natgillin/translations-raw huggingface dataset:
Alternatively, the volume (ml)c of reconstituted CANCIDAS can be added to a reduced volume of 0.9%, 0.45%, or 0.225% Sodium Chloride Injection or Lactated Ringers Injection, not to exceed a final concentration of 0.5 mg/ ml.
Druga možnost je, da količino (ml) c pripravljene raztopine CANCIDAS dodate zmanjšani količini 0, 9%, 0, 45% ali 0, 225% raztopine natrijevega klorida za injekcije ali raztopine Ringerjevega laktata, vendar končna koncentracija ne sme preseči 0, 5 mg/ ml.
This infusion solution must be used within 24 hours if stored at ≤ 25°C (≤ 77°F) or within 48 hours if stored refrigerated at 2 to 8°C (36 to 46°F).
Raztopino za infundiranje je treba uporabiti v 24 urah, če je shranjena pri temperaturi ≤ 25 °C, ali v 48 urah, če je shranjena v hladilniku (pri temperaturi od 2 do 8 °C).
Preparation of the 50 mg/ m2 infusion for paediatric patients > 3 months of age (using a 50-mg vial) 1.
14 Priprava infuzije 50 mg/ m2 za pediatrične bolnike, stare > 3 mesece (z uporabo 50- mg viale) 1.
BSA (m2) X 50 mg/ m2 = Daily Maintenance Dose The daily maintenance dose should not exceed 70 mg regardless of the patient's calculated dose.
Telesna površina (m2) X 50 mg/ m2 = dnevni vzdrževalni odmerek Dnevni vzdrževalni odmerek ne sme preseči 70 mg, ne glede na izračunani odmerek za bolnika.
Aseptically add 10.5 ml of 0.9% Sodium Chloride Injection, Sterile Water for Injection or Bacteriostatic Water for Injection with methylparaben and propylparaben. a This reconstituted
Aseptično dodajte 10, 5 ml 0, 9% raztopine natrijevega klorida za injekcije, sterilne vode za injekcije ali bakteriostatične vode za injekcije z metilparabenom in propilparabenom. a Pripravljeno raztopino lahko shranite do 1 uro pri temperaturi ≤ 25 °C. b Končna koncentracija kaspofungina v viali bo tako 5, 2 mg/ ml.
Remove the volume of drug equal to the calculated daily maintenance dose (Step 1) from the vial.
Potegnite iz viale količino zdravila, ki ustreza izračunanemu dnevnemu vzdrževalnemu odmerku (1. korak).
The white to off-white cake will dissolve completely.
Bela ali skoraj bela pogača se bo povsem raztopila.
Mix gently until a clear solution is obtained.
Obzirno mešajte, dokler ne dobite bistre raztopine.
Do not use if the solution is cloudy or has precipitated.
Raztopine ne uporabite, če je motna ali se je pojavil precipitat.
CANCIDAS is formulated to provide the full labeled vial dose (50 mg) when 10 ml is withdrawn from the vial.
Zdravilo CANCIDAS je pripravljeno tako, da zagotavlja polni na viali označeni odmerek (50 mg), če iz viale potegnete 10 ml.
24 October 2001.
24. oktober 2001.
Each vial contains 70 mg caspofungin (as acetate).
Ena viala vsebuje 70 mg kaspofungina (v obliki acetata).
Each 70 mg vial contains 50.0 mg of sucrose.
Vsaka viala vsebuje 50, 0 mg saharoze.
16 Dosage in paediatric patients (12 months to 17 years) In paediatric patients (12 months to 17 years of age), dosing should be based on the patient’ s body surface area (see Instructions for Use in Paediatric Patients, Mosteller 2 Formula).
16 Odmerjanje pri pediatričnih bolnikih (starih od 12 mesecev do 17 let) Pri pediatričnih bolnikih (starih od 12 mesecev do 17 let) je treba odmerjanje določiti glede na bolnikovo telesno površino (glejte Navodila za uporabo pri pediatričnih bolnikih, Mostellerjeva 2 formula).
After signs and symptoms of invasive candidiasis have improved and cultures have become negative, a switch to oral antifungal therapy may be considered.
Ko se znaki in sim ptomi invazivne kandidiaze izboljšajo in kulture postanejo negativne, je mogoče razmisliti o prehodu na peroralno antimikotično zdravljenje.
An initial 70 mg loading dose should be administered on Day 1.
Prvi dan je treba dati uvodni 70- mg uvajalni odmerek.
There is no clinical experience in adult patients with severe hepatic insufficiency (Child-Pugh score greater than 9) and in paediatric patients with any degree of hepatic insufficiency (see section 4.4).
Kliničnih izkušenj pri odraslih bolnikih s hudo jetrno okvaro (stopnja Child- Pugh nad 9 točk) in pri pediatričnih bolnikih ne glede na stopnjo okvare jeter nimamo (glejte poglavje 4. 4).
Co-administration with inducers of metabolic enzymes Limited data suggest that an increase in the daily dose of CANCIDAS to 70 mg, following the 70 mg loading dose, should be considered when co-administering CANCIDAS in adult patients with certain inducers of metabolic enzymes (see section 4.5).
Nekateri podatki nakazujejo, da je treba pri odraslih bolnikih v primeru sočasne uporabe zdravila CANCIDAS z določenimi induktorji presnovnih encimov razmisliti o povečanju dnevnega odmerka zdravila CANCIDAS na 70 mg (po 70- mg uvajalnem odmerku) (glejte poglavje 4. 5).
17 4.3 Contraindications
17 4. 3 Kontraindikacije
Limited data suggest that less common non-Candida yeasts and non-Aspergillus moulds are not covered by caspofungin.
Nekaj podatkov kaže, da kaspofungin morda ne deluje proti manj običajnim glivam, vendar ne iz rodu Candida ali Aspergillus.
Patients with rare hereditary problems of fructose intolerance or sucrase– isomaltase insufficiency should not take this medicinal product.
Bolniki z redko dedno intoleranco za fruktozo ali insuficienco sukraze – izomaltaze ne smejo jemati tega zdravila.
18 rifampicin or mycophenolate mofetil.
18 Klinične raziskave pri zdravih odraslih prostovoljcih kažejo, da itrakonazol, amfotericin B, mikofenolat, nelfinavir in takrolimus farmakokinetike zdravila CANCIDAS ne spremenijo v klinično pomembni meri.
No studies on the effects on the ability to drive and use machines have been performed.
Študij o vplivu na sposobnost vožnje in upravljanja s stroji niso izvedli..
19 Reported clinical and laboratory abnormalities among all adult patients treated with CANCIDAS (total 989) were typically mild and rarely led to discontinuation.
Klinične in laboratorijske nepravilnosti, o katerih so poročali, so bile pri vseh odraslih bolnikih, zdravljenih z zdravilom CANCIDAS (skupno 989), ponavadi blage in so le redko vodile v prekinitev zdravljenja.
High calcium has been reported as uncommon (≥ 1/ 1000, < 1/ 100).
O visoki koncentraciji kalcija so poročali redko (≥ 1/ 1000, < 1/ 100).
Possible histamine-mediated symptoms have been reported including reports of rash, facial swelling, pruritus, sensation of warmth, or bronchospasm.
Poročali so o simptomih, pri katerih bi posrednik lahko bil histamin, vključno s posameznimi primeri izpuščaja, otekanja obraza, srbenja, občutka toplote ali bronhospazma.
Also reported in patients with invasive aspergillosis were pulmonary oedema, adult respiratory distress syndrome (ARDS), and radiographic infiltrates.
Pri bolnikih z invazivno aspergilozo so opisani tudi pljučni edem, sindrom dihalne stiske pri odraslih (ARDS) in rentgensko vidni infiltrati.
Paediatric Patients In clinical studies, 171 paediatric patients received single or multiple doses of CANCIDAS:
20 Pediatrični bolniki V kliničnih raziskavah je posamične ali večkratne odmerke zdravila CANCIDAS dobilo 171 pediatričnih bolnikov:
20 [Very common (≥ 1/ 10), Common (≥ 1/ 100, < 1/ 10)]
[Zelo pogosti (≥1/ 10), pogosti (≥1/ 100, < 1/ 10)]
5.1 Pharmacodynamic properties
21 5. 1 Farmakodinamične lastnosti
Pharmacotherapeutic group: antimycotics for systemic use, ATC Code:
Farmakoterapevtska skupina: antimikotiki za sistemsko zdravljenje, oznaka ATC:
21 Fungicidal activity with caspofungin has been demonstrated against Candida yeasts.
Fungicidno delovanje kaspofungina je bilo dokazano proti kvasovkam vrste Candida.
In limited clinical experience, resistance to caspofungin in patients with invasive aspergillosis has not been observed.
V omejenih kliničnih izkušnjah odpornosti na kaspofungin pri bolnikih z invazivno aspergilozo niso opazili.
Caspofungin 50 mg once daily was administered following a 70-mg loading dose, while amphotericin B was administered at 0.6 to 0.7 mg/ kg/ day to non-neutropaenic patients or 0.7 to 1.0 mg/ kg/ day to neutropaenic patients.
Amfotericin B so pri nenevtropeničnih bolnikih uporabljali v odmerku 0, 6 do 0, 7 mg/ kg/ dan, pri nevtropeničnih pa v odmerku 0, 7 do 1, 0 mg/ kg/ dan.
Among patients with candidaemia, favourable response rates at the end of IV study therapy were comparable for caspofungin (72% [66/ 92]) and amphotericin B (63% [59/ 94]) in the primary efficacy analysis (MITT analysis) [% difference 10.0 (95.0% CI -4.5, 24.5)].
Med bolniki s kandidemijo sta bila deleža ugodnega odziva na koncu intravenskega raziskovanega zdravljenja v analizi primarne učinkovitosti (analiza MITT) pri kaspofunginuu (72% [66/ 92]) in amfotericinu B (63% [59/ 94]) podobna [% razlike 10, 0 (95, 0% CI - 4, 5, 24, 5)].
Invasive Aspergillosis in Adult Patients:
Invazivna aspergiloza pri odraslih bolnikih:
Sixty-nine adult patients (age 18-80) with invasive aspergillosis were enrolled in an open-label, non-comparative study to evaluate the safety, tolerability, and efficacy of caspofungin.
Bolniki so morali biti nedovzetni za druga standardna protiglivična
Patients had to be either refractory to (disease progression or failure to improve with other antifungal therapies given for at least 7 days) (84% of the enrolled patients) or intolerant of (16% of enrolled patients) other standard antifungal therapies.
22 zdravila (napredovanje bolezni ali nespremenjeno stanje ob vsaj 7 dnevnem prejemanju drugih protiglivičnih zdravil) (84% vključenih bolnikov) ali jih niso smeli prenašati (16% vključenih bolnikov).
The study design, diagnostic criteria, and criteria for efficacy assessment were similar to the corresponding studies in adult patients (see section 5.1).
Primerjala je zdravilo CANCIDAS (50 mg/ m2 intravensko enkrat na dan po uvajalnem odmerku
The first study, which enrolled 82 patients between 2 to 17 years of age, was a randomized, double- blind study comparing CANCIDAS (50 mg/ m2 IV once daily following a 70-mg/ m2 loading dose on Day 1 [not to exceed 70 mg daily]) to liposomal amphotericin B (3 mg/ kg IV daily) in a 2:1 treatment fashion (56 on caspofungin, 26 on liposomal amphotericin B) as empirical therapy in paediatric patients with persistent fever and neutropenia.
23 70 mg/ m2 1. dan [a ne več kot 70 mg na dan]) in liposomski amfotericin B (3 mg/ kg intravensko na dan) v razporedu zdravljenja 2: 1 (56 na kaspofunginu, 26 na liposomskem amfotericinu B) kot empirično zdravljenje pediatričnih bolnikov z dolgotrajno zvišano telesno temperaturo in nevtropenijo.
In vitro studies show that caspofungin is not an inhibitor of cytochrome P450 enzymes 1A2, 2A6, 2C9, 2C19, 2D6, or 3A4.
Raziskave in vitro kažejo, da kaspofungin ne zavira citokrom P450 encimov 1A2, 2A6, 2C9, 2C19, 2D6 ali 3A4.
Special populations Increased caspofungin exposure was seen in adult patients with renal impairment and mild liver impairment, in female subjects, and in the elderly.
24 Večjo izpostavitev kaspofunginu so opazili pri odraslih bolnikih z ledvično okvaro in blago jetrno okvaro, pri ženskah in pri starejših.
There is no clinical experience in adult patients with severe hepatic insufficiency and in paediatric patients with any degree of hepatic insufficiency.
Kliničnih izkušenj pri odraslih bolnikih s hudo jetrno okvaro in pri pediatričnih bolnikih ne glede na stopnjo okvare jeter nimamo.
24 hepatic impairment has been shown to provide an AUC similar to that obtained in adult subjects with normal hepatic function receiving the standard regimen (see section 4.2).
V raziskavi z večkratnimi odmerki je bila AUC pri odraslih bolnikih z zmerno jetrno okvaro po zmanjšanju dnevnega odmerka na 35 mg podobna kot AUC pri odraslih preiskovancih z normalnim delovanjem jeter, ki so dobivali običajen odmerek (glejte poglavje 4. 2).
Overall, the available pharmacokinetic, efficacy, and safety data are limited in patients 3 to 10 months of age.
V celoti so podatki o farmakokinetiki, učinkovitosti in varnosti, ki so na voljo, omejeni na bolnike, stare od 3 do 10 mesecev.
Pharmacokinetic data from one 10-month old child receiving the 50 mg/ m2 daily dose indicated an AUC0-24hr within the same range as that observed in older children and adults at the 50 mg/ m2 and the 50 mg dose, respectively, while in one 6-month old child receiving the 50 mg/ m2 dose, the AUC0-24hr was somewhat higher.
25 50 mg/ m2 na dan, pokazali AUC0- 24h v enakem območju, kot je bila pri starejših otrocih med uporabo 50 mg/ m2 in odraslih med uporabo 50- mg odmerka, pri enem 6- mesečnem otroku, ki je dobival 50 mg/ m2, pa je bila AUC0- 24h nekoliko večja.
25 5.3 Preclinical safety data
5. 3 Predklinični podatki o varnosti
Stability data have shown that the product can be used within 24 hours when stored at 25°C or less, or within 48 hours when the intravenous infusion bag (bottle) is stored refrigerated (2 to 8°C) and diluted with sodium chloride solution 9 mg/ ml (0.9%), 4.5 mg/ ml (0.45%), or 2.25 mg/ ml (0.225%) for infusion, or lactated Ringer’ s solution.
Stabilnostni podatki kažejo, da raztopino, ki smo jo pripravili z raztopino natrijevega klorida za infundiranje 9 mg/ ml (0, 9%), 4, 5 mg/ ml (0, 45%) ali 2, 25 mg/ ml (0, 225%) ali raztopino Ringerjevega laktata, lahko uporabimo v 24 urah, če smo jo shranjevali pri 25 °C ali manj, oziroma v 48 urah, če smo infuzijsko vrečo (steklenico) hranili v hladilniku (med 2 in 8 °C).
CANCIDAS contains no preservatives.
26 Zdravilo CANCIDAS ne vsebuje konzervansov.
For storage conditions of the reconstituted and diluted medicinal product, see section 6.3.
Za pogoje shranjevanja rekonstituiranega ali raztopljenega zdravila glejte poglavje 6. 3.
26 6.5 Nature and contents of container
6. 5 Vrsta ovojnine in vsebina
10 ml Type I glass vials with a grey butyl stopper and a plastic cap with a yellow/ orange aluminium band for single use only.
10 ml steklena viala tipa I s sivim zamaškom iz butilne gume in plastično zaporko z rumeno/ oranžnim aluminijastim obročkom, samo za enkratno uporabo.
Step 1 Reconstitution of conventional vials To reconstitute the powder bring the vial to room temperature and aseptically add 10.5 ml of water for injections.
1. korak priprava koncentrata Za pripravo koncentrata prenesite vialo na sobno temperaturo in vanjo aseptično dodajte 10, 5 ml vode za injekcije.
7.2 mg/ ml.
Koncentracija pripravljenega koncentrata bo 7, 2 mg/ ml.
Chemical and physical in-use stability of the diluted solution in sterile lactated Ringer’ s solution and sodium chloride solution 9 mg/ ml (0.9%), 4.5 mg/ ml (0.45%), and 2.25 mg/ ml (0.225%) for infusion has been demonstrated for 24 hours at 25°C and for 48 hours at 2 to 8°C.
Kemijska in fizikalna stabilnost pripravljene raztopine v sterilni raztopini Ringerjevega laktata ali raztopini natrijevega klorida za infundiranje 9 mg/ ml (0, 9%), 4, 5 mg/ ml (0, 45%) ali 2, 25 mg/ ml
From a microbiological point of view, the solution must be used immediately.
27 (0, 225%) pri temperaturi 25 °C je bila dokazana za obdobje 24 ur po pripravi, pri temperaturi med 2 in 8 °C (hladilnik) pa za obdobje 48 ur po pripravi.
If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8°C, unless reconstitution and dilution has taken place in controlled and validated aseptic conditions.
Normalno naj ta čas ne bi bil daljši od 24 ur, če raztopino shranjujemomed 2 in 8 °C, razen če sta priprava in razredčenje potekala v kontroliranih, validiranih aseptičnih pogojih.
27 PREPARATION OF THE SOLUTION FOR INFUSION IN ADULTS
PRIPRAVA RAZTOPINE ZA INFUNDIRANJE ZA ODRASLE
(from two 50 mg vials)** 35 mg for moderate
(iz dveh vial po 50 mg) ** 35 mg za zmerno
hepatic insufficiency (from one 70 mg vial)
jetrno odpoved (iz ene 70 mg viale)
0.14 mg/ ml
0. 14 mg/ ml
0.33 mg/ ml
0. 33 mg/ ml
* 10.5 ml should be used for reconstitution of all vials **If 70 mg vial is not available, the 70 mg dose can be prepared from two 50 mg vials
* Za pripravo koncentrata je treba vedno uporabiti 10, 5 ml topila. ** Če viale po 70 mg ni na voljo, lahko odmerek 70 mg pripravimo iz dveh 50 mg vial.
Preparation of the 70 mg/ m2 infusion for paediatric patients > 3 months of age (using a 70-mg vial) 1.
Priprava infuzije 70 mg/ m2 za pediatrične bolnike, stare > 3 mesece (z uporabo 70- mg viale) 1.
Aseptically add 10.5 ml of 0.9% Sodium Chloride Injection, Sterile Water for Injection or Bacteriostatic Water for Injection with methylparaben and propylparaben. a This reconstituted solution may be stored for up to one hour at ≤ 25°C (≤ 77°F). b This will give a final caspofungin concentration in the vial of 7.2 mg/ ml.
Aseptično dodajte 10, 5 ml 0, 9% raztopine natrijevega klorida za injekcije, sterilne vode za injekcije ali bakteriostatične vode za injekcije z metilparabenom in propilparabenom. a Pripravljeno raztopino lahko shranite do 1 uro pri temperaturi ≤ 25 °C. b Končna koncentracija kaspofungina v viali bo tako 7, 2 mg/ ml.
Preparation of the 50 mg/ m2 infusion for paediatric patients > 3 months of age (using a 70-mg vial) 1.
28 Priprava infuzije 50 mg/ m2 za pediatrične bolnike, stare > 3 mesece (z uporabo 70- mg viale) 1.
Aseptically add 10.5 ml of 0.9% Sodium Chloride Injection, Sterile Water for Injection or Bacteriostatic Water for Injection with methylparaben and propylparaben. a This reconstituted
Aseptično dodajte 10, 5 ml 0, 9% raztopine natrijevega klorida za injekcije, sterilne vode za injekcije ali bakteriostatične vode za injekcije z metilparabenom in propilparabenom. a Pripravljeno raztopino lahko shranite do 1 uro pri temperaturi ≤ 25 °C. b Končna koncentracija kaspofungina v viali bo tako 7, 2 mg/ ml.
CANCIDAS is formulated to provide the full labeled vial dose (70 mg) when 10 ml is withdrawn from the vial.
Zdravilo CANCIDAS je pripravljeno tako, da zagotavlja polni na viali označeni odmerek (70 mg), če iz viale potegnete 10 ml.
29 ANNEX II
29 DODATEK II
MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE
IMETNIK( I) DOVOLJENJA ZA IZDELAVO ZDRAVILA, ODGOVOREN ZA SPROŠČANJE SERIJE
Box 581, 2003 PC Haarlem, The Netherlands
Merck Sharp & Dohme BV, Waarderweg 39, PP 581, 2003 PC Haarlem, Nizozemska
Manufacturing Authorisation issued on 21 March 2001 by the Ministry of Health, Welfare and Sport, the Public Health Supervisory Service, Inspectorate of Health Care, P. O.
Dovoljenje za izdelavo zdravila je 21. marca 2001 izdalo Ministrstvo za zdravje, socialo in šport, Zdravstvena nadzorna služba, Inšpektorat za varovanje zdravja, PP 16119, 2500 B. C.
Box 16119, 2500 B. C.
Haag, Nizozemska
PSUR:
Periodično poročilo o varnosti zdravila (PSUR):
The marketing Authorisation holder will continue to submit periodic safety update reports on a 2-year cycle.
Imetnik dovoljenja za promet bo nadaljeval s predajo periodičnih poročil o varnosti zdravila na 2 leti.
31 ANNEX III
31 DODATEK III
CANCIDAS 50 mg powder for concentrate for solution for infusion Caspofungin (as acetate)
CANCIDAS 50 mg prašek za koncentrat za raztopino za infundiranje kaspofungin (v obliki acetata)
50 mg caspofungin (as acetate).
Ena viala vsebuje 50 mg kaspofungina (v obliki acetata).
SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE REACH AND SIGHT OF CHILDREN
POSEBNO OPOZORILO O SHRANJEVANJU ZDRAVILA ZUNAJ POGLEDA IN DOSEGA OTROK
SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE
POSEBNI VARNOSTNI UKREPI ZA ZA ODSTRANJEVANJE NEUPORABLJENIH ZDRAVIL ALI IZ NJIH NASTALIH ODPADNIH SNOVI, KADAR SO POTREBNI
CANCIDAS 50 mg powder for concentrate for solution for infusion Caspofungin (as acetate) Intravenous use
CANCIDAS 50 mg prašek za koncentrat za raztopino za infundiranje kaspofungin (v obliki acetata) Intravenska uporaba
36 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
36 PODATKI NA ZUNANJI OVOJNINI ALI STIČNI OZ.
CANCIDAS 70 mg powder for concentrate for solution for infusion Caspofungin (as acetate)
CANCIDAS 70 mg prašek za koncentrat za raztopino za infundiranje kaspofungin (v obliki acetata)
70 mg caspofungin (as acetate).
Ena viala vsebuje 70 mg kaspofungina (v obliki acetata).
MARKETING AUTHORISATION NUMBER(S)
ŠTEVILKA( E) DOVOLJENJA( DOVOLJENJ) ZA PROMET Z ZDRAVILOM
38 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
38 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
CANCIDAS 70 mg powder for concentrate for solution for infusion Caspofungin (as acetate) Intravenous use
Intravenska uporaba
40 PACKAGE LEAFLET:
40 NAVODILO ZA UPORABO
Read all of this leaflet carefully before you or your child start taking this medicine. • Keep this leaflet.
Pred uporabo natančno preberite navodilo! • Navodilo shranite.
Do not pass it on to others.
Morda ga boste želeli ponovno prebrati. • Če imate dodatna vprašanja, se posvetujte z zdravnikom ali s farmacevtom. • Zdravilo je bilo predpisano vam osebno ali vašemu otroku in ga ne smete dajati drugim.
What CANCIDAS is and what it is used for 2.
Kaj je zdravilo CANCIDAS in za kaj ga uporabljamo 2.
Before you take CANCIDAS 3.
Kaj morate vedeti, preden boste vzeli zdravilo CANCIDAS 3.
How to take CANCIDAS 4.
Kako jemati zdravilo CANCIDAS 4.
How to store CANCIDAS 6.
Shranjevanje zdravila CANCIDAS 6.
WHAT CANCIDAS IS AND WHAT IT IS USED FOR
KAJ JE ZDRAVILO CANCIDAS IN ZA KAJ GA UPORABLJAMO
CANCIDAS is an antifungal medicine that interferes with the production of a component (glucan polysaccharide) of the fungal cell wall that is necessary if the fungus is to continue living and growing.
CANCIDAS je protiglivično zdravilo, ki preprečuje nastajanje ene od sestavin celične stene gliv (glukan polisaharida), ki je potrebna, da gliva lahko živi in raste.
Fungal cells exposed to CANCIDAS have incomplete or defective cell walls, making them fragile and unable to grow.
Celice gliv, ki so izpostavljene zdravilu CANCIDAS, imajo nepopolne ali okvarjene celične stene, zaradi česar so krhke in ne morejo rasti.
CANCIDAS may have been prescribed to treat a serious fungal infection called invasive candidiasis.
Zdravnik vam je CANCIDAS morda predpisal za zdravljenje resne glivične okužbe, ki jo imenujemo invazivna kandidiaza.
The infection is caused by fungal (yeast) cells called Candida.
Povzročajo jo glive, imenovane Candida.
These yeast cells are normally found in the digestive tract, and do not cause an infection unless they enter the bloodstream (in which case the infection is referred to as candidaemia) or other tissues or organs, such as the lining of the abdomen (peritonitis), the heart, the kidneys, the liver, bones, muscles, joints, spleen, or eyes.
Te glive so ponavadi prisotne v prebavilih in ne povzročijo okužbe, če ne pridejo v kri (v tem primeru okužbo imenujemo kandidemija) ali v druga tkiva ali organe, npr. potrebušnico (peritonitis), srce, ledvice, jetra, kosti, mišice, sklepe, vranico ali oči.
Persons at high risk for invasive candidiasis include surgical patients and those whose immune systems are deficient.
Med tistimi, ki jih invazivna kandidiaza zelo ogroža, so bolniki po kirurškem posegu in bolniki z oslabelim imunski m sistemom.
Fever and chills that do not respond to antibacterial therapy are the most common symptoms of this type of infection.
Najpogostejša simptoma takšne okužbe sta zvišana telesna temperatura in mrzlica, ki se ne odzoveta na protibakterijsko zdravljenje.
Alternatively, your doctor may have prescribed CANCIDAS to treat a fungal infection in your nose, nasal sinuses, or lungs because other antifungal treatments have not been working as well as expected or because the other antifungal treatments are causing side effects.
Mogoče je tudi, da vam je zdravnik CANCIDAS predpisal za zdravljenje glivične okužbe v nosu, obnosnih votlinah ali pljučih, ker druga protiglivična zdravljenja niso bila tako učinkovita, kot so pričakovali, ali so povzročala neželene učinke.
This infection is caused by organisms called Aspergillus.
Takšno okužbo povzročajo organizmi, imenovani Aspergillus.
Aspergillus fungal infections begin in the respiratory system (in the nose, sinuses, or lungs) because the spores of the fungus are found in the air we breathe every day.
Glivične okužbe z vrsto Aspergillus se začnejo v dihalih (nosu, obnosnih votlinah ali pljučih), ker se glivične spore nahajajo v zraku, ki ga vsakodnevno vdihavamo.
This infection is named invasive aspergillosis.
To okužbo imenujemo invazivna aspergiloza.