FrancophonIA/ELRC3.0 huggingface dataset:
English: ZIMULTI should not be used in patients who may be hypersensitive (allergic) to rimonabant or any of the other ingredients, or in women who are breast feeding.
Danish: ZIMULTI bør ikke anvendes til patienter, der kan være overfølsomme (allergiske) over for rimonabant eller andre af indholdsstofferne, eller af patienter, som ammer.
English: For the full list of all side effects reported with ZIMULTI, see the Package Leaflet.
Danish: Den fuldstændige liste over indberettede bivirkninger ved ZIMULTI fremgår af indlægssedlen.
English: What is ZIMULTI?
Danish: Hvad er ZIMULTI?
English: Four studies of ZIMULTI as a help to stop smoking were also carried out in over 7,000 patients, comparing it with placebo, and measuring the effect of the medicine given for 10 weeks (one year in one of the studies) on smoking cessation, and on relapses in the following year.
Danish: Undersøgelserne, der omfattede over 7 000 patienter, sammenlignede lægemidlet med placebo og målte virkningen af behandlinger på 10 uger (et år i nogle af undersøgelserne) med hensyn til opnåelse af rygestop og tilbagefald det følgende år.
English: EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) ZIMULTI EPAR summary for the public
Danish: EPAR - sammendrag for offentligheden
English: How has ZIMULTI been studied?
Danish: Hvordan blev ZIMULTI undersøgt?
English: What is ZIMULTI used for?
Danish: Hvad anvendes ZIMULTI til?
English: • who are overweight (with a BMI greater than or equal to 27 kg/m²) and also have other risk factors,
Danish: • som er overvægtige (med et BMI større end eller lig med 27 kg/m²), og som også har en eller flere andre risikofaktorer som f.eks. type 2-diabetes eller dyslipidæmi (unormalt højt fedtindhold i blodet).
English: How is ZIMULTI used?
Danish: Hvordan anvendes ZIMULTI?
English: What benefit has ZIMULTI shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved ZIMULTI?
English: How does ZIMULTI work?
Danish: Hvordan virker ZIMULTI?
English: The following key elements should be included in the educational materials:
Danish: Følgende hovedelementer skal inkluderes i informationsmaterialet:
English: − You should be screened for skin type
Danish: − Du skal screenes for hudtype.
English: The Member States shall ensure that all conditions or restrictions with regard to the safe and effective use of the medicinal product described below are implemented:
Danish: Medlemsstaterne skal sikre, at alle betingelser eller begrænsninger med hensyn til en sikker og virkningsfuld anvendelse af det nedenfor nævnte lægemiddel implementeres:
English: The Member States shall agree the details educational materials with the MAH according to national regulations and healthcare systems and ensure that it is implemented nationally so that all health care professionals who intend to prescribe and/or dispense PhotoBarr are provided with the following:
Danish: Medlemsstaterne skal aftale detaljerne vedrørende uddannelsesmaterialer med indehaveren af markedsføringstilladelsen i overensstemmelse med de nationale bestemmelser og sundhedssystemer og sikre, at det implementeres på nationalt plan, således at alle sundhedspersoner, der skal ordinere og/eller uddele PhotoBarr, er forsynet med følgende:
English: • Prescriber guide
Danish: • Ordinationsvejledning
English: • Healthcare professionals administration and monitoring guide
Danish: • Administrations- og monitoreringsvejledning for professionelt sundhedspersonale
English: − Photosensitivity can only be prevented by avoiding exposure to the sun for 90 days after receiving the PhotoBarr injection
Danish: o Lysfølsomhed kan kun forebygges ved at undgå udsættelse for sol i 90 dage efter at have modtaget injektionen med PhotoBarr.
English: o Commercially available sun blocks are not effective in preventing sensitivity due to
Danish: o Almindelige solbeskyttelsesmidler på markedet forebygger ikke effektivt følsomhed over for lys.
English: − Brief background and introduction to Barrett's oesophagus and high grade dysplasia
Danish: Patientvejledning − Kort baggrundsbeskrivelse og introduktion af Barrets øsofagus og højt
English: o all patients should know that UV blocking is not effective in blocking visible light o Patients should be aware of potential risk factors (skin phototype and hepatic o Patients should be instructed to seek medical advice if signs/symptoms suggestive of photosensitivity occur during or after therapy with porfimer.
Danish: o Patienterne skal kende til potentielle risikofaktorer (hudfølsomhedstype og o Patienterne skal have besked på at søge læge, hvis der opstår tegn/symptomer, der tyder på lysfølsomhed, under eller efter terapi med porfimer.
English: − Before initiating therapy, o The patient should be screened for skin type o Patients should be aware of the long half-life of porfimer and that the compound gets o Patients should avoid being exposed to light for 60-90 days post-exposure.
Danish: o Patienterne skal være klar over, at porfimer har en lang halveringstid, samt at o Patienterne skal undgå at udsætte sig for lys i 60-90 dage efter eksponering.
English: − It is important to follow exactly the correct steps for reconstitution and administration of porfimer.
Danish: Administrations- og monitoreringsvejledning til sundhedspersoner − Det er vigtigt at følge de korrekte trin til rekonstitution og administration af
English: − You should not be treated with PhotoBarr if you have severe liver disease (eg cirrhosis)
Danish: − Du kan ikke få behandling med PhotoBarr, hvis du har en alvorlig leversygdom
English: o they have trachea or broncho-oesophageal fistulas.
Danish: Ordinationsvejledning og ordinationspræparatsæt − Informationsredskaberne er udarbejdet til at hjælpe lægerne med at optimere o de har en tracheo-øsofageal eller broncho-øsofageal fistel.
English: • Patient alert card
Danish: • Ordinationspræparatsæt
English: It is given as a single injection into the muscle behind the ear of piglets between 48 and 72 hours old.
Danish: Det gives som en enkelt injektion i musklen bag øret på pattegrisene, når de er mellem 48 og 72 timer gamle.
English: Baycox Iron received a marketing authorisation valid throughout the EU on 20 May 2019.
Danish: Baycox Iron modtog en markedsføringstilladelse med gyldighed i hele EU den 20. maj 2019.
English: The withdrawal period for meat from pigs treated with Baycox Iron is 53 days.
Danish: Tilbageholdelsestiden for kød fra svin, der behandles med Baycox Iron, er 53 dage.
English: Further information on Baycox Iron can be found on the Agency's website: ema.europa.eu/medicines/veterinary/EPAR/baycox-iron.
Danish: Yderligere oplysninger om Baycox Iron findes på agenturets websted under: ema.europa.eu/medicines/veterinary/EPAR/baycox-iron.
English: Baycox Iron may be harmful for the unborn child.
Danish: Baycox Iron kan være skadeligt for det ufødte barn.
English: Toltrazuril is an antiparastic medicine which interferes with the enzymes needed by coccidia parasites to produce energy.
Danish: Toltrazuril er et antiparasitært lægemiddel, som påvirker de enzymer, der er nødvendige for, at coccidiaparasitterne kan producere energi.
English: Coccidiosis is a disease of the gut which results in reduced growth due to diarrhoea.
Danish: Coccidiose er en tarmsygdom, der medfører nedsat vækst på grund af diarré.
English: People who are hypersensitive (allergic) to iron compounds or toltrazuril should avoid contact with Baycox Iron.
Danish: Personer, som er overfølsomme (allergiske) over for jernforbindelser eller toltrazuril, bør undgå kontakt med Baycox Iron.
English: The European Medicines Agency decided that Baycox Iron's benefits are greater than its risks and it can be authorised for use in the EU.
Danish: Det Europæiske Lægemiddelagentur konkluderede, at fordelene ved Baycox Iron opvejer risiciene, og at det kan godkendes til anvendelse i EU.
English: Iron is an essential nutrient needed to make haemoglobin to transport oxygen in the blood, as well as certain key enzymes, and without additional iron, piglets raised under intensive farming conditions will develop anaemia within 10 days after birth.
Danish: Jern er et essentielt næringsstof, der er nødvendigt for at danne hæmoglobin til at transportere ilt i blodet, samt visse vigtige enzymer, og uden yderligere jern vil pattegrise ved intensivt opdræt udvikle anæmi inden for 10 dage efter fødslen.
English: It is used in young piglets on farms which have been affected in the past by the parasitic infection coccidiosis to prevent diarrhoea caused by a new coccidiosis infection.
Danish: Det anvendes til pattegrise på bedrifter, der tidligere har været ramt af parasitinfektionen coccidiose, til at forebygge diarré forårsaget af en ny coccidioseinfektion.
English: For more information about using Baycox Iron, see the package leaflet or contact your veterinarian or pharmacist.
Danish: Hvis du ønsker flere oplysninger om anvendelsen af Baycox Iron, kan du læse indlægssedlen eller kontakte din dyrlæge eller dit apotek.
English: Following injection into the muscle, gleptoferron is absorbed and broken down to release iron for use and/or storage depending on the need for iron in suckling piglets.
Danish: Efter injektion i musklen optages gleptoferron, og det nedbrydes og frigiver jern til brug og/eller lagring afhængigt af pattegrisenes jernbehov.
English: Other information about Baycox Iron
Danish: Andre oplysninger om Baycox Iron
English: Infected piglets shed disease spores (oocysts) in their faeces that can spread the infection.
Danish: Inficerede pattegrise udskiller sygdomssporer (oocyster) i afføringen, hvilket kan sprede infektionen.
English: In a field study performed in 3 EU countries and involving 968 piglets on farms with a history of coccidiosis, a single intramuscular injection of Baycox Iron given at 3 days of age was effective in preventing iron deficiency anaemia, and reducing oocyst excretion and diarrhoea associated with coccidiosis caused by the coccidia parasite Cystoisospora suis, in comparison with giving iron only (as gleptoferron) at 3 days of age.
Danish: I et feltstudie udført i tre EU-lande med 968 pattegrise på bedrifter med tidligere forekomst af coccidiose, var en enkelt intramuskulær injektion af Baycox Iron, indgivet når pattegrisene var 3 dage gamle, effektivt til at forebygge jernmangelanæmi samt nedsætte oocystudskillelsen og forekomsten af diarré i forbindelse med coccidiose forårsaget af coccidiaparasitten Cystoisospora suissammenlignet med jern givet alene (som gleptoferron) i 3-dagesalderen.
English: Baycox Iron is a veterinary medicine.
Danish: Baycox Iron er et lægemiddel til dyr.
English: The most common side effects with Baycox Iron (which may affect up to 1 in 10 piglets) are short-lived tissue discolouration and slight swelling at the injection site.
Danish: De hyppigste bivirkninger ved Baycox Iron (som kan optræde hos op til 1 ud af 10 pattegrise) er en forbigående misfarvning af vævet og en let hævelse ved injektionsstedet.
English: Baycox Iron is also used to reduce spread of the infection through passage of oocysts in faeces, and at the same time to prevent iron deficiency anaemia due to the limited iron reserves of new-born piglets, low iron content of milk and high growth rate of suckling piglets.
Danish: Baycox Iron anvendes også til at begrænse spredningen af infektionen via udskillelse af oocyster i afføring og samtidig forebygge jernmangelanæmi på grund af nyfødte pattegrises begrænsede jernreserver, det lave jernindhold i mælk og pattegrises høje væksthastighed.
English: An overview of Baycox Iron and why it is authorised in the EU
Danish: Oversigt over Baycox Iron, og hvorfor det er godkendt i EU
English: Baycox Iron must not be given to piglets suspected to have insufficient levels of vitamin E or selenium.
Danish: Baycox Iron må ikke gives til pattegrise, som formodes at have for lidt E-vitamin eller selen.
English: Baycox Iron is available as an injection and can only be obtained with a prescription.
Danish: Baycox Iron fås som en injektionsvæske og udleveres kun efter recept.
English: Why is Baycox Iron authorised in the EU?
Danish: Hvorfor blev Baycox Iron godkendt i EU?
English: What is Baycox Iron and what is it used for?
Danish: Hvad er Baycox Iron, og hvad anvendes det til?
English: The other active substance in Baycox Iron, gleptoferron, is an iron-containing compound.
Danish: Det andet aktive stof i Baycox Iron, gleptoferron, er en jernholdig forbindelse.
English: For the full list of side effects and restrictions of Baycox Iron, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger og begrænsninger ved Baycox Iron fremgår af indlægssedlen.
English: What are the risks associated with Baycox Iron?
Danish: Hvilken risiko er der forbundet med Baycox Iron?
English: Baycox Iron contains the active substances toltrazuril and gleptoferron (an iron-containing compound).
Danish: Baycox Iron indeholder de aktive stoffer toltrazuril og gleptoferron (en jernholdig forbindelse).
English: How is Baycox Iron used?
Danish: Hvordan anvendes Baycox Iron?
English: How does Baycox Iron work?
Danish: Hvordan virker Baycox Iron?
English: What benefits of Baycox Iron have been shown in studies?
Danish: Hvilke fordele viser studierne, at der er ved Baycox Iron?
English: Applicant company name, address
Danish: Ansøgervirksomhedens navn, adresse
English: The Netherlands Geiser Pharma, S.L.
Danish: Nederlandene Geiser Pharma, S.L.
English: Pharmaceutical form
Danish: Lægemiddelform Administration
English: Mentocaína Spray 8.75 mg/dose Oromucosal spray, solution
Danish: Mentocaína Spray 8.75 mg/dose Mundhulespray, opløsning
English: Flurbiprofen Sejmet 8.75 mg/dose Oromucosal spray, solution
Danish: Flurbiprofen Sejmet 8.75 mg/dose Mundhulespray, opløsning
English: For each of these parameters, the increases were severe in 1% of cases.
Danish: For hver af disse parametre var øgningerne alvorlige i 1 % af tilfældene.
English: Unopened vial: 2 years.
Danish: Uåbnet hætteglas: 2 år.
English: There is limited information to support treatment of this condition.
Danish: Der er begrænset information til at understøtte behandling af denne tilstand.
English: The following information is intended for medical or healthcare professionals only:
Danish: Følgende oplysninger er udelukkende beregnet til læger eller sygeplejersker:
English: More than half of the responses were apparent after the first three cycles of treatment.
Danish: Over halvdelen af det samlede respons var tydeligt efter de første tre behandlingsforløb.
English: • The levels of some enzymes in your blood might rise
Danish: • Niveauerne af nogle enzymer i blodet kan stige
English: • Bad taste in your mouth
Danish: • Dårlig smag i munden
English: If necessary, your doctor will adjust the dosage during the treatment.
Danish: Om nødvendigt vil din læge justere doseringen under behandlingen.
English: Thus it may not be safe for you to drive or to use machines for up to several hours after you have had your treatment.
Danish: Derfor vil det måske ikke være sikkert for dig at køre bil eller betjene maskiner i op til flere timer, efter at du har modtaget en behandling.
English: • Painful sensation in the body
Danish: • Smertefuld fornemmelse i kroppen
English: These agents are used to treat cancer.
Danish: Disse lægemidler bruges til behandling af kræft.
English: In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
Danish: Da der ikke findes undersøgelser af forligelighed, bør dette lægemiddel ikke blandes med andre lægemidler.
English: Each infusion contains up to 21 g of alcohol.
Danish: Hver infusion indeholder ca. 21 g alkohol.
English: Paxene contains alcohol.
Danish: Paxene indeholder alkohol.
English: Therefore, frequent complete blood counts should be performed on all patients during treatment.
Danish: Derfor bør der ofte gennemføres komplette blodtællinger hos alle patienter under behandling.
English: Patients should be observed closely during the initial cycles of treatment.
Danish: Patienterne bør observeres omhyggeligt under de første omgange af behandlingen.
English: • are taking other medicines that you have bought for yourself without a prescription.
Danish: • bruger anden medicin, som du selv har købt uden recept.
English: This subgroup of patients is considered to constitute the core efficacy population.
Danish: Denne undergruppe af patienter anses for at udgøre kernegruppen for effekt.
English: In the event of an overdose, the patient should be closely monitored.
Danish: I tilfælde af overdosis bør patienten observeres meget nøje.
English: Based on in vitro studies, the degree of plasma protein binding has been reported to range from 88 to 98 %.
Danish: På baggrund af in vitro-undersøgelser er niveauet af plasmaproteinbinding blevet rapporteret til at være i intervallet 88 - 98 %.
English: In the study, the majority of patients were administered granulocyte colony stimulating factor (G-CSF).
Danish: I undersøgelsen fik hovedparten af patienterne administreret granulocytkoloni-stimulerende faktor (G-CSF).
English: 19 % of patients had severe neutropenia for > 7 days.
Danish: 19 % af patienterne havde svær neutropeni i >7 dage.
English: Limited efficacy data supports this indication (see section 5.1).
Danish: Begrænsede effektivitetsdata understøtter denne indikation (se pkt.
English: BATCH NUMBER Batch Number:
Danish: BATCHNUMMER Batchnummer:
English: Very common: hypotension
Danish: Meget almindelig: Hypotension
English: Safety and efficacy in children and adolescents (under 18 years) has not been established.
Danish: Sikkerhed og effekt er ikke påvist for børn og unge (under 18 år).
English: Dose adjustments during treatment
Danish: Justering af dosis under behandlingen
English: Of the 107 patients, 63 patients were considered resistant to liposomal anthracyclines.
Danish: Ud af de 107 patienter blev 63 patienter anset for at være resistente overfor liposomale anthracykliner.
English: As the AIDS-KS population is very specific, safety data from a clinical study of 107 AIDS-KS patients are presented separately at the end of this section.
Danish: Da aids-KS populationen er meget specifik, præsenteres sikkerhedsdata fra en klinisk undersøgelse af 107 aids-KS patienter for sig selv i slutningen af dette punkt.
English: The primary endpoint was best tumour response.
Danish: Det primære endpoint var bedste tumorrespons.
English: Check with your doctor.
Danish: Spørg lægen.
English: Stabilisation results in the inhibition of the normal dynamic reorganisation of the microtubular network that is essential for vital interphase and mitotic cellular functions.
Danish: Stabilisering resulterer i inhibition af den normale dynamiske reorganisering af det microtubulare netværk, som er essentielt for den vitale interfase og de mitotiske cellefunktioner.
English: Pharmacotherapeutic group: taxanes, ATC code: L01CD01.
Danish: Farmakoterapeutisk klassifikation: Taxaner, ATC-kode: L01CD01
English: • If you are taking other medicines which could interact with paclitaxel (see Using other medicines).
Danish: • Hvis du tager andre lægemidler, der kan give interaktion med paclitaxel (se Brug af anden medicin).
English: Date of latest renewal: 19th July 2009
Danish: Dato for første markedsføring: 19. juli 1999 Dato for seneste fornyelse: 19. juli 2009
English: The amount of alcohol in this medicine may alter the effects of other medicines and should be taken into account in patients with liver disease or epilepsy.
Danish: Mængden af alkohol i dette lægemiddel kan ændre virkningen af andre lægemidler, og dette skal tages i betragtning hos patienter med leversygdom eller epilepsi.
English: The use of gloves, goggles and protective clothing is recommended.
Danish: Brug af handsker, beskyttelsesbriller og beskyttelsestøj anbefales.
English: The active substance of Paxene is paclitaxel.
Danish: Den aktive substans i Paxene er paclitaxel.
English: Detailed information on this medicine is available on the European Medicines Agency (EMEA) web site: http://www.emea.europa.eu.
Danish: Yderligere information om dette lægemiddel er tilgængelig på Det europæiske Lægemiddelagenturs (EMEAs) hjemmeside http://www.emea.europa.eu/.
English: Therefore, frequent monitoring of vital signs during the first hours of Paxene infusion is recommended.
Danish: Hyppig observation af vitale funktioner i løbet af de første timer af infusionen med Paxene anbefales derfor.
English: Neutropenia was present for > 7 days in 41 % and for 30 - 35 days in 8 % of patients.
Danish: Neutropeni var tilstede i >7 dage hos 41 % og i 30 - 35 dage hos 8 % af patienterne.
English: The disposition of paclitaxel is non-linear (concentration dependent) as the systemic exposure increases more than expected following an increase in dosage.
Danish: Fordelingen af paclitaxel er ikke-lineær (koncentrationafhængigt), da den systemiske eksponering øges mere end forventet efter en stigning i doseringen.
English: No data are available for patients with severe baseline cholestasis.
Danish: Der findes ingen tilgængelige data for patienter med svær baseline cholestase.
English: The median time to progression in the core population was 468 days (95 % CI 257-NE).
Danish: Mediantiden for progression i kernepopulationen var 468 dage (95 % CI 257-NE).
English: The other most commonly reported nervous system disorder is somnolence, which affected 14 % of patients.
Danish: De andre mest almindeligt rapporterede sygdomme i nervesystemet er somnolens, som påvirkede 14 % af patienterne.
English: Red cell transfusions were required in 21 % of patients.
Danish: Transfusion af røde blodlegemer var påkrævet hos 21 % af patienterne.
English: Side-effects may occur while you are receiving Paxene or following treatment.
Danish: Der kan opstå bivirkninger, mens du modtager Paxene eller efter behandling.
English: To help prevent allergic reactions occurring while you are receiving your infusion you will be given medication before your treatment starts.
Danish: For at forebygge allergiske reaktioner, mens du modtager din infusion, giver man dig medicin inden behandlingen.
English: Patients with hepatic impairment may be at increased risk of toxicity, particularly Grade 3-4 myelosuppression.
Danish: Patienter med nedsat leverfunktion kan eventuelt have øget risiko for toksicitet, især grad 3-4 myelosuppression.
English: • Loosening of finger and toe nails - you should wear protection on your feet and hands when exposed to the sun
Danish: • Tab af finger- og tånegle - du skal bære beskyttelse på fødder og hænder, når du er udsat for sol
English: Like other genotoxic cytostatics, paclitaxel can have genotoxic effects.
Danish: Som andre genotoksi ske cytostatika kan paclitaxel have genotoksiske virkninger.
English: In spite of this high protein binding, paclitaxel is widely distributed to tissues.
Danish: På trods af denne høje proteinbinding fordeles paclitaxel i høj grad til vævene.
English: However, paclitaxel belongs to a class of substances which are potentially carcinogenic based on their mechanism of action.
Danish: Paclitaxel tilhører imidlertid en klasse substanser, som er potentielt carcinogene på basis af deres virkningsmekanisme.
English: This may be a sign of a serious bowel inflammation (pseudomembranous colitis).
Danish: Dette kan være tegn på alvorlig tarmbetændelse (pseudomembranøs colitis).
English: Although other dose regimens/combinations are under investigation, a combination regimen of Paxene and cisplatin is recommended.
Danish: Selvom andre doseringsregimer/kombinationer er ved at blive undersøgt, anbefales et kombinationsregimen af Paxene og cisplatin.
English: During treatment, you should tell the medical staff if you feel unwell.
Danish: Under behandlingen skal du fortælle personalet, hvis du bliver utilpas.
English: Median survival for Paxene could not be computed, but the lower 95 % bound was 617 days in core patients.
Danish: Median overlevelse for Paxene kunne ikke beregnes, men den nedre 95 % grænse var 617 dage hos kernepatienter.
English: Patients should be closely monitored for the development of profound myelosuppression (see section 4.2).
Danish: Patienterne bør overvåges nøje for udvikling af alvorlig myelosuppression (se pkt.