natgillin/translations-raw huggingface dataset:
Anti-OP-1 antibodies have the ability to neutralize the in vitro biological activity of at least BMP-6.
Protitelesa proti OP- 1 lahko in vitro nevtralizirajo biološko aktivnost vsaj beljakovine BMP- 6.
Therefore, upon re- administration of Osigraft, a risk of developing autoimmunity towards the endogenous BMP proteins may exit.
Zato ob ponovni uporabi zdravila Osigraft obstaja tveganje za nastanek avtoimunosti proti endogenim beljakovinam BMP.
Pregnancy and breast-feeding Osigraft should not be used during pregnancy unless the benefits outweigh the risks to the foetus.
Nosečnost in dojenje Zdravilo Osigraft se ne sme uporabljati med nosečnostjo, razen kadar koristi odtehtajo tveganje za plod.
Women of child-bearing potential should inform their surgeon of the possibility of pregnancy prior to treatment with Osigraft.
Ženske v rodni dobi morajo pred zdravljenjem z zdravilom Osigraft obvestiti zdravnika o možni zanositvi.
Do not breast-feed your baby during Osigraft therapy.
Med zdravljenjem z zdravilom Osigraft ne dojite.
In animal studies, excretion of IgG class anti- OP-1 antibodies into milk has been shown.
V študijah na živalih so pokazali, da se protitelesa razreda IgG proti OP- 1 izločajo v mleko.
As human IgG is secreted into human milk, and the potential for harm to the infant is unknown, women should not breast-feed during Osigraft therapy.
Pri človeku se protitelesa IgG izločajo v mleko, morebitno tveganje za dojenčka pa je neznano, zato ženske med zdravljenjem z zdravilom Osigfraft ne smejo dojiti.
If you are nursing you should use Osigraft only if your treating physician considers the benefits outweigh the risks.
Če dojite, lahko uporabljate Osigraft samo, če lečeči zdravnik oceni, da koristi zdravljenja odtehtajo tveganje.
Driving and using machines Not relevant
Vpliv na sposobnost upravljanja vozil in strojev Podatek ni potreben
Important information about some of the ingredients of Osigraft Do not use Osigraft if you have a known hypersensitivity to collagen.
Pomembne informacije o nekaterih sestavinah zdravila Osigraft Zdravila Osigraft ne uporabljajte, če imate znano preobčutljivost za kolegen
HOW TO USE OSIGRAFT
KAKO UPORABLJATI ZDRAVILO OSIGRAFT
18 Treatment requires a single surgery.
Zdravljenje zahteva eno samo operacijo.
Depending on the size of the defect (gap of bone break), more than a single 1g unit of Osigraft may be required.
Morda bo potrebna več kot ena viala Osigrafta, odvisno od velikosti poškodbe (razpoke ali zloma kosti).
The maximum human dose should not exceed 2 vials (2g) since its effectiveness in the treatment on non-unions with gaps requiring higher doses has not been established.
Največji odmerek pri človeku ne sme presegati 2 viali, ker učinkovitost zdravljenja na nezrasle zlome z razpokami, za katere so potrebni višji odmerki, ni bila potrjena.
Osigraft is administered by your doctor during your surgery.
18 Osigraft daje zdravnik med kirurškim posegom.
It is placed directly at the defect (injury) site in contact with the prepared bone surface.
Nanaša se neposredno na mesto poškodbe, na vnaprej pripravljeno površino kosti.
The surrounding soft tissues (muscle and skin) are then closed around the implant.
Nato se okrog vsadka zaprejo obkostna mehka tkiva (mišice in koža).
You will be asleep during this procedure.
Med postopkom bolnik spi.
The following are directions for the use of Osigraft by your doctor.
V nadaljevanju so navodila za uporabo Osigrafta za vašega zdravnika.
Using sterile technique, remove the vial from its packaging.
Vialo sterilno vzemite iz ovojnine.
Aligning your thumb with the internal gap of the stopper, pry up the edge of the stopper.
Ko sprostite vakuum, odstranite zamašek viale.
Once the vacuum is broken, remove the vial stopper while holding the vial upright to prevent loss of product.
Vialo pri tem držite pokonci, da bi preprečili izgubo zdravila.
Puncture of the stopper with a needle may result in particles of stopper material contaminating Osigraft.
Če zamašek prebodete z iglo, lahko delci zamaška kontaminirajo Osigraft.
Reconstitute Osigraft with 2 to 3 ml of sterile 9 mg/ ml sodium chloride solution for injection (0.9% w/ v) prior to use.
Osigraft rekonstituirajte z 2 - do 3 ml sterilne 9 mg/ ml raztopine natrijevega klorida za injiciranje (0, 9% m/ v).
Once the implant is prepared it should be used immediately.
Vsadek morate uporabiti takoj, ko ga pripravite.
When reconstituted, Osigraft has the consistency of wet sand, which facilitates its implantation and placement at bone site defects.
Po rekonstituciji ima Osigraft teksturo mokrega peska, kar olajša vsaditev in namestitev na mestu poškodbe kosti.
Any unused Osigraft should be disposed together with surgical waste in accordance with local requirements.
Ves neporabljen Osigraft je treba skupaj s kirurškimi odpadki odstraniti v skladu z nacionalnimi zahtevami.
Debride fibrous, necrotic or sclerotic tissue and appropriately decorticate bone so that Osigraft is in direct contact with bleeding bone and viable osseous tissue.
Odstranite fibrozno, nekrotično ali sklerotično tkivo in ustrezno oluščite kost, tako da je Osigraft v neposrednem stiku s krvavečo kostjo in živim kostnim tkivom.
Provide adequate haemostasis to ensure that material is not dislodged from the surgical site.
Poskrbite za ustrezno preprečitev krvavenja in tako zagotovite, da material ostane na mestu operacije.
Where practical, surgical manipulations to the site should be completed prior to product implantation.
Če je mogoče, zaključite kirurške posege na tem mestu pred vsaditvijo.
Apply Osigraft to the prepared osseous tissue site using a sterile instrument such as a spatula or curette.
Nanesite Osigraft na pripravljeno mesto v kostnem tkivu s sterilnim instrumentom, na primer spatulo ali žličko.
Closure is critical for containment of the implant in the area of the defect.
Zaprtje teh tkiv je pomembno za zadrževanje vsadka v območju poškodbe.
After closure of the soft tissues around the defect, irrigate field, if necessary to remove any product, which may have become dislodged during soft tissue closure.
Ko so mehka tkiva v okolici poškodbe zaprta, jih po potrebi izperite in odstranite ostanke zdravila, ki so morda nabrali med zapiranjem.
Administration of Osigraft requires surgery.
19 Uporaba Osigrafta zahteva kirurški poseg.
Adverse events following such surgery and not specifically associated with the product may include wound infection, osteomyelitis (infection of the bone), complications of mechanical support (such as the metal rod or plate used for stabilisation), bleeding at the wound site, failure of the wound to heal, nausea, fever and pain.
Med neželene učinke po takem kirurškem posegu, ki niso povezani s tem zdravilom, lahko spadajo okužba rane, osteomielitis (okužba kosti), zapleti mehanske opore (na primer kovinske palice ali plošče, uporabljene za učvrstitev), krvavitev na mestu rane, neceljenje rane, slabost, vročina in bolečine.
The incidence of these events in clinical studies was > 10%.
Pogostnost teh pojavov je bila v kliničnih raziskavah večja od 10%.
However, there were no differences in the incidence of these adverse events compared with patients who received bone autograft (transplanted bone) instead of Osigraft, except in the case of osteomyelitis (infection of the bone) for which the incidence of osteomyelitis was statistically higher in the autograft group.
Vendar ni bilo razlike v pogostnosti navedenih neželenih učinkov v primerjavi z bolniki, pri katerih so namesto vsaditve Osigrafta opravili avtologno presajanje (presajanje kosti), razen osteomielitisa (okužbe kosti), ki je bil statistično pogostejši pri skupini bolnikov, zdravljenih z avtolognim presajanjem.
In clinical studies, the following undesirable effects have been reported as related to Osigraft discoloration of the wound site, erythema (redness of the skin), tenderness, and swelling over the implant site, and heterotopic ossification / myositis ossificans (bone formation outside of the fracture area).
V kliničnih raziskavah so poročali o naslednjih neželenih učinkih v zvezi z Osigraftom: razbarvanje mesta rane, eritem (rdečica kože), občutljivost, zatekanje na mestu vsadka in heterotopična okostenitev/ myositis ossificans (tvorba kosti zunaj mesta zloma).
None of these events were classified as serious.
Noben izmed teh učinkov ni opredeljen kot resen.
Store in a refrigerator at (2°C - 8°C) Keep the blister pack in the outer carton
Vsebnik shranjujte v zunanji ovojnini
Any unused product or waste material should be disposed of in accordance with local requirements
Vse neporabljeno zdravilo ali odpadne snovi, ki nastanejo iz teh zdravil, je treba odstraniti v skladu z nacionalnimi zahtevami.
Do not use after the expiry date which is stated on the label.
Zdravila Osigraft ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na ovojnini.
What Osigraft contains The active substance is eptotermin alfa (3.3 mg in 1 g of powder), produced by recombinant DNA technology in Chinese Hamster Ovary (CHO) cells.
Kaj vsebuje zdravilo Osigraft Zdravilna učinkovina je eptotermin alfa (3, 3 mg v 1 g praška), pridobljen iz celic jajčnikov kitajskega hrčka (Chinese Hamster Ovary – CHO) s tehnologijo rekombinantne DNA.
The other ingredient is vacuum dried bovine collagen, (1 g of powder in a vial).
Pomožna snov je vakuumsko posušen goveji kolagen (1 g praška na vialo).
What Osigraft looks like and contents of the pack Osigraft is supplied as white to off-white powder packaged in an amber colored glass vial (pack size of 1) within a blister pack, comprised of a plastic tray and lid, in a carton.
Izgled zdravila Osigraft in vsebina pakiranja Osigraft je na voljo v obliki belega do belkastega praška, pakiranega v rumeni stekleni viali (velikost pakiranja je 1) znotraj pretisnega ovoja, ki je sestavljen iz plastičnega podstavka in pokrova, v škatli.
Marketing Authorisation Holder and Manufacturer Howmedica International S. de R.
Imetnik dovoljenja za promet z zdravilom in izdelovalec Howmedica International S. de R.
20 This leaflet was last approved in {MM/ YYYY}.
Navodilo je bilo odobreno {MM/ LLLL}
Detailed information on this medicine is available on the European Medicines Agency (EMEA) web site: http: / /www. emea. europa. eu
20 Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila (EMEA) http: // www. emea. europa. eu
What is OSSEOR?
Kaj je zdravilo OSSEOR?
OSSEOR is a medicine containing the active substance strontium ranelate.
OSSEOR je zdravilo, ki vsebuje zdravilno učinkovino stroncijev ranelat.
It is available as 2-g sachets containing yellow granules, which are made up into an oral suspension.
Na voljo je v 2 g vrečkah, ki vsebujejo rumena zrnca za pripravo peroralne raztopine.
What is OSSEOR used for?
Za kaj se zdravilo OSSEOR uporablja?
OSSEOR is used to treat osteoporosis (a disease that makes bones fragile) in postmenopausal women to reduce the risk of vertebral (spine) and hip fractures.
Zdravilo OSSEOR se uporablja za zdravljenje osteoporoze (bolezni, ki povzroča krhkost kosti) pri ženskah po menopavzi, in sicer za zmanjšanje tveganja za zlome vretenc (hrbtenice) in kolka.
How is OSSEOR used?
Kako se zdravilo OSSEOR uporablja?
OSSEOR is taken as one sachet once a day.
Zdravilo OSSEOR se jemlje v odmerku ene vrečke enkrat dnevno.
The contents of the sachet are made up into a suspension in a glass of water and drunk just after being prepared.
Vsebina vrečke se pripravi v obliki suspenzije v kozarcu vode in spije takoj po pripravi.
OSSEOR should be taken at least two hours after food, milk, milk products or calcium supplements, preferably at bedtime.
Zdravilo OSSEOR je treba jemati najmanj dve uri po zaužitju hrane, mleka, mlečnih izdelkov ali kalcijevih dodatkov, najbolje pred spanjem.
OSSEOR is intended for long-term use.
Zdravilo OSSEOR je namenjeno dolgoročnemu zdravljenju.
Patients should receive calcium or vitamin D supplements if they are not getting enough from their diet.
Bolniki morajo jemati tudi dodatke kalcija ali vitamina D, če slednjih ne dobivajo v zadostni količini s prehrano.
How does OSSEOR work?
Kako zdravilo OSSEOR deluje?
Osteoporosis happens when not enough new bone grows to replace the bone that is naturally broken down.
Do osteoporoze pride, ko se ne tvori več dovolj nove kostne mase, da bi nadomestila naravno razgradnjo kosti.
Gradually, the bones become thin and fragile, and more likely to break (fracture).
Kosti se tako postopoma redčijo in postajajo krhkejše ter posledično bolj lomljive (podvržene zlomom).
Osteoporosis is more common in women after the menopause, when the levels of the female hormone oestrogen fall.
Osteoporoza je pogostejša pri ženskah v obdobju po menopavzi, ko raven ženskega hormona estrogena upade.
The active substance in OSSEOR, strontium ranelate, acts on the bone structure.
Zdravilna učinkovina zdravila OSSEOR, stroncijev ranelat, učinkuje na strukturo kosti.
Once in the gut, strontium ranelate releases strontium, which is similar to calcium and, like calcium, is absorbed into the bone.
Ko stroncijev ranelat prispe v črevesje, sprošča stroncij, ki je podoben kalciju in se tako kot kalcij absorbira v kost.
The mechanism of action of strontium is not fully understood but it stimulates bone formation and reduces bone breakdown.
Mehanizem delovanja stroncija ni v celoti znan, vendar spodbuja tvorjenje kosti in zmanjšuje razgradnjo kosti.
How has OSSEOR been studied?
Kako je bilo zdravilo OSSEOR raziskano?
OSSEOR has been studied in almost 7,000 postmenopausal elderly women in two large studies.
Zdravilo OSSEOR so preučevali v dveh obsežnih študijah, ki so vključevale skoraj 7. 000 starejših žensk po menopavzi.
Nearly a quarter of the patients were over 80 years of age.
Skoraj četrtina bolnic je bila starejših od 80 let.
The first study included 1,649 women with osteoporosis who already had vertebral fractures and the second included over 5,000 women whose osteoporosis affected the hip region in the thighbone.
V prvo študijo je bilo vključenih 1. 649 žensk z osteoporozo, ki so že imele zlome vretenc, v drugo študijo pa več kot 5. 000 žensk z osteoporozo kolčnega predela stegnenice.
In both studies, the effects of OSSEOR were compared with those of placebo (a dummy treatment).
V obeh študijah so učinke zdravila OSSEOR primerjali z učinki placeba (zdravila brez zdravilne učinkovine).
The main measure of effectiveness was the proportion of patients who, over three years, developed a new vertebral (spine) fracture in the first study, or a new osteoporosis peripheral fracture (at any site other than the spine) in the second study.
Glavno merilo učinkovitosti v prvi študiji je bil delež bolnic, pri katerih je v treh letih prišlo do novega zloma vretenc (hrbtenice), v drugi študiji pa delež bolnic, pri katerih je prišlo do novega osteoporotičnega perifernega zloma (na katerem koli drugem mestu razen v hrbtenici).
(44-20) 74 18 84 00 Fax (44-20) 74 18 84 16 E-mail: mail@emea. europa. eu http: / /www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged What benefit has OSSEOR shown during the studies?
(44- 20) 74 18 84 00 Fax (44- 20) 74 18 84 16 E- mail: mail@ emea. europa. eu http: // www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged Kakšne koristi je zdravilo OSSEOR izkazalo med raziskavami?
In the first study, OSSEOR was more effective than placebo in reducing the risk of new vertebral fractures.
V prvi študiji je bilo zdravilo OSSEOR pri zmanjševanju tveganja za nove zlome vretenc učinkovitejše od placeba.
The risk was reduced by 41% over three years, with 21% of the 719 women who took OSSEOR developing a new vertebral fracture, compared with 33% of those 723 who took placebo.
Tveganje se je v treh letih zmanjšalo za 41%, pri čemer je do novega vretenčnega zloma prišlo pri 21% od 719 žensk, ki so jemale zdravilo OSSEOR, medtem ko je pri ženskah, ki so jemale placebo, do novega vretenčnega zloma prišlo pri 33% od 723 žensk.
Overall, the results of the second study taken alone were insufficient to demonstrate a benefit of OSSEOR in preventing peripheral fractures.
Gledano v celoti, rezultati druge študije niso zadostno dokazali koristnosti zdravila OSSEOR pri preprečevanju perifernih zlomov.
When looking only at women of 74 years of age or older with particularly weak thighbones, the results suggested a reduction of the risk of hip fractures with OSSEOR.
Če pa gledamo zgolj rezultate, dobljene pri ženskah, starih 74 let ali več, ki so imele posebno šibki stegnenici, je mogoče ugotoviti, da je zdravilo OSSEOR zmanjšalo tveganje za zlom kolka.
When looking at results of the two studies taken together, fewer women in the OSSEOR group developed peripheral osteoporosis fractures at any site (including the hip) than in the placebo group (331 out of 3,295 with OSSEOR compared with 389 out of 3,256 for placebo).
Na podlagi rezultatov obeh študij skupaj je mogoče ugotoviti, da je do perifernih osteoporotičnih zlomov na katerem koli mestu (vključno s kolkom) prišlo pri manj ženskah iz skupine, ki je jemala zdravilo OSSEOR, kot pri tistih iz skupine, ki je jemala placebo (331 izmed 3. 295 v skupini, ki je jemala zdravilo OSSEOR, v primerjavi s 389 izmed 3. 256 v skupini, ki je jemala placebo).
This showed that the risk of fracture is reduced.
To je pokazalo, da se je tveganje za nastanek zloma zmanjšalo.
What is the risk associated with OSSEOR?
Kakšna tveganja so povezana z zdravilom OSSEOR?
The most common side effects with OSSEOR (seen in between 1 and 10 patients in 100) are headache, nausea (feeling sick), diarrhoea, loose stools, dermatitis (skin reactions) and eczema (flaky skin rash).
Najpogostejši neželeni učinki zdravila OSSEOR (opaženi pri 1 do 10 bolnikih izmed 100) so glavobol, navzeja (slabost), driska, redko blato, dermatitis (kožne reakcije) in ekcemi (luskasti kožni izpuščaji).
For the full list of all side effects reported with OSSEOR, see the Package Leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila OSSEOR, glejte Navodilo za uporabo.
OSSEOR should not be used in people who may be hypersensitive (allergic) to strontium ranelate or any of the other ingredients.
Zdravila OSSEOR se ne sme uporabljati pri osebah, ki utegnejo biti preobčutljive za (alergične na) stroncijev ranelat ali katerokoli drugo sestavino zdravila.
Why has OSSEOR been approved?
Zakaj je bilo zdravilo OSSEOR odobreno?
The Committee for Medicinal Products for Human Use (CHMP) decided that OSSEOR’ s benefits are greater than its risks for the treatment of postmenopausal osteoporosis to reduce the risk of vertebral and hip fractures.
Odbor za zdravila za uporabo v humani medicini (CHMP) je odločil, da so koristi zdravila OSSEOR pri zdravljenju in preprečevanju osteoporoze po menopavzi z namenom zmanjšanja tveganja zlomov vretenc in kolka večje od z njim povezanih tveganj.
The Committee recommended that OSSEOR be given marketing authorisation.
Odbor je zato priporočil, da se za zdravilo OSSEOR odobri dovoljenje za promet.
Other information about OSSEOR:
Druge informacije o zdravilu OSSEOR:
The European Commission granted a marketing authorisation valid throughout the European Union to LES LABORATORIES SERVIER for OSSEOR on 21 September 2004.
Evropska komisija je dovoljenje za promet z zdravilom OSSEOR, veljavno po vsej Evropski uniji, odobrila družbi LES LABORATORIES SERVIER dne 21. septembra 2004.
The full EPAR for OSSEOR is available here.
Celotno Evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo OSSEOR je na voljo tukaj.
sachet (paper/ PE/ alu)
vrečka (papir/ PE/ alu)
Excipient: also contains 20 mg of aspartame (E951).
Pomožne snovi: vsebuje tudi 20 mg aspartama (E 951).
Treatment of postmenopausal osteoporosis to reduce the risk of vertebral and hip fractures (see section 5.1).
Zdravljenje pomenopavzne osteoporoze za zmanjševanje tveganja zlomov vretenc in kolka (glejte poglavje 5. 1).
The recommended daily dose is one 2 g sachet once daily by oral administration.
Priporočeni dnevni odmerek je ena vrečka po 2 g enkrat na dan peroralno.
Given the slow absorption, OSSEOR should be taken at bedtime, preferably at least two hours after eating (see sections 4.5 and 5.2).
Zaradi počasne absorpcije OSSEOR jemljemo pred spanjem, najbolje najmanj dve uri po obroku (glejte poglavji 4. 5 in 5. 2).
The granules in the sachets must be taken as a suspension in a glass of water.
Zrnca iz vrečke popijemo v obliki suspenzije v kozarcu vode.
Although in-use studies have demonstrated that strontium ranelate is stable in suspension for 24 hours after preparation, the suspension should be drunk immediately after being prepared.
Čeprav so študije dokazale, da je stroncijev ranelat v suspenziji stabilen še 24 ur po pripravi, jo moramo popiti takoj ko je pripravljena.
Patients treated with strontium ranelate should receive vitamin D and calcium supplements if dietary intake is inadequate.
Bolnice, ki jih zdravimo s stroncijevim ranelatom, morajo jemati pripravke vitamina D in kalcija, če je vnos s prehrano nezadosten.
Use in the elderly 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.
Starejše bolnice Učinkovitost in varnost stroncijevega ranelata so dokazali pri ženskah z osteoporozo v obdobju po menopavzi, v širokem razponu starosti (do 100 let ob vključitvi).
No dosage adjustment is required in relation to age.
Prilagajanje odmerka pri starejših bolnicah ni potrebno.
Use in renal impairment No dosage adjustment is required in patients with mild-to-moderate renal impairment (30-70 ml/ min creatinine clearance) (see section 5.2).
Bolnice z ledvičnim popuščanjem Za bolnice z blagim do zmernim ledvičnim popuščanjem (očistek kreatinina 30 do 70 ml/ min) odmerka ni treba prilagajati (glejte poglavje 5. 2).
Strontium ranelate is not recommended for patients with severe renal impairment (creatinine clearance below 30 ml/ min) (see sections 4.4 and 5.2).
Stroncijev ranelat ni priporočljiv za bolnice s hudim ledvičnim popuščanjem (očistek kreatinina pod 30 ml/ min) (glejte poglavji 4. 4 in 5. 2).
2 Use in hepatic impairment As strontium ranelate is not metabolised, no dosage adjustment is required in patients with hepatic impairment.
Bolnice z jetrnim popuščanjem Ker se stroncijev ranelat ne presnavlja, bolnicam z jetrnim popuščanjem odmerka ni treba prilagajati.
Use in children and adolescents OSSEOR is not recommended for use in children and adolescents due to a lack of data on safety and efficacy.
2 Otroci in mladostniki Zaradi pomanjkanja podatkov o varnosti in učinkovitosti uporaba zdravila OSSEOR pri otrocih in mladostnikih ni priporočljiva.
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).
Ker ni podatkov o varnosti za kost pri bolnikih s hudim ledvičnim popuščanjem, ki bi jemali stroncijev ranelat, OSSEOR ni priporočen pri bolnicah z očistkom kreatinina pod 30 ml/ min (glejte poglavje 5. 2).
In accordance with good medical practice, periodic assessment of renal function is recommended in patients with chronic renal impairment.
V skladu z dobro zdravniško prakso je pri bolnicah s kroničnim ledvičnim popuščanjem priporočljivo redno ocenjevati delovanje ledvic.
Continuation of treatment with OSSEOR in patients developing severe renal impairment should be considered on an individual basis.
Če se razvije hudo ledvično popuščanje, se o nadaljevanju zdravljenja z zdravilom OSSEOR odločamo pri vsaki bolnici posebej.
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).
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).