natgillin/translations-raw huggingface dataset:
Kombinationsbehandling med antiretrovirale lægemidler er hos patienter med HIV associeret med omfordeling af kropsfedt (lipodystrofi), herunder tab af subkutant fedt perifert og i ansigtet, øget intraabdominalt og visceralt fedt, brysthypertrofi og dorsocervical fedtakkumulering (tyrenakke).
Lipodystrophy and metabolic abnormalities: combination antiretroviral therapy has been associated with redistribution of body fat (lipodystrophy) in HIV patients including the loss of peripheral and facial subcutaneous fat, increased intra-abdominal and visceral fat, breast hypertrophy and dorsocervical fat accumulation (buffalo hump).
4. 4).
115 Combination antiretroviral therapy has been associated with metabolic abnormalities such as hypertriglyceridaemia, hypercholesterolaemia, insulin resistance, hyperglycaemia and hyperlactataemia (see section 4.4).
Cerebellare koordinations - og balanceforstyrrelser, vangforestillinger, leversvigt, neuroser, fotoallergisk dermatitis, psykoser og selvmord.
Postmarketing experience with efavirenz has shown the following additional adverse reactions to occur in association with efavirenz-containing antiretroviral treatment regimens: cerebellar coordination and balance disturbances, delusion, hepatic failure, neurosis, photoallergic dermatitis, psychosis and completed suicide.
Hos børn var bivirkningerne generelt de samme som hos voksne patienter.
116 Paediatric patients: undesirable effects in children were generally similar to those of adult patients.
131 positionerne 98, 100, 101, 108, 138, 188, 190 eller 225, men med lavere frekvenser og ofte kun i kombination med K103N.
Substitutions at RT positions 98, 100, 101, 108, 138, 188, 190 or 225 were also observed, but at lower frequencies, and often only in combination with K103N.
To ud af tre undersøgte delavirdinresistente, kliniske isolater var krydsresistente over for efavirenz og indeholdt K103N- substitutionen.
Two of three delavirdine-resistant clinical isolates examined were cross-resistant to efavirenz and contained
132 Tabel 3:
Table 3:
Middelændring baseline- CD4 celletal
Mean change from baseline-CD4 cell count
fra
<
IDV + ZDV + 3TC a
118 IDV +
ACTG 382 er en igangværende ukontrolleret undersøgelse af 57 NRTI - erfarne, pædiatriske patienter (3 – 16 år), som beskriver farmakokinetik, antiviral aktivitet og sikkerhed af efavirenz i kombination med nelfinavir (20 – 30 mg/ kg indgivet 3 gange om dagen) og et eller flere NRTI’ ere.
ACTG 382 is an ongoing uncontrolled study of 57 NRTI-experienced paediatric patients (3 - 16 years) which characterises the pharmacokinetics, antiviral activity and safety of efavirenz in combination with nelfinavir (20 - 30 mg/ kg given three times a day) and one or more NRTIs.
133 procentdel af patienter med plasma HIV- RNA < 400 koPI' er/ ml efter 48 uger var 60% (95%, C. I.
The response rate, based on the NC = F analysis of the percentage of patients with plasma HIV-RNA < 400 copies/ ml at 48 weeks was 60% (95%, C. I.
Der blev set dosisrelaterede stigninger i Cmax og AUC for doser på op til 1. 600 mg.
Dose related increases in Cmax and AUC were seen for doses up to 1,600 mg; the increases were less than proportional
Stigningerne var mindre end proportionale, hvilket tyder på formindsket absorption ved højere doser.
119 suggesting diminished absorption at higher doses.
Tiden indtil peak plasmakoncentrationer (3 - 5 timer) ændredes ikke efter multiple doseringer, og steady- state plasmakoncentrationerne blev nået på 6 – 7 dage.
Time to peak plasma concentrations (3 - 5 hours) did not change following multiple dosing and steady-state plasma concentrations were reached in 6 - 7 days.
AUC og Cmax af en enkeldosis på 600 mg efavirenz filmovertrukne tabletter hos ikke- inficerede frivillige blev forøget med henholdsvis 28% (90% CI:
Effect of food: the AUC and Cmax of a single 600 mg dose of efavirenz film-coated tablets in uninfected volunteers was increased by 28% (90% CI:
4. 4).
22 – 33%) and 79% (90% CI:58 – 102%), respectively, when given with a high fat meal relative to when given under fasted conditions (see section 4.4).
Hos HIV- 1- inficerede patienter (n = 9), som fik efavirenz 200 – 600 mg 1 gang dagligt i mindst 1 måned, lå koncentrationerne i cerebrospinalvæsken mellem 0, 26 til 1, 19% (gennemsnit 0, 69%) af den tilsvarende plasmakoncentration.
In HIV-1 infected patients (n = 9) who received efavirenz 200 to 600 mg once daily for at least one month, cerebrospinal fluid concentrations ranged from 0.26 to 1.19% (mean 0.69%) of the corresponding plasma concentration.
Hos ikke- inficerede frivillige resulterede multiple doser på 200 – 400 mg per dag i 10 dage i en lavere grad af akkumulation (22 – 42% lavere) end forudset samt kortere halveringstid sammenlignet med enkeltdosisadministration (se nedenfor).
In uninfected volunteers, multiple doses of 200 - 400 mg per day for 10 days resulted in a lower than predicted extent of accumulation (22 - 42% lower) and a shorter terminal half-life compared with single dose administration (see below).
Efavirenz har en forholdsvis lang halveringstid på mindst 52 timer efter enkeltdoser og 40 – 55 timer efter multiple doser.
Elimination: efavirenz has a relatively long terminal half-life of at least 52 hours after single doses and 40 - 55 hours after multiple doses.
Selvom begrænsede data tyder på, at kvinder samt patienter fra Asien og Stillehavsøerne har højere påvirkningsgrad af efavirenz, synes deres tolerabilitet af efavirenz ikke at være mindre.
Gender, race, elderly: although limited data suggest that females as well as Asian and Pacific Island patients may have higher exposure to efavirenz, they do not appear to be less tolerant of efavirenz.
5. 3 Prækliniske sikkerhedsdata
120 5.3 Preclinical safety data
Tabletkerne Croscarmellosenatrium Mikrokrystallinsk cellulose Natriumlaurilsulfat Hydroxypropylcellulose Lactosemonohydrat Magnesiumstearat
Tablet core Croscarmellose sodium Microcrystalline cellulose Sodium laurilsulfate Hydroxypropylcellulose Lactose monohydrate Magnesium stearate
Filmovertræk Hypromellose (E464) Titandioxid (E171) Macrogol 400 Gul jernoxid (E172) Carnaubavoks
Film coating Hypromellose (E464) Titanium dioxide (E171) Macrogol 400 Yellow iron oxide (E172) Carnauba wax
135 6. 2 Uforligeligheder
6.2 Incompatibilities
6. 4 Særlige opbevaringsforhold
121 6.4 Special precautions for storage
Pakninger med 30 x 1 filmovertrukne tabletter i aluminiumperforeret enkeltdosis blister.
Packs of 30 x 1 film-coated tablets in aluminium perforated unit dose blisters.
EU/ 1/ 99/ 111/ 008 - HDPE- beholder EU/ 1/ 99/ 111/ 009 - Blister
EU/ 1/ 99/ 111/ 008 – bottle EU/ 1/ 99/ 111/ 009 – blister
136 1.
122 1.
Hver filmovertrukken tablet indeholder 20, 8 mg lactosemonohydrat.
Excipient: each film-coated tablet contains 20.8 mg of lactose monohydrate.
Gule, runde, præget med “ 113 ” på den ene side.
Yellow, round, debossed with “ 113 ” on one side.
Selvom der ikke er dokumenteret krydsresistens mellem efavirenz og PIere, er der i øjeblikket ikke tilstrækkelige data med hensyn til effekten af efterfølgende brug af PI- baseret kombinationsbehandling efter svigtende effekt af regimer, der inkluderer STOCRIN.
Although cross-resistance of efavirenz with PIs has not been documented, there are at present insufficient data on the efficacy of subsequent use of PI based combination therapy after failure of regimens containing STOCRIN.
Den anbefalede dosis af STOCRIN i kombination med en PI og/ eller NRTIer til patienter i alderen 3- 17 år er beskrevet i Tabel 1.
Paediatric patients (3 to 17 years): the recommended dose of STOCRIN in combination with a PI and/ or NRTIs for patients between 3 and 17 years of age is described in Table 1.
STOCRIN tabletter må kun administreres til børn, som med sikkerhed er i stand til at sluge tabletter.
STOCRIN tablets must only be administered to children who are able to reliably swallow tablets.
STOCRIN bør ikke anvendes til børn under
STOCRIN is not
5. 1 og 5. 2).
123 recommended for use in children below the age of 3 years or weighing less than 13 kg due to a lack of data on safety and efficacy in that age group (see sections 5.1 and 5.2).
STOCRIN Dosis (mg) * 200 250 300 350 400 600
STOCRIN Dose (mg )∗ 200 250 300 350 400 600
* STOCRIN 50 mg, 200 mg og 600 mg filmovertrukne tabletter er tilgængelige.
∗ STOCRIN 50 mg, 200 mg and 600 mg film-coated tablets are available.
4. 3 og 4. 4).
Patients should be monitored carefully for dose-related adversereactions, especially nervous system symptoms (see sections 4.3 and 4.4).
4. 4 Særlige advarsler og forsigtighedsregler vedrørende brugen
124 4.4 Special warnings and precautions for use
Som med alle andre non- nukleosid reverse transkriptasehæmmere (NNRTIere) forekommer der hurtigt resistent virus, når efavirenz administreres som monoterapi.
As with all other non-nucleoside reverse transcriptase inhibitors (NNRTIs), resistant virus emerges rapidly when efavirenz is administered as monotherapy.
138 Efavirenz og den faste kombinationstablet indeholdende efavirenz, emtricitabin og tenofovirdisoproxilfumarat, bør ikke administreres samtidigt.
Co-administration of efavirenz with the fixed combination tablet containing efavirenz, emtricitabine, and tenofovir disoproxil fumarate, is not recommended.
Patienter, som seponerede behandling med andre NNRTIere på grund af udslæt, kan have højere risiko for at udvikle udslæt under behandling med efavirenz.
Patients who discontinued treatment with other NNRTIs due to rash may be at higher risk of developing rash during treatment with efavirenz.
Der er set krampeanfald hos patienter i efavirenzbehandling, disse patienter havde sædvanligvis krampeanfald i anamnesen.
125 Seizures: convulsions have been observed in patients receiving efavirenz, generally in the presence of known medical history of seizures.
Patienter, som får krampestillende lægemidler, der hovedsageligt metaboliseres i leveren, som fx phenytoin, carbamazepin og phenobarbital, kan have brug for periodisk monitorering af plasmakoncentrationer.
Patients who are receiving concomitant anticonvulsant medicinal products primarily metabolised by the liver, such as phenytoin, carbamazepine and phenobarbital, may require periodic monitoring of plasma levels.
Det er blevet antaget, at der er en forbindelse mellem visceral lipomatose og PIere samt lipoatrofi og NRTIere.
A connection between visceral lipomatosis and PIs and lipoatrophy and NRTIs has been hypothesised.
Hos patienter, der er behandlet med andre lægemidler, der sættes i forbindelse med levertoksicitet, anbefales monitorering af leverenzymer.
126 In patients treated with other medicinal products associated with liver toxicity, monitoring of liver enzymes is also recommended.
Efavirenz bør derfor ikke gived til børn under 3 år.
Therefore, efavirenz should not be given to children less than 3 years of age.
Efavirenz filmovertrukne tabletter er ikke egnede til personer, som lider af sjældne, arvelige sygdomme som galactosæmi eller glucose/ galactose malabsorptionssyndrom.
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
Andre kemiske forbindelser, som er substrater af CYP3A4, kan muligvis få reducerede plasmakoncentrationer, når de indgives sammen med efavirenz.
Other compounds that are substrates of CYP3A4 may have decreased plasma concentrations when co-administered with efavirenz.
141 Tabel 2:
127 Table 2:
142
Indinavir:
Lægemidler i henhold til
128 Medicinal product by therapeutic
AUC: ↓ 25% (↓ 16 til ↓ 32) b Cmax: ↓ 17% (↓ 6 til ↓ 26) b Cmin: ↓ 50% (↓ 40 til ↓ 59) b Efavirenz:
AUC: ↓ 25% (↓ 16 to ↓ 32) b Cmax: ↓ 17% (↓ 6 to ↓ 26)b Cmin: ↓ 50% (↓ 40 to ↓ 59)b Efavirenz:
Lægemidler i henhold til
indinavir/ ritonavir.
144
Effects on drug levels
145
No dosage adjustment is necessary for either medicinal product.
Lægemidler i henhold til
130 Medicinal product by therapeutic
Dosisjustering er ikke tilgængelig for disse lægemidler.
efavirenz
AUC: ↑ 44% Cmax: ↑ 38%
AUC: ↑ 44% Cmax: ↑ 38% Voriconazole:
Når efavirenz administreres sammen med voriconazol, bør vedligeholdelsesdosis for voriconazol øges til 400 mg to gange dagligt, og efavirenz- dosis skal reduceres med 50%, dvs.
When efavirenz is co-administered with voriconazole, the voriconazole maintenance dose must be increased to 400 mg twice daily and the efavirenz dose must be reduced by 50%, i. e., to 300 mg
mg én gang dagligt.
once daily.
Hverken aluminium - / magnesiumhydroxidantacida eller famotidin ændrede absorptionen af efavirenz.
132 Medicinal product by therapeutic
148
co-administration with efavirenz
Lægemidler i henhold til
133 Medicinal product by therapeutic
150
No dosage adjustment is necessary for efavirenz.
Lægemidler i henhold til
134 Medicinal product by therapeutic
Ethinylestradiol/ efavirenz (50 µg enkeltdosis/ 400 mg én gang dagligt)
135
153 4. 6 Graviditet og amning
4.6 Pregnancy and lactation
Graviditet bør undgås hos kvinder, der er i behandling med efavirenz.
136 Women of childbearing potential: pregnancy should be avoided in women treated with efavirenz.
Møngden af data vedrørende anvendelse af efavirenz til gravide kvinder er begrænset.
Pregnancy: there are limited amount of data from the use of efavirenz in pregnant women.
154 udslættet inden for 1 måned ved fortsat behandling med efavirenz.
Rashes are usually mild-to-moderate maculopapular skin eruptions that occur within the first two weeks of initiating therapy with efavirenz.
Erfaring med efavirenz hos patienter, som er ophørt med andre antiretrovirale lægemidler af NNRTI- gruppen, er begrænset.
137 Experience with efavirenz in patients who discontinued other antiretroviral agents of the NNRTI class is limited.
Der er indberettet alvorlige psykiske bivirkninger hos patienter behandlet med efavirenz.
Psychiatric symptoms: serious psychiatric adverse reactions have been reported in patients treated with efavirenz.
For kontrollerede undersøgelser med 1. 008 patienter, der blev behandlet med regimer, der indeholder efavirenz i gennemsnitligt 1, 6 år og 635 patienter behandlet med kontrolregimer i gennemsnitligt 1, 3 år, er hyppigheden af specifikke, alvorlige psykiske bivirkninger beskrevet i detaljer nedenfor:
In controlled trials of 1,008 patients treated with regimens containing efavirenz for an average of 1.6 years and 635 patients treated with control regimens for an average of 1.3 years, the frequency of specific serious psychiatric events are detailed hereafter:
Patienter med psykiske lidelser i anamnesen synes at have større risiko for disse alvorlige, psykiske bivirkninger, hvor hyppigheden af hvert af de ovenstående tilfælde varierer fra 0, 3% for maniske reaktioner til 2, 0% for både svær depression og suicidaltanker.
Patients with a history of psychiatric disorders appear to be at greater risk of these serious psychiatric adverse reactions with frequencies of each of the above events ranging from 0.3% for manic reactions to 2.0% for both severe depression and suicidal ideation.
Frekvens defineres ved brug af følgende konvention:
Adverse reactions of moderate or greater severity with at least possible relationship to treatment regimen (based on investigator attribution) reported in clinical trials of efavirenz at the recommended dose in combination therapy (n = 1,008) are listed below.
Nervesystemet Almindelig
138 Nervous system disorders common
156 subkutant fedt perifert og i ansigtet, øget intraabdominalt og visceralt fedt, brysthypertrofi og dorsocervical fedtakkumulering (tyrenakke).
Lipodystrophy and metabolic abnormalities: combination antiretroviral therapy has been associated with redistribution of body fat (lipodystrophy) in HIV patients including the loss of peripheral and facial subcutaneous fat, increased intra-abdominal and visceral fat, breast hypertrophy and dorsocervical fat accumulation (buffalo hump).
4. 4).
139 Combination antiretroviral therapy has been associated with metabolic abnormalities such as hypertriglyceridaemia, hypercholesterolaemia, insulin resistance, hyperglycaemia and hyperlactataemia (see section 4.4).
I en undergruppe på 1. 008 patienter i en klinisk undersøgelse, blev der set asymptomatiske stigninger i serumamylase koncentrationen, til mere end 1, 5 gange den øvre normalgrænse hos 10% af de patienter, der blev behandlet med efavirenz og 6% af de patienter, der blev behandlet med kontrolregimer.
Amylase: in the clinical trial subset of 1,008 patients, asymptomatic increases in serum amylase levels greater than 1.5 times the upper limit of normal were seen in 10% of patients treated with efavirenz and 6% of patients treated with control regimens.
Størrelsen af ændringerne i lipidkoncentrationer kan være påvirket af faktorer såsom varighed af behandlingen og andre komponenter i det antiretrovirale regimen.
The magnitude of changes in lipid levels may be influenced by factors such as duration of therapy and other components of the antiretroviral regimen.
Hos børn var bivirkningerne generelt de samme som hos voksne patienter.
140 Paediatric patients: undesirable effects in children were generally similar to those of adult patients.
Non- nukleoside reverse transkriptasehæmmere, ATC kode:
ATC code:
158 over for efavirenz, var uafhængigt af de andre antivirale medikamenter, der anvendtes i kombination med efavirenz.
Cross resistance: cross resistance profiles for efavirenz, nevirapine and delavirdine in cell culture demonstrated that the K103N substitution confers loss of susceptibility to all three NNRTIs.
Krydsresistens:
141 the K103N substitution.
Virale isolater, der er indhentet fra PBMCer fra patienter, der var inkluderet i kliniske efavirenzundersøgelser, som viste tegn på behandlingssvigt (reboundfænomen af virus i blodet) blev vurderet med henblik på følsomhed over for NNRTIere.
Viral isolates recovered from PBMCs of patients enrolled in efavirenz clinical studies who showed evidence of treatment failure (viral load rebound) were assessed for susceptibility to NNRTIs.
Potentialet for krydsresistens mellem efavirenz og PIere er lille på grund af de forskellige enzymmål, der er involverede.
The potential for cross resistance between efavirenz and PIs is low because of the different enzyme targets involved.
1 års varighed med efavirenz i kombination med NRTIere og/ eller PIere har vist en reduktion i mængden af virus i blodet til under detektionsgrænsen i assayet og stigning i CD4 lymfocytter hos antiretroviral behandlingsnaive og NRTI- behandlede HIV- inficerede patienter.
Two controlled studies (006 and ACTG 364) of approximately one year duration with efavirenz in combination with NRTIs and/ or PIs, have demonstrated reduction of viral load below the limit of quantification of the assay and increased CD4 lymphocytes in antiretroviral therapy-naïve and NRTI-experienced HIV-infected patients.
Standarddoserne af NRTIere, givet hver 12. time, blev anvendt i hver af disse undersøgelser.
The standard doses of NRTIs given every 12 hours were used in each of these studies.
Det gennemsnitlige CD4 celletal ved baseline var 341 celler/ mm3, og gennemsnitligt HIV- RNA koncentration var 60. 250 kopier/ ml.
The mean baseline CD4 cell count was 341 cells/ mm3 and the mean baseline HIV-RNA level was 60,250 copies/ ml.
I analysen af responsraten (non- completer lig med failure analysen[ NC = F]), blev patienter, der udgik af studiet tidligt uanset grund, patienter som manglede en HIV- RNA måling, som enten var forudgået eller blev efterfulgt af en måling over assaygrænsen, formodet at have HIV- RNA over 50 eller over 400 kopier/ ml på de manglende tidspunkter.
In the analysis of responder rates (the non-completer equals failure analysis [NC = F]), patients who terminated the study early for any reason, or who had a missing HIV-RNA measurement that was either preceded or followed by a measurement above the limit of assay quantification were considered to have HIV-RNA above 50 or above 400 copies/ ml at the missing time points.
159 Tabel 3:
Table 3:
Effektresultater for undersøgelse 006
Efficacy results for study 006
Respons hyppigheder (NC = Fa)
Responder rates (NC = Fa) Plasma HIV-RNA
Middelændring
Mean change from baseline-CD4 cell count
400 kopier/ ml (95% C. I.) b
400 copies/ ml (95% C. I. b)
< 50 kopier/ ml (95% C. I.) b
< 50 copies/ ml (95% C. I. b)
Langtidsresultater efter 168 uger i Undersøgelse 006 (160 patienter fuldførte undersøgelsen med EFV+IDV, 196 med EFV+ZDV+3TC og 127 patienter med IDV+ZDV+3TC) tyder på varigt respons med hensyn til mængden af patienter med HIV RNA < 400 kopier/ ml, HIV RNA < 50 kopier/ ml og med hensyn til middelændring fra baseline af CD4 celletal.
Long-term results at 168 weeks of study 006 (160 patients completed study on treatment with EFV +IDV, 196 patients with EFV + ZDV + 3TC and 127 patients with IDV + ZDV + 3TC, respectively), suggest durability of response in terms of proportions of patients with HIV-RNA < 400 copies/ ml, HIV-RNA < 50 copies/ ml and in terms of mean change from baseline CD4 cell count.
Respons hyppigheder (NC = Fa) Plasma HIV- RNA
Responder rates (NC = Fa)
< 500 kopier/ ml
< 500 copies/ ml
< 50 kopier/ ml
< 50 copies/ ml
EFV + NFV + NRTIere EFV + NRTIere NFV + NRTIere
EFV + NFV + NRTIs EFV + NRTIs NFV + NRTIs
< 400 kopier/ ml
< 400 copies/ ml
EFV + IDV + NRTIere IDV + NRTIere a
EFV + IDV + NRTIs IDV + NRTIs a
ACTG 382 er en igangværende ukontrolleret undersøgelse af 57 NRTI - erfarne, pædiatriske patienter (3 – 16 år), som beskriver farmakokinetik, antiviral aktivitet og sikkerhed af efavirenz i kombination med nelfinavir (20 – 30 mg/ kg indgivet 3 gange om dagen) og et eller flere NRTIere.
ACTG 382 is an ongoing uncontrolled study of 57 NRTI-experienced paediatric patients (3 - 16 years) which characterises the pharmacokinetics, antiviral activity and safety of efavirenz in combination with nelfinavir (20 - 30 mg/ kg given three times a day) and one or more NRTIs.
Responshyppigheden, der er baseret på NC = F analyse af den procentdel af patienter med plasma HIV- RNA < 400 kopier/ ml efter 48 uger var 60% (95%, C. I.
The response rate, based on the NC = F analysis of the percentage of patients with plasma HIV-RNA < 400 copies/ ml at 48 weeks was 60% (95%, C. I.
40, 66), der er baseret på procentdelen af patienter med plasma HIV- RNA < 50 kopier/ ml.
40, 66) based on percentage of patients with plasma HIV-RNA < 50 copies/ ml.
5. 2 Farmakokinetiske egenskaber
143 5.2 Pharmacokinetic properties
De højeste efavirenz- plasmakoncentrationer på 1, 6 - 9, 1 μM blev nået senest 5 timer efter orale enkeltdoser på 100 – 1. 600 mg indgivet til ikke- inficerede frivillige.
Absorption: peak efavirenz plasma concentrations of 1.6 - 9.1 μ M were attained by 5 hours following single oral doses of 100 mg to 1,600 mg administered to uninfected volunteers.
Selvom begrænsede data tyder på, at kvinder samt patienter fra Asien og Stillehavsøerne har højere påvirkningsgrad af efavirenz, synes deres tolerabilitet af efavirenz ikke at være mindre.
144 Gender, race, elderly: although limited data suggest that females as well as Asian and Pacific Island patients may have higher exposure to efavirenz, they do not appear to be less tolerant of efavirenz.
Tabletkerne Croscarmellosenatrium Mikrokrystallinsk cellulose Natriumlaurilsulfat Hydroxypropylcellulose Lactosemonohydrat Magnesiumstearat.
Tablet core Croscarmellose sodium Microcrystalline cellulose Sodium laurilsulfate Hydroxypropylcellulose Lactose monohydrate Magnesium stearate
Filmovertræk Hypromellose (E464) Titandioxid (E171) Macrogol 400 Gul jernoxid (E172) Carnaubavoks.
Film coating Hypromellose (E464) Titanium dioxide (E171) Macrogol 400 Yellow iron oxide (E172) Carnauba wax
162 6. 2 Uforligeligheder
6.2 Incompatibilities
6. 3 Opbevaringstid
145 6.3 Shelf life
EU/ 1/ 99/ 111/ 010 – glas
EU/ 1/ 99/ 111/ 010 - bottle
28 maj 1999
28 May 1999.
163 1.
146 1.
Hver filmovertrukken tablet indeholder 83, 2 mg lactosemonohydrat.
Excipient: each film-coated tablet contains 83.2 mg of lactose monohydrate.
Gule, runde, præget med “ 223 ” på den ene side.
Yellow, round, debossed with “ 223 ” on one side.