FrancophonIA/ELRC3.0 huggingface dataset:
English: In a ReFacto AF study of 19 PUPs, the recovery at the beginning of the study in the 17 children aged 28 days to less than 2 years was 1.32 ± 0.65 IU/dl per IU/kg and in the 2 children aged 2 to <6 years were 1.7 and 1.8 IU/dl per IU/kg.
Maltese: IU/dl kull IU/kg, u fiż-2 itfal li kellhom minn sentejn sa <6 snin kien ta' 1.7 u 1.8 IU/dl kull IU/kg.
English: The table lists adverse reactions reported in the clinical trials with ReFacto or ReFacto AF.
Maltese: It-tabella telenka rreazzjonijiet avversi rrapportati fil-provi kliniċi b'ReFacto jew b'ReFacto AF.
English: The manufacturing process for ReFacto was modified to eliminate any exogenous human- or animal-derived protein in the cell culture process, purification, or final formulation; and at the same time the invented name was changed to ReFacto AF.
Maltese: Il-proċess tal-manifattura għal ReFacto ġie modifikat biex tiġi eliminata kwalunkwe proteina esoġenika umana jew li hi derivata mill-annimali fil-proċess tal-koltura taċ-ċelluli, purifikazzjoni, jew il-formulazzjoni finali; u fl-istess ħin l-isem inventat inbidel għal ReFacto AF.
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu/.
Maltese: Informazzjoni dettaljata dwar dan il-prodott mediċinali tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea għall-Mediċini http://www.ema.europa.eu/.
English: If a central venous access device (CVAD) is required, risk of CVAD-related complications including local infections, bacteraemia and catheter site thrombosis should be considered (see section 4.8).
Maltese: Jekk ikun meħtieġ tagħmir ta' aċċess ċentrali venuż (CVAD- central venous access device), ir-riskju ta' kumplikazzjonijiet relatati ma' CVAD, li jinkludu infezzjonijiet lokali, batteremija u trombożi fissit tal-kateter, għandhom jiġu kkunsidrati (ara sezzjoni 4.8).
English: Abbreviations: Cmax = maximum observed plasma concentration; CV = coefficient of variation; AUCinf = area under the plasma concentration-time profile from time zero extrapolated to infinite time; t½ = terminal half-life; CL = clearance; Vss = steady-state volume of distribution.
Maltese: Cmax = konċentrazzjoni massima fil-plażma osservata; CV = koeffiċjent ta' varjazzjoni; AUCinf = erja taħt il-profil tal-konċentrazzjoni tal-plażma maż-żmien minn żmien żero estrapolat għal żmien infinit; t½ = half-life terminali; CL = tneħħija; Vss = volum ta' distribuzzjoni fl-istat fiss.
English: See the package leaflet for further information Sucrose, calcium chloride dihydrate, L-histidine, polysorbate 80, sodium chloride
Maltese: Ara l-fuljett ta' tagħrif għal aktar informazzjoni Sucrose, calcium chloride dihydrate, L-histidine, polysorbate 80, sodium chloride
English: Pfizer Luxembourg SARL filialas Lietuvoje Tel. +3705 2514000
Maltese: Pfizer Luxembourg SARL filiāle Latvijā Tel: +371 670 35 775
English: Frequency of doses (hours)/ Duration of therapy (days)
Maltese: Il-frekwenza tad-dożi (sigħat)/Id-dewmien tat-terapija (ġranet)
English: Activated factor VIII acts as a cofactor for activated factor IX, accelerating the conversion of factor X to activated factor X. Activated factor X converts prothrombin into thrombin.
Maltese: Il-fattur attivat VIII jaħdem bħala kofattur attiv għal fattur attiv IX u jaċċelera l-konverżjoni minn fattur X għal fattur X attivat.
English: ReFacto AF is used for the treatment and prevention of bleeding (prophylaxis) in adults and children of all ages (including newborns) with haemophilia A.
Maltese: ReFacto AF jintuża għall-kura u l-prevenzjoni ta' emorraġiji (profilassi) fl-adulti u t-tfal ta' kull età (li jinkludu trabi tat-twelid) b'emolfilja A.
English: 1 pre-filled syringe: 500 IU moroctocog alfa (approx. 125 IU/ml after reconstitution) 1 pre-filled syringe: 1000 IU moroctocog alfa (approx. 250 IU/ml after reconstitution) 1 pre-filled syringe: 2000 IU moroctocog alfa (approx. 500 IU/ml after reconstitution) 1 pre-filled syringe: 3000 IU moroctocog alfa (approx. 750 IU/ml after reconstitution)
Maltese: IU ta' moroctocog alfa kull ml rispettivament (ibbażat fuq il-qawwa ta' moroctocog alfa, i.e. 250, 500, 1000, 2000 jew 3000 IU), ta' moroctocog alfa f'kull 1 ml tas-soluzzjoni ppreparata għall-injezzjoni.
English: ReFacto AF 250 IU, 500 IU, 1000 IU, 2000 IU powder and solvent for solution for injection 250 IU, 500 IU, 1000 IU or 2000 IU powder in a 10 mL vial (type 1 glass) with a stopper (butyl) and a flip-off seal (aluminum) and 4 mL of solvent in a pre-filled syringe (type 1 glass) with a plunger stopper (butyl), a tip-cap (butyl) and a sterile vial adapter reconstitution device, a sterile infusion set, alcohol swabs, a plaster and a gauze pad.
Maltese: IU trab f'kunjett ta' 10 mL (ħġieġ ta' tip 1) b'tapp (butyl) u siġill li tiftħu b'daqqa ta' saba' (aluminju) u 4 mL ta' solvent f'siringa mimlija għal-lest (ħġieġ ta' tip 1) bi planġer-tapp (butyl), għatu tat-tarf (butyl) u adapter sterili tal-kunjett tat-tagħmir tar-rikostituzzjoni, sett sterili ta' l-infużjoni, biċċiet bl-alkoħol, stikka u pad tal-garża.
English: Due to the difference in methods used to assign product potency of XYNTHA and ReFacto AF, 1 IU of the XYNTHA product (one-stage assay calibrated) is approximately equivalent to 1.38 IU of the ReFacto AF product (chromogenic assay calibrated).
Maltese: Minħabba d-differenza fil-metodi użati biex jassenjaw il-qawwa tal-prodott ta' XYNTHA u ReFacto AF, 1 IU tal-prodott XYNTHA (assaġġ ikkalibrat ta' stadju wieħed) hi ekwivalenti għal madwar 1.38 IU tal-prodott ReFacto AF (assaġġ ikkalibrat kromoġeniku).
English: Reconstitution:
Maltese: Rikostituzzjoni:
English: These patients (n=59; median age 10 ± 8.3 months) had a mean recovery at Week 0 of 1.5 ± 0.6 IU/dl per IU/kg (range 0.2 to 2.8 IU/dl per IU/kg) which was lower than that obtained in PTPs treated with ReFacto at Week 0 with a mean recovery of 2.4 ± 0.4 IU/dl per IU/kg (range 1.1 to 3.8 IU/dl per IU/kg).
Maltese: Dawn il-pazjenti (n=59; età medjana 10 ± 8.3) kellhom medja ta' l-irkuprar f'Ġimgħa 0 ta' 1.5 ± 0.6
English: - After reconstitution with the supplied solvent [sodium chloride 9 mg/ml (0.9%) solution], each vial contains 62.5, 125, 250, or 500 IU, respectively (based on the strength of moroctocog alfa,
Maltese: - Wara rikostituzzjoni bis-solvent fornut [soluzzjoni ta' 9 mg/ml (0.9%) sodium chloride], kull kunjett fih 62.5, 125, 250, jew 500
English: For children not previously treated with factor VIII medicines, inhibitor antibodies (see section 2) may form very commonly (more than 1 in 10 patients); however patients who have received previous treatment with factor VIII (more than 150 days of treatment) the risk is uncommon (less than 1 in 100 patients).
Maltese: Għal tfal li ma kinux ikkurati qabel b'mediċini li fihom Fattur VIII, antikorpi inibituri (ara sezzjoni 2) jistgħu jiffurmaw b'mod komuni ħafna (aktar minn pazjent 1 minn kull 10); madankollu, pazjenti li jkunu rċivew kura b'Fattur VIII fil-passat (aktar minn 150 jum ta' kura), ir-riskju mhux komuni (inqas minn 1 minn kull 100 pazjent).
English: Package leaflet: Information for the user
Maltese: Kontenut tal-pakkett u informazzjoni oħra
English: In the same study, in which the drug potency of ReFacto AF and a full-length recombinant factor VIII (FLrFVIII) comparator, and the FVIII activity measured in patient plasma samples were all determined using the same one-stage clotting assay at a central laboratory, ReFacto AF was shown to be pharmacokinetically equivalent to FLrFVIII in 30 previously treated patients (≥ 12 years) using the standard bioequivalence approach.
Maltese: Fl-istess studju, li fih il-qawwa ta' ReFacto AF u komparatur (FLrFVIII) ta' fattur rikombinanti VIII full-length, u l-attività FVIII imkejla f'kampjuni tal-plażma tal-pazjenti kienu kollha stabbiliti bl-użu tal-istess assaġġ tat-tagħqid ta' demm bi stadju wieħed f'laboratorju ċentrali, intwera li ReFacto AF kien farmakokinetikament ekwivalenti għal FLrFVIII fi 30 pazjent li kienu kkurati qabel (≥ 12-il sena) bl-użu tal-bijoekwivalenza standard.
English: Hypotension; thrombophlebitis; flushing
Maltese: Pressjoni baxxa; tromboflebite; fwawar
English: ReFacto AF 3000 IU powder and solvent for solution for injection in pre-filled syringe Each pre-filled syringe contains nominally 3000 IU* moroctocog alfa**.
Maltese: IU trab u solvent għal soluzzjoni għall-injezzjoni f'siringa mimlija għal-lest Kull siringa mimlija għal-lest nominalment fiha 3000 IU* moroctocog alfa**.
English: As part of the pivotal trial with ReFacto in PUPs, ITI data from 25 patients were reviewed (15 with high titres, 10 with low titres).
Maltese: Bħala parti mill-prova pivotali b'ReFacto f'PUPs, id-dejta dwar ITI minn 25 pazjent ġiet riveduta (15 b'titers għoljin, 10 b'titers baxxi).
English: Of these 25 patients, 20 had a decrease in inhibitor titres to < 0.6 BU/mL, of whom initially 11 of 15 had high titres (≥ 5 BU/mL) and 9 of 10 had low titres.
Maltese: Minn dawn il-25 pazjent, 20 kellhom tnaqqis fit-titres tal-inibituri sa < 0.6
English: Individual patients may vary in their response to factor VIII, demonstrating different half-lives and recoveries.
Maltese: Il-pazjenti individwali jista' jkollhom rispons differenti għall-fattur VIII, u dan juri half-lives u rkupri differenti.
English: 250 IU, 500 IU, 1000 IU, 2000 IU or 3000 IU lyophilised powder in top chamber and 4 mL of solvent in bottom chamber of the pre-filled syringe (type 1 glass) with butyl rubber plungers and closure, one plunger rod for assembly, a polypropylene vented sterile cap, a sterile infusion set, alcohol swabs, a plaster and a gauze pad.
Maltese: IU jew 3000 IU trab lijofilizzat fil-kompartiment ta' fuq u 4 mL tassolvent fil-kompartiment t'isfel tas-siringa mimlija għal-lest (ħġieġ tip 1) bi planġers u għeluq talgomma butyl, virga planġer waħda għall-assemblaġġ, kappa sterili b'vent tal-polypropylene, sett talinfużjoni sterili, swabs tal-alkoħol, stikka u garża.
English: - After reconstitution with the supplied solvent [sodium chloride 9 mg/ml (0.9%) solution], the prepared solution for injection contains either 62.5, 125, 250, 500 or 750 IU of moroctocog alfa per ml, respectively (based on the strength of moroctocog alfa, i.e., 250, 500, 1000, 2000, or 3000 IU).
Maltese: - Wara rikostituzzjoni bis-solvent fornut [soluzzjoni ta' 9 mg/ml (0.9%) sodium chloride], issoluzzjoni mħejjija għal injezzjoni fiha jew 62.5,125, 250, 500
English: • decreased appetite, diarrhoea, vomiting, stomach pain, nausea
Maltese: • tnaqqis fl-aptit, dijarrea, rimettar, uġigħ fl-istonku, dardir
English: * The potency (International Units) is determined using the European Pharmacopoeia chromogenic assay.
Maltese: * Il-qawwa (Unitajiet Internazzjonali) hi stabbilita fuq it-testijiet kromoġeniċi tal-Farmakopoea Ewropea.
English: Chemical and physical in-use stability has been demonstrated for 3 hours at temperatures up to 25°C.
Maltese: L-istabbiltà kimika u waqt l-użu kienet murija għal 3 sigħat f'temperaturi sa 25°C.
English: Surgery
Maltese: Sturdament
English: One IU of factor VIII activity is equivalent to the quantity of factor VIII in one mL of normal human plasma.
Maltese: IU waħda tal-attività tal-fattur VIII hi ekwivalenti għall-kwantità tal-fattur VIII f'ml wieħed tal-plażma normali tal-bniedem.
English: Additional safety experience in children has been accrued through studies that encompassed both previously treated (n=18 aged <6 years and n=19 aged 6 to <12 years) and previously untreated (n=23 aged <6 years) patients and which supports a safety profile similar with that observed in adult patients.
Maltese: Esperjenza addizzjonali dwar is-sigurtà fit-tfal ġiet akkumulata permezz ta' studji li kienu jinkludu kemm pazjenti li ġew ikkurati qabel (n=18 li kellhom <6 snin kif ukoll n=19 li kellhom minn 6 sa <12-il sena) u li ma ġewx ikkurati qabel (n=23 li kellhom <6 snin), u li jappoġġja profil tas-sigurtà li hu simili għal dak osservat f'pazjenti adulti.
English: ReFacto AF is administered by intravenous (IV) infusion after reconstitution.
Maltese: ReFacto AF jingħata ġol-vina (IV) permezz ta' infużjoni wara r-rikostituzzjoni.
English: Severe, sudden allergic (anaphylactic) reactions are uncommon (may affect up to 1 in 100 people).
Maltese: Reazzjonijet (anafilattiċi) allerġiċi severi, f'daqqa mhumiex komuni (jistgħu jaffettwaw sa persuna 1 minn kull 100).
English: Except in cases where inhibitors were detected, the mean recovery was stable over time (6 visits during a 2-year period) and individual values ranged from 0 (in presence of inhibitor) to 2.7 IU/dl per IU/kg.
Maltese: Ħlief f'każijiet fejn ġew osservati inibituri, il-medja talirkupru kienet stabbli matul iż-żmien (6 żjarat fuq perjodu ta' sentejn), u l-valuri individwali varjaw minn 0 (fil-preżenza ta' inibitur) sa 2.7 IU/dl kull IU/kg.
English: Patients should be informed of the early signs of hypersensitivity reactions including hives, generalised urticaria, tightness of the chest, wheezing, hypotension, and anaphylaxis.
Maltese: Il-pazjenti għandhom jiġu avżati dwar is-sinjali bikrija ta' reazzjonijiet ta' sensittività eċċessiva, li jinkludu ħorriqija, urtikarja ġeneralizzata, għafis tas-sider, tħarħir, pressjoni baxxa, u anafilassi.
English: Allergic type hypersensitivity reactions have been observed with ReFacto AF.
Maltese: Reazzjonijiet ta' sensittività eċċessiva ta' tip allerġiċi ġew osservati b'ReFacto AF.
English: b Subjects in the PUP study were not required to follow a regular continuous prophylaxis treatment; however, with the exception of one subject (with only on demand (OD) treatment) the majority of subjects took regular prophylaxis infusions.
Maltese: Individwi fl-istudju dwar PUP ma kinux meħtieġa li jsegwu kura ta' profilassi kontinwa regolari; madankollu, bl-eċċezzjoni ta' individwu wieħed (b'kura fil-pront (OD, on demand) biss), il-maġġoranza tal-individwi ħadu infużjonijiet ta' profilassi regolari.
English: ReFacto AF contains 1.23 mmol (or 29 mg) sodium per pre-filled syringe of reconstituted powder.
Maltese: Wara r-rikostituzzjoni, 1.23 mmol (29 mg) ta' sodium f'kull kunjett jew siringa mimlija għal-lest.
English: Reports of lack of effect, mainly in prophylaxis patients, have been received in the clinical trials and in the post-marketing setting for ReFacto.
Maltese: Rapporti ta' nuqqas ta' effett, primarjament f'pazjenti tal-profilassi, kienu riċevuti fil-provi kliniċi u flisfond ta' wara t-tqegħid fis-suq ta' ReFacto.
English: 1 pre-filled syringe: 250 IU moroctocog alfa (approx. 62.5 IU/ml after reconstitution).
Maltese: IU moroctocog alfa (madwar 250 IU/ml wara r-rikostituzzjoni).
English: The contents of the pack are: - one vial of moroctocog alfa 250, 500, 1000, or 2000 IU powder - one pre-filled syringe of solvent, 4 ml sterile sodium chloride 9 mg/ml (0.9 %) solution for injection for reconstitution, with one plunger rod - one sterile vial adapter reconstitution device - one sterile infusion set - two alcohol swabs - one plaster - one gauze pad
Maltese: IU - siringa mimlija għal-lest bis-solvent, 4 ml ta' soluzzjoni sterili ta' 9 mg/ml (0.9 %) sodium chloride għall-injezzjoni għar-rikostituzzjoni, b'lasta tal-planġer waħda - adapter sterili wieħed tal-kunjett tat-tagħmir għar-rikostituzzjoni - sett sterili wieħed ta' l-infużjoni - żewġ msiħ bl-alkoħol - stikka waħda - pad wieħed tal-garża
English: Suomi/Finland
Maltese: Suomi/Finland Pfizer Oy
English: In a cross-over pharmacokinetic study, the pharmacokinetic parameters for ReFacto AF were determined at baseline and followed up in 25 previously treated patients (≥ 12 years) after repeated administration of ReFacto AF for six months.
Maltese: Fi studju farmakokinetiku cross-over, il-parametri farmakokinetiċi għal ReFacto AF kienu stabbiliti fil-linja bażi u kienu segwiti f'25 pazjent li kienu kkurati qabel (≥12-il sena) wara l-għoti ripetut ta' ReFacto AF għal sitt xhur.
English: 1 vial: 250 IU moroctocog alfa (approx. 62.5 IU/ml after reconstitution).
Maltese: IU moroctocog alfa (madwar 250 IU/ml wara r-rikostituzzjoni)
English: The clinical relevance of inhibitor development will depend on the titre of the inhibitor, with low titre posing less of a risk of insufficient clinical response than high titre inhibitors.
Maltese: Ir-rilevanza klinika tal-iżvilupp tal-inibituri se tiddependi fuq it-titru tal-inibitur, b'titru baxx li jkollu inqas riskju ta' rispons kliniku insuffiċjenti milli minn inibituri b'titru għoli.
English: 1 pre-filled syringe with 4 ml solvent 1 vial adapter
Maltese: 1 siringa mimlija għal-lest (1000 IU trab fil-kompartiment ta' fuq u 4 ml solvent fil-kompartiment ta' isfel)
English: White to off-white cake/powder
Maltese: Solvent ċar u bla kulur
English: Pfizer Luxembourg SARL
Maltese: Pfizer bv
English: A solvent [sodium chloride 9 mg/ml (0.9%) solution for injection] is also supplied for reconstitution.
Maltese: Solvent [soluzzjoni għall-injezzjoni ta' 9 mg/ml (0.9%) sodium chloride] hu fornut ukoll għar-rikostituzzjoni.
English: Thrombin then converts fibrinogen into fibrin, and a clot is formed.
Maltese: Thrombin imbagħad tbiddel il-fibrinoġen f'fibrin u tifforma embolu tad-demm.
English: Factor VIII level required (% or IU/dl)
Maltese: Il-livell meħtieġ ta' Fattur VIII (% jew IU/dl)
English: Luxembourg/Luxemburg
Maltese: Luxembourg/Luxemburg Pfizer S.A.
English: Reconstituted ReFacto AF must not be administered in the same tubing or container with other medicinal products.
Maltese: ReFacto AF rikostitwit ma għandux jiġi amministrat fl-istess tubi jew kontenitur ma' prodotti mediċinali oħra.
English: Powder and solvent for solution for injection in pre-filled syringe White to off-white cake/powder in top chamber of the pre-filled syringe Clear, colourless solvent in bottom chamber of the pre-filled syringe
Maltese: Ħalli l-kunjetti ta' ReFacto AF imnixxef permezz ta' friża u siringa ppreparata bis-solvent jilħqu t-temperatura tal-kamra.
English: Data on immune tolerance induction (ITI) have been collected in patients with haemophilia A who had developed inhibitors to factor VIII.
Maltese: Dejta dwar induzzjoni ta' tolleranza immuni (ITI) inġabret f'pazjenti b'emofilja A li kienu żviluppaw inibituri għall-fattur VIII.
English: A separate 10 cc or larger luer lock syringe (not included in this kit) may be used to draw back the reconstituted contents of each syringe (see
Maltese: Tista' tintuża siringa luer lock separata ta' 10 cc jew ikbar (mhux inkluża f'dan il-kitt) biex tiġbed lura l-kontenuti rikostitwiti ta' kull siringa (Ara l-Istruzzjonijiet Addizzjonali)
English: ReFacto AF 250 ReFacto AF 500 ReFacto AF 1000 ReFacto AF 2000 ReFacto AF 3000
Maltese: Kull kunjett ta' ReFacto AF nominalment fih 250, 500, 1000, jew 2000
English: Allow the pre-filled syringe to reach room temperature.
Maltese: Ħalli s-siringa tilħaq it-temperatura tal-kamra.
English: The frequencies are based on all causality treatment emergent adverse events in pooled clinical trials with 765 subjects.
Maltese: Il-frekwenzi huma bbażati fuq l-episodji avversi emerġenti tal-kura tal-kawżalità kollha fi provi kliniċi miġburin f'765 individwu.
English: Safety of ReFacto AF was evaluated in studies that included both previously treated adults and previously treated children and adolescents (n=18, aged 12-16 years in a study and n=49, aged 7-16 years in a supporting study), with a tendency for higher frequencies of adverse reactions in children aged 7-16 years as compared to adults.
Maltese: Is-sigurtà ta' ReFacto AF kienet evalwata fi studji li kienu jinkludu kemm adulti kkurati qabel kif ukoll tfal u adolexxenti li kienu kkurati qabel (n=18, li kellhom 12-16-il sena fi studju, u n=49, li kellhom 7-16-il sena fi studju ta' appoġġ), b'tendenza għal frekwenzi ogħla ta' reazzjonijiet avversi fit-tfal ta' bejn 7 u 16-il sena meta mqabbel mal-adulti.
English: • inhibitor development for patients who have been previously treated with factor VIII products (less than 1 in 100 patients)
Maltese: • l-iżvilupp ta' inibitur għal pazjenti li kienu kkurati fil-passat bi prodotti ta' fattur VIII (inqas minn 1 minn kull 100 pazjent)
English: Peel back the lid from the clear plastic vial adapter package.
Maltese: Neħħi l-għatu mill-pakkett tal-plastik ċar tal-adapter tal-kunjett.
English: After infusing ReFacto AF, remove the infusion set and discard.
Maltese: Wara l-infużjoni ta' ReFacto AF, neħħi s-sett tal-infużjoni u armi.
English: Powder and solvent for solution for injection in pre-filled syringe FuseNGo
Maltese: Trab u solvent għal soluzzjoni għall-injezzjoni
English: ReFacto AF 1000 IU powder and solvent for solution for injection Each vial contains nominally 1000 IU* moroctocog alfa**.
Maltese: ReFacto AF 1000 IU trab u solvent għal soluzzjoni għall-injezzjoni Kull kunjett nominalment fih 1000
English: ReFacto AF 250 IU powder and solvent for solution for injection ReFacto AF 500 IU powder and solvent for solution for injection ReFacto AF 1000 IU powder and solvent for solution for injection ReFacto AF 2000 IU powder and solvent for solution for injection
Maltese: IU trab u solvent għal soluzzjoni għall-injezzjoni ReFacto AF 1000 IU trab u solvent għal soluzzjoni għall-injezzjoni ReFacto AF 2000
English: Whilst continuing to hold the ReFacto AF pre-filled syringe upright, remove the grey rubber tip cap and replace it with the protective blue vented cap.
Maltese: Reazzjoni allerġika magħrufa għall-proteini tal-ħamster.
English: Do not use ReFacto AF
Maltese: Tużax ReFacto AF
English: 1 pre filled syringe (250 IU powder in top chamber and 4 ml solvent in bottom chamber) 1 pre filled syringe (500 IU powder in top chamber and 4 ml solvent in bottom chamber) 1 pre filled syringe (1000 IU powder in top chamber and 4 ml solvent in bottom chamber) 1 pre filled syringe (2000 IU powder in top chamber and 4 ml solvent in bottom chamber) 1 pre filled syringe (3000 IU powder in top chamber and 4 ml solvent in bottom chamber)
Maltese: 1 siringa mimlija għal-lest (250 IU trab fil-kompartiment ta' fuq u 4 ml solvent fil-kompartiment ta' isfel)
English: Arthralgia
Maltese: Manifattur
English: Break off the tamper-resistant plastic tip cap from the solvent syringe by snapping the perforation of the cap.
Maltese: KONDIZZJONIJIET JEW RESTRIZZJONIJIET FIR-RIGWARD TAL-UŻU SIGUR U EFFIKAĊI TAL-PRODOTT MEDIĊINALI
English: • dizziness
Maltese: TAL-PRODOTT
English: Avoid touching the open end of the syringe or the protective blue vented cap.
Maltese: Evita li tmiss it-tarf miftuħ tas-siringa jew il-kappa mtaqqba lblu protettiva.
English: How to use ReFacto AF
Maltese: X'fih ReFacto AF
English: Repeat infusion every 8-24 hours until adequate wound healing, then therapy for at least another 7 days to maintain a factor VIII activity of 30% to 60% (IU/dl).
Maltese: Irrepeti, l-infużjoni kull 8-24 siegħa sakemm tfiq il-ġerħa, u agħti aktar terapija mill-anqas għall-7 ijiem oħra sabiex tinżamm l-attività tal-fattur VIII minn 30% sa 60% (IU/dl).
English: ATC code: C09C A04.
Maltese: Kodiċi ATC : C09C A04.
English: Aprovel contains lactose.
Maltese: Aprovel fih lactose.
English: F-75008 Paris - France
Maltese: F-75008 Paris - Franza
English: Date of first authorisation: 27 August 1997 Date of latest renewal: 27 August 2007
Maltese: Data tal-ewwel awtorizzazzjoni: 27 t'Awissu 1997 Data tal-aħħar tiġdid: 27 t'Awissu 2007
English: Ambarès & Lagrave F-33565 Carbon Blanc Cedex - France
Maltese: Ambarès & Lagrave F-33565 Carbon Blanc Cedex -Franza
English: The volume of distribution is 53-93 litres.
Maltese: Il-volum ta' distribuzzjoni huwa 53-93 litru.
English: 56 x 1 tablets:
Maltese: 56 x 1 pillola.
English: sanofi-aventis groupe 54, rue La Boétie F-75008 Paris - France
Maltese: sanofi-aventis groupe 54, rue La Boétie F-75008 Paris - Franza
English: 30 - 56 x 1 - 90 tablets:
Maltese: 30 - 56 x 1 - 90 pillola:
English: What Aprovel contains  The active substance is irbesartan.
Maltese: X'fih Aprovel - Is-sustanza attiva hi irbesartan.
English: The predefined blood pressure goal was ≤ 135/85 mmHg.
Maltese: L-għan predefinit kien għall-pressjoni ta' ≤ 135/85 mmHg.