natgillin/translations-raw huggingface dataset:
Nocturia, urinary tract infection 
Bolezni sečil nikturija, okužba sečil
• Agitated 
• agitacija,
Central nervous symptoms such as vertigo, walking instability and hemi-paresis have been observed with accidental Exalief overdose. 
Pri nenamernem prevelikem odmerjanju zdravila Exalief so opazili simptome, povezane z osrednjim živčevjem, kot so vrtoglavica, nestabilnost pri hoji in hemipareza.
Asthenia, malaise, chills, oedema peripheral, adverse drug reaction, peripheral coldness 
Splošne težave in spremembe na mestu aplikacije motnje pri hoji sstenija, slabotnost, mrzlica, periferni edem, neželene reakcije na zdravilo, hladne okončine
MARKETING AUTHORISATION NUMBER(S) EU/1/09/520/020 
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/09/520/020
MARKETING AUTHORISATION NUMBER(S) EU/1/09/520/011 
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/09/520/011
No second or higher degree AV block was seen in eslicarbazepine acetate treated patients. 
Pri bolnikih, ki so prejemali eslikarbazepinacetat, AV-bloka druge ali večje stopnje niso opazili.
Please talk to your doctor if you are unsure about the dose you should be taking. 
Če ste negotovi glede odmerka, ki bi ga morali prejemati, se posvetujte z zdravnikom.
• Feeling sick or vomiting 
• splošno slabo počutje ali mrzlica,
The tablets have ‘ESL 400'engraved on one side and are scored on the other side. 
Na eni strani je vtisnjen napis ‘ESL 400', na drugi pa je zareza.
Reproductive system and breast disorders 
Motnje reprodukcije in dojk neredna menstruacija
• Headache 
• driska,
STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 800 mg of eslicarbazepine acetate. 
NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Ena tableta vsebuje 800 mg eslikarbazepinacetata.
STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 400 mg of eslicarbazepine acetate. 
NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Ena tableta vsebuje 400 mg eslikarbazepinacetata.
STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 600 mg of eslicarbazepine acetate. 
NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Ena tableta vsebuje 600 mg eslikarbazepinacetata.
Folic acid supplementation is recommended before and during pregnancy. 
Pred nosečnostjo in med njo je priporočljivo dajati nadomestke folne kisline.
After the Commission Decision the Member State Competent Authorities will update the product information as required 
Po odločbi komisije bo pristojen organ države članice v skladu z odločbo po potrebi posodobil informacije o izdelku.
Pharma Gyógyszerkereskedel mi Kft. 
C. P. Pharma Gyógyszerkereskedel mi Kft.
4.8 Undesirable effects {To be completed nationally}. 
4.8 Neželeni učinki {Izpolni država članica}.
ANNEX I LIST OF THE NAMES, PHARMACEUTICAL FORM(S), STRENGTH(S) OF THE MEDICINAL PRODUCT(S), ROUTE(S) OF ADMINISTRATION, APPLICANT(S) / MARKETING AUTHORISATION HOLDER(S) IN THE MEMBER STATES 
DODATEK I SEZNAM IMEN, FARMACEVTSKIH OBLIK, JAKOSTI ZDRAVILA, POTI UPORABE ZDRAVILA , PREDLAGATELJEV/IMETNIKOV DOVOLJENJA ZA PROMET Z ZDRAVILOM V DRŽAVAH ČLANICAH
Cohort B included 24 children, 10 to 17 years of age and at Tanner Stage ≥2. 
Skupina B je vključevala 24 otrok, starih od 10 do 17 let in s stopnjo ≥ 2 po Tannerju.
ANNEX II AMENDMENTS TO THE SUMMARY OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLET 
DODATEK II DOPOLNILA POVZETKA GLAVNIH ZNAČILNOSTI ZDRAVILA, OZNAČEVANJA IN NAVODILA ZA UPORABO
- This medicine has been prescribed for you. 
- To zdravilo je bilo predpisano vam osebno in ga ne smete dajati drugim.
Important information about some of the ingredients of {PRODUCT NAME} If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product. 
Če vam je zdravnik povedal, da imate intoleranco za nekatere sladkorje, se pred uporabo tega zdravila posvetujte s svojim zdravnikom.
5.3 Preclinical safety data {To be completed nationally}. 
5.3 Predklinični podatki o varnosti {Izpolni država članica}.
Magnesium stearate Hydroxypropyl cellulose Amylum pregelificatum Mannitol (E421) Aspartame (E951) Sucralose (E955) Grape flavour 
6.1 Seznam pomožnih snovi kalcijev karbonat mikrokristalna celuloza premreženi natrijev karmelozat polisorbat 80 magnezijev stearat hidroksipropilceluloza predgelirani škrob manitol (E421) aspartam (E951) sukraloza (E955) grozdna aroma
WHAT {PRODUCT NAME} IS AND WHAT IT IS USED FOR {To be completed nationally}. 
KAJ JE ZDRAVILO X IN ZA KAJ GA UPORABLJAMO {Izpolni država članica}.
− Paediatric: Pharmacokinetic data in the paediatric population are not available. 
− Otroci: Farmakokinetičnih podatkov za otroke ni.
Each {PRODUCT NAME} 10 mg chewable tablet contains 1.25 mg aspartame. 
Ena {(Lastniško) ime}10 mg žvečljiva tableta vsebuje 1,25 mg aspartama.
In an openlabel, 8-week study, Tanner Stage 1 (N=15) and Tanner Stage ≥2 (N=24) paediatric patients (ages 6-17 years) with heterozygous familial hypercholesterolemia and baseline LDL-C ≥4 mmol/L were treated with 5 or 10 mg of chewable or 10 or 20 mg of film-coated atorvastatin tablets once daily, respectively. 
V odprti 8-tedenski študiji so pediatrični bolniki s stopnjo 1 po Tannerju (n = 15) in stopnjo ≥ 2 (n = 24) po Tannerju, stari od 6 do 17 let, z družinsko heterozigotno familiarno hiperholesterolemijo in izhodiščnim holesterolom LDL ≥ 4 mmol/l dobivali enkrat na dan 5 ali 10 mg atorvastatina v žvečljivih tabletah oz. 10 ali 20 mg atorvastatina v filmsko obloženih tabletah.
What {PRODUCT NAME} is and what it is used for Before you take {PRODUCT NAME} How to take {PRODUCT NAME} Possible side effects 
Kaj je zdravilo X in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo X Kako jemati zdravilo X
In a double-blind, placebo controlled study followed by an open-label phase, 187 boys and postmenarchal girls 10-17 years of age (mean age 14.1 years) with heterozygous familial hypercholesterolaemia (FH) or severe hypercholesterolaemia were randomised to atorvastatin (n=140) or placebo (n=47) for 26 weeks and then all received atorvastatin for 26 weeks.. 
V dvojno slepi, s placebom nadzorovani študiji, ki ji je sledila odprta faza, so 187 fantov in deklet (po nastopu menstruacije), starih od 10 do 17 let (povprečna starost 14,1 leta) s heterozigotno familiarno hiperholesterolemijo (FH) ali hudo hiperholesterolemijo za 26 tednov randomizirali na atorvastatin (n = 140) ali placebo (n = 47), potem pa so vsi še 26 tednov dobivali atorvastatin.
Each {PRODUCT NAME} 40 mg chewable tablet contains 5 mg aspartame. 
Ena {(Lastniško) ime}40 mg žvečljiva tableta vsebuje 5 mg aspartama.
MARKETING AUTHORISATION HOLDER [To be completed nationally] [See Annex I - To be completed nationally] {Name and address} 
IMETNIK DOVOLJENJA ZA PROMET [Izpolni država članica] [Glejte Dodatek I - Izpolni država članica] {Ime in naslov}
Each {PRODUCT NAME} 20 mg chewable tablet contains 2.5 mg aspartame. 
Ena {(Lastniško) ime}20 mg žvečljiva tableta vsebuje 2,5 mg aspartama.
OTHER SPECIAL WARNING(S), IF NECESSARY 
DRUGA POSEBNA OPOZORILA, ČE SO POTREBNA [Izpolni država članica].
The mean achieved LDL-C value was 3.38 mmol/l (range: 1.81-6.26 mmol/l) in the atorvastatin group compared to 5.91 mmol/l (range: 3.93-9.96 mmol/l) in the placebo group during the 26-week double-blind phase. 
Atorvastatin je med 26tedensko dvojno slepo fazo pomembno zmanjšal plazemsko koncentracijo celotnega holesterola, holesterola LDL, trigliceridov in apolipoproteina B. Med 26-tedensko dvojno slepo fazo je bila povprečna dosežena vrednost holesterola LDL v skupini z atorvastatinom 3,38 mmol/l (razpon: 1,81-6,26 mmol/l) in 5,91 mmol/l (razpon: 3,93-9,96 mmol/l) v skupini s placebom.
Atorvastatin significantly decreased plasma levels of total-C, LDL-C, triglycerides, and apolipoprotein B during the 26 week double-blind phase. 
Povprečne vrednosti holesterola LDL, trigliceridov, holesterola VLDL in apolipoproteina B so se pri vseh preiskovancih zmanjšale do 2. tedna.
− {To be completed nationally}. 
− {Izpolni država članica}.
MARKETING AUTHORISATION HOLDER [To be completed nationally] [See Annex I - To be completed nationally] {Name and address} <{tel}> <{fax}> <{e-mail}> 
IMETNIK DOVOLJENJA ZA PROMET [Izpolni država članica] [Glejte Dodatek I - Izpolni država članica] {Ime in naslov} <{tel.}>
How to store {PRODUCT NAME} Further information 
Shranjevanje zdravila X Dodatne informacije
White to off-white, round chewable tablets with pink to purple specks debossed "20" on one side and "Pfizer" on the other measuring 8.7 mm in diameter. 
Tablete imajo na eni strani vtisnjeno oznako "20" in na drugi "Pfizer" ter v premeru merijo 8,7 mm.
White to off-white, round chewable tablets with pink to purple specks, debossed "40" on one side and "Pfizer" on the other measuring 10.3 mm in diameter. 
Tablete imajo na eni strani vtisnjeno oznako "40" in na drugi "Pfizer" ter v premeru merijo 10,3 mm.
White to off-white, round chewable tablets with pink to purple specks, debossed "10" on one side and “Pfizer” on the other measuring 7.1 mm in diameter. 
Tablete imajo na eni strani vtisnjeno oznako "10" in na drugi "Pfizer" ter v premeru merijo 7,1 mm.
INFORMATION IN BRAILLE {PRODUCT NAME} 20 mg chewable tablets 
PODATKI V BRAILLOVI PISAVI {(Lastniško) ime} 20 mg žvečljive tablete
INFORMATION IN BRAILLE {PRODUCT NAME} 10 mg chewable tablets 
PODATKI V BRAILLOVI PISAVI {(Lastniško) ime} 10 mg žvečljive tablete
INFORMATION IN BRAILLE {PRODUCT NAME} 40 mg chewable tablets 
PODATKI V BRAILLOVI PISAVI {(Lastniško) ime} 40 mg žvečljive tablete
{PRODUCT NAME} 10 mg chewable tablets Atorvastatin calcium [See Annex I - To be completed nationally] 
{(Lastniško) ime} 10 mg žvečljive tablete atorvastatin [Glejte Dodatek I - Izpolni država članica]
{PRODUCT NAME} 40 mg chewable tablets Atorvastatin calcium [See Annex I - To be completed nationally] 
{(Lastniško) ime} 40 mg žvečljive tablete atorvastatin [Glejte Dodatek I - Izpolni država članica]
{PRODUCT NAME} 20 mg chewable tablets Atorvastatin calcium [See Annex I - To be completed nationally] 
{(Lastniško) ime} 20 mg žvečljive tablete atorvastatin [Glejte Dodatek I - Izpolni država članica]
What {PRODUCT NAME} looks like and contents of the pack {PRODUCT NAME} 40 mg chewable tablets are white to off-white with pink to purple specks with a round shape. 
Izgled zdravila X in vsebina pakiranja {(Lastniško) ime} 40 mg žvečljive tablete so bele do umazano bele, okrogle žvečljive tablete z rožnatimi do vijoličastimi lisami.
NAME OF THE MEDICINAL PRODUCT [See Annex I - To be completed nationally] {PRODUCT NAME} 20 mg chewable tablet 
IME ZDRAVILA [Glejte Dodatek I - Izpolni država članica] {(Lastniško) ime} 20 mg žvečljiva tableta
NAME OF THE MEDICINAL PRODUCT {PRODUCT NAME} 20 mg chewable tablets Atorvastatin 
IME ZDRAVILA {(Lastniško) ime} 20 mg žvečljive tablete atorvastatin
What {PRODUCT NAME} looks like and contents of the pack {PRODUCT NAME} 20 mg chewable tablets are white to off-white with pink to purple specks with a round shape. 
Izgled zdravila X in vsebina pakiranja {(Lastniško) ime} 20 mg žvečljive tablete so bele do umazano bele, okrogle žvečljive tablete z rožnatimi do vijoličastimi lisami.
NAME OF THE MEDICINAL PRODUCT [See Annex I - To be completed nationally] {PRODUCT NAME} 10 mg chewable tablet 
IME ZDRAVILA [Glejte Dodatek I - Izpolni država članica] {(Lastniško) ime} 10 mg žvečljiva tableta
What {PRODUCT NAME} looks like and contents of the pack {PRODUCT NAME} 10 mg chewable tablets are white to off-white with pink to purple specks with a round shape. 
Izgled zdravila X in vsebina pakiranja {(Lastniško) ime} 10 mg žvečljive tablete so bele do umazano bele, okrogle žvečljive tablete z rožnatimi do vijoličastimi lisami.
NAME OF THE MEDICINAL PRODUCT {PRODUCT NAME} 40 mg chewable tablets Atorvastatin 
IME ZDRAVILA {(Lastniško) ime} 40 mg žvečljive tablete atorvastatin
An 8-week, open-label study to evaluate pharmacokinetics, pharmacodynamics, and safety and tolerability of atorvastatin was conducted in children and adolescents with genetically confirmed heterozygous familial hypercholesterolemia and baseline LDL-C ≥4 mmol/L. 
Pri otrocih in mladostnikih z genetsko potrjeno heterozigotno familiarno hiperholesterolemijo in izhodiščnim holesterolom LDL ≥ 4 mmol/l je bila opravljena 8-tedenska odprta študija za oceno farmakokinetike, farmakodinamike ter varnosti in prenašanja atorvastatina.
NAME OF THE MEDICINAL PRODUCT {PRODUCT NAME} 10 mg chewable tablets Atorvastatin 
IME ZDRAVILA {(Lastniško) ime} 10 mg žvečljive tablete atorvastatin
NAME OF THE MEDICINAL PRODUCT [See Annex I - To be completed nationally] {PRODUCT NAME} 40 mg chewable tablet 
IME ZDRAVILA [Glejte Dodatek I - Izpolni država članica] {(Lastniško) ime} 40 mg žvečljiva tableta
They are marked with 20 on one side and Pfizer on the other side. 
Tablete imajo na eni strani vtisnjeno oznako "20" in na drugi "Pfizer".
They are marked with 10 on one side and Pfizer on the other side. 
Tablete imajo na eni strani vtisnjeno oznako "10" in na drugi "Pfizer".
QUALITATIVE AND QUANTITATIVE COMPOSITION Each chewable tablet contains 20 mg atorvastatin (as atorvastatin calcium (trihydrate)). 
KAKOVOSTNA IN KOLIČINSKA SESTAVA Ena žvečljiva tableta vsebuje 20 mg atorvastatina (v obliki kalcijevega atorvastatinata trihidrata).
QUALITATIVE AND QUANTITATIVE COMPOSITION Each chewable tablet contains 40 mg atorvastatin (as atorvastatin calcium (trihydrate)). 
KAKOVOSTNA IN KOLIČINSKA SESTAVA Ena žvečljiva tableta vsebuje 40 mg atorvastatina (v obliki kalcijevega atorvastatinata trihidrata).
They are marked with 40 on one side and Pfizer on the other side. 
Tablete imajo na eni strani vtisnjeno oznako "40" in na drugi "Pfizer".
QUALITATIVE AND QUANTITATIVE COMPOSITION Each chewable tablet contains 10 mg atorvastatin (as atorvastatin calcium (trihydrate)). 
KAKOVOSTNA IN KOLIČINSKA SESTAVA Ena žvečljiva tableta vsebuje 10 mg atorvastatina (v obliki kalcijevega atorvastatinata trihidrata).
Each tablet contains 20 mg of atorvastatin as atorvastatin calcium trihydrate. 
Ena tableta vsebuje 20 mg atorvastatina (v obliki kalcijevega atorvastatinata trihidrata).
Each tablet contains 40 mg of atorvastatin as atorvastatin calcium trihydrate. 
Ena tableta vsebuje 40 mg atorvastatina (v obliki kalcijevega atorvastatinata trihidrata).
Each tablet contains 10 mg of atorvastatin as atorvastatin calcium trihydrate. 
Ena tableta vsebuje 10 mg atorvastatina (v obliki kalcijevega atorvastatinata trihidrata).
STATEMENT OF ACTIVE SUBSTANCE(S) 1 chewable tablet contains 10 mg atorvastatin (as calcium salt trihydrate). 
NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Ena žvečljiva tableta vsebuje 10 mg atorvastatina (v obliki kalcijevega atorvastatinata trihidrata).
STATEMENT OF ACTIVE SUBSTANCE(S) 1 chewable tablet contains 20 mg atorvastatin (as calcium salt trihydrate). 
NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Ena žvečljiva tableta vsebuje 20 mg atorvastatina (v obliki kalcijevega atorvastatinata trihidrata).
STATEMENT OF ACTIVE SUBSTANCE(S) 1 chewable tablet contains 40 mg atorvastatin (as calcium salt trihydrate). 
NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Ena žvečljiva tableta vsebuje 40 mg atorvastatina (v obliki kalcijevega atorvastatinata trihidrata).
by washing your hands. 
se tako, da si umijete roke.
I'm not sure my pen worked correctly. 
Nisem prepričan/a, da je moj peresnik deloval pravilno.
Check to see if you have received your dose. 
Preverite, ali ste prejeli vaš odmerek.
Read both sides for full instructions 
Za celotna navodila preberite obe strani.
Date of latest renewal: 23 August 2019 
Datum zadnjega podaljšanja: 23. avgust 2019
Your doctor may need to change your dose of these other medicines to reduce this risk. 
Vaš zdravnik bo morda moral spremeniti vaš odmerek teh drugih zdravil, da bo zmanjšal tveganje.
These effects were sustained to the end of the study (104 weeks). 
Ti učinki so se ohranili vse do konca študije (104. tedna).
Some patients may hear a soft click right before the second loud click. 
Nekateri bolniki lahko slišijo tišji klik tik pred drugim glasnim klikom.
# From post-marketing reports. 
# Iz poročil v obdobju trženja.
This is not necessary, but it may help you keep the pen steady and firm against your skin. 
To ni potrebno, morda pa vam bo pomagalo, da boste peresnik držali bolj mirno in trdno na koži.
Each MACE component contributed to the reduction of MACE, as shown in Figure 2. 
Vsaka komponenta MACE je prispevala k zmanjšanju MACE, kot je prikazano na sliki 2.
• in addition to other medicinal products for the treatment of diabetes. 
• poleg drugih zdravil za zdravljenje sladkorne bolezni.
You should see a doctor immediately if you experience such symptoms. 
Takoj morate obiskati zdravnika, če se pri vas pojavijo takšni simptomi.
COMMONLY ASKED QUESTIONS 
POGOSTO ZASTAVLJENA VPRAŠANJA
The median study follow-up time was 5.4 years. 
Mediani čas spremljanja v študiji je bil 5,4 leta.
Make sure the pen is locked. 
Prepričajte se, da je peresnik zaklenjen.
Your dose was delivered correctly if the grey part is visible (see step 3.) 
Vaš odmerek je bil pravilno dostavljen, če je sivi del viden (Glejte korak 3).
Press and hold the green injection button; you will hear a loud click. 
• Pritisnite in podržite zeleni gumb za injiciranje; slišali boste glasen klik.
In each case, patients can then resume their regular once weekly dosing schedule. 
V vsakem primeru lahko bolniki takrat nadaljujejo s svojim rednim urnikom odmerjanja enkrat na teden.
pharmacist or nurse. 
farmacevt ali medicinska sestra.
In the event of overdose, appropriate supportive treatment should be initiated according to the patient's clinical signs and symptoms. 
V primeru prevelikega odmerjanja je treba uvesti ustrezno podporno zdravljenje v skladu z bolnikovimi kliničnimi znaki in simptomi.
Did I get my complete injection? 
Ali sem prejel/a celotno injekcijo?
While metoprolol tmax was delayed by 1 hour, this change was not statistically significant. 
Čeprav je bil tmax metoprolola zakasnjen za 1 uro, ta sprememba ni bila statistično pomembna.
You may give them an infection or get an infection from them. 
S tem bi jim lahko prenesli okužbo ali pa bi dobili okužbo od njih.
These other medicines may be medicines taken by mouth and/or insulin given by injection. 
Ta druga zdravila so lahko zdravila, ki se jih jemlje prek ust in/ali insulin, ki se ga daje z injekcijo.
Patients should be informed of the characteristic symptoms of acute pancreatitis. 
Bolnike je treba opozoriti na značilne simptome akutnega pankreatitisa.
The requirements for submission of PSURs for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal. 
• Zahteve glede predložitve PSUR za to zdravilo so določene v seznamu referenčnih datumov EU (seznamu EURD), opredeljenem v členu 107c(7) Direktive 2001/83/ES, in vseh kasnejših posodobitvah, objavljenih na evropskem spletnem portalu o zdravilih.
(below 30°C) for up to a total of 14 days. 
30 °C), skupno največ 14 dni.
Prepare from the refrigerator. 
Pripravite iz hladilnika.
- you have severe problems with food digestion or food remaining in your stomach for longer than normal (including gastroparesis). 
- imate hude težave s prebavljanjem hrane oz. če hrana zastaja v vašem želodcu dlje časa, kot je normalno (vključno z gastroparezo).
• The pen contains glass parts. 
• Peresnik vsebuje steklene dele.
First degree AV block/PR interval prolongation 
Atrioventrikularni blok prve stopnje/ podaljšanje intervala PR
Patients discontinued their prestudy insulin regimen at randomisation. 
Bolniki so svoj predštudijski insulinski režim prekinili ob randomizaciji.
Therefore, dulaglutide does have a high degree of protection against DPP-4 inactivation (see section 5.1, Mechanism of action). 
Tako ima dulaglutid visoko stopnjo zaščite pred inaktivacijo DPP-4 (glejte poglavje 5.1 Mehanizem delovanja).
I heard more than two clicks during my injection - two louder clicks and a soft one. 
Med injiciranjem sem slišal/a več kot dva klika - dva glasnejša klika in enega tišjega.
• Trulicity is administered once a week. 
• Zdravilo Trulicity se daje enkrat na teden.
These side effects are usually not severe. 
Ti neželeni učinki običajno niso hudi.
In general these reactions were mild or moderate in severity and transient in nature. 
Ti neželeni učinki so bili na splošno blagi ali zmerni in prehodne narave.
104 weeks 
104 tednov
When this happens, sugar (glucose) builds up in the blood. 
Ko pride do tega, se sladkor (glukoza) kopiči v krvi.
I don't know how to do a subcutaneous injection. 
Ne znam izvesti subkutanega injiciranja.
Talk to your doctor about the best way to control your blood sugar while you are pregnant. 
Pogovorite se z zdravnikom o najboljšem načinu za uravnavanje vašega krvnega sladkorja v nosečnosti.
The GLP-1 analog portion of dulaglutide is approximately 90 % homologous to native human GLP-1 (7-37). 
Analogni del GLP-1 dulaglutida je približno 90 % homologen naravnemu humanemu GLP-1 (7-37).
For study results with respect to combinations, effects on glycaemic control and cardiovascular events, and the populations studied, see sections 4.4, 4.5 and 5.1. 
Za rezultate študij glede na kombinacije, učinke na glikemično urejenost in kardiovaskularne dogodke, in na preučevano populacijo, glejte poglavja 4.4., 4.5 in 5.1.
^ Patients who withdrew from randomized treatment before 24 weeks were considered as not meeting the target 
^ Bolniki, ki so z randomiziranim zdravljenjem zaključili pred 24. tednom, se smatrajo, kot da niso dosegli ciljne vrednosti.
The effect of dulaglutide on fertility in humans is unknown. 
Učinek dulaglutida na plodnost pri človeku ni znan.
There were 3,114 (31.5 %) patients with established CV disease. 
3114 (31,5 %) bolnikov je imelo potrjeno KV-bolezen.
You can also change the day of the week on which you inject Trulicity if necessary, as long as it has been at least 3 days since your last dose of Trulicity. 
Po potrebi lahko tudi spremenite dan v tednu, na katerega si injicirate zdravilo Trulicity, a le, če so minili vsaj 3 dnevi od vašega zadnjega odmerka zdravila Trulicity.
IMPORTANT INFORMATION 
POMEMBNE INFORMACIJE
In addition, the dulaglutide molecule was engineered to prevent the Fcγ receptor-dependent immune response and to reduce its immunogenic potential. 
Poleg tega je bila molekula dulaglutida izdelana tako, da preprečuje imunski odziv, odvisen od receptorja Fcγ, in da zmanjšuje njegov imunogeni potencial.
Use of GLP-1 receptor agonists has been associated with a risk of developing acute pancreatitis. 
Akutni pankreatitis Uporaba receptorskih agonistov GLP-1 je bila povezana s tveganjem nastanka akutnega pankreatitisa.
In a 6-month carcinogenicity study in transgenic mice, there was no tumorigenic response. 
V 6-mesečni študiji karcinogenosti pri transgenskih miših ni bilo tumorogenega odziva.
Frequencies for events have been calculated based on their incidence in the phase II and phase III registration studies. 
Pogostnosti dogodkov so bile izračunane na podlagi njihove pojavnosti v registracijskih študijah 2. in 3. faze.
Once weekly. 
Enkrat tedensko.
• Do not share your syringe with anyone else. 
• Injekcijske brizge ne delite z nikomer drugim.
The day of weekly administration can be changed if necessary, as long as the last dose was administered 3 or more days (72 hours) before. 
Dan tedenskega odmerjanja je po potrebi mogoče spremeniti, v kolikor je bil zadnji odmerek apliciran 3 ali več dni (72 ur) pred tem.
Air bubbles are normal. 
Zračni mehurčki so normalen pojav.
Week 1 Week 2 Week 3 Week 4 
1. teden 2. teden 3. teden 4. teden
The safety and efficacy of dulaglutide were evaluated in nine randomised, controlled, phase III trials involving 6,193 patients with type 2 diabetes. 
Varnost in učinkovitost zdravila dulaglutida sta bili ugotovljeni v devetih randomiziranih, nadziranih preskušanjih III. faze, ki so vključevala 6193 bolnikov s sladkorno boleznijo tipa 2.
The clinical relevance of these findings is currently unknown. 
Pomen teh ugotovitev za človeka trenutno ni znan.
WHERE TO LEARN MORE 
KJE DOBITI VEČ PODATKOV
The safety and efficacy of dulaglutide in children aged less than 18 years have not yet been established. 
Varnost in učinkovitost dulaglutida pri otrocih, starih manj kot 18 let, še nista bili ugotovljeni.