natgillin/translations-raw huggingface dataset:
Contraindications of concomitant use (see section 4.3) Daklinza is contraindicated in combination with medicinal products that strongly induce CYP3A4 and P-gp, e.g. phenytoin, carbamazepine, oxcarbazepine, phenobarbital, rifampicin, rifabutin, rifapentine, systemic dexamethasone, and the herbal product St John's wort (Hypericum perforatum), and thus may lead to lower exposure and loss of efficacy of Daklinza.
in P-gp, npr. fenitoin, karbamazepin, okskarbazepin, fenobarbital, rifampicin, rifabutin, rifapentin, sistemski deksametazon in zdravila rastlinskega izvora, ki vsebujejo šentjanževko (Hypericum perforatum), saj se pri sočasni uporabi lahko zmanjša izpostavljenost zdravilu Daklinza in izgubi njegova učinkovitost.
Expected due to CYP3A4 inhibition by the antibacterial:
Pričakovano zaradi zaviranja CYP3A4 z zdravili za zdravljenje glivičnih okužb:
HIV antiviral agents, refer to section 4.5.
Za priporočila za odmerjanje skupaj s protivirusnimi zdravili proti HIV glejte poglavje 4.5.
Expected due to CYP3A4 inhibition by the calcium channel blocker:
Pričakovano zaradi zaviranja CYP3A4 z zaviralcem kalcijevih kanalčkov: ↑ Daklatasvir
Follow guidelines above for haemoglobin
> 50 ml/min upoštevajte zgornje smernice za hemoglobin
Table 12: Treatment outcomes, daclatasvir in combination with sofosbuvir for 12 weeks, patients with HCV genotype 3 in Study ALLY-3
Tabela 12: Izidi zdravljenja v študiji ALLY-3, daklatasvir v kombinaciji s sofosbuvirjem 12 tednov, bolniki z genotipom 3 HCV Predhodno nezdravljeni N=101
No dose adjustment of Daklinza or maraviroc is required.
Odmerka zdravila Daklinza ali maraviroka ni treba prilagajati.
If you do miss a dose: and you notice within 20 hours of the time you usually take Daklinza, you must take the tablet as soon as possible.
in od običajnega časa, ko vzamete zdravilo Daklinza, še ni minilo več kot 20 ur, tableto vzemite takoj, ko je to mogoče, nato pa vzemite naslednji odmerek ob običajnem času.
Daclatasvir administered as a tablet was readily absorbed following multiple oral doses with peak plasma concentrations occurring between 1 and 2 hours.
Daklatasvir v obliki tablete se pri ponavljajočih se peroralnih odmerkih hitro absorbira.
Patients with HCV infection (across genotypes) at high risk of decompensation or death within 12 months if left untreated were treated under compassionate use programmes.
Bolnike z okužbo s HCV (kateri koli genotip) in visokim tveganjem za dekompenzacijo ali smrt v
In addition some medicines may affect the way Daklinza works.
Nekatera druga zdravila lahko vplivajo na delovanje zdravila Daklinza in spremenijo količino zdravila
Daklinza 60 mg film-coated tablets
Daklinza 60 mg filmsko obložene tablete
IMMUNOSUPPRESSANTS Cyclosporine 400 mg single dose (daclatasvir 60 mg once daily)
ZDRAVILA ZA ZAVIRANJE IMUNSKE ODZIVNOSTI Ciklosporin, enkratni 400-mg odmerek (daklatasvir 60 mg enkrat na dan)
On-treatment virologic failure
Virusni neodziv med zdravljenjem
AUC: 1.01 (0.95, 1.07) Cmax: 1.11 (1.02, 1.20)
↔ Etinilestradiol AUC: 1,01 (0,95; 1,07) Cmax: 1,11 (1,02; 1,20)
Tacrolimus 5 mg single dose (daclatasvir 60 mg once daily)
Takrolimus, enkratni 5-mg odmerek (daklatasvir 60 mg enkrat na dan)
Administration of Daklinza with verapamil may result in increased concentrations of daclatasvir.
Daklinza in verapamila se koncentracije daklatasvirja lahko povečajo.
daclatasvir + sofosbuvir N=13
daklatasvir + sofosbuvir N=13
↔ Darunavir AUC: 0.90 (0.73, 1.11) Cmax: 0.97 (0.80, 1.17) Cmin: 0.98 (0.67, 1.44)
AUC: 0,90 (0,73; 1,11) Cmax: 0,97 (0,80; 1,17) Cmin: 0,98 (0,67; 1,44)
Induction of CYP3A4 by efavirenz
Indukcija CYP3A4 z efavirenzem.
HCV Treatmentnaïve
Druga protivirusna zdravila za zdravljenje okužbe s HCV
Titanium dioxide (E171) Macrogol 400
- Filmska obloga: hipromeloza, titanov dioksid (E171), makrogol 400, indigotin (E132) in rumeni železov oksid (E172).
daclatasvir + sofosbuvir + ribavirin N=56
daklatasvir + sofosbuvir + ribavirin N=56
Coadministration with medicinal products that strongly induce cytochrome P450 3A4 (CYP3A4) and P-glycoprotein transporter (P-gp) and thus may lead to lower exposure and loss of efficacy of Daklinza.
Pri sočasni uporabi zdravil, ki so močni induktorji citokroma P450 3A4 (CYP3A4) in prenašalca
If you have any questions about your medicines, please ask your doctor or pharmacist.
Če imate o predpisanih zdravilih kakršno koli vprašanje, se posvetujte z zdravnikom ali farmacevtom.
daclatasvir + sofosbuvir + ribavirin N=20
daklatasvir + sofosbuvir + ribavirin N=20
Description of selected adverse reactions
Opis izbranih neželenih učinkov Srčne aritmije
What Daklinza looks like and contents of the pack Daklinza 30 mg: the film-coated tablet is green, biconvex, pentagonal shape with "BMS" debossed on one side and "213" on the other side.
Daklinza 30 mg: zelena, obojestransko izbočena, peterokotna filmsko obložena tableta z vtisnjeno oznako “BMS” na eni in “213” na drugi strani.
STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 90 mg of daclatasvir (as dihydrochloride).
Ena filmsko obložena tableta vsebuje 90 mg daklatasvirja (v obliki daklatasvirjevega diklorida).
STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 30 mg of daclatasvir (as dihydrochloride).
Ena filmsko obložena tableta vsebuje 30 mg daklatasvirja (v obliki daklatasvirjevega diklorida).
No dose adjustment of either medicinal product is required when Daklinza is coadministered with cyclosporine, tacrolimus, sirolimus or mycophenolate mofetil.
Daklinza in ciklosporina, takrolimusa, sirolimusa ali mofetilmikofenolata odmerka nobenega od zdravil ni treba prilagajati.
Expected due to inhibition of OATP 1B1 and/or BCRP by daclatasvir:
OATP 1B1 in/ali BCRP z daklatasvirjem: ↑ koncentracija statina
NNRTI-based Other
na osnovi PI na osnovi NNRTI drugo brez
This is because Daklinza may affect the way some medicines work.
Zdravilo Daklinza lahko vpliva na delovanje nekaterih drugih zdravil, nekatera druga zdravila pa lahko vplivajo na delovanje zdravila Daklinza.
CORTICOSTEROIDS Systemic dexamethasone
KORTIKOSTEROIDI Sistemski deksametazon
When Daklinza is used together with sofosbuvir (without ribavirin), the following side effects have been reported.
Pri uporabi zdravila Daklinza skupaj s sofosbuvirjem (brez ribavirina) so poročali o naslednjih neželenih učinkih: Zelo pogosti (pojavijo se lahko pri več kot 1 od 10 bolnikov):
Cases of severe bradycardia and heart block have been observed when Daklinza is used in combination with sofosbuvir and concomitant amiodarone with or without other drugs that lower heart rate.
Pri uporabi zdravila Daklinza v kombinaciji s sofosbuvirjem in sočasni uporabi amiodarona, skupaj z drugimi zdravili, ki upočasnjujejo srčni utrip, ali brez njih, so opazili primere hude bradikardije in srčnega bloka.
Coadministration of Daklinza with carbamazepine, oxcarbazepine, phenobarbital, phenytoin or other strong inducers of CYP3A4 is contraindicated (see section 4.3).
Daklinza s karbamazepinom, z okskarbazepinom, s fenobarbitalom, fenitoinom ali z drugimi močnimi induktorji
Virologic breakthrough
Povečanje virusnega bremena med zdravljenjem (“virologic breakthrough”)
Dose adjustment of Daklinza is recommended when coadministered with strong inhibitors of CYP3A4 (see Table 4).
Uporaba zdravila Daklinza je kontraindicirana v kombinaciji z zdravili, ki močno inducirajo CYP3A4
STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 60 mg of daclatasvir (as dihydrochloride).
Ena filmsko obložena tableta vsebuje 60 mg daklatasvirja (v obliki daklatasvirjevega diklorida).
Sirolimus Mycophenolate mofetil
Sirolimus Mofetilmikofenolat
daclatasvir + sofosbuvir + ribavirin N=5
daklatasvir + sofosbuvir + ribavirin N=5
daclatasvir + sofosbuvir + ribavirin N=9
daklatasvir + sofosbuvir + ribavirin N=9
ANTIVIRALS, HIV or HBV Protease inhibitors (PIs) Atazanavir 300 mg/ritonavir 100 mg once daily (daclatasvir 20 mg once daily)
Atazanavir 300 mg/ritonavir 100 mg enkrat na dan (daklatasvir 20 mg enkrat na dan)
Vascular disorders common hot flush
Žilne bolezni pogosti vročinski oblivi
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS CALENDAR BLISTER (NON-PERFORATED) TEXT
BESEDILO NA KOLEDARSKEM (NEPERFORIRANEM) PRETISNEM OMOTU
In study ALLY-2, the combination of daclatasvir and sofosbuvir administered for 12 weeks was evaluated in 153 adults with chronic hepatitis C and HIV co-infection; 101 patients were HCV treatment-naïve and 52 patients had failed prior HCV therapy.
V študiji ALLY-2 so proučevali uporabo kombinacije daklatasvirja in sofosbuvirja 12 tednov pri 153 odraslih s sočasno kronično okužbo z virusom hepatitisa C in virusom HIV.
The dose of Daklinza should be reduced to 30 mg once daily when coadministered with ketoconazole or other strong inhibitors of CYP3A4.
Pri sočasni uporabi ketokonazola ali drugih močnih zaviralcev CYP3A4 je treba odmerek zdravila Daklinza zmanjšati na 30 mg enkrat na dan.
Fainting
Izločanje
Expected due to CYP3A4 inhibition by boceprevir:
Pričakovano zaradi zaviranja CYP3A4 z boceprevirjem: ↑ Daklatasvir
Toxicology
ZDRAVILOM
Cases of severe bradycardia and heart block have been observed when Daklinza is used in combination with sofosbuvir and concomitant amiodarone and/or other drugs that lower heart rate (see sections 4.4 and 4.5).
Pri uporabi zdravila Daklinza v kombinaciji s sofosbuvirjem in sočasni uporabi amiodarona in/ali drugih zdravil, ki upočasnjujejo srčni utrip, so opazili primere hude bradikardije in srčnega bloka
HCV genotype:
Genotip HCV: 1a
Biotransformation
Organski sistem
D.
V
≤8.5 g/dL
≤ 8,5 g/dl ukinite ribavirin
Route of administration Immediate Packaging Pack size
Velikost pakiranja
Invented Name
EU številka Izmišljeno ime
Attenuated feline rhinotracheitis herpesvirus (FVH F2 strain): at least 4.9 log 10 CCID50 per dose Inactivated feline Calicivirosis antigens (FCV 431 and FCV G1 strains): at least 2.0 ELISA U per doses Attenuated feline Chlamydophila felis (905 strain): at least 3.0 log 10 EID50 per dose
Inaktivirani antigeni kalici virusa mačk (sev FCV 431 in sev FCV G1): ≥ 2,0 enot v testu ELISA na odmerek Atenuirana Chlamydophila felis (sev 905): ≥ 103,0 EID50 na odmerek Atenuiran virus panleukopenije mačk (PLI IV): ≥ 103,5 CCID50 na odmerek Rekombinantni poxvirus kanarčkov, ki vsebuje antigen virusa mačje levkemije (vCP97): ≥ 107,2 CCID50 na odmerek
Strength harmaceutical Form
Farmacevtska oblika
Attenuated feline panleucopenia virus (PLI IV): at least 3.5 log 10 CCID50 per dose
Inaktivirani antigeni kalici virusa mačk (sev FCV 431 in sev FCV G1): ≥ 2,0 enot v testu ELISA na odmerke Atenuirana Chlamydophila felis (sev 905): ≥ 103,0 EID50 na odmerek Atenuiran virus panleukopenije mačk (PLI IV): ≥ 103,5 CCID50 na odmerek Rekombinantni poxvirus kanarčkov, ki vsebuje antigen virusa mačje levkemije (vCP97): ≥ 107,2 CCID50 na odmerek
90 (3 x 30) tablets
Pot uporabe Stična ovojnina Velikost pakiranja plastenka (HDPE) 30 tablet plastenka (HDPE) 90 (3 x 30) tablet
Packaging Package size l t o r
Pot uporabe Ovojnina Velikost pakiranja o ā
This summary was last updated in 08-2012.
Povzetek je bil nazadnje posodobljen 08-2012.
It is used in addition to diet and exercise in the following ways:
Uporablja se kot dodatek k dieti in telesni aktivnosti na naslednje načine:
The European Commission granted a marketing authorisation valid throughout the European Union for Xelevia on 21 March 2007.
Evropska komisija je dovoljenje za promet z zdravilom Xelevia, veljavno po vsej Evropski uniji, odobrila dne 21. marca 2007.
Xelevia is taken at a dose of 100 mg once a day.
Zdravilo Xelevia se jemlje v odmerku 100 mg enkrat na dan.
The full EPAR for Xelevia can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Xelevia je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
EPAR summary for the public sitagliptin
Povzetek EPAR za javnost sitagliptin
What benefit has Xelevia shown during the studies?
Kakšne koristi je zdravilo Xelevia izkazalo med študijami?
This is a summary of the European public assessment report (EPAR) for Xelevia.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Xelevia.
Other information about Xelevia
Druge informacije o zdravilu Xelevia
For more information about treatment with Xelevia, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Xelevia preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
Xelevia must not be used in people who are hypersensitive (allergic) to sitagliptin or any of the other ingredients.
Zdravila Xelevia ne smejo uporabljati osebe, ki so preobčutljive za (alergične na) sitagliptin ali katero koli drugo sestavino zdravila.
In patients with moderately or severely reduced kidney function the dose of Xelevia should be reduced.
Pri bolnikih z delno ali močno okrnjenim delovanjem ledvic je treba odmerek zdravila Xelevia zmanjšati.
It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Xelevia.
Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo Xelevia, na podlagi česar je oblikoval mnenje za odobritev dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
Serious side effects reported with Xelevia (generally seen in more than 5% of patients) include pancreatitis (inflammation of the pancreas) and hypersensitivity (allergic reactions).
Med resnimi neželenimi učinki, o katerih so poročali pri uporabi zdravila Xelevia (običajno opaženi pri več kot 5 % bolnikov) so pankreatitis (vnetje trebušne slinavke) in preobčutljivostne (alergijske) reakcije.
In the studies comparing Xelevia with other medicines, the effectiveness of adding Xelevia to metformin was similar to that of adding glipizide.
V študijah, v katerih so zdravilo Xelevia primerjali z drugimi zdravili, je bila učinkovitost dodajanja zdravila Xelevia metforminu podobna kot pri dodajanju glipizida.
If Xelevia is taken with a sulphonylurea or insulin, the dose of the sulphonylurea or insulin may need to be lowered to reduce the risk of hypoglycaemia (low blood sugar levels).
Če se zdravilo Xelevia jemlje s sulfonilsečnino ali insulinom, bo morda treba odmerek sulfonilsečnine ali insulina znižati, da se zmanjša tveganje za hipoglikemijo (nizko koncentracijo sladkorja v krvi).
The active substance in Xelevia, sitagliptin, is a dipeptidyl-peptidase-4 (DPP-4) inhibitor.
Zdravilna učinkovina zdravila Xelevia je sitagliptin, ki je zaviralec dipeptidil peptidaze-4 (DPP-4).
• two studies compared Xelevia with other antidiabetes medicines.
• v dveh študijah so zdravilo Xelevia primerjali z drugimi zdravili proti sladkorni bolezni.
Sitagliptin does not work when the blood glucose is low.
Sitagliptin ne deluje, če je vrednost glukoze v krvi nizka.
What is the risk associated with Xelevia?
Kakšna tveganja so povezana z zdravilom Xelevia?
Xelevia was more effective than placebo when it was taken alone or in combination with other antidiabetes medicines.
Zdravilo Xelevia je bilo učinkovitejše od placeba, ko so ga bolniki jemali kot samostojno zdravilo ali v kombinaciji z drugimi zdravili proti sladkorni bolezni.
Why has Xelevia been approved?
Zakaj je bilo zdravilo Xelevia odobreno?
Xelevia was studied in nine studies, involving almost 6,000 patients with type 2 diabetes whose blood glucose levels were not adequately controlled:
Zdravilo Xelevia je bilo raziskano v devetih glavnih študijah, ki so vključevale skoraj 6 000 bolnikov s sladkorno boleznijo tipa 2, pri katerih ravni glukoze v krvi niso bile zadostno nadzorovane:
Type 2 diabetes is a disease in which the pancreas does not make enough insulin to control the level of glucose in the blood or when the body is unable to use insulin effectively.
Sladkorna bolezen tipa 2 je bolezen, pri kateri trebušna slinavka ne tvori dovolj insulina za nadzor ravni glukoze v krvi ali pri kateri telo ne more učinkovito izrabiti insulina.
These hormones are released after a meal and stimulate the pancreas to produce insulin.
Ti hormoni se sproščajo po obroku in stimulirajo trebušno slinavko k tvorjenju insulina.
Xelevia is a medicine that contains the active substance sitagliptin.
Xelevia je zdravilo, ki vsebuje zdravilno učinkovino sitagliptin.
The CHMP decided that Xelevia's benefits are greater than its risks and recommended that it be given marketing authorisation.
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da so koristi zdravila Xelevia večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
Hypoglycaemia has been reported in combination with a sulphonylurea in 4.7-13.8% of patients and with insulin in 9.6% of patients.
V kombinaciji s sulfonilsečnino je prišlo do hipoglikemije pri 4,7-13,8 % bolnikov, v kombinaciji z insulinom pa pri 9,6 % bolnikov.
In all of the 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 ravni glikoziliranega hemoglobina (HbA1c) v krvi, ki kaže na učinkovitost nadzora ravni glukoze v krvi.
Xelevia is used in patients with type 2 diabetes to improve the control of blood glucose (sugar) levels.
Zdravilo Xelevia se uporablja za zdravljenje bolnikov s sladkorno boleznijo tipa 2 za izboljšanje nadzora nad ravnjo glukoze (sladkorja) v krvi.
It works by blocking the breakdown of ‘incretin' hormones in the body.
Deluje tako, da zavre razgradnjo hormonov inkretinov v telesu.
In patients taking Xelevia on its own, HbA1c levels fell from around 8.0% at the start of the studies by 0.48% after 18 weeks and 0.61% after 24 weeks.
Pri bolnikih, ki so jemali samo zdravilo Xelevia so se ravni HbA1c zmanjšale za približno 8 % na začetku študij, za 0,48 % po 18 tednih in za 0,61 % po
By increasing levels of incretin hormones in the blood, sitagliptin stimulates the pancreas to produce more insulin when blood glucose levels are high.
Sitagliptin s povečanjem ravni inkretinskih hormonov v krvi spodbudi trebušno slinavko k tvorjenju večjih količin insulina, kadar so ravni glukoze v krvi previsoke.
For the full list of all side effects reported with Xelevia, see the package leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Xelevia, glejte navodilo za uporabo.
When taken on their own, Xelevia and metformin produced similar reductions in HbA1c levels, but the effectiveness of Xelevia seemed to be slightly lower than that of metformin.
Ob samostojnem jemanju zdravila Xelevia ali metformina so bila znižanja ravni HbA1c podobna, vendar je bilo zdravilo Xelevia malenkost slabše učinkovito kot metformin.
• four of the studies compared Xelevia with placebo (a dummy treatment): Xelevia or placebo were used on their own in two studies involving 1,262 patients, as an add-on to metformin in one study involving 701 patients, and as an add-on to pioglitazone (a PPAR-gamma agonist) in one study involving 353 patients;
• v štirih študijah so zdravilo Xelevia primerjali s placebom (zdravilom brez zdravilne učinkovine): zdravilo Xelevia ali placebo so bolniki jemali samostojno v dveh študijah, ki sta vključevali 1 262 bolnikov, kot dodatek metforminu v eni študiji s 701 bolnikom in kot dodatek pioglitazonu (agonistu PPAR-gama) v eni študiji s 353 bolniki;
• on its own, in patients who are not satisfactorily controlled on diet and exercise and in whom metformin (an antidiabetes medicine) is not suitable;
• samostojno pri bolnikih, katerih bolezen samo z dieto in telesno vadbo ni zadovoljivo nadzorovana in pri katerih metformin (zdravilo za zdravljenje sladkorne bolezni) ni primeren;
• three additional studies compared Xelevia with placebo when they were added to other antidiabetes medicines: glimepiride (another sulphonylurea), with or without metformin, in 441 patients; the combination of metformin and rosiglitazone (a PPAR-gamma agonist) in 278 patients; and a stable dose of insulin, with or without metformin, in 641 patients.
• v treh dodatnih študijah so zdravilo Xelevia primerjali s placebom, obe zdravili so dodajali drugim zdravilom proti sladkorni bolezni; glimepiridu (drugi vrsti sulfonilsečnine), z metforminom ali brez njega, pri 441 bolnikih ali kombinaciji metformina in rosiglitazona (agonista PPAR-gama) pri 278 bolnikih ali ustaljenemu odmerku insulina, z metforminom ali brez njega, pri 641 bolnikih.
• in combination with both metformin, and a sulphonylurea or a PPAR-gamma agonist, in patients who are not satisfactorily controlled on the two medicines;
• v kombinaciji z metforminom in sulfonilsečnino ali agonistom PPAR-gama pri bolnikih, pri katerih z obema zdraviloma ni vzpostavljen zadosten nadzor;
The other study compared Xelevia with metformin, used on their own, in 1,058 patients;
V drugi študiji so zdravilo Xelevia primerjali z metforminom pri 1 058 bolnikih, ki so obe zdravili jemali samostojno;
HbA1c levels were reduced by 1.03% after 18 weeks in patients adding Xelevia to metformin and rosiglitazone, compared with a fall of 0.31% in those adding placebo.
Ravni HbA1c so bile po 18 tednih znižane za 1,03 % pri bolnikih, ki so zdravilo Xelevia dodajali metforminu in rosiglitazonu, v primerjavi z znižanjem za 0,31 % pri tistih, ki so kot dodatek prejemali placebo.
What is Xelevia used for?
Za kaj se zdravilo Xelevia uporablja?
• in combination with metformin or a PPAR-gamma agonist (a type of antidiabetes medicine) such as a thiazolidinedione, in patients who are not satisfactorily controlled on metformin or the PPAR-gamma agonist used on its own;
• v kombinaciji z metforminom ali agonistom PPAR-gama (vrsto zdravila proti sladkorni bolezni), kot je tiazolidinedion, pri bolnikih, katerih bolezen samo z metforminom ali agonistom PPAR-gama ni zadovoljivo nadzorovana;
• in combination with insulin, with or without metformin, in patients who are not satisfactorily controlled on a stable dose of insulin.
• v kombinaciji z insulinom z metforminom ali brez njega, pri bolnikih, pri katerih z ustaljenim odmerkom insulina ni vzpostavljen zadosten nadzor.
• in combination with a sulphonylurea (another type of antidiabetes medicine) in patients who are not satisfactorily controlled with a sulphonylurea used on its own and in whom metformin is not suitable;
• v kombinaciji s sulfonilsečnino (vrsto zdravila proti sladkorni bolezni) pri bolnikih, pri katerih bolezen samo s sulfonilsečnino ni zadovoljivo nadzorovana, metformin pa zanje ni primeren;
Finally, they were reduced by 0.59% in patients adding Xelevia to insulin (with or without metformin), compared with a fall of 0.03% in those adding placebo.
Ravni so se znižale za 0,59 % pri bolnikih, ki so zdravilo Xelevia dodajali insulinu (z metforminom ali brez njega) v primerjavi z zmanjšanjem za 0,03 % pri tistih, ki so kot dodatek jemali placebo.
In the additional studies, adding Xelevia to glimepiride (with or without metformin) led to a reduction in HbA1c levels of 0.45% after 24 weeks, compared with an increase of 0.28% in those adding placebo.
V dodatnih študijah je dodajanje zdravila Xelevia glimepiridu (z metforminom ali brez njega) po 24 tednih znižalo ravni HbA1c za 0,45 % v primerjavi s povečanjem za 0,28 % pri bolnikih, pri katerih so dodajali placebo.
How has Xelevia been studied?
Kako je bilo zdravilo Xelevia raziskano?
How is Xelevia used?
Kako se zdravilo Xelevia uporablja?
What is Xelevia?
Kaj je zdravilo Xelevia?
How does Xelevia work?
Kako zdravilo Xelevia deluje?
When added to pioglitazone, Xelevia reduced HbA1c levels by 0.85% after 24 weeks, compared with a fall of 0.15% in the patients adding placebo.
Če je bilo zdravilo Xelevia dodano pioglitazonu, je po 24 tednih znižalo ravni HbA1c za 0,85 % v primerjavi z znižanjem za 0,15 % pri bolnikih, ki so kot dodatek jemali placebo.