FrancophonIA/ELRC3.0 huggingface dataset:
English: It is recommended that you take OSSEOR in-between meals, preferably at bedtime at least two hours after food, milk or milk products or calcium supplements.
Croatian: Preporučuje se da OSSEOR uzimate između obroka, po mogućnosti u vrijeme odlaska na spavanje, najmanje dva sata nakon jela, obroka mlijeka, mliječnih proizvoda ili nakon uzimanja dodataka kalcija.
English: Pharmacotherapeutic group: Drugs for the treatment of bone diseases - Other drugs affecting bone structure and mineralisation, ATC code: M05BX03
Croatian: Farmakoterapijska skupina: Lijekovi za liječenje bolesti kostiju - ostali lijekovi koji utječu na građu i mineralizaciju kosti, ATK oznaka: M05BX03
English: • The patient alert card should be given to every patient.
Croatian: • Kartica s upozorenjima za bolesnike treba se dati svakom bolesniku.
English: Although in-use studies have demonstrated that strontium ranelate is stable in suspension for 24 hours after preparation, the suspension should be drunk immediately after being prepared.
Croatian: Premda su ispitivanja lijeka u primjeni pokazala da je stroncijev ranelat u suspenziji stabilan 24 sata nakon priprave, suspenziju se mora popiti odmah nakon njene priprave.
English: - if you have or have had problems with your blood circulation (peripheral arterial disease) or if you have had surgery on the arteries of your legs.
Croatian: - ako imate ili ste imali problema s cirkulacijom (periferna arterijska bolest) ili ste imali operaciju arterija Vaših nogu.
English: The risk of vein thrombosis (blood clots in the leg or lungs) may be increased in the event of lengthy immobilisation.
Croatian: Rizik od razvoja venske tromboze (krvni ugrušci u nozi ili plućima) se može povećati u slučaju dužeg mirovanja.
English: Strontium ranelate does not inhibit cytochrome P450 enzymes.
Croatian: Stroncijev ranelat ne inhibira enzime citokroma P450.
English: Do not take a double dose to make up for forgotten individual doses.
Croatian: Nemojte uzeti dvostruku dozu da nadomjestite onu propuštenu.
English: There were no differences in the nature of adverse reactions between treatment groups regardless of whether patients were aged below or above 80 at inclusion.
Croatian: Nije bilo razlike u prirodi nuspojava između grupa bez obzira da li su bolesnici prilikom uključivanja u ispitivanju bili mlađi ili stariji od 80 godina.
English: Therapy should not be restarted until the initiating condition has resolved and the patient is fully mobile.
Croatian: Terapija se ne smije opet nastaviti ukoliko takvo stanje nije u potpunosti izliječeno i dok bolesnik nije opet potpuno pokretan.
English: Due to the nature of the treated disease, strontium ranelate is intended for long-term use.
Croatian: Zbog naravi bolesti koja se liječi, stroncijev ranelat je namijenjen dugotrajnoj primjeni.
English: Excipient with known effect: Each sachet also contains 20 mg of aspartame (E951).
Croatian: Pomoćna tvar s poznatim učinkom: Jedna vrećica sadrži i 20 mg aspartama (E951).
English: Strontium ranelate is made up of 2 atoms of stable strontium and 1 molecule of ranelic acid, the organic part permitting the best compromise in terms of molecular weight, pharmacokinetics and acceptability of the medicinal product.
Croatian: Stroncijev se ranelat sastoji od 2 atoma stabilnog stroncija i 1 molekule ranelatne kiseline, koja čini organski dio molekule, što predstavlja najbolji kompromis s obzirom na molekulsku težinu, farmakokinetiku i prihvatljivost lijeka.
English: Strontium ranelate does not present a risk for the environment.
Croatian: Stroncijev ranelat ne predstavlja opasnost za okolinu.
English: They may advise you to drink milk or take antacids to reduce the absorption of the active ingredient.
Croatian: Možda će Vam savjetovati da pijete mlijeko ili uzmete antacide, kako biste smanjili apsorpciju djelatnog sastojka.
English: The MAH shall ensure that, following discussion and agreement with the National Competent Authority in each Member State where OSSEOR is marketed, all physicians who are expected to prescribe OSSEOR are provided with the following educational package:
Croatian: Nositelj odobrenja će osigurati da, nakon rasprave i dogovora sa nacionalnim nadležnim tijelom svake države članice gdje je OSSEOR prisutan na tržištu, svi liječnici za koje se očekuje da će propisivati
English: The decision to prescribe strontium ranelate should be based on an assessment of the individual patient's overall risks (see sections 4.3 and 4.4).
Croatian: Odluka o propisivanju stroncijevog ranelata mora se temeljiti na procjeni ukupnog individualnog rizika za bolesnika (vidjeti dijelove 4.3 i 4.4).
English: Signs of a blood clot include painful swelling in your leg, sudden chest pain or difficulty breathing.
Croatian: Znakovi krvnog ugruška uključuju bolno oticanje noge, iznenadnu bol u prsnom košu ili otežano disanje.
English: Excipient OSSEOR contains a source of phenylalanine, which may be harmful for people with phenylketonuria.
Croatian: Pomoćna tvar OSSEOR sadržava izvor fenilalanina, koji može biti štetan za osobe s fenilketonurijom.
English: If you have stopped treatment due to hypersensitivity reactions, do not take OSSEOR again
Croatian: Ukoliko ste prestali uzimati lijek zbog reakcija preosjetljivosti, ne smijete ponovo započeti uzimanje
English: Additional signs to look for include ulcers in the mouth, throat, nose, genitals and conjunctivitis (red and swollen eyes).
Croatian: Dodatnim znakovi na koje treba obratiti pažnju su vrijed u ustima, grlu, nosu, spolovilu i konjunktivitis (crvene i otečene oči).
English: INFORMATION IN BRAILLE OSSEOR 2 g
Croatian: 16. PODACI NA BRAILLEOVOM PISMU OSSEOR 2 g
English: The treatment should only be started by a doctor with experience of treating osteoporosis.
Croatian: Liječenje treba započeti samo liječnik s iskustvom u liječenju osteoporoze.
English: There is no accumulation of ranelic acid and no evidence of metabolism in animals and humans.
Croatian: Ranelatna se kiselina ne nakuplja i nema dokaza o njenu metabolizmu ni u životinja ni u čovjeka.
English: No dose adjustment is required in relation to age.
Croatian: Dozu s obzirom na dob ne treba prilagođavati.
English: Osteoporosis is defined as BMD of the spine or hip 2.5 SD or more below the mean value of a normal young population.
Croatian: Osteoporoza se definira kao BMD kralješnice ili kuka koja je za 2,5 SD niža, ili još niža od srednje vrijednosti u zdrave, mlade populacije.
English: When treating patients over 80 years at risk of VTE, the need for continued treatment with OSSEOR should be re-evaluated.
Croatian: Pri liječenju bolesnika starijih od 80 godina s rizikom od VTE, potrebno je preispitati nastavak liječenja s OSSEOR-om.
English: If you have osteoporosis, your body breaks down more bone than it forms so that gradually bone loss occurs and your bones become thinner and fragile.
Croatian: Ako imate osteoporozu, Vaše tijelo razgrađuje više koštanog tkiva nego što proizvede novog, što znači da se koštano tkivo postupno gubi, tako da kosti postaju tanje i krhke.
English: Early withdrawal is associated with a better prognosis.
Croatian: Što raniji prestanak primjene suspektnog lijeka je povezan s boljom prognozom.
English: The European Medicines Agency has waived the obligation to submit the results of studies with OSSEOR in all subsets of the paediatric population in osteoporosis (see section 4.2 for information on paediatric use).
Croatian: Europska agencija za lijekove je izuzela obvezu podnošenja rezultata ispitivanja OSSEOR-a u svim podskupinama pedijatrijske populacije u osteoporozi (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
English: The absolute bioavailability of strontium is about 25% (range 19-27%) after an oral dose of 2 g strontium ranelate.
Croatian: Apsolutna bioraspoloživost stroncija iznosi oko 25 % (raspon: 19-27 %) nakon peroralne doze od 2 g stroncijeva ranelata.
English: - The other ingredients are aspartame (E 951), maltodextrin, mannitol (E 421).
Croatian: - Pomoćne tvari su: aspartam (E951), maltodekstrin i manitol (E 421).
English: The pharmacokinetics of strontium and ranelic acid have been assessed in healthy young men and healthy postmenopausal women, as well as during long-term exposure in men with osteoporosis and postmenopausal osteoporotic women including elderly women.
Croatian: Farmakokinetika stroncija i ranelatne kiseline bile su procijenjene u zdravih mladih muškaraca i u zdravih žena u poslijemenopauzi, kao i pri dugotrajnoj izloženosti u muškaraca s osteoporozom i u žena u poslijemenopauzi s osteoporozom, uključivši starije žene.
English: Mean age was 75 years at inclusion and 23% of the patients enrolled were 80 to 100 years of age.
Croatian: 23% uključenih bolesnica bilo je u dobi od 80 do 100 godina.
English: • Prescriber guide and checklist
Croatian: • Uputu za propisivača i listu provjere
English: Fertility No effects were observed on males and females fertility in animal studies.
Croatian: Plodnost Nisu uočeni učinci na plodnost mužjaka i ženki u istraživanjima na životinjama.
English: Recovery could be slow and recurrences of the syndrome have been reported in some cases after discontinuation of corticosteroid therapy.
Croatian: Oporavak može biti spor te je nekim slučajevima zabilježeno ponovno javljanje sindroma po prestanku kortikosteroidne terapije.
English: Given the slow absorption, OSSEOR should be taken at bedtime, preferably at least two hours after eating (see sections 4.5 and 5.2).
Croatian: Imajući u vidu sporu apsorpciju, OSSEOR treba uzimati u vrijeme odlaska na spavanje, po mogućnosti najmanje dva sata nakon jela (vidjeti dijelove 4.5 i 5.2).
English: The highest risk for occurrence of SJS or TEN is within the first weeks of treatment and usually around 36 weeks for DRESS
Croatian: Najveći rizik od pojave SJS ili TEN je unutar prvih tjedana liječenja, a za DRESS obično oko 3-6 tjedana.
English: Treatment of Osteoporosis in men:
Croatian: Liječenje osteoporoze u muškaraca:
English: Therefore, administration of OSSEOR and such products should be separated by at least two hours (see section 5.2).
Croatian: Stoga razmak između uzimanja OSSEOR-a i tih proizvoda mora iznositi najmanje dva sata (vidjeti dio 5.2)
English: The clinical consequence of osteoporosis is fractures.
Croatian: Klinička posljedica osteoporoze je pojava prijeloma.
English: Oral supplementation with vitamin D has no effect on strontium exposure.
Croatian: Dodaci vitamina D za peroralnu primjenu ne utječu na izloženost stronciju.
English: The most common adverse reactions consisted of nausea and diarrhoea, which were generally reported at the beginning of treatment with no noticeable difference between groups afterwards.
Croatian: Najčešće nuspojave bile su mučnina i proljev, a općenito su se javljale na početku terapije, te među skupinama nije bilo uočljivih razlika.
English: Quality of life assessment on the QUALIOST specific scale as well as the General Health perception score of the SF-36 general scale indicated benefit of OSSEOR, compared with placebo.
Croatian: Procjena kvalitete života specifičnom ljestvicom QUALIOST, kao i procjenom općeg zdravstvenog stanja (General Health perception score) ljestvicom SF-36 također je pokazala koristi OSSEOR-a u odnosu na placebo.
English: Food, milk and milk products reduce the absorption of strontium ranelate.
Croatian: Hrana, mlijeko i mliječni proizvodi smanjuju apsorpciju stroncijeva ranelata.
English: Population pharmacokinetic data showed no relationship between age and apparent clearance of strontium in the target population.
Croatian: Podaci o populacijskoj farmakokinetici nisu pokazali povezanost između dobi i prividnog klirensa stroncija u ciljnoj populaciji.
English: Percentage of Patients Experiencing the adverse reaction Treatment Strontium ranelate (n=3352)
Croatian: Postotak bolesnika koji su doživjeli nuspojavu Terapija Stroncijev ranelat (n=3352)
English: In accordance with good medical practice, periodic assessment of renal function is recommended in patients with chronic renal impairment.
Croatian: U skladu s dobrom medicinskom praksom, preporučuje se redovita kontrola bubrežne funkcije u osoba s kroničnim oštećenjem bubrega.
English: OSSEOR should be discontinued as soon as possible in the event of an illness or a condition leading to immobilisation (see section 4.3) and adequate preventive measures taken.
Croatian: Liječenje OSSEOR-om treba što je prije moguće prekinuti u slučaju bolesti ili stanja koje dovodi do imobilizacije (vidjeti dio 4.3) te provesti preventivne mjere.
English: How to take osseor
Croatian: Kako uzimati OSSEOR
English: As a precautionary measure, OSSEOR treatment should be suspended during treatment with oral tetracycline or quinolone antibiotics.
Croatian: Kao mjeru opreza, primjenu OSSEOR-a mora se obustaviti za vrijeme liječenja peroralnim tetraciklinskim ili kinolonskim antibioticima.
English: The binding of strontium to human plasma proteins is low (25%) and strontium has a high affinity for bone tissue.
Croatian: Stroncij se slabo veže na proteine plazme (25 %), a ima velik afinitet za koštano tkivo.
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu
Croatian: Detaljnije informacije o ovom lijeku dostupne su na web stranici Europske agencije za lijekove: http://www.ema.europa.eu
English: Absorbed ranelic acid is rapidly eliminated unchanged via the kidneys.
Croatian: Apsorbirana ranelatna kiselina se u nepromijenjenu obliku brzo eliminira putem bubrega.
English: Your doctor may advise you to take calcium and vitamin D supplements in addition to OSSEOR.
Croatian: Vaš će Vam liječnik možda savjetovati da uz OSSEOR uzimate i nadopunu kalcija i vitamina D.
English: If OSSEOR is used inadvertently during pregnancy, treatment must be stopped.
Croatian: OSSEOR nehotice u trudnoći, liječenje se mora obustaviti.
English: Strontium ranelate has no or negligible influence on the ability to drive and use machines.
Croatian: Stroncijev ranelat ne utječe ili utječe zanemarivo na sposobnost upravljanja vozilima i rada sa strojevima.
English: The frequency of possible side effects listed below is defined using the following convention: very common: may affect more than 1 in 10 people common: may affect 1 in 10 people uncommon: mayaffect 1 in 100 people rare: mayaffect up to 1 in 1,000 people very rare: may affect up to 1 in 10,000 people not known: frequency cannot be estimated from the available data
Croatian: vrlo često: mogu se pojaviti u više od 1 na 10 osoba često: mogu se pojaviti u do 1 na 10 osoba manje često: mogu se pojaviti u do 1 na 100 osoba rijetko: mogu se pojaviti u do 1 na 1000 osoba vrlo rijetko: mogu se pojaviti u do 1 na 10 000 osoba nepoznato: učestalost se ne može procijeniti iz dostupnih podataka
English: The marketing authorisation holder shall submit periodic safety update reports for this product in accordance with the requirements set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and published on the European medicines web-portal.
Croatian: Nositelj odobrenja će periodička izvješća o neškodljivosti za ovaj lijek podnositi u skladu s referentnim popisom datuma EU (EURD popis) predviđenim člankom 107(c) stavkom 7
English: Due to the relatively slow absorption of strontium, food and calcium intake should be avoided both before and after administration of OSSEOR.
Croatian: Zbog razmjerno spore apsorpcije stroncija, kalcij i hranu treba izbjegavati i prije i nakon uzimanja OSSEOR-a.
English: There are no data from the use of strontium ranelate in pregnant women.
Croatian: Nema podataka o primjeni stroncijeva ranelata u trudnica.
English: Continuation of treatment with OSSEOR in patients developing severe renal impairment should be considered on an individual basis.
Croatian: Nastavak terapije OSSEOR-om u bolesnika u kojih je nastupilo teško oštećenje bubrega mora se razmotriti na individualnoj osnovi.
English: Food, milk and derivative products, and medicinal products containing calcium may reduce the bioavailability of strontium ranelate by approximately 60-70%.
Croatian: Hrana, mlijeko i mliječni proizvodi te lijekovi koji sadržavaju kalcij mogu smanjiti bioraspoloživost stroncijeva ranelata za oko 60-70%.
English: Patients with significant risk factors for cardiovascular events (e.g. hypertension, hyperlipidaemia, diabetes mellitus, smoking) should only be treated with strontium ranelate after careful consideration (see sections 4.3 and 4.8).
Croatian: Bolesnici sa značajnim rizikom za razvoj kardiovaskularnih događaja (npr. hipertenzija, hiperlipidemija, dijabetes melitus, pušenje) smiju se liječiti stroncijevim ranelatom samo nakon pažljive procjene (vidjeti dijelove 4.3 i 4.8).
English: Developmental toxicity studies in rats and rabbits resulted in bone and tooth abnormalities (e.g. bent long bones and wavy ribs) in the offspring.
Croatian: Istraživanja razvojne toksičnosti u štakora i kunića otkrila su nenormalnosti kostiju i zuba (npr. savijene duge kosti i valovita rebra) u mladunčadi.
English: During OSSEOR treatment, these cardiovascular risks should be monitored on a regular basis generally every 6 to 12 months.
Croatian: Tijekom liječenja OSSEOR-om, ovi kardiovaskularni rizici trebaju se pratiti u redovitim intervalima, u pravilu svakih 6 do 12 mjeseci.
English: Available data indicate that these factors account for approximately 50% of the measured change in BMD over 3 years of treatment with OSSEOR 2 g/day.
Croatian: Dostupni podaci pokazuju da su ti čimbenici bili odgovorni za oko 50 % izmjerene promjene BMD tijekom 3 godine uzimanja OSSEOR-a u dozi od 2 g/dan.
English: Rare: Severe hypersensitivity reactions (DRESS: see section 2)
Croatian: Teške reakcije preosjetljivosti (DRESS: vidjeti dio.
English: - if you are immobilised permanently or for some time such as being wheel-chair bound, or confined to bed or if you are to undergo an operation or recovering from an operation.
Croatian: - ako ste trajno ili privremeno nepokretni tj. vezani za invalidska kolica ili krevet, ili ćete ići na operaciju ili se oporavljate od operacije.
English: This is especially common in women after the menopause.
Croatian: To se osobito često događa ženama u poslijemenopauzi.
English: The highest risk of occurrence of serious skin reactions is within the first weeks of treatment for Stevens-Johnson syndrome and toxic epidermal necrolysis and usually around 3-6 weeks for DRESS.
Croatian: Najveći rizik od pojave ozbiljnih kožnih reakcija je tijekom prvih tjedana liječenja za razvoj StevensJohnson-ov sindroma i toksične epidermalne nekrolize, i obično oko 3-6 tjedana za razvoj DRESS-a.
English: When a VTE occurs, OSSEOR should be stopped.
Croatian: Kada se pojavi VTE, OSSEOR treba odmah prestati uzimati.
English: As divalent cations can form complexes with oral tetracycline and quinolone antibiotics at the gastrointestinal level and thereby reduce their absorption, simultaneous administration of strontium ranelate with these medicinal products is not recommended.
Croatian: Budući da dvovalentni kationi mogu stvarati komplekse s peroralno uzetim tetraciklinskim i kinolonskim antibioticima na gastrointestinalnoj razini i time smanjiti njihovu apsorpciju, ne preporučuje se istodobna primjena stroncijeva ranelata i tih lijekova.
English: • OSSEOR is contraindicated and must not be used in patients with : o Established, current or past history of ischaemic heart disease, peripheral arterial disease and/or cerebrovascular disease.
Croatian: • OSSEOR je kontraindiciran i ne smije se koristiti u bolesnika s : o Dokazanom, postojećom ili prethodnom ishemijskom bolesti srca, perifernom arterijskom bolesti i/ili cerebrovaskularnom bolesti u anamnezi.
English: In addition to their treatment (2 g/day strontium ranelate or placebo), the patients received adapted calcium and vitamin D supplements throughout both studies.
Croatian: Uz liječenje (2 g/dan stroncijeva ranelata ili placebo), bolesnice su za trajanja oba ispitivanja primale prilagođenu nadopunu kalcija i vitamina D.
English: OSSEOR, which contains the substance strontium ranelate, belongs to a group of medicines used to treat bone diseases.
Croatian: Kako djeluje OSSEOR OSSEOR, koji sadrži djelatnu tvar stroncijev ranelat, pripada skupini lijekova koji se koriste za liječenje bolesti kostiju.
English: Chronic oral administration of strontium ranelate at high doses in rodents induced bone and tooth abnormalities, mainly consisting of spontaneous fractures and delayed mineralisation that were reversible after cessation of treatment.
Croatian: Kronična peroralna primjena velikih doza stroncijeva ranelata u glodavaca je izazvala nenormalnosti kostiju i zuba, koje su se uglavnom sastojale od sklonosti k spontanim prijelomima i odgođene mineralizacije, a koje su bile reverzibilne nakon prekida liječenja.
English: o Uncontrolled hypertension.
Croatian: o Nekontroliranom hipertenzijom.
English: - if you have established ischaemic heart disease, or cerebrovascular disease, e.g. you have been diagnosed with a heart attack, stroke, or transient ischaemic attack (temporary reduction of blood flow to the brain; also known as “mini-stroke”), angina, or blockages of blood vessels to the heart or brain.
Croatian: - ako su Vam dokazali ishemijsku bolest srca ili cerebrovaskularnu bolest, npr. dijagnosticiran Vam je srčani udar, moždani udar ili prolazna ishemijska ataka (privremeno smanjenje dotoka krvi u mozak; također znan i kao mali moždani udar), angina pektoris ili začepljenje krvnih žila srca ili mozga.
English: Therefore, in medical practice, inductively coupled plasma atomic emission spectrometry or atomic absorption spectrometry methods should be used to ensure an accurate assessment of blood and urinary calcium concentrations.
Croatian: Stoga se u kliničkoj praksi valja služiti induktivno spregnutom plazma atomskom emisijskom spektrometrijom ili atomskom apsorpcijskom spektrometrijom, kako bi se osiguralo pouzdano mjerenje koncentracija kalcija u krvi i urinu.
English: The absorption of strontium ranelate is reduced by food, milk and derivative products and therefore, OSSEOR should be administered in-between meals.
Croatian: Apsorpciju stroncijeva ranelata smanjuju hrana, mlijeko i mliječni proizvodi te se stoga OSSEOR mora uzimati između obroka.
English: The anti-fracture studies program of OSSEOR was made up of two placebo-controlled phase III studies: SOTI study and TROPOS study.
Croatian: Program ispitivanja OSSEOR-a u sprječavanju prijeloma sastojao se od dvaju placebom kontroliranih ispitivanja III. faze: ispitivanje SOTI i ispitivanje TROPOS.
English: If you take too many sachets of OSSEOR, tell your doctor or pharmacist.
Croatian: Uzmete li previše vrećica OSSEOR-a, kažite to svome liječniku ili ljekarniku.
English: Non-interventional safety study to evaluate the effectiveness of the applied risk minimisation measures, including a description of the treated patient population in everyday clinical practice, patterns of use and cardiovascular risk.
Croatian: Neintervencijsko ispitivanje sigurnosti primjene s ciljem ispitivanja učinkovitosti primjenjenih mjera minimizacije rizika, uključujući opis liječene populacije u svakodnevnoj kliničkoj praksi,
English: Do not use this medicine after the expiry date which is stated on the box and the sachet after EXP.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji i vrećici iza „Rok valjanosti“.
English: An in vivo clinical interaction study showed that the administration of aluminium and magnesium hydroxides either two hours before or together with strontium ranelate caused a slight decrease in the absorption of strontium ranelate (20-25% AUC decrease), while absorption was almost unaffected when the antacid was given two hours after strontium ranelate.
Croatian: Kliničko istraživanje interakcija in vivo pokazalo je da se primjenom aluminijeva i magnezijeva hidroksida dva sata prije ili istodobno sa stroncijevim ranelatom blago smanjila apsorpcija stroncijeva ranelata (smanjenje AUC za 20-25 %), a da se apsorpcija gotovo uopće nije promijenila kada se antacid davao dva sata nakon stroncijeva ranelata.