FrancophonIA/ELRC3.0 huggingface dataset:
English: The excipients listed in section 6.1 of the SPC are either allowed substances for which table 1 of the annex to Commission Regulation (EU) No 37/2010 indicates that no MRLs are required or considered as not falling within the scope of Regulation (EC) No 470/2009 when used as in this veterinary medicinal product.
Maltese: Is-sustanzi mhuz attivi msemijja f'sezzjoni 6.1 tal-KPQ huma jew sustanzi permessi liema tabella 1 tal-anness għar-Regoalment tal-Kummissjoni (KE) Nru 37/2010 tindika li m'hemmx bżonn MRLs jew huma kunsidrati li ma jaqgħux fl-iskop tar-Regolament (KE) Nru 470/2009 meta użati f'dan il-prodott mediċinali veterinarju.
English: Pharmacotherapeutic group: Anthelmintics, benzimidazole and related substances - fenbendazole.
Maltese: Antiħelmintik, benzimidazole u sustanzi relatati - fenbendazole Kodici ATC veterinarja:
English: In the absence of available data, treatment of chicken less than 3 weeks of age should be based on a benefit/risk assessment by the responsible veterinarian.
Maltese: Fin-nuqqas ta' informazzjoni, trattament ta' tiġieġ ta' anqas minn 3 ġimġħat ta' età, irid ikun ibbażat fuq valutazzjoni benefiċċju/riskju mill-veterinarju responasabbli..
English: Stir until content in the stock suspension container is visibly homogeneous.
Maltese: Ħawwad sakemm il-kontenut fil-kontenitur stock tal-medikazzjoni jkun viżibilment omoġenu.
English: Meat and offal: 6 days for 1 mg fenbendazole /kg dose;
Maltese: Laħam u ġewwieni: 6 ijiem għal doża ta`1mg fenbendazole/kg.
English: 1 l 4 l
Maltese: 1 litru 4 litri
English: 27460 Igoville
Maltese: Igoville Franza
English: SPECIAL STORAGE CONDITIONS Do not freeze.
Maltese: Klassifikazzjo ni terapewtika
English: ml product/day = Total estimated body weight (kg) of chicken to be treated x 0.01 ml
Maltese: ml prodott/ġurnata = Piż tal-ġisem total (kg) tat-tiġieġ li se jiġu trattati x 0.01 ml
English: ml product/day = Total estimated body weight (kg) of pigs to be treated x 0.0125 ml
Maltese: ml prodott/ġurnata = Piż tal-ġisem total (kg) tal-ħnieżer li se jiġu trattati x 0.0125 ml Eżempji:
English: Total body weight of chickens to be treated amount of product per day for 1 mg FBZ/ kg (ml/day)
Maltese: Ammont talprodott kull ġurnata għall-1mg FBZ/kg
English: Treatment of Ascaridia galli and Heterakis gallinarum: ml product/day = Total estimated body weight (kg) of chicken to be treated x 0.005 ml
Maltese: ml prodott/ġurnata = Piż tal-ġisem total (kg) tat-tiġieġ li se jiġu trattati x 0.005 ml
English: It acts by interfering with the energy metabolism of the nematode.
Maltese: Jaħdem billi jinterferixxi fil metaboliżmu tal-energija tan-nematod.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml contains:
Maltese: 1ml fih:
English: This veterinary medicinal product may be toxic to humans after ingestion.
Maltese: Il-prodott mediċinali veterinarju jista' jkun tossiku għall-bniedem jekk jiġi inġerit.
English: The dose is 2.5 mg fenbendazole per kg body weight per day (equivalent to 0.0125 ml Panacur AquaSol).
Maltese: Id-doża hija 2.5mg fenbendazole kull kg tal-piż tal-ġisem kull ġurnata (ekwivalenti għal 0.0125ml
English: Stir until content in the medication tank is visibly homogeneous.
Maltese: Ħawwad sakemm il-kontenut fit-tank tal-medikazzjoni jkun viżibilment omoġenju.
English: During treatment, after complete consumption of the medicated water, animals must be allowed access to unmedicated drinking water as soon as possible.
Maltese: Waqt żmien it-trattament, wara l-konsum komplet tal-ilma medikat, l-annimali għandhom jingħataw aċċess għall-ilma mhux medikat fl-iqsar żmien possibli.
English: Day 1 amount of product
Maltese: Ġurnata 1
English: No adverse reactions have been observed at up to 2.5-fold the maximum recommended dose of 2 mg fenbendazole/ kg body weight in layers and broilers (aged 21 days).
Maltese: L-ebda effetti mhux mixtieqa ma ġew osservati fit-tiġieġ tal-bajd u tal-laħam (ta` 21 ġurnata) sa doża 2.5 darbiet mid-doża rakkomandata massima ta`2mg fenbendazole/kg tal-piż tal-ġisem.
English: A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Maltese: MANIFATTUR TAS-SUSTANZA RESPONSABBLI
English: Fenbendazole and its metabolites are distributed throughout the body, reaching highest concentrations in the liver.
Maltese: Fenbendazole u l-metaboliti tiegħu huma distrubwiti mal-ġisem kollu, l-ogħla konċentrazzjoni tkun fil-fwied.
English: The volume of unmedicated water in the stock suspension container has to be calculated taking as a basis the preset injection rate of the dosing pump and the volume of drinking water usually consumed by the animals in between 3 and 24 hours.
Maltese: Il-volum ta' ilma mhux medikat fil-kontenitur tat-taħlita għandu jiġi kkalkolat billi tieħu bħala bażi l-presett tar-rata tal-injezzjoni tal-pompa tad-dożaġġ u lvolum ta' ilma tax-xorb li l-annimali normalment jixorbu bejn 3 sa 24 siegħa.
English: EXPIRY DATE EXP:
Maltese: Sustanzi mhux attivi:
English: Fenbendazole has an ovicidal effect on nematode eggs.
Maltese: HUWA INDIKAT IL-PRODOTT Ħnieżer u tiġieġ
English: Pigs and chickens
Maltese: Ħnieżer
English: For porcine and poultry species the fat MRL relates to ‘skin and fat in natural proportions'.
Maltese: Għall-ispeċi porċini u tjur l-MRL tax xaħam jirrilata ma' ‘ġilda u xaħam fi proporzjoniji et naturali'.
English: : 2 mg fenbendazole per kg body weight per day (equivalent to 0.01 ml Panacur AquaSol) for 5 consecutive days.
Maltese: Capillaria spp: 2mg fenbendazole kull kg tal-piż tal-ġisem kull ġurnata ((ekwivalenti għal 0.01ml Panacur AquaSol)għal 5 ijiem wara xulxin.
English: - Confusion.
Maltese: − Konfużjoni.
English: - Urticaria.
Maltese: − Urtikarja.
English: EU/1/12/771/001 1 plastic vial EU/1/12/771/002 4 plastic vials EU/1/12/771/003 10 plastic vials EU/1/12/771/004 1 glass vial EU/1/12/771/005 4 glass vials EU/1/12/771/006 10 glass vials
Maltese: EU/1/12/771/001 kunjett 1 tal-plastik EU/1/12/771/002 4 kunjetti tal-plastik EU/1/12/771/003 10 kunjetti tal-plastik EU/1/12/771/004 kunjett 1 tal-ħġieġ EU/1/12/771/005 4 kunjetti tal-ħġieġ EU/1/12/771/006 10 kunjetti tal-ħġieġ
English: Teva Gyógyszergyár Zrt.
Maltese: Magyarország Teva Magyarország Zrt Teva Gyógyszergyár Zrt.
English: Date of latest renewal: 22 May 2017
Maltese: Data tal-aħħar tiġdid: 22 ta' Mejju 2017
English: 45.3% (p=0.104) 82.6% (p=0.005)* 88.4% (p=0.002)*
Maltese: 82.6% (p=0.005)* 88.4% (p=0.002)*
English: Pam 90 mg
Maltese: 90 mg
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 16 August 2012
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 16 ta' Awwissu 2012
English: Thrombocytopenia, leukopenia
Maltese: Thromboċitopenja, lewkopenja
English: Manufacturer Pharmachemie B.V. Swensweg 5
Maltese: Manifattur Pharmachemie B.V. Swensweg 5
English: Luxembourg/Luxemburg Teva Pharma Belgium N.V./S.A./AG, Belgique/Belgien
Maltese: Teva Pharma Belgium N.V./S.A./AG
English: Teva Pharmaceuticals Slovakia s.r.o.
Maltese: Slovenská republika Teva Pharmaceuticals Slovakia s.r.o.
English: • Risk Management Plan (RMP)
Maltese: • Pjan tal-ġestjoni tar-riskju(RMP)
English: Proportion of patients with SREs (%) p-value
Maltese: Proporzjon ta' pazjenti b'SREs (%)
English: Pliva Ljubljana d.o.o.
Maltese: Hrvatska Pliva Hrvatska d.o.o
English: Pack sizes of 1, 4 or 10 vials.
Maltese: Il-pakketti fihom 1, 4 jew 10 kunjetti.
English: Uncommon: Rare:
Maltese: Mhux komuni: Rari:
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 apprezzabli 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: − A kidney function disorder called Fanconi syndrome (will normally be determined by your doctor with certain urine tests).
Maltese: − Disturb fil-funzjoni tal-kliewi msejjaħ sindrome Fanconi (normalment se jkun determinat mit tabib tiegħek permezz ta' ċerti testijiet tal-awrina).
English: CLcr is calculated from serum creatinine using the Cockcroft-Gault formula.
Maltese: CLcr tiġi kkalkulata mill-krejatinina fis-serum bil-formula CockcroftGault .
English: MARKETING AUTHORISATION NUMBER(S) EU/1/12/771/001-006
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/12/771/001-006
English: Baseline creatinine clearance (ml/min)
Maltese: Tneħħija tal-kreatinina mal-linja bażi (ml/min)
English: 10 x 5 ml vials
Maltese: 10 x 5 ml kunjetti
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-proteinifil-plażmahuwa baxx, bi proporzjonmhux marbutli jvarjaminn60% f'2 ng/mlsa 77% f'2000 ng/mlta' zoledronic acid.
English: Pam 90 mg zoledronic acid 4 mg
Maltese: 90 mg zoledronic acid 4 mg
English: 4 x 5 ml vials
Maltese: 4 x 5 ml kunjetti
English: Prilaz baruna Filipovića 25
Maltese: PLIVA Croatia Ltd Prilaz baruna Filipovića 25 10 000 Zagreb
English: Convulsions, hypoaesthesia and tetany (secondary to hypocalcaemia)
Maltese: Konvulżjonijiet, ipoaestesija u tetanja (kawża ta' ipokalċimija)
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 titieħed stima mid-data disponibbli).
English: • Hypersensitivity to the active substance, to other bisphosphonates or to any of the excipients listed in section 6.1
Maltese: • Sensittività eċċessiva għas-sustanza attiva, għal bisfosfonati oħra jew għal kwalunkwe wieħed mill-eċċipjenti elenkati f'sezzjoni 6.1
English: The adverse reactions ranked under headings of frequency, are presented in Table 6.
Maltese: Ir-reazzjonijiet avversi kklassifikati taħt ittitli ta' frekwenza, huma elekati f'Tabella 6.
English: Patients aged 65 years and over
Maltese: sena sa 17-il sena
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 imperfecta severa (tipi I,III u IV) tqabblu ma' pamidronate mogħti ġol-vina fi studju wieħed internazzjonali, multiċentriku, randomised, open labelb'74 u 76 pazjent f'kull grupp ta' kura, rispettivament.
English: Table 6: Adverse reactions observed in paediatric patients with severe osteogenesis imperfecta1.
Maltese: Tabella 6: Reazzjonijiet avversi osservati f'pazjenti pedjatriċi b'osteoġenesi imperfecta severa Disturbi fis-sistema nervuża
English: Cyclic Olefin Polymer (COP) plastic vial or clear glass vial (type I) with chlorobutyl/butyl flurotec stopper and aluminium cap with plastic flip-off cap.
Maltese: Kunjett tal-plastik ta' Cyclic Olefin Polymer (COP) jew kunjett tal-ħġieġ ċar (tip I) b'tapp talchlorobutyl/butyl flurotec u għatu tal-aluminju b'għatu tal-plastik li jinqala' bis-saba'.
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 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 mill-ġisem bi proċess li fih tliet fażijiet: proċess mgħaġġel b'żewġ fażijiet li jneħħi l-mediċina miċ-ċirkolazzjoni sistemika, b'half-lives ta' t½α0.24 u t½β 1.87 sigħat, segwit minn fażi ta' eliminazzjoni twila b'half-life ta' eliminazzjoni terminali ta' t½γ 146 sigħat.
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 tal-bisphosphonate).
English: Zoledronic Acid Teva is contraindicated in breast-feeding women (see section 4.3).
Maltese: Zoledronic acid Teva huwa kontra-indikat f'nisa li qed ireddgħu (ara sezzjoni 4.3).
English: Batch
Maltese: Pam
English: In the clinical studies, patients with serum creatinine > 400 μmol/l or > 4.5 mg/dl were excluded.
Maltese: Fl-istudji kliniċi, pazjenti li kellhom krejatinina fis-serum ta' >400 µmol/l jew >4.5 mg/dl kienu esklużi.
English: Hypocalcaemia is an important identified risk with Zoledronic Acid Teva in the approved indications.
Maltese: L-ipokalċimija hija riskju identifikat importanti b'Zoledronic acid Teva meta fl-indikazzjonijiet approvati.
English: Studies with glass bottles, as well as several types of infusion bags and infusion lines made from polyvinylchloride, polyethylene and polypropylene (prefilled with sodium chloride 9 mg/ml (0.9%) solution for injection or 5% w/v glucose solution), showed no incompatibility.
Maltese: Studji fuq fliexken tal-ħġieġ, kif ukoll diversi tipi ta' boroż tal-infużjoni u pajpijiet tal-infużjoni magħmula minn polyvinylchloride, polyethylene u polypropylene (mimlijin minn qabel b'soluzzjoni għall-injezzjoni ta' 9 mg/ml (0.9%) ta' sodium chloride jew 5% w/v ta' glucose), ma wrewx inkompattibilità.
English: In view of the potential impact of zoledronic acid on renal function, the lack of clinical safety data in patients with severe renal impairment (in clinical trials defined as serum creatinine ≥ 400 μmol/l or ≥ 4.5 mg/dl for patients with TIH and ≥ 265 μmol/l or ≥ 3.0 mg/dl for patients with cancer and bone metastases, respectively) at baseline and only limited pharmacokinetic data in patients with severe renal impairment at baseline (creatinine clearance < 30 ml/min), the use of Zoledronic Acid Teva is not recommended in patients with severe renal impairment.
Maltese: Minħabba l-impatt potenzjali ta' zoledronic acid fuq il-funzjoni tal-kliewi, u minħabba nuqqas ta' tagħrif kliniku dwar is-sigurtà f'pazjenti b'indeboliment sever tal-kliewi (definit fi provi kliniċi bħala livell ta' kreatinina fis-serum ta' ≥400 µmol/l jew ≥4.5 mg/dl għal pazjenti b' TIH u ≥265 µmol/l jew ≥3.0 mg/dl għal pazjenti b' kanċer u metastasi fl-għadam, rispettivament) fil-linja bażi u minħabba ttagħrif farmakokinetiku limitat f'pazjenti li fil-linja bażi għandhom indeboliment sever fil-funzjoni talkliewi (tneħħija tal-kreatinina <30 ml/min), l-użu ta' Zoledronic acid Teva f'pazjenti b'indeboliment sever fil-funzjoni tal-kliewi mhux rakkomandat.
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 Teva, pazjenti b'kreatinina fis-serum ta' >265µmol/l jew >3.0 mg/dl kienu esklużi.
English: Vomiting, nausea
Maltese: Tqallih, rimettar, tnaqqis fl-aptit
English: Bradycardia, cardiac arrhythmia (secondary to hypocalcaemia)
Maltese: Bradikardja, arritmija tal-qalb (kawża ta' ipokalċemija)
English: For storage condition after dilution of the medicinal product, see section 6.3.
Maltese: Għall-kundizzjonijiet ta' ħażna wara d-dilwizzjoni tal-prodott mediċinali, ara sezzjoni 6.3.
English: LIST OF EXCIPIENTS Excipients: mannitol, sodium citrate and water for injections.
Maltese: TA' EĊĊIPJENTI Eċċipjenti: mannitol, sodium citrate, ilma għall-injezzjonijiet.
English: Patients who have received doses higher than those recommended (see section 4.2) should be carefully monitored, since renal function impairment (including renal failure) and serum electrolyte (including calcium, phosphorus and magnesium) abnormalities have been observed.
Maltese: Pazjenti li ngħataw dożi ogħla minn dawk rakkommandati (ara sezzjoni 4.2) għandhom jiġu sorveljati bir-reqqa peress li dehru indeboliment tal-funzjoni renali (inkluża insuffiċjenza renali) u anormalitajiet tal-elettroliti fis-serum (inklużi calcium, phosphorus u magnesium).
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, biproporzjon ta' konċentrazzjonimedja ta' demmgħalplażmata' 0.59f'firxa ta' konċentrazzjonijietta' 30 ng/ml sa 5000 ng/ml.
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: 1Adverse 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 Reazzjonijiet avversi li seħħew bi frekwenzi <5% kienu stmati b'mod mediku u intwera li dawn ilkażijiet kienu konsistenti mal-profil ta' sigurtà stabbilit tajjeb ta' zoledronic acid (ara sezzjoni 4.8).
English: The following are the important identified risks with zoledronic acid in the approved indications: Renal function impairment, osteonecrosis of the jaw, acute phase reaction, hypocalcaemia, atrial fibrillation, anaphylaxis, interstitial lung disease.
Maltese: Indeboliment tal-funzjoni renali, osteonekrożi tax-xedaq, reazzjoni ta' fażi akuta, ipokalċimija, fibrillazzjoni tal-atrija, anafilassi, marda tal-interstizju tal-pulmun.
English: Muscle spasms, osteonecrosis of the jaw
Maltese: Spażmifil-muskoli, osteonekrożi tax-xedaq
English: What Zoledronic Acid Teva contains
Maltese: Doża ta' Zoledronic acid Teva rakkomandata*
English: One vial contains 4 mg zoledronic acid, (as monohydrate).
Maltese: Kunjett wieħed fih 4 mg zoledronic acid, (bħala monohydrate.
English: In a pooled analysis of safety data from zoledronic acid registration trials for the prevention of skeletal-related events in patients with advanced malignancies involving bone, the frequency of renal impairment adverse events suspected to be related to zoledronic acid (adverse reactions) was as follows: multiple myeloma (3.2%), prostate cancer (3.1%), breast cancer (4.3%), lung and other solid tumours (3.2%).
Maltese: F'ġabra ta' diversi analiżidwar is-sigurtà waqt il-provi ta' reġistrazzjoni ta' zoledronic acid għall-prevenzjoni ta' problemi skeletriċi f'pazjenti li għandhom kanċer avvanzat li jinvolvi l-għadam, il-frekwenza ta' episodji avversi ta' indeboliment tal-kliewi li jistgħu jkunu relatati ma' zoledronic acid (reazzjonijiet avversi) kienet kif ġej: majeloma multipla (3.2%), kanċer tal-prostata (3.1%), kanċer tas-sider (4.3%), tumuri tal-pulmun u tumuri solidi oħrajn (3.2%).
English: - Low level of magnesium and potassium in the blood.
Maltese: − Livell baxx ta' magnesium u potassium fid-demm.
English: Each vial contains 5 ml of concentrate.
Maltese: Kull kunjett fih 5 ml ta' konċentrat.
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 ta' darba jew multipli fuq medda ta' 5-minuti u 15-il minuta, u f'dożi ta' 2,4,8, u 16 mg ta' zoledronic acid f'64 pazjent b'metastasi fl-għadam, taw tagħrif farmakokinetiku hekk kif ġej, u li nstab li ma kienux jiddependu fuq id-doża.
English: Rare (may affect up to 1 in 1,000 people):
Maltese: Rari (tista' taffettwa sa persuna 1 minn kull 1,000 persuna):
English: - Studies with several types of infusion lines made from polyvinylchloride, polyethylene and polypropylene showed no incompatibility with zoledronic acid.
Maltese: - Fi studji li saru b'diversi tipi ta' pajpijiet għall-infużjoni magħmulin minn polyvinyl chloride, polyethylene u polypropylene ma deherx li kien hemm xi inkompatibbiltà ma' zoledronic acid.
English: Zoledronic acid Teva 4 mg/5 ml concentrate for solution for infusion, further diluted in 100 ml (see section 6.6), should be given as a single intravenous infusion in no less than 15 minutes.
Maltese: Zoledronic acid Teva 4 mg/5 ml konċentrat għal soluzzjoni għall-infużjoni, iddilwit aktar f'100 ml (ara sezzjoni 6.6), għandu jingħata bħala infużjoni waħda għal ġol-vini f'mhux inqas minn 15-il minuta.
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: Iż-żmien medjan biex jerġa' jogħla (livell ta' kaljċu fis-serum ikkoreġut għall-albumina reġa' tela' għal≥ 2.9 mmol/l) kien ta' 30 sa 40 ġurnata għall-pazjenti fuq kura b'zoledronic acid kontra 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: While on treatment, invasive dental procedures should be performed only after careful consideration and be avoided in close proximity to zoledronic acid administration.
Maltese: Meta jkunu qed jingħataw il-kura, proċeduri dentali invasivi għandhom isiru biss wara kunsiderazzjoni birreqqa u għandhom jiġu evitati meta jingħataw qrib ħafna amministrazzjoni ta' zoledronic acid.
English: Dizziness, paraesthesia, dysgeusia, hypoaesthesia, hyperaesthesia, tremor, somnolence
Maltese: Sturdament, parasteżija, disgweżja, ipoesteżija, iperesteżija, tregħid, ħedla ta' ngħas
English: 0.5 mg/dl or 44 μmol/l; - For patients with an abnormal baseline creatinine (> 1.4 mg/dl or > 124 μmol/l), an increase of
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: Zoledronic acid 4 mg was also studied in a double-blind, randomised, placebo-controlled trial in 228 patients with documented bone metastases from breast cancer to evaluate the effect of 4 mg zoledronic acid on the skeletal related event (SRE) rate ratio, calculated as the total number of SRE events (excluding hypercalcaemia and adjusted for prior fracture), divided by the total risk period.
Maltese: Zoledronic acid 4 mg kien studjat ukoll fi prova double-blind, randomised, kontrollata bi plaċebo f'228 pazjent b'metastasi tal-għadam dokumentata minn kanċer tas-sider sabiex ikun evalwat l-effett ta' 4 mg ta' zoledronic acid fuq ir-rata tal-proporzjon tal-każijiet relatati mal-għadam (SRE), kalkulat bħala n-numru totali ta' każijiet ta' SRE (bl-esklużjoni ta' iperkalċimja u rranġata għall-qabel il-ksur), diviż mat-totali tal-perijodu ta' riskju.
English: After dilution: Chemical and physical in-use stability has been demonstrated for 24 hours at 2°C - 8°C and 25°C.
Maltese: 2°C-8°C u 25°C.