natgillin/translations-raw huggingface dataset:
However, the risk with IONSYS is low, as the medicine is for short-term use.
Ennek ellenére, mivel a gyógyszert rövid ideig szokták alkalmazni, a kockázat alacsony.
When in pain, the patient uses a button on the IONSYS system to start the delivery of a dose of fentanyl (40 micrograms).
Amikor a beteg fájdalmat érez, az IONSYS rendszeren lévő gomb megnyomásával egy adag fentanilt juttat a szervezetébe (40 mikrogramm).
IONSYS is an iontophoretic transdermal system (ITS), which delivers the active substance, fentanyl hydrochloride, into the body through the skin.
Az IONSYS egy olyan tapaszjellegű iontoforetikus transzdermális rendszer (ITS), amely a hatóanyagot, a fentanil-hidrokloridot a bőrön keresztül juttatja be a szervezetbe.
What benefit has IONSYS shown during the studies?
Milyen előnyei voltak az IONSYS alkalmazásának a vizsgálatok során?
The system will stop working 24 hours after the first dose or after 80 doses have been delivered.
Az IONSYS rendszer működése az első adag alkalmazását követő 24 óra múlva, illetve 80 adag kibocsátása után leáll.
The most common side effects with IONSYS (seen in more than 1 patient in 10) are nausea (feeling sick), vomiting, headache and erythema (redness of the skin) at the site of application.
A vizsgálatok során leggyakrabban (10 betegből egynél többször) megfigyelt mellékhatások a rosszullét, hányás, fejfájás és az alkalmazás helyén kialakuló erythema (bőrpír) voltak.
When the patient activates IONSYS, a small electrical current moves a dose of fentanyl from the reservoir through the skin and into the bloodstream.
Amikor a beteg aktiválja az IONSYS-t, - elektromos áram hatására - adott dózisú fentanil kerül a hatóanyag-tartályból a bőrön keresztül a véráramba.
Why has IONSYS been approved?
Miért engedélyezték az IONSYS-t?
IONSYS is given to the patient after an operation.
Az IONSYS-t műtét után kapja a meg a beteg.
Once in the bloodstream, fentanyl acts on receptors in the brain and spinal cord to prevent pain.
A véráramba kerülve a fentanil az agyi és a gerinvelői receptorokra hat, így csökkenti a fájdalmat.
For the full list of all side effects reported with IONSYS, see the Package Leaflet.
Az IONSYS használatához kapcsolódó összes mellékhatást illetően, lásd a betegtájékoztatót!
The Committee for Medicinal Products for Human Use (CHMP) concluded that IONSYS offers potential benefits compared to systems where the pain relief is given via a vein: it is non-invasive, needle-free and pre-programmed, and it can be activated by the patient.
Az európai nyilvános értékelő jelentés (CHMP) úgy döntött, hogy az IONSYS alkalmazásának lehetséges kedvező hatásai előnyösebbek a vénás fájdalomcsillapító módszereknél, mivel: a rendszer alkalmazása során az eszköz nem hatol a szervezetbe, nincs tűhasználat, előre programozható és a beteg saját maga adagolhatja.
These results show that IONSYS has a benefit in controlling pain after an operation.
Az eredmények azt mutatták, hogy az IONSYS hatása előnyős a műtéten átesett betegek fájdalmának csillapításában.
How does IONSYS work?
Hogyan működik az IONSYS?
IONSYS contain the active ingredient fentanyl, which is a strong painkiller.
Az IONSYS aktív hatóanyaga a fentanil, amely erős fájdalomcsillapító hatású.
What is the risk associated with IONSYS?
Milyen kockázatokkal jár az IONSYS alkalmazása?
Therefore, the Committee decided that IONSYS's benefits are greater than its risks for the management of acute moderate to severe post-operative pain for use in a hospital setting only.
Mindezek alapján a CHMP úgy ítélte meg, hogy az IONSYS kockázat/haszon profilja kedvező az akut mérsékelt, műtét utáni fájdalom kizárólag korházi körülmények között történő csillapításában, és ezért javasolta a forgalomba hozatali engedély kiadását.
How has IONSYS been studied?
Hogyan vizsgálták meg az IONSYS-t?
How is IONSYS used?
Hogyan kell alkalmazni az IONSYS-t?
Fentanyl, the active substance in IONSYS, can be abused.
Az IONSYS aktív hatóanyaga, a fentanil túladagolható.
The fentanyl is contained inside a reservoir.
Az IONSYS aktív hatóanyaga (fentanil) egy tartályban található az eszközön belül.
IONSYS is used to control pain after an operation, in patients who are in hospital.
Milyen betegségek esetén alkalmazható az IONSYS? Az IONSYS fekvőbeteg-gyógyintézetben, műtét utáni fájdalom csillapítására alkalmazható.
What is IONSYS?
Milyen típusú gyógyszer az IONSYS?
For the full list of restrictions, see the Package Leaflet.
Az IONSYS használatához kapcsolódó összes korlátozást illetően, lásd a betegtájékoztatót!
1 bottle + 1 syringe + 1 bottle adapter
1 palack fecskendő + 1 adapter a palackhoz
Oral solution Oral use
Szájon át történő alkalmazás
It may harm them, even if their signs of illness are the same as yours.
Għadu mhux magħruf l-effett ta' voriconazole fuq erythromycin jew azithromycin.
Incompatibilities:
Inkompatibilitajiet:
Località Marino del Tronto 63100 Ascoli Piceno (AP) Italy
Località Marino del Tronto 63100 Ascoli Piceno (AP) L-Italja
Adults
Adulti
6.2 Incompatibilities
6.2 Inkompatibilitajiet
Manufacturer Fareva Amboise, Zone Industrielle, 29 route des Industries, 37530 Pocé-sur-Cisse, France.
Manifattur Fareva Amboise, Zone Industrielle, 29 route des Industries, 37530 Pocé-sur-Cisse, Franza.
System Organ Class
Sistema talklassifika talorgani
Common to < 1/10
Komuni sa < 1/10
See section 4.4.
Ara sezzjoni 4.4.
Contains lactose monohydrate.
Fih lactose monohydrate.
Macrolide antibiotics
Antibijotiċi macrolide
INFORMATION IN BRAILLE
INFORMAZZJONI BIL-BRAILLE
4.3 Contraindications
4.3 Kontra-indikazzjonijiet
• Phototoxicity
• Fototossiċità
17.UNIQUE IDENTIFIER - 2D BARCODE
17. IDENTIFIKATUR UNIKU - BARCODE 2D
Anticoagulants
Antikoagulanti
Distribution
Distribuzzjoni
Date of first authorisation: 19 March 2002 Date of latest renewal: 21 February 2012
Data ta' l-ewwel awtorizzazzjoni: 19 ta' Marzu 2002 Data ta' l-aħħar tiġdid: 21 ta' Frar 2012
Rare ≥ 1/10,000 to <
Rari ≥ 1/10,000 sa <
3 years.
3 snin.
Dosage adjustment (Adults)
Aġġustament tad-doża (Adulti)
• Existing symptomatic arrhythmias.
• Arritmiji sintomatiċi eżistenti.
Tablets
Pilloli
Pfizer Europe MA EEIG Boulevard de la Plaine 17 1050 Bruxelles Belgium
Pfizer Europe MA EEIG Boulevard de la Plaine 17 1050 Bruxelles Il-Belġju
Summary of safety profile
Sommarju tal-profil tas-sigurtà
Powder for oral suspension 45 g
Trab għal suspensjoni orali 45g
See section 4.
Ara sezzjoni 4.
R-methadone (active) Cmax  31% R-methadone (active) AUC  47% S-methadone Cmax  65% S-methadone AUC  103%
R-methadone (attiv) Cmax  31% R-methadone (attiv) AUC  47% S-methadone Cmax  65% S-methadone AUC  103%
Interaction table
Tabella tal-Interazzjonijiet
EUCAST Breakpoints
Breakpoints tal-EUCAST
Treatment
Trattament
• invasive aspergillosis (a type of fungal infection due to Aspergillus sp),
• aspergillosis invażiva (tip ta' infezzjoni fungali b'Aspergillus sp),
Possible side effects
Effetti sekondarji possibbli
Non-Steroidal AntiInflammatory Drugs (NSAIDs) [CYP2C9 substrates]
Mediċini anti-infjammatorji non-sterojdali (NSAIDs) [sustratti ta' CYP2C9]
• St. John's Wort (herbal supplement)
• St. John's Wort (fexfiex) (suppliment erbali)
Difference in proportions and the 95% confidence interval (CI)
Differenza fil-proporzjonijiet u l-intervall ta' kunfidenza ta' 95% (CI)
Not studied clinically.
Mhux studjat klinikament.
Voriconazole is a triazole antifungal agent.
Voriconazole huwa aġent antifungali tat-tip triazole.
VFEND suspension contains 0.54g sucrose per ml of suspension.
Is-suspensjoni VFEND fiha 0.54 g sucrose għal kull ml ta' suspensjoni.
P-Value
Valur P
Pharmacotherapeutic group: Antimycotics for systemic use, triazole derivatives, ATC code: J02A C03
Grupp farmakoterapewtiku: Antimikosiċi għal użu sistemiku, derivattivi tat-triazole, Kodiċi ATC: J02A C03
Insufficient evidence
Evidenza insuffiċjenti
2D barcode carrying the unique identifier included.
barcode 2D li jkollu l-identifikatur uniku inkluż.
Sodium Chloride 9 mg/ml (0.9%) Solution for Injection Compound Sodium Lactate Intravenous Infusion 5% Glucose and Lactated Ringer's Intravenous Infusion 5% Glucose and 0.45% Sodium Chloride Intravenous Infusion 5% Glucose Intravenous Infusion 5% Glucose in 20 mEq Potassium Chloride Intravenous Infusion 0.45% Sodium Chloride Intravenous Infusion 5% Glucose and 0.9% Sodium Chloride Intravenous Infusion
Sodium Chloride 9 mg/ml (0.9%) Soluzzjoni għal Injezzjoni Kompożizzjoni ta' Infuzjoni ta' Sodium Lactate għal-gol-vina 5% Glucose u Lactated Ringer's Intravenous Infusion 5% Glucose u 0.45% Infużjoni Ġol-Vini ta' Sodium Chloride 5% Infużjoni Ġol-Vini ta' Glucose 5% Glucose fi 20 mEq ta' Infużjoni Ġol-Vini ta' Potassium Chloride 0.45% Infużjoni Ġol-Vini ta' Sodium Chloride 5% Glucose u 0.9% Infużjoni Ġol-Vini ta' Sodium Chloride
Powder for solution for infusion and powder for oral suspension: Fareva Amboise
Trab għal soluzzjoni għall-infużjoni u trab għal suspensjoni orali: Fareva Amboise
Digoxin (0.25 mg QD) [P-gp substrate]
Digoxin (0.25 mg QD) [sustratt ta' P-gp]
Uncommon ≥ 1/1,000 to <
Mhux komuni ≥ 1/1,000 sa <
ANNEX I
ANNESS I
Silica Colloidal Anhydrous Titanium Dioxide (E171) Xanthan Gum Sodium Citrate Citric Acid Anhydrous Sodium Benzoate (E211) Natural Orange Flavour
Silica, Colloidal Anhydrous Titanium Dioxide (E171) Xanthan Gum Sodium Citrate Citric Acid Anhydrous Sodium Benzoate (E211) Togħma ta' Larinġ Naturali
• The active substance is voriconazole.
• Is-sustanza attiva hi voriconazole.
Clinical efficacy and safety
Effikaċja klinika u sigurtà
Absorption
Assorbiment
4.6 Fertility, pregnancy and lactation
4.6 Fertilità, tqala u treddigħ
Astemizole, cisapride, pimozide, quinidine and terfenadine [CYP3A4 substrates]
Astemizole, cisapride, pimozide, quinidine u terfenadine [sustratti ta' CYP3A]
VFEND 200 mg film-coated tablets Each tablet contains 253.675 mg lactose monohydrate.
VFEND 200 mg pilloli miksijin b'rita Kull pillola fiha 253.675 mg lactose monohydrate.
General pharmacokinetic characteristics
Karatteristiċi farmakokinetiċi ġenerali
Marketing Authorisation Holder Pfizer Europe MA EEIG, Boulevard de la Plaine 17, 1050 Bruxelles, Belgium.
Id-detentur ta' l-awtorizzazzjoni għat-tqegħid fis-suq Pfizer Europe MA EEIG, Boulevard de la Plaine 17, 1050 Bruxelles, Il-Belġju.
• Non-steroidal anti-inflammatory drugs (e.g., ibuprofen, diclofenac) (used for treating pain and inflammation)
• Mediċini anti-infjammatorji non-sterojdali (e.ż., ibuprofen, diclofenac) (użati kontra l-uġigħ u infjammazzjoni)
Compared to voriconazole 200 mg BID,
Ikkumparat ma' voriconazole 200 mg BID,
See “Visual impairments” paragraph in section 4.8.
Ara l-paragrafu “Indebolimenti viżwali” fis-sezzjoni 4.8.
Benzodiazepines (e.g., midazolam, triazolam, alprazolam) [CYP3A4 substrates]
Benzodiazepines (e.ż., midazolam, triazolam, alprazolam) [sustratti ta' CYP3A4]
Phenytoin Cmax  67% Phenytoin AUC  81% Compared to voriconazole 200 mg BID,
Phenytoin Cmax  67% Phenytoin AUC  81% Ikkumparat ma' voriconazole 200 mg BID,
Includes akathisia and parkinsonism.
Tinkludi akatisja u parkinsoniżmu.
Ranitidine (150 mg BID) [increases gastric pH]
Ranitidine (150 mg BID) [jżid il-pH gastriku]
Rifampicin (600 mg QD) [potent CYP450 inducer]
Rifampicin (600 mg QD) [induttur qawwi ta' CYP450]
In an independent published study, Oxycodone Cmax  1.7-fold Oxycodone AUC0-  3.6-fold
Fi studju indipendenti ppublikat, Oxycodone Cmax  1.7 darbiet Oxycodone AUC0-  3.6 darbiet
There is limited data on the safety of VFEND in patients with abnormal liver function tests (aspartate transaminase [AST], alanine transaminase [ALT], alkaline phosphatase [ALP], or total bilirubin >5 times the upper limit of normal).
Hemm dejta limitata dwar is-sigurtà ta' VFEND f'pazjenti b'testijiet tal-funzjoni tal-fwied mhux normali (aspartate transaminase [AST], alanine transaminase [ALT], alkaline phosphatase [ALP], jew bilirubin totali >5 darbiet il-limitu ta' fuq tan-normal).
Fusarium spp.
prolificans u Fusarium spp.
• Fluconazole (used for fungal infections)
• Fluconazole (użat għal infezzjonijiet fungali)
Film-coating Hypromellose Titanium dioxide (E171) Lactose monohydrate Glycerol triacetate
Kisja tar-rita Hypromellose Titanium dioxide (E171) Lactose monohydrate Glycerol triacetate
Step 5
Punt 5
Voriconazole Cmax and AUC ↔
Voriconazole Cmax u AUC ↔
Methadone (32-100 mg QD) [CYP3A4 substrate]
Methadone (32-100 mg QD) [sustratt ta' CYP3A4]
Erythromycin (1 g BID) [CYP3A4 inhibitor]
Erythromycin (1 g BID) [inibitur ta' CYP3A4]
Contraindicated (see section
Kontraindikat (ara sezzjoni
QUALITATIVE AND QUANTITATIVE COMPOSITION
GĦAMLA KWALITATTIVA U KWANTITATTIVA
Prophylaxis
Profilassi
Multiple intravenous doses of 3, 4, 6, 7 and 8 mg/kg twice daily and multiple oral doses (using the powder for oral suspension) of 4 mg/kg, 6 mg/kg, and 200 mg twice daily were evaluated in 3 paediatric pharmacokinetic studies.
.Dożi multipli filvina ta' 3, 4, 6, 7 u 8 mg/kg darbtejn kuljum u dożi multipli orali (bl-użu tat-trab għas-suspensjoni orali) ta' 4 mg/kg, 6 mg/kg, u 200 mg darbtejn kuljum kienu evalwati fi 3 studji farmakokinetiċi f'pazjenti tfal.
A single adverse reaction of photophobia of 10 minutes duration was reported.
Kienet irrapportata reazzjoni avversa waħda ta' fotofobija li damet 10 minuti.
Sulfonylureas (e.g., tolbutamide, glipizide, glyburide) [CYP2C9 substrates]
Sulfonylureas (e.ż., tolbutamide, glipizide, glyburide) [sustratti ta' CYP2C9]
Hypersensitivity
Sensittività eċċessiva
Statins (e.g., lovastatin) [CYP3A4 substrates]
Statins (e.ż., lovastatin) [sustratti ta' CYP3A4]
4.9 Overdose
4.9 Doża eċċessiva
The survival rate at Day 180 was 80.0% (32/40) and at 1 year was 70.0% (28/40).
Ir-rata ta' sopravivenza f'Jum 180 kienet ta' 80.0% (32/40) u massena kienet ta' 70.0% (28/40).
St. John's Wort [CYP450 inducer; Pgp inducer] 300 mg TID (coadministered with voriconazole 400 mg single dose)
St John's Wort (fexfiex) [induttur ta' CYP450; induttur ta' P-gp] 300 mg TID (mogħti flimkien ma' doża waħda ta' 400 mg voriconazole)
The overall rate of response (ICC and EC combined) was 88.9% (8/9) for 2 to <12 years old and 62.5% (5/8) for 12 to <18 years old.
Ir-rata ta' rispons globali (ICC u EC flimkien) kienet 88.9% (8/9) għal pazjenti li kellhom minn sentejn sa <12-il sena u 62.5% (5/8) għal pazjenti li kellhom minn 12 sa <18-il sena.
Mycophenolic acid Cmax ↔ Mycophenolic acid AUCt ↔
Aċidu mikofenoliku Cmax ↔ Aċidu mikofenoliku AUCt ↔
• Statins (e.g., atorvastatin, simvastatin) (used for lowering cholesterol)
• Statins (e.ż., atorvastatin, simvastatin) (użati biex ibaxxu l-kolesterol)
LIST OF EXCIPIENTS
LISTA TA' EĊĊIPJENTI
Oxycodone (10 mg single dose)
Oxycodone (doża waħda ta' 10 mg)
The placeboadjusted mean maximum increases in QTc from baseline after 800, 1200 and 1600 mg of voriconazole were 5.1, 4.8, and 8.2 msec, respectively and 7.0 msec for ketoconazole 800 mg. No subject in any group had an increase in QTc of ≥ 60 msec from baseline.
Iż-żidiet massimi medji aġġustati bil-plaċebo fil-QTc mil-linja bażika wara 800, 1200 u 1600 mg ta' voriconazole kienu 5.1, 4.8, u 8.2 msec, rispettivament u 7.0 msec għal ketoconazole 800 mg.
• Astemizole (used for allergy)
• Astemizole (użat għal allerġija)
VFEND must not be infused into the same line or cannula concomitantly with other drug infusions, including parenteral nutrition (e.g., Aminofusin 10% Plus).
VFEND ma għandux jiġi infuż fl-istess linja jew kannula fl-istess ħin ma' infużjonjiet ta' prodotti mediċinali oħra, inkluż nutriment parenterali (eż Aminofusin 10% Plus).
• Ergot alkaloids (e.g., ergotamine, dihydroergotamine; used for migraine)
• Alkalojdi ta' l-ergotina (e.ż., ergotamine, dihydroergotamine; użati għall-emigranja)
including A. flavus, A. fumigatus, A. terreus, A. niger, A. nidulans; Candida spp., including C. albicans, C. glabrata, C. krusei, C. parapsilosis and C. tropicalis; and limited numbers of C. dubliniensis, C. inconspicua, and C. guilliermondii, Scedosporium spp., including S. apiospermum, S. prolificans; and Fusarium spp.
fumigatus, A. terreus, A. niger, A. nidulans, Candida spp; fosthom C. albicans, C. glabrata, C. krusei, C. parapsilosis u C. Tropicalis; u ammonti limitati ta' C. dubliniensis, C. inconspicua, u C. guilliermondii, Scedosporium spp., fosthom S. apiospermum, S. prolificans u Fusarium spp.
Frequency categories are expressed as: 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).
Il-kategoriji tal-frekwenzi huma ppreżentati bħala: Komuni ħafna (≥1/10; Komuni (≥1/100 u <1/10); Mhux komuni (≥1/1,000 u <1/100); Rari (≥1/10,000 u <1/1,000); Rari ħafna (<1/10,000); Mhux magħruf (ma setgħetx tittieħed stima mid-dejta disponnibli).
Mycophenolic acid (1 g single dose) [UDP-glucuronyl transferase substrate]
Aċidu mikofenoliku (doża waħda ta' 1 g) [sustratt ta' UDP-glucuronyl transferas]
Pharmacokinetic/pharmacodynamic Relationship
Relazzjonijiet farmakokinetiċi/farmakodinamiċi
Powder for oral suspension
Suspensjoni orali
In an independent published study, Voriconazole AUC0-  59%
Fi studju indipendenti ppublikat, Voriconazole AUC0-  59%
Content of the pack and other information
Kontenut tal-pakkett u informazzjoni oħra
The asterisk (*) indicates a twoway interaction.
L-asterisk (*) jindika interazzjoni miż-żewġ naħat.
Fentanyl (5 g/kg single dose)
Fentanyl (doża waħda ta' 5 g/kg)
Reporting of side effects
Rappurtar tal-effetti sekondarji
Oral
Orali
In an independent published study, Sirolimus Cmax  6.6-fold Sirolimus AUC0-  11-fold
Fi studju indipendenti ppublikat, Sirolimus Cmax  6.6 darbiet Sirolimus AUC0-  11 il-darba
Other Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTIs) (e.g., delavirdine, nevirapine) [CYP3A4 substrates, inhibitors or CYP450 inducers]
Inibituri oħra tan-NonNucleoside Reverse Transcriptase Inhibitors (NNRTIs) (e.ż., delavirdine, nevirapine) [sustratti ta' CYP3A4, inibituri jew indutturi ta' CYP450]
Efavirenz (a non-nucleoside reverse transcriptase inhibitor) [CYP450 inducer; CYP3A4 inhibitor and substrate]
Efavirenz (inibittur tan-nonnucleoside reverse transcriptase) [induttur ta' CYP450; inibitur u sustratt ta' CYP3A4]
• Rifabutin (used for treating tuberculosis).
• Rifabutin (użat għall-kura tat-tuberkulosi).
Overall, the safety profile of voriconazole in paediatric population was similar to that in adults.
Globalment, il-profil tas-sigurtà ta' voriconazole fil-popolazzjoni pedjatrika kien simili għal dak fl-adulti.
• Non-nucleoside reverse transcriptase inhibitors (e.g., efavirenz, delavirdine, nevirapine) (used for treating HIV) (some doses of efavirenz can NOT be taken at the same time as VFEND)
• Non-nucleoside reverse transcriptase inhibitors (e.ż., efavirenz, delavirdine, nevirapine) (użati għall-kura ta' l-HIV) (ċerti dożi ta' efavirenz MHUX suppost jittieħdu fl-istess ħin ma voriconazole)
Studies in animals have shown reproductive toxicity (see section 5.3).
Studji fl-annimali wrew tossiċità riproduttiva (ara sezzjoni 5.3).
MIC breakpoint (mg/L) ≤S (Susceptible) >R (Resistant)
MIC breakpoint (mg/L)
- The other ingredients are sucrose; silica colloidal; titanium dioxide; xanthan gum; sodium citrate; sodium benzoate; citric acid; natural orange flavour.
• Is-sustanzi l-oħra huma sucrose; silica, colloidal ; titanium dioxide; xanthan gum; sodium citrate; sodium benzoate; aċidu ċitriku; togħma naturali tal-larinġ.
6 weeks after EOT
6 ġimgħat wara EOT
High dose (400 mg BID)
Doża għolja (400 mg BID)
squamous cell carcinoma*
karċinoma fiċ-ċelluli skwamużi*
Low dose (100 mg BID)
Doża baxxa (100 mg BID)
• serious fungal infections caused by Scedosporium sp. or Fusarium sp. (two different species of fungi).
• infezzjonijiet fungali serji kkawżati minn Scedosporium spp. u Fusarium spp. (żewġ speċi differenti ta' fungus).
The potential risk for humans is unknown.
Ir-riskju potenzjali għan-nies mhux magħruf.
• serious invasive Candida sp. infections when the fungus is resistant to fluconazole (another antifungal medicine),
• infezzjonijiet invażivi serji ta' Candida sp. fejn il-fungus huwa reżistenti għal fluconazole (mediċina antifungali oħra),
• Terfenadine (used for allergy)
• Terfenadine (użat għal allerġija)
In 10 therapeutic studies, the median for the average and maximum plasma concentrations in individual subjects across the studies was 2425 ng/ml (inter-quartile range 1193 to 4380 ng/ml) and 3742 ng/ml (interquartile range 2027 to 6302 ng/ml), respectively.
F'10 studji terapewtiċi, il-punt medjan għal konċentrazzjonijiet medji u massimi fil-plasma f'suġġetti individwali madwar l-istudji kien 2425 ng/ml (medda inter-quartile 1193 sa 4380 ng/ml) u 3742 ng/ml (medda inter-quartile 2027 sa 6302 ng/ml), rispettivament.
Alfentanil (20 μg/kg single dose, with concomitant naloxone)
Alfentanil (doża waħda ta' 20 μg/kg, flimkien ma' naloxone)
Note: Based on a population pharmacokinetic analysis in 112 immunocompromised paediatric patients aged 2 to <12 years and 26 immunocompromised adolescents aged 12 to <17 years.
Nota: Fuq bażi tal-analiżi farmakokinetika tal-popolazzjoni fi 112 pazjenti immunokompromessi tfal ta' bejn 2 u <12-il sena u 26 adoloxxenti immunokompromessi ta' bejn 12 u <17-il sena.
• Sulfonylureas (e.g., tolbutamide, glipizide, and glyburide) (used for diabetes)
• Sulfonylureas (e.ż., tolbutamide, glipizide, u glyburide) (użati għad-dijabete)
Store in a refrigerator (2°C - 8°C).
Aħżen fi friġġ (2°C - 8°C ) qabel rikostituzzjoni.
Step 4
Punt 4
Immunosuppressants [CYP3A4 substrates]
Immunosoppressanti [sustratti ta' CYP3A4]
Treatment of fluconazole-resistant serious invasive Candida infections (including C. krusei).
Kura ta' infezzjonijiet invażivi serji Candida reżistenti għal fluconazole (fosthom C. krusei).
Total parenteral nutrition: Total parenteral nutrition (TPN) need not be discontinued when prescribed with VFEND, but does need to be infused through a separate line.
Nutrizzjoni parenterali totali: In-nutrizzjoni parenterali totali (TPN) m'hemmx għalfejn tiġi mwaqqfa meta ordnata ma' VFEND, iżda trid tiġi infuża minn linja separata.
VFEND 50 mg film-coated tablets Each tablet contains 63.42 mg lactose monohydrate.
VFEND 50 mg pilloli miksijin b'rita Kull pillolla fiha 63.42 mg lactose monohydrate
Ergot alkaloids (e.g., ergotamine and dihydroergotamine) [CYP3A4 substrates]
Alkalojdi tal-ergotina (e.ż., ergotamine u dihydroergotamine) [sustratti ta' CYP3A4]
Vinca Alkaloids (e.g., vincristine and vinblastine) [CYP3A4 substrates]
Alkalojdi Vinca (e.ż., vincristine u vinblastine) [sustratti ta' CYP3A4]
The safety of voriconazole was investigated in 288 paediatric patients aged 2 to <12 years (169) and 12 to <18 years (119) who received voriconazole for prophylaxis (183) and therapeutic use (105) in clinical trials.
Is-sigurtà ta' voricoanzole ġiet studjata f'288 pazjenti tfal fl-etajiet ta' 2 sa <12-il sena (169) u 12 sa <18-il sena (119) li rċevew voriconazole għal profilassi (183) u għal użu terapewtiku (105) fil-provi kliniċi.
In an independent published study, Alfentanil AUC0-  6-fold
Fi studju indipendenti ppublikat, Alfentanil AUC0-  6 darbiet
Tacrolimus (0.1 mg/kg single dose)
Tacrolimus (doża waħda ta' 0.1 mg/kg)
In an independent published study, Fentanyl AUC0-  1.34-fold
Fi studju indipendenti ppublikat, Fentanyl AUC0-  1.34 darbiet
Ciclosporin (in stable renal transplant recipients receiving chronic ciclosporin therapy)
Ciclosporin (f'riċevituri stabbli ta' trapjant tal-kliewi li qed jirċievu terapija kronika b'ciclosporin)
Other medicines and VFEND
Mediċini oħra u VFEND
Phenytoin (CYP2C9 substrate and potent CYP450 inducer) Careful monitoring of phenytoin levels is recommended when phenytoin is coadministered with voriconazole.
Phenytoin (sustratt ta' CYP2C9 u induttur qawwi ta' CYP450) Huwa rakkomandat monitoraġġ attent tal-livelli ta' phenytoin meta phenytoin jiġi amministrat flimkien ma' voriconazole.
Step 2
Punt 2
Serious dermatological adverse reactions
Reazzjonijiet avversi dermatoloġiċi serji
R-Pharm Germany GmbH Heinrich-Mack-Str. 35, 89257 Illertissen Germany
35, 89257 Illertissen Il-Ġermanja
Voriconazole is haemodialysed with a clearance of 121 ml/min.
Voriconazole jiġi ħemodijalizzat bi tneħħija ta' 121 ml/min.
Step 7
Punt 7
Phenytoin [CYP2C9 substrate and potent CYP450 inducer]
Phenytoin [sustratt ta' CYP2C9 u induttur qawwi ta' CYP450]