natgillin/translations-raw huggingface dataset:
Taxotere can only be obtained with a prescription and should only be used in units specialising in giving chemotherapy (medicines to treat cancer) under the supervision of a doctor who is qualified in the use of chemotherapy. 
Predpisovanje in izdaja zdravila Taxotere je le na recept, uporabljati pa se sme samo v enotah, specializiranih za kemoterapijo (zdravila za zdravljenje raka), pod nadzorom zdravnika, ki ima izkušnje z uporabo tovrstnega zdravljenja.
It can also be used with cisplatin (another cancer medicine) in patients who have not received any treatment for their cancer; 
Uporablja se lahko tudi v kombinaciji s cisplatinom (drugim zdravilom za zdravljenje raka) pri bolnikih, ki se zaradi raka še niso zdravili;
How is Taxotere used? 
Kako se zdravilo Taxotere uporablja?
How does Taxotere work? 
Kako zdravilo Taxotere deluje?
For the full list of side effects of Taxotere, see the package leaflet. 
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Taxotere, glejte navodilo za uporabo.
Taxotere contains the active substance docetaxel. 
Zdravilo Taxotere vsebuje učinkovino docetaksel.
90 (3x30) tablets (multipack) 
90 (3x30) tablet (večkratno pakiranje)
MA (EU) number (Invented) name Strength Pharmaceutical Form Route of Administration Immediate Packaging Pack size EU/1/15/1068/001 Wakix 
Jakost Farmacevtska oblika Pot uporabe
Radiopharmaceutical precursor, solution vial (glass) 1 to 3 ml 
Radiofarmacevtski predhodnik, raztopina viala (steklena)
They will tell you what needs to be done. 
On vam bo povedal, kaj je potrebno storiti.
TIME - hour 
ČAS - ure
These reactions are usually transitory and normally they disappear during continued treatment. 
Te reakcije so ponavadi prehodne in med nadaljnjim zdravljenjem običajno izginejo.
THE FOLLOWING INFORMATION IS INTENDED FOR HEALTHCARE PROFESSIONALS ONLY: 
NASLEDNJE INFORMACIJE SO NAMENJENE SAMO ZDRAVSTVENEMU OSEBJU:
Most minor reactions to insulins usually resolve in a few days to a few weeks. 
Večina manjših reakcij na insuline običajno mine v nekaj dneh do nekaj tednih.
If this happens you must seek urgent medical help. 
Če se vam to zgodi, morate nujno poiskati zdravniško pomoč.
The potency of this preparation is stated in units. 
Jakost tega preparata je navedena v enotah.
Clinical efficacy and safety 
Klinična varnost in učinkovitost
ATC code: A10AB06 
Oznaka ATC: A10AB06
This should be carried out by healthcare professionals. 
Takšno dajanje mora opraviti zdravstveno osebje.
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 27 September 2004 
DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Z ZDRAVILOM Datum prve odobritve: 27. september 2004 Datum zadnjega podaljšanja: 20. avgust 2009
Studies on pharmacokinetic interactions have not been performed. 
Študije farmakokinetičnih interakcij niso bile izvedene.
The average body mass index (BMI) of patients was 34.55 kg/m2. 
Povprečni indeks telesne mase (ITM) bolnikov je bil 34,55 kg/m2.
The use of other solutions has not been studied. 
Uporaba drugih raztopin ni raziskana.
Based on empirical knowledge from similar medicinal products, clinically relevant pharmacokinetic interactions are unlikely to occur. 
Na podlagi empiričnega znanja o podobnih zdravilih klinično pomembne farmakokinetične interakcije niso verjetne.
The marketing authorisation holder shall submit periodic safety update reports for this product in accordance with the requirements set out in the list of Union reference dates (EURD list) ) provided for under Article 107c(7) of Directive 2001/83/EC and published on the European medicines web-portal. 
Imetnik dovoljenja za promet z zdravilom mora prvo redno posodobljeno poročilo o varnosti zdravila za to zdravilo predložiti v skladu z zahtevami, določenimi v seznamu referenčnih datumov Unije (seznamu EURD), opredeljenem v členu 107c(7) Direktive 2001/83/ES in objavljenem na evropskem spletnem portalu o zdravilih.
Caution should be exercised when prescribing to pregnant women. 
Pri predpisovanju nosečnicam je potrebna previdnost.
Failure to follow these specific instructions may lead to serious adverse events. 
Neupoštevanje teh specifičnih navodil lahko povzroči resne neželene učinke.
The frequency of hyperglycaemia cannot be estimated. 
Pogostnosti hiperglikemije ni mogoče oceniti.
Adjustment of dose may be also necessary if patients undertake increased physical activity or change their usual meal plan. 
Prilagoditev odmerka utegne biti potrebna tudi, če je bolnik telesno bolj dejaven ali spremeni običajni razpored obrokov.
After an injection of glucagon, the patient should be monitored in a hospital in order to find the reason for this severe hypoglycaemia and prevent other similar episodes. 
Po injekciji glukagona je bolnika treba nadzorovati v bolnišnici, da bi ugotovili razlog takšne hude hipoglikemije in bi preprečili podobne ponovitve.
Carry some information with you to show you are a person with diabetes. 
Pri sebi imejte tudi nekaj, iz česar bo razvidno, da ste oseba, ki ima sladkorno bolezen.
It has a dark blue injection button with a raised ring on the top. 
Ima temno moder gumb za injiciranje z dvignjenim prstanom na vrhu injekcijskega peresnika.
Since Apidra is a solution, it does not require resuspension before use. 
Ker je Apidra raztopina, pred uporabo ne potrebuje resuspendiranja.
Careful control of your diabetes, and prevention of hypoglycaemia, is important for the health of your baby. 
Natančen nadzor nad vašo sladkorno boleznijo in preprečevanje hipoglikemij sta pomembna za zdravje vašega otroka.
Your doctor will show you in which area of the skin you should inject Apidra. 
Zdravnik vam bo pokazal, v kateri predel kože injicirajte zdravilo Apidra.
Use the pump system recommended by your doctor. 
Uporabite sistem s črpalko, ki ga svetuje zdravnik.
The following related adverse reactions from clinical studies were listed below by system organ class and in order of decreasing incidence (very common: ≥1/10; common: ≥1/100 to <1/10; uncommon: ≥1/1,000 to <1/100; rare: ≥1/10,000 to <1/1,000; very rare: <1/10,000), not known (cannot be estimated from the available data). 
Naslednji povezani neželeni učinki, ugotovljeni v kliničnih študijah, so navedeni spodaj po organskem sistemu in razvrščeni po padajoči incidenci (zelo pogosti: ≥ 1/10; pogosti: ≥ 1/100 do < 1/10; občasni: ≥ 1/1.000 do < 1/100; redki: ≥ 1/10.000 do < 1/1.000; zelo redki: < 1/10.000), neznana (ni mogoče oceniti iz razpoložljivih podatkov).
Glucose must also be given intravenously, if the patient does not respond to glucagon within 10 to 15 minutes. 
Intravensko glukozo je treba uporabiti tudi v primeru, če se bolnik v 10 do 15 minutah ne odzove na glukagon.
This may constitute a risk in situations where these abilities are of special importance (e.g. driving a car or operating machines). 
To je lahko nevarno v okoliščinah, v katerih sta ti zmožnosti posebno pomembni (npr. pri vožnji avtomobila ali upravljanju s stroji).
Symptoms of hypoglycaemia usually occur suddenly. 
Simptomi hipoglikemije se ponavadi pojavijo nenadoma.
SoloStar has to be protected from dust and dirt. 
SoloStar morate zaščititi pred prahom in umazanijo.
Injection should be given immediately after mixing. 
Injicirati morate takoj po mešanju.
Follow closely the instructions for dose, monitoring (blood tests), diet and physical activity (physical work and exercise) as discussed with your doctor. 
Natančno upoštevajte navodila za odmerjanje, nadziranje bolezni (testi krvi), prehrano in telesno dejavnost (telesno delo in telovadbo), ki vam jih je dal zdravnik.
Important information about some of the ingredients of Apidra 
Pomembne informacije o nekaterih sestavinah zdravila Apidra
The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the Marketing Authorisation and any agreed subsequent updates of the RMP. 
Imetnik dovoljenja za promet z zdravilom bo izvedel zahtevane farmakovigilančne aktivnosti in ukrepe, podrobno opisane v sprejetem v RMP, predloženem v modulu 1.8.2 dovoljenja za promet z zdravilom, in vseh nadaljnih posodobitvah RMP.
If you have symptoms of low blood sugar, take actions to increase your blood sugar level immediately. 
Če imate simptome nizkega krvnega sladkorja, takoj ukrepajte, da si dvignete koncentracijo krvnega sladkorja.
It is essential for patients with pre-existing or gestational diabetes to maintain good metabolic control throughout pregnancy. 
Nujno je, da bolnice z obstoječim ali gestacijskim diabetesom vso nosečnost vzdržujejo dobro urejenost presnove.
It is therefore recommended that the diabetic patient constantly carries some sugar lumps, sweets, biscuits or sugary fruit juice. 
Zato je priporočljivo, da ima diabetični bolnik vedno pri sebi nekaj kock sladkorja, bonbone, piškote ali sadni sok, ki vsebuje sladkor.
Exercise taken immediately after a meal may increase the risk of hypoglycaemia. 
Telesna dejavnost takoj po obroku lahko zveča tveganje za hipoglikemijo.
You should know these factors so that you are able to react correctly to changes in your blood sugar level and to prevent it from becoming too high or too low. 
Poznati jih morate, da se boste lahko pravilno odzvali na spremembe v koncentraciji krvnega sladkorja in preprečili, da bi se preveč zvišala ali znižala.
INSTRUCTIONS ON USE Open here 
NAVODILA ZA UPORABO Odprite tukaj
GLULISINE - pre REGULAR - 30 min 
GLULISIN - pred NAVADNI - 30 min
These instructions may differ from general pump manual instructions. 
Ta navodila se lahko razlikujejo od splošnih navodil v priročniku za črpalko.
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). 
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).
Most of the cases were related to handling errors or pump system failure. 
Večina teh primerov je bila povezana z napakami pri ravnanju ali z odpovedjo sistema s črpalko.
Transferring a patient to another type or brand of insulin should be done under strict medical supervision. 
Prehod na drugo vrsto ali znamko insulina je treba opraviti pod strogim zdravniškim nadzorom.
This means you may not always get enough insulin to treat your diabetes. 
To lahko pomeni, da ne dobite dovolj insulina za zdravljenje sladkorne bolezni.
Pharmacotherapeutic group: Drugs used in diabetes, insulins and analogues for injection, fast-acting. 
Farmakoterapevtska skupina: Zdravila za zdravljenje diabetesa, insulini in analogi za injiciranje s hitrim delovanjem.
Figure 1: Average glucose-lowering effect over 6 hours in 20 patients with type 1 diabetes mellitus. 
Slika 1: Povprečni učinek na znižanje glukoze v 6 urah pri 20 bolnikih z diabetesom mellitusom tipa 1.
Absorption from deltoid sites was in-between (see section 4.2). 
Absorpcija z mest v deltoidnem predelu je bila vmes (glejte poglavje 4.2).
Injection should be given immediately after mixing as no data are available regarding the mixtures made up a significant time before injection. 
Injekcijo je treba dati takoj po mešanju, kajti podatkov o mešanicah, pripravljenih precej pred injiciranjem, ni.
This should be kept in mind if treatment with the combination of pioglitazone and Apidra is considered. 
To je potrebno upoštevati pri zdravljenju s kombinacijo pioglitazona in zdravila Apidra.
Concomitant oral antidiabetic treatment may need to be adjusted. 
Potrebna utegne biti prilagoditev sočasnega peroralnega antidiabetičnega zdravljenja.
- If you are allergic to insulin glulisine or any of the other ingredients of this medicine (listed in section 6). 
• Če ste alergični na insulin glulisin ali katero koli sestavino tega zdravila (navedeno v poglavju
- Do not take a double dose to make up for a forgotten dose. 
Ne vzemite dvojnega odmerka, če ste pozabili vzeti prejšnji odmerek.
The Apidra SoloStar is blue. 
Apidra SoloStar je modre barve.
Treatment of adults, adolescents and children 6 years or older, with diabetes mellitus, where treatment with insulin is required. 
Zdravljenje odraslih, mladostnikov in otrok, starih 6 let ali več, ki imajo diabetes mellitus in potrebujejo zdravljenje z insulinom.
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. 
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.
There is insufficient clinical information on the use of Apidra in children younger than the age of 6 years. 
Ni zadostnih kliničnih podatkov o uporabi zdravila Apidra pri otrocih mlajših od 6 let.
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”). 
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").
• 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. 
• Če vam injekcijo daje druga oseba, ali če vi dajete injekcijo drugi osebi, je potrebna posebna previdnost pri odstranjevanju in odlaganju igle.
Your doctor has decided that SoloStar is appropriate for you based on your ability to handle SoloStar. 
Vaš zdravnik je presodil, da je SoloStar primeren za vas.
• 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).