FrancophonIA/ELRC3.0 huggingface dataset:
English: Ascites, pancreatitis, swollen tongue, dysphagia
Icelandic: Skinuholsvökvi, brisbólga, bólgin tunga, kyngingartregða
English: hard capsules regularly at the same time each day.
Icelandic: Mikilvægt er að taka Pregabalin Zentiva k.s. reglulega og alltaf á sama tíma sólarhringsins.
English: Other medicines and Pregabalin Zentiva k.s.
Icelandic: Notkun annarra lyfja samhliða Pregabalin Zentiva k.s.
English: The N- methylated derivative of pregabalin, the major metabolite of pregabalin found in urine, accounted for 0.9% of the dose.
Icelandic: 0,9% af skammtinum reyndist vera N-metýleruð afleiða pregabalíns sem er aðalumbrotsefni pregabalíns sem finnst í þvagi.
English: In conventional safety pharmacology studies in animals, pregabalin was well-tolerated at clinically relevant doses.
Icelandic: öryggi hjá dýrum þoldist pregabalín vel.
English: 75 mg, 150 mg, 225 mg and 300 mg is available in pack of 14, 56, 98 and 100 hard capsules.
Icelandic: Pregabalin Zentiva k.s. 75 mg, 150 mg, 225 mg og 300 mg er í pakkningum með 14, 56, 98 og 100 hörðum hylkjum.
English: Interactions and the elderly
Icelandic: Milliverkanir og aldraðir
English: Syncope, stupor, myoclonus, loss of consciousness, psychomotor hyperactivity, dyskinesia, dizziness postural, intention tremor, nystagmus, cognitive disorder, mental impairment, speech disorder, hyporeflexia, hyperaesthesia, burning sensation, ageusia, malaise
Icelandic: Yfirlið, hugstol, vöðvarykkjakrampi, meðvitundarleysi, skynhreyfiofvirkni, hreyfingartregða, réttstöðusundl, athafnaskjálfti (intention tremor), augntin, skilvitleg truflun, andleg skerðing, talörðugleikar, vantaugaviðbrögð, ofurnæmt snertiskyn, sviðatilfinning, bragðleysi, lasleiki
English: Encephalopathy
Icelandic: Lifrarbólga
English: Black iron oxide (E172) Titanium dioxide (E171) Gelatin
Icelandic: - Svart járnoxíð (E172) - Títantvíoxíð (E171) - Gelatína
English: Black iron oxide (E172) Propylene glycol
Icelandic: - Svart járnoxíð (E172) - Pólýetýlen glýkól
English: Discontinuation of pregabalin
Icelandic: Pregabalín
English: Strong ammonia solution Potassium hydroxide
Icelandic: - Sterk ammóníaklausn
English: contains lactose monohydrate If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
Icelandic: Ef óþol fyrir sykrum hefur verið staðfest skal hafa samband við lækni áður en lyfið er tekið inn.
English: Pain sensations may be described as hot, burning, throbbing, shooting, stabbing, sharp, cramping, aching, tingling, numbness, pins and needles.
Icelandic: Verkjatilfinningunni hefur verið lýst sem: hita, sviða, slætti, skoti, sting, nístandi, krampa, verk, dofa, tilfinningaleysi og náladofa.
English: Hallucination, panic attack, restlessness, agitation, depression, depressed mood, elevated mood, aggression, mood swings, depersonalisation, word finding difficulty, abnormal dreams, libido increased, anorgasmia, apathy
Icelandic: Ofskynjanir, kvíðakast, eirðarleysi, uppnám, þunglyndi, depurð, ofsakæti, árásarhneigð, skapsveiflur, sjálfhvarf (depersonalisation), málstol, óvenjulegir draumar, aukin kynhvöt, kynferðisleg fullnæging næst ekki), sinnuleysi
English: In controlled trials, a higher proportion of patients treated with pregabalin reported blurred vision than did patients treated with placebo which resolved in a majority of cases with continued dosing.
Icelandic: Í samanburðarrannsóknum greindi hærra hlutfall sjúklinga sem fékk meðferð með pregabalíni frá þokusýn sem í flestum tilvikum gekk til baka þegar meðferð var haldið áfram miðað við sjúklinga sem fengu lyfleysu.
English: Dizziness, somnolence, headache
Icelandic: Nýrnabilun, þvagþurrð, þvagteppa
English: Excipient with known effect: Each hard capsule also contains 22.5 mg lactose monohydrate.
Icelandic: Hvert hart hylki inniheldur einnig 22,5 mg laktósaeinhýdrat.
English: Each hard capsule contains 75 mg of pregabalin.
Icelandic: Hvert hart hylki inniheldur 75 mg pregabalín.
English: Ophthalmologic testing (including visual acuity testing, formal visual field testing and dilated funduscopic examination) was conducted in over 3600 patients within controlled clinical trials.
Icelandic: Í klínískum samanburðarrannsóknum var gert sjónpróf á yfir 3.600 sjúklingum (þ.m.t. mæld sjónskerpa, sjónsvið mælt og augnspeglun með víkkuðu sjáaldri).
English: for you to help treat your epilepsy when your current treatment is not controlling your condition.
Icelandic: Zentiva k.s. þegar núverandi meðferð dugar ekki lengur til þess að ná tökum á flogaveikinni.
English: is used to treat long lasting pain caused by damage to the nerves.
Icelandic: Pregabalin Zentiva k.s. er notað til meðferðar á langvarandi verkjum af völdum taugaskemmda.
English: than you should.
Icelandic: Á ekki við.
English: Overall, the safety and efficacy profiles for BID and TID dosing regimens were similar.
Icelandic: Öryggi og verkun eftir skömmtun tvisvar og þrisvar á sólarhring reyndist sambærileg.
English: Excipient with known effect: Each hard capsule also contains 7.5 mg lactose monohydrate.
Icelandic: Hvert hart hylki inniheldur einnig 7,5 mg laktósaeinhýdrat.
English: Each hard capsule contains 200 mg of pregabalin.
Icelandic: Hvert hart hylki inniheldur 200 mg pregabalín.
English: The 25 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg, 300 mg capsules also contain polyethylene glycol.
Icelandic: 25 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg og 300 mg hörð hylki innihalda einnig pólýetýlen glýkól.
English: If you stop taking Pregabalin Zentiva k.s.
Icelandic: Ef hætt er að nota Pregabalin Zentiva k.s.
English: Vision loss, keratitis, oscillopsia, altered visual depth perception, mydriasis, strabismus, visual brightness
Icelandic: Sjónmissir, glærubólga, sveiflusýni, breyting á dýptarsjónskyni, ljósopsstæring, rangeygi, ofbirta
English: How to store Pregabalin Zentiva k.s.
Icelandic: Hvernig geyma á Pregabalin Zentiva k.s.
English: Each hard capsule contains 300 mg of pregabalin.
Icelandic: Hvert hart hylki inniheldur 300 mg pregabalín.
English: Red cap and light grey body; approx. 21,7 mm in length, hard gelatin capsule with imprinting “300”, containing almost white powder.
Icelandic: Rauð hetta og ljósgrár bolur; hart gelatínuhylki u.þ.b. 21,7 mm að lengd með áletruninni „300“, inniheldur svo til hvítt duft.
English: Excipient with known effect: Each hard capsule also contains 20 mg lactose monohydrate.
Icelandic: Hvert hart hylki inniheldur einnig 20 mg laktósaeinhýdrat.
English: • There have been reports of reduction in brain function (encephalopathy) in some patients taking pregabalin when they have other conditions.
Icelandic: Greint hefur verið frá minnkaðri heilastarfsemi (heilakvilla) hjá nokkrum sjúklingum sem eru með aðra sjúkdóma og taka pregabalín.
English: Each hard capsule contains 100 mg of pregabalin.
Icelandic: Hvert hart hylki inniheldur 100 mg pregabalín.
English: Each hard capsule contains 50 mg of pregabalin.
Icelandic: Hvert hart hylki inniheldur 50 mg pregabalín.
English: These include, trouble sleeping, headache, nausea, feeling anxious, diarrhoea, flulike symptoms, convulsions, nervousness, depression, pain, sweating, and dizziness.
Icelandic: Þær eru m.a. svefnerfiðleikar, höfuðverkur, ógleði, kvíðatilfinning, niðurgangur, flensulík einkenni, krampar, taugaóstyrkur, þunglyndi, verkir, sviti og sundl.
English: Red cap and red body; approx. 15,9 mm in length, hard gelatin capsule with imprinting “100”, containing almost white powder.
Icelandic: Rauð hetta og rauður bolur, hart gelatínuhylki u.þ.b. 15,9 mm að lengd með áletruninni „100“, inniheldur svo til hvítt duft.
English: Excipient with known effect: Each hard capsule also contains 30 mg lactose monohydrate.
Icelandic: Hvert hart hylki inniheldur einnig 30 mg laktósaeinhýdrat.
English: Red cap and light grey body; approx. 14,3 mm in length, hard gelatin capsule with imprinting “75”, containing almost white powder.
Icelandic: Rauð hetta og ljósgrár bolur, hart gelatínuhylki u.þ.b. 14.3 mm að lengd með áletruninni „75“, inniheldur svo til hvítt duft.
English: STATEMENT OF ACTIVE SUBSTANCE Each hard capsule contains 25 mg of pregabalin.
Icelandic: VIRK(T) EFNI Hvert hart hylki inniheldur 25 mg pregabalín.
English: Hypotension, hypertension, hot flushes, flushing, peripheral coldness Respiratory, thoracic and mediastinal disorders Uncommon
Icelandic: Lágþrýstingur, háþrýstingur, hitasteypa, roði, útlimakuldi Öndunarfæri, brjósthol og miðmæti Sjaldgæfar
English: Ataxia, coordination abnormal, tremor, dysarthria, amnesia, memory impairment, disturbance in attention, paraesthesia, hypoaesthesia, sedation, balance disorder, lethargy
Icelandic: Ósamhæfing hreyfinga, óeðlileg samhæfing, skjálfti, tormæli, minnisleysi, minnisskerðing, einbeitingarskortur, náladofi, snertiskynsminnkun, slæving, jafnvægistruflun, drungi
English: Each hard capsule contains 150 mg of pregabalin.
Icelandic: Hvert hart hylki inniheldur 150 mg pregabalín.
English: The following events have been mentioned: insomnia, headache, nausea, anxiety, diarrhoea, flu syndrome, nervousness, depression, pain, convulsion, hyperhidrosis and dizziness, suggestive of physical dependence.
Icelandic: Greint hefur verið frá eftirfarandi einkennum: svefnleysi, höfuðverk, ógleði, kvíða, niðurgangi, flensulíkum einkennum, taugaveiklun, þunglyndi, verkjum, krömpum (convulsion), ofsvitnun og sundli sem bendir til ávanabindingar.
English: contains
Icelandic: Meðganga
English: The non-genotoxic mechanism of pregabalin-induced tumour formation in mice involves platelet changes and associated endothelial cell proliferation.
Icelandic: Þessi pregabalínháða æxlismyndun hjá músum hefur í för með sér breytingar á blóðflögum samfara fjölgun æðaþelsfrumna en hefur ekki áhrif á erfðaefni.
English: Flesh opaque cap and light grey body; approx. 19,4 mm in length, hard gelatin capsule with imprinting “225”, containing almost white powder.
Icelandic: Húðlit ógegnsæ hetta og ljósgrár bolur; hart gelatínuhylki u.þ.b. 19,4 mm að lengd með áletruninni „225“, inniheldur svo til hvítt duft.
English: When taken with certain other medicines, pregabalin may potentiate the side effects seen with these medicines, including respiratory failure and coma.
Icelandic: Þegar pregabalín er notað samtímis ákveðnum lyfjum getur pregabalín aukið aukaverkanir þeirra þ.m.t.
English: Each hard capsule contains 25 mg of pregabalin.
Icelandic: Hvert hart hylki inniheldur 25 mg pregabalín.
English: 200 mg hard capsules Pregabalin Zentiva k.s.
Icelandic: Pregabalin Zentiva k.s. 200 mg hörð hylki
English: is indicated for the treatment of generalised anxiety disorder (GAD) in adults.
Icelandic: Pregabalin Zentiva k.s. er notað til meðferðar á almennri kvíðaröskun hjá fullorðnum.
English: Peripheral vision loss, visual disturbance, eye swelling, visual field defect, visual acuity reduced, eye pain, asthenopia, photopsia, dry eye, lacrimation increased, eye irritation
Icelandic: Minnkun á jaðarsjón, sjóntruflun, augnbólga, breyting á sjónsviði, minnkuð sjónskerpa, augnverkur, augnþreyta, glampar fyrir augum, augnþurrkur, aukin táraseyting, erting í augum
English: STATEMENT OF ACTIVE SUBSTANCE Each hard capsule contains 225 mg of pregabalin.
Icelandic: VIRK(T) EFNI Hvert hart hylki inniheldur 225 mg pregabalín
English: Light grey cap and light grey body; approx. 15,9 mm in length, hard gelatin capsule with imprinting “25”, containing almost white powder.
Icelandic: Ljósgrá hetta og ljósgrár bolur, hart gelatínuhylki u.þ.b. 15,9 mm að lengd með áletruninni „25“, inniheldur svo til hvítt duft.
English: Infections and infestations Common
Icelandic: LYFJAFORM OG INNIHALD
English: Light grey cap and light grey body; approx. 18,0 mm in length, hard gelatin capsule with imprinting “150”, containing almost white powder.
Icelandic: Ljósgrá hetta og ljósgrár bolur, hart gelatínuhylki u.þ.b. 18,0 mm að lengd með áletruninni „150“, inniheldur svo til hvítt duft.
English: Pregabalin should be discontinued immediately if symptoms of angioedema, such as facial, perioral, or upper airway swelling occur.
Icelandic: Hætta skal strax meðferð með pregabalíni ef einkenni ofnæmisbjúgs t.d. bólga í andliti, umhverfis munn eða í efri hluta öndunarvegar koma fram.
English: How to take Pregabalin Zentiva k.s.
Icelandic: Hvernig nota á Pregabalin Zentiva k.s.
English: • Muscle twitching, joint swelling, muscle stiffness, pain including muscle pain, neck pain.
Icelandic: Vöðvakippir, liðbólga, vöðvastífleiki, verkir þ.m.t. vöðvaverkir, verkur í hálsi
English: STATEMENT OF ACTIVE SUBSTANCE Each hard capsule contains 150 mg of pregabalin.
Icelandic: VIRK(T) EFNI Hvert hart hylki inniheldur 150 mg pregabalín
English: STATEMENT OF ACTIVE SUBSTANCE Each hard capsule contains 200 mg of pregabalin.
Icelandic: VIRK(T) EFNI Hvert hart hylki inniheldur 200 mg pregabalín
English: Excipient with known effect: Each hard capsule also contains 10 mg lactose monohydrate.
Icelandic: Hvert hart hylki inniheldur einnig 10 mg laktósaeinhýdrat.
English: • Feeling of elation, confusion, disorientation, decrease in sexual interest, irritability.
Icelandic: Vellíðunartilfinning, ringlun, vistarfirring, minnkaður áhugi á kynlífi, skapstyggð
English: Anorexia, hypoglycaemia
Icelandic: Lifrarbilun, lifrarbólga
English: 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg and 300 mg hard capsules are packed into PVC/alu blisters as primary packaging.
Icelandic: Pregabalin Zentiva k.s. 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg og 300 mg hörð hylki eru í PVC/álþynnum sem innri umbúðum.
English: 225 mg hard capsules Pregabalin Zentiva k.s.
Icelandic: Pregabalin Zentiva k.s. 225 mg hörð hylki Pregabalín
English: STATEMENT OF ACTIVE SUBSTANCE Each hard capsule contains 300 mg of pregabalin.
Icelandic: VIRK(T) EFNI Hvert hart hylki inniheldur 300 mg pregabalín
English: 200 mg capsules Flesh opaque cap and Flesh opaque body; approx. 19,4 mm in length, hard gelatin capsule with imprinting “200”, containing almost white powder.
Icelandic: Húðlit ógegnsæ hetta og húðlitur ógegnsærbolur; hart gelatínuhylki u.þ.b. 19,4 mm að lengd með áletruninni „200“ inniheldur svo til hvítt duft.
English: Hepatic failure, hepatitis
Icelandic: Lystarleysi, blóðsykurslækkun
English: Vomiting, nausea, constipation, diarrhoea, flatulence, abdominal distension, dry mouth
Icelandic: Munnþurrkur, hægðatregða, uppköst, vindgangur, niðurgangur, ógleði, þaninn kviður
English: 100 mg hard capsules Pregabalin Zentiva k.s.
Icelandic: Pregabalin Zentiva k.s. 100 mg hörð hylki Pregabalín
English: • Dry eyes, eye swelling, eye pain, weak eyes, watery eyes, eye irritation.
Icelandic: Augnþurrkur, augnbólga, augnverkur, augnþreyta, vot augu, erting í augum
English: 150 mg hard capsules Pregabalin Zentiva k.s.
Icelandic: Pregabalin Zentiva k.s. 150 mg hörð hylki
English: Hepatic impairment
Icelandic: Innihald hylkja
English: STATEMENT OF ACTIVE SUBSTANCE Each hard capsule contains 75 mg of pregabalin.
Icelandic: VIRK(T) EFNI Hvert hart hylki inniheldur 75 mg pregabalín
English: Excipient with known effect: Each hard capsule also contains 5 mg lactose monohydrate.
Icelandic: Hvert hart hylki inniheldur einnig 5 mg laktósaeinhýdrat.
English: and a serious skin reaction characterized by rash, blisters, peeling skin and pain).
Icelandic: Ofnæmisviðbrögð (geta m.a. verið erfiðleikar við andardrátt, bólga í augum (glærubólga) og alvarleg húðviðbrögð sem einkennast af útbrotum, blöðrum í húð, flögnun húðar og verkjum)
English: Generalised oedema, face oedema, chest tightness, pain, pyrexia, thirst, chills, asthenia
Icelandic: Útbreiddur bjúgur, andlitsbjúgur, þyngsli fyrir brjósti, verkur, hiti, þorsti, kuldahrollur, þróttleysi
English: Convulsions, including status epilepticus and grand mal convulsions, may occur during pregabalin use or shortly after discontinuing pregabalin.
Icelandic: Meðan á notkun pregabalíns stendur eða stuttu eftir að notkun pregabalíns er hætt geta krampar komið fram þ.m.t. flogafár og krampaflog (grand mal convulsions).
English: Yellow iron oxide (E172) Titanium dioxide (E171) Gelatin.
Icelandic: - Svart járnoxíð (E172) - Títantvíoxíð (E171) - Gelatína.
English: 75 mg hard capsules Pregabalin Zentiva k.s.
Icelandic: Pregabalin Zentiva k.s. 75 mg hörð hylki Pregabalín
English: In accordance with current clinical practice, some diabetic patients who gain weight on pregabalin treatment may need to adjust hypoglycaemic medicinal products.
Icelandic: Klínísk reynsla bendir til þess að breyta þurfi skammti sykursýkilyfja hjá sumum sjúklingum með sykursýki sem þyngjast meðan á pregabalínmeðferð stendur.
English: STATEMENT OF ACTIVE SUBSTANCE Each hard capsule contains 100 mg of pregabalin.
Icelandic: VIRK(T) EFNI Hvert hart hylki inniheldur 100 mg pregabalín
English: • Abnormal sense of smell, swinging vision, altered perception of depth, visual brightness, vision loss.
Icelandic: Óeðlilegt lyktarskyn, sveiflusýni, breyting á dýptarsjónskyni, ofbirta, sjónmissir
English: Adjunctive treatment
Icelandic: Viðbótarmeðferð
English: Excipient with known effect: Each hard capsule also contains 15 mg lactose monohydrate.
Icelandic: Hvert hart hylki inniheldur einnig 15 mg laktósaeinhýdrat.
English: Neuropathic pain
Icelandic: Ofurnæm heyrn
English: Euphoric mood, confusion, irritability, disorientation, insomnia, libido decreased
Icelandic: Vellíðunartilfinning, ringlun, skapstyggð, vistarfirring, svefnleysi, minnkuð kynhvöt
English: Elderly patients may require a dose reduction of pregabalin due to a decreased renal function (see section 5.2).
Icelandic: Með hliðsjón af minnkaðri nýrnastarfsemi með hækkandi aldri getur þurft að breyta skömmtum hjá öldruðum sjúklingum (sjá kafla 5.2).
English: STATEMENT OF ACTIVE SUBSTANCE Each hard capsule contains 50 mg of pregabalin.
Icelandic: VIRK(T) EFNI Hvert hart hylki inniheldur 50 mg pregabalín
English: Joint swelling, myalgia, muscle twitching, neck pain, muscle stiffness
Icelandic: Liðbólga, vöðvaþrautir, vöðvakippir, hálsverkur, vöðvastífleiki
English: Muscle cramp, arthralgia, back pain, pain in limb, cervical spasm
Icelandic: Sinadráttur, liðverkur, bakverkur, verkur í útlimum, hálskrampi
English: Hard capsule
Icelandic: Hart hylki.
English: Oedema peripheral, oedema, gait abnormal, fall, feeling drunk, feeling abnormal, fatigue
Icelandic: dofatilfinning, doði, slæving, drungi, svefnleysi, þreyta, óeðlileg líðan
English: • Feeling drunk, abnormal style of walking.
Icelandic: Ölvunartilfinning, óeðlilegt göngulag
English: Very common: may affect more than 1 in 10 people • Dizziness, drowsiness, headache.
Icelandic: Mjög algengar: geta komið fyrir hjá fleiri en 1 af hverjum 10 einstaklingum •
English: Dyspnoea, epistaxis, cough, nasal congestion, rhinitis, snoring, nasal dryness
Icelandic: Ofnæmi, andlitsbjúgur, kláði, ofsakláði, nefrennsli, blóðnasir, hósti, hrotur
English: LIST OF EXCIPIENTS Contains lactose monohydrate.
Icelandic: Laktósaóþol Pregabalin Zentiva k.s. inniheldur laktósaeinhýdrat.
English: • Increased saliva production, heartburn, numb around mouth.
Icelandic: Aukin munnvatnsframleiðsla, brjóstsviði, dofi umhverfis munn
English: 25 mg hard capsules Capsule cap and body Black iron oxide (E172) Titanium dioxide (E171) Gelatin
Icelandic: Pregabalin Zentiva k.s. 225 mg hörð hylki Hylkishetta - Rautt járnoxíð (E172) - Gult járnoxíð (E172) - Títantvíoxíð (E171) - Gelatína
English: 25 mg hard capsules Pregabalin Zentiva k.s.
Icelandic: 16. UPPLÝSINGAR MEÐ BLINDRALETRI Pregabalin Zentiva k.s. 25 mg
English: 50 mg hard capsules Pregabalin Zentiva k.s.
Icelandic: Pregabalin Zentiva k.s. 50 mg hörð hylki
English: Rash papular, urticaria, hyperhidrosis, pruritus
Icelandic: LOTUNÚMER<, AUÐKENNI GJAFAR OG LYFS>
English: In the post-marketing experience, the most commonly reported adverse reactions observed when pregabalin was taken in overdose included somnolence, confusional state, agitation, and restlessness.
Icelandic: Áhrifin af því að nota stærri Pregabalin Zentiva k.s. skammt en mælt er fyrir um geta verið syfja, ringlun, pirringur eða eirðarleysi.
English: Convulsions, parosmia, hypokinesia, dysgraphia
Icelandic: Útbrot með smáþrymlum, ofsakláði, ofsvitnun, kláði
English: Red iron oxide (E172) Yellow iron oxide (E172) Titanium dioxide (E171) Gelatin
Icelandic: Pregabalin Zentiva k.s. 75 mg hörð hylki Hylkishetta - Rautt járnoxíð (E172) - Gult járnoxíð (E172) - Títantvíoxíð (E171) - Gelatína
English: 50 mg hard capsules Capsule cap and body Black iron oxide (E172) Titanium dioxide (E171) Gelatin
Icelandic: Pregabalin Zentiva k.s. 200 mg hörð hylki Hylkisbolur og hetta - Rautt járnoxíð (E172) - Gult járnoxíð (E172) - Títantvíoxíð (E171) - Gelatína
English: 150 mg hard capsules Capsule cap and body
Icelandic: Pregabalin Zentiva k.s. 150 mg hörð hylki Hylkisbolur og hetta
English: DATE OF FIRST AUTHORISATION / RENEWAL OF THE AUTHORISATION Date of first authorisation: 27 February 2017.
Icelandic: 27. febrúar 2017.
English: Disinhibition
Icelandic: Lyfjagjöf
English: You should discuss this with your doctor.
Icelandic: Þú skalt ræða þetta við lækninn.
English: See also section 2 Warnings and precautions.
Icelandic: Sjá einnig kafla 2 Varnaðarorð og varúðarreglur.
English: Median change at week 13
Icelandic: Miðgildi breytingar í 13. viku
English: Tablets should be swallowed with water.
Icelandic: Töflurnar skal gleypa með vatni.
English: Gedeon Richter Plc, 1103 Budapest Gyömrői út 19-21 Hungary
Icelandic: Gedeon Richter Plc, 1103 Budapest Gyömrői út 19-21 Ungverjalandi
English: THE TABLE BELOW HELPS YOU TO TRACK YOUR BLOOD TESTS:
Icelandic: TAFLAN HÉR FYRIR NEÐAN HJÁLPAR ÞÉR AÐ FYLGJAST MEÐ BLÓÐPRUFUNUM:
English: The tablet should be swallowed with water and may be taken with or without food.
Icelandic: Töfluna skal gleypa með vatni og má taka með eða án matar.
English: Patients starting treatment course 2 or 4
Icelandic: Sjúklingar sem byrja á meðferðartímabili 2 eða 4
English: The safety for a human embryo is unknown.
Icelandic: Öryggi fyrir fósturvísa manna er ekki þekkt.
English: A risk to the newborns/infants cannot be excluded.
Icelandic: Ekki er hægt að útiloka áhættu fyrir nýbura/ungbörn.
English: Tablets may be taken with or without food.
Icelandic: Taka má töflurnar hvort sem er með eða án matar.
English: Alu/PVC/PE/PVDC or Alu/PVC/PVDC blister.
Icelandic: ál/PVC/PE/PVDC eða ál/PVC/PVDC þynnupakkning.
English: ATC code: G03XB02.
Icelandic: G03XB02.
English: Esmya can cause side effects although not everybody gets them.
Icelandic: Esmya getur valdið aukaverkunum en það gerist þó ekki hjá öllum.
English: During each course of treatment, do not stop taking your tablets without the advice of your doctor even if you feel better, as symptoms may re-occur later.
Icelandic: Hættu ekki að taka töflurnar á hverju meðferðartímabili án þess að ráðfæra þig við lækninn, jafnvel þótt þér líði betur, því einkennin geta tekið sig upp aftur síðar.
English: The effect on newborn/infants has not been studied.
Icelandic: Áhrif þess á nýbura/ungbörn hafa ekki verið rannsökuð.
English: Do not drive or use machines if you experience these symptoms.
Icelandic: Ekki má aka eða nota vélar ef vart verður við slík einkenni.
English: Pack of 28, 30 and 84 tablets.
Icelandic: Pakkning með 28, 30 og 84 töflum.
English: The doctor should check your liver immediately and decide if you can continue the treatment.
Icelandic: Læknirinn á að athuga lifrina tafarlaust og ákvarða hvort halda skuli meðferðinni áfram.
English: You should always start taking Esmya within the first week of your menstrual period.
Icelandic: Þú skalt ávallt byrja að nota Esmya innan fyrstu viku tíðahrings.
English: There have been no reports of serious harmful effects from taking several doses of this medicine at once.
Icelandic: Engar tilkynningar hafa verið um alvarlegar skaðlegar verkanir af því að taka nokkra skammta af lyfinu í einu.
English: 17 rue de Pontoise F-95520 Osny France
Icelandic: 17 rue de Pontoise F-95520 Osny Frakkland
English: - if you are pregnant or if you are breastfeeding.
Icelandic: - ef þú ert þunguð eða með barn á brjósti.
English: These tests need to happen every month, including a few weeks after you finish a course of treatment (see schedule below).
Icelandic: Þessar blóðprufur verða að fara fram mánaðarlega, þar með talið nokkrum vikum eftir að meðferðarlotu er lokið (sjá áætlunina hér fyrir neðan).
English: Frequency Not known
Icelandic: Tíðni ekki þekkt