natgillin/translations-raw huggingface dataset:
Take special care with Ebixa
Bodite posebno pozorni pri jemanju zdravila Ebixa
64 If you suffer from renal impairment (kidney problems), your doctor should closely monitor your kidney function and if necessary adapt the memantine doses accordingly.
65 V primeru, da imate ledvično okvaro (težave z ledvicami), naj vaš zdravnik skrbno nadzira delovanje ledvic in po potrebi ustrezno prilagodi odmerke memantina.
The use of medicinal products called amantadine (for the treatment of Parkinson´s disease), ketamine (a substance generally used as an anaesthetic), dextromethorphan (generally used to treat cough) and other NMDA-antagonists at the same time should be avoided.
Potrebno se je izogibati sočasni uporabi zdravil, kot so amantadin (za zdravljenje Parkinsonove bolezni), ketamin (učinkovina, ki se običajno uporablja kot anestetik), dekstrometorfan (običajno se uporablja za zdravljenje kašlja) in ostali zaviralci receptorjev NMDA.
Taking Ebixa with food and drink
Jemanje zdravila Ebixa skupaj s hrano in pijačo
You should inform your doctor if you have recently changed or intend to change your diet substantially (e. g. from normal diet to strict vegetarian diet) or if you are suffering from states of renal tubulary acidosis (RTA, an excess of acid-forming substances in the blood due to renal dysfunction (poor kidney function)) or severe infections of the urinary tract (structure that carries urine), as your doctor may need to adjust the dose of your medicine.
V teh primerih bo vaš zdravnik morda prilagodil odmerek vašega zdravila.
Important information about some of the ingredients of Ebixa
Pomembne informacije o nekaterih sestavinah zdravila Ebixa
65 This medicinal product contains lactose.
To zdravilo vsebuje laktozo.
HOW TO TAKE EBIXA
KAKO JEMATI ZDRAVILO EBIXA?
Always take Ebixa exactly as your doctor has told you.
Pri jemanju zdravila Ebixa natančno upoštevajte zdravnikova navodila.
You should check with your doctor or pharmacist if you arenot sure.
Če ste negotovi, se posvetujte z zdravnikom ali s farmacevtom.
The recommended dose of Ebixa for adults and elderly patients is 20 mg once a day.
Za odrasle in starejše je priporočeni odmerek zdravila Ebixa 20 mg enkrat dnevno.
half a 10 mg tablet
polovica 10 mg tablete
two 10 mg tablets once a day
dve 10 mg tableti enkrat dnevno
This is increased to one tablet once a day (1x10 mg) in the second week and to 1and a half tablet once a day in the third week.
V drugem tednu povišamo odmerek na eno tableto enkrat dnevno (1 x 10 mg) in v tretjem tednu na 1 tableto in pol enkrat dnevno.
From the fourth week on, the usual dose is 2 tablets once a day (1x20 mg).
Od četrtega tedna naprej je običajni odmerek 2 tableti enkrat dnevno (1 x 20 mg).
- If you take a large overdose of Ebixa, contact your doctor or get medical advice, as you may
- V primeru, da ste zaužili prevelik odmerek zdravila Ebixa, obvestite svojega zdravnika, ker
need medical attention.
boste morda potrebovali zdravniško obravnavo.
- If you find you have forgotten to take your dose of Ebixa, wait and take your next dose at the
- Če ste ugotovili, da ste pozabili vzeti predpisani odmerek zdravila Ebixa, počakajte in vzemite
66
naslednji odmerek ob običajnem času.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
67 Če imate kakršnakoli dodatna vprašanja o uporabi tega zdravila, vprašajte svojega zdravnika ali farmacevta.
Like all medicines, Ebixa can cause side effects, although not everybody gets them.
Kot vsa zdravila ima lahko tudi zdravilo Ebixa neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
Common (affects 1 to 10 users in 100): • Headache, sleepiness, constipation dizziness and high blood pressure
Pogosti (vpliv pri 1 do 10 osebah od 100): • glavobol, zaspanost, zaprtje, omotica in visok krvni tlak
Uncommon (affects 1 to 10 users in 1,000): • Tiredness, fungal infections, confusion, hallucinations, vomiting, abnormal gait, heart failure and venous blood clotting (thrombosis/ thromboembolism)
Občasni (vpliv pri 1 do 10 osebah od 1. 000): • utrujenost, glivična okužba, zmedenost, halucinacije, bruhanje, neobičajna hoja, odpoved srca in krvni strdki v venah (tromboza/ tromboembolija)
Very Rare (affects less than 1 user in 10,000): • Seizures
Zelo redki (vpliv pri manj kot 1 od 10. 000 oseb): • epileptični napadi
Not known (frequency cannot be estimated from the available data) • Inflammation of the pancreas and psychotic reactions
Neznane pogostnosti (pogostosti ni mogoče oceniti iz razpoložljivih podatkov): • vnetje trebušne slinavke in psihotične reakcije
HOW TO STORE EBIXA
SHRANJEVANJE ZDRAVILA EBIXA
Do not use Ebixa after the expiry date which is stated on the carton and the blister after EXP.
Zdravila Ebixa ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in na pretisnem omotu poleg oznake EXP.
The other ingredients are lactose monohydrate, microcrystalline cellulose, colloidal anhydrous silica, talc and magnesium stearate, all in the tablet core; and methacrylic acid - ethyl acrylate copolymer (1:1), sodium lauryl sulphate, polysorbate 80, talc, triacetin and simethicone emulsion, all in the tablet coating.
Pomožne snovi so: laktoza monohidrat, mikrokristalna celuloza, brezvoden koloidni silicijev dioksid, smukec in magnezijev stearat, vse v jedru tablete; ter metakrilna kislina in etilakrilat, kopolimer (1: 1), natrijev lavrilsulfat, polisorbat 80, smukec, triacetin in simetikonska emulzija, vse v oblogi tablete.
67 What Ebixa looks like and contents of the pack
68 Izgled zdravila Ebixa in vsebina pakiranja
Ebixa film-coated tablets are presented as white to off-white, centrally tapered oblong biconvex, film- coated tablets with a single breakline on both sides.
Ebixa filmsko obložene tablete so bele do belkaste, centralno stanjšane, podolgovate, bikonveksne, filmsko obložene tablete z razdelilno zarezo na obeh straneh.
Ebixa film-coated tablets are available in blister packs of 14 tablets, 28 tablets, 30 tablets, 42 tablets, 49 x 1 tablets, 50 tablets, 56 tablets, 56 x 1 tablets, 70 tablets, 84 tablets, 98 tablets, 98 x 1 tablets, 100 tablets, 100 x 1, 112 tablets, 980 (10 x 98) tablets or 1000 (20 x 50) tablets.
Ebixa tablete se nahajajo v pretisnih omotih v škatlicah s 14 tabletami, 28 tabletami, 30 tabletami, 42 tabletami, 49 x 1 tableto, 50 tabletami, 56 tabletami, 56 x 1 tableto, 70 tabletami, 84 tabletami, 98 tabletami, 98 x 1 tableto, 100 tabletami, 100 x 1 tableto, 112 tabletami, 980 tabletami (10 x 98) ali 1000 (20 x 50) tabletami.
Marketing Authorisation Holder and Manufacturer
Imetnik dovoljenja za promet z zdravilom:
Lundbeck A/ S Ottiliavej 9 DK-2500 Valby Denmark.
Lundbeck A/ S, Ottiliavej 9, DK- 2500 Valby, Danska
68 Eesti Österreich H.
69 Eesti Österreich H.
România Lundbeck Export A/ S, Reprezentanta din Romania Bd.
Romania Lundbeck Export A/ S, Reprezentanta din Romania Bd.
69 Latvija H.
70 Latvija H.
INFORMATION FOR THE USER
71 NAVODILO ZA UPORABO
BEFORE YOU TAKE EBIXA
KAJ MORATE VEDETI, PREDEN BOSTE VZELI ZDRAVILO EBIXA
- if you are allergic (hypersensitive) to memantine hydrochloride or any of the other ingredients
- če ste alergični na (preobčutljivi za) memantinijev klorid ali katerokoli sestavino zdravila Ebixa,
of Ebixa oral drops (see section 6).
peroralnih kapljic (glejte poglavje 6).
71 If you suffer from renal impairment (kidney problems), your doctor should closely monitor your kidney function and if necessary adapt the memantine doses accordingly.
72 V primeru, da imate ledvično okvaro (težave z ledvicami), naj vaš zdravnik skrbno nadzira delovanje ledvic in po potrebi ustrezno prilagodi odmerke memantina.
The use of medicinal products called amantadine (for the treatment of Parkinson´s disease), ketamine (a substance generally used as an anaesthetic), dextromethorphan (generally used to treat cough) and other NMDA-antagonists at the same time should be avoided.
Potrebno se je izogibati sočasni uporabi zdravil, kot so amantadin (za zdravljenje Parkinsonove bolezni), ketamin (učinkovina,, ki se običajno uporablja kot anestetik), dekstrometorfan (običajno se uporablja za zdravljenje kašlja) in ostali zaviralci receptorjev NMDA.
72 Furthermore, this medicine contains potassium, less than 1 mmol (39 mg) per dose, i. e. essentially potassium-free.
73 Zdravilo vsebuje manj kot 1 mmol (39 mg) kalija na odmerek, kar v bistvu pomeni » brez kalija «.
20 drops
Za odrasle in starejše je priporočeni odmerek zdravila Ebixa 20 mg enkrat dnevno.
This is increased to 20 drops once a day (1x10 mg) in the second week and to 30 drops once a day taken in the third week.
V drugem tednu povišamo odmerek na 20 kapljic enkrat dnevno (1 x 10 mg) in v tretjem tednu na 30 kapljic enkrat dnevno.
From the fourth week on, the recommended dose is 40 drops once a day (1x20 mg).
Od četrtega tedna naprej je priporočeni odmerek 40 kapljic enkrat dnevno (1 x 20 mg).
- If you take a large overdose of Ebixa, contact your doctor or get medical advice, as you may need
- V primeru, da ste zaužili prevelik odmerek zdravila Ebixa, obvestite svojega zdravnika ali se
medical attention.
obrnite po nasvet na zdravstveno službo, ker boste morda potrebovali zdravniško obravnavo.
73 If you have any further questions on the use of this product, ask your doctor or pharmacist.
74 Če imate kakršnakoli dodatna vprašanja o uporabi tega zdravila, vprašajte svojega zdravnika ali farmacevta.
Like all medicines, Ebixa can cause side effects, although not everybody gets them.
Kot vsa zdravila, ima lahko tudi zdravilo Ebixa neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
Common (affects 1 to 10 users in 100): • Headache, sleepiness, constipation, dizziness and high blood pressure
Pogosti (vpliv pri 1 do 10 osebah od 100): • glavobol, zaspanost, zaprtje, omotica in visok krvni pritisk
Uncommon (affects 1 to 10 users in 1,000): • Tiredness, fungal infections, confusion, hallucinations, vomiting, abnormal gait, heart failure and venous blood clotting (thrombosis/ thromboembolism)
Občasni (vpliv prij 1 do 10 osebah od 1. 000): • utrujenost, glivična okužba, zmedenost, halucinacije, bruhanje, neobičajna hoja, odpoved srca in krvni strdki v venah (tromboza/ tromboembolija)
Not known (frequency cannot be estimated from the available data) • Inflammation of the pancreas and psychotic reactions
Neznana (pogostosti ni mogoče oceniti iz razpoložljivih podatkov): • vnetje trebušne slinavke in psihotične reakcije
Do not use Ebixa after the expiry date which is stated on the carton and the bottle label after EXP.
Shranjujete pri temperaturi do 30 oC.
Each one gram of oral drops, solution contains 10 mg of memantine hydrochloride (equivalent to 8.31 mg memantine).
Vsak gram peroralnih kapljic, raztopine vsebuje 10 mg memantinijevega klorida (kar ustreza 8, 31 mg memantina),
The other ingredients are potassium sorbate, sorbitol E420 and purified water.
Pomožne snovi so: kalijev sorbat, sorbitol E420 in prečiščena voda.
What Ebixa looks like and contents of the pack
75 Izgled zdravila Ebixa in vsebina pakiranja
Ebixa oral drops, solution is presented as a clear, colourless to light yellowish solution.
Ebixa peroralne kapljice, raztopina so prozorna, brezbarvna do svetlo rumenkasta raztopina.
74 Ebixa oral drops, solution is available in bottles of 20 g, 50 g, 100 g or 10 x 50 g.
Ebixa peroralne kapljice, raztopina je na voljo v stekleničkah po 20 g, 50 g, 100 g ali 10 x 50 g.
77 PACKAGE LEAFLET:
77 Podrobni podatki o tem zdravilu so na voljo na strani Evropske agencije za zdravila (EMEA) http: // www. emea. europa. eu
INFORMATION FOR THE USER
78 NAVODILO ZA UPORABO
78 In these situations the treatment should be carefully supervised, and the clinical benefit of Ebixa reassessed by your doctor on a regular basis.
Vaš zdravnik naj redno ocenjuje klinično korist zdravila Ebixa.
If you suffer from renal impairment (kidney problems) your doctor should closely monitor your kidney function and if necessary adapt the memantine doses accordingly.
V primeru, da imate ledvično okvaro (težave z ledvicami), naj vaš zdravnik skrbno nadzira delovanje ledvic in po potrebi ustrezno prilagodi odmerke memantina.
79 Ebixa 10 mg film-coated tablets contain lactose.
80 10 mg filmsko obložene tablete zravila Ebixa vsebujejo laktozo.
Take one 10 mg tablet once a day (white to off-white, centrally tapered oblong, biconvex, with a single breakline on both sides) for 7 days.
Vzemite po eno 10 mg tableto enkrat dnevno (bela do belkasta, centralno stanjšana, podolgovata, bikonveksna, z enojno zarezo na obeh straneh), jemljite 7 dni.
Take one 15 mg tablet once a day (grey-orange, oval-oblong film) for 7 days.
Vzemite po eno 15 mg tableto enkrat dnevno (sivo oranžna, ovalno podolgovata), jemljite 7 dni.
Take one 20 mg tablet per day (grey-red, oval-oblong film) for 7 days.
Vzemite po eno 20 mg tableto enkrat dnevno (sivo rdeča, ovalno podolgovata), jemljite 7 dni.
week 2
2. teden 3. teden
15 mg tablet
10 mg tableta 15 mg tableta
80 Duration of treatment
Trajanje zdravljenja
Continue to take Ebixa as long as it is of benefit to you.
81 Jemljite zdravilo Ebixa tako dolgo, kot vam pomaga.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Če imate kakršnakoli dodatna vprašanja o uporabi tega zdravila, vprašajte svojega zdravnika ali farmacevta.
Not known (frequency cannot be estimated from the available data): • Inflammation of the pancreas and psychotic reactions
Neznane pogostnosti (pogostosti ni mogoče oceniti iz razpoložljivih podatkov): • vnetje trebušne slinavke in psihotične reakcije
81 Medicines should not be disposed of via wastewater or household waste.
82 Zdravila ne smete odvreči v odpadne vode ali med gospodinjske odpadke.
Each tablet contains 5/ 10/ 15/ 20 mg of memantine hydrochloride equivalent to 4.15/ 8.31/ 12.46/ 16.62 mg memantine.
Vsaka filmsko obložena tableta vsebuje 5/ 10/ 15/ 20 mg memantinijevega klorida (kar ustreza 4, 15/ 8, 31/ 12, 46/ 16, 62 mg memantina).
The other ingredients for Ebixa 5/ 15 and 20 mg film-coated tablets are microcrystalline cellulose, croscarmellose sodium, colloidal anhydrous silica, magnesium stearate, all in the tablet core; and hypromellose, macrogol 400, titanium dioxide (E 171) and additional for Ebixa 15 mg and Ebixa 20 mg film-coated tablets are iron oxide yellow and red (E 172), all in the tablet coating.
Pomožne snovi zdravila Ebixa 5/ 15 in 20 mg filmsko obložene tablete so: mikrokristalna celuloza, premrežen natrijev karmelozat, brezvoden koloidni silicijev dioksid, in magnezijev stearat, vse v jedru tablete; ter hipermeloza, makrogol 400, titanov dioksid (E 171) in dodatno pri zdravilu Ebixa 15 mg in Ebixa 20 mg filmsko obloženih tabletah še rumeni in rdeči železov oksid (E 172), vse v oblogi tablete.
The other ingredients for Ebixa 10 mg film-coated tablets are lactose monohydrate, microcrystalline cellulose, colloidal anhydrous silica, talc and magnesium stearate, all in the tablet core; and methacrylic acid - ethyl acrylate copolymer (1:1), sodium lauryl sulphate, polysorbate 80, talc, triacetin and simethicone emulsion, all in the tablet coating.
Pomožne snovi za zdravilo Ebixa 10 mg filmsko obložene tablete so: laktoza monohidrat, mikrokristalna celuloza, brezvoden koloidni silicijev dioksid, smukec in magnezijev stearat, vse v jedru tablete; ter metakrilna kislina in etilakrilat, kopolimer (1: 1), natrijev lavrilsulfat, polisorbat 80, smukec, triacetin in simetikonska emulzija, vse v oblogi tablete.
Ebixa 5 mg film-coated tablets are presented as white to off-white, oval-oblong with imprint ‘ 5’ on one side and imprint ‘ MEM’ on the other side.
Ebixa 5 mg filmsko obložene tablete so bele do belkaste, ovalno podolgovate, z vtisnjeno številko "5" na eni strani in vtisnjeno besedo "MEM" na drugi strani.
Ebixa 10 mg film-coated tablets are presented as white to off-white, centrally tapered oblong biconvex, film-coated tablets with a single breakline on both sides.
Ebixa 10 mg filmsko obložene tablete so bele do belkaste obložene tablete, centralno stanjšane, podolgovate, bikonveksne, z enojno zarezo na obeh straneh.
Ebixa 15 mg film-coated tablets are presented as orange to grey-orange, oval-oblong with imprint ‘ 15’ on one side and imprint ‘ MEM’ on the other side.
Ebixa 15 mg filmsko obložene tablete so oranžne do sivo oranžne, ovalno podolgovate, z vtisnjeno številko "15" na eni strani in vtisnjeno besedo "MEM" na drugi strani.
Ebixa 20 mg film-coated tablets are presented as are pale red to grey-red, oval-oblong with imprint ‘ 20’ on one side and imprint ‘ MEM’ on the other side.
Ebixa 20 mg filmsko obložene tablete so bledo rdeče do sivo rdeče, ovalno podolgovate, z vtisnjeno številko "20" na eni strani in vtisnjeno besedo "MEM" na drugi strani.
България Lundbeck Export A/ S Representative Office EXPO 2000 Vaptzarov Blvd.
83 България Lundbeck Export A/ S Representative Office EXPO 2000 Vaptzarov Blvd.
Ireland Lundbeck (Ireland) Limited 7 Riverwalk Citywest Business Campus IRL - Dublin 24 Tel: +353 1 468 9800
84 Ireland Lundbeck (Ireland) Limited 7 Riverwalk Citywest Business Campus IRL- Dublin 24 Tel: +353 1 468 9800
INFORMATION FOR THE USER
85 NAVODILO ZA UPORABO
85 If you suffer from renal impairment (kidney problems), your doctor should closely monitor your kidney function and if necessary adapt the memantine doses accordingly.
86 V primeru, da imate ledvično okvaro (težave z ledvicami), naj vaš zdravnik skrbno nadzira delovanje ledvic in po potrebi ustrezno prilagodi odmerke memantina.
You should inform your doctor if you have recently changed or intend to change your diet substantially (e. g. from normal diet to strict vegetarian diet) or if you are suffering from states of renal tubulary acidosis (RTA, an excess of acid-forming substances in the blood due to renal dysfunction (poor kidney function))or severe infections of the urinary tract (structure that carries urine), as your doctor may need to adjust the dose of your medicine.
V teh primerih bo vaš zdravnik morda prilagodil odmerek vašega zdravila.
Dosage
87 Odmerjanje
For up-titration other tablet strengths are available.
Da bi zmanjšali nevarnost pojava neželenih učinkov, odmerek dosegate postopoma, po priporočilu sledeče sheme dnevnega odmerjanja.
Common (affects 1 to 10 users in 100):
Pogosti (vpliv pri 1 do 10 osebah od 100): • glavobol, zaspanost, zaprtje, omotica in visok krvni tlak
Uncommon (affects 1 to 10 users in 1,000): • Tiredness, fungal infections, confusion, hallucinations, vomiting, abnormal gait, heart failure and venous blood clotting (thrombosis/thromboembolism)
88 Občasni (vpliv pri 1 do 10 osebah od 1. 000): • utrujenost, glivična okužba, zmedenost, halucinacije, bruhanje, neobičajna hoja, odpoved srca in krvni strdki v venah (tromboza/ tromboembolija)
Very Rare (affects less than 1 user in 10,000): • Seizures
Zelo redki (vpliv pri kot 1 od 10. 000 oseb): • epileptični napadi
The other ingredients are microcrystalline cellulose, croscarmellose sodium, colloidal anhydrous silica, magnesium stearate, all in the tablet core; and hypromellose, macrogol 400, titanium dioxide (E 171), iron oxide yellow and red (E 172), all in the tablet coating.
Pomožne snovi so: mikrokristalna celuloza, premrežen natrijev karmelozat, brezvoden koloidni silicijev dioksid, in magnezijev stearat, vse v jedru tablete; ter hipermeloza, makrogol 400, titanov dioksid (E 171) rumeni in rdeči železov oksid (E 172), vse v oblogi tablete.
Ebixa film-coated tablets are available in blister packs of 14 tablets, 28 tablets, 42 tablets, 49 x 1 tablets, 56 tablets, 56 x 1 tablets, 70 tablets, 84 tablets, 98 tablets, 98 x 1 tablets, 100 x 1, 112 tablets or 840 (20 x 42) tablets.
Ebixa tablete se nahajajo v pretisnih omotih v škatlicah s 14 tabletami, 28 tabletami, 42 tabletami, 49 x 1 tableto, 56 tabletami, 56 x 1 tableto, 70 tabletami, 84 tabletami, 98 tabletami, 98 x 1 tableto, 100 x 1 tableto, 112 tabletami ali 840 tabletami (20 x 42).
Lundbeck A/S Ottiliavej 9 DK-2500 Valby Denmark.
Lundbeck A/ S, Ottiliavej 9, DK- 2500 Valby, Danska
România Lundbeck Export A/S, Reprezentanta din Romania Bd.
Romania Lundbeck Export A/ S, Reprezentanta din Romania Bd.
90 This leaflet was last approved in
Navodilo je bilo odobreno
Detailed information on this product is available on the website of the European Medicines Agency (EMEA) http://www.emea.europa.eu
Podrobni podatki o tem zdravilu so na voljo na strani Evropske agencije za zdravila (EMEA) http: // www. emea. europa. eu
What is ECALTA?
Kaj je zdravilo ECALTA?
ECALTA is a powder and solvent that are made up into a concentrate, which is diluted to make a solution for infusion (drip into a vein).
Zdravilo ECALTA je prašek in vehikel za pripravo koncentrata, ki se pred uporabo razredči, s čimer dobimo raztopino za infundiranje (dajanje v veno).
What is ECALTA used for?
Za kaj se zdravilo ECALTA uporablja?
ECALTA is used to treat invasive candidiasis (a type of fungal infection caused by a yeast-like fungus called Candida sp.). ‘ Invasive ’ means that the fungus has spread into the blood.
„ Invazivna “ pomeni, da se je gliva razširila v kri.
ECALTA is only used in adults who are not neutropenic (who do not have low levels of neutrophils, a type of white blood cell).
Zdravilo ECALTA se uporablja le pri odraslih, ki niso nevtropenični (ki nimajo nizke ravni nevtrofilcev, vrste belih krvničk).
How is ECALTA used?
Kako se zdravilo ECALTA uporablja?
Treatment with ECALTA should be initiated by a doctor who has experience in the management of invasive fungal infections.
Zdravljenje z zdravilom ECALTA mora uvesti zdravnik z izkušnjami pri zdravljenju invazivnih glivičnih okužb.
ECALTA is given as an initial dose of 200 mg on day one, followed by 100 mg each day from day two.
Zdravilo ECALTA se daje v začetnem odmerku 200 mg na prvi dan, ki mu sledijo odmerki po 100 mg vsak dan od drugega dne naprej.
ECALTA should only be given by infusion, at a maximum rate of 1.1 mg per minute to avoid side effects: this corresponds to about three hours for the initial infusion, and one and a half hours for the subsequent infusions.
Zdravilo ECALTA se daje samo v obliki infuzije, z največjo hitrostjo 1, 1 mg na minuto, da bi tako preprečili stranske učinke: časovno to ustreza približno trem uram za začetno infuzijo ter poldrugi uri za nadaljnje infuzije.
The duration of treatment depends on how the patient responds.
Trajanje zdravljenja je odvisno od bolnikovega odziva.
In general, treatment should continue for at least two weeks after the last time that fungus is found in the patient ’ s blood.
Navadno naj bi zdravljenje trajalo še najmanj dva tedna potem, ko so bile glive nazadnje prisotne v bolnikovi krvi.
How does ECALTA work?
Kako zdravilo ECALTA deluje?
The active substance in ECALTA, anidulafungin, is an antifungal medicine, which belongs to the group ‘ echinocandins’.
Zdravilna učinkovina zdravila ECALTA, anidulafungin, je protiglivično zdravilo, ki sodi v skupino ehinokandinov.
It works by interfering with the production of a component of the fungal cell wall called 1,3-β -D-glucan, which is necessary if the fungus is to continue living and growing.
Deluje tako, da posega v tvorbo ene od sestavin celične stene glive, imenovane 1, 3- β- D- glukan, ki je nujna, da bi gliva lahko živela in rasla.
Fungal cells treated with ECALTA have incomplete or defective cell walls, making them fragile and unable to grow.
Celice gliv, ki so izpostavljene zdravilu ECALTA, imajo nepopolne ali okvarjene celične stene, zaradi česar so krhke in ne morejo rasti.
The list of fungi against which ECALTA is active can be found in the Summary of Product Characteristics (also part of the EPAR).
Za seznam gliv, proti katerim zdravilo ECALTA učinkuje, glejte Povzetek glavnih značilnosti zdravila (ki je prav tako del EPAR).
How has ECALTA been studied?
Kako je bilo zdravilo ECALTA raziskano?
The effects of ECALTA were first tested in experimental models before being studied in humans.
Učinki zdravila ECALTA so bili najprej preizkušeni na poskusnih modelih, nato pa so jih raziskali pri ljudeh.
ECALTA has been studied in one main study involving 261 patients with invasive candidiasis.
Zdravilo ECALTA so preučevali v eni glavni študiji, v kateri je sodelovalo 261 bolnikov z invazivno kandidozo.