FrancophonIA/ELRC3.0 huggingface dataset:
English: The European Medicines Agency has waived the obligation to submit the results of studies with rituximab in all subsets of the paediatric population with follicular lymphoma.
Icelandic: Lyfjastofnun Evrópu hefur fallið frá kröfu um að lagðar verði fram niðurstöður úr rannsóknum á rítúxímab hjá öllum undirhópum barna við hnútóttu eitilfrumukrabbameini.
English: There is a peel-off sticker on the glass vial that specifies the medication.
Icelandic: Á hettuglasinu er límmiði með upplýsingum um lyfið, sem hægt er að fjarlægja.
English: (q3m) µg/mL
Icelandic: Margfeldismeðaltal Ctrough (q3m) µg/ml
English: This analysis suggests that dose adjustment of MabThera with any of the tested covariates is not expected to result in a meaningful reduction in its pharmacokinetic variability.
Icelandic: MabThera skammta að einhverri þeirra skýribreyta (covariates) sem prófaðar voru sé ekki talin draga úr breytileika lyfjahvarfa svo nokkru nemi.
English: • Allergic reactions including wheezing or shortness of breath, swelling of the face and tongue,
Icelandic: Ofnæmisviðbrögð svo sem sog- eða blísturshljóð við öndun, andnauð, bólga í andliti og á tungu, yfirlið.
English: Based on popPK analysis an absolute bioavailability of 71% was estimated.
Icelandic: Á grundvelli þýðisgreiningar á lyfjahvörfum var algert aðgengi lyfsins metið 71%.
English: Malignancies
Icelandic: Taugakvillar
English: Table 3 Treatment of relapsed/refractory chronic lymphocytic leukaemia -overview of efficacy results for MabThera plus FC vs. FC alone (25.3 months median observation time) Efficacy Parameter
Icelandic: Tafla 3 Meðferð við langvinnu eitilfrumuhvítblæði þar sem sjúkdómurinn hafði tekið sig upp á ný eða svaraði ekki meðferð - yfirlit yfir niðurstöður varðandi verkun fyrir MabThera ásamt FC borið saman við FC eitt sér (miðgildislengd eftirfylgnitíma 25,3 mánuðir)
English: MARKETING AUTHORISATION NUMBER(S) EU/1/98/067/002
Icelandic: MARKAÐSLEYFISNÚMER EU/1/98/067/002
English: Table 4 Adverse drug reactions occurring in ≥ 5% of patients receiving MabThera for maintenance treatment of GPA and MPA, and at a higher frequency than the comparator group
Icelandic: 5% sjúklinga sem fengu viðhaldsmeðferð með MabThera við hnúðaæðabólgu og smásærri fjölæðabólgu, og með hærri tíðni en samanburðarhópurinn Líffæraflokkur Aukaverkun1
English: Relapsed/Refractory follicular lymphoma
Icelandic: Dreifing/Brotthvarf
English: What MabThera contains
Icelandic: MabThera inniheldur
English: Very rare side effects (may affect up to 1 in 10, 000 people):
Icelandic: Aukaverkanir sem koma örsjaldan fyrir (hjá allt að 1 af hverjum 10.000 einstaklingum):
English: PR
Icelandic: d)
English: MabThera 500 mg concentrate for solution for infusion Clear Type I glass vials with butyl rubber stopper containing 500 mg of rituximab in 50 mL.
Icelandic: I með bútýl gúmmítappa sem innihalda 500 mg af rítúxímabi í 50 ml.
English: The information provided in this section pertains to the use of MabThera in oncology.
Icelandic: Upplýsingarnar í þessum kafla eiga við notkun MabThera til krabbameinslækninga.
English: MabThera subcutaneous
Icelandic: Undirhópar-MabThera einlyfjameðferð
English: Efficacy outcomes in MabThera treated patients were analysed based on autoantibody status prior to commencing treatment.
Icelandic: MabThera voru greindar eftir stöðu sjálfsmótefna fyrir meðferð.
English: Non-oncology indications:
Icelandic: Meðal einkenna PML eru:
English: Your doctor will check if you should have any vaccines before you receive MabThera.
Icelandic: Læknirinn mun athuga með bólusetningar fyrir meðferð með MabThera.
English: Summary of the safety profile
Icelandic: Áhættuhlutfall öryggismörk)
English: MabThera is used for the treatment of patients with moderate to severe pemphigus vulgaris.
Icelandic: MabThera er notað til meðferðar sjúklinga með miðlungi alvarlega eða alvarlega langvinna blöðrusótt.
English: MabThera intravenous
Icelandic: Hnútótt eitilæxli
English: MARKETING AUTHORISATION NUMBER(S) EU/1/98/067/004
Icelandic: MARKAÐSLEYFISNÚMER EU/1/98/067/004
English: Localised candida infections as well as Herpes zoster were reported at a higher incidence in the MabThera-containing arm of randomised studies.
Icelandic: Fleiri tilkynningar bárust um staðbundnar hvítsveppasýkingar og ristil hjá þeim hópi sem fékk MabThera í slembiröðuðu rannsóknunum.
English: • being sick (vomiting), diarrhoea, pain in the stomach, irritation or ulcers in the throat and mouth, problems swallowing, constipation, indigestion
Icelandic: • uppköst, niðurgangur, kviðverkir, erting eða sáramyndun í hálsi og munni,
English: MabThera 1400 mg solution for subcutaneous injection rituximab
Icelandic: MabThera 1400 mg stungulyf, lausn, til notkunar undir húð rítúxímab
English: Infections and Infestations upper respiratory tract infection, urinary tract infections
Icelandic: Sýking í efri hluta öndunarvegar, þvagfærasýkingar
English: Disease-free survivala
Icelandic: Lifun án versnunar sjúkdóms
English: MabThera monotherapy is indicated for treatment of patients with stage III-IV follicular lymphoma who are chemoresistant or are in their second or subsequent relapse after chemotherapy.
Icelandic: MabThera einlyfjameðferð er ætlað til meðferðar hjá sjúklingum með hnútótt eitilfumukrabbamein á III.
English: MabThera 100 mg concentrate for solution for infusion Clear Type I glass vials with butyl rubber stopper containing 100 mg of rituximab in 10 mL.
Icelandic: I með bútýl gúmmítappa sem innihalda 100 mg af rítúxímabi í 10 ml.
English: MabThera treatment.
Icelandic: MabThera eftir markaðssetningu lyfsins.
English: Cases of hepatitis B reactivation have been reported in subjects receiving MabThera including fulminant hepatitis with fatal outcome.
Icelandic: Tilkynnt hefur verið um fá tilfelli endurvirkjunar lifrarbólgu B, sem sum leiddu til dauða, hjá sjúklingum með hnúðaæðabólgu eða smásæja fjölæðabólgu sem fengu
English: MARKETING AUTHORISATION NUMBER(S) EU/1/98/067/001
Icelandic: MARKAÐSLEYFISNÚMER EU/1/98/067/001
English: Product information Physician information Patient information Patient Alert card
Icelandic: Samantekt á eiginleikum lyfs Fræðsluefni fyrir lækna Fræðsluefni fyrir sjúklinga
English: NAME OF THE MEDICINAL PRODUCT MabThera 1600 mg solution for subcutaneous injection
Icelandic: HEITI LYFS MabThera 1600 mg stungulyf, lausn, til notkunar undir húð.
English: Cases of hepatitis B reactivation, including those with a fatal outcome, have been reported in rheumatoid arthritis, granulomatosis with polyangiitis and microscopic polyangiitis patients receiving MabThera.
Icelandic: B, sem sum leiddu til dauða, hjá einstaklingum með iktsýki, hnúðaæðabólgu og smásæja fjölæðabólgu sem fengu MabThera.
English: • you have a weak immune system.
Icelandic: • starfsemi ónæmiskerfis þíns er skert.
English: Erosion score
Icelandic: Svörunarhlutfall fyrir greiningu
English: First infusion
Icelandic: Síðari innrennsli
English: Subgroup analysis PFS
Icelandic: stigs rannsókn fengu
English: No patients in the MabThera arm had fatal adverse events.
Icelandic: Engar banvænar aukaverkanir komu fram hjá sjúklingum í hópnum sem fékk MabThera.
English: • After aseptic dilution in D-glucose solution
Icelandic: Eftir þynningu í D-glúkósalausn að viðhafðri smitgát
English: At 24 months, estimates for overall survival were 68.2% in the R-CHOP arm compared to 57.4% in the CHOP arm. A subsequent analysis of the duration of overall survival, carried out with a median follow-up duration of 60 months, confirmed the benefit of R-CHOP over CHOP treatment (p=0.0071), representing a risk reduction of
Icelandic: Síðari greining á lengd lifunar, þar sem miðgildislengd eftirfylgni var 60 mánuðir, staðfesti ávinning af R-CHOP fram yfir CHOP meðferð (p=0,0071) og kom þar fram að áhætta minnkaði um 32%.
English: • feeling sick (nausea)
Icelandic: Verkur við þvaglát (sýking í þvagrás)
English: There is no evidence of dysmorphogenesis (i.e. teratogenesis) resulting from systemic exposure to rHuPH20.
Icelandic: Engar vísbendingar liggja fyrir um vansköpun vegna almennrar útsetningar fyrir rHuPH20.
English: Hypogammaglobulinaemia
Icelandic: Meltingarsjúkdómar
English: Patients should be observed for at least 15 minutes following MabThera subcutaneous administration.
Icelandic: 15 mínútur eftir gjöf MabThera undir húð.
English: Patients who have ever had hepatitis B infection will be carefully checked by their doctor for signs of this infection
Icelandic: Læknirinn mun fylgjast vel með einkennum um slíka sýkingu hjá sjúklingum með sögu um lifrarbólgu
English: Similarly, the geometric mean AUC (CV%) values at Cycle 6 were higher among the subcutaneous group than the intravenous group; 4088 µg•day/mL (34.2) versus 3630 µg•day/mL (32.8) respectively) with a resulting adjusted geometric mean ratio [90% CI] of 1.10 [0.98-1.24].
Icelandic: (34,2) borið saman við 3.630 µg•dag/ml (32,8) respectively og leiðrétt hlutfall margfeldismeðaltala [90% öryggismörk] var því 1,10 [0,98-1,24].
English: A course of MabThera consists of two 1000 mg intravenous infusions.
Icelandic: Meðferðarlota með MabThera felst í 1000 mg innrennsli í bláæð tvisvar sinnum.
English: Monotherapy
Icelandic: L-histidín
English: The European Medicines Agency has waived the obligation to submit the results of studies with MabThera in all subsets of the paediatric population with autoimmune arthritis.
Icelandic: Lyfjastofnun Evrópu hefur fallið frá kröfu um að lagðar verði fram niðurstöður úr rannsóknum á rítúxímab hjá öllum undirhópum barna við langvinnu eitilfrumuhvítblæði.
English: The recommended dose of MabThera subcutaneous formulation used as a maintenance treatment for patients with relapsed/refractory follicular lymphoma who have responded to induction treatment is: 1400 mg once every 3 months (starting 3 months after the last dose of induction therapy) until disease progression or for a maximum period of two years (8 administrations in total).
Icelandic: 375 mg/m líkamsyfirborðs einu sinni á 3 mánaða fresti (byrjað 3 mánuðum eftir síðasta skammt innleiðslumeðferðar) fram að versnun sjúkdóms eða að hámarki í tvö ár (alls 8 innrennsli).
English: In SAWYER (BO25341), severe administration-related reactions (Grade ≥3) were reported in four patients (5%) following MabThera subcutaneous administration.
Icelandic: Í SAWYER-rannsókninni (BO25341) var tilkynnt um alvarleg viðbrögð sem tengdust lyfjagjöf
English: For retreatment with MabThera monotherapy for patients who have responded to previous treatment with MabThera monotherapy for relapsed/refractory follicular lymphoma, the recommended dose is: 375 mg/m2 body surface area, administered as an intravenous infusion once weekly for four weeks
Icelandic: Fyrir endurmeðferð með MabThera einlyfjameðferð hjá sjúklingum sem hafa svarað fyrri MabThera einlyfjameðferð fyrir endurkomið/þrálátt hnútótt eitilfrumukrabbamein er ráðlagður skammtur:
English: NAME OF THE MEDICINAL PRODUCT MabThera 1400 mg solution for subcutaneous injection
Icelandic: HEITI LYFS MabThera 1400 mg stungulyf, lausn, til notkunar undir húð.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/98/067/003
Icelandic: MARKAÐSLEYFISNÚMER EU/1/98/067/003
English: What you need to know before you use MabThera
Icelandic: Áður en byrjað er að nota MabThera
English: PML, reactivation of hepatitis B
Icelandic: • endurvirkjun lifrarbólgu B.
English: (see section 5.1).
Icelandic: Sjá frekari upplýsingar í kafla 5.1
English: cells/μL after two weekly infusions of rituximab 375 mg/m2, and remained at that level in most patients up to the 6 month timepoint.
Icelandic: Hjá sjúklingum með hnúðaæðabólgu eða smásæja fjölæðabólgu fækkaði B-eitilfrumum í útæðablóði í <10 frumur/µl eftir tvö innrennsli 375 mg/m2 af rítúximabi með viku millibili og hélst þannig hjá flestum sjúklingum í 6 mánuði.
English: The pharmacokinetic profile of MabThera when administered as 6 infusions of 375 mg/m2 in combination with 6 cycles of CHOP chemotherapy was similar to that seen with MabThera alone.
Icelandic: Þegar MabThera var gefið sem 375 mg/m2 innrennsli 6 sinnum ásamt 6 lotum af CHOP
English: MabThera is indicated in adults in combination with chemotherapy for the treatment of patients with previously untreated and relapsed/refractory chronic lymphocytic leukaemia (CLL).
Icelandic: MabThera er ætlað til notkunar ásamt krabbameinslyfjum til meðferðar fullorðinna sjúklinga við áður ómeðhöndluðu langvinnu eitilfrumuhvítblæði sem hefur tekið sig upp á ný eða svarar ekki meðferð.
English: Cardiovascular adverse reactions
Icelandic: Aukaverkanir frá taugakerfi
English: Blood and lymphatic system disorders neutropenia, leucopenia, +febrile neutropenia, +thrombocyt openia anaemia, +pancytopenia, +granulocytopeni a coagulation disorders, aplastic anaemia, haemolytic anaemia, lymphadenopa thy transient increase in serum IgM levels3
Icelandic: Blóð og eitlar Daufkyrningafæð, hvítfrumnafæð, +daufkyrningafæð með sótthita, +blóðflagnafæ ð
English: System Organ Class Adverse drug reaction
Icelandic: 14. AFGREIÐSLUTILHÖGUN Lyfseðilsskylt lyf
English: Hypogammaglobulinaemia (IgG or IgM below the lower limit of normal) has been observed in RA patients treated with MabThera.
Icelandic: Lág þéttni gammaglóbúlína (IgG eða IgM undir lægri mörkum eðlilegra gilda) hefur sést hjá sjúklingum með iktsýki sem fengið hafa MabThera.
English: Consultation with a Neurologist should be considered as clinically indicated.
Icelandic: Íhuga skal að leita álits hjá sérfræðingi í taugasjúkdómum ef talin er ástæða til út frá klínískum einkennum.
English: • Place all used needles and syringes into a sharps container (puncture-proof disposable container).
Icelandic: Setja á allar notaðar nálar og sprautur í þar til gerð nálarheld ílát til förgunar.
English: In patients with relapsed/refractory CLL, the incidence of grade 3/4 hepatitis B infection (reactivation and primary infection) was 2% in R-FC vs 0% in FC.
Icelandic: B veiru (endurvirkjun og frumkomin sýking) 2% í R-FC hópnum en 0% í FC hópnum.
English: What MabThera 1600 mg solution for subcutaneous injection looks like and contents of the pack
Icelandic: MabThera 1600 mg stungulyf, lausn, til notkunar undir húð og pakkningastærðir
English: Table 8: Distribution/Elimination - Pharmacokinetic parameters of MabThera subcutaneous compared to MabThera intravenous Trial BP22333 (SparkThera) Geometric mean Ctrough
Icelandic: Dreifing/Brotthvarf - samanburður á lyfjahvarfabreytum fyrir MabThera stungulyf undir húð og MabThera innrennslislyf í bláæð
English: The use of MabThera subcutaneous formulation as monotherapy in patients with stage III-IV follicular lymphoma who are chemoresistant or are in their second or subsequent relapse after chemotherapy cannot be recommended as the safety of the once weekly subcutaneous administration has not been established.
Icelandic: -IV. stigi, sem svara ekki krabbameinslyfjameðferð eða hafa fengið tvær eða fleiri endurkomur sjúkdómsins eftir krabbameinslyfjameðferð, þar sem ekki hefur verið sýnt fram á öryggi notkunar stungulyfs undir húð einu sinni í viku.
English: Skin and subcutaneous tissue disorders pruritis, rash, +alopecia urticaria, sweating, night sweats, +skin disorder severe bullous skin reactions, Stevens-Johns on Syndrome toxic epidermal necrolysis (Lyell's Syndrome) 7
Icelandic: Alvarleg blöðrumyndun í húð, StevensJohnson heilkenni eitrunardreplos húðþekju (Lyells heilkenni)7
English: • tumour pain
Icelandic: • hjartabilun
English: Nervous system disorders headache paraesthesia, migraine, dizziness, sciatica
Icelandic: kyngingarerfiðleikar, hægðatregða, meltingartruflanir
English: Absorption parameters of subcutaneous formulation, decreased with increasing BMI.
Icelandic: Breytur fyrir frásog lyfs sem gefið er undir húð lækkuðu með auknum líkamsþyngdarstuðli (BMI).
English: For patients who may be at higher risk for relapse, physicians should consider a longer duration of MabThera maintenance therapy, up to 5 years.
Icelandic: Læknar ættu að íhuga að halda viðhaldsmeðferð með MabThera lengur áfram, í allt að 5 ár, hjá sjúklingum sem eru í aukinni hættu á bakslagi.
English: The recommended dose of MabThera subcutaneous formulation used as a maintenance treatment for patients with previously untreated follicular lymphoma who have responded to induction treatment is: 1400 mg once every 2 months (starting 2 months after the last dose of induction therapy) until disease progression or for a maximum period of two years (12 administrations in total).
Icelandic: 1400 mg einu sinni á 2 mánaða fresti (byrjað 2 mánuðum eftir síðasta skammt innleiðslumeðferðar) fram að versnun sjúkdóms eða að hámarki í tvö ár (alls 12 innrennsli).
English: Most common local cutaneous reactions were injection site erythema (26%), injection site pain (16%), and injection site swelling (5%).Two patients in SAWYER trial who experienced Grade 3 local cutaneous reactions (injection site erythema, injection site pain and injection site swelling).
Icelandic: Algengustu staðbundnu viðbrögð í húð voru hörundsroði á stungustað (26%), verkur á stungustað (16%) og þroti á stungustað (5%).
English: Gastrointestin al disorders nausea vomiting , diarrhoea, abdominal pain, dysphagia, stomatitis, constipation, dyspepsia, anorexia, throat irritation abdominal enlargement gastro-intestin al perforation7
Icelandic: Uppköst, niðurgangur, kviðverkir, kyngingartregða, munnbólga, hægðatregða, meltingartruflanir, lystarleysi, erting í hálsi
English: For information related to the other indications, please refer to the SmPC of MabThera intravenous formulation.
Icelandic: Upplýsingar sem eiga við aðrar ábendingar er að finna í samantekt á eiginleikum lyfs fyrir MabThera innrennslislyf til notkunar í bláæð.
English: PATIENT ALERT CARD TEXT FOR NON-ONCOLOGY INDICATIONS MabThera Alert Card for patients with non-oncology diseases
Icelandic: MabThera öryggiskort fyrir sjúklinga með aðra sjúkdóma en krabbamein
English: BATCH NUMBER
Icelandic: Tafla 17
English: Duration of response* Disease free survival (DFS)** Time to new treatment
Icelandic: - Tími fram að versnun sjúkdóms eða dauða (Time to progression or death) PFS - Lifun án sjúkdómsversnunar (Progression-Free Survival) TTF - Tími framað því að meðferð brást
English: Posology
Icelandic: Verkunarviðmiðun
English: MabThera at a fixed dose of 1600 mg was administered for 5 cycles subcutaneously at 4-weekly intervals, following the first cycle of MabThera intravenous formulation, in previously untreated CLL patients in combination with chemotherapy (fludarabine and cyclophosphamide (FC).
Icelandic: Sjúklingum með langvinnt eitilfrumuhvítblæði sem ekki höfðu áður fengið meðferð og þar sem sjúkdómurinn hafði tekið sig upp á ný eða svaraði ekki meðferð var gefið MabThera í föstum 1.600 mg skömmtum undir húð, ásamt krabbameinslyfjum (flúdarabíni og cýklófosfamíði, FC) í 5 meðferðarlotur með 4 vikna millibili, eftir fyrstu meðferðarlotu með MabThera í æð.
English: Bronchospasm4, respiratory disease, chest pain, dyspnoea, increased cough, rhinitis asthma, bronchiolitis obliterans, lung disorder, hypoxia interstitial lung disease7
Icelandic: Astmi, djúpkvefsstífla , lungnasjúkdómur, súrefnisskortur í vefjum (hypoxia)
English: What MabThera is and what it is used for What you need to know before you are given MabThera How MabThera is given
Icelandic: Áður en byrjað er að nota MabThera Ekki má gefa þér MabThera
English: Table 6 Summary of key results from four phase III randomised studies evaluating the benefit of MabThera with different chemotherapy regimens in follicular lymphoma
Icelandic: stigs, slembiröðuðum rannsóknum þar sem metinn var ávinningur af MabThera með mismunandi krabbameinslyfjameðferðaráætlunum við hnútóttu eitilfrumukrabbameini Rannsókn Meðferð, n
English: 2) Last tumour response as assessed by the investigator.
Icelandic: Mat var reiknað út frá áhættuhlutfalli 2) Síðasta æxlissvörun skv. mati rannsóknaraðila.
English: Severe IRRs with fatal outcome have been reported in the post-marketing setting.
Icelandic: Tilkynnt hefur verið um alvarleg innsrennslistengd viðbrögð sem leitt hafa til dauða eftir markaðssetningu lyfsins.
English: At that time, and within a maximum of 1 month after the last cyclophosphamide pulse, patients were randomly assigned to receive either MabThera (two 500 mg IV infusions separated by two weeks (on Day 1 and Day 15) followed by 500 mg IV every 6 months for
Icelandic: MabThera (tvö 500 mg innrennsli í bláæð með tveggja vikna millibili (á degi 1 og degi 15) sem fylgt var eftir með 500 mg innrennsli í bláæð á 6 mánaða fresti í 18 mánuði) eða azathíóprín (til inntöku í skömmtum sem námu
English: CRRa
Icelandic: Liðverkur
English: The most frequently observed adverse drug reactions (ADRs) in patients receiving MabThera were infusion-related reactions which occurred in the majority of patients during the first infusion.
Icelandic: Ávinningur hvað varðar lifun fram að versnun sjúkdóms kom fram hjá flestum undirhópum sjúklinga sem rannsakaðir voru í samræmi við sjúkdómshættu við upphaf rannsóknar.
English: 90 (3x30) tablets (multipack)
Icelandic: 90 (3x30) töflur (fjölpakkning)
English: MA (EU) number (Invented) name Strength Pharmaceutical Form Route of Administration Immediate Packaging Pack size EU/1/15/1068/001 Wakix
Icelandic: (Sér)heiti Styrkleiki Lyfjaform Íkomuleið Innri umbúðir
English: Radiopharmaceutical precursor, solution vial (glass) 1 to 3 ml
Icelandic: 1 til 3 ml
English: Content (concentration)
Icelandic: hettuglas (gler)
English: Your doctor or nurse should have discussed this with you previously.
Icelandic: Læknirinn eða hjúkrunarfræðingur ætti að hafa rætt um þetta við þig áður.
English: Do not stop Apidra without speaking to a doctor, who will tell you what needs to be done.
Icelandic: Ekki hætta að nota Apidra án samráðs við lækni, sem segir þér hvað þurfi að gera.
English: Your doctor will show you in which area of the skin you should inject Apidra.
Icelandic: Læknirinn mun sýna þér á hvaða húðsvæði þú átt að sprauta Apidra.
English: Tel: 800 13 12 12 (domande di tipo tecnico) 800 536389 (altre domande)
Icelandic: 800 13 12 12 (domande di tipo tecnico) 800 536389 (altre domande)
English: If you have to mix two types of insulin
Icelandic: Ef þú þarft að blanda saman tveimur tegundum af insúlíni
English: These reactions are usually transitory and normally they disappear during continued treatment.
Icelandic: Þessar verkanir eru venjulega tímabundnar og hverfa oftast við áframhaldandi meðferð.
English: The Apidra SoloStar is blue.
Icelandic: Apidra SoloStar er blár.
English: These are serious side effects.
Icelandic: Þetta eru alvarlegar aukaverkanir.
English: If you experience the following symptoms, contact your doctor immediately:
Icelandic: Ef þú verður vör/var við eftirfarandi einkenni skaltu hafa samband við lækninn strax:
English: Your doctor has decided that SoloStar is appropriate for you based on your ability to handle SoloStar.
Icelandic: Læknir hefur ákveðið að SoloStar henti þér byggt á getu þinni til að meðhöndla SoloStar.
English: Adjustment of dose may be also necessary if patients undertake increased physical activity or change their usual meal plan.
Icelandic: Einnig getur verið nauðsynlegt að breyta skammti ef sjúklingar auka líkamlegt erfiði eða ef þeir breyta venjulegu mataræði sínu.
English: The average body mass index (BMI) of patients was 34.55 kg/m2.
Icelandic: Líkamsþyngdarstuðull (BMI) sjúklinganna var að meðaltali 34,55 kg/m2.
English: The outer and inner needle caps should be removed.
Icelandic: Ytri og innri nálarhetturnar á að fjarlægja.
English: It has a rapid onset within 10-20 minutes and a short duration, about 4 hours.
Icelandic: Verkun þess hefst skjótt á innan við 10-20 mínútum og varir stutt, í um 4 klst.
English: Glucose must also be given intravenously, if the patient does not respond to glucagon within 10 to 15 minutes.
Icelandic: Einnig á að gefa glúkósa í bláæð ef sjúklingurinn hefur ekki svarað glúkagoni innan 10 til 15 mínútna.
English: You may need to use Apidra with syringes or pens.
Icelandic: Þú gætir þurft að nota Apidra í sprautu eða penna.
English: Apidra with alcohol
Icelandic: Notkun Apidra með áfengi
English: ATC code: A10AB06
Icelandic: A10AB06