FrancophonIA/ELRC3.0 huggingface dataset:
English: At the end of each dosing interval, CTX reductions were partially attenuated from maximal reduction of ≥ 87% to approximately ≥ 45% (range 45-80%), reflecting the reversibility of Prolia's effects on bone remodelling once serum levels diminish.
Maltese: Fl-aħħar ta' kull intervall ta' dożaġġ, tnaqqis f'CTX kien parzjalment attenwat minn tnaqqis massimu ta' ≥ 87% għal madwar ≥ 45% (firxa 45-80%), li jirrifletti r-riversibilità tal-effetti ta' Prolia fuq l-immudellar mill-ġdid talgħadam ladarba l-livelli fis-serum jonqsu.
English: Lichenoid drug eruptions
Maltese: GĦAMLA FARMAĊEWTIKA
English: Osteonecrosis of the external auditory canal2
Maltese: Osteonekrosi tal-kanal estern tassmigħ2
English: Other medicines and Prolia
Maltese: Mediċini oħra u Prolia
English: Syringe label Used syringe barrel
Maltese: Molla tas-sigurtà tallabra użata
English: Adequate intake of calcium and vitamin D is important in patients with severe renal impairment or receiving dialysis (see section 4.4).
Maltese: Teħid adegwat ta' kalċju u vitamina D huwa importanti f'pazjenti b'indeboliment sever talkliewi jew li qed jirċievu dijalisi (ara sezzjoni 4.4).
English: Do not use Prolia
Maltese: Tużax Prolia
English: 2 Excludes those of the vertebrae, skull, facial, mandible, metacarpus, and finger and toe phalanges.
Maltese: 2 Jeskludi dawk tal-vertebra, qorriegħa, wiċċ, xedaq, metakarpu, u falanġi tas-swaba' tal-idejn u tas-saqajn.
English: Skin infections leading to hospitalisation were reported in 0.1% (3 out of 4,041) of postmenopausal women with osteoporosis receiving placebo versus 0.4% (16 out of 4,050) of women receiving Prolia.
Maltese: Infezzjonijiet fil-ġilda li wasslu għal dħul fl-isptar kienu rrappurtati f'0.1% (3 minn 4,041) ta' nisa wara l-menopawsa b'osteoporożi li kienu qed jirċievu plaċebo kontra 0.4% (16 minn 4,050) ta' nisa li kienu qed jirċievu Prolia.
English: Prolia significantly increased BMD at all clinical sites measured, relative to treatment with placebo at 3 years: 7.9% at the lumbar spine, 5.7% at the total hip, 4.9% at the femoral neck, 6.9% at the hip trochanter, 6.9% at the distal 1/3 radius and 4.7% at the total body (all p < 0.0001).
Maltese: Meta mqabbel ma' trattament bil-plaċebo Prolia żied il-BMD fis-siti kliniċi mkejla kollha b'mod sinifikanti wara 3 snin: fl-ispina lombari b'7.9%, fil-ġenbejn totali b'5.7%, fl-għonq tal-wirk b'4.9%, fit-trochanter tal-ġenbejn b'6.9%, fid-distal 1/3 radius b'6.9% u fil-ġisem totali b'4.7% (kollha p < 0.0001).
English: Prolia contains denosumab, a protein (monoclonal antibody) that interferes with the action of another protein, in order to treat bone loss and osteoporosis.
Maltese: Prolia fih denosumab, proteina (antikorp monoklonali) li tfixkel l-azzjoni ta' proteina oħra biex b'hekk tittratta t-telf tal-għadam u osteoporożi.
English: The pharmacokinetic profile in paediatric populations has not been assessed.
Maltese: Il-profil farmakokinetiku f'popolazzjonijiet pedjatriċi ma ġiex evalwat.
English: • skin condition with itching, redness and/or dryness (eczema),
Maltese: • kondizzjoni fil-ġilda bil-ħakk, ħmura u/jew ġilda xotta (ekżema),
English: Efficacy and safety of Prolia once every 6 months for 3 years were investigated in men with histologically confirmed non-metastatic prostate cancer receiving ADT (1,468 men aged 48-97 years) who were at increased risk of fracture (defined as > 70 years, or < 70 years with a BMD T-score at the lumbar spine, total hip, or femoral neck < -1.0 or a history of an osteoporotic fracture.)
Maltese: L-effikaċja u s-sigurtà ta' Prolia darba kull 6 xhur għal 3 snin kienu nvestigati f'irġiel b'kanċer mhux metastatiku tal-prostata kkonfermat b'mod istoloġiku li kienu qed jirċievu ADT (1,468 raġel b'età ta' 48-97 sena) li kienu f'riskju akbar ta' ksur (definit bħala > 70 sena, jew < 70 sena b'punteġġ T ta' BMD fl-ispina lombari, ġenbejn totali, jew għonq tal-wirk ta' < -1.0 jew b'passat ta' ksur osteoporotiku.)
English: Efficacy and safety of Prolia once every 6 months for 2 years were investigated in women with non-metastatic breast cancer (252 women aged 35-84 years) and baseline BMD T-scores between -1.0 to -2.5 at the lumbar spine, total hip or femoral neck.
Maltese: L-effikaċja u s-sigurtà ta' Prolia darba kull 6 xhur għal sentejn kienu investigati f'nisa b'kanċer mhux metastatiku tas-sider (252 mara b'età ta' 35-84 sena) u b'punteġġi T ta' BMD fil-linja bażi fl-ispina lombari, ġenbejn totali jew għonq tal-wirk minn -1.0 sa -2.5.
English: In clinical trials, musculoskeletal pain was very common in both denosumab and placebo groups.
Maltese: Fi provi kliniċi, uġigħ fl-għadam kienet komuni ħafna fiż-żewġ gruppi denosumab u plaċebo.
English: There are no clinical data on the co-administration of denosumab and hormone replacement therapy (oestrogen), however the potential for a pharmacodynamic interaction is considered to be low.
Maltese: M'hemmx data klinika dwar l-għoti ta' denosumab flimkien ma' terapija ta' sostituzzjoni tal-ormon (oestrogen), madankollu l-potenzjal għal interazzjoni farmakodinamika huwa meqjus li huwa baxx.
English: If any patient presents with suspected symptoms of hypocalcaemia during treatment (see section 4.8 for symptoms) calcium levels should be measured.
Maltese: Jekk xi pazjent ikollu sintomi li jissuġġerixxu ipokalċimija waqt it-trattament (ara sezzjoni 4.8 għal sintomi) il-livelli tal-kalċju għandhom jitkejlu.
English: Finger grips Syringe label Syringe barrel
Maltese: Ż-ŻGĦAR EWLENIN TIKKETTA TAS-SIRINGA MIMLIJA GĦAL-LEST BI JEW MINGĦAJR PROTEZZJONI TAL-LABRA (FIL-FOLJA)
English: In the glucocorticoid-continuing subpopulation, Prolia demonstrated a greater increase in lumbar spine BMD compared to risedronate at 1 year (Prolia 3.6%, risedronate 2.0%; p < 0.001) and 2 years (Prolia 4.5%, risedronate 2.2%; p < 0.001).
Maltese: Effett fuq id-Densità tal-Minerali fl-Għadam (BMD) Fis-subpopolazzjoni li kompliet il-glukokortikojd, Prolia wera żieda akbar fil-BMD tal-ispina lombari meta mqabbel ma' risedronate f'sena (Prolia 3.6%, risedronate 2.0%; p < 0.001) u f'sentejn (Prolia 4.5%, risedronate 2.2%; p < 0.001).
English: Urinary tract infection Upper respiratory tract infection Diverticulitis1
Maltese: Infezzjoni fl-apparat tal-awrina Infezzjoni fl-apparat respiratorju ta' fuq Divertikulite1
English: The use of Prolia in children and adolescents has not been studied.
Maltese: L-użu ta' Prolia fi tfal u adolexxenti ma kienx studjat.
English: Denosumab has been administered in clinical studies using doses up to 180 mg every 4 weeks (cumulative doses up to 1,080 mg over 6 months), and no additional adverse reactions were observed.
Maltese: Fi studji kliniċi Denosumab ingħata bl-użu ta' dożi sa 180 mg kull 4 ġimgħat (dożi kumulattivi sa 1,080 mg fuq perjodu ta' 6 xhur), u ma kienux osservati reazzjonijiet avversi oħra.
English: These measures will help to protect the environment.
Maltese: Prolia ma kienx ittestjat f'nisa tqal.
English: In genetically engineered mice in which RANKL has been turned off by gene removal (a “knockout mouse”), studies suggest absence of RANKL (the target of denosumab see section 5.1) during pregnancy may interfere with maturation of the mammary gland leading to impaired lactation post-partum (see section 5.3).
Maltese: Fi studji fuq l-annimali, inibizzjoni ta' RANK/RANK ligand (RANKL) kienet marbuta ma' inibizzjoni tat-tkabbir tal-għadam u ma' nuqqas ta' ħruġ ta' snien (ara sezzjoni 5.3).
English: Pain in extremity Musculoskeletal pain1
Maltese: Uġigħ fl-estremitajiet Uġigħ muskoluskeletriku1
English: Concomitant treatment with other denosumab-containing medicinal products Patients being treated with Prolia should not be treated concomitantly with other denosumab-containing medicinal products (for prevention of skeletal related events in adults with bone metastases from solid tumours).
Maltese: Trattament fl-istess waqt bi prodotti mediċinali oħra li fihom denosumab Pazjenti li qed jiġu ttrattati bi Prolia m'għandhomx jiġu ttrattati fl-istess waqt bi prodotti mediċinali oħra li fihom denosumab (għall-prevenzjoni ta' avvenimenti skeletriċi relatati f'adulti b'metastasi flgħadam minn tumuri solidi).
English: The following risk factors should be considered when evaluating a patient's risk of developing ONJ:
Maltese: Il-fatturi ta' riskju li ġejjin għandhom jiġu kkunsidrati fl-evalwazzjoni tar-riskju tal-pazjent li jiżviluppa ONJ:
English: Patients must be adequately supplemented with calcium and vitamin D (see section 4.4).
Maltese: Il-pazjenti għandhom jiġu supplimentati b'mod adegwat b'kalċju u vitamina D (ara sezzjoni 4.4).
English: Absolute risk reduction (%) (95% CI)
Maltese: Tnaqqis assolut tarriskju (%) (CI ta' 95%)
English: • constipation,
Maltese: • stitikezza,
English: Lichenoid drug eruptions1
Maltese: Kull ksur kliniku1
English: The safety and efficacy of denosumab have not been studied in patients with hepatic impairment (see section 5.2).
Maltese: Is-sigurtà u l-effikaċja ta' denosumab ma kienux studjati f'pazjenti b'indeboliment tal-fwied (ara sezzjoni 5.2).
English: Prolia increased BMD by 9.2% at the lumbar spine, 6.0% at the total hip, 4.8% at the femoral neck, 7.9% at the hip trochanter, 3.5% at the distal 1/3 radius and 4.1% at the total body over 3 years (all p < 0.0001).
Maltese: Fuq perjodu ta' 3 snin Prolia żied il-BMD fl-ispina lombari b'9.2%, filġenbejn totali b'6.0%, fl-għonq tal-wirk b'4.8%, fit-trochanter tal-ġenbejn b'7.9%, fid-distal 1/3 radius b'3.5% u fil-ġisem totali b'4.1% (kollha p < 0.0001).
English: Women received calcium (at least 1,000 mg) and vitamin D (at least 400 IU) supplementation daily.
Maltese: In-nisa rċevew supplimenti kuljum ta' kalċju (tal-inqas 1,000 mg) u vitamina D (tal-inqas 400 IU).
English: Prolia significantly increased BMD at all clinical sites measured, relative to treatment with placebo at 2 years: 7.6% at lumbar spine, 4.7% at total hip, 3.6% at femoral neck, 5.9% at hip trochanter, 6.1% at distal 1/3 radius and 4.2% at total body (all p < 0.0001).
Maltese: Meta mqabbel ma' trattament bil-plaċebo Prolia żied il-BMD fis-siti kliniċi mkejla kollha b'mod sinifikanti wara sentejn: fl-ispina lombari b'7.6%, fil-ġenbejn totali b'4.7%, flgħonq tal-wirk bi 3.6%, fit-trochanter tal-ġenbejn b'5.9%, fid-distal 1/3 radius b'6.1% u fil-ġisem totali b'4.2% (kollha p < 0.0001).
English: Possible risk factors for osteonecrosis of the external auditory canal include steroid use and chemotherapy and/or local risk factors such as infection or trauma.
Maltese: Fatturi ta' riskju possibbli għal osteonekrosi tal-kanal estern tas-smigħ jinkludu l-użu ta' sterojdi u kimoterapija u/jew fatturi ta' riskju lokali bħal infezzjoni jew trawma.
English: Taking into account the PRAC Assessment Report on the PSUR(s) for denosumab (indicated for osteoporosis and for bone loss associated with hormone ablation in prostate cancer), the scientific conclusions of CHMP are as follows:
Maltese: Meta jiġi kkunsidrat ir-Rapport ta' Valutazzjoni tal-PRAC dwar il-PSUR(s) għal denosumab (indikat għal osteoporożi u għat-telf ta' għadam assoċjat ma' asportazzjoni tal-ormoni fil-kanċer tal-prostata), il-konklużjonijiet xjentifiċi tas-CHMP huma kif ġej:
English: Prolia is not recommended for children and adolescents under 18 years of age.
Maltese: Prolia mhux rakkomandat għal tfal u adolexxenti b'età inqas minn 18-il sena.
English: Patients received calcium (at least 1,000 mg) and vitamin D (at least 800 IU) supplementation daily.
Maltese: Il-pazjenti rċevew supplimenti kuljum ta' kalċju (tal-inqas 1,000 mg) u vitamina D (tal-inqas 800 IU).
English: The additive effect of concomitantly administered products containing sorbitol (or fructose) and dietary intake of sorbitol (or fructose) should be taken into account.
Maltese: Għandhom jitqiesu l-effett addittiv ta' prodotti amministrati flimkien li fihom is-sorbitol (jew il-fructose) u l-konsum djetetiku ta' sorbitol (jew fructose).
English: 0-1 year
Maltese: 0-sentejn
English: Prevention of the RANKL/RANK interaction inhibits osteoclast formation, function and survival, thereby decreasing bone resorption in cortical and trabecular bone.
Maltese: Il-prevenzjoni tal-interazzjoni RANKL/RANK tinibixxi lformazzjoni, il-funzjoni u s-sopravivenza tal-osteoklast, u b'hekk tnaqqas l-assorbiment mill-ġdid talgħadam f'għadam kortikali kif ukoll trabekulari.
English: • To avoid discomfort at the site of injection, allow the pre-filled syringe to reach room temperature (up to 25°C) before injecting and inject slowly.
Maltese: • Biex jiġi evitat uġigħ fis-sit tal-injezzjoni, ħalli s-siringa mimlija għal-lest tilħaq temperatura tal-kamra (sa 25°C) qabel tinjetta u injetta bil-mod.
English: Push the plunger with a slow constant pressure, always keeping the skin pinched.
Maltese: IMBOTTA l-planġer bil-mod u bi pressjoni konstanti sakemm tħoss u tisma “tfaqqiha”.
English: Pharmacotherapeutic group: Drugs for the treatment of bone diseases - Other drugs affecting bone structure and mineralisation, ATC code: M05BX04
Maltese: Mediċini għat-trattament ta' mard tal-għadam - Mediċini oħra li għandhom effett fuq l-istruttura tal-għadam u l-mineralizzazzjoni, Kodiċi ATC:
English: Prolia significantly increased BMD at all clinical sites measured, relative to placebo at 12 months: 4.8% at lumbar spine, 2.0% at total hip, 2.2% at femoral neck, 2.3% at hip trochanter, and 0.9% at distal 1/3 radius (all p < 0.05).
Maltese: Meta mqabbel ma' trattament bi plaċebo Prolia żied il-BMD fis-siti kliniċi mkejla kollha b'mod sinifikanti wara 12-il xahar: fl-ispina lombari b'4.8%, fil-ġenbejn totali b'2.0%, fl-għonq tal-wirk b'2.2%, fit-trochanter tal-ġenbejn b'2.3%, fid-distal 1/3 radius b'0.9% (kollha p < 0.05).
English: Once removed from the refrigerator, Prolia may be stored at room temperature (up to 25°C) for up to 30 days in the original container.
Maltese: Ladarba jitneħħa mill-friġġ, Prolia jista' jinħażen f'temperatura tal-kamra (sa 25°C) għal perjodu sa 30 ġurnata fil-kontenitur oriġinali.
English: • bone loss that results from a reduction in hormone (testosterone) level caused by surgery or treatment with medicines in patients with prostate cancer.
Maltese: • telf ta' għadam ikkawżat minn tnaqqis fil-livell tal-ormoni (testosterone) ikkawżat minn kirurġija jew trattament b'mediċini f'pazjenti b'kanċer tal-prostata.
English: In neonatal rats, inhibition of RANKL (target of denosumab therapy) with high doses of a construct of osteoprotegerin bound to Fc (OPG-Fc) was associated with inhibition of bone growth and tooth eruption.
Maltese: F'firien tat-twelid, l-inibizzjoni ta' RANKL (il-mira ta' terapija b'denosumab) b'dożi għolja ta' sustanza magħmula minn osteoprotegerin imwaħħal ma' Fc (OPG-Fc) kienet assoċjata ma' inibizzjoni tat-tkabbir tal-għadam u ħruġ ta' snien.
English: • potency of the medicinal product that inhibits bone resorption (higher risk for highly potent compounds), route of administration (higher risk for parenteral administration) and cumulative dose of bone resorption therapy.
Maltese: • qawwa tal-prodott mediċinali li jinibbixxi assorbiment mill-ġdid tal-għadam (riskju ogħla għal komposti potenti ħafna), ir-rotta tal-għoti (riskju ogħla għal għoti parenterali) u d-doża kumulattiva ta' terapija għall-assorbiment mill-ġdid tal-għadam.
English: Once your syringe has been left to reach room temperature (up to 25°C), it must be used within 30 days.
Maltese: La darba s-siringa titħalla tilħaq temperatura tal-kamra (sa 25°C), għandha tintuża fi żmien 30 ġurnata.
English: In single and repeated dose toxicity studies in cynomolgus monkeys, denosumab doses resulting in 100 to 150 times greater systemic exposure than the recommended human dose had no impact on cardiovascular physiology, male or female fertility, or produced specific target organ toxicity.
Maltese: Fi studji dwar l-effett tossiku minn doża waħda u minn dożi ripetuti f'xadini cynomolgus, dożi ta' denosumab li jwasslu għall-esponiment sistemiku minn 100 darba sa 150 darba ogħla mid-doża rakkomandata fil-bniedem ma kellhom l-ebda effett fuq il-fiżjoloġja kardjovaskulari, il-fertilità maskili jew femminili, u ma wasslux għal tossiċità speċifika tal-organi mmirati.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Prolia 60 mg injection denosumab
Maltese: Injezzjoni li jmiss Prolia 60 mg Injezzjoni denosumab
English: A new Prolia pre-filled syringe
Maltese: Għalxiex jintuża Prolia
English: In postmenopausal women with osteoporosis the pharmacokinetics and pharmacodynamics of denosumab were not altered by previous alendronate therapy, based on data from a transition study (alendronate to denosumab).
Maltese: Ibbażat fuq data minn studju ta' transizzjoni (alendronate għal denosumab), f'nisa wara l-menopawsa b'osteoporożi, il-farmakokinetika u l-farmakodinamika ta' denosumab ma nbidlux permezz ta' terapija minn qabel b'alendronate.
English: Most of the fractures occurred in the GC-C subpopulation.
Maltese: Il-parti kbira tal-ksur seħħ fis-subpopolazzjoni GC-C.
English: Hepatic impairment
Maltese: Infezzjonijiet fil-ġilda
English: Bone biopsy results showed bone of normal architecture and quality with no evidence of mineralisation defects, woven bone or marrow fibrosis.
Maltese: Riżultati tal-bijopsija tal-għadam miż-żewġ studji wrew għadam ta' arkitettura u kwalità normali bl-ebda evidenza ta' difetti ta' mineralizzazzjoni, għadam minsuġ jew fibrożi tal-mudullun.
English: Patients were randomised (1:1) to receive either Prolia 60 mg subcutaneously once every 6 months or oral risedronate 5 mg once daily (active control) for 2 years.
Maltese: Il-pazjenti ġew randomizzati (1:1) biex jirċievu jew Prolia 60 mg taħt il-ġilda darba kull 6 xhur jew risedronate orali 5 mg darba kuljum (kontroll attiv) għal sentejn.
English: Musculoskeletal pain, including severe cases, has been reported in patients receiving Prolia in the post-marketing setting.
Maltese: Uġigħ muskoluskeletriku, inklużi każijiet gravi, kien irrappurtat f'pazjenti li kienu qed jirċievu Prolia fl-ambjent ta' wara t-tqegħid fis-suq.
English: For a more comfortable injection, leave the pre-filled syringe at room temperature for about 30 minutes before injecting.
Maltese: Għal injezzjoni aktar komda, ħalli is-siringa mimlija għal-lest fit-temperatura tal-kamra għal madwar 30 minuta qabel tinjetta.
English: Fifty nine women participated in the bone biopsy sub-study at month 24 (n = 41) and/or month 84 (n = 22) of the extension study in postmenopausal women with osteoporosis.
Maltese: Disgħa u ħamsin mara pparteċipaw fis-sottostudju tal-bijopsija tal-għadam f'xahar 24 (n = 41) u/jew xahar 84 (n = 22) tal-istudju ta' estensjoni f'nisa wara l-menopawsa b'osteoporożi.
English: In an interaction study, Prolia did not affect the pharmacokinetics of midazolam, which is metabolised by cytochrome P450 3A4 (CYP3A4).
Maltese: Fi studju ta' interazzjoni, Prolia ma kellux effett fuq il-farmakokinetika ta' midazolam, li huwa metabolizzat miċ-ċitokroma P450
English: The needle cover of the pre-filled syringe contains dry natural rubber (a derivative of latex), which may cause allergic reactions.
Maltese: L-għatu tal-labra tas-siringa mimlija għal-lest fih lastku naturali niexef (derivattiv ta' latex), li jista' jikkawża reazzjonijiet allerġiċi.
English: Bone histology in postmenopausal women and men with osteoporosis
Maltese: Istoloġija tal-għadam f'nisa wara l-menopawsa u rġiel bl-osteoporożi
English: Its metabolism and elimination are expected to follow the immunoglobulin clearance pathways, resulting in degradation to small peptides and individual amino acids.
Maltese: Il-metaboliżmu u leliminazzjoni tiegħu huma mistennija li jsegwu ir-rotot ta' tneħħija tal-immunoglobulini li jwasslu għal degradazzjoni għal peptidi żgħar u aċidi amminiċi ndividwali.
English: A dental examination with preventive dentistry and an individual benefit-risk assessment is recommended prior to treatment with denosumab in patients with concomitant risk factors.
Maltese: F'pazjenti maħsuba li għandhom ksur mhux tipiku tal-wirk, għandu jiġi kkunsidrat twaqqif tat-terapija bi Prolia sakemm il-pazjent issirlu evalwazzjoni, fuq bażi ta' stima individwali ta' benefiċċju u riskju.
English: Every 6 months Amgen Europe B.V.
Maltese: Amgen Europe B.V.
English: Syringe safety guard
Maltese: Molla tas-sigurtà tallabra
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each pre-filled syringe contains 60 mg of denosumab in 1 mL of solution (60 mg/mL).
Maltese: Kull siringa mimlija għal-lest fiha 60 mg ta' denosumab f'1 mL ta' soluzzjoni (60 mg/mL).
English: Clinical vertebral fracture
Maltese: Infezzjoni fil-widna
English: In men with prostate cancer receiving hormone ablation, Prolia significantly reduces the risk of vertebral fractures.
Maltese: F'irġiel b'kanċer tal-prostata li qed jirċeivu asportazzjoni tal-ormoni, Prolia inaqqas b'mod sinifikanti r-riskju ta' ksur vertebrali.
English: Upon re-initiation, reductions in CTX by denosumab were similar to those observed in patients initiating primary denosumab treatment.
Maltese: Hekk kif jerġa' jinbeda, it-tnaqqis f'CTX minn denosumab kien simili għal dak osservat f'pazjenti li bdew trattament primarju b'denosumab.
English: Unusual thigh bone fractures
Maltese: Effetti fuq ksur vertebrali
English: Each pack contains one pre-filled syringe with a needle guard.
Maltese: Kull pakkett fih siringa waħda mimlija għal-lest bi protezzjoni tal-labra.
English: The incidence of hip fracture was 1.2% in the placebo group compared to 0.7% in the Prolia group at 3 years.
Maltese: L-inċidenza ta' ksur tal-ġenbejn kienet ta' 1.2% fil-grupp tal-plaċebo meta mqabbel ma' 0.7% fil-grupp ta' Prolia wara 3 snin.
English: Important Before you use a Prolia pre-filled syringe with automatic needle guard, read this important information:
Maltese: Qabel tuża Prolia siringa mimlija għal-lest li għandha protezzjoni awtomatika tal-labra, aqra din l-informazzjoni important:
English: • Belly, except for a 5 cm (2-inch) area right around your belly button.
Maltese: • Iż-żaqq, ħlief il-parti ta' 5 cm (2 pulzieri) mad-dawra taż-żokra.
English: Denosumab pharmacokinetics were not affected by the formation of binding antibodies to denosumab and were similar in men and women.
Maltese: Il-farmakokinetika ta' denosumab ma kinitx affettwata mill-formazzjoni ta' antikorpi li jeħlu ma' denosumab u kienet simili fl-irġiel u fin-nisa.
English: Rarely, patients receiving Prolia may have low calcium levels in the blood (hypocalcaemia).
Maltese: Rarament, pazjenti li jkunu qed jirċievu Prolia jista' jkollhom livelli baxxi ta' kalċju fid-demm (ipokalċimija).
English: Long-term antiresorptive treatment (including both denosumab and bisphosphonates) may contribute to an increased risk for adverse outcomes such as osteonecrosis of the jaw and atypical femur fractures due to significant suppression of bone remodelling (see section 4.2).
Maltese: Trattament fit-tul kontra l-assorbiment mill-ġdid (inklużi kemm denosumab kif ukoll bisphosphonates) jista' jikkontribwixxi għal riskju akbar ta' riżultati avversi bħal osteonekrosi tax-xedaq u ksur mhux tipiku tal-wirk minħabba soppressjoni sinifikanti ta' immudellar mill-ġdid tal-għadam (ara sezzjoni 4.2).
English: NAME OF THE MARKETING AUTHORISATION HOLDER Amgen Europe B.V.
Maltese: Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq Amgen Europe B.V.
English: Adequate intake of calcium and vitamin D is important in all patients.
Maltese: Teħid adegwat ta' kalċju u vitamina D huwa importanti fil-pazjenti kollha.
English: Standard tests to investigate the genotoxicity potential of denosumab have not been evaluated, since such tests are not relevant for this molecule.
Maltese: Testijiet stàndard biex jinvestigaw il-potenzjal ġenotossiku ta' denosumab ma kinux evalwati, peress li testijiet bħal dawn mhux rilevanti għal din il-molekola.
English: • have cancer.
Maltese: • għandek kanċer.
English: In the osteoporosis clinical trial program, atypical femoral fractures were reported rarely in patients treated with Prolia (see section 4.4).
Maltese: Fil-programm ta' provi kliniċi dwar l-osteoporożi, ksur mhux tipiku tal-wirk kien irrappurtat b'mod rari f'pazjenti trattati bi Prolia (ara sezzjoni 4.4).