natgillin/translations-raw huggingface dataset:
Ebixa orale dråber, opløsning er en klar, farveløs til let gullig opløsning.
Ebixa oral drops, solution is presented as a clear, colourless to light yellowish solution.
Ebixa orale dråber, opløsning fås i flasker med 20 g, 50 g, 100 g eller 10 x 50 g.
74 Ebixa oral drops, solution is available in bottles of 20 g, 50 g, 100 g or 10 x 50 g.
76 Eesti Österreich H.
Eesti H.
77 Latvija H.
Latvija H.
78 INDLÆGSSEDDEL:
77 PACKAGE LEAFLET:
Ebixa 5 mg, filmovertrukne tabletter Ebixa 10 mg, filmovertrukne tabletter Ebixa 15 mg, filmovertrukne tabletter Ebixa 20 mg, filmovertrukne tabletter Memantinhydrochlorid
Ebixa 5 mg film-coated tablets Ebixa 10 mg film-coated tablets Ebixa 15 mg film-coated tablets Ebixa 20 mg film-coated tablets Memantine hydrochloride
Oversigt over indlægssedlen
In this leaflet
79 I disse situationer bør behandlingen overvåges nøje, og den kliniske gavn af Ebixa skal regelmæssigt vurderes af Deres læge.
78 In these situations the treatment should be carefully supervised, and the clinical benefit of Ebixa reassessed by your doctor on a regular basis.
Hvis De har nedsat nyrefunktion (nyreproblemer), bør Deres læge nøje overvåge Deres nyrefunktion og om nødvendigt tilpasse memantin- dosen derefter.
If you suffer from renal impairment (kidney problems) your doctor should closely monitor your kidney function and if necessary adapt the memantine doses accordingly.
80 Vigtig information om nogle af de øvrige indholdsstoffer i Ebixa
Important information about some of the ingredients of Ebixa
Denne medicin indeholder laktose.
79 Ebixa 10 mg film-coated tablets contain lactose.
Tag én 5 mg tablet dagligt (hvid til grålighvid, oval- aflang) i 7 dage.
Take one 5 mg tablet once a day (white to off-white, oval-oblong) for 7 days.
Tag én 10 mg tablet dagligt (hvid til grålighvid, indsnævrende mod midten, bikonveks med delekærv på begge sider) i 7 dage.
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.
Tag én 15 mg tablet dagligt (gråligorange, oval- aflang) i 7 dage.
Take one 15 mg tablet once a day (grey-orange, oval-oblong film) for 7 days.
Tag én 20 mg tablet dagligt (gråligrød, oval- aflang) i 7 dage.
Take one 20 mg tablet per day (grey-red, oval-oblong film) for 7 days.
De bør tage tabletterne regelmæssigt hver dag på samme tidspunkt af dagen for at opnå størst mulig virkning af tabletterne. Tabletterne bør synkes sammen med noget vand.
The tablets should be swallowed with some water.
81 Behandlingens varighed
80 Duration of treatment
Ikke kendt (hyppighed kan ikke estimeres ud fra forhåndenværende data): • Betændelse i bugspytkirtlen og psykotiske reaktioner
Not known (frequency cannot be estimated from the available data): • Inflammation of the pancreas and psychotic reactions
82 Spørg på apoteket, hvordan De skal aflevere medicinrester.
81 Medicines should not be disposed of via wastewater or household waste.
Hver tablet indeholder 5/ 10/ 15/ 20 mg memantinhydrochlorid (svarende til 4, 15/ 8, 31/ 12, 46/ 16, 62 mg memantin).
Each tablet contains 5/ 10/ 15/ 20 mg of memantine hydrochloride equivalent to 4.15/ 8.31/ 12.46/ 16.62 mg memantine.
Øvrige indholdsstoffer for Ebixa 5/ 15 og 20 mg filmovertrukne tabletter er mikrokrystallinsk cellulose, croscarmellosenatrium, kolloid vandfri silica, magnesiumstearat, som alle findes i tablettens kerne, og hypromellose, macrogol 400, titandioxid (E 171) og desuden for Ebixa 15 mg and Ebixa 20 mg filmovertrukne tabletter er gul og rød jernoxid (E 172), som alle findes i tablettens overtræk.
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.
Øvrige indholdsstoffer for Ebixa 10 mg filmovertrukne tabletter er laktosemonohydrat, mikrokrystallinsk cellulose, kolloid vandfri silica, talkum og magnesiumstearat, som alle findes i tablettens kerne, og metakrylsyre – etylakrylatkopolymer (1: 1), natriumlaurylsulfat, polysorbat 80, talkum, triacetin og simetikonemulsion, som alle findes i tablettens overtræk.
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.
Ebixa 5 mg filmovertrukne tabletter er hvide til grålighvide, ovale- aflange tabletter præget med ” 5 ” på den ene side og ” MEM ” på den anden side.
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 10 mg filmovertrukne tabletter er hvide til grålighvide, aflange og indsnævrende mod midten, bikonvekse med delekærv på begge sider.
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 15 mg filmovertrukne tabletter er orange til gråligorange, ovale- aflange tabletter præget med ” 15 ” på den ene side og ” MEM ” på den anden side.
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 20 mg filmovertrukne tabletter er svagt røde til gråligrøde, ovale- aflange tabletter præget med ” 20 ” på den ene side og ” MEM ” på den anden sidet.
One treatment initiation pack contains 28 tablets in 4 blisters with 7 tablets of Ebixa 5 mg, 7 tablets of Ebixa 10 mg, 7 tablets of Ebixa 15 mg and 7 tablets of Ebixa 20 mg.
Lundbeck A/ S Ottiliavej 9 DK- 2500 Valby Danmark.
Lundbeck A/ S Ottiliavej 9 DK-2500 Valby Denmark.
83 Česká republika Lundbeck Česká republika s. r. o.
82 Č eská republika Lundbeck Č eská republika s. r. o.
3A, 2nd floor Sector 1 Bucuresti 013704- RO Tel: +40 21319 88 26
3A, 2nd floor Sector 1 Bucuresti 013704- RO Tel: +40 21319 88 26
Ireland Lundbeck (Ireland) Limited 7 Riverwalk Citywest Business Campus IRL- Dublin 24 Tel: +353 1 468 9800
Ireland Lundbeck (Ireland) Limited 7 Riverwalk Citywest Business Campus IRL - Dublin 24 Tel: +353 1 468 9800
84 Ísland Lundbeck Export A/ S, útibú á Íslandi Ármúla 1 IS- 108 Reykjavík Tel: +354 414 7070
83 Ísland Lundbeck Export A/ S, útibú á Íslandi Ármúla 1 IS-108 Reykjavík Tel: +354 414 7070
85 INDLÆGSSEDDEL:
84 PACKAGE LEAFLET:
86 Hvis De har nedsat nyrefunktion (nyreproblemer), bør Deres læge nøje overvåge Deres nyrefunktion og om nødvendigt tilpasse memantin- dosen derefter.
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.
Deres læge kan i så fald være nødt til at justere Deres medicindosis.
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.
87 Tag altid Ebixa nøjagtigt efter lægens anvisning.
Always take Ebixa exactly as your doctor has told you.
Den anbefalede dosis af Ebixa til voksne og til ældre patienter er 20 mg én gang om dagen.
The recommended dose of Ebixa for adults and elderly patients is 20 mg once a day.
Den normale startdosis er en Ebixa 5 mg filmovertrukket tablet én gang om dagen.
At the beginning of treatment you will start by using Ebixa 5 mg film-coated tablets once a day.
Ebixa bør indtages gennem munden én gang pr. dag.
Ebixa should be administered orally once a day.
Ikke almindelige (påvirker 1- 10 ud af 1. 000 patienter):
Common (affects 1 to 10 users in 100):
88
87
Træthed, svampeinfektioner, forvirring, hallucinationer, opkastning, unormal gang,
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)
hjertesvigt og blodprop i en blodåre (vene)
Very Rare (affects less than 1 user in 10,000): • Seizures
Hver filmovertrukket tablet indeholder 20 mg memantinhydrochlorid (svarende til 16, 62 mg memantin).
Each film-coated tablet contains 20 mg memantine hydrochloride equivalent to 16.62 mg memantine.
Mikrokrystallinsk cellulose, croscarmellosenatrium, kolloid vandfri silica, magnesiumstearat, som alle findes i tablettens kerne, og hypromellose, macrogol 400, titandioxid (E 171), gul og rød jernoxid (E 172), som alle findes i tablettens overtræk.
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.
Ebixa 20 mg filmovertrukne tabletter er svagt røde til gråligrøde, ovale- aflange tabletter præget med ” 20 ” på den ene side og ” MEM ” på den anden side.
Ebixa film-coated tablets are presented as pale red to grey-red, oval-oblong film-coated tablets with imprint ‘20’ on one side and imprint ‘MEM’ on the other side.
Ebixa filmovertrukne tabletter fås i blisterpakninger med 14 tabletter, 28 tabletter, 42 tabletter, 49 x 1 tabletter, 56 tabletter, 56 x 1 tabletter, 70 tabletter, 84 tabletter, 98 tabletter, 98 x 1 tabletter, 100 x 1 tabletter, 112 tabletter eller 840 (20 x 42) tabletter.
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.
Lundbeck A/ S Ottiliavej 9
Lundbeck A/S Ottiliavej 9 DK-2500 Valby Denmark.
Montevideo utca 3/ B H- 1037 Budapest Tel: +36 1 4369980
Montevideo utca 3/B H-1037 Budapest Tel: +36 1 4369980
91 Denne indlægsseddel blev senest godkendt
91
Hvad er ECALTA?
What is ECALTA?
ECALTA leveres som et pulver og en solvens, som blandes til et koncentrat, der fortyndes til en væske til infusion (drop i en vene).
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).
Hvad anvendes ECALTA til?
What is ECALTA used for?
"Invasiv" betyder, at svampen har spredt sig til blodet.
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.
ECALTA anvendes kun til voksne, som ikke er neutropene (som ikke har et lavt niveau af neutrofiler, der er en type hvide blodlegemer).
ECALTA is only used in adults who are not neutropenic (who do not have low levels of neutrophils, a type of white blood cell).
Hvordan anvendes ECALTA?
How is ECALTA used?
Behandlingen med ECALTA skal indledes af en læge med erfaring i behandling af invasive svampeinfektioner.
Treatment with ECALTA should be initiated by a doctor who has experience in the management of invasive fungal infections.
ECALTA indgives med en initialdosis på 200 mg på dag 1, efterfulgt af 100 mg dagligt fra dag 2.
ECALTA is given as an initial dose of 200 mg on day one, followed by 100 mg each day from day two.
Dette svarer til ca.
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.
3 timer for den første infusion og 1, 5 time for de efterfølgende infusioner.
The duration of treatment depends on how the patient responds.
Generelt bør behandlingen fortsættes i mindst to uger efter det sidste fund af svamp i patientens blod.
In general, treatment should continue for at least two weeks after the last time that fungus is found in the patient ’ s blood.
Hvordan virker ECALTA?
How does ECALTA work?
Det aktive stof i ECALTA, anidulafungin, er et svampedræbende middel, der hører til echinocandin - gruppen.
The active substance in ECALTA, anidulafungin, is an antifungal medicine, which belongs to the group ‘ echinocandins’.
Uden denne komponent kan svampen ikke holde sig i live og vokse.
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.
Svampeceller, som behandles med ECALTA, har ufuldstændige eller defekte cellevægge, hvilket gør dem skrøbelige og ude af stand til at vokse.
Fungal cells treated with ECALTA have incomplete or defective cell walls, making them fragile and unable to grow.
Listen over svampe, som ECALTA virker mod, fremgår af produktresuméet (også en del af denne EPAR).
The list of fungi against which ECALTA is active can be found in the Summary of Product Characteristics (also part of the EPAR).
Hvordan blev ECALTA undersøgt?
How has ECALTA been studied?
Virkningerne af ECALTA blev først afprøvet i forsøgsmodeller, inden de blev undersøgt hos mennesker.
The effects of ECALTA were first tested in experimental models before being studied in humans.
ECALTA blev undersøgt i en hovedundersøgelse med 261 patienter med invasiv candidiasis.
ECALTA has been studied in one main study involving 261 patients with invasive candidiasis.
Virkningen af ECALTA blev sammenlignet med virkningen af fluconazol (et andet svampedræbende 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
The main measure of effectiveness 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
Begge lægemidler blev indgivet ved infusion i mellem 14 og 42 dage.
(44-20) 74 18 84 00 Fax (44-20) 74 18 84 16 E-mail: mail@emea. europa. eu http: / /www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged was the proportion of patients who had responded to treatment at the end of the treatment.
Virkningen blev hovedsagelig bedømt på den andel af patienterne, som havde responderet på behandlingen ved behandlingens afslutning. ” Respons ” blev defineret som en signifikant eller fuldstændig symptomforbedring uden behov for yderligere svampedræbende behandling og ingen Candida i de prøver, som blev taget hos patienten.
A response was defined as a significant or complete improvement of symptoms, with no need for further antifungal treatment and no Candida found in the specimens taken from the patient.
Hvilken fordel viser undersøgelserne, at der er ved ECALTA?
What benefit has ECALTA shown during the studies?
ECALTA var mere effektivt end fluconazol til behandling af invasiv candidiasis.
ECALTA was more effective than fluconazole in treating invasive candidiasis.
Ved afslutningen af den intravenøse behandling havde 96 (76%) af de 127 patienter, som fik ECALTA, responderet på behandlingen, mod 71 (60%) af de 118, som fik fluconazol.
At the end of intravenous therapy, 96 (76%) of the 127 patients receiving ECALTA had responded to treatment, compared with 71 (60%) of the 118 receiving fluconazole.
Hvilken risiko er der forbundet med ECALTA?
What is the risk associated with ECALTA?
De mest almindelige bivirkninger ved ECALTA (som ses hos mellem 1 og 10 patienter ud af 100) er koagulationsdefekt (problemer med blodets størkningsevne), krampeanfald, hovedpine, diarré, opkastning, kvalme, øget indhold af blodkreatinin (en markør for nyreproblemer), udslæt, pruritus (kløe), hypokaliæmi (lavt kaliumindhold i blodet), rødmen samt forhøjet indhold af alaninaminotransferase, alkalisk fosfatase, aspartataminotransferase, bilirubin og gammaglutamyltransferase i blodet (markører for leverproblemer).
The most common side effects with ECALTA (seen in between 1 and 10 patients in 100) are coagulopathy (problems with blood clotting), convulsion (fits), headache, diarrhoea, vomiting, nausea (feeling sick), increased blood creatinine levels (a marker of kidney problems), rash, pruritus (itching), hypokalaemia (low levels of potassium in the blood), flushing, and raised blood levels of alanine aminotransferase, alkaline phosphatase, aspartate aminotransferase, bilirubin and gamma- glutamyltransferase (markers of liver problems).
Den fuldstændige liste over de indberettede bivirkninger ved ECALTA fremgår af indlægssedlen.
For the full list of all side effects reported with ECALTA, see the Package Leaflet.
ECALTA må ikke anvendes til personer, som kan være overfølsomme (allergiske) over for anidulafungin eller andre af indholdsstofferne eller over for andre lægemidler af echinocandintypen.
ECALTA should not be used in people who may be hypersensitive (allergic) to anidulafungin or any of the other ingredients, or to any other medicines in the echinocandin class.
Når ECALTA er blandet til en infusionsvæske, indeholder det en alkoholmængde, der svarer til et lille glas vin eller øl.
Once made up into an infusion, ECALTA contains alcohol in an amount that is comparable to a small glass of wine or beer.
Der skal tages højde for dette i forbindelse med bestemte patienter (f. eks. gravide, alkoholikere og patienter med leversygdom).
This will need to be taken into consideration when it is given to some patients (such as pregnant women, alcoholic patients or those with liver disease).
Eftersom ECALTA kan påvirke leverfunktionen, skal patienter, som udviser tegn på leverproblemer under behandlingen, overvåges nøje.
Because ECALTA can affect liver function, patients who show signs of liver problems during treatment should be carefully monitored.
Hvorfor blev ECALTA godkendt?
Why has ECALTA been approved?
Udvalget for Humanmedicinske Lægemidler (CHMP) konkluderede, at fordelene ved ECALTA er større end risiciene, når det anvendes til behandling af voksne, ikke- neutropene patienter med invasiv candidiasis.
The Committee for Medicinal Products for Human Use (CHMP) concluded that ECALTA’ s benefits are greater than its risks in the treatment of invasive candidiasis in adult non-neutropenic patients.
Udvalget bemærkede dog, at hovedundersøgelsen med ECALTA omfattede et utilstrækkeligt antal patienter med neutropeni til at påvise lægemidlets virkning i denne gruppe.
However, the Committee noted that the main study of ECALTA included an insufficient number of patients with neutropenia to demonstrate the medicine ’ s effectiveness in this group.
Derudover bemærkede udvalget, at ECALTA hovedsageligt er blevet undersøgt hos patienter med candidæmi (Candida sp. i blodet) og kun hos et begrænset antal patienter med infektioner eller bylder i dybtliggende væv.
In addition, it noted that ECALTA has been studied mainly in patients with candidaemia (Candida sp. in the blood), and only in a limited number of patients with deep tissue infections or abscesses.
Udvalget anbefalede udstedelse af markedsføringstilladelse for ECALTA.
The Committee recommended that ECALTA be given marketing authorisation.
Andre oplysninger Europa- Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for ECALTA til Pfizer Limited den 20. september 2007.
The European Commission granted a marketing authorisation valid throughout the European Union for ECALTA to Pfizer Limited on 20 September 2007.
Den fuldstændige EPAR for ECALTA findes her.
The full EPAR for ECALTA can be found here.
EU- nummer EU/ 1/ 07/ 416/ 001
EU/ 1/ 07/ 416/ 001
Særnavn ECALTA
ECALTA
Styrke 100 mg
100 mg
Lægemiddelform Pulver og solvens til koncentrat til infusionsvæske, opløsning
Powder and solvent for concentrate for solution for infusion
Emballage Hættelag (glas)
Vial (glass)
Indhold Pulver:
Powder:
100 mg Solvens:
100 mg Solvent:
Pakningsstørrelse 1 hætteglas + 1 hætteglas
1 vial + 1 vial
ECALTA 100 mg pulver og solvens til koncentrat til infusionsvæske, opløsning.
ECALTA 100 mg powder and solvent for concentrate for solution for infusion.
Den rekonstituerede opløsning indeholder 3, 33 mg/ ml anidulafungin, og den fortyndede opløsning indeholder 0, 36 mg/ ml anidulafungin.
The reconstituted solution contains 3.33 mg/ ml anidulafungin and the diluted solution contains 0.36 mg/ ml anidulafungin.
Fructose 102, 5 mg pr. hætteglas Ethanol 6 g pr. hætteglas
Fructose 102.5 mg per vial Ethanol 6 g per vial
Hvidt til råhvidt frysetørret pulver.
White to off-white lyophilised solid.
Klar farveløs opløsning. pH i den rekonstituerede opløsning er 4, 0- 6, 0.
The reconstituted solution has a pH of 4.0 to 6.0.
Behandling af invasiv candidiasis hos voksne non- neutropene patienter.
Treatment of invasive candidiasis in adult non-neutropenic patients.
4. 4 og 5. 1).
ECALTA has been studied primarily in patients with candidaemia and only in a limited number of patients with deep tissue Candida infections or with abscess-forming disease (see section 4.4 and section 5.1).
Herefter gives 100 mg dagligt.
A single 200 mg loading dose should be administered on Day 1, followed by 100 mg daily thereafter.
Behandlingens varighed afhænger af patientens kliniske respons.
Duration of treatment should be based on the patient ’ s clinical response.
6. 6.
ECALTA should be reconstituted with the solvent to a concentration of 3.33 mg/ ml and subsequently diluted to a concentration of 0.36 mg/ ml before use according to the instructions given in section 6.6.
Det anbefales, at ECALTA administreres med en infusionshastighed, der ikke overstiger 1, 1 mg/ minut (svarende til 3, 0 ml/ minut).
It is recommended that ECALTA be administered at a rate of infusion that does not exceed 1.1 mg/ minute (equivalent to 3.0 ml/ minute).
Infusionsrelaterede reaktioner er sjældne, når infusionshastigheden ikke overstiger 1, 1 mg/ minut.
Infusion associated reactions are infrequent when the rate of anidulafungin infusion does not exceed 1.1 mg/ minute.
ECALTA bør ikke administreres som en bolusinjektion.
ECALTA should not be administered as a bolus injection.
Nedsat nyre - og leverfunktion Dosisjustering er ikke nødvendig hos patienter med mild, moderat eller svært nedsat leverfunktion.
2 No dosing adjustments are required for patients with mild, moderate, or severe hepatic impairment.
2 Dosisjustering er ikke nødvendig hos patienter med alle grader af nedsat nyrefunktion, herunder patienter i dialyse.
No dosing adjustments are required for patients with any degree of renal insufficiency, including those on dialysis.
5. 2).
ECALTA can be given without regard to the timing of haemodialysis (see section 5.2).
Behandlingsvarighed Der er utilstrækkelig dokumentation for anvendelse af doser på 100 mg i mere end 35 dage.
Duration of treatment There are insufficient data to support the 100 mg dose for longer than 35 days of treatment.
5. 2).
Other special populations No dosing adjustments are required for adult patients based on gender, weight, ethnicity, HIV positivity, or geriatric status (see section 5.2).
5. 2).
Children and adolescents ECALTA is not recommended for use in children below 18 due to insufficient data on safety and efficacy (see section 5.2).
Overfølsomhed over for det aktive stof eller over for et eller flere af hjælpestofferne.
Hypersensitivity to the active substance, or to any of the excipients.
Overfølsomhed over for andre lægemidler af echinocandin- klassen.
Hypersensitivity to other medicinal products of the echinocandin class.
Effekten af ECALTA hos neutropene patienter med candidæmi og hos patienter med Candida - infektioner i dybtliggende væv eller intraabdominal absces og peritonitis er ikke fastslået.
The efficacy of ECALTA in neutropenic patients with candidaemia and in patients with deep tissue Candida infections or intra-abdominal abscess and peritonitis has not been established.