qanastek/EMEA-V3 huggingface dataset:
No clinical studies have been performed in children and adolescents < 18 years of age or in patients > 75 years of age.
Ma sarux studji kliniċi fuq tfal u adolexxenti < 18- il sena jew fuq pazjenti > 75 sena.
Therefore, treatment is not recommended in these patient groups.
Għaldaqstant, mhux rakkomandat trattament f' dawn il- gruppi ta 'pazjenti.
Careful dose titration is recommended in debilitated or malnourished patients.
Huwa rakkomandat li d- doża tkun ikkalkulata sew f’ pazjenti debboli jew neqsin mill- ikel sustanzjuż.
The initial and maintenance dosages should be conservative (see section 4.2).
Id- dożi inizjali u ta ’ manteniment għandhom ikunu moderati (ara sezzjoni 4. 2).
A number of drugs are known to influence repaglinide metabolism.
Numru ta 'mediċini huma magħrufa li jinfluwenzaw il- metaboliżmu ta ’ repaglinide.
Possible interactions should therefore be taken into account by the physician:
Għalhekk, it- tabib għandu jikkunsidra l- interazzjonijiet possibbli:
In vitro data indicate that repaglinide is metabolised predominantly by CYP2C8, but also by CYP3A4.
Informazzjoni in vitro tindika li repaglinide hu metabolizzat il- biċċa l- kbira minn CYP2C8, iżda wkoll minn CYP3A4.
Clinical data in healthy volunteers support CYP2C8 as being the most important enzyme involved in repaglinide metabolism with CYP3A4 playing a minor role, but the relative contribution of CYP3A4 can be increased if CYP2C8 is inhibited.
Informazzjoni klinika f’ voluntiera b’ saħħithom tappoġġja l- fatt li CYP2C8 hi l- iktar enzima importanti involuta fil- metaboliżmu ta ’ repaglinide, b’ CYP3A4 tilgħab rwol iżgħar, iżda l - kontribuzzjoni relattiva ta ’ CYP3A4 tista ’ tiżdied jekk CYP2C8 tkun inibita.
Consequently metabolism, and by that clearance of repaglinide, may be altered by drugs which influence these cytochrome P-450 enzymes via inhibition or induction.
Konsegwentement il - metaboliżmu, u minħabba f’ hekk it- tneħħija ta ’ repaglinide, jista ’ jinbidel minn mediċini li jinfluwenzaw dawn l- enzimi ta ’ ċitokrom P- 450 permezz ta ’ l- inibizzjoni jew l- induzzjoni.
Special care should be taken when both inhibitors of CYP2C8 and 3A4 are co- administered simultaneously with repaglinide.
Għandha tingħata attenzjoni speċjali meta l - inibituri ta ’ kemm CYP2C8 kif ukoll ta ’ 3A4 jingħataw fl- istess ħin ma ’ repaglinide
Based on in vitro data, repaglinide appears to be a substrate for active hepatic uptake (organic anion transporting protein OATP1B1).
Minn informazzjoni in vitro, jidher li repaglinide huwa sustrat għall- assorbiment epatiku attiv (proteina organika għat- trasport anijoniku OATP1B1).
Drugs that inhibit OATP1B1 may likewise have the potential to increase plasma concentrations of repaglinide, as has been shown for ciclosporin (see below).
Bl- istess mod, prodotti mediċinali li jinibixxu OATP1B1 jistgħu jkollhom il- potenzjal li jżidu l- konċentrazzjonijiet ta ’ repaglinide fil- plażma kif ġie muri għal ciclosporin (ara aktar ’ l isfel).
The following substances may enhance and/ or prolong the hypoglycaemic effect of repaglinide:
4 Is- sustanzi li ġejjin jistgħu jżidu u/ jew itawlu l- effett ipogliċemiku ta ’ repaglinide:
Gemfibrozil, clarithromycin, itraconazole, ketokonazole, trimethoprim, ciclosporin, other antidiabetic agents, monoamine oxidase inhibitors (MAOI), non selective beta blocking agents, angiotensin converting enzyme (ACE)-inhibitors, salicylates, NSAIDs, octreotide, alcohol, and anabolic steroids.
Gemfibrozil, clarithromycin, itraconazole, ketoconazole, trimethoprim, ciclosporin, sustanzi oħra kontra d- dijabete, inibituri ta ’ monoamine oxidase (MAOIs), sustanzi beta blokkanti mhux selettivi, inibituri ta ’ angiotensin converting enzyme (ACE), saliċilati, NSAIDs, octreotide, alkoħol, u sterojdi anaboliċi.
Co-administration of gemfibrozil, (600 mg twice daily), an inhibitor of CYP2C8, and repaglinide (a single dose of 0.25 mg) increased the repaglinide AUC 8.1-fold and Cmax 2.4-fold in healthy volunteers.
Meta repaglinide (doża waħda ta ’ 0. 25 mg) ingħata flimkien ma ’ gemfibrozil (600 mg darbtejn kuljum), inibitur ta ’ CYP2C8, kien hemm żieda fl- AUC ta ’ repaglinide ta ’ 8. 1 darbiet u fis- Cmax ta ’ 2. 4 darbiet f’ voluntiera b’ saħħithom.
Half-life was prolonged from 1.3 hr to 3.7 hr, resulting in possibly enhanced and prolonged blood glucose-lowering effect of repaglinide, and plasma repaglinide concentration at 7 hr was increased 28.6-fold by gemfibrozil.
Kien hemm żieda fil- half- life minn 1. 3 sa 3. 7 sigħat, li jirriżulta possibbilment f’ effett ipogliċemizzanti ta ’ repaglinide aktar qawwi u aktar fit- tul u l- konċentrazzjoni fil- plażma ta ’ repaglinide fis- seba ’ siegħa żdied b’ 28. 6 darbiet bit- teħid ta ’ gemfibrozil.
The concomitant use of gemfibrozil and repaglinide is contraindicated (see section 4.3).
L- użu ta ’ gemfibrozil flimkien ma ’ repaglinide huwa kontra- indikat (ara sezzjoni 4. 3).
4 repaglinide (a single dose of 0.25 mg) increased the repaglinide AUC, Cmax and t½ (1.6-fold, 1.4-fold and 1.2-fold respectively) with no statistically significant effects on the blood glucose levels.
Meta repaglinide (doża waħda ta ’ 0. 25 mg) ingħata flimkien ma ’ trimethoprim( 160 mg darbtejn kuljum), inibitur moderat ta ’ CYP2C8, kien hemm żieda fl- AUC, fis- Cmax u fit- t½ (1. 6 darbiet, 1. 4 darbiet u 1. 2 darbiet rispettivament) ta ’ repaglinide, mingħajr ebda effett statistikament sinifikanti fuq il- livelli tal- glucose fid- demm.
This lack of pharmacodynamic effect was observed with a sub-therapeutic dose of repaglinide.
Dan in- nuqqas ta ’ effett farmakodinamiku kien osservat b’ doża ta ’ repaglinide li kienet inqas minn doża terapewtika.
Since the safety profile of this combination has not been established with dosages higher than 0.25 mg for repaglinide and 320 mg for trimethoprim, the concomitant use of trimethoprim with repaglinide should be avoided.
Minħabba li l- profil tas- sigurtà ta ’ din il - kombinazzjoni ma ġiex stabbilit b’ doża ogħla minn 0. 25 mg għal repaglinide u b’ doża ogħla minn 320 mg għal trimethoprim, l- użu fl- istess ħin ta ’ trimethoprim ma ’ repaglinide għandu jiġi evitat.
If concomitant use is necessary, careful monitoring of blood glucose and close clinical monitoring should be performed (see section 4.4).
Jekk l- użu fl- istess ħin ikun meħtieġ, għandu jsir monitoraġġ bir- reqqa tal- glucose fid- demm u monitoraġġ kliniku mill- qrib (ara sezzjoni 4. 4).
Rifampicin, a potent inducer of CYP3A4, but also CYP2C8, acts both as an inducer and inhibitor of the metabolism of repaglinide.
Rifampicin, li b’ mod qawwi jikkawża l- induzzjoni ta ’ CYP3A4, iżda wkoll ta ’ CYP2C8, jaġixxi kemm ta ’ induttur u kemm ta ’ inibitur fil- metaboliżmu ta ’ repaglinide.
Seven days pre-treatment with rifampicin (600 mg), followed by co- administration of repaglinide (a single dose of 4 mg) at day seven resulted in a 50% lower AUC (effect of a combined induction and inhibition).
Kura minn qabel għal sebat ijiem b’ rifampicin (600 mg), segwit b’ teħid konkomitanti ta ’ repaglinide (doża waħda ta ’ 4 mg), fis - seba ’ jum irriżulta f’ tnaqqis ta ’ 50% fl’ AUC (effett kemm ta ’ induzzjoni kif ukoll ta ’ inibizzjoni).
When repaglinide was given 24 hours after the last rifampicin dose, an 80% reduction of the repaglinide AUC was observed (effect of induction alone). Concomitant use of rifampicin and repaglinide might therefore induce a need for repaglinide dose adjustment which should be based on carefully monitored blood glucose concentrations at both initiation of rifampicin treatment (acute inhibition), following dosing (mixed inhibition and induction), withdrawal (induction alone) and up to approximately two weeks after withdrawal of rifampicin where the inductive effect of rifampicin is no longer present.
Dan għandu jkun ibbażat fuq il- konċentrazzjonijiet tal- glucose fid- demm li jkunu mmonitorjati bir- reqqa, kemm fil- bidu tal - kura b’ rifampicin (inibizzjoni akuta), kemm fid- dożi suċċessivi (taħlita ta ’ inibizzjoni u induzzjoni), kemm meta titwaqqaf il- kura (induzzjoni waħidha) u kif ukoll sa madwar ġimagħtejn wara li titwaqqaf il- kura b’ rifampicin, meta l- effett induttiv ta ’ rifampicin ma jkunx għadu hemm.
It can not be excluded that other inducers, e. g. phenytoin, carbamazepine, phenobarbital, St John’ s wort, may have a similar effect.
John’ s wort, jista ’ jkollhom effett simili.
The effect of ketoconazole, a prototype of potent and competitive inhibitors of CYP3A4, on the pharmacokinetics of repaglinide has been studied in healthy subjects.
L- effett ta ’ ketoconazole, l- eżempju klassiku ta ’ inibituri qawwijin u kompetittivi ta ’ CYP3A4, fuq il - farmakokinetika ta ’ repaglinide, kien studjat f’ pazjenti b’ saħħithom.
Co-administration of 200 mg ketoconazole increased the repaglinide (AUC and Cmax) by 1.2-fold with profiles of blood glucose concentrations altered by less than 8% when administered concomitantly (a single dose of 4 mg repaglinide).
It- teħid flimkien ma ’ 200 mg ta ’ ketoconazole żied l- AUC u s - Cmax ta ’ repaglinide b’ 1. 2 darbiet, bil- profili tal- konċentrazzjonijiet tal - glucose fid- demm li nbidlu b’ inqas minn 8% meta ngħataw fl- istess ħin (doża waħda ta ’ 4 mg ta ’ repaglinide).
Co-administration of 100 mg itraconazole, an inhibitor of CYP3A4, has also been studied in healthy volunteers, and increased the AUC by 1.4-fold.
It- teħid flimkien ma ’ 100 mg ta ’ itraconazole, inibitur ta ’ CYP3A4, kien studjat ukoll f’ voluntiera b’ saħħithom, u żied l- AUC b’ 1. 4 darbiet.
No significant effect on the glucose level in healthy volunteers was observed.
L- ebda effett sinifikanti fuq il- livell tal- glucose f’ voluntiera b’ saħħithom ma kien osservat.
In an interaction study in healthy volunteers, co-administration of 250 mg clarithromycin, a potent mechanism-based inhibitor of CYP3A4, slightly increased the repaglinide (AUC) by 1.4-fold and Cmax by 1.7-fold and increased the mean incremental AUC of serum insulin by 1.5-fold and the maximum concentration by 1.6-fold.
Fi studju dwar l- interazzjoni bejn il- mediċini, li sar f’ voluntiera b’ saħħithom, it- teħid flimkien ma ’ 250 mg ta ’ clarithromycin, inibitur qawwi ta ’ CYP3A4 fuq livell ta ’ mekkaniżmu ta ’ azzjoni, żied bi ftit l- AUC ta ’ repaglinide b’ 1. 4 darbiet u s- Cmax b’ 1. 7 darbiet, u żied il- medja inkrementali ta ’ l- AUC ta ’ l- insulina tas- serum b’ 1. 5 darbiet u l - konċentrazzjoni massima b’ 1. 6 darbiet.
The exact mechanism of this interaction is not clear.
Il- mekkaniżmu preċiż ta ’ din l- interazzjoni m’ huwiex ċar.
In a study conducted in healthy volunteers, the concomitant administration of repaglinide (a single dose of 0.25 mg) and ciclosporin (repeated dose at 100 mg) increased repaglinide AUC and Cmax about 2.5-fold and 1.8-fold respectively.
F’ studju magħmul f’ volontiera b’ saħħithom, l- għoti fl- istess ħin ta ’ repaglinide (doża waħda ta ’ 0. 25 mg) u ciclosporin (doża ripetuta ta ’ 100 mg) żied l- AUC u s- Cmax ta ’ repaglinide b’ 1. 8 u b’ 2. 5 darbiet rispettivament.
Since the interaction has not been established with dosages higher than 0.25 mg for repaglinide, the concomitant use of ciclosporin with repaglinide should be avoided.
Peress li l- interazzjoni ma ġietx stabbiliti għal dożi ta ’ repaglinide ogħla minn 0. 25 mg, l- użu fl- istess ħin ta ’ ciclosporin u repagline għandu jiġi evitat.
If the combination appears necessary, careful clinical and blood glucose monitoring should be performed (see section 4.4).
Jekk jidher li l- użu flimkien ikun bżonnjuż, għandu jkun hemm monitoraġġ mill- viċin kemm mil- lat kliniku u kemm taz- zokkor fid- demm (ara sezzjoni 4. 4).
β -blocking agents may mask the symptoms of hypoglycaemia.
5 Imblokkaturi tar- riċetturi Beta jistgħu jaħbu s- sintomi ta ’ l- ipogliċemija.
Co-administration of cimetidine, nifedipine, oestrogen, or simvastatin with repaglinide, all CYP3A4 substrates, did not significantly alter the pharmacokinetic parameters of repaglinide.
It- teħid fl- istess ħin ta ’ cimetidine, nifedipine, oestrogen, jew simvastatin ma ’ repaglinide, kollha sustanzi li fuqhom jaġixxi CYP3A4, ma bidlux b’ mod sinifikanti l- parametri farmakokinetiċi ta ’ repaglinide.
Repaglinide had no clinically relevant effect on the pharmacokinetic properties of digoxin, theophylline or warfarin at steady state, when administered to healthy volunteers.
Repaglinide ma kellu l- ebda effett kliniku rilevanti fuq il- karatteristiċi farmakokinetiċi ta 'digoxin, theophylline jew warfarin fi stat fiss, meta ngħata lill- voluntiera b' saħħithom.
Dosage adjustment of these compounds when co-administered with repaglinide is therefore not necessary.
Għalhekk, m’ hemmx bżonn ta ’ tibdil fid- doża ta 'dawn is- sustanzi meta jingħataw flimkien ma ’ repaglinide.
The following substances may reduce the hypoglycaemic effect of repaglinide:
Is- sustanzi li ġejjin jistgħu jnaqqsu l- effett ipogliċemiku ta ’ repaglinide:
Oral contraceptives, rifampicin, barbiturates, carbamazepine, thiazides, corticosteroids, danazol, thyroid hormones and sympathomimetics.
Kontraċettivi orali, rifampicin, barbituriċi, carbamazepine, tijażidi, corticosterojdi, danazol, ormoni tat- tirojde u simpatomimetiċi.
When these medications are administered to or withdrawn from a patient receiving repaglinide, the patient should be observed closely for changes in glycaemic control.
Meta dawn il- mediċini jingħataw jew jitneħħew mit- terapija ta ’ pazjent li jkun qed jirċievi repaglinide, il- pazjent għandu jiġi osservat mill- qrib għal tibdiliet fil- kontroll gliċemiku.
When repaglinide is used together with other drugs that are mainly secreted by the bile, like repaglinide, any potential interaction should be considered.
Meta repaglinide jintuża flimkien ma 'sustanzi oħra li prinċipalment ikollhom tnixxija biljari, bħal repaglinide, wieħed għandu jikkunsidra kull interazzjoni li tista ’ sseħħ.
There are no studies of repaglinide in pregnant or lactating women.
Ma hemmx studji ta ’ repaglinide fuq nisa tqal jew li qed ireddgħu.
Therefore the safety of repaglinide in pregnant women cannot be assessed.
Għalhekk is- sigurtà ta ’ repaglinide fin- nisa tqal ma tistax tiġi analizzata.
Up to now repaglinide showed not to be teratogenic in animal studies.
Sa issa repaglinide ma weriex li huwa teratoġeniku fi studji fuq l - annimali.
Embryotoxicity, abnormal limb development in foetuses and new born pups, was observed in rats exposed to high doses in the last stage of pregnancy and during the lactation period.
F ’ firien li kienu esposti għal dożi għolja fl- aħħar stadju tat- tqala u waqt il- perijodu tat - treddigħ ġiet osservata l- embrijotossiċita`, żvilupp abnormali tar- riġel tal- feti u tal- frieħ li għadhom kemm twieldu.
Repaglinide is detected in the milk of experimental animals.
Repaglinide instab fil- ħalib ta 'l- annimali li jintużaw fl- esperimenti.
For that reason repaglinide should be avoided during pregnancy and should not be used in lactating women.
Għal din ir- raġuni repaglinide għandu jiġi evitat waqt t- tqala u m' għandux jintuża f' nisa li qed ireddgħu.
Patients should be advised to take precautions to avoid hypoglycaemia whilst driving.
Għandu jingħata parir lill- pazjenti biex jittieħdu l- prekawzjonijiet biex tiġi evitata l- ipogliċemija waqt is- sewqan.
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 importanti speċjalment f' dawk li ma jafux jew ma jafux sewwa x’ inhuma s - sinjali ta 'l- ipogliċemija jew li spiss ikollhom episodji ta' ipogliċemija.
The advisability of driving should be considered in these circumstances.
F’ dawn iċ- ċirkostanzi għandu jingħata parir li sewqan m’ għandux isir.
Based on the experience with repaglinide and with other hypoglycaemic agents the following adverse events have been seen:
Skond l- esperjenza b’ repaglinide u sustanzi oħra ipogliċemiċi, ġew osservati l- avvenimenti avversi li ġejjin:
Frequencies are defined as:
Il- frekwenzi huma mfissra bħala:
Common (≥ 1/ 100 to < 1/ 10); uncommon (≥ 1/ 1,000 to < 1/ 100); rare (≥ 1/ 10,000 to < 1/ 1,000); very rare (< 1/ 10,000); not known (cannot be estimated from the available data).
Komuni (≥ 1/ 100 sa < 1/ 10); mhux komuni (≥ 1/ 1000 sa 1/ 100); rari (≥ 1/ 10, 000 sa < 1/ 1, 000); rari ħafna (< 1/ 10, 000); mhux magħruf (ma tistax tittieħed stima mid- dejta disponibbli)
Immune system disorders Very rare:
Disturbi fis- sistema immuni Rari ħafna:
Allergy Generalised hypersensitivity reactions (e. g. anaphylactic reaction), or immunological reactions such as vasculitis.
Allerġija Reazzjonijiet ta ’ sensittività eċċessiva ġeneralizzati (eż. reazzjoni anafilattika) jew reazzjonijiet immunoloġiċi bħal vaskulite
Hypoglycaemia Not known:
Disturbi fil- metaboliżmu u n- nutrizzjoni Komuni: ipogliċemija Mhux magħruf:
Hypoglycaemic coma and hypoglycaemic unconsciousness As with other hypoglycaemic agents, hypoglycaemic reactions have been observed after administration of repaglinide.
Koma ipogliċemika jew telf tas- sensi ipogliċemika Bħal ma jiġri b’ sustanzi ipogliċemiċi oħra, reazzjonijiet ipogliċemiċi dehru meta ttieħed repaglinide.
These reactions are mostly mild and easily handled through intake of carbohydrates.
Ħafna minn dawn ir- reazzjonijiet huma ħfief u trattati bla diffikultà permezz ta 'teħid ta' karboidrati.
If severe, requiring third party assistance, infusion of glucose may be necessary.
Jekk ikunu serji, tant li tkun meħtieġa l- assistenza minn persuni oħra, jista ’ jkun hemm bżonn infużjoni ta 'glucose.
The occurrence of such reactions depends, as for every diabetes therapy, on individual factors, such as dietary habits, dosage, exercise and stress (see section 4.4).
Il- fatt li jseħħu dawn ir- reazzjonijiet jiddependi, bħal kull terapija tad- dijabete, fuq fatturi individwali, bħal it- tip ta ’ dieta, id- doża, l- eżerċizzju u l- istress (ara sezzjoni 4. 4).
Interactions with other medicinal products may increase the risk of hypoglycaemia (see section 4.5).
Interazzjonijiet ma ’ prodotti mediċinali oħra jistgħu jżidu r- riskju ta ’ ipogliċemija (ara sezzjoni 4. 5).
During post marketing experience, cases of hypoglycaemia have been reported in patients treated with repaglinide in combination with metformin or thiazolidinedione.
6 Mill- esperjenza miksuba bl- użu tal- prodott wara li tpoġġa fis- suq, ġew irrappurtati każijiet ta 'ipogliċemija f' pazjenti li kienu trattati b’ repaglinide flimkien ma' metformin jew ma ’ thiazolidinedione.
Gastro-intestinal disorders Common:
Disturbi gastro- intestinali Komuni:
Abdominal pain and diarrhoea Very rare:
Uġigħ addominali u dijarea Rari ħafna:
Vomiting and constipation Not known:
Rimettar u stitikezza Mhux magħruf:
Nausea Gastro-intestinal complaints such as abdominal pain, diarrhoea, nausea, vomiting and constipation have been reported in clinical trials.
Tqalligħ Ilmenti gastrointestinali bħal uġigħ addominali, dijarea, dardir, rimettar u stitikezza ġew irrappurtati fi studji kliniċi.
The rate and severity of these symptoms did not differ from that seen with other oral insulin secretagogues.
Ir- rata u l- gravità ta 'dawn is- sintomi ma kinux differenti minn dawk li dehru bi prodotti oħra li jikkawżaw is- sekrezzjoni ta ’ l- insulina, li jingħataw mill- ħalq.
Hypersensitivity Hypersensitivity reactions of the skin may occur as erythema, itching, rashes and urticaria.
Sensittività eċċessiva Reazzjonijiet ta 'sensittività eċċessiva fil- ġilda jistgħu jseħħu bħal eritema, ħakk, raxx u urtikarja.
There is no reason to suspect cross-allergenicity with sulphonylurea drugs due to the difference of the chemical structure.
Ma hemm l- ebda raġuni għalxiex għandu jkun hemm xi suspett ta ’ allerġija trasversali mal- mediċini tat- tip sulphonylurea peress li għandhom struttura kimika differenti.
6 Changes in blood glucose levels have been known to result in transient visual disturbances, especially at the commencement of treatment.
Disturbi fl- għajnejn Rari ħafna: disturbi tal- vista Tibdiliet fil- livell tal- glucose fid- demm huma magħrufa li jirriżultaw f' disturbi tranżitorji tal- vista, speċjalment fil- bidu tal- kura.
Such disturbances have only been reported in very few cases after initiation of repaglinide treatment.
Dawn id- disturbi ġew irrappurtati biss fi ftit każijiet wara l- bidu tal- kura b’ repaglinide.
No such cases have led to discontinuation of repaglinide treatment in clinical trials.
L- ebda wieħed minn dawn il- każijiet ma wassal biex titwaqqaf il- kura b’ repaglinide fi studji kliniċi.
Cardiac disorders Rare:
Disturbi fil- qalb Rari:
Cardiovascular disease Type 2 diabetes is associated with an increased risk for cardiovascular disease.
Mard kardjovaskulari Id- dijabete tat - tip 2 hi marbuta ma ’ żieda fir- riskju ta ’ mard kardjovaskulari.
In one epidemiological study, a higher incidence of acute coronary syndrome was reported in the repaglinide group.
F’ studju wieħed epidemjoloġiku, ġie rrappurtat inċidenza ogħla tas- sindromu koronarju akut fil- grupp ta ’ repaglinide.
However, the causality of the relationship remains uncertain (see sections 4.4 and 5.1).
Madankollu, il- kawżalità tar- relazzjoni tibqa ’ inċerta (ara sezzjonijiet 4. 4 u 5. 1).
Hepato-biliary disorders Very rare:
Disturbi fil- fwied u fil- marrara Rari ħafna:
Hepatic function abnormal In very rare cases, severe hepatic dysfunction has been reported.
Funzjoni epatika mhux normali F’ każijiet rari ħafna ġiet irrapportata disfunzjoni epatika severa.
However, a causal relationship with repaglinide has not been established.
Madankollu, ma ġietx irrapportata relazzjoni kawżali ma ’ repaglinide.
Increased liver enzymes Isolated cases of increase in liver enzymes have been reported during treatment with repaglinide.
Żieda fl- enzimi tal- fwied Każijiet iżolati ta 'żieda fl- enzimi tal- fwied ġew irrappurtati waqt kura b’ repaglinide.
Most cases were mild and transient, and very few patients discontinued treatment due to increase in liver enzymes.
Il- maġġoranza tal- każijiet kienu ħfief u tranżitorji, u ftit kienu dawk il- pazjenti li ma komplewx il- kura minħabba ż - żieda fl- enzimi tal- fwied.
Repaglinide has been given with weekly escalating doses from 4 - 20 mg four times daily in a 6 week period.
Repaglinide ngħata b' żieda fid- doża kull ġimgħa minn 4- 20 mg erba 'darbiet kuljum f' perijodu ta' 6 ġimgħat.
No safety concerns were raised.
Ma ġewx irrappurtati ebda tip ta ’ problema f’ dak li għandu x’ jaqsam is- siġurtà tal - mediċina..
Should these symptoms occur, adequate action should be taken to correct the low blood glucose (oral carbohydrates).
F' dan l- istudju l- ipogliċemija kienet evitata permezz ta 'żieda fit- teħid ta' kaloriji, iżda doża eċċessiva relattiva tista 'tirriżulta f' effett li jbaxxi l- glucose b’ mod esaġerat u f’ sintomi ipogliċemiċi (sturdament, għaraq, rogħda, uġigħ ta' ras eċc.) Jekk ikun hemm dawn is- sintomi, għandha tittieħed azzjoni adegwata biex jiġi kkoreġut il- glucose baxx fid- demm (karboidrati mill- ħalq).
More severe hypoglycaemia with seizure, loss of consciousness or coma should be treated with IV glucose.
Ipogliċemija aktar serja assoċjata ma ’ konvulżjonijiet, telf tas- sensi jew koma għandha tiġi ttrattata bi glucose mogħti minn ġol- vini
Carbamoylmethyl benzoic acid derivative, ATC code:
Grupp farmako- terapewtiku: derivattiv ta ’ Carbamoylmethyl benzoic acid, Kodiċi ATC:
Repaglinide is a novel short-acting oral secretagogue.
7 Repaglinide huwa prodott ġdid li jikkawża s- sekrezzjoni ta ’ l- insulina, jittieħed mill- ħalq u jaħdem għal ħin qasir.
Repaglinide lowers the blood glucose levels acutely by stimulating the release of insulin from the pancreas, an effect dependent upon functioning β -cells in the pancreatic islets.
Repaglinide inaqqas b' mod akut il- livelli tal- glucose fid- demm billi jistimula l- ħruġ ta 'l- insulina mill- frixa, effett li jiddependi fuq il- funzjoni taċ- ċelloli β fl- islets pankreatiċi.
Repaglinide closes ATP-dependent potassium channels in the β -cell membrane via a target protein different from other secretagogues.
Repaglinide jagħlaq il- kanali tal- potassju dipendenti fuq l- ATP fil- membrana taċ- ċelloli β permezz ta 'proteina partikolari li hija differenti minn prodotti oħra li jikkawżaw is- sekrezzjoni ta ’ l- insulina.
This depolarises the β -cell and leads to an opening of the calcium channels.
Din l- azzjoni tiddepolarizza ċ- ċellola β u twassal għall- ftuħ tal- kanali tal- kalċju.
The resulting increased calcium influx induces insulin secretion from the β -cell.
Iż- żieda fid- dħul intraċellulari ta ’ kalċju li jirriżulta minn din l- azzjoni jistimula s- sekrezzjoni ta 'l- insulina miċ- ċellula β.
In type 2 diabetic patients, the insulinotropic response to a meal occurred within 30 minutes after an oral dose of repaglinide.
F' pazjenti bid- dijabete tat- tip 2, ir- rispons insulinotropiku għall- ikel, seħħ fi żmien 30 minuta wara li ttieħdet doża orali ta ’ repaglinide.
This resulted in a blood glucose-lowering effect throughout the meal period.
Dan wassal biex l- effett ta ’ tnaqqis fil- livell tal- glucose fid- demm jibqa ’ għall- perijodu kollu ta 'l- ikla.
The elevated insulin levels did not persist beyond the time of the meal challenge.
Il- livelli għolja ta 'l- insulina ma ppersistewx wara l- ħin ta ’ l- ikla.
Plasma repaglinide levels decreased rapidly, and low drug concentrations were seen in the plasma of type 2 diabetic patients 4 hours post-administration.
Il- livelli ta ’ repaglinide fil- plażma naqsu malajr, u l- konċentrazzjonijiet tal- mediċina fil- plażma tal - pazjenti li għandhom id- dijabete tat- tip 2 kienu baxxi erba 'sigħat wara t- teħid.
A dose-dependent decrease in blood glucose was demonstrated in type 2 diabetic patients when administered in doses from 0.5 to 4 mg repaglinide.
Meta pazjenti bid- dijabete tat- tip 2 ingħataw dożi minn 0. 5 sa 4 mg ta ’ repaglinide ġie muri li t- tnaqqis fil- livell tal- glucose fid- demm huwa dipendenti fuq id- doża.
Clinical study results have shown that repaglinide is optimally dosed in relation to main meals (preprandial dosing).
Riżultati ta 'studji kliniċi wrew li l- aħjar mod li jiġi meħud repaglinide huwa li jingħata skond l- ikliet prinċipali (teħid qabel l- ikel).
Doses are usually taken within 15 minutes of the meal, but the time may vary from immediately preceding the meal to as long as 30 minutes before the meal.
Normalment, id- dożi jittieħdu 15- il minuta qabel l- ikel, imma l- ħin jista 'jvarja minn eżatt qabel l- ikel sa 30 minuta qabel l- ikel.
7 treated patients as compared to sulfonylurea treated patients (see sections 4.4 and 4.8).
Studju epidemjoloġiku wieħed wera żieda fir- riskju tas- sindromu koronarju akut f’ pazjenti kkurati b’ repaglinide meta mqabbla ma ’ pazjenti kkurati b’ sulfonylureas (ara sezzjonijiet 4. 4 u 4. 8).
Repaglinide is rapidly absorbed from the gastrointestinal tract, which leads to a rapid increase in the plasma concentration of the drug.
Repaglinide jiġi assorbit malajr mill- passaġġ gastrointestinali, li jwassal għal żieda b’ mod mgħaġġel fil- konċentrazzjoni tal- mediċina fil- plażma.
The peak plasma level occurs within one hour post administration.
L- ogħla livell fil- plażma jintlaħaq wara siegħa li jkun ittieħed.
After reaching a maximum, the plasma level decreases rapidly, and repaglinide is eliminated within 4 - 6 hours.
Wara li jintlaħaq il- livell massimu, il- livell fil- plażma jonqos malajr, u repaglinide jiġi eliminat f' perijodu ta ’ 4- 6 sigħat.
The plasma elimination half-life is approximately one hour.
Il- half- life ta ’ l- eliminazzjoni mill- plażma hija bejn wieħed u ieħor ta ’ siegħa.
Repaglinide pharmacokinetics are characterised by a mean absolute bioavailability of 63% (CV 11%), low volume of distribution, 30 L (consistent with distribution into intracellular fluid), and rapid elimination from the blood.
Il- farmakokinetika ta ’ repaglinide hija kkaratterizzata minn medja ta ’ bijodisponibilita` assoluta ta '63% (CV 11%), volum baxx ta' distribuzzjoni, 30 L (konsistenti ma ’ distribuzzjoni fil- fluwidu intraċellulari), u eliminazzjoni b’ mod mgħaġġel mid- demm.
A high interindividual variability (60%) in repaglinide plasma concentrations has been detected in the clinical trials.
Fl- istudji kliniċi, ġiet osservata differenza kbira fil- konċentrazzjonijiet ta ’ repaglinide fil- plażma bejn individwu u ieħor (60%).
Intraindividual variability is low to moderate (35%) and as repaglinide should be titrated against the clinical response, efficacy is not affected by interindividual variability.
Id- differenza fil- konċentrazzjonijiet ta ’ repaglinide fl- istess individwu kienet baxxa għal moderata (35%) u peress illi d- doża ta ’ repaglinide għandha tiġi kkalkulata skond ir - rispons kliniku, id- differenzi ta ’ bejn individwu u ieħor ma jaffettwawx l- effikaċja.
Repaglinide exposure is increased in patients with hepatic insufficiency and in the elderly type 2 diabetic patients.
L- espożizzjoni ta ’ repaglinide tiżdied f' pazjenti b' insuffiċjenza tal- fwied u f' pazjenti anzjani li għandhom id- dijabete tat- tip 2.
The AUC (SD) after 2 mg single dose exposure (4 mg in patients with hepatic insufficiency) was 31.4 ng/ ml x hr (28.3) in healthy volunteers, 304.9 ng/ ml x hr (228.0) in patients with hepatic insufficiency, and 117.9 ng/ ml x hr (83.8) in the elderly type 2 diabetic patients.
L- AUC (SD) wara espożizzjoni ta 'doża waħda ta' 2 mg (4 mg f' pazjenti b' insuffiċjenza tal- fwied) kienet ta ’ 31. 4 ng/ ml x siegħa (28. 3) f' voluntiera b' saħħithom, 304. 9 ng/ ml x siegħa (228. 0) f' pazjenti b' insuffiċjenza tal- fwied, u 117. 9 ng/ ml x siegħa (83. 8) fil - pazjenti anzjani bid- dijabete tat- tip 2.
After a 5 day treatment of repaglinide (2 mg x 3/ day) in patients with a severe impaired renal function (creatinine clearance:
Wara kura ta '5 tijiem b’ repaglinide( 2 mg x 3/ ġurnata) f' pazjenti b’ indeboliment renali gravi (tneħħija tal- krejatinina:
20-39 ml/ min.), the results showed a significant 2-fold increase of the exposure (AUC) and half-life (t1/ 2) as compared to subjects with normal renal function.
20- 39 ml/ min) ir- riżultati wrew żieda sinifikanti li kienu ta ’ darbtejn iżjed fl - espożizzjoni (AUC) u fil- half- life (t½), meta mqabbla ma ’ pazjenti b' funzjoni tal- kliewi normali.
Repaglinide is highly bound to plasma proteins in humans (greater than 98%).
Repaglinide jintrabat sew ma 'proteini tal- plażma fil- bniedem (aktar minn 98%).
No clinically relevant differences were seen in the pharmacokinetics of repaglinide, when repaglinide was administered 0, 15 or 30 minutes before a meal or in fasting state.
L- ebda differenzi, klinikament rilevanti, ma dehru fil- farmakokinetika ta ’ repaglinide, meta ngħata 0, 15 jew 30 minuta qabel ikla jew fi stat ta 'sawm.
Repaglinide is almost completely metabolised, and no metabolites with clinically relevant hypoglycaemic effect have been identified.
Repaglinide jiġi metabolizzat kważi kollu, u ma ġewx identifikati metaboli b' effett ipogliċemiku ta ’ rilevanza klinika.
Repaglinide and its metabolites are excreted primarily via the bile.
8 Repaglinide u l- metaboli tiegħu jiġu mneħħija primarjament permezz tal- bile.
A small fraction (less than 8%) of the administered dose appears in the urine, primarily as metabolites.
Frazzjoni żgħira (anqas minn 8%) tad- doża mogħtija tidher fl- awrina, primarjament bħala metaboli.
Less than 1% of the parent drug is recovered in faeces.
Inqas minn 1% tal - mediċina oriġinali toħroġ fl- ippurgar.
Non-clinical data revealed no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity and carcinogenic potential.
Informazzjoni li mhiex klinika, magħmula fuq studji konvenzjonali ta ’ sigurtà farmakoloġika, effett tossiku minn dożi ripetuti, effett tossiku fuq il- ġeni u riskju ta ’ kanċer, ma turi l- ebda periklu speċjali għall- bnedmin.
Microcrystalline cellulose (E460) Calcium hydrogen phosphate, anhydrous Maize starch Amberlite (polacrilin potassium) Povidone (polyvidone) Glycerol 85% Magnesium stearate Meglumine Poloxamer
Microcrystalline cellulose (E460) Calcium hydrogen phosphate, anhydrous Maize starch Amberlite (polacrilin potassium) Povidone (polyvidone) Glycerol 85% Magnesium stearate Meglumine Poloxamer
Not applicable.
Ma jgħoddx f’ dan ’ il- każ.
8 6.3 Shelf life
6. 3 Żmien kemm idum tajjeb il- prodott mediċinali
5 years.
5 snin
The blister pack (aluminium/ aluminium) contains 30, 90, 120 or 270 tablets, respectively.
Il- pakkett tal- folji (aluminju/ aluminju) fih 30, 90, 120 jew 270 pillola, rispettivament.
Novo Nordisk A/ S Novo Allé DK-2880 Bagsværd Denmark
Novo Nordisk A/ S Novo Alle 'DK- 2880 Bagsværd Id- Danimarka
EU/ 1/ 98/ 076/ 004-006, EU/ 1/ 98/ 076/ 023
9 EU/ 1/ 98/ 076/ 004- 006, EU/ 1/ 98/ 076/ 023
17 August 1998 Date of last renewal:
17 ta ’ Awwissu, 1998 Data ta ’ l- aħħar tiġdid:
23 July 2008
23 ta 'Lulju 2008
NovoNorm 1 mg tablets
NovoNorm 1 mg pilloli
Each tablet contains 1 mg of repaglinide.
Kull pillola fiha 1 mg ta ’ repaglinide
Repaglinide tablets are yellow, round and convex and engraved with Novo Nordisk logo (Apis bull).
Il- pilloli ta ’ repaglinide huma sofor, tondi u konvessi u inċiżi bil- logo Novo Nordisk (Apis bull).
In the case of concomitant use with other active substances refer to sections 4.4 and 4.5 to assess dosage.
11 F’ każ ta ’ użu fl- istess ħin ta ’ sustanzi attivi oħra irreferi għal sezzjonijiet 4. 4 u 4. 5 biex tiċċekkja d - dożaġġ.
Initial dose The dosage should be determined by the physician, according to the patient’ s requirements.
Doża inizjali Id- doża għandha tiġi determinata mit- tabib, skond il- ħtiġijiet tal- pazjent.
One to two weeks should elapse between titration steps (as determined by blood glucose response).
Bejn il- perijodi ta ’ aġġustament fid - doża għandhom jgħaddu minn ġimgħa sa ġimagħtejn (kif determinat mir- rispons gliċemiku).
If patients are transferred from another oral hypoglycaemic agent the recommended starting dose is
Jekk pazjenti jiġu trasferiti minn sustanza orali oħra li tbaxxi l- livell ta ’ glucose fid- demm, huwa rakkomandat li l- kura għandha tibda b’ doża ta ’ 1 mg.
Eight percent of one dose of repaglinide is excreted through the kidneys and total plasma clearance of the product is decreased in patients with renal impairment.
Tmienja fil- mija ta ’ doża waħda ta ’ repiglinide tiġi eliminata mill- kliewi u t- tneħħija totali tal- prodott mill- plażma jonqos f' pazjenti li għandhom indeboliment renali.
Repaglinide like other insulin secretagogues, is capable of producing hypoglycaemia.
12 Repaglinide bħas- sustanzi l- oħra li jikkawżaw is- sekrezzjoni ta ’ l- insulina, jista 'jikkawża ipogliċemija.
The blood glucose-lowering effect of oral hypoglycaemic agents decreases in many patients over time.
L- effett ta 'sustanzi ipogliċemiċi, orali, li jbaxxu l- glucose fid- demm maż- żmien jonqos f' ħafna pazjenti.
Special care should be taken when both inhibitors of CYP2C8 and 3A4 are co- administered simultaneously with repaglinide.
Għandha tingħata attenzjoni speċjali meta l - inibituri ta ’ kemm CYP2C8 kif ukoll ta ’ 3A4 jingħataw fl- istess ħin ma ’ repaglinide.
Based on in vitro data, repaglinide appears to be a substrate for active hepatic uptake (organic anion transporting protein OATP1B1).
13 Minn informazzjoni in vitro, jidher li repaglinide huwa sustrat għall- assorbiment epatiku attiv (proteina organika għat- trasport anijoniku OATP1B1).
The following substances may enhance and/ or prolong the hypoglycaemic effect of repaglinide:
Is- sustanzi li ġejjin jistgħu jżidu u/ jew itawlu l- effett ipogliċemiku ta ’ repaglinide:
Co-administration of gemfibrozil (600 mg twice daily), an inhibitor of CYP2C8, and repaglinide (a single dose of 0.25 mg) increased the repaglinide AUC 8.1-fold and Cmax 2.4-fold in healthy volunteers.
Meta repaglinide (doża waħda ta ’ 0. 25 mg) ingħata flimkien ma ’ gemfibrozil (600 mg darbtejn kuljum), inibitur ta ’ CYP2C8, kien hemm żieda fl- AUC ta ’ repaglinide ta ’ 8. 1 darbiet u fis- Cmax ta ’ 2. 4 darbiet f’ voluntiera b’ saħħithom.
12 repaglinide (a single dose of 0.25 mg) increased the repaglinide AUC, Cmax and t½ (1.6-fold, 1.4-fold and 1.2-fold respectively) with no statistically significant effects on the blood glucose levels.
Meta repaglinide (doża waħda ta ’ 0. 25 mg) ingħata flimkien ma ’ trimethoprim( 160 mg darbtejn kuljum), inibitur moderat ta ’ CYP2C8, kien hemm żieda fl- AUC, fis- Cmax u fit- t½ (1. 6 darbiet, 1. 4 darbiet u 1. 2 darbiet rispettivament) ta ’ repaglinide, mingħajr ebda effett statistikament sinifikanti fuq il- livelli tal- glucose fid- demm.
Since the interaction has not been established with dosages higher than 0.25 mg for repaglinide, the concomitant use of ciclosporin with repaglinide should be avoided.
14 0. 25 mg, l- użu fl- istess ħin ta ’ ciclosporin u repagline għandu jiġi evitat.
β -blocking agents may mask the symptoms of hypoglycaemia.
Imblokkaturi tar- riċetturi Beta jistgħu jaħbu s- sintomi ta ’ l- ipogliċemija.
13 4.6 Pregnancy and lactation
4. 6 Tqala u Treddigħ
Embryotoxicity, abnormal limb development in foetuses and new born pups, was observed in rats exposed to high doses in the last stage of pregnancy and during the lactation period.
F’ firien li kienu esposti għal dożi għolja fl- aħħar stadju tat- tqala u waqt il- perijodu tat - treddigħ ġiet osservata l- embrijotossiċita`, żvilupp abnormali tar- riġel tal- feti u tal- frieħ li għadhom kemm twieldu.
For that reason repaglinide should be avoided during pregnancy and should not be used in lactating women.
Għal din ir- raġuni repaglinide għandu jiġi evitat waqt it- tqala u m' għandux jintuża f' nisa li qed ireddgħu.
If severe, requiring third party assistance, infusion of glucose may be necessary.
15 Jekk ikunu serji, tant li tkun meħtieġa l- assistenza minn persuni oħra, jista ’ jkun hemm bżonn infużjoni ta 'glucose.
During post marketing experience, cases of hypoglycaemia have been reported in patients treated with repaglinide in combination with metformin or thiazolidinedione.
Mill- esperjenza miksuba bl- użu tal- prodott wara li tpoġġa fis- suq, ġew irrappurtati każijiet ta 'ipogliċemija f' pazjenti li kienu trattati b’ repaglinide flimkien ma' metformin jew ma ’ thiazolidinedione.
There is no reason to suspect cross-allergenicity with sulphonylurea drugs due to the difference in chemical structure.
Ma hemm l- ebda raġuni għalxiex għandu jkun hemm xi suspett ta ’ allerġija trasversali mal- mediċini tat- tip sulphonylurea peress li għandhom struttura kimika differenti.
14 Changes in blood glucose levels have been known to result in transient visual disturbances, especially at the commencement of treatment.
Disturbi fl- għajnejn Rari ħafna: disturbi tal- vista Tibdiliet fil- livell tal- glucose fid- demm huma magħrufa li jirriżultaw f' disturbi tranżitorji tal- vista, speċjalment fil- bidu tal- kura.
5.1 Pharmacodynamic properties
16 5. 1 Tagħrif farmakodinamiku
Repaglinide is a novel short-acting oral secretagogue.
Repaglinide huwa prodott ġdid li jikkawża s- sekrezzjoni ta ’ l- insulina, jittieħed mill- ħalq u jaħdem għal ħin qasir.
15 treated patients as compared to sulfonylurea treated patients (see sections 4.4 and 4.8).
Studju epidemjoloġiku wieħed wera żieda fir- riskju tas- sindromu koronarju akut f’ pazjenti kkurati b’ repaglinide meta mqabbla ma ’ pazjenti kkurati b’ sulfonylureas (ara sezzjonijiet 4. 4 u 4. 8).
Repaglinide is almost completely metabolised, and no metabolites with clinically relevant hypoglycaemic effect have been identified.
17 Repaglinide jiġi metabolizzat kważi kollu, u ma ġewx identifikati metaboli b' effett ipogliċemiku ta ’ rilevanza klinika.
Repaglinide and its metabolites are excreted primarily via the bile.
Repaglinide u l- metaboli tiegħu jiġu mneħħija primarjament permezz tal- bile.
Microcrystalline cellulose (E460) Calcium hydrogen phosphate, anhydrous Maize starch Amberlite (polacrilin potassium) Povidone (polyvidone) Glycerol 85% Magnesium stearate Meglumine Poloxamer Iron oxide, yellow (E172)
Microcrystalline cellulose (E460) Calcium hydrogen phosphate, anhydrous Maize starch Amberlite (polacrilin potassium) Povidone (polyvidone) Glycerol 85% Magnesium stearate Meglumine Poloxamer
16 Not applicable.
Ma jgħoddx f’ dan ’ il- każ.
Novo Nordisk A/ S Novo Allé DK-2880 Bagsværd Denmark
Novo Nordisk A/ S DK- Novo Alle '2880 Bagsværd Id- Danimarka
NovoNorm 2 mg tablets
NovoNorm 2 mg pilloli
Each tablet contains 2 mg of repaglinide.
Kull pillola fiha 2 mg ta ’ repiglinide.
Repaglinide tablets are peach-coloured, round and convex and engraved with Novo Nordisk logo (Apis bull).
Il- pilloli ta ’ repaglinide huma kulur il- ħawħa, tondi u konvessi u inċiżi bil- logo Novo Nordisk (Apis bull).
In the case of concomitant use with other active substances refer to sections 4.4 and 4.5 to assess dosage.
F’ każ ta ’ użu fl- istess ħin ta ’ sustanzi attivi oħra irreferi għal sezzjonijiet 4. 4 u 4. 5 biex tiċċekkja d - dożaġġ.
Initial dose The dosage should be determined by the physician, according to the patient’ s requirements.
20 Doża inizjali Id- doża għandha tiġi determinata mit- tabib, skond il- ħtiġijiet tal- pazjent.
18 If patients are transferred from another oral hypoglycaemic agent the recommended starting dose is 1 mg.
Jekk pazjenti jiġu trasferiti minn sustanza orali oħra li tbaxxi l- livell ta ’ glucose fid- demm, huwa rakkomandat li l- kura għandha tibda b’ doża ta ’ 1 mg.
Repaglinide like other insulin secretagogues, is capable of producing hypoglycaemia.
21 Repaglinide bħas- sustanzi l- oħra li jikkawżaw is- sekrezzjoni ta ’ l- insulina, jista 'jikkawża ipogliċemija.
Repaglinide acts through a distinct binding site with a short action on the β -cells.
Repaglinide jaġixxi permezz ta ’ sit speċifiku ta ’ rabta b' azzjoni qasira fuq iċ- ċelloli β.
19 Trials investigating the combination with other insulin secretagogues and acarbose have not been performed.
Ma sarux studji kliniċi li jinvestigaw t- teħid tal- prodott flimkien ma 'prodotti oħra li jikkawżaw s- sekrezzjoni ta ’ l- insulina u ma ’ acarbose.
Possible interactions should therefore be taken into account by the physician:
Għalhekk, it- tabib għandu jikkunsidra l- interazzjonijiet possibbli.
Based on in vitro data, repaglinide appears to be a substrate for active hepatic uptake (organic anion transporting protein OATP1B1).
22 Minn informazzjoni in vitro, jidher li repaglinide huwa sustrat għall- assorbiment epatiku attiv (proteina organika għat- trasport anijoniku OATP1B1).
20 Co-administration of trimethoprim (160 mg twice daily), a moderate CYP2C8 inhibitor, and repaglinide (a single dose of 0.25 mg) increased the repaglinide AUC, Cmax and t½ (1.6-fold, 1.4-fold and 1.2-fold respectively) with no statistically significant effects on the blood glucose levels.
Meta repaglinide (doża waħda ta ’ 0. 25 mg) ingħata flimkien ma ’ trimethoprim( 160 mg darbtejn kuljum), inibitur moderat ta ’ CYP2C8, kien hemm żieda fl- AUC, fis- Cmax u fit- t½ (1. 6 darbiet, 1. 4 darbiet u 1. 2 darbiet rispettivament) ta ’ repaglinide, mingħajr ebda effett statistikament sinifikanti fuq il- livelli tal- glucose fid- demm.
Since the interaction has not been established with dosages higher than 0.25 mg for repaglinide, the concomitant use of ciclosporin with repaglinide should be avoided.
23 0. 25 mg, l- użu fl- istess ħin ta ’ ciclosporin u repagline għandu jiġi evitat.
When repaglinide is used together with other drugs that are mainly secreted by the bile, like
Meta repaglinide jintuża flimkien ma 'sustanzi oħra li prinċipalment ikollhom tnixxija biljari, bħal repaglinide, wieħed għandu jikkunsidra kull interazzjoni li tista ’ sseħħ.
If severe, requiring third party assistance, infusion of glucose may be necessary.
24 Jekk ikunu serji, tant li tkun meħtieġa l- assistenza minn persuni oħra, jista ’ jkun hemm bżonn infużjoni ta 'glucose.
Visual disturbances Changes in blood glucose levels have been known to result in transient visual disturbances, especially at the commencement of treatment.
Disturbi fl- għajnejn Rari ħafna: disturbi tal- vista Tibdiliet fil- livell tal- glucose fid- demm huma magħrufa li jirriżultaw f' disturbi tranżitorji tal- vista, speċjalment fil- bidu tal- kura.
5.1 Pharmacodynamic properties
25 5. 1 Tagħrif farmakodinamiku
23 One epidemiological study suggested an increased risk of acute coronary syndrome in repaglinide treated patients as compared to sulfonylurea treated patients (see sections 4.4 and 4.8).
Studju epidemjoloġiku wieħed wera żieda fir- riskju tas- sindromu koronarju akut f’ pazjenti kkurati b’ repaglinide meta mqabbla ma ’ pazjenti kkurati b’ sulfonylureas (ara sezzjonijiet 4. 4 u 4. 8).
Repaglinide is almost completely metabolised, and no metabolites with clinically relevant hypoglycaemic effect have been identified.
26 Repaglinide jiġi metabolizzat kważi kollu, u ma ġewx identifikati metaboli b' effett ipogliċemiku ta ’ rilevanza klinika.
Microcrystalline cellulose (E460) Calcium hydrogen phosphate, anhydrous Maize starch Amberlite (polacrilin potassium) Povidone (polyvidone) Glycerol 85% Magnesium stearate Meglumine Poloxamer Iron oxide, red (E172)
Microcrystalline cellulose (E460) Calcium hydrogen phosphate, anhydrous Maize starch Amberlite (polacrilin potassium) Povidone (polyvidone) Glycerol 85% Magnesium stearate Meglumine Poloxamer
24 Not applicable.
Ma jgħoddx f’ dan ’ il- każ.
27 ANNEX III
30 ANNESS III
29 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
32 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
NovoNorm 0.5 mg tablets Repaglinide
NovoNorm 0. 5 mg pilloli Repaglinide
Repaglinide 0.5 mg;
Repaglinide 0. 5 mg;
Glycerol 85% is one of the excipients
Glycerol 85% hu wieħed mis- sustanzi mhux attivi
30 tablets 90 tablets 120 tablets 270 tablets
30 pillola 90 pillola 120 pillola 270 pillola
Oral use
Għal użu orali.
Store in the original package
Aħżen fil- pakkett oriġinali.
31 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
34 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI
BLISTER FOIL
FOJL TAL- FOLJI
32 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
35 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
NovoNorm 1 mg tablets Repaglinide
NovoNorm 1 mg pilloli Repaglinide
34 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
37 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI
NovoNorm 2 mg tablets Repaglinide
NovoNorm 2 mg pilloli Repaglinide
37 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
40 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI
39 PACKAGE LEAFLET:
42 FULJETT TA ’ TAGĦRIF:
NovoNorm 0.5 mg tablets 1 mg tablets 2 mg tablets
NovoNorm Pilloli ta ’ 0. 5 mg Pilloli ta ’ 1 mg Pilloli ta ’ 2 mg
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Jekk xi wieħed mill- effetti sekondarji jiggrava, jew jekk tinnota xi effetti sekondarji li m’ humiex imsemmijin f’ dan il- fuljett, jekk jogħġbok għid lit- tabib jew lill- ispiżjar tiegħek.
What NovoNorm is and what it is used for 2.
X’ inhu NovoNorm u għalxiex jintuża 2.
Before you take NovoNorm 3.
Qabel ma tieħu NovoNorm 3.
How to take NovoNorm 4.
Kif għandek tieħu NovoNorm 4.
How to store NovoNorm 6.
Kif taħżen NovoNorm 6.
WHAT NOVONORM IS AND WHAT IT IS USED FOR
X’ INHU NOVONORM U GĦALXIEX JINTUŻA
NovoNorm is an oral antidiabetic agent containing repaglinide which helps your pancreas produce more insulin and thereby lower your blood sugar (glucose).
NovoNorm hu sustanza orali kontra d- dijabete li fih repaglinide, li jgħin il- frixa tiegħek tipproduċi iżjed insulina u b’ hekk tnaqqas il- livell taż- żokkor (glucose) fid- demm.
Type 2 diabetes is a disease in which your pancreas does not make enough insulin to control the sugar in your blood or where your body does not respond normally to the insulin it produces (formerly known as non-insulin-dependent diabetes mellitus or maturity onset diabetes).
Id- dijabete ta ’ tip 2 hija marda fejn l- frixa tiegħek ma tagħmilx insulina biżżejjed biex ikun ikkontrollat il- livell taz- zokkor fid- demm tiegħek jew fejn il- ġisem tiegħek ma jirrispondix b’ mod normali għall- insulina li tipproduċi (magħrufa qabel bħala dijabete mellitus li m’ hijiex dipendenti fuq l- insulina jew dijabete ta ’ l- adulti.
NovoNorm is used to control type 2 diabetes as an add-on to diet and exercise: treatment is usually started if diet, exercise and weight reduction alone have not been able to control (or lower) your blood sugar.
NovoNorm jintuża bħala żieda mad- dieta u l- eżerċizzju biex tiġi ikkontrollata d- dijabete tat- tip 2: normalment il- kura tinbeda jekk id- dieta, l- eżerċizzju u t- tnaqqis fil- piż waħidhom ma kinux kapaċi jikkontrollaw (jew inaqqsu) il- livelli taz- zokkor fid- demm tiegħek.