qanastek/EMEA-V3 huggingface dataset:
Rifabutin (300 mg once daily) decreased the Cmax and AUCτ of voriconazole at 200 mg twice daily by 69% and 78%, respectively.
Rifabutin (300 mg darba kuljum) naqqas Cmax u AUC ta 'voriconazole f' doża ta' 200 mg darbtejn kuljum b' 69% u 78%, rispettivament.
Careful monitoring of full blood counts and adverse reactions to rifabutin (e. g. uveitis) is recommended when rifabutin is coadministered with voriconazole.
Huwa rakkomandat monitoraġġ bir- reqqa ta 'l- għadd sħiħ ta' ċelloli bojod u ħomor fid - demm u tar- reazzjonijiet avversi għal rifabutin (ngħidu aħna uveite) meta rifabutin jiġi amministrat flimkien ma 'voriconazole.
Antiretroviral Agents:
76 Aġenti antiretrovirali:
In the
Efavirenz stabbli (400 mg b' mod orali darba kuljum) naqqas Cmax u AUC stabbli ta 'voriconazole b' medja ta' 61% u 77%, rispettivament, f' suġġetti b' saħħithom.
72 same study voriconazole at steady state increased the steady state Cmax and AUCτ of efavirenz by an average of 38% and 44% respectively, in healthy subjects.
Fl- istess studju, voriconazole stabbli żied l- Cmax u AUCstabbli ta 'efavirenz b' medja ta' 38% u 44% rispettivament, f' suġġetti adulti.
In a separate study in healthy subjects, voriconazole dose of 300 mg BID in combination with low dose efavirenz (300 mg once daily) did not lead to sufficient voriconzole exposure.
Fi studju separat f’ suġġetti f’ saħħithom, doża ta ’ 300 mg ta ’ voriconazole BID ma doża baxxa ta ’ efavirenz (300 mg darba kuljum) ma wasslitx għal esposizzjoni suffiċjenti ta ’ voriconazole.
When voriconazole is coadministered with efavirenz, voriconazole maintenance dose should be increased to 400 mg twice daily and the efavirenz dose should be reduced by 50%, i. e. to 300 mg once daily (See section 4.2).
Meta voriconazole jiġi amministrat flimkien ma 'efavirenz, id- doża ta' manteniment ta 'voriconazole għandha tiżdied għal 400 mg darbtejn kuljum u d- doża ta' efavirenz għandha titnaqqas b' 50%, jiġifieri għal 300 mg darba kuljum (ara sezzjoni 4. 2).
4.6 Pregnancy and lactation
77 4. 6 Tqala u Treddigħ
This represents a heterogeneous population, containing patients with haematological malignancy, HIV infected patients with oesophageal candidiasis and refractory 73 fungal infections, non-neutropenic patients with candidaemia or aspergillosis and healthy volunteers.
Din tirrappreżenta popolazzjoni eteroġenea, li tinkludi pazjenti b' tumuri ematoloġiċi, pazjenti infettati bl- HIV b' candidiasis esofagali u infezzjonijiet fungali refrettarji, pazjenti mhux newtropeniċi b' candidaemia jew asperġillosi u voluntiera b' saħħithom.
Undesirable effects reported in subjects receiving voriconazole:
78 Effetti mhux mixtieqa rrapportati f' suġġetti li kienu qegħdin jirċeivu voriconazole
74 Ear and labyrinth disorders Rare Hypoacusis, tinnitus
Mard tal- widnejn u tas- sistema labirintika Rari Hypoacusis, żanżin fil- widnejn
Renal and urinary disorders Common Uncommon Rare
79 Mard tal- kliewi u tas- sistema urinarja Komuni Mhux komuni Rari
75 Immune system disorders Common Uncommon
Mard tas- sistema immuni
Altered taste perception In the combined data from three bioequivalence studies using the powder for oral suspension formulation, treatment related taste perversion was recorded in 12 (14%) of subjects.
80 Perċezzjoni mibdula tat- togħma Fid- dejta kkombinata minn tliet studji ta 'bijoekwivalenza fejn intużat il- formulazzjoni tat- trab għal suspensjoni orali, kienet irreġistrata perverżjoni tat- togħma relatata mal- kura fi 12 (14%) - il suġġett.
These visual disturbances were transient and fully reversible, with the majority spontaneously resolving within 60 minutes and no clinically significant long-term visual effects were observed.
F' testijiet kliniċi, b' kura kemm fuq perjodu qasir kif ukoll fuq perjodu twil, madwar 30% tas- suġġetti esperjenzaw perċezzjoni viżwali mibdula/ mkabbra, vista mċajpra, tibdil fil- vista tal- kulur jew fotofobija. dawn id- disturbi viżwali ma damux u kompletament riversibbli, bil- maġġoranza jmorru b' mod spontanju fi żmien 60 minuta u ma kienu osservati ebda effetti viżwali klinikament sinifikanti fuq perjodu fit- tul.
76 Paediatric Use The safety of voriconazole was investigated in 245 paediatric patients aged 2 to < 12 years who were treated with voriconazole in pharmacokinetic studies (87 paediatric patients) and in compassionate use programs (158 paediatric patients).
Użu pedjatriku Is- sigurtà ta 'voricoanzole ġiet studjata f' 245 pazjent pedjatriku fl- etajiet ta' 2 sa < 12- il sena li kienu kkurati b' voriconazole fi studji farmakokinetiċi (87 pazjent pedjatriku) u fi programmi ta 'użu ħanin (158 pazjent pedjatriku).
4.9 Overdose
81 4. 9 Doża eċċessiva
A single adverse reaction of photophobia of 10 minutes duration was reported.
Kien irrapportat episodju avvers wieħed ta 'fotofobija li dam 10 minuti.
77 Other treated fungal infections (with often partial or complete response) included isolated cases of Alternaria spp., Blastomyces dermatitidis, Blastoschizomyces capitatus, Cladosporium spp., Coccidioides immitis, Conidiobolus coronatus, Cryptococcus neoformans, Exserohilum rostratum, Exophiala spinifera, Fonsecaea pedrosoi, Madurella mycetomatis, Paecilomyces lilacinus, Penicillium spp. including P. marneffei, Phialophora richardsiae, Scopulariopsis brevicaulis and Trichosporon spp. including T. beigelii infections.
Infezzjonijiet fungali oħra kkurati (b' rispons sikwit parzjali jew sħiħ) kienu jinkludu każi iżolati ta 'Alternaria spp., Blastomyces dermatitidis, Blastoschizomyces capitatus, Cladosporium spp., Coccidioides immitis, Conidiobolus coronatus, Cryptococcus neoformans, Exserohilum rostratum, Exophiala spinifera, Fonsecaea pedrosoi, Madurella mycetomatis, Paecilomyces lilacinus, Penicillium spp. fosthom P. marneffei, Phialophora richardsiae, Scopulariopsis brevicaulis u Trichosporon spp. fosthom T. infezzjonijiet beigelii.
In vitro activity against the following pathogens has been shown, but the clinical significance is unknown:
Kienet murija attività in vitro kontra l- patoġeni li ġejjin, iżda l- importanza klinika mhix magħrufa:
Specimens for fungal culture and other relevant laboratory studies (serology, histopathology) should be obtained prior to therapy to isolate and identify causative organisms.
82 Kampjuni għal koltura fungali u studji oħra rilevanti fil- laboratorju (seroloġija, istopatoloġija) għandhom jiġu miksuba qabel it- terapija sabiex jiġu iżolati u identifikati organiżmi kawżattivi.
A satisfactory global response (complete or partial resolution of all attributable symptoms/ signs, radiographic/ bronchoscopic abnormalities present at baseline) was seen in 53% of voriconazole-treated patients compared to 31% of patients treated with comparator.
Intwera rispons globali sodisfaċenti (għajbien sħiħ jew parzjali tas- sinjali kollha tas- sintomi attribwibbli, anormalitajiet radjugrafiċi/ bronkoskopiċi preżenti fil- linja bażi) fi 53% tal- pazjenti kkurati b' voriconazole meta mqabbel mal- 31% tal- pazjenti kkurati bil- komparatur.
In the primary analysis, successful response as assessed by a Data Review Committee (DRC) blinded to study medication was defined as resolution/ improvement in all clinical signs and symptoms of infection with eradication of Candida from blood and infected deep tissue sites at 12 weeks after the
Fl- analiżi primarja, rispons ta 'suċċess kif stmat minn Kumitat ta' Valutazzjoni tad- Dejta (DRC - Data Review Committee) li ma kienx jaf x' medikazzjoni ntużat fl - istudju ġie mfisser bħala għajbien/ titjib fis- sinjali u s- sintomi kliniċi kollha ta 'l- infezzjoni bil- qerda ta' Candida mid- demm u t- tessut fond infettat 12- il ġimgħa wara t- tmiem tat- terapija (EOT).
Timepoint _
Punt taż- żmien
Experience in paediatric patients Sixty-one paediatric patients aged 9 months up to 15 years who had definite or probable invasive fungal infections, were treated with voriconazole.
Esperjenza f' pazjenti pedjatriċi Wieħed u sittin pazjent pedjatriku ta 'bejn 9 xhur u 15- il sena li kellhom infezzjonijiet fungali invażivi ċerti jew probabbli, ingħataw kura b' voriconazole.
79 The majority (57/ 61) had failed previous antifungal therapies.
Il- maġġoranza tagħhom (57/ 61) kienu fallew terapiji antifungali preċedenti.
Clinical Studies Examining QT Interval A placebo-controlled, randomized, single-dose, crossover study to evaluate the effect on the QT interval of healthy volunteers was conducted with three oral doses of voriconazole and ketoconazole.
84 Studji Kliniċi li Eżaminaw l- Intervall QT Studju tat- tip crossover ta 'doża waħda kkontrollat bil- plaċebo, magħmul b' mod każwali biex jiġi valutat l- effett fuq l- intervall QT ta' voluntiera b' saħħithom ġie mwettaq bi tliet dożi orali ta 'voriconazole u ketoconazole.
Bioequivalence was established between the 200mg tablet and the 40 mg/ ml oral suspension when administered as a 200 mg dose.
Kienet stabbilita bijoekwivalenza bejn il- pillola ta '200mg u s- suspensjoni orali ta' 40mg/ ml meta mogħtija bħala doża ta '200 mg.
When multiple doses of voriconazole oral suspension are administered with high fat meals, Cmax and AUCτ are reduced by 58% and 37% respectively.
Meta dożi multipli tas- suspensjoni orali ta 'voriconazole jingħataw ma' ikliet b' kontenut għoli ta 'xaħam, Cmax u AUC jitnaqqsu bi 58% u 37% rispettivament.
80 In vivo studies indicated that CYP2C19 is significantly involved in the metabolism of voriconazole.
Studji in vivo indikaw li CYP2C19 huwa involut b' mod sinifikanti fil- metaboliżmu ta 'voriconazole.
Subjects who are heterozygous extensive metabolisers have on average 2- fold higher voriconazole exposure than their homozygous extensive metaboliser counterparts.
85 għandhom, bħala medja, esponiment għal voriconazole darbtejn ogħla mill- metabolizzaturi emozigoti estensivi.
81 In the therapeutic studies no dosage adjustment was made on the basis of age.
Kienet osservata relazzjoni bejn il- konċentrazzjonijiet fil- plasma u l- età.
A relationship between plasma concentrations and age was observed. The safety profile of voriconazole in young and elderly patients was similar and, therefore, no dosage adjustment is necessary for the elderly (see section 4.2).
Il- profil tas- sigurtà ta 'voriconazole f' pazjenti żgħażagħ u anzjani kien simili u, għalhekk, mhux meħtieġ aġġustament tad- doża għall- anzjani (ara sezzjoni 4. 2).
Paediatric The recommended oral dose in paediatrics is based on a population pharmacokinetic analysis of data obtained from 47 immunocompromised paediatric patients aged 2 to < 12 years old who were evaluated in a pharmacokinetic study examining multiple oral suspension doses of 4 and 6 mg/ kg twice daily.
86 Tfal Id- doża orali rakkomandata fit- tfal hija bbażata fuq analiżi farmakokinetika tal- popolazzjoni ta 'dejta miksuba minn 47 pazjent pedjatriku immunokompromess fl- etajiet ta' 2 sa < 12- il sena li ġew evalwati fi studju farmakokinetiku li eżamina dożi multipli ta 'suspensjoni orali ta' 4 u 6 mg/ kg darbtejn kuljum.
82 6.
87 6.
Sucrose Silica, Colloidal Titanium Dioxide (E171) Xanthan Gum Sodium Citrate Sodium Benzoate (E211) Citric Acid Natural Orange Flavour (containing orange oil, maltodextrin and tocopherol)
Sucrose Silica, Colloidal Titanium Dioxide (E171) Xanthan Gum Sodium Citrate Sodium Benzoate (E211) Citric Acid Togħma ta 'Larinġ Naturali (fih żejt tal- larinġ, maltodextrin u tocopherol)
The shelf-life of the powder for oral suspension is 2 years.
6. 2 Inkompatibilitajiet
The shelf-life of the constituted suspension is 14 days.
It- trab għal suspensjoni orali jdum tajjeb sentejn.
Constituted suspension:
Suspensjoni kostitwita:
Do not store above 30°C, do not refrigerate or freeze.
Taħżinx f' temperatura 'l fuq minn 30°C, tpoġġix fil- friġġ jew fil- friża.
Store at 2°C -8°C (in a refrigerator) before constitution.
Aħżen f' temperatura ta '2°C - 8°C (fi friġġ) qabel rikostituzzjoni.
For storage conditions of the constituted suspension see section 6.3.
Għall- kondizzjonijiet ta 'ħażna tas- suspensjoni kostitwita ara sezzjoni 6. 3.
Keep the container tightly closed.
Żomm ir- reċipjent magħluq sewwa.
One 100 ml high-density polyethylene (HDPE) bottle (with a polypropylene child resistant closure) contains 45 g of powder for oral suspension.
Flixkun ta '100ml magħmul minn politin ta' densità għolja (HDPE) (b' għeluq tal- polipropelin reżistenti għat- tfal) jesa '45 g ta' trab għal suspensjoni orali.
Following constitution, the volume of the suspension is 75 ml, providing a usable volume of 70 ml.
Wara li tiġi kostitwita, il- volum tas - suspensjoni jkun 75 ml, li jipprovdi volum użabbli ta '70 ml.
A measuring cup (graduated to indicate 23 ml), 5 ml oral syringe and a press-in bottle adaptor are also provided.
Huma pprovduti wkoll kikkra tal- kejl (gradata biex tindika 23 ml), siringa orali ta '5 ml u adapter press- in għall- flixkun.
Pack size:
Daqs tal- pakkett: flixkun wieħed.
Tap the bottle to release the powder.
Tektek il- flixkun biex joħroġ it- trab.
Measure 23 ml of water by filling the measuring cup to the top of the marked line.
Kejjel 23 ml ta 'ilma billi timla l- kikkra tal- kejl sax- xifel tal- linja mmarkata.
Add the water to the bottle.
Żid l- ilma mal - flixkun.
Using the cup measure another 23 ml of water and add this to the bottle.
Kejjel bil- kikkra 23 ml oħra ta 'ilma u żid dawn mal- flixkun.
Shake the closed bottle vigorously for about 1 minute.
Ħawwad il- flixkun magħluq bis- saħħa għal madwar minuta.
Remove child-resistant cap.
Neħħi t- tapp reżistenti għat- tfal.
Press bottle adaptor into the neck of the bottle.
Agħfas l- adapter tal- flixkun fil- għonq tal- flixkun.
Replace the cap.
Erġa 'poġġi t- tapp.
Write the date of expiration of the constituted suspension on the bottle label (the shelf-life of the constituted suspension is 14 days).
Ikteb id- data ta 'skadenza tas- suspensjoni kostitwita fuq it- tikketta tal- flixkun (iż- żmien kemm iddum tajba s- suspensjoni kostitwita huwa 14- il jum).
83 Instructions for use:
88 Struzzjonijiet dwar l- użu
Shake the closed bottle of constituted suspension for approximately 10 seconds before each use.
Ħawwad il- flixkun magħluq tas- suspensjoni kostitwita għal madwar 10 sekondi qabel kull użu.
Once constituted, VFEND oral suspension should only be administered using the oral syringe supplied with each pack.
Ladarba tkun kostitwita, is- suspensjoni orali VFEND għandha tingħata biss bis- siringa orali pprovduta ma 'kull pakkett.
Refer to the patient leaflet for more detailed instructions for use.
Irreferi għall- fuljett tal- pazjent għal struzzjonijiet aktar dettaljati dwar l - użu.
84 ANNEX II
89 ANNESS II
85 A.
90 A.
MANUFACTURING AUTHORISATION HOLDERS RESPONSIBLE FOR BATCH RELEASE Name and address of the manufacturers responsible for batch release
DETENTURI TA ’ L- AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI GĦALL- ĦRUĠ TAL- LOTT
Tablets Pfizer Manufacturing Deutschland GmbH Heinrich-Mack-Str.
Pilloli Pfizer Manufacturing Deutschland GmbH Heinrich- Mack- Str.
Powder for solution for infusion and powder for oral suspension:
Trab għal soluzzjoni għall- infużjoni u trab għal suspensjoni orali:
Pfizer PGM Zone Industrielle 29 Route des Industries 37530 Pocé-Sur-Cisse France
Pfizer PGM Zone Industrielle 29 Route des Industries 37530 Pocé- Sur- Cisse Franza
The Marketing Authorisation Holder will continue to submit yearly PSURs, unless otherwise specified by the CHMP.
Id- Detentur Ta ’ L- Awtorizzazzjoni Għat- tqegħid fis- suq ser ikompli jissottometti PSURs fuq bażi annwali, sakemm mhux specifikat mod iehor mis - CHMP.
86 ANNEX III LABELLING AND PACKAGE LEAFLET
91 ANNESS III
88 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
93 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Blister pack for 50 mg film-coated tablets – Pack of 2, 10, 14, 20, 28, 30, 50, 56, 100
Pakkett folji għal pilloli ta '5 mg miksijin b' rita – Pakkett ta' 2, 10, 14, 20, 28, 30, 50, 56, 100
VFEND 50 mg film-coated tablets Voriconazole
VFEND 50 mg pilloli miksijin b' rita Voriconazole
Includes lactose monohydrate.
Lactose Monohydrate
2, 10, 14, 20, 28, 30, 50, 56 or 100 film-coated tablets
2, 10, 14, 20, 28, 30, 50, 56 jew 100 miksijin b' rita
Read enclosed leaflet before use.
Aqra l- fuljett ta 'tagħrif qabel l- użu
Sealed Pack Do not use if box has been opened
Tużax jekk il- pakket kien imfetaħ.
Pfizer Limited Sandwich Kent, CT13 9NJ, United Kingdom
Pfizer Limited Sandwich Kent, CT13 9NJ, Ir- Renju Unit
2 tabs:
2 pilloli:
EU/ I/ 02/ 212/ 001 10 tabs:
EU/ I/ 02/ 212/ 001 10 pilloli:
EU/ I/ 02/ 212/ 002 14 tabs:
EU/ I/ 02/ 212/ 002 14- il pillola:
EU/ I/ 02/ 212/ 003 20 tabs:
EU/ I/ 02/ 212/ 003 20 pillola:
EU/ I/ 02/ 212/ 004 28 tabs:
EU/ I/ 02/ 212/ 004 28 pillola:
EU/ I/ 02/ 212/ 005 30 tabs:
EU/ I/ 02/ 212/ 005 30 pillola:
EU/ I/ 02/ 212/ 006 50 tabs:
EU/ I/ 02/ 212/ 006 50 pillola:
EU/ I/ 02/ 212/ 007 56 tabs:
EU/ I/ 02/ 212/ 007 56 pillola:
EU/ I/ 02/ 212/ 008 100 tabs:
EU/ I/ 02/ 212/ 008 100 pillola:
90 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
95 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ L- ISTRIXXI JEW FUQ IL- FOLJI
Blister foil for 50 mg film-coated tablets (all blister packs)
Fojl tal- folji għal 50 mg pilloli miksijin b' rita (il- pakketti tal- folji kollha)
Pfizer Ltd (as MA Holder logo)
Pfizer Ltd (as MA Holder logo)
91 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
96 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Bottle outer pack for 50 mg film-coated tablets – Pack of 2, 30, 100
Pakkett ta 'barra tal- flixkun għal pilloli ta' 50 mg miksijin b' rita – Pakkett ta '2, 30, 100
Includes lactose monohydrate
Lactose Monohydrate
2, 30 or 100 film-coated tablets
2, 30 jew 100 pillola miksijin b' rita
Oral use Read enclosed leaflet before use.
Aqra l- fuljett ta 'tagħrif qabel l- użu
EU/ I/ 02/ 212/ 010 30 tabs:
EU/ I/ 02/ 212/ 010 30 pillola:
EU/ I/ 02/ 212/ 011 100 tabs:
EU/ I/ 02/ 212/ 011 100 pillola:
93 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
98 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA U L- PAKKETT LI JMISS MAL- PRODOTT
Bottle label for 50 mg film-coated tablets – Pack of 2, 30, 100
Pakkett ta 'barra tal- flixkun għal pilloli ta' 50 mg miksijin b' rita – Pakkett ta '2, 30, 100
VFEND 50 mg film-coated tablets Voriconazole Oral use
VFEND 50 mg pilloli miksijin b' rita Voriconazole Użu orali.
2 (30, 100) film-coated tablets Each tablet contains 50 mg voriconazole
2 (30, 100) pilloli miksijin b' rita Kull pillola fiha 50 mg ta 'voriconazole.
Medicinal product subject to medical prescription Keep out of the reach and sight of children.
Prodott mediċinali li jingħata bir- riċetta tat- tabib.
Read enclosed leaflet before use.
Żommu fejn ma jintlaħaqx u ma jidhirx mit- tfal.
EU/ I/ 02/ 212/ 010 (EU/ I/ 02/ 212/ 011 30 tabs) (EU/ I/ 02/ 212/ 012 100 tabs)
EU/ I/ 02/ 212/ 010 (EU/ I/ 02/ 212/ 011 30 pillola) (EU/ I/ 02/ 212/ 012 100 pillola)
Blister pack for 200 mg film-coated tablets – Pack of 2, 10, 14, 20, 28, 30, 50, 56, 100
Pakkett folji għal pilloli ta '200 mg miksijin b' rita – Pakkett ta' 2, 10, 14, 20, 28, 30, 50, 56, 100
VFEND 200 mg film-coated tablets Voriconazole
VFEND 200 mg pilloli miksijin b' rita Voriconazole
2, 10, 14, 20, 28, 30, 50, 56 or 100 film-coated tablets
2, 10, 14, 20, 28, 30, 50, 56 jew 100 pillola miksijin b' rita
Sealed Pack Do not use if box has been opened
Tużax jekk il- pakkett kien imfetaħ.
95 10.
100 10.
EU/ I/ 02/ 212/ 013 10 tabs:
EU/ I/ 02/ 212/ 013 10 pilloli:
EU/ I/ 02/ 212/ 014 14 tabs:
EU/ I/ 02/ 212/ 014 14- il pillola:
EU/ I/ 02/ 212/ 015 20 tabs:
EU/ I/ 02/ 212/ 015 20 pillola:
EU/ I/ 02/ 212/ 016 28 tabs:
EU/ I/ 02/ 212/ 016 28 pillola:
EU/ I/ 02/ 212/ 017 30 tabs:
EU/ I/ 02/ 212/ 017 30 pillola:
EU/ I/ 02/ 212/ 018 50 tabs:
EU/ I/ 02/ 212/ 018 50 pillola:
EU/ I/ 02/ 212/ 019 56 tabs:
EU/ I/ 02/ 212/ 019 56 pillola:
EU/ I/ 02/ 212/ 020 100 tabs:
EU/ I/ 02/ 212/ 020 100 pillola:
96 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
101 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ L- ISTRIXXI JEW FUQ IL- FOLJI
Blister foil for 200 mg film-coated tablets (all blister packs)
Fojl tal- folji għal 200 mg pilloli miksijin b' rita (il- pakketti tal- folji kollha)
97 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
102 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Bottle outer pack for 200 mg film-coated tablets – Pack of 2, 30, 100
Pakkett ta 'barra tal- flixkun għal pilloli ta' 200 mg miksijin b' rita – Pakkett ta '2, 30, 100
EU/ I/ 02/ 212/ 022 30 tabs:
EU/ I/ 02/ 212/ 022 30 pillola:
EU/ I/ 02/ 212/ 023 100 tabs:
EU/ I/ 02/ 212/ 023 100 pillola:
99 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
104 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA U L- PAKKETT LI JMISS MAL- PRODOTT
Bottle label for 200 mg film-coated tablets – Pack of 2, 30 100
Pakkett ta 'barra tal- flixkun għal pilloli ta' 200 mg miksijin b' rita – Pakkett ta '2, 30, 100
VFEND 200 mg film-coated tablets Voriconazole Oral use
VFEND 200 mg pilloli miksijin b' rita Voriconazole Użu orali.
2 (30,100) film-coated tablets Each tablet contains 200 mg voriconazole.
2 (30, 100) pilloli miksijin b' rita Kull pillola fiha 200 mg ta 'voriconazole.
EU/ I/ 02/ 212/ 022 (EU/ I/ 02/ 212/ 023 30 tabs) (EU/ I/ 02/ 212/ 024 100 tabs)
EU/ I/ 02/ 212/ 022 (EU/ I/ 02/ 212/ 023 30 pillola) (EU/ I/ 02/ 212/ 024 100 pillola)
100 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
105 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
VFEND 200 mg powder for solution for infusion Voriconazole
VFEND 200 mg trab għal soluzzjoni għall- infużjoni Voriconazole
Equivalent to 10 mg/ ml voriconazole when reconstituted as recommended.
Ekwivalenti għal 10 mg/ ml ta 'voriconazole meta rikostitwit kif rakkomandat
Excipient: sulphobutylether beta cyclodextrin sodium
Sulphobutylether beta cyclodextrin sodium (SBECD)
1 vial of powder for solution for infusion Single use vial
Kunjett ta 'trab għal soluzzjoni għall- infużjoni Kunjett li jintuża darba biss
Reconstitute and dilute before use.
Irrikostitwixxi u iddilwa qabel ma tużah.
Intravenous use only Not for bolus injection Read enclosed leaflet before use
Aqra l- fuljett ta 'tagħrif qabel l- użu
Infuse at a maximum rate of 3mg/ kg per hour.
Erħi b' rata massima ta '3mg/ kg fis- siegħa.
Shelf life after reconstitution:
Żmien kemm idum tajjeb il- prodott wara rikostituzzjoni:
24 hours when stored at 2°C - 8°C
24 siegħa meta maħżun f' temperatura ta '2C
102 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
107 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA U L- PAKKETT LI JMISS MAL- PRODOTT
Label on the vial
Tikketta fuq il- kunjett
VFEND 200 mg powder for solution for infusion Voriconazole Intravenous use only Single use vial
VFEND 200 mg trab għal soluzzjoni għall- infużjoni Voriconazole Użu ġol- vini biss Kunjett li jintuża darba biss
Reconstitute and dilute before use – see leaflet.
Irrikostitwixxi u ddilwa qabel l- użu – ara l- fuljett.
200 mg per vial (10 mg/ ml) 1 vial
200 mg għal kull kunjett (10 mg/ ml) 1 kunjett
103 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
108 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
VFEND 40 mg/ ml powder for oral suspension Voriconazole
VFEND 40 mg/ ml trab għal suspensjoni orali Voriconazole
1 ml of the constituted suspension contains 40 mg voriconazole.
1 ml tas- suspensjoni kostitwita fih 40 mg voriconazole
Also contains sucrose.
Fih ukoll is- sucrose.
Each bottle contains 45g powder for oral suspension providing 70 ml of suspension when constituted.
Kull flixkun fih 45g trab għal suspensjoni orali li jipprovdi 70 ml ta 'suspensjoni meta kostitwit.
For oral use after constitution Shake bottle for approximately 10 seconds before use.
Ħawwad il- flixkun għal madwar 10 sekondi qabel l- użu.
Use the oral syringe provided in the pack to measure the correct dose.
Uża s- siringa orali pprovduta fil- pakkett biex tkejjel id- doża korretta.
Constitution instructions:
Struzzjonijiet dwar il- kostituzzjoni:
Tap the bottle to release the powder Add 46 ml of water and shake vigorously for about 1 minute Further dilution is not appropriate
Tektek il- flixkun biex joħroġ it- trab Żid 46 ml ta 'ilma u ħawwad bis- saħħa għal madwar minuta Iżżidx aktar ilma
104 8.
109 8.
Any remaining suspension should be discarded 14 days after constitution.
Kwalunkwe suspensjoni li jifdal għandha tiġi mormija 14- il jum wara li tkun ġiet kostitwita.
Powder for oral suspension: store at 2°C - 8°C (in a refrigerator) before constitution.
Taħżinx f' temperatura 'il fuq minn 30°C Tpoġġix fi friġġ jew friża
For the constituted oral suspension:
Żomm ir- reċipjent magħluq sew
Keep the container tightly closed
PREKAWZJONIJIET SPEĊJALI GĦAR- RIMI TA ’ PRODOTTI MEDIĊINALI MHUX UŻATI JEW SKART MINN DAWN IL- PRODOTTI MEDIĊINALI, JEKK HEMM BŻONN
SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE
Pfizer Limited Sandwich Kent, CT13 9NJ, Ir- Renju Unit
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
NUMRU( I) TA ’ L- AWTORIZZAZZJONI GĦAT- TQEGĦID FIS- SUQ
Pfizer Limited Sandwich Kent, CT13 9NJ, United Kingdom
EU/ I/ 02/ 212/ 026
MARKETING AUTHORISATION NUMBER(S)
NUMRU TAL- LOTT
EU/ I/ 02/ 212/ 026
Lott:
GENERAL CLASSIFICATION FOR SUPPLY
INFORMAZZJONI BIL- BRAILLE
Medicinal product subject to medical prescription
110 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT LI JMISS MAL- PRODOTT
15.
Flixkun
VFEND 40 mg/ ml
VFEND 40 mg/ ml trab għal suspensjoni orali Voriconazole
105 MINIMUM PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING
DIKJARAZZJONI TAS- SUSTANZA( I) ATTIVA( I)
Bottle
1 ml tas- suspensjoni kostitwita fih 40 mg voriconazole
NAME OF THE MEDICINAL PRODUCT
LISTA TA ’ SUSTANZI MHUX ATTIVI
VFEND 40 mg/ ml powder for oral suspension Voriconazole
Fih ukoll is- sucrose – ara il- fuljett għal aktar tagħrif.
STATEMENT OF ACTIVE SUBSTANCE(S)
GĦAMLA FARMAĊEWTIKA U KONTENUT
1 ml of the constituted suspension contains 40 mg voriconazole.
Kull flixkun fih 45g trab għal suspensjoni orali li jipprovdi 70 ml ta 'suspensjoni meta kostitwit.
LIST OF EXCIPIENTS
MOD TA ’ KIF U MNEJN JINGĦATA
Also contains sucrose – see leaflet for further information.
Ħawwad il- flixkun għal madwar 10 sekondi qabel l- użu.
PHARMACEUTICAL FORM AND CONTENTS
DATA TA ’ META JISKADI
Each bottle contains 45 g powder for oral suspension providing 70 ml of suspension when constituted.
Kwalunkwe suspensjoni li jifdal għandha tiġi mormija 14- il jum wara li tkun ġiet kostitwita.
5.
111 9.
METHOD AND ROUTE(S) OF ADMINISTRATION
Għas- suspensjoni orali kostitwita:
Use the oral syringe provided in the pack to measure the correct dose.
PREKAWZJONIJIET SPEĊJALI GĦAR- RIMI TA ’ PRODOTTI MEDIĊINALI MHUX UŻATI JEW SKART MINN DAWN IL- PRODOTTI MEDIĊINALI, JEKK HEMM BŻONN
SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE REACH AND SIGHT OF CHILDREN
ISEM U INDIRIZZ TAD- DETENTUR TA ’ L- AWTORIZZAZZJONI GĦAT- TQEGĦID FIS- SUQ
Keep out of the reach and sight of children.
Pfizer Limited Sandwich Kent, CT13 9NJ, Ir- Renju Unit
OTHER SPECIAL WARNING(S), IF NECESSARY
NUMRU( I) TA ’ L- AWTORIZZAZZJONI GĦAT- TQEGĦID FIS- SUQ
Any remaining suspension should be discarded 14 days after constitution.
14.
Expiry date of the constituted suspension:
KLASSIFIKAZZJONI ĠENERALI TA ’ KIF JINGĦATA
Powder for oral suspension: store at 2°C-8°C (in a refrigerator) before constitution.
Prodott mediċinali li jingħata bir- riċetta tat- tabib.
Do not store above 30°C.
15.
Do not refrigerate or freeze Keep the container tighly closed
STRUZZJONIJIET DWAR L- UŻU
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
INFORMAZZJONI BIL- BRAILLE
Pfizer Limited Sandwich Kent, CT13 9NJ, United Kingdom
[Ġustifikazzjoni għalfejn mhux ser jintuża il- Braille aċċettata]
12.
112 B.
BATCH NUMBER
FULJETT TA 'TAGĦRIF
Batch:
113 FULJETT TA ’ TAGĦRIF:
GENERAL CLASSIFICATION FOR SUPPLY
VFEND 50 mg pilloli miksijin b' rita VFEND 200mg pilloli miksijin b’ rita Voriconazole
Medicinal product subject to medical prescription
Aqra dan il- fuljett kollu qabel tibda tieħu din il- mediċina.
15.
- - -
INFORMATION IN BRAILLE
Żomm dan il- fuljett.
[Justification for not including Braille accepted.]
TAGĦTIHIEX lil ħaddieħor.
107 B.
-
INFORMATION FOR THE USER VFEND 50 mg film-coated tablets VFEND 200 mg film-coated tablets Voriconazole
Jekk xi wieħed mill- effetti kollaterali jiggrava, jew jekk tinnota xi effetti sekondarji li m’ humiex imsemmijin f’ dan il- fuljett, jekk jogħġbok għid lit- tabib jew lill- ispiżjar tiegħek.
Read all of this leaflet carefully before you start taking this medicine.  Keep this leaflet.
Qabel ma tieħu VFEND 3.
You may need to read it again.  If you have any further questions, ask your doctor or pharmacist.  This medicine has been prescribed for you.
Effetti sekondarji li jista ’ jkollu 5.
Do not pass it on to others.
Kif taħżen VFEND 6.
It may harm them, even if their symptoms are the same as yours.  If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell you doctor or pharmacist.
Aktar tagħrif
What VFEND is and what it is used for 2.
X' INHU VFEND U GĦALXIEX JINTUŻA
Before you take VFEND 3.
VFEND jappartjeni għal grupp ta 'mediċini msejħa aġenti antifungali triazole.
Possible side effects 5.
Dawn il- mediċini jintużaw sabiex jikkuraw varjetà wiesgħa ta 'infezzjonijiet fungali.
Further information
VFEND jaħdem billi joqtol jew iwaqqaf it- tkabbir tal- fungi li jikkawżaw l- infezzjonijiet.
WHAT VFEND IS AND WHAT IT IS USED FOR
Liema infezzjonijiet fungali huma kkurati b' VFEND?
VFEND belongs to a group of medicines called triazole antifungal agents.
Dan il- prodott għandu jittieħed biss taħt is- superviżjoni ta 'tabib.
These medicines are used to treat a wide variety of fungal infections.
VFEND huwa maħsub prinċipalment għal pazjenti morda serjament.
VFEND works by killing or stopping the growth of the fungi that cause infections.
QABEL MA TIEĦU VFEND
What fungal infections are treated with VFEND?
Tiħux VFEND:
VFEND is mainly for use in seriously ill patients.
- jekk inti allerġiku/ a (tbati minn sensittività eċċessiva) għal voriconazole jew sustanzi oħra ta '
BEFORE YOU TAKE VFEND
VFEND.
Do not take VFEND: -If you are allergic to voriconazole or any of the other ingredients of VFEND
Ċerti mediċini jaffettwaw il- mod kif jaħdem VFEND, jew VFEND jista 'jaffettwa l- mod kif jaħdmu huma.
It is very important that you inform your doctor or pharmacist if you are taking or have taken any other medicines, even those that are obtained without a prescription.
Lista tal- mediċini li jistgħu jaffettwaw lil VFEND tidher fis- sezzjoni ‘ Teħid ta 'mediċini oħra ma' VFEND ’.
Some medicines affect the way VFEND works, or VFEND may affect the way they work.
Madankollu, il- mediċini fil- lista segwenti m' għandhomx jintużaw waqt il- kura tiegħek b' VFEND:
However, the medicines in the following list must not be taken during your course of VFEND treatment:
 Terfenadine (użat għal allerġija)  Astemizole (użat għal allerġija)  Cisapride (użat għal problemi ta 'l- istonku)  Pimozide (użat għall- kura ta' mard mentali)
 Terfenadine (used for allergy)  Astemizole (used for allergy)  Cisapride (used for stomach problems)  Pimozide (used for treating mental illness)  Quinidine (used for irregular heart beat)  Rifampicin (used for treating tuberculosis)  Carbamazepine (used to treat seizures) 109  Phenobarbital (used for severe insomnia and seizures)  Ergot alkaloids (e. g. ergotamine, dihydroergotamine; used for migraine)  Sirolimus (used in transplant patients)  Ritonavir (used for treating HIV) in doses of 400mg and more twice daily  St John’ s Wort (herbal supplement)
John’ s Wort (fexfiex) (suppliment erbali)
Take special care with VFEND:
Oqgħod attent ħafna b' VFEND:
If you are known to have cardiomyopathy, irregular heart beat, slow heart rate or an abnormality of electrocardiogram (ECG) called ‘ long QT syndrome’.
jew anormalità ta 'l- elettrokardjogramm (ECG) imsejħa ‘ sindrome tal- QT twil ’.
Taking other medicines with VFEND:
Meta tieħu mediċini oħra:
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including those that are obtained without a prescription.
Jekk jogħġbok, għid lit- tabib jew lill- ispiżjar tiegħek jekk qiegħed tieħu jew ħadt dan l- aħħar xi mediċini oħra, anki dawk mingħajr riċetta.
Some medicines, when taken at the same time as VFEND, may affect the way VFEND works or VFEND may affect the way they work.
Ċerti mediċini, meta jittieħdu fl- istess ħin ma 'VFEND, jistgħu jaffettwaw il- mod kif jaħdem VFEND jew VFEND jista' jaffettwa l- mod kif jaħdmu huma.
Tell your doctor if you are taking any of the following medicines, as VFEND must not be taken if you are already taking any of these medicines (See also Section 2 above ‘ Do not take VFEND’):
Għid lit- tabib tiegħek jekk qed tieħu xi waħda mill- mediċini li ġejjin, billi VFEND m' għandux jittieħed jekk diġa 'qed tieħu xi waħda minn dawn il - mediċini (Ara wkoll Sezzjoni 2 fuq ‘ Tiħux VFEND ’):
 Terfenadine (used for allergy)  Astemizole (used for allergy)  Carbamazepine (used to treat seizures)  Cisapride (used for stomach problems)  Pimozide (used for treating mental illness)  Quinidine (used for irregular heart beat)  Rifampicin (used for treating tuberculosis)  Phenobarbital (used for severe insomnia and seizures)  Ergot alkaloids (e. g. ergotamine, dihydroergotamine; used for migraine)  Sirolimus (used in transplant patients)  Ritonavir (used for treating HIV) in doses of 400 mg and more twice daily  St John’ s Wort (herbal supplement)
 Terfenadine (użat għal allerġija)  Astemizole (użat għal allerġija)  Carbamazepine (użat għall- kura ta 'attakki ta' puplesija)  Cisapride (użat għal problemi ta 'l- istonku)  Pimozide (użat għall- kura ta' mard mentali)  Quinidine (użat għal taħbit tal- qalb irregolari)  Rifampicin (użat għall- kura tat- tuberkulosi)  Phenobarbital (użat għal nuqqas ta 'rqad sever u attakki ta' puplesija)  Alkalojdi ta 'l- ergotina (e. g. ergotamine, dihydroergotamine; użati għall- emigranja)  Sirolimus (użat f' pazjenti tat- trapjanti)  Ritonavir (użat għall- kura ta' l- HIV) f' dożi ta '400 mg u aktar darbtejn kuljum  St.
Tell your doctor if you are taking the following medicine, as treatment with VFEND at the same time should be avoided if possible:
John’ s Wort (fexfiex) (suppliment erbali)
 Ritonavir (used for treating HIV) in doses of 100 mg twice daily  Tell your doctor if you are taking either of the following medicines, as treatment with VFEND at the same time should be avoided if possible, and a dose adjustment of voriconazole may be required:  Rifabutin (used for treating tuberculosis)  Phenytoin (used to treat epilepsy)
Għid lit- tabib tiegħek jekk qed tieħu l- mediċina li ġejja, billi jekk ikun possibbli għandha tiġi evitata kura b' VFEND fl- istess ħin::  Ritonavir (użat għall- kura ta 'l- HIV) f' dożi ta' 100 mg u aktar darbtejn kuljum
Tell your doctor if you are taking any of the following medicines, as a dose adjustment or monitoring may be required to check that the medicines and/ or VFEND are still having the desired effect:
Għid lit- tabib tiegħek jekk qed tieħu xi waħda minn dawn iż- żewġ mediċini li ġejjin, billi jekk ikun possibbli għandha tiġi evitata kura b' VFEND fl- istess ħin, u jista 'jkun meħtieġ aġġustament fid- doża:  Rifampicin (użat għall- kura tat- tuberkulosi)  Phenytoin (użat għall- kura ta' l- epilessija)
 Warfarin and other anticoagulants (e. g. phenprocoumon, acenocoumarol; used to slow down clotting of the blood)  Ciclosporin (used in transplant patients)  Tacrolimus (used in transplant patients)  Sulphonylureas (e. g. tolbutamide, glipizide, and glyburide) (used for diabetes)  Statins (e. g. atorvastatin, simvastatin) (used for lowering cholesterol)  Benzodiazepines (e. g midazolam, triazolam) (used for severe insomnia and stress)  Omeprazole (used for treating ulcers)  Oral contraceptives (if you take VFEND whilst using oral contraceptives, you may get side effects such as nausea and menstrual disorders)
Għid lit- tabib tiegħek jekk qed tieħu xi waħda mill- mediċini li ġejjin, billi jista 'jkun meħtieġ aġġustament fid- doża jew monitoraġġ sabiex jiġi aċċertat li l- mediċini u/ jew VFEND ikunu għadhom qed ikollhom l- effett mixtieq:  Warfarin u sustanzi oħra kontra l- koagulazzjoni tad- demm (p. e. phenprocoumon, acenocoumarol; użati biex jirritardjaw it- tagħqid tad- demm)  Ciclosporin (użat f' pazjenti tat- trapjanti)  Tacrolimus (użat f' pazjenti tat- trapjanti)  Sulphonylureas (p. e. tolbutamide, glipizide, u glyburide) (użati għad- dijabete)  Statins (p. e. atorvastatin, simvastatin) (użati biex ibaxxu l- kolesterol)  Benzodiazepines (p. e. midazolam, triazolam) (użati għal nuqqas ta' rqad sever u stress)  Omeprazole (użat għall- kura ta 'l- ulċeri)
110  Vinca alkaloids (e. g. vincristine and vinblastine) (used in treating cancer)  Indinavir and other HIV protease inhibitors (used for treating HIV)  Non-nucleoside reverse transcriptase inhibitors (e. g. efavirenz, delavirdine, nevirapine) (used for treating HIV)  Methadone (used to treat heroin addiction)  Efavirenz (used for treating HIV) (some doses of efavirenz can NOT be taken at the same time as VFEND)  Alfentanil and other short acting opiates such as fentanyl and sufentanil (painkillers used for surgical procedures)  Non-steroidal anti-inflammatory drugs (e. g. ibuprofen, diclofenac) (used for treating pain and inflammation)
115  Kontraċettivi orali (jekk tieħu VFEND waqt li tkun qed tuża kontraċettivi orali, jista 'jkollok effetti mhux mixtieqa bħal dardir u disturbi mestrwali)  Alkalojdi vinka (p. e. vincristine u vinblastine) (użati fil- kura tal- kanċer)  Indinavir u inibituri oħra tal- protease ta' l- HIV (użati għall- kura ta 'l- HIV)  Non- nucleoside reverse transcriptase inhibitors (p. e. efavirenz, delavirdine, nevirapine) (użati għall- kura ta' l- HIV)  Methadone (użat għat- trattament tal- vizzju tat- teħid ta 'l- eroina)  Efavirenz (użat għat- trattament ta ’ l- HIV) (ċerti dożi ta ’ efavirenz MHUX suppost jittieħdu fl - istess ħin ma voriconazole)  Alfentanil u opiates oħra li jaħdmu fuq qasir żmien bħal fentanyl u sulfentanil (mediċini kontra l - uġiegħ li jintużaw għal proċeduri kirurġiċi)  Mediċini anti- infjammatorji non- sterojdali (e. ż. ibuprofen, diclofenac) (użati kontra l- uġigħ u infjammazzjoni)
Before being treated with VFEND, tell your doctor if:  you have had an allergic reaction to other azoles.  you are suffering from, or have ever suffered from liver disease.
Qabel ma tiġi kkurat b' VFEND, għid lit- tabib tiegħek:
If you have liver disease, your doctor may prescribe a lower dose of VFEND.
jista 'jordnalek doża aktar baxxa ta' VFEND.
Your doctor should also monitor your liver function while you are being treated with VFEND by doing blood tests.  you are already being treated with phenytoin (used to treat epilepsy).
Il- konċentrazzjoni ta '
Your blood concentration of phenytoin will need to be monitored during your treatment with VFEND and your dose may be adjusted.  you are already being treated with rifabutin (used for treating tuberculosis).
phenytoin fid- demm tiegħek trid tiġi mmonitorjata matul il- kura tiegħek b' VFEND u d- doża tiegħek tista 'tiġi aġġustata.
Your blood counts and side effects to rifabutin will need to be monitored.
- jekk diġa 'qed tiġi kkurat b' rifabutin (użat għall- kura tat- tuberkolosi).
While being treated with VFEND:  tell your doctor immediately if you develop a severe skin rash or blisters.  avoid sunlight while being treated with VFEND, as an increased sensitivity of skin to the sun’ s UV rays can occur.  your doctor should monitor the function of your liver and kidney by doing blood tests.
l- effetti sekondarji għal rifabutin iridu jiġu mmonitorjati.
Taking VFEND with food and drink:
Waqt li tkun qed tingħata kura b' VFEND:
VFEND tablets must be taken at least one hour before or one hour after a meal.
akbar tal- ġilda għar- raġġi UV tax- xemx.
Pregnancy and breast-feeding:
Meta tieħu VFEND ma 'l- ikel u max- xorb:
VFEND must not be taken during pregnancy, unless indicated by your doctor.
Tqala u Treddigħ VFEND m' għandux jittieħed waqt it- tqala, sakemm ma jkunx indikat mit- tabib tiegħek.
Effective contraception must be used in women of childbearing potential.
Għandha tintuża kontraċezzjoni effettiva fin- nisa li jistgħu jinqabdu tqal.
Contact your doctor immediately if you become pregnant while taking VFEND.
Ikkuntattja lit- tabib tiegħek immedjatament jekk tinqabad tqila jekk li tkun qed tieħu VFEND.
VFEND must not be taken during breast-feeding.
VFEND m' għandux jittieħed waqt li tkun qed tredda '.
Ask your doctor or pharmacist for advice before taking any medicine whilst breast-feeding.
Itlob il- parir tat- tabib jew ta ’ l- ispiżjar tiegħek qabel tieħu xi mediċina waqt li tkun qed tredda '.
VFEND may cause blurring of vision or uncomfortable sensitivity to light.
VFEND jista 'jikkawża vista mċajpra jew sensittività skomda għad- dawl.
While affected, do not drive or operate any tools or machines.
Issuqx jew tħaddem għodod jew magni waqt li tkun affettwat.
Contact your doctor if you experience this.
Ikkuntattja lit- tabib tiegħek jekk tesperjenza dan.
Important information about some of the ingredients of VFEND:
116 Tagħrif importanti dwar xi wħud mis- sustanzi ta 'VFEND:
VFEND tablets contain lactose.
Il- pilloli VFEND fihom il- lactose.
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking VFEND.
Jekk it- tabib tiegħek qallek li għandek xi intolleranza għal xi tipi ta 'zokkor, ikkuntattja lit- tabib tiegħek qabel ma tieħu VFEND.
HOW TO TAKE VFEND
KIF GĦANDEK TIEĦU VFEND
Always take VFEND exactly as your doctor has told you.
Dejjem għandek tieħu VFEND skond il- parir tat- tabib tiegħek.
You should check with your doctor or pharmacist if you are not sure.
Dejjem għandek taċċerta ruħek mat - tabib jew ma 'l- ispiżjar tiegħek jekk ikollok xi dubju/ a.
Your doctor will determine your dose depending on your weight and the type of infection you have.
It- tabib tiegħek jistabbilixxi d- doża tiegħek skond il- piż u t- tip ta 'infezzjoni li għandek.
111 The usual dose for adults (including elderly patients) is as follows:
 Id- doża normali għall- adulti (inkluż pazjenti anzjani) hija kif ġej:
Tablets Patients 40 kg and above Patients less than 40 kg Dose for the first 24 hours (Loading Dose)
Doża għall- ewwel 24 siegħa (Loading Dose)
400 mg every 12 hours for the first 24 hours
400 mg kull 12- il siegħa għall- ewwel 24 siegħa
mg every 12 hours the first 24 hours
200 mg kull 12- il siegħa għall- ewwel 24 siegħa
Dose after the first 24 hours (Maintenance Dose)
Doża wara l- ewwel 24 siegħa (Doża ta 'Manteniment)
200 mg twice a day
200 mg darbtejn kuljum
100 mg twice a day
100 mg darbtejn kuljum
Depending on your response to treatment, your doctor may increase the daily dose to 300 mg twice a day.
Skond ir- rispons tiegħek għall- kura, it- tabib tiegħek jista 'jżid id- doża tiegħek tal- ġurnata għal 300 mg darbtejn kuljum.
The doctor may decide to decrease the dose if you have mild to moderate cirrhosis.
It- tabib jista 'jiddeċiedi li jnaqqas id- doża jekk inti jkollok ċirrożi ħafifa għal moderata.
 The usual dose for children aged 2 to less than 12 years is 200 mg twice daily.  Tablets must only be given if the child is able to swallow tablets.
 Id- doża normali għal tfal minn 2 sa anqas minn 12- il sena hija 200 mg darbtejn kuljum.
VFEND should not be given to children younger than 2 years of age.
VFEND m' għandux jingħata lil tfal ta 'anqas minn sentejn.
Teenagers (aged 12 to 16 years) should be dosed as for adults.
 Tfal bejn 12 u 16- il sena għandhom jingħataw dożi bħall- kbar.
Take your tablet at least one hour before, or one hour after a meal.
Ħu l- pillola tiegħek mill- anqas siegħa qabel, jew siegħa wara ikla.
Swallow the tablet whole with some water.
Ibla 'l- pillola sħiħa bi ftit ilma.
Continue taking VFEND until your doctor tells you to stop.
Kompli ħu VFEND sakemm it- tabib tiegħek jgħidlek biex tieqaf.
Do not stop treatment early because your infection may not be cured.
Twaqqafx il- kura kmieni għax l - infezzjoni tiegħek tista 'ma tkunx imfejqa.
Patients with a weakened immune system or those with difficult infections may require long term treatment to prevent the infection from returning.
Il- pazjenti li għandhom sistema immunitarja mdgħajfa jew dawk b' infezzjonijiet diffiċli jistgħu jkollhom bżonn kura fit- tul biex jiġi evitat li l- infezzjoni terġa 'titfaċċa.
If you take more VFEND than you should:
Jekk tuża VFEND aktar milli suppost:
If you take more tablets than prescribed (or if someone else takes your tablets) you must seek medical advice or go to the nearest hospital casualty department immediately.
Jekk tieħu pilloli aktar milli ordnat (jew jekk xi ħadd ieħor jieħu l- pilloli tiegħek) inti għandek tfittex parir mediku jew tmur fid- dipartiment ta 'l- emerġenz ta' l- eqreb sptar immedjatament.
Take your box of VFEND tablets with you.
Ħu miegħek il - kaxxa tal- pilloli VFEND tiegħek.
If you forget to take VFEND:
117 Jekk tinsa tieħu VFEND:
It is important to take your VFEND tablets regularly at the same time each day.
Huwa importanti li tieħu l- pilloli VFEND tiegħek regolarment fl- istess ħin kuljum.
If you forget to take one dose, take your next dose when it is due.
Jekk tinsa tieħu doża, ħu d- doża tiegħek li jmiss meta dovut.
If you stop taking VFEND:
Jekk tieqaf tieħu VFEND:
It has been shown that taking all doses at the appropriate times may greatly increase the effectiveness of your medicine.
Ġie ppruvat li t- teħid tad- dożi kollha fil- ħinijiet xierqa jista 'jżid l- effikaċja tal- mediċina tiegħek b' mod sinifikanti.
Therefore unless your doctor instructs you to stop treatment, it is important to keep taking VFEND correctly, as described above.
Għalhekk sakemm it- tabib tiegħek ma jordnalekx biex twaqqaf il- kura, huwa importanti li tkompli tiegħu VFEND sewwa, kif deskritt fuq.
When VFEND treatment is stopped by your doctor you should not experience any effects.
Meta l- kura b' VFEND tiġi mwaqqfa mit- tabib tiegħek inti m' għandek tesperjenza ebda effetti.
However if you were taking medicines containing ciclosporin or tacrolimus you must mention this to your doctor, as the dose will need to be adjusted.
Madankollu, jekk kont qiegħed/ qiegħda tieħu mediċini li fihom cyclosporin jew tacrolimus inti għandek tgħid b' dan lit- tabib tiegħek, billi d- doża tkun trid tiġi aġġustata.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Jekk ikollok xi mistoqsijiet oħra dwar l- użu ta 'dan il- prodott, staqsi lit- tabib jew spiżjar tiegħek.
Like all medicines, VFEND can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, VFEND jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
If any side effects occur, most are likely to be minor and temporary.
Jekk ikun hemm xi effetti sekondarji, il- biċċa l- kbira tagħhom aktarx li jkunu żgħar u temporanji.
However, some may be serious and need medical attention.
Madankollu, xi wħud jistgħu jkunu serji u jeħtieġu attenzjoni medika.
Very common side effects (occurring in at least 1 in 10 patients) are:
Effetti sekondarji komuni ħafna (iseħħu f' mill- anqas 1 f' 10 pazjenti) huma:
- Visual disturbances (change in vision)
- Disturbi viżwali (tibdil fil- vista)
- Nausea, vomiting, diarrhoea
- Dardir, rimettar, dijarea
- Headache
- Uġigħ ta 'ras
- Swelling of the extremities
- Nefħa ta 'l- estremitajiet
- Stomach pains.
- Uġigħ fl- istonku.
Common side effects (occurring in at least 1 in 100 patients) are:
Effetti sekondarji komuni (iseħħu f' mill- anqas 1 f' 100 pazjent) huma:
- Flu-like symptoms, sinusitis, chills, weakness
- Sintomi bħall- influwenza, sinożite, kesħa, indeboliment
- Anaemia, low numbers of cells called platelets that help the blood to clot, low numbers of
- Anemija, ammonti baxxi ta 'ċelloli tad- demm imsejħa pjastrini li jgħinu lid- demm biex jagħqad,
some types of white blood cells or of all types of blood cells, red or purple discoloration of the skin which may be caused by low platelet count, other blood cell changes
ammonti baxxi ta 'ċerti tipi ta' ċelloli bojod tad- demm jew ta 'kull tip ta' ċelloli tad- demm, tbajja 'ħomor jew vjola tal- ġilda li jistgħu jkunu kkawżati minn għadd baxx ta' pjastrini, bidliet oħra fiċ- ċelloli tad- demm
- Anxiety, depression, tingling, confusion, dizziness, agitation, trembling, hallucinations and
- Ansjetà, depressjoni, tnemnim, konfużjoni, sturdament, aġitazzjoni, alluċinazzjonijiet bir- rogħda
other nervous symptoms
u sintomi oħra nervużi
- Low blood pressure, inflammation of a vein (which may be associated with the formation of
- Problemi fir- ritmu tal- qalb fosthom taħbit tal- qalb mgħaġġel, taħbit tal- qalb bil- mod ħafna, ħass
a blood clot)
ħażin