FrancophonIA/ELRC3.0 huggingface dataset:
English: Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see section 4.4 Special warnings and precautions for use).
Danish: Bivirkningerne kan minimeres ved at anvende den laveste effektive dosis i så kort tid som muligt til at kontrollere symptomerne (se pkt.
English: Do not use diclofenac if you have established heart disease and /or cerebrovascular disease e.g. if you have had a heart attack, stroke, mini-stroke (TIA) or blockages to blood vessels to the heart or brain or an operation to clear or bypass blockages if you have or have had problems with your blood circulation (peripheral arterial disease)
Danish: • hvis De har fået diagnosticeret hjertesygdom og/eller cerebrovaskulær sygdom, f.eks. hvis De har haft et hjertetilfælde, slagtilfælde, forbigående svigt i blodtilførslen til hjernen (TCI = transitorisk cerebral iskæmi) eller blodprop i blodårerne til hjertet eller hjernen, eller hvis De har fået foretaget en ballonudvidelse eller en bypass-operation
English: Side effects may be minimised by using the lowest effective dose for the shortest duration necessary.
Danish: Bivirkningerne kan minimeres ved at bekæmpe symptomerne i så kort tid og med så lav dosis som muligt.
English: The product information may be subsequently updated by the Member State competent authorities, in liaison with the Reference Member State, as appropriate, in accordance with the procedures laid down in Chapter 4 of Title III of Directive 2001/83/EC.
Danish: De relevante nationale myndigheder skal efterfølgende ajourføre produktresuméet og indlægssedlen i overensstemmelse hermed, hvis nødvendigt.
English: Section 4.4 Special warnings and precautions for use: [The wording below should be inserted in this section]
Danish: 4.4 Særlige advarsler og forsigtighedsregler vedrørende brugen [Nedennævnte tekst skal indsættes i dette afsnit]
English: Section 4.3 Contraindications: [The wording below should be inserted in this section]
Danish: 4.3 Kontraindikationer [Nedennævnte tekst skal indsættes i dette afsnit]
English: Section 4.8 Undesirable effects: [The wording below should be inserted in this section]
Danish: 4.8 Bivirkninger [Nedennævnte tekst skal indsættes i dette afsnit]
English: A. Summary of Product Characteristics Section 4.2 Posology and method of administration: [The wording below should be inserted in this section]
Danish: 4.2 Dosering og indgivelsesmåde [Nedenstående tekst skal indsættes i dette punkt]
English: (see section 4.3 and 4.4 for Contraindications and Special warnings and special precautions for use).
Danish: 4.3 og 4.4).
English: Content (concentration)
Danish: Styrke Lægemiddelform Indgivelsesvej Emballage Indhold (Koncentration)
English: 23 May 2014 EMA/232003/2014 EMEA/H/C/000560 EMEA/H/C/000561
Danish: Den 23. maj 2014 EMA/232003/2014 EMEA/H/C/000560 EMEA/H/C/000561
English: Protelos/Osseor has been authorised since September 2004.
Danish: Protelos/Osseor har været godkendt siden september 2004.
English: The full European Public Assessment Report for Protelos/Osseor can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Danish: Den fuldstændige europæiske offentlige vurderingsrapport for Protelos/Osseor findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: The applicant presented data from one main study involving 1,683 patients with osteoarthritis of the knee.
Danish: Ansøgeren fremlagde data fra én hovedundersøgelse, hvori der deltog 1 683 patienter med slidgigt i knæet.
English: How far into the evaluation were the applications when they were withdrawn?
Danish: Hvor langt var vurderingen af ansøgningerne nået, da de blev trukket tilbage?
English: In this study, strontium ranelate 1 or 2 g was compared with placebo (a dummy treatment).
Danish: I undersøgelsen blev strontiumranelat, 1 eller 2 g, sammenlignet med virkningsløs behandling (placebo).
English: They are available as sachets containing strontium ranelate (2 g) as granules to be made up into a suspension to be taken by mouth.
Danish: De fås som breve, der indeholder strontiumranelat (2 g) som et granulat, der skal blandes til en suspension og indtages gennem munden.
English: Protelos/Osseor was also expected to be used to treat osteoarthritis (a long-term disease that damages joints and makes them stiff and painful) in the knee and hip.
Danish: Protelos/Osseor forventedes også anvendt til behandling af slidgigt (osteoarthritis, en langvarig sygdom, der beskadiger leddene og gør dem stive og smertende) i knæ og hofter.
English: The applications were withdrawn after the CHMP had evaluated the documentation provided by the company and formulated lists of questions.
Danish: Ansøgningerne blev trukket tilbage, efter at CHMP havde vurderet virksomhedens dokumentation og stillet en række spørgsmål.
English: The main measure of effectiveness was the effect in slowing the loss of cartilage from the joint as measured by X-rays after 3 years of treatment.
Danish: Behandlingens virkning blev hovedsagelig bedømt på mindskelsen af tabet af ledbrusk, målt ved røntgenfotografering efter 3 års behandling.
English: The company informed the CHMP that there are no consequences for any ongoing clinical trials with Protelos/Osseor.
Danish: Virksomheden har meddelt CHMP, at beslutningen ikke vil få konsekvenser for igangværende kliniske undersøgelser med Protelos/Osseor.
English: Strontium ranelate, the active substance in Protelos/Osseor, is expected to stimulate formation of new cartilage and reduce bone breakdown.
Danish: Strontiumranelat, det aktive stof i Protelos/Osseor, forventes at stimulere dannelsen af ny ledbrusk og mindske nedbrydningen af knoglen.
English: What is Protelos/Osseor?
Danish: Hvad er Protelos/Osseor?
English: What were the reasons given by the company for withdrawing the applications?
Danish: Hvilken begrundelse gav virksomheden for tilbagetrækningen af ansøgningerne?
English: On 21 March 2014, Les Laboratoires Servier officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its applications to extend the indication of Protelos/Osseor to include the treatment of osteoarthritis of the knee and hip.
Danish: Den 21. marts 2014 meddelte Les Laboratoires Servier officielt til Udvalget for Lægemidler til Mennesker (CHMP), at virksomheden ønsker at trække sine ansøgninger tilbage om udvidelse af anvendelsen af Protelos/Osseor til slidgigt i knæ og hofter.
English: There are no consequences on the use of Protelos/Osseor in its authorised indications.
Danish: Afgørelsen vil ikke få konsekvenser for anvendelsen af Protelos/Osseor til de godkendte indikationer.
English: Therefore, at the time of the withdrawal, the CHMP was of the opinion that the benefits of Protelos/Osseor in the treatment of osteoarthritis did not outweigh its risks.
Danish: På tilbagetrækningstidspunktet var CHMP derfor af den opfattelse, at fordelene ved Protelos/Osseor til behandling af slidgigt ikke var større end risiciene.
English: In its letter notifying the Agency of the withdrawal of the applications, the company stated that the withdrawal was due to the fact that the data so far available were insufficient to address the CHMP's concerns.
Danish: I sit brev til agenturet om tilbagetrækningen af ansøgningerne anførte virksomheden, at tilbagetrækningen skyldtes, at den ikke så sig i stand til at imødekomme CHMP's betænkeligheder ved hjælp af de hidtil foreliggende data.
English: Protelos and Osseor are identical medicines that contain the active substance strontium ranelate.
Danish: Protelos/Osseor er to ens lægemidler, der indeholder det aktive stof strontiumranelat.
English: Based on the review of the data and the company's response to the CHMP lists of questions, at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Protelos/Osseor could not have been approved for the treatment of osteoarthritis.
Danish: På baggrund af gennemgangen af dataene og virksomhedens besvarelse af CHMP's spørgsmål havde CHMP på tidspunktet for tilbagetrækningen af ansøgningerne visse betænkeligheder og var af den foreløbige opfattelse, at Protelos/Osseor ikke kunne godkendes til behandling af slidgigt.
English: stiffness when the joint moves.
Danish: Dette medfører smerter og stivhed, når leddet bevæges.
English: It is currently used to treat severe osteoporosis (a disease that makes bones fragile) in post-menopausal women and men who have a high risk of fracture.
Danish: De anvendes på nuværende tidspunkt til behandling af svær knogleskørhed (osteoporose) hos kvinder efter overgangsalderen og hos mænd med høj risiko for knoglebrud.
English: What was Protelos/Osseor expected to be used for?
Danish: Hvad forventedes Protelos/Osseor anvendt til?
English: The CHMP noted that the size of the benefit seen in the study was small and the long-term benefit unclear, whereas the medicine had an established risk of serious side effects.
Danish: CHMP bemærkede, at undersøgelsen kun havde vist lille fordel, og at den langsigtede fordel var uklar, hvorimod det havde vist sig, at lægemidlet medførte risiko for alvorlige bivirkninger Desuden havde udvalget visse betænkeligheder ved den måde, som tabet af ledbrusk var blevet bedømt på.
English: What is happening with Protelos/Osseor for the treatment of osteoporosis?
Danish: Hvad vil der ske med brugen af Protelos/Osseor til behandling af knogleskørhed?
English: What consequences does this withdrawal have for patients in clinical trials or compassionate use programmes?
Danish: Hvilke konsekvenser har tilbagetrækningen for patienter, der deltager i kliniske undersøgelser med Protelos/Osseor eller i programmer for anvendelse af Protelos/Osseor med særlig udleveringstilladelse?
English: How is Protelos/Osseor expected to work?
Danish: Hvordan forventes Protelos/Osseor at virke?
English: What did the company present to support its applications?
Danish: Hvilken dokumentation fremlagde virksomheden i forbindelse med ansøgningerne?
English: In osteoarthritis, the cartilage, a smooth layer that lines the joints and helps them to move easily, is gradually lost, and the bone underneath becomes damaged and exposed.
Danish: Slidgigt medfører gradvis nedbrydning af ledbrusken, som er det glatte lag, der beklæder leddene og får dem til at arbejde let.
English: Invented Strength Pharmaceutical Form Route of Administration
Danish: MF (EU)-nummer Særnavn Styrke Lægemiddelform Administration Emballage Indhold
English: MA (EU) number (Invented) name Strength
Danish: MF (EU)-nummer (Særnavn) Navn
English: Immediate Packaging
Danish: 6 fyldte opløsning intravenøs anvendelse
English: 5 million cells/ml Suspension for injection
Danish: 5 millioner celler/ml
English: 4 vials
Danish: 4 hætteglas
English: Intralesional use vial (glass)
Danish: Intralæsional anvendelse hætteglas (glas) 6 ml
English: Route of Administration
Danish: Lægemiddelform Administration Emballage
English: The European Commission granted a marketing authorisation valid throughout the European Union for Gardasil on 20 September 2006.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Gardasil den 20. september 2006.
English: This document is a summary of the European public assessment report (EPAR) for Gardasil.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Gardasil.
English: Vaccination should be postponed in patients who are ill with a high fever.
Danish: Vaccinationen skal udskydes hos patienter, der har høj feber.
English: • genital warts.
Danish: • kønsvorter.
English: The full EPAR for Gardasil can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Danish: Den fuldstændige EPAR for Gardasil findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: These virus-like particles are not capable of causing infection.
Danish: Disse viruslignende partikler kan ikke forårsage infektion.
English: Gardasil is a vaccine.
Danish: Gardasil er en vaccine.
English: Gardasil is given according to official recommendations.
Danish: Gardasil administreres i henhold til de officielle anbefalinger.
English: There are more than 100 types of papillomavirus, some of which are associated with genital cancers.
Danish: Der findes over 100 typer papillomavirus, hvoraf nogle er forbundet med genitale kræftformer.
English: The vaccine is given as an injection into a muscle, preferably in the shoulder or the thigh.
Danish: Vaccinen gives som en injektion i en muskel, fortrinsvis i skulderen eller låret.
English: A risk management plan has been developed to ensure that Gardasil is used as safely as possible.
Danish: Der er udarbejdet en risikostyringsplan for at sikre, at Gardasil anvendes så sikkert som muligt.
English: Human papillomaviruses are viruses that cause warts and abnormal tissue growth.
Danish: Humane papillomavira er vira, der forårsager vorter og abnorm vævsvækst.
English: These same three doses can also be used in individuals aged nine to thirteen years.
Danish: Disse samme tre doser kan også anvendes hos personer i alderen 9-13 år.
English: The proteins are assembled in ‘virus-like particles' (structures that look like HPV, so that the body can recognise them easily).
Danish: Disse samler sig i »virusagtige partikler« (strukturer, som ligner HPV-virus, således at kroppen nemt kan genkende dem).
English: After vaccination, the immune system is able to produce antibodies more quickly when it is exposed to the real viruses.
Danish: Efter vaccinationen er immunsystemet i stand til hurtigere at producere antistoffer, hvis det igen udsættes for de rigtige vira.
English: There should always be at least one month between the first and the second doses, and at least three months between the second and the third, and all doses should be given within a year.
Danish: Der skal altid gå mindst en måned mellem den første og den anden dosis og mindst tre måneder mellem den anden og den tredje, og alle doser skal gives inden for ét år.
English: For more information about treatment with Gardasil, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Gardasil, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: Patients who show signs of an allergy after a dose of Gardasil should not receive further doses of the vaccine.
Danish: Patienter, som viser tegn på en allergisk reaktion efter dosering med Gardasil, må ikke administreres yderligere doser af lægemidlet.
English: • precancerous lesions (growths) in the cervix, vulva or vagina and anus;
Danish: • præcancerøse læsioner (vækster) i livmoderhalsen, de ydre kønsdele eller vagina og anus
English: What measures are being taken to ensure the safe and effective use of Gardasil?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Gardasil?
English: The vaccine also contains an ‘adjuvant' (a compound containing aluminium) to stimulate a better response.
Danish: Vaccinen indeholder desuden en »adjuvans« (en aluminiumholdig forbindelse), som giver en bedre respons.
English: If the second dose is given earlier than six months after the first dose, a third dose should always be given.
Danish: Hvis den anden dosis gives tidligere end seks måneder efter den første dosis, skal der altid gives en tredje dosis.
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 Gardasil.
Danish: Det forklarer, hvordan Udvalget for Lægemidler til Mennesker (CHMP) vurderede lægemidlet og nåede frem til sin udtalelse til fordel for udstedelse af en markedsføringstilladelse og til sine anbefalinger om, hvordan Gardasil skal anvendes.
English: The women were followed up for around three years after the third dose of the vaccine.
Danish: Kvinderne blev fulgt i tre år, efter at de havde fået den tredje dosis.
English: Other information about Gardasil:
Danish: Andre oplysninger om Gardasil
English: In contrast, there was a total of 189 cases of external genital lesions out of almost 8,000 women in the placebo group.
Danish: I modsætning hertil var der i alt 189 tilfælde af eksterne genitale læsioner blandt de næsten 8 000 kvinder i placebogruppen.
English: It is a suspension for injection that contains purified proteins for four types of the human papillomavirus (types 6, 11, 16 and 18).
Danish: Det er en suspension til injektion, som indeholder oprensede proteiner fra fire typer af det humane papillomavirus (type 6, 11, 16 og 18).
English: All papillomaviruses have a shell, or ‘capsid', that is made up of proteins called ‘L1 proteins'.
Danish: Alle papillomavira har en skal, eller et »kapsid«, der består af proteiner, som kaldes »L1-proteiner«.
English: When a patient is given the vaccine, the immune system makes antibodies against the L1 proteins.
Danish: Når vaccinen administreres til en patient, danner immunsystemet antistoffer mod L1-proteinerne.
English: The CHMP decided that Gardasil's benefits are greater than its risks and recommended that it be given marketing authorisation.
Danish: CHMP besluttede, at fordelene ved Gardasil opvejer risiciene, og anbefalede udstedelse af en markedsføringstilladelse for Gardasil.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Gardasil, including the appropriate precautions to be followed by healthcare professionals and patients.
Danish: På baggrund af denne er der anført sikkerhedsoplysninger i produktresuméet og indlægssedlen for Gardasil, herunder passende forholdsregler, som patienter og sundhedspersonale skal følge.
English: In studies, the most common side effects with Gardasil (seen in more than 1 patient in 10) were headache and reactions at the site of the injection (redness, pain and swelling).
Danish: I undersøgelserne var de hyppigste bivirkninger ved Gardasil (som optrådte hos flere end 1 ud af 10 patienter) hovedpine og reaktioner på injektionsstedet (rødmen, smerter og hævelse).
English: Gardasil is used in males and females from the age of nine years to protect against the following conditions caused by specific types of human papillomavirus (HPV):
Danish: Gardasil anvendes til mænd/drenge og kvinder/piger på ni år og derover til beskyttelse mod følgende tilstande forårsaget af specifikke typer af human papillomavirus (HPV):
English: In contrast, 85 of the more than 8,000 women who received the placebo vaccine developed lesions that were due to these two HPV types.
Danish: I modsætning hertil udviklede 85 af de over 8 000 kvinder, som fik en placebovaccine, læsioner forårsaget af disse to HPV-typer.
English: There were no cases of anal cancer in the study but it is expected that protection against precancerous anal lesions will translate into protection against the cancer.
Danish: Der var ingen tilfælde af analkræft i undersøgelsen, men beskyttelsen mod præcancerøse anallæsioner forventes at give en tilsvarende beskyttelse mod analkræft.
English: What is the risk associated with Gardasil?
Danish: Hvilken risiko er der forbundet med Gardasil?
English: HPV types 6 and 11 cause approximately 90% of genital warts.
Danish: HPV-type 6 og 11 er årsag til ca. 90 % af alle tilfælde af kønsvorter.
English: The studies also showed that the vaccine stimulates the production of sufficient amounts of antibodies against HPV in girls and boys aged between nine and 15 years.
Danish: Undersøgelserne viste også, at vaccinen stimulerer produktionen af tilstrækkelige mængder antistoffer mod HPV hos piger og drenge i alderen 9-15 år.
English: With regard to precancerous anal lesions, there 5 cases in the vaccinated group (consisting of around 200 patients) compared with 24 cases in the placebo group (which also had around 200 patients).
Danish: Med hensyn til præcancerøse anallæsioner var der fem tilfælde heraf i den gruppe, der fik vaccinen (ca. 200 patienter), sammenlignet med 24 tilfælde i placebogruppen (som også omfattede ca. 200 patienter).
English: HPV types 16 and 18 cause approximately 70% of cervical cancers and between 75 and 80% of anal cancers.
Danish: HPV type 16 og 18 er årsag til ca. 70 % af alle tilfælde af livmoderhalskræft og mellem 75 og 80 % af alle tilfælde af analkræft.
English: Gardasil human papillomavirus vaccine [types 6, 11, 16, 18] (recombinant, adsorbed)
Danish: Gardasil human papillomavirusvaccine [type 6, 11, 16 og 18] (rekombinant, adsorberet)
English: It is recommended that individuals who receive the first dose of Gardasil should complete the dosing regimen with Gardasil.
Danish: Det anbefales, at personer, der får den første dosis Gardasil, gennemfører hele Gardasildoseringsregimet.
English: The studies looked at how many women developed genital lesions or warts that were due to HPV infection.
Danish: I undersøgelserne blev det undersøgt, hvor mange af kvinderne der udviklede genitale læsioner eller vorter, der skyldtes HPVinfektion.
English: For the full list of all restrictions, see the package leaflet.
Danish: Den fuldstændige liste over begrænsninger fremgår af indlægssedlen.
English: A similar effect of Gardasil was seen when the analysis also included lesions of the cervix due to the other two HPV types (types 6 and 11).
Danish: En tilsvarende virkning af Gardasil sås, når analysen også omfattede læsioner i livmoderhalsen, som skyldes de andre to HPV-typer (type 6 og 11).
English: In four main studies of Gardasil given as three dose, Gardasil was compared with placebo (a dummy vaccine) in almost 21,000 women aged between 16 and 26 years.
Danish: I fire hovedundersøgelser af Gardasil givet som tre doser, blev Gardasil sammenlignet med placebo (en virkningsløs vaccine) hos næsten 21 000 kvinder i alderen 16-26 år.
English: Why has Gardasil been approved?
Danish: Hvorfor blev Gardasil godkendt?
English: The main measure of effectiveness was the development of antibodies against HPV types 6, 11, 16 and 18 one month after the last dose.
Danish: Virkningen blev hovedsagelig målt på dannelsen af antistoffer mod HPV-type 6, 11, 16 og 18 en måned efter den sidste dosis.
English: In the study boys and men, there were 3 cases genital lesions among around 1,400 patients given the vaccines compared with 32 cases among around 1,400 given placebo.
Danish: I undersøgelserne hos drenge og mænd var der tre tilfælde af genitale læsioner blandt de ca. 1 400 patienter, der modtog vaccinerne, sammenlignet med 32 tilfælde blandt de ca. 1 400 patienter, der fik placebo.
English: For people aged nine to thirteen years, Gardasil can be given as two doses six months apart.
Danish: Hos personer i alderen 9-13 år kan Gardasil gives som to doser med seks måneders mellemrum.
English: • cervical and anal cancers;
Danish: • livmoderhalskræft og analkræft
English: For people aged fourteen or above, Gardasil is normally given according to a three-dose schedule with the second dose given two months after the first and the third given four months after the second.
Danish: Hos personer på 14 år og derover gives Gardasil normalt ifølge et tredosisprogram, hvor den anden dosis gives to måneder efter den første, og den tredje dosis gives fire måneder efter den anden.
English: In the four studies in 21,000 women, out of the more than 8,000 women vaccinated with Gardasil who had never been infected by HPV types 6, 11, 16 or 18 before, one woman developed a precancerous lesion in the cervix that might have been due to HPV type 16 or 18.
Danish: De fire undersøgelser hos 21 000 kvinder viste, at ud af de over 8 000 kvinder, der var vaccineret med Gardasil og aldrig havde været inficeret med HPV-type 6, 11, 16 og 18, var der én kvinde, der udviklede en præcancerøs læsion i livmoderhalsen, som kunne skyldes HPV 16 eller 18.