FrancophonIA/ELRC3.0 huggingface dataset:
English: Creatine kinase (CK) Creatine kinase isoenzym MB (CKMB)
Maltese: Creatine kinase isoenzym MB (CKMB) Lactate dehydrogenase (LDH)
English: Cyanokit is to be administered together with appropriate decontamination and supportive measures (see section 4.4).
Maltese: Cyanokit għandu jingħata flimkien ma' miżuri adegwati ta' dekontaminazzjoni u sapport (ara sezzjoni 4.4).
English: • transport in the desert (4 days submitted to temperatures ranging from 5 to 60°C) and
Maltese: • trasport fid-deżert (4 ijiem espost għal temperaturi li jvarjaw minn 5°C sa 60°C) u
English: Eosinophils
Maltese: Eosinofili
English: Adults: The subsequent dose of Cyanokit is 5 g (2 x 100 mL).
Maltese: Id-doża sussegwenti ta' Cyanokit hi ta' 5 g (2 x 100 mL).
English: • coloured plasma, which may cause artificial elevation or reduction in the levels of certain laboratory parameters.
Maltese: • plażma kkulurita, li tista' tikkawża żieda jew tnaqqis artifiċjali fil-livelli ta' ċerti parametri tal laboratorju.
English: Based on in vitro studies and pharmacokinetic data obtained in healthy volunteers the following table describes interference with laboratory tests that may be observed following a 5 g dose of hydroxocobalamin.
Maltese: Ibbażat fuq studji in vitro u informazzjoni farmakokinetika miksuba f'voluntiera b'saħħithom, ittabella li ġejja tiddeskrivi l-interferenza mat-testijiet tal-laboratorju li tista' tkun osservata wara doża ta' 5 g ta' hydroxocobalamin.
English: Mean corpuscular haemoglobin (MCH) Mean corpuscular haemoglobin concentration (MCHC)
Maltese: Emoglobina (Hb) Medja ta' emoglobina korpuskolari (MCH) Medja talkonċentrazzjoni ta' emoglobina korpuskolari (MCHC)
English: Initial dose Adults: The initial dose of Cyanokit is 5 g (2 x 100 mL).
Maltese: Id-doża inizjali ta' Cyanokit hi ta' 5 g (2 x 100 mL).
English: You will have the first infusion of Cyanokit over 15 minutes.
Maltese: Ser tingħata l-ewwel infużjoni ta' Cyanokit fuq perjodu ta' 15-il minuta.
English: Limited data on children (0 to 18 years old) treated with hydroxocobalamin did not show any difference in the safety profile of hydroxocobalamin between adults and children.
Maltese: Dejta limitata dwar tfal (0 sa 18-il sena) ikkurati b'hydroxocobalamin ma wriet l-ebda differenza filprofil tas-sigurtà ta' hydroxocobalamin bejn persuni adulti u tfal.
English: Memory impairment; dizziness.
Maltese: Indeboliment fil-memorja; sturdament.
English: Hydroxocobalamin reduced whole blood cyanide concentrations from about 120 nmol/mL to 30-40 nmol/mL by the end of the infusion compared with 70 nmol/mL in dogs receiving sodium chloride 9 mg/mL alone.
Maltese: Hydroxocobalamin naqqas konċentrazzjonijiet sħaħ ta' cyanide fid-demm minn madwar 120 nmol/mL sa 30-40 nmol/mL sat-tmiem ta' l-infużjoni meta mqabbel ma' 70 nmol/mL fi klieb li kienu qed jirċievu 9 mg/mL sodium chloride biss.
English: • fluid in the chest (pleural effusion)
Maltese: • fluwidu fis-sider (ħruġ ta' likwidu mill-plewra)
English: Initial dose of Cyanokit is administered as an intravenous infusion over 15 minutes.
Maltese: Id-doża inizjali ta' Cyanokit tingħata bħala infużjoni ġol-vini fuq perjodu ta' 15-il minuta.
English: The 75 mg/kg and 150 mg/kg doses are approximately equivalent to 5 g and 10 g of hydroxocobalamin, respectively, in humans, not only on a body weight basis but also on Cmax basis of hydroxocobalamin [total cobalamins-(III), see section 5.2].
Maltese: Id-dożi ta' 75 mg/kg u 150 mg/kg huma ekwivalenti bejn wieħed u ieħor għal 5 g u 10 g ta' hydroxocobalamin, rispettivament, fil-bnedmin, mhux biss fuq bażi ta' piż tal-ġisem iżda wkoll fuq bażi tas-Cmax ta' hydroxocobalamin [cobalamins-(III) totali, ara sezzjoni 5.2].
English: MEDICAL OR HEALTH CARE PROFESSIONALS EDUCATIONAL STICKER
Maltese: STICKER EDUKATTIV MEDIKU JEW TAL-PROFESSJONISTI
English: Initial dose in g in mL
Maltese: Doża inizjali fi g f'mL
English: Dogs then received sodium chloride 9 mg/mL, 75 mg/kg or 150 mg/kg hydroxocobalamin, administered intravenously over 7.5 minutes.
Maltese: Il-klieb imbagħad irċivew 9 mg/mL ta' sodium chloride, 75 mg/kg jew 150 mg/kg hydroxocobalamin, li ngħata minn ġol-vina fuq perjodu ta' 7.5 minuti.
English: Among 144 patients not in initial cardiac arrest whose outcomes were known, 118 (82%) survived.
Maltese: Fost 144 pazjent li ma kellhomx waqfien inizjali kardijaku li r-riżultati tagħhom kienu magħrufa, 118 (82%) baqgħu ħajjin.
English: Duration of interference after a 5 g dose
Maltese: It-tul ta' żmien ta' l-interferenza wara doża ta' 5 g
English: Pharmacotherapeutic group: Antidotes, ATC code: V03AB33
Maltese: Antidoti, Kodiċi ATC:
English: Hydrochloric acid (for pH-adjustment)
Maltese: Hydrochloric acid (għal aġġustament tal-pH).
English: Dose-proportional pharmacokinetics were observed following single dose intravenous administration of 2.5 to 10 g of Cyanokit in healthy volunteers.
Maltese: Il-farmakokinetika proporzjonali għad-doża kienet osservata wara l-għoti ta' doża waħda ġol-vini ta' 2.5 sa 10 g ta' Cyanokit f'voluntiera b'saħħithom.
English: Abdominal discomfort, dyspepsia, diarrhoea, vomiting, nausea, dysphagia.
Maltese: Skomdu addominali, dispepsja, dijarea, rimettar, nawsja, disfaġja.
English: Furthermore, in 34 patients with known cyanide concentrations above the lethal threshold (≥ 100 µmol/L), 21 (62%) survived following treatment with hydroxocobalamin.
Maltese: Kif ukoll, fi 34 pazjent b'konċentrazzjonijiet magħrufa ta' cyanide iktar mill-limitu letali (≥ 100 µmol/L), 21 (62%) baqgħu ħajjin wara t-trattament b'hydroxocobalamin.
English: • swelling, irritation, redness.
Maltese: • nefħa, irritazzjoni, ħmura.
English: Administration of hydroxocobalamin was generally associated with a normalisation of blood pressure (systolic blood pressure > 90 mmHg) in 17 of 21 patients (81%) who had low blood pressure (systolic blood pressure > 0 and ≤ 90 mmHg) after exposure to cyanide.
Maltese: L-għoti ta' hydroxocobalamin kien ġeneralment assoċjat ma' normalizazzjoni tal-pressjoni tad-demm (pressjoni sistolika tad-demm ta' > 90 mmHg) fi 17 minn 21 pazjent (81%) li kellhom pressjoni taddemm baxxa (pressjoni sistolika tad-demm ta' > 0 u ≤ 90 mmHg) wara espożizzjoni għal cyanide.
English: What is in this leaflet:
Maltese: Analizzaturi użati:
English: Interference with haemodialysis
Maltese: Interferenza mal-emodijalisi
English: Swelling, irritation, redness.
Maltese: Disturbi fl-għajnejn Nefħa, irritazzjoni, ħmura.
English: Other medicines and Cyanokit
Maltese: Mediċini oħra u Cyanokit
English: However, because of the limitations of the available data, it is not possible to apply frequency estimations:
Maltese: Madankollu, minħabba l-limitazzjonijiet ta' l-informazzjoni disponibbli, mhuwiex possibbli li jkunu applikati listimi tal-frekwenza:
English: One transfer device.
Maltese: Żewġ strumenti għat-trasferiment.
English: Out of the 20 paediatric patients without initial cardiac arrest, 18 (90%) survived, of whom 4 with sequelae.
Maltese: Fost l-20 pazjenti pedjatriċi li ma kellhomx waqfien kardijaku inizjali, 18 (90%) baqgħu ħajjin, li minnhom 4 kellhom sequelae.
English: Common signs and symptoms of cyanide poisoning include: nausea, vomiting, headache, altered mental status (e.g. confusion, disorientation), chest tightness, dyspnoea, tachypnoea or hyperpnoea (early), bradypnoea or apnoea (late), hypertension (early) or hypotension (late), cardiovascular collapse, seizures or coma, mydriasis, and plasma lactate concentration > 8 mmol/L.
Maltese: Sinjali komuni u sintomi ta' avvelenament b'cyanide jinkludu: nawsja, rimettar, uġigħ ta' ras, stat mentali mibdul (eż. konfużjoni, diżorjentament), tagħfis fis-sider, qtugħ ta' nifs, takipnea jew iperpnea (bikrija), bradipnea jew apnea (tardiva), pressjoni għolja (bikrija) jew pressjoni baxxa (tardiva), kollass kardjovaskulari, puplesiji jew koma, midrijasi, u konċentrazzjoni ta' plażma lactate ta' > 8 mmol/L.
English: MM/YYYY
Maltese: TAS-SAĦĦA
English: Sodium chloride 9 mg/mL (0.9%) solution for injection is the recommended diluent.
Maltese: Soluzzjoni għall-injezzjoni ta' 9 mg/mL ta' sodium chloride (0.9%) hi ddiluwent rakkomandat.
English: Paediatric population: In infants to adolescents (0 to 18 years old), the maximum total recommended dose is 140 mg/kg not exceeding 10 g.
Maltese: Fi tfal żgħar sa adolexxenti (0 sa 18-il sena), id-doża massima totali rakkomandata hi ta' 140 mg/kg, u ma taqbiżx 10 g.
English: The presence of altered mental status (confusion and disorientation) and/or mydriasis is suggestive of true cyanide poisoning.
Maltese: Il-preżenza ta' stat mentali mibdul (konfużjoni u diżorjentament) u/jew midrijasi, hija indikattiva ta' avvelenament reali b'cyanide.
English: The effectiveness of hydroxocobalamin was examined in a controlled study in cyanide-poisoned adult dogs.
Maltese: L-effettività ta' hydroxocobalamin kienet eżaminata fi studju kkontrollat fi klieb adulti li kienu avvelenati b'cyanide.
English: The predominant mean half-life of free and total cobalamins-(III) was approximately 26 to 31 hours at the 5 and 10 g dose level.
Maltese: Il-medja predominanti ħielsa u totali tal-half-life ta' cobalamins-(III) kienet ta' madwar 26 sa 31 siegħa fil-livell tad-doża ta' 5 u 10 g.
English: Mean free and total cobalamins-(III) Cmax values of 113 and 579 µg eq/mL, respectively, were determined following a dose of 5 g Cyanokit (the recommended initial dose).
Maltese: Il-medja tal-valuri tas-Cmax ta' cobalamins-(III) ħielsa u dawk totali, ta' 113 u 579 µg eq/mL rispettivament, kienet stabbilita wara doża ta' 5 g ta' Cyanokit (id-doża inizjali rakkomandata).
English: Cyanokit contains the active substance hydroxocobalamin.
Maltese: Cyanokit fih is-sustanza attvia hydroxocobalamin.
English: Because of its deep red colour, hydroxocobalamin has the potential to interfere with determination of laboratory parameters (e.g. clinical chemistry, haematology, coagulation, and urine parameters).
Maltese: Minħabba l-kulur aħmar skur tiegħu, hydroxocobalamin għandu l-potenzjal li jinterferixxi maddeterminazzjoni tal-parametri tal-laboratorju (eż. parametri ta' kimika klinika, ematoloġija, koagulazzjoni u awrina).
English: Subsequent dose
Maltese: Doża sussegwenti
English: Urine colouration may last up to 35 days after administration of Cyanokit.
Maltese: Il-lewn tal-urina jista' jdum sa 35 ġurnata wara l-għoti ta' Cyanokit.
English: The mean total amount of cobalamins-(III) excreted in urine during the collection period of 72 hours was approximately 60% of a 5 g dose and approximately 50% of a 10 g dose of Cyanokit.
Maltese: Il-medja ta' l-ammont totali ta' cobalamins-(III) li tneħħew fl-awrina matul il-perjodu ta' ġbir ta' 72 siegħa kienet ta' madwar 60% ta' doża ta' 5 g u madwar 50% ta' doża ta' 10 g ta' Cyanokit.
English: The pharmacokinetics of total cobalamins-(III) in this population may be affected by the body's cyanide load, since cyanocobalamin was reported to exhibit a 2-3 times lower half-life than total cobalamins-(III) in healthy volunteers.
Maltese: Il-farmakokinetika ta' cobalamins-(III) totali f'din ilpopolazzjoni tista' tkun affettwata mill-ammont ta' cyanide fil-ġisem, għax cyanocobalamin kien irrappurtat li juri half-life li hi 2-3 darbiet iktar baxxa mil-cobalamins-(III) totali f'voluntiera b'saħħithom.
English: When normalized for body weight, male and female subjects revealed no major differences in plasma and urinary pharmacokinetic parameters of free and total cobalamins-(III) following the administration of 5 g or 10 g Cyanokit.
Maltese: Meta normalizzati għal piż tal-ġisem, pazjenti rġiel u nisa ma żvelaw l-ebda differenzi maġġuri filplażma u fil-parametri farmakokinetiċi ta' l-awrina ta' cobalamins-(III) ħielsa u totali, wara l-għoti ta' 5 g jew 10 g ta' Cyanokit.
English: Cyanokit must not be mixed with diluents other than sodium chloride 9 mg/mL (0.9%) solution for injection or Lactated Ringer solution or glucose 50 mg/mL (5%) solution for injection.
Maltese: Cyanokit m'għandux jitħallat ma' diluwenti oħrajn ħlief 9 mg/mL ta' sodium chloride (0.9%) soluzzjoni għall-injezzjoni jew soluzzjoni Lactated Ringer jew glucose 50 mg/mL (5%) soluzzjoni għall-injezzjoni.
English: Dark red crystalline powder.
Maltese: Trab kristallin aħmar skur.
English: • usual transport (15 days submitted to temperatures ranging from 5 to 40°C)
Maltese: • waqt it-trasport normali (15-il jum espost għal temperaturi li jvarjaw minn 5°C sa 40°C)
English: In order to reflect the exposure to the sum of all derivatives, pharmacokinetics of cobalamins-(III) were investigated instead of hydroxocobalamin, requiring the concentration unit µg eq/mL (i.e. cobalamin-(III) entity without specific ligand).
Maltese: Sabiex tirrifletti l- espożizzjoni għat-total tad-derivattivi kollha, ilfarmakokinetika ta' cobalamins-(III) kienet investigata minflok dik ta' hydroxocobalamin, li kienet teħtieġ l-unità tal-konċentrazzjoni µg eq/mL (i.e. l-entità cobalamin-(III) mingħajr ligand speċifiku).
English: In this setting hypotension and/or a plasma lactate concentration ≥ 10 mmol/L (higher than the one mentioned under signs and symptoms due to the fact that carbon monoxide contributes to lactic acidaemia) are highly suggestive of cyanide poisoning.
Maltese: F'dan l-isfond, ipotensjoni u/jew konċentrazzjoni ta' plażma lactate ta' ≥ 10 mmol/L (ogħla minn dik imsemmija taħt ‘sinjali u sintomi' minħabba l-fatt li carbon monoxide jikkontribwixxi għal lactic acidaemia) huma indikazzjoni ċara ħafna ta' avvelenament b'cyanide.
English: The survival rate of 41% depended very much on the clinical situation.
Maltese: Ir-rata ta' sopravivenza ta' 41% kienet tiddependi ħafna fuq issitwazzjoni klinika.
English: A decrease in blood pressure was observed in cyanide-poisoned patients.
Maltese: Tnaqqis fil-pressjoni tad-demm kien osservat f'pazjenti avvelenati b'cyanide.
English: • freezing/defrosting cycles (15 days submitted to temperatures ranging from -20 to 40°C).
Maltese: • ċikli ta' ffriżar/iddefrostjar (15-il jum espost għal temperaturi li jvarjaw minn -20°C sa 40°C).
English: Each vial contains 2.5 g of hydroxocobalamin.
Maltese: Kull kunjett fih 2.5 g ta' hydroxocobalamin.
English: A total of 245 patients with suspected or known cyanide-poisoning were included in the clinical studies of the efficacy of hydroxocobalamin as an antidote.
Maltese: Total ta' 245 pazjent b'avvelenament suspettat jew magħruf ta' cyanide, kienu inklużi fl-istudji kliniċi dwar l-effikaċja ta' hydroxocobalamin bħala antidotu.
English: Oxalate crystals have been observed in the urine of healthy volunteers given hydroxocobalamin.
Maltese: Kristalli ta' oxalate kienu osservati fl-awrina ta' voluntiera f'saħħithom mogħtija hydroxocobalamin.
English: • inflammation in the part of the body where the medicine was infused.
Maltese: • infjammazzjoni fil-parti tal-ġisem fejn il-mediċina ngħatat bħala infużjoni.
English: Depending upon the severity of the poisoning and the clinical response (see section 4.4), a second dose may be administered.
Maltese: Doża sussegwenti Skond is-serjeta` ta' l-avvelenament u r-rispons kliniku (ara sezzjoni 4.4), tista' tingħata t-tieni doża.
English: Activated partial thromboplastin time (aPTT)
Maltese: Ħin tattromboplastin parzjali attivat (aPTT)
English: In general, the effectiveness of hydroxocobalamin in paediatric patients was similar to that of adults.
Maltese: B'mod ġenerali, l-effettività ta' hydroxocobalamin filpazjenti pedjatriċi kienet simili għal dik ta' pazjenti adulti.
English: Initial dose Adults: The initial dose of Cyanokit is 5 g (200 mL, complete volume of reconstituted solution).
Maltese: Id-doża inizjali ta' Cyanokit hi ta' 5 g (200 mL, volum komplut tas-soluzzjoni rikostitwita).
English: Chemical and physical in-use stability of the reconstituted solution with sodium chloride 9 mg/mL (0.9%) has been demonstrated for 6 hours at a temperature between 2°C to 40°C.
Maltese: L-istabbiltà kimika u fiżika waqt l-użu tas-soluzzjoni rikostitwita b'sodium chloride 9 mg/mL (0.9%) intweriet għal 6 sigħat f'temperatura ta' bejn 2°C sa 40°C.
English: Following intravenous administration of Cyanokit, significant binding to plasma proteins and low molecular weight physiological compounds occurs, to form various cobalamin-(III) complexes by replacing the hydroxo ligand.
Maltese: Wara l-għoti ġol-vini ta' Cyanokit, iseħħ tgħaqqid sinjifikanti mal-proteini tal-plażma u piż molekulari baxx ta' komposti fiżjoloġiċi, biex jifforma kumplessi varji ta' cobalamin-(III) bis-sostituzzjoni talligand hydroxo.
English: The dose of 150 mg/kg approximately corresponds to the maximum recommended human dose.
Maltese: Id-doża ta' 150 mg/kg tikkorrispondi bejn wieħed u ieħor għad-doża umana massima rakkomandata.
English: The vial contains 5 g of hydroxocobalamin.
Maltese: Il-kunjett fih 5 g ta' hydroxocobalamin.
English: • irregular heart beat
Maltese: • diffikultà biex tibla'.
English: Cases of acute renal failure with acute tubular necrosis, renal impairment and urine calcium oxalate crystals present have been reported in patients treated with hydroxocobalamin following known or suspected cyanide poisoning.
Maltese: Każijiet ta' insuffiċjenza akuta tal-kliewi b'nekrosi tubulari akuta, indeboliment tal-kliewi u l-preżenza ta' kristalli ta' calcium oxalate fl-awrina ġew irrappurtati f'pazjenti ttrattati b'hydroxocobalamin wara avvelenament magħruf jew issuspettat ta' cyanide.
English: • The other ingredient is hydrochloric acid (for pH adjustment).
Maltese: • Is-sustanza l-oħra hi hydrochloric acid (għal aġġustament tal-pH).
English: Cyanokit may cause red discolouration of the plasma, which may cause artificial elevation or reduction in the levels of certain laboratory parameters (see section 4.4).
Maltese: Cyanokit jista' jikkawża tibdil ħamrani tal-plażma, li jista' jikkawża żieda jew tnaqqis artifiċjali fillivelli ta' ċerti parametri tal-laboratorju (ara sezzjoni 4.4).
English: • skin redness, nettle rash (urticaria) or itching.
Maltese: • leżjonijiet qishom bżieżaq fuq il-ġilda (raxx bil-ponot).
English: Coagulation
Maltese: Koagulazzjoni
English: Consideration must be given to decontamination measures based on the route of exposure.
Maltese: Trid tingħata konsiderazzjoni għal miżuri ta' dekontaminazzjoni bbażati fuq ir-rotta ta' l-espożizzjoni.
English: Renal and urinary problems
Maltese: Problemi fil-kliewi u fis-sistema urinarja
English: Signs and symptoms of cyanide poisoning
Maltese: Sinjali u sintomi ta' avvelenament b'cyanide
English: Known hypersensitivity to hydroxocobalamin or vitamin B12 must be taken into benefit-risk consideration before administration of Cyanokit, since hypersensitive reactions may occur in patients receiving hydroxocobalamin (see section 4.8).
Maltese: B12 trid tkun ikkunsidrata firrigward tal-benefiċċju-riskju qabel l-għoti ta' Cyanokit, minħabba li jistgħu jseħħu reazzjonijiet minħabba sensittività eċċessiva f'pazjenti li jkunu qed jirċievu hydroxocobalamin (ara sezzjoni 4.8).
English: Hydroxocobalamin will lower blood cyanide concentrations.
Maltese: Hydroxocobalamin ser ibaxxi l-konċentrazzjonijiet ta' cyanide fid-demm.
English: Haemodialysis may be effective in such a circumstance, but is only indicated in the event of significant hydroxocobalamin-related toxicity.
Maltese: L-emodijalisi tista' tkun effettiva f'ċirkustanza bħal din, iżda hi indikata biss f'każ ta' tossiċità sinjifikanti relatata ma' hydroxocobalamin.
English: Similarly, mean free and total cobalamins-(III) Cmax values of 197 and 995 µg eq/mL, respectively, were determined following the dose of 10 g Cyanokit.
Maltese: Bl-istess mod, il-medja tal-valuri ħielsa u totali tas-Cmax ta' cobalamins-(III), ta' 197 u 995 µg eq/mL rispettivament, kienet stabbilita wara doża ta' 10 g ta' Cyanokit.
English: Overall, the total urinary excretion was calculated to be at least 60 to 70% of the administered dose.
Maltese: Globalment, it-tneħħija totali permezz ta' l-awrina kienet ikkalkulata li hi mill-inqas 60 sa 70% taddoża li tkun ingħatat.
English: Cyanokit may interfere with burn assessment (red coloration of the skin) and laboratory tests and may lead to shut down of haemodialysis machines (see SmPC).”
Maltese: Cyanokit jista' jinterferixxi ma' l-evalwazzjoni tal-ħruq (ħmura tal-ġilda) u testijiet tal-laboratorju u jista' jikkawża li l-magni tal-emodijalisi jieqfu (ara Sommarju tal-Karatteristiċi tal-Prodott).
English: Of these 347 subjects, 245 patients had suspected exposure to cyanide at the time of hydroxocobalamin administration.
Maltese: Minn dawn it-347 pazjent, 245 pazjent kellhom espożizzjoni suspettata għal cyanide fil-ħin ta' l-għoti ta' hydroxocobalamin.
English: Of the 213 patients in whom the outcome was known the survival was 58%.
Maltese: Mill-213-il pazjent li fihom ir-riżultat kien magħruf, is-sopravivenza kienet ta' 58%.
English: Only when sodium chloride 9 mg/mL (0.9%) solution for injection is not available, Lactated Ringer solution or glucose 50 mg/mL (5%) solution for injection can also be used.
Maltese: Huwa biss meta soluzzjoni għall-injezzjoni ta' 9 mg/mL ta' sodium chloride (0.9%) ma tkunx disponibbli, li tista' tintuża wkoll soluzzjoni ta' Lactated Ringer jew glucose 50 mg/mL (5%) soluzzjoni għall-injezzjoni.
English: Use with other cyanide antidotes
Maltese: Kumbinazzjoni b'antidotu ieħor ta' cyanide:
English: Doses as high as 15 g have been administered without reported specific dose related adverse reactions.
Maltese: Dożi sa 15 g ingħataw mingħajr ebda rapporti ta' reazzjonijiet avversi speċifiċi relatati mad-doża.
English: Where neurological assessment over time was possible, (96 patients of the 171 patients who presented with neurological symptoms prior to hydroxocobalamin administration), 51 (53%) patients receiving hydroxocobalamin showed improvement or a complete restoration.
Maltese: Fejn l-evalwazzjoni newroloġika fuq perjodu ta' żmien kienet possibbli, (96 pazjent mill-171 pazjent li kellhom sintomi newroloġiċi qabel l-għoti ta' hydroxocobalamin), 51 (53%) tal-pazjenti li kienu qed jirċievu hydroxocobalamin urew titjib jew fejqan sħiħ.
English: Survival at hour 4 and at day 14 was significantly greater in 75 mg/kg and 150 mg/kg hydroxocobalamin dose groups compared with dogs receiving sodium chloride 9 mg/mL alone:
Maltese: Is-sopravivenza f'siegħa 4 u f'jum 14 kienet evidentement akbar fil-gruppi li ngħataw doża ta' 75 mg/kg u 150 mg/kg ta' hydroxocobalamin meta mqabbla ma' klieb li kienu qed jirċievu 9 mg/mL ta' sodium chloride biss:
English: Paediatric population: In infants to adolescents (0 to 18 years old), the initial dose of Cyanokit is 70 mg/kg body weight not exceeding 5 g.
Maltese: Fi tfal żgħar sa adolexxenti (0 sa 18-il sena), id-doża inizjali ta' Cyanokit hi ta' 70 mg/kg piż tal-ġisem, u ma taqbiżx 5 g.
English: Each hydroxocobalamin molecule can bind one cyanide ion by substituting the hydroxo ligand linked to the trivalent cobalt ion to form cyanocobalamin.
Maltese: Kull molekula ta' hydroxocobalamin tista' tingħaqad ma' jone waħda ta' cyanide billi tissostitwixxi l-ligand hydroxo marbut mal-jone trivalenti tal-cobalt biex tifforma cyanocobalamin.
English: Clinical chemistry
Maltese: GĦAMLA FARMAĊEWTIKA
English: Adults: The subsequent dose of Cyanokit is 5 g (200 mL, complete volume of reconstituted solution).
Maltese: Id-doża sussegwenti ta' Cyanokit hi ta' 5 g (200 mL, volum komplut tas-soluzzjoni rikostitwita).
English: Monocytes
Maltese: Monoċiti
English: Paediatric population: In infants to adolescents (0 to 18 years old), the subsequent dose of Cyanokit is 70 mg/kg body weight not exceeding 5 g.
Maltese: Fi tfal żgħar sa adolexxenti (0 sa 18-il sena), id-doża sussegwenti ta' Cyanokit hi ta' 70 mg/kg piż tal-ġisem, u ma taqbiżx 5 g.
English: In particular, liver fibrosis was observed in dogs after administration of hydroxocobalamin for 4 weeks at 300 mg/kg.
Maltese: Partikolarment, il-fibrożi tal-fwied kienet osservata fil-klieb wara l-għoti ta' hydroxocobalamin għal 4 ġimgħat f'doża ta' 300 mg/kg.
English: No studies on fertility have been performed (see section 5.3).
Maltese: Ma sarux studji dwar il-fertilità (ara sezzjoni 5.3).
English: Potassium Chloride
Maltese: Chloride
English: Preparation of Cyanokit
Maltese: Kif jintuża Cyanokit