FrancophonIA/ELRC3.0 huggingface dataset:
English: • Following an EU-wide review of codeine when used for cough and cold, changes have been made to the way the medicine is used to ensure that the benefits continue to outweigh the risks in children and adolescents.
Danish: • Efter at anvendelsen af kodein ved hoste og forkølelse er blevet gennemgået i hele EU, er der foretaget ændringer i lægemidlets anvendelse for at sikre, at fordelene stadig overstiger risiciene ved anvendelse hos børn og unge.
English: High levels of morphine can lead to serious effects, such as breathing difficulties.
Danish: Høje koncentrationer af morfin medfører alvorlige bivirkninger såsom vejrtrækningsbesvær.
English: The effects of codeine are due to its conversion into morphine in the body.
Danish: Kodeins virkninger skyldes dets omdannelse til morfin i kroppen.
English: The restrictions for codeine for cough and cold are largely in line with the previous recommendations for codeine when used for pain relief.
Danish: Begrænsningerne for kodein ved hoste og forkølelse er i det store hele på linje med tidligere anbefalinger for kodein ved anvendelse som smertestillende middel.
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom24 April 2015 EMA/249413/2015
Danish: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom
English: This review comes after a previous review of codeine for pain relief in children, which resulted in several restrictions being introduced in order to ensure that the medicine was used as safely as possible.
Danish: Gennemgangen følger efter en tidligere gennemgang af kodein til smertelindring hos børn, hvor der blev indført begrænsninger, der skulle gøre anvendelsen af lægemidlet så sikker som muligt.
English: The CMDh1 has agreed by consensus new measures to minimise the risk of serious side effects, including breathing problems, with codeine-containing medicines when used for cough and cold in children.
Danish: CMDh1 har enstemmigt vedtaget nye foranstaltninger, der skal minimere risikoen for alvorlige bivirkninger, herunder vejrtrækningsbesvær, ved brug af kodeinholdige lægemidler mod hoste og forkølelse hos børn.
English: The review was carried out by the Pharmacovigilance Risk Assessment Committee (PRAC), EMA's Committee responsible for the evaluation of safety issues for human medicines, which has made a set of recommendations.
Danish: Gennemgangen blev foretaget af Udvalget for Risikovurdering inden for Lægemiddelvurdering (PRAC), som er EMA's udvalg med ansvar for vurdering af sikkerhedsspørgsmål vedrørende lægemidler til mennesker.
English: In addition, children who already have problems with their breathing may be more susceptible to respiratory problems due to codeine.
Danish: Børn, der i forvejen har vejrtrækningsproblemer, kan desuden være ekstra følsomme for vejrtrækningsproblemer forårsaget af kodein.
English: • Codeine is also contraindicated in women during breastfeeding and patients known to be CYP2D6
Danish: • Kodein er desuden kontraindiceret hos kvinder, der ammer, og hos patienter, der vides at være ultrahurtige CYP2D6-metabolisatorer.
English: In total, 14 cases of codeine intoxication in children (aged from 17 days to 6 years) related to the treatment of cough and respiratory infection were identified in the published literature, four of which had a fatal outcome.
Danish: I alt blev der i litteraturen fundet 14 tilfælde af kodeinintoksikation hos børn (alder fra 17 dage til 6 år) ved behandling af hoste og luftvejsinfektion, heraf fire fatale tilfælde.
English: It is widely used for pain relief and for the treatment of the symptoms of coughs and colds.
Danish: Det har stor udbredelse som smertestillende middel og til symptombehandling ved hoste og forkølelse.
English: The PRAC also noted that cough and cold are generally self-limiting conditions and the evidence that codeine is effective at treating cough in children is limited.
Danish: PRAC bemærkede derudover, at hoste og forkølelse sædvanligvis er selvbegrænsende tilstande, og at der kun er begrænset dokumentation for, at kodein er effektivt mod hoste hos børn.
English: In addition, the evidence that codeine is effective at treating cough in children is limited and international guidelines emphasise that cough associated with viral infections may be satisfactorily managed with fluids and increased ambient humidity; in the case of chronic cough, treatment should be directed at the underlying disease.
Danish: Der er desuden kun begrænset evidens for den hostestillende virkning af kodein hos børn, og internationale retningslinjer understreger, at hoste ved virusinfektioner kan behandles sufficient med væsketilførsel og forhøjet fugtindhold i den omgivende luft, mens behandlingen af kronisk hoste bør rettes mod den underliggende sygdom.
English: The available data indicate that the way codeine is converted into morphine in children below 12 years is more variable and unpredictable, making this population at special risk of morphine-induced side effects.
Danish: De foreliggende data viser, at hos børn under 12 år er omdannelsen af kodein til morfin mere variabel og uforudsigelig, hvorfor denne gruppe har særlig risiko for morfininducerede bivirkninger.
English: • Codeine-containing medicines for cough and cold must not be used in children below 12 years of age because of the risk of serious side effects, including breathing problems.
Danish: • Kodeinholdige lægemidler mod hoste og forkølelse må ikke anvendes hos børn under 12 år på grund af risikoen for alvorlige bivirkninger, herunder vejrtrækningsbesvær.
English: • Mothers who are breastfeeding must not take codeine as codeine can harm the baby because it passes into breast milk.
Danish: • Mødre, der ammer, må ikke få kodein, fordi kodein går over i modermælk og kan være skadeligt for barnet.
English: • Parents and caregivers who notice any of the following symptoms in a patient given codeine should stop giving the medicine and seek medical attention immediately: slow or shallow breathing,
Danish: • Hvis forældre eller omsorgsgivere bemærker nogen af følgende symptomer hos en patient, som får kodein, skal de stoppe med at give lægemidlet og straks søge lægehjælp: langsom eller overfladisk vejrtrækning, omtågethed, søvnighed, små pupiller, kvalme eller opkastning, forstoppelse og nedsat appetit.
English: The PRAC considered that, although morphine-induced side effects may occur in patients of all ages, the way codeine is converted into morphine in children below 12 years is more variable and unpredictable, making this population at special risk of such side effects.
Danish: PRAC tog i betragtning, at selv om morfin kan bevirke bivirkninger hos patienter i alle aldre, er omdannelsen af kodein til morfin hos børn under 12 år mere variabel og uforudsigelig.
English: • Codeine for cough and cold is now contraindicated in children below 12 years, and not recommended in children between 12 and 18 years with compromised respiratory function.
Danish: • Kodein mod hoste og forkølelse er nu kontraindiceret hos børn under 12 år og frarådes hos børn mellem 12 og 18 år med nedsat respirationsfunktion.
English: As codeine-containing medicines are all authorised nationally, the PRAC recommendations were forwarded to the CMDh for its position.
Danish: Derfor blev PRAC's anbefalinger overgivet til CMDh til udtalelse.
English: Some people convert codeine to morphine at a faster rate than normal, resulting in high levels of morphine in their blood.
Danish: Nogle personer omdanner kodein til morfin hurtigere end normalt.
English: In addition to the new measures for children, codeine must also not be used in people of any age who are known to convert codeine into morphine at a faster rate than normal (‘ultra-rapid metabolisers') nor in breastfeeding mothers, as codeine can harm the baby because it passes into breast milk.
Danish: Ud over de ændrede regler for børn må kodein desuden ikke anvendes hos personer uanset alder, der vides at omdanne kodein til morfin særlig hurtigt ("ultrahurtige metabolisatorer").
English: • Patients of all ages who are known to be ‘ultra-rapid metabolisers', which means that they convert codeine into morphine very rapidly, must not use codeine for cough and cold as they are more at risk of serious side effects with codeine.
Danish: • Kodein må ikke anvendes mod hoste og forkølelse hos patienter uanset alder, som vides at omdanne kodein ekstra hurtigt til morfin, dvs. "ultrahurtige metabolisatorer".
English: Codeine not to be used in children below 12 years for cough and cold
Danish: Slut med at anvende kodein mod hoste og forkølelse hos børn under 12 år
English: Codeine is an opioid medicine that is converted into morphine in the body.
Danish: Kodein er et lægemiddel af typen opioider.
English: • Use of codeine for cough and cold is now contraindicated in children below 12 years.
Danish: • Hos børn under 12 år er det nu kontraindiceret at bruge kodein mod hoste og forkølelse.
English: codeine is not recommended as this population may be more susceptible to breathing problems due to codeine.
Danish: Det er fordi denne gruppe er særlig udsat for alvorlige bivirkninger med kodein.
English: On 22 April 2015 the CMDh adopted its position by consensus, so the measures recommended by the PRAC will be directly implemented by the Member States where the medicines are authorised, according to an agreed timetable.
Danish: Den 22. april 2015 vedtog CMDh udtalelsen enstemmigt.
English: • In children and adolescents between 12 and 18 years who have problems with their breathing,
Danish: • Til børn og unge mellem 12 og 18 år med vejrtrækningsbesvær frarådes det at anvende kodein mod hoste og forkølelse.
English: • Use of codeine for cough and cold is not recommended in children and adolescents between 12 and 18 years who have breathing problems.
Danish: • Brug af kodein frarådes hos børn og unge mellem 12 og 18 år med vejrtrækningsproblemer, fordi denne gruppe kan være ekstra følsom for vejrtrækningsproblemer forårsaget af kodein.
English: Your doctor will check this.
Danish: Din læge vil kontrollere dette.
English: 3 Extravasation has been reported very rarely.
Danish: 3Ekstravasation er meget sjældent rapporteret.
English: Your doctor should dispose of medicines that are no longer required.
Danish: Din læge bør bortskaffe lægemidler, som ikke længere er nødvendige.
English: Other in-use storage times and conditions are the responsibility of the user.
Danish: Andre opbevaringstider og -forhold er brugerens ansvar.
English: The following information is intended for medical or healthcare professionals only:
Danish: Følgende information er kun tiltænkt læger og sundhedspersonale:
English: Study 065
Danish: Forsøg 065
English: • Reference to the vial collar as visual reminder of this difference and the instruction that it must not be removed at any time.
Danish: • Reference til hætteglassets krave som en visuel påmindelse om denne forskel, og den instruktion, at den ikke på noget tidspunkt må fjernes.
English: Topotecan Eagle can make you feel tired or weak.
Danish: Topotecan Eagle kan få dig til at føle dig træt eller svag.
English: This means that treatment is not recommended.
Danish: Det betyder, at behandling ikke
English: The following dosing tables should be used as reference:
Danish: Følgende doseringstabeller skal benyttes som reference:
English: It is a type of chemotherapy.
Danish: Det er en type kemoterapi.
English: - This treatment cycle will normally be repeated every 3 weeks.
Danish: - Denne behandlingscyklus gentages normalt hver 3. uge.
English: Study 396
Danish: Forsøg 396
English: - This medicine has been prescribed for you.
Danish: - Dette lægemiddel er blevet ordineret til dig personligt.
English: The experience of using Topotecan Eagle in children is limited.
Danish: Erfaringen med brug af Topotecan Eagle hos børn er begrænset.
English: The concentrate must be diluted before administration.
Danish: Koncentratet skal fortyndes inden administration.
English: SPECIAL STORAGE CONDITIONS Do not store above 25ºC.
Danish: SÆRLIGE OPBEVARINGSBETINGELSER Må ikke opbevares over 25ºC.
English: Tell your doctor immediately if you notice any of the following serious side effects.
Danish: Fortæl straks lægen, hvis du bemærker en eller flere af følgende alvorlige bivirkninger.
English: Topotecan is not recommended to be used in these patient groups.
Danish: Topotecan anbefales ikke til disse patientgrupper.
English: • When new information is received that may impact on the current Safety Specification, Pharmacovigilance Plan or risk minimisation activities
Danish: • når der modtages ny information, der kan have indflydelse på den gældende sikkerhedsspecifikation, lægemiddelovervågningsplan eller på risikominimeringsaktiviteter
English: Study results Study GOG-0179
Danish: Resultater forsøg GOG-0179
English: A reduction in topotecan clearance was observed.
Danish: En reduktion i clearance af topotecan blev observeret.
English: This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.
Danish: Dette lægemiddel må ikke blandes med andre lægemidler end dem, der er anført i pkt 6.6.
English: Dilution should be performed under strict aseptic conditions (e.g. an LAF bench).
Danish: Fortyndingen skal udføres under strengt aseptiske forhold (f.eks. en LAF bench).
English: • The risk of medication error due to the higher concentration than the dilution concentration of the originator, with potentially life-threatening consequences.
Danish: • Risikoen for medicineringsfejl på grund af den højere koncentration end fortyndingskoncentrationen af originalmidlet, med potentielt livstruende konsekvenser.
English: Opened on: DD/MM/YY
Danish: Åbnet den: DD/MM/ÅÅ
English: Each pack contains 1 vial.
Danish: Hver pakke indeholder 1 hætteglas.
English: - if you have unusual bruising or bleeding; - if you are feeling very ill.
Danish: - hvis du har usædvanlig blodudtrædning eller blødning; - hvis du føler dig meget syg.
English: Read all of this leaflet carefully before you start using this medicine.
Danish: Læs denne indlægsseddel grundigt inden du begynder at tage medicinen.
English: - Women who could get pregnant should use contraception to stop them getting pregnant during
Danish: Kvinder, som kan blive gravide, skal benytte prævention for at forhindre dem i at blive gravide
English: Accurate assessment of performance status at the time therapy is given is important, to ensure that patients have not deteriorated to performance status 3.
Danish: Det er vigtigt med en omhyggelig vurdering af performancestatus ved påbegyndelse af behandling for at sikre, at patienter ikke forværres til performancestatus 3.
English: No in vivo human pharmacokinetic interaction studies have been performed.
Danish: Der er ikke udført in vivo humane farmakokinetiske interaktionsforsøg.
English: Total dose (mg)
Danish: Samlet dosis (mg)
English: • A form to report medication errors.
Danish: • En formular til rapportering af medicineringsfejl.
English: If this happens, do not drive or use any tools or machines.
Danish: Hvis det sker, må du ikke køre bil eller bruge
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency (EMEA) http://www.emea.europa.eu/.
Danish: Yderligere information om dette lægemiddel er tilgængelig på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu/.
English: - unusual bruising or bleeding, sometimes severe.
Danish: - usædvanlige blå mærker eller blødninger, nogle gange alvorlige.
English: Pharmacotherapeutic group: Other antineoplastic agents, ATC code: L01XX17.
Danish: Farmakoterapeutisk klassifikation: Andre antineoplastiske stoffer: ATC-kode: L01XX17.
English: Volume of solution required (ml)
Danish: Volumen af påkrævet opløsning (ml)
English: Do not use Topotecan Eagle if any of the above apply to you.
Danish: Brug ikke Topotecan Eagle, hvis nogen af ovenstående tilfælde gælder for dig.
English: As expected, patients with poor performance status (PS>1) have a lower response rate and an increased incidence of complications such as fever, infection and sepsis (see section 4.8).
Danish: Som forventet har patienter med dårlig performancestatus (PS > 1) en lavere responsrate og en øget incidens af komplikationer såsom feber, infektion og sepsis (se pkt.
English: This medicine is not recommended if you have severe kidney problems; - if you have liver problems.
Danish: Dette lægemiddel anbefales ikke, hvis du har alvorlige nyreproblemer; - hvis du har leverproblemer.
English: Summary of survival, response rate and time to progression in SCLC patients treated with oral or intravenous topotecan
Danish: Oversigt over overlevelse, responsrate og tid til progression hos SCLC-patienter, der er behandlet med oral eller intravenøs topotecan
English: Frequencies are defined as: very common (≥ 1/10), common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000), including isolated reports and not known (cannot be estimated from the available data).
Danish: Hyppigheden defineres som: meget almindelig (≥ 1/10), almindelig (≥ 1/100 til < 1/10), ikke almindelig (≥ 1/1.000 til < 1/100), sjælden (≥ 1/10.000 til < 1/1.000), meget sjælden (< 1/10.000) og ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: The PSUR cycle for the medicinal product should follow a half-yearly cycle until otherwise agreed by the CHMP.
Danish: PSUR-cyklussen for lægemidlet skal følge den halvårlige cyklus, indtil andet godkendes af CHMP.
English: Mild abdominal pain was also reported amongst 4 % of patients.
Danish: Lette abdominalsmerter blev også rapporteret blandt 4 % patienterne.
English: In a population study, a number of factors including age, weight and ascites had no significant effect on clearance of total topotecan (active and inactive form).
Danish: I et populationsforsøg havde et antal faktorer, herunder alder, vægt og ascites ingen signifikant virkning på clearance af total-topotecan (aktiv og inaktiv form).
English: • Within 60 days of an important (pharmacovigilance or risk minimisation) milestone being
Danish: • senest 60 dage efter en vigtig milepæl er nået (lægemiddelovervågning eller risikominimering)
English: Among all patients treated in clinical trials (including both those with severe neutropenia and those who did not develop severe neutropenia), 11 % (4 % of courses) developed fever and 26 % (9 % of courses) developed infection.
Danish: Blandt alle patienter, der blev behandlet i de kliniske forsøg (herunder både dem med alvorlig neutropeni og dem, der ikke udviklede alvorlig neutropeni), udviklede 11 % (4 % af behandlingerne) feber, og 26 % (9 % af behandlingerne) udviklede infektion.
English: The user is requested to report any medication errors.
Danish: Brugeren skal rapportere eventuelle medicineringsfejl.
English: 18.3, 31.6) compared to 13.9 weeks (95 % C.I.
Danish: 18,3; 31,6) sammenlignet med 13,9 uger (95 % C.I.
English: How Topotecan Eagle is given Topotecan Eagle is normally given by a doctor or nurse: - as a drip (infusion) for about 30 minutes - usually into your arm.
Danish: Sådan bruges Topotecan Eagle Topotecan Eagle gives normalt af en læge eller en sygeplejerske: - som drop (infusion) i ca. 30 minutter - sædvanligvis i armen.
English: • The anticipated effects of overdose (e.g. bone marrow suppression).
Danish: • De forventede virkninger af overdosis (f.eks. knoglemarvssuppression).
English: Oral topotecan Intravenous topotecan Oral topotecan Intravenous topotecan
Danish: Oral topotecan Intravenøs topotecan
English: The median survival for patients treated with topotecan + BSC was 25.9 weeks (95 % C.I.
Danish: Medianoverlevelsen for patienter behandlet med topotecan + BSC var 25,9 uger (95 % C.I.
English: Metabolism and nutrition disorders Very common: anorexia (which may be severe)
Danish: Metabolisme og ernæring Meget almindelig: anoreksi (muligvis alvorlig)
English: The concentration of topotecan in Topotecan Eagle differs from other topotecan products and care should be taken to ensure appropriate dilution occurs to achieve the intended dose, which should be checked prior to administration to the patient.
Danish: Koncentrationen af topotecan i Topotecan Eagle adskiller sig fra andre topotecan-midler, og der bør udvises omhu for at sikre passende opløsning for at opnå den tilsigtede dosis, som skal kontrolleres før administration til patienten.
English: Like all medicines, Topotecan Eagle can cause side effects, although not everybody gets them.
Danish: Topotecan Eagle kan som al anden medicin give bivirkninger, men ikke alle får bivirkninger.
English: Overall recovery of medicinal product-related material following five daily doses of topotecan was 71 to 76 % of the administered intravenous dose.
Danish: Overordnet genfinding af lægemiddelstofrelateret materiale efter fem daglige doser af topotecan var 71 til 76 % af den administrerede intravenøse dosis.
English: Instructions on how to dilute, store and dispose of Topotecan Eagle
Danish: Instruktioner for fortynding, opbevaring og bortskaffelse af Topotecan Eagle
English: Do not use Topotecan Eagle if you notice any visible particles or if the solution is unclear.
Danish: Brug ikke Topotecan Eagle, hvis du ser partikler i væsken, eller hvis opløsningen er uklar.
English: Tumour types included were Ewing's Sarcoma/primitive neuroectodermal tumour, neuroblastoma, osteoblastoma, and rhabdomyosarcoma.
Danish: Følgende tumortyper var inkluderet: Ewing's sarkom/primitiv neuroektoderm tumor, neuroblastoma, osteoblastoma og rhabdomyosarcoma.
English: Approximately 51 % was excreted as total topotecan and 3 % was excreted as N-desmethyl topotecan in the urine.
Danish: Omtrent 51 % blev udskilt som uomdannet topotecan og 3 % blev udskilt som N-desmethyltopotecan i urinen.
English: In clinical trials, topotecan was discontinued if the dose had been reduced to 1.0 mg/m2 and a further dose reduction was required to manage adverse effects.
Danish: I kliniske forsøg blev topotecan-behandlingen stoppet, hvis dosis var blevet reduceret til 1,0 mg/m2 og yderligere reduktion af dosis var nødvendig for at håndtere bivirkninger.
English: The topotecan-O-glucuronide and N-desmethyl topotecan-O-glucuronide in the urine were less than 2.0 %.
Danish: Topotecan-Oglukuronid og N-desmethyltopotecan-O-glukuronid i urinen var mindre end 2,0 %.
English: In combining topotecan with other chemotherapy agents, reduction of the doses of each medicinal product may be required to improve tolerability.
Danish: Når topotecan gives sammen med andre kemoterapeutika kan det være nødvendigt at reducere dosis af de enkelte lægemidler for at forbedre tolerancen.
English: 11.1, 18.6) for patients receiving BSC alone (p = 0.0104).
Danish: 11,1; 18,6) for patienter, der fik BSC alene (p = 0,0104).
English: In clinical trials, rash was reported in 4 % of patients and pruritus in 1.5 % of patients.
Danish: I kliniske forsøg er hududslæt rapporteret hos 4 % af patienterne og pruritus hos 1,5 % af patienterne.
English: Frequently reported non-haematological effects were gastrointestinal such as nausea (52 %), vomiting (32 %), and diarrhoea (18 %), constipation (9 %) and mucositis (14 %).
Danish: Hyppigt rapporterede non-hæmatologiske bivirkninger var gastrointestinale, såsom kvalme (52 %), opkastning (32 %) og diarré (18 %), obstipation (9 %) og mucositis (14 %).
English: A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Danish: FREMSTILLERE ANSVARLIGE FOR BATCHFRIGIVELSE
English: Also some other medicines can affect the way Topotecan Eagle works.
Danish: Ligeledes kan visse andre lægemidler påvirke den måde, som Topotecan Eagle virker på.
English: Underlying risk factors include history of ILD, pulmonary fibrosis, lung cancer, thoracic exposure to radiation and use of pneumotoxic substances and/or colony stimulating factors.
Danish: Underliggende risikofaktorer inkluderer tidligere ILD, pulmonal fibrose, lungecancer, eksponering af thorax for stråler og brug af pneumotoksiske lægemidler og/eller kolonistimulerende faktorer.
English: Topotecan Eagle requires appropriate dilution before use.
Danish: Topotecan Eagle kræver passende fortynding før brug.
English: Body surface area (m
Danish: Legemsoverfladeareal (m