FrancophonIA/ELRC3.0 huggingface dataset:
English: Duration of treatment of invasive candidiasis should be based upon the patient's clinical and microbiological response.
Icelandic: Lengd meðferðar við ífarandi Candida sveppasýkingu er einstaklingsbundin og skal miðuð við klíníska- og örverufræðilega svörun sjúklingsins.
English: The overall success rates in the MITT analysis results, adjusted by risk strata, were as follows: 46.6 % (26/56) for caspofungin and 32.2 % (8/25) for liposomal amphotericin B.
Icelandic: 46,6% (26/56) fyrir caspófúngín og 32,2% (8/25) fyrir fitukorna amfóterisín B.
English: Before preparation of infusion, calculate the body surface area (BSA) of the patient using the following formula: (Mosteller Formula)
Icelandic: Áður en blöndun hefst skal reikna yfirborðflatarmál sjúklingsins (BSA) með eftirfarandi formúlu:
English: What is in this leaflet
Icelandic: Þessi aukning
English: b Visually inspect the reconstituted solution for particulate matter or discoloration during reconstitution and prior to infusion.
Icelandic: b.Skoðið stofnlausnina vandlega með tilliti til agna eða óeðlilegs litar á meðan blöndun stendur og áður en til innrennslis kemur.
English: This infusion solution must be used within 24 hours if stored at or below 25°C or within 48 hours if stored refrigerated at 2 to 8°C.
Icelandic: Nota verður lausnina innan 24 klst. ef hún er geymd við 25°C eða við lægri hita eða 48 klst.
English: Paediatric Patients: In adolescents (ages 12 to 17 years) receiving caspofungin at 50 mg/m2 daily (maximum 70 mg daily),
Icelandic: Hjá unglingum (12-17 ára) sem fengu caspófúngín 50 mg/m2 einu sinni á dag (hámark 70 mg daglega)
English: Aseptically add 10.5 mL of water for injection.a This reconstituted solution may be stored for up to 24 hours at or below 25°C.b This will give a final caspofungin concentration in the vial of
Icelandic: Bætið með smitgát 10,5 ml af vatni fyrir stungulyf. a. Geyma má blönduðu lausnina allt upp í 24 klukkustundir við 25°C eða við lægri hita en 25°C.b Þessi lausn hefur caspófúngín styrk
English: This finding may indicate that paediatric patients will have similar reductions with inducers as seen in adults.
Icelandic: Þessar niðurstöður geta gefið til kynna að samskonar áhrifa gætir af virkjumhjá börnum og fullorðnum.
English: • Decreased blood albumin (a type of protein) in your blood, decreased potassium or low potassium levels in the blood
Icelandic: Lækkun á blóðalbúmíni (próteintegund) í blóðinu, lækkað kalíumgildi eða lágt kalíumgildi í blóðinu
English: In some adult and paediatric patients with serious underlying conditions who were receiving multiple concomitant medications with caspofungin, cases of clinically significant hepatic dysfunction, hepatitis and hepatic failure have been reported; a causal relationship to caspofungin has not been established.
Icelandic: Greint hefur verið frá klínískt mikilvægum tilvikum lifrarvanstarfsemi, lifrarbólgu og lifrarbilunar hjá sumum fullorðnum sjúklingum og börnum með alvarlega undirliggjandi sjúkdóma sem fá samhliðameðferð með fleiri lyfjum ásamt caspófúngíni, ekki hefur verið sýnt fram á orsakatengsl við caspófúngín.
English: Psychiatric anxiety, disorientation, insomnia disorders
Icelandic: Vistarfirring, taugaóstyrkur, svefnleysi
English: INSTRUCTIONS FOR USE IN ADULT PATIENTS (Caspofungin Accord 50 mg)
Icelandic: LEIÐBEININGAR FYRIR NOTKUN HJÁ FULLORÐNUM (Caspofungin Accord 50 mg)
English: How to use Caspofungin Accord
Icelandic: Hvernig nota á Caspofungin Accord
English: 50 mg at reduced volume
Icelandic: 50 mg, minna rúmmál
English: Two intermediate products, formed during the degradation of caspofungin to this open ring compound, form covalent adducts to plasma proteins resulting in a low-level, irreversible binding to plasma proteins.
Icelandic: Tvö milliefni, sem verða til við umbrot caspófúngíns í opna hringlaga efnið, mynda samgildar aðfærur (covalent adducts) við prótein í blóðvökva og myndast því lítið magn óafturkræfrar bindingar við prótein í blóðvökvanum.
English: In the empirical therapy study patients had received chemotherapy for malignancy or had undergone hematopoietic stem-cell transplantation (including 39 allogeneic transplantations).
Icelandic: Sjúklingar í raunvísu meðferðarrannsóknunum höfðu fengið lyfjameðferð við illkynja sjúkdómi (malignancy) eða höfðu gengist undir stofnfrumuígræðslu (þ. á m. 39 ósamgenaígræðslu) til blóðmyndunar.
English: Caspofungin did not increase the plasma levels of cyclosporin.
Icelandic: Caspófúngín jók ekki blóðþéttni cíklósporína.
English: An initial 70 mg loading dose should be administered on Day-1.
Icelandic: Hefja á meðferð með 70 mg hleðsluskammti á fyrsta degi.
English: • Blurred vision, increase in tears, swollen eyelid, yellowing of the whites of the eyes
Icelandic: Þokusýn, aukin táramyndun, bólgin augnlok, gulnun hvítu augans
English: However, variability was seen in both C1 hr (Day 4 geometric mean 11.73 µg/mL, range 2.63 to 22.05 µg/mL) and C24 hr (Day 4 geometric mean 3.55 µg/mL, range 0.13 to 7.17 µg/mL).
Icelandic: (Á fjórða degi var rúmfræðilegt miðgildi 11,73 µg/ml, bil 2,63 til 22,05 µg/ml) og C24 klst.
English: Sodium hydroxide (to adjust the pH)
Icelandic: Natríumhýdroxíð (til jöfnunar á sýrustigi)
English: Also reported in patients with invasive aspergillosis were pulmonary oedema, adult respiratory distress syndrome (ARDS), and radiographic infiltrates.
Icelandic: Einnig hefur verið greint frá lungnabjúg, andnauðarheilkenni hjá fullorðnum (adult respiratory distress syndrome, ARDS) og lungnaíferð á lungnamynd hjá sjúklingum með ífarandi Aspergillus sveppasýkingu.
English: 35 mg for moderate hepatic impairment (from one 70 mg vial)
Icelandic: 35 mg vegna miðlungsmikillar skerðingar á lifrarstarfsemi (úr einu 70 mg hettuglasi)
English: DO NOT USE ANY DILUENTS CONTAINING GLUCOSE, as Caspofungin Accord is not stable in diluents containing glucose.
Icelandic: EKKI MÁ NOTA ÞYNNINGARLAUSNIR SEM INNIHALDA GLÚKÓSA þar sem CASPOFUNGIN ACCORD er ekki stöðugt í lausnum sem innihalda glúkósa.
English: No dosage adjustment is necessary based on renal impairment (see section 5.2).
Icelandic: Aðlögun skammta er ekki nauðsynleg m.t.t. skertrar nýrnastarfsemi (sjá kafla 5.2).
English: An independent expert panel determined that 41 % (26/63) of patients receiving at least one dose of caspofungin had a favourable response.
Icelandic: Óháður hópur sérfræðinga mat að 41% (26/63) sjúklinganna sem fengu a.m.k.
English: the caspofungin plasma AUC0-24 hr was generally comparable to that seen in adults receiving caspofungin at 50 mg daily.
Icelandic: caspófúngíns í blóði almennt sambærilegt við það sem sást hjá fullorðnum sem fengu 50 mg daglegan caspófúngín skammt.
English: People who might get this type of infection include those who have just had an operation or those whose immune systems are weak.
Icelandic: Þeir einstaklingar sem geta átt á hættu að fá þessa tegund sýkingar eru m.a. þeir sem hafa nýlega gengist undir skurðaðgerð og þeir sem eru með veiklað ónæmiskerfi.
English: • Empirical therapy for presumed fungal infections (such as Candida or Aspergillus) in febrile,
Icelandic: Raunvís meðferð (empirical therapy) á áætluðum sveppasýkingum (svo sem Candida eða Aspergillus) hjá fullorðnum sjúklingum eða hjá börnum með hita og daufkyrningafæð (neutropaenic).
English: The white to off-white compact lyophilised powder will dissolve completely.
Icelandic: Hvíta eða beinhvíta, þétta, frostþurrkaða duftið leysist fullkomlega upp.
English: • Catheter site pain, injection site complaints (redness, hard lump, pain, swelling, irritation, rash, hives, leaking of fluid from the catheter into the tissue), inflammation of vein at injection site
Icelandic: Verkur við æðalegg, kvartanir vegna einkenna á stungustað (roði, harður hnútur, verkur, bólga, erting, útbrot, ofsakláði, leki vökva úr æðalegg í vefinn) bláæðarbólga við innrennslisstað
English: Aseptically transfer this volume (mL)c of reconstituted Caspofungin Accord to an IV bag
Icelandic: Annar valkostur, bæta má rúmmálinu (ml)c af stofnlausn Caspofungin Accord í minna magn af
English: For adult patients with mild hepaticimpairment (Child-Pugh score 5 to 6), no dosage adjustment is needed.
Icelandic: Engin skammtaaðlögun er nauðsynleg hjá fullorðnum með vægt skerta lifrarstarfsem (Child-Pugh gildi 5 til 6).
English: Accord
Icelandic: UNDIRBÚNINGUR
English: Caspofungin Accord 70 mg powder for concentrate caspofungin
Icelandic: Caspofungin Accord 70 mg þykknisstofn caspófúngín i.v.
English: Each vial of Caspofungin Accord contains 50 mg or 70 mg of caspofungin (as acetate).
Icelandic: 50 mg eða 70 mg af caspófúngíni (sem asetat).
English: Nervous system disorders headache dizziness, dysgeusia, paraesthesia, somnolence, tremor, hypoaesthesia
Icelandic: Taugakerfi höfuðverkur sundl, bragðtruflun, náladofi, svefndrungi, skjálfti, snertiskynsminnkun
English: • Chills, fever
Icelandic: Kuldahrollur, hiti
English: • Chills
Icelandic: (kg)
English: 35 mg for moderate hepatic impairment (from one 50 mg vial)
Icelandic: 35 mg, vegna miðlungsmikillar skerðingar á lifrarstarfsemi (úr einu 50 mg hettuglasi)
English: Caspofungin is extensively bound to albumin.
Icelandic: Caspófúngín er að mestu leyti bundið albúmíni.
English: • Belly pain, upper belly pain, bloating, constipation, difficulty swallowing, dry mouth, indigestion, passing gas, stomach discomfort, swelling due to build-up of fluid around the belly
Icelandic: Magaverkur, verkur í efri hluta maga, uppþemba, hægðatregða, kyngingarerfiðleikar, munnþurrkur, meltingartruflanir, vindgangur, óþægindi í maga, þroti vegna vökvasöfnunar umhverfis maga
English: Caspofungin Accord 50 mg powder for concentrate caspofungin
Icelandic: Caspofungin Accord 50 mg þykknisstofn caspófúngín i.v.
English: cholestasis, hepatomegaly, hyperbilirubinaemia, jaundice, hepatic function abnormal, hepatotoxicity, liver disorder, gamma-glutamyltransferase increased
Icelandic: gallteppa, lifrarstækkun, gallrauðadreyri (hyperbilirubinaemia) gula, óeðlileg lifrarstarfssemi, lifrareiturvirkni, lifrarröskun, hækkun á gammaglútamýltransferasa
English: An increase in the incidence of cervical ribs was also noted.
Icelandic: Auk þess varð aukning á myndun hálsrifja.
English: INSTRUCTIONS FOR USE IN PAEDIATRIC PATIENTS (Caspofungin Accord 50 mg)
Icelandic: LEIÐBEININGAR FYRIR NOTKUN HJÁ BÖRNUM (Caspofungin Accord 50 mg)
English: INSTRUCTIONS FOR USE IN PAEDIATRIC PATIENTS (Caspofungin Accord 70 mg)
Icelandic: LEIÐBEININGAR FYRIR NOTKUN HJÁ BÖRNUM (Caspofungin Accord 70 mg)
English: Mannitol
Icelandic: algengar
English: • Loss of kidney function, sudden loss of kidney function
Icelandic: Skerðing á nýrnastarfssemi, skyndileg skerðing á nýrnastarfsemi
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each vial contains: 70 mg caspofungin(as acetate).
Icelandic: Hvert hettuglas inniheldur 70 mg caspófúngín (sem asetat).
English: When co-administering inducers of metabolic enzymes, an increase in the daily dose of caspofungin to 70 mg, following the 70 mg loading dose, should be considered in adult patients (see section 4.2).
Icelandic: Íhuga ætti gjöf 70 mg skammts af caspófúngíni á dag, eftir gjöf 70 mg hleðsluskammts, þegar um samhliða gjöf metabólískra ensímörva er að ræða hjá fullorðnum sjúklingum (sjá kafla 4.2).
English: There is no clinical experience in adults with severe hepatic impairment or in paediatric patients with any degree of hepatic impairment.
Icelandic: Engin klínísk reynsla er fyrir hendi hjá fullorðnum hvað varðar verulega skerðingu á lifrarstarfsemi eða hjá börnum með hvers konar skerðingu á lifrarstarfsemi.
English: Favourable response rates in neutropaenic patients were 7/14 (50 %) in the caspofungin group and 4/10 (40 %) in the amphotericin B group.
Icelandic: Jákvætt svörunarhlutfall hjá sjúklingum með daufkyrningafæð var 7/14 (50%) hjá hópnum sem fékk caspófúngín og 4/10 (40%) hjá hópnum sem fékk amfóterisín B. Frekari stuðningur við þessar takmörkuðu rannsóknarniðurstöður kom í ljós með niðurstöðum rannsóknarinnar á raunvísri meðferð.
English: What Caspofungin Accord contains
Icelandic: Caspofungin Accord inniheldur
English: Blood and lymphatic system disorders haemoglobin decreased, haematocrit decreased, white blood cell count decreased anaemia, thrombocytopaenia, coagulopathy, leukopaenia, eosinophil count increased, platelet count decreased, platelet count increased, lymphocyte count decreased, white blood cell count increased, neutrophil count decreased
Icelandic: Blóð og eitlar minnkaður blóðrauði, lækkað blóðkornahlutfall, fækkun hvítra blóðfrumna blóðleysi, blóðflagnafæð, storkukvilli, hvítfrumnafæð, fjölgun eósínófíkla, fækkun blóðflagna, fjölgun blóðflagna, fækkun eitilfrumna, fjölgun hvítra blóðfrumna, fækkun daufkyrninga
English: In a retrospective study of 40 patients treated during marketed use with caspofungin and cyclosporin for 1 to 290 days (median 17.5 days), no serious hepatic adverse reactions were noted.
Icelandic: Engar alvarlegar aukaverkanir komu fram á lifur í afturvirkri rannsókn á 40 sjúklingum sem meðhöndlaðir voru í 1 til 290 daga (miðgildi 17,5 dagar) með caspófúngíni og cíklósporínum þegar lyfið var komið á markað.
English: b. Visually inspect the reconstituted solution for particulate matter or discolouration during reconstitution and prior to infusion.
Icelandic: Skoðið stofnlausnina vandlega með tilliti til agna eða óeðlilegs litar á meðan blöndun stendur og áður en til innrennslis kemur.
English: To reconstitute the powder bring the vial to room temperature and aseptically add 10.5 mL of water for injection.
Icelandic: Þegar blanda skal lyfjaduftið skal láta hettuglasið ná stofuhita áður en bætt er í það með smitgát 10,5 ml af vatni til inndælingar.
English: Musculoskeletal and connective tissue disorders arthralgia back pain, pain in extremity, bone pain, muscular weakness, myalgia
Icelandic: Stoðkerfi og stoðvefur liðverkir bakverkur, verkur í útlimum, beinverkur, máttleysi í vöðvum, vöðvaþrautir.
English: A reduction of the daily dose to 35 mg is recommended for adults with moderate hepatic impairment.
Icelandic: Mælt er með minnkun á dagsskammtinum hjá fullorðnum í 35 mg þegar um miðlungsmikla skerðingu á lifrarstarfsemi er að ræða.
English: 35 mg for moderate hepatic impairment (from one 50 mg vial) at reduced volume
Icelandic: 35 mg vegna miðlungsmikillar skerðingar á lifrarstarfsemi (úr einu 50 mg hettuglasi) minna rúmmál
English: Aseptically transfer this volume (mL)c of reconstituted Caspofungin
Icelandic: Flytjið, með smitgát, rúmmálið (ml)c af blandaðri stofnlausn Caspofungin
English: Respiratory, thoracic and mediastinal disorders dyspnoea nasal congestion, pharyngolaryngeal pain, tachypnoea, bronchospasm, cough, dyspnoea paroxysmal nocturnal, hypoxia, rales, wheezing
Icelandic: mæði nefstífla, verkur í koki og barkakýli, hraðöndun, berkjukrampi, hósti, mæði sem kemur fram í svefni (paroxymal nocturnal), vefildisskortur, hrygl, más
English: Determine the actual loading dose to be used in the paediatric patient by using the patient's BSA (as calculated above) and the following equation:
Icelandic: Ákvarðið hleðsluskammt sem nota á hjá barninu með því að nota BSA barnsins (reiknað skv. formúlu hér að ofan) og eftirfarandi jöfnu:
English: Do not mix with diluents containing glucose, as Caspofungin Accord is not stable in diluents containing glucose.
Icelandic: Lyfið má ekki blanda þynningarlausnum sem innihalda glúkósa því Caspofungin Accord er ekki stöðugt í þynningarlausnum sem innihalda glúkósa.
English: c. Caspofungin Accord is formulated to provide the full labelled vial dose (70 mg) when 10 mL is withdrawn from the vial.
Icelandic: c.Caspofungin Accord er framleitt þannig að það gefur þann skammt sem er á merkimiða hettuglassins (70 mg) þegar 10 ml eru dregnir úr hettuglasinu.
English: Preparation of the 50 mg/m2 infusion for paediatric patients >3 months of age (using a 50-mg vial)
Icelandic: Undirbúningur á 50 mg/ m2 blöndu fyrir barn > 3ja mánaða (notkun 50 mg hettuglass)
English: Caspofungin trough levels gradually decreased upon repeated administration.
Icelandic: Lágstyrkur caspófúngíns (trough levels) stigminnkaði við endurtekna lyfjagjöf.
English: Elimination
Icelandic: Upplausn
English: Reconstitution of Caspofungin Accord
Icelandic: Upplýsingar um Caspofungin Accord
English: Preparation of the 70 mg/m2 infusion for paediatric patients > 3 months of age (using a 70-mg vial)
Icelandic: Undirbúningur á 70 mg/m2 blöndu fyrir barn > 3ja mánaða (notkun 70 mg hettuglass)
English: Please tell your doctor, nurse or pharmacist if you are taking, have recently taken or might take any other medicines.
Icelandic: Leitið til læknisins, hjúkrunarfræðingsins eða lyfjafræðings ef þörf er á frekari upplýsingum um notkun lyfsins.
English: White to off-white, powder.
Icelandic: Hvítt til beinhvítt, þétt duft.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each vial contains: 50 mg caspofungin (as acetate)
Icelandic: Hvert hettuglas inniheldur 50 mg caspófúngín (sem asetat).
English: In limited clinical experience, resistance to caspofungin in patients with invasive aspergillosis has been observed.
Icelandic: Vart hefur orðið við myndun ónæmis fyrir caspófúngíni hjá sjúklingum með ífarandi Aspergillosis sveppasýkingu en klínísk reynsla er takmörkuð.
English: c Caspofungin Accord is formulated to provide the full labeled vial dose (50 mg) when 10 mL is withdrawn from the vial.
Icelandic: c. Caspofungin Accord er framleitt þannig að það gefur þann skammt sem er á merkimiða hettuglassins (50 mg) þegar 10 ml eru dregnir úr hettuglasinu
English: Aseptically transfer this volume (mL)c of reconstituted Caspofungin Accord to an IV bag (or bottle) containing 250 mL of 0.9 %, 0.45 %, or 0.225 % Sodium Chloride solution for infusion or Lactated Ringers solution for infusion.
Icelandic: Flytjið, með smitgát, rúmmálið (ml)c af stofnlausn Caspofungin Accord yfir í innrennslispoka (eða flösku) sem inniheldur 250 ml af 0,9%, 0,45% eða 0,225% natríumklóríði innrennslislausn eða Ringer Lactat innrennslislausn.
English: Preparation of the 70 mg/m2 infusion for paediatric patients >3 months of age (using a 50-mg vial)
Icelandic: Undirbúningur á 70 mg/m2 blöndu fyrir barn > 3ja mánaða (notkun 50 mg hettuglass)
English: Hepatobiliary disorders elevated liver enzyme levels (AST, ALT)
Icelandic: Lifur og gall hækkuð gildi lifrarensíma (ASAT, ALAT)
English: In paediatric patients, results from regression analyses of pharmacokinetic data suggest that co-administration of dexamethasone with caspofungin may result in clinically meaningful reductions in caspofungin trough concentrations.
Icelandic: Niðurstöður frá rannsókn á lyfjahvörfum með aðhvarfsgreiningu, benda til þess að samhliða gjöf dexametasón ásamt caspófúngíni leiði til klínískt marktækrar lækkunar á lágmarks styrk caspófúngíns.
English: Fever and chills that do not respond to an antibiotic are the most common signs of this type of infection.
Icelandic: Algengustu einkenni þessar tegundar sýkingar eru hiti og kuldahrollur sem gengur ekki til baka við sýklalyfjameðferð.
English: How to store Caspofungin Accord
Icelandic: Hvernig geyma á Caspofungin Accord
English: dose, the AUC0-24 hr was somewhat higher.
Icelandic: var AUC 0 - 24klst.
English: Remove the volume of medicine equal to the calculated daily maintenance dose (Step 1) from the vial.
Icelandic: Mælið rúmmál lyfsins sem var reiknað út í skrefi 1og takið úr hettuglasinu, þ.e. daglega viðhaldsskammtinn.
English: Caspofungin Accord 70 mg powder for concentrate for solution for infusion Each vial contains 70 mg caspofungin (as acetate).
Icelandic: HEITI LYFS Caspofungin Accord 70 mg stofn fyrir innrennslisþykkni, lausn caspófúngín VIRK(T) EFNI Hvert hettuglas inniheldur:
English: • Headache
Icelandic: Hiti
English: 7.2 mg/mL.
Icelandic: 7,2 mg/ml í hettuglasinu.
English: Remove the volume of medicine equal to the calculated loading dose (Step 1) from the vial.
Icelandic: Mælið rúmmál lyfsins sem er jafnt hleðsluskammtinum sem var reiknaður út í skrefi 1 og takið úr hettuglasinu.
English: Caspofungin displays moderate non-linear pharmacokinetics with increased accumulation as the dose is increased, and a dose dependency in the time to reach steady state upon multiple-dose administration.
Icelandic: Lyfjahvörf caspófúngíns eru meðalhröð og ólínuleg og aukin uppsöfnun á sér stað þegar skammtarnir eru stækkaðir.
English: Pharmacokinetic data from one 10-month old child receiving the 50 mg/m2 daily dose indicated an AUC0-24 hr within the same range as that observed in older children and adults at the 50 mg/m2 and the 50 mg dose, respectively, while in one 6-month old child receiving the 50 mg/m2
Icelandic: Upplýsingar um lyfjahvörf fyrir eitt 10 mánaða gamalt barn sem fékk 50 mg/m2 einu sinni á dag gáfu til kynna AUC 0 - 24klst.
English: Eye disorders ocular icterus, vision blurred, eyelid oedema, lacrimation increased
Icelandic: Augu gula í augum, þokusýn, bjúgur á augnloki, aukin táraseyting
English: Cardiac disorders palpitations, tachycardia, arrhythmia, atrial fibrillation, cardiac failure congestive
Icelandic: Hjarta hjartsláttarónot, hraðtaktur, hjartsláttartruflun, gáttatif, hjartabilun
English: Plasma concentrations of caspofungin decline in a polyphasic manner following single 1-hour intravenous infusions.
Icelandic: Þegar einn skammtur caspófúngíns er gefinn í æð á einni klukkustund, lækkar blóðþéttni þess í fleiri en einu þrepi.
English: Very common
Icelandic: Mjög
English: Equilibrate the refrigerated vial of Caspofungin Accord to room temperature.
Icelandic: Látið kælda Caspofungin Accord hettuglasið ná stofuhita.
English: Skin and subcutaneous tissue disorders rash, pruritus, erythema, hyperhidrosis erythema multiforme, rash macular, rash maculo-papular, rash pruritic, urticaria, dermatitis allergic, pruritus generalised, rash erythematous, rash generalised, rash morbilliform, skin lesion
Icelandic: Húð og undirhúð útbrot, kláði, roðaþot, ofsviti regnbogaroði, dröfnuútbrot, dröfnuörðuútbrot, kláðaútbrot, ofsakláði, ofnæmis húðbólga, almennur kláði, roðaþotsútbrot, almenn útbrot, útbrot sem líkjast mislingaútbrotum (rash morbilliform), húðskemmdir eitrunardrep í húðþekju og StevensJohnson heilkenni (sjá kafla 4.4)
English: • The other ingredients are sucrose, mannitol, succinic acid and sodium hydroxide (please see section 2.
Icelandic: Súkrósi, mannitól, rafsýra og natríumhýdroxíð (vinsamlegast lesið kafla 2 „Áður en byrjað er að nota Caspofungin Accord“).
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Caspofungin Accord 50 mg powder for concentrate for solution for infusion Each vial contains 50 mg caspofungin (as acetate).
Icelandic: HEITI LYFS Caspofungin Accord 50 mg stofn fyrir innrennslisþykkni, lausn caspófúngín VIRK(T) EFNI Hvert hettuglas inniheldur:
English: Pregnancy
Icelandic: Liðverkir
English: Accord to an IV bag (or bottle) containing 250 mL of 0.9 %, 0.45 %, or 0.225 % Sodium Chloride solution for infusion, or Lactated Ringers solution for infusion.
Icelandic: Accord yfir í innrennslispoka (eða flösku) sem inniheldur 250 ml af 0,9%, 0,45% eða 0,225% natríumklóríði innrennslislausn eða Ringer Lactat innrennslislausn.
English: Step 2 Addition of reconstituted Caspofungin Accord to patient infusion solution Diluents for the final solution for infusion are: sodium chloride solution for injection 9 mg/mL, or lactated Ringer's solution should be used.
Icelandic: Nota skal natríumklóríðlausn 9 mg/ml til inndælingar eða Ringers laktat lausn.
English: However, paediatric patients probably have a different adverse event profile compared to adult patients.
Icelandic: Hinsvegar er líklegt að aukaverkanamynstur barna sé frábrugðið því sem gerist hjá fullorðnum.
English: Alternatively, the volume (mL)c of reconstituted Caspofungin Accord can be added to a reduced volume of 0.9 %,
Icelandic: Annar valkostur, bæta má rúmmálinu (ml)c af stofnlausn Caspofungin Accord í minna magn af 0,9%, 0,45% eða 0,225%
English: Gastrointestinal disorders nausea, diarrhoea, vomiting abdominal pain, abdominal pain upper, dry mouth, dyspepsia, stomach discomfort, abdominal distension, ascites, constipation, dysphagia, flatulence
Icelandic: Meltingarfæri ógleði, niðurgangur, uppköst kviðverkur, kviðverkur í efri hluta, munnþurrkur, meltingatruflanir, óþægindi í maga, þaninn magi, vökvasöfnun í kviðarholi, hægðatregða, kyngingartregða, vindgangur