FrancophonIA/ELRC3.0 huggingface dataset:
English: Mean steady state clearance is 24 ml/kg/day (range 5-76 ml/kg/day) at 1 mg/kg/ week subcutaneous.
Maltese: Il-valur medju ta' l-eliminazzjoni fiss huwa 24ml.kg/ġurnata (firxa ta' 5-76 ml/kg/ġurnata) għal 1mg/kg/ġimgħa doża taħt il-ġilda.
English: • Common: Side effects that may occur in 1 to 10 out of 100 patients;
Maltese: • Komuni: effetti oħra li jistgħu jseħħu fi 1-10 pazjienti minn 100;
English: The metabolism of efalizumab is through internalisation followed by intracellular degradation as a consequence of either binding to cell surface CD11a or through endocytosis.
Maltese: Il-metaboliżmu ta' efalizumab huwa permess ta' internalisation issegwit minn intracellular degradation bħala konsegwenza jew ta' rabta ma' wiċċ tal-ċellula CD11a jew ta' endoċitosi.
English: No lymphomas were observed following 6 months treatment with an antibody analogue of efalizumab in a 6 months study with p53 +/+ wild type mice.
Maltese: Ma kienux osservati limfomas 6 xhur wara kura ma analogu ta' l-antikorpju ta' efalizumab fi studju ta' 6 xhur ma' p53+/+ wild type ġrieden.
English: - If you have active tuberculosis or other severe infections.
Maltese: Pazjienti b' tuberkulosi attiva u infezzjonijiet severi oħrajn.
English: Packs of 1 vial of powder, 1 pre-filled syringe of solvent, 1 EasyMIX adapter for reconstitution and Packs of 4 vials of powder, 4 pre-filled syringes of solvent, 4 EasyMIX adapters for reconstitution and Packs of 12 vials of powder, 12 pre-filled syringes of solvent, 12 EasyMIX adapters for reconstitution
Maltese: EasyMIX adaptors għal rikostituzzjoni , 4 labar oħra għall-injezzjoni u pakketti ta' 12 vjali ta' trab, 12 siringi mimlijien lesti għal l-użu ta' solvent, 12 EasyMIX adaptors għal rikostituzzjoni u 12 labar għall
English: The largest study IMP24011 (n=793) included patients (n=526) who were not controlled by, contraindicated to, or intolerant to two or more systemic therapies as judged from the patients' histories of psoriasis treatment.
Maltese: L-akbar studju IMP24011 (n=793) inklu\a pazjienti (n=526) li ma kienux kontrollati minn, ma kienux kontra-indikati għal, jew intoleranti għal tnejn jew aktar terapji sistemiċi kif inhu ġġudikat mill-passat tal-kura għal
English: • The active substance is efalizumab, each vial contains a deliverable dose of 125 mg efalizumab.
Maltese: • Is-sustanza attiva hi efalizumab, kull vjala fiha doża li jista' jingħata ta' 125mg efalizumab.
English: • Holding the EasyMIX outer cover, place it on top of the vial, then press down so that the plastic spiked end pierces the rubber stopper on the vial.
Maltese: • Zomm il-kisi ta' barra tal-EasyMIX, poggija fuq il-vjala, u ghafas l-isfel sabiex il-bicca plastic ippuntata ttaqqab l-istopper tal-gomma fuq il-vjala.
English: Cytochrome P450 enzymes as well as conjugation reactions are not involved in the metabolism of
Maltese: L-enżimi Cytochrom P450, kif ukoll reazzjonijiet ta' konġugazzjoni mhumiex involuti fil-metaboliżmu ta' efalizumab.
English: • The other ingredients are polysorbate 20, histidine, histidine hydrochloride monohydrate and
Maltese: • Is-sustanzai l-oħra huma polysorbat 20, histidine, histidine hydrochloride monohydrate u
English: Dosing for adults (18-64 years) and the elderly (≥ 65 years) The usual dose is an initial single injection of 0.7 mg/kg followed by weekly injections of 1.0 mg/kg.
Maltese: Doża għal adulti (18-64 snin) u l-anżjani (≥ 65 sena) Id-doża li ssoltu tingħata bħala injezzjoni iniżjali singolari hija ta' 0.7mg/kg issegwit minn injezzjonijiet ta' kull ġimgħa ta' 1.0mg/kg.
English: A MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE AND
Maltese: TAS-SUSTANZA BIJOLOĠIKA ATTIVA
English: • Rare: Side effects that may occur in 1 to 10 out of 10,000 patients;
Maltese: • Rari: effetti oħra li jistgħu jseħħu fi 1-10 pazjienti minn 10,000;
English: At the 1 mg/kg/wk dose level (with an initial dose of 0.7 mg/kg the first week), mean efalizumab plasma trough values were 11.1±7.9 µg/ml.
Maltese: Fil-livell ta' 1mg/kg/ġimgħa (b'doża iniziali ta' 0.7mg/kg l-ewwel ġimgħa), il-valuri medji l-aktar baxxi ta' efalizumab fil-plażma kienu 11.1±7.9 µg/ml.
English: Within 5 to 8 weeks following the 12th and final dose of efalizumab administered at 1.0 mg/kg/wk, CD11a levels returned to within a range of ±25% of baseline values.
Maltese: Fi 5-8 ġimgħat wara it-12 ‘l-doża and l-aħħar doża ta efalizumab amministrat ta' 1.0mg/kg/ġimgħa, il-livelli ta' CD11a reġgħu ritornaw fil-firxa ta' ±25% tal-valuri tal-linea basi.
English: LFA-1 is present on activated T lymphocytes, and ICAM-1 is up-regulated on endothelial cells and keratinocytes in psoriasis plaques.
Maltese: LFA-1 huwa presenti fuq T-limfoċiti, u ICAM-1 huwa jiżdied fuq iċ-ċelluli endothelial u keratinoċiti fi plakki ta' psorjażi.
English: The elimination half-life was about 5.5-10.5 days at 1 mg/kg/ week subcutaneous.
Maltese: Il half-life tal-eliminazzjoni kien ta' madwar 5.5-10.5 ġranet għal doża ta' 1mg/kg/ġimgħa.
English: The present results of Raptiva versus placebo over 12 weeks of treatment with different populations indicate a PASI 75 response to Raptiva in 22% to 39% of patients (see Table 2).
Maltese: Ir-riżultati t'issa ta' Raptiva kontra plaċebo f'12-il ġimgħa ta kura f'populazzjonijiet differenti juru PASI 75 respons għal Raptiva f'22% sa 39% ta pazjienti (ara Medja 2).
English: Primary Endpoint: Proportion of Subjects with ≥75% improvement in PASI after 12 weeks of Treatment (PASI 75)
Maltese: Mejda 1 Puntu ta' l-a]]ar Primarja: Proporzjoni ta' Pazjienti bi titjieba ta' ≥75% improvement fi PASI wara 12-il ġimgħa ta' kura (PASI 75)
English: JC virus infection resulting in PML has been reported in post-marketing surveillance in a patient with psoriasis receiving Raptiva (see section 4.4).
Maltese: Infezzjoni tal-JC virus riżultanti fil-PML ġiet irrapurtata waqt sorveljanza wara t-tqegħid fis-suq, f'pazjenti li jsofru bil-psorijasi u li kienu qed jieħdu r-Raptiva (ara sezzjoni 4.4).
English: Following booster vaccination with tetanus toxoid (recall antigen), the ability to mount an immune response to the tetanus toxoid was preserved in those patients undergoing Raptiva therapy.
Maltese: Wara tilqima rafforzanti tat-toxoid tat-tetanu (recall antiġen), il-kapaċita' sabiex tibni risposta immuna għal din it-toxoid tat-tetanu kienet preservata f'dawk il-pazjienti taħt kura ma'
English: In the combined safety database of 3291 Raptiva-treated patients at the time of approval, there were nine occurrences (0.3%) of thrombocytopenia with less than 52,000 cells per μl reported.
Maltese: F'database ikkombinat tas-sigurta' ta' 3291 pazjienti taħt il-kura b'Raptiva fiz-żmien ta l'approvazzjoni, kien hemm 9 ġrajjiet ta tromboċitopenja ma' inqas minn 52,000 ċelluli/μl irraportat.
English: Data from extended treatment (more than 12 weeks) have been obtained from 4311 patients in open label uncontrolled studies.
Maltese: Informazzjoni taż-żmien twil (iktar minn 12 ġimgħat) kienu kisbien minn 4311 pażjienti f'istudju ‘open label' mhux ikkontrollat.
English: Raptiva is a medicine containing efalizumab, made by means of biotechnology.
Maltese: Raptiva huwa mediċina li fiha efalizumab, li huwa magħmul permezz ta' bioteknoloġija.
English: In large placebo-controlled clinical studies, approximately 20% of patients in excess of placebo reported flu-like symptoms including headaches, chills, fever, nausea and myalgia.
Maltese: Fi studji kliniċi kbar ikkontrollati minn plaċebo, madwar 20% ta pazjienti iktar minn plaċebo rrapurtaw simptomi bħal ta' l-influenza inkluż uġigħ ta' ras, sirdat, deni, nawsea u mjalġja.
English: • Uncommon: Side effects that may occur in 1 to 10 out of 1,000 patients;
Maltese: • Mhux komuni: effetti oħra li jistgħu jseħħu fi 1-10 pazjienti minn 1,000;
English: See section 4.8 regarding the effects on the hepatic function.
Maltese: Ara sezzjoni 4.8 fuq l-effetti fuq il-fwied.
English: In a study of 66 patients with moderate plaque psoriasis, immune responses during and after Raptiva treatment were investigated.
Maltese: F'studju ta' 66 pazjienti b'psorjażi plaque moderata, ġew investigati r-risposti immuni waqt u wara lkura ma' Raptiva.
English: Reconstitution with the solvent yields a solution containing efalizumab at 100 mg/ml.
Maltese: Rikosstituzzjoni ma' is-solvent jagħti soluzzjoni ta' 100mg/ml ta' efalizumab.
English: • Holding the EasyMIX outer cover, carefully peel back and remove the protective film using the tab.
Maltese: • Zomm il-kisi ta barra tal-EasyMIX, u bil-mod aqla il-kisi protettiv billi tuza it-tab.
English: As with any recombinant product, Raptiva is potentially immunogenic.
Maltese: Bħal ma kull prodott rikombinat, Raptiva huwa potenzjalment immunogenic.
English: Measurements of volume of distribution of the central compartment after single intravenous doses were 110 ml/kg at dose 0.03 mg/kg and 58 ml/kg at dose 10 mg/kg.
Maltese: 03mg/kg u 58ml/kg fi doża ta' 10mg/kg.
English: In all studies, the primary endpoint was the proportion of patients with a ≥ 75% improvement in the Psoriasis Area and Severity Index score (a PASI 75 response) relative to baseline when assessed one week after a 12-week treatment course.
Maltese: Fl-istudji kollha, il-puntu ta' l-aħħar primarja kien il-proporzjoni ta' pazjienti bi titjieba ta' ≥ 75% fil Psoriasis Area and Severity Index score ( PASI 75 risposta), relattata mal-linea ta' basi, meta ġie ezaminat ġimgħa wara kors ta' kura ta' 12-il ġimgħa.
English: (n=369) b (n=162) b (n=232) b (n=450) b (n=529) b a
Maltese: (n=369) b (n=162) b (n=232) b (n=450) b (n=529) b IMP24011: p-values ikkomparaw efalizumab ma' plaċebo bl-użu ta' logistic regression, inkluz linea ta' basi PASI score, kura li ntuża qabel għal psorjażi, u reġjun ġeografiku bħal covariates.
English: 12 vials of powder for solution for injection.
Maltese: 12 vjali ta' trab għal soluzzjoni għall-injezzjoni.
English: Reconstitution of the singleuse vial with 1.3 ml of the supplied water for injections yields approximately 1.5 ml of solution to deliver 100 mg per 1 ml of Raptiva.
Maltese: Rikostituzzjoni tal-vjala ta' użu singolari ma' 1.3ml ta' l-ilma għal injezzjoni li huwa xxuplit, jagħti madwar 1.5ml ta' soluzzjoni sabiex jagħti 100mg/1ml ta' Raptiva.
English: - You might get infections more easily.
Maltese: Jista jkollhok infezzjonijiet aktar faċilment.
English: Adverse events (Preferred Terms) in the overall population studied clinically with Raptiva are listed below by frequency of occurrence and by MedDRA System Organ Class.
Maltese: Effetti avversi fuq il-populazzjoni ġenerali li fuqu ġie studjat Raptiva, huma mmniżżla taħt, f'ordni ta' frekwenża u mil MedDRA System Organ Class.
English: It has the potential to increase the risk or the severity of infections, e.g. tuberculous pneumonia, and reactivate latent, chronic infections e.g. JC virus infection.
Maltese: Għandu l-potenzjal illi jiżdied irriskju jew is-severita' ta' infezzjonijiet, e.g. pnewmonja tuberkulosi, u jerġa jattiva infezzjonijiet
English: Animal studies indicate an impairment of the immune function of the offspring (see section 5.3).
Maltese: Studji li saru fl-annimali juru li jkun hemm indeboliment tal-funzjoni immuna taz-zgħar (ara sezzjoni 5.3).
English: The median time to relapse among PASI responders ranged from 58 to 74 days following the last Raptiva dose in the initial treatment period.
Maltese: Iż-żmien medju sakemm terġa toħroġ il-marda fost il- PASI responders kien bejn 58 - 74 -il ġurnata wara l-aħħar doża ta' Raptiva, fil-perijodu iniziali tal-kura.
English: Efalizumab shows dose-dependent nonlinear pharmacokinetics which can be explained by its saturable specific binding to cell surface receptors CD11a.
Maltese: Efalizumab juri farmakokinetika li hija nonlinear, doża-dipendenti li jista' jiġi mifthemi mir-rabta spe1ifika saturata ma' riċetturi fil-wiċċ taċ-ċelluli CD11a.
English: For this purpose the following classification has been used:
Maltese: Għalhekk is-segwenti klassikazzjoni intuża:
English: Over long term treatment, the frequency of hypersensitivity-related adverse events did not increase.
Maltese: F'kura għal tul ta' żmien, ilfrekwenza ta effetti avversi minħabba ipersensitivita ma żdietx.
English: Efalizumab does not cross-react with CD11a from species other than humans and chimpanzees.
Maltese: Efalizumab ma jagħmilx cross-reaction ma CD11a minn species oħrajn barra minn umani u ċimpanzi.
English: In large placebo-controlled clinical studies, these reactions were observed in approximately 41% of Raptiva-treated patients and 24% in placebo-treated patients over 12 weeks of treatment.
Maltese: F'studji kliniċi kbar, kontrollati minn plaċebo, dawn ir-reazzjonijiet ġew osservati f'approssimattiv ta' 41% ta' pazjienti fuq Raptiva u 24% ta' pazjienti fuq plaċebo, li ħadu l-kura fuq 12 ġimgħat.
English: The effect of renal or hepatic impairment on the pharmacokinetics of efalizumab has not been studied.
Maltese: Inkella, l-effetti osservati fi studji mhux kliniċi jistgħu jkunu rrelatati mal-farmakoloġija ta' efalizumab.
English: At a dose of 1.0 mg/kg/wk subcutaneous efalizumab, lymphocyte levels returned to within 10% of baseline by 8 weeks post last dose.
Maltese: B'doża ta' 1.0mg/kg/ġimgħa efalizumab li jingħata taħt il-ġilda, il-livelli tal-limfoċiti reġa' nizel għal 10% tal-linea basi sat-8 ġimgħa wara l-aħħar doża.
English: In placebo controlled clinical trials, the overall incidences of malignancy (the majority of which were non-melanoma skin cancers) were similar in Raptiva-treated patients and in placebo-treated patients.
Maltese: Fi studji kliniċi kontrollati minn plaċebo, fuq kollox, ir-rata ta' malinni (il-maġorita' ta min kienu nonmelanoma kanċer tal-ġilda) kienu simili f'pazjienti fuq Raptiva u pazjienti fuq plaċebo.
English: 4 vials of powder for solution for injection.
Maltese: 4 vjali ta' trab għal soluzzjoni għall-injezzjoni.
English: The safety and efficacy of Raptiva in moderate to severe plaque psoriasis patients has been demonstrated in five randomized, double-blind, placebo-controlled trials at the recommended dose (n=1742).
Maltese: Is-sigurta' u l-effikaċja ta' Raptiva f'pazjienti bi psorjażi plaque moderata - severa, ġie demonstrat f'ħames studji randomised, double-blind, kontrollati minn plaċebo, bid-doża rakkomandat.
English: After 35 days of treatment with Raptiva, the proportion of subjects treated with efalizumab with positive skin test reactions to Candida was significantly reduced compared with the placebo group.
Maltese: Wara 35 tjiem ta' kura ma' Raptiva, dawk il-pazjienti ttratati ma' efalizumab li kellhom test tal-ġilda positiva għal Candida kienet fhem imnaqqsa meta kkomparata mal-grupp li kienu fuq plaċebo.
English: In study IMP24011, approximately half of the patients (46.8%) who were partial responders (50% to 74% improvement on PASI, similar to PGA good) after 12 weeks of Raptiva treatment achieved a PASI 75 response at week 24.
Maltese: Fl-istudju IMP24011, madwar nofs mil pazjienti (46.8%) li kienu responders parzjali (50% sa 74%
English: The volume to be injected
Maltese: U KWANTITATTIVA
English: In the first 12 weeks of placebo-controlled studies, arthritis and exacerbation or flare of arthritis were observed in 1.8% of Raptiva-treated patients and placebo-treated patients.
Maltese: Fl-ewwel 12-il ġimgħa ta' l-istudji kontrollati minn plaċebo, artrite u artrite li ssir għar kien osservat fi 1.8% ta' pazienti taħt il-kura ta' Raptiva u taħt il-kura ta' plaċebo.
English: Name and address of the manufacturer(s) of the biological active substance Genentech, Inc.
Maltese: Isem u indirizz tal-manifattur(i) tas-sustanza bijoloġika attiva
English: Patients must be monitored at regular intervals for any new or worsening neurological symptoms or signs that may be suggestive of PML (such as impaired cognition, visual disturbances, hemiparesis, altered mental state or behavioural changes).
Maltese: Pazjenti għandhom jiġu monitorjati f'intervalli regolari għal sintomi ġodda jew sintomi newroloġiċi li jkunu qed jiħżienu jew sinjali li jistgħu jkunu qed jindikaw il-PML (bħal konoxxibilita' mgħarrqa, disturbi viżwali, ħemipareżi, bdil fl-istat mentali u bidliet komportamentali).
English: Volume to be injected per 10 kg body weight 0.07 ml
Maltese: Volum li jrid jingħata/ 10kg piż tal-ġisem 0.07 ml
English: Given the mechanism of action of efalizumab, its effects on the immune system may be potentiated by systemic immunosuppressives commonly used for the treatment of psoriasis (see section 4.4).
Maltese: Minħabba l-mod ta' kif jaħdem efalizumab, l-effetti tiegħu fuq is-sistema immune jista' jiġi potenzjat minn immunosuppressives sistemiċċ,li jintuzaw ta' spiss għal-kura ta' psorjażi (ara sezzjoni 4.4).
English: PACKAGE LEAFLET: INFORMATION FOR THE USER Raptiva 100 mg/ml powder and solvent for solution for injection Efalizumab
Maltese: INFORMAZZJONI GĦAL MIN QED JAGĦMEL UŻU MINNHA Raptiva 100 mg/ml trab u solvent għal soluzzjoni għall-injezzjoni Efalizumab
English: Time to relapse (≥50% loss of improvement) was evaluated in Study ACD2058g and IMP 24011 for patients who were classified as responders (≥75% improvement on PASI) after 12 weeks of treatment.
Maltese: Iż-żmien sakemm terġa toħroġ il-marda (≥50% nuqqas ta' miljorament) kien evaluat fl-Istudju ACD2058g u IMP 24011 għal pazjienti li ġew ikklassifikati bħal responders (≥ 75% miljorament fuq il PASI) wara 12-il ġimgħa ta' kura.
English: Each vial contains a retrievable amount of 125 mg of efalizumab.
Maltese: Fjala waħda fiha ammont li jista' jitneħħa ta' 125mg ta' efalizumab.
English: Approximately half of the patients treated for more than 1 year were PASI 75 responders (when all dropouts were considered as non-responders).
Maltese: Madwar nofs il-pazjienti taħt il-kura għal aktar minn sena kienu PASI 75 responders (meta dawk kollha li twaqqfu kienu ikkonsidrati bħala nonresponders).
English: NAME OF THE MEDICINAL PRODUCT Raptiva 100 mg/ml powder and solvent for solution for injection
Maltese: Raptiva 100 mg/ml trab u solvent g]al soluzzjoni għall-injezzjoni
English: Pihatörmä 1 C FI-02240 Espoo Puh/Tel: +358-9-8678 700
Maltese: FI-02240 Espoo Puh/Tel:
English: Your doctor will advise you what to do when insufficient response to treatment or worsening of your disease is observed.
Maltese: Dan jista' jkun assoċjat ma' risposta inqas jew inadeguata meta tikkompara ma' kuri li ttieħdu qabel.
English: In a clinical study, where subjects were exposed to higher doses of efalizumab (up to 10 mg/kg intravenous), one subject receiving 3 mg/kg intravenous dose experienced hypertension, chills, and fever on the day of study drug dosing, which required hospitalization.
Maltese: Fi studju kliniku, fejn is-suġġetti kienu esposti għad-doza għola ta' efalizumab (sa' 10mg/kg ġol vina), suġġet wieħed li rrċieva doza ta' 3mg/kg fil-vina, esperjienza ipertensjoni, sirdat u deni fil-ġurnata taddoza tal-droga għall-istudju, li kellhu bżonn li jidħol l-isptar.
English: By preventing LFA-1/ICAM binding, efalizumab may alleviate signs and symptoms of psoriasis by inhibiting several
Maltese: Meta jiġi pprevenut ir-rabta LFA-1/ICAM, efalizumab jista' jonqos is-sinjali u s-simptomi ta' psorjażi billi jipprevieni ċerti passi
English: MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH
Maltese: TAS-SUSTANZA BIJOLOĠIKA ATTIVA U DETENTUR (I) TA' LAWTORIZZAZZJONI
English: The pharmacokinetics of efalizumab in paediatric patients have not been studied.
Maltese: Il-farmakokinetika ta' efalizumab f'pazjienti pediatrika ma ġewx issudjati.
English: Treatment of adult patients with moderate to severe chronic plaque psoriasis who have failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapies including
Maltese: Kura ta' pazjienti adulti bi psorjażi kronika plaque moderata għal severa, li ma kellhomx risposta għal, jew għandhom xi kontraindikazzjoni għal, jew huma intoleranti għal kuri sistemiċi oħra inkluz
English: Store in a refrigerator.
Maltese: Taħżinx fi friża.
English: The most frequent symptomatic adverse drug reactions (ADRs) observed during Raptiva therapy were mild to moderate dose-related acute flu-like symptoms including headache, fever, chills, nausea and myalgia.
Maltese: Ir-reazzjonijiet avversi tal-mediċina illi ġew osservati l-iktar spiss huma ħafif-moderat simptomi bħal ta' l-influenza, li huma akuti u doża-relatata, inkluż uġigħ ta ras, deni, sirdat, nawsea u majalġja.
English: • Check you have the right dose, then remove the syringe from the EasyMIX adapter using a ‘twist and pull' action.
Maltese: • Iċċekja li għandek id-doza tajba u neħħi s-siringa mill-EasyMIX adaptor, billi ddawru u tiġbed.
English: SK-831 06 Bratislava Tel: + 421 2 49 267 111
Maltese: Tel: + 421 2 49 267 111
English: Another pharmacodynamic marker, consistent with the mechanism of action of efalizumab, was the increase in the absolute counts of circulating leukocytes observed during efalizumab treatment.
Maltese: Marker ieħor farmakodinamiku, li huwa konsistenti mal-mod ta' kif jaħdem efalizumab, kien iz-zieda fin-numri assoluti tal-lewkoċiti fiċ-ċirkulazzjoni li ġie osservat waqt il-kura ma' Raptiva.
English: Through population pharmacokinetic analysis, weight was found to affect efalizumab clearance.
Maltese: Minn analażi farmakokinetiċi ta' populazzjoni, instab li l-piż jaffatwa l-eliminazzjoni ta' efalizumab.
English: In clinical trials, mean lymphocyte counts approximately doubled relative to baseline in subjects receiving 1.0 mg/kg/wk of Raptiva.
Maltese: Fi studji kliniċi, in-numru medja tal-limfoċiti sar madwar doppju tal-linea ta' basi, f'dawk is-suġġetti li rrċevew 1.0mg/kg/ġimgħa ta' Raptiva.
English: The product is supplied in packs of 1 vial of powder, 1 pre-filled syringe of solvent, 1 EasyMIX adapter for reconstitution, 1 needle for injection; in packs of 4 vials of powder, 4 pre-filled syringes of solvent, 4 EasyMIX adapters for reconstitution, 4 needles for injection and in packs of 12 vials of powder, 12 pre-filled syringes of solvent, 12 EasyMIX adapters for reconstitution and 12 needles for injection.
Maltese: Il-prodott huwa xxuplit f'pakketti ta' vjala waħda ta' trab, siringa mimlija lesta għall-użu ta' solvent, EasyMIX adaptor għal rikostituzzjoni, labra oħra għall-injezzjoni, pakketti ta' 4 vjali ta' trab, 4 siringi mimlijien lesti għall-użu, 4
English: If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2°C to 8°C, unless reconstitution has taken place in controlled and validated aseptic conditions.
Maltese: Jekk ma jintużax immedjatament, iż-żmien ta' in-use storage u kondizzjonijiet qabel lużu huma r-responsabilita' ta' dak li qed jużah u normalment dan ma jkunx aktar minn 24 sigħat f'temperatura ta' 2°C - 8°C, sakemm ir-rikostituzzjoni ma sarx taħt kondizzjonijiet kontrollati u asettiċi.
English: b p<0.001.
Maltese: Pihatörmä 1 C
English: • Back pain, joints pain, headache, vomiting, weakness, fatigue or rash.
Maltese: • Uġigħ f'darek, uġigħ ta' ras, rimettar, debbulizza, għas jew raxx.
English: There have been no formal drug interaction studies performed with Raptiva.
Maltese: Ma sarux studji formali fuq mediċinali oħra li ma jaqblux ma' Raptiva.
English: b) Vaccinations
Maltese: b) Tilqima
English: Physico-chemical stability of the reconstituted product has been shown for 24 hours at 2°C to 8°C.
Maltese: L-istabilta' fisjo-kimika tal-prodott rikostitut kien dimostrat għal 24 sigħat f'temperatura ta'
English: 1 pre-filled syringe of 1.3 ml solvent.
Maltese: Siringa waħda mimlija lesta ta' 1.3ml ta' solvent.
English: After subcutaneous administration of efalizumab peak plasma concentrations are reached after 12 days.
Maltese: Is-soluzzjoni suppost jkun rikostitut f'mhux aktar minn 5 minuti.
English: For instructions for use see section 6.6.
Maltese: Antikorpi għal efalizumab instabu f'6% biss ta' pazjienti.
English: Do not shake (Shaking will cause foaming of the Raptiva solution).
Maltese: Iddawarx bis-saħħa (dan jista' jikkawza r-ragħwa tas-soluzzjoni ta' Raptiva).
English: The percentage of patients reporting flu-like symptoms was greatest with the first injection and decreased by more than 50% with the second injection.
Maltese: Ilperċentaġġ ta pazjienti li rrapurtaw simptomi bħal ta' l-influenza kien l-akbar ma' l-ewwel injezzjoni, u naqqas iktar minn 50% mat-tieni injezzjoni.