qanastek/EMEA-V3 huggingface dataset:
The incidence of cough was similar in placebo (0.6%) and Tekturna treated (0.9%) patients.
L- inċidenza tas- sogħla kienet simili f’ pazjenti ikkurati bi plaċebo (0. 6%) u b’ Tekturna (0. 9%).
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
5 F’ kull sezzjoni ta ’ frekwenza, l- effetti mhux mixtieqa huma mniżżla skond is- serjetà tagħhom, bl- aktar serji jitniżżlu l- ewwel.
Angioedema has occurred during treatment with Tekturna.
Anġjoedema seħħet waqt il- kura b’ Tekturna.
In controlled clinical trials, angioedema occurred rarely during treatment with Tekturna with rates comparable to treatment with placebo or hydrochlorothiazide.
Fi provi kliniċi kkontrollati, anġjoedema seħħet b’ mod rari waqt il- kura b’ Tekturna b’ rati li setgħu jitqabblu mal- kura bi plaċebo jew hydrochlorthiazide.
Laboratory findings In controlled clinical trials, clinically relevant changes in standard laboratory parameters were uncommonly associated with the administration of Tekturna.
Sejbiet tal- laboratorju Fi provi kliniċi kkontrollati, bidliet klinikament rilevanti f’ parametri standard tal- laboratorju kienu assoċjati b’ mod mhux komuni ma ’ l- għoti ta ’ Tekturna.
In clinical studies in hypertensive patients, Tekturna had no clinically important effects on total cholesterol, high density lipoprotein cholesterol (HDL-C), fasting triglycerides, fasting glucose or uric acid.
Fi studji kliniċi f’ pazjenti bi pressjoni għolja, Tekturna ma kellux effetti klinikament importanti fuq il- kolesterol totali, lipoproteina tal- kolesterol ta ’ densità għolja (HDL- C), trigliċeridi ta ’ waqt is- sawm, glucose ta ’ waqt is- sawm jew uric acid.
Increases in serum potassium were minor and infrequent in patients with essential hypertension treated with Tekturna alone (0.9% compared to 0.6% with placebo).
Żiediet tal- potassium fis- serum kienu minuri u mhux frekwenti f’ pazjenti bil - pressjoni għolja naturali kkurata b’ Tekturna waħdu (0. 9% imqabbla ma ’ 0. 6% bil- plaċebo).
However, in one study where Tekturna was used in combination with an ACEI in a diabetic population, increases in serum potassium were more frequent (5.5%).
Madankollu, fi studju wieħed fejn Tekturna intuża ma ’ ACEI f’ popolazzjoni ta ’ pazjenti dijabetiċi iż - żiediet tal- potassium fis- serum kienu aktar frekwenti (5. 5%).
The most likely manifestations of overdosage would be hypotension, related to the antihypertensive effect of aliskiren.
L- aktar ħaga li x’ aktarx tidher b’ doża eċċessiva ta ’ Tekturna tkun pressjoni baxxa, relatata ma ’ l- effett ta ’ aliskiren li jbaxxi l- pressjoni.
Elevated PRA has been independently associated with increased cardiovascular risk in hypertensive and normotensive patients.
6 indipendenti ma ’ żiediet fir- riskju kardjovaskulari f’ pazjenti bi pressjoni għolja u pazjenti bi pressjoni normali.
6 Hypertension In hypertensive patients, once-daily administration of Tekturna at doses of 150 mg and 300 mg provided dose-dependent reductions in both systolic and diastolic blood pressure that were maintained over the entire 24-hour dose interval (maintaining benefit in the early morning) with a mean peak to trough ratio for diastolic response of up to 98% for the 300 mg dose.
Pressjoni għolja F’ pazjenti bil- pressjoni għolja, l- għotja darba kuljum ta ’ Tekturna b’ dożi ta ’ 150 mg u 300 mg ikkawżaw tnaqqis dipendenti mid- doża fil- pressjoni tad- demm sistolika u dijastolika li nżammu fuq perijodu sħiħ ta ’ 24 siegħa ta ’ l- intervall bejn id- dożi (b’ hekk żammew il- benefiċċju ta ’ kmieni filgħodu) b’ medja fil- proporzjon bejn l- ogħla u l- anqas għar- rispons dijastoliku sa ’ 98% għad- doża ta ’ 300 mg.
Tekturna has been studied in 1,864 patients aged 65 years or older, and in 426 patients aged 75 years or older.
Tekturna kien studjat f’ 1, 864 pazjent ta ’ etajiet minn 65 sena ’ l fuq, u f’ 426 pazjent ta ’ etajiet minn 75 sena ’ l fuq.
Tekturna monotherapy studies have shown blood pressure lowering effects comparable to other classes of antihypertensive agents including ACEI and ARB.
Studji b’ monoterapija b’ Tekturna urew li l- effetti li jbaxxi l- pressjoni kienu jitqabblu ma ’ klassijiet oħra ta ’ aġenti li jbaxxu l- pressjoni inklużi ACEI u ARB.
Compared to a diuretic (hydrochlorothiazide - HCTZ), Tekturna 300 mg lowered systolic/ diastolic blood pressure by 17.0/ 12.3 mmHg, compared to 14.4/ 10.5 mmHg for HCTZ 25 mg after 12 weeks of treatment.
Meta mqabbel ma ’ dijuretiku (hydrochlorothiazide - HCTZ), Tekturna 300 mg naqqas il- pressjoni sistolika/ dijastolika tad- demm b’ 17. 0/ 12. 3 mmHg, imqabbel ma ’ 14. 2/ 10. 5 mmHg għal HCTZ 25 mg wara 12- il ġimgħa ta ’ kura.
In diabetic hypertensive patients, Tekturna monotherapy was safe and effective.
F’ pazjenti dijabetiċi bil- pressjoni għolja, monoterapija ta ’ Tekturna kienet sigura u effettiva.
Combination therapy studies are available for Tekturna added to the diuretic hydrochlorothiazide, the ACEI ramipril, the calcium channel blocker amlodipine, the angiotensin receptor antagonist valsartan, and the beta blocker atenolol.
Hemm studji b’ terapija ta ’ kombinazzjoni għal Tekturna miżjud mad- dijuretiku hydrochlorthiazide, l - ACEI ramipril, l- imblukkatur tal- kanali tal- calcium amlodipine, l- antagonist tar- riċettur ta ’ l - angiotensin valsartan, u l- imblukkatur beta atenolol.
Tekturna induced an additive blood-pressure-lowering effect when added to hydrochlorothiazide and to ramipril.
Tekturna ikkawża tnaqqis fil- pressjoni tad- demm akbar meta żdied ma ’ hydrochlorthiazide u ma ’ ramipril.
In patients who did not adequately respond to 5 mg of the calcium channel blocker amlodipine, the addition of Tekturna 150 mg had a blood-pressure-lowering effect similar to that obtained by increasing amlodipine dose to 10 mg, but had a lower incidence of oedema (aliskiren 150 mg/ amlodipine 5 mg 2.1% vs. amlodipine 10 mg 11.2%).
F’ pazjenti li ma kellhomx rispons xieraq għall- 5 mg ta ’ l- imblokkatur tal- kanali tal- calcium amlodipine, iż- żieda ta ’ Tekturna 150 mg kellu effett li jbaxxi l- pressjoni simili għal dak miksub meta d- doża ta ’ amlodopine tiżdied għal 10 mg iżda kien hemm anqas każijiet ta ’ edema (aliskiren 150 mg/ amlodipine 5 mg 2. 1% vs amlodipine 10 mg 11. 2%).
Tekturna in combination with the angiotensin receptor antagonist valsartan showed an additive antihypertensive effect in the study specifically designed to investigate the effect of the combination therapy.
Tekturna flimkien ma ’ l- antagonist tar - riċettur ta ’ angiotensin valsartan wera effett ta ’ tnaqqis fil- pressjoni akbar fl- istudju li kien imfassal apposta sabiex jiġi mistħarreġ l- effett tat- terapija kombinata.
In obese hypertensive patients who did not adequately respond to HCTZ 25 mg, add-on treatment with Tekturna 300 mg provided additional blood pressure reduction that was comparable to add-on treatment with irbesartan 300 mg or amlodipine 10 mg.
F’ pazjenti obeżi li għandhom il- pressjoni għolja li ma wrewx rispons xieraq għal HCTZ 25 mg, kura bl- inklużjoni ta ’ Tekturna 300 mg ipprovdiet tnaqqis addizzjonali fil- pressjoni tad- demm li seta ’ jitqabbel ma ’ kura bl- inklużjoni ta ’ irbesartan 300 mg jew amlodipine 10 mg.
In diabetic hypertensive patients, Tekturna provided additive blood pressure reductions when added to ramipril, while the combination of Tekturna and ramipril had a lower incidence of cough (1.8%) than ramipril (4.7%).
F’ pazjenti dijabetiċi li għandhom il- pressjoni għolja, Tekturna ipprovda tnaqqis addittiv tal- pressjoni tad- demm meta ngħata ma ’ ramipril, filwaqt li l- kombinazzjoni ta ’ Tekturna u ramipril kellha anqas każijiet ta ’ sogħla (1. 8%) minn ramipril (4. 7%).
Excessive hypotension was uncommonly (0.1%) seen in patients with uncomplicated hypertension treated with Tekturna alone.
Pressjoni baxxa żżejjed kienet mhux komuni (0. 1%) f’ pazjenti bi pressjoni għolja mingħajr komplikazzjoni li kienu kkurati b’ Tekturna waħdu.
In a 3-month study of 302 patients with mild stable heart failure, all of whom were receiving standard therapy for stable heart failure, addition of Tekturna 150 mg was well tolerated.
Fi studju ta ’ 3 xhur fuq 302 pazjenti b’ insuffiċjenza tal- qalb stabbli u mhux severa (Klassi funzjonali NYHA II u III), li kollha kemm huma kienu qed jirċievu terapija standard għall- insuffiċjenza tal- qalb iż- żieda ta ’ Rasliez 150 mg kienet tollerata sew.
However the clinical significance of this reduction is unknown.
Il- livelli ta ’ peptajd natrijuretiku tat- tip- B (BNP) kienu mnaqqsa b’ 25% fil- fergħa ta ’ Tekturna meta mqabbla mal- plaċebo għalkemm is- sinifikat kliniku għadu mhux magħruf.
In a 6-month study of 599 patients with hypertension, type 2 diabetes mellitus, and nephropathy, all of whom were receiving losartan 100 mg and optimised antihypertensive background therapy, addition of Tekturna 300 mg achieved a 20% reduction versus placebo in urinary albumin: creatinine ratio (UACR), i. e. from 58 mg/ mmol to 46 mg/ mmol.
Fi studju ta ’ 6 xhur ta ’ 599 pazjent bi pressjoni għolja, dijabete mellitus tat- tip 2, u nefropatija, li kollha kemm huma kienu qed jingħataw losartan 100 mg u terapija ta ’ sfond adattata għal kontra l - pressjoni għolja, iż- żieda ta ’ Tekturna 300 mg kisbet tnaqqis ta ’ 20% kontra plaċebo, i. e. minn 58 mg/ mmol għal 46 mg/ mmol, fil- proporzjon ta ’ l- albumina mal- krejatina fl- awrina (UACR).
The proportion of patients who had UACR reduced at least 50% from baseline to endpoint was 24.7% and 12.5% for Tekturna and placebo, respectively.
Il - proporzjon tal- pazjenti li kellhom tnaqqis fil- UACR b’ mill- anqas 50% mill- linja bażi sat- tragward finali kien ta ’ 24. 7% u 12. 5% għal Tekturna u l- plaċebo, rispettivament.
The clinical relevance of a reduction in UACR is not established in the absence of an effect on blood pressure.
Ir- rilevanza klinika tat - tnaqqis fl- UACR mhux stabbilit fl- assenza ta ’ effett fuq il- pressjoni tad- demm.
Tekturna did not affect the serum concentration of creatinine but was associated with an increased frequency (4.2% vs.
Tekturna ma effettwax
1.9% for placebo) of serum potassium concentration (≥ 6.0 mmol/ l), although this was not statistically significant.
7 il- konċentrazzjoni fis- serum tal- krejatinina iżda kien assoċjat ma ’ żieda fil- frekwenza (4. 2% vs 1. 9% għal plaċebo) tal- konċentrazzjoni tal- potassium fis- serum (≥ 6. 0 mmol/ l), għalkemm dan ma kienx statistikament sinifikanti.
7 Beneficial effects of Tekturna on mortality and cardiovascular morbidity and target organ damage are currently unknown.
L- effetti benefiċi ta ’ Tekturna fuq il- mortalità jew morbidità kardjovaskulari u l- ħsara fl- organu milqut bħalissa mhumhiex magħrufa.
Consequently, no adjustment of the initial dose of aliskiren is required in patients with mild to severe hepatic impairment.
Mhux meħtieġ bdil tad - doża tal- bidu ta ’ Tekturna f’ pazjenti b’ indeboliment renali ħafif għal sever, iżda għandha tingħata attenzjoni f’ pazjenti b’ indeboliment renali sever.
8 5.3 Preclinical safety data
8 Il- farmakokinetika ta ’ aliskiren ma nbidlitx b’ mod sinifikanti f’ pazjenti b’ mard tal- fwied ħafif għal sever.
Tekturna 300 mg film-coated tablets
Tekturna 300 mg pilloli miksijin b’ rita
Co-administration of aliskiren with either valsartan (↓ 28%), metformin (↓ 28%), amlodipine (↑ 29%) or cimetidine (↑ 19%) resulted in between 20% and 30% change in Cmax or AUC of Tekturna.
Meta ngħata ma ’ atorvastatin, l -
When administered with atorvastatin, steady-state Tekturna AUC and Cmax increased by 50%.
12 AUC u Cmax fi stat fiss ta ’ Tekturna żdiedu b’ 50%.
Digoxin bioavailability may be slightly decreased by Tekturna.
Il- biodisponibilità ta ’ digoxin tista ’ titnaqqas xi ftit b’ Tekturna.
12 Preliminary data suggest that irbesartan may decrease Tekturna AUC and Cmax.
Tagħrif preliminari jindika li irbesartan jista ’ jnaqqas xi ftit l- AUC u s- Cmax ta ’ Tekturna.
15 Hypertension In hypertensive patients, once-daily administration of Tekturna at doses of 150 mg and 300 mg provided dose-dependent reductions in both systolic and diastolic blood pressure that were maintained over the entire 24-hour dose interval (maintaining benefit in the early morning) with a mean peak to trough ratio for diastolic response of up to 98% for the 300 mg dose.
Pressjoni għolja F’ pazjenti bil- pressjoni għolja, l- għotja darba kuljum ta ’ Tekturna b’ dożi ta ’ 150 mg u 300 mg ikkawżaw tnaqqis dipendenti mid- doża fil- pressjoni tad- demm sistolika u dijastolika li nżammu fuq perijodu sħiħ ta ’ 24 siegħa ta ’ l- intervall bejn id- dożi (b’ hekk żammew il- benefiċċju ta ’ kmieni filgħodu) b’ medja fil- proporzjon bejn l- oghla u l- anqas għar- rispons dijastoliku sa ’ 98% għad- doża ta ’ 300 mg.
1.9% for placebo) of serum potassium concentration (≥ 6.0 mmol/ l), although this was not statistically significant.
16 il- konċentrazzjoni fis- serum tal- krejatinina iżda kien assoċjat ma ’ żieda fil- frekwenza (4. 2% vs 1. 9% għal plaċebo) tal- konċentrazzjoni tal- potassium fis- serum (≥ 6. 0 mmol/ l), għalkemm dan ma kienx statistikament sinifikanti.
16 Beneficial effects of Tekturna on mortality and cardiovascular morbidity and target organ damage are currently unknown.
L- effetti benefiċi ta ’ Tekturna fuq il- mortalità jew morbidità kardjovaskulari u l- ħsara fl- organu milqut bħalissa mhumhiex magħrufa.
Tekturna 150 mg film-coated tablets Aliskiren
Tekturna 150 mg pilloli miksijin b’ rita Aliskiren
Tekturna 300 mg film-coated tablets Aliskiren
Tekturna 300 mg pilloli miksijin b’ rita Aliskiren
What Tekturna is and what it is used for 2.
X’ inhu Tekturna u għalxiex jintuża 2.
Before you take Tekturna 3.
Qabel ma tieħu Tekturna 3.
How to take Tekturna 4.
Kif għandek tieħu Tekturna 4.
How to store Tekturna 6.
Kif taħżen Tekturna 6.
WHAT TEKTURNA IS AND WHAT IT IS USED FOR
X’ INHU TEKTURNA U GĦALXIEX JINTUŻA
Tekturna belongs to a new class of medicines called renin inhibitors.
Rasliez jagħmel parti minn klassi ġdida ta ’ mediċini li jissejjħu inibituri ta ’ renin.
Tekturna helps to lower high blood pressure.
Tekturna jgħin biex ibaxxi l- pressjoni tad- demm għolja.
BEFORE YOU TAKE TEKTURNA
QABEL MA TIEĦU TEKTURNA
Do not take Tekturna
Tieħux Tekturna
If
- jekk inti allerġiku/ a (tbati minn sensittività eċċessiva) għal aliskiren jew sustanzi oħra ta ’
you think you may be allergic, ask your doctor for advice.
Jekk taħseb li tista ’ tkun allerġiku, staqsi lit- tabib tiegħek għal parir.
Take special care with Tekturna
Oqgħod attent ħafna b’ Tekturna
If any of these apply to you, tell your doctor before you take Tekturna.
Jekk xi wieħed minn dawn jgħodd għalik, għid lit- tabib tiegħek qabel tieħu Tekturna.
The use of Tekturna in children and adolescents is not recommended.
L- użu ta ’ Tekturna fi tfal u adolexxenti mhux rakkomandat.
Taking Tekturna with food and drink You should take Tekturna with a light meal once a day, preferably at the same time each day.
Meta tieħu Tekturna ma ’ l- ikel u max- xorb Għandek tieħu Tekturna ma ’ ikla ħafifa darba kuljum, l- aħjar fl- istess ħin kuljum.
You should not take Tekturna together with grapefruit juice.
M’ għandekx tieħu Tekturna mal- meraq tal- grejpfrut.
Pregnancy and breast-feeding Do not take Tekturna if you are pregnant.
Tqala u treddigħ Tieħux Tekturna jekk ħriġt tqila.
Do not breast-feed if you are taking Tekturna.
Treddax jekk qed tieħu Tekturna.
Before you drive a vehicle, use machinery, or carry out other activities that require concentration, you should make sure you know how you react to the effects of Tekturna.
Qabel issuq karozza, tħaddem makkinarju, jew tagħmel attivitajiet oħra li jeħtieġu konċentrazzjoni, għandhekk taċċerta ruħek li tkun taf x’ tip ta ’ reazjoni jkollok għall- effetti ta ’ Tekturna.
HOW TO TAKE TEKTURNA
KIF GĦANDEK TIEĦU TEKTURNA
Always take Tekturna exactly as your doctor has told you.
Dejjem għandek tieħu Tekturna skond il- parir eżatt tat- tabib.
Your doctor may prescribe Tekturna together with other medicines used to treat high blood pressure.
It- tabib tiegħek jista ’ jordnalek Tekturna ma ’ mediċini oħra li jintużaw biex jikkuraw il- pressjoni tad- demm għolja.
You should take Tekturna with a light meal once a day, preferably at the same time each day.
Għandek tieħu Tekturna ma ’ ikla ħafifa darba kuljum, l- aħjar fl- istess ħin kuljum.
You should not take Tekturna together with grapefruit juice.
M’ ghandekx tieħu Tekturna mal- meraq tal- grejpfrut.
If you take more Tekturna than you should If you have accidentally taken too many Tekturna tablets, consult a doctor immediately.
Jekk tieħu Tekturna aktar milli suppost Jekk bi żball ħadt wisq pilloli Tekturna, ikkonsulta mat- tabib tiegħek minnufih.
If you forget to take Tekturna If you forget to take a dose of Tekturna, take it as soon as you remember and then take the next dose at
Jekk tinsa tieħu Tekturna Jekk tinsa tieħu doża ta ’ Tekturna, ħudha hekk kif tiftakar u imbagħad ħu d- doża li jmissek fil- ħin tas - soltu.
Like all medicines, Tekturna can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, Tekturna jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
HOW TO STORE TEKTURNA
KIF TAĦŻEN TEKTURNA
Do not use Tekturna after the expiry date which is stated on the carton and blister.
Tużax Tekturna wara d- data ta ’ skadenza li tidher fuq il- kartuna u l- folja.
What Tekturna contains
X’ fih Tekturna
What Tekturna looks like and contents of the pack Tekturna 150 mg film coated tablets are light-pink, biconvex round tablets, imprinted “ IL ” on one side and “ NVR” on the other side.
Id- Dehra ta ’ Tekturna u l- kontenuti tal- pakkett Tekturna 150 mg pilloli miksijin b’ rita huma pilloli roża ċar, konvessi miż- żewġ naħat, tondi, ittimbrati ‘ IL ’ fuq naħa u ‘ NVR ’ fuq in- naħa l- oħra.
Tekturna is available in packs containing 7, 14, 28, 30, 50, 56, 84, 90, 98 or 280 tablets.
Tekturna jiġi f’ pakketti li jkun fihom 7, 14, 28, 30, 50, 56, 84, 90, 98 jew 280 pillola.
45 its usual time.
45 Jekk tinsa tieħu Tekturna Jekk tinsa tieħu doża ta ’ Tekturna, ħudha hekk kif tiftakar u imbagħad ħu d- doża li jmissek fil- ħin tas - soltu.
What Tekturna looks like and contents of the pack Tekturna 300 mg film coated tablets are light-red, biconvex, ovaloid tablets, imprinted “ IU” on one side and “ NVR” on the other side.
Id- Dehra ta ’ Tekturna u l- kontenuti tal- pakkett Tekturna 300 mg pilloli miksijin b’ rita huma pilloli aħmar ċar, konvessi miż- żewġ naħat, f’ għamla ovali, ittimbrati ‘ IU ’ fuq naħa u ‘ NVR ’ fuq in- naħa l- oħra.
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.
Huwa jispjega kif il- Kumitat għal Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) ivvaluta l- istudji mwettqin, biex jasal għar- rakkomandazzjonijiet tiegħu dwar kif tintuża l- mediċina.
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- kondizzjoni medika tiegħek jew it- trattament tiegħek, aqra l- Fuljett ta ’ Tagħrif (ara parti mill- EPAR) jew ikkuntattja lit- tabib jew lill- ispiżjar tiegħek.
What is Telzir?
X' inhu Telzir?
Telzir is a medicine that contains the active substance fosamprenavir.
Telzir hu mediċina li fiha s- sustanza attiva fosamprenavir.
It is available as pink, capsule- shaped tablets (700 mg) and as an oral suspension (50 mg/ ml).
Tiġi bħala pilloli b' forma ta 'kapsula roża (700 mg) u bħala sospensjoni orali (50 mg/ ml).
What is Telzir used for?
Għalxiex jintuża Telzir?
Telzir is an antiviral medicine.
Telzir hu mediċina antivirali.
It is used in combination with ritonavir (another antiviral medicine) and other antiviral medicines to treat adults and children aged six years or above, who are 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 u tfal li jkollhom età ta ’ sitt snin jew iktar, li jkunu infettati bil - vajrus tal- immunodefiċenzja umana tip 1 (HIV- 1), vajrus li jikkawża s- sindromu mill - immunodefiċenzja akkwiżita (AIDS).
In patients who have already taken medicines belonging to the same class as Telzir (protease inhibitors), doctors should prescribe Telzir only after they have looked at the antiviral medicines the patient has taken before and the likelihood that the virus will respond to the medicine.
Għal dawk il- pazjenti li jkunu diġà ħadu mediċini fl- istess klassi ta 'Telzir (inibituri proteażi), it- tobba għandhom biss jippreskrivu Telzir wara li jkunu analizzaw x' mediċini jkun ħa l- pazjent qabel u l- probabilità li l- vajrus jirrispondi għall- mediċina.
How is Telzir used?
Kif jintuża Telzir?
Treatment with Telzir should be started by a doctor who has experience in the management of HIV infection.
It- trattament b' Telzir għandu jinbeda minn tabib li jkollu esperjenza fil- ġestjoni tal- infezzjoni tal- HIV.
The recommended dose of Telzir for adults and children weighing more than 39 kg is 700 mg twice a day.
Id- doża rrakkomandata ta 'Telzir għall- adulti u t- tfal li jkunu jiżnu iktar minn 39kg hija ta' 700 mg darbtejn kuljum.
In children aged six years and above who weigh between 25 and 39 kg, the dose depends on body weight.
Fi tfal li jkollhom sitt snin jew iktar u li jiżnu bejn 25 u 39 kg,, id- doża tiddependi minn kemm ikun jiżen il- ġisem.
There is no recommended dose for children below 25 kg.
M’ hemm l- ebda doża li hija rakkomandata għal tfal li jkunu jiżnu inqas minn 25kg.
Telzir tablets can be taken with or without food.
Il- pilloli Telzir jistgħu jittieħdu ma 'l- ikel jew mhux ma' l- ikel.
The oral suspension should be taken without food on an empty stomach in adults, but in children it should be taken with food in order to hide the taste and help them stick to treatment.
Is- sospensjoni orali għandha tittieħed mill- adulti mingħajr ikel fuq stonku vojt, iżda fit- tfal din għandha tittieħed ma ’ l- ikel sabiex tinħeba t - togħma u biex tgħinhom iżżommu t- trattament.
In adults, each dose of Telzir must be given with 100 mg ritonavir, twice a day.
Fl- adulti, kull doża ta ’ Telzir għandha tingħata ma '100 mg ritonavir, darbtejn kuljum.
In children, the ritonavir dose depends on body weight.
Fit- tfal, id- doża ta ’ ritonavir tiddependi mill- piż tal- ġisem.
Adults with liver problems should take a reduced dose and be closely monitored for safety and the response to treatment.
Fl- adulti bi problemi fil- fwied għandhom jieħdu doża inqas qawwija u jkunu taħt superviżjoni stretta għas- sigurtà u r- rispons għat- trattament.
Telzir has not been studied in patients under 18 years of age with liver problems.
Telzir ma ġiex studjat f’ pazjenti taħt it- 18- il sena bi problemi fil- fwied.
How does Telzir work?
Kif jaħdem Telzir?
The active substance in Telzir, fosamprenavir, is a ‘ prodrug ’ of the protease inhibitor amprenavir, which means that it is converted into amprenavir in the body.
Is- sustanza attiva f' Telzir, fosamprenavir, hi 'promediċina' tal- inibitur proteażi amprenavir li jfisser li din tinbidel f’ amprenavir fil- ġisem.
Amprenavir has been approved in the European Union (EU) since October 2000 as Agenerase.
Amprenavir ġie approvat għat- tqegħid fis- suq fl- Unjoni Ewropea (UE) minn Ottubru 2000 bħala Agenerase.
Amprenavir blocks an enzyme called protease, which is involved in the reproduction of HIV.
Amprenavir jimblokka enzima msejħa proteażi li għandha sehem fir- riproduzzjoni tal- HIV.
When the enzyme is blocked, the virus does not reproduce normally, slowing down the spread of infection.
Meta l- enzima tiġi mblukkata, il- vajrus ma jirriproduċix ruħu bħas - soltu, u dan inaqqas il- firxa tal- infezzjoni.
Ritonavir is another protease inhibitor that is used as a ‘ booster’.
(44- 20) 74 18 84 00 Fax (44- 20) 74 18 84 16 E- mail: mail@ emea. europa. eu http: // www. emea. europa. eu European Medicines Agency 2009 Reproduction is authorised for non commercial purposes only provided the EMEA is acknowledged Ritonavir hu inibitur proteażi li jintuża bħala ‘ booster ’.
It slows down the rate at which amprenavir is broken down, increasing the levels of amprenavir in the blood.
Inaqqas ir- rata li biha jitkisser amprenavir, u dan iżid il- livell ta 'amprenavir fid- demm.
This allows a lower dose of Telzir to be used for the same antiviral effect.
Dan jippermetti li tintuża doża iżgħar ta 'Telzir għall- istess effett antivirali.
Telzir, taken in combination with other antiviral medicines, reduces the amount of HIV in the blood and keeps it at a low level.
Telzir, meħud flimkien ma 'mediċini antivirali oħra, inaqqas l- ammont ta' HIV fid - demm u jżommu f' livell baxx.
Telzir does not cure HIV infection or AIDS, but it may delay the damage to the immune system and the development of infections and diseases associated with AIDS.
Telzir ma jfejjaqx infezzjoni tal- HIV jew l- AIDS, iżda jista 'jtawwal iż - żmien qabel ma ssir ħsara lis- sistema immunitarja u l- iżvilupp ta' infezzjonijiet u mardiet marbuta ma 'l- AIDS.
How has Telzir been studied?
Kif ġie studjat Telzir?
Telzir has been studied in three main studies involving 1,862 adults infected with HIV.
Telzir ġie studjat fi tliet studji ewlenin, li fihom ħadu sehem 1, 862 adult infettati bl- HIV.
The first compared ritonavir-boosted Telzir with nelfinavir (another protease inhibitor) in treatment-naïve adults (who had previously taken treatment for HIV infection for no longer than four weeks).
L- ewwel wieħed qabbel Telzir imsaħħaħ mir- ritonavir, ma 'nelfinavir (inibitur proteażi ieħor) fit- trattament ta' adulti naïve mit- trattament (li qabel kienu ħadu t- trattament għall- HIV għal mhux aktar minn erba ’ ġimgħat).
The other two studies compared Telzir with lopinavir (another protease inhibitor), both of which were boosted with ritonavir.
Iż- żewġ studji l- oħra qabblu Telzir ma 'lopinavir (inibitur proteażi ieħor), it- tnejn li huma kienu msaħħin mir- ritonavir.
In one of these studies, the patients were treatment-naïve, but in the other study, they had taken HIV treatment including protease inhibitors before.
F' wieħed minn dawn l- istudji, il- pazjenti ma kinux ħadu trattament għall - HIV, iżda fl- istudju l- ieħor kienu ħadu trattament qabel għall- HIV inkluż, inibituri proteażi.
In all three studies, the patients also took two reverse transcriptase inhibitors (another type of antiviral medicine).
Fit- tliet studji, il- pazjenti ħadu wkoll żewġ inibituri transkrittażi inversi (tip ieħor ta 'mediċina antivirali).
The main measure of effectiveness was the level of HIV in the blood (viral load) in the first 48 weeks of treatment.
Il - kejl ewlieni tal- effikaċja kien il- livell ta 'HIV fid- demm (tagħbija virali) fl- ewwel 48 ġimgħa ta' trattament.
The effectiveness of Telzir, in combination with other antiviral medicines, has also been assessed in one main study including 57 HIV-infected children aged between two and 18 years.
L- effikaċja ta ’ Telzir, flimkien ma ’ mediċini antivirali oħra, ġie wkoll studjat fi studju ewlieni ieħor li kien jinkludi wkoll 57 tifel u tifla li kienu infettati bl- HIV u li kellhom bejn sentejn u 18- il sena.
What benefit has Telzir shown during the studies?
X' benefiċċji wera Telzir matul l- istudji mwettqa?
In the studies of treatment-naïve adults, ritonavir-boosted Telzir was as effective as the comparator medicines, but it was less effective in treatment-experienced adults.
Fl- istudji ta 'adulti naïve mit- trattament, Telzir imsaħħaħ mir- ritonavir kien effikaċi daqs il- mediċini li tqabbel magħha, iżda kien inqas effikaċi f' adulti li kienu diġà ħadu trattament qabel.
After 48 weeks, 69% of the treatment-naïve adults taking ritonavir-boosted Telzir (221 out of 322) and 68% of those taking nelfinavir (221 out of 322) had viral loads below 400 copies/ ml.
Wara 48 ġimgħa, 69% tal- pazjenti naïve li kienu qed jieħdu Telzir imsaħħaħ bir- ritonavir (221minn 322) u 68% minn dawk li kienu qed jieħdu nelfinavir (221 minn 322) kellhom tagħbijiet virali ta 'inqas minn 400 kopja/ ml.
Similar results were seen in the study comparing Telzir with lopinavir, with around three-quarters of both groups of patients having viral loads below 400 copies/ ml.
Kien hemm riżultati simili fl- istudju li qabbel Telzir ma 'lopinavir, b' madwar tliet kwarti miż- żewġ gruppi ta' pazjenti li kellhom tagħbija virali ta ’ inqas minn 400 kopja/ ml.
In the study of treatment-experienced patients, the patients taking lopinavir had larger reductions in viral loads over the first 48 weeks.
Fl- istudju ta 'pazjenti li kienu ngħataw trattament, il- pazjenti li ħadu lopinavir kellhom tnaqqis ikbar fil- tagħbijiet virali matul l- ewwel 48 ġimgħa.
A similar benefit has also been seen in children receiving Telzir.
Kien hemm ukoll benefiċċju simili fit- tfal li ingħatalhom Telzir.
However, there were too few children aged below six years to support the use of Telzir in this age group.
Madanakollu, kien hemm ftit wisq tfal li kellhom inqas minn sitt snin, sabied ikun rakkomandat l- użu ta ’ Telzir f’ dan il- grupp ta ’ din l - età.
What is the risk associated with Telzir?
X' inhu r- riskju assoċjat ma 'Telzir?
The most common side effects in adults taking Telzir (seen in more than 1 patient in 10) are diarrhoea and increases in the levels of triglycerides (a type of fat) in the blood.
L- iktar effetti sekondarji komuni f’ adulti li jieħdu Telzir (li dehru f' pazjent 1 minn kull 10) huma dijarrea u żieda fil- livelli tat- trigliċeridi (tip ta 'xaħam) fid- demm.
Similar side effects are seen in children.
Effetti sekondarji simili ġew innutati wkoll fit- tfal.
For the full list of all side effects reported with Telzir, see the Package Leaflet.
Għal- lista sħiħa tal- effetti sekondarji rrapportati b' Telzir, ara l- Fuljett ta 'Tagħrif.
Telzir should not be used in people who may be hypersensitive (allergic) to fosamprenavir, amprenavir, any of the other ingredients, or ritonavir.
Telzir m' għandux jintuża minn persuni li jistgħu jkunu ipersensittivi (allerġiċi) għal fosamprenavir, amprenavir jew għal xi sustanza oħra ta 'Telzir jew ritonavir.
Telzir must not be used in patients who are taking rifampicin (used to treat tuberculosis), St John’ s wort (a herbal preparation used to treat depression) or medicines that are broken down in the same way as Telzir or ritonavir and are harmful at high levels in the blood.
Telzir m' għandux jintuża minn pazjenti li jkunu qed jieħdu rifampicin (użat fit- trattament tat- tuberkulożi), St John’ s wort (preparazzjoni tal - ħxejjex użata fit- trattament tad- depressjoni) jew mediċini li jitkissru bl- istess mod ta 'Telzir jew ritonavir u li jagħmlu l- ħsara meta l- livelli tagħhom fid- demm ikunu għoljin.
As Telzir is converted into amprenavir in the body, it must not be given at the same time as other medicines containing amprenavir.
Billi Telzir jinbidel f' amprenavir fil- ġisem, m' għandux jingħata fl- istess ħin ma 'mediċini oħra li jkun fihom amprenavir.
Caution is also needed by patients taking Telzir at the same time as other medicines.
Meta Telzir jingħata lil pazjenti li jkunu qegħdin jieħdu mediċini oħra, dan għandu jsir b' kawtela kbira.
As with other anti-HIV medicines, patients taking Telzir may 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 mediċini oħra ta 'kontra l- HIV, il- pazjenti li jkunu qed jieħdu Telzir jista' jkollhom riskju ta 'lipodistrofija (tibdiliet fid- distribuzzjoni tax- xaħam fid- demm), osteonekrożi (mewt tat- tessut tal - għadam) jew sindromu tar- riattivazzjoni tas- sistema immunitarja (sintomi ta' infezzjoni kkawżati minn sistema immunitarja li tkun 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 Telzir.
Il- pazjenti li jkollhom problemi bil- fwied (inkluż infezzjoni tal- epatite B jew Ċ) jista 'jkollhom riskju ogħla li ssirilhom ħsara fil- fwied meta jieħdu Telzir.
Why has Telzir been approved?
Għaliex ġie approvat Telzir?
The Committee for Medicinal Products for Human Use (CHMP) concluded that Telzir, which contains a prodrug of amprenavir, provides an advantage for patients, as the number of tablets they need to take is reduced when compared to the number of Agenerase capsules that they would need to take for the same dose of amprenavir.
Il- Kumitat għall- Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) ikkonkluda li Telzir, li fih il - promediċina amprenavir, jagħti vantaġġ lill- pazjenti, għax in- numru ta 'pilloli li jridu jieħdu hu inqas meta mqabbel man- numru ta' kapsuli ta 'Agenerase li kien ikollhom jieħdu għall- istess doża ta' amprenavir.
The Committee decided that Telzir’ s benefits are greater than its risks for the treatment of HIV-1 infected adults and children of six years and above in combination with other antiretroviral medicinal products.
ta 'adulti infettati bl- HIV- 1 u għat- tfal li jkollhom sitt snin jew iktar meta meħud flimkien ma' prodotti mediċinali antiretrovirali oħra.
The Committee noted that, in adults with moderate levels of exposure to antiviral medicines for the treatment of HIV infection, ritonavir-boosted Telzir has not 2/ 3 been shown to be as effective as ritonavir-boosted lopinavir.
Il- Kumitat innota li, f' pazjenti adulti li jkunu ġew esposti moderatament għal mediċini antivirali għat- trattament tal- infezzjoni tal- HIV, Telzir imsaħħaħ bir - ritonavir ma dehritx effikaċi daqs lopinavir imsaħħaħ bir- ritonavir.
In heavily pretreated patients, the use of ritonavir-boosted Telzir has not been studied sufficiently.
F' pazjenti li kienu ħadu trattament qawwi qabel, l- użu ta 'Telzir imsaħħaħ bir- ritonavir ma ġiex studjat biżżejjed.
In addition, no comparative studies have been carried out in children.
Barra minn hekk, ma sar l- ebda studju kumparattiv fuq it- tfal.
The Committee recommended that Telzir be given marketing authorisation.
Il- Kumitat irrakkomanda li Telzir jingħata awtorizzazzjoni għat- tqegħid fis- suq.
Other information about Telzir:
Tagħrif ieħor dwar Telzir:
The European Commission granted a marketing authorisation valid throughout the EU for Telzir to Glaxo Group Ltd on 12 July 2004.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fis- suq għal Telzir valida fl- Unjoni Ewropea kollha lil Glaxo Group Limited fit- 12 ta 'Lulju 2004.
The full EPAR for Telzir can be found here.
L- EPAR sħiħ għal Telzir jista 'jiġi kkonsultat hawn.
Telzir 700 mg film-coated tablets.
Telzir 700 mg pilloli miksijin b’ rita.
Each film-coated tablet contains 700 mg of fosamprenavir as fosamprenavir calcium (equivalent to approximately 600 mg of amprenavir).
Kull pillola miksija b’ rita fiha 700 milligramma ta ’ fosamprenavir bħala fosamprenavir calcium (ekwivalenti bejn wieħed u ieħor għal 600 mg ta ’ amprenavir)
Film-coated tablets.
Pilloli miksijin b’ rita
Pink film coated, capsule shaped, biconvex tablets, marked with GXLL7 on one side.
Pilloli roża miksijin b’ rita, għamla ta ’ kapsuli, imbuzzati fuq iż- żewġ naħat, immarkati GXLL7 fuq naħa waħda.
Telzir in combination with low dose ritonavir is indicated for the treatment of Human Immunodeficiency Virus Type 1 (HIV-1) infected adults, adolescents and children of 6 years and above in combination with other antiretroviral medicinal products.
4. 1 Indikazzjonijiet terapewtiċi
In moderately antiretroviral experienced adults, Telzir in combination with low dose ritonavir has not been shown to be as effective as lopinavir / ritonavir.
F’ adulti li diġà ngħataw ammonti moderati ta ’ antiretrovirali, Telzir flimkien ma ’ doża żgħira ta ’ ritonavir ma weriex l- istess effikaċja ta ’ lopinavir / ritonavir.
No comparative studies have been undertaken in children or adolescents.
Ma sarux studji komparattivi fi tfal jew adolexxenti.
In heavily pretreated patients the use of Telzir in combination with low dose ritonavir has not been sufficiently studied.
F’ pazjenti li ngħataw kura qawwija minn qabel, l- użu ta ’ Telzir flimkien ma ’ doża żgħira ta ’ ritonavir ma ġiex studjat biżżejjed.
In protease inhibitor (PI) experienced patients the choice of Telzir should be based on individual viral resistance testing and treatment history (see section 5.1).
F’ pazjenti li diġà ngħataw l- impeditur protease (PI) l- għażla ta ’ Telzir trid tkun ibbażata fuq it- testijiet tar- reżistenza għal virus ta ’ l- individwu, u l- kura li kien ingħata qabel (ara sezzjoni 5. 1).
Telzir must only be given with low dose ritonavir as a pharmacokinetic enhancer of amprenavir and in combination with other antiretroviral medicinal products.
Telzir għandu jingħata biss ma ’ doża żgħira ta ’ ritonavir bħala enħanser farmakokinetiku ta ’ amprenavir u flimkien ma ’ prodotti mediċinali antiretrovirali oħrajn.
The Summary of Product Characteristics of ritonavir must therefore be consulted prior to initiation of therapy with Telzir.
Is- Sommarju tal- Karatteristiċi tal- Prodott ta ’ ritonavir għandu għalhekk jinqara bir- reqqa qabel tinbeda l- kura b’ Telzir
Therapy should be initiated by a physician experienced in the management of HIV infection.
It- terapija għandha tinbeda minn tabib li għandu esperjenza fil- qasam tal- kura ta ’ l- infezzjoni ta ’ HIV.
Telzir (fosamprenavir) is a pro-drug of amprenavir and must not be administered concomitantly with other medicinal products containing amprenavir.
Telzir (fosamprenavir) huwa pro- droga ta ’ amprenavir u m’ għandux jingħata fl- istess ħin ma ’ prodotti mediċinali oħra li jkun fihom amprenavir.
The importance of complying with the full recommended dosing regimen should be stressed to all patients.
L- importanza li l- pazjenti kollha jsegwu eżatt ir- reġimen kif rakkomandat mit- tabib trid tiġi emfasizzata.
2 Caution is advised if the recommended doses of Telzir with ritonavir detailed below are exceeded (see section 4.4).
Għandha tiġi irrikkmandata l- kawtela jekk il- limiti tad- dożi ta ’ Telzir ma ’ ritonavir irrakkomandati hawn taħt jinqabżu (ara sezzjoni 4. 4).
Telzir tablet is administered orally.
2 Il- pillola ta ’ Telzir tingħata mill- ħalq.
Telzir tablet can be taken with or without food.
Il- pillola ta ’ Telzir tista ’ tittieħdu bi jew mingħajr ikel.
Telzir is also available as an oral suspension for use in patients unable to swallow tablets, and in paediatric patients less than 39 kg (please refer to the Summary of Product Characteristics for Telzir oral suspension).
Telzir issibu wkoll bħala sospensjoni li tittieħed mill- ħalq għall- użu f’ pazjenti li ma jistgħux jibilgħu pilloli, u pazjenti pedjatriċi li jiżnu anqas minn 39kg (jekk jogħġbok irreferi għas- Sommarju tal - Karatteristiċi tal- Prodott għas- sospensjoni orali ta ’ Telzir.
The recommended dose is 700 mg fosamprenavir twice daily with 100 mg ritonavir twice daily.
Id- doża rakkomandata hi ta ’ 700 mg fosamprenavir darbtejn kuljum ma ’ 100 mg ritonavir darbtejn kuljum.
Paediatric patients from 6 years of age
Pazjenti pedjatriċi mill- eta ’ ta ’ 6 snin
The adult dose of Telzir tablet 700 mg twice daily with ritonavir 100 mg twice daily may be used in children weighing at least 39 kg and able to swallow tablets.
Id- doża tal- pilloli ta ’ Telzir għall- kbar (700mg darbtejn kuljum ma ’ ritonavir 100mg darbtejn kuljum) tista ’ tintuża fit- tfal li jiżnu 39 kilo jew aktar u jibilgħu il- pilloli sħaħ.
For children weighing less than 39 kg, Telzir oral suspension is the recommended option for the most accurate dosing in children based on body weight (please refer to the Summary of Product Characteristics for Telzir oral suspension).
Għal tfal li jiżnu anqas minn 39 kilo, is- sospensjoni orali ta’ Telzir hija l- għażla rakkomandata għall - aktar dożaġġ eżatt fit- tfal ibbażat fuq il- piż tal- ġisem (jekk jogħġbok irreferi għas- Sommarju tal - Karatteristiċi tal- Prodott għas- sospensjoni orali ta ’ Telzir).
Children less than 6 years of age:
Tfal ta ’ anqas minn 6 snin:
Telzir with ritonavir is not recommended in children below 6 years due to insufficient data on pharmacokinetics, safety and antiviral response (see section 5.2).
Telzir ma ’ ritonavir m’ huwiex rakkomandat fi tfal taħt is- 6 snin minħabba li m' hemmx informazzjoni biżżejjed fuq farmakokinetika, sigurtà u rispons antivirali (ara sezzjoni 5. 2).
Elderly (over 65 years of age)
Anzjani (’ l fuq minn 65 sena)
The pharmacokinetics of fosamprenavir have not been studied in this patient population (see section 5.2).
Il- farmakokinetiċi ta ’ fosamprenavir ma ġewx studjati f’ dan il- grupp ta ’ pazjenti (ara sezzjoni 5. 2).
No initial dose adjustment is considered necessary in patients with renal impairment (see section 5.2).
M’ hemmx bżonn ta ’ tibdil fid- doża għal pazjenti li għandhom indeboliment tal- kliewi (ara sezzjoni 5. 2).
For adults with mild hepatic impairment (Child-Pugh score:
Id- doża rakkomandata għall- adulti b’ indeboliment tal- fwied ħafif (Child- Pugh score:
5-6) the recommended dose is 700 mg fosamprenavir twice daily with 100 mg ritonavir once daily.
5- 6) hija ta ’ 700 mg fosamprenavir darbtejn kuljum ma ’ 100 mg ritonavir darba kuljum.
For adults with moderate hepatic impairment (Child-Pugh score:
Id- doża rakkomandata għall- adulti b’ indeboliment tal- fwied moderat (Child- Pugh score:
7-9) the recommended dose is 450 mg fosamprenavir twice daily with 100 mg ritonavir once daily.
7- 9) hija ta ’ 450 mg fosamprenavir darbtejn kuljum ma ’ 100 mg ritonavir darba kuljum.
As it is not possible to achieve this fosamprenavir dose using the tablet formulation, these patients should be treated with fosamprenavir oral suspension.
Minħabba li mhux possibli li din id- doża tintlaħaq bl- użu tal- pilloli, dawn il- pazjenti għandhom jirċievu t- trattament permezz ta 'sospensjoni orali ta' fosamprenavir.
For adults with severe hepatic impairment (Child-Pugh score:
Għal adulti b’ indeboliment sever tal- fwied (Child- Pugh score:
10-15): fosamprenavir should be used with caution and at a reduced dose of 300 mg fosamprenavir twice daily with 100 mg ritonavir once daily.
10- 15): fosamprenavir għandu jintuża b’ kawtela u f' dożi mnaqqsa ta ’ 300mg fosamprenavir darbtejn kuljum ma ’ 100mg ritonavir darba kuljum.
As it is not possible to achieve this fosamprenavir dose using the tablet formulation, these patients should be treated with fosamprenavir oral suspension.
Billi mhux possibli li tasal għal din id- doża ta ’ fosamprenavir billi tuża il- formulazzjoni tal - pilloli, dawn il- pazjenti għandhom ikunu kkurati bis- sospensjoni orali ta ’ fosamprenavir.
Even with these dose adjustments for adults, some patients with hepatic impairment may have higher or lower than anticipated amprenavir and/ or ritonavir plasma concentrations as compared to patients with normal hepatic function, due to increased inter-patient variability (see section 5.2), therefore a close monitoring of safety and virologic response is warranted.
Ukoll b’ dawn l- aġġustamenti fid- doża f’ adulti, xi pazjenti b’ indebboliment tal- fwied jista ’ jkollhom konċentrazzjonijiet aktar għolja jew baxxi ta ’ amprenavir jew/ u ritonavir fil- plażma milli mistenni meta mqabbla ma ’ pazjenti b’ funzjoni normali tal- fwied, minħabba varjeta ’ akbar bejn pazjent u ieħor (ara sezzjoni 5. 2), għalhekk huwa indikat monitoraġġ mill- qrib tar- rispons tas- sigurta ’ u viroloġika.
3 No dose recommendation can be made for children and adolescents with hepatic impairment as no studies have been conducted in these age groups.
3 Ma jistgħux isiru rakkomandazzjonijiet ta ’ doża għal tfal u adolexxenti b’ indebboliment tal- fwied billi ma sarux studji f’ dawn il- gruppi ta 'eta ’
Hypersensitivity to fosamprenavir, amprenavir or to any of the excipients of Telzir, or to ritonavir.
Ipersensittività għal fosamprenavir, amprenavir jew għal xi sustanzi mhux attivi ta ’ Telzir, jew għal ritonavir.
Telzir must not be administered concurrently with medicinal products with narrow therapeutic windows that are substrates of cytochrome P450 3A4 (CYP3A4), e. g. amiodarone, astemizole, bepridil, cisapride, dihydroergotamine, ergotamine, pimozide, quinidine, terfenadine, oral midazolam (for caution on parenterally administered midazolam, see section 4.5), oral triazolam.
Telzir m’ għandux jingħata fl- istess ħin ma ’ prodotti mediċinali b’ windows terapewtiċi dojoq li huma substrati taċ- citokromju P450 3A4 (CYP3A4), e. g. amiodarone, astemizole, bepridil, cisapride, dihydroergotamine, ergotamine, pimozide, quinidine, terfenadine, midazolam mill- ħalq (kawtela meta midazolam jingħata mill- vina ara sezzjoni 4. 5), triazolam mill- ħalq.
Telzir with ritonavir must not be co-administered with medicinal products with narrow therapeutic windows that are highly dependent on CYP2D6 metabolism, e. g. flecainide and propafenone (see section 4.5).
Telzir ma ’ ritonavir m’ għandhomx jingħataw fl- istess ħin ma ’ prodotti mediċinali b’ therapeutic windows dojoq li jiddependu ħafna mill- metaboliżmu ta ’ CYP2D6, e. ż. flecainide, u propafenone (ara sezzjoni 4. 5).
(see section 4.5).
Il- kombinazzjoni ta ’ rifampicin ma ’ Telzir flimkien ma ’ doża baxxa ta ’ ritonavir hija kontraindikata (ara sezzjoni 4. 5)
Herbal preparations containing St John’ s wort (Hypericum perforatum) must not be used while taking Telzir due to the risk of decreased plasma concentrations and reduced clinical effects of amprenavir (see section 4.5).
Preparazzjonijiet tal- ħxejjex li fihom St John’ s wort (Hypericum perforatum) m’ għandhomx jintużaw fl- istess waqt li qed jintuża Telzir minħabba r- riskju ta ’ tnaqqis fil- konċentrazzjoni fil- plażma u fl - effetti klinici mnaqqsa ta ’ amprenavir (ara sezzjoni 4. 5).
Patients should be advised that treatment with Telzir, or any other current antiretroviral therapy, does not cure HIV and that they may still develop opportunistic infections and other complications of HIV infection.
Il- pazjenti għandhom jigu mgħarrfa li kura b’ Telzir, jew kull xorta ta ’ terapija antiretrovirali li teżisti bħalissa, ma jfejjaqx l- HIV u li xorta waħda jistgħu jiżviluppaw infezzjonijiet opportunistiċi u komplikazzjonijiet oħra marbuta ma ’ l- HIV.
Current antiretroviral therapies, including Telzir, have not been proven to prevent the risk of transmission of HIV to others through sexual contact or blood contamination.
Bħalissa, m’ hemmx provi li terapija antiretrovirali inkluż Telzir tnaqqas ir- riskju tat- tixrid tal- HIV permezz ta ’ kuntatti sesswali jew kontaminazzjoni mid - demm.
Appropriate precautions should continue to be taken.
Kull prekawzjoni possibbli għandha tibqa ’ tittieħed.
Fosamprenavir contains a sulphonamide moiety.
Fosamprenavir fih nofs li tikkonsisti f’ sulphonamide.
The potential for cross-sensitivity between medicinal products in the sulphonamide class and fosamprenavir is unknown.
Il- potenzjal ta ’ cross sensitivity bejn prodotti mediċinali tal- klassi tas- sulphonamides u fosamprenavir mhux magħruf.
In the pivotal studies of Telzir, in patients receiving fosamprenavir with ritonavir there was no evidence of an increased risk of rashes in patients with a history of sulphonamide allergy versus those who did not have a sulphonamide allergy.
Fi studji pivotali dwar Telzir, f’ pazjenti li qed jieħdu fosamprenavir ma ’ ritonavir ma kien hemm l- ebda evidenza ta ’ riskju akbar ta ’ raxx f’ pazjenti b’ passat ta ’ allergiji għas- sulfonamidi meta mqabbla ma ’ dawk li ma kellhomx allerġiji għas- sulphonamides.
Yet, Telzir should be used with caution in patients with a known sulphonamide allergy.
Madankollu, Telzir għandu jintuża b’ prekawzjoni f’ pazjenti magħrufa li jsofru minn allerġija għas- sulphonamides.
Co-administration of Telzir 700 mg twice daily with ritonavir in doses greater than 100 mg twice daily has not been clinically evaluated.
L- użu ta ’ Telzir 700 mg darbtejn kuljum ma ’ ritonavir f’ dożi akbar minn 100 mg darbtejn kuljum ma ġiex evalwat klinikament.
The use of higher ritonavir doses might alter the safety profile of the combination and therefore is not recommended.
L- użu ta ’ doża akbar ta ’ ritonavir jista ’ jkollha effett fuq is- sigurtà ta ’ din it - terapija kombinata u għalhekk dan mhux rakkomandat.
Liver disease
Mard tal- Fwied
Telzir with ritonavir should be used with caution and at reduced doses in adults with mild, moderate, or severe hepatic impairment (see section 4.2. Patients with chronic hepatitis B or C and treated with combination antiretroviral therapy are at an increased risk of severe and potentially fatal hepatic adverse events.
Pazjenti bl- epatite B jew C kronika u li jingħataw terapija antiretrovirali kombinata jinsabu f’ riskju akbar li jsofru minn reazzjonijiet epatiċi avversi severi u li jistgħu jkunu fatali.