natgillin/translations-raw huggingface dataset:
Tresiba 100 units/mL and Tresiba 200 units/mL solution for injection in a pre-filled pen Tresiba comes in a pre-filled pen (FlexTouch) designed to be used with NovoFine or NovoTwist injection needles. 
Tresiba 100 jedinica/ml i Tresiba 200 jedinica/ml otopina za injekciju u napunjenoj brizgalici Tresiba dolazi u obliku napunjene brizgalice (FlexTouch) namijenjene uporabi s iglama za injekciju NovoFine ili NovoTwist.
• Ensuring you use the right type of insulin - always check the insulin label before each injection to avoid accidental mix-ups between different strengths of Tresiba as well as other insulin products. 
• Provjerite koristite li odgovarajuću vrstu inzulina - uvijek provjerite naljepnicu na inzulinu prije svakog injiciranja kako biste izbjegli slučajnu zabunu između različitih jačina lijeka Tresiba, ali i drugih inzulinskih pripravaka.
The re-use of insulin pen needles increases the risk of blocked needles, which may cause under- or overdosing. 
Ponovna uporaba iste igle za inzulinsku brizgalicu povećava rizik od začepljenja igle, što može dovesti do primjene premale ili prevelike doze lijeka.
Ratio: 0.64 [0.30; 1.37] 
Omjer: 0,64 [0,30; 1,37]
Before first use Store in a refrigerator (2°C to 8°C). 
Prije prve uporabe Čuvati u hladnjaku (2°C do 8°C).
End of treatment FPG (mmol/L) 
GUP natašte (mmol/l)
Before you use Tresiba for the first time, your doctor or nurse will show you how to use the pre-filled pen. 
Injiciranje lijeka Prije prve primjene lijeka Tresiba, Vaš liječnik ili medicinska sestra pokazat će Vam kako se koristi napunjena brizgalica.
• Make sure the dose counter shows 0 before you start. 
• Prije početka provjerite da je brojčanik doze postavljen na 0.
Hyperglycaemia Administration of rapid-acting insulin is recommended in situations with severe hyperglycaemia. 
U teškoj hiperglikemiji preporučuje se primjena brzodjelujućeg inzulina.
6 units selected 
odabrano 6 jedinica
Ratio: 0.82 [0.64; 1.04] 
Omjer: 0,82 [0,64; 1,04]
24 units selected 
Primjeri odabrane 24 jedinice
1 mL solution contains 200 units insulin degludec* (equivalent to 7.32 mg insulin degludec). 
1 ml otopine sadrži 200 jedinica degludek inzulina* (što odgovara 7,32 mg degludek inzulina).
In a 104-week clinical trial, 57% of patients with type 2 diabetes treated with Tresiba (insulin degludec) in combination with metformin achieved a target HbA1c <7.0%, and the remaining patients continued in a 26-week open-label trial and were randomised to add liraglutide or a single dose of insulin aspart (with the largest meal). 
U kliničkom ispitivanju koje je trajalo 104 tjedna, 57% bolesnika sa šećernom bolešću tipa 2 liječeno lijekom Tresiba (degludek inzulin) u kombinaciji s metforminom postiglo je ciljni HbA1c < 7,0%.
Tresiba pre-filled pen 200 units/mL 
Tresiba napunjena brizgalica 200 jedinica/ml
Ratio: 1.03 [0.75; 1.40] 
Omjer: 1,03 [0,75; 1,40]
Table 6 Results from an open-label clinical trial with flexible dosing of Tresiba in type 2 diabetes mellitus 
Tablica 6 Rezultati otvorenog kliničkog ispitivanja pri fleksibilnom vremenu doziranja lijeka Tresiba kod šećerne bolesti tipa 2
If you do not follow the instructions carefully, you may get too little or too much insulin, which can lead to too high or too low blood sugar level. 
Ako se ne budete pažljivo pridržavali uputa, možda ćete primiti premalo ili previše inzulina, što može dovesti do previsoke ili preniske razine šećera u krvi.
EU/1/12/807/008 
EU/1/12/807/007 EU/1/12/807/008
Each mL of solution contains 200 units of insulin degludec. 
Jedan ml otopine sadrži 200 jedinica degludek inzulina.
Time since injection (hours) Treatment 
Vrijeme proteklo od injiciranja (sati) Liječenje IDeg 0,6 jedinica/kg
There is no clinical experience with Tresiba during breast-feeding. 
Nema kliničkog iskustva s primjenom lijeka Tresiba tijekom dojenja.
If you split the dose wrong, you will inject too little or too much insulin, which can lead to too high or too low blood sugar level. 
Ako pogrešno podijelite dozu, injicirat ćete premalo ili previše inzulina, što može dovesti do previsoke ili preniske razine šećera u krvi.
Do not use the pen without proper training from your doctor or nurse. 
Ne koristite brizgalicu ako Vam liječnik ili medicinska sestra nisu pokazali kako se ispravno koristi.
Substances added to Tresiba may cause degradation of insulin degludec. 
Tvari dodane lijeku Tresiba mogu izazvati razgradnju degludek inzulina.
This makes sure that the insulin flows. 
Tako ćete biti sigurni da inzulin protječe kroz iglu.
Close glucose monitoring is recommended during the transfer and in the following weeks. 
Tijekom prijelaza i u tjednima nakon toga preporučuje se pomno pratiti razine glukoze.
Patients must be instructed to always check the insulin label before each injection to avoid accidental mix-ups between the two different strengths of Tresiba as well as other insulin products. 
Izbjegavanje medikacijskih pogrešaka Bolesnicima se mora objasniti da prije svakog injiciranja uvijek provjere naljepnicu na inzulinu radi izbjegavanja slučajne zamjene dviju različitih jačina lijeka Tresiba, kao i drugih inzulinskih pripravaka.
Pioglitazone: oral antidiabetic medicine used to treat type 2 diabetes mellitus. 
Pioglitazon: lijek za liječenje šećerne bolesti tipa 2 koji se uzima kroz usta.
Tresiba can be used with meal-related rapid-acting insulin products. 
Tresiba se može primjenjivati u kombinaciji s brzodjelujućim inzulinskim lijekovima koji se primjenjuju uz obrok.
Ratio: 0.86 [0.58; 1.28] 
Omjer: 0,86 [0,58; 1,28]
1 mL solution contains 100 units insulin degludec* (equivalent to 3.66 mg insulin degludec). 
1 ml otopine sadrži 100 jedinica degludek inzulina* (što odgovara 3,66 mg degludek inzulina).
In the open-label trials the effect of Tresiba was tested in patients with type 1 diabetes mellitus (Table 3), in insulin naïve patients (insulin initiation in type 2 diabetes mellitus, Table 4) and in previous insulin users (insulin intensification in type 2 diabetes mellitus, Table 5) with fixed as well as flexible dosing time (Table 6), and the reduction in HbA1c from baseline to end of trial was confirmed to be non-inferior in all trials against all comparators (insulin detemir and insulin glargine (100 units/mL)). 
U otvorenim ispitivanjima učinak lijeka Tresiba ispitan je u bolesnika sa šećernom bolesti tipa 1 (Tablica 3), u bolesnika koji nisu koristili inzulin (početak primjene inzulina kod šećerne bolesti tipa 2, Tablica 4) i u onih koji su već koristili inzulin (intenziviranje inzulinskog liječenja kod šećerne bolesti tipa 2, Tablica 5), s fiksnim i s fleksibilnim vremenom doziranja (Tablica 6).
The pre-filled pen (FlexTouch) is designed to be used with NovoFine/NovoTwist injection needles up to a length of 8 mm. 
Napunjena brizgalica (FlexTouch) namijenjena je uporabi s iglama za injekciju NovoFine/NovoTwist,
It is used for once-daily dosing. 
Primjenjuje se jednom dnevno.
Ratio: 0.66 [0.49; 0.88] 
Omjer: 0,66 [0,49; 0,88]
Ratio: 0.77 [0.44; 1.35] 
Omjer: 0,77 [0,44; 1,35]
Very common Hypoglycaemia 
Teška hipoglikemija
Ratio: 1.07 [0.89; 1.28] 
Omjer: 1,07 [0,89; 1,28]
Difference: -0.42 [-0.78; -0.06] 
Razlika: -0,42 [-0,78; -0,06]
1 In a once-daily regimen + insulin aspart to cover mealtime insulin requirements 
1 Primjena jednom dnevno + aspart inzulin za pokrivanje potreba za inzulinom u vrijeme obroka.
Difference: 0.09 [-0.04; 0.22] 
Razlika: 0,09 [-0,04; 0,22]
Ratio: 0.75 [0.59; 0.96] 
Omjer: 0,75 [0,59; 0,96]
Ratio: 0.70 [0.61; 0.80] 
Omjer: 0,70 [0,61; 0,80]
In addition, Tresiba 100 units/mL packaging and label are light green, and Tresiba 200 units/mL packaging and label are dark green with striping with a red box highlighting the formulation strength. 
Osim toga, pakiranje i naljepnica lijeka Tresiba 100 jedinica/ml su svjetlozelene boje, dok Tresiba 200 jedinica/ml ima pakiranje i naljepnicu tamnozelene boje s prugama te jačinu formulacije istaknutu crvenim okvirom.
Each mL of solution contains 100 units of insulin degludec. 
Jedan ml otopine sadrži 100 jedinica degludek inzulina.
Rate of hypoglycaemia (per patient year of exposure) Severe 
Stopa hipoglikemije (za izloženost po bolesnik-godina)
Contents of the pack and other information 
Kako čuvati lijek Tresiba Sadržaj pakiranja i druge informacije
Rate of severe or BG confirmed symptomatic nocturnal hypoglycaemia Maintenance period4 
Stopa teške ili simptomatske hipoglikemije potvrđene razinom glukoze u krvi Razdoblje održavanja4
Tresiba can be used in renal and hepatic impaired patients. 
Tresiba se može primjenjivati u bolesnika s oštećenjem bubrega i jetre.
When changing basal insulin to Tresiba, dose reduction of basal and bolus insulin needs to be considered on an individual basis in order to minimise the risk of hypoglycaemia (see section 
Kad se prelazi s bazalnog inzulina na lijek Tresiba, potrebno je razmotriti individualno smanjenje doze bazalnog i bolus inzulina,
• Press and hold down the dose button until the dose counter returns to 0. 
• Pritisnite gumb za doziranje i držite ga pritisnutim sve dok se brojčanik doze ne vrati na 0.
Do not withdraw solution from the pen 
Otopina se ne smije izvlačiti iz brizgalice.
Ratio: 0.64 [0.42; 0.98] 
Omjer: 0,64 [0,42; 0,98]
Method of administration Subcutaneous use only. 
Samo za supkutanu primjenu.
EU/1/12/807/001 1 pen of 3 mL EU/1/12/807/002 1 pen of 3 mL and 7 NovoFine needles EU/1/12/807/003 1 pen of 3 mL and 7 NovoTwist needles EU/1/12/807/004 5 pens of 3 mL 
EU/1/12/807/001 1 brizgalica od 3 ml EU/1/12/807/002 1 brizgalica od 3 ml i 7 NovoFine igala EU/1/12/807/003 1 brizgalica od 3 ml i 7 NovoTwist igala EU/1/12/807/004 5 brizgalica od 3 ml
Difference: 0.08 [-0.05; 0.21] 
Razlika: 0,08 [-0,05; 0,21]
Ratio: 0.98 [0.80; 1.20] 
Omjer: 0,98 [0,80; 1,20]
See advice in ‘Too low blood sugar' below. 
Pogledajte savjete u dijelu ‘Preniska razina šećera u krvi', u nastavku.
Ratio: 0.65 [0.48; 0.89] 
Omjer: 0,65 [0,48; 0,89]
Name and address of the manufacturers of the biological active substance 
Nazivi i adrese proizvođača biološke djelatne tvari Novo Nordisk A/S
1 Once-daily regimen + insulin aspart to cover mealtime insulin requirements ± metformin ± pioglitazone 2 Once-daily regimen ± metformin SU/glinide ± pioglitazone 
1 Primjena jednom dnevno + aspart inzulin za pokrivanje potreba za inzulinom u vrijeme obroka ± metformin ± pioglitazon
Table 4 Results from open-label clinical trials in insulin naïve type 2 diabetes mellitus (insulin initiation) 
Tablica 4 Rezultati otvorenih kliničkih ispitivanja u bolesnika sa šećernom bolešću tipa 2 koji ranije nisu koristili inzulin (početak primjene inzulina)
What Tresiba looks like and contents of the pack Tresiba is presented as a clear and colourless solution for injection in a cartridge (300 units per 3 mL). 
Kako Tresiba izgleda i sadržaj pakiranja Tresiba dolazi u obliku bistre i bezbojne otopine za injekciju u ulošku (300 jedinica u 3 ml).
Ratio: 0.89 [0.85; 0.94] 
Omjer: 0,89 [0,85; 0,94]
Please read these instructions carefully before using your FlexTouch pre-filled pen. 
Prije uporabe Vaše FlexTouch napunjene brizgalice, molimo pažljivo pročitajte ove upute.
If you use too much insulin, your blood sugar may get too low (hypoglycaemia), see advice in section 4 ‘Too low blood sugar'. 
Ako primijenite previše inzulina, može doći do prevelikog snižavanja razine šećera u krvi (hipoglikemija), pogledajte savjete u dijelu 4.
In a prospectively planned meta-analysis across seven open-label treat-to-target confirmatory trials in patients with type 1 and type 2 diabetes mellitus, Tresiba was superior in terms of a lower number of treatment-emergent confirmed hypoglycaemic episodes (driven by a benefit in type 2 diabetes mellitus, see Table 2) and nocturnal confirmed hypoglycaemic episodes compared to insulin glargine (100 units/ml) (administered according to label). 
2, Tresiba je bila superiornija s obzirom na manji broj potvrđenih epizoda hipoglikemije (s obzirom na korist kod šećerne bolesti tipa 2, vidjeti Tablicu 2) i noćnih potvrđenih hipoglikemija u usporedbi s glargin inzulinom (100 jedinica/ml) (primjenjen u skladu s odobrenjem).
After first opening or if carried as a spare 
Nakon prvog otvaranja ili ako se lijek nosi kao rezervni Ne odlagati u hladnjak.
- The 100 units/mL pre-filled pen delivers 1-80 units in steps of 1 unit. 
- Napunjena brizgalica od 100 jedinica/ml isporučuje 1-80 jedinica u stupnjevima od 1 jedinice.
Your pen is a pre-filled dial-a-dose insulin pen containing 600 units of insulin. 
Vaša brizgalica je napunjena inzulinska brizgalica s mogućnošću odabira doze, koja sadrži 600 jedinica inzulina.
End of trial Mean change 
Na kraju ispitivanja
- The 200 units/mL pre-filled pen delivers 2-160 units in steps of 2 units. 
- Napunjena brizgalica od 200 jedinica/ml isporučuje 2-160 jedinica u stupnjevima od 2 jedinice.
“Tresiba 100 units/mL” or “Tresiba 200 units/mL” is clearly marked on the pen label and packaging. 
Na naljepnici brizgalice i pakiranju jasno je navedeno „Tresiba 100 jedinica/ml“ ili „Tresiba 200 jedinica/ml“.
Usual warning symptoms may disappear in patients with long-standing diabetes. 
U osoba koje dugo boluju od šećerne bolesti uobičajeni upozoravajući simptomi mogu nestati.
SS: Steady State 
s.c. primjena
Nocturnal confirmed hypoglycaemia was defined as episodes between midnight and 6 a.m. b Episodes from week 16. 
Noćna potvrđena hipoglikemija definirana je kao epizoda u vremenu od ponoći do 6 sati ujutro.
• With Tresiba 200 units/mL a dose of 2-160 units per injection, in steps of 2 units, can be administered. 
• Kod primjene lijeka Tresiba 200 jedinica/ml, može se primijeniti doza od 2-160 jedinica po injekciji, u stupnjevima od 2 jedinice.
METHOD AND ROUTE OF ADMINISTRATION Read the package leaflet before use Subcutaneous use 
NAČIN I PUT PRIMJENE LIJEKA Prije uporabe pročitajte uputu o lijeku.
Ratio: 0.64 [0.56; 0.73] 
Omjer: 0,64 [0,56; 0,73]
• The other ingredients are glycerol, metacresol, phenol, zinc acetate, hydrochloric acid and sodium hydroxide (for pH adjustment) and water for injections (see section 2). 
• Drugi sastojci su glicerol, metakrezol, fenol, cinkov acetat, kloridna kiselina i natrijev hidroksid
Difference: 0.04 [-0.12; 0.20] 
Razlika: 0,04 [-0,12; 0,20]
Rate ratio: 0.47 [0.31; 0.73] 
Omjer stopa: 0,47 [0,31; 0,73]
Always make sure that a drop appears at the needle tip before you inject. 
Prije injiciranja uvijek provjerite da se kapljica pojavila na vrhu igle.
Ratio: 0.75 [0.58; 0.99] 
Omjer: 0,75 [0,58; 0,99]
Insulin degludec (N26) (CV%) 
(N26) (CV%)
The pre-filled pen 100 units/mL can provide a dose of 1-80 units in one injection in steps of 1 unit. 
Napunjena brizgalica od 100 jedinica/ml može isporučiti dozu od 1-80 jedinica po injekciji u stupnjevima od 1 jedinice.
Ratio: 1.10 [0.79; 1.52] 
Omjer: 1,10 [0,79; 1,52]6
• With Tresiba 100 units/mL a dose of 1-80 units per injection, in steps of 1 unit, can be administered. 
• Kod primjene lijeka Tresiba 100 jedinica/ml, može se primijeniti doza od 1-80 jedinica po injekciji, u stupnjevima od 1 jedinice.
Ratio: 0.58 [0.46; 0.74] 
Omjer: 0,58 [0,46; 0,74]
Ratio: 0.82 [0.69; 0.99] 
Omjer: 0,82 [0,69; 0,99]
Basal only therapy in previously insulin-naïve 
Liječenje samo bazalnim inzulinom u bolesnika koji ranije nisu koristili inzulin
However, hypoglycaemia may develop over sequential stages if a patient is dosed with more insulin than required: 
Međutim, ako se primijene doze koje su prevelike u odnosu na bolesnikovu potrebu, može se razviti hipoglikemija u nekoliko različitih stadija:
Difference: -0.43 [-0.61; -0.24] 
Razlika: -0,43 [-0,61; -0,24]
• Hold the pen with the needle pointing up. 
• Držite brizgalicu s iglom okrenutom prema gore.
This means that the medicine is essentially ‘sodium-free'. 
To znači da lijek sadrži zanemarive količine natrija.
Based on your blood sugar level, your doctor may change your dose. 
Liječnik može promijeniti Vašu dozu na temelju razine šećera u krvi.
Dose selector Dose button 
Gumb za doziranje
MI: Myocardial infarction. 
Infarkt miokarda bez smrtnog ishoda
Approx. how much insulin is left 
Približna količina preostalog inzulina
• thyroid hormones, for thyroid problems 
• hormone štitnjače, za probleme sa štitnjačom
Insulin degludec monomers gradually separate from the multi-hexamers thus resulting in a slow and continuous delivery of insulin degludec into the circulation. 
Monomeri degludek inzulina postupno se odvajaju od multiheksamera,
PHARMACEUTICAL FORM AND CONTENTS Solution for injection (FlexTouch) Multipack: 6 (2 packs of 3) 3 mL pre-filled pens 
Višestruko pakiranje: 6 (2 pakiranja po 3) napunjenih brizgalica od 3 ml
Tresiba 200 units/mL solution for injection in pre-filled pen Before first use: 
Tresiba 200 jedinica/ml otopina za injekciju u napunjenoj brizgalici Prije prve uporabe:
Odds ratio: 0.73 [0.60; 0.89] 
Omjer izgleda: 0,73 [0,60; 0,89]
• Make sure you can see the dose counter. 
• Provjerite da je brojčanik doze vidljiv.
NAME OF THE MEDICINAL PRODUCT Tresiba 100 units/mL solution for injection in pre-filled pen Tresiba 200 units/mL solution for injection in pre-filled pen Tresiba 100 units/mL solution for injection in cartridge 
Tresiba 100 jedinica/ml otopina za injekciju u napunjenoj brizgalici Tresiba 200 jedinica/ml otopina za injekciju u napunjenoj brizgalici Tresiba 100 jedinica/ml otopina za injekciju u ulošku
The pre-filled pen 200 units/mL can provide a dose of 2-160 units in one injection in steps of 2 units. 
Napunjena brizgalica od 200 jedinica/ml može isporučiti dozu od 2-160 jedinica po injekciji u stupnjevima od 2 jedinice.
Hold the dose button down until the dose counter returns to 0 after the injection. 
Nakon injekcije, držite gumb za doziranje pritisnutim sve dok se brojčanik doze ne vrati na 0.
Rate ratio: 0.60 [0.48; 0.76] 
Omjer stopa: 0,60 [0,48; 0,76]
General effects from diabetes treatment • Too low blood sugar (hypoglycaemia) 
• Preniska razina šećera u krvi (hipoglikemija)
Difference: -0.05 [-0.45; 0.35] 
Razlika: -0,05 [-0,45; 0,35]5
Instructions on how to use Tresiba 200 units/mL solution for injection in pre-filled pen (FlexTouch) 
Upute za uporabu Tresiba 200 jedinica/ml otopine za injekciju u napunjenoj brizgalici (FlexTouch)
What Tresiba looks like and contents of the pack Tresiba is presented as a clear and colourless solution for injection in a pre-filled pen (600 units per 3 mL). 
Kako Tresiba izgleda i sadržaj pakiranja Tresiba dolazi u obliku bistre i bezbojne otopine za injekciju u napunjenoj brizgalici (600 jedinica u
Always use the dose counter and the dose pointer to see how many units you have selected before injecting the insulin. 
Prije injiciranja inzulina, uvijek koristite brojčanik doze i pokazivač doze da provjerite koliko ste jedinica odabrali.
MARKETING AUTHORISATION NUMBER EU/1/12/807/015 6 pens of 3 mL 
12. BROJ ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/12/807/015 6 brizgalica od 3 ml
Instructions on how to use Tresiba 100 units/mL solution for injection in pre-filled pen (FlexTouch) 
Upute za uporabu Tresiba 100 jedinica/ml otopine za injekciju u napunjenoj brizgalici (FlexTouch)
Can be stored in a refrigerator (2°C - 8°C). 
Može se čuvati u hladnjaku (2°C - 8°C).
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS LABEL (100 units/mL cartridge (Penfill)) 
PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE NALJEPNICA (100 jedinica/ml uložak (Penfill))
Avoidance of medication errors 
- Prijavljivanje medikacijskih pogrešaka ili bilo kojih nuspojava.
In children, care should be taken to match insulin doses (especially in basal-bolus regimens) with food intake and physical activities in order to minimise the risk of hypoglycaemia. 
Doze inzulina u djece potrebno je oprezno uskladiti (osobito u sklopu bazal-bolus inzulinske terapije)
Nocturnal severe2 
Teška noćna hipoglikemija2
• Check the name and strength on the label to make sure it is Tresiba 100 units/mL. 
• Provjerite naziv i jačinu na naljepnici kako biste bili sigurni da je to Tresiba 100 jedinica/ml.
Tresiba 200 units/mL solution for injection in pre-filled pen Solution for injection (FlexTouch). 
Tresiba 200 jedinica/ml otopina za injekciju u napunjenoj brizgalici Otopina za injekciju (FlexTouch).
Name and address of the manufacturer responsible for batch release 
PROIZVOĐAČI BIOLOŠKЕ DJELATNЕ TVARI I PROIZVOĐAČ ODGOVORAN ZA PUŠTANJE SERIJE LIJEKA U PROMET
MARKETING AUTHORISATION NUMBER EU/1/12/807/005 10 pens of 3 mL 
12. BROJ ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/12/807/005 10 brizgalica od 3 ml
The patient should discard the needle after each injection. 
Nakon svakog injiciranja, bolesnik treba zbrinuti iglu.
See your delivery system manual for further instructions. 
Za dodatne informacije pročitajte Upute za uporabu Vašeg pomagala za primjenu inzulina.
Each pre-filled pen contains 600 units of insulin degludec in 3 mL solution. 
Jedna napunjena brizgalica sadrži 600 jedinica degludek inzulina u 3 ml otopine.
Tresiba 100 units/mL solution for injection in pre-filled pen Tresiba 100 units/mL packaging and label are light green. 
Tresiba 100 jedinica/ml otopina za injekciju u napunjenoj brizgalici Pakiranje i naljepnica lijeka Tresiba 100 jedinica/ml su svjetlozelene boje.
PHARMACEUTICAL FORM AND CONTENTS Solution for injection (FlexTouch) Multipack: 10 (2 packs of 5) 3 mL pre-filled pens 
Višestruko pakiranje: 10 (2 pakiranja po 5) napunjenih brizgalica od 3 ml
Tresiba 200 units/mL solution for injection in pre-filled pen Tresiba 200 units/mL packaging and label are dark green with striping with a red box highlighting the formulation strength. 
Pakiranje i naljepnica lijeka Tresiba 200 jedinica/ml su tamnozelene boje s prugama, a jačina formulacije istaknuta je crvenim okvirom.
Tresiba 100 units/mL solution for injection in pre-filled pen Before first use: 
Tresiba 100 jedinica/ml otopina za injekciju u napunjenoj brizgalici Prije prve uporabe:
Tresiba 100 units/mL solution for injection in cartridge 3 mL solution in a cartridge (type 1 glass) with a plunger (halobutyl) and a laminate rubber sheet (halobutyl/polyisoprene) in a carton. 
Tresiba 100 jedinica/ml otopina za injekciju u ulošku 3 ml otopine u ulošku (staklo tipa 1) s klipom (halobutil) i pokrovom od laminirane gume (halobutil/poliizopren) u kutiji.
Keep cartridges in the outer carton in order to protect from light. 
Uloške čuvati u vanjskoj kutiji radi zaštite od svjetlosti.
*Statistically significant a Confirmed hypoglycaemia was defined as episodes confirmed by plasma glucose <3.1 mmol/L or by the patient needing third party assistance. 
*Statistički značajno a Potvrđena hipoglikemija definirana je kao epizoda potvrđena razinom glukoze u plazmi < 3,1 mmol/l ili time što je bolesniku potrebna pomoć druge osobe.
• Check the name and strength on the label of your pen to make sure that it contains Tresiba 200 units/mL. 
• Provjerite naziv i jačinu na naljepnici Vaše brizgalice kako biste bili sigurni da sadrži lijek Tresiba 200 jedinica/ml.
Stop using Tresiba and see a doctor straight away if the reactions become serious. 
Ako reakcije postanu ozbiljnije, prestanite primjenjivati lijek Tresiba i odmah posjetite liječnika.
Favours insulin glargine 
U korist glargin inzulina
No safety issues were identified with Tresiba with respect to adverse events and standard safety parameters. 
Što se tiče nuspojava i standardnih sigurnosnih pokazatelja nisu identificirana sigurnosna pitanja s lijekom Tresiba.
INFORMATION IN BRAILLE Tresiba pre-filled pen 100 units/mL 
Tresiba napunjena brizgalica 100 jedinica/ml
Pack sizes of 1 (with or without needles), 2 (without needles), 3 (without needles), 5 (without needles) and multipack of 6 (2 x 3) (without needles) pre-filled pens of 3 mL. 
Veličine pakiranja: 1 (sa ili bez igala), 2 (bez igala), 3 (bez igala), 5 (bez igala) i višestruko pakiranje koje sadrži 6 (2 x 3) (bez igala) napunjenih brizgalica od 3 ml.
Tresiba 100 units/mL solution for injection in pre-filled pen Solution for injection (FlexTouch). 
Tresiba 100 jedinica/ml otopina za injekciju u napunjenoj brizgalici Otopina za injekciju (FlexTouch).
Pack sizes of 1 (with or without needles), 5 (without needles) and multipack of 10 (2 x 5) (without needles) pre-filled pens of 3 mL. 
Veličine pakiranja: 1 (sa ili bez igala), 5 (bez igala) i višestruko pakiranje koje sadrži 10 (2 x 5) (bez igala) napunjenih brizgalica od 3 ml.