FrancophonIA/ELRC3.0 huggingface dataset:
English: INFORMATION IN BRAILLE ADVATE 500
Maltese: INFORMAZZJONI BIL-BRAILLE ADVATE 500
English: Remove the BAXJECT III system from the blister.
Maltese: Neħħi s-sistema BAXJECT III minn ġolfolja.
English: Adjusted Incremental Recovery at Cmax (IU/dL per IU/kg)a
Maltese: Aġġustat f'Cmax (IU/dl għal kull
English: Degree of haemorrhage/type of surgical procedure
Maltese: Grad ta' emorraġija/tip ta' proċedura kirurġika
English: Four of these patients reported isolated events of urticaria, pruritus, rash, and slightly elevated eosinophil counts amongst repeated exposures to the study product.
Maltese: Erbgħa minn dawn il-pazjenti rrapportaw episodji iżolati ta' urtikarja, ħakk, raxx, u livelli daqsxejn għoljin ta' eosinofil fost espożizzjonijiet ripetuti għall-prodott studjat.
English: ADVATE contains recombinant coagulation factor VIII (octocog alfa), a glycoprotein that is biologically equivalent to the factor VIII glycoprotein found in human plasma.
Maltese: ADVATE fih il-fattur VIII tal-koagulazzjoni rikombinanti (octocog alfa), glikoproteina li hi bijoloġikament ekwivalenti għal glikoproteina ta' fattur VIII li tinsab fil-plażma tal-bniedem.
English: If you use more ADVATE than you should
Maltese: Applikazzjoni ħażina ta' ADVATE
English: Possible side effects
Maltese: SEKONDARJI POSSIBBLI
English: Chest discomfort
Maltese: Disturbi vaskulari
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 (IU) waħda tal-attività ta' fattur VIII hija ekwivalenti għal dik il-kwantità ta' fattur VIII f'ml ta' plażma uman normali.
English: Usually, the replacement therapy with ADVATE is a life-long treatment.
Maltese: Ġeneralment it-terapija ta' sostituzzjoni b'ADVATE hija trattament għal tul ħajtek.
English: The plasma levels of factor VIII are increased by replacement therapy, thereby enabling a temporary correction of the factor VIII deficiency and correction of the bleeding tendency.
Maltese: Il-livelli tal-fattur VIII fil-plażma jiżdiedu bit-terapija ta' sostituzzjoni, u b'hekk jippermettu korrezzjoni temporanja għan-nuqqas tal-fattur u l-korrezzjoni tat-tendenza għal fsada.
English: Aseptic technique is required during preparation of the solution and administration.
Maltese: Teknika asettika hija meħtieġa waqt it-tħejjija tas-soluzzjoni u l-amministrazzjoni.
English: Procedural site reaction a) Calculated based on total number of patients who received ADVATE (418).
Maltese: Ikkalkulati msejjes fuq in-numru totali ta' pazjenti li rċivew ADVATE (418).
English: Repeat injections every 8 to 24 hours (6 to 24 hours for patients under the age of 6) until adequate wound healing, then continue therapy for at least another 7 days to maintain a factor VIII activity of 30% to 60% (IU/dl).
Maltese: Irrepeti l-injezzjonijiet kull 8 sa 24 siegħa (6 sa 24 siegħa fil-każ ta' pazjenti li huma taħt is-6 snin) sakemm jinkiseb fejqan adegwat tal-ferita, imbagħad kompli t-terapija għal mill-anqas 7 ijiem oħra biex iżżomm attività tal-fattur VIII ta' 30% sa 60% (IU/dl).
English: ADRs specific to residues from the manufacturing process Of the 229 treated patients who were assessed for antibodies to Chinese hamster ovary (CHO) cell protein, 3 showed a statistically significant upward trend in titres, 4 displayed sustained peaks or transient spikes and one patient had both but no clinical symptoms.
Maltese: ADRs speċifiċi għal residwi mill-proċess tal-manifattura Mill-229 pazjent ikkurat li ġew eżaminati għal antikorpi għall-proteina taċ-ċellula tal-ovarju tal-ħamster Ċiniż (CHO), 3 urew xejra 'l fuq statistikament sinifikanti fit-tajters, 4 urew qċaċet sostenuti jew ponot għaddiena u pazjent wieħed kellu t-tnejn, iżda l-ebda sintomu kliniku.
English: NAME OF THE MEDICINAL PRODUCT ADVATE 2000
Maltese: ADVATE 2000
English: The potency (International Units) is determined using the European Pharmacopoeia chromogenic assay.
Maltese: Il-qawwa (Unitajiet Internazzjonali) hi stabbilita permezz ta' assaġġ kromoġeniku tal-Farmakopoeia Ewropea.
English: Verify that the solvent transfer is complete.
Maltese: Ivverifika li t-trasferiment tas-solvent ikun komplut.
English: Solvent vial: 2 ml sterilised water for injections
Maltese: 2 ml ilma sterilizzat għall-injezzjonijiet.
English: Slight transient reddening at the administration site was observed after intraarterial application and after paravenous administration.
Maltese: Ħmura żgħira temporanja fis-sit minn fejn jingħata ġiet osservata wara applikazzjoni intraarterjali u wara għoti paravenuż.
English: - rash, hives, wheals, generalised itching, - swelling of lips and tongue, - difficulty in breathing, wheezing, tightness in the chest, - general feeling of being unwell, - dizziness and loss of consciousness.
Maltese: - raxx, ħorriqija, pustoli, ħakk ġenerali, - nefħa tax-xofftejn u l-ilsien, - diffikultà biex tieħu n-nifs, tħarħir, is-sider jingħafas, - tħossok ma tiflaħx.
English: NAME OF THE MEDICINAL PRODUCT ADVATE 1500
Maltese: ADVATE 1500
English: Related to central venous access devices (CVAD) catheter-related infection, systemic infection and local blood clot at the catheter site.
Maltese: Infezzjoni assoċjata mal-kateter, infezzjoni sistemika u embolu lokali tad-demm fis-sit tal-kateter.
English: The product contains traces of mouse and hamster proteins.
Maltese: IU/mg proteina.
English: Clearance (ml/kg*h) a Calculated as (Cmax - baseline Factor VIII) divided by the dose in IU/kg, where Cmax is the maximal post infusion Factor VIII measurement.
Maltese: Ikkalkulat bħala (Cmax - Fattur VIII tal-linja bażi) diviż bid-doża f'IU/kg, fejn Cmax huwa l-kejl tal-Fattur VIII wara l-infużjoni massimali.
English: • Do not use after the expiry date stated on the labels and carton.
Maltese: • M'għandekx tuża wara d-data ta' skadenza li tidher fuq it-tikketti u l-kartuna.
English: Older Children (n=18)
Maltese: Tfal ikbar fl-età (n=18)
English: Manufacturers
Maltese: Manifatturi
English: - ADVATE with BAXJECT II device: Each pack contains a powder vial, a vial containing 5 ml solvent and a device for reconstitution (BAXJECT II).
Maltese: - ADVATE mal-istrument BAXJECT II: Kull pakkett fih kunjett tat-trab, kunjett li fih 5 ml solvent u strument għar-rikostituzzjoni (BAXJECT II).
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS ASSEMBLY LABEL (BAXJECT III SYSTEM)
Maltese: TIKKETTA TAL-ASSEMBLY (SISTEMA BAXJECT III)
English: - ADVATE with BAXJECT II device: Each pack contains a powder vial, a vial containing 2 ml solvent and a device for reconstitution (BAXJECT II).
Maltese: - ADVATE mal-istrument BAXJECT II: Kull pakkett fih kunjett tat-trab, kunjett li fih 2 ml solvent u strument għar-rikostituzzjoni (BAXJECT II).
English: For children not previously treated with Factor VIII medicines, inhibitor antibodies (see section 2) may form very commonly (more than 1 in 10 people); 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
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 1 minn kull 10 persuni); madankollu, pazjenti li jkunu rċivew kura b'Fattur VIII fil-passat (aktar minn 150 jum ta' kura), ir-riskju huwa mhux komuni (inqas minn 1 minn kull 100 persuna).
English: NAME OF THE MEDICINAL PRODUCT ADVATE 3000 IU powder and solvent for solution for injection Octocog alfa (recombinant human coagulation factor VIII)
Maltese: ADVATE 3000 IU trab u solvent għal soluzzjoni għall-injezzjoni Octocog alfa (fattur VIII tal-koagulazzjoni umana rikombinanti)
English: The vacuum will draw the solvent into the ADVATE powder vial (Fig. c).
Maltese: Il-vakwu jiġbed is-solvent ġol-kunjett b'ADVATE trab (Fig. ċ).
English: When infused into a haemophilia patient, octocog alfa binds to endogenous von Willebrand Factor in the patient's circulation.
Maltese: Meta jingħata b'infużjoni ġo pazjent b'emofilja, octocog alfa jorbot mal-fattur endoġenu von Willebrand fiċ-ċirkolazzjoni tal-pazjent.
English: Powder: White to off-white friable powder.
Maltese: Waħħal labra farfett mas-siringa.
English: Turn the package over and insert the clear plastic spike through the solvent stopper.
Maltese: Aqleb il-pakkett u daħħal il-ponta iebsa tal-plastik ġot-tapp tas-solvent.
English: Vessel puncture site haematoma
Maltese: Ematoma fis-sit tat-titqib tal-vażi
English: The clinical relevance of inhibitor development will depend on the titre of the inhibitor, with low titre inhibitors which are transiently present or remain consistently 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'inibituri ta' titru baxx li jkunu preżenti temporanjament jew jibqgħu b'titru baxx b'mod konsistenti jkollhom inqas riskju ta' rispons kliniku insuffiċjenti milli minn inibituri b'titru għoli.
English: In the case of major surgical interventions in particular, precise monitoring of the substitution therapy by means of plasma factor VIII activity assay is indispensable.
Maltese: F'każ ta' interventi kirurġiċi maġġuri b'mod partikolari, is-sorveljanza preċiża tat-terapija ta' sostituzzjoni permezz ta' analiżi fuq l-attività tal-fattur VIII fil-plażma hija indispensabbli.
English: - ADVATE in BAXJECT III system: Each pack contains a ready to use BAXJECT III system in a sealed blister (the powder vial and the vial containing 5 ml solvent are preassembled with the system for reconstitution).
Maltese: - ADVATE f'sistema BAXJECT III: kull pakkett jikkonsisti minn sistema BAXJECT III lesta għall-użu f'folja ssiġillata (il-kunjett bit-trab u l-kunjett li fih 5 ml ta' solvent huma mmuntati minn qabel bis-sistema għar-rikostituzzjoni).
English: NAME OF THE MEDICINAL PRODUCT ADVATE 3000 IU powder and solvent for solution for injection Octocog alfa
Maltese: ADVATE 3000 IU trab u solvent għal soluzzjoni għall-injezzjoni Octocog alfa
English: Each powder vial contains nominally 250, 500, 1000, or 1500 IU octocog alfa.
Maltese: Kull kunjett tat-trab nominalment fih 250, 500, 1000, jew 1500
English: Infants (n=5)
Maltese: Tfal żgħar ħafna (n=5)
English: - ADVATE in BAXJECT III system: Each pack contains a ready to use BAXJECT III system in a sealed blister (the powder vial and the vial containing 2 ml solvent are preassembled with the system for reconstitution).
Maltese: - ADVATE f'sistema BAXJECT III: kull pakkett jikkonsisti minn sistema BAXJECT III lesta għall-użu f'folja ssiġillata (il-kunjett bit-trab u l-kunjett li fih 2 ml ta' solvent huma mmuntati minn qabel bis-sistema għar-rikostituzzjoni).
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON (BAXJECT III SYSTEM)
Maltese: TIKKETTA TAL-FOLJA (SISTEMA BAXJECT III)
English: The solution should be administered slowly, at a rate as determined by the patient's comfort level, not to exceed 10 ml per minute.
Maltese: Is-soluzzjoni għandha tiġi amministrata bil-mod, b'rata kif stabilita li jkun komdu biha l-pazjent li ma taqbiżx 10 ml kull minuta.
English: Factor VIII level required (% or IU/dl)
Maltese: Livell ta' fattur VIII mixtieq (% jew IU/dl)
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 and may in some cases progress to severe anaphylaxis (including shock).
Maltese: Sensittività eċċessiva jew reazzjonijiet allerġiċi (li jinkludu anġjoedema, ħruq u tingiż fis-sit tal-infużjoni, tertir ta' bard, ħmura fil-wiċċ, ħakk ġeneralizzat, uġigħ ta' ras, ħorriqija, pressjoni baxxa, letarġija, dardir, irrikwitezza, takikardija, għafis fuq is-sider, tagħrix, rimettar, tħarħir) ġew osservati b'mod rari u fi xi każijiet jistgħu javvanzaw għal anafilassi severa (inkluż xokk).
English: Very common side effects (may affect more than 1 in 10 people) Factor VIII inhibitors (for children not previously treated with Factor VIII medicines).
Maltese: Effetti sekondarji komuni ħafna (jistgħu jaffettwaw aktar minn 1 minn kull 10 persuni) Impedituri ta' Fattur VIII (għat-tfal li ma kinux ikkurati fil-passat b'mediċini li fihom Fattur VIII).
English: All pharmacokinetic studies with ADVATE were conducted in previously treated patients with severe to moderately severe haemophilia A (baseline factor VIII ≤ 2%).
Maltese: L-istudji farmakokinetiċi kollha b'ADVATE saru f'pazjenti li kienu trattati qabel għal emofilja A severa jew moderatament severa (linja bażi ta' riferiment ta' fattur VIII ≤ 2%).
English: Adjusted recovery and terminal half-life (t½) was approximately 20% lower in young children (less than 6 years of age) than in adults, which may be due in part to the known higher plasma volume per kilogram body weight in younger patients.
Maltese: L-irkupru aġġustat u l-half-life terminali (t½) kienu madwar 20% aktar baxxi fi tfal żgħar (ta' inqas minn 6 snin) milli fl-adulti, li jista' jkun dovut parti għal volum akbar magħruf tal-plażma għal kull kilogramm ta' piż tal-ġisem f'pazjenti iżgħar.
English: Instructions for preparation and administration Aseptic technique is required during preparation of the solution and administration.
Maltese: Istruzzjonijiet għall-preparazzjoni u l-amministrazzjoni
English: Connect the syringe to BAXJECT III.
Maltese: Neħħi s-sistema BAXJECT III minn ġol-folja.
English: Related to surgery catheter-related infection, decreased red cell blood count, swelling of limbs and joints, prolonged bleeding after drain removal, decreased Factor VIII level and post-operative bruise.
Maltese: Relatati ma intervent kirurġiku infezzjoni relatata mal-kateter, tnaqqis fl-għadd ta' ċelloli ħomor fid-demm, nefħa fir-riġlejn u d-dirgħajn u fil-ġogi, fsada mtawla wara li jitneħħa l-pajp li minnu jgħaddi l-likwidu li joħroġ mill-ferita, tnaqqis fil-livell ta' Fattur VIII u tbenġil wara l-operazzjoni.
English: Specific activity: approx. 4,000 - 10,000 IU/mg protein
Maltese: Attività speċifika: madwar 4,000 - 10,000
English: The following table 2 provides the frequency of adverse drug reactions in clinical trials and from spontaneous reporting.
Maltese: It-tabella 2 li ġejja tipprovdi l-frekwenza ta' reazzjonijiet avversi għall-mediċina fi provi kliniċi u minn rappurtaġġ spontanju.
English: Can be stored at room temperature (up to 25 °C) for a single period up to 6 months.
Maltese: Jista' jinħażen fit-temperatura tal-kamra (sa 25°C) għal perjodu wieħed sa 6 xhur.
English: The frequency of administration will depend on how well ADVATE is working for you.
Maltese: Il-frekwenza ta' amministrazzjoni ser tiddependi kemm ADVATE ikun qed jaħdem tajjeb għalik.
English: Each vial contains nominally 500 IU human coagulation factor VIII (rDNA), octocog alfa.
Maltese: IU ta' fattur VIII tal-koagulazzjoni tal-bniedem (rDNA), octocog alfa.
English: In case of shock, standard medical treatment for shock should be implemented.
Maltese: F'każ ta' xokk, għandha tiġi implimentata l-kura medika standard għal xokk.
English: Each vial contains nominally 3000 IU human coagulation factor VIII (rDNA), octocog alfa.
Maltese: Ġeneralment kull kunjett fih 3000 IU ta' fattur VIII tal-koagulazzjoni tal-bniedem (rDNA), octocog alfa.
English: How to store ADVATE
Maltese: Tfal u adolexxenti
English: NAME OF THE MEDICINAL PRODUCT ADVATE 250
Maltese: ADVATE 250
English: Development of inhibitors is a known complication in the treatment of haemophilia A. If your bleeding is not controlled with ADVATE, tell your doctor immediately.
Maltese: Reazzjonijiet ta' sensittività eċċessiva tat-tip allerġiku, li jinkludu anafilassi, ġew irrappurtati b'ADVATE.
English: After reconstitution, the solution is clear, colourless, free from foreign particles and has a pH of 6.7 to 7.3.
Maltese: Wara rikostituzzjoni, is-soluzzjoni hija ċara, bla kulur, ħielsa minn frak barrani u għandha pH ta' 6.7 sa 7.3.
English: NAME OF THE MEDICINAL PRODUCT ADVATE 3000
Maltese: ADVATE 3000
English: ADVATE in BAXJECT III system: Keep the sealed blister in the outer carton in order to protect from light.
Maltese: ADVATE f'sistema BAXJECT III: Żomm il-folja ssiġillata fil-kartuna ta' barra sabiex tilqa' mid-dawl.
English: Haematoma
Maltese: Ematoma
English: NAME OF THE MEDICINAL PRODUCT ADVATE 1000
Maltese: ADVATE 1000
English: Both the powder vial and the vial containing 5 ml solvent are of type I glass closed with chlorobutyl rubber stoppers.
Maltese: Kemm il-kunjett bit-trab kif ukoll il-kunjett li fih 5 ml ta' solvent huma ta' ħġieġ ta' tip I magħluqin b'tappijiet tal-lastku chlorobutyl.
English: PHARMACEUTICAL FORM AND CONTENTS Powder and solvent for solution for injection Contents: 1 vial with 3000 IU octocog alfa, 1 vial with 5 ml sterilised water for injections, 1 BAXJECT II device.
Maltese: U KONTENUT Trab u solvent għal soluzzjoni għall-injezzjoni Kontenut: 1 kunjett bi 3000 IU ta' octocog alfa, 1 kunjett b'5 ml ta' ilma sterilizzat għallinjezzjonijiet, 1 strument BAXJECT II.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER LABEL (BAXJECT III SYSTEM)
Maltese: Ż-ŻGĦAR EWLENIN TIKKETTA TAL-KUNJETT GĦAS-SOLVENT (SISTEMA BAXJECT III)
English: Due to the decrease in injection volume for ADVATE reconstituted in 2 ml, the time to react to hypersensitivity reactions during an injection is further reduced.
Maltese: Minħabba t-tnaqqis fil-volum tal-injezzjoni għal ADVATE rikostitwit f'2 ml, il-ħin biex tirreaġixxi għal reazzjonijiet ta' sensittività eċċessiva waqt injezzjoni jitnaqqas b'mod addizzjonali.
English: Half-life (h)
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I)
English: Coagulation factor VIII level decreasedb
Maltese: Effetti sekondarji addizzjonali fit-tfal
English: Of the 229 treated patients who were assessed for antibodies to murine IgG, 10 showed a statistically significant upward trend, 2 displayed a sustained peak or transient spike and one patient had both.
Maltese: Mill-229 pazjent kkurat li ġew eżaminati għal antikorpi għall-IgG tal-ġrieden, 10 urew xejra 'l fuq statistikament sinifikanti, 2 urew quċċata sostnuta jew ponta għaddiena u pazjent wieħed kellu t-tnejn.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/03/271/006
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/03/271/006
English: Individual patients may vary in their response to factor VIII, achieving different levels of in vivo recovery and demonstrating different half-lives.
Maltese: Pazjenti individwali jista' jkollhom reazzjoni differenti għall-fattur VIII, jilħqu livelli differenti ta' irkupru in vivo u juru half lives differenti.
English: PHARMACEUTICAL FORM AND CONTENTS Powder and solvent for solution for injection Contents: 1 vial with 3000 IU octocog alfa and 1 vial with 5 ml sterilised water for injections preassembled in BAXJECT III system.
Maltese: U KONTENUT Trab u solvent għal soluzzjoni għall-injezzjoni Kontenut: 1 kunjett bi 3000 IU ta' octocog alfa u 1 kunjett b'5 ml ta' ilma sterilizzat għallinjezzjonijiet immuntati minn qabel f'sistema BAXJECT III.
English: PHARMACEUTICAL FORM AND CONTENTS Powder and solvent for solution for injection Contents: 1 vial with 250 IU octocog alfa, 1 vial with 2 ml sterilised water for injections, 1 BAXJECT II device.
Maltese: U KONTENUT Trab u solvent għal soluzzjoni għall-injezzjoni Kontenut: 1 kunjett b'250 IU ta' octocog alfa, 1 kunjett b'2 ml ta' ilma sterilizzat għallinjezzjonijiet, 1 strument BAXJECT II.
English: Fig. e
Maltese: Fig. ċ
English: Life threatening haemorrhages.
Maltese: Disturbi ġenerali u kondizzjonijiet ta' mnejn jingħata
English: ADVATE must not be mixed with other medicinal products or solvents.
Maltese: ADVATE m'għandux jitħallat ma prodotti mediċinali oħra jew solventi.
English: Haemorrhage Early haemarthrosis, muscle bleeding or oral bleeding.
Maltese: Emoartrożi aktar estensiva, emorraġija fil-muskoli jew ematoma.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/03/271/008
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/03/271/008
English: During the shelf life the powder vial may be kept at room temperature (up to 25 °C) for a single period not exceeding 6 months.
Maltese: Jista' jinħażen f'temperatura ambjentali (sa 25 °C) għal perjodu wieħed ta' mhux aktar minn 6 xhur.
English: For long-term prophylaxis against bleeding in patients with severe haemophilia A, the usual doses are 20 to 40 IU of factor VIII per kg body weight at intervals of 2 to 3 days.
Maltese: Għal profilassi fit-tul kontra l-emorraġija f'pazjenti b'emofilja A severa, id-dożi li ġeneralment jingħataw huma 20 sa 40 IU ta' fattur VIII għal kull kg ta' piż tal-ġisem f'intervalli ta' 2 jew 3 ijiem.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/03/271/005
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/03/271/005
English: Both the powder vial and the vial containing 2 ml solvent are of type I glass closed with chlorobutyl rubber stoppers.
Maltese: Kemm il-kunjett bit-trab kif ukoll il-kunjett li fih 2 ml ta' solvent huma ta' ħġieġ ta' tip I magħluqin b'tappijiet tal-lastku chlorobutyl.
English: PHARMACEUTICAL FORM AND CONTENTS Powder and solvent for solution for injection Contents: 1 vial with 1000 IU octocog alfa, 1 vial with 2 ml sterilised water for injections, 1 BAXJECT II device.
Maltese: U KONTENUT Trab u solvent għal soluzzjoni għall-injezzjoni Kontenut: 1 kunjett b'1000 IU ta' octocog alfa, 1 kunjett b'2 ml ta' ilma sterilizzat għallinjezzjonijiet, 1 strument BAXJECT II.
English: ADVATE contains approximately 250 IU per ml of human coagulation factor VIII (rDNA), octocog alfa after reconstitution.
Maltese: IU kull ml ta' fattur VIII tal-koagulazzjoni tal-bniedem (rDNA), octocog alfa wara r-rikostituzzjoni.
English: Grip the package at its edge and pull the package off BAXJECT II (Fig. b).
Maltese: Aqbad il-pakkett mit-tarf tiegħu u iġbed il-pakkett minn fuq BAXJECT II (Fig. b).
English: PHARMACEUTICAL FORM AND CONTENTS Powder and solvent for solution for injection Contents: 1 vial with 1500 IU octocog alfa, 1 vial with 2 ml sterilised water for injections, 1 BAXJECT II device.
Maltese: U KONTENUT Trab u solvent għal soluzzjoni għall-injezzjoni Kontenut: 1 kunjett b'1500 IU ta' octocog alfa, 1 kunjett b'2 ml ta' ilma sterilizzat għallinjezzjonijiet, 1 strument BAXJECT II.
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 to thrombin.
Maltese: Il-fattur VIII attivat jaħdem bħala Ko-fattur għall-Fattur IX attivat, jaċċellera l-bdil ta' Fattur X għal Fattur X attivat.
English: Hypersensitivity c
Maltese: GĦAMLA KWALITATTIVA
English: NAME OF THE MEDICINAL PRODUCT ADVATE 2000 IU powder and solvent for solution for injection Octocog alfa (recombinant human coagulation factor VIII)
Maltese: IU trab u solvent għal soluzzjoni għall-injezzjoni Octocog alfa (fattur VIII tal-koagulazzjoni umana rikombinanti)
English: For on demand treatment dosing in paediatric patients (0 to 18 years of age) does not differ from adult patients.
Maltese: Għal trattament fuq talba, id-dożaġġ f'pazjenti pedjatriċi (0 sa 18-il sena) mhuwiex differenti minn dak ta' pazjenti adulti.
English: A central venous access device (CVAD) may become necessary to allow frequent infusions of factor VIII products.
Maltese: Tagħmir għal aċċess venuż ċentral (CVAD) jista' jsir neċessarju biex jippermetti infużjonijiet frekwenti ta' prodotti ta' fattur VIII.
English: If central venous access device (CVAD) is required, risk of CVAD-related complications including local infections, bacteremia and catheter site thrombosis should be considered.
Maltese: Jekk it-tagħmir għal aċċess venuż ċentrali (CVAD) hu meħtieġ, ir-riskju ta' kumplikazzjonijiet relatati ma' CVAD li jinkludu infezzjonijiet lokali, batteremija u trombożi fis-sit tal-kateter, għandhom jiġu kkunsidrati.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/03/271/007
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/03/271/007
English: MARKETING AUTHORISATION NUMBER(S) EU/1/03/271/002
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/03/271/002