FrancophonIA/ELRC3.0 huggingface dataset:
English: ANNEX II AMENDMENTS TO THE SUMMARY OF PRODUCT CHARACTERISTICS AND PACKAGE LEAFLET
Danish: BILAG II ÆNDRINGER TIL PRODUKTRESUME OG INDLÆGSSEDDEL
English: Data in the age group < 1 year (4 patients) are very limited (see Section 5.1).
Danish: Data i aldersgruppen < 1 år er meget begrænsede (4 patienter) (se pkt.
English: All age groups were treated with latanoprost 0.005%, one drop daily in each eye for a minimum of 2 weeks.
Danish: Alle aldersgrupper blev behandlet med latanoprost 50 mikrogram/ml 1 dråbe dagligt i hvert øje i minimum 2 uger.
English: - An estimation of the mean exposure to latanoprost expected in the PASS studies will be submitted; - The timelines for the submission of the full study A6111144 protocol; - Revised table summary of the EU RMP to reflect the PASS studies as additional
Danish: - der skal fremsendes en vurdering af den forventede gennemsnitlige eksponering for latanoprost i PASS-undersøgelserne, - tidsfristerne for fremsendelse af den fuldstændige protokol for undersøgelse A6111144, - en revideret tabeloversigt over EU's risikostyringsplan, hvor PASS-undersøgelserne skal medtages som yderligere lægemiddelovervågningsaktiviteter og lægemiddelinteraktionerne som manglende information.
English: CT13 9NJ
Danish: CT13 9NJ United Kingdom
English: An open-label pharmacokinetic study of plasma latanoprost acid concentrations was undertaken in 22 adults and 25 paediatric patients (from birth to < 18 years of age) with ocular hypertension and glaucoma.
Danish: Plasmakoncentration af latanoprost-syre blev undersøgt i et open-label farmakokinetisk forsøg med 22 voksne og 25 pædiatriske patienter (fra nyfødt til < 18 år) med okulær hypertension og glaukom.
English: 23-25 Avenue du Docteur Lannelongue 75014 Paris France
Danish: Lannelongue 75014 Paris France
English: 4.1 Therapeutic indications
Danish: 4.1 Terapeutiske indikationer [Udfyldes nationalt]
English: The next updated version of the DDPS should be submitted together with the 6-monthly Periodic Safety Updated Report (PSUR) due after the European Commission decision.
Danish: Den næste opdaterede udgave skal fremsendes sammen med den halvårlige periodiske, opdaterede sikkerhedsindberetning (PSUR), der skal udarbejdes efter Europa-Kommissionens afgørelse.
English: No data are available for preterm infants (less than 36 weeks gestational age).
Danish: Der er ingen tilgængelige data for anvendelse til præmature børn (gestationsalder mindre end 36 uger).
English: Baseline Mean (SE)
Danish: Baseline, gennemsnit (SE)
English: Contact your doctor as soon as possible if you or your child swallows {Invented name} accidentally.
Danish: Kontakt lægen hurtigst muligt, hvis De eller Deres barn ved et uheld har drukket øjendråberne.
English: Within the next updated version of the Detailed Description of the Pharmacovigilance System (DDPS) the MAH will:
Danish: I den næste opdaterede udgave af den detaljerede beskrivelse af lægemiddelovervågningssystemet skal indehaveren af markedsføringstilladelsen:
English: If you or your child have severe asthma or the asthma is not well controlled If you or your child wear contact lenses.
Danish: • De eller Deres barn har svær astma eller astma, som ikke er velbehandlet
English: IOP reductions among subjects in the primary congenital/infantile glaucoma (PCG) subgroup were similar between the latanoprost group and the timolol group.
Danish: Reduktion i IOP hos patienter i undergruppen med primær kongenit/pædiatrisk glaukom (PCG) var ens i latanoprost- og timolol-gruppen.
English: POSSIBLE SIDE EFFECTS Side effects seen more often in children compared to adults are runny itchy nose and fever.
Danish: Bivirkningerne løbenæse, kløende næse og feber ses oftere hos børn end hos voksne.
English: If you stop using {Invented name} You should speak to your doctor or the doctor treating your child if you want to stop taking Xalatan.
Danish: Tal med Deres læge eller Deres barns læge, hvis De vil holde op med at bruge Xalatan.
English: If you have any further questions, ask your doctor or the doctor treating your child or your pharmacist.
Danish: Er De i tvivl, så spørg Deres læge eller Deres barns læge eller på apoteket.
English: This should pass, but if you are worried contact your doctor or the doctor treating your child for advice.
Danish: Hvis De er bekymret for dette, skal De kontakte Deres læge eller Deres barns læge for at få vejledning.
English: {Invented name} has not been investigated in prematurely born infants (less than 36 weeks gestation).
Danish: Xalatan er ikke undersøgt hos præmature børn (gestationsalder mindre end 36 uger).
English: The following text highlighted in bold should be reflected in the relevant sections of the package leaflet, as relevant.
Danish: Følgende tekst med fed skrift skal tilføjes relevant afsnit af indlægssedlen
English: Week 12 Change from Baseline Mean†(SE)
Danish: Gennemsnitlig ændring fra baseline ved uge 12† (SE) p-værdi vs. timolol
English: Paediatric population: {Invented name} eye drops may be used in paediatric patients at the same posology as in adults.
Danish: Xalatan øjendråber kan bruges til børn i samme dosering som til voksne.
English: This medicine has been prescribed for you or for your child. Do not pass it on to others.
Danish: Lægen har ordineret denne medicin til Dem eller Deres barn.
English: 4.2 Posology and method of administration
Danish: 4.2 Dosering og indgivelsesmåde [Udfyldes nationalt]
English: Baseline Mean (SE) Week 12 Change from Baseline Mean†(SE)
Danish: Baseline, gennemsnit (SE) Gennemsnitlig ændring fra baseline ved uge 12† (SE)
English: Please tell your doctor, the doctor treating your child or pharmacist if you or your child are taking or have taken any other medicines including those medicines (or eye drops) obtained without a prescription.
Danish: Tal med Deres læge eller den læge, der behandler Deres barn, eller apoteket, hvis en bivirkning bliver værre, eller De eller Deres barn får bivirkninger, som ikke er nævnt her.
English: 0,005% Eye drops, solution Ocular use
Danish: 0.005% Øjendråber, opløsning
English: Ramsgate Road Sandwich, Kent CT13 9NJ
Danish: Pfizer Europe MA EEIG, Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom
English: Contact lens wearers
Danish: Kontaktlinsebrugere
English: Pfizer bv
Danish: Pfizer bv Rivium Westlaan
English: You should check with your doctor, or the doctor treating your child or pharmacist if you are not sure.
Danish: Spørg Deres læge eller den læge, der behandler Deres barn, eller på apoteket, hvis der er mere, De vil vide.
English: de Europa 20B Parque Empresarial la Moraleja
Danish: de Europa 20B
English: HOW TO USE {INVENTED NAME}
Danish: VIRKNING OG ANVENDELSE [Udfyldes nationalt]
English: Adverse events seen more frequently in the paediatric population as compared to adults are: nasopharyngitis and pyrexia.
Danish: Nasopharyngitis og pyreksi forekom hyppigere hos børn end hos voksne.
English: 50 microg/ml Eye drops, solution Topical use
Danish: 50 mikrog/ml Øjendråber, opløsning
English: Important information about some of the ingredients of {Invented name} If you or your child wear contact lenses, they should be removed before using {Invented name}.
Danish: Hvis De eller Deres barn bruger kontaktlinser, skal disse tages ud, inden øjnene dryppes.
English: Talk to your doctor, or the doctor treating your child or your pharmacist before you take {Invented name} or before you give this to you child if you think any of the following apply to you or your child: If you or your child are about to have or have had eye surgery (including cataract surgery) If you or your child suffer from eye problems (such eye pain, irritation or inflammation, blurred vision) If you or your child suffers from dry eyes
Danish: • De eller Deres barn har problemer med øjnene (f.eks. øjensmerter, øjenirritation eller øjenbetændelse, uklart syn)
English: PHARMACOLOGICAL PROPERTIES
Danish: Lægemiddelfor m
English: 0.005% w/v Eye drops, solution Ocular use
Danish: 0.05 mg/ml Øjendråber, opløsning
English: Taking other medicines {Invented name} may interact with other medicines.
Danish: Xalatan kan påvirke virkningen af anden medicin og anden medicin kan påvirke virkningen af Xalatan.
English: Date of first authorisation: 2 December 2015
Danish: Dato for første markedsføringstilladelse: 2 December 2015
English: CIAMBRA may make you feel tired.
Danish: CIAMBRA kan muligvis gøre Dem træt.
English: From a microbiological point of view, the infusion solution should be used immediately.
Danish: Fra et mikrobielt synspunkt skal infusionsopløsningen anvendes med det samme.
English: * Definition of frequency terms: Very common - ≥ 10%; Common - > 5% and < 10%.
Danish: * Definition af hyppighed: Meget almindelig - ≥ 10 %; Almindelig - > 5 % og < 10 %.
English: The infusion will last approximately 10 minutes.
Danish: Infusionen varer ca. 10 minutter.
English: You should usually receive your infusion once every 3 weeks.
Danish: De vil normalt få indgivet lægemidlet én gang hver tredje uge.
English: Your doctor will discuss with you the potential risk of taking CIAMBRA during pregnancy.
Danish: Deres læge vil sammen med Dem drøfte den potentielle risiko ved at tage CIAMBRA under graviditet.
English: Anaphylactic shock (severe allergic reaction)
Danish: Anafylaktisk chok (alvorlig allergisk reaktion)
English: Your height and weight are measured to work out the surface area of your body.
Danish: Deres højde og vægte måles for at beregne overfladearealet for dit legeme.
English: This is equivalent to 2,7% of the recommended maximum daily dietary intake of sodium for an adult.
Danish: Dette svarer til 2,7% af den anbefalede maximale daglige indtagelse af natrium for en voksen.
English: Based on the planned date of your infusion of CIAMBRA and/or on the status of your kidney function, your doctor needs to advise you on which medicines you can take and when you can take them.
Danish: Ud fra den planlagte dato for Deres infusion af CIAMBRA og/eller status for Deres nyrefunktion skal Deres læge fortælle Dem, hvilke typer medicin De må tage, og hvornår De må tage dem.
English: In vitro studies indicate that pemetrexed is approximately 81 % bound to plasma proteins.
Danish: In vitro-forsøg tyder på, at omtrent 81 % af pemetrexed bindes til plasmaproteiner.
English: Side effects with CIAMBRA may include:
Danish: Bivirkninger med CIAMBRA kan være:
English: It is not known whether pemetrexed is excreted in human milk and adverse reactions on the suckling child cannot be excluded.
Danish: Det er ukendt, om pemetrexed udskilles i human mælk, og en påvirkning af ammende børn kan ikke udelukkes.
English: System organ class
Danish: Organsystem -klasse
English: Not known: frequency cannot be estimated from the available data Lower limb swelling with pain and redness Increased urine output
Danish: Ikke kendt: hyppigheden kan ikke estimeres ud fra forhåndenværende data Hævelse i de nedre lemmer med smerte og rødme Øget urinproduktion
English: The total bilirubin should be ≤ 1.5 times upper limit of normal.
Danish: Total bilirubin skal være ≤ 1,5 gange den normale øvre grænseværdi.
English: Very common side effects (may affect more than 1 in 10 people) Low white blood cells
Danish: Meget almindelige bivirkninger (som kan berøre mere end 1 ud af 10) Lavt antal hvide blodlegemer
English: In the event of neurotoxicity, the recommended dose adjustment for CIAMBRA and cisplatin is documented in Table 3.
Danish: I tilfælde af neurotoksicitet er den anbefalede dosisjustering for CIAMBRA og cisplatin angivet i tabel 3.
English: Subsequent vitamin B12 injections may be given on the same day as pemetrexed.
Danish: De efterfølgende injektioner af B12-vitamin kan gives samme dag som pemetrexed.
English: The infusion of cisplatin will last approximately 2 hours.
Danish: Infusionen af cisplatin via drop tager omkring 2 timer.
English: If you are pregnant, think you may be pregnant or are planning to have a baby,, tell your doctor.
Danish: Hvis De er gravid, har mistanke om, at De er gravid eller planlægger at blive gravid, skal De fortælle det til Deres læge.
English: In vitro studies indicate that pemetrexed is actively secreted by OAT3 (organic anion transporter.
Danish: In vitrostudier indikerer, at pemetrexed udskilles ved aktivt sekretion via OAT3 (organisk aniontransporter).
English: Pemetrexed is primarily eliminated in the urine, with 70 % to 90 % of the administered dose being recovered unchanged in urine within the first 24 hours following administration.
Danish: Pemetrexed udskilles primært med urinen, og 70-90 % af den administrerede dosis kan genfindes uforandret i urinen inden for de første 24 timer efter administration.
English: PFS data were partially confirmed by an independent review (400/1725 patients were randomly selected for review).
Danish: Data for progressionsfri overlevelse data blev delvist bekræftet af en uafhængig undersøgelse (400/1715 patienter blev randomiseret udvalgt til undersøgelsen).
English: The doctor or hospital pharmacist will work out the dose you need based on your height and weight.
Danish: Lægen eller hospitalsapoteket beregner den nødvendige dosis ud fra Deres højde og vægt.
English: Extravasation should be managed by local standard practice as with other non-vesicants.
Danish: Eventuel ekstravasation håndteres i henhold til lokal standardpraksis som med andre ikke-blæretrækkende stoffer.
English: CIAMBRA is a medicine used in the treatment of cancer.
Danish: CIAMBRA er et lægemiddel, der anvendes til behandling af kræft.
English: If necessary, creatinine clearance should be closely monitored.
Danish: Patientens kreatininclearance skal om nødvendigt monitoreres nøje.
English: Response (n: qualified for response) Response rate (%) (95 % CI) Stable disease (%)
Danish: Respons (n: kvalificeret til respons) Responsrate (%) (95 % CI) Stabil sygdom (%)
English: The European Medicines Agency has waived the obligation to submit the results of studies with pemetrexed in all subsets of the paediatric population in the granted indications (see section 4.2).
Danish: Det Europæiske Lægemiddelagentur har dispenseret fra kravet om at fremlægge resultaterne af studier med pemetrexed i alle undergrupper af den pædiatriske population for de godkendte indikationer (se pkt.
English: * Refer to National Cancer Institute CTC version 2 for each grade of toxicity except the term “creatinine clearance decreased” ** Which is derived from the term “renal/genitourinary other”.
Danish: * Se National Cancer Institute CTC version 2 for hver grad af toksicitet, undtagen udtrykket "nedsat kreatininclearance", ** som stammer fra udtrykket "andre renale/genitourinære faktorer".
English: Upon recovery patients should be retreated using the guidelines in Tables 1, 2 and 3, which are applicable for CIAMBRA used as a single agent or in combination with cisplatin.
Danish: Efter rekonvalescens skal patienter efterbehandles ud fra retningslinjerne i tabel 1, 2 og 3, der gælder for brug af CIAMBRA som enkeltstof eller i kombination med cisplatin.
English: Preparation and administration precautions:
Danish: Forsigtighedsregler i forbindelse med forberedelse og administration:
English: Cisplatin is also given by infusion into one of your veins, and is given approximately 30 minutes after the infusion of CIAMBRA has finished.
Danish: Cisplatin indgives også via drop i en af Deres blodårer, cirka 30 minutter efter at infusionen med CIAMBRA er afsluttet.
English: Statistically significant for noninferiority, with the entire confidence interval for HR well below the 1.17645 noninferiority margin (p <0.001).
Danish: Statistisk signifikans for non-inferioritet, med hele konfidensintervallet for HR pænt under 1,17645 marginen for noninferioritet (p <0,001).
English: The effect of third space fluid, such as pleural effusion or ascites, on pemetrexed is not fully defined.
Danish: Effekten af ekstracellulær væske, såsom pleuraeffusion eller ascites, på pemetrexed er ikke fuldt defineret.
English: The high intra-individual variability of the coagulation status during diseases and the possibility of interaction between oral anticoagulants and anticancer chemotherapy require increased frequency of INR (International Normalised Ratio) monitoring, if it is decided to treat the patient with oral anticoagulants.
Danish: Den høje intraindividuelle variation i koagulationsstatus under sygdomsforløb og risikoen for interaktion mellem orale antikoagulantia og kemoterapi mod cancer kræver hyppigere monitorering af INR (International Normalised Ratio), hvis der træffes beslutning om at behandle patienten med orale antikoagulantia.
English: There are no data from the use of pemetrexed in pregnant women but pemetrexed, like other anti-metabolites, is suspected to cause serious birth defects when administered during pregnancy.
Danish: Der er ingen data fra anvendelse af pemetrexed til gravide kvinder, men ligesom andre antimetabolitter formodes pemetrexed at kunne forårsage alvorlige misdannelser, hvis det indgives under graviditeten.
English: It is a white to almost white lyophilised powder.
Danish: Det er et hvidt til næsten hvidt frysetørret pulver.
English: 75 % of previous dose (both CIAMBRA and cisplatin)
Danish: 75 % af tidligere dosis (både CIAMBRA og cisplatin)
English: If you start feeling chest pain or having a fast heart rate.
Danish: Hvis De begynder at føle brystsmerter eller har hjertebanken.
English: To reduce the incidence and severity of skin reactions, a corticosteroid should be given the day prior to, on the day of, and the day after pemetrexed administration.
Danish: For at reducere incidensen og sværhedsgraden af hudreaktioner bør der indgives et kortikosteroidpræparat dagen før, på dagen for og dagen efter administration af pemetrexed.
English: You must take at least 5 doses during the seven days before the first dose of CIAMBRA.
Danish: De skal tage mindst 5 doser i løbet af de 7 dage op til den første dosis CIAMBRA.
English: If you would like to father a child during the treatment or in the 6 months following receipt of treatment, seek advice from your doctor or pharmacist.
Danish: Hvis De ønsker at gøre en kvinde gravid under behandlingsforløbet eller tidligere end 6 måneder, efter behandlingen er stoppet, skal De søge vejledning hos Deres læge eller på apoteket.
English: White to almost white lyophilised powder.
Danish: Hvidt til næsten hvidt frysetørret pulver.
English: Allergic reaction: if you develop skin rash / burning or prickling sensation, or fever.
Danish: Allergisk reaktion: Hvis De udvikler udslæt/en brændende eller prikkende fornemmelse eller feber.
English: Before each infusion you will have samples of your blood taken to evaluate if you have sufficient kidney and liver function and to check that you have enough blood cells to receive CIAMBRA.
Danish: Før hver infusion vil De få taget blodprøver til vurdering af, om Deres nyre- og leverfunktion er tilstrækkelig god, og for at kontrollere, om De har blodlegemer nok til at få CIAMBRA.
English: Due to the gastrointestinal toxicity of pemetrexed given in combination with cisplatin, severe dehydration has been observed.
Danish: Grundet den gastrointestinale toksicitet af pemetrexed i kombinationsbehandling med cisplatin er der observeret svær dehydrering.
English: CIAMBRA must only be administered under the supervision of a physician qualified in the use of anticancer chemotherapy.
Danish: CIAMBRA må kun administreres under tilsyn af en læge, som er kvalificeret i brugen af kemoterapi mod cancer.
English: This medicinal product contains 54 mg sodium per vial , equivalent to 2,7% of the WHO recommended maximum daily intake of 2 g sodium for an adult.
Danish: Dette lægemiddel indeholder 54 mg natrium pr. hætteglas, svarende til 2,7% af den WHO anbefalede maximale daglige indtagelse af 2 g natrium for en voksen.
English: Talk to your doctor or pharmacist before receiving CIAMBRA.
Danish: Kontakt lægen eller apotekspersonalet, før De bruger CIAMBRA.
English: Calculate the dose and the number of CIAMBRA vials needed.
Danish: Beregn den nødvendige dosis og det nødvendige antal hætteglas med CIAMBRA.
English: The independent review of patient scans confirmed the findings of the investigator assessment of PFS.
Danish: Den uafhængige evaluering af patienternes skanninger bekræftede investigatorernes vurdering af progressionsfri overlevelse.
English: The analysis of the impact of NSCLC histology on overall survival demonstrated clinically relevant differences in survival according to histology, see table below.
Danish: Analysen af indvirkningen på NSCLC histologien for total overlevelse viste klinisk relevante forskelle i overlevelse baseret på histologi, se nedenstående tabel.
English: Do not use CIAMBRA
Danish: Brug ikke CIAMBRA:
English: Survival time (months) Median (m)
Danish: Overlevelsestid (måneder) Median (m)
English: Fully supplemented patients
Danish: Patienter med fuldt tilskud
English: ** In the pemetrexed /cisplatin arm, randomized and treated (N = 225) and fully supplemented (N = 167)
Danish: ** I pemetrexed/cisplatin-armen, randomiseret og behandlet (n=225) og fuldt tilskud (n=167)
English: You will always receive CIAMBRA by infusion into one of your veins.
Danish: De vil altid få CIAMBRA via drop i en af Deres blodårer.
English: At the time of this final survival analysis, 28.7% of patients were alive or lost to follow up on the pemetrexed arm versus 21.7% on the placebo arm.
Danish: På tidspunktet for den endelige analyse af den totale overlevelse var 28,7 % af patienterne i pemetrexed-armen i live eller kunne ikke følges op versus 21,7 % i placeboarmen.
English: 06861 Dessau-Rosslau
Danish: 06861 Dessau-Rosslau Tyskland
English: Corticosteroids: your doctor will prescribe you steroid tablets (equivalent to 4 milligram of dexamethasone twice a day) that you will need to take on the day before, on the day of, and the day after CIAMBRA treatment.
Danish: Kortikosteroider: Deres læge vil udskrive steroidtabletter til Dem (svarende til 4 milligram dexamethason 2 gange dagligt), som De skal tage på dagen før, på behandlingsdagen og dagen efter behandling med CIAMBRA.
English: 06861 Dessau-Roßlau Germany
Danish: 06861 Dessau-Roßlau Tyskland
English: Progression free survival (months) Median
Danish: Progressionsfri overlevelse (måneder) Median
English: Infection (sepsis) may be severe and could lead to death.
Danish: En infektion (sepsis, dvs. blodforgiftning) kan være alvorlig og kan medføre døden.
English: Adjusted hazard ratio (HR) (95% CI)
Danish: Justeret hazard ratio (HR) (95 % CI)
English: Pemetrexed infusion solutions prepared as directed above are compatible with polyvinyl chloride and polyolefin lined administration sets and infusion bags.
Danish: Pemetrexedinfusionsopløsninger, der er forberedt som angivet ovenfor, er kompatible med administrationssæt og dropposer, som er belagt med polyvinylchlorid og polyolefin.
English: Abbreviations: CI = confidence interval; HR = hazard ratio; ITT = intent to treat; n = total population size.
Danish: Forkortelser: CI = konfidensinterval; HR = hazard-ratio; ITT = Intent-To-Treat; n = samlet populationsstørrelse.
English: The pemetrexed maintenance safety profiles from the two studies JMEN and PARAMOUNT were similar.
Danish: Sikkerhedsprofilerne for vedligeholdelsesbehandlingen med pemetrexed var sammenlignelige i de to studier JMEN og PARAMOUNT.
English: If you have an accumulation of fluid around your lungs, your doctor may decide to remove the fluid before giving you CIAMBRA.
Danish: Hvis De har en væskeansamling omkring lungerne, vil lægen muligvis beslutte at fjerne denne væske, før De bliver behandlet med CIAMBRA.
English: - The active substance is pemetrexed.
Danish: Aktivt stof: Pemetrexed.
English: Administration of pemetrexed to pregnant mice resulted in decreased foetal viability, decreased foetal weight, incomplete ossification of some skeletal structures and cleft palate.
Danish: Administration af pemetrexed til gravide mus resulterede i lavere føtal levedygtighed, lavere føtal fødselsvægt, ufuldstændig forbening af visse skeletstrukturer og ganespalte.
English: Efficacy of pemetrexed vs docetaxel in NSCLC - ITT population Pemetrexed
Danish: Effekt af pemetrexed versus docetaxel hos NSCLC - ITT-population Pemetrexed
English: If you have pain, redness, swelling or sores in your mouth.
Danish: Hvis De har smerter, rødmen, hævelse eller sår i munden.