FrancophonIA/ELRC3.0 huggingface dataset:
English: In cervical cancer, patients receiving the combination of Hycamtin and cisplatin survived an average of 9.4 months, compared with 6.5 months for the patients who received cisplatin only.
Danish: Ved livmoderhalskræft overlevede de patienter, der fik Hycamtin kombineret med cisplatin, gennemsnitligt i 9,4 måneder, sammenlignet med 6,5 måneder for de patienter, der kun fik cisplatin.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Hycamtin, including the appropriate precautions to be followed by healthcare professionals and patients.
Danish: På baggrund af denne er der anført sikkerhedsoplysninger i produktresuméet og indlægssedlen for Hycamtin, herunder passende forholdsregler, som patienter og sundhedspersonale skal følge.
English: The main measure of effectiveness was the number of patients whose tumours responded to treatment.
Danish: Behandlingens virkning blev hovedsagelig bedømt på antallet af patienter, hvis tumor reagerede positivt på behandlingen.
English: Infusions should be carried out in a specialised cancer ward.
Danish: Infusionerne bør indgives på en specialiseret kræftafdeling.
English: The CHMP decided that Hycamtin's benefits are greater than its risks and recommended that it be given marketing authorisation.
Danish: CHMP besluttede, at fordelene ved Hycamtin opvejer risiciene, og anbefalede udstedelse af en markedsføringstilladelse for Hycamtin.
English: The effectiveness was measured by looking at survival or response rates.
Danish: Virkningen blev bedømt på overlevelsesprocenten eller responsraten.
English: When Hycamtin is used on its own for ovarian cancer, it is given by intravenous infusion over 30 minutes.
Danish: Når Hycamtin anvendes alene til behandling af kræft i æggestokkene, gives det ved intravenøs infusion i løbet af 30 minutter.
English: Hycamtin must not be used in patients who are breast-feeding, or in patients who have severe bone marrow depression (low white blood cell and platelet counts) before treatment.
Danish: Hycamtin må ikke anvendes til patienter, der ammer, eller til patienter, der før behandlingen har svært knoglemarvssvigt (for lavt antal hvide blodlegemer og blodplader).
English: Hycamtin is a cancer medicine that contains the active substance topotecan.
Danish: Hycamtin er et kræftlægemiddel, der indeholder det aktive stof topotecan.
English: It is also used together with cisplatin (another cancer medicine) to treat women with cancer of the cervix, when the cancer has come back after radiotherapy, or when the disease is at an advanced stage (has spread beyond the cervix).
Danish: Det anvendes også sammen med cisplatin (et andet lægemiddel mod kræft) til behandling af kvinder med livmoderhalskræft ved tilbagefald af sygdommen efter strålebehandling, og når sygdommen er fremskreden (kræften har spredt sig fra livmoderhalsen).
English: What is the risk associated with Hycamtin?
Danish: Hvilken risiko er der forbundet med Hycamtin?
English: Hycamtin also affects non-cancer cells, which causes side effects.
Danish: Hycamtin påvirker også andre celler end kræftcellerne, hvilket medfører bivirkninger.
English: The active substance in Hycamtin, topotecan, is a cancer medicine that belongs to the group ‘topoisomerase inhibitors'.
Danish: Det aktive stof i Hycamtin, topotecan, er et lægemiddel mod kræft, der tilhører gruppen af "topoisomerasehæmmere".
English: Hycamtin given as capsules was as effective as Hycamtin given as an infusion.
Danish: Hycamtin givet i kapselform var lige så effektivt som Hycamtin givet som infusion.
English: Why has Hycamtin been approved?
Danish: Hvorfor blev Hycamtin godkendt?
English: For the full list of all side effects and restrictions with Hycamtin, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger og begrænsninger ved Hycamtin fremgår af indlægssedlen.
English: Hycamtin as an infusion has been studied in 293 women with advanced cervical cancer, where the effectiveness of a combination of Hycamtin and cisplatin was compared with that of cisplatin alone.
Danish: Hycamtin givet som infusion er blevet undersøgt hos 293 kvinder med fremskreden livmoderhalskræft, hvor virkningen af Hycamtin kombineret med cisplatin blev sammenlignet med virkningen af cisplatin alene.
English: When used with cisplatin in cervical cancer, Hycamtin is given as an infusion on days 1, 2 and 3 (with cisplatin given on day 1).
Danish: Når Hycamtin anvendes sammen med cisplatin til behandling af livmoderhalskræft, indgives det som en infusion på dag 1, 2 og 3 (cisplatin gives på dag 1).
English: One study compared Hycamtin capsules with symptom control alone and another compared Hycamtin as an infusion with cyclophosphamide, doxorubicin and vincristine (a standard combination of chemotherapy).
Danish: I den ene undersøgelse blev Hycamtin i kapselform sammenlignet med symptomkontrol alene, og i den anden blev Hycamtin som infusion sammenlignet med cyclophosphamid, doxorubicin og vinkristin (en almindeligt anvendt kombineret kemoterapi).
English: Hycamtin as an infusion has been studied in more than 480 women with ovarian cancer who had failed one treatment with platinum-containing cancer medicines.
Danish: Hycamtin givet som infusion blev undersøgt hos flere end 480 kvinder, som havde kræft i æggestokkene og var blevet behandlet med platinholdig kræftmedicin uden resultat.
English: Compared with symptom control alone, Hycamtin prolonged survival by
Danish: I forhold til symptomkontrol alene forlængede Hycamtin overlevelsen med 12 uger.
English: In ovarian cancer, the studies showed the effectiveness of Hycamtin, with an overall response rate of about 16%.
Danish: Ved kræft i æggestokkene viser undersøgelserne, at Hycamtin giver en samlet responsrate på ca. 16 %.
English: In lung cancer, looking at the results obtained in all three studies, the response rate was 20% (480 patients received Hycamtin).
Danish: Hvis resultaterne for lungekræft fra alle tre undersøgelser lægges sammen (480 patienter, der fik Hycamtin), var responsraten 20 %.
English: In the main study, 21% of the patients who received Hycamtin (23 out of 112) responded to treatment, compared with 14% of the paclitaxel patients (16 out of 114).
Danish: I hovedundersøgelsen reagerede 21 % af de patienter, der fik Hycamtin (23 ud af 112), positivt på behandlingen.
English: What is Hycamtin?
Danish: Hvad er Hycamtin?
English: For full details, see the summary of product characteristics, also part of the EPAR.
Danish: De nærmere oplysninger fremgår af produktresuméet (også en del af denne EPAR).
English: For both ovarian and lung cancer, Hycamtin is given every day for five days with a three-week interval between the start of each course.
Danish: Ved lungekræft kan Hycamtin gives som infusion eller, hos voksne, i kapselform Ved behandling af både kræft i æggestokkene og lungekræft gives Hycamtin hver dag i fem dage med et interval på tre uger mellem starten på hvert forløb.
English: The third study compared Hycamtin given as an infusion and as capsules.
Danish: I den tredje undersøgelse blev Hycamtin givet som infusion sammenlignet med Hycamtin i kapselform.
English: How has Hycamtin been studied?
Danish: Hvordan blev Hycamtin undersøgt?
English: What is Hycamtin used for?
Danish: Hvad anvendes Hycamtin til?
English: The fourth study involved 226 women, and compared Hycamtin with paclitaxel (another cancer medicine).
Danish: Her blev Hycamtin sammenlignet med paclitaxel (et andet kræftmiddel).
English: What benefit has Hycamtin shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Hycamtin?
English: How is Hycamtin used?
Danish: Hvordan anvendes Hycamtin?
English: How does Hycamtin work?
Danish: Hvordan virker Hycamtin?
English: 10 September 2012
Danish: Den 10. september 2012
English: The European Commission issued a decision on 10 September 2012.
Danish: Europa-Kommissionen traf en afgørelse den 10. september 2012.
English: What is Zinacef?
Danish: Hvad er Zinacef?
English: Zinacef is marketed in all EU Member States (except Germany, Latvia, Slovakia and Spain), as well as Iceland and Norway.
Danish: Zinacef markedsføres i alle EU's medlemsstater (undtagen Tyskland, Letland, Slovakiet og Spanien) samt i Island og Norge.
English: Zinacef is authorised in the EU via national procedures.
Danish: Zinacef blev godkendt i EU via nationale procedurer.
English: The company that markets these medicines is GlaxoSmithKline.
Danish: Den virksomhed, der markedsfører disse lægemidler, er GlaxoSmithKline.
English: It works by attaching to proteins on the surface of bacteria.
Danish: Det virker ved at binde sig til proteiner på bakteriernes overflade.
English: • Intra-abdominal infections.
Danish: • Intraabdominale infektioner
English: This prevents the bacteria from building their cell walls, and eventually kills them.
Danish: Dette forhindrer bakterierne i at danne cellevæggen, så de til sidst dør.
English: Why was Zinacef reviewed?
Danish: Hvorfor blev Zinacef vurderet igen?
English: It is also available under other trade names: Curocef, Curoxim, Curoxime, Zinnat.
Danish: Det leveres også under andre handelsnavne, nemlig Curocef, Curoxim, Curoxime og Zinnat.
English: On 24 May 2012, the European Medicines Agency completed a review of Zinacef.
Danish: Den 24. maj 2012 afsluttede Det Europæiske Lægemiddelagentur en gennemgang af Zinacef.
English: The CHMP also harmonised other sections of the SmPC including sections 4.3 (contra-indications) and 4.4 (special warnings and precautions for use).
Danish: CHMP harmoniserede desuden andre afsnit af produktresuméet, herunder afsnit 4.3 (Kontraindikationer) og 4.4 (Særlige advarsler og forsigtighedsregler vedrørende brugen).
English: The CHMP concluded that Zinacef should be used in adults and children from birth for the following conditions:
Danish: CHMP konkluderede, at Zinacef bør anvendes til voksne og børn fra fødslen til følgende indikationer:
English: On 20 April 2010, the European Commission referred the matter to the CHMP in order to harmonise the marketing authorisations for Zinacef in the EU.
Danish: Den 20. april 2010 indbragte Europa-Kommissionen sagen for CHMP med henblik på at harmonisere markedsføringstilladelserne for Zinacef i EU.
English: Having harmonised the indications, the CHMP also harmonised the recommendations on the use of Zinacef in adults and children and in patients with reduced kidney and liver function.
Danish: Foruden indikationerne harmoniserede CHMP også anbefalingerne for brug af Zinacef hos voksne og børn og hos patienter med nedsat nyre- eller leverfunktion.
English: The CHMP agreed that Zinacef should no longer be used to treat severe ear, nose and throat infections as well as bone and joint infections and gonorrhoea (a sexually transmitted infection caused by bacteria called Neisseria gonorrhoeae), because not enough clinical data are available to support these indications.
Danish: CHMP fandt, at Zinacef ikke længere burde anvendes til behandling af svære infektioner i øre, næse og hals eller infektioner i knogler og led samt ved gonoré (en seksuelt overført sygdom forårsaget af bakterien Neisseria gonorrhoeae), da der ikke findes tilstrækkelige kliniske data til støtte for disse indikationer.
English: The active substance, cefuroxime sodium, belongs to the group ‘cephalosporins'.
Danish: Det aktive stof, cefuroximnatrium, tilhører gruppen cefalosporiner.
English: • Acute exacerbations (flares-up) of chronic bronchitis.
Danish: • Akutte eksacerbationer (opblussen) af kronisk bronkitis
English: Zinacef should be given by injection into a vein over a period of 3 to 5 minutes, by infusion over 30 to 60 minutes, or by deep intramuscular injection, at different doses depending on the condition it is used to treat.
Danish: Zinacef gives enten ved injektion i en vene over en periode på 3-5 minutter, ved infusion over en periode på 30-60 minutter eller ved dyb intramuskulær injektion.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that there is a need to harmonise the prescribing information for Zinacef in the European Union (EU).
Danish: EMA's Udvalg for Lægemidler til Mennesker (CHMP) konkluderede, at der er behov for harmonisering af produktinformationen for Zinacef i Den Europæiske Union (EU).
English: The CHMP also decided that Zinacef should no longer be used in sequential therapy (when switching patients from an injectable to an oral treatment) due to a significant reduction in exposure to the active substance when switching to the oral formulation.
Danish: CHMP besluttede desuden, at Zinacef ikke længere burde anvendes til sekvensbehandling (dvs. skift fra injektioner til oral behandling), fordi overgang til den orale behandling medførte en betydeligt lavere eksponering for det aktive stof.
English: Zinacef is an antibiotic used to treat certain bacterial infections, including pneumonia (infection of the lungs), urinary tract infections (infections of the structures that carry urine), soft-tissue infections (infections of tissues just below the skin), infections within the abdomen, as well as to prevent infections during surgery.
Danish: Zinacef er et antibiotikum, der anvendes til behandling af visse bakterielle infektioner, herunder lungebetændelse, urinvejsinfektioner, bløddelsinfektioner (infektioner i hudens underliggende væv) og infektioner i maveregionen samt til forebyggelse af infektioner i forbindelse med operationer.
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 grundlag af de forelagte data og den videnskabelige drøftelse i udvalget fandt CHMP, at produktresuméer, etikettering og indlægssedler skulle harmoniseres i EU.
English: • Soft-tissue infections: cellulitis, erysipelas and wound infections.
Danish: • Bløddelsinfektioner: cellulitis, erysipelas (rosen) og sårinfektioner
English: • Complicated urinary tract infections, including pyelonephritis (kidney infection).
Danish: • Komplicerede urinvejsinfektioner, herunder pyelonefritis (infektion i nyrerne)
English: cardiovascular, and gynaecological surgery (including caesarean section).
Danish: ortopædkirurgi samt kardiovaskulære og gynækologiske operationer (herunder kejsersnit).
English: • Community-acquired (acquired outside the hospital) pneumonia.
Danish: • Samfundserhvervet lungebetændelse (lungebetændelse erhvervet uden for hospitalet)
English: Zinacef was identified as needing harmonisation by the Co-ordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh).
Danish: Koordinationsgruppen vedrørende gensidig anerkendelse og decentral procedure - lægemidler til mennesker (CMD(h)) vurderede, at der er behov for harmonisering for Zinacef.
English: • Prophylaxis against infection in gastrointestinal (including oesophageal), orthopaedic,
Danish: • Forebyggelse af infektion ved operationer i mave-tarmkanalen (herunder spiserøret),
English: In case of anaphylactic shock, appropriate symptomatic treatment should be administered.
Danish: I tilfælde af anafylaktisk shock, bør en korrekt symptomatisk behandling administreres.
English: ATCvet code: QI06AA01.
Danish: ATCvet-kode: QI06AA01
English: A moderate and transient local reaction (<2 cm) is commonly observed after the first injection.
Danish: En moderat og forbigående lokal reaktion (<2 cm) er almindeligt forekommende efter den første injektion.
English: A decision to use this vaccine before or after another veterinary medicinal product therefore needs to be made on a case by case basis.
Danish: Brug af vaccinen før eller efter brug af et andet veterinærlægemiddel bør derfor vurderes i det enkelte tilfælde.
English: VIRBAC Hungary KFT Szent Istvàn krt.11.II/21.
Danish: HU: Magyarország VIRBAC Hungary KFT Szent Istvàn krt.11.II/21.
English: Date of first authorisation: 17/06/2009.
Danish: Dato for første tilladelse: 17/06/2009 Dato for fornyelse af tilladelsen: 12/06/2014
English: Maternally derived antibodies can negatively influence the immune response to vaccination.
Danish: Maternelle antistoffer kan påvirke immunresponset på vaccinen negativt.
English: Sodium chloride Disodium phosphate anhydrous Potassium dihydrogen phosphate Aluminium hydroxide gel Quillaja saponaria Water for injections
Danish: Natriumchlorid Dinatriumpfosphatdihydrat Kaliumdihydrogenphosphat Aluminiumhydroxid gel Quillaja saponaria Vand til injektionsvæske
English: Pharmacotherapeutic group: immunologicals for Felidae, inactivated viral vaccines for cats.
Danish: Farmakoterapeutisk gruppe: immunologicals for Felidae, inaktiverede virale vacciner til katte.
English: Primary vaccination: - first injection in kittens from eight weeks of age - second injection 3 or 4 weeks later.
Danish: Basisvaccination: - første injektion fra killingerne er 8 uger gamle - anden injektion 3 til 4 uger senere.
English: VIRBAC Sp. z o.o.
Danish: PL: Polska VIRBAC Sp. z o.o.
English: This local reaction could be a swelling, an oedema or a nodule and resolves spontaneously within from 3 to 4 weeks at the most.
Danish: Denne lokale reaktion kan være i form af ødem, hævelse eller knudedannelse, som forsvinder spontant inden for 3 til 4 uger.
English: Active immunisation of cats from eight weeks of age against feline leukaemia for the prevention of persistent viraemia and clinical signs of the related disease.
Danish: Aktiv immunisering af katte, der er 8 uger gamle eller ældre, mod felin leukæmi til forebyggelse af persisterende viræmi og kliniske symptomer på den relaterede sygdom.
English: VIRBAC Tierarzneimittel GmbH Rögen 20
Danish: DE: Deutschland VIRBAC Tierarzneimittel GmbH Rögen 20
English: The use is not recommended during lactation.
Danish: Anvendelse frarådes under laktation.
English: Name and address of the manufacturer of the biological active substance
Danish: Navn og adresse på fremstilleren af det biologisk aktive stoffer
English: VIRBAC Nederland BV Hermesweg 15
Danish: NL: Nederland VIRBAC Nederland BV Hermesweg 15
English: Immediate packaging:
Danish: Indre emballage:
English: Vaccine against feline leukaemia.
Danish: Vaccine mod felin leukæmi.
English: The transient signs following vaccination such as hyperthermia (lasting 1 to 4 days), apathy and digestive disturbances may also be commonly observed.
Danish: Forbigående symptomer, såsom: hyperthermi (der sædvanligvis varer 1 til 4 dage), apati og fordøjelsesforstyrrelser efter vaccination, kan også almindeligvis observeres.
English: Therefore, a test for presence of FeLV before vaccination is recommended.
Danish: Det anbefales derfor at udføre en test for FeLV forud for vaccination.
English: VIRBAC Österreich GmbH Hildebrandgasse 27
Danish: AT: Österreich VIRBAC Österreich GmbH Hildebrandgasse 27
English: Opalescent liquid.
Danish: Opaliserende væske.
English: T.K.14452, Μεηαμόρθωζη,
Danish: Αθηνών - Λαμίας, T.K.14452, Μεηαμόρθωζη, Ελλάδα
English: Special precautions for use in animals De-worming at least 10 days prior to vaccination is recommended.
Danish: Særlige forsigtighedsregler vedrørende brug til dyr Ormebehandling anbefales mindst 10 dage før vaccination.
English: Protection against persistent viraemia is observed in 73% of cats 3 weeks after their first vaccine injection.
Danish: Beskyttelse mod persisterende viræmi er vist hos 73 % af katte 3 uger efter første vaccination.
English: FI : Suomi/Finland
Danish: FI : Suomi/Finland VIRBAC
English: 13o χλμ Ε.Ο.
Danish: VIRBAC Hellas SA 13o χλμ Ε.Ο.
English: Following a first booster vaccination one year after the primary vaccination course, subsequent vaccinations can be performed at intervals of three years.
Danish: Efter en boostervaccination givet 1 år efter endt basisvaccination kan efterfølgende vaccinationer gives med intervaller på 3 år.
English: No adverse reactions were observed after an overdose administration (2 doses) of the veterinary medicinal product other than those mentioned in section 4.6 except local reactions that can last longer (from 5 to 6 weeks at the most).
Danish: Der er ikke observeret nogen bivirkninger som følge af overdosering (dobbeltdosis) med det veterinære lægemiddel, udover de i afsnit 4.6 nævnte, bortset fra lokale reaktioner, der kan vare længere (maksimalt 5 til 6 uger).
English: 102 µg
Danish: 102 mikrog.
English: No information is available on the safety and efficacy of this vaccine when used with any other veterinary medicinal product except the products mentioned above.
Danish: Der foreligger ingen oplysninger om sikkerhed og virkning ved brug af vaccinen sammen med andre veterinære lægemidler.
English: Shake the vial gently and administer subcutaneously one dose (1 ml) of the veterinary medicinal product according to the following regimen of vaccination.
Danish: Hætteglasset rystes let, og en dosis (1 ml) af veterinærlægemidlet administreres subkutant i henhold til følgende vaccinationsprogram.
English: Shake the vial gently before use.
Danish: Hætteglasset rystes let før brug.
English: 3% aluminium hydroxide gel expressed as mg Al3+
Danish: Adjuvanser: 3 % aluminiumhydroxidgel udtrykt som mg Al
English: No adverse reactions were observed after an overdose administration of the veterinary medicinal product other than those mentioned in section 6, except local reactions that can last longer (from 5 to 6 weeks at the most).
Danish: Der er ikke blevet observeret nogle bivirkninger efter overdosering (dobbeltdosis) med det veterinære lægemiddel, foruden de nævnte punkt 6, ud over lokale reaktioner, der kan vare længere (maksimalt 5 til 6 uger).
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Vial label
Danish: MINDSTEKRAV TIL OPLYSNINGER PÅ SMÅ INDRE PAKNINGER
English: Type I glass vials containing one dose (1 ml) of the vaccine closed with a 13 mm-diameter butyl elastomer stopper and aluminium capsule.
Danish: Hætteglas af type I glas indeholdende en dosis (1 ml) vaccine lukket med en 13 mm-diameter butylelastomer prop, fastgjort med en aluminiumskapsel.
English: VIRBAC Belgium NV Esperantolaan 4
Danish: BE/ België/Belgique VIRBAC Belgium NV Esperantolaan 4
English: HR : Hrvatska
Danish: HR : Hrvatska VIRBAC
English: Plastic or cardboard box of 10 vials.
Danish: Æske af plast eller karton med 10 hætteglas.
English: Incompatibilities: Do not mix with any other veterinary medicinal product except FELIGEN RCP or FELIGEN CRP.
Danish: Uforligeligheder: Må ikke blandes med andre lægemidler til dyr undtaget FELIGEN CRP eller FELIGEN RCP.
English: Plastic or cardboard box of 50 vials.
Danish: Æske af plast eller karton med 50 hætteglas.
English: Do not mix with any other veterinary medicinal product except FELIGEN RCP or FELIGEN CRP.
Danish: Må ikke blandes med andre lægemidler til dyr undtaget FELIGEN CRP eller FELIGEN RCP.
English: VIRBAC Danmark A/S Profilvej 1
Danish: DK: Danmark VIRBAC Danmark A/S Profilvej 1
English: BG: Република България
Danish: BG: Република България VIRBAC
English: 06517 Carros France service-conso@virbac.fr
Danish: FR : France VIRBAC France 13e rue LID 06517 Carros France service-conso@virbac.fr
English: Shelf life after first opening the immediate packaging: use immediately.
Danish: Opbevaringstid efter første åbning af den indre emballage: Anvendes umiddelbart efter åbning.
English: CZ: Česká republika
Danish: CZ: Česká republika VIRBAC
English: Safety and efficacy data are available which demonstrate that this vaccine can be mixed and administered with FELIGEN CRP and FELIGEN RCP.
Danish: Tilgængelige data for sikkerhed og effektivitet demonstrerer, at vaccinen kan blandes med og anvendes samtidig med FELIGEN CRP og FELIGEN RCP.
English: Safety and efficacy data are available which demonstrate that this vaccine can be mixed and administered with FELIGEN CRP or FELIGEN RCP.
Danish: Der foreligger oplysninger om sikkerhed og virkning, som viser, at vaccinen kan blandes med og anvendes samtidig med FELIGEN CRP eller FELIGEN RCP.
English: Minimum quantity of purified p45 FeLV-envelope antigen: 102 µg
Danish: Aktivt stof: Minimumsmængde af renset p45-FeLV-envelope-antigen: 102 mikrog./ml