qanastek/EMEA-V3 huggingface dataset:
- -
- qoxra tal- kapsula: gelatine, titanium dioxide (E171) u indigo carmine (E132)
capsule shell: gelatine, titanium dioxide (E171) and indigo carmine (E132) printing ink: shellac, propylene glycol, potassium hydroxide and black iron oxide (E172).
- linka ta ’ l- istampar: shellac, propylene glycol, potassium hydroxide u black iron oxide
Revlimid 25 mg hard capsules: • The active substance is lenalidomide.
Revlimid 25 mg kapsuli iebsin: • Is- sustanza attiva hi lenalidomide.
Each capsule contains 25 mg of lenalidomide. • The other ingredients are:
Kull kapsula fiha 25 mg ta ’ lenalidomide. • Is- sustanzi l- oħra huma:
- -
- qoxra tal- kapsula: gelatine u titanium dioxide (E171)
capsule shell: gelatine and titanium dioxide (E171) printing ink: shellac, propylene glycol, potassium hydroxide and black iron oxide (E172).
- linka ta ’ l- istampar: shellac, propylene glycol, potassium hydroxide u black iron oxide
What Revlimid looks like and contents of the pack
95 Id- Dehra ta ’ Revlimid u l- kontenuti tal- pakkett
Revlimid 5 mg hard capsules are white, with “REV 5 mg” written on them.
Revlimid 5 mg kapsuli iebsin huma bojod, b ’ “ REV 5 mg ” miktuba fuqhom.
Revlimid 10 mg hard capsules are blue-green/pale yellow, with “REV 10 mg” written on them.
Revlimid 10 mg kapsuli iebsin huma blu- ħodor/ isfar ċar, b ’ “ REV 10 mg ” miktuba fuqhom.
Revlimid 15 mg hard capsules are pale blue/white, with “REV 15 mg” written on them.
Revlimid 15 mg kapsuli iebsin huma blu ċari/ bojod, b ’ “ REV 15 mg ” miktuba fuqhom.
Revlimid 25 mg hard capsules are white, with “REV 25 mg” written on them.
Revlimid 25 mg kapsuli iebsin huma bojod, b ’ “ REV 25 mg ” miktuba fuqhom.
The capsules are provided in packs.
Il- kapsuli huma pprovduti f’ pakketti.
Each pack contains three blisters, each with seven capsules.
Kull pakkett fih tliet folji, kull waħda b’ seba ’ kapsuli.
Marketing Authorisation Holder Celgene Europe Limited Riverside House Riverside Walk Windsor 87 Berkshire SL4 1NA United Kingdom
Id- detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- Suq Celgene Europe Limited Riverside House Riverside Walk Windsor Berkshire SL4 1NA Ir- Renju Unit
Manufacturer Penn Pharmaceutical Services Limited Tafarnaubach Industrial Estate Tredegar Gwent NP22 3AA United Kingdom
Manifattur Penn Pharmaceutical Services Limited Tafarnaubach Industrial Estate Tredegar Gwent NP22 3AA Ir- Renju Unit
For any information about this medicine, please contact the Marketing Authorisation Holder.
Għal kull tagħrif dwar dan il- prodott mediċinali, jekk jogħġbok ikkuntattja lid- detentur ta ’ l - awtorizzazzjoni għat- tqegħid fis- suq.
Detailed information on this medicine is available on the European Medicines Agency (EMEA) web site: http://www.emea.europa.eu/.
Informazzjoni dettaljata dwar din il- mediċina tinsab fuq il- website ta ’ l- Aġenzija Ewropeja dwar il- Mediċini (EMEA): http: // www. emea. europa. eu /.
It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the studies performed, to reach their recommendations on how to use the medicine.
Jispjega kif il- Kumitat għall- Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) ivvaluta l - istudji mwettqin, biex jissodisfa ir- rakkomandazzjonijiet tagħhom dwar kif tintuża l- mediċina.
What is Reyataz?
X’ inhu Reyataz?
Reyataz is a medicine that contains the active substance atazanavir.
Reyataz hu mediċina li fiha s- sustanza attiva atazanavir.
It is available as capsules (blue and white:
Jiġi bħala kapsuli (blù bl- abjad:
100 mg; light blue and blue:
100 mg;, ċelesti bil- blù:
150 mg; opaque blue:
150 mg; blù opak:
200 mg; red and blue:
200 mg; ħomor u blù:
300 mg) and as an oral powder (50 mg per 1.5 g measure).
300 mg) u bħala trab orali (50 mg kull unità tal- 1. 5g).
What is Reyataz used for?
Għal xiex jintuża Reyataz?
Reyataz is an antiviral medicine.
Reyataz hu mediċina antivirali.
It is used together with ritonavir (another antiviral medicine) and other antiviral medicines to treat adults infected with human immunodeficiency virus type 1 (HIV-1), a virus that causes acquired immune deficiency syndrome (AIDS).
Jintuża flimkien ma ’ ritonavir (mediċina antivirali oħra) u mediċini antivirali oħra fit- trattament ta ’ adulti infettati bil- vajrus tal- immunidefiċjenza umana tat- tip 1 (HIV- 1), virus li jikkawża l- vajrus tal- immunidefiċjenza umana (AIDS).
Doctors should prescribe Reyataz to patients who have received antiviral medicines for HIV infection before only once they have looked at these medicines and the likelihood that the virus will respond to Reyataz.
It- tobba għandhom jippreskrivu Reyataz lil pazjenti li jkunu diġà rċevew mediċini antivirali għall - infezzjoni tal- HIV ladarba jkunu raw dawn il- mediċini u xi tkun il- probabilità li l- vajrus jirrispondi għal Reyataz.
Based on the information available, the medicine is not expected to work in patients in whom many medicines in the same class as Reyataz (protease inhibitors) do not work or have stopped working.
Skont it- tagħrif disponibbli, il- mediċina mhix mistennija taħdem f’ pazjenti li fihom ma jkunux ħadmu jew ma jkunux baqgħu jaħdmu ħafna mediċini fl- istess klassi ta ’ Reyataz (inibitur tal - protiżi).
How is Reyataz used?
Kif jintuża Reyataz?
Treatment with Reyataz should be started by a doctor who has experience in the treatment of HIV infection.
It- trattament b’ Reyataz għandu jinbeda minn tabib li jkollu esperjenza fit- trattament tal- infezzjoni tal - HIV.
The recommended dose is 300 mg once a day.
Id- doża rakkomandata hi ta ’ 300 mg kuljum.
Each dose must be taken with 100 mg ritonavir and food.
Kull doża għandha tittieħed ma ’ 100 mg ritonavir u mal- ikel.
The oral powder can be used in patients who are unable to swallow capsules.
It- trab orali jista ’ jintuża f’ pazjenti li ma jkunux jistgħu jibilgħu kapsuli.
Reyataz should be used with caution in patients with mild liver problems, and should not be used in patients with moderate or severe liver problems.
Reyataz għandu jintuża b’ kawtela f’ pazjenti li jkollhom problemi żgħar fil- fwied, u m’ għandux jintuża f’ pazjenti bi problemi moderati jew severi fil- fwied.
How does Reyataz work?
Kif jaħdem Reyataz?
The active substance in Reyataz, atazanavir, is a protease inhibitor.
Is- sustanza attiva f’ Reyataz, atazanavir, hi inibitur tal- protiż.
It blocks an enzyme called protease, which is involved in the reproduction of HIV.
Din timblokka enzima imsejjħa protiż li għandu x’ jaqsam mar- riproduzzjoni tal- HIV.
When the enzyme is blocked, the virus does not reproduce normally, slowing down the spread of infection.
Meta din l- enzima tiġi imblukkata, il- vajrus ma jirriproduċix ruħu b’ mod normali, u dan inaqqas il- ħeffa li biha tixtered l- infezzjoni.
Ritonavir is another protease inhibitor that is used as a ‘ booster’.
Ritonavir hu inibitur tal- protiż ieħor li jintuża bħala ‘ booster ’.
It slows down the rate at which atazanavir is broken down, increasing the levels of atazanavir in the blood.
Dan inaqqas ir- rata ta ’ tkissir ta ’ atazanavir u b’ hekk jgħolli l- livell ta ’ atazanavir fid- demm.
This allows a lower dose of atazanavir to be used for the same antiviral effect.
Dan jippermetti li tintuża doża iżgħar ta ’ atazanavir għall - istess effett antivirali.
Reyataz, taken in combination with other antiviral medicines, reduces the amount of HIV in the blood and keeps it at a low level.
Reyataz, meħud flimkien ma ’ mediċini antivirali oħra, inaqqas l- ammont ta ’ HIV fid- demm u jżommu f’ livell baxx.
Reyataz does not cure HIV infection or AIDS, but it may
Reyataz ma jfejjaqx infezzjoni tal- HIV jew l- AIDS, iżda jista ’ jtawwal iż- żmien qabel ma tibda ssir ħsara lis- sistema immunitarja u qabel l- iżvilupp ta ’ infezzjonijiet u mardiet relatati mal- AIDS.
How has Reyataz been studied?
Kif ġie studjat Reyataz?
The effectiveness of Reyataz has been assessed in four main studies.
L- effikaċja ta ’ Reyataz ġiet valutata f’ erba ’ studji ewlenin.
One study involved 883 treatment-naïve patients (who had not taken treatment for HIV infection before), and the other three involved a total of 743 treatment-experienced patients (who had taken treatment for HIV infection before).
Studju minnhom involva 883 pazjent li kienu fuq it- trattament naïve (li qabel ma kienux ħadu trattament għall- infezzjoni tal- HIV) u fit- tlieta l- oħra ħadu sehem 743 pazjent li esperjenzaw it- trattament (li kienu diġà ħadu trattament għall- HIV).
In the study of treatment-naïve patients, the effectiveness of Reyataz was compared with that of lopinavir (another antiviral medicine), both taken with ritonavir.
Fl- istudju ta ’ pazjenti b’ trattament naïve l- effikaċja ta ’ Reyataz ġiet imqabbla ma ’ dik ta ’ lopinavir (mediċina antivirali oħra) meta t- tnejn li huma jiġu meħuda ma ’ ritonavir.
The third study compared the effectiveness of Reyataz plus either ritonavir or saquinavir with that of lopinavir plus ritonavir in 358 patients.
F’ pazjenti b’ trattament naïve l- ewwel żewġ studji qabblu l- effikaċja ta ’ Reyataz, meħud ma ’ saquinavir (mediċina antivirali oħra) iżda mingħajr ritonavir, mal- effikaċja tal- kombinazzjoni ta ’ ritonavir u saquinavir jew lopinavir.. It- tielet studju qabbel l- effikaċja ta ’ Reyataz flimkien ma ’ ritonavir jew saquinavir mal- effikaċja ta ’ lopinavir flimkien ma ’ ritonavir f’ 358 pazjent.
In all of the studies, the patients also took two nucleoside or nucleotide reverse transcriptase inhibitors (NRTIs, a type of antiviral medicine).
Fl- istudji kollha, il- pazjenti ħadu wkoll żewġ inibituri tan- nucleoside jew inibituri tan- nucleotide reverse transcriptors (NRTIs, tip ta ’ mediċina antivirali).
The main measure of effectiveness was the change in the levels of HIV in the patients’ blood (viral load).
Il- mezz ewlieni tal- kejl tal- effikaċja kien it - tibdil fil- livelli tal- HIV fid- demm tagħbija virali (viral load).
What benefit has Reyataz shown during the studies?
X’ inhuma l- benefiċċji ta ’ Reyataz li ntwerew f’ dawn l- istudji?
In treatment-naïve patients, Reyataz was as effective as lopinavir, when they were taken with ritonavir.
F’ pazjenti bi trattament naïve Reyataz kien effikaċi bħal lopinavir, meta ġew meħuda flimkien ma ’ ritonavir.
At the start of the study, the patients’ viral loads were around 88,100 copies/ ml, but after 48 weeks, 78% of the patients taking Reyataz (343 out of 440) had viral loads below 50 copies/ ml, compared with 76% of those taking lopinavir (338 out of 443).
Fil- bidu tal- istudju, it- tagħbijiet virali tal- pazjenti kienu madwar 88. 100 kopji/ ml, iżda wara 48 ġimgħa, 78% tal- pazjenti li jieħdu Reyataz (343 minn 440) kellhom tagħbijiet virali taħt il- 50 kopja/ ml, meta imqabbla mas- 76% ta ’ dawn li jieħdu lopinavir (338 minn 443).
In treatment-experienced patients, the results of the first study could not be interpreted, as a large number of patients left the study before its planned end.
F’ pazjenti li esperjenzaw it- trattament ir- riżultati tal- ewwel studju ta ’ Reyataz ma setgħux jiġu interpretati, għax numru kbir ta ’ pazjenti telqu mill- istudju qabel iż- żmien.
In the second study, the combination of lopinavir and ritonavir caused a greater reduction in viral load than Reyataz taken without ritonavir after 24 weeks.
Fit- tieni studju, il - kombinazzjoni ta ’ lopinavir ma ’ ritonavir naqqset it- tagħbija virali iktar milli naqqasha Reyataz meħud mingħajr ritonavir wara 24 ġimgħa.
In the third study, patients taking Reyataz or lopinavir, in combination with ritonavir, had similar falls in viral load after 24 and 48 weeks, having fallen by around 99% after 48 weeks.
Fit- tielet studju, il- pazjenti li kienu qed jieħdu Reyataz jew lopinavir, flimkien ma ’ ritonavir, kellhom tnaqqis simili fit- tagħbijiet virali wara 24 u 48 ġimgħa, bi tnaqqis ta ’ madwar 99% wara 48 ġimgħa.
This finding was maintained after 96 weeks.
Din is- sejba ġiet konfermata wara 96 ġimgħa.
What is the risk associated with Reyataz?
X’ inhu r- riskju assoċjat ma ’ Reyataz?
The most common side effects with Reyataz (seen in between 1 and 10 patients in 100) are headache, ocular icterus (yellowing of the eyes), vomiting, diarrhoea, abdominal (tummy) pain, nausea (feeling sick), dyspepsia (heartburn), rash, lipodystrophy syndrome (changes in the distribution of body fat), fatigue (tiredness) and jaundice (yellowing of the skin).
L- effetti sekondarji l- aktar komuni ta ’ Reyataz (li dehru f’ bejn pazjent wieħed u 10 pazjenti minn kull 100) huma uġiegħ ta ’ ras, sfura fl- abjad tal- għajnejn (icterus okulari), rimettar, dijareja, uġigħ addominali (fiż- żaqq), dardir (wieħed iħossu ma jiflaħx), dispepsja (ħruq fl- istonku), raxx, sindromu tal- lipodistrofija (tibdil fid- distribuzzjoni tax- xaħam tal- ġisem), dgħjufija u għeja u suffejra (sfurija tal- ġilda).
For the full list of all side effects reported with Reyataz, see the Package Leaflet.
Għal- lista sħiħa ta ’ effetti sekondarji rappurtati ma ’ Reyataz, ara l- Fuljett ta ’ Tagħrif.
Reyataz should not be used in people who may be hypersensitive (allergic) to atazanavir or any of the other ingredients, or who have moderate to severe problems with their liver.
Reyataz m’ għandux jintuża minn persuni li jistgħu jkunu allerġiċi għal atazanavir jew għal xi sustanza oħra tiegħu, jew li jkollhom problemi severi fil- fwied.
Reyataz must not be used in patients taking any of the following medicines: • rifampicin (used to treat tuberculosis); • St John’ s wort (a herbal preparation used to treat depression); • medicines that are broken down in the same way as Reyataz or ritonavir and are harmful at high levels in the blood.
Reyataz m’ għandux jintuża minn pazjenti li jkunu qed jieħdu xi mediċini minn dawn: • rifampicin (użat fit- trattament tat- tuberkulożi); • St John’ s wort (preparazzjoni tal- ħxejjex użata fit- trattament tad- dipressjoni); • mediċini li jitkissru bl- istess mod bħal Reyataz jew ritonavir u li jagħmlu l- ħsara meta jinstabu f’ livelli għolja fid- demm.
Caution is needed when Reyataz is taken at the same time as other medicines.
Meta Reyataz jittieħed ma ’ mediċini oħra, dan irid isir b’ kawtela.
See the Package Leaflet for full details.
Ara l- Fuljett ta ’ Tagħrif għad - dettalji kollha.
As with other anti-HIV medicines, patients taking Reyataz may also be at risk of osteonecrosis (death of bone tissue) or immune reactivation syndrome (symptoms of infection caused by the recovering immune system).
Bħal f’ mediċini oħra ta ’ kontra l- HIV, il- pazjenti li jkunu qed jieħdu Reyataz jistgħu jkunu wkoll f’ riskju ta ’ ostjonekrożi (mewt tat- tessut tal- għadam) jew tas- sindromu tar- riattivazzjoni immunoloġika (sintomi ta ’ infezzjoni kkawżata mis- sistema immunitarja li tkun qed tirkupra).
Patients who have problems with their liver may be at an elevated risk of liver damage when taking Reyataz.
Pazjenti li jkollhom problemi bil- fwied jisgħu jkunu f’ riskju ikbar ta ’ ħsara għall- fwied meta jieħdu Reyataz.
Why has Reyataz been approved?
Għaliex ġie approvat Reyataz?
The Committee for Medicinal Products for Human Use (CHMP) decided that Reyataz’ s benefits are greater than its risks for the treatment of HIV-1 infected adults in combination with other antiretroviral medicinal products.
Il- Kumitat għall- prodotti Mediċinali għal Użu mill- Bniedem (CHMP) iddeċieda li l- benefiċċji ta ’ Reyataz huma akbar mir- riskji tiegħu meta meħud flimkien ma ’ prodotti mediċinali antiretrovirali oħra, ta ’ adulti infettati bl- HIV- 1.
The Committee recommended that Reyataz be given marketing authorisation.
Il- Kumitat irrakomanda li Reyataz jingħata awtorizzazzjoni għat - tqegħid fis- suq.
Reyataz was originally authorised under ‘ Exceptional Circumstances’, because for scientific reasons it had not been possible to obtain complete information on the medicine.
Reyataz kien oriġinarjament awtorizzat f ’ ‘ Ċirkostanzi ta ’ Eċċezzjoni ’ minħabba raġunijiet xjentifiċi ma kienx possibbli li tinkiseb informazzjoni sħiħa dwar il- mediċina.
As the company had supplied the additional information requested, the ‘ Exceptional Circumstances ’ ended on 25 July 2008.
Minħabba li l- kumpanija tat l - informazzjoni addizzjonali mitluba, iċ - ‘ Ċirkostanzi ta ’ Eċċezzjoni ’ waqfu fil- 25 ta ’ Lulju 2008.
2/ 3 Other information about Reyataz:
2/ 3 Tagħrif ieħor dwar Reyataz:
The European Commission granted a marketing authorisation valid throughout the European Union for Reyataz to Bristol-Myers Squibb Pharma EEIG on 2 March 2004.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fis- suq valida madwar l- Unjoni Ewropea kollha, għal Reyataz lil Bristol- Myers Squibb Pharma EEIG fit- 2 ta ’ Marzu 2004.
The marketing authorisation was renewed on 2 March 2009.
L- awtorizzazzjoni għat- tqegħid fis- suq iġġedded fit- 2 ta ’ Marzu 2009.
The full EPAR for Reyataz can be found here.
L- EPAR sħiħ għal Reyataz jista ’ jiġi kkonsultat hawn.
Content
Kontenut (konċentr azzjoni)
Capsule, hard Capsule, hard Capsule, hard Capsule, hard Capsule, hard Capsule, hard
Kapsula, iebsa Kapsula, iebsa Kapsula, iebsa Kapsula, iebsa Kapsula, iebsa Kapsula, iebsa
Oral use Oral use Oral use Oral use Oral use Oral use
Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali
bottle (HDPE) blister (alu/ alu) bottle (HDPE) blister (alu/ alu) bottle (HDPE) blister (alu/ alu)
flixkun (HDPE) folja (alu/ alu) flixkun (HDPE) folja (alu/ alu) flixkun (HDPE) folja (alu/ alu)
60 capsules 60 capsules 60 capsules 60 capsules 60 capsules 60 capsules
60 kapsula 60 kapsula 60 kapsula 60 kapsula 60 kapsula 60 kapsula
Oral powder Capsule, hard Capsule, hard Capsule, hard
Trab orali Kapsula, iebsa Kapsula, iebsa Kapsula, iebsa
bottle (HDPE) bottle (HDPE) blister (alu/ alu) 3 bottles (HDPE)
flixkun (HDPE) flixkun (HDPE) folja (Alu/ Alu) 3 fliexken (HDPE)
1 bottle 30 capsules 30 capsules 30 capsules
1 flixkun 30 kapsula 30 kapsula 30 kapsula
REYATAZ 100 mg hard capsules
REYATAZ 100 mg kapsuli iebsin.
Each capsule contains 100 mg of atazanavir (as sulphate)
Kull kapsula fiha 100 mg ta 'atazanavir (bħala sulfat)
54.79 mg of lactose per capsule.
54, 79 mg ta 'lactose kull kapsula.
Hard capsule Opaque blue and white capsule printed with white and blue inks, with "BMS 100 mg" on one half and with "3623" on the other half.
Kapsula iebsa Kapsula opaka blu u bajda stampata b’ inka bajda u blu, b ’ "BMS 100 mg" fuq nofs u b ’ "3623" fuq in - nofs l- ieħor.
4.1 Therapeutic indications
Indikazzjonijiet Terapewtiċi
REYATAZ is indicated for the treatment of HIV-1 infected adults in combination with other antiretroviral medicinal products.
REYATAZ jingħata bħala kura lil pazjenti adulti infettati b’ HIV- 1 flimkien ma ’ prodotti mediċinali antiretrovirali oħra.
In antiretroviral treatment experienced patients, the demonstration of efficacy is based on a study comparing REYATAZ 300 mg once daily in combination with ritonavir 100 mg once daily with lopinavir/ ritonavir, each regimen in combination with tenofovir (see sections 4.8 and 5.1).
F’ pazjenti li ħadu kura antiretrovirali, it- turija ta ’ l- effikaċja hija bbażata fuq studju li jqabbel REYATAZ 300 mg darba kuljum flimkien ma ’ ritonavir 100 mg darba kuljum ma ’ lopinavir/ ritonavir, f’ kull każ mogħti flimkien ma ’ tenofovir (ara sezzjonijiet 4. 8 u 5. 1).
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, m' hu mistenni ebda benefiċċju f' pazjenti b' razez reżistenti għall- inibituri ta 'proteasi multipliċi (≥ 4 mutazzjonijet PI).
The choice of REYATAZ in treatment experienced patients should be based on individual viral resistance testing and the patient’ s treatment history (see section 5.1).
L- għażla ta ’ REYATAZ f’ pazjenti li diġà ħadu l- kura għandha tkun ibbażata fuq il- prova tar- reżistenza virali ta 'l- individwu u l- istorja tal- kura kollha li diġà ħa l- pazjent (ara sezzjoni 5. 1).
4.2 Posology and method of administration
4. 2 Pożoloġja u metodu ta ’ kif għandu jingħata
Therapy should be initiated by a physician experienced in the management of HIV infection.
It- terapija għandha tibda tingħata minn tabib li għandu esperjenza fil- kura ta ’ l- infezzjoni HIV.
Adults: the recommended dose of REYATAZ is 300 mg once daily taken with ritonavir 100 mg once daily and with food.
Adulti: id- doża rakkomandata ta ’ REYATAZ hija ta ’ 300 mg darba kuljum flimkien ma ’ ritonavir 100 mg darba kuljum ma ’ l- ikel.
Ritonavir is used as a booster of atazanavir pharmacokinetics (see sections 4.5 and 5.1).
Ritonavir jingħata biex isaħħaħ il- qawwa farmakokinetika ta ’ atazanavir (ara sezzjonijiet 4. 5 u 5. 1).
If REYATAZ with ritonavir is co-administered with didanosine, it is recommended that didanosine be taken 2 hours after REYATAZ with ritonavir.
Jekk REYATAZ flimkien ma ’ ritonavir jingħata wkoll flimkien ma ’ didanosine, huwa rrakkomandat li didanosine jingħata sagħtejn wara REYATAZ flimkien ma ’ ritonavir.
REYATAZ with ritonavir must be taken with food (see section 4.5).
REYATAZ flimkien ma ’ ritonavir għandu jittieħed ma ’ l- ikel (ara sezzjoni 4. 5).
Infants, toddlers, children, and adolescents: the safety and efficacy of REYATAZ in paediatric patients has not been established (see section 5.2).
Trabi, toddlers, tfal u addoloxxenti: is- sigurtà u l- effikaċja ta ’ REYATAZ f’ pazjenti pedjatriċi ma ġietx stabbilita (ara sezzjoni 5. 2).
Patients with renal impairment: no dosage adjustment is needed (see section 5.2).
Pazjenti b’ indeboliment renali: m’ hemmx bżonn ta ’ aġġustament fid- dożaġġ (ara sezzjoni 5. 2).
Patients with hepatic impairment:
Pazjenti b ’ indeboliment tal- fwied:
REYATAZ with ritonavir has not been studied in patients with hepatic impairment.
REYATAZ ma ’ ritonavir ma ġiex studjat f’ pazjenti f’ indeboliment tal- fwied.
REYATAZ with ritonavir should be used with caution in patients with mild hepatic impairment.
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).
2 Method of administration: for oral administration.
2 Kif jingħata: jittieħed mill- ħalq.
The capsules should be swallowed whole.
Il- pazjent irid jibla ’ l- kapsuli sħaħ.
REYATAZ oral powder is available for patients who are unable to swallow capsules (see Summary of Product Characteristics for REYATAZ oral powder).
REYATAZ trab orali huwa disponibbli għal pazjenti li ma jistgħux jibilgħu kapsuli (ara s- Sommarju tal- Karatteristiċi tal- Prodott għal REYATAZ trab orali).
Patients with moderate to severe hepatic insufficiency (see sections 4.2 and 4.4).
Pazjenti b’ indeboliment epatiku minn moderat għal sever (ara sezzjonijiet 4. 2 u 4. 4).
Combination of rifampicin and REYATAZ with concomitant low-dose ritonavir is contraindicated (see section 4.5).
Il- kombinazzjoni ta ’ rifampicin u REYATAZ flimkien ma ’ ritonavir ta ’ doża baxxa konkomittanti hija kontro- indikata (ara sezzjoni 4. 5).
REYATAZ with ritonavir must not be used in combination with medicinal products that are substrates of the CYP3A4 isoform of cytochrome P450 and have narrow therapeutic windows (e. g., astemizole, terfenadine, cisapride, pimozide, quinidine, bepridil, triazolam, midazolam administered orally (for caution on parenterally administered midazolam, see section 4.5), and ergot alkaloids, particularly, ergotamine, dihydroergotamine, ergonovine, methylergonovine) (see section 4.5).
REYATAZ ma 'ritonavir m’ għandux jintuża kombinat ma ’ prodotti mediċinali li huma sottoratti ta' isoform CYP3A4 ta 'cytochrome P450 u li għandhom meded terawpetiċi dojoq (eż. astemizole, terfenadine, cisapride, pimozide, quinidine, bepridil, triazolam, midazolam mogħtija mill- ħalq (għal midazolam parenterali, ara sezzjoni 4. 5), u ergot alkaloids, b' mod partikolari ergotamine, dihydroergotamine, ergonovine, methylergonovine) (ara sezzjoni 4. 5).
REYATAZ must not be used in combination with products containing St.
REYATAZ m’ għandux jintuża flimkien ma ’ prodotti li għandhom St.
John’ s wort (Hypericum perforatum) (see section 4.5).
John’ s wort (Hypericum perforatum) (ara sezzjoni 4. 5).
Patients should be advised that current antiretroviral therapy has not been proven to prevent the risk of transmission of HIV to others through blood or sexual contact.
Il- pazjenti għandhom ikunu nfurmati li l- kura antiretrovirali kurrenti ma ġietx ippruvata li timpedixxi r- riskju ta ’ tixrid ta ’ HIV lill- oħrajn bid- demm jew permezz ta ’ kuntatt sesswali.
Appropriate precautions should continue to be employed.
Għallhekk għandhom ikomplu jittieħdu prekawzjonijiet xierqa.
Co-administration of REYATAZ with ritonavir in doses greater than 100 mg once daily has not been clinically evaluated.
L- użu ta ’ REYATAZ flimkien ma ’ ritonavir f’ dożi ta ’ iktar minn 100 mg darba kuljum ma ġiex evalwat klinikament.
The use of higher ritonavir doses might alter the safety profile of atazanavir (cardiac effects, hyperbilirubinaemia) and therefore is not recommended.
L- użu ta ’ dożi ogħla ta ’ ritonavir jista ’ jbiddel il- profil totali tas- sigurtà ta ’ atazanavir (effetti kardijaċi, iperbilirubinemja) u għalhekk mhux irrikkmandat li jingħata.
Patients with coexisting conditions Atazanavir is primarily hepatically metabolised and increased plasma concentrations were observed in patients with hepatic impairment (see sections 4.2 and 4.3).
Pazjenti b' kondizzjonijiet ko- eżistenti Atazanavir huwa primarjament metabolizzat mill- fwied u żidiet fil- konċentrazzjoni tal- plażma ġew osservati f’ pazjenti b’ indeboliment tal- fwied (ara sezzjonijiet 4. 2 u 4. 3).
The safety and efficacy of REYATAZ has not been established in patients with significant underlying liver disorders.
Is- sigurtà u l- effikaċja ta ’ REYATAZ ma ġewx stabbiliti f’ pazjenti b' mard tal- fwied preżenti sinifikanti.
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 Ċ u kkurati b’ taħlita ta ’ terapija antiretrovirali għandhom iktar riskju ta ’ reazzjonijiet avversi, epatiċi severi 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).
Patients with pre-existing liver dysfunction, including chronic active hepatitis, have an increased frequency of liver function abnormalities during combination antiretroviral therapy and should be monitored according to standard practice.
Pazjenti li diġà jbatu minn mard tal- fwied, inkluż epatite attiva kronika, jista ’ jkollhom anormalitajiet fil- funzjoni tal- fwied aktar spiss waqt taħlita ta ’ terapija antiretrovirali u għandhom jiġu ċċekjati skond il- prattika stabbilita.
If there is evidence of worsening liver disease in such patients, interruption or discontinuation of treatment must be considered.
Jekk ikun hemm xi evidenza li l- marda tal- fwied qed tiggrava f’ dawn il- pazjenti, it- twaqqif jew l- interruzzjoni tal- kura għandu jiġi kkunsiderat.
Dose related asymptomatic prolongations in PR interval with REYATAZ have been observed in clinical studies.
Fi studji kliniċi ġie osservat titwil mingħajr sintomi fl- intervall ta ’ PR bi REYATAZ.
Caution should be used with medicinal products known to induce PR prolongations.
Prodotti mediċinali li huma magħrufa li jikkaġunaw titwil ta ’ PR għandhom jintużaw b’ attenzjoni.
In patients with pre-existing conduction problems (second degree or higher atrioventricular or complex bundle-branch block), REYATAZ should be used with caution and only if the benefits exceed the risk (see section 5.1).
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).
Għandha tingħata attenzjoni partikulari meta REYATAZ ikun preskritt flimkien ma '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).
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.
3 addizzjonali.
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 rrapportati, il- kura b’ inibituri ta ’ proteasi tkompliet jew reġgħet bdiet jekk kienet twaqqfet.
A causal relationship has been suggested, although the mechanism of action has not been elucidated.
Ġiet osservata xi konnessjoni każwali għalkemm ma kienx spjegat kif taħdem.
Haemophiliac patients should therefore be made aware of the possibility of increased bleeding.
Għalhekk pazjenti li jbatu minn emofilja għandhom jiġu infurmati li jista ’ jkollhom aktar emorraġija.
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 disturbi metaboliċi Terapija kombinata antiretrovirali ġiet assoċjata ma ’ ri- distribuzzjoni ta ’ xaħam fil- ġisem (lipodistrofija) f’ pazjenti bl- HIV.
The long-term consequences of these events are currently unknown.
Il- konsegwenzi fit- tul ta ’ dawn l- episodji bħalissa għadhom mhux magħrufa.
Knowledge about the mechanism is incomplete.
Għad m’ hemmx tagħrif komplet fuq il- mekkaniżmu.
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.
Combination antiretroviral therapy (CART), including REYATAZ (with or without ritonavir)-based CART, is associated with dyslipidaemia.
Terapija antiretrovirali ta ’ kombinazzjoni (CART), li tinkludi CART ibbażata fuq REYATEZ (bi jew mingħajr ritonavir), hija assoċjata ma ’ dislipidemija.
Consideration should be given to the measurement of fasting serum lipids and blood glucose.
Għandu jiġi kkunsidrat il- livell tal- lipidi fis - serum waqt is- sawm u tal- glucose fid- demm.
Lipid disorders should be managed as clinically appropriate (see section 4.8).
Disturbi tal- lipidi għandhom jiġu kkurati kif inhi n - norma klinika (ara sezzjoni 4. 8).
In clinical studies, REYATAZ (with or without ritonavir) has been shown to induce dyslipidaemia to a lesser extent than comparators.
Minn studji kliniċi sar magħruf li REYATAZ (ma ’ jew mingħajr ritonavir) jikkaġuna dislipidemja inqas qawwija minn mediċini li tqabbel magħhom.
The clinical impact of such findings has not been demonstrated in the absence of specific studies on cardiovascular risk.
L- impatt kliniku ta ’ dawn ir- riżultati ma ġiex ipprovat minħabba li ma sarux studji speċifiċi fuq riskju kardjovaskulari.
The selection of antiretroviral therapy must be guided principally by antiviral efficacy.
L- għażla ta ’ terapija antiretrovirali għandha tkun iggwidata prinċipalment mill- effikaċja antivirali.
Consultation with standard guidelines for management of dyslipidaemia is recommended.
Il- konsultazzjoni ma ’ linji gwida standard għall- ġestjoni ta ’ dislipidemja hija rakkomandata.
Hyperglycaemia New onset diabetes mellitus, hyperglycaemia, and exacerbation of existing diabetes mellitus have been reported in patients receiving protease inhibitors.
Ipergliċemija Ġie osservat li f’ pazjenti li kienu qed jieħdu inibituri proteasi kien hemm każi ġodda ta ’ dijabete mellitus, ipergliċemija, u f’ każi li l- pazjenti kellhom diġà d- dijabete saret iktar qawwija.
In some of these, the hyperglycaemia was severe and in some cases also associated with ketoacidosis.
F’ xi wħud minn dawn l- ipergliċemija kienet qawwija u f’ xi każi kienet anki assoċjata ma ketoaċidosi.
Many patients had confounding medical conditions, some of which required therapy with medicinal products that have been associated with development of diabetes or hyperglycaemia.
Ħafna pazjenti kellhom kundizzjonijiet mediċi mħawwdin fejn xi ftit minnhom kellhom bżonn ta ’ terapija b’ mediċini oħra li huma assoċjati ma ’ l- iżvilupp tad- dijabete jew ipergliċemija.
Hyperbilirubinaemia Reversible elevations in indirect (unconjugated) bilirubin related to inhibition of UDP-glucuronosyl transferase (UGT) have occurred in patients receiving REYATAZ (see section 4.8).
Iperbilirubinemja Kien hemm livelli għolja riversibbli fil- bilirubin indirett (mhux konjugat) assoċjati ma ’ l- inbizzjoni tal- UDP- glucuronosil transferasi (UGT) f’ pazjenti li ħadu REYATAZ (ara sezzjoni 4. 8).
Hepatic transaminase elevations that occur with elevated bilirubin in patients receiving REYATAZ should be evaluated for alternative etiologies.
Għandhom jiġu kkonsidrati, etjoloġiji alternattivi f’ pazjenti li jieħdu REYATAZ, jekk il- pazjenti jkollhom żieda fit- transaminase tal- fwied assoċjati ma ’ bilirubin għoli.
Alternative antiretroviral therapy to REYATAZ may be considered if jaundice or scleral icterus is unacceptable to a patient.
Tista ’ tiġi kkunsidrata terapija antiretrovirali oħra minflok REYATAZ jekk is- suffejra jew ikterus sklerali ma jkunux aċċettabbli għal pazjent.
Dose reduction of atazanavir is not recommended because it may result in a loss of therapeutic effect and development of resistance.
M’ għandiex titnaqqas id- doża ta ’ atazanavir għax dan jista ’ jikkaġuna nuqqas fl- effett terapewtiku u fl- iżvilupp ta ’ reżistenza.
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.
Combinations of REYATAZ and indinavir have not been studied and co-administration of these medicinal products is not recommended (see section 4.5).
Taħlita ta ’ terapija ta ’ REYATAZ u indinavir ma ġietx studjata u l- użu taż- żewġ mediċini flimkien mhux irrikmandat (ara sezzjoni 4. 5).
Nephrolithiasis Nephrolithiasis has been reported in patients receiving REYATAZ (see section 4.8).
Ġiet irrapportata nefrolitjasi f’ pazjenti li jirċievu REYATAZ (ara sezzjoni 4. 8).
If signs or symptoms of nephrolithiasis occur, temporary interruption or discontinuation of treatment may be considered.
Jekk iseħħu sinjali jew sintomi ta ’ nefrolitjasi, għandha tiġi kkunsidrata interruzzjoni temporanja jew inkella waqfien tal- kura.
Immune reactivation syndrome In HIV-infected patients with severe immune deficiency at the time of institution of combination antiretroviral therapy (CART), an inflammatory reaction to asymptomatic or residual opportunistic pathogens may arise and cause serious clinical conditions, or aggravation of symptoms.
Sindrome ta 'riattivazzjoni ta' l- immunità F' pazjenti infettati bl- HIV b' defiċjenza immunitarja gravi meta jkunu qed jieħdu taħlita ta 'terapija antiretrovirali (CART), tista' tkun ikkaġunata reazzjoni ta 'infjammazzjoni għal patoġeni bla sintomi jew dawk opportunistiċi residwali u din tista' tikkaġuna kundizzjonijiet kliniċi serji, jew aggravar tas - sintomi.
Typically, such reactions have been observed within the first few weeks or months of initiation of CART.
Tipikament, tali reazzjonijiet kienu osservati fl- ewwel ġimgħat jew xhur minn meta nbdiet il - CART.
4 Relevant examples are cytomegalovirus retinitis, generalised and/ or focal mycobacterial infections, and Pneumocystis carinii pneumonia.
4 mikobatteriċi ffukati, u Pneumocystis carinii pneumonia.
Any inflammatory symptoms should be evaluated and treatment instituted when necessary.
Kull sintomu ta 'infjammazzjoni għandu jiġi evalwat u għandha tinbeda kura meta jkun hemm bżonnha.
Osteonecrosis Although the etiology is considered to be multifactorial (including corticosteroid use, alcohol consumption, severe immunosuppression, higher body mass index), cases of osteonecrosis have been reported particularly in patients with advanced HIV-disease and/ or long-term exposure to combination antiretroviral therapy (CART).
Ostjonekrosi Għalkemm l- etjoloġija hi kkunsidrata li hi minn ħafna fatturi (inklużi użu ta 'corticosteroid, konsum ta' alkoħol, immunosoppressjoni gravi, indiċi tal- massa tal- ġisem ogħla), każi ta 'ostjonekrosi ġew irrappurtati b' mod partikulari f' pazjenti bil- marda ta' l- HIV avvanzata u/ jew espożizzjoni fit- tul għat - terapija antiretrovirali mħallta (CART).
Patients should be advised to seek medical advice if they experience joint aches and pain, joint stiffness or difficulty in movement.
Il- pazjenti għandhom ikunu avżati sabiex ifittxu parir mediku jekk iħossu xi uġigħ fil- ġogi, ebusija fil- ġogi jew diffikultà biex jiċċaqilqu.
Interactions with other medicinal products Co-administration of REYATAZ with simvastatin or lovastatin is not recommended (see section 4.5).
Prodotti mediċinali li ma jaqblux ma ’ din il- mediċina REYATAZ m’ għandux jingħata ma ’ simvastatin jew ma ’ lovastatin (ara sezzjoni 4. 5).
Co-administration of REYATAZ with nevirapine or efavirenz is not recommended (see section 4.5).
L- għoti fl- istess ħin ta ’ REYATAZ ma ’ nevirapine jew efavirenz mhuwiex rakkomandat (ara sezzjoni 4. 5).
If the coadministration of REYATAZ with an NNRTI is required, an increase in the dose of both REYATAZ and ritonavir to 400 mg and 200 mg, respectively, in combination with efavirenz could be considered with close clinical monitoring.
Jekk l- għoti fl- istess ħin ta ’ REYATAZ ma ’ NNRTI ikun meħtieġ, tista ’ tkun meħtieġa żieda fid- doża kemm ta ’ REYATAZ kif ukoll ta ’ ritonavir għal 400 mg u 200 mg, rispettivament, f’ kombinazzjoni ma ’ efavirenz b’ monitoraġġ kliniku mill- qrib.
Atazanavir is metabolised principally by CYP3A4.
Atazanavir huwa prinċipalment metabolizzat minn CYP3A4.
Co-administration of REYATAZ with ritonavir and medicinal products that induce CYP3A4 is not recommended (see sections 4.3 and 4.5).
L- użu ta ’ REYATAZ flimkien ma ’ ritonavir u mediċinali oħra li jistimulaw CYP3A4 mhux irrikmandat (ara sezzjonijiet 4. 3 u 4. 5).
The concomitant use of REYATAZ and oral contraceptives should be avoided (see section 4.5).
L- użu ta ’ REYATAZ flimkien ma 'kontraċettivi orali għandu jiġi evitat (ara sezzjoni 4. 5).
Co-administration of voriconazole and REYATAZ with ritonavir is not recommended unless an assessment of the benefit/ risk justifies the use of voriconazole (see section 4.5).
L- għoti fl- istess ħin ta ’ voriconazole u REYATAZ ma ’ ritonavir mhuwiex rakkomandat sakemm stima tal- benefiċċji/ riskji ma tkunx tiġġustifika l- użu ta ’ voriconazole (ara sezzjoni 4. 5).
Concomitant use of REYATAZ/ ritonavir and fluticasone or other glucocorticoids that are metabolized by CYP3A4 is not recommended unless the potential benefit of treatment outweighs the risk of systemic corticosteroid effects, including Cushing's syndrome and adrenal suppression (see section 4.5).
L- użu flimkien ta 'REYATAZ/ ritonavir u fluticasone jew glucocorticoids oħra li huma metabolizzati b' CYP3A4 mhux rakkomandat sakemm il- benefiċċju mistenni ma jkunx akbar mir- riskju ta' l- effetti sistematiċi ta 'corticosteroid, inkluż is- sindrome ta' Cushing u t- trażżin adrenali (ara sezzjoni 4. 5).
The absorption of atazanavir may be reduced in situations where gastric pH is increased irrespective of cause.
L- assorbiment ta 'atazanavir jista' jonqos f' sitwazzjonijiet fejn il- pH fl- istonku jiżdied irrespettivament mill- kawża.
Co-administration of REYATAZ with proton pump inhibitors is not recommended (see section 4.5).
Amministrazzjoni fl- istess ħin ta ’ REYATAZ ma ’ inibituri proton pump m’ hijiex rakkomandata (ara sezzjoni 4. 5).
If the combination of REYATAZ with a proton pump inhibitor is judged unavoidable, close clinical monitoring is recommended in combination with an increase in the dose of REYATAZ to 400 mg with 100 mg of ritonavir; doses of proton pump inhibitors comparable to omeprazole 20 mg should not be exceeded.
Jekk il- kombinazzjoni ta ’ REYATAZ ma ’ inibitur proton pump titqies bħala waħda inevitabbli, monitoraġġ kliniku mill- qrib huwa rakkomandat f’ kombinazzjoni ma ’ żieda fid- doża ta ’ REYATAZ ta ’ 400 mg ma ’ 100 mg ta ’ ritonavir; id- dożi ta ’ inibituri proton pump komparabbli ma ’ omeprazole 20 mg ma għandhomx jinqabżu.
Lactose Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
Lactose Pazjenti bi problemi ereditarji rari ta ’ intolleranza għal galactose, defiċjenza Lapp lactase jew assorbiment ħażin ta ’ glucose- galactose m’ għandhomx jingħataw dan il- prodott mediċinali.
When REYATAZ and ritonavir are co-administered, the metabolic drug interaction profile for ritonavir may predominate because ritonavir is a more potent CYP3A4 inhibitor than atazanavir.
Meta REYATAZ u ritonavir jingħataw flimkien, il- profil metaboliku ta 'interazzjoni ta ’ ritonavir jista ’ jippredomina għax ritonavir huwa inibitur ta ’ CYP3A4 iktar qawwi minn atazanavir.
The Summary of Product Characteristics for ritonavir must be consulted before initiation of therapy with REYATAZ and ritonavir.
Qabel ma tinbeda terapija ta ’ REYATAZ ma ’ ritonavir wieħed għandu jaqra s- Sommarju tal- Karatteristiċi tal - Prodott għal ritonavir.
Atazanavir is metabolised in the liver through CYP3A4.
Atazanavir jiġi metabolizzat fil- fwied permezz ta ’ CYP3A4.
It inhibits CYP3A4.
Jinibixxi l- CYP3A4.
Therefore, REYATAZ with ritonavir is contraindicated with medicinal products that are substrates of CYP3A4 and have a narrow therapeutic index: astemizole, terfenadine, cisapride, pimozide, quinidine, bepridil, triazolam, orally administered midazolam, and ergot alkaloids, particularly ergotamine and dihydroergotamine (see section 4.3).
Għalhekk, REYATAZ flimkien ma ’ ritonavir huwa kontra- indikat ma ’ prodotti mediċinali li huma sottosratti ta ’ CYP3A4 u għandhom indiċi terapewtiku limitat: astemizole, terfenadine, cisapride, pimozide, quinidine, bepridil, triazolam, midazolam mogħti mill- ħalq, u alkalojdi ergot, partikolarment ergotamine u dihydroergotamine (ara sezzjoni 4. 3).
5 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”).
5 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 ”).
If available, 90% confidence intervals (CI) are shown in parentheses.
Jekk ikunu disponibbli, intervalli ta 'kunfidenza ta' 90% (CI) jiġu murija f' parentesi.
The studies presented in Table 1 were conducted in healthy subjects unless otherwise noted.
L- istudji ppreżentati f' Tabella 1 saru f' individwi b' saħħithom sakemm mhux innotat mod ieħor.
Of importance, many studies were conducted with unboosted atazanavir, which is not the approved regimen of atazanavir.
Importanti, ħafna studji saru b' atazanavir mhux imsaħħaħ, li mhuwiex ir - reġim approvat ta 'atazanavir.
Interactions between REYATAZ and other medicinal products
Interazzjonijiet bejn REYATAZ u prodotti mediċinali oħra
Co-administered medicinal
Prodotti mediċinali mogħtija Prodott
Recommendations
Rakkomandazzjonijie
products (dose in mg)
fl- istess ħin (doża f’ mg)
product assessed
mediċinali evalwat
co-administration
t dwar l- għoti fl- istess ħin
ANTI-INFECTIVES Antiretrovirals Protease inhibitors:
ANTI- INFETTIVI Antiretrovirali Inibituri protease:
The co-administration of REYATAZ/ ritonavir and other protease inhibitors has not been studied but would be expected to increase exposure to other protease inhibitors.
L- għoti fl- istess ħin ta 'REYATAZ/ ritonavir u inibituri protease oħra ma ġiex studjat iżda huwa mistenni li jżid l - esponiment għal inibituri protease oħra.
Therefore, such co-administration is not recommended.
Għaldaqstant, tali għoti fl- istess ħin mhuwiex rakkomandat.
(atazanavir 300 mg QD)
(atazanavir 300 mg QD) studji
daily is used as a
darba kuljum jintuża
studies conducted in HIV- infected patients
mwettqa fuq pazjenti infettati bl- HIV
booster of atazanavir pharmacokinetics.
bħala tqawwija tal - farmakokinetiċi ta '
* In a combined analysis, atazanavir 300 mg and ritonavir 100 mg (n=33) was compared to atazanavir 400 mg without ritonavir (n=28).
* Fi studju kkombinat, atazanavir 300 mg u ritonavir 100 mg (n=33) ġie pparagunat ma 'atazanavir 400 mg mingħajr ritonavir (n=28).
The mechanism of interaction between atazanavir and ritonavir is CYP3A4 inhibition.
Il- mekkaniżmu ta 'interazzjoni bejn atazanavir u ritonavir huwa l - inibizzjoni ta' CYP3A4.
Indinavir is associated with indirect unconjugated hyperbilirubinaemia due to inhibition of UGT.
Indinavir hu assoċjat ma 'iperbilirubinimja indiretta mhux konjugata minħabba l- inibizzjoni ta' UGT.
Coadministration of REYATAZ/ ritonavir and indinavir is not recommended (see section 4.4).
L- għoti flimkien ta ’ REYATAZ/ ritonavir u indinavir mhuwiex rakkomandat (ara sezzjoni 4. 4).
Nucleoside/ nucleotide reverse transcriptase inhibitors (NRTIs) Lamivudine 150 mg BID +
Nucleoside/ nucleotide reverse transcriptase inhibitors (NRTIs) Lamivudine 150 mg BID + zidovudine 300 mg BID
Based on these data
Fuq il- bażi ta 'din l - informazzjoni u
No significant effect on lamivudine and zidovudine concentrations was observed.
lamivudine u zidovudine.
and because ritonavir is not expected to have a significant impact on the pharmacokinetics of NRTIs, the co-administration of REYATAZ/ ritonavir with these medicinal products is not expected to significantly alter the exposure of the co- administered drugs.
minħabba li ritonavir mhuwiex mistenni li jkollu impatt sinifikanti fuq il- farmakokinetiċi tan- NRTIs, l- għoti fl - istess ħin ta 'REYATAZ/ ritonavir ma' dawn il- prodotti mediċinali mhux mistenni li jbiddel b' mod sinifikanti l - esponiment tal - mediċini mogħtija fl - istess ħin.
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 mistenni li jibdel b' mod sinifikanti l- esponiment ta 'abacavir.
Didanosine (buffered tablets) 200 mg/ stavudine 40 mg, both single dose (atazanavir 400 mg
Didanosine (pilloli bafferjati) 200 mg/ stavudine 40 mg, it - tnejn dożi singoli (atazanavir 400 mg doża waħda)
atazanavir, simultaneous ↓ 0.13 ↓ 0.11 ↓ 0.16 administration
atazanavir, għoti fl- istess ħin ma '↓0. 13 ↓0. 11 ↓0. 16 ddI+d4T (fuq (0. 08, 0. 21) (0. 06, 0. 18) (0. 10, 0. 27) stonku vojt) atazanavir, mogħti siegħa wara ↔1. 03 ↑1. 12 ↔1. 03 (0. 64, 1. 67) (0. 67, 1. 18) (0. 61, 1. 73) ddI+d4T (fuq stonku vojt)
REYATAZ/ ritonavir taken with food.
Didanosine għandu jittieħed fuq stonku vojt sagħtejn wara t - teħid ta 'REYATAZ/ ritonavir ma' l- ikel.
The co-administration of
L- għoti fl - istess ħin ta 'REYATAZ/ ritonavir ma' stavudine mhuwiex mistenni li jibdel b' mod sinifikanti l- esponiment ta '
(0.08, 0.21) (0.06, 0.18) (0.10, 0.27) with ddI+d4T
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