FrancophonIA/ELRC3.0 huggingface dataset:
English: 1 infusion bottle (type II glass) with a stopper (chlorobutyl elastomer) and a pure aluminium with internal and external lacquer flanged cap containing 65 ml solution for injection.
Danish: 1 infusionsflaske (glas type II) med en prop (chlorbutylelastomer) og en hætte med flange i rent aluminium lakeret udvendig og indvendig indeholdende 65 injektionsvæske, opløsning.
English: 1 vial (type II glass) with a stopper (chlorobutyl elastomer) and a pure aluminium with internal and external lacquer flanged cap containing 7.5 ml, 15 ml or 30 ml solution for injection.
Danish: 1 hætteglas (glas type I) med en prop (chlorbutylelastomer) og en hætte med flange i rent aluminium lakeret udvendig og indvendig, indeholdende 7,5 ml, 15 ml eller 30 ml injektionsvæske, opløsning.
English: Delayed reactions have been observed (after hours or days) (see section 4 “Possible Side Effects”).
Danish: Der er set eksempler på forsinkede reaktioner (efter timer eller dage) (se pkt.
English: One 20-ml prefilled syringe (type I glass) with a plunger stopper (chlorobutyl elastomer) and a tip cap (chlorobutyl elastomer) contains 20 ml solution for injection.
Danish: En 20 ml fyldt injektionssprøjte(glas type I) med en stempelprop (chlorbutyl elastomer) og en hætte på spidsen (chlorbutyl elastomer), indeholdende 20 ml injektionsvæske, opløsning.
English: Contrast enhanced MRI of liver or kidneys in patients with high suspicion or evidence of having focal lesions to classify these lesions as benign or malignant.
Danish: Kontrastforstærkning ved magnetisk resonans (MR) scanning af lever og nyrer hos patienter, hvor der er stærk mistanke om eller bevis på fokale læsioner, for at kunne klassificere disse læsioner som benigne eller maligne.
English: One 10-ml prefilled syringe (type I glass) with a plunger stopper (chlorobutyl elastomer) and a tip cap (chlorobutyl elastomer) contains 5 ml, 7.5 ml, 10 ml solution for injection.
Danish: En 10 ml fyldt injektionssprøjte(glas type I) med en stempelprop (chlorbutyl elastomer) og en hætte på spidsen (chlorbutyl elastomer), indeholdende 5 ml 7,5 ml, 10 ml injektionsvæske, opløsning.
English: MARKETING AUTHORISATION HOLDER [To be completed nationally]
Danish: INDEHAVER Af MARKEDSFØRINGSTILLADELSEN [Udfyldes nationalt]
English: 1 vial with 15 ml of the solution contains 9070 mg gadobutrol.
Danish: 1 hætteglas med 15 ml af opløsningen indeholder 9070 mg gadobutrol.
English: 1 or 5 prefilled syringes with 5, 7.5, 10 ml solution for injection (in 10-ml prefilled syringe) 1 or 5 prefilled syringes with 15 ml solution for injection (in 17-ml prefilled syringe) 1 or 5 prefilled syringes with 20 ml solution for injection
Danish: 1 eller 5 fyldte injektionssprøjter med 15, 17, 10 ml injektionsvæske, opløsning (i 17 ml fyldt injektionssprøjte)
English: Imaging of >1 field of view (FOV): 15 ml for body weight below 75 kg; 20 ml for body weight of 75 kg and higher (corresponding to 0.2-0.3 mmol/kg BW).
Danish: Scanning af > 1 FOV (field of view): 15 ml ved legemsvægt < 75 kg; 20 ml ved legemsvægt og højere 75 kg (svarende til 0,2 - 0,3 mmol/kg legemsvægt.)
English: One 17-ml prefilled syringe (type I glass) with a plunger stopper (chlorobutyl elastomer) and a tip cap (chlorobutyl elastomer) contains 15 ml solution for injection.
Danish: En 17 ml fyldt injektionssprøjte(glas type I) med en stempelprop (chlorbutyl elastomer) og en hætte på spidsen (chlorbutyl elastomer), indeholdende 15 ml injektionsvæske, opløsning.
English: Imaging of 1 field of view (FOV): 7.5 ml for body weight below 75 kg; 10 ml for body weight of 75 kg and higher (corresponding to 0.1-0.15 mmol/kg BW).
Danish: Scanning af 1 FOV (field of view): 7,5 ml ved legemsvægt < 75 kg; 10 ml ved legemsvægt og højere 75 kg (svarende til 0,1 - 0,15 mmol/kg legemsvægt.)
English: Rare (≥1/10,000 to
Danish: Sjælden (<1/10.000 til
English: NAME OF THE MEDICINAL PRODUCT Gadovist 1.0 mmol/ml solution for injection Gadobutrol
Danish: LÆGEMIDLETS NAVN Gadovist 1,0 mmol/ml injektionsvæske, opløsning Gadobutrol
English: 1 prefilled syringe with 15 ml of the solution contains 9070 mg gadobutrol.
Danish: 1 fyldt injektionssprøjte med 15 ml af opløsningen indeholder 9070 mg gadobutrol.
English: “Contrast enhanced MRI of liver or kidneys in patients with high suspicion or evidence of having focal lesions to classify these lesions as benign or malignant”.
Danish: "Kontrastforstærket MRI af lever eller nyrer hos patienter, hos hvilke fokale forandringer i lever eller nyrer er stærkt sandsynlige eller er påvist, med henblik på klassificering af sådanne forandringer som benigne eller maligne".
English: NAME OF THE MEDICINAL PRODUCT Gadovist 1.0 mmol/ml solution for injection
Danish: LÆGEMIDLETS NAVN Gadovist 1,0 mmol/ml injektionsvæske, opløsning
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Gadovist 1.0 mmol/ml solution for injection in prefilled syringe Gadobutrol
Danish: LÆGEMIDLETS NAVN, STYRKE OG ADMINISTRATIONSVEJ Gadovist 1,0 mmol/ml injektionsvæske, opløsning i fyldte injektionssprøjter Gadobutrol
English: Solution for Injection in prefilled syringe
Danish: Injektionsvæske (opløsning) i fyldt sprøjte
English: Below we list possible side effects by how likely they are, using the following categories: Uncommon: between 1 and 10 in every 1000 patients are likely to get these.
Danish: Bivirkningerne er opdelt i kategorier efter hvor sandsynlige de er:
English: Swelling (edema) of the face, Excessive sweating, Itching, Redness of the skin Fainting, Flushing
Danish: Åndedrætsbesvær (bronkospasme, hævelse af halsen), åndedrætsstop, blålige læber, hoste, nysen Hævelse (ødem) i ansigtet, unormalt stor svedafsondring, kløe, rødme i huden Besvimelse, rødme
English: Gadovist is not recommended for use in population below age 18 due to a lack of data on efficacy and safety.
Danish: På grund af manglende dokumentation for sikkerhed og/eller virkning bør Gadovist ikke anvendes til børn og unge under 18 år.
English: Vomiting
Danish: Svimmelhed
English: In addition, the following applies to use of the infusion bottle containing 65 ml: The contrast medium must be administered by means of an automatic injector.
Danish: Derudover gælder følgende for infusionsflasken indeholdende 65 ml:
English: Gadovist 1.0 mmol/ml, solution for injection, prefilled syringe
Danish: Gadovist 1,0 mmol/ml injektionsvæske, opløsning, fyldt injektionssprøjte
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE OF ADMINISTRATION Gadovist 1.0 mmol/ml solution for injection
Danish: LÆGEMIDLETS NAVN, STYRKE OG ADMINISTRATIONSVEJ Gadovist 1,0 mmol/ml injektionsvæske, opløsning Gadobutrol
English: Conjunctivitis, Swelling (edema) of the eyelid
Danish: Spin-spin relaksationstiden (T2) ca. 4 l mmol sek
English: Loss of consciousness, Convulsion
Danish: Besvimelsesanfald, krampeanfald
English: BATCH NUMBER Lot {number} GENERAL CLASSIFICATION FOR SUPPLY [To be completed nationally]
Danish: FREMSTILLERENS BATCHNUMMER Lotnummer {nummer}
English: If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or radiologist.
Danish: Tal med lægen eller radiologen, hvis en bivirkning bliver værre, eller du får bivirkninger, som ikke er nævnt her.
English: NAME OF THE MEDICINAL PRODUCT Gadovist 1.0 mmol/ml solution for injection in prefilled syringe Gadobutrol
Danish: Gadovist 1,0 mmol/ml injektionsvæske, opløsning i fyldte injektionssprøjter Gadobutrol
English: These measures will help protect the environment.
Danish: Disse foranstaltninger skal hjælpe med til at beskytte miljøet.
English: Follow the instructions carefully.
Danish: Følg instruktionerne nøje.
English: This does not rule out more direct countermeasures.
Danish: Dette udelukker ikke mere direkte forholdsregler.
English: The Educational material shall contain the following key messages:
Danish: Undervisningsmaterialet skal indeholde følgende nøgleoplysninger:
English: Only 2 % of the dose is excreted in unchanged form.
Danish: Kun 2 % af dosis udskilles i uændret form.
English: - Inform about the indication and how to appropriately select patients;
Danish: - Oplysning om indikation og om korrekt udvælgelse af patienter;
English: Appropriate measures should be taken to maintain stable arterial pressure.
Danish: Der bør tages relevante forholdsregler for at opretholde et stabilt, arterielt tryk.
English: Patients with BMI > 30 kg/m
Danish: Patienter med BMI > 30 kg/m
English: Zalviso was also considered to be easier to use by healthcare professionals (P = 0.017).
Danish: Zalviso blev også betragtet som nemmere at bruge af sundhedspersonale (p = 0,017).
English: Zalviso with alcohol
Danish: Zalviso sammen med alkohol
English: Any other waste material must be discarded in accordance to the institutional policies and local requirements.
Danish: Andet affald skal bortskaffes i henhold til institutionens politikker og lokale regler.
English: • Educational materials for the healthcare professionals
Danish: • Undervisningsmateriale til sundhedspersonalet
English: Hypnotic activity can be demonstrated by EEG alterations.
Danish: Hypnotisk aktivitet kan påvises ved EEG-ændringer.
English: Abuse potential and tolerance
Danish: Misbrugspotentiale og tolerance
English: The device will work for 3 days (72 hours), which is also the maximum recommended duration of your treatment.
Danish: Udstyret virker i 3 dage (72 timer), som også er den maksimale, anbefalede varighed af behandlingen.
English: It could be helpful to inform friends or relatives to be aware of the signs and symptoms stated above.
Danish: Det kan være en hjælp at fortælle venner og familie om, at de skal være opmærksomme på ovenstående tegn og symptomer.
English: The device should be used as recommended in the information provided by the device manufacturer.
Danish: Udstyret skal anvendes i henhold til anbefalingerne i informationen fra producenten.
English: See section “Method of administration”.
Danish: Se afsnit “Administration”.
English: After receiving a dose you will not be able to release another dose for 20 minutes and you will not be able to take more than 3 doses in one hour.
Danish: Efter at have fået en dosis kan du ikke udløse endnu en dosis i 20 minutter, og du kan ikke tage mere end 3 doser på én time.
English: België/Belgique/Belgien Luxemburg/Luxembourg S.A. Grünenthal N.V.
Danish: België/Belgique/Belgien Luxembourg/Luxemburg S.A. Grünenthal N.V.
English: All effects of sufentanil can immediately and completely be blocked by administration of a specific antagonist such as naloxone.
Danish: Alle sufentanils virkninger kan blokeres omgående og fuldstændigt ved administration af en specifik antagonist som naloxon.
English: * see “Description of selected adverse reactions”
Danish: * se “Beskrivelse af udvalgte bivirkninger”
English: In clinical trials during repeated administrations the bioavailability decreased to 37.6 %.
Danish: I kliniske forsøg under gentagne administrationer aftog biotilgængeligheden til 37,6 %.
English: Local tolerance
Danish: Lokal tolerance
English: Talk to your doctor or nurse if you did not fully understand the instructions or are unsure about the correct handling of the administration device.
Danish: Tal med din læge eller sygeplejerske, hvis du ikke forstår instrukserne fuldt ud eller ikke er sikker på, hvordan du skal håndtere doseringsudstyret korrekt.
English: In that case, the opioid antagonist can be administered repeatedly or by infusion.
Danish: I dette tilfælde kan opioid-antagonisten gives gentagne gange eller via infusion.
English: You can control your treatment and should only activate the device when in need of pain relief.
Danish: Du kan kontrollere din behandling og bør kun aktivere udstyret, når du har brug for smertelindring.
English: The patients should be followed closely for signs and symptoms of respiratory depression and sedation.
Danish: Patienterne skal overvåges nøje for tegn og symptomer på respirationsdepression og sedation.
English: Sufentanil was not teratogenic in rats and rabbits.
Danish: Sufentanil var ikke teratogen hos rotter og kaniner.
English: Do not use this medicine after the expiry date which is stated on the carton and sachet after EXP.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på pakningen og posen efter EXP.
English: Based on the combined safety data from these clinical studies, nausea and vomiting were the most frequently reported adverse reactions (≥1/10 frequency).
Danish: Baseret på de kombinerede sikkerhedsdata fra disse kliniske studier var kvalme og opkastning de hyppigst rapporterede bivirkninger (hyppighed ≥ 1/10).
English: OUTER CARTON for 1, 10 and 20 cartridges
Danish: YDERKARTON for 1, 10 og 20 patroner
English: Primary attention should be given to obstruction of airways and the necessity of assisted or controlled ventilation.
Danish: Det primære fokus bør være på eventuel obstruktion af luftveje og nødvendigheden af assisteret eller kontrolleret ventilation.
English: Children and adolescents Zalviso should not be used in children and adolescents below 18 years.
Danish: Børn og unge Zalviso må ikke anvendes af børn og unge under 18 år.
English: You should not eat or drink and should talk as little as possible for 10 minutes after each dose.
Danish: Du må ikke spise eller drikke og bør tale så lidt som muligt i 10 minutter efter hver dosis.
English: You will then be able to take a tablet as needed to relieve your pain.
Danish: Derefter kan du tage en resoriblet efter behov for at lindre dine smerter.
English: The device is constructed so that you will not be able to open it.
Danish: Doseringsudstyret er designet på en måde, så du ikke kan åbne det.
English: - Use Zalviso according to the guidance in the SmPC to ensure appropriate use and minimize risks.
Danish: - Anvendelse af Zalviso i overensstemmelse med vejledningen i produktresuméet (SmPC) for at sikre korrekt anvendelse og minimere risici.
English: It was concluded from these studies that Zalviso sublingual tablets have no or minimal potential for local irritation.
Danish: Disse studier viste, at Zalviso sublinguale resoribletter ikke har nogen eller kun minimal risiko for lokal irritation.
English: Because of these risks, concomitant prescribing with these sedating medicinal products should be reserved for patients for whom alternative treatment options are not possible.
Danish: På grund af disse risici bør samtidig ordination af disse sedativa forbeholdes patienter, som ikke har alternative behandlingsmuligheder.
English: - if you have severe breathing problems.
Danish: - hvis du har svære åndedrætsproblemer.
English: Sufentanil crosses the placenta.
Danish: Sufentanil krydser placenta.
English: Interaction with other sublingually administered products or products intended to dilute/establish an effect in the oral cavity were not evaluated and simultaneous administration should be avoided.
Danish: Interaktion med andre sublingualt administrerede produkter eller produkter, der er beregnet til at opløses/etablere en effekt i mundhulen, er ikke undersøgt, og samtidig administration bør undgås.
English: It can increase the risk of experiencing severe breathing problems.
Danish: Det kan give øget risiko for svære åndedrætsproblemer.
English: The total plasma clearance after single intravenous administration is about 917 l/min.
Danish: Den totale plasmaclearance efter en enkelt, intravenøs administration er cirka 917 l/min.
English: Because of this, concomitant use should only be considered when other treatment options are not possible.
Danish: Derfor bør samtidig brug kun overvejes, når der ikke findes andre behandlingsmuligheder.
English: OUTER LABEL (WITH BLUE BOX) MULTIPACKS ONLY
Danish: YDRE ETIKET (MED BLUE BOX) KUN MULTIPAKNING
English: INTERMEDIATE CARTON COMPONENT OF A MULTIPACK (WITHOUT BLUE BOX)
Danish: INDRE KARTON SOM DEL AF EN MULTIPAKNING (UDEN BLÅ BOKS)
English: EXP see page 1 EXP see reverse
Danish: EXP, se side 1 EXP, se bagsiden
English: Similar effects with other potent CYP3A4 inhibitors (e. g. itraconazol, ritonavir) cannot be excluded.
Danish: Lignende virkninger med andre potente CYP3A4-inhibitorer (f.eks. itraconazol, ritonavir) kan ikke udelukkes.
English: Only patients who are able to understand and follow the instructions to operate the administration device should use Zalviso.
Danish: Kun patienter, som kan forstå og følge instruktionerne til betjening af doseringsudstyret, bør bruge Zalviso.
English: Very common side effects (may affect more than 1 in 10 people): nausea, vomiting, fever.
Danish: Meget almindelige bivirkninger (forekommer hos mere end 1 ud af 10 personer): kvalme, opkastning, feber.
English: Any change in efficacy/tolerability associated with the increased exposure would be compensated in practice by an alteration in dosing frequency (see section 4.2).
Danish: Eventuelle ændringer i effekt/tolerabilitet, der er forbundet med øget eksponering, vil i praksis blive kompenseret ved en ændring i doseringsfrekvensen (se pkt.
English: Approximately 80 % of the intravenously administered dose of sufentanil is excreted within 24 hours.
Danish: Cirka 80 % af den intravenøst administrerede dosis sufentanil udskilles inden for 24 timer.
English: The population pharmacokinetic analysis showed an effect of age with a 27 % decrease in clearance in the elderly people (above 65 years of age).
Danish: Den farmakokinetiske populationsanalyse viste en aldersmæssig effekt med 27 % fald i clearance hos ældre (over 65 år).
English: Blood pressure increased Blood pressure decreased
Danish: Forhøjet blodtryk Nedsat blodtryk
English: Contact your doctor when experiencing such symptoms.
Danish: Kontakt din læge, hvis du får nogen af disse symptomer.
English: Please tell your doctor about all sedating medicines you are taking, and follow your doctor's dose recommendation closely.
Danish: Fortæl din læge om alle de typer beroligende medicin du tager, og følg nøje lægens anbefalede dosering.
English: Lot see page 1 Lot see reverse
Danish: Lot, se side 1 Lot, se bagsiden
English: Biotransformation takes place primarily in the liver and the small intestine.
Danish: Biotransformation sker primært i leveren og i tyndtarmen.
English: - Any medicines to treat anxiety, tranquillisers or other opioid medicines, as they can increase the risk of severe breathing problems.
Danish: - Et hvilket som helst lægemiddel til behandling af angst, beroligende midler eller andre opioide lægemidler, da de kan øge risikoen for svære åndedrætsproblemer.
English: Additional Zalviso cartridges may be utilized if needed.
Danish: Yderligere Zalviso-patroner kan anvendes ved behov.
English: It is not recommended to use these medicines at the same time as Zalviso.
Danish: Det anbefales ikke at bruge disse lægemidler samtidig med Zalviso.
English: There are no indications to date that the use of sufentanil during pregnancy increases the risk of congenital abnormalities.
Danish: Der er til i dag ingen indikationer på, at anvendelsen af sufentanil under graviditet øger risikoen for medfødte abnormiteter.
English: Population pharmacokinetic analysis with a BMI as covariate showed that patients with a BMI > 30 kg/m2 dosed more frequently.
Danish: Farmakokinetisk populationsanalyse med BMI som covariat viste, at patienter med et BMI > 30 kg/m kræver hyppigere dosering.
English: The shorter duration of activity of the opiate antagonist compared to sufentanil should be taken into account.
Danish: Opiat-antagonistens kortere aktivitet i forhold til sufentanil bør tages i betragtning.
English: The safety and efficacy in elderly patients was similar to that observed in younger adults (see section 5.2).
Danish: Sikkerhed og effekt hos ældre patienter var på samme niveau som observeret hos yngre voksne (se pkt.
English: Management of overdose should be focused on treating symptoms of µ-opioid receptor agonism including administration of oxygen.
Danish: Håndtering af en overdosis bør fokusere på behandling af symptomer på µ-opioid receptoragonisme, herunder administration af ilt.
English: There are no data on the effects of sufentanil on fertility in women or men.
Danish: Der foreligger ingen data om effekten af sufentanil på fertiliteten hos kvinder eller mænd.
English: The embryolethal effect was considered secondary to the toxicity for the mother animal.
Danish: Den embryoletale effekt blev anset for sekundær i forhold til toksiciteten for moderdyret.
English: In humans the potency is 7 to 10-fold higher than fentanyl and 500 to 1,000-fold higher than morphine (per oral).
Danish: Hos mennesker er styrken 7-10 gange højere end fentanyl og 500-1.000 gange højere end morfin (peroralt).
English: Sufentanil caused embryolethality in rats and rabbits who were treated for 10-30 days during pregnancy with 2.5 times the maximum human dose by intravenous administration.
Danish: Sufentanil forårsagede embryoletalitet hos rotter og kaniner, der blev behandlet i 10-30 dage under drægtighed med 2,5 gange den maksimale, humane dosis ved intravenøs administration.
English: Do not drink alcohol while using Zalviso.
Danish: Du må ikke drikke alkohol, når du tager Zalviso.
English: No negative effects were observed in another study in rats that were treated with 20times the maximum human dose in the period of organogenesis.
Danish: Der blev ikke iagttaget bivirkninger i et andet studie hos rotter, der blev behandlet med 20 gange den maksimale, humane dosis i organdannelsesperioden.
English: An opiate antagonist (e.g. naloxone) should be administered in the event of respiratory depression.
Danish: En opiat-antagonist (f.eks. naloxon) bør gives i tilfælde af hæmmet respiration.
English: In particular, tell your doctor if you are taking any of the following: - Any medicines that might have an effect on the way in which your body breaks down Zalviso e.g. ketoconazole, which is used for the treatment of fungal infections.
Danish: Du skal i særdeleshed fortælle det til lægen, hvis du tager et af de følgende lægemidler: - Et hvilket som helst lægemiddel, der kan påvirke den måde, din krop nedbryder Zalviso, f.eks. ketoconazol, som anvendes til behandling af svampeinfektioner.
English: Sufentanil does not induce histamine release.
Danish: Sufentanil inducerer ikke histaminfrigivelse.
English: Therefore, it should be used with caution in patients with previous or pre-existing bradyarrhythmias.
Danish: Det bør derfor anvendes med forsigtighed hos patienter med tidligere eller eksisterende bradyarytmier.
English: The preclinical effects were only observed following administrations of levels significantly above the maximum human dose, which are therefore of little relevance for clinical use.
Danish: De prækliniske effekter blev kun observeret efter administrationsniveauer signifikant over den maksimale, humane dosis, og de har derfor kun beskeden relevans til klinisk anvendelse.
English: There is insufficient data on the use of sufentanil during human pregnancy to evaluate its potential harmful effects.
Danish: Der foreligger kun utilstrækkelige data om brugen af sufentanil under human graviditet til at vurdere potentielle, skadelige virkninger.
English: If a decision is made to prescribe Zalviso concomitantly with sedating medicinal products the duration of the concomitant treatment should be as short as possible.
Danish: Hvis det besluttes at ordinere Zalviso samtidig med sedativa, skal varigheden af den samtidige behandling være så kort som muligt.
English: This compares to a substantially lower bioavailability of 9 % after oral intake (swallowed).
Danish: Det viser en væsentligt lavere biotilgængelighed på 9 % efter oral indtagelse (sunket).
English: When Zalviso was administered every 20 minutes, steady state plasma concentrations were achieved after 13 doses.
Danish: Når Zalviso blev administreret hvert 20. minut, blev konstante plasmakoncentrationer nået efter 13 doser.
English: Since this decrease related to age is smaller than the observed inter-subject variability of 30-40 % in exposure parameters for sufentanil, this effect is not considered to be of clinical relevance, particularly given that Zalviso is only used on an ‘as-needed' basis.
Danish: Da dette fald i relation til alder er mindre end den observerede variabilitet imellem forsøgspersoner på 30-40 % i sufentanils eksponeringsparametre, betragtes effekten ikke som klinisk relevant, særligt da Zalviso kun anvendes efter behov.