natgillin/translations-raw huggingface dataset:
som monoterapi: - hos voksne patienter (specielt overvægtige patienter), der er utilstrækkeligt reguleret via diæt og motion, og for hvem metformin ikke er velegnet på grund af kontraindikationer eller intolerans som oral kombinationsbehandling, sammen med - metformin hos voksne patienter (specielt overvægtige patienter) med utilstrækkelig glykæmisk kontrol på metformin-monoterapi på trods af maksimalt tolereret metformindosis - sulfonylurinstof hos voksne patienter med utilstrækkelig glykæmisk kontrol på monoterapi med sulfonylurinstof på trods af maksimalt tolereret sulfonylurinstofdosis; dog kun hos patienter, der udviser intolerans over for metformin, eller for hvem metformin er kontraindiceret som trippel oral kombinationsbehandling, sammen med - metformin og sulfonylurinstof hos voksne patienter (specielt overvægtige patienter) med utilstrækkelig glykæmisk kontrol på trods af oral kombinationsbehandling med to præparater.
as monotherapy - in adult patients (particularly overweight patients) inadequately controlled by diet and exercise for whom metformin is in appropriate because of contraindications or intolerance as dual oral therapy in combination with - metformin, in adult patients (particularly overweight patients) with insufficient glycaemic control despite maximal tolerated dose of monotherapy with metformin
ANVENDELSESMÅDE OG INDGIVELSESVEJ(E)
METHOD AND ROUTE (S) OF ADMINISTRATION
Hvis De har taget for meget Pioglitazone Accord Kontakt lægen, skadestuen eller apoteket, hvis De ved en fejltagelse har taget for mange tabletter, eller hvis en anden eller et barn tager Deres medicin.
If you take more Pioglitazone Accord than you should If you accidentally take too many tablets, or if someone else or a child takes your medicine, talk to a doctor or pharmacist immediately.
Øjne synsforstyrrelser2 almindelig almindelig ikke almindelig makulaødem ikke kendt ikke kendt ikke kendt ikke kendt ikke kendt
common common uncommon macular oedema not known not known not known not known not known
Der er rapporteret om hjerteinsufficiens under anvendelse af pioglitazon post-marketing og hyppigere, når pioglitazon bruges i kombinationsbehandling med insulin og hos patienter med tidligere hjerteinsufficiens.
Heart failure has been reported with marketing use of pioglitazone, and more frequently when pioglitazone was used in combination with insulin or in patients with a history of cardiac failure.
Pioglitazone Accord 15 mg tabletter Pioglitazone Accord 30 mg tabletter Pioglitazone Accord 45 mg tabletter
Pioglitazone Accord 15 mg tablets Pioglitazone Accord 30 mg tablets Pioglitazone Accord 45 mg tablets
Det skal De vide, før De begynder at tage Pioglitazone Accord
What you need to know before you take Pioglitazone Accord
Hvis De oplever bivirkninger, bør de tale med Deres læge.
If you get any side effects, talk to your doctor, pharmacist.
Carmellosecalcium Hydroxypropylcellulose Lactosemonohydrat Magnesiumstearat
Carmellose calcium Hydroxypropyl cellulose Lactose monohydrate Magnesium stearate
Nogle patienter, som har haft type 2-diabetes i mange år og samtidig har hjertesygdom, eller som har haft et slagtilfælde, har udviklet hjertesvigt, når de blev behandlet med Pioglitazone Accord og insulin samtidig.
Some patients with long-standing type 2 diabetes mellitus and heart disease or previous stroke who were treated with Pioglitazone Accord and insulin experienced the development of heart failure.
ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER
STATEMENT OF ACTIVE SUBSTANCE (S)
- let nedsat antal røde blodlegemer (blodmangel) - luftafgang fra tarmen ikke almindelige (kan påvirke op til 1 ud af 100 behandlede) - sukker i urinen, protein i urinen - forhøjede enzymtal - svimmelhed, hvor det føles, som om verden drejer rundt (vertigo) - svedudbrud - træthed - øget appetit
common (may affect up to 1 in 10 people) - headache - dizziness - joint pain - impotence - back pain - shortness of breath - small reduction in red blood cell count - flatulence uncommon (may affect up to 1 in 100 people) - sugar in urine, proteins in urine - increase in enzymes - spinning sensation (vertigo) - sweating - tiredness
Kombinationsbehandling med metformin med sulfonylurea med metformin og sulfonylurea med insulin
Combination with with sulpho with with insulin therapy metformin nylurea metformin and sulphonylurea
Der er rapporter om, at samtidig administration af pioglitazon og rifampicin (en inducer af CYP2C8) har resulteret i en 54% nedsættelse af AUC for pioglitazon.
Co-administration of pioglitazone with rifampicin (an inducer of cytochrome P450 2C8) is reported to result in a 54% decrease in AUC of pioglitazone.
Hjertesvigt har været almindeligt forekommende (kan påvirke op til 1 ud af 10 behandlede) hos patienter, der tager Pioglitazone Accord i kombination med insulin.
Heart failure has been experienced commonly (may affect up to 1 in 10 people) in patients taking Pioglitazone Accord in combination with insulin.
almindelig almindelig almindelig almindelig almindelig forhøjet kreatinkinase almindelig forhøjet laktatdehydrogenase ikke almindelig aminotransferase7 ikke kendt ikke kendt ikke kendt ikke kendt ikke kendt
common common common common common blood creatine phosphokinase increased common increased lactic dehydrogenase uncommon alanine aminotransferase increased 7
Når De har taget Pioglitazone Accord i 3-6 måneder, vil Deres læge undersøge, om medicinen virker.
Your doctor will check whether Pioglitazone Accord is working 3 to 6 months after you start taking it.
Lokale væskeansamlinger (ødemer) har ligeledes været meget almindeligt forekommende (kan påvirke flere end 1 ud af 10 behandlede) hos patienter, der tager Pioglitazone Accord i kombination med insulin.
Localised swelling (oedema) has also been experienced very commonly (may affect more than 1 in 10 people) in patients taking Pioglitazone Accord in combination with insulin.
Blærekræft forekommer med hyppigheden "ikke almindelig" (kan påvirke op til 1 ud af 100 behandlede) hos patienter, der tager Pioglitazone Accord.
Bladder cancer has been experienced uncommonly (may affect up to 1 in 100 people) in patients taking Pioglitazone Accord.
Søg hurtigst muligt læge, hvis De oplever nogle af disse bivirkninger, især hvis De er over 65°år.
If you experience any of these, especially if you are over the age of 65, seek medical advice straight away.
Tal med lægen, hvis De har indtryk af, at effekten af Pioglitazone Accord er for svag.
If you have the impression that the effect of Pioglitazone Accord is too weak, talk to your doctor.
Øvrige indholdsstoffer: lactosemonohydrat, carmellosecalcium, hydroxypropylcellulose (E465) og magnesiumstearat (E572).
• The other ingredients are lactose monohydrate, carmellose calcium, hydroxypropyl cellulose (E
Sage House, 319 Pinner Road, North Harrow, HA1 4HF, Middlesex Storbritannien
319 Pinner Road, North Harrow,
hjerteinsufficiens eller hjerteinsufficiens i anamnesen (NYHA-klasse I til IV) nedsat leverfunktion diabetisk ketoacidose blærecancer i anamnesen ikke udredt makroskopisk hæmaturi
- hypersensitivity to the active substance or to any of the excipients listed in 6.1 - cardiac failure or history of cardiac failure (NYHA stages I to IV) - hepatic impairment - diabetic ketoacidosis - current bladder cancer or a history of bladder cancer - uninvestigated macroscopic haematuria
Sådan skal De tage Pioglitazone Accord
How to take Pioglitazone Accord
EU/1/11/722/001-010 (14/28/30/50/56/84/90/98/112/196 tabletter i alu/alu-blister) EU/1/11/722/011-020 (14/28/30/50/56/84/90/98/112/196 tabletter i alu/alu-blister) EU/1/11/722/021-030 (14/28/30/50/56/84/90/98/112/196 tabletter i alu/alu-blister)
EU/1/11/722/001-010 (14/28/30/50/56/84/90/98/112/196 tablets in alu/alu blister) EU/1/11/722/011-020 (14/28/30/50/56/84/90/98/112/196 tablets in alu/alu blister) EU/1/11/722/021-030 (14/28/30/50/56/84/90/98/112/196 tablets in alu/alu blister)
Pioglitazone Accord 45 mg tabletter
Pioglitazone Accord 45 mg tablets
Hjælpestof(fer), som behandleren skal være opmærksom på: Hver tablet indeholder 74,46 mg lactosemonohydrat (se pkt.
Each tablet contains 74.46 mg of lactose monohydrate (see section 4.4).
Pioglitazone Accord 30 mg tabletter
Pioglitazone Accord 30 mg tablets
Pioglitazone Accord 15 mg tabletter Hver tablet indeholder 15 mg pioglitazon (som hydrochlorid).
Pioglitazone Accord 15 mg tablets Each tablet contains 15 mg of pioglitazone (as hydrochloride).
Pioglitazone Accord 15 mg tabletter
Pioglitazone Accord 15 mg tablets
Hjælpestof(fer), som behandleren skal være opmærksom på: Hver tablet indeholder 111,70 mg lactosemonohydrat (se pkt.
Each tablet contains 111.70 mg of lactose monohydrate (see section 4.4).
Pioglitazone Accord 15 mg tabletter er hvide til offwhite, runde, bikonvekse tabletter uden overtræk, mærket med ‘P' på den ene side og ‘15' på den anden side.
• Pioglitazone Accord 15 mg tablets are white to off white, round, biconvex, uncoated tablets debossed with ‘P' on one side and ‘15' on other side.
Pioglitazone Accord 45 mg tabletter er er hvide til offwhite, flade, runde tabletter uden overtræk, præget med ‘PIO' på den ene side og ‘45' på den anden side.
• Pioglitazone Accord 45 mg tablets are white to off white, flat, round uncoated tablets with beveled edges debossed with ‘PIO' on one side and ‘45' on the other side.
Pioglitazone Accord 30 mg tabletter Pioglitazon
Pioglitazone Accord 30 mg tablets Pioglitazone
LÆGEMIDLETS NAVN Pioglitazone Accord 45 mg tabletter Pioglitazon
NAME OF THE MEDICINAL PRODUCT Pioglitazone Accord 45 mg tablets
LÆGEMIDLETS NAVN Pioglitazone Accord 15 mg tabletter Pioglitazon
NAME OF THE MEDICINAL PRODUCT Pioglitazone Accord 15 mg tablets
Pioglitazone Accord 30 mg tabletter er hvide til offwhite, flade, runde tabletter uden overtræk, præget med ‘PIO' på den ene side og ‘30' på den anden side.
• Pioglitazone Accord 30 mg tablets are white to off white, flat, round uncoated tablets with beveled edges debossed with ‘PIO' on one side and ‘30' on the other side.
Tabletterne er hvide til offwhite, flade, runde tabletter uden overtræk, præget med ‘PIO' på den ene side og ‘45' på den anden side.
The tablets are white to off white, flat, round uncoated tablets with beveled edges debossed with ‘PIO' on one side and ‘45' on the other side.
Almene symptomer og reaktioner på administrationsstedet ødemer5
General disorders and administration site conditions
Aktivt stof: pioglitazon.
• The active substance in Pioglitazone Accord is pioglitazone.
Tabletterne er hvide til offwhite, flade, runde tabletter uden overtræk, præget med ‘PIO' på den ene side og ‘30' på den anden side.
The tablets are white to off white, flat, round uncoated tablets with beveled edges debossed with ‘PIO' on one side and ‘30' on the other side.
Hver Pioglitazone Accord 30 mg tablet indeholder 30 mg pioglitazon (som hydrochlorid).
• Each Pioglitazone Accord 30 mg tablet contains 30 mg of pioglitazone (as hydrochloride).
Tabletterne er hvide til offwhite, runde, bikonvekse, uden overtræk, præget med ‘P' på den ene side og ‘15' på den anden side.
The tablets are white to off white, round, biconvex, uncoated tablets debossed with ‘P' on one side and ‘15' on other side.
Hjælpestof(fer), som behandleren skal være opmærksom på: Hver tablet indeholder 37,24 mg lactosemonohydrat (se pkt.
Each tablet contains 37.24 mg of lactose monohydrate (see section 4.4).
Det skal De vide, før De begynder at tage Pioglitazone Accord Sådan skal De tage Pioglitazone Accord Bivirkninger
What Pioglitazone Accord is and what it is used for What you need to know before you take Pioglitazone Accord How to take Pioglitazone Accord Possible side effects
Hver Pioglitazone Accord 45 mg tablet indeholder 45 mg pioglitazon (som hydrochlorid).
• Each Pioglitazone Accord 45 mg tablet contains 45 mg of pioglitazone (as hydrochloride).
EU/1/11/722/021 14 tabletter EU/1/11/722/022 28 tabletter EU/1/11/722/023 30 tabletter EU/1/11/722/024 50 tabletter EU/1/11/722/025 56 tabletter EU/1/11/722/026 84 tabletter EU/1/11/722/027 90 tabletter EU/1/11/722/028 98 tabletter EU/1/11/722/029 112 tabletter EU/1/11/722/030 196 tabletter
EU/1/11/722/021 14 tablets EU/1/11/722/022 28 tablets EU/1/11/722/023 30 tablets EU/1/11/722/024 50 tablets EU/1/11/722/025 56 tablets EU/1/11/722/026 84 tablets EU/1/11/722/027 90 tablets EU/1/11/722/028 98 tablets EU/1/11/722/029 112 tablets EU/1/11/722/030 196 tablets
EU/1/11/722/001 14 tabletter EU/1/11/722/002 28 tabletter EU/1/11/722/003 30 tabletter EU/1/11/722/004 50 tabletter EU/1/11/722/005 56 tabletter EU/1/11/722/006 84 tabletter EU/1/11/722/007 90 tabletter EU/1/11/722/008 98 tabletter EU/1/11/722/009 112 tabletter EU/1/11/722/010 196 tabletter
EU/1/11/722/001 14 tablets EU/1/11/722/002 28 tablets EU/1/11/722/003 30 tablets EU/1/11/722/004 50 tablets EU/1/11/722/005 56 tablets EU/1/11/722/006 84 tablets EU/1/11/722/007 90 tablets EU/1/11/722/008 98 tablets EU/1/11/722/009 112 tablets EU/1/11/722/010 196 tablets
- Kontakt lægen eller apotekspersonalet, hvis en bivirkning bliver værre, eller De får bivirkninger, som ikke er nævnt her.
Tell your doctor or pharmacist if you are taking,have recently taken or might take any other medicines, including medicines obtained without a prescription.
EU/1/11/722/011 14 tabletter EU/1/11/722/012 28 tabletter EU/1/11/722/013 30 tabletter EU/1/11/722/014 50 tabletter EU/1/11/722/015 56 tabletter EU/1/11/722/016 84 tabletter EU/1/11/722/017 90 tabletter EU/1/11/722/018 98 tabletter EU/1/11/722/019 112 tabletter EU/1/11/722/020 196 tabletter
EU/1/11/722/011 14 tablets EU/1/11/722/012 28 tablets EU/1/11/722/013 30 tablets EU/1/11/722/014 50 tablets EU/1/11/722/015 56 tablets EU/1/11/722/016 84 tablets EU/1/11/722/017 90 tablets EU/1/11/722/018 98 tablets EU/1/11/722/019 112 tablets EU/1/11/722/020 196 tablets
Hver Pioglitazone Accord 15 mg tablet indeholder 15 mg pioglitazon (som hydrochlorid).
• Each Pioglitazone Accord 15 mg tablet contains 15 mg of pioglitazone (as hydrochloride).
Kontakt lægen, før De tager denne medicin, hvis lægen har fortalt Dem, at De ikke tåler visse sukkerarter.
Pioglitazone Accord contains lactose monohydrate If you have been told by your doctor that you have intolerance to some sugars, contact your doctor before taking Pioglitazone Accord.
Din læge vil give dig Ivozall en gang daglig i 5 dage.
Your doctor will give you Ivozall once every day for 5 days.
Estimater baseret på anden analyse
Estimates based on other analysis
Patienter, som overholder alle de følgende kriterier:
Patients who met each of the following criteria:
Hvis du (eller dit barn) vejer under 20 kg, kan infusionstiden være længere.
If you (or your child) weigh less than 20 kg, the infusion time may be longer.
> 24 timer
> 24 hours
Denne er normalt reversibel og synes at være dosisafhængig.
This is usually reversible and appears to be dose-dependent.
Bedste respons
Best Response
Tal med din læge om prævention.
Talk to your doctor about contraception.
PR = Partiel remission
PR = Partial remission
Koncentrat (ml)*
Concentrate (ml)*
Estimater baseret på nonkompartmental analyse (n = 14 / n = 14)
Estimates based on noncompartmental analysis (n = 14 / n = 14)
(Der forligger ingen data efter eksponering af kaniner).
(There are no exposure data in rabbits.)
Ivozall indeholder det samme aktive stof og virker på samme måde som et "referencelægemiddel", der allerede er godkendt i EU.
Ivozall contains the same active substance and works in the same way as a ‘reference medicine' already authorised in the EU.
Andre eksfoliative tilstande er også blevet indberettet.
Other exfoliative conditions have also been reported.
På grund af lægemidlets virkemåde påvirker det blodet og andre organer.
Because of the way this medicine works, it will affect your blood and other organs.
Der er dog ikke kendskab til klinisk betydningsfulde interaktioner med andre lægemidler eller laboratorieundersøgelser.
However, there are no known clinically significant interactions with other medicinal products or laboratory tests.
Ivozall kan skade både mandlige og kvindelige kønsorganer.
Ivozall may harm both male and female reproductive organs.
Leveren er et muligt organ for toksicitet.
The liver is a potential target organ for toxicity.
5,2 timer
5.2 hours
Ivozall bør derfor ikke anvendes under graviditet, og især ikke i løbet af det første trimester, med mindre det er klart nødvendigt (dvs. kun hvis den potentielle fordel for moderen opvejer den potentielle risiko for fostret).
Therefore, Ivozall should not be used during pregnancy, especially not during the first trimester, unless clearly necessary (i.e. only if the potential benefit to the mother outweighs the risk to the foetus).
Ikke kendt: C. difficile colitis
Frequency not known: C. difficile colitis
Ud fra et mikrobiologisk synspunkt bør lægemidlet bruges med det samme.
From a microbiological point of view, the product should be used immediately.
Infusionen varer 2 timer.
The infusion will be given over 2 hours.
* = se nedenfor **Alle bivirkninger forekom mindst to gange (dvs. 2 eller flere reaktioner (1,7 %)) er medtaget i denne tabel
* = see below **All adverse reactions occurring at least twice (i.e., 2 or more reactions (1.7%)) are included in this table
Individuel varighed af remission og overlevelsesdata for patienter, der opnåede CR eller CRp
Individual duration remission and survival data for patients who achieved CR or CRp
Følgelig forventes stoffet ikke at påvirke metabolismen af aktive stoffer, som er kendte substrater for disse enzymer.
As a result, it is not expected to affect the metabolism of active substances which are known substrates for these enzymes.
Se afsnittet ‘Graviditet og amning' nedenfor.
See the section ‘Pregnancy and breast-feeding' below.
Efter 24 timer er omkring 60 % udskilt uomdannet med urinen.
After 24 hours, about 60% of the dose is excreted unchanged in the urine.
Fordeling: Fordelingsvolumen (steady-state)
Volume of distribution (steady state)
Referencelægemidlet for Ivozall er godkendt under "særlige vilkår".”.
The reference medicine for Ivozall has been authorised under ‘exceptional circumstances'.
Der findes intet specifikt antidot.
No specific antidotal therapy exists.
Forhøjet kreatinin grad 3 eller 4 opstod hos 8 % af patienterne.
Grade 3 or 4 elevated creatinine occurred in 8% of patients.
Voksne (> 21 og < 65 år)
Adults (> 21 and < 65 years old)
Total remission (CR + CRp)
Overall remission (CR + CRp)
CR = Komplet remission
CR = Complete remission
Akut lymfoid leukæmi skyldes abnorm vækst af visse typer hvide blodlegemer.
Acute lymphoblastic leukaemia is caused by abnormal growth of some types of white blood cells.
Bivirkninger, der er indberettet i tiden efter markedsføring af produktet, er inkluderet i tabellen med hyppigheden “ikke kendt” (kan ikke estimeres ud fra forhåndenværende data).
Adverse reactions reported during the post-marketing period are also included in the table under the frequency category “not known” (cannot be estimated from the available data).
Medianalderen hos de behandlede patienter (37 drenge, 24 piger) var 12 år.
The median age of treated patients (37 males, 24 females) was 12 years old.
Ivozall bør ikke håndteres af gravide kvinder.
Ivozall should not be handled by pregnant women.
• Ingen tegn på blaster i kredsløb eller ekstramedullær sygdom
• No evidence of circulating blasts or extramedullary disease
Omgående seponering af lægemidlet, nøje observation og indledning af passende understøttende behandling anbefales.
Immediate discontinuation of therapy, careful observation and initiation of appropriate supportive measures are recommended.
Børn med vægt < 20 kg
Children weighing < 20 kg
På dette tidspunkt kan behandlingen genoptages med normal dosis.
At this time, treatment may be reinitiated at the full dose.
Det svarer til 3,53 % af det anbefalede maksimale daglige indtag af natrium for en voksen.
This is equivalent to 3.53% of the recommended maximum daily intake of sodium for an adult.
Under behandling med Ivozall vil din læge jævnligt tage blodprøver og udføre andre undersøgelser for at checke dit helbred.
During treatment with Ivozall, your doctor will carry out regular blood tests and other tests to monitor your health.
Respons sås hos forskellige immunfænotyper af ALL, inklusive præ-B-celle- og T-celle-ALL.
Responses were seen in different immunophenotypes of ALL, including pre-B cell and T-cell.
De 12 patienter, som opnåede total remission (CR + CRp) havde en median overlevelsestid på 66,6 uger ved skæringspunktet for dataindsamling.
The 12 patients who achieved an overall remission (CR + CRp) had a median survival time of 66.6 weeks as of the data collection cut-off date.
Børn og unge (≥ 1 år)
Children and adolescents (≥ 1 year old)
Spørg din læge til råds om, hvad du kan gøre for at beskytte dig eller fortsat kunne få børn.
Ask your doctor to explain what can be done to protect you or allow you to have a family.
amphotericin B); - andre lægemidler, også hvis der er tale om ikke-receptpligtige lægemidler.
amphotericin B); - any other medicines including those obtained without a prescription.
Dette er hyppigst forekommet inden for 30 dage efter behandlingsstart og i forbindelse med kombinationskemoterapi.
This has occurred more frequently within 30 days of treatment, and in the setting of combination chemotherapy.
Det betyder, at det grundet sygdommens sjældenhed ikke har været muligt at indhente fuldstændige oplysninger om referencelægemidlet.
This means that because of the rarity of this disease it has been impossible to get complete information on the reference medicine.
82515 Wolfratshausen Tyskland
82515 Wolfratshausen
Dets tumorbekæmpende virkning menes at kunne henføres til 3 virkemåder:
Its antitumour activity is believed to be due to 3 mechanisms:
Det er en klar, farveløs opløsning, der tilberedes og fortyndes før brug.
It is a clear colourless solution that is prepared and diluted before it is used.
Voksen population (inklusive ældre)
Adult population (including elderly)
Clofarabin var teratogent hos rotter og kaniner.
Clofarabine was teratogenic in rats and rabbits.
Systemisk clearance
Systemic clearance
De fleste af disse hypotensive episoder forekom dog hos patienter, som havde konfunderende svære infektioner.
However, the majority of these hypotensive events were reported in patients who had confounding severe infections.
• (Antal patienter med CR + antal patienter med CRp)antal valgbare patienter, der fik clofarabin
• - (Number of patients with a CR + Number of patients with a CRp) ÷ Number of eligible patients who received clofarabine
Mænd skal ligeledes anvende sikker prævention, mens de eller deres partner behandles med clofarabin.
Men must also use effective contraception while they or their partner are treated with clofarabine.
Carcinogenicitetsforsøg er ikke udført.
No carcinogenicity studies have been performed.
Clofarabin må ikke anvendes under graviditet, medmindre det er tvingende nødvendigt.
Clofarabine should not be used during pregnancy unless clearly necessary.
ANDET ORPHELIA Pharma
ORPHELIA Pharma
Der foreligger ingen data om anvendelse af clofarabin til gravide kvinder.
There are no data on the use of clofarabine in pregnant women.
Varighed af respons er konfunderet hos patienter, der fik HSCT.
Response durations are confounded in patients who received a HSCT.
Børn under 1 år
Children < 1 year old
Det vides ikke, om clofarabin eller dets metabolitter udskilles i human modermælk.
It is unknown whether clofarabine or its metabolites are excreted in human breast milk.
Længere infusionstid bør derfor overvejes hos børn, der vejer < 20 kg (se pkt.
Accordingly, longer infusion times should be considered in children weighing < 20 kg (see section 4.2).
Unge mænd og kvinder skal anvende sikker prævention under og efter behandlingen.
Young men and women must use effective contraception during and after treatment.
Desuden bør behandling med clofarabin seponeres, hvis patienten udvikler hypotension under de fem dages administration, uanset årsagen.
In addition, clofarabine treatment should be discontinued if the patient develops hypotension for any reason during the 5 days of administration.
Skønnet kreatininclearance (ml/min)
Estimated creatinine clearance (ml/min)