natgillin/translations-raw huggingface dataset:
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.
MARKETING AUTHORISATION NUMBER(S) EU/1/14/956/001 2 pre-filled pens 
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/14/956/001 2 napolnjena peresnika EU/1/14/956/002 4 napolnjeni peresniki
Treatment with Trulicity 1.5 mg resulted in similar lowering of HbA1c and patients achieving HbA1c targets of < 7.0 % and ≤ 6.5 % compared to liraglutide. 
Zdravljenje z zdravilom Trulicity 1,5 mg in 0, 75 mg je povzročilo podobno zmanjšanje vrednosti HbA1c kot pri liraglutidu, bolniki pa so dosegli ciljne vrednosti HbA1c < 7,0 % in ≤ 6,5 %.
The rates of documented symptomatic hypoglycaemia with Trulicity 0.75 mg, Trulicity 1.5 mg, and placebo were 0.15, 0.16 and 0.12 episodes/patient/year, respectively. 
Stopnje dokumentirane simptomatske hipoglikemije za zdravilo Trulicity 0,75 mg, zdravilo Trulicity 1,5 mg in placebo so bile 0,15, 0,16 oziroma 0,12 epizode/bolnika/leto.
It is not known if dulaglutide could harm your unborn child. Women who could become pregnant should use contraception during treatment with dulagutide. 
Ni znano, ali lahko dulaglutid škoduje vašemu nerojenemu otroku.
With both Trulicity 0.75 mg and 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 0,75 mg ali 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 and address of the manufacturer(s) responsible for batch release Eli Lilly Italia S.p.A. 
Ime in naslov proizvajalca (proizvajalcev), odgovornega (odgovornih) za sproščanje serij
Pack sizes of 4 or multipacks of 12 (3 packs of 4) pre-filled syringes. 
Pakiranja po 4 ali večja pakiranja po 12 (3 pakiranja po 4) napolnjenih injekcijskih brizg.
The rates of documented symptomatic hypoglycaemia with Trulicity 1.5 mg and 0.75 mg, and exenatide twice daily were 0.19, 0.14, and 0.75 episodes/patient/year, respectively. 
Stopnja dokumentirane simptomatske hipoglikemije za zdravilo Trulicity 1,5 mg in 0,75 mg ter eksenatid dvakrat na dan je bila 0,19, 0,14, in 0,75 epizod/bolnika/leto.
Dulaglutide 1.5 mg once weekly (n=192) 
Dulaglutid 1,5 mg enkrat na teden (n=192)
Dulaglutide 1.5 mg once weekly (n=142) 
Dulaglutid 1,5 mg enkrat na teden (n=142)
the syringe. 
injekcijsko brizgo.
The rates of documented symptomatic hypoglycaemia with Trulicity 1.5 mg and 0.75 mg, and sitagliptin were 0.19, 0.18, and 0.17 episodes/patient/year, respectively. 
Stopnja dokumentirane simptomatske hipoglikemije za zdravilo Trulicity 1,5 mg in 0,75 mg in sitagliptin je bila 0,19, 0,18, in 0,17 epizod/bolnika/leto.
Each pre-filled syringe contains 0.5 ml of solution. 
Vsaka napolnjena injekcijska brizga vsebuje 0,5 ml raztopine.
SC 
V
Each pen contains one weekly dose of Trulicity (0.75 mg). 
En peresnik vsebuje en tedenski odmerek zdravila Trulicity (0,75 mg).
Dulaglutide 1.5 mg once weekly (n=269) 
Dulaglutid 1,5 mg enkrat na teden (n=269)
Instructions for use Trulicity 1.5 mg solution for injection in pre-filled syringe dulaglutide 
Navodila za uporabo Trulicity 1,5 mg raztopina za injiciranje v napolnjenem injekcijskem peresniku dulaglutid
Dulaglutide 0.75 mg once weekly (n=190) 
Dulaglutid 0,75 mg enkrat na teden (n=190)
PARTICULARS TO APPEAR ON THE OUTER PACKAGING INTERMEDIATE CARTON (without Blue Box) component of a multipack - PRE-FILLED SYRINGE 
ZUNANJA ŠKATLA (brez modrega okenca), sestavni del pakiranja - VEČJE PAKIRANJENAPOLNJEN INJEKCIJSKI PERESNIK
DISPOSAL OF SYRINGE 
ODLAGANJE INJEKCIJSKE BRIZGE
- Trulicity 0.75 mg: Each pre-filled syringe contains 0.75 mg of dulaglutide in 0.5 ml solution. 
- Trulicity 0,75 mg: Ena napolnjena injekcijska brizga vsebuje 0,75 mg dulaglutida v 0,5 ml raztopine.
Trulicity 1.5 mg solution for injection Each pre-filled syringe contains 1.5 mg of dulaglutide* in 0.5 ml solution. 
Trulicity 1,5 mg raztopina za injiciranje Ena napolnjena injekcijska brizga vsebuje 1,5 mg dulaglutida* v 0,5 ml raztopine.
Instructions for use Trulicity 0.75 mg solution for injection in pre-filled syringe dulaglutide 
Navodila za uporabo Trulicity 0,75 mg raztopina za injiciranje v napolnjeni injekcijski brizgi dulaglutid
Dulaglutide 0.75 mg once weekly (n=293) 
Dulaglutid 0,75 mg enkrat na teden (n=293)
No dose adjustment for metformin IR is recommended when given with dulaglutide. 
Ob sočasnem dajanju metformina IR z dulaglutidom prilagajanje odmerka metformina IR ni priporočeno.
Eli Lilly Nederland B.V. Tel: + 31-(0) 30 60 25 800 
Tel.: + 31-(0) 30 60 25 800
Dulaglutide 0.75 mg once weekly (n=141) 
24 tednov Dulaglutid 0,75 mg enkrat na teden (n=141)
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Trulicity 0.75 mg solution for injection in pre-filled pen dulaglutide 
IME ZDRAVILA IN POT(I) UPORABE Trulicity 0,75 mg raztopina za injiciranje v napolnjenem injekcijskem peresniku dulaglutid subkutana uporaba
MARKETING AUTHORISATION NUMBER(S) EU/1/14/956/010 
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/14/956/010 13.
Dulaglutide 0.75 mg once weekly (n=302) 
Dulaglutid 0,75 mg enkrat na teden (n=302)
Pack sizes of 2, 4 or multipacks of 12 (3 packs of 4) pre-filled pens. 
Pakiranja po 2, 4 ali večja pakiranja po 12 (3 pakiranja po 4) napolnjenih injekcijskih peresnikov.
MARKETING AUTHORISATION NUMBER(S) EU/1/14/956/003 
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/14/956/003
The incidence of documented symptomatic hypoglycaemia when dulaglutide 1.5 mg was used with sulphonylurea alone was 11.3% and the rate was 0.90 events/patient/year, and there were no episodes of severe hypoglycaemia. 
Pogostnost dokumentirane simptomatske hipoglikemije ob uporabi dulaglutida 1,5 mg s samo sulfonilsečnino je bila 11,3 %, stopnja pa 0,90
1 UNCAP 
1 ODPRITE
QUALITATIVE AND QUANTITATIVE COMPOSITION Trulicity 0.75 mg solution for injection Each pre-filled syringe contains 0.75 mg of dulaglutide* in 0.5 ml solution. 
Trulicity 0,75 mg raztopina za injiciranje Ena napolnjena injekcijska brizga vsebuje 0,75 mg dulaglutida* v 0,5 ml raztopine.
Dulaglutide 0.75 mg once weekly (n=272) 
Dulaglutid 0.75 mg enkrat na teden (n=272)
No dose adjustment for oral contraceptives is required when given together with dulaglutide. 
Pri aplikaciji skupaj z dulaglutidom prilagoditev odmerka peroralnih kontraceptivov ni potrebna.
Trulicity 1.5 mg and 0.75 mg were superior to metformin (1500-2000 mg/day) in the reduction in HbA1c and a significantly greater proportion of patients reached an HbA1c target of < 7.0 % and ≤ 6.5 % with Trulicity 1.5 mg and Trulicity 0.75 mg compared to metformin at 26 weeks. 
Odmerka zdravila Trulicity 1,5 mg in 0,75 mg sta bila superiorna od metformina (1500-2000 mg/dan) pri zmanjševanju vrednosti HbA1c in bistveno večji delež bolnikov je dosegel ciljno vrednost HbA1c < 7,0 %
- Trulicity 1.5 mg: Each pre-filled syringe contains 1.5 mg of dulaglutide in 0.5 ml solution. 
Trulicity 1,5 mg: Ena napolnjena injekcijska brizga vsebuje 1,5 mg dulaglutida v 0,5 ml raztopine.
Cumulative reporting of gastrointestinal events up to 104 weeks with dulaglutide 0.75mg and 1.5 mg, respectively, included nausea (12.9% and 21.2 %), diarrhoea (10.7% and 13.7 %) and vomiting (6.9% and 11.5 %). 
0,75 mg in 1,5 mg je vključevalo slabost (12,9 % oziroma 21,2 %), drisko (10,7 % oziroma 13,7 %) in bruhanje (6,9% oziroma 11,5 %).Ti učinki so bili po jakosti običajno blagi ali zmerni, vrh pa so dosegli v prvih 2 tednih zdravljenja in postopoma upadali v naslednjih 4 tednih, nato pa ostali relativno stalni.
Store in the original package in order to protect from light. 
Shranjujte v originalni ovojnini, da zagotovite zaščito pred svetlobo.
Dulaglutide 0.75 mg once weekly (n=280) 
Dulaglutid 0,75 mg enkrat na teden (n=280)
Dulaglutide 0.75 mg once weekly (n=270) 
Dulaglutid 0,75 mg enkrat na teden (n=270)
Each syringe delivers one dose only. 
Vsaka injekcijska brizga je namenjena le za enkratno uporabo.
ABOUT TRULICITY PRE-FILLED PEN 
O NAPOLNJENEM INJEKCIJSKEM PERESNIKU TRULICITY
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Trulicity 1.5 mg solution for injection in pre-filled pen dulaglutide 
IME ZDRAVILA IN POT(I) UPORABE Trulicity 1,5 mg raztopina za injiciranje v napolnjenem injekcijskem peresniku dulaglutid subkutana uporaba
Remove the pen from your skin. 
• Umaknite peresnik s kože.
At 52 weeks, Trulicity 1.5 mg demonstrated superior lowering in HbA1c to insulin glargine which was maintained at 78 weeks; whereas lowering in HbA1c with Trulicity 0.75 mg was non-inferior to insulin glargine. 
Po 52 tednih je zdravilo Trulicity 1,5 mg dokazalo superiorno znižanje HbA1c kot insulin glargin; ta učinek se je ohranil tudi po 78 tednih.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON (with Blue Box) multipack - PRE-FILLED SYRINGE 
ZUNANJA ŠKATLA (z modrim okencem) VEČJE PAKIRANJE - NAPOLNJENA INJEKCIJSKA BRIZGA
Instructions for use Trulicity 0.75 mg solution for injection in pre-filled pen dulaglutide 
Navodila za uporabo Trulicity 0,75 mg raztopina za injiciranje v napolnjenem injekcijskem peresniku dulaglutid
assessed for HbA1c only ** p < 0.001 dulaglutide treatment group compared to placebo ## p < 0.001 dulaglutide treatment group compared to sitagliptin 
* p < 0.05, ** p < 0,001 skupina, zdravljena z dulaglutidom v primerjavi s placebom.
Dulaglutide 1.5 mg once weekly (n=295) 
Dulaglutid 1,5 mg enkrat na teden (n=299)
Warnings and precautions Talk to your doctor, pharmacist or nurse before using Trulicity if: - you are on dialysis as this medicine is not recommended. 
Opozorila in previdnostni ukrepi Pred začetkom uporabe zdravila Trulicity se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro,
Trulicity 0.75 mg solution for injection in pre-filled syringe Trulicity 1.5 mg solution for injection in pre-filled syringe dulaglutide 
Trulicity 0,75 mg raztopina za injiciranje v napolnjenem injekcijskem peresniku Trulicity 1,5 mg raztopina za injiciranje v napolnjenem injekcijskem peresniku
Sitagliptin exposure was unaffected when coadministered with a single dose of dulaglutide. 
Po sočasnem dajanju sitagliptina in enkratnega odmerka dulaglutida je ostala izpostavljenost sitagliptinu nespremenjena.
BACK 
spredaj zadaj
You may want to mark your calendar to remind you when to inject your next dose. 
Da se boste spomnili, kdaj morate vzeti naslednji odmerek, si dan označite na koledarju.
Tabulated list of adverse reactions 
V preglednici predstavljeni neželeni učinki
Dulaglutide 1.5 mg once weekly (n=273) 
52 tednov Dulaglutid 1,5 mg enkrat na teden (n=273)
What Trulicity contains The active substance is dulaglutide. 
Zdravilna učinkovina je dulaglutid.
INSERT 3. 
2 VSTAVITE
Dulaglutide 1.5 mg once weekly (n=239) 
24 tednov Dulaglutid 1,5 mg enkrat na teden (n=239)
Dulaglutide 1.5 mg once weekly (n=279) 
26 tednov Dulaglutid 1,5 mg enkrat na teden (n=279)
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON (with Blue Box) - multipack - PRE-FILLED PEN 
ZUNANJA ŠKATLA (z modrim okencem) - VEČJE PAKIRANJE - NAPOLNJENA INJEKCIJSKA BRIZGA
Children and adolescents 
POGLEDA OTROK
Other things you should know 
Druge stvari, ki jih morate vedeti
• Take 1 hour before or 2 hours after a meal. 
• Vzemite 1 uro pred ali 2 uri po obroku.
The basis for their contributions to resistance, however, is complex. 
Vendar pa je osnova za njihov prispevek k rezistenci kompleksna.
Date of first authorisation: 04 October 1996 Date of latest renewal: 18 July 2011 
Datum prve odobritve: 04. oktober 1996 Datum zadnjega podaljšanja: 18. julij 2011
It is not known how often this may happen (cannot be estimated from the available data), but the reaction can sometimes be severe and include shock 
Ni znano, kako pogosto se to lahko zgodi (ni mogoče oceniti iz razpoložljivih podatkov), vendar je reakcija včasih lahko huda in vključuje tudi šok.
It is however especially important that you: 
Še posebej je pomembno, da:
Other substitutions were observed less frequently. 
Ostale substitucije so opazili redkeje.
In some patients additional factor VIII was given. 
Nekateri bolniki so dodatno dobivali faktor VIII.
This may be because the body is able to start fighting infections again. 
To je lahko posledica tega, da se telo lahko spet začne boriti proti okužbam.
CD4 cells are an important part of your immune system. 
CD4 celice so pomemben del vašega imunskega sistema.