natgillin/translations-raw huggingface dataset:
Hverken emtricitabin eller tenofovir hæmmede lægemiddelmetabolismen in vitro ved hjælp af nogle af de større humane CYP450- isoformer, der er involveret i lægemiddelbiotransformationen.
Neither emtricitabine nor tenofovir inhibited in vitro drug metabolism mediated by any of the major human CYP450 isoforms involved in drug biotransformation.
Heller ikke emtricitabin hæmmede uridin 5 '- diphosphoglucuronyltransferase, det enzym der er ansvarligt for glucuronidering.
Also, emtricitabine did not inhibit uridine 5'-diphosphoglucuronyl transferase, the enzyme responsible for glucuronidation.
Efavirenz har en forholdsvis lang terminal halveringstid på mindst 52 timer efter enkeltdoser (se også data fra bioekvivalensundersøgelsen beskrevet ovenfor) og 40- 55 timer efter multiple doser.
Elimination: efavirenz has a relatively long terminal half-life of at least 52 hours after single doses (see also data from bioequivalence study described above) and 40 to 55 hours after multiple doses.
14- 34% af en isotopmærket efavirenzdosis blev genfundet i urinen, og mindre end 1% af dosis blev udskilt i urinen som uomdannet efavirenz.
Approximately 14 to 34% of a radiolabelled dose of efavirenz was recovered in the urine and less than 1% of the dose was excreted in urine as unchanged efavirenz.
10 timer.
Following oral administration, the elimination half-life of emtricitabine is approximately 10 hours.
86%) og fæces (ca.
Emtricitabine is primarily excreted by the kidneys with complete recovery of the dose achieved in urine (approximately 86%) and faeces (approximately 14%).
Emtricitabins systemiske clearance var i gennemsnit 307 ml/ min.
The systemic clearance of emtricitabine averaged 307 ml/ min.
12- 18 timer.
Following oral administration, the elimination half-life of tenofovir is approximately 12 to 18 hours.
70- 80% af dosen udskilles uomdannet i urinen efter intravenøs administration.
Tenofovir is primarily excreted by the kidney by both filtration and an active tubular transport system with approximately 70 to 80% of the dose excreted unchanged in urine following intravenous administration.
307 ml/ min.
The apparent clearance of tenofovir averaged approximately 307 ml/ min.
Renal clearance er beregnet til at være ca.
Renal
210 ml/ min, hvilket er over den glomerulære filtrationshastighed.
30 clearance has been estimated to be approximately 210 ml/ min, which is in excess of the glomerular filtration rate.
Farmakokinetikken for emtricitabin og tenofovir er den samme for mandlige og kvindelige patienter.
Age, gender and ethnicity: the pharmacokinetics of emtricitabine and tenofovir are similar in male and female patients.
Selvom begrænsede data tyder på, at kvindelige patienter samt patienter fra Asien og Stillehavsøerne har højere påvirkningsgrad over for efavirenz, synes deres tolerabilitet af efavirenz ikke at være mindre.
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.
Der er ikke udført farmakokinetiske undersøgelser med efavirenz, emtricitabin eller tenofovir hos ældre (over 65 år).
Pharmacokinetic studies have not been performed with efavirenz, emtricitabine or tenofovir in the elderly (over 65 years).
4. 2).
Pharmacokinetic studies with Atripla have not been performed in infants and children (see section 4.2).
Farmakokinetikken af efavirenz, emtricitabin og tenofovirdisoproxilfumarat efter samtidig administration af de enkelte lægemiddelformer eller som Atripla er ikke blevet undersøgt hos HIV- inficerede patienter med nyreinsufficiens.
Renal impairment: the pharmacokinetics of efavirenz, emtricitabine and tenofovir disoproxil fumarate after co-administration of the separate pharmaceutical forms or as Atripla have not been studied in HIV infected patients with renal impairment.
De farmakokinetiske parametre blev fastslået efter administration af enkeltdoser af de individuelle lægemidler emtricitabin 200 mg eller tenofovirdisoproxil 245 mg til ikke- HIV- inficerede patienter med varierende grader af nyreinsufficiens.
Pharmacokinetic parameters were determined following administration of single doses of the individual preparations of emtricitabine 200 mg or tenofovir disoproxil 245 mg to non-HIV infected patients with varying degrees of renal impairment.
Graden af nyreinsufficiens blev defineret i henhold til baseline kreatininclearance (normal nyrefunktion ved kreatininclearance > 80 ml/ min; mild insufficiens ved kreatininclearance = 50- 79 ml/ min; moderat insufficiens ved kreatininclearance = 30- 49 ml/ min og svær insufficiens ved kreatininclearance = 10- 29 ml/ min).
The degree of renal impairment was defined according to baseline creatinine clearance (normal renal function when creatinine clearance > 80 ml/ min; mild impairment with creatinine clearance=50 to 79 ml/ min; moderate impairment with creatinine clearance=30 to 49 ml/ min and severe impairment with creatinine clearance=10 to 29 ml/ min).
Gennemsnitlig (% CV) emtricitabin- eksponering øgedes fra 12 µg· t/ ml (25%) hos patienter med normal nyrefunktion til henholdsvis 20 µg· t/ ml (6%), 25 µg· t/ ml (23%) og 34 µg· t/ ml (6%) hos patienter med mild, moderat og svær nyreinsufficiens.
The mean (%CV) emtricitabine exposure increased from 12 µg• h/ ml (25%) in subjects with normal renal function to 20 µg• h/ ml (6%), 25 µg• h/ ml (23%) and 34 µg• h/ ml (6%) in patients with mild, moderate and severe renal impairment, respectively.
Gennemsnitlig (% CV) tenofovir- eksponering øgedes fra 2. 185 ng· t/ ml (12%) hos patienter med normal nyrefunktion til henholdsvis 3. 064 ng· t/ ml (30%), 6. 009 ng· t/ ml (42%) og 15. 985 ng· t/ ml (45%) hos patienter med mild, moderat og svær nyreinsufficiens.
The mean (%CV) tenofovir exposure increased from 2,185 ng• h/ ml (12%) in patients with normal renal function, to 3,064 ng• h/ ml (30%), 6,009 ng• h/ ml (42%) and 15,985 ng• h/ ml (45%) in patients with mild, moderate and severe renal impairment, respectively.
Hos patienter med nyresygdom i slutstadiet (ESRD), hvor hæmodialyse var påkrævet, øgedes emtricitabin- eksponeringen mellem dialysebehandlingerne væsentligt i løbet af 72 timer til 53 µg· t/ ml (19%), og tenofovir- eksponeringen øgedes i løbet af 48 timer til 42. 857 ng· t/ ml (29%).
In patients with end-stage renal disease (ESRD) requiring haemodialysis, between dialysis drug exposures substantially increased over 72 hours to 53 µg• h/ ml (19%) of emtricitabine, and over 48 hours to 42,857 ng• h/ ml (29%) of tenofovir.
Efavirenz 'farmakokinetik er ikke undersøgt hos patienter med nyreinsufficiens.
The pharmacokinetics of efavirenz have not been studied in patients with renal impairment.
Dog udskilles mindre end 1% af en efavirenzdosis uændret i urinen, så indvirkningen af nyreinsufficiens på efavirenz - eksponeringen er sandsynligvis minimal.
However, less than 1% of an efavirenz dose is excreted unchanged in the urine, so the impact of renal impairment on exposure to efavirenz is likely to be minimal.
33 Atripla anbefales ikke til patienter med moderat eller svær nyreinsufficiens (kreatininclearance < 50 ml/ min).
Atripla is not recommended for patients with moderate or severe renal impairment (creatinine clearance < 50 ml/ min).
4. 2 og 4. 4).
Patients with moderate or severe renal impairment require dose interval adjustment of emtricitabine and tenofovir disoproxil fumarate that cannot be achieved with the combination tablet (see sections 4.2 and 4.4).
Atriplas farmakokinetik er ikke undersøgt hos HIV- inficerede patienter med leverinsufficiens.
Hepatic impairment: the pharmacokinetics of Atripla have not been studied in HIV infected patients with hepatic impairment.
4. 3 og 4. 4).
Atripla should be administered with caution to patients with mild-to-moderate liver disease (see sections 4.3 and 4.4).
4. 3).
Atripla must not be used in patients with severe hepatic impairment (see section 4.3).
Hos den ene patient med svær leverinsufficiens (CPT, grad C), der er blevet undersøgt, fordobledes efavirenz 'halveringstid, hvilket tyder på potentiale for en meget højere grad af akkumulering.
In the single patient studied with severe hepatic impairment (CPT, Grade C), half-life of efavirenz was doubled indicating a potential for a much greater degree of accumulation.
Emtricitabins farmakokinetik er ikke undersøgt hos ikke- HBV- inficerede patienter med varierende grader af leverinsufficiens.
31 The pharmacokinetics of emtricitabine have not been studied in non-HBV infected patients with varying degrees of hepatic insufficiency.
Generelt var emtricitabins farmakokinetik hos HBV- inficerede patienter den samme som hos raske forsøgspersoner og hos HIV- inficerede patienter.
In general, emtricitabine pharmacokinetics in HBV infected patients were similar to those in healthy subjects and in HIV infected patients.
En enkelt dosis på 300 mg tenofovirdisoproxilfumarat blev administreret til ikke- HIV- inficerede patienter med varierende grader af leverinsufficiens, som var defineret i henhold til CPT- klassifikationen.
A single 300 mg dose of tenofovir disoproxil fumarate was administered to non-HIV infected patients with varying degrees of hepatic impairment defined according to CPT classification.
Tenofovirs farmakokinetik ændredes ikke væsentligt hos forsøgspersoner med leverinsufficiens, hvilket tyder på, at dosisjustering af tenofovirdisoporxilfumarat ikke var nødvendig hos disse forsøgspersoner.
Tenofovir pharmacokinetics were not substantially altered in subjects with hepatic impairment suggesting that no dose adjustment of tenofovir disoproxil fumarate is required in these subjects.
Der er set misdannelser hos 3 ud af 20 fostre/ nyfødte fra efavirenzbehandlede cynomolgusaber, der fik indgivet en dosis, der resulterede i efavirenzkoncentrationer i plasma lig dem set hos mennesker.
Malformations were observed in 3 of 20 foetuses/ newborns from efavirenz-treated cynomolgus monkeys given doses resulting in plasma efavirenz concentrations similar to those seen in humans.
Anencefali og unilateral anophthalmia med sekundær forstørrelse af tungen sås hos ét foster, microphthalmia hos et andet foster og ganespalte hos et tredje foster.
Anencephaly and unilateral anophthalmia with secondary enlargement of the tongue were observed in one foetus, micro-ophthalmia was observed in another foetus, and cleft palate was observed in a third foetus.
Konventionelle reproduktive/ udviklingstoksiske undersøgelser med emtricitabin og tenofovirdisoproxilfumarat viste ingen særlig risiko for mennesker.
Conventional reproductive/ developmental toxicity studies with emtricitabine and tenofovir disoproxil fumarate revealed no special hazard for humans.
Karcinogenicitetsundersøgelser med brug af efavirenz har vist øget incidens af hepatiske og pulmonære tumorer hos hunmus, men ikke hos hanmus.
Carcinogenicity studies using efavirenz showed an increased incidence of hepatic and pulmonary tumours in female mice, but not in male mice.
Karcinogenicitetsundersøgelser med brug af efavirenz til hanmus samt han - og hunrotter var negative.
Carcinogenicity studies using efavirenz in male mice and in male and female rats were negative.
Selvom karcinogenicitetspotentialet hos mennesker ikke er kendt, antyder disse data, at de kliniske fordele ved efavirenz opvejer den mulige karcinogenicitet hos mennesker.
While the carcinogenic potential in humans is unknown, these data suggest that the clinical benefit of efavirenz outweighs the potential carcinogenic risk to humans.
I langtidsundersøgelser af karcinogenicitet hos rotter viste peroral indgift af tenofovirdisoproxilfumarat intet karcinogent potentiale.
Tenofovir disoproxil fumarate did not show any carcinogenic potential in a long-term oral carcinogenicity study in rats.
En langtidsundersøgelse af karcinogenicitet hos mus ved peroral indgift viste en lav forekomst af duodenaltumorer, hvilket synes at være relateret til høj lokal koncentration i mavetarmkanalen ved en dosis på 600 mg/ kg/ dag.
A long-term oral carcinogenicity study in mice showed a low incidence of duodenal tumours, considered likely related to high local concentrations in the gastrointestinal tract at a dose of 600 mg/ kg/ day.
Tumordannelsens mekanisme er usikker, men fundene har sandsynligvis ingen relevans for mennesker.
While the mechanism of tumour formation is uncertain, the findings are unlikely to be of relevance to humans.
Emtricitabin udviste ikke karcinogent potentiale i langtidsundersøgelser med rotter og mus.
Emtricitabine did not show any carcinogenic potential in long-term studies in rats and mice.
Efavirenz og emtricitabin var negative i konventionelle genotoksiske tests.
Efavirenz and emtricitabine were negative in conventional genotoxic assays.
Tenofovirdisoproxilfumarat var positiv i to ud af tre in vitro- genotoksicitetsundersøgelser men negativ i in vivo- test af kernelegeme.
Tenofovir disoproxil fumarate was positive in two out of three in vitro genotoxicity studies but negative in the in vivo micronucleus assay.
Kombinationen af emtricitabin og tenofovirdisoproxilfumarat var positiv i in vitro- muselymfomtesten med resultater, som var sammenlignelige med dem, der blev opnået for tenofovirdisoproxilfumarat alene.
The combination of emtricitabine and tenofovir disoproxil fumarate was positive in the in vitro mouse lymphoma assay, with comparable results to those obtained for tenofovir disoproxil fumarate alone.
Kombinationen af emtricitabin og tenofovirdisoproxilfumarat var negativ i den bakterielle tilbagemutationstest (Ames test).
The combination of emtricitabine and tenofovir disoproxil fumarate was negative in the bacterial reverse mutation assay (Ames assay).
2 gange højere end hos mennesker, der fik den anbefalede dosis.
Biliary hyperplasia was observed in cynomolgus monkeys given efavirenz for ≥ 1 year at a dose resulting in mean AUC values approximately 2-fold greater than those in humans given the recommended dose.
4. 4 og 4. 8).
Non-sustained convulsions were observed in some monkeys receiving efavirenz for ≥ 1 year, at doses yielding plasma AUC values 4- to 13-fold greater than those in humans given the recommended dose (see sections 4.4 and 4.8).
Prækliniske undersøgelser af tenofovirdisoproxilfumarat udført på rotter, hunde og aber afslørede knoglepåvirkning og et fald i serumphosphatkoncentrationen.
Preclinical studies of tenofovir disoproxil fumarate conducted in rats, dogs and monkeys revealed effects on bone and a decrease in serum phosphate concentration.
Fund ved undersøgelser af rotter og aber viste, at der var en stofrelateret reduktion i den intestinale absorption af phosphat med potentiel, sekundær reduktion af knoglemineraltætheden.
Findings in the rat and monkey studies indicated that there was a substance-related decrease in intestinal absorption of phosphate with potential secondary reduction in bone mineral density.
Mekanismerne bag disse toksiciteter forstås ikke til fulde.
The mechanisms of these toxicities are not completely understood.
I en undersøgelse af en måneds varighed med hunde, hvor kombinationen af emtricitabin og tenofovirdisoproxilfumarat blev anvendt, sås ingen forværring af toksikologiske virkninger sammenlignet med de enkelte komponenter.
32 A one month dog study using the combination of emtricitabine and tenofovir disoproxil fumarate found no exacerbation of toxicological effects compared to the separate components.
Croscarmellosenatrium Hydroxypropylcellulose Magnesiumstearat Mikrokrystallinsk cellulose Natriumlaurilsulfat
Croscarmellose sodium Hydroxypropylcellulose Magnesium stearate Microcrystalline cellulose Sodium laurilsulfate
Overtræk:
Film-coating:
Sort jernoxid Rød jernoxid Macrogol 3350 Poly( vinylalkohol) Talcum Titandioxid
Iron oxide black Iron oxide red Macrogol 3350 Poly(vinyl alcohol) Talc Titanium dioxide
Højdensitetspolyethylen (HDPE) - flaske med børnesikret polypropylenlåg indeholdende 30 filmovertrukne tabletter og silicagel- tørremiddel.
High density polyethylene (HDPE) bottle with a polypropylene child-resistant closure containing 30 film-coated tablets and silica gel desiccant.
35 Fås i pakninger, der indeholder 1 flaske med 30 filmovertrukne tabletter eller 3 flasker med 30 filmovertrukne tabletter.
The following pack sizes are available: outer cartons containing 1 x 30 film-coated tablet and 3 x 30 film-coated tablet bottles.
Dublin Irland
Dublin Ireland
Yderligere information om dette lægemiddel er tilgængelig på Det europæiske Lægemiddelagenturs (EMEAs) hjemmeside http: // www. emea. europa. eu /
Detailed information on this medicinal product is available on the website of the European Medicines Agency (EMEA) http: / /www. emea. europa. eu/.
36 BILAG II
34 ANNEX II
Cork Irland
Cork Ireland
Lægemidlet må kun udleveres efter begrænset recept (jf. bilag I; Produktresumé, pkt.
Medicinal product subject to restricted medical prescription (See Annex I:
Indehaveren af markedsføringstilladelsen skal sikre, at yderligere tiltag til risikominimering af betænkelighederne vedrørende renal sikkerhed, der er relateret til tenofovirdisoproxilfumarat, et af de aktive indholdsstoffer i Atripla, implementeres for denne faste kombination, ligesom det er tilfældet for alle lægemidler, der indeholder tenofovirdisoproxilfumarat.
The MAH shall ensure that additional risk minimisation activities to address the renal safety concerns related to tenofovir disoproxil fumarate, one of the active substances contained in Atripla, are being implemented for this fixed combination like for all medicinal products containing tenofovir disoproxil fumarate.
Bivirkningsovervågning
Pharmacovigilance system
Indehaveren af markedsføringstilladelsen skal sikre, at systemet for bivirkningsovervågning, som beskrevet i version 2. 0 (28/ 02/ 2008) og inkluderet i Type II- variationen (EMEA/ H/ C/ 000797/ II/ 0003), er på plads og fungerer, før og efter dette produkt er markedsført.
The MAH must ensure that the system of pharmacovigilance, as described in version 2.0 (28/ 02/ 2008) and included in the Type II variation (EMEA/ H/ C/ 000797/ II/ 0003) is in place and functioning before and whilst the product is on the market.
Risk Management Plan
Risk Management Plan
Som vedtaget i version 3 (februar 2008) af Risk Management Planen (RMP), som fremgår af den første PSUR, og alle følgende opdateringer af RMP, der er vedtaget af CHMP, forpligter indehaveren af markedsføringstilladelsen sig til at udføre undersøgelser og yderligere tiltag inden for bivirkningsovervågning, sådan som det i detaljer er beskrevet i planen for bivirkningsovervågning.
The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in version 3 (February 2008) of the Risk Management Plan (RMP) presented with the first PSUR and any subsequent updates of the RMP agreed by the CHMP.
I henhold til CHMP Guideline for Risk Management for lægemidler til human brug bør den opdaterede 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).
38 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.
36 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
39 BILAG III
37 ANNEX III
41 MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE OG PÅ DEN INDRE EMBALLAGE
39 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
Atripla 600 mg/ 200 mg/ 245 mg filmovertrukne tabletter efavirenz, emtricitabin og tenofovirdisoproxil
Atripla 600 mg/ 200 mg/ 245 mg film-coated tablets efavirenz, emtricitabine and tenofovir disoproxil
30 filmovertrukne tabletter 3 x 30 filmovertrukne tabletter.
30 film-coated tablets 3 x 30 film-coated tablets
EU/ 1/ 07/ 430/ 001 30 filmovertrukne tabletter EU/ 1/ 07/ 430/ 002 3 x 30 filmovertrukne tabletter
EU/ 1/ 07/ 430/ 001 30 film-coated tablets EU/ 1/ 07/ 430/ 002 3 x 30 film-coated tablets
- Lægen har ordineret Atripla til Dem personligt.
- This medicine has been prescribed for you.
Virkning og anvendelse 2.
What Atripla is and what it is used for 2.
Det skal De vide, før De begynder at tage Atripla 3.
Before you take Atripla 3.
Sådan skal De tage Atripla 4.
How to take Atripla 4.
Opbevaring 6.
How to store Atripla 6.
VIRKNING OG ANVENDELSE
WHAT ATRIPLA IS AND WHAT IT IS USED FOR
Atripla indeholder tre aktive stoffer, som anvendes til at behandle human immundefekt virus (HIV) - infektion:
Atripla contains three active substances that are used to treat human immunodeficiency virus (HIV) infection:
- Efavirenz er en ikke- nukleosid- revers transkriptase- hæmmer (NNRTI).
- Efavirenz is a non-nucleoside reverse transcriptase inhibitor (NNRTI)
- Emtricitabin er en nukleosid- revers transkriptase- hæmmer (NRTI).
- Emtricitabine is a nucleoside reverse transcriptase inhibitor (NRTI)
- Tenofovir er en nukleotid- revers transkriptase- hæmmer (NtRTI).
- Tenofovir is a nucleotide reverse transcriptase inhibitor (NtRTI)
Hver af disse stoffer, også kendt som antiretroviral medicin, virker ved at hæmme et enzym (revers transkriptase), som er nødvendigt for at virus kan formere sig.
Each of these active substances, also known as antiretroviral medicines, work by interfering with an enzyme (reverse transcriptase) that is essential for the virus to multiply.
Atripla er til behandling af Human Immundefekt Virus (HIV) - infektion hos voksne fra 18 år, som tidligere er blevet behandlet med anden antiretroviral medicin, og hvis HIV- 1- infektion har været under kontrol i mindst tre måneder.
Atripla is a treatment for Human Immunodeficiency Virus (HIV) infection in adults aged 18 and over who have previously been treated with other antiretroviral medicines and have their HIV-1 infection under control for at least three months.
Patienterne oplevetbehøver ikke at have være udsat for, at en tidligere HIV- behandling ikke har virket.
Patients must not have experienced failure of a previous HIV therapy.
DET SKAL DE VIDE, FØR DE BEGYNDER AT TAGE ATRIPLA
BEFORE YOU TAKE ATRIPLA
Tag ikke Atripla
Do not take Atripla
- hvis De er overfølsom (allergisk) over for efavirenz, emtricitabin, tenofovir,
- if you are allergic (hypersensitive) to efavirenz, emtricitabine, tenofovir, tenofovir disoproxil
tenofovirdisoproxilfumarat eller et af de øvrige indholdsstoffer, som er nævnt i slutningen af denne indlægsseddel.
fumarate, or any of the other ingredients of Atripla listed at the end of this leaflet.
- hvis De i øjeblikket tager et eller flere af følgende lægemidler:
- if you are currently taking any of the following medicines:
Astemizol eller terfenadin (mod høfeber eller andre allergier) Bepridil (mod hjertesygdom) Cisaprid (mod halsbrand) Ergotalkaloider (f. eks. ergotamin, dihydroergotamin, ergonovin og methylergonovin) (mod migræne og klyngehovedpine) 45
astemizole or terfenadine (used to treat hay fever or other allergies) bepridil (used to treat heart disease) cisapride (used to treat heartburn) ergot alkaloids (for example, ergotamine, dihydroergotamine, ergonovine, and methylergonovine) (used to treat migraines and cluster headaches)
Midazolam eller triazolam (sovemedicin) Pimozid (mod visse sindstilstande) Perikon (Hypericum perforatum) (urtemedicin mod depression og angst) Voriconazol (mod svampeinfektioner)
John’ s wort (Hypericum perforatum) (a herbal remedy used for depression and anxiety)
Vær ekstra forsigtig med at tage Atripla
Take special care with Atripla
- Kvinder bør ikke blive gravide under behandling med Atripla og i 12 uger derefter (se
- Women should not get pregnant during treatment with Atripla and for 12 weeks
Graviditet og amning).
thereafter (see Pregnancy and breast-feeding).