natgillin/translations-raw huggingface dataset:
• patienter, der har været i hæmodialyse (en blodrensningsteknik, der anvendes på personer med nyreproblemer).
• patients who have had haemodialysis (a blood clearance technique used in people with kidney problems).
Personer, der ved et uheld bliver udsat for virusset, skal have mindst 500 internationale enheder (IU) snarest muligt og helst inden for 24 til 72 timer efter at være blevet udsat for virusset.
People accidentally exposed to the virus should receive at least 500 international units (IU) as soon as possible and preferably within 24 to 72 hours of exposure.
Patienter i hæmodialyse bør gives 8 til 12 IU pr. kg legemsvægt op til et maksimum på 500 IU hver anden måned.
Haemodialysed patients should received 8 to 12 IU per kilogram body weight up to a maximum of 500 IU, every two months.
ImmunoGam yder "passiv" beskyttelse.
ImmunoGam provides ‘passive' protection.
Læger bør også tage andre officielle vejledninger i betragtning, når der vælges dosis og doseringsplan for ImmunoGam.
Doctors should also consider other official guidance when choosing a dose and dosing schedule for ImmunoGam
ImmunoGam gives som injektion i en muskel.
ImmunoGam is given as an injection into a muscle.
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.
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.
De nærmere oplysninger om behandling med ImmunoGam fremgår af indlægssedlen (også en del af EPAR).
For more information about treatment with ImmunoGam, read the Package Leaflet (also part of the EPAR).
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.
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.
Dette gentages eventuelt, indtil den nyfødte udviser en immunrespons mod virusset efter vaccination.
This may need to be repeated until the babies show an immune response against the virus after vaccination.
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.
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.
Den fuldstændige EPAR for ImmunoGam her.
The full EPAR for ImmunoGam can be found here.
• personer, som ved et uheld bliver udsat for smitte, og som ikke er fuldt vaccineret
• people accidentally exposed to the virus who are not known to have been vaccinated fully;
Det primære effektmål var antallet af personer, som forblev frie for hepatitis B-infektion.
The main measure of effectiveness was the number of people who remained free of hepatitis B infection.
• personer, der har en kontinuerlig risiko for infektion med hepatitis B, og som ikke har udvist immunrespons efter vaccination.
• people at continuous risk of hepatitis B infection who have not responded to vaccination.
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.
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.
Udvalget for Humanmedicinske Lægemidler (CHMP) konkluderede, at fordelene ved ImmunoGam opvejer risiciene og anbefalede udstedelse af markedsføringstilladelse for ImmunoGam.
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.
Følgende bivirkninger er dog set hos mellem 1 og 10 patienter ud af 1.000: hovedpine, svimmelhed, kvalme, artralgi (ledsmerter), rygsmerter, myalgi
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).
Hvilken risiko er der forbundet med ImmunoGam?
What is the risk associated with ImmunoGam?
Det aktive stof i ImmunoGam, humant hepatitis B-immunglobulin, er et renset antistof udvundet af humant blod.
The active substance in ImmunoGam, human hepatitis B immunoglobulin, is a purified antibody extracted from human blood.
ImmunoGam humant hepatitis B-immunglobulin
ImmunoGam human hepatitis B immunoglobulin
Resultaterne hos voksne viste også nogen understøttende evidens for, at ImmunoGam beskytter mod infektion med hepatitis B-virus.
The results in adults also provided some supportive evidence to show that ImmunoGam protects against hepatitis B virus infection.
Hvorfor blev ImmunoGam godkendt?
Why has ImmunoGam been approved?
Der ses normalt ikke bivirkninger ved ImmunoGam.
Side effects with ImmunoGam are not common.
Det anbefales på det kraftigste, at personer, der får ImmunoGam, også gives en hepatitis B-vaccine.
It is highly recommended that all those receiving ImmunoGam should also be given a hepatitis B vaccine.
Hvad er ImmunoGam?
What is ImmunoGam?
ImmunoGam anvendes til at yde beskyttelse mod hepatitis B-virus.
ImmunoGam is used to provide protection against the hepatitis B virus.
Alle dem, der fík ImmunoGam, fik også en hepatitis B-vaccine.
All those who received ImmunoGam were also given a hepatitis B vaccine.
ImmunoGam er en opløsning til injektion, som indeholder det aktive stof humant hepatitis Bimmunglobolin.
ImmunoGam is a solution for injection that contains the active substance human hepatitis B immunoglobulin.
• nyfødte, hvor moderen er bærer af hepatitis B-virus
• newborn babies whose mothers are carriers of the virus;
Hvordan blev ImmunoGam undersøgt?
How has ImmunoGam been studied?
Hvad anvendes ImmunoGam til?
What is ImmunoGam used for?
ImmunoGam ydede effektiv beskyttelse mod infektion med hepatitis B-virus.
ImmunoGam was effective at protecting against hepatitis B virus infection.
Hvilken fordel viser undersøgelserne, at der er ved ImmunoGam?
What benefit has ImmunoGam shown during the studies?
Hvordan virker ImmunoGam?
How does ImmunoGam work?
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).
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).
Diktammerianurt EMA/HMPC/441263/2013
EMA/HMPC/441263/2013
I sin vurdering tog HMPC hensyn til den veldokumenterede og langvarige anvendelse af diktammerianurt til disse formål.
In its assessment the HMPC took into account the well documented and longstanding use of dittany of Crete for these conditions.
Mod hudproblemer kan udtrækket anvendes hos personer over 12 år i højst to uger; hvis symptomerne vedvarer, bør der søges lægehjælp.
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.
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.
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.
EU's medlemsstater tager hensyn til HMPC's konklusioner, når de vurderer ansøgninger om godkendelse af plantelægemidler, der indeholder diktammerianurt.
The HMPC conclusions are taken into account by EU Member States when evaluating applications for the licensing of herbal medicines containing dittany of Crete.
Diktammerianurt er fællesnavnet for de overjordiske dele af Origanum dictamnus L. Planten dyrkes eller indsamles for at anvende dens overjordiske dele til medicinsk brug.
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.
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.
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.
Detaljerede anvisninger for, hvordan lægemidler med diktammerianurt skal anvendes, og hvem der kan bruge dem, findes i indlægssedlen i pakningen.
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.
HMPC's konklusioner om anvendelsen af lægemidler indeholdende diktammerianurt ved hoste og mave-tarm- og hudproblemer bygger på lægemidlernes “traditionelle anvendelse” ved disse lidelser.
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.
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.
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.
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.
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.
Oplysninger om europæisk anvendelse og godkendelse af lægemidler, der indeholder diktammerianurt, skal indhentes fra de relevante nationale myndigheder i EU's medlemsstater.
Information on the use and licensing of dittany of Crete herb medicines in EU Member States should be obtained from the relevant national authorities.
Nærmere oplysninger om de undersøgelser / informationer, der indgår i HMPC´svurdering, findes i HMPC's vurderingsrapport.
For detailed information on the studies assessed by the HMPC, see the HMPC assessment report.
Dette er et sammendrag af Udvalget for Plantelægemidlers (HMPC) videnskabelige konklusioner om den medicinske anvendelse af diktammerianurt.
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.
Udvalget tog desuden hensyn til offentliggjorte undersøgelser og rapporter, der støtter anvendelsen af diktammerianurt til de godkendte formål.
It also considered published experimental studies and reports which supported the plausibility of the use of dittany of Crete herb in the approved indications.
Dette sammendrag er ikke en praktisk vejledning i, hvordan plantelægemidler, der indeholder diktammerianurt, anvendes.
This summary is not intended to provide practical advice on how to use medicines containing dittany of Crete herb.
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.
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.
Afkog kan desuden bruges til at væde en bandage, der lægges på huden ved lettere hudinflammation og knubs.
The infusion can also be used to soak a dressing and applied to the skin for minor skin inflammations and bruises.
Hvordan godkendes lægemidler, der indeholder diktammerianurt, i EU?
How are dittany of Crete herb medicines approved in the EU?
Plantelægemidler fås sædvanligvis som findelt plantemateriale, der anvendes til urtete eller fremstilling af et vandigt afkog, der påføres huden.
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.
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.
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.
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.
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.
Hvilken dokumentation underbygger den medicinske anvendelse af diktammerianurt?
What evidence supports the use of dittany of Crete herb medicines?
Hvilke risici er der forbundet med lægemidler, der indeholder diktammerianurt?
What are the risks associated with dittany of Crete herb medicines?
Andre oplysninger om lægemidler, der indeholder diktammerianurt
Other information about dittany of Crete herb medicines
Dictammerianurt forarbejdes ved findeling af det høstede materiale.
Preparations of the herb are obtained by comminuting (reducing into tiny pieces) the harvested material.
Hvad er diktammerianurt?
What is dittany of Crete herb?
EMA/HMPC/441263/2013 Udvalget for Plantelægemidler (HMPC)
Committee on Herbal Medicinal Products (HMPC)
Diktammerianurt
Dittany of Crete herb
(kan ikke estimeres ud fra forhåndenværende data)
(frequency cannot be estimated from available data)
Dato for første markedsføringstilladelse: 25. april 2008 Dato for seneste fornyelse: 19. februar 2018
Date of first authorisation: 25 April 2008 Date of latest renewal: 19 February 2018
Pulveret vil opløses fuldstændigt.
The powder will dissolve completely.
Risikoen for mennesker er ukendt.
The potential risk for humans is unknown.
Disse fund viste reversibilitet over en opfølgningsperiode på 18 måneder.
These findings showed reversibility over a follow-up period of 18 months.
Mycamine er indiceret til:
Mycamine is indicated for:
Desuden var det kun nogle få tilfælde, der involverede disse arter i de kliniske studier.
In addition, only a small number of cases involved these species in the clinical trials.
Hurtigere infusioner kan føre til hyppigere histaminmedierede reaktioner.
More rapid infusions may result in more frequent histamine mediated reactions.
Erfaring med Mycamine hos patienter under 2 år er begrænset.
Experience with Mycamine in patients less than 2 years of age is limited.
‡ Tilpasset neutropene status; primært endpoint.
‡ Adjusted for neutropenic status; primary endpoint.
Volumen (koncentration) af rekonstitueret pulver
Volume (concentration) of reconstituted powder
Neutropeni varede i gennemsnit 13 dage.
Neutropenia persisted for a median of 13 days.
Fordelingsvolumen ved steady state (Vss) var ca. 18-19 liter.
The volume of distribution at steady state (Vss) was approximately 18-19 litres.
Den nedre grænse for konfidensintervallet på 95 % lå over den prædefinerede non-inferioritetsmargin på -10 %, og viste derfor non-inferioritet.
The lower limit of the 95% CI was above the predefined non-inferiority margin of -10%, proving non-inferiority.
I tilfælde af overdosering bør der sættes ind med generelle støtteforanstaltninger og symptomatisk behandling.
In case of overdose, general supportive measures and symptomatic treatment should be administered.
>R (Resistent)
>R (Resistant)
Disse data indikerer, at elimination af micafungin primært er ikke-renal.
These data indicate that elimination of micafungin is primarily non-renal.
RYST IKKE.
DO NOT SHAKE.
Deres læge vil muligvis justere dosis af disse lægemidler.
Your doctor may decide to adjust the dose of these medicines.
Legemsvægt > 40 kg Legemsvægt ≤ 40 kg
Body weight > 40 kg Body weight ≤ 40 kg
Lægen vil beregne, hvor meget Mycamine De skal have hver dag.
Your doctor will determine how much Mycamine you will receive each day.
Imidlertid var forskellen ikke signifikant, og det er uvist, hvorvidt det svarer til en relevant klinisk forskel.
However, the difference was not significant and whether it translates into a relevant clinical difference is unknown.
Medicinen fordeles hurtigt i vævene.
The drug is rapidly distributed into tissues.
Mycamine kan give følgende øvrige bivirkninger:
Mycamine may cause the following other side effects:
Uforandret micafungin er det vigtigste cirkulationsstof i systemisk cirkulation.
Unchanged micafungin is the principal circulating compound in systemic circulation.
Kun uddannet sundhedspersonale, som har læst hele vejledningen grundigt, må tilberede dette lægemiddel.
Only a trained healthcare professional who has read the complete directions properly can prepare this medicine for use.
Symptomer såsom udslæt og rigor er indberettet i kliniske studier.
Symptoms such as rash and rigors have been reported in clinical studies.
Hætteglasset er pakket i UV-beskyttende film.
The vial is wrapped with an UV-protective film.
Eksponering for disse metabolitter er lav, og metabolitterne bidrager ikke til den samlede effekt af micafungin.
Exposure to these metabolites is low and metabolites do not contribute to the overall efficacy of micafungin.
% Afvigelse [95% KI]
% Difference [95% CI]
Mycamine skal tilberedes og indgives til Dem af en læge eller andet sundhedspersonale.
Mycamine must be prepared and given to you by a doctor or another healthcare professional.
Den kliniske relevans af denne observation er ikke kendt.
The clinical relevance of this finding is not known.
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.
This means there is insufficient evidence to indicate whether the wild-type population of these pathogens can be considered susceptible to micafungin.
Andre Candida spp.
Other Candida spp.
Set fra et mikrobiologisk synspunkt bør de rekonstituerede og fortyndede opløsninger anvendes straks.
From a microbiological point of view, the reconstituted and diluted solutions should be used immediately.
Ved gentagen indgift ses ingen tegn på systemisk akkumulering, og steady state nås sædvanligvis inden for 4-5 dage.
There is no evidence of systemic accumulation with repeated administration and steady-state is generally reached within 4 to 5 days.
Brug af Mycamine sammen med mad og drikke
Mycamine with food and drink
Non-inferioritet blev påvist hos voksne patienter, og lignende resultater sås hos de pædiatriske undergrupper (herunder nyfødte og præmature spædbørn).
Non-inferiority was proven for adult patients, and similar findings were demonstrated for the paediatric subpopulations (including neonates and premature infants).
Dette lægemiddel indeholder mindre end 1 mmol natrium (23 mg) pr. dosis, det vil sige i det væsentlige ”natriumfri”.
This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodiumfree'.
Få patienter (1,1 %; 0,4 % alvorlige) afbrød behandlingen pga. en hepatisk bivirkning.
Few patients (1.1%; 0.4% serious) discontinued treatment due to a hepatic event.
Deres læge har ordineret Mycamine til Dem under følgende omstændigheder, hvor der ikke findes andre hensigtsmæssige tilgængelige svampemidler (se punkt 2):
Your doctor has prescribed Mycamine for you in the following circumstances when there are no other suitable antifungal treatments available (see section 2):
¶ Klinisk effekt blev også observeret (< 5 patienter) hos følgende Candida-arter: C. guilliermondii, C. famata, C. lusitaniae, C. utilis, C. inconspicua og C. dubliniensis.
¶ 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.
Baseret på erfaring fra kliniske studier oplevede i alt 32,2 % af patienterne bivirkninger.
Based on clinical trial experience, overall 32.2% of the patients experienced adverse drug reactions.
Ved den anbefalede terapeutiske dosis af Mycamine er disse ratioer opnåelige for vildtype-fordelingen af Candida spp.
At the recommended therapeutic dosage of Mycamine, these ratios are achievable for the wild-type distribution of Candida spp.
Der er ingen erfaring med overdosering af micafungin.
There is no experience with overdoses of micafungin.
Eksponeringsniveauer, hvor disse bivirkninger ikke forekommer (NOAEL), lå i samme område som ved klinisk eksponering eller lavere.
The exposure levels at which these effects did not occur (NOAEL) were in the same range as the clinical exposure or lower.
Som med alle antimikrobielle midler er der indberettet tilfælde af reduceret følsomhed, og resistens og krydsresistens med andre echinocandiner kan ikke udelukkes.
As for all antimicrobial agents, cases of reduced susceptibility and resistance have been reported and cross-resistance with other echinocandins cannot be excluded.
Brug ikke Mycamine efter den udløbsdato, der står på hætteglasset og på pakningen.
Do not use Mycamine after the expiry date which is stated on the vial and on the carton.
Bindingen til albumin er uafhængig af koncentrationen af micafungin (10-100 μg/ml).
Binding to albumin is independent of micafungin concentration (10-100 µg/ml).
Der foreligger ikke data om brugen af micafungin hos gravide kvinder.
There are no data from the use of micafungin in pregnant women.
Til trods for at koncentratet vil skumme, skal man forsøge at minimere mængden af skum mest muligt.
Although the concentrate will foam, every effort should be made to minimise the amount of foam generated.