natgillin/translations-raw huggingface dataset:
As observed in euglycaemic clamp studies in patients with type 1 diabetes, the glucose lowering effect of Toujeo was more stable and prolonged in comparison with insulin glargine 100 units/ml after subcutaneous injection.
Evglikemične clamp študije pri bolnikih s sladkorno boleznijo tipa 1 so pokazale, da je po subkutanem injiciranju vpliv zdravila Toujeo na znižanje glukoze v krvi stabilnejši in dolgotrajnejši kot z insulinom glargin 100 enot/ml.
Each cartridge contains 1.5 ml solution.
En vložek vsebuje 1,5 ml raztopine.
Adherence of the patient to the dose and dietary regimen, correct insulin administration and awareness of hypoglycaemia symptoms are essential to reduce the risk of hypoglycaemia.
Za zmanjšanje tveganja za hipoglikemijo mora bolnik nujno upoštevati shemo odmerjanja in načrt prehrane, pravilno dajati insulin in poznati simptome hipoglikemije.
- That the switch from one insulin therapy to another should only be done when prescribed by their healthcare provider; - That the dose newly recommended by their healthcare provider should always be followed;
- Prehod z enega insulinskega zdravljenja na drugega je treba opraviti le, če ga je predpisal zdravnik.
• If your blood sugar falls too low, you may pass out (become unconscious).
• Če se vam krvni sladkor preveč zniža, se lahko onesvestite (izgubite zavest).
It delivers doses of 1-80 units per injection, in steps of 1 unit.
Odmerja odmerke od 1 do 80 enot na injekcijo v korakih po 1 enoto.
In patients with type 1 diabetes, the incidence of hypoglycaemia was similar in patients treated with Toujeo compared to insulin glargine 100 units/ml-treated patients (Table 3).
Pri bolnikih s sladkorno boleznijo tipa 1 je bila incidenca hipoglikemij podobna pri tistih, ki so dobivali zdravilo Toujeo, kot pri tistih, ki so dobivali insulin glargin 100 enot/ml (preglednica 3).
Each cartridge contains 3 ml solution.
En vložek vsebuje 3 ml raztopine.
Switch from Toujeo to other basal insulins
Prehod z zdravila Toujeo na druge bazalne insuline
It delivers doses of 2-160 units per injection, in steps of 2 units.
Odmerja odmerke od 2 do 160 enot na injekcijo v korakih po 2 enoti.
HYPERGLYCAEMIA AND HYPOGLYCAEMIA If you take insulin, you should always carry the following things with you:
Če uporabljate insulin, morate vedno s seboj nositi:
Insulin label must always be checked before each injection to avoid medication errors between Toujeo and other insulins (see section 6.6).
Da bi se izognili napakam pri uporabi zdravila zaradi zamenjave med zdravilom Toujeo in drugimi insulini, je treba pred vsakim injiciranjem vedno preveriti nalepko insulina (glejte poglavje 6.6).
Toujeo must not be drawn from the cartridge of the Toujeo SoloStar pre-filled pen or Toujeo DoubleStar pre-filled pen into a syringe or severe overdose can result (see section 4.4, 4.9 and 6.6).
Zdravila Toujeo se iz vložka napolnjenega injekcijskega peresnika SoloStar ali napolnjenega injekcijskega peresnika DoubleStar ne sme izvleči v injekcijsko brizgo, sicer lahko pride do hudega prevelikega odmerjanja (glejte poglavja 4.4, 4.9 in 6.6).
Nervous system disorders
Bolezni živčevja dizgevzija
[-0.090 to 0.174]
0,04 [-0,090 do 0,174]
To reduce the risk of hypoglycaemia, patients who are changing their basal insulin regimen from an insulin regimen with once daily Toujeo (insulin glargine 300 units/ml) to a once daily regimen with insulin glargine 100 units/ml should reduce their dose by 20%;
Bolniki, ki shemo bazalnega insulina spreminjajo z zdravila Toujeo (insulin glargin 300 enot/ml) enkrat na dan na insulin glargin 100 enot/ml enkrat na dan, morajo za zmanjšanje tveganja za hipoglikemijo odmerek zmanjšati za 20 %.
Toujeo is a basal insulin for once-daily administration at any time of the day, preferably at the same time every day.
Zdravilo Toujeo je bazalni insulin za uporabo enkrat na dan; uporabiti ga je mogoče kadar koli v teku dneva, po možnosti pa vsak dan ob istem času.
Insulin glargine
Merilo insulina
A new sterile needle must be attached before each injection.
Pred vsakim injiciranjem je treba namestiti novo sterilno iglo.
Each ml of the solution contains 300 units of insulin glargine (equivalent to 10.91 mg).
En ml raztopine vsebuje 300 enot insulina glargin (to ustreza 10,91 mg).
When given intravenously the elimination half-life of insulin glargine and human insulin were comparable.
Po intravenski uporabi je eliminacijski razpolovni čas insulina glargin primerljiv tistemu pri humanem insulinu.
For storage conditions after first opening of this medicinal product, see section 6.3.
Po prvi uporabi ali če bolnik injekcijski peresnik nosi s seboj za rezervo Za pogoje shranjevanja po prvem odprtju zdravila glejte poglavje 6.3. 6.5 Vrsta ovojnine in vsebina
Treatment in combination with Meal-time insulin analog+/-metformin
Zdravljenje v kombinaciji z insulinskim analogom ob obrokih +/- metforminom Neinsulinskimi antihiperglikemičnimi zdravili
After injection into the subcutaneous tissue, the acidic solution is neutralised leading to formation of a precipitate from which small amounts of insulin glargine are continuously released.
Nastane precipitat, iz katerega se trajno sprošča majhna količina insulina glargin.
No safety issues were identified with Toujeo with respect to adverse events and standard safety parameters.
Glede neželenih učinkov in standardnih varnostnih parametrov niso z zdravilom Toujeo ugotovili nobenih varnostnih težav.
• Thyroid hormones - for thyroid gland problems.
• Ščitnične hormone - za težave z žlezo ščitnico.
Always use this medicine exactly as your doctor has told you.
- Vedno je treba uporabljati odmerek, ki ga je na novo naročil zdravnik.
• Keep your pen and needles out of the sight and reach of children
• Peresnik in igle shranjujte nedosegljivo otrokom.
RR: 0.93 [0.88; 0.99]
RT: 0,93 [0,88; 0,99]
Toujeo dosed once daily showed similar reduction in HbA1c and FPG from baseline to week 26 compared to insulin glargine 100 units/mL.
Po 26 tednih je zdravilo Toujeo enkrat na dan v primerjavi z izhodiščem znižalo HbA1c in glukozo v plazmi na tešče podobno kot insulin glargin 100 enot/ml.
RR: 0.79 [0.67;0.93]
RT: 0,79 [0,67;0,93]
(such as acetylsalicylic acid).
propoksifen in salicilate (na primer acetilsalicilno kislino).
What Toujeo is and what it is used for What you need to know before you use Toujeo How to use Toujeo
Kaj je zdravilo Toujeo in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo Toujeo Kako uporabljati zdravilo Toujeo Možni neželeni učinki
Toujeo DoubleStar 24 months.
24 mesecev.
[-0.168 to 0.099]
-0,03 [-0,168 do 0,099]
RR: 0.89 [0.83; 0.96]
RT: 0,89 [0,83; 0,96]
If you use more than one insulin always ensure you use the right insulin by checking the insulin label before each injection.
Če uporabljate veš insulinov hkrati, je pred vsakim injiciranjem potrebno preveriti nalepko insulina.
• Never use a syringe to remove Toujeo from your SoloStar pre-filled pen.
• Nikoli ne uporabite brizge, da bi z njo jemali zdravilo Toujeo iz napolnjenega injekcijskega peresnika SoloStar.
If this occurs, you should increase the frequency of checking your blood sugar level and might need to administer additional insulin.
V takšnem primeru si morate pogosteje meriti koncentracijo glukoze v krvi in morda si boste morali injicirati dodaten insulin.
Visual impairment
Okence odmerka
The Toujeo SoloStar pre-filled pen can provide a dose of 1 to 80 units in one injection, in steps of 1 unit.
Napolnjeni injekcijski peresnik Toujeo SoloStar lahko odmeri od 1 do 80 enot v eni injekciji, v koraku po 1 enoto.
The dose window of the SoloStar pen shows the number of units of Toujeo to be injected.
Odmerno okence peresnika SoloStar kaže število enot zdravila Toujeo, ki bodo injicirane.
Number of patients treateda
Število zdravljenih bolnikova HbA1c
- change the needle (see STEP 6 and STEP 2),
• Zamenjajte iglo (glejte 6.
The percentage of patients with hyperglycaemic episodes with ketosis was lower for Toujeo versus insulin glargine 100 units/mL, 6.4% and 11.8%, respectively.
Odstotek bolnikov z obdobji hiperglikemije s ketozo je bil v skupini z zdravilom Toujeo manjši (6,4 %) kot v skupini z insulinom glarginom 100 enot/ml (11,8 %).
Dose selector
Izbirnik odmerka
Discard the pen after this time period.
Po tem obdobju injekcijski peresnik zavrzite.
Each pen contains 1.5 ml of solution for injection (equivalent to 450 units).
En injekcijski peresnik vsebuje 1,5 ml raztopine za injiciranje (to ustreza 450 enotam).
Diabetic population
Populacija sladkornih bolnikov
Switch between insulin glargine 100 units/ml and Toujeo
Prehod z insulina glargin 100 enot/ml na zdravilo Toujeo
Toujeo with alcohol
Zdravilo Toujeo skupaj z alkoholom
With Toujeo SoloStar pre-filled pen, a dose of 1-80 units per single injection, in steps of 1 unit, can be injected.
Z napolnjenim injekcijskim peresnikom Toujeo SoloStar je mogoče injicirati odmerek od 1 do 80 enot na injekcijo v koraku po 1 enoto.
Incidence (%) of confirmed nocturnalc hypoglycaemia (n/Total N)
Incidenca (%) potrjenih nočnihc hipoglikemij (n/celotni N) Od 9. tedna do konca obdobja študije
Handling needles
Ravnanje z iglami
Medical supervision with close metabolic monitoring is recommended during the switch and in the initial weeks thereafter.
Med prehodom in v prvih tednih po njem je priporočljiv zdravniški nadzor z natančnim nadzorom presnove.
Body weight affects the clearance of Toujeo in a nonlinear way.
Telesna masa nelinearno vpliva na očistek zdravila Toujeo.
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Z ZDRAVILOM Datum prve odobritve: 27. junij 2000
The insulin may not work very well.
Delovanje insulina se zato lahko poslabša.
If your blood sugar level falls too much you may pass out (become unconscious).
Če se vam koncentracija krvnega sladkorja preveč zniža, se lahko onesvestite (izgubite zavest).
The Toujeo DoubleStar pre-filled pen can provide a dose of 2 to 160 units per injection, in steps of 2 units.
Z napolnjenim injekcijskim peresnikom Toujeo DoubleStar je mogoče injicirati odmerek od 2 do160 enot na injekcijo v koraku po 2 enoti.
C Put the pen cap back on.
C Znova namestite pokrovček peresnika.
Each DoubleStar pen contains 3 ml of solution for injection (equivalent to 900 units).
En injekcijski peresnik DoubleStar vsebuje 3 ml raztopine za injiciranje (to ustreza 900 enotam).
SoloStar pen
Pokrovček peresnika
Table 1: Results from clinical trials in type 1 diabetes mellitus
Preglednica 1: Rezultati kliničnih preskušanj pri sladkorni bolezni tipa 1 26 tednov zdravljenja
The MAH is therefore requested to include the event cutaneous amyloidosis in the SmPC and PIL.
Imetnik dovoljenja za promet mora zato neželeni učinek "kožna amiloidoza" vključiti v povzetek glavnih značilnosti zdravila (SmPC) in navodilo za uporabo (PIL).
Type2 diabetes mellitus Patients previously Insulin naive or on basal insulin
Sladkorna bolezen tipa 2 Bolniki, ki prej še niso dobivali insulina ali so uporabljali bazalni insulin
Always attach a new sterile needle before each injection.
Pred vsakim injiciranjem vedno namestite novo sterilno iglo.
• make sure that you get the correct insulin dose.
• da boste zagotovili injiciranje pravilnega odmerka insulina.
• Too low blood sugar (hypoglycaemia).
Visok krvni sladkor (hiperglikemija)
In healthy subjects and diabetic patients, insulin serum concentrations indicated a slower and more prolonged absorption resulting in a flatter time-concentration profile after subcutaneous injection of Toujeo in comparison to insulin glargine 100 units/ml.
Koncentracija insulina v serumu pri zdravih preiskovancih in sladkornih bolnikih je po subkutani injekciji zdravila Toujeo v primerjavi z insulinom glargin 100 enot/ml pokazala počasnejšo in dolgotrajnejšo absorpcijo, zaradi česar je bilo gibanje koncentracije skozi čas mnogo bolj plosko.
Always keep the cap on the pen when you are not using it in order to protect from light.
Kadar peresnika ne uporabljate, naj ima vedno nameščen pokrovček za zagotovitev zaščite pred svetlobo.
How much to use
Koliko insulina uporabiti
• Test your blood sugar level and your urine for ketones as soon as you notice any of the above signs.
• Čim opazite katerega od naštetih znakov, izmerite sladkor v krvi in naredite preizkus za ketone v urinu.
In patients with proliferative retinopathy, particularly if not treated with photocoagulation, severe hypoglycaemic episodes may result in transient amaurosis.
Hude hipoglikemije lahko pri bolnikih s proliferativno retinopatijo povzročijo prehodno slepoto, zlasti če retinopatija ni zdravljena s fotokoagulacijo.
Each pen contains 1.5 ml of solution for injection, equivalent to 450 units.
En injekcijski peresnik vsebuje 1,5 ml raztopine za injiciranje; to ustreza 450 enotam.
Each ml contains 300 units insulin glargine* (equivalent to 10.91 mg).
KAKOVOSTNA IN KOLIČINSKA SESTAVA En mililiter vsebuje 300 enot insulina glargin* (to ustreza 10,91 mg).
Toujeo 300 units/ml SoloStar injection Toujeo 300 units/ml DoubleStar injection insulin glargine
Toujeo 300 enot/ml DoubleStar injekcije insulin glargin
Contact a doctor as soon as you feel ill or get an injury.
Če zbolite ali se poškodujete, se na zdravnika obrnite čim prej.
STEP 2: Attach a new needle
KORAK: Namestite novo iglo.
- Blood glucose monitoring by patients is needed during the switch and the initial weeks thereafter;
- Med prehodom in v prvih tednih po njem morajo bolniki spremljati glukozo v krvi.
Results from clinical trials demonstrated that the incidence of confirmed hypoglycaemia (at any time of the day and nocturnal) was lower in patients treated with Toujeo compared to insulin glargine 100 units/ml-treated patients, in patients with type 2 diabetes treated in combination with either non-insulin anti-hyperglycaemic medicinal product or mealtime insulin.
Pri sladkornih bolnikih tipa 2, ki so poleg dolgodelujočega insulina prejemali ali neinsulinska antihiperglikemična zdravila ali insulin ob obrokih, so rezultati kliničnih preskušanj dokazali nižjo incidenco potrjenih hipoglikemij (kadar koli v teku dneva in nočnih) pri tistih, ki so dobivali zdravilo Toujeo, kot pri tistih, ki so dobivali insulin glargin 100 enot/ml.
The dose window of the DoubleStar pen shows the number of units of Toujeo to be injected.
Odmerno okence peresnika DoubleStar kaže število enot zdravila Toujeo, ki bodo injicirane.
Other medicines and Toujeo
Druga zdravila in zdravilo Toujeo
Sanofi-Aventis Deutschland GmbH, D-65926 Frankfurt am Main, Germany
IMETNIK DOVOLJENJA ZA PROMET Z ZDRAVILOM Sanofi-Aventis Deutschland GmbH, D-65926 Frankfurt am Main, Nemčija
Read this first Toujeo SoloStar contains 300 units/ml insulin glargine in a 1.5 ml disposable prefilled pen
Zdravilo Toujeo SoloStar vsebuje 300 enot/ml insulina glargin v 1,5-ml napolnjenem injekcijskem peresniku, ki se ga po dokončani uporabi zavrže.
HbA1c
Število zdravljenih oseb (mZNZa) HbA1c
Combination of Toujeo with pioglitazone
Uporaba zdravila Toujeo skupaj s pioglitazonom
Switch from other basal insulins to Toujeo
Prehod z drugih bazalnih insulinov na zdravilo Toujeo
• Never use a syringe to remove Toujeo from your DoubleStar pen.
• Nikoli ne uporabite brizge, da bi z njo jemali zdravilo Toujeo iz napolnjenega injekcijskega peresnika DoubleStar.
Toujeo 300 units/ml solution for injection in a pre-filled pen (SoloStar) INSTRUCTIONS FOR USE
Zdravilo Toujeo 300 enot/ml raztopina z injiciranje v napolnjenem injekcijskem peresniku (SoloStar)
Lipohypertrophy Lipoatrophy
Bolezni kože in podkožja lipohipertrofija lipoatrofija kožna amiloidoza
1 step=2 units
KORAK in 2.
Toujeo 300 SoloStar Toujeo 300 DoubleStar
PODATKI V BRAILLOVI PISAVI Toujeo 300 DoubleStar
Each DoubleStar pen contains 3 ml of solution for injection, equivalent to 900 units.
En injekcijski peresnik DoubleStar vsebuje 3 ml raztopine za injiciranje; to ustreza 900 enotam.
Toujeo SoloStar 30 months.
30 mesecev.
• Never use a syringe to remove insulin from your pen.
• Nikdar ne odvzemajte insulina iz peresnika z injekcijsko brizgo.
Each pen contains 1.5 ml of solution, equivalent to 450 units.
En injekcijski peresnik vsebuje 1,5 ml raztopine; to ustreza 450 enotam.
The overall efficacy and safety of Toujeo (insulin glargine 300 units/ml) once-daily on glycaemic control was compared to that of once-daily insulin glargine 100 units/ml in open-label, randomised, active-control, parallel studies of up to 26 weeks of duration, including 546 patients with type 1 diabetes mellitus and 2,474 patients with type 2 diabetes mellitus (Table 1 and 2).
Celokupno učinkovitost in varnost zdravila Toujeo (insulin glargin 300 enot/ml) enkrat na dan na urejenost glikemije so primerjali z insulinom glargin 100 enot/ml enkrat na dan v odprtih, randomiziranih, z zdravilno učinkovino kontroliranih študijah vzporednih skupin.
- Never use a syringe to remove insulin from your pen.
- Nikdar ne odvzemajte insulina iz peresnika z injekcijsko brizgo.
Toujeo 300 units/ml SoloStar, solution for injection in a pre-filled pen Toujeo 300 units/ml DoubleStar, solution for injection in a pre-filled pen
Toujeo 300 enot/ml SoloStar raztopina za injiciranje v napolnjenem injekcijskem peresniku Toujeo 300 enot/ml DoubleStar raztopina za injiciranje v napolnjenem injekcijskem peresniku
This will change the way it works and may cause your blood sugar to become too low.
• Za injiciranje v veno - takšno injiciranje spremeni način delovanja zdravila in lahko povzroči, da se vam krvni sladkor preveč zniža.
Sanofi-Aventis Deutschland GmbH, D-65926 Frankfurt am Main, Germany.
Imetnik dovoljenja za promet z zdravilom in izdelovalec Sanofi-Aventis Deutschland GmbH, D-65926 Frankfurt am Main, Nemčija.
450 units per pen (SoloStar pen) 900 units per pen (DoubleStar pen)
900 enot na peresnik (DoubleStar peresnik)
Toujeo is a clear and colourless solution.
Zdravilo Toujeo je bistra in brezbarvna raztopina.
Each pen contains 3 ml of solution for injection, equivalent to 900 units.
En injekcijski peresnik vsebuje 3 ml raztopine za injiciranje; to ustreza 900 enotam.
The solution should be clear, colourless and water-like.
• Če so v insulinu delci - raztopina mora biti bistra, brezbarvna in po videzu kot voda.
Toujeo 300 units/ml SoloStar solution for injection in a pre-filled pen Toujeo 300 units/ml DoubleStar solution for injection in a pre-filled pen insulin glargine
Toujeo 300 enot/ml SoloStar raztopina za injiciranje v napolnjenem injekcijskem peresniku Toujeo 300 enot/ml DoubleStar raztopina za injiciranje v napolnjenem injekcijskem peresniku insulin glargin
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT
VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT 1,5 ml (SoloStar)
Meal-time insulin analog Meal-time insulin analog+/-metformin
Zdravljenje v kombinaciji z insulinskim analogom ob obrokih insulinskim analogom ob obrokih +/- metforminom neinsulinskimi antihiperglikemičnimi zdravili
The dose increment in Toujeo SoloStar is one unit and the dose increment in Toujeo DoubleStar is 2 units.
S peresnikom Toujeo SoloStar je mogoče odmerek povečevati po 1 enoto in s peresnikom Toujeo DoubleStar po 2 enoti.
Even numbers are shown in line with the dose pointer:
Kako odčitati odmerek v odmernem okencu Soda števila so prikazana kot uravnana s kazalnikom odmerka:
The dose window shows the number of units of Toujeo to be injected.
Odmerno okence kaže število enot zdravila Toujeo, ki bodo injicirane.
Multipack: 9 (3 packs of 3) pens
Skupno pakiranje: 6 (2 pakiranji po 3) injekcijskih peresnikov Skupno pakiranje: 9 (3 pakiranja po 3) injekcijskih peresnikov
Toujeo 300 units/ml DoubleStar solution for injection in a pre-filled pen insulin glargine
Toujeo 300 enot/ml DoubleStar, raztopina za injiciranje v napolnjenem injekcijskem peresniku insulin glargin
Toujeo is a long-acting insulin.
Zdravilo Toujeo je dolgodelujoč insulin.
Medication errors due to mix-up between insulins, particularly between longacting insulins and rapid-acting insulins have been reported.
Med uporabo drugih insulinov so poročali o napakah pri uporabi zdravila, zlasti o napakah, pri katerih so bili namesto dolgodelujočih insulinov pomotoma uporabljeni hitrodelujoči.
Insulin label must always be checked before each injection to avoid medication errors between Toujeo and other insulins.
Da bi se izognili napakam zdravljenja zaradi zamenjave med zdravilom Toujeo in drugimi insulini, je potrebno nalepko insulina vedno preveriti pred vsakim injiciranjem.
If you stop using Toujeo
Če ste prenehali jemati zdravilo Toujeo
Read this first Toujeo DoubleStar contains 300 units/ml insulin glargine in a 3 ml disposable prefilled pen
Zdravilo Toujeo DoubleStar vsebuje 300 enot/ml insulina glargin v 3-ml napolnjenem injekcijskem peresniku, ki se ga po dokončani uporabi zavrže.
C Pull off the outer needle cap. Keep this for later.
C Odstranite zunanji pokrovček igle.
Throwing your pen away
Kako zavreči peresnik
Close metabolic monitoring is recommended during the switch and in the initial weeks thereafter.
Med prehodom in v prvih tednih po njem je priporočljivo natančno spremljati presnovo.
Your blood sugar level may become too low (hypoglycaemia).
• Če ne jeste dovolj - koncentracija krvnega sladkorja se lahko preveč zniža (hipoglikemija).
Each DoubleStar pen delivers 2-160 units in steps of 2 units Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
1 odmerni korak= 2 enoti Pred uporabo preberite priloženo navodilo!
STEP 1: Check your pen
KORAK: Preverite injekcijski peresnik
How to read the dose window
Kako uporabljati zdravilo Toujeo
Toujeo 300 units/ml solution for injection in a pre-filled pen (DoubleStar) INSTRUCTIONS FOR USE
Zdravilo Toujeo 300 enot/ml raztopina z injiciranje v napolnjenem injekcijskem peresniku (DoubleStar)
60 units selected
Izbrani odmerek 4 enote
- That blood glucose need to be closely monitored during the switch and the initial weeks thereafter; - That they should consult their healthcare provider for further information;
- Med prehodom in v prvih tednih po njem morajo bolniki skrbno spremljati glukozo v krvi.
Dose pointer
KORAK).
A Choose a place to inject as shown in the picture labelled “Places to inject” B Push the needle into your skin as shown by your doctor, pharmacist or nurse.
A Izberite mesto za injiciranje, kot prikazuje slika ˝Mesta za injiciranje˝.
• Details on how to minimize the safety concern addressed by the additional risk minimization measures through appropriate monitoring and management: - That insulin glargine 100 units/ml and insulin glargine 300 units/ml (Toujeo SoloStar and Toujeo DoubleStar) are not bioequivalent and are therefore not interchangeable without dose adjustment.
- Insulin glargin 100 enot/ml in insulin glargin 300 enot/ml (zdravilo Toujeo SoloStar in Toujeo DoubleStar) nista bioekvivalentna in zato nista medsebojno zamenljiva brez prilagoditve odmerka.
Each pen contains 3 ml of solution, equivalent to 900 units.
En injekcijski peresnik vsebuje 3 ml raztopine; to ustreza 900 enotam.
Meal-time insulin analogue
Zdravljenje v kombinaciji z insulinskim analogom ob obrokih
If this happens: - change the needle (see STEP 6 and STEP 2), - then repeat the safety test (STEP 3A and STEP 3 B).
Če se to zgodi: - zamenjajte iglo (glejte 6.
Date of first authorisation: 21 June 2016
Datum prve odobritve: 21. junij 2016
These are medicinal products within class where similar interactions could be predicted.
To so zdravila znotraj razreda, kjer je mogoče predvideti podobne interakcije.
Your doctor will give you a different medicine.
Vaš zdravnik vam bo dal drugo zdravilo.
Adults: one tablet each day with food
Odrasli: ena tableta na dan s hrano
This should be considered when assessing a patient's ability to drive or operate machinery.
To je treba upoštevati pri ocenjevanju bolnikove sposobnosti za vožnjo ali upravljanje strojev.
Most adverse reactions were Grade 1 or 2.
Največ neželenih učinkov je bilo stopnje 1 ali 2.
Most of this increase in creatinine and decrease in eGFR occurred within the first four weeks of treatment.
Večina povečanj kreatinina in zmanjšanj eGFR se je pojavila v prvih štirih tednih zdravljenja.
These events have often been transitory.
Ti neželeni učinki so pogosto prehodni.
 Tell your doctor if you are taking any of these medicines.
 Povejte svojemu zdravniku, če jemljete katero od teh zdravil.