natgillin/translations-raw huggingface dataset:
- 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
- gastroezofagealna refluksna bolezen - bolezen, ki jo povzroča dvigovanje želodčne kisline iz želodca prek požiralnika v usta - spahovanje
• If you have any questions or problems with your Trulicity syringe, contact your doctor,
KJE DOBITI VEČ PODATKOV • Če imate vprašanja ali težave z vašo napolnjeno injekcijsko brizgo Trulicity, se obrnite na zdravnika,
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.
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.
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.
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.
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.
Pojavnost dogodkov hude hipoglikemije je znašala 0 % oziroma 0,7 %, stopnje pa 0,00 oziroma 0,01 dogodkov/bolnika/leto za vsak odmerek.
Hepatic impairment No dosage adjustment is required in patients with hepatic impairment.
Okvarjeno delovanje jeter Pri bolnikih z okvarjenim delovanjem jeter prilagoditev odmerka ni potrebna.
Very common Common Uncommon
Neznana pogostnost
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.
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.
The severe hypoglycaemia event incidence was 0.7% and the rate was 0.01 events/patient/year.
Pogostnost dogodkov hude hipoglikemije je bila 0,7 %, stopnja pa je bila 0,01 dogodkov/bolnika/leto.
Treatment with dulaglutide resulted in significant reductions from baseline in fasting blood glucose.
Zdravljenje z dulaglutidom je povzročilo značilna znižanja koncentracij glukoze na tešče od izhodišča.
You may use the same area of your body, but be sure to choose a different injection site in that area.
Vendar pa morate na tem delu telesa izbirati različna mesta injiciranja.
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
B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE C. DRUGI POGOJI IN ZAHTEVE DOVOLJENJA ZA PROMET Z ZDRAVILOM
10 mcg twice daily (n=276)
Eksenatid+ 10 mcg dvakrat na dan (n=276)
One patient reported severe hypoglycaemia with Trulicity 1.5 mg in combination with insulin glargine and none with placebo.
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.
Talk to your doctor if you would like to or are breast-feeding before taking this medicine.
Preden vzamete to zdravilo, se pogovorite z zdravnikom, če želite dojite ali če že dojite.
AUCINR increased by 2 %, which is unlikely to be clinically significant, and there was no effect on maximum international normalised ratio response (INRmax).
Vpliva na največje mednarodno umerjeno razmerje odzivov (INRmax) ni bilo.
If pancreatitis is suspected, dulaglutide should be discontinued.
Ob sumu na pankreatitis je treba zdravljenje z dulaglutidom prekiniti.
Dispose of the pen in a sharps container or as directed by your doctor, pharmacist or nurse.
• Peresnik odložite v vsebnik za ostre odpadke oz. skladno z navodili zdravnika, farmacevta ali medicinske sestre .
50019, Sesto Fiorentino
Via Gramsci 731/733 50019, Sesto Fiorentino Firenze (FI) Italija
Severe side effects
Resni neželeni učinki
Do not use Trulicity if you are breast-feeding.
Trulicity ne uporabljajte.
Trulicity should not be used if particles appear or if the solution is cloudy and/or discoloured.
Zdravila Trulicity ne smete uporabiti, če v njem opazite delce ali če je raztopina motna in/ali spremenjene barve.
The mean t1/2 of atorvastatin and o-hydroxyatorvastatin were increased by 17 % and 41 %, respectively, following dulaglutide administration.
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.
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
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))
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.
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.
• The pen is a disposable, pre-filled delivery device that is ready to use.
• Napolnjen injekcijski peresnik je napolnjen pripomoček za dostavo zdravila, za takojšnjo uporabo.
Similar results for SBP and DBP were demonstrated at the final 26 week time point of the study.
Podobne rezultate za sistolni krvni tlak in diastolni krvni tlak so opazili v zadnji časovni točki 26.
Table 3: Results of a 104 week placebo and active controlled study with two doses of dulaglutide in comparison to sitagliptin
Preglednica 3: Rezultati 104-tedenske študije, nadzorovane s placebom in aktivno primerjavo z dvema odmerkoma zdravila Trulicity v primerjavi z sitagliptinom
• Store the syringe in the original package in order to protect from light.
• Zdravilo Trulicity shranjujte v originalni ovojnini za zagotovitev zaščite pred svetlobo.
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.
V študiji z aktivno primerjavo, ki je trajala 78 tednov, so dulaglutid primerjali z insulinom glarginom, oboje ob osnovnem zdravljenju z metforminom in sulfonilsečnino.
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.
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.
2 pre-filled pens of 0.5 ml solution 4 pre-filled pens of 0.5 ml solution
2 napolnjena injekcijska peresnika z 0,5 ml raztopine 4 napolnjeni injekcijski peresniki z 0,5 ml raztopine
4 pre-filled syringes of 0.5 ml solution
4 napolnjene injekcijske brizge z 0,5 ml raztopine
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.
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.
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,
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.
Table 4: Results of a 26 week active controlled study of one dose of dulaglutide in comparison to liraglutide
Preglednica 4: Rezultati 26-tedenske študije, nadzorovane z aktivno primerjavo z enim odmerkom zdravila Trulicity v primerjavi z liraglutidom
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.
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.
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.
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
• Do not continue to use your syringe.
• Injekcijske brizge ne uporabljajte naprej.
Table 6: Results of a 24 week placebo controlled study of dulaglutide as add-on to glimepiride
Preglednica 6: Rezultati 24-tedenske študije, nadzorovane s placebom, z dulaglutidom kot dodatkom glimepiridu
Do not use this medicine after the expiry date which is stated on the syringe label and on the carton after EXP.
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.
Plunger Rod
Spol in rasa
What if I see an air bubble in my Syringe?
Kaj moram narediti, če v svojem peresniku opazim zračni mehurček?
No dose adjustment of paracetamol is necessary when administered with dulaglutide.
Pri sočasnem dajanju paracetamola z dulaglutidom prilagajanje odmerkov paracetamola ni potrebno.
No cases of severe hypoglycaemia were observed for dulaglutide and two cases of severe hypoglycaemia were observed with exenatide twice daily.
Opazili pa so dva primera hude hipoglikemije z eksenatidom dvakrat na dan.
ABOUT TRULICITY PRE-FILLED SYRINGE
O NAPOLNJENI INJEKCIJSKI BRIZGI TRULICITY
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.
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.
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.
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.
Monotherapy The recommended dose is 0.75 mg once weekly.
Priporočeni odmerek je 0,75 mg enkrat na teden.
What Trulicity looks like and contents of the pack Trulicity is a clear, colourless, solution for injection in a pre-filled syringe.
Zdravilo Trulicity je bistra, brezbarvna raztopina za injiciranje v napolnjeni injekcijski brizgi za enkratno uporabo.
• Do not freeze your syringe.
• Injekcijske brizge ne zamrzujte.
Dulaglutide also slows gastric emptying.
Dulaglutid prav tako upočasni praznjenje želodca.
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).
Pri bolnikih z ledvično boleznijo v zadnjem stadiju (< 15 ml/min/1,73m2) so izkušnje zelo omejene.
Coadministration of dulaglutide with atorvastatin decreased Cmax and AUC(0-∞) up to 70 % and 21 %, respectively, for atorvastatin and its major metabolite o-hydroxyatorvastatin.
Sočasna aplikacija dulaglutida z atorvastatinom je za atorvastatin in njegov glavni presnovek ohidroksiatorvastatin povzročila znižanje vrednosti do 70 % za Cmax in 21 % za AUC.
Table 9: Results of a 28 week study of dulaglutide compared to placebo as add-on to titrated insulin glargine
Preglednica 9: Rezultati 28-tedenske študije, nadzorovane s placebom, z dulaglutidom kot dodatkom titriranemu insulinu glarginu
Read the “Instructions for Use” for the syringe carefully before using Trulicity.
Pred uporabo zdravila Trulicity natančno preberite „Navodila za uporabo“ peresnika.
Table 5: Results of a 78 week active controlled study with two doses of dulaglutide in comparison to insulin glargine
Preglednica 5: Rezultati 78-tedenske študije, nadzorovane z aktivno primerjavo z dvema odmerkoma zdravila Trulicity v primerjavi z insulinom glarginom
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.
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.
The rates of documented symptomatic hypoglycaemia with Trulicity 1.5 mg and 0.75 mg, and insulin glargine were 31.06, 35.66, and 40.95 episodes/patient/year, respectively.
Stopnja dokumentirane simptomatske hipoglikemije za zdravilo Trulicity 1,5 mg in 0,75 mg ter insulin glargin je bila 31,06, 35,66 in 40,95 epizod/bolnika/leto.
Placebo once weekly and insulin glargine (n=150) ‡‡ p < 0.001 for superiority of dulaglutide compared to placebo, overall type I error controlled ** p < 0.001 dulaglutide treatment group compared to placebo
Placebo enkrat na teden in insulin glargin (n=150) ‡‡ p < 0,001, za superiorno učinkovitost dulaglutida v primerjavi s placebom, z nadzorovano skupno napako
Each syringe contains one weekly dose of Trulicity (0.75 mg or 1.5 mg).
Ena injekcijska brizga vsebuje en tedenski odmerek zdravila Trulicity (0,75 mg ali 1,5 mg).
Table 7: Results of a 24 week placebo controlled study of dulaglutide as add-on to SGLT2i therapy
Preglednica 7: Rezultati 24-tedenske študije, nadzorovane s placebom, z dulaglutidom kot dodatkom zdravljenju z zaviralcem SGLT2
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Trulicity 0.75 mg injection dulaglutide
IME ZDRAVILA IN POT(I) UPORABE Trulicity 0,75 mg injekcija dulaglutid subkutana uporaba
Small mean increases in heart rate of 2 to 4 beats per minute (bpm) and a 1.3% and 1.4 % incidence of sinus tachycardia, with a concomitant increase from baseline ≥ 15 bpm, were observed with dulaglutide 0.75mg and 1.5 mg, respectively.
Povečanje hitrosti srčnega utripa Pri zdravljenju z dulaglutidom 0,75mg in 1,5 mg so opazili majhna povprečna povečanja hitrosti srčnega utripa za 2 do 4 utripe na minuto (bpm) ter 1,3% oziroma 1,4 % incidenco sinusne tahikardije, s sočasnim povečanjem od izhodišča ≥ 15 bpm.
Placebo (n=60) ‡‡ p < 0.001 for superiority of dulaglutide compared to placebo, with overall type I error controlled ** p < 0.001 for dulaglutide treatment group compared to placebo
Placebo (n=60) ‡‡ p < 0,001 za superiorno učinkovitost dulaglutida v primerjavi s placebom, z nadzorovano skupno napako I. vrste.
Multi-pack: 12 (3 packs of 4) pre-filled syringes of 0.5 ml solution.
Večje pakiranje: 12 (3 pakiranja po 4) napolnjenih injekcijskih peresnikov z 0,5 ml raztopine.
Insulin glargine+ once daily (n=296) †† multiplicity adjusted 1-sided p-value < 0.025, for superiority of dulaglutide to insulin glargine,
Insulin glargin+ enkrat na dan (n=194) † Enostranska vrednost p< 0,025, za neinferiornost dulaglutida v primerjavi z insulinom glarginom.
Do not use this medicine if you notice that the pen is damaged, or the medicine is cloudy, discoloured or has particles in it.
Ne uporabljajte zdravila, če opazite, da je peresnik poškodovan ali če je zdravilo motno, obarvano ali če vsebuje delce.
Treatment with Trulicity 1.5 mg and 0.75 mg resulted in a superior reduction in HbA1c compared to sitagliptin at 52 weeks, accompanied by a significantly greater proportion of patients achieving HbA1c targets of < 7.0 % and ≤ 6.5 %.
Zdravljenje z zdravilom Trulicity 1,5 mg in 0, 75 mg je povzročilo superiorno zmanjšanje vrednosti HbA1c kot sitagliptin do 52. tedna, pri čemer je bistveno večji delež bolnikov dosegel ciljni vrednosti HbA1c < 7,0 % in ≤ 6,5 %.
Nausea, diarrhoea, vomiting†, abdominal pain†
Bolezni prebavil slabost, driska, bruhanje†,
Table 10: Results of a 52 week active controlled study with two doses of dulaglutide in comparison to insulin glargine
Preglednica 10: Rezultati 52-tedenske študije, nadzorovane z aktivno primerjavo z dvema odmerkoma zdravila Trulicity v primerjavi z insulinom glarginom
DISPOSAL OF PEN
napihnjenost ali bruhanje.
How to store Trulicity
Shranjevanje zdravila Trulicity
Do not use this medicine if you notice that the syringe is damaged, or the medicine is cloudy, discoloured or has particles in it.
Ne uporabljajte zdravila, če opazite, da je injekcijska brizga poškodovana ali če je zdravilo motno, obarvano ali če vsebuje delce.
Each syringe contains one weekly dose of Trulicity (1.5 mg).
Ena injekcijska brizga vsebuje en tedenski odmerek zdravila Trulicity (1.5 mg).
No dose adjustment is required for digoxin when administered with dulaglutide.
Pri aplikaciji skupaj z dulaglutidom prilagoditev odmerka digoksina ni potrebna.
One patient reported severe hypoglycaemia with Trulicity 0.75 mg in combination with SGLT2i therapy and none with Trulicity 1.5 mg or placebo.
Pri zdravilu Trulicity 0,75 mg v kombinaciji z zdravljenjem z zaviralcem SGLT2 je en bolnik je poročal o hudi hipoglikemiji, pri zdravilu Trulicity 1,5 mg ali placebu pa ni bilo nobenega takega primera.
The rates of documented symptomatic hypoglycaemia with Trulicity 1.5 mg and placebo were 0.90 and 0.04 episodes/patient/year, respectively.
Stopnji dokumentirane simptomatske hipoglikemije za zdravilo Trulicity 1,5 mg in placebo sta bili 0,90 oziroma 0,04 epizod/bolnika/leto.
Placebo (n=140) ‡‡ p < 0.001 for superiority of dulaglutide compared to placebo, with overall type I error controlled ** p < 0.001 for dulaglutide treatment group compared to placebo
Placebo (n=140) ‡‡ p < 0,001 za superiorno učinkovitost dulaglutida v primerjavi s placebom, z nadzorovano skupno napako
Table 8: Results of a 52 week active controlled study with two doses of dulaglutide in comparison to exenatide
Preglednica 8: Rezultati 52-tedenske študije, nadzorovane z aktivno primerjavo z dvema odmerkoma dulaglutida v primerjavi z eksenatidom
Packs of 2 and 4 pre-filled pens and multipack of 12 (3 packs of 4) pre-filled pens.
Pakiranja po 2 in 4 napolnjene peresnike in večje pakiranje, ki vsebuje 12 (3 pakiranja po 4) napolnjenih peresnikov.
No dose adjustment for warfarin is necessary when given together with dulaglutide.
Prilagajanje odmerka varfarina ob sočasnem dajanju z dulaglutidom ni potrebno.
Dulaglutide 1.5 mg once weekly (n=304)
Dulaglutid 1,5 mg enkrat na teden (n=304)
MARKETING AUTHORISATION NUMBER(S) EU/1/14/956/008
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/14/956/008
With Trulicity 1.5 mg, a significantly higher percentage of patients reached a target HbA1c of < 7.0 % and ≤ 6.5 % at 24 weeks compared to placebo.
Pri zdravljenju z zdravilom Trulicity 1,5 mg je v 24. tednu bistveno višji odstotek bolnikov dosegel ciljno vrednost HbA1c < 7,0 % in ≤ 6,5 %, v primerjavi s placebom.
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Trulicity 1.5 mg injection dulaglutide
IME ZDRAVILA IN POT(I) UPORABE Trulicity 1,5 mg injekcija dulaglutid subkutana uporaba
Multi-pack: 4 pre-filled syringes of 0.5 ml solution.
Večje pakiranje: 4 napolnjeni injekcijski peresniki z 0,5 ml raztopine.
• The syringe is a disposable, pre-filled delivery device.
• Napolnjena injekcijska brizga je napolnjen pripomoček za dostavo zdravila.
Pancreatic enzymes
Encimi trebušne slinavke
At 28 weeks, treatment with once weekly Trulicity 1.5 mg resulted in a statistically significant reduction in HbA1c compared to placebo and a significantly greater percentage of patients achieving HbA1c targets of < 7.0 % and ≤ 6.5 % (Table 9).
V 28. tednu je zdravljenje z zdravilom Trulicity 1,5 mg enkrat na teden povzročilo statistično pomembno zmanjšanje HbA1c v primerjavi s placebom in bistveno večji odstotek bolnikov je dosegel ciljne vrednosti HbA1c
Eli Lilly Italia S.p.A. Tel: + 39- 055 42571
Tel.: + 39- 055 42571
Each syringe contains one weekly dose of Trulicity (0.75 mg).
Ena injekcijska brizga vsebuje en tedenski odmerek zdravila Trulicity (0,75 mg).
The rate of documented symptomatic hypoglycaemia with Trulicity 1.5 mg and 0.75 mg, and metformin were 0.62, 0.15, and 0.09 episodes/patient/year, respectively.
Stopnja dokumentirane simptomatske hipoglikemije za zdravilo Trulicity 1,5 mg in 0,75 mg in metformin je bila 0,62, 0,15, in 0,09 epizod/bolnika/leto.
Packs of 4 pre-filled syringes and multipack of 12 (3 packs of 4) pre-filled syringes.
Pakiranja po 4 napolnjene injekcijske brizge in večje pakiranje, ki vsebuje 12 (3 pakiranja po 4) napolnjenih injekcijskih brizg.
1500-2000 mg/day (n=268) † multiplicity adjusted 1-sided p-value < 0.025, for noninferiority; †† multiplicity adjusted 1-sided p-value < 0.025, for superiority of dulaglutide to metformin, assessed for HbA1c only # p < 0.05, ## p < 0.001 dulaglutide treatment group compared to metformin
1500-2000 mg/dan (n=268) †† Enostranska vrednost p < 0,025, za neinferiorno učinkovitost dulaglutida v primerjavi z metforminom,
MARKETING AUTHORISATION NUMBER(S) EU/1/14/956/006 2 pre-filled pens
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/14/956/006 2 napolnjena peresnika EU/1/14//956/007 4 napolnjeni peresniki
Small mean increases from baseline in PR interval of 2 to 3 msec and a 1.5% and 2.4 % incidence of first-degree AV block were observed with dulaglutide 0.75 mg and 1.5 mg, respectively.
Pri zdravljenju z dulaglutidom 0,75 mg in 1,5 mg so opazili majhna povprečna povečanja v intervalu PR od izhodišča za 2 do 3 msec ter 1,5% oziroma 2,4 % incidenco atrioventrikularnega bloka prve stopnje.
Patients treated with dulaglutide should be advised of the potential risk of dehydration, particularly in relation to gastrointestinal side-effects and take precautions to avoid fluid depletion.
zlasti v povezavi z neželenimi učinki na prebavila, in jim naročiti, naj upoštevajo previdnostne ukrepe, da se izognejo pomanjkanju tekočine.
26 weeks Dulaglutide 1.5 mg once weekly (n=299) Liraglutide+ 1.8 mg daily (n=300) ‡ 1-sided p-value p < 0.001, for noninferiority of dulaglutide compared to liraglutide, assessed only for HbA1c.
24 tednov Dulaglutid 1,5 mg enkrat na teden (n=239) Placebo (n=60) ‡‡ p < 0,001, za superiorno učinkovitost dulaglutida v primerjavi s placebom, z nadzorovano skupno napako I. vrste.
Table 2: Results of a 52 week active controlled monotherapy study with two doses of dulaglutide in comparison to metformin
Preglednica 2: Rezultati 52-tedenske študije monoterapije, nadzorovane s placebom in aktivno primerjavo z dvema odmerkoma zdravila Trulicity v primerjavi z metforminom
assessed for HbA1c only # p < 0.05, ## p < 0.001 dulaglutide treatment group compared to insulin glargine + Insulin glargine doses were adjusted utilizing an algorithm with a fasting plasma glucose target of
# p < 0,05, ## p < 0,001 skupina, zdravljena z dulaglutidom v primerjavi z insulinom glarginom.