FrancophonIA/ELRC3.0 huggingface dataset:
English: The contents of the NeoSpect vial are not radioactive; however, after the addition of sodium pertechnetate (99mTc) solution for injection, adequate shielding of the final preparation must be
Danish: Indholdet af NeoSpect hætteglasset er ikke radioaktivt, men efter tilsætning af natriumpertechnetat (99mTc) injektionsvæske skal passende afskærmning af opløsningen opretholdes.
English: Immediately transfer the reaction vial to a lead safe in the boiling water bath, maintaining the vial in the upright position.
Danish: Overfør straks hætteglasset til en blybeholder i det kogende vandbad, hætteglasset skal forblive opretstående.
English: Using a shielded syringe, inject the required radioactivity of up to 1.8 GBq of sodium pertechnetate (99mTc) solution for injection, (diluted as appropriate with sodium chloride 0.9%
Danish: Ved brug af en skærmet sprøjte injicéres den ønskede mængde radioaktivitet op til 1,8 GBq af natriumpertechnetat (99mTc) injektionsvæske (passende fortyndet med natriumklorid 0,9% w/v injektionsvæske, opløsning til i alt 1 ml) i det afskærmede hætteglas.
English: 99mTc-depreotide binds to the extent of about 12% to plasma proteins in patients and healthy
Danish: Graden af plasma proteinbinding for 99mTc-depreotid er cirka 12% hos patienter og raske frivillige.
English: * nausea
Danish: * kvalme
English: NeoSpect is supplied in packs of 1 vial and 5 vials, each vial containing 47 micrograms depreotide.
Danish: NeoSpect kan fås i pakninger af 1 og 5 hætteglas, som hver indeholder 47 mikrogram depreotid.
English: NeoSpect is used for preparation of technetium (99mTc) depreotide solution for injection.
Danish: NeoSpect anvendes til fremstilling af technetium (99mTc) depreotid injektionsvæske, opløsning.
English: When a solution of the radioactive substance sodium pertechnetate (99mTc) is added to the vial, 99mTc-depreotide is formed.
Danish: Når en opløsning af den radioaktive substans natriumpertechnetat (99mTc) tilsættes hætteglasset, dannes 99mTc-depreotid.
English: Assay the total radioactivity, complete the user radiation label and attach it to the lead shielded vial.
Danish: Mål den totale radioaktivitet, udfyld bruger strålingsetiketten og anbring den på
English: 1) Saturated sodium chloride solution (SSCS)
Danish: 1) Mættet natriumklorid opløsning (MNO)
English: below) 1:1 (v/v) methanol / 1M ammonium acetate (MAM)2 (2 See section 2.)
Danish: Mættet natriumklorid opløsning (MNO)1 (Se afsnit 1. nedenfor) 1:1 (v/v) metanol / 1M ammonium acetat (MAM)2 (Se afsnit 2. nedenfor)
English: NAME OF THE MEDICINAL PRODUCT NeoSpect 47 micrograms, kit for radiopharmaceutical preparation.
Danish: LÆGEMIDLETS NAVN NeoSpect 47 mikrogram, radiofarmaceutisk præparationssæt.
English: An assay of the radiochemical purity of the prepared injection can be performed using the following
Danish: En undersøgelse af den strålingskemiske renhed af den færdigblandede injektionsvæske kan udføres
English: The use of NeoSpect does involve exposure to small amounts of radioactivity, however your doctor will always consider the possible risks and benefits when considering the use of this product.
Danish: Din læge vil altid overveje mulige fordele og ulemper ved anvendelsen af dette produkt.
English: Sodium pertechnetate (99mTc) solution for injection containing oxidants ought not to be used for the
Danish: Natriumpertechnetat (99mTc) injektionsvæske som indeholder oxidanter, bør ikke anvendes til tilberedning af det
English: Pour the MAM and SSCS into separate developing tanks to a depth of approximately 0.5 cm. Cover the tanks and allow to equilibrate with the solvent vapours.
Danish: Hæld MAM og MNO i hvert sit udviklingskar til en dybde på ca. 0,5 cm. Tildæk karrene og
English: Each vial contains: 47 micrograms depreotide as depreotide trifluoroacetate
Danish: Hvert hætteglas indeholder: 47 mikrogram depreotid som depreotidtrifluoroacetat
English: To minimise the dose of radiation absorbed by the bladder, the intake of fluids should be increased during the first few hours after injection to permit frequent voiding.
Danish: For at mindske stråledosis til urinblæren, skal man drikke rigeligt i de første timer efter indsprøjtningen for at sikre hyppig vandladning.
English: Sodium pertechnetate (99mTc) solution for injection (Ph.Eur) is used for reconstitution.
Danish: Natriumpertechnetat (99mTc) injektionsvæske (Ph.Eur) anvendes til rekonstitution.
English: The corresponding negative predictive value and positive predictive value for NeoSpect in association with chest X-ray were 96-98% and 6178% respectively.
Danish: De tilsvarende NPV og PPV for NeoSpect i forbindelse med thorax røntgen var henholdsvis 96-98% og 61-78%.
English: To be reconstituted with sodium pertechnetate (99mTc) solution for injection (not included in this kit).
Danish: Skal rekonstitueres med natriumpertechnetat (99mTc) injektionsvæske (ikke inkluderet i dette
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
Danish: NAVN OG ADRESSE PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN CIS bio international
English: The contents of NeoSpect are intended only for use in the preparation of 99mTc-depreotide solution for injection (see section 12).
Danish: 4.4 Særlige advarsler og forsigtighedsregler vedrørende brugen Indholdet af NeoSpect er udelukkende beregnet til fremstilling af 99mTc-depreotid injektionsvæske, opløsning (se punkt 12).
English: When it is necessary to administer radioactive medicinal products to women of childbearing potential,
Danish: (Se punkt 4.3) Når det er nødvendigt at administrere radioaktive lægemidler til kvinder i den fødedygtige alder, skal information om eventuel graviditet altid indhentes.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION NeoSpect 47 micrograms, kit for radiopharmaceutical preparation Depreotide
Danish: LÆGEMIDLETS NAVN, STYRKE OG/ELLER INDGIVELSESVEJ(E) NeoSpect 47 mikrogram, radiofarmaceutisk præparationssæt Depreotid
English: History of hypersensitivity reaction to depreotide, any of the excipients of NeoSpect or sodium pertechnetate (99mTc) solution for injection.
Danish: Overfølsomhed over for depreotid eller over for et eller flere af hjælpestofferne i NeoSpect eller natriumpertechnetat (99mTc) injektionsvæske.
English: Store the reconstituted solution for injection upright at 15 °C - 25 °C and use within 5 hours of
Danish: Opbevar den fremstillede injektionsvæske, opløsning opretstående ved 15°C - 25°C og anvend
English: * fatigue
Danish: * træthed
English: 1:1 Methanol / 1M Ammonium Acetate (MAM) - Carefully mix one part methanol with one part 1M Ammonium Acetate.
Danish: Bland forsigtigt én del metanol med én del 1M ammonium acetat.
English: It is not known whether 99mTc-depreotide is excreted in human milk, 99mTc-depreotide is therefore contraindicated during lactation.
Danish: Det vides ikke, hvorvidt 99mTc-depreotid udskilles i human brystmælk.
English: 5 vials, each vial containing 47 micrograms of depreotide.
Danish: 5 hætteglas, hvert hætteglas indeholder 47 mikrogram depreotid
English: After labelling with the radioactive sodium pertechnetate (99mTc) solution for injection, radiolabelled NeoSpect will be injected
Danish: Efter mærkningen med det radioaktive natriumpertechnetat (99mTc) injektionsvæske, opløsning injicéres radioaktivt mærket
English: After reconstitution with sodium pertechnetate (99mTc) solution for injection, 99mTc-depreotide is
Danish: Efter rekonstitution med natriumpertechnetat (99mTc) injektionsvæske, dannes 99mTc-depreotid.
English: The volume of diluted sodium pertechnetate (99mTc) solution for injection, added to the vial
Danish: Mængden af den fortyndede natriumpertechnetat (99mTc) injektionsvæske som tilføjes
English: NAME OF THE MEDICINAL PRODUCT NeoSpect 47 micrograms, kit for radiopharmaceutical preparation Depreotide
Danish: NeoSpect 47 mikrogram, radiofarmaceutisk præparationssæt Depreotid
English: The product is filled in 5 ml type I glass vials.
Danish: Produktet er fyldt på 5 ml hætteglas, type I. Hætteglassene er lukket med butylgummi propper og forseglet med aluminiumslåg.
English: The recommended dosage is one vial (approximately 47 micrograms of depreotide) labelled with
Danish: Den anbefalede dosis er et hætteglas (cirka 47 mikrogram depreotid) mærket med 555 - 740 MBq
English: 2) 1:1 Methanol / 1M Ammonium Acetate (MAM) 1M Ammonium Acetate - Add 3.9 ± 0.1 grams of solid ammonium acetate to a 50 ml volumetric flask.
Danish: Tilsæt 3,9 ± 0,1 gram af fast ammonium acetat til et 50 ml målekolbe.
English: 99mTc-depreotide is indicated for single use only.
Danish: Gentagen administration 99mTc-depreotid er kun til enkelt administration.
English: The recommended dosage is approximately 47 micrograms depreotide (one vial) labelled with
Danish: Den anbefalede dosis er cirka 47 mikrogram depreotid (et hætteglas) mærket med 555 - 740 MBq
English: * vomiting
Danish: * opkastning
English: Lactation
Danish: Amning
English: * dizziness
Danish: * svimmelhed
English: Taking other medicines
Danish: LÆGEMIDLETS NAVN
English: - if you are suffering from diabetes or other related conditions - if you have a renal disease - if you have a liver disease
Danish: Vær særlig forsigtig med at anvende NeoSpect: - Hvis du lider af sukkersyge eller andre lignende sygdomme.
English: Reconstitute with sodium pertechnetate (99mTc) injection
Danish: Opløs i natriumpertechnetat (99mTc) injektionsvæske
English: Thyroid gland Bone marrow Liver
Danish: Skjoldbruskkirtlen Knoglemarv Lever
English: Kit for radiopharmaceutical preparation Depreotide
Danish: Radiofarmaceutisk præparationssæt
English: Reconstitute with sodium pertechnetate (99mTc) injection.
Danish: Opløs i natriumpertechnetat (99mTc) injektionsvæske.
English: Kidneys Spleen
Danish: Nyrer
English: You should not do both.
Danish: Du må ikke gøre begge dele.
English: • are over 75 years of age
Danish: • hvis du er ældre end 75 år
English: It is especially important to tell your doctor if you take:
Danish: Det er især vigtigt at fortælle lægen, hvis du tager:
English: Date of first authorisation:19 January 2015
Danish: Dato for første markedsføringstilladelse: 19. januar 2015
English: Your doctor will decide if this medicine is appropriate for you.
Danish: Lægen vil beslutte, om dette lægemiddel er passende for dig.
English: Do not take Zontivity if any of the above apply to you.
Danish: Tag ikke Zontivity, hvis noget af ovenstående gælder for dig.
English: DATE OF THE REVISION OF THE TEXT
Danish: DATO FOR ÆNDRING AF TEKSTEN
English: • Do not take a double-dose (two doses at the same time) to make up for a forgotten dose.
Danish: • Du må ikke tage en dobbeltdosis (to doser på samme tid) som erstatning for den glemte dosis.
English: It is not known if Zontivity will harm your unborn baby.
Danish: Det er ukendt, om Zontivity kan skade dit ufødte barn.
English: • If you forget a dose, take it as soon as you remember.
Danish: • Hvis du har glemt at tage en dosis, så tag den så snart du kommer i tanke om det.
English: The clinical significance of this finding is currently unknown.
Danish: Den kliniske betydning af dette fund kendes ikke på nuværende tidspunkt.
English: Adverse reactions are classified according to frequency and System Organ Class.
Danish: Bivirkningerne er inddelt i henhold til hyppighed og systemorganklasse.
English: Patients with low body weight (<60 kg)
Danish: Patienter med lav legemsvægt (<60 kg)
English: • pink, red, or brown urine
Danish: • lyserød, rød eller brun urin
English: * K-M estimate at 1,080 days
Danish: * K-M-estimat efter 1.080 dage
English: In general, a body weight <60 kg is a risk factor for bleeding.
Danish: Generelt er en legemsvægt på <60 kg en risikofaktor for blødning.
English: • sudden numbness or weakness of your arm, leg or face, especially if only on one side of the body
Danish: • pludseligt opstået følelsesløshed eller slaphed i armen, benet eller ansigtet, især hvis det kun er i den ene side af kroppen
English: Common: may affect up to 1 in 10 people
Danish: Almindelig: kan forekomme hos op til 1 ud af 10 personer
English: Treatment of presumed overdose should address signs and symptoms.
Danish: Ved formodet overdosering behandles tegn og symptomer.
English: Patients receiving digoxin should be monitored as clinically indicated.
Danish: Patienter, der får digoxin, skal monitoreres som klinisk indiceret.
English: Randomization to 18 months
Danish: Randomisering til 18 måneder
English: The recommended dose is one tablet by mouth each day taken with or without food.
Danish: Den anbefalede dosis er en tablet, der skal tages gennem munden hver dag med eller uden mad.
English: Table 3: CABG-Related Bleeds
Danish: Tabel 3: CABG-relaterede blødninger
English: These differences are not considered to be clinically relevant and no dose adjustment is necessary.
Danish: Disse forskelle anses ikke for at være klinisk relevante, og dosisjustering er ikke nødvendig.
English: Medicinal products that increase gastric pH
Danish: Lægemidler, der øger gastrisk pH
English: • Take Zontivity on a regular basis and for as long as your doctor keeps prescribing it.
Danish: • Tag Zontivity regelmæssigt, så længe din læge fortsat ordinerer det.
English: Know the medicines you take.
Danish: Hold styr på al den medicin, du tager.
English: Steady-state is achieved by 21 days following once-daily dosing.
Danish: Steady-state opnås 21 dage efter dosering en gang dagligt.
English: If Zontivity must be temporarily discontinued, restart it as soon as possible.
Danish: Hvis det er nødvendigt at seponere Zontivity midlertidigt, skal behandlingen genoptages så hurtigt som muligt.
English: Your doctor will determine if you should take Zontivity for more than 24 months.
Danish: Din læge vil beslutte, om du skal tage Zontivity i mere end 24 måneder.
English: • Do not stop taking Zontivity without first talking to the doctor who prescribed it for you.
Danish: • Du må ikke holde op med at tage Zontivity uden først at have talt med den læge, som har ordineret lægemidlet til dig.
English: Zontivity is used to lower your chance of:
Danish: Zontivity anvendes til at nedsætte risikoen for, at du:
English: There is less information about other types of surgery but the overall evidence does not suggest an excessive risk of major bleeding.
Danish: Der er færre oplysninger om andre operationstyper, men den samlede evidens tyder ikke på en usædvanlig stor risiko for større blødning.
English: Zontivity may be taken with or without food.
Danish: Zontivity kan indtages med eller uden mad.
English: Interruption of Zontivity treatment should be avoided.
Danish: Afbrydelse af behandlingen med Zontivity bør undgås.
English: BLISTER - unit dose
Danish: BLISTER - enhedsdosis
English: Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); not known (cannot be estimated from the available data).
Danish: Hyppigheden er angivet som: Meget almindelig (≥1/10); Almindelig (≥1/100 til <1/10); Ikke almindelig (≥1/1.000 til <1/100); Sjælden (≥1/10.000 til <1/1.000); Meget sjælden (<1/10.000); Ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: CYP2C8 substrates
Danish: CYP2C8-substrater
English: It may take at least 7 days for Zontivity to start working.
Danish: Det kan tage mindst 7 dage, før Zontivity begynder at virke.
English: Zontivity is indicated for the reduction of atherothrombotic events in adult patients with
Danish: Zontivity er indiceret til reduktion af aterotrombotiske hændelser hos voksne patienter med
English: The mean volume of distribution of vorapaxar is approximately 424 litres.
Danish: Det gennemsnitlige fordelingsvolumen for vorapaxar er cirka 424 liter.
English: • if you are allergic to vorapaxar sulfate or any of the other ingredients of this medicine (listed in section 6)
Danish: • hvis du er allergisk over for vorapaxarsulfat eller et af de øvrige indholdsstoffer i dette lægemiddel (angivet i punkt 6)
English: Severe bleeding is uncommon, but can be life threatening.
Danish: Kraftig blødning er sjælden, men kan være livstruende.
English: • dying from a heart attack
Danish: • dør som følge af et hjerteanfald
English: There are limited data on the efficacy and safety of Zontivity beyond 24 months.
Danish: Der er begrænsede data vedrørende Zontivitys virkning og sikkerhed ud over 24 måneder.
English: Uncommon: may affect up to 1 in 100 people
Danish: Ikke almindelig: kan forekomme hos op til 1 ud af 100 personer
English: • have a bodyweight of less than 60 kg
Danish: • hvis du vejer mindre end 60 kg
English: Zontivity should be used during pregnancy only if the potential benefit to the mother justifies the potential risk to the foetus.
Danish: Zontivity må kun anvendes under graviditet, hvis den potentielle fordel for moderen opvejer den potentielle risiko for fostret.
English: Within that period the effect was similar regardless of the time from qualifying MI to the start of therapy with Zontivity.
Danish: Inden for denne periode var virkningen sammenlignelig uanset tiden fra det kvalificerende MI til initiering af behandlingen med Zontivity.
English: • suddenly feeling dizzy or sudden severe headache with no known cause
Danish: • pludseligt opstået svimmelhed eller pludseligt opstået kraftig hovedpine uden kendt årsag
English: • needing an urgent operation to open blocked arteries in the heart.
Danish: • får behov for akut operation for at åbne tilstoppede pulsårer i hjertet.
English: Do not take Zontivity:
Danish: Tag ikke Zontivity:
English: Tell all of your doctors and dentists that you are taking Zontivity.
Danish: Fortæl det til alle dine læger og tandlæger, at du tager Zontivity.
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, genotoxicity, carcinogenic potential, and fertility.
Danish: Prækliniske data afslører ingen speciel risiko for mennesker vurderet ud fra konventionelle studier af sikkerhedsfarmakologi, genotoksicitet, karcinogent potentiale og fertilitet.
English: • vomiting blood or your vomit looks like ‘coffee grounds'
Danish: • opkastning af blod, eller dit opkast ligner ”kaffegrums”
English: Ask your doctor or pharmacist if you are not sure if your medicine is listed above.
Danish: Spørg din læge eller apotekspersonalet, hvis du ikke er sikker på, at din medicin er anført ovenfor.
English: The apparent terminal half-life for vorapaxar is 187 hours (range 115-317 hours) and is similar for the active metabolite.
Danish: Den tilsyneladende terminale halveringstid for vorapaxar er 187 timer (interval: 115-317 timer) og er tilsvarende for den aktive metabolit.
English: • bleeding from cuts or wounds that is more than normal
Danish: • blødning fra skrammer eller sår, der er kraftigere end normalt
English: • sudden difficulty in walking or loss of balance or co-ordination
Danish: • pludseligt opstået gangbesvær, tab af balance eller koordinationsevne
English: In these subgroups, Zontivity should only be prescribed after careful assessment of individual potential risks and benefits and the need for co-medication that may further increase the risk of bleeding.
Danish: I disse undergrupper må Zontivity kun ordineres efter en nøje vurdering af de individuelle potentielle risici og fordele samt behovet for samtidig anvendelse af medicin, som kan øge risikoen for blødning yderligere.
English: Method of administration Oral use.
Danish: Administration Oral anvendelse.
English: Vorapaxar did not increase bleeding time in non-human primates when administered alone at 1 mg/kg.
Danish: Vorapaxar øgede ikke blødningstiden hos non-humane primater, når det blev administreret alene ved 1 mg/kg.
English: Zontivity may affect the way other medicines work, and other medicines may affect how Zontivity works.
Danish: Zontivity kan påvirke virkningen af anden medicin, og anden medicin kan måske påvirke virkningen af Zontivity.
English: The systemic exposure of M20 is ~20% of the exposure to vorapaxar.
Danish: Den systemiske eksponering for M20 er ~20% af eksponeringen for vorapaxar.
English: Therefore, Zontivity should be used with caution in such patients.
Danish: Derfor skal Zontivity anvendes med forsigtighed hos disse patienter.
English: Patients with only one Event Patients with two Events Patients with ≥3 Events
Danish: Patienter med kun en hændelse Patienter med to hændelser Patienter med ≥3 hændelser
English: • red or black stools (looks like tar)
Danish: • rød eller sort afføring (ligner tjære)
English: Randomization to 12 months Total Events
Danish: Randomisering til 12 måneder Hændelser i alt
English: Bleeding time was prolonged slightly with administration of acetylsalicylic acid alone or in combination with vorapaxar.
Danish: Blødningstiden blev forlænget marginalt ved administration af acetylsalicylsyre alene eller i kombination med vorapaxar.
English: No dosage adjustment of digoxin or Zontivity is recommended.
Danish: Dosisjustering af digoxin eller Zontivity frarådes.
English: The primary route of elimination is through the faeces, with approximately 91.5% of radiolabeled dose predicted to be recovered in the faeces compared to 8.5% in the urine.
Danish: Den primære eliminationsvej er gennem fæces, og cirka 91,5% af den radioaktivt mærkede dosis forventes at blive genfundet i fæces sammenlignet med 8,5% i urinen.
English: • The active substance is vorapaxar sulfate.
Danish: • Aktivt stof: vorapaxarsulfat.
English: Phospholipidosis occurs at acceptable human to animal safety margins and was reversible.
Danish: Fosfolipidose forekommer ved en acceptabel sikkerhedsmargin for forskellen mellem mennesker og dyr og er reversibel.
English: Vorapaxar is eliminated primarily by metabolism, with significant contribution by CYP3A.
Danish: Vorapaxar elimineres overvejende gennem metabolisering med signifikant bidrag fra CYP3A.
English: Studies in rats have shown vorapaxar and/or its metabolites are excreted in milk.
Danish: Studier med rotter har vist, at vorapaxar og/eller dets metabolitter udskilles i mælk.
English: A patient who misses a dose of Zontivity should skip the missed dose if it is within 12 hours of the next scheduled dose and take the next dose at the regular scheduled time.
Danish: En patient, der glemmer at tage en dosis af Zontivity, skal springe den glemte dosis over, hvis der er mindre end 12 timer til den næste planlagte dosis, og skal tage den næste dosis på det planlagte tidspunkt.
English: Zontivity is used in adults who have had a heart attack or have a condition known as "peripheral arterial disease" (also known as poor circulation in the legs).
Danish: Zontivity anvendes til voksne, som har haft et hjerteanfald eller som har en lidelse, der kaldes "perifer arteriesygdom" (også kaldet dårligt blodomløb i benene).
English: However, if it is within 12 hours of the next dose, skip the missed dose.
Danish: Hvis der er mindre end 12 timer til den næste dosis, så spring den glemte dosis over.
English: The most common adverse reaction reported during treatment is bleeding.
Danish: Den hyppigst rapporterede bivirkning under behandling er blødning.
English: Hazard Ratio is vorapaxar group versus placebo group.
Danish: Hazard Ratio er vorapaxar-gruppen versus placebo-gruppen.
English: The safety and efficacy of Zontivity in children aged less than 18 years have not yet been established.
Danish: Zontivitys sikkerhed og virkning hos børn under 18 år er endnu ikke klarlagt.
English: Zontivity should be used with caution in patients with a body weight <60 kg.
Danish: Zontivity skal anvendes med forsigtighed hos patienter med en legemsvægt på <60 kg.
English: The recommended dose of Zontivity is 2.08 mg to be taken once daily.
Danish: Den anbefalede dosis af Zontivity er 2,08 mg en gang dagligt.
English: Rates were similar for Zontivity and placebo.
Danish: Andelen var den samme for Zontivity og placebo.
English: Zontivity increases the risk of bleeding in proportion to the patient's underlying bleeding risk.
Danish: Zontivity øger risikoen for blødning i forhold til patientens underliggende blødningsrisiko.
English: In post-MI and PAD patients, the median duration of treatment with Zontivity in these patients was 2.5 years (up to 4 years).
Danish: Hos post-MI- og PAD-patienter var den gennemsnitlige behandlingsvarighed med Zontivity 2,5 år (op til 4 år).