FrancophonIA/ELRC3.0 huggingface dataset:
English: • The active substance is enfuvirtide.
Maltese: ● Is-sustanza attiva hi enfuvirtide.
English: OB (N=334)
Maltese: (N=334)
English: 27 May 2003
Maltese: 27 ta' Mejju 2003
English: 27 May 2008
Maltese: 27 ta' Mejju 2008
English: Fuzeon +Optimised background a
Maltese: Fuzeon + Sfond ottimizzat a
English: 11.0 to 15.5
Maltese: 11.0 sa' 15.5
English: 1 copies/ml
Maltese: kopji/ml
English: gGrade 3= > 3 cm but ≤ 5 cm; Grade 4= > 5 cm.
Maltese: Grad 4= mhux definita. gGrad 3= > 3 cm iżda ≤ 5 cm; Grad 4= > 5 cm.
English: Erythema c c
Maltese: Eritema c c
English: Subgroups
Maltese: Sottogrupp
English: Fuzeon + OB 90 mg bid (N=661)
Maltese: 90 mg bid (N=661)
English: • anorexia
Maltese: • anoreksja
English: The substitutions observed in decreasing frequency were at aa positions 38, 43, 36, 40, 42 and 45.
Maltese: Issostituzzjonijiet osservati bl-akbar frekwenza mniżżla l-ewwel kienu f'pożizzjonijiet aa 38, 43, 36, 40, 42 u 45.
English: Percentages based on safety population Fuzeon+background (N=663) and background (N=334).
Maltese: Perċentwali bbażat fuq popolazzjoni ta' sigurtà Fuzeon+sfond (N=663) u sfond (N=334).
English: System organ class Frequency
Maltese: Klassi tas-sistemi u tal-organi Frekwenza
English: Pain / discomfort b b
Maltese: Uġigħ / skomdu b b
English: It may harm them,
Maltese: Waqfien jew insuffiċjenza viroloġika meqjusa bħala insuffiċjenzi.
English: Roche Registration GmbH Emil-Barell-Strasse 1 79639 Grenzach-Wyhlen Germany
Maltese: Roche Registration GmbH Emil-Barell-Strasse 1 79639 Grenzach-Wyhlen
English: 24.6 to 29.0
Maltese: 24.6 sa' 29.0
English: 33.6 to 38.0
Maltese: 33.6 sa' 38.0
English: It is bound predominantly to albumin and to a lower extent to α-1 acid glycoprotein.
Maltese: Huwa marbut laktar ma' albumin u fi grad anqas ma' α-1 acid glycoprotein.
English: Table 1: Paediatric Dosing Weight (kg)
Maltese: Tabella 1: Dożaġġ Pedjatriku Piż (kg)
English: After reconstitution: Store in a refrigerator (2°C - 8°C).
Maltese: Aħżen fi friġġ (2°C - 8°C).
English: Roche Slovensko, s.r.o.
Maltese: Slovenská republika Roche Slovensko, s.r.o.
English: Fuzeon contains no preservative.
Maltese: Fuzeon ma fihx preservattivi.
English: Step D: Injecting Fuzeon
Maltese: Pass D: Injezzjoni ta' Fuzeon
English: • acne
Maltese: • akne
English: HIV RNA >1 log below Baseline**
Maltese: RNA ta' HIV >1 log taħt Il-Linja Bażi**
English: This may result in a false positive HIV test with the anti-HIV ELISA test.
Maltese: Dan jista' jwassal għal riżultat tat-test għall-HIV pożittiv falz bit-test anti-HIV ELISA.
English: Of these, 185 (98.9%) env genes carried specific substitutions in region of aa 36 - 45 of gp41.
Maltese: Minn dawn, 185 (98.9 %) ġeni ta' env kellhom sostituzzjonijiet speċifiċi ta' aa 36 - 45 ta' gp 41.
English: BL HIV-1 RNA < 5.0 log10
Maltese: BL RNA ta' HIV-1 < 5.0 log10
English: 29.1 to 33.5
Maltese: 29.1 sa' 33.5
English: 38.1 to 42.5
Maltese: 38.1 sa' 42.5
English: The geometric mean changes ranged from 15.2 fold for V38M to 41.6 fold for V38A.
Maltese: 2-il darba għal V38M għal 41.6-il darba għal V38A.
English: Excipient with known effect: sodium.
Maltese: Eċċipjent b'effett magħruf: sodium.
English: 20.1 to 24.5
Maltese: 20.1 sa' 24.5
English: Sinusitis, skin papilloma, influenza, pneumonia, ear infection
Maltese: Sinożite, papilloma tal-ġilda, influwenza, pulmonite, infezzjoni tal-widnejn
English: Frequency categories are defined using the following convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); not known (cannot be estimated from the available data).
Maltese: Kategoriji ta' frekwenza huma definiti bl-użu talkonvenzjoni li ġejja: komuni ħafna (≥1/10); komuni (≥1/100 sa <1/10); mhux komuni (≥1/1,000 sa <1/100); rari (≥1/10,000 sa <1/1,000), rari ħafna (<1/10,000); mhux magħrufa (ma tistax tittieħed stima mid-dejta disponibbli).
English: ANNEX II
Maltese: Tabella 5
English: Withdrawal Rate due to ISRs Event Category
Maltese: Rata ta' Rtirar minħabba ISRs Kategorija tal-Avveniment
English: • decreased sensation
Maltese: • sensazzjoni mnaqqsa
English: Confidence Interval p-value
Maltese: Konfidenz a valur p
English: As per the judgment of the investigator.
Maltese: Skond id-deċiżjoni ta' l-investigatur.
English: Combination studies of enfuvirtide with representative members of the various antiretroviral classes exhibited additive to synergistic antiviral activities and an absence of antagonism.
Maltese: Studji ta' kombinazzjoni ta' enfuvirtide flimkien ma' membri rappreżentattivi taddiversi klassijiet antiretrovirali wrew attivitajiet antivriali addittivi sa sinerġistiċi u nuqqas ta' antagoniżmu.
English: 79639 Grenzach-Wyhlen Germany
Maltese: 79639 Grenzach-Wyhlen
English: 6.1 List of excipients
Maltese: FARMAĊEWTIKU 6.1 Lista ta' eċċipjenti
English: D-79639 Grenzach-Wyhlen Germany
Maltese: D-79639 Grenzach-Wyhlen
English: Myalgia
Maltese: Mijalġja
English: Studies in Antiretroviral Experienced Patients: The clinical activity of Fuzeon (in combination with other antiretroviral agents) on plasma HIV RNA levels and CD4 counts have been investigated in two randomised, multicentre, controlled studies (TORO 1 and TORO 2) of Fuzeon of 48 weeks duration.
Maltese: L-attività klinika ta' Fuzeon (mogħti flimkien ma' aġenti antiretrovirali oħrajn) fuq livelli ta' RNA ta' l-HIV fil-plażma u l-għadd CD4 ġiet investigata f'żewġ studji ta' 48 ġimgħa randomised, multiċentrali u kontrollati (TORO 1 u TORO 2) b'Fuzeon.
English: Log Change from baseline (log10 copies/ml)*
Maltese: Log Bidla mill-linja bażi (log10 kopji/ml)*
English: Each vial contains 108 mg enfuvirtide.
Maltese: INDIVIDWALI 108 mg enfuvirtide
English: In Vitro resistance to enfuvirtide: HIV-1 isolates with reduced susceptibility to enfuvirtide have been selected in vitro which harbour substitutions in amino acids (aa) 36-38 of the gp41 ectodomain.
Maltese: Iżolati ta' HIV-1 b'suxxettibiltà mnaqqsa għal enfuvirtide ntagħżlu in vitro li għandhom sostituzzjonijiet f'aċidi amminiċi (aa) 36-38 ta' gp41 ectodomain.
English: Denominator for non-switch patients: N=112.
Maltese: Denominatur għal pazjenti li ma qalbux: N=112.
English: Laboratory abnormalities
Maltese: Anormalitajiet tal-Laboratorju
English: • inflamed eye (conjunctivitis)
Maltese: • għajn infjammata (konġuntivite)
English: Adverse reactions are listed according to MedDRA system organ class and frequency category.
Maltese: Reazzjonijiet avversi huma elenkati skont il-klassi tas-sistemi u talorgani MedDRA u l-kategorija ta' frekwenza.
English: Signs of autoimmune disorders
Maltese: Sinjali ta' disturbi awtoimmuni
English: OB alone regimen Per 100 patient years n (Total Exposure patient years) ALAT Gr. 3 (>5-10 x ULN) Gr. 4 (>10 x ULN) Haemoglobin Gr. 3 (6.5-7.9 g/dL) Gr. 4 (<6.5 g/dL) Creatinine phosphokinase Gr. 3 (>5-10 x ULN) Gr. 4 (>10 x ULN)
Maltese: Gr. 3 (6.5-7.9 g/dL) Gr. 4 (<6.5 g/dL) Creatinine phosphokinase Gr. 3 (>5-10 x ULN)
English: Pruritus f
Maltese: Ħakk f
English: HIV-1 RNA < 400 copies/ml
Maltese: RNA ta' HIV-1 < 400 kopja/ml
English: Table 6 Proportion of Patients achieving <400 copies/ml and <50 copies/ml at Week 48 by subgroup (pooled TORO 1 and TORO 2, ITT)
Maltese: Tabella 6 Proporzjon ta' pazjenti li laħqu <400 kopja/ml u <50 kopja/ml f'Ġimgħa 48 skond is-sottogrupp (TORO 1 u TORO 2 miġbura flimkien, ITT)
English: ≥ 2 Active ARVs in background1,2
Maltese: ≥2 ARVs fl-isfond
English: aluminium seal with flip-off cap
Maltese: siġill tal-aluminju b'għatu flip-off
English: 60 vials of Fuzeon
Maltese: 60 kunjett ta' Fuzeon
English: Pancreatitis, gastro-oesophageal reflux disease
Maltese: Pankreatite, marda ta' rifluss gastro-esofagali
English: MARKETING AUTHORISATION NUMBER(S) EU/1/03/252/001
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/03/252/001
English: Seal:
Maltese: Tista'
English: Table 3: Summary of individual signs/symptoms characterising local injection site reactions in studies TORO 1 and TORO 2 combined (% of patients) n=663
Maltese: Tabella 3: Sommarju ta' sinjali/sintomi ndividwali li jikkaratterizzaw reazzjonijiet lokali fis-sit tal-injezzjoni fl-istudji TORO 1 u TORO 2 ikkombinati (% ta' pazjenti)
English: Drawing up Fuzeon into the 1 ml syringe
Maltese: Ġbid ta' Fuzeon fis-siringa ta' 1 ml
English: A dose of 2 mg/kg bid (maximum 90 mg bid) provided enfuvirtide plasma concentrations similar to those obtained in adult patients receiving 90 mg bid dosage.
Maltese: Doża ta' 2 mg/kg (massimu ta' 90 mg) tat konċentrazzjonijiet ta' enfuvirtide fil-plażma simili għal dawk f'pazjenti adulti li rċivew dożaġġ ta' 90 mg bid.
English: HIV-1 RNA < 50 copies/ml
Maltese: RNA ta' HIV-1 < 50 kopja/ml
English: The marketing authorisation holder shall submit periodic safety update reports for this product in accordance with the requirements set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and published on the European medicines web-portal
Maltese: Id-detentur tal-awtorizzazzjoni għat-tqegħid fis-suq għandu jippreżenta rapporti perjodiċi aġġornati dwar is-sigurtà għal dan il-prodott f'konformità mar-rekwiżiti mniżżla fil-lista tad-dati ta' referenza tal-Unjoni (lista EURD) prevista skont l-Artikolu 107c(7) tad-Direttiva 2001/83/KE u ppubblikati fuq il-portal elettroniku Ewropew tal-mediċini.
English: In vitro human microsomal studies and in in vivo studies indicate that enfuvirtide is not an inhibitor of CYP450 enzymes.
Maltese: Studji mikrosomali umani in vitro u studji in vivo jindikaw li enfivirtide m'huwiex impeditur ta' lenżimi CYP450.
English: No clinically significant pharmacokinetic interactions are expected between enfuvirtide and concomitantly given medicinal products metabolised by CYP450 enzymes.
Maltese: Interazzjonijiet farmakokinetiċi ta' sinifikanza klinika mhumiex mistennija bejn enfuvirtide u l-għoti flimkien ta' prodotti mediċinali metabolizzati bl-enżimi CYP450.
English: 15.6 to 20.0
Maltese: 15.6 sa' 20.
English: dGrade 3= ≥ 25 mm but < 50 mm average diameter; Grade 4= ≥ 50 mm average diameter.
Maltese: Grad 4 = dijametru medju ta' ≥ 85 mm. dGrad 3= dijametru medju ta' ≥ 25 mm iżda <50 mm; Grad 4= dijametru medju ta' ≥ 50 mm. eGrad 3= ≥ 3 cm;
English: The Manufacturer responsible for batch release is Roche Pharma AG
Maltese: Manifattur responsabbli għall-ħruġ tal-lott Roche Pharma AG
English: Mechanism of Action: Enfuvirtide is a member of the therapeutic class called fusion inhibitors.
Maltese: Enfuvirtide huwa membru tal-klassi terapewtika msejħa inibituri tal-fużjoni.
English: Closure:
Maltese: Eliminazzjoni:
English: BL HIV-1 RNA ≥ 5.0
Maltese: BL RNA ta' HIV-1 ≥ 5.0 log10
English: Anxiety, nightmare, irritability
Maltese: Ansjetà, ħmar il-lejl, irritabilità
English: HIV-1 RNA
Maltese: RNA ta' HIV-1
English: Draw back 1.1 ml of air.
Maltese: Iġbed lura 1.1 ml arja.
English: Total prior ARVs >
Maltese: Total ta' ARVs qabel Total ta' ARVs qabel
English: Fuzeon is indicated in combination with other antiretroviral medicinal products for the treatment of HIV-1 infected patients who have received treatment with and failed on regimens containing at least one medicinal product from each of the following antiretroviral classes: protease inhibitors, nonnucleoside reverse transcriptase inhibitors and nucleoside reverse transcriptase inhibitors, or who have intolerance to previous antiretroviral regimens (see section 5.1).
Maltese: Fuzeon huwa indikat f'kombinazzjoni flimkien ma' prodotti mediċinali antiretrovirali oħrajn għallkura ta' pazjenti infettati bl-HIV-1 li rċievew trattamenti li ma rnexxewx bi programmi ta' kura li fihom għall-anqas prodott mediċinali wieħed minn kull klassi antiretrovirali li ġejja: impedituri talprotease, impedituri ta' non-nucleoside reverse transcriptase u impedituri ta' nucleoside reverse transcriptase, jew li għandhom intolleranza għall-programmi ta' kura antiretrovirali ta' qabel (ara sezzjoni 5.1).
English: Injection volume (90 mg enfuvirtide per ml)
Maltese: Volum ta' l-injezzjoni (90 mg enfuvirtide kull ml)
English: • diarrhoea
Maltese: • dijarea
English: Table 2: Adverse reactions attributed to treatment with Fuzeon in studies TORO 1 and TORO 2 combined
Maltese: Tabella 2: Reazzjonijiet avversi attribwiti lill-kura b'Fuzeon fl-istudji TORO 1 u TORO 2 ikkombinati
English: • Make sure you have 1.1 ml of Water for Injections in the syringe.
Maltese: • Kun żgur li jkollok 1.1 ml Ilma għall-Injezzjonijiet fis-siringa.
English: For instructions on reconstitution before administration, see section 6.6.
Maltese: Għal struzzjonijiet fuq irrikostituzzjoni qabel l-amministrazzjoni, ara sezzjoni 6.6.
English: Fuzeon contains the active substance enfuvirtide and belongs to a group of medicines called ‘antiretrovirals'.
Maltese: Fuzeon fih is-sustanza attiva enfuvirtide u jagħmel parti minn grupp ta' mediċini msejħa ‘antiretrovirali'.
English: This will reduce the risk of bacterial infections.
Maltese: Dan inaqqas ir-riskju ta' infezzjonijiet minn batterja.
English: Paediatric population: The pharmacokinetics of enfuvirtide have been studied in 37 paediatric patients.
Maltese: Il-farmakokinetika ta' enfuvirtide ġiet studjata f'37 pazjent pedjatriku.
English: In four separate studies (N = 9 to 12) the mean steady state trough plasma concentration ranged from 2.6 to 3.4 µg/ml.
Maltese: F'erba' studji separati (N=9 sa' 12) il-medja ta' konċentrazzjoni l-aktar baxxa fi stat fiss fil-plażma varjat minn 2.6 sa' 3.4 μg/ml.
English: Few patients included in the phase III trials were co-infected with hepatitis B/C.
Maltese: III kien hemm ftit pazjenti li kienu ko-infettati bl-epatite B/C.
English: Events included rash, fever, nausea and vomiting, chills, rigors, low blood pressure and elevated serum liver transaminases in various combinations, and possibly primary immune complex reaction, respiratory distress and glomerulonephritis.
Maltese: Avvenimenti nkludew raxx, deni, tqalligħ u rimettar, tertir, rogħda ta' bard, pressjoni taddemm baxxa u transaminases tal-fwied għoljin fis-serum f'diversi kombinazzjonijiet, u possibilment reazzjoni primarja ta' kumpless immuni, distress respiratorju u glomerulonefrite.
English: The pharmacokinetic properties of enfuvirtide have been evaluated in HIV-1-infected adult and paediatric patients.
Maltese: It-tagħrif farmakokinetiku ta' enfuvirtide ġie evalwat f'pazjenti adulti u pedjatriċi infettati bl-HIV-1.
English: Patient demographics include a median baseline HIV-1 RNA of 5.2 log10 copies/ml and 5.1 log10 copies/ml and median baseline CD4 cell count of 88 cells/mm3 and 97 cells/mm3 for Fuzeon + OB and OB, respectively.
Maltese: Id-demografika tal-pazjenti jinkludu linja bażi medjana ta' RNA ta' HIV-1 ta' 5.2 log10 kopji/ml u 5.1 log10 kopji/ml u l-linja bażi medjana tal-għadd ta' ċelluli CD4 ta' 88 ċellula/mm u 97 ċellula/mm għal Fuzeon + OB u OB, rispettivament.
English: Step B: Mixing Fuzeon
Maltese: Pass B: Biex Tħallat Fuzeon
English: Infections at the injection site (including abscess and cellulitis) occurred in 1.5% of patients.
Maltese: Infezzjonijiet fis-sit tal-injezzjoni (inkluż aċċess u ċellulite) seħħew f'1.5 % tal-pazjenti.
English: Gastrointestinal disorders Common
Maltese: Disturbi gastro-intestinali
English: CD4+ cell count Change from baseline (cells/mm3)#
Maltese: Għadd ta' ċelluli CD4+ Bidla mill-linja bażi (celluli/mm
English: Mean (± SD) Cmax was 4.59 ± 1.5 µg/ml, AUC was 55.8 ± 12.1 µg*hr/ml The subcutaneous absorption of enfuvirtide is proportional to the administered dose over the 45 to 180 mg dose range.
Maltese: Cmax medja (± SD) kienet ta' 4.59 ± 1.5 μg/ml, AUC kienet ta' 55.8 ± 12.1 μg*hr/ml.
English: Elderly: The pharmacokinetics of enfuvirtide have not been formally studied in elderly patients over 65 years of age.
Maltese: Il-farmakokinetika ta' enfuvirtide ma ġietx studjati formalment f'pazjenti anzjani b'età 'l fuq minn 65 sena.
English: This metabolite is detected in human plasma following administration of enfuvirtide, with an AUC ranging from 2.4 to 15% of the enfuvirtide AUC.
Maltese: Dan il- metabolita jista' jinstab fil-plażma umana wara l-għoti ta' enfuvirtid, b'AUC li tvarja minn 2.4 sa' 15% ta' l-AUC ta' enfuvirtide.
English: Other medicines and Fuzeon
Maltese: Mediċini oħra u Fuzeon
English: Signs of previous infections
Maltese: Sinjali ta' infezzjonijiet preċedenti
English: Osteonecrosis:
Maltese: Indeboliment epatiku:
English: 180 alcohol swabs.
Maltese: 180 mselħa bl-alkoħol
English: log10
Maltese: Grad 3
English: • The recommended dose is 90 mg twice a day for adults and adolescents (16 years and older).
Maltese: ● Id-doża rakkomandata hija ta' 90 mg darbtejn kuljum għall-adulti u l-adolexxenti (16-il sena jew akbar).
English: Psychiatric disorders Common
Maltese: Disturbi psikjatriċi Komuni
English: Distribution: The steady state volume of distribution with intravenous administration of a 90 mg dose of enfuvirtide was 5.5 ± 1.1 l. Enfuvirtide is 92% bound to plasma proteins in HIV infected plasma over a plasma concentration range of 2 to 10 µg/ml.
Maltese: Enfuvirtide huwa 92% marbut ma' proteini tal-plażma fi plażma infettata bl-HIV fuq medda ta' konċentrazzjonijiet fil-plażma bejn 2 sa' 10 μg/ml.
English: Respiratory, thoracic and mediastinal disorders Common
Maltese: Disturbi respiratorji, toraċiċi u medjastinali Komuni
English: Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Maltese: Sensittività eċċessiva għas-sustanza attiva jew għal kwalunkwe wieћed mill-eċċipjenti elenkati fissezzjoni 6.1.
English: Each vial with powder also contains sodium carbonate (anhydrous), mannitol, sodium hydroxide and hydrochloric acid.
Maltese: Kull kunjett fih ukoll sodium bicarbonate (anhydrous), mannitol, sodium hydroxide u hydrochloric acid.
English: In 25 paediatric patients ranging in age from 5 to 16 years and receiving the 2 mg/kg bid dose into the upper arm, anterior thigh or abdomen, the mean steady-state AUC was 54.3 ± 23.5 µg*h/ml, Cmax was 6.14 ± 2.48 µg/ml, and Ctrough was 2.93 ± 1.55 µg/ml.
Maltese: F'25 pazjent pedjatriku ta' etajiet bejn il-5 u s-16-il sena li rċevew doża ta' 2 mg/kg bid fin-naħa ta' fuq tad-driegħ, fin-naħa ta' quddiem tal-koxxa jew fladdome, l-AUC fi istat fiss medju kienet ta' 54.3 ± 23.5 μg*h/ml, is-Cmax kienet ta' 6.14 ± 2.48 μg/ml, u s-Ctrough kienet ta' 2.93 ± 1.55 μg/ml.
English: Influence of concomitant medicinal products on enfuvirtide metabolism: In separate pharmacokinetic interaction studies, co-administration of ritonavir (potent CYP3A4 inhibitor) or saquinavir in combination with a booster dose of ritonavir or rifampicin (potent CYP34A inducer) did not result in clinically significant changes of the pharmacokinetics of enfuvirtide.
Maltese: Fi studji separati ta' interazzjonijiet farmakokinetiċi, l-għoti ta' ritonavir (impeditur qawwi ta' CYP3A4) jew ta' saquinavir flimkien ma' doża booster ta' ritonavir jew rifampicin (induttur qawwi ta' CYP34A) ma wassalx għal tibdil ta' sinifikanza klinika fil-farmakokinetika ta' enfuvirtide.
English: ● redness
Maltese: • ekżema
English: Metabolism and nutrition disorders Common
Maltese: Disturbi fil-metaboliżmu u n-nutrizzjoni
English: For storage conditions after reconstitution of the medicinal product, see section 6.3.
Maltese: Għall-kondizzjonijiet ta' ħażna wara rrikostituzzjoni tal-prodott mediċinali, ara sezzjoni 6.3.
English: Marketing Authorisation Holder Roche Registration GmbH Emil-Barell-Strasse 1
Maltese: Detentur tal-Awtorizzazzjoni għat-tqegħid fis-Suq Roche Registration GmbH
English: Gender and Weight: Analysis of plasma concentration data from patients in clinical trials indicated that the clearance of enfuvirtide is 20% lower in females than males irrespective of weight and is increased with increased body weight irrespective of gender (20% higher in a 100 kg and 20% lower in a 40 kg body weight patient relative to a 70 kg reference patient).
Maltese: Sess u Piż: L-analiżi ta' tagħrif dwar il-konċentrazzjoni fil-plażma minn pazjenti fi provi kliniċi indikat li t-tneħħija ta' enfuvirtide hija 20% inqas fin-nisa milli fl-irġiel irrispettivament mill-piż, u tiżdied mal-piż irrispettivament mis-sess ta' l-individwu (20% ogħla f'pazjent li jiżen 100 kg u 20% anqas f'pazjent li jiżen 40 kg meta mqabbla ma' pazjent li jiżen 70 kg).
English: Fuzeon contains sodium Fuzeon contains less than 1 mmol sodium (23 mg) per dose, i.e. it is essentially ‘sodium-free'.
Maltese: Fuzeon fih anqas minn 1 mmol ta' sodium (23 mg) f'kull doża, jiġifieri huwa essenzjalment ‘ħieles mis-sodium'.
English: Detailed information on this medicine is available on the European Medicines Agency web site: 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: Influence of enfuvirtide on metabolism of concomitant medicinal products: In an in-vivo human metabolism study enfuvirtide, at the recommended dose of 90 mg twice daily, did not inhibit the metabolism of substrates by CYP3A4 (dapsone), CYP2D6 (debrisoquine), CYP1A2 (caffeine), CYP2C19 (mephenytoin), and CYP2E1 (chlorzoxazone).
Maltese: (dapsone), CYP2D6 (debrisoquine), CYP1A2 (kaffeina), CYP2C19 (mephenytoin), u CYP2E1 (chlorzoxazone).
English: • muscle pain
Maltese: • uġigħ fil-muskoli
English: Table 4: Exposure adjusted Grade 3 & 4 laboratory abnormalities among patients on Fuzeon+OB and OB alone regimens, reported at more than 2 patients with event per 100 patient years Laboratory Parameters Grading
Maltese: Tabella 4: Anormalitajiet tal-laboratorju ta' Grad 3 & 4 b'espożizzjoni aġġustata fost pazjenti fuq programm ta' kura b'Fuzeon+OB u OB waħdu, rrapurtati ghal aktar minn 2 pazjenti b'effett kull 100 sena ta' pazjent.
English: 4% N/A
Maltese: 19.4%d
English: • swollen glands (lymph nodes)
Maltese: • glandoli minfuħin (glandoli tal-limfa)
English: 3 ml vial, colourless glass type 1
Maltese: kunjett ta' 3 ml, ħġieġ bla kulur tat-tip 1
English: Contents of the pack and other information Step-by-step guide to injecting Fuzeon
Maltese: Kontenut tal-pakkett u informazzjoni oħra X'fih Fuzeon
English: 60 3 ml syringes
Maltese: 60 siringa tat-3 ml
English: In in vitro human microsomal and hepatocyte studies, hydrolysis of the amide group of the C-terminus amino acid, phenylalanine results in a deamidated metabolite and the formation of this metabolite is not NADPH dependent.
Maltese: Fi studji b'epatoċiti u mikrosomi umani in vitro, l-idrolisi tal-grupp amide ta' l-aċidu aminu fit-terminu C, phenylalanine twassal għal metabolita deamidat u l-formazzjoni ta' dan ilmetabolta m'huwiex dipendenti minn NADPH.
English: lyophilisate stopper, rubber (latex free)
Maltese: Għatu tapp tal-gomma (mingħajr latex)
English: 995 patients comprised the intent-to-treat population.
Maltese: Ilpopolazzjoni b'intenzjoni li tiġi kkurata kienet ta' 995 pazjent.
English: • pneumonia
Maltese: • pnewmonja
English: Detailed information on this medicinal product is available on the web site of the European Medicines Agency: http://www.ema.europa.eu/
Maltese: Informazzjoni dettaljata dwar dan il-prodott mediċinali tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea għall-Mediċini: http://www.ema.europa.eu/.
English: Step C: Preparing for the injection
Maltese: Pass Ċ: Preparzzjoni għall-injezzjoni
English: Fuzeon + OB therapy was associated with a higher proportion of patients reaching <400 copies/ml (or <50 copies/ml) across all subgroups based on baseline CD4, baseline HIV-1 RNA, number of prior antiretrovirals (ARVs) or number of active ARVs in the OB regimen.
Maltese: Terapija ta' Fuzeon + OB kienet assoċjata ma' proporzjon ogħla ta' pazjenti li laħħqu <400 kopja/ml (jew 50 kopja/ml) fis-sotto gruppi kollha bbażat fuq CD4 fil-linja bażi, RNA ta' HIV-1 fil-linja bażi, n-numru ta' antiretrovirali ta' qabel (ARVs) jew in-numru ta' ARVs attivi fil-programm ta' kura OB. Iżda, persuni b'linja bażi ta' CD4 > 100 ċellula/mm
English: Fuzeon 90 mg/ml powder and solvent for solution for injection Enfuvirtide
Maltese: Fuzeon 90 mg/ml trab u solvent għal soluzzjoni għall-injezzjoni Enfuvirtide
English: PHARMACEUTICAL FORM AND CONTENTS Solvent for parenteral use
Maltese: U KONTENUT Solvent għall-użu parenterali