natgillin/translations-raw huggingface dataset:
• For patienter, der får fibrater som lipidsænkende behandling, bør lægen tage stilling til, om dette er det mest hensigtsmæssige medicinvalg.
• They should review the treatment of patients who are receiving fibrates to help control their lipid levels to ensure that the patient is receiving the most appropriate treatment.
Dato for første markedsføringstilladelse: 6. januar 2011 Dato for seneste fornyelse: 5. oktober 2015
Date of first authorisation: 6 January 2011 Date of latest renewal: 5 October 2015
− hvis dine blodcelletal er for lave.
; - if your blood cell counts are too low.
Denne tilstand kan blive dødelig.
This condition can be fatal.
CI = konfidensinterval.
CI = confidence interval.
Du skal informere din læge straks hvis du oplever nogen af følgende alvorlige bivirkninger.
You must tell your doctor immediately if you experience any of the following serious side effects.
Tabel 2 Resultater studie GOG-0179
Study results Study GOG-0179
Søg derefter vurdering hos en læge.
Then seek medical evaluation by a physician.
Relapserende SCLC
Relapsed SCLC
Da du får denne medicin af en læge eller sygeplejerske, er det usandsynligt, at du får for meget.
As this medicine is being given by your doctor or nurse, it is unlikely that you will be given too much.
Fortæl din læge eller sygeplejerske, hvis du er bekymret over den mængde medicin, du får.
Tell your doctor or nurse if you have any concerns about the amount of medicine that you receive.
Potactasol må ikke gives til gravide kvinder, medmindre det er tvingende nødvendigt.
Potactasol should not be used in pregnant women, unless clearly necessary.
Patienter, der er bekymrede for deres fertilitet, skal spørge lægen til råds om muligheder for fertilitetsog familieplanlægning, før behandlingen påbegyndes.
Patients who are concerned about their fertility should ask their doctor for counselling on fertility and family planning options prior to starting treatment.
Mediantid indtil progression (uger)
Median time to progression (weeks)
Der er ikke udført “in vivo” humane farmakokinetiske interaktionsstudier.
No in vivo human pharmacokinetic interaction studies have been performed.
Der skal udvises forsigtighed for at undgå, at lægemidlet ved et uheld kommer i kontakt med øjnene.
Precautions should be taken to avoid the medicinal product accidentally coming into contact with the eyes.
Rekonstitution og fortynding før administration
Reconstitution and dilution prior to administration
Bivirkningerne nævnt herunder er, opdelt efter systemorganklasse og absolut hyppighed (alle indberettede hændelser).
Adverse reactions are listed below, by system organ class and absolute frequency (all reported events).
(n = 8), unge (n = 3) og yngre voksne (n = 3) med leukæmi.
(n = 8), adolescents (n = 3) and young adults (n = 3) with leukaemia.
En læge eller en sygeplejerske vil give dig den tilberedte og fortyndede Potactasol opløsning som infusion (drop), sædvanligvis i armen over en periode på ca. 30 minutter.
A doctor or nurse will give you the reconstituted and diluted Potactasol solution as an infusion (drip), usually into your arm, over about 30 minutes.
Topotecan havde ligeledes et højt distributionsvolumen på omkring 132 l (SD 57), samt en relativ kort halveringstid på 2-3 timer.
Topotecan also had a high volume of distribution, about 132 l, (SD 57), and a relatively short half-life of 2-3 hours.
Antitumoraktivitet blev vist primært hos patienter med neuroblastoma.
Anti-tumour activity was demonstrated primarily in patients with neuroblastoma.
Som det ville være forventet har patienter med dårlig performancestatus (PS ≥ 1) en lavere responsrate og en øget forekomst af komplikationer såsom feber, infektion og sepsis (se pkt 4.8).
As would be expected, patients with poor performance status (PS > 1) have a lower response rate and an increased incidence of complications such as fever, infection and sepsis (see section 4.8).
Administration af topotecan til den pædiatriske population er undersøgt, men kun begrænsede data om virkning og sikkerhed er tilgængelige.
Topotecan was also evaluated in the paediatric population; however, only limited data on efficacy and safety are available.
Der er ikke foretaget undersøgelser af virkningen på evnen til at føre motorkøretøj eller betjene maskiner.
No studies of the effects on the ability to drive and use machines have been performed.
Hætteglas 4 år.
Vials 4 years.
- Unormalt højt niveau af bilirubin, et restprodukt som leveren producerer under nedbrydelsen af røde blodceller.
- Abnormal high level of bilirubin, a waste product produced by the liver during breakdown of red blood cells.
I et populationsstudie havde et antal faktorer, herunder alder, vægt og ascites ingen signifikant virkning på clearance af total topotecan (aktiv og inaktiv form).
In a population study, a number of factors including age, weight and ascites had no significant effect on clearance of total topotecan (active and inactive form).
Hvis du får for meget Potactasol
If you are given too much Potactasol
Ekstravasation3
extravasation3
Potactasol kan medføre træthed eller svaghed.
Potactasol can make you feel tired or weak.
Der sås ringe eller ingen akkumulering af topotecan efter gentagen daglig dosering og der var ingen tegn på ændring i farmakokinetikken efter multiple doser.
There is little or no accumulation of topotecan with repeated daily dosing and there is no evidence of a change in the pharmacokinetics after multiple doses.
Det kan være nødvendigt at justere din dosis af Potactasol.
Your dose of Potactasol may need to be adjusted.
Patienter bør monitoreres for pulmonale symptomer, der indikerer (ILD) (eks. hoste, feber, dyspnø og/eller hypoxia), og topetecan bør seponeres, hvis en ny diagnose af ILD bekræftes.
Patients should be monitored for pulmonary symptoms indicative of ILD (e.g. cough, fever, dyspnoea and/or hypoxia), and topotecan should be discontinued if a new diagnosis of ILD is confirmed.
Cytotoksisk, særlig instruktion (se indlægsseddel).
Cytotoxic, special handling instructions (see package leaflet).
Når topotecan gives sammen med andre kemoterapeutika, kan det være nødvendigt at reducere dosis af de enkelte lægemidler for at forbedre tolerabiliteten.
When combining topotecan with other chemotherapy agents, reduction of the doses of each medicinal product may be required to improve tolerability.
Arealet under kurven (AUC) øges omtrent proportionalt med dosisforøgelsen.
Area under the curve increased approximately in proportion to the increase in dose.
til < 1/10), ikke almindelig (≥ 1/1.000, til < 1/100), sjælden (≥ 1/10.000, til < 1/1.000), meget sjælden (< 1/10.000), og ikke kendte (kan ikke estimeres ud fra forhåndenværende data).
Frequencies are defined as: very common (≥ 1/10), common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000) and not known (cannot be estimated from the available data).
Prækliniske studier tyder på, at topotecans plasmaproteinbinding var lav (35 %), og fordelingen mellem blodceller og plasma var rimelig homogen.
Preclinical studies indicate plasma protein binding of topotecan is low (35 %) and distribution between blood cells and plasma was fairly homogeneous.
Selvom det ikke vides om topotecan udskilles i human brystmælk, skal amning stoppes ved behandlingsstart.
Although it is not known whether topotecan is excreted in human breast milk, breast-feeding should be discontinued at the start of therapy.
Erfaringen med behandling af børn og unge er begrænset, og Potactasol frarådes derfor.
The experience in children and adolescents is limited and treatment is therefore not recommended.
Det andet studie med et doseringsinterval på 2,0 til 5,2 mg/m2 til børn
The second study included a dose range of 2.0 to 5.2 mg/m2 in children
Gravide kvinder blandt personalet bør ikke arbejde med cytotoksisk præparation.
Pregnant staff should not handle the cytotoxic preparation.
In vitro hæmmede topotecan hverken de menneskelige P450-enzymer CYP1A2, CYP2A6, CYP2C8/9, CYP2C19, CYP2D6, CYP2E, CYP3A og CYP4A eller de menneskelige cytosoliske enzymer dihydropyrimidin eller xanthinoxidase.
In vitro, topotecan did not inhibit human P450 enzymes CYP1A2, CYP2A6, CYP2C8/9, CYP2C19, CYP2D6, CYP2E, CYP3A or CYP4A nor did it inhibit the human cytosolic enzymes dihydropyrimidine or xanthine oxidase.
Hvis du er i behandling for livmoderhalskræft, kan du få bivirkninger af den anden medicin (cisplatin), som du vil få sammen med Potactasol.
If you are being treated for cervical cancer, you may get side effects from the other medicine (cisplatin) that you will be given along with Potactasol.
Hyppigt rapporterede nonhæmatologiske bivirkninger var gastrointestinale, såsom kvalme (52 %), opkastning (32 %), diarre (18 %), obstiptation (9 %) og mucositis (14 %).
Frequently reported non-haematological effects were gastrointestinal such as nausea (52 %), vomiting (32 %), diarrhoea (18 %), constipation (9 %) and mucositis (14 %).
I kliniske studier blev topotecanbehandlingen stoppet, hvis dosis var blevet reduceret til 1,0 mg/m2/dag og yderligere reduktion af dosis var nødvendig, for at håndtere bivirkninger.
In clinical studies, topotecan was discontinued if the dose had been reduced to 1.0 mg/m2/day and a further dose reduction was required to manage adverse effects.
I en population af patienter med refraktær SCLC (dem som ikke responderer på førstebehandling) var responsraten for topotecan 4,0 %.
In a population of patients with refractory SCLC (those not responding to first-line therapy), the response rate to topotecan was 4.0 %.
Topotecan-O-glucuronid og N-desmethyl topotecan O glucuronid i urinen var mindre end 2,0 %.
The topotecan-O-glucuronide and N-desmethyl topotecan-O-glucuronide in the urine were less than 2.0 %.
• Alt udstyr brugt til administration eller rengøring, herunder handsker, bør anbringes i en højrisiko-affaldssæk til forbrænding ved høj temperatur.
− All items for administration or cleaning, including gloves, should be placed in high-risk, waste disposal bags for high-temperature incineration.
En N-desmethyl metabolit, som i et cellebaseret assay har vist sig at have samme eller mindre aktivitet end lægemiddelstoffet, er fundet i urin, plasma og fæces.
An N-desmethyl metabolite, which was shown to have similar or less activity than the parent in a cell-based assay, was found in urine, plasma, and faeces.
Hos patienter, der var refraktære eller som fik tilbagefald inden for 3 måneder efter cisplatinbehandling (n = 186), var responsraten 10 %.
In patients refractory to, or relapsing within 3 months after cisplatin therapy (n = 186), the response rate was 10 %.
Overordnet genvinding af topotecan-relateret materiale efter fem daglige doser af topotecan var 71 til 76 % af den administrerede intravenøse dosis.
Overall recovery of topotecan-related material following five daily doses of topotecan was 71 to 76 % of the administered IV dose.
Følgende tumortypervar inkluderet: Ewing's sarkom/primitiv neuroektoderm tumor, neuroblastoma, osteoblastoma og rhabdomyosarcoma.
Tumour types included were Ewing's sarcoma/primitive neuroectodermal tumour, neuroblastoma, osteoblastoma, and rhabdomyosarcoma.
- Hævelser, der er forårsaget af væskeophobninger (angioødemer) f.eks. rundt om øjne og læber,
- Swelling caused by fluid build-up (angioedema) e.g. around the eyes and lips as well as hands,
Ovariecancer og småcellet lungecancer
Ovarian cancer and small cell lung cancer
Forsigtighed bør dog udvises ved kørsel med motorkøretøj eller ved betjening af maskineri, hvis træthed og asteni vedvarer.
However, caution should be observed when driving or operating machines if fatigue and asthenia persist.
Topotecan er dog som andre cytostatika genotoksisk, og påvirkning af fertiliteten, herunder den mandlige fertilitet, kan ikke udelukkes.
However, as with other cytotoxic medicinal products topotecan is genotoxic and effects on fertility, including male fertility, cannot be excluded.
- Milde smerter og betændelse på injektionsstedet p.g.a. forkert injektion af lægemidlet i den omkringliggende hud (extravasation) f.eks. udsivning.
- Mild pain and inflammation at the site of injection due to accidental administration of the medicinal product into the surrounding tissue (extravasation) e.g. by leakage.
Hyppigheden af alvorlig (grad 3 eller 4) kvalme, opkastning, diarre og mucositis var henholdsvis 4, 3, 2 og 1 %.
The incidence of severe (Grade 3 or 4) nausea, vomiting, diarrhoea and mucositis was 4, 3, 2 and 1 % respectively.
POTACTASOL INSTRUKTION
Potactasol INSTRUCTIONS ON USE
Du må ikke amme under behandlingen med Potactasol.
You must not breast-feed while on treatment with Potactasol.
Andre bivirkninger med Potactasol inkluderer: Meget almindelige bivirkninger (kan ske hos flere end 1 ud af 10 personer):
Other side effects with Potactasol include: Very common side effects (may affect more than 1 in 10 people)
I sådanne tilfælde er behandling med Potactasol kombineret med medicin, der indeholder cisplatin.
In this case Potactasol treatment is combined with medicines containing cisplatin.
• Gravide medarbejdere må ikke arbejde med dette lægemiddel.
− Pregnant staff should be excluded from working with this medicinal product.
Det skal du vide, før du får Potactasol Du må ikke få Potactasol
What you need to know before you use Potactasol Do not use Potactasol
Læs pakningens indlægsseddel inden brug.
Read the package leaflet before use.
• Uforvarende berøring med hud eller øjne skal omgående behandles med rigelige mængder vand.
− Accidental contact with the skin or eyes should be treated immediately with copious amounts of water.
Potactasol bruges til at behandle: - ovariecancer eller - småcellet lungekræft, som er kommet igen efter kemoterapi - fremskreden livmoderhalskræft, hvor behandling med kirurgi eller stråleterapi ikke er mulig.
Potactasol is used to treat: - ovarian cancer or small cell lung cancer that has come back after chemotherapy - advanced cervical cancer if surgery or radiotherapy is not possible.
De normale procedurer for korrekt håndtering og bortskaffelse af anticancermedicin skal overholdes,
The normal procedures for proper handling and disposal of anticancer medicinal products should be adopted, namely:
ITT-population Cisplatin 50 mg/m2 på dag 1, hver 21. dag
ITT population Cisplatin 50 mg/m2 on day 1, every 21 days
Hvordan Potactasol tilberedes
How Potactasol is prepared
Samlet set, bidrog N-desmethyl metabolitten i gennemsnit mindre end 7 % (interval 4-9 %) til det topotecan-relaterede materiale i urin og fæces, som der kunne gøres rede for.
Overall, the N-desmethyl metabolite contributed a mean of less than 7 % (range 4-9 %) of the total topotecan-related material accounted for in the urine and faeces.
Den samlede hæmatologiske toksicitet er lavere hos patienter behandlet med topotecan i kombination med cisplatin sammenlignet med topotecan-monotrapi, men højere end med cisplatin alene.
The overall haematological toxicity is lower in patients treated with topotecan in combination with cisplatin compared to topotecan monotherapy, but higher than with cisplatin alone.
Potactasol indeholder natrium
Potactasol contains sodium
I studier til dosisbestemmelse omfattende 523 patienter med recidiverende ovariecancer og 631 patienter med recidiverende småcellet lungecancer var den dosisbegrænsende toksicitet af topotecanmonoterapi hæmatologisk.
In dose-finding studies involving 523 patients with relapsed ovarian cancer and 631 patients with relapsed small cell lung cancer, the dose limiting toxicity of topotecan monotherapy was found to be haematological.
- Generel følelse af slaphed og træthed, som kan være symptomer på fald i antallet af røde blodceller (anæmi).
- Feeling generally weak and tired, which can be symptoms of a decrease in the number of red blood cells (anaemia).
Topotecan er blevet associeret med rapporter om interstitiel lungesygdom (ILD), og nogle af disse tilfælde har været fatale (se pkt.
Topotecan has been associated with reports of interstitial lung disease (ILD), some of which have been fatal (see section 4.8).
oral topotecan plus BSC-gruppen var der en statisistiks signifikant forbedring i samlet overlevelse sammenlignet med gruppen med BSC alene (log-rank p = 0,0104).
In the oral topotecan plus BSC group there was a statistically significant improvement in overall survival compared with the BSC alone group (Log-rank p = 0.0104).
Anæmi: Moderat til alvorlig anæmi (Hb ≤ 8,0 g/dl) hos 37 % af patienterne (14 % af serierne).
Anaemia: Moderate to severe (Hb ≤ 8.0 g/dl) in 37 % of patients (14 % of courses).
Som for andre cytostatika kan topotecan forårsage fosterskader, hvorfor kvinder i den fertile alder bør tilrådes at undgå graviditet, hvis de er i behandling med topotecan.
As with other cytotoxic medicinal products, topotecan may cause foetal harm and therefore women of childbearing potential should be advised to avoid becoming pregnant during therapy with topotecan.
Hvis enten cisplatin eller carboplatin gives på dag 1 for topotecan doseringen, skal der gives en lavere dosis af begge stoffer, for at forbedre tolerancen, i forhold til den indivudielle dosis der kan gives af platin stofferne, hvis de gives på dag 5 for topotecan doseringen.
If either cisplatin or carboplatin is given on day 1 of the topotecan dosing, a lower dose of each agent must be given to improve tolerability compared to the dose of each agent which can be given if the platinum agent is given on day 5 of the topotecan dosing.
Potactasol kan nedsætte antallet af blodceller (blodplader).
Potactasol may cause a decrease in the number of blood clotting cells (platelets).
Du skal anvende effektive præventionsmetoder under behandlingen med Potactasol for at undgå at blive gravid eller blive far til et barn.
Effective contraception methods should be used to avoid becoming pregnant or fathering a child while on treatment with Potactasol.
Cisplatin produktinformation bør konsulteres for en komplet liste over bivirkninger associeret til brugen af cisplatin.
The prescribing information for cisplatin should be consulted for a full list of adverse events associated with cisplatin use.
I et populationsstudie med intravenøs administration havde samtidig administration af granisetron, ondansetron, morphin eller kortikosteroider, ingen signifikant virkning på farmakokinetikken af total topotecan (aktiv og inaktiv form).
In a population study using the intravenous route, the co-administration of granisetron, ondansetron, morphine or corticosteroids did not appear to have a significant effect on the pharmacokinetics of total topotecan (active and inactive form).
Den ikke-justerede hazard ratio for oral topotecan plus BSC-gruppen i forhold til gruppen med BSC alene var 0,64 (95 % CI; 0,45; 0,90).
The unadjusted hazard ratio for the oral topotecan plus BSC group relative to the BSC alone group was 0.64 (95 % CI: 0.45, 0.90).
Ved kombination med platin-baseret kemoterapi er der dog en særlig sekvens-afhængig interaktion, afhængig af om platin stoffet gives på dag 1 eller 5 i forhold til topotecan doseringen.
However, when combining with platinum agents, there is a distinct sequence-dependent interaction depending on whether the platinum agent is given on day 1 or 5 of the topotecan dosing.
Hvis det kommer i kontakt med øjnene, skylles der med rigelige mængder vand.
In the event of contact with the eyes, irrigate with large amounts of water.
Responsraten for topotecan i det kombinerede program for småcellet lungecancer [n = 480] for patienter med recidiverende sygdom efter førstebehandling var 20,2 %.
The response rate to topotecan in the combined small cell lung cancer programme (n = 480) for patients with relapsed disease sensitive to first-line therapy, was 20.2 %.
Potactasol indeholder det aktive stof topotekan, som hjælper til med at ødelægge kræftceller.
Potactasol contains the active substance topotecan which helps to kill tumour cells.
Brug ikke lægemidlet efter den udløbsdato, der står på hætteglasset og pakningen efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
Do not use this medicine after the expiry date which is stated on the vial and carton after EXP.
Kontakt lægen, før du får Potactasol hvis du har nyreproblemer.
Talk to your doctor before using Potactasol: - if you have any kidney problems.
- Allergi eller overfølsomhedsreaktioner (herunder udvikling af udslæt)
- Allergic (hypersensitivity) reactions (including rash).
Anti-tumor aktiviteten af topotecan involverer hæmning af topoisomerase-I, et enzym tæt involveret i DNA replikation, da den eliminerer det torsionale belastning, der opstår foran den bevægelige replikationsgaffel.
The anti-tumour activity of topotecan involves the inhibition of topoisomerase-I, an enzyme intimately involved in DNA replication as it relieves the torsional strain introduced ahead of the moving replication fork.
Den hæmatologiske toksicitet er dosisafhængig, og det samlede blodbillede, herunder trombocytter, bør fastlægges jævnligt (se pkt.
Haematological toxicity is dose-related and full blood count including platelets should be determined regularly (see section 4.2).
På baggrund af den toksiske grænseværdi for myelosuppression blev den maximalt tolererede dosis (MTD) fastsat til 2,0 mg/m2/dag med G-CSF og 1,4 mg/m2/dag uden GCSF i et farmakokinetisk studie hos børn med refraktære solide tumorer (se pkt.
Based on the dose-limiting toxicity of myelosuppression, the maximum tolerated dose (MTD) was established at 2.0 mg/m2/day with G-CSF and 1.4 mg/m2/day without G-CSF in a pharmacokinetic study in paediatric patients with refractory solid tumours (see section 5.2).
- Infektioner (meget almindelig, kan ske hos flere end 1 ud af 10 personer), med symptomer som: - feber - alvorlig forværrelse af din generelle tilstand - lokale symptomer så som halssmerter eller en brændende følelse, når du tisser - stærke mavesmerter, feber og muligvis diare (sjældent med blod) kan være tegn på tyktarmsbetændelse (neutropenisk colitis).
- Infections (very common; may affect more than 1 in 10 people), with signs such as: - fever - serious decline of your general condition - local symptoms, such as sore throat or burning sensation when urinating - severe stomach pain, fever and possibly diarrhoea (rarely with blood) can be signs of bowel inflammation (neutropenic colitis) Potactasol may reduce your ability to fight infections.
Reykjavikurvegi 76-78 220 Hafnarfjordur Island
Reykjavíkurvegi 76-78 220 Hafnarfjörður Iceland
Hvis det ikke anvendes omgående, er ansvaret for i-brug-tid og opbevaringsbetingelser forud for anvendelse brugers og vil normalt ikke være længere end 24 timer ved 2 til 8 °C, medmindre rekonstituering/fortynding er foretaget under kontrollerede og validerede aseptiske forhold.
If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2°C to 8°C, unless reconstitution/dilution has taken place in controlled and validated aseptic conditions.
Hvis serumkreatinin under kombinationsbehandling overstiger 1,5 mg/dl anbefales det at konsultere cisplatin produktinformation vedrørende dosisreduktion/fortsat behandling.
If, during topotecan/cisplatin combination therapy serum creatinine exceeds 1.5 mg/dl, it is recommended that the full prescribing information be consulted for any advice on cisplatin dose reduction/continuation.
Topotecan monoterapi og topotecan i kombination med cisplatin, er sædvanligvis associeret med klinisk relevant trombocytopeni.
Topotecan monotherapy and topotecan in combination with cisplatin are commonly associated with clinically relevant thrombocytopenia.