FrancophonIA/ELRC3.0 huggingface dataset:
English: A predefined retrospective subset analysis of 641 patients of the 656 patients with wild-type KRAS (exon 2) mCRC was performed.
Danish: Der blev udarbejdet en forud defineret, retrospektiv undergruppeanalyse af 641 patienter ud af de 656 patienter med vildtype-KRAS (exon 2) mCRC.
English: Colourless, pH 5.6 to 6.0 solution that may contain translucent to white, visible amorphous, proteinaceous panitumumab particles.
Danish: Farveløs opløsning med en pH-værdi på 5,6 til 6,0, der kan indeholde halvgennemsigtige til hvide, synlige amorfe proteinlignende panitumumab-partikler.
English: 4817 ZK Breda The Netherlands
Danish: 4817 ZK Breda Nederlandene
English: These reactions are related to the pharmacologic effects of Vectibix, and the majority are mild to moderate in nature with 23% severe (grade 3 NCI-CTC) and < 1% life-threatening (grade 4 NCI-CTC).
Danish: Disse reaktioner er relateret til Vectibix farmakologiske virkninger, og størstedelen er milde til moderate af beskaffenhed med 23 % alvorlige (grad 3 NCI-CTC) og < 1 % livstruende (grad 4 NCI-CTC).
English: A reduction in the rate of infusion of Vectibix may be necessary in cases of infusion-related reactions (see section 4.4).
Danish: Det kan være nødvendigt at nedsætte infusionshastigheden af Vectibix i tilfælde af infusionsrelaterede reaktioner (se pkt.
English: No anti-tumour effects of panitumumab were observed in human tumour xenografts lacking EGFR expression.
Danish: Der blev ikke observeret nogen anti-tumor-virkninger af panitumumab i humane tumorxenografter, der manglede EGFR-ekpression.
English: • in first-line in combination with FOLFOX or FOLFIRI.
Danish: • som første-linje-behandling i kombination med FOLFOX eller FOLFIRI.
English: • severe skin reaction with blistering of the skin (toxic epidermal necrolysis);
Danish: • alvorlig hudreaktion med blærer på huden (toksisk epidermal nekrolyse)
English: Treatment and management of dermatologic reactions should be based on severity and may include a moisturiser, sun screen (SPF > 15 UVA and UVB), and topical steroid cream (not stronger than 1% hydrocortisone) applied to affected areas, and/or oral antibiotics (e.g. doxycycline).
Danish: Behandling og håndtering af dermatologiske reaktioner skal baseres på sværhedsgraden og kan omfatte applikation af fugtighedscreme, solbeskyttelsescreme (SPF > 15 UVA og UVB) og steroidcreme (ikke stærkere end 1 % hydrocortison) på de afficerede hudområder og/eller orale antibiotika (f.eks. doxycyclin).
English: Patients receiving Vectibix in combination with the IFL regimen [bolus 5-fluorouracil (500 mg/m2), leucovorin (20 mg/m2) and irinotecan (125 mg/m2)] experienced a high incidence of severe diarrhoea (see section 4.8).
Danish: Patienter, der fik Vectibix sammen med IFL-regimenet [bolus 5-fluoruracil (500 mg/m2), leucovorin (20 mg/m2) og irinotecan (125 mg/m2)], havde en høj forekomst af alvorlig diaré (se pkt.
English: The hazard ratio for overall survival was 1.43 (95% CI: 1.11, 1.83).
Danish: Hazard ratio for generel overlevelse var 1,43 (95 % CI: 1,11; 1,83).
English: Skin rash and diarrhoea were the major findings observed in repeat-dose toxicity studies of up to 26 weeks duration in cynomolgus monkeys.
Danish: Hududslæt og diaré var de væsentligste fund, der blev observeret i toksicitetsstudier med gentagen dosis af op til 26 ugers varighed i cynomolgusaber.
English: Very rarely, serious allergic (hypersensitivity) reactions involving symptoms similar to an infusion reaction (see “Infusion reactions”) have occurred more than 24 hours after treatment and resulted in a fatal outcome.
Danish: Der er i meget sjældne tilfælde opstået alvorlige allergiske reaktioner (overfølsomhedsreaktioner) med symptomer svarende til en infusionsreaktion (se "Infusionsrelaterede reaktioner") mere end 24 timer efter behandlingen, som har haft fatalt udfald.
English: Vectibix must be administered as an intravenous infusion via an infusion pump.
Danish: Vectibix skal indgives som en intravenøs infusion via en infusionspumpe.
English: Vectibix should be used with caution in patients with a history of keratitis, ulcerative keratitis or severe dry eye.
Danish: Vectibix skal anvendes med forsigtighed til patienter med keratitis, ulcerativ keratitis eller alvorlig øjentørhed i anamnesen.
English: Shortened progression-free survival time and increased deaths were observed in the patients receiving Vectibix in combination with bevacizumab and chemotherapy.
Danish: Der blev observeret kortere progressionsfri overlevelsestid og forøget antal dødsfald hos patienter, der fik Vectibix sammen med bevacizumab og kemoterapi.
English: The study was retrospectively analysed by wild-type KRAS (exon 2) status versus mutant KRAS (exon 2) status.
Danish: Studiet blev analyseret retrospektivt efter vildtype-KRAS-status (exon 2) vs. muteret KRAS-status (exon 2).
English: Patients with ECOG 2 performance status treated with Vectibix in combination with chemotherapy
Danish: Patienter i ECOG-performance-status 2, som behandles med Vectibix i kombination med kemoterapi
English: Withhold or discontinue Vectibix in the event of dermatologic or soft tissue toxicity associated with severe or life-threatening inflammatory or infectious complications.
Danish: Behandling med Vectibix skal udsættes eller seponeres helt i tilfælde af dermatologisk toksicitet eller bløddelstoksicitet i forbindelse med alvorlige eller livstruende inflammatoriske eller infektiøse komplikationer.
English: Moreover, panitumumab treatment was associated with improved PFS compared to BSC in patients with wild-type RAS tumours (HR = 0.38 [95% CI: 0.27, 0.56]), but not in patients with tumours harbouring a RAS mutation (HR = 0.98 [95% CI: 0.73, 1.31]).
Danish: Desuden var behandling med panitumumab forbundet med bedre PFS sammenlignet med BSC hos patienter med vildtypeRAS-tumorer (HR = 0,38 [95 % CI: 0,27; 0,56]), men ikke hos patienter med tumorer, der skjulte en RAS-mutation (HR = 0,98 [95 % CI: 0,73; 1,31]).
English: Difference (months)
Danish: Forskel (mdr.)
English: A case of fatal angioedema occurred in a patient with recurrent and metastatic squamous cell carcinoma of the head and neck treated with Vectibix in a clinical trial.
Danish: Et tilfælde med letalt angioødem forekom hos en patient med recidiverende og metastatisk skvamøs cellecarcinom i hoved og hals behandlet med Vectibix i et klinisk studie.
English: For patients with ECOG 2 performance status, assessment of benefit-risk is recommended prior to initiation of Vectibix in combination with chemotherapy for treatment of mCRC.
Danish: For patienter i ECOG-performance-status 2 anbefales en vurdering af risici kontra fordele inden initiering af behandling med Vectibix i kombination med kemoterapi til behandling af mCRC.
English: • cough; dyspnoea (breathing difficulties).
Danish: • hoste, dyspnø (åndedrætsbesvær)
English: Therefore, Vectibix has the potential to cause foetal harm when administered to pregnant women.
Danish: Derfor kan Vectibix forårsage føtal skade, når det indgives til gravide kvinder.
English: • ulcerative keratitis (a serious condition of ulceration of the front part of the eye (cornea)
Danish: • ulcerativ keratitis (en alvorlig tilstand med sårdannelse i den forreste del af øjet (hornhinden),
English: Upon disease progression BSC alone patients were eligible to crossover to a companion study and receive Vectibix at a dose of 6 mg/kg given once every two weeks.
Danish: Ved sygdomsprogression kunne patienterne, der fik BSC alene, fortsætte i et sideløbende studie og få Vectibix ved en dosis på 6 mg/kg indgivet én gang hver anden uge.
English: Blepharitis
Danish: Blefaritis
English: Vectibix treatment should be supervised by a physician experienced in the use of anti-cancer therapy.
Danish: Behandling med Vectibix skal superviseres af en læge, der er erfaren i anvendelsen af anticancerterapi.
English: Vectibix in combination with irinotecan, bolus 5-fluorouracil, and leucovorin (IFL) chemotherapy
Danish: Vectibix kombineret med irinotecan-, bolus 5-fluoruracil og leucovorin-holdig (IFL) kemoterapi
English: It is also recommended that patients experiencing rash/dermatological toxicities wear sunscreen and hats and limit sun exposure as sunlight can exacerbate any skin reactions that may occur.
Danish: Det anbefales desuden, at patienter, der oplever udslæt/hudtoksicitet, anvender solbeskyttelsescreme og hat samt begrænser soleksponering, da sollys kan forværre eventuelle hudreaktioner.
English: Other toxicities that were observed with a greater frequency relative to monotherapy included hypomagnesaemia, diarrhoea, and stomatitis.
Danish: Andre bivirkninger, der blev observeret med større hyppighed i forhold til monoterapi, var hypomagnesiæmi, diaré og stomatitis.
English: The European Medicines Agency has waived the obligation to submit the results of studies with Vectibix in all subsets of the paediatric population in colorectal cancer (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har dispenseret fra kravet om at fremlægge resultaterne af studier med Vectibix i alle undergrupper af den pædiatriske population med kolorektal cancer (se pkt.
English: The efficacy of Vectibix was also evaluated in an open-label trial in patients with wild-type KRAS (exon 2) mCRC.
Danish: Effekten af Vectibix blev desuden undersøgt i et open-label studie med patienter med vildtype-KRAS-mCRC (exon 2).
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each mL of concentrate contains 20 mg panitumumab.
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Hver ml koncentrat indeholder 20 mg panitumumab.
English: Panitumumab binds to the ligand binding domain of EGFR and inhibits receptor autophosphorylation induced by all known EGFR ligands.
Danish: Panitumumab binder til EGFR's ligandbindende domæne og hæmmer receptor-autofosforylering, der induceres af alle kendte EGFR-ligander.
English: The diluted solution must not be frozen.
Danish: Den fortyndede infusionsvæske må ikke nedfryses.
English: Median PFS was 10.0 (95% CI: 8.9, 11.0) and 11.4 (95% CI: 10.5, 11.9) months in the panitumumab and the non-panitumumab arm, respectively.
Danish: Median-PFS var 10,0 (95 % CI: 8,9; 11,0) og 11,4 (95 % CI: 10,5; 11,9) måneder i henholdsvis panitumumab-armen og ikke-panitumumab-armen.
English: Panitumumab may impact the ability of a woman to become pregnant.
Danish: Panitumumab kan måske påvirke kvinders evne til at blive gravide.
English: Your doctor may decide to reduce the rate of your infusion or discontinue your treatment with Vectibix.
Danish: Deres læge kan beslutte at nedsætte infusionshastigheden eller standse Deres behandling med Vectibix.
English: was < 1%;
Danish: var cirka 19 %.
English: The skin rash commonly resembles acne and often involves the face, upper chest and back, but can affect any area of the body.
Danish: Hududslættet ligner ofte acne og rammer ansigtet, den øverste del af brystet og ryggen, men kan også opstå andre steder på kroppen.
English: Overall, panitumumab treatment combined with chemotherapy and bevacizumab is associated with an unfavourable benefit-to-risk profile irrespective of tumour KRAS mutational status.
Danish: Overordnet set er panitumumab-behandling kombineret med kemoterapi og bevacizumab associeret med en ugunstig benefit/risk-profil uanset tumors KRAS-mutationsstatus.
English: Discard the vial and any liquid remaining in the vial after the single-use.
Danish: Kassér hætteglasset og eventuel resterende væske i hætteglasset efter engangsbrug.
English: Clinical efficacy in combination with chemotherapy
Danish: Klinisk virkning ved kombination med kemoterapi
English: Blood magnesium decreased
Danish: Nedsat blodmagnesium
English: The recommended dose of Vectibix is 6 mg/kg (milligrams per kilogram of body weight) given once every two weeks.
Danish: Den anbefalede dosis Vectibix er 6 mg/kg (milligram pr. kg legemsvægt), som indgives én gang hver anden uge.
English: Hypersensitivity reactions occurring more than 24 hours after infusion have been reported including a fatal case of angioedema that occurred more than 24 hours after the infusion.
Danish: Der er indberettet overfølsomhedsreaktioner, som er opstået mere end 24 timer efter infusionen, herunder et letalt tilfælde af angioødem, der opstod mere end 24 timer efter infusionen.
English: Tell your doctor if you use contact lenses and/or have a history of eye problems such as severe dry eye, inflammation of the front part of the eye (cornea) or ulcers involving the front part of the eye.
Danish: Fortæl lægen, hvis De bruger kontaktlinser og/eller tidligere har haft øjenproblemer, for eksempel alvorlig øjentørhed eller betændelse eller sår i den forreste del af øjet.
English: Vectibix will be administered in a healthcare facility under the supervision of a doctor experienced in the use of anti-cancer medicines.
Danish: Vectibix vil blive indgivet på et hospital under tilsyn af en læge, der har erfaring med anvendelsen af medicin mod cancer.
English: Infusion-related reaction1
Danish: Infusionsrelateret reaktion1
English: The incidence of BRAF exon 15 mutation in the wild-type KRAS (exon 2) population was approximately 8%.
Danish: Forekomsten af BRAF-exon 15-mutation i populationen med vildtype-KRAS (exon 2) var cirka 8 %.
English: Hypocalcaemia Dehydration Hyperglycaemia Hypophosphataemia
Danish: Hypokalcæmi Dehydrering Hyperglykæmi Hypofosfatæmi
English: Initial occurrence Withhold 1 or 2 doses
Danish: Første gang Tilbagehold 1 eller 2 doser
English: The safety profile of Vectibix in combination with chemotherapy consisted of the reported adverse reactions of Vectibix (as a monotherapy) and the toxicities of the background chemotherapy regimen.
Danish: Sikkerhedsprofilen for Vectibix i kombination med kemoterapi var sammensat af de indberettede bivirkninger for Vectibix (som monoterapi) og toksiciteten af det bagvedliggende kemoterapi-regime.
English: The efficacy of Vectibix as monotherapy in patients with metastatic colorectal cancer (mCRC) who had disease progression during or after prior chemotherapy was studied in open-label, single-arm trials (585 patients) and in two randomised controlled trials versus best supportive care (463 patients) and versus cetuximab (1,010 patients).
Danish: Effekten af Vectibix som monoterapi hos patienter med metastatisk kolorektal cancer, mCRC, der havde sygdomsprogression under eller efter tidligere kemoterapi, blev undersøgt i open-label, enkeltgruppe-studie (585 patienter) og i to randomiserede, kontrollerede studier vs. bedste understøttende behandling (463 patienter) og vs. cetuximab (1.010 patienter).
English: A shortened progression-free survival (PFS) and overall survival (OS) time were observed in patients with mutant KRAS (exon 2) tumours and additional RAS mutations (KRAS [exons 3 and 4] or NRAS [exons 2, 3, 4]) who received panitumumab in combination with infusional 5-fluorouracil, leucovorin, and oxaliplatin (FOLFOX) versus FOLFOX alone (see section 5.1).
Danish: Der blev observeret en kortere progressionsfri (PFS) tid og total overlevelsestid (OS) hos patienter med tumorer med muteret KRAS (exon 2) og yderligere RAS-mutationer (KRAS [exon 3 og 4] eller NRAS [exon 2, 3, 4]), der fik panitumumab i kombination med infusionrelateret 5-fluoruracil, leucovorin og oxaliplatin (FOLFOX) vs. FOLFOX alene (se punkt 5.1).
English: The product should be used immediately after dilution.
Danish: Efter fortynding skal lægemidlet anvendes straks.
English: No clinical studies have been conducted to examine the pharmacokinetics of panitumumab in patients with renal or hepatic impairment.
Danish: Der er ikke udført nogen kliniske studier med henblik på at undersøge panitumumabs farmakokinetik hos patienter med nyre- eller leversvækkelse.
English: Common: may affect up to 1 in 10 people
Danish: Almindelige: kan ramme op til 1 ud af 10 personer
English: The diluted solution should be mixed by gentle inversion, do not shake.
Danish: Den fortyndede opløsning skal blandes ved forsigtigt at vende den om.
English: Patients presenting with signs and symptoms suggestive of keratitis such as acute or worsening: eye inflammation, lacrimation, light sensitivity, blurred vision, eye pain and/or red eye should be referred promptly to an ophthalmology specialist.
Danish: Patienter med tegn og symptomer, der tyder på keratitis (for eksempel akut opstået eller forværring af øjeninflammation, tåreflåd, lysfølsomhed, sløret syn, øjensmerter og/eller røde øjne), bør straks henvises til en øjenlæge.
English: Your doctor may ask you to use a moisturiser, sun screen (SPF > 15), topical steroid, and/or oral antibiotics which may help in the management of skin toxicities that can be associated with the use of Vectibix.
Danish: Deres læge vil muligvis råde Dem til at bruge fugtighedscreme, solbeskyttelsescreme (solfaktor > 15), steroidcreme og/eller orale antibiotika, der kan være en hjælp i håndteringen af de hudbivirkninger, som kan være forbundet med anvendelsen af Vectibix.
English: • headache; dizziness; anxiety.
Danish: • hovedpine, svimmelhed, angst
English: The fatal event occurred after re-exposure following a prior episode of angioedema; both episodes occurred greater than 24 hours after administration (see sections 4.3 and 4.4).
Danish: Den letale hændelse indtraf efter re-eksponering efter en forudgående episode med angioødem; begge episoder indtraf mere end 24 timer efter indgift (se pkt.
English: Vectibix is a colourless liquid that may contain visible particles and is supplied in a glass vial.
Danish: Vectibix er en farveløs væske, der kan indeholde synlige partikler.
English: In the post-marketing setting, serious infusion-related reactions have been reported, including rare post-marketing reports with a fatal outcome.
Danish: Efter markedsføring af præparatet er der indberettet alvorlige infusionsrelaterede reaktioner, herunder sjældne indberetninger med letalt udfald.
English: • in combination with oxaliplatin-based chemotherapy, if your RAS test shows that you have mutant RAS tumour, or if your RAS tumour status is unknown.
Danish: • i kombination med oxaliplatin-baseret kemoterapi, hvis Deres RAS-test viser, at De har tumor med muteret RAS, eller hvis Deres RAS-tumorstatus er ukendt.
English: The most increased serious adverse events included diarrhoea in patients treated with Vectibix in combination with either FOLFOX or FOLFIRI, and dehydration and pulmonary embolism when patients were treated with Vectibix in combination with FOLFIRI.
Danish: De alvorlige bivirkninger, der havde den største stigning, var blandt andet diaré hos patienter, der blev behandlet med Vectibix i kombination med enten FOLFOX eller FOLFIRI, samt dehydrering og lungeemboli hos patienter, der blev behandlet med Vectibix i kombination med FOLFIRI.
English: • in second-line in combination with FOLFIRI for patients who have received first-line fluoropyrimidine-based chemotherapy (excluding irinotecan).
Danish: • som anden-linje-behandling i kombination med FOLFIRI til patienter, der har fået første-linje behandling med fluorpyrimidin-baseret kemoterapi (bortset fra irinotecan).
English: Rash pustular Cellulitis1
Danish: Pustuløst udslæt Cellulitis1
English: Withhold 1 or 2 doses
Danish: Anden gang Tilbagehold 1 eller 2 doser
English: Mutant RAS population PFS
Danish: Population med muteret RAS PFS
English: The incidence of these additional RAS mutations in the wild-type KRAS exon 2 population was approximately 16%.
Danish: Forekomsten af disse yderligere RAS-mutationer i populationen med vildtype-KRAS exon 2 var cirka 16 %.
English: There have been reports of acute renal failure in patients who develop diarrhoea and dehydration (see section 4.4).
Danish: Der er rapporteret akut nyresvigt hos patienter, som udvikler diaré og dehydrering (se pkt.
English: Anaphylactic reaction2
Danish: Anafylaktisk reaktion2
English: Panitumumab is a fully human monoclonal IgG2 antibody produced in a mammalian cell line (CHO) by recombinant DNA technology.
Danish: Panitumumab er et 100 % humant monoklonalt IgG2-antistof, der er produceret i en pattedyrscellelinje (CHO) vha. rekombinant DNA-teknologi.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 3 December 2007
Danish: DATO FOR FØRSTE MAKEDSFØRINGSTILLADELSE/FORNYELSE AF TILLADELSEN
English: The skin rash and diarrhoea observed in monkeys are considered related to the pharmacological action of panitumumab and are consistent with the toxicities observed with other anti-EGFR inhibitors.
Danish: Hududslættet og diaréen, der blev observeret hos aber, betragtes som værende relateret til panitumumabs farmakologiske virkning og svarer til de toksiciteter, der er observeret med andre anti-EGFR-hæmmere.
English: Serious cases of keratitis and ulcerative keratitis have been rarely reported in the post-marketing setting.
Danish: Der er i sjældne tilfælde indberettet alvorlige tilfælde af keratitis og ulcerativ keratitis efter markedsføring af produktet.
English: Urinary tract infection Folliculitis
Danish: Urinvejsinfektion Folliculitis Lokaliseret infektion
English: Severe diarrhoea (NCI-CTC grade 3 and 4) was reported in 2% of patients treated with Vectibix as a monotherapy and in 16% of patients treated with Vectibix in combination with chemotherapy.
Danish: Der blev indberettet alvorlig diaré (NCI-CTC grad 3 og 4) hos 2 % af de patienter, der blev behandlet med Vectibix som monoterapi, og hos 16 % af de patienter, der blev behandlet med Vectibix i kombination med kemoterapi.
English: In clinical studies, subsequent to the development of severe dermatologic reactions (including stomatitis), infectious complications including sepsis and necrotising fasciitis, in rare cases leading to death, and local abscesses requiring incisions and drainage were reported.
Danish: Der blev i kliniske studier, efter udvikling af alvorlige dermatologiske reaktioner (herunder stomatitis), rapporteret infektiøse komplikationer, herunder sepsis og nekrotiserende fasciitis, i sjældne tilfælde med døden til følge, samt lokale abscesser, hvor incisioner og drænage var påkrævet.
English: Also, dry skin, fissures (cracks in the skin) on the fingers or toes, fingernail bed or toenail bed infection (paronychia) or inflammation has been reported.
Danish: Desuden er der indberettet tør hud, revner i huden (hudfissurer) på fingre eller tæer, infektion eller inflammation i neglelejerne på fingre eller tæer (paronychia).
English: Median (months) (95% CI) Hazard ratio (95% CI) ORR n (%) (95% CI) Odds ratio (95% CI)
Danish: Median (måneder) (95 % CI) Hazard ratio (95 % CI) ORR n (%) (95 % CI) Odds ratio (95 % CI)
English: Patients with interstitial pneumonitis or pulmonary fibrosis (see section 4.4).
Danish: Patienter med interstitiel pneumonitis eller lungefibrose (se pkt.
English: In a randomised, open-label, controlled clinical trial, chemotherapy (oxaliplatin or irinotecan) and bevacizumab were given with and without panitumumab in the first-line treatment of patients with metastatic colorectal cancer (n = 1,053 [n = 823 oxaliplatin cohort, n = 230 irinotecan cohort]).
Danish: I et randomiseret, åbent, kontrolleret klinisk studie blev der givet kemoterapi (oxaliplatin eller irinotecan) og bevacizumab med og uden panitumumab som første-linje-behandling til patienter med metastatisk kolorektal cancer (n = 1.053 [n = 823 oxaliplatin-kohorte, n = 230 irinotecan-kohorte]).
English: Do not use needle-free devices (e.g. vial adapters) to withdraw vial contents.
Danish: Brug ikke nålefrie anordninger (f.eks. hætteglasadaptere) til udtagning af hætteglassets indhold.
English: Based on an analysis of all mCRC clinical trial patients receiving Vectibix monotherapy and in combination with chemotherapy (n = 2,224), the most commonly reported adverse reactions are skin reactions occurring in approximately 94% of patients.
Danish: Baseret på en analyse af alle patienter i kliniske mCRC-studier, der har fået Vectibix som monoterapi eller i kombination med kemoterapi (n = 2.224), er de hyppigst rapporterede bivirkninger hudreaktioner, der forekommer hos cirka 94 % af patienterne.
English: Amgen Europe B.V. Minervum 7061, 4817 ZK Breda, The Netherlands
Danish: Minervum 7061, 4817 ZK Breda, Nederlandene
English: x1 vial
Danish: x1 hætteglas
English: Clinical efficacy as monotherapy
Danish: Klinisk virkning som monoterapi