natgillin/translations-raw huggingface dataset:
Forhøjet blodtryk og forhøjet hjertefrekvens efter seponering af Intuniv Efter seponering af Intuniv kan blodtrykket og pulsen stige. 
Blood pressure and heart rate increase upon discontinuation of Intuniv Blood pressure and pulse may increase following discontinuation of Intuniv.
Kontakt lægen, hvis du er bekymret. 
If you are worried, speak to your doctor.
Hver 3 mg tablet indeholder 37,81 mg lactose (som monohydrat). 
Each 3 mg tablet contains 37.81 mg of lactose (as monohydrate).
• Tegn og symptomer på: o døsighed og sedation o hypotension o bradykardi 
o somnolence and sedation o hypotension o bradycardia
Forhøjet blodtryk og forhøjet hjertefrekvens efter seponering Efter seponering af Intuniv kan blodtrykket og pulsen stige. 
Blood pressure and heart rate increase upon discontinuation Blood pressure and pulse may increase following discontinuation of Intuniv.
CYP3A4- og CYP3A5-hæmmere 
CYP3A4 and CYP3A5 inhibitors
Moderate CYP3A4/5hæmmere 
Moderate CYP3A4/5 inhibitors
7 depottabletter 28 depottabletter 
7 prolonged-release tablets 28 prolonged-release tablets
Intuniv 3 mg tablet 7,94 mm runde, grønne tabletter præget med '3MG' på den ene side og med '503' på den anden side. 
Intuniv 3 mg tablet 7.94mm round, green tablets debossed with ‘3MG' on one side and ‘503' on the other side.
7 depottabletter 28 depottabletter 84 depottabletter 
7 prolonged-release tablets 28 prolonged-release tablets 84 prolonged-release tablets
• nedsat puls 
• reduced heart rate
• følelse af at være søvnig (døsighed) 
• feeling sleepy (somnolence)
Det anbefales, at en klinisk bedømmelse skal udføres i løbet af denne periode med efterfølgende overvågning hver 6. måned og hyppigere overvågning efter dosisjusteringer (se pkt. 
6 monthly monitoring should follow thereafter, with more frequent monitoring following any dose adjustments (see section 4.4).
Hver 4 mg tablet indeholder 50,42 mg lactose (som monohydrat). 
Each 4 mg tablet contains 50.42 mg of lactose (as monohydrate).
Virkningen af guanfacin ved behandling af ADHD er blevet undersøgt i 5 kontrollerede studier af børn og unge (i alderen 6-17 år), 3 kortvarige kontrollerede studier af børn og unge i alderen 6-17 år, 
The effects of guanfacine in the treatment of ADHD has been examined in 5 controlled studies in children and adolescents (6 to 17 years), 3 short-term controlled trials in children and adolescents aged 6 to 17 years, 1 short-term controlled study in adolescents aged 13 to 17 years, and 1 randomised withdrawal trial in children and adolescents aged 6-17 years, all of whom met the DSM-IV-TR criteria for ADHD.
28 depottabletter 84 depottabletter 
28 prolonged-release tablets 84 prolonged-release tablets
12,34 mm x 6,10 mm aflange, grønne tabletter præget med '4MG' på den ene side og med '503' på den anden side. 
12.34mm x 6.10mm oblong shaped, green tablets debossed with ‘4MG' on one side and ‘503' on the other side.
dosis=5 mg 
Dose= 5 mg
Se tabel 3 for en liste med eksempler på moderate og kraftige CYP3A4/5-hæmmere. 
Other CYP3A4/5 inhibitors may have a comparable effect, see table 3 for a list of examples of moderate and strong CYP3A4/5 inhibitors, this list is not definitive.
Nyrer og urinveje Enurese 
Renal and urinary disorders Enuresis
Intuniv 1 mg pakningsstørrelser: 7 eller 28 tabletter. 
Intuniv 1 mg pack sizes: 7 or 28 tablets.
• ufrivillig vandladning (enurese) 
• wetting yourself (enuresis)
Hver 2 mg tablet indeholder 44,82 mg lactose (som monohydrat). 
Each 2 mg tablet contains 44.82 mg of lactose (as monohydrate).
12,34 mm x 6,10 mm aflange, hvide til off-white tabletter præget med '2MG' på den ene side og med '503' på den anden side. 
12.34mm x 6.10mm oblong shaped, white to off-white tablets debossed with ‘2MG' on one side and “503” on the other side.
Det anbefales derfor, at patienterne overvåges nøje ugentligt i løbet af dosistitrering og -stabilisering (se pkt. 
It is therefore recommended that patients will be closely monitored weekly during dose titration and stabilisation (see section 4.2), and every 3 months during the first year, taking into consideration clinical judgement.
dosis=7 mg 
Dose= 7 mg
dosis=6 mg 
Dose= 6 mg
Intuniv indeholder: 
What Intuniv contains
dosis=4 mg 
Dose= 4 mg
Sådan skal du tage Intuniv 
How to take Intuniv
Sinus arytmi 
Sinus arrhythmia
Se tabel 3 for en liste med eksempler på CYP3A4/5-inducere. 
Other CYP3A4 inducers may have a comparable effect, see table 3 for a list of examples of CYP3A4/5 inducers, this list is not definitive.
Der bør udvises forsigtighed, når Intuniv administreres til patienter, der tager ketoconazol og andre moderate og kraftige CYP3A4/5-hæmmere. 
Caution should be used when Intuniv is administered to patients taking ketoconazole and other moderate and strong CYP3A4/5 inhibitors, a decrease in the dose of Intuniv within the recommended dose range is proposed (see section 4.2).
Det skal du vide, før du begynder at tage Intuniv Sådan skal du tage Intuniv Bivirkninger 
What Intuniv is and what it is used for What you need to know before you take Intuniv How to take Intuniv
Intuniv 2 mg pakningsstørrelser: 7, 28 eller 84 tabletter. 
Intuniv 2 mg pack sizes: 7, 28 or 84 tablets.
Størrelse af virkning 
Incidence Category
• pædagogisk behandling 
• educational therapy
Meget sjælden (kan forekomme hos op til 1 ud af 10.000 personer): 
Very rare: may affect up to 1 in 10,000 people
Lisdexamfetamindimesylat 
Lisdexamfetamine dimesylate
Den maksimale koncentration af guanfacin (Cmax) og eksponeringen (AUC) var hhv. 2 og 3 gange forhøjet. 
There was a substantial increase in the rate and extent of guanfacine exposure when administered with ketoconazole; the guanfacine peak plasma concentrations (Cmax) and exposure (AUC) increased 2- and 3-fold, respectively.
Behandlin gs-grupper 
Treatment groups
• 1 mg depottabletter er runde og hvide, hårde tabletter, præget med 1MG på den ene side og med 503 på den anden side. 
• The 1 mg prolonged-release tablets are round and white, hard tablets, debossed with 1MG on one side and 503 on the other side.
EU/1/15/1040/003 7 depottabletter EU/1/15/1040/004 28 depottabletter EU/1/15/1040/005 84 depottabletter 
EU/1/15/1040/003 7 prolonged-release tablets EU/1/15/1040/004 28 prolonged-release tablets EU/1/15/1040/005 84 prolonged-release tablets
Intuniv 4 mg pakningsstørrelser: 28 eller 84 tabletter. 
Intuniv 4 mg pack sizes: 28 or 84 tablets.
• 2 mg depottabletter er ovale og hvide, hårde tabletter, præget med 2MG på den ene side og med 503 på den anden side. 
• The 2 mg prolonged-release tablets are oval and white, hard tablets, debossed with 2MG on one side and 503 on the other side.
Intuniv 3 mg pakningsstørrelser: 28 eller 84 tabletter. 
Intuniv 3 mg pack sizes: 28 or 84 tablets.
• 3 mg depottabletter er runde og grønne, hårde tabletter, præget med 3MG på den ene side og med 503 på den anden side. 
• The 3 mg prolonged-release tablets are round and green, hard tablets, debossed with 3MG on one side and 503 on the other side.
• Hver 1 mg tablet indeholder guanfacinhydrochlorid svarende til 1 mg guanfacin 
• Each 1 mg tablet contains guanfacine hydrochloride equivalent to 1 mg of guanfacine
• 4 mg depottabletter er ovale og grønne, hårde tabletter, præget med 4MG på den ene side og med 503 på den anden side. 
• The 4 mg prolonged-release tablets are oval and green, hard tablets, debossed with 4MG on one side and 503 on the other side.
EU/1/15/1040/001 7 depottabletter EU/1/15/1040/002 28 depottabletter 
EU/1/15/1040/001 7 prolonged-release tablets EU/1/15/1040/002 28 prolonged-release tablets
Intuniv 1 mg tablet Hver tablet indeholder guanfacinhydrochlorid svarende til 1 mg guanfacin. 
Intuniv 1 mg tablet Each tablet contains guanfacine hydrochloride equivalent to 1 mg of guanfacine.
• Hver 4 mg tablet indeholder guanfacinhydrochlorid svarende til 4 mg guanfacin 
• Each 4 mg tablet contains guanfacine hydrochloride equivalent to 4 mg of guanfacine
EU/1/15/1040/008 28 depottabletter EU/1/15/1040/009 84 depottabletter 
EU/1/15/1040/008 28 prolonged-release tablets EU/1/15/1040/009 84 prolonged-release tablets
• Hver 2 mg tablet indeholder guanfacinhydrochlorid svarende til 2 mg guanfacin 
• Each 2 mg tablet contains guanfacine hydrochloride equivalent to 2 mg of guanfacine
Intuniv 4 mg tablet Hver tablet indeholder guanfacinhydrochlorid svarende til 4 mg guanfacin. 
Intuniv 4 mg tablet Each tablet contains guanfacine hydrochloride equivalent to 4 mg of guanfacine.
Intuniv 2 mg tablet Hver tablet indeholder guanfacinhydrochlorid svarende til 2 mg guanfacin. 
Intuniv 2 mg tablet Each tablet contains guanfacine hydrochloride equivalent to 2 mg of guanfacine.
Hver tablet indeholder guanfacinhydrochlorid svarende til 1 mg guanfacin. 
Each tablet contains guanfacine hydrochloride equivalent to 1 mg of guanfacine.
• Hver 3 mg tablet indeholder guanfacinhydrochlorid svarende til 3 mg guanfacin 
• Each 3 mg tablet contains guanfacine hydrochloride equivalent to 3 mg of guanfacine
Intuniv 2 mg depottabletter Guanfacin 
Intuniv 2 mg prolonged-release tablets Guanfacine
Intuniv 3 mg tablet Hver tablet indeholder guanfacinhydrochlorid svarende til 3 mg guanfacin. 
Intuniv 3 mg tablet Each tablet contains guanfacine hydrochloride equivalent to 3 mg of guanfacine.
Kontakt lægen eller apotekspersonalet, før du tager dette lægemiddel, hvis lægen har fortalt dig, at du ikke kan tåle eller fordøje visse sukkerarter. 
If you have been told by your doctor that you cannot tolerate or digest some sugars, talk to your doctor or pharmacist before taking this medicine.
EU/1/15/1040/006 28 depottabletter EU/1/15/1040/007 84 depottabletter 
EU/1/15/1040/006 28 prolonged-release tablets EU/1/15/1040/007 84 prolonged-release tablets
Hver tablet indeholder guanfacinhydrochlorid svarende til 4 mg guanfacin. 
Each tablet contains guanfacine hydrochloride equivalent to 4 mg of guanfacine.
Intuniv 1 mg depottabletter Guanfacin 
Intuniv 1 mg prolonged-release tablets Guanfacine
Intuniv 4 mg depottabletter Guanfacin 
Intuniv 4 mg prolonged-release tablets Guanfacine
Nedsat puls 
Heart rate decreased
• svaghedsfølelse (asteni) 
• feeling weak (asthenia)
Intuniv 3 mg depottabletter Guanfacin 
Intuniv 3 mg prolonged-release tablets Guanfacine
Almene symptomer Træthed 
General disorders Fatigue
Hver tablet indeholder guanfacinhydrochlorid svarende til 2 mg guanfacin. 
Each tablet contains guanfacine hydrochloride equivalent to 2 mg of guanfacine.
Hver tablet indeholder guanfacinhydrochlorid svarende til 3 mg guanfacin. 
Each tablet contains guanfacine hydrochloride equivalent to 3 mg of guanfacine.
Intuniv 3 mg depottabletter 
Intuniv 3 mg prolonged-release tablets
Hvis du har taget for meget Intuniv 
If you take more Intuniv than you should
• social behandling 
• social therapy
Intuniv 4 mg depottabletter 
Intuniv 4 mg prolonged-release tablets
Intuniv 2 mg depottabletter 
Intuniv 2 mg prolonged-release tablets
Respondenter 
Excipients
Affektlabilitet 
Affect lability
Intuniv 1 mg depottabletter 
Intuniv 1 mg prolonged-release tablets
Perikon 
Pallor
• Produktresumé og indlægsseddel 
• Summary of Product Characteristics (SmPC) and Package Leaflet
Hvad er colistin? 
What is colistin?
14. juli 2016 
14 July 2016
Disse anvisninger gennemgik kritiske oplysninger om 
This advice critically reviewed information on
Europa-Kommissionen traf en afgørelse den 14. juli 2016. 
The European Commission issued a decision on 14 July 2016.
Colistin anvendes til behandling og forebyggelse af sygdomme, der skyldes følsomme bakterier (f.eks. Escherichia coli) hos svin, fjerkræ, kaniner, kvæg, får og geder. 
Colistin is used for the treatment and prevention of diseases caused by sensitive bacteria (e.g. Escherichia coli) in pigs, poultry, rabbits, cattle, sheep and goats.
Resultatet af en indbringelsesprocedure i henhold til artikel 35 i direktiv 2001/82/EF (EMEA/V/A/111) 
Outcome of a referral procedure under Article 35 of Directive 2001/82/EC (EMEA/V/A/111)
2 om at begrænse indikationerne, måldyrearterne og behandlingsvarigheden for de pågældende produkter og tilføje advarsler om forsvarlig brug i produktinformationen. 
2 restricting the indications, target species, and duration of treatment of the concerned products, as well as adding prudent use warnings to the product information.
anvendelsen af colistin hos fødevareproducerende dyr i EU, dets effekt på udviklingen af resistens over for denne kategori af antimikrobielle stoffer hos bakteriearter, der er vigtige for menneskers og dyrs sundhed, og den mulige indvirkning heraf på menneskers og dyrs sundhed. 
the use of colistin in food-producing animals in the EU, its effect on the development of resistance to this category of antimicrobial agents in bacterial species that are of importance for human and animal health and the possible impact on human and animal health.
Colistin tilhører den gruppe antibiotika, der kaldes polymyxiner. 
Colistin belongs to the polymyxin group of antibiotics.
CVMP blev anmodet om at gennemgå markedsføringstilladelserne og de tilgængelige data for at sikre ansvarlig anvendelse af stoffet med henblik på at beskytte dyrs sundhed og begrænse muligheden for en fremtidig risiko for folkesundheden. 
The CVMP was requested to review the marketing authorisations and the available data in order to ensure responsible use of the substance in protecting animal health and limiting the possibility of future risk to public health.
Der er tale om veterinærlægemidler, der indeholder colistin kombineret med 14 forskellige antimikrobielle stoffer fra forskellige klasser, f.eks. β-laktamer, tetracykliner, makrolider, sulfonamider og trimethoprim (se bilag I under fanebladet "All documents"). 
These include veterinary medicinal products containing combinations of colistin with 14 different antimicrobial substances, belonging to different classes e.g. β-lactams, tetracyclines, macrolides, sulfonamides and trimethoprim (see Annex I on the 'All documents' tab).
Colistin kombineret med andre antimikrobielle stoffer fås til gruppebehandling af gastrointestinale og respiratoriske infektioner hos fødevareproducerende dyr i forskellige EU-medlemsstater. 
Combinations of colistin with other antimicrobials are available for group treatments of gastro-intestinal and respiratory infections in food-producing animals in different European Member States.
Spørgsmål og svar vedrørende veterinærlægemidler, der indeholder colistin i kombination med andre antimikrobielle stoffer til oral administration EMA/461505/2016 
Questions and answers on veterinary medicinal products containing colistin in combination with other antimicrobial substances to be administered orally EMA/461505/2016
EMA's Udvalg for Lægemidler til Dyr (CVMP) har konkluderet, at det generelle benefit/risk-forhold for de nævnte veterinærlægemidler er negativt, dels som følge af den manglende kliniske relevans, dels på baggrund af, at overeksponering for colistin kan udgøre en potentiel risiko for dyrs og menneskers sundhed ved at fremskynde forekomsten af resistens mod colistin. 
The Agency's Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the overall benefit-risk balance for the aforementioned products is negative, due to a lack of clinical relevance and in view of over-exposure of colistin that could pose a potential risk to animal and human health from an acceleration of the occurrence of colistin resistance.
Desuden blev markedsføringstilladelsesindehaverne anmodet om at godtgøre fordelene ved at bruge kombinationsprodukter, der indeholder colistin, i forhold til monoterapi til behandling af de respektive sygdomme, navnlig under hensyntagen til CVMP's retningslinjer for kombinationspræparater 
In addition, the marketing authorisation holders were asked to justify the benefits of using a colistin combination product over the use of monotherapy for the treatment of the respective conditions, particularly taking into account the CVMP guideline on pharmaceutical fixed combination products
Efter vurdering af de foreliggende data konkluderede CVMP, at der ikke kan påvises nogen fordele ved anvendelse af colistin kombineret med andre stoffer i forhold til monoterapi, og at der ikke kan fastsættes nogen egnede risikominimeringsforanstaltninger til imødegåelse af den identificerede potentielle risiko for menneskers sundhed, da selv begrænset anvendelse af colistin kombineret med andre stoffer anses for unødvendig. 
Based on the evaluation of the currently available data, the CVMP concluded that no benefit could be demonstrated when using colistin combination products instead of monotherapy and no feasible risk mitigation measures could be identified to address the identified potential risk for human health, as even limited use of colistin combination products was considered unnecessary.
Spørgsmål og svar vedrørende veterinærlægemidler, der indeholder colistin i kombination med andre antimikrobielle stoffer til oral administration 
Questions and answers on veterinary medicinal products containing colistin in combination with other antimicrobial substances to be administered orally
Kommissionenes beslutning om markedsføringstilladelse i henhold til artikel 35 i Europa Parlamentets og Rådets direktiv 2001/82/EF for alle veterinærlægemidler, som indeholder "Colistin" til oral administration ((2015)1916 of 16/03/2015) http://ec.europa.eu/health/documents/community-register/html/vo25478.htm 
Commission Decision concerning, in the framework of Article 35 of Directive 2001/82/EC of the European Parliament and of the Council, the marketing authorisations for all veterinary medicinal products containing "Colistin" to be administered orally ((2015)1916 of 16/03/2015) http://ec.europa.eu/health/documents/community-register/html/vo25478.htm
Den 21. april 2016 afsluttede Det Europæiske Lægemiddelagentur (EMA) en undersøgelse af virkning og antimikrobiel resistens, hvad angår alle veterinærlægemidler, der indeholder colistin i kombination med andre antimikrobielle stoffer til oral administration. 
On 21 April 2016, the European Medicines Agency (the Agency) completed a review of the effectiveness of and antimicrobial resistance to all veterinary medicinal products containing colistin in combination with other antimicrobial substances to be administered orally.
Hvorfor blev veterinærlægemidler, der indeholder colistin i kombination med andre antimikrobielle stoffer til oral administration, undersøgt? 
Why were veterinary medicinal products containing colistin in combination with other antimicrobial substances reviewed?
CVMP anbefalede, at alle markedsføringstilladelser for veterinærlægemidler, der indeholder colistin i kombination med andre antimikrobielle stoffer til oral administration, inddrages i hele Den Europæiske Union (EU). 
The CVMP recommended that all marketing authorisations for veterinary medicinal products containing colistin in combination with other antimicrobial substances to be administered orally should be withdrawn throughout the European Union (EU).
CVMP anbefalede derfor, at alle markedsføringstilladelser for alle veterinærlægemidler, der indeholder colistin i kombination med andre antimikrobielle stoffer til oral administration, inddrages. 
Therefore the CVMP recommended that all marketing authorisations for all veterinary medicinal products containing colistin in combination with other antimicrobial substances to be administered orally should be withdrawn.
I maj 2015 indledte Europa-Kommissionen en indbringelsesprocedure i medfør af artikel 35 i direktiv 2001/82/EF for alle veterinærlægemidler, der indeholder colistin i kombination med andre antimikrobielle stoffer til oral administration. 
On 4 May 2015, the European Commission initiated a referral procedure under Article 35 of Directive 2001/82/EC for all veterinary medicinal products containing colistin in combination with other antimicrobial substances to be administered orally.
London, den 13. april 2007 EMEA/CHMP/75285/2007 
London, 13 April 2007 EMEA/CHMP/75285/2007
Den endelige udtalelse blev konverteret til en afgørelse truffet af Europa-Kommissionen den 13. april 2007. 
The final opinion was converted into a Decision by the European Commission on 13 April 2007.
Voldgiftsproceduren indledtes den 27. juli 2006 med vedtagelsen af liste med spørgsmål. 
The arbitration procedure started on 27 July 2006 with the adoption of a list of questions.
Der er påvist et fald i forekomsten af vertebrale frakturer, men ikke i forekomsten af ikke-vertebrale frakturer”. 
A reduction in the incidence of vertebral, but not of non-vertebral fractures has been demonstrated”.
Sverige fremsendte begrundelserne for uenigheden til EMEA den 10. juli 2006. 
Sweden referred the reasons for disagreement to the EMEA on 10 July 2006.
Indehaveren af markedsføringstilladelsen fremsendte skriftlige redegørelser den 19. oktober 2006. 
The Marketing Authorisation Holder provided written explanations on 19 October 2006.
Der blev konstateret betydelige forskelle med hensyn til indikationen til behandling af osteoporose hos mænd, og dette blev anset for at udgøre et alvorligt problem for folkesundheden. 
Significant difference has been identified with regard to the indication for treatment of osteoporosis in men and this was considered to be of serious public health concern.
Rapportøren var Dr. Tomas Salmonson, og medrapportøren var Dr. Frits Lekkerkerker. 
The Rapporteur was Dr. Tomas Salmonson and Co-Rapporteur(s) was Dr. Frits Lekkerkerker.
Ansøgningen blev ved gentagen anvendelse af den gensidige anerkendelsesprocedure, som blev indledt den 11. oktober 2005, indgivet til følgende berørte medlemsstater (CMS): Belgien, Grækenland og Danmark. 
In the repeat use of the Mutual Recognition procedure, which started on 11 October 2005, the application was submitted to the Concerned Member States (CMS): Belgium, Greece and Denmark.
CHMP var af den opfattelse, at benefit/risk-forholdet var gunstigt for følgende indikation: “Behandling af osteoporose hos mænd med forhøjet risiko for brud. 
The CHMP considered that the benefit/risk ratio was considered to be favourable in the following indication: “Treatment of osteoporosis in men at increased risk of fracture.
Referencemedlemsstaten var Sverige, og i den første fase af den gensidige anerkendelsesprocedure var de berørte medlemsstater, som allerede havde udstedt markedsføringstilladelse, Tyskland og Polen. 
The Reference Member State was Sweden and in the first wave of the mutual recognition procedure, the concerned Member States which have already granted the marketing authorisation were Germany and Poland.
På sit møde i januar 2007 var CHMP på grundlag af de samlede forelagte oplysninger og den faglige drøftelse i udvalget af den opfattelse, at de indsigelser, der havde givet anledning til artikel 29-indbringelsen, ikke bør være til hinder for udstedelse af en markedsføringstilladelse for Alendronat HEXAL og tilknyttede navne. 
During their January 2007 meeting, the CHMP, in the light of the overall data submitted and the scientific discussion within the Committee, was of the opinion that the objections that triggered the Article 29 Referral, should not prevent the granting of a Marketing Authorisation for Alendronate HEXAL and associated names.
Hexal A/S indgav ansøgninger om gensidig anerkendelse af Alendronat HEXAL og tilhørende navne, 10 mg tabletter, på baggrund af den markedsføringstilladelse, Sverige havde udstedt den 3. december 2004. 
Hexal A/S submitted applications for mutual recognition of Alendronate HEXAL and associated names, 10 mg tablets on the basis of the marketing authorisation granted by Sweden on 3 December 2004.
Den 24. januar 2007 vedtog CHMP en positiv udtalelse, som anbefalede udstedelse af markedsføringstilladelsen og ændring af referencemedlemsstatens produktresumé, etikettering og indlægsseddel. 
Therefore the CHMP issued a positive opinion on 24 January 2007 recommending the granting of the Marketing Authorisation and the amendments of the Summary of Product Characteristics, labelling and package leaflet of the Reference Member State.