FrancophonIA/ELRC3.0 huggingface dataset:
English: - if you are allergic to sucroferric oxyhydroxide or any of the other ingredients of this medicine
Danish: - hvis du er allergisk over for sucroferrioxyhydroxid eller et af de øvrige indholdsstoffer i dette lægemiddel (angivet i punkt 6).
English: What Velphoro contains
Danish: Velphoro indeholder
English: Velphoro contains starches.
Danish: Velphoro indeholder stivelse.
English: Abdominal distension Gastritis Abdominal discomfort Dysphagia Gastro-oesophageal reflux disease (GORD) Tongue discolouration
Danish: Abdominal udspiling Gastritis Abdominal ubehag Dysfagi Gastroøsofageal reflukssygdom (GORD) Misfarvning af tungen
English: Treatment of patient sub-populations from week 24 to week 27 with maintenance dose of Velphoro (1,000 to 3,000 mg iron/day) or low dose (250 mg iron/day) of Velphoro demonstrated superiority of the maintenance dose.
Danish: Behandlingen af patienter i underpopulationen fra uge 24 til uge 27 med vedligeholdelsesdosis af Velphoro (1.000 til 3.000 mg jern/dag) eller lav dosis (250 mg jern/dag) af Velphoro påviste overlegenhed i forhold til vedligeholdelsesdosen.
English: Corresponding levels for sevelamer carbonate at baseline were 2.4 mmol/L and 1.7 mmol/L at week 12 (reduction by 0.7 mmol/L), respectively.
Danish: Tilsvarende niveauer for sevelamer-carbonat ved baseline var henholdsvis 2,4 mmol/l og 1,7 mmol/l ved uge 12 (fald på 0,7 mmol/l).
English: Common (may affect up to 1 in 10 people): feeling sick (nausea), constipation, vomiting, indigestion, pain in stomach and gut, gas, tooth discolouration, change in taste.
Danish: Almindelig (forekommer hos op til 1 ud af 10 personer): utilpashed (kvalme), forstoppelse, opkastning, fordøjelsesbesvær, mavesmerter, luft i maven, misfarvning af tænder, ændret smagssans.
English: If you are breastfeeding, your doctor will discuss with you whether to continue breastfeeding or to continue therapy with Velphoro, taking into account the benefit of Velphoro therapy to you and the benefit of breastfeeding to your child.
Danish: Hvis du ammer, vil lægen tale med dig om, hvorvidt du bør fortsætte med at amme eller fortsætte behandlingen med Velphoro i lyset af fordelene for dig ved behandling med Velphoro og fordelene ved amning for dit barn.
English: Velphoro is for oral administration only and must be taken with meals.
Danish: Velphoro er kun til oral anvendelse og skal tages i forbindelse med måltider.
English: If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before taking this medicine.
Danish: Hvis du er i tvivl, om det ovenstående gælder for dig, skal du kontakte din læge eller apotekspersonalet, før du tager dette lægemiddel.
English: Velphoro is a chewable tablet that must be taken with meals.
Danish: Velphoro er en tyggetablet, der skal tages i forbindelse med måltider.
English: Patients with diabetes should take notice that one tablet of Velphoro is equivalent to approximately 1.4 g of carbohydrates (equivalent to 0.116 bread units).
Danish: Patienter med diabetes skal være opmærksomme på, at én Velphoro-tablet svarer til cirka 1,4 g kulhydrater (svarende til 0,116 brødenheder).
English: Patients receiving Velphoro should adhere to their prescribed diets.
Danish: Patienter, der får Velphoro, skal følge den ordinerede kostplan.
English: The tablets are packed in high density polyethylene bottles with a child resistant polypropylene closure and a foil induction seal, or in child resistant aluminium blister.
Danish: Tabletterne er pakket i højdensitetspolyethylenflasker med en børnesikret polypropylenlukning og folieforsegling eller i børnesikrede blisterkort af aluminium.
English: However, the degradation product of Velphoro, mononuclear iron species, can be released from the surface of polynuclear iron(III)oxyhydroxide and be absorbed.
Danish: Degraderingsproduktet af Velphoro, mononukleære jernarter, kan dog frigives fra overfladen af polynukleært jern(III)-oxyhydroxid og absorberes.
English: The maximum recommended dose is 3,000 mg iron (6 tablets) per day.
Danish: Den maksimale anbefalede dosis er 3.000 mg jern dagligt (6 tabletter).
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER OF 6 CHEWABLE TABLETS
Danish: MINDSTEKRAV TIL MÆRKNING PÅ BLISTERKORT ELLER BLISTERTRIPS BLISTER MED 6 TYGGETABLETTER
English: - The other ingredients are woodberry flavour, neohesperidin-dihydrochalcone, magnesium stearate, colloidal anhydrous silica.
Danish: - Øvrige indholdsstoffer: skovbærsmag, neohesperidin-dihydrochalcon, magnesiumstearat, kolloid, vandfri silica.
English: Adult patients with hyperphosphataemia (serum phosphorus levels ≥1.94 mmol/L) were treated with Velphoro at a starting dose of 1,000 mg iron/day followed by an 8-week dose titration period.
Danish: Voksne patienter med hyperfosfatæmi (serumfosfatniveauer ≥ 1,94 mmol/l) blev behandlet med Velphoro med en startdosis på 1.000 mg jern/dag efterfulgt af en dosistitreringsperiode på 8 uger.
English: Diarrhoea* Faeces discoloured
Danish: Diarré* Misfarvet afføring
English: Method of administration - Velphoro should only be taken by mouth.
Danish: Indtagelse - Velphoro skal indtages gennem munden.
English: Following completion of Study-05A, 658 patients (597 on hemodialysis and 61 on peritoneal dialysis) were treated in the 28-week extension study (Study-05B) with either Velphoro (N=391) or sevelamer carbonate (N=267) according to their original randomization.
Danish: Efter afslutning af Studie-05A blev 658 patienter (597 i hæmodialyse og 61 i peritonealdialyse) behandlet i det 28 uger lange forlængede studie (Studie-05B) med enten Velphoro (N = 391) eller sevelamer-karbonat (N = 267) i overensstemmelse med deres oprindelige randomisering.
English: However, no evidence of hepatic impairment or significant alteration of hepatic enzymes were observed in the clinical studies with Velphoro.
Danish: Der blev dog ikke observeret tegn på leverinsufficiens eller væsentlig ændring af leverenzymer i kliniske studier med Velphoro.
English: Velphoro contains potato starch and pregelatinised maize starch.
Danish: Velphoro indeholder kartoffelstivelse og pregelatineret majsstivelse.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON - 30 CHEWABLE TABLETS (5 BLISTERS OF 6 CHEWABLE TABLETS), PART OF MULTIPACK (WITHOUT BLUE BOX)
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE YDERPAKNING - 30 TYGGETABLETTER (5 BLISTERKORT MED HVER 6 TYGGETABLETTER), DEL AF MULTIPAKKE (UDEN BLÅ ÆSKE)
English: Serum phosphorus levels must be monitored and the dose of Velphoro up or down titrated in increments of 500 mg iron (1 tablet) per day every 2 - 4 weeks until an acceptable serum phosphorus level is reached, with regular monitoring afterwards.
Danish: Serumfosfatniveauet skal overvåges, og dosis af Velphoro skal titreres op eller ned i trin på 500 mg jern (1 tablet) dagligt hver 2.-4. uge, indtil der opnås et acceptabelt serumfosfatniveau.
English: Velphoro can cause black stools.
Danish: Velphoro kan forårsage sort afføring.
English: At the end of week 24, 93 patients on hemodialysis whose serum phosphorus levels were controlled (<1.78 mmol/L) with Velphoro in the first part of the study, were re-randomized to continue treatment with either their week 24 maintenance dose (N=44 or a non-effective low dose control 250 mg iron/day, N=49) of Velphoro for a further 3 weeks.
Danish: I slutningen af uge 24 blev 93 patienter i hæmodialyse, hvis serumfosfatniveauer blev kontrolleret (< 1,78 mmol/l) med Velphoro i den første del af studiet, igen randomiseret til enten at fortsætte behandlingen med deres vedligeholdelsesdosis fra uge 24 (N = 44) eller en ikke-effektiv lavdosiskontrol på 250 mg jern/dag (N = 49) af Velphoro i yderligere 3 uger.
English: Serum phosphorus levels are reduced as a consequence of the reduced dietary phosphate absorption.
Danish: Niveauerne af serumfosfat reduceres som en følgevirkning af den reducerede absorption af fosfat i kosten.
English: The chewable tablets are brown, circular, and embossed with PA500 on one side.
Danish: Tyggetabletterne er brune, runde tabletter præget med PA500 på den ene side.
English: In animal studies, there were no adverse effects on mating performance, fertility, and litter parameters following treatment with Velphoro (see section 5.3).
Danish: Dyreforsøg har ikke påvist bivirkninger på forplantningsevnen, fertilitet og kuldparametre efter behandling med Velphoro (se pkt.
English: Although the potential for interactions with medicinal products seems low, for concomitant treatment with medicinal products with a narrow therapeutic window, the clinical effect and adverse events should be monitored, on initiation or doseadjustment of either Velphoro or the concomitant medicinal product, or the physician should consider measuring blood levels.
Danish: Selv om risikoen for interaktion med andre lægemidler er lav, skal de kliniske virkninger og bivirkninger observeres ved samtidig behandling med lægemidler med et smalt terapeutisk vindue ved påbegyndelse eller justering af dosis af enten Velphoro eller det lægemiddel, der gives sideløbende.
English: Velphoro is a medicine that contains the active substance sucroferric oxyhydroxide, which is made up from iron, sugar (sucrose) and starches.
Danish: Velphoro er et lægemiddel, der indeholder det aktive stof sucroferrioxyhydroxid, som består af jern, sukker (saccharose) og stivelse.
English: Mean serum phosphorus levels were 2.5 mmol/L at baseline and 1.8 mmol/L at week 12 for Velphoro (reduction by 0.7 mmol/L).
Danish: Det gennemsnitlige serumfosfatniveau var 2,5 mmol/l ved baseline og 1,8 mmol/l ved uge 12 for Velphoro (fald på 0,7 mmol/l).
English: The usual recommended starting dose is the equivalent of 1,500 mg iron per day (3 tablets).
Danish: Den sædvanlige, anbefalede startdosis svarer til 1.500 mg jern dagligt (3 tabletter).
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each chewable tablet contains 500 mg iron as sucroferric oxyhydroxide also known as a mixture of polynuclear iron(III)-oxyhydroxide, sucrose, and starches.
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Hver tyggetablet indeholder 500 mg jern i form af sucroferrioxyhydroxid, der også er kendt som en blanding af polynukleært jern(III)-oxyhydroxid, saccharose og stivelse.
English: If you stop taking Velphoro
Danish: Hvis du stopper med at tage Velphoro
English: Velphoro contains a mixture of polynuclear iron(III)-oxyhydroxide (pn-FeOOH), sucrose and starches.
Danish: Velphoro indeholder en blanding af polynukleært jern(III)-oxyhydroxid (pn-FeOOH), saccharose og stivelse.
English: Pack sizes of 30 × 1 or multipack of 90 (3 packs of 30 × 1) chewable tablets.
Danish: Pakningsstørrelser med 30 × 1 eller multipakke med 90 (3 pakker á 30 × 1) tyggetabletter.
English: What you need to know before you take Velphoro
Danish: Det skal du vide, før du begynder at tage Velphoro
English: Discoloured (black) stool may visually mask gastrointestinal bleeding (see section 4.5).
Danish: Misfarvet/sort afføring kan visuelt skjule gastrointestinale blødninger (se pkt.
English: If you forget to take Velphoro
Danish: Hvis du har glemt at tage Velphoro
English: Nausea Constipation Vomiting Dyspepsia Abdominal pain Flatulence Tooth discolouration
Danish: Kvalme Forstoppelse Opkastning Dyspepsi Abdominalsmerter Flatulens Misfarvning af tænder
English: Other medicines and Velphoro
Danish: Brug af anden medicin sammen med Velphoro
English: A decision on whether to continue breast-feeding or to continue therapy with Velphoro should be made taking into account the benefit of breast-feeding to the child and the benefit of Velphoro therapy to the mother.
Danish: Det skal besluttes, om amning eller behandling med Velphoro skal ophøre, idet der tages højde for fordelene ved amning for barnet i forhold til de terapeutiske fordele for moderen.
English: Velphoro works by binding phosphorus from food in your digestive tract (stomach and intestines).
Danish: Velphoro fungerer ved at binde fosfat fra maden i fordøjelseskanalen (mave og tarme).
English: In Study-05A, 1,055 patients on hemodialysis (N=968) or peritoneal dialysis (N=87) with serum phosphorus ≥1.94 mmol/L following a 2 - 4-week phosphate binder washout period, were randomized and treated with either Velphoro, at a starting dose of 1,000 mg iron/day (N=707), or active-control (sevelamer carbonate, N=348) for 24 weeks.
Danish: I Studie-05A blev 1.055 patienter i hæmodialyse (N = 968) eller peritonealdialyse (N = 87) med serumfosfat ≥ 1,94 mmol/l efter en 2-4 ugers periode med udvaskning af fosfatbinder randomiseret og behandlet med enten Velphoro med en startdosis på 1.000 mg jern/dag (N = 707) eller aktivt kontrolleret (sevelamer-karbonat, N = 348) i 24 uger.
English: They have been conducted in healthy human male and female subjects with losartan, furosemide, digoxin, warfarin, and omeprazole.
Danish: Disse studier er blevet udført med losartan, furosemid, digoxin, warfarin og omeprazol hos raske mandlige og kvindelige forsøgspersoner.
English: If you have black stools and also have symptoms like increasing tiredness and breathlessness contact your doctor immediately (see section 4).
Danish: Kontakt øjeblikkeligt lægen, hvis du har sort afføring og også har symptomer som øget træthed og åndenød (se punkt 4).
English: Velphoro is almost not absorbed from the gastrointestinal tract.
Danish: Velphoro optages næsten ikke i mave-tarm-kanalen.
English: Velphoro can cause discoloured (black) stool.
Danish: Velphoro kan forårsage misfarvet/sort afføring.
English: PHARMACEUTICAL FORM AND CONTENTS Multipack: 90 (3 packs of 30) chewable tablets.
Danish: LÆGEMIDDELFORM OG INDHOLD (PAKNINGSSTØRRELSE) Multipakke: 90 tyggetabletter (3 pakker á 30).
English: Ask your doctor if you are not sure.
Danish: Kontakt lægen, hvis du er i tvivl.
English: There are no available clinical data from the use of Velphoro in breast-feeding women.
Danish: Der er ingen kliniske data fra anvendelse af Velphoro til ammende kvinder.
English: LIST OF EXCIPIENTS Contains sucrose, potato starch and pregelatinised maize starch.
Danish: Indeholder saccharose, kartoffelstivelse og pregelatineret majsstivelse.
English: - The active substance is iron as sucroferric oxyhydroxide also known as a mixture of polynuclear iron(III)-oxyhydroxide, sucrose, and starches.
Danish: - Det aktive stof er jern i form af sucroferrioxyhydroxid, der også er kendt som en blanding af polynukleært jern(III)-oxyhydroxid, saccharose og stivelse.
English: 100-101 Terrasse Boieldieu Tour Franklin La Défense 8 92042 Paris la Défense Cedex France
Danish: 100-101 Terrasse Boieldieu Tour Franklin La Défense 8 92042 Paris la Défense Cedex FRANKRIG
English: 100-101 Terrasse Boieldieu Tour Franklin La Défense 8 92042 Paris la Défense Cedex FRANCE
Danish: 100-101 Terrasse Boieldieu Tour Franklin La Défense 8 92042 Paris la Défense Cedex Frankrig
English: Velphoro is indicated for the control of serum phosphorus levels in adult chronic kidney disease (CKD) patients on haemodialysis (HD) or peritoneal dialysis (PD).
Danish: Velphoro er indiceret til voksne til kontrol af serumfosfatniveauet hos patienter med kronisk nyresygdom (CKD), som er i behandling med hæmodialyse (HD) eller peritonealdialyse (PD).
English: Since absorption of iron from Velphoro is minimal (see section 5.2), excretion of iron from Velphoro in breast milk is unlikely.
Danish: 5.2), er udskillelsen af jern fra Velphoro i human mælk usandsynlig.
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING LABEL - BOTTLE OF 30 AND 90 CHEWABLE TABLETS
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN INDRE EMBALLAGE ETIKETTE - FLASKE MED 30 OG 90 TYGGETABLETTER
English: The recommended starting dose of Velphoro is 1,500 mg iron (3 tablets) per day, divided across the meals of the day.
Danish: Den anbefalede startdosis for Velphoro er 1.500 mg jern (3 tabletter) dagligt i forbindelse med dagens måltider.
English: See further information in section 4.4.
Danish: Se yderligere oplysninger i pkt.
English: Velphoro does not affect guaiac based (Haemoccult) or immunological based (iColo Rectal and Hexagon Obti) faecal occult blood tests.
Danish: Velphoro påvirker ikke prøver for okkult blod i afføringen med guaiac (Hæmoccult) eller immunologiske præparater (iColo Rectal og Hexagon Opti).
English: Talk to your doctor or pharmacist before taking Velphoro: - if you have had peritonitis, an inflammation of the peritoneum (the thin tissue that lines the inner wall of the abdomen) within the last 3 months, - if you have significant stomach and/or liver problems, - if you have had major surgery on your stomach and/or intestines.
Danish: Kontakt lægen eller apotekspersonalet, før du tager Velphoro: - hvis du har haft bughindebetændelse (betændelse i det tynde væv, der ligger som en hinde på den indvendige side af bugvæggen) inden for de sidste 3 måneder.
English: NAME OF THE MEDICINAL PRODUCT Velphoro 500 mg chewable tablets
Danish: LÆGEMIDLETS NAVN Velphoro 500 mg tyggetabletter
English: PHARMACEUTICAL FORM AND CONTENTS 30 × 1 chewable tablets
Danish: LÆGEMIDDELFORM OG INDHOLD (PAKNINGSSTØRRELSE) 30 × 1 tyggetablet
English: MARKETING AUTHORISATION NUMBER(S) EU/1/14/943/001 30 chewable tablets
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) EU/1/14/943/001 30 tyggetabletter
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON - BOTTLE OF 30 AND 90 CHEWABLE TABLETS
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE YDERPAKNING - FLASKE MED 30 OG 90 TYGGETABLETTER
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON -30 CHEWABLE TABLETS (5 BLISTERS OF 6 CHEWABLE TABLETS)
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE YDERPAKNING - 30 TYGGETABLETTER (5 BLISTERKORT MED HVER 6 TYGGETABLETTER)
English: Mucosal hyperplasia, with diverticulum/cyst formation was observed in the colon and caecum of mice after 2-years treatment, but this was considered a species-specific effect with no diverticula/cysts seen in long term studies in rats or dogs.
Danish: Der blev observeret slimhindehyperplasi med dannelse af divertikler/cyster i colon og caecum i mus efter 2 års behandling.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/14/943/003
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) EU/1/14/943/003
English: MARKETING AUTHORISATION NUMBER(S) EU/1/14/943/004
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) EU/1/14/943/004
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON (MULTIPACK) - 90 (3 PACKS OF 30) CHEWABLE TABLETS
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE YDERPAKNING (MULTIPAKKE) - 90 TYGGETABLETTER (3 PAKKER MED HVER 30)
English: Velphoro is for use by adult patients who undergo haemodialysis or peritoneal dialysis (procedures to eliminate toxic substances from the blood) because of chronic kidney disease; it is used in order to help control the phosphorus level in their blood when it is too high (hyperphosphataemia).
Danish: Velphoro bruges til voksne patienter, der skal i hæmodialyse eller peritonealdialyse (procedurer, som fjerner giftstoffer fra blodet) på grund af en kronisk nyresygdom.
English: High density polyethylene (HDPE) bottle with child-resistant polypropylene closure and foil induction seal, containing a molecular sieve desiccant and cotton.
Danish: Flaske af højdensitetspolyethylen (HDPE) med børnesikret polypropylenlukning og folieforsegling, der indeholder et tørremiddel med molekularsieve og vat. Pakningsstørrelser med 30 eller 90 tyggetabletter.
English: NAME OF THE MEDICINAL PRODUCT Velphoro 500 mg chewable tablets iron as sucroferric oxyhydroxide
Danish: LÆGEMIDLETS NAVN Velphoro 500 mg tyggetabletter Jern i form af sucroferrioxyhydroxid
English: How to take Velphoro
Danish: Sådan skal du tage Velphoro
English: Multipacks are available for the blister packs with 90 chewable tablets (containing 3 individual packs of 30 × 1 chewable tablets each).
Danish: Blisterpakker med 90 tyggetabletter fås som multipakker (3 enkeltpakker med 30 × 1 tyggetabletter).
English: PHARMACEUTICAL FORM AND CONTENTS 30 chewable tablets
Danish: LÆGEMIDDELFORM OG INDHOLD (PAKNINGSSTØRRELSE) 30 tyggetabletter
English: Each chewable tablet contains 500 mg iron as sucroferric oxyhydroxide.
Danish: Hver tyggetablet indeholder 500 mg jern i form af sucroferrioxyhydroxid.
English: Package leaflet: Information for the patient Velphoro 500 mg chewable tablets iron as sucroferric oxyhydroxide
Danish: Indlægsseddel: Information til brugeren Velphoro 500 mg tyggetabletter Jern i form af sucroferrioxyhydroxid
English: Black stools may occur very commonly in patients taking Velphoro.
Danish: Det er meget almindeligt, at patienter, der tager Velphoro, får sort afføring.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each chewable tablet contains 500 mg iron as sucroferric oxyhydroxide.
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver tyggetablet indeholder 500 mg jern i form af sucroferrioxyhydroxid.
English: Colloidal anhydrous silica 6.2 Incompatibilities
Danish: 6.2 Uforligeligheder
English: Discoloured stool
Danish: Misfarvet afføring
English: What Velphoro is and what it is used for What you need to know before you take Velphoro How to take Velphoro
Danish: Det skal du vide, før du begynder at tage Velphoro Sådan skal du tage Velphoro Bivirkninger
English: (listed in section 6) - if you have a history of abnormal iron build-up in your organs (haemochromatosis) - if you have any other disorder associated with too much iron.
Danish: - hvis du tidligere har haft unormal ophobning af jern i kroppens organer (hæmokromatose).
English: Child-resistant aluminium/aluminium perforated unit-dose blister, each blister containing 6 chewable tablets.
Danish: Børnesikret, perforeret enkeltdosisblisterpakning af aluminium/aluminium.
English: Velphoro is indicated for the control of serum phosphorus levels in adult CKD patients on HD or PD.
Danish: Velphoro er indiceret til voksne til kontrol af serumfosfatniveauet hos patienter med CKD, som er i behandling med HD eller PD. Der foreligger ingen kliniske data for Velphoro hos patienter med tidligere stadier af nyreinsufficiens.
English: If you also have symptoms like increasing tiredness and breathlessness contact your doctor immediately (see section 2 “Warnings”).
Danish: Kontakt øjeblikkeligt lægen, hvis du også har symptomer som øget træthed og åndenød (se pkt.
English: What Velphoro looks like and contents of the pack
Danish: Udseende og pakningsstørrelser
English: The final opinion was converted into a Decision by the European Commission on 27 April 2010.
Danish: Den endelige udtalelse blev konverteret til en afgørelse truffet af Europa-Kommissionen den 27. april
English: EMA/183104/2010 Veterinary Medicines
Danish: EMA/183104/2010 Veterinærlægemidler
English: Article 6(12) of Regulation (EC) No 1084/2003.
Danish: Artikel 6, stk. 12, i forordning (EF) nr. 1084/2003.
English: The application was submitted in the framework of Article 6 of Commission Regulation (EC) No 1084/2003, where the reference Member State was Germany and the concerned Member States were Austria, Belgium, Denmark, Greece, Spain, Finland, Ireland, Italy, Luxemburg, the Netherlands, Norway, Portugal and Sweden.
Danish: Ansøgningen blev indgivet i henhold til artikel 6 i Kommissionens forordning (EF) nr. 1084/2003, hvor referencemedlemsstaten var Tyskland, og de berørte medlemsstater var Østrig, Belgien, Danmark, Grækenland, Spanien, Finland, Irland, Italien, Luxembourg, Nederlandene, Norge, Portugal og Sverige.
English: The referral procedure started on 14 July 2009.
Danish: Indbringelsesproceduren indledtes den 14. juli 2009.
English: The rapporteur and co-rapporteur appointed were Dr. R. Breathnach and Dr. M. Holzhauser-Alberti respectively.
Danish: Den udpegede rapportør og medrapportør var henholdsvis dr. R. Breathnach og dr. M. Holzhauser-Alberti.
English: The mutual recognition procedures (DE/V/0103/001/II/007, DE/V/0103/002/II/007 and DE/V/0103/004/II/007) started on 3 December
Danish: Procedurerne for gensidig anerkendelse (DE/V/0103/001/II/007, DE/V/0103/002/II/007 og DE/V/0103/004/II/007) blev indledt den 3. december 2008.
English: tablet for dogs
Danish: for Vasotop P tablet til hunde
English: International non-proprietary name (INN): ramipril
Danish: Internationalt fællesnavn (INN): ramipril
English: Oral explanations were given on 11 November
Danish: Den mundtlige redegørelse blev fremsat den 11. november 2009.