FrancophonIA/ELRC3.0 huggingface dataset:
English: In all reported cases, intracranial hypertension associated signs and symptoms resolved after reduction of the NutropinAq dose or termination of therapy (see section 4.4).
Maltese: Fil-każijiet kollha rrappurtati, sinjali u sintomi assoċjati ma' pressjoni għolja fil-kranju għaddew wara tnaqqis tad-doża ta' NutropinAq jew waqfien tat-terapija (ara sezzjoni 4.4).
English: NutropinAq therapy must not be initiated when there is evidence of tumour activity.
Maltese: Terapija b'NutropinAq m'għandhiex tinbeda meta jkun hemm evidenza ta' attività tat-tumur.
English: Low initial doses of 0.15 - 0.3 mg injected each day under the skin (subcutaneous injection).
Maltese: Dożi baxxi tal-bidu ta' 0.15 - 0.3 mg injettati kuljum taħt il-ġilda (injezzjoni taħt il-ġilda).
English: Limited published data indicate that growth hormone treatment increases cytochrome P450 mediated antipyrine clearance in man.
Maltese: Data limitata ppubblikata tindika li kura bl-ormon tat-tkabbir iżżid it-tneħħija ta' antipyrine medjata miċ-ċitokromju P450 fil-bniedem.
English: As NutropinAq may reduce insulin sensitivity, patients should be monitored for evidence of glucose intolerance.
Maltese: Peress li NutropinAq jista' jnaqqas is-sensittività għall-insulina, il-pazjenti għandhom jiġu ssorveljati għall-evidenza ta' intolleranza għall-glucose.
English: If a woman taking NutropinAq begins oral oestrogen therapy, the dose of NutropinAq may need to be increased to maintain the serum IGF-1 levels within the normal age appropriate range.
Maltese: Jekk mara li qed tieħu NutropinAq tibda terapija ta' estroġeni orali, jista' jkun li d-doża ta' NutropinAq ikollha tiżdied biex il-livelli ta' IGF-1 fis-serum jinżammu fil-firxa normali adatta għalletà.
English: Patients received an s.c. dose of 0.125 mg/kg three times a week or 0.054 mg/kg/day, both regimens giving a cumulative weekly dose of approximately 0.375 mg/kg.
Maltese: Pazjenti rċevew doża s.c. ta' 0.125 mg/kg tliet darbiet fil-ġimgħa jew 0.054 mg/kg/jum, biżżewġ korsijiet jagħtu doża kumulattiva ta' kull ġimgħa ta' madwar 0.375 mg/kg.
English: 3 cartridges containing 2 ml solution for injection
Maltese: GĦAMLA FARMAĊEWTIKA U KONTENUT 3 skrataċ li fihom 2 ml ta' soluzzjoni għall-injezzjoni
English: Swelling of the hands and feet due to an accumulation of fluid (peripheral oedema) sometimes associated with localised muscle pain (myalgia) and pain in joints (arthralgia).
Maltese: Nefħa tal-idejn u tas-saqajn ikkawżata minn akkumulazzjoni ta' fluwidu (edima periferali) kultant assoċjata ma' wġigħ lokalizzat fil-muskoli (majalġja) u wġigħ fil-ġogi (artralġja).
English: Paediatric population Available literature data suggests that somatropin clearances are similar in adults and children.
Maltese: Data disponibbli fil-letteratura tissuġġerixxi li t-tneħħija ta' somatropin hija simili fl-adulti u fit-tfal.
English: The most common adverse events (AEs) observed in the pivotal studies were infection, headache, otitis media, fever, pharyngitis, rhinitis and gastroenteritis and vomiting.
Maltese: L-aktar avvenimenti avversi (AEs - adverse events) komuni osservati fl-istudji pivitali kienu infezzjoni, uġigħ ta' ras, otite medja, deni, farinġite, rinite u gastroenterite u rimettar.
English: In addition, patients treated with glucocortocoid replacement therapy for previously diagnosed hypoadrenalism may require an increase in their maintenance or stress doses, following initiation of somatropin treatment (see section 4.4).
Maltese: Barra dan, pazjenti kkurati b'terapija ta' sostituzzjoni ta' glukokortikojdi għal ipoadrenaliżmu mhux iddijanjostikat minn qabel għandhom imnejn ikunu jeħtieġu żieda fid-dożi ta' manteniment jew ta' stress tagħhom, wara bidu ta' kura b'somatropin (ara sezzjoni 4.4).
English: Abnormal sensations of tingling, pricking or numbness (paraesthesia), abnormal bone development, disease affecting progress of bone growth (osteochondrosis) and muscle weakness.
Maltese: Sensazzjonijiet mhux normali ta' tnemnim, tingiż jew tirżiħ (parasteżija), żvilupp mhux normali talgħadam, marda li għandha effett fuq it-tkabbir tal-għadam (osteokondrosi) u dgħjufija fil-muskoli.
English: Growth failure in children due to inadequate growth hormone secretion 0.025 - 0.035 mg/kg bodyweight given as a daily subcutaneous injection.
Maltese: Falliment tat-tkabbir fit-tfal ikkawżat minn sekrezzjoni inadegwata tal-ormon tat-tkabbir 0.025 - 0.035 mg/kg ta' piż tal-ġisem mogħtija bħala injezzjoni taħt il-ġilda kuljum.
English: Very common in adults, common in children: Arthralgia, myalgia Uncommon: Muscle atrophy, bone pain
Maltese: Komuni ħafna f'persuni adulti, komuni fit-tfal: Artralġja, mijalġja
English: Glucocorticoids use
Maltese: Tkabbir tat-Tessuti
English: EXP: {date} After first opening, use before 28 days at 2°C - 8°C.
Maltese: Wara l-ewwel użu, l-iskartoċċ jista' jiġi maħżun għal mhux aktar minn 28 ġurnata f'temperatura ta' 2°C - 8°C.
English: Increase in blood sugar levels (hyperglycaemia, diabetes mellitus).
Maltese: Żieda fil-livelli ta' zokkor fid-demm (ipergliċemija, dijabete mellitus).
English: Hepatic impairment
Maltese: Ipertrofija taladenojdi
English: Common: hyperglycaemia, hyperlipidaemia, insomnia, synovial disorder, arthrosis, muscular weakness, back pain, breast pain, gynaecomastia.
Maltese: Komuni: ipergliċemija, iperlipidemija, nuqqas ta' rqad, disturb fil-fluwidu sinovjali, artrożi, dgħufija fil-muskoli, uġigħ fid-dahar, uġigħ fis-sider, żvilupp eċċessiv tas-sider fir-raġel.
English: 6 times (0.6 mg) to remove air bubbles.
Maltese: darbiet (0.6 mg) biex tneħħi l-bżieżaq tal-arja.
English: • Clean the cartridge rubber seal with an alcohol swab or cotton ball saturated with alcohol.
Maltese: • Jekk bi żball missejt is-siġill tal-lasktu tal-iskartoċċ, naddfu b'imselħa tal-alkoħol.
English: Children treated with somatropin have an increased risk of developing pancreatitis compared to adults treated with somatropin.
Maltese: Tfal ikkurati b'somatropin għandhom żieda fir-riskju li jiżviluppaw pankreatite meta mqabbla ma' persuni adulti kkurati b'somatropin.
English: EXP: {date}
Maltese: Tel.:
English: Supportive data are provided by two other studies, in which patients were given a dose of 0.3 or 0.6 mg/kg/week either as a daily injection or three times per week, or 0.029 mg/kg/day.
Maltese: Data ta' appoġġ hija pprovduta minn żewġ studji oħra, fejn il-pazjenti ngħataw doża ta' 0.3 jew 0.6 mg/kg/ġimgħa bħala injezzjoni ta' kuljum jew tliet darbiet fil-ġimgħa, jew 0.029 mg/kg/jum.
English: Personality changes or abnormal behaviour.
Maltese: Bidliet fil-personalità jew imġiba mhux normali.
English: Children with chronic renal insufficiency commonly reported inflammation of the lining of the abdomen (peritonitis), bone necrosis and an increase of creatinine blood levels.
Maltese: Tfal b'insuffiċjenza kronika tal-kliewi rrappurtaw b'mod komuni infjammazzjoni tal-kisja tal-addome (peritonite), nekrosi tal-għadam u żieda fil-livelli ta' krejatinina fid-demm.
English: Glycaemic control
Maltese: 4.1 Indikazzjonijiet terapewtiċi
English: In children, NutropinAq is used:
Maltese: Fit-tfal, NutropinAq jintuża:
English: Events of diabetes mellitus and hyperglycaemia were reported in the post-marketing surveillance survey (see section 4.4).
Maltese: Studji fuq l-annimali mhumiex biżżejjed rigward l-effett tossiku fuq is-sistema riproduttiva (ara sezzjoni 5.3).
English: 6 cartridges containing 2 ml solution for injection
Maltese: GĦAMLA FARMAĊEWTIKA U KONTENUT 6 skrataċ li fihom 2 ml ta' soluzzjoni għall-injezzjoni
English: In children with growth hormone deficiency: 0.025 - 0.035 mg/kg bodyweight injected each day under the skin (subcutaneous injection).
Maltese: Fi tfal b'defiċjenza tal-ormon tat-tkabbir: 0.025 - 0.035 mg/kg ta' piż tal-ġisem injettata kuljum taħt il-ġilda (injezzjoni taħt il-ġilda).
English: Ipsen Pharma Lietuvos filialas T. Narbuto g. 5, LT-08105 Vilnius Tel. +370 700 33305
Maltese: Ipsen Pharma Lietuvos filialas T. Narbuto g. 5
English: Uncommon: Exfoliative dermatitis, skin atrophy, skin hypertrophy, hirsutism, lipodystrophy, urticaria
Maltese: Żvilupp mhux normali talgħadam, osteokondrosi, dgħufija filmuskoli, uġigħ fl-estremitajiet
English: Common: Drug specific antibody present
Maltese: Komuni: Antikorp speċifiku għall-mediċina preżenti
English: In total, 128 patients received somatropin over the 24 month controlled phase of the 2 studies, and 139 patients were treated with somatropin in the open extension phases.
Maltese: B'kollox, 128 pazjent irċevew somatropin fil-fażi kkontrollata ta' 24 xahar taż-żewg studji, u 139 pazjent kienu kkurati b'somatropin fil-fażijiet ta' estensjoni open label.
English: At the start of somatropin therapy, low initial doses of 0.15 - 0.3 mg are recommended, given as a daily subcutaneous injection.
Maltese: Fil-bidu tat-terapija b'somatropin, huma rrakkomandati dożi baxxi tal-bidu ta' 0.15 - 0.3 mg, mogħtija bħala injezzjoni taħt il-ġilda darba kuljum.
English: Taking into account the PRAC Assessment Report on the PSUR(s) for somatropin, the scientific conclusions of CHMP are as follows:
Maltese: Meta jiġi kkunsidrat ir-Rapport ta' Valutazzjoni tal-PRAC dwar il-PSUR(s) għal somatropin, ilkonklużjonijiet xjentifiċi tas-CHMP huma kif ġej:
English: Scoliosis
Maltese: Skoljosi
English: Some patients may develop antibodies (a type of protein produced by the body) to somatropin.
Maltese: Xi pazjenti jistgħu jiżviluppaw antikorpi (tip ta' proteina magħmula mill-ġisem) għal somatropin.
English: Intracranial hypertension with papilloedema, visual changes, headache, nausea and/or vomiting has been reported in a small number of patients treated with somatropin.
Maltese: Tipikament din hija assoċjata ma' papilloedima, tibdil fil-vista, uġigħ ta' ras, dardir, u/jew rimettar u s-sintomi ġeneralment iseħħu fi żmien tmien ġimgħat mill-bidu ta' terapija b'NutropinAq.
English: You should see a drop of solution appear.
Maltese: Għandek tara qatra ta' soluzzjoni tifforma.
English: Sensitive and dry skin (exfoliative dermatitis), changes in thickness of the skin, excessive growth of hair on the face and body (hirsutism), hives (urticaria).
Maltese: Ġilda sensittiva u xotta (dermatite bil-qxur), bidliet fil-ħxuna tal-ġilda, tkabbir eċċessiv ta' xagħar filwiċċ u l-ġisem (irsutiżmu), ħorriqija (urtikarja).
English: For each injection you should use a new sterile injection needle.
Maltese: Għal kull injezzjoni għandek tuża labra għall-injezzjoni sterili ġdida.
English: Each study had a two year treatment period which included a placebo arm, followed by an open label uncontrolled extension in which all patients received somatropin.
Maltese: Kull studju kellu perjodu ta' kura ta' sentejn li kien jinkludi grupp bil-plaċebo, segwit minn estensjoni open label mhux ikkontrollata fejn il-pazjenti kollha rċevew somatropin.
English: Δημητρίου 63 Άλιμος GR-17456 Αθήνα Ελλάδα Τηλ: + 30 - 210 - 984 3324
Maltese: Τηλ: + 30 - 210 - 984 3324
English: From a microbiological point of view, once opened, the product may be stored for a maximum of 28 days at 2°C - 8°C.
Maltese: Mil-lat mikrobijoloġiku, ladarba jinfetaħ, il-prodott jista' jinħażen sa massimu ta' 28 ġurnata f'temperatura ta' 2°C - 8°C.
English: Pain, bleeding, bruising, rash and itching at the site of injection.
Maltese: Uġigħ, fsada, tbenġil, raxx u ħakk fis-sit tal-injezzjoni.
English: Sodium Chloride Liquified Phenol Polysorbate 20
Maltese: Polysorbate 20
English: Conversely, if a woman on NutropinAq discontinues oral oestrogen therapy, the dose of NutropinAq may need to be reduced to avoid excess of growth hormone and/or side effects (see section 4.5).
Maltese: Kuntrarju għal dan, jekk mara fuq NutropinAq twaqqaf terapija ta' estroġeni orali, jista' jkun li ddoża ta' NutropinAq ikollha titnaqqas biex jiġi evitat li jkollha eċċess tal-ormon tat-tkabbir u/jew effetti sekondarji (ara sezzjoni 4.5).
English: No conventional reproduction studies were performed.
Maltese: Ma sarux studji konvenzjonali dwar ir-riproduzzjoni.
English: Always refer to the LCD (Liquid Crystal Display), not audible clicks, for setting an injection of NutropinAq.
Maltese: Dejjem irreferi għalLCD (Display ta' Kristalli Likwidi - Liquid Crystal Display), u mhux għaċ-ċekċik li jinstema', biex tipprepara injezzjoni ta' NutropinAq.
English: Acute overdose could lead to hyperglycaemia.
Maltese: Doża eċċessiva akuta tista' twassal għal ipergliċemija.
English: In adults with growth hormone deficiency:
Maltese: Bidu f'età adulta:
English: Localised loss/gain of fat from the skin (lipodystrophy, injection site atrophy/hypertrophy) Enlarged adenoids with similar symptoms as enlarged tonsils (see rare).
Maltese: Adenojdi mkabbra b'sintomi simili bħal tunsilli mkabbra (ara rari).
English: These measures will help to protect the environment.
Maltese: Il-Pinna NutropinAq tiegħek taħdem mingħajr il-protezzjonijiet.
English: Growth failure associated with chronic renal insufficiency Up to 0.05 mg/kg bodyweight given as a daily subcutaneous injection.
Maltese: Falliment tat-tkabbir assoċjat ma' insuffiċjenza kronika tal-kliewi Sa 0.05 mg/kg ta' piż tal-ġisem mogħtija bħala injezzjoni taħt il-ġilda kuljum.
English: • if you have a replacement therapy with glucocorticoids it may reduce the effect of NutropinAq on growth.
Maltese: • jekk għandek terapija ta' sostituzzjoni bi glukokortikojdi din tista' tnaqqas l-effett ta' NutropinAq fuq it-tkabbir.
English: Vascular disorders
Maltese: Kontroll taz-zokkor
English: A: Yes.
Maltese: JIS: {data}
English: A causal relationship to somatropin therapy has not been established.
Maltese: Relazzjoni kawżali għal terapija b'somatropin ma ġietx stabbilita.
English: Long-term overdose could result in signs and symptoms of gigantism and/or acromegaly consistent with the known effects of excess growth hormone.
Maltese: Doża eċċessiva fit-tul tista' twassal għal sinjali u sintomi ta' ġigantiżmu u/jew akromegalija konsistenti mal-effetti magħrufa ta' ormon tat-tkabbir żejjed.
English: Because these reactions are reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency.
Maltese: Peress li dawn ir-reazzjonijiet huma rrappurtati b'mod volontarju minn popolazzjoni ta' daqs mhux ċert, mhux possibbli li ssir stima affidabbli tal-frekwenza tagħhom.
English: smoking.
Maltese: DRESS.
English: INFORMATION IN BRAILLE OSSEOR 2 g
Maltese: INFORMAZZJONI BIL-BRAILLE OSSEOR 2 g
English: System Organ Class (SOC) Frequency category
Maltese: Sistema tal-Klassifika tal-Organi (SOC) Kategorija tal-Frekwenza Reazzjonijiet avversi
English: Relative Risk Reduction vs. placebo (95%CI), p value
Maltese: OSSEOR It-tnaqqis fir-Riskju Relattiv vs. plaċebo (95%CI), valur p
English: Italia I.F.B.
Maltese: I.F.B.
English: Suomi/Finland Servier Finland Oy
Maltese: Suomi/Finland Servier Finland Oy Puh/Tel:
English: Paper/polyethylene/aluminium/polyethylene sachets.
Maltese: Qartas tal-karti/polyethylene/aluminium/polyethylene Il-qisien tal-pakkett
English: Boxes containing 7, 14, 28, 56, 84 or 100 sachets.
Maltese: Kaxex fihom 7, 14, 28, 56, 84, jew 100 qartas.
English: Date of latest renewal: 21/09/2009
Maltese: Data tal-aħħar tiġdid: 21/09/2009
English: Strontium ranelate does not inhibit cytochrome P450 enzymes.
Maltese: Strontium ranelate ma jimpedixxix l-enżimi cytochrome P450.
English: As a divalent cation, strontium is not metabolised.
Maltese: Bħala ketajin divalenti, strontium ma jiġix metabolizzat.
English: - The other ingredients are aspartame (E 951), maltodextrin, mannitol (E 421).
Maltese: - Is-sustanzi l-oħra huma aspartame (E951), maltodextrin, mannitol (E 421).
English: EU/1/04/287/001 EU/1/04/287/002 EU/1/04/287/003 EU/1/04/287/004 EU/1/04/287/005 EU/1/04/287/006
Maltese: EU/1/04/287/001 EU/1/04/287/002 EU/1/04/287/003 EU/1/04/287/004
English: OSSEOR contains aspartame:
Maltese: OSSEOR fih aspartame
English: o Patients at risk of VTE.
Maltese: o Pazjenti f'riskju ta' VTE.
English: Placebo (n=3317)
Maltese: (n = 3317)
English: Cardiac ischaemic events
Maltese: Episodji iskemiċi kardijaċi
English: MARKETING AUTHORISATION HOLDER LES LABORATOIRES SERVIER 50, rue Carnot
Maltese: LES LABORATOIRES SERVIER 50, rue Carnot
English: Its plasma clearance is about 12 ml/min (CV 22%) and its renal clearance about 7 ml/min (CV 28%).
Maltese: L-eliminazzjoni mill-plażma huwa ta' bejn wieħed u ieħor 12 ml/min (CV 22%) u l-eliminazzjoni tal-kliewi huwa ta' bejn wieħed u ieħor 7 ml/min (CV 28%).
English: 84 sachets
Maltese: 84 qartas
English: Discontinuation of therapy was mainly due to nausea (1.3% and 2.2% in the placebo and strontium ranelate groups respectively).
Maltese: (1.3% u 2.2% fil-gruppi plaċebo u strontium ranelate rispettivament).
English: OSSEOR 2 g granules for oral suspension Strontium ranelate
Maltese: OSSEOR 2 g granijiet għal sospensjoni orali strontium ranelate
English: Interaction with laboratory test
Maltese: Interazzjoni ma' test tal-laboratorju
English: Strontium has a volume of distribution of about 1 l/kg.
Maltese: Strontium għandu volum ta' distribuzzjoni ta' bejn wieħed u ieħor 1 l/kg.
English: Percentage of Patients Experiencing the adverse reaction Treatment Strontium ranelate (n=3352)
Maltese: Perċentwal tal-pazjenti li kellhom reazzjonijiet avversi Kura Strontium ranelate (n=3352)
English: All patients received daily supplemental calcium (1000 mg) and vitamin D (800 UI).
Maltese: Il-pazjenti kollha ngħataw kalċju supplimentali ta' kuljum (1000 mg) u vitamina D (800
English: What OSSEOR contains - The active substance is strontium ranelate.
Maltese: X'fih OSSEOR - Is-sustanza attiva hi strontium ranelate.
English: LIST OF EXCIPIENTS Also contains aspartame (E 951).
Maltese: Fih ukoll aspartame (E 951).
English: 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.
Maltese: Fuq 12-il xahar, ġiet osservata żieda statistikament sinifikanti fil-BMD lumbari medju, il-kriterji medji tal-effikaċja (E (SE) = 5.32% (0.75); 95%CI = [3.86 ; 6.79]; p<0.001), simili għal dik osservata fl-istudji ta' fażi
English: Τηλ: +357 22741741
Maltese: Χ.Α.Παπαέλληνας & Σία Λτδ Τηλ: +357 22741741
English: 100 sachets
Maltese: 100 qartas
English: The absolute bioavailability of strontium is about 25% (range 19-27%) after an oral dose of 2 g strontium ranelate.
Maltese: Il-bijodisponibiltà assoluta ta' strontium hija ta' madwar 25% (bejn 19% u 27%) wara doża mill-ħalq ta' 2 g strontium ranelate.
English: N=1823
Maltese: N = 1823 N = 1817
English: OSSEOR has been studied in clinical trials involving nearly 8,000 participants.
Maltese: OSSEOR ġie studjat fi studji kliniċi li kien fihom kważi 8,000 parteċipant.
English: SOTI involved 1,649 postmenopausal women with established osteoporosis (low lumbar BMD and prevalent vertebral fracture) and a mean age of 70 years.
Maltese: SOTI involva 1,649 mara ta' wara l menopawsa b'osteoporożi stabbilit (BMD fil-lumbari baxx u prevelanza fi ksur tas-sinsla) u b'età medja ta' 70 sena.
English: In phase III studies, 85% of the patients had a creatinine clearance between 30 and 70 ml/min and 6% below 30 ml/min at inclusion, and the mean creatinine clearance was about 50 ml/min.
Maltese: III, 85% tal pazjenti kellhom eliminazzjoni tal-kreatinina ta' bejn 30 u 70 ml/min u 6% b'inqas minn 30 ml/min fil-bidu tal-istudju u l-eliminazzjoni medja tal-kreatinina kienet ta' bejn wieħed u ieħor 50 ml/min.
English: MM/YYYY
Maltese: Ġimgħa
English: Uncommon: Seizures.
Maltese: Komuni: Dermatite
English: Rare: Severe hypersensitivity reactions (DRESS: see section 2)
Maltese: Reazzjonijiet severi ta' sensittività eċċessiva (DRESS: ara sezzjoni 2) Rari ħafna:
English: Granules for oral suspension.
Maltese: U KONTENUT Granijiet għal sospensjoni orali.
English: Κύπρος Χ.Α.Παπαέλληνας & Σία Λτδ
Maltese: TAGĦRIF LI GĦANDU JIDHER FUQ IL-PAKKETT TA' BARRA
English: 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]).
Maltese: Fi studji miġburin ta' pazjenti osteoporotiċi ta' wara l-menopawsa randomizzati u kkontrollati bi plaċebo, ġiet osservata żieda sinifikanti ta' infart mijokarijaku f'pazjenti kkurati bi OSSEOR meta mqabbel ma' plaċebo (1.7% meta mqabbel 1.1%), b'riskju relattiv ta' 1.6 (95% CI = [1.07 ; 2.38]).
English: OSSEOR 2 g granules for oral suspension
Maltese: OSSEOR 2 g granijiet għal sospensjoni orali
English: Mean age was 75 years at inclusion and 23% of the patients enrolled were 80 to 100 years of age.
Maltese: L-età medja meta ddaħħlu fl-istudju kienet ta' 75 sena u 23% tal-pazjenti kellhom età li tvarja bejn it-80 u l-100 sena.
English: 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)
Maltese: Fi studji kkontrollati bi plaċebo miġburin ta' pazjenti osteoporotiċi ta' wara l-menopawsa, pazjenti kkurati bi strontium ranelate (N=3803, 11270 pazjent snin ta' kura) meta mqabbel ma' plaċebo (N=3769, 11250 pazjent snin ta' kura)
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: Current or previous venous thromboembolic events (VTE), including deep vein thrombosis and pulmonary embolism.
Maltese: Avvenimenti tromboemboliċi fil-vini (VTE) attwali jew preċedenti, inklużi trombożi profonda tal-vini u emboliżmu pulmonari.
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 l aċċettabilità tal-prodott mediċinali.
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: għandu jingħata qabel ir-raqda ta' billejl, preferibbilment mill-inqas sagħtejn wara l-ikel (ara sezzjonijiet 4.5 u 5.2).
English: EU/1/04/287/005/ 84 sachets (3 packs of 28) EU/1/04/287/006 100 sachets
Maltese: EU/1/04/287/004 56 qartas EU/1/04/287/005 84 qartas EU/1/04/287/006 100 qartas
English: The effective half-life of strontium is about 60 hours.
Maltese: bejn wieħed u ieħor 60 siegħa.
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-inċindenza annwali ta' tromboemboliżmu tal-vini (VTE) osservata għal iktar minn 5 snin kienet madwar 0.7% b'riskju relattiv ta' 1.4 (95% CI=[1.0-2.0]) f'pazjenti kkurati bi strontium ranelate meta mqabbla mal-plaċebo (ara sezzjoni 4.4).
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 l ebda avveniment klinikament relevanti.