natgillin/translations-raw huggingface dataset:
Serumphosphat skal overvåges, og dosen af sevelamercarbonat titreres med 0,8 g forøgelse tre gange daglig (2,4 g/dag) hver 2.-4. uge, indtil der nås et acceptabelt serum-phosphat-niveau, med jævnlig monitorering derefter.
Serum phosphorus must be monitored and the dose of sevelamer carbonate titrated by 0.8 g three times per day (2.4 g/day) increments every 2-4 weeks until an acceptable serum phosphorus level is reached, with regular monitoring thereafter.
Serumphosphatniveauet skal overvåges, og dosen af sevelamercarbonat titreres med 0,8 g forøgelse tre gange daglig (2,4 g/dag) hver 2.-4. uge, indtil der nås et acceptabelt serum-phosphat-niveau, med jævnlig monitorering derefter.
Serum phosphorus levels must be monitored and the dose of sevelamer carbonate titrated by 0.8 g three times per day (2.4 g/day) increments every 2-4 weeks until an acceptable serum phosphorus level is reached, with regular monitoring thereafter.
Serumprøver fra 283 forsøgspersoner (224 behandlet med idarucizumab) blev testet for antistoffer mod idarucizumab før og efter behandling.
Serum samples from 283 subjects (224 treated with idarucizumab) were tested for antibodies to idarucizumab before and after treatment.
Serumprøver fra mere end 440 patienter i det kliniske CLL-program blev testet for anti-ofatumumab antistoffer (enten ved enzymforbundet immunosorbent-analyse eller elektrokemiluminescens) under og efter behandlingsperioder fra 4 til 45 uger.
Serum samples from more than 440 patients across the CLL clinical program were tested for anti-ofatumumab antibodies (either by enzyme-linked immunosorbent assay or electrochemiluminescence) during and after treatment periods ranging from 4 to 45 weeks.
Serumprøver fra mere end 440 patienter i det kliniske CLL-program blev testet for anti-ofatumumab- antistoffer (enten ved enzymbundet immunosorbent-analyse eller elektrokemiluminescens) under og efter behandlingsperioder fra 4 til 45 uger.
Serum samples from more than 440 patients across the CLL clinical program were tested for anti-ofatumumab antibodies (either by enzyme-linked immunosorbent assay or electrochemiluminescence) during and after treatment periods ranging from 4 to 45 weeks.
Serumpåvist herpes simplex virus type 2 infektion, N (%)
Serum Herpes Simplex Virus Type 2 Infection, N (%)
Serumreatinin
Serum Creatinine
serumsygdom
hyperglycaemia,
serumsygdom
hypoaesthesia,
serumsygdom
Not known
serumsygdom – en sygdom, der minder om allergi
erum sickness – an illness similar to an allergy
Serumsygdom, anafylaktiske reaktioner, krydsallergiske reaktioner mellem thienopyridiner (såsom ticlopidin, prasugrel) (se
Serum sickness, anaphylactoid reactions, cross-reactive drug hypersensitivity among thienopyridines (such as ticlopidine, prasugrel) (see section 4.4)
Serumsyge
serum sickness
Serumsyge, anafylaksi, polyarteritis nodosa
Serum sickness, Anaphylaxis, Polyarteritis nodosa
serumsyge- lignende reaktion
Serum sickness-like reaction
Serumuratniveauerne blev opretholdt over tid (dvs.
Serum urate levels were maintained over time (i.e.
Serøs nethindeløsning
Serous retinal detachment
Serøs retinopati
Serous retinopathy
sesbesvær
impairment
sestid
Period
Set fra et mikrobiologisk synspunkt skal den rekonstituerede opløsning og infusionsopløsningen med Herceptin anvendes med det samme.
From a microbiological point of view, the reconstituted solution and Herceptin infusion solution should be used immediately.
Set i lysest af de tilgængelige data vedrørende temozolomid, har PRAC vurderet, at ændringerne til produktinformationen er berettigede.
Therefore, in view of available data regarding temozolomide, the PRAC considered that changes to the product information were warranted.
Set i lyset af data præsenteret i den reviderede PSUR, mente PRAC derfor, at ændringer i produktinformationen for lægemidler indeholdende mirabegron, var berettigede.
Therefore, in view of the data presented in the reviewed PSUR, the PRAC considered that changes to the product information of medicinal products containing mirabegron were warranted.
Set i lyset af de data, der blev fremsat i den reviderede PSUR, anså PRAC derfor ændringerne til produktinformationen for lægemidler indeholdende paclitaxelalbumin som berettigede.
Therefore, in view of the data presented in the reviewed PSUR(s), the PRAC considered that changes to the product information of medicinal products containing paclitaxel albumin were warranted.
Set i lyset af de data, der var til rådighed vedrørende hyponatriæmi, PRAC anså således ændringerne i produktinformationerne for at være nødvendige.
Therefore, in view of available data regarding hyponatremia, the PRAC considered that changes to the product information were warranted.
Set i lyset af de fremlagte data i de(n) gennemgåede PSUR(’er) er PRAC af den holdning, at det er berettiget at ændre produktinformationen til lægemidler, der indeholder sofosbuvir.
Therefore, in view of the data presented in the reviewed PSUR(s), the PRAC considered that changes to the product information of medicinal product(s) containing sofosbuvir were warranted.
Set i lyset af de præsenterede data i den evaluerede PSUR, vurderede PRAC derfor, at ændringer til produktinformationen for lægemidler, der indeholder trametinib, var påkrævet.
Therefore, in view of the data presented in the reviewed PSUR, the PRAC considered that changes to the product information of medicinal products containing trametinib were warranted.
Set i lyset af de præsenterede data i den reviderede PSUR anser PRAC ændringerne til produktresuméet for lægemidlerne indeholdende aclidiniumbromid/formoterolfumaratdihydrat for berettigede.
Therefore, in view of the data presented in the reviewed PSUR, the PRAC considered that changes to the product information of medicinal products containing aclidinium bromide/formoterol fumarate dihydrate were warranted.
Set i lyset af den aktuelle sikkerhedsprofil for Ranexa vurderede PRAC desuden, at PSUR- cyklussen skulle udvides fra to til tre år.
In addition, in view of the current safety profile of Ranexa the PRAC considered that the PSUR cycle should be extended from 2 years to 3 years.
Set i lyset af denne information vurderer PRAC, at det er acceptabelt at "anafylaktisk reaktion" (med frekvensen "ikke kendt") tilføjes til punkt 4.8 i produktresuméet for aclidiniumbromid/formoterolfumaratdihydrat.
Considering this information, the PRAC considers acceptable that ‘anaphylactic reaction,’ (with a frequency of ‘not known’) is added to section 4.8 of the SmPC for aclidinium bromide/formoterol fumarate dihydrate.
Set i lyset af tilgængelige data for liraglutid, vurderede PRAC at ændringer til produktresuméet derfor var påkrævet.
Therefore, in view of the data presented in the reviewed PSUR, the PRAC considered that changes to the product information of medicinal products containing liraglutide were warranted
Set i lyset af tilgænggelig data for vildagliptin og vildagliptin/metformin har PRAC konkluderet, at der er behov for ændringer i produktresuméet.
Therefore, in view of available data regarding vildagliptin and vildagliptin/metformin, the PRAC considered that changes to the product information were warranted.
Set i sammenhæng indikerede disse resultater, at vaccinen ville være effektiv til at beskytte mod infektion med disse HPV- typer, når den blev givet fra niårsalderen, og at to-dosis vaccinationen er egnet til personer i alderen 9-14 år.
Taken together these results suggested that the vaccine would be effective at protecting from infection with these HPV types when given from 9 years of age, and that a two-dose vaccination is suitable in those aged 9 to 14.
SET og RESET fastlagde varighed og tidspunkt for søvn om natten og lur i dagtimerne via dagbog ført af patienten.
SET and RESET evaluated the duration and timing of nighttime sleep and daytime naps via patient-recorded diaries.
SET og RESET viste, at tasimelteon er effektivt til behandling af kliniske symptomer, herunder søvn-vågen døgnrytme og global klinisk funktion, hos patienter med Non-24 (tabel 3).
The effectiveness of tasimelteon in the treatment of clinical symptoms, including the circadian sleep-wake cycle and clinical global functioning in patients with Non-24 was established in SET and RESET (Table 3).
Set ud fra et mikrobielt synspunkt skal lægemidlet anvendes omgående.
From a microbiological point of view, the medicinal product should be used immediately.
Set ud fra et mikrobiologisk synspunkt bør der opløste produkt anvendes øjeblikkeligt.
From a microbiological point of view, the diluted product should be used immediately.
Set ud fra et mikrobiologisk synspunkt skal produktet bruges straks.
From a microbiological point of view, the reconstituted product should be used immediately.
SET-undersøgelsen
SET Study
Sevaron s.r.o.
ECO Animal Health Ltd,
Sevelamer carbonate Zentiva 2,4 g pulver til oral suspension sevelamercarbonat
Sevelamer carbonate Zentiva 2.4 g powder for oral suspension sevelamer carbonate
Sevelamer carbonate Zentiva 2,4 g pulver til oral suspension.
Sevelamer carbonate Zentiva 2.4 g powder for oral suspension
Sevelamer carbonate Zentiva 800 mg filmovertrukne tabletter
Sevelamer carbonate Zentiva 800 mg film-coated tablets
Sevelamer carbonate Zentiva 800 mg filmovertrukne tabletter sevelamercarbonat
Sevelamer carbonate Zentiva 800 mg film-coated tablets sevelamer carbonate
Sevelamer carbonate Zentiva absorberes ikke og kan påvirke biotilgængeligheden af andre lægemidler.
Sevelamer carbonate Zentiva is not absorbed and may affect the bioavailability of other medicinal products.
Sevelamer carbonate Zentiva absorberes ikke og kan påvirke biotilgængeligheden af andre lægemidler.
Sevelamer carbonate Zentiva is not absorbed compound and may affect the bioavailability of other medicinal products.
Sevelamer carbonate Zentiva anvendes til kontrol af hyperfosfatæmi (forhøjet fosfat niveauer) hos: voksne patienter i dialyse (en blodrensningsteknik).
Sevelamer carbonate Zentiva is used to control hyperphosphataemia (high blood phosphate levels) in: adult patients on dialysis (a blood clearance technique).
Sevelamer carbonate Zentiva bør anvendes i forbindelse med flere andre behandlinger, der kan omfatte ekstra tilførsel af kalcium, 1,25 - dihydroxy vitamin D3 eller et af dettes analoge stoffer til styring af udviklingen af renal knoglesygdom.
Sevelamer carbonate Zentiva should be used within the context of a multiple therapeutic approach, which could include calcium supplement, 1,25-dihydroxy Vitamin D3 or one of its analogues to control the development of renal bone disease.
Sevelamer carbonate Zentiva bør anvendes sammen med andre behandlinger såsom tilskud af calcium og vitamin D for at forebygge knoglesygdom.
Sevelamer carbonate Zentiva should be used with other treatments such as calcium supplements and vitamin D to prevent the development of bone disease.
Sevelamer carbonate Zentiva bør kun anvendes på tvingende indikation til gravide og kun efter udførelse af en omhyggelig risk-benefit-analyse for både mor og foster.
Sevelamer carbonate Zentiva should only be given to pregnant women if clearly needed and after a careful risk/benefit analysis has been conducted for both the mother and the foetus.
Sevelamer carbonate Zentiva bør kun anvendes på tvingende indikation til gravide, og kun efter udførelse af en omhyggelig risk-benefit-analyse for både mor og foster.
Sevelamer carbonate Zentiva should only be given to pregnant women if clearly needed and after a careful risk/benefit analysis has been conducted for both the mother and the foetus.
Sevelamer carbonate Zentiva er ikke indiceret til kontrol af hyperparathyroidisme.
Sevelamer carbonate Zentiva is not indicated for the control of hyperparathyroidism.
Sevelamer carbonate Zentiva er indiceret til kontrol af hyperphosphatæmi hos voksne patienter, der er i hæmodialyse eller peritonealdialyse.
Sevelamer carbonate Zentiva is indicated for the control of hyperphosphataemia in adult patients receiving haemodialysis or peritoneal dialysis.
Sevelamer carbonate Zentiva er indiceret til kontrol af hyperphosphatæmi hos voksne patienter, som er i hæmodialyse eller peritonealdialyse.
Sevelamer carbonate Zentiva is indicated for the control of hyperphosphataemia in adult patients receiving haemodialysis or peritoneal dialysis.
Sevelamer carbonate Zentiva er også indiceret til kontrol af hyperphosphatæmi hos patienter med kronisk nyresygdom, som ikke er i dialyse, men har et indhold af serumphosphat > 1,78 mmol/L.
Sevelamer carbonate Zentiva is also indicated for the control of hyperphosphataemia in adult patients with chronic kidney disease patients not on dialysis with serum phosphorus > 1.78 mmol/L.
Sevelamer carbonate Zentiva er også indiceret til kontrol af hyperphosphatæmi hos voksne patienter med kronisk nyresygdom, som ikke er i dialyse, men har et indhold af serumphosphat > 1,78 mmol/L.
Sevelamer carbonate Zentiva is also indicated for the control of hyperphosphataemia in adult patients with chronic kidney disease not on dialysis with serum phosphorus > 1.78 mmol/L.
Sevelamer carbonate Zentiva filmovertrukne tabletter er hvide og har SC800 trykt på den ene side.
Sevelamer carbonate Zentiva film-coated tablets are white tablets with SC800 imprinted on one side.
Sevelamer carbonate Zentiva fås som tabletter (800 mg) og som pulver (2,4 g) til fremstilling af en opslæmning (suspension), der indtages gennem munden.
Sevelamer carbonate Zentiva is available as tablets (800 mg) and as a powder (2.4 g) to be made up into a suspension to be taken by mouth.
Sevelamer carbonate Zentiva indeholder det aktive stof sevelamerkarbonat.
Sevelamer carbonate Zentiva contains the active substance sevelamer carbonate.
Sevelamer carbonate Zentiva indeholder ikke kalcium.
Sevelamer carbonate Zentiva does not contain any calcium.
Sevelamer carbonate Zentiva indeholder sevelamer, en ikke-absorberbar phosphatbindende krydsbunden polymer uden metal og kalcium.
Sevelamer carbonate Zentiva contains sevelamer, a non-absorbed phosphate binding crosslinked polymer, free of metal and calcium.
Sevelamer carbonate Zentiva må ikke anvendes hos personer med for lavt fosfatindhold i blodet (hypofosfatæmi) eller tarmslyng (ileus).
Sevelamer carbonate Zentiva must not be used in people with hypophosphataemia (low blood phosphate levels) or with bowel obstruction (a blockage in the gut).
Sevelamer carbonate Zentiva må ikke tages på samme tid som ciprofloxacin (antibiotikum).
Sevelamer carbonate Zentiva should not be taken at the same time as ciprofloxacin (an antibiotic).
Sevelamer carbonate Zentiva pulver til oral suspension skal tages tre gange dagligt sammen med måltider.
Sevelamer carbonate Zentiva powder for oral suspension must be taken three times per day with meals.
Sevelamer carbonate Zentiva sevelamerkarbonat
Sevelamer carbonate Zentiva sevelamer carbonate
Sevelamer carbonate Zentiva skal anvendes med andre behandlinger såsom calciumtilskud og D-vitamin for at forhindre udviklingen af knoglesygdom.
Sevelamer carbonate Zentiva should be used with other treatments such as calcium supplements and vitamin D to prevent the development of bone disease.
Sevelamer carbonate Zentiva skal tages tre gange dagligt sammen med måltider, og patienterne skal holde den ordinerede diæt
Sevelamer carbonate Zentiva must be taken three times a day with meals and patients should keep to their prescribed diets.
Sevelamer carbonate Zentiva skal tages tre gange dagligt sammen med måltider.
Sevelamer carbonate Zentiva must be taken three times per day with meals.
Sevelamer hydrochlorid hæmmede ikke fertiliteten hos han- eller hunrotter i et diætadministrationsstudie, hvor behandling af hunrotterne varede fra 14 dage inden parring og hele gestationen, og hanrotterne blev behandlet i 28 dage inden parring.
Sevelamer hydrochloride did not impair the fertility of male or female rats in a dietary administration study in which the females were treated from 14 days prior to mating through gestation and the males were treated for 28 days prior to mating.
Sevelamer hydrochlorid var ikke mutagen i Ames bakterielle mutationsanalyse.
Sevelamer hydrochloride was not mutagenic in the Ames bacterial mutation assay.
Sevelamer hydrochlorid, der indeholder samme aktive fragment som sevelamercarbonat, absorberes ikke fra gastrointestinalkanalen, hvilket er bekræftet i et absorptionsstudie med raske frivillige.
Sevelamer hydrochloride, which contains the same active moiety as sevelamer carbonate, is not absorbed from the gastrointestinal tract, as confirmed by an absorption study in healthy volunteers.
Sevelamer hydrochlorid, der indeholder samme aktive fragment som sevelamercarbonat, er blevet indgivet til normale, raske frivillige i doser på op til 14 gram dagligt i otte dage uden bivirkninger.
Sevelamer hydrochloride, which contains the same active moiety as sevelamer carbonate, has been given to normal healthy volunteers in doses of up to 14 grams per day for eight days with no undesirable effects.
Sevelamer indeholder adskillige aminer adskilt af et karbon fra polymerens backbone, som protoneres i maven.
Sevelamer contains multiple amines separated by one carbon from the polymer backbone which become protonated in the stomach.
Sevelamer indeholder ikke kalcium og reducerer incidensen af episoder med hyperkalcæmi sammenlignet med patienter, der kun tager kalciumbaserede phosphatbindere.
Sevelamer does not contain calcium and decreases the incidence of hypercalcaemic episodes as compared to patients using calcium based phosphate binders alone.
Sevelamer: Co-administration af sevelamer (2.400 mg 3 gange dagligt) påvirkede ikke de farmakokinetiske egenskaber af cinacalcet.
Sevelamer: Co-administration of sevelamer (2400 mg tid) did not affect the pharmacokinetics of cinacalcet.
Sevelamer: Co-administration af sevelamer (2.400 mg 3 gange dagligt) påvirkede ikke de farmakokinetiske egenskaber af cinacalcet.
Sevelamer: Co-administration of sevelamer (2400 mg, three times a day) did not affect the pharmacokinetics of cinacalcet.
Sevelamercarbonat
carbonate
Sevelamercarbonat behandling skal reevalueres hos patienter, som udvikler svære gastrointestinale symptomer.
Sevelamer carbonate treatment should be re-evaluated in patients who develop severe gastrointestinal symptoms.
Sevelamerhydrochlorid, der indeholder samme aktive fragment som sevelamercarbonat, er blevet indgivet til normale, raske frivillige i doser på op til 14 gram dagligt i otte dage uden bivirkninger.
Sevelamer hydrochloride, which contains the same active moiety as sevelamer carbonate, has been given to normal healthy volunteers in doses of up to 14 grams per day for eight days with no undesirable effects.
Sevelamers ikke- absorberede egenskaber indikerer, at sevelamer sandsynligvis ikke udskilles i brystmælk.
The non-absorbed nature of sevelamer indicates that excretion of sevelamer in breast milk is unlikely.
SevoFlo 100% væske til inhalationsdamp til hunde sevofluran
SevoFlo 100% Inhalation vapour, liquid for dogs. sevoflurane
SevoFlo 100% væske til inhalationsdamp til hunde. sevofluran
SevoFlo 100% Inhalation vapour, liquid for dogs. sevoflurane
SevoFlo 100%. væske til inhalationsdamp til hunde
SevoFlo 100% Inhalation vapour, liquid for dogs.
SevoFlo anvendes til at fremkalde og vedligeholde fuld bedøvelse (bevidstløshed) hos hunde.
SevoFlo is used both to cause and maintain general anaesthesia (loss of consciousness) in dogs.
SevoFlo anvendes til fuld bedøvelse af hunde.
SevoFlo is a general anaesthetic for dogs.
SevoFlo bør indgives via en fordamper, der er kalibreret specifikt til anvendelse med sevofluran, således at den givne koncentration kan kontrolleres nøjagtigt.
SevoFlo should be administered via a vaporiser specifically calibrated for use with sevoflurane so that the concentration delivered can be accurately controlled.
SevoFlo gives ved hjælp af et specielt bedøvelsesapparat, normalt i en nøje kontrolleret blanding med ilt.
SevoFlo is given using specialised anaesthetic equipment, usually in a carefully controlled gas mixture including oxygen.
SevoFlo indeholder ingen stabilisator o påvirker ikke på nogen måde kalibreringen eller funktionen af disse fordampere.
SevoFlo contains no stabiliser and does not affect the calibration or operation of these vaporisers in any way.
SevoFlo må ikke gives til drægtige eller diegivende tæver.
SevoFlo must not be given to pregnant or lactating bitches.
SevoFlo sevofluran
SevoFlo sevoflurane
SevoFlo skal tilføres via en fordamper, der er kalibreret specifikt til anvendelse med sevofluran, således at den givne koncentration kan kontrolleres nøjagtigt.
SevoFlo should be administered via a vaporiser specifically calibrated for use with sevoflurane so that the concentration delivered can be accurately controlled.
SevoFlo udleveres i papkarton indeholdende en 250 ml polyetylennafthalat (PEN)-flaske med Quik- Fil-låg.
SevoFlo is presented in a cardboard box containing a 250 ml polyethylene naphthalate (PEN) bottle with a Quik-Fil closure.
Sevofluran 100% v/v
Sevoflurane 100% v/v.
Sevofluran 100% v/v.
100% v/v sevoflurane
Sevofluran 100% v/v.
Sevoflurane 100% v/v
Sevofluran binder og blokerer desuden receptorer for glutamat, som er et stof, der øger den elektriske aktivitet i hjernen.
Sevoflurane also binds and blocks receptors for glutamate which is a
Sevofluran fremkalder systemisk vasodilatation og medfører dosisafhængige fald i det arterielle middelblodtryk, total perifer modstand, hjertets minutvolumen og muligvis i myokardiets kontraktionsstyrke og relakseringshastighed.
Sevoflurane causes systemic vasodilation and produces dose dependent decreases in mean arterial pressure, total peripheral resistance, cardiac output and possibly the strength of myocardial contraction and speed of myocardial relaxation.
Sevofluran fremkalder systemisk vasodilatation og medfører dosisafhængige fald i det arterielle middelblodtryk, total perifer modstand, hjertets minutvolumen og muligvis i myokardiets kontraktionsstyrke og relakseringshastighed.
Sevoflurane causes systemic vasodilation and produces dose- dependent decreases in mean arterial pressure, total peripheral resistance, cardiac output and possibly the strength of myocardial contraction and speed of myocardial relaxation.
Sevofluran har en varierende virkning på hjertefrekvensen, som har en tendens til at øge fra udgangspunktet ved lav MAC og gå ned ved øgende MAC.
Sevoflurane has a variable effect on heart rate, which tends to increase from baseline at low MAC and fall back with increasing MAC.
Sevofluran kan anvendes til vedligeholdelse af anæstesi efter maskeindledning med sevofluran eller efter indledning med stoffer, der injiceres.
Sevoflurane may be used for maintenance anaesthesia following mask induction using sevoflurane or following induction with injectable agents.
Sevofluran kan forårsage en lille stigning i det intrakranielle tryk (ICP) under normokapniske omstændigheder.
Sevoflurane may cause a small increase in intracranial pressure (ICP) under conditions of normocapnia.
Sevofluran kan hos følsomme hunde udløse episoder med malign hypertermi.
Sevoflurane may trigger episodes of malignant hyperthermia in susceptible dogs.
Sevofluran kan ved normalt partialtryk af kuldioksid (normokapni), øge det intrakranielle tryk ved koncentrationer på 2,0 MAC og derovermen det er vist, at det intrakranielle tryk forbliver indenfor normalområdet ved sevoflurankoncentrationer på op til 1,5 MAC, hvis der etableres hypokapni ved hjælp af hyperventilation.
Sevoflurane may increase intracranial pressure at concentrations of 2.0 MAC and above under normal partial pressures of carbon dioxide (normocapnia), but intracranial pressure has been shown to remain within normal range at sevoflurane concentrations of up to 1.5 MAC if hypocapnia is induced by hyperventilation.
Sevofluran påvirker autoregulationen af den renale gennemblødning hos hunde i ugunstig retning.
Sevoflurane administration adversely affects the autoregulation of renal blood flow in dogs.
Sevoflurankoncentrationer under 2,0 MAC resulterer i en lille netto forøgelse af den totale levergennemblødning.
Concentrations of sevoflurane below 2.0 MAC result in a small net increase in total liver blood flow.
Sevohale 100% v/v væske til inhalationsdamp til hunde
Sevohale 100% v/v Inhalation vapour, liquid for dogs.