FrancophonIA/ELRC3.0 huggingface dataset:
English: Paper/polyethylene/aluminium/polyethylene sachets.
Slovenian: 6.5 Vrsta ovojnine in vsebina Vrečke iz papirja/polietilena/aluminija/polietilena.
English: In this group, over 3 years of treatment, OSSEOR reduced the risk of hip fracture by 36% relative to the placebo group (table 2).
Slovenian: Pri takšnih bolnicah je v 3 letih zdravljenja OSSEOR zmanjšal tveganje za zlome kolka za 36 % v primerjavi s placebom (preglednica 2).
English: In pooled randomised placebo-controlled studies of post-menopausal osteoporotic patients, a significant increase of myocardial infarction has been observed in OSSEOR treated patients as compared to placebo (1.7% versus 1.1 %), with a relative risk of 1.6 (95% CI = [1.07 ; 2.38]).
Slovenian: V združenih randomiziranih, s placebom nadzorovanih študijah so pri bolnicah z osteoporozo po menopavzi opazili značilno povečanje miokardnega infarkta pri bolnicah, ki so se zdravile z zdravilom OSSEOR v primerjavi s placebom (1,7 % v primerjavi z 1,1 %), in relativnim tveganjem 1,6 (95% IZ = [1,07 ; 2,38].
English: Do not use this medicine after the expiry date which is stated on the box and the sachet after EXP.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in vrečki poleg oznake Uporabno do. Datum izteka roka uporabnosti se nanaša na zadnji dan navedenega meseca.
English: As strontium ranelate is not metabolised, no dose adjustment is required in patients with hepatic impairment.
Slovenian: Bolniki z jetrno okvaro Ker se stroncijev ranelat ne presnavlja, bolnikom z jetrno okvaro odmerka ni treba prilagajati.
English: No evidence of clinical interactions or relevant increase of blood strontium levels with medicinal products expected to be commonly prescribed concomitantly with OSSEOR in the target population were found during clinical trials.
Slovenian: V kliničnih študijah ni bilo dokazov za klinična medsebojna delovanja ali pomembno povečanje vrednosti stroncija v krvi ob sočasnem dajanju zdravil, ki jih pogosto z zdravilom OSSEOR jemlje ciljna populacija.
English: Do not take OSSEOR during pregnancy or when you are breastfeeding.
Slovenian: Nosečnost in dojenje Zdravila OSSEOR ne smete jemati med nosečnostjo ali če dojite.
English: However, it is recommended to drink the suspension immediately after preparation (see section 4.2) 6.4 Special precautions for storage
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: o bolnikih s pomembnimi dejavniki tveganja za srčno-žilne dogodke, kot so npr. arterijska hipertenzija, hiperlipidemija, sladkorna bolezen ali kajenje.
English: In Asian countries reported as rare d In pooled placebo-controlled studies of post-menopausal osteoporotic patients, strontium ranelate treated patients (N=3803, 11270 patient years of treatment) compared to placebo (N=3769, 11250 patient years of treatment)
Slovenian: c redkeje poročane v azijskih državah d v združenih s placebom nadzorovanih študijah pri bolnicah z osteoporozo po menopavzi, ki so se zdravile s stroncijevim ranelatom (n = 3.803, 11.270 bolnikov-let zdravljenja) v primerjavi s placebom (n = 3.769, 11.250 bolnikov-let zdravljenja)
English: Non-clinical data revealed no special hazard for humans based on conventional studies of safety pharmacology, genotoxicity and carcinogenic potential.
Slovenian: Predklinični podatki na osnovi običajnih študij farmakološke varnosti, genotoksičnosti in kancerogenega potenciala ne kažejo posebnega tveganja za človeka.
English: - if you have high blood pressure not controlled by treatment.
Slovenian: - če imate neurejen zvišan krvni tlak.
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 antifracture 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),
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).
Slovenian: Pred uvedbo stroncijevega ranelata pri bolnikih s pomembnimi dejavniki tveganja za srčno-žilne dogodke (npr. arterijska hipertenzija, hiperlipidemija, sladkorna bolezen, kajenje) (glejte poglavji 4.3 in 4.8) je potrebno skrbno pretehtati zdravljenje s stroncijevim ranelatom.
English: SOTI involved 1,649 postmenopausal women with established osteoporosis (low lumbar BMD and prevalent vertebral fracture) and a mean age of 70 years.
Slovenian: Študija SOTI je zajela 1649 žensk v obdobju po menopavzi z dokazano osteoporozo (nizko kostno gostoto v ledveni hrbtenici in z obstoječimi zlomi vretenc), s srednjo starostjo 70 let.
English: Therefore, administration of OSSEOR and such products should be separated by at least two hours (see section 5.2).
Slovenian: Zato je priporočljivo, da bolniki jemljejo OSSEOR najmanj dve uri po njihovem zaužitju (glejte poglavje 5.2).
English: Contents of the pack and other information
Slovenian: Shranjevanje zdravila OSSEOR Vsebina pakiranja in dodatne informacije
English: In pooled randomised placebo-controlled studies of post-menopausal osteoporotic patients, a significant increase in myocardial infarction has been observed in OSSEOR treated patients compared to placebo (see section 4.8).
Slovenian: V združenih randomiziranih, s placebom nadzorovanih študijah pri bolnicah z osteoporozo po menopavzi so v primerjavi s placebom opazili pomembno povečanje miokardnega infarkta pri bolnicah, ki so se zdravile z zdravilom OSSEOR (glejte poglavje 4.8).
English: Treatment should be stopped if the patient develops ischaemic heart disease, peripheral arterial disease, cerebrovascular disease or if hypertension is uncontrolled (see section 4.3).
Slovenian: Če se pri bolniku pojavi ishemična bolezen srca, periferna arterijska bolezen, možgansko-žilna bolezen ali nenadzorovana arterijska hipertenzija, je treba zdravljenje prekiniti (glejte poglavje 4.3).
English: Vomiting, abdominal pain, reflux, indigestion, constipation, flatulence, dry mouth, pins and needles, dizziness, vertigo, difficulty in sleeping, inflammation of the liver (hepatitis), oral irritation (such as mouth ulcers and gum inflammation), bone, muscle and/or joint pain, muscle cramps, hair loss, reduction in production of blood cells in the bone marrow, itching, hives, blistering, angioedema
Slovenian: Bruhanje, bolečine v trebuhu, refluks, prebavne težave, zaprtje, vetrovi, suha usta, mravljinčenje in zbadanje, omotica, vrtoglavica, težave s spanjem, vnetje jeter (hepatitis), razdraženje ust (kot so ustne razjede ali vnetje dlesni), bolečine v kosteh, mišicah in/ali sklepih, mišični krči, izpadanje las,
English: Your doctor may advise you to take calcium and vitamin D supplements in addition to OSSEOR.
Slovenian: Zdravnik vam lahko poleg zdravila OSSEOR svetuje pripravke kalcija in vitamina D. Ne jemljite kalcijevih pripravkov pred spanjem hkrati z zdravilom OSSEOR.
English: The best results in managing SJS, TEN or DRESS come from early diagnosis and immediate discontinuation of any suspect drug.
Slovenian: Najboljši izidi zdravljenja Stevens-Johnsonovega sindroma, toksične epidermalne nekrolize ali sindroma DRESS so posledica zgodnje diagnoze in takojšnje prekinitve zdravljenja s katerim koli zdravilom, za katerega obstaja sum.
English: A higher incidence, although still rare, of hypersensitivity reactions including skin rash, SJS or TEN in patients of Asian origin has been reported.
Slovenian: Pri bolnikih azijskega porekla so poročali o večji pojavnosti preobčutljivostnih reakcij, vključno s kožnim izpuščajem, SJS ali TEN, čeprav so bile te še vedno redke.
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.
Slovenian: V primeru bolezni ali stanja, ki privede do nepokretnosti bolnika (glejte poglavje 4.3), je treba zdravljenje z zdravilom OSSEOR nemudoma prekiniti in izvajati ustrezne preventivne ukrepe.
English: OTHER Read the package leaflet before use
Slovenian: DRUGI PODATKI Pred uporabo preberite priloženo navodilo.
English: smoking.
Slovenian: VREČKA
English: In phase III studies, the annual incidence of venous thromboembolism (VTE) observed over 5 years was approximately 0.7%, with a relative risk of 1.4 (95% CI = [1.0 ; 2.0]) in strontium ranelate treated patients as compared to placebo (see section 4.4).
Slovenian: V študijah III. faze je ob stroncijevem ranelatu v primerjavi s placebom letna pojavnost venske trombembolije, zabeležena v petletnem obdobju, znašala približno 0,7 %, z relativnim tveganjem 1,4 (95-% interval zaupanja = [1,0; 2,0]) (glejte poglavje 4.4).
English: Treatment of severe osteoporosis:
Slovenian: Zdravljenje bolnic s pomenopavzno osteoporozo:
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.
Slovenian: - če imate ali ste imeli krvni strdek (npr. v žilah v nogah ali v pljučih); - če ste trajno ali nekaj časa nepokretni, npr. ste vezani na invalidski voziček ali na posteljo, če čakate na operacijo ali po njej okrevate.
English: As a divalent cation, strontium is not metabolised.
Slovenian: Kot dvovalentni kation se stroncij ne presnavlja.
English: Overall incidence rates for adverse reactions with strontium ranelate did not differ from placebo and adverse reactions were usually mild and transient.
Slovenian: Skupne stopnje pojavnosti neželenih učinkov ob stroncijevem ranelatu se niso razlikovale od placeba.
English: No dose adjustment is required in patients with mild-to-moderate renal impairment (30-70 ml/min creatinine clearance) (see section 5.2).
Slovenian: Za bolnike z blago do zmerno ledvično okvaro (očistek kreatinina 30 do 70 ml/min) odmerka ni treba prilagajati (glejte poglavje 5.2).
English: 7 sachets
Slovenian: 7 vrečk
English: OSSEOR 2 g granules for oral suspension Strontium ranelate
Slovenian: OSSEOR 2 g zrnca za peroralno suspenzijo stroncijev ranelat
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION OSSEOR 2 g granules for oral suspension.
Slovenian: IME ZDRAVILA IN POT(I) UPORABE OSSEOR 2 g zrnca za peroralno suspenzijo stroncijev ranelat za peroralno uporabo
English: SOTI
Slovenian: SERIJ
English: In postmenopausal women, strontium ranelate reduces the risk of vertebral and hip fractures (see section
Slovenian: Pri ženskah po menopavzi stroncijev ranelat zmanjša tveganje za zlome vretenc in kolka (glejte poglavje 5.1).
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
English: If the patient has developed SJS, TEN or DRESS with the use of OSSEOR, OSSEOR must not be restarted in this patient at any time.
Slovenian: Če se je zaradi zdravljenja z zdravilom OSSEOR pri bolniku pojavil SJS, TEN ali DRESS, mu zdravljenja z zdravilom OSSEOR nikoli ne smemo ponovno uvesti.
English: Continuation of treatment with OSSEOR in patients developing severe renal impairment should be considered on an individual basis.
Slovenian: Če se razvije huda ledvična okvara, se o nadaljevanju zdravljenja z zdravilom OSSEOR odloča pri vsakem bolniku posebej.
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, diabetes,
Slovenian: - če imate tveganje za bolezen srca, ki vključuje zvišan krvni tlak, zvišan holesterol, sladkorno bolezen in kajenje
English: Good tolerance was shown in a clinical study investigating the repeated administration of 4 g strontium ranelate per day over 25 days in healthy postmenopausal women.
Slovenian: V 25-dnevni študiji so proučevali večkratno jemanje stroncijevega ranelata po 4 g na dan pri zdravih ženskah v obdobju po menopavzi in ugotovili dobro prenašanje.
English: Hip fracture over 3 years
Slovenian: zlomi kolka v 3 letih
English: 38% (17-53), p<0.001
Slovenian: 38 % (17 do 53), P < 0,001
English: Physico-chemical data suggest excretion of Strontium ranelate in human milk OSSEOR should not be used during breast-feeding
Slovenian: Fizikalnokemijski podatki nakazujejo izločanje stroncijevega ranelata v materino mleko.
English: Life-threatening cutaneous reactions (Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN) and drug rash with eosinophilia and systemic symptoms (DRESS)) have been reported with the use of OSSEOR.
Slovenian: Johnsonovem sindromu (SJS), toksični epidermalni nekrolizi (TEN) in z zdravilom povzročenem kožnem izpuščaju z eozinofilijo in sistemskimi simptomi (DRESS - drug rash with eosinophilia and systemic symptoms)).
English: If you have developed Stevens-Johnson syndrome or toxic epidermal necrolysis or DRESS with the use of OSSEOR, you must not be re-started on OSSEOR at any time If you develop a rash or these skin symptoms, 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 opisane simptome, prenehajte z jemanjem zdravila OSSEOR in nemudoma poiščite zdravniško pomoč ter zdravniku povejte, da jemljete to zdravilo.
English: Psychiatric disorders Frequency unknown:a Confusional state Insomnia Nervous system disorders Common: Headache Disturbances in consciousness Memory loss Uncommon: Seizures Frequency unknown:a Paraesthesia Dizziness Vertigo Cardiac disorders Commond: Myocardial infarction Vascular disorders Common: Venous thromboembolism (VTE) Respiratory, thoracic and mediastinal disorders Frequency unknown:a Bronchial hyperreactivity Gastrointestinal disorders Common: Nausea Diarrhoea Loose stools
Slovenian: Pogostid: miokardni infarkt Žilne bolezni Pogosti: venske trombembolije (VTE) Bolezni dihal, prsnega koša in mediastinalnega prostora Neznana pogostnost:a hiperaktivnost bronhijev Bolezni prebavil Pogosti: slabost diareja mehko blato Neznana pogostnost:a bruhanje bolečine v trebuhu razdraženje ustne sluznice (stomatitis in/ali razjede v ustih) gastroezofagealni refluks dispepsija zaprtje flatulenca suha usta
English: No dose adjustment is required in relation to age.
Slovenian: Prilagajanje odmerka pri starejših bolnikih ni potrebno.
English: There is no pharmacokinetic data in patients with severe renal impairment (creatinine clearance below 30 ml/min).
Slovenian: Za bolnike s hudo ledvično okvaro (očistek kreatinina pod 30 ml/min) ni farmakokinetičnih podatkov.
English: Statistically significant increases in femoral neck BMD and total hip BMD (p<0,001) were observed after 12 months.
Slovenian: Po 12 mesecih so opazili statistično značilno povečanje mineralne kostne gostote v vratu stegnenice in celotne mineralne kostne gostote v kolku (p < 0,001).
English: What you need to know before you take osseor Do not take OSSEOR: - if you are allergic to strontium ranelate or any of the other ingredients of OSSEOR (listed in section 6).
Slovenian: - če ste alergični na stroncijev ranelat ali katero koli sestavino tega zdravila (navedeno v poglavju 6);
English: - in adult men, at high risk of fracture, for whom treatment with other medicinal products approved for the treatment of osteoporosis is not possible due to, for example, contraindications or intolerance.
Slovenian: Zdravljenje hude osteoporoze - pri ženskah po menopavzi, - pri odraslih moških, z velikim tveganjem za zlome, pri katerih zdravljenje z drugimi zdravili, ki so odobrena za zdravljenje osteoporoze, zaradi kontraindikacij ali neprenašanja ni mogoče.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/04/287/004 56 sachets
Slovenian: ŠTEVILKA(E) DOVOLJENJA(DOVOLJENJ) ZA PROMET EU/1/04/287/004 56 vrečk
English: It is recommended that you take OSSEOR at bedtime, preferably at least 2 hours after dinner.
Slovenian: Priporočeni odmerek je ena vrečka po 2 g na dan. Priporočljivo je, da OSSEOR jemljete pred spanjem, najbolje vsaj 2 uri po večerji.
English: If you are unsure about this ask your doctor or pharmacist.
Slovenian: Če ste negotovi, se posvetujte s svojim zdravnikom ali farmacevtom.
English: How to store OSSEOR
Slovenian: Shranjevanje zdravila OSSEOR
English: See a doctor straight away if you experience any of these symptoms.
Slovenian: V primeru pojava kateregakoli od opisanih simptomov morate nemudoma obiskati zdravnika.
English: Blood clots.
Slovenian: Krvni strdki.
English: 49% (26-64), p<0.001
Slovenian: 49 % (26 do 64), P < 0,001
English: New vertebral fracture over the 1st year
Slovenian: novi zlomi vretenc v 1 letu
English: Symptoms
Slovenian: Zdravila
English: No dosage adjustment is therefore required in patients with mild-to-moderate renal impairment.
Slovenian: Pri bolnikih z blago do zmerno ledvično okvaro torej odmerka ni potrebno prilagajati.
English: België/Belgique/Belgien S.A. Servier Benelux N.V. Tel: +32 (0)2 529 43 11
Slovenian: België/Belgique/Belgien S.A. Servier Benelux N.V.
English: Uncommon: Seizures.
Slovenian: Občasni: Epileptični napadi.
English: 41% (27-52), p<0.001
Slovenian: 41 % (27 do 52), P < 0,001
English: o Patients at risk of VTE.
Slovenian: o bolnikih s tveganjem za vensko trombembolijo.
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: odmerku po 2 g. Stanje dinamičnega ravnovesja doseže po 2 tednih zdravljenja.
English: What OSSEOR looks like and contents of the pack OSSEOR is available in sachets containing yellow granules for oral suspension.OSSEOR is supplied in boxes of 7, 14, 28, 56, 84 or 100 sachets.
Slovenian: Škatle zdravila OSSEOR vsebujejo 7, 14, 28, 56, 84 ali 100 vrečk.
English: 39% (27-49), p<0.001
Slovenian: 39 % (27 do 49), P < 0,001
English: Puh/Tel: +358 (0)9 279 80 80
Slovenian: Suomi/Finland Servier Finland Oy Puh/Tel: +358 (0)9 279 80 80
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)
English: - if you have severe kidney disease
Slovenian: - če imate tveganje za pojav krvnih strdkov, - če imate hudo bolezen ledvic.
English: When a VTE occurs, OSSEOR should be stopped.
Slovenian: Če se pojavi venska trombembolija, moramo zdravljenje z zdravilom OSSEOR ukiniti.
English: Potentially life-threatening skin rashes (Stevens-Johnson syndrome, toxic epidermal necrolysis and severe hypersensitivity reactions (DRESS)) have been reported with the use of OSSEOR.
Slovenian: Pri zdravljenju z zdravilom OSSEOR so poročali o morebitno življenje ogrožajočih kožnih izpuščajih (Stevens-Johnsonovem sindromu, toksični epidermalni nekrolizi in hudih preobčutljivostnih reakcijah
English: In patients over 80 years of age at inclusion, a pooled analysis of SOTI and TROPOS studies showed that OSSEOR reduced the relative risk of experiencing new vertebral fractures by 32% over 3 years (incidence of 19.1% with strontium ranelate vs. 26.5% with placebo).
Slovenian: pokazala, da je OSSEOR v 3-letnem zdravljenju zmanjšal relativno tveganje za pojav novih zlomov vretenc za 32 % (ob stroncijevem ranelatu je bila pojavnost 19,1 % v primerjavi s 26,5 % ob placebu).
English: OSSEOR is a non-hormonal medicine used to treat severe osteoporosis: - in postmenopausal women, - in men, at high risk of fracture, for whom other alternative treatments are not possible.
Slovenian: Kaj je zdravilo OSSEOR in za kaj ga uporabljamo OSSEOR je nehormonsko zdravilo za zdravljenje hude osteoporoze: - pri ženskah po menopavzi, - pri moških,
English: Hepatic impairment
Slovenian: Srčni ishemični dogodki
English: NAME OF THE MEDICINAL PRODUCT OSSEOR 2 g granules for oral suspension Strontium ranelate
Slovenian: IME ZDRAVILA OSSEOR 2 g zrnca za peroralno suspenzijo
English: In an a-posteriori analysis of patients from the pooled SOTI and TROPOS studies with baseline lumbar spine and / or femoral neck BMD in the osteopenic range and without prevalent fracture but with at least one additional risk factor for fracture (N=176), OSSEOR reduced the risk of a first vertebral fracture by 72% over 3 years (incidence of vertebral fracture 3.6% with strontium ranelate vs. 12.0% with placebo).
Slovenian: toda z vsaj enim dodatnim dejavnikom tveganja zanje (n = 176), je skupna analiza a posteriori pokazala, da je OSSEOR zmanjšal tveganje prvega zloma vretenc za 72 % v 3 letih (pojavnost zlomov vretenc 3,6 % ob stroncijevem ranelatu v primerjavi z 12,0 % ob placebu).
English: Tabulated list of adverse reactions
Slovenian: limfadenopatija (v povezavi s preobčutljivostnimi kožnimi reakcijami) Preiskave
English: Maltodextrin
Slovenian: dermatitis ekcem
English: Strontium ranelate is not recommended for patients with severe renal impairment (creatinine clearance below 30 ml/min) (see sections 4.4 and 5.2).
Slovenian: zdravilo OSSEOR ni priporočeno pri bolnikih z očistkom kreatinina pod 30 ml/min (glejte poglavje
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. V 3-letnem zdravljenju v študiji SOTI je OSSEOR zmanjšal relativno tveganje novih zlomov vretenc za 41 % (preglednica 1).
English: Method of administration
Slovenian: študija TROPOS
English: MARKETING AUTHORISATION NUMBER(S) EU/1/04/287/002
Slovenian: ŠTEVILKA(E) DOVOLJENJA(DOVOLJENJ) ZA PROMET EU/1/04/287/002
English: New vertebral fracture over 3 years
Slovenian: novi zlomi vretenc v 3 letih
English: MARKETING AUTHORISATION NUMBER(S) EU/1/04/287/001
Slovenian: ŠTEVILKA(E) DOVOLJENJA(DOVOLJENJ) ZA PROMET EU/1/04/287/001
English: Servier Laboratories c/o Icepharma hf Sími: +354 540 8000
Slovenian: Servier Laboratories c/o Icepharma hf
English: Potentially life-threatening skin rashes (Stevens-Johnson syndrome, toxic epidermal necrolysis) have been reported (see section 2).
Slovenian: Poročali so o morebitno življenje ogrožajočih kožnih izpuščajih (Stevens-Johnsonovem sindromu,
English: MARKETING AUTHORISATION NUMBER(S) EU/1/04/287/003
Slovenian: ŠTEVILKA(E) DOVOLJENJA(DOVOLJENJ) ZA PROMET EU/1/04/287/003
English: TROPOS
Slovenian: Način uporabe
English: • The treatment should be either discontinued or stopped in the following situations: o If the patient develops ischaemic heart disease, peripheral arterial disease, cerebrovascular disease or if hypertension is uncontrolled, the treatment should be stopped.
Slovenian: o če se pri bolniku pojavi ishemična bolezen srca, periferna arterijska bolezen, možgansko žilna bolezen ali nenadzorovana arterijska hipertenzija, je potrebno z zdravljenjem prenehati, o v primeru bolezni ali stanja, ki privede do nepokretnosti bolnika, je potrebno zdravljenje z zdravilom OSSEOR prekiniti,
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Outer carton
Slovenian: PODATKI NA ZUNANJI OVOJNINI ŠKATLA
English: Strontium ranelate.
Slovenian: - Zdravilna učinkovina je stroncijev ranelat.
English: Treatment of postmenopausal osteoporosis:
Slovenian: Mehanizem delovanja In vitro stroncijev ranelat:
English: This should be taken into account when interpreting BMD changes during treatment with OSSEOR.
Slovenian: Med razlaganjem sprememb mineralne kostne gostote ob zdravilu
English: Strontium excretion occurs via the kidneys and the gastrointestinal tract.
Slovenian: Izločanje stroncija poteka skozi ledvice in prebavila.
English: PHARMACEUTICAL FORM AND CONTENTS
Slovenian: Izgled zdravila OSSEOR in vsebina pakiranja
English: Absorption
Slovenian: Plodnost