FrancophonIA/ELRC3.0 huggingface dataset:
English: Mean serum concentration profiles at steady state in treated RA patients were Cmax of 2.4 mg/l vs. 2.6 mg/l, Cmin of 1.2 mg/l vs. 1.4 mg/l, and partial AUC of 297 mgh/l vs. 316 mgh/l for 50 mg LIFMIOR once weekly (n=21) vs. 25 mg LIFMIOR twice weekly (n=16), respectively.
Icelandic: klst./l og hjá iktsýkisjúklingum á meðferð með 25 mg LIFMIOR 2svar í viku (n=16) var Cmax 2,6 mg/l, Cmin 1,4 mg/l og AUC var 316 mg•klst./l. Í opinni, stakskammta víxlunarrannsókn (crossover study) á heilbrigðum sjálfboðaliðum í tveimur meðhöndlunarhópum kom fram að etanercept 50 mg/ml inndæling í eitt skipti jafngilti tveimur samtímis inndælingum með 25 mg/ml.
English: CNS demyelinating events suggestive of multiple sclerosis or localised demyelinating conditions, such as optic neuritis and transverse myelitis (see section 4.4), peripheral demyelinating events, including GuillainBarré syndrome, chronic inflammatory demyelinating polyneuropathy, demyelinating polyneuropathy, and multifocal motor neuropathy (see section 4.4), seizure
Icelandic: Mergslíðurssvipting í miðtaugakerfi sem bendir til heila- og mænusiggs eða staðbundin mergslíðurssvipting eins og sjóntaugarþroti og þverrofsmænubólga (transverse myelitis) (sjá kafla 4.4), mergslíðurssvipting í úttaugakerfi, þ.m.t. Guillain-Barré heilkenni, krónískur bólgumyndandi fjöltaugakvilli með mergslíðurssviptingu
English: Re-introduction of treatment with LIFMIOR after discontinuation of up to 24 months resulted in the same magnitudes of responses as patients who received LIFMIOR without interruption of therapy based on results of open-label studies.
Icelandic: Samkvæmt niðurstöðum úr opinni rannsókn, var sama svörun við LIFMIOR hjá sjúklingum sem hófu meðferð að nýju eftir allt að 24 mánaða hlé og hjá sjúklingum sem höfðu fengið samfellda meðferð með LIFMIOR.
English: LIFMIOR 25 mg solution for injection in pre-filled syringe.
Icelandic: LIFMIOR 25 mg stungulyf, lausn í áfylltri sprautu.
English: (symptoms may include persistent rash, fever, joint pain, and tiredness); skin rash, which may lead to severe blistering and peeling of the skin; lichenoid reactions (itchy reddish-purple skin rash and/or threadlike white-grey lines on mucous membranes); inflammation of the liver caused by the body's own immune system (autoimmune hepatitis; in patients also receiving methotrexate treatment, the frequency is uncommon); immune disorder that can affect the lungs, skin and lymph nodes (sarcoidosis); inflammation or scarring of the lungs (in patients also receiving methotrexate treatment, the frequency of inflammation or scarring of the lungs is uncommon).
Icelandic: (hækkaðir rauðir eða fölir blettir á húð sem oft valda kláða); augnbólga, psoriasis (nýtt eða versnandi); bólga í æðum sem hefur áhrif á mörg líffæri; hækkuð lifrarensím (hjá sjúklingum sem fá einnig meðferð með metótrexati er tíðni hækkaðra lifrarensíma algeng).
English: The needle cover should not be removed while allowing the prefilled pen to reach room temperature.
Icelandic: Ekki á að fjarlægja nálarhulstrið á meðan áfyllta sprautan nær stofuhita.
English: CNS demyelinating events suggestive of multiple sclerosis or localised demyelinating conditions, such as optic neuritis and transverse myelitis (see section 4.4), peripheral demyelinating events, including GuillainBarré syndrome, chronic inflammatory
Icelandic: Mergslíðurssviptin g í miðtaugakerfi sem bendir til heila- og mænusiggs eða staðbundin mergslíðurssviptin g eins og sjóntaugarþroti og þverrofsmænubólg a (transverse myelitis) (sjá kafla 4.4), mergslíðurssviptin g í úttaugakerfi, þ.m.t. GuillainBarré heilkenni,
English: CARTON TEXT (For paediatric use) - EU/1/16/1165/001
Icelandic: TEXTI Á ÖSKJU (Til notkunar fyrir börn) - EU/1/16/1165/001
English: For children, remove only the portion of liquid as directed by your child's doctor.
Icelandic: Ef um börn er að ræða, skaltu draga út það magn sem læknir hefur fyrirskrifað.
English: Etanercept is a competitive inhibitor of TNF-binding to its cell surface receptors and thereby inhibits the biological activity of TNF.
Icelandic: Etanercept keppir við TNF um bindingu við sinn eigin frumuyfirborðsviðtaka og blokkar við það líffræðilega virkni TNF.
English: Axial spondyloarthritis
Icelandic: Millivefslungnasjúkdómur
English: Significant advantages for LIFMIOR in combination with methotrexate compared with LIFMIOR monotherapy and methotrexate monotherapy were also observed after 24 months.
Icelandic: Eftir 24 mánuði kom einnig í ljós marktækur yfirburður LIFMIOR í samsettri meðferð með metótrexati, samanborið við einlyfjameðferð með LIFMIOR eða metótrexati.
English: Cases of active tuberculosis including miliary tuberculosis and tuberculosis with extra-pulmonary location have been reported in patients treated with LIFMIOR.
Icelandic: Greint hefur verið frá tilfellum virkra berkla, þar með talið dreifberklar og berklar utan lungna hjá sjúklingum sem fengu meðferð með LIFMIOR.
English: a. Introduction b. Setting up for an injection c.
Icelandic: Undirbúningur fyrir inndælingu c.
English: Clinical improvement, including onset of action within 2 weeks with LIFMIOR 25 mg, was similar to that seen in the previous trials and was maintained for up to 24 months.
Icelandic: Bati var í samræmi við niðurstöður úr fyrri rannsóknum og hélst í allt að 24 mánuði og LIFMIOR 25 mg byrjaði að verka innan tveggja vikna.
English: Serious allergic reactions (including severe localised swelling of the skin and wheezing); lymphoma (a type of blood cancer); leukaemia (cancer affecting the blood and bone marrow); melanoma (a type of skin cancer); combined low platelet, red, and white blood cell count; nervous system disorders (with severe muscle weakness and signs and symptoms similar to those of multiple sclerosis or inflammation of the nerves of the eyes or spinal cord); tuberculosis; new onset congestive heart failure; seizures; lupus or lupus-like syndrome
Icelandic: Alvarlegar sýkingar (þar með talin lungnabólga, djúpar húðsýkingar, liðsýkingar, blóðsýkingar og sýkingar á mismunandi stöðum); versnun hjartabilunar; fækkun rauðra blóðkorna, fækkun hvítra blóðkorna, fækkun daufkyrninga (ein tegund hvítra blóðkorna); fækkun blóðflagna; krabbamein í húð (sem ekki er sortuæxli); staðbundin húðbólga (ofsabjúgur); ofsakláði
English: Renal impairment
Icelandic: Öskjur innihalda
English: Your doctor will determine if preventive treatment for chickenpox is appropriate.
Icelandic: Læknirinn mun ákveða hvort beita skuli viðeigandi forvarnarmeðferð við hlaupabólu.
English: Do not shake the pen.
Icelandic: Ekki nudda stungustaðinn.
English: LIFMIOR 25 mg solution for injection in pre-filled syringe etanercept
Icelandic: LIFMIOR 25 mg stungulyf, lausn í áfylltri sprautu etanercept
English: Two juvenile idiopathic arthritis patients developed varicella infection and signs and symptoms of aseptic meningitis, which resolved without sequelae.
Icelandic: Tveir sjúklingar með sjálfvakta barnaliðagigt fengu hlaupabólu og merki um heilahimnubólgu án sýkingar, sem gekk til baka án frekari afleiðinga.
English: • If the child has psoriasis, you should try not to inject directly into any raised, thick, red, or scaly skin patches (“psoriasis skin lesions”).
Icelandic: Ef barnið er með psoriasis, skaltu forðast að stinga beint í upphækkaða, þykka, rauða eða flagnandi húðfleti („psoriasis útbrot“).
English: Waiting until the solution reaches room temperature may make the injection more comfortable for you.
Icelandic: Inndælingin verður þægilegri fyrir þig ef þú bíður þar til lausnin nær stofuhita.
English: Patients were observed off treatment for the occurrence of rebound (PASI ≥150% of baseline) and for the time to relapse (defined as a loss of at least half of the improvement achieved between baseline and week 24).
Icelandic: Fylgst var með sjúklingum eftir að meðferð var hætt, með tilliti til mikillar versnunar (PASI 150% frá grunnlínu) og tíma fram að bakslagi (skilgreint sem minnkun um a.m.k.
English: In this situation, the benefit/risk balance of LIFMIOR therapy should be very carefully considered.
Icelandic: Meta skal vandlega ávinning umfram áhættu við LIFMIOR meðferð, í þessum tilfellum.
English: 2.6 mg/l, Cmin of 1.2 mg/l vs. 1.4 mg/l, and partial AUC of 297 mgh/l vs. 316 mgh/l for 50 mg LIFMIOR once weekly (n=21) vs. 25 mg LIFMIOR twice weekly (n=16), respectively.
Icelandic: klst./l og hjá iktsýkisjúklingum á meðferð með 25 mg LIFMIOR tvisvar í viku (n=16) var Cmax 2,6 mg/l, Cmin 1,4 mg/l og AUC var 316 mg•klst./l. Í opinni, stakskammta víxlunarrannsókn (crossover study) á heilbrigðum sjálfboðaliðum í tveimur meðhöndlunarhópum kom fram að etanercept 50 mg/ml inndæling í eitt skipti jafngilti tveimur samtímis inndælingum með 25 mg/ml.
English: Pregnancy
Icelandic: Bólusetning
English: Rheumatoid arthritis
Icelandic: Röntgenbreytingar:
English: There have been postmarketing reports of pancytopenia and aplastic anaemia, some of which had fatal outcomes (see section 4.4).
Icelandic: Blóðfrumnafæð og vanmyndunarblóðleysi (aplastic anaemia) Eftir markaðssetningu hafa verið skráð tilfelli af blóðfrumnafæð og vanmyndunarblóðleysi sem sum hafa leitt til dauða (sjá kafla 4.4)
English: 25 mg LIFMIOR administered twice weekly is the recommended dose.
Icelandic: Ráðlagður skammtur er 25 mg LIFMIOR gefið tvisvar í viku.
English: demyelinating polyneuropathy, demyelinating polyneuropathy, and multifocal motor neuropathy (see section 4.4), seizure
Icelandic: , fjöltaugakvilli með mergslíðurssviptingu og fjölhreiðra hreyfitaugakvilli (sjá kafla 4.4), flog
English: 50 mg solution for injection in pre-filled syringe
Icelandic: 50 mg stungulyf, lausn í áfylltri sprautu
English: Diagram 1 The MYCLIC pre-filled pen
Icelandic: Notaða MYCLIC lyfjapennanum fargað
English: Each pre-filled syringe of LIFMIOR contains 25 mg etanercept.
Icelandic: Hver áfyllt sprauta af LIFMIOR inniheldur 25 mg etanercept.
English: Congestive heart failure (Cardiac failure congestive) Physicians should use caution when using LIFMIOR in patients who have congestive heart failure (CHF).
Icelandic: Læknum ber að gæta varúðar við notkun LIFMIOR hjá sjúklingum sem hafa hjartabilun.
English: In patients who develop HBV infection, LIFMIOR should be stopped and effective anti-viral therapy with appropriate supportive treatment should be initiated.
Icelandic: Hætta skal meðferð með LIFMIOR hjá sjúklingum sem þróa lifrarbólguveiru B sýkingu og hefja viðeigandi veirulyfjameðferð ásamt stuðningsmeðferð eftir því sem við á.
English: The dosage of LIFMIOR is based on body weight for paediatric patients.
Icelandic: LIFMIOR skammtar fyrir börn eru byggðir á líkamsþyngd.
English: Each pre-filled pen of LIFMIOR contains 50 mg etanercept.
Icelandic: Hver áfyllt sprauta af LIFMIOR inniheldur 50 mg etanercept.
English: Interstitial lung disease
Icelandic: Svörun hjá hryggiktarsjúklingum
English: Elevated liver enzymes*
Icelandic: Hækkuð lifrarensím* Sjálfsnæmislifrarb ólga*
English: Adult patients with non-radiographic axial spondyloarthritis
Icelandic: Fullorðnir sjúklingar með áslægan hryggbólgusjúkdóm án vísbendinga um hryggikt samkvæmt röntgengreiningu
English: LIFMIOR 50 mg solution for injection in pre-filled syringe.
Icelandic: LIFMIOR 50 mg stungulyf, lausn í áfylltri sprautu.
English: Summary of the safety profile
Icelandic: Mikilvægustu niðurstöður úr rannsóknum
English: 2.3†,φ
Icelandic: 2, 3 og 4
English: 25 mg solution for injection in pre-filled syringe
Icelandic: 25 mg stungulyf, lausn í áfylltri sprautu
English: LIFMIOR 50 mg solution for injection in pre-filled syringe etanercept
Icelandic: LIFMIOR 50 mg stungulyf, lausn í áfylltri sprautu etanercept
English: b. Setting up for an injection
Icelandic: Undirbúningur fyrir inndælingu
English: Solution for injection in pre-filled syringe
Icelandic: Lyf til ónæmisbælingar.
English: In a controlled clinical trial of two years duration in rheumatoid arthritis patients, the combination of LIFMIOR and methotrexate did not result in unexpected safety findings, and the safety profile of LIFMIOR when given in combination with methotrexate was similar to the profiles reported in studies of LIFMIOR and methotrexate alone.
Icelandic: MTX LIFMIOR 25 mg kom einnig í ljós marktækur yfirburður LIFMIOR í samsettri meðferð með metótrexati, samanborið við einlyfjameðferð með LIFMIOR eða metótrexati.
English: Compared to placebo, treatment with LIFMIOR resulted in statistically significant improvement in the ASAS 40, ASAS 20 and ASAS 5/6.
Icelandic: LIFMIOR borið saman við lyfleysu á öllum tímapunktum fyrir ACR 20 og ACR 50 svörun).
English: d. Adding solvent
Icelandic: B. FYLGISEÐILL
English: Neurological disorders
Icelandic: Ónæmiskerfi
English: Each vial of LIFMIOR contains 25 mg etanercept.
Icelandic: Hvert hettuglas af LIFMIOR inniheldur 25 mg af etanercept.
English: ASAS 50 2 weeks
Icelandic: 50 mg 2x viku
English: Treatment with LIFMIOR may result in reactivation of hepatitis B in patients who have previously been infected with the hepatitis B virus.
Icelandic: B sýkingu er mælt með að samráð sé haft við lækni með sérþekkingu á meðferð lifrarbólgu B. Gæta skal varúðar þegar LIFMIOR er gefið sjúklingum sem hafa áður sýkst af lifrarbólguveiru B. Fylgjast skal með þessum sjúklingum hvað varðar einkenni virkrar lifrarbólguveiru
English: Do NOT shake the vial.
Icelandic: EKKI hrista hettuglasið.
English: • Common (may affect up to 1 in 10 people):
Icelandic: Algengar (geta komið fyrir hjá allt að 1 af hverjum 10 einstaklingum):
English: Psoriatic arthritis, ankylosing spondylitis and non-radiographic axial spondyloarthritis
Icelandic: Sóragigt, hryggikt og áslægur hryggbólgusjúkdómur án vísbendinga um hryggikt samkvæmt röntgengreiningu
English: Cutaneous lupus erythematosus, subacute cutaneous lupus erythematosus, lupus-like syndrome
Icelandic: Iktsýki, sóragigt og áslægur hryggbólgusjúkdómur, þ.m.t. hryggikt
English: LIFMIOR 10 mg powder and solvent for solution for injection for paediatric use.
Icelandic: LIFMIOR 10 mg stungulyfsstofn og leysir, lausn til notkunar fyrir börn.
English: • Wegener's granulomatosis: LIFMIOR is not recommended for the treatment of Wegener's granulomatosis, a rare inflammatory disease.
Icelandic: LIFMIOR er ekki ætlað til notkunar á Wegener hnúðabólgum, sjaldgæfum bólgusjúkdómi.
English: A bandage is optional.
Icelandic: Áfyllta sprautan er einnota.
English: LIFMIOR 10 mg powder and solvent for solution for injection for paediatric use Etanercept
Icelandic: LIFMIOR 10 mg stungulyfsstofn og leysir, lausn til notkunar fyrir börn etanercept
English: A dose response was seen; results with 10 mg were intermediate between placebo and 25 mg. LIFMIOR was significantly better than placebo in all components of the ACR criteria, as well as other measures of rheumatoid arthritis disease activity not included in the ACR response criteria, such as morning stiffness.
Icelandic: LIFMIOR var verulega betra en lyfleysa í öllum þáttum sem ACR mælikvarðinn tekur til, sem og öðrum þáttum iktsýki sem ACR tekur ekki tillit til, svo sem morgunstirðleika.
English: If you are concerned with the appearance of the solution, then contact your pharmacist for assistance.
Icelandic: Leitaðu til lyfjafræðings ef þú hefur áhyggjur af útliti lausnarinnar.
English: With twice-weekly doses, it is anticipated that steady-state concentrations are approximately twice as high as those observed after single doses.
Icelandic: Gert er ráð fyrir að þéttni í blóði við jafnvægi eftir gjöf lyfsins tvisvar í viku sé um það bil tvisvar sinnum hærri en eftir staka skammta.
English: Combination therapy
Icelandic: Samsett meðferð
English: Trometamol
Icelandic: LOTUNÚMER
English: Each pack contains 2, 4 or 12 pre-filled syringes and 2, 4 or 12 alcohol swabs.
Icelandic: Hver askja inniheldur 2, 4, eða 12 áfyllta lyfjapenna með LIFMIOR og 2, 4 eða 12 sprittklúta.
English: Undesirable effects in paediatric patients with juvenile idiopathic arthritis
Icelandic: Klínísk svörun hjá sjúklingum með nr-AxSpa sem fengu
English: UNIQUE IDENTIFIER-2D BARCODE 2D barcode carrying the unique identifier included.
Icelandic: Á pakkningunni er tvívítt strikamerki með einkvæmu auðkenni.
English: When the cleaned area of skin has dried, pinch and hold it firmly with one hand.
Icelandic: Þegar sótthreinsað húðsvæðið hefur þornað notaðu aðra höndina til að klípa varlega saman húðsvæðið og haltu fast á sprautunni eins og blýanti.
English: Injection site reactions
Icelandic: Ofnæmisviðbrögð:
English: Autoantibodies
Icelandic: Myndun sjálfsmótefnis
English: Adult patients with ankylosing spondylitis
Icelandic: Fullorðnir sjúklingar með sóragigt
English: Powder and solvent for solution for injection (powder for injection).
Icelandic: Stungulyfsstofn og leysir, lausn (stungulyfsstofn).
English: The recommended dose of LIFMIOR is 25 mg administered twice weekly or 50 mg administered once weekly.
Icelandic: Ráðlagður skammtur af LIFMIOR er 25 mg tvisvar í viku eða 50 mg einu sinni í viku.
English: Compared to placebo, treatment with LIFMIOR resulted in significant improvements in the ASAS 20, ASAS 50 and ASAS 70 as early as 2 weeks after the initiation of therapy.
Icelandic: ASAS 20, ASAS 50 og ASAS 70 strax eftir 2 vikna meðferð.
English: Green activation button
Icelandic: Áhrif á miðtaugakerfi
English: Central and peripheral demyelinating events have been seen rarely and very rarely, respectively, with LIFMIOR use.
Icelandic: Mjög sjaldan hafa sést tilvik mergslíðurssviptingar í miðtaugakerfi og örsjaldan í úttaugakerfi við LIFMIOR notkun.
English: Paediatric plaque psoriasis (age 6 years and above) The recommended dose is 0.8 mg/kg (up to a maximum of 50 mg per dose) once weekly for up to 24 weeks.
Icelandic: Börn með skellupsoriasis (á aldrinum 4 -17 ára) fengu 0,8 mg/kg (að hámarki 50 mg á viku) af etanercept einu sinni í viku í allt að 48 vikur.
English: Cartons contain 2, 4 or 12 pre-filled syringes of LIFMIOR with 2, 4 or 12 alcohol swabs.
Icelandic: Hver askja inniheldur 2, 4 eða 12 áfylltar sprautur með LIFMIOR og 2, 4 eða 12 sprittklúta.
English: Hepatic impairment
Icelandic: Methotrexate Enbrel
English: Serum concentration profiles were similar to those seen in adult rheumatoid arthritis patients.
Icelandic: Þessi meðalþéttni var svipuð þeirri sem sást hjá fullorðnum sjúklingum með skellupsoriasis sem fengu
English: Comprehensive instructions for administration are given in the package leaflet, section 7, "Instructions for preparation and giving an injection of LIFMIOR."
Icelandic: Ítarlegar leiðbeiningar um lyfjagjöf LIFMIOR eru gefnar í fylgiseðli, kafla 7, „Leiðbeiningar fyrir undirbúning og gjöf á LIFMIOR stungulyfi“.
English: LIFMIOR 25 mg powder and solvent for solution for injection Etanercept
Icelandic: LIFMIOR 25 mg stungulyfsstofn og leysir, lausn Etanercept
English: LIFMIOR 25 mg powder and solvent for solution for injection etanercept
Icelandic: LIFMIOR 25 mg stungulyfsstofn og leysir, lausn etanercept
English: The study evaluated 234 adult patients with active rheumatoid arthritis who had failed therapy with at least one but no more than four disease-modifying antirheumatic drugs (DMARDs).
Icelandic: Lagt var mat á 234 fullorðna iktsýkisjúklinga sem höfðu ekki svarað meðferð við a.m.k.
English: Subcutaneous use
Icelandic: + Methotrexate
English: 50 mg BIW
Icelandic: 50 mg 1x viku
English: Pairwise comparison p-values: † = p < 0.05 for comparisons of LIFMIOR + methotrexate vs methotrexate and φ = p < 0.05 for comparisons of LIFMIOR + methotrexate vs LIFMIOR
Icelandic: Pör borin saman, p-gildi: † = p < 0,05 þegar LIFMIOR + metótrexat er borið saman við metótrexat  = p < 0,05 þegar LIFMIOR + metótrexat er borið saman við LIFMIOR
English: • Keep this leaflet.
Icelandic: † Vinsamlegast sjáið undirkaflann
English: The primary measure of efficacy (ASAS 40) was a 40% improvement in at least three of the four ASAS domains and absence of deterioration in the remaining domain.
Icelandic: þremur af hinum fjórum flokkum ASAS og að ekki hafði orðið afturför í hinum flokkunum.
English: Step 3: Injecting the LIFMIOR solution
Icelandic: á LIFMIOR lausninni skref:
English: Infection (including upper respiratory tract infection, bronchitis, cystitis, skin infection)*
Icelandic: Sýking (þ.m.t sýking í efri öndunarvegi, berkjubólga, blöðrubólga, húðsýking)*
English: Τηλ.
Icelandic: Ltd.
English: 4 vials of powder
Icelandic: Lifur og gall
English: Cardiac disorders
Icelandic: Hjartabilun:
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 1 ml water for injections
Icelandic: 1 ml af vatni fyrir stungulyf
English: 1.0 ml (50 mg/ml) 12 (3 x 4) pre-filled pens (multipack)
Icelandic: 12 (3 x 4) áfylltir lyfjapennar (fjölpakkning)
English: Immediate Packaging
Icelandic: Innihald (þéttni) Pakkningastærð
English: Pack size bottle (HDPE)
Icelandic: Pakkningastærð glas (HDPE)
English: Immediate Packaging
Icelandic: Innri umbúðir
English: What X is and what it is used for
Icelandic: Upplýsingar um X og við hverju það er notað
English: The study was terminated early because of an increased risk of adverse outcomes.
Icelandic: Rannsóknin var stöðvuð snemma vegna aukinnar hættu á aukaverkunum.
English: This combination apparently increases the risk for adverse events and is therefore not recommended.
Icelandic: Þessi samsetning virðist auka hættu á aukaverkunum og því er ekki mælt með henni.
English: Section 1.
Icelandic: Kafli 1.
English: Other medicines and X
Icelandic: Notkun annarra lyfja samhliða X
English: “Heart failure
Icelandic: "Hjartabilun
English: “Your doctor may need to change your dose and/or to take other precautions:
Icelandic: „Vera má að læknirinn þurfi að breyta skömmtum þeirra lyfja og/eða gera aðrar varúðarráðstafanir:
English: “Dual blockade of the renin-angiotensin-aldosterone system (RAAS)
Icelandic: „Tvöföld hömlun á renín-angíótensín-aldósterónkerfinu
English: PL Section 2.
Icelandic: PL kafli 2.
English: Caution should be observed when initiating therapy in patients with heart failure.
Icelandic: Gæta skal varúðar í upphafi meðferðar hjá sjúklingum með hjartabilun.
English: These medicines are for the treatment of heart failure (see “Other medicines and X”).”
Icelandic: Þessi lyf eru notuð til meðhöndlunar á hjartabilun (sjá „Notkun annarra lyfja samhliða X“).“
English: The following wording should be added to this section (for telmisartan-containing products that already have an extensive wording on ONTARGET in section 5.1, the following wording should be added in addition to the existing text, which should be maintained):
Icelandic: Eftirfarandi orðalagi skal bætt við kaflann (fyrir lyf sem innihalda telmisartan þar sem nú þegar er ýtarlegt orðalag um ONTARGET í kafla 5.1, skal bæta eftirfarandi orðalagi við núverandi texta sem á að halda sér):
English: Talk to your doctor <or> <pharmacist> <or nurse> before <taking> <using> X
Icelandic: Leitið ráða hjá lækninum <eða> <,> <lyfjafræðingi> <eða hjúkrunarfræðingnum> áður en X er notað.
English: For products containing the angiotensin-converting enzyme inhibitors (ACE-inhibitors) benazepril, captopril, cilazapril, delapril, enalapril, fosinopril, imidapril, lisinopril, moexipril, perindopril, quinapril, ramipril, spirapril, trandolapril and zofenopril, the existing product information shall be amended (insertion, replacement or deletion of the text as appropriate) to reflect the agreed wording as provided below
Icelandic: Fyrir lyf sem innihalda ACE-hemla, benazepril, captopril, cilazapril, delapril, enalapril, fosinopril, imidapril, lisinopril, moexipril, perindopril, quinapril, ramipril, spirapril, trandolapril og zofenopril, skal breyta núverandi samantekt á eiginleikum lyfs og fylgiseðli (bæta við, skipta út eða eyða texta eftir því sem við á) til að endurspegla samþykkt orðalag hér að neðan
English: Section 2.
Icelandic: Kafli 2.
English: Section 4.5 - Interaction with other medicinal products and other forms of interaction
Icelandic: Kafli 4.5 - Milliverkanir við önnur lyf og aðrar milliverkanir
English: Do not <take> <use> X <:>
Icelandic: „Ekki má nota X<:>““