FrancophonIA/ELRC3.0 huggingface dataset:
English: Clopidogrel/Acetylsalicylic acid Mylan 75 mg/100 mg film-coated tablets are pink, oval-shaped biconvex, tablets imprinted with CA3 on one side of the tablet and M on the other side.
Icelandic: Clopidogrel/Acetylsalicylic acid Mylan 75 mg/100 mg filmuhúðaðar töflur eru bleikar, sporöskjulaga tvíkúptar töflur, með „CA3“ greipt í aðra hliðina og „M“ í hina.
English: Each tablet contains 75 mg of clopidogrel (as hydrogen sulphate) and 75 mg of acetylsalicylic acid.
Icelandic: Hver tafla inniheldur 75 mg af klópídógreli (sem hýdrógensúlfat) og 75 mg af acetýlsalicýlsýru.
English: EU/1/19/1395/001 - 28 film coated tablets in aluminium blister packs EU/1/19/1395/002 - 30 film coated tablets in aluminium blister packs EU/1/19/1395/003 - 28 x 1 (unit dose) film coated tablets in aluminium blister packs EU/1/19/1395/004 - 30 x 1 (unit dose) film coated tablets in aluminium blister packs EU/1/19/1395/005 - 100 film coated tablets in HDPE bottle packs
Icelandic: EU/1/19/1395/001 - 28 filmuhúðaðar töflur í álþynnupakkningum EU/1/19/1395/002 - 30 filmuhúðaðar töflur í álþynnupakkningum EU/1/19/1395/003 - 28 × 1 (stakskammtur) filmuhúðaðar töflur í álþynnupakkningum EU/1/19/1395/004 - 30 × 1 (stakskammtur) filmuhúðaðar töflur í álþynnupakkningum EU/1/19/1395/005 - 100 filmuhúðaðar töflur í HDPE-glösum
English: EU/1/19/1395/006 - 28 film coated tablets in aluminium blister packs EU/1/19/1395/007 - 30 film coated tablets in aluminium blister packs EU/1/19/1395/008 - 28 x 1 (unit dose) film coated tablets in aluminium blister packs EU/1/19/1395/009 - 30 x 1 (unit dose) film coated tablets in aluminium blister packs EU/1/19/1395/010 - 100 film coated tablets in HDPE bottle packs
Icelandic: EU/1/19/1395/006 - 28 filmuhúðaðar töflur í álþynnupakkningum EU/1/19/1395/007 - 30 filmuhúðaðar töflur í álþynnupakkningum EU/1/19/1395/008 - 28 × 1 (stakskammtur) filmuhúðaðar töflur í álþynnupakkningum EU/1/19/1395/009 - 30 × 1 (stakskammtur) filmuhúðaðar töflur í álþynnupakkningum EU/1/19/1395/010 - 100 filmuhúðaðar töflur í HDPE-glösum
English: Gastrointestinal haemorrhage, diarrhoea, abdominal pain, dyspepsia
Icelandic: Niðurgangur, kviðverkir, meltingartruflanir og brjóstsviði.
English: Mean peak plasma levels of unchanged clopidogrel (approximately 2.2-2.5 ng/ml after a single 75 mg oral dose) occurred approximately 45 minutes after dosing.
Icelandic: Meðalhámarksþéttni óbreytts klópídógrels í plasma (u.þ.b. 2,2 - 2,5 ng/ml eftir stakan 75 mg skammt til inntöku) náðist u.þ.b.
English: Clopidogrel/Acetylsalicylic acid Mylan 75 mg/75 mg film-coated tablets Clopidogrel/Acetylsalicylic acid Mylan 75 mg/100 mg film-coated tablets clopidogrel/acetylsalicylic acid
Icelandic: Clopidogrel/Acetylsalicylic acid Mylan 75 mg/75 mg filmuhúðaðar töflur Clopidogrel/Acetylsalicylic acid Mylan 75 mg/100 mg filmuhúðaðar töflur klópídógrel / acetýlsalicýlsýra
English: Each tablet contains 75 mg of clopidogrel (as hydrogen sulphate) and 100 mg of acetylsalicylic acid.
Icelandic: Hver tafla inniheldur 75 mg af klópídógreli (sem hýdrógensúlfat) og 100 mg af acetýlsalicýlsýru.
English: Acetazolamide
Icelandic: A. ÁLETRANIR
English: Contains lactose and Allura Red AC. See leaflet for further information.
Icelandic: Inniheldur laktósa og allúrarautt AC.
English: Upper gastrointestinal disorders (oesophagitis, oesophageal ulceration, perforation, erosive gastritis, erosive duodenitis; gastroduodenal ulcer/perforations)*; lower gastrointestinal disorders (small [jejunum and ileum] and large [colon and rectum] intestinal ulcers, colitis and intestinal perforation)*; upper gastro-intestinal symptoms* such as gastralgia (see section 4.4); these ASA related GI reactions may or may not be associated with haemorrhage, and may occur at any dose of acetylsalicylic acid and in patients with or without warning symptoms or a previous history of serious GI events*.
Icelandic: *; einkenni frá efri hluta meltingarvegar eins og t.d. magaverkur (sjá kafla 4.4); þessum aukaverkunum í meltingarvegi sem eru vegna acetýlsalicýlsýru getur ýmist fylgt blæðing eða ekki, og þær geta komið fyrir við hvaða skammt af acetýlsalicýlsýru sem er og hjá sjúklingum með eða án viðvörunareinkenna eða fyrri sögu um alvarlega sjúkdóma í meltingarvegi Ristilbólga (þar með talin sáraristilbólga og eitilfrumuristilbólga), munnbólga, bráð brisbólga í tengslum við ofnæmisviðbrögð vegna acetýlsalicýlsýru
English: By preventing this clumping in some types of blood vessels (called arteries), antiplatelet medicinal products reduce the chances of blood clots forming (a process called atherothrombosis).
Icelandic: Lyf sem hindra samloðun blóðflagna minnka hættuna á myndun blóðkekkja (ferli sem nefnist segamyndun) með því að koma í veg fyrir þessa samloðun í tilteknum æðum (slagæðum).
English: Clopidogrel/Acetylsalicylic acid Mylan 75 mg/100 mg film-coated tablets Clopidogrel/Acetylsalicylic acid Mylan should be given as a single daily 75 mg/100 mg dose
Icelandic: Clopidogrel/Acetylsalicylic acid Mylan 75 mg/100 mg filmuhúðaðar töflur Clopidogrel/Acetylsalicylic acid á að gefa í einum daglegum 75 mg/100 mg skammti.
English: Clopidogrel/Acetylsalicylic acid Mylan 75 mg/75 mg film-coated tablet The active substances are clopidogrel and acetylsalicylic acid.
Icelandic: Clopidogrel/Acetylsalicylic acid Mylan 75 mg/75 mg filmuhúðuð tafla Virku innihaldsefnin eru klópídógrel og acetýlsalicýlsýra.
English: Until the 24
Icelandic: Því næst verður
English: Each film-coated tablet contains 75 mg clopidogrel (as hydrogen sulphate) and 75 mg acetylsalicylic acid.
Icelandic: Hver filmuhúðuð tafla inniheldur 75 mg af klópídógreli (sem hýdrógensúlfat) og 75 mg af acetýlsalicýlsýru.
English: Clopidogrel/Acetylsalicylic acid Mylan 75 mg/75 mg film-coated tablets Clopidogrel/Acetylsalicylic acid Mylan 75 mg/100 mg film-coated tablets
Icelandic: Clopidogrel/Acetylsalicylic acid Mylan 75 mg/75 mg filmuhúðaðar töflur Clopidogrel/Acetylsalicylic acid Mylan 75 mg/100 mg filmuhúðaðar töflur
English: Haematuria
Icelandic: Töflukjarni
English: Valproic acid
Icelandic: Segaleysandi lyf
English: Each film-coated tablet contains 75 mg clopidogrel (as hydrogen sulphate) and 100 mg acetylsalicylic acid
Icelandic: Hver filmuhúðuð tafla inniheldur 75 mg af klópídógreli (sem hýdrógensúlfat) og 100 mg af acetýlsalicýlsýru
English: Clopidogrel/Acetylsalicylic acid Mylan 75 mg/100 mg film-coated tablet The active substances are clopidogrel and acetylsalicylic acid.
Icelandic: Clopidogrel/Acetylsalicylic acid Mylan 75 mg/100 mg filmuhúðuð tafla Virku innihaldsefnin eru klópídógrel og acetýlsalicýlsýra.
English: Gastrointestinal (GI)
Icelandic: Bólgueyðandi gigtarlyf (NSAID)
English: While you are taking Clopidogrel/Acetylsalicylic acid Mylan
Icelandic: Meðan á meðferð með Clopidogrel/Acetylsalicylic acid Mylan stendur
English: Retroperitoneal haemorrhage
Icelandic: Örkristallaður sellulósi Laktósi
English: What Clopidogrel/Acetylsalicylic acid Mylan contains
Icelandic: Clopidogrel/Acetylsalicylic acid Mylan inniheldur
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING
Icelandic: Samantekt á aukaverkunum, sett upp í töflu
English: Reproductive systems and breast disorders
Icelandic: Meðganga og brjóstagjöf
English: Clopidogrel/Acetylsalicylic acid Mylan 75 mg/75 mg film-coated tablets are yellow, oval shaped biconvex tablets imprinted with CA2 on one side of the tablet and M on the other side.
Icelandic: Clopidogrel/Acetylsalicylic acid Mylan 75 mg/75 mg filmuhúðaðar töflur eru gular, sporöskjulaga tvíkúptar töflur, með „CA2“ greipt í aðra hliðina og „M“ í hina.
English: • ST segment elevation acute myocardial infarction in medically treated patients eligible for thrombolytic therapy
Icelandic: Brátt hjartadrep með ST-hækkun hjá sjúklingum sem eru í lyfjameðferð og uppfylla skilyrði segaleysandi meðferðar
English: No substantial differences in active metabolite exposure and mean inhibition of platelet aggregation (IPA) were observed between ultra-rapid, extensive and intermediate metabolisers.
Icelandic: Enginn verulegur munur kom fram á útsetningu fyrir virka umbrotsefninu og meðalhömlun á samloðun blóðflagna (IPA) hjá mismunandi hópum einstaklinga með ofurhratt, verulegt, í meðallagi og lélegt CYP2C19 umbrot.
English: Due to the presence of both components of the medicinal product, Clopidogrel/Acetylsalicylic acid Mylan is contraindicated in case of:
Icelandic: Á grundvelli beggja virku efnanna í lyfinu má ekki nota Clopidogrel/Acetylsalicylic acid Mylan þegar um er að ræða:
English: The bottles contain a desiccant.
Icelandic: Á pakkningunni er tvívítt strikamerki með einkvæmu auðkenni.
English: Clopidogrel/Acetylsalicylic acid Mylan 75 mg/75 mg film-coated tablets clopidogrel/acetylsalicylic acid
Icelandic: Clopidogrel/Acetylsalicylic acid Mylan 75 mg/75 mg filmuhúðaðar töflur klópídógrel / acetýlsalicýlsýra
English: GENERAL CLASSIFICATION FOR SUPPLY
Icelandic: Segavarnarlyf til inntöku
English: Clopidogrel/Acetylsalicylic acid Mylan 75 mg/75 mg tablets
Icelandic: Clopidogrel/Acetylsalicylic acid Mylan 75 mg/75 mg töflur
English: Based on the pharmacokinetic and metabolic characteristics of both compounds, clinically significant PK interactions are unlikely.
Icelandic: Byggt á lyfjahvörfum og eiginleikum beggja efnanna, eru klínískt marktækar lyfjahvarfamilliverkanir ólíklegar.
English: Thrombolytics
Icelandic: 13. LOTUNÚMER
English: Clopidogrel/Acetylsalicylic acid Mylan 75 mg/100 mg tablets
Icelandic: Clopidogrel/Acetylsalicylic acid Mylan 75 mg/100 mg töflur
English: • opioids: while you are treated with clopidogrel, you should inform your doctor before being prescribed any opioids treatment.
Icelandic: Ef óþol fyrir sykrum hefur verið staðfest, skal hafa samband við lækni áður en lyfið er tekið inn.
English: Clopidogrel/Acetylsalicylic acid Mylan 75 mg/100 mg film-coated tablets clopidogrel/acetylsalicylic acid
Icelandic: Clopidogrel/Acetylsalicylic acid Mylan 75 mg/100 mg filmuhúðaðar töflur klópídógrel / acetýlsalicýlsýra
English: Clopidogrel/Acetylsalicylic acid Mylan 75 mg/75 mg film-coated tablets Hypromellose
Icelandic: Clopidogrel/Acetylsalicylic acid Mylan 75 mg/75 mg filmuhúðaðar töflur Hýprómellósi
English: How to take Clopidogrel/Acetylsalicylic acid Mylan
Icelandic: Ekki má nota Clopidogrel/Acetylsalicylic acid Mylan
English: Clopidogrel/Acetylsalicylic acid Mylan 75 mg/100 mg film-coated tablets Hypromellose
Icelandic: Clopidogrel/Acetylsalicylic acid Mylan 75 mg/100 mg filmuhúðaðar töflur Hýprómellósi
English: Thrombocytopenia, leucopenia, eosinophilia
Icelandic: Hert laxerolía Sterkja, forhleypt Sterínsýra
English: Furthermore, the pharmacodynamic activity of clopidogrel was not significantly influenced by the co-administration of phenobarbital or oestrogen.
Icelandic: Ennfremur kom fram að gjöf fenóbarbítals eða estrógens samhliða klópídógreli, hafði ekki marktæk áhrif á lyfhrif klópídógrels.
English: Clopidogrel/Acetylsalicylic acid Mylan 75 mg/100 mg film-coated tablets EU/1/19/1395/006 - Cartons of 28 film coated tablets in aluminium blister packs EU/1/19/1395/007 - Cartons of 30 film coated tablets in aluminium blister packs EU/1/19/1395/008 - Cartons of 28 x 1 (unit dose) film coated tablets in aluminium blister packs EU/1/19/1395/009 - Cartons of 30 x 1 (unit dose) film coated tablets in aluminium blister packs EU/1/19/1395/010 - Cartons of 100 film coated tablets in HDPE bottle packs
Icelandic: - Öskjur með 28 filmuhúðuðum töflum í álþynnupakkningum EU/1/19/1395/007 - Öskjur með 30 filmuhúðuðum töflum í álþynnupakkningum EU/1/19/1395/008 - Öskjur með 28 × 1 (stakskammtur) filmuhúðuðum töflum í álþynnupakkningum EU/1/19/1395/009 - Öskjur með 30 × 1 (stakskammtur) filmuhúðuðum töflum í álþynnupakkning
English: What Clopidogrel/Acetylsalicylic acid Mylan looks like and contents of the pack
Icelandic: Lýsing á útliti Clopidogrel/Acetylsalicylic acid Mylan og pakkningastærðir
English: Haematoma
Icelandic: Marblettir
English: • Hypersensitivity to non-steroidal anti-inflammatory drugs (NSAIDs) and syndrome of asthma, rhinitis, and nasal polyps.
Icelandic: þegar um er að ræða ofnæmi fyrir bólgueyðandi gigtarlyfjum (NSAID) og heilkenni astma, nefslímubólgu og nefbólgusepa.
English: There are no fertility data with clopidogrel/acetylsalicylic acid.
Icelandic: Engar upplýsingar liggja fyrir um áhrif klópídógrels/acetýlsalicýlsýru á frjósemi.
English: After a single oral dose of 75 mg, clopidogrel has a half-life of approximately 6 hours.
Icelandic: Helmingunartími brotthvarfs klópídógrels var u.þ.b. 6 klukkustundir eftir stakan 75 mg skammt til inntöku.
English: Number
Icelandic: Biðtími
English: ANNEX A
Icelandic: VIÐAUKI I
English: Adopted at the 11-14 January 2016 PRAC
Icelandic: Samþykkt á fundi PRAC 11.-14. janúar 2016
English: Frequencies are defined as: very common (≥ 1/10); 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).
Icelandic: Tíðnin er skilgreind á eftirfarandi hátt: mjög algengar (≥ 1/10); 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).
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom28 January 2016
Icelandic: 30 Churchill Place ● Canary Wharf ● London E14 5EU ●
English: Adverse reactions known to be associated with anticholinergic therapy, such as oxybutynin, are anorexia, vomiting, reflux oesophagitis, decreased sweating, heat stroke, decreased lacrimation, mydriasis, tachycardia, arrhythmia, disorientation, poor ability to concentrate, fatigue, nightmares, restlessness, convulsion, intraocular hypertension and induction of glaucoma, confusion, anxiety, paranoia, hallucination, photosensitivity, erectile dysfunction.
Icelandic: Aukaverkanir sem þekkt er að tengjast meðferð með andkólínvirkum lyfjum eins og oxýbútýníni, eru lystarleysi, uppköst, vélindabakflæði, minnkuð svitamyndun, hitaslag, minnkað táraflæði, ljósopstæring (mydriasis), hraðtaktur, takttruflun, vistarfirring, einbeitingarskortur, þreyta, martraðir, eirðarleysi, krampar, augnháþrýstingur og ræsing gláku (induction of glaucoma), ringlun, kvíði, vænisýki, ofskynjun, ljósnæmi, ristruflun.
English: The safety and efficacy of Kentera in the paediatric population has not been established.
Icelandic: Ekki hefur verið sýnt fram á öryggi og verkun Kentera hjá börnum.
English: KENTERA (oxybutynin) - Psychiatric disorders (EPITT no
Icelandic: KENTERA (oxybutynin) - Geðræn vandamál (EPITT no
English: There is no dose adjustment necessary in this population.
Icelandic: Engin þörf er á skammtaaðlögun fyrir þennan hóp.
English: Children may be more sensitive to the effects of the product, particularly the CNS and psychiatric adverse reactions.
Icelandic: Börn gætu verið næmari fyrir áhrifum lyfsins, einkum aukaverkunum af geðrænum toga og frá miðtaugakerfi.
English: There is no experience in children
Icelandic: Engin reynsla er af notkun lyfsins hjá börnum.
English: Adverse reactions from phase 3 and 4 clinical studies are listed below by system organ class and frequency grouping.
Icelandic: Aukaverkanir úr 3. og 4. stigs klínískum rannsóknum eru taldar upp hér fyrir neðan, flokkaðar eftir líffærum og tíðni:
English: # post-marketing adverse reactions from post-marketing reports only (not seen in clinical trials), with the frequency category estimated from clinical trial safety data, and reported in association with oxybutynin topical use (anticholinergic class effects).
Icelandic: # aukaverkanir tilkynntar eftir markaðssetningu (sáust ekki í klínískum rannsóknum), með tíðni áætlaða út frá gögnum úr klínískri öryggisrannsókn, og tilkynnt var um í tengslum við útvortis notkun oxýbútýníns (áhrif frá andkólínvirkum lyfjum).
English: Caution should be exercised when oxybutynin is administrated concomitantly with other anticholinergic medicines (see also section 4.5).
Icelandic: Gæta skal varúðar þegar oxýbútýnín er gefið samhliða öðrum andkólínvirkum lyfjum (sjá einnig kafla 4.5).
English: POSSIBLE SIDE EFFECTS
Icelandic: 4. HUGSANLEGAR AUKAVERKANIR
English: Applicable to all formulations: Kentera 3.9 mg / 24 hours transdermal patch, Kentera 90.7 mg/g gel in sachet and Kentera 90.7 mg/g gel in a metering pump
Icelandic: Kentera forðaplástur 3,9 mg / sólarhring, Kentera 90,7 mg/g hlaup í skammtapoka og Kentera 90,7 mg/g hlaup í mælipumpu
English: Anxiety, confusion, nervousness, agitation, insomnia
Icelandic: Kvíði, ringlun, taugaveiklun, æsingur, svefnleysi
English: Kentera is not recommended for use in the paediatric population.
Icelandic: Ekki er mælt með að nota Kentera hjá börnum.
English: Rare side effects: - panic reaction - mental confusion - hallucinations - disorientation - memory impairment - loss of memory - abnormal tiredness
Icelandic: Mjög sjaldgæfar aukaverkanir: - ofsahræðsla - óráð - ofskynjanir - vistarfirring - minnisskerðing - minnisleysi - óeðlileg þreyta - einbeitingarskortur
English: If a patient experiences such events, drug discontinuation should be considered.
Icelandic: Íhuga skal að hætta lyfjameðferð ef sjúklingur finnu fyrir slíkum aukaverkunum.
English: - anxiety - confusion - nervousness - agitation - difficulty in sleeping
Icelandic: - kvíði - ringlun - taugaveiklun - æsingur - svefnerfiðleikar
English: Postmarketing adverse reactions not seen in clinical trials are also included.
Icelandic: Aukaverkanir sem tilkynnt hefur verið um eftir markaðssetningu en komu ekki fram í klínískum rannsóknum eru einnig meðtaldar.
English: Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Icelandic: Innan hvers tíðniflokks eru alvarlegustu aukaverkanirnar taldar upp fyrst.
English: Kentera should be used with caution in elderly patients, who may be more sensitive to the effects of centrally acting anticholinergics and exhibit differences in pharmacokinetics (see section 4.4).
Icelandic: Gæta skal varúðar þegar Kentera er notað fyrir aldraða sjúklinga sem gætu verið næmari fyrir áhrifum andkólínvirkra lyfja sem verka á miðtaugakerfið og með breytt lyfjahvörf (sjá kafla 4.4).
English: Psychiatric and CNS anticholinergic events like sleep disorders (e.g. insomnia) and cognitive disorders have been associated with oxybutynin use, especially in elderly patients.
Icelandic: Andkólínergar aukaverkanir af geðrænum toga og frá miðtaugakerfi eins og vandamál með svefn (t.d. svefnleysi) og vitsmunaskerðing hafa verið tengdar notkun oxýbútýníns einkum hjá öldruðum sjúklingum.
English: Applicable to Kentera 3.9 mg / 24 hours transdermal patch only
Icelandic: Kentera forðaplástur 3,9 mg / sólarhring
English: […] Kentera should be used with caution in elderly patients, who may be more sensitive to the effects of centrally acting anticholinergics and exhibit differences in pharmacokinetics.
Icelandic: Gæta skal varúðar þegar Kentera er notað fyrir aldraða sjúklinga sem gætu verið næmari fyrir áhrifum andkólínvirkra lyfja sem verka á miðtaugakerfið og með breytt lyfjahvörf.
English: Other psychiatric events implying an anticholinergic mechanism have been reported during postmarketing use (see section 4.8).
Icelandic: Eftir markaðssetningu hefur verið tilkynnt um aðrar geðrænar aukaverkanir sem benda til andkólínergra áhrifa (sjá kafla 4.8).
English: Memory impairment#, amnesia#, lethargy#, disturbance in attention#
Icelandic: Minnisskerðing#, minnisleysi#, svefnhöfgi#, athyglisbrestur#
English: Panic reaction#, delirium#, hallucinations#, disorientation#
Icelandic: Ofsahræðsla#, óráð#, ofskynjanir#, vistarfirring#
English: During post-marketing use in this age group, cases of hallucinations (associated with anxiety manifestations) and sleep disorders correlated with oxybutynin have been reported.
Icelandic: Tilvik um ofskynjanir (í tengslum við kvíða) og svefnvandamál hafa verið tilkynnt í tengslum við notkun oxýbútýníns hjá börnum eftir markaðssetningu.
English: […] Paediatric population
Icelandic: […] Börn
English: Psychiatric disorders
Icelandic: Nýr texti fyrir lyfjaupplýsingar
English: General disorders and administration site conditions
Icelandic: Almennar aukaverkanir og aukaverkanir á íkomustað
English: Paediatric population
Icelandic: Tafla yfir aukaverkanir
English: Wash and dry your hands.
Icelandic: Þvoið og þurrkið hendurnar.
English: Talk to your doctor if you are not sure what to do.
Icelandic: Þú skalt ræða við lækninn ef þú er ekki viss um hvað eigi að gera.
English: Elderly (aged 65 years and over)
Icelandic: Aldraðir (65 ára og eldri)
English: DLQI 0 or 1
Icelandic: DLQI 0 eða 1
English: This is because it is not known how this medicine will affect the baby.
Icelandic: Það er vegna þess að ekki er vitað hvaða áhrif lyfið hefur á barnið
English: • It is normal to see bubbles in the window
Icelandic: Það er eðlilegt að sjá loftbólur í glugganum
English: If you stop treatment, your symptoms may come back.
Icelandic: Ef þú hættir meðferðinni geta einkennin komið aftur fram.
English: For more information and support on Skyrizi go to www.skyrizi.eu or scan this code.
Icelandic: Fyrir frekari upplýsingar og stuðning varðandi Skyrizi farið á www.skyrizi.eu eða skannið þennan kóða.
English: Campoverde di Aprilia (LT) ITALY
Icelandic: Campoverde di Aprilia (LT) Ítalía
English: • if the liquid has ever been frozen (even if thawed)
Icelandic: ef vökvinn hefur frosið (jafnvel þótt hann hafi þiðnað)
English: Weeks After Re-Randomisation
Icelandic: Vikur eftir endurslembiröðun
English: To listen to or request a copy of this leaflet in <Braille>, <large print> or <audio>, please contact the local representative of the Marketing Authorisation Holder.
Icelandic: Til að hlusta á eða sækja um afrit af þessum fylgiseðli í <Braille>, <stærra letri> eða <hljóðupptöku>, vinsamlegast hafðu samband við fulltrúa markaðsleyfishafa.
English: • Do not inject through clothes
Icelandic: Ekki á að gefa inndælingu í gegnum föt
English: However, this observation is based on a limited number of subjects.
Icelandic: Þessi niðurstaða byggist þó á takmörkuðum fjölda einstaklinga.
English: • if the expiry date (EXP) has passed
Icelandic: ef komið er fram yfir fyrningardagsetninguna (EXP)
English: This is normal
Icelandic: Það er eðlilegt
English: Check the liquid in the syringe.
Icelandic: Athugið vökvann í sprautunni.
English: Start with one syringe for the first injection.
Icelandic: Byrjið með eina sprautu fyrir fyrri inndælinguna.
English: Choose from these 3 areas to inject:
Icelandic: Veljið svæði af þessum 3 fyrir inndælingu:
English: • swelling of the face, lips, tongue or throat
Icelandic: • þrota í andliti, vörum, tungu eða hálsi
English: Do not stop using Skyrizi without talking to your doctor first.
Icelandic: Ekki á að hætta að nota Skyrizi án þess að ræða við lækninn.
English: • Do not touch the needle with your fingers or let the needle touch anything
Icelandic: Snertið ekki nálina með fingrunum og látið hana ekki komast í snertingu við neitt
English: The rate of serious infections was 1.7 events per 100 subject-years (see section 4.4).
Icelandic: Tíðni alvarlegra sýkinga var 1,7 tilvik á 100 þátttakendaárum (sjá kafla 4.4).
English: • Skyrizi should not be warmed in any other way (for example, in a microwave or in hot water)
Icelandic: Skyrizi á ekki að hita neinn hátt (t.d. í örbylgjuofni eða í heitu vatni)
English: Gender or race
Icelandic: Kyn eða kynþáttur
English: Your doctor will decide if you can keep using Skyrizi.
Icelandic: Læknirinn ákveður hvort þú eigir að halda áfram að nota Skyrizi.
English: Date of first authorisation: 26 April 2019
Icelandic: 26. apríl 2019
English: Consideration should be given to discontinuing treatment in patients who have shown no response after 16 weeks of treatment.
Icelandic: Íhuga á stöðvun meðferðar hjá sjúklingum sem hafa ekki sýnt svörun eftir 16 vikna meðferð.
English: • Repeat Steps 2 through 6 with the second syringe
Icelandic: Endurtakið skref 2 til og með 6 með seinni sprautunni
English: Insert the needle all the way into the skin at about a 45-degree angle using a quick, short movement.
Icelandic: Stingið nálinni í húðina með um 45 gráðu halla með stuttri og snöggri hreyfingu.
English: Do not inject yourself with this medicine unless you have been trained by your doctor, pharmacist or nurse.
Icelandic: Ekki gefa þér lyfið með inndælingu nema þú hafir fegið þjálfun í því hjá lækninum, lyfjafræðingi eða hjúkrunarfræðingi.