natgillin/translations-raw huggingface dataset:
Den rekonstituerede Zoledronsyre Actavis opløsning må ikke blandes med calciumholdige eller andre divalente kationholdige opløsninger som lakteret Ringers væske. 
Do not mix Zoledronic acid Actavis concentrate with calcium-containing or other divalent cation containing solutions such as lactated Ringer's solution.
Actavis Italy S.p.A Via Pastiur. 
Actavis Italy S.p.A Via Pasteur, 10 20014 Nerviano (MI) Italy
Hvor ofte skal du have Zoledronsyre Actavis 
How often Zoledronic acid Actavis is given
Hvordan får du Zoledronsyre Actavis 
How to store Zoledronic acid Actavis
− Spørg lægen, apoteket eller sygeplejersken, hvis der er mere, du vil vide. 
- If you have any further questions, ask your doctor, pharmacist or nurse.
Før indgift af Zoledronsyre Actavis skal patienterne vurderes med henblik på at sikre, de er vel hydrerede. 
Patients must be assessed prior to administration of Zoledronic acid Actavis to ensure that they are adequately hydrated.
4.1 og 4.2, er en akut fasereaktion almindeligvis blevet indrapporteret med symptomer som knoglesmerter, feber, træthed, artralgi, myalgi, stivhed og artritis med efterfølgende hævelse af led. 
Within three days after zoledronic acid administration, used as indicated in sections 4.1 and 4.2, an acute phase reaction has commonly been reported, with symptoms including bone pain, fever, fatigue, arthralgia, myalgia, rigors and arthritis with subsequent joint swelling; these symptoms usually resolve within a few days (see description of selected adverse reactions).
Zoledronsyre Actavis 4 mg/5 ml koncentrat til infusionsvæske, opløsning rekonstitueret yderligere i 100 ml (se pkt. 
Zoledronic acid Actavis 4 mg/5 ml concentrate for solution for infusion, further diluted in 100 ml (see section 6.6), should be given as a single intravenous infusion in no less than 15 minutes.
Det skal du vide, før du får Zoledronsyre Actavis Sådan bliver du behandlet med Zoledronsyre Actavis Bivirkninger 
What Zoledronic acid Actavis is and what it is used for What you need to know before you are given Zoledronic acid Actavis How Zoledronic acid Actavis is used Possible side effects
Koncentrat til infusionsvæske, opløsning (sterilt koncentrat) Klart og farveløst koncentrat til infusionsvæske, opløsning. 
Concentrate for solution for infusion (sterile concentrate).
Hvor meget Zoledronsyre Actavis skal du have 
How much Zoledronic acid Actavis is given
Zoledronsyre Actavis 4 mg/5 ml koncentrat til infusionsvæske, opløsning 
Zoledronic acid Actavis 4 mg/5 ml concentrate for solution for infusion
Instruktion i fremstilling af reducerede doser Zoledronsyre Actavis Udtag en passende volumen af koncentratet efter følgende: 
Instructions for preparing reduced doses of Zoledronic acid Actavis Withdraw an appropriate volume of the concentrate needed, as follows: - 4.4 ml for 3.5 mg dose
− Opbevar Zoledronsyre Actavis utilgængeligt for børn. 
- Keep Zoledronic acid Actavis out of the sight and reach of children.
Øgninger i serumkreatinin og serumurea, hypocalcæmi 
Blood creatinine and blood urea increased, hypocalcaemia
Zoledronsyre Actavis 4 mg/5 ml koncentrat til infusionsvæske, opløsning zoledronsyre 
Zoledronic acid Actavis 4 mg/5 ml concentrate for solution for infusion zoledronic acid
Placebo Δ Zoledronic 
Placebo Zoledronic acid
Hvordan skal Zoledronsyre Actavis opbevares 
How Zoledronic acid Actavis is given
Nedsat nyrefunktion, osteonekrose af kæberne, akut fasereaktion, hypocalcæmi, atrieflimren, anafylaksi, interstitiel lungesygdom. 
The following are the important identified risks with zoledronic acid in the approved indications: Renal function impairment, osteonecrosis of the jaw, acute phase reaction, hypocalcaemia, atrial fibrillation, anaphylaxis, interstitial lung disease.
Der er kun begrænsede farmakokinetiske data vedrørende patienter med svær nyreinsufficiens 
Only limited pharmacokinetic data are available in patients with severe renal insufficiency (creatinine clearance < 30 ml/min).
Infusionen bør vare mindst 15 minutter og skal gives som en enkelt intravenøs infusion i en separat infusionsslange. 
- Zoledronic acid Actavis is given as a drip (infusion) into a vein which should take at least 15 minutes and should be administered as a single intravenous solution in a separate infusion line.
Zoledronsyre Actavis, anvendt som indikeret under pkt. 
What Zoledronic acid Actavis is and what it is used for
Hvid du ønsker yderligere oplysninger om Zoledronsyre Actavis, skal du henvende dig til den lokale repræsentant: 
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Clopidogrel 1A Pharma til Acino Pharma GmbH den 28. juli 2009. 
The European Commission granted a marketing authorisation valid throughout the EU for Clopidogrel 1A Pharma to Acino Pharma GmbH on 28 July 2009.
Ved akut koronarsyndrom anvendes Clopidogrel 1A Pharma sammen med aspirin, og behandlingen indledes almindeligvis med en startdosis på fire 75 mg-tabletter. 
In acute coronary syndrome, Clopidogrel 1A Pharma is used together with aspirin and treatment generally starts with a loading dose of four 75 mg tablets.
Standarddosis af Clopidogrel 1A Pharma er 75 mg en gang dagligt med eller uden et måltid. 
The standard dose of Clopidogrel 1A Pharma is one 75 mg tablet once a day, taken with or without food.
Clopidogrel 1A Pharma anvendes til forebyggelse af aterotrombotiske hændelser hos voksne (problemer forårsaget af blodpropper og åreforkalkning). 
Clopidogrel 1A Pharma is used in adults to prevent atherothrombotic events (problems caused by blood clots and hardening of the arteries).
Clopidogrel 1A Pharma kan anvendes til patienter, som har myokardieinfarkt med ”forhøjelse af STsegmentet” (ST-elevation), dvs. en unormal visning på elektrokardiogrammet (EKG), når lægen vurderer, at patienterne kan have gavn af denne behandling. 
Clopidogrel 1A Pharma can be used in patients who are having myocardial infarction with ‘ST segment elevation' (an abnormal reading on the electrocardiogram or ECG) when the doctor thinks that they would benefit from the treatment.
Det betyder, at Clopidogrel 1A Pharma er identisk med et referencelægemiddel, der allerede er godkendt i Den Europæiske Union, kaldet Plavix. 
This means that Clopidogrel 1A Pharma is similar to a ‘reference medicine' already authorised in the European Union (EU) called Plavix.
Udvalget for Humanmedicinske Lægemidler (CHMP) konkluderede, at Clopidogrel 1A Pharma i overensstemmelse med EU-kravene har vist sig at være af sammenlignelig kvalitet og at være bioækvivalent med Plavix. 
The Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Clopidogrel 1A Pharma has been shown to have comparable quality and to be bioequivalent to Plavix.
• patienter med perifere kredsløbsforstyrrelser (problemer med blodgennemstrømningen i 
• patients with peripheral arterial disease (problems with blood flow in the arteries);
Behandling med Clopidogrel 1A Pharma kan påbegyndes få dage efter anfaldet og indtil 35 dage efter, 
Clopidogrel 1A Pharma can be started between a few days and 35 days after the attack;
Da Clopidogrel 1A Pharma er et generisk lægemiddel, der er bioækvivalent med referencelægemidlet, anses benefit/risk-forholdet for at være det samme som for referencelægemidlet. 
Because Clopidogrel 1A Pharma is a generic medicine and is bioequivalent to the reference medicine, its benefit and risk are taken as being the same as those of the reference medicine.
Clopidogrel 1A Pharma er et lægemiddel, der indeholder det aktive stof clopidogrel. 
Clopidogrel 1A Pharma is a medicine that contains the active substance clopidogrel.
Da Clopidogrel 1A Pharma er et generisk lægemiddel, har undersøgelserne været begrænset til at påvise, at det er bioækvivalent med referencelægemidlet Plavix. 
Because Clopidogrel 1A Pharma is a generic medicine, studies have been limited to tests to determine that it is bioequivalent to the reference medicine, Plavix.
Hvilken fordel og risiko er der forbundet med Clopidogrel 1A Pharma? 
What are the benefit and risk of Clopidogrel 1A Pharma?
Den fuldstændige EPAR for Clopidogrel 1A Pharma findes her. 
The full EPAR for Clopidogrel 1A Pharma can be found here.
Behandlingen med Clopidogrel 1A Pharma kan påbegyndes 7 dage efter slagtilfældet og indtil 6 måneder efter, 
Clopidogrel 1A Pharma can be started between seven days and six months after
Det aktive stof i Clopidogrel 1A Pharma, clopidogrel, er et blodpladeaggregationshæmmende middel. 
The active substance in Clopidogrel 1A Pharma, clopidogrel, is an inhibitor of platelet aggregation.
Det fås som Clopidogrel 1A er et ‘generisk lægemiddel'. 
Clopidogrel 1A Pharma is a ‘generic medicine'.
Hvordan anvendes Clopidogrel 1A Pharma? 
How is Clopidogrel 1A Pharma used?
Udvalget anbefalede udstedelse af markedsføringstilladelse for Clopidogrel 
The Committee recommended that Clopidogrel 1A Pharma be given marketing authorisation.
Clopidogrel 1A Pharma kan gives til 
Clopidogrel 1A Pharma can be given to the following groups of patients:
Hvordan virker Clopidogrel 1A Pharma? 
What is Clopidogrel 1A Pharma?
Resultaterne var heterogene og inkonsekvente. 
Results are heterogeneous and inconsistent.
Tilgængelige data tyder faktisk på en sådan årsagssammenhæng. 
Available data is in fact indicative of such causal relationship.
Dets virkning skyldes primært dens α1blokerende egenskaber. 
Its effect results mainly from its α1-blocking properties.
Benefit/risk-forholdet 
Benefit -risk balance
Det giver et fald i blodtrykket og en stigning i det perifere blodomløb. 
It produces a decrease in blood pressure and an increase in peripheral blood flow.
Sådanne bivirkningers sværhedsgrad og deres mulige dødelige udfald understreges. 
The seriousness of such adverse effects and their possible fatal outcome is underlined.
Derfor anbefaler CHMP i henhold til artikel 116 i direktiv 2001/83/EF følgende: 
Therefore, in accordance with Article 116 of Directive 2001/83/EC, the CHMP recommends:
Underrapportering kan også mistænkes, fordi stoffet har været på markedet i lang tid, og fordi fibrose allerede er nævnt som en bivirkning i produktinformationen. 
Under-reporting can also be suspected because the substance has been on the market for a long time and because fibrosis is already mentioned as an undesirable effect in the product information.
Begrundelser for ændring/suspendering af betingelserne for markedsføringstilladelserne 
Grounds for the variation/suspension to the terms of the marketing authorisations
Samlet resumé af den videnskabelige vurdering af lægemidler, der indeholder dihydroergocristin (se bilag I). 
Overall summary of the scientific evaluation of dihydroergocristine containing medicinal products (see Annex I)
I Europa fås dihydroergocristin også i kombination med etofyllinum. 
In Europe, dihydroergocristine is also available in combination with etofyllinum.
Den 18. januar 2012 indbragte Frankrig en sag i henhold til artikel 31 i direktiv 2001/83/EF for følgende lægemidler, der indeholder ergotderivater: dihydroergocryptin/koffein, dihydroergocristin, dihydroergotamin, dihydroergotoxin og nicergolin. 
On 18 January 2012, France triggered a referral under Article 31 of Directive 2001/83/EC for the following ergot derivatives containing medicinal products: dihydroergocryptine/caffeine, dihydroergocristine, dihydroergotamine, dihydroergotoxine and nicergoline.
Der var 3 placebokontrollerede undersøgelser med en undersøgelsespopulation på 200-240 patienter. 
There were 3 placebo controlled studies with a study population of 200-240 patients.
• Udvalget er af den opfattelse, at beviserne for klinisk signifikant virkning af dihydroergocristin i de aktuelt vurderede indikationer er meget begrænsede, hvorfor den potentielle fordel for patienter i disse indikationer opvejes af de ovenfor identificerede risici. 
• The Committee is of the opinion that the evidence for clinically significant efficacy of dihydroergocristine in the currently assessed indications is very limited, and therefore the potential benefit for patients in these indications is outweighed by the above identified risk.
CHMP har gennemgået de samlede tilgængelige data om dihydroergocristins sikkerhed og virkning. 
The CHMP has considered the totality of the available data on the safety and efficacy of dihydroergocristine.
I denne undersøgelse, der lever op til en tilstrækkelig metodisk kvalitet, blev der imidlertid observeret en ikke-signifikant forskel mellem dihydroergocristin + raubasin-gruppen og placebogruppen. 
However, in this study with adequate methodological quality standard, non-significant difference between dihydroergocristine + raubasine and placebo groups was observed.
CHMP blev derfor anmodet om at afgive en udtalelse om, hvorvidt markedsføringstilladelserne for lægemidler, der indeholder ergotderivater, bør opretholdes, ændres, suspenderes eller tilbagekaldes for så vidt angår de nedenfor angivne indikationer: 
The CHMP was therefore requested to give its opinion on whether the marketing authorisations for ergot derivatives containing medicinal products should be maintained, varied, suspended or withdrawn in relation to the below mentioned indications:
• Udvalget vurderede proceduren i henhold til artikel 31 i direktiv 2001/83/EF for lægemidler, der indeholder ergotderivater, ved de berørte indikationer. 
• The Committee considered the procedure under Article 31 of Directive 2001/83/EC for ergot derivatives containing medicinal products in the concerned indications.
CHMP var af den opfattelse, at der ud fra disse undersøgelser ikke kunne drages nogen konklusion om virkningen. 
The CHMP was of the opinion that no efficacy conclusion could be drawn based on these studies.
Af disse var 18 placebokontrollerede undersøgelser, 2 var aktivt kontrollerede undersøgelser, og 7 var åbne undersøgelser. 
Of these, 18 concerned placebocontrolled trials, 2 concerned actively-controlled trials and 7 concerned open label studies.
En gennemgang af alle andre tilgængelige data (dvs. litteraturoplysninger, prækliniske data og andre kliniske data, herunder epidemiologiske undersøgelser) af relevans for vurderingen af risikoen for fibrose blev tilvejebragt i det omfang, det var muligt. 
A review of all other available data (i.e. literature data, pre-clinical data, and other clinical data including epidemiological studies) that were relevant to evaluate the risk of fibrosis was provided where possible.
Skønt enkelte af de foreslåede foranstaltninger kunne medvirke til at identificere patienter med præeksisterende fibrose, relevant samtidig lægemiddelbehandling og øget risiko, påpegede udvalget, at foranstaltningerne ikke er tilstrækkelige til at undgå, at nogle patienter under behandlingen udvikler fibrose og ergotisme. 
Although some of the proposed measures could help identify patients with pre-existing fibrosis, relevant concomitant medication and increased risk, the Committee pointed out that they are insufficient to avoid that some patients develop fibrosis and ergotism during treatment.
• otostatisk hypotension 
• Orthostatic hypotension
Lignende resultater foreligger fra seks af de evaluérbare undersøgelser med en population på under 100 patienter. 
In six of the evaluable studies with population under 100 patients there were similar findings.
Af de 6 randomiserede, dobbeltblinde, placebokontrollerede undersøgelser vurderede CHMP, at 5 undersøgelser ikke var relevante, fordi definitionen af diagnosen ikke var standardiseret, fordi intet primært effektkriterium blev udvalgt blandt den multidimensionale vurdering, fordi antallet af patienter pr. gruppe var lille (47-65), og fordi behandlingsvarigheden var kort (2 og 3 måneder). 
Of the 6 randomised, double blind, placebo-controlled studies, 5 studies were not considered relevant by the CHMP because the definition of the diagnosis was not standardised, no primary efficacy criterion was selected among the multi-dimensional assessment, the number of patients per group was small (from 47 to 65), and the treatment duration was short (2 and 3 months).
Alzheimers sygdom og anden demens) 
(excluding Alzheimer's disease and other dementia)
Desuden blev det påpeget, at topiske instillationer med dihydroergocristin ligger uden for denne procedures anvendelsesområde. 
Moreover, it was pointed out that topical instillations of dihydroergocristine are out of the scope of this procedure.
Gruppen understregede, at den ansøgte indikation ikke længere anvendes i klinisk praksis, og at der ud fra et klinisk synspunkt på nuværende tidspunkt ikke er beviser for et terapeutisk behov for dette aktive stof ved behandling af kognitiv og neurosensorisk funktionsnedsættelse hos ældre. 
The group highlighted that the claimed indication is not used anymore in the clinical practice and that from a clinical viewpoint there is no evidence at present that there is a therapeutic need for this active substance in the treatment of cognitive and neurosensorial impairment in the elderly.
• Udvalget noterede sig de overordnede data indgivet af indehaverne af markedsføringstilladelsen samt den videnskabelige rådgivende gruppes resultater. 
• The Committee considered the overall submitted data provided by the MAHs and the outcome of the scientific advisory group.
Der findes yderligere 2 undersøgelser af Hugonot et al, der omfattede en population på 114-127 patienter, og som begge påviste overlegenhed i forhold til placebo. 
There are 2 further studies by Hugonot et al with population of 114-127 patients, both showing superiority over placebo.
Blandt disse 3 undersøgelser blev der i publikationer fra Lazzaroni et al og Aranda et al påvist overlegenhed i forhold til placebo, mens undersøgelsen fra Vellas et al viste lignende virkning for placebo. 
Among these 3 studies, the publications by Lazzaroni et al and Aranda et al indicated superiority over placebo, while the study by Vellas et al demonstrated similar efficacy to placebo.
• suspendering af markedsføringstilladelsen for lægemidler, der indeholder dihydroergocristin, som omhandlet i bilag I, såfremt der i markedsføringstilladelsen ikke er godkendt andre indikationer. 
• The suspension of the marketing authorisation for dihydroergocristine containing medicinal products referred to in Annex I in the event that no other indications are approved as part of their marketing authorisation.
For at ophæve suspenderingen skal indehaverne af markedsføringstilladelsen identificere en specifik patientpopulation, hos hvem fordelene ved lægemidlet opvejer de fundne risici. 
In order to lift the suspension, MAHs must identify a specific patient population for which the benefits of the product outweigh the identified risk.
Efter en national gennemgang af lægemiddelovervågningen i 2011 blev der gennem nye spontane indberetninger om enkelte af disse lægemidler identificeret alvorlige tilfælde af fibrose og ergotisme, og Frankrig mente, at dette sikkerhedsproblem ikke opvejes af den begrænsede dokumentation for virkningen. 
Following a national pharmacovigilance review held in 2011 new spontaneous notifications reported with some of those products identified serious cases of fibrosis and ergotism and France considered that this safety concern is not outweighed by the limited evidence of efficacy.
Indehaverne af markedsføringstilladelsen forelagde alle tilgængelige data om virkning fra kliniske undersøgelser og observationsstudier, herunder oplysninger offentliggjort siden udstedelsen af den oprindelige markedsføringstilladelse. 
The marketing authorisation holders (MAHs) submitted all available efficacy data from clinical trials and observational studies, including data that became available since the granting of the initial marketing authorisation.
Den seneste undersøgelse (Vellas 1998 - ikke offentliggjort), som blev gjort tilgængelig efter udstedelsen af den oprindelige markedsføringstilladelse, anvender en standarddefinition for diagnosen (patienterne skulle have et moderat hukommelsestab med en MMSE-score (Mini-Mental Sate Examination) > 25 og en totalscore > 38 og < 70 på Mac Nair og Kahns spørgeskema til selvvurdering af vanskeligheder ved daglige aktiviteter) og foruddefinerer det primære effektkriterium (Mac Nair og Kahns selvvurderingsspørgeskema samt Gröber og Buschkes test). 
The most recent study (Vellas 1998 - Not published) that became available after the granting of the initial marketing autohrisation, uses a standardised definition of diagnosis (patients had to present a moderate memory deficit, with a Mini-Mental Sate Examination MMSE > 25 and a score total > 38 and < 70 on the Mac Nair and Kahn auto-questionnaire assessing the difficulties in daily activities) and defines the primary efficacy criterion a priori (the Mac Nair and Kahn auto-questionnaire and the Gröber and Buschke test).
Videnskabelige konklusioner og begrundelser for ændring af betingelserne for markedsføringstilladelserne eller for suspendering af markedsføringstilladelserne under hensyntagen til de godkendte indikationer for hvert lægemiddel 
Scientific conclusions and grounds for variation to the terms of the marketing authorisations or suspension of the marketing authorisations, as applicable, taking into consideration the approved indications for each product
Desuden har det en farmakologisk virkning på serotoninerge og dopaminerge receptorer, der medfører interessante virkninger på den cerebrale metabolisme. 
In addition it has a pharmacological action on the serotoninergic and dopaminergic receptors leading to interesting effects on cerebral metabolism.
• Udvalget vurderede, at der ikke kan udelukkes en mulig årsagssammenhæng mellem fibrotiske reaktioner eller ergotisme og dihydroergocristin. 
• The Committee considered that a potential causal association between fibrotic reactions or ergotism and dihydroergocristine cannot be excluded.
Dette tyder på en årsagssammenhæng mellem fibrose og dihydroergocristin. 
This is indicative of a causal relationship between fibrosis and dihydroergocristine.
Endvidere skal det understreges, at sådanne bivirkninger er alvorlige, kan være dødelige og kan øge risikoen for, at patienten udvikler en fibrotisk lidelse ved langvarig brug i henhold til de godkendte indikationer. 
Moreover the severity of such adverse effects, their possible fatal outcome and the raised risk for patient to develop a fibrotic disorder with long term use according to the authorised indications should be underlined.
Samlet set kan den varierende affinitet for serotonerge receptorer med forskellige ergotderivater og de anvendte terapeutiske doser forklare de forskelle, der er observeret i forbindelse med indberetningsfrekvensen for fibrotiske reaktioner. 
Overall, the varying affinity for serotoninergic receptors with the different ergot derivatives and the therapeutic doses used may explain the differences observed for notification rates for the fibrotic reactions.
Selv om der er enighed om, at den medicinske terminologi, der anvendes i dag, adskiller sig fra tidligere anvendt terminologi, og at data skal vurderes med dette aspekt for øje, skyldes det kliniske symptom på demens forskellige patofysiologiske processer, der gør pooling og sammenligning af data vanskelig, især når de enkelte undersøgelser anvender forskellige inklusionskriterier. 
While it is agreed that the medical terminology used nowdays and in the past differs and that the data needs to be assessed bearing this aspect in mind, the clinical symptom of dementia is a result of various pathophysiological processes which makes pooling and comparison of the data difficult, especially when the individual studies used slightly different inclusion criteria.
− ikke er fordelagtigt til akut retinopati af vaskulær oprindelse. 
− Is not favourable for acute retinopathies of vascular origin.