FrancophonIA/ELRC3.0 huggingface dataset:
English: • The surgical checklist to be completed at the operating theatre immediately prior to the first incision confirming the right patient, the right product, the right side of the implantation, and the type of biological membrane and fibrin sealant to be used in the procedure.
Maltese: • Il-lista ta' kontroll kirurġika li timtela fis-sala tal-operazzjoni eżatt qabel l-ewwel inċiżjoni li tikkonferma l-pazjent korrett, il-prodott korrett, il-parti leminija tal-impjant, u t-tip ta' membrana bijoloġika u s-siġillanti li jridu jintużaw fil-proċedura abbażi tal-fibrina.
English: • The handling of ChondroCelect and its preparation for the implantation
Maltese: • Il-ġestjoni ta' ChondroCelect u l-preparazzjoni tiegħu għall-impjantazzjoni
English: • The need for screening of donors using patient questionnaire and laboratory tests for hepatitis C,
Maltese: • Il-ħtieġa għall-eżaminazzjoni tad-donaturi permezz ta' kwestjonarju lill-pazjenti u t-testijiet laboratorji għall-epatite Ċ, l-epatite B, l-HIV u s-sifilide
English: The Marketing Authorisation Holder (MAH) shall ensure that the medicinal product will be distributed only to Healthcare Establishments that meet criteria described in the Risk Management Plan.
Maltese: Id-Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq (Marketing Authorisation Holder (MAH)) għandu jassigura li l-prodott mediċinali jitqassam biss fi stabbilimenti tal-kura tas-saħħa li jilħqu lkriterji msemmija fil-Pjan ta' Ġestjoni tar-Riskji.
English: • Training material for other Healthcare Professionals • Informed consent for the patients to be signed prior to the treatment with ChondroCelect
Maltese: • Materjal għat-taħriġ ta' professjonisti oħra fil-kura tas-saħħa • Kunsens infurmat (tagħrif) għall-pazjenti li jridu jiġu ffirmati qabel il-kura b'ChondroCelect
English: • The handling of the biopsy harvest
Maltese: • Il-ġestjoni tal-proċedura ta' ġbir mill-bijopsija
English: Pneumococcal saccharide conjugated vaccine, adsorbed
Maltese: Vaċċin konjugat pneumococcal saccharide, assorbit
English: Prevenar contains the polysaccharides from different types of S. pneumoniae (serotypes 4, 6B, 9V, 14, 18C, 19F and 23F).
Maltese: Prevenar fih il-polisakkaridi minn tipi differenti ta' S. pneumoniae (serotipi 4, 6B, 9V, 14, 18C, 19F u 23F).
English: The full EPAR for Prevenar can be found on the Agency's website ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Maltese: L-EPAR sħiħ ta' Prevenar jinsab fuq is-sit elettroniku tal-Aġenzija ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: This summary was last updated in 01-2011.
Maltese: Dan is-sommarju ġie aġġornat l-aħħar f'01-2011.
English: This is a summary of the European public assessment report (EPAR) for Prevenar.
Maltese: Dan huwa sommarju tar-Rapport Pubbliku Ewropew ta' Valutazzjoni (EPAR) għal Prevenar.
English: In Europe, it is estimated that these are responsible for about 54% to 84% of invasive infections (infections that have spread into the body) in infants and children under the age of two years, and for about 62% to 83% of invasive infections in children aged between two and five
Maltese: Fl-Ewropa, hu stmat li dawn huma responsabbli għal bejn 54% sa 84% tal-infezzjonijiet invażivi (infezzjonijiet li jinxterdu mal-ġisem) fit-tfal żgħar u tfal ta' taħt l-età ta' sentejn, u għal bejn 62% sa 83% tal-infezzjonijiet invażivi fit-tfal li jkollhom bejn sentejn u ħames snin.
English: During the main study, 49 cases of infection due to the serotypes 4, 6B, 9V, 14, 18C, 19F and 23F of S. pneumoniae were seen among the infants who received the control vaccine, compared with three cases among the infants vaccinated with Prevenar.
Maltese: Matul l-istudju ewlieni, dehru 49 każ ta' infezzjoni mis-serotipi 4, 6B, 9V, 14, 18C, 19F u 23F ta' S. pneumoniae fost tfal żgħar li kienu qed jingħataw il-vaċċin tal-kontroll, imqabbla ma' tliet każijiet fost tfal żgħar imlaqqma bi Prevenar.
English: The most common side effects with Prevenar (seen in more than 1 patient in 10) are vomiting, diarrhoea, loss of appetite, reactions at the site of the injection (redness, hardening, swelling or pain), fever, irritability, drowsiness and restless sleep.
Maltese: L-effetti sekondarji l-aktar komuni ta' Prevenar (li dehru f'aktar minn pazjent wieħed minn kull għaxra) huma remettar, dijarrea, nuqqas ta' aptit, reazzjonijiet fil-post tal-injezzjoni (ħmura, ebusija, nefħa jew uġigħ), deni, irritabbiltà, sturdament u rqad mingħajr mistrieħ.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Prevenar to Wyeth Lederle Vaccines S.A. on 2 February 2001.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Prevenar lil Wyeth Lederle Vaccines S.A. fit-2 ta' Frar 2001.
English: Prevenar was effective in preventing S. pneumoniae invasive disease.
Maltese: Prevenar kien effikaċi fil-prevenzjoni tal-marda invażiva S. pneumoniae.
English: These include sepsis (blood infection), meningitis (infection of the membranes that surround the brain and spine), pneumonia (infection of the lungs), otitis media (infection of the middle ear) and bacteraemia (bacteria detected in the blood).
Maltese: Dawn jinkludu sepsi (infezzjoni fid-demm), meninġite (infezzjoni filmembrani li jdawru l-moħħ u s-sinsla tad-dahar), pulmonite (infezzjoni fil-pulmun), otite medja (infezzjoni fil-widna tan-nofs) u batterjemija (batterji li jinsabu fid-demm).
English: What is the risk associated with Prevenar?
Maltese: X'inhu r-riskju assoċjat ma' Prevenar?
English: Prevenar contains small amounts of polysaccharides (a type of sugar) extracted from the ‘capsule' that surrounds the S. pneumoniae bacterium.
Maltese: Prevenar fih ammonti żgħar ta' polisakkaridi (tip ta' zokkor) estratti mill-'kapsula' li ddawwar il-batterju S. pneumoniae.
English: The effectiveness of Prevenar in the prevention of S. pneumoniae invasive disease has been studied in almost 38,000 infants.
Maltese: L-effikaċja ta' Prevenar fil-prevenzjoni tal-marda invażiva S. pneumoniae ġiet studjata fi kważi 38,000 tifel u tifla żgħar.
English: Prevenar is a vaccine.
Maltese: Prevenar huwa vaċċin.
English: Prevenar was given at two, four, six and 12 to 15 months of age.
Maltese: Prevenar ingħata fl-etajiet ta' xahrejn, erba' xhur, sitt xhur u 12 sa 15-il xahar.
English: What benefit has Prevenar shown during the studies?
Maltese: X'benefiċċji wera Prevenar matul l-istudji?
English: However, the CHMP concluded that this is unlikely to lead to a difference in the rate of protection against infection with S. pneumoniae following a booster injection, when Prevenar is used as part of a routine immunisation programme in which most infants are vaccinated.
Maltese: Madankollu, is-CHMP ikkonkluda li aktarx mhux se jwassal għal differenza fir-rata ta' protezzjoni kontra infezzjoni bi S. pneumoniae wara injezzjoni buster, meta Prevenar jintuża bħala parti mill-programm ta' immunizzazzjoni ta' rutina fejn jitlaqqmu l-biċċa l-kbira tat-tfal żgħar.
English: The vaccine is also ‘adsorbed' (fixed) onto an aluminium compound to stimulate a better response.
Maltese: Il-vaċċin huwa wkoll 'assorbit' (jeħel) f'kompost tal-aluminju biex jistimula rispons aħjar.
English: It is a suspension for injection that contains parts of the bacterium Streptococcus pneumoniae (S. pneumoniae).
Maltese: Huwa sospensjoni għall-injezzjoni li fiha partijiet tal-batterju Streptococcus
English: Prevenar should not be used in children who may be hypersensitive (allergic) to the Streptococcus vaccine, to any of the other ingredients or to the diphtheria toxoid (a weakened toxin from the bacterium that causes diphtheria).
Maltese: Prevenar m'għandux jingħata lil tfal li jistgħu jkunu ipersensittivi (allerġiċi) għall-vaċċin Streptococcus, għal kwalunkwe sustanza oħra jew għat-tossojde difteriku (tossin dgħajjef mill-batterju li jikkawża ddifterite).
English: Additional studies looked at the effectiveness and safety of Prevenar in older infants and children, and at the development of antibodies in infants after the two-dose immunisation schedule followed by a
Maltese: Studji addizzjonali eżaminaw l-effikaċja u s-sigurtà ta' Prevenar fit-tfal mhux żgħar ħafna (older infants) u fit-tfal, u l-iżvilupp ta' antikorpi fit-tfal żgħar wara l-programm ta' immunizzazzjoni b'żewġ dożi
English: The immune system will then be able to produce antibodies more quickly when it is exposed to the bacterium again.
Maltese: L-istudji addizzjonali wrew li Prenavar kien sigur u effikaċi fit-tfal sal-età ta' ħames snin.
English: The vaccination schedule to be used depends on the age of the child and should be based on official
Maltese: It-tielet doża hi rakkomandata bejn l-età ta' sena u sentejn.
English: These polysaccharides have been purified, then ‘conjugated' (attached) to a carrier to help them be better recognised by the immune system.
Maltese: Dawn il-polisakkaridi jkunu ġew ippurifikati, imbagħad ‘konjugati' (imwaħħla) ma' sustanza li ġġorrhom biex ikunu jistgħu jintgħarfu aħjar mis-sistema immunitarja.
English: The CHMP decided that Prevenar's benefits are greater than its risks and recommended that Prevenar
Maltese: Għal-lista sħiħa ta' effetti sekondarji rrapportati bi Prevenar, ara l-Fuljett ta' Tagħrif.
English: Half of the infants received Prevenar, and the remainder received another vaccine that is not active against S. pneumoniae.
Maltese: Nofs it-tfal żgħar ingħataw Prevenar, u l-kumplament ingħataw vaċċin ieħor li mhuwiex attiv kontra S. pneumoniae.
English: It contains the active substance grapiprant.
Maltese: Fih is-sustanza attiva grapiprant.
English: Galliprant is a veterinary medicine.
Maltese: Galliprant huwa mediċina veterinarja.
English: This summary was last updated in November 2017.
Maltese: Dan is-sommarju ġie aġġornat l-aħħar f'Novembru 2017.
English: The full EPAR for Galliprant can be found on the Agency's website: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
Maltese: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
English: Galliprant contains grapiprant, a non-steroidal, non-cyclooxygenase inhibiting anti-inflammatory drug (NSAID), of the piprant class, that works in a different way from other NSAIDs, which block a range of cyclo-oxygenase enzymes.
Maltese: Galliprant għandu fih grapiprant, prodott antinfjammatorju inibittiv li huwa nonsterojdali u nonċiklossiġenażi (NSAID), tal-klassi tal-pipranti, li jaħdem b'mod differenti minn prodotti nonsterjodali antinflammatorji oħrajn, li jibblokkaw numru ta' enzimi ċiklossiġenażi.
English: This is a summary of the European public assessment report (EPAR) for Galliprant.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Galliprant.
English: In total, 51% of dogs (120 of 235) were treated successfully with Galliprant at 28 days after the start of the treatment.
Maltese: B'kollox, 51 % tal-klieb (120 minn 235) irċevew trattament b' Galliprant li ta riżultati pożittivi 28 jum wara l-bidu tat-trattament.
English: Why is Galliprant approved?
Maltese: Għal xiex ġiet approvat Galliprant?
English: This compared to 36% of dogs receiving a dummy treatment (82 of 231).
Maltese: Dan meta mqabbel ma' 36 % tal-klieb li ngħataw trattament finta (82 minn 231).
English: What are the risks associated with Galliprant?
Maltese: X'inhuma r-riskji assoċjati ma' Galliprant?
English: Grapiprant works by blocking a specific target receptor called EP4, through which natural substances called prostaglandins act to produce pain in osteoarthritis.
Maltese: Grapiprant jaħdem billi jimblokka r-riċettur fil-mira speċifiku EP4, li permezz tiegħu sustanzi naturali msejħin prostaglandini jaħdmu sabiex jikkawżaw l-uġigħ fl-osteoartrite.
English: For the full list of side effects and restrictions with Galliprant, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji u r-restrizzjonijiet b'Galliprant, ara l-fuljett ta' tagħrif.
English: Success was assessed by the dog owners and by veterinarians, using scoring systems for pain severity, pain interference and overall life quality.
Maltese: Il-livell ta' suċċess ġie vvalutat mis-sidien tal-klieb u mill-veterinarji bl-użu ta' sistemi ta' punteġġi għas-severità tal-uġigħ, l-interferenza tal-uġigħ u l-kwalità ġenerali tal-ħajja.
English: Other information about Galliprant?
Maltese: Informazzjoni oħra dwar Galliprant
English: The Agency's Committee for Medicinal Products for Veterinary Use (CVMP) concluded that Galliprant's benefits are greater than its risks and recommended that it be approved for use in the EU.
Maltese: Il-Kumitat għall-Prodotti Mediċinali għall-Użu Veterinarju (CVMP) tal-Aġenzija kkonkluda li l-benefiċċji ta' Galliprant huma akbar mir-riskji tiegħu u rrakkomanda li jkun approvat għall-użu fl-UE.
English: Two field studies were conducted involving dogs mostly with mild to moderate osteoarthritis confirmed by radiography in at least one limb joint.
Maltese: Jekk il-prodott jinbela' minn tifel jew tifla, jista' jkun li jiġu nnutati sinjali gastrointestinali mhux severi u riversibbli u nawżja.
English: Half-life (t1/2) (hours)
Maltese: Half-life (t1/2)
English: Osmolality: 272 mOsmol/kg.
Maltese: pH: 6.4. Osmolalità: 272 mOsmol/kg.
English: The procedures included 9 orthopaedic, 1 gastrointestinal, and 3 surgeries in the oral cavity.
Maltese: 9 kirurġiji ortopediċi, 1 gastrointestinali, u 3 kirurġiji fil-kavità orali.
English: Do not use Refixia:
Maltese: Tużax Refixia:
English: Polysorbate 80
Maltese: Polysorbate 80 Mannitol
English: Estimated mean factor IX trough levels IU/ml (95% CI)
Maltese: Stima tal-medja tal-livelli minimi ta' fattur IX IU/ml (95% CI)
English: Novo Nordisk A/S Brennum Park 25K DK-3400 Hillerød Denmark
Maltese: Novo Nordisk A/S Brennum Park 25K DK-3400
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 il-klassifikazzjoni tas-sistemi u tal-organi MedDRA (SOC, system organ classification u Preferred Term Level).
English: PK Parameter 0-6 years N=12
Maltese: Parametru PK 0-6 snin N=12
English: 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: <1/10); mhux komuni (≥1/1,000 sa <1/100); rari (≥1/10,000 sa <1/1,000); rari ħafna (<1/10,000),
English: A total of 69 (98.6%) of the 70 bleeding episodes were treated with one injection.
Maltese: Total ta' 69 (98.6%) mis70 episodju ta' fsada ġew ikkurati b'injezzjoni waħda.
English: The specific activity of Refixia is approximately 152 IU/mg protein.
Maltese: L-attività speċifika ta' Refixia hija madwar 152 IU/mg ta' proteina.
English: Table 3 Frequency of adverse reactions in clinical trials System Organ Class
Maltese: Tabella 3 Frekwenza tar-reazzjonijiet avversi fil-provi kliniċi Klassi tas-sistemi u tal-organi Reazzjoni avversa
English: Overdoses up to 169 IU/kg have been reported in clinical trials.
Maltese: Dożi eċċessivi sa 169 IU/kg ġew irrappurtati fi provi kliniċi.
English: The median (IQR) overall annual bleeding rate (ABR) in patients (13-65 years) treated with a prophylactic dose of 40 IU/kg once weekly was 1.04 (0.00; 4.01) whereas the traumatic ABR was 0.00 (0.00; 2.05), joint ABR was 0.97 (0.00; 2.07) and spontaneous ABR was 0.00 (0.00; 0.99).
Maltese: Il-medjan (IQR) tar-rata globali annwali ta' fsada (ABR, annual bleeding rate) f'pazjenti (13-65 sena) ikkurati b'doża profilattika ta' 40 IU/kg darba fil-ġimgħa kien ta' 1.04 (0.00; 4.01), filwaqt li l-ABR trawmatika kienet ta' 0.00 (0.00; 2.05), l-ABR tal-ġogi kienet ta' 0.97 (0.00; 2.07) u l-ABR spontanja kienet ta' 0.00 (0.00; 0.99).
English: Single-dose pharmacokinetic parameters of Refixia are listed by age in Table 5.
Maltese: Parametri farmakokinetiċi ta' doża waħda ta' Refixia huma elenkati skont l-età f'Tabella 5.
English: Submission of study results: Q2-2028
Maltese: Q2-2028
English: • The active substance is nonacog beta pegol (pegylated human coagulation factor IX (rDNA)).
Maltese: • Is-sustanza attiva hi nonacog beta pegol (fattur IX ta' koagulazzjoni tal-bniedem (rDNA) pegilat).
English: Powder: sodium chloride, histidine, sucrose, polysorbate 80, mannitol, sodium hydroxide, hydrochloric acid
Maltese: Trab: sodium chloride, histidine, sucrose, polysorbate 80, mannitol, sodium hydroxide, hydrochloric acid
English: Recommended dose IU/kg of Refixia
Maltese: Doża rakkomandata f'IU/kg ta' Refixia
English: Factor IX activity 168 h post dosing (IU/ml)
Maltese: Attività ta' Fattur IX 168 siegħa wara d dożaġġ (IU/ml)
English: CV = coefficient of variation.
Maltese: CV = koeffiċjent talvarjazzjoni.
English: ≥18 years N=6
Maltese: ≥18-il sena N=6
English: Additional doses of 40 IU/kg can be given.
Maltese: Jistgħu jingħataw dożi addizzjonali ta' 40 IU/kg.
English: INFORMATION IN BRAILLE Refixia 1000 IU
Maltese: INFORMAZZJONI BIL-BRAILLE Refixia 1000
English: Novo Nordisk A/S Novo Alle DK-2880 Bagsværd Denmark
Maltese: Novo Nordisk A/S Novo Alle DK-2880 Bagsværd Id-Danimarka
English: Of the 597 treated bleeds observed in 79 (75%) of the 105 patients, 521 (87%) of the bleeds were resolved with 1 injection and 60 (10%) of the bleeds were resolved with 2 injections of Refixia.
Maltese: Mill-597 episodju ta' fsada li ġew ikkurati li kienu osservati f'79 (75%) mill-105 pazjenti, 521 (87%) tal-episodji ta' fsada twaqqfu b'injezzjoni waħda u 60 (10%) tal-episodji ta' fsada twaqqfu b'2 injezzjonijiet ta' Refixia.
English: Mean residence time (MRT) (hours)
Maltese: residenza (MRT)
English: Pharmacokinetics were investigated in 16 adult and adolescent patients of which 6 were normal weight (BMI 18.5-24.9 kg/m2) and 10 were overweight (BMI 25-29.9 kg/m2).
Maltese: Il-farmakokinetika ġiet investigata f'16-il pazjent adult u adolexxenti, li minnhom 6 kellhom piż normali (BMI 18.5-24.9 kg/m2) u 10 kellhom piż żejjed (BMI 25-29.
English: In distribution and excretion studies in mice and rats, the 40 kDa polyethylene-glycol (PEG) moiety of Refixia was shown to be widely distributed to and eliminated from organs, and excreted via plasma in urine (44-56%) and faeces (28-50%).
Maltese: F'studji ta' distribuzzjoni u ta' tneħħija fil-ġrieden u fil-firien, intwera li l-parti 40 kDa polyethylene glycol (PEG) ta' Refixia hija distribwita u eliminata sew mill-organi , u mneħħija permezz tal-plażma fl-awrina (44-56%) u l-feċi (28-50%).
English: • Inject slowly over 1 to 3 minutes.
Maltese: • Injetta bil-mod fuq perjodu ta' 1 sa 3 minuti.
English: INFORMATION IN BRAILLE Refixia 2000 IU
Maltese: INFORMAZZJONI BIL-BRAILLE Refixia 2000
English: The primary amino acid sequence of the rFIX in Refixia is identical to the Ala148 allelic form of human plasma-derived factor IX.
Maltese: Is-sekwenza primarja ta' amino aċidi tal-rFIX f'Refixia hija identika għall-forma allelika Ala148 ta' fattur IX li ġej mill-plażma uman.
English: Volume of distribution (Vss) (ml/kg)
Maltese: Volum ta' distribuzzjoni (Vss) (ml/kg)
English: INFORMATION IN BRAILLE Refixia 500 IU
Maltese: INFORMAZZJONI BIL-BRAILLE Refixia 500
English: Area under the curve (AUC)0-168h (IU*hours/ml)
Maltese: Erja taħt il-kurva (AUC, Area under the curve)0-168h (IU*sigħat/ml)
English: Kidney disorder (nephrotic syndrome)
Maltese: Disturb fil-kliewi (sindrom nefrotiku)
English: • Keep this leaflet.
Maltese: • Iċċekkja d-data ta' skadenza.
English: Refixia is a purified recombinant human factor IX (rFIX) with a 40 kDa polyethylene-glycol (PEG) conjugated to the protein.
Maltese: Refixia hu fattur IX uman rikombinanti (rFIX) ippurifikat b'40 kDa polyethylene-glycol (PEG) ikkonjugat mal-proteina.
English: A double dose should be avoided.
Maltese: Doża doppja għandha tiġi evitata.
English: (2°C - 8°C) and 4 hours stored at room temperature (≤ 30°C).
Maltese: 8°C), u 4 sigħat meta nħażen f'temperatura tal-kamra (≤30°C).
English: For treatment of bleeds in paediatrics, the overall success rate (defined as excellent or good) was 93% (39 out of 42 bleeds), where 36 (86 %) of the bleeds were resolved with 1 injection, and 5 (12%) of the bleeds were resolved with 2 injections of Refixia.
Maltese: kienet ta' 93% (39 minn 42 fsada), fejn 36 (86%) tal-episodji ta' fsada twaqqfu b'injezzjoni waħda, u 5 (12%) mill-episodji ta' fsada twaqqfu b'2 injezzjonijiet ta' Refixia.
English: 7-12 years N=13
Maltese: 7-12-il sena N=13
English: The mean total consumption of Refixia during and after surgery was 241 IU/kg (range: 81-460 IU/kg).
Maltese: Il-medja tal-konsum totali ta' Refixia matul u wara l-kirurġija kienet ta' 241 IU/kg (medda: 81 - 460
English: 13-17 years N=3
Maltese: 13-17-il sena N=3
English: Sodium hydroxide (for pH adjustment) Hydrochloric acid (for pH adjustment)
Maltese: Sodium hydroxide (għal aġġustament tal-pH) Hydrochloric acid (għal aġġustament tal-pH)
English: Pharmacotherapeutic group: antihaemorrhagics, blood coagulation factor IX, ATC code: B02BD04.
Maltese: Kategorija farmakoterapewtika: antiemorraġiċi, fattur IX tal-koagulazzjoni tad-demm, Kodiċi ATC:
English: *recombinant human factor IX, produced in Chinese Hamster Ovary (CHO) cells by recombinant DNA technology, covalently conjugated to a 40 kDa polyethylene-glycol (PEG).
Maltese: *fattur IX uman rikombinanti, prodott fiċ-ċelluli tal-Ovarji tal-Ħamster Ċiniż (CHO) permezz ta' teknoloġija ta' DNA rikombinanti, ikkonjugat b'mod kovalenti ma' 40 kDa polyethylene-glycol (PEG).
English: Mean steady state factor IX trough levels above 15% were observed for all age groups, see section 5.2 for details.
Maltese: Ġew osservati livelli minimi medji ta' fattur IX fi stat fiss ogħla minn 15% għall-gruppi kollha ta' età, ara sezzjoni 5.2 għad-dettalji.
English: The pivotal trial included 74 adolescent (13-17 years) and adult (18-65 years) previously treated patients.
Maltese: Il-prova pivitali kienet tinkludi 74 pazjenti adolexxenti (minn 13 sa 17-il sena) u adulti (minn 18 sa 65 sena) li kienu kkurati qabel.
English: In the post-surgery period Day 1 to 6 and Day 7 to 13, the median number of additional 40 IU/kg doses administered was 2.0 and 1.5, respectively.
Maltese: Fil-perjodu ta' wara l-kirurġija, minn Jum 1 sa 6 u minn Jum 7 sa 13, il-medjan tan-numru ta' dożi addizzjonali ta' 40 IU/kg mogħtija kien ta' 2.0 u 1.5, rispettivament.
English: No difference in the safety profile of Refixia was observed between previously treated adolescent (12-18 years) and adult patients.
Maltese: Ma kienet osservata l-ebda differenza fil-profil ta' sigurtà ta' Refixia bejn pazjenti adolexxenti (12-18-il sena) u pazjenti adulti li kienu kkurati qabel.
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 rarely with recombinant factor IX products and may in some cases progress to severe anaphylaxis (including shock).
Maltese: Reazzjonijiet ta' sensittività eċċessiva jew allerġiċi (li jistgħu jinkludu anġjoedima, ħruq u tingiż fis-sit tal-infużjoni, tkexkix ta' bard, fwawar, urtikarja mifruxa, uġigħ ta' ras, ħorriqija, pressjoni baxxa, letarġija, nawsja, nuqqas ta' kwiet, takikardija, tagħfis fis-sider, tingiż, rimettar, tħarħir) ġew osservati b'mod rari bi prodotti tal-fattur IX rikombinanti u jistgħu f'xi każijiet jiżviluppaw f'anafilassi qawwija
English: Sodium chloride
Maltese: Sodium chloride Histidine Sucrose
English: Incremental Recovery (IR) (IU/ml per IU/kg)
Maltese: Inkrementali (IR) (IU/ml kull IU/kg)
English: Pruritus*
Maltese: Ħakk*
English: A total of 115 previously treated male patients with moderate or severe haemophilia B have been exposed to Refixia for a total of 170 patient years in the completed clinical trials.
Maltese: Total ta' 115-il pazjent raġel li kienu kkurati qabel, b'emofilja B moderata jew severa, ġew esposti għal Refixia għal total ta' 170 sena ta' pazjent fil-provi kliniċi li tlestew.