qanastek/EMEA-V3 huggingface dataset:
1.9% for placebo) of serum potassium concentration (≥ 6.0 mmol/ l), although this was not statistically significant.
16 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 Enviage on mortality and cardiovascular morbidity and target organ damage are currently unknown.
L- effetti benefiċi ta ’ Enviage fuq il- mortalità jew morbidità kardjovaskulari u l- ħsara fl- organu milqut bħalissa mhumhiex magħrufa.
These observed changes, however, did not correlate with the severity of renal impairment.
AUC u Cmax relattivi ta ’ aliskiren f’ individwi b’ indeboliment renali kellhom medda ta ’ bejn 0. 8 sa darbtejn il - livelli f’ individwi b’ saħħithom wara li ngħatat doża waħda u fi stat fiss.
The pharmacokinetics of aliskiren were not significantly affected in patients with mild to severe liver disease.
Dawn il- bidliet li dehru, madankollu, ma kienux jikkorrelataw mas- severità ta ’ l- indeboliment renali.
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 ’ Enviage f’ pazjenti b’ indeboliment renali ħafif għal sever, iżda għandha tingħata attenzjoni f’ pazjenti b’ indeboliment renali sever.
17 5.3 Preclinical safety data
17 Il- farmakokinetika ta ’ aliskiren ma nbidlitx b’ mod sinifikanti f’ pazjenti b’ mard tal- fwied ħafif għal sever.
6.4 Special precautions for storage
18 6. 4 Prekawzjonijiet speċjali għall- ħażna
18 6.5 Nature and contents of container
6. 5 In- natura tal- kontenitur u ta ’ dak li hemm ġo fih
Packs containing 84 (3x28), 90 (3x30), 98 (2x49) or 280 (20x14) tablets are multi-packs.
Pakketti li jkun fihom 84 (3x28), 90 (3x30), 98 (2x49) jew 280 (20x14) pillola huma pakketti b’ ħafna.
19 ANNEX II
19 ANNESS II
Via Provinciale Schito 131 I-80058 Torre Annunziata/ NA Italy
Via Provinciale Schito 131 I- 80058 Torre Annunziata/ NA L- Italja
Pharmacovigilance system The MAH must ensure that the system of pharmacovigilance, as described in version 2 (dated 5 July 2006) presented in Module 1.8.1. of the Marketing Authorisation Application, is in place and functioning before and whilst the product is on the market.
Sistema ta ’ farmakoviġilanza L- MAH għandu jaċċerta ruħu li s- sistema ta ’ farmakoviġilanza, kif deskritta fil- verżoni 2 (data 5 Lulju 2006) li hemm f’ Modulu 1. 8. 1 ta ’ l- Applikazzjoni għall- Awtorizzazzjoni Għat- Tqegħid fis - Suq, tkun twaqqfet u qed taħdem qabel u waqt li l- prodott ikun fis- suq.
Risk Management Plan The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in version 30 May 2007 of the Risk Management Plan (RMP) presented in Module 1.8.2. of the Marketing Authorisation Application and any subsequent updates of the RMP agreed by the CHMP.
Pjan ta ’ l- Immaniġġar tar- Riskju L- MAH jintrabat sabiex iwettaq l- istudji u attivitajiet oħra ta ’ farmakoviġilanza kif hemm fid- dettal fil- Pjan ta ’ Farmakoviġilanza, kif miftiehem fil- verżjoni tat- 30 Mejju 2007 tal- Pjan ta ’ l- Immaniġġar tar- Riskju (RMP) li hemm f’ Modulu 1. 8. 2 ta ’ l- Applikazzjoni Għall- Awtorizzazzjoni Għat- Tqegħid fis- Suq u kwalunkwe aġġornament sussegwenti ta ’ l- RMP miftiehem mis- CHMP.
As per the CHMP Guideline on Risk Management Systems for medicinal products for human use, the updated RMP should be submitted at the same time as the next Periodic Safety Update Report (PSUR).
Skond il- Linja Gwida tas- CHMP dwar Is- Sistemi ta ’ l- Immaniġġar tar- Riskju għall- prodotti mediċinali għall- użu fil- bniedem, l- RMP imġedded għandu jiġi sottomess fl- istess ħin mar- Rapport Perjodiku dwar is- Sigurtà Aġġornat (PSUR).
In addition, an updated RMP should be submitted • When new information is received that may impact on the current Safety Specification, Pharmacovigilance Plan or risk minimisation activities. • Within 60 days of an important (pharmacovigilance or risk minimisation) milestone being reached. • At the request of the EMEA.
Minbarra hekk, RMP aġġornat għandu jkun sottomess • Meta tasal informazzjoni li jista ’ jkollha impatt fuq l- Ispeċifikazzjoni kurrenti dwar is- Sigurtà, Pjan ta ’ Farmakoviġilanza jew attivitajiet sabiex ikun imnaqqas għall- minimu r- riskju. • Fi żmien 60 jum minn meta jintlaħaq avveniment importanti (farmakoviġilanza jew tnaqqis tar - riskju għall- minimu) • Fuq talba ta ’ l- EMEA.
21 ANNEX III
21 ANNESS III
FOLDING BOX FOR UNIT PACK
KAXXA LI TINTLEWA GĦAL PAKKETT B’ WIEĦED
Enviage 150 mg film-coated tablets Aliskiren
Enviage 150 mg pilloli miksijin b’ rita Aliskiren
7 film-coated tablets 14 film-coated tablets 28 film-coated tablets 30 film-coated tablets 50 film-coated tablets 56 film-coated tablets 90 film-coated tablets
7 pilloli miksijin b’ rita 14- il pillola miksija b’ rita 28 pillola miksija b’ rita 30 pillola miksija b’ rita 50 pillola miksija b’ rita 56 pillola miksija b’ rita 90 pillola miksija b’ rita
25 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
25 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI
BLISTER BLISTER (CALENDAR)
FOLJA FOLJA (KALENDARJU)
Monday Tuesday Wednesday Thursday Friday Saturday Sunday
It- Tnejn It- Tlieta L- Erbgħa Il- Ħamis Il- Ġimgħa Is- Sibt Il- Ħadd
26 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
26 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
INTERMEDIATE CARTON OF MULTIPACKS (WITHOUT BLUE BOX)
KARTUNA TAN- NOFS TAL- PAKKETTI B’ ĦAFNA (MINGĦAJR IL_ KAXXA ĊELESTI)
14 film-coated tablets Component of a multipack comprising 20 packs, each containing 14 tablets.
14 pillola miksija b’ rita Jagħmel parti minn pakkett b’ ħafna li jkun fih 20 pakkett, kull wieħed ikun fih 14- il pillola.
28 film-coated tablets Component of a multipack comprising 3 packs, each containing 28 tablets.
28 pillola miksija b’ rita Jagħmel parti minn pakkett b’ ħafna li jkun fih 3 pakketti, kull wieħed ikun fih 28 pillola.
49 film-coated tablets Component of a multipack comprising 2 packs, each containing 49 tablets.
49 pillola miksija b’ rita Jagħmel parti minn pakkett b’ ħafna li jkun fih 2 pakketti, kull wieħed ikun fih 49 pillola.
Store in the original package in order to protect from moisture.
Aħżen fil- pakkett oriġinali sabiex tilqa mill- umdità.
84 film-coated tablets (3x28) 98 film-coated tablets (2x49) 280 film-coated tablets (20x14)
84 pillola miksija b’ rita (3x28) 98 pillola miksija b’ rita (2x49) 280 pillola miksija b’ rita (20x14)
28 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
28 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
OUTER CARTON OF MULTIPACKS (INCLUDING BLUE BOX)
KARTUNA TA ’ BARRA TAL- PAKKETTI B’ ĦAFNA (INKLUŻA L- KAXXA Ċ- ĊELESTI)
84 film-coated tablets Multipack comprising 3 packs, each containing 28 tablets.
84 pillola miksija b’ rita Pakkett b’ ħafna li jkun fih 3 pakketti, kull wieħed ikun fih 28 pillola.
98 film-coated tablets Multipack comprising 2 packs, each containing 49 tablets.
98 pillola miksija b’ rita Pakkett b’ ħafna li jkun fih 2 pakketti, kull wieħed ikun fih 49 pillola.
280 film-coated tablets Multipack comprising 20 packs, each containing 14 tablets.
Pakkett b’ ħafna li jkun fih 20 pakkett, kull wieħed ikun fih 14- il pillola.
Enviage 300 mg film-coated tablets Aliskiren
Enviage 300 mg pilloli miksijin b’ rita Aliskiren
Each film-coated tablet contains 300 mg aliskiren (as hemifumarate).
Kull pillola miksija b’ rita fiha 300 mg aliskiren (bħala hemifumarate).
7 film-coated tablets 14 film-coated tablets 28 film-coated tablets 30 film-coated tablets 50 film-coated tablets 56 film-coated tablets
7 pilloli miksijin b’ rita 14- il pillola miksija b’ rita 28 pillola miksija b’ rita 30 pillola miksija b’ rita 50 pillola miksija b’ rita 56 pillola miksija b’ rita
32 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
32 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI
30 film-coated tablets Component of a multipack comprising 3 packs, each containing 30 tablets.
30 pillola miksija b’ rita Jagħmel parti minn pakkett b’ ħafna li jkun fih 3 pakketti, kull wieħed ikun fih 30 pillola.
84 film-coated tablets (3x28) 90 film-coated tablets (3x30) 98 film-coated tablets (2x49) 280 film-coated tablets (20x14)
84 pillola miksija b’ rita (3x28) 90 pillola miksija b’ rita (3x30) 98 pillola miksija b’ rita (2x49) 280 pillola miksija b’ rita (20x14)
90 film-coated tablets Multipack comprising 3 packs, each containing 30 tablets.
90 pillola miksija b’ rita Pakkett b’ ħafna li jkun fih 3 pakketti, kull wieħed bi 30 pillola.
38 PACKAGE LEAFLET:
38 FULJETT TA ’ TAGĦRIF:
What Enviage is and what it is used for 2.
X’ inhu Enviage u għalxiex jintuża 2.
Before you take Enviage 3.
Qabel ma tieħu Enviage 3.
How to take Enviage 4.
Kif għandek tieħu Enviage 4.
How to store Enviage 6.
Kif taħżen Enviage 6.
WHAT ENVIAGE IS AND WHAT IT IS USED FOR
X’ INHU ENVIAGE U GĦALXIEX JINTUŻA
Enviage belongs to a new class of medicines called renin inhibitors.
Rasliez jagħmel parti minn klassi ġdida ta ’ mediċini li jissejjħu inibituri ta ’ renin.
Enviage helps to lower high blood pressure.
Enviage jgħin biex ibaxxi l- pressjoni tad- demm għolja.
Renin inhibitors reduce the amount of angiotensin II the body can produce.
Inibituri ta ’ renin inaqqsu l- ammont ta ’ angiotensin II li l- ġisem jista ’ jipproduċi.
Angiotensin II causes blood vessels to tighten, which increases the blood pressure.
B’ angiotensin II il- vini tad- demm jidjiequ u l- pressjoni tad- demm togħla.
Reducing the amount of angiotensin II allows the blood vessels to relax, which lowers blood pressure.
Bit- tnaqqis ta ’ angiotensin II, il- vini tad- demm jistrieħu, u l- pressjoni tad- demm titbaxxa.
High blood pressure increases the workload of the heart and arteries.
Pressjoni tad- demm għolja iżżid l- ammont ta ’ xogħol fuq il- qalb u l- arterji.
If this continues for a long time, it can damage the blood vessels of the brain, heart and kidneys, and may result in a stroke, heart failure, heart attack or kidney failure.
Jekk dan idum għal żmien twil, jista ’ jagħmel il- ħsara fil- vini tad- demm fil- moħħ, qalb u kliewi, u jista ’ jikkawża puplesija, insuffiċjenza tal- qalb, attakk tal- qalb jew insuffiċjenza tal- kliewi.
Lowering the blood pressure to a normal level reduces the risk of developing these disorders.
Billi tbaxxi l- pressjoni tad- demm għall- livelli normali jitnaqqas ir- riskju li tiżviluppa dawn id- disturbi.
BEFORE YOU TAKE ENVIAGE
QABEL MA TIEĦU ENVIAGE
Do not take Enviage
Tieħux Enviage
If you
- jekk inti allerġiku/ a (tbati minn sensittività eċċessiva) għal aliskiren jew sustanzi oħra ta ’
think you may be allergic, ask your doctor for advice.
Jekk taħseb li tista ’ tkun allerġiku, staqsi lit- tabib tiegħek għal parir.
- during the last 6 months of pregnancy or if you are breast-feeding, see section Pregnancy and
- fl- aħħar 6 xhur tat- tqala jew jekk qed tredda ’, ara sezzjoni Tqala u treddigħ.
- if you are taking ciclosporin (a medicine used in transplantation to prevent organ rejection or for
- jekk qed tieħu ciclosporin (mediċina li tintuża f’ każ ta ’ trapjant sabiex jiġi evitat li l- organu jiġi
other conditions, e. g. rheumathoid arthritis or atopic dermatitis) or verapamil (a medicine used to lower blood pressure, to correct hearth rhythm or to treat angina pectoris) or quinidine (a medicine used to correct heart rhythm).
riġettat jew għal kundizzjonijiet oħra, eż artrite rewmatojde jew dermatite atopika) jew verapamil (mediċina li tintuża biex tbaxxi l- pressjoni tad- demm, biex tirranġa r- ritmu tal- qalb jew għall- kura ta ’ anġina pektoris) jew quinidine (mediċina li tintuża biex tirranġa r- ritmu tal - qalb).
Take special care with Enviage
Oqgħod attent ħafna b’ Enviage
- if you are taking a diuretic (a type of medicine also known as “ water ” tablets which increases
- jekk qed tieħu dijuretiku (tip ta ’ mediċina magħrufa bħala pilloli “ tal- pipi ” li jżidu l- ammont ta ’
the amount of urine you produce).
awrina li tagħmel).
- if you have impaired kidney function.
- jekk għandek insuffiċjenza tal- funzjoni tal- kliewi.
If any of these apply to you, tell your doctor before you take Enviage.
Jekk xi wieħed minn dawn jgħodd għalik, għid lit- tabib tiegħek qabel tieħu Enviage.
The use of Enviage in children and adolescents is not recommended.
L- użu ta ’ Enviage fi tfal u adolexxenti mhux rakkomandat.
There are no special dose recommendations for patients aged 65 years or older.
M’ hemmx rakkomandazzjonijiet speċjali għal pazjenti li għandhom 65 sena jew akbar.
39 Using other medicines Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
39 Meta tuża mediċini oħra Jekk jogħġbok għid lit- tabib jew lill- ispiżjar tiegħek jekk qiegħed tieħu jew ħadt dan l- aħħar xi mediċini oħra, anki dawk mingħajr riċetta.
Your doctor may need to change your dose and/ or to take other precautions if you are taking one of the following medicines:
It- tabib tiegħek jista ’ jkollu bżonn jibdillek id- doża u/ jew jieħu xi prekawzjonijiet oħra jekk qed tieħu xi waħda mill- mediċini li ġejjin:
- medicines that increase the amount of potassium in your blood.
- mediċini li jżidu l- ammont ta ’ potassium fid- demm tiegħek.
These include potassium-
Dawn jinkludu dijuretiċi li jfaddlu l -
sparing diuretics, potassium supplements.
potassium, sustanzi tal- potassium.
- furosemide, a medicine belonging to the type known as diuretics, or “ water” tablets, which is
- furosemide, mediċina li tagħmel parti minn dawk magħrufin bħala dijuretiċi, jew pilloli “ tal -
used to increase the amount of urine you produce.
pipi ”, li jintużaw biex jiżdied l- ammont ta ’ awrina li tagħmel.
- ketoconazole, a medicine used to treat fungal infections.
- ketoconazole, mediċina li tintuża biex tikkura infezzjonijiet tal- fungu.
Taking Enviage with food and drink You should take Enviage with a light meal once a day, preferably at the same time each day.
Meta tieħu Enviage ma ’ l- ikel u max- xorb Għandek tieħu Enviage ma ’ ikla ħafifa darba kuljum, l- aħjar fl- istess ħin kuljum.
You should not take Enviage together with grapefruit juice.
M’ għandekx tieħu Enviage mal- meraq tal- grejpfrut.
Pregnancy and breast-feeding Do not take Enviage if you are pregnant.
Tqala u treddigħ Tieħux Enviage jekk ħriġt tqila.
It is important to talk to your doctor immediately if you think you may be pregnant or are planning to become pregnant.
Huwa importanti li tkellem lit- tabib tiegħek mill- ewwel jekk taħseb li tista ’ tkun ħriġt tqila jew qed tippjana biex toħroġ tqila.
Do not breast-feed if you are taking Enviage.
Treddax jekk qed tieħu Enviage.
Driving and using machines You may feel dizzy and this can affect your ability to concentrate.
Sewqan u tħaddim ta ’ magni Tista ’ tħossok sturdut u dan jista ’ jeffettwa l- ħila tiegħek biex tikkonċentra.
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 Enviage.
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 ’ Enviage.
HOW TO TAKE ENVIAGE
KIF GĦANDEK TIEĦU ENVIAGE
Always take Enviage exactly as your doctor has told you.
Dejjem għandek tieħu Enviage skond il- parir eżatt tat- tabib.
People who have high blood pressure often do not notice any signs of the problem.
Nies li jkolhom il- pressjoni tad- demm għolja ħafna drabi ma jinnutaw l- ebda sinjal tal- problema.
Many may feel quite normal.
Ħafna nies iħossuhom normali.
It is very important that you take this medicine exactly as your doctor tells you to get the best results and reduce the risk of side effects.
Huwa importanti ħafna li tieħu din il- mediċina eżattament kif jgħidlek it- tabib tiegħek sabiex tikseb l- aqwa riżultati u tnaqqas ir- riskju li jkollok effetti sekondarji.
Keep your appointments with the doctor even if you are feeling well.
Żomm l - appuntamenti mat- tabib tiegħek anki jekk tkun qed tħossok tajjeb.
The usual starting dose is one 150 mg tablet once daily.
Id- doża tal- bidu s- soltu tkun pillola waħda tal- 150 mg darba kuljum.
Depending on how you respond to the treatment your doctor may prescribe a higher dose of one 300 mg tablet once daily.
Skond kif ikun ir- rispons tiegħek għall- kura t- tabib tiegħek jista ’ jordnalek doża ogħla ta ’ pillola ta ’ 300 mg darba kuljum.
Your doctor may prescribe Enviage together with other medicines used to treat high blood pressure.
It- tabib tiegħek jista ’ jordnalek Enviage ma ’ mediċini oħra li jintużaw biex jikkuraw il- pressjoni tad- demm għolja.
Method of administration It is recommended that you take the tablets with some water.
Kif għandu jingħata Huwa rakkomandat li tieħu l- pilloli ma ’ xi ftit ilma.
You should take Enviage with a light meal once a day, preferably at the same time each day.
Għandek tieħu Enviage ma ’ ikla ħafifa darba kuljum, l- aħjar fl- istess ħin kuljum.
You should not take Enviage together with grapefruit juice.
M’ ghandekx tieħu Enviage mal- meraq tal- grejpfrut.
If you take more Enviage than you should If you have accidentally taken too many Enviage tablets, consult a doctor immediately.
Jekk tieħu Enviage aktar milli suppost Jekk bi żball ħadt wisq pilloli Enviage, ikkonsulta mat- tabib tiegħek minnufih.
You may require medical attention.
Jista ’ jkollok bżonn attenzjoni medika.
40 If you forget to take Enviage If you forget to take a dose of Enviage, take it as soon as you remember and then take the next dose at its usual time.
Jekk tinsa tieħu Enviage Jekk tinsa tieħu doża ta ’ Enviage, ħudha hekk kif tiftakar u imbagħad ħu d- doża li jmissek fil- ħin tas - soltu.
However, if it is almost time for your next dose you should simply take the next tablet at the usual time.
Iżda, jekk ikun kważi wasal il- ħin tad- doża li jmissek għandek sempliċement tieħu l- pillola li jkun imissek fil- ħin tas- soltu.
Do not take a double dose to make up for a forgotten dose.
M’ għandekx tieħu doża doppja biex tpatti għad- doża li tkun insejt tieħu.
Like all medicines, Enviage can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, Enviage jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
Common (affecting less than 1 in 10 patients):
Effetti komuni (jeffettwaw anqas minn 1 f’ kull 10 pazjenti):
Diarrhoea.
Dijarrea.
Uncommon (affecting less than 1 in 100 patients):
Mhux komuni (jeffettwaw anqas minn 1 f’ kull 100 pazjent):
Skin rash.
Raxx tal- ġilda.
HOW TO STORE ENVIAGE
KIF TAĦŻEN ENVIAGE
Do not use Enviage after the expiry date which is stated on the carton and blister.
Tużax Enviage wara d- data ta ’ skadenza li tidher fuq il- kartuna u l- folja.
What Enviage contains
X’ fih Enviage
- The active substance is aliskiren (as hemifumarate) 150 mg.
- Is- sustanza attiva hi aliskiren (bħala hemifumarate) 150 mg.
- The other ingredients are crospovidone, hypromellose, magnesium stearate, macrogol,
- Is- sustanzi l- oħra huma crospovidone, hypromellose, magnesium stearate, macrogol,
microcrystalline cellulose, povidone, colloidal anhydrous silica, talc, titanium dioxide (E 171), black iron oxide (E 172), red iron oxide (E 172).
microcrystalline cellulose, povidone, colloidal anhydrous silica, talc, titanium dioxide (E 171), black iron oxide (E 172), red iron oxide (E 172).
What Enviage looks like and contents of the pack Enviage 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 ’ Enviage u l- kontenuti tal- pakkett Enviage 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.
Enviage is available in packs containing 7, 14, 28, 30, 50, 56, 84, 90, 98 or 280 tablets.
Enviage jiġi f’ pakketti li jkun fihom 7, 14, 28, 30, 50, 56, 84, 90, 98 jew 280 pillola.
Packs containing 84 (3x28), 98 (2x49) or 280 (20x14) tablets are multi-packs.
Pakketti li fihom 84 (3x28), 98 (2x49) jew 280 (20x14) pillola huma pakketti b’ ħafna.
Not all pack sizes may be available in your country.
Jista ’ jkun li mhux il- pakketti kollha jkunu għal skop kummerċjali f’ pajjiżek.
Manufacturer Novartis Farma S. p. A.
Manifattur Novartis Farma S. p. A.
43 PACKAGE LEAFLET:
43 FULJETT TA ’ TAGĦRIF:
- if you are taking a diuretic (a type of medicine also known as “ water” tablets which increases
- jekk qed tieħu dijuretiku (tip ta ’ mediċina magħrufa bħala pilloli “ tal- pipi ” li jżidu l- ammont ta ’
44 Using other medicines Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
44 Meta tuża mediċini oħra Jekk jogħġbok għid lit- tabib jew lill- ispiżjar tiegħek jekk qiegħed tieħu jew ħadt dan l- aħħar xi mediċini oħra, anki dawk mingħajr riċetta.
45 If you forget to take Enviage If you forget to take a dose of Enviage, take it as soon as you remember and then take the next dose at its usual time.
45 Jekk tinsa tieħu Enviage Jekk tinsa tieħu doża ta ’ Enviage, ħudha hekk kif tiftakar u imbagħad ħu d- doża li jmissek fil- ħin tas - soltu.
- The active substance is aliskiren (as hemifumarate) 300 mg.
- Is- sustanza attiva hi aliskiren (bhala hemifumarate) 300 mg.
What Enviage looks like and contents of the pack Enviage 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 ’ Enviage u l- kontenuti tal- pakkett Enviage 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.
Packs containing 84 (3x28), 90 (3x30), 98 (2x49) or 280 (20x14) tablets are multi-packs.
Pakketti li fihom 84 (3x28), 90 (3x30), 98 (2x49) jew 280 (20x14) pillola huma pakketti b’ ħafna.
Not all pack sizes may be available in your country.
Jista ’ jkun li mhux il - pakketti kollha jkunu għal skop kummerċjali f’ pajjiżek.
46 For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
46 Għal kull tagħrif dwar din il- mediċina, jekk jogħġbok ikkuntattja lir- rappreżentant lokali tad- Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- Suq:
EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR)
RAPPORT TA ’ VALUTAZZJONI PUBBLIKA EWROPEW (EPAR) EPIVIR
What is Epivir?
X’ inhu Epivir?
Epivir is a medicine containing the active substance lamivudine.
Epivir hija mediċina li fiha s- sustanza attiva lamivudine.
It is available as diamond-shaped tablets (white:
Jiġi f’ għamla ta ’ pilloli f’ forma ta 'djamant (bojod:
150 mg; grey:
150 mg; griżi:
300 mg) and as an oral solution (10 mg/ ml).
300 mg) u bħala soluzzjoni orali (10 mg/ ml).
What is Epivir used for?
Għal xiex jintuża Epivir?
Epivir is an antiviral medicine.
Epivir huwa mediċina antivirali.
It is used in combination with other antiviral medicines to treat adults and children infected with human immunodeficiency virus (HIV), the virus that causes acquired immune deficiency syndrome (AIDS).
Jintuża f’ kombinazzjoni ma ’ mediċini antiretrovirali oħra biex jittratta adulti u tfal infettati bil- virus ta ’ l- immunodefiċjenza umana (HIV), il- virus li jikkaġuna sindromu mill- immunodefiċjenza akkwiżita (AIDS).
How is Epivir used?
Kif jintuża Epivir?
Treatment with Epivir should be initiated by a doctor who has experience in the management of HIV infection.
Trattament b’ Epivir għandu jinbeda minn tabib li għandu l- esperjenza fil- ġestjoni ta ’ infezzjonijiet ta ’ l- HIV.
The recommended dose of Epivir for patients over 12 years of age is 300 mg daily.
Id- doża ta ’ Epivir irrakkomandata għal pazjenti ta ’ ’ l fuq minn 12- il sena hija ta ’ 300 mg kuljum.
In children weighing more than 30 kg, the adult dose of 150 mg twice a day should be used.
Din tista ’ tingħata jew darba kuljum (żewġ pilloli ta ’ 150 mg jew pillola waħda ta ’ 300 mg) jew bħala pillola ta ’ 150 mg darbtejn kuljum.
In children weighing between 14 and 30 kg, the dose depends on body weight.
Fi tfal li jiżnu bejn 14 u 30 kg id- doża tiddependi fuq il- piż tal - ġisem.
Children aged over three months who weigh less than 14 kg should be given the oral solution at a dose of 4 mg per kilogram body weight twice a day, up to a maximum of 300 mg per day.
Tfal ta ’ aktar minn tliet xhur li jiżnu anqas minn 14 kg għandhom jingħataw is- soluzzjoni orali f’ doża ta ’ 4 mg għal kull kilogramma ta ’ piż tal- ġisem darbtejn kuljum, b’ massimu ta ’ 300 mg kuljum.
Epivir tablets should ideally be swallowed without crushing.
Epivir f’ pilloli għandhom jinbelgħu mingħajr ma jitfarrku.
Patients who cannot swallow tablets should use the oral solution, or they may crush and add the tablets to a small amount of food or drink, before taking the dose immediately.
Il- pazjenti li ma jistgħux jibilgħu pilloli għandhom jużaw s- soluzzjoni orali jew jistgħu jidħnu l- pilloli u jżiduhom ma ’ ammont żgħir ta ’ ikel jew xorb, dritt qabel ma jieħdu d- doża.
The dose of Epivir needs to be adjusted in patients who have severe problems with their kidneys.
Id- doża ta ’ Epivir għandha tiġi aġġustata f’ pazjenti li għandhom problemi gravi fil- kliewi tagħhom.
The oral solution can be used to achieve the appropriate dose.
Is - soluzzjoni orali tista ’ tintuża sabiex tikseb id- doża x- xierqa.
Epivir can be taken with or without food.
Epivir jista ’ jittieħed ma ’ l- ikel jew fuq stonku vojt.
For more information, see the Package Leaflet.
Għal aktar tagħrif, ara l- Fuljett ta ’ Tagħrif.
How does Epivir work?
Kif jaħdem Epivir?
The active substance in Epivir, lamivudine, is a nucleoside reverse transcriptase inhibitor (NRTI).
Is- sustanza attiva f’ Epivir, lamivudine, hija inibitur nukleosidiku tat- traskrittrażi inversa (nucleoside reverse transcriptase inhibitor NRTI).
It blocks the activity of reverse transcriptase, an enzyme produced by HIV that allows it to infect cells and make more viruses.
Hija timblokka l- attività tat- traskrittażi inversa, enzima magħmula minn HIV li tħallih jinfetta ċ- ċelloli u jiġġenera aktar virusis.
Epivir, taken in combination with other antiviral medicines, reduces the amount of HIV in the blood and keeps it at a low level.
Epivir, meħud f’ kombinazzjoni ma ’ mediċini antiretrovirali oħra, inaqqas l- ammont ta ’ HIV fid- demm u jżommu
© European Medicines Agency, 2008.
©European Medicines Agency 2008 Reproduction is authorised provided the source is acknowledged f’ livell baxx.
Reproduction is authorised provided the source is acknowledged. but it may delay the damage to the immune system and the development of infections and diseases associated with AIDS.
Epivir ma jikkurax l- infezzjoni ta ’ l- HIV jew l- AIDS, imma jista ’ jittardja l- ħsara għas - sistema immunitarja u l- iżvilupp ta ’ infezzjonijiet u mard assoċjat ma ’ l- AIDS.
How has Epivir been studied?
Kif ġie studjat Epivir?
Epivir has been studied in five main studies involving almost 3,000 adults.
Epivir ġie studjat f’ ħames studji ewlenin li kienu jinvolvu kważi 3, 000 adult.
Four of these studies compared Epivir in combination with zidovudine (another antiviral medicine) to either Epivir or zidovudine alone, or to the combination of Epivir and zalcitabine (another antiviral medicine).
Erbgħa minn dawn l - istudji qabblu lil Epivir f’ kombinazzjoni ma ’ zidovudine (mediċina antivirali oħra) ma ’ jew Epivir jew zidovudine waħdu, jew il- kombinazzjoni ta ’ Epivir u zalcitabine (mediċina antivirali oħra).
The studies examined the effects of Epivir on the levels of HIV in the blood (viral load) and the number of CD4 T-cells in the blood (CD4 cell count).
L- istudji eżaminaw l- effetti ta ’ Epivir fuq il- livelli ta ’ HIV fid- demm (viral load) u l- għadd ta ’ ċelloli- T CD4 fid- demm (għadd taċ- ċelloli CD4).
CD4 T-cells are white blood cells that are important in helping to fight infections, but which are killed by HIV.
Iċ- ċelloli- T CD4 huma ċelloli tad- demm bojod li huma importanti peress li jgħinu sabiex jikumbattu l- infezzjonijiet, imma li huma maqtula minn HIV.
The fifth study compared the effects of adding Epivir or placebo (a dummy treatment) to existing treatment for HIV infection in 1,895 adults who had been taking antiviral medicines for at least four weeks.
Il- ħames studju qabbel l- effetti taż- żieda ta ’ Epivir jew plaċebo (trattament finta) ma ’ trattament eżistenti għall- infezzjoni HIV f’ 1895 adult li kienu ħadu mediċini antivirali għal ta ’ l- anqas erba ’ ġimgħat.
This study looked at how many patients developed an illness associated with AIDS or died after a year’ s treatment.
L- istudju ħares lejn kemm pazjenti żviluppaw marda assoċjata ma ’ l- AIDS jew mietu wara trattament ta ’ sena.
Epivir was also studied in 615 children.
Epivir kien studjat ukoll f’ 615- il tifel u tifla.
The study compared the effects of Epivir taken with zidovudine to didanosine (another antiviral medicine) taken alone.
L- istudju qabbel l- effetti ta ’ Epivir meħud flimkien ma ’ zidovudine ma ’ didanosine (mediċina antivirali oħra) meħud waħdu.
The study measured how long it took the children to develop an AIDS-related illness.
L- istudju kejjel kemm ħadu żmien it- tfal biex jiżviluppaw marda assoċjata ma ’ l- AIDS.
What benefit has Epivir shown during the studies?
X’ benefiċċju wera Epivir waqt l- istudji?
All of the studies found that combinations including Epivir were more effective than the comparator medicines.
L- istudji kollha sabu li kombinazzjonijiet li jinkludu Epivir kienu aktar effikaċi milli mediċini tat - tqabbil.
In the first four studies in adults, Epivir, taken in combination with zidovudine, increased CD4 cell counts more than the comparator medicines after 24 weeks of treatment.
Fl- ewwel erba ’ studji fuq adulti, Epivir, meħud flimkien ma ’ zidovudine, żied l- għadd ta ’ ċelloli aktar milli mediċini tat- tqabbil wara trattament ta ’ 24 ġimgħa.
The combination also reduced viral loads in all studies after two to four weeks of treatment, but this effect was temporary.
Il- kombinazzjoni naqqset ukoll il- viral loads fl- istudji kollha wara trattament ta ’ ġimagħtejn sa erba ’ ġimgħat, iżda dan l- effett kien wieħed temporanju.
In the fifth adult study, adding Epivir to the existing treatment reduced the risk of disease progression or death:
Fil- ħames studju fuq adulti, żieda ta ’ Epivir mat- trattament eżistenti naqqas ir - riskju ta ’ progressjoni tal- marda jew mewt:
128 (9%) of the 1,369 patients taking Epivir developed an AIDS-related illness or died, compared with 95 (20%) of the 471 patients taking placebo.
128 (9%) minn 1, 369 pazjent fuq Epivir żviluppaw marda relatata ma ’ l- AIDS jew mietu, imqabbla ma ’ 95 (20%) ta ’ 471 pazjent li kienu fuq plaċebo.
Similar results were seen in HIV- infected children.
Riżultati simili dehru fi tfal infettati bl- HIV.
What is the risk associated with Epivir?
X’ inhu r- riskju assoċjat ma ’ Epivir?
The most common side effects with Epivir (seen in between 1 and 10 patients in 100) are diarrhoea, nausea (feeling sick), vomiting, headache, insomnia (difficulty sleeping), cough, nasal symptoms, rash, muscle disorders, arthralgia (joint pain), alopecia (hair loss), fever, abdominal (tummy) pain or cramps, malaise (feeling unwell) and fatigue (tiredness).
L- aktar effetti sekondarji komuni fit- teħid ta ’ Epivir (li jidhru f’ madwar 1 u 10 pazjenti f’ 100) huma dijarrea, nawżea (dardir), remettar, uġigħ ta ’ ras, insonnja (diffikultà biex torqod), sogħla, sintomi nażali, raxx, disturbi tal- muskoli, artralġija (uġigħ fil- ġogi), alopeċja (telf ta ’ xagħar), deni, uġigħ jew brim addominali (ta ’ żaqq), tħossok ma ’ tiflaħx u għeja kbira.
For the full list of all side effects reported with Epivir, see the Package Leaflet.
Għal- lista sħiħa ta ’ l- effetti sekondarji rrapportati b’ Epivir, ara l- Fuljett ta ’ Tagħrif.
Epivir should not be used in patients with severe liver disease or who may be hypersensitive (allergic) to lamivudine or any of the other ingredients.
Epivir m’ għandux jintuża f’ pazjenti b’ mard gravi tal- fwied jew b’ ipersensittività (allerġiċi) għal lamivudine jew għal xi waħda mis- sustanzi l- oħra.
As with other anti-HIV medicines, patients taking Epivir 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 fil- każ ta ’ mediċini kontra l- HIV oħra, pazjenti li qed jieħdu Epivir jistgħu jkunu f’ riskju ta ’ lipodistrofija (tibdil fid- disribuzzjoni tax- xaħam fil- ġisem), osteonekrożi (mewt ta ’ tessut ta ’ l - għadam) jew sindromu ta ’ riattivazzjoni immunitarja (sintomi ta ’ infezzjoni kkaġunati 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 Epivir.
Pazjenti li għandhom problemi bil- fwied tagħhom (inklużi epatite B jew Ċ) jistgħu jkunu f’ riskju ogħla ta ’ ħsara għall- fwied meta jieħdu Epivir.
As with all other NRTIs, Epivir may also cause lactic acidosis (a build-up of lactic acid in the body) and, in the babies of mothers taking Epivir during pregnancy, mitochondrial dysfunction (damage to the energy-producing components within cells that can cause problems in the blood).
Bħal bl- NRTIs l- oħra kollha, Epivir jista ’ jikkaġuna aċidożi lattika (akkumulazzjoni ta ’ aċidu lattiku fil- ġisem) u, fit- trabi ta ’ ommijiet li qed jieħdu Epivir fit- tqala, disfunzjoni mitokondrijali (ħsara lill- komponenti li jipproduċu l- enerġija fiċ- ċelloli li jistgħu jikkaġunaw problemi fid- demm).
Why has Epivir been approved?
Għaliex ġie approvat Epivir?
The Committee for Medicinal Products for Human Use (CHMP) decided that Epivir’ s benefits are greater than its risks in combination with other antiretroviral medicinal products for the treatment of HIV infected adults and children.
Il- Kumitat għal Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) iddeċieda li l- benefiċċji ta ’ Epivir huma ogħla mir- riskji tiegħu f’ kombinazzjoni ma ’ prodotti mediċinali antiretrovirali oħra għat - trattament ta ’ adulti u tfal infettati bl- HIV.
The Committee recommended that Epivir be given marketing authorisation.
Il- Kumitat irrakkomanda li Epivir jingħata l - awtorizzazzjoni għat- tqegħid fis- suq.
Epivir was originally authorised under ‘ Exceptional Circumstances’, because, for scientific reasons, limited information was available at the time of approval.
Epivir ġie oriġinarjament awtorizzat taħt ‘ Ċirkostanzi Eċċezzjonali ’, minħabba li, għal raġunijiet xjentifiċi, fil- ħin ta ’ l- approvazzjoni kien hemm tagħrif limitat.
As the company had supplied the additional information requested, the ‘ Exceptional Circumstances ’ ended on 7 January 1998.
Minħabba li l- kumpanija pprovdiet it - tagħrif addizzjonali mitlub, iċ - ‘ Ċirkostanzi Eċċezzjonali ’ ntemmu fis- 7 ta ’ Jannar 1998.
Other information about Epivir:
2/ 3 Aktar tagħrif dwar Epivir:
The European Commission granted a marketing authorisation valid throughout the European Union for Epivir to Glaxo Group Limited on 8 August 1996.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fis- suq valida madwar l- Unjoni Ewropea kollha għal Epivir lil Glaxo Group Limited fit- 8 ta ’ Awwissu 1996.
The marketing authorisation was renewed on 8 August 2001 and on 8 August 2006.
L- awtorizzazzjoni għat- tqegħid fis- suq ġiet imġedda fit- 8 ta ’ Awwissu 2001 u fit- 8 ta ’ Awwissu 2006.
2/ 3 The full EPAR for Epivir can be found here.
L- EPAR sħiħ dwar Epivir jista ’ jiġi kkonsultat hawn.
Epivir 150 mg film-coated tablets
Epivir 150 mg pilloli miksija b' rita
Each film-coated tablet contains 150 mg lamivudine.
Kull pillola miksija b' rita jkun fiha 150 mg lamivudine.
For a full list of excipients, see section 6.1.
Għal lista sħiħa ta ’ sustanzi mhux attivi ara taqsima 6. 1
White, diamond shaped scored tablets engraved with “ GX CJ7” on both faces.
Pillola bajda, forma ta 'djamant b’ marka biex taqsamha minn nofs u b ’ "GX CJ7" inċiż fuq iż- żewġ naħat.
Epivir is indicated as part of antiretroviral combination therapy for the treatment of Human Immunodeficiency Virus (HIV) infected adults and children.
Epivir huwa indikat bħala parti mit- terapija antiretrovirali kombinata għall- kura ta 'adulti u tfal kontra l- Virus ta' l- Immunodefiċjenza fil- Bniedem (HIV)
The therapy should be initiated by a physician experienced in the management of HIV infection.
It- terapija għandha tinbeda minn tabib ta 'esperjenza fil- kura ta' l- infezzjoni HIV.
Epivir may be administered with or without food.
Epivir jista ’ jingħata ma ’ l- ikel jew fuq stonku vojt.
To ensure administration of the entire dose, the tablet(s) should ideally be swallowed without crushing.
Biex tassigura li d- doża tkun ittieħdet kollha, għandek idealment tibla ’ l- pillola( i) mingħajr ma tfarrakhom.
For patients who are unable to swallow tablets, lamivudine is available as an oral solution.
Għal pazjenti li ma jistgħux jibilgħu pilloli, lamivudine issibu bħala soluzzjoni orali.
Alternatively, the tablets may be crushed and added to a small amount of semi-solid food or liquid, all of which should be consumed immediately (see section 5.2).
Inkella, il- pilloli jistgħu ikunu mfarrka u miżjuda ma ’ ammont żgħir ta ’ ikel semi- solidu jew likwidu, u kollha għandhom jiġu kkunsmati minnufih (ara sezzjoni 5. 2)
Adults and adolescents (over 12 years of age): the recommended dose of Epivir is 300 mg daily.
Adulti u adolexxenti ('il fuq minn 12- il sena): id- doża rakkomandata ta' Epivir hi ta '300 mg kuljum.
This may be administered as either 150 mg twice daily or 300 mg once daily (see section 4.4).
Din tista ’ tingħata jew 150 mg darbtejn kuljum jew 300 mg darba kuljum (ara taqsima 4. 4).
The 300 mg tablet is only suitable for the once a day regimen.
Il- pillola tat- 300 mg qiegħda hemm biss għall- kura ta 'darba kuljum.
Patients changing to the once daily regimen should take 150 mg twice a day and switch to 300 mg once a day the following morning.
Pazjenti li jaqilbu għall- kura ta 'darba kuljum għandhom jieħdu 150 mg darbtejn f’ ġurnata u jaqilbu għal 300 mg darba kuljum l- għada filgħodu.
Where an evening once daily regimen is preferred, 150 mg of Epivir should be taken on the first morning only, followed by 300 mg in the evening.
Meta wieħed jippreferixxi l- kura ta 'darba kuljum filgħaxija, għandu jittieħu 150 mg Epivir fl- ewwel għodwa biss, imbagħad 300 mg filgħaxija.
When changing back to a twice daily regimen patients should complete the days treatment and start 150 mg twice a day the following morning.
Meta pazjenti jerġgħu lura għall- kura ta 'darbtejn kuljum dawn għandhom ikomplu l- kura tal- ġurnata imbagħad jibdew jieħdu 150 mg kuljum mill- għada filgħodu.
Children (under 12 years of age):
Tfal (taħt it- 12- il sena):
Since an accurate dosing can not be achieved with this formulation, dosing according to weight bands is recommended for Epivir tablets.
Billi ma tistax tintlaħaq doża eżatta b’ din il- formulazzjoni, huwa rakkomandat dożaġġ skond strixxi ta ’ piż għal pilloli ta ’ Epivir.
This dosing regimen for paediatric patients weighing 14-30 kg is based primarily on pharmacokinetic modelling, with supporting data from clinical studies.
Din is- sistema ta ’ kura għal pazjenti pedjatriċi li jiżnu minn 14- 30kg hija bbażata primarjament fuq mudell farmakokinetiku b’ data ta ’ support minn studji kliniċi.
For children weighing at least 30 kg: the adult dosage of 150 mg twice daily should be taken.
Għal tfal li jiżnu mill- anqas 30kg: għandha tittieħed id- doża ta ’ l- adulti ta ’ 150mg darbtejn kuljum.
For children weighing between 21 kg to 30 kg: the recommended oral dose of Epivir (150 mg) is one- half tablet taken in the morning and one whole tablet taken in the evening.
Għal tfal li jiżnu bejn 21kg u 30kg: id- doża orali rakkomandata ta ’ Epivir (150mg) hija ta ’ nofs pillola filgħodu u pillola sħiħa filgħaxija.
For children weighing 14 to 21 kg: the recommended oral dose of Epivir (150 mg) is one half of a scored tablet taken twice daily.
2 Għal tfal li jiżnu minn 14 sa 21kg: id- doża orali rakkomandata ta ’ Epivir (150mg) hija ta ’ nofs pillola mmarkata li tista ’ tinqasam minn nofs, darbtejn kuljum.
2 Epivir is also available as an oral solution for children over three months of age and who weigh less than 14 kg or for patients who are unable to swallow tablets.
Epivir huwa wkoll disponibbli bħala soluzzjoni li tittieħed mill- ħalq għal tfal ta ’ il- fuq minn 3 xhur li jiżnu anqas minn 14kg jew għal pazjenti li ma jistgħux jibilgħu pilloli.
Less than three months of age: the limited data available are insufficient to propose specific dosage recommendations (see section 5.2).
Għal età ta ’ anqas minn tlett xhur: l- informazzjoni limitata li hemm disponibbli ma hijiex biżżejjed biex tipproponi rakkomandazzjonijiet speċifiċi ta 'dożaġġ (ara sezzjoni 5. 2).
Lamivudine concentrations are increased in patients with moderate - severe renal impairment due to decreased clearance.
Indeboliment tal- kliewi: - Il- konċentrazzjonijiet ta ’ lamivudine jiżdiedu f' pazjenti b' indeboliment moderat jew sever tal- kliewi minħabba nuqqas ta 'tneħħija mill- ġisem.
The dose should therefore be adjusted, using oral solution presentation of Epivir for patients whose creatinine clearance falls below 30 ml/ min (see tables).
Id- doża għandha, għalhekk tinbidel, għal soluzzjoni orali ta 'Epivir f' pazjenti li t- tneħħija ta' krejatinina tagħhom tinżel għal inqas minn 30 ml/ min (ara t- tabelli).
Dosing recommendations – Adults and adolescents weighing at least 30 kg::
Rakkomandazzjonijiet dwar id- dożi - Adulti u adolexxenti li jiżnu mill- anqas 30kg:
Creatinine clearance (ml/ min)
Tneħħija ta 'krejatinina (ml/ min)
First dose
L- ewwel doża
Maintenance dose
Doża regolari
mg twice daily mg once daily
150 mg darbtejn kuljum 150 mg darba kuljum
< 30 As doses below 150 mg are needed the use of the oral solution is recommended
< 30 Billi huma meħtieġa dożi ta 'inqas minn 150 mg hu rakkomandat l- użu ta ’ soluzzjoni orali
There are no data available on the use of lamivudine in children with renal impairment.
M' hemmx informazzjoni disponibbli dwar l- użu ta ’ lamivudine fit- tfal b’ indeboliment tal- kliewi.
Based on the assumption that creatinine clearance and lamivudine clearance are correlated similarly in children as in adults it is recommended that the dosage in children with renal impairment be reduced according to their creatinine clearance by the same proportion as in adults.
Fuq is- suppożizzjoni li t- tneħħija ta 'krejatinina u t- tneħħija ta ’ lamivudine huma korrelatati l- istess fit- tfal u fl- adulti hu rakkomandat li d- dożaġġ fi tfal b' indeboliment tal- kliewi għandu jitnaqqas skond it - tneħħija krejatinina bl- istess proporzjon bħal fil- każ ta' l- adulti.
Dosing recommendations – Children aged at least 3 months and weighing less than 30 kg:
Rakkomandazzjonijiet dwar id- dożi - Tfal li għandhom mill- anqas 3 xhur u li jiżnu anqas minn 30kg:
≥ 50 30 to < 50 15 to < 30 5 to < 15 < 5
≥50 30 to < 50 15 to < 30 5 to < 15 < 5
4 mg/ kg 4 mg/ kg 4 mg/ kg 4 mg/ kg 1.3 mg/ kg
4 mg/ kg 4 mg/ kg 4 mg/ kg 4 mg/ kg 1. 3 mg/ kg
4 mg/ kg twice daily 4 mg/ kg once daily 2.6 mg/ kg once daily 1.3 mg/ kg once daily 0.7 mg/ kg once daily
4 mg/ kg darbtejn kuljum 4 mg/ kg darba kuljum 2. 6 mg/ kg darba kuljum 1. 3 mg/ kg darba kuljum 0. 7 mg/ kg darba kuljum
Data obtained in patients with moderate to severe hepatic impairment shows that lamivudine pharmacokinetics are not significantly affected by hepatic dysfunction.
Informazzjoni miksuba minn pazjenti b' indeboliment moderat jew sever tal - fwied turi li l- farmakokinetiċi ta ’ lamivudine ma jiġux affettwati b’ mod sinifikanti meta jkun hemm indeboliment tal- fwied.
Based on these data, no dose adjustment is necessary in patients with moderate or severe hepatic impairment unless accompanied by renal impairment.
Fuq il- bażi ta 'din l- informazzjoni, m' hemmx il- ħtieġa ta' tibdil ta 'doża f' pazjenti li jbatu minn indeboliment moderat jew sever tal- fwied sakemm ma jkunx hemm ukoll indeboliment tal- kliewi.
Hypersensitivity to the active substance or to any of the excipients.
Sensittivita 'eċċessiva għas- sustanza attiva jew għal xi wieħed mis- sustanzi mhux attivi.
Epivir is not recommended for use as monotherapy.
Epivir mhux rakkomandat għal użu bħala monoterapija.
In patients with moderate to severe renal impairment, the terminal plasma half-life of lamivudine is increased due to decreased clearance, therefore the dose should be adjusted (see section 4.2).
F' pazjenti b' indeboliment tal- kliewi moderat jew sever, il- half- life terminali ta ’ lamivudine fil- plażma tiżdied minħabba tnaqqis fit- tneħħija mill- ġisem, għalhekk id- doża trid tinbidel (ara taqsima 4. 2).
3 fumarate and abacavir as well as with tenofovir disoproxil fumarate and didanosine as a once daily regimen.
Kien hemm rapporti ta ’ rata għolja ta 'falliment viroloġiku u ta ’ emerġenza ta ’ reżistenza kmieni fl- istadju meta lamivudine kien ikkombinat ma ’ tenofovir disoproxil fumarate u abacavir kif ukoll ma ’ tenofovir disoproxil fumarate u didanosine b’ sistema ta ’ kura ta ’ darba kuljum.
Patients receiving Epivir or any other antiretroviral therapy may continue to develop opportunistic infections and other complications of HIV infection, and therefore should remain under close clinical observation by physicians experienced in the treatment of patients with associated HIV diseases.
Pazjenti li jkunu qed jieħdu Epivir jew xi terapija antiretrovirali oħra jistgħu ikomplu jaqbduhom infezzjonijiet opportunistiċi jew xi kumplikazzjonjiet oħra ta ’ l - infezzjonijiet ta 'l- HIV, u għalhekk għandhom jibqgħu jiġu osservati mill- qrib klinikament minn tobba ta' esperjenza fil- kura ta 'pazjenti b' mard assoċjat ma' l- HIV.
Transmission of HIV:
Tixrid ta ’ HIV:
Patients should be advised that current antiretroviral therapy, including Epivir, has not been proven to prevent the risk of transmission of HIV to others through sexual contact or contamination with blood.
Il- pazjenti għandhom jitwissew li t- terapija antiretroviralili hemm bħal issa, inkluż Epivir, ma ġietx pruvata li tneħħi r- riskju li l- HIV tittieħed minn kuntatt sesswali jew minn kontaminazzjoni bid- demm.
Appropriate precautions should continue to be taken.
Il- prekawzjonijiet meħtieġa għandhom ikomplu jittieħdu.
Cases of pancreatitis have occurred rarely.
Każijiet rari ta 'pankreatite.
However it is not clear whether these cases were due to the antiretroviral treatment or to the underlying HIV disease.
Madanakollu, mhuwiex żgur jekk dawn il- każijiet ġrawx b' riżultat tal- kura antiretrovirali jew ta 'l- istess marda ta' l- HIV.
Treatment with Epivir should be stopped immediately if clinical signs, symptoms or laboratory abnormalities suggestive of pancreatitis occur.
Il- kura b’ Epivir għandha titwaqqaf minnufih jekk jitfaċċaw xi sinjali, sintomi jew anormalitajiet kliniċi li jindikaw pankreatite.
Lactic acidosis: lactic acidosis, usually associated with hepatomegaly and hepatic steatosis, has been reported with the use of nucleoside analogues.
Aċidożi lattika: l- aċidożi lattika, li normalment hija assoċjata ma 'epatomegalija jew steatożi epatika, ġie li ġrat bl- użu ta' analogi tan- nuklejosidi.
Early symptoms (symptomatic hyperlactatemia) include benign digestive symptoms (nausea, vomiting and abdominal pain), non-specific malaise, loss of appetite, weight loss, respiratory symptoms (rapid and/ or deep breathing) or neurological symptoms (including motor weakness).
Sintomi tal- bidu (hyperlactatemia sintomatika) jinkludu sintomi beninni fid- diġestjoni (dardir, remettar u uġigħ addominali), telqa bla raġuni speċifika, nuqqas ta 'aptit, nuqqas fil- piż, sintomi respiratorji (nifs mgħaġġel u/ jew nifs qawwi) jew sintomi newroloġiċi (inkluż ċaqliq bi tbatija).
Lactic acidosis has a high mortality and may be associated with pancreatitis, liver failure, or renal failure.
L- aċidożi lattika għandha mortalita 'għolja u tista' tiġi assoċjata ma 'pankreatite, nuqqas ta' funzjoni tal- fwied, jew nuqqas ta 'funzjoni tal- kliewi.
Treatment with nucleoside analogues should be discontinued in the setting of symptomatic hyperlactatemia and metabolic/ lactic acidosis, progressive hepatomegaly, or rapidly elevating aminotransferase levels.
Il- kura bl- analogi tan- nuklejosidi għandha titwaqqaf malli jidhru hyperlactatemia sintomatika u aċidożi lattika, metabolika, epatomegalija progressiva, jew żjieda ta 'malajr fil- livelli ta' l - aminotransferase.