qanastek/EMEA-V3 huggingface dataset:
The effect of the lower dose of ADROVANCE (alendronate 70 mg/ vitamin D3 2800 IU) plus an additional 2800 IU Vitamin D3 for a total of 5600 IU (the amount of vitamin D3 in the higher dose of ADROVANCE) once weekly was demonstrated in a 24-week, extension study that enrolled 619 osteoporotic post-menopausal women.
L- effett ta ’ l- anqas doża qawwija ta ’ ADROVANCE (alendronate 70 mg/ vitamina D3 2800 IU) flimkien ma ’ 2800 IU addizzjonali ta ’ Vitamina D3 għal total ta ’ 5600 IU (l- ammont ta Vitamina D3 fid - doża l- aktar qawwija ta ’ FOSAVANCE) darba fil- ġimgħa ġie muri fi studju ta ’ estensjoni, ta ’ 24 ġimgħa, li rreġistra 619- il mara ta ’ wara l- menopawsa bl- osteoporożi.
Patients in the Vitamin D3 2800 group received ADROVANCE (70 mg/ 2800 IU) (n=299) and patients in the Vitamin D3 5600 group received ADROVANCE (70 mg/ 2800 IU) plus an additional 2800 IU vitamin D3 (n=309) once a week; additional vitamin D supplements were allowed.
Il- pazjenti fil- grupp tal - Vitamina D3 2800 irċevew ADROVANCE (70 mg/ 2800 IU) (n=299) u l- pazjenti fil- grupp tal - Vitamina D3 5600 irċevew ADROVANCE (70 mg/ 2800 IU) flimkien ma ’ 2800 IU addizzjonali ta ’ Vitamina D3 (n=309) darba fil- ġimgħa; supplimenti ta ’ vitamina D addizzjonali kienu permessi.
After 24-weeks of treatment, the mean serum 25- hydroxyvitamin D levels were significantly higher in the Vitamin D3 5600 group (69 nmol/ l [27.6 ng/ ml]) than in the Vitamin D3 2800 group (64 nmol/ l [25.5 ng/ ml]).
Wara 24 ġimgħa ta ’ kura, il- livelli medji ta ’ 25- hydroxyvitamin D fis- serum kienu sinifikattivament ogħla fil- grupp tal- Vitamina D3 5600 (69 nmol/ l [27. 6 ng/ ml]) milli fil- grupp tal- Vitamina D3 2800 (64 nmol/ l [25. 5 ng/ ml]).
The effects of alendronate on bone mass and fracture incidence in post-menopausal women were examined in two initial efficacy studies of identical design (n=994) as well as in the Fracture Intervention Trial (FIT: n=6,459).
19 L- effetti ta ’ alendronate fuq il- massa ta ’ l- għadma u l- inċidenza ta ’ fratturi f’ nisa wara l- menopawża kienu eżaminati f’ żewġ studji ta ’ l- effikaċja fil- bidu ta ’ disinn identiku (n=994) kif ukoll fil- Fracture Intervention Trial (FIT: n=6, 459).
In this study alendronate daily reduced the incidence of ≥ 1 new 18 vertebral fracture by 47% (alendronate 7.9% vs. placebo 15.0%).
F’ dan l- istudju alendronate mogħti kuljum naqqas l- inċidenza ta’ ≥1 frattura vertebrali ġdida b ’ 47% (alendronate 7. 9% kontra plaċebo 15. 0%).
2.2%, a reduction of 51%).
Barra minn hekk, tnaqqis statistikament sinifikattiv instab fl- inċidenzi ta ’ fratturi tal- għadam tal- ġenbejn (1. 1% kontra 2. 2%, tnaqqis ta ’ 51%).
The alendronate component in the ADROVANCE (70mg/ 5600 IU) combination tablet is bioequivalent to the alendronate 70 mg tablet.
Il- komponent alendronate fil- pillola kombinata ADROVANCE (70 mg/ 5600 IU) huwa bijoekwivalenti għal pillola ta ’ 70 mg alendronate.
Concentrations of alendronate in plasma following therapeutic oral doses are too low for analytical detection (< 5 ng/ ml).
Konċentrazzjonijiet ta ’ alendronate fil- plażma wara dożi terapewtiċi orali huma baxxi wisq għal
Absorption In healthy adult subjects (males and females), following administration of ADROVANCE 70 mg/ 5600 IU after an overnight fast and two hours before a meal, the mean area under the serum- concentration-time curve (AUC0-80 hrs) for vitamin D3 (unadjusted for endogenous vitamin D3 levels) was 490.2 ng• hr/ ml.
Assorbiment Wara l- għoti ta ’ ADROVANCE 70 mg/ 5600 IU f’ suġġetti adulti b’ saħħithom (irġiel u nisa) wara sawma tul il- lejl u sagħtejn qabel ikla, l- erja medja taħt il- kurva tal- konċentrazzjoni tas- serum mal- ħin (AUC0- 80 hrs) għal vitamina D3 (mhux aġġustata għal- livelli ta ’ vitamina D3 endoġena) kienet ta '490. 2 ng• hr/ ml.
The bioavailability of the 5600 IU vitamin D3 in ADROVANCE is similar to 5600 IU vitamin D3 administered alone.
Il- bijodisponibiltà tal- 5600 IU vitamina D3 f’ ADROVANCE hija simili għal 5600 IU D3 mogħtija waħedha.
EU/ 1/ 06/ 364/ 006 – 2 tablets EU/ 1/ 06/ 364/ 007 – 4 tablets EU/ 1/ 06/ 364/ 008 – 12 tablets EU/ 1/ 06/ 364/ 009 – 40 tablets
EU/ 1/ 06/ 364/ 006 – 2 pilloli EU/ 1/ 06/ 364/ 007 – 4 pilloli EU/ 1/ 06/ 364/ 008 – 12- il pillola EU/ 1/ 06/ 364/ 009 – 40 pillola
The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in version 2 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.
Id- Detentur ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- Suq jimpenja ruħu li jwettaq l- istudji u l- attivitajiet ta ’ farmakoviġilanza addizzjonali mogħtija fid- dettall fil- Pjan ta ’ Farmakoviġilanza, kif miftiehem fil - verżjoni 1 tal- Pjan tal- Ġestjoni tar- Riskju (RMP) ippreżentaat fis- Sezzjoni 1. 8. 2. ta ’ l- Applikazzjoni għall- Awtorizzazzjoni għat- Tqegħid fis- Suq u kull aġġornament sussegwenti tal- RMP miftiehem mill - CHMP.
26 PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER PACKAGING – CARTON FOR 1, 3 or 10 TRIFOLD PACK OF 2 or 4 TABLETS
PAKKETT TA 'BARRA – KARTUNA 1, 3 jew 10 GĦAL PAKKETT MILWI TLIET DARBIET TA' 2 jew 4 PILLOLI
ADROVANCE 70 mg/ 2800 IU tablets Alendronic acid as alendronate sodium trihydrate/ colecalciferol
ADROVANCE 70 mg/ 2800 IU pilloli Alendronic acid bħala alendronate sodium trihydrate/ colecalciferol
EU/ 1/ 06/ 364/ 001(2 tablets) EU/ 1/ 06/ 364/ 002 (4 tablets) EU/ 1/ 06/ 364/ 003 (6 tablets) EU/ 1/ 06/ 364/ 004 (12 tablets) EU/ 1/ 06/ 364/ 005 (40 tablets)
EU/ 1/ 06/ 364/ 001 (2 pilloli) EU/ 1/ 06/ 364/ 002 (4 pilloli) EU/ 1/ 06/ 364/ 003 (6 pilloli) EU/ 1/ 06/ 364/ 004 (12- il pillola) EU/ 1/ 06/ 364/ 005 (40 pillola)
How to take ADROVANCE tablets
Kif għandek tieħu l- pilloli ADROVANCE
2.
Ħu pillola waħda darba fil- ġimgħa 2.
When you get out of bed on the day you have chosen, and before taking your first food, drink or other medicines, swallow (do not chew or suck) one ADROVANCE tablet with a full glass of water (not mineral water).
Meta tqum mis- sodda fil- jum magħżul, u qabel ma tieħu l- ewwel ikla, xarba jew mediċina oħra, ibla '(m' għandekx tomgħod jew terda') pillola waħda ta 'ADROVANCE ma tazza mimlija bl- ilma (mhux ilma minerali).
Don ’ t lie down, eat, drink or take other medicines for at least 30 minutes.
M' għandekx la timtedd, la tiekol, la tixrob u lanqas tieħu mediċini oħra għal ta 'lanqas 30 minuta.
Remember, take ADROVANCE once each week on that same day for as long as your doctor prescribes it.
Tinsiex, ħu ADROVANCE darba fil- ġimgħa fl- istess jum għal kemm it- tabib jibqa 'jippriskrivihulek.
If you miss a dose, take only one ADROVANCE tablet on the morning after you remember.
Jekk tinsa tieħu xi doża, hu pillola waħda ta 'ADROVANCE fl- għodwa wara li tiftakar.
There is important additional information about how to take ADROVANCE in the enclosed package leaflet.
Hemm tagħrif addizzjonali importanti dwar kif għandek tieħu ADROVANCE fil- fuljett li jinsab fil - pakkett.
For your convenience, place a sticker on your calendar each week as a reminder to take your ADROVANCE.
Għal konvenjenza tiegħek, qiegħed stiker fuq il- kalendarju tiegħek biex tgħinek tiftakar biex tieħu ADROVANCE.
ADROVANCE WEEK 1 ADROVANCE WEEK 2 ADROVANCE WEEK 3 ADROVANCE WEEK 4 TIME TO REFILL
ADROVANCE ĠIMGĦA 1 ADROVANCE ĠIMGĦA 2 ADROVANCE ĠIMGĦA 3 ADROVANCE ĠIMGĦA 4 ŻMIEN BIEX TERĠA 'IĠĠIB
EU/ 1/ 06/ 364/ 001 (2 tablets) EU/ 1/ 06/ 364/ 002 (4 tablets) EU/ 1/ 06/ 364/ 003 (6 tablets) EU/ 1/ 06/ 364/ 004 (12 tablets) EU/ 1/ 06/ 364/ 005 (40 tablets)
EU/ 1/ 06/ 364/ 001 (2 pilloli) EU/ 1/ 06/ 364/ 002 (4 pilloli) EU/ 1/ 06/ 364/ 003 (6 pilloli) EU/ 1/ 06/ 364/ 004 (12- il pilloli) EU/ 1/ 06/ 364/ 005 (40 pillola)
31 PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER PACKAGING – CARTON FOR 1, 3 or 10 TRIFOLD PACK OF 2 or 4 TABLETS
32 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA PAKKETT TA ’ BARRA – KARTUNA GĦAL PAKKETT MILWI 1, 3 jew 10 DARBIET TA '2 jew 4 PILLOLI
ADROVANCE 70 mg/ 5600 IU tablets Alendronic acid as alendronate sodium trihydrate/ colecalciferol
ADROVANCE 70 mg/ 5600 IU pilloli Alendronic acid bħala alendronate sodium trihydrate/ colecalciferol
EU/ 1/ 06/ 364/ 006 (2 tablets) EU/ 1/ 06/ 364/ 007 (4 tablets) EU/ 1/ 06/ 364/ 008 (12 tablets) EU/ 1/ 06/ 364/ 009 (40 tablets)
EU/ 1/ 06/ 364/ 006 (2 pilloli) EU/ 1/ 06/ 364/ 007 (4 pilloli) EU/ 1/ 06/ 364/ 008 (12- il pillola) EU/ 1/ 06/ 364/ 009 (40 pillola)
ADROVANCE 70 mg/ 2800 IU tablets Alendronic acid as alendronate sodium trihydrate/ colecalciferol
ADROVANCE 70 mg/ 2800 IU pilloli Alendronic acid bħala alendronate sodium trihydrate / colecalciferol
ADROVANCE, before taking this medicine.
ADROVANCE, qabel tieħu din il- mediċina.
2.
X’ inhu ADROVANCE u għalxiex jintuża 2.
3.
Qabel ma tieħu ADROVANCE 3.
4.
Kif għandek tieħu ADROVANCE 4.
5 6.
Effetti sekondarji li jista ’ jkollu 5 Kif taħżen ADROVANCE 6.
WHAT ADROVANCE IS AND WHAT IT IS USED FOR
X’ INHU ADROVANCE U GĦALXIEX JINTUŻA
What is ADROVANCE?
X' inhu ADROVANCE?
ADROVANCE is a tablet containing the two active substances, alendronate sodium trihydrate and colecalciferol known as vitamin D3.
ADROVANCE huwa pillola kombinata li fiha ż- żewġ sustanzi attivi, alendronate sodium trihydrate u colecalciferol magħruf bħala vitamina D3.
What is ADROVANCE used for?
Għalxiex jintuża ADROVANCE?
Your doctor has prescribed ADROVANCE to treat your osteoporosis and because you are at risk of vitamin D insufficiency.
It- tabib tiegħek ippreskriva ADROVANCE sabiex jittratta l- osteoporożi tiegħek u minħabba li inti f' riskju minħabba nuqqas ta 'vitamina D.
ADROVANCE reduces the risk of spine and hip fractures.
ADROVANCE inaqqas ir- riskju ta 'ksur vertebrali u tal - ġenbejn.
ADROVANCE is a once weekly treatment.
ADROVANCE huwa trattament li jittieħed darba fil- ġimgħa.
At the menopause, the ovaries stop producing the female hormone, oestrogen, which helps to keep a woman ’ s skeleton healthy.
Fil - menopawsa, l- ovarji jieqfu jipproduċu l- ormon tan- nisa, l- estroġen, li jgħin iżomm l- iskeletru tan- nisu
ADROVANCE not only prevents the loss of bone but actually helps to rebuild bone you may have lost and reduces the risk of bones breaking in the spine and hip.
ADROVANCE mhux biss jimpedixxi t- telf ta 'għadam imma fil- fatt jgħin biex l- għadam li int stajt tlift jerġa' jinbena mill - ġdid u jnaqqas ir- riskju li l- għadam tas- sinsla u tal- ġenbejn jinkisser.
As well as your treatment with ADROVANCE, your doctor may suggest you make changes to your lifestyle to help your condition, such as:
Barra mit- trattament b' ADROVANCE, it- tabib tiegħek għandu mnejn jissuġerixxilek tagħmel xi tibdiliet f' ħajtek sabiex jgħin il- kondizzjoni tiegħek, bħal:
BEFORE YOU TAKE ADROVANCE
QABEL MA TIEĦU ADROVANCE
Do not take ADROVANCE (1) if you are allergic (hypersensitive) to alendronate sodium trihydrate, colecalciferol or any of the other ingredients, (2) if you have certain problems with your gullet (oesophagus - the tube that connects your mouth with your stomach) such as narrowing or difficulty swallowing, (3) if you cannot stand or sit upright for at least 30 minutes, (4) if your doctor has told you that you have low blood calcium.
Tiħux ADROVANCE (1) jekk inti allerġiku/ a (tbati minn sensittività eċċessiva) għal alendronate sodium trihydrate, colecalciferol jew xi wieħed mis- sustanzi l- oħra, (2) jekk għandek ċertu problemi f' gerżumtek (esofagu - it- tubu li jgħaqqad 'il ħalqek ma l- istonku) bħal tidjiq jew diffikultajiet biex tibla', (3) jekk ma tistax toqgħod fuq saqajk jew toqgħod bilqieghda dritt għal talanqas 30 minuta, (4) jekk it- tabib tiegħek qallek li għandek kalċju baxx fid- demm tiegħek.
Take special care with ADROVANCE It is important to tell your doctor before taking ADROVANCE • if you suffer from kidney problems, • if you have any allergies, • if you have any swallowing or digestive problems, • if you have low blood calcium levels, • if you have cancer, • if you are undergoing chemotherapy or radiotherapy, • if you are taking steroids, • if you don’ t receive routine dental care.
Oqgħod attent ħafna b' ADROVANCE Huwa importanti li tgħid lit- tabib tiegħek qabel ma tibda tieħu ADROVANCE • jekk tbati minn problemi fil- kliewi. • jekk għandek xi allerġiji. • jekk għandek xi problemi meta tibla 'jew problemi diġestivi. • jekk għandek livelli baxxi ta' kalċju fid- demm. • jekk għandek kanċer. • jekk qed ikollok kemoterapija jew radjuterapija. • jekk qed tieħu sterojdi. • jekk ma tirċiviex kura dentali ta 'spiss.
Irritation, inflammation or ulceration of the gullet (oesophagus – the tube that connects your mouth with your stomach) often with symptoms of chest pain, heartburn, or difficulty or pain upon swallowing may occur, especially if patients do not drink a full glass of water and/ or if they lie down less than 30 minutes after taking ADROVANCE.
Irritazzjoni, infjammazzjoni jew ulċerazzjoni tal- ġriżmejn (esofagu – it- tubu li jgħaqqad 'il ħalqek ma' l- istonku tiegħek) kultant b' sintomi ta 'uġigħ fis- sider, qrusa fl- istonku, jew jista' jkun hemm diffikultà jew uġigħ meta tibla ', speċjalment jekk pazjenti ma jibilgħux tazza mimlija bl- ilma u/ jew jekk jimteddu anqas minn 30 minuta wara li jieħdu ADROVANCE.
These side effects may worsen if patients continue to take ADROVANCE after developing these symptoms.
Dawn l- effetti sekondarji jistgħu jiggravaw jekk il- pazjenti jkomplu jieħdu ADROVANCE wara li jiżviluppaw dawn is- sintomi.
39 Children and adolescents ADROVANCE should not be given to children and adolescents.
40 Tfal u adoloxxenti ADROVANCE ma għandux jingħata lil tfal u adoloxxenti.
Taking other medicines It is likely that calcium supplements, antacids, and some oral medicines will interfere with the absorption of ADROVANCE if taken at the same time.
Meta tieħu mediċini oħra Jista 'jkun li supplimenti tal- kalċju, antaċidi u xi mediċini orali ser jinterferixxu ma' l- assorbiment ta 'ADROVANCE jekk jittieħdu fl- istess ħin.
HOW TO TAKE ADROVANCE.
KIF GĦANDEK TIEĦU ADROVANCE
It is likely that certain medicines or food additives may prevent the vitamin D in ADROVANCE from getting into your body, including artificial fat substitutes, mineral oils, orlistat and the cholesterol- lowering medicines, cholestyramine and colestipol.
Jista 'jkun li ċertu mediċini jew addittivi ta' l- ikel jimpedixxu l- vitamina D f' ADROVANCEmilli tidħol f' ġismek, u dawn jinkludu sostituti artifiċjali tax- xaħam, żjut minerali, orlistat u l- mediċini li jnaqqsu l - kolesterol, cholestyramine u colestipol.
Taking ADROVANCE with food and drink It is likely that food and beverages (including mineral water) will make ADROVANCE less effective if taken at the same time.
Meta tieħu ADROVANCE ma 'l- ikel u max- xorb Jista' jkun li l- ikel u x- xorb (li jinkludi l- ilma minerali) jistgħu jagħmlu 'l ADROVANCE anqas effettiv jekk jittieħed fl- istess ħin.
Pregnancy and breast-feeding ADROVANCE is only intended for use in postmenopausal women.
Tqala u Treddigħ ADROVANCE huwa maħsub biex jintuża f' nisa wara l- menopawsa.
You should not take ADROVANCE if you are or think you may be pregnant, or if you are breast-feeding.
M' għandekx tieħu ADROVANCE jekk inti, jew taħseb li inti tqila jew jekk qed tredda '.
Driving and using machines ADROVANCE should not affect your ability to drive or operate machines.
Sewqan u tħaddim ta 'magni ADROVANCE m' għandux jaffettwa l- ħila tiegħek biex issuq jew tħaddem magni.
Important information about some of the ingredients of ADROVANCE ADROVANCE contains lactose and sucrose.
Tagħrif importanti dwar xi wħud mis- sustanzi ta 'ADROVANCE ADROVANCE fih il- lactose u s- sucrose.
HOW TO TAKE ADROVANCE
KIF GĦANDEK TIEĦU ADROVANCE
Take one ADROVANCE tablet once a week.
Ħu pillola waħda ta 'ADROVANCE darba fil- ġimgħa.
Follow these instructions carefully to make sure you will benefit from ADROVANCE.
Segwi dawn l- istruzzjonijiet b' attenzjoni sabiex tagħmel żgur li int ser tibbenefika minn ADROVANCE.
Every week, take one ADROVANCE tablet on your chosen day.
Kull ġimgħa, ħu pillola waħda ta 'ADROVANCE fil- jum magħżul tiegħek.
It is very important to follow instructions 2), 3), 4) and 5) to help the ADROVANCE tablet reach your stomach quickly and help reduce the chance of irritating your gullet (oesophagus - the tube that connects your mouth with your stomach).
Huwa importanti ħafna li ssegwi l- istruzzjonijiet 2), 3), 4) u 5) sabiex tgħin il- pillola ta 'ADROVANCE tilħaq' l- istonku tiegħek malajr u sabiex jitnaqqas iċ- ċans li jiġu irritati l- griżmejn (esofagu - it- tubu li jgħaqqad 'il ħalqek ma l- istonku).
2) After getting up for the day and before taking any food, drink, or other medicine, swallow your ADROVANCE tablet with a full glass of water only (not mineral water) (not less than 200 ml or 7 fl. oz.). • Do not take with mineral water (still or sparkling). • Do not take with coffee or tea. • Do not take with juice or milk.
2) Wara li tqum għall- jum u qabel ma tieħu xi ikel, xorb, jew mediċina oħra, ibla 'il- pillola ta' ADROVANCE tiegħek b' tazza mimlija ilma (mhux ilma minerali) (mhux inqas minn 200 ml jew 7 fl. oz.). • Tiħdux ma 'l- ilma minerali (still jew li jfexfex). • Tiħdux mal- kafe jew it- te. • Tiħdux mal- meraq jew il- ħalib.
Do not chew the tablet or allow it to dissolve in your mouth.
41 M’ għandekx tomgħod il- pillola jew tħalliha tinħall f' ħalqek.
40 3) Do not lie down — stay fully upright (sitting, standing or walking) — for at least 30 minutes after swallowing the tablet.
3) M' għandekx timtedd — żomm ruħek wieqaf (bilqieghda, bilwieqfa jew imxi) — għal ta 'lanqas 30 minuta wara li tibla' il- pillola.
4) Do not take ADROVANCE at bedtime or before getting up for the day.
4) M' għandekx tieħu ADROVANCE fil- ħin ta 'qabel l- irqadt jew qabel ma' tqum għall- jum.
5) If you develop difficulty or pain upon swallowing, chest pain, or new or worsening heartburn, stop taking ADROVANCE and contact your doctor.
5) Jekk tiżviluppa diffikutà jew uġigħ meta tibla ', uġigħ f' sidrek, jew qrusa fl- istonku ġdida jew li taġġrava, tibqax tieħu ADROVANCE u kkuntattja lit- tabib tiegħek.
6) After swallowing your ADROVANCE tablet, wait at least 30 minutes before taking your first food, drink, or other medicine of the day, including antacids, calcium supplements and vitamins.
6) Wara li tibla 'l- pillola ta' ADROVANCE tiegħek, stenna għal ta 'lanqas 30 minuta qabel ma tieħu l- ewwel ikla, xarba jew mediċina tiegħek tal- jum, li jistgħu jinkludu antaċidi, supplimenti tal- kalċju u vitamini.
ADROVANCE is effective only if taken when your stomach is empty.
ADROVANCE hu effettiv biss meta l- istonku tiegħek ikun vojt.
If you take more ADROVANCE than you should If you take too many tablets by mistake, drink a full glass of milk and contact your doctor immediately.
Jekk tieħu ADROVANCE aktar milli suppost Jekk tieħu ħafna pilloli bi żball, ixrob tazza mimlija ħalib u kkuntattja lit- tabib tiegħek minnufih.
If you forget to take ADROVANCE If you miss a dose, just take one tablet on the morning after you remember.
Jekk tinsa tieħu ADROVANCE Jekk tinsa tieħu xi doża, hu pillola waħda ta 'ADROVANCE fl- għodwa ta' wara li tiftakar.
If you stop taking ADROVANCE It is important that you continue taking ADROVANCE for as long as your doctor prescribes the medicine.
Jekk tieqaf tieħu ADROVANCE Huwa importanti li tkompli tieħu ADROVANCE għal kemm idum jippreskrivih it- tabib tiegħek.
ADROVANCE can treat your osteoporosis only if you continue to take the tablets.
ADROVANCE jista 'biss jittratta l- osteoporożi tiegħek jekk tibqa' tieħu l- pilloli.
Like all medicines, ADROVANCE can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, ADROVANCE jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
HOW TO STORE ADROVANCE
KIF TAĦŻEN ADROVANCE
Do not use ADROVANCE after the expiry date which is stated on the carton and the wallet after EXP.
Tużax ADROVANCE wara d- data ta ’ skadenza li tidher fuq il- kartuna u l- kartiera wara JIS.
What ADROVANCE contains
X' fih ADROVANCE
42 What ADROVANCE looks like and contents of the pack
Id- dehra ta 'ADROVANCE u l- kontenuti tal- pakkett
ADROVANCE 70 mg/ 2800 IU tablets are available as capsule-shaped, white to off-white tablets marked with an outline of a bone image on one side and ‘ 710 ’ on the other.
ADROVANCE pilloli tas 70mg/ 2800 IU jiġu bħala pilloli f' għamla ta 'kapsuli, ta' lewn bajdani jew bojod jagħtu fil- griż immarkati b 'kontorn ta' immaġni ta 'għadma fuq naħa u' 710 'fuq in- naħa l- oħra.
Deutschland MSD SHARP & DOHME GMBH Tel: +49 (0) 89 4561 2612 Infocenter@msd. de
Deutschland MERCK SHARP & DOHME GMBH Tel: +49 (0) 89 4561 2612 Infocenter@ msd. de
Ι talia Addenda Pharma S. r. l., Tel: +39-06-9139 3303 info@addenda. it
Tel: +39- 06- 91393303 info@ addenda. it
Latvija SIA “ Merck Sharp & Dohme Latvija” Tel: +371 67364 224 msd_lv@merck. com
45 Latvija SIA "Merck Sharp & Dohme Latvija" Tel: +371. 67364. 224 msd_ lv@ merck. com
Lietuva UAB “ Merck Sharp & Dohme” Tel.: +370 5 278 02 47 msd_lietuva@merck. com
Lietuva UAB "Merck Sharp & Dohme" Tel: +370 5 278 02 47 msd_ lietuva@ merck. com
It may harm them, even if
Tista ’ tagħmlilhom il -
their symptoms are the same as yours.
ħsara, anki jekk ikollhom l- istess sintomi bħal tiegħek.
45 Early on, osteoporosis usually has no symptoms.
Fl- istadju bikri, l- osteoporożi ġeneralment ma jkollhiex sintomi.
Children and adolescents ADROVANCE should not be given to children and adolescents.
48 Tfal u adoloxxenti ADROVANCE ma għandux jingħata lil tfal u adoloxxenti.
46 Taking other medicines It is likely that calcium supplements, antacids, and some oral medicines will interfere with the absorption of ADROVANCE if taken at the same time.
Meta tieħu mediċini oħra Jista 'jkun li supplimenti tal- kalċju, antaċidi u xi mediċini orali ser jinterferixxu ma' l- assorbiment ta 'ADROVANCE jekk jittieħdu fl- istess ħin.
Medicines for fits (seizures) may decrease the effectiveness of vitamin D.
Mediċini għall - aċċessjonijiet (attakki ta 'puplesija) jistgħu jnaqqsu l- effettività ta' vitamina D.
It is very important to follow instructions 2), 3), 4) and 5) to help the ADROVANCE tablet reach your stomach quickly and help reduce the chance of irritating your gullet (oesophagus - the tube that connects your mouth with your stomach).
Huwa importanti ħafna li ssegwi l- istruzzjonijiet 2), 3), 4) u 5) sabiex tgħin il- pillola ta 'ADROVANCE tilħaq' l- istonku tiegħek malajr u sabiex jitnaqqas iċ- ċans li jiġu irritati l - griżmejn (esofagu - it- tubu li jgħaqqad 'il ħalqek ma l- istonku).
Do not chew the tablet or allow it to dissolve in your mouth.
49 M’ għandekx tomgħod il- pillola jew tħalliha tinħall f' ħalqek.
3) Do not lie down — stay fully upright (sitting, standing or walking) — for at least 30 minutes after swallowing the tablet.
3) M' għandekx timtedd — żomm ruħek wieqaf (bilqieghda, bilwieqfa jew imxi) — għal ta 'lanqas 30 minuta wara li tibla' il- pillola.
47 5) If you develop difficulty or pain upon swallowing, chest pain, or new or worsening heartburn, stop taking ADROVANCE and contact your doctor.
5) Jekk tiżviluppa diffikutà jew uġigħ meta tibla ', uġigħ f' sidrek, jew qrusa fl- istonku ġdida jew li taġġrava, tibqax tieħu ADROVANCE u kkuntattja lit- tabib tiegħek.
48 • rash made worse by sunlight, • severe bone, muscle and/ or joint pain, • mouth ulcers when the tablets have been chewed or sucked, • transient flu-like symptoms, such as aching muscles, generally feeling unwell and sometimes with fever usually at the start of treatment.
50 Rari: • reazzjonijiet allerġiċi bħal ħorriqija, nefħa tal- wiċċ, xofftejn, ilsien u/ jew gerżuma, li jistgħu jikkawżaw diffikultà fit- teħid tan- nifs jew biex tibla ’, • sintomi ta ’ livelli baxxi ta ’ kalċju fid- demm li jinkludu bugħawwiġijiet fil- muskoli u/ jew sensazzjoni ta ’ tnemnim fis- swaba ’ u madwar il- ħalq, • ulċeri fl- istonku jew peptiċi (xi kultant serji jew bil- fsada), • tidjiq tal- griżmejn (esofagu – it- tubu li jgħaqqad lil ħalqek ma 'l- istonku), • vista mċajpra, uġigħ jew ħmura fl- għajnejn, • raxx li jiggrava bid- dawl tax- xemx, • uġigħ sever fl- għadam, fil- muskoli u/ jew fil- ġogi, • ulċeri fil- ħalq wara li l- pilloli jingidmu jew jiġu msoffija, • sintomi temporanji bħal ta ’ l- influwenza, bħal uġigħ fil- muskoli, ġeneralment tħossok mhux f' siktek u kultant bid- deni normalment fil- bidu tat- trattament.
The other ingredients are microcrystalline cellulose (E460), lactose anhydrous, medium chain triglycerides, gelatin, croscarmellose sodium, sucrose, colloidal silicon dioxide, magnesium stearate (E572) butyl hydroxytoluene (E321), modified starch (maize), and sodium aluminium silicate (E554).
51 Is- sustanzi l- oħra huma microcrystalline cellulose (E460), lactose anhydrous, medium chain triglycerides, gelatin, croscarmellose sodium, sucrose, colloidal silicon dioxide, magnesium stearate (E572), butyl hydroxytoluene (E321), modified starch (maize), u sodium aluminium silicate (E554).
What ADROVANCE looks like and contents of the pack
Id- dehra ta 'ADROVANCE u l- kontenuti tal- pakkett
ADROVANCE 70 mg/ 5600 IU tablets are available as modified rectangle-shaped, white to off-white tablets marked with an outline of a bone image on one side and ‘ 270’ on the other.
ADROVANCE pilloli tas- 70 mg/ 5600 IU jiġu bħala pilloli f' għamla ta 'kapsuli rettangolari modifikati, ta' lewn bajdani jew bojod jagħtu fil- griż immarkati b 'kontorn ta' immaġni ta 'għadma fuq naħa u' 270 'fuq in- naħa l- oħra.
49 The tablets are supplied in wallets with sealed aluminium blisters in cartons in the following pack sizes
Il- pilloli jiġu f' kartieri f' folji ta 'l- aluminju ssiġillati f' kartun fid- daqsijiet tal- pakketti li ġejjin
Latvija SIA “ Merck Sharp & Dohme Latvija” Tel: +371 67364 224 msd_lv@merck. com
53 Latvija SIA “ Merck Sharp & Dohme Latvija ” Tel: +371 67364 224 msd_ lv@ merck. com
This document is a summary of the European Public Assessment Report (EPAR).
Dan id- dokument huwa sommarju tar- Rapport ta 'Valutazzjoni Pubblika Ewropea (EPAR).
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 inti 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 Advagraf?
X' inhu Advagraf?
Advagraf is a medicine containing the active substance tacrolimus.
Advagraf hu mediċina li fiha s- sustanza attiva tacrolimus.
It is available as prolonged- released capsules containing tacrolimus (0.5 mg: yellow and orange; 1 mg: white and orange; 5 mg: greyish-red and orange). ‘ Prolonged-release ’ means that tacrolimus is released slowly from the capsule over a few hours.
'Jerħu l- mediċina bil- mod' tfisser li tacrolimus jiġi rilaxxat bil- mod mill- kapsula fi ftit sigħat.
What is Advagraf used for?
Għal xiex jintuża Advagraf?
Advagraf is used in adult patients who have had a kidney or liver transplant, to prevent rejection (when the immune system attacks the transplanted organ).
Advagraf jintuża f' pazjenti adulti li kellhom trapjant tal- kilwa jew tal- fwied biex ikun evitat rifjut (rejection) (meta s- sistema immunitarja tattakka l- organu trapjantat).
Advagraf can also be used to treat organ rejection in adult patients when other immunosuppressive medicines are not effective.
Advagraf jista 'jintuża wkoll biex jittratta r- rifjut ta' l- organi f' pazjenti adulti meta mediċini immunosoppressivi oħra ma jkunux effikaċi.
The medicine can only be obtained with a prescription.
Il- mediċina tinkiseb biss b' riċetta ta 'tabib.
How is Advagraf used?
Kif jintuża Advagraf?
Treatment with Advagraf should only be prescribed by doctors who have experience in the management of transplant patients.
It- trattament b' Advagraf għandu jiġi preskritt biss minn tobba li jkollhom esperjenza fil- ġestjoni ta 'pazjenti trapjantati.
Advagraf is for long-term use.
Advagraf hu għal użu fit- tul.
Doses are calculated based on the patient’ s weight.
Id- dożi huma kkalkulati skond il- piż tal- pazjent.
Doctors should monitor the levels of tacrolimus in the blood to check that they stay within predefined ranges.
It- tobba għandhom jissorveljaw il- livelli ta 'tacrolimus fid- demm biex jivverifikaw li għadhom fil- livelli predefiniti.
In the prevention of rejection, the dose of Advagraf to use depends on the type of transplant the patient has received.
Bil- għan li jiġi evitat ir- rifjut, id- doża ta 'Advagraf li għandha tintuża tiddependi mit- tip ta' trapjant li jkun irċieva l- pazjent.
In kidney transplant, the starting dose is 0.20 to 0.30 mg per kilogram body weight.
Fil- każ ta 'trapjant tal- kliewi, id- doża tal- bidu hi 0. 20 sa 0. 30 mg għal kull kilogramma li jiżen il- pazjent.
In liver transplant, the starting dose is 0.10 to 0.20 mg/ kg.
Fil- każ ta 'trapjant tal- fwied, id- doża tal- bidu hi 0. 10 sa 0. 20 mg/ kg.
When treating rejection, these same doses may be used in kidney and liver transplants.
Fit- trattament tar- rifjut, dawn l- istess dożi jistgħu jintużaw għat- trapjanti tal- kliewi u tal- fwied.
Starting doses are 0.10 to 0.30 mg/ kg in other types of transplant (heart, lung, pancreas or intestine).
Id- dożi tal- bidu f' tipi oħra ta 'trapjanti (tal- qalb, tal- pulmun, tal- frixa (pankreas), tal- musrana (intestin) huma bejn 0. 10 u 0. 30 mg/ kg.
Advagraf is given once a day, in the morning, at least one hour before or two to three hours after food.
Advograf jingħata darba kuljum, filgħodu, ta 'l- inqas siegħa qabel jew bejn sagħtejn u tliet sigħat wara l- ikel.
How does Advagraf work?
Kif jaħdem Advagraf?
Tacrolimus, the active substance in Advagraf, is an immunosuppressive agent.
Tacrolimus, is- sustanza attiva f' Advagraf, hu aġent immunosoppressiv.
This means that it reduces the activity of the immune system (the body ’ s natural defences).
Dan ifisser li jnaqqas l- attività tas- sistema immunitarja (id- difiża naturali tal- ġisem).
Tacrolimus acts on some special cells in the immune system called T-cells that are primarily responsible for attacking the transplanted organ (organ rejection).
Tacrolimus jaħdem fuq ċelluli speċjali tas - sistema immunitarja magħrufa bħala ċelloli- T li x- xogħol ewlieni tagħhom hu li jattakkaw l- organu li jkun ġie trapjantat (ir- rifjut ta 'l- organi).
Tacrolimus has been used since the mid-1990’ s.
Tacrolimus ilu jintuża minn nofs is- snin disgħin.
In the European Union (EU), it has been available as capsules under the name Prograf or Prograft (depending on the country).
Fl- Unjoni Ewropea (UE), kien jiġi bħala kapsuli jisimhom Prograf jew Prograft (l- isem ivarja skond il- pajjiż).
Reproduction is authorised provided the source is acknowledged. released more slowly from the capsule than it is in Prograf/ Prograft.
Reproduction is authorised provided the source is acknowledged. bil- mod mill- kapsula milli jseħħ bi Prograf/ Prograft.
This allows Advagraf to be given once a day, whereas Prograf/ Prograft is given twice a day.
B' hekk Advagraf ikun jista 'jingħata darba kuljum, waqt li Prograf/ Prograft jingħata darbtejn kuljum.
This can help the patients stick to their treatment.
Dan jista 'jgħin lill- pazjenti jżommu mat - trattament tagħhom.
How has Advagraf been studied?
Kif ġie studjat Advagraf?
Because tacrolimus and Prograf/ Prograft have already been used in the EU, the company presented the results of studies that had been carried out with Prograf/ Prograft previously, as well as data from the published literature.
Billi tacrolimus u Prograf/ Prograft kienu diġà jintużaw fl- UE, il- kumpanija ppreżentat ir- riżultati ta 'studji li kienu saru qabel bi Prograf/ Prograft, kif ukoll dejta minn xi studji ppubblikati.
It also presented the results of a clinical study in 668 kidney transplant patients comparing the use of Advagraf with that of Prograf/ Prograft or ciclosporin (another immunosuppressive medicine used in the prevention of rejection).
Ippreżentat ukoll ir- riżultati ta 'studju kliniku f' 668 pazjent li kienu rċevew trapjant tal- kliewi li qabbel l- użu ta' Advagraf ma 'dak ta' Prograf/ Prograft jew iċ- ċiklosporina (mediċina immunosoppressiva oħra użata fil- prevenzjoni tar- rifjut).
Patients also received mycophenolate mofetil (another medicine used in the prevention of rejection).
Il- pazjenti rċevew ukoll mikofenolat mofetil (mycophenolate mofetil) (mediċina oħra użata fil- prevenzjoni tar- rifjut).
The main measure of effectiveness was the number of patients in whom the transplant failed (as measured by looking at, for example, the need for a repeat transplant or a return to dialysis) after one year’ s treatment.
Il- kejl ewlieni ta 'l- effikaċja kien in- numru ta' pazjenti li fihom ma ħadimx it- trapjant (kif imkejjel, per eżempju, bil- ħtieġa ta 'trapjant ieħor jew ta' ħtieġa mill- ġdid tad- dijaliżi) wara sena trattament.
Further shorter studies were also carried out in 119 kidney transplant patients and 129 liver transplant patients, looking at how Advagraf is absorbed by the body in comparison to Prograf/ Prograft.
Saru xi studji qosra oħra f' 119- il pazjent li rċevew trapjant tal- kliewi u f' 129 pazjent li rċevew trapjant tal- fwied, b' analiżi ta 'kif Advagraf ġie assorbit fil- ġisem meta mqabbel ma' Prograf/ Prograft.
What benefit has Advagraf shown during the studies?
X' inhuma l- benefiċċji ta 'Advagraf li ntwerew f' dawn l- istudji?
Advagraf was as effective as both comparator medicines.
Advagraf kien effikaċi daqs iż- żewġ mediċini li tqabbel magħhom.
After one year, 14% of the patients receiving Advagraf had experienced organ failure.
Wara sena, 14% tal- pazjenti li kienu qed jieħdu Advagraf esperjenzaw falliment ta 'xi organu.
The percentages were 15% in the patients treated with Prograf/ Prograft, and 17% in those treated with ciclosporin.
Il- perċentwali kienu ta '15% fil - pazjenti trattati bi Prograf/ Prograft, u 17% ta' dawk trattati biċ- ċiklosporina.
The shorter studies in kidney and liver transplant patients showed that Advagraf and Prograf/ Prograft have comparable absorption in the body.
L- istudji iqsar dwar pazjenti li rċevew trapjant tal- kliewi u tal- fwied urew li Advgraf u Prograf/ Prograft għandhom assorbiment paragunabbli fil- ġisem.
What is the risk associated with Advagraf?
X' riskju hu assoċjat ma 'l- użu ta' Advagraf?
The most common side effects with Advagraf (seen in more than 1 patient in 10) are tremor (shaking), headache, nausea (feeling sick), diarrhoea, kidney problems, hyperglycaemia (raised blood glucose levels), diabetes, hyperkalaemia (raised blood potassium levels), hypertension (high blood pressure) and insomnia (difficulty sleeping).
L- iktar effetti sekondarji komuni b' Advagraf (li dehru f' iktar minn pazjent wieħed minn kull 10) huma rogħda, uġigħ ta 'ras, nawżea (dardir), dijarrea, problemi bil- kliewi, ipergliċemija (livell għoli ta' glukożju fid- demm), dijabete, iperkaljemija (livell għoli ta 'potassju fid- demm), ipertensjoni (pressjoni tad- demm għolja) u insonnja (tbatija fl- irqad).
For the full list of all side effects reported with Advagraf, see the Package Leaflet.
Għal- lista sħiħa ta 'l- effetti sekondarji li ġew rapportati ma' l- użu ta 'Advagraf, ara l- Fuljett ta' Tagħrif.
Advagraf should not be used in people who may be hypersensitive (allergic) to tacrolimus, to macrolide antibiotics (such as erythromycin) or to any of the other ingredients.
Advagraf m' għandux jintuża f' persuni li huma ipersensittivi (allerġiċi) għal tacrolimus, għal antibijotiċi makrolidi (bħal eritromiċina [erythromycin]) jew għal sustanzi oħra.
Patients and doctors must be careful when other medicines (including some herbal remedies) are taken at the same time as Advagraf, as there may be a need to adjust the dose of Advagraf or the dose of the medicine it is taken with.
Il- pazjenti u t- tobba għandhom joqogħdu attenti meta jkunu qed jittieħdu mediċini oħra (inkluż xi rimedji tal- ħxejjex aromatiċi) fl- istess ħin, għax jista 'jkun hemm bżonn ta' aġġustament fid- doża ta 'Advagraf jew fid- doża tal- mediċina li tkun qed tittieħed fl- istess ħin.
See the Package Leaflet for details.
Ara l- Fuljett ta 'Tagħrif għal iktar dettalji.
Why has Advagraf been approved?
Għaliex ġie approvat Advagraf?
The Committee for Medicinal Products for Human Use (CHMP) decided that Advagraf’ s benefits are greater than its risks for the prophylaxis of transplant rejection in adult kidney and liver allograft recipients, and in the treatment of allograft rejection resistant to treatment with other immunosuppressive medicinal products in adult patients.
Il- Kumitat għal Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) iddeċieda li l- benefiċċji ta 'Advagraf huma ikbar mir- riskji fil- profilassi tar- rifjut tat- trapjant fil- pazjenti adulti li rċevew trapjant alloġeniku (allograft recipients) ta' kilwa jew tal- fwied, u fit- trattament tar- rifjut alloġeniku reżistenti għat- terapija b' mediċini immunosoppressivi oħra fil- pazjenti adulti.
The Committee recommended that Advagraf be given marketing authorisation.
Il- Kumitat irrakkomanda li Advagraf jingħata awtorizzazzjoni għat- tqegħid fis- suq.
Other information about Advagraf:
Aktar tagħrif dwar Advagraf:
The European Commission granted a marketing authorisation valid throughout the EU for Advagraf on 23 April 2007.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fis- suq valida fl- UE kollha għal Advagraf fit- 23 ta 'April 2007.
The marketing authorisation holder is Astellas Pharma Europe B. V.
Id- detentur ta 'l- awtorizzazzjoni għat- tqegħid fis- suq huwa Astellas Pharma Europe B. V.
The full EPAR for Advagraf can be found here.
L- EPAR sħiħ dwar Advagraf huwa disponibbli minn hawn.
EU/ 1/ 07/ 387/ 001
Numru ta ’ l- EU EU/ 1/ 07/ 387/ 001
Advagraf
Isem inventat Advagraf
0.5 mg
Qawwa 0. 5mg
Prolonged release hard capsules
Għamla farmaċewtika Kapsuli li jerћu l- mediċina bilmod, iebsa
Oral use
Mnejn jingħata Użu għal ћalq
blister (PVC/ PVDC/ alu)
Il- pakkett Folja (PVC/ PVDC/ alu)
30 capsules
Daqs tal- pakkett 30 Kapsula
0.5 mg
0. 5mg
Prolonged release hard capsules
Kapsuli li jerћu l- mediċina bilmod, iebsa
Oral use
Użu għal ћalq
blister (PVC/ PVDC/ alu)
Folja (PVC/ PVDC/ alu)
50 capsules
50 Kapsula
30 capsules
30 Kapsula
60 capsules
60 Kapsula
100 capsules
100 Kapsula
Advagraf 0.5 mg Prolonged-release hard capsules
Advagraf 0. 5 mg Kapsuli iebsin li jerћu l- mediċina bil- mod
Each prolonged-release capsule contains 0.5 mg of tacrolimus.
Kull kapsula li terћi l- mediċina bil- mod fiha 0. 5 mg ta ’ tacrolimus.
Each prolonged-release capsule contains 53.64 mg of lactose monohydrate
Kull kapsula li terћi l- mediċina bil- mod fiha 53. 64 mg ta ’ lactose monohydrate
For a full list of excipients, see section 6.1.
Għal- lista kompleta ta 'sustanzi mhux attivi, ara sezzjoni 6. 1.
Prolonged-release hard capsules.
Kapsuli ebsin li jerћu l- mediċina bil- mod.
Yellow-orange gelatin capsules imprinted in red with “ 0.5 mg” on the light yellow capsule cap and “ 647” on the orange capsule body, containing white powder.
Kapsuli tal- ġelatina, ta ’ lewn isfar aranġjo b ’ “ 0. 5 mg ” miktuba bl- aħmar fuq l- għatu isfar ċar tal - kapsula u b ’ “  647 ” fuq l- għatu aranġjo tal- kapsula, mimlija trab abjad.
Prophylaxis of transplant rejection in adult kidney or liver allograft recipients.
Il- profilassi tar- riġezzjoni ta ’ trapjant fl- adulti li jirċievu allograft ta ’ kilwa jew fwied.
Treatment of allograft rejection resistant to treatment with other immunosuppressive medicinal products in adult patients.
Il- kura għar- riġezzjoni tal- allograft li tkun reżistenti għall - kura bi prodotti mediċinali immunosuppressivi oħra f’ pazjenti adulti.
Advagraf is a once-a-day oral formulation of tacrolimus.
Advagraf, huwa formulazzjoni ta ’ tacrolimus, li jittieħed mill- ħalq darba biss kuljum.
Advagraf therapy requires careful monitoring by adequately qualified and equipped personnel.
Il- kura b’ Advagraf tinħtieġ tkun iċcekkjata b’ attenzjoni minn min ikun kwalifikat u preparat biżżejjed.
The medicinal product should only be prescribed, and changes in immunosuppressive therapy initiated, by physicians experienced in immunosuppressive therapy and the management of transplant patients.
Dan il- prodott mediċinali għandu biss jingħata, u l- bidliet fit- terapija immunosuppressiva jinbdew, minn tobba ta ’ esperjenza fit- terapija immunosuppressiva u fl- immaniġgar ta ’ pazjenti li kellhom trapjant
Inadvertent, unintentional or unsupervised switching of immediate- or prolonged-release formulations of tacrolimus is unsafe.
Tibdil b’ nuqqas ta ’ attenzjoni, bla intenzjoni jew mhux taћt osservazzjoni ta ’ formulazzjonijiet ta ’ tacrolimus jigifieri bejn dik b’ rilaxx immedjat u dik b’ rilaxx prolungat jista ’ jkun ta ’ ћsara.
This can lead to graft rejection or increased incidence of side effects, including under- or overimmunosuppression, due to clinically relevant differences in systemic exposure to tacrolimus.
Dan jista ’ jwassal gћal rifjut tal- graft jew gћal żieda fl- inċidenza tal- effetti mhux mixtieqa, inklużi nuqqas jew żieda fl- immunosuppressjoni, minћabba tibdil klinikament relevanti fl- espożizzjoni sistemika gћal tacrolimus.
Patients should be maintained on a single formulation of tacrolimus with the corresponding daily dosing regimen; alterations in formulation or regimen should only take place under the close supervision of a transplant specialist (see sections 4.4 and 4.8).
Pazjenti gћandhom jinżammu fuq formulazzjoni waћda ta ’ tacrolimus bid- doża xierqa ta ’ kuljum; tibdil fil- formulazzjoni jew fid- dożaġġ iridu iseћћu biss taћt superviżjoni mill- qrib tal - ispeċjalista tat- trapjanti (ara sezzjoni 4. 4 u 4. 8).
Following conversion to any alternative formulation, therapeutic drug monitoring must be performed and dose adjustments made to ensure that systemic exposure to tacrolimus is maintained.
Wara li jsir tibdil gћal formulazzjoni alternattiva, irid isir moniteraġġ terapewtiku tal- mediċina u d- doża trid tiġi rranġata b’ mod li tkun ċert li l- espożizzjoni sistemika gћal tacrolimus qed tinżamm.
General considerations The recommended initial doses presented below are intended to act solely as a guideline.
Punti ġenerali li wieħed għandu jikkonsidra Id- dożi rikkmandati fil- bidu li jidhru hawn taħt maħsuba biex iservu biss ta ’ linja gwida.
Advagraf is routinely administered in conjunction with other immunosuppressive agents in the initial post- operative period.
Fl- ewwel żmien wara l- operazzjoni Advagraf jingħata regolari flimkien ma ’ aġenti oħra immuno- suppressiva.
The dose may vary depending upon the immunosuppressive regimen chosen.
Id- doża tista ’ tvarja skond ir- reġimen immunosuppressiv magħżul.
Advagraf dosing should primarily be based on clinical assessments of rejection and tolerability in each patient individually aided by blood level monitoring (see below under “ Target whole blood trough concentration recommendations”).
Id- doża ta ’ Advagraf trid tkun l - ewwelnett mibnija fuq stimi kliniċi ta ’ kemm hu tollerabbli jew rifjutat individwalment f’ kull pazjent, megħjun bil- monitoraġġ tal- livelli tad- demm (ara taħt “ Rakkomandazzjonijiet dwar x’ livelli ‘ trough ’ ta ’ konċentrazzjoni għandu jilħaq fid- demm sħiħ ”) Jekk jdhru xi sinjali kliniċi ta ’ riġezzjoni, għandha tintqies bidla fir- reġimen immunosuppressiv.
In stable patients converted from Prograf (twice daily) to Advagraf (once daily) on a 1:1 (mg: mg) total daily dose basis the systemic exposure to tacrolimus (AUC0-24) for Advagraf was approximately 10% lower than that for Prograf.
2 F’ pazjenti stabbli li qalbu minn Prograf (darbtejn kuljum) għal Advagraf (darba kuljum) fuq bażi ta ’ doża totali kuljum ta ’ 1: 1 (mg: mg), l- esponiment sistemiku għal tacrolimus (AUC0- 24) fl- Advagraf kien bejn wieħed u ieħor 10% inqas minn dak ta ’ Prograf.
The relationship between tacrolimus trough levels (C24) and systemic
Ir- relazzjoni bejn il- livelli ‘ trough ’ ta ’ tacrolimus (C24) u l - espożizzjoni sistemika (AUC0- 24) għal Advagraf tixbaћ ħafna lil dik ta ’ Prograf.
When converting from Prograf capsules to Advagraf tacrolimus trough levels should be measured prior to conversion and within two weeks after conversion.
Qabel ma ssir il- bidla mill- kapsuli Prograf għal Advagraf għandhom jitkejlu il- livelli ‘ trough ’ ta ’ tacrolimus u fi żmien ġimagħtejn wara li tkun saret il- qalba.
Dose adjustments should be made to ensure that similar systemic exposure is maintained.
Għandhom isiru l - aġġustamenti fid- doża biex wieħed ikun żgur li tinżamm l- istess espożizzjoni sistemika.
In de novo kidney and liver transplant patients AUC0-24 of tacrolimus for Advagraf on Day 1 was 30% and 50% lower respectively, when compared with that for Prograf at equivalent doses.
F’ pazjenti de novo bi trapjant tal- kliewi u tal- fwied l- AUC0- 24 ta ’ tacrolimus għal Advagraf fl- Ewwel Jum kien 30% u 50% inqas rispettivament, meta mqabbel ma ’ dożi eqwivalenti għal dak ta ’ Prograf.
By Day 4, systemic exposure as measured by trough levels is similar for both kidney and liver transplant patients with both formulations.
Mar- raba ’ jum l- espożizzjoni sistemika kif imkejla mal- livelli ‘ trough ’ hi simili kemm għall - pazjenti li għamlu trapjant tal- kliewi kif ukoll għal dawk li kellhom trapjant tal- fwied biż - żewġ formulazzjonijiet.
Careful and frequent monitoring of tacrolimus trough levels is recommended in the first two weeks post-transplant with Advagraf to ensure adequate drug exposure in the immediate post-transplant period.
Fl- ewwel ġimagħtejn ta ’ wara t- trapjant bl- Advagraf jeħtieġ li jsir, sikwit u b’ ċerta attenzjoni, monitoraġġ tal- livelli ‘ trough ’ ta ’ tacrolimus rikkkmandati biex wieħed ikun żgur li qed tingħata biżżejjed mill- mediċina immedjatament wara ż- żmien li jkun sar it- trapjant.
As tacrolimus is a substance with low clearance, adjustments to the Advagraf dose regimen may take several days before steady state is achieved.
Billi tacrolimus hu sustanza li titneħħa bil- mod, l- aġġustamenti tad- doża ta ’ Advagraf jistgħu jieħdu diversi ġranet qabel ma wieħed jasal tabilħaqq għad- doza fissa.
In patients unable to take oral medicinal products during the immediate post-transplant period, tacrolimus therapy can be initiated intravenously (Prograf 5 mg/ ml Concentrate for Infusion) at a dose approximately 1/ 5th of the recommended oral dose for that indication.
F’ pazjenti li, filpront wara ż- żmien tat- trapjant, ma jkunux jistgħu jieħdu prodotti mediċinali minn ħalqhom, tista ’ tinbdielhom il- kura b’ tacrolimus mill- vina (Prograf 5mg/ ml Konċentrat għall - infużjoni) f’ doża ta ’ bejn wieħed u ieħor 1/ 5 (wieħed minn ħamsa) tad- doża rikkmandata biex tingħata mill- ħalq għal dik l- indikazzjoni.
Method of administration It is recommended that the oral daily dose of Advagraf be administered once daily in the morning.
Mod kif jittieħed Huwa rrikkmandat li d- doża mill- ħalq ta ’ kuljum ta ’ Advagraf tingħata darba kuljum filgħodu.
Advagraf prolonged-release capsules should be taken immediately following removal from the blister.
Advagraf, kapsuli li jerћu l- mediċina bil- mod, għandhom jittieħdu fil- pront wara li jinħarġu mill- folja.
Patients should be advised not to swallow the desiccant.
Għandu jingħad lill- pazjenti li ma jibilgħux id- desikkant.
The capsules should be swallowed with fluid (preferably water).
Il- kapsuli għandhom jinbelgħu b’ xi likwidu (preferibbilment bl- ilma).
Advagraf should generally be administered on an empty stomach or at least 1 hour before or 2 to 3 hours after a meal, to achieve maximal absorption (see section 5.2).
Biex jintlaħaq assorbiment massimu mill- ġisem, Advagraf għandu ġeneralment jittieħed fuq stonku vojt jew almenu siegħa qabel jew minn sagħtejn sa tliet sigħat wara l- ikel (ara taqsima 5. 2).
A forgotten morning dose should be taken as soon as possible on the same day.
Jekk pazjent jinsa jieħu id- doża ta ’ filgħodu, għandu jieħu dik id- doża kemm jista ’ jkun malajr dakinhar stess.
A double dose should not be taken on the next morning.
Ma għandux jieħu doża doppja l- għada filgħodu.
Duration of dosing To suppress graft rejection, immunosuppression must be maintained; consequently, no limit to the duration of oral therapy can be given.
Kemm iddum tieħu d- doża Biex tikkontrolla r- riġezzjoni tat- trapjant trid tibqa ’ żżomm l- immunosuppressjoni u għaldaqstant ma jista ’ jingħata l- ebda limitu fuq kemm tibqa ’ għaddej bit- terapija orali.