FrancophonIA/ELRC3.0 huggingface dataset:
English: Doctors should also consider other official guidance when choosing a dose and dosing schedule for ImmunoGam
Danish: Læger bør også tage andre officielle vejledninger i betragtning, når der vælges dosis og doseringsplan for ImmunoGam.
English: ImmunoGam is given as an injection into a muscle.
Danish: ImmunoGam gives som injektion i en muskel.
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for ImmunoGam.
Danish: Det forklarer, hvordan Udvalget for Humanmedicinske Lægemidler (CHMP) vurderede lægemidlet og nåede frem til sin udtalelse til fordel for udstedelse af en markedsføringstilladelse og til sine anbefalinger om anvendelsesbetingelserne for ImmunoGam.
English: For more information about treatment with ImmunoGam, read the Package Leaflet (also part of the EPAR).
Danish: De nærmere oplysninger om behandling med ImmunoGam fremgår af indlægssedlen (også en del af EPAR).
English: Finally, people at continuous risk of hepatitis B infection who did not show an immune response after vaccination may be given 500 IU (in adults) or 8 IU/kg (in children) every two months.
Danish: Personer, der er udsat for kontinuerlig risiko for hepatitis B-infektion, og som ikke har udvist en immunrespons efter vaccination, kan gives 500 IU (hos voksne) eller 8 IU/kg (hos børn) hver anden måned.
English: This may need to be repeated until the babies show an immune response against the virus after vaccination.
Danish: Dette gentages eventuelt, indtil den nyfødte udviser en immunrespons mod virusset efter vaccination.
English: ImmunoGam should not be used in people who may be hypersensitive (allergic) to the active substance, to any of the other ingredients or to human immunoglobulins, especially where they have deficiency (very low levels) of immunoglobulin A (IgA) and they have antibodies against IgA.
Danish: ImmunoGam må ikke anvendes til personer, som kan være hypersensitive (overfølsomme) over for det aktive stof, et eller flere af de øvrige indholdsstoffer eller over for humane immunglobuliner, særlig når de mangler (har meget lave niveauer af) immunglobulin A (IgA) og har antistoffer mod IgA.
English: The full EPAR for ImmunoGam can be found here.
Danish: Den fuldstændige EPAR for ImmunoGam her.
English: • people accidentally exposed to the virus who are not known to have been vaccinated fully;
Danish: • personer, som ved et uheld bliver udsat for smitte, og som ikke er fuldt vaccineret
English: The main measure of effectiveness was the number of people who remained free of hepatitis B infection.
Danish: Det primære effektmål var antallet af personer, som forblev frie for hepatitis B-infektion.
English: • people at continuous risk of hepatitis B infection who have not responded to vaccination.
Danish: • personer, der har en kontinuerlig risiko for infektion med hepatitis B, og som ikke har udvist immunrespons efter vaccination.
English: ImmunoGam protects against the hepatitis B virus by keeping the blood levels of human hepatitis B immunoglobulins high enough so that they can attach to the virus and stimulate the immune system to destroy it.
Danish: ImmunoGam beskytter mod hepatitis B-virus ved, at koncentrationen af humane hepatitis B-immunglobuliner i blodet holdes på et tilstrækkeligt højt niveau til, at de kan binde sig til virusset og stimulere immunsystemet til at ødelægge det.
English: The Committee for Medicinal Products for Human Use (CHMP) decided that ImmunoGam's benefits are greater than its risks and recommended that it be given marketing authorisation.
Danish: Udvalget for Humanmedicinske Lægemidler (CHMP) konkluderede, at fordelene ved ImmunoGam opvejer risiciene og anbefalede udstedelse af markedsføringstilladelse for ImmunoGam.
English: However, the following side effects are seen in between 1 and 10 patients in 1,000: headache, dizziness, nausea, arthralgia (joint pain), back pain, myalgia (muscle pain), fatigue (tiredness), induration (hardening at the injection site), malaise (feeling unwell), pain at injection site and pyrexia (fever).
Danish: Følgende bivirkninger er dog set hos mellem 1 og 10 patienter ud af 1.000: hovedpine, svimmelhed, kvalme, artralgi (ledsmerter), rygsmerter, myalgi
English: What is the risk associated with ImmunoGam?
Danish: Hvilken risiko er der forbundet med ImmunoGam?
English: The active substance in ImmunoGam, human hepatitis B immunoglobulin, is a purified antibody extracted from human blood.
Danish: Det aktive stof i ImmunoGam, humant hepatitis B-immunglobulin, er et renset antistof udvundet af humant blod.
English: ImmunoGam human hepatitis B immunoglobulin
Danish: ImmunoGam humant hepatitis B-immunglobulin
English: The results in adults also provided some supportive evidence to show that ImmunoGam protects against hepatitis B virus infection.
Danish: Resultaterne hos voksne viste også nogen understøttende evidens for, at ImmunoGam beskytter mod infektion med hepatitis B-virus.
English: Why has ImmunoGam been approved?
Danish: Hvorfor blev ImmunoGam godkendt?
English: Side effects with ImmunoGam are not common.
Danish: Der ses normalt ikke bivirkninger ved ImmunoGam.
English: It is highly recommended that all those receiving ImmunoGam should also be given a hepatitis B vaccine.
Danish: Det anbefales på det kraftigste, at personer, der får ImmunoGam, også gives en hepatitis B-vaccine.
English: What is ImmunoGam?
Danish: Hvad er ImmunoGam?
English: ImmunoGam is used to provide protection against the hepatitis B virus.
Danish: ImmunoGam anvendes til at yde beskyttelse mod hepatitis B-virus.
English: All those who received ImmunoGam were also given a hepatitis B vaccine.
Danish: Alle dem, der fík ImmunoGam, fik også en hepatitis B-vaccine.
English: ImmunoGam is a solution for injection that contains the active substance human hepatitis B immunoglobulin.
Danish: ImmunoGam er en opløsning til injektion, som indeholder det aktive stof humant hepatitis Bimmunglobolin.
English: • newborn babies whose mothers are carriers of the virus;
Danish: • nyfødte, hvor moderen er bærer af hepatitis B-virus
English: How has ImmunoGam been studied?
Danish: Hvordan blev ImmunoGam undersøgt?
English: What is ImmunoGam used for?
Danish: Hvad anvendes ImmunoGam til?
English: ImmunoGam was effective at protecting against hepatitis B virus infection.
Danish: ImmunoGam ydede effektiv beskyttelse mod infektion med hepatitis B-virus.
English: What benefit has ImmunoGam shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved ImmunoGam?
English: How does ImmunoGam work?
Danish: Hvordan virker ImmunoGam?
English: This means that, although there is insufficient evidence from clinical trials, the effectiveness of these herbal medicines is plausible and there is evidence that they have been used safely in this way for at least 30 years (including at least 15 years within the EU).
Danish: Det betyder, at selv om der ikke foreligger dokumentation fra kliniske undersøgelser, kan det antages, at disse plantelægemidler har en virkning, og der er dokumentation for, at de har været anvendt sikkert på denne måde i mindst 30 år (heraf mindst 15 år i EU).
English: EMA/HMPC/441263/2013
Danish: Diktammerianurt EMA/HMPC/441263/2013
English: In its assessment the HMPC took into account the well documented and longstanding use of dittany of Crete for these conditions.
Danish: I sin vurdering tog HMPC hensyn til den veldokumenterede og langvarige anvendelse af diktammerianurt til disse formål.
English: When used for skin problems the infusion may be used in those above the age of 12 years for up to two weeks; if symptoms last longer than this, advice should be sought from a qualified healthcare practitioner.
Danish: Mod hudproblemer kan udtrækket anvendes hos personer over 12 år i højst to uger; hvis symptomerne vedvarer, bør der søges lægehjælp.
English: Any applications for the licensing of medicines containing dittany of Crete herb have to be submitted to the national authorities responsible for medicinal products, which will assess the application for the herbal medicine and take into account the scientific conclusions of the HMPC.
Danish: Ansøgninger om godkendelse af lægemidler, der indeholder diktammerianurt, skal indsendes til de nationale lægemiddelmyndigheder, som vurderer ansøgningen om plantelægemidlet og tager hensyn til HMPC's videnskabelige konklusioner.
English: The HMPC conclusions are taken into account by EU Member States when evaluating applications for the licensing of herbal medicines containing dittany of Crete.
Danish: EU's medlemsstater tager hensyn til HMPC's konklusioner, når de vurderer ansøgninger om godkendelse af plantelægemidler, der indeholder diktammerianurt.
English: Dittany of Crete herb is the common name for the flowering above-ground (aerial) parts of Origanum dictamnus L. The plant is cultivated or gathered to obtain the above-ground parts for medicinal use.
Danish: Diktammerianurt er fællesnavnet for de overjordiske dele af Origanum dictamnus L. Planten dyrkes eller indsamles for at anvende dens overjordiske dele til medicinsk brug.
English: Herbal teas containing dittany of Crete should only be used in adults and should not be used for longer than a week for cough, or for longer than two weeks for stomach and gut problems, without seeking advice from a qualified healthcare practitioner.
Danish: Urtete indeholdende diktammerianurt bør kun anvendes af voksne, og højst anvendes en uge mod hoste og to uger mod mave-tarmproblemer, uden at der søges lægehjælp.
English: Detailed instruction on how to use dittany of Crete medicines and who can use them can be found in the package leaflet that comes with the medicine.
Danish: Detaljerede anvisninger for, hvordan lægemidler med diktammerianurt skal anvendes, og hvem der kan bruge dem, findes i indlægssedlen i pakningen.
English: The HMPC conclusions on the use of dittany of Crete herb medicines for cough, stomach, gut and skin problems are based on their ‘traditional use' in these conditions.
Danish: HMPC's konklusioner om anvendelsen af lægemidler indeholdende diktammerianurt ved hoste og mave-tarm- og hudproblemer bygger på lægemidlernes “traditionelle anvendelse” ved disse lidelser.
English: Further information on the risks associated with dittany of Crete herb medicines, including the appropriate precautions for their safe use, can be found in the monograph under the tab ‘All documents' on the Agency's website: ema.europa.eu/Find medicine/Herbal medicines for human use.
Danish: Yderligere oplysninger om risici forbundet med lægemidler, der indeholder diktammerianurt, herunder passende forholdsregler, som skal følges med henblik på sikker anvendelse, findes i monografien under fanebladet “All documents” på Det Europæiske Lægemiddelagenturs websted: ema.europa.eu/Find medicine/Herbal medicines for human use.
English: Further information on the HMPC assessment of dittany of Crete herb medicines, including details of the Committee's conclusions, can be found under the tab ‘All documents' on the Agency's website: ema.europa.eu/Find medicine/Herbal medicines for human use.
Danish: Yderligere oplysninger om HMPC's vurdering af lægemidler, der indeholder diktammerianurt, herunder detaljerede oplysninger om udvalgets konklusioner, findes under fanebladet “All documents” på det europæiske lægemiddelagenturs websted: ema.europa.eu/Find medicine/Herbal medicines for human use.
English: Information on the use and licensing of dittany of Crete herb medicines in EU Member States should be obtained from the relevant national authorities.
Danish: Oplysninger om europæisk anvendelse og godkendelse af lægemidler, der indeholder diktammerianurt, skal indhentes fra de relevante nationale myndigheder i EU's medlemsstater.
English: For detailed information on the studies assessed by the HMPC, see the HMPC assessment report.
Danish: Nærmere oplysninger om de undersøgelser / informationer, der indgår i HMPC´svurdering, findes i HMPC's vurderingsrapport.
English: This is a summary of the scientific conclusions reached by the Committee on Herbal Medicinal Products (HMPC) on the medicinal uses of dittany of Crete herb.
Danish: Dette er et sammendrag af Udvalget for Plantelægemidlers (HMPC) videnskabelige konklusioner om den medicinske anvendelse af diktammerianurt.
English: It also considered published experimental studies and reports which supported the plausibility of the use of dittany of Crete herb in the approved indications.
Danish: Udvalget tog desuden hensyn til offentliggjorte undersøgelser og rapporter, der støtter anvendelsen af diktammerianurt til de godkendte formål.
English: This summary is not intended to provide practical advice on how to use medicines containing dittany of Crete herb.
Danish: Dette sammendrag er ikke en praktisk vejledning i, hvordan plantelægemidler, der indeholder diktammerianurt, anvendes.
English: The HMPC concluded that, on the basis of its long-standing use, dittany of Crete herb can be used as a herbal tea for the relief of cough associated with cold and for mild disorders of the stomach and gut such as a sensation of fullness or digestive problems.
Danish: På baggrund af den mangeårige anvendelse, har HMPC konkluderet, at diktammerianurt kan anvendes som urtete til lindring af hoste i forbindelse med forkølelse samt ved milde mave-tarmlidelser såsom oppustethed eller fordøjelsesbesvær.
English: The infusion can also be used to soak a dressing and applied to the skin for minor skin inflammations and bruises.
Danish: Afkog kan desuden bruges til at væde en bandage, der lægges på huden ved lettere hudinflammation og knubs.
English: How are dittany of Crete herb medicines approved in the EU?
Danish: Hvordan godkendes lægemidler, der indeholder diktammerianurt, i EU?
English: Herbal medicines are usually available as comminuted herbal material that is used to make herbal teas or added to water to produce a liquid (infusion) to be applied to the skin.
Danish: Plantelægemidler fås sædvanligvis som findelt plantemateriale, der anvendes til urtete eller fremstilling af et vandigt afkog, der påføres huden.
English: For practical information about using dittany of Crete medicines, patients should read the package leaflet that comes with the medicine or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktiske oplysninger om anvendelsen af lægemidler med diktammerianurt, kan du læse indlægssedlen, der ligger i lægemiddelpakningen, eller kontakte din læge eller dit apotek.
English: For more information about treatment with dittany of Crete herb medicines, read the package leaflet that comes with the medicine or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med lægemidler, der indeholder diktammerianurt, kan du læse indlægssedlen, der ligger i lægemiddelpakningen, eller kontakte din læge eller dit apotek.
English: What evidence supports the use of dittany of Crete herb medicines?
Danish: Hvilken dokumentation underbygger den medicinske anvendelse af diktammerianurt?
English: What are the risks associated with dittany of Crete herb medicines?
Danish: Hvilke risici er der forbundet med lægemidler, der indeholder diktammerianurt?
English: Other information about dittany of Crete herb medicines
Danish: Andre oplysninger om lægemidler, der indeholder diktammerianurt
English: Preparations of the herb are obtained by comminuting (reducing into tiny pieces) the harvested material.
Danish: Dictammerianurt forarbejdes ved findeling af det høstede materiale.
English: What is dittany of Crete herb?
Danish: Hvad er diktammerianurt?
English: Committee on Herbal Medicinal Products (HMPC)
Danish: EMA/HMPC/441263/2013 Udvalget for Plantelægemidler (HMPC)
English: Dittany of Crete herb
Danish: Diktammerianurt
English: 2333 BE Leiden Netherlands
Danish: 2333 BE Leiden Holland
English: (frequency cannot be estimated from available data)
Danish: (kan ikke estimeres ud fra forhåndenværende data)
English: Date of first authorisation: 25 April 2008 Date of latest renewal: 19 February 2018
Danish: Dato for første markedsføringstilladelse: 25. april 2008 Dato for seneste fornyelse: 19. februar 2018
English: The powder will dissolve completely.
Danish: Pulveret vil opløses fuldstændigt.
English: The potential risk for humans is unknown.
Danish: Risikoen for mennesker er ukendt.
English: These findings showed reversibility over a follow-up period of 18 months.
Danish: Disse fund viste reversibilitet over en opfølgningsperiode på 18 måneder.
English: Mycamine is indicated for:
Danish: Mycamine er indiceret til:
English: In addition, only a small number of cases involved these species in the clinical trials.
Danish: Desuden var det kun nogle få tilfælde, der involverede disse arter i de kliniske studier.
English: More rapid infusions may result in more frequent histamine mediated reactions.
Danish: Hurtigere infusioner kan føre til hyppigere histaminmedierede reaktioner.
English: Experience with Mycamine in patients less than 2 years of age is limited.
Danish: Erfaring med Mycamine hos patienter under 2 år er begrænset.
English: ‡ Adjusted for neutropenic status; primary endpoint.
Danish: ‡ Tilpasset neutropene status; primært endpoint.
English: Volume (concentration) of reconstituted powder
Danish: Volumen (koncentration) af rekonstitueret pulver
English: Neutropenia persisted for a median of 13 days.
Danish: Neutropeni varede i gennemsnit 13 dage.
English: The volume of distribution at steady state (Vss) was approximately 18-19 litres.
Danish: Fordelingsvolumen ved steady state (Vss) var ca. 18-19 liter.
English: The lower limit of the 95% CI was above the predefined non-inferiority margin of -10%, proving non-inferiority.
Danish: Den nedre grænse for konfidensintervallet på 95 % lå over den prædefinerede non-inferioritetsmargin på -10 %, og viste derfor non-inferioritet.
English: In case of overdose, general supportive measures and symptomatic treatment should be administered.
Danish: I tilfælde af overdosering bør der sættes ind med generelle støtteforanstaltninger og symptomatisk behandling.
English: >R (Resistant)
Danish: >R (Resistent)
English: These data indicate that elimination of micafungin is primarily non-renal.
Danish: Disse data indikerer, at elimination af micafungin primært er ikke-renal.
English: DO NOT SHAKE.
Danish: RYST IKKE.
English: Your doctor may decide to adjust the dose of these medicines.
Danish: Deres læge vil muligvis justere dosis af disse lægemidler.
English: Body weight > 40 kg Body weight ≤ 40 kg
Danish: Legemsvægt > 40 kg Legemsvægt ≤ 40 kg
English: Your doctor will determine how much Mycamine you will receive each day.
Danish: Lægen vil beregne, hvor meget Mycamine De skal have hver dag.
English: However, the difference was not significant and whether it translates into a relevant clinical difference is unknown.
Danish: Imidlertid var forskellen ikke signifikant, og det er uvist, hvorvidt det svarer til en relevant klinisk forskel.
English: The drug is rapidly distributed into tissues.
Danish: Medicinen fordeles hurtigt i vævene.
English: Mycamine may cause the following other side effects:
Danish: Mycamine kan give følgende øvrige bivirkninger:
English: Unchanged micafungin is the principal circulating compound in systemic circulation.
Danish: Uforandret micafungin er det vigtigste cirkulationsstof i systemisk cirkulation.
English: Only a trained healthcare professional who has read the complete directions properly can prepare this medicine for use.
Danish: Kun uddannet sundhedspersonale, som har læst hele vejledningen grundigt, må tilberede dette lægemiddel.
English: Symptoms such as rash and rigors have been reported in clinical studies.
Danish: Symptomer såsom udslæt og rigor er indberettet i kliniske studier.
English: The vial is wrapped with an UV-protective film.
Danish: Hætteglasset er pakket i UV-beskyttende film.
English: Exposure to these metabolites is low and metabolites do not contribute to the overall efficacy of micafungin.
Danish: Eksponering for disse metabolitter er lav, og metabolitterne bidrager ikke til den samlede effekt af micafungin.
English: % Difference [95% CI]
Danish: % Afvigelse [95% KI]
English: Mycamine must be prepared and given to you by a doctor or another healthcare professional.
Danish: Mycamine skal tilberedes og indgives til Dem af en læge eller andet sundhedspersonale.
English: The clinical relevance of this finding is not known.
Danish: Den kliniske relevans af denne observation er ikke kendt.
English: This means there is insufficient evidence to indicate whether the wild-type population of these pathogens can be considered susceptible to micafungin.
Danish: Det betyder, at der ikke er tilstrækkelig evidens til at indikere, hvorvidt vildtype-populationen af disse patogener kan anses for at være følsomme for micafungin.
English: Other Candida spp.
Danish: Andre Candida spp.
English: From a microbiological point of view, the reconstituted and diluted solutions should be used immediately.
Danish: Set fra et mikrobiologisk synspunkt bør de rekonstituerede og fortyndede opløsninger anvendes straks.
English: There is no evidence of systemic accumulation with repeated administration and steady-state is generally reached within 4 to 5 days.
Danish: Ved gentagen indgift ses ingen tegn på systemisk akkumulering, og steady state nås sædvanligvis inden for 4-5 dage.
English: Mycamine with food and drink
Danish: Brug af Mycamine sammen med mad og drikke
English: Non-inferiority was proven for adult patients, and similar findings were demonstrated for the paediatric subpopulations (including neonates and premature infants).
Danish: Non-inferioritet blev påvist hos voksne patienter, og lignende resultater sås hos de pædiatriske undergrupper (herunder nyfødte og præmature spædbørn).
English: This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodiumfree'.
Danish: Dette lægemiddel indeholder mindre end 1 mmol natrium (23 mg) pr. dosis, det vil sige i det væsentlige ”natriumfri”.
English: Few patients (1.1%; 0.4% serious) discontinued treatment due to a hepatic event.
Danish: Få patienter (1,1 %; 0,4 % alvorlige) afbrød behandlingen pga. en hepatisk bivirkning.
English: Your doctor has prescribed Mycamine for you in the following circumstances when there are no other suitable antifungal treatments available (see section 2):
Danish: Deres læge har ordineret Mycamine til Dem under følgende omstændigheder, hvor der ikke findes andre hensigtsmæssige tilgængelige svampemidler (se punkt 2):
English: ¶ Clinical efficacy was also observed (< 5 patients) in the following Candida species: C. guilliermondii, C. famata, C. lusitaniae, C. utilis, C. inconspicua and C. dubliniensis.
Danish: ¶ Klinisk effekt blev også observeret (< 5 patienter) hos følgende Candida-arter: C. guilliermondii, C. famata, C. lusitaniae, C. utilis, C. inconspicua og C. dubliniensis.
English: Based on clinical trial experience, overall 32.2% of the patients experienced adverse drug reactions.
Danish: Baseret på erfaring fra kliniske studier oplevede i alt 32,2 % af patienterne bivirkninger.
English: At the recommended therapeutic dosage of Mycamine, these ratios are achievable for the wild-type distribution of Candida spp.
Danish: Ved den anbefalede terapeutiske dosis af Mycamine er disse ratioer opnåelige for vildtype-fordelingen af Candida spp.
English: There is no experience with overdoses of micafungin.
Danish: Der er ingen erfaring med overdosering af micafungin.
English: The exposure levels at which these effects did not occur (NOAEL) were in the same range as the clinical exposure or lower.
Danish: Eksponeringsniveauer, hvor disse bivirkninger ikke forekommer (NOAEL), lå i samme område som ved klinisk eksponering eller lavere.
English: As for all antimicrobial agents, cases of reduced susceptibility and resistance have been reported and cross-resistance with other echinocandins cannot be excluded.
Danish: Som med alle antimikrobielle midler er der indberettet tilfælde af reduceret følsomhed, og resistens og krydsresistens med andre echinocandiner kan ikke udelukkes.