FrancophonIA/ELRC3.0 huggingface dataset:
English: If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your nuclear medicine doctor for advice before you are given this medicine.
Icelandic: Við meðgöngu, brjóstagjöf, grun um þungun eða ef þungun er fyrirhuguð skal leita ráða hjá geislalækninum áður en lyfið er notað.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING LEAD SHIELDING CONTAINER
Icelandic: SEM EIGA AÐ KOMA FRAM Á YTRI UMBÚÐUM BLÝÍLÁT TIL GEISLAVARNAR
English: Anaemia4
Icelandic: A. ÁLETRANIR
English: Sleep disorders
Icelandic: Svefntruflanir
English: The following conclusions on treatment with Lutathera were determined from radiation dosimetry evaluations performed in clinical studies:
Icelandic: Mat á geislunarmælingum í klínískum rannsóknum leiddi til eftirfarandi niðurstaðna um meðferð með Lutathera:
English: Disposable waterproof gloves should be worn.
Icelandic: Nota skal einnota vatnsþétta hanska.
English: For information on the use in patients with renal impairment, see section 4.2.
Icelandic: Upplýsingar um notkun handa sjúklingum með skerta nýrnastarfsemi er að finna í kafla 4.2.
English: Radioprotection rules
Icelandic: Reglur um vernd fyrir geislun
English: Administration of long acting somatostatin analogues should be avoided within 30 days prior to the administration of Lutathera.
Icelandic: Forðast skal notkun langverkandi sómatóstatínhliðstæða innan 30 daga fyrir gjöf Lutathera.
English: This evidence confirms what has been previously observed in the Erasmus phase I/II study, in which HPLC analysis of a urine specimen collected 1 hour post administration of lutetium (177Lu) oxodotreotide from one patient receiving 1.85 MBq of lutetium (177Lu) oxodotreotide indicated that the main portion (91%) was excreted unchanged.
Icelandic: eftir gjöf lútesín (177Lu) oxodótreótíðs úr einum sjúklingi sem fékk 1,85 MBq af lútesín (177Lu) oxodótreótíði benti til þess að stærsti hlutinn (91%) væri skilinn út óbreyttur.
English: PFS = Progression free survival; OS = Overall survival * Includes Foregut, Midgut and Hindgut; **Foregut NETs other than bronchial and pancreatic
Icelandic: PFS = Lifun án versnunar sjúkdóms; OS = Heildarlifun * Felur í sér forgirni, miðgirni og afturgirni; **NET-æxli í forgirni önnur en berkju- og bris
English: p-value of Log-rank test Hazard ratio (95%-CI)
Icelandic: Log-rank prófs Áhættuhlutfall (95%-CI) N: fjöldi sjúklinga, CI:
English: The use of Lutathera does involve exposure to amounts of radioactivity.
Icelandic: Notkun Lutathera felur í sér útsetningu fyrir geislavirkni.
English: − A pair of tongs (for Lutathera vial handling)
Icelandic: − Töng (til meðhöndlunar á Lutathera hettuglasinu)
English: Instructions for dose modifications Adjust Lutathera dosing for the following severe adverse reactions: Severe adverse reactions
Icelandic: Breytið Lutathera skömmtum vegna eftirfarandi alvarlegra aukaverkana:
English: Blood potassium decreased Blood urea increased Glycosylated haemoglobin increased
Icelandic: Blóðkalíumlækkun Þvagefnishækkun í blóði Hækkun sykraðs (glycosylated) blóðrauða
English: Breast-feeding It is unknown whether lutetium (177Lu) oxodotreotide is excreted in breast milk.
Icelandic: Ekki er vitað hvort lútesín (177Lu) oxodótreótíð skilst út í brjóstamjólk.
English: Ear and labyrinth
Icelandic: Eyru og völundarhús
English: Electrocardiogram QT prolonged
Icelandic: Lenging á QT-bili
English: One mL of solution for infusion contains
Icelandic: Einn ml af innrennslislausn inniheldur 370
English: Any woman who has missed a period should be assumed to be pregnant until proven otherwise.
Icelandic: Gera skal ráð fyrir að kona sem hefur misst úr blæðingar sé þunguð nema sönnur hafi verið færðar á hið gagnstæða.
English: At the concentration used (about 10 μg/mL in total, for both free and radiolabeled forms), the peptide oxodotreotide does not exert any clinically relevant pharmacodynamic effect.
Icelandic: Á þeim styrk sem notast er við (um það bil 10 μg/ml í heild fyrir bæði ómerkt og geislamerkt form)
English: Radioactivity in the Lutathera vial should be measured immediately before infusion using a calibrated radioactivity measurement system.
Icelandic: Mæla skal geislavirkni í Lutathera hettuglasinu rétt fyrir innrennsli með kvörðuðu mælikerfi fyrir geislavirkni.
English: Activity at infusion time: {Z} MBq - {DD/MM/YYYY hh:mm UTC}
Icelandic: {Z} MBq - {DD/MM/ÁÁÁÁ klst.klst.:mm UTC}
English: During the administration only disposable materials should be used.
Icelandic: Meðan á gjöfinni stendur skal einungis nota einnota efni og áhöld.
English: When testing the cold compound (non-radioactive lutetium (175Lu) oxodotreotide) as a single intravenous injection in rats and dogs at doses up to 20,000 µg/kg (rats) and 3,200 µg/kg (dogs), the compound was well tolerated in both species and no deaths were observed.
Icelandic: oxódotreótíð) var prófað sem stök inndæling í bláæð hjá rottum og hundum í skömmtum allt að 20.000
English: Lu) oxodotreotide or any of the other ingredients of this medicine (listed in section 6) - if you are pregnant - if your kidneys are seriously impaired
Icelandic: Ekki má nota Lutathera - ef um er að ræða ofnæmi fyrir lútesín (177Lu) oxodótreótíði eða einhverju öðru innihaldsefni lyfsins (talin upp í kafla 6) - ef þú ert þunguð - ef nýrnastarfsemi þín er alvarlega skert
English: INSTRUCTIONS FOR PREPARATION OF RADIOPHARMACEUTICALS
Icelandic: Upplýsingar fyrir notanda lyfsins
English: In spite of an observed significant selective B-cell depletion, no increase in the rate of infectious complications occurs after PRRT.
Icelandic: Þrátt fyrir að marktæk, sértæk fækkun B-frumna komi fram kemur ekki fram aukin tíðni sýkinga sem fylgikvilla eftir peptíðviðtakageislanúklíðmeðferð (peptide receptor radionuclide therapy [PRRT)]).
English: To ensure complete administration, the Lutathera vial should be kept under even pressure.
Icelandic: Til að tryggja að lyfjagjöfin sé fullkláruð skal halda Lutathera hettuglasinu undir jöfnum þrýstingi.
English: Amino acid solution should be administered over 4 hour time span.
Icelandic: Amínósýrulausn skal gefa á 4 klst. tímabili.
English: Hepatic impairment
Icelandic: Endaþarmsblæðing Sortusaur
English: Nephrotoxicity Lutetium (177Lu) oxodotreotide is excreted by the kidney.
Icelandic: Nýrnaskemmdir Lútesín (177Lu) oxodótreótíð skilst út um nýru.
English: How Lutathera is used
Icelandic: Hvernig nota á Lutathera
English: Infections and infestations
Icelandic: Inflúensulíkur sjúkdómur
English: Flatulence
Icelandic: Augnristill
English: Any unused medicinal product or waste material should be disposed of in accordance with local requirements (see section 6.6).
Icelandic: Farga skal öllum lyfjaleifum og/eða úrgangi í samræmi við gildandi reglur (sjá kafla 6.6).
English: Premedication with antiemetics should be injected 30 minutes before the start of amino acid solution infusion.
Icelandic: Gefa skal ógleðistillandi lyf í lyfjaforgjöf 30 mínútum áður en innrennsli amínósýrulausnar hefst.
English: Amount
Icelandic: Meðaltal
English: Patients with brain metastases
Icelandic: Sjúklingar með þvagleka
English: Kidneys
Icelandic: Niðurgangur
English: The high performance liquid chromatography (HPLC) analyses performed on urine samples collected up to 48 hours post infusion showed lutetium (177Lu) oxodotreotide radiochemical purity close to 100% in most of the analysed samples (with lowest radiochemical purity value being greater than 92%), indicating that the compound is eliminated in urine mainly as intact compound.
Icelandic: í flestum greindum sýnum (lægsta gildi geislaefnafræðilegs hreinleika var hærra en 92%), sem gefur til kynna að efnasambandið skiljist út í þvagi aðallega sem ósundrað efnasamband.
English: Dry skin
Icelandic: Húð
English: − Antiemetics
Icelandic: LYFJAFRÆÐILEGAR
English: • Haematology (Haemoglobin [Hb], white blood count, platelet count)
Icelandic: Blóðgildi (blóðrauði [Hb], fjöldi hvítra blóðkorna, blóðflagnafjöldi)
English: CLINICAL PARTICULARS
Icelandic: Sérstakar viðvaranir
English: Weight decreased Blood creatine phosphokinase increased
Icelandic: Hækkun kreatínfosfókínasa í blóði Hækkun laktat-dehýdrógenasi í blóði
English: PFS observed in the NETTER-1 phase III study in patients with progressive midgut carcinoid tumour - cut-off date 30 June 2016 (full analyses set (FAS), N=231)
Icelandic: PFS sem kom fram í NETTER-1 III. stigs rannsókninni hjá sjúklingum með ágengt krabbalíkisæxli í miðgirni - lokadagsetning:
English: 370 MBq lutetium (177Lu) oxodotreotide at the date and time of calibration.
Icelandic: MBq af lútesín (177Lu) oxodótreótíði á degi og tíma kvörðunar.
English: The pole height should be adjusted in order to compensate any increase or reduction of pressure inside the vial.
Icelandic: Stilla skal hæð vökvastatífsins til að vega á móti auknum eða minnkuðum þrýstingi innan hettuglassins.
English: There is evidence , from the analysis of urine samples of 20 patients included in the NETTER-1 phase III Dosimetry, pharmacokinetic and ECG substudy, that lutetium (177Lu) oxodotreotide is poorly metabolized and is excreted mainly as intact compound by renal route.
Icelandic: 20 sjúklinga sem tóku þátt í NETTER-1 III. stigs undirrannsókninni á ákvörðun geislaskammts, lyfjahvörfum og hjartalínuritum benda til þess að lútesín (177Lu)
English: Tabulated list of adverse reactions The adverse reactions are listed in Table 7 according to the frequency and the MedDRA System Organ
Icelandic: Aukaverkanirnar eru taldar upp í töflu 7 eftir tíðni og MedDRA-flokkun eftir líffærum (SOC).
English: Leukocyturia
Icelandic: LÁGMARKSUPPLÝSINGAR
English: This should be taken into consideration in patient on controlled sodium diet.
Icelandic: Þetta skal hafa í huga ef sjúklingurinn er á sérstöku mataræði hvað varðar natríum.
English: Composition of the standard amino acid solution
Icelandic: Samsetning tilgreindrar amínósýrulausnar
English: Based on the data collected during the Erasmus phase I/II and NETTER-1 phase III studies, lutetium (177Lu) oxodotreotide is primarily eliminated by renal excretion: about 60% of the medicinal product is eliminated in the urine within 24 hours, and about 65% within 48 hours following the administration.
Icelandic: Á grundvelli gagna sem var aflað í Erasmus I./II. stigs rannsókninni og NETTER-1 III. stigs rannsókninni eiga umbrot lútesín (177Lu) oxodótreótíðs sér stað fyrst og fremst með nýrnaútskilnaði:
English: Specification
Icelandic: Forskrift
English: Other medicines and Lutathera
Icelandic: Notkun annarra lyfja samhliða Lutathera
English: You will be requested to drink a sufficient amount of water (1 glass every hour) necessary to urinate every hour on the day of infusion and the day after, and try to defecate every day, in order to eliminate the medicine from your body.
Icelandic: Þú verður beðin/n um að drekka nægilegt magn af vatni (1 glas á klukkutíma fresti), sem er nauðsynlegt til að hafa þvaglát á klukkutíma fresti á innrennslisdaginn og daginn eftir, auk þess að reyna að hafa hægðir á hverjum degi til að flýta brotthvarfi lyfsins úr líkamanum.
English: Antiemetic bolus
Icelandic: Ísetning magasondu
English: Constant intra-vial pressure should be maintained during the entire infusion.
Icelandic: Viðhalda skal stöðugum þrýstingi innan hettuglassins út allt innrennslið.
English: Specification of commercially available amino acid solutions Characteristic
Icelandic: Forskrift fyrir amínósýrulausnir sem fást á almennum markaði Einkenni
English: Concomitant use of somatostatin analogues
Icelandic: Samhliða notkun á sómatóstatínhliðstæðum
English: Musculoskeletal and connective tissue disorders
Icelandic: Beinmergs- og/eða blóðsjúkdómar
English: Lutathera infusion should start 30 minutes after the beginning of the amino acid solution infusion, with the infusion rate of approximately 400 mL/h (this infusion rate is the reference rate and can be adapted depending on the patient's venous status).
Icelandic: Innrennsli Lutathera skal byrja 30 mínútum eftir að innrennsli amínósýrulausnar hefst, á innrennslishraða sem er u.þ.b. 400 ml/klst.
English: Spleen
Icelandic: Skalli
English: oxodotreotide is rapidly cleared from the blood.
Icelandic: Rannsóknir á dreifingu (biodistribution) sýna að lútesín (177Lu) oxodótreótíð hreinsast hratt úr blóði.
English: Musculoskeletal pain8 Muscle spasms
Icelandic: Bilirúbínhækkun í blóði9
English: PFS observed in the NETTER-1 phase III study in patients with progressive midgut carcinoid tumour - cut-off date 24 July 2015 (full analyses set (FAS), N=229)
Icelandic: 24. júlí 2015 (fullt greiningarþýði (FAS), N=229)
English: Gallbladder Wall Lower Large Intestine Wall Small Intestine Stomach Wall
Icelandic: Veggur neðri hluta digurgirnis 0,03 Smágirni
English: Nervous system disorders
Icelandic: Kviðverkur Hægðatregða
English: Etiology of this therapy related secondary myeloid neoplasms (t-MNs) is unclear.
Icelandic: Orsakir þessara meðferðartengdu, afleiddu beinmergsæxla (t-MNs) eru óljósar.
English: You can also report side effects directly via the national reporting system:
Icelandic: Einnig er hægt að tilkynna aukaverkanir beint samkvæmt fyrirkomulagi sem gildir í hverju landi fyrir sig, sjá Appendix V.
English: PFS Kaplan Meier curves of patients with progressive midgut carcinoid tumourcut-off date 30 June 2016 (NETTER-1 phase III study; FAS, N=231)
Icelandic: 30. júní 2016 (fullt greiningarþýði (FAS), N=231)
English: Acute prerenal failure Renal impairment
Icelandic: Ógleðistillandi lyf stakur skammtur
English: The vial is enclosed within a lead container for protective shielding.
Icelandic: Hettuglasið er geymt í blýíláti til geislavarnar, með plastinnsigli.
English: Hindgut
Icelandic: Munnbólga
English: Acute myeloid leukaemia Acute leukaemia Chronic myelomonocytic leukaemia
Icelandic: Æxlislýsuheilkenni Blóðkalsíumhækkun Blóðkalsíumlækkun
English: Overall, the results of the dosimetric analysis performed in the NETTER-1 phase III dosimetry substudy and in the Erasmus phase I/II study are in agreement and indicate that Lutathera dose regimen (4 administrations of 7,400 MBq) is safe.
Icelandic: stigs rannsókninni og benda þær til þess að skammtaáætlun Lutathera (4 skammtar af 7.400 MBq) sé örugg.
English: Pancreatitis acute Rectal haemorrhage Melaena
Icelandic: Minnkaður gauklasíunarhraði Nýrnasjúkdómur Bráð fornýrabilun (acute prerenal failure)
English: Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system:
Icelandic: Heilbrigðisstarfsmenn eru hvattir til að tilkynna allar aukaverkanir sem grunur er um að tengist lyfinu samkvæmt fyrirkomulagi sem gildir í hverju landi fyrir sig, sjá Appendix V.
English: • Bone metastasis;
Icelandic: geislavirk efni;
English: Use of toilets
Icelandic: Stoðkerfi og stoðvefur
English: Abdominal cavity drainage Dialysis
Icelandic: Sýking í öndunarvegi Blöðrubólga
English: Endocrine disorders
Icelandic: Efnaskiptablóðsýring
English: Refractory cytopenia with multilineage dysplasia (Myelodysplastic syndrome)
Icelandic: (neuroblastoma), kímhnoðaæxlum (neuroganglioblastoma), krómfíklaæxlum (phaeochromocytoma)).
English: Fatigue1
Icelandic: Lýsín-innihald
English: Abdominal distension Diarrhoea
Icelandic: Húðroði Hitakóf Lágþrýstingur
English: Intravenous use.
Icelandic: Meiriháttar skurðaðgerð.
English: Gravity infusion method - tubing connection scheme
Icelandic: Mynd 2. Þyngdaraflsinnrennsli - skýringarmynd fyrir tengingar á slöngum
English: Vasodilatation Peripheral coldness Pallor
Icelandic: Tæming/fráveita úr kviðarholi Skilun
English: Thrombocytopenia2 Lymphopenia3
Icelandic: Tel/Puh/Tlf:
English: Hepatic encephalopathy Paraesthesia Parosmia
Icelandic: Lifrarheilakvilli Náladofi
English: Pain
Icelandic: Magn
English: therefore treatment with Lutathera in those patients is not recommended.
Icelandic: Því skal meta ávinning og áhættu hjá þessum sjúklingum.
English: Arginine content
Icelandic: Beinmyndandi frumur
English: 11 Includes injection site reaction, injection site hypersensibility, injection site induration, injection site swelling * Gamma-glutamyltransferase increased **Alanine amino transferase *** Aspartate amino transferase **** Alkaline phosphatase
Icelandic: 6 Felur í sér daufkyrningafæð og fækkun daufkyrninga Felur í sér háþrýsting og háþrýstingskreppu 8 Felur í sér liðverki, verki í útlimum, bakverki, beinverki, síðuverki, brjóstverki í stoðkerfi og stoðvef og hálsverki Felur í sér aukningu bílírúbíns í blóði og gallrauðadreyra Felur í sér höfuðverk og mígreni 11 Felur í sér viðbrögð á stungustað, ofnæmi á stungustað, holdhersli (induration) á stungustað, þrota á stungustað * Gamma-glutamýltransferasi jókst **Alanín-amínótransferasi *** Aspartat-amínótransferasi **** Alkalín-fosfatasi
English: Oropharyngeal pain Pleural effusion Sputum increased Choecking sensation
Icelandic: Aukinn uppgangur (sputum) Köfnunartilfinning
English: What Lutathera contains - The active substance is lutetium (177Lu) oxodotreotide.
Icelandic: - Virka innihaldsefnið er lútesín (177Lu) oxodótreótíð.
English: NAME OF THE MEDICINAL PRODUCT Lutathera 370 MBq/mL solution for infusion
Icelandic: 370 MBq/mL
English: bilirubin)
Icelandic: bílírúbín)
English: Adequate shielding is mandatory.
Icelandic: Viðhafa skal viðeigandi smitgát.
English: Pregnancy No studies on animal reproductive function have been conducted with lutetium (177Lu) oxodotreotide.
Icelandic: á æxlun hafa farið fram með lútesín (177Lu) oxodótreótíði.
English: Criteria for temporary discontinuation treatment with Lutathera
Icelandic: Tafla 4. Viðmið um tímabundna stöðvun meðferðar með Lutathera
English: Injection site reaction11
Icelandic: Viðbrögð á stungustað11
English: Dry mouth
Icelandic: Húðþurrkur Andlitsþroti
English: Staphylococcal infections Streptococcal bacteraemia
Icelandic: Fyrri efnaskipta-geislameðferð við krabbameini (oncologic radiometabolic therapies) með
English: Brain
Icelandic: Hjarta
English: Absorbed dose estimates for lutetium (177Lu) oxodotreotide from NETTER-1 phase III study (Olinda output)
Icelandic: Áætlaður frásogaður skammtur fyrir lútesín (177Lu) oxodótreótíð á grundvelli
English: − Amino acid solution bag(s)
Icelandic: Samantektir um öryggi lyfsins (PSUR)
English: Pancytopenia
Icelandic: Hóstarkirtill
English: Lysine content
Icelandic: KLÍNÍSKAR UPPLÝSINGAR
English: Osmolarity
Icelandic: Ofsviti
English: Bronchial Pancreatic Foregut** Midgut Hindgut
Icelandic: Díetýlentríamínpentaediksýra (DTPA) Natríumklóríð
English: Haematochezia Abdominal discomfort Intestinal obstruction Colitis
Icelandic: Þykkildi á stungustað Óþægindi fyrir brjósti Brjóstverkir Sótthiti
English: Dishes and bathroom accessories Take special precautions during the 7 days after treatment: - Flush all wipes and/or toilet paper down the toilet immediately after use, - Always wash your hands well after using the toilet, - Take a shower every day, - Flush any tissues or any other items that contain anything from your body, such as blood, urine and faeces down the toilet.
Icelandic: - Skolið öllum pappírsþurrkum og öðru slíku sem hefur að geyma eitthvað úr líkamanum, svo sem blóð, þvag eða hægðir, niður í klósettið.
English: Solution for infusion
Icelandic: Vatn fyrir stungulyf
English: Contact your doctor immediately if you experience:
Icelandic: Hafðu tafarlaust samband við lækninn:
English: Do not give this medicine to children (under 12 years of age) because it does not work.
Icelandic: Gefið börnum (yngri en 12 ára) ekki þetta lyf vegna þess að það verkar ekki.
English: Ísland ratiopharm Oy
Icelandic: Ísland ratiopharm
English: Contact your doctor or the nearest hospital emergency department because of the increased risk of bleeding.
Icelandic: Hafðu samband við lækninn eða næsta sjúkrahús vegna aukinnar blæðingarhættu.
English: You should take Clopidogrel HCS for as long as your doctor continues to prescribe it.
Icelandic: Þú skalt taka Clopidogrel HCS meðan læknirinn heldur áfram að ávísa því.
English: HCS bvba, H. Kennisstraat 53, B 2650 Edegem, Belgium
Icelandic: HCS bvba, H. Kennisstraat 53, B 2650 Edegem, Belgía
English: Some other medicines may influence the use of Clopidogrel HCS or vice versa.
Icelandic: Sum önnur lyf geta haft áhrif á notkun Clopidogrel HCS og öfugt.
English: HCS bvba H. Kennisstraat 53 B-2650 Edegem Belgium
Icelandic: HCS bvba H. Kennisstraat 53 B 2650 Edegem Belgía
English: For the 28x1 tablets pack size, you can check the day on which you last took a tablet of Clopidogrel HCS by referring to the calendar printed on the blister.
Icelandic: Hvað varðar pakkningastærð með 28x1 töflu má athuga á hvaða degi síðasta tafla af Clopidogrel HCS var tekin með því að skoða dagatalið sem er prentað á þynnupakkninguna.
English: What Clopidogrel HCS is and what it is used for What you need to know before you take Clopidogrel HCS How to take Clopidogrel HCS Possible side effects
Icelandic: Upplýsingar um Clopidogrel HCS og við hverju það er notað Áður en byrjað er að nota Clopidogrel HCS Hvernig nota á Clopidogrel HCS Hugsanlegar aukaverkanir
English: The other ingredients are (see section 2 ‘Clopidogrel HCS contains hydrogenated castor oil'):
Icelandic: Önnur innihaldsefni eru (sjá kafla 2 „Clopidogrel HCS inniheldur herta laxerolíu“):
English: The most common side effect reported with Clopidogrel HCS is bleeding.
Icelandic: Algengasta aukaverkunin sem tilkynnt hefur verið um vegna Clopidogrel HCS er blæðingar.
English: Krka, d.d., Novo mesto Šmarješka cesta 6
Icelandic: KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slóvenía
English: The film-coated tablets are pink, round and slightly convex.
Icelandic: Filmuhúðuðu töflurnar eru, bleikar, kringlóttar og örlítið kúptar.
English: • Adults and elderly (over 65 years) Clopidogrel should be given as a single daily dose of 75 mg.
Icelandic: Fullorðnir og aldraðir (eldri en 65 ára) Klópídógrel á að gefa í einum daglegum 75 mg skammti.
English: The population included 27.8% women, 58.4% patients ≥60 years (26% ≥70 years) and
Icelandic: 27,8% sjúklingaþýðisins voru konur, 58,4% sjúklinga voru ≥ 60 ára (26% ≥ 70 ára) og 54,5%
English: What Clopidogrel HCS is and what it is used for
Icelandic: Upplýsingar um Clopidogrel HCS og við hverju það er notað
English: Polyvinyl alcohol Titanium dioxide (E171) Red iron oxide (E172) Yellow iron oxide (E172) Talc
Icelandic: Títan tvíoxíð (E171) Rautt járnoxíð (E172) Gult járnoxíð (E172) Talkúm
English: If you have experienced severe chest pain (unstable angina or heart attack), your doctor may give you 300 mg of Clopidogrel HCS (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 Clopidogrel HCS (fjórar 75 mg töflur) í eitt skipti við upphaf meðferðar.
English: In a clinical study conducted in healthy subjects, clopidogrel did not necessitate modification of the heparin dose or alter the effect of heparin on coagulation.
Icelandic: Í klínískri rannsókn á heilbrigðum einstaklingum olli klópídógrel ekki þörf fyrir breytingu á skammti heparíns og breytti ekki áhrifum heparíns á storknun.
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: Clopidogrel has been evaluated for safety in more than 44,000 patients who have participated in clinical studies, including over 12,000 patients treated for 1 year or more.
Icelandic: öryggis hjá rúmlega 44.000 sjúklingum, sem hafa tekið þátt í klínískum rannsóknum, þ.á m. voru meira en 12.000 sjúklingar meðhöndlaðir í 1 ár eða lengur. .
English: Your doctor should have prescribed Clopidogrel HCS 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 Clopidogrel HCS og acetýlsalicýlsýru ef þú getur ekki tekið blóðþynningarlyf og ef þú ert ekki í hættu á að fá miklar blæðingar
English: It is preferable not to take this product during pregnancy.
Icelandic: Helst ætti ekki að taka þetta lyf á meðgöngu.
English: Finnland Sími: +358 20 180 5900
Icelandic: Sími: +358 20 180 5900
English: NSAIDs
Icelandic: NSAID
English: - fever, signs of infection or extreme tiredness.
Icelandic: - ef þú færð hita, merki um sýkingu eða verður mjög þróttlaus.