FrancophonIA/ELRC3.0 huggingface dataset:
English: Breast-feeding should be discontinued for at least 24 hours after the administration of Optimark.
Danish: Amning skal ophøre i mindst 24 timer efter indgivelse af Optimark.
English: Precautions to be taken before handling or administering the medicinal product The container and the solution should be inspected prior to use.
Danish: Forsigtighedsregler, der skal tages før håndtering og administration af lægemidlet Beholderen og opløsningen skal inspiceres inden brug.
English: Children and adolescents Optimark is not recommended in children who are below the age of two years.
Danish: Børn og teenagere Optimark bør ikke anvendes til børn under to år.
English: Breast-feeding should be discontinued for at least 24 hours after you receive Optimark.
Danish: De må ikke amme i mindst 24 timer efter, De har fået Optimark.
English: Caution should be exercised in elderly patients (see section 4.4).
Danish: Der bør udvises forsigtighed hos ældre patienter (se pkt.
English: As with any paramagnetic contrast agent, enhancement of MRI with gadoversetamide may impair the visualization of existing lesions.
Danish: Som ved alle paramagnetiske kontrastmidler kan kontrastøgningen af MR-billederne med gadoversetamid hæmme visualiseringen af eksisterende læsioner.
English: • patients in the perioperative liver transplantation period and in
Danish: • patienter i den perioperative levertransplantationsperiode, samt til
English: The elimination half life at the 100 micromol/kg dose ranges from 1.49 ± 0.15 h in healthy volunteers to 2.11 ± 0.62 h in non-renally impaired patients (including normal subjects and patients with CNS or liver pathology).
Danish: Udskillelseshalveringstiden ved en dosis på 100 mikromol/kg ligger fra 1,49 ± 0,15 h hos raske frivillige til 2,11 ± 0,62 h hos forsøgspersoner uden nedsat nyrefunktion (inklusive normale forsøgspersoner og patienter med CNS eller leverpatologi).
English: Therefore, within this dose range, the kinetics of gadoversetamide appear to be linear.
Danish: Derfor lader kinetikken for gadoversetamid til at være lineær inden for dette dosisområde.
English: Detailed information on this medicine is available on the European Medicines Agency (EMA) web site http://www.ema.europa.eu.
Danish: De kan finde yderligere oplysninger om dette lægemiddel på Det Europæiske Lægemiddelagenturs (EMEAs) hjemmeside http://www.ema.europa.eu
English: OTHER SPECIAL WARNING(S), IF NECESSARY This sticky label should be stuck on patient records.
Danish: EVENTUELLE ANDRE SÆRLIGE ADVARSLER Denne selvklæbende etiket skal klæbes ind i patientjournalen.
English: Syringe tip cap and piston are made of bromobutyl rubber.
Danish: Sprøjtens spidsmuffe og stempel er fremstillet af brombutylgummi.
English: What Optimark is and what it is used for What you need to know before you are given Optimark How Optimark is given
Danish: Virkning og anvendelse Det skal De vide, før De får Optimark Sådan vil De få Optimark Bivirkninger
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu.
Danish: De kan finde yderligere oplysninger om dette lægemiddel på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu
English: Prior to administration of Optimark, all patients should be screened for renal dysfunction by obtaining laboratory tests.
Danish: Alle patienter bør screenes for nedsat nyrefunktion ved at rekvirere laboratorieanalyser, før Optimark indgives.
English: Since the hepatic artery and portal venous system supply approximately 20% and 80% of the hepatic blood supply, respectively, the earlier (hepatic arterial phase) images provide optimal lesion conspicuity for hypervascular lesions and the portal venous phase images are useful for hypovascular lesions (most metastatic lesions are relatively hypovascular and are better demonstrated during the portal venous phase, manifesting as areas of lower signal intensity compared with the markedly enhanced liver).
Danish: Da arteria hepatica communis og portvenesystemet bidrager med henholdsvis cirka 20% og 80% af blodforsyningen til leveren, vil de tidligste (arteria hepatica-fasen) billeder give optimal læsionstydelighed for hypervaskulære læsioner.
English: Blood calcium abnormal
Danish: Unormalt niveau af calcium i blodet
English: • The other ingredients are: versetamide, calcium hydroxide, calcium chloride dihydrate, sodium hydroxide and/or hydrochloric acid, water for injections.
Danish: • Øvrige indholdsstoffer: versetamid, calciumhydroxid, calciumchloriddihydrat, natriumhydroxid og/eller saltsyre, vand til injektionsvæsker.
English: Most of the side effects observed after the use of Optimark were of mild to moderate intensity and transient in nature.
Danish: De fleste bivirkninger, der er set efter anvendelse af Optimark, er forbigående og af let til moderat intensitet.
English: Therefore, Optimark must not be used in patients who have had or are undergoing liver transplantation and in neonates (see section 4.3).
Danish: Derfor må Optimark ikke anvendes til patienter, som har fået eller skal have foretaget en levertransplantation, og til nyfødte (se pkt.
English: You must not be given Optimark if
Danish: De må ikke få Optimark
English: < 30ml/min/1.73 m2) and/or acute kidney injury, in
Danish: ml/min/1,73 m2) og/eller akut nyreskade, til
English: Gadoversetamide has been shown to cause interference in the measurement of serum calcium using the ortho-cresolphthalein complexone (OCP) colorimetric method.
Danish: Gadoversetamid har vist sig at forårsage interferens i måling af serumcalcium ved brug af den orthocresolftalein complexon (OCP) colorimetriske metode.
English: • in neonates up to 4 weeks of age (see section 4.4).
Danish: • til nyfødte under 4 uger (se pkt.
English: Precautions to be taken before handling or administering the medicinal product The container and the solution should be inspected prior to use as described in section 6.6.
Danish: Forsigtighedsregler, der skal tages før håndtering og administration af lægemidlet Beholderen og opløsningen skal inspiceres inden brug som beskrevet under pkt.
English: The MAH shall submit annual cumulative reviews on nephrogenic systemic fibrosis (NSF) cases.
Danish: Indehaveren af markedsføringstilladelsen skal indsende årlige kumulerede oversigter over tilfælde af nefrogen systemisk fibrose (NSF).
English: Optimark should only be used after careful risk/benefit evaluation in patients with moderate renal impairment (GFR 30-59 ml/min/1.73 m2) at a dose not exceeding 100 micromol/kg body weight.
Danish: Optimark bør kun anvendes efter grundig evaluering af risk/benefit hos patienter med moderat nedsat nyrefunktion (GFR 30-59 ml/min/1,73 m2) og ved en dosis, som ikke overstiger 100 mikromol/kg legemsvægt (se pkt.
English: • you suffer from allergies (e.g. medicinal products, seafood, hay fever, hives) or asthma
Danish: • De lider af allergi (f.eks. over for lægemidler, skaldyr, høfeber, nældefeber) eller astma
English: Gadoversetamide plasma levels increase linearly with decreasing renal function; in patients with severe renal impairment (CrCl<30 ml/min) this even leads to a six-fold decreased gadoversetamide clearance and a corresponding six-fold increased extent of exposure AUC and t½.
Danish: Hos patienter med alvorligt nedsat nyrefunktion (CrCl<30 ml/min) kan dette endog medføre en seks gange mindsket gadoversetamid-clearance og en tilsvarende seks gange øget eksponeringsgrad AUC og t½.
English: Palpitations, AV block first Tachycardia, Arrhythmia
Danish: Palpitationer, AV-blok af første grad, ekstrasystoler, takykardi, arytmi
English: • neonates up to 4 weeks of age.
Danish: • nyfødte under 4 uger.
English: • in patients who have had liver transplantation or
Danish: • til patienter, som har gennemgået en levertransplantation, eller
English: Optimark pre-filled syringes are supplied in the following package sizes: 1 x 10 ml 10 x 10 ml
Danish: Optimark hætteglas leveres i følgende pakningsstørrelser: 1 x 10 ml
English: • Hypersensitivity to gadoversetamide or to other gadolinium containing products or to any of the excipients.
Danish: • Overfølsomhed over for gadoversetamid eller over for andre gadoliniumholdige produkter eller over for et eller flere af hjælpestofferne.
English: The elimination half life in the 2 to 11 and 12 to 18 year age groups (1.4 ± 0.3 and 1.6± 0.3 h-1, respectively) is shorter than that observed in the two adult populations (1.9 ± 0.5 and 2.5± 0.5 h-1 in the 19 to 64 and ≥ 65 year of age groups, respectively).
Danish: Udskillelseshalveringstiden i aldersgrupperne 2 til 11 og 12 til 18 år (henholdsvis 1,4 ± 0,3 og 1,6 ± 0,3 h-1) er kortere end den, der observeredes hos de to voksne populationer (henholdsvis 1,9 ± 0,5 og
English: • Optimark is not recommended for use in children below the age of two years because the safety, efficacy, and impact of immature kidney function have not been studied in this age group.
Danish: • Optimark bør ikke anvendes til børn under 2 år, idet sikkerhed og virkning samt betydningen af en umoden nyrefunktion ikke er undersøgt hos denne aldersgruppe.
English: The majority of adverse reactions observed after the use of gadoversetamide were found to be adverse reactions of the nervous system, followed by general adverse reactions, gastrointestinal disorders/skin and subcutaneous tissue disorders.
Danish: De fleste bivirkninger, der blev observeret efter anvendelse af gadoversetamid, var bivirkninger i nervesystemet efterfulgt af generelle bivirkninger samt bivirkninger fra mave-tarm-kanalen og hud og subkutane væv.
English: Excipients: versetamide, calcium hydroxide, calcium chloride dihydrate, sodium hydroxide and/or hydrochloric acid, water for injections.
Danish: Hjælpestoffer: versetamid, calciumhydroxid, calciumchloriddihydrat, natriumhydroxid og/eller saltsyre, vand til injektionsvæsker.
English: Chills, Pain, Face oedema, Asthenic conditions including asthenia, fatigue, and malaise, Fever, Oedema peripheral,
Danish: Kuldegysninger, smerter, ansigtsødem, asteniske tilstande inklusive asteni, træthed og utilpashed, feber, perifert ødem, følelse af at være unormal
English: Do not use the solution if it is discoloured or particulate matter is present.
Danish: Opløsningen må ikke anvendes, hvis den er misfarvet eller indeholder partikler.
English: hardening of the skin which may affect also soft tissue and internal organs (nephrogenic systemic fibrosis), feeling unwell
Danish: Hærdning af huden, som også kan påvirke bløddele og indre organer (nefrogen
English: Optimark is filled in pre-filled syringes made of polypropylene.
Danish: Optimark leveres i fyldte injektionssprøjter fremstillet af polypropylen.
English: Effect of Renal Impairment
Danish: Indvirkningen af nedsat nyrefunktion
English: Patients with impaired renal function
Danish: Patienter med nedsat nyrefunktion
English: Before the injection of contrast media, patients should be asked whether they have any allergies (e.g. allergies to seafood or medicinal products, hay fever, urticaria), whether they are hypersensitive to contrast media and whether they have bronchial asthma.
Danish: Før injektion af kontrastmidlet skal patienterne spørges, om de har nogen allergi (f.eks. allergier over for skaldyr eller lægemiddelprodukter, høfeber, urticaria), om de er overfølsomme over for kontrastmidler, og om de har bronkiel astma.
English: Prior to using the syringe, twist off grey tip cap and discard.
Danish: Inden sprøjten bruges, drejes den grå spidsmuffe af og kasseres.
English: 10 ml vials and 15 ml vials contain less than 1 mmol sodium; i.e. they are essentially ‘sodium free‘.
Danish: 10 ml hætteglas og 15 ml hætteglas indeholder mindre end 1 mmol natrium, dvs. de er i det væsentlige natriumfrie.
English: General Disorders and Administration Site Conditions
Danish: Almene symptomer og reaktioner på administrationsstedet
English: In cranial MRI, if a strong clinical suspicion of a lesion persists despite a single dose contrastenhanced MRI or when more accurate information on the number, size or extent of lesions might influence management or therapy of the patient, in subjects with normal renal function, a second bolus injection of 0.2 ml/kg (100 micromol/kg) may be administered within 30 minutes of the first injection as it may increase the diagnostic yield of the examination.
Danish: Ved kraniel MRI, hvor der stadig foreligger stærk klinisk mistanke om en læsion efter der er foretaget en kontrastforstærket MRI med en enkelt dosis kontrastmiddel, eller hvor mere nøjagtig information om antal, størrelse eller omfang af læsioner kan påvirke behandlingen af patienten, kan der hos personer med normal nyrefunktion administreres en ekstra bolusinjektion på 0,2 ml/kg (100 mikromol/kg) inden for 30 minutter fra den første injektion, da dette kan forbedre det diagnostiske udbytte af undersøgelsen.
English: • to other gadolinium contrast agents.
Danish: • andre gadolinium-kontrastmidler
English: Calcium chloride dihydrate
Danish: Calciumchloriddihydrat
English: In patients suffering from epilepsy or brain lesions the likelihood of convulsions during the examination may be increased.
Danish: Sandsynligheden for krampeanfald under undersøgelsen er muligvis højere hos patienter, der lider af epilepsi eller hjernelæsioner.
English: Patients taking beta-blockers
Danish: Patienter, der tager betablokkere
English: Use of Optimark is not recommended in children less than 2 years of age because the safety, efficacy, and impact of immature kidney function have not been studied in this age group.
Danish: Optimark bør ikke anvendes til børn under 2 år, idet sikkerhed og virkning samt betydningen af umoden nyrefunktion ikke er undersøgt hos denne aldersgruppe.
English: The vials are fitted with bromobutyl rubber closures, aluminium cap seals, and plastic flip caps.
Danish: Hætteglassene er forsynet med brombutylgummipropper, aluminiumhætter og vippelåg af plast.
English: Gadolinium containing MRI contrast agents (gadolinium-based chelates) are designed to act indirectly on the local magnetic environment by altering proton T1 (spin-lattice) and T2 (spin-spin) relaxation times and at the usual concentration of 100 micromol/kg, the T1 shortening predominates, and the T2 shortening is not significant using T1-weighted sequences.
Danish: Gadolinium-holdige MRI-kontrastmidler (gadolinium-baserede kelater) er udviklet til indirekte at påvirke det lokale magnetiske miljø ved at ændre proton T1- (spin-gitter) og T2- (spin-spin) relaxationstiderne.
English: The risk for development of NSF in patients with moderate renal impairment (GFR 30-59 ml/min/1.73 m²) is unknown; therefore Optimark should only be used after careful risk-benefit evaluation in patients with moderate renal impairment.
Danish: Risikoen for at udvikle NSF hos patienter med moderat nedsat nyrefunktion (GFR 30-59 ml/min/1,73 m²) er ukendt, derfor bør Optimark kun anvendes efter en grundig evaluering af risk/benefit hos patienter med moderat nedsat nyrefunktion.
English: • patients who have had liver transplantation or in
Danish: • patienter, som har gennemgået en levertransplantation, eller til
English: Respiratory, Thoracic and Mediastinal Disorders
Danish: Luftveje, thorax og mediastinum
English: If solids remain, the vial must be discarded.
Danish: Hvis der er resterende faststoffer, skal hætteglasset destrueres.
English: There have been reports of nephrogenic systemic fibrosis (NSF) associated with use of Optimark and some gadolinium-containing contrast agents in patients with acute or chronic severe renal impairment (GFR <30ml/min/1.73m2) and/or acute kidney injury.
Danish: Der er indberettet nefrogen systemisk fibrose (NSF) i forbindelse med anvendelse af Optimark og visse gadolinium-holdige kontrastmidler hos patienter med akut eller kronisk alvorligt nedsat nyrefunktion (GFR <30ml/min/1,73m2) og/eller akut nyreskade.
English: Central nervous system disorders
Danish: Lidelser i centralnervesystemet
English: Prior to the launch, the MAA shall provide to all potential prescribers a copy of the SPC with a cover letter highlighting the safety information included in Sections 4.3 and 4.4.
Danish: Før produktet markedsføres, skal indehaveren af markedsføringstilladelsen udlevere et eksemplar af produktresumeet til alle potentielt ordinerende læger sammen med et følgebrev, som understreger sikkerhedsinformationen i pkt.
English: There have been reports of nephrogenic systemic fibrosis (NSF) associated with use of Optimark and some gadolinium-containing contrast agents in patients with acute or chronic severe renal impairment (GFR < 30ml/min/1.73 m²) and/or acute kidney injury.
Danish: Der er indberettet nefrogen systemisk fibrose (NSF) i forbindelse med anvendelse af Optimark og visse gadolinium-holdige kontrastmidler hos patienter med akut eller kronisk alvorligt nedsat nyrefunktion (GFR < 30 ml/min/1,73 m²) og/eller akut nyreskade.
English: Versetamide
Danish: Versetamid
English: System Organ Class (MedDRA)
Danish: Systemorganklasse
English: During the examination, supervision by a physician is necessary and insertion of a flexible in-dwelling catheter is recommended.
Danish: Lægeovervågning er nødvendig under undersøgelsen, og det anbefales at anlægge i.v.-adgang.
English: 30 ml of the solution contain 43.13 mg sodium.
Danish: 30 ml opløsning indeholder 43,13 mg natrium.
English: The risk of hypersensitivity reactions is increased in the following cases: - patients with allergic predisposition - patients with bronchial asthma; in these patients it is especially the risk of bronchospasm which is increased - patients with a history of reactions to contrast agents, including a previous history of reaction to iodine-based contrast agents
Danish: Hos disse patienter er det især risikoen for bronchospasme, der er øget - patienter med reaktioner på kontrastmidler i anamnesen, herunder tidligere reaktioner på jodbaserede kontrastmidler
English: Optimark is supplied in vials, fitted with bromobutyl rubber closures and aluminium cap seals.
Danish: Optimark leveres i hætteglas forsynet med brombutylgummipropper og aluminium hætter.
English: Salivary hypersecretion,, Abdominal pain, Constipation, Dry mouth
Danish: Hypersekretion af spyt, mavesmerter, konstipation, mundtørhed
English: • if you are a patient who is about to have or has had a liver transplant as use of Optimark in patients with these conditions has been associated with a disease called nephrogenic systemic fibrosis (NSF).
Danish: Hos disse patienter er brugen af Optimark blevet forbundet med en sygdom ved navn nefrogen systemisk fibrose (NSF).
English: Syringe is now ready for needle or infusion tubing attachment.
Danish: Sprøjten er nu egnet til fastgørelse af kanyle eller infusionsslangeudstyr.
English: When corrected for body weight, the total body clearance of gadoversetamide is greater in the 2 to 11 year age group (143 ± 27.9 ml/h/kg) than that observed in the 12 to 18 year age group (117 ± 26.1
Danish: Ved korrektion for legemsvægt er den totale clearance af gadoversetamid i kroppen større i aldersgruppen 2 til 11 år (143 ± 27,9 ml/h/kg) end den, der blev observeret i aldersgruppen 12 til 18 år (117 ± 26,1 ml/h/kg) og i de to voksne populationer (henholdvis 82,1 ± 16,8 og 56,5 ± 9,7 ml/h/kg i aldersgrupperne 19 til 64 og ≥ 65 år).
English: Hypoaesthesia, Paraesthesia, Parosmia
Danish: Svimmelhed, hypæstesi paræstesi, parosmi
English: Rhinorrhoea, Throat tightness, Laryngeal/pharyngeal oedema, Pharyngitis, Rhinitis, Sneezing
Danish: Dyspnø, dysfoni, rinorré, "sammensnøring" af halsen, bronkospasme, hoste, laryngealt/faryngealt ødem, faryngitis, rinitis, nysen
English: Confusion and disorientation
Danish: Uro, søvnforstyrrelser, konfusion og desorientering
English: Discard syringe and unused portion of the solution after use.
Danish: Sprøjten og ikke anvendte portioner af opløsningen skal destrueres efter brug.
English: What Optimark contains
Danish: Optimark indeholder:
English: The purpose of an MRI contrast agent is to induce signal intensity changes within the lesion thereby facilitating its recognition from the surrounding normal structures.
Danish: Formålet med et MRI-kontrastmiddel er at fremkalde/forstærke signalintensitetsforandringer i en læsion.
English: Hypersensitivity to gadoversetamide or to other gadolinium containing products, or to any of the excipients listed in section 6.1.
Danish: Overfølsomhed over for gadoversetamid eller over for andre gadoliniumholdige produkter eller over for et eller flere af hjælpestofferne anført i pkt.
English: Nevertheless, because of reported cases of NSF that may be associated with renal impairment for other gadolinium containing contrast agents and for gadoversetamide, Optimark should not be used in these patients.
Danish: Ikke desto mindre bør Optimark ikke anvendes til disse patienter på grund af indberettede tilfælde af NSF, som kan være forbundet med nedsat nyrefunktion for andre gadolinium-holdige kontrastmidler og for gadoversetamid.
English: • The active substance is gadoversetamide.
Danish: • Aktivt stof:gadoversetamid.
English: Optimark can be removed by haemodialysis.
Danish: Optimark kan fjernes med hæmodialyse.
English: SPECIAL STORAGE CONDITIONS Keep the syringe in the outer carton in order to protect from light.
Danish: SÆRLIGE OPBEVARINGSBETINGELSER Opbevar hætteglasset i den ydre karton for at beskytte mod lys.
English: To enable immediate action in emergencies, the necessary medicinal products (e.g. epinephrine/adrenaline, theophylline, antihistamines, corticosteroids and atropines), endotracheal tube and ventilator must be immediately available.
Danish: For at muliggøre omgående handling i nødstilfælde skal de nødvendige lægemiddelprodukter (f.eks. epinefrin/adrenalin, theofyllin, antihistaminer, kortikosteroider og atropiner), endotrakealtube og ventilator være umiddelbart tilgængelige.
English: Still, after 72 hours even in patients with severe renal impairment nearly the whole dose is recovered in the urine and in healthy populations up to 500 micromol/kg doses were administered without safety issues.
Danish: Hos raske populationer blev der administreret doser på op til 500 mikromol/kg uden sikkerhedsproblemer.
English: Limited data with other gadolinium contrast agents suggests that for the exclusion of additional cranial metastases in a patient with a known solitary resectable metastasis, an MR exam with the injection of 300 micromol/kg body weight of Optimark may lead to higher diagnostic confidence.
Danish: Begrænsede data fra andre gadolinium-kontrastmidler tyder på, at foretagelsen af en MR-undersøgelse med injektion af 300 mikromol/kg legemsvægt Optimark muligvis kan føre til større diagnostisk sikkerhed med hensyn til udelukkelse af yderligere kranielle metastaser hos en patient med en kendt solitær, resektabel metastase.
English: Very rare (may affect up to 1 in 10,000 people)
Danish: Meget sjældne (kan forekomme hos op til 1 ud af 10.000 personer)
English: To enable immediate action in emergencies, the necessary medicinal products (e.g. epinephrine/ adrenaline, theophylline, antihistamines, corticosteroids and atropines), endotracheal tube and ventilator must be immediately available.
Danish: For at kunne handle øjeblikkeligt i nødstilfælde, skal de nødvendige lægemidler (f.eks. adrenalin (epinephrin), theophyllin, antihistaminer, kortikosteroider og atropin), endotrakealtube og ventilator være umiddelbart tilgængelige.
English: You must report any of the following symptoms immediately to the doctor or nurse/technologist, and get immediate treatment as they can be or can become very serious: side effects affecting the heart (fainting, extra heart beats, chest pain) or the respiratory system (shortness of breath, tightening of the airways, swollen or tight throat, itchy or runny nose, sneezing).
Danish: Bivirkninger, som påvirker hjertet (besvimelse, ekstra hjerteslag, brystsmerter) eller luftvejene (kortåndethed, ”sammensnøring” af luftvejene, hævelse eller ”sammensnøring” af halsen, kløende eller rindende næse, nysen).
English: Allergoid and other idiosyncratic reactions also may occur with gadoversetamide, which could become manifest in form of cardiovascular, respiratory and skin reactions.
Danish: Allergiske og andre idiosynkratiske reaktioner kan også forekomme med gadoversetamid.