natgillin/translations-raw huggingface dataset:
Rapamune blev vurderet i et kontrolleret klinisk forsøg af 36 måneders varighed, hvor der var inkluderet nyretransplanterede patienter i alderen under 18 år, som ansås for at have en høj immunologisk risiko, defineret som havende én eller flere akutte episoder med allograftafstødning i anamnesen og/ eller med tilstedeværelsen af kronisk allograftnefropati bekræftet ved nyrebiopsi.
Rapamune was assessed in a 36-month controlled clinical trial enrolling renal transplant patients  18 years of age considered at high-immunologic risk, defined as having a history of one or more acute allograft rejection episodes and/ or the presence of chronic allograft nephropathy on a renal biopsy.
Mange af de generelle farmakokinetiske oplysninger blev fremskaffet ved brug af den orale opløsning, hvilket resumeres først.
Much of the general pharmacokinetic information was obtained using the oral solution, which is summarised first.
Oplysninger, der er direkte relateret til tabletformuleringen, resumeres specifikt i afsnittet Oral tablet.
Information directly related to the tablet formulation is summarised specifically in the Oral Tablet section.
Oral opløsning Efter indgivelse af oral opløsning absorberes sirolimus hurtigt med en peak koncentration efter 1 time hos sunde individer, der har fået en enkelt dosis, og 2 timer hos patienter med stabile nyretransplantater, der har fået flere doser.
Oral solution Following administration of the oral solution, sirolimus is rapidly absorbed, with a time to peak concentration of 1 hour in healthy subjects receiving single doses and 2 hours in patients with stable renal allografts receiving multiple doses.
14%.
The systemic availability of sirolimus in combination with simultaneously administered ciclosporin (Sandimune) is approximately 14%.
3 gange.
Upon repeated administration, the average blood concentration of sirolimus is increased approximately 3-fold.
Eliminationshalveringstiden hos stabile nyretransplanterede patienter efter indgift af mange orale doser var 62 ± 16h.
The terminal half-life in stable renal transplant patients after multiple oral doses was 62  16 h.
Data over laveste sirolimus blodkoncentrationer hos 35 nyretransplanterede patienter > 65 år var de samme som hos en voksenpopulation (n = 822) i alderen 18 til 65 år.
Sirolimus trough concentration data in 35 renal transplant patients > 65 years of age were similar to those in the adult population (n = 822) from 18 to 65 years of age.
28 yngre pædiatriske patienter (580 ml/ h/ kg) end hos ældre pædiatriske patienter (450 ml/ h/ kg) sammenlignet med voksne (287 ml/ h/ kg).
In paediatric patients on dialysis (30% to 50% reduction in glomerular filtration rate) within age ranges of 5 to 11 years and 12 to 18 years, the mean weight-normalised CL/ F was larger for younger paediatric patients (580 ml/ h/ kg) than for older paediatric patients (450 ml/ h/ kg) as compared with adults (287 ml/ h/ kg).
Hos patienter med svært nedsat hepatisk funktion (Child - Pugh klassifikation C) var middelværdierne for sirolimus AUC og t½ øget med henholdsvis 210% og 170%, og CL/ F var nedsat med 67% sammenlignet med normale sunde individer.
In severe hepatically impaired patients (Child-Pugh classification C), mean values for sirolimus AUC and t1/ 2 were increased 210% and 170% respectively, and CL/ F was decreased by 67% compared to normal healthy subjects.
Oral tablet Hos sunde frivillige personer er biotilgængeligheden af sirolimus efter en enkelt dosis af tabletformuleringen omkring 27% højere i forhold til den orale opløsning.
30 Oral Tablet In healthy subjects, the mean extent of bioavailability of sirolimus after single-dose administration of the tablet formulation is about 27% higher relative to the oral solution.
Gennemsnitligt Cmax faldt med 35% og gennemsnitligt tmax steg med 82%.
The mean Cmax was decreased by 35% and mean tmax increased by 82%.
Forskellen i biotilgængeligheden var mindre tydelig ved steady- state indgivelse til nyretransplanterede patienter, og terapeutisk ækvivalens er påvist i en randomiseret undersøgelse af 477 patienter.
The difference in bioavailability was less marked upon steady-state administration to renal transplant recipients, and therapeutic equivalence has been demonstrated in randomised study of 477 patients.
Ved skift af patienter fra oral opløsning til tabletformulering anbefales det at give samme dosis og verificere laveste sirolimus koncentration 1 til 2 uger efter, for at sikre at koncentrationen er inden for de anbefalede målområder.
When switching patients between oral solution and tablet formulations, it is recommended to give the same dose and to verify the sirolimus trough concentration 1 to 2 weeks later to assure that it remains within recommended target ranges.
Ved skift mellem forskellige tabletstyrker anbefales også kontrol af laveste koncentrationer.
Also when switching between different tablet strengths, verification of trough concentrations is recommended.
Hos 24 sunde frivillige personer, som fik Rapamune tabletter og et måltid med højt fedtindhold, viste Cmax, tmax og AUC stigninger på henholdsvis 65%, 32% og 23%.
In 24 healthy volunteers receiving Rapamune tablets with a high-fat meal, Cmax, tmax and AUC showed increases of 65%, 32%, and 23%, respectively.
Grapefrugtjuice påvirker den CYP3A4 - formidlede metabolisme og skal derfor undgås.
Grapefruit juice affects CYP3A4-mediated metabolism and must, therefore, be avoided.
Koncentrationerne af sirolimus efter indgivelse af Rapamune tabletter (5 mg) som enkeltdosis til sunde personer er dosisproportional mellem 5 og 40 mg.
Sirolimus concentrations, following the administration of Rapamune tablets (5 mg) to healthy subjects as single doses are dose proportional between 5 and 40 mg.
Initial behandling (2 til 3 måneder efter transplantationen):
Initial Therapy (2 to 3 months post-transplant):
Hos de fleste patienter, som fik Rapamune tabletter i en indledende dosis på 6 mg efterfulgt af en initial vedligeholdelsesdosis på 2 mg, nåede laveste sirolimus helblodkoncentrationer hurtigt steady- state koncentrationer inden for det anbefalede målområde (4 til 12 ng/ ml, kromatografisk analyse).
In most patients receiving Rapamune tablets with a loading dose of 6 mg followed by an initial maintenance dose of 2 mg, whole blood sirolimus trough concentrations rapidly achieved steady-state concentrations within the recommended target range (4 to 12 ng/ ml, chromatographic assay).
De farmakokinetiske parametre for sirolimus efter daglige doser på 2 mg Rapamune tabletter indgivet samtidig med cyclosporin microemulsion (4 timer før Rapamune tabletter) og kortikosteroider hos 13 nyretransplanterede patienter, baseret på data samlet ind 1 og 3 måneder efter transplantationen, var:
Sirolimus pharmacokinetic parameters following daily doses of 2 mg Rapamune tablets administered in combination with ciclosporin microemulsion (4 hours prior to Rapamune tablets) and corticosteroids in 13 renal transplant patients, based on data collected at months 1 and 3 after transplantation, were:
Cmin, ss, 7, 39 ± 2, 18 ng/ ml; Cmax, ss, 15, 0 ± 4, 9 ng/ ml; tmax, ss, 3, 46 ± 2, 40 h; AUCτ, ss, 230 ± 67 ng• h/ ml; CL/ F/ WT, 139 ± 63 ml/ h/ kg (parametre beregnet ud fra LC- MS/ MS prøveresultater).
Cmin, ss, 7.39  2.18 ng/ ml; Cmax, ss, 15.0  4.9 ng/ ml; tmax, ss, 3.46  2.40 h; AUC, ss, 230  67 ng h/ ml; CL/ F/ WT, 139  63 ml/ h/ kg (parameters calculated from LC-MS/ MS assay results).
De tilsvarende resultater for den orale opløsning i samme kliniske undersøgelse var Cmin, ss, 5, 40 ± 2, 50 ng/ ml; Cmax, ss, 14, 4 ± 5, 3 ng/ ml; tmax, ss, 2, 12 ± 0, 84 h; AUCτ, ss, 194 ± 78 ng• h/ ml; CL/ F/ WT, 173 ± 50 ml/ h/ kg.
The corresponding results for the oral solution in the same clinical trial were Cmin, ss 5.40  2.50 ng/ ml, Cmax, ss 14.4  5.3 ng/ ml, tmax, ss 2.12  0.84 h, AUC, ss 194  78 ng h/ ml, CL/ F/ W 173  50 ml/ h/ kg.
Laveste helblodkoncentrationer af sirolimus målt ved LC- MS/ MS var signifikant korreleret (r2 = 0, 85) til AUCτ, ss.
Whole blood trough sirolimus concentrations, as measured by LC/ MS/ MS, were significantly correlated (r2 = 0.85) with AUC , ss.
Baseret på monitorering af alle patienter, i perioden med samtidig behandling med cyclosporin, var gennemsnit af laveste koncentrationer (10., 90. percentil) (udtrykt ved kromatografiske prøveværdier)
Based on monitoring in all patients during the period of concomitant therapy with ciclosporin, mean (10th, 90th percentiles) troughs (expressed as chromatographic assay values) and daily doses were 8.6  3.0 ng/ ml (5.0 to 13 ng/ ml) and 2.1  0.70 mg (1.5 to 2.7 mg), respectively (see section 4.2).
Fra måned 3 til måned 12, efter ophør med cyclosporin, var gennemsnit af laveste koncentrationer (10., 90. percentil) (udtrykt ved kromatografiske prøveværdier) og daglige doser henholdsvis 19 ± 4, 1 ng/ ml (14 til 24 ng/ ml) og 8, 2 ± 4, 2 mg (3, 6 til 13, 6 mg) (se pkt.
From month 3 to month 12, following discontinuation of ciclosporin, mean (10th, 90th percentiles) troughs (expressed as chromatographic assay values) and daily doses were 19  4.1 ng/ ml (14 to 24 ng/ mL) and 8.2  4.2 mg (3.6 to 13.6 mg), respectively (see section 4.2).
4 gange så høj for at tage højde for både den manglende farmakokinetiske interaktion med cyclosporin (dobbelt stigning) og det forøgede immunosuppressive behov i mangel af cyclosporin (dobbelt stigning).
Therefore, the sirolimus dose was approximately 4-fold higher to account for both the absence of the pharmacokinetic interaction with ciclosporin (2-fold increase) and the augmented immunosuppressive requirement in the absence of ciclosporin (2-fold increase).
Carcinogenicitetsundersøgelser udført på mus og rotter viste øget incidens af lymfomer (han - og hunmus), hepatocellulært adenom og carcinom (hanmus) og granulocytisk leukæmi (hunmus).
31 Carcinogenicity studies conducted in mouse and rat showed increased incidences of lymphomas (male and female mouse), hepatocellular adenoma and carcinoma (male mouse) and granulocytic leukaemia (female mouse).
4. 6).
(see section 4.6).
Lactosemonohydrat macrogol magnesiumstearat talkum
Lactose monohydrate Macrogol Magnesium stearate Talc.
Macrogol glyceryl monooleat farmaceutisk glasur vandfri kalciumsulfat mikrokrystallinsk cellulose saccharose titanium dioxid poloxamer 188 α- tocopherol povidon
Macrogol Glyceryl monooleate Pharmaceutical glaze Anhydrous calcium sulphate Microcrystalline cellulose Sucrose Titanium dioxide Poloxamer 188  -tocopherol Povidone Carnauba wax:
30 karnaubavoks: rød opacode S- 1- 15095 (shellak glasur ~45% i ethanol, rød jernoxid (E172), isopropylalkohol, n- butyl alcohol, propylenglycol, ammoniumhydroxid, simethicon).
Red opacode S-1-15095 (shellac glaze ~45% in ethanol, red iron oxide (E172), isopropyl alcohol, n-butyl alcohol, propylene glycol, ammonium hydroxide, simethicone).
6. 5 Emballagetype og pakningsstørrelser
32 6.5 Nature and contents of container
Klar polyvinylklorid (PVC) / polyethylen (PE) / polychlorotrifluoethylen (Aclar) aluminium blisterpakninger på 30 og 100 tabletter.
Clear polyvinyl chloride (PVC)/ polyethylene (PE)/ polychlorotrifluoroethylene (Aclar) aluminium blister packages of 30 and 100 tablets.
EU/ 01/ 171/ 007- 8
EU/ 1/ 01/ 171/ 007-8
Hver tablet indeholder 2 mg sirolimus.
Each tablet contains 2 mg sirolimus.
Gul- beige, trekantformede overtrukne tabletter mærket “ RAPAMUNE 2 mg ” på den ene side.
Yellow to beige coloured, triangular-shaped coated tablet marked “ RAPAMUNE 2 mg ” on one side.
32 Anvendelse til sorte patienter:
Use in black recipients:
Anvendelse til børn og unge (< 18 år):
Use in children and adolescents (< 18 years):
Cyclosporin hæmmer metaboliseringen af sirolimus, og følgelig vil sirolimusniveauerne falde ved ophør med cyclosporin, med mindre dosis af sirolimis øges.
35 consequently, sirolimus levels will decrease when ciclosporin is discontinued unless the sirolimus dose is increased.
33 dosis = nuværende dosis x (mål for koncentration/ nuværende koncentration).
If further dose adjustment(s) are required during maintenance therapy (after discontinuation of ciclosporin), in most patients these adjustments can be based on simple proportion: new Rapamune dose = current dose x (target concentration/ current concentration).
De anbefalede laveste 24- timers koncentrationsintervaller for sirolimus er baseret på kromatografiske metoder.
The recommended ranges 24-hour trough concentration for sirolimus are based on chromatographic methods.
De koncentrationer der opnås ved disse forskellige metodologier er ikke enstydige.
All sirolimus concentrations reported in this Summary of Product Characteristics were either measured using chromatographic methods or have been converted to chromatographic method equivalents.
Justeringer af målområdet bør foretages i henhold til den anvendte prøvemetode til bestemmelse af sirolimuskoncentrationen.
Adjustments to the targeted range should be made according to the assay being utilised to determine the sirolimus trough concentrations.
Hos patienter med nedsat hepatisk funktion anbefales det, at sirolimusniveauerne i helblod monitoreres omhyggeligt.
36 In hepatically impaired patients, it is recommended that sirolimus whole blood trough levels be closely monitored.
Forebyggelse af cytomegalovirus (CMV) anbefales i 3 måneder efter transplantationen, specielt til patienter med forhøjet risiko for CMV sygdom.
37 Cytomegalovirus (CMV) prophylaxis is recommended for 3 months after transplantation, particularly for patients at increased risk for CMV disease.
Rapamune påbegyndes.
The risk/ benefit should be considered in patients with established hyperlipidemia before initiating an immunosuppressive regimen including Rapamune.
35 rhabdomyolyse eller andre bivirkninger, som er beskrevet i de respektive produktresuméer for disse stoffer.
During Rapamune therapy, patients administered an HMG-CoA reductase inhibitor and/ or fibrate, should be monitored for the possible development of rhabdomyolysis and other adverse effects as described in the respective Summary of Product Characteristics of these agents.
CYP3A4 hæmmere (som f. eks. ketoconazol, voriconazol, itraconazol, telithromycin eller clarithromycin) nedsætter metaboliseringen af sirolimus og øger sirolimus niveauerne.
38 telithromycin, or clarithromycin) decrease the metabolism of sirolimus and increase sirolimus levels.
Rifampicin øgede
Administration of multiple doses of rifampicin decreased sirolimus whole blood concentrations following a single 10 mg dose of Rapamune oral solution.
Moderate og svage CYP3A4 hæmmere kan nedsætte metaboliseringen af sirolimus og øge sirolimusniveauet (f. eks. kalcium- blokkere: verapamil; antisvampemidler: clotrimazol, fluconazol; antibiotika: troleandomycin; andre stoffer: bromocriptin, cimetidin, danazol, protease- hæmmere).
39 the results cannot exclude the possibility of changes in the pharmacokinetics that might affect the efficacy of the oral contraceptive during long term treatment with Rapamune.
37 Ingen klinisk signifikant, farmakokinetisk interaktion blev observeret mellem sirolimus og nogen af følgende stoffer: acyclovir, atorvastatin, digoxin, glibenclamid, methylprednisolon, nifedipin, prednisolon og trimethoprim/ sulphamethoxazol.
No clinically significant pharmacokinetic interaction was observed between sirolimus and any of the following substances: acyclovir, atorvastatin, digoxin, glibenclamide, methylprednisolone, nifedipine, prednisolone, and trimethoprim/ sulphamethoxazole.
De hyppigst rapporterede bivirkninger (forekommer hos > 10% af patienterne) er trombocytopeni, anæmi, pyreksi, hypertension, hypokaliæmi, hypofosfatæmi, urinvejsinfektion, hyperkolesterolæmi, hyperglykæmi, hypertriglyceridæmi, abdominalsmerter, lymfocele, perifert ødem, artralgi, akne, diarré, smerte, forstoppelse, kvalme, hovedpine, øget kreatinin i blodet og øget laktatdehydrogenase (LDH).
The most commonly reported adverse drug reactions (occurring in > 10% of patients) are thrombocytopenia, anaemia, pyrexia, hypertension, hypokalaemia, hypophosphataemia, urinary tract infection, hypercholesterolaemia, hyperglycaemia, hypertriglyceridaemia, abdominal pain, lymphocoele, peripheral oedema, arthralgia, acne, diarrhoea, pain, constipation, nausea, headache, increased blood creatinine, and increased blood lactate dehydrogenase (LDH).
I nedenstående tabel angives de bivirkninger, der er baseret på erfaringer fra kliniske forsøg og erfaringer fra perioden efter markedsføringen, efter organklasse og hyppighed.
40 Adverse reactions based on experience from clinical trials and postmarketing experience are presented in the following table by system organ class and frequency of occurrence.
Sepsis Lungebetændelse Pyelonephritis Herpes simplex Svampe -, virale og bakterielle infektioner (som f. eks. mycobakterielle infektioner, herunder
Sepsis Pneumonia Pyelonephritis Herpes simplex Fungal, viral, and bacterial infections (such as mycobacterial infections, including tuberculosis, Epstein-Barr virus, CMV, and Herpes zoster)
Metabolisme ernæring
41 System Organ Class
Unormale leverfunktions - prøver 39
Liver function tests abnormal
Hos patienter behandlet med immunsuppressiva, herunder Rapamune, er der rapporteret tilfælde af både BK- virus associeret nephropati og JC- virus associeret progressiv multifokal leukoencefalopati (PML).
42 Cases of BK virus associated nephropathy, as well as cases of JC virus associated progressive multifocal leukoencephalopathy (PML), have been reported in patients treated with immunosuppressants, including Rapamune.
Risikoen kan øges, når det laveste sirolimusniveau stiger.
Hepatotoxicity has been reported, the risk may increase as the trough sirolimus level increases.
40 Der er ikke udført kontrollerede kliniske forsøg med børn og unge (< 18 år) med dosering svarende til den nuværende indicerede for brugen af Rapamune til voksne - d. v. s. brug i kombination med cyclosporin og kortikosteroider i 2 til 3 måneder efter transplantationen, hvorefter cyclosporin fjernes.
Paediatric population Controlled clinical trials with posology comparable to that currently indicated for the use of Rapamune in adults — that is, use in combination with ciclosporin and corticosteroids for 2 to 3 months post-transplantation followed by withdrawal of ciclosporin thereafter— have not been conducted in children or adolescents ( 18 years of age).
Af de 89 patienter, der var konstateret EBV- seronegative inden transplantationen, udviklede 13 (15, 6%) PTLD.
43 Among 89 patients known to be EBV seronegative prior to transplantation, 13 (15.6%) were reported to have developed PTLD.
Patienter med lav til moderat immunologisk risiko blev undersøgt i cyclosporin elimination- Rapamune fase 3 vedligeholdelsesstudiet, som omfattede patienter, der fik en nyre transplanteret fra en afdød
Clinical Trials Patients at low to moderate immunological risk were studied in the phase 3 ciclosporin elimination-Rapamune maintenance trial, which included patients receiving a renal allograft from a cadaveric or living donor.
I to kliniske multicenterforsøg havde de novo nyretransplanterede patienter, som blev behandlet med Rapamune, mycophenolat mofetil, kortikosteroider og en IL- 2- receptorantagonist, en signifikant højere akut rejektionsfrekvens og en numerisk højere dødsfrekvens end de patienter, som blev
In two multi-centre clinical studies, de novo renal transplant patients treated with Rapamune, mycophenolate mofetil (MMF), corticosteroids, and an IL-2 receptor antagonist had significantly higher acute rejection rates and numerically higher death rates compared to patients treated with a calcineurin inhibitor, MMF, corticosteroids, and an IL-2 receptor antagonist (see section 4.4).
Mange af de generelle farmakokinetiske oplysninger blev fremskaffet ved brug af den orale opløsning, hvilket resumeres først.
45 Much of the general pharmacokinetic information was obtained using the oral solution, which is summarised first.
Hos pædiatriske patienter i dialyse (fald på 30% til 50% i det glomerulære filtreringsforhold) inden for aldersgruppen 5 til 11 år og 12 til 18 år var den gennemsnitlige vægtnormaliserede CL/ F større hos yngre pædiatriske patienter (580 ml/ h/ kg) end hos ældre pædiatriske patienter (450 ml/ h/ kg) sammenlignet med voksne (287 ml/ h/ kg).
In paediatric patients on dialysis (30% to 50% reduction in glomerular filtration rate) within age ranges of 5 to 11 years and 12 to 18 years, the mean weight-normalised CL/ F was larger for younger paediatric patients (580 ml/ h/ kg) than for older paediatric patients (450 ml/ h/ kg) as compared with adults (287 ml/ h/ kg).
43 Koncentrationerne af sirolimus blev målt i koncentrationskontrollerede forsøg hos pædiatriske nyretransplanterede patienter, der også fik cyclosporin og kortikosteroider.
Sirolimus concentrations were measured in concentration-controlled trials of paediatric renal-transplant patients who were also receiving ciclosporin and corticosteroids.
Oral tablet Hos sunde frivillige personer er biotilgængeligheden af sirolimus efter en enkelt dosis af tabletformuleringen omkring 27% højere i forhold til den orale opløsning.
46 Oral Tablet In healthy subjects, the mean extent of bioavailability of sirolimus after single-dose administration of the tablet formulation is about 27% higher relative to the oral solution.
4. 2).
Based on monitoring in all patients during the period of concomitant therapy with ciclosporin, mean (10th, 90th percentiles) troughs (expressed as chromatographic assay values) and daily doses were 8.6  3.0 ng/ ml (5.0 to 13 ng/ ml) and 2.1  0.70 mg (1.5 to 2.7 mg), respectively (see section 4.2).
44 Vedligeholdelsesbehandling:
Maintenance therapy:
Fra måned 3 til måned 12, efter ophør med cyclosporin, var gennemsnit af laveste koncentrationer (10., 90. percentil) (udtrykt ved kromatografiske prøveværdier) og daglige doser henholdsvis 19 ± 4, 1 ng/ ml (14 til 24 ng/ ml) og 8, 2 ± 4, 2 mg (3, 6 til 13, 6 mg) (se pkt.
From month 3 to month 12, following discontinuation of ciclosporin, mean (10th, 90th percentiles) troughs (expressed as chromatographic assay values) and daily doses were 19  4.1 ng/ ml (14 to 24 ng/ ml) and 8.2  4.2 mg (3.6 to 13.6 mg), respectively (see section 4.2).
Sirolimus var ikke mutagent i in vitro bakteriel omvendt mutationsbestemmelse, kromosomafvigelsesbestemmelse i en kinesisk hamsters ovariecelle, fremadrettet mutationsbestemmelse i muselymfecelle eller in vivo mikronuklear bestemmelse i mus.
Sirolimus was not mutagenic in the in vitro bacterial reverse mutation assays, the Chinese hamster ovary cell chromosomal aberration assay, the mouse lymphoma cell forward mutation assay, or the in vivo mouse micronucleus assay.
Carcinogenicitetsundersøgelser udført på mus og rotter viste øget incidens af lymfomer (han - og hunmus), hepatocellulært adenom og carcinom (hanmus) og granulocytisk leukæmi (hunmus).
47 Carcinogenicity studies conducted in mouse and rat showed increased incidences of lymphomas (male and female mouse), hepatocellular adenoma and carcinoma (male mouse) and granulocytic leukaemia (female mouse).
Macrogol glyceryl monooleat farmaceutisk glasur vandfri kalciumsulfat mikrokrystallinsk cellulose saccharose titanium dioxid brun jernoxid (E172) gul jernoxid (E172) poloxamer 188 α- tocopherol povidon karnaubavoks:
Macrogol Glyceryl monooleate Pharmaceutical glaze Anhydrous calcium sulphate Microcrystalline cellulose Sucrose Titanium dioxide Brown iron oxide (E172) Yellow iron oxide (E172) Poloxamer 188  -tocopherol Povidone Carnauba wax Red opacode S-1-15095 (shellac glaze ~45% in ethanol, red iron oxide (E172), isopropyl alcohol, n-butyl alcohol, propylene glycol, ammonium hydroxide, simethicone).
23 måneder.
23 months.
Må ikke opbevares ved temperaturer over 25° C.
Do not store above 25ºC.
6. 5 Emballagetype og pakningsstørrelser
48 6.5 Nature and contents of container
Ikke anvendte lægemidler samt affald heraf bør destrueres i henhold til lokale retningslinjer.
Any unused product or waste material would be disposed of in accordance with local requirements.
EU/ 01/ 171/ 009- 10
EU/ 1/ 01/ 171/ 009-10