FrancophonIA/ELRC3.0 huggingface dataset:
English: These instructions may differ from general pump manual instructions.
Slovenian: Ta navodila se lahko razlikujejo od splošnih navodil v priročniku za črpalko.
English: Animal reproduction studies have not revealed any differences between insulin glulisine and human insulin regarding pregnancy, embryonal/foetal development, parturition or postnatal development (see section 5.3).
Slovenian: Študije reprodukcije pri živalih niso pokazale razlik med insulinom glulisin in humanim insulinom, kar zadeva nosečnost, embrionalni in fetalni razvoj, porod in poporodni razvoj (glejte poglavje 5.3).
English: Most of the cases were related to handling errors or pump system failure.
Slovenian: Večina teh primerov je bila povezana z napakami pri ravnanju ali z odpovedjo sistema s črpalko.
English: Transferring a patient to another type or brand of insulin should be done under strict medical supervision.
Slovenian: Prehod na drugo vrsto ali znamko insulina je treba opraviti pod strogim zdravniškim nadzorom.
English: This means you may not always get enough insulin to treat your diabetes.
Slovenian: To lahko pomeni, da ne dobite dovolj insulina za zdravljenje sladkorne bolezni.
English: Pharmacotherapeutic group: Drugs used in diabetes, insulins and analogues for injection, fast-acting.
Slovenian: Farmakoterapevtska skupina: Zdravila za zdravljenje diabetesa, insulini in analogi za injiciranje s hitrim delovanjem.
English: Figure 1: Average glucose-lowering effect over 6 hours in 20 patients with type 1 diabetes mellitus.
Slovenian: Slika 1: Povprečni učinek na znižanje glukoze v 6 urah pri 20 bolnikih z diabetesom mellitusom tipa 1.
English: Absorption from deltoid sites was in-between (see section 4.2).
Slovenian: Absorpcija z mest v deltoidnem predelu je bila vmes (glejte poglavje 4.2).
English: Injection should be given immediately after mixing as no data are available regarding the mixtures made up a significant time before injection.
Slovenian: Injekcijo je treba dati takoj po mešanju, kajti podatkov o mešanicah, pripravljenih precej pred injiciranjem, ni.
English: This should be kept in mind if treatment with the combination of pioglitazone and Apidra is considered.
Slovenian: To je potrebno upoštevati pri zdravljenju s kombinacijo pioglitazona in zdravila Apidra.
English: Concomitant oral antidiabetic treatment may need to be adjusted.
Slovenian: Potrebna utegne biti prilagoditev sočasnega peroralnega antidiabetičnega zdravljenja.
English: - If you are allergic to insulin glulisine or any of the other ingredients of this medicine (listed in section 6).
Slovenian: • Če ste alergični na insulin glulisin ali katero koli sestavino tega zdravila (navedeno v poglavju
English: - Do not take a double dose to make up for a forgotten dose.
Slovenian: Ne vzemite dvojnega odmerka, če ste pozabili vzeti prejšnji odmerek.
English: The Apidra SoloStar is blue.
Slovenian: Apidra SoloStar je modre barve.
English: Treatment of adults, adolescents and children 6 years or older, with diabetes mellitus, where treatment with insulin is required.
Slovenian: Zdravljenje odraslih, mladostnikov in otrok, starih 6 let ali več, ki imajo diabetes mellitus in potrebujejo zdravljenje z insulinom.
English: Apidra is an antidiabetic agent, used to reduce high blood sugar in patients with diabetes mellitus; it may be given to adults, adolescents and children, 6 years of age and older.
Slovenian: Apidra se uporablja za znižanje visokega krvnega sladkorja pri bolnikih s sladkorno boleznijo; uporabljajo jo lahko odrasli, mladostniki in otroci stari 6 let ali več.
English: There is insufficient clinical information on the use of Apidra in children younger than the age of 6 years.
Slovenian: Ni zadostnih kliničnih podatkov o uporabi zdravila Apidra pri otrocih mlajših od 6 let.
English: Always have available an alternative insulin delivery system for injection under the skin (see section 3 under “How to handle an infusion pump system” and “What to do if the pump system fails or when the pump is used incorrectly”).
Slovenian: Vedno imejte na voljo še drug sistem za dajanje insulina (za injiciranje pod kožo - glejte poglavje 3 "Kako ravnati z infuzijskim sistemom s črpalko" in "Kaj storiti, če sistem s črpalko odpove, ali če črpalka ni pravilno uporabljena").
English: • If your injection is given by another person, or if you are giving an injection to another person, special caution must be taken by this person when removing and disposing of the needle.
Slovenian: • Če vam injekcijo daje druga oseba, ali če vi dajete injekcijo drugi osebi, je potrebna posebna previdnost pri odstranjevanju in odlaganju igle.
English: Your doctor has decided that SoloStar is appropriate for you based on your ability to handle SoloStar.
Slovenian: Vaš zdravnik je presodil, da je SoloStar primeren za vas.
English: • Before each use, a new needle must always be carefully attached and a safety test must be performed.
Slovenian: • Pred vsako uporabo morate natančno namestiti novo iglo in opraviti varnostni preizkus.
English: Insulin requirements may be altered during illness or emotional disturbances.
Slovenian: Potreba po insulinu se lahko spremeni med boleznijo ali čustvenimi obremenitvami.
English: Immediately after delivery, insulin requirements decline rapidly.
Slovenian: Takoj po porodu se potreba po insulinu hitro zmanjša.
English: The absolute bioavailability (70%) of insulin glulisine was similar between injection sites and of low intra-subject variability (11% CV).
Slovenian: Absolutna biološka uporabnost (70 %) insulina glulisin je bila med mesti injiciranja podobna in je imela majhno intraindividualno variabilnost (11 % KV).
English: These conditions can happen when there are problems with the infusion pump or when the pump system is used incorrectly.
Slovenian: Ta stanja se lahko pojavijo, če so težave z infuzijsko črpalko ali če sistem s črpalko ni pravilno uporabljen.
English: Prior to each injection a safety test has to be performed to ensure that pen and needle work properly and to remove air bubbles.
Slovenian: Pred vsakim injiciranjem morate opraviti varnostni preizkus, da zagotovite pravilno delovanje injekcijskega peresnika in igle in da odstranite zračne mehurčke.
English: Side effects where the frequency cannot be estimated from the available data
Slovenian: Neželeni učinki kjer pogostnosti iz razpoložljivih podatkov ni mogoče oceniti
English: Dose proportionality
Slovenian: Sorazmernost odmerka
English: Patients using CSII should be comprehensively instructed on the use of the pump system.
Slovenian: Bolnike, ki uporabljajo CSII, je treba izčrpno poučiti o uporabi sistema s črpalko.
English: Changes in strength, brand (manufacturer), type (regular, neutral protamine Hagedorn [NPH], lente, long-acting, etc.), origin (animal, human, human insulin analogue) and/or method of manufacture may result in the need for a change in dose.
Slovenian: Spremembe v jakosti, znamki (izdelovalec), vrsti (navadni, nevtralni protamin hagedorn (NPH), lente, dolgo delujoči, itn.), izvoru (živalski, humani, analog humanega insulina) in/ali načinu izdelave lahko povzročijo spremembo v odmerku.
English: In the following situations, the management of your diabetes may require extra care: - If you are ill or have a major injury then your blood sugar level may increase (hyperglycaemia).
Slovenian: V sledečih okoliščinah lahko vodenje vaše sladkorne bolezni zahteva posebno skrb: Če ste bolni ali se huje poškodujete, se lahko koncentracija krvnega sladkorja zviša (hiperglikemija).
English: Insulin that you inject in such a site may not work very well.
Slovenian: Delovanje insulina, injiciranega na takšno mesto, morda ne bo ustrezno.
English: Apidra should be taken shortly (0-15 minutes) before or soon after meals.
Slovenian: Zdravilo Apidra je treba uporabiti kratek čas (0-15 minut) pred obroki ali kmalu po njih.
English: On the x-axis, zero (arrow) is the start of a 15-minute meal.
Slovenian: Na osi x označuje ničla (puščica) začetek 15-minutnega obroka.
English: Special caution must be taken when removing and disposing the needle.
Slovenian: Posebna previdnost je potrebna, ko iglo odstranjujete in zavržete.
English: Medication errors have been reported in which other insulins, particularly long-acting insulins, have been accidentally administered instead of insulin glulisine.
Slovenian: O napakah zdravljenja so poročali, ko so bili drugi insulini, posebno dolgo delujoči insulini, pomotoma aplicirani namesto insulina glulisin.
English: Diabetes mellitus is a disease where your body does not produce enough insulin to control the level of blood sugar.
Slovenian: Sladkorna bolezen je bolezen, pri kateri telo ne tvori dovolj insulina, da bi uravnal koncentracijo krvnega sladkorja.
English: The outer and inner needle caps should be removed.
Slovenian: Odstraniti morate zunanji in notranji pokrovček igle.
English: Based on your life-style and the results of your blood sugar (glucose) tests and your previous insulin usage, your doctor will determine how much Apidra you will need.
Slovenian: Zdravnik bo glede na vaš življenjski slog, izvide meritev vašega krvnega sladkorja (glukoze) in vašo prejšnjo porabo insulina določil, koliko insulina Apidra potrebujete.
English: The needle should be inserted into the skin.
Slovenian: Iglo je treba zabosti v kožo.
English: It is important that patients follow the Apidra specific instructions when using Apidra.
Slovenian: Pomembno je, da bolniki med uporabo zdravila Apidra upoštevajo specifična navodila za zdravilo Apidra.
English: Patients must be educated to use proper injection techniques.
Slovenian: Bolnike je treba naučiti pravilne tehnike injiciranja.
English: Step 3 Perform a safety test
Slovenian: 3. korak; Opravite varnostni preizkus
English: Other medicines and Apidra
Slovenian: Druga zdravila in zdravilo Apidra
English: Apidra is injected under the skin (subcutaneously).
Slovenian: Apidra se injicira pod kožo (subkutano).
English: If you have any questions about SoloStar or about diabetes, ask your doctor, pharmacist or nurse or call the local sanofi-aventis number on the front of this leaflet.
Slovenian: Če imate kakršna koli vprašanja o Apidri SoloStar ali o diabetesu, se posvetujte s svojim zdravnikom, s farmacevtom ali z medicinsko sestro ali pokličite lokalno sanofi aventis telefonsko številko na koncu navodila za uporabo.
English: If you are not able to use SoloStar or follow all the instructions completely on your own, you must use SoloStar only if you have help from a person who is able to follow the instructions completely.
Slovenian: Če vseh teh navodil ne morete popolnoma upoštevati vi sami, uporabite SoloStar le v primeru, da vam lahko pomaga oseba, ki lahko upošteva ta navodila.
English: If you use more Apidra than you should
Slovenian: Če ste uporabili večji odmerek zdravila Apidra, kot bi smeli
English: Apidra contains metacresol
Slovenian: Apidra vsebuje metakrezol
English: The dose of Apidra should be individually adjusted.
Slovenian: Odmerek insulina Apidra mora biti prilagojen individualno.
English: • If the needle is not kept straight while you attach it, it can damage the rubber seal and cause leakage, or break the needle.
Slovenian: • Če igle med nameščanjem ne držite naravnost, lahko poškoduje gumijasto zaporo in povzroči iztekanje, ali pa se igla poškoduje.
English: It is unknown whether insulin glulisine is excreted in human milk, but in general insulin does not pass into breast milk and is not absorbed after oral administration.
Slovenian: Ni znano, ali se insulin glulisin izloča v materinem mleku, a praviloma insulin ne prehaja v materino mleko in se po peroralni uporabi ne absorbira.
English: If no insulin appears at the needle tip, step 3 should be repeated until insulin appears at the needle tip.
Slovenian: Če se na konici igle ne pokaže insulin, morate ponavljati 3. korak, dokler se insulin ne pokaže na konici igle.
English: • Special caution must be taken to avoid accidental needle injury and transmission of infection.
Slovenian: • Posebej morate paziti, da boste preprečili naključne poškodbe z iglo in prenos okužbe.
English: Hypoglycaemia can become severe and may lead to unconsciousness and/or convulsions and may result in temporary or permanent impairment of brain function or even death.
Slovenian: Hipoglikemija lahko postane huda in povzroči nezavest in/ali konvulzije ter prehodno ali trajno okvaro delovanja možganov ali celo smrt.
English: Step 5 Inject the dose
Slovenian: Korak 5 Injicirajte odmerek
English: Empty pens must never be reused and must be properly discarded.
Slovenian: Praznih injekcijskih peresnikov se nikdar ne sme uporabiti in jih je treba ustrezno zavreči.
English: Interim subcutaneous injections with Apidra may be required.
Slovenian: Za vmesni čas je lahko potrebno subkutano injiciranje zdravila Apidra.
English: In patients with hepatic impairment, insulin requirements may be diminished due to reduced capacity for gluconeogenesis and reduced insulin metabolism.
Slovenian: Pri bolnikih z okvaro jeter se lahko potreba po insulinu zmanjša zaradi zmanjšane zmožnosti za glukoneogenezo in zmanjšane presnove insulina.
English: GLULISINE - pre REGULAR - pre
Slovenian: GLULISIN- pred NAVADNI - pred
English: These cartridges should not be used with any other reusable pen as the dosing accuracy has only been established with the listed pens (see section 4.2 and 6.6).
Slovenian: Ti vložki se ne smejo uporabljati z drugimi injekcijskimi peresniki za ponovno uporabo, ker je natančnost odmerjanja dokazana samo za omenjene injekcijske peresnike (glejte poglavji 4.2 in 6.6).
English: If your blood sugar level is too high, this tells you that you may need more insulin than you have injected.
Slovenian: Če imate preveliko koncentracijo krvnega sladkorja, to pomeni, da morda potrebujete več insulina, kot ste si ga injicirali.
English: Non-clinical data did not reveal toxicity findings others than those linked to the blood glucose lowering pharmacodynamic activity (hypoglycaemia), different from regular human insulin or of clinical relevance for humans.
Slovenian: Predklinični podatki o toksičnosti niso pokazali drugih izsledkov razen tistih, povezanih s farmakodinamičnim delovanjem na znižanje glukoze v krvi (hipoglikemija), ki bi bili drugačni od navadnega humanega insulina ali klinično pomembni za človeka.
English: Hypoglycaemia may occur as a result of an excess of insulin activity relative to food intake and energy expenditure.
Slovenian: Hipoglikemija se lahko pojavi zaradi čezmernega delovanja insulina glede na uživanje hrane in porabo energije.
English: • Do not select a dose and/or press the injection button without a needle attached.
Slovenian: • Ne izbirajte odmerka in/ali ne pritisnite gumba za injiciranje brez nameščene igle.
English: Insulin glulisine for intravenous use at a concentration of 1 Unit/ml is stable at room temperature for 48 hours.
Slovenian: Insulin glulisin za intravensko uporabo je v koncentraciji 1 enota/ml pri sobni temperaturi stabilen 48 ur.
English: Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Slovenian: Obvestite svojega zdravnika, če jemljete ali ste pred kratkim jemali katero koli drugo zdravilo.
English: Pump or infusion set problems or using the pump incorrectly can result in you not getting enough insulin.
Slovenian: Težave s črpalko ali kompletom za infundiranje ali nepravilna uporaba črpalke lahko povzročijo, da ne dobite dovolj insulina.
English: It has a rapid onset within 10-20 minutes and a short duration, about 4 hours.
Slovenian: Insulin glulisin začne delovati hitro, v roku 10-20 minut, njegovo delovanje pa je kratkotrajno, približno 4 ure.
English: These units are exclusive to Apidra and are not the same as IU or the units used to express the potency of other insulin analogues (see section 5.1).
Slovenian: Te enote veljajo izključno za zdravilo Apidra in niso enake mednarodnim enotam (i.e.) ali enotam, ki se uporabljajo za izražanje jakosti drugih insulinskih analogov (glejte poglavje 5.1).
English: A dose should not be selected and/or the injection button should not be pressed without a needle attached.
Slovenian: Odmerka ni potrebno izbrati in/ali gumba za injiciranje ne smemo pritisniti brez nameščene igle.
English: GIR - mg/kg/min
Slovenian: HIG - mg/kg/min
English: You must use the pen as described in these Instructions for use.
Slovenian: Injekcijski peresnik morate uporabljati, kot je opisano v teh navodilih za ravnanje.
English: Injection site reactions Local hypersensitivity reactions
Slovenian: Reakcije na mestu injiciranja Lokalne preobčutljivostne reakcije
English: If you think you may have a problem with SoloStar, please consult your Health Care Professional.
Slovenian: Če imate z injekcijskim peresnikom SoloStar kakšne težave, se posvetujte s svojim zdravstvenim delavcem.
English: A. MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Slovenian: A. IZDELOVALEC (IZDELOVALCI) BIOLOŠKE ZDRAVILNE UČINKOVINE (UČINKOVIN) IN IZDELOVALEC (IZDELOVALCI), ODGOVOREN (ODGOVORNI) ZA SPROŠČANJE SERIJE
English: What to do if the pump system fails or when the pump is used incorrectly
Slovenian: Kaj storiti, če sistem s črpalko odpove, ali če je črpalka nepravilno uporabljena?
English: Insulins lower blood glucose levels by stimulating peripheral glucose uptake, especially by skeletal muscle and fat, and by inhibiting hepatic glucose production.
Slovenian: Insulini znižujejo koncentracijo glukoze v krvi s spodbujanjem perifernega privzema glukoze, zlasti v skeletnih mišicah in maščevju, ter z zaviranjem tvorbe glukoze v jetrih.
English: Uncorrected hypoglycaemic or hyperglycaemic reactions can cause loss of consciousness, coma, or death.
Slovenian: Nekorigirane hipo- ali hiperglikemične reakcije lahko povzročijo nezavest, komo ali smrt.
English: Insulin glulisine is produced by recombinant DNA technology in Escherichia coli.
Slovenian: Insulin glulisin je pridobljen s tehnologijo rekombinantne DNA iz bakterij Escherichia coli.
English: The mean residence time of insulin glulisine was shorter (98 min) than for regular human insulin (161 min) (see figure 3).
Slovenian: Povprečni rezidenčni čas je bil pri insulinu glulisin krajši (98 minut) kot pri navadnem humanem insulinu (161 minut) (slika 3).
English: These instructions may differ from the instructions that come with your insulin infusion pump.
Slovenian: Ta navodila se lahko razlikujejo od navodil, ki so priložena vaši črpalki za infundiranje insulina.
English: The outside of the SoloStar can be cleaned by wiping it with a damp cloth.
Slovenian: Zunanjost SoloStarja lahko očistite tako, da ga obrišete z vlažno krpico.
English: Apidra was found to be incompatible with Glucose 5% solution and Ringer's solution and, therefore, must not be used with these solution fluids.
Slovenian: Ugotovljeno je, da je zdravilo Apidra inkompatibilno s 5 % raztopino glukoze in z Ringerjevo raztopino, zato se ga ne sme uporabljati s tema raztopinama.
English: The pharmacokinetic and pharmacodynamic properties of insulin glulisine were investigated in children (7-11 years) and adolescents (12-16 years) with type 1 diabetes mellitus.
Slovenian: Farmakokinetične in farmakodinamične lastnosti insulina glulisin so raziskali pri otrocih (7-11 let) in mladostnikih (12-16 let) z diabetesom mellitusom tipa 1.
English: However, insulin requirements may be reduced in the presence of renal impairment (see section 5.2).
Slovenian: Lahko pa se pri okvari ledvic zmanjša potreba po insulinu (glejte poglavje 5.2).
English: Before taking a medicine ask your doctor if it can affect your blood sugar level and what action, if any, you need to take.
Slovenian: Preden uporabite zdravilo, zdravnika vprašajte, ali lahko vpliva na krvni sladkor, ali je v zvezi s tem potrebno kakšno posebno ravnanje in če, kakšno.
English: The rate of absorption, and consequently the onset and duration of action, may be affected by the injection site, exercise and other variables.
Slovenian: Na hitrost absorpcije in s tem na začetek in trajanje delovanja lahko vplivajo mesto injiciranja, telesna dejavnost in drugi dejavniki.
English: Insulin glulisine
Slovenian: Insulin glulisin.
English: Combination of Apidra with pioglitazone
Slovenian: Kombinacija zdravila Apidra s pioglitazonom
English: See the box at the end of this leaflet for important further information about hypoglycaemia and its treatment.
Slovenian: V okviru na koncu tega navodila za uporabo boste našli pomembne dodatne informacije o hipoglikemiji in njenem zdravljenju.
English: The use of inadequate doses or discontinuation of treatment, especially in insulin-dependent diabetic, may lead to hyperglycaemia and diabetic ketoacidosis; conditions which are potentially lethal.
Slovenian: Uporaba nezadostnih odmerkov ali prekinitev zdravljenja lahko, zlasti pri diabetikih, odvisnih od insulina, povzroči hiperglikemijo in diabetično ketoacidozo; obe sta lahko usodni.
English: Some patients with long-standing type 2 diabetes mellitus and heart disease or previous stroke who were treated with pioglitazone and insulin experienced the development of heart failure.
Slovenian: Nekateri bolniki, ki imajo dolgotrajen diabetes mellitus tipa 2 in srčno obolenje ali so doživeli srčno kap ter so bili sočasno zdravljeni s pioglitazonom in insulinom, so doživeli razvoj srčnega popuščanja.
English: Hypoglycaemia (low blood sugar) can be very serious.
Slovenian: Hipoglikemija (nizek krvni sladkor) je lahko zelo resna.
English: Pharmacokinetic profiles in healthy volunteers and diabetes patients (type 1 or 2) demonstrated that absorption of insulin glulisine was about twice as fast with a peak concentration approximately twice as high as compared to regular human insulin.
Slovenian: Farmakokinetične značilnosti pri zdravih prostovoljcih in bolnikih z diabetesom (tipa 1 ali 2) kažejo, da je absorpcija insulina glulisin približno dvakrat tako hitra, najvišja koncentracija pa približno dvakrat tako visoka kot pri navadnem humanem insulinu.
English: Never use the solution if it has become cloudy or contains particles; use it only if it is clear and colourless.
Slovenian: Raztopine ne smete nikdar uporabiti, če je motna ali vsebuje delce; uporabite jo le, če je bistra in brezbarvna.
English: Systemic hypersensitivity reactions
Slovenian: Sistemske preobčutljivostne reakcije
English: Your ability to concentrate or react may be reduced if: - you have hypoglycaemia (low blood sugar levels), - you have hyperglycaemia (high blood sugar levels).
Slovenian: Vaša sposobnost koncentracije ali reagiranja se vam lahko zmanjša, če: imate hipoglikemijo (nizko koncentracijo krvnega sladkorja), imate hiperglikemijo (visoko koncentracijo krvnega sladkorja).
English: Subcutaneous injection in the abdominal wall ensures a slightly faster absorption than other injection sites (see section 5.2).
Slovenian: Absorpcija je po subkutani injekciji v trebušno steno nekoliko hitrejša kot z drugih mest injiciranja (glejte poglavje 5.2).
English: - If your blood sugar is too low (hypoglycaemia), follow the guidance for hypoglycaemia (see box at the end of this leaflet).
Slovenian: • Če imate prenizek krvni sladkor (hipoglikemijo), upoštevajte navodila za ravnanje v primeru hipoglikemije (glejte okvir na koncu tega navodila za uporabo).
English: Follow recommended safety measures for removal and disposal of needles (contact your doctor, pharmacist or nurse) in order to reduce the risk of accidental needle injury and transmission of infectious diseases.
Slovenian: Upoštevajte priporočene varnostne ukrepe za odstranjevanje in odlaganje igel (obrnite se na zdravnika, farmacevta ali medicinsko sestro), da bi zmanjšali tveganje za naključno poškodbo z iglo in prenos nalezljivih bolezni.
English: Prompt identification and correction of the cause of hyperglycaemia or ketosis or diabetic ketoacidosis is necessary.
Slovenian: Potrebna je takojšnja prepoznava in odprava vzroka hiperglikemije, ketoze ali diabetične ketoacidoze.