FrancophonIA/ELRC3.0 huggingface dataset:
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 lpompa protonika, dijuretiċi, digoxin u glikosidi tal-qalb, nitrati organiċi u mediċini oħra li jwessgħu lvini 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-beta-2 adrenoriċetturi, antikoagulanti li jittieħdu mill-ħalq, mediċini li jimpedixxu t-twaħħil tal-plejtlits, statins, fibrates u derivattivi tal-benzodiazepines.
English: Strontium ranelate is made up of 2 atoms of stable strontium and 1 molecule of ranelic acid, the organic part permitting the best compromise in terms of molecular weight, pharmacokinetics and acceptability of the medicinal product.
Maltese: Strontium ranelate huwa magħmul minn 2 atomi ta' strontium stabbli u molekula waħda ta' ranelic acid, il-parti organika tippermetti l-aħjar kompromess bejn il-piż molekulari, il-farmakokinetika u laċċettabilità tal-prodott mediċinali.
English: In pooled randomised placebo-controlled studies of post-menopausal osteoporotic patients, a significant increase of myocardial infarction has been observed in strontium ranelate treated patients as compared to placebo (1.7% versus 1.1 %), with a relative risk of 1.6 (95% CI = [1.07 ; 2.38]).
Maltese: Fi studji kkontrollati bi plaċebo randomizzati miġburin ta' pazjenti b'osteoporożi ta' wara l-menopawża, ġiet osservata żieda sinifikanti ta' infart mijokardijaku f'pazjenti kkurati bi strontium ranelate meta mqabbla ma' dawk fuq plaċebo (1.7% kontra 1.1 %), b'riskju relattiv ta' 1.6 (95% CI = [1.07 ; 2.38]).
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: Strontium renalate mhuwiex irrakkomandat f'pazjenti b'indeboliment sever tal-kliewi (eliminazzjoni talkreatinina inqas minn 30 ml/min) (ara sezzjonijiet 4.4 u 5.2).
English: Following episodes of overdoses during clinical trials (up to 4 g/day for a maximal duration of 147 days), no clinically relevant events were observed.
Maltese: Wara doża eċċessiva waqt studji kliniċi (sa 4 g/jum għal tul massimu ta' 147 jum), ma kien osservat lebda avveniment klinikament relevanti.
English: • Importance of regularly monitoring cardiovascular risk.
Maltese: • L-importanza li timmonitorja b'mod regolari r-riskji kardjovaskulari.
English: o Current or previous venous thromboembolic events (VTE), including deep vein thrombosis and pulmonary embolism.
Maltese: o Avvenimenti tromboemboliċi venużi (VTE) attwali jew preċedenti, inkluż trombożi filvini profondi u emboliżmu pulmonari.
English: INFORMATION IN BRAILLE OSSEOR 2 g
Maltese: OSSEOR 2 g
English: HLA-A*33:03 and HLA-B*58:01 alleles have been identified as potential genetic risk factors for strontium ranelate-associated SJS/TEN in Han Chinese patients from a retrospective, case-control, pharmacogenetic study.
Maltese: HLA-A*33:03 u HLA-B*58:01 ġew identifikati bħala fatturi ta' riskju ġenetiku potenzjali għal SJS/TEN assoċjata ma' strontium ranelate f'pazjenti Ċiniżi
English: In phase III studies, the annual incidence of venous thromboembolism (VTE) observed over 5 years was approximately 0.7%, with a relative risk of 1.4 (95% CI = [1.0 ; 2.0]) in strontium ranelate treated patients as compared to placebo (see section 4.4).
Maltese: III, l-inċidenza annwali ta' tromboemboliżmu venuż (VTE) osservat fuq 5 snin kien ta' madwar 0.7%, b'riskju relattiv ta' 1.4 (95% CI = [1.0 ; 2.0]) f'pazjenti kkurati bi strontium ranelate meta mqabbla ma' dawk fuq plaċebo (ara sezzjoni 4.4).
English: Together, SOTI and TROPOS enrolled 1,556 patients over 80 years at inclusion (23.1% of the study population).
Maltese: Flimkien f'SOTI u TROPOS ħadu sehem 1,556 pazjent ta' aktar minn 80 sena fil-bidu tal-istudju (23.1% tal-popolazzjoni fl-istudju).
English: Blood Creatine phosphokinase (CPK) increased a
Maltese: Creatine phosphokinase (CPK) jogħla fid demma §
English: Vomiting, abdominal pain, reflux, indigestion, constipation, flatulence, difficulty in sleeping, inflammation of the liver (hepatitis), swelling in limbs, bronchial hyperreactivity (symptoms include wheezing and shortness of breath and cough), increased level of a muscle enzyme (Creatine phosphokinase), increased levels of cholesterol.
Maltese: Remettar, uġigħ ta' żaqq, rifluss, indiġestjoni, stitikezza, gass, diffikultà biex torqod, infjammazzjoni talfwied (epatite), nefħa fil-ġogi, reattività eċċessiva tal-bronki (sintomi jinkludu tħarħir, qtugħ ta' nifs u sogħla), livell miżjud ta' enzimi tal-muskoli (Creatine phosphokinase), żieda fil-livelli ta' kolesterol.
English: The effective half-life of strontium is about 60 hours.
Maltese: Il-half-life ta' strontium hija ta' bejn wieħed u ieħor 60 siegħa.
English: Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) (see section
Maltese: Reazzjoni għall-Mediċina b'Esinofilja u b'Sintomi Sistemiċi (DRESS) (ara sezzjoni 4.4)#
English: Nausea, diarrhoea, headache, eczema, memory trouble, fainting fit, pins and needles, dizziness, vertigo.
Maltese: Dardir, dijarea, uġigħ ta' ras, ekżema, problemi fil-memorja, ħass ħażin, jorqdulek partijiet ta' ġismek, sturdament, vertiġni.
English: Each sachet also contains 20 mg of aspartame (E951).
Maltese: Kull qartas fih ukoll 20 mg aspartame (E951)
English: There is no pharmacokinetic data in patients with severe renal impairment (creatinine clearance below 30 ml/min).
Maltese: M'hemmx tagħrif farmakokinetiku f'pazjenti b'indeboliment tal-kliewi severi (eliminazzjoni tal-kreatinina inqas minn 30 ml/min).
English: Oral mucosal irritation (stomatitis and/or mouth ulceration)
Maltese: Irritazzjoni fil-mukuża tal-ħalq (stomatite u/jew ulċera tal-ħalq) Ħalq xott
English: Bronchial hyperreactivity
Maltese: Reattività eċċessiva tal-bronki
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 flassorbiment 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: 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: F'kull Stat Membru fejn OSSEOR jiġi kkummerċjalizzat, id-Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq (MAH) għandu jaqbel mal-Awtorità Kompetenti Nazzjonali fuq il-programm edukattiv finali.
English: Table 1: Incidence of patients with vertebral fracture and relative risk reduction Study
Maltese: Tabella 1: L-inċidenza ta' pazjenti bi ksur fis-sinsla u t-tnaqqis fir-riskju relattiv.
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: NAME OF THE MEDICINAL PRODUCT OSSEOR 2 g granules for oral suspension Strontium ranelate
Maltese: OSSEOR 2 g granijiet għal sospensjoni orali 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: III, li wrew l-effett kontra l-ksur bil-kura bi OSSEOR, il-medja mkejla ta' BMD mill-bażi żdiedet bejn wieħed u ieħor b'4% kull sena fil-lumbari talispina 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: 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 1).
English: Given the slow absorption, OSSEOR should be taken at bedtime, preferably at least two hours after eating (see sections 4.5 and 5.2).
Maltese: Minħabba li jiġi assorbit bil-mod, OSSEOR għandu jingħata qabel ir-raqda ta' billejl, preferibbilment mill-inqas sagħtejn wara l-ikel (ara sezzjonijiet 4.5 u 5.2).
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 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.
Maltese: L-ogħla riskju ta' okkorrenza ta' reazzjonijiet serji tal-ġilda jseħħ fl-ewwel ġimgħat tal-kura għassindromu ta' Stevens-Johnson u nekroliżi epidermali tossika u normalment madwar 3-6 ġimgħat għal DRESS.
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 fid-demm u fit-total tal-attività ta' alkaline phosphatase, mingħajr ebda konsegwenza klinika.
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: Reazzjonijiet tal-ġilda li huma ta' theddida għas-saħħa (is-sindromu ta' Stevens-Johnson (SJS), nekroliżi epidermali tossika (TEN) u raxx minħabba xi mediċina b'eosinofilja u sintomi sistemiċi (DRESS)) ġew irrapportati bl-użu ta' OSSEOR.
English: A higher incidence, although still rare, of hypersensitivity reactions including skin rash, SJS or TEN in patients of Asian origin has been reported (see section 4.8).
Maltese: Ġiet irrapportata inċidenza ogħla, għalkemm xorta rari, ta' reazzjonijiet ta' sensittività eċċessiva inkluż raxx tal-ġilda, SJS jew TEN f'pazjenti ta' oriġini Asjatika (ara sezzjoni 4.8).
English: OSSEOR contains aspartame, a source of phenylalanine, which may be harmful for people with phenylketonuria.
Maltese: Eċċipjenti OSSEOR għandu aspartame, sors ta' phenylalanine, li jista' jkun ta' ħsara f'nies b'phenylketonuria.
English: Patients with significant risk factors for cardiovascular events (e.g. hypertension, hyperlipidaemia, diabetes mellitus, smoking) should only be treated with strontium ranelate after careful consideration (see sections 4.3 and 4.8).
Maltese: Pazjenti b'fatturi ta' riskju sinifikanti għal episodji kardjovaskulari (eż. pressjoni għolja, lipidemija għolja, dijabete mellitus, tipjip) għandhom jiġu kkurati bi strontium ranelate wara kunsiderazzjoni birreqqa (ara sezzjonijiet 4.3 u 4.8).
English: Rare (may affect up to 1 in 1000 people):
Maltese: Rari (tista' taffettwa sa persuna 1 minn kull 1,000):
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. adenopatija, epatite, nefropatija interstizjali, mard tal-pulmun interstizjali), il-kura bi OSSEOR għandha titwaqqaf minnufih.
English: Where possible, screening for HLA-A*33:03 and HLA-B*58:01 alleles could be considered before starting treatment with OSSEOR in patients of Han Chinese origin.
Maltese: Fejn ikun possibbli, għandu jiġi kkunsidrat l-iskrinjar għall-alleli HLAA*33:03 u HLA-B*58:01 qabel il-bidu tal-kura bi OSSEOR f'pazjenti ta' oriġini Ċiniża Han.
English: The anti-fracture studies program of OSSEOR was made up of two placebo-controlled phase III studies: SOTI study and TROPOS study.
Maltese: III ikkontrollati bi plaċebo: Studju SOTI u studju TROPOS.
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 tal-ġenbejn (p<0.
English: − Signs of severe hypersensitivity reactions (DRESS): initially as flu-like symptoms and a rash on the face then an extended rash with a high temperature (uncommon), increased levels of liver enzymes seen in blood tests (uncommon) an increase in a type of white blood cell (eosinophilia) (rare) and enlarged lymph nodes (uncommon).
Maltese: − Reazzjonijiet severi ta' sensittività eċċessiva (DRESS): inizjlament bħala sintomi simili għallinfluwenza u raxx fuq il-wiċċ imbagħad raxx estiż b'temperatura għolja (mhux komuni), livelli miżjudin ta' enzimi fil-fwied li jidhru f'testijiet tad-demm (mhux komuni), żieda f'tip ta' ċelloli tad-demm bojod (esinofilja) (rari) u nodi tal-limfa minfuħin (mhux komuni).
English: In this group, over 3 years of treatment, OSSEOR reduced the risk of hip fracture by 36% relative to the placebo group (table 2).
Maltese: F'dan il-grupp, tul 3 snin ta' kura, OSSEOR naqqas ir-riskju ta' ksur tal-ġenb b'36% meta mqabbel mal-grupp bi plaċebo.
English: Serum transaminase increased (in association with hypersensitivity skin reactions)
Maltese: Żieda fit-transaminase tas-serum (flimkien ma' reazzjonijiet ta' sensittività eċċessiva tal-ġilda)
English: Bone marrow failure# Eosinophilia (in association with hypersensitivity skin reactions)
Maltese: Eosinofilja (flimkien ma' reazzjonijiet ta' sensittività eċċessiva tal-ġilda)
English: No dose adjustment is required in patients with mild-to-moderate renal impairment (30-70 ml/min creatinine clearance) (see sections 4.4 and
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 tal-kreatinina) (ara s-sezzjonijiet 4.4 u 5.2).
English: Abdominal pain Gastrointestinal pain Gastrooesophageal reflux Dyspepsia
Maltese: Il-professjonisti dwar il-kura tas-saħħa huma mitluba jirrappurtaw kwalunkwe reazzjoni avversa suspettata permezz tas-sistema ta' rappurtar nazzjonali imniżżla f'Appendiċi V.
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: * In Asian countries reported as rare # For adverse reaction not observed in clinical trials, the upper limit of the 95% confidence interval is not higher than 3/X with X representing the total sample size summed up across all relevant clinical trials and studies.
Maltese: Għal reazzjoni avversa mhux osservata fil-provi kliniċi, il-limitu ta' fuq tal-intervall ta' fiduċja ta' 95% mhuwiex ogħla minn 3/X b'X tirrappreżenta d-daqs tal-kampjun totali magħdud flimkien millprovi kliniċi u mill-istudji relevanti kollha.
English: Intake of strontium ranelate with calcium or food reduces the bioavailability of strontium by approximately 60-70%, compared with administration 3 hours after a meal.
Maltese: Jekk strontium ranelate jittieħed ma' kalċju jew malikel, dan inaqqas il-bijodisponibiltà ta' strontium bejn wieħed u ieħor b'60%-70% meta mqabbel malgħoti 3 sigħat wara l-ikel.
English: You should stop taking OSSEOR if you have to take oral tetracyclines such as doxycycline or quinolones such as ciprofloxacin (two types of antibiotics).
Maltese: Għandek tieqaf tieħu OSSEOR jekk ikollok bżonn tieħu tetracyclines bħal doxycycline jew quinolones bħal ciprofloxacin mill-ħalq (żewġ tipi ta' antibijotiċi).
English: In an a-posteriori analysis of patients from the pooled SOTI and TROPOS studies with baseline lumbar spine and / or femoral neck BMD in the osteopenic range and without prevalent fracture but with at least one additional risk factor for fracture (N=176), OSSEOR reduced the risk of a first vertebral fracture by 72% over 3 years (incidence of vertebral fracture 3.6% with strontium ranelate vs. 12.0% with placebo).
Maltese: F'analiżi posterjuri ta' pazjenti mill-istudji SOTI u TROPOS miġbura flimkien b'bażi lumbari tal-ispina u/jew tal-għonq tal-femur BMD fil-wisa' osteopenika u mingħajr ksur prevelanti iżda mill-inqas b'fattur ta' riskju addizjonali għall-ksur (N = 176), OSSEOR naqqas ir-riskju li jkun hemm l-ewwel ksur tassinsla b'72% tul 3 snin (inċidenza ta' ksur tas-sinsla 3.6% bi strontium ranelate vs.
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 talgħadam.
English: 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.
Maltese: Ħallat il-granijiet ġol-qartas bħala sospensjoni ma' tazza li fiha minimu ta' 30 ml (madwar terz ta' tazza standard) ta' ilma.
English: EU/1/04/287/005 84 sachets (3 packs of 28) EU/1/04/287/006 100 sachets
Maltese: EU/1/04/287/006 100 qartas
English: Other symptoms may be nausea/vomiting, sweating, shortness of breath, palpitations, (extreme) tiredness and/or dizziness.
Maltese: Sintomi oħrajn jistgħu jkunu dardir/rimettar, għaraq, qtugħ ta' nifs, palpitazzjonijiet, għeja (estrema) u/jew sturdament.
English: NAME OF THE MEDICINAL PRODUCT OSSEOR 2 g granules for oral suspension
Maltese: OSSEOR 2 g granijiet għal sospensjoni orali
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: PHARMACEUTICAL FORM Granules for oral suspension Yellow granules
Maltese: GĦAMLA FARMAĊEWTIKA Granijiet għal sospensjoni orali Granijiet sofor
English: 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
Maltese: Il-kejl tal-konċentrazzjoni ta' strontium f'bijopsiji tal-għadam mill-krest tal-ilju ta' pazjenti trattati sa 60 xahar bi strontium ranelate 2 g/jum jindikaw li l-konċentrazzjoni ta' strontium fl-għadam tista' tilħaq limitu wara bejn wieħed u ieħor 3 snin ta' kura.
English: 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.
Maltese: Jekk ikun hemm sintomi jew sinjali ta' SJS jew TEN (eż. raxx tal-ġilda progressiv spiss b'nuffati jew leżjonijiet mukożali) jew DRESS (eż. raxx, deni, esinofilja u involviment sistemiku (eż. adenopatija, epatite, nefropatija interstizjali, marda tal-pulmun interstizjali), il-kura bi
English: Nausea
Maltese: Ekżema
English: MARKETING AUTHORISATION NUMBER(S) EU/1/04/287/004 56 sachets
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/04/287/004 56 qartas
English: ElderlyPopulation pharmacokinetic data showed no relationship between age and apparent clearance of strontium in the target population.
Maltese: It-tagħrif farmakokinetiku fil-popolazzjoni ma wera l-ebda relazzjoni bejn l-età u l-eliminazzjoni apparenti ta' strontium fil-popolazzjoni indikata.
English: Potentially life-threatening skin rashes (Stevens-Johnson syndrome, toxic epidermal necrolysis and severe hypersensitivity reactions (DRESS)) have been reported with the use of OSSEOR.
Maltese: Reazzjonijiet tal-ġilda li jistgħu jkunu ta' theddida għas-saħħa (is-sindromu ta' Stevens-Johnson, nekroliżi epidermali tossika u reazzjonijiet severi dovuti ta' ipersensittività (DRESS)) ġew irrapportati bl-użu ta' OSSEOR.
English: Seizures, oral irritation (such as mouth ulcers and gum inflammation), hair loss, feeling confused, feeling unwell, dry mouth, skin irritation.
Maltese: Konvulżjonijiet, irritazzjoni orali (bħal ulċeri fil-ħalq u infjammazzjoni tal-ħanek), telf ta' xahar, tħossok konfuż/a, ma tħossokx tajjeb, ħalq xott, irritazzjoni tal-ġilda.
English: In postmenopausal women, strontium ranelate reduces the risk of fracture at the spine and at the hip.
Maltese: F'nisa wara l-menopawża, strontium ranelate inaqqas ir-riskju ta' ksur tal-vertebri u tal-ġenbejn.
English: Lymphadenopathy (in association with hypersensitivity skin reactions)
Maltese: Limfadenopatija (flimkien ma' reazzjonijiet ta' sensittività eċċessiva tal-ġilda)
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'
English: How to take OSSEOR
Maltese: Jekk tieqaf tieħu OSSEOR
English: Osteoporosis-therapy is usually required for a long period.
Maltese: Il-kura għallosteoporożi normalment tieħu fit-tul.
English: No evidence of clinical interactions or relevant increase of blood strontium levels with medicinal products expected to be commonly prescribed concomitantly with OSSEOR in the target population were found during clinical trials.
Maltese: Matul il-provi kliniċi, ma nstabet l-ebda evidenza ta' interazzjonijiet kliniċi jew ta' żieda relevanti fillivelli ta' strontium fid-demm ma' prodotti mediċinali mistennija li jingħataw b'mod komuni ma' OSSEOR fil-popolazzjoni fil-mira.