FrancophonIA/ELRC3.0 huggingface dataset:
English: The administration of radiopharmaceuticals creates risks for other persons from external radiation or contamination from spills of urine, vomiting, blood, etc.
Danish: Ved administration af radioaktive lægemidler udsættes andre personer for risiko for ekstern bestråling eller kontaminering fra spild af urin, opkast, blod osv. Der skal derfor træffes forholdsregler til beskyttelse mod stråling i overensstemmelse med nationale bestemmelser.
English: Radiolabelling of carrier molecules with gallium (68Ga) chloride is very sensitive to the presence of trace metal impurities.
Danish: Radioaktiv mærkning af bærermolekyler med gallium (68Ga)-chlorid er meget følsom for tilstedeværelse af spormetalurenheder.
English: Set the temperature of the shielded dry bath at 95°C and wait for the temperature to reach the set point and stabilize.
Danish: Indstil temperaturen på det afskærmede tørbad til 95 °C og vent på, at temperaturen når indstillingsværdien og stabiliserer sig.
English: • Glass-fibre ITLC paper (e.g. Agilent ITLC SGI001) pre-cut to 1 cm x 12 cm strips
Danish: • Glasfiber ITLC-papir (fx Agilent ITLC SGI001) udskåret i strimler på 1 cm x 12 cm
English: With a 5 mL sterile syringe and a sterile needle (coated with silicone or other appropriate material able to reduce metal impurity trace - not supplied) carefully withdraw 4 mL of water for injections (not supplied) and reconstitute the powder in Vial 1.
Danish: f. Med en 5ml steril sprøjte og en steril nål (coatet med silicone eller andet egnet materiale, der kan reducere spor af metalurenheder - medfølger ikke), trækkes forsigtigt 4 ml vand til injektionsvæsker (medfølger ikke) op. Rekonstituer pulveret i hætteglas 1. g. Tilsæt reaktionsbufferen tidligere doseret i den sterile 1 ml sprøjte.
English: If possible, for more convenience in the preparation of radiolabelled SomaKit TOC, the heating platform should be placed right beside the generator.
Danish: For at fremstille radioaktivt mærket SomaKit TOC mest praktisk bør opvarmningsenheden om muligt placeres lige ved siden af generatoren.
English: Interpretation of gallium (68Ga) edotreotide images and limitations of use PET images with gallium (68Ga) edotreotide reflect the presence of somatostatin receptors in the tissues.
Danish: Fortolkning af gallium (68Ga)-edotreotid-billeder og begrænsninger i anvendelsen PET-billeder med gallium (68Ga)-edotreotid afspejler tilstedeværelsen af somatostatin-receptorer i vævene.
English: d. Scan the ITLC with a radiometric ITLC scanner e. The retention factor (Rf) specifications are as follows: Not complexed gallium (68Ga) = 0 to 0.1 gallium (68Ga) edotreotide = 0.8 to 1
Danish: d. Scan ITLC-strimlen med en radiometrisk ITLC-scanner e. Retentionsfaktor (Rf)-specifikationerne er følgende: Ikke-kompleksbundet gallium (68Ga) = 0 til 0,1 Gallium (68Ga)-edotreotid = 0,8 til 1
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 40 micrograms
Danish: INDHOLD ANGIVET SOM VÆGT, VOLUMEN ELLER ANTAL DOSER 40 mikrogram
English: In the retrospective paper of Schreiter et al. 2014, the intra-individual comparison in a subgroup of 20 patients showed that gallium (68Ga) edotreotide permitted to localise the primary tumour in 9/20 (45%) patients while indium (111In) pentetreotide did in 2/20 (10%).
Danish: I den retrospektive rapport fra Schreiter et al. (2014) viste intra-individuel sammenligning i en undergruppe bestående af 20 patienter, at gallium (68Ga)-edotreotid tillod lokalisering af den primære tumor hos 9/20 patienter (45 %), mens indium (111In)-pentetreotid tillod lokalisering af den primære tumor hos
English: SomaKit TOC contains sodium
Danish: SomaKit TOC indeholder natrium
English: Gallium (68Ga) edotreotide solution is stable up to 4 hours after preparation.
Danish: Gallium (68Ga)-edotreotid-injektionsvæske er stabil i op til 4 timer efter fremstillingen.
English: The uptake in the liver and in the pituitary, thyroid and adrenal glands is lower.
Danish: Optagelsen i leveren, hypofysen, skjoldbruskkirtlen og binyrerne er lavere.
English: Each 40 microgram vial contains an excess of product.
Danish: Hvert 40 mikrogram hætteglas indeholder et overskud.
English: Thin layer chromatography (ITLC1, see details below)
Danish: Tyndtlagskromatografi (ITLC1, se yderligere oplysninger nedenfor)
English: For radiolabelling with gallium (68Ga) chloride solution.
Danish: Til radioaktiv mærkning med gallium (68Ga)-chloridopløsning.
English: However, after gallium (68Ga) chloride solution is added, adequate shielding of the final preparation must be maintained.
Danish: Når gallium (68Ga)-chloridopløsningen er tilsat, skal det færdige præparat derimod være tilstrækkelig afskærmet.
English: Organ uptake The organ with the highest physiological uptake of gallium (68Ga) edotreotide is the spleen, followed by the kidneys.
Danish: Organoptagelse Milten har den højeste fysiologiske optagelse af gallium (68Ga)-edotreotid, efterfulgt af nyrerne.
English: Use within 4 hours after radiolabelling.
Danish: Skal anvendes inden for 4 timer efter radioaktiv mærkning.
English: In the study of Kowalski et al. 2003 in 4 patients with GEP-NET, gallium (68Ga) edotreotide showed better patient-based detection rate (100%) than indium (111In) pentetreotide (50%).
Danish: I Kowalski et al. studiet (2003) med 4 patienter med GEP-NET viste gallium (68Ga)edotreotid en bedre patientbaseret detektionsrate (100 %) end indium (111In)-pentetreotid (50 %).
English: Finally remove the 0.2 µm sterile vent filter and move the vial to the hole of the dry bath at 95°C, using a plier.
Danish: Fjern til slut det 0,2 µm sterile ventilationsfilter og flyt hætteglasset til hullet i tørbadet ved 95 °C ved anvendelse af en tang.
English: In the study of Van Binnebeek et al. 2015 in 53 patients with metastatic GEP-NET [mostly GEP-NET (n=39) or NET of unknown origin (n=6)], the lesion-based detection rate of gallium (68Ga) edotreotide was 99.9% (1098/1099) versus 60% (660/1099) for indium (111In) pentetreotide based on the follow-up scans.
Danish: I Van Binnebeek et al. studiet (2015) med 53 patienter med metastatiske GEP-NET [hovedsageligt GEP-NET (n=39) eller NET af ukendt oprindelse (n=6)] var læsionsdetektionsraten for gallium (68Ga)-edotreotid 99,9 % (1.098/1.099) versus 60 % (660/1.099) for indium (111In)-pentetreotid, baseret på opfølgende scanninger.
English: The organs with high physiological uptake of gallium (68Ga) edotreotide include spleen, kidneys, liver, pituitary gland, thyroid gland and adrenals.
Danish: Organer med høj fysiologisk optagelse af gallium (68Ga)-edotreotid omfatter milt, nyrer, lever, hypofyse, skjoldbruskkirtel og binyrer.
English: The visual inspection should be performed under a shielded screen for radioprotection purposes.
Danish: Den visuelle inspektion skal udføres under en beskyttelsesafskærmning for at undgå radioaktiv stråling.
English: In the study of Buchmann et al. 2007, conducted in 27 patients mostly with GEP-NET (59%) or NETs of unknown primary (30%), gallium (68Ga) edotreotide identified 279 lesions versus 157 lesions seen with indium (111In) pentetreotide.
Danish: I Buchmann et al. studiet (2007) med 27 patienter hovedsageligt med GEP-NET (59 %) eller NET af ukendt primær oprindelse (30 %) identificerede gallium (68Ga)-edotreotid 279 læsioner versus indium (111In)-pentetreotid, der identificerede 157 læsioner.
English: The use of SomaKit TOC involves exposure to small amounts of radioactivity.
Danish: Når du får SomaKit TOC, bliver du udsat for små mængder radioaktivitet.
English: High physiological uptake of gallium (68Ga) edotreotide by the pancreas uncinate process can also be observed.
Danish: Høj fysiologisk optagelse af gallium (68Ga)-edotreotid i processus uncinatus pancreatis kan også observeres.
English: Total body Effective dose mSv/MBq
Danish: Skjoldbruskkirtel Urinblærevæg Livmoder Hele kroppen Effektiv dosis mSv/MBq
English: Thin layer chromatography (ITLC2, see details below)
Danish: Tyndtlagskromatografi (ITLC2, se yderligere oplysninger nedenfor)
English: Kit for radiopharmaceutical preparation containing: - Powder for solution for injection: the vial contains a white lyophilised powder.
Danish: Radiofarmaceutisk præparationssæt indeholdende: - Pulver til injektionsvæske, opløsning: hætteglasset indeholder et hvidt frysetørret pulver.
English: Excipients:
Danish: Producent:
English: Storage of radiopharmaceuticals should be in accordance with national regulation on radioactive materials.
Danish: Opbevaring af radioaktive lægemidler skal overholde den nationale lovgivning for radioaktive materialer.
English: The peptide is excreted via kidneys as intact compound.
Danish: Peptidet udskilles uomdannet via nyrerne.
English: The content of the kit before radiolabelling is not radioactive.
Danish: Hætteglassets indhold er ikke radioaktivt, før det er klargjort.
English: ITLC2: Material
Danish: ITLC2:
English: At the end of the elution, first withdraw the needle from the vacuum vial in order to establish atmospheric pressure into Vial 1, then disconnect Vial 1 from the generator by removing the needle from the rubber septum.
Danish: k. Ved slutningen af elueringen trækkes nålen først ud af vakuumhætteglasset for at etablere atmosfærisk tryk i hætteglas 1, derefter kobles hætteglas 1 fra generatoren ved at fjerne nålen fra gummimembranen.
English: In vivo, semiquantitative correlation was not assessed between gallium (68Ga) edotreotide uptake in tumours and the density of SSTR in histopathological samples neither in GEP-NET patients nor in normal organs.
Danish: En semikvantitativ korrelation mellem optagelse af gallium (68Ga)-edotreotid i tumorer og densiteten af SSTR i histopatologiske prøver er ikke blevet evalueret in vivo, hverken hos GEP-NET-patienter eller i normale organer.
English: - The other ingredients are: 1,10-phenanthroline, gentisic acid, mannitol, formic acid, sodium hydroxide, water for injections.
Danish: - Øvrige indholdsstoffer: 1,10-phenanthroline, gentisinsyre, mannitol, myresyre,
English: Talk to your nuclear medicine specialist before you are given SomaKit TOC: - if you experience any signs of allergic reaction (listed in section 4) after previous administration of SomaKit TOC; - if you have kidney or liver problems (renal or hepatic disease); - if you are under 18 years of age; - if you have signs of dehydration before and after the examination;
Danish: SomaKit TOC; - hvis du har problemer med dine nyrer eller din lever (nyre- eller leversygdomme); - hvis du er under 18 år; - hvis du har tegn på dehydrering (væskemangel) før eller efter undersøgelsen;
English: What SomaKit TOC looks like and contents of the pack SomaKit TOC is a kit for radiopharmaceutical preparation containing: - A glass vial with black flip-off cap containing a white powder.
Danish: SomaKit TOC er et radiofarmaceutisk præparationssæt indeholdende: - Et hætteglas med sort flip-off hætte indeholdende et hvidt pulver.
English: METHOD AND ROUTE(S) OF ADMINISTRATION To be radiolabelled with the reaction buffer and a solution of Gallium-68 (68Ga) in HCl provided by a germanium (68Ge)/gallium (68Ga) generator.
Danish: Skal radioaktivt mærkes med reaktionsbufferen og en opløsning af gallium-68 (68Ga) i HCl leveret af en germanium (68Ge)-/gallium (68Ga)-generator.
English: Connect Vial 1 through the 0.2 µm sterile vent filter to a vacuum vial or to a pump to start the elution.
Danish: j. Forbind hætteglas 1 via 0,2 μm sterilt udluftningsfilter til et vakuum hætteglas eller til en pumpe for at starte elueringen.
English: Table 1: Dosimetry of gallium (68Ga) edotreotide
Danish: Tabel 1: Dosimetri for gallium (68Ga)-edotreotid
English: The quality controls should be performed under a shielded screen for radioprotection purposes.
Danish: Kvalitetskontrollen skal udføres under en beskyttelsesafskærmning for at undgå radioaktiv stråling.
English: Withdraw the syringe and the 0.2 µm sterile vent filter and move the vial to the hole of the dry bath at 95°C, using a plier.
Danish: Fjern sprøjten og det 0,2 µm sterile ventilationsfilter og flyt hætteglasset til hullet i tørbadet ved 95 °C ved anvendelse af en tang.
English: Mechanism of action Gallium (68Ga) edotreotide binds to somatostatin receptors.
Danish: Virkningsmekanisme Gallium (68Ga)-edotreotid binder til somatostatin-receptorer (SSTR).
English: With a low dead space 1 ml sterile syringe carefully withdraw 0.5 ml reaction buffer, and keep the reaction buffer in syringe for step “i”.
Danish: Med en 1 ml steril sprøjte med lille deadspace trækkes 0,5 ml reaktionsbuffer op, og behold reaktionsbufferen i sprøjten indtil trin “i”.
English: Non-clinical data did not reveal any special hazard for gallium (68Ga) edotreotide in humans.
Danish: Prækliniske data har ikke vist speciel risiko ved gallium (68Ga)-edotreotid for mennesker.
English: Acceptance Criteria Method colloidal gallium-68 species Labelling efficiency % Free gallium-68
Danish: Mærkningseffektivitet % frit gallium-68
English: For instructions on extemporaneous preparation of the medicinal product before administration, see sections 6.6 and 12.
Danish: For instruktioner om fremstilling af lægemidlet før administration, se pkt.
English: monograph 2464 Gallium (68Ga) chloride solution for radiolabelling and that, in addition, is sterile and has been tested for compatibility with SomaKit TOC.
Danish: Det er beregnet til at blive radioaktivt mærket med en gallium (68Ga)-chloridopløsning, som overholder Ph.Eur.-monografi 2464 Gallium (68Ga)-chloridopløsning til radioaktiv mærkning, og som derudover er steril og er blevet testet for kompatibilitet med SomaKit TOC.
English: d. Scan the ITLC with a radiometric ITLC scanner The retention factor (Rf) specifications are as follows: gallium (68Ga) edotreotide = 0.1 to
Danish: d. Scan ITLC-strimlen med en radiometrisk ITLC-scanner Retentionsfaktor (Rf)-specifikationerne er følgende: gallium (68Ga)-edotreotid = 0,1 to 0,2
English: PHARMACEUTICAL FORM AND CONTENTS Kit for radiopharmaceutical preparation The box contains: - 1 vial of powder - 1 vial of buffer
Danish: Radiofarmaceutisk præparationssæt Æsken indeholder: - 1 hætteglas med pulver - 1 hætteglas med buffer
English: A lesion detection rate of 100% (40/40) versus 85% (34/40) was observed in the study of Hofmann et al. 2001 recruiting patients with histologically proven bronchial (n=2) or midgut (n=6) NETs.
Danish: 85 % (34/40) blev observeret i Hofmann et al. studiet (2001), hvori indgik patienter med histologisk dokumenterede NET udgået fra bronkie (n=2) eller ileum (midgut) (n=6).
English: Renal impairment / Hepatic impairment The safety and efficacy of gallium (68Ga) edotreotide have not been studied in patients with renal or hepatic impairment.
Danish: Nedsat nyre-/leverfunktion Sikkerheden og virkningen af gallium (68Ga)-edotreotid er ikke blevet undersøgt hos patienter med nedsat nyre- eller leverfunktion.
English: The safety and efficacy of gallium (68Ga) edotreotide has not been established in paediatric populations, where the effective dose might be different than in adults.
Danish: Sikkerheden og virkningen af gallium (68Ga)-edotreotid er ikke blevet undersøgt hos den pædiatriske population, og den effektive dosis kan være anderledes end hos voksne.
English: After radiolabelling, the solution obtained also contains hydrochloric acid.
Danish: Efter radioaktiv mærkning indeholder injektionsvæsken også saltsyre.
English: Data available on clinical efficacy of gallium (68Ga) edotreotide for the indication of predicting and monitoring of therapeutic response to peptide receptor radionuclide therapy (PRRT) in histologically confirmed metastatic NET are limited.
Danish: De tilgængelige data vedrørende den klinisk effektivitet af gallium (68Ga)-edotreotid til at forudsige og monitorerede terapeutisk respons på peptidreceptor-radionuklid-terapi (PRRT) i histologisk bekræftede metastatiske NET er begrænsede.
English: m. The solution should be visually inspected prior to use.
Danish: o. Injektionsvæsken skal inspiceres visuelt før brug.
English: If at any time in the preparation of this product the integrity of the vials is compromised it should not be used.
Danish: Hvis hætteglasset beskadiges på noget tidspunkt under klargøring af præparatet, må det ikke anvendes.
English: • One vial of buffer: 10 ml cyclic olefin polymer vial closed with a teflon stopper and sealed with a flip-off cap. Each vial contains 1 ml of reaction buffer.
Danish: • Et hætteglas med buffer: 10 ml hætteglas med cyklisk olefinpolymer lukket med en teflonprop og forseglet med en flip-off hætte.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS SHIELD LABEL TO BE APPLIED AFTER RADIOLABELLING
Danish: MINDSTEKRAV TIL MÆRKNING PÅ SMÅ INDRE EMBALLAGER ETIKET, DER SKAL SÆTTES PÅ BLYAFSKÆRMNINGEN EFTER RADIOAKTIV MÆRKNING
English: What you need to know before SomaKit TOC is used 3.
Danish: Det skal du vide, før du får SomaKit TOC 3.
English: How SomaKit TOC is used 4.
Danish: Sådan får du SomaKit TOC 4.
English: Connect the Vial 1 to the outlet line of the generator by pushing the needle through the rubber septum.
Danish: Forbind hætteglas 1 til generatorens udløbsslange ved at skubbe nålen gennem gummimembranen.
English: Data supporting efficacy of gallium (68Ga) edotreotide for predicting and monitoring of therapeutic response to peptide receptor radionuclide therapy (PRRT) in histologically confirmed metastatic NET are limited (see section 5.1).
Danish: Data, der understøtter gallium (68Ga)-edotreotids effektivitet til at forudsige og overvåge terapeutisk respons på peptidreceptor-radionuklid-terapi (PRRT) i histologisk bekræftede metastatiske NET, er begrænsede (se pkt.
English: After radiolabelling with gallium (68Ga) chloride solution, the solution of gallium (68Ga) edotreotide obtained is indicated for Positron Emission Tomography (PET) imaging of somatostatin receptor overexpression in adult patients with confirmed or suspected well-differentiated gastroenteropancreatic neuroendocrine tumours (GEP-NET) for localizing primary tumours and their metastases.
Danish: edotreotid-injektionsvæske indiceret til Positron Emission Tomografi (PET)-scanning af overekspression af somatostatin-receptorer hos voksne patienter med mistanke om eller bekræftede veldifferentierede gastroenteropankreatiske neuroendokrine tumorer (GEP-NET) for at lokalisere primære tumorer og deres metastaser.
English: For the detection of the primary GEP-NET site in case of rising levels of a relevant biochemical tumour marker or in case of proven NET metastasis, patient-based sensitivity and specificity of gallium (68Ga) edotreotide PET were 100% (4/4) and 89% (8/9), respectively, in the prospective study of Gabriel et al. 2007.
Danish: Klinisk virkning og sikkerhed Den patientbaserede sensitivitet og specificitet af gallium (68Ga)-edotreotid PET-scanning til lokalisation af den primære tumor ved GEP-NET i tilfælde af et forhøjet niveau af en relevant biokemisk tumormarkør eller påvist NET-metastase var hhv. 100 % (4/4) og 89 % (8/9) i det prospektive Gabriel et al. studie (2007).
English: (68 min), the biological half-life will have little impact on the effective half-life of the product which then would be expected to be somewhat less than 68 minutes.
Danish: Eftersom eliminationshastigheden er væsentligt langsommere end den fysiske halveringstid for gallium (68Ga) (68 min.), vil den biologiske halveringstid have ringe indflydelse på præparatets effektive halveringstid, som derefter ville forventes at være noget mindre end 68 minutter.
English: Renal/Hepatic impairment The pharmacokinetics in patients with renal or hepatic impairment has not been characterized.
Danish: Nedsat nyre-/leverfunktion Farmakokinetikken er ikke blevet karakteriseret hos patienter med nedsat nyre- eller leverfunktion.
English: A long-term exposure to endogenous hypercortisolism may down-regulate somatostatin receptor expression and negatively influence the results of somatostatin receptor imaging with gallium (68Ga)
Danish: En langvarig eksponering for endogen hyperkortisolisme kan nedregulere somatostatin-receptor-ekspressionen og påvirke resultatet af somatostatin-receptor-billeddannelse med gallium (68Ga)-edotreotid.
English: SPECT/CT while 3 patients did not exhibit any positive lesions on either imaging method.
Danish: edotreotid PET/CT-scanninger eller indium (111In)-pentetreotid SPECT/CT-scanninger, mens 3patienter ikke udviste nogen positive læsioner ved de 2 scanningsmetoder.
English: In the study of Lee et al. 2015 in 13 GEP-NET patients, a total of 35 positive lesions were detected in 10 patients on either gallium (68Ga) edotreotide PET/CT or indium (111In) pentetreotide
Danish: I Lee et al. studiet (2015) med 13 GEPNET-patienter blev i alt 35 positive læsioner hos 10 patienter detekteret på enten gallium (68Ga)
English: Pierce the Vial 1 septum with a 0.2 µm sterile vent filter in order to maintain atmospheric pressure within the vial during the radiolabelling process.
Danish: d. Prik hul på membranen på hætteglas 1 med et 0,2 µm sterilt ventilationsfilter for at opretholde atmosfæretrykket i hætteglasset under den radioaktive mærkning.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION SomaKit TOC 40 micrograms solution for injection Gallium (68Ga) edotreotide
Danish: LÆGEMIDLETS NAVN OG ADMINISTRATIONSVEJ(E) SomaKit TOC 40 mikrogram injektionsvæske, opløsning Gallium (68Ga)-edotreotid
English: Therefore, when treating patients with somatostatin analogues, it is preferable to perform imaging with gallium (68Ga) edotreotide the day(s) preceding the next administration of a somatostatin analogue.
Danish: Derfor foretrækkes det ved behandling af patienter med somatostatin-analoger, at billeddannelsen med gallium (68Ga)-edotreotid udføres dagen(e) før den næste dosis af en somatostatin-analog.
English: Paediatric population The safety and efficacy of gallium (68Ga) edotreotide has not been established in paediatric populations, where the effective dose might be different than in adults.
Danish: Pædiatrisk population Sikkerheden og virkningen af gallium (68Ga)-edotreotid er ikke blevet undersøgt hos den pædiatriske population, og den effektive dosis kan være anderledes end hos voksne.
English: After radiolabelling
Danish: efter radioaktiv mærkning
English: After radiolabelling, the solution obtained also contains, as excipient, hydrochloric acid from the generator eluate.
Danish: Efter radioaktiv mærkning indeholder injektionsvæsken også saltsyre (hjælpestof) fra generatoreluatet.
English: In case of Cushing syndrome, a long-term exposure to endogenous hypercortisolism may down regulate somatostatin receptor expression and negatively influence the results of somatostatin receptor imaging with gallium (68Ga) edotreotide.
Danish: Hos patienter med Cushings syndrom kan en langvarig eksponering for endogen hyperkortisolisme nedregulere somatostatin-receptor-ekspressionen og påvirke resultatet af somatostatin-receptorbilleddannelse med gallium (68Ga)-edotreotid.
English: Store the vial containing the gallium (68Ga) edotreotide solution below 25°C until use.
Danish: Opbevar hætteglasset med gallium (68Ga)-edotreotid-injektionsvæsken ved temperaturer under 25°C, indtil det skal bruges.
English: b. Apply a drop of the gallium (68Ga) edotreotide solution on a pencil line 1 cm from the bottom of the ITLC strip.
Danish: b. Sæt en dråbe af gallium (68Ga)-edotreotid på en blyantstreg 1 cm fra bunden af ITLC
English: • One vial of powder for solution for injection: 10 ml Type I glass vial closed with a bromobutyl rubber stopper and sealed with a flip-off cap. Each vial contains 40 micrograms of edotreotide.
Danish: • 1 hætteglas med pulver til injektionsvæske, opløsning: 10 ml type I-hætteglas lukket med en brombutyl-gummiprop og forseglet med en flip-off hætte.
English: Women of childbearing potential
Danish: Kvinder i fertil alder
English: Before administration of SomaKit TOC
Danish: Før du får SomaKit TOC
English: Hypersensitivity to the active substance, to any of the excipients listed in section 6.1 or to any of the components of the labelled radiopharmaceutical.
Danish: Overfølsomhed over for det aktive stof, over for et eller flere af hjælpestofferne anført i pkt.
English: Quality control Table 2: Specifications of the gallium (68Ga) edotreotide
Danish: Tabel 2: Specifikationer for gallium (68Ga)-edotreotid