FrancophonIA/ELRC3.0 huggingface dataset:
English: • Swelling in arms or legs (oedema)
Danish: • Hævelse i arme eller ben på grund af væskeansamling (ødem)
English: Women of childbearing potential/Contraception in males and females Since dexrazoxane possesses mutagenic activity and is used with anthracyclines known to have cytotoxic, mutagenic and embryotoxic properties, both sexually active men and women of childbearing potential should be advised not to father a child/become pregnant and must use effective contraceptive measures during and up to 6 months after treatment.
Danish: Fertile kvinder/kontraception hos mænd og kvinder Da dexrazoxan har mutagen aktivitet og anvendes sammen med anthracycliner, der vides at have cytotoksiske, mutagene og embryotoksiske egenskaber, skal både seksuelt aktive mænd og fertile kvinder rådes til ikke at blive far/blive gravide og skal anvende effektive kontraceptionsmetoder under og i op til 6 måneder efter behandlingen.
English: One emergency kit contains 10 vials of Savene powder and 3 bottles of Savene solvent supplied with 3 bottle hangers.
Danish: Et nødhjælpssæt indeholder 10 hætteglas Savene-pulver og 3 flasker solvens til Savene leveret med 3 flaskeophæng.
English: Day 3: 500 mg/m2
Danish: 500 mg/m2
English: STORAGE
Danish: OPBEVARING
English: The concentration of dexrazoxane following reconstitution with 25 ml Savene solvent is 20 mg/ml.
Danish: Koncentrationen af dexrazoxan efter rekonstituering med 25 ml solvens til Savene-er 20 mg/ml.
English: Clinical trial TT04 was conducted on 6 female patients undergoing treatment for anthracycline extravasations.
Danish: Farmakokinetik hos patienter med ekstravasationer Det kliniske studie TT04 blev udført med 6 kvindelige patienter, der var i behandling for antracyklinekstravasationer.
English: If the powder or solution contacts the skin or mucous membranes, wash immediately and thoroughly with water.
Danish: Hvis pulver eller injektionsvæske kommer i kontakt med hud eller slimhinder, skylles straks grundigt med vand.
English: Based on the required dose for the patient expressed in mg, withdraw aseptically the corresponding volume containing 20 mg dexrazoxane per ml from the appropriate number of vials containing concentrate.
Danish: Den dosis, patienten skal have, udtrykt i mg, trækkes aseptisk op fra det relevante antal hætteglas med koncentrat, som indeholder 20 mg dexrazoxan pr. ml.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 500 mg dexrazoxane
Danish: INDHOLD ANGIVET SOM VÆGT, VOLUMEN ELLER ANTAL DOSER 500 mg dexrazoxan
English: 4.2 After reconstitution and dilution: - Chemical and physical in-use stability after reconstitution and subsequent dilution in the solvent has been demonstrated for 4 hours when stored at 2 to 8 °C.
Danish: 4.2 Efter rekonstitution og fortynding - Kemisk og fysisk stabilitet under brug efter rekonstitution og efterfølgende fortynding i solvenset er påvist i 4 timer ved opbevaring ved 2 til 8° C - For at undgå potentiel forurening af lægemidlet med mikrober skal produktet anvendes straks.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Savene 20 mg/ml powder for concentrate dexrazoxane
Danish: LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E) Savene 20 mg/ml pulver til koncentrat dexrazoxan
English: No of patients with post baseline value
Danish: Antallet af patienter med postbaselineværdi
English: Most common adverse reactions are nausea/vomiting, bone marrow suppression (neutropenia, thrombocytopenia), injection site reactions, diarrhoea, stomatitis and increase in hepatic transaminases (ALT/AST).
Danish: De hyppigste bivirkninger er kvalme/opkastning, knoglemarvsdepression (neutropeni, trombocytopeni), reaktioner på injektionsstedet, diarré, stomatitis og forhøjede levertransaminaser (ALAT/ASAT).
English: After reconstitution with 25 ml Savene solvent, 1 ml of concentrate contains 20 mg dexrazoxane.
Danish: Efter rekonstitution med 25 ml solvens til Savene indeholder 1 ml koncentrat 20 mg dexrazoxan.
English: Savene is available as an emergency kit consisting of 10 vials of Savene powder and 3 bottles of Savene solvent supplied with 3 bottle hangers.
Danish: Savene leveres i et nødhjælpssæt, der indeholder 10 hætteglas med Savene-pulver og 3 flasker med solvens til Savene med 3 medfølgende flaskeophæng.
English: Injection site phlebitis Injection site erythema Fatigue
Danish: Flebitis på injektionsstedet Erytem på injektionsstedet Træthed
English: Day 2: 1000 mg/m2
Danish: 1.000 mg/m2
English: For instructions on reconstitution and dilution of the medicinal product before administration, see section 6.6.
Danish: 6.6 for at få instruktioner om rekonstitution og fortynding af lægemidlet før administration.
English: Because of the potential for serious adverse reactions in breast-fed infants exposed to dexrazoxane, breast-feeding is contraindicated during Savene therapy (see section 4.3).
Danish: På grund af risikoen for alvorlige bivirkninger hos ammede børn, som eksponeres for dexrazoxan, er amning kontraindiceret under behandlingen med Savene.
English: Keep vials and bottles in the outer carton in order to protect from light.
Danish: Opbevar hætteglas og flasker i den ydre karton for at beskytte mod lys.
English: There is limited information about the effect of Savene on fertility - if you have a concern about this speak to you doctor.
Danish: Oplysningerne om Savenes virkning på fertiliteten er begrænsede.
English: - A product called DMSO (which is a cream to treat some skin diseases).
Danish: - Et præparat, der kaldes DMSO (som er en creme til behandling af nogle former for hudsygdomme) - Phenytoin (en behandling mod krampeanfald) (Savene kan nedsætte virkningen af denne behandling).
English: Postoperative infection
Danish: Meget almindelig Postoperativ infektion Almindelig
English: Sodium chloride, Potassium chloride, Magnesium chloride hexahydrate, Sodium acetate trihydrate, Sodium gluconate, Sodium hydroxide, Water for injections.
Danish: Magnesiumchloridhexahydrat, Natriumacetattrihydrat, Natriumgluconat, Natriumhydroxid, Vand til injektionsvæsker.
English: Since renal dysfunction may decrease the rate of elimination of dexrazoxane, patients with impaired renal function should be monitored for signs of haematological toxicity (see section 4.2 for dosing recommendations in patients with moderate to severe renal impairment (creatinine clearance <40 mL/min)).
Danish: Da nyredysfunktion kan nedsætte eliminationshastigheden af dexrazoxan, skal patienter med nedsat nyrefunktion monitoreres for tegn på hæmatologisk toksicitet (se pkt.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 28 July 2006
Danish: DATO FOR FØRSTE MARKEDSFØRINGSTILLADELSE/FORNYELSE AF TILLADELSEN
English: There is limited evidence from studies that suggests epirubicin clearance may be increased when dexrazoxane is pre-administered, this occurred at high doses of epirubicin (120-135 mg/m2).
Danish: Der er begrænset evidens fra studier, der tyder på, at epirubicins clearance kan være forhøjet efter forudgående administration af dexrazoxan.
English: PHARMACEUTICAL FORM Powder and solvent for concentrate for solution for infusion.
Danish: LÆGEMIDDELFORM OG INDHOLD (PAKNINGSSTØRRELSE) Pulver og solvens til koncentrat til infusionsvæske, opløsning.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each vial contains 500 mg dexrazoxane (589 mg dexrazoxane hydrochloride).
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hvert hætteglas indeholder 500 mg dexrazoxan (589 mg dexrazoxanhydroklorid).
English: Each vial contains 500 mg dexrazoxane (589 mg dexrazoxane hydrochloride).
Danish: Hvert hætteglas indeholder 500 mg dexrazoxan (589 mg dexrazoxanhydrochlorid).
English: Do not use Savene: - If you are allergic to dexrazoxane or any of the other ingredients of this medicine (listed in section 6) - If you are planning to become pregnant and do not use adequate contraceptive measures - If you are breast-feeding - If you are given yellow-fever vaccine
Danish: (angivet i punkt 6) - Hvis De planlægger at blive gravid og ikke anvender en tilstrækkelig sikker præventionsmetode - Hvis De ammer - Hvis De får vaccine mod gul feber
English: • Itching (pruritus)
Danish: • Amning (se pkt.
English: Savene is an anti-cancer agent and the normal procedures for proper handling and disposal of anticancer medicines should be adopted, namely: - Personnel should be trained to reconstitute the medicine - Pregnant staff should be excluded from working with this medicine - Personnel handling this medicine during reconstitution should wear protective clothing including mask, goggles and gloves - Accidental contact with the skin or eyes should be treated immediately and thoroughly with copious amounts of water
Danish: Savene er et lægemiddel mod cancer, og de normale procedurer for korrekt håndtering og bortskaffelse af et lægemiddel mod cancer skal anvendes, det vil sige: - Personalet skal oplæres i at rekonstituere lægemidlet.
English: Sodium chloride Potassium chloride Magnesium chloride hexahydrate Sodium acetate trihydrate Sodium gluconate Sodium hydroxide Water for injections
Danish: Magnesiumchloridhexahydrat Natriumacetattrihydrat Natriumgluconat Natriumhydroxid Vand til injektionsvæsker
English: • Vaginal bleeding
Danish: • Vaginal blødning
English: Powder vial none
Danish: Hætteglas med pulver Ingen
English: NAME OF THE MEDICINAL PRODUCT Savene 20 mg/ml powder and solvent for concentrate for solution for infusion.
Danish: LÆGEMIDLETS NAVN Savene 20 mg/ml pulver og solvens til koncentrat til infusionsvæske, opløsning.
English: Dyspnoea Pneumonia
Danish: Dyspnø Pneumoni
English: Savene 20 mg/ml powder and solvent for concentrate for solution for infusion Dexrazoxane
Danish: Savene 20 mg/ml pulver og solvens til koncentrat til infusionsvæske, opløsning Dexrazoxan
English: Very common
Danish: Meget almindelig Kvalme Almindelig
English: Injection site induration Injection site swelling Peripheral oedema Somnolence
Danish: Induration på injektionsstedet Hævelse på injektionsstedet Perifert ødem
English: Powder vial:
Danish: Hætteglas med pulver:
English: Each vial contains 500 mg dexrazoxane as 589 mg dexrazoxane hydrochloride.
Danish: Hvert hætteglas indeholder 500 mg dexrazoxan (som 589 mg dexrazoxanhydrochlorid).
English: Wound complication
Danish: Sårkomplikation
English: Hepatic impairment
Danish: hypotension, pludselig bevidstløshed
English: Preparation guide for use with Savene 20 mg/ml powder and solvent for concentrate for solution for infusion
Danish: Vejledning i tilberedning af Savene 20 mg/ml pulver og solvens til koncentrat til infusionsvæske, opløsning
English: wheezing, breathlessness or difficult breathing, changes in levels of consciousness, hypotension,
Danish: • Allergiske reaktioner med symptomer som kløe, udslæt, hævelse af ansigt og hals, hvæsende vejrtrækning, stakåndethed eller besværet vejrtrækning, ændringer i bevidsthedsniveau,
English: What Savene is and what it is used for What you need to know before you use Savene How to use Savene
Danish: Det skal De vide, før De begynder at bruge Savene Sådan skal De bruge Savene Bivirkninger
English: • Nausea
Danish: • Kløe
English: Keep the powder vials and solvent bottles in the outer carton in order to protect from light.
Danish: Opbevares ved temperaturer under 25 oC. Opbevar hætteglas med pulver og flasker med solvens i den ydre karton for at beskytte mod lys.
English: • Difficulties in breathing
Danish: • Vejrtrækningsbesvær
English: • Pneumonia (lung infection)
Danish: • Lungebetændelse
English: Nausea
Danish: Døsighed
English: • Dexrazoxane may add to the toxicity induced by the chemotherapy cycle during which the accident took place, requiring careful monitoring of haematological parameters (see section 4.4).
Danish: • Dexrazoxan kan øge toksiciteten af den kemoterapicyklus, i hvilken uheldet fandt sted.
English: Injection site pain
Danish: Meget almindelig Smerter på injektionsstedet Almindelig
English: 4.1 Before reconstitution and dilution: - Store below 25 °C.
Danish: 4.1 Før rekonstitution og fortynding - Opbevares ved temperaturer under 25° C. - Opbevar hætteglassene med pulver og flaskerne med solvens i den udvendige pakning for at beskytte indholdet mod lys.
English: EU (MA) number Invented name Strength Pharmaceutical form Target species Route of administration Packaging Content Package size Withdrawal period
Danish: EU-nummer Særnavn Styrke Lægemiddelform Dyrearter, som læge-midlet er beregnet til Indgivelsesvej Emballage Indhold Pakningss-tørrelse Tilbageholdelsestid
English: More about Semler
Danish: Mere om Semler
English: The review of Semler was initiated on 28 April 2016 at the request of Denmark, Germany, the Netherlands, Spain and the United Kingdom under Article 31 of Directive 2001/83/EC.
Danish: Gennemgangen af Semler blev indledt den 28. april 2016 efter anmodning fra Danmark, Tyskland, Nederlandene, Spanien og Det Forenede Kongerige i medfør af artikel 31 i direktiv 2001/83/EF.
English: The list of medicines recommended to remain on the market can be found here.
Danish: Listen over lægemidler, der anbefales bibeholdt på markedet, kan ses her.
English: The CHMP opinion was forwarded to the European Commission, which issued a final legally binding decision applicable in all EU Member States on 22 September 2016.
Danish: CHMP's udtalelse blev fremsendt til Europa-Kommissionen, som traf en endelig juridisk bindende beslutning med gyldighed i alle EU-medlemsstater den 22. september 2016.
English: • Patients should continue to take their medicines as prescribed and contact their doctors in case of questions or concerns.
Danish: • Patienterne skal fortsætte med at tage deres lægemidler som ordineret og kontakte deres læge, hvis de har spørgsmål.
English: Therefore national authorities can temporarily postpone the suspension in the interest of patients.
Danish: De nationale myndigheder kan derfor udskyde suspensionen midlertidigt, hvis det er kritisk nødvendigt for patienterne.
English: Member States should also decide whether recalls of the affected medicines are needed in their territories.
Danish: De enkelte medlemsstater skal også afgøre, om det er nødvendigt at trække de berørte lægemidler tilbage i deres land.
English: During the evaluation, alternative studies were provided for some of these medicines.
Danish: Under vurderingen blev der fremsendt andre undersøgelser for nogle af lægemidlerne.
English: • National authorities in the EU will consider how critical individual medicines are in their countries and make final decisions on whether to suspend or allow them to remain available, while new data are generated.
Danish: • De nationale myndigheder i EU vil vurdere, hvor kritisk nødvendige de enkelte lægemidler er i deres land, og træffe endelig afgørelse om, hvorvidt de skal suspenderes eller blive på markedet, mens nye data fremskaffes.
English: • Medicines that have been suspended can have their suspension lifted if the companies provide alternative data demonstrating bioequivalence.
Danish: • Lægemidler, der er blevet suspenderet, kan få ophævet suspensionen, hvis virksomhederne fremsender andre data, der påviser bioækvivalens.
English: Thus, no medicines can be approved on the basis of these studies.
Danish: Der kan således ikke ske godkendelse af lægemidler på baggrund af disse undersøgelser.
English: The review was carried out by the Committee for Medicinal Products for Human Use (CHMP), responsible for questions concerning medicines for human use, which has adopted the Agency's opinion.
Danish: Gennemgangen blev udført af Udvalget for Lægemidler til Mennesker (CHMP), som har ansvar for alle spørgsmål vedrørende lægemidler til mennesker, og som vedtog agenturets udtalelse.
English: Semler is a contract research organisation (CRO) with an analytical and a clinical site located in Bangalore, India.
Danish: Semler er en kontraktforskningsorganisation med en analytisk og en klinisk enhed, der er beliggende i Bangalore, Indien.
English: The CHMP's recommendation concerning these medicines was sent to the European Commission for a legally binding decision valid throughout the EU.
Danish: CHMP's anbefaling vedrørende disse lægemidler er blevet fremsendt til Europa-Kommissionen med henblik på en juridisk bindende beslutning, der gælder hele EU.
English: Some of the medicines which have been recommended for suspension may be of critical importance (e.g. due to lack of available alternatives) in a given EU Member State.
Danish: Nogle af de lægemidler, der anbefales suspenderet, kan være kritisk nødvendige for patienterne i en given medlemsstat (f.eks. fordi der mangler andre behandlingsmuligheder).
English: Tel. +44 (0)20 3660 8427 E-mail: press@ema.europa.eu http://www.who.int/prequal
Danish: Tlf. +44 (0) 20 3660 8427 E-mail: press@ema.europa.eu http://www.who.int/prequal
English: This is because during this review, alternative studies from different sources were provided that show bioequivalence.
Danish: Det skyldes, at der under denne gennemgang er fremlagt andre undersøgelser fra andre kilder, hvor man har påvist bioækvivalens.
English: These studies show bioequivalence, and therefore, the CHMP recommended that these medicines can remain on the market.
Danish: De andre undersøgelser viser bioækvivalens, og derfor anbefaler CHMP, at disse lægemidler bliver på markedet.
English: • Generic medicines containing abacavir/lamivudine (used to treat HIV), which were approved on the basis of studies conducted at Semler, can remain on the market in the EU.
Danish: • Generiske lægemidler, der indeholder abacavir/lamivudin (til behandling af hiv), og som er godkendt på grundlag af undersøgelser, der er udført hos Semler, kan blive på markedet i EU.
English: The review covered medicines authorised via national procedures in individual EU Member States, whose marketing authorisation applications included data from Semler's bioanalytical site (Semler Research Center Private Ltd, 75A, 15th Cross, 1st Phase, JP Nagar, Bangalore 560 078, Karnataka, India) and from Semler's clinical site (PA Arcade, #21, 22, 23, Kodigehali Main Road, Sahakaranagar Post, Bangalore 560 092, Karnataka, India).
Danish: Yderligere oplysninger om de lægemidler, der er omfattet af denne gennemgang Ved denne gennemgang har EMA set på lægemidler, der er godkendt gennem nationale procedurer i medlemsstater, hvis ansøgninger om markedsføringstilladelse omfatter data fra Semlers bioanalytiske enhed (Semler Research Centre Private Ltd, 75A, 15th Cross, 1st Phase, JP Nagar, Bangalore 560 078, Karnataka, Indien) og Semlers kliniske enhed (PA Arcade, #21, 22, 23, Kodigehali Main Road, Sahakaranagar Post, Bangalore 560 092, Karnataka, Indien).
English: No generic medicine authorised centrally via EMA was tested in these sites.
Danish: Ingen generiske lægemidler, der er godkendt centralt via EMA, har været underkastet undersøgelser på disse enheder.
English: On 21 July 2016, the European Medicines Agency (EMA) recommended suspending a number of nationally approved medicines for which bioequivalence studies were conducted at Semler Research Centre Private Ltd, Bangalore, India.
Danish: Den 21. juli 2016 anbefalede Det Europæiske Lægemiddelagentur (EMA), at en række nationalt godkendte lægemidler, der har været underkastet bioækvivalensundersøgelser på Semler Research Centre Private Ltd, Bangalore, Indien, skal suspenderes.
English: The Semler site also performs bioequivalence studies for some medicines authorised in the US and medicines included in the WHO prequalification programme3.
Danish: Semler udfører også bioækvivalensundersøgelser for en række lægemidler, der godkendes i USA, samt lægemidler, der er omfattet af WHO's prækvalifikationsprogram3.
English: These sites conduct the analytical and clinical parts of bioequivalence studies, some of which are used to support marketing authorisation applications of medicines in the EU.
Danish: Disse enheder udfører den analytiske og den kliniske del af bioækvivalensundersøgelser, hvoraf nogle bruges til at understøtte ansøgninger om markedsføringstilladelse for lægemidler i EU.
English: • There is currently no evidence of unexpected harm or lack of effectiveness with any medicine approved on the basis of studies conducted at Semler.
Danish: • Indtil videre er der ingen dokumentation for uventede skader eller manglende effektivitet ved lægemidler, som er godkendt på grundlag af undersøgelser, der er udført hos Semler.
English: EMA's Committee for Medicinal Products for Human Use (CHMP) concluded that the studies conducted at Semler cannot be accepted in marketing authorisation applications in the EU.
Danish: EMA's Udvalg for Lægemidler til Mennesker (CHMP) konkluderede, at undersøgelser, der er udført hos Semler, ikke kan accepteres som støtte ved ansøgninger om markedsføringstilladelse i EU.
English: The Agency also recommended that medicines being evaluated for authorisation and which rely only on bioequivalence studies from this site should not be authorised until bioequivalence is demonstrated using alternative data.
Danish: Agenturet anbefalede også, at lægemidler, der er ved at blive vurderet med henblik på godkendelse, og som har været underkastet bioækvivalensundersøgelser hos Semler, ikke bør godkendes, før man har påvist bioækvivalens ud fra andre data.
English: • The bioequivalence studies performed at the Semler site have been found to be flawed, so they cannot be relied on. As a result, several medicines approved in the EU have been suspended.
Danish: • Det er blevet konstateret, at de bioækvivalensundersøgelser, der udføres hos Semler, er fejlbehæftede, hvorfor man ikke kan fæste lid til dem. Flere godkendte lægemidler i EU er derfor blevet suspenderet.
English: The findings from FDA and WHO inspections called into question the quality management system in place at Semler, and thus the reliability of the data of all bioequivalence studies, including those used to support marketing authorisation applications in the EU.
Danish: Fundene fra FDA's og WHO's inspektioner gav også anledning til at sætte spørgsmålstegn ved kvalitetssikringssystemet hos Semler og dermed ved pålideligheden af dataene fra alle bioækvivalensundersøgelserne, herunder de data, der bruges til at understøtte ansøgninger om markedsføringstilladelse i EU.
English: The World Health Organization (WHO) also raised serious concerns2 regarding data integrity and manipulation of study samples following its own inspections of Semler's bioanalytical and clinical sites.
Danish: Verdenssundhedsorganisationen (WHO) fandt også alvorlige problemer2 med hensyn til dataintegritet og manipulation med prøverne, da den gennemførte sine inspektioner af Semlers bioanalytiske og kliniske enheder.
English: EMA's review followed an FDA inspection1 that identified several issues at Semler's bioanalytical site, including the substitution and manipulation of subjects' clinical samples.
Danish: EMA's gennemgang skete efter en FDA-inspektion1, hvor man fandt flere problemer på Semlers bioanalytiske enhed, herunder erstatning af og manipulation med forsøgspersoners kliniske prøver.
English: It also included ongoing marketing authorisation applications for medicines which use study data from these sites.
Danish: EMA har også set på igangværende ansøgninger om markedsføringstilladelse for lægemidler, der understøttes af data fra disse enheder.
English: Bioequivalence studies usually form the basis for approval of generic medicines.
Danish: Bioækvivalensundersøgelser udgør normalt grundlaget for godkendelse af generiske lægemidler.
English: • A number of medicines for use in the EU rely on studies carried out at the Semler site in India.
Danish: • En række lægemidler til brug i EU godkendes på grundlag af undersøgelser, der udføres hos Semler i Indien.
English: Bioequivalence studies performed at the site cannot be used to support medicines approval in the EU
Danish: Bioækvivalensundersøgelser, der er udført hos Semler, kan ikke anvendes til at understøtte godkendelse af lægemidler i EU
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom22 September 2016 EMA/633693/2016
Danish: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom22.