FrancophonIA/ELRC3.0 huggingface dataset:
English: Whilst no overgrowth by opportunistic microorganisms such as yeasts were noted during the clinical studies with ORACEA, therapy with tetracyclines at higher doses may result in overgrowth of nonsusceptible microorganisms including fungi.
Danish: Selv om der ikke blev bemærket nogen overvækst af opportunistiske mikroorganismer, såsom gær, under de kliniske forsøg med ORACEA, kan behandling med tetracykliner ved højere doser resultere i overvækst af ikke-påvirkelige mikroorganismer, herunder svampe.
English: SPECIAL STORAGE CONDITIONS Store in the original package in order to protect from light.
Danish: SÆRLIGE OPBEVARINGSBETINGELSER Opbevares i den originale emballage for at beskytte mod lys.
English: At doses greater than 50 mg/kg/day fertility and reproductive performance were adversely affected in rats.
Danish: Doser højere end 50 mg/kg/dag havde en ugunstig virkning på fertiliteten og reproduktiviteten hos rotterne.
English: The Applicant also presented data from six placebocontrolled studies conducted in over 400 patients, showing no evidence of increase in resistance of the microbiological flora of the gastrointestinal tract (faeces), vagina, skin, saliva or dental plaque after long-term treatment with doxycycline 40 mg/day for 6 to 18 months, which is in line with pharmacokinetic investigations on target site exposure.
Danish: Ansøgeren præsenterede også data fra seks placebokontrollerede undersøgelser, der blev udført på 400 patienter, og som ikke viste en øget resistens i mikrofloraen i mavetarmsystemet (fæces) vagina, spyt eller dentale plaque efter langvarig behandling med 40 mg doxycyclin om dagen i 6 til 8 måneder, hvilket passer med farmakokinetiske undersøgelser af eksponering på målstedet.
English: Sub-therapeutic doxycycline concentrations may result.
Danish: Dette kan resultere i subterapeutiske doxycyclinkoncentrationer.
English: A double-blind, placebo controlled study by Walker et al, 2005 studying the effect of 20 mg doxycycline bid did not show any statistically significant differences between the active group and the placebo group in terms of emergence of doxycycline- or multidrug-resistant bacteria in faecal or vaginal samples.
Danish: Et dobbeltblindt, placebokontrolleret studie, foretaget af Walker et al. 2005 undersøgte virkningen af 20 mg doxycyclin, men påviste ingen statistisk signifikante forskelle mellem gruppen, der fik det aktive stof og gruppen, der fik placebo, med hensyn til fremkomst af doxycyclinresistente og multilægemiddelresistente bakterier i fæcesprøver og prøver fra vagina.
English: ORACEA must not be taken by infants or children under the age of 12, because it may cause permanent discolouration of the teeth or problems with tooth development.
Danish: ORACEA må ikke tages af spædbørn og børn under 12 år, da det kan medføre permanent misfarvning af tænderne eller problemer med tandudviklingen.
English: Doxycycline is known to cross the placenta and literature data indicate that tetracyclines can have toxic effects on the developing fetus.
Danish: Doxycyclin har vist sig at krydse placenta, og data i litteraturen antyder, at tetracykliner kan have toksiske virkninger på det udviklende foster.
English: Doxycycline, generally in the dose of 100-200 mg daily, has been widely used in clinical practice for the treatment of various infectious diseases for more than 25 years, with a well documented safety profile.
Danish: Doxycyclin, normalt i daglige doser på 100-200 mg, har de sidste 25 år ofte været brugt i klinikken til behandling af forskellige infektioner og har en veldokumenteret sikkerhedsprofil.
English: Do not take a double dose to make up for a forgotten capsule.
Danish: Hvis De har glemt at tage ORACEA De må ikke tage en dobbeltdosis som erstatning for den glemte kapsel.
English: Bacteriostatic medicinal products including doxycycline may interfere with the bacteriocidal action of penicillin and beta-lactam antibiotics.
Danish: Bakteriostatiske lægemidler, herunder doxycyclin, kan interferere med penicillins og betalaktamantibiotikas bakteriedræbende virkning.
English: Taking barbiturates (sleeping pills or short-term pain-killers), rifampicin (tuberculosis), carbamazepine (epilepsy), diphenylhydantoin and phenytoin (seizures of the brain), primidone (anti-convulsant) or cyclosporin (organ transplant) may reduce the time that ORACEA stays active in your system.
Danish: Indtagelse af barbiturater (sovepiller eller korttidsvirkende smertelindrende medicin), rifampicin (mod tuberkulose), carbamazepin (mod epilepsi), diphenylhydantoin og phenytoin (anfald i hjernen), primidon (krampestillende) eller cyclosporin (i forbindelse med organtransplantation) kan reducere det tidsrum, hvor ORACEA forbliver aktivt i kroppen.
English: Using ORACEA with the general anaesthetic methoxyfluorane may cause serious harm to the kidneys.
Danish: Brug af ORACEA sammen med narkosemidlet methoxyfluoran kan give alvorlig skade på nyrerne.
English: Driving and using machines ORACEA has no or negligible influence on the ability to drive and use machines.
Danish: Trafik- og arbejdssikkerhed ORACEA påvirker ikke eller i ubetydelig grad evnen til at føre motorkøretøj eller betjene maskiner.
English: Solid dosage forms of the tetracyclines may cause oesophageal irritation and ulceration.
Danish: Doseringer af tetracykliner i fast form kan medføre irritation og ulceration i spiserøret.
English: ANNEX IV CONDITIONS OF THE MARKETING AUTHORISATION(S)
Danish: BILAG IV BETINGELSER FOR MARKEDSFØRINGSTILLADELSE
English: Uncommon: ≥ 1/1,000 to < 1/100 Rare:
Danish: Ikke almindelig: ≥ 1/1 000 til < 1/100 Sjælden:
English: Nausea, vomiting, diarrhoea, anorexia
Danish: Kvalme, opkastning, diare, anoreksi
English: Children and adolescents Doxycycline is contraindicated in children below age 12 (see section 4.3).
Danish: Doxycyclin er kontraindiceret til børn under 12 år (se pkt.
English: Very rare: Brown-black microscopic discolouration of thyroid tissue has been reported with long term use of tetracyclines.
Danish: Det endokrine system: Meget sjælden: Brun-sort mikroskopisk misfarvning af skjoldbruskkirtelvævet er blevet indberettet i forbindelse med langvarig brug af tetracykliner.
English: If you are taking blood thinners, your doctor may need to make changes to the dose of your blood thinner.
Danish: Hvis De tager blodfortyndende medicin, vil Deres læge muligvis være nødt til at ændre doseringen af Deres blodfortyndende medicin.
English: The absorption of doxycycline from the gastro-intestinal tract may be inhibited by bi- or tri-valent ions such as aluminium, zinc, calcium (found for example in milk, dairy products and calciumcontaining fruit juices), by magnesium (found for example in antacids) or by iron preparations, activated charcoal, cholestyramine, bismuth chelates and sucralfate.
Danish: Absorptionen af doxycyclin fra mave-tarmkanalen kan blive hæmmet af bi- eller trivalente ioner såsom aluminium, zink, kalcium (som blandt andet findes i mælk, mælkeprodukter og kalciumholdige frugtsafter), af magnesium (som findes i f.eks. anticider) eller af jernpræparater, aktivt kul, kolestyramin, bismuth-chelater og sukralfat.
English: Patients known to have, or suspected to have, achlorhydria or who have had surgery that bypasses or excludes the duodenum must not be prescribed doxycycline.
Danish: Patienter, der vides at have, eller som mistænkes at have, aklorhydri, eller patienter som har gennemgået kirurgi, der leder mavesækkens indhold uden om duodenum (gastrisk bypass eller eksklusion af duodenum), må ikke ordineres doxycyclin.
English: Opadry beige YS-1-17274-A (Hypromellose 3cP/6cP, Titanium dioxide, Macrogol 400, Yellow iron oxide, Red iron oxide, Polysorbate 80)
Danish: Opadry beige YS-1-17274-A (hypromellose 3cP/6cP, titaniumdioxid, makrogol 400, gul jernoxid, rød jernoxid, polysorbat 80)
English: Doxycycline can be used by breast-feeding mothers for short term use only.
Danish: Doxycyclin må kun anvendes i kort tid af ammende mødre.
English: Doxycycline has been shown to depress plasma prothrombin activity thereby potentiating the effect of anticoagulants of the dicoumarol type.
Danish: Doxycyclin har vist sig at hæmme plasmaprotrombinaktiviteten og derved forstærke virkningen af antikoagulanter af dicoumarol-typen.
English: DATE OF REVISION OF THE TEXT [To be completed nationally]
Danish: DATO FOR ÆNDRING AF TEKSTEN [Skal udfyldes nationalt]
English: Consequently, the CHMP required a commitment from the Applicant to perform an appropriate post-marketing study in order to further elucidate the risk for emergence of resistance in the intestinal and upper respiratory microflora associated with the longterm use of Oracea.
Danish: Som en konsekvens heraf krævede CHMP, at ansøgeren forpligtede sig til at udføre det foreslåede postmarketingsstudie for yderligere at belyse risikoen for fremkomst af resistens i mikrofloraen i tarmene og de øvre luftveje i forbindelse med langvarig brug af Oracea.
English: ORACEA must not be used during pregnancy since it may cause permanent discolouration of the teeth in the unborn child.
Danish: ORACEA må ikke anvendes under graviditet, da det kan medføre permanent misfarvning af tænderne hos det ufødte barn.
English: What ORACEA looks like and contents of the pack ORACEA is a modified-release hard capsule.
Danish: ORACEAS udseende og pakningsstørrelse ORACEA er en kapsel med modificeret udløsning.
English: Doxycycline has been shown to potentiate the hypoglycaemic effect of sulphonylurea oral antidiabetic agents.
Danish: Doxycyclin har vist sig at forstærke den hypoglykæmiske virkning af orale sulfonylurea-antidiabetika.
English: The CHMP considered that the safety of doxycycline (100-200 mg daily) has been established over many decades of clinical use, providing re-assurance on the tolerability of the lower dose of Oracea.
Danish: CHMP fandt, at doxycyclins sikkerhed (100-200 mg daglig) er fastlagt efter mange års klinisk brug, hvilket giver sikkerhed for, at Oraceas lavere dosis tolereres.
English: ORACEA should be administered with caution to patients with hepatic impairment or to those receiving potentially hepatotoxic medicinal products (see section 4.4)
Danish: ORACEA bør administreres med forsigtighed til patienter med nedsat leverfunktion eller til patienter, der får potentielt levertoksiske lægemidler (se pkt.
English: PHARMACEUTICAL FORM AND CONTENTS 56 modified-release hard capsules
Danish: LÆGEMIDDELFORM OG INDHOLDSMÆNGDE (PAKNINGSSTØRRELSE) 56 hårde kapsler med modificeret udløsning
English: Musculoskeletal, connective tissue and bone disorders: Very rare: Exacerbation of systemic lupus erythematosus
Danish: Knogler, led, muskler og bindevæv: Meget sjælden: Forværring af systemisk lupus erythematosus
English: NAME OF THE MARKETING AUTHORISATION HOLDER [See Annex I - To be completed nationally]
Danish: NAVN PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN [Se Bilag I - skal udfyldes nationalt]
English: INFORMATION IN BRAILLE [To be completed nationally]
Danish: INFORMATION I BRAILLE-SKRIFT [Skal udfyldes nationalt]
English: Skin and subcutaneous tissue disorders: Rare:
Danish: Levertoksicitet Hud og subkutane væv: Sjælden:
English: ≥ 1/10,000 to < 1/1,000
Danish: ≥ 1/10 000 til < 1/1 000
English: The Applicant should conduct a post-marketing microbiological study in order to further elucidate the risk for emergence of resistance in the intestinal and upper respiratory microflora associated with the long-term use of Oracea, and commit to submitting a study protocol within 3 months of approval.
Danish: Ansøgeren skal udføre en mikrobiologisk postmarketingsundersøgelse for yderligere at belyse risikoen for fremkomst af resistens blandt mikroflora i tarmene og de øvre luftveje i forbindelse med langvarig brug af Oracea og forpligte sig til indsende en undersøgelsesprotokol inden for 32 måneder efter godkendelsen.
English: Thrombocytopenia, neutropenia, eosinophilia Very rare: Haemolytic anaemia
Danish: Trombocytopeni, neutropeni, eosinofili Meget sjælden: Hæmolytisk anæmi
English: However, the studies submitted concerning the absence of risk for selection of antibiotic resistance in the normal microbiota were not considered as fully convincing, due to limitations in the methods used.
Danish: På grund af begrænsningerne i de anvendte metoder ansås de indsendte undersøgelser vedrørende fraværet af risiko for antibiotisk resistens i de normale mikroorganismer ikke for at være tilstrækkeligt overbevisende.
English: The half-life of doxycycline is not significantly altered in patients with severely impaired renal function.
Danish: Halveringstiden for doxycyclin ændres ikke signifikant hos patienter med svært nedsat nyrefunktion.
English: No dosage adjustment is necessary in patients with renal impairment.
Danish: Dosisjustering er ikke nødvendig hos patienter med nedsat nyrefunktion.
English: Concomitant use not recommended:
Danish: Samtidig brug der frarådes:
English: • Inflammation of the tongue
Danish: • Betændelse i tungen
English: Member State Marketing Authorisation Holder
Danish: Medlemsstat Indehaver af markedsføringstilladelsen
English: In a rat carcinogenicity study increases in benign tumours of the mammary gland (fibroadenoma), uterus (polyp) and thyroid (C-cell adenoma) were noted in females.
Danish: I et karcinogenicitetsstudie med rotter blev der hos hunrotter observeret en stigning i godartede tumorer i brystkirtlen (fibroadenom), uterus (polyp) og skjoldbruskkirtlen (C-celle-adenom).
English: The active substance is doxycycline.
Danish: - Aktivt stof: doxycyclin.
English: Triethyl citrate
Danish: Triethylcitrat
English: There is no information on the pharmacokinetics of doxycycline in patients with hepatic impairment.
Danish: Der er ingen information vedrørende doxycyclins farmakokinetik hos patienter med nedsat leverfunktion.
English: Blood and lymphatic system disorders: Rare:
Danish: Blod og lymfesystem: Sjælden:
English: - The CHMP considers that the benefits of marketing a systemic drug such as Oracea in the present indication outweigh the risk for potential harmful effects related to resistance development and therefore considers the benefit-risk ratio to be positive,
Danish: - CHMP finder, at fordelene ved at markedsføre et systemisk lægemiddel som Oracea med den aktuelle indikation opvejer risikoen for mulige, skadelige virkninger, der er forbundet med udviklingen af resistens, og finder benefit/risk-forholdet positivt,
English: Common: Frequency ≥ 1/100, < 1/10
Danish: Almindelig: Hyppighed ≥ 1/100 < 1/10
English: Maculopapular and erythematous rashes, skin photosensitivity, urticaria Very rare: Exfoliative dermatitis, angioneurotic oedema
Danish: Makulopapulært og erytematøst udslæt, lysoverfølsomhed af huden, urticaria Meget sjælden: Eksfoliativ dermatitis, angioneurotisk ødem
English: • Yeast infection around the anus or genitals
Danish: • Gærinfektion rundt om endetarmsåbningen eller kønsdelene
English: It is advisable that doxycycline and beta-lactam antibiotics should not therefore be used in combination.
Danish: Det frarådes derfor at anvende doxycyclin og betalaktamantibiotika i kombination.
English: Agents inhibiting peristalsis should not be employed in this situation.
Danish: I denne situation bør der ikke anvendes peristaltikhæmmende midler.
English: In addition, the preliminary results of a study comparing Oracea (40 mg doxycycline) to 100 mg doxycycline daily, both in conjunction with topical metronidazole, support the non-inferiority hypothesis of the Oracea dosing regimen.
Danish: De foreløbige undersøgelser, der sammenligner Oracea (40 mg doxycyclin) med 100 mg doxycyclin dagligt, begge samtidig med kutan behandling med metronidazol, underbygger hypotesen om, at Oraceas dosering ikke er underlegen.
English: Capsules: gelatin, black iron oxide, red iron oxide, yellow iron oxide, titanium dioxide
Danish: Kapslens skal Gelatine Jernoxid, sort Jernoxid, rød Jernoxid, gul Titaniumdioxid
English: The following side effects may occur very rarely (affects less than 1 user in 10,000) during treatment with the class of medicines to which ORACEA belongs (the tetracyclines):
Danish: Følgende bivirkninger kan optræde meget sjældent (påvirker færre end 1 ud af 10 000 brugere) under behandlingen med den type medicin, som ORACEA tilhører (tetracykliner):
English: MARKETING AUTHORISATION HOLDER [See Annex I - To be completed nationally] {Name and address} <{tel}> <{fax}> <{e-mail}>
Danish: Indehaveren af markedsføringstilladelsen og fremstiller [Se Bilag I - Skal udfyldes nationalt] {Navn og adresse} <{Tlf.}> <{Fax}> <{e-mail}>
English: ORACEA should not be used for long periods by breastfeeding mothers since it may cause tooth discolouration and reduced bone growth in the suckling child.
Danish: ORACEA bør ikke anvendes i længere perioder af ammende mødre, da det kan medføre misfarvning af tænderne og reducere knoglevæksten hos det ammende barn.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 40 mg doxycycline (as monohydrate).
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Hver kapsel indeholder 40 mg doxycyclin (som monohydrat).
English: Take special care with ORACEA
Danish: Vær ekstra forsigtig med at tage ORACEA
English: • Fungal infection
Danish: • Svampeinfektion
English: The following side effects may occur rarely (affects 1 to 10 users in 10,000) during treatment with the class of medicines to which ORACEA belongs (the tetracyclines):
Danish: Følgende bivirkninger kan optræde sjældent (påvirker 1 til 10 ud af 10 000 brugere) under behandlingen med den type medicin, som ORACEA tilhører (tetracykliner):
English: A decrease in fibula growth has been observed in premature infants given oral tetracycline in doses of 25 mg/kg every 6 hours.
Danish: Hos for tidligt fødte spædbørn, der er behandlet med orale tetracykliner i doser på 25 mg/kg hver 6. time, er der set en nedgang i væksthastigheden af fibula.
English: ORACEA is a medicine for use in adults to reduce the pimples or red bumps on the face caused by a condition called rosacea.
Danish: ORACEAS VIRKNING OG HVAD DE SKAL BRUGE DET TIL ORACEA er et lægemiddel til voksne, der anvendes til at reducere filipenser eller røde knopper i ansigtet, som er forårsaget af en hudsygdom, der hedder rosacea.
English: Doxycycline is not eliminated to any great extent during haemodialysis.
Danish: Doxycyclin elimineres ikke i særlig stor grad under hæmodialyse.
English: The table below lists adverse reactions on ORACEA in the pivotal clinical trials, ie adverse reactions for which the frequency on ORACEA was greater than the frequency on placebo (by ≥ 1%).
Danish: Tabellen nedenfor viser bivirkninger hos ORACEA-patienter i de pivotale, kliniske forsøg, dvs. bivirkninger, hvor hyppigheden i ORACEA-gruppen var højere end hyppigheden i placebo-gruppen (med ≥ 1 %).
English: Printing ink: shellac, propylene glycol, black iron oxide, indigo carmine aluminium lake, allura red AC aluminium lake, brilliant blue FCF aluminium lake, D & C yellow no. 10 aluminium lake, Opacode black S-1-8115, Opacode black S-1-8114.
Danish: Kapsler: gelatine, sort jernoxid, rød jernoxid, gul jernoxid, titaniumdioxid Trykblæk: shellak, propylenglykol, sort jernoxid, indigokarmin aluminium lake, allura rød AC aluminium lake, brilliant blue FCF aluminium lake, D & C gul nr. 10 aluminium lake, Opacode sort S1-8115, Opacode sort S-1-8114.
English: Each capsule contains 40 mg doxycycline (as monohydrate).
Danish: Hver kapsel indeholder 40 mg doxycyclin (som monohydrat).
English: Thus, the CHMP considers that the benefits of marketing a systemic drug such as Oracea in the present indication outweighs the risk for potential harmful effects related to resistance development and therefore consider the benefit-risk ratio to be positive.
Danish: CHMP fandt derfor, at fordelene ved at markedsføre et systemisk lægemiddel som Oracea med den aktuelle indikation opvejer risikoen for mulige, skadelige virkninger, der er forbundet med udviklingen af resistens, og finder at benefit/risk-forholdet er gunstigt.
English: ORACEA is indicated to reduce papulopustular lesions in adult patients with facial rosacea.
Danish: ORACEA er indiceret til reducering af papulopustulære læsioner hos voksne patienter med rosacea i ansigtet.
English: • Pain in the upper part of the abdomen
Danish: • Smerte i den øvre del af maven
English: Adverse reactionsa on ORACEA in pivotal placebo-controlled studies in rosacea: MedDRA system organ class
Danish: Bivirkningera hos ORACEA-gruppen i pivotale, placebokontrollerede studier hos patienter med rosacea:
English: What ORACEA contains
Danish: ORACEA indeholder:
English: Store in the original package in order to protect from light.
Danish: Opbevares i den originale emballage for at beskytte mod lys.
English: OTHER Store in the original package in order to protect from light.
Danish: ANDET Opbevares i den originale emballage for at beskytte mod lys.
English: Coadministration with a high-fat, high-protein meal that included dairy products reduced the bioavailability (AUC) of doxycycline from ORACEA by about 20% and reduced the peak plasma level by 43%.
Danish: reducerede biotilgængeligheden (AUC) af doxycyclin fra ORACEA med cirka 20 % og reducerede peak plasmaniveauet med 43 %.
English: Nervous system disorders: Rare:
Danish: Nervesystemet: Sjælden:
English: PACKAGE LEAFLET: INFORMATION FOR THE USER ORACEA 40 mg modified release hard capsules Doxycycline
Danish: INDLÆGSSEDDEL: INFORMATION TIL BRUGEREN ORACEA 40 mg hårde kapsler med modificeret udløsning Doxycyclin
English: You should take ORACEA with a full glass of water whilst sitting or standing to avoid any irritation to the throat.
Danish: De skal tage ORACEA sammen med et stort glas vand, mens De sidder ned eller står op.
English: • Sinus headache
Danish: • Sinus-hovedpine
English: Rosacea is a well-recognized chronic cutaneous disorder, often characterized by remissions and exacerbations, that primarily affects the face causing significant psychological problems in addition to the physical discomfort.
Danish: Rosacea er en velkendt kronisk hudsygdom, der ofte er karakteriseret af remissioner og forværringer.
English: ASAT increased Blood pressure increased Blood LDH increased Blood glucose increased a Defined as adverse events for which the frequency on ORACEA was higher than on placebo (by at least 1%)
Danish: Blodsukker forhøjet a Defineret som bivirkninger, hvis hyppighed med ORACEA var højere end med placebo (med mindst 1 %)
English: Very rare:
Danish: Hjerte: Sjælden:
English: • Inflammation of the skin causing flakiness
Danish: • Betændelse i huden, der medfører skeldannelse
English: According to several international guidelines, doxycycline is also commonly recommended for the treatment of rosacea but is only approved in a few EU countries; consequently the off-label use of doxycycline is widely prescribed in clinical practice for long-term treatment (months to up to several years) of acne vulgaris, with dosages generally higher (100 mg daily) than the proposed dosage for Oracea (40 mg daily).
Danish: Derfor bruges doxycyclin i klinikken ofte off-label til langvarig behandling (måneder op til flere år) af acne vulgaris i doser, der normalt er højere (100 mg om dagen) end den foreslåede dosis for Oracea (40 mg om dagen).
English: - The CHMP considers the efficacy of Oracea to reduce papulopustular lesions in adult patients with facial rosacea to be sufficiently demonstrated,
Danish: - CHMP finder, at Oraceas evne til at reducere papulopustuløse læsioner hos voksne patienter med rosacea i ansigtet, er tilstrækkeligt påvist,
English: Treatment should cease if evidence of raised intracranial pressure develops.
Danish: Meget sjælden: Udbulende fontanelle hos spædbørn Behandlingen bør ophøre, hvis der er tegn på udvikling af forhøjet intrakranielt tryk.
English: You should consider using a sunscreen or sunblock to reduce the risk of sunburn and you should stop using ORACEA
Danish: De bør overveje at bruge solcreme for at reducere risikoen for solforbrændinger.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each capsule contains 40 mg doxycycline (as monohydrate).
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver kapsel indeholder 40 mg doxycyclin (som monohydrat).
English: Immune system disorders: Rare:
Danish: Immunsystemet: Sjælden:
English: Invented name Strength Pharmaceutical Form
Danish: Styrke Lægemiddelform