qanastek/EMEA-V3 huggingface dataset:
Hycamtin capsules must not be opened or crushed.
Il- kapsuli Hycamtin m’ għandhomx jinfetħu jew jitfarrku.
If the capsules are punctured or leaking, you should immediately wash your hands thoroughly with soap and water.
Jekk il- kapsuli huma mifqugħin jew ħiereġ xi likwidu minnhom, għandek taħsel idejk sew bl- ilma u s- sapun immedjatament.
If you get it in your eyes, wash them immediately with gently flowing water for at least 15 minutes.
Jekk iċċappas għajnejk, aħsilhom immedjatament bl- ilma nieżel bil- mod għal 15- il minuta mill- anqas.
Consult your doctor/ healthcare provider after eye contact or if you experience a skin reaction.
Ikkonsulta mat- tabib jew ma ’ min qed jieħu ħsieb saħħtek jekk ikun hemm kuntatt ma ’ l- għajnjen jew jekk ikollok xi reazzjoni tal- ġilda.
71 Taking out a capsule These capsules come in special packaging to prevent children removing them
72 Meta toħroġ il- kapsula Dawn il- kapsuli jiġu f’ pakkett speċjali biex ma ’ jkunux jistgħu jinfetħu mit- tfal.
Separate one capsule: tear along the cutting lines to separate one “ pocket” from the strip.
Issepara kapsula waħda: aqta ’ mal- linji ta ’ qtugħ biex tissepara “ borża "waħda mill- istrixxa.
Peel back the outer layer: starting at the coloured corner, lift and peel over the pocket.
Iġbed lura l- istrat ta ’ barra: billi tibda mir- rokna kulurita, erfa ’ u qaxxar fuq il- borża.
Push out the capsule: gently push one end of the capsule through the foil layer.
Imbotta 'l- kapsula ‘ l barra: imbotta bil- mod naħa waħda tal- kapsula mill- istrat ta ’ l- istrixxa.
If you take more Hycamtin than you should Contact a doctor or pharmacist immediately for advice if you have taken too many capsules or if a child has accidentally taken the medicine.
Jekk tieħu Hycamtin aktar milli suppost Itlob parir minn għand tabib jew spiżjar immedjatament jekk ħadd wisq kapsuli jew jekk tifel/ tifla ħa l- mediċina biż- żball.
If you forget to take Hycamtin Do not take a double dose to make up for a forgotten dose.
Jekk tinsa tieħu Hycamtin M’ għandekx tieħu doża doppja biex tpatti għal kull doża li tkun insejt tieħu.
Just take the next dose at the scheduled time.
Ħu d- doża li jmiss fil- ħin kif suppost.
Like all medicines, Hycamtin can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, Hycamtin jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
Serious side effects: tell your doctor These very common side effects may affect more than 1 in 10 people treated with Hycamtin. • Signs of infections.
73 Effetti sekondarji serji: għid lit- tabib tiegħek Dawn l- effetti sekondarji komuni ħafna jistgħu jaffettwaw aktar minn persuna waħda minn kull 10 ikkurati b’ Hycamtin. • Sinjali ta ’ infezzjoni.
- local symptoms such as sore throat or urinary problems (for example, a burning
deni deterjorament serju tal- kundizzjoni ġenerali tiegħek sintomi lokali bħal ġriżmejk jaħarquk jew problemi bl- awrina (per eżempju, tħoss ħruq meta tgħaddi l- awrina, li tista ’ tkun infezzjoni fl- awrina)
sensation when urinating, which may be a urinary infection). • Diarrhoea.
• Dijareja.
This can be serious.
Din tista ’ tkun serja.
If you have more than 3 episodes of diarrhoea per day you should contact your doctor immediately. • occasionally severe stomach pain, fever and possibly diarrhoea (rarely with blood) can be signs of bowel inflammation (colitis)
Jekk ikollok aktar minn tlett episodji ta ’ dijareja f’ ġurnata għandek tkellem lit- tabib tiegħek immedjatament. • xi kultant uġigħ ta ’ żaqq qawwi, deni u possibbilment dijareja (rarament bid- demm) jistgħu jkunu sinjali ta ’ infjammazzjoni tal- musrana (kolite).
This rare side effect may affect up to 1 in 1000 people treated with Hycamtin). • Lung inflammation (interstitial lung disease):
Dan l- effett sekondarju rari jista ’ jaffettwa minn 1 sa 1000 persuna ikkurati b’ Hycamtin
- cough
•
- fever
Jinkludu sinjali bħal: - diffikulta ’ biex tieħu nifs - sogħla - deni
Very common side effects These may affect more than 1 in 10 people treated with Hycamtin • Feeling generally weak and tired (temporary anaemia).
Effetti sekondarji komuni ħafna Dawn jistgħu jaffettwaw aktar minn persuna waħda minn kull 10 ikkurati b’ Hycamtin • Tħossok ġeneralment debboli u għajjien/ a (anemija temporanja).
This can lead to severe bleeding from relatively small injuries such as a small cut.
Dan jista ’ jwassal għal fsada serja minn ġrieħi relattivament żgħar bħal qatgħa żgħira.
Talk to your doctor for advice on how to minimize the risk of bleeding. • Weight loss and loss of appetite (anorexia); tiredness; weakness; feeling unwell • Feeling sick (nausea), being sick (vomiting); stomach pain; constipation • Inflammation and ulcers of the mouth, tongue or gums • High body temperature (fever) • Hair loss.
Kellem lit - tabib tiegħek għal parir dwar kif tnaqqas ir- riskju ta ’ fsada. • Tnaqqis fil- piż u nuqqas t’ aptit (anoressija); għeja; debbulizza, u ma ’ tħossokx f’ sikktek • Tħossok ma tiflaħx (dardir); iħossok ħażin (rimettar); uġigħ fl- istonku; stitikezza • Infjammazzjoni u ulċeri fil- ħalq, fl- ilsien jew fil- ħanek • Temperatura tal- ġisem għolja (deni) • Telf ta ’ xagħar.
Common side effects These may affect up to 1 in 10 people treated with Hycamtin • Allergic or hypersensitivity reactions (including rash) • Yellow skin • Itching sensation • Muscle pain.
Effetti sekondarji komuni Dawn jistghu jaffettwaw sa persuna wahda minn kull 10 persuni kkurati b’ Hycamtin • Reazzjonijiet allerġiċi jew ta ’ sensittività eċċessiva (inkluż raxx) • Ġilda safra • Sensazzjoni ta ’ tekil • Uġigħ fil- muskoli → Għid lit- tabib jekk kwalunkwe waħda minn dawn issir problema
Rare side effects These may affect up to 1 in 1000 people treated with Hycamtin. • Severe allergic or anaphylactic reactions • Swelling caused by fluid build up (angioedema) • Itchy rash (or hives).
Effetti sekondarji rari Dawm jistgħu jaffettwaw sa persuna waħda minn kull 1000 ikkurati b’ Hycamtin. • Reazzjonijiet allerġiċi jew anafilattici serji
73 If you get side effects → Tell your doctor or pharmacist if any of the side effects become severe or troublesome, or if you notice any side effects not listed in this leaflet,
Jekk ikollok effetti sekondarji → Għid lit- tabib jew lill- ispiżjar tiegħek jekk xi wieħed minn dawn l- effetti sekondarji isiru severi jew ituk il- problemi, jew jekk tinnota xi effetti sekondarji m’ humiex imsemmija f’ dan il- fuljett,.
How to store Hycamtin
Kif taħżen Hycamtin
• The active substance is topotecan.
• Is- sustanza attiva hija topotecan.
Each capsule contains topotecan hydrochloride equivalent to 0.25 mg or 1 mg of topotecan. • The other ingredients are: hydrogenated vegetable oil, glyceryl monostearate, gelatin, titanium dioxide (E171), and for 1 mg capsules only, red iron oxide (E172).
Kull kapsula fiha topotecan hydrochloride ekwivalenti għal 0. 25mg jew 1mg ta ’ topotecan. • L- ingredjenti l- oħra huma: hydrogenated vegetable oil, glyceryl monostearate, ġelatina, titanium dioxide (E171), u għall- kapsuli ta ’ 1 mg biss, iron oxide aħmar (E172).
Capsules are printed with black ink that contains black iron oxide (E172), shellac, anhydrous ethanol, propylene glycol, isopropyl alcohol, butanol, concentrated ammonia solution and potassium hydroxide.
Il- kapsuli huma mmarkati b’ inka sewda li fiha iron oxide iswed (E172), shellac, anhydrous ethanol, propylene glycol, isopropyl alcohol, butanol, soluzzjoni konċentrata ta ’ ammonia u potassium hydroxide.
Hycamtin 0.25 mg capsules are white to yellowish white and imprinted with ‘ Hycamtin’ and ‘ 0.25 mg’.
Il- kapsuli Hycamtin 0. 25 mg huma bojod għal bojod fl- isfar u mmarkati b ’ 'Hycamtin ’ u ’ 0. 25mg ’.
Hycamtin 1 mg capsules are pink and imprinted with ‘ Hycamtin’ and ‘ 1 mg’.
Il- kapsuli Hycamtin 1 mg huma roża u mmarkati b ’ 'Hycamtin ’ u ’ 1 mg ’.
Hycamtin is available in packs containing 10 capsules of 0.25 mg or 1 mg topotecan.
Hycamtin jinsab f’ pakketti ta ’ 10 kapsuli li fihom 0. 25 mg jew 1 mg ta ’ topotecan.
74 For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
Għal kull tagħrif dwar dan il- prodott mediċinali, jekk jogħġbok ikkuntattja lir- rappreżerntant lokali tad- Detentur ta ’ l- Awtroizzazzjoni għat- tqegħid fis- Suq:
België/ Belgique/ Belgien GlaxoSmithKline s. a. / n. v.
75 Luxembourg/ Luxemburg België/ Belgique/ Belgien GlaxoSmithKline s. a. / n. v.
Č eská republika GlaxoSmithKline s. r. o.
Malta Česká republika GlaxoSmithKline s. r. o.
Nederland GlaxoSmithKline BV Tel: + 31 (0)30 6938100 nlinfo@gsk. com
Nederland GlaxoSmithKline BV Tel: + 31 (0) 30 6938100 nlinfo@ gsk. com Norge
Eesti GlaxoSmithKline Eesti OÜ Tel: + 372 6676 900 estonia@gsk. com
Österreich Eesti GlaxoSmithKline Eesti OÜ Tel: + 372 6676 900 estonia@ gsk. com
España GlaxoSmithKline, S. A.
Portugal España GlaxoSmithKline, S. A.
Portugal Beecham Portuguesa, Produtos Farmacêuticos e Químicos, Lda Tel: + 351 21 412 95 00 FI. PT@gsk. com
Beecham Portuguesa, Produtos Farmacêuticos e Químicos, Lda Te: + 351 21 412 95 00 FI. PT@ gsk. com
Ireland GlaxoSmithKline (Ireland) Limited Tel: + 353 (0)1 4955000
Slovenija Ireland GlaxoSmithKline (Ireland) Limited Tel: + 353 (0) 1 4955000 Ísland
75 Ísland GlaxoSmithKline ehf.
GlaxoSmithKline ehf.
Italia GlaxoSmithKline S. p. A.
76 Suomi/ Finland Italia GlaxoSmithKline S. p. A.
Latvija GlaxoSmithKline Latvia SIA Tel: + 371 67312687 lv-epasts@gsk. com
United Kingdom Latvija GlaxoSmithKline Latvia SIA Tel: + 371 67312687 lv- epasts@ gsk. com
United Kingdom GlaxoSmithKline UK Tel: +44 (0) 800 221441 customercontactuk@gsk. com
GlaxoSmithKline UK Tel: +44 (0) 800 221441 customercontactuk@ gsk. com
This leaflet was last approved in
Dan il- fuljett kien approvat l- aħħar:
Detailed information on this medicine product is available on the European Medicines Agency (EMEA) web site: http: / /www. emea. europa. eu/.
Informazzjoni dettaljata dwar din il- mediċina tinsab fuq il- website ta ’ l- Aġenzija Ewropea dwar il - Mediċini (EMEA) http: // www. emea. europa. eu /.
What is Icandra?
X’ inhu Icandra?
Icandra is a medicine that contains the active substances vildagliptin and metformin hydrochloride.
Icandra huwa mediċina li fiha s- sustanzi attivi vildagliptin u metformina kloroidrat (metformin hydrochloride).
It is available as oval tablets (light yellow:
Huwa disponibbli f’ pilloli ovali (isfar ċar:
50 mg vildagliptin and 850 mg metformin hydrochloride; dark yellow:
50 mg vildagliptin u 850 mg metformina kloridrat; isfar skur:
50 mg vildagliptin and 1,000 mg metformin hydrochloride).
50 mg vildagliptin u 1, 000 mg metformina kloridrat).
This medicine is the same as Eucreas, which is already authorised in the European Union (EU).
Din il- mediċina hija l- istess bħal Eucreas, li huwa diġà awtorizzat fl- Unjoni Ewropea (UE).
The company that makes Eucreas has agreed that its scientific data can be used for Icandra.
Il - kumpanija li tipproduċi Eucreas qablet li l- informazzjoni xjentifika tagħha tista ’ tintuża għal Icandra.
What is Icandra used for?
Għal xiex jintuża Icandra?
Icandra is used to treat type 2 diabetes (non-insulin-dependent diabetes).
Icandra jintuża għat- trattament tad- dijabete tat- tip 2 (dijabete mhux dipendenti mill- insulina).
It is used in patients whose disease is insufficiently controlled with the maximum tolerated dose of metformin taken alone or who are already taking the combination of vildagliptin and metformin as separate tablets.
Jintuża f’ pazjenti li l- marda tagħhom ma tkunx biżżejjed ikkontrollata bid- doża massima tollerata ta ’ metformina meħuda waħedha jew li jkunu diġà qed jieħdu l- kombinazzjoni ta ’ vidagliptin u metformina f’ pilloli separati.
How is Icandra used?
Kif jintuża Icandra?
The recommended dose of Icandra is one tablet twice a day, with one tablet taken in the morning and one in the evening.
Id- doża rakkomandata ta ’ Icandra hija pillola waħda darbtejn kuljum, waħda filgħodu u l- oħra filgħaxija.
Patients already taking vildagliptin and metformin should switch to Icandra containing the same amounts of each active substance.
L- għażla tad- doża inizjali tiddependi mid- doża ta ’ metformina li l- pazjent attwalment ikun qed jieħu, iżda d- doża rakkomandata hija 50 mg vildagliptin u 1, 000 mg metformina darbtejn kuljum. l- pazjenti li diġà jkunu qed jieħdu vildagliptin u metformina għandhom jaqilbu għal Icandra li fih l - istess dożi ta ’ kull sustanza attiva.
Doses of vildagliptin above 100 mg are not recommended.
Mhumiex rakkomandati dożi ogħla minn 100 mg vildagliptin.
Taking Icandra with or just after food may reduce any stomach problems caused by metformin.
Meta wieħed jieħu Icandra mal- ikel jew eżatt wara, jistgħu jitnaqqsu problemi tal- istonku kkawżati mill - metformina.
Icandra should not be used in patients who have moderate or severe problems with their kidneys or who have problems with their liver.
Icandra ma għandux jintuża f’ pazjenti li għandhom problemi moderati jew gravi bil- kliewi jew bil - fwied tagħhom.
Elderly patients taking Icandra should have their kidney function monitored regularly.
Fil- pazjenti anzjani li jkunu qed jieħdu Icandra ikun xieraq li jkollhom il- funzjoni tal - kliewi ssorveljata regolarment.
Icandra is not recommended for use in patients aged over 75 years.
Icandra mhuwiex rakkomandat għall- użu fil- pazjenti ta ’ età ogħla minn 75 sena.
How does Icandra work?
Kif jaħdem Icandra?
Icandra contains two active substances, which each have a different mode of action.
Id- dijabete tat- tip 2 hija marda li minħabba fiha l- frixa (pankreas) ma tipproduċix biżżejjed insulina biex tikkontrolla l- livell ta ’ glukożju (zokkor) fid- demm jew meta l- ġisem ma jkunx jista ’ juża l -
1 Previously known as Vildagliptin/ Metformin Hydrochloride Novartis.
1 Preċedentement magħrufa bħala Icandra.
© European Medicines Agency, 2009.
© European Medicines Agency, 9.
Reproduction is authorised provided the source is acknowledged. levels of incretin hormones in the blood, vildagliptin stimulates the pancreas to produce more insulin when blood glucose levels are high.
Icandra fih żewġ sustanzi attivi li kull waħda minnhom għandha azzjoni differenti.
Vildagliptin also reduces the amount of glucose made by the liver, by increasing insulin levels and decreasing the levels of the hormone glucagon.
Vildagliptin inaqqas ukoll l - ammont ta ’ glukożju prodott mill- fwied, billi jżid il- livelli tal- insulina u jnaqqas il- livelli tal- ormon glukagon.
Metformin works mainly by inhibiting glucose production and reducing its absorption in the gut.
Il- metformina fundamentalment taħdem billi tinibixxi l- produzzjoni ta ’ glukożju u tnaqqas l- assorbiment tiegħu fl- intestin.
As a result of the action of both substances, the blood glucose is reduced and this helps to control type 2 diabetes.
Bħala riżultat tal- azzjoni taż- żewġ sustanzi attivi, jitnaqqas il- glukożju preżenti fid- demm u dan jgħin biex tiġi kkontrollata d- dijabete tat- tip 2.
How has Icandra been studied?
Kif ġie studjat Icandra?
Vildagliptin on its own was approved by the EU in September 2007 under the name Galvus, and metformin has been available in the EU since 1959.
F’ Settembru 2007, vildagliptin kien ġie approvat waħdu mill- UE bl- isem ta ’ Galvus, filwaqt li l - metformina ilha disponibbli fl- UE sa mill- 1959.
Vildagliptin can be used with metformin in type 2 diabetes patients who are not satisfactorily controlled on metformin alone.
Vildagliptin jista ’ jintuża mal- metformina fil- pazjenti li jbatu mid- dijabete tat- tip 2 li l- marda tagħhom mhijiex ikkontrollata b’ mod sodisfaċenti bil- metformina waħedha.
The studies of Galvus as an add-on to metformin were used to support the use of Icandra in the same indication.
L- istudji mwettqa fuq Galvus ġew integrati ma ’ dawk fuq il- metformina biex isostnu l- użu ta ’ Icandra għall- istess indikazzjoni.
The studies measured the levels of a substance in the blood called glycosylated haemoglobin (HbA1c), which gives an indication of how well the blood glucose is controlled.
L- istudji kejlu l- livell ta ’ sustanza magħrufa bħala emoglobina glikosilata (HbA1c) fid- demm li tagħti indikazzjoni tal- effikaċja tal- kontroll tal- glukożju fid- demm.
The applicant also presented the results of two studies showing that the active substances in the two strengths of Icandra were absorbed in the body in the same way as when they were taken as separate tablets.
L- applikant ippreżenta wkoll ir- riżultati ta ’ żewġ studji li juru li s- sustanzi attivi f’ żewġ dożaġġi ta ’ Icandra ġew assorbiti fil- ġisem bl- istess mod bħalma kieku ttieħdu bħala pilloli separati.
What benefit has Icandra shown during the studies?
X' benefiċċji wera Icandra fl- istudji mwettqa?
Vildagliptin was more effective than placebo (a dummy treatment) at reducing HbA1c levels when it was added to metformin.
Vildagliptin kien aktar effikaċi mill- plaċebo (trattament finta) fit- tnaqqis tal- livelli ta ’ HbA1 meta dan ġie miżjud mal- metformina.
Patients adding vildagliptin had a fall in HbA1c levels of 0.88% after 24 weeks from a starting level of 8.38%.
Il- pazjenti li żiedu vildagplitin kellhom tnaqqis fil- livelli ta ’ HbA1c ta ’ 0. 88% wara 24 ġimgħa minn livell inizjali li kien 8. 38%.
In contrast, patients adding placebo had smaller changes in HbA1c levels, with a rise of 0.23% from a starting level of 8.30%.
B’ kuntrast ta ’ dan, il- pazjenti li żiedu l - plaċebo kellhom tibdiliet iżgħar fil- livelli ta ’ HbA1c, b’ żieda ta ’ 0. 23% minn livell inizjali ta ’ 8. 30%.
What is the risk associated with Icandra?
X’ inhu r- riskju assoċjat ma ’ Icandra?
The most common side effects with Icandra (seen in more than 1 patient in 10) are nausea (feeling sick), vomiting, diarrhoea, abdominal (tummy) pain and loss of appetite.
L- effetti sekondarji l- aktar komuni b’ Icandra (li dehru f’ aktar minn pazjent 1 minn kull 10) huma nawżea (dardir), remettar, dijarrea, uġigħ addominali (ta ’ żaqq) u telf tal- aptit.
For the full list of all side effects reported with Icandra, see the Package Leaflet.
Għal- lista sħiħa tal - effetti sekondarji irrappurtati b’ Icandra, ara l- Fuljett ta ’ Tagħrif.
Icandra should not be used in people who may be hypersensitive (allergic) to vildagliptin, metformin or any of the other ingredients.
Icandra ma għandux jintuża minn persuni li jistgħu jkunu ipersensittivi (allerġiċi) għal vildagliptin, il - metformina jew għal kwalunkwe ingredjent ieħor.
It must not be used in patients who have diabetic ketoacidosis (high levels of ketones and acids in the blood), diabetic pre-coma, problems with their kidneys or liver, conditions that may affect the kidneys, or a disease that causes a reduced supply of oxygen to the tissues such as failure of the heart or lungs or a recent heart attack.
Ma għandux jintuża f’ pazjenti li jbatu minn ketoaċidożi dijabetika (livelli għoljin ta ’ ketoni u aċidi fid- demm), pre- koma dijabetika, problemi bil - fwied jew bil- kliewi, kundizzjonijiet li jistgħu jolqtu l- kliewi, jew marda li tikkawża provvista mnaqqsa ta ’ ossiġenu lit- tessuti bħal insuffiċjenza kardijaka jew tal- pulmun jew attakk tal- qalb reċenti.
It must also not be used in patients with alcohol intoxication (excessive alcohol consumption) or alcoholism, or during breast-feeding.
Barra minn hekk, ma għandux jintuża fil- pazjenti b’ intossikazzjoni alkoħolika (konsum eċċessiv ta ’ alkoħol) jew alkoħoliżmu, jew matul it- treddigħ.
For the full list of restrictions, see the Package Leaflet.
Għal- lista sħiħa ta ’ restrizzjonijiet, ara l- Fuljett ta ’ Tagħrif.
Why has Icandra been approved?
Għaliex ġie approvat Icandra?
The Committee for Medicinal Products for Human Use (CHMP) concluded that vildagliptin taken with metformin reduces blood glucose levels and the combination of the two active substances in one tablet may help patients to stick to their treatment.
Il- Kumitat għall- Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) ikkonkluda li vildagliptin meħud mal- metformina jnaqqas l- livelli ta ’ glukożju fid- demm u li l- kombinazzjoni taż- żewġ sustanzi f’ pillola waħda tista ’ tgħin lill- pazjenti jżommu t- trattament tagħhom.
Therefore, the Committee decided that the benefits of Icandra are greater than its risks for the treatment of type 2 diabetes mellitus patients who are unable to achieve sufficient glycaemic control at their maximally tolerated dose of oral metformin alone or who are already treated with the combination of vildagliptin and metformin as separate tablets.
Għalhekk, il- Kumitat iddeċieda li l- benefiċċji ta ’ Icandra huma ogħla mir- riskji tiegħu għat- trattament tal- pazjenti li jbatu mid- dijabete mellitu tat- tip 2 li ma jkunux jistgħu jiksbu biżżejjed kontroll gliċemiku fid- doża massima tollerata tagħhom ta ’ metformina orali meħuda waħedha jew li jkunu diġà ttrattati b’ kombinazzjoni ta ’ vildagliptin u metformina f’ pilloli separati.
The Committee recommended that Icandra be given marketing authorisation.
Il- Kumitat irrakkomanda li Icandra jingħata awtorizzazzjoni għat- tqegħid fis- suq.
Other information about Icandra:
Aktar tagħrif dwar Icandra:
The European Commission granted a marketing authorisation valid throughout the EU for Vildagliptin/ Metformin Hydrochloride Novartis to Novartis Europharm Limited on 1 December 2008.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fis- suq valida fl- Unjoni Ewropea kollha għal Icandra lil Novartis Europharm Limited fil- 20 ta ’ Novembru 2008.
The name of the medicine was changed to Icandra on 6 February 2009.
L- isem tal- mediċina ġie mibdul għal Icandra fis- 6 ta ’ Frar 2009.
The full EPAR for Icandra can be found here.
L- EPAR sħiħ għal Icandra jista ’ jiġi kkonsultat hawn.
This summary was last updated in 02-2009.
Dan is- sommarju kien aġġornat l- aħħar fi:
EU Number EU/ 1/ 08/ 484/ 001 EU/ 1/ 08/ 484/ 002 EU/ 1/ 08/ 484/ 003 EU/ 1/ 08/ 484/ 004 EU/ 1/ 08/ 484/ 005 EU/ 1/ 08/ 484/ 006 EU/ 1/ 08/ 484/ 007 EU/ 1/ 08/ 484/ 008 EU/ 1/ 08/ 484/ 009 EU/ 1/ 08/ 484/ 010 EU/ 1/ 08/ 484/ 011 EU/ 1/ 08/ 484/ 012 EU/ 1/ 08/ 484/ 013 EU/ 1/ 08/ 484/ 014 EU/ 1/ 08/ 484/ 015 EU/ 1/ 08/ 484/ 016 EU/ 1/ 08/ 484/ 017 EU/ 1/ 08/ 484/ 018
Numru ta ’ l- EU EU/ 1/ 08/ 484/ 001 EU/ 1/ 08/ 484/ 002 EU/ 1/ 08/ 484/ 003 EU/ 1/ 08/ 484/ 004 EU/ 1/ 08/ 484/ 005 EU/ 1/ 08/ 484/ 006 EU/ 1/ 08/ 484/ 007 EU/ 1/ 08/ 484/ 008 EU/ 1/ 08/ 484/ 009 EU/ 1/ 08/ 484/ 010 EU/ 1/ 08/ 484/ 011 EU/ 1/ 08/ 484/ 012 EU/ 1/ 08/ 484/ 013 EU/ 1/ 08/ 484/ 014 EU/ 1/ 08/ 484/ 015 EU/ 1/ 08/ 484/ 016 EU/ 1/ 08/ 484/ 017 EU/ 1/ 08/ 484/ 018
Invented name Icandra Icandra Icandra Icandra Icandra Icandra Icandra Icandra Icandra Icandra Icandra Icandra Icandra Icandra Icandra Icandra Icandra Icandra
Isem inventat Icandra Icandra Icandra Icandra Icandra Icandra Icandra Icandra Icandra Icandra Icandra Icandra Icandra Icandra Icandra Icandra Icandra Icandra
Strength 50 mg / 850 mg 50 mg / 850 mg 50 mg / 850 mg 50 mg / 850 mg 50 mg / 850 mg 50 mg / 850 mg 50 mg / 1000 mg 50 mg / 1000 mg 50 mg / 1000 mg 50 mg / 1000 mg 50 mg / 1000 mg 50 mg / 1000 mg 50 mg / 850 mg 50 mg / 850 mg 50 mg / 850 mg 50 mg / 1000 mg 50 mg / 1000 mg 50 mg / 1000 mg
Qawwa 50 mg / 850 mg 50 mg / 850 mg 50 mg / 850 mg 50 mg / 850 mg 50 mg / 850 mg 50 mg / 850 mg 50 mg / 1000 mg 50 mg / 1000 mg 50 mg / 1000 mg 50 mg / 1000 mg 50 mg / 1000 mg 50 mg / 1000 mg 50 mg / 850 mg 50 mg / 850 mg 50 mg / 850 mg 50 mg / 1000 mg 50 mg / 1000 mg 50 mg / 1000 mg
Pharmaceutical Form Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet
Għamla farmaċewtika Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita
Route of Administration Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use 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 Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali
Packaging blister (PA/ Al/ PVC/ /Al) blister (PA/ Al/ PVC/ /Al) blister (PA/ Al/ PVC/ /Al) blister (PA/ Al/ PVC/ /Al) blister (PA/ Al/ PVC/ /Al) blister (PA/ Al/ PVC/ /Al) blister (PA/ Al/ PVC/ /Al) blister (PA/ Al/ PVC/ /Al) blister (PA/ Al/ PVC/ /Al) blister (PA/ Al/ PVC/ /Al) blister (PA/ Al/ PVC/ /Al) blister (PA/ Al/ PVC/ /Al) blister (PA/ Al/ PVC/ /Al) blister (PA/ Al/ PVC/ /Al) blister (PA/ Al/ PVC/ /Al) blister (PA/ Al/ PVC/ /Al) blister (PA/ Al/ PVC/ /Al) blister (PA/ Al/ PVC/ /Al)
Il- pakkett folja (PA/ Al/ PVC // Al) folja (PA/ Al/ PVC // Al) folja (PA/ Al/ PVC // Al) folja (PA/ Al/ PVC // Al) folja (PA/ Al/ PVC // Al) folja (PA/ Al/ PVC // Al) folja (PA/ Al/ PVC // Al) folja (PA/ Al/ PVC // Al) folja (PA/ Al/ PVC // Al) folja (PA/ Al/ PVC // Al) folja (PA/ Al/ PVC // Al) folja (PA/ Al/ PVC // Al) folja (PA/ Al/ PVC // Al) folja (PA/ Al/ PVC // Al) folja (PA/ Al/ PVC // Al) folja (PA/ Al/ PVC // Al) folja (PA/ Al/ PVC // Al) folja (PA/ Al/ PVC // Al)
Package size 10 tablets 30 tablets 60 tablets 120 tablets 180 tablets 360 tablets 10 tablets 30 tablets 60 tablets 120 tablets 180 tablets 360 tablets 120 (2x60) tablets 180 (3x60) tablets 360 (6x60) tablets 120 (2x60) tablets 180 (3x60) tablets 360 (6x60) tablets
Daqs tal- pakkett 10 pilloli 30 pillola 60 pillola 120 pillola 180 pillola 360 pillola 10 pilloli 30 pillola 60 pillola 120 pillola 180 pillola 360 pillola 120 (2x60) pillola 180 (3x60) pillola 360 (6x60) pillola 120 (2x60) pillola 180 (3x60) pillola 360 (6x60) pillola
Icandra 50 mg/ 850 mg film-coated tablets
Icandra 50 mg/ 850 mg pilloli miksijin b’ rita
Icandra is indicated in the treatment of type 2 diabetes mellitus patients who are unable to achieve sufficient glycaemic control at their maximally tolerated dose of oral metformin alone or who are already treated with the combination of vildagliptin and metformin as separate tablets.
Icandra huwa indikat għall- kura ta ’ pazjenti bid- dijabete mellitus tat- tip 2 li ma jistgħux jiksbu kontroll gliċemiku xieraq bl- ogħla doża li jifilħu ta ’ metformin li jittieħed mill- ħalq waħdu jew li diġà qed jiġu kkurati b’ taħlita ta ’ vildagliptin u metformin bħala pilloli separati.
Adults Based on the patient’ s current dose of metformin, Icandra may be initiated at either the 50 mg/ 850 mg or 50 mg/ 1000 mg tablet strength twice daily, one tablet in the morning and the other in the evening.
Adulti Ibbażat fuq id- doża ta ’ metformin li jkun qed jieħu l- pazjent, Icandra jista ’ jinbeda b’ pillola ta ’ 50 mg/ 850 mg jew ta ’ 50 mg/ 1000 mg darbtejn kuljum, pillola waħda filgħodu u l- oħra filgħaxija.
Patients receiving vildagliptin and metformin from separate tablets may be switched to Icandra containing the same doses of each component.
Pazjenti li qed jirċievu vildagliptin u metformin minn pilloli separati jistgħu jinqalbu għal Icandra li jkun fih l- istess dożi ta ’ kull komponent.
Taking Icandra with or just after food may reduce gastrointestinal symptoms associated with metformin (see also section 5.2).
Jekk Icandra jittieħed ma ’ l- ikel jew eżatt wara l- ikel jista ’ jnaqqas is- sintomi gastro- intestinali assoċjati ma ’ metformin (ara wkoll sezzjoni 5. 2).
Additional information on special populations Renal impairment Icandra should not be used in patients with creatinine clearance < 60 ml/ min (see sections 4.3, 4.4 and 5.2).
Informazzjoni oħra fuq popolazzjonijiet speċjali Indeboliment renali Icandra m’ għandux jintuża f’ pazjenti bi tneħħija tal- krejatinina < 60 ml/ min (ara sezzjonijiet 4. 3, 4. 4 u 5. 2).
Hepatic impairment Icandra should not be used in patients with hepatic impairment, including those with pre-treatment alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 3 times the upper limit of normal (ULN) (see sections 4.3, 4.4 and 4.8).
Indeboliment tal- fwied Icandra m’ għandux jintuża f’ pazjenti b’ indeboliment tal- fwied, inklużi pazjenti li jkollhom alanine aminotransferase (ALT) jew aspartate aminotransferase (AST) qabel il- kura > 3 darbiet il- limitu ta ’ fuq tan- normal (ULN) (ara sezzjonijiet 4. 3, 4. 4 u 4. 8).
2 Elderly (≥ 65 years) As metformin is excreted via the kidney, and elderly patients have a tendency to decreased renal function, elderly patients taking Icandra should have their renal function monitored regularly (see section 4.4).
2 Anzjani (≥ 65 sena) Peress illi metformin jitneħħa mill- kilwa, u pazjenti anzjani għandhom it- tendenza li jkollhom funzjoni renali mnaqsa, pazjenti anzjani li jkunu qed jieħdu Icandra għandu jkollhom il- funzjoni renali immonitorata b’ mod regolari (ara sezzjoni 4. 4).
Icandra has not been studied in patients older than 75 years.
Icandra ma kienx studjat f’ pazjenti li għandhom ’ l fuq minn 75 sena.
Therefore the use of Icandra is not recommended in this population.
Għalhekk l- użu ta ’ Icandra mhux rakkomandat f’ din il- popolazzjoni.
Paediatric population (< 18 years) Icandra is not recommended for use in children and adolescents due to a lack of data on safety and efficacy.
Popolazzjoni pedjatrika (< 18- il sena) Icandra mhux irrakkomandat għall- użu fit- tfal u adolexxenti peress li hemm nuqqas ta ’ informazzjoni dwar is- sigurtà u l- effikaċja.
General Icandra is not a substitute for insulin in insulin-requiring patients and should not be used in patients with type 1 diabetes.
Ġenerali Icandra mhux sostitut għall- insulina f’ pazjenti li jeħtieġu l- insulina u mgħandux jintuża f’ pazjenti b’ dijabete tat- tip 1.
Renal impairment As metformin is excreted by the kidney, serum creatinine concentrations should be monitored regularly:
3 Indeboliment renali Peress li metformin jitneħħa mill- kilwa, il- konċentrazzjonijiet tal- krejatinina fis- serum għandhom jiġu monitorati b’ mod regolari:
- at least two to four times a year in patients with serum creatinine levels at the upper limit of
- mill- anqas darbtejn sa ’ erba ’ darbiet fis- sena f’ pazjenti li jkollhom livelli ta ’ krejatinina fis -
normal and in elderly patients.
serum mal- livell ta ’ fuq tan- normal u f’ pazjenti anzjani.
3 Renal impairment in elderly patients is frequent and asymptomatic.
Indeboliment renali f’ pazjenti anzjani jseħħ ta ’ spiss u mingħajr sintomi.
Hepatic impairment Patients with hepatic impairment, including those with pre-treatment ALT or AST > 3x ULN, should not be treated with Icandra (see sections 4.2, 4.3 and 4.8).
Indeboliment tal- fwied Pazjenti b’ indeboliment epatik, inklużi pazjenti li jkollhom ALT jew AST qabel il- kura > 3 darbiet ULN, m’ għandhomx jiġu kkurati b’ Icandra (ara sezzjonijiet 4. 2, 4. 3 u 4. 8).
LFTs should be performed prior to the initiation of treatment with Icandra in order to know the patient’s baseline value.
It- testijiet tal- funzjoni tal- fwied għandhom isiru qabel ma tinbeda l- kura b’ Icandra sabiex ikun magħruf il- valur tal- linja bażi tal- pazjent.
Liver function should be monitored during treatment with Icandra at three-month intervals during the first year and periodically thereafter.
Il- funzjoni tal- fwied għandha tiġi monitorata waqt il- kura b’ Icandra f’ intervalli ta ’ tlett xhur fl- ewwel sena u darba kulltant minn hemm ’ l quddiem.
Should an increase in AST or in ALT of 3x ULN or greater persist, withdrawal of Icandra therapy is recommended.
Jekk iż- żieda fl- AST jew fl- ALT ta ’ 3 darbiet il- ULN jew akbar tippersisti, it- twaqqif tat- terapija b ’ Icandra huwa rakkomandat.
Patients who develop jaundice or other signs suggestive of liver dysfunction should discontinue Icandra.
Pazjenti li jiżviluppaw is - suffejra jew sinjali li jindikaw funzjoni anormali tal- fwied għandhom iwaqqfu Icandra.
Following withdrawal of treatment with Icandra and LFT normalisation, treatment with Icandra should not be re-initiated.
Wara t- twaqqif tal- kura b’ Icandra u LFT ikun ġie lura għan- normal, il- kura b’ Icandra mgħandhiex terġa tinbeda.
Metformin is contraindicated in patients with heart failure, therefore Icandra is contraindicated in this patient population (see section 4.3).
Metformin huwa kontra- indikat f’ pazjenti b’ insuffiċjenza tal- qalb, għalhekk Icandra huwa kontra - indikat f’ din il- popolazzjoni ta ’ pazjenti (ara sezzjoni 4. 3).
Surgery As Icandra contains metformin, the treatment should be discontinued 48 hours before elective surgery with general anaesthesia and should not usually be resumed earlier than 48 hours afterwards.
Kirurġija Peress li Icandra fih metformin, il- kura għandha titwaqqaf 48 siegħa qabel kirurġija li tkun ippjanata b’ loppju ġenerali u s- soltu m’ għandhiex terġa tinbeda qabel 48 siegħa wara.
Therefore, due to the metformin active substance, Icandra should be discontinued prior to, or at the time of, the test and not reinstituted until 48 hours afterwards, and only after renal function has been re-evaluated and found to be normal (see section 4.5).
Għalhekk, minħabba s- sustanza attiva metformin, Icandra għandu jitwaqqaf qabel, jew waqt, it- test u ma jerġax jinbeda sa ’ 48 siegħa wara, u biss f’ każ li l- funzjoni renali tkun reġgħet ġiet evalwata u misjuba normali (ara sezzjoni 4. 5).
There have been no formal interaction studies for Icandra.
Ma sarux studji dwar l- effett ta ’ medicini jew ta’ affarijiet oħra fuq l- effett farmaċewtiku ta ’ Icandra.
Metformin Combinations not recommended There is increased risk of lactic acidosis in acute alcohol intoxication (particularly in the case of fasting, malnutrition or hepatic insufficiency) due to the metformin active substance of Icandra (see section 4.4).
Metformin Kumbinazzjonijiet mhux rakkomandat Hemm riskju akbar ta ’ aċidożi lattika f’ intossikazzjoni akuta bl- alkoħol (l- aktar fil- każ ta ’ sawm, malnutrizzjoni jew insuffiċjenza tal- fwied) minħabba s- sustanza attiva metformin li hemm f ’ Icandra (ara sezzjoni 4. 4).
If necessary, the dosage of Icandra may need to be adjusted during concomitant therapy and on its discontinuation.
Jekk ikun hemm bżonn, id- dożaġġ ta ’ Icandra jista ’ jeħtieġ aġġustar meta tingħata terapija miegħu u meta titwaqqaf.
Angiotensin converting enzyme (ACE) inhibitors may decrease the blood glucose levels.
Impedituri ta ’ angiotensin converting enzyme (ACE) jistgħu jnaqqsu l- livelli tal- glucose fid- demm.
5 4.6 Pregnancy and lactation
5 4. 6 Tqala u Treddigħ
There are no adequate data from the use of Icandra in pregnant women.
M’ hemmx tagħrif biżżejjed dwar l- użu ta ’ Icandra waqt it- tqala.
For metformin, studies in animals have not shown reproductive toxicity.
Għal metformin, studji fuq bhejjem ma wrewx ħsara fuq is- sistema riproduttiva.
Icandra should not be used during pregnancy.
Icandra m’ għandux jintuża waqt it- tqala.
Due to both the potential risk of neonate hypoglycaemia related to metformin and the lack of human data with vildagliptin, Icandra should not be used during lactation (see section 4.3).
Kemm minħabba r- riskju potenzjali li t- tarbija tat- twelid jista ’ jkollha ipogliċemija minħabba metformin kif ukoll minħabba n- nuqqas ta ’ dejta fil- bniedem b’ vildagliptin, Icandra m’ għandux jintuża waqt it- treddigħ (ara sezzjoni 4. 3).
There have been no therapeutic clinical trials conducted with Icandra.
Ma sarux provi kliniċi terapewtiċi b’ Icandra.
However, bioequivalence of Icandra with co-administered vildagliptin and metformin has been demonstrated (see section 5.2).
Madankollu, il- bioekwivalenza ta’ Icandra meta ngħata flimkien ma ’ vildagliptin u metformin ġiet murija (ara sezzjoni 5. 2).
No data are available with regard to overdose of Icandra.
M’ hemmx dejta dwar doża eċċessiva b’ Icandra.
Icandra combines two antihyperglycaemic agents with complimentary mechanisms of action to improve glycaemic control in patients with type 2 diabetes: vildagliptin, a member of the islet enhancer class, and metformin hydrochloride, a member of the biguanide class.
Icandra jikkombina żewġ aġenti kontra l- ipergliċemija b’ mekkaniżmu ta ’ azzjoni kumplimentari sabiex jitjieb il- kontroll ta ’ pazjenti bid- dijabete tat- tip 2: vildagliptin, membru tal- klassi li jtejjeb l - islet, u metformin hydrochloride, membru tal- klassi biguanide.
9 Metformin may exert its glucose -lowering effect via three mechanisms:
9 Metformin jista ’ jeżerċita l- effett tiegħu li jnaqqas il- glucose permezz ta ’ tlett mekkaniżmi:
Icandra Absorption Bioequivalence has been demonstrated between Icandra at three dose strengths (50 mg/500 mg, 50 mg/850 mg and 50 mg/1000 mg) versus free combination of vildagliptin and metformin hydrochloride tablets at the corresponding doses.
Icandra Assorbiment Intweriet bioekwivalenza mejn Icandra fi tlett qawwiet ta ’ dożi (50 mg/ 500 mg, 50 mg/ 850 mg u 50 mg/ 1000 mg), kontra kombinazzjoni ħielsa ta ’ pilloli ta ’ vildagliptin u metformin hydrochloride bid- dożi li jikkorrispondu għalihom.
Food does not affect the extent and rate of absorption of vildagliptin from Icandra.
L- ikel ma jeffettwax il- grad u r- rata ta ’ assorbiment ta ’ vildagliptin minn Icandra.
The rate and extent of absorption of metformin from Icandra 50 mg/1000 mg were decreased when given with food as reflected by the decrease in Cmax by 26%, AUC by 7% and delayed Tmax (2.0 to 4.0 h).
Ir- rata u l- grad ta ’ assorbiment ta ’ metformin milIcandra 50 mg/ 1000 mg kienu mnaqqsa meta mogħtija ma ’ l- ikel bi tnaqqis fis- Cmax b’ 26%, AUC b’ 7% u Tmax ittardjat (2. 0 sa 4. 0 h).
The following statements reflect the pharmacokinetic properties of the individual active substances of Icandra.
Id- dikjarazzjonijiet li ġejjin jirriflettu il- kwalitajiet farmakokinetiċi tas- sustanzi attivi f’ Icandra.
10 Distribution The plasma protein binding of vildagliptin is low (9.3%) and vildagliptin distributes equally between plasma and red blood cells.
Distribuzzjoni Vildagliptin jorbot b’ mod dgħajjef mal- proteini tal- plażma (9. 3%) u vildagliptin jinfirex b’ mod ugwali bejn il- plażma u ċ- ċelluli ħomor tad- demm.
Biotransformation Metabolism is the major elimination pathway for vildagliptin in humans, accounting for 69% of the dose.
10 Biotrasformazzjoni Fil- bniedem il- metaboliżmu huwa l- mezz ewlieni li bih jitnehha vildagliptin, li jgħodd 69% tad- doża.
11 schedules, steady state plasma concentrations are reached within 24-48 h and are generally less than 1 µg/ml.
Bid- dożi ta ’ metformin tas- soltu u skedi ta ’ dożaġġi, il- konċentrazzjonijiet fil- plażma fi stat- fiss jintlaħqu fi żmien 24- 48 h u huma b’ mod ġenerali anqas minn 1 µg/ ml.
Food slightly delays and decreases the extent of the absorption of metformin.
11 L- ikel jittardja bi ftit u jnaqqas il- grad ta ’ assorbiment ta ’ metformin.
Animal studies of up to 13-week duration have been conducted with the combined substances in Icandra.
Studji f’ annimali li damu sa ’ 13- il ġimgħa saru bis- sustanzi kombinati f’ Icandra.
An increased incidence of mammary adenocarcinomas and haemangiosarcomas was observed with a no-effect dose of 500 mg/kg (59-fold human exposure) and
Żieda fl- adenokanċeromi tal- mammarji u haemangiosrcomas dehru b’ doża mingħajr effett ta ’ 500 mg/ kg (59 darba l- esponiment fil- bniedem) u 100 mg/ kg (16- il darba l - esponiment fil- bniedem), rispettivament.
The increased incidence of these tumours in mice is considered not to represent a significant risk to humans based on the lack of genotoxicity of vildagliptin and its principal metabolite, the occurrence of tumours only in one species, and the high systemic exposure ratios at which tumours were observed.
12 meqjusa li tirrapreżenta riskju sinifikanti għall- bnedmin ibbażat minn- nuqqas ta ’ ġenotossiċità ta ’ vildagliptin u l- metabolu ewlieni tiegħu, id- dehra tat- tumuri fi speċi waħda biss, u il- proporzonijiet sistemiċi għoljin li bihom dehru dawn it- tumuri.
In a 13-week toxicology study in cynomolgus monkeys, skin lesions have been recorded at doses ≥ 5 mg/kg/day.
Fi studju tossikoloġiku ta ’ 13- il ġimgħa f’ xadini cynomolgus, feriti fil- ġilda kienu reġistrati b’ dożi ta ’ ≥ 5 mg/ kg/ jum.
13 6.6 Special precautions for disposal
13 6. 6 Prekawzjonijiet speċjali li għandhom jittieħdu meta jintrema
Icandra 50 mg/1000 mg film-coated tablets
Icandra 50 mg/ 1000 mg pilloli miksijin b’ rita
Adults Based on the patient’s current dose of metformin, Icandra may be initiated at either the 50 mg/850 mg or 50 mg/1000 mg tablet strength twice daily, one tablet in the morning and the other in the evening.
Adulti Ibbażat fuq id- doża ta ’ metformin li jkun qed jieħu l- pazjent, Icandra jista ’ jinbeda b’ pillola ta ’ 50 mg/ 850 mg jew ta ’ 50 mg/ 1000 mg darbtejn kuljum, pillola waħda filgħodu u l- oħra filgħaxija.
Additional information on special populations Renal impairment Icandra should not be used in patients with creatinine clearance < 60 ml/min (see sections 4.3, 4.4 and 5.2).
Informazzjoni oħra fuq popolazzjonijiet speċjali Indeboliment renali Icandra m’ għandux jintuża f’ pazjenti bi tneħħija tal- krejatinina < 60 ml/ min (ara sezzjonijiet 4. 3, 4. 4 u 5. 2).
15 Elderly (≥ 65 years) As metformin is excreted via the kidney, and elderly patients have a tendency to decreased renal function, elderly patients taking Icandra should have their renal function monitored regularly (see section 4.4).
15 Anzjani (≥ 65 sena) Peress illi metformin jitneħħa mill- kilwa, u pazjenti anzjani għandhom it- tendenza li jkollhom funzjoni renali mnaqsa, pazjenti anzjani li jkunu qed jieħdu Icandra għandu jkollhom il- funzjoni renali immonitorata b’ mod regolari (ara sezzjoni 4. 4).
Renal impairment As metformin is excreted by the kidney, serum creatinine concentrations should be monitored regularly:
16 Indeboliment renali Peress li metformin jitneħħa mill- kilwa, il- konċentrazzjonijiet tal- krejatinina fis- serum għandhom jiġu monitorati b’ mod regolari:
16 Renal impairment in elderly patients is frequent and asymptomatic.
Indeboliment renali f’ pazjenti anzjani jseħħ ta ’ spiss u mingħajr sintomi.
Hepatic impairment Patients with hepatic impairment, including those with pre-treatment ALT or AST > 3x ULN, should not be treated with Icandra (see sections 4.2, 4.3 and 4.8).
Indeboliment tal- fwied Pazjenti b’ indeboliment epatiku, inklużi pazjenti li jkollhom ALT jew AST qabel il- kura > 3 darbiet ULN, m’ għandhomx jiġu kkurati b’ Icandra (ara sezzjonijiet 4. 2, 4. 3 u 4. 8).
18 4.6 Pregnancy and lactation
18 4. 6 Tqala u Treddigħ
22 Metformin may exert its glucose-lowering effect via three mechanisms:
22 Metformin jista ’ jeżerċita l- effett tiegħu li jnaqqas il- glucose permezz ta ’ tlett mekkaniżmi:
23 Distribution The plasma protein binding of vildagliptin is low (9.3%) and vildagliptin distributes equally between plasma and red blood cells.
Distribuzzjoni Vildagliptin jorbot b’ mod dgħajjef mal- proteini tal- plażma (9. 3%) u vildagliptin jinfirex b’ mod ugwali bejn il- plażma u ċ- ċelluli ħomor tad- demm.
Biotransformation Metabolism is the major elimination pathway for vildagliptin in humans, accounting for 69% of the dose.
23 Biotrasformazzjoni Fil- bniedem il- metaboliżmu huwa l- mezz ewlieni li bih jitnehha vildagliptin, li jgħodd 69% tad- doża.
24 schedules, steady state plasma concentrations are reached within 24-48 h and are generally less than 1 µg/ml.
Bid- dożi ta ’ metformin tas- soltu u skedi ta ’ dożaġġi, il- konċentrazzjonijiet fil- plażma fi stat- fiss jintlaħqu fi żmien 24- 48 h u huma b’ mod ġenerali anqas minn 1 µg/ ml.
Food slightly delays and decreases the extent of the absorption of metformin.
24 L- ikel jittardja bi ftit u jnaqqas il- grad ta ’ assorbiment ta ’ metformin.
The increased incidence of these tumours in mice is considered not to represent a significant risk to humans based on the lack of genotoxicity of vildagliptin and its principal metabolite, the occurrence of tumours only in one species, and the high systemic exposure ratios at which tumours were observed.
25 meqjusa li tirrapreżenta riskju sinifikanti għall- bnedmin ibbażat minn- nuqqas ta ’ ġenotossiċità ta ’ vildagliptin u l- metabolu ewlieni tiegħu, id- dehra tat- tumuri fi speċi waħda biss, u il- proporzonijiet sistemiċi għoljin li bihom dehru dawn it- tumuri.
26 6.6 Special precautions for disposal
26 6. 6 Prekawzjonijiet speċjali li għandhom jittieħdu meta jintrema
Pharmacovigilance system The MAH must ensure that the system of pharmacovigilance, as described in version 3.0 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.
Sistema ta ’ Farmakoviilanza L- MAH għandu jaċċerta ruħu li s- sistema ta ’ farmakoviġilanza, hekk kif deskritta f’ verżjoni 3. 0 ippreżentata f’ Modulu 1. 8. 1. ta ’ l- Applikazzjoni ta ’ L- Awtorizzazzjoni għat- Tqegħid fis- Suq, tkun imwaqqfa u taħdem qabel u waqt li l- prodott ikun fuq is- suq.
PSURs The PSUR cycle of Icandra will correspond to the one attributed to the cross-referred product, Eucreas, until otherwise specified.
PSURs Ic- ciklu ta ’ PSUR ta ’ Icandra ħa jikkorrispondi ghal dak attribwit ghal prodott li ghalih qed issir referenza, Eucreas, sakemm jigi speċifikat mod ieħor.
Icandra 50 mg/850 mg film-coated tablets vildagliptin/metformin hydrochloride
Icandra 50 mg/ 850 mg pilloli miksijin b’ rita vildagliptin/ metformin hydrochloride
Icandra 50 mg/1000 mg film-coated tablets vildagliptin/metformin hydrochloride
Icandra 50 mg/ 1000 mg pilloli miksijin b’ rita vildagliptin/ metformin hydrochloride
Icandra 50 mg/850 mg film-coated tablets Icandra 50 mg/1000 mg film-coated tablets
Icandra 50 mg/ 850 mg pilloli miksijin b’ rita Icandra 50 mg/ 1000 mg pilloli miksijin b’ rita
What Icandra is and what it is used for 2.
X’ inhu Icandra u għalxiex jintuża 2.
Before you take Icandra 3.
Qabel ma tieħu Icandra 3.
How to take Icandra 4.
Kif għandek tieħu Icandra 4.
How to store Icandra 6.
Kif taħżen Icandra 6.
WHAT ICANDRA IS AND WHAT IT IS USED FOR
X’ INHU ICANDRA U GĦALXIEX JINTUŻA
The active substances of Icandra belong to a group of medicines called “oral antidiabetics”.
Is- sustanzi attivi ta ’ Icandra jagħmlu parti minn grupp ta ’ mediċini li jissejħu “ antidijabetiċi orali ”.
Icandra is used to treat patients with type 2 diabetes.
Icandra jintuża għall- kura ta ’ pazjenti bid- dijabete tat- tip 2.
Icandra contains two active substances called vildagliptin and metformin.
Icandra fih żewġ sustanzi attivi li jissejħu vildagliptin u metformin.
BEFORE YOU TAKE ICANDRA
QABEL MA TIEĦU ICANDRA
Do not take Icandra
Tieħux Icandra
Icandra (listed in section 6).
oħra ta ’ Icandra (elenkati f’ sezzjoni 6).
If you think you may be allergic to any of these, talk to your doctor before taking Icandra.
Jekk taħseb li tista ’ tkun allerġiku/ a għal kwalunkwe wieħed minn dawn, tkellem mat- tabib tiegħek qabel tieħu Icandra.
Please also see information about this in section “Take special care with Icandra”.
Jekk jogħġbok ara wkoll l- informazzjoni fuq dan fis- sezzjoni “ Oqgħod attent ħafna b’ Icandra ”.
Take special care with Icandra Stop taking this medicine and talk to your doctor if you experience one or more of the following symptoms which may be related to a condition called “lactic acidosis”:
Oqgħod attent ħafna b’ Icandra Tibqax tieħu din il- mediċina u kellem lit- tabib tiegħek jekk tħoss wieħed jew aktar mis- sintomi li ġejjin li jistgħu jkunu relatati ma ’ kundizzjoni imsejjħa “ aċidożi lattika ”:
If you have previously taken Galvus (vildagliptin) or Icandra but had to stop taking it because of side effects (liver disease), you should not take Icandra again.
Jekk xi darba hadt Galvus (vildagliptin) jew Icandra iżda kellek twaqqfu minħabba l- effetti sekondarji (mard tal- fwied), m’ għandekx terġa tieħu Icandra mill- ġdid.
You are also advised to pay particular attention to new onset of blisters or ulcers while taking Icandra.
Int konsiljat ukoll li toqgħod attent b’ mod partikolari għal xi nfatet jew ulċeri li jistgħu joħorġu waqt li tkun qed tieħu Icandra.