natgillin/translations-raw huggingface dataset:
203 The following information is intended for medical or health care professional use only:
17 Naslednje informacije so namenjene samo zdravstvenemu osebju.
A volume up to 40 ml reconstituted solution should be withdrawn, according to the total prescribed dose and transferred into an empty 250 ml PVC infusion bag.
Odvzeti je treba do 40 ml rekonstituirane raztopine, glede na skupni predpisani odmerek, in jo prenesti v prazno 250- mililitrsko vrečko za infundiranje iz PVC.
The pump tubing should be attached to the bag, the tubing purged and then capped.
Cevi črpalke je treba priključiti na vrečko, ga izprazniti in nato pokriti.
Temodal 2.5 mg/ml must be administered by intravenous infusion only over a period of 90 minutes.
Zdravilo Temodal 2, 5 mg/ ml se sme intravensko infundirati samo v obdobju 90 minut.
In absence of compatibility studies this medicinal product must not be mixed with other medicinal products or infused simultaneously through the same intravenous line.
Zaradi pomanjkanja študij kompatibilnosti zdravila ne smemo mešati z drugimi zdravili, ali ga sočasno infundirati po isti intravenski liniji.
204
18
What is TESAVEL?
Kaj je zdravilo TESAVEL?
TESAVEL is a medicine containing the active substance sitagliptin.
TESAVEL je zdravilo, ki vsebuje zdravilno učinkovino sitagliptin.
This medicine is the same as Januvia, which is already authorised in the European Union (EU).
To zdravilo je enako zdravilu Januvia, ki je že odobreno v Evropski uniji (EU).
The company that makes Januvia has agreed that its scientific data can be used for TESAVEL.
Podjetje, ki proizvaja zdravilo Januvia, se strinja, da se lahko znanstveni podatki tega zdravila uporabijo za zdravilo TESAVEL.
What is TESAVEL used for?
Za kaj se zdravilo TESAVEL uporablja?
TESAVEL is used to treat patients with type 2 diabetes, to improve control of blood sugar levels.
Zdravilo TESAVEL se uporablja za zdravljenje bolnikov s sladkorno boleznijo tipa 2 za izboljšanje nadzora nad ravnjo sladkorja v krvi.
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.
Uporablja se skupaj z dieto in telesno vadbo, sočasno z enim ali več zdravili za sladkorno bolezen: • v kombinaciji z metforminom pri bolnikih, pri katerih samo z metforminom ne moremo doseči zadovoljivega nadzora bolezni, • v kombinaciji s sulfonilsečnino pri bolnikih, pri katerih samo s sulfonilsečnino ne moremo doseči zadovoljivega nadzora bolezni, metformin pa zanje ni primeren, • v kombinaciji z metforminom in sulfonilsečnino, kadar ti zdravili ne zagotavljata zadovoljivega nadzora bolnikove sladkorne bolezni, • v kombinaciji z agonistom PPAR gama, kot je tiazolidinedion, pri bolnikih, pri katerih samo z agonistom PPAR gama ne moremo doseči zadovoljivega nadzora bolezni.
How is TESAVEL used?
Kako se zdravilo TESAVEL uporablja?
TESAVEL is taken at a dose of 100 mg once a day, with or without food.
Zdravilo TESAVEL se jemlje v 100 mg odmerku enkrat dnevno s hrano ali brez nje.
There is no need to change the doses of the other medicines TESAVEL is taken with, except when TESAVEL is taken with a sulphonylurea.
Odmerkov zdravil, ki se jemljejo sočasno z zdravilom TESAVEL, ni treba spremeniti, razen ko se zdravilo TESAVEL jemlje skupaj s sulfonilsečnino.
In such cases, the dose of the sulphonylurea may be lowered to reduce the risk of hypoglycaemia (low blood sugar levels).
V takih primerih bo morda treba znižati odmerek sulfonilsečnine, da se zmanjša tveganje za pojav hipoglikemije (nizkih ravni krvnega sladkorja).
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.
Zdravilo TESAVEL ni priporočljivo za bolnike, ki imajo zmerne do hude težave z ledvicami, in bolnike, mlajše od 18 let.
How does TESAVEL work?
Kako zdravilo TESAVEL deluje?
The active substance in TESAVEL, sitagliptin, is a dipeptidyl peptidase 4 (DPP-4) inhibitor.
Sladkorna bolezen tipa 2 je bolezen, pri kateri trebušna slinavka ne proizvaja dovolj insulina za vzdrževanje primerne koncentracije glukoze (sladkorja) v krvi ali pri kateri telo ne more insulina učinkovito uporabljati.
It works by blocking the breakdown of ‘ incretin’ hormones in the body.
Zdravilna učinkovina zdravila TESAVEL je sitagliptin, ki je zaviralec
Reproduction is authorised provided the source is acknowledged increasing insulin levels and decreasing the levels of the hormone glucagon.
Deluje tako, da zavira razgradnjo hormonov inkretinov v telesu.
How has TESAVEL been studied?
Kako je bilo zdravilo TESAVEL raziskano?
The effects of TESAVEL were first tested in experimental models before being studied in humans.
Učinki zdravila TESAVEL so bili najprej preizkušeni na poskusnih modelih, nato pa so jih raziskali pri ljudeh.
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.
Zdravilo TESAVEL je bilo raziskano v petih glavnih študijah, ki so trajale do enega leta in so vključevale skoraj 4. 000 bolnikov s sladkorno boleznijo tipa 2, pri katerih ni bilo mogoče ustrezno nadzorovati njihovih ravni krvnega sladkorja.
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).
V štirih študijah so primerjali zdravilo TESAVEL s placebom (zdravilom brez zdravilne učinkovine), ki so ju bolniki jemali bodisi kot samostojni zdravili (dve študiji, ki sta vključevali 1. 262 bolnikov) ali pa kot dodatek k metforminu (pri 702 bolnikih) oziroma k agonistu PPAR gama, pioglitazonu (pri 353 bolnikih).
The fifth study compared TESAVEL to glipizide (a sulphonylurea), as an add-on to metformin in 1,172 patients.
V peti študiji so pri 1. 172 bolnikih primerjali zdravilo TESAVEL z glipizidom (vrsta sulfonilsečnine), ki so ju uporabili kot dodatek k metforminu.
An additional study compared TESAVEL to placebo, when used as an add-on to glimepiride (another sulphonylurea), with or without metformin, in 441 patients.
V dodatni študiji so pri 441 bolnikih zdravilo TESAVEL primerjali s placebom, ki so ju uporabili kot dodatek k glimepiridu (drugi vrsti sulfonilsečnine) z metforminom ali brez njega.
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.
Pri vseh študijah je bilo glavno merilo učinkovitosti sprememba količine snovi v krvi, imenovane glikozilirani hemoglobin (HbA1c), ki kaže, kako dobro je glukoza v krvi nadzorovana.
What benefit has TESAVEL shown during the studies?
Kakšne koristi je zdravilo TESAVEL izkazalo med raziskavami?
TESAVEL was more effective than placebo when it was taken alone or in combination with other antidiabetes medicines.
Zdravilo TESAVEL je bilo bolj učinkovito kot placebo, kadar so ga bolniki jemali kot samostojno zdravilo ali v kombinaciji z drugimi zdravili proti sladkorni bolezni.
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.
V kombinaciji z metforminom je 100 mg dnevni odmerek zdravila TESAVEL po 24 tednih znižal HbA1c za 0, 70% (s 7, 96 na 7, 26%) v primerjavi z znižanjem za 0, 08% pri bolnikih, ki so kot dodatno zdravilo prejemali 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.
V kombinaciji s pioglitazonom je 100 mg odmerek zdravila TESAVEL po 24 tednih znižal ravni HbA1c za 0, 88% v primerjavi z 0, 18% pri bolnikih, ki so kot dodatek prejemali 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.
V študiji, kjer so kot dodatka k zdravljenju z metforminom primerjali zdravilo TESAVEL in glipizid, je bil glipizid v začetni fazi pri nižanju ravni HbA1c učinkovitejši kot zdravilo TESAVEL.
However, in patients continuing to take TESAVEL or glipizide, the two medicines had similar levels of effectiveness after a year of treatment.
Vendar pa sta bili obe zdravili po enem letu zdravljenja pri bolnikih, ki so nadaljevali z jemanjem zdravil TESAVEL ali glipizid, podobno učinkoviti.
TESAVEL was also more effective than placebo when it was added to glimepiride (with and without metformin).
Zdravilo TESAVEL je bilo učinkovitejše od placeba tudi takrat, kadar so ga dodajali k glimepiridu (z metforminom ali brez njega).
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.
Po 24 tednih se je raven HbA1c pri bolnikih, ki so jemali zdravilo TESAVEL in glimepirid, znižala za 0, 30% v primerjavi z znižanjem za 0, 60% pri bolnikih, ki so poleg zdravila TESAVEL in glimepirida jemali tudi metformin.
What is the risk associated with TESAVEL?
Kakšna tveganja so povezana z zdravilom TESAVEL?
The most common side effect when taking TESAVEL with other medicines is hypoglycaemia.
Najpogostejši neželeni učinek jemanja zdravila TESAVEL skupaj z drugimi zdravili je hipoglikemija.
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.
Ta je bila opažena pri več kot 1 izmed 10 bolnikov, ki so jemali zdravilo TESAVEL skupaj s sulfonilsečnino (z metforminom ali brez njega), ter pri 1 do 10 bolnikih izmed 100, ki so jemali zdravilo TESAVEL skupaj z agonistom PPAR gama.
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).
Kadar se zdravilo TESAVEL kombinira samo z metforminom, je najpogostejši neželeni učinek (opažen pri 1 do 10 bolnikih izmed 100) navzeja (občutek slabosti).
For the full list of all side effects reported with TESAVEL, see the Package Leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila TESAVEL, glejte navodilo za uporabo.
TESAVEL should not be used in people who may be hypersensitive (allergic) to sitagliptin or any of the other ingredients.
Zdravila TESAVEL ne smejo uporabljati osebe, ki utegnejo biti preobčutljive za (alergične na) sitagliptin ali katerokoli drugo sestavino zdravila.
Why has TESAVEL been approved?
Zakaj je bilo zdravilo TESAVEL odobreno?
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.
Odbor za zdravila za uporabo v humani medicini (CHMP) meni, da so koristi zdravila TESAVEL večje od z njim povezanih tveganj pri zdravljenju bolnikov s sladkorno boleznijo tipa 2 in izboljševanju nadzora nad glikemijo v kombinaciji z metforminom in/ ali sulfonilsečnino ali agonistom PPAR gama, kadar dieta in telesna vadba ob hkratnem zdravljenju z drugimi zdravili ne privedeta do primernega nadzora nad glikemijo.
The Committee recommended that TESAVEL be given marketing authorisation.
Odbor je priporočil odobritev dovoljenja za promet z zdravilom TESAVEL.
Other information about TESAVEL:
Druge informacije o zdravilu TESAVEL:
The European Commission granted a marketing authorisation valid throughout the European Union for TESAVEL to Merck Sharp & Dohme Ltd. on 10 January 2008.
Evropska komisija je dovoljenje za promet z zdravilom TESAVEL, veljavno po vsej Evropski uniji, odobrila družbi Merck Sharp & Dohme Ltd dne 10. januarja 2008.
The full EPAR for TESAVEL can be found here.
Celotno Evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo TESAVEL je na voljo tukaj.
EMEA Procedure number
Številka postopka EMEA
Invented name
Izmišljeno ime TESAVEL
Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet
Filmsko obložene tablete
Oral use Oral use Oral use Oral use Oral use Oral use
Peroralna uporaba
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)
pretisni omot (PVC/ PE/ PVDC/ alu)
EMEA/ H/ C/ 910/ 07 EMEA/ H/ C/ 910/ 08 EMEA/ H/ C/ 910/ 09 EMEA/ H/ C/ 910/ 10 EMEA/ H/ C/ 910/ 11 EMEA/ H/ C/ 910/ 12
EMEA/ H/ C/ 910/ 03
TESAVEL TESAVEL TESAVEL TESAVEL TESAVEL TESAVEL
TESAVEL TESAVEL
50 mg 50 mg 50 mg 50 mg 50 mg 50 mg
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Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet
perforirani enoodmerni pretisni omot( PVC/ PE/ PVDC/ alu)
Oral use Oral use Oral use Oral use Oral use Oral use
Filmsko obložene tablete
For patients with type 2 diabetes mellitus, TESAVEL is indicated:
Pri bolnikih s sladkorno boleznijo tipa 2 je zdravilo TESAVEL indicirano:
• to improve glycaemic control in combination with metformin when diet and exercise plus metformin alone do not provide adequate glycaemic control.
• v kombinaciji z metforminom za izboljšanje urejenosti glikemije, e urejenost sladkorne bolezni z dieto in telesno vadbo ter zdravljenjem z metforminom samim ni zadostna.
• 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.
• v kombinaciji s sulfonilse nino za izboljšanje urejenosti glikemije, e urejenost sladkorne bolezni z dieto in telesno vadbo ter zdravljenjem z najve jim dovoljenim odmerkom sulfonilse nine same ni zadostna, zdravljenje z metforminom pa zaradi kontraindikacij ali intolerance ni primerno.
• 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.
• v kombinaciji s sulfonilse nino in metforminom za izboljšanje urejenosti glikemije, e urejenost sladkorne bolezni z dieto in telesno vadbo ter zdravljenjem s tema zdraviloma ni zadostna.
For patients with type 2 diabetes mellitus in whom use of a PPARγ agonist (i. e. a thiazolidinedione) is appropriate, TESAVEL is indicated:
Pri bolnikih s sladkorno boleznijo tipa 2, pri katerih je primerna uporaba agonista PPARγ (npr. tiazolidindiona), je zdravilo TESAVEL indicirano:
• in combination with the PPARγ agonist when diet and exercise plus the PPARγ agonist alone do not provide adequate glycaemic control.
• v kombinaciji z agonistom PPARγ, e urejenost sladkorne bolezni z dieto in telesno vadbo ter zdravljenjem z agonistom PPARγ samim ni zadostna.
The dose of TESAVEL is 100 mg once daily.
Odmerek zdravila TESAVEL je 100 mg enkrat na dan.
The dosage of metformin or PPARγ agonist should be maintained, and sitagliptin administered concomitantly.
Z zdravljenjem z metforminom ali agonistom PPARγ je treba nadaljevati, sitagliptin pa uporabljati so asno.
When TESAVEL is used in combination with a sulphonylurea, a lower dose of the sulphonylurea may be considered to reduce the risk of hypoglycaemia.
Pri uporabi zdravila TESAVEL v kombinaciji s sulfonilse nino je odmerek sulfonilse nine morda treba zmanjšati, da se tako zmanjša tveganje za pojav hipoglikemije.
If a dose of TESAVEL is missed, it should be taken as soon as the patient remembers.
e bolnik izpusti odmerek zdravila TESAVEL, ga mora vzeti takoj, ko se spomni.
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 Bolniki z ledvi no insuficienco Pri bolnikih z blago ledvi no insuficienco (kreatininski o istek [CrCl] ≥ 50 ml/ min) odmerka zdravila TESAVEL ni treba prilagajati.
Clinical study experience with TESAVEL in patients with moderate or severe renal insufficiency is limited.
Izkušnje iz klini nih študij z zdravilom TESAVEL so pri bolnikih z zmerno ali s hudo ledvi no insuficienco omejene.
Therefore, use of TESAVEL is not recommended in this patient population (see section 5.2).
Pri tej skupini bolnikov uporabe zdravila TESAVEL ne priporo amo (glejte poglavje 5. 2).
TESAVEL has not been studied in patients with severe hepatic insufficiency.
Pri bolnikih s hudo jetrno insuficienco uporaba zdravila TESAVEL ni raziskana.
Limited safety data is available in patients ≥ 75 years of age and care should be exercised.
75 let, so podatki o varnosti
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.
Zaradi pomanjkanja podatkov o varnosti in u inkovitosti uporabe zdravila TESAVEL pri otrocih, mlajših od 18 let, ne priporo amo.
Hypersensitivity to the active substance or to any of the excipients (see section 4.4 and 4.8).
Preob utljivost za zdravilno u inkovino ali katerokoli pomožno snov (glejte poglavji 4. 4 in 4. 8).
General TESAVEL should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis.
Splošno Zdravila TESAVEL se ne sme uporabljati pri bolnikih s sladkorno boleznijo tipa 1 ali za zdravljenje diabeti ne ketoacidoze.
When sitagliptin was added to a sulphonylurea, the incidence of hypoglycaemia was increased over that of placebo (see section 4.8).
Hipoglikemija pri zdravljenju v kombinaciji z ostalimi antihiperglikemiki V klini nih preskušanjih zdravila TESAVEL kot samostojnega zdravila in v kombinaciji z drugimi zdravili za katere ni znano, da povzro ijo hipoglikemijo (npr. metformin ali pioglitazon), so pri bolnikih, ki so jemali sitagliptin, poro ali o podobnih deležih hipoglikemije kot pri bolnikih, ki so jemali placebo. e so bolniki, ki so se že zdravili s sulfonilse nino, za eli jemati še sitagliptin, je bila pojavnost hipoglikemije ve ja od pojavnosti pri placebu (glejte poglavje 4. 8).
Therefore, to reduce the risk of hypoglycaemia, a lower dose of sulphonylurea may be considered (see section 4.2).
Zato je za zmanjšanje tveganja za pojav hipoglikemije odmerek sulfonilse nine morda treba zmanjšati (glejte poglavje 4. 2).
Renal insufficiency As the experience is limited, patients with moderate to severe renal insufficiency should not be treated with TESAVEL (see section 5.2).
Ledvi na insuficienca Zaradi nezadostnih izkušenj z zdravilom bolniki z zmerno ali s hudo ledvi no insuficienco zdravila TESAVEL ne smejo jemati (glejte poglavje 5. 2).
Hypersensitivity Reactions Postmarketing reports of serious hypersensitivity reactions in patients treated with TESAVEL have been reported.
Preob utljivostne reakcije V postmarketinških raziskavah so poro ali o resnih preob utljivostnih reakcijah pri bolnikih, ki so bili zdravljeni z zdravilom TESAVEL.
These reactions include anaphylaxis, angioedema, and exfoliative skin conditions including Stevens-Johnson syndrome.
Te reakcije vklju ujejo anafilaksijo, angiodem in luš enje kože, vklju no s Steven- Johnson- ovim sindromom.
Onset of these reactions occurred within the first 3 months after initiation of treatment with TESAVEL, with some reports occurring after the first dose.
Reakcije so nastopile v prvih 3 mesecih po pri etku zdravljenja z zdravilom TESAVEL, v nekaterih primerih pa že po prvem odmerku. e obstaja sum na preob utljivostno reakcijo, prenehajte zdravljenje z zdravilom TESAVEL in ocenite tudi ostale možne vzroke za nastali zaplet ter dolo ite drugo možnost za zdravljenje sladkorne bolezni (glejte poglavje 4. 8).
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).
3 4. 5 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij
4.5 Interaction with other medicinal products and other forms of interaction
U inki drugih zdravil na sitagliptin
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.
V nadaljevanju navedeni klini ni podatki kažejo, da je pri so asni uporabi drugih zdravil tveganje za pojav klini no pomembnih interakcij majhno.
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.
Pri bolnikih s sladkorno boleznijo tipa 2 se pri ve kratnem so asnem dajanju metformina v odmerku 1. 000 mg dvakrat na dan in sitagliptina v odmerku 50 mg farmakokinetika sitagliptina ni pomembneje spremenila.
A study was conducted to assess the effect of cyclosporine, a potent inhibitor of p-glycoprotein, on the pharmacokinetics of sitagliptin.
Izvedena je bila študija, ki je ovrednotila u inek ciklosporina, mo nega zaviralca p - glikoproteina, na farmakokinetiko sitagliptina.
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.
Pri so asnem dajanju sitagliptina v obliki enkratnega 100 mg peroralnega odmerka in ciklosporina v obliki enkratnega 600 mg peroralnega odmerka sta se vrednosti AUC in Cmax sitagliptina pove ali, in sicer AUC za približno 29%, Cmax pa za približno 68%.
These changes in sitagliptin pharmacokinetics were not considered to be clinically meaningful.
Te spremembe farmakokinetike sitagliptina niso veljale za klini no pomembne.
The renal clearance of sitagliptin was not meaningfully altered.
Ledvi ni o istek sitagliptina se ni pomembneje spremenil.
Therefore, meaningful interactions would not be expected with other p-glycoprotein inhibitors.
Pomembnejše interakcije z drugimi zaviralci p - glikoproteina torej niso pri akovane.
In patients with normal renal function, metabolism, including via CYP3A4, plays only a small role in the clearance of sitagliptin.
Pri bolnikih z normalnim delovanjem ledvic ima presnova, vklju no s CYP3A4, pri o istku sitagliptina majhno vlogo.
Metabolism may play a more significant role in the elimination of sitagliptin in the setting of severe renal insufficiency or ESRD.
Pri bolnikih s hudo ledvi no insuficienco ali boleznijo ledvic v kon nem stadiju (ESRD – end- stage renal disease) ima lahko presnova pri izlo anju sitagliptina pomembnejšo vlogo.
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.
Pri bolnikih s hudo ledvi no insuficienco ali ESRD lahko mo ni zaviralci CYP3A4 (npr. ketokonazol, itrakonazol, ritonavir, klaritromicin) spremenijo farmakokinetiko sitagliptina.
The effects of potent CYP3A4 inhibitors in the setting of renal insufficiency has not been assessed in a clinical study.
V klini ni študiji niso ovrednotili u inkov mo nih zaviralcev CYP3A4 v primeru ledvi ne insuficience.
OAT3 mediated transport of sitagliptin was inhibited in vitro by probenecid, although the risk of clinically meaningful interactions is considered to be low.
Probenecid je in vitro zaviral prenos sitagliptina s pomo jo OAT3, vendar pa je tveganje za pojav klini no pomembnih interakcij majhno.
Concomitant administration of OAT3 inhibitors has not been evaluated in vivo.
So asna uporaba zaviralcev OAT3 in vivo ni bila ovrednotena.