FrancophonIA/ELRC3.0 huggingface dataset:
English: MARKETING AUTHORISATION NUMBER(S) EU/2/98/010/021 (1 kg)
Maltese: Numru/i tal-awtorizzazzjoni għat-tqegħid fis-suq EU/2/98/010/017(1 kg)
English: Application in feed (premix)
Maltese: INDIKAZZJONI(JIET)
English: Name of the veterinary medicinal product Econor 10% premix for medicated feed for pigs and rabbits Valnemulin hydrochloride
Maltese: Econor 10% taħlita għal għalf medikat għal majjali u fniek Valnemulin hydrochloride
English: Valnemulin1 Valnemulin Porcine, rabbit
Maltese: GĦALL-ĦRUĠ TAL-LOTT, JEKK
English: Mixing instructions: mg Econor 50% premix/kg feed = Dosage required (mg/kg) x 2 x bodyweight (kg)/Daily feed intake (kg)
Maltese: Kalkolazzjoni tad-doża ta' kuljum: Ammont ta' Econor 10% trab orali (mg) meħtieġ = Doża meħtieġa (mg/kg) x piż tal-ġisem tal-majjali
English: Valnemulin is well-accepted in feed, but administered at concentrations above 200 mg valnemulin / kg feed may result in transient reduction in food consumption associated with unpalatability during the first few days of feeding.
Maltese: Valnemulin huwa aċċettat sew fl-għalf, iżda l-amministrazzjoni tiegħu f'konċentrazzjonijiet ikbar minn 200 mg valnemulin/kg ta' għalf, tista' tirriżulta fi tnaqqis temporanju fil-konsum tal ikel, assoċjat ma' nuqqas ta' palatabilità matul l-ewwel jiem ta' tmigħ.
English: 21 days
Maltese: 2 snin.
English: Dosage guidance table
Maltese: Tabella tal-gwida tad-dożaġġ
English: Rabbits may still show clinical signs of epizootic rabbit enteropathy (ERE) even when treated with the product; however, mortality in affected rabbits is reduced by administering the product.
Maltese: Għall-fniek huwa indikat sabiex inaqqas il-mortalità matul tifqigħa ta' Enteropatija Epiżootika talFniek (ERE) meta l-marda tkun ġiet dijanjostikata fil-merħla.
English: The European Commission granted a marketing authorisation valid throughout the European Union, for ProMeris on 19.12.2006.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq madwar l-Unjoni Ewropa, għal ProMeris fid: 19.12.2006.
English: Cats from various breeds (mainly European shorthair), age groups and weight that were infested with fleas were either treated with ProMeris or with other products authorised in the EU for this indication.
Maltese: Qtates minn diversi razez (primarjament ix-shorthair Ewropej), gruppi ta' età u piż li kienu infestati mill-briegħed jew ġew ittratti b'ProMeris jew bi prodotti oħra awtorizzati fl-UE għal din l-indikazzjoni.
English: ProMeris is a clear yellow to amber solution that contains metaflumizone as active substance.
Maltese: ProMeris huwa soluzzjoni trasparenti ta' lewn isfar jagħti fl-ambra li fih is-sustanza attiva metaflumizone.
English: Other information about ProMeris:
Maltese: Aktar tagħrif dwar ProMeris:
English: The active substance of ProMeris, metaflumizone, interferes with the neural activity of the fleas and consequently leads to the death of these parasites.
Maltese: Is-sustanza attiva f'ProMeris, metaflumizone tinterferixxi mal-attività tan-nervituri tal-briegħed u konsegwentement twassal għall-mewt ta' dawn il-parassiti.
English: What is the risk associated with ProMeris?
Maltese: X'inhu r-riskju assoċjat ma' ProMeris?
English: ProMeris is an “ectoparasiticide”, this means that it will kill parasites that live on the skin or in the fur of animals, such as fleas and ticks.
Maltese: ProMeris huwa “ektoparasitiċid” (ectoparasiticide), dan ifisser li dan joqtol parassiti li jgħixu fuq ilġilda jew fil-pil tal-annimali, bħalma huma briegħed jew qurdien.
English: Why has ProMeris been approved?
Maltese: Għaliex ġie approvat ProMeris?
English: What is ProMeris?
Maltese: X'inhu ProMeris?
English: The field trial was conducted in cats at 24 veterinary practices of different geographic regions in Germany and France.
Maltese: Il-prova fuq il-post saret fuq qtates f'24 kliniċi veterinarji ta' reġjuni ġeografiċi differenti filĠermanja u fi Franza.
English: The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of ProMeris exceed the risks for the treatment and prevention of flea infestations in cats.
Maltese: Il-Kumitat għall-Prodotti Mediċinali għall-Użu Veterinarju (CVMP) ikkonkluda li l-benefiċċji ta' ProMeris huma akbar mir-riskji għat-trattament u l-prevenzjoni ta' infestazzjonijiet tal-briegħed filqtates.
English: It is given to cats with a pre-filled spot-on pipette, a small plastic container which is already filled with the correct amount of ProMeris needed to treat one cat (ProMeris is available in 2 different sizes for various cat weights).
Maltese: Dan jingħata lill-qtates b'pipetta mimlija minn qabel għal użu lokalizzat (spot-on), kontenitur żgħir tal-plastik li huwa diġa' mimli b'ammont korrett ta' ProMeris meħtieġ għat-trattament ta' qattus wieħed (ProMeris huwa disponibbli f'żewġ daqsijiet differenti għal piżijiet differenti ta' qtates.
English: The effectiveness of metaflumizone against flea infestations in cats was investigated in laboratory studies and in a field trial.
Maltese: L-effikaċja ta' metaflumizone kontra infestazzjonijiet tal-briegħed fil-qtates ġiet analizzata fi studji tal-laboratorji u fi prova fuq il-post.
English: Once applied, it remains active for up to 6 weeks.
Maltese: Ladarba jiġi applikat jibqa attiv sa 6 ġimgħat.
English: The medicine killed fleas within 24 hours after treatment and its effectiveness lasted 6 weeks.
Maltese: Il-mediċina qatlet briegħed fi żmien 24 siegħa wara ttrattament u l-effikaċja tiegħu damet 6 ġimgħat.
English: The results of the field trial showed that ProMeris is effective in the treatment and prevention of flea infestations in cats.
Maltese: Ir-riżultati tal-prova fuq il-post urew li ProMeris huwa effikaċi fit-trattament u fil-prevenzjoni ta' infestazzjonijiet tal-briegħed fil-qtates.
English: There may be a change in appearance of the fur (oily appearance and clumping or spiking of hair) at the application site.
Maltese: Jista' jkun hemm tibdil fl-apparenza tal-pil (apparenza żejtnija jew tagħqid tax-xagħar jew jitla xwiek) fil-post tal-applikazzjoni.
English: It can also be used as part of a treatment strategy for the control of Flea Allergy Dermatitis, an allergic reaction of cats to flea bites.
Maltese: Jista' jintuża wkoll bħala parti minn strateġija ta' trattament għall-kontroll ta' dermatite allerġija talbriegħed, reazzjoni allerġika fil-qtates għall-qris mill-briegħed.
English: ProMeris is used to treat and to prevent flea infestations in cats.
Maltese: ProMeris jintuża fit-trattament u fil-prevenzjoni ta' infestazzjonijiet tal-briegħed fil-qtates.
English: As a precautionary measure, direct contact with the treated cat should be avoided and children should not be allowed to play with a treated animal until the application site is dry.
Maltese: Bħala miżura ta' prekawzjoni, kuntatt dirett mal-qattus ittrattat għandu jiġi evitat u t-tfal ma għandhomx jitħallew jilagħbu ma' annimal ittrattat sakemm il-post tal-applikazzjoni jkun niexef.
English: Data were provided on the pharmaceutical quality, the safety of the product in cats and the safety in humans (people in contact with the product) and the environment.
Maltese: Ingħatat informazzjoni dwar il-kwalità farmaċewtika, is-sigurtà tal-prodott fil-qtates u l-bnedmin (nies f'kuntatt mal-prodott) u s-sigurtà għall-ambjent.
English: How has ProMeris been studied?
Maltese: Kif ġie studjat ProMeris?
English: PHARMACEUTICAL PARTICULARS 6.1 List of excipients {As currently approved}.
Maltese: FARMAĊEWTIKU 6.1 Lista ta' sustanzi mhux attivi {Biex timtela mill-pajjiż partikolari}.
English: 6.2 Incompatibilities {As currently approved}.
Maltese: 6.2 Inkompatibilitajiet {Biex timtela mill-pajjiż partikolari}.
English: In an openlabel, 8-week study, Tanner Stage 1 (N=15) and Tanner Stage ≥2 (N=24) paediatric patients (ages 6-17 years) with heterozygous familial hypercholesterolemia and baseline LDL-C ≥4 mmol/L were treated with 5 or 10 mg of chewable or 10 or 20 mg of film-coated atorvastatin tablets once daily, respectively.
Maltese: Fi studju open-label ta' 8 ġimgħat, pazjenti pedjatriċi Tanner Stage 1 (N=15) u Tanner Stage ≥2 (N=24) (etajiet minn 6-17-il sena) b'iperkolesterolemija eterożigota familjali u LDL-C fil-linja bażi ta' ≥4 mmol/L ġew ikkurati b'5 jew 10 mg ta' pilloli atorvastatin li tomgħodhom jew 10 jew 20 mg ta' pilloli atorvastatin miksijin b'rita darba kuljum, rispettivament.
English: The mean achieved LDL-C value was 3.38 mmol/l (range: 1.81-6.26 mmol/l) in the atorvastatin group compared to 5.91 mmol/l (range: 3.93-9.96 mmol/l) in the placebo group during the 26-week double-blind phase.
Maltese: Il-valur medju miksub ta' LDL-C kien 3.38 mmol/l (medda: 1.81-6.26 mmol/l) fil grupp ta' atorvastatin meta mqabbel ma' 5.91 mmol/l (medda: 3.93-9.96 mmol/l) fil-grupp talplaċebo matul il-fażi double-blind ta' 26 ġimgħa.
English: {PRODUCT NAME} is indicated as an adjunct to diet for reduction of elevated total cholesterol, LDL-cholesterol, apolipoprotein B, and triglycerides in patients adults, adolescents and children aged 10 years or older with primary hypercholesterolaemia including familial hypercholesterolaemia (heterozygous variant) or combined (mixed) hyperlipidaemia (Corresponding to Types IIa and IIb of the Fredrickson classification) when response to diet and other nonpharmacological measures is inadequate.
Maltese: TAL-PRODOTT} huwa indikat bħala żieda mad-dieta għat-tnaqqis tal-kolesterol totali għoli, il-kolesterol LDL, l-apolipoproteina B, u t-trigliċeridi f'pazjenti adulti, adoloxxenti u tfal ta' 10 snin jew aktar b'iperkolesterolemija primarja fosthom iperkolesterolemija familjali (varjant eterożigota) jew iperlipidemija kombinata (imħallta) (li jikkorrispondu għat-Tipi IIa u IIb tal-klassifikazzjoni ta' Fredrickson) meta r-rispons għad-dieta u miżuri oħra mhux farmakoloġiċi ma jkunx adegwat.
English: 4.9 Overdose {As currently approved}.
Maltese: .9 Doża eċċessiva {Biex timtela mill-pajjiż partikolari}.
English: 4.8 Undesirable effects {As currently approved}.
Maltese: .8 Effetti mhux mixtieqa {Biex timtela mill-pajjiż partikolari}.
English: POSSIBLE SIDE EFFECTS {As currently approved}.
Maltese: TAL-PRODOTT} Effetti sekondarji li jista' jkollu
English: Mean values for LDL-C, TC, VLDL-C, and Apo B decreased by Week 2 among all subjects.
Maltese: Il-valuri medji għal LDL-C, TC, VLDL-C, u Apo B sa Ġimgħa 2 kienu naqsu fost lindividwi kollha.
English: LDL-C, triglycerides, and apolipoprotein B during the 26 week double-blind phase.
Maltese: Atorvastatin naqqas b'mod sinifikanti llivelli ta' C-totali, trigliċeridi, u apolipoproteina B fil-plażma matul il-fażi double-blind ta' 26 ġimgħa.
English: {PRODUCT NAME} 80 mg film-coated tablets Atorvastatin calcium [See Annex I - To be completed nationally]
Maltese: TAL-PRODOTT} 80 mg pilloli miksijin b'rita Atorvastatin calcium [Ara Anness I - Biex timtela mill-pajjiż partikolari]
English: HOW TO STORE {PRODUCT NAME} {As currently approved}.
Maltese: Tqala u treddigħ {Biex timtela mill-pajjiż partikolari}.
English: ANNEX II AMENDMENTS TO THE SUMMARY OF PRODUCT CHARACTERISTICS AND PACKAGE LEAFLET
Maltese: ANNESS II EMENDI FIS-SOMMARJU TAL-KARATTERISTIĊI
English: {PRODUCT NAME} 20 mg film-coated tablets Atorvastatin calcium [See Annex I - To be completed nationally]
Maltese: TAL-PRODOTT} 20 mg pilloli miksijin b'rita Atorvastatin calcium [Ara Anness I - Biex timtela mill-pajjiż partikolari]
English: {PRODUCT NAME} 10 mg film-coated tablets Atorvastatin calcium [See Annex I - To be completed nationally]
Maltese: TAL-PRODOTT} 10 mg pilloli miksijin b'rita Atorvastatin calcium [Ara Anness I - Biex timtela mill-pajjiż partikolari]
English: {PRODUCT NAME} 40 mg film-coated tablets Atorvastatin calcium [See Annex I - To be completed nationally]
Maltese: TAL-PRODOTT} 40 mg pilloli miksijin b'rita Atorvastatin calcium [Ara Anness I - Biex timtela mill-pajjiż partikolari]
English: What {PRODUCT NAME} contains {As currently approved}.
Maltese: U KWANTITATTIVA {Biex timtela mill-pajjiż partikolari}.
English: Paediatric use
Maltese: FARMAKOLOĠIKU
English: 1.3∙108 to 9.0∙108 CFU*/dose.
Maltese: -1 Escherichia coli O8:K87 ħaj mhux patoġeniku 1.3∙108 għal 9.0∙108 CFU*/doża.
English: EU (MA) Number Invented name
Maltese: UE (MA) Numru Isem ivvintat
English: * colony forming units
Maltese: * unitajiet li jiffurmaw kolonji
English: Vial (glass) 50 doses 4 vials Zero days
Maltese: 50 doża 4 kunjetti Żero jiem
English: Target species
Maltese: Speċijiet fil-mira
English: Date of latest renewal: 28 April 2017.
Maltese: Data tal-aħħar tiġdid: 28 ta' April 2017
English: Risk reduction of suffering from multiple events** (%)
Maltese: Tnaqqis fir-riskju li wieħed ibati minn każijiet multipli** (%)
English: Pamidronate 90 mg (N=99) *p-values compared to pamidronate.
Maltese: Pamidronate 90 mg (N=99) *valuri p imqabbla ma' pamidronate
English: Thrombocytopenia, leukocytopenia Pancytopenia
Maltese: Tromboċitopenija, lewkoċitopenija Panċitopenija
English: Proportion of patients with SREs (%) p-value
Maltese: Proporzjon ta' pazjenti b'SREs (%) valur p
English: Skeletal morbidity rate p-value
Maltese: Rata ta' morbożità skeletrika valur p
English: Multipack: 4 x 1 vial of 5 ml Multipack: 10 x 1 vial of 5 ml
Maltese: Pakkett multiplu: 4 x 1 kunjett ta' 5 mL Pakkett multiplu: 10 x 1 kunjett ta' 5 mL
English: Zoledronic acid medac 4mg/100ml solution for infusion medac Gesellschaft für klinische Spezialpräparate mbH Theaterstr.
Maltese: Zoledronic acid medac 4mg/100ml soluzzjoni għall-infużjoni medac Gesellschaft für klinische Spezialpräparate mbH Theaterstr.
English: • Cancer, co-morbid conditions (e.g. anaemia, coagulopathies, infection), smoking.
Maltese: • Kanċer, kundizzjonijiet komorbidi (eż. anemija, koagulopatiji, infezzjoni), tipjip.
English: Multipack: 4 x 1 bottle of 100 ml Multipack: 10 x 1 bottle of 100 ml
Maltese: Pakkett multiplu: 4 x 1 flixkun ta' 100 mL Pakkett multiplu: 10 x 1 flixkun ta' 100 mL
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 03 August 2012.
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 3 ta' Awwissu 2012
English: *Doses have been calculated assuming target AUC of 0.66 (mg•hr/l) (CLcr=75 ml/min).
Maltese: *Id-dożi ġew ikkalkulati billi ġiet preżunta mira ta' AUC ta' 0.66 (mg•hr/l) (CLcr=75 ml/min).
English: 1.0 mg/dl or 88 µmol/l.
Maltese: żieda ta' 0.1 mg/dl jew 88 µmol/l.
English: Median time to normocalcaemia was 4 days.
Maltese: Iż-żmien medjan għal normokalċemija kien ta' 4 ijiem.
English: Placebo Zoledronic acid 4 mg
Maltese: Plaċebo Zoledronic acid 4 mg
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: Zoledronic acid ma juri l-ebda twaħħil apprezzabli mal-proteini fil-plażma u ma jinibixxix enzimi umani P450 in vitro (ara sezzjoni 5.2), iżda ma twettaq l-ebda studju kliniku formali ta' interazzjoni.
English: Pain in extremities, arthralgia, musculoskeletal pain
Maltese: Uġigħ fl-estremitajiet, artralġja, uġigħ muskoluskeletriku
English: • Concomitant therapies: chemotherapy, angiogenesis inhibitors (see section 4.5), radiotherapy to neck and head, corticosteroids.
Maltese: • Terapiji fl-istess ħin: kimoterapija, inibituri tal-anġjoġenesi (ara sezzjoni 4.5), radjoterapija fl għonq u fir-ras, kortikosterojdi.
English: Table 6: Adverse reactions observed in paediatric patients with severe osteogenesis imperfecta1 Nervous system disorders
Maltese: Tabella 6: Reazzjonijiet avversi osservati f'pazjenti pedjatriċi b'osteogenesi imperfetta severa1 Disturbi fis-sistema nervuża
English: It is given as a single 15-minute intravenous infusion in a separate infusion line.
Maltese: Tingħata bħala infużjoni waħda ġol-vini fuq medda ta' 15-il minuta f'linja separata tal-infużjoni.
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 mill-ġisem minn proċess trifażiku: l-għibien mgħaġġel bifażiku miċ-ċirkolazzjoni sistemika, b'half-lives ta' t½α 0.24 u t½β 1.87 sigħat, segwit minn fażi twila ta' eliminazzjoni twila b'half-life ta' eliminazzjoni terminali ta' t½γ 146 sigħat.
English: Overhydration should be avoided in patients at risk of cardiac failure.
Maltese: Għandha tiġi evitata idratazzjoni eċċessiva f'pazjenti f'riskju ta' insuffiċjenza kardijaka.
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: The plasma protein binding is low, with the unbound fraction ranging from 60% at 2 ng/ml to 77% at 2,000 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'2,000 ng/mL ta' zoledronic acid.
English: The solution must be allowed to reach 20°C to 23.5°C before administration.
Maltese: Is-soluzzjoni għandha titħalla tilħaq 20°C sa 23.5°C qabel ma tingħata.
English: Baseline creatinine clearance (ml/min)
Maltese: Tneħħija tal kreatinina fil-linja bażi (ml/min)
English: Zoledronic acid was evaluated in rats for potential adverse effects on fertility of the parental and F1 generation.
Maltese: Zoledronic acid ġie evalwat fil-firien għal effetti avversi potenzjali fuq il-fertilità tal-ġenituri u ta' ġenerazzjoni F1.
English: 4 x 5 ml vials
Maltese: 4 x 5 mL kunjetti
English: • Potency of the bisphosphonate (higher risk for highly potent compounds), route of administration (higher risk for parenteral administration) and cumulative dose of bisphosphonate.
Maltese: • Potenza tal-bisfosfonat (riskju ogħla għal komposti potenti ħafna), mnejn jingħata (riskju ogħla għal għoti parenterali) u doża kumulattiva ta' bisfosfonat.
English: Figure 1: Mean changes from baseline in BPI scores.
Maltese: Figura 1: Tibdil medju mil-linja bażi fil-punteġġi BPI.
English: The adverse reactions ranked under headings of frequency, are presented in Table 7.
Maltese: Ir-reazzjonijiet avversi kklasifikati taħt intestaturi ta' frekwenza, huma ppreżentati f'Tabella 7.
English: Gesellschaft für klinische
Maltese: KLINIKU
English: Muscle spasms, osteonecrosis of the jaw Osteonecrosis of the external auditory canal (bisphosphonate class adverse reaction) and other anatomical sites including femur and hip
Maltese: Spażmi fil-muskoli, osteonekrosi tax-xedaq Osteonekrożi tal-kanal estern tas-smigħ (reazzjoni avversa għall-klassi bifosfonati) u ta' siti anatomiċi oħra inklużi l-wirk u lġenbejn
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' każijiet avversi serji ta' fibrillazzjoni atrijali kienet ta' 1.3 % (51 minn 3,862) u 0.6 % (22 minn 3,852) f'pazjenti li kienu qed jirċievu zoledronic acid 5 mg u plaċebo, rispettivament.
English: Blurred vision, scleritis and orbital inflammation
Maltese: Vista mċajpra, sklerite u infjammazzjoni orbitali
English: The adverse reactions ranked under headings of frequency, are presented in Table 6.
Maltese: Ir-reazzjonijiet avversi kklasifikati taħt intestaturi ta' frekwenza, huma ppreżentati f'Tabella 6.
English: Adults and elderly people
Maltese: Persuni adulti u anzjani
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) għal paragun bejn kura u oħra (4 mg zoledronic acid kontra plaċebo)
English: Pyrexia, fatigue Acute phase reaction, pain
Maltese: Deni, għeja Reazzjoni ta' fażi akuta, uġigħ
English: Austria medac Gesellschaft für klinische Spezialpräparate mbH Theaterstr.
Maltese: L-Awstrija medac Gesellschaft für klinische Spezialpräparate mbH Theaterstr.
English: 1 x5ml vial.
Maltese: Kunjett 1 x 5 mL.
English: CLcr is calculated from serum creatinine using the Cockcroft-Gault formula.
Maltese: CLcr tiġi kkalkulata mill-kreatinina fis-serum billi tuża l-formula ta' Cockcroft-Gault.
English: Single and multiple 5- and 15-minute infusions of 2, 4, 8 and 16 mg zoledronic acid in 64 patients with bone metastases yielded the following pharmacokinetic data, which were found to be dose independent.
Maltese: Infużjonijiet waħidhom jew multipli ta' 2, 4, 8 u 16 mg ta' zoledronic acid li ngħataw fuq medda ta' 5 minuti u 15-il minuta f'64 pazjent b'metastasi tal-għadam, taw id-dejta farmakokinetika li ġejja, li nstab li kienet indipendenti mid-doża.
English: In the clinical programme patients aged 1 to < 3 years received 0.025 mg/kg zoledronic acid (up to a maximum single dose of 0.35 mg) every 3 months and patients aged 3 to 17 years received 0.05 mg/kg zoledronic acid (up to a maximum single dose of 0.83 mg) every 3 months.
Maltese: Fil-programm kliniku pazjenti li kellhom minn sena sa < 3 irċivew 0.025 mg/kg ta' zoledronic acid (sa doża waħda massima ta' 0.35 mg) kull 3 xhur, u pazjenti li kellhom minn 3 sa 17-il sena rċivew 0.05 mg/kg ta' zoledronic acid (sa doża waħda massima ta' 0.83 mg) kull 3 xhur.
English: Hypomagnesaemia, hypokalaemia Hyperkalaemia, hypernatraemia
Maltese: Ipomanjesemija, ipokalemija Iperkalemija, ipernatremija
English: Only limited pharmacokinetic data are available in patients with severe renal insufficiency (creatinine clearance < 30 ml/min).
Maltese: Hemm biss dejta farmakokinetika limitata disponibbli f'pazjenti b'indeboliment sever tal-kliewi (tneħħija tal-kreatinina ta' < 30 ml/min).
English: Zoledronic acid medac contains sodium
Maltese: Zoledronic acid medac fih is-sodium
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 (li kellhom minn sena sa 17-il sena) b'osteoġenesi imperfecta severa (tipi I, III u IV), ġew ipparagunati ma' pamidronate mogħti ġol-vina fi studju wieħed internazzjonali, multiċentriku, li fih il-parteċipanti ntgħażlu b'mod każwali, open label, b'74 u 76 pazjent f'kull grupp ta' kura, rispettivament.
English: - Flu-like symptoms including arthritis and joint swelling.
Maltese: − Sintomi jixbħu lill-influwenza inkluż artrite u nefħa fil-ġogi.
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 medac, pazjenti bi kreatinina fis-serum ta' > 265 µmol/l jew > 3.0 mg/dl ġew esklużi.
English: In clinical trials 69 patients who relapsed or were refractory to initial treatment (zoledronic acid 4 mg, 8 mg or pamidronate 90 mg) were retreated with 8 mg zoledronic acid.
Maltese: Fil-provi kliniċi, 69 pazjent li rkadew jew li kienu refrattarji għall-kura inizjali (zoledronic acid 4 mg, 8 mg jew pamidronate 90 mg), reġgħu ġew ikkurati b' 8 mg zoledronic acid.
English: The SRE rate (events/person year) was 0.628 for zoledronic acid and 1.096 for placebo.
Maltese: Ir-rata ta' SRE (każijiet kull persuna fis-sena) kienet ta' 0.628 għal zoledronic acid u 1.096 għallplaċebo.
English: Clinical experience with acute overdose of zoledronic acid is limited.
Maltese: L-esperjenza klinika b'doża eċċessiva akuta ta' zoledronic acid hi limitata.
English: Dyspnoea, cough, bronchoconstriction Interstitial lung disease
Maltese: Qtugħ ta' nifs, sogħla, restrizzjoni tal-bronki Mard tal-pulmun interstizjali