FrancophonIA/ELRC3.0 huggingface dataset:
English: 4 to 12 ml pump
Danish: 4 til 12 ml pumpe
English: The product should not enter watercourses as this may be dangerous for fish and other aquatic organisms.
Danish: Kriptazen må ikke udledes i vandløb, da dette kan være farligt for fisk og andre organismer i vandet.
English: The bioavailability of the drug in the calf following single oral administration is about 80%.
Danish: Biotilgængeligheden af lægemidlet i kalve efter en enkel oral indgift er ca. 80 %.
English: Halofuginone lactate is a salt whose antiprotozoal properties and efficacy against Cryptosporidium parvum have been demonstrated both in in vitro conditions and in artificial and natural infections.
Danish: Halofuginonlactat er et salt hvis antiprotozo-egenskaber og virkning mod Cryptosporidium parvum er blevet demonstreret både in vitro og ved kunstige og naturlige infektioner.
English: Not for use in animals from which milk is produced for human consumption.
Danish: Må ikke anvendes til dyr, hvis mælk anvendes til konsum
English: - Wear protective gloves while handling the product.
Danish: - Brug beskyttelseshandsker ved håndtering af præparatet.
English: The plasmatic concentrations of halofuginone after repeated oral administrations are comparable to the pharmacokinetic pattern after single oral treatment.
Danish: Plasmakoncentrationen af halofuginon er efter gentagen oral indgift sammenlignelig med det farmakokinetiske mønster efter enkel oral behandling.
English: Unchanged halofuginone is the major component in the tissues.
Danish: Uomdannet halofuginon er hovedkomponenten i vævene.
English: 4 ml pump
Danish: 4 ml pumpe
English: United Kingdom Virbac Ltd,
Danish: Virbac Ltd,
English: The active substance, halofuginone, is an antiprotozoal agent of the quinazolinone derivatives group (nitrogenous polyheterocycles).
Danish: Det aktive stof, halofuginon, er et antiprotozomiddel af quinazolinon derivatgruppen (nitrogenous polyheterocycles).
English: Once broached, use by …
Danish: Efter åbning anvendes inden…
English: Administration should start in the first 24 to 48 hours of age.
Danish: Behandlingen skal starte inden for 24 til 48 timer efter fødslen.
English: Carton with bottle only Refill
Danish: Æske kun med flaske Refill
English: Cattle (newborn calves).
Danish: Kvæg (nyfødte kalve).
English: Tartrazine (E 102)
Danish: Tartrazin (E102)
English: Special precautions to be taken by the person administering the veterinary medicinal product to animals: - People with known hypersensitivity to the active substance or any of the excipients should administer the veterinary medicinal product with caution.
Danish: Særlige forholdsregler der skal træffes af personer, der administrerer lægemidlet til dyr: - Personer med kendt overfølsomhed over for det aktive stof eller et af hjælpestofferne bør administrere veterinærlægemidlet med forsigtighed.
English: NOTE: The package leaflet on the market shall mention either the 4 ml pump or the 4 to 12 ml pump or the refill bottle without a pump as appropriate.
Danish: BEMÆRK: Indlægssedlen til den markedsførte pakning vil omtale enten 4 ml pumpen eller 4-12 ml pumpen eller re-fill flasken uden pumpe.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE Outer carton
Danish: OPLYSNINGER, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE Yderkarton
English: For oral use in calves after feeding.
Danish: Til oral anvendelse hos kalve efter fodring.
English: Pharmacotherapeutic group: Other antiprotozoal agents, halofuginone.
Danish: Farmakoterapeutisk gruppe: Andre antiprotozomidler, halofuginon.
English: Benzoic acid (E 210) Lactic acid (E 270) Tartrazine (E 102) Water, Purified
Danish: Benzoesyre (E210) Mælkesyre (E270) Tartrazin (E102) Vand, destilleret
English: If product remains in the bottle, leave the pump attached until further use.
Danish: Hvis der er lægemiddel tilbage i flasken, bør pumpen forblive på indtil videre brug.
English: Marker residue Animal species MRLs
Danish: Farmakologisk aktive stof Restmarkør Dyrearter MRL Målvæv
English: - People with known hypersensitivity to the active substance or any of the excipients should administer the veterinary medicinal product with caution.
Danish: - Personer med kendt overfølsomhed over for det aktive stof eller et af hjælpestofferne bør administrere veterinærlægemidlet med forsigtighed.
English: The compound has a cryptosporidiostatic effect on Cryptosporidium parvum.
Danish: Stoffet har en cryptosporidiostatisk virkning på Cryptosporidium parvum.
English: Should clinical signs of overdosing occur, the treatment must be stopped immediately and the animal fed unmedicated milk or milk replacer.
Danish: I tilfælde af tegn på overdosering stoppes behandlingen straks og kalven fodres med umedicineret mælk eller mælkeerstatning.
English: MARKETING AUTHORISATION NUMBERS EU/2/18/234/001-006
Danish: EU/2/18/234/001-006
English: For lighter or heavier animals, a precise calculation should be performed (2 ml/10 kg bw).
Danish: For lettere eller tungere kalve laves en præcis beregning af dosis (2 ml/10 kg).
English: Shelf-life after first opening the immediate packaging: 6 months.
Danish: Opbevaringstid efter første åbning af den indre emballage: 6 måneder.
English: Antiparasitic agents/ Agents acting against protozoa
Danish: Antiparasitære lægemidler / Midler mod protozer
English: Magyarország VIRBAC HUNGARY KFT Szent Istvàn krt.11.II/21., HU-1055 Budapest Teл: +36703387177
Danish: VIRBAC HUNGARY KFT Szent Istvàn krt.11.II/21., HU-1055 Budapest Teл: +36703387177
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE Bottle of 490 ml or 980 ml
Danish: OPLYSNINGER, DER SKAL ANFØRES PÅ DEN INDRE EMBALLAGE Flaske med 490 eller 980 ml
English: Do not use in cases of hypersensitivity to the active substance or to any of the excipients.
Danish: Må ikke bruges i tilfælde af overfølsomhed over for det aktive stof eller andre hjælpestoffer.
English: 8) Continue using until the bottle is empty.
Danish: 8) Flasken anvendes indtil den er tom.
English: The dosage is: 100 μg of halofuginone / kg bw, once a day for 7 consecutive days; i.e. 2 ml of Kriptazen / 10 kg bw, once a day for 7 consecutive days.
Danish: Dosering er: 100 µg halofuginon / kg kropsvægt, 1 gang dagligt i 7 på hinanden følgende dage, svarende til 2 ml Kriptazen / 10 kg kropsvægt, 1 gang dagligt i 7 på hinanden følgende dage.
English: 7) Continue using until the bottle is empty.
Danish: 7) Flasken anvendes indtil den er tom.
English: 3) Remove the protector cap from the tip of the nozzle of the pump.
Danish: 3) Fjern beskyttelseshætten fra spidsen af pumpens mundstykke.
English: An increase in the level of diarrhoea has been observed in very rare cases in treated animals.
Danish: En forværring af diarréen hos behandlede dyr er set i meget sjældne tilfælde.
English: Meat and offal: 13 days.
Danish: Slagtning: 13 døgn.
English: Withdrawal period(s)
Danish: TILBAGEHOLDELSESTID(er)
English: STATEMENT OF ACTIVE SUBSTANCES Active substance:
Danish: ANGIVELSE AF AKTIVE STOFFER Aktivt stof:
English: PSUR submission for Kriptazen shall be synchronised and submitted at the same frequency as for the reference product, Halocur.
Danish: Den periodiske, opdaterede sikkerhedsindberetninger (PSUR) cyklus for Kriptazen bør følge samme frekvens som reference præparatet, Halocur.
English: - Reduction of diarrhoea due to diagnosed Cryptosporidium parvum.
Danish: - Reduktion af diarré forårsaget af diagnosticeret Cryptosporidium parvum-infektion.
English: Luxembourg/Luxemburg VIRBAC BELGIUM NV Esperantolaan 4
Danish: VIRBAC BELGIUM NV Esperantolaan 4
English: 6) Restrain the calf and insert the nozzle of the metering pump into its mouth.
Danish: 6) Hold kalven og placer pumpens mundstykke i dens mund.
English: In cases where the dosing pump is unsuitable for the weight of animals to be treated, either a syringe or any other appropriate device can be used.
Danish: I de tilfælde, hvor doseringspumpen ikke passer med vægten af dyrene, som skal behandles, kan en sprøjte eller andet passende udstyr bruges.
English: DATE OF FIRST AUTHORISATION/ RENEWAL OF THE AUTHORISATION Date of first authorisation: 08/02/2019
Danish: DATO FOR FØRSTE TILLADELSE/FORNYELSE AF TILLADELSEN
English: Benzoic acid (E 210)
Danish: Benzoesyre (E210)
English: Use during pregnancy, lactation or lay
Danish: 4.7 Anvendelse under drægtighed, laktation eller æglægning
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Kriptazen 0.5 mg/ml oral solution for calves halofuginone
Danish: Kriptazen 0,5 mg/ml, oral opløsning til kalve halufuginon
English: Cardboard box with a 500 ml bottle containing 490 ml or a 1000 ml bottle containing 980 ml, with or without a dosing pump.
Danish: Papæske indeholdende en 500 ml flaske med 490 ml eller en 1.000 ml flaske med 980 ml med eller uden doseringspumpe.
English: 7) Pull the trigger of the metering pump completely for release of the adequate dose.
Danish: 7) Træk pumpens aftrækker helt tilbage for at afgive hele den valgte dosis.
English: Cardboard box containing one 500 ml bottle (high-density polyethylene) containing 490 ml of solution or one 1000 ml bottle containing 980 ml of solution, sealed with a high density polyethylene cap, with or without a metering pump, with two different lengths dip tubes (22 and 24 cm) made of ethylenevinyl acetate.
Danish: Papæske indeholdende en 500 ml flaske (polyetylen af høj densitet) med 490 ml oral opløsning eller en 1.000 ml flaske med 980 ml oral opløsning, lukket med en hætte af polyetylen af høj densitet, med eller uden doseringspumpe med sugerør (22 og 24 cm) af etylenvinylacetat.
English: WITHDRAWAL PERIOD(S) Meat and offal: 13 days.
Danish: Tilbageholdelsestid(er): Slagtning: 13 døgn.
English: Medicines Agency http://www.ema.europa.eu/.
Danish: Yderligere information om dette lægemiddel er tilgængelig på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu
English: Carton with bottle and dosing device
Danish: Æske med flaske med doseringspumpe
English: - Avoid skin, eye or mucosal contact with the product.
Danish: - Undgå at præparatet kommer i kontakt med hud, øjne og slimhinder.
English: A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE Name and address of the manufacturer responsible for batch release VIRBAC
Danish: Navn og adresse på fremstilleren ansvarlig for batchfrigivelse VIRBAC
English: Package without a metering pump:
Danish: Pakninger uden doseringspumpe:
English: 1) Choose the dip tube designed for the height of the bottle (the shorter one for the 490 ml bottle and the longer one for the 980 ml) and insert it into the free hole located in the base of the pump cap. 2) Remove the cap of the bottle and screw the pump on.
Danish: 1) Vælg det sugerør der passer til højden af flasken (den korte til 490 ml flasken og den lange til 980 ml) og indsæt det i det ledige hul på undersiden af pumpens hætte.
English: Pu l awska 314 PL-02 819 Warszawa Tel.: + 48 22 855 40 46
Danish: PL-02 819 Warszawa Tel.: + 48 22 855 40 46
English: PHARMACEUTICAL FORM Oral solution.
Danish: Oral opløsning.
English: Each package also contains a plastic metering pump delivering 4 to 12 ml and two dip tubes (one to fit a 500 ml bottle and one to fit a 1000 ml bottle).
Danish: Hver pakning indeholder en 4 til 12 ml doseringspumpe og to sugerør (en der passer til 500 ml flaske og en der passer til 1.000 ml flasken).
English: Suomi/Finland VIRBAC
Danish: Suomi/Finland
English: 10) Always replace the bottle in the box.
Danish: 10) Sæt altid flasken tilbage i yderemballagen.
English: [Bottle with a 4 to 12 ml pump:] To ensure a correct dosage, the most appropriate metering pump should be selected, depending on the weight of the animals to be treated.
Danish: [Flaske med en 4 til 12 ml pumpe:] For at sikre en korrekt dosering, bør den doseringspumpe vælges som passer bedst til vægten af de dyr, som skal behandles.
English: Special precautions for the disposal of unused veterinary medicinal products or waste materials derived from the use of such products
Danish: 6.6 Eventuelle særlige forholdsregler ved bortskaffelse af ubrugte veterinærlægemidler eller affaldsmaterialer fra brugen af sådanne
English: Halofuginone (as lactate salt)
Danish: halofuginon (som laktatsalt)
English: Major Incompatibilities
Danish: 6.2 Væsentlige uforligeligheder
English: 5) Prime the pump by pressing the trigger gently, until a drop appears at the tip of the nozzle.
Danish: 5) Fyld pumpen op ved forsigtigt at presse på aftrækkeren indtil en dråbe bliver synlig på mundstykkets spids.
English: 9) Always replace the bottle in the box.
Danish: 9) Sæt altid flasken tilbage i yderemballagen.
English: Each package also contains a plastic metering pump delivering 4 ml volumes and two dip tubes (one to fit a 500 ml bottle and one to fit a 1000 ml bottle).
Danish: Hver pakning indeholder en 4 ml doseringspumpe og to sugerør (en der passer til 500 ml flaske og en der passer til 1.000 ml flasken).
English: Pull two or three times, respectively, for administration of the desired volume (8 ml for calves weighing more than 35 kg but less than or equal to 45 kg and 12 ml for calves weighing more than 45 kg but less than or equal to 60 kg).
Danish: Gentag evt. to eller tre gange for at give det nødvendige volumen (8 ml til kalve, der vejer fra 35-45 kg og 12 ml til kalve der vejer 46-60 kg).
English: 4) Prime the pump by pressing the trigger gently, until a drop appears at the tip of the nozzle.
Danish: 4) Fyld pumpen op ved forsigtigt at presse på aftrækkeren indtil en dråbe bliver synlig på mundstykkets spids.
English: For treatment of anorexic calves, the product should be administered in half a litre of an electrolyte solution.
Danish: Hos kalve,hvor ædelyst er ophørt, bør præparatet indgives sammen med en halv liter elektrolytopløsning.
English: PACKAGE LEAFLET: Kriptazen 0.5 mg/ml oral solution for calves NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT Marketing authorisation holder and manufacturer responsible for batch release: VIRBAC 1ère avenue - 2065 m - LID 06516 Carros France
Danish: Kriptazen 0,5 mg/ml, oral opløsning til kalve NAVN OG ADRESSE PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN SAMT PÅ DEN INDEHAVER AF VIRKSOMHEDSGODKENDELSE, SOM ER ANSVARLIG FOR BATCHFRIGIVELSE, HVIS FORSKELLIG HERFRA
English: Cattle (new born calves): - Prevention of diarrhoea due to diagnosed Cryptosporidium parvum, in farms with history of
Danish: Hos nyfødte kalve: - Forebyggelse af diarré forårsaget af diagnosticeret Cryptosporidium parvum-infektion i
English: [Bottle without a pump:] To ensure a correct dosage, the use of either a syringe or any appropriate device for oral administration is necessary.
Danish: [Flaske uden pumpe:] For at sikre en korrekt dosering via munden er det nødvendigt at bruge enten en sprøjte eller en anden form for egnet udstyr.
English: DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION For oral use in calves after feeding.
Danish: DOSERING FOR HVER DYREART, ANVENDELSESMÅDE OG INDGIVELSESVEJ(E)
English: Boxes with a metering pump:
Danish: Æsker med doseringspumpe:
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Kriptazen 0.5 mg/ml oral solution for calves.
Danish: Kriptazen 0,5 mg/ml, oral opløsning til kalve.
English: Bottle without a pump: To ensure a correct dosage, the use of either a syringe or any appropriate device for oral administration is necessary.
Danish: Flaske uden pumpe: For at sikre en korrekt dosering via munden er det nødvendigt at bruge enten en sprøjte eller en anden form for egnet udstyr.
English: Bottle with a pump: To ensure a correct dosage, the most appropriate metering pump should be selected, depending on the weight of the animals to be treated.
Danish: Flaske med pumpe: For at sikre en korrekt dosering skal den pumpe, der passer bedst til dyrets vægt, bruges.
English: Pharmacodynamic properties
Danish: 5.1 Farmakodynamiske egenskaber
English: Package with a metering pump:
Danish: Pakninger med doseringspumpe:
English: Administer after colostrum feeding, or after milk or milk replacer feeding only, using an appropriate device for oral administration.
Danish: Må kun indgives efter fodring med kolostrum, mælk eller mælkeerstatning.
English: To ensure a correct dosage, the use of either a syringe or any appropriate device for oral administration is necessary.
Danish: For at sikre en korrekt dosering via munden er det nødvendigt at bruge enten en sprøjte eller en anden form for egnet udstyr.
English: 9) Always replace the cap on the tip of the nozzle after use.
Danish: 9) Sæt altid beskyttelseshætten på mundstykkets spids efter brug.
English: 8) Always replace the cap on the tip of the nozzle after use.
Danish: 8) Sæt altid beskyttelseshætten på mundstykkets spids efter brug.
English: [Bottle with a 4 ml pump:] To ensure a correct dosage, the most appropriate metering pump should be selected, depending on the weight of the animals to be treated.
Danish: [Flaske med en 4 ml pumpe:] For at sikre en korrekt dosering skal den pumpe, der passer bedst til dyrets vægt, bruges.
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER VIRBAC
Danish: NAVN OG ADRESSE PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN
English: Pharmacokinetic particulars
Danish: 5.2 Farmakokinetiske oplysninger
English: MARKETING AUTHORISATION HOLDER VIRBAC
Danish: Indehaver af markedsføringstilladelsen og fremstiller ansvarlig for batchfrigivelse: VIRBAC
English: 5) Restrain the calf and insert the nozzle of the metering pump into its mouth 6) Pull the trigger of the metering pump completely for release of a dose that equals 4 ml of solution.
Danish: 6) Træk pumpens aftrækker helt tilbage for at afgive en dosis på 4 ml opløsning.
English: In new born calves: - Prevention of diarrhoea due to diagnosed Cryptosporidium parvum, in farms with history of cryptosporidiosis.
Danish: Hos nyfødte kalve: - Forebyggelse af diarré forårsaget af diagnosticeret Cryptosporidium parvum-infektion i Behandlingen skal starte inden for 24 til 48 timer efter fødslen.
English: Indications for use, specifying the target species
Danish: 4.2 Terapeutiske indikationer med angivelse af dyrearter, som lægemidlet er beregnet til
English: Incompatibilities
Danish: Uforligeligheder:
English: Contraindications
Danish: INDIKATIONER
English: METHOD AND ROUTE(S) OF ADMINISTRATION For oral use.
Danish: ANVENDELSESMÅDE OG INDGIVELSESVEJ(E)
English: Disposal : read package leaflet.
Danish: Alle hjælpestoffer er anført under pkt.
English: Pharmacologically active substance
Danish: ANGIVELSE AF AKTIVE STOFFER
English: EU/1/15/1024/001 Keytruda 50 mg Powder for concentrate for solution for infusion
Danish: EU/1/15/1024/001 Keytruda 50 mg
English: The exact cause is not known.
Danish: Den præcise årsag er ukendt.
English: The updated data should be submitted by 31st December
Danish: De opdaterede data skal indsendes senest 31. december 2015
English: Baseline characteristics were generally balanced between the two groups.
Danish: Baseline-karakteristika var generelt afbalancerede mellem de to grupper.
English: The estimated 1-year survival rate was 41%.
Danish: Den estimerede overlevelsesrate efter 1 år var 41%.
English: The PFS was measured by RECIST version 1.1.
Danish: PFS blev målt ved RECIST version 1.1.
English: You will also have blood tests during your treatment.
Danish: Du vil også få taget blodprøver i løbet af behandlingen.
English: denotes a censored observation.
Danish: betegner en censureret observation.
English: Please note that these signs and symptoms are sometimes delayed, and may develop weeks or months after your last dose.
Danish: Du skal være opmærksom på, at disse tegn og symptomer nogle gange er forsinkede og kan opstå uger eller måneder efter din sidste dosis.
English: ATC code: L01XC17.
Danish: ATC-kode: L01XC17.
English: Preparation and administration
Danish: Tilberedning og administration
English: Probability of Survival
Danish: Sandsynlighed for overlevelse Sandsynlighed for overlevelse
English: Before treatment, your doctor will check your general health.
Danish: Inden behandlingen vil lægen undersøge din almene helbredstilstand.
English: However, the role of this biomarker (PD-L1 expression) has not been fully elucidated.
Danish: Imidlertid er denne biomarkørs (PD-L1-ekpression) rolle ikke fuldt belyst.
English: Because many medicinal products, including antibodies, can be secreted in human milk, a risk to the newborns/infants cannot be excluded.
Danish: Eftersom mange lægemidler, herunder antistoffer, kan udskilles i human mælk, kan en risiko for den nyfødte/spædbarnet ikke udelukkes.
English: Patients were enrolled regardless of their PD-L1 status.
Danish: Patienterne blev optaget i studiet uanset deres PD-L1-status.
English: Very common (may affect more than 1 in 10 people) Decreased appetite
Danish: Meget almindelig (kan forekomme hos flere end 1 ud af 10 personer) Nedsat appetit
English: Appendix V.
Danish: Appendiks V.
English: Treatment modification
Danish: Behandlingsændring
English: Your doctor may give you other medicines in order to prevent complications and reduce your symptoms,
Danish: Din læge vil give dig anden medicin for at forebygge komplikationer og mildne dine symptomer,
English: From a microbiological point of view, the product should be used immediately.
Danish: Ud fra en mikrobiologisk betragtning bør lægemidlet anvendes straks.
English: These reactions are presented by system organ class and by frequency.
Danish: Disse bivirkninger er anført efter systemorganklasse og hyppighed.
English: The observed OS benefit was consistently demonstrated across subgroups of patients.
Danish: Den observerede OS-fordel blev vist konsistent på tværs af forskellige undergrupper af patienter.
English: Tumour assessments, according to the Response Evaluation Criteria in Solid Tumours (RECIST), version 1.1, were conducted 9 weeks after randomisation and continued every 6 weeks thereafter.
Danish: Tumorvurdering ifølge Response Evaluation Criteria in Solid Tumours (RECIST), version 1.1, blev udført 9 uger efter randomisering og fortsatte hver 6. uge herefter.
English: Because of the small sample size, no definitive conclusions can be drawn from these data.
Danish: På grund af den lille populationsstørrelse kan der ikke drages nogen endelige konklusioner på baggrund af disse data.
English: There are no data on the use of nivolumab in pregnant women.
Danish: Der foreligger ingen data fra anvendelse af nivolumab til gravide kvinder.
English: The Kaplan-Meier curves for OS are shown in Figure 1.
Danish: Kaplan-Meier kurverne over OS er vist i figur 1.
English: You will receive treatment with Nivolumab BMS in a hospital or clinic, under the supervision of an experienced doctor.
Danish: Du vil få Nivolumab BMS på et hospital eller en klinik under opsyn af en erfaren læge.
English: Frequencies reflect the proportion of patients who experienced a worsening from baseline in laboratory measurements.
Danish: Hyppighederne afspejler den andel af patienter, som i laboratoriemålinger oplevede forværring i forhold til baseline.
English: Nivolumab CL increased with increasing body weight.
Danish: Nivolumab CL steg i takt med stigende kropsvægt.
English: Do not take any other medicines during your treatment without talking to your doctor first.
Danish: Du må ikke tage anden medicin under behandlingen uden først at tale med lægen.
English: No overall differences in safety or efficacy were reported between elderly ( ≥ 65 years) and younger patients (< 65 years).
Danish: Der blev ikke rapporteret nogen generelle forskelle i sikkerhed og virkning mellem ældre (≥ 65 år) og yngre patienter (< 65 år).
English: Nivolumab BMS may cause changes in the results of tests carried out by your doctor.
Danish: Nivolumab BMS kan medføre ændringer i resultaterne af de prøver, som lægen tager.
English: You will also find this information in the Patient Alert Card you have been given by your doctor.
Danish: Disse oplysninger står også i det patient-informationskort, som du har fået af din læge.
English: The following side effects have been reported in clinical trials with nivolumab:
Danish: Følgende bivirkninger er blevet rapporteret i kliniske forsøg med nivolumab:
English: Guidelines for permanent discontinuation or withholding of doses are described in Table 1.
Danish: Retningslinjer for permanent seponering eller udsættelse af doser fremgår af tabel 1.