natgillin/translations-raw huggingface dataset:
Patients should be informed that the dose counter of Toujeo SoloStar or Toujeo DoubleStar pre-filled pen shows the number of units of Toujeo to be injected.
Bolnikom je treba povedati, da odmerno okence na napolnjenih injekcijskih peresnikih Toujeo SoloStar in Toujeo DoubleStar kaže število enot zdravila Toujeo, ki bodo injicirane.
Please, see also section 3.
Prosimo, glejte poglavje 3.
If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.
Če imate dodatna vprašanja o uporabi zdravila, se posvetujte z zdravnikom, farmacevtom ali z medicinsko sestro.
Then eat something (such as bread or pasta) that will raise your blood sugar over a longer time.
Potem zaužijte nekaj, kar krvni sladkor zviša za dalj časa (na primer kruh ali testenine).
This leaflet was last revised in Other source of information
Navodilo je bilo nazadnje revidirano dne
Pioglitazone used together with insulin
Uporaba pioglitazona skupaj z insulinom
• Ensure to use the right insulin.
• Poskrbite, da boste uporabili pravi insulin.
If you have injected too much of this medicine, your blood sugar level may become too low.
Če ste uporabili večji odmerek zdravila Toujeo, kot bi smeli Če ste si injicirali preveč tega zdravila, se vam lahko krvni sladkor preveč zniža.
Be familiar with your warning signs.
Bodite seznanjeni s svojimi opozorilnimi znaki.
• Do not put the pen back in the fridge.
• Peresnika ne dajte nazaj v hladilnik.
SoloStar pen:
SoloStar peresnik:
Toujeo is administered subcutaneously by injection in the abdominal wall, the deltoid or the thigh.
Zdravilo Toujeo je treba injicirati subkutano v trebušno steno, deltoidno mišico ali stegno.
The pen may be stored for a maximum of 6 weeks below 30°C and away from direct heat or direct light.
Napolnjeni injekcijski peresnik lahko shranjujete največ 6 tednov pri temperaturi do 30 °C in zaščiteno pred neposredno vročino in svetlobo.
If you do not see insulin coming out before taking your dose, you could get an underdose or no insulin at all.
Če pred uporabo odmerka ne vidite, da bi iz igle prišel insulin, se lahko zgodi, da injicirate premajhen odmerek ali sploh nič insulina.
• check your pen and the needle are working properly.
• da boste preverili pravilno delovanje peresnika in igle.
- When switching from insulin glargine 100 units/ml to Toujeo, this can be done on a unit-to-unit basis, but a higher Toujeo dose (approximately 10-18%) may be needed to achieve target ranges for plasma glucose levels.
- Prehod z insulina glargin 100 enot/ml na zdravilo Toujeo je mogoče narediti na podlagi enota-zaenoto, toda za doseganje ciljnega območja koncentracije glukoze v plazmi so lahko potrebni (za približno 10 do 18%) večji odmerki zdravila Toujeo.
• The Toujeo DoubleStar pen contains 900 units of Toujeo.
• Peresnik Toujeo DoubleStar vsebuje 900 enot zdravila Toujeo.
To ensure the pen and needle are working, always perform the safety test until you see insulin coming out the needle tip before each injection (see STEP 3).
Za preverjanje, da peresnik in igla delujeta, vedno pred vsakim injiciranjem opravite varnostni preizkus, dokler ne vidite, da je iz konice igle prišel insulin (glejte 3.
Before using Toujeo SoloStar pre-filled pen or Toujeo DoubleStar pre-filled pen, the instructions for use included in the package leaflet must be read carefully (see section 6.6).
Pred uporabo napolnjenega injekcijskega peresnika Toujeo SoloStar ali napolnjenega injekcijskega peresnika Toujeo DoubleStar mora bolnik natančno prebrati navodilo za uporabo, navedena na priloženem navodilu za uporabo (glejte poglavje 6.6).
Table 3 - Summary of the hypoglycaemic episodes of the clinical study in patients with type 1 and type 2 diabetes mellitus
Povzetek hipoglikemij v klinični študiji pri bolnikih s sladkorno boleznijo tipa 1 in tipa 2.
Packs of 1, 3, 6 (2 packs of 3), 9 (3 packs of 3) and 10 pre-filled pens.
Na voljo so pakiranja z 1, 3, 6 (2 pakiranja po 3), 9 (3 pakiranja po 3) in 10 napolnjenimi injekcijskimi peresniki.
What you need to know before you use Toujeo Do not use Toujeo
Kaj morate vedeti, preden boste uporabili zdravilo Toujeo
A Select 3 units by turning the dose selector until the dose pointer is at the mark between 2 and
A Nastavite 3 enote tako, da zavrtite izbirnik odmerka, dokler kazalnik odmerka ne kaže oznake med 2 in 4.
The Toujeo SoloStar and Toujeo DoubleStar pre-filled pens have been specifically designed for Toujeo and no dose re-calculation is required for either pen.
Napolnjeni injekcijski peresnik Toujeo SoloStar in Toujeo DoubleStar sta posebej izdelana za zdravilo Toujeo, zato odmerka ni treba preračunavati.
Tell a doctor straight away if you notice signs of a severe allergic reaction.
Če opazite znake hude alergijske reakcije, morate o tem nemudoma obvestiti zdravnika.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON Multipack (contains Blue Box)
PODATKI NA ZUNANJI OVOJNINI ZUNANJA ŠKATLA skupnega pakiranja (vključuje podatke za modro okence)
• Change the place within the area you inject each day.
• V predelu, kamor injicirate zdravilo, mesto injiciranja vsak dan menjajte.
Toujeo must not be administered intravenously.
Zdravila Toujeo se ne sme dajati intravensko.
Plasma glucose reductions at the end of the trial with Toujeo were similar to insulin glargine 100 units/ml with a more gradual reduction during the titration period with Toujeo.
Znižanja glukoze v plazmi so bila na koncu preskušanja z zdravilom Toujeo podobna kot z insulinom glargin 100 enot/ml, a s postopnejšim zniževanjem med obdobjem titriranja zdravila Toujeo.
• Diuretics - for high blood pressure or fluid retention.
• Diuretike - za visok krvni tlak ali zastajanje tekočine v telesu.
Mild episodes of hypoglycaemia can usually be treated with oral carbohydrates.
Blage hipoglikemije je po navadi mogoče obvladati z uživanjem ogljikovih hidratov.
What Toujeo looks like and contents of the pack
Izgled zdravila Toujeo in vsebina pakiranja
Adjusted mean differenceb
Korigirana povprečna razlikab
Results support the use of Toujeo in paediatric patients with type 2 diabetes mellitus.
Rezultati podpirajo uporabo zdravila Toujeo pri otrocih s sladkorno boleznijo tipa 2.
Adjusted Mean change from baseline Adjusted Mean differenceb
Korigirana povprečna sprememba od izhodišča Korigirana povprečna razlikab
To prevent possible transmission of disease, insulin pens should never be used for more than one person, even when the needle is changed (see section 6.6).
Da bi preprečili možen prenos bolezni, se insulinski peresniki nikoli ne smejo uporabljati pri več kot eni osebi, tudi če se zamenja injekcijska igla (glejte poglavje 6.6).
In Toujeo clinical studies in adult patients, the incidence of allergic reactions was similar in Toujeo-treated patients (5.3%) and insulin glargine 100 units/ml-treated patients (4.5%).
V kliničnih študijah pri odraslih bolnikih je bila incidenca alergijskih reakcij podobna pri bolnikih, zdravljenih z zdravilom Toujeo (5,3 %), in bolnikih, zdravljenih z insulinom glargin 100 enot/ml (4,5 %).
If you re-use a needle this increases the risk of it becoming blocked and of you getting too much or too little insulin.
Igel nikdar ne uporabljajte ponovno - če iglo ponovno uporabite, to poveča tveganje, da se bo zamašila in da boste dobili preveč ali premalo insulina.
• Do not inject a double dose to make up for a forgotten dose.
• Ne vzemite dvojnega odmerka, če ste pozabili injicirati prejšnji odmerek.
Figure 1 shows results from a cross-over study in 18 patients with type 1 diabetes conducted for a maximum of 36 hours after injection.The effect of Toujeo was beyond 24 hours (up to 36 hours) at clinically relevant doses.
Slika 1 prikazuje rezultate navzkrižne študije pri 18 bolnikih s sladkorno boleznijo tipa 1, ki je potekala do največ 36 ur po injiciranju.
As with all insulins, the time course of action of insulin glargine may be affected by physical activity and other variables.
Na časovni potek delovanja insulina glargin lahko vplivajo telesna dejavnost in drugi spremenljivi dejavniki, tako kot velja za vsa insulinska zdravila.
How to care for your pen Handle your pen with care
Kako skrbeti za peresnik
Your blood sugar level may fall (hypoglycaemia) if you take:
Krvni sladkor vam lahko pade (hipoglikemija), če jemljete:
Talk to your doctor before travelling.
Pred potovanjem se posvetujte z zdravnikom - morda se boste morali posvetovati:
• Do not dial your dose by counting the clicks.
• Ne nastavljajte odmerka s štetjem klikov, ki jih slišite.
Insulin glargine 100 units/ml and Toujeo are not bioequivalent and are not directly interchangeable.
Insulin glargin 100 enot/ml in zdravilo Toujeo nista bioekvivalentna in nista medsebojno zamenljiva.
The half-life after subcutaneous administration of Toujeo is determined by the rate of absorption from the subcutaneous tissue.
Razpolovni čas po subkutani uporabi zdravila Toujeo določa hitrost absorpcije iz podkožnega tkiva.
To prevent possible transmission of disease, insulin pen should never be used by for more than one person, even when the needle is changed (see section 4.2).
Da bi preprečili možen prenos bolezni, se insulinski peresniki nikoli ne smejo uporabljati pri več kot eni osebi, tudi če se zamenja injekcijsko iglo (glejte poglavje 4.2).
Re-use of needles increases the risk of blocked needles which may cause underdosing or overdosing.
Ponovna uporaba igel povečuje tveganje, da bo igla zamašena, to pa lahko povzroči preveliko ali premajhno odmerjanje.
Patients previously treated with basal insulin
Bolniki, predhodno zdravljeni z bazalnim insulinom
Use only in this pen or severe overdose can result.
Uporabite samo v tem injekcijskem peresniku, sicer lahko pride do hudega prevelikega odmerjanja.
• If you turn past your dose, you can turn back down.
• Če zavrtite več, kot je vaš odmerek, lahko izbirnik odmerka zavrtite nazaj.
Toujeo is for subcutaneous use only.
Zdravilo Toujeo je namenjeno samo za subkutano uporabo.
If you are breast-feeding, talk to your doctor, as your insulin doses and your diet might need to be changed.
Če dojite, se posvetujte z zdravnikom, kajti morda bo treba prilagoditi odmerek insulina in prehrano.
5 pens
5 sekund
When switching from a treatment regimen with an intermediate or long-acting insulin product to a regimen with Toujeo, a change of the dose of the basal insulin may be required and the concomitant anti-hyperglycaemic treatment may need to be adjusted.
Pri prehodu s srednjedolgo- ali dolgodelujočega insulina na zdravljenje z zdravilom Toujeo sta lahko potrebni sprememba odmerka bazalnega insulina in prilagoditev sočasnih antihiperglikemičnih zdravil.
No significant difference was seen in the progression of diabetic retinopathy when insulin glargine100 units/ml was compared to NPH insulin.
Primerjava napredovanja diabetične retinopatije ni pokazala značilne razlike med insulinom glargin 100 enot/ml in insulinom NPH.
Serious low blood sugar may cause brain damage and may be life-threatening.
Resno znižanje krvnega sladkorja lahko povzroči okvaro možganov in je lahko smrtno nevarno.
Insulin glargine is a human insulin analogue designed to have a low solubility at neutral pH. At pH 4, insulin glargine is completely soluble.
Insulin glargin je analog humanega insulina, pripravljen tako, da je pri nevtralnem pH slabo topen.
A Choose a place to inject as shown in the picture B Push the needle into your skin as shown by your doctor, pharmacist or nurse.
B Zabodite iglo v kožo, kot vam je pokazal zdravnik, farmacevt ali medicinska sestra.
Type 1 diabetes mellitus
Bolniki s sladkorno boleznijo tipa 1
If no insulin appears:
C Ponovite ta korak, če se insulin ne pojavi:
Tel: 800 13 12 12 (domande di tipo tecnico) +39 800 536389 (altre domande e chiamate dall'estero)
Tel: 800 13 12 12 (domande di tipo tecnico)
- then repeat the safety test (STEP 3).
KORAK) - potem ponovite varnostni preizkus (3.
• Set the dose by turning the dose selector to a line in the dose window.
• Nastavite odmerek tako, da izbirnik odmerka vrtite glede na črtico v okencu, ki kaže odmerek.
30 units selected
izbrani odmerek 30 enot
General disorders and administration site conditions Injection site reactions include redness, pain, itching, hives, swelling, or inflammation.
Med reakcijami na mestu injiciranja so pordelost, bolečine, srbenje, urtikarija, otekanje ali vnetje.
In Toujeo clinical studies in adult patients, the incidence of injection site reactions was similar in Toujeo-treated patients (2.5%) and insulin glargine 100 units/ml-treated patients (2.8%).
V kliničnih študijah pri odraslih bolnikih je bila incidenca reakcij na mestu injiciranja podobna pri bolnikih, zdravljenih z zdravilom Toujeo (2,5 %), in bolnikih, zdravljenih z insulinom glargin 100 enot/ml (2,8 %).
Each ml contains 300 units (10.91 mg) insulin glargine.
En mililiter vsebuje 300 enot (10,91 mg) insulina glargin.
- The dose selector of your Toujeo DoubleStar pen dials in steps of 2 units.
- Izbirnik odmerka vašega Toujeo DoubleStar peresnika omogoča odmerjanje v korakih po 2 enoti.
Particular caution should be exercised, and intensified blood glucose monitoring is advisable in patients in whom hypoglycaemic episodes might be of particular clinical relevance, such as in patients with significant stenosis of the coronary arteries or of the blood vessels supplying the brain (risk of cardiac or cerebral complications of hypoglycaemia) as well as in patients with proliferative retinopathy, particularly if not treated with photocoagulation (risk of transient amaurosis following hypoglycaemia).
Med takšnimi bolniki so bolniki s pomembno stenozo koronarnih arterij ali možganskih žil (nevarnost srčnih ali možganskih zapletov zaradi hipoglikemije), pa tudi bolniki s proliferativno retinopatijo, zlasti če ni zdravljena s fotokoagulacijo (nevarnost prehodne slepote po hipoglikemiji).
58 units selected
izbrani odmerek 60 enot izbrani odmerek 58 enot
RR: 0.82 [0.33;2.00]
RT: 0,82 [0,33;2,00]
• If safety tests are not performed before the first use of a new pen, insulin underdose can occur.
• Če bolnik pred prvo uporabo novega peresnika ne opravi varnostnega preizkusa, lahko to povzroči premajhno odmerjanje zdravila.
Never put the inner needle cap back on.
Nikdar znova ne namestite notranjega pokrovčka igle.
Never use a syringe to remove Toujeo from your SoloStar pen or severe overdose can result.
Nikoli ne uporabite igle, da bi odstranili zdravilo Toujeo iz vašega injekcijskega peresnika SoloStar, sicer lahko pride do hudega prekomernega odmerjanja.
Insulin administration may cause insulin antibodies to form.
Uporaba insulina lahko povzroči nastanek protiteles proti njemu.
• You may need to repeat this step up to 3 times before seeing insulin.
• Če uporabljate nov peresnik prvič, boste morda morali ta korak ponoviti do 6-krat, preden se bo pojavil insulin.
Before first use, the pen must be stored at room temperature at least 1 hour before use.
6.6 Posebni varnostni ukrepi za odstranjevanje in ravnanje z zdravilom Pred prvo uporabo mora biti injekcijski peresnik vsaj 1 uro shranjen na sobni temperaturi.
Packs of 1, 3, 5 and 10 pre-filled pens.
Na voljo so pakiranja z 1, 3, 5 in 10 napolnjenimi injekcijskimi peresniki.
Overall, these effects on hypoglycaemia risk were consistently observed whatever the age, gender, BMI and duration of diabetes (<10 years and ≥10 years) in Toujeo-treated patients compared to insulin glargine 100 units/ml-treated patients.
V celoti so te učinke na tveganje za hipoglikemije pri bolnikih, zdravljenih z zdravilom Toujeo, v primerjavi z bolniki, zdravljenimi z insulinom glargin 100 enot/ml, opažali dosledno, ne glede na starost, spol, ITM in trajanje sladkorne bolezni (< 10 let v primerjavi z ≥ 10 let).
Cartridge (type 1 colourless glass) with a black plunger (bromobutyl rubber) and a flanged cap (aluminium) with a stopper (laminate of isoprene and bromobutyl rubber).The cartridge is sealed in a disposable pen injector.
Vložek (iz brezbarvnega stekla tipa 1) s črnim batom (iz brombutilne gume) in prirobljena zaporka (iz aluminija), z zamaškom (iz brombutilne gume ali laminata poliizoprena).
You must always check the insulin label before each injection to avoid mix-ups between Toujeo and other insulins.
Pred vsakim injiciranjem preverite nalepko insulina, da se boste izognili naključnim zamenjavam zdravila Toujeo in drugih insulinov.
When needed, Toujeo can be injected up to 3 hours before or after the time you usually inject it.
Če ste pozabili uporabiti zdravilo Toujeo Če je treba, lahko zdravilo Toujeo injicirate do 3 ure pred ali po času, ko ga injicirate po navadi.
Incidence (%) of confirmedb hypoglycaemia (n/Total N)
Incidenca (%) potrjenihb hipoglikemij (n/celotni N) Celotno obdobje študije
- That insulin glargine 300 units/ml is available in two different presentations: Toujeo SoloStar (1.5 mL prefilled pen/450 units) and Toujeo DoubleStar (3 mL prefilled pen/900 units).
Insulin glargin 300 enot/ml je na voljo v dveh različnih oblikah: Toujeo SoloStar (1,5-ml napolnjen injekcijski peresnik/450 enot) in Toujeo DoubleStar (3-ml napolnjen injekcijski peresnik/900 enot).
It is essential for patients with pre-existing or gestational diabetes to maintain good metabolic control throughout pregnancy to prevent adverse outcomes associated with hyperglycaemia.
Za preprečitev neželenih učinkov povezanih s hiperglikemijo, je nujno, da bolnice z obstoječo ali gestacijsko sladkorno boleznijo vso nosečnost vzdržujejo dobro urejenost presnove.
The medicinal product may be stored for a maximum of 6 weeks below 30°C and away from direct heat or direct light.
Rok uporabnosti po prvi uporabi injekcijskega peresnika Zdravilo se sme shranjevati največ 6 tednov pri temperaturi do 30°C in zaščiteno pred neposredno toploto ali svetlobo.
Lipodystrophy and cutaneous amyloidosis may occur at the injection site and delay local insulin absorption.
Na mestu injiciranja se lahko pojavita lipodistrofija in kožna amiloidoza, ki upočasnita lokalno absorpcijo insulina.
The strength is highlighted in honey gold on the label of your Toujeo DoubleStar pre-filled pen.
Jakost »300« je poudarjena v medeno zlati barvi na ovojnini vašega Toujeo DoubleStar napolnjenega peresnika.
Throw away the used needle in a puncture resistant container, or as told by your pharmacist or local authority.
Uporabljeno iglo zavržite v posodo za odlaganje ostrih odpadkov ali kot vam je svetoval farmacevt ali lokalna agencija.
Never use a syringe to remove Toujeo from your DoubleStar pen or severe overdose can result.
Nikoli ne uporabite igle, da bi odstranili zdravilo Toujeo iz vašega injekcijskega peresnika DoubleStar, sicer lahko pride do hudega prekomernega odmerjanja.
you may get too much or too little insulin.
To lahko povzroči premajhno ali preveliko odmerjanje insulina.
- Do not use your pen if there is still no insulin coming out of the needle tip.
- Ne uporabite peresnika, če iz konice igle še vedno ne priteče insulin.
Read the package leaflet before use.
Vložek pred uporabo preglejte.
• You may see air bubbles in the insulin.
Če opazite zračne mehurčke • V insulinu lahko opazite zračne mehurčke.
RR*: 0.69 [0.39;1.23]
RT*: 0,69 [0,39;1,23]
If you experience signs of heart failure such as unusual shortness of breath, a rapid increase in weight or localised swelling (oedema).
Zdravnika morate čim prej obvestiti, če se vam pojavijo znaki srčnega popuščanja, npr. nenavadno kratka sapa, hitro povečanje telesne mase ali omejeno otekanje (edemi).
Toujeo IGlar Toujeo IGlar Toujeo IGlar
Toujeo IGlar
Cartridge (type 1 colourless glass) with a grey plunger (bromobutyl rubber) and a flanged cap (aluminium) with a stopper (laminate of isoprene and bromobutyl rubber).The cartridge is sealed in a disposable pen injector.
Vložek (iz brezbarvnega stekla tipa 1) s sivim batom (iz brombutilne gume) in prirobljena zaporka (iz aluminija), z zamaškom (iz brombutilne gume ali laminata poliizoprena).
Always do a safety test before each injection - this is to:
Pred injiciranjem vedno opravite varnostni preizkus:
Each line in the dose window is an even number:
Vsaka črtica v okencu kazalnika odmerka prikazuje sodo število.
Rubber seal
Gumijasta zaporka
A syringe must never be used to withdraw Toujeo from the cartridge of the pre-filled pen or severe overdose can result (see section 4.2, 4.4 and 4.9).
Zdravila Toujeo se iz vložka napolnjenega injekcijskega peresnika ne sme izvleči v injekcijsko brizgo, sicer lahko pride do hudega prevelikega odmerjanja (glejte poglavja 4.2, 4.4 in 4.9).
[-0.144 to 0.083]
-0,03 [-0,144 do 0,083]
The percentage of patients reporting severe hypoglycaemia was lower in patients in the Toujeo group as compared to patients in the insulin glargine 100 units/mL group, 6% and 8.8% respectively.
Odstotek bolnikov, ki so poročali o hudi hipoglikemiji, je bil v skupini z zdravilom Toujeo manjši (6 %) kot v skupini z insulinom glarginom 100 enot/ml (8,8 %).
These cases did not contain confounders and have a compatible time to onset.
V teh primerih motečih dejavnikov ni bilo, čas do pojava neželenega učinka pa je bil združljiv z uporabo zdravila.
If your blood sugar is too low, follow the guidance for hypoglycaemia (see information in the box at the end of this leaflet).
• Prenizek krvni sladkor (hipoglikemija) - Če imate prenizek krvni sladkor, upoštevajte navodila za ravnanje v primeru hipoglikemije (glejte informacije v okviru na koncu tega navodila).
Medication errors have been reported in which other insulins, particularly rapid-acting insulins, have been accidentally administered instead of long-acting insulins.
Poročali so o napakah, pri katerih so bili namesto dolgodelujočih insulinov pomotoma uporabljeni hitrodelujoči.
DoubleStar pen:
DoubleStar peresnik:
Toujeo lowers your blood sugar steadily over a long period of time.
Zdravilo Toujeo zniža krvni sladkor enakomerno skozi daljši čas.
C Repeat this step if no insulin appears: • If you are using a new pen for the first time, you may have to repeat this step up to 6 times before seeing insulin.
Če se insulin ne pojavi: • Ta korak boste morda morali ponoviti do 3-krat, preden se bo pojavil insulin.
Patients with type 1 diabetes mellitus Toujeo is to be used once-daily with meal-time insulin and requires individual dose adjustments.
Zdravilo Toujeo je treba uporabljati enkrat na dan z insulinom ob obrokih in zahteva individualno prilagajanje odmerka.
Always perform a safety test before you use a new pen for the first time until you see insulin coming out of the needle tip (see STEP 3).
Pred prvo uporabo novega peresnika vedno opravite varnostni preizkus, dokler ne vidite, da je iz konice igle prišel insulin (glejte 3.
Similarly, nocturnal hypoglycaemia was comparable in the Toujeo and insulin glargine 100 units/mL treatment groups.
Podobno so bile tudi nočne hipoglikemije v terapevtski skupini z zdravilom Toujeo primerljive kot v skupini z insulinom glarginom 100 enot/ml.
• Do not stop your insulin
• Ne prenehajte uporabljati insulina.
Incidence (%) of severea hypoglycaemia (n/Total N)
Incidenca (%) hudiha hipoglikemij (n/celotni N) Celotno obdobje študijed
The following adverse reactions were observed during clinical studies conducted with Toujeo (see section 5.1) and during clinical experience with insulin glargine 100 units/ml.
Med kliničnimi študijami, izvedenimi z zdravilom Toujeo (glejte poglavje 5.1), in med klinično uporabo insulina glargin 100 enot/ml so opažali naslednje neželene reakcije.
These factors include: - change in the injection area, - improved insulin sensitivity (e.g., by removal of stress factors), - unaccustomed, increased or prolonged physical activity, - intercurrent illness (e.g. vomiting, diarrhoea), - inadequate food intake, - missed meals,
- sprememba predela injiciranja, - izboljšana občutljivost za insulin (npr. zaradi odstranitve stresnih dejavnikov), - nevajena, večja ali dolgotrajnejša telesna dejavnost, - sočasna bolezen (npr. bruhanje, driska), - nezadostno uživanje hrane, - izpuščeni obroki, - pitje alkohola, - določene nekompenzirane endokrine motnje (npr. pri hipotiroidizmu, insuficienci sprednjega režnja hipofize ali insuficienci nadledvične skorje), - sočasno zdravljenje z določenimi drugimi zdravili (glejte poglavje 4.5).