natgillin/translations-raw huggingface dataset:
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.
Tresiba 200 enot/ml raztopina za injiciranje v napolnjenem injekcijskem peresniku Škatla in nalepka zdravila Tresiba 200 enot/ml sta temno zelene barve s črtastim predelom, jakost je navedena v rdečem okencu.
The total glucose-lowering effect is comparable for Tresiba 100 units/mL and 200 units/mL after administration of the same doses of the two products.
Celotni učinek na znižanje koncentracije glukoze je po uporabi enakih odmerkov zdravila Tresiba 100 enot/ml in 200 enot/ml podoben.
Ratio: 0.75 [0.58; 0.99]
Razmerje: 0,75 [0,58;0,99]
End of trial Mean change
Konec preskušanja
The educational pack should contain: - Direct Healthcare Professional Communication letter as described below; - Summary of Product Characteristics and Package Leaflet; - Poster for display in pharmacies/diabetic units; - Patient Brochures.
- plakat, ki bo izobešen v lekarnah/diabetoloških enotah, - brošure za bolnike.
Your pen is designed to be used with NovoTwist or NovoFine single-use disposable needles up to a length of 8 mm.
NovoTwist ali NovoFine za enkratno uporabo, dolžine do 8 mm.
• Make sure the dose counter shows 0 before you start.
3 Izberite odmerek • Preden začnete se prepričajte, da števec odmerka kaže 0.
With Tresiba, hypersensitivity (manifested with swelling of tongue and lips, diarrhoea, nausea, tiredness and itching) and urticaria were reported rarely.
Pri zdravilu Tresiba so o preobčutljivosti (ki se kaže v obliki otekanja jezika in ustnic, driske, navzeje,
Ratio: 0.64 [0.56; 0.73]
Razmerje: 0,64 [0,56; 0,73]
- The 200 units/mL pre-filled pen delivers 2-160 units in steps of 2 units.
- Napolnjeni injekcijski peresnik 200 enot/ml omogoča aplikacijo od 2 do 160 enot v korakih po 2 enoti.
Do not count the pen clicks to select the dose; - Check how many units were selected before injecting the insulin; - The dose counter shows the number of units regardless of strength and no dose conversion should be done; - Reporting of medication errors or any side effects.
- da števec odmerkov kaže število enot ne glede na jakost in da se odmerkov ne sme pretvarjati, - da je treba prijaviti napake z zdravilom in vse neželene učinke.
Tresiba 200 units/mL solution for injection in pre-filled pen Before first use:
Tresiba 200 enot/ml raztopina za injiciranje v napolnjenem injekcijskem peresniku Pred prvo uporabo:
Example
(primer)
Detailed instructions accompanying the delivery system must be followed.
Upoštevati je treba podrobno navodilo,
The half-life after subcutaneous administration of Tresiba is determined by the rate of absorption from the subcutaneous tissue.
Hitrost absorpcije iz podkožnega tkiva je tista, ki določa razpolovni čas po subkutani uporabi zdravila Tresiba.
You may see a drop of insulin at the needle tip after injecting.
Po injiciranju lahko na konici igle vidite kapljico insulina.
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)).
Delovanje zdravila Tresiba so preiskusili v odprtih preskušanjih pri bolnikih s sladkorno boleznijo tipa 1 (preglednica 3), bolnikih, ki še niso prejemali insulina (uvedba insulinskega zdravljenja pri sladkorni bolezni tipa 2, preglednica 4) in pri bolnikih, ki so že uporabljali insulin (intenziviranje insulinskega zdravljenja pri sladkorni bolezni tipa 2, preglednica 5), in sicer tako odmerjanje vsak dan ob istem času kot tudi prilagodljivo odmerjanje (preglednica 6).
Tresiba 100 units/mL solution for injection in pre-filled pen Before first use:
Tresiba 100 enot/ml raztopina za injiciranje v napolnjenem injekcijskem peresniku Pred prvo uporabo:
Ratio: 1.10 [0.79; 1.52]
Razmerje: 1,10 [0,79;1,52] 6
1 Prepare your pen
1 Pripravite injekcijski peresnik
• Low blood sugar (hypoglycaemia) - if your blood sugar is too low, follow the guidance for low blood sugar in section 4.
• nizek krvni sladkor (hipoglikemija); če se vam koncentracija krvnega sladkorja preveč zniža,
Tresiba 200 units/mL solution for injection in pre-filled pen One pre-filled pen contains 600 units of insulin degludec in 3 mL solution.
Tresiba 200 enot/ml raztopina za injiciranje v napolnjenem injekcijskem peresniku En napolnjen injekcijski peresnik vsebuje 600 enot insulina degludek v 3 ml raztopine.
Nocturnal severe2
Huda nočna2
Inform your doctor immediately if you experience signs of heart failure such as unusual shortness of breath, rapid increase in weight or localised swelling (oedema).
Če občutite znake srčnega popuščanja, npr. nenavadno kratka sapa, hitro pridobivanje telesne mase ali lokalizirano otekanje (edem), nemudoma obvestite zdravnika.
HbA1c (%) End of trial Mean change
HbA1c (%) Izhodišče
Difference: -0.05 [-0.45; 0.35]
Razlika: 0,05 [-0,45; -0,35] 5
Odds ratio: 0.73 [0.60; 0.89]
Razmerje obetov: 0,73 [0,60; 0,89]
Rate ratio: 0.60 [0.48; 0.76]
Razmerje pojavnosti: 0,60 [0,48; 0,76]
- The 100 units/mL pre-filled pen delivers 1-80 units in steps of 1 unit.
- Napolnjeni injekcijski peresnik 100 enot/ml omogoča aplikacijo od 1 do 80 enot v korakih po 1 enoto.
Ratio: 0.58 [0.46; 0.74]
Razmerje: 0,58 [0,46; 0,74]
Tresiba 100 units/mL solution for injection in pre-filled pen 3 mL solution in a cartridge (type 1 glass) with a plunger (halobutyl) and a laminate rubber sheet (halobutyl/polyisoprene) contained in a pre-filled multidose disposable pen made of polypropylene.
Tresiba 100 enot/ml raztopina za injiciranje v napolnjenem injekcijskem peresniku 3 ml raztopine v injekcijskem vložku (steklo tipa 1) z batom (halobutil) in plastjo laminirane gume (halobutil/poliizopren) v napolnjenem večodmernem injekcijskem peresniku (polipropilen) za enkratno uporabo.
Keep cartridges in the outer carton in order to protect from light.
Injekcijske vložke shranjujte v zunanji ovojnini za zagotovitev zaščite pred svetlobo.
How to store Tresiba
Shranjevanje zdravila Tresiba
There is no clinically relevant development of insulin antibodies after long-term treatment with Tresiba.
b Pojavi od 16. tedna Po dolgotrajnem zdravljenju z zdravilom Tresiba ni klinično pomembnega razvoja protiteles proti insulinu.
The dose steps, however, differ between the two strengths of Tresiba.
Za obe jakosti je odmerek naveden v enotah, vendar se odmerni koraki razlikujejo med dvema jakostma zdravila Tresiba.
End of treatment FPG (mmol/L)
Glukoza v plazmi na tešče (mmol/l)
Your pen is a pre-filled dial-a-dose insulin pen containing 300 units of insulin.
Vaš injekcijski peresnik je napolnjen insulinski injekcijski peresnik z gumbom za nastavitev odmerka, ki vsebuje 300 enot insulina.
Tresiba 100 units/mL solution for injection in pre-filled pen One pre-filled pen contains 300 units of insulin degludec in 3 mL solution.
Tresiba 100 enot/ml raztopina za injiciranje v napolnjenem injekcijskem peresniku En napolnjen injekcijski peresnik vsebuje 300 enot insulina degludek v 3 ml raztopine.
11 multinational clinical trials of 26 or 52 weeks' duration were conducted as controlled, open-label, randomised, parallel, treat-to-target trials exposing 4,275 patients to Tresiba (1,102 in type 1 diabetes mellitus and 3,173 in type 2 diabetes mellitus).
V teh preskušanjih je zdravilo Tresiba prejemalo 4.275 bolnikov (1.102 s sladkorno boleznijo tipa 1 in 3.173 s sladkorno boleznijo tipa 2).
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).
Zdravilo Tresiba je na voljo kot bistra in brezbarvna raztopina za injiciranje v injekcijskem vložku (300 enot v 3 ml).
Discard the needle safely after each injection
Injekcijsko iglo po vsakem injiciranju varno zavrzite.
• you start being sick (vomiting)
• slabost (bruhanje),
Warnings and precautions Talk to your doctor, pharmacist or nurse before using Tresiba.
Pred začetkom uporabe zdravila Tresiba se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
The insulin degludec glucose-lowering action at steady state shows four times lower day-to-day variability in terms of Coefficients of Variation (CV) for the glucose-lowering effect during 0-24 hours (AUCGIR,τ,SS) and 2-24 hours (AUCGIR2-24h,SS) as compared to insulin glargine, see Table 1.
znižanja koncentracije glukoze v 0-24 urah (AUCGIR,τ,SS) in v 2-24 urah (AUCGIR2-24h,SS), glejte preglednico 1.
General effects from diabetes treatment • Too low blood sugar (hypoglycaemia)
• Prenizek krvni sladkor (hipoglikemija)
The pre-filled pen 200 units/mL can provide a dose of 2-160 units in one injection in steps of 2 units.
Napolnjen injekcijski peresnik z 200 enotami/ml lahko injicira 2-160 enot v eni injekciji, v korakih po
• To see precisely how much insulin is left, use the dose counter: Turn the dose selector until the dose counter stops.
• Če želite videti, koliko je še insulina, uporabite števec odmerka:
Rate of severe or BG confirmed symptomatic hypoglycaemia3,5 Maintenance period4
Delež hude hipoglikemije3 Vzdrževalno obdobje4
*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.
*Statistično značilno a Potrjena hipoglikemija je bila opredeljena kot potrjena koncentracija glukoze v plazmi < 3,1 mmol/l ali potreba po pomoči druge osebe.
• High blood sugar (hyperglycaemia) - if your blood sugar is too high, follow the guidance for high blood sugar in section 4.
• visok krvni sladkor (hiperglikemija); če se vam koncentracija krvnega sladkorja preveč zviša,
“Tresiba 100 units/mL” or “Tresiba 200 units/mL” is clearly marked on the pen label and packaging.
Na nalepki na injekcijskem peresniku in ovojnini je jasno označeno “Tresiba 100 enot/ml” ali “Tresiba 200 enot/ml”.
Type 1 + Type 2 diabetes mellitus (pooled) Maintenance period b
Sladkorna bolezen tipa 1 in tipa 2 (kumulativno)
Patients must visually verify the dialled units on the dose counter of the pen.
Bolniki morajo pogledati števec odmerka na injekcijskem peresniku, da se prepričajo, da so izbrali željeno število enot.
METHOD AND ROUTE OF ADMINISTRATION
IME ZDRAVILA IN POT UPORABE
Hydrochloric acid (for pH adjustment) Sodium hydroxide (for pH adjustment) Water for injections
FARMACEVTSKI PODATKI 6.1 Seznam pomožnih snovi glicerol metakrezol fenol cinkov acetat klorovodikova kislina (za uravnavanje pH) natrijev hidroksid (za uravnavanje pH) voda za injekcije
5 units selected
izbranih 5 enot primera izbranih 24 enot
• Do not use a syringe to remove the solution from the pen to avoid dosing errors and potential overdose.
• Da bi se izognili napakam pri odmerjanju in morebitnemu prevelikemu odmerjanju, ne uporabite injekcijske brizge, da bi z njo izvlekli raztopino iz injekcijskega peresnika.
Each pre-filled pen contains 600 units of insulin degludec in 3 mL solution.
En napolnjen injekcijski peresnik vsebuje 600 enot insulina degludek v 3 ml raztopine.
The pre-filled pen 100 units/mL can provide a dose of 1-80 units in one injection in steps of 1 unit.
Napolnjen injekcijski peresnik s 100 enotami/ml lahko injicira 1-80 enot v eni injekciji, v korakih po
Tresiba can be used with meal-related rapid-acting insulin products.
Zdravilo Tresiba se lahko uporablja tudi skupaj s hitrodelujočim insulinom, ki se ga injicira ob obroku.
If you drink alcohol, your need for insulin may change.
Zdravilo Tresiba skupaj z alkoholom Če pijete alkohol, se vam potreba po insulinu lahko spremeni, kajti koncentracija krvnega sladkorja se vam lahko poveča ali zmanjša.
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.
Škatla in nalepka zdravila Tresiba 100 enot/ml sta svetlo zelene barve, škatla in nalepka zdravila Tresiba 200 enot/ml pa temno zelene barve s črtastim predelom, jakost je navedena v rdečem okencu.
Non-fatal Stroke
Neželeni učinek
Can be stored in a refrigerator (2°C - 8°C).
Shranjujete lahko tudi v hladilniku (2 °C - 8 °C).
• oral contraceptives (birth control pills)
• danazol (zdravilo, ki se uporablja za zdravljenje endometrioze), • peroralne kontraceptive (tablete za preprečevanje zanositve),
Pack sizes of 1 (with or without needles), 2 (without needles), 3 (without needles), 5 (without needles) and multipack containing 6 (2 packs of 3) (without needles) pre-filled pens.
Pakiranja z 1 (z iglami ali brez), 2 (brez igel), s 3 (brez igel) ali s 5 (brez igel) in skupno pakiranje s 6 (2 škatli po 3, brez igel) napolnjenimi injekcijskimi peresniki.
Hypoglycaemia (too low blood sugar) may occur very commonly with insulin treatment (may affect more than 1 in 10 people).
Hipoglikemija (prenizek krvni sladkor) je zelo pogost neželeni učinek pri zdravljenju z insulinom
The pen can dial up to a maximum of 160 units.
Z injekcijskim peresnikom lahko izberete največ 160 enot.
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 enot/ml raztopina za injiciranje v napolnjenem injekcijskem peresniku Tresiba 200 enot/ml raztopina za injiciranje v napolnjenem injekcijskem peresniku
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).
Zdravilo Tresiba je na voljo kot bistra in brezbarvna raztopina za injiciranje v napolnjenem injekcijskem peresniku (600 enot v 3 ml).
• Always keep your pen with you.
• Injekcijski peresnik vedno nosite s seboj.
• Check the name and strength on the label of your pen to make sure that it contains Tresiba 200 units/mL.
• Preverite ime in jakost na nalepki injekcijskega peresnika, da se prepričate, da res vsebuje zdravilo Tresiba 200 enot/ml.
Tresiba 100 units/mL solution for injection in pre-filled pen Tresiba 100 units/mL packaging and label are light green.
Tresiba 100 enot/ml raztopina za injiciranje v napolnjenem injekcijskem peresniku Škatla in nalepka zdravila Tresiba 100 enot/ml sta svetlo zelene barve.
Caution: One step equals 2 units - the pen shows the dose
Pozor: En odmerni korak predstavlja 2 enoti.
6 units selected
izbranih 6 enot primera izbranih 24 enot
4 Confirmed hypoglycaemia was defined as episodes confirmed by plasma glucose <3.1 mmol/L or by the patient needing third party assistance.
4 Potrjena hipoglikemija je bila opredeljena kot potrjena koncentracija glukoze v plazmi < 3,1 mmol/l ali potreba po pomoči druge osebe.
For both strengths, the needed dose is dialled in units.
Zdravilo Tresiba je na voljo v dveh jakostih in pri obeh se potrebni odmerek meri v enotah.
1 In a once-daily regimen + insulin aspart to cover mealtime insulin requirements 2 In a once-daily regimen ± OADs (any combination of metformin, dipeptidyl peptidase-4 inhibitor, alpha-glucosidase inhibitor, thiazolidinediones, and sodium glucose cotransporter-2 inhibitor) 3 Per patient year of exposure
1 Shema enkrat na dan + insulin aspart za kritje potreb po insulinu ob obrokih ± metformin ± pioglitazon 2 Shema enkrat na dan ± metformin, sulfonilsečnina/glinid ± pioglitazon 3 Potrjena hipoglikemija je bila opredeljena kot potrjena koncentracija glukoze v plazmi < 3,1 mmol/l ali potreba po pomoči druge osebe.
Each pre-filled pen contains 300 units of insulin degludec in 3 mL solution.
En napolnjen injekcijski peresnik vsebuje 300 enot insulina degludek v 3 ml raztopine.
Keep the cap on the pen in order to protect from light.
Vložke shranjujte v škatli za zagotovitev zaščite pred svetlobo.
2 Confirmed hypoglycaemia was defined as episodes confirmed by plasma glucose <3.1 mmol/L or by the patient needing third party assistance.
2 Potrjena hipoglikemija je bila opredeljena kot potrjena koncentracija glukoze v plazmi < 3,1 mmol/l ali potreba po pomoči druge osebe.
This makes sure that the insulin flows.
To zagotavlja pretok raztopine.
Table 2 Hypoglycaemia meta-analysis outcomes
Izidi metaanalize hipoglikemij
Instructions on how to use Tresiba 200 units/mL solution for injection in pre-filled pen (FlexTouch)
Navodila za uporabo zdravila Tresiba 200 enot/ml raztopina za injiciranje v napolnjenem injekcijskem peresniku (FlexTouch)
Table 4 Results from open-label clinical trials in insulin naïve type 2 diabetes mellitus (insulin initiation)
Rezultati odprtih kliničnih preskušanj pri bolnikih s sladkorno boleznijo tipa 2, ki še niso prejemali insulina (uvedba insulinskega zdravljenja)
Instructions on how to use Tresiba 100 units/mL solution for injection in pre-filled pen (FlexTouch)
Navodila za uporabo zdravila Tresiba 100 enot/ml raztopina za injiciranje v napolnjenem injekcijskem peresniku (FlexTouch)
• Measure your blood sugar if possible and rest. You may need to measure your blood sugar more than once, as with all basal insulin products improvement from the period of low blood sugar may be delayed.
Meritve boste morda morali ponoviti večkrat, saj do izboljšanja lahko pride z zakasnitvijo, kot pri uporabi vseh zdravil z bazalnim insulinom.
• The dose counter shows the dose dialled in units.
Izbirnik odmerka kaže odmerek v enotah, ne glede na koncentracijo zdravila.
Tresiba 100 units/mL solution for injection in pre-filled pen Solution for injection (FlexTouch).
Tresiba 100 enot/ml raztopina za injiciranje v napolnjenem injekcijskem peresniku raztopina za injiciranje (FlexTouch)
Insulin glargine (100 units/mL)1
insulin glargin (100 enot/ml)1
Insulin glargine (100 units/mL)2
insulin glargin (100 enot/ml)2
Tresiba 200 units/mL solution for injection in pre-filled pen Solution for injection (FlexTouch).
Tresiba 200 enot/ml raztopina za injiciranje v napolnjenem injekcijskem peresniku raztopina za injiciranje (FlexTouch)
• angiotensin converting enzyme (ACE) inhibitors, for some heart problems or high blood pressure.
• zaviralce angiotenzinske konvertaze (zaviralce ACE (angiotensin converting enzyme))
• Check the name and strength on the label to make sure it is Tresiba 100 units/mL.
• Preverite ime in jakost na nalepki, da se prepričate, da imate res zdravilo Tresiba 100 enot/ml.
The dose counter shows the number of units regardless of strength and no dose conversion should be done when transferring a patient to a new strength.
Zato se pri prehodu bolnika na drugačno koncentracijo zdravila ne sme pretvarjati enot.
• Check the name and strength on the label of your pen to make sure that it contains Tresiba 100 units/mL.
• Preverite ime in jakost na nalepki injekcijskega peresnika, da se prepričate, da res vsebuje zdravilo Tresiba 100 enot/ml.
Favours Tresiba
V prid zdravilu Tresiba
Each cartridge contains 300 units of insulin degludec of insulin in 3 ml solution.
En injekcijski vložek vsebuje 300 enot insulina degludek v 3 ml raztopine.
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.
Pakiranja z 1 (z iglami ali brez), 2 (brez igel), s 3 (brez igel) ali s 5 (brez igel) in skupno pakiranje s 6 (2 x 3, brez igel) napolnjenimi injekcijskimi peresniki po 3 ml. Na trgu morda ni vseh navedenih pakiranj.
Pack sizes of 1 (with or without needles), 5 (without needles) and multipack containing 10 (2 packs of 5) (without needles) pre-filled pens.
Pakiranja z 1 (z iglami ali brez), s 5 (brez igel) in skupno pakiranje z 10 (2 škatli po 5, brez igel) napolnjenimi injekcijskimi peresniki.
Type 2 diabetes mellitus Maintenance period b
Vzdrževalno obdobje b
• Never share your pen with other people.
• Injekcijskega peresnika si ne smete deliti z drugimi.
INFORMATION IN BRAILLE Tresiba pre-filled pen 100 units/mL
Tresiba peresnik 100 enot/ml
Dose selector Dose button
FlexTouch potisni gumb z 2
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON (100 units/mL cartridge (Penfill))
PODATKI NA ZUNANJI OVOJNINI ŠKATLA (Injekcijski vložek 100 enot/ml (Penfill))
Clear, colourless, neutral solution.
Uporabite le bistro, brezbarvno raztopino.
Injection site reactions Uncommon Peripheral oedema
Bolezni imunskega sistema redki preobčutljivost urtikarija
Tresiba 100 units/mL solution for injection in cartridge insulin degludec
Tresiba 100 enot/ml raztopina za injiciranje insulin degludek
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.
3 ml raztopine v injekcijskem vložku (steklo tipa 1) z batom (halobutil) in plastjo laminirane gume (halobutil/poliizopren) v škatli.
Table 3 Results from open-label clinical trials in type 1 diabetes mellitus 52 weeks of treatment
Rezultati odprtih kliničnih preskušanj pri sladkorni bolezni tipa 1
STATEMENT OF ACTIVE SUBSTANCE One cartridge contains 300 units of insulin degludec in 3 mL solution 1 mL solution contains 100 units of insulin degludec (equivalent to 3.66 mg)
1 ml raztopine vsebuje 100 enot insulina degludek (kar ustreza 3,66 mg),
Tresiba 200 units/mL solution for injection in pre-filled pen 3 mL solution in a cartridge (type 1 glass) with a plunger (halobutyl) and a laminate rubber sheet (halobutyl/polyisoprene) contained in a pre-filled multidose disposable pen made of polypropylene.
Tresiba 200 enot/ml raztopina za injiciranje v napolnjenem injekcijskem peresniku 3 ml raztopine v injekcijskem vložku (steklo tipa 1) z batom (halobutil) in plastjo laminirane gume
STATEMENT OF ACTIVE SUBSTANCE One pre-filled pen contains 600 units of insulin degludec in 3 mL solution 1 mL solution contains 200 units of insulin degludec (equivalent to 7.32 mg)
1 ml raztopine vsebuje 200 enot insulina degludek (kar ustreza 7,32 mg),
Basal only therapy in previously insulin-naïve
Samo bazalno zdravljenje pri bolnikih, ki še niso prejemali insulina
Difference: -0.13 [-0.29; 0.03]
Razlika: -0,13 [-0,29; 0,03] 5
Always keep the cap on the pen when you are not using it in order to protect it from light.
Kadar injekcijskega peresnika ne uporabljate, naj bo vedno pokrit s pokrovčkom za zagotovitev zaščite pred svetlobo.
MARKETING AUTHORISATION NUMBER EU/1/12/807/005 10 pens of 3 mL
EU/1/12/807/005 10 injekcijskih peresnikov s 3 ml
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS LABEL (100 units/mL cartridge (Penfill))
NALEPKA (Injekcijski vložek 100 enot/ml (Penfill))
MARKETING AUTHORISATION NUMBER EU/1/12/807/015 6 pens of 3 mL
EU/1/12/807/015 6 injekcijskih peresnikov s 3 ml
1 Once-daily regimen + insulin aspart to cover mealtime insulin requirements ± metformin ± pioglitazone 2 Once-daily regimen ± metformin SU/glinide ± pioglitazone
1 Shema enkrat na dan + insulin aspart za kritje potreb po insulinu ob obrokih.
Eye disorder
Očesne bolezni
Tresiba 200 units/mL solution for injection in pre-filled pen insulin degludec
Tresiba 200 enot/ml raztopina za injiciranje v napolnjenem injekcijskem peresniku insulin degludek
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON (200 units/mL pre-filled pen (FlexTouch))
PODATKI NA ZUNANJI OVOJNINI ŠKATLA (Napolnjen injekcijski peresnik 200 enot/ml (FlexTouch))
NAME OF THE MEDICINAL PRODUCT Tresiba 200 units/mL solution for injection in pre-filled pen insulin degludec
Navodilo za uporabo Tresiba 200 enot/ml raztopina za injiciranje v napolnjenem injekcijskem peresniku insulin degludek
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON (100 units/mL pre-filled pen (FlexTouch))
PODATKI NA ZUNANJI OVOJNINI ŠKATLA (Napolnjen injekcijski peresnik 100 enot/ml (FlexTouch))
The dose is provided in half the volume of 100 units/mL basal insulin products.
Odmerek se injicira v polovičnem volumnu raztopine v primerjavi z ostalimi bazalnimi insulinskimi zdravili s koncentracijo 100 enot/ml.