qanastek/EMEA-V3 huggingface dataset:
In contrast, patients adding placebo to their existing treatment showed smaller changes in HbA1c levels, ranging from a fall of 0.3% to a rise of 0.2%.
B’ kuntrast għal dan, fil- pazjenti li kienu żdiedu l- plaċebo mat- trattament eżistenti ġew osservati bidliet ta ’ entità iżgħar tal- livell ta ’ HbA1c, bejn tnaqqis ta ’ 0. 3% u żieda ta ’ 0. 2%.
Although adding Jalra to existing insulin therapy caused a greater reduction in HbA1c levels than placebo, the size of this effect was too small to be considered meaningful for patients.
Minkejja ż- żieda ta ’ Jalra mal- terapija bl- insulina eżistenti kkawżat tnaqqis akbar tal- livelli ta ’ HbA1c meta mqabbla mal- plaċebo, l- entità ta ’ dan l- effett kienet żgħira wisq biex titqies sinifikanti għall - pazjenti.
The company withdrew its application for the use of Jalra on its own and as an add-on to insulin during the assessment of the medicine.
Matul il- valutazzjoni tal- mediċina, il- kumpanija irtirat l- applikazzjoni tagħha għall- użu ta ’ Jalra waħdu u bħala żieda mal- insulina.
What is the risk associated with Jalra?
X’ inhu r- riskju assoċjat ma ’ Jalra?
The most common side effect with Jalra (seen in between 1 and 10 patients in 100) is dizziness.
L- effett sekondarju l- aktar komuni b’ Jalra (li deher f’ bejn pazjent 1 u 10 minn 100) kien sturdament.
For the full list of all side effects reported with Jalra, see the Package Leaflet.
Għal- lista sħiħa tal- effetti sekondarji rrappurtati b’ Jalra, ara l- Fuljett ta ’ Tagħrif.
Jalra should not be used in people who may be hypersensitive (allergic) to vildagliptin or any of the other ingredients.
Jalra ma għandux jintuża f’ persuni li jistgħu jkunu ipersensittivi (allerġiċi) għal vildagliptin jew għal xi ingredjent ieħor tiegħu.
Its use in patients with heart disease should be limited to patients with mild disease.
L- użu tiegħu f’ pazjenti li jbatu minn mard tal- qalb għandu jkun limitat għal dawk b’ mard ħafif.
Because vildagliptin has been associated with liver problems, patients should have tests to check their liver before treatment with Jalra and at regular intervals during treatment.
Billi vildagliptin kien assoċjat ma ’ problemi fil- fwied, il- pazjenti għandhom jagħmlu testijiet tal- fwied qabel it- trattament b’ Jalra u f’ intervalli regolari matul it- trattament.
Why has Jalra been approved?
Għaliex ġie approvat Jalra?
The Committee for Medicinal Products for Human Use (CHMP) concluded that Jalra’ s benefits in the treatment of type 2 diabetes mellitus are greater than its risks when used as dual oral therapy in combination with metformin, a sulphonylurea or a thiazolidinedione.
Il- Kumitat għall- Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) ikkonkluda li l- benefiċċji ta ’ Jalra fit- trattament tad- dijabete mellitu tat- 2 tip huma ogħla mir- riskji tiegħu meta użat bħala terapija dupliċi orali flimkien mal- metformina, sulfonilurea jew thiazolidinedione.
The Committee recommended that Jalra be given marketing authorisation.
Il- Kumitat irrakkomanda li Jalra jingħata awtorizzazzjoni għat- tqegħid fis- suq.
Other information about Jalra:
Aktar tagħrif dwar Jalra:
The European Commission granted a marketing authorisation valid throughout the EU for Jalra to Novartis Europharm Limited on 19 November 2008.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fis- suq valida fl- Unjoni Ewropea kollha għal Jalra lil Novartis Europharm Limited fil- 19 ta ’ Novembru 2008.
The full EPAR for Jalra can be found here.
L- EPAR sħiħ għal Jalra jista ’ jiġi kkonsultat hawn.
Jalra 50 mg tablets
Jalra 50 mg pilloli
Jalra can be administered with or without a meal (see also section 5.2).
Glavus jista ’ jingħata ma ’ ikla jew waħdu (ara wkoll sezzjoni 5. 2).
Additional information on special populations 2 Renal impairment No dose adjustment is required in patients with mild renal impairment (creatinine clearance ≥ 50 ml/ min).
2 M’ hemmx bżonn ta ’ aġġustamenti fid- doża f’ pazjenti b’ indeboliment ħafif renali (tneħħija tal - krejatinina ≥ 50 ml/ min).
The use of Jalra is not recommended in patients with moderate or severe renal impairment or in haemodialysis patients with end-stage renal disease (ESRD) (see also sections 4.4 and 5.2).
L- użu ta ’ Jalra mhux rakkomandat f’ pazjenti b’ indeboliment renali moderat jew sever jew pazjenti fuq emodijalisi b’ mard renali fl- aħħar stadju (ESRD) (ara wkoll sezzjonijiet 4. 4 u 5. 2).
Hepatic impairment Jalra should not be used in patients with hepatic impairment, including patients with pre-treatment alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 3x the upper limit of normal (ULN) (see also sections 4.4 and 5.2).
Indeboliment tal- fwied Jalra mgħandux jintuża f’ pazjenti b’ indeboliment tal- fwied, inklużi pazjenti li jkollhom alanine aminotransferase (ALT) jew aspartate aminotransferase (AST) qabel il- kura > 3 darbiet il- limitu ta ’ fuq tan- normal (ULN) (ara wkoll sezzjonijiet 4. 4 u 5. 2).
Paediatric population (< 18 years) Jalra is not recommended for use in children and adolescents due to a lack of data on safety and efficacy.
Popolazzjoni pedjatrika (< 18- il sena) Jalra mhux irrakkomandat għall- użu fit- tfal u adolexxenti peress li m’ hemmx biżżejjed informazzjoni dwar is- sigurtà u l- effikaċja.
General Jalra is not a substitute for insulin in insulin-requiring patients.
Ġenerali Jalra mhux sostitut ta ’ l- insulina f’ pazjenti li jeħtieġu l- insulina.
Jalra should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis.
Jalra m’ għandux jintuża f’ pazjenti b’ dijabete tat- tip 1 jew għall- kura ta ’ ketoaċidożi dijabetika.
Therefore, the use of Jalra is not recommended in these patients.
Għalhekk, l- użu ta ’ Jalra mhux rakkomandat f’ dawn il- pazjenti.
Hepatic impairment Jalra should not be used in patients with hepatic impairment, including patients with pre-treatment ALT or AST > 3x ULN.
Indeboliment tal- fwied Jalra mgħandux jintuża f’ pazjenti b’ indeboliment tal- fwied, inklużi pazjenti li jkollhom ALT jew AST qabel il- kura ta > 3 darbiet l- ULN.
Liver function tests should be performed prior to the initiation of treatment with Jalra in order to know the patient’ s baseline value.
It- testijiet tal- funzjoni tal- fwied għandhom isiru qabel ma tinbeda l- kura b’ Jalra sabiex ikun magħruf il- valur tal- linja bażi tal- pazjent.
Liver function should be monitored during treatment with Jalra at three-month intervals during the first year and periodically thereafter.
Il- funzjoni tal- fwied għandha tiġi monitorata waqt il- kura b’ Jalra f’ intervalli ta ’ tlett xhur fl- ewwel sena u darba kulltant minn hemm ’ l quddiem.
Should an increase in AST or ALT of 3x ULN or greater persist, withdrawal of Jalra therapy is recommended.
Jekk żieda fl- AST jew ALT ta ’ 3 darbiet il- ULN jew aktar jippersisti, huwa rakkomandat li t- terapija b’ Jalra titwaqqaf.
Patients who develop jaundice or other signs suggestive of liver dysfunction should discontinue Jalra.
Pazjenti li jiżviluppaw is- suffejra jew sinjali li jindikaw funzjoni anormali tal- fwied għandhom iwaqqfu Jalra.
Following withdrawal of treatment with Jalra and LFT normalisation, treatment with Jalra should not be reinitiated.
Wara t- twaqqif tal- kura b’ Jalra u LFT ikun ġie lura għan- normal, il- kura b’ Jalra mgħandhiex terġa tinbeda.
Cardiac failure Experience with vildagliptin therapy in patients with congestive heart failure of New York Heart Association (NYHA) functional class I-II is limited and therefore vildagliptin should be used
Insuffiċejnza kardijaka
3 cautiously in these patients.
3 L- esperjenza b’ terapija ta ’ vildagliptin f’ pazjenti b’ insuffiċjenza tal- qalb konġestiva ta ’ klassi funzjonali ta ’ l- Assoċjazzjoni Tal- Qalb ta ’ New York (NYHA) I- II hija limitata u għalhekk vildagliptin għandu jintuża b’ attenzjoni f’ dawn il- pazjenti.
Due to lack of human data, Jalra should not be used during pregnancy.
Minħabba nuqqas ta ’ dejta fil- bniedem, Jalra m’ għandux jintuża waqt it- tqala.
It is not known whether vildagliptin is excreted in human breast milk.
Mhux magħruf jekk Jalra joħroġx mal- ħalib tal- mara.
Jalra should not be used during lactation.
Jalra m’ għandux jintuża waqt it- treddigħ.
Of these patients, 2,264 patients received vildagliptin as monotherapy and
4 Tagħrif dwar is- sigurtà inkiseb minn 3, 784 pazjent espost għal vildagliptin b’ doża ta ’ 50 mg kuljum (darba kuljum) jew 100 mg (50 mg darbtejn kuljum jew 100 mg darba kuljum) fi provi kliniċi kontrollati li damu mill- anqas 12- il ġimgħa.
4 1,520 patients received vildagliptin in combination with another medicinal product.
Minn dawn, 2, 264 pazjent rċievew vildagliptin waħdu u 1, 520 pazjent rċievew vildagliptin f’ kombinazzjoni ma ’ prodott mediċinali ieħor.
In data from controlled monotherapy and add-on therapy trials of up to 24 weeks in duration, the incidence of ALT or AST elevations  3x ULN (classified as present on at least 2 consecutive measurements or at the final on-treatment visit) was 0.2%, 0.3% and 0.2% for vildagliptin 50 mg once daily, vildagliptin 50 mg twice daily and all comparators, respectively.
Minn dejta minn monoterapija kontrollata u provi add- on li damu sa 24 ġimgħa, l- inċidenza ta ’ żiediet fl- ALT jew AST kienet  3 darbiet ULN (klassifikata bħala preżenti f’ mill- anqas 2 kejliet wara xulxin jew fl- aħħar żjara fuq il- kura) kienu 0. 2%, 0. 3% u 0. 2% għal vildagliptin 50 mg kuljum, vildagliptin 50 mg darbtejn kuljum u l- kumparaturi kollha, rispettivament.
Adverse reactions reported in patients who received Jalra in double-blind studies as monotherapy and add-on therapies are listed below for each indication by system organ class and absolute frequency.
Reazzjonijiet avversi rrappurtati f’ pazjenti li rċievew Jalra fi studji double blind bħala monoterapija u terapiji miżjuda huma elenkati hawn taħt għall- kull indikazzjoni bil- klassi ta ’ l- organi tas- sistema u frekwenza assoluta.
Adverse reactions reported in patients who received Jalra 100 mg daily in combination with metformin in double-blind studies (N=208)
Tabella 1 Reazzjonijiet avversi rrappurtati f’ pazjenti li rċievew Jalra 100 mg kuljum ma ’ metformin fi studji double- blind (N=208)
5 In controlled clinical trials with the combination of vildagliptin 50 mg + a sulphonylurea, the overall incidence of withdrawals due to adverse reactions was 0.6% in the vildagliptin 50 mg + sulphonylurea vs 0% in the placebo + sulphonylurea treatment group.
Meta jittieħed flimkien ma ’ sulphonylurea Fi provi kliniċi bil- kontroll meta vildagliptin 50 mg ingħata ma ’ sulphonylurea, l- inċidenza globali tat - twaqqif minħabba reazzjonijiet avversi kienet 0. 6% fil- grupp ta ’ kura b’ vildagliptin 50 mg ma ’ sulphonylurea kontra 0% fil- grupp bil- plaċebo ma ’ sulphonylurea.
Adverse reactions reported in patients who received Jalra 50 mg in combination with a sulphonylurea in double-blind studies (N=170)
Tabella 2 Reazzjonijiet avversi rrappurtati f’ pazjenti li rċievew Jalra 100 mg kuljum ma ’ sulphonylurea fi studji double- blind (N=170)
In the pioglitazone add-on study, the absolute weight increases with placebo, Jalra 100 mg daily were 1.4 and 2.7 kg, respectively.
Fl- istudju biż- żieda ta ’ pioglitazone, il- piż assolut jiżdied bil- plaċebo u b’ Jalra 100 mg kuljum kienu 1. 4 u 2. 7 kg rispettivament.
Adverse reactions reported in patients who received Jalra 100 mg daily in combination with a thiazolidinedione in double-blind studies (N=158)
Tabella 3 Reazzjonijiet avversi rrappurtati f’ pazjenti li rċievew Jalra 100 mg flimkien ma ’ thiazolidinedione fi studji double- blind (N=158)
6 In addition, in controlled monotherapy trials with vildagliptin the overall incidence of withdrawals due to adverse reactions was no greater for patients treated with vildagliptin at doses of 100 mg daily (0.3%) than for placebo (0.6%) or comparators (0.5%).
Minbarra hekk, fi provi kontrollati b’ monoterapija b’ vildagliptin, l- inċidenza globali ta ’ dawk li kellhom iwaqqfuh minħabba reazzjonijiet avversi ma kienitx akbar għal pazjenti ikkurati b’ vildagliptin b’ dożi ta ’ 100 mg kuljum (0. 3%) milli għall- plaċebo (0. 6%) jew kumparaturi (0. 5%).
Adverse reactions reported in patients who received Jalra 100 mg daily as monotherapy in double-blind studies (N=1,855)
Tabella 4 Reazzjonijiet avversi rrappurtati f’ pazjenti li rċievew Jalra 100 mg kuljum bħala monoterapija fi studji double- blind (N=1, 855)
Information on the likely symptoms of overdose was taken from a rising dose tolerability study in healthy subjects given Jalra for 10 days.
L- informazzjoni dwar x’ aktarx li jkunu s- sintomi ta ’ doża eċċessiva inkisbu minn studju dwar it - tolleranza għal doża ta ’ Jalra miżjuda mogħtija lill- individwi b’ saħħithom għal 10 ijiem.
Management In the event of an overdose, supportive management is recommended.
Maniġġar F’ każ ta ’ doża eċċessiva, huwa rakkomandat maniġġar ta ’ support.
7 The administration of vildagliptin results in a rapid and complete inhibition of DPP-4 activity, resulting in increased fasting and postprandial endogenous levels of the incretin hormones GLP-1 (glucagon-like peptide 1) and GIP (glucose-dependent insulinotropic polypeptide).
7 L- għotja ta ’ vildagliptin twassal għal impediment mgħaġġel u komplet ta ’ l- attività DPP- 4, li twassal għal livelli endoġeni ogħla ta ’ waqt is- sawm u wara l- ikel ta ’ ormoni inkretin GLP- 1 (peptidu 1 li jixbah il- glukagon) u GIP (polypeptidu insulinotropiku dipendenti fuq glucose).
Treatment with vildagliptin 50-100 mg daily in patients with type 2 diabetes significantly improved markers of beta cell function including HOMA- (Homeostasis Model Assessment–), proinsulin to insulin ratio and measures of beta cell responsiveness from the frequently-sampled meal tolerance test.
Kura b’ vildagliptin 50- 100 mg kuljum f’ pazjenti bid- dijabete tat- tip 2 tejbet b’ mod sinifikanti l- markaturi tal- funzjoni taċ- ċelluli beta inkuż HOMA-  (Evalwar-  tal- Mudell ta ’ Omejostażi), proporzjon tal- pro- insulina ma ’ l- insulina u l- kejl ta ’ kemm juru rispons iċ- ċelluli beta mit- test tat - tolleranza li jieħu ħafna kampjuni.
Overall, vildagliptin improved glycaemic control when given as monotherapy or when used in combination with metformin, a sulphonylurea, and a thiazolidinedione, as measured by clinically relevant reductions in HbA 1c from baseline at study endpoint (see Table 5).
B’ mod ġenerali, vildagliptin tejjeb il- kontroll gliċemiku meta ngħata bħala monoterapija jew meta ntuża f’ kombinazzjoni ma ’ metformin, sulphonylurea u thiazolidinedione kif imkejjel minn tnaqqis klinikament rilevanti fl- HbA 1c mill- linja bażi fl- endpoint ta ’ l- istudju (ara Tabella 5).
In clinical trials, the magnitude of HbA 1c reductions with vildagliptin was greater in patients with higher baseline HbA 1c.
Fi provi kliniċi, il- grad ta ’ tnaqqis fl- HbA 1c b’ vildagliptin kien akbar fil- pazjenti li kellhom HbA 1c ogħla fil- linja bażi.
In a 52-week double-blind controlled trial, vildagliptin (50 mg twice daily) reduced baseline HbA 1c by -1% compared to -1.6% for metformin (titrated to 2 g/ day) statistical non-inferiority was not achieved.
Fi prova double- blind kontrollata li damet 52- ġimgħa, vildagliptin (50 mg darbtejn kuljum) naqqas l - HbA 1c mill- linja bażi b ’ - 1% meta mqabbel ma ’ - 1. 6% għal metformin (miżjud għal 2 g/ jum) ma nstabx li ma kienx inferjuri b’ mod statistiku.
Patients treated with vildagliptin reported significantly lower incidences of gastrointestinal adverse reactions versus those treated with metformin.
Pazjenti kkurati b’ vildagliptin irrappurtaw effetti avversi gastro- intestinali b’ inċidenza aktar baxxa b’ mod sinifikanti kontra dawk ikkurati b’ metformin.
In a 24-week double-blind controlled trial, vildagliptin (50 mg twice daily) was compared to rosiglitazone (8 mg once daily).
Fi prova double- blind kontrollata li damet 24- ġimgħa, vildagliptin (50 mg darbtejn kuljum) kien imqabbel ma ’ rosiglitazone (8 mg darba kuljum).
Mean reductions were -1.20% with vildagliptin and -1.48% with rosiglitazone in patients with mean baseline HbA 1c of 8.7%.
Il- medji tat- tnaqqis kienu - 1. 20% b’ vildagliptin u - 1. 48% b’ rosiglitazone f’ pazjenti bil- linja bażi ta ’ HbA 1c ta ’ 8. 7%.
8 Table 5
8 Tabella 5
Placebo-
Il- bidla aġġustata
controlled studies
ta ’ plaċebo
baseline
HbA 1c fil -
corrected mean
bażi (%)
HbA
bażi fl- HbA 1c (%) ma ’
1c (%)
HbA 1c (%) ma ’
HbA 1c (%) at week 24
ġimgħa 24
change in HbA 1c (%) at week 24 (95%CI)
ġimgħa 24 (95% CI)
Administration of vildagliptin with food resulted in a decreased C max (19%).
L- għotja ta ’ vildagliptin ma ’ l - ikel wasslet għal tnaqqis fis- C max (19%).
However, the magnitude of change is not clinically significant, so that Jalra can be given with or without food.
Madankollu, id- daqs tal- bidla mhiex klinikament sinfikanti, b’ hekk Jalra jista ’ jingħata ma ’ l- ikel jew mingħajr ikel.
The mean volume of distribution of vildagliptin at steady-state after intravenous administration (V ss) is 71 litres, suggesting extravascular distribution.
Il- medja tal- volum tad- distribuzzjoni ta ’ vildagliptin fi stat fiss wara li jingħata minn ġol- vina (V ss) hija 71 litru, li jindika distribuzzjoni ekstravaskulari.
Accordingly, the metabolic clearance of vildagliptin is not anticipated to be affected by co-medications that are CYP 450 inhibitors and/ or inducers.
B’ hekk, it- tneħħija metabolika ta ’ vildagliptin mhux mistennija li teffettwa l- medikazzjonijiet li jingħataw miegħu li huma impedituri jew/ u indutturi ta ’ CYP 450.
Elimination Following oral administration of [14C] vildagliptin, approximately 85% of the dose was excreted into the urine and 15% of the dose is recovered in the faeces.
9 Eliminazzjoni Wara li [14C] vildagliptin jittieħed mill- ħalq, madwar 85% tad- doża kienet eskretata fl- awrina u 15% tad- doża kienet irkuprata fl- ippurgar.
The mean 9 elimination half-life after intravenous administration is approximately 2 hours.
Il- medja tal- half - life ta ’ l- eliminazzjoni wara li jingħata minn ġol- vina hija madwar sagħtejn.
Linearity / non-linearity The C max for vildagliptin and the area under the plasma concentrations versus time curves (AUC) increased in an approximately dose proportional manner over the therapeutic dose range.
Linearità / nuqqas ta linearità Is- C max ta ’ vildagliptin u l- erja taħt il- kurvi tal- konċentrazzjonijiet fil- plażma kontra l- ħin (AUC) żdiedet b’ mod kważi proporzjonali mad- doża fil- medda tad- doża terapewtika.
Renal impairment In subjects with mild, moderate, or severe renal impairment, systemic exposure to vildagliptin was increased (C max 8-66%; AUC 32-134%) and total body clearance was reduced compared to subjects with normal renal function.
Indeboliment renali F’ individwi b’ indeboliment renali ħafif, moderat jew sever, l- esponiment sistemiku għal vildagliptin kien miżjud (C max 8- 66%; AUC 32- 134%) u t- tneħħija totali mill- ġisem tnaqqset meta mqabbla ma ’ individwi b’ funzjoni renali normali.
Intra-cardiac impulse conduction delays were observed in dogs with a no-effect dose of 15 mg/ kg (7- fold human exposure based on C max).
Il- konduzzjoni ta ’ l- impulsi fil- qalb dehru ttardjati fi klieb b’ doża mingħajr effett ta ’ 15 mg/ kg (7 - darbiet l- esponiment fil- bniedem ibbażat fuq is- C max).
Gastrointestinal symptoms, particularly soft faeces, mucoid faeces, diarrhoea and, at higher doses, faecal blood were observed in dogs.
Sintomi gastro- intestinali, l- aktar ippurgar artab, ippurgar bi żlieġa, dijarea u, b’ dożi ogħla, demm fl - ippurgar dehru fi klieb.
A fertility and early embryonic development study in rats revealed no evidence of impaired fertility, reproductive performance or early embryonic development due to vildagliptin.
10 Studju dwar il- fertilità u l- ewwel żvilupp ta ’ l- embriju fil- firien wera li mhemmx tixkil fil- fertilità, ħila ta ’ riproduzzjoni jew l- ewwel żvilupp ta ’ l- embriju minn vildagliptin.
In rabbits, decreased foetal weight and skeletal variations indicative of developmental delays were noted only in the presence of severe maternal toxicity, with a no-effect
Inċidenza akbar ta ’ kustilji mbewqa dehret fil- firien b’ mod assoċjat ma ’ tnaqqis fil- parametri tal- piż tal- ġisem ta ’ l- omm, b’ doża mingħajr effett ta ’ 75 mg/ kg (10 - darbiet l- esponiment fil- bniedem).
10 dose of 50 mg/ kg (9-fold human exposure).
Fil- fniek, tnaqqis fil- piż tal- fetu u bidliet fl- għadam li jindikaw ittardjar fl- iżvilupp dehru biss fil- preżenza ta ’ tossiċità severa għall- omm, b’ doża mingħajr effett ta ’ 50 mg/ kg (9- darbiet l- esponiment fil- bniedem).
Not all pack sizes may be marketed.
Aluminium/ Aluminium (PA/ Al/ PVC // Al) folja Jiġi f’ pakketti li jkun fihom 7, 14, 28, 30, 56, 60, 90, 112, 180 jew 336 pillola u f’ pakketti b’ hafna li jkollhom 336 (3x112) pilloli.
11 7.
11 Jista ’ jkun li mhux il- pakketti tad- daqsijiet kollha jkunu għall- skop kummerċjali.
MARKETING AUTHORISATION HOLDER
L- ebda ħtiġijiet speċjali.
Pharmacovigilance system The MAH must ensure that the system of pharmacovigilance, as described in version 3.0 presented in Module 1.8.1. of the Marketing Authorisation Application, is in place and functioning before and whilst the product is on the market.
Sistema ta ’ farmakoviġilianza L- MAH għandu jaċċerta ruħu li is- sistema ta ’ farmakoviġilanza, kif deskritta fil- verżjoni 3. 0 preżentata f’ Modulu 1. 8. 1 ta ’ l- Applikazzjoni għall- Awtorizzazzjoni għat- Tqegħid fis- Suq, tkun f’ lokha u taħdem qabel u waqt li l- prodott ikun fis- suq.
PSURs The PSUR cycle of Jalra will correspond to the one attributed to the cross-referred product, Galvus, until otherwise specified.
PSURs Iċ- ċiklu tal- PSUR ta ’ Jalra se jkun jikkorispondi ma ’ dak attribwit għall- prodott cross- referred, Galvus sakemm ma jiġix speċifikat mod ieħor.
Jalra 50 mg tablets vildagliptin
Jalra 50 mg pilloli vildagliptin
Jalra 50 mg tablets Vildagliptin
Jalra 50 mg pilloli Vildagliptin
What Jalra is and what it is used for 2.
X’ inhu Jalra u għalxiex jintuża 2.
Before you take Jalra 3.
Qabel ma tieħu Jalra 3.
How to take Jalra 4.
Kif għandek tieħu Jalra 4.
How to store Jalra 6.
Kif taħżen Jalra 6.
WHAT JALRA IS AND WHAT IT IS USED FOR
X’ INHU JALRA U GĦALXIEX JINTUŻA
Jalra belongs to a group of medicines called “ oral antidiabetics”.
Jalra jagħmel parti minn grupp ta ’ mediċini li jissejħu “ antidijabetiċi orali ”.
Jalra is used to treat patients with type 2 diabetes.
Jalra jintuża biex jikkura pazjenti b’ dijabete tat- tip 2.
Jalra works by making the pancreas produce more insulin and less glucagon.
Jalra jaħdem billi jġiegħel il- marrara tgħamel aktar insulina u anqas glukagon.
Your doctor will prescribe Jalra together with certain other antidiabetic medicines which you will already be taking to control diabetes, if one medicine alone is not enough to control your blood sugar level.
I- tabib tiegħek ser jordnalek Jalra flimkien ma ’ ċerti mediċini oħra kontra d- dijabete li diġa kont qed tieħu biex tikkontrolla d- dijabete, jekk mediċina waħda ma tkunx biżżejjed biex tikkontrolla il- livell taz- zokkor fid- demm tiegħek.
BEFORE YOU TAKE JALRA
QABEL MA TIEĦU JALRA
Further information).
Tieħux Jalra  jekk inti allerġiku/ a (tbati minn sensittività eċċessiva) għal vildagliptin jew sustanzi oħra ta ’ Jalra (ara sezzjoni 6 għal aktar tagħrif).
If you think you may be allergic to vildagliptin or any of the other ingredients of Jalra, do not take this medicine and talk to your doctor.
Jekk taħseb li tista ’ tkun allerġiku/ a għal vildagliptin jew kwalunkwe sustanza oħra ta ’ Jalra, tieħux din il- mediċina u tkellem mat- tabib tiegħek.
Take special care with Jalra:
25 Oqgħod attent ħafna b’ Jalra:
25  if you have type 1 diabetes (i. e. your body does not produce insulin).  if you have moderate or severe kidney disease.  if you are on dialysis.  if you have liver disease.  if you suffer from heart failure.
Jekk xi wieħed minn dawn jgħodd għalik, għid lit- tabib tiegħek qabel tieħu Jalra.  jekk għandek dijabete tat- tip 1 (i. e. jekk ġismek ma jipproduċix insulina).  jekk għandek mard moderat jew serju tal- kliewi.  jekk qiegħed/ qiegħda fuq dijalisi.  jekk għandek mard tal- fwied.  jekk għandek insuffiċjenza tal- qalb.
If you have previously taken Jalra but had to stop taking it because of side effects (liver disease), you should not take Jalra again.
Jekk xi darba hadt Jalra iżda kellek twaqqfu minħabba l- effetti sekondarji (mard tal- fwied), m’ għandekx terġa tieħu Jalra mill- ġdid.
You are also advised to pay particular attention to new onset of blisters or ulcers while taking Jalra.
Għandek ukoll toqgħod attent b’ mod partikolari għal bżieżaq jew ulċeri li jitfaċċaw meta tkun qed tieħu Jalra.
The use of Jalra in children and adolescents is not recommended.
L- użu ta ’ Jalra fi tfal u adolexxenti mhux rakkomandat.
Your doctor may wish to alter your dose of Jalra if you are taking other medicines (such as medicines so called thiazides, corticosteroids, thyroid products and certain products affecting the nervous system).
Jista ’ jkun li t- tabib tiegħek ikun jixtieq jibdillek id- doża tiegħek ta ’ Jalra jekk qed tieħu mediċini oħrajn (bħal mediċini hekk imsejjħa tajażajds, kortikosterojdi, prodotti tat- tirojde u ċerti prodotti li jeffettwaw is- sistema nervuża).
Taking Jalra with food and drink You can take Jalra with or without food.
Meta tieħu Jalra ma ’ l- ikel u max- xorb Tista ’ tieħu Jalra ma ’ l- ikel jew mingħajr ikel.
Pregnancy and breast-feeding Women who are pregnant or plan to become pregnant should consult their doctor before taking Jalra.
Tqala u Treddigħ Nisa li ħarġu tqal jew qed jaħsbu għat- tqala għandhom jikkonsultaw mat- tabib tagħhom qabel ma jieħdu Jalra.
You should not use Jalra during pregnancy.
M’ għandekx tuża Jalra waqt it- tqala.
It is not known if Jalra passes into breast milk.
Mhux magħruf jekk Jalra jgħaddix mal- ħalib tas- sider.
You should not use Jalra if you are breast-feeding or plan to breast-feed.
M’ għandekx tuża Galvux jekk qed tredda ’ jew qed taħseb biex tredda ’.
Driving and using machines If you feel dizzy while taking Jalra, do not drive or use machines.
Sewqan u tħaddim ta ’ magni Jekk tħossok sturdut meta tkun qed tieħu Jalra, m’ għandekx issuq jew tħaddem magni.
Important information about some of the ingredients of Jalra Jalra contains lactose (milk sugar).
Tagħrif importanti dwar xi wħud mis- sustanzi ta ’ Jalra Jalra fih lactose (zokkor tal- ħalib).
HOW TO TAKE JALRA
KIF GĦANDEK TIEĦU JALRA
Always take Jalra exactly as your doctor has told you.
Dejjem għandek tieħu Jalra skond il- parir tat- tabib.
How much to take The amount of Jalra people have to take varies depending on their condition.
Kemm għandek tieħu L- ammont ta ’ Jalra li għandhom jieħdu n- nies tvarja skond il- kundizzjoni tagħhom.
Your doctor will tell you exactly how many tablets of Jalra to take.
It- tabib tiegħek sejjer jgħidlek eżattament kemm għandek tieħu pilloli Jalra.
The usual dose of Jalra is either:  50 mg daily taken as one dose in the morning if you are taking Jalra with another medicine called a sulphonylurea, or  100 mg daily taken as 50 mg in the morning and 50 mg in the evening if you are taking Jalra with another medicine called metformin or a glitazone.
Id- doża tas- soltu hija:  50 mg kuljum li tittieħed bħala doża waħda filgħodu jekk qed tieħu Jalra ma ’ mediċina oħra li tissejjaħ sulphonylurea, jew  100 mg kuljum li tittieħed bħala 50 mg filgħodu u 50 mg filgħaxija jekk qed tieħu Jalra ma ’ mediċina oħra li tissejjaħ metformin jew xi glitazone.
26 Your doctor will prescribe Jalra together with another medicine to control your blood sugar level.
26 It- tabib tiegħek sejjer jordnalek Jalra ma ’ mediċina oħra biex tikkontrolla l- livell taz- zokkor fid- demm tiegħek.
When and how to take Jalra  Take this medicine in the morning or in the morning and evening.  Swallow the tablets whole with some water.
Meta u kif għandek tieħu Jalra  Ħu din il- mediċina filgħodu jew filgħodu u filgħaxija.  Ibla ’ l- pilloli sħaħ bi ftit ilma.
How long to take Jalra  Take Jalra every day for as long as your doctor tells you.
Kemm għandek iddum tieħu Jalra  Ħu Jalra kuljum sakemm jgħidlek it- tabib tiegħek.
You may have to take this treatment over a long period of time.  Your doctor will regularly monitor your condition to check that the treatment is having the desired effect.  Do not stop taking Jalra unless your doctor tells you to.
Jista ’ jkollok bżonn tieħu din il- kura fuq perijodu twil ta ’ żmien.  It- tabib tiegħek sejjer jimmontora l- kundizzjoni tiegħek sabiex jara li l- kura qed ikollha l- effett mixtieq.  Tieqafx tieħu Jalra sakemm it- tabib tiegħek ma jgħidlekx biex tagħmel hekk.
If you take more Jalra than you should If you take too many Jalra tablets, or if someone else has taken your medicine, talk to your doctor straight away.
Jekk tieħu Jalra aktar milli suppost Jekk tieħu wisq pilloli Jalra jew jekk xi ħadd ieħor ħa l- mediċina tiegħek, tkellem mat- tabib tiegħek mill- ewwel.
If you need to see a doctor or go to the hospital, take the pack with you.
Jekk ikollok bżonn tara tabib jew tmur l - isptar, ħu l- pakkett miegħek.
If you forget to take Jalra If you forget to take a dose of this medicine, take it as soon as you remember.
Jekk tinsa tieħu Jalra Jekk tinsa tieħu doża ta ’ din il- mediċina, ħudha malli tiftakar.
Like all medicines, Jalra can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, Jalra jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
You should stop taking Jalra and see your doctor immediately if you experience the following side effects:  Angioedema (rare):
Għandek tieqaf tieħu Jalra u tara t- tabib tiegħek immedjatament jekk qed tħoss l- effetti sekondarji li ġejjin:  Anġjoedema (rari):
Other side effects Some patients have had the following side effects while taking Jalra and metformin:  Common:
Effetti sekondarji oħrajn Xi pazjenti kellhom dawn l- effetti sekondarji waqt li kienu qed jieħdu Jalra u metformin:  Komuni:
Some patients have had the following side effects while taking Jalra and a sulphonylurea:  Common:
Xi pazjenti kellhom dawn l- effetti sekondarji waqt li kienu qed jieħdu Jalra u sulphonylurea:  Komuni:
Constipation  Very rare:
Tregħid, uġigħ ta ’ ras, sturdament, dgħjufija, zokkor fid- demm baxx  Mhux komuni:
Sore throat, runny nose
Stitikezza
27 Some patients have had the following side effects while taking Jalra and a glitazone:  Common:
Grieżem misluħin, imnieħer inixxi
Some patients have had the following side effects while taking Jalra alone:  Common:
Xi pazjenti kellhom l- effetti sekondarji li ġejjin meta ħadu Jalra waħdu:  Komuni:
HOW TO STORE JALRA
KIF TAĦŻEN JALRA
 Keep out of the reach and sight of children.  Do not use Jalra after the expiry date which is stated on the blister and the carton.
 Żommu fejn ma jintaħaqx u ma jidhirx mit- tfal.  Tużax Jalra wara d- data ta ’ skadenza li tidher fuq il- folja u l- kartuna.
The expiry date refers to the last day of that month.  Store in the original package in order to protect from moisture.  Do not use any Jalra pack that is damaged or shows signs of tampering.
Id- data ta ’ skadenza tirreferi għall- aħħar ġurnata ta ’ dak ix- xahar.  Aħzen fil- pakkett oriġinali sabiex tilqa ’ mill- umdità.  Tuża l- ebda pakkett ta ’ Jalra li jkun danneġġjat jew li juri sinjali ta ’ tbabis.
What Jalra contains  The active substance is vildagliptin.
X’ fih Jalra  Is- sustanza attiva hi vldagliptin.
What Jalra looks like and contents of the pack Jalra 50 mg tablets are round, white to light yellowish and flat, with “ NVR” on one side and “ FB” on the other.
Id- Dehra ta ’ Jalra u l- kontenuti tal- pakkett Jalra 50 mg pilloli huma tondi, bojod jagħtu fl- isfar ċar u ċatti, b ’ “ NVR ” fuq naħa u “ FB ” fuq l- oħra.
Jalra 50 mg tablets are available in packs containing 7, 14, 28, 30, 56, 60, 90, 112, 180 or 336 tablets and in multipacks containing 336 (3x112) tablets.
Jalra 50 mg pilloli jiġu f’ pakketti li jkun fihom 7, 14, 28, 30, 56, 60, 90, 112, 180 jew 336 pillola u f’ pakketti b’ hafna li jkollhom 336 (3x112) pilloli.
28 België/ Belgique/ Belgien Novartis Pharma N. V.
28 Luxembourg/ Luxemburg België/ Belgique/ Belgien Novartis Pharma GmbH Novartis Pharma N. V.
Suomi/ Finland Novartis Finland Oy Puh/ Tel: +358 9 61 33 22 11
Puh/ Tel: +358 9 61 33 22 11
What is Janumet?
X’ inhu Janumet?
Janumet is a medicine containing two active substances, sitagliptin and metformin hydrochloride.
Janumet hija mediċina li fiha ż- żewġ sustanzi attivi sitagliptin u metformin hydrochloride.
What is Janumet used for?
Għal x' hiex jintuża Janumet?
Janumet is used to treat patients with type 2 diabetes, to improve control of blood sugar levels.
Janumet jintuża għat- trattament ta 'pazjenti b' dijabete tat- tip 2, sabiex ittejjeb il- kontroll tal- livelli taz - zokkor fid- demm.
How is Janumet used?
Kif jintuża Janumet?
Janumet is taken twice a day.
Janumet jiġi meħud darbtejn kuljum.
Patients already taking metformin, with or without a sulphonylurea, should take Janumet containing the same dose of metformin.
Pazjenti li diġa ’ jieħdu l - metformina flimkien jew mingħajr sulfonilurea għandhom jieħdu l- Janumet li fiha l- istess doża ta ’ metformina.
Patients already taking sitagliptin and metformin as separate tablets should switch to Janumet containing the same doses of both active substances.
Pazjenti li diġa ’ qed jieħdu sitagliptin u metformina bħala pilloli separate għandhom jaqilbu għal Janumet li fiha l- istess dożi taż- żewġ sustanzi attivi.
If Janumet is taken with a sulphonylurea, the dose of the sulphonylurea may need to be lowered, to avoid hypoglycaemia (low blood sugar levels).
Jekk Janumet jiġi meħud flimkien ma ’ sulfonilurea, id- doża ta ’ sulfonilurea jista ’ jkun meħtieġ li tiġi mnaqqsa sabiex tiġi evitata ipogliċemija (livelli baxxi ta ’ zokkor fid- demm).
Janumet should be taken with food to avoid any stomach problems caused by metformin.
Janumet għandu jiġi meħud ma ’ l- ikel sabiex jiġu evitati problemi ta ’ l- istonku ikkawwżati mill - metformina.
Janumet is not recommended for use in children under 18 years of age because of a lack of information on safety and effectiveness in this group.
Janumet ma huwiex rakkomandat sabiex jintuża fi tfal ta ’ inqas minn 18 – il sena, minħabba nuqqas ta ’ tagħrif fuq is- sigurtà u l- effikaċja f’ dan il- grupp.
How does Janumet work?
Kif jaħdem Janumet?
The active substances in Janumet, sitagliptin and metformin hydrochloride, each have a different mode of action.
Id- dijabete ta ’ Tip 2 hija marda li minħabba fiha, il- frixa ma tagħmilx biżżejjed insulina biex tikkontrolla l- livell ta ’ glukosju (zokkor) fid- demm jew meta l- ġisem ma jkunx jista ’ juża l- insulina b’ mod effettiv.
It works by blocking the breakdown of 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
Is- sustanzi attivi f’ Janumet, sitagliptin u metformina idroklorida kull waħda għandha 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
Reproduction is authorised provided the source is acknowledged. ‘ incretin’ hormones in the body.
Reproduction is authorised provided the source is acknowledged. mod differenti ta ’ azzjoni.
These hormones are released after a meal and stimulate the pancreas to produce insulin.
Taħdem billi timblokka t- tkissir ta ’ l- ormoni ta ’ ‘ inkretin ’ fil- ġisem.
How has Janumet been studied?
Kif ġiet studjata Janumet?
Three studies of Januvia, in patients with type 2 diabetes whose blood glucose levels were not adequately controlled on metformin alone, were used to support the use of Janumet in the same indications.
Tliet studji ta ’ Januvia, f’ pazjenti b’ dijabete tat- tip 2 li l- livelli tal- glukożju f’ demmhom ma ġewx ikkontrollati b’ mod xieraq mill- metformina biss, ġew użati sabiex isostnu l- użu ta ’ Janumet fl- istess indikazzjonijiet.
Two ‘ bioequivalence’ studies were also carried out, showing that the active substances in the two strengths of Janumet were absorbed in the body in the same way as when they were taken as separate tablets.
Saru żewġ studji ‘ bijoekwivalenti ’ li juru li s- sustanzi attivi f’ żewġ qawwiet ta ’ Janumet ġew assorbiti fil- ġisem bl- istess mod bħal ma kieku kienu meħuda bħala pilloli separati.
What benefit has Janumet shown during the studies?
Liema benefiċċju wriet Janumet waqt l- istudji li ġew mwettqa?
What is the risk associated with Janumet?
X’ inhu r- riskju assoċjat ma ’ Janumet?
The most common side effect with Janumet (seen in between 1 and 10 patients in 100) is nausea (feeling sick).
L- aktar effett sekondarju komuni ta ’ Janumet (muri f’ bejn pazjent u 10 minn 100) huwa n- nawżja (dardir).
For the full list of all side effects reported with Janumet, see the Package Leaflet.
Għal- lista sħiħa ta 'l- effetti sekondarji rrappurtati ma' Janumet, ara l- Fuljett ta 'Tagħrif.
Janumet should not be used in people who may be hypersensitive (allergic) to sitagliptin, metformin or any of the other ingredients.
Janumet m’ għandux jintuża minn persuni ipersensittivi (allerġiċi) għal sitagliptin, metformina jew għal kull ingredjent ieħor.
It should also not be used in patients with alcohol intoxication (excessive alcohol consumption) or alcoholism, or during breast- feeding.
M’ għandux jintuża f’ pazjenti b’ intossikazzjoni ta ’ l- akoħol (konsum eċċessiv ta ’ l- alkoħol) jew alkoolożmu, jew matul it - treddigħ.
Why has Janumet been approved?
Għaliex ġie approvat Janumet?
The Committee for Medicinal Products for Human Use (CHMP) decided that Janumet’ s benefits are greater than its risks for the treatment of patients with type 2 diabetes mellitus.
Il- Kumitat għall- Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) iddeċieda li Janumet għandu iktar benefiċċji milli riskji fit- trattament tad- dijabete tat- tip 2 mellitus.
The Committee recommended that Janumet be given marketing authorisation.
Il- Kumitat irrakkomanda li Janumet jingħata awtorizzazzjoni għat- tqegħid fis- suq.
2/ 3 The full EPAR for Janumet can be found here.
2/ 3 Informazzjoni oħra dwar Janumet:
This summary was last updated in 05-2008.
L- EPAR sħiħ għal Janumet jista ’ jiġi kkonsultat hawnhekk
EU/ 1/ 08/ 455/ 001 EU/ 1/ 08/ 455/ 002 EU/ 1/ 08/ 455/ 003 EU/ 1/ 08/ 455/ 004 EU/ 1/ 08/ 455/ 005 EU/ 1/ 08/ 455/ 006 EU/ 1/ 08/ 455/ 007 EU/ 1/ 08/ 455/ 008 EU/ 1/ 08/ 455/ 009 EU/ 1/ 08/ 455/ 010 EU/ 1/ 08/ 455/ 011 EU/ 1/ 08/ 455/ 012 EU/ 1/ 08/ 455/ 013 EU/ 1/ 08/ 455/ 014
EMEA/ H/ C/ 000861/ 001 EMEA/ H/ C/ 000861/ 002 EMEA/ H/ C/ 000861/ 003 EMEA/ H/ C/ 000861/ 004 EMEA/ H/ C/ 000861/ 005 EMEA/ H/ C/ 000861/ 006 EMEA/ H/ C/ 000861/ 007 EMEA/ H/ C/ 000861/ 008 EMEA/ H/ C/ 000861/ 009 EMEA/ H/ C/ 000861/ 010 EMEA/ H/ C/ 000861/ 011 EMEA/ H/ C/ 000861/ 012 EMEA/ H/ C/ 000861/ 013 EMEA/ H/ C/ 000861/ 014
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
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
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)
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)
14 tablets 28 tablets 56 tablets 112 tablets 168 tablets 196 tablets 50x1 tablets 14 tablets 28 tablets 56 tablets 112 tablets 168 tablets 196 tablets 50x1 tablets
14 - il pillola 28 pillola 56 pillola 112 - il pillola 168 pillola 196 pillola 50x1 pillola 14 - il pillola 28 pillola 56 pillola 112 - il pillola 168 pillola 196 pillola 50x1 pillola
Janumet 50 mg/ 850 mg film-coated tablets
Janumet 50 mg/ 850 mg pilloli miksijin b’ rita
Janumet is indicated as an adjunct to diet and exercise to improve glycaemic control in patients inadequately controlled on their maximal tolerated dose of metformin alone or those already being treated with the combination of sitagliptin and metformin.
Janumet huwa indikat bħala żieda mad- dieta u ma ’ l- eżerċizzju biex itejjeb il- kontroll gliċemiku għal pazjenti mhux ikkontrollati adegwatament, fuq id- doża massima ttollerata ta ’ metformin waħdu jew għal dawk li diġà qegħdin jiġu kkurati b’ kumbinazzjoni ta ’ sitagliptin u metformin.
Janumet is also indicated in combination with a sulphonylurea (i. e., triple combination therapy) as an adjunct to diet and exercise in patients inadequately controlled on their maximal tolerated dose of metformin and a sulphonylurea.
Janumet huwa indikat ukoll f’ kumbinazzjoni ma ’ sulphonylurea (jiġifieri, terapija ta ’ kumbinazzjoni tripla) bħala żieda mad- dieta u l- eżerċizzju f’ pazjenti mhux ikkontrollati adegwatament fuq id- doża massima ttollerata ta ’ metformin u sulphonylurea.
The dose of antihyperglycaemic therapy with Janumet should be individualised on the basis of the patient’ s current regimen, effectiveness, and tolerability while not exceeding the maximum recommended daily dose of 100 mg sitagliptin.
Id- doża ta ’ terapija kontra l- ipergliċemija b’ Janumet għandha tkun individwalizzata fuq il- bażi tal- kors kurrenti, l- effettività, u t- tolerabbilità tal- pazjent waqt li ma tinqabiżx id- doża massima ta ’ kuljum irrakkomandata ta ’ 100 mg sitagliptin.
For patients inadequately controlled on maximal tolerated dose of metformin monotherapy For patients not adequately controlled on metformin alone, the usual starting dose of Janumet should provide sitagliptin dosed as 50 mg twice daily (100 mg total daily dose) plus the dose of metformin already being taken.
Għal pazjenti mhux ikkontrollati adegwatament fuq id- doża massima ttollerata ta ’ monoterapija b’ metformin Għal pazjenti mhux ikkontrollati adegwatament fuq metformin waħdu, id- doża tal- bidu tas- soltu ta ’ Janumet għandha tkun ta ’ 50 mg sitagliptin darbtejn kuljum (doża totali ta ’ kuljum 100 mg) kif ukoll id- doża ta ’ metformin li tkun diġà bdiet tittieħed.
For patients switching from co-administration of sitagliptin and metformin For patients switching from co-administration of sitagliptin and metformin, Janumet should be initiated at the dose of sitagliptin and metformin already being taken.
Għal pazjenti li sejrin jaqilbu minn għoti konkomitanti ta ’ sitagliptin u metformin Għal pazjenti li sejrin jaqilbu minn għoti konkomitanti ta ’ sitagliptin u metformin, Janumet għandu jinbeda fid- doża ta ’ sitagliptin u metformin li tkun diġà bdiet tittieħed.
For patients inadequately controlled on dual combination therapy with the maximal tolerated dose of metformin and a sulphonylurea The dose of Janumet should provide sitagliptin dosed as 50 mg twice daily (100 mg total daily dose) and a dose of metformin similar to the dose already being taken.
Għal pazjenti mhux ikkontrollati adegwatament fuq terapija ta ’ kombinazzjoni doppja bid- doża massima ttollerata ta ’ metformin u sulphonylurea Id- doża ta ’ Janumet għandha tipprovdi sitagliptin 50 mg darbtejn kuljum (doża totali ta ’ kuljum 100 mg) u doża ta ’ metformin simili għad- doża li diġà qegħda tittieħed.
When Janumet is used in combination with a sulphonylurea, a lower dose of the sulphonylurea may be required to reduce the risk of hypoglycaemia (see section 4.4).
Meta Janumet jintuża f’ kombinazzjoni ma ’ sulphonylurea, tista ’ tkun meħtieġa doża aktar baxxa ta ’ sulphonylurea biex tnaqqas ir- riskju ta ’ ipogliċemija (ara sezzjoni 4. 4).
2 For the different doses on metformin, Janumet is available in strengths of 50 mg sitagliptin and 850 mg metformin hydrochloride or 1000 mg metformin hydrochloride.
2 Għal dożi differenti ta ’ metformin, Janumet jinsab bħala 50 mg sitagliptin u 850 mg metformin hydrochloride jew 1000 mg metformin hydrochloride.
Janumet should be given twice daily with meals to reduce the gastrointestinal undesirable effects associated with metformin.
Janumet għandu jingħata darbtejn kuljum ma ’ l- ikel biex itaffi l- effetti gastrointestinali mhux mixtieqa assoċjati ma ’ metformin.
Patients with renal insufficiency Janumet should not be used in patients with moderate or severe renal impairment (creatinine clearance < 60 ml/ min) (see sections 4.3 and 4.4).
Pazjenti b’ indeboliment tal- kliewi Janumet m’ għandux jintuża f’ pazjenti b’ indeboliment tal- kliewi moderat jew serju (eliminazzjoni ta ’ kreatinin < 60 ml/ min) (ara sezzjonijiet 4. 3 u 4. 4).
Patients with hepatic insufficiency Janumet should not be used in patients with hepatic impairment (see sections 4.3 and 5.2).
Pazjenti b’ indeboliment tal- fwied Janumet m’ għandux jintuża f’ pazjenti b’ indeboliment tal- fwied (ara sezzjonijiet 4. 3 u 5. 2).
Elderly As metformin and sitagliptin are excreted by the kidney, Janumet should be used with caution as age increases.
L- anzjani Minħabba li metformin u sitagliptin huma eliminati mill- kliewi, Janumet għandu jintuża b’ kawtela fuq pazjenti li huma akbar fl- età.
Paediatric population Janumet is not recommended for use in children below 18 years of age due to a lack of data on its safety and efficacy in this population.
Populazzjoni pedjatrika Janumet mhuwiex irrakkomandat fi tfal taħt l- età ta ’ 18- il sena minħabba nuqqas ta ’ dejta fuq is - sigurtà u l- effikaċja tiegħu f’ din il- popolazzjoni.
Janumet is contraindicated in patients with:
Janumet huwa kontraindikat f’ pazjenti b ’:
General Janumet should not be used in patients with type 1 diabetes and must not be used for the treatment of diabetic ketoacidosis.
Ġenerali Janumet m’ għandux jintuża f’ pazjenti b’ dijabete tip 1 jew għall- kura ta ’ ketoaċidożi dijabetika.
Hypoglycaemia Patients receiving Janumet in combination with a sulphonylurea may be at risk for hypoglycaemia.
Ipogliċemija Pazjenti li qegħdin jirċievu Janumet flimkien ma ’ sulphonylurea jistgħu jkunu f’ riskju għal ipogliċemija.
The use of Janumet in combination with insulin has not been adequately studied.
L- użu ta ’ Janumet f’ kumbinazzjoni ma ’ insulina ma ġiex studjat adegwatament.
Onset of these reactions occurred within the first 3 months after initiation of treatment with sitagliptin, with some reports occurring after the first dose.
Dawn ir- reazzjonijiet inkludew anafilassi, anġjoedima, u kundizzjonijiet esfoljattivi tal- ġilda nklużi s- sindromu ta ’ Stevens- Johnson Dawn ir- reazzjonijiet seħħu fi żmien l - ewwel 3 xhur wara l- bidu ta ’ kura b’ sitagliptin, b’ xi rapporti li ġraw ukoll wara l- ewwel doża.
If a hypersensitivity reaction is suspected, discontinue Janumet, assess for other potential causes of the event, and institute alternative treatment for diabetes (see section 4.8).
Jekk tkun issuspettata reazzjoni ta ’ sensittività eċċessiva, waqqaf Janumet, ivvaluta kawżi potenzjali oħrajn għar- reazzjoni, u ibda kura alternattiva għad- dijabete (ara sezzjoni 4. 8).
Surgery As Janumet contains metformin hydrochloride, the treatment should be discontinued 48 hours before elective surgery with general, spinal or epidural anaesthesia.
Kirurġija Minħabba li Janumet fih metformin hydrochloride, il- kura għandha titwaqqaf 48 siegħa qabel kirurġija elettiva b’ loppju ġenerali, anestesija spinali jew epidurali.
Janumet should not usually be resumed earlier than 48 hours afterwards and only after renal function has been re-evaluated and found to be normal.
Janumet ġeneralment m’ għandux jerġa ’ jinbeda aktar kmieni minn 48 siegħa wara u biss wara li l- funzjoni tal- kliewi tkun ġiet evalwata mill - ġdid u nstabet li hija normali.
Therefore, Janumet should be discontinued prior to, or at the time of the test and not reinstituted until 48 hours afterwards, and only after renal function has been re-evaluated and found to be normal (see section 4.5).
Għaldaqstant, Janumet għandu jitwaqqaf qabel, jew fiż- żmien tat- test u ma jerġax jinbeda sa 48 siegħa wara, u biss wara li l- funzjoni tal- kliewi tkun ġiet evalwata mill- ġdid u nstabet li hija normali (ara sezzjoni 4. 5).