FrancophonIA/ELRC3.0 huggingface dataset:
English: 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).
Maltese: III huma dawn li ġejjin bl-użu ta' din ilkonvenzjoni (frekwenza versus plaċebo): komuni ħafna (>1/10), komuni (>1/100, <1/10); mhux komuni (>1/1,000, <1/100); rari (>1,10,000, <1/1,000); rari ħafna (<1/10,000); mhux magħruf (ma tistax tittieħed stima mid-data disponibbli).
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 21/09/2004
Maltese: Data tal-ewwel awtorizzazzjoni: 21/09/2004
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).
Maltese: Pazjenti b'indeboliment tal-kliewi Strontium renalate mhuwiex irrakkomandat f'pazjenti b'indeboliment sever tal-kliewi (eliminazzjoni tal-kreatinina inqas minn 30 ml/min) (ara sezzjonijiet 4.4 u 5.2).
English: Mannitol (E421)
Maltese: Aspartame (E951) Maltodextrin Mannitol (E421)
English: Long-term safety has been evaluated in postmenopausal women with osteoporosis treated for up to 60 months with strontium ranelate 2 g/day (n=3,352) or placebo (n=3,317) in phase III studies.
Maltese: Is-sigurtà fit-tul ġiet studjata f'nisa wara l-menopawsa bl-osteoporożi li ngħataw kura sa 60 xahar bi strontium ranelate 2 g/jum (n = 3,352) jew plaċebo (n = 3,317) fi studji ta' fażi
English: België/Belgique/Belgien S.A. Servier Benelux N.V. Tel: +32 (0)2 529 43 11
Maltese: België/Belgique/Belgien S.A. Servier Benelux N.V.
English: Pharmacotherapeutic group: Drugs for the treatment of bone diseases - Other drugs affecting bone structure and mineralisation, ATC code: M05BX03
Maltese: Mediċini għall-kura ta' mard fl-għadam- Mediċini oħrajn li jaħdmu fuq l-istruttura u l-mineralizzazzjoni tal-għadam, Kodiċi ATC: M05BX03
English: When a VTE occurs, OSSEOR should be stopped.
Maltese: Meta jkun hemm VTE, OSSEOR għandu jitwaqqaf.
English: In each Member State where OSSEOR is marketed, the Marketing Authorisation Holder (MAH) shall agree the final educational programme with the National Competent Authority.
Maltese: Tqegħid fis-Suq (MAH) għandu jaqbel mal-Awtorità Kompetenti Nazzjonali fuq il-programm edukattiv finali.
English: The elimination of strontium is time and dose independent.
Maltese: L-eliminazzjoni ta' strontium hija indipendenti mill-ħin u mid-doża.
English: Treatment of postmenopausal osteoporosis:
Maltese: Kura ta' osteoporożi menopawsali:
English: Each sachet contains 2 g of strontium ranelate.
Maltese: Kull qartas fih 2 g strontium ranelate.
English: In phase III studies, which demonstrated the anti-fracture efficacy of OSSEOR treatment, measured mean BMD increased from baseline with OSSEOR by approximately 4% per year at the lumbar spine and 2% per year at the femoral neck, reaching 13% to 15% and 5% to 6% respectively after 3 years, depending on the study.
Maltese: OSSEOR, il-medja mkejla ta' BMD mill-bażi żdiedet bejn wieħed u ieħor b'4% kull sena fil-lumbari tal-ispina tad-dahar bi OSSEOR u b'2% kull sena fl-għonq tal-femur, u tilħaq 13% sa 15% u 5% sa 6% rispettivament wara 3 snin skont l-istudju.
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.
Maltese: Kien hemm tolleranza tajba fi studju kliniku fejn ġie studjat l-għoti ripetut ta' 4 g strontium ranelate kull ġurnata fuq firxa ta' 25 jum f'nisa b'saħħithom wara l-menopawsa.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each sachet contains 2 g strontium ranelate.
Maltese: o Sensittività eċċessiva għas-sustanza attiva (strontium ranelate) jew għal kwalunkwe wieħed mill-eċċipjenti.
English: 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.
Maltese: F'pazjenti b'indeboliment tal-kliewi minn ħafif għal moderat (30-70 ml/min eliminazzjoni talkreatinina), l-eliminazzjoni ta' strontium tonqos kif tonqos l-eliminazzjoni tal-kreatinina (bejn wieħed u ieħor jonqos b'30% tul il-medda ta' eliminazzjoni tal-kreatinina minn 30 sa 70 ml/min) u għaldaqstant iwassal għal żieda fil-livelli ta' strontium fil-plażma.
English: Nausea, diarrhoea, headache, skin irritation, memory troubles, fainting fit.
Maltese: Dardir, dijarea, uġigħ ta' ras u irritazzjoni fil-ġilda, problemi fil-memorja, ħass ħażin.
English: 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.
Maltese: TROPOS involva 5,091 mara ta' wara l-menopawsa b'osteoporożi (BMD fl-għonq tal-femur baxx u ksur prevelanti f'iżjed minn nofshom) u b'età medja ta' 77 sena.
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.
Maltese: nekroliżi epidermali tossika (TEN) u raxx minħabba xi mediċina b'eosinofilja u sintomi sistemiċi (DRESS)) ġew irrapportati bl-użu ta' OSSEOR.
English: 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).
Maltese: L-effikaċja ta' OSSEOR intweriet fi rġiel b'osteoporożi fi studju kkontrollat bi plaċebo, double-blind ta' sentejn b'analiżi ewlenija wara sena f'243 pazjent (popolazzjoni b'intenzjoni li tiġi kkurata, 161 pazjent ingħataw strontium ranelate) b'riskju għoli ta' ksur (età medja ta' 72.7 sena; valur tal punteġġ BMD T lumbari medju ta' -2.6; 28% tal-ksur vertebrali prevalenti).
English: The combined effects of strontium distribution in bone (see section 5.2) and increased X-ray absorption of strontium as compared to calcium, leads to an amplification of bone mineral density (BMD) measurement by dual-photon X-ray absorptiometry (DXA).
Maltese: L-effetti kkombinanti tad-distribuzzjoni ta' strontium fl-għadam (ara sezzjoni 5.2) u ż-żieda fl assorbiment tal-X-ray bi strontium kif imqabbel ma' kalċju, iwasslu għall-amplifikazzjoni fid-densità minerali tal-għadam (BMD) kif imkejla permezz ta' assorbimetrija tal-X-ray dual-photon (DXA).
English: 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.
Maltese: Dawn il-mediċini jinkludu: sustanzi antiinflammatorji mhux sterojdi (inkluż acetylsalicylic acid), anilides (bħal paracetamol), mediċini li jimblukkaw ir-riċetturi H2 u l-pompa protonika, dijuretiċi, digoxin u glikosidi tal-qalb, nitrati organiċi u mediċini oħra li jwessgħu l-vini f'mard tal-qalb, imblokkaturi tal-kanal tal-kalċju, imblokkaturi beta, mediċini li jimpedixxu l-ACE, mediċini li jaħdmu kontra l-angiotensin II, mediċini li jgħinu selettivament il-beta2 adrenoriċetturi, antikoagulanti li jittieħdu mill-ħalq, mediċini li jimpedixxu t-twaħħil tal-plejtlits,
English: 7 sachets
Maltese: 7 qratas
English: No dose adjustment is required in patients with mild-to-moderate renal impairment (30-70 ml/min creatinine clearance) (see section 5.2).
Maltese: Ma hemm bżonn ta' ebda tibdil fid doża f'pazjenti b'indeboliment tal-kliewi minn ftit sa moderat (30-70 ml/min ta' eliminazzjoni talkreatinina) (ara sezzjoni 5.2).
English: Pregnancy
Maltese: Paraesteżija
English: In phase III placebo-controlled studies, strontium ranelate treatment was associated with an increase in the annual incidence of venous thromboembolism (VTE), including pulmonary embolism (see section 4.8).
Maltese: III ikkontrollati bi plaċebo, il-kura bi strontium ranelate kienet assoċjata ma' żieda fl-inċidenza annwali ta' tromboemboliżmu tal-vini (VTE), inkluż emboliżmu fil-pulmun (ara sezzjoni 4.8).
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
Maltese: Remettar, uġigħ ta' żaqq, rifluss, indiġestjoni, stitikezza, gass, ħalq xott, partijiet tal-ġisem li jorqdulek, sturdament, vertigo, diffikultà biex torqod, infjammazzjoni tal-fwied (epatite), irritazzjoni fil-ħalq (bħal ulċeri fil-ħalq u infjammazjoni fil-ħanek), uġigħ fl-għadam, fil-muskoli u/jew fil-ġogi, bugħawwieġ, jaqa' x-xagħar, tnaqqis fil-produzzjoni ta' ċelloli tad-demm fil-mudullun, ħakk, urtikarja, infafet, anġjoedema (bħal nefħa fil-wiċċ, fl-ilsien jew fil-griżmejn, diffikultà biex tieħu nnifs jew biex tibla'), tħossok ma tiflaħx, nefħa fl-idejn u fis-saqajn, tħossok konfuż, reattività eċċessiva tal-bronki (sintomi jinkludu tħarħir, qtugħ ta' nifs u sogħla).
English: Other medicines and OSSEOR:
Maltese: Mediċini oħra u OSSEOR:
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.
Maltese: Il-konċentrazzjoni massima fil-plażma tintlaħaq 3-5 sigħat wara doża waħda ta' 2 g.
English: • Key signs and symptoms of myocardial infarction, VTE and serious skin reactions.
Maltese: • Sinjali u sintomi ewlenin ta' infart mijokardijaku, VTE u reazzjonijiet serji fuq il-ġilda.
English: 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.
Maltese: Minħabba l-effetti farmakoloġiċi ta' strontium ranelate, kien osservat tnaqqis żgħir fil-konċentrazzjoni fis-serum ta' kalċju u tal-ormoni parathyroid (PTH), żieda fil-konċentrazzjoni ta' phosphorus fiddemm u fit-total tal-attività ta' alkaline phosphatase, mingħajr ebda konsegwenza klinika.
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu
Maltese: Informazzjoni dettaljata dwar dan il-prodott mediċinali tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea għall-Mediċini http://www.ema.europa.eu
English: A number of risk factors are associated with postmenopausal osteoporosis including low bone mass, low bone mineral density, early menopause, a history of smoking and a family history of osteoporosis.
Maltese: Numru ta' fatturi ta' riskju huma assoċjati mal-osteoporożi menopawsali li jinkludu l-massa baxxa fl-għadam, densità minerali baxxa, menopawsa kmieni, storja ta' tipjip u storja tal-osteoporożi fil-familja.
English: Take the granules contained in the sachets as a suspension in a glass of water (see instructions below).
Maltese: ikkontrollati bi plaċebo: Studju SOTI u studju TROPOS.
English: PHARMACEUTICAL FORM Granules for oral suspension Yellow granules
Maltese: GĦAMLA FARMAĊEWTIKA Granijiet għal sospensjoni orali
English: Strontium excretion occurs via the kidneys and the gastrointestinal tract.
Maltese: L-eskrezzjoni ta' strontium isseħħ mill-kliewi u mill-passaġġ gastrointestinali.
English: Excipient with known effect: Each sachet also contains 20 mg of aspartame (E951).
Maltese: Kull qartas fih ukoll 20 mg aspartame (E951) Għal-lista kompluta ta' eċċipjenti, ara sezzjoni 6.1.
English: 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.
Maltese: Studji kliniċi in vivo dwar prodotti mediċinali oħra li ma jaqblux ma' dan il-prodott urew li t-teħid ta' aluminium u magnesium hydroxides sagħtejn qabel jew flimkien ma' strontium ranelate wasslu għal tnaqqis żgħir fl-assorbiment ta' strontium ranelate (tnaqqis ta' 20-25% AUC), filwaqt li l-assorbiment kważi ma ġie mfixkel xejn meta l-mediċina kontra l-aċidu fl-istonku ngħatat sagħtejn wara strontium ranelate.
English: o If symptoms or signs of Stevens-Johnson Syndrome (SJS), Toxic Epidermal Necrolysis (TEN) or Drug Rash with Eosinophilia and Systemic Symptoms (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.
Maltese: o Jekk ikun hemm preżenti sinjali jew sintomi tas-Sindromu ta' Stevens-Johnson (SJS), Nekroliżi Epidermali Tossika (TEN) jew Raxx dovut għall-Mediċina b'Esinofilja jew Sintomi Sistemiċi (DRESS) (eż. raxx, deni, esinofilja u invovliment sistemiku, eż.
English: Statistically significant increases in femoral neck BMD and total hip BMD (p<0,001) were observed after 12 months.
Maltese: Ġew osservati żidiet statistikament sinifikanti fil-BMD tal-għonq femorali u fil-BMD totali talġenbejn (p<0.
English: Due to its high polarity, the absorption, distribution and binding to plasma proteins of ranelic acid are low.
Maltese: Minħabba l-polarità għolja, l-assorbiment, id-distribuzzjoni u t-twaħħil mal-proteini tal-plażma ta' ranelic acid huma baxxi.
English: 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.
Maltese: OSSEOR huwa kontraindikat f'pazjenti bi storja fil-passat ta' avvenimenti tromboemboliċi fil-vini (ara sezzjoni 4.3) u għandu jintuża bil-galbu f'pazjenti b'riskju ta' VTE.
English: PHARMACEUTICAL FORM AND CONTENTS Granules for oral suspension.
Maltese: GĦAMLA FARMAĊEWTIKA U L-KONTENUT Granijiet għal sospensjoni orali.
English: Temporary or permanent immobilisation due to e.g. post-surgical recovery or prolonged bed rest.
Maltese: o Immobilizzazzjoni temporanja jew permanenti dovuta għal eż. rkupru wara kirurġija jew serħan fit-tul fuq sodda.
English: Patients with hepatic impairment
Maltese: Disturbi fis-sistema nervuża
English: Renal impairment
Maltese: Strontium ranelate
English: The safety and efficacy of OSSEOR in children aged below 18 years have not been established.
Maltese: Is-sigurtà u l-effikaċja ta' OSSEOR fit-tfal ta' inqas minn 18-il sena ma ġewx determinati s'issa.
English: If you suffer from phenylketonuria (a rare, hereditary disorder of the metabolism) talk to your doctor before you start to take this medicine.
Maltese: Jekk tbati minn phenylketonuria (marda rari tal-metaboliżmu, li tintiret) kellem lit-tabib tiegħek qabel ma tibda tieħu din il-mediċina.
English: Table 1: Incidence of patients with vertebral fracture and relative risk reduction Placebo
Maltese: Tabella 1: L-inċidenza ta' pazjenti bi ksur fis-sinsla u t-tnaqqis fir-riskju relattiv.
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.
Maltese: Flimkien mat-terapija (2 g/jum ta' strontium ranelate jew plaċebo), il pazjenti, matul iż-żewġ studji, ingħataw supplimenti adattati ta' kalċju u vitamina D.
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).
Maltese: F'pazjenti ta' aktar minn 80 sena meta daħlu fl-istudju, analiżi miġbura flimkien tal-istudji SOTI u TROPOS uriet li OSSEOR naqqas ir-riskju relattiv li wieħed isofri minn ksur ġdid tas-sinsla b'32% fuq 3 snin (inċidenza ta' 19.1% bi strontium ranelate vs. 26.
English: After approval of the protocol, annual reports from this study shall be provided within the PSUR until submission of the final study report, which is due by December 2017.
Maltese: Wara approvazzjoni tal-protokoll, ir-rapporti annwali minn dan l-istudju sejrin jiġu pprovduti fi ħdan il-PSUR sas-sottomissjoni tar-rapport ta' studju finali, li huwa dovut sa Diċembru 2017.
English: Frequency unknown:a Vomiting Abdominal pain Oral mucosal irritation (stomatitis and/or mouth ulceration) Gastrooesophageal reflux Dyspepsia Constipation Flatulence Dry mouth Hepatobiliary disorders Frequency unknown:a Serum transaminase increased (in association with hypersensitivity skin reactions) Hepatitis Skin and subcutaneous tissue disorders Common: Dermatitis Eczema Rare: DRESS (see section 4.4) Very rare: Severe cutaneous adverse reactions (SCARs): Stevens-Johnson syndrome and toxic epidermal necrolysisc (see section 4.4) Frequency unknown:a Hypersensitivity skin reactions (rash, pruritus, urticaria, angioedema) Alopecia Musculoskeletal and connective tissue disorders Frequency unknown:a Musculoskeletal pain (muscle spasm, myalgia, bone pain, arthralgia and pain in extremity) General disorders and administration site conditions Frequency unknown:a Peripheral oedema Pyrexia (in association with hypersensitivity skin reactions) Malaise Blood and Lymphatic disorders Frequency unknown:a Bone marrow failure Eosinophilia (in association with hypersensitivity skin reactions) Lymphadenopathy (in association with hypersensitivity skin reactions) Investigations Common: Blood Creatine phosphokinase (CPK) increasedb a Post-marketing experience b Musculo-skeletal fraction > 3 times the upper limit of the normal range.
Maltese: Ir-riskju ta' trombożi tal-vini (emboli tad-demm fis-saqajn jew fil-pulmuni) jista' jiżdied fil-każ ta' immobilizzazzjoni fit-tul. - jekk għandek mard iskemiku tal-qalb, jew mard ċerebrovaskulari, eż. ġejt iddijanjostikat/a b'attakk tal-qalb, puplesija, jew attakk iskemiku temporanju (tnaqqis temporanju tal-fluss tad demm għall-moħħ; magħruf ukoll bħala “riħ ta' puplesija”), anġina, jew imblokk tal-vini għallqalb jew għall-moħħ. - jekk għandek jew kellek problemi biċ-ċirkolazzjoni tad-demm tiegħek (mard arterjali periferali) jew jekk kellek kirurġija fuq l-arterji ta' riġlejk.
English: The most common adverse reactions consisted of nausea and diarrhoea, which were generally reported at the beginning of treatment with no noticeable difference between groups afterwards.
Maltese: L-iżjed reazzjonijiet avversi komuni kienu dardir u dijarea, li normalment ġew irrapportati fil-bidu tal-kura mingħajr ma kien hemm ebda differenza bejn il-gruppi wara.
English: OSSEOR reduced the relative risk of new vertebral fracture by 41% over 3 years in the SOTI study (table 1).
Maltese: OSSEOR naqqas ir-riskju relattiv ta' ksur ġdid fis-sinsla b'41% tul tliet snin fl-istudju SOTI (tabella
English: 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)].
Maltese: Analiżi a-posteriori twettqet fuq sottogrupp ta' pazjenti ta' interess mediku partikolari u b'riskju għoli ta' ksur [definit bħala BMD tal-għonq tal-femur T-score ≤ -3SD (il-wisa' tal-produttur tikkorispondi għal 2.4
English: In postmenopausal women, strontium ranelate reduces the risk of vertebral and hip fractures (see section
Maltese: F'nisa wara l-menopawża, strontium ranelate inaqqas ir-riskju ta' ksur tal-vertebri u tal-ġenbejn (ara sezzjoni
English: 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).
Maltese: OSSEOR f'kull sett tal-popolazzjoni pedjatrika b'osteoporożi (ara sezzjoni 4.2 għall-informazzjoni fuq l-użu pedjatriku)
English: Potentially life-threatening skin rashes (Stevens-Johnson syndrome, toxic epidermal necrolysis) have been reported (see section 2).
Maltese: Stevens-Johnson u nekroliżi epidermali tossikac (ara sezzjoni 4.4)
English: The binding of strontium to human plasma proteins is low (25%) and strontium has a high affinity for bone tissue.
Maltese: It-twaħħil ta' strontium malproteini tal-plażma tad-demm uman huwa baxx (25%) u strontium għandu affinità kbira għat-tessuti tal-għadam.
English: Table 2: Incidence of patients with hip fracture and relative risk reduction in patients with BMD ≤ -2.4 SD (NHANES III) and age ≥ 74 years
Maltese: Tabella 2: L-inċidenza ta' pazjenti bil-ksur tal-ġenb u t-tnaqqis fir-riskju relattiv tal-ksur f'pazjenti b'BMD ≤ -2.4
English: The activity of strontium ranelate was studied in various non-clinical models.
Maltese: L-attività ta'strontium ranelate ġiet studjata f'numru ta' mudelli mhux kliniċi.
English: Food, milk and derivative products, and medicinal products containing calcium may reduce the bioavailability of strontium ranelate by approximately 60-70%.
Maltese: L-ikel, il-ħalib u derivattivi tal-ħalib, u mediċini li fihom il-kalċju jistgħu jnaqqsu l-bijodisponibbiltà ta' strontium ranelate bejn wieħed u ieħor 60%-70%.
English: Non-interventional safety study to evaluate the effectiveness of the applied risk minimisation measures, including a description of the treated patient population in everyday clinical practice, patterns of use and cardiovascular risk.
Maltese: Studju tas-sigurtà mingħajr intervent sabiex jevalwa l-effikaċja tal-miżuri ta' minimizzazzjoni tarriskji applikati, inkluż deskrizzjoni tal-popolazzjoni tal-pazjenti kkurati, b'mod ta' użu ta' prattika klinika ta' kuljum u b'riskju kardjovaskulari.
English: The MAH shall ensure that, following discussion and agreement with the National Competent Authority in each Member State where OSSEOR is marketed, all physicians who are expected to prescribe OSSEOR are provided with the following educational package:
Maltese: Il-MAH għandu jiżgura li, wara diskussjoni u ftehim mal-Awtorità Nazzjonali Kompetenti f'kull Stat Membru fejn OSSEOR jiġi kkummerċjalizzat, it-tobba kollha li huma mistennija li jagħtu OSSEOR jiġu pprovduti bil-pakkett edukattiv li ġej:
English: In phase III studies, as compared to placebo, biochemical markers of bone formation (bone-specific alkaline phosphatase and C-terminal propeptide of type I procollagen) increased and those of bone resorption (serum C-telopeptide and urinary N-telopeptide cross links) decreased from the third month of treatment up to 3 years.
Maltese: III, meta mqabblin ma' plaċebo, il-markaturi bijokimiċi tal-formazzjoni tal-għadam (alkaline phospatase speċifiku għall-għadam u C-terminal propeptide tat-tip I procollagen) żdiedu u dawk ta' riassorbiment tal-għadam (serum C-telopeptide u N-telopeptide magħqudin imsallbin fl awrina) naqsu mit-tielet xahar tal-kura sat-tielet sena.
English: Strontium ranelate does not present a risk for the environment.
Maltese: strontium ranelate inaqqas ir-riskju ta' ksur tal-vertebri u tal-ġenbejn.
English: Tel: +48 (0) 22 594 90 00
Maltese: Servier Polska Sp. z o.o. Tel: +48 (0) 22 594 90 00