qanastek/EMEA-V3 huggingface dataset:
Children and adolescents As there has been no experience in children and adolescents, the use of febuxostat in such patients is not recommended.
13 Tfal u adoloxxenti Peress li ma kienx hemm esperjenza fit- tfal u l- adoloxxenti, l- użu ta ’ febuxostat f’ dawn il- pazjenti mhux irrakkomandat.
Liver function test is recommended prior to the
Disturbi fil- fwied Waqt studji kliniċi ta ’ fażi 3, kienu osservati anormalitajiet ħfief fit- test tal- funzjoni tal- fwied f’ pazjenti kkurati b’ febuxostat (3. 5%).
16 initiation of therapy with febuxostat and periodically thereafter based on clinical judgement (see section 5.1).
Huwa rrakkomandat test tal- funzjoni tal- fwied qabel il- bidu tat - terapija b’ febuxostat u minn hemm ’ il quddiem kull tant żmien, ibbażat fuq ġudizzju kliniku (ara sezzjoni 5. 1).
Lactose Febuxostat tablets contain lactose.
14 Lactose Pilloli febuxostat fihom lactose.
Colchicine/ indometacin/ hydrochlorothiazide/ warfarin Febuxostat can be co-administered with colchicine or indomethacin with no dose adjustment of febuxostat or the co-administered active substance being necessary.
Colchicine/ indometacin/ hydrochlorothiazide/ warfarin Febuxostat jista ’ jingħata flimkien ma ’ colchicine jew indomethacin bl’ ebda ħtieġa ta ’ aġġustament fid- doża ta ’ febuxostat jew tas- sustanza attiva li qed tingħata fl- istess waqt.
17 No dose adjustment is necessary for warfarin when administered with febuxostat.
L- ebda aġġustament fid- doża ta ’ warfarin ma hija neċessarja meta jingħata ma ’ febuxostat.
Antacids Concomitant ingestion of an antacid containing magnesium hydroxide and aluminium hydroxide has been shown to delay absorption of febuxostat (approximately 1 hour) and to cause a 32% decrease in Cmax, but no significant change in AUC was observed.
15 Antaċidi It- teħid mill- ħalq fl- istess waqt ta ’ antaċidu li fih magnesium hydroxide u aluminium hydroxide intwera li jittardja l- assorbiment ta ’ febuxostat (madwar siegħa) u li jikkawża tnaqqis ta ’ 32% fis- Cmax, iżda ma kien osservat l- ebda tibdil sinifikanti fl- AUC.
Phase 3 randomised controlled studies In randomised controlled phase 3 clinical studies, > ,1000 patients have been treated with the recommended doses of 80 mg or 120 mg (536 subjects enrolled in a 28 week study and 507 subjects enrolled in a 52 weeks study).
Studji randomised u kkontrollati ta ’ fażi 3 Fi studji kliniċi randomised u kkontrollati ta ’ fażi 3, > 1000 pazjent ġew kkurati bid- dożi rrakkomandati ta ’ 80 mg jew 120 mg (536 individwu daħlu fi studju ta ’ 28 ġimgħa u 507 individwu daħlu fi studju ta ’ 52 ġimgħa).
18 The most commonly reported ADRs (investigator assessment) are liver function abnormalities (3.5%), diarrhoea (2.7%), headache (1.8%), nausea (1.7%), rash (1.5%).
L- aktar ADRs rrapportati b’ mod komuni (valutazzjoni ta ’ l- investigatur) huma anormalitajiet fil - funzjoni tal- fwied (3. 5%), dijarea (2. 7%), uġigħ ta ’ ras (1. 8%), tqalligħ (1. 7%), raxx (1. 5%).
19 Musculoskeletal and connective tissue disorders
Disturbi muskolu- skeltrali u tal - connective tissue
Psychiatric disorders *
Disturbi psikjatriċi
Diarrhoea, nausea and vomiting are more frequent in patients concomitantly treated with colchicine ** No serious rashes or severe hypersensitivity reactions were noted in the clinical studies.
* Dijarea, tqalligħ u rimettar huma aktar frekwenti f’ pazjenti kkurati fl- istess waqt b’ colchicine ** Ma kienu nnutati l- ebda raxx serju jew reazzjonijiet severi ta ’ sensittività eċċessiva fl- istudji kliniċi.
These treatment-related events were either not reported or reported at a lower frequency for these doses, in the pivotal Phase 3 studies:
Dawn 17 l- avvenimenti relatati mal- kura ma kienux irrapportati jew irrapportati bi frekwenza aktar baxxa għal dawn id- dożi, fl- istudji pivotali ta ’ Fażi 3:
In each phase 3 pivotal study, ADENURIC demonstrated superior ability to lower and maintain serum uric acid levels compared to allopurinol.
F’ kull studju pivotali ta ’ Fażi 3, ADENURIC wera ħila superjuri biex ibaxxi u jżomm il- livelli ta ’ uric acid fis- serum meta mqabbel ma ’ allopurinol.
The primary efficacy endpoint in each study was the proportion of patients whose last 3 monthly serum uric acid levels were < 6.0 mg/ dl (357 µmol/ l).
L- mira primarja ta ’ l- effikaċja f’ kull studju kienet il- proporzjon ta ’ pazjenti li kellhom l- aħħar 3 livelli ta ’ kull xahar ta ’ uric acid fis- serum < 6. 0 mg/ dl (357 µmol/ l).
21 Table 2 summarises the primary efficacy endpoint results:
Tabella 2 tiġbor ir- riżultati tal- mira primarja ta ’ l- effikaċja:
Study
Tabella 2 Proporzjon ta ’ Pazjenti b’ Livelli ta ’ Uric Acid fis- Serum < 6. 0 mg/ dl (357µmol/ l) L- Aħħar Tliet Visti ta ’ Kull Xahar
ADENURIC 80 mg QD 48% *
Allopurinol
Figure 1 Mean Serum Uric Acid Levels Combined Phase 3 Studies
Figura 1 Livelli Medji Kombinati ta ’ Uric Acid fis- Serum fl- Istudji ta ’ Fażi 3
10 Mean (±SEM) Serum Uric Acid Level (mg/ dL)
) L 10
Note:
19 Nota:
22 The APEX Study evaluated efficacy in 40 patients with renal impairment (i. e., baseline serum creatinine > 1.5 mg/ dl and < =2.0 mg/ dl).
Il- mira primarja fis- sottogrupp ta ’ pazjenti b’ indeboliment renali L- Istudju APEX ivvaluta l- effikaċja f’ 40 pazjent b’ indeboliment renali (i. e., linja bażi tal- krejatinina fis- serum > 1. 5 mg/ dl u < =2. 0 mg/ dl).
Two years of data from the Phase 3 Open Label Extension study showed that the maintenance of serum urate levels < 6 mg/ dl (< 357 µmol/ l) resulted in a decrease in the incidence of gout flares with less than 3% of subjects requiring treatment for a flare (i. e. more than 97% of patients did not require treatment for a flare) at Month 16-24.
Sentejn ta ’ tagħrif mill- istudju ta ’ Estensjoni Open Label ta ’ Fażi 3 wera li manteniment ta ’ livelli ta ’ urate fis- serum ta ’ < 6 mg/ dl (< 357 µmol/ l) wassal għal tnaqqis fl- inċidenza ta ’ rkadar tal- gotta, b’ inqas minn 3% ta ’ l- individwi jinħtieġu kura għal rikaduta (i. e. aktar minn 97% tal- pazjenti ma kellhomx bżonn kura għal rikduta) f’ Xahar 16- 24.
Population pharmacokinetic/ pharmacodynamic analyses were conducted in 211 patients with hyperuricemia and gout, treated with ADENURIC 40-240 mg QD.
20 Saru analiżi tal- farmakokinetika/ farmakodinamika tal- popolazzjoni f’ 211- il pazjent b’ iperuriċimja u gotta, kkurati b’ ADENURIC 40- 240 mg QD.
In general, febuxostat pharmacokinetic parameters estimated by these analyses are consistent with those obtained 23 from healthy subjects, indicating that healthy subjects are representative for pharmacokinetic/ pharmacodynamic assessment in the patient population with gout.
Ġeneralment, il- parametri farmakokinetiċi ta ’ febuxostat stmati minn dawn l- analiżi huma konsistenti ma ’ dawk miksuba minn individwi b’ saħħithom, u dan jindika li ndividwi b’ saħħithom huma rappreżentattivi għall- valutazzjoni farmakokinetika/ farmakodinamika fil- popolazzjoni ta ’ pazjenti bil- gotta.
Metabolism Febuxostat is extensively metabolized by conjugation via uridine diphosphate glucuronosyltransferase (UDPGT) enzyme system and oxidation via the cytochrome P450 (CYP) system.
Metaboliżmu Febuxostat huwa metabolizzat b’ mod estensiv permezz ta ’ konjugazzjoni permezz tas- sistema ta ’ l - enżima uridine diphosphate glucuronosyltransferase (UDPGT) u ta ’ ossidazzjoni permezz tas- sistema taċ- ċitokromju P450 (CYP).
24 Hepatic impairment Following multiple doses of 80 mg of ADENURIC in patients with mild (Child-Pugh Class A) or moderate (Child-Pugh Class B) hepatic impairment, the Cmax and AUC of febuxostat and its metabolites did not change significantly compared to subjects with normal hepatic function.
Indeboliment epatiku Wara dożi multipli ta ’ 80 mg ta ’ ADENURIC f’ pazjenti b’ indeboliment epatiku ħafif (Child- Pugh Klassi A) jew moderat (Child- Pugh Klassi B), Cmax u l- AUC ta ’ febuxostat u l- metaboliti tiegħu ma nbidlux b’ mod sinifikanti meta mqabbel ma ’ individwi b’ funzjoni epatika normali.
Age There were no significant changes observed in AUC of febuxostat or its metabolites following multiple oral doses of ADENURIC in elderly as compared to younger healthy subjects.
21 Età Ma kienu osservati l- ebda tibdiliet sinifikanti fl- AUC ta ’ febuxostat jew tal- metaboliti tiegħu wara dożi orali multipli ta ’ ADENURIC fl- anzjani kif imqabbel ma ’ individwi b’ saħħithom iżgħar.
Carcinogenesis, mutagenesis, impairment of fertility In male rats, a statistically significant increase in urinary bladder tumours (transitional cell papilloma and carcinoma) was found only in association with xanthine calculi in the high dose group, at approximately 11 times human exposure.
Karċinoġeniċità, mutaġenesi, indeboliment fil- fertilità F’ firien maskili, żjieda statistikament sinifikanti fit- tumuri tal- bużżieqa ta ’ l- awrina (papilloma taċ - ċellula transitorja u karċinoma) nstabet biss f’ assoċjazzjoni ma ’ kalkuli ta ’ xanthine fil- grupp b’ doża għolja, ta ’ madwar 11- il darba l- esponiment uman.
Tablet core Lactose monohydrate Microcrystalline cellulose Magnesium stearate Hydroxypropylcellulose 25 Croscarmellose sodium Silica, colloidal hydrated
Qalba tal- pillola Lactose monohydrate Microcrystalline cellulose Magnesium stearate Hydroxypropylcellulose Croscarmellose sodium Silica, colloidal hydrated
6.2 Incompatibilities
22 6. 2 Inkompatibilitajiet
ADENURIC 120 mg is available in pack sizes of 28 and 84 film-coated tablets.
ADENURIC 120 mg huwa disponibbli f’ daqsijiet tal- pakkett ta ’ 28 u 84 pillola miksija b’ rita.
27 ANNEX II
23 ANNESS II
AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
DETENTUR( I) TA ’ L- AWTORIZZAZZJONI TAL - MANIFATTURA RESPONSABBLI GĦALL- HRUĠ TAL - LOTT B.
MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
DETENTUR (I) TA ’ L- AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI GĦALL- HRUĠ TAL- LOTT >
Patheon France 40 Boulevard de Champaret FR-38300 Bourgoin Jallieu France
Patheon France 40 Boulevard de Champaret FR- 38300 Bourgoin Jallieu Franza
• CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE IMPOSED ON THE MARKETING AUTHORISATION HOLDER
• KUNDIZZJONIJIET JEW RESTRIZZJONIJIET FUQ IL- FORNIMENT U L- UŻU IMPOSTI FUQ ID- DETENTUR TA ’ L- AWTORIZZAZZJONI GĦAT- TQEGĦID FIS - SUQ Prodott mediċinali jingħata bir- riċetta tat- tabib.
Medicinal product subject to medical prescription.
• KUNDIZZJONIJIET JEW RESTRIZZJONIJIET FIR- RIGWARD TA ’ L- UŻU MINGĦAJR PERIKLU U EFFETTIV TAL- PRODOTT MEDIĊINALI
• CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
Ma jgħoddx f’ dan il- każ.
Not applicable
• KUNDIZZJONIJIET OĦRA
• OTHER CONDITIONS
Sistema ta ’ farmakovigilanza
Pharmacovigilance system The MAH must ensure that the system of pharmacovigilance, as described in version 2.0 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.
Id- Detentur ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- Suq għandu jiżgura li s- sistema ta ’ farmakoviġilanza, kif deskritta fil- verżjoni 2. 0 ippreżentata fis- Sezzjoni 1. 8. 1. ta ’ l- Applikazzjoni ta ’ l - Awtorizzazzjoni ghat- Tqegħid fis- Suq, tkun fis- seħħ u li din tkun 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 2.0 (19 February 2008) 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 2. 0 (19 Frar 2008) tal- Pjan tal- Ġestjoni tar- Riskju (RMP) ippreżentaat fis- Sezzjoni 1. 8. 2. ta ’ l- Applikazzjoni ghall- Awtorizzazzjoni ghat- Tqegħid fis- Suq u kull aggornament sussegwenti tal- RMP miftiehem mill- CHMP.
29 ANNEX III
25 ANNESS III
31 PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON
27 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
ADENURIC 80 mg film-coated tablets Febuxostat
ADENURIC 80 mg pilloli miksija b’ rita Febuxostat
Each tablet contains 80 mg febuxostat.
Kull pillola fiha 80 mg febuxostat.
Also contains lactose monohydrate.
Fih ukoll lactose monohydrate.
BATCH NUMBER Lot:
NUMRU TAL- LOTT
33 PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON
29 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
35 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
31 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI
ADENURIC 80 mg tablets Febuxostat
Pilloli ADENURIC 80 mg Febuxostat
Mon Tue Wed Thurs Fri Sat Sun
It- Tnejn It- Tlieta L- Erbgħa Il- Ħamis Il- Ġimgħa Is- Sibt Il- Ħadd
36 PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON
32 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
ADENURIC 120 mg film-coated tablets Febuxostat
ADENURIC 120 mg pilloli miksija b’ rita Febuxostat
Each tablet contains 120 mg febuxostat.
Kull pillola fiha 120 mg febuxostat.
40 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
36 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI
ADENURIC 120 mg tablets Febuxostat
Pilloli ADENURIC 120 mg Febuxostat
41 B.
37 B.
42 PACKAGE LEAFLET:
38 FULJETT TA ’ TAGĦRIF:
What ADENURIC is and what it is used for 2.
X’ inhu ADENURIC u għalxiex jintuża 2.
Before you take ADENURIC 3.
Qabel ma tieħu ADENURIC 3.
How to take ADENURIC 4.
Kif għandek tieħu ADENURIC 4.
Possible side effects 5 How to store ADENURIC 6.
Effetti sekondarji li jista ’ jkollu 5.
Further information
Kif taħżen ADENURIC 6.
WHAT ADENURIC IS AND WHAT IT IS USED FOR
X’ INHU ADENURIC U GĦALXIEX JINTUŻA
ADENURIC tablets are used to treat gout, which is associated with an excess of a chemical called uric acid (urate) in the body.
Pilloli ADENURIC huma wżati għall- kura tal- gotta, li hija assoċjata ma ’ kimika żejda msejħa uric acid (urate) fil- ġisem.
In some people, the amount of uric acid builds up in the blood and may become too high to remain soluble.
F’ xi persuni, l- ammont ta ’ uric acid jiżdied fid- demm u jista ’ jsir għoli wisq biex jibqa ’ mdewweb.
When this happens, urate crystals may form in and around the joints and kidneys.
Meta jiġri dan, kristalli ta ’ urate jistgħu jiffurmaw ġewwa u madwar il- ġogi u l - kliewi.
These crystals can cause sudden, severe pain, redness, warmth and swelling in a joint (known as a gout attack).
Dawn il- kristalli jistgħu jikkawżaw uġigħ sever f’ daqqa, ħmura, sħana u nefħa f’ ġog (magħruf bħala attakk tal- gotta).
Left untreated, larger deposits called tophi (TOE-FI) may form in and around joints.
Jekk ma tiġix ikkurata, jistgħu jiffuraw depositi akbar magħrufa bħala tofi (TOE- FI) ġewwa u madwar il- ġogi.
These tophi may cause joint and bone damage.
Dawn it- tofi jistgħu jikkawżaw ħsara fil- ġog u fl- għadam.
ADENURIC works by reducing uric acid levels.
ADENURIC jaħdem billi jnaqqas il- livelli ta ’ uric acid.
Keeping uric acid levels low by taking ADENURIC once every day stops crystals building up, and over time it reduces symptoms.
Iż- żamma ta ’ uric acid f’ livell baxx permezz tat- teħid ta ’ ADENURIC darba kuljum twaqqaf iż- żjieda tal- kristalli, u maż- żmien tnaqqas is- sintomi.
Keeping uric acid levels sufficiently low for a long enough period can also shrink tophi.
Iż- żamma ta ’ uric acid f’ livell baxx biżżejjed għall- perjodu twil biżżejjed tista ’ wkoll iċċekken it- tofi.
BEFORE YOU TAKE ADENURIC
QABEL MA TIEĦU ADENURIC
Do not take ADENURIC if you are: • If you are allergic (hypersensitive) to febuxostat, the active ingredient of ADENURIC, or any of the other ingredients in these tablets.
Tieħux ADENURIC • Jekk inti allerġiku/ a (tbagħti minn sensittività eċċessiva) għal febuxostat, is - sustanza attiva ta ’ ADENURIC, jew sustanzi oħra f’ dawn il- pilloli.
Take special care with ADENURIC Tell your doctor before you start to take this medicine: • If you have or have had heart failure or heart problems • If you are being treated for high uric acid levels as a result of cancer disease or Lesch-Nyhan syndrome (a rare inherited condition in which there is too much uric acid in the blood) • If you have thyroid problems
Oqgħod attent ħafna b’ ADENURIC Għid lit- tabib tiegħek qabel tibda ’ tieħu din il- mediċina: • Jekk inti għandek jew kellek insuffiċjenza tal- qalb jew problemi tal- qalb • Jekk inti qed tiġi kkurat għal- livelli għolja ta ’ uric acid bħala riżultat ta ’ marda tal- kanċer jew tas- sindrome Lesch- Nyhan (kundizzjoni ereditarja rari fejn ikun hemm uric acid żejjed fid - demm) • Jekk għandek problemi tat- tirojde
If you are having a gout attack at the moment (a sudden onset of severe pain, tenderness, redness, warmth and swelling in a joint), wait for the gout attack to subside before first starting treatment with ADENURIC.
Jekk bħalissa għandek attakk tal- gotta (bidu f’ daqqa ta ’ uġigħ qawwi, sensittività, ħmura, sħana u nefħa f’ ġog), stenna sakemm l- attakk tal- gotta jbatti qabel tibda kura b’ ADENURIC.
43 For some people, gout attacks may flare up when starting certain medicines that control uric acid levels.
39 Għal xi persuni, attakki tal- gotta jistgħu jirkadaw meta jinbdew ċertu mediċini li jikkontrollaw il - livelli ta ’ uric acid.
Not everyone gets flares, but you could get a flare-up even if you are taking ADENURIC, and especially during the first weeks or months of treatment.
Mhux kulħadd ikollu rkadar, iżda int jista ’ jkollok rikaduta anki jekk qed tieħu ADENURIC, u speċjalment waqt l- ewwel ġimgħat jew xhur ta ’ kura.
It is important to keep taking ADENURIC even if you have a flare, as ADENURIC is still working to lower uric acid.
Huwa mportanti li tkompli tieħu ADENURIC anki jekk ikollok rikaduta, għax ADENURIC ikun għadu qed jaħdem biex ibaxxi l- uric acid.
Over time, gout flares will occur less often and be less painful if you keep taking ADENURIC every day.
Jekk tkompli tieħu ADENURIC kuljum, maż- żmien, rkadar tal- gotta jseħħ inqas ta ’ spiss u jkun b’ inqas uġigħ.
Your doctor will often prescribe other medicines, if they are needed, to help prevent or treat the symptoms of flares (such as pain and swelling in a joint).
Jekk hemm bżonn, it- tabib tiegħek jista ’ spiss jippreskrivilek mediċini oħra, biex jgħin jipprevjeni jew jikkura s- sintomi ta ’ rkadar (bħal uġigħ u nefħa f’ ġog).
Your doctor may ask you to have blood tests to check that your liver is working normally.
It- tabib tiegħek jista ’ jsaqsik biex tagħmel testijiet tad- demm biex jiċċekkja li l- fwied tiegħek qed jaħdem b’ mod normali.
Taking 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.
Meta tieħu 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.
It is especially important to tell your doctor or pharmacist if you are taking medicines containing any of the following substances as they may interact with ADENURIC and your doctor may wish to consider necessary measures: • Mercaptopurine (used to treat cancer) • Azathioprine (used to reduce immune response) • Theophylline (used to treat asthma) • Warfarin (used to thin your blood if you have a heart condition)
Huwa mportanti ħafna li tgħid lit- tabib jew lill- ispiżjar tiegħek jekk qed tieħu mediċini li fihom xi wieħed minn dawn is- sustanzi li ġejjin għax dawn jistgħu jirreaġixxu ma ’ ADENURIC u t- tabib tiegħek jista ’ jkun jixtieq jikkunsidra miżuri neċessarji: • Mercaptopurine (użat biex jikkura l- kanċer) • Azathioprine (użat biex inaqqas ir- rispons immuni) • Theophylline (użat biex jikkura l- ażżma) • Warfarin (użat biex iraqqaq id- demm tiegħek jekk għandek kundizzjoni tal- qalb)
Taking ADENURIC with food and drink The tablets should be taken by mouth and can be taken with or without food.
Meta tieħu ADENURIC ma ’ l- ikel u max- xorb Il- pilloli għandhom jittieħdu mill- ħalq u jistgħu jittieħdu ma ’ l- ikel jew mingħajr ikel.
Pregnancy and breast-feeding It is not known if ADENURIC may harm your unborn child.
Tqala u Treddigħ Mhux magħruf jekk ADENURIC jistax jagħmel ħsara lit- tarbija li għada ma twelditx tiegħek.
Tell your doctor if you think you are pregnant or if you are planning to become pregnant as ADENURIC should not be used during pregnancy.
Għid lit - tabib tiegħek jekk taħseb li inti tqila jew jekk qed tippjana li toħroġ tqila għax ADENURIC m’ għandux jintuża waqt it- tqala.
It is not known if ADENURIC may pass into human breast milk.
Mhux magħruf jekk ADENURIC jistax jgħaddi fil- ħalib tas- sider uman.
You should not use ADENURIC if you are breast feeding, or if you are planning to breastfeed.
M’ għandek tuża ADENURIC jekk qed tredda ’, jew jekk qed tippjana li tredda ’.
Driving and using machines No studies on the effects of ADENURIC on the ability to drive and use machines have been performed.
Sewqan u tħaddim ta ’ magni Ma sarux studji dwar l- effett ta ’ ADENURIC fuq il- ħila li ssuq u li tħaddem magni.
However, you should be aware that you may experience dizziness, sleepiness and numbness or tingling sensation during treatment and should not drive or operate machines if affected.
Madankollu, għandek tkun taf li jista ’ jkollok sturdament, ngħas u sensazzjoni ta ’ tnemnim jew tingiż waqt il- kura u jekk affettwat m’ għandekx issuq jew tħaddem magni.
Important information about some of the ingredients of ADENURIC ADENURIC tablets contain lactose (a type of sugar).
Tagħrif importanti dwar xi wħud mis- sustanzi ta ’ ADENURIC Pilloli ADENURIC fihom lactose (tip ta ’ zokkor).
If you have been told that you have an intolerance to some sugars contact your doctor before taking this medicine.
Jekk qalulek li għandek intolleranza għal xi zokkrijiet, kellem lit- tabib tiegħek qabel tieħu din il- mediċina.
HOW TO TAKE ADENURIC
KIF GĦANDEK TIEĦU ADENURIC
Always take ADENURIC exactly as your doctor has told you.
Dejjem għandek tieħu ADENURIC skond il- parir tat- tabib.
ADENURIC is available as either an 80 mg tablet or a 120 mg tablet.
ADENURIC huwa disponibbli bħala pillola ta ’ 80 mg jew bħala pillola ta ’ 120 mg.
Your doctor will have prescribed the strength most suitable for you.
It- tabib tiegħek ser jippreskrivilek il- qawwa l- aktar xierqa għalik.
• The usual dose is one tablet daily.
• Id- doża tas- soltu hija pillola waħda kuljum.
The back of the blister pack is marked with the days of the week to help you check that you have taken a dose each day. • The tablets should be taken by mouth and can be taken with or without food.
Il- parti ta ’ wara tal- pakkett tal- folja huwa mmarkat bil- ġranet tal- ġimgħa biex jgħinek tiċċekkja li inti ħadt doża kuljum. • Il- pilloli għandhom jittieħdu mill- ħalq u jistgħu jittieħdu ma ’ l- ikel jew mingħajr ikel.
It is important that you do not stop taking ADENURIC unless your doctor tells you to.
40 Huwa mportanti li ma tieqafx tieħu ADENURIC sakemm it- tabib tiegħek ma jgħidlekx biex tagħmel hekk.
Continue to take ADENURIC every day even when you are not experiencing gout flare or attack.
Kompli ħu ADENURIC kuljum anki meta inti m’ għandekx rikaduta jew attakk tal- gotta.
44 If you take more ADENURIC than you should In the event of an accidental overdose ask your doctor what to do, or contact your nearest accident and emergency department.
Jekk tieħu ADENURIC aktar milli suppost F’ każ ta ’ doża eċċessiva, staqsi lit- tabib tiegħek għall- parir dwar x’ għandek tagħmel, jew ikkuntattja l - eqreb dipartiment tal- emerġenza.
If you forget to take ADENURIC If you miss a dose of ADENURIC take it as soon as you remember unless it is almost time for your next dose, in which case miss out the forgotten dose and take your next dose at the normal time.
Jekk tinsa tieħu ADENURIC Jekk tinsa doża ta ’ ADENURIC ħudha hekk kif tiftakar sakemm ma jkunx kważi sar il- ħin biex tieħu d- doża li jmiss tiegħek.
Do not take a double dose to make up for a forgotten dose.
F’ dan il- każ għandek taqbes id- doża li tkun insejt u tieħu d- doża li jmiss tiegħek fil- ħin normali.
If you stop taking ADENURIC Do not stop taking ADENURIC without the advice of your doctor even if you feel better.
Jekk tieqaf tieħu ADENURIC Twaqqafx ADENURIC mingħajr il- parir tat- tabib tiegħek anki jekk tħossok aħjar.
If you stop taking ADENURIC your uric acid levels may begin to rise and your symptoms may worsen due to the formation of new crystals of urate in and around your joints and kidneys.
Jekk tieqaf tieħu ADENURIC il- livelli ta ’ uric acid tiegħek jistgħu jibdew jogħlew u s- sintomi tiegħek jistgħu jmorru għal agħar minħabba l- formazzjoni ta ’ kristalli ġodda ta ’ urate ġewwa u madwar il- ġogi u l- kliewi tiegħek.
Like all medicines, ADENURIC can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, ADENURIC jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
Common side effects (more than 1 in 100 patients but less than 1 in 10 patients) are: • abnormal liver test results • diarrhoea • headache • rashes • feeling sick
Effetti sekondarji komuni (aktar minn 1 f’ kull 100 pazjent iżda inqas minn 1 f’ kull 10 pazjent) huma: • riżultati tat- test tal- fwied mhux normali • dijarea • uġigħ ta ’ ras • raxx • tħossok ma tiflaħx
Uncommon side effects (more than 1 in 1,000 patients but less than 1 in 100 patients) are: • weight gain, increased appetite, change in blood sugar levels (diabetes) of which a symptom may be excessive thirst, increased blood fat levels • erectile difficulties and/ or loss of sex drive • difficulty in sleeping • dizziness, numbness or tingling sensation, sleepiness, impaired sense of taste, reduction in sensation of touch • abnormal ECG heart tracing • hot flushes or blushing (e. g. redness of the face or neck), increased blood pressure • cough, shortness of breath, flu-like symptoms • dry mouth, abdominal pain/ discomfort or wind, heartburn/ indigestion, constipation, more frequent passing of stools • vomiting • itching, hives, skin inflammation or discolouration, other type of skin conditions • muscle cramp, pain/ ache in muscles/ joints, bursitis or arthritis (inflammation of joints usually accompanied by pain, swelling and/ or stiffness) • blood in the urine, abnormal frequent urination, kidney stones, abnormal urine tests (increased level of proteins in urine), a reduction in the ability of the kidneys to function properly • fatigue, localised swelling due to the retention of fluids in the tissues (oedema) • changes in blood chemistry or amount of blood cells (abnormal blood test results)
Effetti sekondarji mhux komuni (aktar minn 1 f’ kull 1, 000 pazjent iżda inqas minn 1 f’ kull 100 pazjent) huma: • żjieda fil- piż, żjieda fl- aptit, bidla fil- livelli ta ’ zokkor fid- demm (dijabete) li jista ’ jkollha bħala sintomu għatx eċċessiv, żjieda fil- livelli ta ’ xaħam fid- demm • diffikultajiet erettili u/ jew telf tax- xewqa għas- sess • diffikultà biex torqod • sturdament, sensazzjoni ta ’ tnemnim jew tingiż, ngħas, sensazzjoni tat- togħma mnaqqsa, tnaqqis fis- sensazzjoni tal- mess • traċċar tal- qalb b’ ECG mhux normali • fwawar ta ’ sħana jew fwawar fil- wiċċ (e. ż. ħmura tal- wiċċ jew ta ’ l- għonq), żjieda fil- pressjoni tad- demm • sogħla, qtugħ ta ’ nifs, sintomi bħal ta ’ l- influwenza • ħalq xott, uġigħ addominali/ skomdu jew gass, ħruq ta ’ stonku/ indiġestjoni, stitikezza, purgar aktar frekwenti • rimettar • ħakk, ħorriqija, infjammazzjoni jew bidla fil- kulur tal- ġilda, tipi oħra ta ’ kondizzjonijiet tal- ġilda • bugħawwieġ, uġigħ/ weġgħat fil- muskoli/ ġogi, borżite jew artrite (infjammazzjoni tal- ġogi ġeneralment b’ uġigħ, nefħa u/ jew ebusija) • demm fl- awrina, awrina frekwenti aktar mis- soltu, ġebel fil- kilwa, testijiet ta ’ l- awrina mhux normali (żjieda fil- livell ta ’ proteini fl- awrina), tnaqqis fil- ħila tal- kliewi li jaħdmu kif suppost • għeja, nefħa lokalizzata minħabba ż- żamma ta ’ fluwidi fit- tessuti (edima)
Rare side effects (more than 1 in 10,000 patients but less than 1 in 1,000 patients) are: • weakness • nervousness • feeling thirsty • feeling your heartbeat
Effetti sekondarji rari (aktar minn 1 f’ kull 10, 000 pazjent iżda inqas minn 1 f’ kull 1, 000 pazjent) huma: • debbulizza • nervi • tħossok bil- għatx • tħoss it- taħbit ta ’ qalbek
45 If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Jekk xi wieħed mill- effetti sekondarji jiggrava jew jekk tinnota xi effetti sekondarji li mhumiex imsemmijin f’ dan il- fuljett, jekk jogħġbok, għid lit- tabib jew lill- ispiżjar tiegħek.
HOW TO STORE ADENURIC
KIF TAĦŻEN ADENURIC
• Keep out of the reach and sight of children. • Do not use after the expiry date which is stated on the carton and the tablet blister foil after ‘ EXP .’ The expiry date refers to the last day of that month. • This medicinal product does not require any special storage conditions.
Id- data ta ’ skadenza tirreferi għall- aħħar ġurnata ta ’ dak ix- xahar. • Din il- mediċina m’ għandhiex bżonn ħażna speċjali.
What ADENURIC contains
X’ fih ADENURIC:
The active substance is febuxostat.
Is- sustanza attiva hija febuxostat.
Each tablet contains 80 mg or 120 mg of febuxostat.
Kull pillola fiha 80 mg jew 120 mg ta ’ febuxostat.
Tablet core: lactose monohydrate, microcrystalline cellulose, magnesium stearate, hydroxypropylcellulose, croscarmellose sodium, colloidal hydrated silica.
Qalba tal- pillola: lactose monohydrate, microcrystalline cellulose, magnesium stearate, hydroxypropylcellulose, croscarmellose sodium, colloidal hydrated silica.
Film-coating:
Kisja b’ rita:
Opadry II yellow, 85F42129 containing: polyvinyl alcohol, titanium dioxide (E171), macrogols 3350, talc, iron oxide yellow (E172)
Opadry II isfar, 85F42129 li fih: polyvinyl alcohol, titanium dioxide (E171), macrogols 3350, talc, iron oxide isfar (E172)
What ADENURIC looks like and contents of the pack
Id- Dehra ta ’ ADENURIC u l- kontenuti tal- pakkett:
ADENURIC film-coated tablets are pale yellow to yellow in colour and capsule shaped.
ADENURIC, pilloli miksija b’ rita huma ta ’ kulur isfar ċar għal isfar u b’ forma ta ’ kapsula.
The 80 mg film-coated tablets are marked on one side with ‘ 80’.
Il- pilloli miksija b’ rita ta ’ 80 mg huma mmarkati fuq naħa waħda b ’ ‘ 80 ’.
The 120 mg film-coated tablets are marked on one side with ‘ 120’.
Il- pilloli miksija b’ rita ta ’ 120 mg huma mmarkati fuq naħa waħda b ’ ‘ 120 ’.
ADENURIC is supplied in 2 blisters of 14 tablets (28 tablet pack), or 6 blisters of 14 tablets (84 tablet pack).
ADENURIC huwa fornut f’ 2 folji ta ’ 14- il pillola (pakkett ta ’ 28 pillola), jew f’ 6 folji ta ’ 14- il pillola (pakkett ta ’ 84 pillola).
Marketing Authorisation Holder Beaufour Ipsen Pharma 24 rue Erlanger 75781 Paris Cedex 16 France
Id- Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- Suq Beaufour Ipsen Pharma 24 rue Erlanger 75781 Paris Cedex 16 Franza
Manufacturer Patheon France 40 boulevard de Champaret 38300 Bourgoin Jallieu France
42 Il- Manifattur Patheon France 40 boulevard de Champaret 38300 Bourgoin Jallieu Franza
46 For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder.
Għal kull tagħrif dwar dan il- prodott mediċinali, jekk jogħġbok ikkuntattja lir- rappreżentant lokali tad - Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- Suq:
България Beaufour Ipsen Pharma 24 rue Erlanger F-75781 Paris Cedex 16 France Tél: + 33 - 1 - 44 96 13 13
България Beaufour Ipsen Pharma 24 rue Erlanger F- 75781 Paris Cedex 16 Franza Tél: + 33 - 1 - 44 96 13 13
Ελλάδα, Κύπρος, Malta Ipsen EΠΕ Αγ.
43 Ελλάδα, Κύπρος, Malta Ipsen EΠΕ Αγ.
Detailed information on this medicine is available on the European Medicines Agency (EMEA) website http: / /www. emea. europa. eu/
Informazzjoni dettaljata dwar din il- mediċina tinsab fuq il- website ta ’ l- Aġenzija Ewropeja dwar il - Mediċini (EMEA) http: // www. emea. europa. eu /.
EU Number EU/ 1/ 06/ 364/ 001 EU/ 1/ 06/ 364/ 002 EU/ 1/ 06/ 364/ 003 EU/ 1/ 06/ 364/ 004 EU/ 1/ 06/ 364/ 005 EU/ 1/ 06/ 364/ 006 EU/ 1/ 06/ 364/ 007 EU/ 1/ 06/ 364/ 008 EU/ 1/ 06/ 364/ 009
Numru ta ’ l- EU EU/ 1/ 06/ 364/ 001 EU/ 1/ 06/ 364/ 002 EU/ 1/ 06/ 364/ 003 EU/ 1/ 06/ 364/ 004 EU/ 1/ 06/ 364/ 005 EU/ 1/ 06/ 364/ 006 EU/ 1/ 06/ 364/ 007 EU/ 1/ 06/ 364/ 008 EU/ 1/ 06/ 364/ 009
Invented name Adrovance Adrovance Adrovance Adrovance Adrovance Adrovance Adrovance Adrovance Adrovance
Isem inventat Adrovance Adrovance Adrovance Adrovance Adrovance Adrovance Adrovance Adrovance Adrovance
Strength 70 mg/ 2800 IU 70 mg/ 2800 IU 70 mg/ 2800 IU 70 mg/ 2800 IU 70 mg/ 2800 IU 70 mg/ 5600 IU 70 mg/ 5600 IU 70 mg/ 5600 IU 70 mg/ 5600 IU
Qawwa 70 mg/ 2800 IU 70 mg/ 2800 IU 70 mg/ 2800 IU 70 mg/ 2800 IU 70 mg/ 2800 IU 70 mg/ 5600 IU 70 mg/ 5600 IU 70 mg/ 5600 IU 70 mg/ 5600 IU
Pharmaceutical Form Tablet Tablet Tablet Tablet Tablet Tablet Tablet Tablet Tablet
Għamla farmaċewtika Pillola Pillola Pillola Pillola Pillola Pillola Pillola Pillola Pillola
Route of Administration Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use
Mnejn jingħata Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali
Packaging blister (alu/ alu) blister (alu/ alu) blister (alu/ alu) blister (alu/ alu) blister (alu/ alu) blister (alu/ alu) blister (alu/ alu) blister (alu/ alu) blister (alu/ alu)
Il- pakkett folja (alu/ alu) folja (alu/ alu) folja (alu/ alu) folja (alu/ alu) folja (alu/ alu) folja (alu/ alu) folja (alu/ alu) folja (alu/ alu) folja (alu/ alu)
Package size 2 tablets 4 tablets 6 tablets 12 tablets 40 tablets 2 tablets 4 tablets 12 tablets 40 tablets
Daqs tal- pakkett 2 pilloli 4 pilloli 6 pilloli 12- il pillola 40 pillola 2 pilloli 4 pilloli 12- il pillola 40 pillola
ADROVANCE 70 mg/ 2800 IU tablets
ADROVANCE 70 mg/ 2800 IU pilloli
ADROVANCE reduces the risk of vertebral and hip fractures.
ADROVANCE inaqqas ir- riskju ta 'ksur vertebrali u tal- ġenbejn.
The recommended dosage is one ADROVANCE tablet once weekly.
Id- doża rakkomandata hija pillola ADROVANCE waħda darba fil- ġimgħa.
Due to the nature of the disease process in osteoporosis, ADROVANCE is intended for long-term use.
Minħabba n- natura tal- proċess tal- marda fl- ostoeporożi, ADROVANCE hu intiż biex jintuża fuq perijodu ta 'żmien twil.
ADROVANCE must be taken with water only (not mineral water) at least 30 minutes before the first food, beverage, or medicinal product (including antacids, calcium supplements and vitamins) of the day.
ADROVANCE għandu jittieħed ma 'l- ilma biss (mhux ilma minerali) ta' l- anqas 30 minuta qabel l - ewwel ikel, xorb jew prodott mediċinali (li jinkludi antaċidi, supplimenti tal- kalċju u vitamini) tal- jum.
• ADROVANCE should only be swallowed after getting up for the day with a full glass of water (not less than 200ml or 7fl. oz.).
• ADROVANCE għandu jinbela ’ biss ma ’ tazza mimlija bl- ilma (mhux anqas minn 200 ml jew 7uq. fl.) filgħodu wara li l- pazjent iqum.
• Patients should not lie down for at least 30 minutes after taking ADROVANCE.
2 • Il- pazjenti m' għandhomx jimteddu għal talanqas 30 minuta wara li jieħdu ADROVANCE.
2 • ADROVANCE should not be taken at bedtime or before arising for the day.
• ADROVANCE m' għandux jittieħed fil- ħin ta 'qabel l- irqad jew qabel il- ħin tal- qawmien għall - jum.
The equivalence of intake of 2800 IU of vitamin D3 weekly in ADROVANCE to daily dosing of vitamin D 400 IU has not been studied.
L- ekwivalenza ta ’ teħid ta ’ 2800 IU ta ’ vitamina D3 kull ġimgħa f’ ADROVANCE mad- doża ta ’ kuljum ta ’ 400 IU ta ’ vitamina D ma ġietx mistħarrġa.
ADROVANCE is not recommended for patients with renal impairment where GFR is less than 35ml/ min, due to lack of experience.
ADROVANCE mhux rakkomandat għal pazjenti b’ indeboliment renali meta l- GFR hija anqas minn 35ml/ min, minħabba nuqqas ta ’ esperjenza.
ADROVANCE has not been studied in children and adolescents and therefore should not be given to them.
Użu fi tfal u adoloxxenti ADROVANCE ma ġiex studjat fi tfal u adoloxxenti u għalhekk m' għandux jingħatalhom.
Patients should be instructed that if they miss a dose of ADROVANCE they should take one tablet on the morning after they remember.
Il- pazjenti għandhom jiġu mgħarrfa li jekk jaqbzu doża ta ’ ADROVANCE għandhom jieħdu pillola fl - għodwa ta ’ wara li jiftakru.
ADROVANCE is not recommended for patients with renal impairment where GFR is less than 35ml/ min (see section 4.2).
ADROVANCE mhux rakkomandat għal pazjenti b’ indeboliment renali meta l- GFR hija anqas minn 35ml/ min (ara sezzjoni 4. 2).
Hypocalcaemia must be corrected before initiating therapy with ADROVANCE (see section 4.3).
L- ipokalċemija għandha tiġi korretta qabel ma tinbeda t- terapija b’ ADROVANCE (ara sezzjoni 4. 3).
Other disorders affecting mineral metabolism (such as vitamin D deficiency and hypoparathyroidism) should also be effectively treated before starting ADROVANCE.
Mard ieħor li jaffetwa l- metaboliżmu minerali (bħal defiċjenza fil- vitamina D u ipoparatirojdiżmu) għandhom jiġu wkoll ittrattati effettivament qabel ma jinbeda ADROVANCE.
The content of vitamin D in ADROVANCE is not suitable for correction of vitamin D deficiency.
Il- kontenut ta ’ vitamina D f’ ADROVANCE mhix adattata għal korrezzjoni ta ’ defiċjenza tal- vitamina D.
In patients with these conditions, serum calcium and symptoms of hypocalcaemia should be monitored during therapy with ADROVANCE.
F’ pazjenti b’ dawn il - kundizzjonijiet, il- kalċju fis- serum u sintomi ta ’ ipokalċemija għandhom jiġu monitorjati waqt terapija b’ ADROVANCE.
ADROVANCE is only intended for use in postmenopausal women and therefore it should not be used during pregnancy or in breast-feeding women.
ADROVANCE jintuża biss għal użu f’ nisa wara l- menopawża u għalhekk m’ għandux jiġi użat waqt it- tqala jew f’ nisa li jreddgħu.
There are no adequate data from the use of ADROVANCE in pregnant women.
Ma hemm l- ebda dejta adekwata dwar l- użu ta ’ ADROVANCE f’ nisa tqal.
However, there is no information to indicate that ADROVANCE affects a patient’ s ability to drive or operate machines.
Madankollu, mhemmx informazzjoni li tindika li ADROVANCE jaffettwa l- ħila ta 'pazjent biex issuq jew iħaddem magni.
No additional adverse reactions have been identified for ADROVANCE.
L- ebda reazzjoni avversa addizzjonali ma ġiet identifikata għal ADROVANCE.
Osteonecrosis of the jaw is generally associated with tooth extraction and / or local infection (including osteomyelitis).
L- osteonekrosi tax- xedaq ġeneralment hija assoċjata mal- qligħ tas- snien u/ jew infezzjoni lokali (fosthom osteomjelite).
In case of overdose with ADROVANCE, milk or antacids should be given to bind alendronate.
F’ kaz ta ’ doża eċċessiva b’ ADROVANCE, ħalib jew antaċidi għandhom jingħataw biex jintrabtu ma 'alendronate.
ADROVANCE is a combination tablet containing the two active substances alendronate sodium trihydrate and colecalciferol (vitamin D3).
ADROVANCE hija pillola kombinata li fiha ż- żewġ sustanzi attivi alendronate sodium trihydrate u colecalciferol (vitamina D3).
ADROVANCE studies The effect of ADROVANCE (alendronate 70 mg/ vitamin D3 2800 IU) on vitamin D status was demonstrated in a 15-week, multinational study that enrolled 682 osteoporotic post-menopausal women (serum 25-hydroxyvitamin D at baseline: mean, 56 nmol/ l [22.3 ng/ ml]; range, 22.5- 225 nmol/ l [9-90 ng/ ml]).
Studji dwar ADROVANCE L- effett ta ’ ADROVANCE (alendronate 70 mg/ vitamin D3 2800 IU) fuq l- istat tal- vitamina D kien muri fi studju multinazzjonali ta ’ 15- il ġimgħa li rreġistra 682 nisa ta ’ wara l- menopawża bl - osteoporożi (25- hydroxyvitamin D fis- serum fil- linja bażi: medja, 56 nmol/ l [22. 3 ng/ ml]; firxa, 22. 5 - 225 nmol/ l [9- 90 ng/ ml]).
Patients received the lower strength (70 mg/ 2800 IU) of ADROVANCE (n=350) or FOSAMAX (alendronate) 70 mg (n=332) once a week; additional vitamin D supplements
Pazjenti ngħataw l- qawwa l- baxxa (70 mg/ 2800 IU) ta ’ ADROVANCE) (n=350) jew FOSAMAX (alendronate) 70 mg (n=332) darba fil- ġimgħa; supplimenti addizzjonali ta ’ vitamina D kienu projbiti.
After 15 weeks of treatment, the mean serum 25-hydroxyvitamin D levels were significantly higher (26%) in the ADROVANCE (70 mg/ 2800 IU) group (56 nmol/ l [23 ng/ ml]) than in the alendronate-only group (46 nmol/ l [18.2 ng/ ml]).
Wara 15- il ġimgħa ta ’ trattament, il- livelli medji ta ’ 25- hydroxyvitamin D fis- serum kienu sinifikattivament ogħla (26%) fil- grupp ADROVANCE (70 mg/ 2800 IU) (56 nmol/ l [23 ng/ ml]) milli fil- grupp ta ’ alendronate biss (46 nmol/ l [18. 2 ng/ ml]).
32%, respectively), through week 15.
Il- perċentwali ta ’ pazjenti b’ insuffiċjenza ta ’ vitamina D (25- hydroxyvitamin D fis- serum < 37. 5 nmol/ l [< 15 ng/ ml]) kien sinifikattivament imnaqqas bi 62. 5% b’ ADROVANCE (70 mg/ 2800 IU) kontra alendronate biss (12% kontra 32%, rispettivament), matul ġimgħa 15.
The percentage of patients with vitamin D deficiency (serum 25-hydroxyvitamin D < 22.5 nmol/ l [<  9 ng/ ml]) was significantly reduced by 92% with ADROVANCE (70 mg/ 2800 IU) vs. alendronate-only (1% vs 13%, respectively).
Il- perċentwali ta ’ pazjenti b’ insuffiċjenza ta ’ vitamina D (25- hydroxyvitamin D fis- serum ≤22. 5 nmol/ l [≤9 ng/ ml]) kien sinifikattivament imnaqqas bi 92% b’ ADROVANCE (70 mg/ 2800 IU) kontra alendronate biss (1% kontra 13%, rispettivament).
In this study, mean 25-hydroxyvitamin D levels in patients with vitamin D insufficiency at baseline (25- hydroxyvitamin D, 22.5 to 37.5 nmol/ l [9 to < 15 ng/ ml]) increased from 30 nmol/ l (12.1 ng/ ml) to 40 nmol/ l (15.9 ng/ ml) at week 15 in the ADROVANCE (70 mg/ 2800 IU) group (n=75) and decreased from 30 nmol/ l (12.0 ng/ ml) at baseline to 26 nmol/ l (10.4 ng/ ml) at week 15 in the alendronate-only group (n=70).
F' dan l- istudju, livelli medji ta ’ 25- hydroxyvitamin D f’ pazjenti b’ insuffiċjenza ta ’ vitamina D fil- linja bażi ta 'riferiment (25 - hydroxyvitamin D, 22. 5 għal 37. 5 nmol/ l [9 għal < 15 ng/ ml]) żdiedu minn 30 nmol/ l (12. 1 ng/ ml) għal 40 nmol/ l (15. 9 ng/ ml) f’ ġimgħa 15 fil- grupp ADROVANCE (70 mg/ 2800 IU) (n=75) u naqsu minn 30 nmol/ l (12. 0 ng/ ml) fil- linja bażi għal 26 nmol/ l (10. 4 ng/ ml) f’ ġimgħa 15 fil- grupp alendronate- biss (n=70).
The alendronate component in the ADROVANCE (70 mg/ 2800 IU) combination tablet is bioequivalent to the alendronate 70 mg tablet.
Il- komponent alendronate fil- pillola kombinata ADROVANCE (70 mg/ 2800 IU) huwa bijoekwivalenti għal pillola ta ’ 70 mg alendronate.
Absorption In healthy adult subjects (males and females), following administration of ADROVANCE after an overnight fast and two hours before a meal, the mean area under the serum-concentration-time curve (AUC0-120 hrs) for vitamin D3 (unadjusted for endogenous vitamin D3 levels) was 296.4 ng• hr/ ml.
Assorbiment Wara l- għoti ta ’ ADROVANCE 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- 120 hrs) għal
The bioavailability of the 2800 IU vitamin D3 in ADROVANCE is similar to 2800 IU vitamin D3 administered alone.
Il- bijodisponibiltà tal- 2800 IU vitamina D3 f’ ADROVANCE hija simili għal 2800 IU D3 mogħtija waħeda.
The mean half-life of vitamin D3 in the serum following an oral dose of ADROVANCE (70 mg/ 2800 IU) is approximately 24 hours.
Il- half- life medja ta ’ vitamina D3 fis- serum wara doża orali ta ’ ADROVANCE (70 mg/ 2800 IU) hija madwar 24 siegħa.
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
4 January 2007
4 ta ’ Jannar 2007
ADROVANCE 70 mg/ 5600 IU tablets
ADROVANCE 70 mg/ 5600 IU pilloli
12 • Patients should not lie down for at least 30 minutes after taking ADROVANCE.
13 • Il- pazjenti m' għandhomx jimteddu għal talanqas 30 minuta wara li jieħdu ADROVANCE.
• ADROVANCE should not be taken at bedtime or before arising for the day.
• ADROVANCE m' għandux jittieħed fil- ħin ta 'qabel l- irqad jew qabel il- ħin tal- qawmien għall - jum.
The equivalence of intake of 5600 IU of vitamin D3 weekly in ADROVANCE to daily dosing of vitamin D 800 IU has not been studied.
L- ekwivalenza ta ’ teħid ta ’ 5600 IU ta ’ vitamina D3 kull ġimgħa f’ ADROVANCE mad- doża ta ’ kuljum ta ’ 800 IU ta ’ vitamina D ma ġietx mistħarrġa.
It is very important that the full dosing instructions are provided to, and are understood by the patient (see section 4.2).
Huwa importanti ħafna li l- istruzzjonijet kompluti fuq l- iddożar huma mogħtija, u mifhuma mill- pazjent (ara sezzjoni 4. 2).
13 While no increased risk was observed in extensive clinical trials with alendronate, there have been rare (post-marketing) reports of gastric and duodenal ulcers, some of which were severe and with complications (see section 4.8).
14 Waqt li l- ebda żjieda fir- riskju ma kienet osservata fi provi kliniċi estensivi b’ alendronate, kien hemm rapporti (ta ’ wara t- tqegħid fis- suq) rari ta ’ ulċeri gastriċi u duwodenali, li xi wħud minnhom kienu serji u bil- kumplikazzjonijiet (ara sezzjoni 4. 8).
General disorders and administration site conditions:
17
Insufficiency is associated with negative calcium balance, bone loss, and increased risk of skeletal fracture.
L- insuffiċjenza hija assoċjata ma ’ bilanċ tal- kalċju negattiv, telf ta ’ l- għadma, u riskju aktar ta ’ fratturi
In severe cases, deficiency results in secondary hyperparathyroidism, hypophosphataemia, proximal muscle weakness and osteomalacia, further increasing the risk of falls and fractures in osteoporotic individuals.
F’ każijiet serji, id- defiċjenza tirriżulta f’ iperparatirojdiżmu sekondarju, ipofosfatemija, dgħjufija tal- muskoli prossimali u osteomalaċja, li tkompli żżid ir- riskju ta ’ waqgħat u fratturi f’ individwi osteoporotiċi.
ADROVANCE studies The effect of the lower dose of ADROVANCE (alendronate 70 mg/ vitamin D3 2800 IU) on vitamin D status was demonstrated in a 15-week, multinational study that enrolled 682 osteoporotic post- menopausal women (serum 25-hydroxyvitamin D at baseline: mean, 56 nmol/ l [22.3 ng/ ml]; range, 22.5-225 nmol/ l [9-90 ng/ ml]).
Studji dwar ADROVANCE L- effett ta ’ ADROVANCE (alendronate 70 mg/ vitamin D3 2800 IU) fuq l- istat tal- vitamina D kien muri fi studju multinazzjonali ta ’ 15- il ġimgħa li rreġistra 682 nisa ta ’ wara l- menopawża bl - osteoporożi (25- hydroxyvitamin D fis- serum fil- linja bażi: medja, 56 nmol/ l [22. 3 ng/ ml]; firxa, 22. 5 - 225 nmol/ l [9- 90 ng/ ml]).
Patients received the lower strength (70 mg/ 2800 IU) of ADROVANCE (n=350) or FOSAMAX (alendronate) 70 mg (n=332) once a week; additional vitamin
Pazjenti ngħataw l- qawwa l- baxxa (70 mg/ 2800 IU) ta ’ ADROVANCE (n=350) jew FOSAMAX (alendronate) 70 mg (n=332) darba fil- ġimgħa; supplimenti addizzjonali ta ’ vitamina D kienu projbiti.
The percentage of patients with vitamin D deficiency (serum 25- hydroxyvitamin D <  22.5 nmol/ l [<  9 ng/ ml]) was significantly reduced by 92% with ADROVANCE (70 mg/ 2800 IU) vs. alendronate-only (1% vs 13%, respectively).
Il- perċentwali ta ’ pazjenti b’ insuffiċjenza ta ’ vitamina D (25- hydroxyvitamin D fis- serum < 22. 5 nmol/ l [ < 9 ng/ ml]) kien sinifikattivament imnaqqas bi 92% b’ ADROVANCE (70 mg/ 2800 IU) kontra alendronate biss (1% kontra 13%, rispettivament).
In this study, mean 25- hydroxyvitamin D levels in patients with vitamin D insufficiency at baseline (25- hydroxyvitamin D, 22.5 to 37.5 nmol/ l [9 to < 15 ng/ ml]) increased from 30 nmol/ l (12.1 ng/ ml) to 40 nmol/ l (15.9 ng/ ml) at week 15 in the ADROVANCE (70 mg/ 2800 IU) group (n=75) and decreased from 30 nmol/ l (12.0 ng/ ml) at baseline to 26 nmol/ l (10.4 ng/ ml) at week 15 in the alendronate-only group (n=70).
F' dan l- istudju, livelli medji ta ’ 25- hydroxyvitamin D f’ pazjenti b’ insuffiċjenza ta ’ vitamina D fil- linja bażi ta 'riferiment (25 - hydroxyvitamin D, 22. 5 għal 37. 5 nmol/ l [9 għal < 15 ng/ ml]) żdiedu minn 30 nmol/ l (12. 1 ng/ ml) għal 40 nmol/ l (15. 9 ng/ ml) f’ ġimgħa 15 fil- grupp ADROVANCE (70 mg/ 2800 IU) (n=75) u naqsu minn 30 nmol/ l (12. 0 ng/ ml) fil- linja bażi għal 26 nmol/ l (10. 4 ng/ ml) f’ ġimgħa 15 fil- grupp alendronate- biss (n=70).