FrancophonIA/ELRC3.0 huggingface dataset:
English: Edistride has not been studied in severe renal impairment (CrCl < 30 ml/min or eGFR < 30 ml/min/1.73 m 2) or end-stage renal disease (ESRD).
Danish: Edistride er ikke blevet undersøgt ved svært nedsat nyrefunktion (CrCl < 30 ml/min eller eGFR < 30 ml/min/1,73 m 2) eller ved terminal nyresygdom (ESRD).
English: At Week 48 when added to sitagliptin (with or without metformin), the adjusted mean change from baseline for dapagliflozin 10 mg and placebo was -0.30 % and 0.38 %, respectively.
Danish: I uge 48 ved kombination med sitagliptin (med eller uden metformin) var den justerede gennemsnitlige ændring fra baseline for dapagliflozin 10 mg og placebo henholdsvis -0,30 % og 0,38 %.
English: Thirteen double-blind, randomised, controlled clinical trials were conducted with 6,362 subjects with type 2 diabetes to evaluate the efficacy and safety of Edistride; 4,273 subjects in these studies were treated with dapagliflozin.
Danish: Der blev udført tretten dobbeltblinde, randomiserede, kontrollerede kliniske studier med 6.362 forsøgspersoner med type 2-diabetes for at vurdere Edistrides sikkerhed og virkning.
English: Effect of dapagliflozin on other medicinal products In interaction studies conducted in healthy subjects, using mainly a single-dose design, dapagliflozin did not alter the pharmacokinetics of metformin, pioglitazone, sitagliptin, glimepiride, hydrochlorothiazide, bumetanide, valsartan, digoxin (a P-gp substrate) or warfarin (S-warfarin, a CYP2C9 substrate), or the anticoagulatory effects of warfarin as measured by INR.
Danish: I interaktionsstudier med raske forsøgspersoner hovedsageligt med enkeltdosisdesign ændrede dapagliflozin ikke farmakokinetikken af metformin, pioglitazon, sitagliptin, glimepirid, hydrochlorthiazid, bumetanid, valsartan, digoxin (et P-gp-substrat) eller warfarin (S-warfarin, et CYP2C9-substrat) eller de antikoagulerende virkninger af warfarin, målt ud fra INR-værdi.
English: a) in an active-controlled study comparing dapagliflozin to glipizide as add-on to metformin
Danish: a) i et aktivt kontrolleret studie, der havde til formål at sammenligne dapagliflozin med glipizid som tillægsbehandling til metformin
English: In a pre-specified analysis of subjects with baseline HbA1c ≥ 9.0 %, treatment with dapagliflozin 10 mg resulted in statistically significant reductions in HbA1c at Week 24 as a monotherapy (adjusted mean change from baseline: -2.04 % and 0.19 % for dapagliflozin 10 mg and placebo, respectively) and as an add-on to metformin (adjusted mean change from baseline: -1.32 % and -0.53 % for dapagliflozin and placebo, respectively).
Danish: I en præspecificeret analyse af forsøgspersoner med HbA1c ≥ 9,0 % ved baseline resulterede behandling med dapagliflozin 10 mg som monoterapi, i statistisk signifikante reduktioner af HbA1c i uge 24 (justeret gennemsnitlig ændring fra baseline: -2,04 % og 0,19 % for henholdsvis dapagliflozin 10 mg og placebo) og som tillægsbehandling til metformin (justeret gennemsnitlig ændringer fra baseline: -1,32 % og -0,53 % for henholdsvis dapagliflozin og placebo).
English: Urinary tract infections were more frequently reported for dapagliflozin 10 mg compared to placebo in a pooled analysis up to 24 weeks (see section 4.8).
Danish: Der blev rapporteret om hyppigere urinvejsinfektioner ved dapagliflozin 10 mg sammenlignet med placebo i en puljet analyse på op til 24 uger (se pkt.
English: Results of 24-week (LOCF
Danish: Resultater af 24-ugers (LOCF
English: The mean change from baseline in HbA1c at 24 weeks was -0.44 % and -0.33 %, for dapagliflozin 10 mg and placebo, respectively.
Danish: Den gennemsnitlige ændring fra baseline i HbA1c efter 24 uger var henholdsvis -0,44 % og -0,33 % for dapagliflozin 10 mg og placebo.
English: This grouping of reactions was reported in 3.2 % and 1.8 % of patients who received dapagliflozin 10 mg and placebo, respectively.
Danish: Denne type bivirkninger blev rapporteret hos 3,2 % og 1,8 % af patienter, der fik dapagliflozin 10 mg hhv.
English: LOCF: Last observation (prior to or on the date of the first insulin up-titration, if needed) carried forward All randomised subjects who took at least one dose of double-blind study medicinal product during the shortterm double-blind period Least squares mean adjusted for baseline value and presence of oral glucose-lowering medicinal product p-value < 0.0001 versus placebo + insulin ± oral glucose-lowering medicinal product p-value < 0.05 versus placebo + insulin ± oral glucose-lowering medicinal product Up-titration of insulin regimens (including short-acting, intermediate, and basal insulin) was only allowed if subjects met pre-defined FPG criteria.
Danish: LOCF: Last Observation Carried Forward (før eller på datoen for den første optitrering af insulin, hvis nødvendigt) Alle randomiserede forsøgspersoner, som tog mindst én dosis af lægemidlet i den dobbeltblinde periode i korttidsstudierne Gennemsnit beregnet efter mindste kvadraters metode justeret for baselineværdi og tilstedeværelse af oralt glucosesænkende lægemiddel p-værdi < 0,0001 versus placebo + insulin ± oralt glucosesænkende lægemiddel p-værdi < 0,05 versus placebo + insulin ± oralt glucosesænkende lægemiddel Optitrering af insulinregimer (inklusive korttidsvirkende, mellemtidsvirkende og basal insulin) var kun tilladt, hvis forsøgspersonerne opfyldte de foruddefinerede FPG-kriterier.
English: • The other ingredients are:
Danish: Anbefalingen fremsættes ud fra følgende betragtninger:
English: film-coating: polyvinyl alcohol (E1203), titanium dioxide (E171), macrogol 3350, talc (E553b),
Danish: filmovertræk: polyvinylalkohol (E1203), titandioxid (E171), macrogol 3350, talkum (E553b), gul jernoxid (E172).
English: In patients with normal renal function or mild renal impairment (baseline eGFR ≥ 60 ml/min/1.73 m2) this grouping of reactions were reported in 1.3 % and 0.8 % of patients who received dapagliflozin 10 mg and placebo, respectively.
Danish: Hos patienter med normal eller let nedsat nyrefunktion (baseline eGRF ≥ 60 ml/min/1,73m blev denne type bivirkninger set hos 1,3 % og 0,8 % af patienter, der fik dapagliflozin 10 mg hhv. placebo.
English: Edistride is not recommended for use in patients with moderate to severe renal impairment (patients with CrCl < 60 ml/min or eGFR < 60 ml/min/1.73 m2).
Danish: Edistride bør ikke anvendes til patienter med moderat til svært nedsat nyrefunktion (patienter med CrCl < 60 ml/min eller eGFR < 60 ml/min/1,73 m 2).
English: (95 % CI) Subjects (%) achieving: HbA1c < 7 % (LOCF) Adjusted for baseline Body weight (kg) (LOCF) Baseline (mean) Change from baseline Difference from placebo c
Danish: (95 % CI) Forsøgspersoner (%) der opnåede: HbA1c < 7 % (LOCF) Justeret for baseline Legemsvægt (kg) (LOCF) Baseline (gennemsnitlig) Ændring fra baseline Forskel fra placebo c
English: At Week 208, adjusted mean change from baseline in HbA1c was -0.10 % for dapagliflozin and 0.20 % for glipizide.
Danish: I uge 208 var den justerede gennemsnitlige ændring i HbA1c i forhold til baseline -0,10 % for dapagliflozin og 0,20 % for glipizid.
English: In an add-on to insulin study, episodes of major hypoglycaemia were reported in 0.5 % and 1.0 % of subjects treated with dapagliflozin 10 mg plus insulin at Weeks 24 and 104, respectively, and in 0.5 % of subjects treated with placebo plus insulin groups at Weeks 24 and 104.
Danish: I et studie med tillægsbehandling til insulin blev der rapporteret om tilfælde af svær hypoglykæmi hos 0,5 % og 1,0 % af de forsøgspersoner, som fik dapagliflozin 10 mg og insulin, i henholdsvis uge 24 og 104, og hos 0,5 % af de forsøgspersoner, som fik placebo og insulin, i uge 24 og 104.
English: Reported in ≥ 2 % of subjects and ≥ 1 % more and at least 3 more subjects treated with dapagliflozin 10 mg compared to placebo.
Danish: 4.4 *Rapporteret hos ≥ 2 % af forsøgspersonerne og hos ≥ 1 % flere og mindst 3 forsøgspersoner flere behandlet med dapagliflozin 10 mg end med placebo.
English: At Week 104, adjusted mean change from baseline in HbA1c was -0.32 % for dapagliflozin and -0.14 % for glipizide.
Danish: I uge 104 var den justerede gennemsnitlige ændring i HbA1c fra baseline -0,32 % for dapagliflozin og -0,14 % for glipizid.
English: For the add-on to metformin study, HbA1c reductions were sustained through Week 102 (-0.78 % and 0.02 % adjusted mean change from baseline for 10 mg and placebo, respectively).
Danish: I studiet med tillægsbehandling til metformin var reduktionen i HbA1c vedvarende til og med uge 102 (-0,78 % og 0,02 % justeret gennemsnitlig ændring fra baseline for henholdsvis 10 mg og placebo).
English: At Week 104 for insulin (with or without additional oral glucose-lowering medicinal products), the HbA1c reductions were -0.71 % and -0.06 % adjusted mean change from baseline for dapagliflozin 10 mg and placebo, respectively.
Danish: I uge 104 var reduktionen i HbA1c ved insulin (med eller uden tillæg af oral glucosesænkende medicin) -0,71 % og -0,06 % justeret gennemsnitlig ændring fra baseline for henholdsvis dapagliflozin 10 mg og placebo.
English: In subjects ≥ 65 years of age, adverse reactions of volume depletion, most commonly reported as hypotension, were reported in 1.7 % and 0.8 % of dapagliflozin-treated subjects and placebo-treated subjects, respectively (see section 4.4).
Danish: Hos forsøgspersoner ≥ 65 år blev der rapporteret bivirkninger i form af volumedepletering, der almindeligvis viste sig som hypotension, hos 1,7 % og 0,8 % af de forsøgspersoner, der fik henholdsvis dapagliflozin og placebo (se pkt.
English: Excipient with known effect: Each 10 mg tablet contains 50 mg of lactose anhydrous.
Danish: Hjælpestof, som behandleren skal være opmærksom på: Hver 10 mg tablet indeholder 50 mg vandfri lactose.
English: In the extension period, HbA1c reductions were sustained through Week 102 (-0.61 %, and -0.17 % adjusted mean change from baseline for dapagliflozin 10 mg and placebo, respectively).
Danish: HbA1c-reduktionen var opretholdt i op til 102 uger (-0,61 %, og -0,17 % justeret gennemsnitlig ændring fra baseline for henholdsvis dapagliflozin 10 mg og placebo).
English: Reactions related to volume depletion (including, reports of dehydration, hypovolaemia or hypotension) were reported in 1.1 % and 0.7 % of subjects who received dapagliflozin 10 mg and placebo, respectively; serious reactions occurred in < 0.2 % of subjects balanced between dapagliflozin 10 mg and placebo (see section 4.4).
Danish: Bivirkninger relateret tilvolumendepletering (inklusive indberetninger om dehydrering, hypovolæmi eller hypotension) blev rapporteret hos 1,1 % og 0,7 % af forsøgspersoner, som fik behandling med henholdsvis dapagliflozin 10 mg og placebo.
English: Edistride 5 mg film-coated tablets EU/1/15/1052/001 14 film-coated tablets EU/1/15/1052/002 28 film-coated tablets EU/1/15/1052/003 98 film-coated tablets EU/1/15/1052/004 30 x 1 (unit dose) film-coated tablets EU/1/12/1052/005 90 x 1 (unit dose) film-coated tablets
Danish: Edistride 5 mg filmovertrukne tabletter EU/1/15/1052/001 14 filmovertrukne tabletter EU/1/15/1052/002 28 filmovertrukne tabletter EU/1/15/1052/003 98 filmovertrukne tabletter EU/1/15/1052/004 30 x 1 (enkeltdosis) filmovertrukne tabletter EU/1/15/1052/005 90 x 1 (enkeltdosis) filmovertrukne tabletter
English: Microcrystalline cellulose (E460i) Lactose, anhydrous Crospovidone (E1202) Silicon dioxide (E551) Magnesium stearate (E470b)
Danish: Crospovidon (E1202) Siliciumdioxid (E551) Magnesiumstearat (E470b)
English: Edistride is not recommended for use in patients with moderate to severe renal impairment (patients with creatinine clearance [CrCl] < 60 ml/min or estimated glomerular filtration rate [eGFR] < 60 ml/min/1.73 m2, see sections 4.4, 4.8, 5.1 and 5.2).
Danish: Edistride bør ikke anvendes til patienter med moderat til svært nedsat nyrefunktion (patienter med kreatininclearance [CrCl] < 60 ml/min eller estimeret glomerulær filtrationshastighed [eGFR] < 60 ml/min/1,73 m2 (se pkt.
English: Metformin ≥ 1500 mg/day; sitagliptin 100 mg/day LOCF: Last observation (prior to rescue for rescued subjects) carried forward All randomised subjects who took at least one dose of double-blind study medicinal product during the short-term double-blind period Least squares mean adjusted for baseline value p-value < 0.0001 versus placebo + oral glucose-lowering medicinal product p-value < 0.05 versus placebo + oral glucose-lowering medicinal product
Danish: 2sitagliptin 100 mg/dag LOCF: Last observation carried forward (før behandling med rescue-medicin) Alle randomiserede forsøgspersoner, som tog mindst én dosis af den dobbeltblinde studiemedicin i den dobbeltblinde periode i korttidsstudierne Gennemsnit beregnet efter mindste kvadraters metode justeret for baselineværdi p-værdi < 0,0001 versus placebo + oralt glucosesænkende lægemiddel p-værdi < 0,05 versus placebo + oralt glucosesænkende lægemiddel
English: Edistride 10 mg film-coated tablets EU/1/15/1052/006 14 film-coated tablets EU/1/15/1052/007 28 film-coated tablets EU/1/15/1052/008 98 film-coated tablets EU/1/15/1052/009 30 x 1 (unit dose) film-coated tablets EU/1/15/1052/010 90 x 1 (unit dose) film-coated tablets
Danish: Edistride 10 mg filmovertrukne tabletter EU/1/15/1052/006 14 filmovertrukne tabletter EU/1/15/1052/007 28 filmovertrukne tabletter EU/1/15/1052/008 98 filmovertrukne tabletter EU/1/15/1052/009 30 x 1 (enkeltdosis) filmovertrukne tabletter EU/1/15/1052/010 90 x 1 (enkeltdosis) filmovertrukne tabletter
English: Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicines.
Danish: Brug af anden medicin sammen med Edistride Fortæl det til lægen, apotekspersonalet eller sundhedspersonalet, hvis du bruger anden medicin, har gjort det for nylig eller påtænker at gøre det.
English: The hazard ratio comparing dapagliflozin to comparator was 0.79 (95 % Confidence interval [CI]: 0.58, 1.07), indicating that in this analysis Edistride is not associated with an increase in cardiovascular risk in patients with type 2 diabetes mellitus.
Danish: Hazard ratio for sammenligning af dapagliflozin med comparator var 0,79 (95 % konfidensinterval [CI]: 0,58, 1,07).
English: Dapagliflozin is not recommended for use in patients receiving loop diuretics (see section 4.5) or who are volume depleted, e.g. due to acute illness (such as gastrointestinal illness).
Danish: 4.5), eller som er volumendepleterede, f.eks. på grund af akut sygdom (såsom mave-tarm-sygdom).
English: Body weight (kg) Baseline (mean) Change from baseline Difference from placebo c
Danish: Legemsvægt (kg) Baseline (gennemsnitlig) Ændringer fra baseline Forskel fra placebo c
English: Results at Week 52 (LOCF
Danish: Tabel 3 Resultater ved uge 52 (LOCF
English: Non-inferior to glipizide + metformin p-value < 0.0001
Danish: Gennemsnit beregnet efter mindste kvadraters metode justeret for baselineværdi p-værdi < 0,0001 versus placebo
English: Edistride 5 mg film-coated tablets Edistride 10 mg film-coated tablets
Danish: Edistride 5 mg filmovertrukne tabletter Edistride 10 mg filmovertrukne tabletter
English: Edistride 5 mg film-coated tablets Edistride 10 mg film-coated tablets dapagliflozin
Danish: Edistride 5 mg filmovertrukne tabletter Edistride 10 mg filmovertrukne tabletter dapagliflozin
English: (95 % CI) Subjects (%) achieving: HbA1c < 7 % Adjusted for baseline Body weight (kg) Baseline (mean) Change from baseline Difference from placebo c
Danish: HbA1c (%) Baseline (gennemsnitlig) Ændring fra baseline Forskel fra placebo (95 % CI) Forsøgspersoner (%), der opnår: HbA1c < 7 % Justeret for baseline Legemsvægt (kg) Baseline (gennemsnitlig) Ændring fra baseline Forskel fra placebo (95 % CI)
English: Contact your doctor as soon as possible if you have any of the following side effects: Very common (may affect more than 1 in 10 people)
Danish: Kontakt snarest muligt din læge, hvis du får en af følgende bivirkninger:
English: Edistride 10 mg film-coated tablets Each tablet contains dapagliflozin propanediol monohydrate equivalent to 10 mg dapagliflozin.
Danish: Edistride 10 mg filmovertrukne tabletter Hver tablet indeholder dapagliflozinpropanediolmonohydrat svarende til 10 mg dapagliflozin.
English: Edistride 5 mg film-coated tablets Each tablet contains dapagliflozin propanediol monohydrate equivalent to 5 mg dapagliflozin.
Danish: Edistride 5 mg filmovertrukne tabletter Hver tablet indeholder dapagliflozinpropanediolmonohydrat svarende til 5 mg dapagliflozin.
English: LOCF: Last observation (prior to rescue for rescued subjects) carried forward All randomised subjects who took at least one dose of double-blind study medication during the short-term double-blind period Least squares mean adjusted for baseline value p-value < 0.0001 versus placebo Not evaluated for statistical significance as a result of the sequential testing procedure for secondary end points
Danish: LOCF: Last Observation Carried Forward (før behandling med rescue-medicin) Alle randomiserede forsøgspersoner, som tog mindst én dosis dobbeltblind forsøgsmedicin i den dobbeltblinde periode af korttidsstudierne
English: Each tablet contains dapagliflozin propanediol monohydrate equivalent to10 mg dapagliflozin.
Danish: Hver tablet indeholder dapagliflozinpropanediolmonohydrat svarende til 10 mg dapagliflozin.
English: (95 % CI) Subjects (%) achieving: HbA1c < 7 % Adjusted for baseline
Danish: HbA1c < 7 % Justeret for baseline
English: • A valid GMP compliance statement for the manufacturer of the absorbable collagen sponge (ACS), fulfilling the requirements set out in Article 46 of Directive 2001/83/EC.
Danish: • Et gyldigt certifikat om overensstemmelse med GMP for producenten af den resorberbare kollagensvamp (ACS) i overensstemmelse med kravene i artikel 46 i direktiv 2001/83/EF.
English: For the suspension to be lifted, the Marketing Authorisation Holder for InductOs shall ensure that the following condition is fulfilled:
Danish: For at suspenderingen kan ophæves, skal indehaveren af markedsføringstilladelsen for InductOs sikre, at følgende betingelser er opfyldt:
English: Annex II Conditions for lifting the suspension of the marketing authorisation(s)
Danish: Bilag II Begrundelse for hævelse af suspenderingen af markedsføringstilladelsen/tilladelserne
English: Conditions for lifting the suspension of the marketing authorisation(s)
Danish: Begrundelse for hævelse af suspenderingen af markedsføringstilladelsen/tilladelserne
English: The full EPAR and risk management plan summary for Pemetrexed Hospira can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR og resuméet af risikostyringsplanen for Pemetrexed Hospira findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: This is a summary of the European public assessment report (EPAR) for Pemetrexed Hospira.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Pemetrexed Hospira.
English: The Committee recommended that Pemetrexed Hospira be approved for use in the EU.
Danish: Udvalget anbefalede, at Pemetrexed Hospira godkendes til anvendelse i EU.
English: A risk management plan has been developed to ensure that Pemetrexed Hospira is used as safely as possible.
Danish: Der er udarbejdet en risikostyringsplan for at sikre, at Pemetrexed Hospira anvendes så sikkert som muligt.
English: This means that Pemetrexed Hospira is similar to a ‘reference medicine' already authorised in the European Union (EU) called Alimta.
Danish: Det betyder, at Pemetrexed Hospira svarer til et "referencelægemiddel", som allerede er godkendt i Den Europæiske Union (EU), og som hedder Alimta.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Pemetrexed Hospira has been shown to be comparable to Alimta.
Danish: Udvalget for Lægemidler til Mennesker (CHMP) konkluderede, at det i overensstemmelse med EU's krav er påvist, at Pemetrexed Hospira er sammenligneligt med Alimta.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Pemetrexed Hospira, including the appropriate precautions to be followed by healthcare professionals and patients.
Danish: På baggrund af denne er der anført sikkerhedsoplysninger i produktresuméet og indlægssedlen for Pemetrexed Hospira, herunder passende forholdsregler, som sundhedspersonale og patienter skal følge.
English: No additional studies were needed as Pemetrexed Hospira is a generic medicine that is given by infusion and contains the same active substance as the reference medicine, Alimta.
Danish: Der var ikke brug for yderligere undersøgelser, da Pemetrexed Hospira er et generisk lægemiddel, som gives ved infusion og indeholder samme aktive stof som referencelægemidlet Alimta.
English: What are the benefits and risks of Pemetrexed Hospira?
Danish: Hvilke fordele og risici er der forbundet med Pemetrexed Hospira?
English: Pemetrexed Hospira is a cancer medicine used to treat two types of lung cancer:
Danish: Pemetrexed Hospira er et kræftlægemiddel til behandling af to typer af lungekræft:
English: What is Pemetrexed Hospira and what is it used for?
Danish: Hvad er Pemetrexed Hospira, og hvad anvendes det til?
English: Pemetrexed Hospira is a ‘generic medicine'.
Danish: Pemetrexed Hospira er et "generisk lægemiddel".
English: What measures are being taken to ensure the safe and effective use of Pemetrexed Hospira?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Pemetrexed Hospira?
English: It is not intended to provide practical advice on how to use Pemetrexed Hospira.
Danish: Det er ikke en praktisk vejledning i, hvordan Pemetrexed Hospira bør anvendes.
English: Other information about Pemetrexed Hospira
Danish: Andre oplysninger om Pemetrexed Hospira
English: Pemetrexed Hospira contains the active substance pemetrexed.
Danish: Pemetrexed Hospira indeholder det aktive stof pemetrexed.
English: To reduce side effects, patients should take a corticosteroid (a type of medicine that reduces inflammation) and folic acid (a type of vitamin), and receive injections of vitamin B12 during treatment with Pemetrexed Hospira.
Danish: For at mindske bivirkningerne bør patienten få binyrebarkhormon (en type lægemiddel, der mindsker inflammation), folsyre (en type vitamin) og indsprøjtninger med vitamin B12 under behandlingen med Pemetrexed Hospira.
English: Because Pemetrexed Hospira is a generic medicine, its benefits and risks are taken as being the same as the reference medicine's.
Danish: Da Pemetrexed Hospira er et generisk lægemiddel, anses benefit/risk-forholdet for at være det samme som for referencelægemidlet.
English: For more information about treatment with Pemetrexed Hospira, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Pemetrexed Hospira, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: The active substance in Pemetrexed Hospira, pemetrexed, is a cytotoxic medicine (a medicine that kills cells that are dividing, such as cancer cells), which belongs to the group ‘antimetabolites'.
Danish: Det aktive stof i Pemetrexed Hospira, pemetrexed, er et vævsgiftigt (cytotoksisk) lægemiddel (dvs. det dræber celler, der deler sig, såsom kræftceller) i gruppen "antimetabolitter".
English: For practical information about using Pemetrexed Hospira, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Pemetrexed Hospira, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: Why is Pemetrexed Hospira approved?
Danish: Hvorfor er Pemetrexed Hospira blevet godkendt?
English: When Pemetrexed Hospira is given with cisplatin, an ‘anti-emetic' medicine (to prevent vomiting) and fluids (to prevent dehydration) should also be given before or after the cisplatin dose.
Danish: Når Pemetrexed Hospira gives sammen med cisplatin, bør der desuden før eller efter cisplatin gives medicin mod kvalme og opkastninger samt væsketilskud for at forhindre udtørring.