FrancophonIA/ELRC3.0 huggingface dataset:
English: 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.
Slovenian: 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.
English: 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
Slovenian: Placebo enkrat na teden in insulin glargin (n=150) ‡‡ p < 0,001, za superiorno učinkovitost dulaglutida v primerjavi s placebom, z nadzorovano skupno napako
English: Each syringe contains one weekly dose of Trulicity (0.75 mg or 1.5 mg).
Slovenian: Ena injekcijska brizga vsebuje en tedenski odmerek zdravila Trulicity (0,75 mg ali 1,5 mg).
English: Table 7: Results of a 24 week placebo controlled study of dulaglutide as add-on to SGLT2i therapy
Slovenian: Preglednica 7: Rezultati 24-tedenske študije, nadzorovane s placebom, z dulaglutidom kot dodatkom zdravljenju z zaviralcem SGLT2
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Trulicity 0.75 mg injection dulaglutide
Slovenian: IME ZDRAVILA IN POT(I) UPORABE Trulicity 0,75 mg injekcija dulaglutid subkutana uporaba
English: 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.
Slovenian: 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.
English: 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
Slovenian: Placebo (n=60) ‡‡ p < 0,001 za superiorno učinkovitost dulaglutida v primerjavi s placebom, z nadzorovano skupno napako I. vrste.
English: Multi-pack: 12 (3 packs of 4) pre-filled syringes of 0.5 ml solution.
Slovenian: Večje pakiranje: 12 (3 pakiranja po 4) napolnjenih injekcijskih peresnikov z 0,5 ml raztopine.
English: Insulin glargine+ once daily (n=296) †† multiplicity adjusted 1-sided p-value < 0.025, for superiority of dulaglutide to insulin glargine,
Slovenian: Insulin glargin+ enkrat na dan (n=194) † Enostranska vrednost p< 0,025, za neinferiornost dulaglutida v primerjavi z insulinom glarginom.
English: Do not use this medicine if you notice that the pen is damaged, or the medicine is cloudy, discoloured or has particles in it.
Slovenian: Ne uporabljajte zdravila, če opazite, da je peresnik poškodovan ali če je zdravilo motno, obarvano ali če vsebuje delce.
English: 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 %.
Slovenian: 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 %.
English: Nausea, diarrhoea, vomiting†, abdominal pain†
Slovenian: Bolezni prebavil slabost, driska, bruhanje†,
English: Table 10: Results of a 52 week active controlled study with two doses of dulaglutide in comparison to insulin glargine
Slovenian: Preglednica 10: Rezultati 52-tedenske študije, nadzorovane z aktivno primerjavo z dvema odmerkoma zdravila Trulicity v primerjavi z insulinom glarginom
English: DISPOSAL OF PEN
Slovenian: napihnjenost ali bruhanje.
English: How to store Trulicity
Slovenian: Shranjevanje zdravila Trulicity
English: Do not use this medicine if you notice that the syringe is damaged, or the medicine is cloudy, discoloured or has particles in it.
Slovenian: Ne uporabljajte zdravila, če opazite, da je injekcijska brizga poškodovana ali če je zdravilo motno, obarvano ali če vsebuje delce.
English: Each syringe contains one weekly dose of Trulicity (1.5 mg).
Slovenian: Ena injekcijska brizga vsebuje en tedenski odmerek zdravila Trulicity (1.5 mg).
English: No dose adjustment is required for digoxin when administered with dulaglutide.
Slovenian: Pri aplikaciji skupaj z dulaglutidom prilagoditev odmerka digoksina ni potrebna.
English: One patient reported severe hypoglycaemia with Trulicity 0.75 mg in combination with SGLT2i therapy and none with Trulicity 1.5 mg or placebo.
Slovenian: 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.
English: The rates of documented symptomatic hypoglycaemia with Trulicity 1.5 mg and placebo were 0.90 and 0.04 episodes/patient/year, respectively.
Slovenian: Stopnji dokumentirane simptomatske hipoglikemije za zdravilo Trulicity 1,5 mg in placebo sta bili 0,90 oziroma 0,04 epizod/bolnika/leto.
English: 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
Slovenian: Placebo (n=140) ‡‡ p < 0,001 za superiorno učinkovitost dulaglutida v primerjavi s placebom, z nadzorovano skupno napako
English: Table 8: Results of a 52 week active controlled study with two doses of dulaglutide in comparison to exenatide
Slovenian: Preglednica 8: Rezultati 52-tedenske študije, nadzorovane z aktivno primerjavo z dvema odmerkoma dulaglutida v primerjavi z eksenatidom
English: Packs of 2 and 4 pre-filled pens and multipack of 12 (3 packs of 4) pre-filled pens.
Slovenian: Pakiranja po 2 in 4 napolnjene peresnike in večje pakiranje, ki vsebuje 12 (3 pakiranja po 4) napolnjenih peresnikov.
English: Immunogenicity
Slovenian: Monoterapija
English: No dose adjustment for warfarin is necessary when given together with dulaglutide.
Slovenian: Prilagajanje odmerka varfarina ob sočasnem dajanju z dulaglutidom ni potrebno.
English: Dulaglutide 1.5 mg once weekly (n=304)
Slovenian: Dulaglutid 1,5 mg enkrat na teden (n=304)
English: MARKETING AUTHORISATION NUMBER(S) EU/1/14/956/008
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/14/956/008
English: 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.
Slovenian: 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.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Trulicity 1.5 mg injection dulaglutide
Slovenian: IME ZDRAVILA IN POT(I) UPORABE Trulicity 1,5 mg injekcija dulaglutid subkutana uporaba
English: Multi-pack: 4 pre-filled syringes of 0.5 ml solution.
Slovenian: Večje pakiranje: 4 napolnjeni injekcijski peresniki z 0,5 ml raztopine.
English: • The syringe is a disposable, pre-filled delivery device.
Slovenian: • Napolnjena injekcijska brizga je napolnjen pripomoček za dostavo zdravila.
English: Pancreatic enzymes
Slovenian: Encimi trebušne slinavke
English: 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).
Slovenian: 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
English: Eli Lilly Italia S.p.A. Tel: + 39- 055 42571
Slovenian: Tel.: + 39- 055 42571
English: Each syringe contains one weekly dose of Trulicity (0.75 mg).
Slovenian: Ena injekcijska brizga vsebuje en tedenski odmerek zdravila Trulicity (0,75 mg).
English: 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.
Slovenian: 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.
English: Packs of 4 pre-filled syringes and multipack of 12 (3 packs of 4) pre-filled syringes.
Slovenian: Pakiranja po 4 napolnjene injekcijske brizge in večje pakiranje, ki vsebuje 12 (3 pakiranja po 4) napolnjenih injekcijskih brizg.
English: 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
Slovenian: 1500-2000 mg/dan (n=268) †† Enostranska vrednost p < 0,025, za neinferiorno učinkovitost dulaglutida v primerjavi z metforminom,
English: MARKETING AUTHORISATION NUMBER(S) EU/1/14/956/006 2 pre-filled pens
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/14/956/006 2 napolnjena peresnika EU/1/14//956/007 4 napolnjeni peresniki
English: INJECT
Slovenian: Dojenje
English: 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.
Slovenian: 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.
English: 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.
Slovenian: zlasti v povezavi z neželenimi učinki na prebavila, in jim naročiti, naj upoštevajo previdnostne ukrepe, da se izognejo pomanjkanju tekočine.
English: 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.
Slovenian: 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.
English: Table 2: Results of a 52 week active controlled monotherapy study with two doses of dulaglutide in comparison to metformin
Slovenian: Preglednica 2: Rezultati 52-tedenske študije monoterapije, nadzorovane s placebom in aktivno primerjavo z dvema odmerkoma zdravila Trulicity v primerjavi z metforminom
English: 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
Slovenian: # p < 0,05, ## p < 0,001 skupina, zdravljena z dulaglutidom v primerjavi z insulinom glarginom.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/14/956/001 2 pre-filled pens
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/14/956/001 2 napolnjena peresnika EU/1/14/956/002 4 napolnjeni peresniki
English: 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.
Slovenian: 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 %.
English: 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.
Slovenian: 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.
English: It is not known if dulaglutide could harm your unborn child. Women who could become pregnant should use contraception during treatment with dulagutide.
Slovenian: Ni znano, ali lahko dulaglutid škoduje vašemu nerojenemu otroku.
English: 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.
Slovenian: 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.
English: Name and address of the manufacturer(s) responsible for batch release Eli Lilly Italia S.p.A.
Slovenian: Ime in naslov proizvajalca (proizvajalcev), odgovornega (odgovornih) za sproščanje serij
English: Pack sizes of 4 or multipacks of 12 (3 packs of 4) pre-filled syringes.
Slovenian: Pakiranja po 4 ali večja pakiranja po 12 (3 pakiranja po 4) napolnjenih injekcijskih brizg.
English: 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.
Slovenian: 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.
English: Dulaglutide 1.5 mg once weekly (n=192)
Slovenian: Dulaglutid 1,5 mg enkrat na teden (n=192)
English: Dulaglutide 1.5 mg once weekly (n=142)
Slovenian: Dulaglutid 1,5 mg enkrat na teden (n=142)
English: the syringe.
Slovenian: injekcijsko brizgo.
English: 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.
Slovenian: 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.
English: Each pre-filled syringe contains 0.5 ml of solution.
Slovenian: Vsaka napolnjena injekcijska brizga vsebuje 0,5 ml raztopine.
English: SC
Slovenian: V
English: Each pen contains one weekly dose of Trulicity (0.75 mg).
Slovenian: En peresnik vsebuje en tedenski odmerek zdravila Trulicity (0,75 mg).
English: Dulaglutide 1.5 mg once weekly (n=269)
Slovenian: Dulaglutid 1,5 mg enkrat na teden (n=269)
English: Instructions for use Trulicity 1.5 mg solution for injection in pre-filled syringe dulaglutide
Slovenian: Navodila za uporabo Trulicity 1,5 mg raztopina za injiciranje v napolnjenem injekcijskem peresniku dulaglutid
English: Dulaglutide 0.75 mg once weekly (n=190)
Slovenian: Dulaglutid 0,75 mg enkrat na teden (n=190)
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING INTERMEDIATE CARTON (without Blue Box) component of a multipack - PRE-FILLED SYRINGE
Slovenian: ZUNANJA ŠKATLA (brez modrega okenca), sestavni del pakiranja - VEČJE PAKIRANJENAPOLNJEN INJEKCIJSKI PERESNIK
English: DISPOSAL OF SYRINGE
Slovenian: ODLAGANJE INJEKCIJSKE BRIZGE
English: - Trulicity 0.75 mg: Each pre-filled syringe contains 0.75 mg of dulaglutide in 0.5 ml solution.
Slovenian: - Trulicity 0,75 mg: Ena napolnjena injekcijska brizga vsebuje 0,75 mg dulaglutida v 0,5 ml raztopine.
English: Trulicity 1.5 mg solution for injection Each pre-filled syringe contains 1.5 mg of dulaglutide* in 0.5 ml solution.
Slovenian: Trulicity 1,5 mg raztopina za injiciranje Ena napolnjena injekcijska brizga vsebuje 1,5 mg dulaglutida* v 0,5 ml raztopine.
English: Instructions for use Trulicity 0.75 mg solution for injection in pre-filled syringe dulaglutide
Slovenian: Navodila za uporabo Trulicity 0,75 mg raztopina za injiciranje v napolnjeni injekcijski brizgi dulaglutid
English: Dulaglutide 0.75 mg once weekly (n=293)
Slovenian: Dulaglutid 0,75 mg enkrat na teden (n=293)
English: Name and address of the manufacturers of the biological active substance Eli Lilly Kinsale Limited
Slovenian: Eli Lilly Kinsale Limited Dunderrow
English: No dose adjustment for metformin IR is recommended when given with dulaglutide.
Slovenian: Ob sočasnem dajanju metformina IR z dulaglutidom prilagajanje odmerka metformina IR ni priporočeno.
English: Eli Lilly Nederland B.V. Tel: + 31-(0) 30 60 25 800
Slovenian: Tel.: + 31-(0) 30 60 25 800
English: Dulaglutide 0.75 mg once weekly (n=141)
Slovenian: 24 tednov Dulaglutid 0,75 mg enkrat na teden (n=141)
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Trulicity 0.75 mg solution for injection in pre-filled pen dulaglutide
Slovenian: IME ZDRAVILA IN POT(I) UPORABE Trulicity 0,75 mg raztopina za injiciranje v napolnjenem injekcijskem peresniku dulaglutid subkutana uporaba
English: MARKETING AUTHORISATION NUMBER(S) EU/1/14/956/010
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/14/956/010 13.
English: Dulaglutide 0.75 mg once weekly (n=302)
Slovenian: Dulaglutid 0,75 mg enkrat na teden (n=302)
English: Pack sizes of 2, 4 or multipacks of 12 (3 packs of 4) pre-filled pens.
Slovenian: Pakiranja po 2, 4 ali večja pakiranja po 12 (3 pakiranja po 4) napolnjenih injekcijskih peresnikov.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/14/956/003
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/14/956/003
English: 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.
Slovenian: Pogostnost dokumentirane simptomatske hipoglikemije ob uporabi dulaglutida 1,5 mg s samo sulfonilsečnino je bila 11,3 %, stopnja pa 0,90
English: 1 UNCAP
Slovenian: 1 ODPRITE
English: 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.
Slovenian: Trulicity 0,75 mg raztopina za injiciranje Ena napolnjena injekcijska brizga vsebuje 0,75 mg dulaglutida* v 0,5 ml raztopine.
English: Dulaglutide 0.75 mg once weekly (n=272)
Slovenian: Dulaglutid 0.75 mg enkrat na teden (n=272)
English: No dose adjustment for oral contraceptives is required when given together with dulaglutide.
Slovenian: Pri aplikaciji skupaj z dulaglutidom prilagoditev odmerka peroralnih kontraceptivov ni potrebna.
English: 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.
Slovenian: 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 %
English: - Trulicity 1.5 mg: Each pre-filled syringe contains 1.5 mg of dulaglutide in 0.5 ml solution.
Slovenian: Trulicity 1,5 mg: Ena napolnjena injekcijska brizga vsebuje 1,5 mg dulaglutida v 0,5 ml raztopine.
English: 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 %).
Slovenian: 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.
English: Store in the original package in order to protect from light.
Slovenian: Shranjujte v originalni ovojnini, da zagotovite zaščito pred svetlobo.
English: Dulaglutide 0.75 mg once weekly (n=280)
Slovenian: Dulaglutid 0,75 mg enkrat na teden (n=280)
English: Dulaglutide 0.75 mg once weekly (n=270)
Slovenian: Dulaglutid 0,75 mg enkrat na teden (n=270)
English: Each syringe delivers one dose only.
Slovenian: Vsaka injekcijska brizga je namenjena le za enkratno uporabo.
English: ABOUT TRULICITY PRE-FILLED PEN
Slovenian: O NAPOLNJENEM INJEKCIJSKEM PERESNIKU TRULICITY
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Trulicity 1.5 mg solution for injection in pre-filled pen dulaglutide
Slovenian: IME ZDRAVILA IN POT(I) UPORABE Trulicity 1,5 mg raztopina za injiciranje v napolnjenem injekcijskem peresniku dulaglutid subkutana uporaba
English: Remove the pen from your skin.
Slovenian: • Umaknite peresnik s kože.
English: 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.
Slovenian: 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.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON (with Blue Box) multipack - PRE-FILLED SYRINGE
Slovenian: ZUNANJA ŠKATLA (z modrim okencem) VEČJE PAKIRANJE - NAPOLNJENA INJEKCIJSKA BRIZGA
English: Instructions for use Trulicity 0.75 mg solution for injection in pre-filled pen dulaglutide
Slovenian: Navodila za uporabo Trulicity 0,75 mg raztopina za injiciranje v napolnjenem injekcijskem peresniku dulaglutid
English: assessed for HbA1c only ** p < 0.001 dulaglutide treatment group compared to placebo ## p < 0.001 dulaglutide treatment group compared to sitagliptin
Slovenian: * p < 0.05, ** p < 0,001 skupina, zdravljena z dulaglutidom v primerjavi s placebom.
English: Dulaglutide 1.5 mg once weekly (n=295)
Slovenian: Dulaglutid 1,5 mg enkrat na teden (n=299)
English: Warnings and precautions Talk to your doctor, pharmacist or nurse before using Trulicity if: - you are on dialysis as this medicine is not recommended.
Slovenian: Opozorila in previdnostni ukrepi Pred začetkom uporabe zdravila Trulicity se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro,
English: Trulicity 0.75 mg solution for injection in pre-filled syringe Trulicity 1.5 mg solution for injection in pre-filled syringe dulaglutide
Slovenian: Trulicity 0,75 mg raztopina za injiciranje v napolnjenem injekcijskem peresniku Trulicity 1,5 mg raztopina za injiciranje v napolnjenem injekcijskem peresniku
English: Sitagliptin exposure was unaffected when coadministered with a single dose of dulaglutide.
Slovenian: Po sočasnem dajanju sitagliptina in enkratnega odmerka dulaglutida je ostala izpostavljenost sitagliptinu nespremenjena.
English: BACK
Slovenian: spredaj zadaj
English: You may want to mark your calendar to remind you when to inject your next dose.
Slovenian: Da se boste spomnili, kdaj morate vzeti naslednji odmerek, si dan označite na koledarju.
English: Tabulated list of adverse reactions
Slovenian: V preglednici predstavljeni neželeni učinki
English: Dulaglutide 1.5 mg once weekly (n=273)
Slovenian: 52 tednov Dulaglutid 1,5 mg enkrat na teden (n=273)
English: What Trulicity contains The active substance is dulaglutide.
Slovenian: Zdravilna učinkovina je dulaglutid.
English: INSERT 3.
Slovenian: 2 VSTAVITE
English: Dulaglutide 1.5 mg once weekly (n=239)
Slovenian: 24 tednov Dulaglutid 1,5 mg enkrat na teden (n=239)
English: Dulaglutide 1.5 mg once weekly (n=279)
Slovenian: 26 tednov Dulaglutid 1,5 mg enkrat na teden (n=279)
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON (with Blue Box) - multipack - PRE-FILLED PEN
Slovenian: ZUNANJA ŠKATLA (z modrim okencem) - VEČJE PAKIRANJE - NAPOLNJENA INJEKCIJSKA BRIZGA
English: Children and adolescents
Slovenian: POGLEDA OTROK
English: Other things you should know
Slovenian: Druge stvari, ki jih morate vedeti
English: • Take 1 hour before or 2 hours after a meal.
Slovenian: • Vzemite 1 uro pred ali 2 uri po obroku.
English: The basis for their contributions to resistance, however, is complex.
Slovenian: Vendar pa je osnova za njihov prispevek k rezistenci kompleksna.
English: Date of first authorisation: 04 October 1996 Date of latest renewal: 18 July 2011
Slovenian: Datum prve odobritve: 04. oktober 1996 Datum zadnjega podaljšanja: 18. julij 2011