FrancophonIA/ELRC3.0 huggingface dataset:
English: • gastric adenocarcinoma (a stomach cancer) that has spread in patients who have not received any treatment for their cancer.
Danish: • gastrisk adenokarcinom (en form for mavekræft), der har spredt sig hos patienter, der endnu ikke har fået nogen behandling mod deres kræft.
English: Taxotere can only be obtained with a prescription and should only be used in units specialising in giving chemotherapy (medicines to treat cancer) under the supervision of a doctor who is qualified in the use of chemotherapy.
Danish: Taxotere fås kun på recept og bør kun anvendes på afdelinger, der er specialiseret i kemoterapi (lægemidler til behandling af kræft), under opsyn af en læge, der er specialiseret i brug af kemoterapi.
English: How is Taxotere used?
Danish: Hvordan anvendes Taxotere?
English: For the full list of side effects of Taxotere, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger ved Taxotere fremgår af indlægssedlen.
English: What benefits of Taxotere have been shown in studies?
Danish: Hvilke fordele viser studierne, at der er ved Taxotere?
English: It can also be used with cisplatin (another cancer medicine) in patients who have not received any treatment for their cancer;
Danish: Det kan også bruges sammen med cisplatin (et andet kræftmiddel) hos patienter, der endnu ikke har fået nogen behandling for deres kræftsygdom
English: Taxotere is used with prednisone or prednisolone (anti-inflammatory medicines) when the cancer cannot be treated by greatly reducing the body's production of testosterone (castration-resistant prostate cancer).
Danish: Taxotere anvendes sammen med prednison eller prednisolon (antiinflammatoriske lægemidler), når kræften ikke kan behandles ved en kraftig nedsættelse af kroppens dannelse af testosteron (kastrationsresistent prostatatakræft) Det kan også bruges sammen med androgen deprivationsterapi, når hormonterapi stadig virker (hormonfølsom prostatakræft)
English: An anti-inflammatory medicine such as dexamethasone should also be given to the patient, starting on the day before the Taxotere infusion.
Danish: Dagen før infusionen med Taxotere bør patienten endvidere gives et antiinflammatorisk lægemiddel som f.eks. dexamethason.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Taxotere have been included in the summary of product characteristics and the package leaflet.
Danish: Der er anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Taxotere.
English: When used on its own, Taxotere was at least as effective as and sometimes more effective than the comparator medicines in breast cancer, and more effective than best supportive care (any medicines or treatment to help patients, but not other cancer medicines) in lung cancer.
Danish: Ved lungekræft var det mere effektivt end den bedste understøttende behandling (lægemidler eller teknikker til at hjælpe patienterne, men ikke andre kræftmidler).
English: How does Taxotere work?
Danish: Hvordan virker Taxotere?
English: The dose of Taxotere may need to be reduced, or treatment interrupted or discontinued, if the patient develops certain side effects.
Danish: Hvis patienten oplever visse bivirkninger, kan det være nødvendigt at nedsætte dosis af Docetaxel Zentiva eller afbryde eller standse behandlingen.
English: 90 (3x30) tablets (multipack)
Danish: 90 (3x30) tabletter (multipackning)
English: MA (EU) number (Invented) name Strength Pharmaceutical Form Route of Administration Immediate Packaging Pack size EU/1/15/1068/001 Wakix
Danish: MA (EU)-nummer (Opdigtet) navn Styrke Lægemiddelform Administrationsvej
English: Cuprymina 925 MBq/ml
Danish: Cuprymina 925 MBq/ml radiofarmaceutisk mærkningsopløsni ng hætteglas (glas)
English: Radiopharmaceutical precursor, solution vial (glass) 1 to 3 ml
Danish: 1 til 3 ml
English: They will tell you what needs to be done.
Danish: De vil fortælle dig, hvad der er nødvendigt at gøre.
English: It is made by biotechnology.
Danish: Det fremstilles ved hjælp af bioteknologi.
English: The potency of this preparation is stated in units.
Danish: Styrken af dette præparat er angivet i enheder.
English: TIME - hour
Danish: TID - timer
English: These reactions are usually transitory and normally they disappear during continued treatment.
Danish: Disse reaktioner er sædvanligvis forbigående og forsvinder normalt ved fortsat behandling.
English: This should be carried out by healthcare professionals.
Danish: Dette bør udføres af sundhedspersonale.
English: This ensures that you get an accurate dose by:
Danish: Dette sikrer at De får en korrekt dosis ved at:
English: • Contamination and/or infection,
Danish: • kontaminering og/eller infektion.
English: Your doctor or nurse should have discussed this with you previously.
Danish: Din læge eller en sygeplejerske bør på forhånd have gennemgået det med dig.
English: Do not stop Apidra without speaking to a doctor, who will tell you what needs to be done.
Danish: Afbryd ikke behandlingen med Apidra uden at tale med din læge, som vil fortælle dig, hvad der skal gøres.
English: • ensuring that pen and needle work properly
Danish: • sikre at pen og nål virker korrekt
English: Be careful when you start or stop taking another medicine.
Danish: Vær forsigtig, når du begynder eller stopper med at bruge et nyt lægemiddel.
English: If this happens you must seek urgent medical help.
Danish: Hvis dette sker, skal du straks søge lægehjælp.
English: Adjustment of dose may be also necessary if patients undertake increased physical activity or change their usual meal plan.
Danish: Dosisjustering kan også være nødvendig, hvis patienterne øger deres fysiske aktivitet eller ændrer deres sædvanlige kostplan.
English: This means you may not always get enough insulin to treat your diabetes.
Danish: Det betyder, at du måske ikke altid får insulin nok til at behandle din diabetes.
English: Be familiar with your warning symptoms.
Danish: Sørg for at være fortrolig med dine advarselssymptomer.
English: The average body mass index (BMI) of patients was 34.55 kg/m2.
Danish: Patienternes gennemsnitlige body mass index (BMI) var 34,55 kg/m2.
English: Most minor reactions to insulins usually resolve in a few days to a few weeks.
Danish: De fleste mindre alvorlige reaktioner på insulin forsvinder som regel i løbet af et par dage til få uger.
English: Use the pump system recommended by your doctor.
Danish: Brug det pumpesystem din læge anbefaler.
English: These symptoms often develop before the symptoms of a low sugar level in the brain.
Danish: Disse symptomer kommer ofte forud for symptomerne på lavt blodsukker i hjernen.
English: Important information for use of SoloStar:
Danish: Vigtig information vedrørende anvendelse af SoloStar:
English: If you experience the following symptoms, contact your doctor immediately:
Danish: Hvis du får følgende symptomer, skal du straks kontakte din læge:
English: Concomitant oral antidiabetic treatment may need to be adjusted.
Danish: Samtidig behandling med orale antidiabetika skal eventuelt justeres.
English: These injections are justified even if it is not certain that you have hypoglycaemia.
Danish: Det er forsvarligt at give disse injektioner, også selvom det ikke er sikkert, at du har hypoglykæmi.
English: They can also spread around the injection site.
Danish: Disse kan også brede sig til området omkring injektionsstedet.
English: It has a rapid onset within 10-20 minutes and a short duration, about 4 hours.
Danish: Det virker hurtigt inden for 10-20 minutter og virker i ca. 4 timer.
English: Insulin requirements may decrease during the first trimester and generally increase during the second and third trimesters.
Danish: Insulinbehovet kan falde i første trimester og stiger sædvanligvis i andet og tredje trimester.
English: If you are not able to use SoloStar or follow all the instructions completely on your own, you must use SoloStar only if you have help from a person who is able to follow the instructions completely.
Danish: Hvis du ikke på egen hånd er i stand til at følge alle instruktionerne fuldstændig, så brug kun SoloStar, hvis du får hjælp fra en person, som kan følge instruktionerne.
English: This should be kept in mind if treatment with the combination of pioglitazone and Apidra is considered.
Danish: Dette bør tages i betragtning, hvis kombinationsbehandling med pioglitazon og Apidra overvejes.
English: Some medicines cause changes in the blood sugar level (decrease, increase or both depending on the situation).
Danish: Nogle lægemidler kan medføre ændringer i blodsukkeret (få det til at falde, stige eller begge dele afhængig af situationen).
English: The use of other solutions has not been studied.
Danish: Anvendelse af andre opløsninger er ikke undersøgt.
English: Immediately take about 10 to 20 g sugar, such as glucose, sugar cubes or a sugar-sweetened beverage.
Danish: Tag omgående ca. 10-20 g sukker, som f.eks. glucose, hugget sukker eller en sukkersødet drik.
English: Dose proportionality
Danish: Dosisproportionalitet
English: The Apidra SoloStar is blue.
Danish: Apidra SoloStar er blå.
English: Then eat something that has a long-acting effect in raising your blood sugar (such as bread or pasta).
Danish: Spis herefter madvarer med langvarig virkning på dit blodsukker (som f.eks. brød eller pasta).
English: The dose of Apidra should be individually adjusted.
Danish: Dosering af Apidra skal tilpasses individuelt.
English: This may constitute a risk in situations where these abilities are of special importance (e.g. driving a car or operating machines).
Danish: Dette kan udgøre en risiko i situationer, hvor disse evner er af særlig betydning (f.eks. ved bilkørsel eller ved betjening af maskiner).
English: It is essential for patients with pre-existing or gestational diabetes to maintain good metabolic control throughout pregnancy.
Danish: Det er meget vigtigt, at patienter med kendt eller gestational diabetes har en god metabolisk kontrol under hele graviditeten.
English: Based on empirical knowledge from similar medicinal products, clinically relevant pharmacokinetic interactions are unlikely to occur.
Danish: På baggrund af empirisk viden fra tilsvarende lægemidler er det usandsynligt, at der vil forekomme klinisk relevante farmakokinetiske interaktioner.
English: Careful monitoring of glucose control is essential.
Danish: Omhyggelig glucosekontrol er meget vigtig.
English: The frequency of hyperglycaemia cannot be estimated.
Danish: Hyppigheden af hyperglykæmi kan ikke vurderes.
English: Date of latest renewal: 20 August 2009
Danish: Dato for første tilladelse: 27. september 2004 Dato for seneste fornyelse: 20. august 2009
English: Exercise taken immediately after a meal may increase the risk of hypoglycaemia.
Danish: Fysisk aktivitet umiddelbart efter et måltid kan øge risikoen for hypoglykæmi.
English: This is because the insulin may have lost some of its effectiveness.
Danish: Dette kan betyde, at insulinen har mistet noget af effekten.
English: It is important that patients follow the Apidra specific instructions when using Apidra.
Danish: Det er vigtigt, at patienterne følger de Apidra-specifikke instruktioner ved brug af Apidra.
English: Sodium chloride Trometamol
Danish: Natriumchlorid Trometamol
English: • You cannot turn the dosage selector past the number of units left in the pen.
Danish: • Du kan ikke dreje doseringsskalaen forbi antalllet af enheder, der er tilbage i pennen.
English: Apidra can be administered intravenously, which should be carried out by healthcare professionals.
Danish: Apidra kan administreres intravenøst, hvilket skal udføres af sundhedspersonale.
English: On the x-axis, zero (arrow) is the start of a 15-minute meal.
Danish: På x-aksen betegner nul (pilen) starten på et 15 minutters måltid.
English: Apidra should be taken shortly (0-15 minutes) before or soon after meals.
Danish: Apidra skal tages kort tid (0-15 minutter) før eller lige efter måltider.
English: Injection should be given immediately after mixing as no data are available regarding the mixtures made up a significant time before injection.
Danish: Injektionen skal gives umiddelbart efter blanding, da der ikke foreligger data vedrørende blandinger fremstillet et væsentligt stykke tid før injektion.
English: ATC code: A10AB06
Danish: ATC-kode: A10AB06.
English: Injection should be given immediately after mixing.
Danish: Injektionen skal gives umiddelbart efter blanding.
English: In this case, either you can inject what is remaining in the pen and complete your dose with a new SoloStar or use a new SoloStar for your full dose.
Danish: I dette tilfælde kan du enten injicere, det der er tilbage i pennen, og få resten af dosis fra en ny SoloStar eller anvende en ny SoloStar til hele din dosis.
English: Interim subcutaneous injections with Apidra may be required.
Danish: Midlertidige subkutane injektioner med Apidra kan være nødvendige.
English: GLUCOSE - mg/dL
Danish: BLODGLUKOSE - mg/dL
English: After an injection of glucagon, the patient should be monitored in a hospital in order to find the reason for this severe hypoglycaemia and prevent other similar episodes.
Danish: Efter en injektion med glucagon skal patienten observeres på et hospital for at finde årsagen til et sådant svært tilfælde af hypoglykæmi og for at forebygge andre lignende tilfælde.
English: If the combination is used, patients should be observed for signs and symptoms of heart failure, weight gain and oedema.
Danish: Hvis kombinationen anvendes, bør patienterne observeres for tegn og symptomer på hjertesvigt, vægtstigning og ødem.
English: THE FOLLOWING INFORMATION IS INTENDED FOR HEALTHCARE PROFESSIONALS ONLY:
Danish: Nedenstående oplysninger er til læger og sundhedspersonale:
English: Prior to each injection a safety test has to be performed to ensure that pen and needle work properly and to remove air bubbles.
Danish: Før hver injektion skal der udføres en sikkerhedstest for at sikre, at pennen og nålen virker korrekt og for at fjerne luftbobler.
English: Hyperglycaemia (potentially leading to Diabetic ketoacidosis(1))
Danish: Hyperglykæmi (kan potentielt medføre diabetisk ketoacidose(1))
English: Special care before injection
Danish: Specielle forholdsregler før injektion
English: Follow closely the instructions for dose, monitoring (blood tests), diet and physical activity (physical work and exercise) as discussed with your doctor.
Danish: Overhold nøje anvisningerne vedrørende dosering, kontrollerne (blodprøver), kostplan og den fysiske aktivitet (fysisk arbejde og motion), som er aftalt med lægen.
English: Cold insulin is more painful to inject.
Danish: Kold insulin er mere smertefuldt at injicere.
English: Keep this possible problem in mind in all situations where you might put yourself and others at risk (such as driving a car or using machines).
Danish: Vær opmærksom på dette mulige problem i alle situationer, hvor du kan bringe dig selv eller andre i fare (som f.eks. ved bilkørsel eller ved betjening af maskiner).
English: A dose of 2 units has to be selected.
Danish: En dosis på 2 enheder vælges.
English: The outer and inner needle caps should be removed.
Danish: Ydre og indre nålekapsel skal fjernes.
English: Studies on pharmacokinetic interactions have not been performed.
Danish: Der er ikke udført farmakokinetiske interaktionsstudier.
English: Pen needle (not included)
Danish: Nål til pen (ikke inkluderet)
English: Figure 1: Average glucose-lowering effect over 6 hours in 20 patients with type 1 diabetes mellitus.
Danish: Figur 1: Gennemsnitlig glucosesænkende effekt i løbet af 6 timer hos 20 patienter med type 1 diabetes mellitus.
English: Severe hyperglycaemia or ketoacidosis must always be treated by a doctor, normally in a hospital.
Danish: Alvorlig hyperglykæmi eller ketoacidose skal altid behandles af en læge, og det foregår normalt under hospitalsindlæggelse.
English: These are serious side effects.
Danish: Disse bivirkninger er alvorlige.
English: This can be serious if your blood glucose level becomes very high.
Danish: Dette kan være alvorlig, hvis dit blodsukkerniveau bliver meget højt.
English: These instructions may differ from general pump manual instructions.
Danish: Disse instruktioner kan afvige fra de generelle instruktioner i pumpemanualen.
English: If your blood sugar level is too high, this tells you that you may need more insulin than you have injected.
Danish: Hvis dit blodsukker er for højt, fortæller det dig, at du kan have brug for mere insulin end du har injiceret.
English: • Do not push the injection button while turning, as insulin will come out.
Danish: • Tryk ikke på dosisknappen, mens du drejer, da der så vil komme insulin ud.
English: Empty pens must never be reused and must be properly discarded.
Danish: Tomme penne må aldrig genbruges og skal bortskaffes på en betryggende måde.
English: Special caution must be taken when removing and disposing the needle.
Danish: Der skal udvises særlig forsigtighed ved fjernelse og bortskaffelse af nålen.
English: Subcutaneous use Abbreviation authorised for multilingual pack
Danish: Forkortelse er godkendt på flersprogede pakninger
English: The effect will be slightly quicker if the insulin is injected into your abdomen.
Danish: Effekten vil indtræde en smule hurtigere, hvis insulinen injiceres i dit maveskind.
English: Continuous subcutaneous insulin infusion
Danish: Kontinuerlig subkutan insulin-infusion
English: Mild hypoglycaemic episodes can be treated by oral administration of glucose or sugary products.
Danish: Milde tilfælde af hypoglykæmi kan behandles med oral administration af glucose eller sukkerholdige produkter.
English: • removing air bubbles
Danish: • fjerne luftbobler.
English: Apidra contains metacresol
Danish: Apidra indeholder metacresol
English: A. Select a dose of 2 units by turning the dosage selector.
Danish: A. Vælg en dosis på 2 enheder ved at dreje dosisskalaen.
English: The label on the pen should be checked to make sure it contains the correct insulin.
Danish: Etiketten på pennen skal kontrolleres for at sikre, at den indeholder den korrekte insulin.
English: It may also be given intravenously by healthcare professionals under close supervision by a doctor.
Danish: Det kan også gives intravenøst (i en vene) af uddannet sundhedspersonale under nøje overvågning af en læge.
English: Immediately after delivery, insulin requirements decline rapidly.
Danish: Umiddelbart efter fødslen falder insulinbehovet hurtigt.
English: However, hypoglycaemia may develop over sequential stages.
Danish: Hypoglykæmi kan dog udvikles over sekventielle faser:
English: Failure to follow these specific instructions may lead to serious adverse events.
Danish: Hvis du ikke overholder disse specifikke instruktioner, kan det føre til alvorlige bivirkninger.
English: It is advisable to test your blood sugar immediately after taking glucose to check that you really have hypoglycaemia.
Danish: Det anbefales, at blodsukkeret kontrolleres umiddelbart efter indtagelse af glucose for at se, om du virkelig havde hypoglykæmi.
English: Symptoms of hypoglycaemia usually occur suddenly.
Danish: Symptomer på hypoglykæmi opstår som regel pludseligt.
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: Kravene for fremsendelse af periodiske, opdaterede sikkerhedsindberetninger for dette lægemiddel fremgår af listen over EU-referencedatoer (EURD list), som fastsat i artikel 107c, stk. 7, i direktiv 2001/83/EF og alle efterfølgende opdateringer offentliggjort på den europæiske webportal for lægemidler.
English: A marked change (improvement or worsening) in your blood sugar control can disturb your vision temporarily.
Danish: En markant ændring (forbedring eller forværring) af dit blodsukker kan forårsage midlertidige synsforstyrrelser.
English: If you switch from another insulin to insulin glulisine, your dosage may have to be adjusted by your doctor.
Danish: Hvis du skifter fra et andet insulinpræparat til insulin glulisin, kan det være nødvendigt, at din læge justerer dosis.
English: If you have symptoms of low blood sugar, take actions to increase your blood sugar level immediately.
Danish: Hvis du får symptomer på for lavt blodsukker, skal du straks gøre noget for at øge dit blodsukker.
English: It is unknown whether insulin glulisine is excreted in human milk, but in general insulin does not pass into breast milk and is not absorbed after oral administration.
Danish: Det vides ikke, om insulin glulisin udskilles i human mælk, men som hovedregel passerer insulin ikke over i modermælken og absorberes ikke efter oral administration.
English: Needles must not be reused.
Danish: Nåle må ikke genbruges.
English: Patients should be advised to take precautions to avoid hypoglycaemia whilst driving.
Danish: Patienterne skal rådes til at tage forholdsregler for at undgå hypoglykæmi i forbindelse med bilkørsel.
English: The time of occurrence of hypoglycaemia depends on the action profile of the insulins used and may, therefore, change when the treatment regimen is changed.
Danish: Tidspunktet, for hvornår hypoglykæmi opstår, afhænger af virkningsprofilen for de anvendte insuliner og kan derfor ændre sig, hvis behandlingen ændres.
English: If you have any questions about SoloStar or about diabetes, ask your doctor, pharmacist or nurse or call the local sanofi-aventis number on the front of this leaflet.
Danish: Hvis du har nogen spørgsmål vedrørende SoloStar eller diabetes, så spørg sundhedspersonalet eller ring til det lokale sanofi-aventis nummer i denne indlægsseddel.
English: There are no or limited amount of data (less than 300 pregnancy outcomes) from the use of insulin glulisine in pregnant women.
Danish: Der er ingen eller utilstrækkelige data (færre end 300 gravide forsøgspersoner) fra anvendelse af insulin glulisin til gravide kvinder.
English: Measure your blood sugar level regularly to make sure you get the benefit of the insulin infusion and to make sure that the pump is working properly.
Danish: Mål dit blodsukker regelmæssigt for at sikre, at du får gavn af insulin-infusionen, og for at være sikker på, at pumpen fungerer korrekt.
English: Then the injection button should be held down 10 seconds before withdrawing the needle.
Danish: Derefter holdes dosisknappen inde i 10 sekunder, før nålen trækkes ud.
English: After intravenous administration, a faster onset and shorter duration of action, as well as a greater peak response were observed as compared with subcutaneous administration.
Danish: Efter intravenøs administration blev der observeret en hurtigere indsættende virkning og en kortere virkningsvarighed såvel som en større peak respons sammenlignet med subkutan administration.
English: If your blood sugar level starts to rise, contact your doctor, pharmacist or nurse as soon as possible.
Danish: Hvis dit blodsukker begynder at stige, skal du kontakte lægen, apotekspersonalet eller sundhedspersonalet så hurtigt som muligt.
English: Insulin requirements may be altered during illness or emotional disturbances.
Danish: Insulinbehovet kan ændres under sygdom eller ved følelsesmæssig ubalance.
English: Animal reproduction studies have not revealed any differences between insulin glulisine and human insulin regarding pregnancy, embryonal/foetal development, parturition or postnatal development (see section 5.3).
Danish: Reproduktionsstudier på dyr har ikke vist nogen forskelle mellem insulin glulisin og human insulin hvad angår graviditet, embryonal/føtaludvikling, fødsel eller postnatal udvikling (se pkt.
English: Systemic hypersensitivity reactions
Danish: Systemiske overfølsomhedsreaktioner
English: If you are not confident about recognising your warning symptoms, avoid situations (such as driving a car) in which you or others would be put at risk by hypoglycaemia.
Danish: Hvis du har svært ved at genkende advarselssymptomerne, bør du undgå situationer (som f.eks. bilkørsel), hvor du selv eller andre kan bringes i fare på grund af risikoen for hypoglykæmi.
English: Organ system classes
Danish: Systemorganklasse