natgillin/translations-raw huggingface dataset:
3 Hovedpine blev rapporteret hos 11,5% af patienterne behandlet med bosentan og 9,8% af patienterne behandlet med placebo. 
3 Headache was reported in 11.5% of patients on bosentan and 9.8% of patients on placebo.
Der er udført to randomiserede, dobbeltblinde, multicenter, placebokontrollerede studier med henholdsvis 122 (studie AC-052-401 [RAPIDS-1]) og 190 (studie AC-052-331 [RAPIDS-2]) voksne patienter med systemisk sklerose og fingersårssygdom (enten akutte fingersår eller fingersår i anamnesen inden for det foregående år). 
Two randomised, double-blind, multi-centre, placebo-controlled studies have been conducted in 122 (study AC-052-401 [RAPIDS-1]) and 190 (study AC-052-331 [RAPIDS-2]) adult patients with systemic sclerosis and digital ulcer disease (either ongoing digital ulcers or a history of digital ulcers within the previous year).
Samtidig anvendelse af STAYVEER og ciclosporin A er kontraindiceret (se pkt. 
Concomitant use of STAYVEER and cyclosporine A is contraindicated (see sections 4.3 and 4.5).
Hos patienterne over 2 år (n=22) var den daglige eksponering 8.820 ng·t/ml; AUCτ var 4.410 ng·t/ml (CV 58%). 
In the patients above 2 years (n = 22) the daily exposure was 8,820 ng·h/mL; AUCτ was 4,410 ng·h/mL (CV: 58%).
Unormal leverfunktionstest (se pkt. 
Abnormal liver function test (see section 4.4)
For hvide polyethylenflasker af høj densitet, skal det anvendes inden for 30 dage efter anbrud. 
For white high-density polyethylene bottles, use within 30 days after the first opening.
4 år For hvide polyethylenflasker af høj densitet skal indholdet anvendes inden for 30 dage efter anbrud. 
4 years For white high-density polyethylene bottles, use within 30 days after the first opening.
En samlet analyse af ikke-kontrollerede pædiatriske studier udført hos PAH-patienter med bosentan 32 mg dispergible tabletter (FUTURE 1/2, FUTURE 3/forlængelse) omfattede i alt 100 børn, der blev behandlet med bosentan 2 mg/kg to gange dagligt (n=33), 2 mg/kg tre gange dagligt (n=31) eller 4 mg/kg to gange dagligt (n=36). 
A pooled analysis of uncontrolled paediatric studies conducted in PAH with the bosentan 32 mg dispersible tablet formulation (FUTURE 1/2, FUTURE 3/Extension) included a total of 100 children treated with bosentan 2 mg/kg twice daily (n = 33), 2 mg/kg three times daily (n = 31), or 4 mg/kg twice daily (n = 36).
De skal ikke holde op med at tage STAYVEER, medmindre Deres læge har bedt Dem om det. Deres læge kan bede Dem reducere dosis over nogle få dage, før De stopper helt med behandlingen. 
Your doctor may tell you to reduce the dose over a few days before stopping completely.
Hos patienter i alderen mellem 3 måneder og 2 år var den daglige eksponering 7.879 ng·t/m; AUCτ var 3.939 ng·t/ml; (CV 72%). 
In patients between 3 months and 2 years the daily exposure was 7,879 ng·h/mL; AUCτ was 3,939 ng·h/mL (CV: 72%).
Hud og subkutane væv 
Skin and subcutaneous disorders Common
I studie AC-052-401udviklede patienter i bosentan-gruppen i løbet af de 16 uger dobbeltblind behandling gennemsnitligt 1,4 nye fingersår vs. 2,7 nye fingersår i placebogruppen (p= 0,0042). 
In study AC-052-401, during 16 weeks of double-blind therapy, patients in the bosentan group developed a mean of 1.4 new digital ulcers vs 2.7 new digital ulcers in the placebo group (p = 0.0042).
Ciclosporin: Samtidig administration af STAYVEER og ciclosporin (en calcineurinhæmmer) er kontraindiceret (se pkt. 
Cyclosporine A: Co-administration of STAYVEER and cyclosporine A (a calcineurin inhibitor) is contraindicated (see section 4.3).
2 Der har været rapporteret overfølsomhedsreaktioner hos 9,9% af patienterne behandlet med bosentan og hos 9,1% af patienterne behandlet med placebo. 
2 Hypersensitivity reactions were reported in 9.9% of patients on bosentan and 9.1% of patients on placebo.
Glibenclamid: Samtidig administration af bosentan 125 mg to gange dagligt i 5 dage reducerede plasmakoncentrationen af glibenclamid (et CYP3A4-substrat) med 40% med potentiel betydelig reduktion af den hypoglykæmiske virkning. 
Glibenclamide: Co-administration of bosentan 125 mg twice daily for 5 days decreased the plasma concentrations of glibenclamide (a CYP3A4 substrate) by 40%, with potential significant decrease of the hypoglycaemic effect.
Dosisjustering er ikke nødvendig til patienter, der er i dialysebehandling (se pkt. 
No dose adjustment is required in patients undergoing dialysis (see section 5.2).
Bosentan elimineres gennem galden efter metabolisering i leveren via cytochrom P450-isoenzymer CYP2C9 og CYP3A4. 
Bosentan is eliminated by biliary excretion following metabolism in the liver by the cytochrome P450 isoenzymes, CYP2C9 and CYP3A4.
Hovedpine3 
Headache3
Bosentan metaboliseres ved hjælp af CYP2C9 og CYP3A4. 
Bosentan is metabolised by CYP2C9 and CYP3A4.
Behandling med bosentan har været associeret med dosisafhængig stigning i leveraminotransferaser og fald i hæmoglobinkoncentration (se pkt. 
Treatment with bosentan has been associated with dose-dependent elevations in liver aminotransferases and decreases in haemoglobin concentration (see section 4.4).
Behandling bør kun påbegyndes og ledes af en læge, som har erfaring inden for behandling af PAH eller systemisk sklerose. 
Treatment with STAYVEER should only be started and monitored by a doctor who has experience in the treatment of PAH or systemic sclerosis.
Behandling med bosentan har været forbundet med dosisrelateret fald i hæmoglobinkoncentrationen (se pkt. 
Treatment with bosentan has been associated with dose-related decreases in haemoglobin concentration (see section 4.8).
I FUTURE-4-studiet, der omfattede 13 nyfødte med PPHN, der blev behandlet med bosentan 2 mg/kg to gange dagligt i under 10 dage (interval 0,5-10,0 dage), var der ingen tilfælde af leveraminotransferaser ≥ 3 × ULN under behandlingen, men der indtrådte ét tilfælde af hepatitis 3 dage efter, bosentanbehandlingen var afsluttet. 
In the FUTURE-4 study including 13 neonates with PPHN treated with bosentan 2 mg/kg twice daily for less than 10 days (range 0.5-10.0 days), there were no cases of liver aminotransferases ≥ 3 × ULN
STAYVEER kan skade det ufødte barn. 
STAYVEER may harm the development of the foetus.
Amning frarådes under behandling med STAYVEER. 
Breast-feeding is not recommended during treatment with STAYVEER.
Hvis aminotransferaseniveauer retableres til de samme niveauer som inden behandlingen, skal det overvejes at reintroducere STAYVEER i henhold til nedenstående betingelser. 
If the aminotransferase levels return to pre-treatment values reintroducing STAYVEER according to the conditions described below should be considered.
STAYVEER 62,5 mg filmovertrukne tabletter PVC/PE/PVDC/aluminium-blisterpakninger, der indeholder 14 filmovertrukne tabletter. 
STAYVEER 62.5 mg film-coated tablets PVC/PE/PVDC/aluminium-blisters containing 14 film-coated tablets.
Hvis aminotransferaseniveauer retableres til de samme niveauer som inden behandlingen, skal det overvejes at fortsætte eller reintroducere STAYVEER i henhold til nedenstående betingelser. 
If the aminotransferase levels return to pre-treatment values continuing or re-introducing STAYVEER according to the conditions described below should be considered.
Simvastatin: Samtidig administration af bosentan 125 mg to gange dagligt i 5 dage medførte en reduktion af plasmakoncentrationen af simvastatin (et CYP3A4-substrat) og dets aktive β-hydroxysyremetabolit med henholdsvis 34% og 46%. 
Simvastatin: Co-administration of bosentan 125 mg twice daily for 5 days decreased the plasma concentrations of simvastatin (a CYP3A4 substrate) and its active β-hydroxy acid metabolite by 34% and 46%, respectively.
5 Ødem eller væskeretention blev rapporteret hos 13,2% af patienterne behandlet med bosentan og 10,9% af patienterne behandlet med placebo. 
5 Oedema or fluid retention was reported in 13.2% of patients on bosentan and 10.9% of patients on placebo.
- STAYVEER 125 mg filmovertrukne tabletter: Aktivt stof: bosentan som monohydrat. 
- STAYVEER 125 mg film-coated tablets: The active substance is bosentan as monohydrate.
Omhyggelig afvejning af fordele/risici bør foretages under hensyntagen til, at levertoksiciteten er dosisafhængig (se pkt. 
A careful benefit/risk assessment should be made, taking into consideration that the liver toxicity is dose dependent (see sections 4.4 and 5.1).
Rifampicin: Samtidig administration af bosentan 125 mg 2 gange dagligt og rifampicin, en potent inducer af CYP2C9 og CYP3A4, til 9 raske forsøgspersoner i 7 dage reducerede plasmakoncentrationen af bosentan med 58%; i et enkelt tilfælde op til næsten 90%. 
Rifampicin: Co-administration in 9 healthy subjects for 7 days of bosentan 125 mg twice daily with rifampicin, a potent inducer of CYP2C9 and CYP3A4, decreased the plasma concentrations of bosentan by 58%, and this decrease could achieve almost 90% in an individual case.
STAYVEER 125 mg filmovertrukne tabletter PVC/PE/PVDC/aluminium-blisterpakninger, der indeholder 14 filmovertrukne tabletter. 
STAYVEER 125 mg film-coated tablets PVC/PE/PVDC/aluminium-blisters containing 14 film-coated tablets.
Blodprøver for leverfunktion 
Blood tests for liver function
De skal anvende en barrieremetode - f.eks. kondom, pessar eller svangerskabsforebyggende svamp i skeden - sammen med den hormonelle prævention. 
You need to use a barrier form of birth control - like a condom, diaphragm or vaginal sponge - in addition to any of these kinds of hormonal birth control.
Sjældne (kan forekomme hos op til 1 og 1.000 personer): 
Rare (may affect up to one in 1000 people):
4.5), som vil kunne påvirke virkningen af antiretroviral behandling, bør disse patienter også monitoreres omhyggeligt med hensyn til deres hiv-infektion. 
Due to the potential for interactions related to the inducing effect of bosentan on CYP450 (see section 4.5), which could affect the efficacy of antiretroviral therapy, these patients should also be monitored carefully regarding their HIV infection.
• Kvinder i den fertile alder, som ikke benytter pålidelige præventionsmetoder (se pkt. 
• Women of childbearing potential who are not using reliable methods of contraception (see sections 4.4, 4.5 and 4.6)
Denne interaktion skyldes med stor sandsynlighed ritonavirs hæmning af transportprotein-medieret optagelse i hepatocytter og af CYP3A4, idet bosentans clearance reduceres herved. 
Inhibition by ritonavir of transport protein-mediated uptake into hepatocytes and of CYP3A4, thereby reducing the clearance of bosentan, most likely causes this interaction.
Meget almindelige bivirkninger (kan forekomme hos flere end 1 ud af 10 personer): 
Very common (may affect more than one in 10 people):
STAYVEER-behandling bør initieres med en dosis på 62,5 mg 2 gange dagligt i 4 uger og derefter øges til vedligeholdelsesdosis 125 mg 2 gange dagligt. 
STAYVEER treatment should be initiated at a dose of 62.5 mg twice daily for 4 weeks and then increased to the maintenance dose of 125 mg twice daily.
Spørg lægen eller på apoteket, hvis der er noget, De er i tvivl om eller føler Dem usikker på. 
Check with your doctor or pharmacist if you are not sure.
Omhyggelig afvejning af fordele/risici bør foretages under hensyntagen til bosentans levertoksicitet (se pkt. 
A careful benefit/risk assessment should be made, taking into consideration the liver toxicity of bosentan (see sections 4.4 and 4.8).
Se patientadvarselskortet (i pakken med STAYVEER-tabletter) for mere information om alle disse prøver. 
For all these tests please refer also to the Patient Alert Card (inside your pack of STAYVEER tablets).
Systemisk sklerose med eksisterende fingersår 
Systemic sclerosis with ongoing digital ulcer disease
Systemisk sklerose med fingersårssygdom 
Systemic sclerosis with digital ulcer disease
STAYVEER 62,5 mg filmovertrukne tabletter STAYVEER 125 mg filmovertrukne tabletter 
STAYVEER 62.5 mg film-coated tablets STAYVEER 125 mg film-coated tablets
Æsker med 56 eller 112 filmovertrukne tabletter. 
Cartons contain, 56 or 112 film-coated tablets.
- STAYVEER 62, 5 mg filmovertrukne tabletter: Aktivt stof: bosentan som monohydrat. 
- STAYVEER 62.5 mg film-coated tablets: The active substance is bosentan as monohydrate.
For yderligere oplysninger se pkt. 
For further details please refer to section 4.5.
Det tilhører gruppen af lægemidler, der kaldes ”endothelinreceptor-antagonister”. 
STAYVEER therefore causes blood vessels to expand and belongs to the class of medicines called “endothelin receptor antagonists”.
STAYVEER 62,5 mg filmovertrukne tabletter Hver filmovertrukket tablet indeholder 62,5 mg bosentan (som monohydrat). 
STAYVEER 62.5 mg film-coated tablets Each film-coated tablet contains 62.5 mg bosentan (as monohydrate).
Der er ikke påvist en fordelagtig virkning af STAYVEER på opheling af eksisterende fingersår. 
STAYVEER has not been shown to have a beneficial effect on the healing of existing digital ulcers.
Er De i tvivl, så spørg lægen eller på apoteket. 
- If you have any further questions, please ask your doctor or pharmacist.
Hos voksne patienter bør behandling med STAYVEER påbegyndes med en dosis på 62,5 mg to gange dagligt i 4 uger, hvorefter dosis forhøjes til en vedligeholdelsesdosis på 125 mg to gange dagligt. 
In adult patients, STAYVEER treatment should be initiated at a dose of 62.5 mg twice daily for 4 weeks and then increased to the maintenance dose of 125 mg twice daily.
Det kan ikke udelukkes, at dette kan påvirke din evne til at gøre en kvinde gravid. 
It cannot be excluded that this may affect your ability to father a child. Talk to your doctor if you have any questions or concerns about this.
STAYVEER 62,5 mg filmovertrukne tabletter er orange-hvide, runde filmovertrukne tabletter med ”62,5” på den ene side. 
STAYVEER 62.5 mg film-coated tablets are orange-white, round film-coated tablets with “62,5” on one side.
Blodprøver for blodmangel 
Blood tests for anaemia
• Tilbageløb af mavesyre til spiserøret (gastroøsofageal reflukssygdom) 
• Gastrooesophageal reflux disease (acid reflux)
STAYVEER 125 mg filmovertrukne tabletter Hver filmovertrukket tablet indeholder 125 mg bosentan (som monohydrat). 
STAYVEER 125 mg film-coated tablets Each film-coated tablet contains 125 mg bosentan (as monohydrate).
STAYVEER 125 mg filmovertrukne tabletter Orange-hvide, ovale, bikonvekse, filmovertrukne tabletter, med “125” præget på den ene side. 
STAYVEER 125 mg film-coated tablets Orange-white, oval, biconvex, film-coated tablets, embossed with “125” on one side.
Æsker indeholder 56 eller 112 filmovertrukne tabletter (STAYVEER 62,5 mg filmovertrukne tabletter). 
Cartons contain 56 or 112 film coated tablets (STAYVEER 62.5 mg film-coated tablets).
4.4, 4.5 og 4.6) 
For further information see sections 4.5 and 4.6.
STAYVEER 62,5 mg tabletter bosentan 
STAYVEER 62.5 mg tablets bosentan
Ikke almindelige (kan forekomme hos op til 1 ud af 100 personer): 
Uncommon (may affect up to one in 100 people):
Risikoen for leverdysfunktion kan også øges, når der indgives lægemidler, som hæmmer galdesalteksportpumpen, f.eks. rifampicin, glibenclamid og ciclosporin (se pkt. 
Liver dysfunction risk may also be increased when medicinal products that are inhibitors of the bile salt export pump, e.g., rifampicin, glibenclamide and cyclosporine A (see sections 4.3 and 4.5), are co-administered with bosentan, but limited data are available.
STAYVEER 125 mg filmovertrukne tabletter er orange-hvide, ovale filmovertrukne tabletter med ”125” på den ene side. 
STAYVEER 125 mg film-coated tablets are orange-white, oval film-coated tablets with “125” on one side.
Levercirrose, leversvigt1 
Liver cirrhosis, liver failure1
STAYVEER 125 mg tabletter bosentan 
STAYVEER 125 mg tablets bosentan
Pakningsstørrelser og yderligere oplysninger STAYVEER indeholder 
Contents of the pack and other information What STAYVEER contains
Sådan skal De tage STAYVEER 
How to take STAYVEER
STAYVEER 62,5 mg filmovertrukne tabletter Orange-hvide, runde, bikonvekse, filmovertrukne tabletter, med “62,5” præget på den ene side. 
STAYVEER 62.5 mg film-coated tablets Orange-white, round, biconvex, film-coated tablets, embossed with “62,5” on one side.
4.4 og 4.6) 
• Pregnancy (see sections 4.4 and 4.6)
Bosentan behandlingen reducerede symptomerne på PAH. 
A reduction in symptoms of PAH was observed with bosentan treatment.
Nov _____ Apr ______ Aug ______ Dec _____ 
Nov _____
mavesmerter, gulsot, usædvanlig apati eller træthed, influenza-lignende syndrom (arthralgia, myalgia, 
In the event of associated clinical symptoms of liver injury, i.e., nausea, vomiting, fever, abdominal pain, jaundice, unusual lethargy or fatigue, flu-like syndrome (arthralgia, myalgia, fever), treatment must be stopped and re-introduction of STAYVEER is not to be considered.
Der bør tages passende forholdsregler for kvinder i den fertile alder (se pkt. 
Appropriate precautions must be taken for women of childbearing potential (see sections 4.3, 4.4 and 4.6).
Almindelige bivirkninger (kan forekomme hos op til 1 ud af 10 personer): 
Common (may affect up to one in 10 people):
STAYVEER 62,5 mg filmovertrukne tabletter bosentan 
STAYVEER 62.5 mg film-coated tablets bosentan
STAYVEER 125 mg filmovertrukne tabletter bosentan 
STAYVEER 125 mg film-coated tablets bosentan
Hver tablet indeholder 62,5 mg bosentan (som monohydrat). 
Each tablet contains 62.5 mg of bosentan (as monohydrate).
• Moderat til stærkt nedsat leverfunktion, dvs. Child-Pugh klasse B eller C (se pkt. 
• Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 • Moderate to severe hepatic impairment, i.e., Child-Pugh class B or C (see section 5.2)
Æsker med 56 filmovertrukne tabletter (STAYVEER 125 mg filmovertrukne tabletter). 
Cartons contain 56 film-coated tablets (STAYVEER 125 mg film-coated tablets).
Ødem, væskeretention5 
Oedema, fluid retention5
Hver tablet indeholder 125 mg bosentan (som monohydrat). 
Each tablet contains 125 mg of bosentan (as monohydrate).
Hver filmovertrukket tablet indeholder 62,5 mg bosentan (som monohydrat) 
Each film-coated tablet contains 62.5 mg bosentan (as monohydrate)
• En patient i bosentangruppen fik konstateret behandlingssvigt (behov for EMCO iht. 
• One patient in the bosentan group had treatment failure (need for ECMO as per protocol definition), which was declared based on increasing Oxygenation Index values within 8 h after the first study drug dose.
Hver filmovertrukket tablet indeholder 125 mg bosentan (som monohydrat) 
Each film-coated tablet contains 125 mg bosentan (as monohydrate)
STAYVEER er kontraindiceret til patienter med moderat til svært nedsat leverfunktion (se pkt. 
STAYVEER is contraindicated in patients with moderate to severe liver dysfunction (see sections 4.3, 4.4 and 5.2).
5.1 og 5.2). 
No recommendation on a posology can be made (see sections 5.1 and 5.2).
Jan ______ Maj ______ Sep _____ Feb ______ Jun _____ 
Jun ______
Derfor vil lægen regelmæssigt, mens De er i behandling med STAYVEER, tage blodprøver for at undersøge, om der sker ændringer i Deres leverfunktion. 
During treatment with STAYVEER, your doctor will arrange for regular blood tests to check for changes in your liver function.
((Forside)) 
((Front cover))
Hos patienter med flere andre sygdomme og i behandling med andre lægemidler har der i perioden efter markedsføring været rapporteret sjældne tilfælde af uforklarlig levercirrose efter langvarig behandling med STAYVEER. 
In the post-marketing period rare cases of unexplained hepatic cirrhosis were reported after prolonged therapy with STAYVEER in patients with multiple co-morbidities and therapies with medicinal products.
Æsker med 56 filmovertrukne tabletter (STAYVEER 62,5 mg filmovertrukne tabletter). 
Cartons contain 56 film-coated tablets (STAYVEER 62.5 mg film-coated tablets).
Glyceroldibehenat 
Breast-feeding
Hæmoglobin 
Haemoglobin
Derefter vil Deres læge sædvanligvis råde Dem til at tage en tablet à 125 mg to gange dagligt, afhængigt af hvordan De reagerer på STAYVEER. 
The treatment in adults is usually started for the first 4 weeks with 62.5 mg twice daily (morning and evening), from then your doctor will usually advise you to take a 125 mg tablet twice daily, depending on how you react to STAYVEER.
Tørremidlet må ikke sluges 
Do not swallow the desiccant
Magnesiumstearat 
Glycerol dibehenate Magnesium stearate
Anæmi, nedsat hæmoglobin (se pkt. 
Anaemia, haemoglobin decrease, (see section 4.4)
Hvis De opdager et eller flere af disse tegn, skal De omgående fortælle det til Deres læge. 
If any of these apply to you, tell your doctor.
Det skal De vide, før De begynder at tage STAYVEER Sådan skal De tage STAYVEER Bivirkninger 
What STAYVEER is and what it is used for What you need to know before you take STAYVEER How to take STAYVEER
I den samlede analyse af 100 PAH-børn fra de ikke-kontrollerede pædiatriske studier FUTURE 1/2 og FUTURE 3/forlængelse blev der set stigning i leveraminotransferaser til ≥ 3 × ULN hos 2% af patienterne. 
FUTURE 3/Extension, elevations in liver aminotransferases ≥ 3 × ULN were observed in 2% of patients.
Hvis De vil have yderligere oplysninger om STAYVEER, skal De henvende Dem til den lokale repræsentant: 
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
Ingen af studierne påviste virkning af bosentan på ophelingen af fingersår. 
No effect of bosentan on time to healing of digital ulcers was observed in either study.
Den anbefalede dosis beregnes på baggrund af patientens højde og vægt. 
The recommended dose is calculated using the patient's height and weight.
Det kan desuden anvendes som vedligeholdelsesbehandling hos patienter, der har fået platinbaseret kemoterapi 
It can also be used as a maintenance treatment in patients who have received a platinum-based chemotherapy.
Den fuldstændige EPAR og resuméet af risikostyringsplanen for Pemetrexed Fresenius Kabi findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports. 
The full EPAR for Pemetrexed Fresenius Kabi can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Pemetrexed Fresenius Kabi. 
This is a summary of the European public assessment report (EPAR) for Pemetrexed Fresenius Kabi.
Udvalget anbefalede, at Pemetrexed Fresenius Kabi godkendes til anvendelse i EU. 
The Committee recommended that Pemetrexed Fresenius Kabi be approved for use in the EU.
Udvalget for Lægemidler til Mennesker (CHMP) konkluderede, at det i overensstemmelse med EU's krav er påvist, at Pemetrexed Fresenius Kabi er sammenligneligt med Alimta. 
The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Pemetrexed Fresenius Kabi has been shown to be comparable to Alimta.
Det betyder, at Pemetrexed Fresenius Kabi er identisk med et "referencelægemiddel", som allerede er godkendt i Den Europæiske Union (EU), og som hedder Alimta. 
This means that Pemetrexed Fresenius Kabi is similar to a ‘reference medicine' already authorised in the European Union (EU) called Alimta.
I kroppen omdannes pemetrexed til en aktiv form, der blokerer de enzymer, der medvirker ved dannelsen af nukleotider (byggestenene i dna og rna, cellernes genetiske materiale). 
In the body, pemetrexed is converted into an active form that blocks the activity of the enzymes that are involved in producing ‘nucleotides' (the building blocks of DNA and RNA, the genetic material of cells).
Der krævedes ingen supplerende undersøgelser, eftersom Pemetrexed Fresenius Kabi er et generisk lægemiddel, der indgives ved infusion og indeholder det samme aktive stof som referencelægemidlet Alimta. 
No additional studies were needed as Pemetrexed Fresenius Kabi is a generic medicine that is given by infusion and contains the same active substance as the reference medicine, Alimta.
Pemetrexed Fresenius Kabi er et kræftlægemiddel til behandling af to typer af lungekræft: 
Pemetrexed Fresenius Kabi is a cancer medicine used to treat two types of lung cancer:
Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Pemetrexed Fresenius Kabi? 
What measures are being taken to ensure the safe and effective use of Pemetrexed Fresenius Kabi?