FrancophonIA/ELRC3.0 huggingface dataset:
English: Bioequivalence has been demonstrated between Eucreas at three dose strengths (50 mg/500 mg, 50 mg/850 mg and 50 mg/1000 mg) versus free combination of vildagliptin and metformin hydrochloride tablets at the corresponding doses.
Danish: Bioækvivalens er påvist mellem Eucreas ved tre dosisstyrker (50 mg/500 mg, 50 mg/850 mg og 50 mg/1000 mg) i forhold til fri kombination af vildagliptin- og metforminhydrochloridtabletter ved de tilsvarende doser.
English: Eucreas combines two antihyperglycaemic agents with complimentary mechanisms of action to improve glycaemic control in patients with type 2 diabetes: vildagliptin, a member of the islet enhancer class, and metformin hydrochloride, a member of the biguanide class.
Danish: Eucreas kombinerer to antihyperglykæmiske midler med komplementære virkningsmekanismer for at forbedre den glykæmiske kontrol hos patienter med type 2-diabetes: vildagliptin, der tilhører klassen af ø-celle-forstærkere, og metformin-hydrochlorid, der tilhører klassen af biguanider.
English: Caution should be exercised in patients with a history of acute pancreatitis.
Danish: Forsigtighed skal udvises hos patienter med akut pankreatitis i anamnesen.
English: Eucreas may be initiated at either the 50 mg/850 mg or 50 mg/1000 mg tablet strength twice daily, one tablet in the morning and the other in the evening.
Danish: Behandling med Eucreas kan påbegyndes med én tablet på enten 50 mg/850 mg eller 50 mg/1000 mg to gange daglig, givet som en tablet om morgenen og en tablet om aftenen.
English: - Eucreas is indicated in triple combination therapy with insulin as an adjunct to diet and exercise to improve glycaemic control in adult patients when insulin at a stable dose and metformin alone do not provide adequate glycaemic control.
Danish: - Eucreas er indiceret som trippelbehandling med insulin som supplement til diæt og motion for at forbedre den glykæmiske kontrol hos voksne patienter, der ikke opnår tilstrækkelig glykæmisk kontrol med en stabil dosis insulin og metformin alene.
English: • Uncommon (may affect up to 1 in 100 people): joint pain, tiredness, constipation, swollen hands, ankle or feet (oedema).
Danish: • Ikke almindelige (kan forekomme hos op til 1 ud af 100 personer): ledsmerter, træthed, forstoppelse, hævede hænder, ankler eller fødder (ødem).
English: Eucreas 50 mg/1000 mg film-coated tablets are dark yellow, oval tablets with “NVR” on one side and “FLO” on the other.
Danish: Eucreas 50 mg/1000 mg filmovertrukne tabletter er mørkegule, ovale tabletter med ”NVR” på den ene side og ”FLO” på den anden.
English: Eucreas is available in packs containing 10, 30, 60, 120, 180 or 360 film-coated tablets and in multipacks containing 120 (2x60), 180 (3x60) or 360 (6x60) film-coated tablets.
Danish: Eucreas fås i pakninger med 10, 30, 60, 120, 180 eller 360 filmovertrukne tabletter og i multipakninger med 120 (2x60), 180 (3x60) eller 360 (6x60) filmovertrukne tabletter.
English: The dose of Eucreas should provide vildagliptin dosed as 50 mg twice daily (100 mg total daily dose) and a dose of metformin similar to the dose already being taken.
Danish: Eucreas bør gives som 50 mg vildagliptin to gange dagligt (i alt 100 mg dagligt) sammen med en dosis metformin svarende til den dosis, der allerede administreres.
English: If pancreatitis is suspected, vildagliptin should be discontinued; if acute pancreatitis is confirmed, vildagliptin should not be restarted.
Danish: Hvis der er mistanke om pankreatitis, bør vildagliptin seponeres.
English: What Eucreas looks like and contents of the pack Eucreas 50 mg/850 mg film-coated tablets are yellow, oval tablets with “NVR” on one side and “SEH” on the other.
Danish: Eucreas 50 mg/850 mg filmovertrukne tabletter er gule, ovale tabletter med ”NVR” på den ene side og ”SEH” på den anden.
English: Eucreas is not recommended for use in children and adolescents (< 18 years).
Danish: Eucreas bør ikke anvendes til børn og unge under 18 år.
English: After an oral dose of metformin, the maximum plasma concentration (Cmax) is achieved after about 2.5 h. Absolute bioavailability of a 500 mg metformin tablet is approximately 50-60% in healthy subjects.
Danish: Efter en oral dosis metformin nås den maksimale plasmakoncentration Cmax efter ca. 2,5 time.
English: Patients with hepatic impairment, including those with pre-treatment ALT or AST > 3x ULN, should not be treated with Eucreas (see sections 4.2, 4.3 and 4.8).
Danish: Patienter med nedsat leverfunktion bør ikke behandles med Eucreas, inklusive dem der før behandlingstidspunktet har ALAT eller ASAT > 3x ULN (se pkt.
English: - For patients switching from co-administration of vildagliptin and metformin as separate tablets: Eucreas should be initiated at the dose of vildagliptin and metformin already being taken.
Danish: - Patienter, der skifter fra samtidig administration af vildagliptin og metformin som separate tabletter:
English: Eucreas 50 mg/1000 mg film-coated tablets
Danish: Eucreas 50 mg/1000 mg filmovertrukne tabletter
English: - If you have any further questions, ask your doctor, pharmacist or nurse.
Danish: Er du i tvivl, så spørg lægen eller apoteketspersonalet.
English: Your doctor may want to reduce your dose of the sulphonylurea when you take it together with Eucreas in order to avoid low blood glucose (hypoglycaemia).
Danish: For at undgå, at du får lavt blodsukker [hypoglykæmi], vil din læge måske nedsætte din dosis af sulfonylurinstoffet, når du tager det sammen med Eucreas.
English: Eucreas 50 mg/850 mg film-coated tablets
Danish: Eucreas 50 mg/850 mg filmovertrukne tabletter
English: Eucreas 50 mg/850 mg film-coated tablets Eucreas 50 mg/1000 mg film-coated tablets
Danish: Eucreas 50 mg/850 mg filmovertrukne tabletter Eucreas 50 mg/1000 mg filmovertrukne tabletter
English: - Each Eucreas 50 mg/850 mg film-coated tablet contains 50 mg vildagliptin and 850 mg metformin hydrochloride (corresponding to 660 mg of metformin).
Danish: - Hver Eucreas 50 mg/850 mg filmovertrukket tablet indeholder 50 mg vildagliptin og 850 mg metforminhydrochlorid (svarende til 660 mg metformin).
English: How to take Eucreas
Danish: Sådan skal du tage Eucreas
English: If you take too many Eucreas tablets, or if someone else takes your tablets, talk to a doctor or pharmacist immediately.
Danish: Du skal straks kontakte en læge eller apoteket, hvis du har taget for mange Eucreas-tabletter, eller hvis en anden tager dine tabletter.
English: - Each Eucreas 50 mg/1000 mg film-coated tablet contains 50 mg vildagliptin and 1000 mg metformin hydrochloride (corresponding to 780 mg of metformin).
Danish: - Hver Eucreas 50 mg/1000 mg filmovertrukket tablet indeholder 50 mg vildagliptin og 1000 mg metforminhydrochlorid (svarende til 780 mg metformin).
English: What Eucreas is and what it is used for What you need to know before you take Eucreas How to take Eucreas
Danish: Det skal du vide, før du begynder at tage Eucreas Sådan skal du tage Eucreas Bivirkninger
English: Eucreas 50 mg/1000 mg film-coated tablets vildagliptin/metformin hydrochloride
Danish: Eucreas 50 mg/1000 mg filmovertrukne tabletter vildagliptin/metforminhydrochlorid
English: Eucreas 50 mg/850 mg film-coated tablets vildagliptin/metformin hydrochloride
Danish: Eucreas 50 mg/850 mg filmovertrukne tabletter vildagliptin/metforminhydrochlorid
English: Eucreas 50 mg/850 mg film-coated tablets Eucreas 50 mg/1000 mg film-coated tablets vildagliptin/metformin hydrochloride
Danish: Eucreas 50 mg/850 mg filmovertrukne tabletter Eucreas 50 mg/1000 mg filmovertrukne tabletter vildagliptin/metforminhydrochlorid
English: EU/1/07/425/007 10 film-coated tablets (PA/Alu/PVC/Alu) EU/1/07/425/008 30 film-coated tablets (PA/Alu/PVC/Alu) EU/1/07/425/009 60 film-coated tablets (PA/Alu/PVC/Alu) EU/1/07/425/010 120 film-coated tablets (PA/Alu/PVC/Alu) EU/1/07/425/011 180 film-coated tablets (PA/Alu/PVC/Alu) EU/1/07/425/012 360 film-coated tablets (PA/Alu/PVC/Alu) EU/1/07/425/025 10 film-coated tablets (PCTFE/PVC/Alu) EU/1/07/425/026 30 film-coated tablets (PCTFE/PVC/Alu) EU/1/07/425/027 60 film-coated tablets (PCTFE/PVC/Alu) EU/1/07/425/028 120 film-coated tablets (PCTFE/PVC/Alu) EU/1/07/425/029 180 film-coated tablets (PCTFE/PVC/Alu) EU/1/07/425/030 360 film-coated tablets (PCTFE/PVC/Alu)
Danish: EU/1/07/425/007 10 filmovertrukne tabletter (PA/Alu/PVC/Alu) EU/1/07/425/008 30 filmovertrukne tabletter (PA/Alu/PVC/Alu) EU/1/07/425/009 60 filmovertrukne tabletter (PA/Alu/PVC/Alu) EU/1/07/425/010 120 filmovertrukne tabletter (PA/Alu/PVC/Alu) EU/1/07/425/011 180 filmovertrukne tabletter (PA/Alu/PVC/Alu) EU/1/07/425/012 360 filmovertrukne tabletter (PA/Alu/PVC/Alu) EU/1/07/425/025 10 filmovertrukne tabletter (PCTFE/PVC/Alu) EU/1/07/425/026 30 filmovertrukne tabletter (PCTFE/PVC/Alu) EU/1/07/425/027 60 filmovertrukne tabletter (PCTFE/PVC/Alu) EU/1/07/425/028 120 filmovertrukne tabletter (PCTFE/PVC/Alu) EU/1/07/425/029 180 filmovertrukne tabletter (PCTFE/PVC/Alu) EU/1/07/425/030 360 filmovertrukne tabletter (PCTFE/PVC/Alu)
English: EU/1/07/425/016 120 film-coated tablets (PA/Alu/PVC/Alu) EU/1/07/425/017 180 film-coated tablets (PA/Alu/PVC/Alu) EU/1/07/425/018 360 film-coated tablets (PA/Alu/PVC/Alu) EU/1/07/425/034 120 film-coated tablets (PCTFE/PVC/Alu) EU/1/07/425/035 180 film-coated tablets (PCTFE/PVC/Alu) EU/1/07/425/036 360 film-coated tablets (PCTFE/PVC/Alu)
Danish: EU/1/07/425/016 120 filmovertrukne tabletter (PA/Alu/PVC/Alu) EU/1/07/425/017 180 filmovertrukne tabletter (PA/Alu/PVC/Alu) EU/1/07/425/018 360 filmovertrukne tabletter (PA/Alu/PVC/Alu) EU/1/07/425/034 120 filmovertrukne tabletter (PCTFE/PVC/Alu) EU/1/07/425/035 180 filmovertrukne tabletter (PCTFE/PVC/Alu) EU/1/07/425/036 360 filmovertrukne tabletter (PCTFE/PVC/Alu)
English: EU/1/07/425/001 10 film-coated tablets (PA/Alu/PVC/Alu) EU/1/07/425/002 30 film-coated tablets (PA/Alu/PVC/Alu) EU/1/07/425/003 60 film-coated tablets (PA/Alu/PVC/Alu) EU/1/07/425/004 120 film-coated tablets (PA/Alu/PVC/Alu) EU/1/07/425/005 180 film-coated tablets (PA/Alu/PVC/Alu) EU/1/07/425/006 360 film-coated tablets (PA/Alu/PVC/Alu) EU/1/07/425/019 10 film-coated tablets (PCTFE/PVC/Alu) EU/1/07/425/020 30 film-coated tablets (PCTFE/PVC/Alu) EU/1/07/425/021 60 film-coated tablets (PCTFE/PVC/Alu) EU/1/07/425/022 120 film-coated tablets (PCTFE/PVC/Alu) EU/1/07/425/023 180 film-coated tablets (PCTFE/PVC/Alu) EU/1/07/425/024 360 film-coated tablets (PCTFE/PVC/Alu)
Danish: EU/1/07/425/001 10 filmovertrukne tabletter (PA/Alu/PVC/Alu) EU/1/07/425/002 30 filmovertrukne tabletter (PA/Alu/PVC/Alu) EU/1/07/425/003 60 filmovertrukne tabletter (PA/Alu/PVC/Alu) EU/1/07/425/004 120 filmovertrukne tabletter (PA/Alu/PVC/Alu) EU/1/07/425/005 180 filmovertrukne tabletter (PA/Alu/PVC/Alu) EU/1/07/425/006 360 filmovertrukne tabletter (PA/Alu/PVC/Alu) EU/1/07/425/019 10 filmovertrukne tabletter (PCTFE/PVC/Alu) EU/1/07/425/020 30 filmovertrukne tabletter (PCTFE/PVC/Alu) EU/1/07/425/021 60 filmovertrukne tabletter (PCTFE/PVC/Alu) EU/1/07/425/022 120 filmovertrukne tabletter (PCTFE/PVC/Alu) EU/1/07/425/023 180 filmovertrukne tabletter (PCTFE/PVC/Alu) EU/1/07/425/024 360 filmovertrukne tabletter (PCTFE/PVC/Alu)
English: EU/1/07/425/013 120 film-coated tablets (PA/Alu/PVC/Alu) EU/1/07/425/014 180 film-coated tablets (PA/Alu/PVC/Alu) EU/1/07/425/015 360 film-coated tablets (PA/Alu/PVC/Alu) EU/1/07/425/031 120 film-coated tablets (PCTFE/PVC/Alu) EU/1/07/425/032 180 film-coated tablets (PCTFE/PVC/Alu) EU/1/07/425/033 360 film-coated tablets (PCTFE/PVC/Alu)
Danish: EU/1/07/425/013 120 filmovertrukne tabletter (PA/Alu/PVC/Alu) EU/1/07/425/014 180 filmovertrukne tabletter (PA/Alu/PVC/Alu) EU/1/07/425/015 360 filmovertrukne tabletter (PA/Alu/PVC/Alu) EU/1/07/425/031 120 filmovertrukne tabletter (PCTFE/PVC/Alu) EU/1/07/425/032 180 filmovertrukne tabletter (PCTFE/PVC/Alu) EU/1/07/425/033 360 filmovertrukne tabletter (PCTFE/PVC/Alu)
English: - For patients inadequately controlled at their maximal tolerated dose of metformin monotherapy: The starting dose of Eucreas should provide vildagliptin as 50 mg twice daily (100 mg total daily dose) plus the dose of metformin already being taken.
Danish: Startdosis af Eucreas bør gives som 50 mg vildagliptin to gange dagligt (i alt 100 mg dagligt) samt den dosis metformin, som allerede administreres.
English: The amount of Eucreas that people have to take varies depending on their condition.
Danish: Det afhænger af din sygdom, hvor mange Eucreastabletter du skal tage.
English: The marketing authorisation was renewed on 13 March 2002 and on 13 March 2007.
Danish: Markedsføringstilladelsen blev fornyet den 13. marts 2002 og den 13. marts 2007.
English: Other information about Refludan:
Danish: Andre oplysninger om Refludan:
English: The marketing authorisation holder is Celgene Europe Ltd.
Danish: Indehaveren af markedsføringstilladelsen er Celgene Europe Ltd.
English: Some patients can have a serious allergic shock when they receive Refludan for a second time.
Danish: Nogle patienter kan få et svært allergisk chok, når de får Refludan for anden gang.
English: The full EPAR for Refludan is available here.
Danish: Den fuldstændige EPAR for Refludan findes her.
English: The recommended dose is 0.4 mg per kilogram body weight as a single injection into a vein, followed by a continuous infusion at a dose of 0.15 mg/kg per hour for two to 10 days, or longer if needed.
Danish: Den anbefalede dosis er 0,4 mg pr. kg kropsvægt som en enkelt injektion i en vene efterfulgt af en kontinuerlig infusion i en dosis a 0,15 mg pr. kg kropsvægt pr. time i to til 10 dage eller længere om nødvendigt.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Refludan on 13 March 1997.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Refludan den 13. marts 1997.
English: It must not be used in patients who are pregnant or breast-feeding.
Danish: Det må ikke anvendes hos patienter, der er gravide eller ammer.
English: The Committee recommended that Refludan be given marketing authorisation.
Danish: Udvalget anbefalede udstedelse af markedsføringstilladelse for Refludan.
English: Bleeding leading to death occurs in around 1 patient in 100.
Danish: Blødning, der fører til død, optræder hos ca. 1 ud af 100 patienter.
English: It contains the active substance lepirudin.
Danish: Det indeholder det aktive stof lepirudin.
English: The studies did not compare Refludan with any other treatments, so the results were judged against historical controls (the results expected in untreated patients, based on past studies).
Danish: I undersøgelserne sammenlignede man ikke Refludan med andre behandlinger, så resultaterne blev bedømt i forhold til historiske kontroller (de resultater, der forventedes hos ubehandlede patienter på grundlag af tidligere tiders undersøgelser).
English: During the study period, 9% of the patients died (11 out of 125), 6% had amputations (7 out of 125) and 10% had new thromboembolic complications (12 out of 125).
Danish: I løbet af undersøgelsesperioden døde 9 % af patienterne (11 ud af 125), 6 % fik amputationer (7 ud af 125), og 10 % fik nye tromboemboliske komplikationer (12 ud af 125).
English: As the disease is very severe and there are no other effective treatments approved, the Committee for Medicinal Products for Human Use (CHMP) decided that Refludan's benefits are greater than its risks for the treatment of patients with HIT and thromboembolic disease.
Danish: Da sygdommen er meget alvorlig, og da der ikke foreligger andre godkendte behandlinger, besluttede Udvalget for Humanmedicinske Lægemidler (CHMP), at fordelene ved Refludan er større end risiciene ved behandling af patienter med HIT og tromboembolisk sygdom.
English: What is the risk associated with Refludan?
Danish: Hvilken risiko er der forbundet med Refludan?
English: EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) REFLUDAN EPAR summary for the public
Danish: EUROPÆISK OFFENTLIG VURDERINGSRAPPORT (EPAR) REFLUDAN EPAR - sammendrag for offentligheden
English: By blocking thrombin, Refludan greatly reduces the risk of blood clots forming, preventing subsequent damage.
Danish: Ved at blokere for trombin nedsætter Refludan kraftigt risikoen for dannelse af blodpropper, hvorved det forebygger efterfølgende skader.
English: Lepirudin is produced by a method known as ‘recombinant DNA technology': it is made by a cell that has received a gene (DNA), which makes it able to produce lepirudin.
Danish: Lepirudin produceres via en metode, der er kendt som ‘rekombinant DNA-teknologi': Det fremstilles af en celle, som har modtaget et gen (DNA), der sætter den i stand til at producere lepirudin.
English: The diagnosis must be confirmed using specific tests, such as the heparin-induced platelet aggregation assay (HIPAA) test.
Danish: Diagnosen skal bekræftes ved hjælp af bestemte tests såsom en HIPAA-test (heparin-induced platelet aggregation assay).
English: In the comparison with historical controls, the two trials taken together showed a significant benefit of Refludan on the rate of new thromboembolic complications and a trend towards increased survival.
Danish: I sammenligningen med de historiske kontroller viste de to undersøgelser taget under et en væsentlig fordel ved Refludan med hensyn til antallet af tromboemboliske komplikationer og en tendens til øget overlevelse.
English: Refludan is used to prevent blood clotting.
Danish: Refludan anvendes til forebyggelse af blodpropper.
English: Refludan has been studied in two main studies involving 198 patients, 125 of whom had HIT and thromboembolic disease.
Danish: Refludan blev undersøgt i to hovedundersøgelser, som omfattede 198 patienter, hvoraf 125 havde HIT og tromboembolisk sygdom.
English: The doses need to be reduced in patients with kidney problems.
Danish: Doserne skal være mindre for patienter med nyreproblemer.
English: As with other antithrombotic drugs, the most common side effect with Refludan (seen in more than 1 patient in 10) is bleeding.
Danish: Som med andre antitrombotiske lægemidler var den hyppigste bivirkning ved Refludan (som optræder hos flere end 1 ud af 10 patienter) blødning.
English: Its use is not advisable in patients who are bleeding or are at risk of bleeding because of a recent biopsy, stroke or major surgery, or because they are over the age of 65 years, among other reasons.
Danish: Det frarådes bl.a. til patienter, som bløder, eller som har risiko for at bløde på grund af en nylig biopsi, et slagtilfælde eller et større kirurgisk indgreb, eller fordi de er over 65 år.
English: It is used in adults with heparin-induced thrombocytopenia (HIT, a type of allergy to heparin that causes a lack of platelets in the blood or clots in the blood vessels) and who have thromboembolic disease (abnormal development of blood clots) that needs injected anti-clotting treatment, usually heparin.
Danish: Det anvendes til voksne med heparin-induceret trombocytopeni (HIT, en form for allergi over for heparin, som forårsager mangel på blodplader og/eller blodpropper i blodkarrene), og som har tromboembolisk sygdom (unormal udvikling af blodpropper), som kræver injiceret antitrombotisk behandling, sædvanligvis heparin.
English: Doctors should be very careful when re-exposing a patient to the medicine.
Danish: Lægen skal være meget forsigtig med at gentage brugen af lægemidlet hos samme patient.
English: Lepirudin specifically blocks a substance called thrombin, which is central for the complete process of blood clotting.
Danish: Lepirudin blokerer mere bestemt for et stof kaldet trombin, som er centralt for hele blodstørkningsprocessen.
English: Why has Refludan been approved?
Danish: Hvorfor blev Refludan godkendt?
English: The active substance in Refludan, lepirudin, is nearly identical to hirudin, the anti-clotting substance produced by leeches.
Danish: Det aktive stof i Refludan, lepirudin, er næsten identisk med hirudin, det antikoagulerende stof, der produceres af igler.
English: The studies looked at the numbers of patients who died, had an amputation, and had new thromboembolic (clotting) complications.
Danish: I undersøgelserne så man nærmere på antallene af patienter, som var døde, som havde fået en amputation, eller som havde nye tromboemboliske komplikationer (størkning).
English: Treatment with Refludan should be started by a doctor who has experience in the treatment of coagulation (clotting) disorders.
Danish: Behandling med Refludan bør indledes af en læge, som har erfaring i behandling af koagulationsforstyrrelser (størkning af blodet).
English: For the full list of all side effects reported with Refludan, see the Package Leaflet.
Danish: Den fuldstændige liste over alle de indberettede bivirkninger ved Refludan fremgår af indlægssedlen.
English: Refludan is a powder that is dissolved to make up a solution for injection or infusion (drip into a vein).
Danish: Refludan er et pulver, som opløses til en væske til injektion eller infusion (drop i en vene).
English: What benefit has Refludan shown during the studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Refludan?
English: Refludan should not be used in people who may be hypersensitive (allergic) to lepirudin, any other hirudin derivative, or any of the other ingredients.
Danish: Refludan må ikke anvendes af personer, der kan være overfølsomme (allergiske) over for lepirudin eller andre af indholdsstofferne.
English: Refludan is an antithrombotic medicine (a medicine that prevents the blood from clotting).
Danish: Refludan er et antitrombotisk lægemiddel (et lægemiddel, som forhindrer blodet i at størkne).
English: What is Refludan?
Danish: Hvad er Refludan?
English: What is Refludan used for?
Danish: Hvad anvendes Refludan til?
English: How has Refludan been studied?
Danish: Hvordan blev Refludan undersøgt?
English: See the Package Leaflet for the full list of restrictions.
Danish: Den fuldstændige liste over begrænsninger fremgår af indlægssedlen.
English: How is Refludan used?
Danish: Hvordan anvendes Refludan?
English: How does Refludan work?
Danish: Hvordan virker Refludan?
English: EU/1/99/097/001 Beromun
Danish: EU/1/99/097/00
English: Isolated limb perfusion (intra-arterial use)
Danish: Isoleret ekstremitetsperfusion (intraarteriel anvendelse)
English: Powder for solution for infusion
Danish: Beromun 1 mg Pulver til infusionsvæske, opløsning
English: Route of administration
Danish: Styrke Lægemiddelform Administration
English: vial (glass)
Danish: hætteglas (glas) 1 mg
English: MA (EU) number Invented name Strength Pharmaceutical form
Danish: MF (EU)nummer
English: Allergic reactions have been reported with these medicines.
Danish: Der er indberettet allergiske reaktioner i forbindelse med disse lægemidler.
English: Primula veris L. and/or Primula elatior (L.) Hill, flos
Danish: Primula veris L. og/eller Primula elatior (L.) Hill, flos
English: Primula flower EMA/423706/2016EMA/423706/2016
Danish: Primulablomst EMA/423706/2016
English: Primula flower medicines should only be used in adults and adolescents over the age of 12 years.
Danish: Lægemidler med primulablomst bør kun anvendes til voksne og børn over 12 år.
English: If symptoms last longer than one week or worsen during the use of the medicine, a doctor or a qualified
Danish: Hvis symptomerne varer længere end en uge eller forværres under brug af lægemidlet, bør der søges råd hos en læge
English: Primula flower is the common name for the flowers of the plant Primula veris L. and/or Primula elatior (L.) Hill.
Danish: Primulablomst er det almindelige navn for blomsterne af planten Primula veris L. og/eller Primula elatior (L.) Hill.
English: Any applications for the licensing of medicines containing primula flower have to be submitted to the national authorities responsible for medicinal products, which will assess the application for the herbal medicine and take into account the scientific conclusions of the HMPC.
Danish: Ansøgninger om godkendelse af lægemidler, der indeholder primulablomst, skal indsendes til de nationale lægemiddelmyndigheder, som vurderer ansøgningen om plantelægemidlet og tager hensyn til HMPC's videnskabelige konklusioner.