natgillin/translations-raw huggingface dataset:
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.
Strontium ranelate has no or negligible influence on the ability to drive and use machines.
4.7 Vpliv na sposobnost vožnje in upravljanja s stroji Stroncijev ranelat nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja s stroji.
An a-posteriori analysis was performed on a subgroup of patients from the TROPOS study of particular medical interest and at high-risk of fracture [defined by a femoral neck BMD T-score ≤3 SD (manufacturer's range corresponding to -2.4 SD using NHANES III) and an age ≥ 74 years (n=1,977, i.e. 40% of the TROPOS study population)].
Analizo a posteriori so izvedli tudi pri podskupini bolnic iz študije TROPOS, ki so bile zlasti medicinsko zanimive in imele veliko tveganje za zlome [opredeljeno kot MKG vratu stegnenice vrednost T ≤ -3 SD (izdelovalčev razpon je ustrezal -2,4 SD po merilih NHANES III - National Health and Nutrition Examination Survey III) in starost ≥ 74 let (n = 1977, se pravi 40 % populacije v študiji TROPOS)].
• Patient alert card
• Kartica z opozorili za bolnika
Use in patients with renal impairment
Uporaba pri bolnikih z ledvično okvaro
Paper/polyethylene/aluminium/polyethylene sachets.
6.5 Vrsta ovojnine in vsebina Vrečke iz papirja/polietilena/aluminija/polietilena.
In this group, over 3 years of treatment, OSSEOR reduced the risk of hip fracture by 36% relative to the placebo group (table 2).
Pri takšnih bolnicah je v 3 letih zdravljenja OSSEOR zmanjšal tveganje za zlome kolka za 36 % v primerjavi s placebom (preglednica 2).
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]).
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].
Do not use this medicine after the expiry date which is stated on the box and the sachet after EXP.
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.
As strontium ranelate is not metabolised, no dose adjustment is required in patients with hepatic impairment.
Bolniki z jetrno okvaro Ker se stroncijev ranelat ne presnavlja, bolnikom z jetrno okvaro odmerka ni treba prilagajati.
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.
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.
Do not take OSSEOR during pregnancy or when you are breastfeeding.
Nosečnost in dojenje Zdravila OSSEOR ne smete jemati med nosečnostjo ali če dojite.
However, it is recommended to drink the suspension immediately after preparation (see section 4.2) 6.4 Special precautions for storage
Vseeno je suspenzijo priporočljivo popiti takoj po pripravi (glejte poglavje 4.2).
• 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.
o bolnikih s pomembnimi dejavniki tveganja za srčno-žilne dogodke, kot so npr. arterijska hipertenzija, hiperlipidemija, sladkorna bolezen ali kajenje.
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)
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)
Non-clinical data revealed no special hazard for humans based on conventional studies of safety pharmacology, genotoxicity and carcinogenic potential.
Predklinični podatki na osnovi običajnih študij farmakološke varnosti, genotoksičnosti in kancerogenega potenciala ne kažejo posebnega tveganja za človeka.
- if you have high blood pressure not controlled by treatment.
- če imate neurejen zvišan krvni tlak.
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.
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),
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).
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.
SOTI involved 1,649 postmenopausal women with established osteoporosis (low lumbar BMD and prevalent vertebral fracture) and a mean age of 70 years.
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.
Therefore, administration of OSSEOR and such products should be separated by at least two hours (see section 5.2).
Zato je priporočljivo, da bolniki jemljejo OSSEOR najmanj dve uri po njihovem zaužitju (glejte poglavje 5.2).
Contents of the pack and other information
Shranjevanje zdravila OSSEOR Vsebina pakiranja in dodatne informacije
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).
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).
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).
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).
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
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,
Your doctor may advise you to take calcium and vitamin D supplements in addition to OSSEOR.
Zdravnik vam lahko poleg zdravila OSSEOR svetuje pripravke kalcija in vitamina D. Ne jemljite kalcijevih pripravkov pred spanjem hkrati z zdravilom OSSEOR.