natgillin/translations-raw huggingface dataset:
Check udløbsdatoen på æsken og på injektionssprøjten (se Fig.
Check the expiration date on the box and syringe (See Fig.
Chiesi Farmaceutici S.P.A, Via Palermo 26/A 43122 Parma, Italien
Chiesi Farmaceutici S.P.A, Via Palermo 26/A 43122 Parma, Italy
Chiesi Farmaceutici S.p.A. Sími: + 39 0521 2791
Chiesi Pharma AB Tlf: +46 8 753 35 20
Chiesi Farmaceutici S.p.A. Tel: + 39 0521 2791
Chiesi Pharma AB Tlf: +46 8 753 35 20
Chiesi Farmaceutici S.p.A. Tlf: + 39 0521 2791
Chiesi Pharma AB Tlf: +46 8 753 35 20
Chiesi Pharmaceuticals B.V. Tel: 31 0 70 413 20 80
Chiesi Pharmaceuticals B.V. Tel: + 31 0 70 413 20 80
Chiesi Pharmaceuticals GmbH Tel: + 43 1 4073919
Chiesi Pharmaceuticals GmbH Tel: + + 43 1 4073919
Chiesi Poland Sp. z o.o.
Chiesi Poland Sp. z.o.o.
Child- Pugh Class A eller B).
Child-Pugh Class A and B).
Child-Pugh Class A og B) i betragtning af risikoen for øget Esbriet-eksponering.
Child-Pugh Class A and B) given the potential for increased Esbriet exposure.
Child-Pugh Class B) blev Esbriet- eksponeringen øget med 60 %.
Child-Pugh Class B), Esbriet exposure was increased by 60%.
Child-Pugh-klasser
CP classes
Child-Pugh-score kan blive påvirket af faktorer relateret til behandling (dvs. indirekte hyperbilirubinæmi, nedsat albumin) og kan ikke nødvendigvis tilskrives den hepatiske dekompensation.
The Child-Pugh scoring may be affected by factors related to treatment (i.e. indirect hyperbilirubinemia, decreased albumin) and not necessarily attributable to hepatic decompensation.
Chiron Quantiplex assay (LLOD 0,7 Meq/ml)
Chiron Quantiplex assay (LLOD 0.7 Meq/ml)
Chiron Quantiplex assay (LLOD 0.7 Meq/ml).
Chiron Quantiplex assay (LLOD 0.7 Meq/ml)
Chlamydophila arter
Chlamydophila spp.
Chlamydophila felis (905 stamme) .......................................................................................  103,0 EID50
Chlamydophila felis (905 strain) ..........................................................................................  103.0 EID50
Chlamydophila felis (905 stamme) ........................................................................................>103,0 EID50
Chlamydophila felis (905 strain) ..........................................................................................  103.0 EID50
Chlamydophila felis (905 stamme) ........................................................................................>103,0 EID50
Chlamydophila felis (905 strain)..........................................................................................  103.0 EID50
Chloasma kan lejlighedsvist optræde, især hos kvinder med chloasma gravidarum i anamnesen.
Chloasma may occasionally occur, especially in women with a history of chloasma gravidarum.
chloasma, hypertrikose
chloasma, hypertrichosis
Chlorambucil blev givet oralt, 0,5 mg/kg kropsvægt, på 1. dag og 15. dag i alle behandlingsserierne (1-6).
Chlorambucil was given orally at 0.5 mg/kg body weight on Day 1 and Day 15 of all treatment cycles (1 to 6).
Chlorambucil N118
Chlorambucil N=118
chloramphenicol probenecid
chloramphenicol, probenecid,
Chlorcresol 1 mg/ml
Chlorocresol 1 mg/ml
Chlorcresol 2,0 mg.
Chlorocresol 2.0 mg.
Chlorididentifikation Positiv
Chloride identification Positive
Chloroquin bindes til den toksiske hæmgruppe (som stammer fra patientens hæmoglobin) i malariaparasitten, og forhindrer afgiftningen via et polymerisationstrin.
Chloroquine binds to toxic haeme (derived from the patient’s haemoglobin) within the malaria parasite, preventing its detoxification via a polymerisation step.
chloroquin og halofantrin, der anvendes til behandling af malaria.
chloroquine, halofantrine used to treat malaria.
chloroquin, halofantrin, clarithromycin, haloperidol, methadon, moxifloxacin - lægemidler, der kan have en uønsket virkning på hjertets funktion
chloroquine, halofantrine, clarithromycin, haloperidol, methadone, moxifloxacin - medicines that may have an unwanted effect on the function of the heart;
chloroquin, pamaquin, primaquin, kinin – anvendes til behandling af malaria
Chloroquine, pamaquine, primaquine, quinine - used to treat malaria
chlorpromazin og andre phenothiazin-derivater (til behandling af svære psykiske lidelser)
chlorpromazine and other phenothiazine derivatives (to treat severe mental disorders)
Chlorpromazin, chlorprothixen, haloperidol (lægemidler mod psykiske forstyrrelser, som hører til gruppen kaldet phenothiaziner, thioxanthener og butyrophenoner).
Chlorpromazine, chlorprothixene, haloperidol (medicines to treat mental disorders and belong to the group called phenothiazines, thioxanthenes, butyrophenones).
chlorpropamid (anvendes ved behandling af diabetes)
chlorpropamide (used to treat diabetes)
CHMP afgjor- de, at fordelene ved NexoBrid overstiger risiciene, og anbefalede udstedelse af en markedsføringstilla- delse for NexoBrid.
The CHMP decided that NexoBrid’s benefits are greater than its risks and recommended that it be given marketing authorisation.
CHMP afgjorde derfor, at fordelene ved Constella over- stiger risiciene, og anbefalede udstedelse af markedsføringstilladelse for Constella.
The CHMP therefore decided that Constella’s benefits are greater than its risks and recommended that it be given marketing authorisation.
CHMP afgjorde derfor, at fordelene ved Cuprymina overstiger risiciene, og anbefalede udstedelse af markedsføringstilladelse for Cuprymina.
Therefore, the CHMP decided that Cuprymina’s benefits are greater than its risks and recommended that it be given marketing authorisation.
CHMP afgjorde derfor, at fordelene ved Fortacin overstiger risiciene, og anbefalede udstedelse af markedsføringstilladelse med gyldighed i EU.
The CHMP therefore decided that Fortacin’s benefits are greater than its risks and recommended that it be approved for use in the EU.
CHMP afgjorde derfor, at fordelene ved Imlygic overstiger risiciene, og anbefalede udstedelse af markedsføringstilladelse til anvendelse i EU.
Thus, CHMP decided that Imlygic’s benefits are greater than its risks and recommended that it be approved for use in the EU.
CHMP afgjorde derfor, at fordelene ved MACI overstiger risiciene, og anbefalede udstedelse af markedsføringstilladelse til anvendelse i EU.
The CHMP therefore concluded that MACI’s benefits are greater than its risks and recommended that it be approved for use in the EU.
CHMP afgjorde derfor, at fordelene ved Neofordex overstiger risiciene, og anbefalede udstedelse af markedsføringstilladelse til anvendelse i EU.
The CHMP therefore decided that Neofordex’s benefits are greater than its risks and recommended that it be approved for use in the EU.
CHMP afgjorde derfor, at fordelene ved Picato overstiger risiciene, og anbefalede udstedelse af markedsføringstilladelse for Picato.
The CHMP therefore decided that Picato’s benefits are greater than its risks and recommended that it be given marketing authorisation.
CHMP afgjorde derfor, at fordelene ved Sancuso overstiger risiciene, og anbefalede udstedelse af markedsføringstilladelse for Sancuso.
Therefore, the CHMP decided that Sancuso’s benefits are greater than its risks and recommended that it be given marketing authorisation.
CHMP afgjorde derfor, at fordelene ved Zaltrap samlet set opvejer risiciene, og anbefalede udstedelse af markedsføringstilladelse for Zaltrap.
Overall, the CHMP decided that Zaltrap’s benefits are greater than its risks and recommended that it be given marketing authorisation.
CHMP afgjorde derfor, at fordelene ved Zyclara overstiger risiciene, og anbefalede udstedelse af mar- kedsføringstilladelse for Zyclara.
The CHMP therefore decided that Zyclara’s benefits are greater than its risks and recommended that it be given marketing authorisation.
CHMP afgjorde, at fordelene ved Nplate opvejer risiciene og anbefalede udstedelse af en markedsføringstilladelse for Nplate.
The CHMP decided that Nplate’s benefits are greater than its risks and recommended that it be given marketing authorisation.
CHMP afgjorde, at fordelene ved Selincro overstiger risiciene, og anbefalede udstedelse af en markedsføringstilladelse for Selincro.
The CHMP decided that Selincro’s benefits are greater than its risks and recommended that it be given marketing authorisation.
CHMP afgjorde, at fordelene ved Yondelis opvejer risiciene, og anbefalede udstedelse af en markedsføringstilladelse for Yondelis.
The CHMP concluded that Yondelis’s benefits are greater than its risks and recommended that it be given marketing authorisation.
CHMP anbefaler, at betingelserne for markedsføringstilladelsen ændres.
The CHMP recommends that the terms of the Marketing Authorisation(s) should be varied.
CHMP anbefaler, at betingelserne for markedsføringstilladelsen ændres.
The CHMP recommends that the terms of the Marketing Authorisations should be varied.
CHMP anbefaler, at betingelserne for markedsføringstilladelsen(-erne) skal ændres.
The CHMP recommends that the terms of the marketing authorisation(s) should be varied.
CHMP anbefaler, at betingelserne for markedsføringstilladelsen/-erne ændres.
The CHMP recommends that the terms of the Marketing Authorisation should be varied.
CHMP anbefaler, at betingelserne for markedsføringstilladelsen/-erne ændres.
The CHMP recommends that the terms of the Marketing Authorisations should be varied.
CHMP anbefaler, at betingelserne for markedsføringstilladelsen/-tilladelserne ændres.
The CHMP recommends that the terms of the marketing authorisation should be varied.
CHMP anbefaler, at betingelserne for markedsføringstilladelserne ændres.
The CHMP recommends that the terms of the marketing authorisation(s) should be varied.
CHMP anbefaler, at vilkårene for markedsføringstilladelsen ændres.
The CHMP recommends that the terms of the Marketing Authorisation should be varied.
CHMP bemærkede derudover, at der ikke var alvorlige eller uventede sikkerhedsmæssige problemer med Eylea.
The CHMP further noted that there were no major or unexpected safety concerns with Eylea.
CHMP bemærkede desuden, at der ikke var større sikkerhedsmæssige problemer med Incruse, idet bivirkningerne kunne behandles og svarede til bivirkningerne af andre antimuskarine bronkodilaterende lægemidler.
The CHMP also noted that there were no major safety concerns with Incruse, with side effects being manageable and similar to other antimuscarinic bronchodilator medicines.
CHMP bemærkede det uopfyldte behandlingsbehov hos patienter med multipelt myelom, hvor de foreliggende behandlinger ikke længere virker.
The CHMP noted the unmet medical need for patients with multiple myeloma who no longer respond to the available therapies.
CHMP bemærkede endvidere, at det, at lægemidlet tages en gang dagligt, kan gøre det lettere for patienterne at overholde behandlingen.
The CHMP also noted that the fact that the medicine is used once a day may help patients to comply with their treatment.
CHMP bemærkede imidlertid, at der kun var begrænsede data om de mere langsigtede virkninger af lægemidlet, og at virksomheden skulle fremlægge yderligere data.
The CHMP also noted, however, that there were limited data on the longer-term effects of the medicine and that further data should be provided by the company.
CHMP bemærkede ligeledes, at der manglede effektive alternative behandlinger.
It also noted the lack of effective alternative treatments.
CHMP bemærkede også fraværet af effektive alternative behandlingsmuligheder for patienter, som allerede har prøvet standardbehandlingerne.
The CHMP also noted the lack of effective alternative treatments for patients who have already tried standard treatments.
CHMP bemærkede også, at der er behov for flere undersøgelser til at fastlægge fordelene ved Lynparza, dets virkning på den totale overlevelse og dets langsigtede sikkerhed.
The CHMP also noted that more studies are needed to further confirm the benefit of Lynparza, its effect on overall survival and its long-term safety.
CHMP bemærkede også, at kombinationen af dapagliflozin og metformin i én enkelt tablet kan være en ekstra behandlingsmulighed for patienter med type 2-sukkersyge, og at dette kan hjælpe patienterne med at overholde behandlingen bedre.
The CHMP also noted that giving the combination of dapagliflozin and metformin as a single tablet could provide an additional treatment option for patients with type 2 diabetes, and may improve adherence to treatment.
CHMP bemærkede også, at kombinationen ikke medfører nogen uventede bivirkninger.
The CHMP also noted that the combination does not cause any unexpected side effects.
CHMP bemærkede, at Arzerra var effektivt til behandling af patienter med kronisk lymfatisk leukæmi (både ikke tidligere behandlede patienter og patienter, som ikke tidligere havde responderet på behandling med fludarabin og alemtuzumab.
The CHMP noted that Arzerra was shown to be effective at treating patients with CLL (both previously untreated patients and patients who had not responded to previous treatment with fludarabine and alemtuzumab).
CHMP bemærkede, at Atripla skal tages på tom mave for at forhindre visse bivirkninger, men at dette kan resultere i en lav tenofovirkoncentration i blodet.
The CHMP noted that Atripla needs to be taken on an empty stomach to prevent certain side effects, but that this could result in low tenofovir levels in the blood.
CHMP bemærkede, at bedringen med Senshio svarede til den, der opnås ved påføring af østrogenholdige lægemidler i skeden.
The CHMP noted that the degree of improvement seen with Senshio was comparable to that seen with oestrogen treatments that are applied to the vagina.
CHMP bemærkede, at børn er mest udsat, efterfulgt af unge, og at der ikke findes nogen anden godkendt vaccine i EU mod meningitis forårsaget af denne gruppe bakterier.
The CHMP noted that young children are most at risk, followed by adolescents, and that there is no other vaccine authorised in the EU for meningitis caused by this group of the bacterium.
CHMP bemærkede, at Constella havde vist klinisk relevant gavnlig virkning hos patienter med langva- rig (op til seks måneder) irritabel tyktarm med forstoppelse.
The CHMP noted that Constella has been shown to have clinically relevant, beneficial effects in patients with IBS with constipation in the long term (for up to six months).
CHMP bemærkede, at Cyramza udviste klar fordel i form af forlænget overlevelse hos patienter med kræft i mavesækken eller i overgangen mellem mavesækken og spiserøret, når det blev givet sammen med paclitaxel.
The CHMP noted that the benefit of Cyramza in prolonging the lives of gastric and gastro-oesophageal junction cancer patients was clearly demonstrated when Cyramza was given with paclitaxel.
CHMP bemærkede, at DepoCyte havde vist sig effektiv til behandling af lymfomatøs meningitis ved sammenligning med standardformuleringen af cytarabin, og at det kunne forbedre patienternes livskvalitet, eftersom færre intratekale injektioner er påkrævet.
The CHMP noted that DepoCyte had shown effectiveness in lymphomatous meningitis when compared with the standard formulation of cytarabine, and that it could improve patients’ quality of life because fewer intrathecal injections are needed.
CHMP bemærkede, at der var behov for nye typer KOL-behandling, og at hovedundersøgelserne viste en beskeden fordel ved Daxas hos patienter med svær KOL.
The CHMP noted that there was a need for new COPD treatments and that the main studies showed a modest benefit of Daxas in patients with severe COPD.
CHMP bemærkede, at der var et behov for hurtigtvirkende smertestillende lægemidler til behandling af gennembrudssmerter hos kræftpatienter.
The CHMP noted that there was a need for fast-acting pain medicines for breakthrough pain in patients with cancer.
CHMP bemærkede, at det var blevet påvist, at Yervoy forbedrer overlevelsen ved en tilstand, hvor de samlede overlevelsesrater er lave.
The CHMP noted that Yervoy has been shown to improve survival in a condition where overall survival rates are low.
CHMP bemærkede, at en igangværende klinisk undersøgelse vil kunne bekræfte den langsigtede effektivitet.
The CHMP noted that an on-going clinical study will provide confirmation on the long-term effectiveness.
CHMP bemærkede, at Enurev Breezhaler havde en beskeden, men relevant gavnlig virkning hos patienterne med hensyn til forbedring af lungefunktionen og også viste sig at forbedre symptomerne på KOL.
The CHMP noted that Enurev Breezhaler had a modest but relevant benefit for patients in terms of improving lung function, and was also seen to improve the symptoms of COPD.
CHMP bemærkede, at Esbriet havde en beskeden virkning på reduktionen af sygdommens udvikling, målt ved hjælp af FVC, uden at der var nogen alvorlige risici for patienterne.
The CHMP noted that Esbriet had a modest effect on slowing down the progression of the disease, as measured by FVC, without serious risks for patients.
CHMP bemærkede, at fordelene ved Bydureon, f.eks. dets indvirkning på reduktionen af HbA1c- niveauerne, svarer godt til fordelene ved sammenligningslægemidlerne, og at dets bivirkninger kan behandles.
The CHMP noted that the benefits of Bydureon, such as its effect on reducing the levels of HbA1c, compare well with those of comparator medicines and that its side effects are manageable.
CHMP bemærkede, at fordelene ved Gazyvaro var klart påvist til forlængelse af overlevelsen hos patienter med kronisk lymfatisk leukæmi og follikulært lymfom uden forværring af deres sygdomme.
The CHMP considered that the benefit of Gazyvaro in prolonging the survival of CLL and FL patients before their disease worsened was clearly demonstrated.
CHMP bemærkede, at fordelene ved Thymanax med hensyn til behandling af depression kan være mindre end dem, der ses med andre antidepressive lægemidler.
The CHMP noted that Thymanax’s benefits in terms of treating depression might be lower than seen with other antidepressants.
CHMP bemærkede, at fordelene ved Valdoxan med hensyn til behandling af depression kan være mindre end dem, der ses med andre antidepressive lægemidler.
The CHMP noted that Valdoxan’s benefits in terms of treating depression might be lower than seen with other antidepressants.
CHMP bemærkede, at HER2-positiv brystkræft er en aggressiv kræftform for brystkræft, der udgør omkring et ud af hver fem tilfælde.
The CHMP noted that HER2-positive breast cancer is an aggressive form of breast cancer which occurs in around one in five cases.
CHMP bemærkede, at Hizentra kan forebygge alvorlige bakterieinfektioner hos PID-patienter gennem ugentlige injektioner, som kan gives i patientens hjem, og at bivirkningerne ikke er hyppige eller svære.
The CHMP noted that Hizentra can prevent serious bacterial infections in PID patients through weekly injections which may be given at home, while the side effects are not frequent or severe.
CHMP bemærkede, at hos børn var immunsystemets respons på Prevenar 13 sammenlignelig med responsen på Prevenar, der allerede er godkendt i EU til beskyttelse af børn mod S. pneumoniae.
The CHMP noted that in children the immune system’s response to Prevenar 13 was comparable to that of Prevenar, which is already authorised for the protection of children against S. pneumoniae in the EU.
CHMP bemærkede, at Iclusig viste sig at være effektivt til behandling af patienter med CML eller Ph+ ALL, for hvem der kun findes begrænsede behandlingsmuligheder.
The CHMP noted that Iclusig was shown to be an effective treatment for those patients with CML or Ph+ ALL who have limited treatment options.
CHMP bemærkede, at injektioner med Ozurdex kun forårsager mindre trauma på øjeæblet, og at det øgede tryk i øjet anses som værende håndterligt.
The CHMP noted that Ozurdex injection causes only minor trauma to the eyeball and the increase in intraocular pressure is considered to be manageable.
CHMP bemærkede, at kombinationen af dapagliflozin og metformin i én enkelt tablet derudover udgør en ekstra behandlingsmulighed for patienter med type 2-sukkersyge, og kan gøre det lettere for patienterne at følge behandlingen.
The CHMP also noted that giving the combination of dapagliflozin and metformin as a single tablet could provide an additional treatment option for patients with type 2 diabetes, and may improve adherence to treatment.
CHMP bemærkede, at Plenadren opnåede tilfredsstillende cortisolniveauer under behandlingen af patienter med binyreinsufficiens.
The CHMP noted that Plenadren achieved satisfactory levels of cortisol during the treatment of patients with adrenal insufficiency.
CHMP bemærkede, at Reyataz' virkning var påvist hos patienter på mindst 3 måneder, og som vejede mindst 5 kg.
The CHMP considered that Reyataz’s effectiveness had been shown in patients aged at least 3 months and weighing at least 5 kg.
CHMP bemærkede, at Seebri Breezhaler havde en beskeden, men relevant gavnlig virkning hos patienterne med hensyn til forbedring af lungefunktionen og også viste sig at forbedre symptomerne på KOL.
The CHMP noted that Seebri Breezhaler had a modest but relevant benefit for patients in terms of improving lung function, and was also seen to improve the symptoms of COPD.
CHMP bemærkede, at Tovanor Breezhaler havde en beskeden, men relevant gavnlig virkning hos patienterne med hensyn til forbedring af lungefunktionen og også viste sig at forbedre symptomerne på KOL.
The CHMP noted that Tovanor Breezhaler had a modest but relevant benefit for patients in terms of improving lung function, and was also seen to improve the symptoms of COPD.
CHMP bemærkede, at undersøgelserne viste, at Dexdor svarede godt til andre sedativa og vil være nyttigt som et yderligere lægemiddel til opnåelse af lettere sedationsniveauer hos egnede patienter.
The CHMP noted that the studies showed that Dexdor compared well with other sedatives and will serve as an additional alternative medicine for achieving lighter levels of sedation in suitable patients.
CHMP bemærkede, at Voncento havde vist sig at være effektivt til at behandle og forebygge blødning hos patienter med hæmofili A samt hos patienter med von Willebrands sygdom.
noted that Voncento was shown to be effective in treating and preventing bleeding in patients with haemophilia A as well as in patients with von Willebrand disease.
CHMP bemærkede, at Votubia har vist sig at reducere størrelsen af hjernetumorer hos voksme og børn, der lider af tuberøs sklerose, og at dette forventes at nedbringe tegnene og symptomerne på SEGA, såsom anfald, ophobning af vand i hovedet og forhøjet tryk i hjernen.
The CHMP noted that Votubia has been shown to reduce the size of the brain tumours in adults and children with tuberous sclerosis and that this is expected to reduce the signs and symptoms of SEGA such as seizures, hydrocephalus (accumulation of fluid in the brain), and increased pressure within the brain.
CHMP bemærkede, at Zinforo i forsøgsmodeller havde vist sig at være virksomt mod bakterier, som andre betalactam-antibiotika ikke virker mod, såsom MRSA.
The CHMP noted that Zinforo had shown activity in experimental models against certain bacteria against which other antibiotics belonging to the beta-lactam class do not work such as MRSA.
CHMP bemærkede, at Zytiga i kombination med prednison eller prednisolon gav forbedret overlevelse sammenlignet med placebo hos patienter, hvis sygdom er forværret til trods for kastrationsbehandling og kemoterapi med docetaxel.
The CHMP noted that Zytiga in combination with prednisone or prednisolone improved survival compared with placebo in patients whose disease had got worse despite castration treatment and chemotherapy with docetaxel.
CHMP besluttede derfor, at fordelene ved Adcetris opvejer risiciene, og anbefalede udstedelse af en markedsføringstilladelse for Adcetris.
Therefore, the CHMP decided that Adcetris’s benefits are greater than its risks and recommended that it be given marketing authorisation.
CHMP besluttede derfor, at fordelene ved Betmiga opvejer risiciene, og anbefalede udstedelse af en markedsføringstilladelse for Betmiga.
The CHMP therefore decided that Betmiga’s benefits are greater than its risks and recommended that it be given marketing authorisation.
CHMP besluttede derfor, at fordelene ved Bexsero opvejer risiciene, og anbefalede udstedelse af en markedsføringstilladelse.
Therefore, the CHMP decided that Bexsero’s benefits are greater than its risks and recommended that it be given marketing authorisation.