FrancophonIA/ELRC3.0 huggingface dataset:
English: A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE Name and address of the manufacturer responsible for batch release Roche Pharma AG, Emil-Barrell-Str. 1, D-79639 Grenzach-Wyhlen, Germany
Maltese: GĦALL-ĦRUĠ TAL-LOTT Isem u indirizz tal-manifattur responsabbli għall-ħruġ tal-lott Roche Pharma AG, Emil-Barrell-Str.
English: 247 (37.4%) 57 (17.1%) Odds Ratio HIV RNA <400 copies/ml** 201 (30.4%) 40 (12.0%) Odds Ratio HIV RNA <50 copies/ml**
Maltese: 247 (37.4%) 57 (17.1%) Odds Ratio
English: Dry skin, eczema seborrhoeic, erythema, acne
Maltese: IL-KONTENUT SKONT IL-PIŻ, IL-VOLUM, JEW PARTI
English: • flu or ‘flu-like' symptoms
Maltese: • sintomi tal-influwenza jew li ‘jixbħu lill-influwenza'
English: Clinical Pharmacodynamic data
Maltese: Tagħrif Farmakodinamiku Kliniku
English: 1 Active ARV in background1,2
Maltese: ARV 1 fl-isfond
English: • Keep this leaflet.
Maltese: • se tisimgħu ifaqqa'.
English: To reduce the risk of infection, it is important that you follow the instructions provided in Section 7.
Maltese: Biex tnaqqis ir-riskju ta' infezzjoni huwa importanti li ssegwi l-istruzzjonijiet ipprovduti f'Sezzjoni 7.
English: Patients with chronic hepatitis B and C and treated with antiretroviral therapy are at an increased risk for severe and potentially fatal hepatic adverse events.
Maltese: Pazjenti li għandhom epatite B u C kronika li ġew ikkurati b'terapija antiretrovirali għandhom riskju ikbar ta' effetti avversi epatiċi serji u li jistgħu jkunu fatali.
English: Bone disease (osteonecrosis)
Maltese: Mard fl-għadam (osteonekrosi)
English: In these the addition of Fuzeon did not increase the incidence of hepatic events.
Maltese: F'dawn ilkażijiet, iż-żieda ta' Fuzeon ma żidietx l-inċidenza ta' avvenimenti epatiċi.
English: 1 ml of reconstituted solution contains 90 mg of enfuvirtide.
Maltese: 1 ml ta' soluzzjoni rikostitwita fih 90 mg enfuvirtide.
English: Injection site reactions (ISRs) were the most frequently reported adverse reaction and occurred in 98% of the patients (Table 3).
Maltese: Reazzjonijiet fis-sit tal-injezzjoni (ISRs - injection site reactions) kienu l-aktar reazzjonijiet avversi rrappurtati b'mod frekwenti u seħħew f'98% tal-pazjenti (Tabella 3).
English: ● swelling
Maltese: Siġill:
English: 60 1 ml syringes
Maltese: 60 siringa tal-1 ml
English: Pack sizes
Maltese: TA' EĊĊIPJENTI
English: The frequency of this is unknown (see section 4.4).
Maltese: Il-frekwenza ta' din mhix magħrufa (ara sezzjoni 4.4).
English: 60 vials powder for solution for injection 60 vials solvent
Maltese: 60 kunjett bi trab għal soluzzjoni għall-injezzjoni 60 kunjett bis-solvent
English: Contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially ‘sodium-free'.
Maltese: Fih inqas minn 1 mmol ta' sodium (23 mg) f'kull doża, jiġifieri huwa essenzjalment ‘mingħajr sodium'.
English: 2 ml vial, colourless glass type 1
Maltese: kunjett ta' 2ml, ħġieġ bla kulur tat-tip 1
English: Nervous system disorders Very common Common
Maltese: Disturbi fis-sistema nervuża
English: Your syringes
Maltese: DATA TA' SKADENZA
English: Contained in this box are 60 vials of 2 ml water for injections
Maltese: Ġo din il-kaxxa hemm 60 kunjett b'2 ml ilma għall-injezzjonijiet
English: Solvent 4 years
Maltese: 4 snin
English: Where to Inject
Maltese: Infezzjonijiet u infestazzjonijiet
English: 180 alcohol swabs
Maltese: 180 msielaħ bl-alkoħol
English: Table 5 Outcomes of Randomised Treatment at Week 48 (Pooled Studies TORO 1 and TORO 2, ITT) Outcomes
Maltese: Riżultati ta' Kura Randomizzat f'Ġimgħa 48 (Studji Miġbura ta' TORO 1 u TORO 2 ITT)
English: Cross-resistance: Due to its novel viral target enfuvirtide is equally active in vitro against both wildtype laboratory and clinical isolates and those with resistance to 1, 2 or 3 other classes of antiretrovirals (nucleoside reverse transcriptase inhibitors, non-nucleoside reverse transcriptase inhibitors and protease inhibitors).
Maltese: Minħabba l-mira virali ġdida tiegħu, enfuvirtide għandu l-istess livell ta' attività in vitro kemm kontra iżolati kliniċi, kontra dawk tal-laboratorju tat-tip salvaġġ, kif ukoll kontra dawk b'reżistenza għal 1, 2, jew 3 klassijiet oħrajn ta' antiretrovirali (impedituri nucleoside reverse transcriptase, impedituri non-nucleoside reverse transcriptase u impedituri protease).
English: While effective viral suppression with antiretroviral therapy has been proven to substantially reduce the risk of sexual transmission, a residual risk cannot be excluded.
Maltese: Filwaqt li soppressjoni virali effettiva b'terapija antiretrovirali ġiet ippruvata li tnaqqas r-riskju ta' trasmissjoni sesswali b'mod sostanzjali, riskju residwu ma jistax jiġi eskluż.
English: Roche s. r. o. Tel: +420 - 2 20382111
Maltese: Tel: +420 - 2 20382111
English: Pharmacotherapeutic group: Other antivirals, ATC code: J05AX07
Maltese: Antivirali oħrajn, Kodiċi ATC:
English: • feeling dizzy
Maltese: • ġilda xotta
English: Fuzeon must only be reconstituted with 1.1 ml of Water for Injections.
Maltese: Fuzeon għandu jiġi rikostitwit b'1.1 ml Ilma għall-Injezzjonijiet biss.
English: The proportion of patients achieving viral load of <400 copies/ml at week 48 was 30.4% among patients on the Fuzeon + OB regimen compared to 12% among patients receiving OB regimen only.
Maltese: Il-proporzjon ta' pazjenti li laħqu viral load ta' < 400 kopji/ml f'ġimgħa 48 kienu 30.4 % fost ilpazjenti fuq programm ta' kura b'Fuzeon + OB meta mqabbel ma' 12 % fost pazjenti fuq programm ta' kura b'OB waħdu.
English: When using a higher threshold for eosinophilia (>1.4 x 109/l), the patient exposure adjusted rate of eosinophilia is equal in both groups (1.8 patients with event per 100 patientyears).
Maltese: Meta jintuża limitu ogħla għal esinofilja (>1.4 x 109/l), ir-rata aġġustata ta' l-espożizzjoni tal-pazjent ta' esinofilja huwa ugwali fiż-żewġ gruppi (1.8 pazjent b'episodju għal kull 100 sena ta' pazjent) .
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each vial contains 108 mg enfuvirtide.
Maltese: Kull kunjett fih 108 mg enfuvirtide.
English: Therapy with enfuvirtide should not be restarted following systemic signs and symptoms consistent with a hypersensitivity reaction considered related to enfuvirtide.
Maltese: It-terapjia b'enfuvirtide m'għandhiex terġa' tinbeda wara sinjali u sintomi sistematiċi li jindikaw reazzjoni ta' sensittività eċċessiva meqjusa li għandhom x'jaqsmu ma' enfuvirtide.
English: In a renal impairment study AUC of enfuvirtide was increased on average by 43-62% in patients with severe or end stage renal disease compared to patients with normal renal function.
Maltese: Fi studju dwar indeboliment renali, l-AUC ta' enfuvirtide żdiedet b'medja ta' 43-62% f'pazjenti b'indeboliment renali sever jew b'marda renali ta' l-aħħar stadju, meta mqabbel ma' pazjenti b'funzjoni renali normali.
English: 4.8 Undesirable effects a. Summary of the safety profile
Maltese: .8 Effetti mhux mixtieqa a.
English: Relevant examples are cytomegalovirus retinitis, generalised and/or focal mycobacterial infections, and Pneumocystis carinii pneumonia.
Maltese: Eżempji rilevanti huma retinite kkawżata minn cytomegalovirus, infezzjonijiet ġeneralizzati u/jew lokalizzati b'mycobacterium, u pnewmonja kkawżata minn Pneumocystis carinii.
English: In some patients with advanced HIV infection (AIDS) and a history of opportunistic infections, signs and symptoms of inflammation from previous infections may occur soon after anti-HIV treatment is started.
Maltese: F'xi pazjenti b'infezzjoni ta' l-HIV avvanzata (AIDS) u b'passat ta' infezzjonijiet opportunistiċi, jistgħu jseħħu sinjali u sintomi ta' infjammazjoni minn infezzjonijiet ta' qabel ftit wara li tinbeda lkura anti-HIV.
English: Absorption: The absolute bioavailability after subcutaneous administration of enfuvirtide 90 mg in the abdomen was 84.3 ± 15.5%.
Maltese: Il-biodisponibiltà assoluta wara għoti minn taħt il-ġilda ta' enfuvirtide 90 mg fl-addome kienet ta' 84.
English: Powder Vial:
Maltese: Popolazzjoni pedjatrika:
English: In HIV patients, enfuvirtide levels in the cerebrospinal fluid have been reported to be negligible.
Maltese: F'pazjenti bl-HIV, livelli ta' enfuvirtide filfluwidu ċerebrospinali kien irrappurtat bħala negliġibli.
English: * Based on results from pooled data of TORO 1 and TORO 2 on ITT population, week 48 viral load for subjects who were lost to follow-up, discontinued therapy, or had virological failure replaced by their last observation (LOCF).
Maltese: * Bbażat fuq riżultati minn tagħrif kombinat ta' TORO 1 u TORO 2 fuq popolazzjoni ITT, il-viral load f'ġimgħa 48 għal persuni li waqfu wara l-vista ta'wara, waqqfu t-terapija, jew kellhom insuffiċjenza viroloġika sostitwita bl-aħħar osservazzjoni tagħhom (LOCF).
English: Nephrolithiasis, haematuria
Maltese: TWISSIJA(IET) SPEĊJALI
English: Date of latest renewal:
Maltese: Data tal-aħħar tiġdid:
English: ** M-H test: Discontinuations or virological failure considered as failures.
Maltese: ** M-H test:
English: Each solvent vial contains 2 ml Water for Injections.
Maltese: Kull kunjett bis-solvent fih 2 ml Ilma għall-Injezzjonijiet.
English: • feeling anxious or irritated
Maltese: • tħossok ansjuż jew irritat
English: Lymphadenopathy
Maltese: Il-Ġermanja
English: Safety data mainly refer to 48-week data from studies TORO 1 and TORO 2 combined (see section 5.1).
Maltese: TORO 1 u TORO 2 flimkien (ara sezzjoni 5.1).
English: • shaking (tremor)
Maltese: (mg/doża)
English: Immune Reactivation Syndrome: In HIV-infected patients with severe immune deficiency at the time of institution of combination antiretroviral therapy (CART), an inflammatory reaction to asymptomatic or residual opportunistic pathogens may arise and cause serious clinical conditions, or aggravation of symptoms.
Maltese: Sindromu tar-Riattivazzjoni Immuni: F'pazjenti nfetti b'HIV b'defiċjenza immuni severa fil-ħin li tinbeda t-terapija antiretrovirali kombinata (CART), tista' sseħħ reazzjoni infjammatorja għallpatoġeni mingħajr sintomi jew patoġeni residwali opportunistiċi li tista' tikkawża kundizzjonijiet kliniċi serji, jew aggravar tas-sintomi.
English: • blood in the urine
Maltese: • demm fl-urina
English: Appetite decreased, anorexia, hypertriglyceridaemia, blood triglycerides increased, diabetes mellitus
Maltese: Tnaqqis fl-aptit, anoressija, ipertrigliċeridemija, żieda ta' trigliċeridi fid-demm, dijabete mellitus
English: Fuzeon should be used with caution in these populations (see sections 4.2 and 5.2).
Maltese: Fuzeon għandu jintuża b'attenzjoni f'dawn il-gruppi ta' ndividwi (ara sezzjonijiet 4.2 u 5.2).
English: To make sure that the needle is firmly on the syringe:
Maltese: Biex tassigura li l-labra hija mwaħħla sew fuq is-siringa:
English: • nasal congestion
Maltese: • sinusis infjammati
English: • eczema
Maltese: • inkubi
English: Antiviral activity in vitro: The susceptibility to enfuvirtide of 612 HIV recombinants containing the env genes from HIV RNA samples taken at baseline from patients in Phase III studies gave a geometric mean EC 50 of 0.259 µg/ml (geometric mean + 2SD = 1.96 µg/ml) in a recombinant phenotype HIV entry assay.
Maltese: III taw medja ġeometrika ta' EC50 ta' 0.259 μg/ml (medja ġeometrika + 2SD = 1.96 μg/ml) f'analiżi tad-dħul ta' HIV b'fenotip rikombinanti.
English: After reconstitution with the solvent provided 1 ml of reconstituted solution contains 90 mg enfuvirtide.
Maltese: Wara r-rikostituzzjoni massolvent ipprovdut, 1ml tas-soluzzjoni rikostitwita fiha 90 mg enfuvirtide.
English: Fuzeon is used for the treatment of Human Immune deficiency Virus (HIV) - in combination with other antiretroviral medicines in patients infected with HIV.
Maltese: Virus) - flimkien ma' mediċini antiretrovirali oħra f'pazjenti infettati bl-HIV.
English: BATCH NUMBER Batch
Maltese: Fuzeon + OB
English: • inflamed pancreas
Maltese: • infjammazzjoni tal-frixa
English: In Vivo resistance to enfuvirtide: In phase III clinical studies HIV recombinants containing the env genes from HIV RNA samples taken up to week 24 from 187 patients showed > 4 fold reduced susceptibility to enfuvirtide compared with the corresponding pre-treatment samples.
Maltese: III rikombinanti ta' HIV li fihom il-ġeni ta' env minn kampjuni ta' RNA ta' HIV meħuda sa ġimgħa 24 minn 187 pazjent urew tnaqqis ta' > 4 darbiet fis-suxxettibiltà għal enfuvirtide meta mqabbla mal-kampjuni korrispondenti ta' qabel il-kura.
English: In a rat model on the resistance to influenza infection, an impairment of IFN-γ production was observed.
Maltese: F'mudell fil-far dwar ir-reżistenza għall-infezzjoni ta' l-influwenza, kienet osservata tnaqqis fil-produzzjoni ta' IFN-γ.
English: Musculoskeletal, connective tissue and bone disorders
Maltese: Disturbi muskolu-skeletriċi u tat-tessuti konnettivi u tal-għadam Komuni
English: Fuzeon+OB regimen Per 100 patient years
Maltese: Programm ta' kura b' Fuzeon+OB Kull 100 sena ta'
English: Discontinued due to adverse reactions/intercurrent illness/labs†
Maltese: Twaqqfu minħabba reazzjonijiet avversi/mard fl-istess waqt/lab †
English: CD4 >100 cells/mm3, baseline HIV-1 RNA <5.0 log10 copies/ml, ≤ 10 prior ARVs, and/or other active
Maltese: 3, linja bażi ta' RNA ta' HIV-1 <5.0 log10 kopji/ml, u/jew ARVs attivi oħra, fil-programm ta' kura ta' OB tagħhom kienu aktar probabbli li jiksbu RNA ta' HIV-1 ta' <400 kopja/ml (jew < 50 kopja/ml) fuq kwalunkwe kura (ara Tabella 6).
English: Elimination: Clearance of enfuvirtide after intravenous administration 90 mg was 1.4 ± 0.28 l/h and the elimination half-life was 3.2 ± 0.42 h. Following a 90 mg subcutaneous dose of enfuvirtide the half-life of enfuvirtide is 3.8 ± 0.6 h. Mass balance studies to determine elimination pathway(s) of enfuvirtide have not been performed in humans.
Maltese: It-tneħħija ta' enfuvirtide wara għoti ta' 90 mg minn ġol-vini kienet ta' 1.4 ± 0.28 l/h u l-half-life kienet ta' 3.2 ± 0.
English: 60 vials of Water for Injections that is used to reconstitute the Fuzeon powder 60 3 ml syringes
Maltese: 60 kunjett ta' Ilma għall-Injezzjonijiet li jintuża għar-rikostituzzjoni tat-trab Fuzeon 60 siringa tat-3 ml
English: Race: Analysis of plasma concentration data from patients in clinical trials indicated that the clearance of enfuvirtide was not different in Afro-Americans compared to Caucasians.
Maltese: L-analiżi ta' tagħrif dwar il-konċentrazzjoni fil-plażma minn pazjenti fi provi kliniċi ndikat li ttneħħija ta' enfuvirtide ma kienetx differenti f'Afro-Amerikani meta mqabbla mal-Kawkasi.
English: Patients should be informed that Fuzeon is not a cure for HIV-1 infection.
Maltese: Il-pazjenti għandhom jiġu nformati li Fuzeon mhux kura għall-infezzjoni ta' HIV-1.
English: Each ml of reconstituted solution contains 90 mg enfuvirtide.
Maltese: Kull ml ta' soluzzjoni rikostitwita fiha 90 mg enfuvirtide.
English: Although the etiology is considered to be multifactorial (including corticosteroid use, alcohol consumption, severe immunosuppression, higher body mass index), cases of osteonecrosis have been reported particularly in patients with advanced HIV-disease and/or long-term exposure to CART.
Maltese: Għalkemm l-etjoloġija hija kkunsidrata li ġejja minn ħafna fatturi (inkluż l-użu ta' kortikosterojdi, konsum ta' alkoħol, immunosoppressjoni severa, indiċi tal-massa tal-ġisem għola), każijiet ta' osteonekrożi ġew irrappurtati partikolarment f'pazjenti b'marda ta' l-HIV avvanzata u/jew esponiment fit-tul għal terapija antiretrovirali kombinata (CART).
English: Batch
Maltese: Kft.
English: Through week 48, eosinophilia [greater than the Upper Limit of Normal of > 0.7 x 109/l] occurred at a higher rate amongst patients in the Fuzeon containing group (12.4 patients with event per 100 patient-years) compared with OB alone regimen (5.6 patients with event per 100 patient-years).
Maltese: Matul l-48 ġimgħa, esinofilja [aktar mill-Limitu ta' Fuq tan-Normal ta' > 0.7 x 109/1] seħħet b'rata ogħla f'pazjenti fil-grupp b'Fuzeon (12.4 pazjent b'effett għal kull 100 sena ta' pazjent) meta mqabbla ma' programm ta' kura b'OB waħdu (5.6 pazjent b'effett għal kull 100 sena ta' pazjent).
English: • inflamed sinuses
Maltese: Twissijiet u prekawzjonijiet
English: Rarely, you may get an infection at a place where an individual injection was given.
Maltese: Rarament, tista' taqbdek infezzjoni f'post fejn ingħatat injezzjoni individwali.
English: b. Tabulated list of adverse reactions
Maltese: Lista f'tabella ta' reazzjonijiet avversi
English: Roche Products (Ireland) Ltd. Tel: +353 (0) 1 469 0700
Maltese: Tel: +353 (0) 1 469 0700
English: • dry skin
Maltese: U LUŻU
English: Administration of Fuzeon to non-HIV-1 infected individuals may induce anti-enfuvirtide antibodies that cross-react with HIV gp41.
Maltese: L-għoti ta' Fuzeon lil individwi li m'humiex infettati b'HIV-1 tista' twassal għal anti-korpi antienfuvirtide li jkollhom reazzjoni inkroċjata ma' HIV gp41.
English: Less than 13% of the dose was removed during haemodialysis.
Maltese: Inqas minn 13% tad-doża tneħħiet waqt l-emodijalisi.
English: NAME OF THE MEDICINAL PRODUCT Fuzeon 90 mg/ml powder and solvent for solution for injection
Maltese: Fuzeon 90 mg/ml trab u solvent għal soluzzjoni għall-injezzjoni
English: In HIV-infected patients with severe immune deficiency at the time of initiation of combination antiretroviral therapy (CART), an inflammatory reaction to asymptomatic or residual opportunistic infections may arise.
Maltese: F'pazjenti nfetti b'HIV b'defiċjenza immuni severa fil-ħin li tinbeda t-terapija antiretrovirali kombinata (CART), tista' sseħħ reazzjoni infjammatorja għall-infezzjonijiet mingħajr sintomi jew infezzjonijiet residwali opportunistiċi.
English: Step A: Getting Started
Maltese: Pass E:
English: Fuzeon can cause a build-up of a type of protein, called amyloid, under the skin at the injection site.
Maltese: Fuzeon jista' jikkawża akkumulazzjoni ta' tip ta' proteina imsejħa amilojde, taħt il-ġilda fis-sit talinjezzjoni.
English: EXP
Maltese: Trab
English: Patients with chronic hepatitis B or C and treated with anti-HIV therapy are at an increased risk for serious liver problems.
Maltese: Pazjenti b'epatite B jew Ċ kronika u kkurati b'terapija kontra l-HIV huma f'riskju akbar ta' problemi serji fil-fwied.
English: Fuzeon has been shown not to interact with your other anti-HIV medicines or rifampicin (an antibiotic).
Maltese: Fuzeon intwera li m'għandux effett fuq il-mediċini l-oħra kontra l-HIV tiegħek jew fuq rifampiċin (antibijotiku).
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation:
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI /TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni:
English: The relationship between the in vitro susceptibility of HIV-1 to enfuvirtide and inhibition of HIV-1 replication in humans has not been established.
Maltese: Enfuvirtide waqqaf ukoll il-fużjoni bejn ċellula u oħra medjata millenvelop ta' HIV-1.
English: • nightmares
Maltese: • dijabete
English: Interaction studies have only been performed in adults.
Maltese: Studji ta' interazzjoni twettqu biss fl-adulti.
English: C.
Maltese: b.
English: Patients developing signs/symptoms of a systemic hypersensitivity reaction should discontinue enfuvirtide treatment and should seek medical evaluation immediately.
Maltese: Il-pazjenti li jiżviluppaw sinjali/sintomi ta' reazzjoni sistematika ta' sensittività eċċessiva għandhom iwaqqfu l-kura b'enfuvirtide u għandhom jagħmlu evalwazzjoni medika minnufih.
English: Renal impairment: Analysis of plasma concentration data from patients in clinical trials indicated that the clearance of enfuvirtide is not affected to any clinically relevant extent in patients with mild to moderate renal impairment.
Maltese: Indeboliment tal-kliewi: Analiżi ta' riżultati ta' konċentrazzjoni fil-plażma minn pazjenti fi provi kliniċi indikat li t-tneħħija ta' enfuvirtide m'hijiex affettwata b'mod klinikament rilevanti f'pazjenti b'indeboliment renali ħafif sa moderat.
English: UNIQUE IDENTIFIER - HUMAN READABLE DATA PC:
Maltese: Studji f'Pazjenti b'Esperjenza Antiretrovirali:
English: Safety Tips
Maltese: Fejn Tinjetta
English: Fuzeon must be taken as part of a combination regimen.
Maltese: Fuzeon għandu jittieħed bħala parti minn programm ta' kura kombinata.
English: • you have chronic hepatitis B or C or another liver disease - you are more likely to get serious liver problems while using this medicine
Maltese: ● għandek epatite B jew Ċ kronika jew marda oħra tal-fwied - inti aktar probabbli li jkollok problemi serji fil-fwied waqt li tkun qed tuża din il-mediċina
English: Ecchymosis g g aAny severity grade.
Maltese: Is-sinjali u s-sintomi ġeneralment damu għal jew anqas minn sebat ijiem.
English: Studies in guinea pigs indicated a potential for enfuvirtide to produce delayed contact hypersensitivity.
Maltese: Studji fuq il-fniek ta' l-Indi jindikaw potenzjal li enfuvirtide jipproduċi sensittività eċċessiva ttardjata għal kuntatt.
English: • Allergic reaction (hypersensitivity) - signs may include: rash, a high temperature or chills,
Maltese: ● Reazzjoni allerġika (sensittività eċċessiva) - sinjali jistgħu jinkludu: raxx, temperatura għolja jew sirdat, dardir jew rimettar, għaraq jew rogħda.
English: Nodules and cysts e e
Maltese: Is-siringi tiegħek
English: Induration d d
Maltese: ANNESS II
English: See further instructions on how to use Fuzeon at the end of this leaflet (see Section 7).
Maltese: Ara aktar struzzjonijiet dwar kif għandek tuża Fuzeon fl-aħħar ta' dan il-fuljett (ara Sezzjoni 7).
English: Pick up the 3 ml large syringe.
Maltese: Oħroġ s-siringa mill-kunjett.
English: NAME OF THE MEDICINAL PRODUCT Fuzeon 90 mg/ml powder for solution for injection Enfuvirtide
Maltese: Fuzeon 90 mg/ml trab għal soluzzjoni għall-injezzjoni Enfuvirtide
English: 10 capsules
Maltese: 10 kapsuli
English: Study 065
Maltese: Studju 065
English: Study 396
Maltese: Studju 396
English: • The active substance is topotecan.
Maltese: • Is-sustanza attiva hi topotecan.
English: [n = 9]) (see section 4.5).
Maltese: [n = 9]) (ara sezzjoni 4.5).
English: 3 years.
Maltese: 3 snin.
English: Capsule contents Hydrogenated vegetable oil Glyceryl monostearate
Maltese: Il-kontenut tal-kapsula Hydrogenated vegetable oil Glyceryl monostearate
English: Table 2 Study results Study GOG-0179
Maltese: Tabella 2 Riżultati tal-istudju GOG-0179
English: Age/weight
Maltese: Età/piż
English: Each blister contains 10 capsules.
Maltese: Kull blister fiha 10 kapsuli.
English: Elm Park, Merrion Road Dublin 4
Maltese: Elm Park, Merrion Road
English: Date of first authorisation: 12 November 1996 Date of latest renewal: 20 November 2006
Maltese: 12 ta' Novembru 1996 Data tal-aħħar tiġdid: 20 ta' Novembru 2006
English: GlaxoSmithKline Manufacturing S.p.A, Strada Provinciale Asolana 90, 43056 San Polo di Torrile, Parma, Italy.
Maltese: GlaxoSmithKline Manufacturing S.p.A, Strada Provinciale Asolana 90, 43056 San Polo di Torrile, Parma, L-Italja.
English: 90429 Nuremberg Germany
Maltese: 90429 Nuremberg Il-Ġermanja
English: Novartis Pharma GmbH, Roonstrasse 25, D-90429 Nuremberg, Germany
Maltese: Novartis Pharma GmbH, Roonstrasse 25, D-90429 Nuremberg, Il-Ġermanja
English: Camberley, Surrey GU16 7SR United Kingdom
Maltese: Camberley, Surrey GU16 7SR Ir-Renju Unit
English: Do not take Hycamtin:
Maltese: Tiħux Hycamtin:
English: Combination therapy (cervical carcinoma):
Maltese: Terapija kkombinata (karċinoma ċervikali):
English: Novartis Pharmaceuticals UK Limited, Frimley Business Park, Frimley, Camberley, Surrey GU16 7SR, United Kingdom
Maltese: Novartis Pharmaceuticals UK Limited, Frimley Business Park, Frimley, Camberley, Surrey GU16 7SR, Ir-Renju Unit
English: Concentrated ammonia solution Potassium hydroxide
Maltese: Soluzzjoni konċentrata tal-ammonia Potassium hydroxide
English: Hypersensitivity reaction including rash
Maltese: Reazzjoni ta' sensittività eċċessiva inkluż raxx
English: 9/l) in 25% of patients (8% of courses); moderate (platelets between 25.0 and
Maltese: 9/l) f'25 % tal-pazjenti (8 % tal-korsijiet); moderata (plejtlits bejn 25.0