FrancophonIA/ELRC3.0 huggingface dataset:
English: It is also indicated for the treatment of renal disease in adult patients with hypertension and type 2 diabetes mellitus as part of an antihypertensive medicinal product regimen (see sections 4.3, 4.4, 4.5 and 5.1).
Maltese: Hu indikat ukoll għall-kura għall-mard renali f'pazjenti adulti li għandhom pressjoni għolja u dijabete mellitus ta' tip 2 bħala parti mill-kura kontra il-pressjoni għolja (ara sezzjonijiet 4.3, 4.4, 4.5 u 5.1).
English: Diabetes Mellitus (IRMA 2)” shows that irbesartan 300 mg delays progression to overt proteinuria in patients with microalbuminuria.
Maltese: Esperjenza f'adulti esposti għal dożi sa 900 mg/jum għal 8 ġimgħat ma uriet ebda tossiċità.
English: Hyperkalaemia: as with other medicinal products that affect the renin-angiotensin-aldosterone system, hyperkalaemia may occur during the treatment with Aprovel, especially in the presence of renal impairment, overt proteinuria due to diabetic renal disease, and/or heart failure.
Maltese: Iperkalimja: bħalma jiġri bi prodotti mediċinali oħra li jaffettwaw is-sistema ta' renin-angiotensinaldosterone, iperkalimja tista' sseħħ waqt il-kura b'Aprovel, speċjalment fil-preżenza t'indeboliment renali, proteinuria ovvja minħabba mard renali dovut għad-dijabete, u/jew insuffiċjenza tal-qalb.
English: NAME OF THE MEDICINAL PRODUCT Aprovel 75 mg tablets.
Maltese: Aprovel 75 mg pilloli.
English: thrombocytopenia Immune system disorders Not known:
Maltese: tromboċitopenija Disturbi tas-sistema immuni
English: What Aprovel looks like and contents of the pack Aprovel 150 mg tablets are white to off-white, biconvex, and oval-shaped with a heart debossed on one side and the number 2772 engraved on the other side.
Maltese: Il-pilloli Aprovel 150 mg huma bojod għal offwajt, ibbuzzati fuq iż-żewġ naħat, ovali, b'qalb stampata fuq naħa waħda u n-numru 2772 imnaqqax fuq in-naħa l-oħra.
English: Hypertension
Maltese: iperkalemija
English: NAME OF THE MEDICINAL PRODUCT Aprovel 75 mg tablets irbesartan NAME OF THE MARKETING AUTHORISATION HOLDER sanofi-aventis groupe EXPIRY DATE
Maltese: Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq: sanofi-aventis groupe
English: A lower starting dose (75 mg) should be considered for patients undergoing haemodialysis (see section 4.4).
Maltese: Wieħed għandu jikkonsidra doża inqas fil-bidu (75 mg) f'pazjenti li qed jagħmlu l-emodijalisi (ara sezzjoni 4.4).
English: These adverse reactions are derived from spontaneous reports.
Maltese: Dawn ir-reazzjonijiet avversi huma derivati minn rapporti spontanji.
English: Over a subsequent two week period where patients were re-randomized to either active medicinal product or placebo, patients on placebo had increases of 2.4 and 2.0 mmHg in SeSBP and SeDBP compared to +0.1 and -0.3 mmHg changes respectively in those on all doses of irbesartan (see section 4.2).
Maltese: Fuq il-perjodu tal-ġimagħtejn ta' wara fejn ilpazjenti ġew re-randomised jew għal prodott mediċinali attiv jew għal plaċebo, il-pazjenti fuq plaċebo kellhom żidiet ta' 2.4 u 2.0 mmHg fis-SeSBP u SeDBP meta mqabbla ma' bidliet rispettivi ta' +0.1 u0.3 mmHg f'dawk fuq id-dożi kollha ta' irbesartan (ara sezzjoni 4.2).
English: What Aprovel looks like and contents of the pack Aprovel 75 mg film-coated tablets are white to off-white, biconvex, and oval-shaped with a heart debossed on one side and the number 2871 engraved on the other side.
Maltese: Il-pilloli Aprovel 75 mg huma bojod għal offwajt, ibbuzzati fuq iż-żewġ naħat, ovali, b'qalb stampata fuq naħa waħda u n-numru 2871 imnaqqax fuq in-naħa l-oħra.
English: As with similar medicines, rare cases of allergic skin reactions (rash, urticaria), as well as localised swelling of the face, lips and/or tongue have been reported in patients taking irbesartan.
Maltese: Bħal b'mediċini simili, każijiet rari ta' reazzjonijiet allerġiċi għall-ġilda (raxx, utrikarja), kif ukoll nefħa lokalizzata tal-wiċċ, xofftejn u/jew ilsien ġew irrapportati f'pazjenti li jieħdu irbesartan.
English: NAME OF THE MEDICINAL PRODUCT Aprovel 75 mg tablets irbesartan STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains: irbesartan 75 mg LIST OF EXCIPIENTS Excipients: also contains lactose monohydrate.
Maltese: Aprovel 75 mg pilloli irbesartan DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA(I)
English: See also information under the heading “Do not take Aprovel”.
Maltese: Ara wkoll l-informazzjoni taħt l-intestatura “Tiħux Aprovel”
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS NAME OF THE MEDICINAL PRODUCT Aprovel 300 mg tablets irbesartan NAME OF THE MARKETING AUTHORISATION HOLDER sanofi-aventis groupe EXPIRY DATE
Maltese: Bħal fil-każi ta' prodotti mediċinali oħra li jaffettwaw is-sistema renin-angiotensin, pazjenti suwed bi pressjoni għolja wrew ferm inqas respons għal monoterapija b'irbesartan.
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 tal-Aġenzija Ewropeja dwar il-Mediċini http://www.ema.europa.eu/
English: Results showed that Cmax, AUC and clearance rates were comparable to those observed in adult patients receiving 150 mg irbesartan daily.
Maltese: Ir-riżultati wrew li Cmax, AUC u r-rati ta' tneħħija setgħu jitqabblu ma' dawk osservati f'pazjenti adulti li jieħdu 150 mg irbesartan kuljum.
English: Investigations
Maltese: MANIFATTURI
English: Exposure to AIIRA therapy during the second and third trimesters is known to induce human foetotoxicity (decreased renal function, oligohydramnios, skull ossification retardation) and neonatal toxicity (renal failure, hypotension, hyperkalaemia).
Maltese: Espożizzjoni għal terapija AIIRA matul it-tieni u t-tielet trimestri hija magħrufa li twassal għal tossiċità tal-fetu uman (tnaqqis fil-funzjoni tal-kliewi, oligohydramnios, tnaqqis fl-ossifikazzjoni talgħadam tar-ras) u tossiċità neonatali (nuqqas fil-funzjoni tal-kliewi, pressjoni baxxa, iperkalemija) (Ara sezzjoni 5.3).
English: Cartons of 30 film-coated tablets in PVC/PVDC/Aluminium blisters.
Maltese: Pakketti ta' 30 pillola miksija b'rita f'folji tal-PVC/PVDC/Aluminju.
English: Very common: Hyperkalaemia* occurred more often in diabetic patients treated with irbesartan than with placebo.
Maltese: Iperkalimja* ġrat iktar frekwenti f'pazjenti dijabetiċi ikkurati b'irbesartan milli bil-plaċebo.
English: There is no clinical experience in patients with severe hepatic impairment.
Maltese: Għad m'hemmx esperjenza klinika f'pazjenti b'indeboliment epatiku sever.
English: EXP
Maltese: Is-Sibt
English: EU/1/97/046/026-030 EU/1/97/046/033 EU/1/97/046/036 EU/1/97/046/039
Maltese: EU/1/97/046/033 EU/1/97/046/036
English: Cartons of 90 film-coated tablets in PVC/PVDC/Aluminium blisters.
Maltese: Pakketti ta' 90 pillola miksija b'rita f'folji tal-PVC/PVDC/Aluminju.
English: NAME OF THE MEDICINAL PRODUCT Aprovel 300 mg tablets.
Maltese: Aprovel 300 mg pilloli.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 300 mg of irbesartan.
Maltese: Kull pillola miksija b'rita fiha 300 mg irbesartan.
English: NAME OF THE MEDICINAL PRODUCT Aprovel 150 mg tablets irbesartan STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains: irbesartan 150 mg LIST OF EXCIPIENTS Excipients: also contains lactose monohydrate.
Maltese: Aprovel 150 mg pilloli irbesartan DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA(I)
English: Renal impairment and kidney transplantation: when Aprovel is used in patients with impaired renal function, a periodic monitoring of potassium and creatinine serum levels is recommended.
Maltese: Indeboliment renali u trapjant tal-kliewi: meta Aprovel jintuża f'pazjenti b'indeboliment renali, hija irrikmandata osservanza perjodika tal-livelli tal-potassju u tal-krejatinina fis-serum.
English: The most likely manifestations of overdose are expected to be hypotension and tachycardia; bradycardia might also occur from overdose.
Maltese: L-iktar manifestazzjonijiet probabbli ta' doża eċċessiva huma mistennija li jkunu pressjoni baxxa, u takikardija; bradikardija tista' wkoll tiġi ikkaġunata minn doża eċċessiva.
English: Valsartan
Maltese: suffejra
English: In hypertensive type 2 diabetic patients, therapy should be initiated at 150 mg irbesartan once daily and titrated up to 300 mg once daily as the preferred maintenance dose for treatment of renal disease.
Maltese: F'pazjenti li għandhom dijabete ta' tip 2 u jbatu minn pressjoni għolja, il-kura mogħtija fil-bidu hija ta' 150 mg ta' irbesartan darba kuljum u tiġi titrata għal 300 mg darba kuljum bħala l-aħjar doża ta' manteniment ippreferuta għall-kura tal-mard renali.
English: Aliskiren-containing products or ACE-inhibitors: clinical trial data has shown that dual blockade of the renin-angiotensin-aldosterone system (RAAS) through the combined use of ACE-inhibitors,
Maltese: Imblokk doppju tas-sistema tar-renin-angiotensin-aldosterone (RAAS - renin-angiotensin-aldosterone system): hemm evidenza li l-użu fl-istess ħin ta' inibituri ta' ACE, imblokkaturi tar-riċetturi ta'
English: Potassium supplements and potassium-sparing diuretics: based on experience with the use of other medicinal products that affect the renin-angiotensin system, concomitant use of potassium-sparing diuretics, potassium supplements, salt substitutes containing potassium or other medicinal products that may increase serum potassium levels (e.g. heparin) may lead to increases in serum potassium and is, therefore, not recommended (see section 4.4).
Maltese: Supplimenti tal-potassium u dijuretiċi potassium-sparing: ibbażat fuq l-esperjenza bl-użu ta' prodotti mediċinali oħra li jaffettwaw lis-sistema ta' renin-angiotensin, l-użu konkomitanti ta' dijuretiċi potassium-sparing, supplimenti tal-potassium, sostituti tal-melħ li fihom il-potassium jew prodotti mediċinali oħra li jżidu il-livelli tal-potassium fis-serum (eż. ħeparina) jistgħu jwasslu għal żidiet talpotassium fis-serum u, għalhekk, mhumiex irrikmandati (ara sezzjoni 4.4).
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS NAME OF THE MEDICINAL PRODUCT Aprovel 75 mg tablets irbesartan NAME OF THE MARKETING AUTHORISATION HOLDER sanofi-aventis groupe EXPIRY DATE
Maltese: Madankollu, doża ta' 75 mg fil-bidu tal-kura tista' tiġi kkonsidrata, speċjalment f'pazjenti fuq emodijalisi u anzjani ‘il fuq minn 75 sena.
English: There is no clinically important effect on serum uric acid or urinary uric acid secretion.
Maltese: M'hemmx effett ta' importanza klinika fil-livelli tal-uric acid fis-serum jew fil-ħruġ tal-uric acid 'malawrina.
English: The slowing in the progression to clinical proteinuria was evident as early as three months and continued over the 2 year period.
Maltese: Id-dewmien fil-progressjoni għal proteinuria klinika kien evidenti kmieni sa minn tlett xhur u baqa' għal iktar minn perjodu ta' 2 snin.
English: The MAH must ensure that the manufacturing processes of the drug substances used for their drug products are reviewed for the potential risk of formation of Nnitrosamines and changed as necessary to minimise nitrosamine contamination as much as possible.
Maltese: Il-MAH għandu jiżgura li l-proċessi ta' manifattura tas-sustanzi mediċinali użati għall-prodotti mediċinali tagħhom jiġu riveduti għar-riskju potenzjali ta' formazzjoni ta' N-nitrosamini u mibdula kif meħtieġ biex titnaqqas kemm jista' jkun ilkontaminazzjoni tan-nitrosamina.
English: EU/1/97/046/016-020 EU/1/97/046/031 EU/1/97/046/034 EU/1/97/046/037
Maltese: EU/1/97/046/031 EU/1/97/046/034
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 75 mg of irbesartan.
Maltese: Kull pillola miksija b'rita fiha 75 mg irbesartan.
English: Suggested measures include induction of emesis and/or gastric lavage.
Maltese: Miżuri issuġġeriti jinkludu induzzjoni tar-rimettar u/ jew tal-ħasil gastriku.
English: NAME OF THE MEDICINAL PRODUCT Aprovel 300 mg tablets irbesartan NAME OF THE MARKETING AUTHORISATION HOLDER sanofi-aventis groupe EXPIRY DATE
Maltese: Iktar tard, id-doża tista' tiżdied għal 300 mg darba kuljum jiddependi fuq l-effett fuq il-pressjoni.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 150 mg of irbesartan.
Maltese: Kull pillola miksija b'rita fiha 150 mg irbesartan.
English: 4.3 Contraindications
Maltese: 4.3 Kontra-indikatazzjonijiet
English: − Urticaria.
Maltese: -Urtikarja.
English: Manufacturer Hospira UK Limited Horizon
Maltese: Manifattur Hospira UK Limited Horizon
English: Date of first authorization: 19 November 2012 Date of latest renewal: 24 August 2017
Maltese: Data tal-ewwel awtorizzazzjoni: 19 ta' Novembru 2012 Data tal-aħħar tiġdid: 24 ta' Awwissu 2017
English: Uveitis, episcleritis, iritis
Maltese: Uveite, episklerite, irite
English: Uncommon Vertigo
Maltese: Mhux komuni Vertigo
English: Adverse reactions in Table 1 are listed according to MedDRA system organ class and frequency category.
Maltese: Ir-reazzjonijiet avversi f'Tabella 1 huma mniżżla skont is-sistema MedDRA ta' klassifikazzjoni tal-organi u tal-kategorija ta' frekwenza.
English: After opening: 24 hours at 2°C - 8°C
Maltese: Wara li tinfetaħ: 24 siegħa f'temperatura ta' 2°C - 8°C
English: NA NA
Maltese: TAS-SAĦĦA
English: Pfizer SA/NV
Maltese: Pfizer SA/NV Tél/Tel:
English: Five of the 6 patients had SAP within the normal range at month 6 (Late Observation Carried Forward, LOCF).
Maltese: Ħamsa mis-6 pazjenti kellhom SAP fil-medda normali fis-6 xahar (L-Aħħar Osservazzjoni Rrappurtata, LOCF).
English: After 6 months, zoledronic acid showed 96% (169/176) and 89% (156/176) response and serum alkaline phosphatase (SAP) normalisation rates compared to 74% (127/171) and 58% (99/171) for risedronate (all p<0.001).
Maltese: Wara 6 xhur, zoledronic acid wera rati ta' rispons u ta' treġġigħ lura għan-normal tas-serum alkaline phosphatase (SAP) ta' 96% (169/176) u 89% (156/176) mqabbla ma' 74% (127/171) u 58% (99/171) għal risedronate (kollha kellhom p<0.
English: Skeletal morbidity rate p-value
Maltese: Rata ta' morbożità skeletrika Valur-p
English: Pfizer Pharma PFE GmbH Tel: + 49 (0)800 8535555
Maltese: PFE GmbH Tel: + 49 (0)800 8535555
English: The main molecular target of zoledronic acid in the osteoclast is the enzyme farnesyl pyrophosphate synthase.
Maltese: Il-mira molekulari l-aktar importanti ta' zoledronic acid fl-osteoklast hija l-enzima farnesyl pyrophosphate synthase.
English: Osteonecrosis of the jaw (see sections 4.4 and 4.8 Class effects)
Maltese: Osteonekrożi tax-xedaq (ara l-effetti skont il-klassi f'sezzjonijiet 4.4 u 4.8)
English: Frequency cannot be estimated from available data.
Maltese: Mhuwiex possibbli li ssir stima talfrekwenza mill-informazzjoni disponibbli. †
English: Incidence of individual adverse reactions following the first infusion was: fever (17.1%), myalgia (7.8%), flu-like symptoms (6.7%), arthralgia (4.8%) and headache (5.1%).
Maltese: L-inċidenza ta' reazzjonijiet avversi individwali wara l-ewwel infużjoni kienu: deni (17.1%), majalġja (7.8%), sintomi bħal tal-influwenza (6.7%), artralġja (4.8%) u uġigħ ta' ras (5.1%).
English: Zoledronic Acid Hospira 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 kienet preżunta mira ta' AUC ta' 0.66 (mg•hr/l) (CLcr = 75 ml/min).
English: CLcr is calculated from serum creatinine using the Cockcroft-Gault formula.
Maltese: CLcr tiġi kkalkulata mill-kreatinina fis-serum bil-formula CockcroftGault.
English: Convulsions, hypoaesthesia and tetany (secondary to hypocalcaemia)
Maltese: Konvulżjonijiet, ipoesteżija u tetanja (kawża ta' ipokalċimija)
English: Tabulated list of adverse reactions
Maltese: Lista ttabulata bir-reazzjonijiet avversi
English: Not known**
Maltese: Mhux magħruf**
English: - 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;
Maltese: - Għall-pazjenti b'linja bażi normali ta' kreatinina fis-serum (<1.4 mg/dl jew <124 µmol/l), żieda ta' 0.5 mg/dl jew 44 µmol/l;
English: Acquired Fanconi syndrome General disorders and administration site conditions Common:
Maltese: Sindrome Fanconi Akkwiżita Disturbi ġenerali u kondizzjonijiet ta' mnejn jingħata Komuni:
English: Pam 90 mg zoledronic acid
Maltese: Pam 90 mg zoledronic acid 4 mg
English: Uncommon Anaemia
Maltese: Mhux komuni Anemija
English: Zoledronic acid is eliminated by renal excretion.
Maltese: Zoledronic acid jiġi eliminat permezz tal-eliminazzjoni renali.
English: *Doses have been calculated assuming target AUC of 0.66 (mg•hr/l) (CLcr=75 ml/min).
Maltese: * Id-dożi nħadmu skont l-AUC mixtieq ta' 0.66(mg•hr/l) Cler = 75 ml/min).
English: - 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: Adjusted dose (mg zoledronic acid) *
Maltese: Doża aġġustata (mg zoledronic acid)*
English: Renal impairment.
Maltese: Indeboliment renali.
English: Baseline creatinine clearance (ml/min)
Maltese: Linja bażi ta' riferiment għattneħħija ta' kreatinina (ml/min)
English: Solution for infusion 4 mg/100 ml
Maltese: Soluzzjoni għall-infużjoni 4 mg/100 ml
English: Sodium citrate Sodium chloride Water for injections
Maltese: Sodium citrate Sodium chloride Ilma għall-injezzjonijiet
English: Zoledronic Acid Hospira contains the active substance zoledronic acid.
Maltese: Zoledronic Acid Hospira fih is-sustanza attiva zoledronic acid.
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 bi kreatinina fis-serum ta' >265 µmol/l jew >3.0 mg/dl kienu esklużi.
English: 55.6% (p=0.021)* 83.3% (p=0.010)* 86.7% (p=0.015)*
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 imqabbla ma' pamidronate
English: Uncommon Blood creatinine increased, pollakiuria, proteinuria
Maltese: Żieda fil-kreatinina tad-demm, pollakijurja, proteinurja
English: Zoledronic acid is not systemically metabolised and does not affect human cytochrome P450 enzymes in vitro (see section 5.2).
Maltese: Zoledronic acid ma jkunx immetabolizzat b'mod sistemiku u ma jeffettwax l-enzimi tal-bniedem cytochrome P450 in vitro (ara sezzjoni 5.2).
English: In the osteoporosis trials (PFT, HORIZON - Recurrent Fracture Trial [RFT]) the pooled atrial fibrillation incidences were comparable between zoledronic acid (2.6%) and placebo (2.1%).
Maltese: Fil-provi fuq l-osteoporożi (PFT, HORIZON - Prova dwar il-ksur Rikorrenti [RFT]) l-inċidenza tal-każijiet ta' fibrillazzjoni fl-atrija miġbura flimkien kienu komparabbli bejn zoledronic acid (2.6%) u l-plaċebo (2.1%).
English: Zoledronic acid is not highly bound to plasma proteins (approximately 43-55% bound) and interactions resulting from displacement of highly protein-bound medicinal products are therefore unlikely.
Maltese: Zoledronic acid ma jingħaqadx bil-qawwa mal-proteini tal-plażma (madwar 43-55% jingħaqad) u għaldaqstant interazzjonijiet li jirriżultaw minn spostament ta' prodotti mediċinali li jkunu marbutin mal-proteini mhux probabbli.
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), radjuterapija għar-ras u għall-għonq, kortikosterojdi.
English: Therefore, interactions resulting from displacement of highly protein-bound medicinal products are unlikely.
Maltese: Għaldaqstant, interazzjonijiet li jirriżultaw minn spostament ta' prodotti mediċinali li jintrabtu ħafna mal-proteini mhuwiex probabbli.
English: Adjusted dose (mg zoledronic acid)
Maltese: Doża aġġustata (mg zoledronic acid)
English: • Monitoring of serum creatinine should be considered in at-risk patients.
Maltese: • Għandu jiġi kkunsidrat monitoraġġ tal-kreatinina tas-serum f'pazjenti li jkunu f'riskju.
English: Zoledronic acid is contraindicated in patients with creatinine clearance < 35 ml/min (see sections 4.3 and 4.4).
Maltese: Zoledronic acid huwa kontraindikat f'pazjenti bi tneħħija ta' kreatinina < 35 ml/min (ara sezzjonijiet 4.3 u 4.4).
English: Uncommon Neck pain, musculoskeletal stiffness, joint swelling, muscle spasms, shoulder pain, musculoskeletal chest pain, musculoskeletal pain, joint stiffness, arthritis, muscular weakness
Maltese: Uġigħ fl-għonq, ebusija muskoluskeletrika, nefħa fil-ġogi, spażmi fil-muskoli, uġigħ fl-ispallejn, uġigħ muskoluskeletriku fis-sider, uġigħ muskoluskeletriku, ebusija fil-ġogi, artrite, dgħjufija tal-muskoli
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 1.096 għall-plaċebo.
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% (wirk) u 14% (tibja) ta' pazjenti li kellhom osteoġenesi imperfecta severa kkurati b'zoledronic acid vs 12% u 5% ta' pazjenti kkurati b'pamidronate, kienet x'kienet it-tip tal-marda u l-kawża tagħha iżda l-inċidenza globali ta' ksur kienet kumparabbli għall-pazjenti kkurati b'zoledronic acid u pamidronate: 43% (32/74) vs 41% (31/76).
English: Intravenously administered zoledronic acid is eliminated by a triphasic process: rapid biphasic disappearance from the systemic circulation, with half-lives of t½α 0.24 and t½β 1.87 hours, followed by a long elimination phase with a terminal elimination half-life of t½γ 146 hours.
Maltese: Zoledronic acid mogħti ġol-vina jiġi eliminat minn proċess ta' tliet fażijiet: l-għajbien mgħaġġel miċ-ċirkolazzjoni sistemika f'żewġ fażijiet, b'half-lives ta' t½ α 0.24 u t½ β 1.87 sigħat, segwit b'fażi twila ta' eliminazzjoni b'half-life terminali ta' eliminazzjoni ta' t½ γ 146 siegħa.