natgillin/translations-raw huggingface dataset:
Nedenstående regimer har været brugt hos voksne og ældre i behandlingen af fremskreden eller metastaseret colorektal cancer og gives her som eksempler.
The following regimens have been used in adults and elderly in the treatment of advanced or metastatic colorectal cancer and are given as examples.
Der findes ingen data vedrørende brug af disse kombinationer hos børn:
There are no data on the use of these combinations in children:
Regime hver 2. måned:
Bimonthly regimen:
Calciumfolinat 200 mg/ m² givet som intravenøs infusion over 2 timer, efterfulgt af 400 mg/ m² 5- fluorouracil bolus og 22 timers infusion af 5- fluorouracil (600 mg/ m²) i 2 på hinanden følgende dage, hver 2. uge dag 1 og 2.
Calcium folinate 200 mg/ m2 by intravenous infusion over two hours, followed by bolus 400 mg/ m2 of 5-FU and 22-hour infusion of 5-FU (600 mg/ m2) for 2 consecutive days, every 2 weeks on days 1 and 2.
Ugentlige regimer:
EMEA/ CPMP/ 3736/ 03 13/ 21  EMEA 2003 Weekly regimen:
Calciumfolinat 20 mg/ m² givet som i. v. bolusinjektion eller 200- 500 mg/ m² ved i. v. infusion over 2 timer, plus 500 mg/ m² 5- fluorouracil som i. v. bolusinjektion givet i midt under eller ved afslutningen af calciumfolinatinfusionen.
Calcium folinate 20 mg/ m² by bolus i. v. injection or 200 to 500 mg/ m² as i. v. infusion over a period of 2 hours plus 500 mg/ m² 5-fluorouracil as i. v. bolus injection in the middle or at the end of the calcium folinate infusion.
Månedlige regimer:
Monthly regimen:
Calciumfolinat 20 mg/ m² givet som i. v. bolusinjektion eller 200- 500 mg / m² som i. v. infusion giver over 2 timer, øjeblikkeligt efterfulgt af 370 eller 425 mg/ m² 5- fluorouracil som i. v bolusinjektion i løbet af 5 på hinanden følgende dage.
Calcium folinate 20 mg/ m² by bolus i. v. injection or 200 to 500 mg/ m² as i. v. infusion over a period of 2 hours immediately followed by 425 or 370 mg/ m² 5-fluorouracil as i. v. bolus injection during five consecutive days.
Afhængig af patientens tilstand, klinisk respons og dosisbegrænsende toksicitet som beskrevet i produktresuméet for 5- fluorouracil, kan modificering af 5- flurouracil- doseringer og behandlingsfrie intervaller være nødvendig ved kombination med 5- fluorouracil.
For the combination therapy with 5-fluorouracil, modification of the 5-fluorouracil dosage and the treatment-free interval may be necessary depending on patient condition, clinical response and dose limiting toxicity as stated in the product information of 5-fluorouracil.
En reduktion af calciumfolinatdoseringen er ikke påkrævet.
A reduction of calcium folinate dosage is not required.
Antallet gentagende cyklusser vurderes af lægen.] > EMEA/ CPMP/ 3736/ 03 13/ 20 EMEA 2003 Modgift til folinsyreantagonister trimetrexat, trimethoprim og pyrimethamin:
The number of repeat cycles used is at the discretion of the clinician.]
Trimetrexattoksicitet:
Antidote to the folic acid antagonists trimetrexate, trimethoprime, and pyrimethamine:
Calciumfolinat bør gives dagligt under behandling med trimetrexat samt i
Trimetrexate toxicity: • Prevention:
72 timer efter sidste dosis af trimetrexat.
Calcium folinate should be administered every day during treatment with trimetrexate and for 72 hours after the last dose of trimetrexate.
Calciumfolinat kan gives enten intravenøst i en dosis på 20 mg/ m² i 5- 10 minutter hver 6. time med en total daglig dosis på 80 mg/ m², eller gives oralt á 4 doser på 20 mg/ m² givet med lige store tidsintervaller.
Calcium folinate can be administered either by the intravenous route at a dose of 20 mg/ m² for 5 to 10 minutes every 6 hours for a total daily dose of 80 mg/ m², or by oral route with four doses of 20 mg/ m2 administered at equal time intervals.
Den daglige dosis af calciumfolinat bør justeres efter hæmatologisk toksicitet af trimetrexat.
Daily doses of calcium folinate should be adjusted depending on the haematological toxicity of trimetrexate.
Efter seponering af trimetrexat gives calciumfolinat 40mg/ m² i. v. hver 6. time i 3 dage.
• Overdosage (possibly occurring with trimetrexate doses above 90 mg/ m2 without concomitant administration of calcium folinate): after stopping trimetrexate, calcium folinate 40 mg/ m2 IV every 6 hours for 3 days.
Ved høje doser af pyrimethamin eller forlænget behandling med lave doser bør der
Trimethoprime toxicity: • After stopping trimethoprime, 3-10 mg/ day calcium folinate until recovery of a normal blood count.
sideløbende gives calciumfolinat 5- 50 mg dagligt afhængigt de perifere blodprøveværdier.
Pyrimethamine toxicity: • In case of high dose pyrimethamine or prolonged treatment with low doses, calcium folinate 5 to 50 mg/ day should be simultaneously administered, based on the results of the peripheral blood counts.
Kendt overfølsomhed overfor calciumfolinat eller overfor et eller flere af produktets tilsætningsstoffer.
• Known hypersensitivity to calcium folinate, or to any of the excipients. • Pernicious anaemia or other anaemias due to vitamin B12 deficiency.
Ved brug af calciumfolinat i kombination med methotrexat < [eller 5- fluorouracil >] under graviditet og amning, se pkt. 4. 6. ” Graviditet og Amning ” samt produktresumé for lægemidlerne som indeholder methotrexat < [og 5- fluorouracil >].
Regarding the use of calcium folinate with methotrexate [or 5-fluorouracil] > during pregnancy and lactation, see section 4.6, “ Pregnancy and Lactation” and the summaries of product characteristics for methotrexate- [and 5-fluorouracil-] containing medicinal products”.
Calciumfolinat bør kun bruges intramuskulært eller intravenøst og det må ikke bruges intratekalt.
Calcium folinate should only be given by intramuscular or intravenous injection and must not be administered intrathecally.
Der har været rapporteret dødsfald når folininsyre er blevet administreret intratekalt efter en intratekal overdosering med methotrexat.
When folinic acid has been administered intrathecally following intrathecal overdose of methotrexate death has been reported.
Calciumfolinat bør kun bruges sammen med methotrexat [< eller 5- fluorouracil] > under direkte tilsyn af en læge med erfaring i brug af kemoterapeutiske midler mod cancer.
General EMEA/ CPMP/ 3736/ 03 14/ 21  EMEA 2003 Calcium folinate should be used with methotrexate [or 5-fluorouracil] only under the direct supervision of a clinician experienced in the use of cancer chemotherapeutic agents.
Calciumfolinat behandling kan skjule perniciøs anæmi og andre anæmier på grund af B12- mangel.
Calcium folinate treatment may mask pernicious anaemia and other anaemias resulting from vitamin B12 deficiency.
Mange cytotoksiske lægemidler – direkte eller indirekte DNA- syntesehæmmere – medfører makrocytose (hydroxycarbamid, cytarabin, mercaptopurin, thioguanin).
Many cytotoxic medicinal products – direct or indirect DNA synthesis inhibitors – lead to macrocytosis (hydroxycarbamide, cytarabine, mecaptopurine, thioguanine).
Sådanne makrocytoser bør ikke behandles med folininsyre.
Such macrocytosis should not be treated with folinic acid.
Hos patienter med epilepsi, som behandles med fenobarbital, fenytoin, primidon og succinimider, er risikoen for hyppigere anfaldfrekvens øget på grund af reduceret plasmakoncentration af antiepileptiske lægemidler.
In epileptic patients treated with phenobarbital, phenytoine, primidone, and succinimides there is a risk to increase the frequency of seizures due to a decrease of plasma concentrations of anti-epileptic drugs.
4. 5).
Clinical monitoring, possibly monitoring of the plasma concentrations and, if necessary, dose adaptation of the anti-epileptic drug during calcium folinate administration and after discontinuation is recommended (see also section 4.5 Interactions).
Calciumfolinat kan forstærke toksiciteten af 5- fluorouracil, specielt hos ældre eller svækkede patienter.
[Calcium folinate/ 5-fluorouracil Calcium folinate may enhance the toxicity risk of 5-fluorouracil, particularly in elderly or debilitated patients.
Disse kan være dosisbegrænsende.
The most common manifestations are leucopenia, mucositis, stomatitis and/ or diarrhoea, which may be dose limiting.
Når calciumfolinat og 5- fluorouracil kombineres, skal 5 - fluorouracil doseringen reduceres i større grad ved toksicitet end når 5- fluorouracil bruges alene.
When calcium folinate and 5-fluorouracil are used in combination, the 5- fluorouracil dosage has to be reduced more in cases of toxicity than when 5-fluorouracil is used alone.
Kombineret 5- fluorurasil/ calciumfolinat behandling bør ikke initieres eller forsættes hos patienter med symptomer med GIgastrointestinal toksicitet, uden hensyn til sværhedsgraden, før disse symptomer er helt forsvundet.
Combined 5-fluorouracil/ calcium folinate treatment should neither be initiated nor maintained in patients with symptoms of gastrointestinal toxicity, regardless of the severity, until all of these symptoms have completely disappeared.
Da diarre kan være et symptom på gastrointestinal toksicitet, må patienter med diarre omhyggeligt monitoreres indtil symptomerne helt er forsvundet, da en hurtig klinisk forværring kan opstå og medføre døden.
Because diarrhoea may be a sign of gastrointestinal toxicity, patients presenting with diarrhoea must be carefully monitored until the symptoms have disappeared completely, since a rapid clinical deterioration leading to death can occur.
Hvis diarre og/ eller stomatitis optræder, anbefales det at reducere dosis af 5 - fluorouracil indtil symptomerne er fuldstændig forsvundet.
If diarrhoea and/ or stomatitis occur, it is advisable to reduce the dose of 5-FU until symptoms have fully disappeared.
Ældre og patienter som på grund af sygdom har lav fysisk aktivitet, er specielt udsat for sådan toksicitet.
Especially the elderly and patients with a low physical performance due to their illness are prone to these toxicities.
Derfor bør der tages særlig hensyn ved behandling af disse patienter.
Therefore, particular care should be taken when treating these patients.
Hos ældre patienter og patienter som forudgående har været i strålebehandling anbefales det, at starte med en reduceret dosis af 5- fluoruracil.
In elderly patients and patients who have undergone preliminary radiotherapy, it is recommended to begin with a reduced dosage of 5-fluorouracil.
Calciumfolinat må ikke blandes med 5- fluoruracil i samme i. v. injektion eller infusion.
Calcium folinate must not be mixed with 5-fluorouracil in the same IV injection or infusion.
Calciumniveauerne bør monitoreres hos patienter som får kombinationsbehandling med 5- fluorouracil og calciumfolinat, og calciumtilskud bør gives hvis calciumniveauerne er for lave.] >
Calcium levels should be monitored in patients receiving combined 5-fluorouracil/ calcium folinate treatment and calcium supplementation should be provided if calcium levels are low.]
For specifikke detaljer om reduktion af methotrexat, se produktresumé for methotrexat.
Calcium folinate/ methotrexate For specific details on reduction of methotrexate toxicity refer to the SPC of methotrexate.
Calciumfolinat har ingen effekt på ikke- hæmatologiske toksiciteter af methotrexat så som nefrotoksicitet fra methotrexat og eller metabolitudfældning i nyrerne.
Calcium folinate has no effect on non-haematological toxicities of methotrexate such as the nephrotoxicity resulting from methotrexate and/ or metabolite precipitation in the kidney.
Patienter som har oplevet forsinket tidlig methotrexat elimination udvikler sandsynligvis reversibel nyresvigt og alle toksiciteter associeret med methotrexat (se venligst produktresumé for methotrexat).
Patients who experience delayed early methotrexate elimination are likely to develop reversible renal failure and all toxicities associated with methotrexate (please refer to the SPC for methotrexate).
Tidligere eksisterende - eller methotrexat- induceret nyreinsufficiens er potentielt associeret med forsinket udskillelse af methotrexat, og kan øge behovet for højere doser eller en forlænget anvendelse af calciumfolinat.
The presence of preexisting- or methotrexate-induced renal insufficiency is potentially associated with delayed excretion of methotrexate and may increase the need for higher doses or more prolonged use of calcium folinate.
Store doser calciumfolinat skal undgås, da de kan svække antitumoraktiviteten af methotrexat, specielt i CNS- tumorer hvor calciumfolinat akkumuleres ved gentagne cyklusser.
Excessive calcium folinate doses must be avoided since this might impair the antitumour activity of methotrexate, especially in CNS tumours where calcium folinate accumulates after repeated courses.
Resistens mod methotrexat som følge af nedsat membrantransport indikerer også resistens mod folininsyre- rescue, da begge disse lægemidler benytter samme transportsystem.
EMEA/ CPMP/ 3736/ 03 15/ 21  EMEA 2003 Resistance to methotrexate as a result of decreased membrane transport implies also resistance to folinic acid rescue as both medicinal products share the same transport system.
En utilsigtet overdosis med en folatantagonist, så som methotrexat, bør behandles som en medicinsk katastrofe.
An accidental overdose with a folate antagonist, such as methotrexate, should be treated as a medical emergency.
Når tidsintervallet mellem administration af methotrexat og calciumfolinat- rescue øges, aftager den toksicitetshæmmende effekt af calciumfolinat.
As the time interval between methotrexate administration and calcium folinate rescue increases, calcium folinate effectiveness in counteracting toxicity decreases.
Muligheden for at patienten tager anden medicin der interagere med methotrexat (f. eks. medicin der påvirker methotrexat eliminering eller som binder sig til serumalbumin) bør altid overvejes, når der observeres unormale laboratoriefund eller når klinisk toksicitet observeres.
The possibility that the patient is taking other medications that interact with methotrexate (eg, medications which may interfere with methotrexate elimination or binding to serum albumin) should always be considered when laboratory abnormalities or clinical toxicities are observed.
4. 5 Interaktion med andre lægemidler og andre former for interaktion EMEA/ CPMP/ 3736/ 03 15/ 20 EMEA 2003 Når calciumfolinat gives sammen med en folinsyreantagonist (f. eks. co- trimoxazol (trimethoprim + sulfamethoxazol), pyrimetamin), kan effekten af folinsyreantagonisten enten reduceres eller neutraliseres fuldstændig.
When calcium folinate is given in conjunction with a folic acid antagonist (e. g. cotrimoxazole, pyrimethamine) the efficacy of the folic acid antagonist may either be reduced or completely neutralised.
4. 4 og 4. 8).
Calcium folinate may diminish the effect of anti-epileptic substances: phenobarbital, primidone, phenytoine and succinimides, and may increase the frequency of seizures (a decrease of plasma levels of enzymatic inductor anticonvulsant drugs may be observed because the hepatic metabolism is increased as folates are one of the cofactors) (see also sections 4.4 and 4.8).
4. 2, 4. 4 og 4. 8] >.
Concomitant administration of calcium folinate with 5-fluorouracil has been shown to enhance the efficacy and toxicity of 5-fluorouracil [(see sections 4.2, 4.4 and 4.8)].
Graviditet Der er ikke udført adækvate og kontrollerede kliniske studier på gravide eller ammende kvinder.
Pregnancy There are no adequate and well-controlled clinical studies conducted in pregnant or breast-feeding women.
Der er ikke udført nogle formelle reproduktionstoksiske dyrestudier med calciumfolinat.
No formal animal reproductive toxicity studies with calcium folinate have been conducted.
Der er ingen indikationer som tyder på at folinsyre inducerer skadelige effekter hvis det administreres under en graviditet.
There are no indications that folic acid induces harmful effects if administered during pregnancy.
Ved graviditet skal methotrexat kun administreres på strenge indikationer, hvor fordelene ved behandlingen for moderen vurderes mod de mulige farer for fostret.
During pregnancy, methotrexate should only be administered on strict indications, where the benefits of the drug to the mother should be weighed against possible hazards to the foetus.
Hvis behandling med methotrexat eller andre folatantagonister alligevel forekommer til trods for graviditet eller amning (se venligst produktresumé for det aktuelle lægemiddel), findes der ingen begrænsninger med hensyn til brugen af calciumfolinat for at nedsætte toksiciteten eller modvirke effekterne.
Should treatment with methotrexate or other folate antagonists take place despite pregnancy or lactation, there are no limitations as to the use of calcium folinate to diminish toxicity or counteract the effects.
Se venligst produktresumé for lægemidler som indeholder beskrivelser af methotrexat, andre folatantagonister < [og 5- fluorouracil] >.
[5-fluorouracil use is generally contraindicated during pregnancy and contraindicated during breast- feeding; this applies also to the combined use of calcium folinate with 5-fluorouracil.] Please refer also to the summaries of product characteristics for methotrexate-, other folate antagonists [and 5-fluorouracil-] containing medicinal products.
Amning Det vides ikke om calciumfolinat udskilles i human brystmælk.
Lactation It is not known whether calcium folinate is excreted into human breast milk.
Calciumfolinat kan bruges under amning, når det vurderes at være nødvendig i overensstemmelse med den terapeutiske indikation.
Calcium folinate can be used during breast feeding when considered necessary according to the therapeutic indications.
Det er ikke bevist at calciumfolinat påvirker evnen til at føre bil eller betjene maskiner.
There is no evidence that calcium folinate has an effect on the ability to drive or use machines.
< [Begge indikationer:]
[Both therapeutic indications:]
Allergiske reaktioner, inkluderet anafylaktiske reaktioner og urtecaria.
EMEA/ CPMP/ 3736/ 03 16/ 21  EMEA 2003 Very rare (< 0.01%): allergic reactions, including anaphylactoid reactions and urticaria.
Søvnløshed, agitation og depression efter høje doser.
Psychiatric disorders Rare (0.01-0.1%): insomnia, agitation and depression after high doses.
Gastrointestinale lidelser efter høje doser.
Gastrointestinal disorders Rare (0.01-0.1%): gastrointestinal disorders after high doses.
Sygdomme i nervesystemet Sjælden (0, 01- 0, 1%):
Neurological disorders Rare (0.01-0.1%): increase in the frequency of attacks in epileptics (see also section 4.5 Interactions...).
4. 5 Interaktioner …) EMEA/ CPMP/ 3736/ 03 16/ 20 EMEA 2003 Almene lidelser og reaktioner på indgivelsesstedet Usædvanlig (0, 1- 1%):
General disorders and administration site conditions Uncommon (0.1-1%): fever has been observed after administration of calcium folinate as solution for injection.
< [Kombinationsbehandling med 5- flurouracil:
[Combination therapy with 5-fluorouracil:
Sikkerhedsprofilen afhænger generelt af det anvendte 5- fluorouracilregime pga. den øgede 5 - fluorouracilinducerede toksicitet:
Generally, the safety profile depends on the applied regimen of 5-fluorouracil due to enhancement of the 5-fluorouracil induced toxicities:
Opkast og kvalme
Gastrointestinal disorders Very common (> 10%): vomiting and nausea
Almene lidelser og reaktioner på indgivelsesstedet Meget almindelig (> 10%):
General disorders and administration site conditions Very common (> 10%):
(Alvorlig) slimhindetoksicitet.
(severe) mucosal toxicity.
Ingen øgning af andre 5- fluorouracil inducerede toksiciteter (f. eks. neurotoksicitet).
No enhancement of other 5-fluorouracil induced toxicities (e. g. neurotoxicity).
Ugentlige regimer:
Weekly regimen:
Diarré med højere grad af toksicitet, og dehydrering med sygehusindlæggelse for behandling og endda med død til følge.] >
Gastrointestinal disorders Very common (> 10%): diarrhoea with higher grades of toxicity, and dehydration, resulting in hospital admission for treatment and even death.]
Der er ikke indberettet følger hos patienter, som har modtaget signifikant mere calciumfolinat end den anbefalede dosis.
There have been no reported sequelae in patients who have received significantly more calcium folinate than the recommended dosage.
Imidlertid kan usædvanlig store mængder af calciumfolinat ophæve den kemoterapeutiske effekt af folinsyreantagonister.
However, excessive amounts of calcium folinate may nullify the chemotherapeutic effect of folic acid antagonists.
< [Skulle overdosering af en kombination af 5- fluoruracil og calciumfolinat opstå, bør instruktionerne for 5- fluorouracil følges. >]
[Should overdosage of the combination of 5-fluorouracil and calcium folinate occur, the overdosage instructions for 5-FU should be followed.]
Midler der modvirker toksicitet ved cytostatikabehandling; ATC - kode:
Detoxifying agents for antineoplastic treatment; ATC code:
V03AF03.
V03AF03
Calciumfolinat er et calciumsalt af 5- formyl tetrahydrofolinsyre.
Calcium folinate is the calcium salt of 5-formyl tetrahydrofolic acid.
Det er en aktiv metabolit af folinsyre og et essentielt co- enzym for nukleinsyresyntese i cytotoksisk behandling.
It is an active metabolite of folinic acid and an essential coenzyme for nucleic acid synthesis in cytotoxic therapy.
Calciumfolinat anvendes ofte for at reducere toksiciteten og modvirke effekten af folatantagonister så som methotrexat.
EMEA/ CPMP/ 3736/ 03 17/ 21  EMEA 2003 Calcium folinate is frequently used to diminish the toxicity and counteract the action of folate antagonists, such as methotrexate.
Calciumfolinat og folatantagonister bruger samme membrantransporter og konkurrerer om transport ind i cellerne, sådan at folatantagonist efflux stimuleres.
Calcium folinate and folate antagonists share the same membrane transport carrier and compete for transport into cells, stimulating folate antagonist efflux.
Calciumfolinat beskytter også cellerne fra effekterne af folatantagonister ved at genopbygge det mindskede folatlager.
It also protects cells from the effects of folate antagonist by repletion of the reduce folate pool.
Calciumfolinat fungerer som en pre- reduceret kilde for H4- folat; det kan derfor gå uden om folatantagonistblokkaderne, og være med til at fungere som en kilde for forskellige co- enzymformer af folinsyre.
Calcium folinate serves as a pre-reduced source of H4 folate; it can therefore bypass folate antagonist blockage and provide a source for the various coenzyme forms of folic acid.
EMEA/ CPMP/ 3736/ 03 17/ 20 EMEA 2003 [< Calciumfolinat bruges ofte i biokemisk modulering af fluoropyridin (5- FU) for at fremme dets cytotoksiske aktivitet.
[Calcium folinate is also frequently used in the biochemical modulation of fluoropyridine (5-FU) to enhance its cytotoxic activity.
Calciumfolinat fremmer TS- hæmningen, ved at øge det intracellulære folatlager, og dermed stabilisere 5- FU – TS- komplekset og øge aktiviteten.] >
5-FU inhibits thymidylate synthase (TS), a key enzyme involved in pyrimidine biosynthesis, and calcium folinate enhances TS inhibition by increasing the intracellular folate pool, thus stabilising the 5FU-TS complex and increasing activity.]
Calciumfolinat kan også administreres intravenøst for af forhindre og behandle folatmangel når dette ikke kan forebygges eller korrigeres ved administration af oral folinsyre.
Finally intravenous calcium folinate can be administered for the prevention and treatment of folate deficiency when it cannot be prevented or corrected by the administration of folic acid by the oral route.
Dette kan være tilfældet ved total parenteral ernæring og alvorlig malabsorptionslidelser.
This may be the case during total parenteral nutrition and severe malabsorption disorders.
Det er også indiceret ved behandling af megaloblastisk anæmi pga. folinsyremangel, når oral administration ikke er mulig.
It is also indicated for the treatment of megaloblastic anaemia due to folic acid deficiency, when oral administration is not feasible.
Absorption Efter en intramuskulær administration af en vandig opløsning, er systemisk biotilgængelighed sammenlignelig med en intravenøs administration.
Absorption Following intramuscular administration of the aqueous solution, systemic availability is comparable to an intravenous administration.
Der opnås imidlertid lavere maksimal serumkoncentration (Cmax).
However, lower peak serum levels (Cmax) are achieved.