FrancophonIA/ELRC3.0 huggingface dataset:
English: No studies have been performed to assess the effect of Quadramet on reproduction.
Croatian: Nisu provedena ispitivanja učinka Quadrameta na sposobnost reprodukcije.
English: The presence of osteoblastic metastases which take up technetium (99mTc)-labelled biphosphonates should be confirmed prior to therapy.
Croatian: Postojanje osteoblastičnih metastaza koje na sebe vežu bifosfonate obilježene tehnecijem (99mTc) nužno je potvrditi prije početka primjene lijeka.
English: Other medicines and Quadramet Tell your doctor if you are taking or have recently taken or might take any other medicines.
Croatian: Obavijestite svog liječnika ako uzimate, ili stenedavno uzeli ili biste mogli uzeti bilo koje druge lijekove.
English: You may exceptionally feel a slight increase in bone pain a few days after Quadramet injection.
Croatian: Iznimno možete osjetiti lagano pojačanje koštane boli nekoliko dana nakon injekcije Quadrameta.
English: In absence of clinical data, the injected activity should be adapted to the renal function.
Croatian: U nedostatku kliničkih podataka injiciranu aktivnost potrebno je prilagoditi bubrežnoj funkciji.
English: Total skeletal uptake of Quadramet in studies of 453 patients with a variety of primary malignancies was 65.5 ± 15.5 % of the administered activity.
Croatian: Ukupna koštana apsorpcija Quadrameta u ispitivanjima provedenim na 453 bolesnika s različitim primarnim malignim bolestima, iznosila je 65,5 ± 15,5 % primijenjene radioaktivnosti.
English: Quadramet should be used within 6 hours of thawing.
Croatian: Quadramet je potrebno upotrijebiti unutar 6 sati od odmrzavanja.
English: The clearance of Quadramet being rapid, the precautions relating to the excreted urinary radioactivity need not be taken after 6-12 hours following administration.
Croatian: Klirens Quadrameta je brz, stoga mjere opreza zbog urinom izlučene radioaktivnosti nisu potrebne nakon 6 - 12 sati od primjene lijeka.
English: A minimum interval of 8 weeks should be respected, subject to recovery of adequate bone marrow function.
Croatian: Potrebno je učiniti pauzu od minimalno 8 tjedana kako bi se omogućio odgovarajući oporavak funkcije koštane srži.
English: Studies in rats have demonstrated that Quadramet is cleared rapidly from the blood and localises to growing areas of bone matrix, specifically the layer of osteoid undergoing mineralisation.
Croatian: Ispitivanja na štakorima pokazala su da se Quadramet brzo uklanja iz krvi i lokalizira u području rasta koštanog matriksa, naročito u osteoidnom sloju koji se mineralizira.
English: Repeated dose administration of samarium (153Sm)-EDTMP to dogs indicated a slightly longer time for depressed bone marrow and peripheral haematological parameters to recover when compared to recovery following only single dose administration.
Croatian: Ponavljane primijenjene doze samarija (153Sm)-EDTMP kod pasa upućivale su na blago produženo vrijeme oporavka funkcije koštane srži i perifernih hematoloških parametara u usporedbi s oporavkom nakon primjene samo jedne doze.
English: Special precautions, such as bladder catheterisation, should be taken during six hours following administration to incontinent patients to minimise the risk of radioactive contamination of clothing, bed linen, and the patient's environment.
Croatian: Posebne mjere opreza, poput kateterizacije mokraćnog mjehura, potrebne su kod inkontinentnih bolesnika tijekom 6 sati nakon primjene lijeka, a u cilju maksimalnog smanjenja rizika radioaktivne kontaminacije odjeće, posteljine i bolesnikovog okruženja.
English: In a carcinogenic potential study of EDTMP, osteosarcomas occurred in rats at high doses.
Croatian: U ispitivanjima kancerogenog potencijala EDTMPa primijećena je pojava osteosarkoma kod štakora pri visokim dozama.
English: 1.3 GBq/ml at reference date.
Croatian: 1,3 GBq/ml na referentni datum.
English: Your doctor will take blood samples weekly for at least 8 weeks to check your platelets, white and red blood cell counts which may slightly decrease due to the therapy.
Croatian: Vaš će Vam liječnik jednom tjedno tijekom najmanje 8 tjedana uzimati uzorke krvi kako bi provjerio broj trombocita, leukocita i eritrocita čiji se broj zbog liječenja može malo smanjiti.
English: Because Quadramet contains small amounts of a radioactive element, samarium-153, radiations are delivered locally to the bone lesions, allowing to develop the palliative action on bone pain.
Croatian: Budući da Quadramet sadrži malu količinu radioaktivnog elementa samarija-153, radioaktivno zračenje djeluje lokalno na koštane promjene, omogućujući na taj način ublažavanje koštane boli.
English: At 12 hours, 35.3 ± 13.6 % of the administered activity had been excreted into the urine.
Croatian: Nakon 12 sati 35,3 ± 13,6 % aplicirane radioaktivnosti izlučeno je u urin.
English: Gamma * Maximum energies are listed for the beta emissions, the average beta particle energy is
Croatian: * Maksimumi energija navedeni su za beta emisiju, prosječna energija beta čestice je 233 keV.
English: Quadramet is used only as a palliative agent and should not be used concurrently with myelotoxic chemotherapy as this may enhance myelotoxicity.
Croatian: Quadramet se primjenjuje samo kao palijativno sredstvo i ne smije se primijenjivati istovremeno s mijelotoksičnom kemoterapijom jer to može pojačati mijelotoksičnost.
English: The primary radiation emissions of samarium-153 are shown in Table 1.
Croatian: Glavne vrste emisije zračenja koje nastaju raspadom samarija-153 prikazane su u tablici 1.
English: In the absence of genotoxic properties, these effects can be assigned to the EDTMP chelatant properties leading to osseous metabolism disturbances.
Croatian: S obzirom na odsutnost genotoksičnih svojstava, ovi se učinci mogu pripisati kelirajućim svojstvima EDTMPa koja dovode do poremećaja koštanog metabolizma.
English: This is the reason why your blood counts will be monitored strictly for a few weeks following Quadramet injection.
Croatian: To je razlog zbog čega će Vam često provjeravati krvnu sliku nekoliko tjedana nakon injekcije Quadrameta.
English: Absorbed dose per injected activity (mGy/MBq)
Croatian: Apsorbirana doza zračenja po injiciranoj aktivnosti (mGy/MBq)
English: Quadramet is a medicinal product for therapeutic use only.
Croatian: Quadramet je lijek koji se koristi isključivo u svrhu liječenja.
English: Thirty minutes after injection of the agent to 22 patients, only 9.6 ± 2.8 % of the administered activity remained in plasma.
Croatian: U 22 bolesnika, 30 minuta nakon injekcije lijeka, samo je 9,6 ± 2,8 % aplicirane radioaktivnosti izmjereno u plazmi.
English: Bladder catheterisation should be undertaken in patients with urinary obstruction.
Croatian: Kateterizacija mokraćnog mjehura potrebna je i u bolesnika s urinarnom opstrukcijom.
English: The patient should be encouraged to ingest (or receive by intravenous administration) a minimum of 500 ml of fluids prior to injection and should be encouraged to void as often as possible after injection to minimise radiation exposure to the bladder.
Croatian: Bolesnika je potrebno savjetovati da prije primjene lijeka popije (ili primi intravenski) najmanje 500 ml tekućine, te isto tako da nakon primjene lijeka mokri što češće, kako bi se maksimalno smanjilo izlaganje mokraćnog mjehura radioaktivnom zračenju.
English: When there are spinal metastases at the cervico-dorsal level, an increased risk of spinal cord compression cannot be excluded.
Croatian: Kod postojanja spinalnih metastaza u području cervikotorakalnog prijelaza, povećani rizik za nastanak kompresije leñne moždine ne može se isključiti.
English: In rare cases, the following undesirable effects have been observed: neuralgia, coagulation disorders, cerebrovascular accidents.
Croatian: U rijetkim slučajevima opisane su i sljedeće nuspojave: neuralgija, poremećaji zgrušavanja, cerebrovaskularni dogañaji.
English: The few patients who experienced Grade 3 or 4 hematopoietic toxicity usually either had a history of recent external beam radiation therapy or chemotherapy or had rapidly progressive disease with probable bone marrow involvement.
Croatian: Nekoliko bolesnika kod kojih se pojavio stupanj 3 ili 4 toksičnog učinka na hematopoezu, bili su nedavno liječeni radioterapijom ili kemoterapijom, ili su imali brzo progredirajuću bolest s vjerojatnom infiltracijom koštane srži.
English: He/she will be released when exposure rates comply with the limits prescribed by the regulations in force.
Croatian: Bolesnik/bolesnica bit će otpušten/a kad stupanj izloženosti bude u skladu s granicama koje odreñuju važeći propisi.
English: For the other patients the urine should be collected for at least 6 hours.
Croatian: Kod ostalih bolesnika mokraću je potrebno sakupljati kroz najmanje 6 sati.
English: The possibility of pharmacological overdose is therefore remote.
Croatian: Mogućnost predoziranja lijekom je stoga vrlo mala.
English: Radiation dose estimates for bone and marrow assume that radioactivity is deposited on bone surfaces, in accordance with autoradiograms of bone samples taken from patients who received Quadramet.
Croatian: Procjena doze zračenja za kost i koštanu srž temelje se na pretpostavci da se radioaktivnost nakuplja na površini kosti, u skladu s autoradiogramima koštanih uzoraka bolesnika koji su primili Quadramet.
English: Because of potential bone marrow suppression after administration, blood counts should be monitored weekly for at least 8 weeks, beginning 2 weeks after administration of Quadramet, or until recovery of adequate bone marrow function.
Croatian: Zbog moguće supresije koštane srži nakon primjene lijeka, potrebno je pratiti vrijednosti krvne slike svakog tjedna, tijekom najmanje 8 tjedana, počevši od drugog tjedna nakon primjene Quadrameta, ili do opravka odgovarajuće funkcije koštane srži.
English: Each vial contains 2-4 GBq at the reference date.
Croatian: Svaka bočica sadrži 2-4 GBq na referentni datum.
English: Quadramet may be given subsequent to either of these treatments after allowing for adequate marrow recovery.
Croatian: Quadramet se smije primijeniti nakon bilo kojeg od navedenih oblika liječenja samo nakon odgovarajućeg oporavka koštane srži.
English: If Quadramet administration to a breastfeeding woman is deemed necessary, breastfeeding should be stopped.
Croatian: Ako je Quadramet neophodno potrebno primijeniti ženi koja doji, dojenje je potrebno prekinuti.
English: Thus, areas of metastatic involvement can accumulate significantly greater amounts of Quadramet than surrounding normal bone.
Croatian: Dakle, područja zahvaćena metastazama mogu nakupljati značajno veću količinu Quadrameta od okolne zdrave kosti.
English: One single dose of 37 megabecquerel (Becquerel is the unit in which radioactivity is measured) of Quadramet per kilogram of body weight is to be injected.
Croatian: Injicirat će Vam jednu dozu od 37 megabekerela (Becquerel je jedinica kojom se mjeri radioaktivnost) Quadrameta po kilogramu tjelesne težine.
English: Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2)
Croatian: Lijek se izdaje na ograničeni recept (Vidjeti Dodatak I: Sažetak opisa svojstava lijeka, dio 4.2)
English: Adverse drug reactions such as nausea, vomiting, diarrhoea and sweating were reported.
Croatian: Prijavljene su i nuspojave poput mučnine, povraćanja, proljeva i znojenja.
English: Radiopharmaceuticals should be prepared by the user in a manner which satisfies both radiation safety and pharmaceutical quality requirements.
Croatian: Radiofarmaceutike je potrebno pripremati na način koji osigurava zaštitu od zračenja i farmaceutsku kakvoću.
English: The radiation dose resulting from therapeutic exposure may result in higher incidence of cancer and mutations.
Croatian: Doza zračenja nakon terapijske izloženosti radiofarmaceuticima može rezultirati većom incidencijom pojave karcinoma i mutacija.
English: In clinical trials white blood cell and platelet counts decreased to a nadir of approximately 40 % to 50 % of baseline 3 to 5 weeks after a dose, and generally returned to pre-treatment levels by 8 weeks post treatment.
Croatian: U kliničkim ispitivanjima broj leukocita i trombocita pao je do najniže vrijednosti koja je iznosila približno 40-50% početnih vrijednosti, 3 do 5 tjedana nakon primjene doze, i općenito se vraćala na razine prije liječenja 8 tjedana nakon završetka liječenja.
English: It should not be used concurrently with other biphosphonates if an interference is shown on the technetium (99mTc)-labelled biphosphonate bone scans.
Croatian: Takoñer se ne smije primijenjivati s drugim bifosfonatima ako je na scintigrafiji kostiju pomoću tehnecijem (99mTc) obilježenog bifosfonata primijećena interferencija.
English: Clear, colourless to light amber solution with pH ranging between 7.0 and 8.5.
Croatian: Bistra, bezbojna do svijetlo jantarna otopina, pH vrijednosti izmeñu 7,0 i 8,5.
English: If you have any further questions on the use of this product, ask your doctor or pharmacist.
Croatian: Imate li još pitanja o uporabi ovog lijeka, pitajte svog liječnika ili ljekarnika.
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu.
Croatian: Ove uputa je zadnji puta revidirana u {MM/GGGG} Detaljne informacije o ovom lijeku dostupne su na web stranici Europske agencije za lijekove: http://www.ema.europa.eu.
English: Quadramet has an affinity for skeletal tissue and concentrates in areas of bone turnover in intimate association with hydroxyapatite.
Croatian: Quadramet posjeduje afinitet za koštano tkivo i koncentrira se u područjima koštane pregradnje vezanjem za hidroksiapatit.
English: Radiation protection precautions in accordance with national regulations must therefore be taken.
Croatian: Moraju se poduzeti mjere zaštite od zračenja prema odredbama nacionalnih propisa.
English: In the case of urine incontinence or urinary obstruction you will get a urine catheter for about 6 hours.
Croatian: U slučaju nemogućnosti zadržavanja mokraće, ili nemogućnosti izlučivanja mokraće, postavit će Vam se urinarni kateter na otprilike 6 sati.
English: Solution for injection in a single-dose vial.
Croatian: Otopina za injekciju u jednodoznoj bočici.
English: (12 h CET) METHOD AND ROUTE(S) OF ADMINISTRATION Read the package leaflet before use For intravenous use
Croatian: (12 h SEV) NAČIN I PUT(EVI) PRIMJENE LIJEKA Prije uporabe pročitati uputu o lijeku.
English: Use within 6 hours of thawing.
Croatian: Upotrijebiti unutar 6 sati nakon odmrzavanja.
English: Method and route of administration Quadramet is to be administered by slow injection into a vein.
Croatian: Način i put primjene Quadramet se primjenjuje sporim ubrizgavanjem u venu.
English: CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
Croatian: UVJETI I OGRANIČENJA VEZANI UZ OPSKRBU I PRIMJENU
English: The product should only be administered by qualified personnel in authorised settings.
Croatian: Ovaj lijek smije primjenjivati samo kvalificirano osoblje u za to odobrenim ustanovama.
English: The solution for injection should be visually inspected before use.
Croatian: Prije uporabe potrebno je vizualno pregledati otopinu za injekciju.
English: Biotransformation Analysis of urine samples found the radioactivity to be present as the intact complex
Croatian: Biotransformacija Analizom uzoraka urina utvrñeno je da radioaktivnost u urinu potječe od neizmijenjenog spoja.
English: Pharmacotherapeutic group: Various pain palliation radiopharmaceuticals.
Croatian: Farmakoterapijska skupina: Različiti radiofarmaceutici za palijativno liječenje boli.
English: EXPIRY DATE EXP: DD/MM/YYYY (12 h CET)
Croatian: ROK VALJANOSTI EXP: DD/MM/GGGG (12 h SEV)
English: If therefore Quadramet administration is deemed necessary, formula feeding should be substituted for breastfeeding and the expressed feeds discarded.
Croatian: Stoga, ako je primjena Quadrameta neophodna, dojenje je potrebnno zamijeniti umjetnom hranom, a izdojeno mlijeko baciti.
English: (See section 12, for detailed instructions of product preparation)
Croatian: (Za detaljne upute o pripremi lijeka vidjeti dio 12)
English: Quadramet is to be administered by slow intravenous route through an established intravenous line over a period of one minute.
Croatian: Quadramet se primjenjuje sporom intravenskom injekcijom tijekom jedne minute kroz prethodno uspostavljeni venski put.
English: The dosimetry estimates were based on clinical biodistribution studies using methods developed for radiation dose calculations by the Medical Internal Radiation Dose (MIRD) Committee of the Society of Nuclear Medicine.
Croatian: Procijenjene apsorbirane doze zračenja za prosječnog odraslog bolesnika nakon intravenske injekcije Quadrameta prikazane su u tablici 2. Dozimetrijske procjene bazirane su na kliničkim ispitivanjima biodistribucije u kojima je korištena metoda izračuna doza radijacije prema Medical Internal Radiation Dose (MIRD) Committee, Društva za nuklearnu medicinu.
English: Hospital personnel will ensure that the product is stored correctly and not administered to you after the stated expiry date.
Croatian: Bolničko će se osoblje pobrinuti da se lijek čuva na ispravan način i da se na vama primjeni unutar navedenog roka valjanosti.
English: Warnings and precautions Talk to your doctor before taking Quadramet.
Croatian: Obratite se svom liječniku prije nego primijenite Quadramet.
English: In clinical studies employing planar imaging techniques, Quadramet accumulates with a lesion-tonormal bone ratio of approximately 5 and a lesion-to-soft tissue ratio of approximately 6.
Croatian: U kliničkim ispitivanjima u kojima su korištene planarne slikovne tehnike, Quadramet se nakupljao približno 5 puta više u kosti s lezijom u odnosu na zdravu kost, i približno 6 puta više u kosti s lezijom u odnosu na meka tkiva.
English: The occurrence of these events may be linked to the patients' disease evolution.
Croatian: Pojava ovih dogañaja može se povezati s napredovanjem osnovne bolesti.
English: Patients who respond to Quadramet generally experience the onset of pain relief within 1 week after treatment.
Croatian: U bolesnika s pozitivnim odgovorom na Quadramet uglavnom dolazi do smanjenja bolova unutar 1 tjedna od primjene lijeka.
English: Less urinary excretion occurred in patients who had extensive bony metastases, regardless of the amount of radiopharmaceutical administered.
Croatian: Smanjeno izlučivanje urinom primijećeno je u bolesnika s opsežnim koštanim metastazama neovisno o količini primijenjenog radiofarmaceutika.
English: EXP: DD/MM/YYYY (12 h CET)
Croatian: Rok valjanosti: DD/MM/GGGG (12 h SEV)
English: Red marrow Bone surfaces Skin
Croatian: Crvena koštana srž
English: A positive correlation was found between skeletal uptake and the number of metastatic sites.
Croatian: Utvrñen je pozitivni odnos izmeñu apsorpcije u kostima i broja koštanih metastaza.
English: Children and adolescents Quadramet is not recommended for use in children below 18 years of age.
Croatian: Ovaj lijek nije namijenjen za primjenu u djece mlañe od 18 godina.
English: Allow the product to thaw at room temperature before administration.
Croatian: Prije uporabe ostavite lijek na sobnoj temperaturi radi odmrzavanja.
English: For radiation safety reasons, the patient should be treated in a facility with the appropriate agreement for the therapeutic use of radioactive non-sealed sources.
Croatian: Zbog zaštite od zračenja, bolesnici ovaj lijek moraju primati u ustanovama koje posjeduju odgovarajuću dozvolu za terapijsku primjenu otvorenih izvora radioaktivnog zračenja.
English: • Hypersensitivity to the active substance (ethylenediaminetetramethylenephosphonate (EDTMP)
Croatian: • Preosjetljivost na djelatnu tvar (etilendiamintetrametilenfosfonat (EDTMP) ili slične fosfonate)
English: A few patients experienced cord/root compressions, disseminated intravascular coagulation and cerebrovascular accidents.
Croatian: U nekoliko bolesnika opisana je spinalna kompresija/kompresija spinalnih korjenova, diseminirana intravaskularna koagulacija i cerebrovaskularni dogañaji.
English: Hypersensitivity reactions including rare cases of anaphylactic reaction have been reported after Quadramet administration.
Croatian: Nakon primjene Quadrameta opisane su reakcije preosjetljivosti uključujući rijetke slučajeve anafilaktičnih reakcija.
English: 15 ml colourless European Pharmacopoeia Type I drawn glass vial closed with Teflon-coated chlorobutyl/natural rubber stopper and aluminium flip-off overseal.
Croatian: I prema Europskoj farmakopeji, volumena 15 ml, zatvorenoj teflonom obloženim čepom od klorbutilne/prirodne gume i aluminijskim "flipp-off" zatvaračem.
English: or similar phosphonates) or to any of the excipients excipients listed in section 6.1.
Croatian: ili neku od pomoćnih tvari navedenih u dijelu 6.1.
English: SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN Keep out of the sight and reach of children
Croatian: POSEBNO UPOZORENJE DA LIJEK TREBA ČUVATI IZVAN POGLEDA
English: F-91192 Gif-sur-Yvette cedex France
Croatian: F-91192 Gif-sur-Yvette Cedex Francuska
English: Each vial contains 1.5 ml (2 GBq at calibration) to 3.1 ml (4 GBq at calibration) of solution for injection.
Croatian: Jedna bočica sadrži 1,5 ml (2 GBq u vrijeme kalibracije) do 3,1 ml (4 GBq u vrijeme kalibracije) otopine za injekciju.
English: TABLE 1 : SAMARIUM-153 PRINCIPAL RADIATION EMISSION DATA Radiation
Croatian: TABLICA 1: PODACI O GLAVNIM VRSTAMA EMISIJE ZRAČENJA KOJE NASTAJU RASPADOM SAMARIJA-153
English: Please refer to the SmPC (SmPC should be included in the box)
Croatian: Molimo pogledajte Sažetak opisa svojstava lijeka (mora se nalaziti u kutiji).
English: Quadramet expires 1 day from the activity reference time stated on the label.
Croatian: Rok valjanosti Quadrameta ističe 1 dan od referentnog datuma navedenog na pakovanju.
English: 1 day from the activity reference time stated on the label.
Croatian: 1 dan od referentnog datuma navedenog na pakovanju.
English: Storage procedures should be in accordance with local regulations for radioactive substances.
Croatian: Postupci čuvanja moraju biti sukladni lokalnim propisima o radioaktivnim tvarima.
English: Postmarketing reports of thrombocytopenia have included isolated reports of intracranial haemorrhage, and cases in which the outcome was fatal.
Croatian: Izvješća o trombocitopeniji, pristigla nakon puštanja lijeka u promet, odnose se na izolirane slučajeve intrakranijalnog krvarenja, i slučajeve sa smrtnim ishodom.
English: • in patients having received chemotherapy or hemi-body external radiation therapy in a preceding period of 6 weeks.
Croatian: • bolesnici koji su primili kemoterapiju ili radioterapiju polovice tijela u razdoblju unazad 6
English: Because of the potential for additive effects on bone marrow, the treatment should not be given concurrently with chemotherapy or external beam radiation therapy.
Croatian: Zbog potencijalnog sinergističnog učinka na koštanu srž, ovaj se lijek ne smije primjenjivati istovremeno s kemoterapijom ili radioterapijom.
English: Storage procedures should be in accordance with national regulations for radioactive materials.
Croatian: Postupci čuvanja moraju biti sukladni nacionalnim propisima o radioaktivnim tvarima.
English: How to take Quadramet
Croatian: Kako primijenjivati Quadramet
English: Marketing authorisation holder and manufacturer
Croatian: Nositelj odobrenja za stavljanje gotovog lijeka u promet i proizvoñač
English: Once injected it concentrates in bone lesions.
Croatian: Nakon ubrizgavanja, koncentrira se u koštanim promjenama.
English: Your doctor will want to carry out a special scan before administering Quadramet to ascertain whether you are likely to benefit from Quadramet.
Croatian: Vaš će liječnik obaviti posebno snimanje kako bi utvrdio hoćete li imati od njega koristi.