FrancophonIA/ELRC3.0 huggingface dataset:
English: When Lyxumia is injected, lixisenatide reaches the receptors in the pancreas and activates them.
Danish: Når Lyxumia indsprøjtes, føres lixisenatid frem til receptorerne i bugspytkirtlen og aktiverer dem.
English: The most common side effects with Lyxumia (seen in more than 1 patient in 10) are nausea (feeling sick), vomiting, diarrhoea and headache.
Danish: De hyppigste bivirkninger ved Lyxumia (som optræder hos flere end 1 ud af 10 patienter) er kvalme, opkastning, diarré og hovedpine.
English: Lyxumia is started at a dose of 10 micrograms once a day which is increased to 20 micrograms once a day after 14 days.
Danish: Behandlingen med Lyxumia indledes med en dosis på 10 mikrogram én gang dagligt, som efter 14 dage øges til 20 mikrogram én gang dagligt.
English: Regarding its safety, most side effects are comparable to those of other similar diabetes medicines with side effects affecting the gut being the most common ones.
Danish: Hvad sikkerheden angår, svarer de fleste bivirkninger til bivirkningerne ved andre diabeteslægemidler, idet de hyppigste bivirkninger forekommer i tarmen.
English: It is used together with diabetes medicines taken by mouth and/or basal insulin (long-acting insulin) in patients whose blood glucose levels are not adequately controlled by these medicines together with diet and exercise.
Danish: Det anvendes sammen med diabeteslægemidler, der tages gennem munden, og/eller basalinsulin (langtidsvirkende insulin) hos patienter, hvis blodsukker ikke kan reguleres tilfredsstillende med de pågældende lægemidler sammen med diæt og motion.
English: For the full list of all side effects and restrictions with Lyxumia, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger og begrænsninger ved Lyxumia fremgår af indlægssedlen.
English: What is the risk associated with Lyxumia?
Danish: Hvilken risiko er der forbundet med Lyxumia?
English: The CHMP concluded that Lyxumia was shown to be effective at lowering blood glucose levels in patients with type 2 diabetes, when given alone or in combination with other diabetes medicines.
Danish: CHMP konkluderede, at Lyxumia havde vist sig effektivt til at sænke blodsukkeret ved type 2-diabetes, hvad enten det gives alene eller i kombination med andre diabeteslægemidler.
English: If the patient is already taking a sulphonylurea (another diabetes medicine) or basal insulin, the doctor may need to reduce the dose of the sulphonylurea or basal insulin because there is a risk of hypoglycaemia (low blood sugar levels).
Danish: Hvis patienten i forvejen får sulfonylurinstof (et andet diabeteslægemiddel) eller basalinsulin, kan det være nødvendigt at nedsætte dosis af sulfonylurinstof eller basalinsulin på grund af risikoen for lavt blodsukkerindhold (hypoglykæmi).
English: All of the studies measured the change in the level of glycosylated haemoglobin (HbA1c), which is the percentage of haemoglobin in the blood that has glucose attached.
Danish: I alle undersøgelserne måltes blodets indhold af glykosyleret hæmoglobin (HbA1c), dvs. den procentdel af blodets hæmoglobin, der er bundet til sukker (glukose).
English: The study comparing Lyxumia with exenatide (added to metformin) showed reduced HbA1c levels by 0.79% after 24 weeks treatment with Lyxumia compared to 0.96% with exenatide twice daily.
Danish: I den undersøgelse, hvor Lyxumia blev sammenlignet med exenatid (som tillægsbehandling til metformin), var HbA1c-niveauet faldet med 0,79 % efter 24-ugers behandling med Lyxumia, sammenlignet med 0,96 % med exenatid to gange dagligt.
English: Why has Lyxumia been approved?
Danish: Hvorfor blev Lyxumia godkendt?
English: In one study, Lyxumia was compared with another diabetes medicine called exenatide when added to metformin in patients whose blood sugar levels were not adequately controlled by metformin.
Danish: I én undersøgelse blev Lyxumia sammenlignet med diabeteslægemidlet exenatid som tillægsbehandling til metformin hos patienter, hos hvem blodsukkeret ikke kunne reguleres tilfredsstillende med metformin.
English: When used on its own, Lyxumia reduced Hb1Ac levels by 0.6% more than placebo.
Danish: Når Lyxumia blev anvendt alene, sænkede det Hb1Ac-niveauet 0,6 % mere end placebo.
English: This causes the release of insulin and helps to reduce blood glucose levels and control type 2 diabetes.
Danish: Dette medfører udskillelse af insulin og er medvirkende til at nedsætte blodsukkeret og regulere type 2-diabetes.
English: HbA1c levels were measured after 12 weeks when Lyxumia was used alone and after 24 weeks when it was used in combination with other diabetes medicines.
Danish: HbA1c er et mål for, hvor velreguleret blodsukkeret er. HbA1c-niveauet blev målt efter 12 uger, når Lyxumia blev anvendt alene, og efter 24 uger, når det blev anvendt i kombination med andre diabeteslægemidler.
English: It is given as an injection under the skin in the abdominal wall (at the front of the waist), upper arm or thigh.
Danish: Det gives ved en injektion under huden i maveskindet, overarmen eller låret.
English: Six of the studies compared Lyxumia with placebo (a dummy treatment), used alone or when added to metformin, a sulphonylurea, basal insulin, or a combination of two of these medicines, in patients in whom previous treatment had failed.
Danish: I seks af undersøgelserne blev Lyxumia sammenlignet med placebo (en virkningsløs behandling), enten anvendt alene eller som tillægsbehandling til metformin, et sulfonylurinstof, basalinsulin eller en kombination af to af disse lægemidler.
English: When used together with a sulphonylurea or basal insulin, the most common side effect (seen in more than 1 patient in 10) is hypoglycaemia (low blood glucose levels).
Danish: Når Lyxumia anvendes sammen med et sulfonylurinstof eller basalinsulin, er den hyppigste bivirkning (som optræder hos flere end 1 ud af 10 patienter) for lavt blodsukker (hypoglykæmi).
English: Type 2 diabetes is a disease in which the pancreas does not make enough insulin to control the level of glucose in the blood or when the body is unable to use insulin effectively.
Danish: Ved type 2-diabetes producerer bugspytkirtlen enten ikke nok insulin til at regulere blodsukkeret, eller også er kroppen ikke i stand til at udnytte insulinet tilstrækkeligt.
English: When used in combination with other diabetes medicines, Lyxumia reduced Hb1Ac levels by 0.4 up to 0.9% more than placebo.
Danish: Når Lyxumia blev anvendt i kombination med andre diabeteslægemidler, sænkede det Hb1Ac-niveauet med 0,4 - 0,9 % mere end placebo.
English: What is Lyxumia?
Danish: Hvad er Lyxumia?
English: Lyxumia is used in adults who have type 2 diabetes to control their blood glucose (sugar) level.
Danish: Lyxumia anvendes til regulering af blodsukkeret (glukose) hos voksne med type 2-diabetes.
English: How has Lyxumia been studied?
Danish: Hvordan blev Lyxumia undersøgt?
English: What benefit has Lyxumia shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Lyxumia?
English: What is Lyxumia used for?
Danish: Hvad anvendes Lyxumia til?
English: It works by attaching to glucagon-like peptide 1 (GLP-1) receptors that are found on the surface of the cells in the pancreas and that cause the production of insulin by the pancreas.
Danish: Disse receptorer findes på overfladen af cellerne i bugspytkirtlen og får bugspytkirtlen til at producere insulin.
English: How is Lyxumia used?
Danish: Hvordan anvendes Lyxumia?
English: How does Lyxumia work?
Danish: Hvordan virker Lyxumia?
English: Intravenous use Powder: vial (glass) Solvent: pre-filled syringe (glass)
Danish: 1 hætteglas + 1 fyldt injektionssprøjte + 1 stempelstang + 1 hætteglasadapter + 1 infusionssæt + 2 spritservietter + 2 plastre
English: QUALIGEN, SL
Danish: Spanien QUALIGEN, SL
English: Annex Ib: Products for which the marketing authorisations are recommended for suspension and marketing authorisation applications which do not satisfy the criteria for authorisation
Danish: Bilag IB: Lægemidler, hvis markedsføringstilladelser anbefales suspenderet, og ansøgninger om markedsføringstilladelser, som ikke imødekommer kriterierne for godkendelse
English: Annex Ia: Medicinal products recommended for maintenance and marketing authorisation applications for which bioequivalence vis-à-vis the EU reference medicinal product has been established
Danish: Bilag IA: Lægemidler, der anbefales opretholdt, og ansøgninger om markedsføringstilladelse, for hvilke bioækvivalens med EUreferencelægemidlet er blevet fastlagt
English: Sanofi Aventis France
Danish: Frankrig Sanofi Aventis France
English: ZYDUS France
Danish: Frankrig ZYDUS France
English: Hexal AG, Germany
Danish: Tyskland Hexal AG, Tyskland
English: Belgium Sandoz n.v./s.a.
Danish: Belgien Sandoz n.v./s.a.
English: perindopril / indapamide
Danish: perindopril/indapamid
English: tianeptine
Danish: tianeptin
English: Belfada aripiprazole
Danish: Belfada aripiprazol
English: Carbocisteine 375 mg Capsules, Hard carbocisteine
Danish: Carbocisteine 375 mg Capsules, Hard carbocistein
English: Prednisolon Alternova prednisolone
Danish: Prednisolon Alternova prednisolon
English: Bendro-flumetiazid Alternova bendro-flumethiazide 2.5 mg Tablet
Danish: Bendro-flumetiazid Alternova bendro-flumethiazid 2,5 mg Tablet
English: Loperamid Evolan loperamide
Danish: Loperamid Evolan loperamid
English: EG LABOLaboratoires Eurogenerics
Danish: Frankrig EG LABO - Laboratoires Eurogenerics
English: United Kingdom Lupin (Europe) Limited
Danish: Lupin (Europe) Limited
English: The Netherlands Sandoz B.V.
Danish: Nederlandene Sandoz B.V.
English: Corporation Orion Pharma, Finland
Danish: Finland Orion Corporation Orion Pharma, Finland
English: Loperamid Orifarm loperamide
Danish: Loperamid Orifarm loperamid
English: Sandoz A/S, Denmark
Danish: Finland Sandoz A/S, Denmark
English: LABORATORIOS COMBIX, SLU
Danish: Spanien LABORATORIOS COMBIX, SLU
English: United Kingdom Medreich PLC
Danish: Medreich PLC
English: United Kingdom Kinedexe UK Limited (previously
Danish: Kinedexe UK Limited (tidligere NRIM Limited)
English: SANDOZ FARMACEUTICA, SA
Danish: Spanien SANDOZ FARMACEUTICA, SA
English: Metoklopramid Alternova metoclopramide
Danish: Metoklopramid Alternova metoclopramid
English: Loperamid Apofri loperamide
Danish: Loperamid Apofri loperamid
English: Annex I List of medicinal products and presentations
Danish: Bilag I Liste over nationalt godkendte lægemidler
English: LABORATORIOS AUROBINDO, SLU
Danish: Spanien LABORATORIOS AUROBINDO, SLU
English: Morysa memantine
Danish: Morysa memantin
English: AUROVITAS SPAIN, SAU
Danish: Spanien AUROVITAS SPAIN, SAU
English: Amlodipina + Valsartan Aurovitas, Amlodipin/Valsartan PUREN (in Germany)
Danish: Amlodipina + Valsartan Aurovitas, Amlodipin/Valsartan PUREN (i Tyskland)
English: United Kingdom Dawa Limited
Danish: Dawa Limited
English: Memantine Pharmascope memantine
Danish: Memantine Pharmascope memantin
English: FarmozSociedade Técnico Medicinal, S.A.
Danish: Farmoz - Sociedade Técnico Medicinal, S.A.
English: dutasteride
Danish: dutasterid
English: Teva Sante
Danish: Frankrig Teva Sante
English: United Kingdom Milpharm Limited
Danish: Milpharm Limited
English: Sodium Cromoglicate 100mg hard Capsules sodium cromoglicate 100 mg Capsule, hard Oral use
Danish: Sodium Cromoglicate 100mg hard Capsules natriumcromoglicat
English: Arrow Génériques
Danish: Frankrig Arrow Génériques
English: ethinylestradiol / levonorgestrel
Danish: Ethinylestradiol/Levonorgeshel Famy Care
English: memantine
Danish: memantin
English: Mylan Dura GmbH
Danish: Tyskland Mylan Dura GmbH
English: United Kingdom Strides Arcolab International
Danish: Spanien Strides Arcolab International Limited
English: Omega 3-acid-ethyl esters 1000mg soft capsules omega-3-acid-ethyl esters 90
Danish: Omega 3-acid-ethyl esters 1000mg soft capsules omega-3-syre-ethylestere 90 1 000 mg Kapsel, blød Oral anvendelse
English: Medreich PLC Gliclazide 40 mg tablets gliclazide
Danish: Medreich PLC Gliclazide 40 mg tablets gliclazid
English: Belgium Aurobindo Pharma BV
Danish: Belgien Aurobindo Pharma BV
English: Atyxine hydroxyzine
Danish: Atyxine hydroxyzin
English: The Netherlands Pharmascope Ltd.
Danish: Nederlandene Pharmascope Ltd.
English: Aurobindo Pharma Ltd, Malta
Danish: Finland Aurobindo Pharma Ltd, Malta
English: Maexeni 30 0,03 mg/0,15 mg Filmtabletten ethinylestradiol / levonorgestrel mg/0.15 mg neuraxpharm Arzneimittel GmbH
Danish: Maexeni 30 0,03 mg/0,15 mg Filmtabletten ethinylestradiol/levonorgestrel 0,03 mg/0,15 mg
English: Gliclazide 80mg Tablets gliclazide
Danish: Gliclazide 80mg Tablets gliclazid
English: 1 A Pharma GmbH, Germany
Danish: Tyskland 1 A Pharma GmbH, Tyskland
English: Mylan SAS
Danish: Frankrig Mylan SAS
English: loperamide
Danish: loperamid
English: Gliclazide 40mg Tablets gliclazide
Danish: Gliclazide 40mg Tablets gliclazid
English: The Netherlands Aurobindo Pharma B.V.
Danish: Nederlandene Aurobindo Pharma B.V.
English: Hydroxyzine EQL Pharma hydroxyzine
Danish: Hydroxyzine EQL Pharma hydroxyzin
English: metformin hydrochloride
Danish: metforminhydrochlorid
English: Hydroxyzine ARROW hydroxyzine
Danish: Hydroxyzine ARROW hydroxyzin
English: 0.5 mg Capsule, soft Oral use
Danish: 0,5 mg Kapsel, blød Oral anvendelse
English: BBS Consult Aps Hydrokortison BBS
Danish: Hydrokortison BBS
English: Hydroxyzine hydrochloride 25mg film-coated tablets hydroxyzine hydrochloride
Danish: Hydroxyzine hydrochloride 25mg film-coated tablets hydroxyzinhydrochlorid 25 mg Filmovertrukket tablet
English: Hydroxyzinhydrochlorid EQL Pharma hydroxyzine
Danish: Hydroxyzinhydrochlorid EQL Pharma hydroxyzin
English: 300 mg Modified-release tablet
Danish: 300 mg Tablet med modificeret udløsning
English: Alternova A/S Hydrokortison Alternova hydrocortisone
Danish: Alternova A/S Hydrokortison Alternova hydrocortison 10 mg Tablet
English: hydroxyzine
Danish: hydroxyzin
English: Biogaran hydroxyzine BIOGARAN hydroxyzine
Danish: Frankrig Biogaran hydroxyzine BIOGARAN hydroxyzin
English: Metformine Almus metformin hydrochloride
Danish: Metformine Almus metforminhydrochlorid
English: Slovak Republic SVUS Pharma a.s.
Danish: Ungarn SVUS Pharma a.s.
English: Dawa Limited Carbimazole 5mg Tablets carbimazole
Danish: Dawa Limited Carbimazole 5mg Tablets carbimazol
English: Metformina Almus metformin hydrochloride
Danish: Metformina Almus metforminhydrochlorid
English: Hydroxyzine Sandoz hydroxyzine
Danish: Hydroxyzine Sandoz hydroxyzin
English: Levonorgestrel/Ethinylestradiol Famy Care 125 mikrogramů/30 mikrogramů ethinylestradiol / levonorgestrel
Danish: Levonorgestrel/Ethinylestradiol Famy Care 125 mikrogramů/30 mikrogramů ethinylestradiol/levonorgestrel 0,03 mg/0,125 mg
English: PUREN Pharma GmbH & Co. KG
Danish: Tyskland PUREN Pharma GmbH & Co.
English: Maexeni 150/30 microgram Film Coated Tablets ethinylestradiol / levonorgestrel
Danish: Maexeni 150/30 microgram Film Coated Tablets ethinylestradiol/levonorgestrel 0,03 mg/0,125 mg
English: Cristers
Danish: Frankrig Cristers
English: Hormosan Pharma GmbH
Danish: Tyskland Hormosan Pharma GmbH
English: Metformin 1000 mg Filmcoated tablet metformin hydrochloride
Danish: Metformin 1000 mg Filmcoated tablet metforminhydrochlorid
English: Carbimazole 5mg Tablets carbimazole
Danish: Carbimazole 5mg Tablets carbimazol
English: Metformin 850 mg Film-coated tablet metformin hydrochloride
Danish: Metformin 850 mg Film-coated tablet metforminhydrochlorid
English: 375 mg Capsule, hard Oral use
Danish: 375 mg Kapsel, hård Oral anvendelse
English: Corporation, Finland
Danish: Danmark Orion Corporation, Finland
English: Dawa Limited Carbimazole 20mg Tablets carbimazole
Danish: Dawa Limited Carbimazole 20mg Tablets carbimazol
English: Betahistin Sandoz 8 mg betahistine
Danish: Betahistin Sandoz 8 mg betahistin
English: Esters ethyliques d'acides omega-3 Strides omega-3-acid-ethyl esters 90
Danish: Esters ethyliques d'acides omega-3 Strides omega-3-syre-ethylestere 90 1 g Kapsel, blød Oral anvendelse
English: United Kingdom HEC Pharm GmbH
Danish: Tyskland HEC Pharm GmbH
English: Metformin 500 mg Film-coated tablet metformin hydrochloride
Danish: Metformin 500 mg Film-coated tablet metforminhydrochlorid
English: Paracetamol 1000 mg Film Coated Tablets paracetamol
Danish: Paracetamol 1000 mg Film Coated Tablets paracetamol mg
English: Memantine Dawa 20mg filmcoated tablets memantine
Danish: Memantine Dawa 20mg film-coated tablets memantin
English: Betahistin Sandoz 16 mg betahistine
Danish: Betahistin Sandoz 16 mg betahistin
English: Aripiprazole 30 mg tablets aripiprazole
Danish: Aripiprazole 30 mg tablets aripiprazol
English: Carbimazole 20 mg Tablets carbimazole
Danish: Carbimazole 20 mg Tablets carbimazol
English: Memantine Dawa 10mg filmcoated tablets memantine
Danish: Memantine Dawa 10mg film-coated tablets memantin
English: Oralcon 30 Microgramm/125 Microgramm Tabletten ethinylestradiol / levonorgestrel
Danish: Oralcon 30 Microgramm/125 Microgramm Tabletten ethinylestradiol/levonorgestrel 0,03 mg/0,125 mg
English: acide ursodesoxycholique Inopharm ursodeoxycholic acid 500 mg Film-coated tablet
Danish: acide ursodesoxycholique Inopharm ursodeoxycholinsyre
English: Beta- histina Bluefish betahistine dihydrochloride
Danish: Beta-histina Bluefish betahistindihydrochlorid 24 mg Tablet
English: Betahistine Sandoz 24 mg betahistine
Danish: Betahistine Sandoz 24 mg betahistin
English: Aripiprazole 5 mg tablets aripiprazole
Danish: Aripiprazole 5 mg tablets aripiprazol
English: 250 mg Capsule, hard Oral use
Danish: 250 mg Kapsel, hård Oral anvendelse
English: Aripiprazole 10 mg tablets aripiprazole
Danish: Aripiprazole 10 mg tablets aripiprazol
English: Carbimazole 20mg Tablets carbimazole
Danish: Carbimazole 20mg Tablets carbimazol
English: 150 mg Capsule, hard Oral use
Danish: 150 mg Kapsel, hård Oral anvendelse
English: Betahistin Sandoz 24 mg betahistine
Danish: Betahistin Sandoz 24 mg betahistin
English: 500 mg Capsule, hard Oral use
Danish: 500 mg Kapsel, hård Oral anvendelse
English: 1 g
Danish: KG
English: Memantine Pharmascope 20 mg filmomhulde tabletten memantine
Danish: Memantine Pharmascope 20 mg filmomhulde tabletten memantin
English: Memantine Pharmascope 10 mg filmomhulde tabletten memantine
Danish: Memantine Pharmascope 10 mg filmomhulde tabletten memantin
English: Memantin Pharmascope 20 mg Filmtabletten memantine
Danish: Memantin Pharmascope 20 mg Filmtabletten memantin
English: ZYDUS France perindopril/Indapamide Zydus France perindopril/indapamide 4 mg / 1.25 mg
Danish: Frankrig ZYDUS France perindopril/Indapamide Zydus France perindopril/indapamid
English: Memantin Pharmascope 10 mg Filmtabletten memantine
Danish: Memantin Pharmascope 10 mg Filmtabletten memantin
English: Aripiprazole 15 mg tablets aripiprazole
Danish: Aripiprazole 15 mg tablets aripiprazol
English: 0.03 mg / 0.125 mg
Danish: ethinylestradiol/levonorgestrel 0,03 mg/0,125 mg
English: Pharmaceuticals AB
Danish: Bluefish Pharmaceuticals AB
English: Arrow Génériques amlodipine / valsartan Arrow amlodipine / valsartan 5 mg/80 mg
Danish: Arrow Génériques amlodipine/valsartan Arrow amlodipin/ valsartan
English: Amlodipina/Valsartan Aurobindo 5 mg/80 mg comprimate filmate amlodipine / valsartan 5 mg /80 mg
Danish: Amlodipina/Valsartan Aurobindo 5 mg/80 mg comprimate filmate amlodipin/valsartan
English: Sandoz
Danish: Frankrig Sandoz
English: Amlodipine/ Valsartan Aurobindo 5/80 mg, filmomhulde tabletten amlodipine / valsartan 5 mg /80 mg
Danish: Amlodipine/ Valsartan Aurobindo 5/80 mg, filmomhulde tabletten amlodipin/valsartan
English: Amlodipine/ Valsartan Aurobindo 10/160 mg, filmomhulde tabletten amlodipine / valsartan 10 mg /160 mg
Danish: Amlodipine/ Valsartan Aurobindo 10/160 mg, filmomhulde tabletten amlodipin/valsartan
English: Amlodipina/Valsartan Aurobindo 10 mg/160 mg comprimate filmate amlodipine / valsartan 10 mg/160 mg
Danish: Amlodipina/Valsartan Aurobindo 10 mg/160 mg comprimate filmate amlodipin/valsartan
English: Proenzi s.r.o
Danish: Letland Proenzi s.r.o
English: Amlodipine/ Valsartan Aurobindo 5/160 mg, filmomhulde tabletten amlodipine / valsartan 5 mg /160 mg
Danish: Amlodipine/ Valsartan Aurobindo 5/160 mg, filmomhulde tabletten amlodipin/valsartan
English: BETAHISTIN SANDOZ 8 MG betahistine dihydrochloride
Danish: BETAHISTIN SANDOZ 8 MG betahistindihydrochlorid 8 mg Tablet
English: Amlodipina/Valsartan Aurobindo 5 mg/160 mg comprimate filmate amlodipine / valsartan 5 mg /160 mg
Danish: Amlodipina/Valsartan Aurobindo 5 mg/160 mg comprimate filmate amlodipin/valsartan
English: Betahistyna Bluefish betahistine dihydrochloride
Danish: Betahistyna Bluefish betahistindihydrochlorid 24 mg Tablet
English: 10 mg Oro-dispersible tablet
Danish: 10 mg Smeltetablet
English: BETAHISTIN SANDOZ 24 MG betahistine dihydrochloride
Danish: BETAHISTIN SANDOZ 24 MG betahistindihydrochlorid 24 mg Tablet
English: BETAHISTIN SANDOZ 16 MG betahistine dihydrochloride
Danish: BETAHISTIN SANDOZ 16 MG betahistindihydrochlorid 16 mg Tablet
English: Slovak Republic Proenzi s.r.o.
Danish: Litauen Proenzi s.r.o
English: 15 mg Oro-dispersible tablet
Danish: 15 mg Smeltetablet
English: 5 mg Oro-dispersible tablet
Danish: 5 mg Smeltetablet
English: Omega 3 Strides Arcolab International omega-3-acid-ethyl esters 90
Danish: Omega 3 Strides Arcolab International omega-3-syre-ethylestere 90 1 000 mg Kapsel, blød Oral anvendelse
English: Amlodipina + Valsartan Aurovitas amlodipine / valsartan 5 mg /80 mg
Danish: Amlodipina + Valsartan Aurovitas amlodipin/valsartan
English: Czech Republic Proenzi s.r.o.
Danish: Rumænien Proenzi s.r.o.
English: Strength Pharmaceutical Form
Danish: Styrke Lægemiddelfor m
English: Immediate Packaging
Danish: Administration Emballage
English: 0.8 ml (40 mg/0.8ml) 6 (3 x2) pre-filled pens (multipack)
Danish: 6 (3x2) fyldte penne (multipack)
English: 0.8 ml (40 mg/0.8ml) 6 (3 x2) pre-filled syringes with needle safety device (multipack)
Danish: 6 (3x2) fyldte injektionssprøjter med nålebeskyttelsesano rdning (multipack)
English: 0.8 ml (40 mg/0.8ml) 2 pre-filled syringes with needle safety device
Danish: 2 fyldte injektionssprøjter med nålebeskyttelsesano rdning
English: 21 March 2014
Danish: Den 21. marts 2014
English: The European Commission issued a decision on 21 March 2014.
Danish: Europa-Kommissionen traf en beslutning den 21. marts 2014.
English: What is Rocephin?
Danish: Hvad er Rocephin?
English: Rocephin is marketed in the following EU Member States: Belgium, Denmark, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Luxembourg, Malta, the Netherlands, Portugal, Romania, Sweden and the United Kingdom, as well as Iceland.
Danish: Rocephin markedsføres i følgende EU-medlemsstater: Belgien, Danmark, Finland, Frankrig, Tyskland, Grækenland, Ungarn, Irland, Italien, Letland, Luxembourg, Malta, Nederlandene, Portugal, Rumænien, Sverige, Det Forenede Kongerige samt Island.
English: Rocephin is authorised in the EU via national procedures.
Danish: Rocephin blev godkendt i EU via nationale procedurer.
English: The company that markets these medicines is Roche.
Danish: Den virksomhed, der markedsfører disse lægemidler, er Roche.
English: Why was Rocephin reviewed?
Danish: Hvorfor blev Rocephin vurderet igen?
English: This prevents the bacteria from building their cell walls, and eventually kills them.
Danish: Dette forhindrer bakterierne i at danne cellevægge, så de til sidst dør.
English: On 23 January 2014, the European Medicines Agency completed a review of Rocephin.
Danish: Den 23. januar 2014 afsluttede Det Europæiske Lægemiddelagentur en gennemgang af Rocephin.
English: The CHMP also harmonised other sections of the SmPC including section 4.3 (contraindications), 4.4 (special warnings and precautions for use) and 4.6 (pregnancy and lactation).
Danish: CHMP harmoniserede desuden andre afsnit af produktresuméet, herunder afsnit 4.3 (kontraindikationer), 4.4 (særlige advarsler og forsigtighedsregler vedrørende brugen) og 4.6 (graviditet og amning).
English: Rocephin is a medicine that contains the active substance ceftriaxone.
Danish: Rocephin er et lægemiddel, der indeholder det aktive stof ceftriaxon.
English: It is also available in the EU under other trade names: Rocefin, Rocephalin, Rocephalin cum lidocain, Rocephine.
Danish: Rocephin fås desuden i EU under andre handelsnavne: Rocefin, Rocephalin, Rocephalin cum lidocain, Rocephine.