natgillin/translations-raw huggingface dataset:
CHMP fandt, at Fexeric er effektivt til at kontrollere blodets indhold af fosfat hos patienter med langvarig nyresygdom, hvad enten de er i dialyse eller ej.
The CHMP considered that Fexeric is effective at controlling blood-phosphate levels in patients with long-term kidney disease, whether they are on dialysis or not.
Fexeric er et lægemiddel, der anvendes til at kontrollere for højt fosfatindhold i blodet (hyperfosfatæmi) hos voksne med langvarig nyresygdom.
Fexeric is a medicine used to control hyperphosphataemia (high levels of phosphate in the blood) in adults with long-term kidney disease.
Ophobning af fosfat medfører for højt fosfatindhold i blodet (hyperfosfatæmi), hvilket i det lange løb kan give komplikationer i form af
A build-up of phosphate leads to hyperphosphataemia and in the long-term can cause complications such as heart
Det indeholder det aktive stof jerncitrat (ferricitrat) som koordinationskompleks.
It contains the active substance ferric citrate coordination
Hvis du ønsker praktisk vejledning om anvendelsen af Fexeric, kan du læse indlægssedlen eller
For practical information about using Fexeric, patients should read the package leaflet or contact their
Patienten bør overholde den fosfatfattige kost, der er
Patients should keep to their prescribed low
Den fuldstændige liste over indberettede bivirkninger ved Fexeric fremgår af indlægssedlen.
For the full list of all side effects reported with
Hvad er Sliwens?
What is Sliwens?
20. januar 2009 EMA/139264/2010 EMEA/H/C/1102
EMA/23705/2010 EMEA/H/C/1102
Virkningerne af Sliwens blev først afprøvet i forsøgsmodeller, inden de blev undersøgt hos mennesker.
The effects of Sliwens were first tested in experimental models before being studied in humans.
Det skulle have været leveret som tabletter.
It was to be available as tablets.
Hvad forventedes Sliwens anvendt til?
What was Sliwens expected to be used for?
De vigtigste mål for virkningen var baseret på, hvor lang tid patienterne lå vågne, efter at de først var faldet i søvn, samt forbedringer af søvnkvaliteten i løbet af de første fire til 12 uger af behandlingen.
The main measures of effectiveness were based on the amount of time the patients spent awake after they had first fallen asleep and improvements in the quality of sleep over the first four to 12 weeks of treatment.
Sliwens er et lægemiddel, der indeholder det aktive stof eplivanserin.
Sliwens is a medicine that contains the active substance eplivanserin.
Virksomheden fremlagde resultater af fire hovedundersøgelser med deltagelse af over 3 000 voksne med søvnproblemer.
The company presented results of four main studies involving over 3,000 adults who had difficulty staying asleep.
Det skulle anvendes til patienter, som har besvær med at sove igennem.
It was to be used in patients who have difficulty staying asleep.
Der manglede også oplysninger om effekten af langvarig brug af Sliwens sammenlignet med placebo.
There was also a lack of information comparing the long-term use of Sliwens with placebo.
Det aktive stof i Sliwens, eplivanserin, er en 5-hydroxytryptamin-receptorantagonist.
The active substance in Sliwens, eplivanserin, is a 5-hydroxytryptamine receptor antagonist.
I undersøgelserne blev Sliwens sammenlignet med placebo (en virkningsløs behandling).
The studies compared Sliwens with placebo (a dummy treatment).
Tilbagetrækning af ansøgningen om markedsføringstilladelse for Sliwens (eplivanserin)
Withdrawal of marketing authorisation application for Sliwens (eplivanserin)
Udvalget havde også betænkeligheder med hensyn til risikoen for diverticulitis (betændelse i små lommer i tarmene) hos patienter, der får medicinen.
The Committee was also concerned about the risk of diverticulitis (inflammation in little sacs or pouches in the intestines) in patients taking the medicine.
Den 18. december 2009 meddelte Sanofi-Aventis officielt Udvalget for Humanmedicinske Lægemidler (CHMP), at virksomheden ønskede at tilbagetrække sin ansøgning om markedsføringstilladelse for Sliwens til behandling af voksne med kronisk (langvarig) insomni, som har besvær med at sove igennem.
On 18 December 2009, Sanofi-Aventis officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Sliwens, for use in adults with chronic (long-term) insomnia who have difficulty staying asleep.
CHMP fandt, at Sliwens' effekt på søvn var lille.
The CHMP considered the effect of Sliwens on sleep to be small.
Det blokerer receptorer i hjernen kaldet 5-hydroxytryptamin type 2-receptorer, som medvirker ved reguleringen af de perioder i døgnet, hvor man er vågen eller sover.
It blocks receptors in the brain called 5-hydroxytryptamine type 2 receptors, which are involved in regulating the daily cycle of being asleep and being awake.
I den femte undersøgelse med deltagelse af 283 voksne blev Sliwens sammenlignet med lormetazepam (et andet lægemiddel til behandling af insomni), og man så på, hvor søvnige patienterne var om morgenen efter at have taget Sliwens.
study involving 283 adults compared Sliwens with lormetazepam (another medicine used to treat insomnia) looked at how sleepy the patients were the morning after taking Sliwens.
På baggrund af gennemgangen af dataene og virksomhedens besvarelse af CHMP's liste med spørgsmål på tidspunktet for tilbagetrækningen af ansøgningen havde CHMP visse betænkeligheder og var af den foreløbige opfattelse, at Sliwens ikke kunne have været godkendt.
Based on the review of the data and the company's response to the CHMP list of questions, at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Sliwens could not have been approved.
Virksomheden har informeret CHMP om, at der ikke er nogen konsekvenser for patienter, som deltager i kliniske undersøgelser eller i programmer for anvendelse med særlig udleveringstilladelse, eftersom alle igangværende kliniske undersøgelser er blevet afbrudt.
The company informed the CHMP that there were no consequences for patients in clinical trials or compassionate use, since all ongoing clinical trials have been discontinued.
Tilbagetrækning af ansøgningen om markedsføringstilladelse for Sliwens (eplivanserin) EMA/139264/2010
Withdrawal of marketing authorisation application for Sliwens (eplivanserin) EMA/23705/2010
Ved at blokere disse receptorer forventedes eplivanserin at ændre disse perioder og således hjælpe personer med langvarig insomni med at sove igennem.
By blocking these receptors, eplivanserin was expected to modify the sleep-wake cycle, helping people with long-term insomnia to stay asleep.
Sliwens forventedes anvendt til voksne med langvarig insomni (søvnbesvær).
Sliwens was expected to be used in adults with long-term insomnia (difficulty sleeping).
Hvordan forventedes Sliwens at virke?
How was Sliwens expected to work?
Grækenland VIOSER SA, 9th Km National Highway TrikalaLarissis,
VIOSER SA, 9th Km National Highway TrikalaLarissis,
B-dul Theodor Pallady nr. 50, sector 3,
B-dul Theodor Pallady nr. 50, sector 3, Bucureşti,
Leskoškova cesta 9D 1000 Ljubljana
Leskoškova cesta 9D 1000 Ljubljana Slovenia
Strada Fânarului nr. 2A, 500464 Braşov,
Strada Fânarului nr. 2A, 500464 Braşov, Romania
Bulgarien Fresenius Kabi EOOD 1 "Alexander Jendov" str.
Fresenius Kabi EOOD "Alexander Jendov" str.
Slovenien Medias International d.o.o.
Medias International d.o.o.
Rumænien S.C. Fresenius Kabi Romania S.R.L, strada Fanarului nr. 2A, 500464 Brasov,
S.C. Fresenius Kabi Romania S.R.L, strada Fanarului nr. 2A, 500464 Brasov, Romania
Rumænien S.C. FRESENIUS KABI ROMÂNIA S.R.L.
S.C. FRESENIUS KABI ROMÂNIA S.R.L.
Rumænien S.C. INFOMED FLUIDS S.R.L.,
S.C. INFOMED FLUIDS S.R.L.,
Rumænien S.C. INFOMED FLUIDS S.R.L.
S.C. INFOMED FLUIDS S.R.L.
Hydroxyethylstivelse 10% Hydroksyetyloskrobia 200/0,5 Baxter
Hydroksyetyloskro bia 200/0,5 Baxter
Grækenland VIOSER SA 9th Km National Highway Trikal-Larissa, P.O. Box 35, Taksiarhes Trikalon,
9th Km National Highway Trikal-Larissa, P.O.
Bulgarien Baxter Deutschland GmbH,
Baxter Deutschland GmbH
Poli(O-2hydroxyethyl)-stivelse
Poli(O-2-hydroxyethyl) starch
Poly-(o-2 hydroxyethyl)-stivelse (M.W 200000) + natriumchlorid
Poly-(o-2 hydroxyethyl)starch (M.W 200000) + Sodium Chloride
Slovenien Baxter d.o.o.
Baxter d.o.o.
60 g/l, 72 g/l, vand ad 1000 ml
60 g/l, 72 g/l, water ad 1000 ml
Bucureşti,
VIOSER SA
100 g/l, 9 g/l, vand ad 1000 ml
100 g/l, 9 g/l, water ad 1000 ml
substitution 0,45-0,55, natriumchlorid
0.450.55 AV. MW 200K, sodium chloride
Molenberglei 7 2627 Schelle Belgium aktivt stof:
Fresenius Kabi Nederland B.V. Molenberglei 7 2627 Schelle Belgium active substance: hydroxyethyl starch (MR
Neo Irakleion 14121, Athens
BAXTER HELLAS Ltd, Metsovou 3, Neo Irakleion 14121, Athens Greece
Poly(O-2hydroxyethyl)-stivelse mol.
Poly (O-2-hydroxyethyl) starch mol.
Baxter Deutschland GmbH Edisonstr.
Baxter Deutschland GmbH, Edissonstrasse 4+Unterschleissheim,
United Kingdom poly(o-2hydroxyethyl)-stivelse natriumacetattrihydrat natriumchlorid kaliumchlorid magnesiumchloridhexa hydrat
United Kingdom poly(o-2hydroxyethyl)starch sodium acetate trihydrate sodium chloride potassium chloride magnesium chloride hexahydrate
60 g/l, 9 g/l, vand ad 1000 ml
60 g/l, 9 g/l, water ad 1000 ml
Poli(O-2hydroxyethyl)-stivelse, natriumchlorid
Poli(O-2-hydroxyethyl) starch, Sodium chloride
United Kingdom poly (o-2hydroxyethyl)-stivelse natriumchlorid
United Kingdom poly (o-2hydroxyethyl)starch sodium chloride
Storbritannien Baxter Healthcare Limited, Caxton Way, Thetford, Norfolk IP24
Caxton Way, Thetford, Norfolk IP24 3SE United Kingdom
60 g/l, 0,3 g/l, 0,3 g/l, 6,02 g/l, 4,63 g/l, vand ad 1000 ml
60 g/l, 0,3 g/l, 0,3 g/l, 6,02 g/l, 4,63 g/l, water ad 1000 ml
Hydroxyethylstivelse (HES), natriumchlorid, vand
Hydroxyethyl starch (HES), sodium chloride, water
0,134 g/l, 60 g/l, 0,4 g/l, 0,2 g/l, 6 g/l, 3,7 g/l, vand ad 1000 ml
0,134 g/l, 60 g/l, 0,4 g/l, 0,2 g/l, 6 g/l, 3,7 g/l, water ad 1000 ml
Rumænien B. BRAUN MELSUNGEN AG,
B. BRAUN MELSUNGEN AG,
Natriumchlorid, hydroxyethylstivelse
Sodium Chlorid, Hydroxyethyl starch
Poly-(o-2hydroxyethyl)-stivelse (M.W 200000) + natriumacetattrihydrat + natriumchlorid + kaliumchlorid + magnesiumchloridhexa hydrat
Poly-(o-2-hydroxyethyl)starch (M.W 200000) + sodium acetate trihydrate + sodium chloride + potassium chloride + magnesium chloride hexahydrate
Poly(O-2-hydoxyethyl)stivelse 130/0,4, natriumchlorid, natriumacetattrihydrat, kaliumchlorid, magnesiumchloridhexa hydrat
Poly(O-2hydoxyethyl)starch 130/0.4, Sodium chloride, Sodium acetate trihydrate, Potassium chloride, Magnesium chloride hexahydrate
0,37 g/l, 100 g/l, 0,3 g/l, 0,2 g/l, 6,25 g/l, 3,27 g/l, 0,67 g/l, 1,197 g/l, vand ad 1000 ml
0,37 g/l, 100 g/l, 0,3 g/l, 0,2 g/l, 6,25 g/l, 3,27 g/l, 0,67 g/l, 1,197 g/l, water ad 1000 ml
0,37 g/l, 60 g/l, 0,3 g/l, 0,2 g/l, 6,25 g/l, 3,27 g/l, 0,67 g/l, 1,197 g/l, vand ad 1000 ml
0,37 g/l, 60 g/l, 0,3 g/l, 0,2 g/l, 6,25 g/l, 3,27 g/l, 0,67 g/l, 1,197 g/l, water ad 1000 ml
Hydroxyethylstivelse Haes-Steril 6% 60 mg/ml
Haes-Steril 6% 60 mg/ml
Storbritannien B Braun Melsungen AG Carl-Braun-Strasse 1
Belgium B. Braun Melsungen AG Carl-Braun-Strasse 1
D-34212 Melsungen, Germany
Str.1, D34212 Melsungen, Germany
Poly(O-2hydroxyethyl)-stivelse (HES), natriumchlorid
Poly(O-2-hydroxyethyl) starch (HES), Sodium chloride
Hydroxyethylstivelse HAES - steril 10% 100 g/l
HAES - steril 10% 100 g/l
Hydroxyethyl)-stivelse, natriumchlorid
Hydroxyethy starch, Sodium chloride
Hydroxyethylstivelse Stabisol
Hydroxyethyl Starch
Slovenien Fresenius Kabi Deutschland GmbH 61346 Bad Homburg v.d.H.
Luxembourg Fresenius Kabi Deutschland GmbH 61346 Bad Homburg v.d.H
Hydroxyethylstivelse Haes-Steril 10% 100 mg/ml
Haes-Steril 10% 100 mg/ml
B. Braun Melsungen AG (Melsungen) Carl-Braun-Strasse 1 34212 Melsungen Germany aktivt stof:
B. Braun Melsungen AG (Melsungen) Carl-Braun-Strasse 1 34212 Melsungen Germany active substance: hydroxyethyl starch (MR
Natriumchlorid, kaliumchlorid, magnesiumchloridhexa hydrat, natriumacetattrihydrat, æblesyre, poly(0-2hydroxyethyl)-stivelse, calciumchloriddihydrat
Sodium chloride, potassium chloride, magnesium chloride hexahydrate, sodium acetate trihydrate, malic acid, poly (0-2hydroxyethyl) starch, calcium chloride dihydrate
Poli(0-2-hydroxyethyl)stivelse(HEK), natriumchlorid, kaliumchlorid, calciumchloriddihydrat, magnesiumchloridhexa hydrat, natriumacetattrihydrat, æblesyre
Poli(0-2hydroxyethyl)starch(HEK) , Sodium chloride, Potassium chloride, Calcium chloride dihydrate, Magnesium chloride heksahydrate, Sodium acetate trihydrate, Malic acid
INFOHES 60 g/L
60 g/l
Natriumchlorid, kaliumchlorid, calciumchloriddihydrat, magnesiumchloridhexa hydrat, natriumacetattrihydrat, æblesyre, poly(0-2hydroxyethyl)-stivelse
Sodium chloride, potassium chloride, calcium chloride dihydrate, magnesium chloride hexahydrate,sodium acetate trihydrate, malic acid, poly (0-2hydroxyethyl) starch
Hydroxyethylstivelse,
Hydroxyethyl Starch,
INFOHES 100 g/L
100 g/l
0,20 g/l, 3,27 g /l, 0,67 g/l
0.37 g/l, 0.2g/l, 3.27 g/l, 0.67 g/l
substitution 0,38-0,45, natriumacetattrihydrat, natriumchlorid, kaliumchlorid, magnesiumchloridhexa hydrat
Poly(0-2hydroxyethyl)starch 130 kDa mol.substitution 0,38-0,45 , Sodium acetate trihydrate, sodium chloride, potassium chloride, magnesium chloride hexahydrate
Poly(O-2hydroxyethyl)-stivelse, natriumchlorid
Poly(o-2-hydroxyethyl) Starch, Sodium Chloride
Poly(0-2hydroxyethyl)-stivelse 130 kDa mol.
Poly(0-2hydroxyethyl)starch 130 kDa mol.substitution 0,42 , Sodium chloride
Natriumacetat (trihydrat), kaliumchlorid, magnesiumchloridhexa hydrat, natriumchlorid, calciumchlorid (dihydrat), hydroxyethylstivelse
Sodium Acetate (Trihydrate), Potassium Chlorid, Magnesium Chlorid Hexahydrate, Sodium Chlorid, Calcium Chlorid (Dihydrate), Hydroxyethyl starch
Tetraspan 6 % 60g/l, 6,25g/l, 0,30 g/l, 0,37 g/l, 0,20 g/l,
Tetraspan 6 % 60g/l, 6,25g/l, 0,30 g/l, 0.37 g/l,
Hydroxyethylstivelse, natriumchlorid, kaliumchlorid, calciumchlorid, magnesiumchloridhexa hydrat, sodium acetate, æblesyre
Sodium Chloride, malic acid, Calcium Chloride, Potassium Chloride, Magnesium Chloride, Sodium acetate
Calciumchloriddihydrat, hydroxyethylstivelse (HES), kaliumchlorid, magnesiumchlorid hexahydrat, natriumchlorid, natriumacetattrihydrat, vand
Calcium chloride dihydrate, hydroxyethyl starch (hes), potassium chloride, magnesium chloride hexahydrate, sodiumchloride, sodium acetate trihydrate, water
Poly(o-2hydroxyethyl)-stivelse, natriumchlorid
Poly(O-2hydroxyethyl)starch, Sodium chloride
Poly(O-2hydroxyethyl)-stivelse (HES), natriumacetattrihydrat, natriumchlorid, kaliumchlorid, magnesiumchloridhexa hydrat
Poly(O-2-hydroxyethyl) starch (HES), Sodium acetate trihydrate, Sodium chloride, Potassium chloride, Magnesium chloride hexahydrate
Kaliumchlorid + natriumacetattrihydrat + æblesyre + magnesiumchloridhexa hydrat + natriumchlorid + hydroxyethylstivelse + calciumchloriddihydrat
Potassium chloride + Sodium acetate trihydrate + Malic acid + Magnesium chloride hexahydrate + Sodium chloride + Hydroxyethyl starch + Calcium chloride dihydrate
Hydroxyethylstivelse natriumchlorid kaliumchlorid calciumchloriddihydrat magnesiumchloridhexa hydrat natriumacetattrihydrat
Hydroxyethyl starch Sodium chloride Potassium chloride Calcium chloride dihydrate
natriumchlorid, natriumacetattrihydrat, æblesyre, calciumchloridihydrat, kaliumchlorid, magnesiumchloridhexa hydrat
sodium chloride, sodium acetate trihydrate, malic acid, calcium chloride dihydrate, potassium chloride, magnesium chloride hexahydrate
Hydroxyethylstivelse calciumchloriddehydrat magnesiumchloridhexa hydrat æblesyre kaliumchlorid natriumacetattrihydrat natriumchlorid
calcium chloride dihydrate magnesium chloride hexahydrate malic acide potassium chloride sodium acetate trihydrate sodium chloride
Poly(o-2hydroxyethyl)-stivelse, natriumacetattrihydrid, natriumchlorid, kaliumchlorid, magnesiumchloridhexa hydrat
Poly(o-2-hydroxyethyl) Starch, Sodium Acetate Trihydride, Sodium Chloride, Potassium Chloride, Magnesium Chloride Hexahydrate
Calciumchloriddihydrat, hydroxyethylstivelse (HES), kaliumchlorid, magnesiumchloridhexa hydrat, natriumchlorid, natriumacetattrihydrat, æblesyre, natriumhydroxid, vand
Calcium chloride dihydrate, hydroxyethyl starch (HES), potassium chloride, magnesium chloride hexahydrate, sodium chloride, sodium acetate trihydrate, malic acid, sodium hydroxide, water
Natriumacetat (trihydrat), kaliumchlorid, magnesiumchloridhexa hydrat, natriumchlorid, calciumchlorid (dihydrat), hydroxyethylstivelse, æblesyre
Sodium Acetate (Trihydrate), Potassium Chlorid, Magnesium Chlorid Hexahydrate, Sodium Chlorid, Calcium Chlorid (Dihydrate), Hydroxyethyl starch, Malic Acid
Hydroxyethylstivelse + natriumchlorid+natriu macetat trihydrat+kaliumchlorid +magnesiumchloridhex ahydrat
Hydroxyethyl starch + Sodium chloride+Sodium acetate trihydrate+Potassium chloride+Magnesium chloride hexahydrate
natriumchlorid, natriumacetattrihydrat, kaliumchlorid, magnesiumchloridhexa hydrat, calciumchloriddihydrat
sodium chloride, sodium acetate trihydrate, potassium chloride, magnesium chloride hexahydrate, calcium chloride dihydrate
Hydroxyethylstivelse + natriumacetattrihydrat + natriumchlorid + kaliumchlorid + magnesiumchloridhexa hydrat
Hydroxyethyl Starch + Sodium Acetate Trihydrate + Sodium Chloride + Potasium Chloride + Magnesium Chloride Hexahydrate
Slovenien B.Braun Melsungen AG Carl-Braun-Strasse 1
Luxembourg B.Braun Melsungen A.G. Carl-Braun-Straße 1
Poly(o-2hydroxyethyl)-stivelse, natriumchlorid, kaliumchlorid, calciumchloriddihydrat, magnesiumchloriddihyd rat, natriumacetattrihydrat
Poly(o-2-hydroxyethyl) Starch, Sodium Chloride, Potassium Chloride, Calcium Chloride Dihydrate, Magnesium Chloride Dihydrate, Sodium Acetate Trihydride
Hydroxyethylstivelse + natriumchlorid + kaliumchlorid + calciumchloriddihydrat magnesiumchloridhexa hydrat + natriumacetattrihydrat + æblesyre
Hydroxyethyl Starch + Sodium Chloride + Potasium Chloride + Calcium Chloride Dihydrate + Magnesium Chloride Hexahydrate + Sodium Acetate Trihydrate + Malic Acid
Hydroxyethylstivelse, natriumchlorid, kaliumchlorid, calciumchloridhydrat, magnesiumchloridhydr at, natriumacetathydrat, hydroxysuccinat
Hydroxyethyl Starch, Sodium Chloride, Potassium Chloride, Calcium Chloride Dihydrate, Magnesium Chloride Hexahydrate, Sodium Acetate Trihydrate
Hydroxyethylstivelse, natriumacetattrihydrat, natriumchlorid, kaliumchlorid, magnesiumchloridhexa hydrat
hydroxyethyl starch, Sodium acetate trihydrate, Sodium chloride, Potassium chloride, Magnesium chloride hexahydrate
Poly(O-2hydroxyethyl)-stivelse (HES), natriumchlorid, kaliumchlorid, calciumchloriddihydrat, magnesiumchloridhexa hydrat, natriumacetattrihydrat
Poly (O-2-hydroxyethyl starch (HES), sodium chloride, potassium chloride, calcium chloride dihydrate, magnesium chloride hexahydrate, sodium acetate trihydrate
Hydroxyethylstivelse + natriumchlorid + kaliumchlorid + calciumchloriddihydrat magnesiumchloridhexa hydrat + natriumacetattrihydrat
Hydroxyethyl Starch + Sodium Chloride + Potasium Chloride + Calcium Chloride Dihydrate + Magnesium Chloride Hexahydrate + Sodium Acetate Trihydrate
Hydroxyethylstivelse, natriumacetattrihydrat, natriumchlorid, natriumchlorid, magnesiumchlorid
Hydroxyethyl starch, Sodium acetate trihydrate, Sodium chloride, Sodium chloride, Magnesium chloride
Poly (O-2hydroxyethyl)-stivelse (HES), natriumchlorid, kaliumchlorid, calciumchloriddihydrat, magnesiumchloridhexa hydrat, natriumacetattrihydrat, æblesyre DAB
Poly(O-2-hydroxyethyl) starch (HES), Sodium chloride, Potassium chloride, Calcium chloride dihydrate, Magnesium chloride hexahydrate, Sodium acetate trihydrate, Malic acid
Hydroxyethylstivelse (HES), kaliumchlorid, magnesiumchloridhexa hydrat, natriumchlorid, natriumacetattrihydrat, vand
Hydroxyethyl starch (HES), potassium chloride, magnesium chloride hexahydrate, sodium chloride, sodium acetate trihydrate, water
Natriumacetat (trihydrat), kaliumchlorid, magnesiumchloridhexa hydrat, natriumchlorid, Hydroxyethylstivelse
Sodium Acetate (Trihydrate), Potassium Chlorid, Magnesium Chlorid Hexahydrate, Sodium Chlorid, Hydroxyethyl starch
poly (0-2hydroxyethyl)-stivelse natriumchlorid
United Kingdom poly (0-2hydroxyethyl)starch sodium chloride
natriumchlorid, natriumacetattrihydrat, magnesiumchloridhexa hydrat, kaliumchlorid
sodium chloride, sodium acetate trihydrate, magnesium chloride hexahydrate, potassium chloride
HES, natriumchlorid, kaliumchlorid, calciumchloriddihydrat, magnesiumchloridhexa hydrat, natriumacetattrihydrat
HES, Sodium Chloride, Potassium Chloride, Calcium Chloride Dihydrate, Magnesium Chloride Hexahydrate, Sodium Acetate Trihydrate
Hydroxyethylstivelse, natriumchlorid, kaliumchlorid, calciumchloriddihydrat, magnesiumchloridhexa hydrat natriumacetattrihydrat
Hydroxyethyl starch, Sodium Chloride, Potassium Chloride, Calcium Chloride Dihydrate, Magnesium Chloride Hexahydrate Sodium Acetate Trihydrate
Hydroxyethylstivelse, natriumchlorid, natriumacetattrihydrat, kaliumchlorid, magnesiumchloridhexa hydrat
Hydroxyethyl starch, Sodium chloride, Sodium acetate trihydrate, Potassium chloride, Magnesium chloride hexahydrate
Hydroxyethylstivelse, natriumacetattrihydrat, kaliumchlorid, magnesiumchloridhexa hydrat, natriumchlorid
Hydroxyethyl starch, Sodium acetate trihydrate, Potassium chloride, Magnesium chloride hexahydrate, Sodium chloride
Natriumchlorid, kaliumchlorid, calciumchloriddihydrat, magnesiumchloridhexa hydrat, natriumacetattrihydrat, hydroxyethylstivelse
HES, Sodium Chloride, Potassium Chloride, Calcium Chloride Dihydrate, Magnesium Chloride Hexahydrate, Sodium Acetate Trihydrate, Malic Acid
Natriumacetattrihydrat + kaliumchlorid + magnesiumchloridhexa hydrat + hydroxyethylstivelse + calciumchloriddihydrat + natriumchlorid
Sodium acetate trihydrate + Potassium chloride + Magnesium chloride hexahydrate + Hydroxyethyl starch + Calcium chloride dihydrate + Sodium chloride
Denne oversigt blev sidst ajourført i 11-2019.
This overview was last updated in 11-2019.
Plegridy fik en markedsføringstilladelse med gyldighed i hele EU den 18. juli 2014.
Plegridy received a marketing authorisation valid throughout the EU on 18 July 2014.
Yderligere information om Plegridy findes på agenturets websted under: ema.europa.eu/medicines/human/EPAR/plegridy.
Further information on Plegridy can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/plegridy.
Behandlingen bør starte med en dosis på 63 mikrogram efterfulgt af en dosis på 94 mikrogram efter to uger og derefter 125 mikrogram hver anden uge.
Treatment should start with a dose of 63 micrograms, followed by a dose of 94 micrograms after two weeks, and then 125 micrograms every two weeks thereafter.
Som for alle lægemidler bliver data vedrørende brug af Plegridy løbende overvåget.
As for all medicines, data on the use of Plegridy are continuously monitored.
Plegridy havde fortsat gavnlige virkninger i det andet behandlingsår.
Plegridy continued to produce benefit in the second year of treatment.
Dette studie blev forlænget med yderligere to år for at undersøge Plegridys langsigtede sikkerhed og virkning, og de tilgængelige data fra forlængelsesfasen på godkendelsestidspunktet svarede til resultaterne af hovedstudiet.
This study was extended for two further years to investigate the long-term safety and efficacy of Plegridy, and available data from the extension phase at the time of approval were consistent with the results of the main study.
Andre oplysninger om Plegridy
Other information about Plegridy
Det primære mål for virkningen var antallet af tilbagefald, som patienterne oplevede over et år, men studiet omfattede også andre målbare faktorer, bl.a. hvor hurtigt patienternes invaliditet skred frem.
The main measure of effectiveness was the number of relapses that patients experienced over one year but the study also looked at other measures including how fast the patients' disability progressed.
Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Plegridy?
What measures are being taken to ensure the safe and effective use of Plegridy?