FrancophonIA/ELRC3.0 huggingface dataset:
English: The addition of 12.5 mg hydrochlorothiazide to 300 mg irbesartan once daily in patients not adequately controlled on 300 mg irbesartan alone resulted in further placebo-corrected diastolic blood pressure reductions at trough (24 hours post-dosing) of 6.1 mmHg.
Icelandic: Ef 12,5 mg af hýdróklórtíazíði er bætt við 300 mg skammt af irbesartani einu sinni á sólarhring hjá sjúklingum, þegar ekki hefur náðst stjórn á blóðþrýstingi með 300 mg skammti af irbesartani einu sér, verður frekari lækkun á þanbilsþrýstingi við lágmarksáhrif lyfsins (24 klst. eftir gjöf) og nemur hún 6,1 mmHg, leiðrétt m.t.t. lyfleysu.
English: (It is also better to avoid Ifirmacombi in early pregnancy - see pregnancy section) - if you have severe liver or kidney problems - if you have difficulty in producing urine - if your doctor determines that you have persistently high calcium or low potassium levels in your blood - if you have diabetes or impaired kidney function and you are treated with a blood pressure lowering medicine containing aliskiren
Icelandic: - ef þú ert með ofnæmi fyrir hýdróklórtíazíði eða fyrir einhverjum öðrum lyfjum sem eru súlfónamíðafleiður - eftir þriðja mánuð meðgöngu (Einnig er betra að forðast notkun Ifirmacombi snemma á meðgöngu - sjá kaflann um meðgöngu) - ef þú ert með alvarlega lifrar- eða nýrnasjúkdóma - ef þú átt í erfiðleikum með þvaglát - ef læknirinn metur að þú hafir langvarandi há kalsíum eða lág kalíum gildi í blóði - ef þú ert með sykursýki eða skerta nýrnastarfsemi og ert á meðferð með blóðþrýstingslækkandi lyfi sem inniheldur aliskiren.
English: Hydrochlorothiazide is one of a group of medicines (called thiazide diuretics) that causes increased urine output and so causes a lowering of blood pressure.
Icelandic: Hýdróklórtíazíð tilheyrir flokki lyfja (svonefndra tíazíð þvagræsilyfja) sem auka þvagútskilnað úr líkamanum og hafa þannig blóðþrýstingslækkandi áhrif.
English: The antihypertensive effect of Ifirmacombi may be increased with the concomitant use of other antihypertensive agents.
Icelandic: Blóðþrýstingslækkandi áhrif Ifirmacombi geta aukist við samtímis notkun annarra blóðþrýstingslækkandi lyfja.
English: Ifirmacombi 150 mg/12.5 mg will usually be prescribed by your doctor when your previous treatment did not reduce your blood pressure enough.
Icelandic: Í flestum tilvikum mun læknirinn ávísa Ifirmacombi 150 mg/12,5 mg þegar fyrri meðferð lækkaði blóðþrýstinginn ekki nægjanlega mikið.
English: As for any patient receiving diuretic therapy, periodic determination of serum electrolytes should be performed at appropriate intervals.
Icelandic: Þegar sjúklingar nota þvagræsilyf á að mæla elektrólýta í sermi með reglulegu millibili.
English: Exposure to AIIRA therapy during the second and third trimesters is known to induce human foetotoxicity (decreased renal function, oligohydramnios, skull ossification retardation) and neonatal toxicity (renal failure, hypotension, hyperkalaemia) (see section 5.3).
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) (sjá kafla 5.3).
English: Doses higher than 300 mg irbesartan/25 mg hydrochlorothiazide once daily are not recommended.
Icelandic: Ekki er mælt með stærri skömmtum en 300 mg af irbesartani/25 mg af hýdróklórtíazíði einu sinni á sólarhring.
English: The recomended dose of Ifirmacombi 300 mg /12.5 mg is one tablet a day.
Icelandic: Ráðlagður skammtur af Ifirmacombi 300 mg/12,5 mg er ein tafla á sólarhring.
English: When measured by ambulatory blood pressure monitoring, the trough to peak effects of Ifirmacombi 150 mg/12.5 mg were 100%.
Icelandic: Þegar mældur var blóðþrýstingur hjá sjúklingum með fótavist eftir gjöf 150 mg/12,5 mg skammts af Ifirmacombi hlutfall lágmarksáhrifa/hámarksáhrifa (trough to peak) 100%.
English: Ifirmacombi 150 mg/12.5 mg film-coated tablets Ifirmacombi 300 mg/12.5 mg film-coated tablets Ifirmacombi 300 mg/25 mg film-coated tablets
Icelandic: Ifirmacombi 150 mg/12,5 mg filmuhúðaðar töflur Ifirmacombi 300 mg/12,5 mg filmuhúðaðar töflur
English: Ifirmacombi is not indicated in patients with severe hepatic impairment.
Icelandic: Ifirmacombi er ekki ætlað sjúklingum með verulega skerta lifrarstarfsemi.
English: Ifirmacombi 300 mg/25 mg will usually be prescribed by your doctor when your previous treatment did not reduce your blood pressure enough.
Icelandic: Í flestum tilvikum mun læknirinn ávísa Ifirmacombi 300 mg/25 mg þegar fyrri meðferð lækkaði blóðþrýstinginn ekki nægjanlega mikið.
English: Potassium-sparing diuretics, potassium supplements or potassium-containing salts substitutes should be co-administered cautiously with Ifirmacombi (see section 4.5).
Icelandic: Gæta skal varúðar við samtímis notkun kalíumsparandi þvagræsilyfja, kalíumuppbótar eða saltuppbótar sem inniheldur kalíum og Ifirmacombi (sjá kafla 4.5).
English: If you get any of the above symptoms or get short of breath, stop taking Ifirmacombi and contact your doctor immediately.
Icelandic: Ef þú færð eitthvert ofantalinna einkenna eða ef þú átt erfitt með öndun skaltu hætta töku
English: Ifirmacombi 300 mg/12.5 mg: mannitol, hydroxypropylcellulose, low-substituted hydroxypropylcellulose, sodium starch glycolate, talc, macrogol 6000, hydrogenated castor oil in the tablet core and polyvinyl alcohol, titanium dioxide (E171), macrogol, talc in the film-coating.
Icelandic: Ifirmacombi 300 mg/12,5 mg: mannitól, hýdroxýprópýlsellulósi, umbreyttur hýdroxýprópýlsellulósi, natríumsterkjuglýkólat, talkúm, makrógól 6000, hert laxerolía í töflukjarnanum og pólývínýlalkóhól, títantvíoxíð (E171), makrógól og talkúm í filmuhúðinni.
English: In patients not adequately controlled on 25 mg hydrochlorothiazide alone, the addition of irbesartan gave an added placebo-subtracted systolic/diastolic mean reduction of 11.1/7.2 mmHg.
Icelandic: Hjá þeim sjúklingum þar sem meðferð með 25 mg skammti af hýdróklórtíazíði einu sér hefur ekki reynst nægjanleg til að ná viðunandi stjórn á blóðþrýstingi hefur slagbils- /þanbilsþrýstingur lækkað enn frekar um 11,1/7,2 mmHg að meðaltali, leiðrétt m.t.t. lyfleysu, þegar irbesartan er bætt við meðferð.
English: Hypotension - Volume-depleted patients:
Icelandic: Lágur blóðþrýstingur - sjúklingar með skert blóðrúmmál:
English: Date of first authorisation: 04 March 2011 Date of latest renewal: 19 November 2015
Icelandic: 04. mars 2011
English: Ifirmacombi 300 mg/12.5 mg will usually be prescribed by your doctor when your previous treatment did not reduce your blood pressure enough.
Icelandic: Í flestum tilvikum mun læknirinn ávísa Ifirmacombi 300 mg/12,5 mg þegar fyrri meðferð lækkaði blóðþrýstinginn ekki nægjanlega mikið.
English: As with other vasodilators, special caution is indicated in patients suffering from aortic or mitral stenosis, or obstructive hypertrophic cardiomyopathy.
Icelandic: Eins og við á um önnur æðavíkkandi lyf þarf að gæta sérstakrar varúðar hjá sjúklingum með ósæðareða míturlokuþrengsli eða hjartavöðvakvilla með útstreymishindrun.
English: Digitalis glycosides: thiazide induced hypokalaemia or hypomagnaesemia favour the onset of digitalis-induced cardiac arrhythmias (see section 4.4);
Icelandic: Kalíumskortur í blóði vegna tíazíðs eða magnesíumskortur geta komið af stað hjartsláttaróreglu af völdum dígitalisnotkunar (sjá kafla 4.4);
English: Ifirmacombi 300 mg/25 mg Pale pink, biconvex, capsule shaped, film-coated tablets (tablets).
Icelandic: Ifirmacombi 300 mg/25 mg Fölbleikar, tvíkúptar, hylkislaga, filmuhúðaðar töflur (töflur).
English: Medicinal products affected by serum potassium disturbances:
Icelandic: Lyf sem röskun á kalíum í sermi hefur áhrif á:
English: Based on available data from epidemiological studies, cumulative dosedependent association between HCTZ and NMSC has been observed.
Icelandic: Byggt á fyrirliggjandi upplýsingum úr faraldsfræðilegum rannsóknum hafa komið í ljós skammtaháð tengsl við uppsafnaðan skammt milli hydrochlorothiazids og húðkrabbameins sem ekki er sortuæxli.
English: EU/1/11/673/017 (14 film-coated tablets) EU/1/11/673/018 (28 film-coated tablets) EU/1/11/673/019 (30 film-coated tablets) EU/1/11/673/020 (56 film-coated tablets) EU/1/11/673/021 (56 x 1 film-coated tablets) EU/1/11/673/022 (84 film-coated tablets) EU/1/11/673/023 (90 film-coated tablets) EU/1/11/673/024 (98 film-coated tablets)
Icelandic: EU/1/11/673/021 (56 x 1 filmuhúðuð tafla) EU/1/11/673/022 (84 filmuhúðaðar töflur) EU/1/11/673/023 (90 filmuhúðaðar töflur) EU/1/11/673/024 (98 filmuhúðaðar töflur)
English: Due to the hydrochlorothiazide component, Ifirmacombi is not recommended for patients with severe renal dysfunction (creatinine clearance < 30 ml/min).
Icelandic: Ifirmacombi á ekki að nota handa sjúklingum með verulega skerta nýrnastarfsemi (kreatínínúthreinsun < 30 ml/mín.)
English: Each Ifirmacombi 300 mg/25 mg film-coated tablet contains 300 mg irbesartan (as irbesartan hydrochloride) and 25 mg hydrochlorothiazide.
Icelandic: Hver Ifirmacombi 300 mg/25 mg filmuhúðuð tafla inniheldur 300 mg af irbesartani (sem irbesartanhýdróklóríð) og 25 mg af hýdróklórtíazíði.
English: Metabolic and endocrine effects:
Icelandic: Áhrif á efnaskipti og innkirtla:
English: Not known: vertigo, paraesthesia, light-headedness, restlessness
Icelandic: svimi, náladofi, vægur svimi, eirðarleysi
English: - Ifirmacombi 150 mg/12.5 mg may be administered in patients whose blood pressure is not adequately controlled with hydrochlorothiazide or irbesartan 150 mg alone; - Ifirmacombi 300 mg/12.5 mg may be administered in patients insufficiently controlled by irbesartan 300 mg or by Ifirmacombi 150 mg/12.5 mg. - Ifirmacombi 300 mg/25 mg may be administered in patients insufficiently controlled by Ifirmacombi 300 mg/12.5 mg.
Icelandic: - Ifirmacombi 300 mg/12,5 mg má gefa sjúklingum ef 300 mg af irbesartani eða Ifirmacombi 150 mg/12,5 mg reynist ekki nægjanlegt til að ná stjórn á blóðþrýstingi.
English: Each Ifirmacombi 150 mg/12.5 mg film-coated tablet contains 150 mg irbesartan (as irbesartan hydrochloride) and 12.5 mg hydrochlorothiazide.
Icelandic: Hver Ifirmacombi 150 mg/12,5 mg filmuhúðuð tafla inniheldur 150 mg af irbesartani (sem irbesartanhýdróklóríð) og 12,5 mg af hýdróklórtíazíði.
English: Ifirmacombi 300 mg/25 mg film-coated tablets Pale pink, biconvex, capsule shaped, film-coated tablets.
Icelandic: Ifirmacombi 300 mg/25 mg filmuhúðaðar töflur Fölbleikar, tvíkúptar, hylkislaga, filmuhúðaðar töflur.
English: Once daily dosing with 150 mg irbesartan and 12.5 mg hydrochlorothiazide gave systolic/diastolic mean placebo-adjusted blood pressure reductions at trough (24 hours post-dosing) of 12.9/6.9 mmHg in patients with mild-to-moderate hypertension.
Icelandic: Við gjöf 150 mg af irbesartani og 12,5 mg af hýdróklórtíazíði einu sinni á sólarhring hjá sjúklingum með vægan eða miðlungi mikinn háþrýsting varð lækkun á slagbils-/þanbilsþrýstingi við lágmarksáhrif lyfsins (24 klst. eftir gjöf) sem nam að meðaltali 12,9/6,9 mmHG, leiðrétt m.t.t. lyfleysu.
English: Side effects reported since the launch of the combination of Irbesartan and Hydrochlorothiazide Some undesirable effects have been reported since marketing of Ifirmacombi.
Icelandic: Aukaverkanir sem tilkynnt hefur verið um eftir markaðssetningu samsetningar irbesartans og hýdróklórtíazíðs
English: EU/1/11/673/001 (14 film-coated tablets) EU/1/11/673/002 (28 film-coated tablets) EU/1/11/673/003 (30 film-coated tablets) EU/1/11/673/004 (56 film-coated tablets) EU/1/11/673/005 (56 x 1 film-coated tablets) EU/1/11/673/006 (84 film-coated tablets) EU/1/11/673/007 (90 film-coated tablets) EU/1/11/673/008 (98 film-coated tablets)
Icelandic: EU/1/11/673/005 (56 x 1 filmuhúðuð tafla) EU/1/11/673/006 (84 filmuhúðaðar töflur) EU/1/11/673/007 (90 filmuhúðaðar töflur) EU/1/11/673/008 (98 filmuhúðaðar töflur)
English: EU/1/11/673/009 (14 film-coated tablets) EU/1/11/673/010 (28 film-coated tablets) EU/1/11/673/011 (30 film-coated tablets) EU/1/11/673/012 (56 film-coated tablets) EU/1/11/673/013 (56 x 1 film-coated tablets) EU/1/11/673/014 (84 film-coated tablets) EU/1/11/673/015 (90 film-coated tablets) EU/1/11/673/016 (98 film-coated tablets)
Icelandic: EU/1/11/673/013 (56 x 1 filmuhúðuð tafla) EU/1/11/673/014 (84 filmuhúðaðar töflur) EU/1/11/673/015 (90 filmuhúðaðar töflur) EU/1/11/673/016 (98 filmuhúðaðar töflur)
English: Each film-coated tablet contains 300 mg irbesartan (as irbesartan hydrochloride) and 25 mg hydrochlorothiazide.
Icelandic: Hver filmuhúðuð tafla inniheldur 300 mg af irbesartani (sem irbesartanhýdróklóríð) og 25 mg af hýdróklórtíazíði.
English: Ifirmacombi is a combination of an angiotensin-II receptor antagonist, irbesartan, and a thiazide diuretic, hydrochlorothiazide.
Icelandic: Ifirmacombi inniheldur blöndu af angíótensín-II blokka, irbesartani, og tíazíð þvagræsilyfi, hýdróklórtíazíði.
English: Sodium:
Icelandic: Kalsíumsölt:
English: However, in patients with mild to moderate renal impairment (creatinine clearance ≥ 30 ml/min but < 60 ml/min) this fixed dose combination should be administered with caution.
Icelandic: Hins vegar skal gæta varúðar við gjöf þessarar föstu samsetningu virkra efna hjá sjúklingum með væga til miðlungi skerta nýrnastarfsemi (kreatínínúthreinsun ≥ 30 ml/mín. en < 60 ml/mín.).
English: The trough to peak effects measured by cuff during office visits were 68% and 76% for Ifirmacombi 150 mg/12.5 mg and Ifirmacombi 300 mg/12.5 mg, respectively.
Icelandic: Hlutfall lágmarksáhrifa/hámarksáhrifa (trough to peak) var 68% eftir gjöf Ifirmacombi 150 mg/12,5 mg þegar blóðþrýstingur var mældur með manséttumæli hjá sjúklingum við komu á læknastofu, en 76% eftir gjöf Ifirmacombi 300 mg/12,5 mg.
English: Ifirmacombi 300 mg/25 mg tablets Irbesartan/Hydrochlorothiazide
Icelandic: Ifirmacombi 300 mg/25 mg töflur irbesartan/hýdróklórtíazíð
English: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Icelandic: húðkrabbamein sem ekki er sortuæxli ótilgreind (einnig blöðrur og separ)
English: Ifirmacombi 300 mg/12.5 mg film-coated tablets White, biconvex, capsule shaped, film-coated tablets.
Icelandic: Ifirmacombi 300 mg/12,5 mg filmuhúðaðar töflur Hvítar, tvíkúptar, hylkislaga, filmuhúðaðar töflur.
English: How to take Ifirmacombi
Icelandic: Hvernig geyma á Ifirmacombi
English: Ifirmacombi 300 mg/12.5 mg White, biconvex, capsule shaped, film-coated tablets (tablets).
Icelandic: Ifirmacombi 300 mg/12,5 mg Hvítar, tvíkúptar, hylkislaga, filmuhúðaðar töflur (töflur).
English: Corticosteroids, ACTH: electrolyte depletion, particularly hypokalaemia, may be increased;
Icelandic: Elektrólýtatap, sérstaklega blóðkalíumskortur, getur aukist;
English: Dosage of Ifirmacombi 300 mg/25 mg
Icelandic: Skömmtun Ifirmacombi 300 mg/25 mg
English: No dosage adjustment is necessary in patients with renal impairment whose renal creatinine clearance is ≥ 30 ml/min (see sections 4.3 and 4.4).
Icelandic: Ifirmacombi samhliða lyfjum sem innihalda aliskiren hjá sjúklingum með sykursýki eða skerta nýrnastarfsemi (GFR < 60 ml/mín/1,73 m2) (sjá kafla 4.5 og 5.1).
English: Not known: depression, sleep disturbances Non-melanoma skin cancer: Based on available data from epidemiological studies, cumulative dosedependent association between HCTZ and NMSC has been observed (see also sections 4.4 and
Icelandic: Byggt á fyrirliggjandi upplýsingum úr faraldsfræðilegum rannsóknum hafa komið í ljós skammtaháð tengsl við uppsafnaðan skammt milli hydrochlorothiazids og húðkrabbameins sem ekki er sortuæxli (sjá einnig kafla 4.4 og 5.1).
English: Table 2: Adverse reactions reported with the use of irbesartan alone Blood and lymphatic system disorders
Icelandic: Aukaverkanir sem greint hefur verið frá við notkun irbesartans eins sér Blóð og eitlar
English: Hydrochlorothiazide contained in this medicinal product could produce a positive analytic result in an anti-doping test.
Icelandic: Vegna hýdróklórtíazíð innihalds lyfsins geta niðurstöður úr lyfjaprófum orðið jákvæðar.
English: What Ifirmacombi contains - The active substances are irbesartan and hydrochlorothiazide.
Icelandic: - Virku innihaldsefnin eru irbesartan og hýdróklórtíazíð.
English: Side effects reported in clinical studies for patients treated with Ifirmacombi were:
Icelandic: Aukaverkanirnar sem tilkynnt hefur verið um í klínískum rannsóknum á sjúklingum sem fengu
English: Ifirmacombi 300 mg/12.5 mg tablets Irbesartan/Hydrochlorothiazide
Icelandic: Ifirmacombi 300 mg/12,5 mg töflur irbesartan/hýdróklórtíazíð
English: Each Ifirmacombi 300 mg/12.5 mg film-coated tablet contains 300 mg irbesartan (as irbesartan hydrochloride) and 12.5 mg hydrochlorothiazide.
Icelandic: Hver Ifirmacombi 300 mg/12,5 mg filmuhúðuð tafla inniheldur 300 mg af irbesartani (sem irbesartanhýdróklóríð) og 12,5 mg af hýdróklórtíazíði.
English: Not known: weakness, muscle spasm
Icelandic: þróttleysi, vöðvakrampar
English: Pressor amines (e.g. noradrenaline): the effect of pressor amines may be decreased, but not sufficiently to preclude their use;
Icelandic: Amínur sem hafa áhrif á blóðþrýsting ((pressor amines) t.d. noradrenalín):
English: Not known: electrolyte imbalance (including hypokalaemia and hyponatraemia, see section 4.4), hyperuricaemia, glycosuria, hyperglycaemia, increases in cholesterol and triglycerides
Icelandic: truflun á saltajafnvægi (þ.m.t. lækkun á kalíum í blóði og lækkun á natríum í blóði, sjá kafla 4.4), þvagsýrudreyri, sykurmiga, blóðsykurshækkun, hækkun á kólesteróli og þríglýseríðum
English: Ifirmacombi 300 mg/25 mg film-coated tablets Irbesartan/Hydrochlorothiazide
Icelandic: Ifirmacombi 300 mg/25 mg filmuhúðaðar töflur irbesartan/hýdróklórtíazíð
English: Ifirmacombi 150 mg/12.5 mg film-coated tablets Pale pink, biconvex, oval, film-coated tablets.
Icelandic: Ifirmacombi 150 mg/12,5 mg filmuhúðaðar töflur Fölbleikar, tvíkúptar, sporöskjulaga, filmuhúðaðar töflur.
English: Ifirmacombi 300 mg/12.5 mg film-coated tablets Film coating:
Icelandic: Ifirmacombi 300 mg/12,5 mg filmuhúðaðar töflur Filmuhúð:
English: Each film-coated tablet contains 150 mg irbesartan (as irbesartan hydrochloride) and 12.5 mg hydrochlorothiazide.
Icelandic: Hver filmuhúðuð tafla inniheldur 150 mg af irbesartani (sem irbesartanhýdróklóríð) og 12,5 mg af hýdróklórtíazíði.
English: Ifirmacombi 150 mg/12.5 mg tablets Irbesartan/Hydrochlorothiazide
Icelandic: Ifirmacombi 150 mg/12,5 mg töflur irbesartan/hýdróklórtíazíð
English: Other medicines and Ifirmacombi
Icelandic: Notkun annarra lyfja samhliða Ifirmacombi
English: Each film-coated tablet contains 300 mg irbesartan (as irbesartan hydrochloride) and 12.5 mg hydrochlorothiazide.
Icelandic: Hver filmuhúðuð tafla inniheldur 300 mg af irbesartani (sem irbesartanhýdróklóríð) og 12,5 mg af hýdróklórtíazíði.
English: Additional information on hydrochlorothiazide interactions: When administered concurrently, the following medicinal products may interact with thiazide diuretics:
Icelandic: Önnur rannsókn sýndi hugsanleg tengsl milli varakrabbameins (flöguþekjukrabbameins) og útsetningar fyrir hydrochlorothiazidi:
English: Not known: anaphylactic reactions, toxic epidermal necrolysis, necrotizing angitis (vasculitis, cutaneous vasculitis), cutaneous lupus erythematosus-like reactions, reactivation of cutaneous lupus erythematosus, photosensitivity reactions, rash, urticaria
Icelandic: bráðaofnæmi, drep í húðþekju, æðabólga með drepi (æðabólga, æðabólga í húð), húðviðbrögð sem líkjast rauðum úlfum, endurvakning rauðra úlfa, ljósnæmi, útbrot, ofsakláði
English: Ifirmacombi 300 mg/12.5 mg film-coated tablets Irbesartan/Hydrochlorothiazide
Icelandic: Ifirmacombi 300 mg/12,5 mg filmuhúðaðar töflur irbesartan/hýdróklórtíazíð
English: Ifirmacombi 150 mg/12.5 mg film-coated tablets Irbesartan/Hydrochlorothiazide
Icelandic: Ifirmacombi 150 mg/12,5 mg filmuhúðaðar töflur irbesartan/hýdróklórtíazíð
English: Pregnancy
Icelandic: niðurgangur
English: Not known: pancreatitis, anorexia, diarrhoea, constipation, gastric irritation, sialadenitis, loss of appetite
Icelandic: brisbólga, lystarleysi, niðurgangur, hægðatregða, magaerting, munnvatnskirtlabólga, minnkuð matarlyst
English: In patients with creatinine clearance < 20 ml/min, the elimination half-life of hydrochlorothiazide was reported to increase to 21 hours.
Icelandic: Hjá sjúklingum með kreatínínúthreinsun < 20 ml/mín.
English: Table 3: Adverse reactions reported with the use of hydrochlorothiazide alone Investigations
Icelandic: Aukaverkanir sem greint hefur verið frá við notkun hýdróklórtíazíðs eins sér Rannsóknaniðurstöður
English: Not known: aplastic anaemia, bone marrow depression, neutropenia/agranulocytosis, haemolytic anaemia, leucopenia, thrombocytopenia
Icelandic: vanmyndunarblóðleysi, beinmergsbæling, hlutleysiskyrningafæð / kyrningafæð, rauðalosblóðleysi, hvítkornafæð, blóðflagnafæð
English: Other antihypertensive agents:
Icelandic: Önnur blóðþrýstingslækkandi lyf:
English: ANNEX II
Icelandic: Angíótensín II blokkar
English: Non-steroidal anti-inflammatory drugs: the administration of a non-steroidal anti-inflammatory drug may reduce the diuretic, natriuretic and antihypertensive effects of thiazide diuretics in some patients;
Icelandic: Samtímis notkun bólgueyðandi gigtarlyfja getur dregið úr þvagræsandi áhrifum, útskilnaði natríums í þvagi og blóðþrýstingslækkandi verkun tíazíð þvagræsilyfja hjá sumum sjúklingum;
English: Common side effects (may affect up to 1 in 10 people): - nausea/vomiting - abnormal urination - fatigue - dizziness (including when getting up from a lying or sitting position) - blood tests may show raised levels of an enzyme that measures the muscle and heart function
Icelandic: - þreyta - svimi (þar með talið þegar risið er upp úr liggjandi eða sitjandi stöðu) - blóðrannsóknir geta sýnt aukið magn ensíms (kreatínkínasa), sem er mælikvarði á vöðva- og hjartastarfsemi eða aukið magn efna (blóðnitur og kreatínín í blóði) sem eru mælikvarði á starfsemi nýrna.
English: Hepatobiliary disorders:
Icelandic: Carbamazepín:
English: Psychiatric disorders:
Icelandic: Dígitalisglýkósíðar:
English: Non-melanoma skin cancer
Icelandic: blóðkalíumhækkun
English: MA (EU) Number (Invented) name Strength Pharmaceutical Form Route of Administration
Icelandic: ESB markaðsleyfisnúmer
English: EU/1/19/1409/001 Pegfilgrastim Mundipharma
Icelandic: EU/1/19/1409/001
English: 0.6 ml (10 mg/ml) 1 pre-filled syringe
Icelandic: Til notkunar undir húð áfyllt sprauta (gler) 0,6 ml (10 mg/ml)
English: Pack size
Icelandic: Mundipharma
English: Vorgartenstraße 206B
Icelandic: Vorgartenstraße 206B AT-1020
English: The Netherlands Janssen-Cilag BV Dr. Paul Janssenweg
Icelandic: Janssen-Cilag BV Dr. Paul Janssenweg
English: Janssen Farmacêutica Portugal, Lda Estrada Consiglieri Pedroso, 69 A, Queluz de Baixo2734 503 Barcarena Portugal
Icelandic: Janssen Farmacêutica Portugal, Lda Estrada Consiglieri Pedroso, 69 A, Queluz de Baixo2734 503 Barcarena
English: Haldol - Janssen Decanoat Depot
Icelandic: Haldol - Janssen
English: Janssen Farmacêutica Portugal, Lda Estrada Consiglieri Pedroso, 69 A, Queluz de Baixo 2734 503 Barcarena Portugal
Icelandic: Janssen Farmacêutica Portugal, Lda Estrada Consiglieri Pedroso, 69 A, Queluz de Baixo
English: Buckinghamshire
Icelandic: Danmörk
English: Serenase Dekanoat 100 mg/ml
Icelandic: Dekanoat 100 mg/ml
English: HP12 4EG,
Icelandic: High Wycombe Buckinghamshire HP12 4EG,
English: (cannot be estimated from the available data)
Icelandic: (ekki hægt að áætla tíðni út frá fyrirliggjandi gögnum)
English: The potential risk for pregnant women is unknown.
Icelandic: Hugsanleg áhætta fyrir þungaðar konur er ekki þekkt.
English: This results in protection against the disease.
Icelandic: Þetta veitir vernd gegn sjúkdóminum.
English: Date of latest renewal: 18 September 2017
Icelandic: 18. september 2017
English: Pack sizes of 1 or 10 syringes.
Icelandic: Pakkningastærðir eru 1 eða 10 sprautur.
English: Kanamycin is used in early manufacturing process and is removed during the later stages of manufacture.
Icelandic: Kanamýsín er notað snemma í framleiðsluferlinu og er síðan fjarlægt á síðari framleiðslustigum.
English: 50/50/50 micrograms
Icelandic: 50/50/50 míkrógrömm
English: See section 5.1 for information on protection against specific group B strains.
Icelandic: Sjá kafla 5.1 varðandi upplýsingar um vörn gegn tilteknum stofnum af gerð B.