natgillin/translations-raw huggingface dataset:
Do not stop taking Prasugrel Mylan without consulting your doctor; if you stop taking Prasugrel Mylan too soon, your risk of a heart attack may be higher.
Če zdravilo Prasugrel Mylan prenehate jemati prezgodaj, je lahko pri vas tveganje za srčno kap večje.
Fatal
Smrtna
Respiratory, thoracic and mediastinal disorders
Bolezni dihal, prsnega koša in mediastinalnega prostora epitaksa hemoptiza
OPA/Aluminium/PE/Desiccant/PE- Aluminium perforated unit dose blister pack containing 30 x 1 or 90 x 1 film-coated tablets.
Pakiranja v perforiranih enoodmernih pretisnih omotih iz OPA/Al/PE/sušilno sredstvo/PE-Al, ki vsebujejo 30 x 1 ali 90 x 1 filmsko obloženo tableto.
What Prasugrel Mylan contains - The active substance is prasugrel.
Kaj vsebuje zdravilo Prasugrel Mylan - Učinkovina je prasugrel.
Sunset yellow FCF aluminium lake (E110) [only Prasugrel Mylan 10 mg]
Sončno rumeno barvilo FCF (E110) [samo Prasugrel Mylan 10 mg] Rdeči železov oksid (E172) [samo Prasugrel Mylan 10 mg]
Injury, poisoning and procedural complications
Poškodbe in zastrupitve in zapleti pri posegih udarnina pooperacijska krvavitev podkožni hematom
• Before you take Prasugrel Mylan:
• Preden vzamete zdravilo Prasugrel Mylan:
Prasugrel was administered without regard to food in TRITON.
Prasugrel so v študiji TRITON dajali neodvisno od hrane.
Your doctor should prescribe a daily dose of 5 mg as there is a greater risk of bleeding in patients older than 75 years - a recent serious injury - recent surgery (including some dental procedures) - recent or recurrent bleeding from the stomach or intestines (e.g. a stomach ulcer or colon polyps) body weight of less than 60 kg.
- nedavna resna poškodba, - nedavni kirurški poseg (vključno z nekaterimi zobozdravstvenimi posegi), - nedavna ali ponovna krvavitev iz želodca ali črevesja (npr. želodčni ulkus ali polipi debelega črevesja), telesna masa nižja od 60 kg.
Increased frequency (3-fold) and severity of bleeding may occur in patients undergoing CABG surgery within 7 days of discontinuation of prasugrel (see section 4.8).
V obdobju 7 dni po prekinitvi prasugrela se pri bolnikih, ki so imeli kirurški poseg aortokoronarnega obvoda (Coronary Artery Bypass Graft, CABG), lahko pojavita povečana pogostnost (3-kratna) in resnost krvavitve (glejte poglavje 4.8).
Because of the potential for increased risk of bleeding, warfarin and Prasugrel Mylan should be co-administered with caution (see section 4.4).
Zaradi možnega povečanega tveganja za krvavitev moramo previdno dajati sočasno varfarin in zdravilo Prasugrel Mylan (glejte poglavje 4.4).
Reduced prasugrel efficacy has been seen in patients co-administered prasugrel and morphine (see section 4.5).
Pri bolnikih, ki so sočasno prejemali prasugrel in morfin, so opazili zmanjšano učinkovitost prasugrela (glejte poglavje 4.5).
b Any intracranial haemorrhage or any clinically overt bleeding associated with a fall in haemoglobin ≥5 g/dL.
b Vsaka intrakranialna krvavitev ali klinično očitna krvavitev, povezana s padcem hemoglobina
If you forget to take Prasugrel Mylan
Če ste pozabili vzeti zdravilo Prasugrel Mylan
OPA/Aluminium/PE/Desiccant/PE- Aluminium blister packs containing 28, 30, 84, 90 or 98 filmcoated tablets.
Pakiranja v pretisnih omotih iz OPA/Al/PE/sušilno sredstvo/PE-Al, ki vsebujejo 28, 30, 84, 90 ali 98 filmsko obloženih tablet.
This is due to an increase in exposure to the active metabolite of prasugrel, and an increased risk of bleeding in patients with body weight <60 kg when given a 10 mg once daily dose compared with patients ≥60 kg (see sections 4.4, 4.8 and
Odmerjanje zdravila Prasugrel Mylan je treba začeti z enkratnim 60 mg polnilnim odmerkom in nato nadaljevati s 5 mg enkrat na dan. 10 mg vzdrževalni odmerek ni priporočljiv, in sicer zaradi večje izpostavljenosti aktivnemu presnovku prasugrela in povečanemu tveganju za krvavitev ob prejemanju 10 mg odmerka enkrat na dan pri bolnikih, ki tehtajo < 60 kg, v primerjavi z bolniki ≥ 60 kg (glejte poglavja 4.4, 4.8 in 5.2).
• Bleeding from a needle puncture site
• Krvavitev iz mesta vboda igle
CV death, nonfatal MI, or nonfatal stroke
Srčno-žilna smrt, ne-smrtni miokardni infarkt ali ne-smrtna možganska kap
If, after a careful individual benefit/risk evaluation by the prescribing physician (see section 4.4), treatment is deemed necessary in the patients age group ≥75 years, then following a 60 mg loading dose a reduced maintenance dose of 5 mg should be prescribed.
Če je po skrbni oceni lečečega zdravnika glede posameznikove koristi/tveganja (glejte poglavje 4.4) zdravljenje v starostni skupini bolnikov ≥ 75 let potrebno, mora biti po enkratnemu 60 mg polnilnemu odmerku predpisan nižji vzdrževalni odmerek 5 mg. Bolniki ≥ 75 let so bolj nagnjeni h krvavitvi in bolj izpostavljeni aktivnemu presnovku prasugrela (glejte poglavja 4.4, 4.8, 5.1 in 5.2).
The benefits and risks of prasugrel should be carefully considered in patients in whom the coronary anatomy has not been defined and urgent CABG is a possibility.
Pri bolnikih, pri katerih srčna anatomija ni določena in je možen nujni aortokoronarni obvod, je treba skrbno razmisliti o koristih in tveganjih prasugrela.
Thrombocytopaenia
Krospovidon
• While you are taking Prasugrel Mylan:
• Med jemanjem zdravila Prasugrel Mylan:
Eye haemorrhage
Okvara ledvic
Prasugrel Mylan is for oral use.
Zdravilo Prasugrel Mylan je za peroralno uporabo.
OPA/Aluminium/PE/Desiccant/PE- Aluminium blister packs containing 28, 30, 84 or 98 film-coated tablets.
Pakiranja v pretisnih omotih iz OPA/Al/PE/sušilno sredstvo/PE-Al, ki vsebujejo 28, 30, 84 ali 98 filmsko obloženih tablet.
c Any intracranial haemorrhage or any clinically overt bleeding associated with a fall in haemoglobin ≥5 g/dL.
c Vsaka intrakranialna krvavitev ali klinično očitna krvavitev, povezana s padcem hemoglobina
Prasugrel Mylan 5 mg film-coated tablets are yellow film-coated, capsule shaped, biconvex tablets, of dimensions 8.15 mm × 4.15 mm, debossed with ‘PH3' on one side of the tablet and ‘M' on the other side.
Prasugrel Mylan 5 mg: filmsko obložene tablete so rumene barve, v obliki kapsule, bikonveksne, velikosti 8,15 mm × 4,15 mm, z vtisnjenim »PH3« na eni strani in »M« na drugi strani.
Prasugrel Mylan 5 mg: Do not store above 30°C.
Prasugrel Mylan 5 mg: Shranjujte pri temperaturi do 30 °C.
• ‘non-steroidal anti-inflammatory drugs' for pain and fever (such as ibuprofen, naproxen, etoricoxib).
Še posebej je pomembno, da poveste svojemu zdravniku, če se zdravite s/z: klopidogrelom (zdravilom proti trombocitom), varfarinom (antikoagulantom), »nesteroidnimi protivnetnimi zdravili« za bolečino in vročino (kot je ibuprofen, naproksen, etorikoksib).
SPECIAL STORAGE CONDITIONS Do not store above 30°C.
Pakiranja v pretisnih omotih: Shranjujte pri temperaturi do 30 °C.
The mean exposure (AUC) of the active metabolite of prasugrel is approximately 30 to 40% higher in healthy subjects and patients with a body weight of <60 kg compared to those weighing ≥60 kg.
Srednja izpostavljenost (AUC) aktivnemu presnovku prasugrela je približno 30-40 % višja pri zdravih osebah in bolnikih s telesno maso < 60 kg, v primerjavi s tistimi, ki tehtajo ≥ 60 kg. Prasugrel moramo uporabljati previdno pri bolnikih s telesno maso < 60 kg, zaradi možnega tveganja za krvavitev v tej populaciji (glejte poglavje 4.4).
Prasugrel
Smukec
Thrombotic thrombocytopaenic purpura (TTP)
Trombotična trombocitopenična purpura (TTP) Pri uporabi prasugrela so poročali o TTP.
Prasugrel Mylan 5 mg film-coated tablets Prasugrel Mylan 10 mg film-coated tablets prasugrel
Prasugrel Mylan 5 mg filmsko obložene tablete Prasugrel Mylan 10 mg filmsko obložene tablete prasugrel
Each tablet contains prasugrel besilate equivalent to 10 mg prasugrel.
Ena tableta vsebuje prasugrel besilat, kar ustreza 10 mg prasugrela.
Yellow film-coated, capsule shaped, biconvex tablet, of dimensions 8.15 mm × 4.15 mm, debossed with ‘PH3' on one side and ‘M' on the other side.
Rumena bikonveksna filmsko obložena tableta v obliki kapsule, velikosti 8,15 mm × 4,15 mm, z vtisnjeno oznako »PH3« na eni in »M« na drugi strani.
Prasugrel Mylan 10 mg film-coated tablets are beige film-coated, capsule shaped, biconvex tablets, of dimensions 11.15 mm × 5.15 mm, debossed with ‘PH4' on one side of the tablet and ‘M' on the other side.
Prasugrel Mylan 10 mg: filmsko obložene tablete so bež barve, v obliki kapsule, bikonveksne, velikosti 11,15 mm × 5,15 mm, z vtisnjenim »PH4« na eni strani in »M« na drugi strani.
BOTTLE CARTON AND BOTTLE LABEL OF 10 MG FILM-COATED TABLETS
ŠKATLA ZA PLASTENKO IN NALEPKA NA PLASTENKI 10 MG FILMSKO OBLOŽENIH TABLET
• Bruising
• Modrice
BOTTLE CARTON AND BOTTLE LABEL OF 5 MG FILM-COATED TABLETS
ŠKATLA ZA PLASTENKO IN NALEPKA NA PLASTENKI 5 MG FILMSKO OBLOŽENIH TABLET
Sodium lauryl sulfate
Gliceril monokaprilat monokaprinat Natrijev lavril sulfat
Prasugrel Mylan 5 mg film-coated tablets prasugrel
Prasugrel Mylan 5 mg filmsko obložene tablete prasugrel
Prasugrel Mylan 10 mg: Each tablet contains prasugrel besilate equivalent to 10 mg prasugrel.
Prasugrel Mylan 10 mg: Ena tableta vsebuje prasugrel besilat v količini, ki ustreza 10 mg prasugrela.
Prasugrel Mylan 5 mg: Each tablet contains prasugrel besilate equivalent to 5 mg prasugrel.
Prasugrel Mylan 5 mg: Ena tableta vsebuje prasugrel besilat v količini, ki ustreza 5 mg prasugrela.
How to store Prasugrel Mylan
Kako jemati zdravilo Prasugrel Mylan
Each tablet contains prasugrel besilate equivalent to 5 mg prasugrel.
Ena tableta vsebuje prasugrel besilat, kar ustreza 5 mg prasugrela.
Always take Prasugrel Mylan exactly as your doctor has told you.
Pri jemanju tega zdravila Prasugrel Mylan natančno upoštevajte navodila zdravnika.
Prasugrel Mylan 10 mg film-coated tablets prasugrel
Prasugrel Mylan 10 mg filmsko obložene tablete prasugrel
Beige film-coated, capsule shaped, biconvex tablet, of dimensions 11.15 mm × 5.15 mm, debossed with ‘PH4' on one side and ‘M' on the other side.
Bež bikonveksna filmsko obložena tableta v obliki kapsule, velikosti 11,15 mm × 5,15 mm, z vtisnjeno oznako »PH4« na eni in »M« na drugi strani.
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.
Če opazite katerega koli izmed neželenih učinkov, se posvetujte z zdravnikom ali farmacevtom.
Non-fatal MI
Smrtno nevarna d
BLISTER CARTON OF 5 MG FILM-COATED TABLETS
PRETISNI OMOT 5 MG FILMSKO OBLOŽENIH TABLET
Blister packs only: Do not store above 30°C.
Samo za pretisne omote: Shranjujte pri temperaturi do 30 °C.
Prasugrelb + ASA (N=6741)
ASK (N = 6741)
Requiring inotropes Requiring surgical intervention Requiring transfusion (≥4 units) TIMI minor bleedingf a Centrally adjudicated events defined by the Thrombolysis in Myocardial Infarction (TIMI) Study
f a Centralno določeni dogodki, definirani po kriterijih preiskovane skupine za trombolizo pri miokardnem infarktu (Thrombolysis in Myocardial Infarction, TIMI).
BLISTER CARTON OF 10 MG FILM-COATED TABLETS
PRETISNI OMOT 10 MG FILMSKO OBLOŽENIH TABLET
NAME OF THE MEDICINAL PRODUCT Prasugrel Mylan 5 mg film-coated tablets Prasugrel Mylan 10 mg film-coated tablets
Prasugrel Mylan 5 mg filmsko obložene tablete Prasugrel Mylan 10 mg filmsko obložene tablete
Non-CABG-related TIMI major or minor bleeding rates: Weight
Bolniki < 60 kg Stopnje večjih in manjših krvavitev po TIMI, nepovezanih z aortokoronarnim obvodom:
Prasugrel Mylan 10 mg: Do not store above 25°C.
Prasugrel Mylan 10 mg: Shranjujte pri temperaturi do 25 °C.
carton only:
Samo na škatli: PC:
CV death
Srčno-žilna smrt
SPECIAL STORAGE CONDITIONS Do not store above 25°C.
Shranjujte pri temperaturi do 25 °C.
Table 1: Incidence of Non-CABG related bleedinga (% Patients)
Preglednica 1: Incidenca krvavitev, nepovezanih z aortokoronarnim obvodom a
You will start the treatment with a single dose of 60 mg.
Običajen odmerek zdravila Prasugrel Mylan je 10 mg na dan. Vaše zdravljenje boste začeli z enkratnim odmerkom 60 mg.
Your doctor may wish you to stop taking Prasugrel Mylan temporarily due to the increased risk of bleeding
Vaš zdravnik vam bo morda naročil, da začasno prenehate jemati zdravilo
Prasugrelb + ASA (N=5001)
ASK (N = 5001)
Talk to your doctor before taking Prasugrel Mylan.
Pred začetkom jemanja zdravila Prasugrel Mylan se posvetujte z zdravnikom.
It was to be used in combination with other medicines.
Uporabljalo naj bi se v kombinaciji z drugimi zdravili.
It was to be available as capsules (120 mg).
Na voljo naj bi bilo v obliki kapsul (120 mg).
Remaining clinical trials were expected to finish on schedule by July 2014.
Preostala klinična preskušanja naj bi se zaključila do julija 2014, kot je bilo predvideno.
27 June 2014 EMA/354906/2014 EMEA/H/C/003720
EMA/445627/2014 EMEA/H/C/003720
The application was withdrawn after the CHMP had evaluated the initial documentation provided by the company and formulated a list of questions.
Vlogo so umaknili potem, ko je CHMP ocenil začetno dokumentacijo, ki jo je predložila družba, in oblikoval seznam vprašanj.
In addition, results of tests on capsules stored in nonrefrigerated conditions showed that they did not dissolve as expected, which could affect the release of the active substance from the capsule.
Poleg tega so rezultati preskusov na kapsulah, ki niso bile hranjene v hladilniku, pokazali, da se kapsule niso raztopile v skladu s pričakovanji, kar bi lahko vplivalo na sproščanje zdravilne učinkovine iz nje.
The company presented data including the results of three main studies involving 1,705 patients with chronic hepatitis C, in which faldaprevir was compared with placebo (a dummy treatment) when added to two other medicines for hepatitis C, peginterferon and ribavirin.
Družba je predložila podatke, med katerimi so bili tudi rezultati treh glavnih študij, v katere so vključili 1 705 bolnikov s kroničnim hepatitisom C in v katerih so primerjali faldaprevir in placebo (zdravilo brez zdravilne učinkovine), ki so ju dodajali dvema drugima zdraviloma za hepatitis C, peginterferonu in ribavirinu.
The main measure of effectiveness was the number of patients whose blood tests did not show any sign of hepatitis C virus 12 weeks after
Glavno merilo učinkovitosti je bilo število bolnikov, pri katerih preiskave krvi 12 tednov po končanem zdravljenju niso pokazale nobenih znakov virusa hepatitisa C. V četrti študiji, v katero so
In its letter notifying the Agency of the withdrawal of application, the company stated that since several new treatments for hepatitis C had become available after the application was first made, there was no longer an unmet medical need for such a medicine.
Družba je v dopisu, s katerim agencijo obvešča o umiku vloge, navedla, da je od prvotne predložitve vloge bilo danih na voljo več novih zdravil za hepatitis C, tako da je potreba po tovrstnem zdravilu izpolnjena.
On 10 June 2014, Boehringer Ingelheim International GmbH officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Faldaprevir Boehringer Ingelheim, for the treatment of hepatitis C.
Družba Boehringer Ingelheim International GmbH je dne 10. junija 2014 uradno obvestila Odbor za zdravila za uporabo v humani medicini (CHMP), da želi umakniti vlogo za pridobitev dovoljenja za promet z zdravilom Faldaprevir Boehringer Ingelheim, namenjenim zdravljenju hepatitisa C.
Several varieties (genotypes) of hepatitis C virus exist: Faldaprevir Boehringer Ingelheim was intended to be used against genotype 1.
Obstaja več vrst (genotipov) virusa hepatitisa C: zdravilo Faldaprevir Boehringer Ingelheim naj bi se uporabljalo proti genotipu 1.
A fourth study involving 308 patients examined the effects of treatment with Faldeprevir Boehringer Ingelheim in patients who also had HIV infection.
vključili 308 bolnikov, so proučili učinke zdravljenja z zdravilom Faldaprevir Boehringer Ingelheim pri bolnikih, ki so bili okuženi tudi z virusom HIV.
Based on the review of the data, at the time of the withdrawal, the CHMP had had some concerns and was of the provisional opinion that Faldaprevir Boehringer Ingelheim could not have been approved for the treatment of hepatitis C. The Committee had concerns regarding the starting materials used for the manufacture of the active substance.
Na podlagi pregleda podatkov je CHMP v času umika izrazil določene zadržke in je začasno menil, da zdravila Faldaprevir Boehringer Ingelheim ni mogoče odobriti za zdravljenje hepatitisa C. Odbor je imel pomisleke glede vhodnih snovi, ki so bile uporabljene za izdelavo zdravilne učinkovine.
The company informed the CHMP that there are no consequences for patients currently included in clinical trials using Faldaprevir Boehringer Ingelheim.
Družba je obvestila odbor CHMP, da umik nima nobenih posledic za bolnike, ki trenutno sodelujejo v kliničnih preskušanjih zdravila Faldaprevir Boehringer Ingelheim.
Faldaprevir Boehringer Ingelheim is an antiviral medicine that contains the active substance faldaprevir.
Faldaprevir Boehringer Ingelheim je protivirusno zdravilo, ki vsebuje zdravilno učinkovino faldaprevir.
Faldaprevir Boehringer Ingelheim was expected to be used to treat adults with chronic (long-term) hepatitis C (an infectious disease that affects the liver, caused by the hepatitis C virus).
Zdravilo Faldaprevir Boehringer Ingelheim naj bi se uporabljalo za zdravljenje odraslih s kroničnim (dolgotrajnim) hepatitisom C (infekcijsko boleznijo, ki jo povzroča virus hepatitisa C in ki prizadene jetra).
Therefore, up to the time of the withdrawal, the CHMP was of the opinion that due to the concerns about quality the benefits of Faldaprevir Boehringer Ingelheim did not outweigh its risks.
Zato je CHMP v času umika menil, da zaradi pomislekov glede kakovosti koristi zdravila Faldaprevir Boehringer Ingelheim ne odtehtajo z njim povezanih tveganj.
The active substance in Faldaprevir Boehringer Ingelheim, faldaprevir, blocks the action of an enzyme called ‘NS3/4A serine protease' in the hepatitis C virus, which is essential for the virus to multiply.
Zdravilna učinkovina v zdravilu Faldaprevir Boehringer Ingelheim, faldaprevir, zavira delovanje encima v virusu hepatitisa C, imenovanega „serinska proteaza NS3/4A“, ki ima ključno vlogo pri razmnoževanju virusa.
What is Faldaprevir Boehringer Ingelheim?
Kaj je zdravilo Faldaprevir Boehringer Ingelheim?
How is Faldaprevir Boehringer Ingelheim expected to work?
Kako naj bi zdravilo Faldaprevir Boehringer Ingelheim delovalo?
What was Faldaprevir Boehringer Ingelheim expected to be used for?
Za kaj naj bi se zdravilo Faldaprevir Boehringer Ingelheim uporabljalo?
4 years
4 leti
>R (Resistant)
>R (Odporni)
[Mechanism of interaction]
[mehanizem interakcije]
Difference in proportions and the 95% confidence interval (CI)
Razlike v deležih in 95odstotni interval zaupanja (IZ)
The following instructions apply to both treatment and prophylaxis
Naslednja navodila veljajo tako za zdravljenje kot tudi za profilakso
• Existing symptomatic arrhythmias.
• obstoječe simptomatske aritmije
Success at day 180*
Uspešnost na 180. dan*
Date of latest renewal: 8th February 2018
Datum prve odobritve: 16. maj 2013 Datum zadnjega podaljšanja: 8. februarja 2018
Maximum increase in prothrombin time was approximately 2-fold
največje podaljšanje protrombinskega časa je bilo približno 2-kratno
Clinical efficacy defined as partial or complete response, has been demonstrated for Aspergillus spp.
Klinična učinkovitost, opredeljena kot delni ali popolni odziv, je bila dokazana za Aspergillus spp.,
Oral Contraceptives*
Peroralni kontraceptivi*
This study confirmed findings from an earlier, prospectively designed study where there was a positive outcome in subjects with risk factors for a poor prognosis, including graft versus host disease, and, in particular, cerebral infections (normally associated with almost 100% mortality).
Ta študija je potrdila izsledke zgodnejše, prospektivne študije, v kateri so ugotovili pozitiven izid pri preiskovancih z dejavniki tveganja za slabo prognozo, vključno z boleznijo presadka proti gostitelju in, še posebej, možganskimi okužbami (ki so običajno povezane s skoraj 100-odstotno umrljivostjo).
Other Candida spp.4
Druge Candida spp.4
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).
Pogostnosti pojavljanja neželenih učinkov so opredeljene po naslednjih skupinah: zelo pogosti (≥ 1/10), pogosti (> 1/100 in < 1/10), občasni (> 1/1.000 in < 1/100), redki (> 1/10.000 in < 1/1.000), zelo redki (< 1/10.000), neznana pogostnost (ni mogoče oceniti iz razpoložljivih podatkov).
If you take more Voriconazole Accord than you should 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.
Če ste vzeli večji odmerek zdravila Vorikonazol Accord, kot bi smeli Če vzamete več tablet, kot je predpisano (ali če kdo drug vzame vaše tablete), morate takoj poiskati zdravniški nasvet ali se takoj zglasiti v ambulanti za nujno pomoč najbližje bolnišnice.
The recommended dose for children and teenagers is as follows:
Priporočeni odmerek za otroke in najstnike je:
Seven (3 complete, 4 partial responses) of 17 patients were successfully treated with voriconazole.
Sedem (3 popolni, 4 delni odzivi) od 17 bolnikov je bilo uspešno zdravljenih z vorikonazolom.
Contraindicated (see section 4.3)
Kontraindicirano (glejte poglavje 4.3)
Interactions between voriconazole and other medicinal products are listed in the table below (once daily as “QD”, twice daily as “BID”, three times daily as “TID” and not determined as “ND”).
Interakcije med vorikonazolom in drugimi zdravili so navedene v spodnji preglednici (enkrat na dan kot »QD«, dvakrat na dan kot »BID«, trikrat na dan kot »TID« in ni določeno kot »ND«).
The direction of the arrow for each pharmacokinetic parameter is based on the 90% confidence interval of the geometric mean ratio being within (↔), below (↓) or above (↑) the 80-125% range.
Smer puščice za vsak farmakokinetični parameter temelji na 90-odstotnem intervalu zaupanja razmerja geometrične srednje vrednosti, ki je lahko znotraj (↔), pod (↓) ali nad (↑) območjem 80-125 %.
Macrolide antibiotics Erythromycin (1 g BID)
Makrolidni antibiotiki eritromicin (1 g BID)
Prophylaxis in adults and children
Profilaksa pri odraslih in otrocih
Do not take Voriconazole Accord If you are allergic to voriconazole or any of the other ingredients of this medicine (listed in section 6).
Ne jemljite zdravila Vorikonazol Accord Če ste alergični na vorikonazol ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
Success was defined as the ability to continue study drug prophylaxis for 100 days after HSCT (without stopping for >14 days) and survival with no proven or probable IFI for 180days after HSCT.
Uspešnost je bila opredeljena kot zmožnost nadaljevanja profilakse s preiskovanim zdravilom 100 dni po HSCT (brez prekinitve > 14 dni) in preživetje 180 dni po HSCT brez dokazane ali verjetne IGO.
This metabolite has minimal antifungal activity and does not contribute to the overall efficacy of voriconazole.
Ta presnovek deluje minimalno antimikotično in ne prispeva k celotni učinkovitosti vorikonazola.
Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu
Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila http://www.ema.europa.eu/
The pharmacokinetics of voriconazole have been characterised in healthy subjects, special populations and patients.
Farmakokinetika vorikonazola je bila opredeljena pri zdravih osebah, posebnih populacijah in bolnikih.
Children and adolescents Voriconazole Accord should not be given to children younger than 2 years of age.
Otroci in mladostniki Zdravila Vorikonazol Accord ne smejo dobiti otroci, mlajši od 2 let.
One study enrolled 31 patients with possible, proven or probable invasive aspergillosis (IA), of whom 14 patients had proven or probable IA and were included in the MITT efficacy analyses.
31 bolnikov z možno, potrjeno ali verjetno invazivno aspergilozo (IA), od katerih je 14 bolnikov imelo potrjeno ali verjetno IA in so jih vključili v analize učinkovitosti MITT.