natgillin/translations-raw huggingface dataset:
In vitro binding af emtricitabin til humane plasmaproteiner var < 4% og uafhængig af koncentrationen over området på 0, 02- 200 µg/ ml.
In vitro binding of emtricitabine to human plasma proteins was < 4% and independent of concentration over the range of 0.02-200 µg/ ml.
Det tilsyneladende fordelingsvolumen efter intravenøs indgivelse af emtricitabin var 1, 4±0, 3 l/ kg, hvilket indikerer, at emtricitabin fordeles i stort omfang i hele legemet til både intracellulære og ekstracellulære væskerum.
The apparent volume of distribution after intravenous administration of emtricitabine was 1.4±0.3 l/ kg, indicating that emtricitabine is widely distributed throughout the body to both intracellular and extracellular fluid spaces.
4% af dosen).
The biotransformation of emtricitabine includes oxidation of the thiol moiety to form the 3'-sulphoxide diastereomers (approximately 9% of dose) and conjugation with glucuronic acid to form 2'-O-glucuronide (approximately 4% of dose).
Emtricitabin hæmmede ikke in vitro lægemiddelmetabolisme medieret af følgende humane CYP450 - isoenzymer:
Emtricitabine did not inhibit in vitro drug metabolism mediated by the following human CYP450 isoenzymes:
Endvidere hæmmede emtricitabin ikke uridin- 5 '- difosfoglucuronyl- transferase, det enzym, som er ansvarlig for glucuronidation.
Also, emtricitabine did not inhibit uridine-5'-diphosphoglucuronyl transferase, the enzyme responsible for glucuronidation.
Emtricitabins systemiske clearance var i gennemsnit 307 ml/ min (4, 03 ml/ min/ kg).
The systemic clearance of emtricitabine averaged 307 ml/ min (4.03 ml/ min/ kg).
Emtricitabins farmakokinetik er proportional med dosen over dosisområdet 25- 200 mg efter en eller flere indgivelser.
The pharmacokinetics of emtricitabine are proportional to dose over the dose range of 25-200 mg following single or repeated administration.
Intracellulær farmakokinetik:
Intracellular pharmacokinetics:
I en klinisk undersøgelse var emtricitabin- trifosfats intracellulære halveringstid i mononukleære celler i perifert blod 39 timer.
In a clinical study, the intracellular half-life of emtricitabine-triphosphate in peripheral blood mononuclear cells was 39 hours.
Intracellulære trifosfatniveauer steg med dosen, men nåede et fast, højt niveau ved doser på 200 mg eller derover.
Intracellular triphosphate levels increased with dose, but reached a plateau at doses of 200 mg or greater.
Voksne med nyreinsufficiens:
Adults with renal insufficiency:
Farmakokinetiske parametre blev bestemt efter indgivelse af en enkelt dosis af 200 mg emtricitabin hårde kapsler til 30 ikke- HIV- inficerede forsøgspersoner med forskellige grader af nyreinsufficiens.
Pharmacokinetic parameters were determined following administration of a single dose of 200 mg emtricitabine hard capsules to 30 non-HIV infected subjects with varying degrees of renal insufficiency.
Forsøgspersoner blev grupperet i henhold til kreatininclearance ved baselinie (> 80 ml/ min som normal nyrefunktion; 50- 80 ml/ min som mildt nedsat nyrefunktion; 30- 49 ml/ min som moderat nedsat nyrefunktion; < 30 ml/ min som svært nedsat nyrefunktion; < 15 ml/ min som svigt af nyrefunktion med behov for hæmodialyse).
Subjects were grouped according to baseline creatinine clearance (> 80 ml/ min as normal function; 50-80 ml/ min as mild impairment; 30-49 ml/ min as moderate impairment; < 30 ml/ min as severe impairment; < 15 ml/ min as functionally anephric requiring haemodialysis).
10 Den systemiske emtricitabineksponering (gennemsnit ± standardafvigelsen) steg fra 11, 8±2, 9 µg· t/ ml hos forsøgspersoner med normal nyrefunktion til 19, 9±1, 1, 25, 0±5, 7 og 34, 0±2, 1 µg· t/ ml hos patienter med henholdsvis mildt, moderat og svært nedsat nyrefunktion.
The systemic emtricitabine exposure (mean ± standard deviation) increased from 11.8±2.9 µg·h/ ml in subjects with normal renal function to 19.9±1.1, 25.0±5.7 and 34.0±2.1 µg·h/ ml, in patients with mild, moderate and severe renal impairment, respectively.
600 ml/ min).
In patients with ESRD on haemodialysis, approximately 30% of the emtricitabine dose was recovered in dialysate over a 3 hour dialysis period which had been started within 1.5 hours of emtricitabine dosing (blood flow rate of 400 ml/ min and dialysate flow rate of approximately 600 ml/ min).
Emtricitabins farmakokinetik er ikke blevet undersøgt hos ikke- HBV- inficerede forsøgspersoner med forskellige grader af leverinsufficiens.
The pharmacokinetics of emtricitabine have not been studied in non-HBV infected subjects with varying degrees of hepatic insufficiency.
Generelt lignede emtricitabins farmakokinetik hos HBV- inficerede forsøgspersoner den hos raske forsøgspersoner og hos HIV- inficerede forsøgspersoner.
In general, emtricitabine pharmacokinetics in HBV infected subjects were similar to those in healthy subjects and in HIV infected subjects.
Alder, køn og etnisk oprindelse:
Age, gender and ethnicity:
Generelt ligner emtricitabins farmakokinetik hos børn og unge (fra 4 måneder til 18 år) den hos voksne.
In general, the pharmacokinetics of emtricitabine in infants, children and adolescents (aged 4 months up to 18 years) are similar to those seen in adults.
Det gennemsnitlige AUC hos 77 børn og unge, som modtog 6 mg/ kg emtricitabin en gang daglig som oral opløsning eller 200 mg emtricitabin som hårde kapsler en gang daglig, kunne sammenlignes med det gennemsnitlige AUC på 10, 0 µg· t/ ml hos 20 voksne, som fik 200 mg hårde kapsler en gang daglig.
10 The mean AUC in 77 infants, children and adolescents receiving 6 mg/ kg emtricitabine once daily as oral solution or 200 mg emtricitabine as hard capsules once daily was similar to the mean AUC of 10.0 µg·h/ ml in 20 adults receiving 200 mg hard capsules once daily.
De nyfødte fik to 4 dages behandlinger med emtricitabin oral opløsning mellem deres første leveuge og 3 måneders alderen med en dosis på 3 mg/ kg én gang dagligt.
In an open-label, non-comparative study, pharmacokinetic data were obtained from 20 neonates of HIV infected mothers who received two 4-day courses of emtricitabine oral solution between the first week of life and 3 months of age at a dose level of 3 mg/ kg once daily.
Denne dosis er det halve af den dosis, der er godkendt til børn på 4 måneder og ældre (6 mg/ kg).
This dose is half of that approved for infants aged 4 months and over (6 mg/ kg).
Den tilsyneladende totale clearance ved steady- state (CL/ F) steg med alderen i løbet af 3 - månedersperioden med et tilsvarende fald i AUC.
The apparent total body clearance at steady state (CL/ F) increased with age over the 3-month period with a corresponding decrease in AUC.
Emtricitabins eksponering i plasma (AUC) hos børn på op til 3 måneder, der fik behandling med 3 mg/ kg emtricitabin én gang dagligt, var på det samme niveau som det, der blev observeret ved brug af 6 mg/ kg daglig dosis hos HIV- inficerede voksne og børn, der var 4 måneder og ældre.
Plasma emtricitabine exposure (AUC) in infants up to 3 months of age who received 3 mg/ kg emtricitabine once daily was similar to that observed using 6 mg/ kg daily doses in HIV infected adults and children aged 4 months and over.
Der foreligger ikke farmakokinetiske data om ældre.
Pharmacokinetic data are not available in the elderly.
20% højere og det gennemsnitlige AUC var 16% højere hos kvinder i sammenligning med mænd, regnedes denne forskel ikke for at være klinisk signifikant.
Although the mean Cmax and Cmin were approximately 20% higher and mean AUC was 16% higher in females compared to males, this difference was not considered clinically significant.
Der er ikke blevet identificeret klinisk vigtige farmakokinetiske forskelle med hensyn til race.
No clinically important pharmacokinetic difference due to race has been identified.
De prækliniske data viser ingen særlig risiko for mennesker vurderet ud fra konventionelle undersøgelser af sikkerhedsfarmakologi, toksicitet efter gentagne doser, genotoksicitet og reproduktions - / udviklingstoksicitet.
Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity and reproductive/ developmental toxicity.
I langtidsundersøgelser af karcinogenicitet hos mus og rotter viste peroral indgift af emtricitabin intet karcinogent potentiale.
Emtricitabine did not show any carcinogenic potential in long-term oral carcinogenicity studies in mice and rats.
Kapslen indeholder:
Capsule contents:
Mikrokrystallinsk cellulose (E460) Crospovidon Magnesiumstearat (E572) Povidon (E1201)
Cellulose, microcrystalline (E460) Crospovidone Magnesium stearate (E572) Povidone (E1201)
11 Kapslens skal:
Capsule shell:
Gelatine Indigotin (E132) Titandioxid (E171)
Gelatin Indigotine (E132) Titanium dioxide (E171)
Trykfarven indeholder:
Printing ink containing:
Sort jernoxid (E172) Shellak (E904)
Black iron oxide (E172) Shellac (E904)
Hvid HD- polyethylen (HDPE) - flaske med børnesikret lukke, som indeholder 30 hårde kapsler.
White high-density polyethylene (HDPE) bottle fitted with a child-resistant closure, containing 30 hard capsules.
Blistre fremstillet af polychlortrifluorethylen (PCTFE) / polyethylen (PE) / polyvinylchlorid (PVC) / aluminium.
Blisters made of polychlorotrifluorethylene (PCTFE) / polyethylene (PE) / polyvinylchloride (PVC) / aluminium.
Gilead Sciences International Limited Cambridge CB21 6GT Storbritannien
Gilead Sciences International Limited Cambridge CB21 6GT United Kingdom
24. oktober 2003 Dato for seneste fornyelse:
24 October 2003 Date of last renewal:
Emtriva 10 mg/ ml oral opløsning
Emtriva 10 mg/ ml oral solution
Hver ml af Emtriva oral opløsning indeholder 10 mg emtricitabin.
Each ml of Emtriva oral solution contains 10 mg emtricitabine.
Hver dosis (24 ml) indeholder 36 mg methylparahydroxybenzoat (E218), 3, 6 mg propylparahydroxybenzoat (E216), 1, 2 mg Sunset yellow FCF (E110) og har et natriumindhold på 254 mg.
Each dose (24 ml) contains 36 mg methyl parahydroxybenzoate (E218), 3.6 mg propyl parahydroxybenzoate (E216), 1.2 mg Sunset Yellow (E110) and has a sodium content of 254 mg.
Emtriva 10 mg/ ml oral opløsning kan tages med eller uden mad.
Emtriva 10 mg/ ml oral solution may be taken with or without food.
6. 5).
A measuring cup is provided (see section 6.5).
Den anbefalede dosis af Emtriva 10 mg/ ml oral opløsning er 240 mg (24 ml) en gang daglig.
The recommended dose of Emtriva 10 mg/ ml oral solution is 240 mg (24 ml) once daily.
Børn og unge mennesker op til 18 år:
Infants, children and adolescents up to 18 years of age:
Den anbefalede dosis af Emtriva 10 mg/ ml oral opløsning er 6 mg/ kg op til maksimalt 240 mg (24 ml) en gang daglig.
The recommended dose of Emtriva 10 mg/ ml oral solution is 6 mg/ kg up to a maximum of 240 mg (24 ml) once daily.
Børn, som vejer mindst 33 kg, kan enten tage én 200 mg hård kapsel daglig, eller kan tage emtricitabin som oral opløsning op til maksimalt 240 mg en gang daglig.
Children who weigh at least 33 kg may either take one 200 mg hard capsule daily or may take emtricitabine as the oral solution up to a maximum of 240 mg once daily.
14 Der foreligger ingen dokumentation med hensyn til virkningen og kun meget begrænset dokumentation vedrørende sikkerheden af emtricitabin hos børn under 4 måneder.
Therefore Emtriva is not recommended for use in
Derfor bør Emtriva ikke anvendes hos børn yngre end 4 måneder.
13 those aged less than 4 months.
5. 2).
Due to a difference in the bioavailability of emtricitabine between the hard capsule and oral solution presentations, 240 mg emtricitabine administered as the oral solution (24 ml) should provide similar plasma levels to those observed after administration of one 200 mg emtricitabine hard capsule (see section 5.2).
Nedenstående skema giver daglige doser af Emtriva 10 mg/ ml oral opløsning i henhold til graden af nyreinsufficiens.
The table below provides daily doses of Emtriva 10 mg/ ml oral solution according to the degree of renal insufficiency.
Sikkerheden og effekten af disse doser er ikke blevet klinisk evalueret.
The safety and efficacy of these doses have not been clinically evaluated.
< 15 (svigt af nyrefunktion med behov for periodisk
< 15
hæmodialyse) * Anbefalet dosis af Emtriva 10 mg/ ml oral opløsning hver 24. time
(functionally anephric, requiring intermittent haemodialysis)* Recommended dose of Emtriva 10 mg/ ml oral solution every 24 hours
15 4. 3 Kontraindikationer
14 4.3 Contraindications
Sikkerheden og effekten af de i punkt 4. 2. anførte reducerede doser er baseret på farmakokinetiske date og modellering ved en enkelt dosis og er ikke blevet klinisk evalueret.
The safety and efficacy of the reduced doses provided in section 4.2 are based on single dose pharmacokinetic data and modelling and have not been clinically evaluated.
4. 2 og 5. 2).
Therefore, clinical response to treatment and renal function should be closely monitored in patients treated with a reduced dose of emtricitabine (see sections 4.2 and 5.2).
16 Patienter med øget risiko bør følges nøje.
15 Patients at increased risk should be followed closely.
Lipodystrophia:
Lipodystrophy:
De langsigtede konsekvenser af disse hændelser er p. t. ikke kendte.
The long-term consequences of these events are currently unknown.
Hos HIV- inficerede patienter med svær immuninsufficiens kan der ved påbegyndelse af antiretroviral kombinationsbehandling (CART) opstå en inflammatorisk reaktion på
In HIV infected patients with severe immune deficiency at the time of institution of combination antiretroviral therapy (CART), an inflammatory reaction to asymptomatic or residual opportunistic pathogens may arise and cause serious clinical conditions, or aggravation of symptoms.
Relevante eksempler er cytomegalovirus retinitis, generaliserede og/ eller fokale mycobakterielle infektioner og pneumocystis carinii pneumoni.
Any inflammatory symptoms
Alle inflammatoriske symptomer bør vurderes og behandling påbegyndes efter behov.
16 should be evaluated and treatment instituted when necessary.
Emtriva, oral opløsning, indeholder også methylparahydroxybenzoat (E218) og propylparahydroxybenzoat (E216), som ligeledes kan give allergiske reaktioner (muligvis forsinkede).
Emtriva oral solution contains Sunset Yellow (E110) which may cause allergic reactions, methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216) which may cause allergic reactions (possibly delayed).
Dette lægemiddel indeholder 254 mg natrium pr. dosis, hvilket der skal tages hensyn til, hvis patienter er på saltfattig diæt.
This medicinal product contains 254 mg of sodium per dose which should be taken into consideration by patients on a controlled sodium diet.
18 For at undgå overførsel af HIV anbefales det, at HIV- inficerede kvinder under ingen omstændigheder ammer deres børn.
It is recommended that HIV infected women do not breast-feed their infants under any circumstances in order to avoid transmission of HIV.
Der er ikke foretaget undersøgelser af virkningen på evnen til at føre motorkøretøj eller betjene maskiner.
However,
Patienter bør dog underrettes om, at svimmelhed er blevet indberettet som en bivirkning under behandling med emtricitabin.
17 patients should be informed that dizziness has been reported during treatment with emtricitabine.
Bivirkningerne med mistænkt (eller i det mindste en mulig) forbindelse med behandlingen af voksne er anført nedenfor efter legemssystemorganklasse og absolut hyppighed.
The adverse reactions with suspected (at least possible) relationship to treatment in adults are listed below by body system organ class and absolute frequency.
19 Almene symptomer og reaktioner på administrationsstedet:
General disorders and administration site conditions:
Profilen af bivirkninger hos patienter, som samtidig er inficerede med HBV, ligner den, der observeres hos patienter, som er inficerede med HIV, men ikke samtidig er inficerede med HBV.
The adverse reaction profile in patients co-infected with HBV is similar to that observed in patients
Som det kunne forventes hos denne patientpopulation, indtrådte stigninger i ASAT og ALAT dog hyppigere end i den generelle HIV- inficerede population.
However, as would be expected in this patient population, elevations in AST and ALT occurred more frequently than in the general HIV infected population.
20 Emtricitabin udviste ikke cytotoksicitet over for mononukleære celler i perifert blod (PBMC' er), etablerede lymfocyt - og monocyt- makrofagcellelinier eller knoglemarvsstamceller in vitro.
Emtricitabine did not exhibit cytotoxicity to peripheral blood mononuclear cells (PBMCs), established lymphocyte and monocyte-macrophage cell lines or bone marrow progenitor cells in vitro.
Ved afprøvning for aktivitet mod laboratoriestammer af HBV lå koncentrationen af emtricitabin for 50% hæmning (IC50) inden for området 0, 01- 0, 04 µmol/ l.
19 When tested for activity against laboratory strains of HBV, the 50% inhibitory concentration (IC50) value for emtricitabine was in the range of 0.01 to 0.04 µmol/ l.
Emtricitabin- resistente virus var krydsresistente over for lamivudin, men beholdt følsomhed over for andre nukleosid reverse transkriptasehæmmere (Nucleoside Reverse Transcriptase Inhibitors, NRTIs) (zidovudin, stavudin, tenofovir, abacavir, didanosin og zalcitabin), alle non- nukleoside reverse transkriptasehæmmere (Non- Nucleoside Reverse Transcriptase Inhibitors, NNRTIs) og alle proteasehæmmere (Protease Inhibitors, PIs).
Emtricitabine-resistant viruses were cross-resistant to lamivudine, but retained sensitivity to other nucleoside reverse transcriptase inhibitors (NRTIs) (zidovudine, stavudine, tenofovir, abacavir, didanosine and zalcitabine), all non-nucleoside reverse transcriptase inhibitors (NNRTIs) and all protease inhibitors (PIs).
Virus, som var resistente over for zidovudin, zalcitabin, didanosin og NNRTIs, beholdt deres følsomhed over for emtricitabin (IC50=0, 002 µmol/ l- 0, 08 µmol/ l).
Viruses resistant to zidovudine, zalcitabine, didanosine and NNRTIs retained their sensitivity to emtricitabine (IC50=0.002 µmol/ l to 0.08 µmol/ l).
21 5. 2 Farmakokinetiske egenskaber
5.2 Pharmacokinetic properties
Den absolutte biotilgængelighed af emtricitabin fra Emtriva 200 mg hårde kapsler blev vurderet til at være 93%, og den absolutte biotilgængelighed fra Emtriva 10 mg/ ml oral opløsning blev vurderet til at være 75%.
The absolute bioavailability of emtricitabine from Emtriva 200 mg hard capsules was estimated to be 93% and the absolute bioavailability from Emtriva 10 mg/ ml oral solution was estimated to be 75%.
I en pilotundersøgelse med børn og en definitiv bioækvivalensundersøgelse med voksne viste Emtriva 10 mg/ ml oral opløsning sig at have ca.
In a pilot study in children and a definitive bioequivalence study in adults, the Emtriva 10 mg/ ml oral solution was shown to have approximately 80% of the bioavailability of the Emtriva 200 mg hard
80% af biotilgængeligheden af Emtriva 200 mg hårde kapsler.
20 capsules.
22 Intracellulær farmakokinetik:
Intracellular pharmacokinetics:
Den systemiske emtricitabineksponering (gennemsnit ± standardafvigelsen) steg fra 11, 8±2, 9 µg· t/ ml hos forsøgspersoner med normal nyrefunktion til 19, 9±1, 1, 25, 0±5, 7 og 34, 0±2, 1 µg· t/ ml hos patienter med henholdsvis mildt, moderat og svært nedsat nyrefunktion.
The systemic emtricitabine exposure (mean ± standard deviation) increased from 11.8±2.9 µg·h/ ml in subjects with normal renal function to 19.9±1.1, 25.0±5.7 and 34.0±2.1 µg·h/ ml, in patients with mild, moderate and severe renal impairment, respectively.
30% af emtricitabindosen genfundet i dialysat over en 3- timers dialyseperiode, som var blevet startet inden for 1, 5 time efter emtricitabindosering (blodgennemstrømningshastighed på 400 ml/ min og dialysatgennemstrømningshastighed på ca.
In patients with ESRD on haemodialysis, approximately 30% of the emtricitabine dose was recovered in dialysate over a 3 hour dialysis period which had been started within 1.5 hours of emtricitabine
600 ml/ min).
21 dosing (blood flow rate of 400 ml/ min and dialysate flow rate of approximately 600 ml/ min).
Det gennemsnitlige AUC hos 77 børn og unge, som modtog 6 mg/ kg emtricitabin en gang daglig som oral opløsning eller 200 mg emtricitabin som hårde kapsler en gang daglig, kunne sammenlignes med det gennemsnitlige AUC på 10, 0 µg· t/ ml hos 20 voksne, som fik 200 mg hårde kapsler en gang daglig.
The mean AUC in 77 infants, children and adolescents receiving 6 mg/ kg emtricitabine once daily as oral solution or 200 mg emtricitabine as hard capsules once daily was similar to the mean AUC of 10.0 µg·h/ ml in 20 adults receiving 200 mg hard capsules once daily.
Sukkervataroma Dinatriumedetat Saltsyre Methylparahydroxybenzoat (E218) Propylenglycol Propylparahydroxybenzoat (E216) Natriumhydroxid Monobasisk natriumfosfathydrat Sunset yellow FCF (E110) Renset vand Xylitol (E967)
Cotton candy flavouring Disodium edetate Hydrochloric acid Methyl parahydroxybenzoate (E218) Propylene glycol Propyl parahydroxybenzoate (E216) Sodium hydroxide Sodium phosphate monobasic hydrate Sunset yellow (E110) Purified water Xylitol (E967)
6. 3 Opbevaringstid
22 6.3 Shelf life
Efter første åbning:
After first opening:
45 dage.
45 days.
Pakningen indeholder også et 30 ml målebæger af polypropylen med 1, 0 ml gradinddelinger.
The pack also contains a 30 ml polypropylene measuring cup with 1.0 ml graduations.
Patienter skal oplyses om, at al opløsning, der er tilbage i flasken 45 dage efter åbningen, skal kasseres i henhold til lokale retningslinjer eller leveres tilbage til apoteket.
Patients should be instructed that any solution left in the bottle 45 days after opening should be discarded according to local requirements or returned to the pharmacy.
25 BILAG II
23 ANNEX II
Gilead Science Limited Unit 13 Stillorgan Industrial Park Blackrock County Dublin Irland
Gilead Science Limited Unit 13 Stillorgan Industrial Park Blackrock County Dublin Ireland
I henhold til CHMP Guideline for Risk Management for lægemidler til human brug bør den opdaterede Risk Management Plan (RMP) indsendes samtidigt med den førstkommende PSUR (Periodic Safety Update Report).
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).
Desuden bør en opdateret RMP indsendes • når ny information modtages, som kan have indflydelse på den aktuelle sikkerhedsspecifikation, plan for bivirkningsovervågning eller tiltag til risikominimering • senest 60 dage efter, at en vigtig milepæl (bivirkningsovervågning eller risikominimering) er nået • efter krav fra EMEA.
In addition, an updated RMP should be submitted • When new information is received that may impact on the current Safety Specification, Pharmacovigilance Plan or risk minimisation activities • Within 60 days of an important (pharmacovigilance or risk minimisation) milestone being reached • At the request of the EMEA
PSURer
PSURs:
Indehaveren af markedsføringstilladelsen skal indsende periodiske, opdaterede sikkerhedsindberetninger (PSUR) hvert år.
The Marketing Authorisation Holder will submit PSUR’ s on an annual basis.
27 BILAG III
25 ANNEX III
29 MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE OG PÅ DEN INDRE EMBALLAGE
27 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
Gilead Sciences Intl Ltd Cambridge CB21 6GT Storbritannien
Gilead Sciences Intl Ltd Cambridge CB21 6GT United Kingdom
31 MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE OG PÅ DEN INDRE EMBALLAGE
29 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
33 MINDSTEKRAV TIL MÆRKNING PÅ BLISTERKORT ELLER BLISTERSTRIPS
31 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
34 MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE OG PÅ DEN INDRE EMBALLAGE
32 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
Emtriva 10 mg/ ml oral opløsning Emtricitabin
Emtriva 10 mg/ ml oral solution Emtricitabine
Hver ml indeholder 10 mg emtricitabin.
Each ml contains 10 mg emtricitabine.
Indeholder E110, E216, E218 og natrium.
Contains E110, E216, E218, and sodium.
Se indlægssedlen for at få yderligere information.
See leaflet for further information.
Opløsningen skal anvendes inden 45 dage.
After opening: the solution should be used within 45 days.