qanastek/EMEA-V3 huggingface dataset:
Always take Corlentor exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
Dejjem għandek taċċerta ruħek mat- tabib jew ma ’ l- ispiżjar tiegħek jekk ikollok xi dubju.
The usual recommended starting dose is 1 tablet of Corlentor 5 mg twice daily increasing if necessary to 1 tablet of Corlentor 7.5 mg twice daily.
Id- doża li ssoltu tingħata fil- bidu hija ta ’ pillola waħda ta ’ Corlentor 5 mg darbtejn kuljum u tiżdied jekk ikun hemm bżonn għall - 1 pillola ta ’ Corlentor 7. 5 mg darbtejn kuljum.
Your doctor will decide the right dose for you.
It- tabib jagħzel id- doża tajba għalik.
The usual dose is one tablet in the morning and one tablet in the evening.
Is- soltu d- doża tkun ta ’ pillola waħda fil- għodu u pillola waħda fil- għaxija.
In some cases (e. g. if you are elderly), your doctor may prescribe half the dose i. e., one half 5 mg tablet of Corlentor 5 mg (corresponding to 2.5 mg ivabradine) in the morning and one half 5 mg tablet in the evening.
F’ xi każijiet (eż. jekk int anzjan/ a) it- tabib tiegħek jista ’ jagħtik nofs id - doża i. e. nofs pinnola Corlentor 5 mg (li hija 2. 5 mg ivabradine) fil- għodu u nofs pillola 5 mg fil - għaxija.
Corlentor should be taken during meals.
Corlentor irid jittieħed ma ’ l- ikel.
If you think that the effect of Corlentor is too strong or too weak, talk to your doctor or pharmacist.
Jekk taħseb li l- effett ta ’ Corlentor hu qawwi ħafna jew ħafif wisq, kellem lit- tabib jew lill- ispiżjar tiegħek.
Corlentor is not intended for use in children and adolescents younger than 18 years.
Corlentor mhux qiegħed għall- użu tat- tfal u żagħżagħ taħt it- 18 – il sena.
A large dose of Corlentor could make you feel breathless or tired because your heart slows down too much.
Jekk tieħu Corlentor aktar milli suppost B’ doża kbira ta ’ Corlentor tista ’ tħossok b’ nifsek maqtugħ jew għajjien għax il- qalb tħabbat iktar bil - mod.
If this happens, contact your doctor immediately.
Jekk jiġri hekk għarraf lit- tabib tiegħek immedjat.
If you forget to take a dose of Corlentor, take the next dose at the usual time.
Jekk tinsa tieħu Corlentor Jekk tinsa tieħu d- doża ta ’ Corlentor, ħu d- doża normali meta jkun jerġa ’ jmissek.
Do not take a double dose to make up for the forgotten dose.
M’ għandekx tieħu doża doppja biex tpatti għal kull doża li tkun insejt tieħu.
The calendar printed on the blister containing the tablets should help you remember when you last took a tablet of Corlentor.
Il- ġranet stampati fuq il- folja li fiha l- pilloli jistgħu jgħinuk biex tiftakar meta ħadt l- aħħar pillola ta ’ Corlentor.
As the treatment for angina is usually life-long, you should discuss with your doctor before stopping this medicinal product.
Jekk tieqaf tieħu Corlentor Minħabba li din il- kura għall- anġina hija normalment għal- għomrok, int għandek titkellem mat- tabib tiegħek qabel ma twaqqaf dan il- prodott mediċinali.
Like all medicines, Corlentor can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, Corlentor jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
Very common side effects (more than 1 in 10 patients) reported with Corlentor are luminous visual phenomena (brief moments of increased brightness, most often caused by sudden changes in light intensity).
Effetti sekondarji komuni ħafna ta ’ Corlentor (iktar minn 1 f ’ kull 10 pazjenti) huma fenomeni mudwali viżivi (perjodi qosra ta ’ dija qawwija ħafna drabi minħabba tibdil f’ daqqa fil- qawwa tad - dawl).
Other common side effects (more than 1 in 100 patients but less than 1 in 10 patients) include affecting the way the heart works (the symptoms are a slowing down of the heart rate), headache, dizziness, blurred vision and palpitations and cardiac extra beats which are uncommon (more than 1 in 1000 patients but less than 1 in 100 patients).
Effetti sekondarji oħra komuni (iktar minn 1 f’ kull 100 pazjent iżda inqas minn 1 f’ kull 10 pazjenti) jinkludu effetti kif taħdem il- qalb (is- sintomi huma li r- rata tat- taħbit tal- qalb tibda tonqos), uġigħ ta ’ ras, sturdament, vista imċajpra u taħbit mgħaġġel tal- qalb u meta l- qalb tagħmel taħbit żejjed li m’ humiex komuni (iktar minn 1 f’ kull 1000 pazjent iżda inqas minn 1 f’ kull 100 pazjent).
Also nausea, constipation, diarrhoea, vertigo, dyspnoea, muscle cramps and changes in laboratory parameters (blood tests) were reported uncommonly.
Ġew rapportati mhux komuni ukoll dardir, stitikezza, dijarea, vertigo, qtugħ ta ’ nifs u bugħawwieg u tibdiliet fil- parametri tal- laboratorju (testijiet tad- demm).
If any of the side effects gets serious of if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Jekk xi wieħed mill- effetti sekondarji jiggrava jew jekk tinnota xi effetti sekondarji li mhumiex imsemmijin f’ dan il- fuljett, jekk jogħġbok, għid lit- tabib jew lill- ispiżjar tiegħek.
HOW TO STORE CORLENTOR
KIF TAĦŻEN CORLENTOR
This medicinal product does not require any special storage conditions.
Din il- mediċina m’ għandiex bżonn ħażna speċjali.
Do not use Corlentor after the expiry date which is stated on the carton and blister.
Tużax Corlentor wara d- data ta ’ skadenza li tidher fuq il- kaxxa u il- folja.
The expiry date refers to the last day of that month.
Id- Data ta ’ skadenza tirreferi għal l- aħħar ġurnata ta ’ dak ix- xahar.
What Corlentor contains:
X’ fih Corlentor:
- The active substance is ivabradine (as hydrochloride).
- Is- sustanza attiva hi ivabradine (bħala hydrochloride)
Corlentor 7.5 mg: one film-coated tablet contains 7.5 mg ivabradine (equivalent to 8.085 mg ivabradine hydrochloride).
Corlentor 5 mg: pillola waħda miksija b’ rita fiha 5 mg ivabradine (ekwivalenti għal 5. 390 mg ivabradine hydrochloride) Corlentor 7. 5 mg: pillola waħda miksija b’ rita fiha 7. 5 mg ivabradine (ekwivalenti għal 8. 085 mg ivabradine hydrochloride)
- The other ingredients in the tablet core are: lactose monohydrate, magnesium stearate (E 470 B),
- Is- sustanzi l- oħra fil- qalba tal- pillola huma: lactose monohydrate, magnesium stearate (E 470 B),
maize starch, maltodextrin, colloidal anhydrous silica (E 551), and in the tablet coating: hypromellose (E 464), titanium dioxide (E 171), macrogol 6000, glycerol (E 422), magnesium stearate (E 470 B), yellow iron oxide (E 172), red iron oxide (E 172).
maize starch, maltodextrin, colloidal anhydrous silica (E 551), u fil- kisja tal- pillola: hypromellose (E 470), titanium dioxide (E 171), macrogol 6000, glycerol (E 422), magnesium stearate (E 470B), iron oxide isfar (E 172), iron oxide aħmar (E 172).
What Corlentor looks like and contents of the pack:
Id- dehra ta ’ Corlentor u l- kontenut tal- pakkett:
Corlentor 5 mg tablets are salmon-coloured, oblong film-coated tablets scored on both sides, engraved with “ 5 ” on one face and
Corlentor 5 mg pilloli huma kulur is- salamun, pilloli miksija b’ rita, oblungi, b’ sinjal imnaqqax fuq iż - żewġ naħat, fuq naħa waħda imnaqax b “ 5 ” u fuq in- naħa l- oħra
Corlentor 7.5 mg tablets are salmon-coloured, triangular, film-coated tablets engraved with “ 7.5 ” on one face and
Corlentor 7. 5 mg pilloli huma kulur is- salamun, triangulari, pilloli miksija b’ rita b’ sinjal fuq naħa waħda imnaqqax “ 7. 5 ” u fuq in- naħa l- oħra
The tablets are available in calendar packs (blisters) of 14, 28, 56, 84, 98, 100 or 112 tablets.
Il- pilloli jinsabu f’ pakketti (folji) ta ’ 14, 28, Mhux il- pakketti kollha jistgħu jinsabu fis- suq.
Not all pack sizes may be available.
56, 84, 98, 100 jew 112- il pillola immarkat bil- ġranet.
Marketing Authorisation Holder and Manufacturer:
Id- detentur ta ’ l- awtorizzazzjoni għat- tqegħid fis- suq u l- Manifattur:
Les Laboratoires Servier 22 rue Garnier 92200 Neuilly sur Seine - France
Id- detentur ta ’ l- awtorizzazzjoni għat- tqegħid fis- suq Les Laboratoires Servier 22 rue Garnier 92200 Neuilly sur Seine - France
Les Laboratoires Servier Industrie 905 route de Saran 45520 Gidy – France
Manifattur Les Laboratoires Servier Industrie 905 route de Saran 45520 Gidy – France
36 and
u
Wicklow – Ireland
Wicklow – Ireland
and Przedsiebiorstwo Farmaceutyczne ANPHARM S. A. ul.
36 Przedsiebiorstwo Farmaceutyczne ANPHARM S. A. ul.
Annopol 6B – 03-236 Warszawa – Poland
Annopol 6B – 03- 236 Warszawa – Poland
37 For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
37 Għal kull tagħrif dwar dan il- prodott mediċinali, jekk jogħġbok ikkuntattja lir- rappreżentant lokali tad - 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 /
EPAR summary for the public
Sommarju EPAR għall- pubbliku
If you need more information about your medical condition or your treatment, read the Package Leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Jekk teħtieġ aktar informazzjoni dwar il- kundizzjoni medika jew it- trattament tiegħek, aqra l - Fuljett ta ’ Illustrazzjoni (li jagħmel ukoll parti mill- EPAR) jew ikkuntattja t- tabib jew l- ispi¿ jar tiegħek.
If you want more information on the basis of the CHMP recommendations, read the Scientific Discussion (also part of the EPAR).
Jekk tixtieq aktar informazzjoni relatata mar- rakkomandazzjonijiet tas- CHMP, tista ’ taqra d- Diskussjoni Xjentifika (li tagħmel ukoll parti mill- EPAR).
What is Crixivan?
X’ inhu Crixivan?
Crixivan is a medicine containing the active substance indinavir.
Crixivan hija mediċina li fiha s- sustanza attiva indinavir.
It is available as white capsules (100, 200, 333 and 400 mg).
Hija disponibbli f’ kapsuli bojod li fihom (100, 200, 333 u 400 mg).
What is Crixivan used for?
Għal x' hiex jintuża Crixivan?
Crixivan is an antiviral medicine.
Crixivan huwa mediċina antivirali.
It is used in combination with other antiviral medicines to treat adults, adolescents and children aged over four years who are infected with human immunodeficiency virus type 1 (HIV-1), a virus that causes acquired immune deficiency syndrome (AIDS).
Huwa jintuża flimkien ma ’ mediċini antivirali oħra biex jiġu kkurati persuni adulti u tfal ta ’ ’ l fuq minn erba ’ snin li jkunu infettati bil- virus ta ’ l- immunodefiċjenza uman tat- tip 1 (HIV- 1), virus li jikkawża s- Sindrome ta 'immunodefiċjenza akkwiżita (AIDS).
In adolescents and children, the possible benefit of treatment with Crixivan should be weighed up against the increased risk of developing nephrolithiasis (kidney stones).
Il - benefiċċju potenzjali tat- trattament Crixivan f’ adoloxxenti u tfal għandu jiġi kkonsidrat meta mqabbel mar- riskju ogħla li tiżviluppa n- nefrolitiasis (ġebel fil- kliewi).
How is Crixivan used?
Kif jintuża Crixivan?
Treatment with Crixivan should be given by doctors who have experience in the treatment of HIV infection.
It- trattament bi Crixivan għandu jinbeda minn tabib li għandu esperjenza fit- trattament ta ’ infezzjonijiet ta ’ l- HIV.
Crixivan must be used in combination with other antiviral medicines.
Crixivan għandha tingħata f’ kombinazzjoni ma ’ mediċini antivirali oħra.
The standard dose for adults is 800 mg every eight hours.
Id - doża standard għal adulti hija ta ’ 800 mg kull 8 sigħat.
For children, the dose depends on the body surface area (calculated using the child ’ s height and weight).
Fil- każ ta ’ fjal, id- doża tiddependi miż- żona tal- wiċċ tal- ġisem (ikkalkolata permezz ta ’ l- użu tat- tul u l- piż tat- tifel/ tifla).
The capsules should be swallowed whole without food but with water one hour before or two hours after a meal.
Il- kapsuli għandhom jiġu miblugħa sħaħ bla ikel ma ’ l- ilma sigħa qabel jew sagħtejn wara ikla.
Alternatively, Crixivan may be given with a low-fat, light meal.
Inkella, Crixivan jista ’ jingħata ma ’ ikla ħafifa, li ma fihiex ħafna xaħam.
In adults, Crixivan can also be taken at a dose of 400 mg twice a day if each dose is taken with 100 mg ritonavir (another antiviral medicine) with or without food, in combination with other antiviral medicines.
Fl- adulti Crixivan jista ’ jiġi meħud ukoll f’ doża ta ’ 400mg darbtejn kuljum jekk kull doża tiġi meħuda flimkien ma ’ ritonavir (mediċina oħra antivirali) ma ’ l- ikel jew fuq stonku vojt, flimkien ma ’ mediċini antivirali oħrajn.
The use of Crixivan with ritonavir is based on limited evidence.
L- użu ta ’ Crixivan b’ ritonavir huwa bbażat fuq provi limitati.
The dose of Crixivan will need to be adjusted in patients taking some other medicines or who have problems with their liver.
Id- doża tal- Crixivan għandha tiġi aġġustata f’ pazjenti li jieħdu mediċini oħra jew li għandhom problemi fil- fwied tagħhom.
To avoid the risk of developing kidney stones, patients should drink plenty of liquids (at least 1.5 litres every day for adults).
Il- pazjenti għandhom jixorbu ħafna likwidi sabiex jevitaw ir- riskju li jiżviluppaw ġebel fil- kliewi (ta ’ l- inqas 1. 5 litri kuljum għall- adulti).
How does Crixivan work?
Kif jaħdem Crixivan?
The active substance in Crixivan, indinavir, is a protease inhibitor.
Is- sostanza attiva ta ’ Crixivan, indinavir, hija inibitur protiż.
It blocks an enzyme called protease, which is involved in the reproduction of HIV.
Dawn jimblokkaw enzima (protiż) li hija involuta fir- riproduzzjoni ta ’ l- HIV.
When the enzyme is blocked, the virus does not reproduce normally, slowing down the spread of infection.
Meta l- enzima tiġi imblokkata, il- virus ma jirriproduċix ruħu b’ mod normali, li jittardja l- firxa ta ’ l- infezzjoni.
Crixivan
Crixivan ma jikkurax l - infezzjoni ta ’ l- HIV jew ta ’ l- AIDS, iżda jista ’ jdewwem il- ħsara għas- sistema immunoloġika u l - iżvilupp ta ’ infezzjonijiet assoċjati ma ’ l- AIDS.
Ritonavir is another protease inhibitor that is used as a ‘ booster’.
Ritonavir huwa inibitur protiż ieħor li huwa wżat bħala ‘ booster ’.
It slows down the rate at which indinavir is broken down, increasing the levels of indinavir in the blood.
Dan inaqqas ir- rata li bih indinavir jitkisser, iżid il- livelli ta ’ indinavir fid- demm.
This allows a lower dose of indinavir to be used for the same antiviral effect.
Dan jippermetti sabiex tintuża doża anqas qawwija ta ’ indinavir għall- istess effetti antivirali.
How has Crixivan been studied?
Kif ġie studjat Crixivan?
The effectiveness of Crixivan taken without ritonavir has been studied in three studies involving 524 patients infected with HIV.
L- effikaċja ta ’ Crixivan meħud mingħajr ritonavir ġiet studjata fi tliet studji li jinvolvu 524 pazjenti infettati bl- HIV.
The first study compared the effects of Crixivan with those of zidovudine (another antiviral medicine) and the combination of both medicines.
L- ewwel studju qabbel l- effetti tal- Crixivan ma ’ dawk ta ’ żidovadin (mediċina antivirali oħra) u l- kombinazzjoni taż- żewġ mediċini.
The other two studies compared Crixivan, taken with zidovudine and either didanosine or lamivudine (other antiviral medicines), with Crixivan taken alone, and with the combination of zidovudine and either didanosine or lamivudine.
Iż- żewġ studji l- oħra qabblu Crixivan, meħud ma ’ żidovadin u jew id- didanosin jew il- lamivudin (mediċini antivirali oħrajn), u Crixivan meħud waħdu, u flimkien ma ’ żidovidin u jew didanosin jew lamivudin.
Crixivan, taken in combination with stavudine and lamivudine (other antiviral medicines), was also examined in 41 children aged between four and 15 years.
Crixivan meħdud flimkien ma ’ istavudin u lamivudin (mediċini antivirali oħrajn), ġie eżaminat ukoll f’ 41 tifel u tifla ta ’ etajiet bejn l - erba ’ u l- 15 – il sena.
The main measure of effectiveness was the viral load (the level of HIV in the patient ’ s blood) after 24 weeks of treatment.
Il- miżura prinċipali ta ’ effikaċja kienet it- tagħbija virali (il- livell ta ’ HIV fid - demm tal- pazjent) wara 24 ġimgħa ta ’ trattament.
The company also presented the results of four studies from the scientific literature that looked at the effects of taking Crixivan in combination with ritonavir.
Il- kumpanija ppreżentat ir- riżultati ta ’ erba ’ studji minn dokumentazzjoni speċifika li tiffoka fuq l - effetti ta ’ meta wieħed jieħu Crixivan flimkien ma ’ ritonavir.
One study involved 20 patients who had already been taking Crixivan without ritonavir, and three involved a total of 123 patients who had not taken treatment for HIV infection before.
Studju wieħed involva 20 pazjent li diġa ’ kienu qed jieħdu Crixivan mingħajr ritonavir, u tlieta involvew total ta ’ 123 pazjent li ma kienux ħadu trattament għall- infezzjoni ta ’ l- HIV qabel.
What benefit has Crixivan shown during the studies?
Liema benefiċċju wera Crixivan waqt l- istudji li ġew mwettqa?
Crixivan, taken in combination with other antiviral medicines but without ritonavir, was more effective than comparator medicines in reducing viral loads.
Crixivan meħud flimkien ma ’ mediċini antivirali oħrajn, kien aktar effikaċi minn mediċini li kien qed jitqabbel magħhom għat- tnaqqis tat- tagħbija virali.
In the first study, more patients taking Crixivan with zidovudine had a 99% reduction in viral load after 24 weeks, than those taking Crixivan alone.
Fl- ewwel studju, aktar pazjenti li kienu qed jieħdu l- Crixivan biż- żidovidin kellhom tnaqqis ta ’ 99% fit- tagħbija virali wara 24 ġimgħa minn dawk jieħdu l- Crixivan waħdu.
In the second study, 53% of the patients taking Crixivan with two other antiviral medicines had reductions in viral load of at least 99%, compared with around 20% of those taking Crixivan alone or taking zidovudine and didanosine.
Fit- tieni studju, 53% tal- pazjenti li kienu qed jieħdu l- Crixivan ma ’ żewġ mediċini antiviral oħrajn kellhom tnaqqis fit- tagħbija virali ta ’ mill- anqas 99%, imqabbel ma ’ madwar 20% minn dawk li kienu qed jieħdu Crixivan waħdu jew li jieħdu żidovudin u didanosin.
The third study had similar results:
It- tielet studju kellu riżultati simili:
90% of those taking three medicines including Crixivan had viral loads below 500 copies/ ml, compared with 43% of those taking Crixivan alone and 0% of those taking two antiviral medicines.
90% ta ’ dawk li kienu qed jieħdu l- mediċini inkluż u Crixivan kellhom tagħbijiet virali ta ’ anqas minn 500 kopja/ ml. imqabbla mat- 43% li kienu qed jieħdu l- Crixivan waħdu u 0% ta ’ dawk li kienu qed jieħdu ż- żewġ mediċini antivirali.
Around half of the children tested had viral loads below 50 copies/ ml after 24 weeks of taking Crixivan with two other antiviral medicines.
Madwar nofs it- tfal ittestjati kellhom tagħbijiet virali ta ’ anqas minn 50 kopji/ ml wara 24 ġimgħa li kienu qed jieħdu l- Crixivan ma ’ żewġ mediċini antivirali oħrajn.
The studies of Crixivan taken with ritonavir showed that the combination produced similar blood levels of indinavir to Crixivan taken without ritonavir.
L- istudji ta ’ Crixivan meħud ma ’ ritonavir juru li l- kombinazzjoni produċiet livelli ta ’ demm simili għal indinavir meta Crixivan ġie meħud mingħajr ritonavir.
The combination was effective for up to two years.
Il- kumbinazzjoni kienet effikaċi sa sentejn.
What is the risk associated with Crixivan?
X’ inhu r- riskju assoċjat ma ’ Crixivan?
The most common side effects when taking Crixivan (seen in more than 1 patient in 10) are headache, dizziness, nausea (feeling sick), vomiting, diarrhoea, dyspepsia (heartburn), rash, dry skin, asthenia (weakness), fatigue (tiredness), taste perversion (an unusual taste in the mouth), and abdominal (tummy) pain.
L- aktar effetti sekondarji komuni fit- teħid ta ’ Crixivan (kif muri f’ aktar minn pazjent minn kull għaxra) huma uġiegħ ta ’ ras, sturdament, dardir (wieħed iħossu ma jiflaħx), remettar, dijarrea, dispepsja (heartburn), raxx, ġilda xotta, ħedla (telqa) u l- għeja, tibdil fit- togħma (togħma mhux tas- soltu fil- ħalq), u uġiegħ addominali (żaqq).
Nephrolithiasis has been seen very commonly in children aged three years and older.
Nefrolitiasis instabu l- iktar fit- tfal ta ’ tliet snin jew aktar.
For a more complete list of all side effects reported with Crixivan, see the Package Leaflet.
Għal lista aktar sħiħa ta ’ l- effetti sekondarji rrapportati bi Crixivan, ara l- Fuljett ta ’ Tagħrif tal- Pakkett.
Crixivan should not be used in people who may be hypersensitive (allergic) to indinavir or any of the other ingredients.
Crixivan ma għandux jintuża f’ nies li jista ’ jkollhom sensittività eċċessiva (allerġiċi) għall- indinavir jew għal xi sostanzi oħra.
Crixivan should not be used in patients who are taking any of the following medicines: • medicines that are broken down in the same way as Crixivan and are harmful at high levels in the blood; • amiodarone (used to correct irregular heartbeat); • terfenadine, astemizole (commonly used to treat allergy symptoms – these medicines may be available without a prescription); • cisapride (used to treat certain stomach problems); • alprazolam, triazolam, midazolam taken by mouth (used to treat anxiety or difficulty sleeping); • pimozide (used to treat mental illness); • ergot derivatives (used to treat migraine headache); • simvastatin, lovastatin (used to lower cholesterol in the blood); • rifampicin (used to treat tuberculosis); • St John ’ s wort (a herbal preparation used to treat depression).
Ara l- Fuljett ta ’ Tagħrif għal aktar dettalji.
See the Package Leaflet for further details.
2/ 3 Restrizzjonijiet addizzjonali japplikaw meta Crixivan jiġu meħud ma ’ ritonavir.
Additional restrictions apply when Crixivan is taken with ritonavir.
Ara l- Fuljett ta ’ Tagħrif mogħti ma ’ ritonavir għal lista sħiħa.
As with other anti-HIV medicines, patients taking Crixivan may also be at risk of lipodystrophy (changes in the distribution of body fat), osteonecrosis (death of bone tissue) or immune reactivation syndrome (symptoms of infection caused by the recovering immune system).
Bħal fil- każ ta ’ mediċini ta ’ kontra l- HIV oħra, pazjenti li qed jieħdu Crixivan jistgħu jkunu f’ riskju ta ’ lipodistrofija (bidliet fit- tqassim tax- xaħam tal- ġisem), osteonekrosi (mewt tat- tessut ta ’ l- għadam) jew sindromu ta ’ riattivazzjoni immuni (sintomi ta ’ infezzjoni kkaġunati mis- sistema immuni li qed tirkupra).
Patients who have problems with their liver (including hepatitis B or C infection) may be at an elevated risk of liver damage when taking Crixivan.
Pazjenti li għandhom problemi bil- fwied tagħhom (li jinkludu infezzjoni ta ’ epatite B jew Ċ) jistgħu jkunu f’ riskju akbar ta ’ ħsara fil- fwied meta jieħdu Crixivan.
Why has Crixivan been approved?
Għaliex ġie approvat Crixivan?
The Committee for Medicinal Products for Human Use (CHMP) decided that Crixivan’ s benefits are greater than its risks in combination with antiretroviral nucleoside analogues for the treatment of HIV-1 infected adults, adolescents, and children four years of age and older.
Il- Kumitat għal Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) iddeċieda li l- benefiċċji tal - Crixivan huwa akbar mir- riskji f’ kumbinazzjoni ma ’ analogi nukleożojdi antiretrovirali għat - trattament antivirali kkombinat ta ’ l- HIV għal adulti, adoloxxenti u tfal taħt l- età ta ’ erba ’ snin jew aktar infettati b’ HIV.
The Committee recommended that Crixivan be given marketing authorisation.
Il- Kumitat għall- Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) li Crixivan jiġi mogħti awtorizzazzjoni għat- tqegħid fis- suq.
Crixivan was originally authorised under ‘ Exceptional Circumstances’, because, for scientific reasons, limited information was available at the time of approval.
Oriġinarjament Crixivan kien awtorizzat taħt ‘ Ċirkustanzi ta ’ Eċċezzjoni ’, minħabba li, għal raġunijiet xjentifiċi, kienet disponibbli informazzjoni limitata fil- ħin ta ’ l- approvazzjoni.
As the company had supplied the additional information requested, the ‘ Exceptional Circumstances ’ ended on 8 April 1998.
Billi l- kumpanija kienet ipprovdiet it- tagħrif addizzjonali mitlub, iċ - ‘ Ċirkustanzi ta ’ Eċċezzjoni ’ spiċċaw fit- 8 ta ’ April 1998.
Other information about Crixivan:
Informazzjoni oħra dwar Crixivan:
The European Commission granted a marketing authorisation valid throughout the European Union for Crixivan to Merck Sharp & Dohme Limited on 4 October 1996.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fis- suq valida madwar l- Unjoni Ewropea kollha, għal Crixivan lil Merck Sharp & Dohme Limited fl- 4 ta ’ Ottubru 1996.
The marketing authorisation was renewed on 4 October 2001 and on 4 October 2006.
L- awtorizzazzjoni għat- tqegħid fis- suq ġiet aġġornata fl- 4 ta ’ Ottubru 2001 u fl- 4 ta ’ Ottubru 2006.
The full EPAR for Crixivan can be found here.
L- EPAR sħiħ għal Crixivan jista ’ jiġi kkonsultat hawnhekk
This summary was last updated in 06-2008.
Dan is- sommarju kien aġġornat l- aħħar fi 06- 2008.
EU Number
Numru ta ’ l- UE
Capsule, hard Capsule, hard Capsule, hard Capsule, hard Capsule, hard Capsule, hard Capsule, hard
Kapsula, iebsa Kapsula, iebsa Kapsula, iebsa Kapsula, iebsa Kapsula, iebsa Kapsula, iebsa Kapsula, iebsa
Oral use Oral use Oral use Oral use Oral use Oral use Oral use
Użu mill- ħalq Użu mill- ħalq Użu mill- ħalq Użu mill- ħalq Użu mill- ħalq Użu mill- ħalq Użu mill- ħalq
bottle (HDPE) bottle (HDPE) bottle (HDPE) bottle (HDPE) bottle (HDPE) bottle (HDPE) bottle (HDPE)
flixkun (HDPE) flixkun (HDPE) flixkun (HDPE) flixkun (HDPE) flixkun (HDPE) flixkun (HDPE) flixkun (HDPE)
CRIXIVAN 100 mg hard capsules
CRIXIVAN 100 mg kapsuli ibsin
Each hard capsule contains indinavir sulphate corresponding to 100 mg of indinavir.
Kull kapsula iebsa fiha indinavir sulphate li jikkorrispondi għal 100 mg ta ’ indinavir.
Each 100 mg capsule contains 37.4 mg lactose.
Sustanza mhux attiva: kull 100 mg fiha 37. 4 mg lactose.
For a full list of excipients, see section 6.1.
Għall- lista sħiħa ta ’ sustanzi mhux attivi, ara Sezzjoni 6. 1
Hard capsule.
Kapsula iebsa.
The capsules are semi– translucent white and coded CRIXIVAN™ 100 mg in green.
Il- kapsuli huma bojod semi– trasluċidi u kkodifikati CRIXIVAN™ 100 mg bl- aħdar.
CRIXIVAN is indicated in combination with antiretroviral nucleoside analogues for the treatment of HIV– 1 infected adults, adolescents, and children 4 years of age and older.
CRIXIVAN huwa indikat flimkien ma ’ antiretroviral nucleoside analogues għat- trattament ta ’ adulti, adoloxxenti u tfal ta ’ 4 snin jew iktar infettati bl- HIV- 1.
In adolescents and children, the benefit of indinavir therapy versus the increased risk of nephrolithiasis should particularly be considered (see section 4.4).
(ara sezzjoni 4. 4).
CRIXIVAN should be administered by physicians who are experienced in the treatment of HIV infection.
CRIXIVAN għandu jingħata minn tobba li għandhom esperjenza fil- kura ta ’ l- infezzjoni bl- HIV.
On the basis of current pharmacodynamic data, indinavir must be used in combination with other antiretroviral agents.
Skond it- tagħrif farmakodinamiku li għandna s’ issa, indinavir għandu jintuża ma ’ aġenti antiretrovirali oħra.
When indinavir is administered as monotherapy resistant viruses rapidly emerge (see section 5.1).
(ara sezzjoni 5. 1).
Adults The recommended dosage of CRIXIVAN is 800 mg orally every 8 hours.
Adulti Id- doża rakkomandata ta ’ CRIXIVAN hija 800 mg mill- ħalq kull 8 sigħat.
Data from published studies suggest that CRIXIVAN 400 mg in combination with ritonavir 100 mg, both administered orally twice daily, may be an alternative dosing regimen.
Data mill- istudji ppubblikati tissuġġerixxi li CRIXIVAN 400 mg f’ kombinazzjoni ma ’ ritonavir 100 mg, it- tnejn li huma mogħtija mill- ħalq darbtejn kuljum, jista ’ jkun reġimen ta ’ dożaġġ alternattiv.
The suggestion is based on limited published data (see section 5.2).
Is - suġġeriment huwa bbażat fuq data ppubblikata limitata (ara sezzjoni 5. 2).
If co-administered with ritonavir, CRIXIVAN may be administered with or without food.
Jekk mogħti flimkien ma ’ ritonavir, CRIXIVAN jista ’ jingħata bi jew mingħajr ikel.
Children and adolescents (4 to 17 years of age) The recommended dosage of CRIXIVAN for patients 4 to 17 years of age is 500 mg/ m2 (dose adjusted from calculated body surface area [BSA] based on height and weight) orally every 8 hours (see table below).
Tfal u adoloxxenti (bejn l- 4 sa s- 17- il sena) Id- doża rakkomandata ta ’ CRIXIVAN għal pazjenti bejn l- 4 u s- 17- il sena hija 500 mg/ m2 (doża mbiddla skond l- erja tal- wiċċ tal- ġisem [BSA] ikkalkulata skond l- għoli u l- piż) oralment kull 8 sigħat (ara t- tabella hawn taħt).
This dose should not exceed the equivalent of the adult dose of 800 mg every 8 hours.
Din id- doża m’ għandhiex taqbeż l- ekwivalenti tad- doża adulta ta ’ 800 mg kull 8 sigħat.
CRIXIVAN has not been studied in children under the age of 4 years (see section 5.1 and 5.2).
CRIXIVAN ma ġiex studjat fi tfal taħt l- 4 snin (ara sezzjoni 5. 1 u 5. 2).
2 Paediatric dose (500 mg/ m2) to be administered every 8 hours
2 Id- doża għat- tfal (50 mg / m2) li għandha tingħata kull 8 sigħat
Body Surface Area (m2)
Erja tal- wiċċ tal- ġisem (m2) 0. 50 0. 75 1. 00 1. 25 1. 50
300 400 500 600 800
Doża ta ’ CRIXIVAN Kull 8 sigħat (mg) 300 400 500 600 800
General administration recommendations The hard capsules should be swallowed whole.
Rakkomandazzjonijiet ġenerali ta ’ kif jingħata Il- kapsuli ibsin jinbelgħu sħaħ.
Since CRIXIVAN must be taken at intervals of 8 hours, a schedule convenient for the patient should be developed.
Billi CRIXIVAN irid jingħata kull 8 sigħat, għandha tinħadem skeda li hija konvenjenti għall- pazjent.
For optimal absorption, CRIXIVAN should be administered without food but with water 1 hour before or 2 hours after a meal.
Biex CRIXIVAN jiġi assorbit bl- aħjar mod, għandu jingħata mingħajr ikel imma ma ’ l- ilma siegħa qabel jew sagħtejn wara l- ikel.
Alternatively, CRIXIVAN may be administered with a low– fat, light meal.
Minflok, CRIXIVAN jista ’ jingħata wkoll ma ’ ikla ħafifa bi ftit xaħam.
To ensure adequate hydration, it is recommended that adults drink at least 1.5 litres of liquids during the course of 24 hours.
Biex ikun hemm idrazzjoni xierqa, huma rakkomandat li l- adulti jixorbu mill- inqas 1. 5 litri ta ’ likwidi matul 24 siegħa.
It is also recommended that children who weigh less than 20 kg drink at least 75 ml/ kg/ day and that children who weigh 20 to 40 kg drink at least 50 ml/ kg/ day.
Huwa rakkomandat ukoll li t- tfal li jiżnu inqas minn 20 kg jixorbu mill- inqas 75 ml/ kg/ jum u li t- tfal li jiżnu bejn 20 u 40 kg jixorbu mill- inqas 50 ml/ kg/ jum.
Medical management in patients with one or more episodes of nephrolithiasis must include adequate hydration and may include temporary interruption of therapy (e. g., 1 to 3 days) during the acute episode of nephrolithiasis or discontinuation of therapy (see section 4.4).
Il- kura medika ta ’ pazjenti li kellhom episodju jew tnejn ta ’ nefrolitjasis trid tinkludi idrazzjoni xierqa u tista ’ tinkludi li t- terapija titwaqqaf għal ftit (ngħidu aħna bejn jum u 3 ijiem) waqt episodju akut ta ’ nefrolitjasis jew it- twaqqif tat- terapija (ara sezzjoni 4. 4).
Special dosing considerations in adults A dosage reduction of CRIXIVAN to 600 mg every 8 hours should be considered when administering itraconazole or ketoconazole concurrently (see section 4.5).
Konsiderazzjonijiet speċjali għall- adulti dwar id- doża Għandu jitqies tnaqqis fid- doża ta ’ CRIXIVAN għal 600 mg kull 8 sigħat meta jingħata ma itraconazole jew ketoconazole fl- istess ħin (ara sezzjoni 4. 5).
In patients with mild– to– moderate hepatic impairment due to cirrhosis, the dosage of CRIXIVAN should be reduced to 600 mg every 8 hours.
F’ pazjenti li għandhom indeboliment minn ħafif sa moderat fil- fwied minħabba ċirrożi, id- doża ta ’ CRIXIVAN għandha titnaqqas għal 600 mg kull 8 sigħat.
The recommendation is based on limited pharmacokinetic data (see section 5.2).
Din ir- rakkomandazzjoni hija bbażata fuq tagħrif farmakokinetiku limitat (ara sezzjoni 5. 2).
Patients with severe hepatic impairment have not been studied; therefore, no dosing recommendations can be made (see section 4.4).
Ma ġewx studjati pazjenti li għandhom ħsara qawwija fil- fwied; għalhekk, ma jistgħux isiru rakkomandazzjonijiet tad- doża (ara sezzjoni 4. 4).
Safety in patients with impaired renal function has not been studied; however, less than 20% of indinavir is excreted in the urine as unchanged drug or metabolites (see section 4.4).
Ma ġietx studjata s- sigurta` f’ pazjenti b’ indeboliment fil- fwied; madankollu inqas minn 20% ta ’ indinavir jitneħħa ma ’ l- urina bħala prodott mhux mibdul jew metaboliti (ara sezzjoni 4. 4).
Indinavir with or without ritonavir should not be administered concurrently with medicinal products with narrow therapeutic windows and which are substrates of CYP3A4.
Indinavir bi jew mingħajr ritonavir ma għandux jingħata fl- istess ħin ma ’ prodotti mediċinali bi twieqi terapewtiċi dojoq u li huma sottostrati ta ’ CYP3A4.
Inhibition of CYP3A4 by both CRIXIVAN and ritonavir could result in elevated plasma concentrations of these medicines, potentially causing serious or life-threatening reactions.
L- inibizzjoni ta ’ CYP3A4 kemm minn CRIXIVAN kif ukoll minn ritonavir tista ’ tirriżulta f’ konċentrazzjonijiet għoljin ta ’ plażma ta ’ dawn il- mediċini, u dan jista ’ jikkawża reazzjonijiet serji jew ta ’ theddida għall- ħajja.
CRIXIVAN with or without ritonavir should not be administered concurrently with amiodarone, terfenadine, cisapride, astemizole, alprazolam, triazolam, midazolam administered orally (for caution on parenterally administered midazolam, see section 4.5), pimozide, ergot derivatives, simvastatin or lovastatin (see section 4.4).
CRIXIVAN bi jew mingħajr ritonavir ma għandux jingħata fl- istess ħin ma ’ amiodarone, terfenadine, cisapride, astemizole, alprazolam, triazolam, midazolam mogħtija mill- ħalq (għal kawtela fuq midazolam mogħti b’ mod parenterali, ara sezzjoni 4. 5), pimozide, derivattivi ergot, simvastatin jew lovastatin (ara sezzjoni 4. 4).
Combination of rifampicin with CRIXIVAN with or without concomitant low-dose ritonavir is contraindicated (see section 4.5).
Il- kombinazzjoni ta ’ rifampicin ma ’ CRIXIVAN bi jew mingħajr doża baxxa ta ’ ritonavir li tingħata fl- istess ħin hi kontraindikata (ara sezzjoni 4. 5).
Concurrent use of indinavir with herbal preparations containing St John’ s wort (hypericum perforatum) is contraindicated (see section 4.5).
L- użu fl- istess ħin ta ’ indinavir ma ’ preparazzjonijiet erbali li fihom St John’ s wort (hypericum perforatum) huwa kontra- indikat (ara sezzjoni 4. 5).
3 In addition, indinavir with ritonavir should not be administered with alfuzosin, meperidine, piroxicam, propoxyphene, bepridil, encainide, flecanide, propafenone, quinidine, fusidic acid, clozapine, clorazepate, diazepam, estazolam and flurazepam.
3 Barra minn hekk, indinavir ma ’ ritonavir ma għandux jingħata ma ’ alfuzosin, meperidine, piroxicam, propoxyphene, bepridil, encainide, flecanide, propafenone, quinidine, fusidic acid, clozapine, clorazepate, diazepam, estazolam u flurazepam.
Ritonavir should not be given with indinavir to patients with decompensated liver disease as ritonavir is principally metabolized and eliminated by the liver (see section 4.4).
Ritonavir ma għandux jingħata b’ indinavir lil pazjenti b’ mard tal- fwied dekompensat minħabba li ritonavir huwa metabolizzat prinċipalment u eliminate mill- fwied (ara sezzjoni 4. 4).
When CRIXIVAN is used with ritonavir, consult the Summary of Product Characteristics of ritonavir for additional contraindications.
Meta CRIXIVAN jintuża ma ’ ritonavir, ikkonsulta s- Sommarju tal- Karatteristiċi tal- Prodott ta ’ ritonavir għal kontraindikazzjonijiet addizzjonali.
Nephrolithiasis and tubulointerstitial nephritis Nephrolithiasis has occurred with indinavir therapy in adult and paediatric patients.
Nefrolitjasis u nefrajtis tubulointerstizjali Kien hemm fejn seħħet in- nefrolitjasis bit- terapija ta ’ indinavir f’ pazjenti adulti u t- tfal.
The frequency of nephrolithiasis is higher in paediatric patients than in adult patients.
Il- frekwenza ta ’ nefrolitjasis hija ogħla f’ pazjenti tfal milli f’ pazjenti adulti.
In some cases, nephrolithiasis has been associated with renal insufficiency or acute renal failure; in the majority of these cases renal insufficiency and acute renal failure were reversible.
F’ xi każijiet, in- nefrolitjasis ġiet assoċjata ma’ insuffiċjenza tal- kliewi jew ma ’ insuffiċjenza akuta tal- kliewi; fil- maġġoranza ta ’ dawn il- każijiet il- ħsara fil- kliewi u mard akut tal- fwied huwa reversibbli.
If signs and symptoms of nephrolithiasis, including flank pain with or without haematuria (including microscopic haematuria) occur, temporary interruption of therapy (e. g. for 1– 3 days) during the acute episode of nephrolithiasis or discontinuation of therapy may be considered.
Jekk ikun hemm sinjali u sintomi tan- nefrolitjasis, inkluż uġigħ fil- ġenb bid- demm fl- urina jew mingħajru (inkluż traċċi mikroskopiċi ta ’ demm fl- urina), għandha tiġi kkonsidrata l- interruzzjoni temporanja tat- terapija (ngħidu aħna għal bejn jum u 3 ijiem) jew il- waqfien tat- terapija waqt episodju qawwi ta ’ nefrolitjasis.
Paediatric patients who experience flank pain should be evaluated for the possibility of nephrolithiasis.
Pazjenti tfal li jkollhom uġigħ fil- ġenb iridu jiġu eżaminati għall- possiblita` ta ’ nefrolitjasis.
Evaluation may consist of urinalysis, serum BUN and creatinine, and ultrasound of the bladder and kidneys.
Dan l- eżami jista ’ jikkonsisti f’ analiżi ta ’ l- urina, is- serum BUN u l- kreatitina, u ultrasawnd tal- bużżieqa ta ’ l- urina u tal - kliewi.
The long– term effects of nephrolithiasis in paediatric patients are unknown.
Mhux magħrufa l- effetti fit- tul tan- nefrolitjasis fuq pazjenti tfal.
Adequate hydration is recommended in all patients on indinavir (see section 4.2 and 4.8).
Hija rakkomandata l - idrazzjoni adegwata tal- pazjenti kollha li jkunu qed jieħdu indinavir (ara sezzjoni 4. 2 u 4. 8).
Cases of interstitial nephritis with medullary calcification and cortical atrophy have been observed in patients with asymptomatic severe leucocyturia (> 100 cells/ high power field).
F’ pazjenti b’ lewkosajturja qawwija asintomatika (> 100 ċelluli/ high power field) ġew osservati każijiet ta ’ nefrajtis interstizjali b’ kalċifikazzjoni tal- mudullun u atrofija tal- kortiċi.
In patients at increased risk such as children, urinary screening should be considered.
F’ pazjenti b’ riskju ikbar bħal tfal, għandu jitqies l- eżami ta ’ l- urina.
If persistent severe leucocyturia is found, further investigation might be warranted.
Jekk tinstab lewkosajturja qawwija, jista ’ jkun hemm bżonn ta ’ investigazzjonijiet oħra.
Medicinal product interactions Indinavir should be used cautiously with other medicinal products that are potent inducers of CYP3A4.
Interazzjonjiet ta ’ prodotti mediċinali Indinavir għandu jintuża b’ kawtela ma ’ prodotti mediċinali oħra li jinduċu b’ mod qawwi CYP3A4.
Co– administration may result in decreased plasma concentrations of indinavir and as a consequence an increased risk for suboptimal treatment and facilitation of development of resistance (see section 4.5).
Meta jingħataw flimkien jista ’ jkun hemm tnaqqis fil- konċentrazzjonijiet ta ’ indinavir fil- plażma u bħala konsegwenza jkun hemm riskju ikbar ta ’ kura mhux mill- aqwa li jista ’ jiffaċilita l- iżvilupp ta ’ reżistenzi (ara sezzjoni 4. 5).
If indinavir is given with ritonavir, the potential interaction may be increased.
Jekk indinavir jingħata ma ’ ritonavir, l- interazzjoni potenzjali tista ’ tikber.
The Interactions section of the SPC for ritonavir should also be consulted for information about potential interactions.
Ghandha tinqara wkoll it - taqsima dwar l- Interazzjonijiet fl- SPC ta ’ ritonavir għal informazzjoni dwar il- potenzjal ta ’ interazzjonijiet.
Concomitant use of indinavir with lovastatin or simvastatin is not recommended due to an increased risk of myopathy including rhabdomyolysis.
Mhux rakkomandat li indinavir jingħata ma ’ lovastatin u simvastatin billi dan iwassal għal żieda fir - riskju ta ’ mijopatija inkluż rabdomijolajsis.
Based on an interaction study with lopinavir/ ritonavir, combination of rosuvastatin and protease inhibitors is not recommended.
Abbażi ta ’ studju ta ’ interazzjoni b’ lopinavir/ ritonavir. kombinazzjoni ta ’ rosuvastatin u inibituri protease mhijiex rakkomandata.
Caution must also be exercised if indinavir is used concurrently with atorvastatin.
Trid issir ukoll kawtela meta indinavir jintuża ma ’ atorvastatin.
The interaction of indinavir or indinavir/ ritonavir with pravastatin or fluvastatin is not known (see section 4.5).
L- interazzjoni ta ’ indinavir jew indinavir/ ritonavir ma ’ pravastatin jew fluvastatin mhijiex magħrufa (ara sezzjoni 4. 5).
Co– administration of CRIXIVAN with sildenafil, tadalafil and vardenafil (PDE5 inhibitors) are expected to substantially increase the plasma concentrations of these compounds and may result in an increase in PDE5 inhibitor– associated adverse events, including hypotension, visual changes, and priapism (see section 4.5).
Meta CRIXIVAN u sildenafil, tadalafil u vardenafil (inibituri PDE5) jingħataw flimkien, dawn mistennija li jżidu sostanzjalment il- konċentrazzjonijiet ta ’ dawn il- komposti fil- plażma u jistgħu jirriżultaw f’ inibitur PDE5- episodji negattivi assoċjati, li jinkudu l- ipotensjoni, bidliet fil- viżta, u erezzjoni mtawla (ara sezzjoni 4. 5).
Acute haemolytic anaemia Acute haemolytic anaemia has been reported which in some cases was severe and progressed rapidly.
Anemija emolitika akuta Ġiet irrapuratata anemija emolitika akuta li f’ xi każijiet kienet severa u żviluppat għall- agħar b’ mod mgħaġġel.
Once a diagnosis is apparent, appropriate measures for the treatment of haemolytic anaemia should be instituted which may include discontinuation of indinavir.
Ladarba d- dijanjosi tkun ċara, għandhom jittieħdu l- miżuri xierqa għall- kura ta ’ l- anemija emolitika, u dan jista ’ jinkludi t- twaqqif ta ’ indinavir.
4 Hyperglycaemia New onset diabetes mellitus, hyperglycaemia or exacerbation of existing diabetes mellitus has been reported in patients receiving protease inhibitors (PIs).
4 Ipergliċemija F’ pazjenti li kienu qed jingħataw inibituri tal- protease (PIs) ġew irrappurati l- bidu tad- dijabete mellitus, l- ipergliċemija u t- tiħrix tad- dijabete mellitus eżistenti.
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 każijiet assoċjata ma ’ ketoaċidożi.
Many patients had confounding medical conditions, some of which required therapy with agents that have been associated with the development of diabetes mellitus or hyperglycaemia.
Ħafna pazjenti kellhom kondizzjonijiet mediċi li diffiċli tagħrafhom minn xulxin, li xi wħud minnhom kellhom bżonn terapija b’ aġenti li ġew assoċjati ma ’ l- iżvilupp tad- dijabete mellitus jew ipergliċemija.
Fat redistribution Combination antiretroviral therapy has been associated with the redistribution of body fat (lipodystrophy) in HIV patients.
(lipodistrofija) f’ pazjenti bl- HIV.
The long term consequences of these events are currently unknown.
Bħalissa mhux magħrufa l- effetti fit- tul ta ’ dan.
Knowledge about the mechanism is incomplete.
L- għarfien dwar dan il- mekkaniżmu mhux komplut.
A connection between visceral lipomatosis and PIs and lipoatrophy and nucleoside reverse transcriptase inhibitors (NRTIs) has been hypothesised.
Ġiet ipotizzata l- konessjoni bejn il- lipomatowsis vixxerali u l- PIs, u l - lipoatrofija u nucleoside reverse transcriptase inhibitors (NRTIs).
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 ogħla ta ’ lipodistrofija ġie assoċjat ma ’ fatturi individwali bħall- eta` ikbar, u effetti marbuta mal- mediċini bħal kura antiretrovirali li tkun damet iktar u assoċjati ma ’ disturbi metaboliċi.
Clinical examination should include evaluation for physical signs of fat redistribution.
L- eżami kliniku għandu jfittex ukoll għal sinjali fiżiċi ta ’ ridistribuzzjoni tax- xaħam.
Consideration should be given to the measurement of fasting serum lipids and blood glucose.
Għandu jitqies jekk għandhomx jitkejlu l- lipidi tas- serum u l- glukowż tad- demm waqt sawm.
Lipid disorders should be managed as clinically appropriate (see section 4.8).
Il- mard mal- lipidi għandu jiġi kkurat kif inhu klinikament xieraq (ara sezzjoni 4. 8).
Liver disease The safety and efficacy of indinavir has not been established in patients with significant underlying liver disorders.
Mard tal- fwied Ma ġewx stabbiliti s- sigurta` u l- effikaċja ta ’ indinavir f’ pazjenti bi problemi ’ sottostanti serji ta- fwied.
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 events.
Pazjenti b’ epatite B jew C kronika u kkurati b’ terapija mħallta antiretrovirali għandhom riskju ogħla ta ’ episodji negattivi qawwija u potenzjalment fatali fil- fwied.
In case of concomitant antiviral therapy for hepatitis B or C, please refer also to the relevant product information for these medicinal products.
Fil- każ ta ’ terapija antivirali għall - epatite B u C li tittieħed fl- istess ħin, jekk jogħġbok irreferi wkoll għall- informazzjoni relevanti dwar dawn il- prodotti mediċinali.
The safety and efficacy of indinavir/ ritonavir has not been established in patients with significant underlying liver disorders and should not be used in this patient population.
Is- sigurtà u l- effikaċja ta ’ indinavir/ ritovanir ma ġietx stabbilita f’ pazjenti b’ disturbi tal- fwied sottostanti sinifikanti u ma għandhomx jintużaw f’ din il- popolazzjoni tal- pazjenti.
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 kellhom minn qabel mard fil- fwied li jinkludi epatite attiva kronika għandhom frekwenza ogħla ta ’ anormalitajiet fil- funzjoni tal- fwied waqt it- terapija kombinata antiretrovirali u għandhom ikunu taħt osservazzjoni skond il- prattika normali.
If there is evidence of worsening liver disease in such patients, interruption or discontinuation of treatment must be considered.
Jekk hemm ħjiel li l- mard tal- fwied f’ pazjenti bħal dawn qed jeħżien, għandha titqies l- interruzzjoni jew il- waqfien tal- kura.
An increased incidence of nephrolithiasis has been observed in patients with underlying liver disorders when treated with indinavir.
Ġiet osservata inċidenza ikbar ta ’ nefrolitjasis f’ pazjenti li għandhom mard sustanti fil- fwied meta kkurati b’ indinavir.
Immune Reactivation Syndrome In HIV-infected patients with sever 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.
Sindromu tar- Riattivazzjoni tas- Sistema Immunitarja F’ pazjenti infettati bl- HIV b’ defiċjenza severa tas- sistema immunitarja meta bdiet it- terapija antiretrovirali kombinata (CART), tista ’ toħroġ reazzjoni infjammatorja għal patoġeni asintomatiċi jew opportunistiċi residwali li tista ’ tikkawża kondizzjonijiet kliniċi serji, jew aggravazzjoni tas- sintomi.
Typically, such reactions have been observed within the first few weeks or months of initiation of CART.
Tipikament, reazzjonijiet bħal dawn ġew osservati fl- ewwel ftit ġimgħat jew xhur wara li tibda l - CART.
Relevant examples are cytomegalovirus retinitis, generalised and/ or focal mycobacterial infections, and Pneumocystis carinii pneumonia.
Eżempji relevanti huma: retinite ċitomegalovirus, infezzjonijiet mikobatterjali ġeneralizzati u/ jew fokali, u pulmonite Pneumocystis carinii.
Any inflammatory symptoms should be evaluated and treatment instituted when necessary.
Kull sintomu infjammatorju għandu jiġi evalwat u meta hemm bżonn tinbeda l- kura.
Patients with coexisting conditions There have been reports of increased bleeding, including spontaneous skin haematomas and haemarthroses, in haemophiliac patients type A and B treated with PIs.
Pazjenti b’ kondizzjonijiet oħra fl- istess ħin Kien hemm rapporti ta ’ żieda fid- dmija, inkluż ematomi spontanji tal- ġilda u emartrożi, f’ pazjenti emofiliċi ta ’ tipi A u B kkurati bil- PIs.
In some patients additional factor VIII was given.
Xi pazjenti ngħataw iktar fattur VIII.