natgillin/translations-raw huggingface dataset:
It works more quickly than normal human insulin because the insulin molecule has been changed slightly.
Deluje hitreje kakor običajni humani insulin, ker je molekula insulina v njem nekoliko spremenjena.
Three simple steps to avoid hypoglycaemia or hyperglycaemia are:
Trije preprosti koraki za preprečevanje hipoglikemije ali hiperglikemije so:
Wipe the top of the vial with an alcohol swab.
Vrh viale obrišite z alkoholnim lističem.
• using less insulin than your doctor tells you to;
• uporabili ste manj insulina, kot vam je predpisal zdravnik,
Store below 30°C and protect from direct heat and light.
Shranjujte pri temperaturi do 30°C in zaščiteno pred neposredno toploto ali svetlobo.
In some studies, reduction of nocturnal hypoglycaemia was associated with increased episodes of daytime hypoglycaemia.
V nekaterih študijah je bilo zmanjšanje števila nočnih hipoglikemij povezano z večjim številom dnevnih hipoglikemij.
• blood pressure dropping
• padec krvnega tlaka
After injection, the site of injection should not be massaged.
Po injiciranju se mesta injiciranja ne sme masirati.
Choose a site for injection.
Izberite mesto za injiciranje.
The reduction of HbA1c would also be expected with other insulin products e.g. soluble or isophane insulins.
Znižanje HbA1c bi pričakovali tudi pri drugih insulinih, npr. pri topnem ali izofanem insulinu.
This can be caused if:
To se lahko pojavi:
Patients with diabetes should be advised to inform their doctor if they are pregnant or are contemplating pregnancy.
Bolnicam s sladkorno boleznijo je treba svetovati, naj obvestijo svojega zdravnika, če zanosijo ali načrtujejo zanositev.
The typical activity profile following subcutaneous injection is illustrated below.
Značilni profil delovanja po subkutanem injiciranju je prikazan spodaj.
Illness
Bolezen
Inform your doctor as soon as possible, if you experience signs of heart failure such as unusual shortness of breath or rapid increase in weight or localised swelling (oedema).
Čim prej obvestite svojega zdravnika, če se vam pojavijo znaki srčnega popuščanja, npr. nenavadno kratka sapa, hitro povečanje telesne teže ali lokalizirano otekanje (edem).
A Choose a place to inject as shown in the picture
A Izberite mesto za injiciranje, kot prikazuje slika.
Severe hypoglycaemia may lead to loss of consciousness, and in extreme cases, death.
Huda hipoglikemija lahko povzroči izgubo zavesti, v skrajnih primerih celo v smrt.
If you often have hypoglycaemia or have difficulty recognising it, please discuss this with your doctor.
Če imate hipoglikemije pogosto, ali če jih težko prepoznate, se morate o tem posvetovati z zdravnikom.
Press the knob.
Pritisnite na gumb.
• 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 boste zmanjšali tveganje za naključno poškodbo z iglo in prenos nalezljivih bolezni.
Patients who are blind or have poor vision must be instructed to always get help/assistance from another person who has good vision and is trained in using the insulin device.
Slepim ali slabovidnim bolnikom je treba naročiti, naj vedno poskrbijo za pomoč druge osebe, ki dobro vidi in je usposobljena za uporabo pripomočka za insulin.
Systemic allergy
Sistemska alergija
• If you cannot select your full prescribed dose, use a new pen or inject the remaining units and use a new pen to complete your dose.
• Če ne morete nastaviti celotnega predpisanega odmerka, uporabite nov peresnik ali injicirajte preostanek enot, nato pa za dokončanje odmerka uporabite nov peresnik.
For the treatment of adults and children with diabetes mellitus who require insulin for the maintenance of normal glucose homeostasis.
Zdravljenje odraslih in otrok s sladkorno boleznijo, ki potrebujejo insulin za vzdrževanje normalne homeostaze glukoze.
Please get rid of it carefully - your pharmacist or diabetes nurse will tell you how to do this.
Zavrzite ga ustrezno - farmacevt ali diabetološka medicinska sestra vam bosta povedala, kako to storiti.
Here are some reminders.
Tukaj je nekaj pomembnih opozoril.
• a puncture resistant container for used needles and pens (see Throwing your pen away).
• vsebnik za ostre odpadke za uporabljene igle in peresnike (glejte Kako zavreči peresnik).
You should only inject it into a muscle if your doctor has told you to.
V mišico ga smete injicirati le, če vam tako naroči zdravnik.
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, piskajoče dihanje, znižanje krvnega tlaka, hiter srčni utrip ali znojenje.
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).
Teh vložkov se ne sme uporabljati z nobenim drugim injekcijskim peresnikom za večkratno uporabo, ker je točnost odmerjanja ugotovljena le z navedenimi peresniki (glejte poglavji 4.2 in 6.6).
This may damage your pen.
S tem namreč lahko poškodujete peresnik.
C Place your thumb on the injection button.
C Položite palec na gumb za injiciranje.
This is normal, they will not harm you.
To je normalno in neškodljivo.
- if you are allergic to insulin lispro or to any of the other ingredients of this medicine (listed in section 6).
- če ste alergični na insulin lispro ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
• If there are not enough units left in your pen for your dose, the dose selector will stop at the number of units left.
• Če v peresniku ni več dovolj enot insulina za vaš odmerek, se bo izbirnik odmerka ustavil na številu enot, ki so preostale.
• You should also tell your doctor, pharmacist or diabetes nurse if you are planning to go abroad.
• Zdravnika, farmacevta ali diabetološko medicinsko sestro obvestite tudi, če načrtujete potovanje v tujino.
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 isto mesto ni uporabljeno več kot približno enkrat na mesec.
Never share your pen - it is only for you.
Svojega peresnika nikdar ne uporabljajte skupaj s kom drugim - namenjen je le za vašo uporabo.
• Use a clean needle.
• Uporabite čisto iglo.
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 vam lahko potreba po insulinu spremeni.
If you have any questions about your pen or about diabetes, ask your doctor, pharmacist or nurse or call sanofi-aventis number on the front of this leaflet.
Če imate vprašanja o peresniku ali o sladkorni bolezni, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro, ali pokličite številko družbe sanofi-aventis, ki je napisana na sprednji strani tega navodila.
• Make sure you have the correct insulin.
• Preverite, da imate pravi insulin.
If the combination is used, patients should be observed for signs and symptoms of heart failure, weight gain and oedema.
Če je uporabljena ta kombinacija, je treba bolnike spremljati glede znakov in simptomov srčnega popuščanja, povečevanja telesne mase in edemov.
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 morda morali na potovanjih jesti obroke in si injicirati insulin ob drugem času kot doma.
• “beta2 stimulants” (for example ritodrine, salbutamol or terbutaline),
• “stimulatorje receptorjev beta2” (na primer ritodrin, salbutamol ali terbutalin),
• some angiotensin converting enzyme (ACE) inhibitors (for example captopril, enalapril), and
• nekatere zaviralce angiotenzinske konvertaze (ACE) (na primer kaptopril, enalapril) ali
Use a new pen.
Uporabite nov peresnik.
Changes in strength, brand (manufacturer), type (regular, NPH, lente, 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.
V primeru spremembe jakosti, blagovne znamke (izdelovalca), tipa (navadni, NPH, lente itn.), vrste (živalski, humani, analog humanega insulina) in/ali načina izdelave (z rekombinantno DNA ali z insulinom živalskega izvora) je lahko potrebna sprememba odmerjanja insulina.
• If you still find it hard to press in, get a new pen.
• Če gumb še vedno težko pritisnete noter, vzemite nov peresnik.
If bubbles are present, hold the syringe straight up and tap its side until the bubbles float to the top.
Če so prisotni mehurčki, držite injekcijsko brizgo navpično navzgor in trkajte po njej, dokler mehurčki ne splavajo na vrh.
The number of units are displayed in the dose window, always check this before your injection.
Število enot je prikazano v odmernem okencu; pred injiciranjem morate to število vedno preveriti.
A Make sure a needle is attached and the dose is set to ‘0'.
A Preverite, da je igla nameščena in da je odmerek nastavljen na "0".
It should be clear and colourless.
Biti mora bistra in brezbarvna.
This condition usually resolves in a few days to a few weeks.
Takšno stanje po navadi mine v nekaj dneh do nekaj tednih.
If you get worse and your breathing is shallow and your skin gets pale, tell your doctor at once.
Če se vam stanje poslabša in postane dihanje plitvo in koža bleda, nemudoma pokličite zdravnika.
Mixing of the insulins ahead of time or just before the injection should be on advice of the physician.
Mešanje insulinov vnaprej ali tik pred injiciranjem je treba opraviti po zdravnikovem navodilu.
For both, the needed dose is dialled in units.
Pri obeh se potrebni odmerek nastavi v enotah.
If your blood sugar is low (mild hypoglycaemia), eat glucose tablets, sugar or drink a sugary drink.
Če imate nizek krvni sladkor (blago hipoglikemijo), zaužijte nekaj tablet glukoze, nekaj sladkorja ali popijte sladko pijačo.
Protect your pen from dust and dirt
Zaščitite peresnik pred prahom in umazanijo.
• no appetite
• pomanjkanje apetita
B Push the needle into your skin as shown by your doctor, pharmacist or nurse.
B Zabodite iglo v kožo, kot vam je pokazal zdravnik, farmacevt ali medicinska sestra.
• If no insulin comes out after the third time, the needle may be blocked.
• Če tudi tretjič ne priteče nič insulina, je igla morda zamašena.
The symptoms include the following:
Med simptomi so:
Data on a large number of exposed pregnancies do not indicate any adverse effect of insulin lispro on pregnancy or on the health of the foetus/new-born.
Podatki o velikem številu izpostavljenih nosečnosti ne kažejo neželenih učinkov insulina lispro na nosečnost ali zdravje ploda ali novorojenčka.
If using a new vial, flip off the plastic protective cap, but do not remove the stopper.
Če uporabljate novo vialo, snemite plastični zaščitni pokrovček, ne odstranite pa zamaška.
• Do not touch the injection button yet
• Ne dotikajte se še gumba za injiciranje.
Learn to inject
Naučite se injicirati
Insulin requirements usually fall during the first trimester and increase during the second and third trimesters.
Potreba po insulinu se po navadi zmanjša v prvem trimesečju nosečnosti in se poveča v drugem in tretjem trimesečju.
The symptoms are as follows:
Simptomi so:
It is not for use in 1.5 ml pens.
Ni namenjen uporabi v 1,5-ml injekcijskih peresnikih.
Use the correct reservoir and catheter for the pump.
Uporabite ustrezen rezervoar in kateter za črpalko.
Uncorrected hypoglycaemic or hyperglycaemic reactions can cause loss of consciousness, coma, or death.
Nekorigirane hipoglikemije ali hiperglikemije lahko povzročijo izgubo zavesti, komo ali smrt.
Transferring a patient to another type or brand of insulin Transferring a patient to another type or brand of insulin should be done under strict medical supervision.
Prehod bolnika na drugo vrsto ali blagovno znamko insulina Prehod bolnika na drugo vrsto ali blagovno znamko insulina mora potekati pod strogim zdravniškim nadzorom.
After injecting
Po injiciranju
In some instances, this condition may be related to factors other than insulin, such as irritants in the skin cleansing agent or poor injection technique.
V nekaterih primerih je to stanje lahko povezano z drugimi dejavniki in ne z insulinom samim, na primer z dražečimi snovmi v sredstvih za čiščenje kože ali s slabo tehniko injiciranja.
Acute, one month and twelve month toxicology studies produced no significant toxicity findings.
Študije akutne toksičnosti, toksičnosti po enem mesecu uporabe in toksičnosti po dvanajstih mesecih uporabe niso pokazale pomembne toksičnosti.
Hypoglycaemia may occur as a result of an excess of insulin activity relative to food intake and energy expenditure.
Hipoglikemija se lahko pojavi zaradi prekomernega delovanja insulina glede na vnos hrane in porabo energije.
Insulin lispro has a rapid onset of action (approximately 15 minutes), thus allowing it to be given closer to a meal (within zero to 15 minutes of the meal) when compared to regular insulin (30 to 45 minutes before).
Insulin lispro začne delovati hitro (po približno 15 minutah), zato ga je mogoče injicirati bliže obroku (0 do 15 minut pred obrokom) kot navadni insulin (od 30 do 45 minut pred obrokom).
Local allergy is common (may affect up to 1 in 10 people).
Lokalna alergija je pogosta (pojavi se lahko pri do 1 od 10 oseb).
A Check the name and expiration date on the label of your pen.
A Preverite ime in datum izteka uporabnosti na nalepki peresnika.
• Ask for help if you have problems handling the pen, for example if you have problems with your sight.
• Če imate pri ravnanju s peresnikom težave (na primer če imate težave z vidom), prosite za pomoč.
Special populations Renal impairment
Posebne populacije bolnikov Okvara ledvic
Lipodystrophy (thickening or pitting of the skin) is uncommon (may affect up to 1 in 100 people).
Lipodistrofija (zadebelitev ali vdolbina v koži) je občasen neželen učinek (pojavi se lahko pri do 1 od 100 oseb).
It is recommended that the system is primed before starting the infusion to the patient.
Sistem je pred začetkom infundiranja bolniku priporočljivo pripraviti za uporabo.
Systemic allergy is rare (may affect up to 1 in 1,000 people).
Sistemska alergija je redka (pojavi se lahko pri do 1 od 1.000 oseb).
• difficulty in breathing
• težko dihanje
• nervousness or shakiness
• živčnost ali tresavica
This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e., essentially “sodium-free”.
To zdravilo vsebuje manj kot 1 mmol (23 mg) natrija na odmerek; to pomeni, da je praktično "brez natrija".
Patients must visually verify the dialled units on the dose counter of the pen.
Bolniki morajo s pregledom preveriti nastavljeno število enot na števcu odmerkov peresnika.
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 insuline ni specifične opredelitve prevelikega odmerjanja, ker je koncentracija glukoze v serumu posledica zapletenih medsebojnih delovanj med ravnjo insulina, razpoložljivostjo glukoze in drugimi presnovnimi procesi.
• Never use your pen after the expiration date.
• Peresnika nikoli ne uporabljajte po datumu izteka roka uporabnosti.
If the patient is comatose, glucagon should be administered intramuscularly or subcutaneously.
Če je bolnik komatozen, je treba glukagon dati intramuskularno ali subkutano.
Sustained carbohydrate intake and observation may be necessary because hypoglycaemia may recur after apparent clinical recovery.
Potrebno je lahko dolgotrajnejše uživanje ogljikovih hidratov in opazovanje, kajti hipoglikemija se lahko po navideznem kliničnem izboljšanju ponovi.
B Turn the dose selector until the dose pointer lines up with your dose.
B Zavrtite izbirnik odmerka, dokler kazalnik odmerka ni nastavljen na vaš odmerek.
If hypoglycaemia (low blood sugar) or hyperglycaemia (high blood sugar) is not treated, they can be very serious and cause headaches, feeling sick (nausea), being sick (vomiting), loss of fluids (dehydration), unconsciousness, coma or even death (see Hypoglycaemia and Hyperglycaemia and diabetic ketoacidosis in section 4 “Possible Side Effects”).
Nezdravljena hipoglikemija (nizek krvni sladkor) ali hiperglikemija (visok krvni sladkor) je lahko zelo resna: povzroči lahko glavobol, slabost (siljenje na bruhanje), izgubo tekočine (dehidracijo), nezavest, komo ali celo smrt (glejte Hipoglikemija ter Hiperglikemija in diabetična ketoacidoza v poglavju 4, "Možni neželeni učinki").
Your doctor or clinic will tell you how to do this.
Zdravnik ali osebje v diabetološki ambulanti vam bodo povedali, kako to narediti.
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 se je po 12 tednih uporabe glikirani hemoglobin znižal za 0,37 odstotne točke z insulinom lispro in za 0,03 odstotne točke z navadnim insulinom (p =
Hypoglycaemia (low blood sugar) means there is not enough sugar in the blood.
Hipoglikemija (nizek krvni sladkor) pomeni, da v krvi ni dovolj sladkorja.
Intravenous injection of insulin lispro should be carried out following normal clinical practice for intravenous injections, for example by an intravenous bolus or by an infusion system.
Intravensko injiciranje insulina lispro je treba izvajati v skladu z običajno klinično prakso za intravensko injiciranje, na primer z intravenskim bolusom ali z infuzijskim sistemom.
STEP 4: Select the dose
KORAK: Izberite odmerek
STEP 1: Check your pen
KORAK: Preverite vaš peresnik
Please keep this possible problem in mind in all situations where you might put yourself and others at risk (e.g. driving a car or using machines).
To možno težavo morate imeti v mislih v vseh okoliščinah, v katerih bi lahko ogrozili svojo varnost ali varnost drugih (npr. pri vožnji avtomobila ali uporabi strojev).
• some antidepressants (monoamine oxidase inhibitors or selective serotonin reuptake inhibitors),
• nekatere antidepresive (zaviralce monoaminooksidaze ali selektivne zaviralce prevzema serotonina),
Preparing a dose
Priprava odmerka
Units of insulin in your pen
Enote insulina v vašem peresniku
C Check that the insulin is clear.
C Preverite, da je insulin bister.
How to read the dose window Even numbers are shown in line with the dose pointer:
Kako odčitati okence odmerka Soda števila so prikazana uravnana s kazalnikom odmerka:
A Select 2 units by turning the dose selector until the dose pointer is at the 2 mark.
A Izberite 2 enoti tako, da zavrtite izbirnik odmerka, dokler kazalnik odmerka ne kaže oznake
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.
Potrebe po insulinu so lahko manjše tudi pri bolnikih z okvaro jeter, ker sta zmogljivost za glukoneogenezo in razgradnjo insulina zmanjšani, a pri bolnikih s kronično okvaro jeter lahko povečanje odpornosti proti insulinu poveča potrebo po insulinu.
• a new sterile needle (see STEP 2).
• nova sterilna igla (glejte 2.
OUTER CARTON (10 ml vial)
ZUNANJA ŠKATLA (10 ml viala)
The cartridges are to be used only with the pens: Tactipen, AllStar, AllStar PRO, JuniorSTAR.
Vložke se sme uporabljati le z naslednjimi injekcijskimi peresniki: Tactipen, AllStar, AllStar PRO, JuniorSTAR.
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.
Insulin lispro je na molarni osnovi dokazano ekvipotenten humanemu insulinu, a njegov učinek je hitrejši in kratkotrajnejši.
Only use needles that are compatible for use with Insulin lispro Sanofi (e.g. needles from BD, Ypsomed, Artsana or Owen Mumford).
Uporabljajte le igle, primerne za uporabo z zdravilom Insulin lispro Sanofi (npr. igle BD, Ypsomed, Artsana ali Owen Mumford).
STEP 3: Do a safety test
KORAK: Opravite varnostni preizkus
This will often get you over mild hypoglycaemia or a minor insulin overdose.
Pogosto boste tako obvladali blago hipoglikemijo ali manjše preveliko odmerjanje insulina.
Therefore, the requirement for patients to self-inject is that they can read the dose counter on the pen.
Da si lahko bolniki zdravilo injicirajo sami, morajo biti zmožni prebrati števec odmerkov na peresniku.
You can select doses from 1 to 80 units in steps of 1 unit.
Izberete lahko odmerke od 1 do 80 enot v korakih po 1 enoto.
Clear, colourless, aqueous solution.
Bistra, brezbarvna vodna raztopina.
Hyperglycaemia can lead to diabetic ketoacidosis.
Hiperglikemija lahko povzroči diabetično ketoacidozo.
Make sure you inject at least half an inch (1 cm) from the last injection and that you ‘rotate' the places you inject, as you have been taught.
Poskrbite, da bo naslednje mesto injiciranja vsaj 1 cm oddaljeno od prejšnjega in da boste mesta injiciranja ves čas krožno menjavali, kot so vas naučili.
OTHER SoloStar
DRUGI PODATKI SoloStar
Insulin lispro Sanofi can be used in adolescents and children (see section 5.1).
Zdravilo Insulin lispro Sanofi se lahko uporablja pri mladostnikih in pri otrocih (glejte poglavje 5.1).
• Follow the instructions that come with the pen.
• Upoštevajte navodila, priložena peresniku.
• To reduce the risk of accidental needle injury, never replace the inner needle cap.
• Da boste zmanjšali tveganje za poškodbo z iglo, nikdar ne namestite nazaj notranjega pokrovčka igle.
The medicinal product should not be mixed with insulins produced by other manufacturers or with animal insulin preparations.
Tega zdravila se ne sme mešati z insulini drugih izdelovalcev ali z insulini živalskega izvora.
• Do not use your pen if there is still no insulin coming out of the needle tip.
• Ne uporabite peresnika, če iz konice igle še vedno ne pride nič insulina.
Hypoglycaemia may be associated with listlessness, confusion, palpitations, headache, sweating and vomiting.
Hipoglikemijo lahko spremljajo nemir, zmedenost, palpitacije, glavobol, znojenje in bruhanje.
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 koncentracijo v krvi 30 do 70 minut po subkutanem injiciranju.
Frequent monitoring of the blood glucose levels is required.
Pogosto je treba kontrolirati koncentracijo glukoze v krvi.
It must be clear, have no colour and no solid pieces in it.
Biti mora bistro in brezbarvno in ne sme vsebovati trdnih delcev.
Hold the vial and syringe firmly in one hand.
Vialo in injekcijsko brizgo trdno držite v eni roki.
The above representation reflects the relative amount of glucose over time required to maintain the subject's whole blood glucose concentrations near fasting levels and is an indicator of the effect of these insulins on glucose metabolism over time.
Zgornji diagram prikazuje relativno količino glukoze skozi čas, potrebno za vzdrževanje koncentracije glukoze v preiskovančevi polni krvi blizu koncentracije na tešče ter je indikator učinka obeh insulinov na presnovo glukoze skozi čas.
Hyperglycaemia and diabetic ketoacidosis
Hiperglikemija in diabetična ketoacidoza
D Keep the injection button held in and when you see "0" in the dose window, slowly count to This will make sure you get your full dose.
D Držite gumb za injiciranje pritisnjen noter; ko v okencu odmerka zagledate "0", počasi preštejte do 10.
Do not use Insulin lispro Sanofi - if you think hypoglycaemia (low blood sugar) is starting.
Ne uporabljajte zdravila Insulin lispro Sanofi - če menite, da se začenja hipoglikemija (nizek krvni sladkor).
Never select a dose or press the injection button without a needle attached.
Nikoli ne izberite odmerka in tudi ne pritisnite gumba za injiciranje, če na peresniku ni nameščena igla.