FrancophonIA/ELRC3.0 huggingface dataset:
English: Gastrointestinal haemorrhage (inc mucosal)*, Abdominal distension, Dyspepsia, Oropharyngeal pain*, Gastritis*, Oral ulceration*, Abdominal discomfort, Dysphagia, Gastrointestinal inflammation*, Abdominal pain (inc gastrointestinal and splenic pain)*, Oral disorder*
Danish: fra slimhinde)*, abdominal distension, dyspepsi, orofaryngeale smerter*, gastritis*, mundsår*, abdominalt ubehag, dysfagi, gastrointestinal inflammation*, abdominalsmerter (inkl.
English: Bortezomib Accord 1 mg powder for solution for injection Type 1 glass 6 ml-vial with a grey chlorobutyl stopper and an aluminium seal, with a blue cap containing 1 mg bortezomib.
Danish: Bortezomib Accord 1 mg pulver til injektion, opløsning 6 ml hætteglas i type 1 glas med en grå chlorobutyl-prop og en aluminiumsforsegling med blåt låg, der indeholder 1 mg bortezomib.
English: a Intent to Treat (ITT) population b p-value from the stratified log-rank test; analysis by line of therapy excludes stratification for therapeutic history; p <
Danish: a Intent to Treat (ITT) population b p-værdi fra den stratificerede log-rank test; analyse ud fra behandling udelukker opdeling på tidligere behandling; p < 0,0001 c Responspopulation omfatter patienter, som havde målbar sygdom ved baseline og fik mindst
English: Bortezomib Accord 1 mg powder for solution for injection bortezomib
Danish: Bortezomib Accord 1 mg pulver til injektionsvæske, opløsning bortezomib
English: Severity of neuropathy
Danish: Sværhedsgrad af perifer neuropati
English: Uncommon Acute respiratory distress syndrome, Pulmonary embolism, Pneumonitis, Pulmonary hypertension, Pulmonary oedema (inc acute)
Danish: pneumonitis, pulmonal hypertension, lungeødem (inkl.
English: 1 mg
Danish: 1 mg/hætteglas
English: Disseminated intravascular coagulation, Thrombocytosis*, Hyperviscosity syndrome, Platelet disorder NOS, Thrombotic microangiopathy (inc thrombocytopenic purpura) #, Blood disorder NOS, Haemorrhagic diathesis, Lymphocytic infiltration
Danish: Sjælden Dissemineret intravaskulær koagulation, trombocytose*, hyperviskositetssyndrom, uspecificeret påvirkning af trombocytfunktionen, trombotisk mikroangiopati (herunder trombocytopenisk purpura)#, uspecificeret blodsygdom, hæmoragisk diatese, lymfocytinfiltration,
English: Name and address of the manufacturers responsible for batch release Accord Healthcare Ltd
Danish: Navn og adresse på den fremstiller, der er ansvarlig for batchfrigivelse
English: administered twice weekly days 1, 4, 8, and 11, followed by a 17-day rest period from day 12 to day 28), dexamethasone (40 mg administered orally on days 1 to 4 and days 8 to 11), and thalidomide (administered orally at 50 mg daily on days 1-14, increased to 100 mg on days 15-28 and thereafter to 200 mg daily).
Danish: Patienter i BzTDx-gruppen fik seks 4-ugers cyklusser hver med bortezomib (1,3 mg/m2 administreret to gange om ugen dag 1, 4, 8 og 11 efterfulgt af en 17-dages pause fra dag 12 til dag 28), dexamethason (40 mg administreret oralt dag 1 til 4 og dag 8 til 11) og thalidomid (50 mg dagligt administreret oralt dag 1-14, forhøjet til 100 mg dag 15-28 og derefter til 200 mg dagligt).
English: Renal failure acute, Renal failure chronic*, Urinary tract infection*, Urinary tract signs and symptoms*, Haematuria*, Urinary retention, Micturition disorder*, Proteinuria, Azotaemia, Oliguria*, Pollakisuria
Danish: Akut nyresvigt, kronisk nyresvigt*, urinvejsinfektion*, urinvejssymptomer*, hæmaturi*, urinretention, miktionsforstyrrelser*, proteinuri, azotæmi, oliguri*, pollakisuri Sjælden Blæreirritation
English: Bortezomib Accord 1 mg powder for solution for injection is for intravenous use only, while Bortezomib Accord 3.5 mg powder for solution for injection is for intravenous or subcutaneous use.
Danish: Bortezomib Accord 1 mg pulver til injektionsvæske, opløsning, er kun til intravenøs administration, mens Bortezomib Accord 3,5 mg pulver til injektionsvæske, opløsning er til intravenøs eller subkutan anvendelse.
English: Bortezomib Accord 1 mg powder for solution for injection IS FOR INTRAVENOUS USE ONLY, while Bortezomib Accord 3.5 mg powder for solution for injection IS FOR SUBCUTANEOUS OR INTRAVENOUS USE.
Danish: Bortezomib Accord 1 mg pulver til injektionsvæske, opløsning, er kun til intravenøs administration, mens Bortezomib Accord 3,5 mg pulver til injektionsvæske, opløsning, er til intravenøs eller subkutan anvendelse.
English: Pulmonary embolism, Pleural effusion, Pulmonary oedema (inc acute), Pulmonary alveolar haemorrhage#, Bronchospasm, Chronic obstructive pulmonary disease*, Hypoxaemia*, Respiratory tract congestion*, Hypoxia, Pleurisy*, Hiccups, Rhinorrhoea, Dysphonia, Wheezing
Danish: akut), pulmonal alveolær hæmoragi#, bronkospasme, KOL*, hypoksæmi*, luftvejskongestion*, hypoksi, pleuritis*, hikke, rinoré, dysfoni, hvæsende vejrtrækning
English: Motor neuropathy*, Loss of consciousness (inc syncope), Dizziness*, Dysgeusia*, Lethargy, Headache*
Danish: synkope), svimmelhed*, dysgeusi*, letargi, hovedpine*
English: Bortezomib Accord 1 mg powder for solution for injection Each vial contains 1 mg bortezomib (as a mannitol boronic ester).
Danish: Bortezomib Accord 1 mg pulver til injektionsvæske, opløsning Hvert hætteglas indeholder 1 mg bortezomib (som mannitolboronsyreester).
English: Then, Bortezomib Accord may be reinitiated with one dose level reduction (from 1.3 mg/m2 to 1 mg/m2, or from 1 mg/m2 to
Danish: Bortezomib Accord kan så genoptages med et reduceret dosisniveau (fra 1,3 mg/m2 til 1 mg/m2 eller fra 1 mg/m2 til
English: An odds ratio (OR) > 1 indicates an advantage for BzR-CAP. f Include all CR+CRu, by IRC, bone marrow and LDH.
Danish: Inkluderer alle CR + CRu, efter IRC, knoglemarv og LDH.
English: Bortezomib Accord 3.5 mg powder for solution for injection Each carton of Bortezomib Accord 3.5 mg powder for solution for injection contains a glass 10 ml vial with a grey chlorobutyl rubber stopper and aluminium seal, with a red cap.
Danish: Hver pakning Bortezomib Accord 3,5 mg pulver til injektionsvæske, opløsning, indeholder et 10 ml hætteglas med en grå chlorobutol-gummiprop og aluminiumsforsegling med en rød hætte.
English: What Bortezomib Accord is and what it is used for What you need to know before you use Bortezomib Accord How to use Bortezomib Accord Possible side effects
Danish: Det skal du vide, før du begynder at bruge Bortezomib Accord Sådan skal du bruge Bortezomib Accord Bivirkninger
English: • In cycles 1 to 4, Bortezomib Accord is administered twice weekly on days 1, 4, 8, 11, 22, 25, 29
Danish: - I cyklus 1 til 4 gives Bortezomib Accord to gange om ugen på dag 1, 4, 8, 11, 22, 25, 29 og 32.
English: Bortezomib Accord 1 mg powder for solution for injection Each carton of Bortezomib Accord 1 mg powder for solution for injection contains a glass 6 ml vial with a grey chlorobutyl rubber stopper and aluminium seal, with a blue cap, containing 1 mg of bortezomib.
Danish: Hver pakning Bortezomib Accord 1 mg pulver til injektionsvæske, opløsning, indeholder et 6 ml hætteglas med en grå chlorobutol-gummiprop og aluminiumsforsegling med en blå hætte, der indeholder 1 mg bortezomib.
English: Medianc(95% CI) (months) Response rate n: response-evaluable patients 229
Danish: Responsrate n:respons-evaluerbare patienter
English: - if you are allergic to bortezomib, boron or to any of the other ingredients of this medicine (listed in section 6) - if you have certain severe lung or heart problems.
Danish: - hvis du er allergisk over for bortezomib, bor eller et af de øvrige indholdsstoffer i Bortezomib
English: The safety profile of bortezomib in 240 MCL patients treated with bortezomib at 1.3 mg/m2 in combination with rituximab, cyclophosphamide, doxorubicin, and prednisone (BzR-CAP) versus 242 patients treated with rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone [R-CHOP] was relatively consistent to that observed in patients with multiple myeloma with main differences described below.
Danish: kontra 242 patienter behandlet med rituximab, cyclophosphamid, doxorubicin, vincristin og prednison [R-CHOP] var relativt overensstemmende med den, som blev observeret hos patienter med myelomatose, med de væsentligste forskelle beskrevet nedenfor.
English: Each vial contains 3.5 mg bortezomib (as a mannitol boronic ester).
Danish: Hvert hætteglas indeholder 3,5 mg bortezomib (som mannitolboromsyreester).
English: Bortezomib Accord 3.5 mg powder for solution for injection IS FOR SUBCUTANEOUS OR INTRAVENOUS USE.
Danish: Bortezomib Accord 3,5 mg pulver til injektionsvæske, opløsning ER BEREGNET TIL SUBKUTAN ELLER INTRAVENØS ANVENDELSE.
English: • Paralysis, seizures, falling, movement disorders, abnormal or change in, or reduced sensation
Danish: synstab eller -forstyrrelser og kortåndethed - hukommelsestab, nedsat tankevirksomhed, gangbesvær eller synstab.
English: > 1.0 x −1.5 x ULN Any
Danish: > 1,0-1,5 x ULN
English: Bortezomib Accord 3.5 mg powder for solution for injection Each 10 ml vial of Bortezomib Accord must be carefully reconstituted with 3.5 ml of sodium chloride 9 mg/ml (0.9%) solution for injection, by using a syringe of the appropriate size, without removing the vial stopper.
Danish: Bortezomib Accord 3,5 mg pulver til injektion, opløsning Hvert 10 ml hætteglas med Bortezomib Accord rekonstitueres forsigtigt med 3,5 ml natriumchlorid 9 mg/ml (0,9 %) injektionsvæske, opløsning ved hjælp af en sprøjte af passende størrelse og uden at fjerne proppen fra hætteglasset.
English: Bortezomib Accord 1 mg powder for solution for injection Each 6 ml vial of Bortezomib Accord must be carefully reconstituted with 1 ml of sodium chloride 9 mg/ml (0.9%) solution for injection, by using a syringe of the appropriate size, without removing the vial stopper.
Danish: Bortezomib Accord 1 mg pulver til injektion, opløsning Hvert 6 ml hætteglas med Bortezomib Accord rekonstitueres forsigtigt med 1 ml natriumchlorid 9 mg/ml (0,9 %) injektionsvæske, opløsning ved hjælp af en sprøjte af passende størrelse og uden at fjerne proppen fra hætteglasset.
English: SN:
Danish: LDH.
English: Bortezomib Accord 3.5 mg powder for solution for injection Each 10 ml vial of Bortezomib Accord must be carefully reconstituted with 1.4 ml of sodium chloride 9 mg/ml (0.9%) solution for injection, by using a syringe of the appropriate size, without removing the vial stopper.
Danish: Bortezomib Accord 3,5 mg pulver til injektion, opløsning Hvert 10 ml hætteglas med Bortezomib Accord rekonstitueres forsigtigt med 1,4 ml natriumchlorid 9 mg/ml (0,9 %) injektionsvæske ved hjælp af en sprøjte af passsende størrelse og uden at fjerne proppen fra hætteglasset.
English: Very Common Neuropathies*, Peripheral sensory neuropathy, Dysaesthesia*, Neuralgia*
Danish: Neuropati*, perifer sensorisk neuropati, dysæstesi*, neuralgi* Almindelig Motorisk neuropati*, bevidsthedstab (inkl.
English: • Skin infections
Danish: Vaskulære sygdomme
English: A Phase II, single arm activity, safety, and pharmacokinetic trial conducted by the Children's Oncology Group assessed the activity of the addition of bortezomib to multi agent re induction
Danish: Et fase II-forsøg med en enkelt arm vedrørende aktivitet, sikkerhed og farmakokinetik udført af Children's Oncology Group vurderede virkningen af at tilføje bortezomib til reinduktionskemoterapi med flere stoffer hos pædiatriske og unge voksne patienter med lymfoid malignitet (akut præ-B-celle lymfoblastær leukæmi [ALL], T-celle ALL og T-celle lymfoblastært lymfom [LL]).
English: N=240 (ITT population) N=242 (ITT population)
Danish: N=242 (ITT-population)
English: Muscle spasms*, Pain in extremity, Muscular weakness
Danish: Almindelig Muskelspasmer*, ekstremitetssmerter, muskelsvaghed Ikke almindelig
English: Bortezomib Accord is administered via intravenous or subcutaneous injection at the recommended dose of 1.3 mg/m2 body surface area twice weekly for two weeks on days 1, 4, 8, and 11, followed by a 10-day rest period on days 12-21.
Danish: Bortezomib Accord 3,5 mg pulver til injektionsvæske, opløsning administreres via intravenøs eller subkutan injektion i den anbefalede dosis på 1,3 mg/m2 legemsoverfladeareal to gange om ugen i to uger på dag 1, 4, 8 og 11, efterfulgt af en 10-dages hvileperiode dag 12-21.
English: Tremor, Peripheral sensorimotor neuropathy, Dyskinesia*, Cerebellar coordination and balance disturbances*, Memory loss (exc dementia)*, Encephalopathy*, Posterior Reversible Encephalopathy Syndrome#, Neurotoxicity, Seizure disorders*, Post herpetic neuralgia, Speech disorder*, Restless legs syndrome, Migraine, Sciatica, Disturbance in attention, Reflexes abnormal*, Parosmia
Danish: demens)*, encefalopati*, posteriort reversibelt encefalopatisk syndrom#, neurotoksicitet, epileptiske anfald*, postherpetisk neuralgi, taleforstyrrelser*, restless legssyndrom, migræne, skiatika, opmærksomhedsforstyrrelser, abnorme reflekser*, parosmi
English: Hypokalaemia*, Blood glucose abnormal*, Hyponatraemia*, Diabetes mellitus*, Fluid retention Uncommon Tumour lysis syndrome
Danish: Almindelig Hypokaliæmi*, unormal blodglucose*, hyponatriæmi*, diabetes mellitus*, væskeretention
English: Discontinue Bortezomib Accord
Danish: Indstil Bortezomib Accord-behandlingen
English: restlessness or agitation, changes in your mental status, disorientation
Danish: rastløshed eller ophidselse, ændringer i sindstilstand, desorientering - Hævelser på kroppen, inklusive omkring øjnene og andre steder på kroppen
English: Neuropathies*, Motor neuropathy*, Loss of consciousness (inc syncope), Encephalopathy*, Peripheral sensorimotor neuropathy, Dizziness*, Dysgeusia*, Autonomic neuropathy Uncommon Autonomic nervous system imbalance
Danish: synkope), encefalopati*, perifer sensomotorisk neuropati, svimmelhed*, dysgeusi*, autonom neuropati
English: CYTOTOXIC
Danish: Bortezomib
English: CR=Complete Response; CRu=Complete Response unconfirmed; PR=Partial Response; CI=Confidence Interval, HR=Hazard Ratio; OR=Odds Ratio; ITT=Intent to Treat chemotherapy in paediatric and young adult patients with lymphoid malignancies (pre-B cell acute lymphoblastic leukemia [ALL], T-cell ALL, and T-cell lymphoblastic lymphoma [LL]).
Danish: CR=komplet respons; CRu=komplet respons ubekræftet; PR=partielt respons; CI=konfidensinterval, HR=hazard-ratio; OR=oddsratio; ITT= Intent to Treat
English: • Irritated or inflamed eyes, excessively wet eyes, painful eyes, dry eyes, eye infections, lump in the eyelid (chalazion), red and swollen eyelids, discharge from the eyes, abnormal vision,
Danish: overfladisk eller besværet vejrtrækning eller stop i vejrtrækningen, hvæsende vejrtrækning - Blodpropper i lungerne - Gulfarvning af øjne og hud (gulsot) - Haglkorn (en knude i øjenlåget), røde og hævede øjenlåg
English: Pruritus*, Dermatitis*, Rash*
Danish: Hårsygdom* Almindelig Kløe*, dermatitis*, udslæt*
English: Pancreatitis acute, Peritonitis*, Tongue oedema*, Ascites, Oesophagitis, Cheilitis, Faecal incontinence, Anal sphincter atony, Faecaloma*, Gastrointestinal ulceration and perforation*, Gingival hypertrophy, Megacolon, Rectal discharge, Oropharyngeal blistering*, Lip pain, Periodontitis, Anal fissure, Change of bowel habit, Proctalgia, Abnormal faeces
Danish: Clostridium difficile)*, iskæmisk kolitis#, gastrointestinal inflammation*, dysfagi, colon irritabile, uspecificeret sygdom i mave-tarm-kanalen, belagt tunge, forstyrrelser af mave-tarmkanalens funktion*, sygdom i spytkirtlerne* Sjælden Akut pankreatitis, peritonitis*, tungeødem*, ascites, øsofagitis, læbebetændelse, fækal inkontinens, analsfinkteratoni, fækalom*, gastrointestinal ulcus og perforation*, gingival hypertrofi, megacolon, rektalt udflåd, blisterdannelse i hals og svælg*, læbesmerter, parodontitis, analfissur, forandringer i peristaltikken, proktalgi, anormal fæces
English: • Serious allergic reaction (anaphylactic shock) signs of which may include difficulty breathing, chest pain or chest tightness, and/or feeling dizzy/faint, severe itching of the skin or raised lumps on the skin, swelling of the face, lips, tongue and /or throat, which may cause difficulty in swallowing, collapse
Danish: Tegnene på en sådan reaktion kan være vejrtrækningsbesvær, smerter i/trykken for brystet og/eller svimmelhed/følelse af at være ved at besvime, voldsom kløe i huden eller hævede områder på huden, hævelser i ansigt, læber, tunge og/eller svælg, hvilket kan give synkebesvær, kollaps - Bevægelsesforstyrrelser, lammelse, spjætten - Fornemmelse af at snurre eller dreje rundt - Høretab, døvhed - Sygdomme, der påvirker lungerne og forhindrer kroppen i at få nok ilt.
English: Vascular disorders Common
Danish: Almindelig Synsforstyrrelser*
English: Then, Bortezomib Accord may be reinitiated at a dose reduced by one dose level (from 1.3 mg/m2 to 1 mg/m2, or from 1 mg/m2 to 0.7 mg/m2).
Danish: Bortezomib Accord-behandlingen genoptages ved en dosis, som er reduceret med ét dosisniveau (fra 1,3 mg/m2 til 1 mg/m2 eller fra 1 mg/m2 til 0,7 mg/m2).
English: (e.g., bleeding from your bowels, stomach, mouth and gum or bleeding in the brain or bleeding from the liver) - red blood cells, which can cause anaemia, with symptoms such as tiredness and paleness - white blood cells may make you more prone to infections or flu-like symptoms.
Danish: - Følsomhed, følelsesløshed, prikken eller en brændende følelse i huden eller smerter i hænder eller fødder pga. nerveskade - Reduktion i antallet af røde blodlegemer eller hvide blodlegemer (se ovenfor) - Feber - Kvalme og opkastning, nedsat appetit - Forstoppelse med eller uden oppustethed (kan være alvorlig) - Diaré.
English: However, the chemical and physical in-use stability has been demonstrated for 8 hours at 20°C-25°C stored in the original vial and/or a syringe.
Danish: Dog er der vist kemisk og fysisk holdbarhed efter rekonstitution på 8 timer ved 20 -25 oC opbevaret i det originale hætteglas og/eller en sprøjte.
English: Muscle spasms*, Musculoskeletal pain*, Pain in extremity
Danish: Almindelig Muskelspasmer*, muskuloskeletale smerter*,
English: However, the chemical and physical in-use stability has been demonstrated for 3 days at 20°C-25°C stored in the original vial and/or a syringe.
Danish: Dog er der vist kemisk og fysisk holdbarhed efter rekonstitution på 3 dage ved 20 oC -25 oC opbevaret i det originale hætteglas og/eller en sprøjte.
English: Very Common Pneumonia* Common
Danish: Almindelig Vertigo* Ikke almindelig
English: Very Common Hair disorder* Common
Danish: Almindelig Overfølsomhed* Ikke almindelig
English: Cardiac tamponade#, Cardio-pulmonary arrest*, Cardiac fibrillation (inc atrial), Cardiac failure (inc left and right ventricular)*, Arrhythmia*, Tachycardia*, Palpitations, Angina pectoris, Pericarditis (inc pericardial effusion)*, Cardiomyopathy*, Ventricular dysfunction*, Bradycardia
Danish: venstre og højre ventrikel)*, arytmi*, takykardi*, palpitationer, angina pectoris, perikarditis (inkl.
English: Infection*, Bacterial infections*, Viral infections*, Sepsis (inc septic shock)*, Bronchopneumonia, Herpes virus infection*, Meningoencephalitis herpetic#, Bacteraemia (inc staphylococcal), Hordeolum, Influenza, Cellulitis, Device related infection, Skin infection*, Ear infection*, Staphylococcal infection, Tooth infection*
Danish: stafylokok), hordeolum, influenza, cellulitis, udstyrsrelateret infektion, hudinfektion*, øreinfektion*, stafylokokinfektion, tandinfektion*
English: Dex n=336a Bz n=132a
Danish: Dex n=336a
English: Setting (Bortezomib Accord plus dexamethasone, and Bortezomib Accord plus dexamethasone and thalidomide).
Danish: for herved at minimere risikoen for lægmiddel- eller administrationsfejl, der kunne opstå grundet de to forskellige bortezomibkombinationsregimer i transplantationsinduktionsregi (Bortezomib Accord plus dexamethason og Bortezomib Accord plus dexamethason og thalidomid).
English: • Muscle cramps, muscle spasms, muscle weakness, pain in your limbs
Danish: Knogler, led, muskler og bindevæv
English: Your doctor may give you another medicine to control diarrhoea
Danish: Lægen kan give dig medicin til at kontrollere diaréen med - Træthed, svaghed - Muskelsmerter, smerter i knogler
English: • Tiredness, feeling weak
Danish: Pyreksi*, træthed, asteni
English: Bortezomib Accord is administered via intravenous or subcutaneous injection at the recommended dose of 1.3 mg/m2 body surface area twice weekly for two weeks on days 1, 4, 8, and 11 in a 21-day treatment cycle.
Danish: Bortezomib Accord 3,5 mg pulver til injektionsvæske, opløsning administreres via intravenøs eller subkutan injektion i den anbefalede dosis på 1,3 mg/m2 legemsoverfladeareal to gange om ugen i to uger på dag 1, 4, 8 og 11 i en 21-dages behandlingscyklus.
English: Bortezomib Accord is administered via intravenous or subcutaneous injection at the recommended dose of 1.3 mg/m2 body surface area twice weekly for two weeks on days 1, 4, 8, and 11 in a 28-day treatment cycle.
Danish: Bortezomib Accord 3,5 mg pulver til injektionsvæske, opløsning administreres som intravenøs eller subkutan injektion i den anbefalede dosis på 1,3 mg/m2 legemsoverflade to gange om ugen i to uger på dag 1, 4, 8 og 11 i en 28-dages behandlingscyklus.
English: Tabulated list of adverse reactions
Danish: Oversigt over bivirkningerne i tabelform
English: • Weight loss
Danish: Svær nedsættelse
English: • Benign cysts
Danish: cyster og polypper)
English: 1.3 mg/m2, respectively, and ranged from 15 to 32 l/h and 18 to 32 l/h following subsequent doses for doses of 1.0 mg/m2 and 1.3 mg/m2, respectively.
Danish: for doser på henholdsvis 1,0 mg/m2 og 1,3 mg/m2.
English: Dysacusis (inc tinnitus)*,Hearing impaired (up to and inc deafness), Ear discomfort*
Danish: tinnitus)*, nedsat hørelse (inkl.
English: • Drooling
Danish: Amning
English: North Harrow
Danish: Hazard ratiob
English: b b d d b b
Danish: Cyklus 2 - 4b
English: • Low blood pressure, sudden fall of blood pressure on standing which may lead to fainting
Danish: - røde blodlegemer, hvilket kan forårsage blodmangel med symptomer som træthed og bleghed.
English: Rest Period
Danish: -- pause
English: Children and adolescents Do not take this medicine if you are under 18 years of age.
Danish: Børn og teenagere Tag ikke dette lægemiddel hvis du er unger 18 år.
English: • If you have an infection or a fever.
Danish: • Hvis du har en infektion eller feber.
English: • If you have type 1 diabetes.
Danish: • hvis du har type 1-diabetes.
English: Hungary (Headquarters: 4042 Debrecen, Pallagi út 13)
Danish: Ungarn (Hovedkvarter: 4042 Debrecen, Pallagi út 13)
English: • If you eat more than usual.
Danish: • Hvis du spiser mere end normalt.
English: Repaglinide is eliminated rapidly within 4 - 6 hours from the blood.
Danish: Elimination Repaglinid elimineres hurtigt fra blodet indenfor 4-6 timer.
English: The amount of Repaglinide Teva, food or exercise may need to be adjusted.
Danish: Mængden af Repaglinid Teva, mad eller motion skal muligvis justeres.
English: • If you are about to have major surgery or you have recently suffered a severe illness or infection.
Danish: • hvis du står over for en stor operation eller lige har overstået en alvorlig sygdom eller infektion.
English: A small, significant decrease in blood glucose values was observed.
Danish: Der blev observeret et mindre, signifikant fald i blodglucoseværdier.
English: The marketing authorisation holder shall submit periodic safety update reports for this product in accordance with the requirements set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and published on the European medicines web-portal
Danish: Indehaveren af markedsføringstilladelsen skal fremsende PSUR'er for dette lægemidlet i overensstemmelse med kravene på listen over EU-referencedatoer (EURD list), som fastsat i artikel 107c, stk. 7, i direktiv 2001/83/EF og offentliggjort på den europæiske webportal for lægemidler.
English: Repaglinide Teva should be taken with caution.
Danish: Repaglinid Teva skal tages med forsigtighed.
English: • If the acid level in your blood is raised (diabetic ketoacidosis).
Danish: • hvis syreniveauet i dit blod er forhøjet (diabetisk ketoacidose).
English: • have few or no warning signs of hypos.
Danish: • har få eller ingen advarselstegn på hypoglykæmi.