FrancophonIA/ELRC3.0 huggingface dataset:
English: Wilate 1000 Octapharma Gmbh Human Coagulation Factor VIII, Human Von
Danish: Wilate 1000 Octapharma Gmbh Human koagulationsfaktor VIII,
English: Human Coagulation Factor VIII (Rdna) 200 I.U.
Danish: Human koagulationsfaktor VIII (rDNA) 200 IE /ml
English: Luxembourg Haemate P Csl Behring Gmbh Human Coagulation Factor VIII, Human Von
Danish: Luxembourg Haemate P Csl Behring Gmbh Human koagulationsfaktor VIII,
English: Human Coagulation Factor VIII 500 I.U.
Danish: Human koagulationsfaktor VIII 500 IE.
English: Human Coagulation Factor VIII (Rdna) 500IU/Vial
Danish: Human koagulationsfaktor VIII (rDNA) 500 IE /5 ml
English: Octapharma Ab Human Coagulation Factor VIII, Human Von Willebrand Factor
Danish: Octapharma Ab Human koagulationsfaktor VIII, Human Von
English: Human Coagulation Factor VIII 1500 I.E.
Danish: Human koagulationsfaktor VIII 1.500 IE
English: Human Coagulation Factor VIII (Rdna) 100 I.U.
Danish: Human koagulationsfaktor VIII (rDNA) 100 IE /ml
English: Octapharma-Ltd Human Coagulation Factor VIII, Human Von Willebrand Factor
Danish: Octapharma-Ltd Human koagulationsfaktor VIII, Human Von
English: Human Coagulation Factor VIII 2000 IU
Danish: Human koagulationsfaktor VIII 2.000 IE
English: United Kingdom Haemate P Csl Behring Gmbh Human Coagulation Factor VIII, Human Von
Danish: Storbritannien Haemate P Csl Behring Gmbh Human koagulationsfaktor VIII,
English: Human Coagulation Factor VIII (Rdna) 25 I.U.
Danish: Human koagulationsfaktor VIII (rDNA) 25 IE /ml
English: Human Coagulation Factor VIII 100 I.U./ml, Human Von Willebrand Factor 100 I.U./mlVIII
Danish: Human koagulationsfaktor VIII 100 IE /ml, Von Willebrand-faktor 25 IE /ml
English: Belgium Recombinate Baxalta Innovations Gmbh
Danish: Grækenland Recombinate Baxalta Innovations GmbH
English: Human Coagulation Factor VIII 500IU/Vial
Danish: Human koagulationsfaktor VIII 500 IE/hætteglas, Human Von
English: Human Coagulation Factor VIII (Rdna) 50 I.U.
Danish: Human koagulationsfaktor VIII (rDNA) 50 IE /ml
English: Human Coagulation Factor VIII 1000IU/Vial
Danish: Human koagulationsfaktor VIII 1.000 IE /10 ml Human Von
English: / ml, Von Willebrand Factor 25 I.U.
Danish: Willebrand-faktor 75 IE /ml
English: Human Coagulation Factor VIII (Rdna) 250IU/Vial
Danish: Human koagulationsfaktor VIII (rDNA) 250 IE /5 ml
English: Haemate P Csl Behring Gmbh Human Coagulation Factor VIII, Human Von
Danish: Haemate P Csl Behring Gmbh Human koagulationsfaktor VIII (rDNA), Human Von
English: Human Coagulation Factor VIII 250IU/Vial
Danish: Human koagulationsfaktor VIII 250 IE /2,5 ml Human Von
English: Haemate P CSL Behring Gmbh Human Coagulation Factor VIII Human Von
Danish: Haemate P CSL Behring Gmbh Human koagulationsfaktor VIII,
English: Human Coagulation Factor VIII (Rdna) 500 I.U.
Danish: Human koagulationsfaktor VIII (rDNA) 500 IE Hætteglas
English: Octapharma Gmbh Human Coagulation Factor VIII, Human Von Willebrand Factor
Danish: Octapharma Gmbh Human koagulationsfaktor VIII, Human Von
English: Haemate P Csl Behring Mepe Human Coagulation Factor VIII, Human Von
Danish: Grækenland Haemate P Csl Behring Mepe Human koagulationsfaktor VIII,
English: / 5 ml
Danish: 500 IE/hætteglas
English: Human Coagulation Factor VIII (Rdna) 1000 I.U.
Danish: Human koagulationsfaktor VIII (rDNA) 1.000 IE Hætteglas
English: Human Coagulation Factor VIII (Rdna) 250 I.U.
Danish: Human koagulationsfaktor VIII (rDNA) 250 IE Hætteglas
English: Date of first authorisation: 24 June 2016
Danish: Dato for første markedsføringstilladelse: 24. juni 2016
English: There is no known specific antidote.
Danish: Der er ingen kendt specifik antidot.
English: HDPE bottles: 3 years Blisters: 5 years
Danish: HDPE-flasker: 3 år Blistre: 5 år
English: The magnitude of this effect is not considered to be of clinical relevance.
Danish: Størrelsen af denne effekt betragtes ikke som klinisk relevant.
English: The capsules are packaged in bottles or blisters.
Danish: Kapslerne er pakket i flasker eller blistre.
English: Children and adolescents under the age of 18 years must not take this medicine as it has not been studied in these age groups.
Danish: Børn og unge under 18 år må ikke tage dette lægemiddel, da det ikke er blevet undersøgt hos denne aldersgruppe.
English: Overall, it can be concluded that the kidney is not the primary route of excretion.
Danish: Det kan generelt konkluderes, at nyrerne ikke er den primære udskillelsesvej.
English: Caution must be exercised in patients ≥ 85 years of age as there is limited experience in this age group.
Danish: Der skal udvises forsigtighed hos patienter ≥ 85 år, da der er begrænset erfaring med denne aldersgruppe.
English: This will help the doctor identify what you have taken.
Danish: Det vil gøre det nemmere for lægen at finde ud af, hvad du har taget.
English: Dyskinesia was the most frequently reported treatment-emergent adverse reaction (17.7%).
Danish: Dyskinesier var den hyppigst rapporterede behandlingsrelaterede bivirkning (17,7 %).
English: Although embryo-foetal development was not negatively influenced in rabbits, the study is not considered predictive for human risk assessment.
Danish: Selvom den embryo-føtale udvikling ikke var negativt påvirket hos kaniner, betragtes studiet ikke som prædiktivt for human risikovurdering.
English: Medicinal products metabolised by COMT
Danish: Lægemidler, der metaboliseres af COMT
English: Note: A responder was a patient who had a reduction of at least 1 hour in absolute OFF-time (OFF-time responder)
Danish: Bemærk: En respondent var en patient, som havde en reduktion i samlet OFF-tid på mindst 1 time (OFFtidsrespondent)
English: The capsules should be swallowed whole with water.
Danish: Kapslerne skal sluges hele med vand.
English: Symptomatic and supportive treatment should be administered as appropriate.
Danish: Der skal administreres relevant symptomatisk og understøttende behandling.
English: Elderly (≥ 65 years old)
Danish: Ældre (≤ 65 år)
English: The recommended dose is 50 mg once daily.
Danish: Den anbefalede dosis er 50 mg én gang dagligt.
English: Tell your doctor as soon as possible if you notice any of the following side effects:
Danish: Du skal så hurtigt som muligt fortælle din læge, hvis du bliver opmærksom på nogle af følgende bivirkninger:
English: There are no or limited amount of data from the use of opicapone in pregnant women.
Danish: Der er ingen eller utilstrækkelige data fra anvendelse af opicapon til gravide kvinder.
English: At screening, the mean age was similar in all treatment groups in both studies, ranging between 61.5 and 65.3 years.
Danish: Ved screening var gennemsnitsalderen ens i alle behandlingsgrupper i de to studier og lå i intervallet 61,5 og 65,3 år.
English: Take Ongentys at least one hour before or after taking your levodopa medicine.
Danish: Tag Ongentys mindst én time før eller efter, du tager din levodopa-medicin.
English: Very common: may affect more than 1 in 10 people - involuntary and uncontrollable, or difficult or painful body movements
Danish: Meget almindelig: kan forekomme hos flere end 1 ud af 10 patienter - ufrivillige og ukontrollerbare bevægelser eller svært ved at bevæge kroppen eller smertefulde bevægelser
English: All reductions in activity essentially occurred at the highest concentration of opicapone (10 mcg/mL).
Danish: Alle reduktioner i aktivitet forekom i det væsentlige ved den højeste koncentration af opicapon (10 mikrog/ml).
English: Side effects caused by Ongentys are usually mild to moderate and occur mostly within the first weeks of treatment.
Danish: Bivirkninger forårsaget af Ongentys er ofte lette til moderate og opstår for det meste inden for de første uger af behandlingen.
English: Although there is no evidence that either the efficacy or safety of opicapone would be affected by use of controlled-release levodopa preparations, the experience with such preparations is limited.
Danish: Selvom der ikke er evidens for, at hverken opicapons virkning eller sikkerhed påvirkes af levodopapræparater med kontrolleret frigivelse, er erfaringen med sådanne præparater begrænset.
English: Frequency categories are defined as follows: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000), not known (cannot be estimated from the available data).
Danish: Hyppigheden er defineret på følgende måde: meget almindelig (≥ 1/10), almindelig (≤ 1/100 til < 1/10), ikke almindelig (≤ 1/1.000 til < 1/100), sjælden (≤ 1/10.000 til < 1/1.000), meget sjælden (< 1/10.000), ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: Do not stop taking Ongentys unless your doctor tells you to as your symptoms may get worse.
Danish: Du må ikke stoppe med at tage Ongentys, medmindre du har fået besked på det af lægen, da dine symptomer kan blive værre.
English: Contact your doctor straight away if you experience any side effects at the start of treatment.
Danish: Kontakt straks din læge, hvis du får bivirkninger i starten af behandlingen.
English: Other metabolic pathways include glucuronidation, methylation and reduction.
Danish: Andre metaboliseringsveje inkluderer glukuronidering, metylering og reduktion.
English: Swallow the capsule whole with a glass of water.
Danish: Synk kapslen hel med et glas vand til.
English: Table 2 - Change in absolute OFF-time and ON-time (minutes) from baseline to endpoint Treatment
Danish: Tabel 2 - Ændring i samlet OFF-tid og ON-tid (minutter) fra baseline til endepunkt Behandling
English: Hence, the precautions valid for levodopa treatment should also be taken into account for Ongentys.
Danish: Derfor skal de forsigtighedsregler, der gælder for levodopa, ligeledes tages i betragtning for Ongentys.
English: Therefore, caution should be exercised when driving or using machines.
Danish: Der bør derfor udvises forsigtighed, når der føres motorkøretøj eller betjenes maskiner.
English: Change in total ON-time without troublesome dyskinesiasa
Danish: Ændring i samlet ON-tid uden generende dyskinesiera
English: Dysgeusia, Hyperkinesia, Syncope
Danish: Dysgeusi, hyperkinesi, synkope
English: The remainder of the radioactivity was excreted in urine (mean 12.8%) and via expired air (mean 15.9%).
Danish: Den resterende radioaktivitet blev udskilt i urin (gennemsnit 12,8 %) og via udåndingsluften (gennemsnit 15,9 %).
English: Hence, it is often necessary to adjust levodopa dosage within the first days to first weeks after initiating the treatment with opicapone (see section 4.4).
Danish: Det er derfor ofte nødvendigt at justere levodopadosis inden for de første dage til uger efter påbegyndelse af opicapon-behandling (se pkt.
English: Do not drive or operate machinery if you experience any of these side effects.
Danish: Du må ikke køre motorkøretøj eller betjene maskiner, hvis du får disse bivirkninger.
English: Taking Ongentys and quinidine together, i.e. at the same time, may decrease the effect of Ongentys.
Danish: Hvis du tager Ongentys og kinidin sammen, det vil sige på samme tidspunkt, kan det nedsætte virkningen af Ongentys.
English: Difference to placebo p-value (95% CI)
Danish: Forskel i forhold til placebo p-værdi (95 % CI)
English: In the OL studies, all patients began at a dose of 25 mg opicapone for the first week (7 days), regardless of their prior treatment in the double-blind period.
Danish: I OL-studierne startede alle patienter med en dosis på 25 mg opicapon i den første uge (7 dage) uanset deres tidligere behandling i den dobbeltblinde periode.
English: BIA 9-1103 plasma levels were not affected in patients with chronic renal impairment, and as such, no dose adjustment needs to be considered.
Danish: BIA 9-1103-plasmaniveauet var ikke påvirket hos patienter med kronisk nyreinsufficiens, og det er derfor ikke nødvendigt at overveje dosisjustering.
English: Parkinson's disease is a progressive disease of the nervous system that causes shaking and affects your movement.
Danish: Parkinsons sygdom er en fremadskridende lidelse i nervesystemet, som medfører rysten og påvirker dine bevægelser.
English: Follow the instructions that your doctor has given you.
Danish: Følg lægens anvisninger.
English: If end-of-dose motor fluctuations were not sufficiently controlled and tolerability allowed, the opicapone dose could be increased to 50 mg.
Danish: Hvis motoriske end-of-dose fluktuationer ikke var tilstrækkeligt kontrollerede, og tolerabiliteten tillod det, kunne opicapondosis øges til 50 mg.
English: In Study 1, 122 patients were treated with opicapone 5 mg and 122 patients were treated with entacapone 200 mg (active comparator).
Danish: I studie 1 blev 122 patienter behandlet med opicapon 5 mg, og 122 patienter blev behandlet med entacapon 200 mg (aktiv komparator).
English: The effects of opicapone on fertility in humans have not been studied.
Danish: Opicapons indvirkning på fertiliteten hos mennesker er ikke undersøgt.
English: The most common adverse reactions reported were nervous system disorders.
Danish: De hyppigst rapporterede bivirkninger var symptomer fra nervesystemet.
English: Table 1 - Frequency of adverse reactions (MedDRA) in placebo-controlled Phase 3 studies System Organ Class
Danish: Tabel 1- Hyppigheden af bivirkninger (MedDRA) i placebokontrollerede fase 3-studier Systemorganklasse
English: Patients should be monitored regularly for the development of impulse control disorders and review of treatment is recommended if such symptoms develop.
Danish: Patienten skal monitoreres tæt for udvikling af symptomer på manglende impulskontrol, og revurdering af behandlingen anbefales, hvis patienten udvikler sådanne symptomer.
English: The SCOMT activity inhibition was significantly increased in elderly subjects.
Danish: Hæmning af SCOMT-aktiviteten var signifikant øget hos ældre forsøgspersoner.
English: CYP2C8 and OATP1B1 substrates
Danish: CYP2C8- og OATP1B1-substrater
English: If you forget to take one dose, you should continue the treatment and take the next dose as scheduled.
Danish: Hvis du glemmer at tage en dosis, skal du fortsætte behandlingen og tage næste dosis som planlagt.
English: Thus, particular consideration should be given to cases where quinidine needs to be administered together with opicapone as their co-administration should be avoided.
Danish: Der bør derfor udvises særlig forsigtighed i tilfælde, hvor det er nødvendigt at administrere kinidin samtidig med opicapon, da samtidig administration bør undgås.
English: Talk to your doctor or pharmacist if you or your family/carer notices you are developing urges or cravings to behave in ways that are unusual for you or you cannot resist the impulse, drive or temptation to carry out certain activities that could harm you or others.
Danish: Kontakt lægen eller apotekspersonalet, hvis du eller din familie/plejeansvarlige bemærker, at du udvikler lyst eller trang til at udføre handlinger, som er usædvanlige for dig, eller hvis du ikke kan modstå impulser, drifter eller fristelser til at udføre bestemte aktiviteter, som kan skade dig eller andre.
English: Opicapone enhances the effects of levodopa.
Danish: Opicapon forstærker virkningen af levodopa.
English: Pharmacotherapeutic group: Anti-parkinson drugs, other dopaminergic agents, ATC code: [not yet assigned]
Danish: Farmakoterapeutisk klassifikation: antiparkinsonmidler, andre dopaminerge lægemidler, ATC-kode: [endnu ikke tildelt]
English: a. ON-time without troublesome dyskinesias=ON-time with non-troublesome dyskinesias + ON-time without dyskinesias
Danish: a. ON-tid uden generende dyskinesier = ON-tid med ikke-generende dyskinesier + ON-tid uden dyskinesier
English: Ask your doctor or pharmacist if you can take your antidepressant together with Ongentys.
Danish: Spørg din læge eller apotekspersonalet, om du kan tage din medicin mod depression sammen med Ongentys.
English: The majority of patients treated in both pivotal studies were treated with immediate-release levodopa/DDCI.
Danish: Størstedelen af de behandlede patienter i de 2 pivotalstudier blev behandlet med levodopa/DDCI med øjeblikkelig frigivelse.
English: The reduced metabolite of opicapone (found to be active in non-clinical studies) is a minor metabolite in human plasma, and represented less than 10% of total systemic exposure to opicapone.
Danish: Metabolitten dannet ved reduktion af opicapon (fundet at være aktiv i ikke-kliniske studier) er en mindre væsentlig metabolit i humant plasma og stod for mindre end 10 % af den samlede systemiske eksponering af opicapon.
English: The difference in LS mean change in OFF-time of entacapone to placebo in Study 1 was -30.5 minutes.
Danish: Forskellen i gennemsnitlig ændring (LS) i OFF-tid mellem entacapon og placebo i studie 1 var -30,5 minutter.
English: In the table below (Table 1) all adverse reactions are presented by System Organ Class and frequency.
Danish: I nedenstående tabel (tabel 1) er alle bivirkninger opstillet efter systemorganklasse og hyppighed.
English: Other metabolites were not found in quantifiable concentrations in the majority of plasma samples collected during a clinical mass balance study.
Danish: Der blev ikke fundet andre metabolitter i kvantificerbare koncentrationer i størstedelen af de plasmaprøver, der blev indsamlet i et klinisk massebalance-studie.
English: Caution must be exercised in these patients and dose adjustment may be necessary (see section
Danish: Der skal udvises forsigtighed hos disse patienter, og dosisjustering kan være nødvendig (se pkt.
English: Non-clinical data revealed no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity and carcinogenic potential.
Danish: Prækliniske data viser ingen speciel risiko for mennesker vurderet ud fra konventionelle studier af sikkerhedsfarmakologi, toksicitet efter gentagne doser, genotoksicitet og karcinogenicitet.
English: In urine, the primary metabolite was the glucuronide metabolite of opicapone, while parent drug and other metabolites were generally below the limit of quantification.
Danish: I urinen var den primære metabolit glukuronidmetabolitten af opicapon, mens uomdannet lægemiddel og andre metabolitter generelt var under kvantificeringsgrænsen.
English: Careful monitoring of patients being treated with these medicinal products is advised when opicapone is used.
Danish: Der tilrådes tæt monitorering af patienter, som behandles med disse lægemidler, når opicapon anvendes.
English: In pregnant rabbits, opicapone was less well tolerated resulting in maximum systemic exposure levels around or below the therapeutic range.
Danish: Hos drægtige kaniner var opicapon mindre veltolereret, hvilket resulterede i maksimale niveauer af systemisk eksponering omkring eller under det terapeutiske område.
English: In the presence of a DOPA decarboxylase inhibitor (DDCI), COMT becomes the major metabolising enzyme for levodopa, catalysing its conversion to 3-O-methyldopa (3-OMD) in the brain and periphery.
Danish: Ved tilstedeværelse af en DOPA-decarboxylasehæmmer (DDCI) bliver COMT det vigtigste enzym for metabolisering af levodopa og katalyserer dets omdannelse til 3-O-methyldopa (3-OMD) i hjernen og perifert.
English: In patients taking levodopa and a peripheral DDCI, such as carbidopa or benserazide, opicapone increases levodopa plasma levels thereby improving the clinical response to levodopa.
Danish: Hos patienter, som tager levodopa og en perifer DDCI som f.eks. carbidopa eller benserazid, øger opicapon levodopa-plasmaniveauet og forbedrer derved det kliniske respons på levodopa.
English: Ongentys is a medicine that contains the active substance opicapone.
Danish: Ongentys er et lægemiddel, der indeholder det aktive stof opicapon.
English: The results of the open-label (OL) extension studies of 1 year duration in 862 patients who continued treatment from the double-blind studies (Study 1-OL and Study 2-OL) indicated maintenance of the effect achieved during DB study periods.
Danish: Resultaterne fra de åbne (OL) forlængelsesstudier af 1 års varighed med 862 patienter, der fortsatte behandling fra de dobbeltblinde studier (studie 1-OL og studie 2-OL), indikerede vedligeholdelse af virkningen opnået i løbet af de dobbeltblinde studieperioder.
English: However, as opicapone is to be used as adjunctive levodopa-therapy, dose adjustments may be considered based on a potentially enhanced levodopa dopaminergic response and associated tolerability.
Danish: Da opicapon imidlertid bruges som supplement til levodopa-behandling, kan dosisjustering overvejes baseret på en potentielt øget dopaminerg respons på levodopa og dertil knyttet tolerabilitet.
English: The binding of 14C-opicapone to plasma proteins was unaffected by the presence of warfarin, diazepam, digoxin and tolbutamide, and the binding of 14C-warfarin, 2-14C-diazepam, 3H-digoxin and 14C-tolbutamide was unaffected by the presence of opicapone and opicapone sulphate, the major human metabolite.
Danish: Bindingen af 14C-opicapon til plasmaproteiner blev ikke påvirket af warfarin, diazepam, digoxin og tolbutamid, og bindingen af 14C-warfarin, 2-14C-diazepam, 3H-digoxin og 14C-tolbutamid blev ikke påvirket af opicapon og opicaponsulfat, den vigtigste humane metabolit.
English: It increases the effects of levodopa and helps to relieve the symptoms of Parkinson's disease and movement problems.
Danish: Lægemidlet øger levodopas virkning og hjælper til at mindske symptomerne på Parkinsons sygdom og bevægelsesproblemer.
English: Taking Ongentys with these medicines may increase the risk of side effects.
Danish: Hvis du tager Ongentys sammen med disse lægemidler, kan det øge risikoen for bivirkninger.
English: Some side effects may be caused by the increased effects of using Ongentys together with levodopa.
Danish: Nogle af bivirkningerne kan skyldes den øgede virkning ved samtidig brug af Ongentys og levodopa.
English: Since the risk to the baby/infant cannot be excluded, you should stop breast-feeding during treatment with Ongentys.
Danish: Da en risiko for spædbarnet ikke kan udelukkes, skal du stoppe med at amme, mens du er i behandling med Ongentys.
English: Opicapone presents a low absorption (~20%).
Danish: Opicapon udviser lav absorption (ca. 20 %).
English: CI = confidence interval; N = total number of patients; n = number of patients with available information; NA = not applicable; OPC = opicapone
Danish: CI = konfidensinterval, N = samlet antal patienter, n = antal patienter med tilgængelige oplysninger, NA = ikke relevant, OPC = opicapon
English: Abnormal dreams, Hallucination, Hallucination visual, Insomnia
Danish: Unormale drømme, hallucinationer, visuelle hallucinationer, insomni
English: Doses of other medicines to treat Parkinson's disease
Danish: Doser af anden medicin til behandling af Parkinsons sygdom
English: Patients had disease severity stages 1 to 3 (modified Hoehn and Yahr) at ON, were treated with 3 to 8 daily doses of levodopa/DDCI and had a daily average OFF-time of at least 1.5 hours.
Danish: Patienterne havde sygdomsfase 1 til 3 (modificeret Hoehn og Yahr) ved ON, blev behandlet med 3 til 8 daglige doser levodopa/DDCI og havde en daglig OFF-tid på mindst 1,5 time.
English: In vitro studies over the opicapone concentration range 0.3 to 30 mcg/mL showed that binding of 14C-opicapone to human plasma proteins is high (99.9%) and concentration-independent.
Danish: In vitro-studier i opicapon-koncentrationsintervallet 0,3 til 30 mikrog/ml viste, at bindingen af 14C-opicapon til humane plasmaproteiner er høj (99,9 %) og koncentrationsuafhængig.
English: Ongentys contains lactose
Danish: Ongentys indeholder lactose
English: As Ongentys will be used with other levodopa medicines, please also read the package leaflets of these medicines carefully.
Danish: Da Ongentys vil blive brugt sammen med lægemidler, der indeholder levodopa, skal du også læse indlægssedlerne for disse lægemidler nøje.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING BOX (BLISTER OPA/Al/PVC//Al)
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE ÆSKE (BLISTER OPA/Al/PVC//Al)