FrancophonIA/ELRC3.0 huggingface dataset:
English: Content of the pack and other information
Danish: 6 Pakningsstørrelser og yderligere oplysninger
English: Studies in rats have shown reproductive toxicity (see section 5.3).
Danish: Rottestudier har påvist reproduktionstoksicitet (se pkt.
English: • pelvic pain, discharge, itching or pain in the vagina
Danish: • bækkensmerter, udflåd, kløe eller smerter i vagina
English: Then you can have your first food and drink and and take any medicines or supplements
Danish: Derefter kan De indtage dagens første mad og drikke samt tage medicin, vitaminer og mineraler eller kosttilskud..
English: You can drive and use machines as it's expected that Iasibon has no or negligible effect on your ability to drive and use machines.
Danish: Du kan køre bil og betjene maskiner, da det forventes at Iasibon ikke eller kun i ubetydelig grad påvirker din evne til at køre bil og betjene maskiner.
English: Albumin-corrected Serum calcium (mmol/l)
Danish: Albuminkorrigeret serum-calcium ( mmol/l)
English: A flu-like syndrome consisting of fever, chills, bone and/or muscle ache-like pain has occurred.
Danish: En influenzalignende tilstand med feber, kuldegysninger, knogle og/eller muskelsmerter er set.
English: Neoplasms benign, malignant, and unspecified
Danish: Benigne, maligne og uspecificerede tumorer (inkl.
English: This is because aminoglycosides and Iasibon can both lower the amount of calcium in your blood.
Danish: Aminoglykosider og Iasibon kan begge nedsætte mængden af kalk i dit blod.
English: In most patients with severe hypercalcaemia (albumin-corrected serum calcium* ≥3 mmol/l or
Danish: Hos de fleste patienter med alvorlig hyperkalcæmi (albuminkorrigeret serum-calcium* ≥3 mmol/l eller
English: The most serious reported adverse reactions are anaphylactic reaction/shock, atypical fractures of the femur, osteonecrosis of the jaw, gastrointestinal irritation, and ocular inflammation (see paragraph “Description of selected adverse reactions” and section 4.4).
Danish: De alvorligste bivirkninger indrapporteret er anafylaktisk reaktion/shock, atypiske femurfrakturer, knoglenekrose i kæben, gastrointestinal irritation og inflammation i øjet (se afsnit ”Beskrivelse af udvalgte bivirkninger” og pkt.
English: The recommended dose for prevention of skeletal events in patients with breast cancer and bone metastases is 6 mg intravenous injection given every 3-4 weeks.
Danish: Den anbefalede dosis ved forebyggelse af knoglerelaterede hændelser hos patienter med brystkræft og knoglemetastaser er 6 mg intravenøs injektion hver 3-4 uge.
English: • Treatment of tumour-induced hypercalcaemia - added to 500 ml isotonic sodium chloride solution or 500 ml 5% dextrose solution and infused over 2 hours
Danish: • Behandling af tumorinduceret hyperkalcæmi - tilsættes til 500 ml isotonisk natriumchloridinfusionsvæske eller 500 ml 5 % glucoseinfusionsvæske og infunderes over 2 timer.
English: • if you have high or low blood levels of vitamin D or any other minerals
Danish: • hvis De har forhøjet eller nedsat indhold af vitamin D eller andre mineraler i blodet.
English: Adverse effects of ibandronic acid in reproductive toxicity studies in the rat were those expected for this class of medicinal products (bisphosphonates).
Danish: Bivirkningerne af ibandronsyre hos rotter i reproduktionstoksicitetsstudierne var de samme som forventet for bisphosphonatklassen.
English: - Hypersensitivity to ibandronic acid or to any of the excipients listed in section 6.1.
Danish: - Overfølsomhed over for ibandronsyre eller over for et eller flere af hjælpestofferne anført i pkt 6.1.
English: Chest pain, influenzalike illness, malaise, pain
Danish: Brystsmerter, influenzalignende sygdom, utilpashed, smerter
English: Hypocalcae mia**
Danish: Hypo-kalcæmi**
English: • persistent eye pain and inflammation
Danish: • vedvarende smerte og betændelse i øjet.
English: Since both the kidney and the liver were found to be target organs for toxicity in preclinical studies with high doses, kidney and liver function should be monitored.
Danish: Da man i forsøg med dyr med høje doser har konstateret, at både nyren og leveren er målorganer for toksiciteten, bør nyre- og leverfunktion overvåges.
English: To avoid potential incompatibilities Iasibon concentrate for solution for infusion should only be diluted with isotonic sodium chloride solution or 5% glucose solution.
Danish: For at undgå potentielle uforligeligheder, skal Iasibon koncentrat til infusionsvæske, opløsning kun blandes med isotonisk natriumchlorid eller med 5 % glucoseinfusionsvæske.
English: Osteonecrosis of the jaw is generally associated with tooth extraction and / or local infection (including osteomyelitis).
Danish: Knoglenekrose i kæben er normalt forbundet med tandudtrækning og/eller lokal infektion (herunder osteomyelitis).
English: Bone resorption due to malignant disease is characterised by excessive bone resorption that is not balanced with appropriate bone formation.
Danish: Knogleresorptionen ved malign sygdom karakteriseres ved en udtalt knogleresorption som ikke modsvares af en tilsvarende knogleformation.
English: Skin disorder, ecchymosis
Danish: Hudlidelser, ekkymose
English: Pooled data from these studies demonstrated a significant advantage for Ibandronate 50 mg p.o. over placebo in the reduction in SREs measured by the SMPR (p=0.041).
Danish: Sammenfattende resultater fra disse undersøgelse viste en signifikant fordel for ibandronsyre 50 mg p.o. frem for placebo, til reduktion af SREs målt ved den tidsjusterede SMPR (p=0,041).
English: • stomach and tummy pain, indigestion, being sick vomiting or having diarrhoea (loose bowels)
Danish: • mavesmerter, fordøjelsesbesvær, kvalme, opkastning eller diarré (løs mave)
English: Nevertheless, according to clinical assessment of the individual patient, it is recommended that renal function, serum calcium, phosphate and magnesium should be monitored in patients treated with Iasibon .
Danish: I overensstemmelse med individuel klinisk vurdering anbefales det dog alligevel at kontrollere nyrefunktionen, serum-calcium, phosphat og magnesium hos patienter i Iasibon-behandling.
English: In order to avoid potential incompatibilities Iasibon concentrate for solution for infusion should only be diluted with isotonic sodium chloride solution or 5% dextrose solution.
Danish: For at undgå potentielle uforligeligheder bør Iasibon koncentrat til infusionsvæske, opløsning kun fortyndes med isotonisk natriumchloridinfusionsvæske eller 5 % glucoseinfusionsvæske.
English: • tooth problems.
Danish: • tandproblemer
English: See also dosage section above for patients with renal impairment
Danish: Se også afsnittet ovenfor vedrørende dosering af patienter med nedsat nyrefunktion.
English: Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder Pharmathen S.A.
Danish: Indehaver af markedsføringstilladelsen og fremstiller Indehaver af markedsføringstilladelsen Pharmathen S.A.
English: Immune system disorders
Danish: Immun-systemet
English: • low calcium or phosphate levels in your blood
Danish: • lavt indhold af kalk eller fosfat i blodet
English: EXPIRY DATE
Danish: 3 UDLØBSDATO EXP
English: Parathyroid disorder
Danish: Parathyroideasygdomme
English: • a heart rhythm problem called ‘bundle branch block'
Danish: • hjerteproblem kaldet grenblok
English: Very rare (may affect up to 1 in 10,000 people)
Danish: Meget sjælden (kan forekomme hos 1 ud af 10.000 behandlede)
English: This is because it can cause irritation, inflammation or ulcers in your food pipe/gullet (oesophagus).
Danish: Det er fordi, der kan forekomme irritation, betændelse eller sårdannelse i spiserøret.
English: 10vials
Danish: 10 hætteglas
English: • aching joints, arthritis, or other joint problems
Danish: • ledsmerter, ledbetændelse eller andre ledproblemer
English: Take your tablet at least 6 hours after you had last had anything to eat, drink or any other medicines or supplements except water.
Danish: Indtag Iasibon mindst 6 timer efter, at du sidst har spist, drukket eller taget nogen form for anden medicin, vitaminer og mineraler eller kosttilskud andet end vand.
English: If you are taking a tablet each day, skip the missed dose completely.
Danish: Hvis De tager én tablet hver dag, spring da den glemte tablet over og fortsæt som normalt den næste dag.
English: • if you have high or low levels of vitamin D, calcium or any other minerals
Danish: • hvis De har forhøjet eller nedsat indhold af vitamin D, kalk eller andre mineraler i blodet.
English: If you have been told by your doctor that you cannot tolerate or digest some sugars (e.g. if you have a galactose intolerance, the Lapp lactase deficiency or have problems with glucose-galactose absorption), talk to your doctor before taking this medicine.
Danish: Kontakt lægen, før du tager denne medicin, hvis lægen har fortalt dig, at du ikke tåler eller kan fordøje visse sukkerarter (f.eks. hvis du lider af galactoseintolerans, LAPP lactasemangel eller har problemer med glucose/galaktose optagelse).
English: Posology Prevention of skeletal events in patients with breast cancer and bone metastases
Danish: Kliniske studier ved forebyggelse af knoglerelaterede hændelser hos patienter med brystkræft og knoglemetastaser
English: Children and adolescents Iasibon should not be used in children and adolescents below the age of 18 years.
Danish: Børn og unge Iasibon bør ikke anvendes til børn og unge under 18 år.
English: Keep taking Iasibon for as long as your doctor tells you.
Danish: Det er vigtigt, at De anvender Iasibon så længe, Deres læge har ordineret det. Iasibon kan kun afhjælpe Deres tilstand så længe, De fortsætter med at anvende det.
English: There is no meaningful reduction in bioavailability provided ibandronic acid is taken 60 minutes before a meal.
Danish: Ved indtagelse 30 minutter før et måltid er reduktionen i biotilgængelighed ca. Der er ingen relevant nedsættelse af biotilgængeligheden, når ibandronsyre indtages 60 minutter før et måltid.
English: A 15 minute infusion time has not been studied in cancer patients with a creatinine clearance of <50 ml/min.
Danish: Der er ikke foretaget studier med en infusionstid på 15 minutter hos kræftpatienter med kreatininclearance < 50 ml/min.
English: Asthma exacerbation
Danish: Astmaeksacerbation
English: • Prevention of Skeletal Events - added to 100 ml isotonic sodium chloride solution or 100 ml 5% dextrose solution and infused over at least 15 minutes.
Danish: • Forebyggelse af knoglerelaterede hændelser - tilsættes til 100 ml isotonisk natriumchloridinfusionsvæske eller 100 ml 5 % glucoseinfusionsvæske og infunderes over mindst 15 minutter.
English: Ocular inflammation events such as uveitis, episcleritis and scleritis have been reported with ibandronic acid.
Danish: Inflammation i øjet, såsom uveitis, episcleritis og scleritis er blevet rapporteret ved brug af ibandronsyre.
English: Ocular inflammation Ocular inflammation events such as uveitis, episcleritis and scleritis have been reported with ibandronic acid.
Danish: Inflammation i øjet Inflammation i øjet såsom uveitis, episcleritis og scleritis er blevet rapporteret ved brug af ibandronsyre.
English: Prevention of skeletal events in patients with breast cancer and bone metastases with Ibandronate 50 mg tablets was assessed in two randomized placebo controlled phase III trials with a duration of 96 weeks.
Danish: Forebyggelse af knoglerelaterede hændelser hos patienter med brystkræft og knoglemetastaser med ibandronsyre 50 mg tabletter, blev vurderet i to randomiserede, placebokontrollerede, fase III studier, som varede i 96 uger.
English: Uncommon (may affect less than 1 in 100 people)
Danish: Ikke almindelige (kan forekomme hos færre end 1 ud af 100 behandlede)
English: • Prevention of Skeletal Events in patients with breast cancer and bone metastases - added to 100 ml isotonic sodium chloride solution or 100 ml 5% dextrose solution and infused over at least 15 minutes.
Danish: • Forebyggelse af knoglerelaterede hændelser hos patienter med brystkræft og knoglemetastasertilsættes til 100 ml isotonisk natriumchlorid-infusionsvæske eller 100 ml 5 % glucoseinfusionsvæske og infunderes over mindst 15 minutter.
English: Table 1 Adverse Reactions Reported for Intravenous Administration of Ibandronic Acid
Danish: Tabel 1 Bivirkninger som er rapporteret efter intravenøst administreret ibandronsyre
English: - Patients should not chew, suck or crush the tablet because of a potential for oropharyngeal ulceration.
Danish: - Patienterne må ikke lægge sig ned før 60 minutter efter indtagelse af Iasibon - Patienterne må ikke tygge, sutte eller knuse tabletterne på grund af risiko for orofaryngeal ulceration.
English: There are no data on the effects of ibandronic acid in humans.
Danish: Der findes ingen humane data for effekten af ibandronsyre.
English: Iasibon contains less than 1 mmol sodium (23 mg) per vial, i.e. essentially sodium free.
Danish: Iasibon indeholder mindre end 1 mmol (23 mg) natrium pr. hætteglas, dvs. den er i det væsentlige natriumfri.
English: Uncommon Rare Very rare
Danish: Almindelig Ikke almindelig Sjælden
English: Osteonecrosis of the jaw has been reported in patients treated by bisphosphonates.
Danish: Knoglenekrose i kæben er rapporteret hos patienter, der behandles med bisphosphonater.
English: As no clinical data are available, dose recommendations cannot be given for patients with severe hepatic insufficiency(see section 4.2).
Danish: Da kliniske data ikke findes, kan dosis-rekommandation ikke gives for patienter med svær leverinsufficiens.
English: If you have a raised calcium level in your blood due to a tumour then the recommended dose is a single administration of 1 ampoule (2 mg) or 2 ampoules (4 mg), depending on the severity of your illness.
Danish: Hvis De har forhøjet indhold af kalk i blodet som følge af en svulst, er den anbefalede dosis 1 ampul (2 mg) én gang eller 2 ampuller (4 mg) én gang, afhængig af sværhedsgraden af Deres sygdom.
English: Talk to your doctor, pharmacist or nurse before receiving Iasibon:
Danish: Kontakt lægen, apotekspersonalet eller sundhedspersonalet, før du får Iasibon:
English: • pain in your nerves, damaged nerve root
Danish: • nervesmerter, nerverodslæsioner
English: Patients should receive supplemental calcium and/or vitamin D if dietary intake is inadequate.
Danish: Det er vigtigt, at alle patienter indtager tilstrækkeligt calcium og vitamin D. Hvis den daglige indtagelse gennem kosten ikke er tilstrækkelig, skal patienterne have tilskud af calcium og/eller vitamin D.
English: • It helps to prevent your bones from breaking (fractures).
Danish: Det hjælper med at forebygge knoglebrud.
English: What you need to know before you take Iasibon.
Danish: 2 Det skal de Vide, før de begynner at tage Iasibon
English: Iasibon 6mg is supplied as packs containing 1, 5 and 10 vials (9 ml type I glass vial with a bromobutyl rubber stopper).
Danish: Iasibon 6 mg findes i pakninger indeholdende 1, 5 og 10 hætteglas (9 ml type I hætteglas af type I glas med en brombutyl-gummiprop).
English: It is recommended that the product once diluted be used immediately (see point 5 of this leaflet ‘How to store Iasibon').
Danish: Det anbefales at opløsningen anvendes straks efter fortynding (se pkt.
English: Total clearance of ibandronic acid was reduced to 44 ml/min in the subjects with severe renal impairment compared with 129 mL/min in subjects with normal renal function.No dosage adjustment is necessary for patients with mild renal impairment (CLcr ≥50 and <80 mL/min).
Danish: Det samlede ibandronsyreclearance var reduceret til 44 ml/min hos patienter med svært nedsat nyrefunktion sammenlignet med 129 ml/min hos patienter med normal nyrefunktion.
English: If you are not sure, talk to your doctor or pharmacist before taking Iasibon.
Danish: Hvis De er i tvivl, så kontakt lægen eller apoteket, inden De tager Iasibon.
English: What Iasibon looks like and contents of the pack Iasibon is a colourless, clear solution.
Danish: Iasibon er en farveløs, klar opløsning.
English: The safety and efficacy of Iasibon in children and adolescents below the age of 18 years have not been established.
Danish: Sikkerheden og virkningen af Iasibon hos børn og unge under 18 år er ikke klarlagt.
English: Protein binding in human plasma is approximately 87% at therapeutic concentrations, and thusinteraction with other medicinal products, due to displacement is unlikely.
Danish: Proteinbindingen i humant plasma er ca. 87 % ved terapeutiske stofkoncentrationer.
English: • stomach problems such as ‘gastroenteritis' or ‘gastritis'
Danish: • maveproblemer, såsom mave-tarmkatar eller mavekatar
English: • if you have any swallowing or digestion problems
Danish: • hvis De har synkebesvær eller fordøjelsesbesvær.
English: Each film-coated tablet contains 50 mg of ibandronic acid (as sodium monohydrate)
Danish: Hver filmovertrukket tablet indeholder 50 mg ibandronsyre (som natriummonohydrat).
English: • The other ingredients are sodium chloride, glacial acetic acid, sodium acetate trihydrate and water for injections.
Danish: • Øvrige indholdsstoffer er: natriumchlorid, eddikesyre (99%), natriumacetattrihydrat og vand til injektionsvæsker.
English: Atypical subtrochant eric and diaphyseal femoral fractures†
Danish: Atypiske subtrochantær e og diafyseale femurfrakturer
English: • kidney cyst (fluid-filled sac in the kidney)
Danish: • cyste i nyre (væskefyldte blærer i nyre)
English: What you need to know before you receive Iasibon
Danish: 2 Det skal du vide, før du begynder at få Iasibon
English: NAME OF THE MEDICINAL PRODUCT Iasibon 50 mg film coated tablets
Danish: 1 LÆGEMIDLETS NAVN Iasibon 50 mg filmovertrukne tabletter
English: If you have a raised calcium level in your blood due to a tumour then the recommended dose is a single administration of 2 ampoules (2 mg) or 4 ampoules (4 mg), depending on the severity of your illness.
Danish: Hvis De har forhøjet indhold af kalk i blodet som følge af en svulst, er den anbefalede dosis 2 ampuller (2 mg) én gang eller 4 ampuller (4 mg) én gang, afhængig af sværhedsgraden af Deres sygdom.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Vial
Danish: MINDSTEKRAV TIL OPLYSNINGER, PÅ SMÅ INDRE EMBALLAGER HÆTTEGLAS
English: Rare (may affect up to 1 in 1,000 people)
Danish: Sjælden (kan forekomme hos 1 ud af 1000 behandlede)
English: Oesophagitis, abdominal pain, dyspepsia, nausea
Danish: Øsofagitis, abdominalsmerte r, dyspepsi, kvalme
English: % of Patients with Response
Danish: Ibandronsyre dosis % af patienter med respons
English: Blood alkaline phosphatase increase, weight decrease
Danish: Forhøjet basisk fosfatase i blodet, vægttab
English: NAME OF THE MEDICINAL PRODUCT Iasibon 50 mg film-coated tablets ibandronic acid
Danish: LÆGEMIDLETS NAVN Iasibon 50 mg filmovertrukne tabletter Ibandronsyre
English: Sodium acetate trihydrate
Danish: Natriumacetattrihydrat
English: Hypersensitivity bronchospasm†, angioedema†, Anaphylactic reaction/shock†
Danish: Overfølsomhed†, bronkospasme†, angioødem †, anafylaktisk reaktion/shock
English: Marketing Authorisation Holder Pharmathen S.A.
Danish: Indehaver af markedsføringstilladelsen Pharmathen S.A.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 50 mg of ibandronic acid (as sodium monohydrate).
Danish: 2 KVALITATIV OG KVANTITATIV SAMMENSÆTNING Hver filmovertrukket tablet indeholder 50 mg ibandronsyre (som natriummonohydrat).
English: Iasibon 1 mg is supplied as pack containing 1 ampoule (2 ml type I glass ampoule).
Danish: Iasibon 1 mg leveres i pakninger med 1 ampul (2 ml type I ampul).
English: INFORMATION IN BRAILLE Iasibon 50 mg
Danish: INFORMATION I BRAILLE-SKRIFT Iasibon 50 mg
English: • problems with your parathyroid gland
Danish: • problemer med biskjoldbruskkirtlen
English: If you are not sure, talk to your doctor or pharmacist before having Iasibon.
Danish: Hvis De er i tvivl, så kontakt lægen eller sundhedspersonalet, før du får Iasibon.
English: METHOD AND ROUTE(S) OF ADMINISTRATION
Danish: LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E)
English: Iasibon 2 mg is supplied as pack containing 1 ampoule (4 ml type I glass ampoule).
Danish: Iasibon 2 mg leveres i pakninger med 1 ampul (4 ml type I ampul).
English: - Water is the only drink that should be taken with Iasibon.
Danish: - Iasibon må kun indtages sammen med vand.
English: If you have severe kidney problems, your doctor may reduce your dose to one tablet each week.
Danish: Hvis De lider af nyreproblemer, kan Deres læge vælge at nedsætte dosis til én tablet hver anden dag (i tilfælde af moderat nyresygdom) eller til én tablet om ugen (i tilfælde af alvorlig nyresygdom).
English: Since Acetylsalicylic acid, Nonsteroidal Anti-Inflammatory medicinal products (NSAIDS) and bisphosphonates are associated with gastrointestinal irritation, caution should be taken during concomitant administration.
Danish: Acetylsalicylsyre og NSAID-præparater Da acetylsalicylsyre, NSAID-præparater og bisphosphonater er forbundet med gastrointestinal irritation, bør der udvises forsigtighed, hvis acetylsalicylsyre eller et NSAID-præparat administreres sammen med Iasibon.
English: • It is given as an infusion into your vein
Danish: det bliver givet som infusion i en blodåre.
English: In patients with moderate hypercalcaemia (albumincorrected serum calcium <3 mmol/l or <12 mg/dl) 2 mg is an effective dose.
Danish: Hos patienter med moderat hyperkalcæmi (albuminkorrigeret serum-calcium < 3 mmol/l eller < 12 mg/dl) er 2 mg en effektiv dosis.
English: • shaking or shivering
Danish: • rysten eller skælven
English: Iasibon should not be used during breast-feeding.
Danish: Iasibon bør ikke anvendes under amning.
English: Diarrhoea, vomiting, dyspepsia, gastrointestinal pain, tooth disorder
Danish: Diarré, opkastning, dyspepsi, gastrointestinale smerter, tandsygdomme
English: Since Acetylsalicylic acid, Nonsteroidal Anti-Inflammatory medicinal products (NSAIDs) and bisphosphonates are associated with gastrointestinal irritation, caution should be taken during concomitant administration (see section 4.4).
Danish: Acetylsalicylsyre og NSAID-præparater Da acetylsalicylsyre, NSAID-præparater og bisphosphonater er forbundet med gastrointestinal irritation, bør der udvises forsigtighed, hvis acetylsalicylsyre eller et NSAID-præparat administreres sammen med Iasibon (se pkt.
English: Patients with hepatic impairment
Danish: Patienter med nedsat hjertefunktion
English: Albumin-corrected serum calcium (mmol/l) = serum calcium (mmol/l) - [0.02 x albumin (g/l)] + 0.8 or Albumin-corrected serum calcium (mg/dl) =serum calcium (mg/dl) + 0.8 x [4 - albumin (g/dl)]
Danish: = Serum-calcium (mmol/l) - [0,02 x albumin (g/l)] + 0,8 Eller Albuminkorrigeret serum-calcium (mg/dl)
English: Osteonecrosis of jaw†**, osteonecrosis of the external auditory canal (bisphosphonate class adverse reaction)
Danish: Knoglenekrose i kæben†**, Osteonekrose af øregangen (klassebivirkning for bisfosfonater)
English: Cellulose, microcrystalline Crospovidone Maize starch pregelatinised Glycerol dibehenate Silica, anhydrous colloidal
Danish: Prægelatineret majsstivelse Glyceroldibehenat Silica, kolloid, vandfri
English: INFORMATION IN BRAILLE Iasibon 1 mg
Danish: INFORMATION I BRAILLE-SKRIFT Iasibon 1 mg
English: Paediatric population(see section 4.2 and section 5.2) The safety and efficacy of Iasibon in children and adolescents below the age of 18 years have not been established.
Danish: 4.2 og 5.2) Sikkerheden og virkningen af Iasibon hos børn og unge under 18 år er ikke klarlagt.
English: The safety and efficacy of Iasibonin children and adolescents below the age of 18 years have not been established.
Danish: Iasibons sikkerhed og virkning hos børn og unge under 18 år er ikke klarlagt.
English: If you have breast cancer that has spread to your bones, then the recommended dose is 3 ampoules (6 mg) every 3-4 weeks, as an infusion in your vein over at least 15 minutes.
Danish: Hvis De lider af brystkræft, som har spredt sig til Deres knogler, er den anbefalede dosis 3 ampuller (6 mg) hver 3.-4. uge, givet som infusion i en blodåre i løbet af mindst 15 minutter.
English: Manufacturer Pharmathen S.A. Dervenakion 6 Pallini 15351 Attiki
Danish: Fremstiller Pharmathen S.A. Dervenakion 6 Pallini 15351