natgillin/translations-raw huggingface dataset:
At high doses, animal studies have shown reversible bone effects in the offspring of rats and rabbits treated during pregnancy (see section 5.3). 
Študije na živalih so ob velikih odmerkih pokazale reverzibilne učinke na kosti pri potomstvu podgan in zajcev, zdravljenih med brejostjo (glejte poglavje 5.3).
- Once reconstituted in water, the suspension is stable for 24 hours. 
- Po rekonstituciji z vodo je suspenzija stabilna 24 ur.
- If you are taking medicines containing calcium, you should leave at least 2 hours before you take OSSEOR. 
- Če jemljete zdravila, ki vsebujejo kalcij, je priporočljivo počakati najmanj 2 uri, preden boste vzeli OSSEOR.
Strontium interferes with colorimetric methods for the determination of blood and urinary calcium concentrations. 
Stroncij moti kolorimetrične metode za določanje koncentracije kalcija v krvi in urinu.
- The other ingredients are aspartame (E 951), maltodextrin, mannitol (E 421). 
- Pomožne snovi so aspartam (E951), maltodekstrin, manitol (E421).
As a precautionary measure, OSSEOR treatment should be suspended during treatment with oral tetracycline or quinolone antibiotics. 
Kot previdnostni ukrep je treba med zdravljenjem s peroralnimi tetraciklini ali kinolonskimi antibiotiki jemanje zdravila OSSEOR prekiniti.
If you take it by accident during pregnancy or breastfeeding, stop taking it straight away and talk to your doctor. 
Če ga med nosečnostjo ali dojenjem nehote zaužijete, takoj prenehajte z jemanjem in se posvetujte z zdravnikom.
There are no data in patients to demonstrate elimination kinetics of strontium from bone off-therapy. 
Ni podatkov pri bolnikih, ki bi prikazovali kinetiko odstranjevanja stroncija iz kosti po koncu zdravljenja.
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. 
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.
The absorption of strontium ranelate is reduced by food, milk and derivative products and therefore, OSSEOR should be administered in-between meals. 
Absorpcija stroncijevega ranelata se zmanjša ob hrani ter mleku in mlečnih izdelkih, zato je treba OSSEOR jemati v času med dvema obrokoma.
In patients with mild-to-moderate renal impairment (30-70 ml/min creatinine clearance), strontium clearance decreases as creatinine clearance decreases (approximately 30% decrease over the creatinine clearance range 30 to 70 ml/min) and thereby induces an increase in strontium plasma levels. 
Pri bolnikih z blago do zmerno ledvično okvaro (očistek kreatinina 30 do 70 ml/min), se očistek stroncija zmanjšuje z očistkom kreatinina (zmanjšanje za približno 30 % v razponu očistka kreatinina 30 do 70 ml/min), zato se poveča vrednost stroncija v plazmi.
• Key signs and symptoms of myocardial infarction, VTE and serious skin reactions. 
• glavne znake in simptome miokardnega infarkta, venske trombembolije in hudih kožnih reakcij,
Developmental toxicity studies in rats and rabbits resulted in bone and tooth abnormalities (e.g. bent long bones and wavy ribs) in the offspring. 
Študije razvojne toksičnosti pri podganah in zajcih so pokazale nepravilnosti v kosteh in zobeh (na primer ukrivljene dolge kosti in valovita rebra) pri potomstvu.
Due to its high polarity, the absorption, distribution and binding to plasma proteins of ranelic acid are low. 
Zaradi velike polarnosti ima ranelska kislina majhno absorpcijo, porazdelitev in vezavo na beljakovine v plazmi.
Driving and using machines: Osseor is unlikely to affect your ability to drive or use machines. 
Vpliv na sposobnost upravljanja vozil in strojev Ni verjetno, da bi OSSEOR vplival na vašo sposobnost upravljanja vozil in strojev.
Efficacy of OSSEOR to reduce the risk of new vertebral fracture was confirmed in the TROPOS study, including for osteoporotic patients without fragility fracture at baseline. 
Učinkovitost zdravila OSSEOR pri zmanjševanju tveganja novih zlomov vretenc so potrdili v študiji TROPOS, vključno z bolnicami, ki na izhodišču niso imele fragilnostnih zlomov.
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. 
Kronično peroralno dajanje stroncijevega ranelata v velikih odmerkih je pri glodalcih povzročilo nepravilnosti v kosteh in zobeh, predvsem spontane zlome in zapoznelo mineralizacijo, ki so po prekinitvi zdravljenja izginili.
With respect to clinical vertebral fractures (defined as fractures associated with back pain and/or a body height loss of at least 1 cm), the relative risk was reduced by 38%. 
Relativno tveganje kliničnih zlomov vretenc (opredeljenih kot zlomov, povezanih z bolečino v hrbtu, zmanjšanjem telesne višine za najmanj 1 cm ali obojim) se je zmanjšalo za 38 %.
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. 
Ocena kakovosti življenja po specifični lestvici QUALIOST (Quality of Life Questionnaire in Osteoporosis) in seštevku za skupno dojemanje zdravja po splošni lestvici SF-36 (Short Form 36) je pokazala koristne učinke zdravila OSSEOR v primerjavi s placebom.
Due to the relatively slow absorption of strontium, food and calcium intake should be avoided both before and after administration of OSSEOR. 
Zaradi sorazmerno počasne absorpcije stroncija se moramo izogibati uživanju hrane in kalcija tako pred jemanjem zdravila OSSEOR kot med njim.
If you take more OSSEOR than you should: 
Če ste vzeli večji odmerek zdravila OSSEOR, kot bi smeli
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. 
Zrnca iz vrečke moramo popiti v obliki suspenzije v kozarcu vode, ki vsebuje najmanj 30 ml
Each sachet contains 2 g of strontium ranelate. 
Ena vrečka vsebuje 2 g stroncijevega ranelata.
Nausea, diarrhoea, headache, skin irritation, memory troubles, fainting fit. 
Slabost, diareja, glavobol, vzdražena koža, težave s spominom, omedlevica.
There is no accumulation of ranelic acid and no evidence of metabolism in animals and humans. 
Ranelska kislina se ne kopiči in ni dokazov, da bi se presnavljala pri živalih ali ljudeh.
A. MANUFACTURER(S)RESPONSIBLE FOR BATCH RELEASE 
A. IZDELOVALEC (IZDELOVALCI), ODGOVOREN (ODGOVORNI) ZA SPROŠČANJE
The efficacy and safety of strontium ranelate have been established in a broad age range (up to 100 years at inclusion) of postmenopausal women with osteoporosis. 
Učinkovitost in varnost stroncijevega ranelata so dokazali pri ženskah z osteoporozo v obdobju po menopavzi, v širokem razponu starosti (do 100 let ob vključitvi).
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. 
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
• OSSEOR is only indicated for use in patients with severe osteoporosis 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. 
• Zdravilo OSSEOR je indicirano samo za zdravljenje bolnikov s hudo osteoporozo z velikim tveganjem za zlome, pri katerih zdravljenje z drugimi zdravili, ki so odobrena za zdravljenje osteoporoze, zaradi kontraindikacij ali neprenašanja ni mogoče.
Statistically significant increases in BMD were observed as early as 6 months following initiation of OSSEOR treatment versus placebo. 
Statistično značilno povečanje mineralne kostne gostote v primerjavi s placebom je bilo opaženo že v 6 mesecih po začetku zdravljenja z zdravilom OSSEOR.
During OSSEOR treatment, these cardiovascular risks should be monitored on a regular basis generally every 6 to 12 months. 
Med zdravljenjem z zdravilom OSSEOR je potrebno spremljati tveganje za srčno-žilne dogodke v rednih časovnih presledkih, vsakih 6 do 12 mesecev.
Current or previous venous thromboembolic events (VTE), including deep vein thrombosis and pulmonary embolism. 
Prisotna ali predhodna venska trombembolija (VTE - venous thromboembolic events), vključno z globoko vensko trombozo in pljučno embolijo.
Established, current or past history of ischaemic heart disease, peripheral arterial disease and/or cerebrovascular disease. 
Dokazana trenutna ali pretekla anamneza ishemične bolezni srca, periferne arterijske bolezni in/ali možgansko-žilne bolezni.
• The patient alert card should be given to every patient. 
• Zdravnik mora vsakemu bolniku izročiti kartico z opozorili za bolnika.
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 
zelo pogosti: pojavijo se lahko pri več kot 1 od 10 bolnikov pogosti: pojavijo se lahko pri največ 1 od 10 bolnikov občasni: pojavijo se lahko pri največ 1 od 100 bolnikov redki: pojavijo se lahko pri največ 1 od 1.000 bolnikov zelo redki: pojavijo se lahko pri največ 1 od 10.000 bolnikov neznana pogostnost: pogostnosti iz razpoložljivih podatkov ni mogoče oceniti
Administration of milk or antacids may be helpful to reduce the absorption of the active substance. 
Zaužitje mleka ali antacidov lahko pripomore k zmanjševanju absorpcije učinkovine.
PHARMACEUTICAL FORM Granules for oral suspension Yellow granules 
FARMACEVTSKA OBLIKA zrnca za peroralno suspenzijo rumena zrnca
(such as swollen face, tongue or throat, difficulty in breathing or swallowing), swelling in limbs, feeling unwell, feeling confused, bronchial hyperreactivity (symptoms include wheezing,shortness of breath and cough). 
(kot so zatekel obraz, jezik ali grlo, težave pri dihanju ali požiranju), otekanje okončin, slabo počutje, občutek zmedenosti, hiperaktivnost bronhijev (simptomi vključujejo težko dihanje, kratko sapo in kašelj).
The following adverse reactions have been reported during clinical studies and/or post marketing use with Strontium ranelate.Adverse reactions, defined as adverse events considered at least possibly attributable to strontium ranelate treatment in phase III studies are listed below using the following convention (frequencies versus placebo): very common (>1/10); common (>1/100, <1/10); uncommon (>1/1,000, <1/100); rare (>1/10,000, <1/1,000); very rare (<1/10,000) ; not known (cannot be estimated from the available data). 
Neželeni učinki, opredeljeni kot neželeni učinki, ki jih je vsaj mogoče pripisati zdravljenju s stroncijevim ranelatom v študijah III. faze, so našteti po naslednjem pravilu (pogostnost v primerjavi s placebom): zelo pogosti (> 1/10), pogosti (> 1/100, < 1/10), občasni (> 1/1.000, < 1/100), redki (> 1/10.000, < 1/1.000), zelo redki (< 1/10.000); neznana pogostnost (ni mogoče oceniti iz razpoložljivih podatkov).
In vitro, strontium ranelate: - increases bone formation in bone tissue culture as well as osteoblast precursor replication and collagen synthesis in bone cell culture; - reduces bone resorption by decreasing osteoclast differentiation and resorbing activity. 
- povečuje tvorjenje kosti v kulturah kostnega tkiva in replikacijo prekurzorjev osteoblastov ter sintezo kolagena v kulturah kostnih celic; - zmanjšuje resorpcijo kosti z zmanjševanjem diferenciacije osteoklastov in resorpcijske dejavnosti.
Similar benefits were demonstrated in women with multiple fractures at baseline. 
Podoben koristni učinek so opazili pri ženskah, ki so na izhodišču že imele več zlomov.
Secondary to the pharmacological effects of strontium ranelate, slight decreases in calcium and parathyroid hormone (PTH) serum concentrations, increases in blood phosphorus concentrations and in total alkaline phosphatase activity were observed, with no observed clinical consequences. 
Sekundarno po farmakoloških učinkih stroncijevega ranelata so poročali o blagem zmanjšanju koncentracije kalcija in paratiroidnega hormona v serumu ter povečanju fosforja v krvi in dejavnosti celotne alkalne fosfataze, brez opaženih kliničnih posledic.
This results in a rebalance of bone turnover in favour of bone formation. 
Na ta način se premena kosti ponovno uravnovesi v korist njihovega tvorjenja.
Once reconstituted in water, the suspension is stable for 24 hours. 
Po pripravi zrnc z vodo je suspenzija stabilna 24 ur.
- 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. 
- če imate potrjeno ishemično bolezen srca, ali možgansko-žilno bolezen, npr. ugotovili so vam srčno kap, možgansko kap ali prehodni ishemični napad (začasno zmanjšanje dotoka krvi v možgane; znan tudi kot ‘'mini možganska kap''), angino pektoris ali zamašitev krvnih žil, ki vodijo v srce ali možgane;
Posology The recommended dose is one 2 g sachet once daily by oral administration. 
Priporočeni odmerek je ena vrečka po 2 g enkrat na dan peroralno.
The highest risk for occurrence of SJS or TEN is within the first weeks of treatment and usually around 36 weeks for DRESS 
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.
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). 
Venska trombembolija 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).
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 of treatment. 
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.
The anti-fracture studies program of OSSEOR was made up of two placebo-controlled phase III studies: SOTI study and TROPOS study. 
Program študij z zdravilom OSSEOR za preprečevanje zlomov sta sestavljali dve s placebom nadzorovani študiji III. faze: SOTI (Spinal Osteoporosis Therapeutic Intervention) in TROPOS (Treatment of Peripheral Osteoporosis).
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. 
Tveganje za nastanek hudih kožnih reakcij je za Stevens-Johnonov sindrom in toksično epidermalno nekrolizo največje v prvih tednih zdravljenja, za sindrom DRESS pa običajno okoli 3 do 6 tednov od uvedbe zdravljenja.
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: 
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:
Fertility No effects were observed on males and females fertility in animal studies. 
V študijah na živalih niso opazili učinkov na plodnost moških in žensk.
Discontinuation of therapy was mainly due to nausea (1.3% and 2.2% in the placebo and strontium ranelate groups respectively). 
Poglavitni vzrok za prekinitev zdravljenja je bila slabost (1,3 % ob placebu oziroma 2,2 % ob stroncijevem ranelatu).
Strontium ranelate does not modify the bone crystal characteristics. 
Stroncijev ranelat ne vpliva na lastnosti kostnih kristalov.
OSSEOR is contra-indicated in patients with a past history of venous thromboembolic events (see section 4.3) and should be used with caution in patients at risk of VTE. 
Zdravilo OSSEOR je kontraindicirano pri bolnikih z vensko trombembolijo v anamnezi (glejte poglavje 4.3), pri bolnikih s tveganjem za vensko trombembolijo pa ga moramo uporabljati previdno.
These included: nonsteroidal anti-inflammatory agents (including acetylsalicylic acid), anilides (such as paracetamol), H2 blockers and proton pump inhibitors, diuretics, digoxin and cardiac glycosides, organic nitrates and other vasodilators for cardiac diseases, calcium channel blockers, beta blockers, ACE inhibitors, angiotensin II antagonists, selective beta-2 adrenoceptor agonists, oral anticoagulants, platelet aggregation inhibitors, statins, fibrates and benzodiazepine derivatives. 
Tovrstna zdravila so: nesteroidna protivnetna zdravila (vključno z acetilsalicilno kislino), anilidi (na primer paracetamol), antagonisti histaminskih receptorjev H2 in zaviralci protonske črpalke, diuretiki, digoksin in srčni glikozidi, organski nitrati in drugi vazodilatatorji za bolnike z boleznimi srca, zaviralci kalcijevih kanalčkov, blokatorji beta receptorjev, zaviralci angiotenzinske konvertaze, antagonisti angiotenzina II, selektivni agonisti adrenergičnih receptorjev β2, peroralni antikoagulanti, zaviralci agregacije trombocitov, statini, fibrati ter derivati benzodiazepina.
You should not leave it more than 24 hours before you drink it. 
Že pripravljeno zdravilo pred pitjem ne sme stati več kot 24 ur.
Stevens-Johnson syndrome and toxic epidermal necrolysis appear initially as reddish target-like spots or circular patches often with central blisters on the trunk. 
Stevens-Johnsonov sindrom in toksična epidermalna nekroliza se sprva pojavita v obliki rdečkastih, tarči podobnih pik ali krožnih lis na trupu, v sredini katerih so pogosto mehurji.
In iliac crest bone biopsies obtained after up to 60 months of treatment with strontium ranelate 2 g/day in phase III trials, no deleterious effects on bone quality or mineralisation were observed. 
V biopsijah črevničnega grebena, ki so jih pridobili po največ 60 mesecih zdravljenja s stroncijevim ranelatom po 2 g na dan v študijah III. faze, niso opazili škodljivih učinkov na kakovost ali mineralizacijo kosti.
It is therefore preferable to take antacids at least two hours after OSSEOR. 
Zato je antacide priporočljivo jemati najmanj dve uri po zdravilu OSSEOR.
Relative Risk Reduction vs. placebo (95%CI), p value 
Zmanjšanje relativnega tveganja v primerjavi s placebom (95-% interval zaupanja), vrednost P
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. 
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.
OSSEOR contains aspartame: 
Zdravilo OSSEOR vsebuje aspartam.
The efficacy of OSSEOR was demonstrated in men with osteoporosis in a 2-year, double-blind, placebo-controlled study with a main analysis after one year in 243 patients (Intention to treat population, 161 patients received strontium ranelate) at high risk of fracture (mean age 72,7 years; mean lumbar BMD T-score value of -2.6; 28% of prevalent vertebral fracture). 
Učinkovitost zdravila OSSEOR je bila pri moških z osteoporozo dokazana v dvojno slepi, s placebom nadzorovani študiji, ki je trajala 2 leti, z glavno analizo po enem letu pri 243 bolnikov (ITTpopulacija bolnikov, ki so jih nameravali zdraviti, 161 bolnikov je prejemalo stroncijev ranelat) s povečanim tveganjem za zlome (srednja starost 72,7 let; vrednost T srednje mineralne kostne gostote v ledveni hrbtenici -2,6; obstoječi zlomi vretenc pri 28 %).
Recovery could be slow and recurrences of the syndrome have been reported in some cases after discontinuation of corticosteroid therapy. 
v nekaterih primerih pa so poročali tudi o ponovnem pojavu sindroma po prekinitvi zdravljenja s kortikosteroidi.
28 sachets 
28 vrečk
Its plasma clearance is about 12 ml/min (CV 22%) and its renal clearance about 7 ml/min (CV 28%). 
12 ml/min (koeficient variacije 22 %), v ledvicah pa okoli 7 ml/min (koeficient variacije 28 %).
However, osteoporosis makes you more likely to have fractures (break bones), especially in your spine, hips and wrists. 
Vendar se zaradi osteoporoze poveča tveganje, da boste doživeli zlom kosti, zlasti v hrbtenici, kolku in zapestju.
How to take osseor 
Kako jemati zdravilo OSSEOR
There is no pharmacokinetic data in patients with hepatic impairment. 
Za bolnike z jetrno okvaro ni farmakokinetičnih podatkov.
MARKETING AUTHORISATION HOLDER LES LABORATOIRES SERVIER 50, rue Carnot 
Imetnik dovoljenja za promet z zdravilom Les Laboratoires Servier 50, rue Carnot
New clinical vertebral fracture over 3 years 
novi klinični zlomi vretenc v 3 letih
If symptoms or signs of SJS or TEN (e.g. progressive skin rash often with blisters or mucosal lesions) or DRESS (e.g. rash, fever, eosinophilia and systemic involvement (e.g. adenopathy, hepatitis, interstitial nephropathy, interstitial lung disease) are present, OSSEOR treatment should be discontinued immediately. 
Če se pojavijo simptomi ali znaki SJS ali TEN (npr. napredujoč kožni izpuščaj, pogosto z mehurji ali poškodbami sluznice) ali sindroma DRESS (npr. izpuščaj, zvišana telesna temperatura, eozinofilija in sistemski zapleti (npr. adenopatija, hepatitis, intersticijska nefropatija, intersticijska pljučna bolezen)) je treba zdravljenje z zdravilom OSSEOR nemudoma prekiniti.
PHARMACEUTICAL FORM AND CONTENTS Granules for oral suspension. 
FARMACEVTSKA OBLIKA IN VSEBINA zrnca za peroralno suspenzijo
- If you take antacids (medicines to relieve heartburn) you should take them at least 2 hours after OSSEOR. 
- Če jemljete antacide (zdravila proti zgagi), jih vzemite najmanj 2 uri po jemanju zdravila OSSEOR.
METHOD AND ROUTE(S) OF ADMINISTRATION For oral use 
POSTOPEK IN POT(I) UPORABE ZDRAVILA za peroralno uporabo
36% (0-59), p=0.046 
36 % (0 do 59), P = 0,046
In postmenopausal women, strontium ranelate reduces the risk of fracture at the spine and at the hip. 
Pri ženskah po menopavzi stroncijev ranelat zmanjša tveganje za zlome vretenc in kolka.
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). 
OSSEOR za vse podskupine pediatrične populacije pri osteoporozi (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
14 sachets 
14 vrečk
TROPOS involved 5,091 postmenopausal women with osteoporosis (low femoral neck BMD and prevalent fracture in more than half of them) and a mean age of 77 years. 
V študijo TROPOS so vključili 5091 žensk z osteoporozo v obdobju po menopavzi (nizko mineralno kostno gostoto v vratu stegnenice in obstoječimi zlomi pri več kot polovici) in srednjo starostjo 77 let.