FrancophonIA/ELRC3.0 huggingface dataset:
English: These may be signs of a rare severe sudden allergic reaction to Kovaltry.
Maltese: Dawn jistgħu jkunu sinjali ta' reazzjoni allerġika rari u severa li sseħħ għal għarrieda għal Kovaltry.
English: INFORMATION IN BRAILLE Kovaltry 1000
Maltese: INFORMAZZJONI BIL-BRAILLE Kovaltry 1000
English: Two multi-centre, open-label, cross-over, uncontrolled, randomised studies in previously treated adults/adolescents with severe haemophilia A (< 1%) and one multi-centre, open-label, uncontrolled study in previously treated children < 12 years with severe haemophilia A were conducted.
Maltese: Żewġ studji multiċentriċi, open-label, cross-over, mhux ikkontrollati, li fihom il-parteċipanti ntgħażlu b'mod każwali, li saru f'adulti/adolexxenti emofilja A severa (< 1%) li ġew ikkurati fil-passat qabel, u studju wieħed multiċentriku, open-label, mhux ikkontrollat, li twettaq fi tfal li ġew ikkurati fil-passat, li kellhom < 12-il sena, b'emofilja A severa.
English: The FVIII:C of Kovaltry can be measured in plasma with a one-stage coagulation assay as well as with a chromogenic assay using the routine methods of the laboratory.
Maltese: L-FVIII:C ta' Kovaltry jista' jitkejjel fil-plażma b'assaġġ tal-koagulazzjoni ta' stadju wieħed kif ukoll b'assaġġ kromoġeniku permezz tal-metodi ta' rutina tal-laboratorju.
English: Kovaltry contains sodium
Maltese: Kovaltry fih is-sodium
English: INFORMATION IN BRAILLE Kovaltry 3000
Maltese: INFORMAZZJONI BIL-BRAILLE Kovaltry 3000
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 and may in some cases progress to severe anaphylaxis (including shock).
Maltese: Sensittività eċċessiva jew reazzjonijiet allerġiċi (li jistgħu jinkludu anġjoedima, ħruq u tingiż fis-sit tal-infużjoni, tertir ta' bard, fwawar, urtikarja ġeneralizzata, uġigħ ta' ras, ħorriqija, pressjoni baxxa, letarġija, dardir, nuqqas ta' kwiet, takikardija, għafis tas-sider, tnemnim, rimettar, tħarħir) ġew osservati u f'xi każijiet jistgħu jiżviluppaw f'anafilassi severa (li tinkludi xokk).
English: How to store Kovaltry
Maltese: Trab ta' Kovaltry.
English: INFORMATION IN BRAILLE Kovaltry 500
Maltese: INFORMAZZJONI BIL-BRAILLE Kovaltry 500
English: For patients who have received previous treatment with factor VIII (more than 150 days of treatment) inhibitor antibodies (see section 2) may form uncommonly (less than 1 in 100 patients).
Maltese: Għal pazjenti li kienu kkurati qabel b'fattur VIII (aktar minn 150 jum ta' kura), antikorpi inibituri (ara sezzjoni 2) jistgħu jiffurmaw b'mod mhux komuni (inqas minn pazjent 1 minn kull 100).
English: Kovaltry does not contain von Willebrand factor.
Maltese: Kovaltry ma fihx il-fattur von Willebrand.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Kovaltry 1000 IU contains (1000 IU / 2.5 mL) = 400 IU octocog alfa per mL after reconstitution.
Maltese: IU fih (1000 IU / 2.5 mL) = 400 IU octocog alfa f'kull mL wara r-rikostituzzjoni.
English: In an international study involving 41 clinical laboratories, the performance of Kovaltry in FVIII:C assays was evaluated and compared to a marketed full length rFVIII product.
Maltese: Fi studju internazzjonali li kien jinvolvi 41 laboratorju kliniku, il-prestazzjoni ta' Kovaltry f'assaġġi FVIII:C ġiet evalwata u mqabbla ma' prodott rFVIII b'tul sħiħ li kien imqiegħed fis-suq.
English: • one pre-filled syringe with 2.5 mL (for 250 IU, 500 IU and 1000 IU) or 5 mL (for 2000 IU and
Maltese: IU fih (250 IU / 2.5 mL) = 100
English: Detailed information on this medicine is available on the website of the European Medicines Agency 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: Date of first authorisation: 18 February 2016
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 18 ta' Frar 2016
English: * Frequency is based on studies with all FVIII products which included patients with severe haemophilia A. PTPs = previously-treated patients, PUPs = previously-untreated patients ** includes injection site extravasation, hematoma, infusion site pain, pruritus, swelling *** rash, rash erythematous, rash pruritic
Maltese: PTPs = pazjenti kkurati qabel, PUPs = pazjenti li ma kinux ittrattati qabel ** jinkludi ħruġ ta' fluwidu mis-sit tal-injezzjoni, ematoma, uġigħ fis-sit tal-infużjoni, ħakk, nefħa *** raxx, raxx eritematuż, raxx pruritiku
English: Kovaltry 250 IU powder and solvent for solution for injection One mL Kovaltry 250 IU contains approximately 100 IU (250 IU / 2.5 mL) of recombinant human coagulation factor VIII (INN: octocog alfa) after reconstitution with water for injections.
Maltese: IU fih madwar 100 IU (250 IU / 2.5 mL) ta' fattur VIII tal-koagulazzjoni umana rikombinanti (INN: octocog alfa) wara r-rikostituzzjoni b'ilma għall-injezzjonijiet.
English: No interactions of human coagulation factor VIII (rDNA) products with other medicinal products have been reported.
Maltese: Ma ġew irrappurtati l-ebda interazzjonijiet ta' prodotti li fihom fattur VIII ta' koagulazzjoni umana (rDNA) ma' prodotti mediċinali oħrajn.
English: Kovaltry should be reconstituted and administered with the components (vial adapter, prefilled syringe, venipuncture set) provided with each package.
Maltese: Kovaltry għandu jiġi rikostitwit u mogħti permezz tal-komponenti (adapter tal-kunjett, siringa mimlija għal-lest, sett għattitqib tal-vina) ipprovduti ma' kull pakkett.
English: Kovaltry 250 IU powder and solvent for solution for injection Kovaltry 500 IU powder and solvent for solution for injection Kovaltry 1000 IU powder and solvent for solution for injection Kovaltry 2000 IU powder and solvent for solution for injection Kovaltry 3000 IU powder and solvent for solution for injection
Maltese: Kovaltry 3000 IU trab u solvent għal soluzzjoni għall-injezzjoni 1 mL ta' Kovaltry 3000 IU fih madwar 600
English: Kovaltry contains the active substance human recombinant coagulation factor VIII, also called octocog alfa.
Maltese: Kovaltry fih is-sustanza attiva fattur VIII tal-koagulazzjoni humana rikombinanti, imsejħa wkoll octagon alpha.
English: Kovaltry is available in pack sizes of: 1 single pack 1 multipack with 30 single packs Not all pack sizes may be marketed.
Maltese: Daqsijiet tal-Pakkett pakkett b'wieħed. pakkett multiplu bi 30 pakkett ta' wieħed.
English: Kovaltry can be used in children of all ages.
Maltese: Kovaltry jista' jintuża fi tfal ta' kull età.
English: Kovaltry is used to treat and prevent bleeding in adults, adolescents and children of all ages with haemophilia A (hereditary factor VIII deficiency).
Maltese: Kovaltry jintuża biex jittratta u jipprevjeni fsada f'adulti, adolexxenti u tfal ta' kull età li għandhom l-emofilja A (nuqqas ereditarju tal-fattur VIII).
English: A. LABELLING
Maltese: • indiġestjoni
English: NAME OF THE MEDICINAL PRODUCT Kovaltry 3000 IU powder and solvent for solution for injection recombinant human coagulation factor VIII (octocog alfa)
Maltese: Kovaltry 3000 IU trab u solvent għal soluzzjoni għall-injezzjoni fattur VIII rikombinanti uman tal-koagulazzjoni (octocog alfa)
English: No animal fertility studies have been conducted with Kovaltry and its effect on human fertility has not been established in controlled clinical trials.
Maltese: Ma twettqux studji dwar il-fertilità fl-annimali b'Kovaltry, u l-effett tiegħu fuq il-fertilità umana ma ġiex stabbilit fi provi kliniċi kkontrollati.
English: Repeated PK measurements after 6 to 12 months of prophylaxis treatment with Kovaltry did not indicate any relevant changes in PK characteristics after long-term treatment.
Maltese: Kejl ripetut tal-PK wara minn 6 sa 12-il xahar ta' kura ta' profilassi b'Kovaltry ma indika l-ebda tibdil rilevanti fil-karatteristiċi PK wara kura fit-tul.
English: * Based on population PK estimates **AUC calculated for a dose of 50 IU/kg
Maltese: * Ibbażat fuq estimi PK tal-popolazzjoni ** AUC ikkalkulata għal doża ta' 50
English: BW: Body weight *Success rate defined as % of bleeds treated successfully with ≤ 2 infusions
Maltese: BW: Piż tal-ġisem * Ir-rata ta' suċċess definit bħala % tal-ħruġ ta' demm ikkurat b'suċċess b'≤ 2 infużjonijiet
English: For instructions on reconstitution of the medicinal product before administration, see section 6.6 and the package leaflet.
Maltese: Għal istruzzjonijiet fuq ir-rikostituzzjoni tal-prodott mediċinali qabel jingħata, ara sezzjoni 6.6 u lfuljett ta' tagħrif.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 5 mL [for reconstitution of strengths 2000/3000 IU]
Maltese: INDIVIDWALI 5 mL [għar-rikostituzzjoni tal-qawwiet 2000/3000
English: APPROPRIATE
Maltese: Inibituri
English: Rarely, inhibitors may develop after the first 50 exposure days but continues throughout life although the risk is uncommon.
Maltese: Rarement, wieħed jista' jiżviluppa inibituri wara l-ewwel 50 ġurnata ta' esponiment iżda dan ikompli matul il-ħajja kollha għalkemm ir-riskju mhux komuni.
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: Il-monitoraġġ preċiż tat-terapija ta' sostituzzjoni permezz ta' analiżi tal-koagulazzjoni (l-attivà talfattur VIII fil-plażma) huwa indispensabbli, speċjalment fil-każ ta' interventi kirurġiċi maġġuri.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 2.5 mL [for reconstitution of strengths 250/500/1000 IU]
Maltese: IL-KONTENUT SKONT IL-PIŻ, IL-VOLUM, JEW PARTI INDIVIDWALI 2.5 mL [għar-rikostituzzjoni tal-qawwiet 250/500/1,000 IU]
English: Ensure that the full content of the vial is drawn into the syringe.
Maltese: Kun ċert li t-trab ikun inħall kompletament.
English: Kovaltry powder should only be reconstituted with the supplied solvent (2.5 mL or 5 mL water for injections) in the prefilled syringe and the vial adapter.
Maltese: għandu jiġi rrikostitwit biss bis-solvent ipprovdut (2,5 mL jew 5 mL ilma għallinjezzjonijiet) fis-siringa mimlija lesta u adapter tal-kunjett.
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 ikollu inqas riskju ta' rispons kliniku insuffiċjenti minn inibituri b'titru għoli.
English: The Pharmacokinetic (PK) profile of Kovaltry was evaluated in PTPs with severe haemophilia A following 50 IU/kg in 21 subjects ≥ 18 years, 5 subjects ≥ 12 years and < 18 years and 19 subjects < 12 years of age.
Maltese: IU/kg f'21 individwu li kellhom ≥ 18-il sena, 5 individwi li kellhom ≥ 12-il sena u < 18-il sena u 19-il individwi li kellhom < 12-il sena.
English: Kovaltry 250 IU powder and solvent for solution for injection Kovaltry 500 IU powder and solvent for solution for injection Kovaltry 1000 IU powder and solvent for solution for injection Kovaltry 2000 IU powder and solvent for solution for injection Kovaltry 3000 IU powder and solvent for solution for injection recombinant human coagulation factor VIII (octocog alfa)
Maltese: IU trab u solvent għal soluzzjoni għall-injezzjoni Kovaltry 3000 IU trab u solvent għal soluzzjoni għall-injezzjoni fattur VIII rikombinanti tal-koagulazzjoni umana (octocog alfa)
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1076/024 - 30 x (Kovaltry 3000 IU - solvent (5 mL); pre-filled syringe (5 mL)) 13.
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/15/1076/024 - 30 x (Kovaltry 3000 IU - solvent (5 mL); siringa mimlija għal-lest (5 mL)) 13.
English: Kovaltry is not likely to affect the fertility in male or female patients, as the active substance is naturally occurring in the body.
Maltese: Kovaltry mhux probabbli li jaffettwa l-fertilità f'pazjenti rġiel jew nisa, peress li s-sustanza attiva tinstab b'mod naturali fil-ġisem.
English: May be stored at temperatures up to 25 °C for up to 12 months within the expiry date indicated on the label.
Maltese: Jista' jinħażen f'temperaturi sa 25 °C għal sa 12-il xahar sad-data ta' skadenza indikata fuq it-tikketta.
English: Dysgeusia uncommon
Maltese: Solvent Ilma għall-injezzjonijiet
English: PHARMACEUTICAL FORM AND CONTENTS powder and solvent for solution for injection
Maltese: GĦAMLA FARMAĊEWTIKA U KONTENUT trab u solvent għal soluzzjoni għall-injezzjoni
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1076/010 - 1 x (Kovaltry 3000 IU - solvent (5 mL); pre-filled syringe (5 mL)) 13.
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/15/1076/010 - 1 x (Kovaltry 3000 IU - solvent (5 mL); siringa mimlija għal-lest (5 mL)) 13.
English: Post-authorisation Efficacy Study: In order to investigate the safety and efficacy of long term treatment with Kovaltry, the MAH should submit the results of the ongoing study “13400 - Leopold Kids extension”
Maltese: Sabiex jinvestiga s-sigurtà u l-effikaċja ta' trattament fit-tul b'Kovaltry, l-MAH għandu jissottometti r-riżultati tal-istudju li għaddej bħalissa “13400 - Leopold Kids extension”
English: Allergic type hypersensitivity reactions are possible with Kovaltry.
Maltese: Reazzjonijiet ta' sensittività eċċessiva tat-tip li jikkaġunaw allerġiji huma possibbli b'Kovaltry.
English: A population PK model was developed based on all available factor VIII measurements (from dense PK sampling and all recovery samples) throughout the 3 clinical studies allowing calculation of PK parameters for subjects in the various studies.
Maltese: Mudell PK tal-popolazzjoni ġie żviluppat bbażata fuq il-kejl kollu disponibbli tal-fattur VIII(minn teħid ta' kampjuni PK dens u l-kampjuni ta' rkupru kollha) matul it-3 studji kliniċi li jippermetti kalkolu tal-parametri PK għal individwi fid-diversi studji.
English: Post-authorisation Efficacy Study: In order to investigate the safety and efficacy of Kovaltry in previously untreated patients, the MAH should submit the results of the ongoing study “13400 - Leopold Kids Part B”
Maltese: Sabiex jinvestiga s-sigurtà u l-effikaċja ta' Kovaltry f'pazjenti li ma kinux ittrattati minn qabel, l-MAH għandu jissottometti rriżultati tal-istudju li għaddej bħalissa “13400 - Leopold Kids Part B”
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).
Maltese: Għal tfal li qabel ma kinux ittrattati b'mediċini li fihom il-fattur VIII, antikorpi inibituri (ara sezzjoni 2) jistgħu jiffurmaw b'mod komuni ħafna (iktar minn pazjent 1 minn kull 10).
English: Powder: solid, white to slightly yellow.
Maltese: Trab: solidu, ta' lewn abjad sa kemmxejn fl-isfar.
English: EU/1/15/1076/017 - 30 x (Kovaltry 250 IU - solvent (2.5 mL); pre-filled syringe (3 mL)) EU/1/15/1076/018 - 30 x (Kovaltry 250 IU - solvent (2.5 mL); pre-filled syringe (5 mL))
Maltese: IU - solvent (5 mL); siringa mimlija għal-lest (5 mL)) EU/1/15/1076/010 - 1 x (Kovaltry 3000 IU - solvent (5 mL); siringa mimlija għal-lest (5 mL)) EU/1/15/1076/017 - 30 x (Kovaltry 250
English: Inject the solution into a vein over 2 to 5 minutes, keeping an eye on the position of the needle.
Maltese: Injetta s-soluzzjoni ġo vina fuq perjodu ta' minn 2 sa 5 minuti, waqt li żżomm għajnejk fuq ilpożizzjoni tal-labra.
English: OTHER
Maltese: IU]
English: Now remove and discard the adapter housing (E).
Maltese: Issa neħħi u armi il-kontenitur tal-adapter (E).
English: Kovaltry 500 IU powder and solvent for solution for injection One mL Kovaltry 500 IU contains approximately 200 IU (500 IU / 2.5 mL) of recombinant human coagulation factor VIII (INN: octocog alfa) after reconstitution with water for injections.
Maltese: IU / 2.5 mL) ta' fattur VIII tal-koagulazzjoni umana rikombinanti (INN: octocog alfa) wara r-rikostituzzjoni b'ilma għall-injezzjonijiet.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 3000 IU (octocog alfa) (600 IU/mL after reconstitution).
Maltese: IU (octocog alfa) (600
English: Patients should be informed of the early signs of hypersensitivity reactions including hives, nausea, generalised urticaria, tightness of the chest, wheezing, hypotension, and anaphylaxis.
Maltese: Il-pazjenti għandhom jiġu infurmati dwar is-sinjali bikrija ta' reazzjonijiet ta' sensittività eċċessiva li jinkludu ħorriqija, dardir, urtikarja ġeneralizzata, għafis fis-sider, tħarħar, pressjoni baxxa u anafilassi.
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: Meta l-fattur X ikun attivat, huwa jbiddel prothrombin għal thrombin.
English: EU/1/15/1076/006 - 1 x (Kovaltry 1000 IU - solvent (2.5 mL); pre-filled syringe (3 mL)) EU/1/15/1076/016 - 1 x (Kovaltry 1000 IU - solvent (2.5 mL); pre-filled syringe (5 mL))
Maltese: IU - solvent (2.5 mL); siringa mimlija għal-lest (3 mL)) EU/1/15/1076/016 - 1 x (Kovaltry 1000
English: EU/1/15/1076/021 - 30 x (Kovaltry 1000 IU - solvent (2.5 mL); pre-filled syringe (3 mL)) EU/1/15/1076/022 - 30 x (Kovaltry 1000 IU - solvent (2.5 mL); pre-filled syringe (5 mL))
Maltese: IU - solvent (5 mL); siringa mimlija għal-lest (5 mL)) EU/1/15/1076/024 - 30 x (Kovaltry 3000 IU - solvent (5 mL); siringa mimlija għal-lest (5 mL))
English: EU/1/15/1076/002 - 1 x (Kovaltry 250 IU - solvent (2.5 mL); pre-filled syringe (3 mL)) EU/1/15/1076/012 - 1 x (Kovaltry 250 IU - solvent (2.5 mL); pre-filled syringe (5 mL))
Maltese: IU - solvent (2.5 mL); siringa mimlija għal-lest (3 mL)) EU/1/15/1076/012 - 1 x (Kovaltry 250
English: Kovaltry should be injected intravenously over 2 to 5 minutes depending on the total volume.
Maltese: Kovaltry għandu jingħata permezz ta' injezzjoni fil-vini fuq medda ta' bejn 2 sa 5 minuti skont ilvolum totali.
English: Also factor VIII is an intrinsic protein and not known to cause any reproductive or carcinogenic effects.
Maltese: Ukoll, il-fattur VIII huwa proteina intrinsika u mhux magħruf li jikkawża xi effetti riproduttivi jew karċinoġeniċi.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Kovaltry 3000 IU contains (3000 IU / 5 mL) = 600 IU octocog alfa per mL after reconstitution.
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA(I) Kovaltry 3000 IU fih (3000
English: The chemical and physical in-use stability after reconstitution has been demonstrated for 3 hours at room temperature.
Maltese: L-istabbiltà kimika u fiżika waqt l-użu wara r-rikostituzzjoni ntweriet għal 3 sigħat fit-temperatura talkamra.
English: Peel off the paper cover on the plastic housing of the vial adapter.
Maltese: Qaxxar l-għatu talkarti fuq il-kontenitur tal-plastik tal-adapter tal-kunjett.
English: The reconstituted product must be filtered prior to administration to remove potential particulate matter in the solution.
Maltese: Ma kinux irrappurtati l-ebda każijiet ta' doża eċċessiva.
English: Uncommon (may affect up to 1 in 100 users): allergic reactions including severe sudden allergic reaction dysgeusia (strange taste) urticaria (itchy rash) flushing (redness of the face)
Maltese: L-iktar effetti sekondarji serji huma reazzjonijiet allerġiċi jew reazzjoni allerġika severa.
English: The analysis of all recorded incremental recoveries in previously treated patients demonstrated a median rise of > 2% (> 2 IU/dL) per IU/kg body weight for Kovaltry.
Maltese: L-analiżi ta' kull irkupru inkrementali rreġistrat f'pazjenti kkurati minn qabel uriet żjieda medjana ta' > 2% (> 2 IU/dL) kull IU/kg ta' piż tal-ġisem għal Kovaltry.
English: EU/1/15/1076/004 - 1 x (Kovaltry 500 IU - solvent (2.5 mL); pre-filled syringe (3 mL)) EU/1/15/1076/014 - 1 x (Kovaltry 500 IU - solvent (2.5 mL); pre-filled syringe (5 mL))
Maltese: IU - solvent (2.5 mL); siringa mimlija għal-lest (3 mL)) EU/1/15/1076/014 - 1 x (Kovaltry 500
English: EU/1/15/1076/019 - 30 x (Kovaltry 500 IU - solvent (2.5 mL); pre-filled syringe (3 mL)) EU/1/15/1076/020 - 30 x (Kovaltry 500 IU - solvent (2.5 mL); pre-filled syringe (5 mL))
Maltese: IU - solvent (2.5 mL); siringa mimlija għal-lest (3 mL)) EU/1/15/1076/020 - 30 x (Kovaltry 500
English: Common (may affect up to 1 in 10 users): lymph nodes enlarged (swelling under the skin of the neck, armpit or groin) heart palpitations (feeling your heart beating hard, rapidly, or irregularly) rapid heartbeat stomach pain or discomfort indigestion fever chest pain or discomfort local reactions where you injected the medicine (e.g. bleeding under the skin, intense itching, swelling, burning sensation, temporary redness) headache dizziness trouble falling asleep rash/itchy rash
Maltese: Il-formazzjoni ta' inibituri (antikorpi) hi kumplikazzjoni magħrufa li tista' sseħħ matul il-kura bil-mediċini kollha li fihom Fattur VIII. Dawn l-inibituri, speċjalment f'livelli għoljin, ma jħallux il-kura taħdem kif suppost, u inti jew it-tifel/tifla tiegħek se tiġu sorveljati b'attenzjoni għall-iżvilupp ta' dawn linibituri.
English: Kovaltry is provided as a powder and solvent for solution for injection.
Maltese: Kovaltry huwa disponibbli bħala trab u solvent għal soluzzjoni għall-injezzjoni.
English: NAME OF THE MEDICINAL PRODUCT Kovaltry 2000 IU powder and solvent for solution for injection recombinant human coagulation factor VIII (octocog alfa)
Maltese: IU trab u solvent għal soluzzjoni għall-injezzjoni fattur VIII rikombinanti uman tal-koagulazzjoni (octocog alfa)
English: You will need alcohol swabs, gauze pads, plasters and tourniquet.
Maltese: Se jkollok bżonn ta' imsielaħ bl-alkoħol, gareż, stikk u turnikett.
English: Attach the pre filled syringe to the threaded vial adapter by turning clockwise (F).
Maltese: L-adapter se jikklikkja f'postu fuq l-għatu tal-kunjett.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Kovaltry 3000 IU powder for solution for injection recombinant human coagulation factor VIII (octocog alfa) Intravenous use.
Maltese: U MNEJN GĦANDU JINGĦATA Kovaltry 3000 IU trab għal soluzzjoni għall-injezzjoni fattur VIII rikombinanti uman tal-koagulazzjoni (octocog alfa) Użu għal ġol-vini.
English: If you switch factor VIII products, you may be at risk of your inhibitor coming back.
Maltese: Jekk tbiddel il-prodotti ta' fattur VIII, tista' tkun f'riskju li l-inibitur jerġa' jitfaċċa.
English: Headache, dizziness common
Maltese: Urtikarja mhux komuni
English: to use a central venous access device for the administration of Kovaltry.
Maltese: Istruzzjonijiet dettaljati għar-rikostituzzjoni u l-għoti ta' Kovaltry
English: 1 bottle
Maltese: Flixkun 1
English: Oral use bottle (HDPE)
Maltese: Użu orali flixkun (HDPE) 150 ml
English: Treatment of multiple sclerosis (MS)
Maltese: Kura ta' sklerożi multipla (MS)
English: • The Committee considered the referral under Article 30 of Directive 2001/83/EC.
Maltese: • Il-Kumitat ikkunsidra r-riferiment skont l-Artikolu 30 tad-Direttiva 2001/83/KE.
English: Section 5 - Pharmacological properties
Maltese: Sezzjoni 5 - Proprjetajiet farmakoloġiċi
English: Treatment of non-Hodgkin's lymphoma (NHL)
Maltese: Kura ta' linfoma mhux ta' Hodgkin (NHL)
English: Sections related to the unique identifier were added in line with the current QRD template (dated February 2016).
Maltese: Is-sezzjonijiet relatati mal-identifikatur uniku żdiedu skont ilmudell tal-QRD attwali (data Frar 2016).