FrancophonIA/ELRC3.0 huggingface dataset:
English: may affect less than 1 in 10,000 users or frequency cannot be estimated from the available data - Blood in the urine (Haematuria) - Penile bleeding (Penile Haemorrhage) - Presence of blood in the semen (Haematospermia) - Sudden death - Bleeding in the brain
Danish: forekommer hos færre end 1 ud af 10.000 behandlede - Blod i urinen (hæmaturi) - Blødning fra penis - Blod i sæden - Pludselig død - Blødning i hjernen
English: Back pain Increase in creatine phosphokinase Myalgia
Danish: Rygsmerter Forhøjet kreatinfosfokinase
English: Vivanza orodispersible tablet is not for use in patients with end-stage renal failure (see section 4.3).
Danish: Vivanza smeltetablet må ikke anvendes til patienter med nyreinsufficiens i slutstadiet (se pkt.
English: When Vivanza film-coated tablets are taken with a high fat meal (containing 57% fat), the rate of absorption is reduced, with an increase in the median tmax of 1 hour and a mean reduction in Cmax of 20%.
Danish: Ved indgift af Vivanza filmovertrukne tabletter sammen med et fedtrigt måltid (indeholdende 57% fedt) reduceres absorptionshastigheden med en øgning af median Tmax på en time og en gennemsnitlig sænkning af Cmax på 20%.
English: may affect up to 1 in 100 users - Swelling of skin and mucous tissue including swollen face, lips or throat - Sleep disorder - Numbness and impaired perception of touch - Sleepiness - Effects on vision, redness of the eye, effects on colour vision, eye pain and discomfort, light sensitivity - Ringing in the ears, vertigo - Fast heart beat or pounding heart - Breathlessness - Stuffy nose - Acid reflux, gastritis, abdominal pain, diarrhoea, vomiting, feeling sick (nausea), dry mouth - Raised levels of liver enzymes in your blood - Rash, reddened skin - Back or muscle pain, increase in blood of a muscle enzyme (creatine phosphokinase), muscle stiffness - Prolonged erections - Malaise
Danish: forekommer hos op til 1 ud af 100 behandlede - Hævelser i hud og slimhinder, herunder hævelse i ansigt, læber eller hals - Søvnforstyrrelser - Følelsesløshed og nedsat fornemmelse af berøring - Søvnighed - Påvirkning af synet, røde øjne, ændret farvesyn, øjensmerter og -ubehag, lysfølsomhed - Ringen for ørerne, svimmelhed - Hurtig puls eller hjertebanken - Åndenød - Stoppet næse - Sure opstød, mavekatar, mavesmerter, diaré, opkastning, kvalme, tør mund - Forhøjede niveauer af leverenzymer i blodet - Udslæt, hudrødme - Ryg- og muskelsmerter, øget muskelenzym i blodet (kreatinfosfokinase), muskelstivhed - Vedvarende erektion - Ubehag
English: The maximum dose recommended in patients with moderate hepatic impairment (Child-Pugh B) is Vivanza 10 mg as film-coated tablets (see section 5.2).
Danish: Den anbefalede maksimale dosis hos patienter med moderat nedsat leverfunktion (Child-Pugh B) er Vivanza 10 mg som filmovertrukne tabletter (se pkt.
English: Vivanza 10 mg orodispersible tablets are not for use in patients with moderate (Child-Pugh B) and severe hepatic impairment (Child-Pugh C; see section 4.3).
Danish: Vivanza 10 mg smeltetabletter må ikke anvendes til patienter med moderat (Child-Pugh B) og stærkt nedsat leverfunktion (Child-Pugh C) (se pkt.
English: PDE5 inhibitors, such as Vivanza have been shown to increase the hypotensive effects of this medicine.
Danish: PDE5-hæmmere, så som Vivanza, har vist sig at øge den blodtrykssænkende virkning af denne medicin.
English: In patients with severe renal impairment (creatinine clearance <30 ml/min) a starting dose of Vivanza 5 mg film-coated tablets should be considered.
Danish: Hos patienter med stærk nedsat nyrefunktion (kreatininclearance <30 ml/min) bør en startdosis på Vivanza 5 mg filmovertrukne tabletter overvejes.
English: Tolerability of the maximum dose of Vivanza 20 mg film-coated tablets may be lower in elderly patients (≥65 years old) (see sections 4.2 and 4.8).
Danish: Tolerancen af den maksimale dosis på 20 mg filmovertrukne tabletter kan være lavere hos ældre patienter (≥65 år) (se pkt.
English: The interaction is a consequence of blocking hepatic metabolism of vardenafil by ritonavir, a highly potent CYP3A4 inhibitor, which also inhibits CYP2C9.
Danish: Ritonavir er en meget potent CYP3A4-inhibitor som også hæmmer CYP2C9.
English: Based on tolerability and efficacy, the dose may be increased to Vivanza 10 mg and 20 mg film-coated tablets, or Vivanza 10 mg orodispersible tablets.
Danish: Vurderet ud fra tolerance og virkning kan dosis øges til Vivanza 10 mg og 20 mg filmovertrukne tabletter eller Vivanza 10 mg smeltetabletter.
English: However, there is no information on the possible potentiation of the hypotensive effects of nitrates by vardenafil in patients, and concomitant use of Vivanza orodispersible tablets and nitrates is therefore contraindicated (see section 4.3).
Danish: Hos patienter findes der imidlertid ikke oplysninger om vardenafils mulige forstærkning af nitraters hypotensive effekt, og samtidig administration af Vivanza smeltetabletter og nitrater er derfor kontraindiceret (se pkt.
English: Increase in transaminases
Danish: Stigning i aminotransferaser
English: Other medicines and Vivanza
Danish: Brug af anden medicin sammen med Vivanza
English: Myocardial infarction Ventricular tachy-arrhythm ias
Danish: Myokardieinfarkt Ventrikulære takyarytmier Angina pectoris
English: Do not take Vivanza film-coated tablets with any other forms of Vivanza.
Danish: Tag ikke Vivanza filmovertrukne tabletter sammen med andre former for Vivanza.
English: This medicine contains 1.80 mg aspartame in each 10 mg orodispersible tablet.
Danish: Dette lægemiddel indeholder 1,80 mg aspartam pr. 10 mg smeltetablet.
English: However, an increase to a maximum dose of Vivanza 20 mg film-coated tablets should be carefully considered depending on the individual tolerability (see sections 4.4 and 4.8).
Danish: Dog bør en øgning til den maksimale dosis af Vivanza 20 mg filmovertrukne tabletter overvejes med forsigtighed i forhold til den enkelte patients tolerance over for lægemidlet (se pkt.
English: Vivanza 10 mg orodispersible tablets are not bioequivalent to Vivanza 10 mg film-coated tablets (see section 5.1).
Danish: Vivanza 10 mg smeltetabletter er ikke bioækvivalente med Vivanza 10 mg filmovertrukne tabletter (se pkt.
English: • When vardenafil (film-coated tablets) was given at doses of 5, 10 or 20 mg on a background of stable therapy with tamsulosin, there was no symptomatic reduction in blood pressure, although 3/21 tamsulosin treated subjects exhibited transient standing systolic blood pressures of less than 85 mmHg.
Danish: • Når vardenafil (filmovertrukne tabletter) blev givet i doser på 5, 10 eller 20 mg på baggrund af stabil behandling med tamsulosin, var der ingen symptomatisk reduktion i blodtrykket, selvom 3/21 patienter behandlet med tamsulosin havde forbigående systolisk blodtryk (stående) på mindre end 85 mmHg.
English: - Sorbitol: This medicine contains 7.96 mg sorbitol in each 10 mg orodispersible tablet.
Danish: - Sorbitol: Dette lægemiddel indeholder 7,96 mg sorbitol pr. 10 mg smeltetablet.
English: Vivanza 10 mg orodispersible tablets must be taken without liquid.
Danish: Vivanza 10 mg smeltetabletter skal tages uden væske.
English: Based on these results vardenafil 10 mg orodispersible tablets can be taken with or without food.
Danish: På basis af disse resultater kan vardenafil 10 mg smeltetabletter tages til måltiderne eller uden for måltiderne.
English: may affect up to 1 in 1,000 users - Inflammation of the eyes (conjunctivitis) - Allergic reaction - Anxiety - Fainting - Amnesia - Seizure - Increased pressure in the eye (glaucoma), lacrimation increased - Effects on the heart (such as heart attack, altered heart beat or angina) - High or low blood pressure - Nose bleed - Effect on results of blood tests to check liver function - Sensitivity of the skin to sun light - Painful erections - Chest pain - Temporarily decreased blood flow to parts of the brain
Danish: forekommer hos op til 1 ud af 1.000 behandlede - Øjenbetændelse (conjunktivitis) - Allergisk reaktion - Angst - Besvimelse - Hukommelsestab - Kramper - Øget tryk i øjet (glaukom), øget tåreflåd - Påvirkning af hjertet (f.eks. hjerteanfald, ændret hjerterytme eller hjertekramper (angina) - Højt eller lavt blodtryk - Næseblod - Indvirkning på resultaterne af blodprøver for leverfunktion - Øget hudfølsomhed over for sollys - Smertefulde erektioner - Smerter i brystet - Midlertidigt nedsat blodforsyning til dele af hjernen
English: Do not use Vivanza orodispersible tablets combined with any other treatment for erectile dysfunction, including Vivanza film-coated tablets.
Danish: Tag ikke Vivanza smeltetabletter sammen med anden behandling for erektil dysfunktion, herunder Vivanza filmovertrukne tabletter.
English: The safety and efficacy of combinations of Vivanza orodispersible tablets with film-coated tablets or other treatments for erectile dysfunction have not been studied.
Danish: Sikkerhed og virkning er ikke undersøgt ved kombination af Vivanza smeltetabletter og filmovertrukne tabletter eller med anden behandling af erektil dysfunktion.
English: Medicinal products that may prolong QTc interval, including vardenafil, are best avoided in patients with relevant risk factors, for example, hypokalaemia, congenital QT prolongation, concomitant administration of antiarrhythmic medicinal products in Class 1A (e.g. quinidine, procainamide), or Class III (e.g. amiodarone, sotalol).
Danish: Lægemidler, som kan forlænge QTc-intervallet, inklusive vardenafil, bør undgås hos patienter med relevante risikofaktorer, f.eks. hypokaliæmi, medfødt QTforlængelse, samtidig administration af klasse IA-antiarytmika (f.eks. quinidin, procainamid) eller klasse 3 (f.eks. amiodaron, sotalol).
English: Vivanza orodispersible tablets are not indicated for individuals below 18 years of age.
Danish: Vivanza smeltetablet er ikke indiceret til personer under 18 år.
English: - If you experience sudden decrease or loss of vision, stop taking Vivanza and contact your doctor immediately.
Danish: - Hvis De oplever pludselige nedsættelser af synet eller tab af synet, skal De stoppe med at tage
English: - If you are using any other treatments for erection difficulties, including Vivanza orodispersible tablets (see section Other medicines and Vivanza).
Danish: - Hvis De bruger andre lægemidler for erektionsproblemer, herunder Vivanza smeltetabletter (se afsnittet ”Brug af anden medicin sammen med Vivanza”.
English: - If you are using any other treatments for erection difficulties, including Vivanza film-coated tablets (see section Other medicines and Vivanza).
Danish: - Hvis De bruger andre lægemidler for erektionsproblemer, herunder Vivanza filmovertrukne tabletter (se pkt.
English: Do not use Vivanza film-coated tablets combined with any other treatment for erectile dysfunction, including Vivanza orodispersible tablets.
Danish: Tag ikke Vivanza filmovertrukne tabletter sammen med anden behandling for erektil dysfunktion, herunder Vivanza smeltetabletter.
English: The safety and efficacy of combinations of Vivanza film-coated tablets with Vivanza orodispersible tablets or other treatments for erectile dysfunction have not been studied.
Danish: Sikkerhed og virkning er ikke undersøgt ved kombination af Vivanza filmovertrukne tabletter og Vivanza smeltetabletter eller med anden behandling af erektil dysfunktion.
English: Based on these results Vivanza 10 mg orodispersible tablets can be taken with or without food.
Danish: På basis af disse resultater kan Vivanza 10 mg smeltetabletter tages til måltiderne eller uden for måltiderne.
English: Dyspepsia Gastro-oesophage al reflux disease Gastritis
Danish: Gastroøsofageal reflukssygdom Gastritis
English: Vivanza 10 mg orodispersible tablets are taken as needed approximately 25 to 60 minutes before sexual activity.
Danish: Anvendelse hos voksne mænd Vivanza 10 mg smeltetablet skal tages efter behov 25 til 60 minutter før seksuel aktivitet.
English: - Do not remove the orodispersible tablet from the blister until you are going to take it. With dry hands, press gently to release the tablet on your hand.
Danish: Træk med tørre hænder forsigtigt, så tabletten falder ned i Deres hånd.
English: Cardiac disorders
Danish: Deres elektrokardiogram.
English: In those patients who are stable on alpha-blocker therapy, vardenafil should be initiated at the lowest recommended starting dose of 5 mg film-coated tablets.
Danish: Hos de patienter, der er i stabil alfa-blokker behandling, bør vardenafil initieres med den laveste anbefalede startdosis på 5 mg filmovertrukne tabletter.
English: Increased muscle tone and cramping
Danish: Øget muskeltonus Muskelkramper
English: Vivanza can be taken with or without food.
Danish: Vivanza smeltetabletter kan tages i forbindelse med et måltid eller uden for måltiderne.
English: Headache Dizziness Somnolence Paraesthesia and dysaesthesia
Danish: Hovedpine Svimmelhed Døsighed Parastæsi og dysæstesi
English: Vivanza 5 mg film-coated tablets.
Danish: Vivanza 5 mg filmovertrukne tabletter.
English: Vivanza 20 mg film-coated tablets are orange with a ‘v' on one side and the strength (20) on the other side.
Danish: Vivanza 20 mg filmovertrukne tabletter er orange med ”v” på den ene side og styrken (20) på den anden side.
English: Vivanza is contraindicated in patients who have loss of vision in one eye because of non-arteritic anterior ischemic optic neuropathy (NAION), regardless of whether this episode was in connection or not with previous phosphodiesterase 5 (PDE5) inhibitor exposure (see section 4.4).
Danish: Vivanza er kontraindiceret til patienter, som på grund af non-arteritis anterior iskæmisk opticusneuropati (NAION) har nedsættelse af synet på det ene øje.
English: Vardenafil in film-coated tablets is metabolised predominantly by hepatic metabolism via cytochrome P450 (CYP) isoform 3A4 with some contribution from CYP3A5 and CYP2C isoforms.
Danish: Vardenafil i filmovertrukne tabletter metaboliseres hovedsagelig i leveren via cytokrom P450 (CYP)isoformen 3A4, men også via CYP3A5- og CYP2C-isoformer.
English: Vivanza 10 mg film-coated tablets are orange with a ‘v' on one side and the strength (10) on the other side.
Danish: Vivanza 10 mg filmovertrukne tabletter er orange med ”v” på den ene side og styrken (10) på den anden side.
English: EU/1/03/249/009 2 tablets EU/1/03/249/010 4 tablets EU/1/03/249/011 8 tablets EU/1/03/249/012 12 tablets EU/1/03/249/015 20 tablets
Danish: EU/1/03/249/009 2 tabletter EU/1/03/249/010 4 tabletter EU/1/03/249/011 8 tabletter EU/1/03/249/012 12 tabletter EU/1/03/249/015 20 tabletter
English: Vivanza 5 mg film-coated tablets are orange marked with a ‘v' on one side and the strength (5) on the other side.
Danish: Vivanza 5 mg filmovertrukne tabletter er orange med ”v” på den ene side og styrken (5) på den anden side.
English: EU/1/03/249/005 2 tablets EU/1/03/249/006 4 tablets EU/1/03/249/007 8 tablets EU/1/03/249/008 12 tablets EU/1/03/249/014 20 tablets
Danish: EU/1/03/249/005 2 tabletter EU/1/03/249/006 4 tabletter EU/1/03/249/007 8 tabletter EU/1/03/249/008 12 tabletter EU/1/03/249/014 20 tabletter
English: Jenapharm GmbH & Co. KG Tel: +49 (0)3641 64 8888
Danish: KG Tel: +49 (0)3641 64 8888
English: Increase in erection
Danish: Længerevarende erektioner
English: EU/1/03/249/001 2 tablets EU/1/03/249/002 4 tablets EU/1/03/249/003 8 tablets EU/1/03/249/004 12 tablets EU/1/03/249/013 20 tablets
Danish: EU/1/03/249/001 2 tabletter EU/1/03/249/002 4 tabletter EU/1/03/249/003 8 tabletter EU/1/03/249/004 12 tabletter EU/1/03/249/013 20 tabletter
English: Do not take Vivanza orodispersible tablets with any other forms of Vivanza.
Danish: Tag ikke Vivanza smeltetabletter sammen med andre former for Vivanza.
English: If you take more Vivanza than you should
Danish: Hvis De har taget for meget Vivanza
English: Vardenafil dose adjustment might be necessary if moderate CYP3A4 inhibitors such as erythromycin and clarithromycin, are given concomitantly (see sections 4.5 and 4.2).
Danish: Dosisjustering af vardenafil kan være nødvendig ved samtidig indgift af moderate CYP3A4-inhibitorer som erythromycin og clarithromycin (se pkt.
English: Vivanza 20 mg film-coated tablets vardenafil
Danish: Vivanza 20 mg filmovertrukne tabletter vardenafil
English: Vivanza 10 mg orodispersible tablets vardenafil
Danish: Vivanza 10 mg smeltetabletter vardenafil
English: Not known
Danish: Tag ikke
English: Vivanza 5 mg film-coated tablets vardenafil
Danish: Vivanza 5 mg filmovertrukne tabletter Vardenafil
English: Vivanza 10 mg film-coated tablets vardenafil
Danish: Vivanza 10 mg filmovertrukne tabletter vardenafil
English: Increase in gamma-glutamyl transferase
Danish: Stigning i gammaglutamyltransferase
English: Vivanza 20 mg film-coated tablets Orange round tablets marked with 'v' on one side and “20” on the other side.
Danish: Orange, runde tabletter, mærket med ”v” på den ene side og ”20” på den anden side.
English: Vardenafil
Danish: Crospovidon
English: With other alpha-blockers a time separation of dosing should be considered when vardenafil is prescribed concomitantly (see section 4.4).
Danish: Et doseringsinterval bør overvejes, hvis vardenafil ordineres samtidigt med andre alfa-blokkere(se pkt.
English: Priapism Penile Haemorrhage Haematosper mia
Danish: Nyrer og urinveje
English: Vivanza 10 mg film-coated tablets Orange round tablets marked with 'v' on one side and “10” on the other side.
Danish: Orange, runde tabletter, mærket med ”v” på den ene side og ”10” på den anden side.
English: Vivanza 5 mg film-coated tablets Orange round tablets marked with 'v' on one side and “5” on the other side.
Danish: Orange, runde tabletter, mærket med ”v” på den ene side og ”5” på den anden side.
English: Vivanza 10 mg orodispersible tablets
Danish: Vivanza 10 mg filmovertrukne tabletter
English: 2x (1 vial + 1 syringe + 1 needle + 1 vial adapter + 2 alcohol pads)
Danish: 2 x (1 hætteglas + 1 sprøjte + 1 kanyle + 1 hætteglasadapter + 2 spritservietter)
English: 1 pre-filled pen + 2 alcohol pads
Danish: 1 fyldt pen + 2 spritservietter
English: 1 pre-filled syringe + 2 alcohol pads
Danish: 1 fyldt injektionssprøjte + 2spritservietter
English: • if you are pregnant.
Danish: - hvis De er gravid.
English: Remaining organs Effective Dose
Danish: Resterende organer Effektiv dosis
English: I) at reference time.
Danish: I) på referencetidspunktet.
English: A minimum of 500 k counts should be collected for optimal images.
Danish: Der bør minimum optages 500 k counts for at opnå optimale billeder.
English: This can give the doctor valuable information about how that organ is working.
Danish: Dette kan give lægen værdifuld information om, hvordan organet fungerer.
English: Since this product is given by a doctor under controlled conditions, it is unlikely that you will get an overdose.
Danish: Eftersom dette lægemiddel gives af en læge under kontrollerede forhold, er det usandsynligt, at De vil få en overdosis.
English: Striascan will always be used in a hospital or a similar place.
Danish: Striascan vil altid blive anvendt på et hospital eller et lignende sted.
English: If you are pregnant, do not use Striascan.
Danish: Hvis De er gravid, brug ikke Striascan.
English: The rest is assumed to be distributed uniformly in the remaining organs and tissues.
Danish: Resten formodes at blive fordelt jævnt i de resterende organer og væv.
English: A scan will give your doctor information about any changes in this area of your brain.
Danish: En scanning vil give Deres læge information om enhver forandring i dette område af Deres hjerne.
English: They should tell you anything you need to do for the safe use of this medicine.
Danish: De vil fortælle Dem alt, hvad De skal gøre med henblik på sikker brug af denne medicin.
English: Individual benefit/risk justification
Danish: Individuel benefit/risk-evaluering
English: This scan will show exactly where the radioactivity is inside the organ and the body.
Danish: Dette scanningsbillede vil vise præcist, hvor radioaktiviteten befinder sig i organet eller i kroppen.
English: Ioflupane is a cocaine analogue.
Danish: Ioflupan er en cocain-analog.
English: Your doctor may feel that the scan would help in finding out more about your condition and deciding on possible treatment.
Danish: Deres læge kan vurdere, at scanningen kan bidrage til at finde ud af mere om Deres tilstand og til at træffe beslutning om mulig behandling.
English: The camera pictures are usually taken 3 to 6 hours after the injection of this product.
Danish: Kamerabillederne bliver normalt taget 3 til 6 timer efter injektionen af dette lægemiddel.
English: The doctor may ask you to stop taking them for a short time before you receive Striascan.
Danish: Lægen vil eventuelt bede Dem om at holde op med at tage dem i en kort periode, inden De får Striascan.
English: Contact your nuclear medicine doctor if you have any questions.
Danish: Kontakt den nuklearmedicinske læge, hvis De har nogen spørgsmål.
English: • parkinsonism (including Parkinson's disease) and
Danish: • parkinsonisme (herunder Parkinsons sygdom) og
English: You will need to be careful with the water (urine) that you pass - your doctor will tell you what to do.
Danish: De skal være påpasselig med den urin, som De udskiller i forbindelse med vandladning - Deres læge vil fortælle Dem, hvad De skal gøre.
English: Adverse reaction Preferred term
Danish: Bivirkninger Foretrukken term
English: Striascan is used only to identify illness.
Danish: Striascan bruges kun til at identificere sygdom.
English: It is important that you take the tablets or liquid as the doctor tells you.
Danish: Det er vigtigt, at De tager tabletterne eller væsken i henhold til lægens anvisninger.
English: For high resolution collimators the radius of rotation should be consistent and set as small as possible (typically 11-15 cm).
Danish: For højopløsningskollimatorer bør rotationsradius være overensstemmende og så lille som mulig (typisk 11 - 15 cm).
English: Radioactive medicine.
Danish: Radioaktivt lægemiddel.
English: For each patient, the radiation exposure must be justifiable by the likely benefit.
Danish: For hver patient skal strålingseksponeringen kunne berettiges af den sandsynlige fordel.
English: Your doctor and the nuclear medicine doctor have considered that the clinical benefit of this procedure with the radiopharmaceutical outweighs the risk of being exposed to these small amounts of radiation.
Danish: Deres læge og den nuklearmedicinske læge har vurderet, at de kliniske fordele ved denne undersøgelse med det radioaktive lægemiddel, overstiger risikoen ved at blive udsat for disse små mængder stråling.
English: This is normal practice with medicines like Striascan.
Danish: Dette er normal praksis for lægemidler som Striascan.
English: I) can be used as a surrogate marker to examine the integrity of the dopaminergic nigrostriatal neurons.
Danish: I) anvendes som surrogat-markør til undersøgelse af de dopaminerge nigrostratiale neuroners integritet.
English: I) results in an absorbed dose to the uterus of 2.6 mGy.
Danish: I) giver en absorberet dosis til uterus på 2,6 mGy.
English: I) at reference time (0.07 to 0.13 µg/mL of ioflupane).
Danish: I) på referencetidspunktet (0,07 til 0,13 μg ioflupan/ml).
English: I) (specific activity range 2.5 to
Danish: I) (specifikt aktivitetsinterval 2,5 til
English: • You should not breast-feed your child for 3 days after this product is given.
Danish: • De bør ikke amme Deres barn de første 3 dage efter, at du har fået dette lægemiddel.
English: Do not exceed 185 MBq and do not use when the activity is below 110 MBq.
Danish: Overstig ikke 185 MBq, og anvend ikke Striascan, hvis aktiviteten er under 110 MBq.
English: Animal reproductive toxicity studies have not been performed with this product.
Danish: Der er ikke udført reproduktionstoksicitetsstudier hos dyr med dette produkt.
English: • When a radiopharmaceutical is injected, it collects in a specific organ or area of the body for a short time.
Danish: • Når et radioaktivt lægemiddel injiceres, samler det sig sammen i et specifikt organ eller bestemte dele af kroppen i kort tid.
English: Marketing authorisation holder and manufacturer: CIS bio international
Danish: Indehaver af markedsføringstilladelsen og fremstiller: CIS bio international
English: Fertility No fertility studies have been performed.
Danish: Fertilitet Der er ikke udført fertilitetsstudier.