FrancophonIA/ELRC3.0 huggingface dataset:
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND IMMEDIATE PACKAGING
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE OG DEN INDRE EMBALLAGE
English: Figures presented are cumulative percentages based upon a Kaplan Meier analysis including data collected after the addition of emtricitabine to open-label tenofovir disoproxil (KM-ITT).
Danish: g De viste tal er kumulative procentdele baseret på en Kaplan Meier-analyse, som inkluderer data indsamlet efter tillæg af emtricitabin til open-label tenofovir disoproxil (KM-ITT).
English: By intent to treat analysis (missing data and switch in antiretroviral therapy (ART) considered as failure), the proportion of patients with HIV-1 RNA below 400 copies/ml and 50 copies/ml at 48 weeks of treatment was 80% and 76% respectively in the tenofovir disoproxil 245 mg arm, compared to 84% and 80% in the stavudine arm. At 144 weeks, the proportion of patients with HIV-1 RNA below 400 copies/ml and 50 copies/ml was 71% and 68% respectively in the tenofovir disoproxil 245 mg arm, compared to 64% and 63% in the stavudine arm.
Danish: Ved behandlingsintentionsanalyse (manglende data og skift i antiretroviral behandling (ART) blev betragtet som svigt) var procentdelen af patienter med HIV 1-rna under 400 kopier/ml og 50 kopier/ml i uge 48 af behandlingen henholdsvis 80% og 76% i 245 mg tenofovir disoproxil behandlingsarmen, sammenlignet med 84% og 80% i stavudin behandlingsarmen.
English: The following side effects are rare (these can affect up to 1 in every 1,000 patients):
Danish: Følgende bivirkninger er sjældne (kan opstå hos op til 1 ud af 1.000 personer):
English: The length of combination antiretroviral therapy, corticosteroid use, alcohol consumption, severe immunosuppression, higher body mass index, among others, may be some of the many risk factors for developing this disease.
Danish: Til de mange risikofaktorer for udvikling af denne sygdom hører blandt andre: Varigheden af kombinationsbehandlingen, anvendelse af kortikosteroider, alkoholforbrug, alvorligt nedsat immunforsvar, samt (over-)vægt (højere Body Mass Index (BMI)).
English: Although the aetiology is considered to be multifactorial (including corticosteroid use, alcohol consumption, severe immunosuppression, higher body mass index), cases of osteonecrosis have been reported, particularly in patients with advanced HIV disease and/or long-term exposure to CART.
Danish: Ætiologien anses dog for at være multifaktoriel (omfattende anvendelse af kortikosteroider, alkoholforbrug, svær immunosuppression, højere Body Mass Index (BMI)).
English: Tenofovir disoproxil Mylan 245 mg film-coated tablets tenofovir disoproxil
Danish: Tenofovir disoproxil Mylan 245 mg filmovertrukne tabletter tenofovir disoproxil
English: Lumbar spine BMD at least 6% decrease b NA
Danish: Reduktion på mindst 6% i BMD for columna lumbalisb
English: Cases of acute renal failure after initiation of high dose or multiple non-steroidal anti-inflammatory drugs (NSAIDs) have been reported in patients treated with tenofovir disoproxil and with risk factors for renal dysfunction.
Danish: Hos patienter i behandling med tenofovir disoproxil med risikofaktorer for renal dysfunktion er der blevet rapporteret tilfælde af akut nyresvigt efter påbegyndelse af højdosisbehandling med nonsteroide antiinflammatoriske midler (NSAID'er) og behandling med flere NSAID'er.
English: Bone Mineral Density (BMD) data from Study GS-US-174-0115 are summarized in Table 8: Table 8: Bone Mineral Density Evaluation at Baseline, Week 72 and 192
Danish: Data for knoglemineraltæthed (BMD) fra studie GS-US-174-0115 er opsummeret i tabel 8:
English: Co-administration of tenofovir disoproxil and didanosine results in a 40-60% increase in systemic exposure to didanosine that may increase the risk of didanosine-related adverse reactions (see section 4.5).
Danish: Samtidig administration af af tenofovir disoproxil og didanosin resulterer i en 40-60% stigning i systemisk eksponering for didanosin, hvilket kan øge risikoen for didanosin-relaterede bivirkninger (se pkt.
English: The increased exposure of tenofovir could potentiate adverse reactions associated with tenofovir disoproxil, including renal disorders.
Danish: Den forøgede tenofovir-eksponering kan medføre forstærkede bivirkninger af tenofovir disoproxil, herunder nyrerelaterede bivirkninger.
English: Emtricitabine 200 mg/ tenofovir disoproxil 245 mg (n = 45)
Danish: 200 mg emtricitabin/ 245 mg tenofovir disoproxil (n = 45)
English: The adverse reactions observed in paediatric patients who received treatment with tenofovir disoproxil were consistent with those observed in clinical studies of tenofovir disoproxil in adults (see section 4.8 Tabulated summary of adverse reactions and 5.1).
Danish: De observerede bivirkninger hos pædiatriske patienter, der fik behandling med tenofovir disoproxil var overensstemmende med dem, der blev observeret i kliniske studier af tenofovir disoproxil hos voksne (se pkt.
English: angioedema Musculoskeletal and connective tissue disorders: Uncommon:
Danish: Knogler, led, muskler og bindevæv: Ikke almindelig:
English: Genotypic evaluations were performed on all patients within this group with HBV DNA > 400 copies/ml at week 96 (n = 17),
Danish: Der blev udført genotypestudier på alle patienter i denne gruppe med HBV-dna > 400 kopier/ml ved uge 96 (n = 17), uge 144 (n = 7) og uge 192 (n = 8).
English: This medicine is available in plastic bottles with a child resistant cap and wad containing 30 filmcoated tablets and in multipacks of 90 film-coated tablets comprising 3 bottles, each containing 30 film-coated tablets.
Danish: Fås i følgende pakningsstørrelser:30 filmovertrukne tabletter og multipakninger med 90 filmovertrukne tabletter (3 pakker af 30).
English: Then mix the powder with about 100 ml (half a glass) of water, orange juice or grape juice and drink immediately
Danish: Hvis De har særlige problemer med at synke, kan De knuse tabletten med spidsen af en ske og opløse den i ca. 100 ml (et halvt glas) vand, appelsinjuice eller druesaft.
English: Co-administration of tenofovir disoproxil and didanosine is not recommended as it results in a 4060% increase in systemic exposure to didanosine that may increase the risk of didanosine-related adverse reactions (see section 4.5).
Danish: Samtidig administration af tenofovir disoproxil og didanosin anbefales ikke, da det resulterer i en stigning i systemisk eksponering for didanosin på 40-60%, hvilket kan øge risikoen for didanosinrelaterede bivirkninger (se pkt.
English: Whole body mean (SD) BMD Z-score a
Danish: Gennemsnitlig (SD) BMD Zscore for hele kroppena
English: How to take Tenofovir disoproxil Mylan
Danish: Sådan skal De tage Tenofovir disoproxil Mylan
English: Administration of 245 mg tenofovir disoproxil every 48 hours can be used based on modelling of single-dose pharmacokinetic data in HIV negative and non-HBV infected subjects with varying degrees of renal impairment, including end-stage renal disease requiring haemodialysis, but has not been confirmed in clinical studies.
Danish: Dette er baseret på modellering af farmakokinetiske data for enkeltdosis hos HIV-negative patienter eller patienter uden HBV-infektion men med forskellige grader af nedsat nyrefunktion, herunder nyresygdom i slutstadiet, hvor det er nødvendigt med dialyse, og er ikke blevet bekræftet i kliniske studier.
English: For bottles: after first opening the bottle use within 90 days.
Danish: Til flasker: Skal anvendes inden for 90 dage efter første åbning.
English: Tenofovir disoproxil 245 mg n = 176
Danish: 245 mg tenofovir disoproxil n = 176
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING
Danish: OPLYSNINGER, DER SKAL ANFØRES PÅ YDEREMBALLAGEN
English: The following side effects are common (these can affect up to 10 in every 100 patients):
Danish: Følgende bivirkninger er meget almindelige (kan opstå hos mere end 10 ud af 100 personer):
English: e 48 weeks of double-blind tenofovir disoproxil followed by 96 weeks open-label.
Danish: e 48 uger dobbeltblind tenofovir disoproxil, efterfulgt af 96 uger open-label.
English: HBeAg loss/ seroconversion HBsAg loss/ seroconversion g g l l g g l l a
Danish: Tenofo vir disopro xiltenofovi r disopro xil
English: Tenofovir disoproxil Mylan 245 mg film-coated tablets
Danish: Tenofovir disoproxil Mylan 245 mg filmovertrukne tabletter
English: If you feel dizzy while taking Tenofovir disoproxil Mylan, do not drive or ride a bicycle and do not use any tools or machines.
Danish: Kør ikke bil eller motorcykel, lad være med at cykle og lad være med at arbejde med værktøj eller maskiner, hvis De bliver svimmel, når De tager Tenofovir disoproxil Mylan.
English: How to store Tenofovir disoproxil Mylan
Danish: Opbevaring af Tenofovir disoproxil Mylan
English: Co-administration of tenofovir disoproxil and didanosine is not recommended (see section 4.4).
Danish: Samtidig administration af tenofovir disoproxil og didanosin kan ikke anbefales (se pkt.
English: rhabdomyolysis
Danish: Lactosemonohydrat
English: The adverse reactions observed in adolescent patients who received treatment with tenofovir disoproxil were consistent with those observed in clinical studies of tenofovir disoproxil in adults (see section 4.8 Tabulated summary of adverse reactions and 5.1).
Danish: De observerede bivirkninger hos unge patienter, som blev behandlet med tenofovir disoproxil, svarede til de bivirkninger, der blev observeret i kliniske studier af tenofovir disoproxil hos voksne (se pkt.
English: 2, nephrogenic diabetes insipidus General disorders and administration site conditions: Very common:
Danish: Almene symptomer og reaktioner på administrationssstedet: Meget almindelig: asteni
English: Tenofovir disoproxil 245 mg (n = 45)
Danish: 245 mg tenofovir disoproxil (n = 45)
English: b 48 weeks of double-blind tenofovir disoproxil followed by 48 weeks open-label.
Danish: b 48 uger dobbeltblind tenofovir disoproxil, efterfulgt af 48 uger open-label.
English: dizziness
Danish: Overtræk
English: The safety of tenofovir disoproxil when used with ledipasvir/sofosbuvir and a pharmacokinetic enhancer (e.g. ritonavir or cobicistat) has not been established.
Danish: Sikkerheden af tenofovir disoproxil sammen med ledipasvir/sofosbuvir og en farmakokinetisk booster (f.eks. ritonavir eller cobicistat) er ikke klarlagt.
English: What Tenofovir disoproxil Mylan is and what it is used for What you need to know before you take Tenofovir disoproxil Mylan How to take Tenofovir disoproxil Mylan Possible side effects
Danish: Det skal De vide, før De begynder at tage Tenofovir disoproxil Mylan Sådan skal De tage Tenofovir disoproxil Mylan Bivirkninger
English: Voxilaprevir: AUC: ↑ 143% Cmax:↑ 72% Cmin: ↑ 300%
Danish: AUC: ↑ 143% Cmax:↑ 72% Cmin: ↑ 300%
English: p 48 weeks of double-blind adefovir dipivoxil followed by 336 weeks open-label tenofovir disoproxil.
Danish: p 48 uger dobbeltblind adefovirdipivoxil, efterfulgt af 336 uger open-label tenofovir disoproxil.
English: The following side effects are uncommon (these can affect up to 1 in every 100 patients):
Danish: Følgende bivirkninger er ikke almindelige (kan opstå hos op til 1 ud af 100 personer):
English: The increased exposure of tenofovir could potentiate tenofovirassociated adverse events, including renal disorders.
Danish: Den forøgede tenofovir-eksponering kan forstærke effekten af bivirkninger ved tenofovir, herunder nyresygdomme.
English: o 48 weeks of double-blind tenofovir disoproxil followed by 336 weeks open-label.
Danish: o 48 uger dobbeltblind tenofovir disoproxil, efterfulgt af 336 uger open-label.
English: osteomalacia (manifested as bone pain and infrequently contributing to fractures) , myopathy Renal and urinary disorders: Uncommon:
Danish: osteomalaci (manifesterer sig som knoglesmerter og i sjældne tilfælde medvirkende årsag til frakturer)
English: High density polyethylene (HDPE) bottle with polypropylene (PP) child resistant closure with wad containing aluminium induction sealing liner and desiccant (silica gel), available in the following pack sizes: 30 film-coated tablets and multipacks containing 90 (3 packs of 30) film-coated tablets.
Danish: Polyethylenflaske med høj densitet (HDPE) og børnesikret polypropylenlåg (PP) med aluminiumsinduktionsforsegling og tørremiddel (silicagel).
English: Adefovir dipivoxil 10 mg roll over to tenofovir disoproxil 245 mg n = 125
Danish: 10 mg adefovirdipivoxil skift til 245 mg tenofovir disoproxil n = 125
English: For dosage see section 3, How to take Tenofovir disoproxil Mylan.
Danish: 3, Sådan skal De tage Tenofovir disoproxil Mylan, for dosering.
English: In patients with severe renal impairment (creatinine clearance < 30 ml/min) and in patients who require haemodialysis use of tenofovir disoproxil is not recommended.
Danish: Det frarådes at bruge tenofovir disoproxil hos patienter med svært nedsat nyrefunktion (kreatininclearance < 30 ml/min), og hos patienter med behov for hæmodialyse.
English: g 48 weeks of double-blind tenofovir disoproxil followed by 144 weeks open-label.
Danish: g 48 uger dobbeltblind tenofovir disoproxil, efterfulgt af 144 uger open-label.
English: The safety of tenofovir disoproxil when used with sofosbuvir/velpatasvir and a pharmacokinetic enhancer (e.g. ritonavir or cobicistat) has not been established.
Danish: Sikkerheden af tenofovir disoproxil sammen med sofosbuvir/velpatasvir og en farmakokinetisk booster (f.eks. ritonavir eller cobicistat) er ikke klarlagt.
English: Tenofovir disoproxil 245 mg n = 250
Danish: 245 mg tenofovir disoproxil n = 250
English: f 48 weeks of double-blind adefovir dipivoxil followed by 96 weeks open-label tenofovir disoproxil.
Danish: f 48 uger dobbeltblind adefovirdipivoxil, efterfulgt af 96 uger open-label tenofovir disoproxil.
English: Adefovir dipivoxil 10 mg roll over to tenofovir disoproxil 245 mg n = 90
Danish: 10 mg adefovirdipivoxil skift til 245 mg tenofovir disoproxil n = 90
English: Tenofovir disoproxil Mylan 245 mg film-coated tablets are light blue, round, biconvex, debossed with ‘TN245' on one side and ‘M' on other side.
Danish: Tenofovir disoproxil Mylan 245 mg filmovertrukne tabletter er lyseblå, runde, bikonvekse, præget med „TN245“ på den ene side og „M“ på den anden Medicinen fås i plastikflasker med børnesikret hætte og forsegling med 30 filmovertrukne tabletter og som multipakninger med 90 filmovertrukne tabletter (3 flasker af 30 filmovertrukne tabletter).
English: • pain in the tummy (abdomen) caused by inflammation of the liver
Danish: • mavesmerter på grund af betændelse i leveren
English: Whole body mean (SD) change from baseline
Danish: Gennemsnitlig (SD) ændring i BMD Z-score for hele kroppen fra baselinea
English: • breakdown of muscle, muscle pain or weakness
Danish: • kvalme, opkastning og mavesmerter
English: c 48 weeks of double-blind adefovir dipivoxil followed by 48 weeks open-label tenofovir disoproxil.
Danish: c 48 uger dobbeltblind adefovirdipivoxil, efterfulgt af 48 uger open-label tenofovir disoproxil.
English: (log10 copies/ml) HBV DNA (%)
Danish: (log10 kopier/ml) HBV-dna (%) < 400 kopier/ml (< 69 IE/ml) ALAT (%) Normaliseret ALATd
English: rash
Danish: Batch
English: Lumbar spine mean (SD) change from baseline
Danish: Gennemsnitlig (SD) ændring i BMD Z-score for columna lumbalis fra baselinea
English: The population used for analysis of histology included only patients with available liver biopsy data (Missing = Excluded) by week 240.
Danish: Histologisk responsa,b a Populationen, som blev analyseret histologisk, inkluderede kun patienter med tilgængelige data fra leverbiopsi
English: + Emtricitabine/Tenofovir disoproxil (200 mg/245 mg q.d.)
Danish: + Emtricitabin/Tenofovir disoproxil (200 mg/245 mg q.d.)
English: l 48 weeks of double-blind tenofovir disoproxil followed by 240 weeks open-label.
Danish: l 48 uger dobbeltblind tenofovir disoproxil, efterfulgt af 240 uger open-label.
English: + Efavirenz/Emtricitabine/ Tenofovir disoproxil (600 mg/200 mg/245 mg q.d.)
Danish: + Efavirenz/emtricitabin/ Tenofovir disoproxil (600 mg/200 mg/245 mg q.d.)
English: + Emtricitabine/Rilpivirine/ Tenofovir disoproxil (200 mg/25 mg/245 mg q.d.)
Danish: + Emtricitabin/rilpivirin/ Tenofovir disoproxil (200 mg/25 mg/245 mg q.d.)
English: The safety of tenofovir disoproxil when used with sofosbuvir/velpatasvir/vox ilaprevir and a pharmacokinetic enhancer (e.g. ritonavir or cobicistat) has not been established.
Danish: Sikkerheden af tenofovirdisoproxil sammen med sofosbuvir/velpatasvir/voxila-previr og en farmakokinetisk booster (f.eks. ritonavir eller cobicistat) er ikke klarlagt.
English: 48 weeks of double-blind tenofovir disoproxil followed by 144 weeks open-label.
Danish: h 48 uger dobbeltblind tenofovir disoproxil, efterfulgt af 144 uger open-label.
English: h 48 weeks of double-blind adefovir dipivoxil followed by 144 weeks open-label tenofovir disoproxil.
Danish: h 48 uger dobbeltblind adefovirdipivoxil, efterfulgt af 144 uger open-label tenofovir disoproxil.
English: i 48 weeks of double-blind tenofovir disoproxil followed by 192 weeks open-label.
Danish: i 48 uger dobbeltblind tenofovir disoproxil, efterfulgt af 192 uger open-label.
English: Didanosine
Danish: angioødem
English: 48 weeks of double-blind tenofovir disoproxil followed by up to 192 weeks open-label.
Danish: c 48 uger dobbeltblind tenofovir disoproxil, efterfulgt af op til 192 uger open-label.
English: m 48 weeks of double-blind adefovir dipivoxil followed by 240 weeks open-label tenofovir disoproxil.
Danish: m 48 uger dobbeltblind adefovirdipivoxil, efterfulgt af 240 uger open-label tenofovir disoproxil.
English: 48 weeks of double-blind adefovir dipivoxil followed by up to 192 weeks open-label tenofovir disoproxil.
Danish: d 48 uger dobbeltblind adefovirdipivoxil, efterfulgt af op til 192 uger open-label tenofovir disoproxil.
English: As tenofovir disoproxil may cause renal damage monitoring of renal function is recommended (see sections 4.4 and 4.8 Summary of the safety profile).
Danish: Da tenofovir disoproxil kan foråsage nyreskader, anbefales monitorering af nyrefunktionen (se pkt.
English: Adult patients with creatinine clearance < 50 ml/min, including haemodialysis patients:
Danish: Voksne patienter med en kreatininclearance < 50 ml/min, herunder hæmodialysepatienter Der er begrænsede data om sikkerhed og virkning af tenofovir disoproxil hos patienter med nedsat nyrefunktion.
English: j 48 weeks of double-blind adefovir dipivoxil followed by 192 weeks open-label tenofovir disoproxil.
Danish: j 48 uger dobbeltblind adefovirdipivoxil, efterfulgt af 192 uger open-label tenofovir disoproxil.
English: 48 weeks of double-blind adefovir dipivoxil followed by 144 weeks open-label tenofovir disoproxil.
Danish: i 48 uger dobbeltblind adefovirdipivoxil, efterfulgt af 144 uger open-label tenofovir disoproxil.
English: • pain in the tummy (abdomen) caused by inflammation of the pancreas
Danish: • mavesmerter på grund af betændelse i bugspytkirtlen
English: 48 weeks of double-blind adefovir dipivoxil followed by 240 weeks open-label tenofovir disoproxil.
Danish: n 48 uger dobbeltblind adefovirdipivoxil, efterfulgt af 240 uger open-label tenofovir disoproxil.
English: 48 weeks of double-blind adefovir dipivoxil followed by 192 weeks open-label tenofovir disoproxil.
Danish: k 48 uger dobbeltblind adefovirdipivoxil, efterfulgt af 192 uger open-label tenofovir disoproxil.
English: 48 weeks of double-blind tenofovir disoproxil followed by 192 weeks open-label.
Danish: j 48 uger dobbeltblind tenofovir disoproxil, efterfulgt af 192 uger open-label.
English: In the tenofovir disoproxil treatment arm, 7% of patients discontinued treatment due to an adverse event; 9% of patients experienced a confirmed increase in serum creatinine of ≥ 0.5 mg/dl or confirmed serum phosphate of < 2 mg/dl through week 48; there were no statistically significant differences between the combined tenofovir-containing arms and the entecavir arm. After 168 weeks, 16% (7/45) of the tenofovir disoproxil group, 4% (2/45) of the emtricitabine plus tenofovir disoproxil group, and 14% (3/22) of the entecavir group experienced tolerability failure.
Danish: I behandlingsarmen med tenofovir disoproxil afbrød 7% af patienterne behandlingen på grund af en bivirkning, 9% af patienterne fik bekræftet forhøjelse i serumkreatinin på ≥ 0,5 mg/dl eller bekræftet serumphosphat på < 2 mg/dl til og med uge 48.
English: Increased plasma concentrations of tenofovir resulting from co-administration of tenofovir disoproxil, ledipasvir/sofosbuvir and darunavir/ritonavir may increase adverse reactions related to tenofovir disoproxil, including renal disorders.
Danish: Øget plasmakoncentration af tenofovir som følge af samtidig administration af tenofovir disoproxil, ledipasvir/sofosbuvir og darunavir/ritonavir kan øge risikoen for bivirkninger relaterede til tenofovir disoproxil, herunder nyrerelaterede bivirkninger.
English: Increased plasma concentrations of tenofovir resulting from co-administration of tenofovir disoproxil, ledipasvir/sofosbuvir and atazanavir/ritonavir may increase adverse reactions related to tenofovir disoproxil, including renal disorders.
Danish: Øget plasmakoncentration af tenofovir som følge af samtidig administration af tenofovir disoproxil, ledipasvir/sofosbuvir og atazanavir/ritonavir kan øge risikoen for bivirkninger relaterede til tenofovir disoproxil, herunder nyrerelaterede bivirkninger.
English: Increased plasma concentrations of tenofovir resulting from co-administration of tenofovir disoproxil, sofosbuvir/velpatasvir and darunavir/ritonavir may increase adverse reactions related to tenofovir disoproxil, including renal disorders.
Danish: Øget plasmakoncentration af tenofovir som følge af samtidig administration af tenofovir disoproxil, sofosbuvir/velpatasvir og darunavir/ritonavir kan øge risikoen for bivirkninger relaterede til tenofovir disoproxil, herunder nyrerelaterede bivirkninger.
English: Increased plasma concentrations of tenofovir resulting from co-administration of tenofovir disoproxil, sofosbuvir/velpatasvir and lopinavir/ritonavir may increase adverse reactions related to tenofovir disoproxil, including renal disorders.
Danish: Øget plasmakoncentration af tenofovir som følge af samtidig administration af tenofovirdisoproxil, sofosbuvir/velpatasvir og lopinavir/ritonavir kan øge risikoen for bivirkninger relaterede til tenofovir disoproxil, herunder nyrerelaterede bivirkninger.
English: Increased plasma concentrations of tenofovir resulting from coadministration of tenofovir disoproxil, sofosbuvir/velpatasvir/vox ilaprevir and darunavir/ritonavir may increase adverse reactions related to tenofovir disoproxil, including renal disorders.
Danish: Øget plasmakoncentration af tenofovir som følge af samtidig administration af tenofovirdisoproxil, sofosbuvir/velpatasvir/voxila-previr og darunavir/ritonavir kan øge risikoen for bivirkninger relateret til tenofovirdisoproxil, herunder nyrerelaterede bivirkninger.
English: Tenofovir: AUC: ↔ Cmax: ↑ 42% Cmin: ↔
Danish: AUC: ↔ Cmax: ↑ 42% Cmin: ↔
English: Bulgaria дотарем
Danish: Bulgarien дотарем
English: Nationally authorised medicinal products Member state
Danish: Bilag I Fortegnelse over nationalt godkendte lægemidler
English: A. Martins & Fernandes, S.A.
Danish: A. Martins & Fernandes, S.A. Dotarem
English: Netherlands Guerbet Nederland Bv
Danish: Guerbet Nederland BV
English: Intraarticular use
Danish: intraartikulær anvendelse
English: Belgium Ge Healthcare Bvba
Danish: GE Healthcare Bvba
English: Ge Healthcare Buchler Gmbh & Co. Kg
Danish: GE Healthcare Buchler GmbH & Co.
English: Belgium Bayer Sa Nv
Danish: Bayer SA NV
English: Sanochemia Pharmazeutika Ag Gadotersäure Sanochemia
Danish: Sanochemia Pharmazeutika AG
English: Jenapharm Gmbh & Co Kg
Danish: Jenapharm GmbH & Co Kg Dotagraf
English: Mallinckrodt Deutschland Gmbh Optimark
Danish: Mallinckrodt Deutschland GmbH
English: Ge Healthcare Handels Gmbh
Danish: GE Healthcare Handels GmbH Omniscan
English: Netherlands Bayer Bv
Danish: Bayer BV
English: Solution for injection Intraarticular use
Danish: Storbritannien injektionsvæske intravenøs anvendelse
English: Solution for injection/infusion
Danish: injektions/infusionsvæske, opløsning
English: Netherlands Ge Healthcare B.V.
Danish: GE Healthcare B.V.
English: Sanochemia Pharmazeutika Ag Cyclolux Rep
Danish: Cyclolux Rep