FrancophonIA/ELRC3.0 huggingface dataset:
English: In the postmarketing setting, experience was gained in patients who initiated treatment at a dose of 1 mg/kg every 2 weeks and subsequently received a reduced dose for an extended period.
Croatian: 1 mg/kg svaka 2 tjedna, a nakon toga su dulje vrijeme primali smanjenu dozu.
English: Anaphylactoid reactions have been reported in the postmarketing setting.
Croatian: Nakon stavljanja lijeka u promet prijavljene su anafilaktičke reakcije.
English: - Necessary skills have to be acquired by non-healthcare professionals before Fabrazyme may be safely and effectively administered at home. - Their prescribing physician will provide training on the following elements: - That it is essential to follow strictly the prescribed dose and infusion rate - Method of preparation and administration of Fabrazyme - Instructions in handling possible adverse events - Instruction to seek emergency treatment by healthcare professionals in the event of any adverse reactions during an infusion
Croatian: - način pripreme i primjene lijeka Fabrazyme - upute za postupanje u slučaju mogućih nuspojava - bolesnika treba uputiti da potraži hitnu medicinsku pomoć u slučaju pojave nuspojava tijekom primjene infuzije
English: • rhinitis
Croatian: • nesvjestica
English: • upper respiratory tract congestion
Croatian: • opstrukcija gornjeg dijela dišnog sustava
English: Package leaflet: Information for the user Fabrazyme 5 mg powder for concentrate for solution for infusion
Croatian: Uputa o lijeku: Informacije za korisnika Fabrazyme 5 mg prašak za koncentrat za otopinu za infuziju agalzidaza beta
English: • musculoskeletal pain
Croatian: • ukočenost mišića i kostiju
English: Package leaflet: Information for the user Fabrazyme 35 mg powder for concentrate for solution for infusion
Croatian: Uputa o lijeku: Informacije za korisnika Fabrazyme 35 mg prašak za koncentrat za otopinu za infuziju agalzidaza beta
English: The level of support required for home infusion will be discussed and agreed by the patient and/or caregiver with the prescribing physician.
Croatian: Liječnik propisivač u dogovoru s bolesnikom i/ili njegovateljem određuje razinu potpore nužnu za primjenu infuzije kod kuće.
English: Agalsidase beta clearance was not influenced by weight in this population.
Croatian: U toj populaciji tjelesna težina nije utjecala na klirens agalzidaze beta.
English: Vascular disorders flushing, hypertension, pallor, hypotension, hot flush peripheral coldness --
Croatian: tahipneju, piskanje pri disanju, hipertenziju, hipotenziju, tahikardiju, palpitacije, bol u abdomenu,
English: 1 vial of powder for concentrate for solution for infusion.
Croatian: 1 bočica s praškom za koncentrat za otopinu za infuziju.
English: • nasopharyngitis
Croatian: • grlobolja
English: • dizziness
Croatian: • bljedilo
English: The reconstituted solution contains 5 mg agalsidase beta per ml, and appears as a clear colourless solution.
Croatian: Rekonstituirana otopina je bistra, bezbojna otopina koja sadrži 5 mg agalzidaze beta po ml. pH vrijednost rekonstituirane otopine je otprilike 7,0.
English: • throat pain
Croatian: • bol u prsima
English: • malaise
Croatian: • vrtoglavica
English: • lethargy
Croatian: • proljev
English: • Summary of Product Characteristics and Package Leaflet
Croatian: • Sažetak opisa svojstava lijeka i Uputu o lijeku
English: Excipients: mannitol sodium phosphate monobasic, monohydrate sodium phosphate dibasic, heptahydrate See the leaflet for further information.
Croatian: Drugi sastojci su: manitol natrijev dihidrogenfosfat hidrat natrijev hidrogenfosfat heptahidrat
English: Genzyme Europe B.V.- NL Store in a refrigerator (2°C - 8°C)
Croatian: POSEBNE MJERE ČUVANJA Čuvati u hladnjaku (2°C - 8°C).
English: • redness
Croatian: • svrbež
English: • abdominal discomfort
Croatian: • prekomjerno suzenje
English: Elderly
Croatian: Trudnoća
English: • chest discomfort
Croatian: • bezvoljnost
English: Both cases resolved.
Croatian: Oba su slučaja bila uspješno riješena.
English: Older people (≥ 65 years)
Croatian: Starije osobe(≥ 65 godina)
English: This process is called remodelling.
Croatian: Taj se proces naziva preoblikovanje.
English: - if you are pregnant.
Croatian: - ako ste trudni. - ako dojite.
English: Ελλάδα Teva Ελλάς Α.Ε.
Croatian: Teva Ελλάς Α.Ε.
English: • Key signs and symptoms of serious adverse events
Croatian: • Ključni znakovi i simptomi ozbiljnih štetnih događaja
English: The infusion must be conducted according to standard medical practice.
Croatian: Infuzija se mora provoditi u skladu sa standardnom medicinskom praksom.
English: Tell your dentist immediately if you experience such symptoms.
Croatian: Odmah se obratite svom zubaru ako primijetite takve simptome.
English: The duration of the trial was one year.
Croatian: Ispitivanje je trajalo godinu dana.
English: Mutagenicity and carcinogenic potential
Croatian: Mutagenost i karcinogeni potencijal
English: The clinical relevance of these findings is unknown.
Croatian: Kliničko značenje tih nalaza nije poznato.
English: Read all of this leaflet carefully before you are given this medicine because it contains important information for you.
Croatian: Pažljivo pročitajte cijelu uputu prije nego što počnete primati ovaj lijek jer sadrži Vama važne podatke.
English: Clinical experience with acute overdose is limited.
Croatian: Klinička iskustva s akutnim predoziranjem su ograničena.
English: Check with your doctor or nurse if you are not sure.
Croatian: Provjerite sa svojim liječnikom ili medicinskom sestrom ako niste sigurni.
English: - Do not throw away any medicines via wastewater (or household waste).
Croatian: Nikada nemojte nikakve lijekove bacati u otpadne vode (ili kućni otpad).
English: - The unopened bottle does not require any special storage conditions.
Croatian: - Neotvorena bočica ne zahtijeva posebne uvjete čuvanja.
English: All clinical fractures were verified based on the radiographic and/or clinical evidence.
Croatian: Svi klinički prijelom bili su potvrđeni na osnovi radiološkog i/ili kliničkog dokaza.
English: Your doctor will let you know when to return for your next dose.
Croatian: Vaš će Vam liječnik objasniti kada trebate primiti sljedeću dozu.
English: Effect on height
Croatian: Učinak na visinu
English: Clinical efficacy in men
Croatian: Klinička djelotvornost u muškaraca
English: This corresponds to a 28% reduction in the risk of all cause mortality (p=0.01).
Croatian: To se podudara s 28% smanjenjem rizika za sve uzroke smrtnosti (p=0,01).
English: Patients who have received doses higher than those recommended should be carefully monitored.
Croatian: Bolesnike koji su primali doze više od preporučenih potrebno je pažljivo pratiti.
English: Your doctor will inform you regarding the symptoms associated with hypocalcaemia.
Croatian: Liječnik će Vas upoznati sa simptomima koji su povezani s hipokalcijemijom.
English: - After opening the bottle, the product should be used immediately in order to avoid microbial contamination.
Croatian: - Nakon otvaranja bočice, lijek treba odmah primijeniti kako bi se izbjeglo mikrobiološko onečišćenje.
English: Follow carefully all instructions given to you by your doctor or nurse.
Croatian: Pažljivo slijedite sve upute koje Vam je dao liječnik ili medicinska sestra.
English: The infusion will take at least 15 minutes.
Croatian: Infuzija traje najmanje 15 minuta.
English: No symptomatic cases of hypocalcaemia were observed.
Croatian: Nisu opaženi simptomatski slučajevi hipokalcijemije.
English: It is important that you follow this advice carefully so that the level of calcium in your blood does not become too low in the period after the infusion.
Croatian: Važno je da se pažljivo pridržavate tog savjeta kako razina kalcija u krvi ne bi postala preniska u razdoblju nakon primjene infuzije.
English: The frequency of hypocalcaemia was much lower following subsequent infusions.
Croatian: Učestalost hipokalcijemije bila je znatno niža nakon daljnjih infuzija.
English: Class effects:
Croatian: Učinci klase:
English: 2100 Gödöllő
Croatian: 2100 Gödöllő Mađarska
English: A summary of results is presented in Table 3.
Croatian: Sažetak rezultata prikazan je u Tablici 3.
English: Zoledronic acid Teva Generics may work for longer than one year, and your doctor will let you know if you need to be treated again.
Croatian: Zoledronatna kiselina Teva Generics može djelovati duže od godinu dana, a liječnik će Vam reći ako se trebate ponovo liječiti.
English: • When to seek attention from the health care provider
Croatian: • Kada zatražiti pomoć zdravstvenog djelatnika
English: Limited data on re-treatment of Paget's disease are available (see section 5.1).
Croatian: Dostupni su samo ograničeni podaci o ponovnom liječenje Pagetove bolesti (vidjeti dio 5.1).
English: This is especially important in patients who take diuretics (“water pills”) and in elderly patients.
Croatian: To je osobito važno u bolesnika koji uzimaju diuretike („tablete za mokrenje“) i u starijih bolesnika.
English: For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Croatian: Za sve infromacije o ovom lijeku obratite se lokalnom predstavniku nositelja odobrenja za stavljanje u promet gotovog lijeka:
English: • Need for adequate calcium and vitamin D supplementation, appropriate physical activity, non smoking and healthy diet
Croatian: • Potreba za primjerenim nadomještanjem kalcija i vitamina D, primjerenom fizičkom aktivnošću, nepušenjem i zdravom prehranom
English: Table 1 Infections and infestations
Croatian: Tablica 1. Infekcije i infestacije
English: Poor healing of these fractures has also been reported.
Croatian: Također je zabilježeno slabo zacjeljivanje tih prijeloma.
English: EXP After opening: 24 hours at 2°C - 8°C
Croatian: Nakon otvaranja: 24 sata na 2°C - 8°C
English: ** Based on post-marketing reports.
Croatian: ** Temeljeno na izvješćima poslije stavljanja u promet.
English: No dose adjustment is necessary since bioavailability, distribution and elimination were similar in elderly patients and younger subjects.
Croatian: Dozu nije potrebno prilagođavati jer su bioraspoloživost, distribucija i eliminacija bili slični u starijih bolesnika i mlađih ispitanika.
English: In the HORIZON-RFT study 508 men were randomised into the study and 185 patients had BMD assessed at 24 months.
Croatian: U ispitivanju HORIZON-RFT randomizirano je 508 muškaraca i u 185 bolesnika BMD je bio procijenjen nakon 24 mjeseca.
English: Zoledronic acid was evaluated in rats for potential adverse effects on fertility of the parental and F1 generation.
Croatian: Zoledronatna kiselina bila je proučavana u štakora zbog potencijalnih štetnih učinaka na plodnost roditeljske i F1 generacije.
English: At the menopause, a woman's ovaries stop producing the female hormone oestrogen, which helps keep bones healthy.
Croatian: U menopauzi ženski jajnici prestaju stvarati ženski hormon estrogen koji pomaže u održavanju zdravih kostiju.
English: Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Croatian: Unutar svake skupine učestalosti, nuspojave su poredane prema padajućoj ozbiljnosti.
English: - if you have hypocalcaemia (this means that the levels of calcium in your blood are too low).
Croatian: - ako imate hipokalcijemiju (što znači da imate prenisku razinu kalcija u krvi).
English: The physician educational material should contain the following key elements:
Croatian: Edukativni materijali za liječnika trebaju sadržavati sljedeće ključne elemente:
English: These could be signs of bone damage in the jaw (osteonecrosis).
Croatian: To bi mogli biti znakovi oštećenja kostiju u čeljusti (osteonekroze).
English: Hypocalcaemia* Uncommon Anorexia, decreased appetite
Croatian: Hipokalcijemija * Manje često Anoreksija, smanjen apetit
English: The majority of patients continued to receive glucocorticoids for the one year duration of the trial.
Croatian: Većina bolesnika nastavila je primati glukokortikoide tijekom godine dana trajanja ispitivanja.
English: The total body clearance is 5.04 ± 2.5 l/h, independent of dose, and unaffected by gender, age, race or body weight.
Croatian: Ukupni klirens iz organizma je 5,04 ± 2,5 l/sat, neovisno o dozi i bez obzira na spol, dob, rasu i tjelesnu težinu.
English: At least one new vertebral fracture (0-1 year) At least one new vertebral fracture (0-2 year) At least one new vertebral fracture (0-3 year) ** p <0.0001
Croatian: Najmanje jedan novi vertebralni prijelom (0-1 godina) Najmanje jedan novi vertebralni prijelom (0-2 godine) Najmanje jedan novi vertebralni prijelom (0-3 godine) ** p <0,0001
English: Osteoporosis could also occur in men and women because of the long term use of steroids, which can affect the strength of bones.
Croatian: Osteoporoza se također može pojaviti u muškaraca i žena zbog dugotrajnog korištenja steroida koji utječu na čvrstoću kostiju.
English: Your doctor can recommend a mild pain reliever such as ibuprofen or paracetamol to reduce these side effects.
Croatian: Vaš liječnik će Vam preporučiti blagi lijek protiv bolova, poput ibuprofena ili paracetamola, kako bi se smanjile ove nuspojave.
English: It is especially important for your doctor to know all the medicines you are taking, especially if you are taking any medicines known to be harmful to your kidneys (e.g. aminoglycosides) or diuretics (“waterpills”) that may cause dehydration.
Croatian: Osobito je važno da Vaš liječnik zna za sve lijekove koje uzimate, naročito ako uzimate lijekove za koje je poznato da štetno djeluju na bubrege (npr. aminoglikozidi) ili ako uzimate diuretike (“tablete za mokrenje”) koji mogu uzrokovati dehidraciju.
English: Side effects related to the first infusion are very common (occurring in more than 30% of patients) but are less common following subsequent infusions.
Croatian: Nuspojave povezane s prvom infuzijom su vrlo česte (javljaju se u više od 30% bolesnika), ali su znatno rjeđe nakon daljnjih infuzija.
English: Many of these patients had signs of local infection including osteomyelitis, and the majority of the reports refer to cancer patients following tooth extractions or other dental surgeries.
Croatian: Mnogi od tih bolesnika imali su znakove lokalne infekcije uključujući osteomijelitis, a većina izvješća odnosi se na bolesnike s rakom nakon vađenja zubi ili drugih stomatoloških operacija.
English: If you feel dizzy while taking Zoledronic acid Teva Generics, do not drive or use machines until you feel better.
Croatian: Ako osjećate omaglicu dok uzimate Zoledronatnu kiselinu Teva Generics, nemojte upravljati vozilima ili strojevima dok se ne budete osjećali bolje.
English: Pharmachemie B.V. Swensweg 5
Croatian: Pharmachemie B.V. sweg 5
English: Repeat dosing did not lead to further reduction of bone turnover markers.
Croatian: Ponovljeno doziranje nije dovelo do dodatnog smanjenja markera koštane pregradnje.
English: Many patients with osteoporosis have no symptoms but they are still at risk of breaking bones because osteoporosis has made their bones weaker.
Croatian: Mnogi bolesnici s osteoporozom nemaju simptome, ali su svejedno izloženi riziku od loma kostiju jer je osteoporoza oslabila njihove kosti.
English: Histomorphometric analysis showed a 63% reduction in bone turnover.
Croatian: Histomorfometrijska analiza pokazala je smanjenje koštane pregradnje od 63%.
English: It is normal that old bone is removed and is replaced with new bone material.
Croatian: Normalno je da se stara kost razgrađuje i da se obnavlja novim koštanim tkivom.
English: Thus these results precluded determining a definitive effect of zoledronic acid on fertility in humans.
Croatian: Stoga su ti rezultati spriječili utvrđivanje definitivnog učinka zoledronatne kiseline na plodnost u ljudi.
English: The symptoms are usually mild to moderate and go away within three days.
Croatian: Simptomi su obično blagi do umjereno teški i nestaju unutar tri dana.
English: Not known** Osteonecrosis of the jaw (see sections 4.4 and 4.8 Class effects)
Croatian: Nije poznato** Osteonekroza čeljusti (vidjeti dijelove 4.4 i 4.8 Učinci klase)
English: Physicians should consider clinical monitoring for these patients.
Croatian: Liječnici moraju procijeniti potrebu za kliničkim praćenjem u tih bolesnika.
English: - if you have severe kidney problems.
Croatian: - ako imate teških problema s bubrezima.
English: These results were consistent with biochemical marker evidence of normalisation of bone turnover.
Croatian: Ti su rezultati bili u skladu s biokemijskim markerima koji su pokazali normalizaciju koštane pregradnje.
English: Placebo (N = 1,062) event rate
Croatian: Placebo (N=1062) stopa događaja
English: This is especially important for the elderly and for patients receiving diuretic therapy.
Croatian: To je osobito važno za starije osobe i bolesnike koji primaju diuretsku terapiju.
English: The primary efficacy variable was the incidence of clinical fractures over the duration of the study.
Croatian: Primarna varijabla djelotvornosti bila je incidencija kliničkih prijeloma tijekom trajanja ispitivanja.
English: Uncommon (may affect up to 1 in 100 people) Skin reactions such as redness.
Croatian: Manje često (mogu se javiti u do 1 na 100 osoba) Kožne reakcije poput crvenila.
English: The patient information pack should be provided and contain the following key messages:
Croatian: Potrebno je napraviti informativni paket za bolesnika u kojem će biti navedene sljedeće ključne poruke:
English: Danmark Teva Denmark A/S Tlf: +45 44 98 55 11
Croatian: Teva Denmark A/S Tlf: +45 44 98 55 11
English: During this entire time period bone turnover markers were within the pre-menopausal range at the end of each year.
Croatian: Tijekom čitavog razdoblja markeri koštane pregradnje bili su unutar premenopauzalnog raspona na kraju svake godine.
English: Patients should be informed about symptoms of hypocalcaemia and receive adequate clinical monitoring during the period of risk.
Croatian: Bolesnike je potrebno obavijestiti o simptomima hipokalcijemije te ih tijekom razdoblja rizika odgovarajuće klinički pratiti.
English: If you experience any of the above side effects, you should contact your doctor immediately.
Croatian: Ako primijetite bilo koju od navedenih nuspojava, odmah se obratite svom liječniku.
English: As with other bisphosphonates, the retention time of zoledronic acid in bones is very long.
Croatian: Kao i u slučaju ostalih bisfosfonata, vrijeme zadržavanja zoledronatne kiseline u kostima je vrlo dugo.
English: Gödöllő 2100
Croatian: Gödöllő 2100 Mađarska
English: Effect on all clinical fractures
Croatian: Učinak na sve kliničke prijelome
English: These transverse or short oblique fractures can occur anywhere along the femur from just below the lesser trochanter to just above the supracondylar flare.
Croatian: Ti poprečni ili kratki kosi prijelomi mogu nastati bilo gdje na bedrenoj kosti, od neposredno ispod malog trohantera do neposredno iznad suprakondilarnog dijela.
English: • Monitoring of serum creatinine should be considered in at-risk patients.
Croatian: • Praćenje kreatinina u serumu potrebno je uzeti u obzir u bolesnika s rizikom.
English: In Paget's disease, bone remodelling is too rapid and new bone is formed in a disordered fashion, which makes it weaker than normal.
Croatian: Kod Pagetove bolesti, preoblikovanje kosti je prebrzo te se nova kost stvara na poremećen način, čime postaje slabija nego normalno.
English: INFORMATION FOR THE HEALTHCARE PROFESSIONAL
Croatian: INFORMACIJE ZA ZDRAVSTVENE DJELATNIKE
English: • Transient increase in serum creatinine may be greater in patients with underlying impaired renal function.
Croatian: • Prolazni porast kreatinina u serumu može biti veći u bolesnika koji imaju predležeću oštećenu funkciju bubrega.
English: Other disturbances of mineral metabolism must also be effectively treated (e.g. diminished parathyroid reserve, intestinal calcium malabsorption).
Croatian: Ostali poremećaji metabolizma minerala također se moraju učinkovito liječiti (npr. smanjenje zalihe paratireoidnih žlijezda, intestinalna malapsorpcija kalcija).
English: Following the menopause bone loss occurs, bones become weaker and break more easily.
Croatian: Nakon menopauze dolazi do gubitka kosti, kosti postaju slabije i lakše se lome.
English: Increasing the infusion time from 5 to 15 minutes caused a 30% decrease in zoledronic acid concentration at the end of the infusion, but had no effect on the area under the plasma concentration versus time curve.
Croatian: Povećanje vremena infuzije sa 5 na 15 minuta uzrokovalo je 30% smanjenje koncentracije zoledronatne kiseline na kraju infuzije, ali nije imalo učinka na površinu ispod krivulje plazmatske koncentracije u odnosu na vrijeme.
English: While on treatment, these patients should avoid invasive dental procedures if possible.
Croatian: Ako je moguće, ovi bolesnici moraju izbjegavati invazivne stomatološke zahvate tijekom liječenja.
English: The study was not designed to measure significant differences in hip fracture, but a trend was seen towards reduction in new hip fractures.
Croatian: Ispitivanje nije bilo osmišljeno tako da mjeri značajne razlike prijeloma kuka, ali je zapažen trend smanjenja novih prijeloma kuka.
English: There was no accumulation of the active substance in plasma after multiple doses given every 28 days.
Croatian: Nije bilo nakupljanja zoledronatne kiseline u plazmi nakon višestrukih doza lijeka davanih svakih 28 dana.
English: The need for continued treatment should be re-evaluated periodically based on the benefits and potential risks of zoledronic acid on an individual patient basis, particularly after 5 or more years of use.
Croatian: Potrebu za nastavkom liječenja potrebno je ponovno procijeniti periodički na osnovi odnosa koristi i potencijalnih rizika zoledronatne kiseline u svakog pojedinačnog bolesnika, a posebno nakon 5 ili više godina primjene.
English: Bone biopsy results showed bone of normal quality with no evidence of impaired bone remodelling and no evidence of mineralisation defects.
Croatian: Rezultati biopsije kosti pokazali su kost normalne kvalitete, bez znakova oštećenog remodeliranja kosti kao i bez dokaza o mineralizacijskim defektima.
English: The early disposition phases (α and β, with t½ values above) presumably represent rapid uptake into bone and excretion via the kidneys.
Croatian: Rane faze dispozicije (α i β, s prije navedenim t½ vrijednostima) vjerojatno predstavljaju brz koštani unos i izlučivanje putem bubrega.
English: Swelling, redness, pain and itching to the eyes or eye sensitivity to light.
Croatian: Oticanje, crvenilo, bol i svrbež očiju ili osjetljivost očiju na svjetlost.
English: Paget's disease
Croatian: Pagetova bolest
English: Any clinical fracture (1)
Croatian: Bilo koji klinički prijelom (1)
English: Effect on bone mineral density (BMD)
Croatian: Učinci na mineralnu gustoću kosti (BMD)
English: Decreased circulating levels of sex hormones, mainly oestrogens converted from androgens, also play a role in the more gradual bone loss observed in men.
Croatian: Sniženje razine spolnih hormona u cirkulaciji, prvenstveno estrogena koji su nastali od androgena, također ima ulogu u postupnijem gubitku kosti zamijećenom u muškaraca.
English: This uptake into bone is common for all bisphosphonates and is presumably a consequence of the structural analogy to pyrophosphate.
Croatian: Taj je unos u koštano tkivo zajednički za sve bisfosfonate i vjerojatno je posljedica strukturalne analogije s pirofosfatima.
English: All cause mortality was 10% (101 patients) in the zoledronic acid-treated group compared to 13% (141 patients) in the placebo group.
Croatian: Smrtnost zbog svih uzroka bila je 10% (101 bolesnik) u skupini liječenih zoledronatnom kiselinom u usporedbi s 13% (141 bolesnik) u placebo skupini.
English: For patients who develop osteonecrosis of the jaw while on bisphosphonate therapy, dental surgery may exacerbate the condition.
Croatian: U bolesnika koji razviju osteonekrozu čeljusti tijekom liječenja bisfosfonatima, stomatološka operacija mogla bi pogoršati stanje.
English: It is an inhibitor of osteoclast-mediated bone resorption.
Croatian: Ona je inhibitor osteoklastične resorpcije kosti.