FrancophonIA/ELRC3.0 huggingface dataset:
English: The treatment should only be started by a doctor with experience in treating osteoporosis.
Slovenian: Zdravljenje lahko uvede le zdravnik, ki ima izkušnje z zdravljenjem osteoporoze.
English: If you forget to take OSSEOR:
Slovenian: Če ste pozabili vzeti zdravilo OSSEOR:
English: Frequency in Clinical Trials was similar in the drug and placebo group.
Slovenian: Pogostnost v kliničnih preskušanjih je bila podobna v skupini, ki je prejemala zdravilo in skupini, ki je prejemala s placebo.
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: Zdravilo OSSEOR lahko medsebojno deluje z mlekom in mlečnimi izdelki, zato je za pravilno delovanje pomembno, da zdravilo OSSEOR mešate le z vodo.
English: If you stop taking OSSEOR:
Slovenian: Če prenehate jemati zdravilo OSSEOR:
English: Therefore, in view of available data regarding the PASS final study report, the PRAC considered that changes to the conditions of the marketing authorization were warranted.
Slovenian: Odbor PRAC zato ob upoštevanju razpoložljivih podatkov iz končnega poročila študije PASS smatra, da so spremembe pogojev dovoljenja za promet z zdravilom upravičene.
English: ElderlyPopulation 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: Additional signs may include ulcers in the mouth, throat, nose, genitals and conjunctivitis (red and swollen eyes).
Slovenian: Dodatni znaki lahko vključujejo razjede v ustih, v grlu, nosu in na genitalijah ter vnetje očesne veznice (rdeče in otekle oči).
English: Servier Pharma d.o.o.
Slovenian: Slovenija Servier Pharma d.o.o.
English: − Heart attack: sudden crushing pains in your chest which may reach your left arm, jaw, stomach, back and/or shoulders.
Slovenian: − Srčni infarkt: nenadna ostra bolečina v prsih, ki lahko seva v levo ramo, čeljust, želodec, hrbet in/ali rame.
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:
Slovenian: Po predhodnem pogovoru in privolitvi pristojnega nacionalnega organa v posamezni državi članici, kjer se zdravilo OSSEOR trži, bo imetnik dovoljenja za promet z zdravilom zagotovil, da bodo vsi zdravniki, za katere se predvideva, da bodo predpisovali zdravilo OSSEOR, dobili naslednji izobraževalni paket:
English: OSSEOR is a medicine used to treat severe osteoporosis: - in postmenopausal women, - in adult men, at high risk of fracture, for whom other alternative treatments are not possible.
Slovenian: OSSEOR je zdravilo za zdravljenje hude osteoporoze: - pri ženskah po menopavzi, - pri odraslih moških, z visokim tveganjem za zlome, pri katerih druga alternativna zdravljenja niso mogoča.
English: Patients who have the HLA-A*33:03 and/or the HLA-B*58:01 genes are more likely to develop a serious skin reaction than those who do not have the genes.
Slovenian: Pri bolnikih, ki imajo gen HLA-A*33:03 in/ali HLA-B*58:01, je večja verjetnost, da se pojavi resna kožna reakcija, kot pri tistih, ki teh genov nimajo.
English: However, it is recommended to drink the suspension immediately after preparation (see section 4.2)
Slovenian: Vseeno je suspenzijo priporočljivo popiti takoj po pripravi (glejte poglavje 4.2).
English: • OSSEOR should only be used with caution in: o Patients with significant risk factors for cardiovascular events such as hypertension, hyperlipidaemia, diabetes mellitus or smoking.
Slovenian: • Zdravilo OSSEOR je potrebno uporabljati previdno pri: o bolnikih s pomembnimi dejavniki tveganja za srčno-žilne dogodke, kot so npr. arterijska hipertenzija, hiperlipidemija, sladkorna bolezen ali kajenje.
English: The absolute bioavailability of strontium is about 25% (range 19-27%) after an oral dose of 2 g strontium ranelate.
Slovenian: Absolutna biološka uporabnost stroncija je približno 25 % (razpon 19 do 27 %) po peroralnem odmerku 2 g stroncijevega ranelata.
English: In most cases, these values spontaneously reverted to normal without change in treatment.
Slovenian: V večini so se vrednosti spontano normalizirale kljub nadaljevanju zdravljenja.
English: If OSSEOR is used inadvertently during pregnancy, treatment must be stopped.
Slovenian: Če bolnica nehote jemlje zdravilo OSSEOR med nosečnostjo, mora jemanje prekiniti.
English: Other symptoms may be nausea/vomiting, sweating, shortness of breath, palpitations, (extreme) tiredness and/or dizziness.
Slovenian: Ostali simptomi so lahko slabost/bruhanje, znojenje, kratka sapa, palpitacije, (izjemna) utrujenost in/ali omotica.
English: OSSEOR also decreased the number of patients with a body height loss of at least 1 cm as compared to placebo.
Slovenian: Zdravilo OSSEOR je v primerjavi s placebom zmanjšal tudi število bolnic z izgubo telesne višine za najmanj 1 cm.
English: What OSSEOR is and what it is used for What you need to know before you take OSSEOR How to take OSSEOR
Slovenian: Kaj je zdravilo OSSEOR in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo OSSEOR Kako jemati zdravilo OSSEOR Možni neželeni učinki
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: V študijah III. faze je ob vključitvi 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: 84 sachets
Slovenian: 84 vrečk
English: You should stop taking OSSEOR if you have to take oral tetracyclines such as doxycycline or quinolones such as ciprofloxacin (two types of antibiotics).
Slovenian: Prenehajte jemati zdravilo OSSEOR, če se zdravite s peroralnimi tetraciklini kot je npr. doksiciklin ali kinoloni kot je npr. ciprofloksacin (dve vrsti antibiotikov).
English: The outcome of DRESS is favorable in most cases upon discontinuation of OSSEOR and after initiation of corticosteroid therapy when necessary.
Slovenian: V večini primerov je izid sindroma DRESS ugoden po prekinitvi jemanja zdravila OSSEOR in uvedbi zdravljenja s kortikosteroidi, če je le-to potrebno.
English: 100 sachets
Slovenian: 100 vrečk
English: Do not take OSSEOR during pregnancy or when you are breastfeeding.
Slovenian: Zdravila OSSEOR ne smete jemati med nosečnostjo ali če dojite.
English: See instructions below.
Slovenian: (Glejte spodnja navodila).
English: Date of latest renewal: 22/05/2014
Slovenian: Datum prve odobritve: 21/09/2004 Datum zadnjega podaljšanja: 22/05/2014
English: In phase III studies, which demonstrated the anti-fracture efficacy of OSSEOR treatment, measured mean BMD increased from baseline with OSSEOR by approximately 4% per year at the lumbar spine and 2% per year at the femoral neck, reaching 13% to 15% and 5% to 6% respectively after 3 years, depending on the study.
Slovenian: V študijah III. faze, ki so dokazovale učinkovitost zdravila OSSEOR pri preprečevanju zlomov, se je izmerjena srednja mineralna kostna gostota ob zdravilu OSSEOR povečevala od izhodišča za približno 4 % na leto v ledveni hrbtenici in 2 % na leto v vratu stegnenice, vrednosti pa so dosegle 13 do 15 % oziroma 5 do 6 % po 3 letih, odvisno od študije.
English: * In Asian countries reported as rare # For adverse reaction not observed in clinical trials, the upper limit of the 95% confidence interval is not higher than 3/X with X representing the total sample size summed up across all relevant clinical trials and studies.
Slovenian: # Za neželene učinke, ki jih niso opažali v kliničnih preskušanjih, zgornja meja 95% interval zaupanja ne presega 3/X, pri čemer X predstavlja skupno velikost vzorca, povzetega iz vseh pomembnih kliničnih preskušanj in študij.
English: As divalent cations can form complexes with oral tetracycline (e.g. doxycycline) and quinolone antibiotics (e.g. ciprofloxacin) at the gastro-intestinal 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 (npr. doksiciklinom) in kinolonskimi antibiotiki (npr. ciprofloksacinom) v prebavilih in tako zmanjšujejo njihovo absorpcijo, sočasno jemanje stroncijevega ranelata s tovrstnimi zdravili ni priporočeno.
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.
Slovenian: Poleg zdravljenja s stroncijevim ranelatom po 2 g na dan ali placebom so bolnice ves čas obeh študij jemale prilagojene pripravke kalcija in vitamina D.
English: Each sachet also contains 20 mg of aspartame (E951).
Slovenian: Ena vrečka vsebuje tudi 20 mg aspartama (E951).
English: - Current or previous venous thromboembolic events (VTE), including deep vein thrombosis and pulmonary embolism.
Slovenian: - Prisotna ali predhodna venska trombembolija (VTE - venous thromboembolic events), vključno z globoko vensko trombozo in pljučno embolijo.
English: Κύπρος C.A.
Slovenian: C.A.
English: Maximum plasma concentrations are reached 3-5 hours after a single dose of 2 g. Steady state is reached after 2 weeks of treatment.
Slovenian: Največjo koncentracijo v plazmi doseže 3 do 5 ur po enkratnem odmerku po 2 g. Stanje dinamičnega ravnovesja doseže po 2 tednih zdravljenja.
English: Reduction in production of blood cells in the bone marrow.
Slovenian: Redki: Zmanjšana tvorba krvnih celic v kostnem mozgu.
English: OSSEOR works by reducing bone breakdown and stimulating rebuilding of bone and therefore reduces the risk of fracture.
Slovenian: Zdravilo OSSEOR deluje tako, da zmanjšuje razgradnjo kosti in spodbuja njeno gradnjo, s čimer zmanjšuje tveganje za zlome.
English: Take the granules contained in the sachets as a suspension in a glass containing a minimum of 30 ml (approximately one third of a standard glass) of water.
Slovenian: Zrnca iz vrečk zaužijte kot suspenzijo v kozarcu vode, ki vsebuje najmanj 30 ml (približno tretjino običajnega kozarca) vode.
English: The granules in the sachets must be taken as a suspension in a glass containing a minimum of 30 ml (approximately one third of a standard glass) of water.
Slovenian: Zrnca iz vrečke moramo popiti v obliki suspenzije v kozarcu vode, ki vsebuje najmanj 30 ml (približno eno tretjino standardnega kozarca) vode.
English: If you take more sachets of OSSEOR than recommended by your doctor, tell your doctor or pharmacist.
Slovenian: Če ste vzeli večji odmerek zdravila OSSEOR, kot bi smeli Če ste vzeli več vrečk zdravila OSSEOR, kot vam jih je priporočil vaš zdravnik, obvestite svojega zdravnika ali farmacevta.
English: Over 12 months, a statistically significant increase in mean lumbar spine BMD, main efficacy criteria (E (SE) = 5.32% (0.75); 95%CI = [3.86 ; 6.79]; p<0,001), similar to that observed in the pivotal anti-fracture phase III studies carried-out in postmenopausal women, was observed.
Slovenian: Po 12 mesecih so opažali statistično značilna povečanja srednje mineralne kostne gostote v ledveni hrbtenici, glavni kriterij učinkovitosti (E (SE) = 5,32 % (0,75); 95 % IZ = [3.86; 6.79); p < 0,001), podobno kot v temeljnih študijah III. faze, ki so dokazovale učinkovitost preprečevanja zlomov pri ženskah po menopavzi.
English: The pharmacokinetics of strontium and ranelic acid have been assessed in healthy young men and healthy postmenopausal women, as well as during longterm 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: In a pooled analysis of randomised placebo-controlled studies in post-menopausal osteoporotic patients, 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: V združeni analizi randomiziranih, s placebom nadzorovanih raziskav pri bolnicah z osteoporozo po menopavzi, sta bila najpogostejša neželena učinka slabost in diareja, ki so ju večinoma opažali na začetku zdravljenja, kasneje pa ni bilo opaznih razlik med skupinama.
English: How OSSEOR works
Slovenian: Kako zdravilo OSSEOR deluje
English: The highest risk for occurrence of SJS or TEN is within the first weeks of treatment and usually around 3-6 weeks for DRESS
Slovenian: Največje tveganje za pojav SJS ali TEN je v prvih tednih zdravljenja, za pojav sindroma DRESS pa običajno okoli 3 do 6 tednov od uvedbe zdravljenja.
English: Pregnancy and breast-feeding:
Slovenian: Nosečnost in dojenje:
English: Its plasma clearance is about 12 ml/min (CV 22%) and its renal clearance about 7 ml/min (CV 28%).
Slovenian: Očistek v plazmi znaša približno 12 ml/min (koeficient variacije 22 %), v ledvicah pa okoli 7 ml/min (koeficient variacije 28 %).
English: OSSEOR, which contains the substance strontium ranelate, belongs to a group of medicines used to treat bone diseases.
Slovenian: Zdravilo OSSEOR, ki vsebuje učinkovino stroncijev ranelat, spada v skupino zdravil za zdravljenje bolnikov z boleznimi kosti.
English: Table 2: Incidence of patients with hip fracture and relative risk reduction in patients with BMD ≤ -2.4 SD (NHANES III) and age ≥ 74 years
Slovenian: Preglednica 2: Pojavnost zlomov kolka in zmanjšanje relativnega tveganja pri bolnicah z mineralno kostno gostoto ≤ - 2,4 SD (NHANES III) in starostjo ≥ 74 let
English: Table 1: Incidence of patients with vertebral fracture and relative risk reduction Study
Slovenian: Preglednica 1: Pojavnost zlomov vretenc pri bolnicah in zmanjšanje relativnega tveganja
English: If not used immediately after reconstitution, the preparation should be consumed within 24 hours.
Slovenian: Če suspenzije ne uporabite takoj po rekonstituciji, jo je potrebno popiti v roku 24 ur.
English: − Blood clots in veins: pain, redness, swelling in your leg, sudden chest pain or difficulty breathing.
Slovenian: − Krvni strdki v venah: bolečina, rdečina, otekanje noge, nenadna bolečina v prsih ali težko dihanje.
English: During treatment, if you experience an allergic reaction (such as swelling of the face, tongue or throat, difficulty in breathing or swallowing, skin rash), you must immediately stop taking OSSEOR and seek medical advice (see section 4).
Slovenian: Če med zdravljenjem doživite hude alergijske reakcije (kot so zatekanje obraza, jezika ali grla, težave pri dihanju ali požiranju, kožni izpuščaj), morate nemudoma prenehati z jemanjem zdravila OSSEOR in poiskati zdravniško pomoč (glejte poglavje 4).
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 zdravilo OSSEOR jemljemo pred spanjem, najbolje najmanj dve uri po obroku (glejte poglavji 4.5 in 5.2).
English: OSSEOR contains aspartame, a source of phenylalanine, which may be harmful for people with phenylketonuria.
Slovenian: Pomožna snov Zdravilo OSSEOR vsebuje aspartam, vir fenilalanina, ki je lahko škodljiv za bolnike s fenilketonurijo.
English: In phase III placebo-controlled studies, strontium ranelate treatment was associated with an increase in the annual incidence of venous thromboembolism (VTE), including pulmonary embolism (see section 4.8).
Slovenian: V študijah III. faze, nadzorovanih s placebom, je bilo zdravljenje s stroncijevim ranelatom povezano s povečanjem letne pojavnosti venske trombembolije, vključno s pljučno embolijo (glejte poglavje 4.8).
English: If you develop a rash or serious skin symptoms (see section 4), stop taking OSSEOR, seek urgent advice from a doctor and tell him that you are taking this medicine.
Slovenian: Če na koži opazite izpuščaj ali hude kožne reakcije (glejte poglavje 4), prenehajte z jemanjem zdravila OSSEOR in nemudoma poiščite zdravniško pomoč ter zdravniku povejte, da jemljete to zdravilo.
English: A. MANUFACTURER(S)RESPONSIBLE FOR BATCH RELEASE
Slovenian: A. IZDELOVALEC (IZDELOVALCI), ODGOVOREN (ODGOVORNI) ZA SPROŠČANJE SERIJ
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 zdravilo OSSEOR.
English: HLA-A*33:03 and HLA-B*58:01 alleles have been identified as potential genetic risk factors for strontium ranelate-associated SJS/TEN in Han Chinese patients from a retrospective, case-control, pharmacogenetic study.
Slovenian: Alela HLA-A*33:03 in HLA-B*58:01 sta bila v retrospektivni farmakogenetski študiji primerov in kontrol opredeljena kot možna genetska dejavnika tveganja za pojav SJS/TEN, povezanih z jemanjem stroncijevega ranelata, pri bolnikih kitajske etnične skupine Han.
English: How to take OSSEOR
Slovenian: Kako jemati zdravilo OSSEOR
English: OSSEOR contains aspartame (E951):
Slovenian: Zdravilo OSSEOR vsebuje aspartam (E951):
English: If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Slovenian: Če imate kakršnakoli dodatna vprašanja o uporabi tega zdravila, se posvetujte z zdravnikom ali farmacevtom.
English: In postmenopausal women, strontium ranelate reduces the risk of vertebral and hip fractures (see section 5.1).
Slovenian: Pri ženskah po menopavzi stroncijev ranelat zmanjša tveganje za zlome vretenc in kolka (glejte poglavje 5.1).
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 zdravilo OSSEOR jemati v času med dvema obrokoma.
English: Scientific conclusions and grounds for the variation to the terms of the marketing authorisation
Slovenian: Priloga IV Znanstveni zaključki in podlaga za spremembo pogojev dovoljenj za promet z zdravilom
English: The efficacy and safety of strontium ranelate have been established in a broad age range (up to 100 years at inclusion) of adult men and postmenopausal women with osteoporosis.
Slovenian: Učinkovitost in varnost stroncijevega ranelata so dokazali pri odraslih moških in pri ženskah z osteoporozo v obdobju po menopavzi, v širokem razponu starosti (do 100 let ob vključitvi).
English: Taking into account the PRAC Assessment Report for the non-interventional imposed PASS final study report for the medicinal product mentioned above, the scientific conclusions of CHMP are as follows:
Slovenian: Upoštevajoč poročilo Odbora za oceno tveganja na področju farmakovigilance (PRAC) o končnem poročilu študije o varnosti zgoraj navedenega zdravila po pridobitvi dovoljenja za promet (PASS) je Odbor za zdravila za uporabo v humani medicini (CHMP) sprejel naslednje znanstvene zaključke:
English: Driving and using machines: Osseor is unlikely to affect your ability to drive or use machines.
Slovenian: Vpliv na sposobnost upravljanja vozil in strojev Ni verjetno, da bi zdravilo OSSEOR vplivalo na vašo sposobnost upravljanja vozil in strojev.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each sachet contains 2 g of strontium ranelate.
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA Ena vrečka vsebuje 2 g stroncijevega ranelata.
English: EU/1/04/287/005 84 sachets (3 packs of 28) EU/1/04/287/006 100 sachets
Slovenian: EU/1/04/287/005 84 vrečk (3 pakiranja po 28 vrečk) EU/1/04/287/006 100 vrečk
English: Fertility No effects were observed on males and females fertility in animal studies.
Slovenian: Plodnost V študijah na živalih niso opazili učinkov na plodnost moških in žensk.
English: Talk to your doctor or pharmacist before taking OSSEOR: - if you are at risk of heart disease, this includes high blood pressure, high cholesterol,
Slovenian: Pred začetkom jemanja zdravila OSSEOR se posvetujte s svojim zdravnikom ali farmacevtom: - če imate tveganje za bolezen srca, ki vključuje zvišan krvni tlak, zvišan holesterol, sladkorno bolezen in kajenje - če imate tveganje za pojav krvnih strdkov, - če imate hudo bolezen ledvic.
English: No dose adjustment is required in patients with hepatic impairment(see section 5.2).
Slovenian: Jetrna okvara Bolnikom z jetrno okvaro odmerka ni treba prilagajati (glejte poglavje 5.2).
English: − Signs of severe hypersensitivity reactions (DRESS): initially as flu-like symptoms and a rash on the face then an extended rash with a high temperature (uncommon), increased levels of liver enzymes seen in blood tests (uncommon) an increase in a type of white blood cell (eosinophilia) (rare) and enlarged lymph nodes (uncommon).
Slovenian: − Znaki hudih preobčutljivostnih reakcij (DRESS): v začetku se pojavijo gripi podobni simptomi in izpuščaji na obrazu, nato razširjen izpuščaj z visoko telesno temperaturo (občasni), zvišane vrednosti jetrnih encimov, opažene v preiskavah krvi (občasni), povečano število določenega tipa belih krvnih celic (eozinofilija) (redki) ter povečane bezgavke (občasni).
English: In the absence of bone safety data in patients with severe renal impairment treated with strontium ranelate, OSSEOR is not recommended in patients with a creatinine clearance below 30 ml/min (see section 5.2).
Slovenian: Ker ni podatkov o varnosti za kost pri bolnikih s hudo ledvično okvaro, ki bi jemali stroncijev ranelat, zdravilo OSSEOR ni priporočeno pri bolnikih z očistkom kreatinina pod 30 ml/min (glejte poglavje 5.2).
English: The recommended dose is one 2g sachet a day.
Slovenian: Priporočeni odmerek je ena vrečka po 2 g na dan.
English: It is recommended that you take OSSEOR at bedtime, preferably at least 2 hours after dinner.
Slovenian: Priporočljivo je, da zdravilo OSSEOR jemljete pred spanjem, najbolje vsaj 2 uri po večerji.
English: Discontinuation of therapy was mainly due to nausea.
Slovenian: Poglavitni vzrok za prekinitev zdravljenja je bila slabost.
English: If the following happens to you, stop using OSSEOR and talk to your doctor immediately:
Slovenian: Če se pri vas pojavi katerikoli od spodaj navedenih neželenih učinkov, takoj prenehajte z jemanjem zdravila OSSEOR in se takoj posvetujte s svojim zdravnikom:
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.
Slovenian: Tveganje za nastanek hudih kožnih reakcij je za Stevens-Johnsonov sindrom in toksično epidermalno nekrolizo največje v prvih tednih zdravljenja, za sindrom DRESS pa običajno okoli 3 do 6 tednov od uvedbe zdravljenja.
English: Measurement of strontium concentration in iliac crest bone biopsies from patients treated for up to 60 months with strontium ranelate 2 g/day indicate that bone strontium concentrations may reach a plateau after about 3 years
Slovenian: Meritve koncentracije stroncija v biopsijah črevničnega grebena, odvzetih pri bolnikih, ki so jemali stroncijev ranelat po 2 g na dan do 60 mesecev, kažejo, da koncentracija stroncija v kosti najverjetneje doseže plato po približno 3 letih zdravljenja.
English: OSSEOR is for oral use.
Slovenian: Zdravilo OSSEOR je namenjeno za peroralno uporabo.
English: Rare:
Slovenian: Pogosti:
English: Vomiting, abdominal pain, reflux, indigestion, constipation, flatulence, difficulty in sleeping, inflammation of the liver (hepatitis), swelling in limbs, bronchial hyperreactivity (symptoms include wheezing and shortness of breath and cough), increased level of a muscle enzyme (Creatine phosphokinase), increased levels of cholesterol.
Slovenian: Bruhanje, bolečine v trebuhu, refluks, prebavne težave, zaprtje, vetrovi, težave s spanjem, vnetje jeter (hepatitis), otekanje okončin, hiperaktivnost bronhijev (simptomi vključujejo sopenje, kratko sapo in kašelj), zvišana vrednost mišičnega encima (keratin fosfokinaze), zvišane vrednosti holesterola.