natgillin/translations-raw huggingface dataset:
Kvinder, der begyndte at bruge antikonceptiva inden 20-års alderen, havde desuden større risiko for at få brystcancer end de, der begyndte senere: RR = 1,22 (95 % sikkerhedsinterval 1,17; 1,26) (Lancet 
Moreover, women who started OC use before age 20 had a higher risk of breast cancer than those starting later, RR = 1.22 (95 % confidence interval 1.17-1.26; Lancet 1996).
Dette er en vigtig faktor ved ordination af et oralt antikonceptivum og kan udelukke kombinerede orale antikonceptiva med EE/DRSP som førstevalgs antikonceptiva i klinisk praksis. 
This is an important factor when prescribing an oral contraceptive and may preclude EE/DRSP-COCs to be regarded as a first choice for contraception, in clinical practice.
I januar 2012 foretog arbejdsgruppen vedrørende lægemiddelovervågning (PhVWP) således en sikkerhedsgennemgang, der bekræftede, at orale antikonceptiva indeholdende DRSP medfører større risiko for VTE end orale antikonceptiva indeholdende levonorgestrel, og at risikoen muligvis er den samme som med orale antikonceptiva indeholdende desogestrel/gestoden. 
The most recent review by the Pharmacovigilance Working Party (PhVWP) concluded in January 2012, confirmed that DRSP-containing OCs are associated with a higher VTE risk than levonorgestrel-containing COCs and that the risk may be similar to that for desogestrel/gestodenecontaining COCs.
De risikominimeringsforanstaltninger, der er foreslået af indehaveren af markedsføringstilladelsen, blev af CHMP ikke anset for tilstrækkelige til at sikre risikofri og effektiv anvendelse af EE/DRSP i den særlige kliniske situation, som ansøgningen vedrørte. 
The CHMP considered the MAH proposed measures for risk minimisation not sufficient to ensure the safe and effective use of EE/DRSP in the specific applied clinical situation.
Indehaveren af markedsføringstilladelsen forelagde et program, der skulle sikre risikofri anvendelse af kombinerede perorale antikonceptiva med EE/DRSP og begrænse eventuel ikke-godkendt anvendelse efter at den ansøgte indikation er godkendt. 
The MAH submitted a risk minimisation program to ensure the safe use of EE/DRSP COCs and to limit possible off-label use following authorisation of the applied indication.
Indehaveren af markedsføringstilladelsen har endvidere ikke kunnet påvise, at patienterne vil blive sat over på andre acnemidler, når behovet for oral antikonception ophører. 
Furthermore the MAH failed to show that once the need for oral contraception seizes to exist, the patients will be switched to other acne treatments.
Den overordnede sikkerhedsprofil af orale antikonceptiva af typen EE/DRSP er velkendt og er forbundet med alvorlige bivirkninger (VTE og brystcancer). 
Overall, the safety profile of EE/DRSP oral contraceptives is known and associated with serious adverse events (i.e. VTE and breast cancer).
CHMP vurderede de af indehaveren af markedsføringstilladelsen påtænkte foranstaltninger, der skulle sikre risikofri anvendelse af perorale kontraceptiva med EE/DRSP og begrænse eventuel ikke godkendt anvendelse, efter at den ansøgte indikation er godkendt. 
The CHMP considered the MAH proposed measures for risk minimisation to ensure the safe use of EE/DRSP COCs and to limit possible off-label use following authorisation of the applied indication.
På ordinationstidspunktet vil patienten have behov for både acnebehandling og oral antikonception. 
In addition, the dual need for treatment of acne while the patient will also need oral contraception will exist at time of prescribing.
I betragtning af alt det ovennævnte og den store udbredelse af acne blandt unge kvinder var der i udvalget bekymring for, at en gavnlig effekt af EE/DRSP kan mindske patientens motivation til at ophøre med indtagelsen ved ophør af behovet for antikonception. 
Considering all the above and the fact that acne is a very common condition in young women, the Committee raised concerns that a beneficial effect noted by the patient from use of EE/DRSP would reduce the motivation to stop the intake when the need for contraception ceases and, therefore, it would not be possible to ensure that the use of the medicinal product would be limited to the treatment of moderate acne vulgaris only in women seeking oral contraception.
Dette medførte betænkelighed, da risikoen for venøs tromboembolisme for orale antikonceptiva indeholdende drospirenon er cirka dobbelt så stor som for orale antikonceptiva indeholdende levonorgestrel. 
This is of concern as the risk of venous thromboembolism for drospirenone-containing OCs is higher (approximately 2-fold) than for levonorgestrel-containing OCs.
Derudover planlagdes to undersøgelser af lægemiddelanvendelse til overvågning af oplysningsprogrammets virkning gennem registrering af ordinationspraksis for kombinerede perorale antikonceptiva med EE/DRSP i Europa. 
In addition, and in order to monitor the effectiveness of the educational program with the consequent monitoring of the EE/DRSP-COCs prescribing practices in Europe, two drug utilization studies were proposed.
Heri skulle der lægges vægt på benefit/risk-forholdet for anvendelse af EE/DRSP hos målpopulationen, undgåelse af ikke-godkendt brug og information af patienterne om, at behandling af moderat acne med EE/DRSP udelukkende er til patienter med behov for hormonel antikonception. 
General tools (e.g. lectures, conferences, symposia) targeting health care providers were proposed as educational material for prescribers by emphasising on the benefit/risk of EE/DRSP use in targeted population and discourage off-label use as well as to highlight to the patients that treatment of moderate acne with EE/DRSP is limited to patients who indeed require hormonal contraception.
For aldersfordelingen ved førstegangsanvendelse fremgik det endvidere, at brystcancerrisikoen var større hos kvinder, der var begyndt at bruge orale antikonceptiva inden 20-års alderen, end for dem, der begyndte senere, med RR = 1,22 (95 % sikkerhedsinterval 1,17; 1,26) (Lancet 1996). 
Moreover, when data were analysed by age at first use, women who started OC use before age 20 had a higher risk of breast cancer than those starting later, RR = 1.22 (95 % confidence interval 1.17-1.26; Lancet 1996).
Baggrunden var navnlig, at kombinerede antikonceptiva med drospirenon (DRSP-COC) medfører større risiko for venøse tromboemboliske hændelser (VTE) end kombinerede antikonceptiva med levonorgestrel (LNG-COC). 
a) the known greater risk of venous thromboembolic events (VTE) for DRSP-COCs in comparison with levonorgestrel (LNG)-COCs;
Den hidtil største metaanalyse af brystcancerrisiko omfattede 53 297 kvinder med brystkræft og 100 239 kontrolpersoner. 
With regard to breast cancer risk, the largest meta-analysis to date, including 53297 women with breast cancer and 100239 controls, showed that current use of combined OCs was associated with a relative risk (RR) of 1.24 (95 % confidence interval 1.15-1.33).
CHMP blev anmodet om at afgive en udtalelse om, hvorvidt det overordnede benefit/risk-forhold for Ethinylestradiol-Drospirenone til den ansøgte indikation anses for acceptabelt. 
The CHMP was requested to give its opinion on whether the overall risk-benefit profile for Ethinylestradiol-Drospirenone 24+4 in the proposed indication was considered acceptable, particularly in light of the known greater risk of venous thromboembolic events (VTE) for DRSP-COCs in comparison with levonorgestrel (LNG)COCs, and initiated the procedure in July 2011.
a) den kendte større risiko for venøse tromboemboliske hændelser med kombinerede orale antikonceptiva indeholdende DRSP end for tilsvarende præparater indeholdende levonorgestrel b) den potentielle anvendelse af produktet til kvinder, der ikke er tilhører målpopulationen. 
b) the potential use of the product for women who are not comprised in the target population.
¾ Den specifikke godkendte indikation. 
¾ The specific indication approved.
Betingelser eller begrænsninger med hensyn til en sikker og effektiv anvendelse af lægemidlet pålagt 
CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT TO BE IMPLEMENTED BY THE MEMBER STATES
¾ Manglen på kliniske data til at understøtte kombination med theophyllin og at en sådan kombination derfor ikke anbefales. 
¾ The lack of clinical data to support the combination with theophylline and that such combination is not recommended.
• Indehaveren af markedsføringstilladelsen (MAH) skal sikre, at alle sundhedsprofessionelle, der forventes at ordinere Daliresp, er forsynet med en uddannelsespakke ved lanceringen. 
• The Marketing Authorisation Holder (MAH) should ensure that, at launch, all Healthcare Professionals who are expected to prescribe Daliresp are provided with an Educational pack.
¾ Nødvendigheden af, at informere patienter om risici ved Daliresp og forholdsregler for sikker brug. 
¾ The need to inform patients about the risks of Daliresp and the precautions for safe use.
¾ Den potentielle risiko for maligne tumorer og den manglende erfaring hos patienter med en tidligere kræftsygdom. 
¾ The potential risk of malignant tumours and the lack of experience in patients with past history of cancer.
Dalirespbehandling bør ikke påbegyndes eller bør stoppes hos patienter med kræft (bortset fra basalcellekarcinom). 
Daliresp should not be initiated or should be stopped in patients with cancers (except basal cell carcinoma).
¾ At øget eksponering kan forekomme i visse befolkningsgrupper og øge risikoen for vedvarende intolerans: o Særlige populationer, der har forøget PDE4 hæmning såsom negroide, ikke-rygende kvinder o Patienter i samtidig behandling med en CYP1A2-hæmmer (såsom fluvoxamin) eller samtidigt med CYP3A4-/1A2-hæmmere (såsom enoxacin og cimetidin) 
¾ That increased exposure might occur in certain populations and increase the risk of persistent intolerability: o Special populations who have increased PDE4 inhibition such as black non smoking females o Patients concomitantly treated with CYP1A2 inhibitors (such as fluvoxamine) or dual CYP3A4/1A2 inhibitors (such as enoxacin and cimetidine)
¾ Den potentielle kardielle risiko: Daliresp er ikke undersøgt hos patienter med kongestiv hjerteinsufficiens (NYHA grad 3 og 4), og derfor kan det ikke anbefales til denne population. 
¾ The potential cardiac risk: Daliresp has not been studied in patients in congestive heart failure (NYHA grade 3 and 4); hence, it is not recommended in this population.
Daliresp er kontraindiceret til patienter med moderat eller svær nedsat leverfunktion (Child Pugh B eller C). 
Daliresp is contraindicated in patients with moderate or severe liver impairment (Child Pugh B or C).
Samt den omstændighed, at Daliresp hverken er indiceret til behandling af andre KOL-patienter end dem, der er beskrevet i den godkendte indikation, eller er til brug til patienter med astma eller alfa-1-antitrypsinmangel. 
The fact that Daliresp is not indicated for the treatment of COPD patients other than those covered by the approved indication, nor for use in patients with asthma or alpha 1 anti trypsine deficiency.
¾ Risikoen for vægttab hos undervægtige patienter og behovet for at kontrollere kropsvægt ved hvert besøg, og at behandlingen skal stoppes i tilfælde af et uforklarligt og klinisk bekymrende vægttab. 
¾ The risk of weight decrease in underweight patients and the need to monitor the body weight at each visit and to stop the treatment in the event of an unexplained and clinically concerning weight decrease.
¾ De begrænsede eller manglende data hos patienter med nedsat leverfunktion. 
¾ The limited or missing information in patients with liver impairment.
¾ Risikoen for psykiske forstyrrelser, såsom søvnløshed, angst eller depression hos patienter, der tager Daliresp og den potentielle risiko for selvmord. 
¾ The risk of psychiatric disorders such as insomnia, anxiety, depression in patients receiving Daliresp and the potential risk of suicide.
¾ Den potentielle risiko for infektioner: Dalirespbehandling bør ikke påbegyndes eller skal stoppes hos patienter med svære akutte smitsomme sygdomme. 
¾ The potential risk of infections: Daliresp should not be initiated, or treatment should be stopped, in patients with severe acute infectious diseases.
• Kopier af patientkortet, der skal udleveres til patienten ved udskrivning af Daliresp 
• Copies of the patient card to be given to patients before they receive Daliresp
Daliresp anbefales ikke til patienter med en tidligere depression og heraf afledte selvmordstanker eller -adfærd. 
Daliresp is not recommended in patients with a history of depression associated with suicidal ideation or behaviour.
At Daliresp kan forårsage vægttab, og patienter regelmæssigt skal kontrollere og registrere deres vægt på patientkortet. 
That Daliresp may cause weight loss and patients should weigh themselves regularly and record their weight on the patient card.
¾ Den manglende erfaring hos patienter med HIV-infektion eller aktiv hepatitis, med alvorlige immunologiske sygdomme (multipel sklerose, lupus erythematosus, multifokal leukoenkefalopati) eller patienter i immunsupprimerende behandling (andre end korttids-systemiske kortikosteroider). 
¾ The lack of experience in patients with HIV infection or active hepatitis, with severe immunological diseases (e.g. multiple sclerosis, lupus erythematous, multifocal leukoencephalopathy) or treated with immunosuppressive therapy (other than short-term systemic corticosteroids) and that Daliresp should not be initiated or should be stopped in these patients.
• Produktresumé og indlægsseddel for Daliresp. 
• Summary of Product Characteristics and Patient Information Leaflet for Daliresp
den 29. november 2010. 
on 29 November 2010.
Dette sammendrag blev sidst ajourført i 10-2010. 
This summary was last updated in 10-2010.
Vaccinen gives i overensstemmelse med de officielle anbefalinger. 
The vaccine is given according to official recommendations.
Dette er med til at beskytte mod den sygdom, som virussen forårsager. 
This may help to protect against the disease caused by the virus.
En influenzapandemi bryder ud, når der opstår en ny stamme af en influenzavirus, der let kan spredes fra person til person, fordi mennesker ikke har nogen immunitet (beskyttelse) over for den. En pandemi kan berøre de fleste lande og regioner i verden. 
A flu pandemic happens when a new strain of flu virus appears that can spread easily from person to person because people have no immunity (protection) against it. A pandemic can affect most countries and regions around the world.
Vaccinen indeholder visse dele af H5N1-virussen. 
This vaccine contains some parts of the H5N1 virus.
I tilfælde af en pandemi kan det dog være hensigtsmæssigt alligevel at vaccinere sådanne patienter, forudsat at der er genoplivningsudstyr til rådighed. 
However, it may be appropriate to give the vaccine to these patients during a pandemic, as long as facilities for resuscitation are available.
Ifølge de kriterier, der er fastlagt af CHMP, skal en pandemivaccine frembringe en beskyttende mængde antistoffer hos mindst 70 % af de vaccinerede personer, for at den anses for egnet. 
According to criteria laid down by the CHMP, a prepandemic vaccine needs to bring about protective levels of antibodies in at least 70% of people for it to be considered suitable.
CHMP bemærkede, at det er sandsynligt, at en H5N1-stamme af influenzaen vil forårsage en pandemi i fremtiden. 
The CHMP noted that it is likely that a H5N1 strain of the influenza will cause a pandemic in the future.
I undersøgelserne så man på vaccinens evne til at udløse dannelsen af antistoffer ("immunogenicitet") i tråd med CHMP's kriterier for præpandemiske vacciner. 
The studies looked at the ability of the vaccine to trigger the production of antibodies (‘immunogenicity') in line with the CHMP criteria for prepandemic vaccines.
Vaccinen indeholder en "adjuvans" (en olieholdig forbindelse), som giver en bedre immunrespons. 
The vaccine contains an ‘adjuvant' (a compound containing oil) to enhance the immune response.
I den første undersøgelse havde ca. 90 % af personerne under 60 år og ca. 80 % af personerne over 60 år opnået et antistofniveau, der ville beskytte dem mod H5N1, 21 dage efter den anden injektion. 
In the first study, 21 days after the second injection, around 90% of people aged below 60 years and around 80% of those aged above 60 years had levels of antibodies that would protect them against H5N1.
Sundhedseksperter er bekymrede for, at en kommende influenzapandemi kan forårsages af H5N1-stammen af virussen. 
Health experts are concerned that a future flu pandemic could be caused by the H5N1 strain of the virus.
Det er en vaccinetype, som anvendes for at beskytte mod en ny influenzastamme, der eventuelt vil forårsage en influenzapandemi i fremtiden. 
This is a type of vaccine to be used to protect against a new strain of flu that may cause a future influenza pandemic.
Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics må ikke gives til patienter, der har haft en anafylaktisk reaktion (en alvorlig allergisk reaktion) på nogen af vaccinens komponenter, herunder de komponenter, der indgår som sporstoffer (dvs. i meget små mængder), f.eks. æg eller kyllingeprotein, ovalbumin (et protein i æggehvide), kanamycin- og neomycinsulfat (antibiotika), formaldehyd og cetyltrimethylammoniumbromid. 
Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics should not be given to patients who have had an anaphylactic reaction (severe allergic reaction) to any of the components of the vaccine, including those found at trace (very low levels) such as egg or chicken protein, ovalbumin (a protein in egg white), kanamycin or neomycin sulphate (antibiotics), formaldehyde and cetyltrimethylammonium bromide.
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 Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics. 
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 Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics.
Den fuldstændige EPAR for Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnosticsfindes på EMA's websted ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports. 
The full EPAR for Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics can be searched for on the Agency's website ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Når en person får vaccinen, opfatter immunsystemet virusdelene som "fremmede" og danner antistoffer imod dem. Immunsystemet kan således danne antistoffer hurtigere, når det eksponeres for samme virus igen. 
When a person is given the vaccine, the immune system recognises the virus parts as ‘foreign' and makes antibodies against them.
Såfremt der er tale om en officielt erklæret pandemi, der skyldes H5N1-stammen af influenza A, kan personer, der allerede er blevet vaccineret med Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics (med en eller to doser), kun få én dosis mere i stedet for de to doser, der anbefales for ikke-vaccinerede personer. 
In the event of an officially declared pandemic caused by the H5N1 strain of the influenza A, people who have already been vaccinated with Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics (with one or two doses) may be given only one more dose, instead of the two doses recommended for unvaccinated people.
Hvis du ønsker yderligere oplysninger om behandling med Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek. 
For more information about treatment with Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
De mest almindelige bivirkninger ved Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics(som forekommer hos flere end 1 ud af 10 patienter) er hovedpine, myalgi (muskelsmerter), reaktioner på injektionsstedet (hævelse, smerte, hårdhed og rødme) og træthed. 
The most common side effects with Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics (seen in more than 1 patient in 10) are headache, myalgia (muscle pain), reactions at the site of injection (swelling, pain, induration and redness) and fatigue (tiredness).
I en af undersøgelserne, som omfattede 3 372 personer, fik deltagerne enten vaccine mod sæsoninfluenza efterfulgt af to doser Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics med tre ugers mellemrum eller placebo (en virkningsløs vaccine) efterfulgt af to doser af en adjuveret vaccine mod sæsoninfluenza med tre ugers mellemrum. 
In one study involving 3,372 people, subjects were given either a seasonal flu vaccine followed by two doses of Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics three weeks apart, or a placebo (a dummy vaccine) followed by two doses of an adjuvanted seasonal vaccine three weeks apart.
Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics indeholder en influenzastamme kaldet en A/Vietnam/1194/2004 (H5N1)-lignende stamme (NIBRG-14). 
Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics contains a flu strain called A/Vietnam/1194/2004 (H5N1)-like strain (NIBRG-14).
Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnosticstil Novartis Vaccines and Diagnostics S.r.l. 
The European Commission granted a marketing authorisation valid throughout the European Union for Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics to Novartis Vaccines and Diagnostics S.r.l.
Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics er en vaccine, som anvendes til voksne for at beskytte mod influenza, der skyldes H5N1 ("fugleinfluenza")-stammen af influenza A-virus. 
Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics is a vaccine for use in adults to protect against flu caused by the H5N1 (“bird flu”) strain of the influenza A virus.
Ansøgeren fremlagde data om forsøgsmodeller med vacciner, der ligner Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics. 
The applicant presented data on experimental models with vaccines similar to Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics.
Den anden undersøgelse gav dokumentation for, at Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics skulle gives som to doser med mindst tre ugers mellemrum. 
The second study established that Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics should be given as two doses at least three weeks apart.