FrancophonIA/ELRC3.0 huggingface dataset:
English: In the paediatric bipolar population (10 - 17 years) with exposure up to 30 weeks, incidence of low serum prolactin levels in females (< 3 ng/ml) and males (< 2 ng/ml) was 28.0% and 53.3%, respectively.
Danish: I den pædiatriske population (10 - 17 år) med bipolær lidelse, som fik behandling i op til 30 uger, var incidensen af lav serum-prolaktin hos piger (< 3 ng/ml) og drenge (< 2 ng/ml) henholdsvis 28,0 % og
English: What Aripiprazole Zentiva is and what it is used for What you need to know before you take Aripiprazole Zentiva How to take Aripiprazole Zentiva Possible side effects
Danish: Det skal du vide, før du begynder at tage Aripiprazole Zentiva Sådan skal du tage Aripiprazole Zentiva Bivirkninger
English: Aripiprazole Zentiva 15 mg tablets
Danish: Aripiprazole Zentiva 15 mg tabletter
English: Vision blurred Diplopia
Danish: Sløret syn Diplopi
English: Aripiprazole Zentiva 10 mg tablets are white to off-white round uncoated tablets with ‘10' debossed on one side and snap tab breakline on the other side with diameter approx. 8 mm.
Danish: Aripiprazole Zentiva 10 mg er hvide til råhvide runde tabletter uden overtræk, præget på den ene side med '10' og snap tab delekærv på den anden side, ca. 8 mm i diameter.
English: Aripiprazole Zentiva 10 mg tablets EU/1/15/1009/006
Danish: Aripiprazole Zentiva 10 mg tabletter EU/1/15/1009/006
English: Aripiprazole Zentiva 5 mg tablets EU/1/15/1009/001
Danish: Aripiprazole Zentiva 5 mg tabletter EU/1/15/1009/001
English: • cardiovascular diseases (diseases of the heart and circulation), family history of cardiovascular disease, stroke or “mini” stroke, abnormal blood pressure
Danish: • hjerte-kar-sygdom (sygdomme i hjertet og kredsløbet), hjerte-kar-sygdom i familien,
English: Aripiprazole Zentiva 15 mg tablets EU/1/15/1009/011
Danish: Aripiprazole Zentiva 15 mg tabletter EU/1/15/1009/011
English: Increased Aspartate Aminotransferase (AST) Increased Gamma Glutamyl Transferase (GGT) Increased alkaline phosphatase
Danish: Forhøjet aspartat-aminotransferase (ASAT)
English: How to store Aripiprazole Zentiva Contents of the pack and other information
Danish: Pakningsstørrelser og yderligere oplysninger Aripiprazole Zentiva indeholder
English: Aripiprazole Zentiva 30 mg tablets
Danish: Aripiprazole Zentiva 30 mg tabletter aripiprazol
English: White to off-white round flat bevel edged uncoated tablets with ‘15' debossed on one side and plain on the other side with diameter approx. 8.8 mm.
Danish: Hvide til råhvide runde, flade tabletter med skrå kant, uden overtræk, præget på den ene side med '15' og uden præg på den anden side, ca. 8,8 mm i diameter.
English: Suicide attempt, suicidal ideation and completed suicide (see section 4.4) Pathological gambling Impulse-control disorders Binge eating
Danish: Selvmordsforsøg, selvmordsforestillinger og gennemførte selvmord (se pkt.
English: Aripiprazole Zentiva 10 mg orodispersible tablets White to off-white round tablets debossed ‘10' on one side and snap break line on other side with diameter approx. 7 mm.
Danish: Aripiprazole Zentiva 10 mg: Hvide til råhvide runde tabletter præget på den ene side med '10' og snap tab delekærv på den anden side, ca. 7 mm i diameter.
English: Aripiprazole Zentiva 15 mg tablets are white to off-white round flat bevel edged uncoated tablets with ‘15' debossed on one side and plain on the other side with diameter approx. 8.8 mm.
Danish: Aripiprazole Zentiva 15 mg er hvide til råhvide runde, flade tabletter med skrå kant, uden overtræk, præget på den ene side med '15' og uden præg på den anden side, ca. 8,8 mm i diameter.
English: Haemodialysis
Danish: Smeltetablet
English: Aripiprazole Zentiva 10 mg orodispersible tablets Aripiprazole Zentiva 15 mg orodispersible tablets Aripiprazole Zentiva 30 mg orodispersible tablets aripiprazole
Danish: Aripiprazole Zentiva 10 mg smeltetabletter Aripiprazole Zentiva 15 mg smeltetabletter Aripiprazole Zentiva 30 mg smeltetabletter
English: Jaundice
Danish: Udslæt
English: Aripiprazole Zentiva 10 mg orodispersible tablets EU/1/15/1009/021
Danish: Aripiprazole Zentiva 10 mg smeltetabletter EU/1/15/1009/021
English: Irritability associated with autistic disorder
Danish: Irritabilitet forbundet med autisme hos pædiatriske patienter (se pkt.
English: NAME OF THE MEDICINAL PRODUCT Aripiprazole Zentiva 10 mg orodispersible tablets Aripiprazole Zentiva 15 mg orodispersible tablets Aripiprazole Zentiva 30 mg orodispersible tablets
Danish: Indlægsseddel: Information til brugeren Aripiprazole Zentiva 10 mg smeltetabletter Aripiprazole Zentiva 15 mg smeltetabletter Aripiprazole Zentiva 30 mg smeltetabletter aripiprazol
English: What Aripiprazole Zentiva looks like and contents of the pack Aripiprazole Zentiva 5 mg are white to off-white round flat bevel edged uncoated tablets with ‘5' debossed on one side and plain on the other side with diameter approx. 6 mm.
Danish: Aripiprazole Zentiva 5 mg er hvide til råhvide runde, flade tabletter med skrå kant og uden overtræk, præget på den ene side med '5' og uden præg på den anden side, ca. 6 mm i diameter.
English: Aripiprazole Zentiva 30 mg orodispersible tablets EU/1/15/1009/027
Danish: Aripiprazole Zentiva 30 mg smeltetabletter EU/1/15/1009/027
English: These medicines may increase the risk of side effects or reduce the effect of Aripiprazole Zentiva; if you get any unusual symptom taking any of these medicines together with Aripiprazole Zentiva, you should see your doctor.
Danish: Disse typer medicin kan øge risikoen for bivirkninger eller reducere virkningen af Aripiprazole Zentiva.
English: Aripiprazole Zentiva 15 mg orodispersible tablets are white to off-white round flat bevel edged tablets debossed ‘15' on one side and plain on the other side with diameter approx. 8 mm.
Danish: Aripiprazole Zentiva 15 mg er hvide til råhvide runde, flade tabletter med skrå kant, præget på den ene side med '15' og uden præg på den anden side, ca. 8 mm i diameter.
English: • difficulty in passing urine;
Danish: • vandladningsproblemer,
English: Aripiprazole Zentiva 15 mg orodispersible tablets EU/1/15/1009/024
Danish: Aripiprazole Zentiva 15 mg smeltetabletter EU/1/15/1009/024
English: Salivary hypersecretion Vomiting
Danish: Dyspepsi Kvalme Øget spytsekretion Opkastning
English: Slovenská republika Zentiva, a.s.
Danish: Zentiva, a.s.
English: paroxetine, venlafaxine, St. John's Wort)
Danish: venlafaxin eller perikon)
English: Diabetes mellitus Hyperglycaemia
Danish: Hyperglykæmi
English: • chest pain,
Danish: • brystsmerter,
English: White to off-white capsule shaped uncoated tablets with ‘30' debossed on one side and snap tab breakline on the other side with dimensions approx. 15.5 x 8 mm.
Danish: Aripiprazole Zentiva 30 mg: Hvide til råhvide kapselformede tabletter uden overtræk, præget på den ene side med '30' og snap tab delekærv på den anden side, størrelse ca. 15,5 x 8 mm.
English: What Aripiprazole Zentiva looks like and contents of the pack Aripiprazole Zentiva 10 mg orodispersible tablets are white to off-white round tablets debossed ‘10' on one side and snap break line on other side with diameter approx. 7 mm.
Danish: Aripiprazole Zentiva 10 mg er hvide til råhvide runde tabletter præget på den ene side med '10' og snap tab delekærv på den anden side, ca. 7 mm i diameter.
English: Aripiprazole Zentiva 30 mg orodispersible tablets
Danish: Aripiprazole Zentiva 30 mg smeltetabletter
English: You should make sure you fully understand and remember the following:
Danish: De skal være sikker på, at De præcis forstår og kan huske følgende:
English: This will give your body a chance to recover.
Danish: Dette vil give Deres krop en chance for at komme sig.
English: • which days are your dosing days.
Danish: • Hvilke dage, der er Deres doseringsdage.
English: Take the capsules on an empty stomach; for example, at least one hour before you plan to eat breakfast.
Danish: Tag kapslerne på tom mave; for eksempel mindst en time før De spiser morgenmad.
English: You may also need other treatments.
Danish: De kan også have behov for en anden behandling.
English: • how many capsules you need to take every dosing day.
Danish: • Hvor mange kapsler De skal tage hver doseringsdag.
English: - if you have ever had or might now have a hepatitis B infection.
Danish: - hvis De nogensinde har haft eller ved at De kan have hepatitis B infektion.
English: Eλλάδα
Danish: Ελλάδα
English: These reactions are classified according to System Organ Class and frequency.
Danish: Disse bivirkninger er klassificeret i henhold til systemorganklasse og hyppighed.
English: Achieving a radiological objective response or maintaining progression-free status was strongly associated with maintained or improved quality of life.
Danish: Opnåelse af radiologisk objektivt respons eller opretholdelse af progressionsfri status var kraftigt forbundet med opretholdt eller forbedret livskvalitet.
English: Once the radiotherapy is completed, you will interrupt treatment for 4 weeks.
Danish: Når strålebehandlingen er færdig, skal De afbryde behandlingen i 4 uger.
English: The use of gloves and aseptic technique is required.
Danish: Det er påkrævet at anvende handsker og aseptiske teknikker.
English: The colour of the capsule cap is different for each strength (see in the table below).
Danish: Farven af kapslen er forskellig for hver styrke (se tabellen nedenfor).
English: Ask your doctor or pharmacist to write it down (including the colour).
Danish: Bed Deres læge eller apotek om at skrive det ned (inklusive farve).
English: Unopened vial: 4 years
Danish: Uåbnet hætteglas: 4 år
English: Review the dose with your doctor each time you start a new cycle, since it may be different from the last cycle.
Danish: Gennemgå doseringen med Deres læge hver gang De starter på en ny cyklus, da det kan være forskelligt fra den sidste cyklus.
English: This latency period is very short even for an alkylating agent.
Danish: Denne latensperiode er meget kort selv for et alkylerende stof.
English: The objective response rate (ORR) based on MRI scans was 8 %.
Danish: Den objektive responsrate (ORR) baseret på MRI scanninger var 8 %.
English: Other side effects that have been reported are listed below:
Danish: Andre indberettede bivirkninger er anført nedenfor:
English: Do not take a double dose to make up for a forgotten dose, unless your doctor tells you to do so.
Danish: De må ikke tage en dobbeltdosis som erstatning for den glemte dosis, medmindre Deres læge beder Dem gøre dette.
English: The intravenous formulation produced local irritation at the site of injection in both rabbits and rats.
Danish: Den intravenøse formulering gav lokal irritation på injektionsstedet hos både kaniner og rotter.
English: These blood cells are important for fighting infection and for proper blood clotting.
Danish: Disse blodceller er vigtige i bekæmpelse af infektioner og for korrekt størkning af blodet.
English: and N
Danish: og N
English: Date of first authorisation: 26 January 1999 Date of latest renewal: 26 January 2009
Danish: Dato for seneste fornyelse: 26. januar 2009.
English: 7 position.
Danish: 7-positionen.
English: Temodal is also available as a hard capsule formulation (oral use).
Danish: Temodal er også tilgængelig som en hård kapselformulering (oral anvendelse).
English: It must not be given by other routes of administration, such as the intrathecal, intramuscular, or subcutaneous route.
Danish: Det må ikke indgives via andre administrationsveje såsom intratekalt, intramuskulært eller subkutant.
English: In some cases, it may be necessary to stop treatment with Temodal.
Danish: I nogle tilfælde kan det være nødvendigt at stoppe behandlingen med Temodal.
English: C elimination is renal.
Danish: C er renal udskillelse.
English: • Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
Danish: • når risikostyringssystemet ændres, særlig som følge af at der er modtaget nye oplysninger, der kan medføre en væsentlig ændring i benefit/risk -forholdet, eller som følge af, at en vigtig milepæl (lægemiddelovervågning eller risikominimering) er nået.
English: Your medicine is given to you by health care professionals.
Danish: Deres medicin indgives af sundhedspersoner.
English: - as you may have a small risk of other changes in blood cells, including leukaemia.
Danish: - da De kan have en lille risiko for andre ændringer i blodcellerne, inklusive leukæmi.
English: Dosage and duration of treatment
Danish: Dosis og varighed af behandlingen
English: However, if you do, the doctor or nurse will treat you accordingly.
Danish: Skulle det alligevel ske, vil lægen eller sygeplejersken behandle Dem i henhold til dette.
English: As it cannot be excluded that the change in Cmax is clinically significant, Temodal should be administered without food.
Danish: Da det ikke kan udelukkes, at ændringen i Cmax er klinisk signifikant, bør Temodal indgives uden føde.
English: In this case, your doctor will also prescribe medicine to help you prevent this type of pneumonia (PCP).
Danish: I dette tilfælde vil Deres læge også udskrive medicin, der kan hjælpe med at forebygge denne form for lungebetændelse (PCP).
English: The irritation was transient and not associated with lasting tissue damage.
Danish: Irritationen var forbigående og ikke associeret med varig vævsskade.
English: Temodal should not be administered to pregnant women.
Danish: Temodal bør ikke anvendes til gravide kvinder.
English: From a microbiological point of view, the product should be used immediately.
Danish: Fra et mikrobiologisk synspunkt bør lægemidlet anvendes umiddelbart efter rekonstitution.
English: • dose level -1 (100 mg/m2) still results in unacceptable toxicity
Danish: • dosistrin -1 (100 mg/m2) fortsat resulterer i uacceptabel toksicitet.
English: a: TMZ dose levels are listed in Table 2. b: TMZ is to be discontinued if:
Danish: a: TMZ dosistrin er anført i Tabel 2. b: TMZ skal seponeres, hvis:
English: In both trials, the primary endpoint was progression-free survival (PFS) defined by MRI scans or neurological worsening.
Danish: I begge undersøgelser var det primære grænsepunkt progressionsfri overlevelse (PFS) defineret ved MRI-scanning eller neurologisk forværring.
English: Your doctor will work out your exact dose.
Danish: Deres læge vil fastsætte Deres eksakte dosis.
English: Tell your pharmacist if you notice any change in the appearance of the capsules.
Danish: Tal med apotekspersonalet, hvis De bemærker et ændret udseende af kapslerne.
English: This is because you must not be treated with Temodal during pregnancy unless clearly indicated by your doctor.
Danish: Det skyldes, at De ikke må behandles med Temodal under graviditet, medmindre det er klart angivet af Deres læge.
English: This is because Temodal could cause hepatitis B to become active again, which can be fatal in some cases.
Danish: Dette skyldes, at Temodal kan forårsage at hepatitis B bliver aktiv igen, hvilket kan være dødeligt i nogle tilfælde.
English: - if you have had an allergic reaction to dacarbazine (an anticancer medicine sometimes called DTIC).
Danish: - hvis De har haft en allergisk reaktion over for dacarbazin (en medicin mod kræft, som også kaldes DTIC).
English: No studies have been conducted to determine the effect of TMZ on the metabolism or elimination of other medicinal products.
Danish: Ingen undersøgelser er udført for at bestemme TMZ's effekt på metabolisering eller elimination af andre lægemidler.
English: A treatment cycle with Temodal lasts 28 days.
Danish: En behandlingscyklus med Temodal varer 28 dage.
English: (total dose per cycle over 5 days) have been evaluated clinically in patients.
Danish: (total dosis pr serie over 5 dage) er blevet vurderet klinisk hos patienter.
English: This daily dose depends on whether or not you have received chemotherapy before.
Danish: Denne daglige dosis afhænger af, om De tidligere har modtaget kemoterapi.
English: Then, you will start the monotherapy phase.
Danish: Derefter vil De påbegynde monoterapi-fasen.
English: Median overall survival was 14.6 months.
Danish: Median samlet overlevelse var 14,6 måneder.
English: During treatment a complete blood count should be obtained weekly.
Danish: Under behandling bør en komplet blodundersøgelse foretages ugentlig.
English: Recurrent anaplastic astrocytoma
Danish: Tilbagevendende anaplastisk astrocytoma
English: The major route of
Danish: Den vigtigste eliminationsvej for
English: This should be taken into consideration by patients on a controlled sodium diet.
Danish: Patienter på en natriumkontrolleret diæt bør tage hensyn hertil.
English: The results from the trial were not consistent in the subgroup of patients with a poor performance status (WHO PS=2, n=70), where overall survival and time to progression were similar in both arms.
Danish: Resultaterne fra undersøgelsen var ikke konsistente i undergruppen af patienter med dårlig præstations status (WHO PS=2, n=70), hvor total overlevelse og tid til progression var ens for de to grupper.
English: Response rate, based on the central reviewer assessment, was 35 % (13 CR and 43 PR) for the intent-to-treat population (ITT) n=162.
Danish: Responsrate, baseret på den centrale reviewers vurdering, var 35 % (13 CR og 43 PR) for intent-to-treat populationen (ITT) n=162.
English: - if you develop fever or symptoms of an infection, contact your doctor immediately.
Danish: - hvis De udvikler feber eller infektionssymptomer, skal De straks kontakte Deres læge.
English: Your doctor will check your blood to make sure you have enough of these cells before you begin treatment.
Danish: Deres læge vil tjekke Deres blod for at sikre, at De har nok af disse celler, før behandlingen påbegyndes.
English: Temodal may make you feel tired or sleepy.
Danish: Når De tager Temodal, kan De føle Dem træt eller søvnig.
English: Most of the toxicity showed evidence of reversibility, except for adverse events on the male reproductive system and retinal degeneration.
Danish: Størstedelen af toksiciteten viste tegn på at være reversibel med undtagelse af bivirkningerne på det mandlige reproduktionssystem og retina degenerationen.
English: Manufacturer: SP Labo N.V., Industriepark 30, B-2220 Heist-op-den-Berg, Belgium
Danish: Fremstiller: SP Labo N.V., Industriepark 30, B-2220 Heist-op-den-Berg, Belgien
English: Depending on the prescribed dose, you may have to take more than one capsule together, eventually with different strengths (content of active substance, in mg).
Danish: Afhængigt af den ordinerede dosis kan det blive nødvendigt at tage mere end én kapsel ad gangennogle gange vil det også være nødvendigt at tage kapsler af forskellig styrke (indhold af aktivt stof i mg).
English: However, because the doses implicated in retinal degeneration were in the lethal dose range, and no comparable effect has been observed in clinical studies, this finding was not considered to have clinical relevance.
Danish: Da de pågældende doser for retina degenerationen imidlertid lå i området for de dødelige doser, og ingen lignende effekt er set i kliniske undersøgelser, blev dette fund ikke betragtet som værende klinisk relevant.
English: Doses of 500, 750, 1,000, and 1,250 mg/m
Danish: Doser på 500, 750, 1.000 og 1.250 mg/m
English: positions of guanine.
Danish: positionerne i guanin.
English: A volume up to 40 ml reconstituted solution should be withdrawn, according to the total prescribed dose and transferred into an empty 250 ml infusion bag (PVC or polyolefin).
Danish: Et volumen på op til 40 ml rekonstitueret opløsning bør udtrækkes i henhold til den totale udskrevne dosis og overføres til en tom 250 ml infusionspose (PVC eller polyolefin).
English: 6 position of guanine with additional alkylation also occurring at the N
Danish: 6-positionen i guanin med ledsagende alkylering ved N
English: There may be a higher occurrence of PCP when TMZ is administered during a longer dosing regimen.
Danish: Der kan være en højere forekomst af PCP, når TMZ anvendes i et længere dosisregime.
English: Temodal treatment can cause a reduction in certain kinds of blood cells.
Danish: Behandling med Temodal kan give et fald i antallet af visse typer blodceller.
English: In this case, do not drive or use any tools or machines or cycle until you see how this medicine affects you (see section 4).
Danish: I så fald, må De ikke køre bil/motorcykel eller cykle eller arbejde med værktøj eller maskiner, før De ved, hvordan dette lægemiddel påvirker Dem (se pkt.
English: Relative to the AUC of TMZ, the exposure to MTIC and AIC is ~ 2.4 % and 23 %, respectively.
Danish: I forhold til AUC af TMZ er eksponeringen til MTIC og AIC henholdsvis ~ 2,4 % og 23 %.
English: Take your prescribed dose of Temodal once a day, preferably at the same time each day.
Danish: Tag Deres ordinerede dosis af Temodal hver dag, helst på samme tidspunkt hver dag.
English: Prior to dosing, the following laboratory parameters must be met: ANC  1.5 x 10
Danish: Forud for dosering skal følgende laboratorieparametre være opfyldte: ANC  1,5 x 10
English: Infections, herpes zoster, pharyngitis a, candidiasis oral
Danish: Infektioner, herpes zoster, faryngitis a, oral candidiasis
English: Depending on your blood test results, your doctor may adjust your dose for the next cycle.
Danish: Afhængig af resultaterne af undersøgelsen af Deres blod vil Deres læge justere dosen til næste cyklus.
English: Anti-emetic prophylaxis is recommended prior to the initial dose of concomitant phase and it is strongly recommended during the monotherapy phase.
Danish: Antiemetisk forebyggelse anbefales før den initiale dosis af den konkomitante fase, og det anbefales kraftigt under monoterapi fasen.
English: Visual acuity reduced, eyes dry
Danish: Nedsat synsskarphed, tørre øjne
English: There were higher rates of Grade 4 neutropenia (ANC < 0.5 x 10
Danish: Der var større hyppighed af Grad 4-neutropeni (ANC < 0,5 x 10
English: The appropriate dose of TMZ should be infused intravenously using a pump over a period of 90 minutes.
Danish: Den passende dosis af TMZ bør indgives intravenøst ved brug af en pumpe over en periode på 90 min.
English: There are reports of patients who have taken the recommended dose for more than 5 days of treatment (up to 64 days) with adverse events reported including bone marrow suppression, with or without infection, in some cases severe and prolonged and resulting in death.
Danish: Der er rapporter på patienter, som har taget den anbefalede dosis i mere end behandlingen på 5 dage (op til 64 dage) med rapporterede bivirkninger, som inkluderede knoglemarvssuppression med eller uden infektion, i nogle tilfælde alvorlige og langvarige og resulterende i dødsfald.
English: CSF penetration was confirmed in one patient; CSF exposure based on AUC of TMZ was approximately 30 % of that in plasma, which is consistent with animal data.
Danish: CSF penetration blev bekræftet hos en patient; CSFeksponering baseret på AUC for TMZ var cirka 30 % i forhold til plasma, hvilket er konsistent med data fra dyr.
English: Opportunistic infection (including PCP), sepsis meningoencephalitis herpetic
Danish: Opportunistiske infektioner (inklusive PCP), sepsis meningoencephalitis herpetica
English: Drug reaction with eosinophilia and systemic symptoms (DRESS)
Danish: Medikamentelt udslæt med eosinofili og systemiske symptomer (DRESS)
English: If you vomit frequently before or during treatment, ask your doctor about the best time to take Temodal until the vomiting is under control.
Danish: Hvis De ofte kaster op før eller under behandlingen, så spørg Deres læge om, hvornår De helst skal tage Temodal, indtil opkastningerne er under kontrol.
English: It is not known whether TMZ is excreted in human milk; thus, breast-feeding should be discontinued while receiving treatment with TMZ.
Danish: Det vides ikke, om TMZ udskilles i human mælk; amning bør derfor afbrydes, under behandling med TMZ.
English: A complete blood count should be obtained on Day 22 (21 days after the first dose) or within 48 hours of that day, and weekly until ANC > 1.5 x 10
Danish: En fuldstændig blodtælling skal foretages på dag 22 (21 dage efter den første dosis) eller inden for 48 timer herefter, og ugentligt indtil ANC > 1,5 x 10