natgillin/translations-raw huggingface dataset:
Insulins have no specific overdose definitions because serum glucose concentrations are a result of complex interactions between insulin levels, glucose availability and other metabolic processes.
Za insulinske pripravke nimamo specifične opredelitve prevelikega odmerjanja, ker so serumske koncentracije glukoze rezultat kompleksnih medsebojnih vplivov med ravnmi insulina, razpoložljivostjo glukoze in drugimi presnovnimi procesi.
Insulin lispro has been shown to be equipotent to human insulin on a molar basis but its effect is more rapid and of a shorter duration.
Za insulin lispro je bilo dokazano, da je na molarni osnovi enako močan kot humani insulin, a je njegov učinek hitrejši in bolj kratkotrajen.
Use of injection sites should be rotated so that the same site is not used more than approximately once a month.
Mesta injiciranja je treba menjati, tako da istega mesta ne uporabimo večkrat kot približno enkrat mesečno.
• Additional risk minimisation measures (Liprolog 200 units/ml)
• Dodatni ukrepi za zmanjševanje tveganj (Liprolog 200 enot/ml)
• somatostatin analogues (such as octreotide, used to treat an uncommon condition in which you make too much growth hormone),
• analoge somatostatina (npr. oktreotid, ki se uporablja za zdravljenje redke bolezni, pri kateri proizvajate preveč rastnega hormona),
Hypoglycaemia may occur as a result of an excess of insulin activity relative to food intake and energy expenditure.
Hipoglikemija lahko nastopi kot posledica čezmernega delovanja insulina glede na vnos hrane in porabo energije.
Do not shake vigorously as this may cause frothing which may interfere with the correct measurement of the dose.
Ne stresajte močno, ker lahko to povzroči penjenje, ki lahko ovira pravilno odmerjanje odmerka.
• It is normal to see a small amount of insulin left in the Pen that you can not inject.
• Povsem normalno je, da v peresniku vidite majhno količino preostalega insulina, ki ga ni mogoče vbrizgati.
Your insulin needs may change if you are taking
Vaše potrebe po insulinu se lahko spremenijo, če jemljete
• you have an infection or illness (especially diarrhoea or vomiting);
•imate okužbo ali zbolite (še posebej driska ali bruhanje);
• you have trouble with your kidneys or liver which gets worse.
•imate težave z ledvicami ali jetri in se stanje poslabša.
• Do not use your Pen past the expiration date printed on the Label or for more than 28 days after you first start using the Pen.
• Ne uporabljajte svojega peresnika po preteku roka uporabnosti, ki je natisnjen na oznaki, ali več kot 28 dni po prvi uporabi.
• Throw away the Pen you are using after 28 days, even if it still has insulin left in it.
• Peresnik, ki ga uporabljate, zavrzite po 28 dneh, tudi če je v njem še insulin.
You should never mix Liprolog with insulins produced by other manufacturers or animal insulins.
Nikoli pa ne smete mešati zdravila Liprolog z insulini drugih izdelovalcev ali z živalskimi insulini.
A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE
A. IZDELOVALCI BIOLOŠKE ZDRAVILNE UČINKOVINE IN IZDELOVALCI, ODGOVORNI ZA SPROŠČANJE SERIJE
• you exercise or work too hard just before or after a meal;
•ste telesno preveč dejavni ali preveč delate tik pred obrokom ali po njem;
• Do not use your Pen if any part looks broken or damaged.
• Ne uporabljajte peresnika, če je kateri koli njegov del videti zlomljen ali okvarjen.
The Junior KwikPen is blue.
Peresnik Junior KwikPen je modre barve.
Step 2: (For LIPROLOG suspensions cloudy insulins only)
Korak 2: (samo za motne insuline v suspenziji LIPROLOG)
How to recognize your KwikPen:
Kako prepoznati svoj peresnik KwikPen:
0.63 units/kg
0,63 enote/kg
• Check the appearance of the insulin.
• Preverite videz insulina.
• If you need to inject more than the number of units left in the Pen, you may either:
• Če si morate injicirati večje število enot, kot vam jih je še ostalo v peresniku, lahko bodisi:
Patients using vials must never share needles or syringes.
Bolniki, ki uporabljajo viale, si ne smejo deliti igel ali brizg med seboj.
The MAH shall ensure that healthcare professionals are informed that all patients who have been prescribed Liprolog should be trained on the correct use of the pre-filled pen before prescribing or dispensing Liprolog.
Imetnik dovoljenja za promet z zdravilom bo zagotovil, da bodo zdravstveni delavci obveščeni, da morajo biti vsi bolniki, ki jim je bilo predpisano zdravilo Liprolog, usposobljeni za pravilno uporabo napolnjenega peresnika, preden jim bo zdravilo Liprolog predpisano ali izdano.
It may cause a rash over the whole body, shortness of breath, wheezing, reduction in blood pressure, fast pulse, or sweating.
Povzroči lahko izpuščaj po vsem telesu, težko dihanje, piskanje v pljučih, padec krvnega tlaka, tahikardijo ali znojenje.
• Key features of the design of the package and pre-filled pen device
• Ključne lastnosti zasnove pakiranja in napolnjenega peresnika.
• KwikPen containing your insulin
• peresnik KwikPen, ki vsebuje vašo vrsto insulina
• Your doctor will tell you if you have to mix Liprolog with one of the human insulins.
• Zdravnik vam bo povedal, ali morate zdravilo Liprolog mešati s katerim od humanih insulinov.
The pharmacokinetics of insulin lispro reflect a compound that is rapidly absorbed, and achieves peak blood levels 30 to 70 minutes following subcutaneous injection.
Farmakokinetika insulina lispro kaže na spojino, ki se hitro absorbira in doseže najvišjo raven v krvi 30 do 70 minut po subkutanem injiciranju.
Pack of 1 and 2
Pakiranji po 1 ali 2
Reduction of the mean of combined morning / evening two-hour postprandial blood glucose
Zmanjšanje srednje, kombinirane jutranje/večerne vrednosti glukoze v krvi
Please tell your doctor, if you are taking or have recently taken any other medicines, including medicines obtained without a prescription (see section “Warnings and precautions”).
Obvestite svojega zdravnika, če jemljete ali ste pred kratkim jemali katerokoli zdravilo, tudi če ste ga dobili brez recepta (glejte poglavje “Opozorila in previdnostni ukrepi”).
Intravenous injection of insulin lispro should be carried out following normal clinical practise for intravenous injections, for example by an intravenous bolus or by an infusion system.
Intravensko injiciranje insulina lispro naj se izvaja v skladu z običajno klinično prakso za intravensko injiciranje, na primer z intravenskim bolusom ali z infuzijskim sistemom.
Names and addresses of the manufacturers of the biological active substance
Ime in naslov izdelovalcev biološke zdravilne učinkovine
• Do not freeze your insulin.
• Svojega insulina ne zamrzujte.
Insulin requirements usually fall during the first trimester and increase during the second and third trimesters.
Potrebe po insulinu običajno upadejo v prvem trimesečju nosečnosti in se povečajo v drugem in tretjem trimesečju.
Pack of 5 and 10
Pakiranji po 5 in 10
Discard after 28 days even if some of the solution remains.
Po 28 dneh jih zavrzite, tudi če v njih ostane še nekaj raztopine.
Only your physician can administer Liprolog by the intravenous route.
Samo zdravnik vam lahko da zdravilo Liprolog intravensko.
In two 8-month open label crossover studies, type 2 diabetes patients who were either new to insulin therapy or already using one or two injections of insulin, received 4 months of treatment with Liprolog Mix25 (used twice daily with metformin) and insulin glargine (used once daily with metformin) in a randomised sequence.
V dveh 8-mesečnih, odprtih, navzkrižnih študijah, so bolniki z diabetesom 2, ki so bodisi začeli zdravljenje z insulinom ali pa so že uporabljali eno ali dve injekciji insulina, 4 mesece v naključnem zaporedju prejemali zdravljenje z zdravilom Liprolog Mix25 (dvakrat na dan z metforminom) in insulinom glargin (enkrat na dan z metforminom).
You may need to get a prescription from your healthcare professional.
Morda boste potrebovali recept, ki vam ga bo napisal vaš zdravnik.
Please get rid of it carefully - your pharmacist or diabetes nurse will tell you how to do this.
Prosimo, zavrzite ga na ustrezen način - farmacevt ali medicinska sestra iz diabetološke ambulante vam bosta povedala, kako to storiti.
Paediatric population Liprolog can be used in adolescents and children (see section 5.1).
Zdravilo Liprolog se lahko uporablja pri mladostnikih in otrocih (glejte poglavje 5.1).
Insulin requirements and dosage adjustment
Potrebe po insulinu in prilagajanje odmerka
• Label: White with an orange colour bar and a grey colour band
• Oznaka: bela z oranžno vrstico in trakom sive barve
The MAH shall agree the final text of the Dear Healthcare Professional Communication letter and the content of the patient communication together with a communication plan, with the National Competent Authority in each Member State prior to launch of the product.
Imetnik dovoljenja za promet z zdravilom bo pred dajanjem zdravila na trg sprejel končno besedilo neposrednega obvestila zdravstvenim delavcem in vsebino informacij za bolnike ter načrt sporočanja, skupaj s pristojnim nacionalnim organom v vsaki državi članici.
Detailed information can be found in the following table.
Podrobne informacije so podane v spodnji preglednici.
If you are ill, especially if you feel sick or are sick, the amount of insulin you need may change.
Če ste bolni, še posebej, če vam je slabo ali bruhate, se lahko vaše potrebe po insulinu spremenijo.
It is essential to maintain good control of the insulin-treated (insulin-dependent or gestational diabetes) patient throughout pregnancy.
Dobra kontrola bolnic, ki se zdravijo z insulinom (od insulina odvisni ali gestacijski diabetes), je bistvenega pomena ves čas trajanja nosečnosti.
Therefore, the requirement for patients to self-inject is that they can read the dose counter on the pen.
Zato je predpogoj za bolnike, ki si želijo sami injicirati zdravilo, da zmorejo odčitati števec odmerkov peresnika.
If the combination is used, patients should be observed for signs and symptoms of heart failure, weight gain and oedema.
Pri uporabi te kombinacije je treba pri bolnikih opazovati znake in simptome srčnega popuščanja, pridobivanje telesne mase in prisotnost edema.
Insulin requirements may be increased during illness or emotional disturbances.
Potrebe po insulinu se lahko povečajo v času bolezni ali čustvenih težav.
This rapid onset of activity allows a Liprolog injection to be given very close to mealtime.
Ta hitri začetek delovanja omogoča, da si je injekcijo zdravila Liprolog mogoče dati časovno zelo blizu obroka.
PLEASE READ THIS USER MANUAL BEFORE USE
PRED UPORABO PREBERITE TA PRIROČNIK.
- if you think hypoglycaemia (low blood sugar) is starting.
− če mislite, da se začenja hipoglikemija (nizek krvni sladkor).
This will often get you over mild hypoglycaemia or a minor insulin overdose.
Pogosto vam bo tako uspelo odpraviti blago hipoglikemijo ali manjše preveliko odmerjanje insulina.
If you notice your skin thickening or pitting at the injection site, tell your doctor.
Če opazite zadebelitev kože ali vdolbino v koži na mestu injiciranja, na to opozorite svojega zdravnika.
Infusion systems at concentrations from 0.1 units/ml to 1.0 units/ml insulin lispro in 0.9% sodium chloride or 5% dextrose are stable at room temperature for 48 hours.
Infuzijski sistemi s koncentracijami od 0,1 enote/ml do 1,0 enote/ml insulina lispro v 0,9 % raztopini natrijevega klorida ali v 5 % dekstrozi so pri sobni temperaturi obstojni 48 ur.
The label is white with an orange colour bar and a grey colour band.
Oznaka je bela z oranžno vrstico in trakom sive barve.
0.42 units/kg
0,42 enote/kg
• Priming your Pen means removing the air from the Needle and Cartridge that may collect during normal use and ensures that the Pen is working correctly.
• Priprava peresnika pomeni, da ste iz igle in vložka odstranili ves zrak, ki se lahko nabere pri običajni uporabi; s tem zagotovite pravilno delovanje peresnika.
• Unscrew the capped Needle and dispose of it as described below (see Disposing of Pens and Needles section).
• Odvijte iglo s pokrovčkom in jo zavrzite, kot je opisano spodaj (glejte poglavje Odlaganje peresnikov in igel).
Do not change your insulin unless your doctor tells you to.
Ne menjajte svojega insulina, če vam ni tako svetoval zdravnik.
Before every injection, clear any air bubbles.
Pred vsakim injiciranjem odstranite morebitne zračne mehurčke.
Unscrew the capped Needle and dispose of it as described below (see Disposing of Pens and Needles section).
Odvijte iglo s pokrovčkom in jo zavrzite, kot je opisano spodaj (glejte poglavje Odlaganje peresnikov in igel).
Use the correct reservoir and catheter for the pump.
Uporabite ustrezen vsebnik in kateter za črpalko.
Severe cases of generalised allergy may be life-threatening.
V najhujših primerih je lahko generalizirana alergija smrtno nevarna.
• specific medicines to treat high blood pressure, kidney damage due to diabetes, and some heart problems (angiotensin II receptor blockers).
• specifična zdravila za zdravljenje visokega krvnega tlaka, poškodb ledvic zaradi sladkorne bolezni in nekaterih težav s srcem (blokatorji receptorjev angiotenzina II).
Liprolog is suitable for use in adults and children.
Zdravilo Liprolog je primerno za odrasle in otroke.
Pull the needle out and apply gentle pressure over the injection site for several seconds.
Izvlecite iglo in nekaj sekund nežno pritiskajte na mesto injiciranja.
• The odd numbers, after the number 1, are shown as full lines.
• Liha števila od številke 1 dalje so prikazana kot polne črte.
The MAH shall provide a Dear Healthcare Professional Letter (DHPC) and patient communication prior to launch targeting all physicians and nurses who are expected to be involved in the treatment and management of diabetic patients and, where required, all pharmacists who are expected to dispense Liprolog.
Imetnik dovoljenja za promet z zdravilom bo pred dajanjem na trg oblikoval neposredno obvestilo zdravstvenim delavcem (DHPC) in informacije za bolnike, ki bodo posredovani vsem zdravnikom in medicinskim sestram, za katere se pričakuje, da bodo vključeni v zdravljenje in obravnavo bolnikov s sladkorno boleznijo ter, po potrebi, vsem farmacevtom, za katere se pričakuje, da bodo izdajali zdravilo
- The half units are shown as lines between the numbers.
- Polovice so prikazane kot polne črtice med številkami.
Changes in strength, brand (manufacturer), type (regular/soluble, NPH/isophane, etc.), species (animal, human, human insulin analogue), and/or method of manufacture (recombinant DNA versus animal-source insulin) may result in the need for a change in dosage.
NPH/izofan itd.), vrste (živalski, humani, analog humanega insulina) in/ali načina izdelave (s pomočjo rekombinantne DNA v primerjavi z insulinom živalskega izvora) bo morda treba spremeniti odmerjanje insulina.
Mixing of the insulins ahead of time or just before the injection should be on advice of the physician.
Insuline naj se meša vnaprej ali tik pred injiciranjem, kakor svetuje zdravnik.
• difficulty in breathing
• težko dihanje,
If the patient is comatose, glucagon should be administered intramuscularly or subcutaneously.
Če je bolnik komatozen, damo glukagon intramuskularno ali subkutano.
• Prime your KwikPen before each use.
• Pred vsako uporabo svoj KwikPen pripravite.
Pen colour:
Barva peresnika:
Do not use this medicine after the expiry date which is stated on the label and the carton.
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na ovojnini in na škatli.
Getting the KwikPen ready to use (Please see user manual)
Priprava KwikPena za uporabo (prosimo, glejte Priročnik za uporabo)
Some pumps are compatible with cartridges that can be inserted intact into the pump.
Nekatere črpalke so združljive z vložki, ki jih je mogoče vstaviti v črpalko, ne da bi jih pred tem preluknjali.
Insert the needle into your skin and finish your injection.
Iglo zabodite v kožo in končajte injiciranje.
C. Illness
C. Bolezen
• eating a lot more than your diet allows; or • fever, infection or emotional stress.
•pojedli ste veliko več, kot predpisuje vaša dieta; ali •imate zvišano telesno temperaturo, okužbo ali čustvene obremenitve.
Each vial contains 1000 units (10 millilitres).
Vsaka viala vsebuje 1000 enot (10 mililitrov).
• taking less insulin than your doctor tells you to;
•vzeli ste manj insulina, kot vam je predpisal zdravnik;
If the therapeutic regimen requires the injection of basal insulin and Liprolog at the same time, the two can be mixed in the syringe.
Če režim zdravljenja zahteva sočasno injiciranje bazalnega insulina in zdravila Liprolog, ju lahko zmešate v injekcijski brizgi.
Before removing the needle from the vial, check the syringe for air bubbles that reduce the amount of Liprolog in it.
Preden izvlečete iglo iz viale, preverite, ali so v injekcijski brizgi zračni mehurčki, ki zmanjšajo količino zdravila Liprolog v njej.
After injection, the site of injection should not be massaged.
Po injiciranju mesta injiciranja ne smemo masirati.
Patients must visually verify the dialled units on the dose counter of the pen.
Bolniki morajo s pregledom preveriti število nastavljenih enot na števcu odmerkov peresnika.
For example if you do need to inject a mixture, draw the Liprolog into the syringe before the long acting insulin.
Na primer, če si morate injicirati mešanico, potegnite zdravilo Liprolog v injekcijsko brizgo pred insulinom z dolgotrajnim delovanjem.
empagliflozin, DPP-4-inhibitors like sitagliptin or saxagliptine, ),
empagliflozin, inhibitorji DPP-4, kot je sitagliptin ali saksagliptin);
Patients who fail to respond to glucagon must be given glucose solution intravenously.
Bolnikom, ki se ne odzovejo na glukagon, je treba dati intravensko raztopino glukoze.
Hyperglycaemia can lead to diabetic ketoacidosis.
Hiperglikemija lahko vodi v diabetično ketoacidozo.
• Dose Knob: Blue, with raised ridges on end and side
• Gumb za odmerjanje: moder, z dvignjenimi robovi na koncu in ob straneh
The time difference between countries may mean that you have to have your injections and meals at different times from when you are at home.
Zaradi časovne razlike med državami boste mogoče morali na potovanjih jesti obroke in si injicirati insulin ob drugih urah dneva, kakor če bi bili doma.
If bubbles are present, hold the syringe straight up and tap its side until the bubbles float to the top.
Če so mehurčki prisotni, držite injekcijsko brizgo navpično navzgor in trkajte po njej, dokler ne izplavite mehurčkov na vrh.
When filling the pump reservoir avoid damaging it by using the correct needle length on the filling system.
Ob polnjenju vsebnika črpalke pazite, da ga ne poškodujete; uporabite ustrezno dolžino igle za sistem polnjenja.
Liprolog is also indicated for the initial stabilisation of diabetes mellitus.
Zdravilo Liprolog je indicirano tudi za začetno stabilizacijo diabetesa.
• Check the name, type and strength of insulin dispensed
• Preverite ime, vrsto in jakost izdanega insulina.
The DHPC and patient communication are aimed at increasing awareness about the fact that Liprolog is now available in two strengths and describing key differences in the design of the packages and the pre-filled pen devices to minimise the risk of medication errors and mix up between the two different strengths of Liprolog.
Namen neposrednega obvestila zdravstvenim delavcem (DHPC) in informacij za bolnike je izboljšanje informiranosti o dejstvu, da je zdravilo Liprolog zdaj na voljo v dveh jakostih in opis ključnih razlik v zasnovi pakiranj in napolnjenih peresnikov za zmanjšanje tveganj za napake pri zdravljenju in nenamerno zamenjavo dveh različnih jakosti zdravila Liprolog.
Not Insulin-Naive Patients n = 97
Bolniki, ki so že bili na zdravljenju z insulinom n = 97
This rapid onset of activity allows a Liprolog injection (or, in the case of administration by continuous subcutaneous infusion, a Liprolog bolus) to be given very close to mealtime.
Ta hitri začetek delovanja omogoča, da si je injekcijo zdravila Liprolog (ali bolus zdravila Liprolog v primeru dajanja z neprekinjeno subkutano infuzijo) mogoče dati časovno zelo blizu obroka.
If an interruption to insulin flow is suspected, follow the instructions in the product literature and if appropriate, notify your doctor or clinic.
Če sumite, da je prišlo do prekinitve pretoka insulina, se ravnajte po navodilih za uporabo izdelka in po potrebi o tem obvestite zdravnika ali osebje diabetološke ambulante.
Hyperglycaemia (too much sugar in the blood) means that your body does not have enough insulin.
Hiperglikemija (previsok krvni sladkor) pomeni, da vaše telo nima dovolj insulina.
This information does not take the place of talking to your healthcare professional about your medical condition or your treatment.
Te informacije pa ne morejo nadomestiti pogovora z vašim zdravnikom o vaši bolezni ali vašem zdravljenju.
If you get worse and your breathing is shallow and your skin gets pale, tell your doctor at once.
Če se vam počutje poslabša in postane dihanje plitvo in koža bleda, pa nemudoma pokličite zdravnika.
• Reporting of medication errors or any side effects
• Poročanje o napakah pri zdravljenju in vseh neželenih učinkih.
Acute, one month and twelve month toxicology studies produced no significant toxicity findings.
toksičnosti po enem mesecu uporabe in toksičnosti po dvanajstih mesecih uporabe niso pokazale pomembne toksičnosti.
The dose knob is blue with raised ridges.
Gumb za odmerjanje je moder, z dvignjenimi robovi.
Insulin requirements may be reduced in patients with hepatic impairment due to reduced capacity for gluconeogenesis and reduced insulin breakdown; however, in patients with chronic hepatic impairment, an increase in insulin resistance may lead to increased insulin requirements.
Pri bolnikih z okvarjenim delovanjem jeter so lahko potrebe po insulinu zmanjšane zaradi zmanjšane zmožnosti glukoneogeneze in zmanjšane razgradnje insulina; vendar pa lahko pri bolnikih s kronično okvaro jeter povečanje odpornosti na insulin povzroči povečane potrebe po insulinu.
Red
Rdeč
Eli Lilly and Company, Lilly Technology Center Building 130, Indianapolis, Indiana, USA Lilly del Caribe, Inc., Puerto Rico Industrial Park, 12.3 KM (PR05), 65th Infantry Road, Carolina, Puerto Rico 00985
Eli Lilly and Company, Lilly Technology Center Building 130, Indianapolis, Indiana, ZDA Lilly del Caribe, Inc., Puerto Rico Industrial Park, 12.3 KM (PR05), 65th Infantry Road, Carolina, Portoriko 00985
If repeated or severe low blood glucose levels occur, consider the need to reduce or stop an insulin infusion.
Če imate pogoste ali hude epizode nizke ravni glukoze v krvi, premislite, ali bi bilo morda treba zmanjšati ali prenehati z infuzijo insulina.
This usually clears up in anything from a few days to a few weeks.
To običajno mine v nekaj dneh do nekaj tednih.
Overdose can result causing severe hypoglycemia.
Lahko pride do prevelikega odmerjanja, ki povzroči hudo hipoglikemijo.
While you are not confident about recognising your warning symptoms, avoid situations such as driving a car, in which you or others would be put at risk by hypoglycaemia.
Če niste prepričani, da boste zagotovo prepoznali opozorilne simptome, se izogibajte okoliščinam, kot je vožnja avtomobila, v katerih bi zaradi hipoglikemije ogrozili sebe ali druge.
In a double-blind, crossover study, the reduction in glycosylated haemoglobin levels after 12 weeks dosing was 0.37 percentage points with insulin lispro, compared to 0.03 percentage points for soluble insulin (p = 0.004).
V dvojno slepi navzkrižni študiji so po 12 tednih odmerjanja insulina lispro dosegli 0,37 % zmanjšanje ravni glikiranega hemoglobina v primerjavi z 0,03 % pri topnem insulinu (p = 0,004).
- The dose can be corrected by turning the Dose Knob in either direction until the correct dose lines up with the Dose Indicator.
- Odmerek je mogoče popraviti z obračanjem gumba za odmerjanje v obe smeri, dokler se pravi odmerek ne poravna s kazalnikom odmerka.
Fertility Insulin lispro did not induce fertility impairment in animal studies (see section 5.3).
V študijah na živalih insulin lispro ni povzročil zmanjšane plodnosti (glejte poglavje 5.3).