FrancophonIA/ELRC3.0 huggingface dataset:
English: This study included postmenopausal women (N=277), premenopausal women (N=67), and men (N=83).
Maltese: Dan l-istudju kien jinkludi nisa wara l-menopawża (N=277), nisa qabel il-menopawża (N=67), u irġiel (N=83).
English: MARKETING AUTHORISATION HOLDER Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, The Netherlands
Maltese: Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, L-Olanda.
English: Becton, Dickinson and Company pen needles can be used.
Maltese: Jistgħu jintużaw labar tal-pinna ta' Becton, Dickinson and Company.
English: One pre-filled pen of 2.4 mL contains 600 micrograms of teriparatide (corresponding to 250 micrograms per mL).
Maltese: Pinna mimlija lesta ta' 2.4 mL fiha 600 mikrogramma ta' teriparatide (li tikkorrispondi għal
English: Manufactured by Lilly France, F-67640 Fegersheim, France for Eli Lilly and Company.
Maltese: Fegersheim, Franza għal Eli Lilly and Company.
English: Red Stripe Blue Body Medicine Cartridge White Cap Paper Tab Needle
Maltese: Faxx Aħmar Korp Blu Skartoċċ tal-Mediċina Kappa Bajda Siġill protettiv Labra
English: The cumulative incidence of pooled clinical fractures (clinical vertebral and non vertebral fractures) was 4.8% in Forsteo and 9.8% in risedronate-treated patients, hazard ratio (95% CI) = 0.48 (0.32-0.74), P=0.0009.
Maltese: L-inċidenza kumulattiva tal-ksur kliniku miġbur flimkien (ksur kliniku tal-vertebra u mhux tal-vertebrae) kienet 4.8% fil-pazjenti ttrattati b'Forsteo u 9.8% fil-pazjenti ttrattati b'risedronate, proporzjon ta' periklu (95% CI) = 0.48 (0.32-0.74), P=0.0009.
English: • The FORSTEO contains 28 days of medicine.
Maltese: • Il-FORSTEO fiha mediċina għal 28 ġurnata.
English: The skeletal effects of FORSTEO depend upon the pattern of systemic exposure.
Maltese: L-effetti skeletriċi ta' FORSTEO jiddependu fuq il-mod ta' espożizzjoni sistemika.
English: Pharmaco-therapeutic group: Calcium homeostasis, parathyroid hormones and analogues, ATC code: H05 AA02.
Maltese: Omeostasi tal-kalċju, ormoni tal-paratirojde u analogi, Kodiċi ATC:
English: Hydrochloric acid solution and/or sodium hydroxide solution (for pH adjustment).
Maltese: Soluzzjoni ta' hydrochloric acid u/jew soluzzjoni ta' sodium hydroxide (għall-aġġustament tal-pH).
English: Common: Depression
Maltese: Komuni: Dipressjoni
English: FORSTEO is indicated in adults.
Maltese: FORSTEO huwa indikat fl-adulti
English: 4.6 Fertility, pregnancy and lactation
Maltese: .6 Fertiltà, tqala u treddigħ
English: Pregnancy FORSTEO is contraindicated for use during pregnancy (see section 4.3).
Maltese: Tqala Waqt it-tqala l-użu ta' FORSTEO huwa kontra-indikat (ara sezzjoni 4.3).
English: Hydrochloric acid (for pH adjustment) Sodium hydroxide (for pH adjustment) Water for injections
Maltese: Hydrochloric acid (għall-aġġustament tal-pH) Sodium hydroxide(għall-aġġustament tal-pH)
English: 437 patients (mean age 58.7 years) were enrolled in a clinical trial for men with hypogonadal (defined as low morning free testosterone or an elevated FSH or LH) or idiopathic osteoporosis.
Maltese: 437 pazjent (età medja 58.7 snin) ġew irreġistrati fi studju kliniku għall-irġiel b'osteoporożi tat-tip ipogonadali (definita bħala livell baxx tat-testosterone ħieles fid-demm ta' filgħodu jew livell għoli ta' FSH jew LH) jew idjopatika.
English: Each dose of 80 microliters contains 20 micrograms of teriparatide*.
Maltese: Kull doża ta' 80 mikrolitri fiha 20 mikrogramma ta' teriparatide*.
English: Studies in rabbits have shown reproductive toxicity (see section 5.3).
Maltese: Fertilità Studji fil-fniek urew tossiċità fis-sistema riproduttiva (ara sezzjoni 5.3).
English: Yellow Shaft
Maltese: TAGĦRIF
English: Typically, an event began within 4 hours of dosing and spontaneously resolved within a few minutes to a few hours.
Maltese: Tipikament, każ beda' 4 sigħat minn meta ngħatat id-doża u waqaf waħdu fi żmien ta' bejn ftit minuti u ftit sigħat.
English: At 24 months, the mean increase from baseline in lumbar spine, total hip and femoral neck BMD was 10.5 %, 2.6 % and 3.9 % respectively.
Maltese: Fl-24 xahar, iż-żieda medja fil-BMD tas-sinsla lumbari, tat-total tal-ġenbejn u tal-għonq femorali mil-linja bażi kien rispettivament 10.5 %, 2.6 % u 3.9 %.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/03/247/001
Maltese: EU/1/03/247/001 EU/1/03/247/002
English: Overdose experience based on post-marketing spontaneous reports In post-marketing spontaneous reports, there have been cases of medication error where the entire contents (up to 800 mcg) of the teriparatide pen have been administered as a single dose.
Maltese: F'rapporti spontanji wara t-tqegħid fis-suq, kien hemm każijiet ta' żbalji fil-medikazzjoni fejn il kontenut kollu (sa 800 mkg) tal-pinna ta' teriparatide ngħata f'doża waħda.
English: Τηλ: + 357 22 715000
Maltese: Phadisco Ltd Τηλ: + 357 22 715000
English: At 36 months, analysis of spinal X-rays from 169 alendronate patients and 173 FORSTEO patients showed that 13 patients in the alendronate group (7.7 %) had experienced a new vertebral fracture compared with 3 patients in the FORSTEO group (1.7 %) (p=0.01).
Maltese: Wara 36 xahar, analiżi tal-X-rays tas-sinsla minn 169 pazjent fuq alendronate u minn 173 pazjent fuq FORSTEO wrew li 13-il pazjent fil-grupp ta' alendronate (7.7 %) kellhom ksur wieħed vertebrali ġdid meta mqabbel ma' 3 pazjenti fil-grupp ta' FORSTEO (1.7 %) (p=0.01).
English: • if you suffer from kidney problems (moderate renal impairment).
Maltese: • jekk tbati minn xi problemi tal-kliewi (indeboliment moderat tal-kliewi).
English: Uncommon: may affect up to 1 in 100 people
Maltese: Mhux komuni: jistgħu jolqtu sa persuna 1 minn kull 100
English: All patients were offered 1000 mg calcium per day and at least 400 IU vitamin D per day.
Maltese: Il-pazjenti kollha ġew mogħtija 1000 mg calcium kuljum u mhux inqas minn 400 IU vitamina D kuljum.
English: FORSTEO is eliminated through hepatic and extra-hepatic clearance (approximately 62 L/hr in women and 94 L/hr in men).
Maltese: FORSTEO jiġi eliminat permezz ta' tneħħija mill-fwied u barra mill-fwied (madwar 62 l/hr fin-nisa u 94 l/hr fl-irġiel).
English: Store in a refrigerator (2°C - 8°C) at all times.
Maltese: Aħżen fi friġġ (2°C - 8°C) f' kull ħin.
English: There was no evidence of hypersensitivity reactions, allergic reactions, effects on serum calcium, or effects on Bone Mineral Density (BMD) response.
Maltese: Ma kienx hemm evidenza ta' reazzjonijiet ta' sensittivita' eċċessiva, reazzjonijiet allerġiċi, effetti fuq calcium fis-serum, jew effetti fuq id-Densità Minerali tal-Għadam
English: Uncommon: Injection site erythema, injection site reaction Rare: Possible allergic events soon after injection: acute dyspnoea, oro/facial oedema, generalised urticaria, chest pain, oedema (mainly peripheral).
Maltese: Il-possibiltà ta' avvenimenti allerġiċi ftit wara l-injezzjoni: qtugħ ta' nifs akut, edima orali/tal-wiċċ, urtikarja ġeneralizzata, uġigħ fis-sider, edima (l-iżjed periferali).
English: Common: may affect up to 1 in 10 people
Maltese: Komuni: jistgħu jolqtu sa persuna 1 minn kull 10
English: Eli Lilly ČR, s.r.o.
Maltese: ČR, s.r.o.
English: - The other ingredients are glacial acetic acid, sodium acetate (anhydrous), mannitol, metacresol, and water for injections.
Maltese: - L-ingredjenti l-oħrajn huma: glacial acetic acid, sodium acetate (anidrat), mannitol, metacresol,
English: Once opened, the product may be stored for a maximum of 28 days at 2°C to 8°C.
Maltese: Ladarba nfetaħ, il-prodott jista' jinħażen għal massimu ta' 28 jum f' temperatura ta' bejn 2°C u 8°C.
English: Endogenous 84-amino-acid parathyroid hormone (PTH) is the primary regulator of calcium and phosphate metabolism in bone and kidney.
Maltese: Mekkaniżmu ta' azzjoni L-ormon endoġenu 84-amino-acid tal-paratirojde (PTH) huwa r-regulatur prinċipali tal-metaboliżmu ta' calcium u phosphate fl-għadam u fil-kliewi. FORSTEO (rhPTH(1-34)) hija l-parti attiva (1-34) ta'
English: Transient, orthostatic hypotension or dizziness was observed in some patients.
Maltese: Ipotensjoni ortostatika tranżitorja jew sturdament ġew osservati f'xi pazienti.
English: This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially “sodiumfree”.
Maltese: Din il-mediċina fiha inqas minn mmol 1 ta' sodium (23 mg) għal kull doża, jiġifieri tista' tgħid li huwa “ħieles mis-sodium”.
English: Baseline spinal and femoral neck bone mineral density mean T-scores were -2.2 and -2.1, respectively.
Maltese: Bħala linja bażi, il-medja tat-T-scores tad-densità minerali ta' l-għadam tas-sinsla u ta' l-għonq tal-femorali kienu ta' -2.2 u ta' -2.1 rispettivament.
English: FORSTEO increased BMD at the total hip (3.6 %) compared with alendronate (2.2 %) (p<0.01), as well as at the femoral neck (3.7 %) compared with alendronate (2.1 %) (p<0.05).
Maltese: alendronate (2.2 %) (p<0.01) kif ukoll fl-għonq ta' l-għadma tal-koxxa (3.7 %) meta mqabbel ma' alendronate (2.1 %) (p<0.05).
English: The device can be used with insulin pen injection needles.
Maltese: Dejjem aħsel idejk qabel kull injezzjoni.
English: 3 pens of 2.4 mL solution each.
Maltese: Pinna ta' soluzzjoni ta' 2.4 mL . 3 pinen ta' soluzzjoni ta' 2.4 ml kull wieħed.
English: Eli Lilly Holdings Limited, pārstāvniecība Latvijā
Maltese: Eli Lilly Holdings Limited Eesti filiaal Tel:
English: Each pen contains 2.4 mL of solution enough for 28 doses.
Maltese: Kull pinna fiha 2.4 mL ta' soluzzjoni li huma biżżejjed għal 28 doża.
English: At baseline, the women had a mean age of 72.1 years and a median of 2 prevalent vertebral fractures; 57.9% of patients had received previous bisphosphonate therapy and 18.8% took concomitant glucocorticoids during the study.
Maltese: Fil-linja bażi, n-nisa kellhom età medja ta' 72.1 sena u medjan ta' 2 ksur prevalenti tal-vertebrae; 57.9% tal-pazjenti kienu rċivew terapija preċedenti b'bisphosphonate u 18.8% ħadu glukokortikojdi fl-istess waqt matul l-istudju. 1,013-il pazjenta (74.5%) temmew l-24 xahar ta' segwitu.
English: BMD T score of −2.7, median prednisone equivalent dose of 7.5 mg/day, and 34 % had one or more radiographic vertebral fractures; premenopausal women had a mean age of 37 years, mean lumbar spine BMD T score of −2.5, median prednisone equivalent dose of 10 mg/day, and 9 % had one or more radiographic vertebral fractures; and men had a mean age of 57 years, mean lumbar spine BMD
Maltese: 34 %, skond ir-radjografiji, kellhom ksur ta' wieħed jew ta' aktar vertebra; in-nisa qabel il-menopawża kellhom età medja ta' 37 sena, medja ta' BMD fil-parti lumbari ta' l-ispina b'valur T ta' -2.5, doża medja ekwivalenti għal 10 mg/jum ta' prednisone u 9 %, skond ir-radjografiji, kellhom ksur ta'
English: m.b.H.
Maltese: (BMD).
English: In premenopausal women, the increase in BMD from baseline to 18 month endpoint was significantly greater in the FORSTEO group compared with the alendronate group at the lumbar spine (4.2 % versus −1.9 %; p<0.001) and total hip (3.8 % versus 0.9 %; p=0.005).
Maltese: Fin-nisa qabel il-menopawża, iż-żieda fil-BMD mil-linja bażi sar-riżultat finali wara 18-il xahar kien iżjed, b'mod sinifikanti, fil-grupp ta' FORSTEO meta mqabbel mal-grupp ta' alendronate fil-parti lumbari ta' l-ispina (4.2 % kontra -1.9 %; p<0.001) u mal-ġenbejn kollu (3.8 % kontra 0.9 %;
English: Uncommon: Tachycardia
Maltese: Mhun komuni: Takikardija Disturbi vaskulari
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each mL contains 250 micrograms of teriparatide.
Maltese: Kull mL fih 250 mikrogramma ta' teriparatide
English: Postmenopausal osteoporosis
Maltese: Osteoporożi wara l-menopawża
English: Of patients in the teriparatide trials, 82.8 % of the FORSTEO patients and 84.5 % of the placebo patients reported at least 1 adverse event.
Maltese: F' pazjenti fil-provi b'teriparatide, 82.8% tal-pazjenti li ħadu FORSTEO u 84.
English: • Write down your first injection date on a calendar.
Maltese: • Ikteb id-data ta' l-ewwel injezzjoni tiegħek fil-kalendarju.
English: Lumbar spine BMD significantly increased by 3 months.
Maltese: BMD tas-sinsla lumbari żdied b' mod sinjifikanti wara 3 xhur.
English: No differences in FORSTEO pharmacokinetics were detected with regard to age (range 31 to 85 years).
Maltese: Anzjani L-ebda differenza ma dehret fil-farmakokinetiċita' ta' FORSTEO rigward l-eta' (medda 31 sa 85 sena).
English: Skin and subcutaneous tissue disorders
Maltese: Disturbi muskolu-skeltrali u tat-tessuti konnettivi
English: In clinical trials, 2.8 % of FORSTEO patients had serum uric acid concentrations above the upper limit of normal compared with 0.7 % of placebo patients.
Maltese: Fil-provi kliniċi, 2.8% tal-pazjenti li ħadu FORSTEO kellhom konċentrazzjonijiet ta' uric acid fis-serum ogħla mill-limitu ta' fuq tannormal meta mqabbel ma' 0.7% ta' pazjenti li ġew ikkurati bil-plaċebo.
English: In addition, 15 of 214 patients in the alendronate group (7.0 %) had experienced a non-vertebral fracture compared with 16 of 214 patients in the FORSTEO group (7.5 %) (p=0.84).
Maltese: 214-il pazjent fil-grupp ta' FORSTEO (7.5 %) (p=0.84).
English: Eli Lilly Holdings Limited Eesti filiaal Tel: + 372 6817 280
Maltese: Eli Lilly Holdings Limited pārstāvniecība Latvijā Tel: + 371 67364000
English: Patients with renal impairment
Maltese: Insuffiċjenza/indeboliment renali
English: Pharmacodynamic effects
Maltese: Effett farmakodinamiku
English: Solution
Maltese: LISTA
English: Serum calcium concentrations reach a maximum between 4 and 6 hours and return to baseline by 16 to 24 hours after each dose of teriparatide.
Maltese: Il-konċentrazzjonijiet ta' calcium fis-serum jilħqu massimu bejn 4 u 6 sigħat u jirritornaw lura bħal qabel bejn 16 u 24 siegħa wara kull doża ta'
English: Urolithiasis
Maltese: Urolitjażi
English: Inject dose
Maltese: Buttuna tal
English: The mean (median) cumulative dose of glucocorticoid was 474.3 (66.2) mg in the teriparatide arm and 898.0 (100.0) mg in the risedronate arm.
Maltese: Il-medja (medjan) tad-doża kumulattiva talglukokortikojd kienet 474.3 (66.2) mg fil-fergħa ta' teriparatide u 898.0
English: Premenopausal women with glucocorticoid-induced osteoporosis should be considered at high risk for fracture if they have a prevalent fracture or a combination of risk factors that place them at high risk for fracture (e.g., low bone density [e.g., T score ≤−2], sustained high dose glucocorticoid therapy [e.g., ≥7.5 mg/day for at least 6 months], high underlying disease activity, low sex steroid levels).
Maltese: Nisa qabel il-menopawża b'osteoporożi kkawżata minħabba t-teħid ta' glukokortikojdi għandhom jiġu kkunsidrati li għandhom riskju għoli ta' ksur jekk diġà għandhom xi ksur jew għandhom taħlita ta' fatturi ta' riskju li jpoġġuhom f'riskju għoli li jkollhom xi ksur (eżempju densità ta' l-għadam baxx [ eżempju valur T ≤ 2], terapija fit-tul ta' glukokortikojdi b'dożi għoljin [ eżempju.> 7.5 mg/jum għallinqas għal 6 xhur], il-marda stess ta' l-osteoporożi hija attiva ħafna, il-livelli ta' l-isterojdi tas sess huma baxxi).
English: Non-vertebral fragility fractures c
Maltese: Ksur ta' fraġilità mhux vertebrali c
English: Eli Lilly Sweden AB Tel: + 46 (0) 8 7378800
Maltese: Tel: + 46-(0) 8 7378800
English: Set dose
Maltese: FORSTEO tiegħi
English: To prevent one or more new vertebral fractures, 11 women had to be treated for a median of 19 months.
Maltese: Biex jiġi evitat ksur waħdani jew aktar vertebrali ġdid, 11-il mara kellhom jiġu kkurati għal medja ta' 19-il xahar.
English: Independent risk factors, for example, low BMD, age, the existence of previous fracture, family history of hip fractures, high bone turnover and low body mass index should be considered in order to identify women and men at increased risk of osteoporotic fractures who could benefit from treatment.
Maltese: Għandhom jiġu kkunsidrati l-fatturi ta' riskju indipendenti bħal per eżempju-BMD baxx, l-età, lesiżtenza ta' ksur preċedenti, passat mediku fil-familja ta' ksur fl-għadam tal-ġenbejn, rata għolja fittibdil ta' l-għadam u indiċi tal-massa tal-ġisem baxx sabiex jiġu identifikati dawk in-nisa u irġiel li għandhom riskju ogħla ta' ksur osteoporotiku u li jistgħu jibbenefikaw mill-kura.
English: FORSTEO contains sodium:
Maltese: FORSTEO fih is-sodium
English: Common: Nausea, vomiting, hiatus hernia, gastroesophageal reflux disease Uncommon: Haemorrhoids
Maltese: Komuni: Sturdament, uġigħ ta' ras, xjatika, sinkope Disturbi fil-widnejn u fis-sistema labirintika Komuni: Vertigo
English: After 12 months, BMD had increased in the lumbar spine and total hip by 5 % and 1 %, respectively, compared with placebo.
Maltese: Wara 12-il xahar, BMD kien żdied fil-għadma tal-ġenbejn b' 5% u 1% rispettivament meta mqabbel ma' plaċebo.
English: FORSTEO is used to treat osteoporosis in adults.
Maltese: FORSTEO jintuża għall-kura ta' l-osteoporożi fl-adulti.
English: • chest pain
Maltese: • ħass ħażin
English: Uncommon: Urinary incontinence, polyuria, micturition urgency, nephrolithiasis Rare: Renal failure/impairment
Maltese: Mhux komuni: Inkontinenza urinarja, tgħaddi ammont eċċessiv ta' awrina, urġenza biex tgħaddi lawrina, nefrolitjażi
English: Date of first use:
Maltese: Data ta' l-ewwel użu:
English: After 19 months (median) treatment, bone mineral density (BMD) had increased in the lumbar spine and total hip, respectively, by 9 % and 4 % compared with placebo (p<0.001).
Maltese: Wara 19-il xahar (medja) ta' kura, id-densità minerali ta' l-għadam (BMD) kienet żdiedet fis-sinsla lumbari u fl-għadma tal-ġenbejn, b' 9 % u 4 % rispettivament meta mqabbla mal-plaċebo (p<0.
English: At the 18 month endpoint, FORSTEO significantly increased lumbar spine BMD (7.2 %) compared with alendronate (3.4 %) (p<0.001).
Maltese: Matul medja ta' 18-il xahar wara l-waqfien tal-kura b' FORSTEO, kien hemm 41% tnaqqis (p=0.004)
English: Other medicines and FORSTEO
Maltese: Mediċini oħra u FORSTEO
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION FORSTEO 20 micrograms/80 microliters, injection Teriparatide
Maltese: FORSTEO 20 mikrogramma/80 mikrolitri, injezzjoni Teriparatide
English: Glucocorticoid-induced osteoporosis
Maltese: Kalċju fis-serum u fl-awrina
English: Experience in the younger adult population, including premenopausal women, is limited (see section 5.1).
Maltese: Popolazzjoni ta' adulti mhux daqshekk kbar Hija limitata l-esperjenza fil-popolazzjoni ta' adulti mhux daqshekk kbar li tinkludi n-nisa qabel il menopawża (ara sezzjoni 5.1).
English: • feeling faint
Maltese: FEJN MA
English: The mean increase in BMD from 18 to 24 months was 1.4 %, 1.2 %, and 1.6 % at the lumbar spine, total hip and femoral neck, respectively.
Maltese: Iż-żieda medja mit-18 sa 24 xahar fil-BMD tal-parti lumbari tas-sinsla, tat-total tal-ġenbejn u tal-għonq femorali kien rispettivament 1.4 %, 1.2 % u 1.6 %
English: Package leaflet: Information for the user FORSTEO 20 micrograms/80 microliters solution for injection in pre-filled pen Teriparatide
Maltese: Informazzjoni għall-utent FORSTEO 20 microgramma/80 mikrolitri soluzzjoni għall-injezzjoni ġo pinna mimlija lesta
English: • increase in an enzyme called alkaline phosphatase.
Maltese: • Tittrasferixxix il-mediċina għal ġo siringa.
English: What FORSTEO contains - The active substance is teriparatide.
Maltese: - Is-sustanza attiva hija teriparatide.
English: Uncommon: Myalgia, arthralgia, back cramp/pain* Renal and urinary disorders
Maltese: Komuni: Tqalligħ, rimettar, ħiatus hernia, mard ta' rifluss gastro-esofagali
English: Results from up to 24 months (median: 19 months) treatment with FORSTEO demonstrate statistically significant fracture reduction (Table 1).
Maltese: Ir-riżultati sa 24-il xahar (medja: 19-il xahar) kura b' FORSTEO wrew tnaqqis ta' ksur statistikament sinjifikanti (Tabella 1).
English: • haemorrhoids (piles)
Maltese: • żieda fil-piż
English: Once-daily administration of FORSTEO increases apposition of new bone on trabecular and cortical bone surfaces by preferential stimulation of osteoblastic activity over osteoclastic activity.
Maltese: stimolu preferenzjali ta' attivita' osteoblastika fuq attivita' osteoklastika.
English: Physiological actions of PTH include stimulation of bone formation by direct effects on bone forming cells (osteoblasts) indirectly increasing the intestinal absorption of calcium and increasing the tubular re-absorption of calcium and excretion of phosphate by the kidney.
Maltese: L-azzjonijiet fiżjoloġiċi ta' PTH jikludu stimolu talformazzjoni ta' l-għadam permezz ta' effetti diretti fuq iċ-ċelloli li jiffurmaw l-għadam (osteoblasts) li jżidu indirettament l-assorbiment mill-intestin ta' calcium u li jżidu l-assorbiment mill-ġdid tubulari ta' calcium u l-eskrezzjoni ta' phosphate mill-kliewi.
English: Common: Muscle cramps
Maltese: Mhux komuni: Murliti
English: Each millilitre of the solution for injection contains 250 micrograms of teriparatide.
Maltese: Kull millilitru ta' soluzzjoni għall-injezzjoni fih 250
English: • muscle cramps
Maltese: • emorrojdi (murliti)
English: FORSTEO may cause small increases in urinary calcium excretion, but the incidence of hypercalciuria did not differ from that in the placebo-treated patients in clinical trials.
Maltese: ipercalciuria ma kinitx differenti minn dik fil-pazjenti kkurati bil-plaċebo f' provi kliniċi.
English: General disorders and administration site conditions Common: Fatigue, chest pain, asthenia, mild and transient injection site events, including pain, swelling, erythema, localised bruising, pruritis and minor bleeding at injection site.
Maltese: Komuni: Għeja, uġigħ fis-sider, astenja, avvenimenti ħfief u momentanji fis-sit ta' l-injezzjoni, li jinkludu wġigħ , nefħa, eritema, tbenġil lokalizzat, ħakk u xi ftit ta' fsada fis-sit ta' l-injezzjoni.
English: • low haemoglobin or red blood cell count (anaemia)
Maltese: • ammont baxx ta' emoglobina jew taċ-ċelluli ħomor fid-demm (anemija)
English: Hold it in and count to 5 s-l-o-w-l-y. Then pull the needle from skin.
Maltese: Segwi l-istruzzjonijiet bir-reqqa meta tuża l-pinna.
English: • Check the FORSTEO label to make sure you have the correct medicine.
Maltese: • Iċċekkja t-tiketta tal-FORSTEO biex tkun ċert li għandek il-mediċina korretta u li ma skadietx.
English: FORSTEO, 20 microgram (µg) 80 microlitres solution for injection, in pre-filled pen
Maltese: FORSTEO, 20 mikrogramma (µg) soluzzjoni għallinjezzjoni ta' 80 mikrolitru, f'pinna mimlija għal-lest
English: Eli Lilly Italia S.p.A. Tel: + 39 055 42571
Maltese: Tel: + 39- 055 42571
English: Co-administration of raloxifene or hormone replacement therapy with FORSTEO did not alter the effects of FORSTEO on serum or urine calcium or on clinical adverse events.
Maltese: L-għotja ta' raloxifene jew terapija ta' sostituzzjoni ta' l-ormoni flimkien ma' FORSTEO ma biddlitx l-effetti ta' FORSTEO fuq calcium fis-serum jew fl-awrina jew fuq episodji avversi kliniċi.
English: Treatment of osteoporosis associated with sustained systemic glucocorticoid therapy in women and men at increased risk for fracture (see section 5.1).
Maltese: Kura ta' osteoporożi assoċjata ma' terapija b'glukokortikojdi sistemiċi meħuda fit-tul, fin-nisa u fl irġiel li qegħdin f'riskju ogħla ta' ksur (ara sezzjoni 5.1).
English: Storing Your FORSTEO
Maltese: nissettja l-FORSTEO
English: FORSTEO is a bone formation agent to treat osteoporosis.
Maltese: FORSTEO huwa soluzzjoni bla kulur u ċara.
English: FORSTEO 20 micrograms (µg)/ 80 microlitres solution for injection, in pre-filled pen Instructions for use
Maltese: FORSTEO 20 mikrogramma (µg)/ 80 mikrolitru soluzzjoni għall-injezzjoni ta', f'pinna mimlija għal-lest
English: The efficacy of FORSTEO in men and women (N=428) receiving sustained systemic glucocorticoid therapy (equivalent to 5 mg or greater of prednisone for at least 3 months) was demonstrated in the 18month primary phase of a 36 month, randomised, double-blind, comparator-controlled study (alendronate 10 mg/day).
Maltese: Osteoporożi kkawżata minħabba t-teħid ta' glukokortikojdi L-effikaċja ta' Forsteo f'irġiel u nisa (N=428) li kienu qed jirċievu terapija bil-glukokotikojdi b'mod sistemiku fit-tul (ekwivalenti għal 5 mg jew iżjed ta' prednisone meħuda għallinqas għal 3 xhur) ġiet murija fl-ewwel fażi ta' 18-il xahar ta' studju double-blind, randomised, ikkontrollat b'komparatur
English: No clinically significant interactions were noted.
Maltese: Ma ġew innutati l-ebda interazzjonijiet klinikament sinjifikanti.