qanastek/EMEA-V3 huggingface dataset:
Italia Via fratalli Cervi snc, Centro Direzionale Milano Due Palazzo Borromini I-20090 Segrate (Milano) Tel: + 39-02 21018.1
Suomi/ Finland Italia PL 86/ PB 86 Via fratalli Cervi snc, FIN- 02151 Espoo/ Esbo Centro Direzionale Milano Due Puh/ Tel: + 358 - (0) 20- 7570 300 Palazzo Borromini I- 20090 Segrate (Milano) Tel: + 39- 02 21018. 1
Detailed information on this medicinal product is available on the website of the European Medicines Agency (EMEA) http://www.emea.europa.eu/
Informazzjoni ddettaljata dwar din il- mediċina tinsab fuq il- website ta ’ l- Aġenzija Ewropeja dwar il - Mediċini (EMEA) http: // www. emea. europa. eu /.
203 The following information is intended for medical or health care professional use only:
204 L- informazzjoni li ġejja qed tingħata għall- użu minn professjonisti fil- qasam mediku jew fil- kura tas- saħħa biss:
Reconstituted product must be used within 14 hours, including infusion time.
Il- prodott li jkun ġie mħallat għandu jintuża fi żmien 14- il siegħa, inkluż il- ħin għall- infużjoni.
A volume up to 40 ml reconstituted solution should be withdrawn, according to the total prescribed dose and transferred into an empty 250 ml PVC infusion bag.
Volum sa 40 ml tas- soluzzjoni mħallta għandu jinġibed, skond id- doża totali ordnata u ttrasferit ġo borża ta ’ l- infużjoni vojta tal- PVC ta ’ 250 ml.
Temodal 2.5 mg/ml must be administered by intravenous infusion only over a period of 90 minutes.
Temodal 2. 5 mg/ ml għandu jingħata biss permezz ta ’ infużjoni għal- ġol vina fuq perijodu ta ’ 90 minuta.
In absence of compatibility studies this medicinal product must not be mixed with other medicinal products or infused simultaneously through the same intravenous line.
Fin- nuqqas ta ’ studji dwar kompatibilità, dan il- prodott mediċinali m’ għandux jitħallat ma ’ prodotti mediċinali oħrajn jew jingħata fl- istess tubi li intużaw għal infużjoni oħra.
What is TESAVEL?
X' inhu TESAVEL?
TESAVEL is a medicine containing the active substance sitagliptin.
TESAVEL hija mediċina li fiha s- sustanza attiva sitagliptin.
This medicine is the same as Januvia, which is already authorised in the European Union (EU).
Din il- mediċina hija l- istess bħal Januvia, li hija diġà awtorizzata fl- Unjoni Europea (UE).
The company that makes Januvia has agreed that its scientific data can be used for TESAVEL.
Il - kumpanija li tagħmel Januvia qablet li l- informazzjoni xjentifika tagħha tista ’ tintuża għal TESAVEL.
What is TESAVEL used for?
Għal x' hiex Tintuża TESAVEL?
TESAVEL is used to treat patients with type 2 diabetes, to improve control of blood sugar levels.
TESAVEL 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 flimkien ma ’ dieta u eżerċizzju, flimkien ma ’ mediċina waħda jew aktar kontra d- dijabete: • Flimkien ma ’ ma ’ metformin, f’ pazjenti li mhumiex kontrollati tajjeb fuq il- metformin biss; • Flimkien ma ’ ma ’ sulphonylurea f’ pazjenti li mhumiex kontrollati tajjeb b’ sulphonylurea biss u li metoformin mhux tajjeb għalihom; • Flimkien ma ’ kemm ma ’ metformin u sulphonylurea meta ż- żewġ mediċini mhumiex biżżejjed sabiex jagħtu kontroll sodisfaċenti għad- dijabete tal- pazjent. • Flimkien ma ’ ma ’ PPAR gamma agonist, bħal thiazolidinedione, f’ pazjenti li mhumiex kontrollati biżżejed bil- PPAR gamma agonist biss.
How is TESAVEL used?
Kif jintuża TESAVEL?
TESAVEL is taken at a dose of 100 mg once a day, with or without food.
TESAVEL tittieħed b' doża ta '100 mg darba kuljum, ma l- ikel jew mhux ma' l- ikel.
There is no need to change the doses of the other medicines TESAVEL is taken with, except when TESAVEL is taken with a sulphonylurea.
M’ hemmx bżonn isir tibdil fid- dożi ta ’ mediċini oħrajn li magħhom tittieħed TESAVEL, ħlief meta TESAVEL hija meħuda bis- sulphonylurea.
In such cases, the dose of the sulphonylurea may be lowered to reduce the risk of hypoglycaemia (low blood sugar levels).
F’ tali każijiet, id- doża tas- sulphonylurea tista ’ titbaxxa sabiex tnaqqas ir - riskju tal- ipogliċimija (livelli baxxi ta ’ zokkor fid- demm).
TESAVEL is not recommended for use in patients who have moderate or severe problems with their kidneys, or in patients aged less than 18 years.
TESAVEL m' għandhiex tittieħed minn pazjenti li għandhom problemi moderati għal serji bil- kliewi tagħhom, jew f' pazjenti li għandhom inqas minn 18- il sena.
How does TESAVEL work?
Kif jaħdem TESAVEL?
The active substance in TESAVEL, sitagliptin, is a dipeptidyl peptidase 4 (DPP-4) inhibitor.
Is- sustanza attiva f' TESAVEL, sitagliptin, hija inibitur tat- tip dipeptidyl peptidase 4 (DPP4).
By increasing levels of incretin hormones in the blood, sitagliptin stimulates the pancreas to produce more insulin when blood sugar levels are high.
Taħdem billi timblokka t- tkissir ta ’ l- ormoni ta ’ ‘ inkretin ’ fil- ġisem.
Sitagliptin does not work when the blood sugar is low.
Dawn l- ormoni jiġu rilaxxati wara ikla u jistimulaw il- frixa sabiex tipproduċi insulina.
Sitagliptin also reduces the amount of sugar made by the liver, by 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
Billi żżid il- livelli ta ’ ormoni ‘ incretin ’ fid- demm, sitagliptin tistimula l- frixa sabiex tipproduċi iktar insulina meta l- livell ta ’ 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
Reproduction is authorised provided the source is acknowledged increasing insulin levels and decreasing the levels of the hormone glucagon.
Sitagliptin ma taħdimx meta l- livell ta ’ glukożju fid- demm ikun baxx.
Together, these processes reduce blood glucose levels and help to control type 2 diabetes.
Flimkien, dawn il- proċessi jnaqqsu l- livelli ta ’ glukosju fid - demm u jgħinu biex jikkontrollaw id- dijabete ta ’ tip 2.
How has TESAVEL been studied?
Kif ġie studjat TESAVEL?
The effects of TESAVEL were first tested in experimental models before being studied in humans.
L- effetti ta ’ TESAVEL għall- ewwel ġew ittestjati f’ mudelli sperimentali qabel ma ġew studjati fuq il - bniedem.
TESAVEL 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.
TESAVEL ġiet studjata f’ ħames studji prinċipali li damu sa sena, u li involvew kważi 4, 000 pazjent b' dijabete tat- tip 2 li l- livelli ta 'zokkor fid- demm tagħhom ma kienux ikkontrollati b' mod adegwat.
Four of the studies compared TESAVEL 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).
Erba 'mill- istudji qabblu TESAVEL ma' plaċebo (trattament finta), jew meta tittieħed waħidha (żewġ studji li nvolvew 1, 262 pazjent), jew meta miżjuda ma 'metformin (f' 702 pazjenti) jew ma' thiazolidinedione pioglitazone (fi 353 pazjent).
The fifth study compared TESAVEL to glipizide (a sulphonylurea), as an add-on to metformin in 1,172 patients.
Il- ħames studju qabbel TESAVEL ma 'glipizide (mediċina oħra sulphonylurea), bħala żieda ma' metformin f' 1, 172 pazjent.
An additional study compared TESAVEL to placebo, when used as an add-on to glimepiride (another sulphonylurea), with or without metformin, in 441 patients.
Studju addizzjonali qabbel TESAVEL ma ’ placebo, meta miżjud ma ’ glimepiride (sulphonylurea), bi jew mingħajr metformin, 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 glycosylated haemoglobin (HbA1c), li tagħti indikazzjoni ta 'kemm il- glucosju fid - demm huwa kkontrollat.
What benefit has TESAVEL shown during the studies?
Liema benefiċċju wera TESAVEL waqt l- istudji li ġew mwettqa?
TESAVEL was more effective than placebo when it was taken alone or in combination with other antidiabetes medicines.
TESAVEL kienet aktar effettiva minn plaċebo meta ttieħdet waħidha jew flimkien ma 'mediċina oħra kontra d- dijabete.
In combination with metformin, a daily dose of 100 mg TESAVEL 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.
B’ kumbinazzjoni ma ’ metformin, doża ta ’ kuljum ta ’ 100mg TESAVEL naqqset l- HbA1c b’ 0. 70% (minn 7. 96 għal 7. 26%) wara 24 ġimgħa, mqabbla ma ’ waqa ’ ta ’ 0. 08% f’ pazjenti li jżidu l- placebo.
In combination with pioglitazone, 100 mg TESAVEL reduced HbA1c levels by 0.88% after 24 weeks, compared to 0.18% in the patients adding placebo.
Flimkien ma ’ ma ’ pioglitazone, 100 mg TESAVEL naqqas il- livelli Hba1c b’ 0. 88% wara 24 ġimgħa, mqabbla ma ’ waqa ’ ta ’ 0. 18% f’ pazjenti li jżidu l- placebo.
In the study comparing TESAVEL and glipizide as an add-on to metformin, glipizide was initially more effective than TESAVEL in reducing HbA1c levels.
Fl- istudju li jqabbel TESAVEL u glipizide miżjud ma 'metformin, fil- bidu, glipizide kien aktar effettiv minn TESAVEL fit- tnaqqis tal- livelli ta' HbA1c.
However, in patients continuing to take TESAVEL or glipizide, the two medicines had similar levels of effectiveness after a year of treatment.
Minkejja dan, f’ pazjenti li jkomplu jieħdu TESAVEL jew glipizide, iż- żewġ mediċini kellhom l- istess livelli ta ’ effettività wara sena ta ’ trattament.
TESAVEL was also more effective than placebo when it was added to glimepiride (with and without metformin).
TESAVEL kienet aktar effettiva mill - placebo meta ġiet miżjuda mal- glimepiride (b’ metformin jew mingħajru).
This reduced HbA1c levels after 24 weeks by 0.30% in patients receiving TESAVEL and glimepiride, and by 0.60% in the patients who were also taking metformin in addition to TESAVEL and glimepiride.
Dawn naqqas il- livelli ta ’ Hba1C wara 24 ġimgħa b’ 0. 30% f’ pazjenti li jirċievu TESAVEL u glimepiride, u b’ 0. 60% f’ pazjenti li kienu qed jieħdu wkoll meformin flimkien ma ’ TESAVEL u glimepiride.
What is the risk associated with TESAVEL?
X’ inhu r- riskju assoċjat ma ’ TESAVEL?
The most common side effect when taking TESAVEL with other medicines is hypoglycaemia.
L- aktar effetti sekondarji komuni fit- teħid ta ’ TESAVEL flimikien ma ’ mediċini oħrajn hija l - ipogliċimija.
This is seen in more than 1 patient in 10 when TESAVEL is taken with a sulphonylurea (with or without metformin) and in between 1 and 10 patients in 100 when TESAVEL is taken with a PPAR gamma agonist.
Dan jidher f’ iktar minn pazjent minn kull 10 meta TESAVEL tiġi meħuda flimkien ma ’ sulphonylurea (bi jew mingħajr metformin) u f’ bejn pazjent u 10 minn 100 meta TESAVEL tiġi meħuda ma ’ PPAR gamma agonist.
When TESAVEL is taken with metformin only, the most common side effect (seen in between 1 and 10 patients in 100) is nausea (feeling sick).
Meta TESAVEL tiġi meħuda ma ’ metformin biss, l- aktar effett sekondarju komuni (muri f’ bejn pazjent u 10 minn 100) hija n- nawżja (dardir).
For the full list of all side effects reported with TESAVEL, see the Package Leaflet.
Għal- lista sħiħa ta ’ l - effetti sekondarji kollha rrappurtata b’ TESAVEL, ara l- Fuljett ta ’ Tagħrif.
TESAVEL should not be used in people who may be hypersensitive (allergic) to sitagliptin or any of the other ingredients.
TESAVEL m' għandhiex tintuża minn persuni li jkunu ipersensittivi (allerġiċi) għas- sitagliptin jew għal xi sustanza oħra tiegħu.
Why has TESAVEL been approved?
Għaliex ġie approvata TESAVEL?
The Committee for Medicinal Products for Human Use (CHMP) decided that TESAVEL’ 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 ’ TESAVEL jisbqu r- riskji tagħha għall- kura ta 'pazjenti b' dijabete mellitus tat- tip 2 sabiex ittejjeb il - kontroll glikemiku Flimkien ma ’ ma' metformin u/ jew sulphonylurea, jew gamma agonista PPAR, meta dieta u eżerċizzju flimkien ma 'mediċina waħda ma jipprovdux kontroll glikemiku adegwat.
The Committee recommended that TESAVEL be given marketing authorisation.
Il - Kumitat irrakkomanda li TESAVEL jingħata awtorizzazzjoni għat- tqegħid fis- suq.
Other information about TESAVEL:
Tagħrif ieħor dwar TESAVEL:
The European Commission granted a marketing authorisation valid throughout the European Union for TESAVEL to Merck Sharp & Dohme Ltd. on 10 January 2008.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fis- suq valida fl- Unjoni Ewropea kollha għal TESAVEL lil Merck Sharp & Dohme Ltd fit- 10 ta 'Jannar 2008.
The full EPAR for TESAVEL can be found here.
L- EPAR sħiħ għal TESAVEL jista ’ jinstab hawnhekk
This summary was last updated in 12-2007.
Dan is- sommarju ġie aġġornat l- aħħar f' 12- 2007.
EMEA Procedure number
Numru tal- proċedura ta ’ l - EMEA
Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet
Pillola miksija b’ rita
Oral use Oral use Oral use Oral use Oral use Oral use
Użu orali
Blister (PVC/ PE/ PVDC/ alu) Blister (PVC/ PE/ PVDC/ alu) Blister (PVC/ PE/ PVDC/ alu) Blister (PVC/ PE/ PVDC/ alu) Blister (PVC/ PE/ PVDC/ alu) Perforated unit dose blister (PVC/ PE/ PVDC/ alu)
Folja (PVC/ PE/ PVDC/ alu)
100 mg 100 mg 100 mg 100 mg 100 mg 100 mg
Pillola miksija b’ rita
Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet
Użu orali
Oral use Oral use Oral use Oral use Oral use Oral use
Folja (PVC/ PE/ PVDC/ alu)
Blister (PVC/ PE/ PVDC/ alu) Blister (PVC/ PE/ PVDC/ alu) Blister (PVC/ PE/ PVDC/ alu) Blister (PVC/ PE/ PVDC/ alu) Blister (PVC/ PE/ PVDC/ alu) Perforated unit dose blister (PVC/ PE/ PVDC/ alu)
Perforated unit dose Folja (PVC/ PE/ PVDC/ alu)
TESAVEL 25 mg film-coated tablets
TESAVEL 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 g al 25 mg ta ’ sitagliptin.
For a full list of excipients, see section 6.1.
G al- lista kompleta ta’ sustanzi mhux attivi, ara sezzjoni 6. 1.
Round, pink film-coated tablet with “ 221” on one side.
Pillola miksija b’ rita tonda u ro a bi “ 221 ” fuq na a wa da.
For patients with type 2 diabetes mellitus, TESAVEL is indicated:
G al pazjenti bid- dijabete mellitus tat- tip 2, TESAVEL 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 gli emiku flimkien ma ’ metformin meta d- dieta u l- e er izzju, flimkien ma ’ metformin wa edhom ma jipprovdux kontroll gli emiku 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 gli emiku flimkien ma ’ sulphonylurea meta d- dieta u l- e er izzju flimkien ma ’ do a massima tollerata ta ’ sulphonylurea wa edhom ma jipprovdux kontroll gli emiku adegwat u meta metformin ma jkunx adegwat min abba 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 gli emiku flimkien ma ’ sulphonylurea u metformin meta d- dieta u l - e er izzju flimkien ma ’ terapija b’ dawn i - ew sustanzi ma jipprovdux kontroll gli emiku adegwat.
For patients with type 2 diabetes mellitus in whom use of a PPARγ agonist (i. e. a thiazolidinedione) is appropriate, TESAVEL is indicated:
G al pazjenti bid- dijabete mellitus tat- tip 2 li g alihom l- u u ta ’ agonist ta ’ PPARγ (i. e. thiazolidinedione) huwa adegwat, TESAVEL 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 ta ’ PPARγ meta d- dieta u l- e er izzju, flimkien ma ’ agonist ta ’ PPARγ ma jipprovdux kontroll gli emiku adegwat.
The dose of TESAVEL is 100 mg once daily.
Id- do a ta ’ TESAVEL hija 100 mg darba kuljum.
The dosage of metformin or PPARγ agonist should be maintained, and sitagliptin administered concomitantly.
ta ’ metformin jew l- agonist ta ’ PPARγ
When TESAVEL is used in combination with a sulphonylurea, a lower dose of the sulphonylurea may be considered to reduce the risk of hypoglycaemia.
Meta TESAVEL jintu a flimkien ma ’ sulphonylurea, tista ’ titqies do a i g ar ta ’ sulphonylurea biex jitnaqqas ir- riskju ta ’ ipogli emija.
If a dose of TESAVEL is missed, it should be taken as soon as the patient remembers.
Jekk tinqabe do a ta ’ TESAVEL, g andha tittie ed malli jiftakar il- pazjent.
A double dose should not be taken on the same day.
M’ g andhiex tittie ed do a doppja fl- istess urnata.
TESAVEL can be taken with or without food.
TESAVEL tista ’ tittie ed ma ’ l- ikel jew ming ajr ikel.
2 Patients with renal insufficiency For patients with mild renal insufficiency (creatinine clearance [CrCl] ≥ 50 ml/ min), no dosage adjustment for TESAVEL is required.
2 Pazjenti b’ insuffi jenza renali ija tal- krejatinina [CrCl] ≥50 ml/ min,, m’ hemmx G al pazjenti b’ insuffi jenza renali afifa (tne b onn bidla fid- do a ta ’ TESAVEL.
Clinical study experience with TESAVEL in patients with moderate or severe renal insufficiency is limited.
Esperjenza minn studji klini i b’ TESAVEL f’ pazjenti b’ insuffi jenza renali moderata jew qawwija hi limitata.
Therefore, use of TESAVEL is not recommended in this patient population (see section 5.2).
G alhekk, l- u u ta ’ TESAVEL mhux rakkomandat f 'il- popolazzjoni ta' sezzjoni 5. 2).
Patients with hepatic insufficiency No dosage adjustment is necessary for patients with mild to moderate hepatic insufficiency.
Pazjenti b’ insuffi jenza epatika
TESAVEL has not been studied in patients with severe hepatic insufficiency.
M’ hemmx g alfejn bidla fid- do a g al pazjenti li g andhom insuffi jenza epatika afifa jew moderata TESAVEL ma iex studjat f’ pazjenti b’ insuffi jenza epatika qawwija.
Elderly No dosage adjustment is necessary based on age.
Anzjani M’ hemmex g alfejn bidla fid- do a min abba l- età.
Limited safety data is available in patients ≥ 75 years of age and care should be exercised.
Hemm tag rif limitat dwar sigurtà f’ pazjenti ta ’ 75 sena u g andha tigi ezercitata attenzjoni
Paediatric population TESAVEL 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 TESAVEL mhux rakkomandat g al u u fit- tfal ta t it- 18- il sena min abba nuqqas ta ’ informazzjoni dwar is- sigurtà u l- effika ja.
Hypersensitivity to the active substance or to any of the excipients (see section 4.4 and 4.8).
Sensittività e essiva g as- sustanza attiva jew g al xi sustanzi mhux attivi (ara sezzjonijiet 4. 4 u 4. 8).
General TESAVEL should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis.
enerali TESAVEL m’ g andux jintu a f ’ pazjenti bid- dijabete ta ’ tip 1 jew g all- kura ta ’ ketoa ido i dijabetika.
Hypoglycaemia when used in combination with other anti-hyperglycaemic agents In clinical trials of TESAVEL 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.
Ipogli emija meta jintu a flimkien ma ’ sustanzi anti- iperglimi i o rajn Fi provi klini i ta ’ TESAVEL b ala terapija wa edha u f’ terapija flimkien ma ’ sustanzi li mhumiex mag rufin li jikkaw aw ipogli emija (i. e. metformin jew pioglitazone), ir- rati ta ’ ipogli emija li ew irrappurti b’ sitagliptin kienu simili g ar- rati f’ pazjenti li kienu qed jie du pla ebo.
When sitagliptin was added to a sulphonylurea, the incidence of hypoglycaemia was increased over that of placebo (see section 4.8).
Meta sitagliptin ie mi jud ma ’ sulphonylurea, l- in idenza ta ’ ipogli emija kibret meta mqabbla ma ’ pla ebo (ara sezzjoni 4. 8).
Therefore, to reduce the risk of hypoglycaemia, a lower dose of sulphonylurea may be considered (see section 4.2).
G alhekk, biex jitnaqqas ir- riskju ta ’ ipogli emija, g andha ti i kkunsidrata do a i g ar ta ’ sulphonylurea (ara sezzjoni 4. 2).
The use of sitagliptin in combination with insulin has not been adequately studied.
L- u u ta ’ sitagliptin flimkien ma ’ insulina ma iex studjat bi ejjed.
Renal insufficiency As the experience is limited, patients with moderate to severe renal insufficiency should not be treated with TESAVEL (see section 5.2).
Insuffi jenza renali Min abba li l- esperjenza hi limitata, pazjenti b’ insuffi jenza renali moderata jew severa m’ g andhomx ji u kkurati b’ TESAVEL (ara sezzjoni 5. 2).
Hypersensitivity Reactions Postmarketing reports of serious hypersensitivity reactions in patients treated with TESAVEL have been reported.
Reazzjonijiet ta ’ sensittività e essiva ew irrapportati rapporti ta ’ wara t- tqeg id fis- suq ta ’ reazzjonijiet ta ’ sensittività e essiva serji f’ pazjenti ittrattati b ’ TESAVEL.
These reactions include anaphylaxis, angioedema, and exfoliative skin conditions including Stevens-Johnson syndrome.
Dawn ir- reazzjonijiet jinkludu anafilassi, an joedema, u kundizzjonijiet ta ’ ilda li titqaxxar inklu is- sindromu ta ’ Stevens- Johnson.
Onset of these reactions occurred within the first 3 months after initiation of treatment with TESAVEL, with some reports occurring after the first dose.
Il- bidu ta ’ dawn ir - reazzjonijiet se fi mien l- ewwel 3 xhur wara l- bidu tat- trattament b’ TESAVEL, b’ xi rapporti jse u wara l- ewwel do a.
If a hypersensitivity reaction is suspected, discontinue TESAVEL, assess for other potential causes for the event, and institute alternative treatment for diabetes (see section 4.8).
Jekk ikun hemm suspett ta ’ reazzjoni ta ’ sensittività e essiva, waqqaf TESAVEL, ivvaluta kaw i potenzjali o ra g all- episodju, u ibda trattament alternattiv g ad- dijabete (ara sezzjoni 4. 8).
4.5 Interaction with other medicinal products and other forms of interaction
3 4. 5 Prodotti medi inali o ra li ma jaqblux ma ’ dan il- prodott u affarjiet o ra li jistg u jibdlu l- effett farma ewtiku tal- prodott
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 ’ medi ini o ra fuq sitagliptin It- tag rif kliniku ta ’ hawn ta t jag ti x’ jifhem li r- riskju ta ’ interazzjonijiet b’ rilevanza klinika ma ’ prodotti medi inali mog tija flimkien huwa baxx.
Co-administration of multiple twice-daily doses of 1000 mg metformin with 50 mg sitagliptin did not meaningfully alter the pharmacokinetics of sitagliptin in patients with type 2 diabetes.
L- g oti ta ’ do i multipli ta ’ darbtejn kuljum ta ’ 1000 mg ta ’ metformin flimkien ma ’ 50 mg ta ’ sitagliptin ma biddilx b’ mod sinifikanti l- farmakokinetika ta ’ sitagliptin f’ pazjenti b’ dijabete tat- tip 2.
A study was conducted to assess the effect of cyclosporine, a potent inhibitor of p-glycoprotein, on the pharmacokinetics of sitagliptin.
Sar studju biex iqis l- effett ta ’ cyclosporine, inibitur qawwi ta ’ p- glycoprotein, fuq il - farmakokinetika ta ’ sitagliptin.
Coadministration of a single 100 mg oral dose of sitagliptin and a single 600 mg oral dose of cyclosporine increased the AUC and Cmax of sitagliptin by approximately 29% and 68%, respectively.
L- g oti flimkien ta ’ do a wa da orali ta ’ 100 mg ta ’ sitagliptin u do a wa da orali ta ’ 600 mg ta ’ cyclosporine kabbar il - AUC u Cmax ta ’ sitagliptin bejn wie ed u ie or b’ 29% u 68%, rispettivament.
These changes in sitagliptin pharmacokinetics were not considered to be clinically meaningful.
Dawn il- bidliet fil- farmakokinetika ta ’ cyclosporine ma tqisux li g andhom relevanza klinika.
The renal clearance of sitagliptin was not meaningfully altered.
It- tne ija renali ta ’ sitagliptin ma tbiddlitx b’ mod sinifikanti.
Therefore, meaningful interactions would not be expected with other p-glycoprotein inhibitors.
G alhekk, mhux mistenni li jkun hemm interazzjonijiet sinifikanti ma ’ inibituri o ra ta ’ p- glycoprotein.
In vitro studies indicated that the primary enzyme responsible for the limited metabolism of sitagliptin is CYP3A4, with contribution from CYP2C8.
Studji in vitro indikaw li l- en ima prin ipali responsabbli g all- metaboli mu limitat ta ’ sitagliptin hija CYP3A4, b’ kontribuzzjoni minn CYP2C8.
In patients with normal renal function, metabolism, including via CYP3A4, plays only a small role in the clearance of sitagliptin.
F’ pazjenti b’ funzjoni renali normali, il- metaboli mu, inklu permezz ta ’ CYP3A4, g andu biss sehem g ir fit- tne ija ta ’ sitagliptin.
Metabolism may play a more significant role in the elimination of sitagliptin in the setting of severe renal insufficiency or ESRD.
Il- metaboli mu jista ’ jkollu sehem iktar sinifikanti fl- eliminazzjoni ta ’ sitagliptin fil- ka ta ’ insuffi jenza renali qawwija jew ESRD.
For this reason, it is possible that potent CYP3A4 inhibitors (i. e. ketoconazole, itraconazole, ritonavir, clarithromycin) could alter the phamacokinetics of sitagliptin in patients with severe renal insufficiency or ESRD.
G al din ir- ra uni, jista ’ jkun li inibituri qawwija ta ’ CYP3A4 (i. e. ketoconazole, itraconazole, ritonavir, clarithromycin) jistg u ibiddlu l- karatteristi i farmakokineti i ta ’ sitagliptin f’ pazjenti b’ insuffi jenza renali qawwija jew ESRD.
The effects of potent CYP3A4 inhibitors in the setting of renal insufficiency has not been assessed in a clinical study.
L- effetti ta ’ inibituri qawwija ta ’ CYP3A4 fil - ka ta ’ insuffi jenza renali ma tqisitx fi studju kliniku.
In vitro transport studies showed that sitagliptin is a substrate for p-glycoprotein and OAT3.
Studji ta ’ trasport in vitro wrew li sitagliptin huwa substrat g al p- glycoprotein u OAT3.
OAT3 mediated transport of sitagliptin was inhibited in vitro by probenecid, although the risk of clinically meaningful interactions is considered to be low.
Sitagliptin li t- trasport tieg u kien medjat permezz ta ’ OAT3 kien inibit in vitro b’ probenecid, g alkemm ir- riskju ta ’ interazzjonijiet klinikament rilevanti huwa meqjus li hu baxx.
Concomitant administration of OAT3 inhibitors has not been evaluated in vivo.
Ma ietx evalwata in vivo l- g oti fl - istess in ta ’ inibituri ta ’ OAT3.
Effects of sitagliptin on other medicinal products In vitro data suggest that sitagliptin does not inhibit nor induce CYP450 isoenzymes.
Effetti ta ’ sitagliptin fuq prodotti medi inali o ra Tag rif in vitro jag ti x’ jifhem li sitagliptin la jinibixxi u l- anqas jindu i l- isoen imi 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 klini i, sitagliptin ma biddilx b’ mod sinifikanti l- farmakokinetika ta ’ metformin, glyburide, simvastatin, rosiglitazone, warfarin, jew kontra ettivi orali, u dan ipprovda evidenza in vivo g al tendenza baxxa ta ’ interazzjonijiet ma ’ substrati ta ’ CYP3A4, CYP2C8, CYP2C9, u trasportatur organiku katajoniku (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- kon entrazzjonijiet ta ’ digoxin fil- pla ma, ujista ’ jkun inibitur afif ta ’ p- glycoprotein in vivo.
Sitagliptin had a small effect on plasma digoxin concentrations.
Sitagliptin kellu effett g ir fuq kon entrazzjonijiet ta ’ digoxin fil- pla ma.
Following administration of 0.25 mg digoxin concomitantly with 100 mg of TESAVEL 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 ing ata flimkien ma ’ 100 mg ta ’ TESAVEL kuljum g al 10 ijiem, l- AUC ta ’ digoxin fil - pla ma kibret b’ medja ta ’ 11%, u Cmax fil- pla ma b’ medja ta ’ 18%.
However, patients at risk of digoxin toxicity should be monitored for this when sitagliptin and digoxin are administered concomitantly.
Mhux rakkomandat li tinbidel id - do a ta ’ digoxin Madankollu, pazjenti li g andhom riskju ta ’ tossi ità b’ digoxin g andhom jit allew ta t sorveljanza g al dan meta sitagliptin u digoxin jing ataw flimkien.
4.6 Pregnancy and lactation
4 4. 6 Tqala u Treddig
Pregnancy There are no adequate data from the use of TESAVEL in pregnant women.
Tqala Mhemmx bi ejjed informazzjoni dwar l- u u ta ’ TESAVEL minn nisa tqal.
Studies in animals have shown reproductive toxicity at high doses (see section 5.3).
Studji fuq l- annimali urew tossi ità fis- sistema riproduttiva f’ dozi g oljin (ara sezzjoni 5. 3).
The potential risk for humans is unknown.
Il- potenzjal ta ’ riskju fil - bnedmin mhux mag ruf.
Due to lack of human data, TESAVEL should not be used during pregnancy.
Min abba n- nuqqas ta ’ informazzjoni dwar l- u u fil- bnedem, TESAVEL m’ g andux jintu a waqt it- tqala.
Lactation It is unknown whether sitagliptin is excreted in human breast milk.
Treddig Mhux nag ruf jekk sitagliptin jitne iex mal - alib tas- sider fil- bniedem.
Animal studies have shown excretion of sitagliptin in breast milk.
Studji fl- annimaliurew li sitagliptin jitne a mal - alib tas- sider.
TESAVEL should not be used during breast-feeding.
TESAVEL m’ g andux jintu a waqt treddigh ta ’ trabi.
However, when driving or operating machines, it should be taken into account that dizziness and somnolence have been reported.
Madankollu, meta ssuq jew t addem magni, jrid jigi ikkunsidrat li sturdament u ng as gew irrappurtati.
In 9 large clinical trials of up to 2 years in duration, over 2700 patients have received treatment with TESAVEL 100 mg per day alone or in combination with metformin, a sulphonylurea (with or without metformin) or a PPARγ agent.
F’ 9 provi klini i kbar li damu sa sentejn, iktar minn 2700 pazjent ir ieva trattament b’ 100 mg kuljum ta ’ TESAVEL wa du jew flimkien ma ’ metformin, sulphonylurea (b’ metformin jew ming ajru) jew sustanza ta ’ PPARγ.
In these trials, the rate of discontinuation due to adverse experiences considered drug-related was 0.8% with 100 mg per day and 1.5% with other treatments.
F’ dawn il- provi, ir- rata ta ’ dawk li waqfu jie du l- medi ina min abba esperjenzi avversi kkunsidrati relatati mal- medi ina kienet 0. 8% b’ 100 mg kuljum u 1. 5% ma ’ trattamenti o ra.
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 adu sitagliptin ma kellhomx iktar reazzjonijiet avversi kkunsidrati relatati mal- medi ina (> 0. 2% u differenza ta ’ > pazjent 1) meta mqabbla ma ’ pazjenti li adu kura ta ’ kontroll.
Adverse reactions considered as drug-related reported in patients treated with sitagliptin occurring in excess (> 0.2% and difference > 1 patient) of that in patients treated with placebo are listed below (Table 1) by system organ class and frequency.
Reazzjonijiet avversi meqjusin b ala relatati mal- medi ina rrapportati f’ pazjenti ttrattati b’ sitagliptin li se ew b’ mod aktar frekwenti (> 0. 2% u differenza > pazjent 1) milli f’ pazjenti ttrattati bi pla ebo huma elenkati hawn ta t (Tabella 1) skond is- sistema tal- klassifika ta ’ l- organi u l- frekwenza.
Frequencies are defined as: very common (≥ 1/ 10); common (≥ 1/ 100, < 1/ 10); uncommon (≥ 1/ 1000, < 1/ 100); rare (≥ 1/ 10000, < 1/ 1000); and very rare (< 1/ 10000).
Il - frekwenzi huma definiti kif ej: komuni afna (1/ 10); komuni (1/ 100, < 1/ 10); mhux komuni (1/ 1000, < 1/ 100); rari (1/ 10000, < 1/ 1000); u rari afna (< 1/ 10000).
Table 1.
5 Tabella 1.
The frequency of adverse reactions identified from placebo-controlled clinical studies
Il- frekwenza tar- reazzjonijiet avversi identifikati minn studji klini i kkontrollati bil - pla ebo
Adverse Reaction
Reazzjoni avversa
Frequency of adverse reaction by treatment regimen
Frekwenza tar- reazzjoni avversa skond ir- re imen tat- trattament
Sitagliptin with Sitagliptin with Sitagliptin with 1 2
Sitagliptin ma ’ Sitagliptin ma ’ Sitagliptin ma ’ Metformin1 Sulfonylurea2 Metformin u Sulfonylurea3
Sitagliptin with
Sitagliptin ma ’ sustanza ta ’ γ PPARγ (pioglitazone) 4
Metabolism and nutrition disorders
Disturbi fil - metaboli mu u n - nutrizzjoni
hypoglycaemia*
ipogli emija *
Very common Common
Komuni afna Komuni afna
Gastrointestinal disorders
Disturbi fis - sistema nervu a ng as Mhux komuni
diarrhea nausea flatulence constipation upper abdominal pain
Disturbi gastrointestinali dijarrea dardir gass stitikezza u ig fil- parti ta ’ fuq ta ’ l- addome
General disorders peripheral oedema
Disturbi enerali
In clinical trials of TESAVEL 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 * Fi provi klini i ta ’ TESAVEL b ala monoterapija u sitagliptin b ala parti minn terapija kkombinata ma ’ metformin jew pioglitazone, rati ta ’ ipogli emija rrapportati b’ sitagliptin kienu simili g al rati f’ pazjenti li kienu qed jie du pla ebo.
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 img a kkontrollat bi pla ebo ta ’ sitagliptin 100 mg darba kuljum flimkien ma ’ metformin, l- in idenza ta ’ reazzjonijiet avversi kkunsidrati relatati mal- medi ina f’ pazjenti ttrattati b’ sitagliptin/ metformin meta mqabbla ma ’ trattament bi pla ebo/ metformin kienet ta ’ 9. 3% u 10. 1%, rispettivament.
5 In an additional 1-year 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 sulphonylurea/ metformin was 14.5% and 30.3%, respectively.
Fi studju addizzjonali ta ’ sena fejn sitagliptin 100 mg darba kuljum ttie ed flimkien ma ’ metformin, l- in idenza ta ’ reazzjonijiet avversi kkunsidrati relatati mal- medi ina f’ pazjenti li adu sitagliptin/ metformin meta mqabbla ma ’ sulphonylurea/ metformin kienet ta ’ 14. 5% u 30. 3%, rispettivament.
In pooled studies of up to 1 year in duration comparing sitagliptin/ metformin to a sulphonylurea agent/ metformin, adverse reactions considered as drug-related reported in patients treated with sitagliptin 100 mg occurring in excess (> 0.2% and difference > 1 patient) of that in patients receiving the sulphonylurea agent are as follows: anorexia (Metabolism and nutritional disorders; frequency uncommon) and weight decreased (Investigations; frequency uncommon).
Fi studji mi bura flimkien li damu sa sena u li qabblu sitagliptin/ metformin ma ’ sustanza ta ’ sulphonylurea/ metformin, ir- reazzjonijiet avversi kunsidrati relatati mal- medi ina li dehru aktar (> 0. 2% u differenza ta ’ > pazjent 1) f’ pazjenti li adu sitagliptin 100 mg minn f’ pazjenti li adu sustanza ta ’ sulphonylurea, huma kif ejjin: anoressija (Disturbi fil- metaboli mu u n- nutrizzjoni; frekwenza mhux komuni) u tnaqqis fil- pi (Investigazzjonijiet; frekwenza mhux komuni)
2 In this 24-week study of sitagliptin 100 mg once daily in combination with glimepiride, the incidence of adverse reactions considered as drug-related in patients treated with sitagliptin/ glimepiride compared to treatment with placebo/ glimepiride was 11.3% and 6.6%, respectively.
6 2 F’ dan l- istudju ta ’ 24 img a ta ’ 100 mg ta ’ sitagliptin darba kuljum flimkien ma ’ glimepiride, l - in idenza ta ’ reazzjonijiet avversi li setg u jitqiesu li kienu relatati mal- medi ina f’ pazjenti kkurati b’ sitagliptin/ glimepiride meta mqabbla ma ’ kura bi pla ebo/ glimepiride kienet ta ’ 11. 3% u 6. 6% rispettivament.
3 In this 24-week study of sitagliptin 100 mg once daily in combination with glimepiride and metformin, the incidence of adverse reactions considered as drug-related in patients treated with sitagliptin in combination with glimepiride/ metformin compared to treatment with placebo in combination with glimepiride/ metformin was 18.1% and 7.1%, respectively.
3 F’ dan l- istudju ta ’ 24 img a ta ’ 100 mg ta ’ sitagliptin darba kuljum flimkien ma ’ glimepiride u metformin, l- in idenza ta ’ reazzjonijiet avversi li setg u jitqiesu li kienu relatati mal- medi ina f’ pazjenti kkurati b’ sitagliptin flimkien ma ’ glimepiride/ metformin meta mqabbla ma ’ kura bi pla ebo flimkien ma ’ glimepiride/ metformin kienet ta ’ 18. 1% u 7. 1% rispettivament.
4 In this 24-week study of the combination of sitagliptin 100 mg once daily and pioglitazone, the incidence of adverse reactions considered as drug-related in patients treated with sitagliptin/ pioglitazone compared to patients treated with placebo/ pioglitazone was 9.1% and 9.0%, respectively.
4 F’ dan l- istudju ta ’ 24 img a tal- kombinazzjoni ta ’ sitagliptin 100 mg darba kuljum u pioglitazone l- in idenza ta ’ reazzjonijiet avversi li setg u jitqiesu li kienu relatati mal- medi ina f’ pazjenti li adu sitagliptin/ pioglitazone meta mqabbla ma ’ pazjenti li adu pla ebo/ pioglitazone kienet ta ’ 9. 1% u 9. 0%, rispettivament.
In addition, in monotherapy studies of up to 24 weeks in duration of sitagliptin 100 mg once daily alone compared to placebo, adverse reactions considered as drug-related reported in patients treated with sitagliptin in excess (> 0.2% and difference > 1 patient) of that in patients receiving placebo are headache, hypoglycaemia, constipation, and dizziness.
Barra minn hekk, fi studji li damu sa 24 img a b’ terapija wa da ta ’ sitagliptin 100 mg darba kuljum wa du mqabbla ma ’ pla ebo, reazzjonijiet avversi kunsidrati relatati mal- medi ina li dehru aktar (> 0. 2% u differenza ta ’ > pazjent 1) f’ pazjenti li hadu TESAVEL minn f’ pazjenti li adu pla ebo, huma u ig ta ’ ras, ipogli emija, stitikezza, u sturdament
In addition to the drug-related adverse experiences described above, adverse experiences reported regardless of causal relationship to medication and occurring in at least 5% and more commonly in patients treated with TESAVEL included upper respiratory tract infection and nasopharyngitis.
Ma ’ dawn l- esperjenzi avversi kunsidrati relatati mal- medi ina deskritti hawn fuq esperjenzi avversi rrapportati bla referenza g ar- relazzjoni mal- medi ina u li raw mill- inqas f 'u b’ mod iktar komuni 5% f’ pazjenti fuq TESAVEL, kienu jinkludu, infezzjoni fil- parti ta ’ fuq tal- passa respiratorju u na ofarin ite.
Additional adverse experiences reported regardless of causal relationship to medication that occurred more frequently in patients treated with TESAVEL (not reaching the 5% level, but occurring with an incidence of > 0.5% higher with TESAVEL than that in the control group) included osteoarthritis and pain in extremity.
Esperjenzi avversi o ra avversi rraportati bla referenza g ar- relazzjoni mal- medi ina, li se ew b’ mod iktar frekwenti f’ pazjenti kkurati b’ TESAVEL (dawn ma la qux il- livell ta ’ 5%, imma se ew b’ in idenza ta ’ > 0. 5% og la b ’ TESAVEL milli fil- grupp ta ’ kontroll), kienu jinkludu ostjoartrite u u ig fl- estremitajiet.
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.
Fi studju ta ’ 24 img a ta ’ terapija kkombinata inizjali b’ sitagliptin u metformin mog tija darbtejn kuljum (sitagliptin/ metformin 50 mg/ 500 mg jew 50 mg/ 1000 mg), l- in idenza totali ta ’ reazzjonijiet avversi meqjusin relatati mal- medi ina f’ pazjenti ttratti b’ kombinazzjoni ta ’ sitagliptin u metformin meta mqabbla ma ’ pazjenti ttrattati bi pla ebo kienet ta ’ 14. 0% u 9. 7%, rispettivament.
The overall incidence of adverse reactions considered as drug-related in patients treated with the combination of sitagliptin and metformin was comparable to metformin alone (14.0% each) and greater than sitagliptin alone (6.7%), with the differences relative to sitagliptin alone primarily due to gastrointestinal adverse reactions.
L- in idenza totali ta ’ reazzjonijiet avversi meqjusin relatati mal- medi ina f’ pazjenti ttratti b’ kombinazzjoni ta ’ sitagliptin u metformin kienet komparabbli ma ’ dik ta ’ metformin wa du (14. 0% kull wie ed) u ikbar milli sitagliptin wa du (6. 7%), bid- differenzi fir- rigward ta ’ sitagliptin wa du, primarjament dovuti g al reazzjonijiet avversi gastrointestinali.
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 klini i, kienet osservata ieda g ira fil- g add ta - elloli bojod tad- demm( bejn wie ed u ie or differenza ta ’ 200 ellula/ microl f’ WBC meta mqabbel mal- pla ebo: linja ba i medja WBC bejn wie ed u ie or ta ’ 6600 ellula/ microl) min abba ieda fin- newtrofili.
This observation was seen in most but not all studies.
Din l- osservazjoni ma saritx fl- istudji kollha imma fil- bi a l- kbira tag homm.
This change in laboratory parameters is not considered to be clinically relevant.
Din il- bidla fil- parametri tal- laboratorju ma titqiesx klinikament rilevanti.
No clinically meaningful changes in vital signs or in ECG (including in QTc interval) were observed with TESAVEL treatment.
F’ kura b ’ TESAVEL ma ewx osservati bidliet b’ relevalnza klinika fis- sinjali vitali jew fl- ECG (inklu l- intervall QTc).
6 Post-marketing Experience:
Esperjenza ta ’ Wara t- Tqeg id fis- Suq:
During post-marketing experience the following additional side effects 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 l- esperjenza ta ’ wara t- tqeg id fis- suq ew irrappurtati l- effetti sekondarji o ra li ejjin (il - frekwenza mhix mag rufa): reazzjonijiet ipersensittivi nklu anafilassi, an joedema, raxx, urtikarja, u kundizzjonijiet ta ’ ilda li titqaxxar inklu is- sindromu ta ’ Stevens- Johnson (ara sezzjoni 4. 4).
During controlled clinical trials in healthy subjects, single doses of up to 800 mg sitagliptin were generally well tolerated.
Waqt provi klini i kkontrollati f’ persuni f’ sa ithom, do i wa danin ta ’ sitagliptin sa 800 mg eneralment kienu ttollerati sew.
Minimal increases in QTc, not considered to be clinically relevant, were observed in one study at a dose of 800 mg sitagliptin.
7 osservati fi studju wie ed b’ do a ta ’ 800 mg ta ’ sitagliptin.
There is no experience with doses above 800 mg in humans.
M’ hemmx esperjenza b’ do i ikbar minn 800 mg fil- bniedem..
In the event of an overdose, it is reasonable to employ the usual supportive measures, e. g., remove unabsorbed material from the gastrointestinal tract, employ clinical monitoring (including obtaining an electrocardiogram), and institute supportive therapy if required.
Fil- ka ta ’ do a e essiva, ikun ra onevoli li jintu aw il- mi uri ta ’ appo tas- soltu, ng idu a na jitne a materjal mhux assorbit mill- apparat gastro- intestinali, isir monitora kliniku (inklu elettrokardjogramma), u tinbeda terapija ta ’ appo g jekk hemm b onn.
Sitagliptin is modestly dialyzable.
Sitagliptin huwa kemmxejn dijali abbli.
In clinical studies, approximately 13.5% of the dose was removed over a 3- to 4-hour hemodialysis session.
Fi studji klini i, bejn wie ed u ie or 13. 5% tad- do a tne iet wara sessjoni ta ’ emodijalisi ta ’ bejn 3 u 4 sig at.
It is not known if sitagliptin is dialyzable by peritoneal dialysis.
Mhux mag ruf jekk sitagliptin hux dijali abbli permezz ta ’ dijalisi peritonali.
DPP-4 Inhibitor, ATC code:
Kategorija farmakoterapewtika: inibitur ta ’ DPP- 4, Kodi i ATC:
TESAVEL is a member of a class of oral anti-hyperglycaemic agents called dipeptidyl peptidase 4 (DPP-4) inhibitors.
TESAVEL huwa membru ta ’ klassi ta ’ sustanzi anti- ipergli emi i orali li jissej u inibituri ta ’ dipeptidyl peptidase 4 (DPP- 4).
The improvement in glycaemic control observed with this agent may be mediated by enhancing the levels of active incretin hormones.
It- titjib osservat fil- kontroll gli emiku b’ din is- sustanza jista ’ ji i medjat billi jitkattru l- livelli ta ’ l- ormoni attivi ta ’ incretin.
Incretin hormones, including glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP), are released by the intestine throughout the day, and levels are increased in response to a meal.
L- ormoni incretin, inklu il- peptide- 1 (GLP- 1) li qisu glucagon, u l- polypeptide insulinotropika li tiddependi mill- glucose (GIP), jintre ew mill- intestini matul il - urnata, u l- livelli jog lew wara ikla.
The incretins are part of an endogenous system involved in the physiologic regulation of glucose homeostasis.
L- incretini huma parti mis- sistema endogena li hija nvoluta fir- regolazzjoni fi jolo ika ta ’ l- omeosta i tal- glucose.
When blood glucose concentrations are normal or elevated, GLP-1 and GIP increase insulin synthesis and release from pancreatic beta cells by intracellular signaling pathways involving cyclic AMP.
Meta l - kon entrazzjonijiet ta ’ glucose fid- demm ikunu normali jew elevati, GLP- 1 and GIP ikattru s- sinte i u l - ru ta ’ l- insulina mi - elluli beta tal- frixa permezz ta ’ mog dijiet ta ’ senjalazzjoni intra ellulari li jinvolvu AMP ikliku.
Treatment with GLP-1 or with DPP-4 inhibitors in animal models of type 2 diabetes has been demonstrated to improve beta cell responsiveness to glucose and stimulate insulin biosynthesis and release.
F’ mudelli ta ’ annimali bid- dijabete ta ’ tip 2 il- kura b ’ GLP- 1 jew b’ inibituri ta ’ DPP- 4 uriet titjib fil - livell ta ’ respons ta - elluli beta g all- glucose, u stimulat l- bijosintesi u l - ru ta ’ l- insulina.
With higher insulin levels, tissue glucose uptake is enhanced.
F’ livelli og la ta ’ insulina, it- tessuti iktar jie du insulina.
In addition, GLP-1 lowers glucagon secretion from pancreatic alpha cells.
Ukoll, GLP- 1 inaqqas is - sekrezzjoni ta ’ glucagons mi - elluli alfa tal- frixa.
Decreased glucagon concentrations, along with higher insulin levels, lead to reduced hepatic glucose production, resulting in a decrease in blood glucose levels.
Kon entrazzjonijiet inqas ta ’ glucagon, flimkien ma ’ livelli og la ta ’ insulina, iwasslu g al tnaqqis fil- produzzjoni ta ’ glucose mill- fwied, li jwassal g al tnaqqis fil- livell ta ’ glucose fid- demm.
The effects of GLP-1 and GIP are glucose-dependent such that when blood glucose concentrations are low, stimulation of insulin release and suppression of glucagon secretion by GLP-1 are not observed.
L- effetti ta ’ GLP- 1 u GIP jiddependu mill- glucose b’ tali mod li meta l- kon entrazzjonijiet ta ’ glucose fid- demm huma baxxi, stimulazzjoni ta’ rilaxx ta ’ l - insulina u tra in tas- sekrezzjoni tal- glucagon mil- GLP- 1, ma humiex osservati.