FrancophonIA/ELRC3.0 huggingface dataset:
English: When in doubt, it is important to consult your nuclear medicine doctor who will supervise the procedure.
Danish: Hvis De er i tvivl, er det vigtigt, at De spørger den nuklearmedicinske læge, som skal overvåge undersøgelsen, til råds.
English: I) in determining probable DLB from non-DLB ranged from 75.0% to 80.2% and specificity from 88.6% to 91.4%.
Danish: I)-sensitivitetsværdier til bestemmelse af sandsynlig DLB fra ikke-DLB varierede fra 75,0 % til 80,2 % og specificiteten fra 88,6 % til 91,4 %.
English: • if you are allergic to ioflupane or any of the other ingredients of this medicine (listed in section 6)
Danish: Brug ikke Striascan: - hvis De er allergisk over for ioflupan eller et af de øvrige indholdsstoffer i Striascan (angivet i afsnit 6).
English: This medicine is a radiopharmaceutical product for diagnostic use only.
Danish: Dette lægemiddel er et radioaktivt præparat, der kun er beregnet til diagnostisk brug.
English: Your nuclear medicine doctor will inform you about the usual duration of the procedure.
Danish: Den nuklearmedicinske læge vil informere Dem om, hvor længe undersøgelsen sædvanligvis varer.
English: The estimated absorbed radiation doses to an average adult patient (70 kg) from intravenous injection of ioflupane (
Danish: De estimerede, absorberede strålingsdoser i henhold til ICRP 128 hos en gennemsnitlig voksen patient (70 kg) efter intravenøs injektion af ioflupan (
English: Striascan is given to you as an injection, usually into a vein in your arm. A single injection is enough.
Danish: De vil få Striascan som en injektion, sædvanligvis i en blodåre i armen.
English: Uncommon (1/1,000 to <1/100) Rare
Danish: Ikke almindelig (1/1.000 til <1/100) Sjælden
English: UNIQUE IDENTIFIER - 2D BARCODE Not applicable.
Danish: 17 ENTYDIG IDENTIFIKATOR - 2D-STREGKODE
English: Careful consideration of the benefit risk ratio in these patients is required since an increased radiation exposure is possible.
Danish: Benefit/risk-forholdet skal evalueres grundigt hos sådanne patienter, da der er en risiko for øget strålingseksponering.
English: Studies in animals have shown that ioflupane binds with high affinity to the presynaptic dopamine transporter and so radiolabelled ioflupane (
Danish: Dyrestudier har vist, at ioflupan binder med høj affinitet til den præsynaptiske dopamin-transporter; derfor kan radioaktivt mærket ioflupan (
English: You must inform the nuclear medicine doctor before the administration of Striascan if there is a possibility you might be pregnant, if you have missed your period or if you are breast-feeding.
Danish: De skal informere den nuklearmedicinske læge inden indgivelse af Striascan, hvis der er en mulighed for, at De kan være gravid, hvis en menstruation er udeblevet, eller hvis De ammer.
English: I) ranging from 75.0% to
Danish: I), der varierede fra 75,0 % til 80,2 %.
English: Careful consideration of the activity to be administered is required since an increased radiation exposure is possible in these patients.
Danish: Det skal overvejes grundigt, hvor megen aktivitet, der skal administreres, da der er risiko for øget strålingseksponering hos sådanne patienter.
English: Small intestine wall Colon wall (Upper large intestine wall ) (Lower large intestine wall) Heart wall
Danish: Tyndtarmsvæg Kolonvæg (Øvre tyktarmsvæg) (Nedre tyktarmsvæg) Hjertevæg
English: These stop the radioactivity building-up in your thyroid gland.
Danish: Det vil forhindre ophobning af radioaktivitet i Deres skjoldbruskkirtel.
English: Precautions with respect to environmental hazard see section 6.6.
Danish: Forholdsregler med hensyn til miljørisiko, se pkt.
English: Do not use this medicine after the expiry date which is stated on the labels after EXP. Hospital staff will ensure that the product is stored and thrown away correctly and not used after the expiry date stated on the label.
Danish: Hospitalets personale sørger for, at produktet opbevares og bortskaffes korrekt og ikke anvendes efter udløbsdatoen angivet på etiketten.
English: EXP: DD/MM/YYYY xx h xx CET
Danish: EXP: DD/MM/ÅÅÅÅ klokken xx:xx
English: 370 MBq / vial at ref. (see outer label) 74 MBq / mL
Danish: 370 MBq/hætteglas på ref. (se ydre etiket) 74 MBq/ml
English: Other medicines and Striascan
Danish: Brug af anden medicin sammen med Striascan
English: • bupropion (used to treat depression (sadness))
Danish: • bupropion (anvendes til at behandle depression (nedtrykthed))
English: Care should be taken to avoid contamination from the radioactivity eliminated by the patient using such methods.
Danish: Der bør i disse tilfælde tages forholdsregler for at undgå forurening fra den radioaktive udskillelse fra patienten.
English: Striascan has no known influence on the ability to drive and use machines.
Danish: Striascan påvirker ikke eller kun i ubetydelig grad evnen til at føre motorkøretøj eller betjene maskiner.
English: What Striascan looks like and contents of the pack Striascan is a colourless solution for injection, supplied in a single amber 15 mL glass vial sealed with a rubber closure and metal overseal.
Danish: Striascan er en farveløs injektionsvæske, opløsning, der leveres i ét enkelt ravgult 15 ml hætteglas forseglet med et gummilukke og metalforsegling.
English: - The other ingredients are acetic acid, glacial (E 260); sodium acetate trihydrate (E 262), ethanol, anhydrous (E 1510); phosphoric acid, concentrated (E 338) and water for injections.
Danish: - Øvrige indholdsstoffer: eddikesyre, koncentreret (E260); natriumacetat trihydrat (E262), ethanol, vandfri (E1510); phosphorsyre, koncentreret (E338) og vand til injektionsvæsker.
English: Before administering radiopharmaceuticals to a mother who is breast-feeding, consideration should be given to the possibility of delaying the administration of radionuclide until the mother has ceased breastfeeding, and to what is the most appropriate choice of radiopharmaceuticals, bearing in mind the secretion of activity in breast milk.
Danish: Før indgivelse af et radioaktivt lægemiddel til en kvinde, der ammer, skal det overvejes, om det er muligt at udskyde indgivelse af et radionukleid, indtil moderen er ophørt med at amme.
English: Each 2.5 mL single dose vial contains 185 MBq ioflupane (
Danish: Hvert 2,5 ml enkeltdosishætteglas indeholder 185 MBq ioflupan (
English: For all organs and tissues, 80% is assumed to be excreted with a biological half-time of 58 h, and 20% with a half-time of 1.6 h. It is further assumed that 60% of the injected activity is excreted to the urine, and 40% is excreted to the gastrointestinal tract for all organs and tissues.
Danish: For alle organer og væv antages det, at 80 % udskilles med en biologisk halveringstid på 58 timer og 20 % med en halveringstid på 1,6 timer.
English: Salivary glands Skin
Danish: Spytkirtler Hud
English: If you get any side effects, talk to your nuclear medicine doctor.
Danish: Hvis De oplever bivirkninger, bør De tale med Deres nuklearmedicinske læge, sygeplejerske eller apoteket.
English: What you need to know before Striascan is used
Danish: Det skal De vide, før De begynder at bruge Striascan
English: Metabolism and nutrition disorders
Danish: Metabolisme og ernæring Øget appetit
English: Acetic acid, glacial (E 260) Sodium acetate, trihydrate (E 262) Ethanol, anhydrous (E 1510) Phosphoric acid, concentrated (E 338) Water for injections
Danish: Eddikesyre, koncentreret (E260) Natriumacetat, trihydrat (E262) Ethanol, vandfri (E1510) Phosphorsyre, koncentreret (E338) Vand til injektionsvæsker.
English: Striascan 74 MBq/mL solution for injection ioflupane (
Danish: Striascan 74 MBq/ml injektionsvæske, opløsning ioflupan (
English: Store in the original lead shielding.
Danish: Opbevares i den originale blybeholder.
English: Striascan contains the active substance ioflupane (
Danish: Striascan indeholder det aktive stof ioflupan (
English: This is harmful for those suffering from alcoholism and needs to be taken into account in pregnant or breastfeeding women, children and high-risk groups such as patients with liver disease or epilepsy.
Danish: Anvend kun dette lægemiddel til børn, gravide og ammende kvinder og patienter i højrisikogruppe såsom patienter med epilepsi og leversygdomme efter aftale med lægen.
English: • amfetamine (used to treat hyperactivity in children and narcolepsy (excessive sleepiness);
Danish: • amfetamin (anvendes til at behandle hyperaktivitet hos børn og narkolepsi (overdreven søvnighed); også et misbrugsstof)
English: MedDRA Body system SOCs
Danish: Systemorganklasser i henhold til MedDRA
English: • dementia with Lewy bodies.
Danish: • Lewy-body-demens
English: The biokinetic model for ioflupane (
Danish: Den biokinetiske model for ioflupan (
English: Striascan 74 MBq/mL solution for injection
Danish: Striascan 74 MBq/ml injektionsvæske, opløsning
English: • Instead use formula feed for your child. Express your breast milk regularly and throw away any breast milk you have expressed.
Danish: Malk regelmæssigt brystmælken ud, og kasser al den udmalkede mælk.
English: Each mL of solution contains 74 MBq of ioflupane (
Danish: Hver ml opløsning indeholder 74 MBq ioflupan (
English: Bone surfaces Brain
Danish: Knogleoverflade Hjerne
English: Pack size: 1 vial containing 2.5 mL or 5 mL.
Danish: Pakningsstørrelse: 1 hætteglas med 2,5 ml eller 5 ml.
English: Each 5 mL single dose vial contains 370 MBq ioflupane (
Danish: Hvert 5 ml enkeltdosishætteglas indeholder 370 MBq ioflupan (
English: Nausea, dry mouth
Danish: Kvalme, mundtørhed
English: Very rare Not known (cannot be estimated from the available data)
Danish: (kan ikke estimeres ud fra forhåndenværende data)
English: You can also report side effects directly via the national reporting system listed in Appendix V.
Danish: De eller Deres pårørende kan også indberette bivirkninger direkte til Lægemiddelstyrelsen via det nationale rapporteringssystem anført i Appendiks V. Ved at indrapportere bivirkninger kan De hjælpe med at fremskaffe mere information om sikkerheden af dette lægemiddel.
English: Pack size: 1 vial containing 2.5 mL or 5 mL of solution.
Danish: Pakningsstørrelse: 1 hætteglas med 2,5 ml eller 5 ml opløsning.
English: Name and address of the manufacturer(s) responsible for batch release CIS BIO International
Danish: Navn og adresse på den fremstiller (de fremstillere), der er ansvarlig(e) for batchfrigivelse
English: How Striascan is used
Danish: Sådan skal De bruge Striascan
English: Striascan 74 MBq /mL solution for injection.
Danish: Striascan 74 MBq/ml injektionsvæske, opløsning.
English: Driving and using machines It is considered unlikely that Striascan will affect your ability to drive or to use machines.
Danish: Det er ikke sandsynligt, at Striascan vil påvirke Deres evne til at føre motorkøretøj eller betjene maskiner.
English: The following undesirable effects are recognised for ioflupane (
Danish: Følgende bivirkninger kan forekomme med ioflupan (
English: Metal Box / Lead Pot - 2.5 mL presentation
Danish: Metalæske/Blybeholder - 2,5 ml pakningsstørrelse
English: Breastfeeding It is not known whether ioflupane (
Danish: Amning Det vides ikke, om ioflupan (
English: What Striascan contains - The active substance is ioflupane (
Danish: Striascan indeholder: - Aktivt stof: ioflupan (
English: It is not known whether ioflupane (
Danish: Det vides ikke, om det ioflupan (
English: Metal Box / Lead Pot - 5 mL presentation
Danish: Metalæske/Blybeholder - 5 ml pakningsstørrelse
English: Organ
Danish: Optagelse i organer
English: (1/10,000 to <1/1,000)
Danish: (1/10.000 til <1/1.000) Meget sjælden (<1/10.000) Ikke kendt
English: Manufacturer name address CIS bio international F-91192 GIF-SUR-YVETTE CEDEX
Danish: CIS bio international F-91192 GIF-SUR-YVETTE CEDEX
English: What Striascan is and what it is used for What you need to know before Striascan is used How Striascan is used
Danish: Det skal De vide, før De begynder at bruge Striascan Sådan skal De Striascan bruge Bivirkninger
English: 185 MBq / vial at ref. (see outer label) 74 MBq / mL
Danish: Volumen: 2,5 ml 185 MBq/hætteglas på ref. (se ydre etiket)
English: The sensitivity ranged from 60.6% to 63.4% and specificity from 88.6% to 91.4% when the possible DLB patients were included as DLB patients.
Danish: Når de mulige DLB-patienter blev inkluderet som DLB-patienter, varierede sensitiviteten mellem 60,6 % og 63,4 %, mens specificiteten varierede mellem 88,6 % og 91,4 %.
English: Ioflupane (
Danish: ioflupan (
English: ioflupane (
Danish: Ioflupan (
English: F-91192 Gif-sur-Yvette Cedex FRANCE
Danish: F-91192 Gif-sur-Yvette Cedex FRANKRIG
English: Vomiting
Danish: Vertigo
English: How Striascan is stored
Danish: Hvis De har fået for meget Striascan
English: This is about the same as 5 mL beer, or 2 mL wine.
Danish: Striascan indeholder 5 vol % alkohol, dvs. op til 197 mg pr. dosis, svarende til 5 ml øl eller 2 ml vin.
English: Vial - 2.5 mL presentation
Danish: Hætteglas - 2,5 ml pakningsstørrelse
English: - If you have any further questions, ask your nuclear medicine doctor who will supervise the procedure.
Danish: - Spørg den nuklearmedicinske læge, som overvåger undersøgelsen, hvis der er mere, De vil vide.
English: Vial - 5 mL presentation
Danish: Hætteglas - 5 ml pakningsstørrelse
English: Volume: 2.5 mL
Danish: Volumen: 2,5 ml 185 MBq/hætteglas
English: Gallbladder wall Gastrointestinal tract Stomach wall
Danish: Galdeblærevæg Mave-tarm-kanalen Mavevæg
English: Please refer to the SmPc.
Danish: Der henvises til produktresuméet.
English: 370 MBq / vial DD/MM/YYYY xx h xx CET 74 MBq / mL DD/MM/YYYY xx h xx CET
Danish: DD/MM/ÅÅÅÅ klokken xx:xx
English: The European Commission granted a marketing authorisation valid throughout the European Union for Zometa on 20 March 2001.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Zometa den 20. marts 2001.
English: Other information about Zometa
Danish: Andre oplysninger om Zometa
English: The full EPAR for Zometa can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Zometa findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: A risk management plan has been developed to ensure that Zometa is used as safely as possible.
Danish: Der er udarbejdet en risikostyringsplan for at sikre, at Zometa anvendes så sikkert som muligt.
English: This is a summary of the European public assessment report (EPAR) for Zometa.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Zometa.
English: The usual dose of Zometa is one infusion of 4 mg over at least 15 minutes.
Danish: Den normale dosis Zometa er én infusion på 4 mg over mindst 15 minutter.
English: What measures are being taken to ensure the safe and effective use of Zometa?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Zometa?
English: Zoledronic acid
Danish: Zoledronsyre
English: The CHMP decided that Zometa's benefits are greater than its risks and recommended that it be given marketing authorisation.
Danish: CHMP konkluderede, at fordelene ved Zometa er større end risiciene og anbefalede udstedelse af markedsføringstilladelse.
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Zometa.
Danish: Det forklarer, hvordan Udvalget for Lægemidler til Mennesker (CHMP) vurderede lægemidlet og nåede frem til sin udtalelse til fordel for udstedelse af en markedsføringstilladelse og til sine anbefalinger om, hvordan Zometa skal anvendes.
English: Zometa was compared with placebo (a dummy treatment) in two of the studies, and with pamidronate (another bisphosphonate) in the third.
Danish: Zometa blev sammenlignet med placebo (en uvirksom behandling) i to af undersøgelserne og med pamidronat (et andet bisphosphonat) i den tredje.
English: What is the risk associated with Zometa?
Danish: Hvilken risiko er der forbundet med Zometa?
English: In addition, the company that markets Zometa will provide a card to inform patients about the risk of osteonecrosis of the jaw and to instruct them to contact their doctor if they experience symptoms.
Danish: Virksomheden, som markedsfører Zometa, vil desuden udarbejde et patientkort med oplysninger om risikoen for osteonekrose i kæben og en instruks til patienter om at kontakte deres læge, hvis de oplever symptomer.
English: It is available as a powder (4mg) and solvent, and as a concentrate (4mg/5ml), both of which are made up into a solution for infusion (drip into a vein), and as a pre-prepared solution for infusion (4mg/100ml).
Danish: Det fås som et pulver (4 mg) og en solvens og som et koncentrat (4 mg/5 ml), begge til fremstilling af en opløsning til infusion (drop i en vene), og som en færdig opløsning til infusion (4 mg/100 ml).
English: For more information about treatment with Zometa, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Zometa, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Zometa, including the appropriate precautions to be followed by healthcare professionals and patients.
Danish: På baggrund af denne er der anført sikkerhedsoplysninger i produktresuméet og indlægssedlen for Zometa, herunder passende forholdsregler, som patienter og sundhedspersonale skal følge.
English: In the first two studies of patients with bone metastases, the number of patients who developed a new skeletal event was lower with Zometa (33 to 38%) than with placebo (44%).
Danish: I de to første undersøgelser af patienter med knoglemetastaser var antallet af patienter, som oplevede en ny knoglerelateret hændelse, mindre med Zometa (33-38 %) end med placebo (44 %).
English: The active substance in Zometa, zoledronic acid, is a bisphosphonate.
Danish: Det aktive stof i Zometa, zoledronsyre, er et bisphosphonat.
English: Zometa must only be used by a doctor who has experience in the use of this type of medicine given into a vein.
Danish: Zometa må kun anvendes af en læge med erfaring i brugen af denne type lægemiddel (som indgives i en vene).
English: In the third study, Zometa was as effective as pamidronate: 44% of the patients receiving Zometa had at least one skeletal event, compared with 46% of those receiving pamidronate.
Danish: I den tredje undersøgelse var Zometa lige så virksomt som pamidronat: 44 % af de patienter, som fik Zometa, oplevede mindst én knoglerelateret hændelse, sammenlignet med 46 % af dem, som fik pamidronat.
English: Zometa should not be used in pregnant or breastfeeding women.
Danish: Zometa bør ikke anvendes til behandling af gravide eller ammende.
English: The main measure of effectiveness was the number of patients whose calcium levels had returned to normal within 10 days after treatment.
Danish: Det primære mål for virkningen var antallet af patienter, hvis calciumindhold i blodet var vendt tilbage til det normale indhold inden 10 dage efter behandlingen.
English: Zometa can be used to prevent bone complications in adults with advanced cancer that is affecting the bone.
Danish: Zometa kan anvendes til forebyggelse af knoglekomplikationer hos voksne med fremskreden kræft, der påvirker knoglerne.
English: Why has Zometa been approved?
Danish: Hvorfor blev Zometa godkendt?
English: Zometa must not be used in people who are hypersensitive (allergic) to zoledronic acid, other bisphosphonates or any of the other ingredients.
Danish: Zometa må ikke anvendes hos patienter, der er overfølsomme (allergiske) over for zoledronsyre, andre bisphosphonater eller andre af indholdsstofferne.
English: By preventing the breakdown of bones, Zometa also helps to reduce the amount of calcium released into the blood.
Danish: Da Zometa forebygger nedbrydning af knoglerne, hjælper det også med at reducere den mængde calcium, der afgives til blodet.
English: Zometa has also been compared with pamidronate in two main studies involving a total of 287 adults with hypercalcaemia caused by tumours.
Danish: Zometa blev også sammenlignet med pamidronat i to hovedundersøgelser, der i alt omfattede 287 voksne med forhøjet calciumindhold i blodet som følge af svulster.
English: The main measure of effectiveness was the number of patients who developed at least one new ‘skeletal event' over 13 months.
Danish: Det primære mål for virkningen var antallet af patienter, som oplevede mindst én ny knoglerelateret hændelse i en periode på 13 måneder.
English: Osteonecrosis of the jaw (damage to the bones of the jaw, which could lead to pain, sores in the mouth or loosening of teeth) has been reported uncommonly (seen in between 1 and 10 patients in 1,000).
Danish: Der er rapporteret sjældne tilfælde af osteonekrose i kæben (beskadigelse af kæbebenene, der kan medføre smerter, sår i munden eller løse tænder) (hos mellem 1 og 10 patienter ud af 1 000).
English: This included any bone complications needing treatment with radiotherapy or surgery, any fractures or any spinal compression.
Danish: Det omfattede enhver form for knoglekomplikation, der krævede enten strålebehandling eller operation, enhver form for knoglebrud eller enhver forekomst af rygmarvskompression.
English: The most common side effect with Zometa (seen in more than 1 patient in 10) is hypophosphataemia (low blood phosphate levels).
Danish: Den hyppigste bivirkning ved Zometa (som optræder hos flere end 1 ud af 10 patienter) er et unormalt lavt indhold af fosfater i blodet.
English: For the full list of all side effects reported with Zometa, see the package leaflet.
Danish: Den fuldstændige liste over de indberettede bivirkninger ved Zometa fremgår af indlægssedlen.
English: Looking at the results of the two studies together, 88% of the patients receiving Zometa had normal calcium levels within 10 days after treatment, compared with 70% of those receiving pamidronate.
Danish: Når resultaterne af de to undersøgelser blev betragtet samlet, var calciumindholdet i blodet vendt tilbage til det normale indhold inden 10 dage efter behandlingen hos 88 % af dem, som havde fået Zometa, og hos 70 % af dem, som havde fået pamidronat.
English: In patients with hypercalcaemia, Zometa was more effective than pamidronate.
Danish: Hos patienterne med forhøjet calciumindhold i blodet var Zometa mere virksomt end pamidronat.
English: Zometa has been studied in over 3,000 adults with bone metastases in three main studies looking at its ability to prevent bone damage.
Danish: Der blev gennemført tre hovedundersøgelser med over 3 000 voksne med knoglemetastaser, hvor man undersøgte Zometas evne til at forebygge knogleskader.
English: How has Zometa been studied?
Danish: Hvordan blev Zometa undersøgt?
English: What is Zometa used for?
Danish: Hvad anvendes Zometa til?
English: What benefit has Zometa shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Zometa?
English: Zometa can also be used to treat the hypercalcaemia caused by tumours.
Danish: Zometa kan også anvendes til at behandle forhøjet calciumindhold i blodet, der skyldes svulster (tumorer).
English: How is Zometa used?
Danish: Hvordan anvendes Zometa?
English: How does Zometa work?
Danish: Hvordan virker Zometa?
English: In very rare cases a fatal outcome has been reported.
Danish: I meget sjældne tilfælde er der rapporteret om et fatalt udfald.
English: Protein binding was greater than 99.5%.
Danish: Proteinbindingen var højere end 99,5 %.
English: If a dose is forgotten, the following dose must not be increased.
Danish: Glemmes en dosis må den næste dosis ikke øges.
English: Do not use Avaglim after the expiry date shown on the pack.
Danish: Brug ikke Avaglim efter den udløbsdato, der står på pakningen.
English: Allergic reactions: These are very rare in people taking Avaglim.
Danish: Allergiske reaktioner: Disse forekommer meget sjældent hos personer, som tager Avaglim.
English: Premenopausal anovulatory women
Danish: Præmenopausale anovulatoriske kvinder