natgillin/translations-raw huggingface dataset:
The most frequent species isolated at baseline were C. albicans (63.8% anidulafungin, 59.3% fluconazole), followed by C. glabrata (15.7%, 25.4%), C. parapsilosis (10.2%, 13.6%) and C. tropicalis (11.8%, 9.3%) - with 20, 13 and 15 isolates of the last 3 species, respectively, in the anidulafungin group.
Najpogosteje izolirane vrste na začetku študije so bile C. albicans (63, 8% anidulafungin, 59, 3% flukonazol), nato pa C. glabrata (15, 7%, 25, 4%), C. parapsilosis (10, 2%, 13, 6%) in C. tropicalis (11, 8%, 9, 3%) – od tega je bilo 20, 13 in 15 izolatov zadnjih treh naštetih vrst v skupini z anidulafunginom.
Efficacy data, both overall and by various subgroups, are presented below in Table 1.
Podatki o učinkovitosti, tako celotni kot po raznih podskupinah, so zajeti spodaj v preglednici 1.
Anidulafungin
anidulafungin
Between group difference a (95% CI)
razlika med skupinama a (95% IZ)
End of IV Therapy (1º endpoint) Candidaemia only Other sterile sitesb c
Konec intravenskega zdravljenja (primarni opazovani dogodek)
96/ 127 (75.6%) 88/ 116 (75.9%) 8/ 11 (72.7%)
96/ 127 (75, 6%) 71/ 118 (60, 2%) 15, 42 (3, 9, 27, 0) 14, 7 (2, 5, 26, 9)
71/ 118 (60.2%) 63/ 103 (61.2%) 8/ 15 (53.3%)
Samo kandidemija b
15.42 (3.9, 27.0) 14.7 (2.5, 26.9) -
88/ 116 (75, 9%) 63/ 103 (61, 2%)
Peritoneal fluid/ IA abscess Other
Druga sterilna mesta Peritonealna tekočina/ IAc absces Drugo
5/ 8 3/ 7
8/ 11 (72, 7%) 8/ 15 (53, 3%) - 6/ 8 5/ 8 2/ 3 3/ 7
C. albicansd Non-albicans speciesd
C. albicansd Vrsta ne- albicans d
Apache II score ≤ 20 Apache II score > 20
Seštevek Apache II ≤ 20 Seštevek Apache II > 20
Non-neutropenic (ANC, cells/ mm3 > 500) Neutropenic (ANC, cells/ mm3 ≤ 500) At Other Endpoints
Nenevtropenični (ANC, celic/ mm3 > 500) Nevtropenični (ANC, celic/ mm3 ≤ 500) Sekundarni opazovani dogodki
End of All Therapy 2 Week Follow-up 6 Week Follow-up a
17, 24 (2, 9, 31, 6) e Konec celotnega zdravljenja
Mortality rates in both the anidulafungin and fluconazole arms are presented below in Table 2:
Spremljanje po 2 tednih
Overall study mortality Mortality during study therapy Mortality attributed to Candida infection
Celotna umrljivost v študiji Umrljivost med raziskovanim zdravljenjem Umrljivost, pripisana okužbi s Candido
7 5.2 Pharmacokinetic properties
7 5. 2 Farmakokinetične lastnosti
General pharmacokinetic characteristics The pharmacokinetics of anidulafungin have been characterised in healthy subjects, special populations and patients.
Splošne farmakokinetične značilnosti Farmakokinetiko anidulafungina so raziskali pri zdravih osebah, posebnih populacijah in bolnikih.
A low intersubject variability in systemic exposure (coefficient of variation ~25%) was observed.
Ugotovili so majhno interindividualno variabilnost sistemske izpostavljenosti (koeficient variacije ~25%).
Distribution The pharmacokinetics of anidulafungin are characterised by a rapid distribution half-life (0.5-1 hour) and a volume of distribution, 30-50 l, which is similar to total body fluid volume.
Porazdelitev Za farmakokinetiko anidulafungina sta značilna kratek razpolovni čas porazdelitve (0, 5– 1 uro) in volumen porazdelitve od 30 do 50 l, kar je podobno celotnemu volumnu tekočine v telesu.
Anidulafungin is extensively bound (> 99%) to human plasma proteins.
Anidulafungin je v veliki meri (> 99%) vezan na beljakovine v človeški plazmi.
Therefore, no information is available about the penetration of anidulafungin into the cerebrospinal fluid (CSF) and/ or across the blood-brain barrier.
Zato ni na voljo informacij o prodiranju anidulafungina v cerebrospinalni likvor in/ ali prehajanje skozi krvno- možgansko pregrado.
Biotransformation Hepatic metabolism of anidulafungin has not been observed.
Biotransformacija Presnove anidulafungina v jetrih niso zabeležili.
Elimination The clearance of anidulafungin is about 1 l/ h.
Izločanje Očistek anidulafungina je približno 1 l/ h.
Anidulafungin has a predominant elimination half-life of approximately 24 hours that characterizes the majority of the plasma concentration-time profile, and a terminal half-life of 40-50 hours that characterises the terminal elimination phase of the profile.
Terminalni razpolovni čas od 40 do 50 ur pa opredeljuje terminalno izločevalno fazo tega profila.
Approximately 30% of the administered radioactive dose was eliminated in the faeces over 9 days, of which less than 10% was intact drug.
Približno 30% apliciranega radioaktivnega odmerka se je izločilo v blatu v 9 dneh; manj kot 10% od tega je bilo nespremenjenega zdravila.
Less than 1% of the administered radioactive dose was excreted in the urine, indicating negligible renal clearance.
Manj kot 1% apliciranega radioaktivnega odmerka se je izločil v urinu, kar kaže na zanemarljiv ledvični očistek.
Linearity Anidulafungin displays linear pharmacokinetics across a wide range of once daily doses (15-130 mg).
Linearnost Anidulafungin ima linearno farmakokinetiko v širokem razponu odmerkov enkrat na dan (15– 130 mg).
Special populations Patients with fungal infections The pharmacokinetics of anidulafungin in patients with fungal infections are similar to those observed in healthy subjects based on population pharmacokinetic analyses.
Posebne populacije Bolniki z glivičnimi okužbami Pri bolnikih z glivičnimi okužbami je farmakokinetika anidulafungina podobna farmakokinetiki pri zdravih preiskovancih, ugotovljeni na podlagi analiz populacijske farmakokinetike.
With the 200/ 100 mg daily dose regimen at an infusion rate of 1.1 mg/ min, the steady state Cmax and trough concentrations (Cmin) could reach approximately 7 and 3 mg/ l, respectively, with an average steady state AUC of approximately 110 mg⋅ h/ l.
Z odmerno shemo 200/ 100 mg na dan in hitrostjo infundiranja 1, 1 mg/ min lahko v stanju dinamičnega ravnovesja Cmax doseže 7 mg/ l, najnižja koncentracija (Cmin) pa 3 mg/ l; povprečna AUC v stanju dinamičnega ravnovesja je približno 110 mg⋅h/ l.
Weight Although weight was identified as a source of variability in clearance in the population pharmacokinetic analysis, weight has little clinical relevance on the pharmacokinetics of anidulafungin.
Telesna masa Čeprav se je telesna masa izkazala kot vir variabilnosti očistka v analizi populacijske farmakokinetike, je njen klinični pomen za farmakokinetiko anidulafungina majhen.
8 Gender Plasma concentrations of anidulafungin in healthy men and women were similar.
8 Spol Koncentracija anidulafungina v plazmi zdravih moških in žensk je podobna.
In multiple-dose patient studies, drug clearance was slightly faster (approximately 22%) in men.
V študijah z več odmerki pri bolnikih je bil očistek zdravila pri moških nekoliko hitrejši (približno 22%).
Elderly The population pharmacokinetic analysis showed that median clearance differed slightly between the elderly group (patients ≥ 65, median CL = 1.07 l/ h) and the non-elderly group (patients < 65, median CL = 1.22 l/ h), however the range of clearance was similar.
Starejši Analiza populacijske farmakokinetike je pokazala, da se mediani očistek rahlo razlikuje med starejšo (bolniki ≥ 65 let, mediani očistek = 1, 07 l/ h) in nestarejšo skupino (bolniki < 65 let, mediani očistek = 1, 22 l/ h), toda razpon očistkov je bil podoben.
HIV positivity Dosage adjustments are not required based on HIV positivity, irrespective of concomitant anti- retroviral therapy.
HIV- pozitivnost Prilagoditev odmerjanja pri HIV- pozitivnih bolnikih ni potrebna, ne glede na sočasno protiretrovirusno zdravljenje.
Hepatic insufficiency Anidulafungin is not hepatically metabolised.
Insuficienca jeter Anidulafungin se ne presnavlja v jetrih.
Anidulafungin pharmacokinetics were examined in subjects with Child-Pugh class A, B or C hepatic insufficiency.
Farmakokinetiko anidulafungina so raziskali pri preiskovancih z insuficienco jeter razredov A, B in C po Child- Pughu.
Although a slight decrease in AUC was observed in patients with Child-Pugh C hepatic insufficiency, the decrease was within the range of population estimates noted for healthy subjects.
Čeprav so pri bolnikih z insuficienco jeter razreda C po Child- Pughu opazili rahlo zmanjšanje AUC, je bilo to zmanjšanje v območju populacijskih ocen, ugotovljenih pri zdravih osebah.
Renal insufficiency Anidulafungin has negligible renal clearance (< 1%).
Insuficienca ledvic Anidulafungin ima zanemarljiv ledvični očistek (< 1%).
Paediatric The pharmacokinetics of anidulafungin after at least 5 daily doses were investigated in 24 immunocompromised paediatric (2 to 11 years old) and adolescent (12 to 17 years old) patients with neutropenia.
Pediatrični bolniki Farmakokinetiko anidulafungina po vsaj 5 dnevnih odmerkih so raziskali pri 24 imunsko oslabelih, nevtropeničnih otrocih (starost od 2 do 11 let) in mladostnikih (od 12 do 17 let).
Systemic exposure following daily maintenance dose of 0.75 and 1.5 mg/ kg/ day in this population were comparable to those observed in adults following 50 and 100 mg/ day, respectively.
100 mg/ dan.
In 3 month studies, evidence of liver toxicity, including elevated enzymes and morphologic alterations, was observed in both rats and monkeys at doses 4- to 6-fold higher than the anticipated clinical therapeutic exposure.
5. 3 Predklinični podatki o varnosti
Embryo-foetal development studies were conducted with doses between 0.2- and 2-fold (rats) and between 1- and 4-fold (rabbits) the proposed therapeutic maintenance dose of 100 mg/ day.
Embrio- fetalne razvojne študije so bile opravljene z odmerki, ki so bili od 0, 2 - do 2- kratnik (podgane) oz. od 1 - do 4- kratnik (kunci) predvidenega terapevtskega vzdrževalnega odmerka 100 mg/ dan.
9 Anidulafungin did not produce any drug-related developmental toxicity in rats at the highest dose tested.
9 plodov), so se pojavili le ob največjem testiranem odmerku; ta odmerek je povzročil tudi toksične učinke pri samici materi.
Crossing of the blood-brain barrier by anidulafungin was limited in healthy rats; however, in rabbits with disseminated candidiasis, anidulafungin has been shown to cross the blood-brain barrier and reduce fungal burden in the brain.
Prehajanje anidulafungina skozi krvno- možgansko pregrado je bilo pri zdravih podganah omejeno, toda pri kuncih z diseminirano kandidozo je bilo dokazano, da anidulafungin prehaja skozi krvno- možgansko pregrado in zmanjša glivično breme v možganih.
Rats were dosed with anidulafungin at three dose levels and anesthetised within one hour using a combination of ketamine and xylazine.
Podgane so dobivale anidulafungin v treh ravneh odmerkov in so jih v teku ene ure anestezirali s kombinacijo ketamina in ksilazina.
There were no adverse reactions in the low- dose animals in the presence or absence of anaesthesia, and no infusion-related reactions in the mid- dose group in the absence of anaesthesia.
V nizkoodmerni skupini živali ni bilo neželenih reakcij ne z anestezijo ne brez nje, v srednjeodmerni skupini pa ni bilo z infundiranjem povezanih reakcij brez anestezije.
Fructose Mannitol Polysorbate 80 Tartaric acid Sodium hydroxide (for pH-adjustment) Hydrochloric acid (for pH-adjustment)
Prašek: fruktoza manitol polisorbat 80 vinska kislina natrijev hidroksid (za prilagoditev pH) klorovodikova kislina (za prilagoditev pH)
Ethanol anhydrous Water for injections
Vehikel: brezvodni etanol voda za injekcije
This medicinal product must not be mixed with other medicinal products or electrolytes except those mentioned in section 6.6.
Zdravila ne smemo mešati z drugimi zdravili ali elektroliti razen s tistimi, ki so omenjeni v poglavju 6. 6.
Powder and solvent:
Prašek in vehikel:
The reconstituted solution should be further diluted within an hour.
Rekonstituirano raztopino je treba dodatno razredčiti v roku ene ure.
Chemical and physical in-use stability of the reconstituted solution has been demonstrated for 3 hours at 25ºC and for 2 hours at 5°C.
Kemična in fizikalna stabilnost rekonstituirane raztopine med uporabo sta dokazani za 3 ure pri temperaturi 25 °C in za 2 uri pri temperaturi 5 °C.
Chemical and physical in-use stability of the infusion solution has been demonstrated for 24 hours at 25ºC.
Kemična in fizikalna stabilnost raztopine za infundiranje sta dokazani za 24 ur pri temperaturi 25 °C.
10 6.4 Special precautions for storage
6. 4 Posebna navodila za shranjevanje
For storage conditions of the reconstituted medicinal product, see section 6.3.
10 Za pogoje shranjevanja rekonstituiranega zdravila glejte poglavje 6. 3.
30 ml Type 1 glass vial with an elastomeric stopper and aluminium seal with flip-off cap.
30 ml steklena viala iz stekla tipa I z elastomernim zamaškom in aluminijsko zaporo s snemno zaporko.
30 ml of 20% (w/ w) ethanol anhydrous in water for injections in a Type 1 glass vial with an elastomeric stopper and aluminium seal with flip-off cap.
30 ml 20% (m/ m) brezvodnega etanola v vodi za injekcije v stekleni viali iz stekla tipa 1 z elastomernim zamaškom in aluminijsko zaporo s snemno zaporko.
ECALTA will be available as a box containing 1 vial of 100 mg powder and 1 vial of 30 ml solvent.
Zdravilo ECALTA je na voljo v škatli, ki vsebuje 1 vialo s 100 mg praška in 1 vialo s 30 ml vehikla.
ECALTA must be reconstituted with the solvent (20% (w/ w) ethanol anhydrous in water for injections) and subsequently diluted with ONLY 9 mg/ ml (0.9%) sodium chloride for infusion or 50 mg/ ml (5%) glucose for infusion.
Zdravilo ECALTA morate rekonstituirati z vehiklom (20% (m/ m) brezvodni etanol v vodi za injekcije) in nato razredčiti SAMO z raztopino 9 mg/ ml (0, 9%) natrijevega klorida za infundiranje ali raztopino 50 mg/ ml (5%) glukoze za infundiranje.
The compatibility of reconstituted ECALTA with intravenous substances, additives, or medicines other than 9 mg/ ml (0.9%) sodium chloride for infusion or 50 mg/ ml (5%) glucose for infusion has not been established.
Združljivost rekonstituiranega zdravila ECALTA z intravenskimi snovmi, aditivi ali zdravili razen 9 mg/ ml (0, 9%) natrijevega klorida za infundiranje ali 50 mg/ ml (5%) glukoze za infundiranje ni ugotovljena.
Reconstitution Aseptically reconstitute each vial with the solvent (20% (w/ w) ethanol anhydrous in water for injections) to provide a concentration of 3.33 mg/ ml.
Rekonstitucija Aseptično rekonstituirajte vsako vialo z vehiklom (20% (m/ m) brezvodnega etanola v vodi za injekcije), da dobite koncentracijo 3, 33 mg/ ml.
The reconstituted solution should be clear and free from visible particulates.
Rekonstituirana raztopina mora biti bistra in brez vidnih delcev.
The reconstituted solution must be further diluted within an hour and administered within 24 hours.
Rekonstituirano raztopino morate dodatno razredčiti v roku ene ure in aplicirati v 24 urah.
Dilution and infusion Aseptically transfer the contents of the reconstituted vial(s) into an intravenous bag (or bottle) containing either 9 mg/ ml (0.9%) sodium chloride for infusion or 50 mg/ ml (5%) glucose for infusion obtaining an anidulafungin concentration of 0.36 mg/ ml.
Razredčenje in infundiranje Aseptično prenesite vsebino rekonstituirane viale/ rekonstituiranih vial v intravensko vrečko (ali steklenico), ki vsebuje bodisi natrijev klorid 9 mg/ ml (0, 9%) za infundiranje bodisi glukozo 50 mg/ ml (5%) za infundiranje, da boste dobili koncentracijo anidulafungina 0, 36 mg/ ml.
Total
Celotna
Infusion
Hitrost
Total infusion
škatlic
Infusion solution
rekonstituirana
Rate of
količina za
of boxes
raztopine za
reconstituted volume
infundiranja
volume A volume
količina
concentration
infundiranje
30 ml (1 box)
30 ml
A
(1 škatlica) A
Either 9 mg/ ml (0.9%) sodium chloride for infusion or 50 mg/ ml (5%) glucose for infusion.
Bodisi natrijev klorid 9 mg/ ml (0, 9%) za infundiranje bodisi glukoza 50 mg/ ml (5%) za infundiranje.
Parenteral medicinal products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
Parenteralna zdravila je treba pred uporabo pregledati, da ne vsebujejo delcev in niso obarvana, kadarkoli raztopina in vsebnik dopuščata takšen pregled.
11 7 MARKETING AUTHORISATION HOLDER
IMETNIK DOVOLJENJA ZA PROMET
Pfizer Limited, Ramsgate Road, Sandwich, Kent, CT13 9NJ, United Kingdom.
Pfizer Limited, Ramsgate Road, Sandwich, Kent, CT13 9NJ, Velika Britanija
20 September 2007
20 september 2007
Rijksweg 12 BE-2870 Puurs Belgium
Rijksweg 12 BE- 2870 Puurs Belgija
Pharmacovigilance system The MAH must ensure that the system of pharmacovigilance, as described in version 1.1 (8 November 2007 and included in variation EMEA/ H/ C/ 788/ II/ 06) presented in Module 1.8.1. of the Marketing Authorisation Application, is in place and functioning before and whilst the product is on the market.
Sistem farmakovigilance Imetnik dovoljenja za promet z zdravilom mora pred prihodom zdravila na trg in dokler bo zdravilo na trgu in v uporabi zagotoviti vzpostavitev in delovanje sistema farmakovigilance, kot je opisan v verziji 1. 1 (8. november 2007 in vključeno v spremembo EMEA/ H/ C/ 788/ II/ 06) v Modulu 1. 8. 1. vloge za pridobitev dovoljenja za promet z zdravilom.
Risk Management Plan The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in version 1.2 of the Risk Management Plan (RMP) presented in Module 1.8.2. of the Marketing Authorisation Application and any subsequent updates of the RMP agreed by the CHMP.
Načrt upravljanja tveganja Imetnik dovoljenja za promet z zdravilom se zavezuje, da bo izvajal študije in dodatne farmakovigilančne dejavnosti, ki so opisane v Farmakovigilančnem načrtu, kot je predložen v v verziji 1. 2 Načrta upravljanja tveganja v Modulu 1. 8. 2. vloge za pridobitev dovoljenja za promet z zdravilom ter skladno s kasnejšimi dopolnitvami, ki jih je potrdil Odbor za zdravila za uporabo v humani medicini (CHMP).
As per the CHMP Guideline on Risk Management Systems for medicinal products for human use, the updated RMP should be submitted at the same time as the next Periodic Safety Update Report (PSUR).
V skladu s Smernicami za sisteme upravljanja tveganja pri zdravilih za uporabo v humani medicini Odbora za zdravila za uporabo v humani medicini (CHMP) je treba dopolnjen Načrt upravljanja tveganja predložiti hkrati z naslednjim Periodičnim poročilom o varnosti zdravila (PSUR).
In addition, an updated RMP should be submitted • When new information is received that may impact on the current Safety Specification, Pharmacovigilance Plan or risk minimisation activities • Within 60 days of an important (pharmacovigilance or risk minimisation) milestone being reached • At the request of the EMEA
Dodatno je treba dopolnjen Načrt upravljanja tveganja predložiti • kadar so na voljo novi podatki, ki vplivajo na trenutno Specifikacijo varnosti, Farmakovigilančni načrt ali dejavnosti za zmanjševanje tveganja • v roku 60 dni od pomembne prelomnice (v zvezi s farmakovigilanco ali z zmanjševanjem tveganja) • na zahtevo EMEA
Outer Carton
Zunanja škatla
ECALTA 100 mg powder and solvent for concentrate for solution for infusion Anidulafungin
ECALTA 100 mg prašek in vehikel za koncentrat za raztopino za infundiranje anidulafungin
Excipients: fructose, mannitol, polysorbate 80, tartaric acid and NaOH and/ or HCl for pH adjustment.
Pomožne snovi: fruktoza, manitol, polisorbat 80, vinska kislina ter natrijev hidroksid in/ ali klorovodikova kislina za prilagoditev pH.
Solvent for concentrate for solution for infusion:
Vehikel za koncentrat za raztopino za infundiranje:
Contains ethanol anhydrous and water for injections.
Vsebuje brezvodni etanol in vodo za injekcije.
1 vial of 100 mg powder 1 vial of 30 ml solvent
1 viala s 100 mg praška 1 viala s 30 ml vehikla
Reconstitute and dilute before use – read the package leaflet before use.
Pred uporabo rekonstituirajte in razredčite – pred uporabo preberite priloženo navodilo.
EXP {MONTH – YYYY}
{MM/ LLLL}
Pfizer Ltd Ramsgate Road Sandwich KENT CT13 9NJ United-Kingdom
Pfizer Ltd Ramsgate Road Sandwich KENT CT13 9NJ Velika Britanija
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION
IME ZDRAVILA
ECALTA 100 mg powder for concentrate for solution for infusion Anidulafungin Intravenous use
ECALTA 100 mg prašek za koncentrat za raztopino za infundiranje anidulafungin Intravenska uporaba
19 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
19 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
Solvent Vial label
Nalepka na viali z vehiklom
Solvent for concentrate for solution for infusion for ECALTA Intravenous use
Vehikel za koncentrat za raztopino za infundiranje ECALTA Intravenska uporaba
What ECALTA is and what it is used for 2.
Kaj je zdravilo ECALTA in za kaj ga uporabljamo 2.
What you should know before you are treated with ECALTA 3.
Kaj morate vedeti, preden boste dobili zdravilo ECALTA 3.
How to use ECALTA 4.
Kako uporabljati zdravilo ECALTA 4.
How to store ECALTA 6.
Shranjevanje zdravila ECALTA 6.
WHAT ECALTA IS AND WHAT IT IS USED FOR
KAJ JE ZDRAVILO ECALTA IN ZA KAJ GA UPORABLJAMO
ECALTA is prescribed to treat a type of fungal infection of the blood called candidaemia.
Zdravilo ECALTA uporabljamo za zdravljenje posebne vrste glivične okužbe krvi, imenovane kandidemija.
These medicines are used to treat serious fungal infections.
Ta zdravila uporabljamo za zdravljenje resnih glivičnih okužb.
In the presence of anidulafungin, fungal cells have incomplete or defective cell walls, making them fragile or unable to grow.
Celice glivic, izpostavljene anidulafunginu, imajo nepopolno ali okvarjeno celično steno, zato so krhke in ne morejo rasti.
WHAT YOU SHOULD KNOW BEFORE YOU ARE TREATED WITH ECALTA
KAJ MORATE VEDETI, PREDEN BOSTE DOBILI ZDRAVILO ECALTA
You should not be treated with ECALTA
Zdravila ECALTA ne smete dobiti
CANCIDAS), or
- če ste alergični na (preobčutljivi za) anidulafungin, druge ehinokandine (npr. zdravilo
any of the other ingredients of ECALTA
CANCIDAS) ali katerokoli sestavino zdravila ECALTA
Take special care with ECALTA
Bodite posebno pozorni pri uporabi zdravila ECALTA
- if you develop liver problems during your treatment.
- če se vam med zdravljenjem pojavijo težave z jetri.
If this happens, your doctor may decide to
Če pride do tega, se bo vaš zdravnik morda
monitor your liver function more closely.
odločil za natančnejše spremljanje delovanja vaših jeter.
- if you are given anaesthetics during your treatment with ECALTA.
- če med zdravljenjem z zdravilom ECALTA prejmete anestetike.
Children ECALTA should not be given to patients under 18 years of age.
Otroci Zdravila ECALTA ne smejo dobiti bolniki, mlajši od 18 let.
Taking other medicines There are no known interactions with other medicines likely to be given at the same time as ECALTA (i. e., rifampicin, ciclosporin, tacrolimus, voriconazole and amphotericin B).
Jemanje drugih zdravil Medsebojno delovanje z zdravili, za katera je verjetna sočasna uporaba z zdravilom ECALTA (npr. rifampicin, ciklosporin, takrolimus, vorikonazol in amfotericin B), ni znano.
Do not start or stop any other medicines without your doctor’ s or pharmacist’ s approval.
Ne začnite in ne nehajte jemati nobenega drugega zdravila, dokler vam tega ne dovoli zdravnik ali farmacevt.
22 Pregnancy and breast-feeding The effect of ECALTA in pregnant women is not known.
22 Nosečnost in dojenje Učinek zdravila ECALTA pri nosečnicah ni znan.
Therefore Ecalta is not recommended during pregnancy.
Uporaba zdravila ECALTA med nosečnostjo ni priporočljiva.
Effective contraception should be used in women of chilbearing age.
Ženske v rodni dobi morajo uporabljati učinkovito kontracepcijo.
Ask your doctor or pharmacist for advice before taking ECALTA while breast-feeding.
Preden v obdobju dojenja uporabite zdravilo ECALTA, se posvetujte z zdravnikom ali s farmacevtom.
Driving and using machines No studies on the effect on the ability to drive and use machines have been performed.
Vpliv na sposobnost upravljanja vozil in strojev Študije o vplivu na sposobnost upravljanja vozil in strojev niso bile izvedene.
Important information about some of the ingredients of ECALTA This medicinal product contains fructose (a type of sugar).
Pomembne informacije o nekaterih sestavinah zdravila ECALTA To zdravilo vsebuje fruktozo (vrsto sladkorja).