natgillin/translations-raw huggingface dataset:
Virkning af PREZISTA co- administreret med 100 mg ritonavir hos ART- behandlingserfarne patienter Dokumentationen for virkningen af PREZISTA co- administreret med ritonavir (600/ 100 mg x 2), hos behandlingserfarne patienter er baseret på 48 ugers- analysen af fase III- forsøget TITAN hos behandlingserfarne lopinavir- naive patienter og på analysen af 96 ugers data fra fase IIb- forsøgene POWER 1, 2 og 3 hos patienter med høj grad af PI- resistens.
Efficacy of PREZISTA co-administered with 100 mg ritonavir in ART-experienced patients The evidence of efficacy of PREZISTA co-administered with ritonavir (600/100 mg b.i.d.) in treatment-experienced patients is based on the 48 weeks analysis of the Phase III trial TITAN in treatment-experienced lopinavir naïve patients and on the analyses of 96 weeks data from the Phase IIb trials POWER 1, 2 and 3 in patients with high level of PI resistance.
Gennemsnitlig HIV- 1 RNA log ændring fra baseline (log10 kopier/ ml) c
mean HIV-1 RNA log change from baseline (log10 copies/ml)c
median CD4+ celletalændring fra baseline (x 106/ l) c a I overensstemmelse med TLOVR- algoritmen b
median CD4+ cell count change from baseline (x 106/l)c a
HIV- 1- inficerede patienter, som kunne indgå i disse forsøg, havde tidligere oplevet behandlingssvigt med mere end ét PI- indeholdende behandlingsregime.
HIV-1 infected patients who were eligible for these trials had previously failed more than 1 PI containing regimen.PREZISTA co-administered with 100 mg ritonavir plus an optimised background regimen (OBR) was compared to a control group receiving an investigator-selected PI(s) regimen plus an OBR.
81 (61, 8%) 20 (16, 1%)
81 (61.8%) 20 (16.1%) 45.7% (35.0%; 56.4%)d 39
41 I en pooled analyse af grupperne, der modtog 600/ 100 mg x 2, fra POWER - og DUET- forsøgene var tilstedeværelsen ved baseline af mindst 3 af mutationerne V11I, V32I, L33F, I47V, I50V, I54L eller M, T74P, L76V, I84V or L89V forbundet med et reduceret virologisk respons over for PREZISTA co- administreret med 100 mg ritonavir.
Baseline genotype or phenotype and virologic outcome In a pooled analysis of the 600/100 mg b.i.d. groups of the POWER and DUET trials, the presence at baseline of 3 or more of mutations V11I, V32I, L33F, I47V, I50V, I54L or M, T74P, L76V, I84V or L89V was associated with a decreased virologic response to PREZISTA co-administered with 100 mg ritonavir.
Respons( HIV- 1 RNA < 50 kopier/ ml ved uge 24) over for PREZISTA co- administreret med ritonavir (600/ 100 mg x 2) efter genotype ved baseline * og efter brug af enfuvirtid (ENF):
Response (HIV-1 RNA < 50 copies/ml at week 24) to PREZISTA co-administered with ritonavir (600/100 mg b.i.d.) by baseline genotype * and by use of enfuvirtide (ENF):
* Antal mutationer fra listen af mutationer assicieret med et formindsket respons over for PREZISTA/ ritonavir (V11I, V32I, L33F, I47V, I50V, I54L eller M, T74P, L76V, I84V eller L89V)
* Number of mutations from the list of mutations associated with a diminished response to PREZISTA/ritonavir (V11I, V32I, L33F, I47V, I 50V, I54L or M, T74P, L76V, I84V or L89V)
Darunavir- fænotype ved baseline
40 Baseline darunavir phenotype
Eksponeringen for darunavir var højere hos HIV- 1- inficerede patienter end hos raske forsøgspersoner.
Exposure to darunavir was higher in HIV-1 infected patients than in healthy subjects.
42 kan muligvis forklares ved de højere koncentrationer af α1- syre glycoprotein (AAG) hos HIV- 1 - inficerede patienter, hvilket resulterer i højere binding af darunavir til plasma- AAG og derfor i højere plasmakoncentrationer.
The increased exposure to darunavir in HIV-1 infected patients compared to healthy subjects may be explained by the higher concentrations of alpha-1-acid glycoprotein (AAG) in HIV-1 infected patients, resulting in higher darunavir binding to plasma AAG and, therefore, higher plasma concentrations.
Den terminale halveringstid for darunavir var ca.
41 respectively.
Ældre patienter En populationsfarmakokinetisk analyse af HIV- inficerede patienter viste, at farmakokinetikken for darunavir ikke er meget anderledes i aldersgruppen 18- 75 år vurderet hos HIV- inficerede patienter (se pkt.
Elderly Population pharmacokinetic analysis in HIV infected patients showed that darunavir pharmacokinetics are not considerably different in the age range (18 to 75 years) evaluated in HIV infected patients (see section 4.4).
Køn En populationsfarmakokinetisk analyse viste en lidt højere eksponering for darunavir hos HIV - inficerede kvinder i forhold til mænd.
Gender Population pharmacokinetic analysis showed a slightly higher darunavir exposure in HIV infected females compared to males.
I toksikologiforsøg med gentagne doser til mus, rotter og hunde var der kun begrænset virkning af behandling med darunavir.
In repeated-dose toxicology studies in mice, rats and dogs, there were only limited effects of treatment with darunavir.
Eksponeringsniveauerne var lavere end ved den anbefalede kliniske dosis til mennesker.
In a pre- and
I en vurdering af præ - og postnatal udvikling hos rotter medførte darunavir med og uden ritonavir en forbigående reduktion i vægtstigning hos afkommet inden fravænning, og åbning af øjne og ører skete lidt senere end normalt.
42 postnatal development assessment in rats, darunavir with and without ritonavir, caused a transient reduction in body weight gain of the offspring pre-weaning and there was a slight delay in the opening of eyes and ears.
Hos mennesker nærmer aktiviteten af de lægemiddelmetaboliserende enzymer sig værdierne for voksne omkring en alder på 1 til 3 år.
In humans, the activity of drug-metabolising enzymes approaches adult values by 1 to 3 years of age.
44 Darunavir er blevet vurderet for carcinogent potentiale ved peroral tvangsfodring af mus og rotter i op til 104 uger.
Darunavir was evaluated for carcinogenic potential by oral gavage administration to mice and rats up to 104 weeks.
2 år
43 2 years
Klart, hvidt plastikglas på 160 ml af polyetylen med høj densitet (HDPE), der indeholder 60 tabletter, og som har børnesikret lukkeanordning af polypropylen (PP).
Opaque, white, high density polyethylene (HDPE) plastic, 160 ml bottle containing 60 tablets, fitted with polypropylene (PP) child resistant closure.
Et glas.
One bottle
45 6. 6 Regler for destruktion
6.6 Special precautions for disposal
46 1.
44 1.
PREZISTA 600 mg filmovertrukne tabletter.
PREZISTA 600 mg film-coated tablets
Hver tablet indeholder 2, 750 mg Sunset yellow FCF (E110).
Each tablet contains 2.750 mg sunset yellow FCF (E110).
Orange, oval tablet med "600MG" præget på den ene side og "TMC" præget på den anden side.
Orange oval shaped tablet, debossed with “600MG” on one side and “TMC” on the other side.
Voksne Den anbefalede dosis af PREZISTA er 600 mg to gange dagligt (x 2) indtaget sammen med ritonavir 100 mg, dvs. også to gange dagligt.
Adults The recommended dosage of PREZISTA is 600 mg twice daily (b.i.d.) taken with ritonavir 100 mg b.i.d. and with food.
Børn og unge PREZISTA bør ikke anvendes til børn og unge, da der ikke foreligger tilstrækkelig data om sikkerhed, virkning og farmakokinetik.
Children and adolescents PREZISTA is not recommended for use in children and adolescents due to insufficient data on safety, efficacy and pharmacokinetics.
4. 4 og 5. 2).
Elderly Limited information is available in this population and therefore PREZISTA should be used with caution in this age group (see sections 4.4 and 5.2).
Nedsat leverfunktion Darunavir metaboliseres i leveren.
Hepatic impairment Darunavir is metabolised by the hepatic system.
Der foreligger ingen farmakokinetiske data for patienter med svært nedsat leverfunktion.
No pharmacokinetic data are available in
47 en forværring af stoffets sikkerhedsprofil.
45 patients with severe hepatic impairment.
Hvis en patient bliver opmærksom på, at en dosis PREZISTA og/ eller ritonavir er blevet glemt inden for 6 timer efter det tidspunkt, hvor den normalt tages, skal patienten instrueres i at tage den ordinerede dosis PREZISTA og ritonavir med mad så hurtigt som muligt.
In case a dose of PREZISTA and/or ritonavir was missed within 6 hours of the time it is usually taken, patients should be instructed to take the prescribed dose of PREZISTA and ritonavir with food as soon as possible.
4. 5).
These active substances include e.g. antiarrhythmics (amiodarone, bepridil, quinidine, systemic lidocaine), antihistamines (astemizole, terfenadine), ergot derivatives (e.g. dihydroergotamine, ergonovine, ergotamine, methylergonovine), gastrointestinal motility agents (cisapride), neuroleptics (pimozide, sertindole), sedatives/hypnotics (triazolam, midazolam administered orally (for caution on parenterally administered midazolam, see section 4.5)) and HMG-CoA reductase inhibitors (simvastatin and lovastatin) (see section 4.5).
48 Darunavir binder sig hovedsageligt til α1- syre- glycoprotein.
46 Darunavir binds predominantly to α1-acid glycoprotein.
PREZISTA skal anvendes med forsigtighed hos patienter med kendt sulfonamidallergi.
PREZIST A should be used with caution in patients with a known sulphonamide allergy.
Klinisk undersøgelse bør omfatte vurdering af fysiske tegn på omfordeling
Clinical examination should include evaluation for physical signs of fat redistribution.
Det bør overvejes at måle fastende serumlipider og blodglukose.
47 fasting serum lipids and blood glucose.
Dette kan skyldes tilstedeværelsen af lav- dosis ritonavir.
A clinical study utilising a cocktail of drugs that are metabolised by cytochromes CYP2C9, CYP2C19 and CYP2D6 demonstrated an increase in CYP2C9 and CYP2C19 activity and inhibition of CYP2D6 activity in the presence of PREZISTA/rtv, which may be attributed to the presence of low dose ritonavir.
Co- administration af darunavir og ritonavir og lægemidler, som primært metaboliseres af CYP2C9 (såsom warfarin) og CYP2C19 (såsom methadon) kan resultere i nedsat systemisk eksponering af disse lægemidler, hvilket kan nedsætte eller forkorte deres terapeutiske effekt.
Co-administration of darunavir and ritonavir and medicinal products primarily metabolised by CYP2C9 (such as warfarin) and CYP2C19 (such as methadone) may result in
50 Selvom effekten på CYP2C8 kun er blevet undersøgt in vitro, kan co- administration af darunavir og ritonavir og lægemidler, som primært metaboliseres af CYP2C8 (såsom paclitaxel, rosiglitazon, repaglinid), resultere i nedsat systemisk eksponering af disse lægemidler, hvilken kan nedsætte eller forkorte deres terapeutiske effekt.
Although the effect on CYP2C8 has only been studied in vitro, co-administration of darunavir and ritonavir and medicinal products primarily metabolised by CYP2C8 (such as paclitaxel, rosiglitazone, repaglinide) may result in decreased systemic exposure to such medicinal products, which could decrease or shorten their therapeutic effect.
51 Interaktioner – Darunavir/ ritonavir med andre antiretrovirale midler end proteasehæmmere Co- administreret
Interactions – Darunavir/ritonavir with Antiretroviral Agents other than Protease Inhibitors
lægemiddel
Co-administered Medicinal Product (mg)
(dosis er angivet i mg, med mindre andet er anført)
darunavir/ritonavir (mg)
mg, med mindre andet er anført)
Product Assessed
300/ 100 x 2 #
300/100 b.i.d.#
Efavirenz Darunavir
Efavirenz Darunavir
600/ 100 x
600/1
↓ 37% ↓ 49%
Etravirine
Darunavir
↓ 37%
↔
↓ 49%
300/ 100 x
30
Interaktioner – Darunavir/ ritonavir med non- antiretrovirale co- administrerede lægemidler
Interactions – Darunavir/ritonavir with Non-antiretroviral co-administered Medicinal Products Co-administered
(dosis er angivet i mg, med mindre andet er anført)
Medicinal Product (mg)
Darunavir/ ritonavir øger plasmakoncentrationerne af digoxin.
50 Darunavir/ritonavir increases the plasma concentrations of digoxin.
400/ 100 x
400/100 b.i
Ketoconazol 200 x 2 400/ 100 x 2 # Ketoconazol
400/ 100 b.i.d.# Ketoconazole
53 Itraconazol
Itraconazole
Ligesom ketoconazole er itraconazol en potent hæmmer af og substrat af for CYP3A4.
Itraconazole, like ketoconazole, is a potent inhibitor as well as substrate of CYP3 A4.
54 Felodipin Nicardipin Nifedipin Opioder
55-150 q.d.
Derfor anbefales klinisk monitorering, da veligeholdelsesbehandling hos nogle patienter kan kræve en justering.
PDE-5 inhibitors
PDE- 5- hæmmere Sildenafil Vardenafil Tadalafil Rifamyciner
52 Sildenafil Vardenafil Tadalafil Rifamycines
Rifabutin Sedativa/ hypnotika
Rifabutin
55 Parenteral midazolam
Sedatives/Hypnotics Parenteral midazolam
Der er ikke udført lægemiddelinteraktionsstudier for co- administration af PREZISTA/ ritonavir med benzodiazepiner.
No drug interaction study has been performed for the co-administration of PREZIST A/ritonavir with benzodiazepines.
Selektive serotonin genoptagshæmmere (SSRI’ er) Paroxetin
Selective Serotonin Reuptake Inhibitors (SSRIs) Paroxetine
Hvis SSRI’ er co- administreres med PREZISTA og ritonavir, er den anbefalede fremgangsmåde en forsigtig dosistitrering af SSRI’ en på grundlag af en klinisk vurdering af responset på det antidepressive middel.
53 If SSRIs are co-administered with PREZISTA and ritonavir, the recommended approach is a dose titration of the SSRI based on a clinical assessment of antidepressant response.
56 Der er ikke udført tilstrækkelige og velkontrollerede forsøg med darunavir hos gravide kvinder.
Pregnancy There are no adequate and well controlled studies with darunavir in pregnant women.
Der er dog rapporteret om svimmelhed hos nogle patienter under behandlingen med regimer, der indeholder PREZISTA, co- administreret med 100 mg ritonavir.
However, dizziness has been reported in some patients during
4. 8).
54 treatment with regimens containing PREZISTA co-administered with 100 mg ritonavir and should be borne in mind when considering a patient’s ability to drive or operate machinery (see section 4.8).
57 Metabolisme og ernæring almindelig
Metabolism and nutrition disorders common
ikke almindelig Øjne
55 uncommon Eye disorders
58 ikke almindelig Lever og galdeveje
uncommon
ikke almindelig Nyrer og urinveje
56 Musculoskeletal and connective tissue disorders uncommon
59 I kliniske forsøg (n=1. 968) forekom udslæt (alle sværhedsgrader og muligt relateret til behandlingen) hos 5, 6% af patienterne, som blev behandlet med PREZISTA.
In clinical trials (n=1,968), rash (all grades, at least possibly related) occurred in 5.6% of patients treated with PREZISTA.
4. 4).
57 Combination antiretroviral therapy has been associated with redistribution of body fat (lipodystrophy) in HIV patients, including loss of peripheral and facial subcutaneous fat, increased intra-abdominal and visceral fat, breast hypertrophy and dorsocervical fat accumulation (buffalo hump) (see section 4.4).
60 Patienter co- inficeret med hepatitis B - og/ eller hepatitis C- virus Blandt 1. 968 behandlingserfarne patienter, der fik PREZISTA, co- administreret med ritonavir 600/ 100 mg x 2, havde 236 patienter også hepatitis B eller C.
Patients co-infected with hepatitis B and/or hepatitis C virus Among 1,968 treatment-experienced patients receiving PREZISTA co-administered with ritonavir 600/100 mg b.i.d., 236 patients were co-infected with hepatitis B or C.
Antiviral aktivitet in vitro Darunavir udviser aktivitet mod laboratoriestammer og kliniske isolater af HIV- 1 og laboratoriestammer af HIV- 2 i akut inficerede T- cellelinjer, monocytter fra perifert humant blod og humane monocytter/ makrofager med mediane EC50 værdier fra 1, 2 til 8, 5 nM (0, 7 til 5, 0 ng/ ml).
Antiviral activity in vitro Darunavir exhibits activity against laboratory strains and clinical isolates of HIV-1 and laboratory strains of HIV-2 in acutely infected T-cell lines, human peripheral blood mononuclear cells and
De aminosyresubstitutioner, der udvikledes ved
53-641-fold change in EC50 values [FC]) from 9 HIV-1 strains harbouring multiple PI Resistance-Associated Mutations (RAMs) showed that a minimum of 8 darunavir in vitro selected mutations were required in the HIV-1 protease to render a virus resistant (FC > 10) to darunavir.
61 PREZISTA, co- administreret med ritonavir (600/ 100 mg x 2), i ≥ 20% af isolaterne fra forsøgspersoner, der oplevede virologisk svigt ved tilbagefald, blev i den poolede analyse af POWER 1, 2 og 3 (se underafsnit om klinisk erfaring) samt DUET 1 - og 2- forsøgene (TMC125- C206 og TMC125- C216) identificeret til, at være V32I, I54L og L89V.
In a pooled analysis of the POWER 1, 2 and 3 (see Clinical experience subsection) and DUET 1 and 2 (TMC125-C206 and TMC125-C216) trials the amino acid substitutions identified that developed on PREZISTA co-administered with ritonavir (600/100 mg b.i.d.) in ≥ 20% of the isolates from subjects who experienced virologic failure by rebound were V32I, I54L and L89V.
Den gennemsnitlige baseline plasma HIV- 1 RNA var 4. 33 log10 kopier/ ml og medianen af baseline CD4+ celletal var 235 x 106 celler/ l (spændvidde 3 – 831 x 106 celler/ l) i PREZISTA/ ritonavir- behandlingsarmen.
59 The mean baseline plasma HIV-1 RNA was 4.33 log10 copies/ml and the median baseline CD4+ cell count was 235 x 106 cells/l (range 3 – 831 x 106 cells/l) in the PREZISTA/ritonavir arm.
TITAN Resultat
TITAN Outcomes
median CD4+ celletalændring fra baseline (x 106/ l) c
median CD4+ cell count change from baseline (x 106/l)c a
62 a Pålagt ifølge TLOVR- algoritmen b Baseret på en normal approximation af forskellen i% respons c NC=F d Forskelle i gennemsnit
Imputations according to the TLOVR algorithm b Based on a normal approximation of the difference in% response c NC=F d Difference in means
HIV- 1 RNA log10 gennemsnitlig ændring fra baseline (log10 kopier/ ml) a
60 HIV-1 RNA log10 mean change from baseline (log10 copies/ml)a
103 17
103
86 (57; 114) d
86 (57; 114)d
81 (61, 8%) 20 (16, 1%)
20 (16.1%)
45, 7% (35, 0%; 56, 4%) d
45.7% (35.0%; 56.4%)d
HIV RNA < 400 kopier/ mlc
HIV RNA < 400 copies/mlc
72 (55, 0%) 18 (14, 5%)
18 (14.5%)
40. 4% (29, 8%; 51, 1%) d
40.4% (29.8%; 51.1%)d
63 Dataanalyser gennem 96 ugers behandling i de tre POWER- forsøg påviste vedvarende antiretroviral effekt og immunologisk fordel.
Analyses of data through 96 weeks of treatment in the three POWER trials demonstrated sustained antiretroviral efficacy and immunological benefit.
Genotype og fænotype ved baseline og virologisk udfald I en pooled analyse af grupperne, der modtog 600/ 100 mg x 2, fra POWER - og DUET- forsøgene var tilstedeværelsen ved baseline af mindst 3 af mutationerne V11I, V32I, L33F, I47V, I50V, I54L eller M, T74P, L76V, I84V or L89V forbundet med et reduceret virologisk respons over for PREZISTA co- administreret med 100 mg ritonavir.
Baseline genotype or phenotype and virologic outcome In a pooled analysis of the 600/100 mg b.i.d. groups of the POWER and DUET trials, the presence at baseline of 3 or more of mutations V11I, V32I, L33F, I47V, I50V, I54L or M, T74P, L76V, I84V or L89V was associated with a decreased virologic response to PREZISTA co-administered with 100 mg ritonavir.
Darunavir- fænotype ved baseline (ændring i følsomhed i forhold til reference) blev vist at være en indikator for virologisk udfald.
61 Baseline darunavir phenotype (shift in susceptibility relative to reference) was shown to be a predictive factor of virologic outcome.
Darunavir- fænotype ved baseline
Baseline darunavir phenotype
64 Alle
All ranges
Man har identificeret mindst 3 oxidative metabolitter af darunavir hos mennesker.
At least 3 oxidative metabolites of darunavir have been identified in
De viste alle aktivitet, der var mindst 10 gange mindre end aktiviteten af darunavir over for vildtype HIV.
62 humans; all showed activity that was at least 10-fold less than the activity of darunavir against wild type HIV.
41, 2% og 7, 7% af den administrerede dosis i henholdsvis fæces og urin.
Unchanged darunavir accounted for approximately 41.2% and 7.7% of the administered dose in faeces and urine, respectively.
65 Særlige populationer Pædiatriske patienter Der foreligger ingen farmakokinetiske data for børn og unge.
Special Populations Paediatrics There are no pharmacokinetic data available in children and adolescents.
Hos rotter medførte kombinationen af darunavir og ritonavir en lille stigning i virkning på parametre for røde blodlegemer, lever og skjoldbruskkirtlen og øget incidens af pankreasfibrose (kun hos hanrotter) sammenlignet med behandling med darunavir alene.
In the dog, no major toxicity
Hos hunde blev der ikke identificeret nogen større toksicitetsfund eller målorganer op til eksponeringer svarende til klinisk eksponering ved den anbefalede dosis.
63 findings or target organs were identified up to exposures equivalent to clinical exposure at the recommended dose.
Darunavir i kombination med ritonavir medførte et fald i antallet af hvalpe, der udviste forskrækkelsesrespons på dag 15 af diegivningen og en reduceret overlevelse for hvalpene
Darunavir in combination with ritonavir caused a reduction in the number of pups that exhibited the startle response on day 15 of lactation and a reduced pup survival during lactation.
Filmovertræk Poly( vinyl alkohol) – delvist hydrolyseret Macrogol 3350 Titanium dioxid (E171) Talkum Sunset yellow FCF (E110)
Tablet film-coat Poly(vinyl alcohol) – partially hydrolyzed Macrogol 3350
67 6. 3 Opbevaringstid
6.3 Shelf life
68 BILAG II
65 ANNEX II
69 A.
66 A.
Pharmacovigilancesystem Indehaveren af markedsføringstilladelsen skal sikre, at der er et fungerende pharmacovigilance- system på plads, som beskrevet i version 3 (dateret 28. juni 2007) i Modul 1. 8. 1 af ansøgningen om markedføringstilladelse, før og så længe produktet er på markedet.
The MAH must ensure that the system of pharmacovigilance, as described in version 3 (dated 28 June 2007) presented in Module 1.8.1. of the Marketing Authorisation Application, is in place and functioning before and whilst the product is on the market.
Risk Management- Plan Indehaveren af markedsføringstilladelsen forpligter sig til at gennemføre forsøg og yderligere pharmacovigilance- aktiviteter beskrevet i Pharmacovigilanceplanen, som beskrevet i version 7 (dateret 31. juli 2008) af Risk Management- planen (RMP) i Modul 1. 8. 2 af ansøgningen om markedføringstilladelse samt efterfølgende opdateringer af RMP’ en, som er godkendt af CHMP.
The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in version 7 (dated 31 July 2008) of the Risk Management Plan (RMP) presented in Module 1.8.2. of the Marketing Authorisation Application and any subsequent updates of the RMP agreed by the CHMP.
I henhold til ” CHMP Guideline on Risk Management Systems for medicinal products for human use ” skal den opdaterede RMP indsendes samtidig med næste Periodic Safety Update Report (PSUR).
As per the CHMP Guideline on Risk Management Systems for medicinal products for human use, the updated RMP should be submitted at the same time as the next Periodic Safety Update Report (PSUR).
Når der modtages nye informationer, der kan påvirke de nuværende sikkerhedsspecifikationer, pharmacovigilance- planen eller risikominimeringsaktiviteterne
When new information is received that may impact on the current Safety Specification, Pharmacovigilance Plan or risk minimisation activities
Inden for 60 dage efter opnåelse af en vigtig (pharmacovigilance - eller risikominimerings -) milepæl
Within 60 days of an important (pharmacovigilance or risk minimisation) milestone being reached
På anmodning fra EMEA
At the request of the EMEA.
70 BILAG III
67 ANNEX III
71 A.
68 A.
72 MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE OG PÅ DEN INDRE EMBALLAGE
69 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
YDRE ÆSKE/ FLASKE ETIKETTE
OUTER CARTON / BOTTLE LABEL
73 11.
11.
INFORMATION I BRAILLE- SKRIFT (kun på den ydre pakke)
INFORMATION IN BRAILLE (this is only applicable to the outer pack)
74 MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE OG PÅ DEN INDRE EMBALLAGE
71 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
75 11.
11.
78 B.
75 B.
79 INDLÆGSSEDDEL:
76 PACKAGE LEAFLET:
PREZISTATM - 300 mg filmovertrukne tabletter darunavir
PREZISTA 300 mg film -coated tablets darunavir
- Lægen har ordineret PREZISTA til dig personligt.
- This medicine has been prescribed for you.