natgillin/translations-raw huggingface dataset:
H2- receptorantagonister.
Although not studied, similar results are expected with other H2-receptor antagonists.
samtidig administration med H2- receptorantagonist, givet som daglig enkeltdosis med mad.
ritonavir is required when co-administered with an H2-receptor antagonist, all as a single daily dose with food.
REYATAZ 300 mg/ ritonavir 100 mg én gang dagligt med mad, 2 timer før og mindst 10 timer efter administration af H2- receptorantagonis - ten.
REYATAZ 300 mg with ritonavir 100 mg once daily with food, 2 hours before and at least 10 hours following the administration of an H2-receptor antagonist.
Omeprazol 40 mg QD
Omeprazole 40 mg QD
0, 39 0, 44 0, 35 (morgen):
0.39 0.44 0.35 hr after
(0, 35; 0, 45) (0, 38; 0, 51) (0, 29; 0, 41) efter omeprazol
(0.35, 0.45) (0.38, 0.51) (0.29, 0.41) omeprazole
Omeprazol 20 mg QD (atazanavir 400 mg QD med ritonavir 100 mg QD)
Omeprazole 20 mg QD (atazanavir 400 mg QD with ritonavir 100 mg QD)
atazanavir ↓0, 70 * ↓0, 69 * ↓0, 69 * (morgen):
atazanavir (am):
1 time (0, 57; 0, 86) (0, 58; 0, 83) (0, 54; 0, 88) efter omeprazaol * Sammenligning med atazanavir 300 mg QD med ritonavir 100 mg QD
1 ↓ 0.70* ↓ 0.69* ↓ 0.69* hr after (0.57, 0.86) (0.58, 0.83) (0.54, 0.88) omeprazaole * When compared to atazanavir 300 mg QD with ritonavir 100 mg QD
Hvis kombinationen af REYATAZ / ritonavir og proton - pumpehæmmeren vurderes at være
combination of REYATAZ/ ritonavir with a proton pump inhibitor is judged unavoidable, close clinical monitoring is
ANTINEOPLASTISKE og IMMUNSUPPRIMERENDE MIDLER Antineoplastiske midler Irinotecan
ANTINEOPLASTICS AND IMMUNOSUPRESSANTS Antineoplastics Irinotecan
Hvis REYATAZ / ritonavir administreres
If REYATAZ/ ritonavir is co-administered with irinotecan, patients should be closely
Samtidigt administrerede
89 Co-administered medicinal
samtidig med irinotecan, bør patienten monitoreres tæt for irinotecan- relaterede bivirkninger.
monitored for adverse events related to irinotecan.
Immunsupprimerende midler Ciclosporin Tacrolimus Sirolimus KARDIOVASKULÆRE MIDLER Antiarytmika
Immunosuppressants Cyclosporin Tacrolimus Sirolimus CARDIOVASCULAR AGENTS Antiarrhythmics
CYP3A4- hæmning øges ved samtidig administration med REYATAZ/ ritonavir.
Concentrations of these immunosuppressants may be increased when co-administered with REYATAZ/ ritonavir due to CYP3A4 inhibition.
Amiodaron, Systemisk lidocain, Kinidin
Amiodarone, Systemic lidocaine, Quinidine
Koncentrationer af disse antiarytmika kan øges ved samtidig administration med REYATAZ/ ritonavir.
Concentrations of these antiarrhythmics may be increased when co-administered with REYATAZ/ ritonavir.
Interaktionsmekanismen for amiodaron eller systemisk lidocain/ atazanavir er CYP3A- hæmning.
The mechanism of amiodarone or systemic lidocaine/ atazanavir interaction is CYP3A inhibition.
Kinidin har et snævert terapeutisk indeks og er kontraindiceret på grund af risiko for CYP3A- hæmning med REYATAZ/ ritonavir.
Quinidine has a narrow therapeutic window and is contraindicated due to potential inhibition of CYP3A by REYATAZ/ ritonavir.
Calcium- antagonister Bepridil
Calcium channel blockers Bepridil
monitorering
needed and ECG monitoring.
CYP3A4- hæmning.
Serum concentrations of verapamil may be increased by REYATAZ/ ritonavir due to CYP3A4 inhibition.
Der bør udvises forsigtighed ved samtidig administration af verapamil og REYATAZ / ritonavir
Caution should be exercised when verapamil is co-administered with REYATAZ/ ritonavir.
Fluticasonpropionat intranasalt 50 µg, 4 gange dagligt i 7 dage (ritonavir 100 mg kapsler BID)
Fluticasone propionate intranasal 50 µg 4 times daily for 7 days (ritonavir 100 mg capsules BID)
Dosisreduktion af glukokortikoidet bør overvejes, og patienten
A dose reduction of the glucocorticoid should be considered with close monitoring of local and systemic effects or a switch to a glucocorticoid, which is not a substrate for CYP3A4 (eg, beclomethasone).
93
90
lægemidler (dosis i mg)
Co-administered medicinal products (dose in mg)
(90% KI) (90% KI) (90% KI)
Medicinal AUC Cmax Cmin product assessed (90% CI) (90% CI) (90% CI)
vedrørende samtidig administration
Recommendations concerning co-administration
Derudover kan det i tilfælde af seponering af glukokortikoidet, være nødvendigt med progressiv dosisreduktion over en længere periode.
Moreover, in case of withdrawal of glucocorticoids, progressive dose reduction may have to be performed over a longer period.
EREKTIL DYSFUNKTION PDE5- hæmmere Sildenafil
ERECTILE DYSUNCTION PDE5 Inhibitors Sildenafil
Sildenafil metaboliseres af CYP3A4.
Sildenafil is metabolised by CYP3A4.
Samtidig administration med REYATAZ/ ritonavir kan medføre øgede koncentrationer af sildenafil og stigninger i sildenafil- relaterede bivirkninger, inklusive hypotension, synsforstyrrelser og priapisme.
Co-administration with REYATAZ/ ritonavir may result in increased concentrations of sildenafil and an increase in sildenafil-associated adverse events, including hypotension, visual changes, and priapism.
Interaktionsmekanismen for sildenafil/ atazanavir er CYP3A4- hæmning.
The mechanism of the sildenafil/ atazanavir interaction is CYP3A4 inhibition.
Patienterne bør advares om disse mulige bivirkninger.
Patients should be warned about these possible side effects.
NATURMEDICIN
HERBAL PRODUCTS
Prikbladet perikum (Hypericum perforatum):
John’ s wort (Hypericum perforatum):
Samtidig brug af prikbladet perikum og REYATAZ/ ritonavir kan forventes at medføre signifikant fald i plasma- niveauet af atazanavir.
John's wort with REYATAZ/ ritonavir may be expected to result in significant reduction in plasma levels of atazanavir.
Denne effekt kan skyldes en induktion af CYP3A4.
This effect may be due to an induction of CYP3A4.
4. 3).
There is a risk of loss of therapeutic effect and development of resistance (see section 4.3).
Samtidig administration af REYATAZ / ritonavir og produkter indeholdende prikbladet perikum er kontraindiceret.
John's wort is contraindicated.
Ethinyløstradiol 35 μg + norethindron (atazanavir 400
HORMONAL CONTRACEPTIVES Ethinyloestradiol 35 μ g + norethindrone (atazanavir 400
norbuprenorphin
Concentrations of atazanavir were not significantly affected.
↑1, 61
Methadone, stable maintenance dose (atazanavir 400 mg QD)
↑2, 01
Given that low dose ritonavir (100 mg twice daily) has been shown to have no significant effect on methadone concentrations, no interaction is
klinisk monitorering for sedering og
No dosage adjustment is necessary if methadone is
94
91
kognitiv påvirkning.
SEDATIVES Benzodiazepines
Da lav dosis af ritonavir (100 mg BID) er vist ikke at have betydelig effekt på metadon- koncentrationen, forventes på baggrund af disse data ingen interaktion ved samtidig administration af metadon og REYATAZ/ ritonavir.
expected if methadone is co-administered with REYATAZ and ritonavir, based on these data.
Dosisjustering er ikke nødvendig ved samtidig administration af metadon og REYATAZ / ritonavir.
coadministered with REYATAZ and ritonavir.
Der er ikke gennemført interaktionsstudier af samtidig administration af REYATAZ/ ritonavir og benzodiazepiner.
No drug interaction study has been performed for the co-administration of REYATAZ/ ritonavir with benzodiazepines.
På baggrund af data for andre CYP3A4- hæmmere, forventes plasma- koncentrationen af midazolam at være betydeligt højere hvis midazolam administreres oralt.
Based on data for other CYP3A4 inhibitors, plasma concentrations of midazolam are expected to be significantly higher when midazolam is given orally.
Data vedrørende samtidig brug af parenteral midazolam og andre proteasehæmmere tyder på en mulig 3- 4 gange stigning i plasma - niveauet af midazolam.
Data from concomitant use of parenteral midazolam with other protease inhibitors suggest a possible 3-4 fold increase in midazolam plasma levels.
4. 3), og der bør udvises forsigtighed ved samtidig administration af REYATAZ / ritonavir og parenteral midazolam.
REYATAZ/ ritonavir should not be co-administered with triazolam or orally administered midazolam (see section 4.3), whereas caution should be used with co-administration of REYATAZ/ ritonavir and parenteral midazolam.
Hvis REYATAZ administreres sammen med parenteral midazolam, bør dette foregå på en intensiv afdeling eller tilsvarende afdeling, som sikrer tæt klinisk monitorering og relevant medicinsk behandling i tilfælde af respiratorisk depression og/ eller forlænget sedering.
If REYATAZ is co-administered with parenteral midazolam, it should be done in an intensive care unit (ICU) or similar setting which ensures close clinical monitoring and appropriate medical management in case of respiratory depression and/ or prolonged sedation.
95 4. 7 Virkninger på evnen til at føre motorkøretøj eller betjene maskiner
4.7 Effects on ability to drive and use machines
4. 8 Bivirkninger
92 4.8 Undesirable effects
Blandt patienter, der fik 300 mg REYATAZ med 100 mg ritonavir, var frekvensen af gulsot 17%.
Among patients receiving REYATAZ 300 mg with ritonavir 100 mg, the frequency of jaundice was 17%.
almindelige: udslæt ikke almindelige: urticaria, alopeci, pruritus sjældne: vesiculobulløst udslæt, eksem, vasodilatation
common: rash; uncommon: urticaria, alopecia, pruritus;
Andre markante, kliniske laboratoriemæssige abnormaliteter (grad 3 eller 4) rapporteret hos ≥ 2% af patienterne, der fik regimer indeholdende REYATAZ og én eller flere NRTIer omfattede: forhøjet kreatinkinase (7%), forhøjet alaninaminotransferase/ serum- glutamin- pyrudrue transaminase (ALAT/ SGPT) (4%), lav neutrofiltælling (4%), forhøjet aspartataminotransferase/ serum- glutamin - oxalsyretransaminase (ASAT/ SGOT) (3%) og forhøjet lipase (2%).
Other marked clinical laboratory abnormalities (Grade 3 or 4) reported in ≥ 2% of patients receiving regimens containing REYATAZ and one or more NRTIs included: elevated creatine kinase (7%), elevated alanine aminotransferase/ serum glutamic-pyruvic transaminase (ALT/ SGPT) (4%), low neutrophils (4%), elevated aspartate aminotransferase/ serum glutamic-oxaloacetic transaminase (AST/ SGOT) (3%), and elevated lipase (2%).
97 Én procent af patienterne behandlet med REYATAZ oplevede samtidig grad 3- 4 ALAT/ ASAT og grad 3- 4 forhøjelser af total bilirubin.
One percent of patients treated with REYATAZ experienced concurrent Grade 3-4 ALT/ AST and Grade 3-4 total bilirubin elevations.
Patienter med samtidig hepatitis B - og/ eller hepatitis C- virusinfektion Blandt 1. 151 patienter, der fik 400 mg atazanavir én gang dagligt, var 177 patienter samtidig inficeret med kronisk hepatitis B eller C, og blandt 655 patienter, der fik 300 mg atazanavir én gang dagligt med 100 mg ritonavir én gang dagligt, var 97 samtidig inficeret med kronisk hepatitis B eller C.
Co-infected
Samtidigt inficerede patienter havde større sandsynlighed for forhøjede levertransaminaser ved baseline end de, der ikke havde kronisk viral hepatitis.
94 patients were more likely to have baseline hepatic transaminase elevations than those without chronic viral hepatitis.
4. 4 og 4. 8).
At high doses that lead to high drug exposures, jaundice due to indirect (unconjugated) hyperbilirubinaemia (without associated liver function test changes) or PR interval prolongations may be observed (see sections 4.4 and 4.8).
En
Resistance Antiretroviral treatment naive patients In antiretroviral treatment naive patients, the I50L substitution, sometimes in combination with an A71V change, is the signature resistance substitution for atazanavir.
98 atazanavir resistensfænotype udtrykkes i alle gensplejsede virale kloner indeholdende I50L - substitutionen, i en lang række genetiske baggrunde.
An atazanavir resistance phenotype is expressed in all recombinant viral clones containing the I50L substitution in a variety of genetic backgrounds.
Patienter der tidligere har været i antiretroviral behandling Hos antiretroviralt behandlingserfarne patienter blev 100 isolater fra patienter angivet som virologisk svigt under behandling, der omfattede enten atazanavir, atazanavir + ritonavir eller atazanavir + saquinavir og blev fastsat til at have udviklet resistens over for atazanavir,.
95 Antiretroviral treatment experienced patients In antiretroviral treatment experienced patients, 100 isolates from patients designated as virological failures on therapy that included either atazanavir, atazanavir + ritonavir, or atazanavir + saquinavir were determined to have developed resistance to atazanavir.
Ud af de 60 isolater fra patienter behandlet med enten atazanavir eller atazanavir + ritonavir viste 18 (30%) I50L- fænotypen tidligere beskrevet hos patienter, der ikke tidligere havde været behandlet.
Of the 60 isolates from patients treated with either atazanavir or atazanavir + ritonavir, 18 (30%) displayed the I50L phenotype previously described in naive patients.
Krydsresistens in vitro for vira, der er resistente over for andre proteasehæmmere Følsomhed over for atazanavir er evalueret i 943 kliniske isolater fra patienter, der ikke tidligere havde været behandlet med atazanavir og som viste en lang række genotype - og fænotypemønstre.
Atazanavir susceptibility was evaluated in 943 clinical isolates from patients without prior atazanavir exposure and exhibited a wide array of genotypic and phenotypic patterns.
In vitro sås tydelig tendens til nedsat følsomhed over for atazanavir, da isolaterne viste høje resistensniveauer over for flere proteasehæmmere.
In vitro, there was a clear trend toward decreased susceptibility to atazanavir as isolates exhibited high resistance levels to multiple protease inhibitors.
Kliniske resultater Patienter der ikke tidligere har været i antiretroviral behandling Studie 138 er en international, randomiseret, åben, prospektiv multicenter- undersøgelse med 883 ikke tidligere antiretroviralt behandlede patienter, der sammenligner REYATAZ/ ritonavir (300 mg/ 100 mg én gang dagligt) med lopinavir/ ritonavir (400 mg/ 100 mg 2 gange dagligt), hver i kombination med en fast dosis tenofovir/ emtricitabin (300 mg/ 200 mg tabletter én gang dagligt).
Clinical results In antiretroviral naive patients Study 138 is an international randomised, open-label, multicenter, prospective trial of 883 antiretroviral treatment naïve patients comparing REYATAZ/ ritonavir (300 mg/ 100 mg once daily) to lopinavir/ ritonavir (400 mg/ 100 mg twice daily), each in combination with fixed dose tenofovir/ emtricitabine (300 mg/ 200 mg tablets once daily).
99 Tabel 2:
Table 2:
Effektresultater ved Uge 48 (Studie 138) for CVR (NC=F) analysen
Efficacy Outcomes at Week 48 (Study 138) for the CVR (NC=F) analysis REYATAZ/ ritonavira lopinavir/ ritonavirb (300 mg/ 100 mg (400 mg/ 100 mg once daily) twice daily)
n=440 n=443
n=440 n=443
CD4- tal
96 CD4 count
Andelen af patienter med HIV RNA < 400 kopier/ ml i REYATAZ + ritonavir- armen og lopinavir + ritonavir- armen var henholdsvis 53% 54% ved ITT- analyse (intent- to- treat), hvor manglende værdier betragtedes som
The proportions of patients with HIV RNA < 400 copies/ ml in the REYATAZ + ritonavir arm and the lopinavir + ritonavir arm were 53% and 54%, respectively, by intent-to-treat analysis, with missing values considered as failures.
Andelen af patienter med HIV RNA < 50 kopier/ ml i REYATAZ + ritonavir- armen og lopinavir + ritonavir- armen var henholdsvis 36% og 42%.
The proportions of patients with HIV RNA < 50 copies/ ml in the REYATAZ + ritonavir arm and the lopinavir + ritonavir arm were 36% and 42%, respectively.
Andelen af patienter med HIV RNA < 400 kopier/ ml (< 50 kopier/ ml) for REYATAZ + ritonavir var 43% (32%) og 46% (35%) for lopinavir + ritonavir.
97 lopinavir + ritonavir were 46% (35%).
Ved AT- analyse, hvor manglende værdier blev ekskluderede, var andelen af patienter med HIV RNA < 400 kopier/ ml (< 50 kopier/ ml) for REYATAZ+ ritonavir 84% (72%) og for lopinavir + ritonavir 82% (72%).
By as-treated analysis, excluding missing values, the proportions of patients with HIV RNA < 400 copies/ ml (< 50 copies/ ml) for REYATAZ + ritonavir were 84% (72%) and for lopinavir + ritonavir were 82% (72%).
Samtidig indtag af enkeltdosis REYATAZ 300 mg og ritonavir 100 mg og et let måltid medførte en stigning i AUC på 33% og en stigning i såvel Cmax som 24- timerskoncentrationen af atazanavir på 40% i forhold til i fastende tilstand.
Co-administration of a single 300 mg dose of REYATAZ and 100 mg dose of ritonavir with a light meal resulted in a 33% increase in the AUC and a 40% increase in both the Cmax and the 24-hour concentration of atazanavir relative to the fasting state.
I en flerdosis - undersøgelse med HIV- inficerede patienter der fik 400 mg atazanavir én gang dagligt med et let måltid i 12 uger, kunne atazanavir påvises i cerebrospinalvæsken og sæd.
In a multiple-dose study in HIV-infected patients dosed with 400 mg of atazanavir once daily with a light meal for 12 weeks, atazanavir was detected in the cerebrospinal fluid and semen.
Efter en enkelt dosis på 400 mg 14C- atazanavir, blev henholdsvis 79% og 13% af den totale radioaktivitet genfundet i fæces og urin.
98 Elimination: following a single 400-mg dose of 14C-atazanavir, 79% and 13% of the total radioactivity was recovered in the faeces and urine, respectively.
4. 2, 4. 3 og 4. 4).
Concentrations of atazanavir with or without ritonavir are expected to be increased in patients with moderately or severely impaired hepatic function (see sections 4.2, 4.3 and 4.4).
102 Den klonede, humane kardielle kaliumkanal, hERG, blev hæmmet med 15% i in vitro- undersøgelser ved en koncentration (30 μM) af atazanavir svarende til 30 gange den frie lægemiddelkoncentration ved Cmax hos mennesker.
During in vitro studies, cloned human cardiac potassium channel (hERG), was inhibited by 15% at a concentration (30 μ M) of atazanavir corresponding to 30-fold the free drug concentration at Cmax in humans.
4. 9).
The potential for PR prolongation should be considered in cases of overdose (see section 4.9).
Der sås hos drægtige kaniner omfattende læsioner i mave og tarm hos døde eller moribunde hunner ved maternelle doser 2 og 4 gange den højeste dosis administreret i den endelige fosterudviklingsundersøgelse.
In pregnant rabbits, gross lesions of the stomach and intestines were observed in dead or moribund does at maternal doses 2 and 4 times the highest dose administered in the definitive
I den præ - og postnatale udviklingsvurdering hos rotter, frembragte atazanavir en forbigående reduktion i legemsvægten hos afkommet ved en maternel toksisk dosis.
In the pre- and postnatal development assessment in rats, atazanavir produced a transient reduction in body weight in the offspring at a maternally toxic dose.
Aspartam (E951) Saccharose Appelsin- vaniljesmag omfattende:
Aspartame (E951) Sucrose Orange-vanilla flavour including:
Modificeret fødevarestivelse Dextrose Butylhydroxytoluen (E321)
Modified food starch Dextrose Butylhydroxytoluene (E321)
2 år Efter åbning:
2 years After opening:
103 6. 4 Særlige opbevaringsforhold
6.4 Special precautions for storage
HDPE- beholder (high density polyethylen) med børnesikret polypropylenlåg.
High density polyethylene (HDPE) bottles closed with a child-resistant polypropylene closure.
Hver beholder indeholder 180 g REYATAZ og er pakket i en æske med en måleske.
Each bottle contains 180 g of REYATAZ and is packaged in a carton with a measuring spoon.
104 BILAG II
101 ANNEX II
105 A.
102 A.
Bristol- Myers Squibb, Champ “ Lachaud ”, La Goualle, F- 19250 Meymac, Frankrig
Bristol-Myers Squibb, Champ “ Lachaud”, La Goualle, F-19250 Meymac, France
Bristol- Myers Squibb, Rue du Docteur Gilles, F- 28230 Epernon, Frankrig
Bristol-Myers Squibb, Rue du Docteur Gilles, F-28230 Epernon, France
Pharmacovigilance system Indehaveren af markedsføringstilladelsen skal sikre, at pharmacovigilancesystemet, som står beskrevet i version 3. 0 i Modul 1. 8. 1 i ansøgningen om markedsføringstilladelse, er på plads og fungerer før og efter produktet er markedsført.
Pharmacovigilance system The MAH must ensure that the system of pharmacovigilance, as described in version 3.0 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 er forpligtet til at udføre undersøgelser og yderligere pharmacovigilance- aktiviteter som beskrevet i Pharmacovigilanceplanen i overensstemmelse med version 1. 0 af Risk Management Planen (RMP), der er beskrevet i Modul 1. 8. 2 i ansøgningen om markedsføringstilladelse samt alle efterfølgende RMP- opdateringer, der er vedtaget af CHMP.
Risk Management plan The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in version 1.0 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.
106 BILAG III
103 ANNEX III
107 A.
104 A.
108 OPLYSNINGER, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE OG PÅ DEN INDRE EMBALLAGE
105 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
ANGIVELSE AF AKTIVT STOF/ AKTIVE STOFFER Hver kapsel indeholder 100 mg atazanavir (som sulfat).
Each capsule contains 100 mg of atazanavir (as sulphate).
Æske og etiket til beholderpakning (1 beholder): 60 hårde kapsler
60 hard capsules
Læs venligst indlægssedlen før anvendelse.
Read the package leaflet before use.
Blisterpakning:
106 Blister pack:
109 Opbevares i den orginale yderpakning.
Store in the original package
60hårde kapsler:
Bottle pack 60 hard capsules:
60 hårde kapsler:
60 hard capsules:
Ydre æske:
Outer carton:
110 MINDSTEKRAV TIL OPLYSNINGER PÅ BLISTERKORT ELLER BLISTERSTRIPS
107 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
111 OPLYSNINGER, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE OG PÅ DEN INDRE EMBALLAGE
108 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
ANGIVELSE AF AKTIVT STOF/ AKTIVE STOFFER Hver kapsel indeholder 150 mg atazanavir (som sulfat).
Each capsule contains 150 mg of atazanavir (as sulphate).
Blisterpakning:
109 Blister pack:
112 Opbevares i den orginale yderpakning.
Store in the original package
113 MINDSTEKRAV TIL OPLYSNINGER PÅ BLISTERKORT ELLER BLISTERSTRIPS
110 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
114 OPLYSNINGER, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE OG PÅ DEN INDRE EMBALLAGE
111 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
ANGIVELSE AF AKTIVT STOF/ AKTIVE STOFFER Hver kapsel indeholder 200 mg atazanavir (som sulfat).
Each capsule contains 200 mg of atazanavir (as sulphate).
Blisterpakning:
112 Blister pack:
115 Opbevares i den orginale yderpakning.
Store in the original package
116 MINDSTEKRAV TIL OPLYSNINGER PÅ BLISTERKORT ELLER BLISTERSTRIPS
113 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
117 OPLYSNINGER, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE OG PÅ DEN INDRE EMBALLAGE
114 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
ANGIVELSE AF AKTIVT STOF/ AKTIVE STOFFER Hver kapsel indeholder 300 mg atazanavir (som sulfat).
Each capsule contains 300 mg of atazanavir (as sulphate).
Æske og etiket til beholderpakning (1 beholder): 30 hårde kapsler Beholderpakning:
30 hard capsules Carton Bottle pack:
(3 beholdere):
(3 bottles):
3 x 30 hårde kapsler (3 beholdere med 30 hårde kapsler) Etiket til beholderpakning:
3 x 30 hard capsules (3 bottles of 30 hard capsules) Label Bottle pack:
30 hårde kapsler fra en multipakning med 3 beholdere
30 hard capsules from a multi-pack comprising 3 bottles
Må ikke opbevares over 25°C.
115 Do not store above 25°C.
118 Blisterpakning:
Blister pack:
Opbevares i den orginale yderpakning.
Store in the original package
30hårde kapsler:
Bottle pack 30 hard capsules:
EU/ 1/ 03/ 267/ 008 3 x 30 hårde kapsler:
EU/ 1/ 03/ 267/ 008 3 x 30 hard capsules:
30 hårde kapsler:
30 hard capsules:
119 MINDSTEKRAV TIL OPLYSNINGER PÅ BLISTERKORT ELLER BLISTERSTRIPS
116 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
120 OPLYSNINGER, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE OG PÅ DEN INDRE EMBALLAGE
117 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
ÆSKE OG ETIKET TIL FLASKE MED ORALT PULVER
CARTON AND LABEL FOR BOTTLE WITH ORAL POWDER
REYATAZ 50 mg/ 1, 5 g oralt pulver atazanavir
REYATAZ 50 mg/ 1.5 g oral powder atazanavir