natgillin/translations-raw huggingface dataset:
Ved administration som en 3 timers infusion som førstevalg kemoterapi af ovariekræft, blev der rapporteret neurotoksicitet, arthralgi/ myalgi og overfølsomhed som oftere forekommende og kraftigere af patienter behandlet med paclitaxel efterfulgt af cisplatin end patienter behandlet med cyklofosfamid efterfult af cisplatin.
When administered as a 3 hour infusion for the first-line chemotherapy of ovarian cancer, neurotoxicity, arthralgia/ mayalgia, and hypersensitivity were reported as more frequent and severe by patients treated with paclitaxel followed by cisplatin than patients treated with cyclophosphamide followed by cisplatin.
Myelosuppression synes at forekomme mindre og med mindre kraft med paclitaxel som en 3 timers infusion efterfulgt af cisplatin sammenlignet med cyklofosfamid efterfulgt af cisplatin.
Myelosuppression appeared to be less frequent and severe with paclitaxel as a 3 hour infusion followed by cisplatin compared with cyclophosphamide followed by cisplatin.
Neurotoksicitet, hovedsagelig perifer neuropati, sunes af forekomme oftere og alvorligere med en 175 mg/ m2 3 timers infusion (85% neurotoksicitet, 15% alvorlig) end med en 135 mg/ m2 24 timers infusion (25% perifer neuropati, 3% alvorlig), når paclitaxel blev kombineret med cisplatin.
Neurotoxicity, mainly peripheral neuropathy, appeared to be more frequent and severe with a 175 mg/ m2 3 hour infusion (85% neurotoxicity, 15% severe) than with a 135 mg/ m2 24 hour infusion (25% peripheral neuropathy, 3% severe) when paclitaxel was combined with cisplatin.
Præ- eksisterende neuropatier som resultat af tidligere behandlinger er ikke en kontraindikation for behandling med paclitaxel.
Pre-existing neuropathies resulting from prior therapies are not a contraindication for paclitaxel therapy.
I otte offentliggjorte kliniske undersøgelser (8 fase III afprøvninger) omfattende 4735 patienter med fremskreden ovariekræft og i tolv offentliggjorte kliniske afprøvninger (én stor fase II og elve fase III afprøvninger) omfattende 4315 NSCLC patienter behandlet med paclitaxel og plitin- indeholdende regimer, blev der observeret lignende bivirkninger sammenlignet med enkeltmiddel paclitaxel behandling.
9 In eight published clinical trials (8 Phase III trials) including 4735 patients with advanced ovarian cancer and in twelve published clinical trials (one large Phase II and eleven Phase III trials) including 4315 NSCLC patients treated with paclitaxel and platinum-containing regimens, similar undesirable effects were observed compared to single-agent paclitaxel treatment.
Herudover forekom ileus, virkninger på kreatinin clearance, abnorme elektrolytter (f. eks. hyponatræmi, hypomagnesæmi) hyper glykæmi, hosten og pneumoni meget sjældent.
Additionally ileus, effects on creatinine clearance, abnormal electrolytes (e. g. hyponatremia, hypomagnesemia), hyperglycaemia, cough and pneumonia occurred very rarely.
Pneumonitis hos patienter, der fik samtidig strålebehandling og/ eller gemcitabene er meget sjældent rapporteret.
Pneumonitis in patients receiving concomitant radiotherapy and/ or gemcitabine has been reported very rarely.
AIDS- relateret Kaposis sarkom
AIDS related Kaposi’ s sarcoma
De følgende bivirkninger er i forbindelse med 107 AIDS- KS patienter, der blev behandlet med 100 mg/ m2 Paxene givet som en 3 timers infusion som andetvalg kemoterapi i en klinisk undersøgelse og blev betragtet som mulig eller sandsynlig relateret til Paxene.
The following undesirable effects relate to 107 AIDS-KS patients treated with 100 mg/ m2 Paxene administered as a 3 hour infusion as second-line chemotherapy in a clinical study, and were considered possibly or probably related to Paxene.
Med undtagelse af hæmatologiske og hepatiske hændelser (se nedenfor) var frekvensen og alvorligheden af bivirkninger hos AIDS- KS patienterne almindeligvis magen til dem, der blev set hos patienter med andre faste tumorer behandlet med paclitaxel monoterapi.
Except for haematological and hepatic events (see below), generally the frequency and severity of undesirable effects in AIDS-KS patients were similar to those noted in patients with other solid tumours treated with paclitaxel monotherapy.
Kraftig neutropeni (< 500 celler/ mm3) forekom hos henholdsvis 20% og 39% af patienterne under det første behandlingsforløb og hele behandlingsperioden.
Severe neutropenia (< 500 cells/ mm3) occurred in 20% and 39% of patients during the first course of treatment and the entire treatment period respectively.
Neutropeni var tilstede i > 7 dage hos 41% og i 30- 35 dage hos 8% af patienterne.
Neutropenia was present for > 7 days in 41% and for 30-35 days in 8% of patients.
Incidensen af grad 4 neutropeni varende 7 dage eller mere var 22%.
The incidence of Grade 4 neutropenia lasting 7 days or more was 22%.
Neutropenifeber relateret til Paxene blev rapporteret hos 14% af patienterne.
Neutropenic fever related to Paxene was reported in 14% of patients.
Der var tre septiske episoder (2, 8%) under indgivelse af Paxene relateret til lægemidlet, der viste sig at være fatale.
There were three septic episodes (2.8%) during Paxene administration related to the medicinal product that proved fatal.
Trombocytopeni blev set hos 50% af patienterne og var alvorlig (< 50. 000 celler/ mm3) hos 9%.
Thrombocytopenia was observed in 50% of patients, and was severe (< 50,000 cells/ mm3) in 9%.
Blødningsepisoder relateret til Paxene blev rapporteret hos < 3% af patienterne, og blødning var lokal.
Bleeding episodes related to Paxene were reported in < 3% of patients and bleeding was localised.
Anæmi (Hb < 11 g/ dl) blev set hos 61% af
Anaemia (Hb < 11 g/ dL) was observed in 61% of patients and was severe (Hb < 8 g/ dL) in 10%.
Transfusion af røde blodlegemer var påkrævet hos 21% af patienterne.
Red cell transfusions were required in 21% of patients.
Blandt patienterne (> 50% påproteasehæmmere) med normal leverfunktion fra starten, havde 28%, 43% og 44% forhøjelser af henholdsvis bilirubin, alkalisk fosfatase og AST (SGOT).
Among patients (> 50% on protease inhibitors) with normal baseline liver function, 28%, 43% and 44% had elevations in bilirubin, alkaline phosphatase and AST (SGOT), respectively.
For hver af disse parametre var øgningerne alvorlige i 1% af tilfældene.
For each of these parameters, the increases were severe in 1% of cases.
Der findes ikke en kendt antidot mod en Paxene- overdosis.
No known antidote exists for Paxene overdose.
Antineoplastiske stoffer (taxaner), ATC- kode:
Antineoplastic agents (taxanes), ATC code:
L01C D01
L01C D01.
Metastatisk brystkræft:
Metastatic breast cancer:
Effekt og sikkerhed af Paxene (175 mg/ m² over 3 timer i 3- ugers intervaller) ved refraktorisk metastatisk brystkræft blev undersøgt hos 172 kvinder i en åben fase III- multicenterundersøgelse.
10 The efficacy and safety of Paxene (175 mg/ m² over 3 hours at 3-week intervals) in refractory metastatic breast cancer were investigated in 172 women in a multicentre, open-label Phase III trial.
Den kliniske responsfrekvens var 18, 5%, mediantiden for progression var 2, 8 måneder (CI:
The clinical response rate was 18.5%, median time to progression was 2.8 months (CI:
2, 1 - 3, 3 måneder), og medianoverlevelsestiden var 9, 9 måneder (CI:
2.1 - 3.3 months) and the median survival time was 9.9 months (CI:
7, 8 - 13, 1 måneder).
7.8 - 13.1 months).
De resultater, der blev opnået med Paxene, ligger meget tæt på resultaterne fra offentliggjorte fase III - undersøgelser for paclitaxel.
The results obtained with Paxene are closely similar to those of published paclitaxel Phase III trials.
Fremskreden ovariekræft (førstevalgs behandling):
Advanced ovarian cancer (first-line treatment):
Cyklofosfamid 750 mg/ m2/ cisplatin 75 mg/ m2).
The efficacy and safety of paclitaxel were evaluated in two major, randomised, controlled trials (vs. cyclophosphamide 750 mg/ m2/ cisplatin 75 mg/ m2).
I den første afprøvning fik over 650 patienter med stadium IIb- c, II eller IV primær ovariekræft et maksimum på 9 behandlingsforløb med paclitaxel (175 mg/ m2 over 3 timer) efterfulgt af cisplatin (75 mg/ m2) eller kontrol.
In the first trial, over 650 patients with stage IIb-c, III or IV primary ovarian cancer received a maximum of 9 treatment courses of paclitaxel (175 mg/ m2 over 3 hours) followed by cisplatin (75 mg/ m2) or control.
Den anden store afprøvning evaluerede et maksimum på 6 forløb med enten paclitaxel (135 mg/ m2 over 24 timer) efterfulgt af cisplatin (75 mg/ m2) eller kontrol hos over 400 patienter med stadium III/ IV primær ovariekræft med en > 1 cm residual sygdom efter stadium laparotomi eller med fjerntliggende metastaser.
The second major trial evaluated a maximum of 6 courses of either paclitaxel (135 mg/ m² over 24 hours) followed by cisplatin (75 mg/ m²) or control in over 400 patients with stage III/ IV primary ovarian cancer, with a > 1 cm residual disease after staging laparotomy, or with distant metastases.
Selvom de to doseringer af paclitaxel ikke blev sammenlignet direkte med hinanden, havde patienterne i begge afprøvninger behandlet med paclitaxel i kombination med cisplatin en signifikant længere tid til progression (undersøgelse 1: median 15, 3 måneder vs 11, 5 måneder, p < 0. 001; undersøgelse 2 median 17 måneder vs 13 måneder, p < 0. 001) og længere overlevelse (undersøgelse 1: median 36 måneder vs 26 måneder, p=0. 0016; undersøgelse 2: median 36 måneder vs 24 måneder, p < 0. 001) og i undersøgelse 1 en signifikant højere responsrate (undersøgelse 1:
Although the two different paclitaxel posologies were not compared with each other directly, in both trials patients treated with paclitaxel in combination with cisplatin had a significantly longer time to progression (Study 1: median 15.3 months vs 11.5 months, p < 0.001; Study 2: median 17 months vs 13 months, p < 0.001), and longer survival time (Study 1: median 36 months vs 26 months, p= 0.0016; Study 2: median 36 months vs 24 months, p < 0.001), and in Study 1 a significantly higher response rate (Study 1:
59% vs 45%, p=0. 014; undersøgelse 2:
59% vs 45%, p= 0.014; Study 2:
60% vs 50%, NS) ved sammenligning med standardbehandling.
60% vs 50%, NS), when compared with standard therapy.
Øget neurotoksicitet, arthralgi/ myalgi, men nedsat myelosuppression blev set hos patienter med fremskreden ovariekræft, der fik givet 3 timers infusion af paclitaxel/ cisplatin sammenlignet med patienter, der fil cyklofosfamid/ cisplatin.
Increased neurotoxicity, arthralgia/ myalgia but reduced myelosuppression were observed in advanced ovarian cancer patients administered 3 hour infusion paclitaxel/ cisplatin as compared to patients who received cyclophosphamide/ cisplatin.
12 Metastatisk ovariekræft:
Metastatic ovarian cancer (second-line treatment):
Effekt og sikkerhed af Paxene (175 mg/ m² over 3 timer i 3- ugers intervaller) ved avanceret metastatisk ovariekræft blev undersøgt hos 120 kvinder i en åben udvidet fase II- multicenterundersøgelse.
The efficacy and safety of Paxene (175 mg/ m² over 3 hours repeated at 3-week intervals) in advanced metastatic ovarian cancer were investigated in 120 women in a multicentre, open-label extended Phase II trial.
Den kliniske responsfrekvens var 21, 7% (CI:
The clinical response rate was 21.7% (CI:
14, 7 - 31, 1%), mediantiden for progression var 4, 1 måneder (CI:
14.7 - 31.1%), median time to progression was 4.1 months (CI:
3, 3 - 4, 9 måneder), og medianoverlevelsestiden var 13, 4 måneder (CI:
3.3 - 4.9 months) and the median survival time was 13.4 months (CI:
11, 5 - 15, 0 måneder).
11.5 - 15.0 months).
De resultater, der blev opnået med Paxene, ligger meget tæt på resultaterne fra offentliggjorte paclitaxel fase III- undersøgelser.
The results obtained with Paxene are closely similar to those of published paclitaxel Phase III trials.
Fremskreden ikke- småcellet lungekræft:
Advanced non-small cell lung carcinoma:
Effekt af kombination af paclitaxel/ cisplatin er blevet påvist i to randomiserede, kontrollerede afprøvninger hos patienter med lokal fremskreden eller metastatisk NSCLC.
Efficacy of paclitaxel/ cisplatin combination has been demonstrated in two randomised, controlled trials in patients with locally advanced or metastatic NSCLC.
I den første undersøgelse blev 332 patienter med lokal fremskreden eller metastatisk NSCLC randomiseret til at få cisplatin (80 mg/ m2) i kombination med teniposid (100 mg/ m2; n = 166) eller cisplatin (80 mg/ m2) og paclitaxel (175 mg/ m²; n = 166).
There was no advantage in survival (9.5 vs.
Der var ingen fordel i overlevelse (9, 5 vs 9, 9 måneder) eller progressionfri overlevelse (5, 1 vs 5, 0 måneder) med cisplatin/ paclitaxel vs cisplatin/ tenoposid.
However, the higher response rates (37% vs.
De højere responsrater (37% vs 26%), mindre totale bivirkninger og forbedret korttids livskvalitet med cisplatin/ paclitaxel vs cisplatin/ tenoposid blev imidlertid betragtet som vigtige resulater i en palliativ population.
26%), lesser overall side effects and improved short term QoL with cisplatin/ paclitaxel vs cisplatin/ tenoposide were considered important results in a palliative population.
Grad 2 eller 3 perifer neurotoksicitet blev set mere almindeligt med cisplatin/ paclitaxel (29% vs 6%).
6%).
I den anden undersøgelse blev 599 patienter med stadium IIIB eller IV sygdom randomiseret til at få cisplatin (75 mg/ m2) og etoposid (100 mg/ m2, n = 200) eller cisplatin (75mg/ m2) og lavdosis paclitaxel (135 mg/ m2; n= 198) eller cisplatin (75 mg/ m2) og højdosis paclitaxel (250 mg/ m2) med G- CSF (n = 201).
In the second study, 599 patients with stage IIIB or IV disease were randomised to receive cisplatin (75 mg/ m2) and etoposide (100 mg/ m2; n= 200), or cisplatin (75 mg/ m2) and low-dose paclitaxel (135 mg/ m2; n= 198), or cisplatin (75 mg/ m2) and high-dose paclitaxel (250 mg/ m2) with G-CSF (n= 201).
Median overlevelse for hver paclitaxel- indeholdende arm var ikke dignifikant forskellig sammenlignet med etoposid( cisplatin) p=0. 097 og 0. 090 for henholdsvis højdosis paclitaxel og lavdosis paclitaxel).
Median survival for each paclitaxel-containing arm was not significantly different compared to etoposide/ cisplatin (p= 0.097 and 0.090 for high-dose paclitaxel and low-dose paclitaxel, respectively).
Med hensyn til progressionsfri overlevelse blev der set yderst statistisk signifikante resultater for højdosis paclitaxel- armen sammenlignet med etoposid/ cisplatin (p=0. 007).
With respect to progression free survival, highly statistically significant results were noted for the high-dose paclitaxel arm compared to etoposide/ cisplatin (p= 0.007).
Responsrater var stærkt i favør af de paclitaxel- indeholdende arme [13%, 30% og 26% for henholdsvis etoposid/ cisplatin, højdosis paclitaxel (p < 0. 001 vs etoposid/ cisplatin) og lavdosis paclitaxelregimer (p=0. 003 vs etoposid/ cisplatin)].
Response rates strongly favoured the paclitaxel-containing arms [13%, 30% and 26% for the etoposide/ cisplatin, high-dose paclitaxel (p < 0.001 vs etoposide/ cisplatin) and low-dose paclitaxel regimens (p= 0.003 vs
Grad 3 neurotoksicitet var imidlertid signifikant mere almindelig i højdosis paclitaxel armen vs etoposid/ cisplatin (40% vs 21%).
21%).
Effekt og sikker ved Paxene blev undersøgt i en enkelt ikke- sammenlignende undersøgelse hos 107 patienter med avanceret KS, som tidligere var blevet behandlet med systemisk kemoterapi.
The efficacy and safety of Paxene were investigated in a single, non-comparative study in 107 patients with advanced KS, previously treated with systemic chemotherapy.
I undersøgelsen fik hovedparten af patienterne administreret granulocytkoloni stimulerende faktor (G- CSF).
In the study, the majority of patients were administered granulocyte colony stimulating factor (G-CSF).
Patienterne fik en 3 timers infusion af Paxene 100 mg/ m2, som blev indgivet hver 14. dag.
Patients were given a 3 hour infusion of Paxene 100 mg/ m² administered every 14 days.
Den samlede respons (fuldstændig eller delvis respons) efter 15 behandlingsforløb var 57% (CI 44 - 70%) af liposomal anthracyklin- resistente patienter.
The overall success rate (complete or partial response) after 15 cycles of treatment was 57% (CI 44 – 70%) in liposomal anthracycline-resistant patients.
Hos liposomal anthracykliske- resistente patienter var responsraten sammenlignelig med patienter, der aldrig havde fået en proteasehæmmer (55, 6%) og de, der havde fået én mindst 2 måneder inden behandlingen med Paxene (60, 9%).
In liposomal anthracycline-resistant patients, the response rates were comparable for patients who had never received a protease inhibitor (55.6%) and those who received one at least 2 months prior to treatment with Paxene (60.9%).
Mediantiden for progression i kernepopulationen var 468 dage (95% CI 257 – NE).
The median time to progression in the core population was 468 days (95% CI 257-NE).
Median overlevelse for Paxene kunne ikke beregnes, men den nedre 95% grænse var 617 dage hos kernepatienter.
Median survival for Paxene could not be computed, but the lower 95% bound was 617 days in core patients.
Fordelingen af paclitaxel er ikke- lineær (koncentrationafhængigt), da den systemiske eksponering øges mere end forventet efter en stigning i doseringen.
The disposition of paclitaxel is non-linear (concentration dependent) as the systemic exposure increases more than expected following an increase in dosage.
På baggrund af in vitro- undersøgelser er niveauet af plasmaproteinbinding blevet rapporteret til at være i intervallet 88 - 98%.
Based on in vitro studies, the degree of plasma protein binding has been reported to range from 88 to 98%.
Farmakokinetiske parametre for paclitaxel ved 175 mg/ m2 indgivet over 3 timer hos 13 patienter med brystkræft var som følger: højeste koncentrationer (Cmax) var 3. 890 ng/ ml, arealet under plasmakoncentrationen vs. tidskurven (AUC) var på 14. 090 ng· t/ ml og clearance (CL) var på 13, 3 l/ t/ m2.
Pharmacokinetic parameters of paclitaxel at 175 mg/ m2 given over 3 hours in 13 patients with breast cancer were as follows: maximum concentration (Cmax) was 3,890 ng/ ml, area under the plasma concentration vs. time curve (AUClast) was 14,090 ng·h/ ml and clearance (CL) was 13.3 l/ h/ m2.
Metastatisk brystkræft / ovariekræft:
Metastatic breast or ovarian cancer:
Farmakokinetiske parametre for paclitaxel ved 175 mg/ m2 indgivet over 3 timer hos 5 patienter med brystkræft og hos 3 patienter med ovariekræft var som følger: højeste koncentrationer (Cmax) var 4. 213 ng/ ml, arealet under plasmakoncentrationen vs. tidskurven (AUC) var på 12. 603 ng· t/ ml og clearance (CL) var på 20, 4 l/ t/ m2.
Pharmacokinetic parameters of paclitaxel at 175 mg/ m2 given over 3 hours in 5 patients with breast cancer and 3 patients with ovarian cancer were as follows: maximum concentration (Cmax) was 4,213 ng/ ml, area under the plasma concentration vs. time curve (AUClast) was 12,603 ng·h/ ml and clearance (CL) was 20.4 l/ h/ m2.
Udskillelse gennem nyrerne spiller en mindre rolle i den samlede udskillelse af paclitaxel, hvor under 10% af dosen udskilles som uforandret lægemiddel i urinen.
Renal excretion plays a minor role in the elimination of paclitaxel, less than 10% of the dose has been reported to be excreted in the urine as unchanged drug.
Den største udskillelsesvej er metabolisme efterfulgt af udskillelse via galden; hos seks patienter blev 39% til 87% af en intravenøs dosis (175 mg/ m²) udskilt i fæces, og i gennemsnit blev kun 10% af dosen udskilt som uforandret paclitaxel.
The major elimination pathway is metabolism followed by biliary excretion; in six patients 39% to 87% of an intravenous dose (175 mg/ m2) was excreted in faeces and, on average, only 10% of the dose was excreted as unchanged paclitaxel.
Adskillige metabolitter er blevet sporet, men kun tre af dem er blevet identificeret:
Several metabolites have been detected, but only three of them have been identified:
6 alpha - hydroxypaclitaxel, 3 ’ - para- hydroxypaclitaxel og 6 alpha, 3 ’ para- dihydroxypaclitaxel.
6 alpha-hydroxypaclitaxel, 3’ -para-hydroxypaclitaxel and 6 alpha, 3’ -para-dihydroxypaclitaxel.
6 alpha- hydroxypaclitaxel var den overvejende udskilte komponent i fæces.
6 alpha-hydroxypaclitaxel is the major component excreted in faeces.
In vitro- undersøgelser har påvist, at CYP2C8 og 3A4 er involveret i dannelsen af henholdsvis 6 alpha- hydroxypaclitaxel og 3 ’ - para- hydroxypaclitaxel.
In vitro studies have shown that CYP2C8 and 3A4 are involved in the formation of 6 alpha-hydroxypaclitaxel and 3’ -para-dihydroxypaclitaxel, respectively.
Efter en intravenøs dosis på 100 mg/ m2 givet som en 3 timers infusion til 19 patienter med AIDS- relateret Kaposis sarkom varierede de højeste koncentrationer fra 761 til 2. 860 ng/ ml (gennemsnit 1. 530) og gennemsnitsværdien for arealet under plasmakoncentrationen vs. tidskurven (AUC) var på 5. 619 ng· t/ ml (variation 2. 609 - 9. 428).
12 Following an intravenous dose of 100 mg/ m2 given as a 3 hour infusion to 19 patients with AIDS- related Kaposi’ s sarcoma, the maximum concentrations ranged from 761 to 2,860 ng/ ml (mean 1,530) and average area under the plasma concentration vs. time curve (AUC) was 5,619 ng·h/ ml (range 2,609 - 9,428).
Clearance var på 20, 6 l/ t/ m2 (variation 11 - 38), og fordelingsvolumen var på 291 l/ m2 (variation 121 - 638).
Clearance was 20.6 l/ h/ m2 (range 11 - 38) and the volume of distribution was 291 l/ m2 (range 121 - 638).
Den terminale udskillelseshalveringstid var gennemsnitligt på 23, 7 timer (variation 12 - 33).
The terminal elimination half-life averaged 23.7 hours (range 12 - 33).
Carcinogenese, mutagenese, nedsat frugtbarhed:
Carcinogenesis, Mutagenesis, Impairment of Fertility:
Paclitaxel har vist sig at være genotoksisk in vivo (micronucleustest på mus); men det inducerede ikke mutagenicitet i Ames- testen eller Chinese hamster ovary/ hydoxantine- guanine phosphoribosyl transferase (CHO/ HGPRT) genmutations- testen.
Paclitaxel has been shown to be genotoxic in vivo (micronucleus test in mice), but it did not induce mutagenicity in the Ames test or the Chinese hamster ovary/ hypoxanthine-guanine phosphoribosyl transferase (CHO/ HGPRT) gene mutation assay.
Paclitaxel i små doser på 0, 6 mg/ kg/ dag medførte lav fertilitet og toksicitet på rottefostre.
Paclitaxel at low doses of 0.6 mg/ kg/ day was associated with low fertility and foetal toxicity in rats.
Polyoxyethyleret ricinusolie, citronsyre (vandfri) og ethanol (omtrent 392 mg/ ml).
Polyethoxylated castor oil, Citric acid (anhydrous), Ethanol (approximately 392 mg/ ml).
Ufortyndet koncentrat bør ikke komme i kontakt med PVC- udstyr eller udstyr til forberedelse af opløsninger til infusion, der indeholder blødgjort PVC.
Contact of the undiluted concentrate with plasticised PVC equipment or devices used to prepare solutions for infusion is not recommended.
For at udsætte patienten mindst muligt for blødgøringsmidlet DEHP [di - (2- ethylhexyl) phthalate], som kan lække fra PVC- infusionsposer eller - sæt, bør fortyndede Paxene- opløsninger opbevares i flasker (glas, polypropylene) eller plastikposer (polypropylene, polyolefin) og gives gennem polyethylen- forede administrationssæt.
In order to minimise patient exposure to the plasticiser DEHP [di-(2-ethylhexyl)phthalate], which may be leached from PVC infusion bags or sets, diluted Paxene solutions should be stored in bottles (glass, polypropylene) or plastic bags (polypropylene, polyolefin) and administered through polyethylene-lined administration sets.
2 år i en uåbnet hætteglas.
2 years in the unopened vial.
Kemisk, fysisk og mikrobiel stabilitet af uanvendt, ikke opløst lægemiddel der forbliver i hætteglasset er påvist i op til 28 dage ved opbevaring under 25°C.
Chemical, physical and microbial stability of unused, undiluted product remaining in the vial has been demonstrated for up to 28 days when stored below 25 °C.
Efter fortynding har kemisk og fysisk stabilitet i polypropylene infusionsposer i brug vist sig i mindst 24 timer ved opbevaring under 25°C.
Following dilution, chemical and physical in-use stability in polypropylene infusion bags has been demonstrated for 24 hours when stored below 25 ºC.