qanastek/EMEA-V3 huggingface dataset:
Detailed information on this medicinal product is available on the website of the European Medicines Agency (EMEA) http: / /www. emea. europa. eu
63 Informazzjoni dettaljata dwar din il- mediċina tinsab fuq il- website ta ’ l- Aġenzija Ewropea dwar il - Mediċini (EMEA): http: // www. emea. europa. eu /
REYATAZ 300 mg hard capsules
REYATAZ 300 mg kapsuli iebsin.
Each capsule contains 300 mg of atazanavir (as sulphate)
Kull kapsula fiha 300 mg ta 'atazanavir (bħala sulfat)
164.36 mg of lactose per capsule.
164, 36 mg ta 'lactose kull kapsula.
Hard capsule Opaque red and blue capsule printed with white ink, with "BMS 300 mg" on one half and with "3622" on the other half.
Kapsula iebsa Kapsula opaka ħamra u blu stampata b’ inka bajda, b ’ "BMS 300 mg" fuq nofs u b ’ "3622" fuq in- nofs l - ieħor
62 Method of administration: for oral administration.
65 Kif jingħata: jittieħed mill- ħalq.
63 There have been reports of increased bleeding, including spontaneous skin haematomas and haemarthroses, in type A and B haemophiliac patients treated with protease inhibitors.
Hemm rapporti li pazjenti li jbatu minn emofilja tip A u B li ġew ikkurati b’ inibituri ta ’ proteasi kellhom iktar fsada, inkluż ematomi u emartrosi spontanja fil- ġilda.
64 Relevant examples are cytomegalovirus retinitis, generalised and/ or focal mycobacterial infections, and Pneumocystis carinii pneumonia.
67 mikobatteriċi ffukati, u Pneumocystis carinii pneumonia.
65 Other interactions Interactions between atazanavir/ ritonavir and protease inhibitors, antiretroviral agents other than protease inhibitors, and other non-antiretroviral medicinal products are listed in the tables below (increase is indicated as “↑”, decrease as “↓”, no change as “↔”, twice daily as “ BID” and once daily as “ QD”).
68 Interazzjonijiet oħra L- interazzjonijiet bejn atazanavir/ ritonavir u inibituri protease, aġenti antiretrovirali li mhumiex inibituri protease, u prodotti mediċinali oħra li mhumiex antiretrovirali huma elenkati fit- tabella ta 'hawn isfel (żieda hija indikata bħala “ ↑ ”, tnaqqis bħala “ ↓ ”, l- ebda bidla bħala “ ↔ ”, darbtejn kuljum bħala “ BID ” u darba kuljum bħala “ QD ”).
(0.08, 0.21) (0.06, 0.18) (0.10, 0.27) with ddI+d4T
69
67 Co-administered medicinal
Antifungali
Medicinal
70
68 Co-administered medicinal
Prodotti mediċinali mogħtija Prodott
Sildenafil
73
70 Co-administered medicinal
t dwar l- għoti fl- istess ħin
4.7 Effects on ability to drive and use machines
75 4. 7 Effetti fuq il- ħila biex issuq u tħaddem magni
Renal and urinary disorders:
76 addominali, stomatite aphthous, gass fl- istonku, ħalq xott
74 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).
B’ dożi għoljin li jwasslu għal riskju għoli għall- mediċina, ġiet innotata suffejra minħabba iperbilirubinemja indiretta (mhux konjugata) (mhux konnessa ma ’ tibdil fit- test tal- funzjoni tal- fwied) jew titwil ta ’ l- intervall PR (ara sezzjonijiet 4. 4. or 4. 8).
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.
78 Pazjenti li qatt qabel ma ħadu kura antiretroviraliF’ pazjenti li qatt qabel ma ħadu kura antiretrovirali, is- sostituzzjoni I50L, kultant flimkien ma ’ bidla fl- A71V, hija sostituzzjoni ta ’ reżistenza firmatarja għal atazanavir.
Table 2:
79 Tabella 2:
76 CD4 count
72 (n=225)
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.
80 ħadu REYATAZ + ritonavir u lopinavir + ritonavir arm kien rispettivament ta ’ 36% u 42%.
78 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.
Kif jitneħħa: wara doża waħda ta ’ 400 mg ta ’ 14C- atazanavir, 79% u 13% tat- total tar- radjuattività ġie rkuprat rispettivament fil- purgar u fl- urina.
Gelatine Red iron oxide Black iron oxide Yellow iron oxide Indigocarmin (E132) Titanium dioxide (E171)
Gelatin Ossidu tal- ħadid aħmar Ossidu tal- ħadid iswed Ossidu tal- ħadid isfar Indigocarmin (E132) Titanium dioxide (E171)
White ink containing:
83 Linka bajda fiha:
80 6.5 Nature and contents of container
6. 5 In- natura tal- kontenitur u ta ’ dak li hemm ġo fih
Each carton contains one high-density polyethylene (HDPE) bottle or three high-density polyethylene (HDPE) bottles closed with child-resistant polypropylene closure.
Kull kartuna fiha flixkun wieħed ta 'polyethylene ta' densità għolja (HDPE) jew tliet fliexken tal - polyethylene ta ’ densità għolja (HDPE) magħluq b' tapp tal- polypropylene li t- tfal isibu diffiċli biex jiftħu.
Each bottle contains 30 hard capsules.
Kull flixkun fih 30 kapsuli iebsin.
Each carton contains 30 x 1 capsules; 5 blister cards of 6 x 1 capsules each in Alu/ Alu perforated unit dose blisters.
Kull kartuna fiha 30 x 1 kapsula; 5 folji ta ’ 6 x 1 kapsula kull waħda f’ folji ta ’ Alu/ Alu ipperforat f’ doża ta ’ unità waħda.
REYATAZ 50 mg/ 1.5 g oral powder
REYATAZ 50 mg/ 1. 5 g trab orali
One measuring spoon of 1.5 g oral powder contains 50 mg atazanavir (as sulphate).
Mgħarfa waħda tad- doża ta ’ 1. 5 g trab orali jkun fiha 50 mg atazanavir (bħala sulphate).
150 mg of aspartame and 1,218.15 mg of sucrose per measuring spoon of 1.5 g oral powder
150 mg ta 'aspartame u 1, 218. 15 mg ta' sucrose għal kull mgħarfa tad- doża ta '1. 5 g trab orali
Oral powder.
Trab orali.
Off-white to pale yellow powder.
Trab offwajt għal safrani ċar.
Based on available virological and clinical data, no benefit is expected in patients with strains resistant to multiple protease inhibitors (≥ 4 PI mutations).
Minn tagħrif viroloġiku u kliniku, mhux mistenni ebda ġid lill- pazjenti f’ kondizzjoni fejn il- virus huwa reżistenti għall- inibituri tal - proteasi multipliċi (≥ 4 mutazzjonijet PI).
The recommended dose of oral powder is 300 mg (6 level measuring spoons) once daily taken with ritonavir 100 mg once daily and with food.
Adulti: id- doża rrikmandata ta ’ REYATAZ trab orali hija ta ’ 300 mg darba kuljum li tittieħed flimkien ma ’ ritonavir 100 mg darba kuljum u ma ’ l- ikel.
One measuring spoon of 1.5 g of oral powder contains 50 mg atazanavir.
Ritonavir jingħata biex isaħħaħ il- qawwa farmakokinetika ta ’ atazanavir (ara sezzjonijiet 4. 5 u 5. 1).
REYATAZ with ritonavir should be used with caution in patients with mild
REYATAZ ma ’ ritonavir għandu jintuża b’ attenzjoni f’ pazjenti b’ indeboliment epatiku ħafif.
REYATAZ should not be used in patients with moderate to severe hepatic impairment (see sections 4.3, 4.4 and 5.2).
REYATAZ m’ għandux jintuża f’ pazjenti b’ indeboliment epatiku minn moderat għal sever (ara sezzjonijiet 4. 3, 4. 4 u 5. 2).
The oral powder should be taken with food.
86 It- trab orali għandu jingħata ma ’ l- ikel.
The prescriber should advise the patient to scoop an overfilled spoon of loose powder from the bottle using the measuring spoon provided.
Min jordna l- mediċina għandu jirrikmanda lill- pazjent biex jimsaħ l- imgħarfa mfawwra bit- trab mill - flixkun permezz tal- mgħarfa tad- doża ipprovduta.
The patient should then gently level the powder in the spoon by scraping the extra powder back into the bottle using a flat edge of a knife or spatula.
Il- pazjent, bil- galbu, għandu jillivella t- trab fl - imgħarfa tad- doża billi jitfa ’ lura fil- flixkun it- trab żejjed billi juża spatula jew sikkina bit- tarf ċatt.
Patients should be advised not to pack the powder into the spoon or to attempt to level the powder by shaking or tapping the spoon.
Il - pazjent ma għandux jiġi rikmandat li jillivella t- trab billi jċaqlaq jew itaptap l- imgħarfa.
The oral powder may be mixed with water, milk, applesauce or yoghurt.
It- trab orali jista ’ jitħallat ma ’ l- ilma, jogurt, ħalib, zalza tat- tuffieħ.
Once the oral powder is mixed with these, it should be used within 6 hours.
Meta it- trab orali jitħallat ma 'dawn, irid jintuża fi żmien 6 sigħat.
Hypersensitivity to the active substance or to any of the excipients (see section 6.1).
Sensittività eċċessiva għas- sustanza attiva jew għal sustanzi mhux attivi (ara sezzjoni 6. 1).
Patients with chronic hepatitis B or C and treated with combination antiretroviral therapy are at an increased risk for severe and potentially fatal hepatic adverse reactions.
Pazjenti li jbatu minn epatite kronika B jew C u kkurati b’ taħlita ta ’ terapija antiretrovirali għandhom iktar riskju ta ’ reazzjonijiet avversivi, epatiċi li jkunu gravi u potenzjalment fatali.
In case of concomitant antiviral therapy for hepatitis B or C, please refer also to the relevant Summary of Product Characteristics for these medicinal products (see section 4.8).
F’ każ ta ’ taħlita ta ’ terapija antiretrovirali għall- epatite B jew Ċ, jekk jogħġbok irreferi wkoll għas- Sommarju tal- Karatteristiċi tal - Prodott għal dawn il- prodotti mediċinali (ara sezzjoni 4. 8).
In patients with pre-existing conduction problems (second degree or higher atrioventricular or complex
F’ pazjenti li diġà għandhom problemi fit- trasmissjoni (bundle- branch tat- tieni grad jew ogħla, atriju- ventrikulari jew kumpless), REYATAZ għandu jintuża b’ attenzjoni u biss jekk il- vantaġġi huma akbar mir- riskji (ara sezzjoni 5. 1).
Particular caution should be used when prescribing REYATAZ in association with medicinal products which have the potential to increase the QT interval and/ or in patients with pre-existing risk factors (bradycardia, long congenital QT, electrolyte imbalances (see sections 4.8 and 5.3).
87 prodotti mediċinali li jistgħu jżidu l- intervall QT u/ jew f' pazjenti li diġà għandhom fatturi ta 'riskju (bradikardja, QT konġenitali twila, żbilanċi ta' elettroliti (ara sezzjonijiet 4. 8 u 5. 3).
There have been reports of increased bleeding, including spontaneous skin haematomas and haemarthroses, in type A and B haemophiliac patients treated with protease inhibitors.
Hemm rapporti li pazjenti li jbatu minn emofilja tip A u B li ġew ikkurati b’ inibituri ta ’ proteasi kellhom iktar fsada, inkluż ematomi u emartrosi spontanja fil- gilda.
In some patients additional factor VIII was given.
Il- pazjenti ngħataw aktar Factor VIII.
In more than half of the reported cases, treatment with protease inhibitors was continued or reintroduced if treatment had been discontinued.
F’ iktar minn nofs il- każi rraportati, l- kura b’ inibituri ta ’ proteasi tkompliet jew reġgħet bdiet jekk kienet twaqqfet.
Diabetics REYATAZ oral powder contains 7.3 g sucrose per 300 mg daily dose.
Dijabete REYATAZ trab orali fih 7. 3 g ta ’ sucrose fid- doża ta ’ 300 mg li tingħata kuljum.
This should be taken into account in patients with diabetes mellitus.
Din għandha tittieħed f’ konsiderazzjoni f’ dawk il- pazjenti li għandhom id- dijabete.
Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.
Pazjenti bi problemi ereditarji rari ta ’ intolleranza għall- fructose, assorbiment ħażin ta 'glucose- galactose jew insuffiċenzja ta ’ sucrase- isomaltase m’ għandhomx jieħdu din il- mediċina.
Fat redistribution and metabolic disorders Combination antiretroviral therapy has been associated with the redistribution of body fat (lipodystrophy) in HIV patients.
Ri- distribuzzjoni ta ’ xaħam u disordnijiet metaboliċi Terapija kombinata antiretrovirali ġiet assoċjata ma ’ ri- distribuzzjoni ta ’ xaħam fil- ġisem (lipodistrofija) f’ pazjenti bl- HIV.
The long-term consequences of these reactions are currently unknown.
Il- konsegwenzi fit- tul ta ’ dawn ir- reazzjonijiet bħalissa għadhom mhux magħrufa.
A connection between visceral lipomatosis and protease inhibitors and lipoatrophy and nucleoside reverse transcriptase inhibitors has been hypothesised.
Ġie ipotezzat li hemm konnessjoni bejn il- lipomatosi vixxerali u l- inibituri proteasi u l- lipoatrofija u n- nukleosidiċi tat - transkriptasi riversibbli.
A higher risk of lipodystrophy has been associated with individual factors such as older age, and with drug related factors such as longer duration of antiretroviral treatment and associated metabolic disturbances.
Riskju akbar ta ’ lipodistrofija huwa assoċjat mal- preżenza ta ’ fatturi individwali, bħal età avanzata u fatturi marbuta ma ’ mediċini, bħal kura antiretrovali aktar fit- tul u disturbi assoċjati mal- metaboliżmu.
Clinical examination should include evaluation for physical signs of fat redistribution.
L- eżami kliniku għandu jinkludi valutazzjoni ta ’ sinjali fiżiċi ta ’ ri- distribuzzjoni tax- xaħam.
84 Indinavir is also associated with indirect (unconjugated) hyperbilirubinaemia due to inhibition of UGT.
Indinavir huwa wkoll assoċjat ma ’ iperbilirubinemja indiretta (mhux konjugata) minħabba l - inibizzjoni ta ’ UGT.
Nephrolithiasis Nephrolithiasis has been reported in patients receiving REYATAZ (see section 4.8).
88 Ġiet irrapportata nefrolitjasi f’ pazjenti li jirċievu REYATAZ (ara sezzjoni 4. 8).
Relevant examples are cytomegalovirus retinitis, generalised and/ or focal mycobacterial infections, and Pneumocystis carinii pneumonia.
Eżempji relevanti huma cytomegalovirus retinitis, infezzjonijiet ġeneralizzati u/ jew mikobatteriċi ffukati, u Pneumocystis carinii pneumonia.
85 REYATAZ oral powder contains aspartame as a sweetening agent.
Phenylketonuria REYATAZ trab orali fih aspartame bħala sweetener.
Aspartame provides a source of phenylalanine and, therefore, may not be suitable for persons with phenylketonuria.
Aspartame jipprovdi sors ta ’ phenylalanine u, għalhekk, mhux tajjeb għal nies li għandhom phenylketonuria.
4.5 Interaction with other medicinal products and other forms of interaction
89 4. 5 Prodotti mediċinali oħra li ma jaqblux ma ’ dan il- prodott u affarijiet oħra li jistgħu jibdlu l- effett farmaċewtiku tal- prodott
Other interactions Interactions between atazanavir/ ritonavir and protease inhibitors, antiretroviral agents other than protease inhibitors, and other non-antiretroviral medicinal products are listed in the tables below (increase is indicated as “↑”, decrease as “↓”, no change as “↔”, twice daily as “ BID” and once daily as “ QD”).
Interazzjonijiet oħra L- interazzjonijiet bejn atazanavir/ ritonavir u inibituri protease, aġenti antiretrovirali li mhumiex inibituri protease, u prodotti mediċinali oħra li mhumiex antiretrovirali huma elenkati fit- tabella ta 'hawn isfel (żieda hija indikata bħala “ ↑ ”, tnaqqis bħala “ ↓ ”, l- ebda bidla bħala “ ↔ ”, darbtejn kuljum bħala “ BID ” u darba kuljum bħala “ QD ”).
booster of atazanavir pharmacokinetics.
bħala tqawwija tal - farmakokinetiċi ta 'atazanavir.
No significant effect on lamivudine and zidovudine concentrations observed.
lamivudine u zidovudine.
The co-administration of REYATAZ/ ritonavir with abacavir is not expected to significantly alter the exposure of abacavir.
L- għoti fl- istess ħin ta 'REYATAZ/ ritonavir ma' abacavir mhux
products (dose in mg)
Prodotti mediċinali mogħtija fl- istess ħin (doża f’ mg)
product assessed
Prodott AUC Cmax Cmin mediċinali (90% CI) (90% CI) (90% CI) evalwat
co-administration
Rakkomandazzjonijie t dwar l- għoti fl- istess ħin
Didanosine should be taken at the fasted state 2 hours after
Didanosine għandu jittieħed fuq stonku vojt sagħtejn wara t - teħid ta 'REYATAZ/ ritonavir
single dose)
fl- istess ħin ma '
atazanavir,
↓0. 13
REYATAZ/ ritonavir
↓0. 11
simultaneous
↓0. 16
taken with food.
ma 'l- ikel.
The
L- għoti fl -
↓ 0.13
ddI+d4T (fuq stonku vojt)
↓ 0.11
(0. 08, 0. 21)
↓ 0.16
(0. 06, 0. 18)
administration
(0. 10, 0. 27)
with ddI+d4T
istess ħin ta 'REYATAZ/ ritonavir ma' stavudine
(0.08, 0.21)
atazanavir, mogħti mhuwiex mistenni li
(0.06, 0.18)
siegħa wara
(fasted)
↑1. 12
atazanavir, dosed
↔1. 03
significantly alter the
jibdel b' mod sinifikanti
1 hr after ddI+d4T
ddI+d4T (fuq stonku vojt)
(fasted)
(0. 64, 1. 67)
(0.64, 1.67)
(0. 67, 1. 18)
(0.67, 1.18)
(0. 61, 1. 73)
(0.61, 1.73)
l- esponiment ta 'stavudine.
Atazanavir concentrations were greatly decreased when co-administered with didanosine (buffered tablets) and stavudine.
Il- konċentrazzjonijiet ta 'atazanavir naqsu ħafna meta ngħata fl- istess ħin ma' didanosine (pilloli bafferjati) u stavudine.
The mechanism of interaction is a reduced solubility of atazanavir with increasing pH related to the presence of anti-acid agent in didanosine buffered tablets.
Il- mekkaniżmu ta 'interazzjoni huwa solubilità mnaqqsa b' żieda fil- pH relatata mal- preżenza ta' sustanza kontra l- aċidi fil- pilloli bafferjati ta 'didanosine.
No significant effect on didanosine and stavudine concentrations was observed.
Ma ġie osservat l- ebda effett sinifikanti fuq il- konċentrazzjonijiet ta 'didanosine u stavudine.
Didanosine (enteric coated
Didanosine (kapsuli enteriċi
Didanosine (with
Didanosine (ma 'l -
capsules) 400 mg single dose (atazanavir 300 mg QD with
miksija) 400 mg doża waħda (atazanavir 300 mg QD ma ’
food)
ikel)
section 4.4)
Cmax
87
Cmin
Recommendations concerning co-administration
t dwar l- għoti fl- istess ħin
clarithromycin
clarithromycin
↓ 0.30
(2. 35, 2. 88)
↓ 0.28
rakkomandazzjoni dwar tnaqqis fid- doża;
↓ 0.38
↓0. 30
clarithromycin
↓0. 28
(0.34, 0.42)
↓0. 38
should be exercised if
għalhekk, għandha
atazanavir
clarithromycin
↑ 1.28
(0. 26, 0. 34)
↔ 1.06
(0. 24, 0. 33)
↑ 1.91
(0. 34, 0. 42)
(1.66, 2.21)
atazanavir
Antifungals
(1. 66, 2. 21)
Ketoconazole 200 mg QD (atazanavir 400 mg QD)
Antifungali Ketoconazole 200 mg QD (atazanavir 400 mg QD)
No significant effect on atazanavir concentrations was observed.
Ma ġie osservat l- ebda effett sinifikanti fuq il- konċentrazzjonijiet ta 'atazanavir.
Ketoconazole and itraconazole should be used cautiously with
Mhumiex
Itraconazole, like ketoconazole, is a potent inhibitor as well as a substrate of CYP3A4.
Bħal ketoconazole, itraconazole huwa inibitur b' saħħtu kif ukoll substrat ta 'CYP3A4.
co-administration
SUSTANZI LI JNAQQSU L- AĊIDU Antagonisti tar- Riċettur H2 Famotidine 40 mg BID
(atazanavir 300 mg QD with
atazanavir
(0.75, 0.89)
↓ 0. 82
(0.79, 0.94)
↓0. 86
(0.64, 0.81)
↓0. 72
of REYATAZ/
M' hemmx bżonn ta '
ritonavir 100 mg QD) Proton pump inhibitors
(atazanavir 300 mg QD ma ’ ritonavir 100 mg QD)
Although not studied, similar results are expected with other H2-receptor antagonists.
Għalkemm mhux studjat, huma mistennija riżultati simili b' antagonisti REYATAZ/ ritonavir oħra tar- riċettur H2.
The relevance of these data for HIV infected patients is unknown since the intragastric pH may be higher in this population.
Mhix magħrufa r- rilevanza ta 'din l- informazzjoni meta jingħata ma' għal pazjenti infettati bl- HIV billi l- pH intragastriku jista 'jkun ogħla antagonist tar- riċettur f' din il- popolazzjoni.
Therefore, the magnitude of this effect may be more pronounced.
Għaldaqstant, il- kobor ta 'dan l- effett jista' jkun H2 antagonist, kollha aktar evidenti.
The mechanism of interaction is decreased solubility of atazanavir as intra- gastric pH increases with H2 blockers.
Il- mekkaniżmu ta 'interazzjoni huwa solubilità mnaqqsa bħala doża waħda ta' ta 'atazanavir billi l- pH intra- gastriku jiżdied bis- sustanzi li jimblukkaw kuljum ma' l- ikel.
Reductions in atazanavir concentrations may be avoided by temporal separation of REYATAZ and an H2-receptor antagonist as follows:
Jista 'l- H2. jiġi evitat tnaqqis fil - konċentrazzjonijiet ta' atazanavir permezz ta 'separazzjoni temporali ta' REYATAZ u antagonist tar- riċettur H2 kif ġej:
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.
REYATAZ 300 mg ma ’ ritonavir 100 mg darba kuljum ma 'l- ikel, sagħtejn qabel u mill- anqas 10 sigħat wara l- għoti ta' antagonist tar- riċettur H2.
Omeprazole 40 mg QD
Inibituri tal- proton pump Omeprazole 40 mg QD
0.39 0.44 0.35 hr after
0. 39
ritonavir 100 mg QD)
0. 44
(0.35, 0.45) (0.38, 0.51) (0.29, 0.41) omeprazole
0. 35
with proton pump inhibitors is not recommended.
ma 'inibituri tal- proton pump mhuwiex rakkomandat.
If the
Jekk il - kombinazzjoni ta '
Omeprazole 20 mg QD (atazanavir 400 mg QD with ritonavir 100 mg QD)
REYATAZ/ ritonavir
atazanavir (am):
(atazanavir 400 mg QD ma ’
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
↓0. 70 *
combination of REYATAZ/ ritonavir with a proton pump inhibitor is judged unavoidable, close clinical monitoring is
↓0. 69 *
Antacids
↓0. 69 *
The decrease in AUC, Cmax, and Cmin was not mitigated when an increased dose of REYATAZ/ ritonavir (400/ 100 mg once daily) was temporally separated from omeprazole by 12 hours.
ritonavir 100 mg QD)
Although not studied, similar results are expected with other proton pump inhibitors.
Għalkemm mhux studjat, huma doża ta 'REYATAŻ mistennija riżultati simili b’ inibituri oħra tal- proton pump.
This decrease in atazanavir exposure might negatively impact the efficacy of atazanavir.
Dan it - għal 400 mg ma 'tnaqqis fl- esponiment ta' atazanavir jista 'jaffettwa b' mod negattiv l - 100 mg ta' ritonavir; effikaċja ta 'atazanavir.
The mechanism of interaction is decreased solubility of atazanavir as intra-gastric pH increases with proton pump inhibitors.
Il- mekkaniżmu ta 'interazzjoni huwa solubilità m' għandhomx jinqabżu mnaqqsa billi l- pH intra- gastriku jiżdied b’ inibituri tal- proton pump. dożi ta' inibituri tal - proton pump komparabbli għal omeprazole 20 mg (ara sezzjoni 4. 4).
Antacids and medicinal products containing buffers ANTICOAGULANTS
Antaċidi Antaċidi u prodotti mediċinali li fihom baffers ANTIKOAGULANTI
ANTINEOPLASTICS AND IMMUNOSUPRESSANTS Antineoplastics Irinotecan
ANTINEOPLASTIĊI U IMMUNOSUPPRESSANTI
Atazanavir inhibits UGT and may interfere with the metabolism of irinotecan, resulting in increased irinotecan toxicities.
93
89 Co-administered medicinal
Prodotti mediċinali mogħtija Prodott
co-administration
Antineoplastiċi Irinotecan Immunosuppressanti
monitored for adverse events related to irinotecan.
Jekk REYATAZ/ ritonavir jingħata fl- istess ħin ma 'irinotecan, il- pazjenti għandhom jiġu mmonitorjati mill- qrib għal episodji avversi relatati ma' irinotecan.
Immunosuppressants Cyclosporin Tacrolimus Sirolimus CARDIOVASCULAR AGENTS Antiarrhythmics
Cyclosporin Tacrolimus Sirolimus SUSTANZI KARDJOVASKULARI Antiarritmiċi
Concentrations of these immunosuppressants may be increased when co-administered with REYATAZ/ ritonavir due to CYP3A4 inhibition.
Il- konċentrazzjonijiet ta 'dawn l- immunosuppressanti jistgħu jiżdiedu meta jingħataw fl- istess ħin ma' REYATAZ/ ritonavir minħabba l - inibizzjoni ta 'CYP3A4.
More frequent therapeutic concentration monitoring of these medicinal products is recommended until plasma levels have been stabilised.
Huwa rakkomandat monitoraġġ aktar frekwenti tal - konċentrazzjoni terapewtika ta 'dawn il - prodotti mediċinali sakemm il- livelli fil - plasma jistabbilizzaw ruħhom.
Amiodarone, Systemic lidocaine, Quinidine
Amiodarone, Systemic lidocaine, Quinidine
Concentrations of these antiarrhythmics may be increased when co-administered with REYATAZ/ ritonavir.
Il- konċentrazzjonijiet ta 'dawn is- sustanzi antiarritmiċi jistgħu jiżdiedu meta jingħataw fl- istess ħin ma' REYATAZ/ ritonavir.
The mechanism of amiodarone or systemic lidocaine/ atazanavir interaction is CYP3A inhibition.
Il- mekkaniżmu ta ’ amiodarone jew l- interazzjoni sistemika ta ’ lidocaine/ atazanavir hija l- inibizzjoni ta 'CYP3A.
Quinidine has a narrow therapeutic window and is contraindicated due to potential inhibition of CYP3A by REYATAZ/ ritonavir.
Quinidine għandu perjodu terapewtiku limitat u huwa kontra- indikat minħabba l- inibizzjoni potenzjali ta 'CYP3A minn REYATAZ/ ritonavir.
Caution is warranted and therapeutic concentration monitoring is recommended when available.
Hija mitluba kawtela u huwa rakkomandat monitoraġġ tal - konċentrazzjoni terapewtika jekk ikun disponibbli.
Calcium channel blockers Bepridil
Sustanzi li jimblukkaw il - kanali tal- kalċju Bepridil
Serum concentrations of verapamil may be increased by REYATAZ/ ritonavir due to CYP3A4 inhibition.
Il- konċentrazzjonijiet ta 'verapamil fis- serum jistgħu jiżdiedu b' REYATAZ/ ritonavir minħabba l- inibizzjoni ta' CYP3A4.
Caution should be exercised when verapamil is co-administered with REYATAZ/ ritonavir.
Għandha tintuża kawtela meta verapamil jingħata fl - istess ħin ma 'REYATAZ/ ritonavir
Fluticasone propionate intranasal 50 µg 4 times daily for 7 days (ritonavir 100 mg capsules BID)
Fluticasone propionate minn ġo l- imnieħer 50 µg 4 darbiet kuljum għal 7 ijiem (kapsuli ritonavir 100 mg BID)
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).
Għandu
Co-administered medicinal products (dose in mg)
Prodott AUC Cmax Cmin
Moreover, in case of withdrawal of glucocorticoids, progressive dose reduction may have to be performed over a longer period.
Barra minn hekk, f' każ ta 'rtirar tal - glukokortikojdi, jista ’ jkun hemm bżonn li jsir tnaqqis progressiv tad- doża fuq perjodu itwal.
ERECTILE DYSUNCTION PDE5 Inhibitors Sildenafil
DISFUNZJONI TA 'L- EREZZJONI Inibituri PDE5 Sildenafil
Sildenafil is metabolised by CYP3A4.
Sildenafil huwa metabolizzat minn CYP3A4.
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.
L- għoti fl- istess ħin ma ’ REYATAZ/ ritonavir jista 'jirriżulta f' konċentrazzjonijiet akbar ta' sildenafil u żieda fl- episodji avversi relatati ma 'sildenafil, fosthom pressjoni baxxa, bidliet viżwali, u prijapiżmu.
The mechanism of the sildenafil/ atazanavir interaction is CYP3A4 inhibition.
Il- mekkaniżmu ta 'l - interazzjoni ta' sildenafil/ atazanavir hija l- inibizzjoni ta 'CYP3A4.
Patients should be warned about these possible side effects.
Il- pazjenti għandhom jiġu mwissija dwar dawn l- effetti sekondarji li jista 'jkun hemm.
HERBAL PRODUCTS
PRODOTTI MILL - ĦXEJJEX
Concomitant use of St.
L- użu konkomitanti ta 'St.
John's wort with REYATAZ/ ritonavir may be expected to result in significant reduction in plasma levels of atazanavir.
John' s wort ma ’ REYATAZ/ ritonavir jista ’ jiġi mistenni li jirriżulta fi tnaqqis sinifikanti fil- livelli ta 'atazanavir fil - plasma.
This effect may be due to an induction of CYP3A4.
Dan l- effett jista ’ jkun minħabba induzzjoni ta ’ CYP3A4.
There is a risk of loss of therapeutic effect and development of resistance (see section 4.3).
Hemm riskju ta 'telf ta' l- effett terapewtiku u żvilupp ta 'reżistenza (ara sezzjoni 4. 3).
Co-administration of REYATAZ/ ritonavir with products containing St.
L- għoti fl- istess ħin ta 'REYATAZ/ ritonavir ma' prodotti li fihom St.
John's wort is contraindicated.
John' s wort huwa kontra- indikat.
HORMONAL CONTRACEPTIVES Ethinyloestradiol 35 μ g + norethindrone (atazanavir 400
Ethinyloestradiol 35 μg + norethindrone (atazanavir 400 mg QD)
Buprenorphine, QD, stable maintenance dose,
Buprenorphine, QD, doża ta 'manteniment stabbli,
buprenorphine ↑ 1.67 ↑ 1.37 ↑ 1.69
buprenorphine ↑1. 67 ↑1. 37
Co-administration warrants
L- għoti fl- istess ħin jitlob monitoraġġ
(atazanavir 300 mg QD with ritonavir 100 mg QD)
Prodotti mediċinali mogħtija Prodott
norbuprenorphine ↑ 2.05 ↑ 1.61 ↑ 2.01 The mechanism of interaction is CYP3A4 and UGT1A1 inhibition.
Cmin
A dose reduction of buprenorphine may be considered
Rakkomandazzjonijie
Methadone, stable maintenance dose (atazanavir 400 mg QD)
fl- istess ħin (doża f’ mg)
No significant effect on methadone concentrations was observed.
mediċinali evalwat
No dosage adjustment is necessary if methadone is
(90% CI) (90% CI) (90% CI)
91
t dwar l- għoti fl- istess ħin
Co-administered medicinal
(atazanavir 300 mg QD ma 'ritonavir 100 mg QD)
Medicinal
norbuprenorphine
AUC
↑2. 05
Cmax
↑1. 61
Cmin
↑2. 01
Recommendations
Jista 'jiġi
products (dose in mg)
Il- mekkaniżmu ta 'interazzjoni huwa l- inibizzjoni ta' CYP3A4 u
product assessed
UGT1A1.
(90% CI) (90% CI) (90% CI)
kkunsidrat tnaqqis fid - doża ta ’ buprenorphine
co-administration
Methadone, doża ta 'manteniment stabbli (atazanavir 400 mg QD)
SEDATIVES Benzodiazepines
Ma ġie osservat ebda effett sinifikanti fuq il- konċentrazzjonijiet tal - methadone.
expected if methadone is co-administered with REYATAZ and ritonavir, based on these data.
M' hemmx bżonn ta 'aġġustament fid- doża jekk il- methadone jingħata fl- istess ħin ma' REYATAZ u ritonavir.
coadministered with REYATAZ and ritonavir.
SEDATTIVI Benzodiazepines
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.
REYATAZ/ ritonavir m' għandux jingħata fl - istess ħin ma 'triazolam jew midazolam mogħti mill- ħalq (ara sezzjoni 4. 3), filwaqt li għandha tintuża kawtela meta jingħataw fl- istess ħin REYATAZ/ ritonavir ma' midazolam parenterali.
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.
Jekk REYATAZ jingħata fl - istess ħin ma 'midazolam parenterali, dan għandu jsir f' taqsima tal- kura intensiva (ICU) jew ambjent simili li jiżgura monitoraġġ kliniku mill- viċin u ġestjoni medika xierqa f' każ ta' depressjoni respiratorja u/ jew sedazzjoni twila.
4.7 Effects on ability to drive and use machines
96 4. 7 Effetti fuq il- ħila biex issuq u tħaddem magni
92 4.8 Undesirable effects
4. 8 Effetti mhux mixtieqa
Among patients receiving REYATAZ 300 mg with ritonavir 100 mg, the frequency of jaundice was 17%.
Fost il- pazjenti li ħadu REYATAZ 300 mg ma ’ ritonavir 100 mg, il- frekwenza tas- suffejra kienet ta ’ 17%.
common: vomiting, diarrhoea, abdominal pain, nausea, dyspepsia; uncommon: pancreatitis, gastritis, abdominal distension, stomatitis aphthous, flatulence, dry mouth
komuni: rimettar, dijarea, uġigħ addominali, dardir, Disturbi gastro- intestinali: dispepsja;
uncommon: nephrolithiasis, hematuria, proteinuria, pollakiuria; rare: kidney pain
97 mhux komuni: pankreatite, gastrite, distensjoni addominali, stomatite aphthous, gass fl- istonku, ħalq xott
common: rash; uncommon: urticaria, alopecia, pruritus;
mhux komuni: nefrolitjasi, ħematurja, proteinurja, Disturbi fil- kliewi u fis- sistema pollakurja; urinarja: rari: uġigħ fil- kliewi
rare: vesiculobullous rash, eczema, vasodilatation
komuni: raxx; Disturbi fil- ġilda u fit- tessuti ta 'mhux komuni: urtikarja, alopeċja, ħakk; taħt il- ġilda: rari: raxx bl- infafet, ekżema, vażodilazzjoni
Co-infected
Pazjenti infettati flimkien bil- virus ta 'l- epatite B u/ jew ta' l- epatite Ċ Fost l- 1, 151 pazjent li ħadu atazanavir 400 mg darba kuljum, 177 pazjent kienu infettati wkoll b’ epatite kronika B jew Ċ, u fost 655 pazjent li ħadu atazanavir 300 mg darba kuljum ma ’ ritonavir 100 mg darba kuljum, 97 pazjent ġew infettati wkoll b’ epatite kronika B jew Ċ.
94 patients were more likely to have baseline hepatic transaminase elevations than those without chronic viral hepatitis.
Il- pazjenti nfettati biż - żewġ tipi ta ’ epatite flimkien għandhom aktar ċans li jkollhom livelli ta ’ linja bażi ta 'transaminasi epatika elevati minn dawk li ma kellhomx epatite kronika virali.
Single doses up to 1,200 mg have been taken by healthy volunteers without symptomatic untoward effects.
Voluntieri f’ saħħithom ħadu doża waħda sa 1, 200 mg mingħajr ma kellhom effetti sintomatiċi mhux mixtieqa.
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).
B’ dożi għoljin li jwasslu għal riskju għoli għall- mediċina, ġiet innotata suffejra minħabba iperbilirubinemja indiretta (mhux konjugata) (mhux konnessa ma ’ tibdil fit- test tal- funzjoni tal- fwied) jew titwil ta ’ l- intervall PR (ara sezzjonijiet 4. 4. or 4. 8).
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.
99 Pazjenti li qatt qabel ma ħadu kura antiretroviraliF’ pazjenti li qatt qabel ma ħadu kura antiretrovirali, is- sostituzzjoni I50L, kultant flimkien ma ’ bidla fl- A71V, hija sostituzzjoni ta ’ reżistenza firmatarja għal 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.
Pazjenti li kienu għaddew minn kura antiretrovirali F' pazjenti li kienu għaddew minn kura antiretrovirali, ġew stabbiliti 100 iżolati minn pazjenti nnominati bħala fallimenti viroloġiċi fuq kura li kienet tinkludi jew atazanavir, atazanavir + ritonavir, jew atazanavir + saquinavir li żviluppaw reżistenza għal atazanavir.
Atazanavir susceptibility was evaluated in 943 clinical isolates from patients without prior atazanavir exposure and exhibited a wide array of genotypic and phenotypic patterns.
Reżistenza inkroċjata in vitro f’ virusijiet reżistenti għal inibituri protease oħra Is- suxxettibbilità għal atazanavir ġiet evalwata f' 943 iżolat kliniku minn pazjenti li ma kellhomx esponiment preċedenti għal atazanavir u wrew firxa sħiħa ta ’ mudelli ġenotipiċi u fenotipiċi.
In vitro, there was a clear trend toward decreased susceptibility to atazanavir as isolates exhibited high resistance levels to multiple protease inhibitors.
In vitro, kien hemm tendenza ċara lejn suxxettibbilità mnaqqsa għal atazanavir hekk kif l- iżolati wrew reżistenza kbira għal ħafna inibituri protease.
Table 2:
100 Tabella 2:
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)
lopinavir/ ritonavirb (400 mg/ 100 mg darbtejn kuljum)
96 CD4 count
72 (n=225)
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.
101 ħadu REYATAZ + ritonavir u lopinavir + ritonavir arm kien rispettivament ta ’ 36% u 42%.
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.
L- għoti fl- istess ħin ta ’ doża waħda ta ’ 300 mg dose ta ’ REYATAZ u ta ’ doża ta ’ 100 - mg ta ’ ritonavir ma ’ ikla ħafifa rriżultat f’ żieda ta ’ 33% fl- AUC u f’ żieda ta ’ 40% kemm fis- Cmax kif ukoll fil- konċentrazzjoni ta ’ 24 siegħa ta ’ atazanavir fir- rigward ta ’ l- istat ta ’ sawm.
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.
Kif jitneħħa: wara doża waħda ta ’ 400 mg ta ’ 14C- atazanavir, 79% u 13% tat- total tar- radjuattività ġie rkuprat rispettivament fil- purgar u fl- urina.
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).
Il- konċentrazzjoni ta ’ atazanavir ma ’ jew mingħajr ritonavir mistennija tiżdied f’ pazjenti li jbatu minn ħsara moderata jew qawwija fil- funzjoni epatika (ara sezzjonijiet 4. 2, 4. 3 and 4. 4).
The potential for PR prolongation should be considered in cases of overdose (see section 4.9).
F’ każi ta ’ doża eċċessiva, it- titwil ta ’ l- intervall PR għandu jiġi ikkonsidrat (ara sezzjoni 4. 9).
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
Fil- fniek tqal ġew osservati leżjonijiet imdaqqsin fl- istonku u fl- intestini tal- fenka mejta jew moribonda b’ dożi materni darbtejn u 4 darbiet l- ogħla doża amministrata waqt l- istudju dwar l- iżvilupp definittiv ta ’ l- embriju.
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.
Fil- valutazzjoni ta ’ l- iżvilupp, qabel u wara t- twelid, fil- firien, atazanavir ġab tnaqqis temporanju fil - piż korporali tal- frieħ, b’ doża tossika materna.
Aspartame (E951) Sucrose Orange-vanilla flavour including:
Aspartame (E951) Sucrose Togħma larinġ- vanilla inkluż:
Modified food starch Dextrose Butylhydroxytoluene (E321)
Starch modifikat Dextrose Butylhydroxytoluene (E321)
6.3 Shelf life
104 6. 3 Żmien kemm idum tajjeb il- prodott mediċinali
2 months.
sentejn Wara l- ftuħ: xahrejn
High density polyethylene (HDPE) bottles closed with a child-resistant polypropylene closure.
Flixkun ta 'polyethylene ta' densità għolja (HDPE) magħluq b' tapp tal- polypropylene li t- tfal isibu diffiċli biex jiftħu.
Each bottle contains 180 g of REYATAZ and is packaged in a carton with a measuring spoon.
Kull flixkun fih 180 g ta ’ REYATAZ u huwa ippakkjat f’ pakket tal- kartun b’ mgħarfa tad- doża.
101 ANNEX II
105 ANNESS II
MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE
DETENTUR( I) TA 'L- AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI GĦALL- ĦRUĠ TAL- LOTT
Bristol-Myers Squibb, Champ “ Lachaud”, La Goualle, F-19250 Meymac, France
Bristol- Myers Squibb, Champ “ Lachaud ”, La Goualle, F- 19250 Meymac, Franza
Bristol-Myers Squibb, Rue du Docteur Gilles, F-28230 Epernon, France
Bristol- Myers Squibb, Rue du Docteur Gilles, F- 28230 Epernon, Franza
Bristol-Myers Squibb S. r. l., Contrada Fontana del Ceraso, 03012 Anagni (FR), Italy
Bristol- Myers Squibb S. r. l., Contrada Fontana del Ceraso, 03012 Anagni (FR), L- Italja
CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
• KONDIZZJONIJIET JEW RESTRIZZJONIJIET FIR- RIGWARD TA ’ L- UŻU MINGĦAJR PERIKLU U EFFETTIV TAL- PRODOTT MEDIĊINALI
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.
Sistema ta ’ farmakoviġilanza Id- detentur ta ’ l- awtorizzazzjoni għat- tqegħid fis- suq għandu jiżgura li s- sistema ta ’ farmakoviġilanza, kif deskritta fil- verżjoni 3. 0 ippreżentata fil- Modulu 1. 8. 1. ta ’ l- Applikazzjoni ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- Suq, tkun fis- seħħ u li din tkun qed taħdem tajjeb qabel u waqt li l- prodott ikun fis - suq.
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.
Pjan ta ’ Ġestjoni tar- Riskji Id- detentur ta ’ l- awtorizzazzjoni għat- tqegħid fis- suq jimpenja ruħu li jwettaq l- istudji u l- attivitajiet ta ’ farmakoviġilanza addizzjonali mogħtija fid- dettall fil- Pjan ta ’ Farmakoviġilanza, kif miftiehem fil - verżjoni 1. 0 tal- Pjan ta ’ Ġestjoni tar- Riskji (RMP) ppreżentat fil- Modulu 1. 8. 2. ta ’ l- Applikazzjoni ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- Suq u kwalunkwe aġġornament sussegwenti ieħor tal- RMP miftiehem mill- CHMP.
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
Barra minn hekk, għandu jiġi ppreżentat RMP aġġornat Meta tiġi rċevuta informazzjoni ġdida li jista ’ jkollha impatt fuq l- Ispeċifikazzjoni tas- Sigurtà, il- Pjan ta ’ Farmakoviġilanza jew l- attivitajiet ta ’ minimizzazzjoni tar- riskji Fi żmien 60 jum minn meta tkun intlaħqet mira importanti (farmakoviġilanza jew minimizzazzjoni tar- riskji) Fuq talba ta ’ l- EMEA
103 ANNEX III
107 ANNESS III
105 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
109 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA U L- PAKKETT LI JMISS MAL- PRODOTT
OUTER CARTON TEXT (BOTTLE AND BLISTER PRESENTATIONS) AND BOTTLE LABEL TEXT
TEST FUQ IL- KARTUNA TA ’ BARRA (PREŻENTAZZJONI FIL- FLIEXKEN U FIL- FOLJI) U TEST FUQ IT- TIKKETTA TAL- FLIEXKEN
REYATAZ 100 mg hard capsules atazanavir
REYATAZ 100 mg kapsuli iebsin. atazanavir
Each capsule contains 100 mg of atazanavir (as sulphate).
Kull kapsula għandha 100 mg atazanavir (bħala sulphate).
Excipients: contains lactose (see leaflet for further information).
Sustanzi mhux attivi: fih lactose (ara l- fuljett għal aktar informazzjoni).
Carton and label bottle pack (1 bottle):
Carton and label bottle pack (1 bottle):
60 hard capsules
60 hard capsules
60 hard capsules
60 kapsuli iebsin
Capsules should be swallowed whole.
Il- kapsuli iebsin għandhom jinbelgħu sħaħ.
Read the package leaflet before use.
Arqa l- fuljett ta 'tagħrif qabel l- użu.
Bottle pack:
Pakkett tal- flixkun:
106 Blister pack:
110 Pakkett tal- folji:
Bottle pack 60 hard capsules:
Pakkett tal- flixkun 60 kapsuli iebsin:
Blister pack:
Pakkett tal- folji:
60 hard capsules:
60 kapsuli iebsin:
INSTRUCTIONS ON USE
STRUZZJONI DWAR L- UŻU
107 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
111 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ L- ISTRIXXI JEW FUQ IL- FOLJI
108 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
112 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA U L- PAKKETT LI JMISS MAL- PRODOTT
REYATAZ 150 mg hard capsules atazanavir
REYATAZ 150 mg kapsuli iebsin. atazanavir
Each capsule contains 150 mg of atazanavir (as sulphate).
Kull kapsula għandha 150 mg atazanavir (bħala sulphate).
109 Blister pack:
113 Pakkett tal- folji:
110 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
114 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ L- ISTRIXXI JEW FUQ IL- FOLJI
111 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
115 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA U L- PAKKETT LI JMISS MAL- PRODOTT
REYATAZ 200 mg hard capsules atazanavir
REYATAZ 200 mg kapsuli iebsin. atazanavir
Each capsule contains 200 mg of atazanavir (as sulphate).
Kull kapsula għandha 200 mg atazanavir (bħala sulphate).
112 Blister pack:
116 Pakkett tal- folji:
113 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
117 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ L- ISTRIXXI JEW FUQ IL- FOLJI
114 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
118 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA U L- PAKKETT LI JMISS MAL- PRODOTT
REYATAZ 300 mg hard capsules atazanavir
REYATAZ 300 mg kapsuli iebsin. atazanavir
Each capsule contains 300 mg of atazanavir (as sulphate).
Kull kapsula għandha 300 mg atazanavir (bħala sulphate).
30 hard capsules Carton Bottle pack:
30 hard capsules Pakkett tal- Kartun għall- fliexken:
(3 bottles):
(3 fliexken):
3 x 30 hard capsules (3 bottles of 30 hard capsules) Label Bottle pack:
3 x 30 kapsula iebsa (3 fliexken ta ’ 30 kapsula iebsa) Tikketta tal- pakkett tal- Fliexken:
30 hard capsules from a multi-pack comprising 3 bottles
30 kapsula iebsa minn pakkett multiplu magħmul minn 3 fliexken
30 hard capsules
30 kapsuli iebsin
Bottle pack:
119 Pakkett tal- flixkun:
115 Do not store above 25°C.
Taħżinx f’ temperatura ’ il fuq minn 25°C.
Bottle pack 30 hard capsules:
Pakkett tal- flixkun 30 kapsuli iebsin:
EU/ 1/ 03/ 267/ 008 3 x 30 hard capsules:
EU/ 1/ 03/ 267/ 008 3 x 30 kapsuli iebsin:
30 hard capsules:
30 kapsuli iebsin:
116 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
120 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ L- ISTRIXXI JEW FUQ IL- FOLJI
117 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
121 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA U IL- PAKKETT LI JMISS MAL- PRODOTT
CARTON AND LABEL FOR BOTTLE WITH ORAL POWDER
KARTUNA U TIKKETTA GĦAL FLIXKUN BI TRAB ORALI
REYATAZ 50 mg/ 1.5 g oral powder atazanavir
REYATAZ 50 mg/ 1. 5 g trab orali atazanavir
STATEMENT OF ACTIVE SUBSTANCE(S)
DIKJARAZZJONI TA ’ SUSTANZA( I) ATTIVA
One measuring spoon of 1.5 g oral powder contains 50 mg of atazanavir (as sulphate).
Kull mgħarfa tad- doża fiha 1. 5 g ta ’ trab orali li fih 50 mg ta ’ atazanavir (bħala sulphate).
Also contains aspartame (E951) and sucrose (see leaflet for further information).
Fih ukoll aspartame (E951) u sucrose (ara l- fuljett għal aktar informazzjoni).
180 g oral powder
180 g trab orali
Read the package leaflet before use.
Arqa l- fuljett ta 'tagħrif qabel tuża.
Uxbridge Business Park Sanderson Road Uxbridge UB8 1DH
BRISTOL- MYERS SQUIBB PHARMA EEIG Uxbridge Business Park Sanderson Road Uxbridge UB8 1DH Renju Unit
120 PACKAGE LEAFLET:
124 FULJETT TA 'TAGĦRIF:
Read all of this leaflet carefully before you start taking this medicine.
Aqra dan il- fuljett kollu qabel tibda tieħu l- mediċina Żomm dan il- fuljett.
What REYATAZ is and what it is used for 2.
X' inhu REYATAZ u għalxiex jintuża 2.
Before you take REYATAZ 3.
Qabel ma tieħu REYATAZ 3.
How to take REYATAZ 4.
Kif għandek tieħu REYATAZ 4.
How to store REYATAZ 6.
Kif taħżen REYATAZ 6.
WHAT REYATAZ IS AND WHAT IT IS USED FOR
X' INHU REYATAZ U GĦALXIEX JINTUŻA
REYATAZ is an antiviral (or antiretroviral) medicine.
REYATAZ huwa mediċina antivirali (jew antiretrovirali).
It is one of a group called protease inhibitors.
Huwa wieħed mill- grupp magħruf bħala inibituri tal- proteasi.
These medicines control Human Immunodeficiency Virus (HIV) infection by stopping a protein that the HIV needs for its multiplication.
Dawn il- mediċini jikkontrollaw l- infezzjoni tal- Human Immunodeficiency Virus (HIV) billi jwaqqfu proteina li l- HIV għandu bżonn biex ikun jista 'jimmultiplika.
They work by reducing the amount of HIV in your body and this in turn, strengthens your immune system.
Huma jaħdmu billi jnaqqsu l- ammont ta 'HIV f' ġismek u dan, min- naħa tiegħu jsaħħaħ is- sistema ta' immunità.
In this way REYATAZ reduces the risk of developing illnesses linked to HIV infection.
B’ hekk REYATAZ inaqqas ir- riskju li tiżviluppa mard assoċjat ma ’ l- infezzjoni ta ’ l- HIV.
Your doctor has prescribed REYATAZ for you because you are infected by the HIV that causes Acquired Immunodeficiency Syndrome (AIDS).
It- tabib tiegħek kitiblek ir- riċetta għal REYATAZ għax int infettat bl- HIV li jikkawża Acquired Immunodeficiency Syndrome (AIDS).
It is normally used in combination with other anti- HIV medicines.
Normalment jintuża flimkien ma 'mediċini oħra li jaħdmu kontra l- HIV.
Your doctor will discuss with you which combination of these medicines with REYATAZ is best for you.
It- tabib jiddiskuti miegħek x’ mediċini flimkien ma ’ REYATAZ huma l- aħjar għalik.
REYATAZ is not a cure for HIV infection.
REYATAZ mhux fejqan għall- infezzjoni b’ HIV.
You may continue to develop infections or other illnesses linked to HIV infection.
Jista ’ jibqa ’ jkollok infezzjonijiet u mard ieħor li għandhom x’ jaqsmu ma ’ l- HIV.
Treatment with REYATAZ does not reduce the risk of passing HIV to others through sexual contact or blood contamination.
Il- kura b ’ REYATAZ ma tnaqqasx ir- riskju li tgħaddi l- HIV lil ħaddieħor permezz ta ’ kuntatt sesswali jew bi tniġġis bid- demm.
You must continue to take appropriate precautions to avoid giving the virus to others.
Għandek tibqa ’ tieħu l - prekawzjonijiet kollha meħtieġa biex tevita li tgħaddi l- virus lil ħaddieħor.
2 BEFORE YOU TAKE REYATAZ
2 QABEL MA TIEĦU REYATAZ
Do not take REYATAZ
Tiħux REYATAZ
if you are allergic (hypersensitive) to atazanavir or any of the other ingredients of REYATAZ if you have moderate to severe liver problems.
jekk inti allerġiku (tbati minn sensittività eċċessiva) għal atazanavir jew sustanzi oħra ta ’ REYATAZ jekk għandek problemi tal- fwied moderati għal serji.