FrancophonIA/ELRC3.0 huggingface dataset:
English: Further information on Taxotere can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/taxotere.
Croatian: Više informacija o lijeku Taxotere dostupno je na internetskim stranicama Agencije: ema.europa.eu/medicines/human/EPAR/taxotere.
English: Taxotere (docetaxel)
Croatian: Taxotere (docetaksel)
English: Taxotere received a marketing authorisation valid throughout the EU on 27 November 1995.
Croatian: Lijek Taxotere dobio je odobrenje za stavljanje u promet koje je na snazi u EU-u od 27. studenoga 1995.
English: What measures are being taken to ensure the safe and effective use of Taxotere?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Taxotere?
English: Taxotere is given as a 1-hour infusion (drip) into a vein every 3 weeks.
Croatian: Taxotere se primjenjuje intravenskom infuzijom (ukapavanjem) u trajanju od jednog sata svaka tri tjedna.
English: What is Taxotere and what is it used for?
Croatian: Što je Taxotere i za što se koristi?
English: Other information about Taxotere
Croatian: Ostale informacije o lijeku Taxotere
English: 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.
Croatian: Glavna mjerila učinkovitosti bila su broj bolesnika čiji je rak odgovorio na terapiju, koliko se život bolesnika produljio bez pogoršanja bolesti i koliko se produljilo preživljenje bolesnika.
English: The European Medicines Agency decided that Taxotere's benefits are greater than its risks and it can be authorised for use in the EU.
Croatian: Europska agencija za lijekove zaključila je da koristi od lijeka Taxotere nadmašuju s njim povezane rizike te da lijek može biti odobren za primjenu u EU-u.
English: Side effects reported with Taxotere are carefully evaluated and any necessary action taken to protect patients.
Croatian: Nuspojave prijavljene za lijek Taxotere pažljivo se procjenjuju i poduzimaju se potrebne mjere za zaštitu bolesnika.
English: Adding Taxotere to other anticancer treatments was effective in all five types of cancer.
Croatian: Dodavanje lijeka Taxotere drugim lijekovima protiv raka bilo je učinkovito kod svih pet vrsta raka.
English: 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.
Croatian: Taxotere se ne smije primjenjivati u bolesnika kod kojih je broj neutrofila manji od 1 500 stanica/mm3 ili u bolesnika koji imaju ozbiljne probleme s jetrom.
English: Taxotere is a cancer medicine used to treat the following types of cancer:
Croatian: Taxotere je lijek protiv raka koji se primjenjuje za liječenje sljedećih vrsta raka:
English: 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.
Croatian: U većini ovih ispitivanja lijek Taxotere primjenjivao se u kombinaciji s drugim lijekovima protiv raka te se uspoređivao s lijekovima s kojima se uzimao u kombinaciji ili s kombinacijom različitih terapija.
English: 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.
Croatian: Lijek Taxotere ispitivan je u više od 4 000 oboljelih od raka dojke, otprilike 2 000 bolesnika oboljelih od raka pluća nemalih stanica, otprilike 2 700 bolesnika oboljelih od raka prostate, 457 bolesnika oboljelih od adenokarcinoma želuca i 897 bolesnika oboljelih od raka glave i vrata.
English: As for all medicines, data on the use of Taxotere are continuously monitored.
Croatian: Kao i za sve lijekove, podatci o primjeni lijeka Taxotere kontinuirano se prate.
English: What are the risks associated with Taxotere?
Croatian: Koji su rizici povezani s lijekom Taxotere?
English: 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).
Croatian: Najčešće nuspojave lijeka Taxotere (zabilježene u više od 1 na 10 bolesnika) jesu neutropenija (niske razine neutrofila, bijelih krvnih stanica koje se bore protiv infekcije), anemija (nizak broj crvenih krvnih zrnaca), stomatitis (upala sluznice usne šupljine), proljev, mučnina (slabost), povraćanje, alopecija (gubitak kose) i astenija (slabost).
English: Why is Taxotere authorised in the EU?
Croatian: Zašto je lijek Taxotere odobren u EU-u?
English: An overview of Taxotere and why it is authorised in the EU
Croatian: Pregled informacija o lijeku Taxotere i zašto je odobren u EU-u
English: The dose of Taxotere may need to be reduced, or treatment interrupted or discontinued, if the patient develops certain side effects.
Croatian: Dozu lijeka Taxotere možda će biti potrebno smanjiti ili liječenje privremeno ili trajno prekinuti ako se kod bolesnika pojave određene nuspojave.
English: 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.
Croatian: Preporuke i mjere opreza kojih se zdravstveni radnici i bolesnici trebaju pridržavati u cilju sigurne i učinkovite primjene lijeka Taxotere nalaze se u sažetku opisa svojstava i u uputi o lijeku.
English: Taxotere is used with cisplatin and fluorouracil.
Croatian: Taxotere se primjenjuje u kombinaciji s cisplatinom i fluorouracilom.
English: An anti-inflammatory medicine such as dexamethasone should also be given to the patient, starting on the day before the Taxotere infusion.
Croatian: Bolesnicima bi trebalo dati i protuupalni lijek kao što je deksametazon, čija bi primjena trebala početi dan prije infuzije lijeka Taxotere.
English: Taxotere is used with cisplatin and fluorouracil (other cancer medicines);
Croatian: Taxotere se primjenjuje u kombinaciji s cisplatinom i fluorouracilom (drugim lijekovima protiv raka);
English: Taxotere can be used on its own after other treatments have failed.
Croatian: Taxotere se može primjenjivati kao monoterapija nakon što druge terapije nisu bile uspješne.
English: For more information about using Taxotere, see the package leaflet or contact your doctor or pharmacist.
Croatian: Za više informacija o primjeni lijeka Taxotere pročitajte uputu o lijeku odnosno obratite se liječniku ili ljekarniku.
English: 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.
Croatian: Taxotere se izdaje samo na recept i treba se primjenjivati samo na odjelima specijaliziranima za kemoterapiju (primjenu lijekova za liječenje raka) pod nadzorom liječnika koji je kvalificiran za davanje kemoterapije.
English: These side effects may be more severe when Taxotere is used with other cancer medicines.
Croatian: Te nuspojave mogu biti teže ako se Taxotere primjenjuje s drugim lijekovima protiv raka.
English: 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).
Croatian: Taxotere se primjenjuje u kombinaciji s prednizonom ili prednizolonom (protuupalnim lijekovima) u slučajevima kada se rak ne može liječiti znatnim smanjenjem proizvodnje testosterona u tijelu (rak prostate otporan na kastraciju).
English: Because docetaxel works on dividing cells, it also affects affects non-cancer cells such as blood cells, which can cause side effects.
Croatian: S obzirom na to da docetaksel djeluje na diobu stanica, on djeluje i na stanice koje nisu stanice raka poput krvnih stanica, što može uzrokovati nuspojave.
English: Taxotere contains the active substance docetaxel.
Croatian: Taxotere sadrži djelatnu tvar docetaksel.
English: How does Taxotere work?
Croatian: Kako djeluje Taxotere?
English: What benefits of Taxotere have been shown in studies?
Croatian: Koje su koristi od lijeka Taxotere utvrđene u ispitivanjima?
English: • gastric adenocarcinoma (a stomach cancer) that has spread in patients who have not received any treatment for their cancer.
Croatian: • adenokarcinoma želuca (raka želuca) koji se proširio u bolesnika koji nisu još primili nikakvu terapiju za liječenje raka od kojeg boluju.
English: It can also be used with cisplatin (another cancer medicine) in patients who have not received any treatment for their cancer;
Croatian: Može se primjenjivati i u kombinaciji s cisplatinom (drugim lijekom protiv raka) u bolesnika koji nisu još primili nikakvu terapiju za liječenje raka od kojeg boluju;
English: The active substance in Taxotere, docetaxel, belongs to the group of cancer medicines known as taxanes.
Croatian: Djelatna tvar u lijeku Taxotere, docetaksel, pripada taksanima, skupini lijekova protiv raka.
English: How is Taxotere used?
Croatian: Kako se Taxotere primjenjuje?
English: 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.
Croatian: Također se pokazao učinkovitijim od najbolje potporne skrbi (svih lijekova ili terapije za pomoć bolesnicima, ali ne drugih lijekova protiv raka) kod raka pluća.
English: For the full list of side effects of Taxotere, see the package leaflet.
Croatian: Potpuni popis nuspojava povezanih s lijekom Taxotere potražite u uputi o lijeku.
English: 90 (3x30) tablets (multipack)
Croatian: 90 (3x30) tableta (Višestruko pakiranje)
English: MA (EU) number (Invented) name Strength Pharmaceutical Form Route of Administration Immediate Packaging Pack size EU/1/15/1068/001 Wakix
Croatian: Broj (EU) odobrenja (Zaštićeno) ime Jačina Farmaceutski oblik Put primjene Unutarnje pakiranje Veličina pakiranja EU/1/15/1068/001 Wakix
English: They will tell you what needs to be done.
Croatian: Oni će Vam reći što je potrebno učiniti.
English: TIME - hour
Croatian: VRIJEME - sati
English: If this happens you must seek urgent medical help.
Croatian: Ako se ovo dogodi, morate potražiti hitnu medicinsku pomoć.
English: THE FOLLOWING INFORMATION IS INTENDED FOR HEALTHCARE PROFESSIONALS ONLY:
Croatian: SLJEDEĆE INFORMACIJE NAMIJENJENE SU SAMO ZDRAVSTVENIM DJELATNICIMA:
English: Be careful when you start or stop taking another medicine.
Croatian: Budite oprezni kad započinjete ili prestajete uzimati drugi lijek.
English: Date of latest renewal: 20 August 2009
Croatian: Datum posljednje obnove odobrenja: 20. kolovoza 2009.
English: It is made by biotechnology.
Croatian: Ovaj lijek se proizvodi biotehnologijom.
English: If you experience the following symptoms, contact your doctor immediately:
Croatian: Ako iskusite sljedeće simptome, odmah se javite liječniku:
English: Apidra with alcohol
Croatian: Apidra s alkoholom
English: Do not stop Apidra without speaking to a doctor, who will tell you what needs to be done.
Croatian: Nemojte prestati primjenjivati lijek Apidra bez savjetovanja s liječnikom koji će Vam reći što je potrebno napraviti.
English: B. Select your required dose (in the example below, the selected dose is 30 units).
Croatian: Odaberite potrebnu dozu (u primjeru prikazanom ispod, odabrana je doza od 30 jedinica).
English: This is because the insulin may have lost some of its effectiveness.
Croatian: To je zbog toga što je inzulin možda izgubio na djelotvornosti.
English: These reactions are usually transitory and normally they disappear during continued treatment.
Croatian: Te su reakcije obično prolazne i u načelu se povlače tijekom kontinuiranog liječenja.
English: Your doctor will show you in which area of the skin you should inject Apidra.
Croatian: Liječnik će Vam pokazati u koje područje na koži trebate injicirati lijek Apidra.
English: This means you may not always get enough insulin to treat your diabetes.
Croatian: To znači da možda nećete uvijek dobiti dovoljno inzulina za liječenje vašeg dijabetesa.
English: Changing the injection site with each injection may help to prevent such skin changes.
Croatian: Promjena mjesta injiciranja kod svake injekcije može pomoći u sprečavanju takvih promjena na koži.
English: ATC code: A10AB06
Croatian: ATK oznaka: A10AB06
English: Some medicines cause changes in the blood sugar level (decrease, increase or both depending on the situation).
Croatian: Neki lijekovi uzrokuju promjene u razini šećera u krvi (sniženje, povišenje ili oboje, ovisno o situaciji).
English: Adjustment of dose may be also necessary if patients undertake increased physical activity or change their usual meal plan.
Croatian: Prilagođavanje doze može biti potrebno i ako bolesnik pojača tjelesnu aktivnost ili promijeni uobičajeni raspored obroka.
English: The average body mass index (BMI) of patients was 34.55 kg/m2.
Croatian: Prosječan indeks tjelesne mase (ITM) bolesnika iznosio je 34,55 kg/m2.
English: Other medicines and Apidra
Croatian: Drugi lijekovi i Apidra
English: The number in the dose window will return to “0” as you inject.
Croatian: Brojka u prozorčiću za doziranje vratit će se na “0” dok budete injicirali.
English: This can be serious if your blood glucose level becomes very high.
Croatian: To može postati ozbiljno ako razina glukoze u Vašoj krvi postane vrlo visoka.
English: These are serious side effects.
Croatian: Ovo su ozbiljne nuspojave.
English: This may constitute a risk in situations where these abilities are of special importance (e.g. driving a car or operating machines).
Croatian: To može predstavljati rizik u situacijama u kojima su takve sposobnosti posebno važne (primjerice, vožnja ili rukovanje strojevima).
English: Use the pump system recommended by your doctor.
Croatian: Koristite se inzulinskom pumpom koju Vam je preporučio liječnik.
English: It has a rapid onset within 10-20 minutes and a short duration, about 4 hours.
Croatian: Ima brz početak djelovanja (unutar 10-20 minuta) i kratko trajanje djelovanja (oko 4 sata).
English: It has a dark blue injection button with a raised ring on the top.
Croatian: Ima tamno plavo dugme za injiciranje s izdignutim prstenom na vrhu.
English: Failure to follow these specific instructions may lead to serious adverse events.
Croatian: Nepridržavanje ovih specifičnih uputa može dovesti do ozbiljnih nuspojava.
English: Your blood sugar levels may either rise or fall if you drink alcohol.
Croatian: Razina šećera u krvi može porasti ili pasti ako konzumirate alkohol.
English: This should be kept in mind if treatment with the combination of pioglitazone and Apidra is considered.
Croatian: Ovo treba imati na umu ako se razmatra liječenje kombinacijom pioglitazona i lijeka Apidra.
English: What Apidra looks like and contents of the pack
Croatian: Kako Apidra izgleda i sadržaj pakiranja
English: Empty pens must never be reused and must be properly discarded.
Croatian: Prazne brizgalice nikad se ne smiju ponovno upotrebljavati i moraju se odgovarajuće zbrinuti.
English: It is essential for patients with pre-existing or gestational diabetes to maintain good metabolic control throughout pregnancy.
Croatian: Vrlo je bitno da bolesnice s postojećim ili gestacijskim dijabetesom održavaju dobru metaboličku kontrolu tijekom trudnoće.
English: • Contamination and/or infection,
Croatian: • onečišćenje i/ili infekciju
English: Based on empirical knowledge from similar medicinal products, clinically relevant pharmacokinetic interactions are unlikely to occur.
Croatian: Na temelju empirijskog znanja o sličnim lijekovima nisu vjerojatne klinički značajne farmakokinetičke interakcije.
English: The plunger will reach the end of the cartridge when the total of 300 units of insulin has been used.
Croatian: Klip će doći do kraja uloška kad se potroši svih 300 jedinica inzulina.
English: Follow closely the instructions for dose, monitoring (blood tests), diet and physical activity (physical work and exercise) as discussed with your doctor.
Croatian: Pažljivo slijedite upute o doziranju, kontroli (pretrage krvi), prehrani i tjelesnoj aktivnosti (fizički rad i tjelovježba) o kojima ste razgovarali sa svojim liječnikom.
English: The use of other solutions has not been studied.
Croatian: Primjena drugih otopina nije ispitana.
English: Then the injection button should be held down 10 seconds before withdrawing the needle.
Croatian: Zatim dugme za injiciranje treba držati pritisnutim 10 sekundi prije nego se igla izvuče.
English: Insulin requirements may be altered during illness or emotional disturbances.
Croatian: Potrebe za inzulinom mogu se promijeniti tijekom bolesti ili emocionalnih poremećaja.
English: Studies on pharmacokinetic interactions have not been performed.
Croatian: Nisu provedena ispitivanja farmakokinetičkih interakcija.
English: If you have symptoms of low blood sugar, take actions to increase your blood sugar level immediately.
Croatian: Ako imate simptome niske razine šećera u krvi, odmah poduzmite mjere da povisite razinu šećera u krvi.
English: Side effects where the frequency cannot be estimated from the available data
Croatian: Nuspojave kojima se učestalost ne može procijeniti iz dostupnih podataka
English: If you use more Apidra than you should
Croatian: Ako primijenite više lijeka Apidra nego što ste trebali
English: Glucose must also be given intravenously, if the patient does not respond to glucagon within 10 to 15 minutes.
Croatian: Također se mora intravenski primijeniti glukoza ako bolesnik nakon 10 do 15 minuta ne reagira na glukagon.
English: What Apidra contains
Croatian: Što Apidra sadrži
English: Careful control of your diabetes, and prevention of hypoglycaemia, is important for the health of your baby.
Croatian: Pažljiva kontrola šećerne bolesti i sprečavanje hipoglikemije važni su za zdravlje Vašeg djeteta.
English: Most minor reactions to insulins usually resolve in a few days to a few weeks.
Croatian: Većina manjih reakcija na inzulin obično prolazi nakon nekoliko dana ili tjedana.
English: Apidra should be taken shortly (0-15 minutes) before or soon after meals.
Croatian: Apidra se treba primijeniti neposredno (0-15 minuta) prije ili ubrzo nakon obroka.
English: 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.
Croatian: Nakon injekcije glukagona bolesnika je potrebno nadzirati u bolnici kako bi se otkrio razlog pojave teške hipoglikemije i spriječile druge slične epizode.
English: The time of occurrence of hypoglycaemia depends on the action profile of the insulins used and may, therefore, change when the treatment regimen is changed.
Croatian: Vrijeme pojave hipoglikemije ovisi o profilu djelovanja primijenjenih inzulina i stoga se može promijeniti kad se mijenja režim liječenja.
English: The Apidra SoloStar is blue.
Croatian: Apidra SoloStar je plave boje.
English: Dose proportionality
Croatian: Proporcionalnost doza
English: Injection should be given immediately after mixing as no data are available regarding the mixtures made up a significant time before injection.
Croatian: Injekcija se mora dati neposredno nakon miješanja jer nema podataka o primjeni mješavina koje su pripremljene znatno prije injiciranja.
English: You may need to use Apidra with syringes or pens.
Croatian: Možda ćete morati koristiti lijek Apidra sa štrcaljkama ili brizgalicama.
English: Important information about some of the ingredients of Apidra
Croatian: Važne informacije o nekim sastojcima lijeka Apidra
English: The effect will be slightly quicker if the insulin is injected into your abdomen.
Croatian: Učinak će biti nešto brži kad se inzulin injicira u trbuh.
English: Carry some information with you to show you are a person with diabetes.
Croatian: Nosite sa sobom neku informaciju o tome da ste dijabetičar.
English: Special care before injection
Croatian: Posebna upozorenja prije injiciranja
English: On the x-axis, zero (arrow) is the start of a 15-minute meal.
Croatian: Na osi x nula (strelica) označava početak 15-minutnog obroka.
English: GLULISINE - pre REGULAR - 30 min
Croatian: GLULIZIN - prije OBIČNI - 30 min
English: 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.
Croatian: Ako imate bilo kakvih pitanja o SoloStar brizgalici ili o šećernoj bolesti, obratite se svom liječniku, ljekarniku ili medicinskoj sestri ili nazovite broj lokalnog sanofi-aventis ureda naveden na prednjoj strani ove Upute o lijeku.
English: Talk to your doctor, pharmacist or nurse before using Apidra.
Croatian: Obratite se svom liječniku, ljekarniku ili medicinskoj sestri prije nego primijenite lijek Apidra.
English: 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).
Croatian: Sljedeće nuspojave povezane s primjenom lijeka zabilježene u kliničkim ispitivanjima prikazane su prema organskim sustavima i u padajućem nizu prema incidenciji (vrlo često: ≥ 1/10; često: ≥ 1/100 i < 1/10; manje često: ≥ 1/1000 i < 1/100; rijetko: ≥ 1/10 000 i < 1/1000; vrlo rijetko: < 1/10 000; nepoznato (ne može se procijeniti iz dostupnih podataka).
English: Needles must not be reused.
Croatian: Igle se ne smiju ponovno upotrijebiti.
English: 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).
Croatian: Istraživanja reprodukcije kod životinja nisu pokazala razliku između inzulina glulizina i ljudskog inzulina što se tiče trudnoće, embrionalnog/fetalnog razvoja, poroda ili postnatalnog razvoja (vidjeti dio 5.3).
English: It is therefore recommended that the diabetic patient constantly carries some sugar lumps, sweets, biscuits or sugary fruit juice.
Croatian: Stoga se preporučuje da osoba sa šećernom bolešću stalno uz sebe ima kocke šećera, slatkiše, kekse ili zaslađeni voćni sok.
English: In general, to prevent hypoglycaemia you must eat more food and monitor your blood sugar.
Croatian: Općenito, kako biste spriječili hipoglikemiju morate uzimati više hrane i kontrolirati razinu šećera u krvi.
English: If you have proliferative retinopathy (an eye disease related to diabetes) severe hypoglycaemic attacks may cause temporary loss of vision.
Croatian: Ako imate proliferativnu retinopatiju (bolest očiju povezanu sa šećernom bolešću), teški napadi hipoglikemije mogu uzrokovati privremeni gubitak vida.
English: How to handle an infusion pump system
Croatian: Kako rukovati pumpom za infuziju
English: Apidra contains metacresol, which may cause allergic reactions.
Croatian: Apidra sadrži metakrezol koji može izazvati alergijske reakcije.
English: Step 3 Perform a safety test
Croatian: 3. korak Provođenje testa sigurnosti
English: However, hypoglycaemia may develop over sequential stages.
Croatian: Međutim, hipoglikemija se može razviti kroz nekoliko uzastopnih faza.
English: • Before each use, a new needle must always be carefully attached and a safety test must be performed.
Croatian: • Prije svake uporabe uvijek se mora pažljivo pričvrstiti nova igla i provesti test sigurnosti.
English: The time to 10% of total INS exposure was reached earlier by approximately 5-6 min with insulin glulisine.
Croatian: Vrijeme do postizanja 10% ukupne izloženosti inzulinu dosegnuto je otprilike 5-6 minuta ranije s inzulinom glulizinom.
English: What Apidra is and what it is used for
Croatian: Što je Apidra i za što se koristi