FrancophonIA/ELRC3.0 huggingface dataset:
English: Taking such medicines at the same time as [Product name] can increase the risk of damage to the kidneys - medicines which can affect your nervous system.
Danish: Hvis sådanne lægemidler tages samtidig med [Produktnavn], kan det øge risikoen for skade på nyrerne - lægemidler, der kan påvirke nervesystemet.
English: Note: The existing package leaflet shall be amended (insertion, replacement or deletion of the text as appropriate) to reflect the wording below.
Danish: Bemærk: Den eksisterende indlægsseddel skal ændres (indsættelse, udskiftning eller sletning af tekst efter behov), så den afspejler teksten nedenfor.
English: Note: The existing package leaflet shall be amended (insertion, replacement or deletion of the text as appropriate) to reflect the wording below:
Danish: Bemærk: Den eksisterende indlægsseddel skal ændres (indsættelse, udskiftning eller sletning af tekst efter behov), så den afspejler teksten nedenfor:
English: Colistimethate sodium undergoes hydrolysis to the active substance colistin in aqueous solution.
Danish: Colistimethatnatrium gennemgår hydrolyse til det aktive stof colistin i vandig opløsning.
English: Taking such medicines at the same time as [Product name] can increase the risk of damage to the kidneys.
Danish: Hvis sådanne lægemidler tages samtidig med [Produktnavn], kan det øge risikoen for nyreskader
English: 5.5-7.5 MIU
Danish: Døgndosis 5,5-7,5 MIE 4,5-5,5 MIE 3,5 MIE
English: Taking such medicines at the same time as [Product name] can increase the risk of side effects in your nervous system - medicines called muscle relaxants, often used during general anaesthesia.
Danish: Hvis sådanne lægemidler tages samtidig med [Produktnavn], kan det øge risikoen for bivirkninger i nervesystemet - lægemidler, der kaldes muskelafslappende lægemidler og ofte bruges under fuld bedøvelse.
English: Note: The wording of this section should be revised for all SmPCs for products for intravenous administration of CMS/colistin to include the following warnings:
Danish: Bemærk: Teksten i dette afsnit skal revideres i alle produktresuméer for produkter til intravenøs administration af CMS/colistin, så de inkluderer følgende advarsler:
English: The mechanism of conversion of colistimethate sodium to the active substance, colistin, is not characterised.
Danish: Mekanismen ved omdannelse af colistimethatnatrium til det aktive stof colistin er ikke klarlagt.
English: Based on limited data, the following dose is recommended in adults:
Danish: Følgende dosis, der er baseret på begrænsede data, anbefales til voksne: Intraventrikulær administration
English: Hepatic impairment Dose adjustment is not considered necessary
Danish: Det vurderes, at dosisjustering ikke er nødvendig
English: [Product name] is indicated for the management in adult and paediatric of chronic pulmonary infections due to Pseudomonas aeruginosa in patients with cystic fibrosis (see section 5.1).
Danish: Afsnit 4.1 Terapeutiske indikationer [Produktnavn] er indiceret til behandling af kroniske lungeinfektioner forårsaget af Pseudomonas aeruginosa hos børn og voksne med cystisk fibrose (se pkt.
English: Note: The wording of this section should be revised for all SmPCs for products for intravenous administration of CMS/colistin to include the following statements:
Danish: Bemærk: Teksten i dette afsnit skal revideres i alle produktresuméer for produkter til intravenøs administration af CMS/colistin, så den inkluderer følgende oplysninger:
English: The use of intrathecal or intraventricular administration of colistimethate sodium in the treatment of meningitis was not systematically investigated in clinical trials and is supported by case reports only.
Danish: Intravenøs colistimethatnatrium krydser ikke blod-hjerne-barrieren i klinisk relevant grad. Intratekal eller intraventrikulær administration af colistimethatnatrium til behandling af meningitis er ikke blevet systematisk undersøgt i kliniske forsøg og understøttes udelukkende kasuistisk.
English: Confusion and medication errors have occurred because of the different expressions of dose in terms of potency.
Danish: De forskellige termer til at udtrykke dosis i forhold til potens har givet anledning til forvirring og medicineringsfejl.
English: It is estimated that approximately 30% of colistimethate sodium is converted to colistin in healthy subjects, its clearance is dependent on creatinine clearance and as renal function decreases, a greater portion of CMS is converted to colistin.
Danish: Dets clearance er afhængig af kreatininclearance, og ved faldende nyrefunktion omdannes en større del af CMS til colistin.
English: CMS conversion table
Danish: CMS-omregningstabel Styrke
English: IU
Danish: IE
English: Three times daily dosing is recommended.
Danish: Det anbefales, at døgndosis fordeles på 3 doser.
English: - If you suffer from myasthenia gravis - If you suffer from porphyria - If you suffer from asthma.
Danish: - hvis De lider af myasthenia gravis (en sjælden sygdom, hvor musklerne er meget svage og hurtigt bliver trætte) - hvis De lider af porfyri (en sjælden stofskiftesygdom).
English: [Product name] is indicated in adults and children including neonates for the treatment of serious infections due to selected aerobic Gram-negative pathogens in patients with limited treatment options (see sections 4.2, 4.4, 4.8 and 5.1).
Danish: Bemærk: Teksten i dette afsnit skal erstattes med følgende tekst: [Produktnavn] er indiceret behandling af alvorlige infektioner, forårsaget af udvalgte aerobe, gramnegative patogener, hos voksne og børn, herunder nyfødte, med begrænsede behandlingsmuligheder (se pkt.
English: Children < 2 years 0.5-1 MIU twice daily (max 2 MIU/ day)
Danish: 0,5-1 MIE to gange dagligt (maks.
English: Twice daily dosing is recommended.
Danish: Det anbefales, at døgndosis fordeles på 2 doser.
English: [Information on suitable nebuliser(s) and output characteristics may be included]
Danish: [Information om egnede nebulisatorer og afgivelsesegenskaber kan eventuelt inkluderes] Colistimethatnatrium gennemgår hydrolyse til det aktive stof colistin i vandig opløsning.
English: Dose adjustment is not considered necessary, however caution is advised in patients with renal impairment (see sections 4.4 and 5.2).
Danish: Det tilrådes dog at udvise forsigtighed hos patienter med nedsat nyrefunktion (se pkt.
English: 4.5-5.5 MIU
Danish: 4.4 og 5.2).
English: 3.5 MIU
Danish: 125.000 IE/døgn
English: Haemodialysis
Danish: Produktresumé
English: EUCAST Breakpoints
Danish: EUCAST-grænseværdier
English: Distribution
Danish: Administration
English: • Balance of water and salts in your body.
Danish: • Balancen mellem vand og salte i din krop.
English: Your doctor will monitor your heart and your unborn baby.
Danish: Lægen vil overvåge dit hjerte og dit ufødte barn.
English: - threatened abortion during the 1st and 2nd trimester
Danish: - truende abort i 1. og 2. trimester
English: These parameters should be carefully monitored during treatment.
Danish: Disse parametre skal monitoreres omhyggeligt under behandlingen.
English: The following measures will be taken where necessary:
Danish: Følgende målinger vil blive taget, hvis det er nødvendigt:
English: You will receive <invented name> for a maximum of 48 hours.
Danish: Du vil få <invented name> i højst 48 timer.
English: The product information may be subsequently updated by the Member State competent authorities, in liaison with the Reference Member State, as appropriate, in accordance with the procedures laid down in Chapter 4 of Title III of Directive 2001/83/EC.
Danish: Produktinformationen kan efterfølgende opdateres af de relevante myndigheder i medlemsstaten i samarbejde med referencemedlemsstaten efter behov i henhold til de procedurer, der er fastsat i afsnit III, kapitel 4 i direktiv 2001/83/EC.
English: - Any condition at a gestational age < 22 weeks
Danish: - enhver tilstand ved gestationsalder < 22 uger
English: <invented name> is contra-indicated in the following conditions:
Danish: <invented name> er kontraindiceret ved følgende tilstande:
English: B. Parenteral medicinal products for obstetric indications
Danish: B. Parenterale lægemidler til obstetriske indikationer
English: A. Oral formulation medicinal products and suppositories
Danish: A. Lægemidler med oral formulering og suppositorier
English: <invented name> can have an effect on the way some medicines work, and some medicines can effect how <invented name> works.
Danish: <invented name> kan påvirke den måde, hvorpå nogle lægemidler virker, og nogle lægemidler kan påvirke, hvordan <invented name> virker.
English: Your doctor may also take blood tests to monitor for changes in your blood (see section 3).
Danish: Lægen kan også tage blodprøver for at undersøge, om der er sket ændringer i dit blod (se punkt 3).
English: This will give your doctor or midwife time to take extra measures that will improve the health of your baby.
Danish: Dette vil give lægen eller jordemoderen tid til at tage ekstra forholdsregler, der vil forbedre dit barns sundhed.
English: This short term delay may be used to implement other measures known to improve perinatal health.
Danish: Denne kortvarige forsinkelse kan anvendes til at tage andre forholdsregler, der vides at forbedre den perinatale sundhed.
English: If this happens to you, tell your doctor or nurse straight away.
Danish: Hvis dette sker for dig, skal du straks sige det til lægen eller sundhedspersonalet.
English: Chest pain (due to heart problems such as angina).
Danish: Brystsmerter (på grund af hjerteproblemer såsom angina).
English: The volume of fluid in which the drug is administered should thus be kept to a minimum.
Danish: Væskevolumenet, som lægemidlet administreres i, skal således holdes på et minimum.
English: Treatment should be discontinued, whenever possible, at least 6 hours before any scheduled anaesthesia with halogenated anaesthetics.
Danish: Behandlingen bør afbrydes, om muligt, mindst 6 timer inden enhver planlagt anæstesi med halogenerede anæstetika.
English: Important side effects to look out for when treated for premature labour:
Danish: Vigtige bivirkninger, der skal holdes øje med ved behandling i forbindelse med for tidlig fødsel:
English: This Summary of Product Characteristics, labelling and package leaflet is the outcome of the referral procedure.
Danish: Dette produktresumé, denne etikettering og indlægsseddel er resultatet af referenceproceduren.
English: A controlled infusion device should be used, preferably a syringe pump.
Danish: Der skal anvendes en kontrolleret infusionsanordning, fortrinsvis en sprøjtepumpe.
English: Your doctor will consider the lowering of your dose or discontinuing <invented name> if your heart rate exceeds 120 beats per minute.
Danish: Lægen vil overveje at sænke din dosis eller afbryde behandlingen med <invented name>, hvis din puls overstiger 120 slag i minuttet.
English: [All oral formulations and suppositories (see Annex I) should delete the obstetric indications from their product information.
Danish: [I alle orale formuleringer og suppositorier (se Bilag I) skal de obstetriske indikationer slettes fra produktinformationen.
English: • <invented name> is <also> used in women who have unexpectedly gone into early labour (premature labour) between the 22nd and 37th week of gestation, to provide a short delay in the early delivery of the baby.
Danish: • <invented name> anvendes <også> til kvinder, der uventet er gået i tidlig fødsel (præmatur fødsel) mellem 22. og 37. uge i graviditeten, med henblik på at få en kort udsættelse af den tidlige fødsel af barnet.
English: Falls in diastolic pressure are usually within the range of 10 to 20mmHg.
Danish: Faldet i diastolisk blodtryk ligger almindeligvis i intervallet 10 til 20 mmHg.
English: The following side effects have also been observed with all beta-agonists like <invented name> when used to delay premature labour.
Danish: Følgende bivirkninger er også observeret ved alle betaagonister som <invented name>, når de bruges til at udsætte for tidlig fødsel.
English: [Details on dose and infusion rate will need to be adapted to specifics for individual drug substances i.e. retained as is per product any reference to continuing treatment with oral maintenance therapy should be removed.]
Danish: [Detaljer om dosis og infusionshastighed skal tilpasses de enkelte lægemidler, dvs. beholdes som de er for hvert produkt, og alle henvisninger til fortsat behandling med oral vedligeholdelsesbehandling skal fjernes.]
English: [The wording below should be inserted in the relevant sections]
Danish: [Nedenstående formulering skal indsættes i de relevante afsnit]
English: Administration of beta agonists is associated with a rise of blood glucose.
Danish: Administration af betaagonister er forbundet med en stigning i blodglucose.
English: The effect of infusion on foetal heart rate is less marked, but increases of up to 20 beats per minute may occur.
Danish: Infusionens virkning på fostrets hjertefrekvens er mindre markant, men der kan forekomme stigninger på op til 20 slag i minuttet.
English: Treatment with <invented name> should only be initiated by obstetricians/physicians experienced in the use of tocolytic agents.
Danish: Behandling med <invented name> bør kun indledes af obstetrikere/læger, der har erfaring med anvendelse af tokolytiske lægemidler.
English: Any decision to initiate therapy with <invented name> should be undertaken after careful consideration of the risks and benefits of treatment.
Danish: Enhver beslutning om at indlede behandling med <invented name> skal tages efter nøje overvejelse af risici og fordele ved behandlingen.
English: - as a tocolytic agent in patients with pre-existing ischaemic heart disease or those patients with significant risk factors for ischaemic heart disease.
Danish: - som et tokolytisk lægemiddel hos patienter med allerede eksisterende iskæmisk hjertesygdom eller patienter med betydelige risikofaktorer for iskæmisk hjertesygdom
English: * These reactions have been reported in association with the use of short acting beta-agonists in obstetric indications and are considered class effects (see section 4.4)
Danish: * Disse bivirkninger er indberettet i forbindelse med brug af korttidsvirkende betaagonister ved obstetriske indikationer og anses for at være klasseeffekter (se pkt.
English: It will always be given to you by a person who is qualified to do so after careful consideration of the balance of benefits of <invented name> to your baby and the potential untoward effects the treatment may have on you.
Danish: Du vil altid få medicinen af en person, der er kvalificeret til det, efter nøje afvejning af fordelene ved <invented name> for dit barn og de mulige bivirkninger, behandlingen kan have for dig.
English: [The existing product information shall be amended (insertion, replacement or deletion of the text as appropriate) to reflect the agreed wording as provided below]
Danish: [Den eksisterende produktinformation skal ændres (der skal indsættes, erstattes eller slettes tekst, hvor det er relevant), så det reflekterer ordlyden angivet nedenfor]
English: Increases in maternal heart rate of the order of 20 to 50 beats per minute usually accompany infusion of beta-agonists.
Danish: Stigning i moderens hjertefrekvens i størrelsesordenen fra 20 til 50 slag i minuttet er almindeligvis en følge af infusion af betaagonister.
English: Tocolysis with beta-agonists is not recommended when membranes have ruptured or the cervix dilation is beyond 4cm.
Danish: Tokolyse med betaagonister anbefales ikke, når vandet er gået, eller livmoderhalsen er udvidet mere end 4 cm.
English: In the short term management of uncomplicated premature labour.
Danish: Til kortvarig behandling ved ukompliceret præmatur fødsel
English: Generally maternal pulse rate should not be allowed to exceed a steady rate of 120 beats per minute.
Danish: Generelt bør moderens puls ikke få lov til at overstige en stabil frekvens på 120 slag i minuttet.
English: • Blood sugar level and the occurrence of low body pH with a build-up of lactate in your blood (also known as lactic acidosis)
Danish: • Blodsukkerniveauet og for forekomst af lav pH-værdi i kroppen med stigning i laktat i blodet (kaldes også laktacidose).
English: Special cautions for infusion: The dose must be individually titrated with reference to suppression of contractions, increase in pulse rate and changes in blood pressure, which are limiting factors.
Danish: Særlige forsigtighedsregler ved infusion: Dosis skal titreres individuelt i henhold til undertrykkelse af veer, stigning i pulsen og ændringer i blodtrykket, som er begrænsende faktorer.
English: In order to minimise the risk of hypotension associated with tocolytic therapy, special care should be taken to avoid caval compression by keeping the patient in the left or right lateral positions throughout the infusion.
Danish: For at minimere risikoen for hypotension i forbindelse med tokolytisk behandling bør der udvises særlig forsigtighed for at undgå kompression af vena cava ved at lade patienten ligge på venstre eller højre side under hele infusionen.
English: Patients with predisposing factors including multiple pregnancies, fluid overload, maternal infection and pre-eclampsia may have an increased risk of developing pulmonary oedema.
Danish: Patienter med prædisponerende faktorer, herunder flerfoldsgraviditet, væskeophobning, infektion hos moderen og præeklampsi, kan have en øget risiko for at udvikle lungeødem.
English: The most common undesirable effects of <invented name> are correlated with the betamimetic pharmacological activity and may be limited or avoided by a close monitoring of hemodynamic parameters, such as blood pressure and heart rate, and an appropriate adjustment of the dose.
Danish: De hyppigste bivirkninger ved <invented name> hænger sammen med den betamimetiske farmakologiske aktivitet og kan begrænses eller undgås ved tæt monitorering af hæmodynamiske parametre, såsom blodtryk og puls, og en passende justering af dosis.
English: Rare (affects less than 1 in 1,000 people) Unusual or irregular heartbeats High levels of sugar (glucose) and/or lactic acid in your blood Flushing (reddening) of the face
Danish: Sjælden (forekommer hos færre end 1 ud af 1.000 patienter) Usædvanlig eller uregelmæssig puls Høje niveauer af sukker (glucose) og/eller mælkesyre i blodet Ansigtsrødme
English: Systemic corticosteroids are frequently given during premature labour to enhance foetal lung development.
Danish: Systemiske kortikosteroider administreres ofte under præmatur fødsel for at øge den føtale lungeudvikling.
English: There have been reports of pulmonary oedema in women concomitantly administered with beta-agonists and corticosteroids.
Danish: Der har været indberetninger om lungeødem hos kvinder, der samtidigt får administreret betaagonister og kortikosteroider.
English: If there are changes in ECG recording and you have chest pain your doctor will stop the administration of <invented name>.
Danish: Hvis der er ændringer i dit EKG, og du har brystsmerter, vil lægen afbryde behandlingen med <invented name>.
English: • Blood potassium levels (low potassium levels may be associated with a risk of irregular heart beat)
Danish: • Kaliumniveauet i blodet (lave kaliumniveauer kan være forbundet med en risiko for uregelmæssig puls).
English: <invented name> should be administered as early as possible after the diagnosis of premature labour, and after evaluation of the patient to eliminate any contra-indications to the use of <INN SABA> (see section 4.3).
Danish: <invented name> bør administreres så tidligt som muligt efter diagnosen præmatur fødsel er stillet og patienten evalueret for eventuelle kontraindikationer for brug af <INN SABA> (se pkt.
English: This should include an adequate assessment of the patient's cardiovascular status with supervision of cardiorespiratory function and ECG monitoring throughout treatment (see section 4.4).
Danish: Dette bør inkludere en fyldestgørende vurdering af patientens kardiovaskulære status med overvågning af hjerte-lunge-funktionen og EKG-overvågning under hele behandlingen (se pkt.
English: The maternal pulse rate should be monitored and the need to control such increases by dose reduction or drug withdrawal should be evaluated on a case by case basis.
Danish: Moderens puls bør overvåges, og behovet for at håndtere sådanne stigninger ved reduktion af dosis eller seponering af lægemidlet bør vurderes fra patient til patient.
English: Tell your doctor immediately if you experience coughing or shortness of breath during treatment.
Danish: Fortæl det straks til lægen, hvis du oplever hoste eller kortåndethed under behandlingen.
English: Anti-diabetics
Danish: Antidiabetika
English: Treatment should be discontinued if signs of myocardial ischaemia (such as chest pain or ECG changes) develop.
Danish: Behandlingen skal afbrydes, hvis der opstår tegn på myokardieiskæmi (såsom brystsmerter eller forandringer i EKG).
English: • Blood pressure and heart rate.
Danish: • Blodtryk og hjerterytme (puls).
English: *Tachycardia.
Danish: *Takykardi
English: Low blood pressure which may cause light-headedness or dizziness Low levels of potassium in your blood which may cause muscle weakness, thirst, or “pins and needles”
Danish: Lavt blodtryk, der kan forårsage ørhed eller svimmelhed Lave kaliumniveauer i blodet, der kan forårsage muskelsvaghed, tørst eller prikkende og stikkende fornemmelse i huden
English: Common: *Palpitations, *decrease in diastolic pressure Rare:
Danish: Almindelig: *Palpitationer, *nedsat diastolisk blodtryk Sjælden:
English: 4.5 Interaction with other medicinal products and other forms of interaction [The wording below should be inserted in this section]
Danish: 4.5 Interaktion med andre lægemidler og andre former for interaktion [Nedenstående formulering skal indsættes i dette punkt]
English: <invented name> is also contraindicated in any pre-existing medical conditions with which a betamimetic would have an untoward effect e.g., pulmonary hypertension and cardiac disorders such as hypertrophic obstructive cardiomyopathy or any type of obstruction of the left ventricular outflow tract, e.g. aortic stenosis.
Danish: <invented name> er også kontraindiceret ved enhver allerede eksisterende klinisk tilstand, hvor et betamimetisk lægemiddel ville have en utilsigtet virkning, f.eks. pulmonal hypertension og hjertelidelser såsom hypertrofisk obstruktiv kardiomyopati eller enhver type obstruktion i venstre ventrikels udløb, f.eks. aortastenose.
English: Careful control of the level of hydration is essential to avoid the risk of maternal pulmonary oedema
Danish: Omhyggelig kontrol af hydreringsniveauet er vigtig for at undgå risiko for lungeødem hos moderen (se pkt.
English: If you are scheduled for surgery with general anaesthetics your doctor will stop the administration of <invented name> 6 hours before surgery whenever possible to protect you from adverse effects (e.g. irregular heart beat or bleeding of your womb).
Danish: Hvis du skal opereres under fuld bedøvelse, vil lægen så vidt muligt stoppe behandlingen med <invented name> 6 timer inden operationen for at beskytte dig mod bivirkninger (f.eks. uregelmæssig puls eller blødning fra livmoderen).
English: Treatment should only be carried out in facilities adequately equipped to perform continuous monitoring of maternal and foetal health status.
Danish: Behandling bør udelukkende udføres under forhold, hvor der er tilstrækkeligt udstyr til at udføre kontinuerlig overvågning af helbredstilstanden hos moderen og fostret.
English: <invented name> should be used with caution in tocolysis and supervision of cardiorespiratory function and ECG monitoring, should be performed throughout treatment.
Danish: <invented name> bør anvendes med forsigtighed til tokolyse, og overvågning af hjerte-lungefunktionen samt EKG-overvågning skal udføres under hele behandlingen.
English: Therefore blood glucose and lactate levels should be monitored in mothers with diabetes and diabetic treatment adjusted accordingly to meet the needs of the diabetic mother during tocolysis (see section 4.5).
Danish: Derfor bør blodglucoseog -laktatniveauet monitoreres hos mødre med diabetes, og den antidiabetiske behandling justeres i overensstemmelse hermed for at imødegå behovet hos diabetiske mødre under tokolyse (se pkt.