natgillin/translations-raw huggingface dataset:
5 micrograms
iloprosta pri ustniku 2, 5 mikrogramov 5 mikrogramov
6.5 min
inhalacijski čas 3, 2 min 6, 5 min
For further details please refer to the instruction manual of the nebuliser device or ask your doctor.
Za podrobnosti glejte navodilo za uporabo nebulatorja Venta- neb ali se posvetujte z zdravnikom.
Ask your doctor to have someone help you become thoroughly familiar with the use of the nebuliser.
32 Prosite zdravnika da vam nekdo pomaga, dokler popolnoma ne osvojite uporabe nebulatorja.
You should not switch to another nebuliser without consulting your treating doctor.
Nebulatorja ne smete zamenjati z drugim, ne da bi se pred tem posvetovali s svojim zdravnikom.
Caution:
Opozorilo
Do not let Ventavis solution come into contact with your skin or eyes.
Pazite, da inhalacijska raztopina zdravila Ventavis ne pride v stik s kožo ali očmi.
If it does, rinse the skin or your eyes immediately with water.
Če se to vseeno zgodi, kožo ali oči takoj sperite z vodo.
Do not drink Ventavis solution.
Ne pijte raztopine zdravila Ventavis!
If drinking accidentally occurs, drink plenty of water and talk to a doctor.
Če bi jo po nesreči vseeno popili, spijte večjo količino vode in se posvetujte z zdravnikom.
Drinking Ventavis could also lead to a temporary overdose – see “ If you take more Ventavis than you should”.
Zaužitje zdravila Ventavis lahko tudi privede do prehodnih učinkov prevelikega odmerka – glejte » Če ste uporabili večji odmerek zdravila Ventavis kot bi smeli «
If you use more Ventavis than you should:
Če ste uporabili večji odmerek zdravila Ventavis kot bi smeli
Using more Ventavis than you should may lead to a decrease in blood pressure with symptoms like dizziness or fainting.
Če uporabite več zdravila Ventavis, kot bi smeli, lahko pride do hudega padca krvnega tlaka ter posledično vrtoglavice ali omedlevice.
You may also experience headache, reddening of the face (flushing), feeling sick (nausea), vomiting or diarrhoea.
Lahko se pojavijo tudi glavobol, rdečica obraza (pordelost), slabost (navzea), bruhanje ali driska.
If this happens: • Stop the inhalation session • Talk to your doctor
V tem primeru: prekinite z inhaliranjem posvetujte se s svojim zdravnikom.
See also section 2, Take special care with Ventavis, for advice on what you have to do if you have low blood pressure or fainting episodes.
Glejte tudi poglavje 2 » Bodite posebno pozorni pri uporabi zdravila Ventavis « glede navodil, kaj storiti, če imate nizek krvni tlak ali se vam pojavljajo omedlevice.
If you forget to take a dose:
Če ste pozabili vzeti odmerek zdravila Ventavis
You should not take a double dose to make up for a forgotten dose.
Ne vzemite dvojnega odmerka, če ste pozabili vzeti prejšnji odmerek.
Please ask your doctor what you should do.
Posvetujte se s svojim zdravnikom, kaj storiti.
If you stop taking Ventavis:
Če ste prenehali uporabljati zdravilo Ventavis
If you stop or wish to stop treatment, you should discuss this with your doctor first.
Če prenehate ali želite prenehati zdravljenje, se najprej posvetujte z zdravnikom.
Room ventilation:
Zračenje prostora
Other persons might accidentally be exposed to Ventavis through the room air.
Zaradi neustreznega zračenja lahko pride do naključne izpostavljenosti drugih oseb zdravilu Ventavis.
In particular, newborns, infants, and pregnant women should not be subjected to Ventavis.
Zlasti novorojenci, dojenčki in nosečnice ne smejo biti izpostavljeni zdravilu Ventavis.
Like all medicines, Ventavis can cause side effects, although not everybody gets them.
Kot vsa zdravila ima lahko tudi zdravilo Ventavis neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
Below we list possible side effects by how likely they are:
Spodaj navajamo možne neželene učinke po pogostnosti.
affects more than 1 user in 10.
pojavijo se pri več kot enem od 10 bolnikov pojavijo se pri 1 do 10 bolnikov od 100
Common: affects 1 to 10 users in 100.
• Zelo pogosti
• Very common side effects
neželeni učinki
- Widening of the blood vessels (vasodilatation).
- razširjene krvne žile (vazodilatacija).
Symptoms can be flushing or reddening of the face.
Simptoma sta lahko pordelost ali zardevanje v obraz.
- Increase in coughing
- močnejši kašelj
- Low blood pressure (hypotension).
- nizek krvni tlak (hipotenzija)
Peripheral oedema is a very common symptom of the illness itself but can also occur during treatment with Ventavis.
Periferni edem je zelo pogost simptom same bolezni, lahko pa se pojavi tudi med zdravljenjem z zdravilom Ventavis.
• Common effects
33 • Pogosti neželeni učinki
- Headaches.
- glavobol
- Pain in jaw/ spasm of the jaw muscles (trismus)
- bolečina v čeljusti/ krč čeljustnih mišic (trizmus)
- Dizziness, which is related to low blood pressure (hypotension).
- omotica, ki je povezana z nizkim krvnim tlakom (hipotenzijo)
- Fainting (syncope)
- omedlevica (sinkopa)
Fainting (syncope) is a common symptom of the illness itself but can also occur during treatment with Ventavis.
Omedlevica (sinkopa) je pogost simptom same bolezni, lahko pa se pojavi tudi med zdravljenjem z zdravilom Ventavis.
See also section 2, Take special care with Ventavis, for advice on what you can do to try and avoid this.
Glejte tudi poglavje 2 » Bodite posebno pozorni pri uporabi zdravila Ventavis « glede navodil, kaj storiti, da bi to preprečili.
• Other possible effects
• Drugi možni učinki
If you are also taking blood-thinning medicines (anticoagulants), minor bleeding events are likely to occur commonly.
Če jemljete tudi zdravila proti strjevanju krvi (antikoagulante), se lahko pogosto pojavijo manjše krvavitve.
In this case ask your doctor.
V tem primeru se posvetujte z zdravnikom.
Vomiting, nausea, diarrhoea and dyspnoea have been reported in patients using Ventavis.
Pri bolnikih, ki so uporabljali zdravilo Ventavis so poročali o bruhanju, navzei, driski in dispneji.
Breathing difficulties and wheezing have been reported after Ventavis use, particularly in patients with an infection of the lungs, severe asthma, or other lung disease.
Posebno pri bolnikih z okužbo pljuč, hudo astmo ali pljučnimi boleznimi, so pri uporabi zdravila Ventavis poročali o težavah z dihanjem in sopenju.
• Adverse events in healthy volunteers
• Neželeni učinki pri zdravih prostovoljcih
Pain, discomfort in the breast (32.5%), pain when swallowing (pharyngolaryngeal pain, throat irritation (22.5%)) and nausea (7.5%) were adverse events that occurred in healthy volunteers in a special study, when they received fixed 2.5 microgram 6 times daily.
Bolečina, neugodje v prsih (32, 5%), bolečina pri požiranju (bolečine v žrelu in grlu ali draženje grla (22, 5%)) in navzea (7, 5%) so bili neželeni učinki, ki so se pojavljali pri zdravih prostovoljcih v posebni študiji v kateri so dobivali 2, 5 mikrogamske odmerke 6 - krat dnevno.
All these adverse events were non-serious and mild.
Vsi ti učinki so bili blagi.
o If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, tell your doctor or pharmacist.
Če katerikoli neželeni učinek postane resen ali če opazite katerikoli neželeni učinek, ki ni omenjen v tem navodilu, obvestite svojega zdravnika ali farmacevta.
HOW TO STORE VENTAVIS
SHRANJEVANJE ZDRAVILA VENTAVIS
Do not use Ventavis after the expiry date which is stated on the pack.
Zdravila Ventavis ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na ovojnini.
There are no special storage instructions.
Posebna navodila za shranjevanje niso potrebna.
34 Medicines should not be disposed of via wastewater or household waste.
Zdravila ne smete odvreči v odpadne vode ali med gospodinjske odpadke.
What Ventavis contains: • The active substance is iloprost.
• Zdravilna učinkovina je iloprost.
• The other ingredients are trometamol, ethanol 96%, sodium chloride, hydrochloric acid for pH adjustment, and water for injections.
• Pomožne snovi so trometamol, etanol 96%, natrijev klorid, klorovodikova kislina za uravnavanje pH in voda za injekcije.
Ventavis is provided in colourless ampoules (type I glass), containing either 1 ml or 2 ml nebuliser solution.
34 Zdravilo Ventavis je na voljo v brezbarvnih ampulah (steklo vrste I), ki vsebujejo 1 ml ali 2 ml inhalacijske raztopine za nebulator.
Ventavis is a clear, colourless nebuliser solution for inhalation.
Zdravilo Ventavis je bistra, brezbarvna inhalacijska raztopina za nebulator.
Ventavis is available in packs containing:
Zdravilo Ventavis je na voljo v pakiranjih, ki vsebujejo:
- 30, 90, 100, or 300 ampoules with 2 ml for the use with HaloLite, Prodose and Venta-Neb.
- 30, 100 ali 300 ampul po 2 ml za uporabo z nebulatorji HaloLite, Prodose in Venta- Neb.
The
Ampule
ampoules containing 2 ml show two coloured rings (white – pink).
po 2 ml so označene dvema barvnima obročema (bel– rožnat);
- or 30 or 168 ampoules with 1 ml for use with the I-Neb nebuliser.
- ali 30 ali 168 ampul po 1 ml za uporabo z nebulatorjem I- Neb.
The ampoules containing 1 ml
Ampule po 1 ml so označene s
show three coloured rings (pink – red- red).
tremi barvnimi obroči (rožnat– rdeč– rdeč).
Bayer Schering Pharma AG, D-13342 Berlin, Germany
Imetnik dovoljenja za promet z zdravilom Bayer Schering Pharma AG, D – 13342 Berlin, Nemčija
Manufacturer:
Izdelovalec Berlimed.
Berlimed S. A., Poligono Industrial Santa Rosa s/ n, 28806 Alcalá de Henares, Madrid, Spain
S. A., Poligono Industrial Santa Rosa s/ n, 28806 Alcalá de Henares, Madrid, Španija
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
35 Za vse morebitne nadaljnje informacije o tem zdravilu se lahko obrnete na predstavništvo imetnika dovoljenja za promet z zdravilom:
Alfred Gera and Sons Ltd.
Tél/ Tel: +32 - (0) 2- 535 63 11 Magyarország Bayer Hugária KFT Tel.: +36 1487- 4100 Malta Alfred Gera and Sons Ltd.
Deutschland Bayer Vital GmbH Tel: +49-(0)214-30 513 48
Danmark Bayer A/ S Tlf: +45- 45 235000 Deutschland Bayer Vital GmbH Tel: +49 - (0) 214- 30 513 48 Eesti UAB Bayer Eesti filiaal Tel: +372 655 8565 Ελλάδα Bayer Ελλάς ΑΒΕΕ Τηλ: +30 210 618 75 00
Norge Bayer AS Tlf: +47 24 11 18 00
Nederland Bayer B. V., Bayer Schering Pharma Tel: +31 - (0) 297- 28 06 66 Norge Bayer AS Tlf: +47 24 11 18 00 Österreich Bayer Austria Ges. m. b. H.
Tel: +43-(0)1-71146-0
Tel: +43 - (0) 1- 71146- 0 Polska Bayer Sp. z o. o.
Tel: +34-93-495 65 00
Sími: + 354 540 80 00 Italia Italfarmaco S. p. A.
Romania SC Bayer SRL Tel.: +40 21 528 59 00
Tel: +351 21 416 42 00 Romania SC Bayer SRL Tel.: +40 21 528 59 00 Slovenija Bayer d. o. o.
Tel: + 386 1 58 14 400
Tel: + 386 1 58 14 400 Slovenská republika Bayer spol. s r. o.
Suomi/ Finland Bayer Oy, Bayer Schering Pharma Puh/ Tel: +358-20-78521
Tel. +421 2- 59 21 31 11 Suomi/ Finland Bayer Oy, Bayer Schering Pharma Puh/ Tel: +358- 20- 78521 Sverige Bayer AB Tel: +46 - (0) 8 580 223 00 United Kingdom Bayer plc Tel: +44 - (0) 16 35- 56 30 00
Sverige Bayer AB Tel: +46-(0)8 580 223 00
Datum zadnje revizije navodil:
Lietuva UAB Bayer, Bayer Schering Pharma Tel. +37 05 23 36 868
Zdravilo je pridobilo tako imenovano "pogojno dovoljenje za promet".
This leaflet was last approved in
To pomeni, da se pričakujejo dodatni dokazi o zdravilu.
36 The European Medicines Agency (EMEA) will review any new information on the medicine every year and this leaflet will be updated as necessary.
36 Evropska agencija za zdravila (EMEA) bo vsako leto ponovno pregledala nove podatke o zdravilu in posodobila navodilo za uporabo, če bo potrebno.
For each inhalation session the content of one ampoule containing 2 ml of Ventavis nebuliser solution will be transferred into the nebuliser medication chamber immediately before use.
Za vsako inhalacijo se vsebina ene ampule z 2 ml Ventavis inhalacijske raztopine za nebulator neposredno pred uporabo prenese v prostor za zdravilo v nebulatorju.
The inhalation time depends on the patient’ s breathing pattern.
Trajanje inhalacije je odvisno od bolnikovega načina dihanja.
Device
pripomoček
Dose of iloprost at mouthpiece
Odmerek iloprosta pri ustniku
(frequency of 15 breaths per minute)
(frekvenca 15 vdihov na minuto)
For a dose of 5 micrograms iloprost at mouthpiece it is recommended to complete two inhalation cycles with 2.5 micrograms pre-set dose program with a filling of one ampoule containing 2 ml Ventavis nebuliser solution, which shows two coloured rings (white – pink).
Za odmerek 5 mikrogramov iloprosta pri ustniku je priporočljivo narediti dva inhalacijska cikla s predhodno določenim odmerkom 2, 5 mikrogramov in polnjenjem iz ene ampule po 2 ml Ventavis inhalacijske raztopine za nebulator, na kateri sta dva barvna obroča (bel– rožnat).
For details refer to the instruction manuals of the HaloLite and Prodose nebuliser.
Za podrobnosti glejte navodila za uporabo nebulatorjev HaloLite in Prodose.
VentaNeb, a portable ultrasonic battery-powered nebuliser, has also been shown to be suitable for the administration of Ventavis.
Prenosni, ultrazvočni, baterijski nebulator Venta- Neb je dokazano tudi primeren za apliciranje zdravila Ventavis.
For each inhalation session, the content of one ampoule containing 2 ml of Ventavis nebuliser solution and showing two coloured rings (white – pink) will be transferred into the nebuliser medication chamber immediately before use.
Za vsako inhalacijo se vsebina ene ampule z 2 ml Ventavis inhalacijske raztopine za nebulator neposredno pred inhalacijo prenese v prostor za zdravilo v nebulatorju.
The selection of the pre set program is made by the physician.
2, 5 mikrogramov zdravilne učinkovine na ustniku 10 inhalacijskih ciklov Zdravnik predhodno izbere določen program.
VentaNeb prompts the patient to inhale by an optical and an acoustic signal.
Nebulator Venta- Neb z optičnim in zvočnim signalom spodbudi bolnika naj vdihne.
Dose of iloprost at mouthpiece
Odmerek iloprosta pri ustniku 2, 5 mikrogramov
Estimated Inhalation time
Predviden inhalacijski čas 4 min
The I-Neb AAD System is a portable, hand-held, vibrating mesh technology nebuliser system, This system generates droplets by ultrasound, which is forcing the solution through a mesh.
Sistem z ultrazvokom potiska raztopino skozi mrežico in tako ustvarja kapljice.
37 This nebuliser monitors the breathing pattern to determine the aerosol pulse time required to deliver the pre-set dose of 2.5 or 5 micrograms iloprost.
Nebulator spremlja način dihanja in tako določi pulzni čas aerosola, potreben za dovajanje nastavljenega odmerka 2, 5 ali 5 mikrogramov iloprosta.
The pre-set dose provided by the I-Neb AAD system is controlled by the medication chamber and in combination with a control disc.
37 Prostor za zdravilo v kombinaciji z nadzornim diskom nadzira nastavljeni odmerek, ki ga dovaja nebulator I- Neb AAD.
For the 2.5 micrograms dose the medication chamber (350 microliter) with the red latch is used together with the red control disc.
Za odmerek 2, 5 mikrogramov se uporablja prostor (350 mikrolitrov) z rdečim zapahom in rdečim nadzornim diskom.
For the 5 micrograms dose the medication chamber (650 microliter) with the purple coloured latch is used together with the purple control disc.
Za odmerek 5 mikrogramov se uporablja prostor (650 mikrolitrov) z vijoličastim zapahom in vijoličastim nadzornim diskom.
2.5 micrograms 5 micrograms
iloprosta pri ustniku 2, 5 mikrogramov 5 mikrogramov
3.2 min 6.5 min
Predviden inhalacijski čas 3, 2 min 6, 5 min
Since the I-Neb nebuliser has been shown to produce an aerosol with slightly different physical characteristics to those of HaloLite, Prodose and VentaNeb devices and a faster delivery of the solution, patients stabilized on one nebuliser should not switch to another nebuliser without supervision by the treating physician.
Ker pri nebulatorju I- Neb nastane aerosol z nekoliko različnimi fizikalnimi lastnostmi v primerjavi z nebulatorji HaloLite, Prodose in VentaNeb in se raztopina hitreje sprosti, bolniki, pri katerih je stanje stabilno pri uporabi enega nebulatorja le- tega ne smejo zamenjati z drugim, ne da bi se pred tem posvetovali s svojim zdravnikom.
What is VFEND?
Kaj je zdravilo VFEND?
It is available as white tablets, which contain 50 mg or 200 mg of voriconazole, as an oral suspension, which contains 40 mg/ ml of voriconazole, and as a white powder to be made into a solution for infusion (drip into a vein).
Zdravilo VFEND je na voljo v obliki belih tablet, ki vsebujejo 50 mg ali 200 mg vorikonazola, ali kot peroralna suspenzija, ki vsebuje 40 mg/ ml vorikonazola, ali kot bel prašek, ki se pripravi v raztopino za infundiranje (dajanje tekočine v veno).
What is VFEND used for?
Za kaj se zdravilo VFEND uporablja?
VFEND is an antifungal medicine.
Zdravilo VFEND je sredstvo proti glivičnim okužbam.
It is used for the treatment of patients (adults and children over the age of 2) with: • invasive aspergillosis (a type of fungal infection due to Aspergillus sp), • candidaemia (another type of fungal infection due to Candida sp) in non-neutropenic patients (patients with a normal white blood cells count), • serious invasive Candida sp. infections when the fungus is resistant to fluconazole (another antifungal medicine), • serious fungal infections caused by Scedosporium sp. or Fusarium sp.
Uporablja pri bolnikih (odraslih in otrok, starejših od 2 let) za: • zdravljenje invazivne aspergiloze (glivične okužbe, ki jo povzroča Aspergillus spp.), • zdravljenje kandidemije (glivične okužbe, ki jo povzroča Candida spp.) pri nenevtropeničnih bolnikih (bolnikih z normalnimi ravnmi levkocitov v krvi), • zdravljenje hudih invazivnih, proti flukonazolu (drugemu zdravilu proti glivicam) odpornih okužb s Candido spp., • zdravljenje resnih glivičnih okužb, ki jih povzročajo Scedosporium spp. ali Fusarium spp.
(two different species of fungi).
(dve vrsti glivic).
VFEND is intended for patients with worsening, possibly life-threatening, fungal infections.
Zdravilo VFEND se uporablja pri bolnikih z glivično okužbo, pri katerih se okužba poslabšuje in je potencialno smrtno nevarna.
How is VFEND used?
Kako se zdravilo VFEND uporablja?
VFEND is given twice daily.
Zdravilo VFEND se daje dvakrat dnevno.
The dosage of VFEND to use depends on the weight of the patient and on the presentation used; for the full information, please see the Package Leaflet.
Odmerjanje zdravila VFEND je odvisno od telesne mase bolnika in uporabljene farmacevtske oblike.
Patients need to receive a loading dose on the first day of treatment.
Zdravljenje se začne s polnilnim odmerjanjem na prvi dan.
The aim of the loading dose is to reach ‘ steady state’ (stable) blood levels.
Namen začetnega odmerka je, da dosežemo „ ravnovesne “ (stabilne) ravni zdravila v krvi.
The loading dose is then followed by a maintenance dose that can be adjusted according to the patient’ s response.
Začetnemu odmerku sledi vzdrževalni odmerek, ki ga lahko prilagodimo glede na odziv bolnika.
There is no need of a loading dose in children aged between 2 and 12 years.
Pri otrocih, starih med 2 in 12 let, začetni odmerek ni potreben.
Both the loading and the maintenance dose can be given by infusion or orally, using either the tablets or the suspension, but the use of the suspension is recommended in children aged between 2 and 12 years.
Pri otrocih, starih med 2 in 12 let, je priporočena uporaba suspenzije.
The tablets and suspension are to be taken at least one hour before, or one hour following, a meal.
Tablete in suspenzijo je treba vzeti najmanj eno uro pred obrokom ali eno uro po obroku.
(44-20) 74 18 84 00 Fax (44-20) 74 18 84 16 E-mail: mail@emea. europa. eu http: / /www. emea. europa. eu ©EMEA 2006 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged cell membranes.
(44- 20) 74 18 84 00 Fax (44- 20) 74 18 84 16 E- mail: mail@ emea. europa. eu http: // www. emea. europa. eu ©EMEA 2006 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged Kako zdravilo VFEND deluje?
Without ergosterol, the fungus is killed or prevented from spreading.
Zdravilna učinkovina zdravila VFEND je vorikonazol, ki je zdravilo proti glivičnim okužbam iz skupine triazolov.
The list of fungi against which VFEND is active can be found in the Summary of Product Characteristics.
Seznam glivic, proti katerim zdravilo VFEND učinkuje, najdete v Povzetku glavnih značilnosti zdravila.
How has VFEND been studied?
Kako je bilo zdravilo VFEND raziskano?
The study of VFEND in invasive aspergillosis involved 277 immunocompromised patients (their immune system was not working properly).
V raziskavo uporabe zdravila VFEND pri invazivni aspergilozi je bilo vključenih 277 imunsko kompromitiranih bolnikov (njihov imunski sistem ni pravilno deloval).
VFEND was compared with amphotericin B (another antifungal medicine).
Zdravilo VFEND so primerjali z amfotericinom B (drugim zdravilom proti glivicam).
The study of VFEND in candidaemia (370 patients) compared VFEND with a treatment of amphotericin B followed by fluconazole.
V raziskavi uporabe zdravila VFEND pri kandidemiji (370 bolnikov) so primerjali zdravilo VFEND z zdravljenjem, kjer so najprej dajali amfotericin B, nato pa flukonazol.
VFEND has also been studied in serious refractory Candida infections (55 patients), in scedosporiosis (38 patients) and in fusariosis (21 patients).
Preučili so tudi uporabo zdravila VFEND za hude neodzivne okužbe s kandidami (55 bolnikov), skedosporiozo (38 bolnikov) in fuzaridiozo (21 bolnikov).
Most patients receiving VFEND treatment for these rare infections did not tolerate or did not respond to prior treatment with other antifungal therapy.
Večina bolnikov, ki so prejeli zdravilo VFEND za te redke okužbe, ni preneslo predhodnega zdravljenja z drugimi zdravili proti glivicam ali pa se niso odzvali nanj.
VFEND has also been studied in 61 children.
Zdravilo VFEND so preučevali tudi pri 61 otrocih.
The main measure of effectiveness in all studies was complete or partial response to treatment.
Glavni merili učinkovitosti v vseh raziskavah sta bila popoln oz. delni odziv na zdravljenje.
What benefit has VFEND shown during the studies?
Kakšne koristi je zdravilo VFEND izkazalo med raziskavami?
In invasive aspergillosis, the percentage of patients responding to treatment was higher with VFEND than with amphotericin B (53% versus 31%).
Pri invazivni aspergilozi je bil odstotek bolnikov, ki so se odzvali na zdravljenje, višji za zdravilo VFEND kot za amfotericin B (53% v primerjavi z 31%).
For candidaemia, the percentage of responders to VFEND treatment at the end of therapy was the same as for the comparator (72%).
Pri kandidemiji je bil na koncu zdravljenja odstotek bolnikov, ki so se odzvali na zdravilo, enak za zdravilo VFEND in za primerjano zdravilo.
A successful outcome was seen in 24/ 55 (43.6%) subjects with serious refractory Candida infections.
Pri hudih neodzivnih okužbah s kandidami je bil izid uspešen pri 24/ 55 (43, 6%) preiskovancih.
In most of these (15/ 24), the response was complete.
V večini primerov (15/ 24) je bil odziv popoln.
In the treatment of scedosporiosis and fusariosis, the overall response was 28/ 59 patients.
Pri zdravljenju skedosporioze in fuzaridioze je bil celokupen odziv opažen pri 25/ 59 bolnikih.
What is the risk associated with VFEND?
Kakšna tveganja so povezana z zdravilom VFEND?
The most commonly reported side effects are visual disturbances, fever, rash, nausea, vomiting, diarrhoea, headache, and swelling of the extremities.
Najpogostejši neželeni učinki so bili motnje vida, zvišana telesna temperatura, izpuščaj, slabost, bruhanje, driska, glavobol in otekanje okončin.
Stomach pains and changes in stools should be reported to a doctor.
Bolnik mora sporočiti zdravniku pojav bolečin v želodcu in spremembe blata.
For the full list of all side effects reported with VFEND, please see the Package Leaflet.
Celovit opis neželenih učinkov, o katerih so poročali pri uporabi zdravila VFEND, najdete v Navodilih za uporabo.
VFEND should not be used in people who may be hypersensitive (allergic) to voriconazole or any of the other ingredients.
Zdravila VFEND ne smejo uporabljati osebe, ki utegnejo biti preobčutljive za (alergične na) vorikonazol ali katerokoli drugo sestavino zdravila.