FrancophonIA/ELRC3.0 huggingface dataset:
English: After swallowing your monthly Ibandronic Acid Teva tablet, wait for 1 hour before taking any other medication, including indigestion tablets, calcium supplements, or vitamins.
Danish: Efter indtagelse af din månedlige Ibandronsyre Teva-tablet, skal du vente 1 time, inden du tager anden medicin, herunder tabletter eller anden form for medicin mod dårlig fordøjelse, kalktilskud eller vitaminer.
English: - If you have certain problems with your gullet/food pipe (oesophagus) such as narrowing or difficulty swallowing.
Danish: • hvis du har visse problemer med spiserøret/mavesækken, såsom indsnævring eller synkebesvær
English: The recommended dose is one 150 mg film-coated tablet once a month.
Danish: Den anbefalede dosis er én 150 mg filmovertrukket tablet én gang om måneden.
English: Influenza like illness*
Danish: Influenzalignende sygdom*
English: • pain or sore in your mouth or jaw.
Danish: • smerte eller ømhed i munden eller kæben.
English: • Take your tablet as soon as you get up for the day before having your first food, drink, any medicine or supplements.
Danish: • Tag din tablet så snart du står op om morgenen, før du spiser noget, drikker noget eller tager nogen form for medicin, vitaminer og mineraler eller kosttilskud.
English: • tablet core: cellulose microcrystalline, povidone K-30, crospovidone (type A), silica colloidal anhydrous, stearic acid;
Danish: • tabletkerne: mikrokrystallinsk cellulose, povidon K-30, crospovidon (type A), kolloid vandfri silica, stearinsyre.
English: Ibandronic Acid Teva tablets should be taken after an overnight fast (at least 6 hours) and before the first food or drink of the day.
Danish: Ibandronsyre Teva-tabletter skal indtages efter faste om natten (mindst 6 timer) og før indtagelse af dagens første mad- og drikkevarer.
English: Milk or antacids should be given to bind Ibandronic Acid Teva, and any adverse reactions treated symptomatically.
Danish: Der bør indtages mælk eller antacida med henblik på at binde Ibandronsyre Teva, og bivirkninger behandles symptomatisk.
English: In healthy male volunteers and postmenopausal women, intravenous administration of ranitidine caused an increase in ibandronic acid bioavailability of about 20%, probably as a result of reduced gastric acidity.
Danish: Hos raske mandlige forsøgspersoner og hos postmenopausale kvinder medførte intravenøs administration af ranitidin en ca. 20 % øgning i biotilgængeligheden af ibandronsyre, formentlig som et resultat af den reducerede gastriske surhedsgrad.
English: Reporting suspected adverse reactions after authorisation of the medicinal product is important.
Danish: Når lægemidlet er godkendt, er indberetning af mistænkte bivirkninger vigtig.
English: Analgesic use *
Danish: Analgetikaforbrug *
English: Protein binding in human plasma is approximately 85 %-87 % (determined in vitro at therapeutic concentrations), and thus there is a low potential for interaction with other medicinal products due to displacement.
Danish: Proteinbindingen i humant plasma er ca. 85 %-87 % (bestemt in vitro ved terapeutiske koncentrationer).
English: Month 3 __/__/__
Danish: Måned 3 __/__/__
English: - Supplements containing calcium, magnesium, iron or aluminium, as they could possibly influence the effects of Ibandronic Acid Teva.
Danish: • Kosttilskud, som indeholder kalk, magnesium, jern eller aluminium, idet de muligvis kan påvirke virkningen af Ibandronsyre Teva
English: Children and adolescents Do not give Ibandronic Acid Teva to children or adolescents below 18 years.
Danish: Børn og unge Giv ikke Ibandronsyre Teva til børn og teenagere under 18 år.
English: For patients with severe renal impairment (CLcr <30 mL/min) the recommended dose is one 50 mg film-coated tablet once weekly.
Danish: For patienter med svært nedsat nyrefunktion (kreatininclearance < 30 ml/min) er den anbefalede dosis én 50 mg filmovertrukket tablet én gang ugentligt.
English: - If you have any swallowing or digestive problems.
Danish: • hvis du har problemer med at synke eller har fordøjelsesproblemer
English: • tablet coating: titanium dioxide (E 171), hypromellose, macrogol 400, polysorbate 80.
Danish: • tabletovertræk: titandioxid (E171), hypromellose, macrogol 400, polysorbat 80.
English: - radiotherapy to bone for treatment of fractures/impending fractures, - surgery to bone for treatment of fractures, - vertebral fractures, - non-vertebral fractures.
Danish: - knoglekirurgi for behandling af frakturer - vertebrale frakturer - non-vertebrale frakturer.
English: The pharmacokinetics of ibandronic acid was not assessed in patients with end-stage renal disease managed by other than hemodialysis.
Danish: Farmakokinetikken for ibandronsyre blev ikke undersøgt hos patienter med terminal nyresygdom behandlet med andet end hæmodialyse.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/10/642/001 28 film-coated tablets
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) EU/1/10/642/001 28 filmovertrukne tabletter
English: Therefore, patients should fast overnight (at least 6 hours) before taking Ibandronic Acid Teva and continue fasting for 1 hour following intake of Ibandronic Acid Teva (see section 4.2).
Danish: Patienterne skal derfor faste natten over (mindst 6 timer) inden indtagelse af Ibandronsyre Teva og fortsætte med at faste 1 time efter indtagelsen af Ibandronsyre Teva (se pkt.
English: If you develop these symptoms, stop taking Ibandronic Acid Teva and tell your doctor straight away (see section 3).
Danish: Hvis du får disse symptomer, skal du straks stoppe med at tage Ibandronsyre Teva og kontakte lægen (se punkt 3).
English: UNIQUE IDENTIFIER - 2D BARCODE 2D barcode carrying the unique identifier included.
Danish: Der er anført en 2D-stregkode, som indeholder en entydig identifikator.
English: Do not chew, suck or crush the tablet.
Danish: Lad være med at tygge, sutte, eller knuse tabletten.
English: Do not use this medicine after the expiry date which is stated on the blister and carton after EXP.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på blisteren og pakningen efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
English: Anaphylactic reaction/shock*
Danish: Anafylaktisk reaktion/shock*†
English: The usual dose of Ibandronic Acid Teva is one tablet once a month.
Danish: Den sædvanlige dosis Ibandronsyre Teva er 1 tablet én gang om måneden.
English: Month 2 __/__/__
Danish: Måned 2 __/__/__
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/mavesækken.
English: Ibandronic Acid Teva 150 mg: Medicinal product subject to medical prescription.
Danish: Ibandronsyre Teva 150 mg: Lægemidlet er receptpligtigt.
English: Ibandronic Acid Teva is only for use in postmenopausal women and must not be taken by women of childbearing potential.
Danish: Ibandronsyre Teva er kun til brug hos postmenopausale kvinder og må ikke anvendes af fertile kvinder.
English: - Take your Ibandronic Acid Teva tablet at least 6 hours after you last had anything to eat or drink except water.
Danish: • Indtag Ibandronsyre Teva-tabletten mindst 6 timer efter, at du sidst har spist eller drukket, bortset fra vand.
English: Patients should then return to taking their dose once a month on their originally scheduled date.
Danish: Derefter skal de igen tage en tablet én gang om måneden som oprindeligt planlagt.
English: Studies in rats have shown some reproductive toxicity (see section 5.3).
Danish: Studier med rotter har vist en vis reproduktionstoksisitet (se pkt.
English: - Patients should not lie down for 60 minutes after taking Ibandronic Acid Teva.
Danish: - Patienterne må ikke lægge sig ned før 60 minutter efter indtagelse af Ibandronsyre Teva.
English: In a two-year study in postmenopausal women with osteoporosis (BM 16549) the overall safety of ibandronic acid 150 mg once monthly and ibandronic acid 2.5 mg daily was similar.
Danish: I et toårs studie hos postmenopausale kvinder med osteoporose (BM 16549) var sikkerheden af ibandronsyre 150 mg én gang om måneden den samme som for ibandronsyre 2,5 mg daglig.
English: Ibandronic acid leads to progressive net gains in bone mass and a decreased incidence of fractures through the reduction of elevated bone turnover towards premenopausal levels in postmenopausal women.
Danish: Ibandronsyre medfører hos postmenopausale kvinder en tiltagende forøgelse af knoglemassen og en nedsat frakturhyppighed ved en reduktion af den øgede knogleomsætning hen imod et præmenopausalt niveau.
English: You may have a severe inflammation of your gullet/food pipe, possibly with sores or constriction of the gullet/food pipe
Danish: Du kan have en alvorlig betændelse i spiserøret, muligvis med sår, eller forsnævringer i spiserøret
English: Ibandronic Acid Teva belongs to a group of medicines called bisphosphonates.
Danish: Ibandronsyre Teva tilhører en medicingruppe, som kaldes bisphosphonater.
English: - Take one Ibandronic Acid Teva 150 mg tablet once a month.
Danish: • Tag én Ibandronsyre Teva 150 mg tablet én gang om måneden.
English: Posology The recommended dose is one 50 mg film-coated tablet daily.
Danish: Dosering Den anbefalede dosis er én 50 mg filmovertrukket tablet dagligt.
English: Azotaemia (uraemia)
Danish: Azotæmi (uræmi)
English: Adequate intake of calcium and vitamin D is important in all patients.
Danish: Det er vigtigt at alle patienter indtager tilstrækkeligt calcium og vitamin D.
English: If you are under dental treatment or will undergo dental surgery (e.g. tooth extractions), inform your doctor about your dental treatment and tell your dentist that you are being treated with Ibandronic Acid Teva.
Danish: Informer din læge, hvis du er i gang med en tandbehandling eller vil få foretaget en tandoperation (f.eks. tandudtrækning), og fortæl ligeledes din tandlæge, at du er i behandling med Ibandronsyre Teva.
English: Existing hypocalcaemia must be corrected before starting Ibandronic Acid Teva therapy.
Danish: Eksisterende hypokalcæmi skal behandles, før behandling med Ibandronsyre Teva initieres.
English: Bone resorption due to malignant disease is characterized 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: Patients with renal impairment Exposure to ibandronic acid in patients with various degree of renal impairment is related to creatinine clearance (CLcr).
Danish: Eksponering af ibandronsyre hos patienter med forskellige grader af nedsat nyrefunktion er relateret til kreatininclearance (CLcr ).
English: Ibandronic acid 50 mg n=287
Danish: Ibandronsyre 50 mg n=287
English: For patients with moderate renal impairment (CLcr ≥30 and <50 mL/min) or severe renal impairment (CLcr <30 mL/min) an adjustment in the dose is recommended (see section 4.2).
Danish: Hos patienter med moderat nedsat nyrefunktion (CLcr ≥ 30 og < 50 ml/min) eller svært nedsat nyrefunktion (CLcr < 30 ml/min) anbefales dosisjustering (se pkt.
English: The pharmacodynamic action of ibandronic acid is inhibition of bone resorption.
Danish: Den farmakodynamiske virkning af ibandronsyre er hæmning af knogleresorptionen.
English: Children and adolescents Ibandronic Acid Teva should not be used in children and adolescents below the age of 18 years.
Danish: Børn og teenagere Ibandronsyre Teva må ikke anvendes til børn og teenagere under 18 år.
English: If there is a concern regarding potentially high levels of calcium in the tap water (hard water), it is advised to use bottled water with a low mineral content.
Danish: Hvis der er usikkerhed omkring et eventuelt for højt kalkindhold i postevandet, anbefales det at bruge vand på flaske med et lavt mineralindhold.
English: Blood parathyroid hormone increased
Danish: Forhøjet parathyroideahor mon i blodet
English: Do not take Ibandronic Acid Teva if you are pregnant or breast feeding.
Danish: Tag ikke Ibandronsyre Teva, hvis du er gravid eller ammer.
English: EU/1/10/642/003 1 film-coated tablet in PVC/Aclar/PVC - Aluminium blister in cardboard boxes EU/1/10/642/004 3 film-coated tablets in PVC/Aclar/PVC - Aluminium blisters in cardboard boxes
Danish: EU/1/10/642/003 1 filmovertrukne tabletter i PVC/Aclar/PVC - Aluminiumsblistre kartonæsker EU/1/10/642/004 3 filmovertrukne tabletter i PVC/Aclar/PVC - Aluminiumsblistre i kartonæsker
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 ved ibandronsyre hos rotter i reproduktions-toksicitets-undersøgelserne var de samme som for denne gruppe lægemidler (bisphosphonater).
English: This is because Ibandronic Acid Teva can affect the way some other medicines work.
Danish: Dette skyldes, at Ibandronsyre Teva kan påvirke den måde anden medicin virker på, ligesom anden medicin kan påvirke den måde, hvorpå Ibandronsyre Teva virker.
English: If you forget to take Ibandronic Acid Teva - If you forget to take your tablet on the morning of your chosen day, do not take a tablet later in the day.
Danish: • Hvis du glemmer at tage din tablet om morgenen på den valgte dag, må du ikke tage tabletten senere på dagen.
English: Cases of osteonecrosis of the jaw have been reported, predominantly in cancer patients treated with medicinal products that inhibit bone resorption, such as ibandronic acid (see section 4.4.)
Danish: Tilfælde af knoglenekrose i kæben er blevet rapporteret, overvejende hos kræftpatienter i behandling med lægemidler, der hæmmer knogleresorption, såsom ibandronsyre (se pkt.
English: Biotransformation There is no evidence that ibandronic acid is metabolised in animals or humans.
Danish: Der er ikke tegn på, at ibandronsyre metaboliseres i dyr eller mennesker.
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 rapporterede bivirkninger er anafylaktisk reaktion/shock, atypiske femurfrakturer, knoglenekrose i kæben, gastrointestinal irritation og inflammation i øjet (se afsnit ”Beskrivelse af udvalgte bivirkninger” og pkt.
English: EU/1/10/642/001 28 film-coated tablets in PVC/Aclar/PVC - Aluminium blisters in cardboard boxes EU/1/10/642/002 84 film-coated tablets in PVC/Aclar/PVC - Aluminium blisters in cardboard boxes
Danish: EU/1/10/642/001 28 filmovertrukne tabletter i PVC/Aclar/PVC - Aluminiumblistre i kartonæsker EU/1/10/642/002 84 filmovertrukne tabletter i PVC/Aclar/PVC Aluminiumsblistre i kartonæsker
English: Oesophagitis including oesophageal ulcerations or strictures and dysphagia, Vomiting, Flatulence
Danish: Øsofagitis inklusive øsofageale ulcerationer eller strikturer og dysfagi, opkastning, flatulens
English: Due to limited clinical experience, Ibandronic Acid Teva is not recommended for patients with a creatinine clearance below 30 ml/min (see section 5.2).
Danish: På grund af begrænset klinisk erfaring kan Ibandronsyre Teva ikke anbefales til patienter med kreatinin-clearance lavere end 30 ml/min (se pkt.
English: Temporary interruption of Ibandronic Acid Teva treatment should be considered until the condition resolves and contributing risk factors are mitigated where possible.
Danish: Hvis det er muligt, bør det overvejes at seponere behandlingen med Ibandronsyre Teva midlertidigt, indtil tilstanden forbedres og risikofaktorerne for knoglenekrose i kæben er reduceret.
English: For these patients, there was no difference in the incidence of upper gastrointestinal adverse events with the 150 mg once monthly regimen compared to the 2.5 mg daily regimen.
Danish: For disse patienter var der ingen forskel i incidensen af øvre gastrointestinale bivirkninger, uanset om de fik 150 mg én gang om måneden eller 2,5 mg daglig.
English: Bone mineral density (BMD)
Danish: Knoglemineraltæthed (BMD)
English: The most serious reported adverse reactions are anaphylactic reaction/shock, atypical fractures of the femur, osteonecrosis of the jaw, gastrointestinal irritation, ocular inflammation, (see paragraph “Description of selected adverse reactions” and section 4.4).
Danish: De mest alvorlige indberettede bivirkninger er anafylaktisk reaktion/shock, atypiske femurfrakturer, knoglenekrose i kæben, gastrointestinal irritation, inflammation i øjet, (se afsnittet ”Beskrivelse af udvalgte bivirkninger ” og pkt.
English: There is no meaningful reduction in bioavailability provided ibandronic acid is taken 60 minutes before the first food of the day.
Danish: Der er ingen relevant nedsættelse af biotilgængeligheden, når ibandronsyre indtages 60 minutter før dagens første måltid.
English: In vivo, ibandronic acid prevents experimentally-induced bone destruction caused by cessation of gonadal function, retinoids, tumours or tumour extracts.
Danish: In vivo forhindrer ibandronsyre eksperimentelt-induceret knogleødelæggelse forårsaget af ophøret af den gonadale funktion, retinoider, tumorer eller tumorekstrakter.
English: The liver has no significant role in the clearance of ibandronic acid since it is not metabolized but is cleared by renal excretion and by uptake into bone.
Danish: Leveren spiller ikke nogen væsentlig rolle ved udskillelsen af ibandronsyre, da det ikke metaboliseres, men udskilles gennem nyrerne, samt ved optagelse i knoglerne.
English: Ocular inflammation
Danish: Inflammation i øjet
English: Do not use this medicine after the expiry date which is stated on the blister and carton after “EXP”.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på blisteren og pakningen efter EXP. Udløbsdatoen (Exp) er den sidste dag i den nævnte måned.
English: At two years, 87.1 % (p<0.001) and 70.5 %,of patients met this criterion in the 150 mg monthly and 2.5 mg daily arms respectively.
Danish: Efter to år mødte 87,1 % (p<0,001) og 70,5 % af patienterne dette kriterium i armene for henholdsvis 150 mg én gang om måneden og 2,5 mg daglig.
English: Other medicines and Ibandronic Acid Teva Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Danish: Brug af anden medicin sammen med Ibandronsyre Teva Fortæl altid til lægen eller apotekspersonalet, hvis du tager anden medicin eller har gjort det for nylig.
English: • flu-like symptoms, feeling generally unwell or in pain
Danish: • influenzalignende symptomer, følelse af utilpashed eller smerte
English: The liver has no significant role in the clearance of ibandronic acid which is not metabolised but is cleared by renal excretion and by uptake into bone.
Danish: Leveren spiller ikke nogen væsentlig rolle ved udskillelsen af ibandronsyre, som ikke metaboliseres, men udskilles via nyrerne samt optages i knoglerne.
English: In reproductive studies in rats by the oral route, ibandronic acid decreased fertility.
Danish: I reproduktionsstudier på rotter nedsatte ibandronsyre fertiliteten efter oral indgift.
English: Studies in rats have shown reproductive toxicity (see section 5.3).
Danish: Studier med rotter har påvist reproduktionstoksisitet (se pkt.
English: Hypersensitivi ty†, bronchospasm angioedema†, anaphylactic reaction/shock
Danish: Overfølsomh ed†, bronkospasm e†, angioødem †, anafylaktisk reaktion/shoc k
English: Patients should receive supplemental calcium and / or vitamin D if dietary intake is inadequate (see sections 4.4 and 4.5).
Danish: Patienten bør have et calcium- og/eller D-vitamintilskud, hvis der ikke indtages nok gennem kosten (se pkt.
English: Table 3: Results from 3 years fracture study MF 4411 (%, 95 % CI)
Danish: Tabel 3: Resultater fra 3-års frakturstudiet MF 4411 (%, 95 % Konfidensinterval) Placebo (N=974)
English: Your doctor may ask you to undergo a dental examination before starting treatment with Ibandronic Acid Teva.
Danish: Din læge kan bede dig om at gennemgå et tandeftersyn før behandling med Ibandronsyre Teva.
English: It is not known whether ibandronic acid is excreted in human milk.
Danish: Det vides ikke om ibandronsyre udskilles i modermælk.
English: The unabsorbed fraction of ibandronic acid is eliminated unchanged in the faeces.
Danish: Den ikke-absorberede del af ibandronsyre udskilles i uændret form via fæces.
English: However, oral overdosage may result in upper gastrointestinal events, such as upset stomach, heartburn, oesophagitis, gastritis or ulcer.
Danish: Overdosering kan dog forårsage øvre gastrointestinale bivirkninger som f.eks. mavebesvær, halsbrand, øsofagitis, gastritis eller mavesår.
English: • severe stomach pain.
Danish: • stærke mavesmerter.
English: Primary efficacy endpoints
Danish: Primære effektparametre
English: Chest pain, influenza-like illness, malaise, pain
Danish: Brystsmerter, influenzalignende sygdom, utilpashed, smerter
English: Metabolic interactions are not considered likely, since ibandronic acid does not inhibit the major human hepatic P450 isoenzymes and has been shown not to induce the hepatic cytochrome P450 system in rats (see section 5.2).
Danish: Metaboliske interaktioner anses ikke for sandsynlige, da ibandronsyre ikke hæmmer de primære humane CYP-isoenzymer og er vist ikke at inducere CYP-systemet hos rotter (se pkt.
English: After one year (primary analysis) the median relative change from baseline was -76 % for ibandronic acid 150 mg once monthly and -67 % for ibandronic acid 2.5 mg daily.
Danish: Efter et år (primær analyse) var de mediane, relative ændringer fra baseline -76 % for gruppen, som fik ibandronsyre 150 mg én gang om måneden og -67 % for gruppen, som fik ibandronsyre 2,5 mg daglig.
English: Film-coated tablet.
Danish: Filmovertrukket tablet
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 17 September 2010
Danish: DATO FOR FØRSTE MARKEDSFØRINGSTILLADELSE/FORNYELSE AF TILLADELSEN
English: There is no meaningful reduction in bioavailability provided ibandronic acid is taken 60 minutes before a meal.
Danish: Der er ingen relevant nedsættelse af biotilgængeligheden, når ibandronsyre indtages 60 minutter før et måltid.
English: Elderly population (see section 4.2)
Danish: Pædiatrisk population (se pkt 4.2 og pkt.
English: In addition, ibandronic acid does not inhibit the major human hepatic P450 isoenzymes and does not induce the hepatic cytochrome P450 system in rats.
Danish: Derudover hæmmer ibandronsyre ikke de vigtigste humane CYP-isoenzymer og inducerer ikke CYP-systemet hos rotter.
English: Osteonecrosis of the external auditory canal has been reported with bisphosphonates, mainly in association with long-term therapy.
Danish: Knoglenekrose i den ydre øregang er blevet rapporteret ved behandling med bisphosphonat, primært i forbindelse med en langtidsbehandling.
English: Relative Risk Reduction New morphometric vertebral fractures
Danish: Relativ Risiko Reduktion Nye morfometriske vertebrale frakturer
English: There is no evidence for any clinically relevant inter-ethnic differences between Asians and Caucasians in ibandronic acid disposition.
Danish: Der er ikke noget, der tyder på en klinisk relevant inter-etnisk forskel i tilstedeværelsen af ibandronsyre mellem asiater og kaukasere.
English: This reduction in fractures was shown for the spine but not for the hip.
Danish: Reduktionen i knoglebrud er vist for brud i rygsøjlen, men ikke for hoftebrud.
English: Among these patients, the incidence of upper gastrointestinal events in the patients treated with ibandronic acid 150 mg once monthly was similar to that in patients treated with ibandronic acid 2.5 mg daily.
Danish: Incidensen af øvre gastrointestinale hændelser var den samme hos patienter, som blev behandlet med 150 mg ibandronsyre én gang om måneden, som hos patienter, som blev behandlet med 2,5 mg ibandronsyre daglig.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE