FrancophonIA/ELRC3.0 huggingface dataset:
English: The active substance in Methylthioninium chloride Proveblue, methylthioninium chloride (also called methylene blue), helps speed up the conversion of abnormal haemoglobin back into normal haemoglobin.
Danish: Det aktive stof i Methylthioniniumchlorid Proveblue, methylthioniniumchlorid (også kaldet methylenblåt), hjælper med at fremskynde omdannelsen af unormalt hæmoglobin tilbage til normalt hæmoglobin.
English: For more information about treatment with Methylthioninium chloride Proveblue, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Methylthioniniumchlorid Proveblue, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: Methaemoglobinaemia is a condition where there is too much of an abnormal form of haemoglobin (called methaemoglobin) in the blood that is not able to transport oxygen effectively.
Danish: Methæmoglobinæmi er en lidelse, hvor blodet indeholder for meget af en unormal form af hæmoglobin (kaldet methæmoglobin), der ikke kan transportere ilt effektivt.
English: The reference medicine for Methylthioninium chloride Proveblue is Methylthioninium Chloride Injection USP 1% w/v.
Danish: Referencelægemidlet for Methylthioniniumchlorid Proveblue er Methylthioniniumchlorid Injection USP 1 % w/v.
English: To carry oxygen in the blood, haemoglobin needs to contain an atom of iron in the ‘ferrous' form (Fe2+).
Danish: Hæmoglobin skal for at kunne transportere ilt i blodet indeholde et jernatom i "ferro"-form (Fe2+).
English: The CHMP decided that the medicine's benefits are greater than its risks and recommended that it be given marketing authorisation.
Danish: CHMP besluttede, at fordelene ved lægemidlet opvejer risiciene, og anbefalede udstedelse af en markedsføringstilladelse for Methylthioniniumchlorid Proveblue.
English: • methaemoglobinaemia caused by chlorate poisoning,
Danish: • methæmoglobinæmi fremkaldt af chloratforgiftning
English: What measures are being taken to ensure the safe and effective use of Methylthioninium chloride Proveblue?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Methylthioniniumchlorid Proveblue?
English: For practical information about using Methylthioninium chloride Proveblue, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Methylthioniniumchlorid Proveblue, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: Methylthioninium chloride Proveblue is a ‘hybrid medicine'.
Danish: Methylthioniniumchlorid Proveblue et " hybrid lægemiddel ".
English: What is Methylthioninium chloride Proveblue and what is it used for?
Danish: Hvad er Methylthioniniumchlorid Proveblue, og hvad anvendes det til?
English: Methylthioninium chloride Proveblue contains the active substance methylthioninium chloride.
Danish: Methylthioniniumchlorid Proveblue indeholder det aktive stof methylthioniniumchlorid.
English: For the full list of all side effects reported with methylthioninium chloride, see the package leaflet.
Danish: Den fuldstændige liste over indberettede bivirkninger ved methylthioniniumchlorid fremgår af indlægssedlen.
English: Methylthioninium chloride Proveblue methylthioninium chloride
Danish: Methylthioniniumchlorid Proveblue methylthioniniumchlorid
English: Other information about Methylthioninium chloride Proveblue
Danish: Andre oplysninger om Methylthioniniumchlorid Proveblue
English: It is not intended to provide practical advice on how to use Methylthioninium chloride Proveblue
Danish: Det er ikke en praktisk vejledning i, hvordan Methylthioniniumchlorid Proveblue bør anvendes.
English: Why is Methylthioninium chloride Proveblue approved?
Danish: Hvorfor er Methylthioniniumchlorid Proveblue godkendt?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Methylthioninium chloride Proveblue have been included in the summary of product characteristics and the package leaflet.
Danish: Der er anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Methylthioniniumchlorid Proveblue.
English: What are the risks associated with Methylthioninium chloride Proveblue?
Danish: Hvilke risici er der forbundet med Methylthioniniumchlorid Proveblue?
English: How is Methylthioninium chloride Proveblue used?
Danish: Hvordan anvendes Methylthioniniumchlorid Proveblue?
English: What benefits of Methylthioninium chloride Proveblue have been shown in studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Methylthioniniumchlorid Proveblue?
English: Your doctor will decide whether or not you should be given this medicine.
Danish: Din læge vil afgøre, om du skal have denne medicin.
English: Iron deficiency anaemia occurring in the first trimester of pregnancy can in many cases be treated with oral iron.
Danish: Jernmangelanæmi i første trimester af graviditeten kan i mange tilfælde behandles med oralt jern.
English: If hypersensitivity reactions or signs of intolerance occur during administration, the treatment must be stopped immediately.
Danish: Hvis der opstår overfølsomhedsreaktioner eller tegn på intolerans under administrationen, skal behandlingen stoppes øjeblikkeligt.
English: It is important to tell your doctor if you are pregnant, think you may be pregnant, or are planning to have a baby.
Danish: Det er vigtigt, at du fortæller din læge, hvis du er gravid, har mistanke om, at du er gravid, eller planlægger at blive gravid.
English: Treatment with {invented name} should be confined to second and third trimester if the benefit is judged to outweigh the potential risk for both the mother and the foetus.
Danish: Behandling med {særnavn} bør begrænses til andet og tredje trimester, hvis fordelen vurderes at veje tungere end den potentielle risiko for både mor og foster.
English: Annex III Amendments to relevant sections of the summary of product characteristics and package leaflets
Danish: Bilag III Ændringer til relevante punkter i produktresumeet og indlægssedlen
English: [All references to the recommendation for an initial test dose before the administration of the first dose to a new patient should be removed in section 4.2 and in any other sections of the SmPC where applicable.
Danish: [Enhver reference knyttet til anbefalingen af en initialtestdosis før indgivelsen af den første dosis hos en ny patient, skal fjernes fra afsnit 4.2 og i alle andre afsnit af produktresumeet, hvor det er relevant.
English: The current information on subsequent doses/administration of the product, including for example slower initial rate of administration, should remain unchanged]
Danish: Den aktuelle information om efterfølgende doser/indgivelser af produktet, herunder en langsommere indgivelseshastighed, bør ikke ændres.]
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: Additional treatment with antihistamines and/or corticosteroids should be given as appropriate.
Danish: Yderligere behandling med antihistaminer og/eller kortikosteroider skal gives efter behov.
English: If you become pregnant during treatment, you must ask your doctor for advice.
Danish: Hvis du bliver gravid under behandlingen, skal du spørge din læge til råds.
English: {invented name} has not been tested in pregnant women.
Danish: { særnavn } er ikke undersøgt hos gravide kvinder.
English: There are no adequate and well-controlled trials of {invented name} in pregnant women.
Danish: Der findes ingen tilstrækkelige og velkontrollerede forsøg med {særnavn} hos gravide kvinder.
English: A careful risk/benefit evaluation is therefore required before use during pregnancy and {invented name} should not be used during pregnancy unless clearly necessary (see section
Danish: Det er derfor nødvendigt omhyggeligt at vurdere fordele og ulemper inden brug under graviditet, og {særnavn} bør ikke anvendes under graviditet, medmindre det er klart nødvendigt (se pkt.
English: Monitor carefully patients for signs and symptoms of hypersensitivity reactions during and following each administration of {invented name}.
Danish: Overvåg omhyggeligt patienten for tegn og symptomer på overfølsomhedsreaktioner under og efter hver administration af {særnavn}.
English: {Invented name} should only be administered when staff trained to evaluate and manage anaphylactic reactions is immediately available, in an environment where full resuscitation facilities can be assured.
Danish: {Særnavn} bør kun administreres, når et personale, der har erfaring med at vurdere og håndtere anafylaktiske reaktioner, er umiddelbart tilgængeligt i et miljø, hvor der er adgang til komplet genoplivningsudstyr.
English: - if you have experienced serious allergic (hypersensitive) reactions to other injectable iron preparations.
Danish: - hvis du har oplevet alvorlige allergiske (overfølsomheds) reaktioner på andre injicerbare jernpræparater.
English: • Known serious hypersensitivity to other parenteral iron products.
Danish: • Kendt alvorlig overfølsomhed over for andre parenterale jernpræparater.
English: There is also an increased risk of hypersensitivity reactions to parenteral iron complexes in patients with immune or inflammatory conditions (e.g. systemic lupus erythematosus, rheumatoid arthritis).
Danish: Der er også en øget risiko for overfølsomhedsreaktioner på parenterale jernkomplekser hos patienter med immunologiske eller inflammatoriske tilstande (f.eks. systemisk lupus erythematosus, reumatoid artritis).
English: You will be observed for at least 30 minutes by your doctor or nurse after each administration.
Danish: Du vil blive overvåget i mindst 30 minutter af lægen eller en sygeplejerske efter hver injektion.
English: The risk is enhanced for patients with known allergies including drug allergies, including patients with a history of severe asthma, eczema or other atopic allergy.
Danish: Risikoen er højere for patienter med kendte allergier, herunder lægemiddelallergier, og hos patienter, der lider af svær astma, eksem eller anden atopisk allergi.
English: You must not receive {invented name}: - if you are allergic (hypersensitive) to the product or any of the other ingredients of this medicine (listed in section 6).
Danish: Du må ikke få {særnavn}: - hvis du er allergisk (overfølsom) over for det aktive stof eller et af de øvrige indholdsstoffer i {særnavn} (angivet i punkt 6).
English: Talk to your doctor or nurse before receiving {invented name}: - if you have a history of medicine allergy - if you have systemic lupus erythematosus - if you have rheumatoid arthritis - if you have severe asthma, eczema or other allergies
Danish: Advarsler og forsigtighedsregler Tal med din læge eller sygeplejerske, inden du får {særnavn}: - hvis du lider af lægemiddelallergi - hvis du har systemisk lupus erythematosus - hvis du har reumatoid artritis - hvis du lider af astma, eksem eller andre allergier
English: How {invented name} is given
Danish: Sådan får du {særnavn}
English: You can also report side effects directly via {the national reporting system listed in Appendix V}*.
Danish: Du kan også indberette bivirkninger direkte til Sundhedsstyrelsen via det nationale rapporteringssystem anført i Appendiks V*.
English: Healthcare professionals are asked to report any suspected adverse reactions {via the national reporting system listed in Appendix V*}.
Danish: Læger og sundhedspersonale anmodes om at indberette alle formodede bivirkninger via det nationale rapporteringssystem anført i Appendiks V*.
English: If you are breast-feeding, ask your doctor for advice before you are given {invented name}.
Danish: Hvis du ammer, skal du spørge din læge til råds, inden du får {særnavn}.
English: Facilities for cardio respiratory resuscitation and equipment for handling acute anaphylactic/anaphylactoid reactions should be available, including an injectable 1:1000 adrenaline solution.
Danish: Faciliteter til genoplivning (hjertestop, respirationsstop) og udstyr til håndtering af akutte anafylaktiske/anafylaktoide reaktioner skal være tilgængelige, herunder 1 mg/ml adrenalininjektionsvæske.
English: 4.6 Fertility, pregnancy and lactation [the wording below should be inserted in the relevant section]
Danish: 4.6 Fertilitet, graviditet og amning [disse sætninger skal tilføjes i det relevante punkt]
English: What you need to know before you receive {invented name} [the wording below should be inserted in the relevant section]
Danish: Det skal du vide, før du får {særnavn} [disse sætninger skal tilføjes i det relevante punkt]
English: Each patient should be observed for adverse effects for at least 30 minutes following each {invented name} injection.
Danish: Patienten skal observeres for bivirkninger i mindst 30 minutter efter hver {særnavn}-injektion.
English: [the wording below should be inserted in the relevant section]
Danish: [disse sætninger skal tilføjes i det relevante punkt]
English: • Hypersensitivity to the active substance, to {invented name} or any of its excipients listed in section 6.1.
Danish: • Overfølsomhed over for det aktive stof, over for {særnavn} eller over for et eller flere af hjælpestofferne anført i pkt.
English: The patient should be observed for adverse effects for at least 30 minutes following each {invented name} injection (see section 4.4).
Danish: Patienten skal observeres for bivirkninger i mindst 30 minutter efter hver {særnavn}-injektion (se pkt.
English: 4.4 Special warnings and precautions for use [the wording below should be inserted in the relevant section]
Danish: 4.4 Særlige advarsler og forsigtighedsregler vedrørende brugen [disse sætninger skal tilføjes i det relevante punkt]
English: Contraindications [the wording below should be inserted in the relevant section]
Danish: Kontraindikationer [disse sætninger skal tilføjes i det relevante punkt]
English: Your doctor or nurse will administer {invented name} by {route of administration defined in posology section of SmPC}; the {invented name} will be administered in a structure where immunoallergic events can receive appropriate and prompt treatment.
Danish: Din læge eller sygeplejerske vil give dig {særnavn} ved {den administrationsvej, der er angivet i doseringsafsnittet i SmPC}.
English: 4.2 Posology and method of administration [the wording below should be inserted in the relevant section]
Danish: 4.2 Dosering og indgivelsesmåde [disse sætninger skal tilføjes i det relevante punkt]
English: Possible side effects [the wording below should be inserted in the relevant section]
Danish: Bivirkninger [disse sætninger skal tilføjes i det relevante punkt]
English: The risk to humans is not known.
Danish: Risikoen for mennesker kendes ikke.
English: MARKETING AUTHORISATION NUMBER EU/1/12/775/001
Danish: MARKEDSFØRINGSTILLADELSESNUMMER EU/1/12/775/001
English: Before starting, the hands should be washed.
Danish: Inden du starter, skal hænderne vaskes.
English: NovoThirteen can be used for all age groups.
Danish: NovoThirteen kan anvendes hos alle aldersgrupper.
English: None of the reported cases have shown any signs of illness.
Danish: Ingen af de rapporterede tilfælde har udvist tegn på sygdom.
English: The final content, format and distribution modalities of both documents should be agreed with the national competent authority in each Member State.
Danish: Det endelige indhold, format og distributionsmetode af begge dokumenter, skal aftales med de relevante myndigheder i hvert medlemsland.
English: Use in small children
Danish: Brug til små børn
English: The calculation of the correction factor 0.117 is related to the exact quantity of the product and not the nominal value of the product.
Danish: Beregning af korrektionsfaktoren 0,117 er relateret til den præcise mængde af produktet og ikke til den nominelle værdi af produktet.
English: This means your body may be more prone to infections
Danish: Det betyder, at din krop kan være mere følsom over for infektioner
English: Your dose will depend on your body weight.
Danish: Din dosis afhænger af din legemsvægt.
English: • If you have or have ever had liver damage.
Danish: • Hvis du har eller har haft en leverskade.
English: The potency of this medicinal product is expressed in international units (IU).
Danish: Dette lægemiddels styrke udtrykkes i internationale enheder (IE).
English: • Contraindication of hypersensitivity
Danish: • Kontraindikation ved hypersensitivitet
English: • A drop in the number of some types of white blood cells.
Danish: • Et fald i antallet af nogle typer hvide blodlegemer.
English: If a larger dose is needed, repeat the procedure in a separate syringe until the required dose is reached.
Danish: Hvis en større dosis er nødvendig, gentages proceduren i en separat sprøjte, indtil den ønskede dosis er opnået.
English: Leucopenia and aggravated neutropenia
Danish: Leukopeni og forværret neutropeni
English: • The importance of collecting safety data and how to enrol patients in the PASS and other registries
Danish: • Vigtigheden af at indsamle sikkerhedsdata og hvordan patienter bliver registreret i PASS samt andre registre
English: • Pain in the legs and arms
Danish: • Smerter i ben og arme
English: Summary of the safety profile The most frequent adverse reaction is ‘headache' reported in 37% of patients.
Danish: Resumé af sikkerhedsprofilen Den hyppigst forekommende bivirkning er 'hovedpine' der blev rapporteret hos 37% af patienterne.
English: The results of standard coagulation tests are normal, as it is the quality of the clot that is affected.
Danish: Resultaterne af standardkoagulationstest er normale, da det er kvaliteten af koaglet, som bliver påvirket.
English: Store in a refrigerator (2°C-8°C).
Danish: Opbevares i køleskab (2°C˗8°C).
English: If you stop using NovoThirteen, you are not protected against bleeding.
Danish: Hvis du holder op med at bruge NovoThirteen, er du ikke beskyttet mod blødning.
English: • Increased amount of small protein fragments caused by break down of blood clots
Danish: • Øget mængde af små proteindele forårsaget af opløsning af størknet blod
English: • Pain where the injection is given
Danish: • Smerter, hvor injektionen bliver givet
English: • Distribution and use of the patient brochure and the need to ensure that the patient has read and understood the brochure
Danish: • Distribuering og brug af patientbrochurer og behovet for at sikre at patienten har læst og forstået denne
English: • Development of antibodies against factor XIII which have no influence on the effect of the drug.
Danish: • Udvikling af antistoffer mod faktor XIII, som ikke påvirker virkningen af lægemidlet.
English: Genotoxic potential or carcinogenicity has not been studied since rFXIII is an endogenous protein.
Danish: Genotoksisk potentiale eller karcinogenicitet er ikke undersøgt, da rFXIII er et endogent protein.
English: • How to recognise the potential side effects (thrombosis and embolism)
Danish: • Hvordan potentielle bivirkninger opdages (trombose og embolisme)
English: • Headache (most common side effect)
Danish: • Hovedpine (mest almindelige bivirkning)
English: After dilution proceed to step H.
Danish: Efter fortynding fortsættes til trin H.
English: If you are pregnant or breast-feeding, or if you think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.
Danish: Hvis du er gravid eller ammer, har mistanke om, at du er gravid, eller planlægger at blive gravid, skal du spørge din læge til råds, før du bruger dette lægemiddel.
English: Non-neutralising antibodies Fibrin D-dimer increased
Danish: Ikke-neutraliserende antistoffer Forhøjet fibrin D-dimer
English: Antibodies were transient in all patients.
Danish: Antistofferne var forbigående hos alle patienter.
English: The dose volume for small children can then be calculated by using the below formula:
Danish: Dosisvolumen for små børn kan derefter regnes ud ved at benytte følgende formel:
English: Pack size of 1.
Danish: Pakningsstørrelse á 1.
English: Side effects in children:
Danish: Bivirkninger hos børn:
English: The injections are given once a month (every 28 ± 2 days).
Danish: Injektionerne gives en gang om måneden (hver 28. dag ± 2 dage).
English: Frequency categories are defined according to the following convention: 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), not known (cannot be estimated from the available data).
Danish: Frekvenskategorier er defineret efter den følgende konvention: 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), ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: Contact your doctor if you have injected more NovoThirteen than you have been instructed.
Danish: Kontakt din læge, hvis du har injiceret mere NovoThirteen, end du har fået besked på.
English: However, based on the therapeutic need the use of NovoThirteen may be considered during pregnancy.
Danish: På baggrund af det terapeutiske behov kan anvendelse af NovoThirteen imidlertid overvejes under graviditet.
English: Follow the injection procedure as instructed by your doctor.
Danish: Følg injektionsproceduren efter din læges anvisninger.
English: Your doctor may adapt the dose if this is deemed necessary.
Danish: Din læge kan tilpasse dosis hvis det er nødvendigt.
English: The side effects observed in children are the same as also observed in adults but the side effects may be more common in children than in adults.
Danish: Bivirkninger der er blevet observeret hos børn, er de samme som hos voksne, men bivirkningerne kan være mere almindelige hos børn end hos voksne.
English: Do not use this medicine after the expiry date which is stated on the label and the outer carton after ‘EXP.'.
Danish: Brug ikke dette lægemiddel efter den udløbsdato, der står på pakningen efter 'EXP'.
English: Also, on-demand treatment is followed in a noninterventional post-authorisation safety study (NN1841-3868).
Danish: Behovsbehandling bliver også fulgt i et ikkeinterventions-, sikkerhedsstudie efter markedføring (NN1841-3868).
English: This dose adjustment should be based on FXIII activity levels.
Danish: Denne justering skal baseres på FXIII aktivitetsniveauer.
English: There are no human data on potential effects on fertility.
Danish: Der foreligger ingen data for mennesker om potentiel påvirkning af fertiliteten.
English: Incorrect storage of the product after reconstitution must be avoided as it may result in loss of sterility and in increased levels of non-proteolytically activated NovoThirteen.
Danish: Ukorrekt opbevaring af produktet efter rekonstitution skal undgås, da dette kan medføre tab af sterilitet og et øget niveau af ikke-proteolytisk aktiveret NovoThirteen.
English: • Indication of the product
Danish: • Produktets indikation
English: Increased levels of activated NovoThirteen may increase the risk of thrombosis.
Danish: Et øget niveau af aktiveret NovoThirteen kan øge risikoen for trombose.
English: For more information see section ‘NovoThirteen user instructions - Instructions of how to dilute the reconstituted NovoThirteen'.
Danish: For yderligere information se 'NovoThirteen Brugervejledning - Vejledning til fortynding af det opblandede NovoThirteen'.
English: 3 of the patients discontinued the study and returned to their previous treatment.
Danish: Tre af patienterne afbrød studiet og fortsatte deres tidligere behandling.
English: You should only use the prescribed dose calculated by your doctor from this formula considering that the usual dose and the concentration of NovoThirteen are different from those of the other products which contain factor XIII.
Danish: Du må kun bruge den ordinerede dosis, der er beregnet af din læge ud fra denne formel, og hvor det er taget i betragtning, at den sædvanlige dosis og koncentrationen af NovoThirteen er forskellig fra andre produkter der indeholder faktor XIII.