icelandic: Vegna þessa er mjög nauðsynlegt að segja lækninum frá öllum breytingum sem verða á heilsunni.
English: % Male
Icelandic: % með einhverju
English: - abacavir and zidovudine.
Icelandic: - abacavir og zidovudin.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/05/315/001
Icelandic: MARKAÐSLEYFISNÚMER EU/1/05/315/001
English: Aptivustreatment is therefore appropriate for your child.
Icelandic: Því er meðferð með Aptivus viðeigandi fyrir barnið þitt.
English: Tipranavir Cmin ↓ 61% (compared to historical data)
Icelandic: Tipranavir Cmin ↓ 61 % (borið saman við fyrirliggjandi gögn)
English: If Aptivus has been prescribed for your child, please note that all information in this leaflet is addressed to your child (in this case please read “your child” instead of “you”).
Icelandic: Vinsamlega athugið að hafi Aptivus verið ávísað handa barninu þínu eiga allar upplýsingar í fylgiseðlinum við um barnið þitt (vinsamlega lesið „barnið þitt“ í stað „þú“ í þessu tilviki).
English: Mutations at protease codons 33, 82, 84 and 90
Icelandic: - Stökkbreyting á próteasatáknum 33, 82, 84 og 90
English: Until you exchange the bottle, please continue to give your child their usual doses of Aptivus oral solution.
Icelandic: Þar til þú ert búin að skipta glasinu út skaltu halda áfram að gefa barninu þínu venjulega skammta af Aptivus mixtúrunni.
English: If you are older than 65 years your doctor will exercise caution when prescribing Aptivus soft capsules to you and will closely monitor your therapy.
Icelandic: Ef þú ert eldri en 65 ára mun læknirinn gæta varúðar við ávísun Aptivus hylkja fyrir þig og mun fylgjast náið með meðferðinni.
English: Possible side effects:
Icelandic: Hugsanlegar aukaverkanir:
English: MARKETING AUTHORISATION NUMBER(S) EU/1/05/315/002
Icelandic: MARKAÐSLEYFISNÚMER EU/1/05/315/002
English: It belongs to a group of medicines called protease inhibitors and is used in the treatment of Human Immunodeficiency Virus (HIV) infection.
Icelandic: Það tilheyrir flokki lyfja sem kallast próteasahemlar og er notað í meðferð við HIV-sýkingu (Human Immunodeficiency Virus).
English: The mean half-life was 5.5 (females) or 6.0 hours (males).
Icelandic: Helmingunartími var að meðaltali á bilinu 5,5 (konur) til 6,0 klst. (karlar).