FrancophonIA/ELRC3.0 huggingface dataset:
English: Each patch surface is stamped with T001.
Maltese: T001.
English: There were no significant differences in serum estradiol and estrone levels in patients treated with Livensa for up to 52 weeks compared to baseline.
Maltese: Ma kien hemm l-ebda differenzi sinifikanti fl-estradiol tas-serum u fil-livelli ta' estrone f'pazjenti trattati b'Livensa sa 52 ġimgħa meta mqabbla mal-linja bażi.
English: 8 transdermal patches
Maltese: .8 Effetti mhux mixtieqa
English: Testosterone is mainly excreted in the urine as glucuronic and sulphuric acid conjugates of testosterone and its metabolites.
Maltese: Eliminazzjoni Testosterone jitneħħa primarjament fl-awrina bħala konjugati tal-glucuronic u sulphuric acid tat testosterone u l-metaboliti tiegħu.
English: Breast cyst, clitoral engorgement, enlarged clitoris, genital pruritus, vaginal burning sensation
Maltese: Uġigħ fis-sider Ċesti fis-sider, nefħa fil-klitoris, tkabbir tal-klitoris, ħakk ġenitali, sensazzjoni ta' ħruq filvaġina
English: HOW TO STORE LIVENSA
Maltese: Tużax Livensa
English: The recommended daily dose of testosterone is 300 micrograms.
Maltese: Id-doża rakkomandata ta' kuljum ta' testosterone hi ta' 300 mikrogramma.
English: Efficacy versus placebo was significant across a range of subgroups which included patients separated by the following baseline characteristics: age (all subgroups up to age 65 years); body weight (up to 80 kg) and oophorectomy (up to 15 years ago).
Maltese: L-effikaċja kontra l-plaċebo kienet sinifikanti fuq medda ta' sotto-gruppi li kienu jinkludu pazjenti separati skond il-karatteristiċi tal-linja bażi li ġejjin: età (is-sotto-gruppi kollha sa l-età ta' 65 sena); piż tal-ġisem (sa 80 kg) u ooforektomija (sa 15-il sena ilu).
English: - sinusitis (inflammation of nasal sinus) - abnormal clotting factor - hypersensitivity (allergic reactions) - increased appetite - agitation
Maltese: - sensittività eċċessiva (reazzjonijiet allerġiċi)
English: Livensa is indicated for the treatment of hypoactive sexual desire disorder (HSDD) in bilaterally oophorectomised and hysterectomised (surgically induced menopause) women receiving concomitant estrogen therapy.
Maltese: Livensa hu indikat għat-trattament ta' mard li fih persuna jkollha nuqqas ta' xewqa sesswali (hypoactive sexual desire disorder, HSDD) f'nisa li kellhom ooforektomija u isterektomija b'mod bilaterali (menopawsa ikkaġunata b'mod kirurġiku) li kienu qed jirċievu terapija bl-estroġenu fl-istess ħin.
English: In women, who have undergone bilateral oophorectomy, serum levels of testosterone decline by approximately 50 % within days after surgery.
Maltese: F'nisa li kellhom ooforektomija bilaterali, il-livelli fis-serum ta' testosterone jonqsu b'madwar 50% fi ftit jiem wara l-operazzjoni.
English: Data in the literature regarding the influence of testosterone on the risk of breast cancer in women are limited, inconclusive and conflicting.
Maltese: Informazzjoni fil-letteratura dwar l-influwenza tat-testosterone fuq ir-riskju ta' kanċer tas-sider fin-nisa hi limitata, mhux konklużiva u konfliġġenti.
English: ANNEX II A. MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE
Maltese: DETENTUR(I) TA' L-AWTORIZZAZZJONI TAL-MANIFATTURA RESPONSABBLI
English: Backing layer
Maltese: Reazzjoni fisapplikazzjoni
English: Livensa is designed to systemically deliver 300 micrograms/day.
Maltese: Livensa hu maħsub biex iforni b'mod sistemiku, 300 mikrogramma kuljum.
English: Disturbance in attention, dysgeusia, impaired balance, hyperaesthesia, oral paraesthesia, transient ischemic attack
Maltese: Disturbi fl-attenzjoni, indeboliment fis-sens tat togħma, indeboliment fis-sens tal-bilanċ, iperestesija,
English: Fertility No data is available of the effect of Livensa on fertility.
Maltese: Fertilità M'hemm l-ebda dejta dwar l-effett ta' Livensa fuq il-fertilità.
English: During 6-month double blind exposure the following adverse reactions occurred in the treatment group (n=549) at a greater incidence than placebo (n=545) and were assessed by the investigators as possibly or probably related to Livensa treatment.
Maltese: Matul l-espożizzjoni double blind għal 6 xhur, ir-reazzjonijiet avversi li ġejjin seħħew fil-grupp tattrattament (n=549) f'inċidenza akbar milli fil-grupp tal-plaċebo (n=545) u kienu evalwati mill investigaturi bħala possibbilment jew probabbilment relatati mat-trattament ta' Livensa.
English: Anasarca, asthenia, chest tightness, chest discomfort
Maltese: IL-KONTENUT SKOND IL-PIŻ, VOLUM, JEW PARTI
English: DHT concentrations increased in parallel with testosterone concentrations during Livensa treatment.
Maltese: Il-konċentrazzjonijiet tad-DHT żdiedu b'mod parallel mal-konċentrazzjonijiet ta' testosterone matul it-trattament b'Livensa.
English: Transdermal patch.
Maltese: - ħalq xott
English: DHT has a greater affinity to SHBG than does testosterone.
Maltese: DHT għandu affinità akbar għal SHBG milli għandu t-testosterone.
English: Testosterone is metabolised primarily in the liver.
Maltese: Testosterone hu metabolat primarjament fil-fwied.
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu
Maltese: Informazzjoni dettaljata dwar din il-mediċina tinsab fuq is-sit elettroniku ta' l-Aġenzija Ewropeja dwar il-Mediċini http://www.ema.europa.eu.
English: Testosterone from Livensa is transported across intact skin by a passive diffusion process that is primarily controlled by permeation across the stratum corneum.
Maltese: Testosterone minn Livensa, jiġi ttrasportat minn ġol-ġilda intatta permezz ta' proċess passiv tad diffużjoni, li huwa primarjament ikkontrollat mix-xterid minn naħa għal oħra ta' l-istratum corneum.
English: The active substance is released from the patch constantly over 3 to 4 days (corresponding to 300 micrograms per 24 hours) and is absorbed through your skin.
Maltese: Is-sustanza attiva tintreħa mill-garża l-ħin kollu fuq perjodu ta' 3 sa 4 ijiem (li tikkorrisponi għal 300 mikrogramma kull 24 siegħa) u tiġi assorbita minn ġol-ġilda tiegħek.
English: The off-label use is a safety risk.
Maltese: L-użu off-label hu riskju għas-sigurtà.
English: Agitation, anxiety
Maltese: - ansjetà - disturbi fl-attenzjoni
English: The limited data evaluating the effect of testosterone on the endometrium neither allow conclusions nor reassurances on the incidence of endometrial cancer.
Maltese: L-informazzjoni limitata li tevalwa l-effett ta' testosterone fuq l-endometriju, la tippermetti konklużjonijiet u lanqas assigurazzjonijiet dwar l-inċidenza ta' kanċer endometrijali.
English: - Medicines should not be disposed of via wastewater (do not flush it down the toilet) or household waste.
Maltese: - Il-mediċini m'għandhomx jintremew ma' l-ilma tad-dranaġġ (tifflaxxjahomx fit-toilet) jew ma' l-iskart domestiku.
English: Two multi-centre, double-blind, placebo-controlled six month studies in 562 (INTIMATE SM1) and 533 (INTIMATE SM2) oophorectomised and hysterectomised women (surgically induced menopause), aged 20 to 70 years, with HSDD on concomitant estrogen were used to evaluate the efficacy and safety of Livensa.
Maltese: (menopawsa ikkaġunata b'mod kirurġiku), li kellhom minn 20 sa 70 sena, bl-HSDD u bl-użu fl-istess ħin ta' l-estroġenu, intużaw biex tiġi evalwata l-effikaċja u s-sigurtà ta' Livensa.
English: There is little information on long-term safety, including effects on breast tissue, the cardiovascular system and increase in insulin resistance.
Maltese: Hemm ftit informazzjoni dwar is-sigurtà fuq tul ta' żmien, li tinkludi effetti fuq it-tessut tas-sider, is-sistema kardjovaskulari u żieda fir-reżistenza għall-insulina.
English: Diplopia, eye redness
Maltese: TWISSIJA(IET) SPEĊJALI
English: Testosterone has been found to be nongenotoxic.
Maltese: Testosterone nstab li kien mhux ġenotossiku.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each patch of 28 cm2 contains 8.4 mg testosterone and provides 300 micrograms of testosterone per 24 hours.
Maltese: Kull garża ta' 28 ċm2 fiha 8.4 mg ta' testosterone u tipprovdi 300 mikrogramma ta' testosterone kull
English: Livensa is intended for use by women up to the age of 60 years who have had both their ovaries and their womb removed.
Maltese: Livensa hu intenzjonat għall-użu minn nisa li għandhom sa 60 sena li kellhom iż-żewġ ovarji u l-utru tagħhom imneħħija.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON (Box of 2, 8 or 24 patches)
Maltese: KARTUNA TA' BARRA (Kaxxa ta' 2, 8 jew 24 garżi)
English: 1 patch of 28 cm2 contains 8.4 mg of testosterone and provides 300 micrograms per 24 hours.
Maltese: Kull garża fiha 8.4 mg ta' testosterone, li terħi 300 mikrogramma ta'
English: Abnormal blood fibrinogen, increased heart rate, increased alanine aminotransferase, increased aspartate aminotransferase, increased blood bilirubin, abnormal liver function test, increased blood triglycerides
Maltese: Żieda fil-piż Fibrinoġen anormali fid-demm, żieda fir-rata ta' taħbit tal-qalb, żieda f'alanine aminotransferase, żieda f'aspartate aminotransferase, żieda fil-bilirubina fid-demm, test anormali tal-funzjoni talfwied, żieda fit-triglycerides fiddemm
English: It is not known whether Livensa increases the risk of breast cancer and endometrium cancer.
Maltese: Mhux magħruf jekk Livensa jżidx ir-riskju ta' kanċer tas-sider u kanċer tal-endometriju.
English: Testosterone may induce virilising effects on the female foetus when administered to a pregnant woman.
Maltese: Testosterone jista' jikkaġuna effetti virilising fuq il-fetu femminili meta jingħata lil mara tqila.
English: Voice deepening
Maltese: - aġitazzjoni
English: Other uncommon side effects Most of them are mild in nature and reversible.
Maltese: Ħafna minnhom huma ħfief u riversibbli.
English: Transdermal use
Maltese: TAL-PRODOTT
English: NAME OF THE MEDICINAL PRODUCT Livensa 300 micrograms/24 hours transdermal patch Testosterone
Maltese: TAL-PRODOTT MEDIĊINALI Livensa 300 mikrogramma/24 siegħa garża li tipprovdi mediċina li tgħaddi minn ġol-ġilda
English: The safety of Livensa has not been evaluated in double blind placebo controlled studies of longer than 1 year duration.
Maltese: Is-sigurtà ta' Livensa ma kinitx evalwata fi studji double blind ikkontrollati bil-plaċebo li damu iktar minn sena.
English: 24 transdermal patches
Maltese: Twissijiet speċjali
English: Hirsutism Acne, alopecia Eczema, increased sweating, rosacea
Maltese: Anasarka, astenja, dwejjaq fissider, skonfort fis-sider
English: A responder analysis of the pivotal phase II and III studies showed significant improvements in all three major clinical endpoints versus placebo in patients on concomitant transdermal and oral non-CEE estrogens.
Maltese: Analiżi ta' dawk li rrispondew fil-fażi importanti ħafna II u III ta' l-istudju, uriet titjib sinifikanti fit-tliet riżultati aħħarin kliniċi maġġuri kontra l-plaċebo f'pazjenti li kienu qed jużaw l-estroġeni non-CEE orali u transdermali fl-istess ħin.
English: Then continue with your regular schedule of patch-change days, even if this means discarding a patch after you have worn it for less than 3-4 days.
Maltese: Imbagħad kompli bl-iskeda regolari tiegħek tal-jiem li fihom tibdel il-garża, anki jekk dan ifisser li tarmi garża wara li tkun ilha fuqek għal inqas minn 3-4 ijiem.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 28-July-2006
Maltese: Data ta' l-ewwel awtorizzazzjoni: 28 ta' Lulju, 2006
English: Nasal congestion, throat tightness
Maltese: - tkabbir tal-klitoris
English: Elderly
Maltese: Bondoufle
English: Paediatric population There is no relevant use of Livensa in the paediatric population.
Maltese: M'hemmx użu rilevanti għall-użu ta' Livensa fil-popolazzjoni pedjatrika.
English: Most reports concerned the chin and upper lip, were mild (≥ 90 %), and less than 1 % of all patients withdrew from the studies due to hirsutism.
Maltese: Il-biċċa l-kbira tar-rapporti li kienu jikkonċernaw l-ilħit jew in-naħa ta' fuq tax-xufftejn, kienu ħfief (≥ 90%), u inqas minn 1% tal-pazjenti kollha irtiraw mill-istudji minħabba xagħar li jikber b'mod eċċessiv u f'postijiet mhux tas-soltu.
English: Application site reaction (erythema, itching)
Maltese: DHT (ng/dl)
English: Warner Chilcott Deutschland GmbH Dr.-Otto-Röhm-Strasse 2-4 64331 Weiterstadt Germany
Maltese: Dr.-Otto-Röhm-Strasse 2-4
English: However, the subgroup of patients receiving oral CEE did not demonstrate a significant improvement in sexual activity compared to placebo (see sections 4.2 and 4.4).
Maltese: Madankollu, is-sotto-grupp tal-pazjenti li kienu qed jirċievu CEE orali, ma weriex titjib sinifikanti fl-attività sesswali meta mqabbel mal-plaċebo (ara sezzjonijiet 4.2 u 4.4).
English: Livensa should not be used in women on concomitant CEE Whereas Livensa is indicated with concomitant estrogen therapy, the subgroup of patients receiving oral conjugated equine estrogens (CEE) did not demonstrate a significant improvement in sexual function.
Maltese: pazjenti li kienu qed jirċievu conjugated equine estrogens (CEE) orali, ma wrewx titjib sinifikanti fil funzjoni sesswali.
English: Severe skin erythema, local oedema and blistering may occur due to hypersensitivity to the patch at the site of application.
Maltese: Eritema severa tal-ġilda, edema lokali u nfafet jistgħu jseħħu minħabba s-sensittività eċċessiva għallgarża fis-sit ta' applikazzjoni.
English: Step 2 While holding the patch, remove half of the protective liner that covers the sticky part of the patch.
Maltese: Pass 2 Waqt li tkun qed iżżomm l-garża, neħħi nofs l-inforra protettiva li tkun tiksi l-parti li twaħħal tal-garża.
English: Testosterone has a masculinising effect on female rat foetuses when dosed subcutaneously at 0.5 or 1 mg/day (as the propionate ester) to pregnant rats during organogenesis.
Maltese: Testosterone għandu effett li jimmaskilizza fuq feti femminili tal-firien meta ngħataw id-doża taħt il ġilda b'0.5 jew 1 mg kuljum (bħala l-propionate ester) lil firien tqal matul l-organoġenesi.
English: The ethylene methacrylic acid copolymer (Surlyn) is the heat seal layer which allows the two laminate sachet stocks to be heat-sealed together to form the sachet.
Maltese: Ethylene methacrylic acid copolymer (Surlyn) hu saff issiġillat bis-sħana li jippermetti ż-żewġ stocks laminati tal-qartas li jkunu ssiġillati flimkien bis-sħana biex jiffurmaw il-qartas.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Livensa 300 micrograms/24 hours transdermal patch Testosterone
Maltese: IL-PRODOTT MEDIĊINALI Livensa 300 mikrogramma/24 siegħa garża li tipprovdi mediċina li tgħaddi minn ġol-ġilda
English: Breast pain
Maltese: Disturbi psikjatriċi
English: Serum concentrations of testosterone and SHBG in patients receiving Livensa in clinical safety and
Maltese: Il-konċentrazzjonijiet fis-serum tat-testosterone u SHBG f'pazjenti li kienu qed jirċievu Livensa fi studji kliniċi dwar is-sigurtà u l-effikaċja
English: What Livensa contains
Maltese: LivensTqala u treddigħ
English: Oedema may be a serious complication from high doses of testosterone, however, this is not expected from low dose of testosterone delivered by the Livensa patch.
Maltese: Madankollu, dan mhuwiex mistenni minħabba doża baxxa ta' testosterone fornuta mill-garża ta' Livensa.
English: Date of latest renewal: 20th November 2018
Maltese: Data tal-aħħar tiġdid: 20 ta 'Novembru 2018
English: NR 714
Maltese: MM 714
English: • Confusion.
Maltese: • Konfużjoni.
English: • Urticaria.
Maltese: • Urtikarja.
English: Renal impairment TIH:
Maltese: Indeboliment tal-kliewi TIH:
English: 319 Pinner Road North Harrow Middlesex, HA1 4HF United Kingdom
Maltese: 319 Pinner Road North Harrow Middlesex, HA1 4HF
English: Acquired Fanconi syndrome
Maltese: Sindrome Fanconi Akkwiżita
English: Risk reduction of suffering from multiple events** (%)
Maltese: Tnaqqis ta' riskju li wieħed jiżviluppa ħafna avvenimenti f'daqqa** (%)
English: Table 6: Adverse reactions observed in paediatric patients with severe osteogenesis imperfecta1
Maltese: Tabella 6: Reazzjonijiet avversi osservati f'pazjenti pedjatriċi b'osteoġenesi imperfetta severa1
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 16.01.2014
Maltese: Data tal-ewwel awtorizzazzjoni: 16.01.2014
English: EU/1/13/834/002
Maltese: EU/1/13/834/001 EU/1/13/834/002 EU/1/13/834/003
English: 319, Pinner Road North Harrow, Middlesex HA1 4HF United Kingdom
Maltese: Sage House 319, Pinner Road North Harrow, Middlesex HA1 4HF Ir-Renju Unit
English: Excipients: mannitol (E421), sodium citrate and water for injections.
Maltese: Eċċipjenti: mannitol (E421), sodium citrate u ilma għall-injezzjonijiet.
English: Zoledronic acid 4 mg (N=86) 45.3% (p=0.104) 82.6% (p=0.005)* 88.4% (p=0.002)* Zoledronic acid 8 mg (N=90) 55.6% (p=0.021)* 83.3% (p=0.010)* 86.7% (p=0.015)* Pamidronate 90 mg (N=99) *p-values compared to pamidronate.
Maltese: Zoledronic acid 8 mg (N=90) 55.6% (p=0.021)* 83.3% (p=0.010)* 86.7% (p=0.015)* Pamidronate 90 mg (N=99) *Valur-p mqabbel ma' pamidronate
English: NA NA NA NA
Maltese: Uġigħ ta' ras
English: • A kidney function disorder called Fanconi syndrome (will normally be determined by your doctor with certain urine tests).
Maltese: • Disturb tal-funzjoni tal-kliewi msejjaħ sindrome Fanconi (normalment se jkun iddeterminat mit tabib tiegħek permezz ta' ċerti testijiet tal-awrina).
English: Packs containing 1, 4 or 10 vials.
Maltese: Il-pakketti fihom 1, 4 jew 10 kunjetti.
English: Zoledronic Acid Accord can be given to people aged 65 years and over.
Maltese: Zoledronic Acid Accord jista' jingħata lill-persuni li għandhom 65 sena jew aktar.
English: For instructions on the dilution of zoledronic acid before administration, see section 6.6.
Maltese: Għal istruzzjonijiet fuq id-dilwizzjoni ta' zoledronic acid qabel l-amministrazzjoni, ara sezzjoni 6.6.
English: • Hypersensitivity reactions.
Maltese: • Reazzjonijiet ta' sensittività eċċessiva.
English: The total body clearance is 5.04 ± 2.5 l/h, independent of dose, and unaffected by gender, age, race, and body weight.
Maltese: It-tneħħija totali millġisem hija ta' 5.04 ±2.5 l/h, indipendenti mid-doża, u mhix affettwata minn sess, età, razza u piż talġisem.
English: Zoledronic Acid Accord is supplied as packs containing 1, 4 or 10 vials.
Maltese: Zoledronic Acid Accord jiġi f'pakketti ta' 1, 4 jew 10 kunjetti.
English: Baseline creatinine clearance (ml/min) Zoledronic acid recommended dose* 4.0 mg zoledronic acid 3.5 mg* zoledronic acid 3.3 mg* zoledronic acid 3.0 mg* zoledronic acid * Doses have been calculated assuming target AUC of 0.66 (mg-hr/l) (CLcr = 75 ml/min).
Maltese: 4.0 mg zoledronic acid 3.5 mg* zoledronic acid 3.3 mg* zoledronic acid 3.0 mg* zoledronic acid * Id-dożi ġew ikkalkulati billi tqieset mira ta' AUC ta' 0.66 (mg-hr/l) (CLcr=75 ml/min).
English: Manufacturer Accord Healthcare Limited Sage House
Maltese: Manifattur Accord Healthcare Limited
English: Dizziness,
Maltese: Insuffiċjenza epatika
English: Pain in extremities, arthralgia, musculoskeletal pain
Maltese: Uġigħ fl-idejn u s-saqajn, artralġja, uġigħ muskoluskelettriku
English: The effects of intravenous zoledronic acid in the treatment of paediatric patients (age 1 to 17 years) with severe osteogenesis imperfecta (types I, III and IV) were compared to intravenous pamidronate in one international, multicentre, randomised, open-label study with 74 and 76 patients in each treatment group, respectively.
Maltese: L-effetti ta' zoledronic acid mogħti ġol-vina fil-kura ta' pazjenti pedjatriċi (mill-età ta' sena sa 17il sena) b'osteoġenesi imperfetta severa (tipi I,III u IV) tqabblu ma' pamidronate mogħti ġol-vina fi studju wieħed internazzjonali, multiċentriku, randomizzat, open labelb'74 u 76 pazjent f'kull grupp ta' kura, rispettivament.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/13/834/001- 1vial pack EU/1/13/834/002- 4 vial pack EU/1/13/834/003- 10 vial pack
Maltese: EU/1/13/834/001-1 kunjetti EU/1/13/834/002-4 kunjetti EU/1/13/834/003-10 kunjetti
English: • Flu-like symptoms including arthritis and joint swelling.
Maltese: • Sintomi jixbħu lill-influwenza inkluż artrite u nefħa fil-ġogi.
English: Fracture adverse events of long bones in the lower extremities were reported in approximately 24% (femur) and 14% (tibia) of zoledronic acid-treated patients vs 12% and 5% of pamidronate-treated patients with severe osteogenesis imperfecta, regardless of disease type and causality but overall incidence of fractures was comparable for the zoledronic acid and pamidronate-treated patients: 43% (32/74) vs 41% (31/76).
Maltese: Każijiet avversi ta' ksur fl-għadam twil tar-riġel kienu rrappurtati f'madwar 24% (femur) u 14% (tibia) ta' pazjenti li kellhom osteoġenesi imperfetta severa kkurati b'zoledronic acid kontra12% u 5% ta' pazjenti kkurati b'pamidronate, kienet x'kienet it-tip ta' marda u l-kawża tagħha iżda l-inċidenza globali ta' ksur kienet kumparabbli mal-pazjenti kkurati b'zoledronic acid u pamidronate: 43% (32/74) kontra41% (31/76).
English: Rare (1/10,000 to <1/1,000)
Maltese: Rari ( 1/10,000 sa < 1/1,000)
English: Zoledronic Acid Accord contains sodium
Maltese: Zoledronic Acid Accord fih sodium
English: 4 vials
Maltese: 4 Ġurnata
English: Hypophosphataemia 1 Adverse events occurring with frequencies < 5% were medically assessed and it was shown that these cases are consistent with the well established safety profile of zoledronic acid (see section 4.8)
Maltese: Ipofosfatimija 1 Reazzjonijiet avversi li seħħew bi frekwenzi < 5% kienu stmati b'mod mediku u ntwera li dawn il każijiet kienu konsistenti mal-profil ta' sigurtà stabbilit tajjeb ta' zoledronic acid (ara sezzjoni 4.8).
English: Chemical and physical in-use stability has been demonstrated for 36 hours at 2 - 8 °C.
Maltese: L-istabilità kimika u fiżika waqt l-użu intweriet għal 36 siegħa f'temperatura ta' bejn 2 -8°C.
English: • The solution containing zoledronic acid is given as a single 15-minute intravenous infusion in a separate infusion line.
Maltese: • Is-soluzzjoni ta' zoledronic acid tingħata darba bħala infużjoni ġol-vini fuq medda ta' 15-il minuta f'pajp separat għall-infużjoni.
English: In clinical studies, zoledronic acid has been administered concomitantly with commonly used anticancer agents, diuretics, antibiotics and analgesics without clinically apparent interactions occurring.
Maltese: Fi studji kliniċi, zoledronic acid ngħata flimkien ma' mediċini li jintużaw ta' spiss kontra l-kanċer, dijuretiċi, antibijotiċi u analġeżiċi, mingħajr ma kien hemm interazzjonijiet li kienu klinikament evidenti.
English: In the clinical trials, renal deterioration was defined as follows: For patients with normal baseline serum creatinine (< 1.4 mg/dl or < 124 µmol/l), an increase of 0.5 mg/dl or 44 µmol/l; For patients with abnormal baseline creatinine (> 1.4 mg/dl or > 124 µmol/l), an increase of 1.0 mg/dl or 88 µmol/l.
Maltese: Għall-pazjenti b'linja bażi anormali ta' kreatinina (>1.4 mg/dl jew >124 µmol/l), żieda ta' 1.0 mg/dl jew 88 µmol/l.
English: Median time to relapse (re-increase of albumin-corrected serum calcium ≥ 2.9 mmol/l) was 30 to 40 days for patients treated with zoledronic acid versus 17 days for those treated with pamidronate 90 mg (p-values: 0.001 for 4 mg and 0.007 for 8 mg zoledronic acid).
Maltese: ≥ 2.9 mmol/l) kien ta' 30 sa 40 ġurnata għall-pazjenti fuq kura b'zoledronic acid kontra s-17-il ġurnata f'pazjenti li kienu fuq pamidronate 90 mg (valuri-p: 0.001 għal 4 mg u 0.007 għal 8 mg zoledronic acid).
English: Hypocalcaemia-related ADRs
Maltese: ADRs relatati ma' ipokalċimija
English: In clinical trials with zoledronic acid, patients with serum creatinine > 265 µmol/l or > 3.0 mg/dl were excluded.
Maltese: Fi provi kliniċi b'zoledronic acid, pazjenti b'kreatinina fis-serum ta' >265µmol/l jew > 3.0 mg/dl kienu esklużi.
English: During post-marketing experience the following reactions have been reported (frequency rare): Atypical subtrochanteric and diaphyseal femoral fractures (bisphosphonate class adverse reaction).
Maltese: Mill-esperjenza ta' wara t-tqegħid fis-suq dawn il-ġrajjiet kienu rrappurtati (frekwenza rari): ksur subtrochanteric u diaphyseal mhux tipiku tal-għadma tal-wirk (reazzjoni avversa tal-klassi talbisfosfonati).