natgillin/translations-raw huggingface dataset:
A crossover study comparing insulin glargine plus lispro insulin to NPH plus regular human insulin (each treatment administered for 16 weeks in random order) in 26 adolescent type 1 diabetic patients aged 12 to 18 years was also performed.
Opravljena je bila tudi navzkrižna študija za primerjavo insulina glargin skupaj z insulinom lispro ter insulina NPH skupaj z navadnim humanim insulinom (vsako zdravljenje je bilo uporabljano 16 tednov v slučajnem zaporedju).
The adverse reaction reports received from post marketing surveillance included relatively more frequent injection site reactions (injection site pain, injection site reaction) and skin reactions (rash, urticaria) in children and adolescents (≤ 18 years of age) than in adults.
Med neželenimi učinki, poročanimi v postmarketinških raziskavah, se pri otrocih in mladostnikih starih (≤ 18 let) v primerjavi z odraslimi bolniki relativno pogosteje pojavljajo reakcije na mestu injiciranja (bolečina na mestu injiciranja, reakcija na mestu injiciranja) in kožne reakcije (srbenje, urtikarija).
In clinical studies, antibodies that cross-react with human insulin and insulin glargine were observed with the same frequency in both NPH-insulin and insulin glargine treatment groups.
Klinična varnost in učinkovitost V kliničnih raziskavah so protitelesa, ki navzkrižno reagirajo s človeškim insulinom in insulinom glargin, enako pogosto ugotavljali med prejemniki insulina NPH in insulina glargin.
- determine how much ABASAGLAR per day you will need and at what time, - tell you when to check your blood sugar level, and whether you need to carry out urine tests, - tell you when you may need to inject a higher or lower dose of ABASAGLAR.
- povedal, kdaj merite krvni sladkor in ali morate opravljati teste urina,
PARTICULARS TO APPEAR ON THE OUTER PACKAGING INTERMEDIATE CARTON of a multipack (without blue box) - KwikPen
VMESNA OVOJNINA (brez modrega okenca) sestavni del večjega pakiranja - peresnik KwikPen
Common ide effects (may affect up to 1 in 10 people)
Pogosto poročani neželeni učinki (pojavijo se lahko pri največ 1od 10 bolnikov)
HbA1c changes from baseline were similar between treatment groups; however blood glucose values recorded overnight were significantly higher in the insulin glargine/ lispro group than the NPH/regular group, with a mean nadir of 5.4 mM vs. 4.1 mM.
Toda vrednosti glukoze v krvi čez noč so bile v skupini z insulinom glargin in insulinom lispro značilno večje kot v skupini z insulinom NPH in navadnim insulinom; povprečna najnižja vrednost je bila v prvi skupini 5,4 mM in v drugi 4,1 mM.
Paper Tab
Papirni pokrovček
In euglycaemic clamp studies in healthy subjects or in patients with type 1 diabetes, the onset of action of subcutaneous insulin glargine was slower than with human NPH insulin, its effect profile was smooth and peakless, and the duration of its effect was prolonged.
V študijah z evglikemično vklenjenostjo pri zdravih preiskovancih ali bolnikih z diabetesom tipa 1 je bil začetek delovanja subkutano apliciranega insulina glargin počasnejši kot humanega insulina NPH,
Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu
Podrobne informacije o tem zdravilu so na voljo na spletni strani Evropske agencije za zdravila, http://www.ema.europa.eu
Detailed information is available on the website of the European Medicines Agency http://www.ema.europa.eu.
Podrobne informacije so na voljo na spletni strani Evropske agencije za zdravila, http://www.ema.europa.eu.
Insulin treatment can cause the body to produce antibodies to insulin (substances that act against insulin).
Zaradi zdravljenja z insulinom lahko telo tvori protitelesa proti insulinu (snovi, ki delujejo proti insulinu), vendar je zelo redko zaradi tega treba spremeniti vaš odmerek insulina.
Over the course of this 6-year study, 42% of the insulin glargine group did not experience any hypoglycaemia.
preiskovancev v skupini z insulinom glargin ni doživelo nobene hipoglikemije.
Empty pens must not be re-filled and must be properly discarded.
Praznih vložkov ne smete znova polniti, pač pa jih je treba ustrezno zavreči.
The cartridges should only be used in conjunction with a Lilly reusable insulin pen and should not be used with any other reusable pen as the dosing accuracy has not been established with other pens.
Ne smete jih uporabljati z nobenim drugim injekcijskim peresnikom za večkratno uporabo, saj natančnost odmerjanja za druge injekcijske peresnike ni bila ugotovljena.
In use:
Ko je v uporabi:
Empty cartridges must not be refilled and must be properly discarded.
Praznih peresnikov ne smete znova napolniti, pač pa jih je treba ustrezno zavreči.
In patients with proliferative retinopathy, particularly if not treated with photocoagulation, severe hypoglycaemic episodes may result in transient amaurosis.
Pri bolnikih s proliferativno retinopatijo lahko hude hipoglikemije povzročijo prehodno slepoto, zlasti če retinopatija ni zdravljena s fotokoagulacijo.
- get a new pen and inject the full dose.
Pritrdite novo iglo in aktivirajte injekcijski peresnik
The pen should be used as recommended in the information provided.
Peresnik morate uporabljati, kot je priporočeno v priloženih navodilih.
ABASAGLAR 100 units/mL solution for injection in a cartridge is a clear and colourless solution.
ABASAGLAR 100 enot/ml, raztopina za injiciranje v vložku, je bistra in brezbarvna raztopina.
• Carefully replace the outer needle shield.
Previdno znova namestite zaščito zunanje igle.
• Pull the pen cap straight off.
• S hitrim potegom odstranite pokrovček s peresnika.
Store in original package in order to protect from light.
Shranjujte v originalni ovojnini za zagotovitev zaščite pred svetlobo.
Look at the cartridge before you use it. Only use it if the solution is clear, colourless and water-like, and has no visible particles in it. Do not shake or mix it before use.
Uporabite jo le, če je raztopina v njej bistra, brezbarvna, podobna vodi in ne vsebuje vidnih delcev.
A 24-week parallel group study was conducted in 125 children with type 1 diabetes mellitus aged 2 to 6 years, comparing insulin glargine given once daily in the morning to NPH insulin given once or twice daily as basal insulin.
Opravljena je bila 24-tedenska študija za primerjavo bazalnih insulinov, tj. insulina glargin, ki so ga uporabljali enkrat na dan (zjutraj), in insulina NPH, ki so ga uporabljali enkrat ali dvakrat na dan.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON - KwikPen.
PODATKI NA ZUNANJI OVOJNINI ZUNANJA OVOJNINA - peresnik KwikPen.
No significant difference was seen in the progression of diabetic retinopathy when insulin glargine was compared to NPH insulin.
Ko so primerjali insulin glargin z insulinom NPH, pri razvoju diabetične retinopatije niso opazili pomembnih razlik.
The first symptoms which alert you to hypoglycaemia ("warning symptoms") may change, be weaker or may be missing altogether if - you are elderly, if you have had diabetes for a long time or if you suffer from a certain type of nervous disease (diabetic autonomic neuropathy), - you have recently suffered hypoglycaemia (for example the day before) or if it develops slowly, - you have almost normal or, at least, greatly improved blood sugar levels, - you have recently changed from an animal insulin to a human insulin such as ABASAGLAR, - you are taking or have taken certain other medicines (see section 2, "Other medicines and
- ste nedavno (na primer prejšnji dan) doživeli hipoglikemijo ali če se hipoglikemija pojavi počasi, - imate skoraj normalno ali vsaj močno izboljšano koncentracijo krvnega sladkorja, - ste namesto živalskega insulina pred kratkim začeli uporabljati humani insulin, kakršen je zdravilo ABASAGLAR,
Look at the cartridge before you use the pen.
Vložek si pred uporabo peresnika oglejte.
ABASAGLAR must not be mixed with any other insulin or diluted.
Zdravila ABASAGLAR se ne sme mešati z nobenim drugim insulinom in se ga ne sme redčiti.
- unaccustomed, increased or prolonged physical activity, - intercurrent illness (e.g. vomiting, diarrhoea), - inadequate food intake, - missed meals, - alcohol consumption, - certain uncompensated endocrine disorders, (e.g. in hypothyroidism and in anterior pituitary or adrenocortical insufficiency), - concomitant treatment with certain other medicinal products.
- določene nekompenzirane endokrine motnje (npr. hipotiroidizem, insuficienca sprednjega režnja hipofize ali insuficienca nadledvične skorje), - sočasno zdravljenje z določenimi drugimi zdravili.
In healthy subjects and diabetic patients, insulin serum concentrations indicated a slower and much more prolonged absorption and showed a lack of a peak after subcutaneous injection of insulin glargine in comparison to human NPH insulin.
Absorpcija Koncentracija insulina v serumu pri zdravih preiskovancih in diabetikih je po subkutani injekciji insulina glargin v primerjavi s humanim insulinom NPH pokazala počasnejšo in mnogo dolgotrajnejšo absorpcijo ter ni imela vrha.
Priming your pen Prime before each injection.
Aktivacija peresnika Aktivirajte peresnik pred vsakim injiciranjem.
These include patients: - in whom glycaemic control is markedly improved, - in whom hypoglycaemia develops gradually, - who are elderly, - after transfer from animal insulin to human insulin, - in whom an autonomic neuropathy is present, - with a long history of diabetes, - suffering from a psychiatric illness, - receiving concurrent treatment with certain other medicinal products (see section 4.5).
- ki so starejši, - po prehodu z živalskega na humani insulin, - ki imajo avtonomno nevropatijo, - z dolgo anamnezo diabetesa,
Step 13:
Korak 13:
Children below 2 years of age The safety and efficacy of insulin glargine have not been established No data are available.
Varnost in učinkovitost insulina glargin nista bili ugotovljeni.
You will NOT receive your insulin by turning the dose knob.
Z obračanjem gumba za odmerjanje NE prejmete insulina.
IGF-1 receptor binding: The affinity of insulin glargine for the human IGF-1 receptor is approximately 5 to 8-fold greater than that of human insulin (but approximately 70 to 80-fold lower than the one of IGF-1), whereas M1 and M2 bind the IGF-1 receptor with slightly lower affinity compared to human insulin.
8-krat večja kot afiniteta humanega insulina (vendar približno 70- do 80-krat manjša kot afiniteta IGF
There is no experience with the use of ABASAGLAR in children below the age of 2 years.
Pri otrocih, mlajših od 2 let, izkušenj z uporabo zdravila ABASAGLAR ni.
ABASAGLAR 100 units/mL injection KwikPen insulin glargine
ABASAGLAR 100 enot/ml injekcija KwikPen insulin glargin subkutana uporaba
Talk to your doctor, pharmacist or nurse before using ABASAGLAR.
Posvetujte se z zdravnikom ali s farmacevtom, preden vzamete katero koli zdravilo.
- you have just begun insulin treatment or changed to another insulin preparation (when changing from your previous basal insulin to ABASAGLAR, hypoglycaemia, if it occurs, may be more likely to occur in the morning than at night), - your blood sugar levels are almost normal or are unstable, - you change the area of skin where you inject insulin (for example from the thigh to the upper arm), - you suffer from severe kidney or liver disease, or some other disease such as hypothyroidism.
verjetnejša zjutraj kot ponoči), - je koncentracija vašega krvnega sladkorja skoraj normalna ali ni stabilna, - zamenjate predel kože, kamor injicirate insulin (na primer s stegna na nadlaket), - imate hudo bolezen ledvic ali jeter ali kakšno drugo bolezen, kot je nezadostno delovanje ščitnice.
ABASAGLAR contains insulin glargine.
Zdravilo ABASAGLAR vsebuje insulin glargin.
• Eye reactions
• Splošne težave
Medicinal product subject to medical prescription
Imetnik dovoljenja za promet z zdravilom
Common Uncommon Rare Very rare
Zelo pogosti Pogosti
Keep the cartridge in the outer carton in order to protect from light.
Vložek shranjujte v zunanji ovojnini za zagotovitev zaščite pred svetlobo.
- diuretics (used to treat high blood pressure or excessive fluid retention), - glucagon (pancreas hormone used to treat severe hypoglycaemia), - isoniazid (used to treat tuberculosis), - oestrogens and progestogens (such as in the contraceptive pill used for birth control), - phenothiazine derivatives (used to treat psychiatric disorders), - somatropin (growth hormone), - sympathomimetic medicines (such as epinephrine [adrenaline], salbutamol, terbutaline used to treat asthma), - thyroid hormones (used to treat thyroid gland disorders), - atypical antipsychotic medicines (such as clozapine, olanzapine), - protease inhibitors (used to treat HIV).
- kortikosteroidi (na primer "kortizon", uporabljajo se za zdravljenje vnetja), - danazol (zdravilo, ki deluje na ovulacijo), - diazoksid (uporablja se za zdravljenje visokega krvnega tlaka), - diuretiki (uporabljajo se za zdravljenje visokega krvnega tlaka ali za prekomerno zadrževanje tekočin), - glukagon (hormon, ki ga izloča trebušna slinavka, uporablja pa se za zdravljenje hude hipoglikemije), - izoniazid (uporablja se za zdravljenje tuberkuloze), - estrogeni in progestogeni (na primer kontracepcijske tablete, uporabljajo se za načrtovanje rojstva),
Step 11:
Korak 11:
Your blood sugar levels may either rise or fall if you drink alcohol.
Če pijete alkohol, se vam lahko krvni sladkor zviša ali zniža.
• Pull off the paper tab from the outer needle shield.
Potegnite papirni pokrovček z zaščite zunanje igle.
Always use a new pen if you notice that your blood sugar control is unexpectedly getting worse.
Če opazite, da se urejenost vašega krvnega sladkorja nepričakovano poslabša, vedno uporabite nov vložek.
Although ABASAGLAR contains the same active substance as Toujeo (insulin glargine 300 units/mL), these medicines are not interchangeable.
Čeprav zdravilo ABASAGLAR vsebuje enako učinkovino kot zdravilo Toujeo (insulin glargin
ABASAGLAR KwikPen (“Pen”) is a disposable pen containing 300 units (3 mL) of insulin glargine.
Peresnik ABASAGLAR KwikPen (“peresnik”) je peresnik za enkratno uporabo, ki vsebuje 300 enot
General information about the safe and effective use of your pen • Keep your pen and needles out of the sight and reach of children.
Splošne informacije o varni in učinkoviti uporabi vašega peresnika
• Replace the pen cap by lining up the cap clip with the dose indicator and pushing straight on.
Znova namestite pokrovček peresnika, tako da poravnate sponko pokrovčka s kazalnikom odmerkov in pokrovček potisnete naravnost na peresnik.
Lipoatrophy
Retinopatija
You must always check the insulin label before each injection to avoid mix-ups between ABASAGLAR and other insulins.
Da bi se izognili zamenjavi med zdravilom ABASAGLAR in drugimi insulini, vedno pred vsakim injiciranjem preverite nalepko insulina.
How to store ABASAGLAR
Shranjevanje zdravila ABASAGLAR
The cartridge is sealed in a disposable pen injector.
Vložek je zaprt v injektorju v obliki peresnika za večkratno uporabo.
Visual impairment
Ohišje peresnika
Posology
Vložek
When given intravenously the elimination half-life of insulin glargine and human insulin were comparable.
Izločanje Razpolovni čas izločanja insulina glargin po intravenski uporabi je primerljiv tistemu pri humanem insulinu.
Plasma trough levels of insulin glargine and its main M1 and M2 metabolites were measured in children treated with insulin glargine, revealing plasma concentration patterns similar to adults, and providing no evidence for accumulation of insulin glargine or its metabolites with chronic dosing.
»Najnižje« plazemske ravni insulina glargin in njegovih glavnih metabolitov, M1 in M2, so bile izmerjene pri otrocih, zdravljenih z insulinom glargin
Always use a new cartridge if you notice that your blood sugar control is unexpectedly getting worse.
Če opazite, da se urejenost vašega krvnega sladkorja nepričakovano poslabša, vedno uporabite nov peresnik.
The longer duration of action of subcutaneous insulin glargine is directly related to its slower rate of absorption and supports once daily administration.
Dolgotrajnejše delovanje subkutanega insulina glargin je neposredno povezano z njegovo počasnejšo absorpcijo in podpira uporabo enkrat na dan. Časovni potek delovanja insulina in insulinskih analogov, kakršen je insulin glargin, se lahko zelo razlikuje tako med posamezniki kot pri eni in isti osebi.
Do not use ABASAGLAR if you notice particles in it. Only use ABASAGLAR if the solution is clear, colourless and water like.
Zdravilo ABASAGLAR uporabite le, če je raztopina bistra, brezbarvna in podobna vodi.
- all other medicines to treat diabetes, - angiotensin converting enzyme (ACE) inhibitors (used to treat certain heart conditions or high blood pressure), - disopyramide (used to treat certain heart conditions), - fluoxetine (used to treat depression), - fibrates (used to lower high levels of blood lipids), - monoamine oxidase (MAO) inhibitors (used to treat depression), - pentoxifylline, propoxyphene, salicylates (such as aspirin, used to relieve pain and lower fever), - somatostatin analogues (such as octreotide, used to treat an uncommon condition in which you make too much growth hormone), - sulphonamide antibiotics.
- fluoksetin (uporablja se za zdravljenje depresije), - fibrati (uporabljajo se za zniževanje visokih koncentracij krvnih lipidov), - zaviralci monoaminooksidaze (MAO) (uporabljajo se za zdravljenje depresije), - pentoksifilin, propoksifen, salicilati (na primer acetilsalicilna kislina, uporabljajo se za lajšanje bolečine in znižanje zvišane telesne temperature),
- correct storage of your insulin while travelling, - timing of meals and insulin administration while travelling, - the possible effects of changing to different time zones, - possible new health risks in the countries to be visited, - what you should do in emergency situations when you feel unwell or become ill.
- časovni razpored obrokov in dajanje insulina med potovanjem, - možni vplivi spremembe časovnih pasov,
ABASAGLAR 100 units/mL injection insulin glargine
ABASAGLAR 100 enot /ml injekcija insulin glargin subkutana uporaba
These 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, - alcohol consumption, - certain uncompensated endocrine disorders, (e.g. in hypothyroidism and in anterior pituitary or adrenocortical insufficiency), - concomitant treatment with certain other medicinal products.
- boljša občutljivost za insulin (npr. zaradi odprave dejavnikov stresa), - nevajena, večja ali dolgotrajnejša telesna dejavnost, - sočasna bolezen (npr. bruhanje, driska),
The ABASAGLAR cartridges are to be used only in Lilly insulin pens to ensure you get the correct dose.
Da boste zagotovo prejeli pravilen odmerek, vložke ABASAGLAR uporabljajte le v insulinskih peresnikih Lilly.
KwikPen Parts
Deli peresnika KwikPen
carbohydrates), - you lose carbohydrates due to vomiting or diarrhoea, - you drink alcohol, particularly if you are not eating much, - you are doing more exercise than usual or a different type of physical activity, - you are recovering from an injury or operation or other stress, - you are recovering from an illness or from fever, - you are taking or have stopped taking certain other medicines (see section 2, "Other medicines and ABASAGLAR").
- okrevate po bolezni ali po vročini, - uporabljate ali ste prenehali uporabljati določena druga zdravila (glejte poglavje 2, "Druga zdravila in zdravilo ABASAGLAR").
Insulin label must always be checked before each injection to avoid medication errors between ABASAGLAR and other insulins.
Da bi se izognili napakam zdravljenja zaradi zamenjave med zdravilom ABASAGLAR in drugimi insulini, je potrebno nalepko insulina vedno preveriti pred vsakim injiciranjem.
Speak to a doctor immediately if you are not able to control the hypoglycaemia or if it recurs.
Če hipoglikemije ne morete obvladati ali se ponavlja, se takoj pogovorite z zdravnikom.
EU/1/14/944/008 5 pens EU/1/14/944/013 5 pens
EU/1/14/944/003 5 vložkov EU/1/14/944/009 10 vložkov
- corticosteroids (such as "cortisone" used to treat inflammation), - danazol (medicine acting on ovulation), - diazoxide (used to treat high blood pressure),
- kortikosteroidi (na primer "kortizon", uporabljajo se za zdravljenje vnetja), - danazol (zdravilo, ki deluje na ovulacijo), - diazoksid (uporablja se za zdravljenje visokega krvnega tlaka), - diuretiki (uporabljajo se za zdravljenje visokega krvnega tlaka ali za prekomerno zadrževanje tekočin), - glukagon (hormon, ki ga izloča trebušna slinavka, uporablja pa se za zdravljenje hude hipoglikemije), - izoniazid (uporablja se za zdravljenje tuberkuloze),
Unopened cartridges
Neuporabljeni peresniki
Retinopathy
ZDRAVILA
Examples include: - you have not injected your insulin or not injected enough, or if it has become less effective, for example through incorrect storage, - your insulin pen does not work properly, - you are doing less exercise than usual, you are under stress (emotional distress, excitement), or you have an injury, operation, infection or fever, - you are taking or have taken certain other medicines (see section 2, "Other medicines and
- insulina niste injicirali, ga niste injicirali dovolj ali je postal manj učinkovit, na primer zaradi nepravilnega shranjevanja, - vaš insulinski peresnik ne deluje pravilno,
- A drop of insulin at the needle tip is normal.
- Kapljica insulina na konici igle je običajen pojav in ne vpliva na vaš odmerek.
See the box at the end of this leaflet for further information.
Dodatne informacije najdete v okviru na koncu tega navodila za uporabo.
5sec
V
Pen Cap
Sponka pokrovčka
Substances that may reduce the blood-glucose-lowering effect include corticosteroids, danazol, diazoxide, diuretics, glucagon, isoniazid, oestrogens, progestogens, phenothiazine derivatives, somatropin, sympathomimetic medicinal products (e.g. epinephrine [adrenaline], salbutamol, terbutaline), thyroid hormones, atypical antipsychotic medicinal products (e.g. clozapine and olanzapine) and protease inhibitors.
diazoksid, diuretiki, glukagon, izoniazid, estrogeni, progestogeni, fenotiazinski derivati, somatropin,
You should contact your doctor for advice on driving if: - you have frequent episodes of hypoglycaemia, - the first warning symptoms which help you to recognise hypoglycaemia are reduced or absent.
- imate pogoste hipoglikemije, - so prvi opozorilni znaki hipoglikemije šibki ali jih sploh nimate.
ABASAGLAR 100 units/mL solution for injection in a pre-filled pen
ABASAGLAR 100 enot/ml raztopina za injiciranje v napolnjenem injekcijskem peresniku
ABASAGLAR 100 units/mL solution for injection in a cartridge insulin glargine
ABASAGLAR 100 enot/ml raztopina za injiciranje v vložku insulin glargin
ABASAGLAR 100 units/mL solution for injection in a cartridge and pre-filled pen
ABASAGLAR 100 enot/ml raztopina za injiciranje v vložku in napolnjenem injekcijskem peresniku
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS CARTRIDGE LABEL
PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH
ABASAGLAR 100 units/mL solution for injection in a cartridge
ABASAGLAR 100 enot/ml raztopina za injiciranje v vložku
In-use pens
Pokrovček peresnika
Zinc oxide
Kazalnik odmerkov
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS LABEL TEXT -KwikPen
OVOJNINAH BESEDILO NA NALEPKI -KwikPen
These include: - change in the injection area, - improved insulin sensitivity (e.g., by removal of stress factors),
Ti so: - sprememba predela injiciranja,
Instructions for use KwikPen ABASAGLAR 100 units/mL solution for injection in a pre-filled pen Insulin glargine
Navodilo za uporabo ABASAGLAR 100 enot/ml raztopina za injiciranje v napolnjenem injekcijskem peresniku insulin glargin
ABASAGLAR 100 units/mL solution for injection in a pre-filled pen insulin glargine
ABASAGLAR 100 enot/ml raztopina za injiciranje v napolnjenem injekcijskem peresniku insulin glargin
- beta-blockers (used to treat high blood pressure), - clonidine (used to treat high blood pressure), - lithium salts (used to treat psychiatric disorders).
- klonidin (uporablja se za zdravljenje visokega krvnega tlaka),