FrancophonIA/ELRC3.0 huggingface dataset:
English: Keep this medicine out of the sight and reach of children.
Danish: Opbevaring Opbevar lægemidlet utilgængeligt for børn.
English: d p-value from the Cochran-Mantel-Haenszel chi-square test adjusted for the stratification factors; analysis by line of therapy excludes stratification for therapeutic history * CR+PR+MR **CR=CR, (IF-); nCR=CR (IF+) NA=not applicable, NE=not estimated TTP-Time to Progression
Danish: d p-værdi fra Cochran-Mantel-Haenszel chi-square-testen justeret for stratifikationsfaktorer; analyse ud fra behandling udelukker opdeling på tidligere behandling.
English: Uncommon Fall, Contusion Rare
Danish: Sjælden Død (inkl.
English: Patients in the BzmbR-CAP treatment arm received bortezomib (1.3 mg/m2; on days 1, 4, 8, 11, rest period days 12-21), rituximab 375 mg/m2 IV on day 1; cyclophosphamide 750 mg/m2 IV on day 1; doxorubicin 50 mg/m2 IV on day 1; and prednisone 100 mg/m2 orally on day 1 through day 5 of the 21 day bortezomib treatment cycle.
Danish: Patienterne i BzmbR-CAP-armen fik bortezomib (1,3 mg/m2 på dag 1, 4, 8, 11, hvileperiode på dag 12-21), rituximab 375 mg/m2 i.v.
English: How Bortezomib SUN is given
Danish: Sådan bruges Bortezomib SUN
English: Common Oedema (inc peripheral), Chills, Injection site reaction*, Malaise*
Danish: perifert), kuldegysninger, reaktion på injektionsstedet*, utilpashed*
English: Day Day
Danish: Dag Dag
English: Nervous system disorders Very Common
Danish: Det endokrine system Ikke almindelig
English: or
Danish: Øjne
English: sometimes associated with pain or bleeding, poor movement of the intestines (including blockage), abdominal or oesophageal discomfort, difficulty swallowing, vomiting of blood - skin infections - bacterial and viral infections - tooth infection - inflammation of the pancreas, obstruction of the bile duct - genital pain, problem having an erection - weight increase - thirst - hepatitis - injection site or injection device related disorders - skin reactions and disorders (which may be severe and life threatening), skin ulcers - bruises, falls and injuries - inflammation or haemorrhage of the blood vessels that can appear as small red or purple dots
Danish: blødning fra øjnene - hævede lymfekirtler - stivhed i led og muskler, følelse af tunghed, smerter i skridtet - hårtab og unormal hårstruktur - allergiske reaktioner - rødmen eller smerte på injektionsstedet - smerter i munden - infektioner eller betændelse i munden, sår i mund, spiserør, mave og tarm, somme tider forbundet med smerter eller blødning, nedsat tarmbevægelse (herunder blokering), ubehag i maveregionen eller spiserøret, synkebesvær, opkastning af blod - hudinfektioner - bakterie- og virusinfektioner - tandinfektion - betændelse i bugspytkirtlen, tilstopning af galdegangen - smerter i kønsorganerne, problemer med rejsning af penis - vægtøgning - tørst - leverbetændelse - forstyrrelser forbundet med injektionsstedet eller -udstyret - hudreaktioner og hudsygdomme (som kan være alvorlige og livstruende), hudsår
English: Common Hypotension*, Orthostatic hypotension, Hypertension* Uncommon Cerebrovascular accident#, Deep vein thrombosis*, Haemorrhage*, Thrombophlebitis (inc superficial), Circulatory collapse (inc hypovolaemic shock), Phlebitis, Flushing*, Haematoma (inc perirenal)*, Poor peripheral circulation*, Vasculitis, Hyperaemia (inc ocular)*
Danish: Pancytopeni*, febril neutropeni, koagulopati*, leukocytose*, lymfadenopati, hæmolytisk anæmi# Sjælden Dissemineret intravaskulær koagulation, trombocytose*, hyperviskositetssyndrom, uspecificeret påvirkning af trombocytfunktionen, trombotisk mikroangiopati (herunder trombocytopenisk purpura)#, uspecificeret blodsygdom, hæmoragisk diatese, lymfocytinfiltration
English: (check that the syringe is marked as subcutaneous administration).
Danish: - Tjek dosis og koncentration i sprøjten før brug (kontroller, at sprøjten er mærket som subkutan administration).
English: Breast-feeding
Danish: Pancytopeni*
English: Common Vision abnormal*
Danish: Almindelig Abnorme leverenzymer* Ikke almindelig
English: Aplasia, Gastrointestinal malformation, Ichthyosis
Danish: Sjælden Aplasi, misdannelse i mave-tarm-kanalen, iktyose
English: Bortezomib subcutaneous arm
Danish: Bortezomib subkutan gruppe
English: Atrial flutter, Myocardial infarction*, Atrioventricular
Danish: venstre og højre ventrikel)*, myokardieiskæmi, ventrikeldysfunktion*
English: Rest period
Danish: Pause
English: At least 72 hours should elapse between consecutive doses of Bortezomib SUN. Dexamethasone is administered orally at 20 mg on days 1, 2, 4, 5, 8, 9, 11, and 12 of the Bortezomib SUN treatment cycle.
Danish: - Når Bortezomib SUN gives sammen med dexamethason, får du Bortezomib SUN intravenøst eller subkutant i en 21-dages behandlingscyklus, og dexamethason 20 mg gives gennem munden på dag 1, 2, 4, 5, 8, 9, 11 og 12 i den 21-dages behandlingscyklus med Bortezomib SUN.
English: Tabulated summary of adverse reactions
Danish: Oversigt over bivirkningerne i tabelform
English: Thalidomide is given orally daily at 50 mg up to day 14 of the first cycle, and if tolerated the thalidomide dose is increased to 100 mg on days 15-28 and may be further increased to 200 mg daily from the second cycle onwards.
Danish: Dexamethason gives i en dosis på 40 mg gennem munden på dag 1, 2, 3, 4, 8, 9, 10 og 11 i hver 28-dages behandlingscyklus med Bortezomib SUN, og thalidomid gives dagligt gennem munden i en dosis på 50 mg frem til dag 14 i den første cyklus, og hvis du tolererer thalidomiddosen, øges den til 100 mg på dag 15-28 og kan derefter øges igen til 200 mg dagligt fra og med den anden cyklus.
English: Musculoskeletal and connective tissue disorders
Danish: Muskuloskeletale smerter*
English: > 1 prior line of therapy
Danish: > 1 tidligere behandling tidligere behandli nger
English: SGOT (AST) levels Modification of starting dose
Danish: Justering af initialdosis
English: Musculoskeletal pain* Common Muscle spasms*, Pain in extremity, Muscular weakness Uncommon Muscle twitching, Joint swelling, Arthritis*, Joint stiffness, Myopathies*,Sensation of heaviness
Danish: Muskeltrækninger, hævede led, artritis*, stive led, myopatier*, fornemmelse af tyngde Sjælden Rabdomyolyse, kæbeledssyndrom, fistel, ledeffusion, kæbesmerter, knoglesygdom, infektioner og inflammationer i knogler, led og bindevæv*, synovialcyste
English: Uncommon Pancreatitis (inc chronic)*, Haematemesis, Lip swelling*, Gastrointestinal obstruction (inc small intestinal obstruction, ileus)*, Abdominal discomfort, Oral ulceration*, Enteritis*, Gastritis*, Gingival bleeding, Gastrooesophageal reflux disease*, Colitis (inc clostridium difficile)*, Colitis ischaemic#, Gastrointestinal inflammation*, Dysphagia, Irritable bowel syndrome, Gastrointestinal disorder NOS, Tongue coated, Gastrointestinal motility disorder*, Salivary gland disorder*
Danish: tyndtarmsobstruktion, ileus)*, abdominalt ubehag, mundsår*, enteritis*, gastritis*, gingival blødning, gastroøsofageal reflukssygdom*, colitis (inkl.
English: Uncommon Cardiac tamponade#, Cardio-pulmonary arrest*, Cardiac fibrillation (inc atrial), Cardiac failure (inc left and right ventricular)*, Arrhythmia*, Tachycardia*, Palpitations, Angina pectoris, Pericarditis (inc pericardial effusion)*, Cardiomyopathy*, Ventricular dysfunction*, Bradycardia
Danish: venstre og højre ventrikel)*, arytmi*, takykardi*, palpitationer, angina pectoris, perikarditis (inkl.
English: Class
Danish: ASAT
English: Progression Free Survival, months
Danish: Progressionsfri overlevelse, måneder (95 % CI)
English: and Citovirax.
Danish: og Citovirax.
English: The European Commission issued an EU-wide legally binding decision on this opinion on 28 April 2016.
Danish: Europa-Kommissionen traf en juridisk bindende afgørelse med gyldighed i hele EU på grundlag af denne udtalelse den 28 april 2016.
English: Cymevene is marketed in all EU member states with the exception of Latvia, Malta and Slovenia.
Danish: Cymevene markedsføres i alle EU's medlemsstater, bortset fra Letland, Malta og Slovenien.
English: Cymevene has been authorised in the EU via national procedures.
Danish: Cymevene blev godkendt i EU via nationale procedurer.
English: The company that markets these medicines is F. Hoffmann - La Roche Ltd. and associated companies.
Danish: Disse lægemidler markedsføres af F. Hoffmann - La Roche Ltd. og associerede selskaber.
English: What is Cymevene?
Danish: Hvad er Cymevene?
English: It is also available in the EU under the names Cymevan, Cymeven i.v.
Danish: Det fås også i EU under navnene Cymevan, Cymeven i.v.
English: Ganciclovir has the potential to cause birth defects in humans.
Danish: Ganciclovir kan potentielt forårsage fødselsdefekter hos mennesker.
English: Why was Cymevene reviewed?
Danish: Hvorfor blev Cymevene vurderet igen?
English: The Committee also harmonised other sections of the SmPC including sections 4.4 (special warnings and precautions for use), 4.5 (interactions) and 4.8 (side effects).
Danish: CHMP harmoniserede også andre afsnit af produktresuméet, herunder afsnit 4.4 (særlige advarsler og forsigtighedsregler vedrørende brugen), 4.5 (interaktioner) og 4.8 (bivirkninger).
English: Patients with reduced kidney function should receive lower doses of Cymevene.
Danish: Patienter med nedsat nyrefunktion bør have lavere doser af Cymevene.
English: Information on the safety and efficacy of Cymevene in children under 12 years of age is limited.
Danish: Oplysningerne om Cymevenes sikkerhed og virkning hos børn under 12 år er begrænsede.
English: CMV is a common virus that belongs to the herpes virus family.
Danish: CMV er et almindeligt virus, der tilhører herpes-familien.
English: On 25 February 2016, the European Medicines Agency completed a review of Cymevene.
Danish: Den 25. februar 2016 afsluttede Det Europæiske Lægemiddelagentur en gennemgang af Cymevene.
English: Different treatment schedules should be followed during initial and maintenance treatment, in accordance with treatment guidelines.
Danish: Der skal benyttes forskellige behandlingsplaner ved den indledende og den efterfølgende vedligeholdelsesbehandling, jf. behandlingsretningslinjerne.
English: The medicine can be used in adults and adolescents from 12 years of age.
Danish: Cymevene kan anvendes til voksne og unge fra 12 år.
English: The recommended dose of Cymevene and duration of treatment depend on the weight of the patient and on whether the medicine is used to prevent or treat CMV disease.
Danish: Den anbefalede dosis af Cymevene og behandlingsvarighed afhænger af patientens vægt og af, om lægemidlet anvendes til at forebygge eller behandle CMV-sygdomme.
English: The CHMP was unable to make recommendations on such use based on currently available data and further assessment should be carried out.
Danish: CHMP har ikke kunnet fremsætte anbefalinger vedrørende brug til børn under 12 år på baggrund af de foreliggende data; der bør foretages yderligere vurderinger.
English: Questions and answers on Cymevene and associated names (ganciclovir, 500 mg powder for concentrate for solution for infusion, intravenous)
Danish: Spørgsmål og svar vedrørende Cymevene og relaterede navne (ganciclovir, 500 mg pulver til koncentrat til intravenøs infusionsvæske, opløsning)
English: This has led to divergences across member states in the way the medicine can be used, as seen in the differences in the summaries of product characteristics (SmPCs), labelling and package leaflets in the countries where the medicine is marketed.
Danish: Dette har medført afvigelser i lægemidlets anvendelsesmåde i medlemsstaterne, hvilket fremgår af forskellene i produktresuméerne, etiketteringen og indlægssedlerne i de lande, hvor lægemidlet markedsføres.
English: In these patients, CMV can result in severe or life-threatening infections that attack various organs including the lungs, brain and eyes.
Danish: Hos disse patienter kan CMV give alvorlige eller livstruende infektioner i organer som f.eks. lunger, hjerne og øjne.
English: For this reason, the CHMP agreed that Cymevene should not be used in pregnant women unless the potential benefit to the mother outweighs the potential risk to the unborn child.
Danish: Derfor vurderer CHMP, at Cymevene ikke bør anvendes til gravide kvinder, medmindre de mulige fordele for moderen opvejer eventuelle risici for det ufødte barn.
English: It can infect almost anyone but usually remains dormant in healthy people, rarely causing symptoms.
Danish: Stort set alle kan blive smittet med det, men hos raske personer er det normalt latent og giver sjældent symptomer.
English: Since the use of highly active antiretroviral therapy (HAART) has reduced the risk of CMV disease in patients with HIV infection, preventive treatment with Cymevene is no longer considered necessary.
Danish: Da brugen af højaktiv antiretroviral terapi (HAART) har reduceret risikoen for CMV-sygdomme hos patienter med hiv-infektion, vurderes forebyggende behandling med Cymevene ikke længere at være nødvendigt.
English: It is not known whether ganciclovir passes into breast milk; however this possibility cannot be excluded and therefore breastfeeding must be discontinued in women treated with Cymevene, to avoid potential serious side effects in breastfed infants.
Danish: Det vides ikke, om ganciclovir udskilles i modermælken; dette kan dog ikke udelukkes, og derfor skal kvinder, der behandles med Cymevene, holde op med at amme for at undgå eventuelle alvorlige bivirkninger hos det diende barn.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that there is a need to harmonise the prescribing information for Cymevene in the European Union (EU).
Danish: Agenturets Udvalg for Lægemidler til Mennesker (CHMP) konkluderede, at der er behov for at harmonisere ordineringsoplysningerne for Cymevene i Den Europæiske Union (EU).
English: On 15 September 2014, the European Commission referred the matter to the CHMP in order to harmonise the marketing authorisations for Cymevene in the EU.
Danish: Den 15. september 2014 indbragte Europa-Kommissionen sagen for CHMP med henblik på at harmonisere markedsføringstilladelserne for Cymevene i EU.
English: When prescribing Cymevene, consideration should be given to official guidance on the appropriate use of antiviral agents.
Danish: Ved ordinering af Cymevene skal de officielle retningslinjer vedrørende korrekt brug af antivirale midler følges.
English: Having harmonised the indication, the CHMP also harmonised the recommendations on how to use Cymevene.
Danish: Foruden indikationerne harmoniserede CHMP også anbefalingerne for brug af Cymevene.
English: Women who could become pregnant must be advised to use effective contraception during treatment with Cymevene and for at least 30 days after treatment has stopped.
Danish: Kvinder, der kan blive gravide, skal informeres om, at de skal bruge effektiv prævention under behandlingen med Cymevene og i mindst 30 dage efter behandlingens ophør.
English: The CHMP also agreed that Cymevene should no longer be indicated for the prevention of CMV disease in patients with AIDS.
Danish: CHMP vurderede også, at Cymevene ikke længere bør være indiceret til at forebygge CMV-sygdomme hos patienter med aids.
English: Cymevene must not be used in patients allergic to its active substance ganciclovir, to a related antiviral medicine, valganciclovir, or to any other ingredients of the medicine.
Danish: Cymevene må ikke anvendes til patienter, der er allergiske over for det aktive stof ganciclovir, et relateret antiviralt lægemiddel, valganciclovir eller et eller flere af de øvrige indholdsstoffer.
English: Cymevene can also be used to prevent CMV disease in patients with drug-induced immunosuppression (for example after an organ transplant or chemotherapy).
Danish: Cymevene kan også anvendes til at forebygge CMV-sygdomme hos patienter med lægemiddelinduceret nedsat immunforsvar (f.eks. efter organtransplantation eller kemoterapi).
English: However, the virus can cause problems in people with a weakened immune system such as people with acquired immune deficiency syndrome (AIDS) or who are undergoing cancer treatment or taking medicines to prevent rejection of an organ transplant.
Danish: Virusset kan imidlertid give problemer hos personer med nedsat immunforsvar, f.eks. personer med aids (erhvervet immundefektsyndrom) eller personer, der får kræftbehandling eller medicin mod afstødning af et transplanteret organ.
English: Men whose female partner could become pregnant must be advised to use barrier contraception methods during treatment with Cymevene, and for at least 90 days afterwards.
Danish: Mænd, hvis kvindelige partner kan blive gravid, skal informeres om, at de skal bruge en barrieremetode under behandlingen med Cymevene og i mindst 90 dage efter behandlingens ophør.
English: The CHMP, in the light of the data submitted and the scientific discussion within the Committee, was of the opinion that the SmPCs, labelling and package leaflets should be harmonised across the EU.
Danish: På baggrund af de forelagte oplysninger og den videnskabelige drøftelse i udvalget fandt CHMP det nødvendigt at harmonisere produktresuméerne, etiketteringen og indlægssedlerne i EU.
English: Cymevene contains the active substance ganciclovir and is available as a powder to be made into a solution for infusion (drip) into a vein.
Danish: Cymevene indeholder det aktive stof ganciclovir og leveres som et pulver, der blandes til en infusionsvæske, opløsning, (drop) til indgift i en vene.
English: The CHMP agreed that Cymevene can be used for the treatment of diseases caused by CMV in immunocompromised patients.
Danish: CHMP vurderede, at Cymevene kan anvendes til behandling af sygdomme forårsaget af CMV hos patienter med nedsat immunforsvar.
English: Cymevene is an antiviral medicine that is used to treat or prevent infection with cytomegalovirus (CMV) in immunocompromised individuals (people with a weakened immune system).
Danish: Cymevene er at antiviralt lægemiddel, der anvendes til behandling eller forebyggelse af cytomegalovirus (CMV)-infektion hos personer med nedsat immunforsvar.
English: Cymevene was identified as needing harmonisation by the Co-ordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh).
Danish: CMDh (koordinationsgruppen vedrørende gensidig anerkendelse og decentral procedure - lægemidler til mennesker) fandt det nødvendigt at harmonisere Cymevene.
English: The following doses and administration methods should be used:
Danish: Følgende doser og administrationsmetoder bør anvendes:
English: ATCvet code: QI02AD04.
Danish: ATCvet-kode: lQI02AD04.
English: It is recommended to use a new applicator for each animal.
Danish: Det anbefales at bruge en ny applikator til hvert dyr.
English: Volume of solvent to be used
Danish: Volumen af solvens, der skal bruges
English: <{DD/MM/YYYY}>
Danish: {DD / MM / ÅÅÅÅ}
English: Date of first authorisation: 29/07/2019
Danish: Dato for første markedsføringstilladelse: 29/07/2019
English: Avoid contamination during reconstitution and use.
Danish: Undgå kontaminering under rekonstitution og brug.
English: Reconstitute the vaccine with the corresponding volume of solvent:
Danish: Rekonstituér vaccinen med den passende mængde solvens:
English: The 5 doses vial is now ready to use.
Danish: Hætteglasset med de 5 doser er nu klar til brug.
English: Solvent: Store below 25 °C.
Danish: Solvens: Opbevares under 25°C.
English: Cattle from 9 days of age:
Danish: Kvæg, fra de er 9 dage gamle:
English: Solvent for NASYM
Danish: Solvens til NASYM
English: EXP {month/year}
Danish: EXP. {måneder/år}
English: Reduction of respiratory clinical signs (but not a reduction of virus shedding) is observed 5 days after nasal vaccination.
Danish: Reduktion af respiratoriske kliniske symptomer (men ikke reduktion af virusspredning) er set 5 dage efter nasal vaccination.
English: Cattle from 10 weeks of age:
Danish: Kvæg, fra de er 10 uger gamle:
English: Do not use this veterinary medicinal product and the solvent after the expiry date which is stated on the carton and the label.
Danish: Brug ikke dette veterinærlægemiddel eller solvensen efter den udløbsdato, der står på æsken og etiketten.
English: Solvent: Homogeneous-clear solution.
Danish: Solvens: Homogen, klar opløsning.
English: Shelf life of the veterinary medicinal product as packaged for sale: 15 months.
Danish: Opbevaringstid for veterinærlægemidlet i salgspakning: 15 måneder.
English: *Cell culture infectious dose 50%
Danish: *Infektionsdosis i cellekultur 50 %
English: 6 months after intramuscular vaccination.
Danish: 6 måneder efter intramuskulær vaccination.
English: The reconstituted vaccine is a slightly yellowish homogeneous suspension.
Danish: Den rekonstituerede vaccine er en let gullig, homogen suspension.
English: Full immunity is established from 21 days after nasal vaccination.
Danish: Fuld immunitet er etableret 21 dage efter nasal vaccination.
English: Duration of immunity: 2 months after nasal vaccination.
Danish: Varighed af immunitet: 2 måneder efter nasal vaccination.
English: NZ amine
Danish: NZ-amin
English: One dose is 2 ml.
Danish: En dosis er 2 ml.
English: Special precautions for use in animals: Vaccinate healthy animals only.
Danish: Særlige forsigtighedsregler vedrørende brugen: Kun raske dyr må vaccineres.
English: The excipients listed in section 6.1 of the SPC are allowed substances for which table 1 of the annex to Commission Regulation (EU) No 37/2010 indicates that no MRLs are required or considered as not falling within the scope of Regulation (EC) No 470/2009 when used as in this veterinary medicinal product.
Danish: Hjælpestofferne (inklusive adjuvanter) som er anført i punkt 6.1 af SPC'et er enten tilladte hjælpestoffer, hvor tabel 1 i bilaget til Kommissionens forordning (EU) Nr. 37/2010 indikerer at MRLværdier ikke er påkrævet eller som ikke anses for at være omfattet af Forordning (EF) nr. 470/2009, når de anvendes i et veterinærlægemiddel.
English: Calves may uncommonly display a peak in temperature of at least 1.7°C two days after vaccination that resolves the next day without treatment.
Danish: Som en ikke almindelig bivirkning kan ses at kalve får en stigning i temperatur på mindst 1,7 °C to dage efter vaccinationen, som går over den følgende dag uden behandling.
English: For the 25 doses vial, once the freeze-dried powder is in suspension, withdraw all the suspension obtained from the vaccine vial and inject it into the vial containing the remaining solvent.
Danish: For hætteglasset med 25 doser: efter det frysetørrede pulver er suspenderet, skal hele suspensionen, der er hentet fra vaccinehætteglasset, fjernes og injiceres i hætteglasset, der indeholder den resterende solvens
English: Overdose (symptoms, emergency procedures, antidotes): No adverse reactions occurred following the administration of an overdose.
Danish: Overdosis (symptomer, nødforanstaltninger, modgift): Efter indgivelse af en overdosis, blev der ikke observeret nogen bivirkninger.
English: Shelf life of the solvent: 5 years
Danish: Opbevaringstid for solvens: 5 år.
English: Shake until the freeze-dried powder is in suspension.
Danish: Omryst indtil det frysetørrede pulver er suspenderet.
English: For nasal use, spray the required volume of the vaccine into the animal's nostrils (1 ml in each nostril) using an intranasal applicator (droplet size: 25-220 µm).
Danish: Til nasal brug sprøjtes den påkrævede mængde af vaccinen i dyrets næsebor (1 ml i hvert næsebor) med en intranasal applikator (dråbestørrelse: 25-220 µm).
English: Each dose of 2 ml contains: Lyophilisate:
Danish: Hver dosis på 2 ml indeholder: Lyofilisat:
English: Pharmacotherapeutic group: Immunological for Bovidae, Cattle, Live viral vaccines, bovine respiratory syncytial virus (BRSV).
Danish: Farmakoterapeutisk gruppe: Immunologiske midler til kvæg, levende virale vacciner, bovint respiratorisk syncytial virus vaccine (BRSV).
English: Withdrawal period(s): Zero days.
Danish: Tilbageholdelsestid(er): 0 dage.
English: 21 days after the second dose of the two dose intramuscular vaccination schedule.
Danish: 21 dage efter den anden dosis i forløbet med to doser intramuskulære vaccinationer.