FrancophonIA/ELRC3.0 huggingface dataset:
English: Briviact contains the active substance brivaracetam.
Icelandic: Briviact inniheldur Virka innihaldsefnið brivaracetam.
English: 6.3 Shelf life
Icelandic: 1.HEITI LYFS
English: In the treated population, an increase in malformations has been noted with polytherapy; however, the extent to which the treatment and/or the underlying condition is responsible has not been elucidated.
Icelandic: Þó hefur ekki verið skýrt að hvaða marki það er vegna meðferðarinnar og/eða undirliggjandi sjúkdóms.
English: 0.05 ml/kg/intake
Icelandic: 0,05 ml/kg/gjöf
English: In a pharmacokinetic study with a 3-week evaluation period and weekly fixed 3-step up-titration using the brivaracetam oral solution, 99 subjects aged 1 month to <16 years were evaluated.
Icelandic: Metin voru 99 börn á aldrinum 1 mánaða til <16 ára í lyfjahvarfafræðilegri rannsókn með 3 vikna matstíma og fastri þriggja skrefa upptítrun með brivaracetam mixtúru, lausn.
English: 0.1 ml/kg/intake
Icelandic: 0,1 ml/kg/gjöf
English: Each film-coated tablet contains 10 mg brivaracetam.
Icelandic: Hver filmuhúðuð tafla inniheldur 10 mg brivaracetam.
English: One vial of 5 ml contains 50 mg brivaracetam.
Icelandic: Hvert 5 ml hettuglas inniheldur 50 mg brivaracetam.
English: Briviact 100 mg film-coated tablets
Icelandic: Briviact 100 mg filmuhúðaðar töflur
English: - Periodic safety update reports
Icelandic: Samantekt á upplýsingum um öryggi
English: For a dose of 1 mg/kg/day
Icelandic: Skammtur sem nemur 1 mg/kg/dag
English: Briviact 25 mg film-coated tablets
Icelandic: Briviact 25 mg filmuhúðaðar töflur
English: Any unused medicinal product, neat or diluted, or waste material should be disposed of in accordance with local requirements.
Icelandic: Farga skal öllum lyfjaleifum, óþynntum eða þynntum, og/eða úrgangi í samræmi við gildandi reglur.
English: 0.15 ml/kg/intake
Icelandic: 0,15 ml/kg/gjöf
English: Purple, oval film-coated tablets with dimensions of 13.0 mm x 7.3 mm debossed with ‘u75' on one side.
Icelandic: Fjólubláar, sporöskjulaga filmuhúðaðar töflur, 13,0 mm x 7,3 mm að stærð og auðkenndar með „u75“ á annarri hliðinni.
English: Briviact 10 mg film-coated tablets
Icelandic: Briviact 10 mg filmuhúðaðar töflur
English: - Briviact may be diluted before it is injected by your doctor or nurse.
Icelandic: - Læknirinn eða hjúkrunarfræðingur gætu þynnt Briviact fyrir inndælingu.
English: Contains sodium acetate (trihydrate), sodium chloride.
Icelandic: Inniheldur natríumasetat (þríhýdrat), natríumklóríð.
English: Iron oxide yellow (E172) Iron oxide black (E172).
Icelandic: Gult járnoxíð (E172) Svart járnoxíð (E172).
English: Sodium acetate (trihydrate) Acetic acid, glacial (for pH-adjustment) Sodium chloride
Icelandic: Vatnsfrí sítrónusýra (til að stilla pH)
English: Effects of other agents on the pharmacokinetics of brivaracetam In vitro data suggest that brivaracetam has a low interaction potential.
Icelandic: In vitro upplýsingar benda til að hugsanlegar milliverkanir við brivaracetam séu fáar.
English: Each film-coated tablet contains 100 mg brivaracetam.
Icelandic: Hver filmuhúðuð tafla inniheldur 100 mg brivaracetam.
English: MARKETING AUTHORISATION NUMBER(S)
Icelandic: 12.MARKAÐSLEYFISNÚMER
English: In rats, there was no effect on fertility with brivaracetam (see section 5.3).
Icelandic: Engin áhrif notkunar brivaracetams á frjósemi komu fram hjá rottum (sjá kafla 5.3).
English: Intake of brivaracetam with alcohol is not recommended.
Icelandic: Ekki er mælt með notkun brivaracetams með alkóhóli.
English: Briviact 10 mg/ml solution for injection/infusion
Icelandic: Briviact 10 mg/ml stungulyf/innrennslislyf, lausn
English: UNIQUE IDENTIFIER - 2D BARCODE
Icelandic: 17.EINKVÆMT AUÐKENNI - TVÍVÍTT STRIKAMERKI
English: What Briviact contains
Icelandic: Briviact inniheldur
English: 75 mg twice a day.
Icelandic: 1,5 mg fyrir hvert kíló líkamsþyngdar tvisvar sinnum á dag.
English: Briviact 10 mg/ml injection/infusion brivaracetam
Icelandic: Briviact 10 mg/ml stungulyf/innrennslislyf brivaracetam i.v.
English: For a dose of 3 mg/kg/day
Icelandic: Skammtur sem nemur 3 mg/kg/dag
English: Volumes of oral solution to be taken per administration
Icelandic: Magn lausnar um munn við hverja lyfjagjöf
English: If you have taken more Briviact than you should, talk to your doctor.
Icelandic: Ef notaður er stærri skammtur en mælt er fyrir um Hafði samband við lækninn ef þú notar meira af Briviact en þú átt að gera.
English: n = randomised patients who received at least 1 dose of study medication ~ Dose not studied
Icelandic: n = slembiraðaðir sjúklingar sem fengu a.m.k.
English: For a dose of 2 mg/kg/day
Icelandic: Skammtur sem nemur 2 mg/kg/dag
English: Each film-coated tablet contains 50 mg brivaracetam.
Icelandic: Hver filmuhúðuð tafla inniheldur 50 mg brivaracetam.
English: EU/1/15/1073/017 14 film-coated tablets EU/1/15/1073/018 56 film-coated tablets EU/1/15/1073/019 100 x 1 film-coated tablet EU/1/15/1073/027 14 x 1 film-coated tablet
Icelandic: EU/1/15/1073/017 14 filmuhúðaðar töflur EU/1/15/1073/018 56 filmuhúðaðar töflur EU/1/15/1073/019 100 x 1 filmuhúðuð tafla EU/1/15/1073/027 14 x 1 filmuhúðuð tafla
English: Each ml of oral solution contains 10 mg brivaracetam.
Icelandic: Hver ml af mixtúru, lausn inniheldur 10 mg brivaracetam.
English: In juvenile dogs, the brivaracetam-induced changes at the exposure level 6- fold the clinical AUC were similar to those observed in adult animals.
Icelandic: AUC útsetning brivaracetams til breytinga sem voru svipaðar og í fullorðnum dýrum.
English: For a dose of 4 mg/kg/day
Icelandic: Skammtur sem nemur 4 mg/kg/dag
English: Briviact 75 mg film-coated tablets brivaracetam
Icelandic: Briviact 75 mg filmuhúðaðar töflur brivaracetam
English: EU/1/15/1073/004 168 (3 packs of 56) film-coated tablets
Icelandic: EU/1/15/1073/004 168 (3 pakkningar með 56) filmuhúðaðar töflur
English: The efficacy of brivaracetam in monotherapy has not been established.
Icelandic: Ekki hefur verið sýnt fram á verkun brivaracetams sem einlyfja meðferð.
English: 0.2 ml/kg/intake
Icelandic: 0,2 ml/kg/gjöf
English: Diluents - Sodium chloride 9 mg/ml (0.9 %) solution for injection - Glucose 50 mg/ml (5 %) solution for injection - Lactated Ringer's solution for injection.
Icelandic: - Natríumklóríð 9 mg/ml (0,9%) stungulyf, lausn
English: EU/1/15/1073/013 14 film-coated tablets EU/1/15/1073/014 56 film-coated tablets EU/1/15/1073/015 100 x 1 film-coated tablet EU/1/15/1073/026 14 x 1 film-coated tablet
Icelandic: EU/1/15/1073/013 14 filmuhúðaðar töflur EU/1/15/1073/014 56 filmuhúðaðar töflur EU/1/15/1073/015100 x 1 filmuhúðuð tafla EU/1/15/1073/026 14 x 1 filmuhúðuð tafla
English: - 75 mg film-coated tablets: polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc, iron oxide yellow (E172), iron oxide red (E172), iron oxide black (E172).
Icelandic: - 75 mg filmuhúðaðar töflur: pólývínýl alkóhól, títan tvíoxíð (E171), makrógól 3350, talkúm, gult járnoxíð (E172), rautt járnoxíð (E172), svart járnoxíð (E172).
English: Briviact 10mg/ml solution for injection/infusion brivaracetam
Icelandic: Briviact 10 mg/ml stungulyf/innrennslislyf, lausn brivaracetam
English: Briviact 25 mg film-coated tablets brivaracetam
Icelandic: Briviact 25 mg filmuhúðaðar töflur brivaracetam
English: People with liver problems If you have problems with your liver: - As an adult, adolescent or child weighing 50 kg or more, the maximum dose you will take is 75 mg twice a day.
Icelandic: Ef þú ert fullorðinn, unglingur eða barn og vegur 50 kg eða meira er hámarksskammturinn sem þú tekur 75 mg tvisvar sinnum á dag.
English: There is no specific antidote for overdose with brivaracetam.
Icelandic: Ekkert sértækt mótefni er til við ofskömmtun brivaracetams.
English: The 5 ml oral syringe has 2 overlapping graduations: in steps of 0.25 ml and in steps of 0.1 ml.
Icelandic: á öðrum táknar hvert strik 0,25 ml skammt og á hinum 0,1 ml.
English: EU/1/15/1073/009 14 film-coated tablets EU/1/15/1073/010 56 film-coated tablets EU/1/15/1073/011 100 x 1 film-coated tablet EU/1/15/1073/025 14 x 1 film-coated tablet
Icelandic: EU/1/15/1073/009 14 filmuhúðaðar töflur EU/1/15/1073/010 56 filmuhúðaðar töflur EU/1/15/1073/011 100 x 1 filmuhúðuð tafla EU/1/15/1073/025 14 x 1 filmuhúðuð tafla
English: Other strong enzyme inducers (such as St John´s wort (Hypericum perforatum)) may also decrease the systemic exposure of brivaracetam.
Icelandic: Einnig má búast við minni altækri útsetningu fyrir brivaracetami með öðrum öflugum ensím‑virkjum (svo sem jóhannesarjurt (Hypericum perforatum)).
English: Briviact 10 mg film-coated tablets brivaracetam
Icelandic: Briviact 10 mg filmuhúðaðar töflur brivaracetam
English: EU/1/15/1073/008 168 (3 packs of 56) film-coated tablets
Icelandic: EU/1/15/1073/008 168 (3 pakkningar með 56) filmuhúðaðar töflur
English: - 100 mg film-coated tablets: polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc, iron oxide yellow (E172), iron oxide black (E172).
Icelandic: - 100 mg filmuhúðaðar töflur: pólývínýl alkóhól, títan tvíoxíð (E171), makrógól 3350, talkúm, gult járnoxíð (E172), svart járnoxíð (E172).
English: Briviact 100 mg film-coated tablets brivaracetam
Icelandic: Briviact 100 mg filmuhúðaðar töflur brivaracetam
English: EU/1/15/1073/020 168 (3 packs of 56) film-coated tablets
Icelandic: EU/1/15/1073/020 168 (3 pakkningar með 56) filmuhúðaðar töflur
English: EU/1/15/1073/005 14 film-coated tablets EU/1/15/1073/006 56 film-coated tablets EU/1/15/1073/007 100 x 1 film-coated tablet EU/1/15/1073/024 14 x 1 film-coated tablet
Icelandic: EU/1/15/1073/005 14 filmuhúðaðar töflur EU/1/15/1073/006 56 filmuhúðaðar töflur EU/1/15/1073/007 100 x 1 filmuhúðuð tafla EU/1/15/1073/024 14 x 1 filmuhúðuð tafla
English: EU/1/15/1073/001 14 film-coated tablets EU/1/15/1073/002 56 film-coated tablets EU/1/15/1073/003 100 x 1 film-coated tablet EU/1/15/1073/023 14 x 1 film-coated tablet
Icelandic: EU/1/15/1073/001 14 filmuhúðaðar töflur EU/1/15/1073/002 56 filmuhúðaðar töflur EU/1/15/1073/003 100 x 1 filmuhúðuð tafla EU/1/15/1073/023 14 x 1 filmuhúðuð tafla
English: INSTRUCTIONS ON USE
Icelandic: Ráðlagður viðhaldsskammtur
English: Lactose anhydrous Magnesium stearate
Icelandic: Flogaveikilyf sem eru öflugir ensím‑virkjar
English: EU/1/15/1073/016 168 (3 packs of 56) film-coated tablets
Icelandic: EU/1/15/1073/016 168 (3 pakkningar með 56) filmuhúðaðar töflur
English: EU/1/15/1073/012 168 (3 packs of 56) film-coated tablets
Icelandic: EU/1/15/1073/012 168 (3 pakkningar með 56) filmuhúðaðar töflur
English: INFORMATION IN BRAILLE
Icelandic: Upplýsingar um Briviact
English: - 50 mg film-coated tablets: polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc, iron oxide yellow (E172), iron oxide red (E172).
Icelandic: - 50 mg filmuhúðaðar töflur: pólývínýl alkóhól, títan tvíoxíð (E171), makrógól 3350, talkúm, gult járnoxíð (E172), rautt járnoxíð (E172).
English: - 25 mg film-coated tablets: polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc, iron oxide yellow (E172), iron oxide black (E172).
Icelandic: - 25 mg filmuhúðaðar töflur: pólývínýl alkóhól, títan tvíoxíð (E171), makrógól 3350, talkúm, gult járnoxíð (E172), svart járnoxíð (E172).
English: nervous excitement (agitation) - thoughts or attempts of harming or killing yourself: tell your doctor straight away
Icelandic: - hugsanir eða tilraunir til að valda sér skaða eða stytta sér aldur.
English: A nasogastric tube or a gastrostomy tube may be used when administering brivaracetam oral solution.
Icelandic: Nota má magaslöngu um nasir eða slöngu um magarauf við gjöf brivaracetam mixtúru, lausnar.
English: Briviact 50 mg tablets brivaracetam
Icelandic: 50 mg töflur brivaracetam
English: Concomitant treatment with levetiracetam
Icelandic: Samhliðameðferð með levetiracetami
English: Table 1: Pharmacokinetic interactions between brivaracetam and other AEDs AED coadministered Influence of AED on brivaracetam plasma concentration
Icelandic: Milliverkanir lyfjahvarfa brivaracetams og annarra flogaveikilyfja Flogaveikilyf gefin samhliða
English: VIAL
Icelandic: Töflukjarni
English: Briviact 10 mg/ml oral solution
Icelandic: Briviact 10 mg/ml mixtúra, lausn
English: - Intravenous bolus: brivaracetam may be administered as an intravenous bolus without dilution.
Icelandic: Brivaracetam má gefa sem inndælingu í bláæð án þynningar.
English: Convulsion, vertigo
Icelandic: Sundl, svefnhöfgi
English: 5260 Odense S, Denmark
Icelandic: 5260 Odense S, Danmörk
English: 9/l); requirement for clopidogrel or oral anticoagulants (OAC); or intolerance to any of the two compounds.
Icelandic: 9/l); þörf fyrir klópídógrel eða segavarnarlyf til inntöku (oral anticoagulants (OAC));eða óþol fyrir öðru hvoru þessara tveggja efna.
English: Some other medicines may influence the use of Grepid or vice versa.
Icelandic: Sum önnur lyf geta haft áhrif á notkun Grepid og öfugt.
English: This leaflet was last revised in <Month YYYY>.
Icelandic: Þessi fylgiseðill var síðast uppfærður í <mánuður ÁÁÁÁ>.
English: You should take Grepid for as long as your doctor continues to prescribe it.
Icelandic: Þú skalt taka Grepid meðan læknirinn heldur áfram að ávísa því.
English: What Grepid is and what it is used for
Icelandic: Upplýsingar um Grepid og við hverju það er notað
English: An occasional use of acetylsalicylic acid (not more than 1,000 mg in 24 hour period) should generally not cause a problem, but prolonged use in other circumstances should be discussed with your doctor.
Icelandic: Notkun acetýlsalicýlsýru öðru hverju (ekki meira en 1.000 mg á sólarhring) ætti almennt ekki að valda vandræðum en langvarandi notkun við aðrar aðstæður á að ræða við lækninn.
English: The most common side effect reported with Grepid is bleeding.
Icelandic: Algengasta aukaverkunin sem tilkynnt hefur verið um vegna Grepid er blæðingar.
English: Very rare, not known*
Icelandic: Koma örsjaldan fyrir , tíðni ekki þekkt*
English: If you forget to take Grepid
Icelandic: Ef gleymist að taka Grepid
English: If HPR ≥ 46 units, the patients were escalated back to prasugrel 5 or 10 mg/d for 11.5 months; if HPR < 46 units, the patients continued on clopidogrel 75 mg/d for 11.5 months.
Icelandic: Ef HPR var ≥46 einingar var sjúklingnum aftur látinn fá prasugrel 5 eða 10 mg/sólarhring í 11,5 mánuði; ef HPR var<46 einingar hélt sjúklingurinn áfram á klópídógreli 75 mg/sólarhring í 11,5 mánuði.
English: Date of first authorisation: 28 July 2009 Date of latest renewal: 11 April 2014
Icelandic: 28 júlí 2009 Nýjasta dagsetning endurnýjunar markaðsleyfis:
English: - The active substance is clopidogrel.
Icelandic: - Virka innihaldsefnið er klópídógrel.
English: Thrombotic Thrombocytopenic Purpura (TTP)
Icelandic: Blóðflagnafæðar Sega-blóðflögufæðarpurpuri (Thrombotic Thrombocytopenic Purpura (TTP))
English: Marketing Authorisation Holder and Manufacturer
Icelandic: Markaðsleyfishafi og framleiðendur
English: If you have experienced severe chest pain (unstable angina or heart attack), your doctor may give you 300 mg of Grepid (4 tablets of 75 mg) once at the start of treatment.
Icelandic: Ef þú hefur fundið fyrir verulegum verk fyrir brjósti (hvikul hjartaöng eða hjartaáfall) getur verið að læknirinn gefi þér 300 mg af Grepid (fjórar 75 mg töflur) í eitt skipti við upphaf meðferðar.
English: Grepid film-coated tablets are pink, round and biconvex.
Icelandic: Grepid filmuhúðaðar töflur eru bleikar, kringlóttar og tvíkúptar.
English: If you forget to take a dose of Grepid, but remember within 12 hours of your usual time, take your tablet straightaway and then take your next tablet at the usual time.
Icelandic: Ef þú gleymir að taka Grepid, en manst eftir því innan 12 klst. frá venjulegum inntökutíma, skaltu taka töfluna strax og síðan næstu töflu á venjulegum tíma.
English: Platelets are very small structures in the blood which clump together during blood clotting.
Icelandic: Blóðflögur eru mjög smáar agnir í blóðinu,sem festast saman við blóðstorknun.
English: Medicinal products that are strong or moderate CYP2C19 inhibitors include, for example, omeprazole and esomeprazole, fluvoxamine, fluoxetine, moclobemide, voriconazole, fluconazole, ticlopidine, carbamazepine, and efavirenz.
Icelandic: Lyf sem eru öflugir eða meðallagi öflugir hemlar á CYP2C19 eru t.d. omeprazol og esomeprazol, fluvoxamin, fluoxetin, moclobemid, voriconazol, fluconazol, ticlopidin, carbameazepin, og efavirenz
English: Film-coating Hypromellose (E464) Iron oxide red (E172) Lactose monohydrate Triacetin (E1518) Titanium dioxide (E171)
Icelandic: Hýprómellósi (E464) Rautt járnoxíð (E172) Laktósaeinhýdrat Tríacetín (E1518) Títantvíoxíð (E171)
English: If you become pregnant while taking Grepid, consult your doctor immediately as it is recommended not to take Grepid while you are pregnant.
Icelandic: Ef þú verður barnshafandi á meðan þú tekur Grepid skaltu tafarlaust ráðfæra þig við lækninn, því það er ekki ráðlegt að taka inn Grepid á meðgöngu.
English: If you experience prolonged bleeding when taking Grepid If you cut or injure yourself, it may take longer than usual for bleeding to stop.
Icelandic: Ef blæðing heldur áfram þegar þú tekur Grepid Ef þú skerð þig eða slasar, gæti blæðingin verið lengur en venjulega að stöðvast.
English: However, if you are concerned by your bleeding, you should contact your doctor straightaway (see ‘Warnings and precautions').
Icelandic: Ef þú hefur hins vegar áhyggjur af blæðingunni skalt þú strax hafa samband við lækninn (sjá kafla 2 „Varnaðarorð og varúðarreglur“).
English: The primary endpoint (the combined incidence of CV death, MI, stroke and BARC bleeding grade ≥ 2 at 12 months) was met showing non-inferiority.
Icelandic: Aðalendapunktinum (sameinuð tíðni dauðsfalla af völdum hjarta- og æðasjúkdóma, hjartadreps, slags og BARC blæðinga stig ≥2 eftir 12 mánuði) var náð og sýndi að áhrifin voru ekki lakari.
English: Each film-coated tablet contains 2.47 mg of lactose (as monohydrate).
Icelandic: Hver filmuhúðuð tafla inniheldur 2,47mg af laktósa (sem einhýdrat).
English: Your doctor should have prescribed Grepid plus acetylsalicylic acid if you cannot take ‘oral anticoagulants' and you do not have a risk of major bleeding.
Icelandic: Læknirinn ætti að hafa ávísað þér Grepid og acetýlsalicýlsýru ef þú getur ekki tekið blóðþynningarlyf og ef þú ert ekki í hættu á að fá miklar blæðingar.
English: Store below 25°C (for PVC/PE/PVDC/aluminium blisters) Or
Icelandic: Geymið við lægri hita en 25°C (á við PVC/PE/PVDC/álþynnupakkningar)
English: 15351 Pallini Attiki Greece
Icelandic: 15351 Pallini Attiki Grikkland eða
English: As a precautionary measure, breast-feeding should not be continued during treatment with Grepid.
Icelandic: Sem varúðarráðstöfun á ekki að halda áfram brjóstagjöf meðan á Grepid meðferð stendur.
English: Their frequency is defined using the following conventions: common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000), not known (cannot be estimated from the available data).
Icelandic: Algengar (≥ 1/100 til <1/10); sjaldgæfar (≥ 1/1.000 til <1/100); mjög sjaldgæfar (≥ 1/10.000 til <1/1.000);, Koma örsjaldan fyrir (<1/10.000), tíðni ekki þekkt (ekki hægt að áætla tíðni út frá fyrirliggjandi gögnum).
English: The recommended dose, including for patients with a condition called ‘atrial fibrillation' (an irregular heartbeat), is one 75 mg tablet of Grepid per day to be taken orally with or without food, and at the same time each day.
Icelandic: Ráðlagður skammtur, einnig fyrir sjúklinga með gáttatif (óreglulegur hjartsláttur), er ein 75 mg tafla af Grepid á sólarhring, til inntöku með eða án matar, á sama tíma dag hvern.
English: Follow-up at one year was performed for 316 patients (98.1 %) in the de-escalated DAPT group and 318 patients (98.5 %) in the unchanged DAPT group.
Icelandic: Eftirfylgni var með 316 sjúklingum í eitt ár (98,1%) hjá (de-escalated) DAPT hópnum og 318 sjúklingum (98,5%) sem fengu óbreytt DAPT.
English: Animal studies have shown excretion of clopidogrel in breast milk.
Icelandic: Rannsóknir á dýrum hafa sýnt að klópídógrel skilst út í móðurmjólk.
English: If you have experienced severe chest pain (unstable angina or heart attack), you may be prescribed Grepid in combination with acetylsalicylic acid, a substance present in many medicines used to relieve pain and lower fever.
Icelandic: Ef þú hefur fundið fyrir verulegum verk fyrir brjósti (hvikul hjartaöng eða hjartaáfall) gætir þú fengið ávísað Grepid ásamt acetýlsalicýlsýru, efni sem er í mörgum lyfjum til þess að stilla verki og lækka hita.
English: Serum sickness, anaphylactoid reactions, cross-reactive drug hypersensitivity among thienopyridines (such as ticlopidine, prasugrel) (see section 4.4)*, insulin autoimmune syndrome, which can lead to severe hypoglycemia, particularly in patients with HLA DRA4 subtype (more frequent in the Japanese
Icelandic: Sermissótt, bráðaofnæmislík viðbrögð, kross-ofnæmi meðal tíenópýridína (svo sem ticlopidin, prasugrel) (sjá kafla 4.4)*, heilkenni mótefnatengdrar sykursýki sem getur valdið verulegri blóðsykurslækkun, einkum hjá sjúklingum með HLA DRA4 undirflokk (algengara hjá Japönum)*
English: Grepid contains lactose.
Icelandic: Grepid inniheldur laktósa.
English: In patients who remained on therapy within five days of bypass graft surgery, the event rate was 9.6 % for clopidogrel plus ASA, and 6.3 % for placebo plus ASA.
Icelandic: Hjá sjúklingum sem voru ennþá á meðferð innan fimm daga fyrir hjáveituaðgerðina, var tíðni þessara aukaverkana 9,6% fyrir klópídógrel ásamt acetýlsalicýlsýru og 6,3% fyrir lyfleysu ásamt acetýlsalicýlsýru.
English: What Grepid is and what it is used for What you need to know before you take Grepid How to take Grepid
Icelandic: Í fylgiseðlinum eru eftirfarandi kaflar Upplýsingar um Grepid og við hverju það er notað Áður en byrjað er að nota Grepid Hvernig nota á Grepid
English: Bleeding events defined as all BARC occurred in 30 patients (9.3 %) in the de-escalated DAPT group and in 76 patients (23.5 %) in the unchanged DAPT group (p<0.01).
Icelandic: Blæðingartilvik skilgreind sem öll BARC sem kom fram hjá 30 sjúklingum (9,3%) hjá (de-escalated) DAPT hópnum og hjá 76 sjúklingum (23,5%) sem fengu óbreytt DAPT (p<0,01).
English: EU/1/09/535/001 14 Film-coated tablets blister (PVC/PE/PVDC/alu) EU/1/09/535/002 28 Film-coated tablets blister (PVC/PE/PVDC/alu) EU/1/09/535/003 30 Film-coated tablets blister (PVC/PE/PVDC/alu) EU/1/09/535/004 50 Film-coated tablets blister (PVC/PE/PVDC/alu) EU/1/09/535/005 84 Film-coated tablets blister (PVC/PE/PVDC/alu) EU/1/09/535/006 90 Film-coated tablets blister (PVC/PE/PVDC/alu) EU/1/09/535/007 100 Film-coated tablets blister (PVC/PE/PVDC/alu) EU/1/09/535/008 14 Film-coated tablets blister (alu/alu) EU/1/09/535/009 28 Film-coated tablets blister (alu/alu) EU/1/09/535/010 30 Film-coated tablets blister (alu/alu) EU/1/09/535/011 50 Film-coated tablets blister (alu/alu) EU/1/09/535/012 84 Film-coated tablets blister (alu/alu) EU/1/09/535/013 90 Film-coated tablets blister (alu/alu) EU/1/09/535/014 100 Film-coated tablets blister (alu/alu) EU/1/09/535/015 10 Film-coated tablets blister (PVC/PE/PVDC/alu) EU/1/09/535/016 28 Film-coated tablets blister (PVC/PE/PVDC/alu), calendar
Icelandic: Hvítar (alu/alu) EU/1/09/535/013 90 filmuhúðuðum töflum Hvítar (alu/alu) EU/1/09/535/014 100 filmuhúðuðum töflum Hvítar (alu/alu) EU/1/09/535/015 10 filmuhúðuðum töflum Hvítar (PVC/PE/PVDC/alu) EU/1/09/535/016 28 filmuhúðuðum töflum Hvítar (PVC/PE/PVDC/alu),
English: Symphar Sp. z o.o.
Icelandic: Symphar Sp.
English: In contrast, post-hoc analyses demonstrated statistically significant increases in the bleeding risk with the more potent P2Y12 inhibitors, occurring predominantly during the maintenance phase, after the first month postACS.
Icelandic: Aftur á móti sýndi eftirágreiningar tölfræðilega marktæka aukningu á blæðingarhættu með öflugari P2Y12 hemlunum aðallega í viðhaldsfasanum fyrstu mánuðina eftir brátt kransæðaheilkenni.
English: If Grepid is supplied in PVC/PE/PVDC/aluminium blisters, store below 25°C.
Icelandic: Ef Grepid er í PVC/PE/PVDC/álpynnupakkningu á að geyma lyfið við lægri hita en 25°C.
English: 4.7 Effects on ability to drive and use machines
Icelandic: Áhrif á hæfni til aksturs og notkunar véla
English: Grepid contains lactose
Icelandic: Grepid inniheldur mjólkursykur