FrancophonIA/ELRC3.0 huggingface dataset:
English: After first opening the bottle use within 30 days.
Icelandic: Notist innan 30 daga frá fyrstu opnun.
English: • the mother and the neonate, at the end of pregnancy, to: - possible prolongation of bleeding time, an anti-aggregating effect which may occur even
Icelandic: hjá móður og nýbura við lok meðgöngu: - hugsanlegri lengingu á blæðingartíma, verkun sem hemur blóðflagnasamloðun og getur jafnvel komið fram við mjög litla skammta; - hömlun á samdrætti legs og seinkun fæðingar.
English: Other medicinal products: A number of other clinical studies have been conducted with clopidogrel and other concomitant medicinal products to investigate the potential for pharmacodynamic and pharmacokinetic (PK) interactions.
Icelandic: Margar aðrar klínískar rannsóknir hafa verið gerðar á samhliða gjöf klópídógrels og annarra lyfja til þess að greina hvort hún hafi áhrif á lyfhrif eða lyfjahvörf.
English: If the use of the combination of clopidogrel/acetylsalicylic acid is discontinued, patients may benefit with continuation of one antiplatelet medicinal product.
Icelandic: Ef notkun á samsetningu klópídógrels og acetýlsalicýlsýru er hætt getur verið að sjúklingar hafi hag af að halda áfram meðferð með einu blóðflöguvirku lyfi.
English: Consistent with the above results, in a meta analysis including 6 studies of 335 clopidogrel-treated subjects at steady state, it was shown that active metabolite exposure was decreased by 28% for intermediate metabolisers, and 72% for poor metabolisers while platelet aggregation inhibition (5 μM ADP) was decreased with differences in IPA of 5.9% and 21.4%, respectively, when compared to extensive metabolisers.
Icelandic: Í samræmi við niðurstöðurnar hér að ofan sýndi safngreining sem tók til sex rannsókna með 335 einstaklingum sem voru meðhöndlaðir með klópídógrel við jafnvægi, að útsetning fyrir virka umbrotsefninu minnkaði um 28% hjá þeim sem voru með í meðallagi mikið umbrot og um 72% hjá þeim sem voru með lélegt umbrot.
English: • If you suffer from severe kidney disease.
Icelandic: ef þú ert með alvarlegan nýrnasjúkdóm
English: - In patients with non-ST segment elevation acute coronary syndrome (unstable angina or non-Q-wave myocardial infarction): The optimal duration of treatment has not been formally established.
Icelandic: - Hjá sjúklingum með brátt kransæðaheilkenni án ST-hækkunar (hvikula hjartaöng eða hjartadrep án Q-takka-myndunar):
English: • sudden life-threatening allergic reactions
Icelandic: skyndileg lífshættuleg ofnæmisviðbrögð
English: In addition, increased incidences of various malformations, including cardiovascular, have been reported in animals given a prostaglandin synthesis inhibitor during the organogenetic period.
Icelandic: Auk þess hefur verið greint frá aukinni tíðni vanskapana þ.á m. hjarta- og æðakerfis, hjá dýrum sem fá lyf sem hemja myndun prostaglandína, meðan á myndun líffæra stendur.
English: (psoriasis),
Icelandic: • niðurgangur,
English: Initial hyperventilation leads to respiratory alkalosis.
Icelandic: Í byrjun veldur oföndun öndunarblóðlýtingi.
English: • breathing difficulties sometimes associated with cough
Icelandic: öndunarörðugleikar stundum með hósta
English: The concomitant administration of the combination of clopidogrel/acetylsalicylic acid with oral anticoagulants is not recommended since it may increase the intensity of bleeding (see section 4.5).
Icelandic: Samhliða gjöf á samsetningu klópídógrels og acetýlsalicýlsýru og segavarnarlyfja til inntöku er ekki ráðlögð þar sem blæðingar gætu orðið meiri (sjá kafla 4.5).
English: Rare side effect (may affect up to 1 in 1000 people): • vertigo.
Icelandic: Mjög sjaldgæf aukaverkun (getur komið fyrir hjá allt að 1 af hverjum 1.000 einstaklingum): • svimi.
English: The combination of clopidogrel/acetylsalicylic acid must not be used in patients with severe renal impairment (see section 4.3).
Icelandic: Samsetningu klópídógrels og acetýlsalicýlsýru má ekki nota hjá sjúklingum með verulega skerta nýrnastarfsemi (sjá kafla 4.3).
English: White HDPE bottles and green polypropylene (PP) child-resistant closures with dessicant.
Icelandic: Hvítar HDPE glös með grænum barnaöryggislokum úr pólýprópýleni og þurrkefni.
English: Breast-feeding should be discontinued during treatment with the combination of clopidogrel/acetylsalicylic acid.
Icelandic: Stöðva á brjóstagjöf meðan á meðferð með Clopidogrel/Acetylsalicylic acid Teva stendur.
English: Clopidogrel/Acetylsalicylic acid Teva should be given as a single daily 75 mg/75 mg dose.
Icelandic: Clopidogrel/Acetylsalicylic acid Teva á að gefa í einum daglegum 75 mg/75 mg skammti.
English: • Hepatic impairment
Icelandic: • lækkun blóðþrýstings
English: Clopidogrel/Acetylsalicylic acid Teva should be given as a single daily 75 mg/100 mg dose.
Icelandic: Clopidogrel/Acetylsalicylic acid Teva á að gefa í einum daglegum 75 mg/100 mg skammti.
English: 4.7 Effects on ability to drive and use machines
Icelandic: Akstur og notkun véla
English: The marketing authorisation holder shall submit PSURs for this product in accordance with the requirements set out in the list of Union reference dates (EURD list) provided for under Article
Icelandic: Markaðsleyfishafi skal leggja fram samantektir um öryggi lyfsins í samræmi við skilyrði sem koma fram í lista yfir viðmiðunardagsetningar Evrópusambandsins (EURD lista) sem gerð er krafa um í grein 107c(7) í tilskipun 2001/83 og er birtur í vefgátt fyrir evrópsk lyf.
English: • excessive gas in stomach or intestines
Icelandic: • aukin loftmyndun í maga eða þörmum
English: Reproduction toxicity data show that ASA is teratogenic in several laboratory animals.
Icelandic: Æxlunarrannsóknir sýna að acetýlsalicýlsýra valdi vansköpun hjá nokkrum rannsóknardýrum.
English: • The other ingredients are: Tablet core: lactose monohydrate, microcrystalline cellulose, hydroxypropylcellulose 100 cP, crospovidone (type A), stearic acid, croscarmellose sodium, hydrogenated vegetable oil and sodium lauril sulfate.
Icelandic: Töflukjarni: laktósaeinhýdrat, örkristallaður sellulósi, hýdroxýprópýlsellulósi 100 cP, krospóvídón (tegund A), stearínsýra, natríumkroskarmellósa, mettuð jurtaolía og natríumlaurýlsúlfat.
English: However, if you are concerned by your bleeding, you should contact your doctor straightaway (see section 2 ‘Warnings and precautions').
Icelandic: Hafðu þó strax samband við lækninn ef þú hefur áhyggjur af blæðingunni (sjá kafla 2, Gæta skal sérstakrar varúðar við notkun Clopidogrel/Acetylsalicylic acid Teva).
English: Clopidogrel/Acetylsalicylic acid Teva 75 mg/75 mg
Icelandic: Clopidogrel/Acetylsalicylic acid Teva 75 mg/75 mg töflur
English: Eye disorders Ear and labyrinth disorders
Icelandic: Eyru og völundarhús
English: • Non-ST segment elevation acute coronary syndrome (unstable angina or non-Q-wave myocardial infarction) including patients undergoing a stent placement following percutaneous
Icelandic: Brátt kransæðaheilkenni án ST-hækkunar(hvikula hjartaöng eða hjartadrep án Q-takka myndunar), þ.á m. hjá sjúklingum sem gangast undir stoðnetsísetningu eftir kransæðavíkkun.
English: Thrombotic Thrombocytopenic Purpura (TTP) has been reported very rarely following the use of clopidogrel, sometimes after a short exposure.
Icelandic: Örsjaldan hefur verið lýst purpura með segamyndun og fækkun blóðflagna (TTP) eftir notkun klópídógrels, stundum eftir notkun í skamman tíma.
English: Depending on your condition, your doctor will determine the length of time for which you need to take Clopidogrel/Acetylsalicylic acid Teva.
Icelandic: Læknirinn ákveður hversu lengi þú þarft að taka Clopidogrel/Acetylsalicylic acid Teva en það fer eftir sjúkdómsástandi þínu.
English: Film-coated tablet 30 film-coated tablets
Icelandic: Filmuhúðaðar töflur 14 filmuhúðaðar töflur
English: How to store Clopidogrel/Acetylsalicylic acid Teva
Icelandic: Hvernig geyma á Clopidogrel/Acetylsalicylic acid Teva
English: Hypoglycaemia*, gout* (see section
Icelandic: Bólgueyðandi gigtarlyf (NSAID)
English: While you are taking Clopidogrel/Acetylsalicylic acid Teva:
Icelandic: Meðan á Clopidogrel/Acetylsalicylic acid Teva meðferð stendur:
English: • If you have a medical condition that is currently causing bleeding such as a stomach ulcer or bleeding within the brain.
Icelandic: ef þú ert með sjúkdóm sem veldur virkri blæðingu svo sem magasár eða heilablæðingu
English: Very rare, not known among thienopyridines (such as ticlopidine, prasugrel) (see section 4.4)*
Icelandic: Bráðaofnæmislost*, Sermissótt, bráðaofnæmislík viðbrögð, versnun einkenna fæðuofnæmis*, krossofnæmi meðal tíenópýridína (svo sem ticlopidin, prasugrel) (sjá kafla 4.4)*,
English: Clopidogrel/Acetylsalicylic acid Teva contains clopidogrel and acetylsalicylic acid (ASA) and belongs to a group of medicines called antiplatelet medicinal products.
Icelandic: Clopidogrel/Acetylsalicylic acid Teva inniheldur klópídógrel og acetýlsalicýlsýru og tilheyrir flokki lyfja sem hindra samloðun blóðflagna.
English: Clopidogrel/Acetylsalicylic acid Teva 75 mg/100 mg
Icelandic: MEÐ BLINDRALETRI Clopidogrel/Acetylsalicylic acid Teva 75 mg/100 mg
English: Very rare side effects (may affect up to 1 in 10,000 people):
Icelandic: Aukaverkanir sem koma örsjaldan fyrir (geta komið fyrir hjá allt að 1 af hverjum 10.000):
English: Other concomitant therapy with ASA
Icelandic: Önnur samhliða meðferð með acetýlsalicýlsýru
English: How to take Clopidogrel/Acetylsalicylic acid Teva
Icelandic: Hvernig nota á Clopidogrel/Acetylsalicylic acid Teva
English: Although minor upper GI symptoms, such as dyspepsia, are common and can occur anytime during therapy, physicians should remain alert for signs of ulceration and bleeding, even in the absence of previous GI symptoms.
Icelandic: Minniháttar einkenni frá meltingarvegi, eins og t.d. meltingartruflun, eru algeng og geta komið fram hvenær sem er meðan á meðferð stendur.
English: Clopidogrel: Overdose following clopidogrel administration may lead to prolonged bleeding time and subsequent bleeding complications.
Icelandic: Ofskömmtun klópídógrels getur leitt til lengingar á blæðingartíma og þar með blæðinga.
English: Tablet core:
Icelandic: Filmuhúðun:
English: What Clopidogrel/Acetylsalicylic acid Teva contains
Icelandic: Clopidogrel/Acetylsalicylic acid Teva inniheldur
English: • indigestion or heartburn.
Icelandic: • meltingartruflanir eða brjóstsviði.
English: Taste disturbances
Icelandic: Bragðtruflanir
English: Therefore, the combination of clopidogrel/acetylsalicylic acid should be used with caution in these patients.
Icelandic: Því skal gæta varúðar við notkun á samsetningu klópídógrels og acetýlsalicýlsýru hjá þessum sjúklingum.
English: • worsening of food allergies.
Icelandic: • versnun fæðuofnæmis.
English: How to store Clopidogrel/Acetylsalicylic acid Teva Contents of the pack and other information
Icelandic: Lýsing á útliti Clopidogrel/Acetylsalicylic acid Teva og pakkningastærðir
English: Consequently, the concomitant use of NSAIDs including Cox-2 inhibitors is not recommended (see section 4.4).
Icelandic: Cox-2 hemlar þar með taldir, (sjá kafla 4.4).
English: However, if you are concerned by your bleeding, you should contact your doctor straightaway (see section 4
Icelandic: Hafðu þó strax samband við lækninn ef þú hefur áhyggjur af blæðingunum (sjá kafla 4, „Hugsanlegar aukaverkanir“).
English: • jaundice
Icelandic: • kláði
English: • ST segment elevation acute myocardial infarction in medically treated patients eligible for
Icelandic: Brátt hjartadrep með ST-hækkun hjá sjúklingum sem eru í lyfjameðferð og uppfylla skilyrði
English: Mogilska 80.
Icelandic: B01AC30.
English: Excipients
Icelandic: ofskynjanir
English: • signs of liver problems such as yellowing of the skin and/or the eyes (jaundice), whether or not associated with bleeding which appears under the skin as red pinpoint dots, and/or confusion (see section 2 ‘Warnings and precautions').
Icelandic: Þetta gæti verið vegna þess að einstaka sinnum fækkar sumum gerðum blóðkorna - ef þú færð einkenni lifrarsjúkdóma, svo sem ef húð og/eða augu gulna (gula), hvort sem það tengist blæðingu sem kemur fram undir húð sem rauðar doppur á stærð við títuprjónsodd og/eða ringlun eða ekki (sjá kafla 2, „Varnaðarorð og varúðarreglur“) - ef þú færð munnþrota eða einkenni frá húð, svo sem útbrot og kláða eða blöðrur.
English: Acute liver failure, liver injury, mainly hepatocellular*, hepatitis, elevation of hepatic
Icelandic: Bráð lifrarbilun, lifrarskaði, aðallega í lifrarfrumum*, lifrarbólga, hækkuð gildi lifrarensíma*, óeðlileg lifrarpróf
English: Thrombolytics
Icelandic: Hert jurtaolía
English: Bleeding time prolonged, neutrophil count decreased, platelet count decreased * Information reported in published information for ASA (frequency “not known”).
Icelandic: Rannsóknaniðurstöður blæðingatími, fækkun hlutleysiskyrninga og fækkun blóðflagna * Upplýsingar sem koma fram í gögnum um acetýlsalicýlsýru þar sem tíðni er „ekki þekkt“.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON for bottles
Icelandic: YTRI UMBÚÐUM YTRI ASKJA fyrir þynnur
English: • Renal impairment
Icelandic: • nýrnasjúkdómar
English: Polydextrose
Icelandic: Taugakerfi
English: There is insufficient clinical experience regarding the use of doses above 100 mg/day up to 500 mg/day.
Icelandic: Klínísk reynsla af skömmtum yfir 100 mg/sólahring allt að 500 mg/sólahring er ófullnægjandi.
English: Hearing loss* or tinnitus*
Icelandic: Heyrnartap* eða eyrnasuð*
English: NSAIDs
Icelandic: sundl
English: • constipation
Icelandic: • uppköst
English: No clinical data on exposure to the combination of clopidogrel/acetylsalicylic acid during pregnancy are available.
Icelandic: Engin klínísk gögn liggja fyrir um notkun á samsetningu klópídógrels og acetýlsalicýlsýru á meðgöngu.
English: • hallucinations
Icelandic: • ógleði
English: Clopidogrel/Acetylsalicylic acid Teva 75 mg/75 mg film-coated tablets clopidogrel/acetylsalicylic acid
Icelandic: Clopidogrel/Acetylsalicylic acid Teva 75 mg/75 mg filmuhúðaðar töflur Klópídógrel/acetýlsalicýlsýra
English: Gastrointestinal (GI)
Icelandic: VIRK(T) EFNI
English: Following absorption, the ASA in the combination of clopidogrel/acetylsalicylic acid is hydrolyzed to salicylic acid with peak plasma levels of salicylic acid occurring within 1 hour of dosing, such that plasma levels of ASA are essentially undetectable 1.5-3 hours after dosing.
Icelandic: Eftir frásog verður acetýlsalicýlsýran í samsetningu klópídógrels og acetýlsalicýlsýru fyrir vatnsrofi og breytist í salicýlsýru, hámarks-plasmaþéttni salicýlsýrunnar næst 1 klst.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 75 mg of clopidogrel (as hydrogen sulphate) and 75 mg of acetylsalicylic acid (ASA).
Icelandic: VIRK INNIHALDSEFNI OG STYRKLEIKAR Hver filmuhúðuð tafla inniheldur 75 mg af klópídógreli (sem hýdrógensúlfat) og 75 mg af acetýlsalicýlsýru.
English: Pharmacodynamic effects
Icelandic: - Produtos Farmacêuticos Lda
English: NAME OF THE MEDICINAL PRODUCT Clopidogrel/Acetylsalicylic acid Teva 75 mg/75 mg film-coated tablets
Icelandic: HEITI LYFS Clopidogrel/Acetylsalicylic acid Teva 75 mg/75 mg filmuhúðaðar töflur
English: There is no information concerning overdose with the combination of clopidogrel/acetylsalicylic acid.
Icelandic: Ekki eru fyrirliggjandi upplýsingar um ofskömmtun á samsetningu klópídógrels og acetýlsalicýlsýru.
English: NAME OF THE MEDICINAL PRODUCT Clopidogrel/Acetylsalicylic acid Teva 75 mg/100 mg film-coated tablets
Icelandic: HEITI LYFS Clopidogrel/Acetylsalicylic acid Teva 75 mg/100 mg filmuhúðaðar töflur
English: Do not take Clopidogrel/Acetylsalicylic acid Teva
Icelandic: Ef hætt er að taka Clopidogrel/Acetylsalicylic acid Teva
English: Retroperitoneal haemorrhage
Icelandic: Sérhæfðir serótónín endurupptöku hemlar (SSRI)
English: What Clopidogrel/Acetylsalicylic acid Teva looks like and contents of the pack Clopidogrel/Acetylsalicylic acid Teva 75 mg/100 mg film-coated tablets are light pink to pink, film-coated capsule shaped tablets.
Icelandic: Clopidogrel/Acetylsalicylic acid Teva 75 mg/100 mg filmuhúðaðar töflur eru ljósbleikar til bleikar, filmuhúðaðar, hylkislaga töflur.
English: • burning in stomach and/or oesophagus
Icelandic: • sviði í maga og/eða vélinda
English: • inflammation of small vessels.
Icelandic: • bólga í litlum æðum.
English: Tablet coating:
Icelandic: Lyfjaerfðafræði:
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: Clopidogrel/Acetylsalicylic acid Teva 75 mg/100 mg film-coated tablets clopidogrel/acetylsalicylic acid
Icelandic: Clopidogrel/Acetylsalicylic acid Teva 75 mg/100 mg filmuhúðaðar töflur Klópídógrel/acetýlsalicýlsýra
English: Clopidogrel/Acetylsalicylic acid Teva 75 mg/100 mg film-coated tablets Clopidogrel/Acetylsalicylic acid
Icelandic: Clopidogrel/Acetylsalicylic acid Teva 75 mg/100mg filmuhúðaðar töflur klópídógrel/ acetýlsalicýlsýra
English: This effect lasts for the life of the platelet.
Icelandic: Þessi áhrif verka út líftíma blóðflagnanna.
English: carmine (E120), iron oxide red (E172).
Icelandic: Rautt járnoxíð (E172)
English: What Clopidogrel/Acetylsalicylic acid Teva looks like and contents of the pack Clopidogrel/Acetylsalicylic acid Teva 75 mg/75 mg film-coated tablets are yellow, film-coated capsule shaped tablets.
Icelandic: Clopidogrel/Acetylsalicylic acid Teva 75 mg/75 mg filmuhúðaðar töflur eru gular, filmuhúðaðar, hylkislaga töflur.
English: Thrombotic thrombocytopenic purpura (TTP) (see section 4.4), aplastic anaemia, pancytopenia, agranulocytosis, severe thrombocytopenia, granulocytopenia, anaemia, acquired haemophilia A.
Icelandic: Purpuri með segamyndun og fækkun blóðflagna (TTP) (sjá kafla 4.4), vanmyndunarblóðleysi, blóðfrumnafæð, kyrningahrap, veruleg blóðflagnafæð, kyrningafæð, blóðleysi, áunnin dreyrasýki A,
English: Therefore, concomitant use should be undertaken with caution (see section
Icelandic: Því skal gæta varúðar við samhliða notkun þeirra (sjá kafla 4.4).
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 75 mg of clopidogrel (as hydrogen sulphate) and 100 mg of acetylsalicylic acid (ASA).
Icelandic: VIRK INNIHALDSEFNI OG STYRKLEIKAR Hver filmuhúðuð tafla inniheldur 75 mg af klópídógreli (sem hýdrógensúlfat) og 100 mg af acetýlsalicýlsýru.
English: Salicylic acid in the combination of clopidogrel/acetylsalicylic acid has a plasma half-life of approximately 2 hours.
Icelandic: Helmingunartími salicýlsýru í samsetningu klópídógrels og acetýlsalicýlsýru í plasma er u.þ.b. 2 klst.
English: • muscular pain
Icelandic: • breytt bragðskyn
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 75 mg of clopidogrel (as hydrogen sulphate) and 100 mg of acetylsalicylic acid.
Icelandic: Hver filmuhúðuð tafla inniheldur 75 mg af klópídógreli (sem hýdrógensúlfat) og 100 mg af acetýlsalicýlsýru.
English: • probenecid, benzbromarone, or sulfinpyrazone, medicines used to treat gout,
Icelandic: Lyf, sem hindra samloðun blóðflagna, önnur en heparín, ATC flokkur:
English: Norge
Icelandic: Algengar
English: Biotransformation
Icelandic: Lyfjaerfðafræði
English: Teva Pharmaceuticals S.R.L Tel: +4021 230 6524
Icelandic: Tel: +4021 230 65 24
English: With severe intoxication, serious disturbances of the acid-base equilibrium occur.
Icelandic: Við alvarleg eitrunaráhrif getur komið fram veruleg röskun á sýru-basajafnvægi.
English: Medicinal product subject to medical prescription
Icelandic: Upplýsingar fyrir notanda lyfsins
English: Sachet (PET/Alu/LLDPE)
Icelandic: Skammtapoki (PET/ál/LLDPE)
English: 1 capsule (125 mg) + 2 capsules (80 mg)
Icelandic: 125 mg + 80 mg Hylki, hart Til inntöku þynnupakkning (ál) 1 hylki (125 mg) + 2 hylki (80 mg)
English: 1 sachet + 2 dispensers + 1 cap + 1 mixing cup
Icelandic: + 1 hetta+ 1 blöndunarmál
English: 2 capsules
Icelandic: 1 hylki
English: Capsule, hard Oral use
Icelandic: Lyfjaform Íkomuleið Innri umbúðir
English: Always use this medicine exactly as your doctor has told you.
Icelandic: Notið lyfið alltaf alveg eins og læknirinn hefur sagt til um.
English: Has it been 48 hours or longer since your last bowel movement?
Icelandic: Eru liðnir 48 tímar eða meira síðan þú hafðir síðast hægðir?
English: Important notes:
Icelandic: Mikilvægar athugasemdir:
English: Do not give this medicine to children and adolescents under the age of 18 because the potential risks and benefits are not known.
Icelandic: Ekki gefa þetta lyf börnum og unglingum yngri en 18 ára þar sem hugsanleg áhætta og ávinningur eru ekki þekkt.
English: If it is not, do not use the solution.
Icelandic: Ef lausnin er það ekki skal ekki nota hana.
English: 18 months
Icelandic: 18 mánuðir.
English: Studies have been conducted in juvenile rats and dogs.
Icelandic: Rannsóknir hafa verið gerðar á ungum rottum og ungum hundum.
English: Please read and follow them step by step.
Icelandic: Vinsamlegast lestu þær og fylgdu þeim skref fyrir skref.
English: This medicine is for use in adults (aged 18 and over).
Icelandic: Lyfið er ætlað fullorðnum (18 ára og eldri).
English: Wincentego Pola 21 58-500 Jelenia Góra, Poland
Icelandic: Pola 21 58-500 Jelenia Góra, Poland
English: Cmax was not significantly changed.
Icelandic: Ekki varð breyting á Cmax að ráði.
English: The following side effects are very common and may affect more than 1 in 10 people.
Icelandic: Eftirfarandi aukaverkanir eru mjög algengar og gætu komið fyrir hjá fleiri en 1 af hverjum 10 einstaklingum.
English: Your doctor will determine your dose.
Icelandic: Læknirinn mun ákvarða skammtinn fyrir þig.
English: There is no need to worry about this as it will not affect the accuracy of the dose or pose any risk to your health.
Icelandic: Ekki þarf að hafa áhyggjur af þessu þar sem það hefur ekki áhrif á nákvæmni skammtsins og engin hætta stafar af því.
English: Are you mobile enough to reach the toilet, or do you have a caregiver looking after you who can help?
Icelandic: Hefur þú næga fótaferð til að komast á salerni, eða ertu í umsjá umönnunaraðila sem getur hjálpað þér?
English: Please read the instructions carefully and follow them step by step.
Icelandic: Vinsamlegast lestu leiðbeiningarnar vandlega og fylgdu þeim skref fyrir skref.
English: There may be a little bleeding at the injection site.
Icelandic: Það gæti blætt örlítið á stungustaðnum.
English: Always make sure you have the correct dose in the syringe.
Icelandic: Gættu þess alltaf að vera með réttan skammt í sprautunni.
English: Wash your hands thoroughly with soap and warm water.
Icelandic: Þvoðu hendurnar vandlega með sápu og volgu vatni.
English: In these studies, the median age was 68 years (range 21-100); 51 % were females.
Icelandic: Í þessum rannsóknum var miðgildi aldurs 68 ár (21-100 ár); 51 % voru konur.
English: Dose (mL) = patient weight (kg) x 0.0075
Icelandic: Skammtur (ml) = líkamsþyngd sjúklings (kg) x 0,0075
English: When you hear a click sound that means the entire contents were injected.
Icelandic: Þegar þú heyrir smell þýðir það að öllu innihaldinu hefur verið sprautað.
English: How often this happens is not known from the data that is available.
Icelandic: Ekki er hægt að sjá af fyrirliggjandi gögnum hversu oft þetta gerist.
English: Throughout both study periods, patients maintained their usual laxative regimen.
Icelandic: Á báðum rannsóknartímabilunum héldu sjúklingarnir áfram sinni hefðbundnu hægðalosandi meðferð.
English: Are you familiar with the technique of self injection or have you discussed this with your doctor (or nurse or pharmacist)?
Icelandic: Þekkirðu aðferðina við að sprauta þig sjálf/ur eða hefurðu rætt þetta við lækninn (eða hjúkrunarfræðing eða lyfjafræðing)?
English: (See INSTRUCTIONS FOR PREPARING AND GIVING AN INJECTION OF RELISTOR at the end of this leaflet.)
Icelandic: (Sjá LEIÐBEININGAR UM UNDIRBÚNING OG INNDÆLINGU RELISTOR aftast í þessum fylgiseðli.)
English: After withdrawal in the injection syringe:
Icelandic: Eftir að það hefur verið dregið upp í sprautuna:
English: This will mean that the safety mechanism has been activated, and the needle will disappear into the syringe.
Icelandic: Það þýðir að öryggiskerfið hefur verið virkjað og að nálin mun hverfa inn í sprautuna.