FrancophonIA/ELRC3.0 huggingface dataset:
English: Obtain 900 ± 200 MBq of freshly eluted 99mTc sodium pertechnetate eluate from any commercial source which has been eluted within the past 24 hours.
Danish: Tag 900 ± 200 MBq frisk elueret natriumperteknetat 99mTc eluat fra en kommercielt tilgængelig generator, som er blevet elueret inden for de sidste 24 timer.
English: • If you know that you are allergic (hypersensitive) to sulesomab or any protein which comes from a mouse, tell your doctor.
Danish: • hvis du er overfølsom (allergisk) over for proteiner, der stammer fra mus eller et af de øvrige indholdsstoffer.
English: SPECIAL STORAGE CONDITIONS Store in a refrigerator (2ºC-8ºC).
Danish: SÆRLIGE OPBEVARINGSBETINGELSER Opbevares i køleskab (2-8 °C).
English: LeukoScan is an antibody fragment which is linked to a radioactive substance called technetium.
Danish: LeukoScan er et antistoffragment, som er kædet sammen med et radioaktivt stof - technicium.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Kit for the preparation of 99mTc-labelled LeukoScan.
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Præparationssæt til fremstilling af 99mTc-mærket LeukoScan.
English: The maximum amount of LeukoScan [99mTc] that can be administered safely has not been determined.
Danish: Den maksimale sikre mængde af LeukoScan [99mTc], er ikke blevet fastsat.
English: LeukoScan is not expected to bind to leukocytes in patients with paroxysmal nocturnal hemoglobinuria.
Danish: LeukoScan forventes ikke at binde til leukocytter i patienter med paroxysmal natlig hæmoglobinuri.
English: In a subgroup of patients in whom LeukoScan was compared directly to the currently available 111Inlabelled (occasionally 99mTc-labelled) autologous white blood cell (WBC) scanning test, LeukoScan showed a statistically significant increase in sensitivity over that achieved by WBC scanning (87.7% vs. 72.6%, p = 0.003 by McNemar's Test), with no discernible decrease in specificity as compared to WBC
Danish: I en gruppe af patienter, i hvilken LeukoScan blev sammenlignet direkte med denfor tiden anvendte 111Inmærkede (lejlighedsvis 99mTc-mærket) autologe leukocyttest (hvide blodlegemer),viste LeukoScan en statistisk signifikant bedring i sensitivitet i forhold til den,der blev opnået med leukocytscanning (87,7 % mod 72,6%, p = 0,003 med McNemar's test) med intet tydeligt fald i specificitet i sammenligning med
English: LeukoScan is not recommended for use in children.
Danish: LeukoScan bør ikke anvendes til børn.
English: This suggests that imaging can be accomplished anytime between one and eight hours after injection (at the convenience of the nuclear
Danish: Dette viser at billedoptagelse kan foretages på et hvilket som helst tidspunkt mellem 1 og 8 timer efter indsprøjtning (til fordel både for den nuklearmedicinske afdeling og patienten).
English: Clean the rubber closure of each vial such as with an alcohol wipe.
Danish: Aftør gummiproppen på hvert hætteglas med en alkoholvædet klud.
English: C. SPECIFIC OBLIGATIONS TO BE FULFILLED BY THE MARKETING
Danish: C. SÆRLIGE FORPLIGTELSER, SOM SKAL OPFYLDES AF INDEHAVEREN AF
English: Name and address of the manufacturer(s) of the biological active substance(s) Immunomedics, Inc.
Danish: FREMSTILLER(E) ANSVARLIG(E) FOR BATCHFRIGIVELSE Navn og adresse på fremstilleren (fremstillerne) af det (de) biologisk aktive stof(fer) Immunomedics, Inc.
English: When a bone scan is negative, imaging with LeukoScan may rarely show a positive response and this may indicate early osteomyelitis.
Danish: Når en knoglescanning er negativ, kan undersøgelsen med LeukoScan i sjældne tilfælde give et positivt svar, og dette kan indikere osteomyelitis.
English: The recommended adult dose is 0.25 mg of Fab′ fragment labelled with 900 ± 200 MBq of technetium 99mTc pertechnetate (approximately 1.2 ml).
Danish: Den anbefalede voksendosis er 0,25 mg af Fab' fragment, der er mærket med 900 ± 200 MBq af technicium 99mTc perteknetat (ca. 1,2 ml).
English: No studies effects of food/drink have been performed.
Danish: Der er ikke udført studier vedrørende føde-og drikkevarers indflydelse på effekten.
English: Radiopharmaceuticals should be prepared by the user in a manner which satisfies both radiation safety and pharmaceutical quality requirements.
Danish: Radioaktive lægemidler skal præpareres af brugeren på en måde, der både tilfredsstiller kravene til strålebeskyttelse og lægemiddelkvalitet.
English: Pack size: one vial per carton container.
Danish: Pakningsstørrelse: Et hætteglas pr. karton.
English: Following reconstitution, unused radiopharmaceutical and vial should be handled as radioactive waste and disposed of in accordance with local requirements.
Danish: Efter rekonstitution skal ubrugte radiofarmaka og hætteglas behandles som radioaktivt affald og bortskaffes i henhold til lokale forordninger.
English: In clinical trials, single doses of 1.0 mg of LeukoScan radiolabelled with 900 ± 200 MBq of 99mTc were administered to 11 patients with various types of infection and there were no adverse reactions at this
Danish: I kliniske afprøvninger er enkeltdoser på 1.0 mg af LeukoScan mærket med 900 ± 200 MBq 99 m Tc blevet givet til 11 patienter med forskellige typer infektion og der var ingen bivirkninger ved denne dosis.
English: Each 3 ml vial contains 0.31 mg sulesomab (IMMU-MN3 murine Fab′-SH antigranulocyte monoclonal
Danish: Hvert 3 ml hætteglas indeholder 0,31 mg sulesomab (IMMU-MN3-murinus Fab' SH antigranulocyt
English: Rehydrate with sterile, non-pyrogenic 99mTc Na pertechnetate.
Danish: Hydratiseres igen med sterilt ikke-pyrogent 99mTc natriumperteknetat.
English: • Radiopharmaceuticals should be prepared by the user in a manner which satisfies both radiation safety and pharmaceutical quality requirements.
Danish: • Radiofarmaka skal præpareres af brugeren på en måde, således at kravene angående strålingssikkerhed og lægemidlets kvalitet overholdes.
English: LeukoScan has not been employed to diagnose osteomyelitis in patients with sickle cell anaemia.
Danish: LeukoScan er ikke blevet brugt til diagnosticering af osteomyelitis hos patienter med seglcelleanæmi.
English: The doctor does this by using a special imaging camera that reveals areas of radioactivity to see where the infections are located.
Danish: Lægen anvender hertil et specielt kamera, som afbilder områder med radioaktivitet.
English: Lactation
Danish: Overdosering
English: 0.25 mg of LeukoScan will be labelled with 740-1110 MBq of technetium.
Danish: LeukoScan vil blive mærket med 740-1110 MBq technicium.
English: No induction of human anti-mouse antibody (HAMA) reactive with fragment was observed in any
Danish: Der er ikke observeret induktion af human antimus antistof (HAMA) overfor fragmenter i nogen
English: The clinical results indicate that among different presentations of osteomyelitis, LeukoScan can show different results.
Danish: De kliniske resultater viser, at Leucoscan kan give forskellige resultater blandt forskellige former for osteomyelitis .
English: The imaging agent, technetium-99m LeukoScan [technetium-99m sulesomab] is formed by reconstitution of the contents of the LeukoScan vial with 0.5 mL sodium chloride for injection followed by the addition of 1100 MBq of sodium pertechnetate [99mTc] in 1 mL of Sodium Chloride for Injection.
Danish: Billedbehandlingskomponenten technetium-99m LeukoScan [technetium-99m sulesomab] fremstilles ved rekonstituering af indholdet i LeukoScan-hætteglasset med 0,5 ml natriumkloridinjerktionsvæske efterfulgt af tilsætning af 1100 MBq natriumperteknetat [99mTc] i 1 ml natriumkloridinjektionsvæske.
English: The kit does not include the radioisotope.
Danish: Radioisotopen er ikke inkluderet i dette kit.
English: Hydrochloric Acid (Trace) Sodium Potassium Tartrate, Tetrahydrate Sodium Acetate, Trihydrate
Danish: Natriumklorid Saltsyre (spor) Natriumacetat, trihydrat
English: • This radiopharmaceutical may be received, used and administered only by authorised persons in designated clinical settings.
Danish: • Dette radiofarmakon må kun modtages, anvendes og administreres af autoriseret personale i specielt angivne kliniske områder.
English: After use, the container should be disposed of as radioactive waste.
Danish: Efter brug skal beholderen bortskaffes som radioaktivt affald.
English: This radiopharmaceutical may be received, used and administered only by authorised persons in designated clinical settings.
Danish: Dette radioaktive lægemiddel må kun modtages, anvendes og administreres af autoriseret personale i specielt indrettede kliniske områder.
English: For this medicinal product, the effective dose equivalent resulting from an administered activity of 750 MBq is typically 7.7 mSv for a 70 kg individual.
Danish: For dette lægemiddel er den effektive dosisækvivalent fra en administreret aktivitet på 750 MBq typisk
English: Shortly after mixing the LeukoScan with the radioactive technetium isotope, the doctor will inject it into your vein.
Danish: Kort efter tilsætningen af den radioaktive techniciumisotop til LeukoScan vil lægen indgive det i en af dine vener.
English: In the unlikely event of the administration of a radiation overdose with LeukoScan, the absorbed dose to the patient may be reduced by increased oral or intravenous intake of fluids to promote excretion of the
Danish: Hvis det usandsynlige skulle hænde, at en radioaktiv overdosis af LeukoScan er givet, kan den absorberede patientdosis reduceres ved at øge den orale eller intravenøse væskeindtagelse for at fremme
English: (77.5% vs. 75.8%, respectively).
Danish: Der er imidlertid en ækvivalent diagnostisk præcision for disse to former (77,5% mod 75,8% henholdsvis).
English: There was no doseresponse effect for imaging efficacy (sensitivity or specificity) over antibody doses ranging from 0.1 mg
Danish: Der var ingen dosisrespons indflydelse på undersøgelsens effektivitet (sensitivitet eller specificitet) for antistofdoser
English: Important information about some ingredients of LeukoScan If you have been told that you have an intolerance to some sugars, inform your doctor before you are
Danish: Vigtig information om nogle af de øvrige indholdsstoffer i LeukoScan Kontakt lægen, før De/du tager denne medicin, hvis lægen har fortalt Dem/dig, at De/du ikke tåler visse sukkerarter.
English: LeukoScan [99mTc] can be stored at room temperature after formulation.
Danish: LeukoScan [99mTc] kan opbevares ved stuetemperatur efter mærkning.
English: Immunomedics GmbH Otto-Röhm-Straße 69 D-64293 Darmstadt Germany
Danish: D-64293 Darmstadt
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS (VIAL LABEL)
Danish: MINDSTEKRAV TIL OPLYSNINGER, DER SKAL ANFØRES PÅ SMÅ INDRE EMBALLAGER
English: Kit for the preparation of 99mTc-labelled LeukoScan.
Danish: Præparationssæt til fremstilling af 99mTc-mærket LeukoScan.
English: LeukoScan is reconstituted with 0.5 ml isotonic sodium chloride injection.
Danish: LeukoScan opløses i 0,5 ml isotonisk natriumklorid injektionsvæske.
English: LeukoScan is used in patients with suspected infection of the bone called osteomyelitis.
Danish: LeukoScan anvendes til patienter med mulig betændelse i knoglen, kaldet osteomyelitis.
English: Each vial contains stannous chloride, sodium chloride, sodium potassium tartrate, sodium acetate, sucrose,
Danish: Hvert hætteglas indeholder stannoklorid, natriumklorid, natriumkaliumtartrat, natriumacetat, sakkarose,
English: However, in vitro granulocyte function tests did not show significant changes when the sulesomab was added.
Danish: In vitro granulocyt funktionstest viste imidlertid ingen signifikant forskel
English: 6.2 Incompatibilities This medicinal product must not be mixed with other medicinal products except those mentioned in 6.6 or
Danish: Dette lægemiddel må ikke blandes med andre lægemidler end dem, der er anført under pkt.
English: Planar imaging in all views necessary to adequately visualise the affected area at 1-8 h post-injection with at least 500 k counts or ten minutes per view should be made.
Danish: Der bør 1-8 timer efter injektion tages billeder med mindst 500 k counts eller 10 minutter pr. optagelse i alle planer, der er nødvendige for tilstrækkelig visualisering af det angrebne område.
English: The estimated absorbed radiation doses to an average adult patient (70 kg) from an intravenous administration of LeukoScan labeled with 750 MBq of technetium-99m are provided in Table 1.
Danish: Den estimerede absorberede stråledosis til en gennemsnitlig voksen patient (70 kg) fra en intravenøs indgivelse af LeukoScan,der er mærket med 750 MBq technicium-99 m er givet i Tabel 1.
English: If you take more LeukoScan than you should
Danish: Hvis du har brugt for meget LeukoScan
English: Each 3 ml vial contains 0.31 mg sulesomab (IMMU-MN3 murine Fab′-SH antigranulocyte monoclonal antibody fragments) for the preparation of 99mTc labelled LeukoScan.
Danish: Hvert 3 ml hætteglas indeholder 0,31 mg sulesomab (IMMU-MN3-murinus Fab' SH antigranulocyt monoklonalt antistof fragmenter) til fremstilling af 99mTc-markeret LeukoScan.
English: No interactions with other medicines have been described to date.
Danish: Ingen påvirkninger er beskrevet til dato.
English: In the unlikely event of a radiation overdose being administered with LeukoScan [99mTc], the absorbed dose to the patient may be reduced by increased oral or intravenous intake of fluids to promote excretion
Danish: Skulle der mod forventning blive givet en overdosis af radioaktivitet i forbindelse med LeukoScan [99mTc], kan den absorberede dosis til patienten reduceres ved forøget oral eller intravenøs indtagelse af væske for at fremme udskillelse af det radioaktive stof.
English: After radiolabelling the antibody and diluting a 10 µl sample with 1.5 ml saline, immediately determine the radiochemical purity by Instant Thin Layer Chromatography on silica gel impregnated glass fiber strips, 1 × 9 cm using acetone as the solvent.
Danish: Efter mærkning af antistoffragmentet og fortynding af 10 μl prøven med 1,5 ml 0,9% natriumkloridopløsning, skal den radiokemiske renhed omgående bestemmes ved hjælp af hurtig tyndtlagskromatografi (Instant thin Layer Chromatography) på 1 x 9 cm glasfiberstrimler, der er imprægneret med silica-gel, idet man bruger acetone som udviklingsvæske.
English: Store in a refrigerator (2°C-8°C).
Danish: Skal opbevares i køleskab (2-8°C).
English: Summary of Normal Organ Dosimetry to an Average Adult Patient (70 kg) from an Intravenous Dose of LeukoScan Labelled with 750 MBq of Technetium-99m [Dose Estimate from 13 Subjects 26 Administrations]
Danish: Oversigt over normal organdosimetri for en gennemsnitlig voksen patient (70 kg) fra en intravenøs dosis af LeukoScan, der er mærket med 750 MBq technetium-99 m (Dosisoverslag fra 13 patienter, 26 indgivelser)
English: A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR
Danish: A. FREMSTILLER(E) AF DET (DE) BIOLOGISK AKTIVE STOF(FER) OG> FREMSTILLER(E) ANSVARLIG(E) FOR
English: INSTRUCTIONS FOR PREPARATION OF RADIOPHARMACEUTICALS Quality control
Danish: INSTRUKTIONER FOR FREMSTILLING AF RADIOAKTIVE LÆGEMIDLER
English: However, due to the low dose of protein administered and the short half-life of 99mTc, dosage adjustment is probably not
Danish: Som følge af den lille dosis af indgivet protein og den korte halveringstid for 99mTc-dosis, er justering sandsynligvis ikke Radioaktive lægemidler må kun bruges af kvalificeret personale med behørig offentlig tilladelse til brug
English: Kit - Store in a refrigerator (2ºC - 8ºC).
Danish: Kit: Skal opbevares i køleskab (2-8°C).
English: After injection, any remaining portion of the reconstituted solution should be discarded.
Danish: Hvis der er noget tilbage af opløsningen efter indsprøjtning skal den kasseres.
English: The following minor, self-limiting, rare adverse events were reported in the clinical trials and considered at least possibly related to LeukoScan: eosinophilia (3); and facial rash (1).
Danish: De følgende mindre, selvbegrænsende, sjældne bivirkninger er blevet rapporteret: eosinofili (3) udslæt i Ingen af disse blev anset for at være alvorlige, og alle blev løst uden følger.
English: The unreconstituted contents of the vial before radiolabelling are not to be directly administered to patients.
Danish: Hætteglassets urekonstituerede indhold før mærkning med 99m Tc må ikke gives direkte til patienterne.
English: NAME OF MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION LeukoScan 0.31 mg, powder for solution for injection 0.31 mg lyophilised sulesomab, stannous chloride and stabilizers.
Danish: LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E) LeukoScan 0,31 mg Pulver til injektionsvæske, opløsning 0,31 mg frysetørret stannoklorid og stabiliseringsmidler.
English: Date of approval of latest variation or transfer: MM/YYYY
Danish: Dato for godkendelse af sidste variation eller overførsel af markedsføringstilladelse:
English: 6.6 Special precautions for disposal and other handling Read complete directions thoroughly before starting the preparation procedure.
Danish: Læs hele brugsanvisningen grundigt igennem, før præparationsproceduren påbegyndes.
English: BEFORE YOU USE LEUKOSCAN You should not use LeukoScan 0.31 mg, sulesomab,powder for solution for injection
Danish: DET SKAL DU VIDE, FØR DU BEGYNDER BRUG AF LEUKOSCAN Brug ikke LeukoScan 0,31 mg, pulver til injektionsvæske, opløsning,
English: What LeukoScan looks like and contents of the pack
Danish: HVAD LEUKOSCAN ER OG HVAD DU SKAL BRUGE DET TIL
English: One vial prepared so as to contain 0.31 mg lyophilised LeukoScan monoclonal antibody fragment.
Danish: Et hætteglas, der indeholder 0,31 mg frysetørret LeukoScan monoklonalt antistoffragment.
English: 4.2 Posology and method of administration
Danish: 6.6 Regler for destruktion og anden håndtering
English: LeukoScan 0.31 mg, powder for solution for injection
Danish: LeukoScan 0,31 mg Pulver til injektionsvæske, opløsning
English: • Radiopharmaceutical agents should be used only by qualified personnel with appropriate government authorisation for the use and manipulation of radionuclides.
Danish: • Radiofarmaka må kun anvendes af kvalificeret personale med behørig statsanerkendelse angående
English: • If you have any further questions, please ask your doctor.
Danish: • Spørg lægen eller på apoteket, hvis der er mere, du vil vide.
English: Hypersensitivity
Danish: HÆTTEGLAS MÆRKESEDDEL
English: PACKAGE LEAFLET: INFORMATION FOR THE USER LeukoScan (0.31 powder for solution for injection) (sulesomab)
Danish: LeukoScan (0,31 pulver til injektionsvæske, opløsning) (sulesomab)
English: For a full list of excipients, see section 6.1.
Danish: For gentagen indgivelse se afsnit 4.4.
English: ATC code: VO4D At the concentrations and activities used for diagnostic procedures, LeukoScan does not appear to exert
Danish: I de koncentrationer og aktivitetsmængder der bruges til diagnostiske procedurer ser det ikke ud til at LeukoScan har nogen farmakodynamisk effekt.
English: Using saline injection, bring the final volume of eluate solution to 1.0 ml.
Danish: Volumen af eluatet justeres til 1,0 ml
English: B. CONDITIONS OF THE MARKETING AUTHORISATION • CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE IMPOSED ON THE
Danish: • BETINGELSER ELLER BEGRÆNSNINGER PÅLAGT INDEHAVEREN AF
English: NAME OF THE MEDICINAL PRODUCT LeukoScan 0.31 mg, powder for solution for injection
Danish: LÆGEMIDLETS NAVN LeukoScan 0,31 mg pulver til injektionsvæske, opløsning.
English: For reconstitution of lyophilised powder, with a sterile disposable syringe add 0.50 ml of saline injection into the shielded LeukoScan 3-ml vial.
Danish: Opløs det frysetørrede pulver i 0,50 ml 0,9% natriumklorid injektionsvæske i det blybeskyttede LeukoScan 3-ml hætteglas.
English: 4.7 Effects on ability to drive and use machines
Danish: 4.7 Virkninger på evnen til at føre motorkøretøj eller betjene maskiner Der er ikke blevet foretaget undersøgelser om indvirkninger på evnen til at føre motorkøretøj eller betjene maskiner.
English: Medicinal product subject to medical prescriptio
Danish: GENEREL KLASSIFIKATION FOR UDLEVERING Medicinsk produkt underkastet lovgivning om receptpligtige midler.
English: The effect on lymphocyte
Danish: Virkningen på lymfocytfunktionen er ikke blevet bestemt.
English: After mixing with Tc, the final product must be disposed of as radioactive waste in accordance with local law.
Danish: Destrueres som radioaktivt affald i overensstemmelse med lokal lovgivning.
English: • If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet,
Danish: • Tal med lægen eller apoteket, hvis en bivirkning bliver værre, eller du får bivirkninger, som ikke er
English: If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell
Danish: Tal med lægen eller apoteket, hvis en bivirkning bliver værre, eller du får bivirkninger, som ikke er nævnt her.
English: If either are present, the
Danish: Hvis en af disse tilstande er tilstede skal produktet kasseres.
English: The kit does not include the
Danish: Må ikke opbevares i
English: MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH
Danish: INDEHAVER AF MARKEDSFØRINGSTILLADELSEN Immunomedics GmbH
English: It was intended for use only when other antibiotics were not suitable.
Danish: Det skulle kun anvendes, når andre antibiotika ikke var egnede.
English: ‘Complicated' means that the infection is difficult to treat.
Danish: "Kompliceret" betyder, at infektionen er vanskelig at behandle.
English: Tigecycline Accord was expected to be used to treat adults and children older than 8 years with complicated infections of the skin and soft tissue (the tissue below the skin), except foot infections in people with diabetes.
Danish: Tigecycline Accord skulle anvendes til behandling af voksne og børn over 8 år med komplicerede infektioner i huden og det bløde væv (vævet under huden), med undtagelse af fodinfektioner hos personer med diabetes.
English: Because the medicine blocks the production of new proteins, the bacteria cannot multiply and they eventually die.
Danish: Når produktionen af nye proteiner blokeres, kan bakterierne ikke formere sig og vil til sidst dø.
English: The CHMP's main concern was lack of compliance with Good Manufacturing Practice (GMP) by the manufacturing site for the medicine's active substance.
Danish: CHMP's vigtigste betænkelighed var manglen på overholdelse af god fremstillingspraksis (Good Manufacturing Practice (GMP)) på stedet for fremstilling af det aktive stof i lægemidlet.
English: As for every medicine, the company also provided studies on the quality of Tigecycline Accord.
Danish: Som for alle lægemidler fremlagde virksomheden også undersøgelser af kvaliteten af Tigecycline Accord.
English: In its letter notifying the Agency of the withdrawal of the application, the company stated that it was withdrawing the medicine for marketing reasons because of the issues at the manufacturing site.
Danish: I sit brev til agenturet om tilbagetrækningen af ansøgningen anførte virksomheden, at den trak lægemidlet tilbage af markedsføringsmæssige årsager på grund af problemerne på fremstillingsstedet.
English: On 12 September 2017, Accord Healthcare Limited officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Tigecycline Accord, for the treatment of certain complicated infections.
Danish: Den 12. september 2017 meddelte Accord Healthcare Limited officielt Udvalget for Lægemidler til Mennesker (CHMP), at virksomheden ønsker at tilbagetrække sin ansøgning om markedsføringstilladelse for Tigecycline Accord til behandling af visse komplicerede infektioner.
English: Tigecycline Accord was developed as a ‘generic medicine'.
Danish: Tigecycline Accord er udviklet som et "generisk lægemiddel".
English: Studies on the benefits and risks of the active substance in the approved uses have already been carried out with the reference medicine, Tygacil, and did not need to be repeated for Tigecycline Accord.
Danish: Der er allerede gennemført undersøgelser af fordelene og risiciene ved det aktive stof i de godkendte anvendelser med referencelægemidlet, Tygacil, og det er ikke nødvendigt at gentage disse med Tigecycline Accord.