natgillin/translations-raw huggingface dataset:
Afoxolaner MERIAL 11 mg hund 2-4 kg Afoxolaner MERIAL 28 mg hund &gt; 4-10 kg Afoxolaner MERIAL 68 mg hund &gt; 10-25 kg Afoxolaner MERIAL 136 mg hund &gt; 25-50 kg afoxolaner.
Afoxolaner MERIAL 11 mg dogs 2-4 kg Afoxolaner MERIAL 28 mg dogs &gt; 4-10 kg Afoxolaner MERIAL 68 mg dogs &gt; 10-25 kg Afoxolaner MERIAL 136 mg dogs &gt; 25-50 kg afoxolaner
INDLÆGSSEDDEL: Afoxolaner MERIAL 11 mg tyggetabletter til hund 2-4 kg Afoxolaner MERIAL 28 mg tyggetabletter til hund &gt; 4-10 kg Afoxolaner MERIAL 68 mg tyggetabletter til hund &gt; 10-25 kg Afoxolaner MERIAL 136 mg tyggetabletter til hund &gt; 25-50 kg
PACKAGE LEAFLET: Afoxolaner MERIAL 11 mg chewable tablets for dogs 2-4 kg Afoxolaner MERIAL 28 mg chewable tablets for dogs &gt; 4-10 kg Afoxolaner MERIAL 68 mg chewable tablets for dogs &gt; 10-25 kg Afoxolaner MERIAL 136 mg chewable tablets for dogs &gt; 25-50 kg
Afoxolaner MERIAL 11 mg tyggetabletter til hund 2-4 kg Afoxolaner MERIAL 28 mg tyggetabletter til hund &gt; 4-10 kg Afoxolaner MERIAL 68 mg tyggetabletter til hund &gt; 10-25 kg Afoxolaner MERIAL 136 mg tyggetabletter til hund &gt; 25-50 kg afoxolaner
Afoxolaner MERIAL 11 mg chewable tablets for dogs 2-4 kg Afoxolaner MERIAL 28 mg chewable tablets for dogs &gt; 4-10 kg Afoxolaner MERIAL 68 mg chewable tablets for dogs &gt; 10-25 kg Afoxolaner MERIAL 136 mg chewable tablets for dogs &gt; 25-50 kg afoxolaner
Afoxolaner MERIAL 11 mg tyggetabletter til hund 2-4 kg Afoxolaner MERIAL 28 mg tyggetabletter til hund &gt; 4-10 kg Afoxolaner MERIAL 68 mg tyggetabletter til hund &gt; 10-25 kg Afoxolaner MERIAL 136 mg tyggetabletter til hund &gt; 25-50 kg
Afoxolaner MERIAL 11 mg chewable tablets for dogs 2-4 kg Afoxolaner MERIAL 28 mg chewable tablets for dogs &gt; 4-10 kg Afoxolaner MERIAL 68 mg chewable tablets for dogs &gt; 10-25 kg Afoxolaner MERIAL 136 mg chewable tablets for dogs &gt; 25-50 kg
Bivirkningerne er opdelt efter hyppighed med følgende betegnelser: Meget almindelig (≥1/10), almindelig (≥1/100 til &lt; 1/10), ikke almindelig (≥1/1.000 til &lt; 1/100), sjælden (≥1/10.000 til &lt; 1/1.000), meget sjælden ( &lt; 1/10.000).
Adverse reactions are ranked under headings of frequency using the following conventions: very common (≥1/10), common (≥1/100 to &lt; 1/10), uncommon (≥1/1,000 to &lt; 1/100), rare (≥1/10,000 to &lt; 1/1,000), very rare ( &lt; 1/10,000).
Forskellen mellem gennemsnitlig ændring fra baseline til uge 26/afslutning (LOCF, Last Observation Carried Forward) var statistisk signifikant (UPDRS, del I-III: forskellen mellem rasagilin 1 mg sammenlignet med placebo var 4,2, 95% CI [5,7; 2,7]; p &lt; 0,0001; forskellen mellem rasagilin 2 mg sammenlignet med placebo var 3,6, 95% CI [5,0; 2,1]; p &lt; 0,0001, UPDRS Motor, del II: forskellen mellem rasagilin 1 mg sammenlignet med placebo var 2,7; 95% CI [3,87; 1,55], p &lt; 0,0001; forskellen mellem rasagilin 2 mg sammenlignet med placebo var 1,68; 95% CI [2,85; 0,51], p=0,0050).
The difference between the mean change from baseline to week 26/termination (LOCF, Last Observation Carried Forward) was statistically significant (UPDRS, parts I-III: for rasagiline 1 mg compared to placebo -4.2, 95% CI [-5.7, -2.7]; p &lt; 0.0001; for rasagiline 2 mg compared to placebo -3.6, 95% CI [-5.0, -2.1]; p &lt; 0.0001, UPDRS Motor, part II: for rasagiline 1 mg compared to placebo -2.7, 95% CI [-3.87, -1.55], p &lt; 0.0001; for rasagiline 2 mg compared to placebo -1.68, 95% CI [-2.85, -0.51], p=0.0050).
Den gennemsnitlige totale reduktion i ”off” timer pr. dag var omtrent det samme i entakapongruppen (0,80 timer, 95% CI [1,20; 0,41], p &lt; 0,0001) som i rasagilin 1 mg gruppen.
The mean total daily decrease in the OFF time was similar in the entacapone group (-0.80h, 95% CI [-1.20, -0.41], p &lt; 0.0001) to that observed in the rasagiline 1 mg group.
I undersøgelse III var den gennemsnitlige forskel sammenlignet med placebo 0,94 timer, 95% CI [1,36; 0,51], p &lt; 0,0001.
In study III, the mean difference compared to placebo was -0.94h, 95% CI [-1.36, -0.51], p &lt; 0.0001.
Begrænsede data indikerer at farmakokinetikken for pegfilgrastim hos ældre forsøgspersoner ( 65 år) er tilsvarende den hos voksne.
Limited data indicate that the pharmacokinetics of pegfilgrastim in elderly subjects ( &gt; 65 years) is similar to that in adults.
Ristempas sikkerhed og virkning hos de novo AML-patienter &lt; 55 år med cytogenetik t(15;17) er ikke klarlagt.
The safety and efficacy of Ristempa administration in de novo AML patients aged  55 years with cytogenetics t(15;17) have not been established.
Der er rapporteret ikke almindelige ( 1/1.000 til &lt; 1/100) pulmonale bivirkninger, især interstitial pneumoni, efter administration af G-CSF.
Uncommon (≥1/1,000 to &lt; 1/100) pulmonary adverse reactions, in particular interstitial pneumonia, have been reported after G-CSF administration.
Reaktioner på injektionsstedet, herunder erytem (ikke almindelig (≥ 1/1.000 til &lt; 1/100)) og smerter (almindelig (≥ 1/100 til &lt; 1/10)) er set ved første behandling eller efterfølgende behandlinger med Ristempa.
Injection site reactions, including injection site erythaema (uncommon (≥ 1/1000 to &lt; 1/100)) as well as injection site pain (common events ≥ 1/100 to &lt; 1/10) have occurred on initial or subsequent treatment with Ristempa.
Overfølsomhedslignende reaktioner, herunder hududslæt, urticaria, angioødem, åndenød, erytem, flushing og hypotension, optrådte initialt og under vedligeholdelsesbehandling med Ristempa (ikke almindelig [≥ 1/1.000 til &lt; 1/100]).
Hypersensitivity-type reactions, including skin rash, urticaria, angioedema, dyspnoea, erythaema, flushing, and hypotension occurred on initial or subsequent treatment with Ristempa (uncommon [≥ 1/1,000 to &lt; 1/100]).
Incidensen af hospitalsindlæggelse og brugen af infektionshæmmende midler via IV forbundet med en klinisk diagnose af febril neutropeni var lavere i den gruppe, som fik pegfilgrastim, end i placebogruppen (1% imod 14%, p &lt; 0,001, og 2% imod 10%, p &lt; 0,001).
The incidence of hospitalisations and IV anti-infective use associated with a clinical diagnosis of febrile neutropenia was lower in the pegfilgrastim group compared with placebo (1% versus 14%, p  0.001; and 2% versus 10%, p  0.001).
Incidensen af febril neuropeni var lavere hos patienter, som var randomiseret til at få pegfilgrastim, end patienter i placebogruppen (1% imod 17%, p &lt; 0,001).
The incidence of febrile neutropenia was lower for patients randomised to receive pegfilgrastim compared with placebo (1% versus 17%, p &lt; 0.001).
I et randomiseret, åbent, fase II multicenterstudie (n = 37) med pædiatriske patienter med sarkom, som fik 100 μg pegfilgrastim/kg efter cyklus 1 kemoterapi med vincristin, doxorubicin og cyclophosphamid (VAdriaC/IE), blev der observeret længere varighed af svær neutropeni (neutrofiler &lt; 0,5 x 10
In a phase II (n = 37) multicentre, randomised, open-label study of paediatric sarcoma patients receiving 100 μg/kg pegfilgrastim following cycle 1 of vincristine, doxorubicin and cyclophosphamide (VAdriaC/IE) chemotherapy, a longer duration of severe neutropenia (neutrophils &lt; 0.5 x 10
Ikke almindelig (≥ 1/1.000 til &lt; 1/100)
Common (≥ 1/100 to &lt; 1/10)
Der er indberettet kapillærlækage-syndrom hos cancerpatienter, der fik kemoterapi efter indgift af granulocytkolonistimulerende faktor, med frekvensen ”ikke almindelige” (≥ 1/1000 til &lt; 1/100).
Capillary Leak Syndrome, which can be life-threatening if treatment is delayed, has been reported as uncommon (≥ 1/1,000 to &lt; 1/100) in cancer patients undergoing chemotherapy following administration of granulocyte colony-stimulating factors; see section 4.4 and section “Description of selected adverse reactions” below.
Der er indberettet leukocytose (WBC &gt; 100 x 10
Common (≥ 1/100 to &lt; 1/10) cases of leukocytosis (White Blood Count [WBC] &gt; 100 x 10
Infektioner, som generelt sÃ¦ttes i forbindelse med immunsuppression er iagttaget hos hunde.
Infections generally associated with immunosuppression were noted in dogs.
P-værdi: &lt; 0,0001 Odds ratio (ruxolitinib/BAT) og 95% CI:
P value: &lt; .0001 Odds ratio (ruxolitinib/BAT) and 95% CI:
Aktiverede mutationer i JAK2 (V617F eller exon 12) er fundet hos &gt; 95% af PV-patienter.
Activating mutations in JAK2 (V617F or exon 12) are found in &gt; 95% of PV patients.
Derudover er den tilsvarende frekvenskategori for hver bivirkning baseret på følgende konvention: meget almindelig (≥1/10); almindelig (≥1/100 til &lt; 1/10); ikke almindelig (≥1/1.000 til &lt; 1/100); sjælden (≥1/10.000 til &lt; 1/1.000); meget sjælden ( &lt; 1/10.000).
In addition, the corresponding frequency category for each adverse drug reaction is based on the following convention: very common (≥1/10); common (≥1/100 to &lt; 1/10); uncommon (≥1/1,000 to &lt; 1/100); rare (≥1/10,000 to &lt; 1/1,000); very rare ( &lt; 1/10,000).
Det er observeret, at patienter med lav trombocyttælling ( &lt; 200.000/mm 3) ved behandlingsstart med større sandsynlighed udvikler trombocytopeni under behandlingen.
It has been observed that patients with low platelet counts ( &lt; 200,000/mm 3) at the start of therapy are more likely to develop thrombocytopenia during treatment.
Fravær af indikation for flebotomi blev defineret som bekræftet HCT på &gt; 45%, dvs. mindst 3 procentpoint højere end HCT ved baseline eller en bekræftet HCT på &gt; 48% alt efter, hvilken der var lavest.
Phlebotomy eligibility was defined as a confirmed HCT of &gt; 45%, i.e. at least 3 percentage points higher than the HCT obtained at baseline or a confirmed HCT of &gt; 48%, depending on which was lower.
Ruxolitinib metaboliseres hovedsagelig af CYP3A4 ( &gt; 50%) med yderligere bidrag fra CYP2C9.
Ruxolitinib is mainly metabolised by CYP3A4 ( &gt; 50%), with additional contribution from CYP2C9.
De fleste patienter havde fået mindst to flebotomier i de sidste 24 uger inden screening.
Most patients ( &gt; 80%) had received at least two phlebotomies in the last 24 weeks prior to screening.
3 ( &gt; 5-20 x ULN)
c grade 3 ( &gt; 5x - 20 x ULN)
Ud af 301 patienter havde 111 (36,9%) et baselinetrombocytniveau på mellem 100.000/mm og 200.000/mm 3, og 190 patienter (63,1%) havde et baseline-trombocytniveau &gt; 200.000/mm
Of 301 patients, 111 (36.9%) had a baseline platelet count of between 100,000/mm and 200,000/mm and 190 (63.1%) had a baseline platelet count of
Der er begrænset data til at anbefale en startdosis til patienter med trombocyttal mellem 50.000/mm og &lt; 100.000/mm3.
There is limited information to recommend a starting dose for patients with platelet counts between 50,000/mm and &lt; 100,000/mm 3.
Signifikant flere patienter behandlet med Jakavi (23%) opnåede primært respons (p &lt; 0,0001) sammenlignet med BAT (0,9%).
Significantly more patients treated with Jakavi (23%) achieved a primary response (p &lt; 0.0001) compared to BAT (0.9%).
Patienter med trombocyttal på 100.000/mm til 200.000/mm 3, før de startede med ruxolitinib, havde en højere frekvens af trombocytopeni grad 3 eller 4 end patienter med trombocyttal på &gt; 200.000/mm
Patients with a platelet count of 100,000/mm to 200,000/mm before starting ruxolitinib had a higher frequency of grade 3 or 4 thrombocytopenia compared to patients with platelet count &gt; 200,000/mm
Neutropeni (absolut neutrofiltælling &lt; 500) var generelt reversibel og håndteredes ved at afbryde behandlingen med Jakavi midlertidigt (se pkt.
Neutropenia (absolute neutrophil count &lt; 500) was generally reversible and was managed by temporarily withholding Jakavi (see sections 4.2 and 4.8).
3 ( &lt; 8,0-6,5g/dl)
c grade 3 ( &lt; 8.0 - 6.5g/dl)
Ved uge 24 var den gennemsnitlige ændring i den almene helbredstilstand +12,3 for Jakavi og -3,4 for placebo (p &gt; 0,0001) målt ved EORTC QLQ-C30.
The mean change in the global health status at week 24, as measured by EORTC QLQ C30 was +12.3 for Jakavi and -3.4 for placebo (p &lt; 0.0001).
4 ( &lt; 6,5g/dl)
c grade 4 ( &lt; 6.5g/dl)
I COMFORT-I opnåede 45,9% af patienterne i Jakavi-gruppen en forbedring på ≥50% i forhold til baseline i den samlede symptomscore i uge 24 (målt ved MFSAF-dagbog v2.0) sammenlignet med 5,3% af patienterne i placebogruppen (p &lt; 0,0001 med anvendelse af chi
In COMFORT-I, 45.9% subjects in the Jakavi group achieved a ≥50% improvement from baseline in the week 24 total symptom score (measured using MFSAF diary v2.0), as compared to 5.3% in the placebo group (p &lt; 0.0001 using chi-square test).
Den anbefalede dosis af ruxolitinib til MF er 15 mg to gange dagligt til patienter med et trombocyttal mellem 100.000/mm og 200.000/mm og 20 mg to gange dagligt til patienter med trombocyttal
The recommended starting dose of ruxolitinib in MF is 15 mg twice daily for patients with a platelet count between 100,000/mm and 200,000/mm and 20 mg twice daily for patients with a platelet count of &gt; 200,000/mm 3.
3 ( &lt; 1.000-500/mm
c grade 3 ( &lt; 1,000 - 500/mm
4 ( &lt; 25.000/mm
c grade 4 ( &lt; 25,000/mm
En enkelt dosis på 20 mg eller to doser på 10 mg med 12 timers interval anbefales til MF-patienter med trombocyttal &gt; 200.000/mm Efterfølgende doser (administreret som enkeltdosis eller to doser på 10 mg med 12 timers interval) skal kun administreres på hæmodialysedagen efter hver dialysesession.
A single dose of 20 mg or two doses of 10 mg given 12 hours apart is recommended for MF patients with platelet count of &gt; 200,000/mm Subsequent doses (single administration or two doses of 10 mg given 12 hours apart) should be administered only on haemodialysis days following each dialysis session.
4 ( &lt; 500/mm
c grade 4 ( &lt; 500/mm
Andelen af patienter, som opnåede fuldstændig hæmatologisk remission, var 23,6% i Jakavi-armen sammenlignet med 8,0% i BAT-armen (p=0,0013).
The proportion of patients achieving a complete haematological remission was 23.6% on Jakavi compared to 8.0% on BAT (p=0.0013) and the proportion of patients achieving a durable primary response at week 48 was 20% on Jakavi and 0.9% on BAT (p &lt; 0.0001).
Alfred E. Tiefenbacher GmbH &amp; Co KG indgav en ansøgning for Galantamin Stada til den østrigske lægemiddelkontrolmyndighed med henblik på en decentral procedure.
Alfred E. Tiefenbacher GmbH &amp; Co KG submitted Galantamine Stada to the Austrian medicines regulatory agency for a decentralised procedure.
Infektioner og parasitÃ¦re sygdomme Hyppighed "Ikke almindelig": Cytomegalovirusinfektion eller reaktivering
Frequency ‘uncommon': Cytomegalovirus infection or reactivation
Hyppighed: Meget almindelig (≥1/10), almindelig (≥1/100 til &lt; 1/10), ikke almindelig (≥1/1.000 til &lt; 1/100), sjælden (≥1/10.000 til &lt; 1/1.000), meget sjælden ( &lt; 1/10.000) og ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
Frequency estimate: Very common (≥ 1/10), common (≥ 1/100 to &lt; 1/10), uncommon (≥ 1/1,000 to &lt; 1/100), rare (≥ 1/10,000 to &lt; 1/1,000), very rare ( &lt; 1/10,000) and not known (cannot be estimated from available data).
a Statistisk signifikans for non-inferiøritet med hele konfidensintervallet for HR pænt under 1,17645 for non- inferiøritet-margin (p &lt; 0,001).
a Statistically significant for non-inferiority, with the entire confidence interval for HR well below the 1.17645 non-inferiority margin (p &lt; 0.001).
Incidensen af bivirkninger blev evalueret for de patienter, som fik ≤6 serier af pemetrexedvedligeholdelsesbehandling (n=519), og sammenlignet med de patienter, som fik &gt; 6 serier pemetrexed (n=281).
The incidence of adverse reactions was evaluated for patients who received ≤ 6 cycles of pemetrexed maintenance (N=519), and compared to patients who received &gt; 6 cycles of pemetrexed (N=281).
Der blev observeret en signifikant øget forekomst af grad 3/4 neutropeni, som muligvis var relateret til studiemedicinen, ved længere eksponering for pemetrexed (≤6 serier: 3,3%; &gt; 6 serier: 6,4%; p=0,046).
A significant increase in the incidence of possibly study-drug-related Grade 3/4 neutropenia was observed with longer exposure to pemetrexed (≤ 6 cycles: 3.3 %, &gt; 6 cycles: 6.4 %: p=0.046).
ANC-nadir &lt; 500 /mm3 og nadir for trombocytter ≥ 50.000 /mm3
Nadir ANC &lt; 500/mm3 and nadir platelets ≥ 50,000/mm3
InformÃ©r din lÃ¦ge, hvis du for nylig er blevet vaccineret, da det muligvis kan forÃ¥rsage dÃ¥rlige virkninger med Pemetrexed Sandoz.
If you have been recently vaccinated, please tell your doctor, as this can possibly cause bad effects with Pemetrexed Sandoz.
Der er dog ikke foretaget specifikke studier med patienter med nedsat leverfunktion såsom bilirubin &gt; 1,5 gange den normale øvre grænseværdi og/eller aminotransferase &gt; 3,0 gange den normale øvre grænseværdi (uden forekomst af levermetastaser) eller &gt; 5,0 gange den normale øvre grænseværdi (med forekomst af levermetastaser).
However, patients with hepatic impairment, such as bilirubin &gt; 1.5 times the upper limit of normal and/or aminotransferase &gt; 3.0 times the upper limit of normal (hepatic metastases absent) or &gt; 5.0 times the upper limit of normal (hepatic metastases present), have not been specifically studied.
Hos patienter med en normal nyrefunktion (kreatinin-clearance ≥ 80 ml/min) kan høje doser af nonsteroide anti-inflammatoriske lægemidler (NSAID-præparater såsom ibuprofen &gt; 1600 mg/dag) og acetylsalicylsyre i høje doser (≥ 1,3 g daglig) nedsætte udskillelsen af pemetrexed, og dermed øge forekomsten af bivirkninger relateret til pemetrexed.
In patients with normal renal function (creatinine clearance ≥ 80 ml/min), high doses of nonsteroidal anti-inflammatory drugs (NSAIDs, such as ibuprofen &gt; 1600 mg/day) and acetylsalicylic acid at higher dose (≥ 1.3 g daily) may decrease pemetrexed elimination and, consequently, increase the occurrence of pemetrexed adverse events.
Patienterne behøvede ligeledes mindre erythropoietin/darbopoietin (10,4 % mod 18,1 %, p &lt; 0,001), G-CSF/GM-CSF (3,1 % mod 6,1 %; p=0,004) og midler med jern (4,3 5 mod 7,0 %; p=0,021).
Patients also required lower administration of erythropoietin/darbopoietin (10.4% versus 18.1%, p &lt; 0.001), G-CSF/GM-CSF (3.1% versus 6.1%, p = 0.004), and iron preparations (4.3% versus 7.0%, p = 0.021).
Patienter, der blev behandlet med pemetrexed og cisplatin, havde brug for færre transfusioner (16,4 % mod 28,9 %; p &lt; 0,001), transfusioner af røde blodlegemer (16,1 % mod 27,3 %; p &lt; 0,001) og blodpladetransfusioner (1,8 % mod 4,2 %; p=0,002).
Patients treated with pemetrexed and cisplatin required fewer transfusions (16.4% versus 28.9%, p &lt; 0.001), red blood cell transfusions (16.1% versus 27.3%, p &lt; 0.001) and platelet transfusions (1.8% versus 4.5%, p = 0.002).
Nedenstående tabel viser hyppigheden og sværhedsgraden af bivirkninger, der blev rapporteret hos &gt; 5 % af 168 patienter med mesoteliom, som var randomiseret til behandling med cisplatin og pemetrexed, og 163 patienter med mesoteliom, som var randomiseret til enkeltstofbehandling med cisplatin.
The table below provides the frequency and severity of undesirable effects that have been reported in &gt; 5 % of 168 patients with mesothelioma who were randomised to receive cisplatin and pemetrexed, and 163 patients with mesothelioma randomised to receive single-agent cisplatin.
Fishers eksakte p-niveau*
Fisher's exact p-value* &lt; 0.001
Nadir for trombocytter &lt; 50.000 /mm3 uanset ANC-nadir
Nadir platelets &lt; 50,000/mm3 regardless of nadir ANC
Nedenstående tabel viser hyppigheden og sværhedsgraden af bivirkninger, der blev vurderet som muligt relateret til studiesubstans, og som blev rapporteret hos &gt; 5 % af de 839 patienter med NSCLC, der blev randomiseret til at få cisplatin og pemetrexed, samt de 830 patienter med NSCLC, som blev randomiseret til at få cisplatin og gemcitabin.
The table below provides the frequency and severity of undesirable effects considered possibly related to study drug that have been reported in &gt; 5 % of 839 patients with NSCLC who were randomised to receive cisplatin and pemetrexed and 830 patients with NSCLC who were randomised to receive cisplatin and gemcitabine.
Nedenstående tabel viser hyppigheden og sværhedsgraden af bivirkninger, der blev rapporteret hos &gt; 5 % af 265 patienter, som var randomiseret til enkeltstofbehandling med pemetrexed og tilskud af folsyre og B12-vitamin, og 276 patienter, som var randomiseret til enkeltstofbehandling med docetaxel.
The table below provides the frequency and severity of undesirable effects that have been reported in &gt; 5 % of 265 patients randomly assigned to receive single-agent pemetrexed with folic acid and vitamin B12 supplementation, and 276 patients randomly assigned to receive single-agent docetaxel.
Patienter med let til moderat nyreinsufficiens (kreatinin-clearance på 45-79 ml/min) skal undgå at tage non-steroide anti-inflammatoriske lægemidler (NSAID-præparater) såsom ibuprofen og acetylsalicylsyre ( &gt; 1,3 g daglig) i mindst 2 dage før, på dagen for og i mindst 2 dage efter indgift af pemetrexed (se pkt.
Patients with mild to moderate renal insufficiency (creatinine clearance from 45 to 79 ml/min) should avoid taking non-steroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen, and acetylsalicylic acid ( &gt; 1.3 g daily) for 2 days before, on the day of, and 2 days following pemetrexed administration (see section 4.5).
Studiet mødte dets primære endepunkt og viste statistisk signifikant forbedring i PFS i pemetrexed- delen i forhold til placebodelen (n = 581, en uafhængig overvåget population, gennemsnit på henholdsvis 4 måneder og 2 måneder) (hazard ratio = 0,60, 95% CI = 0,49-0,73; p &lt; 0,00001).
The study met its primary endpoint and showed a statistically significant improvement in PFS in the pemetrexed arm over the placebo arm (N = 581, independently reviewed population; median of 4.0 months and 2.0 months, respectively) (hazard ratio = 0.60,95% CI = 0.49-0.73, p &lt; 0.00001).
De klinisk relevante CTC-toksiciteter, som blev rapporteret hos ≥ 1 % og &lt; 5 % af de patienter, der var randomiseret til pemetrexed, omfattede: infektion uden neutropeni, febril neutropeni, allergisk reaktion/overfølsomhed, forhøjet kreatinin, motorisk neuropati, sensorisk neuropati, erythema multiforme og mavesmerter.
Clinically relevant CTC toxicities that were reported in ≥ 1 % and ≤ 5 % of the patients that were randomly assigned to pemetrexed include: infection without neutropenia, febrile neutropenia, allergic reaction/hypersensitivity, increased creatinine, motor neuropathy, sensory neuropathy, erythema multiforme, and abdominal pain.
Pemetrexed anbefales derfor ikke til patienter med en kreatinin-clearance på &lt; 45 ml/min
Therefore, the use of pemetrexed in patients with creatinine clearance of &lt; 45ml/min is not recommended (see section 4.2).
De klinisk relevante CTC-toksiciteter, som blev rapporteret hos ≥ 1 % og &lt; 5 % af de patienter, der var randomiseret til cisplatin og pemetrexed, omfattede: nyresvigt, infektion, pyreksi, febril neutropeni, forhøjet ASAT, ALAT og GGT, nældefeber og brystsmerter.
Clinically relevant CTC toxicities that were reported in ≥ 1 % and ≤ 5 % of the patients that were randomly assigned to receive cisplatin and pemetrexed include: renal failure, infection, pyrexia, febrile neutropenia, increased AST, ALT, and GGT, urticaria and chest pain.
InformÃ©r din lÃ¦ge, hvis du har en hjertesygdom eller tidligere har haft en hjertesygdom.
If you have heart disease or a history of heart disease, please tell your doctor.
Bivirkningerne blev rapporteret hos &gt; 5 % af de 800 patienter, som var randomiseret til enkeltstofbehandling med pemetrexed, og de 402 patienter, som var randomiseret til placebo i studiet med pemetrexed vedligeholdelsesbehandling (JMEN:
The table below provides the frequency and severity of undesirable effects considered possibly related to study drug that have been reported in &gt; 5 % of 800 patients randomly assigned to receive single-agent pemetrexed and 402 patients randomly assigned to receive placebo in the single-agent pemetrexed maintenance (JMEN: N= 663) and continuation pemetrexed maintenance (PARAMOUNT: N=539) studies.
Nogle patienter kan lejlighedsvis have meget høje glukoseværdier, dvs. &gt; 20 mmol/l ( &gt; 360 mg/dl).
Patients occasionally may have very high glucose values, i.e. &gt; 20 mmol/L ( &gt; 360 mg/dL).