natgillin/translations-raw huggingface dataset:
Look out for the following possible signs of infection:
Bodite pozorni na naslednje znake okužbe: · zvišana telesna temperatura ali neprestano kašljanje,
Further information on Taxotere can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/taxotere.
Nadaljnje informacije za zdravilo Taxotere so na voljo na spletni strani agencije: ema.europa.eu/medicines/human/EPAR/taxotere.
The European Medicines Agency decided that Taxotere's benefits are greater than its risks and it can be authorised for use in the EU.
Evropska agencija za zdravila je zaključila, da so koristi zdravila Taxotere večje od z njim povezanih tveganj in da se lahko odobri za uporabo v EU.
What measures are being taken to ensure the safe and effective use of Taxotere?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Taxotere?
Taxotere received a marketing authorisation valid throughout the EU on 27 November 1995.
Za zdravilo Taxotere je bilo 27. novembra 1995 izdano dovoljenje za promet, veljavno po vsej EU.
Other information about Taxotere
Druge informacije o zdravilu Taxotere
As for all medicines, data on the use of Taxotere are continuously monitored.
Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Taxotere stalno spremljajo.
What benefits of Taxotere have been shown in studies?
Kakšne koristi zdravila Taxotere so se pokazale v študijah?
What is Taxotere and what is it used for?
Kaj je zdravilo Taxotere in za kaj se uporablja?
Why is Taxotere authorised in the EU?
Zakaj je bilo zdravilo Taxotere odobreno v EU?
With the skeleton still in place, the cells cannot divide and they eventually die.
Če je ogrodje prisotno, se celice ne morejo deliti in sčasoma odmrejo.
Side effects reported with Taxotere are carefully evaluated and any necessary action taken to protect patients.
Neželeni učinki, o katerih so poročali pri zdravilu Taxotere, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Taxotere have been included in the summary of product characteristics and the package leaflet.
Priporočila in previdnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Taxotere upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
What are the risks associated with Taxotere?
Kakšna tveganja so povezana z zdravilom Taxotere?
Adding Taxotere to other anticancer treatments was effective in all five types of cancer.
Dodajanje zdravila Taxotere drugim zdravilom za zdravljenje raka je bilo učinkovito pri vseh petih vrstah raka.
Taxotere can be used on its own after other treatments have failed.
Zdravilo Taxotere se lahko uporablja samostojno po neuspešnih drugih oblikah zdravljenja.
Taxotere has been studied in over 4,000 breast-cancer patients, around 2,000 non-small-cell-lungcancer patients, around 2,700 prostate cancer patients, 457 gastric adenocarcinoma patients and 897 head- and neck-cancer patients.
Zdravilo Taxotere so proučevali pri več kot 4 000 bolnicah z rakom dojke, približno 2 000 bolnikih z nedrobnoceličnim pljučnim rakom, približno 2 700 bolnikih z rakom prostate, 457 bolnikih z želodčnim adenokarcinomom in 897 bolnikih z rakom glave in vratu.
Taxotere must not be used in patients who have a neutrophil count of less than 1,500 cells/mm3 or who have severe problems with their liver.
Zdravilo Taxotere se ne sme uporabljati pri bolnikih, pri katerih je število nevtrofilcev manjše od 1 500 celic/mm3, ali pri bolnikih s hudimi težavami z jetri.
• prostate cancer, when the cancer has spread to other parts of the body (metastatic).
• raka prostate, kadar se je rak razširil na druge dele telesa (je metastatski).
The dose of Taxotere may need to be reduced, or treatment interrupted or discontinued, if the patient develops certain side effects.
Odmerek zdravila Taxotere bo morda treba zmanjšati ali prekiniti oziroma ukiniti zdravljenje, če se pri bolniku pojavijo določeni neželeni učinki.
An overview of Taxotere and why it is authorised in the EU
Pregled zdravila Taxotere in zakaj je odobreno v EU
Taxotere is used with cisplatin and fluorouracil.
Zdravilo Taxotere se uporablja s cisplatinom in fluoroacilom.
Docetaxel blocks the ability of cells to break down the internal ‘skeleton' that allows them to divide.
Docetaksel zavira sposobnost celic, da uničijo notranje „ogrodje“, ki jim omogoča deljenje in razmnoževanje.
In most of these studies, Taxotere was combined with other cancer treatments and compared either with the medicines it is used in combination with or with a combination of different treatments.
V večini teh študij je bilo zdravilo Taxotere uporabljeno v kombinaciji z drugim zdravilom za zdravljenje raka in primerjano bodisi z zdravili, v kombinaciji s katerimi je bilo uporabljeno, bodisi s kombinacijami različnih zdravljenj.
Taxotere is a cancer medicine used to treat the following types of cancer:
Taxotere je zdravilo za zdravljenje raka, ki se uporablja za zdravljenje naslednjih vrst raka:
For more information about using Taxotere, see the package leaflet or contact your doctor or pharmacist.
Za več informacij glede uporabe zdravila Taxotere glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
• non-small cell lung cancer.
• nedrobnoceličnega pljučnega raka.
An anti-inflammatory medicine such as dexamethasone should also be given to the patient, starting on the day before the Taxotere infusion.
Bolniku je treba dati tudi protivnetno zdravilo, kot je na primer deksametazon, in sicer dan pred infuzijo zdravila Taxotere.
The most common side effects with Taxotere (seen in more than 1 patient in 10) are neutropenia (low levels of neutrophils, white blood cells that fight infection), anaemia (low red blood cell counts), stomatitis (inflammation of the lining of the mouth), diarrhoea, nausea (feeling sick), vomiting, alopecia (hair loss) and asthenia (weakness).
Najpogostejši neželeni učinki zdravila Taxotere (ki se lahko pojavijo pri več kot 1 od 10 bolnikov) so nevtropenija (nizke vrednosti nevtrofilcev, belih krvnih celic, ki se borijo proti okužbam), anemija (nizko število rdečih krvnih celic), stomatitis (vnetje ustne sluznice), driska, navzeja (siljenje na bruhanje), bruhanje, alopecija (izpadanje las) in astenija (šibkost).
• head and neck cancer in patients whose cancer is locally advanced (a cancer that has grown but has not spread).
• lokalno napredovalega raka glave in vratu pri bolnikih (rak je zrastel, vendar se ni razširil).
Because docetaxel works on dividing cells, it also affects affects non-cancer cells such as blood cells, which can cause side effects.
Docetaksel učinkuje na delitev celic, zato vpliva tudi na nerakave celice, kot so krvne celice, kar lahko povzroči neželene učinke.
The main measures of effectiveness were the number of patients whose cancer responded to treatment, how long the patients lived without their disease getting worse and how long the patients survived.
Glavno merilo učinkovitosti je bilo število bolnikov, pri katerih se je rak odzval na zdravljenje, čas do poslabšanja bolezni in čas preživetja.
It can also be used with androgen-deprivation therapy when hormonal treatment still works (hormone-sensitive prostate cancer);
Lahko se uporablja tudi s terapijo odtegnitve androgenov, kadar hormonsko zdravljenje še vedno deluje (rak prostate, občutljiv na hormone);
The dose, duration of treatment and the medicines it is used with depend on the type of cancer being treated and the patient's weight and height.
Odmerek, trajanje zdravljenja in njegova souporaba z drugimi zdravili so odvisni od vrste raka, ki se zdravi, ter bolnikove višine in telesne mase.
These side effects may be more severe when Taxotere is used with other cancer medicines.
Ti neželeni učinki so lahko resnejši, kadar se zdravilo Taxotere uporablja z drugimi zdravili za zdravljenje raka.
When used on its own, Taxotere was at least as effective as and sometimes more effective than the comparator medicines in breast cancer, and more effective than best supportive care (any medicines or treatment to help patients, but not other cancer medicines) in lung cancer.
Kadar se je zdravilo Taxotere uporabljalo samostojno, je bilo pri raku dojke enako ali včasih bolj učinkovito kot primerjalna zdravila, pri pljučnem raku pa učinkovitejše kot najboljša podporna nega (katera koli zdravila ali zdravljenja, ki bolnikom pomagajo, a niso druga zdravila za zdravljenje raka).
• gastric adenocarcinoma (a stomach cancer) that has spread in patients who have not received any treatment for their cancer.
• gastričnega adenokarcinoma (vrste želodčnega raka), ki se je razširil pri bolnikih, ki se zaradi raka še niso zdravili.
Taxotere is used with prednisone or prednisolone (anti-inflammatory medicines) when the cancer cannot be treated by greatly reducing the body's production of testosterone (castration-resistant prostate cancer).
Zdravilo Taxotere se uporablja s prednizonom ali prednizolonom (protivnetnima zdraviloma), kadar raka ni mogoče zdraviti z velikim zmanjšanjem proizvodnje testosterona (na kastracijo odporen rak prostate).
Taxotere is given as a 1-hour infusion (drip) into a vein every 3 weeks.
Zdravilo Taxotere se daje z enournim infundiranjem (kapalno infuzijo) v veno vsake tri tedne.
Taxotere is used with cisplatin and fluorouracil (other cancer medicines);
Zdravilo Taxotere se uporablja s cisplatinom in fluoroacilom (drugima zdraviloma za zdravljenje raka);
It can also be used with other cancer medicines (doxorubicin, cyclophosphamide, trastuzumab or capecitabine) in patients who have not yet received any treatment for their cancer or after other treatments have failed, depending on the type and stage of the breast cancer being treated;
Prav tako se lahko uporablja sočasno z drugimi zdravili za zdravljenje raka (doksorubicinom, ciklofosfamidom, trastuzumabom ali kapecitabinom) pri bolnikih, ki se še niso zdravili proti raku ali pri katerih so bile druge oblike zdravljenja neuspešne, kar je odvisno od vrste in stadija raka dojke, ki se zdravi;
The active substance in Taxotere, docetaxel, belongs to the group of cancer medicines known as taxanes.
Učinkovina v zdravilu Taxotere, docetaksel, spada v skupino zdravil za zdravljenje raka, imenovanih taksani.
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.