qanastek/EMEA-V3 huggingface dataset:
Elderly subjects (65 to 80 years) had approximately 19% higher plasma concentrations of sitagliptin compared to younger subjects.
Suġġetti anzjani (65 sa 80 sena) kellhom konċentrazzjonijiet ta ’ sitagliptin fil- plażma li kienu bejn wieħed u ieħor 19% ogħla meta mqabbla ma ’ suġġetti iżgħar.
Paediatric No studies with Januvia have been performed in paediatric patients.
Pedjatriċi Ma sarux studji b’ Januvia fuq pazjenti pedjatriċi.
Other patient characteristics No dosage adjustment is necessary based on gender, race, or body mass index (BMI).
Karatterisitiċi oħra tal- pazjenti M’ hemmx bżonn bidla fid- doża minħabba sess, razza jew l- indiċi tal- massa tal- ġisem (BMI).
These characteristics had no clinically meaningful effect on the pharmacokinetics of sitagliptin based on a composite analysis of Phase I pharmacokinetic data and on a population pharmacokinetic analysis of Phase I and Phase II data.
Dawn il - karatteristiċi m’ għandhom l- ebda effett kliniku sinifikanti fuq l- effett farmakokinetiku ta ’ sitagliptin skond l- analiżi komposta tat- tagħrif farmakokinetku ta ’ Fażi I u skond l- analiżi farmakokinetika fil - popolazzjoni tat- tagħrif ta ’ Fażi I u Fażi II.
Renal and liver toxicity were observed in rodents at systemic exposure values 58 times the human exposure level, while the no-effect level was found at 19 times the human exposure level.
Fil- waqt li l- livell li fih ma jkunx hemm effett instab li kien ta 19- il darba l- livell ta ’ espożizzjoni fl- umani.
Incisor teeth abnormalities were observed in rats at exposure levels 67 times the clinical exposure level; the no- effect level for this finding was 58-fold based on the 14-week rat study.
Ġew osservati anormalitajiet fis- snien inċiżuri ta ’ firien li ġew esposti għal livelli 67 darba ikbar mill- livell kliniku ta ’ espożizzjoni; għal din is- sejba l- livell ta ’ mingħajr effett kien 58 darba ibbażat fuq studju fuq il- firien ta ’ 14- il ġimgħa.
The relevance of these findings for humans is unknown.
Mhix magħrufa r - relevanza ta ’ dawn is- sejbiet għall- bnedmin.
Transient treatment-related physical signs, some of which suggest neural toxicity, such as open-mouth breathing, salivation, white foamy emesis, ataxia, trembling, decreased activity, and/ or hunched posture were observed in dogs at exposure levels approximately 23 times the clinical exposure level.
Fi klieb li ġew esposti għal bejn wieħed u ieħor 23 darba l- livell kliniku ta ’ espożizzjoni ġew osservati sinjali fiżiċi li jgħaddu marbuta mal- kura, li xi wħud 11 minnhom jissuġgerixxi tossiċità newrali, bħal li jittieħed in- nifs bil- ħalq miftuħ, tibżiq, remettar abjad bir- ragħwa, nuqqas ta ’ ko- ordinament tal- muskoli, trehid, attività mnaqqsa, u/ jew pożizzjoni mħatba.
In addition, very slight to slight skeletal muscle degeneration was also observed histologically at doses resulting in systemic exposure levels of approximately 23 times the human exposure level.
Ukoll, b’ dożi li wasslu għal livelli ta ’ espożizzjoni sistemika 23 darba l- livell ta ’ espożizzjoni uman, ġie osservat istoloġikament deġenerazzjoni fil- muskoli skeletali minn ftit sa ftit ħafna.
A no-effect level for these findings was found at an exposure 6-fold the clinical exposure level.
Il- livell għal dawn is- sejbiet li fih ma kienx hemm effett instab li kien espożizzjoni 6 darbiet il- livell kliniku.
Sitagliptin has not been demonstrated to be genotoxic in preclinical studies.
Fi studji ta ’ qabel l- użu kliniku sitagliptin ma ntweriex li għandu effett tossiku fuq il- ġeni.
Sitagliptin was not carcinogenic in mice.
Sitagliptin ma kienx iwassal għal riskju ta ’ kanċer fil- ġrieden.
In rats, there was an increased incidence of hepatic adenomas and carcinomas at systemic exposure levels 58 times the human exposure level.
Fil- firien, kien hemm inċidenza ikbar ta ’ adenoma u karċinoma fil- fwied b’ espożizzjoni sistemika li kienet 58 darba iktar minn dik fl- umani.
Since hepatotoxicity has been shown to correlate with induction of hepatic neoplasia in rats, this increased incidence of hepatic tumors in rats was likely secondary to chronic hepatic toxicity at this high dose.
Billi l- livell tossiku epatiku ntwera li jikkorelata ma ’ l- induzzjoni ta ’ neoplażja epatika fil- firien, din l- inċidenza ikbar ta ’ tumuri epatiċi fil- firien aktarx li kienet sekondarja għat- tossiċità epatika kronika f’ din id- doża għolja.
Because of the high safety margin (19-fold at this no-effect level), these neoplastic changes are not considered relevant for the situation in humans.
Minħabba l- marġini għoli ta ’ sigurtà (19- il darba f’ dan il- livell ta ’ mingħajr effett), dawn il - bidliet neoplastiċi m’ humiex ikkonsidrati relevanti għall- bnedmin.
No adverse effects upon fertility were observed in male and female rats given sitagliptin prior to and throughout mating.
Ma ġewx osservati effetti avversi fuq il- fertilità tal- firien nisa u rġiel li ngħataw sitagliptin qabel u waqt l- akkoppjament.
In a pre-/ postnatal development study performed in rats sitagliptin showed no adverse effects.
Fi studju dwar l- iżvilupp qabel u wara t- twelid li sar fuq il- firien sitagliptin ma wera l- ebda effett avvers
Reproductive toxicity studies showed a slight treatment-related increased incidence of fetal rib malformations (absent, hypoplastic and wavy ribs) in the offspring of rats at systemic exposure levels more than 29 times the human exposure levels.
Studji ta ’ tossiċità fir- riproduzzjoni wrew li kien hemm inċidenza kemmxejn ikbar marbuta mal- kura ta ’ malformazzjonijiet fil- kustilji fil- ġuf( kustilji neqsin, ipoplastiċi jew immewġin) fil- friegħ tal- firien li kienu esposti għal dożi sistemiċi iktar minn 29 darba l- livell uman.
Maternal toxicity was seen in rabbits at more than 29 times the human exposure levels.
Fil- fniek kien hemm tossiċita materna fl- livelli ta’ espożizzjoni ta ’ aktar minn 29 darba dawk umani.
Because of the high safety margins, these findings do not suggest a relevant risk for human reproduction.
Minħabba l- marġini għolja ta ’ sigurtà, dan it- tagħrif ma jissuġġerix li hemm riskju relevanti għar- riproduzzjoni umana.
Sitagliptin is secreted in considerable amounts into the milk of lactating rats (milk/ plasma ratio:
Sitagliptin huwa sekretat f’ ammonti konsiderevoli fil- ħalib ta ’ firien li qed ireddgħu (proporzjon ħalib/ plażma:
11 croscarmellose sodium (E468) magnesium stearate (E470b) sodium stearyl fumarate
Qalba tal- pillola: microcrystalline cellulose (E460) calcium hydrogen phosphate, anhydrous (E341) croscarmellose sodium (E468) magnesium stearate (E470b) sodium stearyl fumarate
Film coating: polyvinyl alcohol macrogol 3350 talc (E553b) titanium dioxide (E171) red iron oxide (E172) yellow iron oxide (E172)
Rita ta ’ barra: polyvinyl alcohol macrogol 3350 talc (E553b) titanium dioxide (E171) red iron oxide (E172) yellow iron oxide (E172)
6.4 Special precautions for storage
12 6. 4 Prekawzjonijiet speċjali għall- ħażna
This medicinal product does not require any special storage conditions.
Dan il - prodott mediċinali m’ għandux bżonn ta’ kundizzjonijiet speċjali ta’ ħażna.
Packs of 14, 28, 56, 84 or 98 film-coated tablets and 50 x 1 film-coated tablets in perforated unit dose blisters.
Pakketti ta ’ 14, 28, 56, 84 jew 98 pillola miksija b’ rita u 50 x 1 pillola miksija b’ rita f’ folji perforati ta ’ dożi uniċi.
Merck Sharp & Dohme Ltd.
I D- DETENTUR TA’ L- AWTORIZZAZZJONI GHAT- TQEGĦID FIS- SUQ Merck Sharp & Dohme Ltd.
Hertford Road, Hoddesdon Hertfordshire EN11 9BU United Kingdom
Hertford Road, Hoddesdon Hertfordshire EN11 9BU Renju Unit
21 March 2007
21 ta ’ Marzu 2007
Detailed information on this medicinal product is available on the website of the European Medicines Agency (EMEA) web site: http: / /www. emea. europa. eu/.
Tista ’ tinstab informazzjoni dettaljata dwar dan il- prodott mediċinali fis- sit ta ’ l- internet ta ’ l- Aġenzija Ewropea tal- Mediċini (EMEA) sit: http: // www. emea. europa. eu /.
Januvia 50 mg film-coated tablets
Januvia pilloli miksija b’ rita tal- 50 mg
Each tablet contains sitagliptin phosphate monohydrate, equivalent to 50 mg sitagliptin.
Kull pillola fiha sitagliptin phosphate monohydrate, ekwivalenti għal 50 mg ta ’ sitagliptin.
Round, light beige film-coated tablet with “ 112” on one side.
Pillola tonda u beige ċar miksija b’ rita bi “ 112 ” fuq naħa waħda.
14 Patients with renal insufficiency For patients with mild renal insufficiency (creatinine clearance [CrCl] ≥ 50 ml/ min), no dosage adjustment for Januvia is required.
14 Pazjenti b’ insuffiċjenza renali Għal pazjenti b’ insuffiċjenza ħafifa renali (clearance tal- krejatinina [CrCl] ≥50 ml/ min,, m’ hemmx bżonn bidla fid- doża ta ’ Januvia.
Therefore, use of Januvia is not recommended in this patient population (see section 5.2).
Għalhekk, l- użu ta ’ Januvia mhux rakkomandat f' din il- popolazzjoni ta 'pazjenti (ara sezzjoni 5. 2).
Patients with hepatic insufficiency No dosage adjustment is necessary for patients with mild to moderate hepatic insufficiency.
Pazjenti b’ insuffiċjenza epatika M’ hemmx għalfejn bidla fid- doża għal pazjenti li għandhom insuffiċjenza epatika ħafifa jew moderata.
Januvia has not been studied in patients with severe hepatic insufficiency.
Januvia ma ġiex studjat f’ pazjenti b’ insuffiċjenza epatika.
Limited safety data is available in patients ≥ 75 years of age and care should be exercised.
Hemmtagħrif limitat dwar sigurtà f’ pazjenti ta ’ 75 sena jew ikbar u għandhatigi ezercitata attenzjoni
Renal insufficiency As the experience is limited, patients with moderate to severe renal insufficiency should not be treated with Januvia (see section 5.2).
Insuffiċjenza renali Minħabba li l- esperjenza hi limitata, pazjenti b’ insuffiċjenza moderata renali jew severa m’ għandhomx jiġu kkurati b’ Januvia (ara sezzjoni 5. 2).
In clinical studies, sitagliptin did not meaningfully alter the pharmacokinetics of metformin, glyburide, simvastatin, rosiglitazone, warfarin, or oral contraceptives, providing in vivo evidence of a low propensity for causing interactions with substrates of CYP3A4, CYP2C8, CYP2C9, and organic cationic transporter (OCT).
Fi studji kliniċi, sitagliptin ma biddilx b’ mod sinifikanti l- effetti farmakokinetiċi ta ’ metformin, glyburide, simvastatin, rosiglitazone, warfarin, jew kontraċettivi orali, ipprovda evidenza in vivo ghal tendenza baxxa ta ’ interazzjonijiet ma ’ sustrati ta ’ CYP3A4, CYP2C8, CYP2C9, jew trasportatur organiku katjoniku (OCT).
Sitagliptin had a small effect on plasma digoxin concentrations, and may be a mild inhibitor of p- glycoprotein in vivo.
Sitagliptin ftit kellu effett fuq il- konċentrazzjonijiet ta ’ digoxin fil- plażma, u jista ’ jkun inibitur ħafif ta ’ p- glycoprotein in vivo.
Following administration of 0.25 mg digoxin concomitantly with 100 mg of Januvia daily for 10 days, the plasma AUC of digoxin was increased on average by 11%, and the plasma Cmax on average by 18%.
Wara li 0. 25 mg ta ’ digoxin ingħata flimkien ma ’ 100 mg ta’ Januvia MSD kuljum għal 10 ijiem, il- plażma AUC ta ’ digoxin kiber b’ medja ta ’ 11%, u l- plażma Cmax b’ medja ta ’ 18%.
No dosage adjustment of digoxin is recommended.
Mhux rakkomandat li tinbidel id - doża ta ’ digoxin.
However, patients at risk of digoxin toxicity should be monitored for this when sitagliptin and digoxin are administered concomitantly.
Madankollu, pazjenti li għandhom riskju ta ’ tossiċità b’ digoxin għandhom jitħallew taħt sorveljanza għal dan meta sitagliptin u digoxin jingħataw flimkien.
Studies in animals have shown reproductive toxicity at high doses (see section 5.3).
Studji fuq l- annimali urew tossiċità riproduttiva f’ dozi gholjin( ara sezzjoni 5. 3).
Animal studies have shown excretion of sitagliptin in breast milk.
Studji fl- annimali urew li sitagliptin jitneħħa mal- ħalib tas- sider.
Januvia should not be used during breast-feeding.
Januvia m’ għandux jintuża waqt treddigh ta ’ trab ’.
16 4.7 Effects on ability to drive and use machines
16 4. 7 Effetti fuq il- ħila biex issuq u tħaddem magni
However, when driving or operating machines, it should be taken into account that dizziness and somnolence have been reported.
Madankollu, meta ssuq jew tħaddem magni, jrid jigi ikkunsidrat li sturdament u - ngħas gew irrappurtati.
No adverse reactions considered as drug-related were reported in patients treated with sitagliptin occurring in excess (> 0.2% and difference > 1 patient) of that in patients treated with control.
Il- pazjenti li ħadu sitagliptin ma kellhomx iktar reazzjonijiet avversi kunsidrati marbuta mal mediċina (> 0. 2% u differenza ta ’ > 1 pazjent) meta mqabbla ma ’ pazjenti li ħadu kura ta ’ kontroll.
Common
Edema periferali
In clinical trials of Januvia as monotherapy and sitagliptin as part of combination therapy with metformin or pioglitazone, rates of hypoglycaemia reported with sitagliptin were similar to rates in patients taking placebo.
Investigazzjonijie t livell imnaqqas ta ’ Mhux komuni glucose fid- demm 17 * Fi provi kliniċi ta ’ Januvia bħala monoterapija u sitagliptin bħala parti minn terapija ta ’ kombinazzjoni b’ metformin jew pioglitazone, rati ta ’ ipogliċemija rrapportati bi sitagliptin kienu simili għal rati f’ pazjenti li jieħdu plaċebo.
17 1 In this placebo-controlled 24-week study of sitagliptin 100 mg once daily in combination with metformin, the incidence of adverse reactions considered as drug-related in patients treated with sitagliptin/ metformin compared to treatment with placebo/ metformin was 9.3% and 10.1%, respectively.
1 F’ dan l- istudju ta ’ 24 ġimgħa kkontrollat bi plaċebo ta ’ Sitagliptin 100 mg darba kuljum flimkien ma ’ metformin, l- inċidenza ta ’ reazzjonijiet avversi kkunsidrati marbuta mal- mediċina f’ pazjenti ttrattati bi sitagliptin/ metformin meta mqabbla ma ’ trattament bi plaċebo/ metformin kienet ta ’ 9. 3% u 10. 1%, rispettivament.
Across clinical studies, a small increase in white blood cell count (approximately 200 cells/ microl difference in WBC vs. placebo; mean baseline WBC approximately 6600 cells/ microl) was observed due to an increase in neutrophils.
18 F’ numru ta ’ studji kliniċi, kienet osservata żieda żgħira fil- għadd taċ- ċelloli bojod (bejn wieħed u ieħor differenza ta ’ 200 ċellula/ microl f’ WBC meta mqabbel mal- plaċebo: linja medja bażika WBC bejn wieħed u ieħor ta ’ 6600 ċellula/ microl) minħabba żieda fin- newtrofili.
18 No clinically meaningful changes in vital signs or in ECG (including in QTc interval) were observed with Januvia treatment.
F’ kura b’ Januvia ma ġewx osservati bidliet b’ relevanza klinika fis- sinjali vitali jew fl- ECG (inkluż l - intervall QTc).
There is no experience with doses above 800 mg in humans.
M’ hemmx esperjenza b’ dożi ikbar minn 800 mg fil- bniedem.
By enhancing active incretin levels, sitagliptin increases insulin release and decreases glucagon levels in a glucose- dependent manner.
Billi tkattar il- livelli ta ’ incretin 19 attiv, sitgliptin twassal biex tintreħa iktar insulina u jonqsu l- livelli ta ’ glucagon b’ mod li hu marbut mal- glucose.
19 highly selective inhibitor of the enzyme DPP-4 and does not inhibit the closely-related enzymes DPP-8 or DPP-9 at therapeutic concentrations.
Sitagliptin huwa inibitur qawwi u selettiv ħafna ta ’ l- enżima DPP- 4 u ma trażżanx l- enżimi DPP- 8 u DPP- 9 li huma relatati mill- qrib, f’ konċentrazzjonijiet terapewtiċi.
Table 2.
20 Tabella 2:
In a study comparing the efficacy and safety of the addition of Januvia 100 mg once daily or glipizide (a sulphonylurea agent) in patients with inadequate glycaemic control on metformin monotherapy, sitagliptin was similar to glipizide in reducing HbA1c The mean glipizide dose used in the comparator group was 10 mg per day with approximately 40% of patients requiring a glipizide dose of ≤ 5 mg/ day throughout the study.
Id- doża medja ta ’ glipizide użata fil - 21 grupp imqabbel kienet ta ’ 10 mg kuljum b’ madwar 40% tal- pazjenti li kienu jeħtieġu doża ta ’ glipizide ta ’ < 5 mg kuljum għal kemm dam l- istudju.
The absolute bioavailability of sitagliptin is approximately 87%.
Assorbiment Wara l- amministrazzjoni orali ta ’ doża ta ’ 100 mg f’ suġġetti f’ saħħithom, sitagliptin kien assorbit malajr; b' konċentrazzjonijiet massimi fil- plażma (Tmax medju) jintlaħqu minn siegħa sa 4 sigħat wara d- doża, il- plażma medja AUC ta ’ sitagliptin kienet ta ’ 8. 52 μM• hr, Cmax kien 950 nM Il - bijodisponibiltà assoluta ta ’ sitagliptin hija bejn wieħed u ieħor 87%.
Since coadministration of a high-fat meal with Januvia had no effect on the pharmacokinetics, Januvia may be administered with or without food.
Billi t- teħid ta ’ ikla b’ ammont għoli ta ’ xaħam ma ’ Januvia ma kellu l- ebda effett fuq l- effetti farmakokinetiċi, Januvia tista ’ tingħata ma ’ l- ikel jew mingħajru l- ikel.
21 Metabolism Sitagliptin is primarily eliminated unchanged in urine, and metabolism is a minor pathway.
Metaboliżmu Sitagliptin primarjament jitneħħa ma ’ l- urina bla ma jinbidel, u l- metaboliżmu huwa mogħdija minuri.
In vitro, sitagliptin did not inhibit OAT3 (IC50=160 μ M) or p-glycoprotein (up to 250 μ M) mediated transport at therapeutically relevant plasma concentrations.
In vitro, sitagliptin ma kienx jinibixxi transport permezz ta ’ OAT3 22 (IC50=160 μM) jew p- glycoprotein (sa 250 μM) f’ konċentrazzjonijiet fil- plażma terapewtikament relevanti.
Renal insufficiency A single-dose, open-label study was conducted to evaluate the pharmacokinetics of a reduced dose of sitagliptin (50-mg) in patients with varying degrees of chronic renal insufficiency compared to normal healthy control subjects.
Karatteristiċi fil- pazjenti Il- karatteristiċi farmakokinetiċi ta ’ sitagliptin ġeneralment kienu simili f’ suġġetti f’ saħħithom u f’ pazjenti b’ dijabete tat- tip 2.
The study included patients with renal insufficiency classified on the basis of creatinine clearance as mild (50 to < 80 ml/ min), moderate (30 to < 50 ml/ min), and severe (< 30 ml/ min), as well as patients with end-stage renal disease (ESRD) on hemodialysis.
Insuffiċjenza renali Sar studju bil- mediċina magħrufa u b’ doża waħda biex jevalwa l- effetti farmakokinetiċi ta ’ ta ’ doża mnaqqsa ta ’ sitagliptin (50 mg) f’ pazjenti b’ insuffiċjenza renali kronika fi stadji differenti, ikklassifikati skond it- tneħħija tal- kreatinina bħala ħafifa (50 sa < 80 ml/ min), moderata (30 sa < 50 ml/ min), u qawwija (< 30 ml/ min), kif ukoll pazjenti b’ mard renali fl- aħħar stadju tiegħu (ESRD) li kienu qed jieħdu l- emodijalisi.
Patients with mild renal insufficiency did not have a clinically meaningful increase in the plasma concentration of sitagliptin as compared to normal healthy control subjects.
Il- pazjenti b’ insuffiċjenza renali ħafifa ma kellhomx żieda klinikament sinifikanti fil- konċentrazzjoni fil- plażma ta ’ sitagliptin meta mqabbla ma ’ suġġetti normali f’ saħħithom bħala kontroll.
However, because sitagliptin is primarily renally eliminated, severe hepatic insufficiency is not expected to affect the pharmacokinetics of sitagliptin.
Madankollu billi sitagliptin jitneħħa primarjament mill- kliewi, insuffiċjenza epatika qawwija mhix mistennija li taffetw l- effett farmakokinetiku ta ’ sitagliptin.
22 Elderly No dosage adjustment is required based on age.
Anzjani M’ hemmx bżonn aġġustament tad- doża skond l- età.
Transient treatment-related physical signs, some of which suggest neural toxicity, such as open-mouth breathing, salivation, white foamy emesis, ataxia, trembling, decreased activity, and/ or hunched posture were observed in dogs at exposure levels approximately 23 times the clinical exposure level.
Fi klieb li ġew esposti għal bejn wieħed u ieħor 23 darba l- livell kliniku ta ’ espożizzjoni ġew osservati sinjali fiżiċi li jgħaddu marbuta mal- kura, li xi wħud minnhom jissuġgerixxi tossiċità newrali, bħal li jittieħed in- nifs bil- ħalq miftuħ, tibżiq, remettar abjad 23 bir- ragħwa, nuqqas ta ’ ko- ordinament tal- muskoli, trehid, attività mnaqqsa, u/ jew pożizzjoni mħatba.
In rats, there was an increased incidence of hepatic adenomas and carcinomas at systemic exposure levels 58 times the human exposure level.
Fil- firien, kien hemm inċidenza ikbar ta ’ adenoma u karċinoma fil- fwied b’ espożizzjoni sistemika li kienet 58 darba iktar minn dik Fl- umani.
Since hepatotoxicity has been shown to correlate with induction of hepatic neoplasia in rats, this increased incidence of hepatic tumors in rats was likely secondary to chronic hepatic toxicity at this high dose.
Billi l- livell tossiku epatikui ntwera li jikkorelata ma ’ l- induzzjoni ta ’ neoplażja epatika fil- firien, din l- inċidenza ikbar ta ’ tumuri epatiċi fil- firien aktarx li kienet sekondarja għat- tossiċità epatika kronika f’ din id - doża għolja.
Because of the high safety margin (19-fold at this no-effect level), these neoplastic changes are not considered relevant for the situation in humans.
Minħabba l- marġini għoli ta ’ sigurtà (19- il darba f’ dan il- livell ta ’ mingħajr effett), dawn il- bidliet neoplastiċi m’ humiex ikkonsidrati relevanti għall- bnedmin.
In a pre-/ postnatal development study performed in rats sitagliptin showed no adverse effects.
Fi studju dwar l- iżvilupp qabel u wara t- twelid li sar fuq il- firien sitagliptin ma wera l- ebda effett avvers.
23 croscarmellose sodium (E468) magnesium stearate (E470b) sodium stearyl fumarate
Qalba tal- pillola: microcrystalline cellulose (E460) calcium hydrogen phosphate, anhydrous (E341) croscarmellose sodium (E468) magnesium stearate (E470b) sodium stearyl fumarate
6.4 Special precautions for storage
24 6. 4 Prekawzjonijiet speċjali għall- ħażna
This medicinal product does not require any special storage conditions.
Dan il- prodott mediċinali m’ għandux bżonn ta’ kundizzjonijiet speċjali ta’ ħażna.
6.6 Special precautions for disposal
6. 6 P rekawzjonijiet speċjali li għandhom jittieħdu meta jintrema.
Januvia 100 mg film-coated tablets
Januvia pilloli miksija b’ rita tal- 100 mg
Each tablet contains sitagliptin phosphate monohydrate, equivalent to 100 mg sitagliptin.
Kull pillola fiha sitagliptin phosphate monohydrate, ekwivalenti għal 100 mg ta ’ sitagliptin.
Round, beige film-coated tablet with “ 277” on one side.
Pillola tonda u beige miksija b’ rita bi “ 227 ” fuq naħa waħda.
26 Patients with renal insufficiency For patients with mild renal insufficiency (creatinine clearance [CrCl] ≥ 50 ml/ min), no dosage adjustment for Januvia is required.
26 Pazjenti b’ insuffiċjenza renali Għal pazjenti b’ insuffiċjenza ħafifa renali (clearance tal- krejatinina [CrCl] ≥50 ml/ min,, m’ hemmx bżonn bidla fid- doża ta ’ Januvia.
Januvia has not been studied in patients with severe hepatic insufficiency.
Januvia ma ġiex studjat f’ pazjenti b’ insuffiċjenza epatika qawwija.
Limited safety data is available in patients ≥ 75 years of age and care should be exercised.
Hemmtagħrif limitat dwar sigurtà f’ pazjenti ta ’ 75 sena jew ikbar u għandha tigi ezercitata attenzjoni.
Effects of sitagliptin on other medicinal products In vitro data suggest that sitagliptin does not inhibit nor induce CYP450 isoenzymes.
Tagħrif in vitro jagħti x’ jifhem li sitagliptin la jinibixxi u l- anqas jinduċi l- isoenżimi CYP450.
In clinical studies, sitagliptin did not meaningfully alter the pharmacokinetics of metformin, glyburide, simvastatin, rosiglitazone, warfarin, or oral contraceptives, providing in vivo evidence of a low propensity for causing interactions with substrates of CYP3A4, CYP2C8, CYP2C9, and organic cationic transporter (OCT).
Fi studji kliniċi, sitagliptin ma biddilx b’ mod sinifikanti l- effetti farmakokinetiċi ta ’ metformin, glyburide, simvastatin, rosiglitazone, warfarin, jew kontraċettivi orali, u dan ipprovda evidenza in vivo ghal tendenza baxxa ta ’ interazzjonijiet ma ’ sustrati ta ’ CYP3A4, CYP2C8, CYP2C9, jew trasportatur organiku katjoniku (OCT).
Sitagliptin had a small effect on plasma digoxin concentrations.
Sitagliptin kellu effett żgħir fuq konċentrazzjonijiet ta ’ digoxin fil- plażma..
28 4.7 Effects on ability to drive and use machines
28 4. 7 Effetti fuq il- ħila biex issuq u tħaddem magni
In clinical trials of Januvia as monotherapy and sitagliptin as part of combination therapy with metformin or pioglitazone, rates of hypoglycaemia reported with sitagliptin were similar to rates in patients taking placebo.
29 * Fi provi kliniċi ta ’ Januvia bħala monoterapija u sitagliptin bħala parti minn terapija ta ’ kombinazzjoni b’ metformin jew pioglitazone, rati ta ’ ipogliċemija rrapportati bi sitagliptin kienu simili għal rati f’ pazjenti li jieħdu plaċebo.
29 1 In this placebo-controlled 24-week study of sitagliptin 100 mg once daily in combination with metformin, the incidence of adverse reactions considered as drug-related in patients treated with sitagliptin/ metformin compared to treatment with placebo/ metformin was 9.3% and 10.1%, respectively.
1 F’ dan l- istudju ta ’ 24 ġimgħa kkontrollat bi plaċebo ta ’ Sitagliptin 100 mg darba kuljum flimkien ma ’ metformin, l- inċidenza ta ’ reazzjonijiet avversi kkunsidrati marbuta mal- mediċina f’ pazjenti ttrattati bi sitagliptin/ metformin meta mqabbla ma ’ trattament bi plaċebo/ metformin kienet ta ’ 9. 3% u 10. 1%, rispettivament.
In a 24-week study of initial combination therapy with sitagliptin and metformin administered twice daily (sitagliptin/ metformin 50 mg/ 500 mg or 50 mg/ 1000 mg), the overall incidence of adverse reactions considered as drug-related in patients treated with the combination of sitagliptin and metformin compared to patients treated with placebo was 14.0% and 9.7%, respectively.
30 Fi studju ta ’ 24 ġimgħa ta ’ terapija ta ’ kombinazzjoni inizjali bi sitagliptin u metformin mogħtija darbtejn kuljum (sitagliptin/ metformin 50 mg/ 500 mg jew 50 mg/ 1000 mg), l- inċidenza totali ta ’ reazzjonijiet avversi meqjusin relatati mal- mediċina f’ pazjenti ttratti b’ kombinazzjoni ta ’ sitagliptin u metformin meta mqabbla ma ’ pazjenti ttrattati bi plaċebo kienet ta ’ 14. 0% u 9. 7%, rispettivament.
Across clinical studies, a small increase in white blood cell count (approximately 200 cells/ microl difference in WBC vs. placebo; mean baseline WBC approximately 6600 cells/ microl) was observed due to an increase in neutrophils.
F’ numru ta ’ studji kliniċi, kienet osservata żieda żgħira fil- għadd taċ- ċelloli bojod (bejn wieħed u ieħor differenza ta ’ 200 ċellula/ microl f’ WBC meta mqabbel mal- plaċebo: linja medja bażika WBC bejn wieħed u ieħor ta ’ 6600 ċellula/ microl) minħabba żieda fin- newtrofili.
30 No clinically meaningful changes in vital signs or in ECG (including in QTc interval) were observed with Januvia treatment.
F’ kura b ’ Januvia ma ġewx osservati bidliet b’ relevanza klinika fis- sinjali vitali jew fl- ECG (inkluż l - intervall QTc).
Decreased glucagon concentrations, along with higher insulin levels, lead to reduced hepatic glucose production, resulting in a decrease in blood glucose levels.
Konċentrazzjonijiet inqas ta ’ glucagons, flimkien ma ’ livelli 31 ogħla ta ’ insulina, iwasslu għal tnaqqis fil- produzzjoni ta ’ glucose mill- fwied, li jwassal għal tnaqqis fil- livell ta ’ glucose fid- demm.
By enhancing active incretin levels, sitagliptin increases insulin release and decreases glucagon levels in a glucose- dependent manner.
Billi tkattar il- livelli ta ’ incretin attiv, sitgliptin twassal biex tintreħa iktar insulina u jonqsu l- livelli ta ’ glucagon b’ mod li hu marbut mal- glucose.
31 highly selective inhibitor of the enzyme DPP-4 and does not inhibit the closely-related enzymes DPP-8 or DPP-9 at therapeutic concentrations.
Sitagliptin huwa inibitur qawwi u selettiv ħafna ta ’ l- enżima DPP- 4 u ma trażżanx l- enżimi DPP- 8 u DPP- 9 li huma relatati mill- qrib, f’ konċentrazzjonijiet terapewtiċi.
In a 24-week placebo-controlled factorial study of initial therapy, sitagliptin 50 mg twice daily in combination with metformin (500 mg or 1000 mg twice daily) provided significant improvements in glycaemic parameters compared with either monotherapy.
Fi studju fattorjali ta ’ 24 ġimgħa kkontrollat bi plaċebo ta ’ terapija inizjali, sitagliptin 50 mg darbtejn kuljum f’ kombinazzjoni ma ’ metformin (500 mg jew 1000 mg darbtejn kuljum) irriżulta f’ titjib 32 sinifikanti fil- parametri gliċemiċi meta mqabbel ma ’ monoterapija waħda jew l- oħra.
Table 2.
33 Tabella 2:
(95% CI)
(95% CI) - 0. 6 ‡
Sitagliptin 100 mg once daily§ (N= 193) Sitagliptin 100 mg once daily (N= 229) Combination Therapy Studies
darba kuljum§ (N= 193) Sitagliptin 100 mg
8.0 8.0
8. 0
-0.5 -0.6
- 0. 5
-0.6‡ (-0.8, -0.4) -0.8‡ (-1.0, -0.6)
(- 0. 8, - 0. 4) - 0. 8 ‡
Placebo-corrected mean
darba kuljum (N= 229)
Mean
8. 0
Study
- 0. 6
The mean glipizide dose used in the comparator group was 10 mg per day with approximately 40% of patients requiring a glipizide dose of ≤ 5 mg/ day throughout the study.
Id- doża medja ta ’ glipizide użata fil - 34 grupp imqabbel kienet ta ’ 10 mg kuljum b’ madwar 40% tal- pazjenti li kienu jeħtieġu doża ta ’ glipizide ta ’ < 5 mg kuljum għal kemm dam l- istudju.
33 Metabolism Sitagliptin is primarily eliminated unchanged in urine, and metabolism is a minor pathway.
Metaboliżmu Sitagliptin primarjament jitneħħa ma ’ l- urina bla ma jinbidel, u l- metaboliżmu huwa mogħdija minuri.
In vitro data showed that sitagliptin is not an inhibitor of CYP isozymes CYP3A4, 2C8, 2C9, 2D6, 1A2, 2C19 or 2B6, and is not an inducer of CYP3A4 and CYP1A2.
Tagħrif in vitro wera li sitagliptin mhux inibitur ta ’ CYP isozymes CYP3A4, 2C8, 2C9, 2D6, 1°2, 2C19 jew 2B6, and ma huwiex stimulatur ta’ CYP3A4 u CYP1A2.
In vitro, sitagliptin did not inhibit OAT3 (IC50=160 μ M) or p-glycoprotein (up to 250 μ M) mediated transport at therapeutically relevant plasma concentrations.
In vitro, sitagliptin ma kienx jinibixxi transport permezz ta ’ OAT3 35 (IC50=160 μM) jew p- glycoprotein (sa 250 μM) f’ konċentrazzjonijiet fil- plażma terapewtikament relevanti.
The study included patients with renal insufficiency classified on the basis of creatinine clearance as mild (50 to < 80 ml/ min), moderate (30 to < 50 ml/ min), and severe (< 30 ml/ min), as well as patients with end-stage renal disease (ESRD) on hemodialysis.
Insuffiċjenza renali Sar studju bil- mediċina magħrufa u b’ doża waħda biex jevalwa l- effetti farmakokinetiċi ta ’ doża mnaqqsa ta ’ sitagliptin (50 mg) f’ pazjenti b’ insuffiċjenza renali kronika fi stadji differenti, ikklassifikati skond it- tneħħija tal- kreatinina bħala ħafifa (50 sa < 80 ml/ min), moderata (30 sa < 50 ml/ min), u qawwija (< 30 ml/ min), kif ukoll pazjenti b’ mard renali fl- aħħar stadju tiegħu (ESRD) li kienu qed jieħdu l- emodijalisi.
Sitagliptin was modestly removed by hemodialysis (13.5% over a 3- to 4-hour hemodialysis session starting 4 hours postdose).
Sitagliptin tneħħa xi ftit bl- emodijalisi (13. 5% wara sessjoni ta ’ emodijalisi ta ’ bejn 3 u 4 sigħat li idet 4 sigħat wara d- dożaġġ).
34 Elderly No dosage adjustment is required based on age.
Anzjani M’ hemmx bżonn aġġustament tad- doża skond l- età.
Other patient characteristics No dosage adjustment is necessary based on gender, race, or body mass index (BMI).
Karatterisitiċi oħra tal- pazjenti M’ hemmx bżonn bidla fid- doża minħabbasess, razza jew l- indiċi tal- massa tal- ġisem (BMI).
Transient treatment-related physical signs, some of which suggest neural toxicity, such as open-mouth breathing, salivation, white foamy emesis, ataxia, trembling, decreased activity, and/ or hunched posture were observed in dogs at exposure levels approximately 23 times the clinical exposure level.
Fi klieb li ġew esposti għal bejn wieħed u ieħor 23 darba l- livell kliniku ta ’ espożizzjoni ġew osservati sinjali fiżiċi li jgħaddu marbuta mal- kura, li xi wħud 36 minnhom jissuġgerixxi tossiċità newrali, bħal li jittieħed in- nifs bil- ħalq miftuħ, tibżiq, remettar abjad bir- ragħwa, nuqqas ta ’ ko- ordinament tal- muskoli, trehid, attività mnaqqsa, u/ jew pożizzjoni mħatba.
Because of the high safety margins, these findings do not suggest a relevant risk for human reproduction.
Fil- fniek kien hemm tossiċita materna fl- livelli ta’ espożizzjoni ta ’ aktar minn 29 darba dawk umani. Minħabba l- marġini għolja ta ’ sigurtà, dan it- tagħrif ma jissuġġerix li hemm riskju relevanti għar- riproduzzjoni umana.
35 croscarmellose sodium (E468) magnesium stearate (E470b) sodium stearyl fumarate
Qalba tal- pillola: microcrystalline cellulose (E460) calcium hydrogen phosphate, anhydrous (E341) croscarmellose sodium (E468) magnesium stearate (E470b) sodium stearyl fumarate
6.6 Special precautions for disposal
6. 6 Prekawzjonijiet speċjali li għandhom jittieħdu meta jintrema. imi
MARKETING AUTHORISATION HOLDER
ID- DETENTUR TA’ L AWTORIZZAZZJONI GHAT- TQEGĦID FIS- SUQ
37 ANNEX II
38 ANNESS II
Via Emilia 21 IT-27100 Pavia Italy
Via Emilia 21 IT- 27100 Pavia L- Italja
The MAH must ensure that the system of pharmacovigilance, as described in version 2 presented in Module 1.8.1. of the Marketing Authorisation Application and any subsequent updates, is in place and functioning before and whilst the product is on the market.
Id- Detentur ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- Suq għandu jiżgura li s- sistema ta ’ farmakoviġilanza, kif deskritta fil- verżjoni 2 ippreżentata fil- Modulu 1. 8. 1. ta ’ l- Applikazzjoni ta ’ l - Awtorizzazzjoni għat- Tqegħid fis- Suq u kwalunkwe aġġustament sussegwenti, ikun fis- seħħ qabel u waqt li l- prodott ikun fis- suq.
The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in version 1.1 of the Risk Management Plan (RMP) presented in Module 1.8.2. of the Marketing Authorisation Application and any subsequent updates of the RMP agreed by the CHMP.
Id- Detentur ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- Suq jimpenja ruħu li jwettaq l- istudji u l- attivitajiet ta ’ farmakoviġilanza addizzjonali mogħtija fid- dettall fil- Pjan ta ’ Farmakoviġilanza, kif sar qbil fuqhom fil- verżjoni 1. 1 tal- Pjan tal- Ġestjoni tar- Riskji (RMP) ippreżentat fil- Modulu 1. 8. 2. ta ’ l - Applikazzjoni għall- Awtorizzazzjoni għat- Tqegħid fis- Suq u kull aġġornament sussegwenti tal- RMP li jkun sar qbil fuqu mill- CHMP.
As per the CHMP Guideline on Risk Management Systems for medicinal products for human use, the updated RMP should be submitted at the same time as the next Periodic Safety Update Report (PSUR).
B’ mod konformi mal- Linja gwida tal- CHMP dwar Sistemi ta ’ Ġestjoni tar- Riskji għal prodotti mediċinali għall- użu mill- bniedem, l- RMP aġġornat għandu jiġi ippreżentat fl- istess żmien tar- Rapport Perjodiku ta ’ Aġġornament tas- Sigurtà (PSUR) li jmiss.
In addition, an updated RMP should be submitted
Barra minn hekk, għandu jiġi ppreżentat RMP aġġornat.
· When new information is received that may impact on the current Safety Specification,
Meta tiġi rċevuta informazzjoni ġdida li jista ’ jkollha impatt fuq l- Ispeċifikazzjoni tas- Sigurtà attwali, fuq il- Pjan tal- Farmakoviġilanza jew fuq l- attivitajiet ta ’ minimizzazzjoni tar- riskji.
· Within 60 days of an important (pharmacovigilance or risk minimisation) milestone being reached
Fi żmien 60 jum minn meta tintlaħaq mira importanti (farmakoviġilanza jew minimizzazzjoni tar - riskji).
· At the request of the EMEA
Fuq talba ta ’ l- EMEA
40 A.
40 ANNESS III
41 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
TIKKETTA
Outer carton for Januvia 25 mg film-coated tablets
Kartuna ta ’ barra għall- pilloli Januvia ta ’ 25 mg mikisja b’ rita
Januvia 25 mg film-coated tablets Sitagliptin
Januvia 25 mg pilloli miksija b’ rita Sitagliptin
Each tablet contains sitagliptin phosphate monohydrate equivalent to 25 mg of sitagliptin.
Kull pillola fiha sitagliptin phosphate monohydrate ekwivalenti għal 25 mg ta ’ sitagliptin.
14 film-coated tablets 28 film-coated tablets 56 film-coated tablets 84 film-coated tablets 98 film-coated tablets 50 x 1 film-coated tablets
14- il pillola miksija b’ rita 28 pillola miksija b’ rita 56 pillola miksija b’ rita 84 pillola miksija b’ rita 98 pillola miksija b’ rita 50 x 1 pillola miksija b’ rita
Read the package leaflet before use.
Aqra l- fuljett tal- pakkett qabel l- użu.
EXP
JIS {XX/ SSSS}
EU/ 1/ 07/ 383/ 001 14 film-coated tablets EU/ 1/ 07/ 383/ 002 28 film-coated tablets EU/ 1/ 07/ 383/ 003 56 film-coated tablets EU/ 1/ 07/ 383/ 004 84 film-coated tablets EU/ 1/ 07/ 383/ 005 98 film-coated tablets EU/ 1/ 07/ 383/ 006 50 x 1 film-coated tablets
EU/ 0/ 00/ 000/ 000 14- il pillola miksija b’ rita EU/ 0/ 00/ 000/ 000 28 pillola miksija b’ rita EU/ 0/ 00/ 000/ 000 56 pillola miksija b’ rita EU/ 0/ 00/ 000/ 000 84 pillola miksija b’ rita EU/ 0/ 00/ 000/ 000 98 pillola miksija b’ rita EU/ 0/ 00/ 000/ 000 50 x 1 pillola miksija b’ rita
INFORMATION IN BRAILLE
INFORMATION FIL- BRAILLE
43 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
44 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ L- ISTRIXXI JEW FUQ IL- FOLJI
Blister for Januvia 25 mg film-coated tablets
Folja għall- pilloli ta’ 25 mg Januvia miksija b’ rita
Januvia 25 mg tablets Sitagliptin
Pilloli ta ’ Januvia 25 mg Sitagliptin
Outer carton for Januvia 50 mg film-coated tablets
Kartuna ta ’ barra għall- pilloli Januvia ta ’ 50 mg mikisja b’ rita
Januvia 50 mg film-coated tablets Sitagliptin
Januvia 50 mg pilloli miksija b’ rita Sitagliptin
Each tablet contains sitagliptin phosphate monohydrate equivalent to 50 mg of sitagliptin.
Kull pillola fiha sitagliptin phosphate monohydrate ekwivalenti għal 50 mg ta ’ sitagliptin.
EU/ 1/ 07/ 383/ 007 14 film-coated tablets EU/ 1/ 07/ 383/ 008 28 film-coated tablets EU/ 1/ 07/ 383/ 009 56 film-coated tablets EU/ 1/ 07/ 383/ 010 84 film-coated tablets EU/ 1/ 07/ 383/ 011 98 film-coated tablets EU/ 1/ 07/ 383/ 012 50 x 1 film-coated tablets
EU/ 0/ 00/ 000/ 000 14- il pillola miksija b’ rita EU/ 0/ 00/ 000/ 000 28 pillola miksija b’ rita EU/ 0/ 00/ 000/ 000 56 pillola miksija b’ rita EU/ 0/ 00/ 000/ 000 84 pillola miksija b’ rita EU/ 0/ 00/ 000/ 000 98 pillola miksija b’ rita EU/ 0/ 00/ 000/ 000 50 x 1 pillola miksija b’ rita
Blister for Januvia 50 mg film-coated tablets
Folja għall- pilloli ta ’ 50 mg Januvia miksija b’ rita
Januvia 50 mg tablets Sitagliptin
Pilloli ta ’ Januvia 50 mg Sitagliptin
NAME OF THE MARKETING AUTHORISATION HOLDER
ISEM TA TAD- DETENTUR TA ’ L- AWTORIZZAZZJONI GĦAT- TQEGĦID FIS- SUQ
Outer carton for Januvia 100 mg film-coated tablets
Kartuna ta ’ barra għall- pilloli Januvia ta ’ 100 mg mikisja b’ rita
Januvia 100 mg film-coated tablets Sitagliptin
Januvia 100 mg pilloli miksija b’ rita Sitagliptin
Each tablet contains sitagliptin phosphate monohydrate equivalent to 100 mg of sitagliptin.
Kull pillola fiha sitagliptin phosphate monohydrate ekwivalenti għal 100 mg ta ’ sitagliptin.
EU/ 1/ 07/ 383/ 013 14 film-coated tablets EU/ 1/ 07/ 383/ 014 28 film-coated tablets EU/ 1/ 07/ 383/ 015 56 film-coated tablets EU/ 1/ 07/ 383/ 016 84 film-coated tablets EU/ 1/ 07/ 383/ 017 98 film-coated tablets EU/ 1/ 07/ 383/ 018 50 x 1 film-coated tablets
EU/ 0/ 00/ 000/ 000 14- il pillola miksija b’ rita EU/ 0/ 00/ 000/ 000 28 pillola miksija b’ rita EU/ 0/ 00/ 000/ 000 56 pillola miksija b’ rita EU/ 0/ 00/ 000/ 000 84 pillola miksija b’ rita EU/ 0/ 00/ 000/ 000 98 pillola miksija b’ rita EU/ 0/ 00/ 000/ 000 50 x 1 pillola miksija b’ rita
49 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
50 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ L- ISTRIXXI JEW FUQ IL- FOLJI
Blister for Januvia 100 mg film-coated tablets
Folja għall- pilloli ta ’ 100 mg Januvia miksija b’ rita
Januvia 100 mg tablets Sitagliptin
Pilloli ta ’ Januvia 100 mg Sitagliptin
- If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet,
- Jekk xi wieħed mill- effetti sekondarji jiggrava, jew jekk tinnota effetti sekondarji li mhux
please tell your doctor or pharmacist.
imsemmijinf’ dan il- fuljett, jekk jogħġbok għid lit- tabib jew spiżjar tiegħek.
What Januvia is and what it is used for 2.
X’ inhu Januvia u għalxiex jintuża 2.
Before you take Januvia 3.
Qabel ma tieħu Januvia 3.
How to take Januvia 4.
Kif għandek tieħu Januvia 4.
How to store Januvia 6.
Kif taħżen Januvia 6.
WHAT JANUVIA IS AND WHAT IT IS USED FOR
X’ INHI JANUVIA U GĦALXIEX TINTUŻA
Januvia is a member of a class of medicines you take by mouth called DPP-4 inhibitors (dipeptidyl peptidase-4 inhibitors) that lowers blood sugar levels in patients with type 2 diabetes mellitus.
Januvia hija membru tal- klassi ta ’ mediċini li tieħu minn ħalqek u li jissejħu inibituri DPP- 4 (inibituri (dipeptidyl peptidase- 4) li tbaxxi l- livell taz- zokkor fid- demm f’ pazjenti li għandhom id- dijabete mellitus tat- tip 2.
Type 2 diabetes is also called non-insulin-dependent diabetes mellitus, or NIDDM.
Id- dijabete tat- tip 2 tissejjaħ ukoll dijabete mellitus li ma tiddependix fuq l- insulina, jew NIDDM.
Januvia helps to improve the levels of insulin after a meal and decreases the amount of sugar made by the body.
Januvia tgħin itejjeb il- livell ta ’ insulina wara ikla u tnaqqas l- ammont ta ’ zokkor li jipproduċi l- ġisem.
It is unlikely to cause low blood sugar because it does not work when your blood sugar is low.
Ftit hemm ċans li tikkawża livell baxx ta ’ zokkor fid- demm billi ma taħdimx meta l- livell taz- zokkor huwa baxx.
However, when Januvia is used in combination with a sulphonylurea medicine, low blood sugar (hypoglycaemia) can occur.
Iżda, meta Januvia jingħata flimkien ma ’ mediċini ta ’ sulphonylurea, jista ’ jkun hemm livell baxx ta ’ zokkor fid- demm (ipogliċemija).
Your doctor has prescribed Januvia to help lower your blood sugar, which is too high because of your type 2 diabetes.
It- tabib tiegħek ordnalek Januvia biex jgħinek tnaqqas il- livell tal- żokkor fid- demm, li hu għoli wisq minħabba id- dijabete ta ’ tip 2 li għandek.
Januvia is used in combination with certain other medicines that lower blood sugar, which you will already be taking for your diabetes together with a food and exercise plan.
Januvia jintuża ma ’ ċerti mediċini oħra li jnaqqsu l- livell taz- zokor fid- demm, li tkun diġà qed tieħu minħabba d- dijabete flimkien ma ’ ma ’ pjan ta ’ ikel u ta ’ eżerċizzju fiżiku.
Your doctor is now prescribing Januvia as an additional medicine to help control your blood sugar.
It- tabib tiegħek issa qed jordnalek Januvia bħala mediċina oħra biex tgħinek tikkontrolla l- livelli taz- zokkor fid- demm.
What is type 2 diabetes?
X’ inhi d- dijabete tat- tip 2?
Type 2 diabetes is a condition in which your body does not make enough insulin, and the insulin that your body produces does not work as well as it should.
Meta għandek id- dijabete tat- tip 2 ġismek ma jipproduċix biżżejjed insulina, u l- insulina li jipproduċi ġismek ma taħdimx kif suppost.
Your body can also make too much sugar.
Ġismek jista ’ wkoll jipproduċi wisq zokkor.
When this happens, sugar (glucose) builds up in the blood.
Meta jiġri dan, iz - żokkor (glucose) jibda jinġema ’ fid- demm.
This can lead to serious medical problems like heart disease, kidney disease, blindness, and amputation.
Dan jista ’ jwassal għal problemi mediċi serji bħal mard tal - qalb, mard tal- kliewi, għama u amputazzjoni.
BEFORE YOU TAKE JANUVIA
QABEL MA TIEĦU JANUVIA
Do not take Januvia
Tiħux Januvia:
- if you are allergic (hypersensitive) to sitagliptin or any of the other ingredients of Januvia.
- jekk inti allerġiku/ a (tbati minn sensittivita eċċessiva) għal sitagliptin jew sustanzi oħra ta ’
Take special care with Januvia Tell your doctor if you have or have had:
Lit- tabib tiegħek għidlu jekk għandek jew kellek:
- type 1 diabetes
- id- dijabete ta ’ tip 1
- diabetic ketoacidosis (a complication of diabetes with high blood sugar, rapid weight loss,
- ketoaċidosi dijabetika (komplikazzjoni tad- dijabete b' livell għoli ta ’ zokkor fid- demm, tnaqqis
nausea or vomiting)
f’ daqqa fil- piż, nawżja jew remettar)
- any kidney problems, or any past or present medical problems.
- xi problemi bil- kliewi, jew problemi mediċi fil- pass jew fil- preżent.
If you have kidney problems,
Jekk għandek problemi tal -
52
kliewi, Januvia jista ’ ma jkunx il- mediċina adattata għalik.
- an allergic reaction to Januvia.
- reazzjoni allerġika għal Januvia.
If you are taking a sulphonylurea with Januvia you may experience low blood sugar.
Jekk qed tieħu sulphonylurea ma ’ Januvia tista ’ tesperjenza livell baxx ta ’ zokkor fid- demm.
Your doctor may reduce the dose of your sulphonylurea medication.
It- tabib tiegħek jista ’ jnaqqas id- doża tal- mediċina ta ’ sulphonylurea tiegħek.
Taking other medicines Januvia may be taken with most medicines.
Meta tieħu mediċina oħra Januvia tista ’ tittieħed mal- biċċa l- kbira tal- mediċini.
Tell your doctor or pharmacist about all the medicines you take or have recently taken.
Għidlu lit- tabib jew lill- ispiżjar tiegħek dwar kull mediċina li qed tieħu jew li ħadt dan l- aħħar.
This includes prescription and non-prescription medicines, and herbal supplements.
Dan jinkludi mediċina bi preskrizzjoni jew mingħajrha, u supplementi tal- ħxejjex.
Taking Januvia with food and drink You can take Januvia with or without food and drink.
Tista ’ tieħu Januvia ma ’ l- ikel u x- xorb jew waħedha.
Pregnancy and breast-feeding Women who are pregnant or plan to become pregnant should consult their doctor before taking Januvia.
Tqala u treddigħ Nisa tqal jew li qed jippjanaw tqala għandhom jikkonsultaw mat- tabib tagħhom qabel ma jieħdu Januvia.
You should not use Januvia during pregnancy.
M’ għandekx tieħuJanuvia waqt it- tqala.
It is not known if Januvia passes into breast milk.
Mhux magħruf jekk Januvia jgħaddix mal- ħalib tas- sider.
You should not use Januvia if you are breast-feeding or plan to breast-feed.
M’ għandekx tuża Januvia jekk qed tredda ’ jew beħsiebek tredda ’.
Driving and using machines Januvia is not expected to interfere with your ability to drive or to use machines.
Januvia mhux mistenni li jaffettwa l- ħila tiegħek li ssuq jew biex tħaddem il- magni.
However, when driving or operating machinery, it should be taken into account that dizziness and drowsiness have been reported.
Madankollu, meta ssuq jew tkun tħaddem il- magni, għandek tikkunsidra l- fatt li sturdament u ngħas ġew irrappurtati.
HOW TO TAKE JANUVIA
KIF GĦANDEK TIEĦU JANUVIA
Always take Januvia exactly as your doctor has told you.
Dejjem għandek tieħu Januvia skond il- parir tat- tabib.
The usual dose is: − one 100 mg film-coated tablet − once a day − by mouth
- pillola waħda miksija b’ rita tal- 100 mg
Your doctor will prescribe Januvia along with certain other medicines that lower blood sugar.
It- tabib tiegħek se jagħtik Januvia flimkien ma ’ ċerti mediċini oħra li jbaxxu l- livelli taz- zokkor fid - demm.
Continue to take Januvia as long as your doctor prescribes it so you can continue to help control your blood sugar.
Kompi ħu Januvia sakemm jgħidlek it- tabib biex tkompli tikkontrolla l- livelli taz- zokkor fid- demm.
Diet and exercise can help your body use its blood sugar better.
Id- dieta u l- eżerċizzju fiżiku jistgħu jgħinu biex ġismek juża z- zokkor fid- demm aħjar.
It is important to stay on the diet, exercise and weight loss program recommended by your doctor while taking Januvia.
Waqt li qed tieħu Januvia importanti li tibqa ’ fuq il- programm ta ’ dieta, eżerċizzju fiżiku u tnaqqis tal- piż li jirrikmandalek it- tabib.
If you take more Januvia than you should If you take more than the prescribed dosage of Januvia, contact your doctor immediately.
Jekk tieħu Januvia aktar milli suppost Jekk tieħu iktar Januvia milli suppost, ikkuntattja mal- ewwel lit- tabib tiegħek.
If you forget to take Januvia If you miss a dose, take it as soon as you remember.
Jekk tinsa tieħu Januvia Jekk taqbeż doża, ħudha malli tiftakar.
If you do not remember until it is time for your next dose, skip the missed dose and go back to your regular schedule.
Jekk ma tiftakarx sakemm isir il- ħin għad- doża li jmiss, aqbeż id- doża li nsejt tieħu u erġa ’ ibda b’ mod normali.
Do not take a double dose of Januvia.
M’ għandekx tieħu doża doppja ta ’ Januvia.
Like all medicines, Januvia may cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, Januvia jista ’ jkollha effetti sekondarji, għalkemm dawn ma jidhrux fuq kulħadd.
53 Very common side effects (more than 1 per 10 patients) Common side effects (less than 1 per 10 but more than 1 per 100 patients) Uncommon side effects (less than 1 per 100 but more than 1 per 1000 patients)
Effetti sekondarji komuni ħafna (iktar minn 1 kull 10 pazjenti) Effetti sekondarji komuni (inqas minn 1 kull 10 imma iktar minn 1 kull 100 pazjent) Effetti sekondarji mhux komuni (inqas minn 1 kull 100 imma iktar minn 1 kull 1000 pazjent)
Some patients have experienced the following side effects after adding sitagliptin to metformin:
Xi pazjenti kellhom dawn l- effetti sekondarji wara li żiedu sitagliptin ma ’ metformin: