FrancophonIA/ELRC3.0 huggingface dataset:
English: Allergic type hypersensitivity reactions are possible with AFSTYLA.
Maltese: Huma possibbli reazzjonijiet ta' sensittività eċċessiva tat-tip allerġiku b'AFSTYLA.
English: België/Belgique/Belgien CSL Behring NV
Maltese: België/Belgique/Belgien
English: Lonoctocog alfa 1500 IU
Maltese: Lonoctocog alfa 1500
English: 1 disposable 5 ml syringe
Maltese: Stikka 1 mhux sterili
English: 1 disposable 5 ml syringe 1 venipuncture set
Maltese: 2 imselħiet bl-alkoħol stikka 1 mhux sterili
English: How to store AFSTYLA
Maltese: Tużax AFSTYLA
English: • Before the AFSTYLA powder is reconstituted it may be kept at room temperature (below
Maltese: • Qabel it-trab ta' AFSTYLA jiġi rrikostitwit huwa jista' jinżamm f'temperatura ambjentali (taħt
English: No age-specific differences in adverse reactions were observed between paediatric and adult subjects.
Maltese: Ma kienu osservati l-ebda differenzi speċifiċi għall-età fir-reazzjonijiet avversi bejn individwi pedjatriċi u adulti.
English: CSL Behring GmbH Emil-von-Behring Strasse 76 35041 Marburg GERMANY
Maltese: CSL Behring GmbH Emil-von-Behring Strasse 76 35041 Marburg IL-ĠERMANJA
English: 12 to <18 years (N=10) Mean (CV%) Median (Min,Max)
Maltese: minn 12 sa <18-il sena (N=10) Medja (CV%) Medjan (Min,Massimu)
English: Reporting suspected adverse reactions after authorization of the medicinal product is important.
Maltese: Huwa importanti li jiġu rrappurtati reazzjonijiet avversi suspettati wara l-awtorizzazzjoni talprodott mediċinali.
English: In patients with existing cardiovascular risk factors, substitution therapy with factor VIII may increase the cardiovascular risk.
Maltese: F'pazjenti b'fatturi kardjovaskulari ta' riskju diġà eżistenti, is-sostituzzjoni ta' terapija bil-fattur VIII tista' żżid ir-riskju kardjovaskulari.
English: Lonoctocog alfa 2500 IU
Maltese: Lonoctocog alfa 2500
English: Lonoctocog alfa 1000 IU
Maltese: Lonoctocog alfa 1000
English: • dizziness
Maltese: Preżentazzjonijiet
English: PK Parameters rVIII-SingleChain 50 IU/kg (N=81) Mean (CV%) Median (Min,Max)
Maltese: UI/kg (N=81) Medja (CV%) Medjan (Min,Massimu)
English: As the furin cleavage site present in wild type factor VIII between the Bdomain and the a3 domain was removed, AFSTYLA is expressed as a single-chain factor VIII molecule.
Maltese: Minħabba li s-sit tal-qasma furin preżenti fil-fattur VIII naturali bejn id-dominju B u d-dominju a3 tneħħa, AFSTYLA hija espressa bħala molekula tal-fattur VIII b'katina waħda.
English: All patients had been diagnosed with severe haemophilia A with <1% factor VIII.
Maltese: Il-pazjenti kollha kellhom dijanjosi ta' emofilja A severa b'<1% ta' fattur VIII.
English: Inhibitors
Maltese: Injezzjoni
English: The European Medicines Agency has deferred the obligation to submit the results of studies with AFSTYLA in the treatment of hereditary factor VIII deficiency in previously untreated paediatric patients (PUPs) (see section 4.2 for information on paediatric use).
Maltese: L-Aġenzija Ewropea għall-Mediċini ddiferiet l-obbligu li jiġu ppreżentati riżultati tal-istudji b'AFSTYLA fit-trattament ta' defiċjenza ereditarja tal-fattur VIII f'pazjenti pedjatriċi li qatt ma kienu ġew ittrattati qabel (PUPs previously untreated patients) (ara sezzjoni 4.2 għal informazzjoni dwar l-użu pedjatriku).
English: This medicine contains up to 7 mg (0.3 mmol) sodium per ml after reconstitution.
Maltese: Dan il-prodott mediċinali fih sa 7 mg (0.3 mmol) sodium f'kull ml wara r-rikostituzzjoni.
English: Lonoctocog alfa 500 IU
Maltese: Lonoctocog alfa 500
English: AFSTYLA 250 IU powder and solvent for solution for injection Powder (250 IU) in a 6 ml vial (type I glass) with a stopper (rubber), an orange disc (plastic), and a green striped cap (aluminium).
Maltese: IU trab u solvent għal soluzzjoni għall-injezzjoni Trab (250 IU) f'kunjett ta' 6 ml (ħġieġ tat-tip I) b'tapp (tal-lastku), diska oranġjo (tal-plastik) u għatu bl-istrixxi ħodor (tal-aluminju).
English: Common side effects (may affect up to 1 in 10 users)
Maltese: Effetti sekondarji komuni (jistgħu jaffettwaw sa utent 1 minn kull 10)
English: Study 3002 enrolled a total of 84 previously treated patients <12 years of age (35 <6 years of age and 49 6 to <12 years of age).
Maltese: (35 ta' <6 snin u 49 kellhom minn 6 snin sa <12-il sena).
English: 6 to <12 years (N=19) Mean (CV%) Median (Min,Max)
Maltese: minn 6 snin sa <12-il sena (N=19) Medja (CV%) Medjan (Min, Massimu)
English: AFSTYLA 2000 IU powder and solvent for solution for injection Lonoctocog alfa (recombinant coagulation factor VIII)
Maltese: IU trab u solvent għal soluzzjoni għall-injezzjoni Lonoctocog alfa (fattur VIII ta' koagulazzjoni rikombinat)
English: 250 IU Glass vial with a rubber stopper, an orange plastic disc, and a green striped aluminium cap 500 IU Glass vial with a rubber stopper, a blue plastic disc, and a green striped aluminium cap 1000 IU Glass vial with a rubber stopper, a green plastic disc, and a green striped aluminium cap 1500 IU Glass vial with a rubber stopper, a turquoise plastic disc, and a green striped aluminium cap 2000 IU Glass vial with a rubber stopper, a purple plastic disc, and a green striped aluminium cap 2500 IU Glass vial with a rubber stopper, a light grey plastic disc, and a green striped aluminium cap 3000 IU Glass vial with a rubber stopper, a yellow plastic disc, and a green striped aluminium cap
Maltese: Pakkett wieħed b'1500, 2000, 2500 jew 3000 UI li fih: kunjett 1 li fih it-trab kunjett 1 b'5 ml ilma għall-injezzjonijiet apparat wieħed 20/20 biex tiffiltra u tittrasferixxi Kaxxa waħda ta' ġewwa li fiha: siringa ta' 10 ml li tintrema wara li tintuża sett wieħed għat-titqib tal-vina 2 imselħiet bl-alkoħol stikka 1 mhux sterili
English: 0 to <6 years (N=20) Mean (CV%) Median (Min,Max)
Maltese: minn 0 sa <6 snin (N=20) Medja (CV%) Medjan (Min, Massimu)
English: AFSTYLA contains up to 7 mg (0.3 mmol) sodium per ml after reconstitution.
Maltese: AFSTYLA fih sa 7 mg (0.3 mmol) ta' sodium f'kull ml wara r-rikostituzzjoni.
English: AFSTYLA 1500 IU powder and solvent for solution for injection Powder (1500 IU) in a 10 ml vial (type I glass) with a stopper (rubber), a turquoise disc (plastic), and a green striped cap (aluminium).
Maltese: IU trab u solvent għal soluzzjoni għall-injezzjoni Trab (1500 IU) f'kunjett ta' 10 ml (ħġieġ tat-tip I) b'tapp (tal-lastku), diska turkważ (tal-plastik), għatu bl-istrixxi ħodor (tal-aluminju).
English: 2.5 ml of solvent in a vial (type I glass) with a stopper (rubber), a disc (plastic), and a cap (aluminium).
Maltese: 2.5 ml ta' solvent f'kunjett (ħġieġ tat-tip I), b'tapp (tal-lastku), diska (tal-plastik) u għatu (talaluminju).
English: Minor surgery including tooth extraction
Maltese: Jekk tinsa tuża AFSTYLA
English: Patients on prophylaxis 2- and 3-times per week were assigned median doses of 35 and 32 IU/kg per injection respectively with a median annual consumption across all prophylaxis regimens of 4,109 IU/kg year.
Maltese: Pazjenti fuq profilassi darbtejn jew 3 darbiet fil-ġimgħa kienu assenjati dożi medjani ta' 35 u 32 IU/kg għal kull injezzjoni rispettivament b'konsum annwali medjan tul l-iskeda ta' profilassi kollha ta' 4,109 IU/kg sena.
English: Treatment and prophylaxis of bleeding in patients with haemophilia A (congenital factor VIII deficiency).
Maltese: Trattament u profilassi għall-ħruġ ta' demm f'pazjenti b'emofilja A (defiċjenza konġenitali tal-fattur VIII).
English: Pyrexia common
Maltese: Sturdament komuni
English: AFSTYLA 1000 IU powder and solvent for solution for injection Powder (1000 IU) in a 6 ml vial (type I glass) with a stopper (rubber), a green disc (plastic), and a green striped cap (aluminium).
Maltese: IU trab u solvent għal soluzzjoni għall-injezzjoni Trab (1000 IU) f'kunjett ta' 6 ml (ħġieġ tat-tip I) b'tapp (tal-lastku), diska ħadra (tal-plastik), għatu bl-istrixxi ħodor (tal-aluminju).
English: 5 ml of solvent in a vial (type I glass) with a stopper (rubber), a disc (plastic), and a cap (aluminium).
Maltese: 5 ml ta' solvent f'kunjett (ħġieġ tat-tip I), b'tapp (tal-lastku), diska (tal-plastik) u għatu (talaluminju).
English: Individual patients may vary in their responses to factor VIII, demonstrating different half-lives and recoveries.
Maltese: Pazjenti individwali jista' jkollhom risponsi differenti għall-fattur VIII u juru half-lives u rkupru differenti.
English: One pack with 250, 500 or 1000 IU containing: 1 vial with powder
Maltese: Pakkett wieħed ta' 250, 500 jew 1000UI li fih: Kunjett wieħed tat-trab
English: One pack with 1500, 2000, 2500 or 3000 IU containing: 1 vial with powder
Maltese: Pakkett wieħed ta' 1500, 2000, 2500 jew 3000
English: AFSTYLA 500 IU powder and solvent for solution for injection AFSTYLA 1000 IU powder and solvent for solution for injection AFSTYLA 1500 IU powder and solvent for solution for injection AFSTYLA 2000 IU powder and solvent for solution for injection AFSTYLA 2500 IU powder and solvent for solution for injection AFSTYLA 3000 IU powder and solvent for solution for injection Lonoctocog alfa (recombinant, single-chain coagulation factor VIII)
Maltese: trab u solvent għal soluzzjoni għall-injezzjoni kunjett wieħed li fih it-trab 3000 IU lonoctocog alfa (600 UI/ml wara r-rikostituzzjoni) kunjett wieħed b'5 ml ilma għall-injezzjonijiet apparat wieħed 20/20 biex tiffiltra u tittrasferixxi Kaxxa waħda ta' ġewwa li fiha: siringa ta' 10 ml li tintrema wara li tintuża sett wieħed għat-titqib tal-vina
English: AFSTYLA can be used for all age groups.
Maltese: AFSTYLA jista' jintuża għall-gruppi ta' etajiet kollha.
English: AFSTYLA 2000 IU powder for solution for injection Lonoctocog alfa
Maltese: IU trab għal soluzzjoni għall-injezzjoni Lonoctocog alfa
English: Monitoring laboratory tests
Maltese: DATA TA' REVIŻJONI TAT-TEST
English: Skin and subcutaneous tissue disorders
Maltese: • uġigħ fil-post tal-injezzjoni
English: Treatment of bleeding: Of the 347 bleeding events observed during Study 3002, 95.7%were controlled with 2 or fewer injections.
Maltese: Mit-347 avveniment ta' ħruġ ta' demm osservati matul l-Istudju 3002, 95.7% kienu kkontrollati b'2 injezzjonijiet jew anqas.
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 infurmati bl-ewwel sinjali ta' reazzjonijiet ta' sensittività eċċessiva inkluż ħorriqija, urtikarja mifruxa, tagħfis fis-sider, tħarħir, pressjoni baxxa, u anafilassi.
English: The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the marketing authorisation and any agreed subsequent updates of the RMP.
Maltese: L-MAH għandu jwettaq l-attivitajiet u l-interventi meħtieġa ta' farmakoviġilanza dettaljati fir-RMP maqbul ippreżentat fil-Modulu 1.8.2 tal-Awtorizzazzjoni għat-Tqegħid fis-Suq u kwalunkwe aġġornament sussegwenti maqbul tar-RMP.
English: Uncommon side effects (may affect up to 1 in 100 users)
Maltese: Effetti sekondarji mhux komuni (jistgħu jaffettwaw sa utent 1 minn kull 100)
English: AFSTYLA 3000 IU powder and solvent for solution for injection Each vial contains nominally 3000 IU recombinant, single-chain coagulation factor VIII (rVIIISingleChain, INN = lonoctocog alfa).
Maltese: UI trab u solvent għal soluzzjoni għall-injezzjoni B'mod nominali kull kunjett fih 3000 UI ta' fattur VIII tal-koagulazzjoni tal-bniedem b'katina waħda rikombinat (rVIII b'Katina Waħda, INN = lonoctocog alfa).
English: AFSTYLA is a single polypeptide chain with a truncated B-domain that allows for a covalent bridge to link the factor VIII heavy and light chains.
Maltese: AFSTYLA huwa katina waħda ta' polypeptide b'dominju B mqassar li jippermetti li pont kovalenti jgħaqqad katini tqal u ħfief tal-fattur VIII.
English: The product contains traces of hamster proteins.
Maltese: UI/mg proteina.
English: The median dose to treat a bleeding episode was 34.7 IU/kg.
Maltese: Il-medjan tad-doża biex titratta episodju ta' ħruġ ta' demm kien ta' 34.7 UI/kg.
English: powder and solvent for solution for injection 1 vial with powder: 250 IU lonoctocog alfa (100 IU/ml after reconstitution) 1 vial with 2.5 ml water for injections 1 filter transfer device 20/20
Maltese: IU lonoctocog alfa (100 UI/ml wara r-rikostituzzjoni) kunjett wieħed b'2.5 ml ilma għall-injezzjonijiet apparat wieħed 20/20 biex tiffiltra u tittrasferixxi Kaxxa waħda ta' ġewwa li fiha: siringa ta' 5 ml li tintrema wara li tintuża sett wieħed għat-titqib tal-vina
English: 250 IU per vial; after reconstitution with 2.5 ml of water for injections the solution contains 100 IU/ml of lonoctocog alfa.
Maltese: UI f'kull kunjett; wara r-rikostituzzjoni b'2.5 ml ta' ilma għall-injezzjonijiet is-soluzzjoni jkun fiha 100 UI/ml ta' lonoctocog alfa.
English: No age-specific differences in adverse reactions were observed between children, adolescents and adult subjects.
Maltese: Ma kienu osservati l-ebda differenzi speċifiċi għall-età fir-reazzjonijiet avversi bejn individwi tfal adolexxenti u adulti.
English: 1 non- sterile plaster
Maltese: Ilma għall-injezzjonijiet
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: B'mod partikolari fil-każ ta' interventi kirurġiċi kbar, il-monitoraġġ preċiż tat terapija ta' sostituzzjoni permezz ta' analiżi ta' koagulazzjoni (attività tal-fattur VIII fil-plażma) huwaindispensabbli.
English: While the product vial is upright, connect the syringe to the Mix2Vial's Luer Lock fitting by screwing clockwise.
Maltese: Kun ċert li tiġbed 'il barra l-pakkett biss u mhux is-sett Mix2Vial ukoll.
English: 500 IU per vial; after reconstitution with 2.5 ml of water for injections the solution contains 200 IU/ml of lonoctocog alfa.
Maltese: UI f'kull kunjett; wara r-rikostituzzjoni b'2.5 ml ta' ilma għall-injezzjonijiet is-soluzzjoni jkun fiha 200 UI/ml ta' lonoctocog alfa.
English: Powder (2500 IU) in a 10 ml vial (type I glass) with a stopper (rubber), a light grey disc (plastic), and a green striped cap (aluminium).
Maltese: IU) f'kunjett ta' 10 ml (ħġieġ tat-tip I) b'tapp (tal-lastku), diska griża ċara (tal-plastik), għatu bl-istrixxi ħodor (tal-aluminju).
English: Pharmacokinetic Parameters following a Single Injection of 50 IU/kg of AFSTYLAChromogenic Substrate Assay:
Maltese: UI/kg ta' AFSTYLA - Assaġġ b'Sustrat Kromoġeniku:
English: 2000 IU per vial; after reconstitution with 5 ml of water for injections the solution contains 400 IU/ml of lonoctocog alfa.
Maltese: UIf'kull kunjett; wara r-rikostituzzjoni b'5 ml ta' ilma għall-injezzjonijiet is-soluzzjoni jkun fiha 400 UI/ml ta' lonoctocog alfa.
English: No interactions of human coagulation factor VIII products with other medicinal products have been reported.
Maltese: Ma kienu rrappurtati l-ebda interazzjonijiet bejn prodotti ta' fattur VIII ta' koagulazzjoni fil-bniedem u prodotti mediċinali oħra.
English: The PK parameters were based on plasma factor VIII activity measured by the chromogenic substrate assay (for discrepancy in the factor VIII activity determined with one-stage clotting assay, please see Section 4.2).
Maltese: Il-parametri PK kienu bbażati fuq l-attività tal-fattur VIII fil-plażma mkejla permezz tal-assaġġ ta' sustrat kromoġeniku (għal diskrepanza fl-attività tal-fattur VIII stabbilita permezz ta' assaġġ ta' tagħqid tad-demm bi stadju wieħed, jekk jogħġbok ara Sezzjoni 4.2).
English: • feeling hot
Maltese: X'fih AFSTYLA
English: powder and solvent for solution for injection 1 vial with powder: 500 IU lonoctocog alfa (200 IU/ml after reconstitution) 1 vial with 2.5 ml water for injections 1 filter transfer device 20/20
Maltese: IU lonoctocog alfa (200 UI/ml wara r-rikostituzzjoni) kunjett wieħed b'2.5 ml ilma għall-injezzjonijiet apparat wieħed 20/20 biex tiffiltra u tittrasferixxi Kaxxa waħda ta' ġewwa li fiha: siringa ta' 5 ml li tintrema wara li tintuża sett wieħed għat-titqib tal-vina
English: Take the Mix2Vial together with the blister package and push the spike of the blue adapter end straight down through the solvent vial stopper.
Maltese: Ħu l-Mix2Vial bil-pakkett b'kollox u mbotta l-ponta tat-tarf tal-adapter il-blu dritt 'l isfel minn ġot-tapp tal-kunjett tas-solvent.
English: AFSTYLA 2000 IU powder and solvent for solution for injection Each vial contains nominally 2000 IU recombinant, single-chain coagulation factor VIII (rVIIISingleChain, INN = lonoctocog alfa).
Maltese: UI ta' fattur VIII tal-koagulazzjoni tal-bniedem b'katina waħda rikombinat (rVIII b'Katina Waħda, INN = lonoctocog alfa).
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 VIII attivat jiffunzjona bħala kofattur għall-fattur IX attivat, li jaċċellera l-bidla tal-fattur X f'fattur X attivat.
English: The following table can be used to guide dosing in bleeding episodes and surgery:
Maltese: Immaniġġjar qabel u wara operazzjoni (profilassi kirurġika):
English: AFSTYLA 2500 IU powder for solution for injection Lonoctocog alfa
Maltese: UI trab u solvent għal soluzzjoni għall-injezzjoni AFSTYLA 2500
English: One International Unit (IU) of factor VIII activity is equivalent to that quantity of factor VIII in one ml of normal human plasma.
Maltese: Unità Internazzjonali (UI) waħda ta' attività tal-fattur VIII hija ekwivalenti għal dik il-kwantità ta' fattur VIII f'ml wieħed ta' plażma normali tal-bniedem.
English: Pruritus uncommon
Maltese: Reazzjoni avversa
English: The frequencies in the table below were observed in completed clinical studies in previously treated patients with severe haemophilia A.
Maltese: Il-frekwenzi fit-tabella taħt ġew osservati fi studji kliniċi li tlestew f'pazjenti li diġà kienu ġew ittrattati qabel li kellhom emofilja A severa.
English: Also there can be significant discrepancies between assay results obtained by aPTT-based one stage clotting assay and the chromogenic assay according to Ph. Eur.
Maltese: Dan huwa ta' importanza b'mod partikolari meta wieħed jibdel il-laboratorju u/jew ir-reaġenti użati fl-assaġġ.
English: Feeling hot uncommon *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: Vss (volume of distribution at steady state) = volum ta' distribuzzjoni fl-istat fiss aġġustat għall-piż tal-ġisem.
English: For adolescents of 12 years of age and above, the dose recommendations are the same as for adults.
Maltese: Għal adolexxenti ta' 12-il sena u aktar, id-doża rrakkomandata hija l-istess bħal dik tal-adulti.
English: Teva Pharma Belgium N.V./S.A
Maltese: Teva Pharma Belgium N.V./S.
English: United Kingdom Hikma Farmacêutica (Portugal), S.A.
Maltese: Hikma Farmacêutica (Portugal), S.A.
English: Latvia
Maltese: Letland
English: Ireland
Maltese: Ierland
English: Italy
Maltese: Italië
English: Iceland
Maltese: IJsland
English: Greece
Maltese: Griekenland
English: Metilprednisolon Teva Methylprednisolone 40mg/Ml
Maltese: Metilprednisolon Teva Metilpredniżolon 40 mg/Ml
English: Metilprednizolon Teva Methylprednisolone 40mg/Ml
Maltese: Metilprednizolon Teva Metilpredniżolon 40 mg/Ml
English: Metylprednizolón Hikma Methylprednisolone 53mg Vial
Maltese: Metylprednizolón Hikma Metilpredniżolon 53 mg Kunjett
English: Methylprednisolone Sodium Succinate 53.03mg/Ml
Maltese: Suċċinat tas-Sodju ta' Metilpredniżolon 53.03 mg/Ml
English: Pfizer, Spol.
Maltese: Ir-Repubblika Ċeka Pfizer, Spol.
English: Methylprednisolone Sodium Succinate 53.2mg/Ml
Maltese: Suċċinat tas-Sodju ta' Metilpredniżolon 53.2 mg/Ml
English: Methylprednisolone Hemisuccinate 50.7mg Vial
Maltese: Emisuċċinat ta' Metilpredniżolon 50.7 mg Kunjett
English: Solution For Injection Intramuscular Use | Intravenous Use
Maltese: Lista ta' prodotti mediċinali awtorizzati fuq livell nazzjonali
English: Methylprednisolone 40mg Tablet
Maltese: Metilpredniżolon 40 mg Pillola
English: Methylprednisolone 120mg Bottle
Maltese: Metilpredniżolon 120 mg Flixkun
English: The full EPAR for Pravafenix can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Maltese: L-EPAR sħiħ għal Pravafenix jista' jiġi kkonsultat fis-sit elettroniku tal-Aġenzija: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: Fenofibrate is a ‘PPAR agonist'.
Maltese: Fenofibrate huwa ‘agonista tal-PPAR'.
English: It is available as green and olive capsules containing 40 mg pravastatin and 160 mg fenofibrate.
Maltese: Huwa disponibbli bħala kapsuli ħodor u kulur iż-żebbuġa li fihom 40 mg pravastatin u 160 mg fenofibrate.
English: This is a summary of the European public assessment report (EPAR) for Pravafenix.
Maltese: Dan huwa sommarju tar-Rapport Pubbliku Ewropew ta' Valutazzjoni (EPAR) għal Pravafenix.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Pravafenix to Laboratoires SMB s.a. on 14 April 2011.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Pravafenix lil Laboratoires SMB s.a. fi 14 April 2011.
English: It activates a type of receptor called the ‘peroxisome proliferator-activated receptor alpha', which is involved in breaking down fat from the diet, especially triglycerides.
Maltese: Jattiva tip ta' riċettur imsejjaħ il-‘peroxisome proliferator-activated receptor alpha', li huwa involut fit-tkissir tax-xaħam mid-dieta, b'mod speċjali ttrigliċeridi.
English: The most common side effects with Pravafenix (seen in between 1 and 10 patients in 100) are abdominal distension (bloating), abdominal pain (stomach ache), constipation, diarrhoea, dry mouth, dyspepsia (heartburn), eructation (belching), flatulence (gas), nausea (feeling sick), abdominal discomfort, vomiting and raised blood levels of liver enzymes.
Maltese: L-effetti sekondarji l-aktar komuni bi Pravafenix (li dehru f'bejn pazjent 1 u 10 minn kull 100) huma distensjoni addominali (nefħa), uġigħ addominali (uġigħ fl-istonku), stitikezza, dijarrea, ħalq xott, dispepsja (ħruq ta' stonku), tifwiq, gass, nawżja (dardir), skumdità addominali, remettar u livelli taddemm tal-enzimi tal-fwied għoljin.
English: Pravastatin belongs to the group called ‘statins'.
Maltese: Pravastatin jappartjeni għall-grupp imsejjaħ ‘statins'.
English: Non-HDL-cholesterol levels were reduced on average by around 14% in patients taking Pravafenix compared with 6% in patients taking pravastatin alone.
Maltese: Il-livelli tal-kolesterol non-HDL tnaqqsu bħala medja b'madwar 14% f'pazjenti li kienu qegħdin jieħdu Pravafenix meta mqabbel ma' 6% f'pazjenti li kienu qegħdin jieħdu pravastatin waħdu.
English: Other information about Pravafenix
Maltese: Informazzjoni oħra dwar Pravafenix
English: It reduces total blood cholesterol by blocking the action of HMG-CoA reductase, an enzyme in the liver involved in the production of cholesterol.
Maltese: Inaqqas il-kolesterol totali fid-demm billi jimblokka l-azzjoni ta' HMG-CoA reductase, enzim fil-fwied involut fil-produzzjoni tal-kolesterol.
English: This summary was last updated in 02-2011.
Maltese: Is-sommarju ġie aġġornat l-aħħar f'02-2011.
English: Why has Pravafenix been approved?
Maltese: Għaliex ġie approvat Pravafenix?
English: In the main study Pravafenix was shown to be more effective than pravastatin alone in reducing nonHDL-cholesterol levels.
Maltese: Fl-istudju prinċipali, Pravafenix intwera li kien aktar effettiv minn pravastatin waħdu fit-tnaqqis tallivelli tal-kolesterol non-HDL.