FrancophonIA/ELRC3.0 huggingface dataset:
English: If you take more Olanzapine Glenmark than you should Patients who have taken more Olanzapine Glenmark than they should have experienced the following symptoms: rapid beating of the heart, agitation/aggressiveness, problems with speech, unusual movements (especially of the face or tongue) and reduced level of consciousness.
Maltese: Jekk tieħu Olanzapine Glenmark aktar milli suppost Pazjenti li ħadu iżjed Olanzapine Glenmark milli suppost kellhom dawn is-sintomi li ġejjin: tħabbit mgħaġġel tal-qalb, aġitazzjoni/aggressività, problemi biex jitkellmu, movimenti mhux tas-soltu (speċjalment tal-ħalq u ta' l-ilsien) u tnaqqis fil-livell ta' koxjenza.
English: NAME OF THE MEDICINAL PRODUCT Olanzapine Glenmark 15 mg tablets Olanzapine
Maltese: Olanzapine Glenmark 15 mg pilloli Olanzapine
English: NAME OF THE MEDICINAL PRODUCT Olanzapine Glenmark 10 mg tablets Olanzapine
Maltese: Olanzapine Glenmark 10 mg pilloli Olanzapine
English: Urinary incontinence, urinary retention Urinary hesitation11
Maltese: Distonja (tinkludi okuloġirazzjoni)11 Diskineżja tardiva11 Amnesija9
English: 6.5 Nature and contents of container Aluminium/aluminium blisters in cartons of 28, 56, 70, 98 tablets per carton.
Maltese: In-natura u tal-kontenitur u ta' dak li hemm ġo fih Folji ta' aluminju/aluminju f'kartun ta' 28, 56, 70, 98 pillola għal kull kartuna.
English: A lower starting dose (5 mg/day) is not routinely indicated but should be considered for those 65 and over when clinical factors warrant (see section 4.4).
Maltese: Doża anqas tal-bidu (5 mg/ġurnata) mhux indikata normalment imma għandha tiġi kkunsidrata għal dawk li għandhom 65 jew fuqhom meta fatturi kliniċi jindikaw hekk (ara taqsima 4.4).
English: Sedation affected mating performance of male rats.
Maltese: Disturb fid-diskors kien ukoll komunement rappurtat.
English: • Rash.
Maltese: OĦRAJN
English: Schizophrenia: The recommended starting dose for olanzapine is 10 mg/day.
Maltese: Id-doża rakkomandata tal-bidu hija 10 mg/ġurnata.
English: Adults Schizophrenia: The recommended starting dose for olanzapine is 10 mg/day.
Maltese: Id-doża tal-bidu rakkomandata għal olanzapine hija 10 mg/ġurnata.
English: In renally impaired patients (creatinine clearance < 10 ml/min) versus healthy subjects, there was no significant difference in mean elimination half-life (37.7 versus 32.4 hr) or clearance (21.2 versus 25.0 l/hr).
Maltese: F'pazjenti b'mard tal-kliewi (tneħħija tal-krejatinina < 10 ml/min) f'paragun ma' pazjenti b'saħħithom, ma kienx hemm differenza sinifikanti fil-medja tal-half life ta' l-eliminazzjoni (37.7 kontra
English: NAME OF THE MEDICINAL PRODUCT Olanzapine Glenmark 20 mg tablets
Maltese: Olanzapine Glenmark 20 mg pilloli
English: Age > 75 years and vascular/mixed type dementia were identified as risk factors for CVAE in association with olanzapine treatment.
Maltese: L-età ta' >75 sena u ddemenzja tat-tip vaskulari jew imħallta kienu identifikati bħala fatturi ta' riskju għal CVAE f'assoċjazzjoni ma' trattament b'olanzapine.
English: NAME OF THE MEDICINAL PRODUCT Olanzapine Glenmark 5 mg tablets Olanzapine
Maltese: Olanzapine Glenmark 5 mg pilloli Olanzapine
English: You should swallow the Olanzapine Glenmark tablets whole, with water.
Maltese: Għandek tibla' l-pilloli Olanzapine Glenmark sħaħ bl-ilma.
English: SE-11276 Stockholm Sweden
Maltese: SE-11276 Stockholm
English: The specific activity of ReFacto AF is 7,600-13,800 IU/mg protein.
Maltese: L-attività speċifika ta' ReFacto AF hi ta' 7,600-13,800 IU/mg proteina.
English: PK parameter
Maltese: Parametru PK
English: Immune Tolerance Induction
Maltese: Induzzjoni ta' Tolleranza Immuni
English: Aged <6 years Aged 6 to <12 years Cmax, IU/mLb
Maltese: Età ta' <6 snin Età ta' 6 sa <12-il sena Cmax, IU/mL
English: AUCinf, IU∙h/mLb t½, hb
Maltese: AUCinf, IU·h/mL t½, h
English: Remove the tourniquet.
Maltese: Neħħi t-turnikett.
English: PUPs <6 years
Maltese: PUPs <6 snin
English: Uncommon ≥ 1/1,000 to
Maltese: Mhux komuni ≥ 1/1,000 sa
English: Angina pectoris; tachycardia; palpitations
Maltese: Anġina pectoris; takikardija;palpitazzjonijiet
English: Pfizer Tél: +33 (0)1 58 07 34 40
Maltese: Tél: +33 (0)1 58 07 34 40
English: Pack size of 1.
Maltese: Daqs ta' pakkett ta' 1.
English: Date of first authorisation: 13 April 1999 Date of latest renewal: 15 April 2014
Maltese: Data tal-ewwel awtorizzazzjoni: 13 ta' April 1999 Data tal-aħħar tiġdid: 15 ta' April 2014
English: It is important that the recommendations in section 6.3 be followed closely.
Maltese: Huwa importanti li r-rakkomandazzjonijiet fis-sezzjoni 6.3 jiġu segwiti mill-qrib.
English: Pfizer Limited Tel: +44 (0)1304 616161
Maltese: United Kingdom Pfizer Limited Tel: +44 (0)1304 616161
English: Pfizer PFE, spol.
Maltese: Česká Republika Pfizer PFE, spol.
English: CL, mL/h/kgb
Maltese: CL, mL/h/kg Vss, mL/kg a
English: PTPs <6 years
Maltese: PTPs <6 snin
English: FVIII inhibition (PUPs)*
Maltese: Inibizzjoni ta' FVIII (PUPs)
English: SD Median
Maltese: SD Medjan
English: 1 gauze
Maltese: 1 stikka
English: Repeat every 12-24 hours.
Maltese: Irrepeti kull 12-24 siegħa.
English: FVIII inhibition (PTPs)*
Maltese: Inibizzjoni ta' FVIII (PTPs)
English: PTPs 6 to <12 years
Maltese: PTPs 6 sa <12il sena
English: 1 plunger rod 1 sterile infusion set 2 alcohol swabs 1 plaster
Maltese: 1 lasta tal-planġer 1 sett sterilizzat għall-infużjoni 2 swabs bl-alkoħol 1 stikka
English: Frequencies have been evaluated according to the following convention: very common (≥ 1/10); common (≥ 1/100 to < 1/10) and uncommon (≥ 1/1,000 to < 1/100).
Maltese: Il-frekwenzi ġew evalwati skont il-konvenzjoni li ġejja: komuni ħafna (≥ 1/10); komuni (≥ 1/100 sa < 1/10) u mhux komuni (≥ 1/1,000 sa < 1/100).
English: Česká Republika
Maltese: Slovenská republika
English: The ratios of geometric least-square means of month 6-to-baseline pharmacokinetic were 107%, 100% and 104% for recovery, AUCt and AUC∞, respectively.
Maltese: Il-proporzjonijiet tal-medji least-square ġeometriċi tas-6 xahar mal-linja bażi tal-farmakokinetika kienu ta' 107%, 100% u 104% għall-irkupru, AUCt u AUC, rispettivament.
English: Pfizer, podružnica za svetovanje s področja farmacevtske dejavnosti, Ljubljana Tel: + 386 (0) 1 52 11 400
Maltese: Pfizer Luxembourg SARL Pfizer, podružnica za svetovanje s področja farmacevtske dejavnosti, Ljubljana Tel: + 386 (0) 1 52 11 400
English: It is a glycoprotein with an approximate molecular mass of 170,000 Da consisting of 1438 amino acids.
Maltese: Hu glikoproteina b'massa molekulari ta' bejn wieħed u ieħor ta' 170,000 Da magħmula minn 1438 aċidi amminiċi.
English: Tel: +420 283 004 111
Maltese: s r.o. Tel: +420 283 004 111
English: Store and transport refrigerated (2°C - 8°C).
Maltese: Ħażna u transport fil-friġġ (2°C - 8°C).
English: Solvent for ReFacto AF
Maltese: Solvent għal ReFacto AF
English: Meana ± SD
Maltese: Medja a  SD
English: • muscular pain
Maltese: • uġigħ fil-muskoli
English: Moroctocog alfa (recombinant human coagulation factor VIII)
Maltese: Moroctocog alfa (fattur VIII tal-koagulazzjoni rikombinanti uman)
English: Dose by weight (IU/kg) per prophylaxis infusion a median (min, max)
Maltese: Doża skont il-piż (IU/kg) għal kull infużjoni ta' profilassi a medjan (min, mass)
English: Pfizer Luxembourg SARL filiāle Latvijā
Maltese: Pfizer Luxembourg SARL filialas Lietuvoje Tel.
English: • rash, hives, wheals, generalised itching
Maltese: • raxx, urtikarja, wheals, u ħakk ġeneralizzat
English: The table presented below is according to the MedDRA system organ classification (SOC and Preferred Term Level).
Maltese: It-tabella ppreżentata hawn taħt hija skont is-sistema tal-klassifika tal-organi MedDRA (SOC u Livell tat-Terminu Ppreferut).
English: ReFacto AF contains the active substance moroctocog alfa, human coagulation factor VIII.
Maltese: ReFacto AF fih is-sustanza attiva moroctocog alfa, fattur VIII tal-koagulazzjoni umana.
English: The ratios of geometric least-square means of ReFacto AF-to-ReFacto were 100.6%, 99.5% and 98.1% for recovery, AUCt and AUC∞ (area under the plasma concentration curve from time zero to infinity), respectively.
Maltese: 6%, 99.5% u 98.1% għall-irkupru, AUCt u AUC (żona taħt il-kurva tal-konċentrazzjoni talplażma minn żero sal-infinità), rispettivament.
English: Contains 4 ml of sodium chloride 9 mg/ml (0.9%) solution for injection
Maltese: Fih 4 ml ta' 9 mg/ml (0.9%) sodium chloride għal soluzzjoni għall-injezzjoni
English: Ελλάδα PFIZER ΕΛΛΑΣ Α.Ε.Τηλ: +30 210 678
Maltese: PFIZER ΕΛΛΑΣ Α.Ε. Τηλ: +30 210 678 5800
English: The corresponding 90% confidence intervals about the ratios of month 6-to-baseline for the above pharmacokinetic parameters were within the equivalence window of 80% to 125%.
Maltese: L-intervalli tal-kunfidenza korrispondenti ta' 90% dwar il-proporzjonijiet tas-6 xahar mal-linja bażi għall-parametri farmakokinetiċi t'hawn fuq kienu fl-equivalence window ta' 80% sa 125%.
English: Population pharmacokinetic modeling using data from 44 PUPs led to a mean estimated half-life of 8.0 ± 2.2 hours.
Maltese: L-immudellar farmakokinetiku tal-popolazzjoni bl-użu ta' dejta minn 44 PUPs wassal għal medja ta' stima ta' halflife ta' 8.0 ± 2.2 sigħat.
English: Haemorrhage; haematoma
Maltese: Emorraġija; ematoma
English: Urticaria; rash; pruritus Hyperhidrosis
Maltese: Urtikarja; raxx; ħakk Iperidrosi
English: In PUPs, pharmacokinetic parameters of ReFacto were evaluated using the chromogenic assay.
Maltese: Fil-PUPs, il-parametri farmakokinetiċi ta' ReFacto kienu evalwati bl-użu ta' analiżi kromoġenika.
English: • severe allergic reaction
Maltese: • reazzjoni allerġika severa
English: Κύπρος PFIZER ΕΛΛΑΣ Α.Ε.
Maltese: PFIZER ΕΛΛΑΣ Α.Ε. (CYPRUS BRANCH)
English: - The active substance is moroctocog alfa (recombinant coagulation factor VIII).
Maltese: - Is-sustanza attiva hi moroctocog alfa (fattur VIII tal-koagulazzjoni rikombinanti).
English: CL (mL/h·kg)
Maltese: CL (mL/siegħa:
English: The corresponding 90% confidence intervals about the ratios of ReFacto AF to ReFacto geometric means were within the bioequivalence window of 80% to 125%, demonstrating bioequivalence of ReFacto AF to ReFacto.
Maltese: L-intervalli tal-kunfidenza korrispondenti ta' 90% dwar il-proporzjonijiet ta' ReFacto AF mal-medji ġeometriċi ta' ReFacto kienu fil-bioequivalence window ta' 80% sa 125%, li juru bijoekwivalenza ta' ReFacto AF ma' ReFacto.
English: België /Belgique / Belgien
Maltese: België /Belgique / Belgien Pfizer S.A./N.V.
English: ReFacto AF contains 1.23 mmol (or 29 mg) sodium per vial of reconstituted powder.
Maltese: ReFacto AF fih 1.23 mmol (jew 29 mg) ta' sodium f'kull kunjett ta' trab rikostitwit.
English: The data in the table below relates to PUP and PTP data from ReFacto AF studies in patients <12 years.
Maltese: Id-dejta fit-tabella t'hawn taħt għandha x'taqsam mad-dejta minn PUP u PTP minn studji dwar ReFacto AF f'pazjenti li kellhom <12-il sena.
English: ReFacto AF is given by injection into a vein lasting several minutes.
Maltese: Il-prodott ReFacto AF rikostitwit għandu jiġi injettat ġol-vina għal diversi minuti.
English: A solvent [sodium chloride 9 mg/ml (0.9%) solution for injection] is included within the ReFacto AF pre-filled syringe for reconstituting moroctocog alfa.
Maltese: Soluzzjoni solvent [sodium chloride 9 mg/ml (0.9%) għal injezzjoni] hija nkluża f'ReFacto AF siringa mimlija għal-lest għar-rikostituzzjoni ta' moroctocog alfa.
English: No interactions of recombinant coagulation factor VIII products with other medicinal products have been reported.
Maltese: Ma ġiet irrappurtata l-ebda interazzjoni tal-prodotti ta' fattur VIII tal-koagulazzjoni rikombinanti ma' prodotti mediċinali oħra.
English: • increased liver enzymes, increased bilirubin
Maltese: • żieda fl-enzimi tal-fwied, żieda fil-bilirubina
English: t1/2 (h)
Maltese: NUMRU(I)
English: Clinical studies did not include subjects aged 65 and over.
Maltese: L-istudji kliniċi ma inkludewx individwi ta' 65 sena u iktar.
English: Out of 6 patients who developed low titre inhibitors but did not receive ITI, 5 had similar titre decreases.
Maltese: Minn 6 pazjenti li żviluppaw inibituri ta' titres baxxi iżda li ma ngħatawx ITI, 5 kellhom tnaqqis simili fit-titres.
English: ReFacto AF contains B-domain deleted recombinant coagulation factor VIII (moroctocog alfa).
Maltese: ReFacto AF fih il-fattur tal-koagulazzjoni rikombinanti VIII (moroctocog alfa) bid-dominju B imħassar.
English: Hypersensitivity or allergic reactions (which may include angioedema, burning and stinging at the infusion site, chills, flushing, generalised urticaria, headache, hives, hypotension, lethargy, nausea, restlessness, tachycardia, tightness of the chest, tingling, vomiting, wheezing) have been observed infrequently for ReFacto, and may in some cases progress to severe anaphylaxis including shock (see section 4.4).
Maltese: Sensittività eċċessiva jew reazzjonijiet allerġiċi (li jistgħu jinkludu anġjoedema, ħruq u tingiż fis-sit tal-infużjoni, tertir ta' bard, fwawar, urtikarja ġeneralizzata, uġigħ ta' ras, ħorriqija, pressjoni baxxa, letarġija, dardir, nuqqas ta' sabar, takikardija, għafis fis-sider, tnemnim, rimettar, tħarħir) ġew osservati b'mod mhux frekwenti għal ReFacto u jistgħu f'xi każijiet jaggravaw għal anafilassi severa, li tinkludi xokk (ara sezzjoni 4.4).
English: In a study of ReFacto, twenty of 113 (18%) previously treated patients (PTPs) had an increase in anti-CHO antibody titre, without any apparent clinical effect.
Maltese: Fi studju dwar ReFacto, għoxrin minn 113 (18%)-il pazjent li ġew ikkurati qabel (PTPs) kellhom żieda fit-titer tal-antikorpi anti-CHO, mingħajr kwalunkwe effett kliniku apparenti.
English: For reconstitution instructions prior to administration, see section 6.6.
Maltese: Għal-lista kompluta ta' eċċipjenti, ara sezzjoni 6.1.
English: Pharmacotherapeutic group: antihaemorrhagics, blood coagulation factor VIII; ATC code: B02BD02.
Maltese: Kategorija farmakoterapewtika: mediċini kontra l-emoraġġija, fattur VIII tal-koagulazzjoni tad-demm, Kodiċi ATC:
English: ReFacto AF has functional characteristics comparable to those of endogenous factor VIII.
Maltese: ReFacto AF għandu karatteristiċi funzjonali komparabbli ma' dawk ta' fattur VIII endoġeniku.
English: Total ABR all subjects b median (min, max)
Maltese: ABR totali għall-individwi kollha medjan (min, mass)
English: Each pre-filled syringe of ReFacto AF contains nominally 250, 500, 1000, 2000, or 3000 IU of moroctocog alfa.
Maltese: Kull siringa mimlija għal-lest ta' ReFacto AF nominalment fiha 250, 500, 1000, 2000 jew 3000 IU ta' moroctocog alfa.
English: 1 vented sterile cap
Maltese: 1 kappa sterili b'vent
English: Other medicines and ReFacto AF
Maltese: Mediċini oħra u ReFacto AF
English: Diarrhoea; vomiting; abdominal pain; nausea
Maltese: Dijarea; rimettar; uġigħ addominali; nawseja
English: - The other ingredients are sucrose, calcium chloride dihydrate, L-histidine, polysorbate 80 and sodium chloride.
Maltese: - Is-sustanzi l-oħra huma sucrose, calcium chloride dihydrate, L-histidine, polysorbate 80 u sodium chloride.
English: Abbreviations: ABR = annualised bleeding rate
Maltese: ABR = rata ta' fsada anwalizzata
English: Multiple ReFacto AF in Pre-filled Syringe Reconstitution to a 10 cc or Larger Luer Lock Syringe (10 cc or larger luer lock syringes not provided)
Maltese: ReFacto AF multipla fir-Rikostituzzjoni ta' Siringa mimlija għal-lest għal Siringa Luer Lock 10 cc jew Ikbar (Siringi luer lock 10 cc jew ikbar mhux ipprovduti)
English: MRT (h) recovery (IU/dl increase in FVIII:C per IU/kg FVIII given) Abbreviations: AUCt = area under the plasma concentration-time curve from zero to the last measurable concentration; t½ = half-life; CL = clearance; FVIII:C = FVIII activity; MRT = mean residence time
Maltese: AUCt = żona taħt il-kurva konċentrazzjoni-ħin minn żero sal-aħħar konċentrazzjoni li tista' titkejjel; t½ = half-life; CL = tneħħija; FVIII:C = attività FVIII;
English: Aspartate aminotransferase increased; alanine aminotransferase increased; blood bilirubin increased; blood creatinine phosphokinase increased * Frequency is based on studies with all FVIII products which included patients with severe haemophilia A. PTPs = previously-treated patients, PUPs = previously-untreated patients
Maltese: Żieda f'aspartate aminotransferase; żieda f'alanine aminotransferase; żieda fil-bilirubina fid-demm, żieda fil-creatinine phosphokinase fid-demm
English: ReFacto AF is administered by intravenous (IV) infusion after reconstitution of the powder with the solvent (0.9% sodium chloride).
Maltese: ReFacto AF jingħata permezz ta' infużjoni fil-vina (IV) wara r-rikostituzzjoni tat-trab mas-solvent (0.9% sodium chloride).
English: Ελλάδα PFIZER ΕΛΛΑΣ Α.Ε
Maltese: Metodu ta' kif għandu jingħata
English: The product, when reconstituted, contains polysorbate-80, which is known to increase the rate of di-(2-ethylhexyl) phthalate (DEHP) extraction from polyvinyl chloride (PVC).
Maltese: Il-prodott, meta rikostitwit, fih polysorbate-80, li huwa magħruf li jżid ir-rata tal-estrazzjoni ta' di-(2-ethylhexyl) phthalate (DEHP) minn polyvinyl chloride (PVC).
English: In case of severe allergic reactions, alternative therapy must be considered.
Maltese: F'każ ta' reazzjonijiet allerġiċi serji, terapija alternattiva trid tiġi kkunsidrata.
English: Required units (IU) = body weight (kg) x desired factor VIII rise (% or IU/dl) x 0.5 (IU/kg per IU/dl), where 0.5 IU/kg per IU/dl represents the reciprocal of the recovery generally observed following infusions of factor VIII.
Maltese: Unitajiet meħtieġa (IU) = il-piż tal-ġisem (kg) x kemm irid jogħla l-fattur VIII (% jew IU/dl) x 0.5
English: AUCt (IU·h/mL)
Maltese: AUCt (IU:siegħa/mL) t1/2 (sigħat)
English: The formation of neutralising antibodies (inhibitors) to factor VIII is a known complication in the management of individuals with haemophilia A. These inhibitors are usually IgG immunoglobulins directed against the factor VIII pro-coagulant activity, which are quantified in Bethesda Units (BU) per mL of plasma using the modified assay.
Maltese: IgG diretti lejn l-attività prokoagulanti tal-fattur VIII, li jiġu kwantifikati f'Unitajiet Bethesda (BU) għal kull ml ta' plażma billi tintuża l-analiżi modifikata (modified assay).
English: ReFacto AF contains sodium
Maltese: ReFacto AF fih is-sodium
English: The contents of the pack are: - one pre-filled syringe containing moroctocog alfa 250, 500, 1000, 2000, or 3000 IU powder and solvent, 4 ml sterile sodium chloride 9 mg/ml (0.9 %) solution for injection for reconstitution - one plunger rod - one protective blue vented sterile cap - one sterile infusion set - two alcohol swabs - one plaster - one gauze pad
Maltese: Il-pakkett ikun fih: - siringa waħda mimlija għal-lest li fiha moroctocog alfa 250, 500, 1000,2000 jew 3000 IU trab u solvent, 4 ml ta' soluzzjoni sterili ta' 9 mg/ml (0.9 %) sodium chloride għall-injezzjoni għar rikostituzzjoni - lasta tal-planġer waħda - kappa sterili blue-vented ta' protezzjoni waħda - sett sterili wieħed ta' l-infużjoni - żewġ swabs bl-alkoħol - stikka waħda - pad wieħed tal-garża
English: Recovery, IU/dl per IU/kg
Maltese: IU/dl f'kull IU/kg
English: Administration (Intravenous Infusion)
Maltese: Għoti (Infużjoni fil-vina)
English: • hives, rash, itching
Maltese: • ħorriqija, raxx, ħakk
English: 1 vial with 250 IU moroctocog alfa 1 vial with 500 IU moroctocog alfa 1 vial with 1000 IU moroctocog alfa 1 vial with 2000 IU moroctocog alfa
Maltese: IU ta' moroctocog alfa 1 kunjett b'1000 IU ta' moroctocog alfa 1 kunjett b'2000
English: ReFacto AF is administered by intravenous infusion over several minutes after reconstitution of the lyophilised powder for injection with sodium chloride 9 mg/mL (0.9%) solution for injection (provided).
Maltese: ReFacto AF jingħata b'infużjoni ġol-vina fuq perjodu ta' diversi minuti wara li t-trab lajofilizzat għallinjezzjoni jiġi rikostitwit f'9 mg/mL (0.9%) ta' sodium chloride, soluzzjoni għall-injezzjoni
English: ReFacto AF is administered by intravenous (IV) infusion after reconstitution of the lyophilised powder for injection with the supplied solvent [sodium chloride 9 mg/ml (0.9%) solution] syringe.
Maltese: ReFacto AF jingħata ġol-vina (IV) permezz ta' infużjoni wara r-rikostituzzjoni tat-trab lajofilizzat għall-injezzjoni bis-solvent ipprovdut fis-siringa [soluzzjoni ta' 9 mg/ml (0.9%) sodium chloride].
English: Moroctocog alfa is a glycoprotein with 1438 amino acids with a sequence that is comparable to the 90 + 80 kDa form of factor VIII (i.e. B-domain deleted) and similar post-translational modifications to those of the plasma-derived molecule.
Maltese: ** Fattur VIII tal-koagulazzjoni umana, magħmul minn teknoloġija tad-DNA rikombinanti f'ċelluli tal-ovarju tal-ħamster Ċiniż (CHO). Moroctocog alfa hu glikoproteina b'1438 aċidi amminiċi b'sekwenza ta' aċidi amminiċi li hi komparabbli mal-għamla ta' 90+ 80 kDa tal-fattur VIII (i.e. Bdomain mħassar), u modifikazzjoniet ta' wara l-bidla, simili għal molekula derivata mill-plażma.
English: Minor surgery including tooth extraction
Maltese: Operazzjoni minuri inkluż qlugħ ta' snien
English: Pyrexia
Maltese: Pfizer
English: ReFacto AF does not contain von Willebrand factor, and hence is not indicated in von Willebrand's disease.
Maltese: ReFacto AF m'għandux il-fattur von Willebrand u għalhekk m'huwiex użat għall-marda von Willebrand.
English: Pfizer bv Tel: +31 (0)10 406 43 01
Maltese: Tel: +31 (0)10 406 43 01
English: Of note, annualised bleeding rate (ABR) is not comparable between different factor concentrates and between different clinical studies.
Maltese: Ta' min jinnota, ir-rata ta' fsada annwalizzata (ABR, annualized bleeding rate) ma kinitx komparabbli bejn il-konċentrati tal-fattur differenti u bejn l-istudji kliniċi differenti.
English: Store and transport at 2°C - 8°C.
Maltese: Aħżen u ġorr f'temperatura ta' bejn 2C - 8C
English: Detailed information on this medicine is available on European Medicines Agency website: http://www.ema.europa.eu/.
Maltese: Informazzjoni dettaljata dwar din il-mediċina tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea għallMediċini http://www.ema.europa.eu/.
English: In the case of major surgical interventions in particular, precise monitoring of the substitution therapy by means of coagulation analysis (plasma factor VIII activity) is indispensable.
Maltese: Fil-każ ta' interventi kirurġiċi maġġuri b'mod partikolari, monitoraġġ preċiż tat-terapija ta' sostituzzjoni permezz ta' analiżi tal-koagulazzjoni (attività tal-fattur VIII fil-plasma) huwa indispensabbli.
English: The reconstituted solution may be stored at room temperature for up to 3 hours.
Maltese: Is-soluzzjoni rikostitwita tista' tinħażen f'temperatura tal-kamra sa 3 sigħat.
English: Neuropathy peripheral; somnolence; dysgeusia
Maltese: Newropatija periferali, ngħas, indeboliment fis-sens tattogħma
English: Pfizer Innovations AB Tel: + 46 (0)8 550 520 00
Maltese: Tel: + 46 (0)8 550 520 00
English: In a study of 37 paediatric PTPs, the pharmacokinetic parameters of ReFacto AF observed after a 50 IU/kg dose are shown in the table below.
Maltese: Fi studju fuq 37 PTP pedjatriku, il-parametri farmakokinetiċi ta' ReFacto AF osservati wara doża ta' 50
English: Inhibitor development
Maltese: IL-PRODOTT MEDIĊINALI
English: Antibody test positive; Anti-factor VIII antibody test positive
Maltese: Test għall-antikorpi pożittiv;
English: Very rarely, development of antibodies to hamster protein has been observed, but there were no clinical sequelae.
Maltese: B'mod rari ħafna, ġie osservat liżvilupp ta' antikorpi għall-proteini tal-ħamsters, iżda ma kienx hemm konsegwenzi kliniċi.
English: Pharmacokinetic properties of ReFacto, derived from a cross-over study of ReFacto and a plasmaderived FVIII concentrate, using the chromogenic substrate assay (see section 4.2), in 18 previously treated patients are listed in the table below.
Maltese: Il-proprjetajiet farmakokinetiċi ta' ReFacto, miskuba minn studju cross-over ta' ReFacto u ta' konċentrat FVIII derivat mill-plażma, bl-użu tal-assaġġ ta' substrat kromoġeniku (ara sezzjoni 4.2), fi 18-il pazjent li kienu kkurati qabel, huma elenkati fit-tabella hawn taħt.
English: Mean ± SD FVIII Pharmacokinetic Parameters after Single 50 IU/kg Dose in Paediatric PTPs
Maltese: Medja tal- SD tal-Parametri Farmakokinetiċi ta' FVIII wara Doża Waħda ta' 50