FrancophonIA/ELRC3.0 huggingface dataset:
English: Signs of a blood clot include painful swelling in your leg, sudden chest pain or difficulty breathing.
Slovenian: Znaki krvnega strdka vključujejo boleče otekanje noge, nenadno bolečino v prsih ali težko dihanje.
English: • The initiation of treatment with OSSEOR should be based on an assessment of the individual patient's overall risk.
Slovenian: • Odločitev o uvedbi zdravljenja z zdravilom OSSEOR mora temeljiti na podlagi ocene skupnega tveganja za posameznega bolnika.
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.
Slovenian: Če imate osteoporozo, telo razgradi več kosti, kot je tvori, tako da počasi nastaja izguba kostne mase, kosti pa postanejo tanjše in krhkejše.
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.
Slovenian: Čeprav so študije o uporabi zdravila pokazale, da je stroncijev ranelat v suspenziji stabilen še 24 ur po pripravi, moramo suspenzijo popiti takoj po pripravi.
English: • Within the prescriber guide there will be a check-list to remind prescribers of the contraindications, warnings and precautions prior to prescribing and to support the regular monitoring of cardiovascular risk.
Slovenian: • Navodila za zdravnika vsebujejo tudi seznam za preverjanje, ki bo zdravnika spomnil na kontraindikacije, opozorila in previdnostne ukrepe preden bo predpisal zdravilo, in zagotovil redno spremljanje tveganja za srčno-žilne dogodke.
English: You may lie down immediately after taking OSSEOR if you wish.
Slovenian: Če želite, se lahko uležete takoj po jemanju zdravila OSSEOR.
English: The data on skeletal strontium ranelate accumulation in longer term exposure is limited.
Slovenian: Podatki o kopičenju stroncijevega ranelata v skeletu pri dolgotrajni izpostavljenosti so omejeni.
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.
Slovenian: - če imate ali ste imeli težave s krvnim pretokom (periferna arterijska bolezen), ali če ste imeli operacijo arterij na nogah;
English: Single administration of doses up to 11 g in healthy young male volunteers did not cause any particular symptoms.
Slovenian: Jemanje enkratnih odmerkov do 11 g ni povzročilo posebnih simptomov niti pri zdravih mladih moških prostovoljcih.
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.
Slovenian: Priporočljivo je, da OSSEOR jemljete v času med dvema obrokoma, najbolje pred spanjem, najmanj dve uri po zaužitju hrane, mleka ali mlečnih izdelkov in dodatkov kalcija.
English: Pharmacokinetics in special clinical situations
Slovenian: Farmakokinetika pri posebnih kliničnih skupinah Starejši
English: Italia I.F.B.
Slovenian: I.F.B.
English: OSSEOR is for oral use.
Slovenian: OSSEOR je namenjen za peroralno uporabo.
English: If you have stopped treatment due to hypersensitivity reactions, do not take OSSEOR again
Slovenian: Če ste prenehali z zdravljenjem zaradi preobčutljivostnih reakcij, zdravila OSSEOR ne jemljite več.
English: Percentage of Patients Experiencing the adverse reaction Treatment Strontium ranelate (n=3352)
Slovenian: Odstotek bolnic, ki so doživele neželene učinke Zdravljenje stroncijev ranelat (n=3352)
English: Therapy should not be restarted until the initiating condition has resolved and the patient is fully mobile.
Slovenian: Zdravljenja ne smemo ponovno uvesti, dokler bolezen ali stanje ne izzveni in je bolnik popolnoma pokreten.
English: Talk to your doctor if any effects become troublesome or persist.
Slovenian: Obvestite svojega zdravnika, če opazite, da katerikoli učinek postane neprijeten ali traja dlje časa.
English: In most cases, these values spontaneously reverted to normal without change in treatment.
Slovenian: V večini primerov so se vrednosti spontano normalizirale kljub nadaljevanju zdravljenja.
English: The treatment should only be started by a doctor with experience of treating osteoporosis.
Slovenian: Zdravljenje lahko uvede le zdravnik, ki ima izkušnje z zdravljenjem osteoporoze.
English: Population pharmacokinetic data showed no relationship between age and apparent clearance of strontium in the target population.
Slovenian: Populacijski farmakokinetični podatki kažejo, da ni povezave med starostjo in navideznim očistkom stroncija pri ciljnem prebivalstvu.
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.
Slovenian: Stroncijev ranelat sestavljata 2 atoma stabilnega stroncija in 1 molekula ranelske kisline, organskega dela, ki omogoča najboljši kompromis glede na molekulsko maso, farmakokinetiko in prenašanje zdravila.
English: Empty the granules from the sachet into a glass;
Slovenian: Zrnca stresite iz vrečke v kozarec.
English: When treating patients over 80 years at risk of VTE, the need for continued treatment with OSSEOR should be re-evaluated.
Slovenian: Pri zdravljenju bolnikov, starejših od 80 let s tveganjem za vensko trombembolijo, moramo potrebo po nadaljnjem zdravljenju z zdravilom OSSEOR ponovno ovrednotiti.
English: Your doctor will evaluate the conditions of your heart and blood vessels regularly, generally every 6 to 12 months for as long you are taking OSSEOR.
Slovenian: Vaš zdravnik bo redno, vsakih 6 do 12 mesecev, ocenil stanje vašega srca in krvnih žil, vse dokler boste jemali zdravilo OSSEOR.
English: Following episodes of overdoses during clinical trials (up to 4 g/day for a maximal duration of 147 days), no clinically relevant events were observed.
Slovenian: Zdravljenje Po obdobjih prevelikega odmerjanja v kliničnih študijah (do 4 g na dan največ 147 dni) niso opazili klinično pomembnih dogodkov.
English: Patients treated with strontium ranelate should receive vitamin D and calcium supplements if dietary intake is inadequate.
Slovenian: Bolniki, ki jih zdravimo s stroncijevim ranelatom, morajo jemati pripravke vitamina D in kalcija, če je vnos s prehrano nezadosten.
English: -You should stop taking OSSEOR if you have to take oral tetracyclines or quinolones (two types of antibiotics).
Slovenian: - Prenehajte jemati OSSEOR, če se zdravite s peroralnimi tetraciklini ali kinoloni (dve vrsti antibiotikov).
English: Excipient with known effect: Each sachet also contains 20 mg of aspartame (E951).
Slovenian: Pomožne snovi z znanim učinkom: Ena vrečka vsebuje tudi 20 mg aspartama (E951).
English: Treatment of Osteoporosis in men:
Slovenian: Zdravljenje osteoporoze pri moških:
English: OSSEOR also decreased the number of patients with a body height loss of at least 1 cm as compared to placebo.
Slovenian: OSSEOR je v primerjavi s placebom zmanjšal tudi število bolnic z izgubo telesne višine za najmanj 1 cm.
English: The risk of vein thrombosis (blood clots in the leg or lungs) may be increased in the event of lengthy immobilisation.
Slovenian: Tveganje venske tromboze (krvni strdki v nogah ali v pljučih) se lahko poveča, če ste dlje časa nepokretni
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.
Slovenian: Dostopni podatki kažejo, da ta dejavnika povzročata približno 50 % izmerjene spremembe mineralne kostne gostote v 3 letih zdravljenja z zdravilom OSSEOR po 2 g na dan.
English: 92284 Suresnes cedex France
Slovenian: 92284 Suresnes cedex Francija
English: The clinical consequence of osteoporosis is fractures.
Slovenian: Klinična posledica osteoporoze so zlomi.
English: Food, milk and milk products reduce the absorption of strontium ranelate.
Slovenian: Hrana, mleko in mlečni izdelki zmanjšujejo absorpcijo stroncijevega ranelata.
English: The safety and efficacy of OSSEOR in children aged below 18 years have not been established.
Slovenian: Pediatrična populacija Varnost in učinkovitost zdravila OSSEOR pri otrocih, mlajših od 18 let, nista bili dokazani.
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.
Slovenian: Najpogostejši sta bili slabost in diareja, ki so ju večinoma opažali na začetku zdravljenja, kasneje pa ni bilo opaznih razlik med skupinama.
English: In the event of substantial overdose, vomiting may be considered to remove unabsorbed active substance.
Slovenian: V primeru izrazitega prevelikega odmerjanja lahko izzovemo bruhanje za odstranjevanje neabsorbirane učinkovine.
English: Together, SOTI and TROPOS enrolled 1,556 patients over 80 years at inclusion (23.1% of the study population).
Slovenian: Skupaj sta študiji SOTI in TROPOS zajeli 1556 bolnic, ki so bile ob vključitvi starejše od 80 let (23,1 % proučevane populacije).
English: Strontium ranelate does not inhibit cytochrome P450 enzymes.
Slovenian: Stroncijev ranelat ne zavira encimov citokroma P450.
English: Oral supplementation with vitamin D has no effect on strontium exposure.
Slovenian: Peroralno dodajanje vitamina D ne vpliva na izpostavljenost stronciju.
English: Absorbed ranelic acid is rapidly eliminated unchanged via the kidneys.
Slovenian: Absorbirana ranelska kislina se iz telesa hitro izloča nespremenjena skozi ledvice.
English: If you suffer from phenylketonuria (a rare, hereditary disorder of the metabolism) talk to your doctor before you start to take this medicine.
Slovenian: Če imate fenilketonurijo (redka dedna motnja presnove), se posvetujte s svojim zdravnikom, preden boste začeli jemati to zdravilo.
English: Additional signs to look for include ulcers in the mouth, throat, nose, genitals and conjunctivitis (red and swollen eyes).
Slovenian: Dodatni znaki, na katere morate biti pozorni, vključujejo razjede v ustih, grlu, nosu in na genitalijah ter vnetje očesne veznice (rdeče in otekle oči).
English: They may advise you to drink milk or take antacids to reduce the absorption of the active ingredient.
Slovenian: Lahko vam bosta svetovala pitje mleka ali jemanje antacidov za zmanjševanje absorpcije zdravila.
English: The prescriber guide and checklist shall contain the following key messages:
Slovenian: Navodilo za zdravnika in seznam za preverjanje mora vsebovati naslednje pomembne informacije:
English: A number of risk factors are associated with postmenopausal osteoporosis including low bone mass, low bone mineral density, early menopause, a history of smoking and a family history of osteoporosis.
Slovenian: S pomenopavzno osteoporozo so povezani številni dejavniki tveganja, vključno z nizko kostno maso, nizko mineralno kostno gostoto, zgodnjo menopavzo, kajenjem v anamnezi in osteoporozo v družini.
English: Temporary or permanent immobilisation due to e.g. post-surgical recovery or prolonged bed rest.
Slovenian: Začasna ali stalna nepokretnost zaradi npr. pooperativnega okrevanja ali podaljšanega mirovanja v postelji.
English: Osteoporosis-therapy is usually required for a long period.
Slovenian: Zdravljenje osteoporoze je običajno dolgotrajno.
English: Before starting treatment, patients should be evaluated with respect to cardiovascular risk.
Slovenian: Pred uvedbo zdravljenja je treba zato oceniti bolnikovo srčno-žilno tveganje.
English: • Prescriber guide and checklist
Slovenian: • Navodila za zdravnika in seznam za preverjanje
English: The binding of strontium to human plasma proteins is low (25%) and strontium has a high affinity for bone tissue.
Slovenian: Njegova vezava na beljakovine v plazmi pri ljudeh je majhna (25 %) in ima veliko afiniteto za kostno tkivo.
English: If you forget to take OSSEOR:
Slovenian: Če ste pozabili vzeti zdravilo OSSEOR
English: Food, milk and derivative products, and medicinal products containing calcium may reduce the bioavailability of strontium ranelate by approximately 60-70%.
Slovenian: Hrana, mleko in mlečni izdelki ter zdravila, ki vsebujejo kalcij, lahko zmanjšajo biološko uporabnost stroncijevega ranelata za približno 60 do 70 %.
English: Rare: Severe hypersensitivity reactions (DRESS: see section 2)
Slovenian: Hude preobčutljivostne reakcije (sindrom DRESS: glejte poglavje 2).
English: Due to the pharmacokinetic properties of strontium, no effect is expected.
Slovenian: Glede na farmakokinetične lastnosti stroncija ne pričakujemo nobenega učinka.
English: The absolute bioavailability of strontium is about 25% (range 19-27%) after an oral dose of 2 g strontium ranelate.
Slovenian: Absorpcija Absolutna biološka uporabnost stroncija je približno 25 % (razpon 19 do 27 %) po peroralnem odmerku 2 g stroncijevega ranelata.
English: LIST OF EXCIPIENTS Also contains aspartame (E 951).
Slovenian: SEZNAM POMOŽNIH SNOVI Vsebuje tudi aspartam (E 951).
English: In phase III studies, as compared to placebo, biochemical markers of bone formation (bone-specific alkaline phosphatase and C-terminal propeptide of type I procollagen) increased and those of bone resorption (serum C-telopeptide and urinary N-telopeptide cross links) decreased from the third month of treatment up to 3 years.
Slovenian: V študijah III. faze so se v primerjavi s placebom biokemični kazalci tvorjenja kosti (kostno specifična alkalna fosfataza in C-terminalni propeptid prokolagena tipa I) povečali, kazalci resorpcije kosti (C-telopeptidi v serumu in premreženi N-telopeptidi v urinu) pa zmanjšali od tretjega meseca zdravljenja do treh let.
English: Excipient OSSEOR contains a source of phenylalanine, which may be harmful for people with phenylketonuria.
Slovenian: OSSEOR vsebuje vir fenilalanina, ki je lahko škodljiv za bolnike s fenilketonurijo.
English: Other medicines and OSSEOR:
Slovenian: Druga zdravila in zdravilo OSSEOR
English: OSSEOR works by reducing bone breakdown and stimulating rebuilding of bone and therefore reduces the risk of fracture.
Slovenian: OSSEOR deluje tako, da zmanjšuje razgradnjo kosti in spodbuja njeno gradnjo, s čimer zmanjšuje tveganje za zlome.
English: In accordance with good medical practice, periodic assessment of renal function is recommended in patients with chronic renal impairment.
Slovenian: V skladu z dobro zdravniško prakso je pri bolnikih s kronično ledvično okvaro priporočljivo redno ocenjevati delovanje ledvic.
English: The elimination of strontium is time and dose independent.
Slovenian: Izločanje stroncija iz telesa je neodvisno od časa in odmerka.
English: In bone tissue of treated animals and humans, strontium is mainly adsorbed onto the crystal surface and only slightly substitutes for calcium in the apatite crystal of newly formed bone.
Slovenian: V kostnem tkivu zdravljenih živali in ljudi se stroncij predvsem adsorbira na kristalno površino in le v majhni meri zamenjuje kalcij v apatitnih kristalih novonastale kosti.
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.
Slovenian: Zato je treba pri meritvah v zdravstveni praksi uporabljati metodo atomske emisijske spektrometrije z induktivno spojeno plazmo ali atomske absorpcijske spektrometrije, da bi zagotovili natančno določanje koncentracije kalcija v krvi in urinu.
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.
Slovenian: Ker dvovalentni kationi lahko tvorijo kompleks s peroralnimi tetraciklini in kinolonskimi antibiotiki v prebavilih in tako zmanjšujejo njihovo absorpcijo, sočasno jemanje stroncijevega ranelata s tovrstnimi zdravili ni priporočeno.
English: Table 1: Incidence of patients with vertebral fracture and relative risk reduction Placebo
Slovenian: Preglednica 1: Pojavnost zlomov vretenc pri bolnicah in zmanjšanje relativnega tveganja Placebo
English: There are no data from the use of strontium ranelate in pregnant women.
Slovenian: Podatki o uporabi stroncijevega ranelata pri nosečnicah niso na voljo.
English: The combined effects of strontium distribution in bone (see section 5.2) and increased X-ray absorption of strontium as compared to calcium, leads to an amplification of bone mineral density (BMD) measurement by dual-photon X-ray absorptiometry (DXA).
Slovenian: Skupni učinek porazdelitve stroncija v kosti (glejte poglavje 5.2) in povečane rentgenske absorpcije stroncija v primerjavi s kalcijem privede do povečanja mineralne kostne gostote (BMD), izmerjene z dvofotonsko rentgensko absorpciometrijo (DXA).
English: Intake of strontium ranelate with calcium or food reduces the bioavailability of strontium by approximately 60-70%, compared with administration 3 hours after a meal.
Slovenian: Vnos stroncijevega ranelata s kalcijem ali hrano zmanjšuje biološko uporabnost stroncija za približno 60 do 70 % v primerjavi z jemanjem 3 ure po obroku.
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.
Slovenian: Farmakokinetiko stroncija in ranelske kisline so proučevali pri zdravih mladih moških in zdravih ženskah v obdobju po menopavzi ter dolgoročno pri moških z osteoporozo ter ženskah z osteoporozo v obdobju po menopavzi, vključno pri starejših ženskah.
English: However, when this dosing regimen is impractical due to the recommended administration of OSSEOR at bedtime, concomitant intake remains acceptable.
Slovenian: Kadar pa tovrsten režim odmerjanja ni praktičen zaradi priporočenega jemanja zdravila OSSEOR pred spanjem, sočasno jemanje ostaja sprejemljivo.
English: OSSEOR, which contains the substance strontium ranelate, belongs to a group of medicines used to treat bone diseases.
Slovenian: OSSEOR, ki vsebuje učinkovino stroncijev ranelat, spada v skupino zdravil za zdravljenje bolnikov z boleznimi kosti.
English: Long-term safety has been evaluated in postmenopausal women with osteoporosis treated for up to 60 months with strontium ranelate 2 g/day (n=3,352) or placebo (n=3,317) in phase III studies.
Slovenian: Dolgoročno varnost so ovrednotili pri ženskah z osteoporozo v obdobju po menopavzi, ki so jih do 60 mesecev zdravili s stroncijevim ranelatom po 2 g na dan (n = 3352) ali placebom (n = 3317) v študijah III. faze.
English: If you take too many sachets of OSSEOR, tell your doctor or pharmacist.
Slovenian: Če ste vzeli preveč vrečk zdravila OSSEOR, obvestite svojega zdravnika ali farmacevta.
English: OSSEOR can interact with milk and milk products, so it is important that you mix OSSEOR only with water to be sure it works properly.
Slovenian: OSSEOR lahko medsebojno deluje z mlekom in mlečnimi izdelki, zato je za pravilno delovanje pomembno, da
English: In phase III studies, 85% of the patients had a creatinine clearance between 30 and 70 ml/min and 6% below 30 ml/min at inclusion, and the mean creatinine clearance was about 50 ml/min.
Slovenian: 85 % bolnikov imelo očistek kreatinina med 30 in 70 ml/min in 6 % pod 30 ml/min, srednja vrednost pa je bila okoli 50 ml/min.
English: In particular, in intact rats, strontium ranelate increases trabecular bone mass, trabeculae number and thickness; this results in an improvement of bone strength.
Slovenian: Zlasti pri intaktnih podganah stroncijev ranelat povečuje trabekularno kostno maso, število in debelino trabekul, kar izboljša trdnost kosti.
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).
Slovenian: Zaradi počasne absorpcije OSSEOR jemljemo pred spanjem, najbolje najmanj dve uri po obroku (glejte poglavji 4.5 in 5.2).
English: No interaction was observed with oral supplementation of vitamin D.
Slovenian: Medsebojnega delovanja s peroralnimi dodatki vitamina D niso opazili.
English: • SmPC
Slovenian: • SPC
English: If OSSEOR is used inadvertently during pregnancy, treatment must be stopped.
Slovenian: Če bolnica nehote jemlje OSSEOR med nosečnostjo, mora jemanje prekiniti.
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.
Slovenian: Osteoporozo opredeljujemo kot mineralno kostno gostoto v hrbtenici ali kolku 2,5 SD ali več pod srednjo vrednostjo pri zdravih mladih odraslih.
English: These effects were reported at bone strontium levels 2-3 times higher than bone strontium levels in humans up to 3 years of treatment.
Slovenian: O tovrstnih učinkih so poročali pri vrednostih stroncija v kosteh, ki so bile 2- do 3-krat večje kot vrednosti stroncija pri ljudeh, ki so bili zdravljeni do 3 leta..
English: At high doses, animal studies have shown reversible bone effects in the offspring of rats and rabbits treated during pregnancy (see section 5.3).
Slovenian: Študije na živalih so ob velikih odmerkih pokazale reverzibilne učinke na kosti pri potomstvu podgan in zajcev, zdravljenih med brejostjo (glejte poglavje 5.3).
English: - Once reconstituted in water, the suspension is stable for 24 hours.
Slovenian: - Po rekonstituciji z vodo je suspenzija stabilna 24 ur.
English: - If you are taking medicines containing calcium, you should leave at least 2 hours before you take OSSEOR.
Slovenian: - Če jemljete zdravila, ki vsebujejo kalcij, je priporočljivo počakati najmanj 2 uri, preden boste vzeli OSSEOR.
English: Strontium interferes with colorimetric methods for the determination of blood and urinary calcium concentrations.
Slovenian: Stroncij moti kolorimetrične metode za določanje koncentracije kalcija v krvi in urinu.
English: - The other ingredients are aspartame (E 951), maltodextrin, mannitol (E 421).
Slovenian: - Pomožne snovi so aspartam (E951), maltodekstrin, manitol (E421).
English: As a precautionary measure, OSSEOR treatment should be suspended during treatment with oral tetracycline or quinolone antibiotics.
Slovenian: Kot previdnostni ukrep je treba med zdravljenjem s peroralnimi tetraciklini ali kinolonskimi antibiotiki jemanje zdravila OSSEOR prekiniti.
English: If you take it by accident during pregnancy or breastfeeding, stop taking it straight away and talk to your doctor.
Slovenian: Če ga med nosečnostjo ali dojenjem nehote zaužijete, takoj prenehajte z jemanjem in se posvetujte z zdravnikom.
English: There are no data in patients to demonstrate elimination kinetics of strontium from bone off-therapy.
Slovenian: Ni podatkov pri bolnikih, ki bi prikazovali kinetiko odstranjevanja stroncija iz kosti po koncu zdravljenja.
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.
Slovenian: In vivo študija o kliničnih medsebojnih delovanjih je pokazala, da jemanje aluminijevega in magnezijevega hidroksida dve uri pred stroncijevim ranelatom ali skupaj z njim blago zmanjšuje njegovo absorpcijo (zmanjšanje površine pod krivuljo za 20 do 25 %), medtem ko se absorpcija skorajda ni spreminjala, če so bolniki antacide jemali dve uri po stroncijevem ranelatu.
English: The absorption of strontium ranelate is reduced by food, milk and derivative products and therefore, OSSEOR should be administered in-between meals.
Slovenian: Absorpcija stroncijevega ranelata se zmanjša ob hrani ter mleku in mlečnih izdelkih, zato je treba OSSEOR jemati v času med dvema obrokoma.