qanastek/EMEA-V3 huggingface dataset:
4 Change in clinical status of patients with previously controlled type 2 diabetes A patient with type 2 diabetes previously well controlled on Janumet who develops laboratory abnormalities or clinical illness (especially vague and poorly defined illness) should be evaluated promptly for evidence of ketoacidosis or lactic acidosis.
4 Bidla fl- istat kliniku ta ’ pazjenti b’ dijabete tip 2 li diġà kienu kkontrollati Pazjent b’ dijabete tip 2 li diġà kien ikkontrollat sewwa fuq Janumet li jiżviluppa anormalitajiet tal - laboratorju jew mard kliniku (speċjalment mard vag u mard mhux ċar biżżejjed) għandu jiġi evalwat minnufih għal evidenza ta ’ ketoaċidożi jew aċidożi lattika.
If acidosis of either form occurs, Janumet must be stopped immediately and other appropriate corrective measures initiated.
Jekk isseħħ aċidożi ta ’ forma waħda jew l- oħra, Janumet għandu jitwaqqaf minnufih u jinbdew miżuri korrettivi adattati
Pharmacokinetic drug interaction studies with Janumet have not been performed; however, such studies have been conducted with the individual active substances of Janumet, sitagliptin and metformin.
Ma sarux studji farmakokinetiċi ta ’ interazzjoni ta ’ mediċini b’ Janumet; madankollu, studji bħal dawn saru individwalment bis- sustanzi attivi ta ’ Janumet, sitagliptin u metformin.
There is increased risk of lactic acidosis in acute alcohol intoxication (particularly in the case of fasting, malnutrition or hepatic insufficiency) due to the metformin active substance of Janumet (see section 4.4).
B’ intossikazzjoni akuta ta ’ alkoħol (partikolarment fil- każ ta ’ sawm, malnutriment jew indeboliment epatiku) hemm żieda ta ’ riskju ta ’ aċidożi lattika minħabba s- sustanza attiva metformin bħala parti minn Janumet (ara sezzjoni 4. 4).
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 4.4).
Għaldaqstant, Janumet għandu jitwaqqaf qabel, jew fil- ħin 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. 4).
Janumet should not be used during pregnancy.
Janumet m’ għandux jintuża waqt it- tqala.
If a patient wishes to become pregnant or if a pregnancy occurs, treatment with Janumet should be discontinued and switched to insulin treatment as soon as possible.
Jekk pazjenta tixtieq li toħroġ tqila jew jekk isseħħ tqala, il - kura b’ Janumet għandha titwaqqaf u l- pazjenta għandha tinqaleb għal kura bl- insulina mill- aktar fis possibbli.
No studies in lactating animals have been conducted with the combined active substances of Janumet.
Ma sar l- ebda studju b’ sustanzi attivi kkumbinati ta ’ Janumet f’ annimali li qegħdin ireddgħu.
Janumet must therefore not be used in women who are breast-feeding (see section 4.3).
Janumet għalhekk m’ għandux jintuża f’ nisa li qegħdin ireddgħu (ara sezzjoni 4. 3).
No studies on the effects on the ability to drive and use machines have been performed with Janumet.
Ma sar l- ebda studju b’ Janumet fuq l- effetti fuq il- ħila biex issuq u li tħaddem magni.
In addition, patients should be alerted to the risk of hypoglycaemia when Janumet is used in combination with other sulfonylurea agents.
Barra minn hekk, il- pazjenti għandhom ikunu mwissija dwar ir- riskju ta ’ ipogliċemija meta Janumet jintuża f’ kumbinazzjoni ma ’ mediċini tat- tip sulfonylurea oħrajn.
There have been no therapeutic clinical trials conducted with Janumet tablets however bioequivalence of Janumet with co-administered sitagliptin and metformin has been demonstrated (see section 5.2).
Ma saru l- ebda provi terapewtiċi kliniċi b’ pilloli Janumet, madankollu ntweriet il- bijoekwivalenza ta ’ Janumet ma ’ sitagliptin u metformin mgħotijin flimkien (ara sezzjoni 5. 2).
2 In this 24-week placebo-controlled study of sitagliptin 100 mg once daily added to ongoing combination treatment with glimepiride and metformin, the overall incidence of adverse reactions
Fi studji ippuljati ta ’ żmien sa sena li qabblu sitagliptin miżjud ma ’ metformin li diġà jkun qiegħed jittieħed ma ’ mediċina sulphonylurea miżjuda ma ’ metformin li diġà jkun qiegħed jittieħed, reazzjonijiet avversi kkunsidrati bħala relatati mal- mediċina rrapportati f’ pazjenti kkurati b’ 100 mg
7 considered as drug-related in patients treated with the addition of sitagliptin to the ongoing treatment with glimepiride and metformin was 18.1% compared to treatment with the addition of placebo to the ongoing treatment with glimepiride and metformin which was 7.1%.
2 F’ dan l- istudju kkontrollat bi plaċebo ta ’ 24 ġimgħa ta ’ sitagliptin 100 mg darba kuljum miżjud ma ’ kura ta ’ kombinazzjoni ta ’ glimepiride u metformin li kompliet, l- inċidenza totali ta ’ reazzjonijiet avversi kkunsidrati bħala relatati mal- mediċina f’ pazjenti kkurati biż- żieda ta ’ sitagliptin mal- kura li tkun għadha qegħda tittieħed bi glimepiride u metformin kienet ta ’ 18. 1% meta mqabbla ma ’ kura biż- żieda ta ’ plaċebo mal- kura li tkun għadha qegħda tittieħed bi glimepiride u metformin li kienet 7. 1%.
During post-marketing experience of Janumet or sitagliptin, one of the active substances of Janumet, the following additional adverse reactions have been reported (frequency not known): hypersensitivity reactions including anaphylaxis, angioedema, rash, urticaria, and exfoliative skin conditions including Stevens-Johnson syndrome (see section 4.4).
Waqt ġbir ta dejta ta ’ wara t- tqegħid fis- suq ta ’ Janumet jew sitagliptin, wieħed mis- sustanzi attivi ta ’ Janumet, ġew irrapportati l- effetti sekondarji oħra li ġejjin (frekwenza mhux magħrufa): reazzjonijiet ta ’ sensittività eċċessiva li jinkludu anafilassi, anġjoedima, raxx, urtikarja, u kondizzjonijiet esfoljativi tal- ġilda inkluż is- sindromu ta ’ Stevens- Johnson (ara sezzjoni 4. 4).
8 Adverse reaction metallic taste
Togħma metallika
Gastrointestinal disorders
Disturbi gastro- intestinali sintomi gastrointestinalia
Skin and subcutaneous disorders urticaria, erythema, pruritis
Disturbi fil- ġilda u fit- tessuti ta ’ taħt il- ġilda
Metabolism and nutrition disorders
Disturbi fil- metaboliżmu u n- nutrizzjoni Rari ħafna aċidożi lattika Nuqqas ta ’ vitamina B12b
lactic acidosis vitamin B12 deficiencyb
Rari ħafna
Very rare Very rare
Disturbi fil- fwied u fil- marrara
Hepatobiliary disorders liver function disorders, hepatitis a
disturbi fil- funzjoni tal- fwied, epatite
Gastrointestinal symptoms such as nausea, vomiting, diarrhoea, abdominal pain occur most frequently during initiation of therapy and resolve spontaneously in b
Sintomi gastrointestinali bħalma huma dardir, remettar, dijarea, uġigħ addominali u telf ta ’ aptit a
and loss of appetite most cases.
seħħew l- aktar spiss waqt il- bidu ta ’ terapija u fil- parti l- kbira tal- każi rrisolvew ruħhom waħidhom.
No data are available with regard to overdose of Janumet.
Ma hemm l- ebda tagħrif disponibbli dwar teħid eċċessiv ta ’ Janumet.
Janumet combines two antihyperglycaemic agents with complementary mechanisms of action to improve glycaemic control in patients with type 2 diabetes: sitagliptin phosphate, a dipeptidyl peptidase 4 (DPP-4) inhibitor, and metformin hydrochloride, a member of the biguanide class.
Janumet jikkumbina żewġ mediċini kontra l- ipergliċemija b’ mekkaniżmi ta ’ azzjoni kumplimentari biex jitjieb il- kontroll gliċemiku f’ pazjenti b’ dijabete tip 2: sitagliptin phosphate, li hu impeditur dipeptidyl peptidase 4 (DPP- 4), u metformin hydrochloride, li hu membru tal- klassi biguanide.
Janumet A bioequivalence study in healthy subjects demonstrated that the Janumet (sitagliptin/ metformin hydrochloride) combination tablets are bioequivalent to co-administration of sitagliptin phosphate and metformin hydrochloride as individual tablets.
Janumet Studju ta ’ bijoekwivalenza f’ suġġetti b’ saħħithom wera li pilloli ta ’ kumbinazzjoni Janumet (sitagliptin/ metformin hydrochloride) huma bijoekwivalenti għal għoti konkomitanti ta ’ sitagliptin phosphate u metformin hydrochloride bħala pilloli individwali.
The following statements reflect the pharmacokinetic properties of the individual active substances of Janumet.
L- istqarrijiet li ġejjin jirriflettu l- kwalitajiet tas- sustanzi attivi individwali ta ’ Janumet.
No animal studies have been conducted with Janumet.
Ma sar l- ebda studju fl- annimali b’ Janumet.
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/ 015
16 EU/ 1/ 08/ 455/ 004 EU/ 1/ 08/ 455/ 005 EU/ 1/ 08/ 455/ 006 EU/ 1/ 08/ 455/ 007 EU/ 1/ 08/ 455/ 015
Janumet 50 mg/ 1000 mg film-coated tablets
Janumet 50 mg/ 1000 mg pilloli miksijin b’ rita
17 For the different doses on metformin, Janumet is available in strengths of 50 mg sitagliptin and 850 mg metformin hydrochloride or 1,000 mg metformin hydrochloride.
18 Għal dożi differenti ta ’ metformin, Janumet jinsab bħala 50 mg sitagliptin u 850 mg metformin hydrochloride jew 1000 mg metformin hydrochloride.
cardiac or respiratory failure, recent myocardial infarction, shock;
fallment kardijaku jew respiratorju, infart majokardjali reċenti, xokk;
19 Change in clinical status of patients with previously controlled type 2 diabetes A patient with type 2 diabetes previously well controlled on Janumet who develops laboratory abnormalities or clinical illness (especially vague and poorly defined illness) should be evaluated promptly for evidence of ketoacidosis or lactic acidosis.
20 Bidla fl- istat kliniku ta ’ pazjenti b’ dijabete tip 2 li diġà kienu kkontrollati Pazjent b’ dijabete tip 2 li diġà kien ikkontrollat sewwa fuq Janumet li jiżviluppa anormalitajiet tal - laboratorju jew mard kliniku (speċjalment mard vag u mard mhux ċar biżżejjed) għandu jiġi evalwat minnufih għal evidenza ta ’ ketoaċidożi jew aċidożi lattika.
22 considered as drug-related in patients treated with the addition of sitagliptin to the ongoing treatment with glimepiride and metformin was 18.1% compared to treatment with the addition of placebo to the ongoing treatment with glimepiride and metformin which was 7.1%.
2 F’ dan l- istudju kkontrollat bi plaċebo ta ’ 24 ġimgħa ta ’ sitagliptin 100 mg darba kuljum miżjud ma ’ kura ta ’ kombinazzjoni ta ’ glimepiride u metformin li kompliet, l- inċidenza totali ta ’ reazzjonijiet avversi kkunsidrati bħala relatati mal- mediċina f’ pazjenti kkurati biż- żieda ta ’ sitagliptin mal- kura li tkun għadha qegħda tittieħed bi glimepiride u metformin kienet ta ’ 18. 1% meta mqabbla ma ’ kura biż- żieda ta ’ plaċebo mal- kura li tkun għadha qegħda tittieħed bi glimepiride u metformin li kienet 7. 1%.
23 Adverse reaction metallic taste
Togħma metallika
24 Janumet combines two antihyperglycaemic agents with complementary mechanisms of action to improve glycaemic control in patients with type 2 diabetes: sitagliptin phosphate, a dipeptidyl peptidase 4 (DPP-4) inhibitor, and metformin hydrochloride, a member of the biguanide class.
Janumet jikkumbina żewġ mediċini kontra l- ipergliċemija b’ mekkaniżmi ta ’ azzjoni kumplimentari biex jitjieb il- kontroll gliċemiku f’ pazjenti b’ dijabete tip 2: sitagliptin phosphate, li hu impeditur dipeptidyl peptidase 4 (DPP- 4), u metformin hydrochloride, li hu membru tal- klassi biguanide.
Sitagliptin Sitagliptin phosphate is an orally-active, potent, and highly selective inhibitor of the dipeptidyl peptidase 4 (DPP-4) enzyme for the treatment of type 2 diabetes.
Sitagliptin Sitagliptin phosphate huwa impeditur attiv li jittieħed mill- ħalq, qawwi, ferm selettiv ta ’ l- enzim dipeptidyl peptidase 4 (DPP- 4) għall- kura ta ’ dijabete tip 2.
Risk Management Plan 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.
Pjan ta ’ Ġestjoni tar- Riskji Id- detentur ta ’ l- awtorizzazzjoni għat- tqegħid fis- suq jimpenja ruħu li jwettaq l- istudji u l- attivitajiet addizzjonali ta ’ farmakoviġilanza mogħtija fid- dettall fil- Pjan ta ’ Farmakoviġilanza, kif sar qbil fuqu fil- verżjoni 1. 1 tal- Pjan ta ’ Ġestjoni tar- Riskji (RMP) ppreżentat fil- Modulu 1. 8. 2. ta ’ l- Applikazzjoni għall- Awtorizzazzjoni għat- Tqegħid fis- Suq u għal kwalunkwe aġġornament sussegwenti tal- RMP miftiehem minn CHMP.
Outer carton for Janumet 50 mg/ 850 mg film-coated tablets
Pakkett ta ’ barra għal pilloli miksijin b’ rita Janumet 50 mg/ 850 mg
Janumet 50 mg/ 850 mg film-coated tablets sitagliptin/ metformin hydrochloride
Pilloli miksijin b’ rita Janumet 50 mg/ 850 mg sitagliptin/ metformin hydrochloride
EU/ 1/ 08/ 455/ 001 14 film-coated tablets EU/ 1/ 08/ 455/ 002 28 film-coated tablets EU/ 1/ 08/ 455/ 003 56 film-coated tablets EU/ 1/ 08/ 455/ 004 112 film-coated tablets EU/ 1/ 08/ 455/ 005 168 film-coated tablets EU/ 1/ 08/ 455/ 006 196 film-coated tablets EU/ 1/ 08/ 455/ 007 50 x 1 film-coated tablets EU/ 1/ 08/ 455/ 015 196 (2 x 98) film-coated tablets
EU/ 1/ 08/ 455/ 001 14- il pillola miksija b’ rita EU/ 1/ 08/ 455/ 002 28 pillola miksija b’ rita EU/ 1/ 08/ 455/ 003 56 pillola miksija b’ rita EU/ 1/ 08/ 455/ 004 112- il pillola miksija b’ rita EU/ 1/ 08/ 455/ 005 168 pillola miksija b’ rita EU/ 1/ 08/ 455/ 006 196 pillola miksija b’ rita EU/ 1/ 08/ 455/ 007 50 x 1 pillola miksija b’ rita EU/ 1/ 08/ 455/ 015 196 (2 x 98) pillola miksija b’ rita
Multi-packs of 196 (2 packs of 98 film-coated tablets) – without blue box - 50 mg/ 850 mg film- coated tablets
Pakketti multipli ta ’ 196 (2 pakketti ta ’ 98 pillola miksija b’ rita) – mingħajr kaxxa blu għal Janumet - 50 mg/ 850 mg pillola miksija b’ rita
Janumet 50 mg/ 850 mg film-coated tablets sitagliptin/ metformin hydrochloride
Janumet 50 mg/ 850 mg pillola miksija b’ rita sitagliptin/ metformin hydrochloride
39 MINIMUM PARTICULARS TO APPEAR ON BLISTERS
TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI
Blister for Janumet 50 mg/ 850 mg film-coated tablets
Folji għal pilloli miksijin b’ rita Janumet 50 mg/ 850 mg
Janumet 50 mg/ 850 mg tablets sitagliptin/ metformin HCl
Pilloli Janumet 50 mg/ 850 mg sitagliptin/ metformin hydrochloride
Outer carton for Janumet 50 mg/ 1,000 mg film-coated tablets
Pakkett ta ’ barra għal pilloli miksijin b’ rita Janumet 50 mg/ 1000 mg
Janumet 50 mg/ 1,000 mg film-coated tablets sitagliptin/ metformin hydrochloride
Pilloli miksijin b’ rita Janumet 50 mg/ 1000 mg sitagliptin/ metformin hydrochloride
14 film-coated tablets 28 film-coated tablets 56 film-coated tablets 112 film-coated tablets 168 film-coated tablets 196 film-coated tablets Multi-pack containing 196 (2 packs of 98) film-coated tablets 50 x 1 film-coated tablets
14- il pillola miksijin b’ rita 28 pillola miksija b’ rita 56 pillola miksija b’ rita 112- il pillola miksija b’ rita 168 pillola miksija b’ rita 196 pillola miksija b’ rita Pakkett multiplu li fih 196 (2 x 98) pillola miksija b’ rita 50 x 1 pillola miksija b’ rita
EU/ 1/ 08/ 455/ 008 14 film-coated tablets EU/ 1/ 08/ 455/ 009 28 film-coated tablets EU/ 1/ 08/ 455/ 010 56 film-coated tablets EU/ 1/ 08/ 455/ 011 112 film-coated tablets EU/ 1/ 08/ 455/ 012 168 film-coated tablets EU/ 1/ 08/ 455/ 013 196 film-coated tablets EU/ 1/ 08/ 455/ 014 50 x 1 film-coated tablets EU/ 1/ 08/ 455/ 016196 (2 x 98) film-coated tablets
EU/ 1/ 08/ 455/ 008 14- il pillola miksija b’ rita EU/ 1/ 08/ 455/ 009 28 pillola miksija b’ rita EU/ 1/ 08/ 455/ 010 56 pillola miksija b’ rita EU/ 1/ 08/ 455/ 011 112- il pillola miksija b’ rita EU/ 1/ 08/ 455/ 012 168 pillola miksija b’ rita EU/ 1/ 08/ 455/ 013 196 pillola miksija b’ rita EU/ 1/ 08/ 455/ 014 50 x 1 pillola miksija b’ rita EU/ 1/ 08/ 455/ 016 196 (2 pakketti ta ’ 98) pillola miksija b’ rita
Multi-packs of 196 (2 packs of 98 film-coated tablets) – without bleu box - 50 mg/ 1,000 mg film- coated tablets
Pakketti multipli ta ’ 196 (2 pakketti ta ’ 98 pillola miksija b’ rita) – mingħajr kaxxa blu għal Janumet - 50 mg/ 1, 000 mg pilloli miksijin b’ rita
Janumet 50 mg/ 1,000 mg film-coated tablets sitagliptin/ metformin hydrochloride
Janumet 50 mg/ 1, 000 mg pilloli miksijin b’ rita sitagliptin/ metformin hydrochloride
Blister for Janumet 50 mg/ 1,000 mg film-coated tablets
Folja għal pilloli miksijin b’ rita Janumet 50 mg/ 1000 mg
Janumet 50 mg/ 1,000 mg tablets sitagliptin/ metformin HCl
Pilloli Janumet 50 mg/ 1000 mg sitagliptin/ metformin hydrochloride
Janumet 50 mg/ 850 mg film-coated tablets sitagliptin/ metformin hydrochloride
Janumet 50 mg/ 850 mg pilloli miksijin b’ rita sitagliptin/ metformin hydrochloride
What Janumet is and what it is used for 2.
X’ inhu Janumet u għalxiex jintuża 2.
Before you take Janumet 3.
Qabel ma tieħu Janumet 3.
How to take Janumet 4.
Kif għandek tieħu Janumet 4.
How to store Janumet 6.
Kif taħżen Janumet 6.
WHAT JANUMET IS AND WHAT IT IS USED FOR
X’ INHU JANUMET U GĦALXIEX JINTUŻA
The name of your tablet is Janumet.
L- isem tal- pillola tiegħek hija Janumet.
Janumet helps to improve the levels of insulin after a meal and lowers the amount of sugar made by your body.
Janumet jgħin biex itejjeb il- livelli ta ’ insulina wara ikla u jbaxxi l - ammont ta ’ zokkor magħmul minn ġismek.
Janumet can be used alone or with another medicine for diabetes called a sulphonylurea.
Janumet jista ’ jintuża waħdu jew flimkien ma ’ mediċina oħra għad- dijabete msejħa sulphonylurea.
BEFORE YOU TAKE JANUMET
QABEL MA TIEĦU JANUMET
Do not take Janumet:
Tiħux Janumet:
Janumet (listed in section 6)
sustanzi oħra ta ’ Janumet (elenkati f’ sezzjoni 6)
47
Trid
- if you are going to have an X-ray where you will be injected with a dye.
tieqaf tieħu Janumet fil- ħin tar- raġġi- X u għal ftit jiem wara
taking Janumet at the time of the X-ray and for a few days after
49
Do not take Janumet if any of the above apply to you.
Tiħux Janumet jekk xi problema minn dawn tapplikaw għalik.
If you are not sure, talk to your doctor or pharmacist before taking Janumet.
Jekk m’ intix ċert, kellem lit- tabib jew l - ispiżjar tiegħek qabel tieħu Janumet.
Take special care with Janumet Check with your doctor or pharmacist before taking your medicine:
Oqgħod attent ħafna b’ Janumet Iċċekkja mat- tabib jew l- ispiżjar tiegħek qabel tieħu l- mediċina tiegħek:
Metformin hydrochloride, one of the ingredients in Janumet, can cause a rare but serious side effect called lactic acidosis (a build-up of lactic acid in the blood) that can cause death.
Metformin hydrochloride, wieħed mis- sustanzi f’ Janumet, jista ’ jikkaġuna effett sekondarju rari iżda serju msejjaħ aċidożi lattika (akkumulazzjoni ta ’ aċidu lattiku fid- demm) li tista ’ tkun ta ’ periklu.
If you experience some of the symptoms of lactic acidosis stop taking Janumet and consult a doctor immediately
Jekk tesperjenza xi wħud mis- sintomi ta ’ aċidożi lattika ieqaf milli tieħu Janumet u fittex parir ta ’ tabib minnufih
- During treatment with Janumet, your doctor will check your kidney function at least once a year
- Waqt kura b’ Janumet, it- tabib tiegħek sejjer jiċċekkja l- funzjoni tal- kliewi tiegħek ta ’ l- anqas
- if you have or have had an allergic reaction to sitagliptin, metformin, or Janumet
- Jekk għandek jew kellek reazzjoni alleġika għal sitagliptin, metformin, jew Janumet
- if you are taking a sulphonylurea, a diabetes medicine, together with Janumet, as you may
- Jekk barra Janumet qiegħed tieħu wkoll sulphonylurea, mediċina ta ’ kontra d- dijabete, flimkien
experience low blood sugar levels (hypoglycaemia).
ma ’ Janumet, għaliex jista ’ jkollok livelli ta ’ zokkor fid- demm baxxi (ipogliċemija).
need to stop taking Janumet for a couple of days before and after the procedure
jeħtieġ li tieqaf tieħu Janumet għal xi jiem qabel u wara l- proċedura
If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking Janumet.
Jekk m’ intix ċert jekk waħda minn dawn ta ’ hawn fuq japplikaw għalik, kellem lit- tabib jew lill - ispiżjar tiegħek qabel tieħu Janumet.
Taking Janumet with food and drink Take Janumet with meals to lower your chance of an upset stomach.
Meta tieħu Janumet ma ’ l- ikel u max- xorb Ħu Janumet ma ’ l- ikel biex tnaqqas iċ- ċans ta ’ taqliba ta ’ l- istonku
Pregnancy and breast-feeding Women who are pregnant or plan to become pregnant should talk to their doctor before taking Janumet.
Tqala u Treddigħ Nisa li huma tqal jew li qed jippjanaw li joħorġu tqal għandhom ikellmu lit- tabib tagħhom qabel ma jieħdu Janumet.
You should not use Janumet during pregnancy.
M’ għandekx tieħu Janumet waqt it- tqala.
It is not known if Janumet passes into human breast milk.
Mhuwiex magħruf jekk sitagliptin jgħaddix għal ġol- ħalib tas- sider tal - bniedem.
You must not use Janumet if you are breast-feeding or plan to breast-feed.
M’ għandekx tieħu Janumet jekk qegħda tredda ’ jew qegħda tippjana li tredda ’.
Driving and using machines No studies on the effects of Janumet on the ability to drive or to use machines have been performed.
50 Sewqan u tħaddim ta ’ magni Ma sar ebda studju fuq l- effetti ta ’ Janumet fuq il- ħila tiegħek biex issuq jew tħaddem magni.
Taking Janumet in combination with medicines called sulphonylureas can cause hypoglycaemia, which may affect your ability to drive and use machines or work without safe foothold.
It- teħid ta ’ Janumet f’ kumbinazzjoni ma ’ mediċini msejħin sulphonylureas jista ’ jikkaġuna ipogliċemija, li tista ’ taffettwa l- ħila tiegħek li ssuq u tuża magni jew taħdem f’ post li mhux sod biżżejjed.
HOW TO TAKE JANUMET
KIF GĦANDEK TIEĦU JANUMET
Always take Janumet exactly as your doctor has told you.
Dejjem ħu Janumet eżattament kif qallek it- tabib tiegħek.
• Janumet should be taken:
• Janumet għandu jittieħed:
• Continue to take Janumet as long as your doctor prescribes it so you can continue to help control your blood sugar.
• Kompli ħu Janumet sakemm jibqa ’ jiktibulek fuq ir- riċetta t- tabib tiegħek sabiex inti tibqa ’ tgħin tikkontrolla z- zokkor fid- demm.
You should continue your diet during treatment with Janumet and take care that your carbohydrate intake is equally distributed over the day.
Għandek tkompli d- dieta waqt kura b’ Janumet u tagħmel mezz li tqassam il- karboidrati ugwalment matul il- jum.
Janumet alone is unlikely to cause abnormally low blood sugar (hypoglycaemia).
Janumet waħdu mhuwiex mistenni li jikkawża livelli ta ’ zokkor fid- demm baxxi ħafna (ipogliċemija).
When Janumet is used with a sulphonylurea medicine, low blood sugar can occur and your doctor may reduce the dose of your sulphonylurea.
Meta Janumet jintuża ma ’ mediċina tat- tip sulphonylurea, jista ’ jseħħ livell baxx ta ’ zokkor fid- demm u t- tabib tiegħek jista ’ jnaqqas id- doża ta ’ sulphonylurea li tkun qed tieħu.
If you take more Janumet than you should If you take more than the prescribed dosage of Janumet, contact your doctor immediately.
Jekk tieħu Janumet aktar milli suppost Jekk tieħu aktar Janumet mid- dożaġġ miktub fir- riċetta, ikkuntattja lit- tabib tiegħek minnufih.
If you forget to take Janumet If you miss a dose, take it as soon as you remember.
Jekk tinsa tieħu Janumet Jekk tinsa tieħu doża, ħudha mill- aktar fis malli tiftakar.
Do not take a double dose of Janumet.
Tiħux doża doppja ta ’ Janumet.
Like all medicines, Janumet may cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, Janumet jista ’ jkollu effetti sekondarji, għalkemm mhux kulħadd ikollu.
Very rarely patients taking metformin (one of the active substances of Janumet) have experienced a serious condition called lactic acidosis (too much lactic acid in your blood).
Rari ħafna, pazjenti li jkunu qegħdin jieħdu metformin (wieħed mis- sustanzi attivi ta ’ Janumet) ikollhom kundizzjoni serja msejħa aċidożi lattika (wisq aċidu lattiku fid- demm).
Stop taking Janumet and see a doctor straight away if you notice any of the following symptoms: • feeling sick (nausea) or being sick (vomiting), abdominal pain, muscular cramps, unexplained weight loss, rapid breathing, and feeling cold or uncomfortable.
Waqqaf Janumet u ara tabib minnufih jekk tara xi sintomi minn dawn li ġejjin: • ikollok dardir jew tirremetti, jew ikollok uġigħ ta ’ żaqq, bugħawwieġ, telf ta ’ piż mhux mistenni, nifs mgħaġġel u tħoss tkexkix ta ’ bard jew skumdità.
Some patients have experienced the following side effects while taking Janumet with a sulphonylurea:
Xi pazjenti kellhom l- effetti sekondarji li ġejjin waqt li kienu qegħdin jieħdu Janumet ma ’ sulphonylurea:
During post-marketing experience with Janumet or sitagliptin, one of the medicines in Janumet, the following side effects have also been reported (frequency not known): allergic reactions, which may be serious, including rash, hives, and swelling of the face, lips, tongue, and throat that may cause difficulty in breathing or swallowing.
Waqt sorveljanza ta ’ wara t- tqegħid fis- suq b’ Janumet jew sitagliptin, waħda mill- mediċini f’ Janumet, ġew irrapportati wkoll l- effetti sekondarji li ġejjin (frekwenza mhux magħrufa): reazzjonijiet allerġiċi, inklużi raxx, urtikarja, u nefħa tal- wiċċ, xofftejn, ilsien, u ġerżuma li jistgħu jikkaġunaw diffikultà biex tieħu n- nifs jew biex tibla ’.
If you have an allergic reaction, stop taking Janumet and call your doctor right away.
Jekk ikollok reazzjoni allerġika, waqqaf Janumet u sejjaħ lit- tabib tiegħek minnufih.
HOW TO STORE JANUMET
KIF TAĦŻEN JANUMET
Do not use Janumet after the expiry date which is stated on the blister and the carton.
Tużax Janumet wara d- data ta ’ skadenza li tidher fuq il- folja u l- kartuna.
What Janumet contains
X’ fih Janumet
What Janumet looks like and contents of the pack
Id- dehra ta ’ Janumet u l- kontenut tal- pakkett:
Janumet 50 mg/1000 mg film-coated tablets sitagliptin/metformin hydrochloride
Janumet 50 mg/ 1000 mg pilloli miksijin b’ rita sitagliptin/ metformin hydrochloride
taking Janumet at the time of the X -ray and for a few days after
tieqaf tieħu Janumet fil- ħin tar- raġġi- X u għal ftit jiem wara
55 Metformin passes into human milk in small amounts.
57 Metformin jgħaddi fil- ħalib tal- omm f’ ammonti żgħar.
Driving and using machines No studies on the effects of Janumet on the ability to drive or to use machines have been performed.
Sewqan u tħaddim ta ’ magni Ma sar ebda studju fuq l- effetti ta ’ Janumet fuq il- ħila tiegħek biex issuq jew tħaddem magni.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
58 Jekk għandek aktar mistoqsijiet dwar l- użu ta ’ dan il- prodott, staqsi lit- tabib jew lill- ispiżjar tiegħek.
Very common: nausea, vomiting, diarrhoea, abdominal pain and loss of appetite Common: a metallic taste Very rare: decreased vitamin B12 levels, hepatitis (a problem with your liver), redness of the skin (rash) or itching, lactic acidosis (excess of lactic acid in your blood) particularly in patients whose kidneys are not working properly.
Komuni ħafna: dardir, remettar, dijarea, uġigħ ta ’ żaqq u telf fl- aptit Komuni: togħma metallika Rari ħafna: tnaqqis fil- livelli ta ’ vitamina B12, epatite (problema tal- fwied), ħmura tal- ġilda (raxx) jew ħakk, aċidożi lattika (eċċess ta ’ aċidu lattiku fid- demm) partikolarment f’ pazjenti li l- kliewi tagħhom
Packs of 14, 28, 56, 112, 168, 196 ilm-coated tablets, multi-packs containing 196 (2 acks of 98) film-coated tablets.
Pakketti ta ’ 14, 28, 56, 112, 168, 196 pillola miksija b’ rita, pakketti multipli li fihom 196 (2 pakketti ta ’ 98) pillola miksija b’ rita.
België/Belgique/Belgien Merck Sharp & Dohme B.V.
60 België/ Belgique/ Belgien Merck Sharp & Dohme B. V.
Ιtalia Merck Sharp & Dohme (Italia) S.p.A.
61 Ιtalia Merck Sharp & Dohme (Italia) S. p. A.
EPAR summary for the public
JANUVIA Sommarju ta 'l- EPAR għall- pubbliku
What is Januvia?
X' inhi Januvia?
Januvia is a medicine containing the active substance sitagliptin.
Januvia hija mediċina li fiha s- sustanza attiva sitagliptin.
It is available as round tablets.
Tiġi bħala pilloli tondi.
What is Januvia used for?
Għal xiex tintuża Januvia?
Januvia is used to treat patients with type 2 diabetes, to improve control of blood sugar levels.
Januvia tintuża għat- trattament ta 'pazjenti b' dijabete tat- tip 2, sabiex ittejjeb il- kontroll tal- livelli taz - zokkor fid- demm.
It is used with diet and exercise, together with one or more antidiabetes medicines: • in combination with metformin, in patients who are not satisfactorily controlled on metformin alone; • in combination with a sulphonylurea in patients who are not satisfactorily controlled with a sulphonylurea alone and in whom metformin is not suitable; • in combination with both metformin and a sulphonylurea, when both medicines are not sufficient to give satisfactory control of the patient ’ s diabetes; • in combination with a PPAR gamma agonist, such as a thiazolidinedione, in patients who are not satisfactorily controlled on the PPAR gamma agonist alone.
Tintuża ma 'dieta u eżerċizzju, flimkien ma' mediċina oħra jew aktar kontra d - dijabete, • f' kombinazzjoni mal- metformina [metformin], f' pazjenti li mhumiex ikkontrollati biżżejjed bil - metformina biss; • f' kombinazzjoni mas- sulfonilurea [sulphonylurea] f' pazjenti li mhumiex ikkontrollati biżżejjed bis- sulfonilurea biss u li għalihom il- metformina mhijiex adegwata; • f' kombinazzjoni mal- metformina u s- sulfonilurea, meta ż- żewġ mediċini mhumiex biżżejjed biex jikkontrollaw b' mod sodisfaċenti d- dijabete ta 'pazjent; • f' kombinazzjoni ma' agonista PPAR- gamma [PPAR gamma agonist], bħat- thiazolidinedione, f' pazjenti li mhumiex ikkontrollati b' mod sodisfaċenti bl- agonista PPAR- gamma biss.
The medicine can only be obtained with a prescription.
Il- mediċina tista 'tinkiseb biss b' riċetta.
How is Januvia used?
Kif tintuża Januvia?
Januvia is taken at a dose of 100 mg once a day, with or without food.
Januvia tittieħed b' doża ta '100 mg darba kuljum, waħedha jew ma' l- ikel.
There is no need to change the doses of the other medicines Januvia is taken with, except when Januvia is taken with a sulphonylurea.
Mhuwiex meħtieġ li jiġu modifikati d- dożi tal- mediċini l- oħra li magħhom tittieħed Januvia, ħlief meta Januvia tittieħed ma 'sulfonilurea.
In such cases, the dose of the sulphonylurea may be lowered to reduce the risk of hypoglycaemia (low blood sugar levels).
F' każijiet bħal dawn, huwa possibbli li titnaqqas id- doża ta 'sulfonilurea biex jitbaxxa r - riskju ta' ipogliċemija (livelli baxxi ta 'zokkor fid- demm)..
Januvia is not recommended for use in patients who have moderate or severe problems with their kidneys, or in patients aged less than 18 years.
L- użu ta 'Januvia mhuwiex rakkomandat għal pazjenti li għandhom problemi bil- kliewi moderati għal gravi, jew f' pazjenti li għandhom inqas minn 18- il sena.
How does Januvia work?
Kif taħdem Januvia?
Type 2 diabetes is a disease in which the pancreas does not make enough insulin to control the level of glucose (sugar) in the blood or when the body is unable to use insulin effectively.
Id- dijabete tat- tip 2 hija marda li fiha, il- frixa (pankreas) ma tipproduċix biżżejjed insulina biex tikkontrolla l- livell ta 'glukożju (zokkor) fid- demm jew meta l- ġisem ma jużax l- insulina b' mod effikaċi.
It works by blocking the breakdown of ‘ incretin’ hormones in the body.
Is- sustanza attiva f' Januvia, sitagliptin, hija inibitur tat- tip tad- dipeptidil- peptidażi 4 (DPP- 4, dipeptidyl peptidase 4).
Sitagliptin does not work when the blood sugar is low.
Taħdem billi timblokka d- degradazzjoni ta 'ormoni ta' l - 'inkretina' fil- ġisem.
Sitagliptin also reduces the amount of sugar made by the liver, by increasing insulin levels and decreasing the levels of the hormone glucagon.
Dawn l- ormoni jiġu rilaxxati wara ikla u jistimulaw il- frixa sabiex tipproduċi l- insulina.
Together, these processes reduce blood glucose levels and help to control type 2 diabetes.
Billi żżid il - livelli ta 'l- ormoni ta' l- inkretina fid- demm, sitagliptin jistimula l- frixa sabiex tipproduċi aktar insulina meta l- livelli taz- zokkor fid- demm ikunu għoljin.
7 Westferry Circus, Canary Wharf, London, E14 4HB, UK Tel.
Sitagliptin ma taħdimx meta l- livell ta 'zokkor fi - 7 Westferry Circus, Canary Wharf, London, E14 4HB, UK Tel.
Reproduction is authorised provided the source is acknowledged.
Reproduction is authorised provided the source is acknowledged. demm ikun wieħed baxx.
How has Januvia been studied?
Kif ġiet studjata Januvia?
The effects of Januvia were first tested in experimental models before being studied in humans.
Għall- ewwel, l- effetti ta 'Januvia ġew ittestjati f' mudelli sperimentali qabel ġew studjati fuq il - bnedmin.
Januvia was studied in five main studies lasting up to a year, involving almost 4,000 patients with type 2 diabetes whose blood sugar levels were not adequately controlled.
Januvia ġiet studjata fil- ħames studji prinċipali li damu sa sena, u li involvew kważi 4, 000 pazjent bid- dijabete tat- tip 2 li l- livelli ta 'zokkor fid- demm tagħhom ma kinux ikkontrollati b' mod adegwat.
Four of the studies compared Januvia to placebo (a dummy treatment), either taken alone (two studies involving 1,262 patients), or as an add-on to metformin (in 702 patients) or to the PPAR gamma agonist pioglitazone (in 353 patients).
Erbgħa mill- istudji qabblu Januvia mal- plaċebo (trattament finta), jew meta tittieħed waħedha (żewġ studji li involvew 1, 262 pazjent), jew meta miżjuda mal- metformina (f' 702 pazjenti) jew mal- pioglitazone agonista tal- PPAR- gamma (fi 353 pazjent).
The fifth study compared Januvia to glipizide (a sulphonylurea), as an add-on to metformin in 1,172 patients.
Il- ħames studju qabbel Januvia ma 'glipizide (sulfonilurea), bħala żieda mal- metformina f' 1, 172 pazjent.
An additional study compared Januvia to placebo, when used as an add-on to treatment with glimepiride (another sulphonylurea), with or without metformin, in 441 patients.
Studju addizzjonali qabbel Januvia ma 'plaċebo, meta użat bħala żieda mat- trattament bil- glimepiride (sulfonilurea oħra), bil - metformina jew mingħajrha, f' 441 pazjent.
In all studies, the main measure of effectiveness was the change in the level of a substance in the blood called glycosylated haemoglobin (HbA1c), which gives an indication of how well the blood glucose is controlled.
Fl- istudji kollha, il- kejl prinċipali ta 'l- effikaċja kien il - bidla fil- livell ta' sustanza fid- demm imsejħa emoglobina glikosilata (glycosylated haemoglobin, HbA1c), li tagħti indikazzjoni ta 'kemm il- glukożju fid- demm huwa kkontrollat.
What benefit has Januvia shown during the studies?
X' benefiċċju wriet Januvia matul l- istudji?
Januvia was more effective than placebo when it was taken alone or in combination with other antidiabetes medicines.
Januvia kienet aktar effikaċi mill- plaċebo meta ttieħdet waħedha jew flimkien ma 'mediċina oħra kontra d- dijabete.
In combination with metformin, a daily dose of 100 mg Januvia reduced HbA1c by 0.70% (from 7.96 to 7.26%) after 24 weeks, compared to a fall of 0.08% in the patients adding placebo.
F' kombinazzjoni mal- metformina, doża ta 'kuljum ta' 100 mg Januvia naqset l- HbA1c b' 0. 70% (minn 7. 96 għal 7. 26%) wara 24 ġimgħa, meta mqabbla ma 'tnaqqis ta' 0. 08% fil- pazjenti li ħadu wkoll il - plaċebo.
In combination with pioglitazone, 100 mg Januvia reduced HbA1c levels by 0.88% after 24 weeks, compared to 0.18% in the patients adding placebo.
F' kombinazzjoni mal- pioglitazone, doża ta '100mg Januvia naqset il- livelli ta' HbA1c b' 0. 88% wara 24 ġimgħa, meta mqabbla ma 'tnaqqis ta' 0. 18% fil- pazjenti li ħadu wkoll il- plaċebo.
In the study comparing Januvia and glipizide as an add-on to metformin, glipizide was initially more effective than Januvia in reducing HbA1c levels.
Fl - istudju li jqabbel Januvia u glipizide miżjud mal- metformina, fil- bidu, glipizide kien aktar effikaċi minn Januvia fit- tnaqqis tal- livelli ta 'HbA1c.
However, in patients continuing to take Januvia or glipizide, the two medicines had similar levels of effectiveness after a year of treatment.
Madankollu, f' pazjenti li baqgħu jieħdu Januvia jew glipizide, iż- żewġ mediċini kellhom livelli simili ta 'effikaċja wara sena ta' trattament.
Januvia was also more effective than placebo when it was added to glimepiride (with and without metformin).
Januvia kien ukoll aktar effikaċi mill- plaċebo meta żdiedet ma 'glimepiride (bil- metformina jew mingħajrha).
This reduced HbA1c levels after 24 weeks by 0.30% in patients receiving Januvia and glimepiride, and by 0.60% in the patients who were also taking also taking metformin in addition to Januvia and glimepiride.
Wara 24 siegħa, dan naqqas il- livelli ta 'HbA1c b' 0. 30% fil- pazjenti li ħadu Januvia u glimepiride u b' 0. 60% f' pazjenti li ħadu wkoll il- metformina flimkien ma' Januvia u glimepiride.
What is the risk associated with Januvia?
X' inhu r- riskju assoċjat ma 'Januvia?
This is seen in more than 1 patient in 10 when Januvia is taken with a sulphonylurea (with or without metformin) and in between 1 and 10 patients in 100 when Januvia is taken with a PPAR gamma agonist.
L- aktar effett sekondarju komuni meta Januvia tittieħed ma 'mediċini oħra huwa l- ipogliċemija, osservata f' aktar minn pazjent wieħed minn għaxra meta Januvia tittieħed mas- sulfonilurea (bil - metformina jew mingħajrha) u bejn pazjent wieħed u għaxra minn 100 meta Januvia tittieħed ma' agonista PPAR- gamma.
When Januvia is taken with metformin only, the most common side effect (seen in between 1 and 10 patients in 100) is nausea (feeling sick).
Meta Januvia tittieħed mal- metformina biss, l- aktar effett sekondarju komuni (osservat f' bejn wieħed u għaxar pazjenti minn 100) hija n- nawżea (dardir).
For the full list of all side effects reported with Januvia, see the Package Leaflet.
Għal- lista sħiħa ta 'l- effetti sekondarji kollha rrapportati b' Januvia, ara l- Fuljett ta' Tagħrif.
Januvia should not be used in people who may be hypersensitive (allergic) to sitagliptin or any of the other ingredients.
Januvia ma għandhiex tintuża f' persuni li aktarx ikunu ipersensittivi (allerġiċi) għal sitagliptin jew għal xi sustanza oħra.
Why has Januvia been approved?
Għaliex ġiet approvata Januvia?
The Committee for Medicinal Products for Human Use (CHMP) decided that Januvia’ s benefits are greater than its risks for the treatment of patients with type 2 diabetes mellitus to improve glycaemic control in combination with metformin and/ or a sulphonylurea, or a PPAR gamma agonist, when diet and exercise plus the other medicines do not provide adequate glycaemic control.
Il- Kumitat għall- Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) iddeċieda li l- benefiċċji ta 'Januvia huma aktar mir- riskji tagħha għat- trattament ta' pazjenti bid- dijabete mellitu tat- tip 2 sabiex ittejjeb il- kontroll gliċemiku f' kombinazzjoni mal- metformina u/ jew sulfonilurea, jew agonista PPAR - gamma, meta dieta u eżerċizzju flimkien ma 'mediċina waħda ma jipprovdux kontroll gliċemiku adegwat.
The Committee recommended that Januvia be given marketing authorisation.
Il- Kumitat irrakkomanda li Januvia għandu jingħata l- awtorizzazzjoni għat- tqegħid fis- suq.
Other information about Januvia:
Tagħrif ieħor dwar Januvia:
The European Commission granted a marketing authorisation valid throughout the European Union for Januvia to Merck Sharp & Dohme Ltd. on 21 March 2007.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fis- suq valida madwar l- Unjoni Ewropea kollha, għal Januvia lil Merck Sharp & Dohme Ltd fil- 21 ta 'Marzu 2007.
The full EPAR for Januvia can be found here.
EPAR sħiħ għal Januvia huwa disponibbli minn hawn.
Januvia 25 mg film-coated tablets
Januvia pilloli miksija b’ rita tal- 25 mg
Each tablet contains sitagliptin phosphate monohydrate, equivalent to 25 mg sitagliptin.
Kull pillola fiha sitagliptin phosphate monohydrate, ekwivalenti għal 25 mg ta ’ sitagliptin.
For a full list of excipients, see section 6.1.
Għal lista kompleta ta’ sustanzi mhux attivi, ara sezzjoni 6. 1.
Film-coated tablet (tablet)
Pillola miksija b’ rita (pillola)
Round, pink film-coated tablet with “ 221” on one side.
Pillola tonda u roża miksija b’ rita bi “ 221 ” fuq naħa waħda.
For patients with type 2 diabetes mellitus, Januvia is indicated:
Għal pazjenti bid- dijabete mellitus tat- tip 2, Januvia huwa indikat:
• to improve glycaemic control in combination with metformin when diet and exercise plus metformin alone do not provide adequate glycaemic control.
• biex ittejjeb il- kontrol gliċemiku flimkien ma ’ metformin meta d- dieta u l- eżerċizzju, flimkien ma ’ metformin waħdu ma jipprovdux kontroll gliċemiku adegwat.
• to improve glycaemic control in combination with a sulphonylurea when diet and exercise plus maximal tolerated dose of a sulphonylurea alone do not provide adequate glycaemic control and when metformin is inappropriate due to contraindications or intolerance.
• biex ittejjeb il- kontrol gliċemiku flimkien ma ’ sulphonylurea meta d- dieta u l- eżerċizzju flimkien ma ’ doża massima tollerata ta ’ sulphonylurea waħedhom ma jipprovdux kontroll gliċemiku adegwat u meta metformin ma jkunx adegwat minħabba kontraindikazzjonijiet jew intolleranza.
• to improve glycaemic control in combination with a sulphonylurea and metformin when diet and exercise plus dual therapy with these agents do not provide adequate glycaemic control.
• biex ittejjeb il- kontroll gliċemiku flimkien ma ’ sulphonylurea u metformin meta d- dieta u l - eżerċizzju flimkien ma ’ terapija b’ dawn iż- żewġ aġenti ma jipprovdux kontroll gliċemiku adegwat.
For patients with type 2 diabetes mellitus in whom use of a PPARγ agonist (i. e. a thiazolidinedione) is appropriate, Januvia is indicated:
Għal pazjenti bid- dijabete mellitus tat- tip 2 li għalihom huwa f’ waqtu l- użu ta ’ agonist PPARγ (i. e. thiazolidinedione) Januvia huwa indikat:
• in combination with the PPARγ agonist when diet and exercise plus the PPARγ agonist alone do not provide adequate glycaemic control.
• flimkien ma ’ l- agonist PPARγ meta d- dieta u l- eżerċizzju, flimkien ma ’ agonist PPARγ ma jipprovdux kontroll gliċemiku adegwat.
The dose of Januvia is 100 mg once daily.
Id- doża ta ’ Januvia hija 100 mg darba kuljum.
The dosage of metformin or PPARγ agonist should be maintained, and sitagliptin administered concomitantly.
Id- dożaġġ ta ’ metformin jew l- agonist PPARγ għandu jinżamm, u sitagliptin tinghata miegħu.
When Januvia is used in combination with a sulphonylurea, a lower dose of the sulphonylurea may be considered to reduce the risk of hypoglycaemia.
Meta Januvia jintuża flimkien ma ’ sulphonylurea, tista ’ titqies doża iżgħar ta ’ sulphonylurea biex jitnaqqas ir- riskju ta ’ ipogliċemija.
(See section 4.4.)
(Ara sezzjoni 4. 4)
If a dose of Januvia is missed, it should be taken as soon as the patient remembers.
Jekk tinqabeż doża ta ’ Januvia, għandha tittieħed kif jiftakar il- pazjent.
A double dose should not be taken on the same day.
M’ għandhiex tittieħed doża doppja fl- istess ġurnata.
Januvia can be taken with or without food.
Januvia tista ’ tittieħed ma ’ l- ikel jew mingħajr ikel.
2 Patients with renal insufficiency For patients with mild renal insufficiency (creatinine clearance [CrCl] ≥ 50 ml/ min), no dosage adjustment for Januvia is required.
2 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.
Clinical study experience with Januvia in patients with moderate or severe renal insufficiency is limited.
Esperjenza minn studji kliniċi b’ Januvia f’ pazjenti b’ insuffiċjenza renali moderata jew qawwija hi limitata.
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 'pazjent (ara sezzjoni 5. 2).
Januvia has not been studied in patients with severe hepatic insufficiency.
Pazjenti b’ insuffiċjenza epatika M’ hemmx għalfejn bidla fid- doża għal pazjenti li għandhom insuffiċjenza epatika ħafifa jew moderata Januvia ma ġiex studjat f’ pazjenti b’ insuffiċjenza epatika qawwija.
Elderly No dosage adjustment is necessary based on age.
Anzjani M’ hemmex għalfejn bidla fid- doża minħabba l- età.
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
Paediatric population Januvia is not recommended for use in children below 18 years of age due to a lack of data on its safety and efficacy.
Popolazzjoni pedjatrika Januvia mhux rakkomandat ghal użu fit- tfal taħt it- 18- il sena minħabba nuqqas ta ’ informazzjoni dwar is- sigurtà u l- effikaċja.
Hypersensitivity to the active substance or to any of the excipients (see section 4.4 and 4.8).
Sensittività eċċessiva għas- sustanza attiva jew għal xi sustanzi mhux attivi (ara sezzjoni 4. 4 u 4. 8).
General Januvia should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis.
Ġenerali Januvia m’ għandhiex tintuża f ’ pazjenti bid- dijabete ta ’ tip 1 jew għall- kura ta ’ ketoaċidożi dijabetika.
Hypoglycaemia when used in combination with other anti-hyperglycaemic agents In clinical trials of Januvia as monotherapy and as part of combination therapy with agents not known to cause hypoglycaemia (i. e. metformin or pioglitazone), rates of hypoglycaemia reported with sitagliptin were similar to rates in patients taking placebo.
Ipogliċemija meta wżat f’ kombinazzjoni ma ’ sustanzi anti- iperglimiċi oħrajn Fi provi kliniċi ta ’ Januvia bħala terapija waħedha u f’ terapija flimkien ma ’ aġenti li mhumiex magħrufin li jikkawżaw ipogliċemija (i. e. metformin jew pioglitazone), ir- rati ta ’ ipogliċemija li ġew irrappurti b’ sitagliptin kienu simili għal pazjenti li kienu qed jieħdu plaċebo.
When sitagliptin was added to a sulphonylurea, the incidence of hypoglycaemia was increased over that of placebo (see section 4.8).
Meta sitagliptin ġiet miżjuda ma ’ sulphonylurea, l- inċidenza ta ’ ipogliċemija kibret meta mqabbla ma ’ plaċebo (ara sezzjoni 4. 8).
Therefore, to reduce the risk of hypoglycaemia, a lower dose of sulphonylurea may be considered (see section 4.2).
Għalhekk, biex jitnaqqas ir- riskju ta ’ ipogliċemija, għandha titqies doża iżgħar ta ’ sulphonylurea (ara sezzjoni 4. 2).
The use of sitagliptin in combination with insulin has not been adequately studied.
L- użu ta ’ sitagliptin flimkien ma ’ insulina ma ġiex studjat biżżejjed.
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 renali moderata jew severa m’ għandhomx jiġu kkurati b’ Januvia (ara sezzjoni 5. 2).
Hypersensitivity Reactions Postmarketing reports of serious hypersensitivity reactions in patients treated with Januvia have been reported.
Reazzjonijiet ta ’ Sensittività Eċċessiva Ġew irrapportati rapporti ta ’ reazzjonijiet ta ’ sensittività eċċessiva ta ’ wara t- tqegħid fis- suq f’ pazjenti ttrattati b’ Januvia.
These reactions include anaphylaxis, angioedema, and exfoliative skin conditions including Stevens-Johnson syndrome.
Dawn ir- reazzjonijiet jinkludu anafilassi, anġjodema u kundizzjonijiet ta ’ ġilda li titqaxxar inkluż is- sindromu ta ’ Stevens- Johnson.
Onset of these reactions occurred within the first 3 months after initiation of treatment with Januvia, with some reports occurring after the first dose.
Il- bidu ta ’ dawn ir- reazzjonijiet seħħ fl- ewwel 3 xhur wara l- bidu tat- trattament b’ Januvia, b’ xi rapporti jseħħu wara l- ewwel doża.
If a hypersensitivity reaction is suspected, discontinue Januvia, assess for other potential causes for the event, and institute alternative treatment for diabetes.
Jekk ikun hemm suspett ta ’ reazzjoni ta ’ sensittività eċċessiva, waqqaf Januvia, iċċekkja kawżi potenzjali oħrajn għall - episodju, u ibda trattament alternattiv għad- dijabete.
(See section 4.8).
(Ara sezzjoni 4. 8).
Effects of other medicinal products on sitagliptin Clinical data described below suggest that the risk for clinically meaningful interactions by co- administered medicinal products is low.
Effetti ta ’ mediċini oħra fuq sitagliptin It- tagħrif kliniku ta ’ hawn taħt jagħti x’ jifhem li r- riskju ta ’ interazzjonijiet b’ relevanza klinika ma ’ prodotti mediċinali mogħtija flimkien huwa baxx.