FrancophonIA/ELRC3.0 huggingface dataset:
English: Available in blister packs containing 14, 56, 100 capsules, in perforated unit dose blister packs containing 14 x 1, 56 x 1, 100 x 1 capsules and in bottles containing 200 capsules.
Icelandic: Fáanlegt í þynnupakkningum sem innihalda 14, 56, 100 hylki, í rifgötuðum þynnupakkningum sem innihalda 14 x 1, 56 x 1, 100 x 1 hylki og í glösum sem innihalda 200 hylki.
English: Do not take Pregabalin Mylan Pharma: If you are allergic to pregabalin or any of the other ingredients of this medicine (listed in section 6).
Icelandic: ef um er að ræða ofnæmi fyrir pregabalíni eða einhverju öðru innihaldsefni lyfsins (talin upp í kafla 6).
English: STATEMENT OF ACTIVE SUBSTANCE Each hard capsule contains 150 mg pregabalin.
Icelandic: VIRK(T) EFNI Hvert hart hylki inniheldur 150 mg pregabalín.
English: Hypersensitivity Angioedema, allergic reaction
Icelandic: Ofsabjúgur, ofnæmisviðbrögð.
English: STATEMENT OF ACTIVE SUBSTANCE Each hard capsule contains 300 mg pregabalin.
Icelandic: VIRK(T) EFNI Hvert hart hylki inniheldur 300 mg pregabalín.
English: After discontinuation of short-term and long-term treatment with pregabalin withdrawal symptoms have been observed in some patients.
Icelandic: Fráhvarfseinkenni hafa komið fram hjá sumum sjúklingum þegar skammtíma- og langtímameðferð með pregabalíni hefur verið hætt.
English: Available in blister packs containing 14, 21, 56, 84, 100 capsules and in perforated unit dose blister packs containing 56 x 1, 84 x 1, 100 x 1 capsules.
Icelandic: Fáanlegt í þynnupakkningum sem innihalda 14, 21, 56, 84, 100 hylki og í rifgötuðum þynnupakkningum sem innihalda 56 x 1, 84 x 1, 100 x 1 hylki.
English: Pregabalin Mylan Pharma 225 mg hard capsules EU/1/15/998/040
Icelandic: Mylan Pharma 225 mg hörð hylki EU/1/15/998/040
English: Pregabalin Mylan Pharma 200 mg hard capsules EU/1/15/998/035
Icelandic: Mylan Pharma 200 mg hörð hylki EU/1/15/998/035
English: Pregabalin Mylan Pharma 75 mg hard capsule
Icelandic: Mylan Pharma 75 mg hart hylki
English: Pregabalin pharmacokinetics are linear over the recommended daily dose range.
Icelandic: Lyfjahvörf pregabalíns eru línuleg innan ráðlagðra sólarhringsskammta.
English: If you have the impression that the effect of Pregabalin Mylan Pharma is too strong or too weak, talk to your doctor or pharmacist.
Icelandic: Leitaðu til læknis eða lyfjafræðings ef þér finnst áhrif Pregabalin Mylan Pharma vera of mikil eða of lítil.
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: UNIQUE IDENTIFIER - 2D BARCODE <2D barcode carrying the unique identifier included.>
Icelandic: 17. EINKVÆMT AUÐKENNI - TVÍVÍTT STRIKAMERKI Á pakkningunni er tvívítt strikamerki með einkvæmu auðkenni.
English: The capsule is axially printed with MYLAN over PB225 in black ink on cap and body.
Icelandic: Áslæg prentun er á hylkinu sem er merkt með MYLAN fyrir ofan PB225 með svörtu bleki á efri og neðri hluta þess.
English: Pregabalin Mylan Pharma 300 mg hard capsules EU/1/15/998/045
Icelandic: Mylan Pharma 300 mg hörð hylki EU/1/15/998/045
English: • Feeling of elation, confusion, disorientation, decrease in sexual interest, irritability
Icelandic:  Vellíðunartilfinning, ringlun, vistarfirring, minnkaður áhugi á kynlífi, skapstyggð.
English: Pregabalin Mylan Pharma 225 mg hard capsule
Icelandic: Mylan Pharma 225 mg hart hylki
English: What Pregabalin Mylan Pharma contains
Icelandic: Mylan Pharma inniheldur
English: Pregabalin Mylan Pharma 150 mg hard capsules EU/1/15/998/028
Icelandic: Mylan Pharma 150 mg hörð hylki EU/1/15/998/028
English: Pregabalin Mylan Pharma 150 mg hard capsule
Icelandic: Mylan Pharma 150 mg hart hylki
English: Dose regimen
Icelandic: Til inntöku.
English: Available in blister packs containing 14, 56, 100 capsules, in perforated unit dose blister packs containing 56 x 1, 100 x 1 capsules and in bottles containing 200 capsules.
Icelandic: Fáanlegt í þynnupakkningum sem innihalda 14, 56, 100 hylki, í rifgötuðum þynnupakkningum sem innihalda 56 x 1, 100 x 1 hylki og í glösum sem innihalda 200 hylki.
English: • Dry eyes, eye swelling, eye pain, weak eyes, watery eyes, eye irritation
Icelandic:  Augnþurrkur, augnbólga, augnverkur, augnþreyta, vot augu, erting í augum.
English: STATEMENT OF ACTIVE SUBSTANCE Each hard capsule contains 100 mg pregabalin.
Icelandic: VIRK(T) EFNI Hvert hart hylki inniheldur 100 mg pregabalín.
English: Elevated liver enzymes Jaundice
Icelandic: YTRI UMBÚÐUM YTRI ASKJA
English: In addition, pregabalin is effectively removed from plasma by haemodialysis (following a 4 hour haemodialysis treatment plasma pregabalin concentrations are reduced by approximately 50%).
Icelandic: Pregabalín er auk þess fjarlægt á áhrifaríkan hátt úr plasma með blóðskilun (eftir 4 klst.
English: • Changes in blood and liver test results (blood creatinine phosphokinase increased, alanine aminotransferase increased, aspartate aminotransferase increased, platelet count decreased,
Icelandic:  Breytingar á niðurstöðum blóðrannsókna og lifrarprófa (hækkun á kreatínfosfókínasa í blóði,
English: PVC/PVDC-Al perforated unit dose blister pack containing 56 x 1, 84 x 1 and 100 x 1 hard capsules.
Icelandic: PVC/PVDC-ál rifgötuð stakskammtaþynnupakkning sem inniheldur 56 x 1, 84 x 1 eða 100 x 1 hörð hylki.
English: Hepatic impairment
Icelandic: Almenn kvíðaröskun
English: The incidence of adverse reactions in general, CNS adverse reactions and especially somnolence was increased in the treatment of central neuropathic pain due to spinal cord injury (see section
Icelandic: Við meðferð á miðlægum taugaverkjum í kjölfar mænuskaða kom fram aukin tíðni aukaverkana almennt og aukaverkana frá miðtaugakerfi, sérstaklega svefnhöfgi (sjá kafla 4.4).
English: Pregabalin Mylan Pharma 200 mg hard capsule
Icelandic: Mylan Pharma 200 mg hart hylki
English: INFORMATION IN BRAILLE Pregabalin Mylan Pharma 150 mg
Icelandic: Mylan Pharma 150 mg
English: 6.1 List of excipients
Icelandic: 3. FYRNINGARDAGSETNING EXP
English: No. 4, light peach opaque cap and white opaque body, hard-shell gelatin capsule filled with white to off-white powder.
Icelandic: Stærð nr. 4 með ljósferskjulituðum möttum efri hluta og hvítum möttum neðri hluta, gelatínhylki með harðri skel sem fyllt er með hvítu til beinhvítu dufti.
English: Cases of renal failure have been reported and in some cases discontinuation of pregabalin did show reversibility of this adverse reaction.
Icelandic: Greint hefur verið frá tilfellum nýrnabilunar og í sumum tilvikum gekk aukaverkunin til baka eftir að meðferð með pregabalíni var hætt.
English: • Dry mouth, constipation, vomiting, flatulence, diarrhoea, nausea, swollen abdomen
Icelandic:  Munnþurrkur, hægðatregða, uppköst, vindgangur, niðurgangur, ógleði, uppþemba.
English: STATEMENT OF ACTIVE SUBSTANCE Each hard capsule contains 50 mg pregabalin.
Icelandic: VIRK(T) EFNI Hvert hart hylki inniheldur 50 mg pregabalín.
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: Reporting of side effects
Icelandic: Áhrif tengd sjón
English: Available in blister packs containing 14, 21, 56, 84, 100 capsules and in perforated unit dose blister packs containing 84 x 1, 100 x 1 capsules.
Icelandic: Fáanlegt í þynnupakkningum sem innihalda 14, 21, 56, 84, 100 hylki og í rifgötuðum þynnupakkningum sem innihalda 84 x 1, 100 x 1 hylki.
English: Pregabalin Mylan Pharma 300 mg hard capsule
Icelandic: Mylan Pharma 300 mg hart hylki
English: STATEMENT OF ACTIVE SUBSTANCE Each hard capsule contains 25 mg pregabalin.
Icelandic: VIRK(T) EFNI Hvert hart hylki inniheldur 25 mg pregabalín.
English: Available in blister packs containing 14, 56, 100 capsules and in perforated unit dose blister packs containing 56 x 1, 100 x 1 capsules.
Icelandic: Fáanlegt í þynnupakkningum sem innihalda 14, 56, 100 hylki og í rifgötuðum þynnupakkningum sem innihalda 56 x 1, 100 x 1 hylki.
English: Pregabalin Mylan Pharma 50 mg hard capsules EU/1/15/998/009
Icelandic: Mylan Pharma 50 mg hörð hylki EU/1/15/998/009
English: Oral use.
Icelandic:  Skriftarerfiðleikar.
English: INFORMATION IN BRAILLE Pregabalin Mylan Pharma 225 mg
Icelandic: Mylan Pharma 225 mg
English: Pregabalin Mylan Pharma 100 mg hard capsule
Icelandic: Mylan Pharma 100 mg hart hylki
English: Musculoskeletal and connective tissue disorders
Icelandic: 16. UPPLÝSINGAR MEÐ BLINDRALETRI Pregabalin
English: BATCH NUMBER Lot
Icelandic: HEITI LYFS
English: 14 hard capsules 21 hard capsules 56 hard capsules 84 hard capsules 100 hard capsules 56 x 1 hard capsules 84 x 1 hard capsules 100 x 1 hard capsules
Icelandic: 14 hörð hylki 21 hart hylki 56 hörð hylki 84 hörð hylki 100 hörð hylki 56 x 1 hörð hylki 84 x 1 hörð hylki 100 x 1 hörð hylki
English: PVC/PVDC-Al perforated unit dose blister pack containing 84 x 1 and 100 x 1 hard capsules.
Icelandic: PVC/PVDC-ál rifgötuð stakskammtaþynnupakkning sem inniheldur 84 x 1 eða 100 x 1 hörð hylki.
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 sykursýkislyfja hjá sumum sjúklingum með sykursýki sem þyngjast meðan á pregabalínmeðferð stendur.
English: The capsule is axially printed with MYLAN over PB150 in black ink on cap and body.
Icelandic: Áslæg prentun er á hylkinu sem er merkt með MYLAN fyrir ofan PB150 með svörtu bleki á efri og neðri hluta þess.
English: Pregabalin Mylan Pharma 25 mg hard capsules EU/1/15/998/001
Icelandic: Mylan Pharma 25 mg hörð hylki EU/1/15/998/001
English: PVC/PVDC-Al perforated unit dose blister pack containing 14 x 1, 56 x 1 and 100 x 1 hard capsules.
Icelandic: PVC/PVDC-ál rifgötuð stakskammtaþynnupakkning sem inniheldur 14 x 1, 56 x 1 eða 100 x 1 hörð hylki.
English: Erectile dysfunction
Icelandic: Ónæmiskerfi
English: INFORMATION IN BRAILLE Pregabalin Mylan Pharma 300 mg
Icelandic: Mylan Pharma 300 mg
English: INFORMATION IN BRAILLE Pregabalin Mylan Pharma 200 mg
Icelandic: Mylan Pharma 200 mg
English: Adverse drug reactions
Icelandic: LYFJAFRÆÐILEGAR UPPLÝSINGAR
English: The capsule is axially printed with MYLAN over PB75 in black ink on cap and body.
Icelandic: Áslæg prentun er á hylkinu sem er merkt með MYLAN fyrir ofan PB75 með svörtu bleki á efri og neðri hluta þess.
English: Pregabalin Mylan Pharma 50 mg hard capsule
Icelandic: Mylan Pharma 50 mg hart hylki
English: 14 hard capsules 21 hard capsules 56 hard capsules 84 hard capsules 100 hard capsules 84 x 1 hard capsules 100 x 1 hard capsules
Icelandic: 14 hörð hylki 21 hart hylki 56 hörð hylki 84 hörð hylki 100 hörð hylki 84 x 1 hörð hylki 100 x 1 hörð hylki
English: 14 hard capsules 56 hard capsules 100 hard capsules 200 hard capsules 14 x 1 hard capsules 56 x 1 hard capsules 100 x 1 hard capsules
Icelandic: 14 hörð hylki 56 hörð hylki 100 hörð hylki 200 hörð hylki 14 x 1 hörð hylki 56 x 1 hörð hylki 100 x 1 hörð hylki
English: INFORMATION IN BRAILLE Pregabalin Mylan Pharma 100 mg
Icelandic: Mylan Pharma 100 mg
English: The capsule is axially printed with MYLAN over PB200 in black ink on cap and body.
Icelandic: Áslæg prentun er á hylkinu sem er merkt með MYLAN fyrir ofan PB200 með svörtu bleki á efri og neðri hluta þess.
English: Hepatic failure, hepatitis
Icelandic: Lystarleysi, blóðsykurslækkun.
English: Pregabalin Mylan Pharma 25 mg hard capsule
Icelandic: Mylan Pharma 25 mg hart hylki
English: Total pregabalin daily dose *
Icelandic: Heildarskammtur af pregabalíni á sólarhring*
English: INFORMATION IN BRAILLE Pregabalin Mylan Pharma 75 mg
Icelandic: Mylan Pharma 75 mg
English: Pregabalin has been studied in 3 controlled clinical trials of 12 week duration with either BID or TID dosing.
Icelandic: Skömmtun pregabalíns annaðhvort tvisvar eða þrisvar á sólarhring hefur verið rannsökuð í 3 klínískum samanburðarrannsóknum sem stóðu í 12 vikur.
English: What you need to know before you take Pregabalin Mylan Pharma 3.
Icelandic: Áður en byrjað er að nota Pregabalin Mylan Pharma 3.
English: Muscle cramp, arthralgia, back pain, pain in limb, cervical spasm
Icelandic: Vöðvakrampar, liðverkir, bakverkur, verkur í útlimum, hálskrampi.
English: NAME OF THE MEDICINAL PRODUCT Pregabalin Mylan Pharma 200 mg hard capsules pregabalin
Icelandic: Mylan Pharma 200 mg hörð hylki pregabalín
English: Ataxia, coordination abnormal, tremor, dysarthria, amnesia, memory impairment, disturbance in attention, paraesthesia, hypoaesthesia, sedation, balance disorder, lethargy
Icelandic:  Eftirtektarleysi, klaufaskapur, minnistruflun, minnisleysi, skjálfti, talörðugleikar, dofatilfinning,
English: NAME OF THE MEDICINAL PRODUCT Pregabalin Mylan Pharma 225 mg hard capsules pregabalin
Icelandic: Mylan Pharma 225 mg hörð hylki pregabalín
English: Vomiting, nausea, constipation, diarrhoea, flatulence, abdominal distension, dry mouth
Icelandic: Uppköst, ógleði, hægðatregða, niðurgangur, vindgangur, uppþemba, munnþurrkur.
English: NAME OF THE MEDICINAL PRODUCT Pregabalin Mylan Pharma 300 mg hard capsules pregabalin
Icelandic: Mylan Pharma 300 mg hörð hylki pregabalín
English: The capsule is axially printed with MYLAN over PB300 in black ink on cap and body.
Icelandic: Áslæg prentun er á hylkinu sem er merkt með MYLAN fyrir ofan PB300 með svörtu bleki á efri og neðri hluta þess.
English: Light peach opaque cap and light peach opaque body, hard-shell gelatin capsule filled with white to off-white powder.
Icelandic: Ljósferskjulitaður mattur efri hluti og ljósferskjulitaður mattur neðri hluti, gelatínhylki með harðri skel sem fyllt er með hvítu til beinhvítu dufti.
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 komið fram krampar, þ.m.t. flogafár og krampaflog (grand mal convulsions).
English: PVC/PVDC-Al perforated unit dose blister pack containing 56 x 1 and 100 x 1 hard capsules.
Icelandic: PVC/PVDC-ál rifgötuð stakskammtaþynnupakkning sem inniheldur 56 x 1 eða 100 x 1 hörð hylki.
English: OTHER
Icelandic: UPPLÝSINGAR
English: NAME OF THE MEDICINAL PRODUCT Pregabalin Mylan Pharma 150 mg hard capsules pregabalin
Icelandic: Mylan Pharma 150 mg hörð hylki pregabalín
English: Single dose+
Icelandic: eftir lyfjagjöf.
English: • Increased appetite
Icelandic: C. AÐRAR FORSENDUR
English: The capsule is axially printed with MYLAN over PB25 in black ink on cap and body.
Icelandic: Áslæg prentun er á hylkinu sem er merkt með MYLAN fyrir ofan PB25 með svörtu bleki á efri og neðri hluta þess.
English: Convulsion, parosmia, hypokinesia, dysgraphia
Icelandic: Útbrot með smáþrymlum, ofsakláði, ofsvitnun, kláði.
English: 14 hard capsules 56 hard capsules 100 hard capsules 200 hard capsules 56 x 1 hard capsules 100 x 1 hard capsules
Icelandic: 14 hörð hylki 56 hörð hylki 100 hörð hylki 200 hörð hylki 56 x 1 hörð hylki 100 x 1 hörð hylki
English: The capsule is axially printed with MYLAN over PB50 in black ink on cap and body.
Icelandic: Áslæg prentun er á hylkinu sem er merkt með MYLAN fyrir ofan PB50 með svörtu bleki á efri og neðri hluta þess.
English: The capsule is axially printed with MYLAN over PB100 in black ink on cap and body.
Icelandic: Áslæg prentun er á hylkinu sem er merkt með MYLAN fyrir ofan PB100 með svörtu bleki á efri og neðri hluta þess.
English: Light peach opaque cap and white opaque body, hard-shell gelatin capsule filled with white to off-white powder.
Icelandic: Ljósferskjulitaður mattur efri hluti og hvítur mattur neðri hluti, gelatínhylki með harðri skel sem fyllt er með hvítu til beinhvítu dufti.
English: Generalised Anxiety Disorder
Icelandic: Samhliða meðferð með flogaveikilyfjum hætt
English: NAME OF THE MEDICINAL PRODUCT Pregabalin Mylan Pharma 100 mg hard capsules pregabalin
Icelandic: Mylan Pharma 100 mg hörð hylki pregabalín
English: Elimination
Icelandic: Ristruflun
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: If you experience a convulsion, contact your doctor immediately.
Icelandic: Hafðu samstundis samband við lækninn ef þú færð krampa.
English: NAME OF THE MEDICINAL PRODUCT Pregabalin Mylan Pharma 75 mg hard capsules pregabalin
Icelandic: Mylan Pharma 75 mg hörð hylki pregabalín
English: 14 hard capsules 56 hard capsules 100 hard capsules 56 x 1 hard capsules 100 x 1 hard capsules
Icelandic: 14 hörð hylki 56 hörð hylki 100 hörð hylki 56 x 1 hörð hylki 100 x 1 hörð hylki
English: Pregabalin Mylan Pharma 50 mg hard capsules PVC/PVDC-Al blister pack containing 14, 21, 56, 84 and 100 hard capsules.
Icelandic: PVC/PVDC-álþynnupakkning sem inniheldur 14, 21, 56, 84 eða 100 hörð hylki.
English: These reactions are mostly seen in elderly cardiovascular compromised patients during pregabalin treatment for a neuropathic indication.
Icelandic: Aukaverkanirnar koma oftast fyrir hjá öldruðum sjúklingum sem eru með veikara hjarta- og æðakerfi sem fá pregabalínmeðferð við taugaverkjum.
English: • Hepatitis (inflammation of the liver).
Icelandic: Hömluleysi (disinhibition).
English: NAME OF THE MEDICINAL PRODUCT Pregabalin Mylan Pharma 50 mg hard capsules pregabalin
Icelandic: Mylan Pharma 50 mg hörð hylki pregabalín
English: Dyspnoea, epistaxis, cough, nasal congestion, rhinitis, snoring, nasal dryness
Icelandic:  Ofnæmi, andlitsbjúgur, kláði, ofsakláði, nefrennsli, blóðnasir, hósti, hrotur.
English: Shellac
Icelandic: Brotthvarf
English: Euphoric mood, confusion, irritability, disorientation, insomnia, libido decreased
Icelandic: Vellíðunartilfinning, ringlun, skapstyggð, vistarfirring, svefnleysi, minnkuð kynhvöt.
English: NAME OF THE MEDICINAL PRODUCT Pregabalin Mylan Pharma 25 mg hard capsules pregabalin
Icelandic: Mylan Pharma 25 mg hörð hylki pregabalín
English: The 50 mg capsules are No. 3, dark peach opaque cap and white opaque body, hard-shell gelatin capsule filled with white to off-white powder.
Icelandic: Stærð nr. 3 með dökkferskjulituðum möttum efri hluta og dökkferskjulituðum möttum neðri hluta, gelatínhylki með harðri skel sem fyllt er með hvítu til beinhvítu dufti.
English: Dark peach opaque cap and white opaque body, hard-shell gelatin capsule filled with white to off-white powder.
Icelandic: Dökkferskjulitaður mattur efri hluti og hvítur mattur neðri hluti, gelatínhylki með harðri skel sem fyllt er með hvítu til beinhvítu dufti.
English: BID or TID BID or TID
Icelandic: B. FORSENDUR FYRIR, EÐA TAKMARKANIR Á, AFGREIÐSLU OG NOTKUN
English: • Loss of appetite, weight loss, low blood sugar, high blood sugar
Icelandic: Sjaldgæfar: geta komið fram hjá allt að 1 af hverjum 100 einstaklingum  Minnkuð matarlyst, þyngdartap, lágur blóðsykur, hár blóðsykur.
English: България Майлан ЕООД
Icelandic: Mylan bvba/sprl
English: • Disturbance in attention, clumsiness, memory impairment, loss of memory, tremor, difficulty with speaking, tingling feeling, numbness, sedation, lethargy, insomnia, fatigue, feeling abnormal
Icelandic: Ósamhæfing hreyfinga, skortur á samhæfingu, skjálfti, tormæli, minnisleysi, minnistruflun, einbeitingarskortur, náladofi, snertiskynsminnkun, róun, jafnvægistruflun, drungi.
English: Dark peach opaque cap and dark peach opaque body, hard-shell gelatin capsule filled with white to off-white powder.
Icelandic: Dökkferskjulitaður mattur efri hluti og dökkferskjulitaður mattur neðri hluti, gelatínhylki með harðri skel sem fyllt er með hvítu til beinhvítu dufti.
English: Pregabalin Mylan Pharma 150 mg hard capsules PVC/PVDC-Al blister pack containing 14, 56 and 100 hard capsules.
Icelandic: PVC/PVDC-álþynnupakkning sem inniheldur 14, 56 eða 100 hörð hylki.
English: Metabolism and nutrition disorders Common
Icelandic: Mjög sjaldgæfar Efnaskipti og næring Algengar
English: Pharmacotherapeutic group: Anti-epileptics, other anti-epileptics, ATC code: N03AX16.
Icelandic: Flogaveikilyf, önnur flogaveikilyf ATC flokkur:
English: All ACS
Icelandic: Öll ACS
English: - If you have severe liver disease.
Icelandic: - ef þú ert með alvarlegan lifrarsjúkdóm.
English: Patients may be counted in more than one row.
Icelandic: Sjúklingar geta verið taldir í fleiri en einni röð.
English: Talk to your doctor before taking Efient.
Icelandic: Ræddu við lækninn áður en þú tekur Efient.
English: • ≥ 75 years of age (see below).
Icelandic: >75 ára aldri (sjá hér að neðan).
English: de la Industria 30 28108 Alcobendas Madrid
Icelandic: Avda. de la Industria 30 28108 Alcobendas Madrid
English: It is important that you tell your doctor, dentist and pharmacist, that you are taking Efient.
Icelandic: Það er mikilvægt að þú upplýsir lækni, tannlækni og lyfjafræðing að þú sért að taka Efient.
English: There is no difference in exposure among Chinese, Japanese, and Korean subjects.
Icelandic: Engin munur er á útsetningu milli kínverskra, japanskra og kóreanskra einstaklinga.
English: 85276 Pfaffenhofen Germany
Icelandic: 85276 Pfaffenhofen Þýskaland
English: You may take Efient with or without food.
Icelandic: Efient má taka með eða án matar.
English: OTHER <MON, TUE, WED, THU, FRI, SAT, SUN>
Icelandic: ANNAÐ <MÁN, ÞRI, MIÐ, FIM, FÖS, LAU, SUN>
English: Avda de la Industria 30 E-28108 Alcobendas (Madrid) Spain
Icelandic: Avda de la Industria 30 E-28108 Alcobendas (Madrid) Spánn
English: • Sudden dizziness or sudden severe headache with no known cause.
Icelandic: Skyndilegan svima eða mikinn skyndilegan höfuðverk án þekktrar ástæðu
English: The patient population was 92% Caucasian, 26% female, and 39% ≥ 65 years of age.
Icelandic: Sjúklingahópurinn var 92% af hvítum kynþætti, 26% konur, og 39% ≥ 65 ára aldri.
English: This concern applies especially to patients:
Icelandic: Þetta á sértaklega við um eftirfarandi sjúklinga:
English: Take your dose at around the same time every day.
Icelandic: Taktu skammtinn á svipuðum tíma alla daga.
English: No significant difference was seen in the STEMI population.
Icelandic: Ekki sást marktækur munur hjá STEMI hópnum.
English: What Efient is and what it is used for
Icelandic: Upplýsingar um Efient og við hverju það er notað
English: Efient was administered without regard to food in TRITON.
Icelandic: Efient var gefið án tilllits til fæðu í TRITON.
English: Therefore, prasugrel should be used with caution in these patients.
Icelandic: Því skal prasugrel notað með varúð hjá þessum sjúklinum.
English: The study failed to meet any of the primary or secondary endpoints.
Icelandic: Í rannsókninni tókst ekki að uppfylla neinn af aðal- né aukaendapunktum rannsóknarinnar.
English: Patients ≥60 kg and age <75 years
Icelandic: Sjúklingar ≥60 kg og <75 ára
English: The safety and efficacy of Efient in children below age 18 has not been established.
Icelandic: Ekki hefur verið sýnt fram á öryggi og verkun Efient hjá börnum yngri en 18 ára.
English: For the 14, 28, 56 84 and 98 tablet pack sizes, you can check the day on which you last took a tablet of Efient by referring to the calendar printed on the blister.
Icelandic: 14, 28, 56, 84 og 98 þá getur þú athugað hvenær síðasti skammtur var tekinn af Efient með því að skoða dagatalið á þynnunni.
English: These may be signs of a severe allergic reaction (see section 2 ‘What you need to know before you take Efient').
Icelandic: Þetta geta verið einkenni um alvarleg ofnæmisviðbrögð (sjá kafla 2 „Áður en byrjað er að taka Efient“).
English: Hazard Ratio (HR) (95% CI)
Icelandic: Áhættuhlutfall (95% CI)
English: Severe hepatic impairment (Child Pugh class C).
Icelandic: Alvarleg lifrarbilun (Child Pugh class C).