FrancophonIA/ELRC3.0 huggingface dataset:
English: In the third study, IPSS was around 19 points before treatment, falling by 7.0 points in the men who took Silodyx after 12 weeks, 6.7 points in the men who took tamsulosin and 4.7 points in the men who took placebo.
Croatian: U trećem ispitivanju IPSS je iznosio otprilike 19 bodova prije liječenja, pri čemu se nakon 12 tjedana smanjio za 7,0 bodova u muškaraca koji su uzimali Silodyx i za 6,7 bodova u muškaraca koji su uzimali tamsulozin te 4,7 bodova u muškaraca koji su uzimali placebo.
English: In addition, the company that makes Silodyx will ensure that eye surgeons are provided with information on IFIS in all Member States where the medicine will be marketed.
Croatian: Nadalje, proizvođač lijeka Silodyx osigurat će da se očnim kirurzima dostave sve informacije vezane uz IFIS u svim državama članicama u kojima se lijek stavlja u promet
English: After 12 weeks, it had fallen by around 6.4 points in the men who took Silodyx, and by around 3.5 points in the men who took placebo.
Croatian: Nakon 12 tjedana, rezultat se smanjio za 6,4 bodova u muškaraca koji su uzimali Silodyx i za otprilike 3,5 bodova u muškaraca koji su uzimali placebo.
English: What measures are being taken to ensure the safe and effective use of Silodyx?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Silodyx?
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Silodyx.
Croatian: Objašnjava kako je Odbor za lijekove za humanu uporabu (CHMP) ocijenio lijek da bi donio mišljenje u korist izdavanja odobrenja za stavljanje lijeka u promet i preporuke o uvjetima primjene za lijek Silodyx.
English: For more information about treatment with Silodyx, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o terapiji lijekom Silodyx pročitajte u uputi o lijeku (također dio EPAR-a) ili se obratite svom liječniku ili ljekarniku
English: The recommended dose is one 8 mg capsule once a day.
Croatian: Preporučena je doza jedna kapsula od 8 mg na dan.
English: When these receptors are activated, they cause the muscles controlling the flow of urine to contract.
Croatian: Kada se ti receptori aktiviraju, oni uzrokuju kontrakciju mišića koji kontroliraju protok urina.
English: By blocking these receptors, silodosin allows these muscles to relax, making it easier to pass urine and relieving the symptoms of BPH.
Croatian: Inhibirajući te receptore, silodozin omogućuje mišićima da se opuste, te olakšava prolaz urina i ublažava simptome BHP-a.
English: For men with moderate kidney problems, the starting dose should be 4 mg once a day.
Croatian: Kod muškaraca s umjerenim oštećenjima bubrega preporučuje se početna doza od 4 mg na dan.
English: Silodyx is used to treat the symptoms of benign prostatic hyperplasia (BPH, an enlarged prostate gland) in adults.
Croatian: Silodyx se koristi za liječenje simptoma benigne hiperplazije prostate (BHP, povećane prostate) u odraslih osoba.
English: The most common side effect with Silodyx (seen in more than 1 patient in 10) is a reduction in the amount of semen released during ejaculation.
Croatian: Najčešća nuspojava lijeka Silodyx (zabilježena kod više od 1 na 10 osoba) je smanjenje količine sjemena koje se izbacuje prilikom ejakulacije.
English: This is a summary of the European public assessment report (EPAR) for Silodyx.
Croatian: Ovo je sažetak europskoga javnog izvješća o ocjeni dokumentacije o lijeku (EPAR) za lijek Silodyx.
English: A risk management plan has been developed to ensure that Silodyx is used as safely as possible.
Croatian: Pripremljen je plan upravljanja rizikom kako bi se osigurala što sigurnija primjena lijeka Silodyx.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Silodyx, including the appropriate precautions to be followed by healthcare professionals and patients.
Croatian: Na temelju tog plana, u sažetku opisa svojstava lijeka kao i u uputi o lijeku za lijek Silodyx nalaze se sigurnosne informacije, uključujući odgovarajuće mjere opreza kojih se zdravstveni djelatnici i bolesnici trebaju pridržavati.
English: Silodyx was more effective than placebo and as effective as tamsulosin at reducing symptoms of BPH.
Croatian: Silodyx je bio djelotvorniji od placeba te jednako djelotvoran kao tamsulozin u ublažavanju simptoma BHP-a.
English: Intra operative floppy iris syndrome (IFIS) occurs in some patients taking alpha adrenoreceptor antagonists and may lead to complications during cataract surgery.
Croatian: Intraoperacijski sindrom meke šarenice (IFIS) nastupa u pojedinih bolesnika koji uzimaju antagoniste alfa adrenoreceptora te može rezultirati komplikacijama tijekom operacije katarakte.
English: The prostate gland is an organ found at the base of the bladder in men.
Croatian: Prostata je organ koji se nalazi u bazi mjehura u muškaraca.
English: The active substance in Silodyx, silodosin, is an alpha adrenoreceptor antagonist.
Croatian: Djelatna tvar lijeka Silodyx, silodozin, je antagonist alfa adrenoreceptora.
English: Silodyx has been compared with placebo (a dummy treatment) in three main studies involving over 1,800 men with BPH.
Croatian: Silodyx je uspoređen s placebom (liječenjem bez djelatne tvari) u tri glavna ispitivanja koja su obuhvatila više od 1 800 muškaraca s BHP-om
English: Other information about Silodyx
Croatian: Ostale informacije o lijeku Silodyx
English: IPSS is a rating of the patient's symptoms such as the inability to empty the bladder, and the urge to urinate repeatedly or to strain while urinating.
Croatian: IPSS predstavlja indeks kojim se vrednuju simptomi bolesnika poput nemogućnosti pražnjenja mjehura i potrebe za učestalim mokrenjem ili naprezanja prilikom mokrenja.
English: The CHMP decided that Silodyx's benefits are greater than its risks and recommended that it be given marketing authorisation.
Croatian: CHMP odlučio je da koristi od lijeka Silodyx nadmašuju s njim povezane rizike te je preporučio izdavanje odobrenja za stavljanje lijeka u promet.
English: Silodyx is a medicine that contains the active substance silodosin.
Croatian: Silodyx je lijek koji sadrži djelatnu tvar silodozin.
English: One of these studies also compared Silodyx with tamsulosin (another medicine used for BPH).
Croatian: U jednom od ovih ispitivanja Silodyx je također uspoređen s tamsulozinom (drugim lijekom za liječenje BHP-a).
English: Silodyx silodosin
Croatian: Silodyx silodozin
English: What is the risk associated with Silodyx?
Croatian: Koji su rizici povezani s lijekom Silodyx?
English: Silodyx is not recommended for patients with severe kidney problems.
Croatian: Primjena lijeka Silodyx ne preporuča se u bolesnika s ozbiljnim oštećenjem bubrega.
English: It works by blocking receptors called alpha1A adrenoreceptors in the prostate gland, the bladder and the urethra (the tube that leads from the bladder to the outside of the body).
Croatian: Djeluje inhibirajući receptore naziva alfa1A adrenoreceptori u prostati, mjehuru i mokraćnoj cijevi (cijevi koja vodi od mjehura do vanjskog dijela tijela).
English: IFIS is a condition that makes the iris floppy.
Croatian: IFIS je stanje koje šarenicu čini mekom.
English: Why has Silodyx been approved?
Croatian: Zašto je Silodyx odobren?
English: What is Silodyx?
Croatian: Što je Silodyx?
English: For the full list of all side effects and restrictions with Silodyx, see the package leaflet.
Croatian: Potpuni popis nuspojava i ograničenja zabilježenih pri primjeni lijeka Silodyx potražite u uputi o lijeku.
English: What benefit has Silodyx shown during the studies?
Croatian: Koje su koristi lijeka Silodyx utvrđene u ispitivanjima?
English: What is Silodyx used for?
Croatian: Za što se Silodyx koristi?
English: How is Silodyx used?
Croatian: Kako se Silodyx koristi?
English: How does Silodyx work?
Croatian: Kako djeluje Silodyx?
English: How has Silodyx been studied?
Croatian: Kako se Silodyx ispitivao?
English: If you use more Abseamed than you should
Croatian: Ako primijenite više Abseameda nego što ste trebali
English: Treatment with Abseamed is divided into two stages - correction and maintenance phase.
Croatian: Liječenje Abseamedom podijeljeno je u dvije faze - fazu korekcije i fazu održavanja.
English: The dose of Abseamed you receive is based on your body weight in kilograms.
Croatian: Doza Abseameda koju primate temelji se na Vašoj tjelesnoj težini u kilogramima.
English: Abseamed should be administered after the completion of the blood donation procedure.
Croatian: Abseamed treba primijeniti nakon završetka postupka donacije krvi.
English: • Only use Abseamed if it has been stored correctly - see section 5, How to store Abseamed.
Croatian: • Primijenite Abseamed samo ako je bio čuvan na ispravan način - vidjeti dio 5, Kako čuvati
English: If Abseamed is injected under the skin (subcutaneously), the amount injected is not normally more than one millilitre (1 mL) in a single injection.
Croatian: Ako se Abseamed ubrzigava pod kožu (supkutano), ubrizgana količina obično nije veća od jednog mililitra (1 ml) u jednoj injekciji.
English: For patients on peritoneal dialysis Abseamed may be given twice a week.
Croatian: Bolesnicima na peritonealnoj dijalizi Abseamed se može davati dva puta tjedno.
English: This section contains information on how to give yourself an injection of Abseamed.
Croatian: Ovaj dio sadrži informacije o tome kako da sami sebi date injekciju Abseamed.
English: Your doctor will monitor your blood pressure regularly while you are using Abseamed.
Croatian: Liječnik će Vam redovito nadzirati krvni tlak dok primate Abseamed.
English: Your doctor will help you to decide if Abseamed is suitable for you.
Croatian: Vaš liječnik će Vam pomoći odlučiti je li Abseamed pogodan za Vas.
English: Abseamed should not be used:
Croatian: Abseamed ne smijete koristiti:
English: During the maintenance phase, Abseamed can be administered either 3 times per week, and in the case of subcutaneous administration, once weekly or once every 2 weeks.
Croatian: Tijekom faze održavanja Abseamed se može primjenjivati ili 3 puta tjedno, a u slučaju supkutane primjene jednom tjedno ili jednom svaka 2 tjedna.
English: Abseamed may be given by injection:
Croatian: Abseamed se može dati injekcijom:
English: Abseamed has no or negligible influence on the ability to drive and use machines.
Croatian: Abseamed ne utječe ili zanemarivo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: Abseamed is given alone and not mixed with other liquids for injection.
Croatian: Abseamed se daje sam i ne smije se miješati s drugim tekućinama za injekciju.
English: • For adults and children Abseamed is given as an injection either into a vein (intravenously) or a tube that goes into a vein.
Croatian: • Odraslima i djeci Abseamed se daje ili kao injekcija u venu (intravenski) ili kroz cjevčicu koja ulazi u venu.
English: • You will usually continue Abseamed treatment for one month after the end of chemotherapy.
Croatian: • Obično ćete nastaviti s liječenjem Abseamedom još mjesec dana nakon završetka kemoterapije.
English: • Abseamed is given by injection under the skin.
Croatian: • Abseamed se daje injekcijom pod kožu.
English: What you need to know before you use Abseamed
Croatian: Što morate znati prije nego počnete primjenjivati Abseamed
English: Abseamed should be administered by the intravenous route.
Croatian: Abseamed treba primjenjivati intravenskim putem.
English: When this access (via a vein or tube) is not readily available, your doctor may decide that Abseamed should be injected under the skin (subcutaneously).
Croatian: Kada taj pristup (putem vene ili cjevčice) nije lako dostupan, Vaš liječnik može odlučiti da se Abseamed treba ubrizgavati pod kožu (supkutano).
English: Your doctor has carried out blood tests and decided you need Abseamed.
Croatian: Liječnik Vam je napravio krvne pretrage i odlučio da Vam je potreban Abseamed.
English: Iron supplements and other blood stimulants may increase the effectiveness of Abseamed.
Croatian: Dodaci sa željezom i drugi pripravci za jačanje krvi mogu povećati djelotvornost Abseameda.
English: What Abseamed looks like and contents of the pack
Croatian: Kako Abseamed izgleda i sadržaj pakiranja
English: Abseamed is provided with or without a needle safety guard and you will be shown how to use this by your doctor or nurse.
Croatian: Abseamed je dostupan sa ili bez zaštitnog mehanizma za iglu i Vaš liječnik ili medicinska sestra će Vam pokazati kako se koristi.
English: Talk to your doctor, pharmacist or nurse before using Abseamed.
Croatian: Obratite se svom liječniku, ljekarniku ili medicinskoj sestri prije nego primijenite Abseamed.
English: • If you do not respond adequately to Abseamed, your doctor will check your dose and will inform you if you need to change doses of Abseamed.
Croatian: • Ako ne budete odgovarali na liječenje Abseamedom na odgovarajući način, Vaš će liječnik provjeriti Vašu dozu i obavijestiti Vas ako trebate promijeniti doze Abseameda.
English: Later, your doctor may suggest that you or your caregiver learn how to inject Abseamed under the skin
Croatian: Kasnije Vaš liječnik može predložiti da Vi ili Vaš njegovatelj naučite kako sami davati Abseamed pod kožu
English: • Abseamed is given by injection into a vein immediately after you have donated blood for 3 weeks before your surgery.
Croatian: • Abseamed se daje injekcijom u venu, odmah nakon što ste donirali krv tijekom 3 tjedna prije operacije.
English: You may still be able to use Abseamed, but discuss it with your doctor first:
Croatian: Možda ćete i dalje moći primati Abseamed, ali prvo razgovarajte o tome sa svojim liječnikom:
English: Treatment with Abseamed has to be initiated under the supervision of physicians experienced in the management of patients with the above indications.
Croatian: Liječenje Abseamedom mora se započeti pod nadzorom liječnika s iskustvom u liječenju bolesnika s gore navedenim indikacijama.
English: If you are a cancer patient be aware that products that stimulate red blood cell production (like Abseamed) may act as a growth factor and therefore in theory may affect the progression of your cancer.
Croatian: Ako ste bolesnik koji ima rak morate znati da lijekovi koji potiču stvaranje crvenih krvnih stanica (kao Abseamed) mogu djelovati kao čimbenici rasta i tako teoretski mogu utjecati na daljnje napredovanje raka.
English: Abseamed can reduce the need for a blood transfusion.
Croatian: Abseamed može smanjiti potrebu za transfuzijom krvi.
English: • Your doctor may initiate treatment with Abseamed if your haemoglobin is 10 g/dL or less.
Croatian: • Liječnik može započeti liječenje Abseamedom ako Vam je vrijednost hemoglobina 10 g/dl ili manje.
English: In those situations in which the physician determines that a patient or caregiver can safely and effectively administer Abseamed subcutaneously themselves, instruction as to the proper dosage and administration should be provided.
Croatian: U situacijama u kojima liječnik ustanovi da bolesnik ili osoba koja se brine o bolesniku može sigurno i učinkovito primijeniti Abseamed supkutano, potrebno je dati upute o ispravnom doziranju i primjeni.
English: Medice Arzneimittel Pütter GmbH & Co. KG, Kuhloweg 37, D-58638 Iserlohn, Germany
Croatian: Medice Arzneimittel Pütter GmbH & Co KG, Kuhloweg 37, D-58638 Iserlohn, Njemačka
English: • The usual starting dose of Abseamed for adults and children is 50 International Units (IU) per kilogram (/kg) of body weight given three times a week.
Croatian: • Uobičajena početna doza Abseameda za odrasle i djecu je 50 međunarodnih jedinica (IU) po kilogramu (/kg) tjelesne težine i daje se tri puta tjedno.
English: If you visit a hospital, clinic or family doctor, tell them you are having Abseamed treatment.
Croatian: Ako morate ići u bolnicu, na kliniku ili obiteljskom liječniku, recite im da se liječite Abseamedom.
English: Inject the Abseamed solution as you have been shown by your doctor.
Croatian: Ubrizgajte otopinu Abseamed kako Vam je pokazao liječnik.
English: Abseamed can reduce the need for a blood transfusion in these patients.
Croatian: Abseamed može smanjiti potrebu za transfuzijom krvi u tih bolesnika.
English: Abseamed is indicated in adults in a predonation programme to increase the yield of autologous blood.
Croatian: Abseamed je indiciran u odraslih u predonacijskom programu za povećanje količine autologne krvi.
English: • Abseamed is given by injection under the skin each week for three weeks before surgery and on the day of surgery.
Croatian: • Abseamed se daje injekcijom pod kožu svaki tjedan tijekom tri tjedna prije kirurškog zahvata i na sam dan kirurškog zahvata.
English: Abseamed should be administered as a subcutaneous injection.
Croatian: Abseamed treba primijeniti kao supkutanu injekciju.
English: • Your doctor will order blood tests, and may adjust the dose, depending on how your anaemia responds to Abseamed treatment.
Croatian: • Liječnik će zatražiti krvne pretrage i možda prilagoditi dozu, ovisno o odgovoru Vaše anemije na liječenje Abseamedom.
English: • if you have been diagnosed with Pure Red Cell Aplasia (the bone marrow cannot produce enough red blood cells) after previous treatment with any product that stimulates red blood cell production (including Abseamed).
Croatian: • ako Vam je dijagnosticirana izolirana aplazija crvene krvne loze (koštana srž ne može proizvesti dovoljno crvenih krvnih stanica) nakon prethodnog liječenja bilo kojim lijekom koji potiče stvaranje crvenih krvnih stanica (uključujući Abseamed).
English: You may still be able to use Abseamed, but discuss it with your doctor first.
Croatian: Možda ćete i dalje moći primati Abseamed, ali prvo razgovarajte o tome s Vašim liječnikom.
English: Tell your doctor if you are taking, have recently taken or might take any other medicines.
Croatian: Drugi lijekovi i Abseamed Obavijestite svog liječnika ako uzimate, nedavno ste uzeli ili biste mogli uzeti bilo koje druge lijekove.
English: If you forget to use Abseamed
Croatian: Ako ste zaboravili primijeniti Abseamed
English: If you are a cancer patient, be aware that use of Abseamed may be associated with shorter survival and a higher death rate in head and neck, and metastatic breast cancer patients who are receiving chemotherapy.
Croatian: Ako ste bolesnik koji ima rak, morate znati da primjena Abseameda može biti povezana s kraćim preživljenjem i višom stopom smrti u bolesnika s rakom glave i vrata i metastatskim rakom dojke koji primaju kemoterapiju.
English: Tell your doctor or nurse immediately if you are aware of any of these effects, or if you notice any other effects while you are receiving treatment with Abseamed.
Croatian: Odmah obavijestite liječnika ili medicinsku sestru ako primijetite bilo koju od ovih nuspojava ili ako primijetite bilo kakve druge učinke dok primate Abseamed.
English: What Abseamed contains
Croatian: Što Abseamed sadrži
English: If you are taking a medicine called cyclosporin (used e.g. after kidney transplants), your doctor may order blood tests to check the level of cyclosporin while you are taking Abseamed.
Croatian: Ako uzimate lijek koji se zove ciklosporin (uzima se npr., nakon presađivanja bubrega), liječnik će raditi krvne pretrage kako bi provjerio razinu ciklosporina dok primate Abseamed.
English: If you are given a product in this group other than Abseamed during your treatment, speak to your doctor or pharmacist before using it.
Croatian: Ako za vrijeme liječenja dobijete neki drugi lijek iz ove skupine koji nije Abseamed, razgovarajte o tome sa svojim liječnikom ili ljekarnikom prije nego što ga uzmete.
English: - Patients who develop pure red cell aplasia (PRCA) following treatment with any erythropoietin should not receive Abseamed or any other erythropoietin (see section 4.4).
Croatian: - Bolesnici koji razviju izoliranu aplaziju crvene loze (engl. pure red cell aplasia, PRCA) nakon liječenja bilo kojim eritropoetinom ne smiju primiti Abseamed ili bilo koji drugi eritropoetin (vidjeti dio 4.4).
English: Abseamed and other products that stimulate red cell production may increase the risk of developing blood clots in all patients.
Croatian: Abseamed i drugi lijekovi koji potiču stvaranje crvenih krvnih stanica mogu povećati rizik od nastajanja krvnih ugrušaka u svih bolesnika.
English: Do not administer Abseamed by intravenous infusion or in conjunction with other medicinal product solutions (please refer to section 6.6 for further information).
Croatian: Nemojte primjenjivati Abseamed intravenskom infuzijom ili zajedno s otopinom drugog lijeka (vidjeti dio 6.6 za dodatne informacije).
English: • You may be given iron supplements before and during Abseamed treatment to make it more effective.
Croatian: • Možda ćete prije i tijekom terapije Abseamedom dobivati dodatke sa željezom kako bi liječenje bilo djelotvornije.
English: If you can't take medicines that prevent blood clotting, you must not have Abseamed.
Croatian: Ako ne smijete uzimati lijekove za sprječavanje zgrušavanja krvi, ne smijete primati Abseamed.
English: ANNEX II A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
Croatian: ODGOVORAN ZA PUŠTANJE SERIJE LIJEKA U PROMET B. UVJETI ILI OGRANIČENJA VEZANI UZ OPSKRBU I PRIMJENU C. OSTALI UVJETI I ZAHTJEVI ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET
English: • Always use Abseamed exactly as instructed by your doctor or nurse.
Croatian: • Uvijek primijenite Abseamed točno onako kako su Vam rekli liječnik ili medicinska sestra.
English: Abseamed is used in moderately anaemic adults who donate some of their blood before surgery, so that it can be given back to them during or after the operation.
Croatian: Abseamed se primjenjuje u odraslih s umjerenom anemijom koji daju krv prije odlaska na operaciju, kako bi im se ta krv mogla vratiti tijekom ili nakon operacije.
English: • You may take Abseamed out of the refrigerator and keep it at room temperature (up to 25°C) for no longer than 3 days.
Croatian: • Možete izvaditi Abseamed iz hladnjaka i čuvati ga na sobnoj temperaturi (do 25 °C) najviše
English: Mildly anaemic patients (haematocrit of 33 to 39%) requiring predeposit of ≥ 4 units of blood should be treated with Abseamed 600 IU/kg intravenously, 2 times per week for 3 weeks prior to surgery.
Croatian: Blago anemične bolesnike (hematokrit od 33 do 39%) koji moraju pohraniti ≥ 4 jedinice krvi treba liječiti s 600 IU/kg Abseameda intravenski 2 puta tjedno tijekom 3 tjedna prije operacije.
English: Do not shake Abseamed syringes.
Croatian: Nemojte tresti štrcaljke Abseamed.
English: - All contraindications associated with autologous blood predonation programmes should be respected in patients being supplemented with Abseamed.
Croatian: - Sve kontraindikacije vezane uz programe autologne predonacije krvi moraju se poštovati u bolesnika koji primaju Abseamed.
English: The recommended starting dose is Abseamed 450 IU/kg (maximum total dose is 40,000 IU) administered subcutaneously once every week, with not less than 5 days between doses.
Croatian: Preporučena početna doza je Abseamed 450 IU/kg (maksimalna ukupna doza je 40 000 IU) primijenjena supkutano jednom svakog tjedna, s ne manje od 5 dana između doza.