qanastek/EMEA-V3 huggingface dataset:
Starlix should not be used in people who may be hypersensitive (allergic) to nateglinide or any of the other ingredients, who have type 1 diabetes or a severe liver problem, or who have diabetic ketoacidosis (a serious complication of diabetes).
Starlix m’ għandux jintuża minn persuni li huma allerġiċi għal nateglinide jew għal xi sustanzi oħra tiegħu, li jkollhom id- dijabete ta ’ l- ewwel tip jew problema severa fil- fwied, jew li jkollhom ketoaċidożi dijabetika (kumplikazzjoni serja tad- dijabete).
Its use is not recommended in pregnancy or while breast feeding.
L- użu tiegħu mhux rakkomandat fit- tqala jew waqt it- treddigħ.
Starlix doses might also need to be adjusted when given with some medicines used in heart conditions, to treat pain, to treat asthma, and other conditions.
Id- doża ta ’ Starlix tista ’ wkoll tiġi aġġustata meta tingħata ma ’ xi mediċini użati għall- kundizzjonijiet tal- qalb, biex jittrattaw l- uġigħ, biex jittrattaw l- ażma, u kundizzjonijiet oħra.
The full list is available in the Package Leaflet.
Il - lista sħiħa tinsab fil- Fuljett ta ’ Tagħrif.
Why has Starlix been approved?
Għaliex ġie approvat Starlix?
The Committee for Medicinal products for Human Use (CHMP) decided that Starlix’ s benefits are greater than its risks for the treatment of type 2 diabetes, in combination with metformin, in patients who are not controlled despite receiving the maximum daily dose of metformin.
Il- Kumitat għall- Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) iddeċieda li l- benefiċċji ta ’ Starlix huma ikbar mir- riskji tiegħu fit- trattament tad- dijabete tat- tieni tip, flimkien ma ’ metformin, f’ pazjenti li ma jkunux ikkontrollati minkejja li jkunu qed jingħataw id- doża massima ta ’ metformin.
The Committee recommended that Starlix be given marketing authorisation.
Il- Kumitat irrakkomanda li Starlix jingħata l- awtorizzazzjoni għat- tqegħid fis- suq.
Other information about Starlix:
Tagħrif ieħor dwar Starlix:
The European Commission granted a marketing authorisation valid throughout the European Union for Starlix to Novartis Europharm Limited on 3 April 2001.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fis- suq għal Starlix lil Novartis Europharm Limited fit- 3 ta ’ April 2001.
The marketing authorisation was renewed on 3 April 2006.
L- awtorizzazzjoni għat- tqegħid fis- suq ġiet imġedda fit- 3 ta ’ April 2006.
The full EPAR for Starlix is available here.
L- EPAR sħiħ għal Starlix huwa disponibbli minn hawnhekk.
EU Number EU/ 1/ 01/ 174/ 001 EU/ 1/ 01/ 174/ 002 EU/ 1/ 01/ 174/ 003 EU/ 1/ 01/ 174/ 004 EU/ 1/ 01/ 174/ 005 EU/ 1/ 01/ 174/ 006 EU/ 1/ 01/ 174/ 007 EU/ 1/ 01/ 174/ 008 EU/ 1/ 01/ 174/ 009 EU/ 1/ 01/ 174/ 010 EU/ 1/ 01/ 174/ 011 EU/ 1/ 01/ 174/ 012 EU/ 1/ 01/ 174/ 013 EU/ 1/ 01/ 174/ 014 EU/ 1/ 01/ 174/ 015 EU/ 1/ 01/ 174/ 016 EU/ 1/ 01/ 174/ 017 EU/ 1/ 01/ 174/ 018 EU/ 1/ 01/ 174/ 019 EU/ 1/ 01/ 174/ 020 EU/ 1/ 01/ 174/ 021
Numru ta ’ l- EU EU/ 1/ 01/ 174/ 001 EU/ 1/ 01/ 174/ 002 EU/ 1/ 01/ 174/ 003 EU/ 1/ 01/ 174/ 004 EU/ 1/ 01/ 174/ 005 EU/ 1/ 01/ 174/ 006 EU/ 1/ 01/ 174/ 007 EU/ 1/ 01/ 174/ 008 EU/ 1/ 01/ 174/ 009 EU/ 1/ 01/ 174/ 010 EU/ 1/ 01/ 174/ 011 EU/ 1/ 01/ 174/ 012 EU/ 1/ 01/ 174/ 013 EU/ 1/ 01/ 174/ 014 EU/ 1/ 01/ 174/ 015 EU/ 1/ 01/ 174/ 016 EU/ 1/ 01/ 174/ 017 EU/ 1/ 01/ 174/ 018 EU/ 1/ 01/ 174/ 019 EU/ 1/ 01/ 174/ 020 EU/ 1/ 01/ 174/ 021
Invented name Starlix Starlix Starlix Starlix Starlix Starlix Starlix Starlix Starlix Starlix Starlix Starlix Starlix Starlix Starlix Starlix Starlix Starlix Starlix Starlix Starlix
Isem inventat Starlix Starlix Starlix Starlix Starlix Starlix Starlix Starlix Starlix Starlix Starlix Starlix Starlix Starlix Starlix Starlix Starlix Starlix Starlix Starlix Starlix
Strength 60 mg 60 mg 60 mg 60 mg 60 mg 60 mg 60 mg 120 mg 120 mg 120 mg 120 mg 120 mg 120 mg 120 mg 180 mg 180 mg 180 mg 180 mg 180 mg 180 mg 180 mg
Qawwa 60 mg 60 mg 60 mg 60 mg 60 mg 60 mg 60 mg 120 mg 120 mg 120 mg 120 mg 120 mg 120 mg 120 mg 180 mg 180 mg 180 mg 180 mg 180 mg 180 mg 180 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 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 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 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 Użu orali Użu orali Użu orali
Packaging blister (PVC/ PE/ PVDC/ Alu) blister (PVC/ PE/ PVDC/ Alu) blister (PVC/ PE/ PVDC/ Alu) blister (PVC/ PE/ PVDC/ Alu) blister (PVC/ PE/ PVDC/ Alu) blister (PVC/ PE/ PVDC/ Alu) blister (PVC/ PE/ PVDC/ Alu) blister (PVC/ PE/ PVDC/ Alu) blister (PVC/ PE/ PVDC/ Alu) blister (PVC/ PE/ PVDC/ Alu) blister (PVC/ PE/ PVDC/ Alu) blister (PVC/ PE/ PVDC/ Alu) blister (PVC/ PE/ PVDC/ Alu) blister (PVC/ PE/ PVDC/ Alu) blister (PVC/ PE/ PVDC/ Alu) blister (PVC/ PE/ PVDC/ Alu) blister (PVC/ PE/ PVDC/ Alu) blister (PVC/ PE/ PVDC/ Alu) blister (PVC/ PE/ PVDC/ Alu) blister (PVC/ PE/ PVDC/ Alu) blister (PVC/ PE/ PVDC/ Alu)
Il- pakkett folja (PVC/ PE/ PVDC/ Alu) folja (PVC/ PE/ PVDC/ Alu) folja (PVC/ PE/ PVDC/ Alu) folja (PVC/ PE/ PVDC/ Alu) folja (PVC/ PE/ PVDC/ Alu) folja (PVC/ PE/ PVDC/ Alu) folja (PVC/ PE/ PVDC/ Alu) folja (PVC/ PE/ PVDC/ Alu) folja (PVC/ PE/ PVDC/ Alu) folja (PVC/ PE/ PVDC/ Alu) folja (PVC/ PE/ PVDC/ Alu) folja (PVC/ PE/ PVDC/ Alu) folja (PVC/ PE/ PVDC/ Alu) folja (PVC/ PE/ PVDC/ Alu) folja (PVC/ PE/ PVDC/ Alu) folja (PVC/ PE/ PVDC/ Alu) folja (PVC/ PE/ PVDC/ Alu) folja (PVC/ PE/ PVDC/ Alu) folja (PVC/ PE/ PVDC/ Alu) folja (PVC/ PE/ PVDC/ Alu) folja (PVC/ PE/ PVDC/ Alu)
Package size 12 24 30 60 84 120 360 12 24 30 60 84 120 360 12 24 30 60 84 120 360
Daqs tal- pakkett 12 24 30 60 84 120 360 12 24 30 60 84 120 360 12 24 30 60 84 120 360
STARLIX 60 mg film-coated tablets
STARLIX 60 mg pilloli miksijin b’ rita
Each film-coated tablet contains 60 mg nateglinide.
Kull pillola miksija b’ rita fiha 60 mg nateglinide.
Lactose monohydrate:
Lactose monohydrate:
141.5 mg per tablet.
141. 5 mg għal kull pillola.
60 mg pink, round, bevelled-edge tablets with “ STARLIX” marked on one side and “ 60” on the other.
Pilloli b’ 60 mg, roża, tondi, b’ xifer imżerżaq b ’ “ STARLIX ” immarkat fuq naħa u “ 60 ” fuq l- oħra.
Nateglinide is indicated for combination therapy with metformin in type 2 diabetic patients inadequately controlled despite a maximally tolerated dose of metformin alone.
Nateglinide huwa indikat għal terapija kkombinata ma ’ metformin f’ pazjenti b’ dijabete tat- tip 2 li minkejja li jkunu qed jieħdu d- doża massima ta ’ metformin waħdu li jistgħu jifilħu ma jkunux kontrollati kif jixraq.
Nateglinide should be taken within 1 to 30 minutes before meals (usually breakfast, lunch and dinner).
Nateglinide għandu jittieħed fi żmien 1 sa 30 minuta qabel l- ikel (normalment mal- kolazzjon, l- ikla ta ’ nofsinhar u l- ikla ta ’ filgħaxija).
The dosage of nateglinide should be determined by the physician according to the patient’ s requirements.
Id- dożaġġ ta ’ nateglinide għandu jkun deċiż mit- tabib skond il- bżonnijiet tal- pazjent.
The recommended starting dose is 60 mg three times daily before meals, particularly in patients who are near goal HbA1c.
Id- doża tal- bidu rakkomandata hi 60 mg tlett darbiet kuljum qabel l- ikel, l- aktar f’ dawk il- pazjenti li jkunu qrib l- HbA1c mixtieq.
This may be increased to 120 mg three times daily.
Din tista ’ tiżdied għal 120 mg tlett darbiet kuljum.
Since the primary therapeutic effect of Starlix is to reduce mealtime glucose, (a contributor to HbA1c), the therapeutic response to Starlix may also be monitored with 1– 2 hour post-meal glucose.
Tibdil fid- doża għandu jkun ibbażat fuq il- kejl perjodiku tal- ħemoglobina glikożilata (HbA1c) Minħabba illi l- effett ewlieni ta ’ Starlix huwa li jnaqqas glucose li jiġi mill- ikel, (li jikkawża HbA1c), ir- rispons terapewtiku għal Starlix jista ’ jkun monitorat mill- ammont ta ’ glucose li jkun hemm bejn siegħa- sagħtejn wara l- ikel.
The recommended maximum daily dose is 180 mg three times daily to be taken before the three main meals.
L- ogħla doża ta ’ kuljum rakkomandata hi ta ’ 180 mg tlett darbiet kuljum meħudha qabel it- tlett ikliet prinċipali.
Specific patient groups Elderly The clinical experience in patients over 75 years of age is limited.
Gruppi speċifiċi ta ’ pazjenti L- Anzjani L- esperjenza klinika f’ pazjenti minn 75 sena ’ l fuq hija limitata.
Children and adolescents There are no data available on the use of nateglinide in patients under 18 years of age, and therefore its use in this age group is not recommended.
Tfal u Adoloxxenti M’ hemmx tagħrif dwar l- użu ta ’ nateglinide f’ pazjenti taħt it- 18- il sena, u għalhekk l- użu f’ dan il - grupp ta ’ etajiet mhux rakkomandat.
Patients with hepatic impairment No dose adjustment is necessary for patients with mild to moderate hepatic impairment.
2 M’ hemmx bżonn ta ’ tibdil fid- doża għal pazjenti b’ indeboliment tal- fwied ħafif għal moderat.
As patients with severe liver disease were not studied, nateglinide is contraindicated in this group.
Peres li ma kienux studjati pazjenti li jkollhom indeboliment tal- fwied sever, nateglinide huwa kontra- indikat f’ dan il- grupp.
2 Patients with renal impairment No dose adjustment is necessary in patients with mild to moderate renal impairment.
Pazjenti b’ impediment renali M’ hemmx bżonn ta ’ tibdil fid- doża għal pazjenti b’ indeboliment renali ħafif għal moderat.
Although there is a 49% decrease in Cmax of nateglinide in dialysis patients, the systemic availability and half-life in diabetic subjects with moderate to severe renal insufficiency (creatinine clearance 15– 50 ml/ min) was comparable between renal subjects requiring haemodialysis and healthy subjects.
Għalkemm hemm tnaqqis ta ’ 49% fis - Cmax ta ’ nateglinide f’ pazjenti li jkunu fuq id- dijaliżi, id - disponibilità sistemika u l- half- life f’ individwi dijabetiċi b ’ insuffiċjenza renali (tneħħija tal - krejatinina 15– 50 ml/ min) kien jitqabbel bejn individwi renali li kellhomm bżonn id- dijaliżi tad- demm u individwi b’ saħħithom.
Although safety was not compromised in this population dose adjustment may be required in view of low Cmax.
Għalkemm is- sigurtà ma kienitx kompromessa f’ din il- popolazzjoni għandu mnejn ikun hemm bżonn tibdil fid- doża minnħabba tnaqqis tas- Cmax.
Others In debilitated or malnourished patients the initial and maintenance dosage should be conservative and careful titration is required to avoid hypoglycaemic reactions.
Oħrajn F’ pazjenti indebboliti jew li qed ibatu minn- dieta ħażina d- dożaġġ tal- bidu u ta ’ manteniment għandu jkun konservattiv u jiżdied b’ kawtela biex tevita reazzjonijiet ipogliċemiċi.
Starlix is contraindicated in patients with: • Hypersensitivity to the active substance or to any of the excipients • Type 1 diabetes (insulin-dependent diabetes mellitus, C-peptide negative) • Diabetic ketoacidosis, with or without coma • Pregnancy and breast-feeding (see section 4.6) • Severe hepatic impairment
Starlix huwa kontra- indikat f’ pazjenti b ’: • Sensittività eċċessiva għas- sustanza attiva jew għal xi sustanzi mhux attivi. • Dijabete Tip 1 (Dijabete mellitus dipendenti fuq l- insulina, C- peptajd negattiv) • Ketoaċidożi tad- dijabete, b’ koma jew mingħajrha • Tqala u treddigħ (ara sezzjoni 4. 6) • Impediment epatiku sever
General Nateglinide should not be used in monotherapy.
Ġenerali Nateglinide m’ għandux jintuża waħdu.
Like other insulin secretagogues, nateglinide is capable of producing hypoglycaemia.
Bħal sekretagogi ta ’ l- insulina oħrajn, nateglinide għandu l- ħila li jikkawża ipogliċemija.
Hypoglycaemia has been observed in patients with type 2 diabetes on diet and exercise, and in those treated with oral antidiabetic agents (see section 4.8).
L- ipogliċemija ġiet osservata f’ pazjenti b’ dijabete tip 2 li kienu fuq dieta u li kienu qed jagħmlu l - eżerċizzji, u f ’ dawk li kienu ikkurati b’ aġenti antidijabetiċi li jittieħdu mill- ħalq (ara sezzjoni 4. 8).
Elderly, malnourished patients and those with adrenal or pituitary insufficiency or severe renal impairment are more susceptible to the glucose- lowering effect of these treatments.
Pazjenti anzjani fuq dieta ħażina u dawk b’ insuffiċjenza adrenali jew pitwitarja jew indeboliment renali sever ikollhom aktar xeħta li jseħħulhom l- effetti ta ’ tnaqqis ta ’ glucose ta ’ dawn il- kuri.
The risk of hypoglycaemia in type 2 diabetic patients may be increased by strenuous physical exercise, or ingestion of alcohol.
Ir - riskju ta ’ ipogliċemija f’ pazjenti b’ dijabete tip 2 tista ’ tizdied meta jgħamlu eżerċizzji fiżiċi ta ’ stress, jew jieħdu alkoħol.
Symptoms of hypoglycaemia (unconfirmed by blood glucose levels) were observed in patients whose baseline HbA1c was close to the therapeutic target (HbA1c < 7.5%).
Sintomi ta ’ ipogliċemija (mhux ikkonfermati bil- livelli ta ’ glucose fid- demm) kienu osservati f’ pazjenti li kellhom il- linja bażi ta ’ HbA1c viċin għall- livell terapewtiku mixtieq (HbA1C < 7. 5%).
Combination with metformin is associated with an increased risk of hypoglycaemia compared to monotherapy.
Il- kombinazzjoni ma ’ metformin ġiet assoċjata ma ’ riskju akbar ta ’ ipogliċemija meta imqabbel ma ’ monoterapija.
Hypoglycaemia may be difficult to recognise in subjects receiving beta blockers.
L- ipogliċemija tista ’ tkun diffiċli biex tagħrafha f’ individwi li qed jirċievu l- imblokkaturi beta.
When a patient stabilised on any oral hypoglycaemic agent is exposed to stress such as fever, trauma, infection or surgery, a loss of glycaemic control may occur.
Meta pazjent li jkun stabilizzat fuq aġenti ipogliċemiċi li jittieħdu mill- ħalq ikun esponut għal stress bħal deni, trawma, infezzjoni jew kirurġija, jista ’ jseħħ telf tal- kontroll gliċemiku.
At such times, it may be necessary to discontinue oral hypoglycaemic treatment and replace it with insulin on a temporary basis.
Fi żminijiet bħall - dawn jista ’ jkun hemm bżonn li titwaqqaf il- kura b’ antidijabetiċi li jittieħdu mill- ħalq u tiġi mibdula b’ insulina fuq bażi temporanja.
Starlix contains lactose monohydrate.
Starlix fih lactose monohydrate.
Patients with rare hereditary problems of galactose intolerance, of the Lapp lactase deficiency or of glucose-galactose malabsorption should not take this medicine.
Pazjenti li għandhom problemi ereditarji ta ’ intolleranza għal galactose, tad- defiċjenza ta ’ Lapp lactase jew ta ’ malassorbiment ta ’ glucose- galactose m’ għandhomx jieħdu din il- mediċina.
Specific patient groups Nateglinide should be used with caution in patients with moderate hepatic impairment.
3 Gruppi speċifiċi ta ’ pazjenti Nateglinide għandu jintuża b’ attenzjoni f’ pazjenti b’ indeboliment epatiku moderat.
No clinical studies have been conducted in patients with severe hepatic impairment or children and adolescents.
Ma saru l- ebda studji kliniċi f’ pazjenti b’ indeboliment epatiku sever jew tfal u adolexxenti.
Treatment is therefore not recommended in these patient groups.
Għalhekk il- kura mhijiex rakkomandata f’ dawn il- gruppi ta ’ pazjenti.
A number of medicinal products influence glucose metabolism and possible interactions should therefore be taken into account by the physician:
Numru ta ’ prodotti mediċinali jistgħu jeffettwaw il- metaboliżmu ta ’ glucose u għalhekk l - interazzjonijiet possibli għandhom jiġu meqjusa mit- tabib.
The following agents may enhance the hypoglycaemic effect of nateglinide: angiotensin-converting enzyme inhibitors (ACEI).
Dawn l- aġenti li jmiss jistgħu iżidu l- effett ipogliċemiku ta ’ nateglinide: impedituri ta ’ l- enzima tal - konverżjoni ta ’ angiotensin (ACEI).
The following agents may reduce the hypoglycaemic effect of nateglinide: diuretics, corticosteroids, and beta2 agonists.
Dawn l- aġenti li jmiss jistgħu jnaqqsu l- effett ipogliċemiku ta ’ nateglinide: dijuretiċi, kortikosterojdi, u agonisti beta2.
When these medicinal products are administered to or withdrawn from patients receiving nateglinide, the patient should be observed closely for changes in glycaemic control.
Meta dawn il- prodotti mediċinali jingħataw jew jitwaqqfu f’ pazjenti li qed jieħdu nateglinide, il - pazjent għandu jiġi osservat mill- qrib għal tibdil fil- kontroll gliċemiku.
Data available from both in vitro and in vivo experiments indicate that nateglinide is predominantly metabolised by CYP2C9 with involvement of CYP3A4 to a smaller extent.
Tagħrif disponibbli kemm in vitro kif ukoll in vivo jindikaw li nateglinide jiġi metaboliżżat l- aktar minn CYP2C9 b’ involviment minuri ta ’ CYP3A4.
In an interaction trial with sulfinpyrazone, a CYP2C9 inhibitor, a modest increase in nateglinide AUC (~28%) was observed in healthy volunteers, with no changes in the mean Cmax and elimination half-life.
Fi studju ta ’ interazzjoni ma ’ sulfinpyrazone, impeditur ta ’ CYP2C9, ġiet osservata żieda żgħira (28%) f’ voluntiera b’ saħħithom fl- AUC ta ’ nateglinide, bl- ebda tibdil fil- medja tas- Cmax u l- half- life ta ’ l- eliminazzjoni.
A more prolonged effect and possibly a risk of hypoglycaemia cannot be excluded in patients when nateglinide is co-administered with CYP2C9 inhibitors.
Effett imtawwal u possibilment riskju ta ’ ipogliċemija ma jistgħux jiġu esklużi meta nateglinide jingħata ma ’ impedituri CYP2C9.
Particular caution is recommended when nateglinide is co-administered with other more potent inhibitors of CYP2C9, e. g. fluconazole or gemfibrozil, or in patients known to be poor metabolisers for CYP2C9.
L- attenzjoni hija rakkomandata b’ mod partikolari meta nateglinide jingħata flimkien ma ’ impedituri CYP2C9 aktar qawwija, eż. fluconazole u gemfibrizol, jew f’ pazjenti magħrufa bħala metabolizzaturi dgħajfa ta ’ CYP2C9.
Interaction studies with a 3A4 inhibitor have not been carried out in vivo.
Studji ta ’ interazzjoni b ’ impeditur 3A4 in vivo ma sarux.
In vivo, nateglinide has no clinically relevant effect on the pharmacokinetics of medicinal products metabolised by CYP2C9 and CYP3A4.
In vivo, nateglinide ma kellu l- ebda effett kliniku sinifikanti fuq il- farmakokinetiċi ta ’ prodotti mediċinali metabolizzati minn CYP2C9 u CYP3A4.
The pharmacokinetics of warfarin (a substrate for CYP3A4 and CYP2C9), diclofenac (a substrate for CYP2C9), and digoxin were unaffected by coadministration with nateglinide.
Il- farmakokinteċi ta ’ warfarin (sottostrat għal CYP3A4 u CYP2C9), diclofenac (sottostrat għal CYP2C9), u digoxin ma kienux effettwati meta ingħataw ma ’ nateglinide.
Conversely, these medicinal products had no effect on the pharmacokinetics of nateglinide.
Bil- kontra, dawn il- prodotti mediċinali ma kellhom l- ebda effett fuq il - farmakokinetiċi ta ’ nateglinide.
Thus, no dosage adjustment is required for digoxin, warfarin or other drugs that are CYP2C9 or CYP3A4 substrates upon coadministration with Starlix.
Għalhekk, m’ hemmx bżonn ta ’ tibdil fid- doża għal digoxin, warfarin u mediċini oħra li huma sottostrati ta ’ CYP 2C9 u CYP 3A4 meta jingħataw ma ’ Starlix.
Similarly, there was no clinically significant pharmacokinetic interaction of Starlix with other oral antidiabetic agents such as metformin or glibenclamide.
Bl- istess modd ma kellha l- ebda effett kliniku sinifikanti l- interazzjoni farmakokinetika ta ’ Starlix ma ’ aġenti antidijabetici li jittieħdu mill- ħalq bħal metformin jew glibenclamide.
Nateglinide has shown a low potential for protein displacement in in vitro studies.
Nateglinide wera li ma tantx għandu ħila li jisposta l- proteina fi studji in vitro.
Studies in animals have shown developmental toxicity (see section 5.3).
Studji fuq bhejjem urew ħsara fuq is- sistema ta ’ l- iżvillup (ara sezzjoni 5. 3).
There is no experience in pregnant women, therefore the safety of Starlix in pregnant women cannot be assessed.
M’ hemm l- ebda esperjenza f’ nisa waqt it- tqala, għalhekk is- sigurta ’ ta ’ Starlix waqt it- tqala ma tistax tiġi stmata.
Starlix, like other oral antidiabetic agents, is not recommended for use in pregnancy.
Starlix, bħal aġenti ipogliċemiċi oħra li jittieħdu mill- ħalq, mhuwiex rakkomandat għall - użu waqt it- tqala.
Nateglinide is excreted in the milk following a peroral dose to lactating rats.
Nateglinide joħroġ mal- ħalib wara doża li ttieħed mill- ħalq f’ firien li qed ireddgħu.
Although it is not known whether nateglinide is excreted in human milk, the potential for hypoglycaemia in breast-fed infants may exist and therefore nateglinide should not be used in lactating women.
Għalkemm mhux magħruf jekk nateglinide joħroġx fil- ħalib tas- sider, tista ’ sseħħ ipogliċemija fi trabi li qed ireddgħu u għalhekk nateglinide m’ għandux jintuża f’ nisa li qed ireddgħu.
Patients should be advised to take precautions to avoid hypoglycaemia whilst driving or operating machinery.
Pazjenti għandhom ikunu avvżati biex jieħdu l- prekawzjonijiet biex jevitaw ipogliċemija waqt li jkunu qed isuqu jew iħaddmu magni.
This is particularly important in those who have reduced or absent awareness of the warning signs of hypoglycaemia or have frequent episodes of hypoglycaemia.
Dan huwa l- aktar importanti f’ dawk li ma tantx iħossu jew ma jħossux is- sinjali ta ’ twissija ta ’ ipogliċemija jew li għandhom episodji frekwenti ta ’ ipogliċemija.
The advisability of driving should be considered in these circumstances.
Għndu jittieħed parir dwar is- sewqan f’ dawn iċ- ċirkustanzi.
Based on the experience with nateglinide and with other hypoglycaemic agents, the following adverse reactions have been seen.
Mill- esperjenza b’ nateglinide u aġenti ipogliċemiċi oħra li jittieħdu mill- ħalq, dehru l- effetti avversi li ġejjin.
Frequencies are defined as: common (> 1/ 100 ,< 1/10); uncommon (> 1/1 ,000, < 1/100); rare (> 1/10,000, < 1/ 1,000); very rare (< 1/10 ,000).
Il- frekwenzi huma definiti bħala: komuni (> 1/ 100, < 1/ 10); mhux komuni (> 1/ 1, 000, < 1/ 100); rari (> 1/ 10, 000, < 1/ 1, 000); rari ħafna (< 1/ 10, 000).
Hypoglycaemia As with other antidiabetic agents, symptoms suggestive of hypoglycaemia have been observed after administration of nateglinide.
Ipogliċemija Bħal fil- każ ta ’ aġenti antidiabetiċi oħra, sintomi li jindikaw ipogliċemija kienu osservati wara li ngħata nateglinide.
These symptoms included sweating, trembling, dizziness, increased appetite, palpitations, nausea, fatigue, and weakness.
Dawn is- sintomi kienu jinkludu għaraq, rogħda, sturdament, żieda fl- aptit, palpitazzjonijiet, tqallih, għeja, u dgħjufija.
These were generally mild in nature and easily handled by intake of carbohydrates when necessary.
Dawn kienu ġeneralment ta ’ natura ħafifa u kontrollati bla tbatija billi ittieħdu karboidrati meta kien hemm bżonn.
In completed clinical trials, symptoms of hypoglycaemia were reported in 10.4% with nateglinide monotherapy, 14.5% with nateglinide+metformin combination, 6.9% with metformin alone, 19.8% with glibenclamide alone, and 4.1% with placebo.
Fi provi kliniċi li ntemmu, sintomi ta ’ ipogliċemija kienu irrapurtati f’ 10. 4% b’ monoterapija b’ nateglinide, 14. 5% b’ taħlita ta ’ nateglinide+metformin, 6. 9% b’ metformin waħdu, 19. 8% b’ glibenclamide waħdu, u 4. 1% bil - plaċebo.
Immune system disorders Rare:
Disturbi fis- sistema immuni Rari:
Hypersensitivity reactions such as rash, itching and urticaria.
Sensittività eċċessiva bħal raxx, ħakk u urtikarja.
Symptoms suggestive of hypoglycaemia.
Sintomi li jindikaw ipogliċemija.
Gatrointestinal disorders Common:
Disturbi gastro- intestinali Komuni:
Uncommon:
Uġigħ addominali, dijarea, dispepsja, tqallih Mhux komuni:
Vomiting.
Rimettar
Elevations in liver enzymes.
Żieda fl- enzimi tal- fwied.
Other events Other adverse events observed in clinical studies were of a similar incidence in Starlix-treated and placebo-treated patients.
Każijiet oħra Każijiet avversi oħrajn osservati fi studji kliniċi kienu ta ’ inċidenza simili f’ pazjenti ikkurati/ ittratati bi Starlix u f’ pazjenti kkurati bil- plaċebo.
Post-marketing data revealed very rare cases of erythema multiforme.
Tagħrif ta ’ wara t- tqegħid fis- suq wera każijiet rari ħafna ta ’ erythema multiforme.
In a clinical study in patients, Starlix was administered in increasing doses up to 720 mg a day for 7 days and was well tolerated.
Fi studju kliniku, Starlix ingħata lill- pazjenti b’ dożi li kienu miżjuda sa 720 mg kuljum għal 7 ijiem u kienu tollerati sew.
There is no experience of an overdose of Starlix in clinical trials.
L- ebda każ ta ’ doża eċċessiva ta ’ Starlix ma ġie rrapurtat fi studji kliniċi.
However, an overdose may result in an exaggerated glucose-lowering effect, with the development of hypoglycaemic symptoms.
Iżda doża eċċessiva tista ’ tirriżulta f’ effett ta ’ tnaqqis ta ’ glucose eżaġerat, bl- iżvilupp ta ’ sintomi ipogliċemiċi.
Hypoglycaemic symptoms without loss of consciousness or neurological findings should be treated with oral glucose and adjustments in dosage and/ or meal patterns.
Sintomi ipogliċemiċi mingħajr it- telf tas- sensi jew stħarriġ newroloġiku għandhom jiġu kkurati b’ glucose mill- ħalq u tibdil fid- dożaġġ u/ jew drawwiet ta ’ l- ikel.
Severe hypoglycaemic reactions with coma, seizure or other neurological symptoms should be treated with intravenous glucose.
Reazzjonijiet ipogliċemiċi severi b’ koma, aċċessjoni jew sintomi newrolġici oħra għandhom jiġu kkurati b ’ glucose minn ġol- vina.
As nateglinide is highly protein-bound, dialysis is not an efficient means of removing it from the blood.
Peress li nateglinide jagħqad ħafna mal- proteini, id- dijaliżi mhuwiex mod effiċjenti biex jitneħħa mid - demm.
Pharmacotherapeutic group:
5 Kategorija farmakoterapewtika:
D-phenylalanine derivative, ATC code:
Derivat ta ’ D- phenylalanine, Kodiċi ATC:
Nateglinide is an amino acid (phenylalanine) derivative, which is chemically and pharmacologically distinct from other antidiabetic agents.
Nateglinide huwa derivat ta ’ amino aċidu (phenylalanine), li huwa kimikament u farmakoloġikament distint minn aġenti antidijabetiċi oħra.
Nateglinide is a rapid, short-acting oral insulin secretagogue.
Nateglinide huwa sekretagogu ta ’ l- insulina orali li jaħdem malajr u fi żmien qasir.
Its effect is dependent on functioning beta cells in the pancreas islets.
L- effett tiegħu jiddependi fuq il- ħidma taċ- ċelluli beta fl- islets tal- frixa.
Early insulin secretion is a mechanism for the maintenance of normal glycaemic control.
Il- ħelsien kmieni ta ’ insulina huwa mekkaniżmu biex jinżamm kontroll gliċemiku normali.
Nateglinide, when taken before a meal, restores early or first phase insulin secretion, which is lost in patients with
Nateglinide, meta jittieħed qabel ikla, ireġġa ’ lura l- ħila ta ’ sekrezzjoni ta’ insulina minn kmieni jew mill- ewwel fażi, li tkun intilfet f’ pazjenti b’ dijabete tip 2, li tirriżulta fit- tnaqqis ta ’ glucose ta ’ wara l - ikel u tnaqqis ta ’ HbA1c.
Nateglinide closes ATP-dependent potassium channels in the beta-cell membrane with characteristics that distinguish it from other sulphonylurea receptor ligands.
Nateglinide jagħlaq kanali tal- potassium li jiddependu fuq l- ATP fir- rita ta ’ ċelluli beta b’ karatteristiċi li jiddistingwuh minn riċetturi legati ta ’ sulphonylurea oħrajn.
This depolarises the beta cell and leads to an opening of the calcium channels.
Dan jiddepolarizza ċ- ċellula beta u jirriżulta fil- ftuħ tal- kanali ta ’ calcium.
The resulting calcium influx enhances insulin secretion.
L- influss ta ’ calcium li jirriżulta jkabbar is- sekrezzjoni ta ’ insulina.
Electrophysiological studies demonstrate that nateglinide has 45– 300-fold selectivity for pancreatic beta cell versus cardiovascular K+ATP channels.
Studji elettrofiżjiologiċi juri li nateglinide għandu selettività għaċ- ċelluli beta tal- frixa ta ’ 45 – 300- il- darba iżjed mill- kanali kardjovaskolari K+ATP.
In type 2 diabetic patients, the insulinotropic response to a meal occurs within the first 15 minutes following an oral dose of nateglinide.
F’ pazjenti dijabetiċi tip 2, ir- reazzjoni insulinotropika għal ikla sseħħ fl- ewwel 15 minuti wara doża mill- ħalq ta ’ nateglinide.
This results in a blood-glucose-lowering effect throughout the meal period.
Dan jirriżulta f’ effett ta ’ tnaqqis ta ’ glucose fid- demm magħtul il- ħin ta ’ l - ikla.
Insulin levels return to baseline within 3 to 4 hours, reducing post-meal hyperinsulinaemia.
Il- livelli ta ’ insulina jirritornaw fil- linja bażi fi żmien 3 sa 4 siegħat, bi tnaqqis ta ’ iperinsulinemija ta ’ wara l- ikel.
Nateglinide-induced insulin secretion by pancreatic beta cells is glucose-sensitive, such that less insulin is secreted as glucose levels fall.
Is- sekrezzjoni ta ’ insulina mqanqla b’ nateglinide miċ- ċelluli beta tal- frixa hija sensittiva għal glucose, b’ mod li tiġi mgħamula inqas insulina malli jaqaw il- livelli ta ’ glucose.
Conversely, the coadministration of food or a glucose infusion results in an enhancement of insulin secretion.
Għal- kuntrarju t- teħid ta ’ Nateglinide flimkien ma ’ l- ikel jew infużjoni ta ’ glucose tirriżulta f’ żieda ta ’ sekrezzjoni ta ’ insulina.
In combination with metformin, which mainly affected fasting plasma glucose, the effect of nateglinide on HbA1c was additive compared to either agent alone.
Ikkombinat ma ’ metformin, li jeffettwa l- izjed glucose fil- plażma waqt is- sawm, l- effett ta ’ nateglinide fuq HbA1c kien additiv meta mqabbel ma ’ kull aġent waħdu.
Nateglinide efficacy was inferior to that of metformin in monotherapy (decrease in HbA1c (%) with metformin 500 mg three times daily monotherapy: – 1.23 [95% CI: – 1.48; – 0.99] and with nateglinide 120 mg three times daily monotherapy – 0.90 [95% CI: – 1.14; – 0.66]).
L- effikaċja ta ’ nateglinide kienet anqas minn dik ta ’ metformin f’ monoterapija (tnaqqis ta ’ HbA1c (%) b’ metformin 500 mg tlett darbiet kuljum b’ monoterapija: – 1. 23 [95% CI: – 1. 48; – 0. 99] u b’ nateglinide 120 mg tlett darbiet kuljum b’ monoterapija – 0. 90 [95% CI: – 1. 14; – 0. 66]).
The efficacy of nateglinide in combination with metformin has been compared to the combination of gliclazide plus metformin in a 6-month randomised, double-blind trial in 262 patients using a superiority design.
L- effikaċja ta ’ nateglinide ma ’ metformin kienet imqabbla mat- taħlita ta ’ gliclazide ma ’ metformin fi prova randomised ta ’ 6 xhur double blind f’ 262 pazjent b’ disinn ta ’ superjorità.
The decrease from baseline in HbA1c was – 0.41% in the nateglinide plus metformin group and – 0.57% in the gliclazide plus metformin group (difference 0.17%, [95% CI – 0.03, 0.36]).
It- tnaqqis mil- linja bażi f’ HbA1c kien - 0. 41% fil- grupp ta ’ nateglinide ma ’ metformin u - 0. 57% fil- grupp ta ’ gliclazide ma ’ metformin (differenza ta ’ 0. 17%, [95% CI - 0. 03, 0. 36]).
Both treatments were well tolerated.
Iż- żewġ kuri kienu tollerati sew.
An outcome study has not been conducted with nateglinide, therefore the long-term benefits associated with improved glycaemic control have not been demonstrated.
Studju tar- riżultati ma sarx b’ nateglinide, għalhekk il- benefiċċji fit- tul assoċjati ma ’ titjib tal- kontroll gliċemiku għadhom ma ntwerewx.
Absorption and bioavailability Nateglinide is rapidly absorbed following oral administration of Starlix tablets prior to a meal, with mean peak drug concentration generally occurring in less than 1 hour.
Assorbiment u biodisponibilità Nateglinide jiġi assorbit malajr wara li jingħataw pilloli Starlix mill- ħalq qabel ikla, bil- medja ta ’ l - ogħla konċentrazzjoni tal- mediċina ġeneralment isseħħ f’ inqas minn siegħa.
Nateglinide is rapidly and almost completely (≥ 90%) absorbed from an oral solution.
Nateglinide jiġi assorbit malajr u kważi għall- kollox (≥ 90%) minn soluzzjoni orali.
Absolute oral bioavailability is estimated to be 72%.
Il- biodisponibilità orali assoluta hija stimata li hi 72%.
In type 2 diabetic patients given Starlix over the dose range 60 to 240 mg before three meals per day for one week, nateglinide showed linear pharmacokinetics for both AUC and Cmax, and tmax was independent of dose.
F’ pazjenti dijabetiċi tip 2 mogħtija Starlix fuq firxa ta ’ dożi minn 60 sa 240 mg qabel tlett ikliet kuljum għall ġimgħa, nateglinide wera farmakokinetiċi linjari għal AUC u Cmax, u tmax li kien independenti mid- doża.
Distribution The steady-state volume of distribution of nateglinide based on intravenous data is estimated to be approximately 10 litres.
Distribuzzjoni Il- volum ta ’ distribuzzjoni fi stat fiss ta ’ nateglinide bażat fuq tagħrid miġbur minn użu għal ġol- vini huwa stimat li jkun madwar 10 litri.
In vitro studies show that nateglinide is extensively bound (97– 99%) to serum proteins, mainly serum albumin and to a lesser extent alpha1-acid glycoprotein.
Studji in vitro juru li nateglinide jeħel b’ mod estensiv mal - proteini tas- serum (97– 99%), l- aktar ma ’ l- albumina tas- serum u f’ ammonti iżgħar ma ’ l- aċidu alfa1 - glijkoproteina.
The extent of serum protein binding is independent of drug concentration over the test range of 0.1– 10 µg Starlix/ ml.
6 medda ta ’ 0. 1– 10 µg Starlix/ ml.
Metabolism Nateglinide is extensively metabolised.
Metaboliżmu Nateglinide huwa metabolizzat b’ mod estensiv.
The main metabolites found in humans result from hydroxylation of the isopropyl side-chain, either on the methine carbon, or one of the methyl groups; activity of the main metabolites is about 5– 6 and 3 times less potent than nateglinide, respectively.
Il- metaboliti prinċipali li jinstabu fil- bnedmin jirriżultaw minn idrossilazzjoni tal- katina tal- ġenb iżopropajl, jew fuq carbon methine, jew fuq wieħed mill gruppi methyl; l- attività tal- metaboli prinċipali hija ta ’ bejn wieħed u ieħor 5– 6 u 3 darbiet inqas b’ saħħitha minn nateglinide, rispettivament.
Minor metabolites identified were a diol, an isopropene and acyl glucuronide(s) of nateglinide; only the isopropene minor metabolite possesses activity, which is almost as potent as nateglinide.
Metaboli minuri identifikati huma diol, isopropene u acyl glucuronide( s) ta ’ nateglinide; il- metabolu minuri isopropene biss għandu xi attività, li hija b’ saħħitha kważi daqs dik ta ’ nateglinide.
Data available from both in vitro and in vivo experiments indicate that nateglinide is predominantly metabolised by CYP2C9 with involvement of CYP3A4 to a smaller extent.
Stħarriġ minn esperimenti in vitro u in vivo jindikaw illi nateglinide huwa metabolizzat l- aktar minn CYP2C9 b’ involviment minuri minn CYP3A4.
6 Excretion Nateglinide and its metabolites are rapidly and completely eliminated.
Tneħħija mill- ġisem Nateglinide u l- metaboli tiegħu huma mneħħija mill- ġisem malajr u għall- kollox.
Most of the [14C] nateglinide is excreted in the urine (83%), with an additional 10% eliminated in the faeces.
Il- parti l- kbira ta ’ [14C] nateglinide jitneħħa fl- awrina (83%), b ’ 10% oħra li jitneħħaew ma ’ l- ippurgar.
Approximately 75% of the administered [14C] nateglinide is recovered in the urine within six hours post-dose.
Madwar 75% ta ’ [14C] nateglinide li jingħata jiġi rkuprat mill- awrina sa sitt siegħat wara t- teħid tad- doża.
Approximately 6– 16% of the administered dose was excreted in the urine as unchanged drug.
Madwar 6– 16% tad- doża li ngħatat kienet imneħħija fl- awrina bħala mediċina mhux mibdula.
Plasma concentrations decline rapidly and the elimination half-life of nateglinide typically averaged 1.5 hours in all studies of Starlix in volunteers and type 2 diabetic patients.
Il - konċentrazzjonijiet fil- plażma malajr jonqsu u l- half- lifee tatt- tneħħija ta ’ nateglinide tipikament kellha medja ta ’ 1. 5 sigħat fl- istudji kollha ta ’ Starlix f’ voluntiera u f’ pazjenti dijabetiċi tip 2.
Consistent with its short elimination half-life, there is no apparent accumulation of nateglinide upon multiple dosing with up to 240 mg three times daily.
B’ mod konsistenti mal- half- life tat- tneħħija qasir li għandu, ma jidhirx li jkun hemm akkumulazzjoni ta ’ nateglinide meta jingħataw ħafna dożi sa 240 mg tlett darbiet kuljum.
Food effect When given post-prandially, the extent of nateglinide absorption (AUC) remains unaffected.
L- effett ta ’ l- ikel Meta jingħata wara l- ikel, ma jkunx hemm effett fuq kemm jiġi assorbit nateglinide (AUC).
However, there is a delay in the rate of absorption characterised by a decrease in Cmax and a delay in time to peak plasma concentration (tmax).
Iżda, hemm dewmien fir- rata ta ’ assorbiment ikkaratterizzata minn tnaqqis tas - Cmax u dewmien fil- ħin biex tintlaħaq l- ogħla konċentrazzjoni fil- plażma (tmax).
It is recommended that Starlix be administered prior to meals.
Huwa rakkomandat li Starlix jingħata qabel l- ikliet.
It is usually taken immediately (1 minute) before a meal but may be taken up to 30 minutes before meals.
Ġeneralment jittieħed mill- ewwel (1 minuta) qabel ikla iżda jista ’ jittieħed sa 30 minuta qabel l- ikliet.
Sub-populations Elderly:
Taqsima mill- populazjoni Anzjani:
Age did not influence the pharmacokinetic properties of nateglinide.
L- età m’ għandhiex effett fuq il- karatteristiċi farmakokinetiċi ta ’ nateglinide.
The systemic availability and half-life of nateglinide in non-diabetic subjects with mild to moderate hepatic impairment did not differ to a clinically significant degree from those in healthy subjects.
Id- disponibilità sistemika u l- half- life ta ’ nateglinide f’ pazjenti li mhumiex dijabetiċi b’ indeboliment epatiku ħafif għal moderat ma kienx differenti b’ mod klinikament sinifikanti minn dawk f’ pazjenti b’ saħħithom.
The systemic availability and half-life of nateglinide in diabetic patients with mild, moderate (creatinine clearance 31– 50 ml/ min) and severe (creatinine clearance 15– 30 ml/ min) renal impairment (not undergoing dialysis) did not differ to a clinically significant degree from those in healthy subjects.
Id- disponibilità sistemika u l- half- life ta ’ nateglinide f’ pazjenti b’ indeboliment renali ħafif għal moderat (tneħħija tal- krejatinina 31– 50 ml/ min) u severa (tneħħija tal- krejatinina 15 – 30 ml/ min) (mhux fuq dijaliżi) moderat ma kienx differenti b’ mod klinikament sinifikanti minn dawk f’ pazjenti b’ saħħithom.
There is a 49% decrease in Cmax of nateglinide in dialysis-dependent diabetic patients.
Hemm tnaqqis ta ’ 49% fis- Cmax ta ’ nateglinide f’ pazjenti dijabetiċi li jiddependu mid- dijaliżi.
The systemic availability and half-life in dialysis-dependent diabetic patients was comparable with healthy subjects.
Id- disponibilità sistemika u l- half- life f’ pazjenti dijabetiċi li jiddependu mid - dijaliżi kienet komparabbli ma ’ pazjenti b’ saħħithom.
Although safety was not compromised in this population dose adjustment may be required in view of low Cmax.
Għalkemm is- sigurtaà ma kienitx kompromessa f’ din il- popolazzjoni, tibdil fid- doża jista ’ jkun meħtieġ minħabba tnaqqis fis- Cmax.
No clinically significant differences in nateglinide pharmacokinetics were observed between men and women.
Ma kien hemm l- ebda differenzi klinikament sinifikanti fil- farmakokinetiċi ta ’ nateglinide bejn l - irġiel u n- nisa.
Preclinical data revealed no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential and toxicity to fertility and post-natal development.
Tagħrif ta ’ qabel l- użu kliniku magħmula fuq studji konvenzjonali ta ’ sigurtà farmakoloġika, effett tossiku minn dożi ripetuti, effett tossiku fuq il- ġeni, riskju ta ’ kanċer, effett tossiku fuq il- fertilità u żvilupp ta ’ wara t- twelid, ma ’ juri l- ebda periklu speċjali għall- bnedmin.
Nateglinide was not teratogenic in rats.
Nateglinide ma kienx teratoġeniku fil- firien.
In rabbits, at maternally toxic doses a higher incidence of foetuses with no gallbladder was observed.
Fil- fniek, b’ dożi li kkawżaw tossiċità għall- omm, dehret inċidenza ogħla ta ’ feti mingħajr marrara.
7 6.2 Incompatibilities
7 Lactose monohydrate Cellulose, microcrystalline Povidone Croscarmellose sodium Magnesium stearate Red iron oxide (E172) Hypromellose Titanium dioxide (E171) Talc Macrogol Silica, colloidal anhydrous
6.3 Shelf life
Ma jgħoddx f’ dan il- kaz.
PVC/ PE/ PVDC moulded foil with aluminium lidding foil.
PVC/ PE/ PVDC fojl iffurmat b’ fojl ta ’ aluminium li jgħatti.
Packs contain 12, 24, 30, 60, 84, 120 and 360 tablets.
Pakketti li fihom 12, 24, 30, 60, 84, 120 u 360 pillola.
03.04.2006
03. 04. 2001 Data ta ’ l- ewwel tiġdid:
10.
03. 04. 2006 8 10.
STARLIX 120 mg film-coated tablets
STARLIX 120 mg pilloli miksijin b’ rita
Each film-coated tablet contains 120 mg nateglinide.
Kull pillola miksija b’ rita fiha 120 mg nateglinide.
283 mg per tablet.
283 mg għal kull pillola.
120 mg yellow, ovaloid tablets with “ STARLIX” marked on one side and “ 120” on the other.
Pilloli b’ 120 mg sofor, b’ għamla fl- ovali b ’ “ STARLIX ” immarkat fuq naħa u “ 120 ” fuq l- oħra.
Patients with hepatic impairment No dose adjustment is necessary for patients with mild to moderate hepatic impairment.
10 M’ hemmx bżonn ta ’ tibdil fid- doża għal pazjenti b’ indeboliment tal- fwied ħafif għal moderat.
9 Patients with renal impairment No dose adjustment is necessary in patients with mild to moderate renal impairment.
Pazjenti b’ impediment renali M’ hemmx bżonn ta ’ tibdil fid- doża għal pazjenti b’ indeboliment renali ħafif għal moderat.
Symptoms of hypoglycaemia (unconfirmed by blood glucose levels) were observed in patients whose baseline HbA1c was close to the therapeutic target (HbA1C < 7.5%).
Sintomi ta ’ ipogliċemija (mhux ikkonfermati bil- livelli ta ’ glucose fid- demm) kienu osservati f’ pazjenti li kellhom il- linja bażi ta ’ HbA1c viċin għall- livell terapewtiku mixtieq (HbA1C < 7. 5%).
Specific patient groups Nateglinide should be used with caution in patients with moderate hepatic impairment.
11 Gruppi speċifiċi ta ’ pazjenti Nateglinide għandu jintuża b’ attenzjoni f’ pazjenti b’ indeboliment epatiku moderat.
10 4.5 Interaction with other medicinal products and other forms of interaction
4. 5 Prodotti mediċinali oħra li ma jaqblux ma ’ dan il- prodott u affarjiet oħra li jistgħu jibdlu l- effett farmaċewtiku tal- prodott
Pharmacotherapeutic group:
13 Kategorija farmakoterapewtika:
Nateglinide,
Il- ħelsien kmieni ta ’ insulina huwa mekkaniżmu biex jinżamm kontroll gliċemiku normali.
12 when taken before a meal, restores early or first phase insulin secretion, which is lost in patients with type 2 diabetes, resulting in a reduction in post-meal glucose and HbA1c.
Nateglinide, meta jittieħed qabel ikla, ireġġa ’ lura l- ħila ta ’ sekrezzjoni ta’ insulina minn kmieni jew mill- ewwel fażi, li tkun intilfet f’ pazjenti b’ dijabete tip 2, li tirriżulta fit- tnaqqis ta ’ glucose ta ’ wara l - ikel u tnaqqis ta ’ HbA1c.
The extent of serum protein binding is independent of drug concentration over the test range of 0.1– 10 µg Starlix/ ml.
14 medda ta ’ 0. 1– 10 µg Starlix/ ml.
Data available from both in vitro and in vivo experiments indicate that nateglinide is predominantly
Stħarriġ minn esperimenti in vitro u in vivo jindikaw illi nateglinide huwa metabolizzat l- aktar minn CYP2C9 b’ involviment minuri minn CYP3A4.
Excretion Nateglinide and its metabolites are rapidly and completely eliminated.
Tneħħija mill- ġisem Nateglinide u l- metaboli tiegħu huma mneħħija mill- ġisem malajr u għall- kollox.
5.3 Preclinical safety data
15 5. 3 Tagħrif ta 'qabel l- użu kliniku dwar is- sigurtà tal- medicina
Lactose monohydrate Cellulose, microcrystalline Povidone Croscarmellose sodium Magnesium stearate Yellow iron oxide (E172) Hypromellose Titanium dioxide (E171) Talc Macrogol
Lactose monohydrate Cellulose, microcrystalline Povidone Croscarmellose sodium Magnesium stearate Yellow iron oxide (E172) Hypromellose Titanium dioxide (E171) Talc Macrogol Silica, colloidal anhydrous
14 Silica, colloidal anhydrous
6. 2 Inkompatibilitajiet
6.2 Incompatibilities
Ma jgħoddx f’ dan il- kaz.
Not applicable
6. 3 Żmien kemm idum tajjeb il- prodott mediċinali
Novartis Europharm Limited Wimblehurst Road Horsham West Sussex, RH12 5AB United Kingdom
Novartis Europharm Limited Wimblehurst Road Horsham West Sussex, RH12 5AB 16 Ir- Renju Unit
03.04.2001 Date of first renewal:
03. 04. 2001 Data ta ’ l- ewwel tiġdid:
STARLIX 180 mg film-coated tablets
STARLIX 180 mg pilloli miksijin b’ rita
Each film-coated tablet contains 180 mg nateglinide.
Kull pillola miksija b’ rita fiha 180 mg nateglinide.
214 mg per tablet.
214 mg għal kull pillola.
180 mg red, ovaloid tablets with “ STARLIX” marked on one side and “ 180” on the other.
Pilloli b’ 180 mg ħomor, b’ għamla fl- ovali b ’ “ STARLIX ” immarkat fuq naħa u “ 180 ” fuq l- oħra.
Patients with hepatic impairment No dose adjustment is necessary for patients with mild to moderate hepatic impairment.
18 M’ hemmx bżonn ta ’ tibdil fid- doża għal pazjenti b’ indeboliment tal- fwied ħafif għal moderat.
16 Patients with renal impairment No dose adjustment is necessary in patients with mild to moderate renal impairment.
Pazjenti b’ impediment renali M’ hemmx bżonn ta ’ tibdil fid- doża għal pazjenti b’ indeboliment renali ħafif għal moderat.
Specific patient groups Nateglinide should be used with caution in patients with moderate hepatic impairment.
19 Gruppi speċifiċi ta ’ pazjenti Nateglinide għandu jintuża b’ attenzjoni f’ pazjenti b’ indeboliment epatiku moderat.
17 4.5 Interaction with other medicinal products and other forms of interaction
4. 5 Prodotti mediċinali oħra li ma jaqblux ma ’ dan il- prodott u affarjiet oħra li jistgħu jibdlu l- effett farmaċewtiku tal- prodott
4.7 Effects on ability to drive and use machines
20 4. 7 Effetti fuq il- ħila biex issuq u tħaddem magni
18 4.8 Undesirable effects
4. 8 Effetti mhux mixtieqa
Pharmacotherapeutic group:
21 Kategorija farmakoterapewtika:
19 when taken before a meal, restores early or first phase insulin secretion, which is lost in patients with type 2 diabetes, resulting in a reduction in post-meal glucose and HbA1c.
Nateglinide, meta jittieħed qabel ikla, ireġġa ’ lura l- ħila ta ’ sekrezzjoni ta’ insulina minn kmieni jew mill- ewwel fażi, li tkun intilfet f’ pazjenti b’ dijabete tip 2, li tirriżulta fit- tnaqqis ta ’ glucose ta ’ wara l - ikel u tnaqqis ta ’ HbA1c.
The extent of serum protein binding is independent of drug concentration over the test range of 0.1– 10 µg Starlix/ ml.
22 medda ta ’ 0. 1– 10 µg Starlix/ ml.
5.3 Preclinical safety data
23 5. 3 Tagħrif ta 'qabel l- użu kliniku dwar is- sigurtà tal- medicina
Lactose monohydrate Cellulose, microcrystalline Povidone Croscarmellose sodium Magnesium stearate Red iron oxide (E172) Hypromellose Titanium dioxide (E171) Talc Macrogol
Lactose monohydrate Cellulose, microcrystalline Povidone Croscarmellose sodium Magnesium stearate Red iron oxide (E172) Hypromellose Titanium dioxide (E171) Talc Macrogol Silica, colloidal anhydrous
21 Silica, colloidal anhydrous
6. 2 Inkompatibilitajiet
Novartis Europharm Limited Wimblehurst Road Horsham West Sussex, RH12 5AB United Kingdom
Novartis Europharm Limited Wimblehurst Road Horsham West Sussex, RH12 5AB 24 Ir- Renju Unit
Novartis Farma S. p. A.
Novartis Pharma S. p. A.
Via Provinciale Schito, 131 I-80058 Torre Annunziata - Napoli Italy
Via Provinciale Schito, 131 I- 80058 Torre Annunziata - Napoli L- Italja
Starlix 60 mg film-coated tablets Nateglinide
Starlix 60 mg pilloli miksijin b’ rita Nateglinide
1 film-coated tablet contains 60 mg nateglinide.
Pillola 1 miksija b’ rita fiha 60 mg nateglinide.
12 film-coated tablets 24 film-coated tablets 30 film-coated tablets 60 film-coated tablets 84 film-coated tablets 120 film-coated tablets 360 film-coated tablets
12- il pillola miksija b’ rita 24 pillola miksija b’ rita 30 pillola miksija b’ rita 60 pillola miksija b’ rita 84 pillola miksija b’ rita 120 pillola miksija b’ rita 360 pillola miksija b’ rita
Do not store above 30°C.
Taħżinx f’ temperatura 'l fuq minn 30°C.
28 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
31 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI