FrancophonIA/ELRC3.0 huggingface dataset:
English: After reconstitution and dilution, 1 ml solution for infusion contains 1.2 mg oritavancin.
Maltese: Wara r-rikostituzzjoni u d-dilwizzjoni, 1 ml tas-soluzzjoni għall-infużjoni jkun fiha 1.2 mg ta' oritavancin
English: • Withdraw 40 mL from each of the three reconstituted vials and add to D5W intravenous bag to bring the bag volume to 1,000 mL.
Maltese: • Iġbed 40 mL minn kull wieħed mit-tliet kunjetti rikostitwiti u żidhom mal-borża tal-infużjoni D5W ġol-vini biex iġġib il-volum tal-borża għal 1,000 mL.
English: Oritavancin has three mechanisms of action: (i) inhibition of the transglycosylation (polymerization) step of cell wall biosynthesis by binding to the stem peptide of peptidoglycan precursors; (ii) inhibition of the transpeptidation (crosslinking) step of cell wall biosynthesis by binding to the peptide bridging segments of the cell wall; and (iii) disruption of bacterial membrane integrity, leading to depolarization, permeabilization, and rapid cell death.
Maltese: (i) l-inibizzjoni tal-pass tat-transglycosylation (polimerizzazzjoni) tal-bijosintesi tal-ħajt taċ-ċelluli permezz tat-twaħħil mal-istem peptide ta' prekursuri ta' peptidoglycan; (ii) l-inibizzjoni tal-pass tat-transpeptidation (crosslinking) tal-bijosintesi tal-ħajt taċ-ċelluli permezz tat-twaħħil mal-peptide bridging segments tal-ħajt taċ-ċelluli; u (iii) linterruzzjoni tal-integrità tal-membrana batterjali, li twassal għal depolarizzazzjoni, permeabilizzazzjoni, u l-mewt mgħaġġla taċ-ċelluli.
English: The safety and efficacy of oritavancin in children and adolescents (<18 years) have not yet been established.
Maltese: Is-sigurtà u l-effikaċja ta' oritavancin fit-tfal u adolexxeni (li għandhom <18-il sena) ma ġewx determinati s'issa.
English: • Muscle pain;
Maltese: • Tħossok stordut;
English: No effect of oritavancin on the in vivo coagulation system was observed in nonclinical and clinical studies.
Maltese: Ma ġie osservat ebda effett ta' oritavancin fuq is-sistema ta' koagulazzjoni in vivo fi studji mhux kliniċi u kliniċi.
English: • Increased blood bilirubin levels ;
Maltese: • Żieda fil-livelli ta' bilirubina fid-demm;
English: Serious hypersensitivity reactions, including anaphylactic reactions and anaphylactic shock have been reported with the use of oritavancin.
Maltese: Reazzjonijiet serji ta' sensittività eċċessiva, inklużi reazzjonijiet anafilattiċi u xokk anafilattiku ġew irrappurtati bl-użu ta' oritavancin.
English: Reconstitution:.
Maltese: Rikostituzzjoni:
English: Bronchospasm, wheezing
Maltese: Bronkospażmu, tħarħir
English: Resistance to oritavancin was observed in vitro in vancomycin-resistant isolates of Staphylococcus aureus.
Maltese: Ġiet osservata reżistenza għal oritavancin in vitro f'iżolati reżistenti għal vancomycin ta'
English: Susceptibility testing break points
Maltese: Break points tal-ittestjar għas-suxxettibbilità
English: • Bone infection caused by bacteria (known as osteomyelitis);
Maltese: • Infezzjoni fl-għadam ikkawżata minn batterji (magħrufa bħala osteomajelite);
English: After dilution, 1 ml of the solution for infusion contains 1.2 mg oritavancin.
Maltese: Wara d-dilwizzjoni, 1 ml tas-soluzzjoni jkun fih 1.2 mg ta' oritavancin.
English: Based on population PK analysis, the population mean total volume of distribution is estimated to be approximately 87.6 L, indicating oritavancin is extensively distributed into the tissues.
Maltese: madwar 87.6 L, u dan jindika li oritavancin jiġi ddistribwit b'mod estensiv ġot-tessut.
English: Concomitant use of warfarin
Maltese: eritema multiforme, fwawar
English: • Feeling dizzy;
Maltese: • Tertir jew rogħda;
English: Due to the possibility of cross-hypersensitivity, there should be careful monitoring of patients with any history of glycopeptide hypersensitivity during and after the infusion.
Maltese: Minħabba possibbiltà ta' sensittività eċċessiva inkroċjata, għandu jkun hemm monitoraġġ b'attenzjoni ta' pazjenti bi kwalunkwe storja medika ta' sensittività eċċessiva għal glycopeptide waqt u wara linfużjoni.
English: Patients should be closely monitored for signs of toxicity or lack of efficacy if they have been given oritavancin while on a potentially affected compound (e.g. patients should be monitored for bleeding, if concomitantly receiving oritavancin and warfarin) (see section 4.4).
Maltese: Il-pazjenti għandhom jiġu mmonitorjati mill-qrib għal sinjali ta' tossiċità jew nuqqas ta' effikaċja jekk ikunu ngħataw oritavancin waqt li jkunu fuq kompost potenzjalment affettwat (eż. il-pazjenti għandhom jiġu mmonitorjati għal ħruġ ta' demm, jekk ikunu qed jirċievu oritavancin u warfarin fl-istess ħin) (ara sezzjoni 4.4).
English: Orbactiv should be prepared under aseptic techniques in a pharmacy.
Maltese: Orbactiv għandu jiġi ppreparat taħt tekniki asettiċi fi spiżerija.
English: The most commonly reported adverse reactions (≥5%) were: nausea, hypersensitivity reactions,
Maltese: L-iktar reazzjonijiet avversi rrappurtati b'mod komuni (≥5%) kienu: dardir, reazzjonijiet ta' sensittività eċċessiva, reazzjonijiet fis-sit tal-infużjoni, u wġigħ ta' ras.
English: Powder for concentrate
Maltese: Ibbażat fuq analiżi
English: Common side effects (may affect up to 1 in 10 patients):
Maltese: Effetti sekondarji komuni (jistgħu jaffettwaw sa 1 minn kull 10 pazjenti):
English: Adverse reactions for oritavancin from the pooled Phase 3 ABSSSI clinical trials with single dose oritavancin are listed by system organ class in the following table.
Maltese: Ir-reazzjonijiet avversi għal oritavancin mill-provi kliniċi miġbura ta' Fażi 3 dwar ABSSSI b'doża waħda ta' oritavancin, huma elenkati skont is-sistema tal-klassifika tal-organi fit-tabella li ġejja.
English: There is no known cross-resistance between oritavancin and non-glycopeptide classes of antibiotics.
Maltese: M'hemm l-ebda reżistenza inkroċjata magħrufa bejn oritavancin u klassijiet ta' antibijotiċi mhux glycopeptide.
English: Studies in neonatal rats and dogs for 30 days showed the same tissue effects as those seen in adult animals including sensitivity to the oritavancin-mediated histamine-like infusion reactions.
Maltese: jum urew l-istess effetti fuq it-tessut bħal dawk li ġew osservati f'annimali adulti li jinkludu sensittività għal reazzjonijiet tal-infużjoni qishom istamina medjati minn oritavancin.
English: Orbactiv 400 mg powder for concentrate for solution for infusion oritavancin
Maltese: Orbactiv 400 mg trab għal konċentrat għal soluzzjoni għall-infużjoni oritavancin
English: In Phase 3 ABSSSI clinical trials, more cases of osteomyelitis were reported in the oritavancin-treated arm than in the vancomycin-treated arm (see section 4.8).
Maltese: Jekk iseħħu reazzjonijiet, it-twaqqif jew it-tnaqqis fil-veloċità tal-infużjoni jista' jirriżulta fit-twaqqif ta' dawn is-sintomi (ara sezzjoni 4.8).
English: Uncommon side effects (may affect up to 1 in 100 patients):
Maltese: Effetti sekondarji mhux komuni (jistgħu jaffettwaw sa 1 minn kull 100 pazjent):
English: Orbactiv is indicated for the treatment of acute bacterial skin and skin structure infections (ABSSSI) in adults (see sections 4.4 and 5.1).
Maltese: Orbactiv hu indikat għall-kura ta' infezzjonijiet akuti batterjali u tal-istruttura tal-ġilda (ABSSSIacute bacterial skin and skin structure infections) fl-adulti.
English: Aseptic procedures should be used for the preparation of Orbactiv.
Maltese: Proċeduri asettiċi għandhom jintużaw għall-preparazzjoni ta' Orbactiv.
English: Oritavancin exhibits reduced in vitro activity against certain Gram-positive organisms of the genera Lactobacillus, Leuconostoc and Pediococcus that are intrinsically resistant to glycopeptides.
Maltese: Lactobacillus, Leuconostoc u Pediococcus li huma intrinsikament reżistenti għal glycopeptides.
English: • Activated Clotting Time (ACT) for up to 24 hours,
Maltese: • il-ħin ta' għaqid attivat (Activated Clotting Time, ACT) għal massimu ta' 24 siegħa
English: A study to assess the drug-drug interaction effect of a single 1,200mg dose of oritavancin on the pharmacokinetics of S-warfarin following a single dose was conducted in 36 healthy subjects.
Maltese: Twettaq studju sabiex jivvaluta l-effett bejn mediċina u oħra ta' doża waħda ta' 1,200 mg ta' oritavancin fuq il-farmakokinetiċi ta' S-warfarin wara doża waħda f'36 individwi b'saħħithom.
English: The pharmacokinetics of oritavancin in patients with severe hepatic impairment (Child-Pugh Class C) has not been evaluated, however based on pharmacokinetic parameters, severe hepatic impairment is not expected to have an impact on oritavancin exposure.
Maltese: parametri farmakokinetiċi, indeboliment sever tal-fwied mhuwiex mistenni li jkollu impatt fuq l esponiment għal oritavancin.
English: Single-use 50 ml Type 1 glass vials with rubber stoppers and aluminium flip off cap. 3 individual vials are packaged in a carton.
Maltese: Kunjetti tal-ħġieġ ta' Tip 1, ta' 50 ml, li jintużaw darba biss, b'tappijiet tal-lastku u għatu tal-aluminju tat-tip flip off. 3 kunjetti individwali jkunu ppakkjati f'kaxxa tal-kartun.
English: EXP
Maltese: mg.
English: No metabolites were observed in plasma or bile from oritavancin treated dogs and rats, respectively.
Maltese: Ma ġew osservati l-ebda metaboliti fil-plażma jew fil-bila minn klieb jew firien ikkurati b'oritavancin, rispettivament.
English: Extramedullary haematopoiesis in the spleen was observed in rats.
Maltese: Ematopoiesi extramedullari fil-milsa ġiet osservata fil-firien.
English: Blood bilirubin increased
Maltese: Wara d-dilwizzjoni
English: • Accumulation of pus underneath the skin.
Maltese: • Akkumulazzjoni ta' materja taħt il-ġilda.
English: The pharmacokinetics of oritavancin in patients with severe renal impairment has not been evaluated.
Maltese: Il-farmakokinetika ta' oritavancin f'pazjenti b'indeboliment sever tal-kliewi ma ġietx evalwata.
English: Elderly (≥ 65 years) No dosage adjustment is required for patients ≥ 65 years of age (see section 5.2).
Maltese: L-ebda aġġustament fid-dożaġġ mhu meħtieġ għal pazjenti li jkollhom ≥ 65 sena (ara sezzjoni 5.2).
English: Caution should be used when administering oritavancin concomitantly with medicinal products with a narrow therapeutic window that are predominantly metabolised by one of the affected CYP450 enzymes(e.g., warfarin), as co-administration may increase (e.g., for CYP2C9 substrates) or decrease (e.g., for CYP2D6 substrates) concentrations of the narrow therapeutic range medicinal product.
Maltese: Dejta farmakodinamika / tossikoloġika fl-annimali uriet li kien hemm eliminazzjoni ta' oritavancin fil ħalib tas-sider (gћad-dettalji ara 5.3). Mhux magħruf jekk oritavancin/metaboliti jiġux eliminati millħalib tas-sider tal-bniedem.
English: The recommended dose for Orbactiv is one single infusion of 1,200 mg administered into a vein over 3 hours.
Maltese: Id-doża rakkomandata għal Orbactiv hi infużjoni waħda ta' 1,200 mg li tingħata ġo vina fuq perjodu ta' 3 sigħat.
English: The mean terminal elimination plasma half-life of oritavancin is 245 hours (14.9% CV) based on population PK analysis of ABSSSI patients receiving a single 1,200 mg dose.
Maltese: Tliet kunjetti ta' Orbactiv 400 mg jeħtieġ li jiġu rikostitwiti u dilwiti biex tipprepara doża waħda ta' 1,200 mg IV li tintuża darba biss.
English: Biochemistry changes associated with kidney function including decreases in urine-specific gravity and pH and slight increases in blood urea nitrogen and sporadic increases in creatinine were present in both rat and dog after treatment of two weeks.
Maltese: Tibdil fil-bijokimika assoċjat mal-funzjoni tal-kliewi li jinkludi tnaqqis fil-gravità speċifika għall awrina u l-pH, u żidiet żgħar fl-urea nitrogen fid-demm u żidiet sporadiċi fil-krejatinina, kienu preżenti kemm fil-firien kif ukoll fil-klieb wara ġimagħtejn ta' kura.
English: Orbactiv 400 mg powder for concentrate for solution for infusion
Maltese: Orbactiv 400 mg trab għal konċentrat għal soluzzjoni għall-infużjoni
English: 1,200 mg administered as a single dose by intravenous infusion over 3 hours.
Maltese: 1,200 mg mogħtija bħala doża waħda permezz ta' infużjoni ġol-vini fuq perjodu ta' 3 sigħat.
English: If not used immediately storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 12 hours at 25°C and 24 hours at 2-8°C for Orbactiv diluted in glucose 5% intravenous infusion bag, unless reconstitution and dilution has taken place in controlled and validated aseptic conditions.
Maltese: 24 siegħa f'temperatura ta' 2-8°C wara d-dilwizzjoni f'borża tal-infużjoni ġol-vini ta' glucose 5%, ħlief jekk ir-rikostituzzjoni u d-dilwizzjoni jkunu saru f'kundizzjonijiet asettiċi kkontrollati u vverifikati.
English: Orbactiv should not to be used in children or adolescents below the age of 18.
Maltese: Orbactiv m'għandux jintuża fit-tfal jew fl-adolexxenti taħt l-età ta' 18-il sena.
English: Al. Jerozolimskie 178 02-486 Warszawa Polska
Maltese: Jerozolimskie 178 02-486 Warszawa Polska
English: Subsequent doses: 1 mg/kg
Maltese: Dożi segwenti: 1 mg/kg
English: Other studies: p-values compared each efalizumab group with placebo using Fisher's exact test within each study.
Maltese: Other studies: p-values compared each efalizumab group with placebo using Fisher's exact test
English: Children and adolescents (< 18 years)
Maltese: Tfal u adolexxenti (< 18 years)
English: Efalizumab is a monoclonal antibody.
Maltese: Efalizumab huwa monoclonal antikorpu.
English: Pharmacotherapeutic group: selective immunosuppressive agents, ATC code: L04AA21
Maltese: Kategorija farmakoterapewtika: selective immunosuppressive agents, Kodiċi ATC code: LO4AA21
English: • Shortness of breath or any persistent respiratory difficulties.
Maltese: • Tuħ fin-nifs u problemi respiratorji persistenti.
English: INFORMATION IN BRAILLE raptiva 100 mg/ml
Maltese: INFORMAZZJONI BIL-BRAILLE raptiva 100 mg/ml
English: Efalizumab is cleared by nonlinear saturable elimination (dose dependent).
Maltese: Efalizumab jiġi eliminat permezz ta' nonlinear saturable elimination (doża-dipendenti).
English: Use in the elderly (≥ 65 years)
Maltese: Użu fl-anżjani (≥ 65 years)
English: Generally reconstitution takes less than 5 minutes.
Maltese: Ġeneralment, rikostituzzjoni jdum inqas minn 5 minuti.
English: Placebo 1.0 mg/kg/wk Treatment Effect [95% CI]
Maltese: Plaċebo 1.0 mg/kg/wk Effett talKura [95% CI]
English: Inflammatory polyradiculoneuropathy*
Maltese: Inflammatory polyradiculo neuropathy*
English: - Keep this leaflet.
Maltese: Pazjienti Kollha
English: Polysorbate 20, histidine, histidine hydrochloride monohydrate and sucrose.
Maltese: Polysorbat 20, histidine, histidine hydrochloride monohydrate u sukrozju.
English: Powder:
Maltese: Psorjażi:
English: Excipients: 2.5 mg polysorbate 20, 3.55 mg histidine, 5.70 mg histidine hydrochloride monohydrate,
Maltese: 2.5 mg polysorbat 20, 3.55 mg histidine, 5.70 mg histidine hydrochloride
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 20 September 2004
Maltese: DATA TA' L-EWWEL AWTORIZZAZZJONI/TIĠDID TA' L-AWTORIZZAZZJONI Data ta' l-ewwel awtorizzazzjoni: 20 Settembru 2004
English: E. Merck AB S-195 87 Stockholm Tel: +46-8-562 445 00
Maltese: S-195 87 Stockholm Tel: +46-8-562 445 00
English: Among 3291 patients in the combined safety database, 39 patients presented an erythrodermic or pustular psoriasis (1.2%).
Maltese: Fost it-3291 pazjienti fid-database ikkombinat tas-sigurta', 39 pazjienti kellhom erythrodermic jew pusutalar psorjażi (1.2%).
English: Aseptic meningitis*, Severe infections*, JC virus infection resulting in progressive multifocal leukoencephalopathy*
Maltese: Meninġite assetika*, infezzjonijiet severi*, Infezzjoni talJC virus riżultanti f'lewkoenkefa lopatija progressiva multifokali*
English: Raptiva is a systemic psoriasis medicine.
Maltese: Raptiva huwa mediċina sistemika għal psorjażi.
English: Merck Farma y Química, S.L.
Maltese: Merck Farma y Química, S.L. María de Molina, 40
English: c) Malignancies and lymphoproliferative disorders
Maltese: c) Malinni u diżordni limfoproliferattivi
English: (See section 4.4).
Maltese: (ara sezzjoni 4.4).
English: SI-1000 Lubliana, Slovenia Tel: +386 1 560 3 800
Maltese: Lubliana, Slovenia Tel: +386 1 560 3 800
English: Over long term treatment, the incidence of serious infection was 1.8 per 100 patient years (see section 4.
Maltese: F'kura għal tul ta żmien, l'inċidenza ta; infezzjoni serja kien ta 1.8/100 patientyears(ara sezzjoni 4.4).
English: Hypersensitivity and allergic reactions
Maltese: Sensittività eċċessiva u reazzjonijiet allerġiċi
English: Tend at steady state is 25 days (range 13-35 days).
Maltese: Tend fi fiss huwa 25 ġurnata (firxa ta' 13-35 ġranet).
English: Efalizumab is a recombinant humanized monoclonal antibody that binds specifically to the CD11a subunit of LFA-1 (lymphocyte function-associated antigen-1), a leukocyte cell surface protein.
Maltese: Efalizumab huwa monoclonal antikorpu umanizzat rikombinat li jorbot speċifikament mas-subunit CD11a ta' LFA-1 (lymphocyte function-associated antigen-1), proteina li tinsab fuq il-wiċċ taċ-ċellula
English: During treatment with Raptiva, cases of exacerbation of psoriasis, including pustular, erythrodermic, and guttate subtypes, have been observed (see section 4.8).
Maltese: Waqt kura ma' Raptiva, ka\ijiet ta' psorajiżi li jsir iktar gravi, inkluż it-tipi pustular, erythrodermic u guttate, ġew osservati (ara sezzjoni 4.8).
English: The use of Raptiva may be associated with an increased risk of Progressive Multifocal Leukoencephalopathy (PML).
Maltese: L-użu ta' Raptiva jista' jiġi assoċjat ma' riskju ta' Lewkoenkefalopatija Progressiva Multifokali (PML).
English: The expected degradation products are small peptides and individual amino acids which are eliminated by glomerular filtration.
Maltese: Il-prodotti li huma mistennin wara d-degradazzjoni huma peptidi żgħar u amino aċidi individuali li jiġu eliminati permess ta' filtrazzjoni glomerulari.
English: All values were between 2.5 fold and 3.5 fold the ULN (Upper Limit of Normal).
Maltese: Il-valuri kollha kienu bejn 2.5 u 3.5-il darba il-fuq minn ULN (Upper Limit of Normal).
English: Antibodies to efalizumab were detected in only 6% of patients evaluated.
Maltese: Anitkorpji għal efalizumab kienu skopruti biss f'6% ta' pazjienti evaluatati.
English: Rua Alfredo da Silva, 3-C P-1300-040 Lisboa Tel: +351-21-361 35 00
Maltese: Rua Alfredo da Silva, 3-C P-1300-040
English: PASI score (a PASI 50 response) relative to baseline after 12 weeks of treatment, the time-course of mean PASI percentage improvement from baseline, improvement in the Dermatology Life Quality Index (DLQI), Psoriasis Symptom Assessment (PSA), the Physician's Global Assessment (PGA) of change, change in the PASI thickness component, and change in the body surface area affected.
Maltese: Punti ta' l-aħħar secondarji kienu l-proporzjoni ta suġġetti li kellhom rata ta Minimal jew Clear fuq static global assessment min l-ispeċjalist, il Overall Lesion Severity (OLS), il-proporzjoni ta' pazjienti bi titjieba ta' ≥ 50% fil- PASI score (PASI 50 risposta) relattata mal-linea ta' basi wara 12-il ġimgħa ta' kura, it-tul tal- kors tal-medja titjieba ta' PASI perċentaġġ mil-linea ta' basi, titjieba fil- Dermatology Life Quality Index (DLQI), Psoriasis Symptom Assessment (PSA), Physician's Global Assessment (PGA) ta' kambju, kambju fil-ħxuna talkomponiment ta' PASI, u bidla fil-partijiet tal-ġisem li huma affetwati.
English: In large placebo-controlled clinical studies approximately 4.5% of patients developed sustained elevation of alkaline phosphatase throughout Raptiva therapy compared to 1% in placebo patients.
Maltese: Fi studji kliniċi kbar ikkontrollati minn plaċebo madwar 4.5% ta pazjienti sviluppaw elevazzjoni sostenuta ta alkaline phosphatase waqt it-tul tal-kura ma' Raptiva, ikkomparat minn 1% fil-pazjienti fuq plaċebo.
English: Elevation of ALT:
Maltese: Puntu ta' l-aħħar Primarja:
English: Efalizumab is an IgG1 kappa immunoglobulin, containing human constant region sequences and murine light- and heavy-chain complementary determining
Maltese: Efalizumab huwa IgG1 kappa immunoglobulina, bi sekwenzi kostanti uman u sekwenzi komplimentari ta' katini ħfif u tqal, murini.
English: 12 pre-filled syringes of 1.3 ml solvent.
Maltese: 12 siringi mimlijien lesti ta' 1.3ml ta' solvent.
English: Raptiva may cause mild to moderate flu-like symptoms including headache, chills, nausea, muscle aches and occasionally fever within 48 hours of an injection of Raptiva.
Maltese: Raptiva jista jikkawża simptomi moderati bħal ta' l-influenza inkluż uġigħ ta' ras, sirdat, nawsea, uġigħ fil-muskoli u xi kultant deni fi 48 sigħat ta' injezzjoni ta' Raptiva.
English: 4 EasyMIX adapters for reconstitution.
Maltese: EasyMIX adaptors għal rikostituzzjoni, u 4 labar għall-injezzjoni.
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 ciclosporin, methotrexate and PUVA (see section 5.1 - Clinical Efficacy).
Maltese: Kura ta' pazjienti adulti bi psorajiżi kronika plaque, li hija moderata jew severa, li fallew li jirrispondu għal, jew għandhom xi kontraindikazzjoni għal, jew huma intolerranti għal kuri sistemiċi oħrajn inkluż ciclosporin, methotrexate u PUVA (ara sezzjoni 5.1 - Effikaċja Klinika).
English: In studies using an initial dose of 0.7 mg/kg followed by 11 weekly doses of 1.0 mg/kg, efalizumab maximally reduced expression of CD11a on circulating T lymphocytes to approximately 15-30% of pre-dose baseline values and saturated CD11a to <5% of baseline available CD11a binding sites.
Maltese: Fi studji, fejn intuża doża iniżjali ta' 0.7mg/kg, issegwit minn 11-il ġimgħa ta' doża kull ġimgħa ta' 1.0%mg/kg, efalizumab naqqas, b'effett massimu, l-espressjoni ta' CD11a fuq T-limfoċiti fiċċirkulazzjoni, għal madwar 15-30% tal-valuri tal-linea basi qabel id-doża u CD11a ssaturat għal <5% tal-linea basi li hemm CD11a siti għar-rabta.
English: 4 pre-filled syringes of 1.3 ml solvent.
Maltese: 4 siringi mimlijien lesti ta' 1.3ml ta' solvent.
English: Very rare
Maltese: Rari ]afna
English: Antibody response to an experimental neo-antigen (∅X174) was reduced during Raptiva therapy, but began to normalize 6 weeks after discontinuation of Raptiva therapy and did not demonstrate tolerance induction.
Maltese: Ir-risposta ta' l-antikorpi għal antiġen ġdida taħt l-esperiment (∅X174) kienet imnaqqsa waqt il-kura ma' Raptiva, iżda sar normali 6 ġimgħat wara li twaqqaf Raptiva u ma wriex tolerance indcution.
English: Raptiva has not been studied in combination with immunosuppressive systemic antipsoriasis medicinal products.
Maltese: Raptiva ma ġiex studjat ma prodotti mediċinali sistemiċi immunosuppressive kontra l-psorajiżi.
English: (n=342) b p-values compared efalizumab with placebo using logistic regression including baseline PASI score, prior treatment for psoriasis and geographical region as covariates.
Maltese: (n=342) b 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
English: The increase included CD4 T-lymphocytes, CD8 T-lymphocytes, B-lymphocytes, and natural killer (NK) cells, although NK cells and CD4 cells increased less relative to other cell types.
Maltese: T-limfoċiti, CD8 Tlimfoċiti, B-limf006ċiti u ċelluli natural killer (NK), anke jekk iċ-ċelluli NK u CD4 zdiedu inqas, meta kkomparat ma' ċelluli ta tipi oħrajn.
English: In this small number of patients no differences were observed in either pharmacodynamic or pharmacokinetic parameters.
Maltese: F'dan in-numru iżgħar ta' pazjienti ma ġewx osservati xi differenżi la fil-parametri farmakodinamiċi jew farmaokokientiċi.
English: In large placebo-controlled clinical studies, the percentage of patients experiencing an adverse event suggestive of hypersensitivity, including urticaria, rash and allergic reactions was slightly higher in the Raptiva group (8%) than in the placebo group (7%).
Maltese: Fi studji kliniċi kbar ikkontrollati minn plaċebo, il-perċentaġġ ta' pazjienti li kellhom esperjenza ta xi effett avvers ta' ipersensitivita' inkluz l-urtikarja, raxx u reazzjonijiet allerġiċi kien xi ftit għola filgrupp ta Raptiva (8%) milli fil-grupp ta plaċebo (7%).