natgillin/translations-raw huggingface dataset:
• Before each use, a new needle must always be carefully attached and a safety test must be performed.
• Pred vsako uporabo morate natančno namestiti novo iglo in opraviti varnostni preizkus.
Insulin requirements may be altered during illness or emotional disturbances.
Potreba po insulinu se lahko spremeni med boleznijo ali čustvenimi obremenitvami.
Immediately after delivery, insulin requirements decline rapidly.
Takoj po porodu se potreba po insulinu hitro zmanjša.
The absolute bioavailability (70%) of insulin glulisine was similar between injection sites and of low intra-subject variability (11% CV).
Absolutna biološka uporabnost (70 %) insulina glulisin je bila med mesti injiciranja podobna in je imela majhno intraindividualno variabilnost (11 % KV).
These conditions can happen when there are problems with the infusion pump or when the pump system is used incorrectly.
Ta stanja se lahko pojavijo, če so težave z infuzijsko črpalko ali če sistem s črpalko ni pravilno uporabljen.
Prior to each injection a safety test has to be performed to ensure that pen and needle work properly and to remove air bubbles.
Pred vsakim injiciranjem morate opraviti varnostni preizkus, da zagotovite pravilno delovanje injekcijskega peresnika in igle in da odstranite zračne mehurčke.
Side effects where the frequency cannot be estimated from the available data
Neželeni učinki kjer pogostnosti iz razpoložljivih podatkov ni mogoče oceniti
Dose proportionality
Sorazmernost odmerka
Patients using CSII should be comprehensively instructed on the use of the pump system.
Bolnike, ki uporabljajo CSII, je treba izčrpno poučiti o uporabi sistema s črpalko.
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.
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.
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).
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).
Insulin that you inject in such a site may not work very well.
Delovanje insulina, injiciranega na takšno mesto, morda ne bo ustrezno.
Apidra should be taken shortly (0-15 minutes) before or soon after meals.
Zdravilo Apidra je treba uporabiti kratek čas (0-15 minut) pred obroki ali kmalu po njih.
On the x-axis, zero (arrow) is the start of a 15-minute meal.
Na osi x označuje ničla (puščica) začetek 15-minutnega obroka.
Special caution must be taken when removing and disposing the needle.
Posebna previdnost je potrebna, ko iglo odstranjujete in zavržete.
Medication errors have been reported in which other insulins, particularly long-acting insulins, have been accidentally administered instead of insulin glulisine.
O napakah zdravljenja so poročali, ko so bili drugi insulini, posebno dolgo delujoči insulini, pomotoma aplicirani namesto insulina glulisin.
Diabetes mellitus is a disease where your body does not produce enough insulin to control the level of blood sugar.
Sladkorna bolezen je bolezen, pri kateri telo ne tvori dovolj insulina, da bi uravnal koncentracijo krvnega sladkorja.
The outer and inner needle caps should be removed.
Odstraniti morate zunanji in notranji pokrovček igle.
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.
Zdravnik bo glede na vaš življenjski slog, izvide meritev vašega krvnega sladkorja (glukoze) in vašo prejšnjo porabo insulina določil, koliko insulina Apidra potrebujete.
The needle should be inserted into the skin.
Iglo je treba zabosti v kožo.
It is important that patients follow the Apidra specific instructions when using Apidra.
Pomembno je, da bolniki med uporabo zdravila Apidra upoštevajo specifična navodila za zdravilo Apidra.
Patients must be educated to use proper injection techniques.
Bolnike je treba naučiti pravilne tehnike injiciranja.
Step 3 Perform a safety test
3. korak; Opravite varnostni preizkus
Other medicines and Apidra
Druga zdravila in zdravilo Apidra
Apidra is injected under the skin (subcutaneously).
Apidra se injicira pod kožo (subkutano).
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.
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.
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.
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.
If you use more Apidra than you should
Če ste uporabili večji odmerek zdravila Apidra, kot bi smeli
Apidra contains metacresol
Apidra vsebuje metakrezol
The dose of Apidra should be individually adjusted.
Odmerek insulina Apidra mora biti prilagojen individualno.
• If the needle is not kept straight while you attach it, it can damage the rubber seal and cause leakage, or break the needle.
• Če igle med nameščanjem ne držite naravnost, lahko poškoduje gumijasto zaporo in povzroči iztekanje, ali pa se igla poškoduje.
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.
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.
If no insulin appears at the needle tip, step 3 should be repeated until insulin appears at the needle tip.
Če se na konici igle ne pokaže insulin, morate ponavljati 3. korak, dokler se insulin ne pokaže na konici igle.
• Special caution must be taken to avoid accidental needle injury and transmission of infection.
• Posebej morate paziti, da boste preprečili naključne poškodbe z iglo in prenos okužbe.
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.
Hipoglikemija lahko postane huda in povzroči nezavest in/ali konvulzije ter prehodno ali trajno okvaro delovanja možganov ali celo smrt.
Step 5 Inject the dose
Korak 5 Injicirajte odmerek
Empty pens must never be reused and must be properly discarded.
Praznih injekcijskih peresnikov se nikdar ne sme uporabiti in jih je treba ustrezno zavreči.
Interim subcutaneous injections with Apidra may be required.
Za vmesni čas je lahko potrebno subkutano injiciranje zdravila Apidra.
In patients with hepatic impairment, insulin requirements may be diminished due to reduced capacity for gluconeogenesis and reduced insulin metabolism.
Pri bolnikih z okvaro jeter se lahko potreba po insulinu zmanjša zaradi zmanjšane zmožnosti za glukoneogenezo in zmanjšane presnove insulina.
GLULISINE - pre REGULAR - pre
GLULISIN- pred NAVADNI - pred
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).
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).
If your blood sugar level is too high, this tells you that you may need more insulin than you have injected.
Če imate preveliko koncentracijo krvnega sladkorja, to pomeni, da morda potrebujete več insulina, kot ste si ga injicirali.
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.
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.
Hypoglycaemia may occur as a result of an excess of insulin activity relative to food intake and energy expenditure.
Hipoglikemija se lahko pojavi zaradi čezmernega delovanja insulina glede na uživanje hrane in porabo energije.
• Do not select a dose and/or press the injection button without a needle attached.
• Ne izbirajte odmerka in/ali ne pritisnite gumba za injiciranje brez nameščene igle.
Insulin glulisine for intravenous use at a concentration of 1 Unit/ml is stable at room temperature for 48 hours.
Insulin glulisin za intravensko uporabo je v koncentraciji 1 enota/ml pri sobni temperaturi stabilen 48 ur.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Obvestite svojega zdravnika, če jemljete ali ste pred kratkim jemali katero koli drugo zdravilo.
Pump or infusion set problems or using the pump incorrectly can result in you not getting enough insulin.
Težave s črpalko ali kompletom za infundiranje ali nepravilna uporaba črpalke lahko povzročijo, da ne dobite dovolj insulina.
It has a rapid onset within 10-20 minutes and a short duration, about 4 hours.
Insulin glulisin začne delovati hitro, v roku 10-20 minut, njegovo delovanje pa je kratkotrajno, približno 4 ure.
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).
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).
A dose should not be selected and/or the injection button should not be pressed without a needle attached.
Odmerka ni potrebno izbrati in/ali gumba za injiciranje ne smemo pritisniti brez nameščene igle.
GIR - mg/kg/min
HIG - mg/kg/min
You must use the pen as described in these Instructions for use.
Injekcijski peresnik morate uporabljati, kot je opisano v teh navodilih za ravnanje.
Injection site reactions Local hypersensitivity reactions
Reakcije na mestu injiciranja Lokalne preobčutljivostne reakcije
If you think you may have a problem with SoloStar, please consult your Health Care Professional.
Če imate z injekcijskim peresnikom SoloStar kakšne težave, se posvetujte s svojim zdravstvenim delavcem.
A. MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
A. IZDELOVALEC (IZDELOVALCI) BIOLOŠKE ZDRAVILNE UČINKOVINE (UČINKOVIN) IN IZDELOVALEC (IZDELOVALCI), ODGOVOREN (ODGOVORNI) ZA SPROŠČANJE SERIJE
What to do if the pump system fails or when the pump is used incorrectly
Kaj storiti, če sistem s črpalko odpove, ali če je črpalka nepravilno uporabljena?
Insulins lower blood glucose levels by stimulating peripheral glucose uptake, especially by skeletal muscle and fat, and by inhibiting hepatic glucose production.
Insulini znižujejo koncentracijo glukoze v krvi s spodbujanjem perifernega privzema glukoze, zlasti v skeletnih mišicah in maščevju, ter z zaviranjem tvorbe glukoze v jetrih.
Uncorrected hypoglycaemic or hyperglycaemic reactions can cause loss of consciousness, coma, or death.
Nekorigirane hipo- ali hiperglikemične reakcije lahko povzročijo nezavest, komo ali smrt.
Insulin glulisine is produced by recombinant DNA technology in Escherichia coli.
Insulin glulisin je pridobljen s tehnologijo rekombinantne DNA iz bakterij Escherichia coli.
The mean residence time of insulin glulisine was shorter (98 min) than for regular human insulin (161 min) (see figure 3).
Povprečni rezidenčni čas je bil pri insulinu glulisin krajši (98 minut) kot pri navadnem humanem insulinu (161 minut) (slika 3).
These instructions may differ from the instructions that come with your insulin infusion pump.
Ta navodila se lahko razlikujejo od navodil, ki so priložena vaši črpalki za infundiranje insulina.
The outside of the SoloStar can be cleaned by wiping it with a damp cloth.
Zunanjost SoloStarja lahko očistite tako, da ga obrišete z vlažno krpico.
Apidra was found to be incompatible with Glucose 5% solution and Ringer's solution and, therefore, must not be used with these solution fluids.
Ugotovljeno je, da je zdravilo Apidra inkompatibilno s 5 % raztopino glukoze in z Ringerjevo raztopino, zato se ga ne sme uporabljati s tema raztopinama.
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.
Farmakokinetične in farmakodinamične lastnosti insulina glulisin so raziskali pri otrocih (7-11 let) in mladostnikih (12-16 let) z diabetesom mellitusom tipa 1.
However, insulin requirements may be reduced in the presence of renal impairment (see section 5.2).
Lahko pa se pri okvari ledvic zmanjša potreba po insulinu (glejte poglavje 5.2).
Before taking a medicine ask your doctor if it can affect your blood sugar level and what action, if any, you need to take.
Preden uporabite zdravilo, zdravnika vprašajte, ali lahko vpliva na krvni sladkor, ali je v zvezi s tem potrebno kakšno posebno ravnanje in če, kakšno.
The rate of absorption, and consequently the onset and duration of action, may be affected by the injection site, exercise and other variables.
Na hitrost absorpcije in s tem na začetek in trajanje delovanja lahko vplivajo mesto injiciranja, telesna dejavnost in drugi dejavniki.
Insulin glulisine
Insulin glulisin.
Combination of Apidra with pioglitazone
Kombinacija zdravila Apidra s pioglitazonom
See the box at the end of this leaflet for important further information about hypoglycaemia and its treatment.
V okviru na koncu tega navodila za uporabo boste našli pomembne dodatne informacije o hipoglikemiji in njenem zdravljenju.
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.
Uporaba nezadostnih odmerkov ali prekinitev zdravljenja lahko, zlasti pri diabetikih, odvisnih od insulina, povzroči hiperglikemijo in diabetično ketoacidozo; obe sta lahko usodni.
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.
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.
Hypoglycaemia (low blood sugar) can be very serious.
Hipoglikemija (nizek krvni sladkor) je lahko zelo resna.
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.
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.
Never use the solution if it has become cloudy or contains particles; use it only if it is clear and colourless.
Raztopine ne smete nikdar uporabiti, če je motna ali vsebuje delce; uporabite jo le, če je bistra in brezbarvna.
Systemic hypersensitivity reactions
Sistemske preobčutljivostne reakcije
Your ability to concentrate or react may be reduced if: - you have hypoglycaemia (low blood sugar levels), - you have hyperglycaemia (high blood sugar levels).
Vaša sposobnost koncentracije ali reagiranja se vam lahko zmanjša, če: imate hipoglikemijo (nizko koncentracijo krvnega sladkorja), imate hiperglikemijo (visoko koncentracijo krvnega sladkorja).
Subcutaneous injection in the abdominal wall ensures a slightly faster absorption than other injection sites (see section 5.2).
Absorpcija je po subkutani injekciji v trebušno steno nekoliko hitrejša kot z drugih mest injiciranja (glejte poglavje 5.2).
- If your blood sugar is too low (hypoglycaemia), follow the guidance for hypoglycaemia (see box at the end of this leaflet).
• Če imate prenizek krvni sladkor (hipoglikemijo), upoštevajte navodila za ravnanje v primeru hipoglikemije (glejte okvir na koncu tega navodila za uporabo).
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.
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.
Prompt identification and correction of the cause of hyperglycaemia or ketosis or diabetic ketoacidosis is necessary.
Potrebna je takojšnja prepoznava in odprava vzroka hiperglikemije, ketoze ali diabetične ketoacidoze.
In this study, the majority of patients (79%) mixed their short acting insulin with NPH insulin immediately prior to injection and 58% of subjects used oral hypoglycaemic agents at randomization and were instructed to continue to use them at the same dose.
Večina bolnikov (79 %) v tej študiji je kratkodelujoči insulin tik pred injiciranjem zmešala z insulinom NPH, 58% preiskovancev pa je ob randomizaciji uporabljalo peroralne antidiabetike in so dobili navodilo, naj jih v enakem odmerku uporabljajo še naprej.
Beta-blockers like other sympatholytic medicines (such as clonidine, guanethidine and reserpine) may weaken or suppress entirely the first warning symptoms which help you to recognise a hypoglycaemia.
Zaviralci adrenergičnih receptorjev beta lahko, tako kot druga simpatikolitična zdravila (kot so klonidin, gvanetidin in reserpin), oslabijo ali popolnoma preprečijo prve opozorilne simptome, ki vam pomagajo prepoznati hipoglikemijo.
Insulin glulisine for intravenous use at a concentration of 1 Unit/ml is stable between 15°C and 25°C for 48 hours (see section 6.6).
Insulin glulisin za intravensko uporabo je v koncentraciji 1 enota/ml pri temperaturi od 15°C do 25°C stabilen 48 ur (glejte poglavje 6.6).
Step 1 Check the insulin
1. korak; Preverite insulin
Apidra is a short-acting insulin.
Apidra je kratkodelujoč insulin.
The glucose excursion (AUC 0-6h) was 641 mg.h.dl-1 for insulin glulisine and 801 mg.h.dl-1 for regular human insulin.
Ekskurz glukoze (AUC 0-6h) je bil pri insulinu glulisin 641 mg.h.dl-1 in pri navadnem humanem insulinu 801 mg.h.dl-1.
Needles must not be reused.
Igel ne smete ponovno uporabiti.
Severe hypoglycaemic episodes, where the patient has become unconscious, can be treated by glucagon (0.5 mg to 1 mg) given intramuscularly or subcutaneously by a person who has received appropriate instruction, or by glucose given intravenously by a healthcare professional.
Hude hipoglikemije, ko je bolnik nezavesten, je mogoče zdraviti z intramuskularno ali subkutano injekcijo glukagona (0,5 mg do 1 mg), ki jo da ustrezno usposobljena oseba, ali z intravensko injekcijo glukoze, ki jo da zdravstveni delavec.
Figure 1B
slika 1B
Do not use Apidra
Ne uporabljajte zdravila Apidra
If you think you may have a problem with Apidra, have it checked by your doctor or pharmacist.
Če se vam zdi, da imate težave z zdravilom Apidra, naj ga pregleda vaš zdravnik ali farmacevt.
These are serious side effects.
To so resni neželeni učinki.
Detailed information on this product is available on the website of the European Medicines Agency http://www.ema.europa.eu/
DATUM ZADNJE REVIZIJE BESEDILA Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila http://www.ema.europa.eu/
If your blood sugar level starts to rise, contact your doctor, pharmacist or nurse as soon as possible.
Če se vam začne krvni sladkor zviševati, se čim prej posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
Keep this possible problem in mind in all situations where you might put yourself and others at risk (such as driving a car or using machines).
Ne pozabite na to v okoliščinah, v katerih bi lahko ogrozili sebe in druge (kot je vožnja avtomobila ali upravljanje strojev).
However, hypoglycaemia may develop over sequential stages.
A hipoglikemija se lahko razvije v dveh zaporednih stopnjah:
Hypoglycaemia, the most frequent adverse reaction of insulin therapy, may occur if the insulin dose is too high in relation to the insulin requirement.
Hipoglikemija, ki je najpogostejši neželeni učinek zdravljenja z insulinom, se pojavi, če je odmerek insulina prevelik glede na potrebo po insulinu.
Step 4 Select the dose
Korak 4 Izberite odmerek
The used SoloStar must be discarded as required by your local authorities.
Porabljeni SoloStar morate zavreči v skladu z lokalnimi predpisi.
Apidra is a clear insulin.
Apidra je bister insulin.
The primary activity of insulins and insulin analogues, including insulin glulisine, is regulation of glucose metabolism.
Temeljno delovanje insulinov in insulinskih analogov, tudi insulina glulisin, je uravnavanje presnove glukoze.
In insulin glulisine the replacement of the human insulin amino acid asparagine in position B3 by lysine and the lysine in position B29 by glutamic acid favours more rapid absorption.
V insulinu glulisin je aminokislina asparagin na položaju B3 humanega insulina nadomeščena z lizinom, lizin na položaju B29 pa z glutaminsko kislino; to zagotavlja hitrejšo absorpcijo.
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.
Z zdravnikom se pogovorite glede vožnje, če: - imate pogoste hipoglikemije, - so prvi opozorilni znaki hipoglikemije šibki ali jih sploh nimate.
The infusion set and reservoir used with Apidra must be changed at least every 48 hours using aseptic technique.
Komplet za infundiranje in rezervoar, ki se uporabljata z zdravilom Apidra, je treba zamenjati vsaj na 48 ur; pri tem je treba uporabljati aseptičen postopek.
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products except NPH human insulin.
Zaradi pomanjkanja študij kompatibilnosti, tega zdravila ne smemo mešati z drugimi zdravili razen s humanim insulinom NPH.
When you use Apidra in the pump system, it is important that you always follow these specific instructions.
Če uporabljate zdravilo Apidra v sistemu s črpalko, je pomembno, da vedno upoštevate specifična navodila za zdravilo Apidra.
Special patient groups If you have liver or kidney problems, speak to your doctor as you may need a lower dose.
Pogovorite se z zdravnikom, če imate težave z jetri ali ledvicami, ker morda potrebujete nižji odmerek.
Apidra 100 Units/ml solution for injection in a vial For further details on handling, see section 6.6.
Apidra 100 enot/ml raztopina za injiciranje v viali Za dodatne podrobnosti o ravnanju glejte poglavje 6.6.
Figure 1C
slika 1C
Mixing with insulins
Mešanje z insulini
Hyperglycaemia (potentially leading to Diabetic ketoacidosis(1))
Hiperglikemija (ki lahko vodi v diabetično ketoacidozo
If you switch from another insulin to insulin glulisine, your dosage may have to be adjusted by your doctor.
Če na insulin glulisin preidete z drugega insulina, vam bo zdravnik morda moral prilagoditi odmerek.
You should always have an alternative insulin delivery system available for injection under the skin in case the pump system fails.
Vedno morate imeti na voljo še drug insulin za injiciranje pod kožo za primer, da sistem s črpalko odpove.