FrancophonIA/ELRC3.0 huggingface dataset:
English: The inspection, carried out by the German, Swedish and UK medicines agencies, identified a number of critical and major findings which revealed a failure to conduct the studies in compliance with Good Clinical Practice (GCP) and seriously questioned the reliability of the study data.
Maltese: L-ispezzjoni, imwettqa minn aġenziji mediċinali Ġermaniżi, Svediżi u mir-Renju Unit, identifikat numru ta' sejbiet kritiċi u maġġuri li wrew nuqqas li l-istudji jitwettqu b'konformità mal-Prattiċi ta' Klinika Tajba (Good Clinical Practice (GCP)) u jqajmu mistoqsijiet serji dwar il-kredibilità tad-dejta tal-istudju.
English: How is Combimarv expected to work?
Maltese: Għal x'hiex kien mistenni li jintuża Combimarv?
English: What was Combimarv expected to be used for?
Maltese: Kif kien mistenni li jaħdem Combimarv?
English: The concerns over the data led the CHMP to request an inspection of Bombay Bioresearch Centre (BBRC) in India, where studies were carried out for Marvel LifeSciences (the sponsor of the studies), and also of Marvel LifeSciences's UK site.
Maltese: It-tħassib fuq id-dejta wassal lis-CHMP jitlob spezzjoni ta' Bombay Bioresearch Centre (BBRC) fl-Indja, fejn saru l-istudji għal Marvel LifeSciences (l-isponser tal-istudji), kif ukoll tassede ta' Marvel LifeSciences fir-Renju Unit.
English: The company presented the results of studies designed to show that Combimarv is similar to its reference medicine Humulin M3 in terms of its structure, biological activity and clinical performance.
Maltese: Il-kumpanija ppreżentat ir-riżultati tal-istudji ddiżinjati biex juru li Combimarv huwa simili għallmediċina ta' referenza Humulin M3 għal dak li jirrigwarda l-istruttura, l-attività bijoloġika u lprestazzjoni klinika.
English: It was to be available as a suspension for injection.
Maltese: Jiġi bħala sospensjoni għallinjezzjoni.
English: In its letter notifying the Agency of the withdrawal of application, the company stated that they decided to withdraw the applications in order to repeat the studies at a validated contract research organisation and to submit additional data.
Maltese: In-nuqqasijiet identifikati kienu tali li d-dejta mogħtija mill-kumpanija ma setgħetx tintuża biex tkun evawalta l-applikazzjoni għall-awtorizzazzjoni għattqegħid fis-suq.
English: After its initial assessment, the CHMP had significant concerns and was of the provisional opinion that Combimarv could not have been approved.
Maltese: Wara valutazzjoni inizjali, is-CHMP kellu tħassib sinifikanti u kien tal-opinjoni proviżorja li Combimarv ma jkunx jista' jiġi approvat.
English: In addition, the company presented the results from a main study in 432 patients with diabetes comparing the safety and effectiveness of the three medicines from Marvel LifeSciences with their respective reference medicines.
Maltese: Barra minn hekk, il-kumpanija ppreżentat ir-riżultati minn studju ewlieni f'432 pazjent li jbatu biddijabete u qabblet is-sigurtà u l-effikaċja tat-tliet medicini ta' Marvel LifeSciences mal-mediċini ta' referenza rispettivi.
English: Combimarv was expected to be used to treat patients with diabetes who require insulin to control their blood glucose (sugar).
Maltese: Combimarv kien mistenni li jintuża fil-kura ta' pazjenti bid-dijabete li jeħtieġu l-insulina biex jikkontrollaw il-glukożju (iz-zokkor) f'demmhom.
English: What were the reasons given by the company for withdrawing the application?
Maltese: X'raġunijiet tat il-kumpanija għall-irtirar tal-applikazzjoni?
English: The CHMP also noted problems with the study data provided by the company, including statistical errors and missing information.
Maltese: Is-CHMP innota wkoll problemi bid-dejta tal-istudju mogħtija mill-kumpanija, fosthom żbalji statistiċi u informazzjoni nieqsa.
English: Ref.: EMA/814249/2009 EMEA/H/C/1034 EMEA/H/C/1122
Maltese: EMEA/H/C/1122
English: It was to be available as capsules.
Maltese: Kellha tkun disponibbli bħala kapsuli.
English: The active substance in Milnacipran Pierre Fabre Médicament/Impulsor, milnacipran, is a ‘serotoninnoradrenaline re-uptake inhibitor'.
Maltese: Is-sustanza attiva fi Milnacipran Pierre Fabre Médicament/Impulsor, milnacipran, hija ‘inibitur tatteħid mill-ġdid tas-serotonin-noradrenaline'.
English: London, 19 November 2009 Doc.
Maltese: Londra, 19 ta' Novembru 2009 Dok. ta' Ref.: EMA/64545/2010
English: After considering the grounds for this request, the CHMP re-examined the initial opinion, and confirmed the refusal of the marketing authorisation on 19 November 2009.
Maltese: Wara li kkunsidra r-raġunijet għal din it-talba, isCHMP reġa' eżamina l-opinjoni inizjali, u kkonferma r-rifjut tal-awtorizzazzjoni għat-tqegħid fis-suq fid-19 ta' Novembru 2009.
English: Milnacipran Pierre Fabre Médicament/Impulsor is a medicine that contains the active substance milnacipran.
Maltese: Milnacipran Pierre Fabre Médicament/Impulsor hija mediċina li fiha s-sustanza attiva milnacipran.
English: What is Milnacipran Pierre Fabre Médicament/Impulsor?
Maltese: X'inhu Milnacipran Pierre Fabre Médicament/Impulsor?
English: In three main studies, 2,960 adult patients with fibromyalgia were given either Milnacipran Pierre Fabre Médicament/Impulsor or placebo (a dummy treatment) for around four to seven months.
Maltese: Fi tliet studji ewlenin, 2,960 pazjent adult b'fibromijalġija ngħataw Milnacipran Pierre Fabre Médicament/Impulsor jew plaċebo (trattament finta) għal madwar erba' sa seba' xhur.
English: On 23 July 2009, the Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion, recommending the refusal of the marketing authorisation for the medicinal product Milnacipran Pierre Fabre Médicament/Impulsor, intended for the treatment of fibromyalgia in adults.
Maltese: Fit-23 ta' Lulju 2009, il-Kumitat għal Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) adotta opinjoni negattiva, fejn irrakkomanda r-rifjut tal-awtorizzazzjoni għat-tqegħid fis-suq għall-prodott mediċinali Milnacipran Pierre Fabre Médicament/Impulsor, li kien maħsub għat-trattament talfibromijalġija fl-adulti.
English: The company that applied for authorisation is Pierre Fabre Medicament.
Maltese: Il-kumpanija li applikat għall-awtorizzazzjoni hija Pierre Fabre Medicament.
English: The CHMP was of the opinion that the effect of the medicine was marginal.
Maltese: Is-CHMP kien tal-opinjoni li l-effett tal-mediċina kien wieħed marġinali.
English: It was expected to work by preventing the neurotransmitters 5hydroxytryptamine (also called serotonin) and noradrenaline from being taken back up into nerve cells in the brain and spinal cord.
Maltese: Kienet mistennija li taħdem billi ma tħallix innewrotrażmettituri 5-hydroxytryptamine (msejħa wkoll serotonin) u noradrenaline milli jittieħdu lura fiċ-ċelluli tan-nervituri fil-moħħ u fil-korda spinali.
English: The company informed the CHMP that there are currently no ongoing clinical trials with Milnacipran Pierre Fabre Médicament/Impulsor in Europe for fibromyalgia.
Maltese: Il-kumpanija għarrfet lis-CHMP li attwalment m'hemm l-ebda prova klinika għaddejja b'Milnacipran Pierre Fabre Médicament/Impulsor fl-Ewropa għall-fibromijalġija.
English: How was Milnacipran Pierre Fabre Médicament/Impulsor expected to work?
Maltese: Kif kien mistenni li jaħdem Milnacipran Pierre Fabre Médicament/Impulsor?
English: Questions and answers on the recommendation for the refusal of the marketing authorisation for Milnacipran Pierre Fabre Médicament/Impulsor milnacipran
Maltese: Mistoqsijiet u tweġibiet dwar ir-rakkomandazzjoni għar-rifjut tal-awtorizzazzjoni għattqegħid fis-suq għal Milnacipran Pierre Fabre Médicament/Impulsor milnacipran
English: What documentation did the company present to support its application to the CHMP?
Maltese: X'dokumentazzjoni ppreżentat il-kumpanija biex tappoġġa l-applikazzjoni tagħha lis-CHMP?
English: Milnacipran Pierre Fabre Médicament/Impulsor was expected to be used to treat adults with fibromyalgia, a disease causing long-lasting, widespread pain and painful responses to touch.
Maltese: Milnacipran Pierre Fabre Médicament/Impulsor kien mistenni li jintuża għat-trattament tal-adulti li għandhom fibromijalġija, marda li tikkawża uġigħ mifrux li jdum u reazzjonijiet ta' uġigħ mal-mess.
English: The effects of Milnacipran Pierre Fabre Médicament/Impulsor were first tested in experimental models before being studied in humans.
Maltese: L-effetti ta' Milnacipran Pierre Fabre Médicament/Impulsor għall-ewwel ġew ittestjati f'mudelli sperimentali qabel ma ġew studjati fuq il-bniedem.
English: Neurotransmitters are chemicals that allow nerve cells to communicate with one another.
Maltese: In-newrotrażmettituri huma sustanzi kimiċi li jippermettu liċ-ċelluli tan-nervituri jikkomunikaw bejniethom.
English: What are the consequences of the refusal for patients in clinical trials or compassionate use programmes using Milnacipran Pierre Fabre Médicament/Impulsor?
Maltese: X'inhuma l-konsegwenzi tar-rifjut għal dawk il-pazjenti involuti fi provi kliniċi jew fi programmi ta' użu b'kumpassjoni bl-użu ta' Milnacipran Pierre Fabre Médicament/Impulsor?
English: Therefore, at that point in time, the CHMP was of the opinion that the benefits of Milnacipran Pierre Fabre Médicament/Impulsor in the treatment of fibromyalgia did not outweigh its risks.
Maltese: Għaldaqstant, f'dak iż-żmien, is-CHMP kien tal-opinjoni li l-benefiċċji ta' Milnacipran Pierre Fabre Médicament/Impulsor fit-tratttament ta' fibromijalġija ma kinux akbar mir-riskji.
English: Any SRE (+TIH)
Maltese: Kwalunkwe SRE (+TIH)
English: Placebo Δ Zometa 
Maltese: Plaċebo Δ Zometa 
English: 1.0 mg/dl or 88 µmol/l.
Maltese: 1.0 mg/dl jew 88 µmol/l.
English: Acute toxicity
Maltese: Tossiċità akuta
English: • Breast-feeding (see section 4.6).
Maltese: • Treddigħ (ara sezzjoni 4.6).
English: Thrombocytopenia, leukopenia
Maltese: Tromboċitopenija, lewkopenija
English: Subchronic and chronic toxicity
Maltese: Tossiċità sottokronika u kronika
English: Urticaria.
Maltese: Urtikarja.
English: Unopened bottle: 3 years.
Maltese: Flixkun mhux miftuħ: 3 snin.
English: 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) 33.3% *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: Risk reduction of suffering from multiple events** (%)
Maltese: Tnaqqis ta' riskju li wieħed jiżviluppa ħafna avvenimenti f'daqqa ** (%)
English: Atrial fibrillation
Maltese: Fibrillazzjoni tal-atrija
English: Episcleritis
Maltese: Episklerite
English: Zoledronic acid shows no appreciable binding to plasma proteins and does not inhibit human P450 enzymes in vitro (see section 5.2), but no formal clinical interaction studies have been performed.
Maltese: Ma jidhirx li zoledronic acid jeħel b'xi mod apprezzabbli mal-proteini fil-plażma u mhuwiex impeditur tal-enzima umana P450 in vitro (ara sezzjoni 5.2), iżda ma twettaq l-ebda studju kliniku formali ta' interazzjoni.
English: Baseline creatinine clearance (ml/min)
Maltese: Tneħħija talkreatinina bażilari (ml/min)
English: NR NR 424
Maltese: MM MM 424
English: *Doses have been calculated assuming target AUC of 0.66 (mg•hr/l) (CLcr = 75 ml/min).
Maltese: * Id-dożi ġew ikkalkulati fuq mira tal-AUC ta' 0.66 (mg•hr/l) (CLcr = 75 ml/min).
English: Proportion of patients with SREs (%) p-value
Maltese: Proporzjon ta' pazjenti b'SREs (%) Valur-p
English: Multipack (4x1 bottle)
Maltese: Pakkett multiplu (4x1 flixkun)
English: Zometa 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: Mutagenicity and carcinogenic potential
Maltese: Potenzjal mutaġenetiku u karċinoġeniku
English: Multipack (5x1 bottle)
Maltese: Pakkett multiplu (5x1 flixkun)
English: Musculoskeletal pain
Maltese: Uġigħ muskoluskelettriku
English: Skeletal morbidity rate p-value
Maltese: Rata ta' morbożità skelettrika Valur-p
English: Reproduction toxicity
Maltese: Tossiċità fis-sistema riproduttiva
English: EU/1/01/176/001 1 vial and 1 ampoule EU/1/01/176/002 4 vials and 4 ampoules
Maltese: EU/1/01/176/001 kunjett 1 u ampulla 1 EU/1/01/176/002 4 kunjetti u 4 ampulli
English: Gastrointestinal disorders Common:
Maltese: Disturbi gastrointestinali Komuni:
English: The reconstituted solution is stable for 24 hours at 2°C - 8°C.
Maltese: Is-soluzzjoni rrikostitwita tibqa' stabbli għal 24 siegħa f'temperatura ta' bejn 2°C - 8°C.
English: Multi-packs containing 4 (4x 1) or 5 (5x 1) bottles.
Maltese: Pakketti multipli li fihom 4 (4x 1) jew 5 (5x 1) flixken.
English: Blurred vision, scleritis and orbital inflammation
Maltese: Vista mċajpra, skleritie u infjammazzjoni orbitali
English: Adjusted dose (mg zoledronic acid in 100 ml) *
Maltese: Doża aġġustata (mg ta' zoledronic acid f'100 ml) *
English: One ampoule of solvent 5 ml
Maltese: Ampulla waħda b'5 ml solvent
English: The rate of atrial fibrillation serious adverse events was 1.3% (51 out of 3,862) and 0.6% (22 out of 3,852) in patients receiving zoledronic acid 5 mg and placebo, respectively.
Maltese: Ir-rata ta' avvenimenti avversi serji ta' fibrillazzjoni tal-atrija kienet ta' 1.3% (51 minn 3,862) u 0.6% (22 minn 3,852) f'pazjenti li kienu qegħdin jingħataw 5 mg ta' zoledronic acid u plaċebo, rispettivament.
English: The adverse reactions ranked under headings of frequency, are presented in Table 7.
Maltese: Ir-reazzjonijiet avversi kklassifikati taħt it-titli ta' frekwenza, huma elenkati f'Tabella 7.
English: You will be given adequate calcium and vitamin D supplements.
Maltese: Inti se tingħata supplimenti adegwati ta' kalċju u vitamina D.
English: The following conventional classification is used: very common (1/10), common (1/100 to <1/10), uncommon (1/1,000 to <1/100), rare (1/10,000 to <1/1,000), very rare (<1/10,000), not known (cannot be estimated from the available data).
Maltese: Ġiet użata l-klassifika konvenzjonali li ġejja: komuni ħafna (1/10), komuni (1/100 sa <1/10), mhux komuni (1/1,000 sa <1/100), rari (1/10,000 sa <1/1,000), rari ħafna (<1/10,000), mhux magħruf (ma tistax tittieħed stima mid-dejta disponibbli).
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 kontra 12% 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) kontra 41% (31/76).
English: - Concomitant therapies: chemotherapy, angiogenesis inhibitors (see section 4.5), radiotherapy to neck and head, corticosteroids.
Maltese: - It-terapiji konkomitanti: kimoterapija, inibituri tal-anġjoġenesi (ara sezzjoni 4.5), radjoterapija għar-ras u għall-għonq, kortikosterojdi.
English: Statistically significant differences are marked (*p<0.05) for between treatment comparisons (4 mg zoledronic acid vs. placebo)
Maltese: Differenzi statistikament sinifikanti huma mmarkati (*p<0.05) għat-tqabbil bejn kura u oħra (4 mg zoledronic acid kontra plaċebo)
English: Musculoskeletal and connective tissue disorders Common:
Maltese: Disturbi muskoluskelettriċi u tat-tessuti konnettivi Komuni:
English: Zometa has been associated with reports of renal dysfunction.
Maltese: Zometa ġieli ġie assoċjat ma' rapporti ta' disfunzjoni renali.
English: Convulsions, hypoaesthesia and tetany (secondary to hypocalcaemia)
Maltese: Konvulżjonijiet, ipoestesija u tetanja (kawża ta' ipokalċimija)
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 mittabib tiegħek permezz ta' ċerti testijiet tal-awrina).
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: 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 label b'74 u 76 pazjent f'kull grupp ta' kura, rispettivament.
English: The plasma protein binding is low, with the unbound fraction ranging from 60% at 2 ng/ml to 77% at 2000 ng/ml of zoledronic acid.
Maltese: L-irbit mal-proteini fil-plażma huwa baxx, bi proporzjon mhux marbut li jvarja minn 60% f'2 ng/ml sa 77% f'2000 ng/ml ta' zoledronic acid.
English: 1 bottle
Maltese: 1 flixkun
English: Multi-packs containing 10 (10 packs of 1) vials.
Maltese: Pakketti multipli li fihom 10 (10 pakketti ta' 1) kunjetti.
English: One ampoule of solvent 5 ml Four vials 4 mg Four ampoules of solvent 5 ml
Maltese: Kunjett wieħed ta' 4 mg Ampulla waħda b'5 ml solvent Erba' kunjetti ta' 4 mg Erba' ampulli b'5 ml solvent
English: Fractures*
Maltese: Ksur*
English: Nervous system disorders Common:
Maltese: Disturbi fis-sistema nervuża Komuni:
English: Table 2
Maltese: Tabella 5
English: Osteonecrosis of other anatomical sites
Maltese: Osteonekrożi ta' siti anatomiċi oħra
English: There were no statistically significant differences between the two zoledronic acid doses.
Maltese: Ma kienx hemm differenzi statistikament rilevanti bejn iż-żewġ dożi ta' zoledronic acid.
English: The adverse reactions ranked under headings of frequency, are presented in Table 6.
Maltese: Ir-reazzjonijiet avversi kklassifikati taħt it-titli ta' frekwenza, huma elenkati f'Tabella 6.
English: Table 7 Adverse reactions observed in paediatric patients with severe osteogenesis imperfecta
Maltese: Tabella 7 Reazzjonijiet avversi osservati f'pazjenti pedjatriċi b'osteoġenesi imperfetta severa
English: The SRE rate (events/person year) was 0.628 for zoledronic acid and 1.096 for placebo.
Maltese: Ir-rata ta' SRE (każijiet/sena persuna) kienet ta' 0.628 għal zoledronic acid u ta' 1.096 għall-plaċebo.
English: Placebo zoledronic acid 4 mg
Maltese: Plaċebo zoledronic acid 4 mg
English: Table 6 Adverse reactions observed in paediatric patients with severe osteogenesis imperfecta
Maltese: Tabella 6 Reazzjonijiet avversi osservati f'pazjenti pedjatriċi b'osteoġenesi imperfetta severa
English: Osteonecrosis of the external auditory canal (bisphosphonate class adverse reaction) and other anatomical sites including femur and hip
Maltese: Osteonekrożi tal-kanal estern tas-smigħ (reazzjoni avversa għall-klassi bifosfonati) u ta' siti anatomiċi oħra inklużi l-wirk u lġenbejn
English: Hypocalcaemia is an important identified risk with Zometa in the approved indications.
Maltese: L-ipokalċimija hija riskju identifikat importanti b'Zometa fl-indikazzjonijiet approvati.
English: Zometa is supplied as unit packs containing 1 or 4 vials and 1 or 4 ampoules, respectively, and as multi-packs containing 10 (10x 1+1) vials and ampoules.
Maltese: Zometa jiġi f'pakketti individwali ta' 1 jew 4 kunjetti u 1 jew 4 ampulli, rispettivament, u bħala pakketti multipli li fihom 10 (10x 1+1) kunjetti u ampulli.
English: Multi-packs containing 10 (10 packs of 1+1) vials and ampoules of water for injections.
Maltese: Pakketti multipli li fihom 10 (10 pakketti ta' 1+1) kunjetti u ampulli b'ilma għall-injezzjoni.
English: Bradycardia, cardiac arrhythmia (secondary to hypocalcaemia)
Maltese: Bradikardija, arritmija tal-qalb (kawża ta' ipokalċimija)
English: p-value
Maltese: Valur-p
English: The other ingredients are mannitol, sodium citrate.
Maltese: Fih ukoll mannitol u sodium citrate.
English: In clinical studies, Zometa has been administered concomitantly with commonly used anticancer agents, diuretics, antibiotics and analgesics without clinically apparent interactions occurring.
Maltese: Fi studji kliniċi, Zometa 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: Flu-like symptoms including arthritis and joint swelling.
Maltese: Sintomi jixbħu lill-influwenza inkluż artrite u nefħa fil-ġogi.
English: Diarrhoea, constipation, abdominal pain, dyspepsia, stomatitis, dry mouth
Maltese: Dijarea, stitikezza, uġigħ addominali, dispepsja, stomatite, ħalq xott
English: Hypophosphataemia 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 Zometa (see section 4.8)
Maltese: Ipofosfatimija Reazzjonijiet avversi li seħħew bi frekwenzi <5% kienu stmati b'mod mediku u ntwera li dawn ilkażijiet kienu konsistenti mal-profil ta' sigurtà stabbilit tajjeb ta' Zometa (ara sezzjoni 4.8).
English: Asthenia, peripheral oedema, injection site reactions (including pain, irritation, swelling, induration), chest pain, weight increase, anaphylactic reaction/shock, urticaria
Maltese: Astenja, edima periferali, reazzjoni fis-sit talinjezzjoni (inklużi uġigħ, irritazzjoni, nefħa, ebusija), uġigħ fis-sider, u żieda fil-piż, reazzjoni anafilattika/xokk anafilattiku, urtikarja
English: In one 3-year, randomised, double-blind controlled trial that evaluated the efficacy and safety of zoledronic acid 5 mg once yearly vs. placebo in the treatment of postmenopausal osteoporosis (PMO), the overall incidence of atrial fibrillation was 2.5% (96 out of 3,862) and 1.9% (75 out of 3,852) in patients receiving zoledronic acid 5 mg and placebo, respectively.
Maltese: Fi prova waħda kkontrollata, double-blind u magħmula b'mod każwali fuq 3 snin li evalwat l-effikaċja u s-sigurtà ta' 5 mg ta' aċidu żoledroniku darba fis-sena mqabbel ma' plaċebo fil-kura tal-osteoporożi ta' wara l-menopawża (PMO), l-inċidenza globali ta' fibrillazzjoni tal-atrija kienet ta' 2.5% (96 minn 3,862) u 1.9% (75 minn 3,852) f'pazjenti li kienu qegħdin jingħataw 5 mg ta' zoledronic acid u plaċebo, rispettivament.
English: Day 7
Maltese: 7 Ġurnata
English: Renal function impairment
Maltese: Indeboliment tal-funzjoni renali
English: One ml concentrate contains 0.8 mg zoledronic acid (as monohydrate).
Maltese: Millilitru 1 tal-konċentrat fih 0.8 mg zoledronic acid (bħala monohdyrate).
English: In an in vitro study, zoledronic acid showed low affinity for the cellular components of human blood, with a mean blood to plasma concentration ratio of 0.59 in a concentration range of 30 ng/ml to 5000 ng/ml.
Maltese: Fi studju in vitro, zoledronic acid wera affinità baxxa għall-komponenti ċellulari tad-demm uman, bi proporzjon ta' konċentrazzjoni medja ta' demm għal plażma ta' 0.59 f'firxa ta' konċentrazzjonijiet ta' 30 ng/ml sa 5000 ng/ml.
English: During post-marketing experience the following reactions have been reported (frequency rare): Atypical subtrochanteric and diaphyseal femoral fractures (bisphopsphonate 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 talbisfosfonat).