FrancophonIA/ELRC3.0 huggingface dataset:
English: You should use it on the same day each week if you can. To help you remember, you may wish to tick the day of the week when you inject your first dose on the box that your syringe comes in, or on a calendar.
Slovenian: Da si boste lažje zapomnili, si lahko dan v tednu, ko vzamete svoj prvi odmerek zdravila Trulicity, označite na škatlici vašega injekcijskega peresnika ali pa na koledarju.
English: Use a new pen for your injection.
Slovenian: Za injiciranje uporabite nov peresnik.
English: 1500-2000 mg/day (n=268)
Slovenian: 2000 mg/dan (n=268)
English: No cases of severe hypoglycaemia were observed.
Slovenian: Primerov hude hipoglikemije niso opazili.
English: Contents of the pack and other information
Slovenian: Shranjevanje zdravila Trulicity Vsebina pakiranja in dodatne informacije
English: Ten patients reported severe hypoglycaemia with Trulicity 1.5 mg, seven with Trulicity 0.75 mg, and fifteen with insulin glargine.
Slovenian: Deset bolnikov je poročalo o hudi hipoglikemiji z zdravilom Trulicity 1,5 mg, sedem z zdravilom Trulicity 0,75 mg in petnajst z insulinom glarginom.
English: No patients reported cases of severe hypoglycaemia with Trulicity 1.5 mg, six with Trulicity 0.75 mg, and seventeen with insulin glargine.
Slovenian: Noben bolnik ni poročal o hudi hipoglikemiji z zdravilom Trulicity 1,5 mg, šest z zdravilom Trulicity 0,75 mg in sedemnajst z insulinom glarginom.
English: Insulin glargine+ once daily (n=296)
Slovenian: Insulin glargin+ enkrat na dan (n=296)
English: *Produced in CHO cells by recombinant DNA technology.
Slovenian: *Pridobljeno s tehnologijo rekombinantne DNA v celicah jajčnikov kitajskega hrčka.
English: The effect of dulaglutide on blood pressure as assessed by Ambulatory Blood Pressure Monitoring was evaluated in a study of 755 patients with type 2 diabetes.
Slovenian: Učinek dulaglutida na krvni tlak, ocenjen med 24-urnim merjenjem krvnega tlaka, je bil ocenjen v študiji s
English: Inject your dose using another pen.
Slovenian: Svoj odmerek si injicirajte z drugim peresnikom.
English: Pull off and discard the grey base cap.
Slovenian: • Snemite in zavrzite sivi pokrovček dna.
English: Table 11: Results of a 52 week active controlled study with two doses of dulaglutide in comparison to insulin glargine (in patients with moderate to severe chronic kidney disease)
Slovenian: Preglednica 11: Rezultati 52-tedenske študije, nadzorovane z aktivno primerjavo, z dvema odmerkoma dulaglutida v primerjavi z insulinom glarginom (pri bolnikih z zmerno do hudo kronično ledvično boleznijo)
English: Baseline HbA1c
Slovenian: Izhodiščna vrednost HbA1c
English: The mean volume of distribution after subcutaneous administration of dulaglutide 0.75 mg and 1.5 mg at steady state in patients with type 2 diabetes mellitus were approximately 19.2 L and 17.4 L.
Slovenian: Povprečni volumen porazdelitve po subkutani aplikaciji dulaglutida 0,75 mg in 1,5 mg v stanju dinamičnega ravnovesja je bil pri bolnikih s sladkorno boleznijo tipa 2 približno 19,2 l in 17,4 l. Biotransformacija
English: There are no or limited amount of data from the use of dulaglutide in pregnant women.
Slovenian: V zvezi z uporabo dulaglutida pri nosečnicah ni podatkov ali pa so podatki omejeni.
English: Combination therapy with sulphonylurea
Slovenian: Kombinirano zdravljenje s sulfonilsečnino
English: Very common: may affect more than 1 in 10 people - Nausea (feeling sick) - Vomiting (being sick) - Diarrhoea - Abdominal (stomach) pain.
Slovenian: Zelo pogosti lahko se pojavijo pri več kot 1 od 10 bolnikov - navzea (občutek slabosti s siljenjem na bruhanje) - bruhanje - driska
English: Skin and subcutaneous tissue disorders
Slovenian: Bolezni kože in podkožja angioedem#
English: No cases of severe hypoglycaemia with dulaglutide were observed.
Slovenian: Primerov hude hipoglikemije pri uporabi dulaglutida niso opazili.
English: What if there is a drop of liquid on the tip of the needle when I remove the base cap?
Slovenian: Kaj če opazim kapljico tekočine na konici igle, ko odstranim pokrovček z dna?
English: When used alone, the recommended dose is 0.75 mg once a week.
Slovenian: Ob samostojni uporabi je priporočeni odmerek 0,75 mg enkrat na teden.
English: Insulin glargine+ once daily (n=194)
Slovenian: Insulin glargin+ enkrat na dan (n=194)
English: Combination therapy with metformin and pioglitazone In a placebo and active (exenatide twice daily) controlled study, both in combination with metformin and pioglitazone, Trulicity 1.5 mg and 0.75 mg demonstrated superiority for HbA1c reduction in comparison to placebo and exenatide, accompanied by a significantly a greater percentage of patients achieving HbA1c targets of < 7.0 % or ≤ 6.5 %
Slovenian: Kombinirano zdravljenje z metforminom in pioglitazonom V študiji, nadzorovani s placebom in aktivno primerjavo (eksenatid dvakrat na dan), obakrat v kombinaciji z metforminom in pioglitazonom, se je zdravilo Trulicity 1,5 mg in 0,75 mg izkazalo za superiorno tudi pri zniževanju HbA1c v primerjavi s placebom in z eksenatidom, bistveno večji odstotek bolnikov je dosegel ciljne vrednosti HbA1c < 7,0 % ali ≤ 6,5%.
English: Fasting blood glucose
Slovenian: Krvna glukoza na tešče
English: Remove the needle from the skin.
Slovenian: Izvlecite iglo iz kože.
English: The incidences when dulaglutide 0.75 mg and 1.5 mg, respectively, were used in combination with prandial insulin were 85.3% and 80.0% and rates were 35.66 and 31.06 events/patient/year.
Slovenian: Pogostnost ob uporabi dulaglutida 0,75 mg in 1,5 mg v kombinaciji s prandialnim insulinom je bila 85,3 % oziroma 80,0 %, stopnje pa 35,66 oziroma 31,06 dogodkov/bolnika/leto.
English: The mean peak (Cmax) and total (AUC) exposures were approximately 114 ng/ml and 14,000 ngh/ml, respectively, after multiple subcutaneous 1.5 mg doses of dulaglutide in patients with type 2 diabetes.
Slovenian: Povprečna najvišja koncentracija (Cmax) in skupna izpostavljenost (AUC) sta pri bolnikih s sladkorno boleznijo tipa 2 po več subkutanih odmerkih dulaglutida 1,5 mg znašali približno 114 ng/ml in 14000 ng•h/ml.
English: • Dispose of the syringe as directed.
Slovenian: • Zavrzite injekcijsko brizgo v skladu z navodili.
English: The Trulicity treatment arm included patients ≥ 65 years (n = 2,619) and ≥ 75 years (n = 484),
Slovenian: Skupina, zdravljena z zdravilom Trulicity, je vključevala bolnike, stare ≥ 65 let (n = 2619) in ≥ 75 let (n = 484), ter bolnike z blago (n = 2435), zmerno (n = 1031) ali hudo (n = 50) okvaro ledvic.
English: Insulin glargine+ once daily (n=262)
Slovenian: Insulin glargin+ enkrat na dan (n=262)
English: Sitagliptin 100 mg once daily (n=315)
Slovenian: Sitagliptin 100 mg enkrat na dan (n=315)
English: In a 2-year carcinogenicity study in rats, at ≥ 7 times the human clinical exposure following 1.5 mg dulaglutide per week, dulaglutide caused statistically significant, dose-related increases in the incidence of thyroid C-cell tumours (adenomas and carcinomas combined).
Slovenian: V 2-letni študiji karcinogenosti pri podganah je dulaglutid povzročil statistično značilna in z odmerkom povezana povečanja incidence ščitničnih tumorjev C-celic (adenomov in karcinomov skupaj) pri izpostavljenosti, ki je bila ≥ 7kratni izpostavljenosti človeka pri klinični uporabi 1,5 mg dulaglutida na teden.
English: During the fertility studies, a reduction in the number of corpora lutea and prolonged oestrous cycle were observed at dose levels that were associated with decreased food intake and body weight gain in maternal animals; however, no effects on indices of fertility and conception or embryonic development were observed.
Slovenian: Med raziskavami plodnosti so opazili zmanjšano število rumenih telesc in podaljšan estrusni cikel pri ravneh odmerka, povezanih z zmanjšanim vnosom hrane in zmanjšanim pridobivanjem telesne mase pri materi;
English: Warnings and precautions Talk to your doctor, pharmacist or nurse before using Trulicity if:
Slovenian: Pred začetkom uporabe zdravila Trulicity se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro, če:
English: • Do not use your syringe.
Slovenian: • Injekcijske brizge ne uporabite.
English: Mean change in HbA1c
Slovenian: Povprečna sprememba vrednosti HbA1c
English: In reproductive toxicology studies, skeletal effects and a reduction in foetal growth were observed in the rat and rabbit at exposures of dulaglutide 11- to 44-fold higher than those proposed clinically, but no foetal malformations were observed.
Slovenian: Pri študijah o vplivu na sposobnost razmnoževanja je izpostavljenost dulaglutidu (11- do 44-višja od izpostavljenosti človeka pri predlagani klinični uporabi) pri brejih podganah in kuncih povzročila zmanjšano rast plodu in/ali učinke na skelet, vendar pa ni bilo dokazov o malformacijah fetusa.
English: Trulicity is to be injected subcutaneously in the abdomen, thigh or upper arm.
Slovenian: Zdravilo Trulicity je treba injicirati subkutano v trebuh, stegno ali nadlaket.
English: <7.0 %(%) ≤6.5 %(%) (mmol/L)
Slovenian: < 7,0 % in ≤ 6,5 % (Preglednica 9).
English: 2 INSERT
Slovenian: PRILOGA I
English: - Feeling less hungry (decreased appetite) - Indigestion - Constipation - Gas (flatulence) - Bloating of the stomach - Gastroesophageal reflux disease - a disease caused by stomach acid coming up into the tube from your stomach to your mouth - Burping - Feeling tired - Increased heart rate - Slowing of the electrical currents in the heart
Slovenian: - gastroezofagealna refluksna bolezen - bolezen, ki jo povzroča dvigovanje želodčne kisline iz želodca prek požiralnika v usta - spahovanje
English: • If you have any questions or problems with your Trulicity syringe, contact your doctor,
Slovenian: KJE DOBITI VEČ PODATKOV • Če imate vprašanja ali težave z vašo napolnjeno injekcijsko brizgo Trulicity, se obrnite na zdravnika,
English: With Trulicity 1.5 mg a significantly higher percentage of patients reached a target HbA1c of < 7.0 % or ≤ 6.5 % at 52 and 78 weeks compared to insulin glargine.
Slovenian: Z zdravilom Trulicity 1,5 mg je bistveno višji odstotek preiskovancev dosegel ciljno vrednost HbA1c < 7,0 % ali ≤ 6,5% po 52. in 78. tednu, v primerjavi z insulinom glarginom.
English: Treatment with Trulicity 0.75 mg or Trulicity 1.5 mg in combination with SGLT2i therapy resulted in a statistically significant reduction in HbA1c compared to placebo with SGLT2i therapy at 24 weeks.
Slovenian: Zdravljenje z zdravilom Trulicity 0,75 mg ali 1,5 mg v kombinaciji z zaviralcem SGLT2 je v 24. tednu povzročilo statistično pomembno zmanjšanje HbA1c, v primerjavi s placebom skupaj z zaviralcem SGLT2.
English: The severe hypoglycaemia event incidences were 0% and 0.7%, and rates were 0.00 and 0.01 events/patient/year for each dose, respectively.
Slovenian: Pojavnost dogodkov hude hipoglikemije je znašala 0 % oziroma 0,7 %, stopnje pa 0,00 oziroma 0,01 dogodkov/bolnika/leto za vsak odmerek.
English: Hepatic impairment No dosage adjustment is required in patients with hepatic impairment.
Slovenian: Okvarjeno delovanje jeter Pri bolnikih z okvarjenim delovanjem jeter prilagoditev odmerka ni potrebna.
English: Very common Common Uncommon
Slovenian: Neznana pogostnost
English: The incidence of documented symptomatic hypoglycaemia when dulaglutide 1.5 mg was used in combination with insulin glargine was 35.3% and the rate was 3.38 events/patient/year.
Slovenian: Pogostnost dokumentirane simptomatske hipoglikemije ob uporabi dulaglutida 1,5 mg v kombinaciji z insulinom glarginom je bila 35,3 %, stopnja pa 3,38 dogodkov/bolnika/leto.
English: The severe hypoglycaemia event incidence was 0.7% and the rate was 0.01 events/patient/year.
Slovenian: Pogostnost dogodkov hude hipoglikemije je bila 0,7 %, stopnja pa je bila 0,01 dogodkov/bolnika/leto.
English: Treatment with dulaglutide resulted in significant reductions from baseline in fasting blood glucose.
Slovenian: Zdravljenje z dulaglutidom je povzročilo značilna znižanja koncentracij glukoze na tešče od izhodišča.
English: You may use the same area of your body, but be sure to choose a different injection site in that area.
Slovenian: Vendar pa morate na tem delu telesa izbirati različna mesta injiciranja.
English: ANNEX II A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
Slovenian: B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE C. DRUGI POGOJI IN ZAHTEVE DOVOLJENJA ZA PROMET Z ZDRAVILOM
English: 10 mcg twice daily (n=276)
Slovenian: Eksenatid+ 10 mcg dvakrat na dan (n=276)
English: One patient reported severe hypoglycaemia with Trulicity 1.5 mg in combination with insulin glargine and none with placebo.
Slovenian: En bolnik je poročal o hudi hipoglikemiji pri zdravilu Trulicity 1,5 mg v kombinaciji z insulinom glarginom; noben bolnik ni poročal o hudi hipoglikemiji pri placebu.
English: Talk to your doctor if you would like to or are breast-feeding before taking this medicine.
Slovenian: Preden vzamete to zdravilo, se pogovorite z zdravnikom, če želite dojite ali če že dojite.
English: AUCINR increased by 2 %, which is unlikely to be clinically significant, and there was no effect on maximum international normalised ratio response (INRmax).
Slovenian: Vpliva na največje mednarodno umerjeno razmerje odzivov (INRmax) ni bilo.
English: If pancreatitis is suspected, dulaglutide should be discontinued.
Slovenian: Ob sumu na pankreatitis je treba zdravljenje z dulaglutidom prekiniti.
English: Dispose of the pen in a sharps container or as directed by your doctor, pharmacist or nurse.
Slovenian: • Peresnik odložite v vsebnik za ostre odpadke oz. skladno z navodili zdravnika, farmacevta ali medicinske sestre .
English: 50019, Sesto Fiorentino
Slovenian: Via Gramsci 731/733 50019, Sesto Fiorentino Firenze (FI) Italija
English: Severe side effects
Slovenian: Resni neželeni učinki
English: Do not use Trulicity if you are breast-feeding.
Slovenian: Trulicity ne uporabljajte.
English: Trulicity should not be used if particles appear or if the solution is cloudy and/or discoloured.
Slovenian: Zdravila Trulicity ne smete uporabiti, če v njem opazite delce ali če je raztopina motna in/ali spremenjene barve.
English: The mean t1/2 of atorvastatin and o-hydroxyatorvastatin were increased by 17 % and 41 %, respectively, following dulaglutide administration.
Slovenian: Povprečni razpolovni čas t1/2 atorvastatina in o-hidroksiatorvastatina se je povečal za 17 % in 41 % po aplikaciji dulaglutida, vendar se to ni štelo kot klinično pomembno, zato pri aplikaciji z dulaglutidom prilagoditev odmerka atorvastatina ni potrebna.
English: Uncommon: may affect up to 1 in 100 people - Injection site reactions (e.g. rash or redness) - Allergic reactions (hypersensitivity) (e.g. swelling, raised itchy skin rash (hives)) - Dehydration, often associated with nausea, vomiting and/or diarrhoea - Gallstones - Inflamed gallbladder
Slovenian: Občasni:pojavijo se lahko pri največ 1 od 100 bolnikov: - reakcije na mestu injiciranja (npr. izpuščaj ali rdečina) - alergične reakcije (preobčutljivost) (npr. otekanje, dvignjen in srbeč kožni izpuščaj (koprivnica))
English: The incidences of documented symptomatic hypoglycaemia when dulaglutide 0.75 mg and 1.5 mg, respectively, were used in combination with a sulphonylurea and metformin were 39.0% and 40.3% and the rates were 1.67 and 1.67 events/patient/year.
Slovenian: Pogostnost dokumentirane simptomatske hipoglikemije ob uporabi dulaglutida 0,75 mg in 1,5 mg v kombinaciji s sulfonilsečnino in metforminom je bila 39,0 % oziroma 40,3 %, stopnje pa 1,67 oziroma 1,67 dogodkov/bolnika/leto.
English: • The pen is a disposable, pre-filled delivery device that is ready to use.
Slovenian: • Napolnjen injekcijski peresnik je napolnjen pripomoček za dostavo zdravila, za takojšnjo uporabo.
English: Similar results for SBP and DBP were demonstrated at the final 26 week time point of the study.
Slovenian: Podobne rezultate za sistolni krvni tlak in diastolni krvni tlak so opazili v zadnji časovni točki 26.
English: Table 3: Results of a 104 week placebo and active controlled study with two doses of dulaglutide in comparison to sitagliptin
Slovenian: Preglednica 3: Rezultati 104-tedenske študije, nadzorovane s placebom in aktivno primerjavo z dvema odmerkoma zdravila Trulicity v primerjavi z sitagliptinom
English: • Store the syringe in the original package in order to protect from light.
Slovenian: • Zdravilo Trulicity shranjujte v originalni ovojnini za zagotovitev zaščite pred svetlobo.
English: Combination therapy with metformin and sulphonylurea In an active controlled study of 78 weeks duration, dulaglutide was compared to insulin glargine, both on a background of metformin and a sulphonylurea.
Slovenian: V študiji z aktivno primerjavo, ki je trajala 78 tednov, so dulaglutid primerjali z insulinom glarginom, oboje ob osnovnem zdravljenju z metforminom in sulfonilsečnino.
English: At 26 weeks, both Trulicity 1.5 mg and 0.75 mg were non-inferior to insulin glargine in lowering of HbA1c and this effect was sustained at 52 weeks.
Slovenian: V 26. tednu sta oba odmerka zdravila Trulicity, 1,5 mg in 0,75 mg, izkazovala neinferiornost v primerjavi z insulinom glarginom pri zniževanju HbA1c in ta učinek se je ohranil do 52. tedna.
English: 2 pre-filled pens of 0.5 ml solution 4 pre-filled pens of 0.5 ml solution
Slovenian: 2 napolnjena injekcijska peresnika z 0,5 ml raztopine 4 napolnjeni injekcijski peresniki z 0,5 ml raztopine
English: 4 pre-filled syringes of 0.5 ml solution
Slovenian: 4 napolnjene injekcijske brizge z 0,5 ml raztopine
English: The rates of documented symptomatic hypoglycaemia with Trulicity 1.5 mg and insulin glargine were 3.38 episodes/patient/year compared to placebo and insulin glargine 4.38 episodes/patient/year.
Slovenian: Stopnja dokumentirane simptomatske hipoglikemije za zdravilo Trulicity 1,5 mg in insulin glargin je bila 3,38 epizod/bolnika/leto v primerjavi s placebom in insulinom glarginom, kjer je stopnja znašala 4,38 epizod/bolnika/leto.
English: Sitagliptin 100 mg once daily (n=315) †† multiplicity adjusted 1-sided p-value < 0.025, for superiority of dulaglutide compared to sitagliptin, assessed only for HbA1c at 52 and 104 weeks ‡‡ multiplicity adjusted 1-sided p-value < 0.001 for superiority of dulaglutide compared to placebo,
Slovenian: Sitagliptin 100 mg enkrat na dan (n=315) †† Enostranska vrednost p < 0, 025, za superiorno učinkovitost dulaglutida v primerjavi s sitagliptinom, ocenjena le za vrednost HbA1c po 52. in 104. tednu.
English: Table 4: Results of a 26 week active controlled study of one dose of dulaglutide in comparison to liraglutide
Slovenian: Preglednica 4: Rezultati 26-tedenske študije, nadzorovane z aktivno primerjavo z enim odmerkom zdravila Trulicity v primerjavi z liraglutidom
English: At 26 weeks, both Trulicity 1.5 mg and 0.75mg were superior to insulin glargine in lowering of HbA1c and this effect was sustained at 52 weeks.
Slovenian: Po 26 tednih je bilo zdravilo Trulicity 1,5 mg in 0,75 mg superiorno od insulina glargina pri zniževanju HbA1c in ta učinek se je ohranil do 52. tedna.
English: When dulaglutide 0.75 mg and 1.5 mg were used as monotherapy or in combination with metformin alone or metformin and pioglitazone, the incidences of documented symptomatic hypoglycaemia were 5.9% to 10.9% and the rates were 0.14 to 0.62 events/patient/year, and no episodes of severe hypoglycaemia were reported.
Slovenian: Ko so dulaglutid 0,75 mg in 1,5 mg uporabljali v monoterapiji ali v kombinaciji s samim metforminom ali z metforminom in pioglitazonom, je bila pogostnost dokumentirane simptomatske hipoglikemije od 5,9 % do
English: • Do not continue to use your syringe.
Slovenian: • Injekcijske brizge ne uporabljajte naprej.
English: Table 6: Results of a 24 week placebo controlled study of dulaglutide as add-on to glimepiride
Slovenian: Preglednica 6: Rezultati 24-tedenske študije, nadzorovane s placebom, z dulaglutidom kot dodatkom glimepiridu
English: Do not use this medicine after the expiry date which is stated on the syringe label and on the carton after EXP.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na oznaki injekcijske brizge in na škatli poleg oznake„Uporabno do/EXP“.Rok uporabnosti zdravila se izteče na zadnji dan navedenega meseca.
English: Plunger Rod
Slovenian: Spol in rasa
English: What if I see an air bubble in my Syringe?
Slovenian: Kaj moram narediti, če v svojem peresniku opazim zračni mehurček?
English: No dose adjustment of paracetamol is necessary when administered with dulaglutide.
Slovenian: Pri sočasnem dajanju paracetamola z dulaglutidom prilagajanje odmerkov paracetamola ni potrebno.
English: No cases of severe hypoglycaemia were observed for dulaglutide and two cases of severe hypoglycaemia were observed with exenatide twice daily.
Slovenian: Opazili pa so dva primera hude hipoglikemije z eksenatidom dvakrat na dan.
English: ABOUT TRULICITY PRE-FILLED SYRINGE
Slovenian: O NAPOLNJENI INJEKCIJSKI BRIZGI TRULICITY
English: Dehydration, sometimes leading to acute renal failure or worsening renal impairment, has been reported in patients treated with dulaglutide, especially at the initiation of treatment.
Slovenian: Pri bolnikih, zdravljenih z dulaglutidom, so poročali o dehidraciji, še posebno v začetku zdravljenja, ki je včasih privedla do akutne ledvične odpovedi ali poslabšanja ledvične okvare.
English: The rate of documented symptomatic hypoglycaemia with Trulicity 1.5 mg was 0.12 episodes/patient/year and with liraglutide was 0.29 episodes/patient/year.
Slovenian: Stopnja dokumentirane simptomatske hipoglikemije za zdravilo Trulicity 1,5 mg je bila 0,12 epizod/bolnika/leto, za liraglutid pa 0,29 epizod/bolnika/leto.
English: Monotherapy The recommended dose is 0.75 mg once weekly.
Slovenian: Priporočeni odmerek je 0,75 mg enkrat na teden.
English: What Trulicity looks like and contents of the pack Trulicity is a clear, colourless, solution for injection in a pre-filled syringe.
Slovenian: Zdravilo Trulicity je bistra, brezbarvna raztopina za injiciranje v napolnjeni injekcijski brizgi za enkratno uporabo.
English: • Do not freeze your syringe.
Slovenian: • Injekcijske brizge ne zamrzujte.
English: Dulaglutide also slows gastric emptying.
Slovenian: Dulaglutid prav tako upočasni praznjenje želodca.
English: There is very limited experience in patients with end stage renal disease (<15 ml/min/1.73m2), therefore Trulicity cannot be recommended in this population (see sections 5.1 and 5.2).
Slovenian: Pri bolnikih z ledvično boleznijo v zadnjem stadiju (< 15 ml/min/1,73m2) so izkušnje zelo omejene.
English: Coadministration of dulaglutide with atorvastatin decreased Cmax and AUC(0-∞) up to 70 % and 21 %, respectively, for atorvastatin and its major metabolite o-hydroxyatorvastatin.
Slovenian: Sočasna aplikacija dulaglutida z atorvastatinom je za atorvastatin in njegov glavni presnovek ohidroksiatorvastatin povzročila znižanje vrednosti do 70 % za Cmax in 21 % za AUC.
English: Table 9: Results of a 28 week study of dulaglutide compared to placebo as add-on to titrated insulin glargine
Slovenian: Preglednica 9: Rezultati 28-tedenske študije, nadzorovane s placebom, z dulaglutidom kot dodatkom titriranemu insulinu glarginu
English: Read the “Instructions for Use” for the syringe carefully before using Trulicity.
Slovenian: Pred uporabo zdravila Trulicity natančno preberite „Navodila za uporabo“ peresnika.
English: Table 5: Results of a 78 week active controlled study with two doses of dulaglutide in comparison to insulin glargine
Slovenian: Preglednica 5: Rezultati 78-tedenske študije, nadzorovane z aktivno primerjavo z dvema odmerkoma zdravila Trulicity v primerjavi z insulinom glarginom
English: The rates of documented symptomatic hypoglycaemia with Trulicity 1.5 mg and 0.75 mg, and insulin glargine were 1.67, 1.67, and 3.02 episodes/patient/year, respectively.
Slovenian: Stopnja dokumentirane simptomatske hipoglikemije za zdravilo Trulicity 1,5 mg in 0,75 mg ter insulin glargin je bila 1,67, 1,67, in 3,02 epizod/bolnika/leto.