natgillin/translations-raw huggingface dataset:
Fortæl det altid til lægen eller på apoteket, hvis du bruger anden medicin eller har brugt det for nylig.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Pulveret er et hvidt til råhvidt pulver.
The powder is white to off-white.
I tilfælde af overdosering kan de bivirkninger, som er anført i pkt.
In case of overdose, adverse reactions may occur as mentioned in section 4.8.
Afslutning af i.v.-behandling (primære endemål) Kun candidæmi Andre sterile steder Peritonealvæske/IA
End of IV Therapy (1º endpoint) Candidaemia only Other sterile sites Peritoneal fluid/IA c abscess
MIC-breakpoint (mg/l)
MIC breakpoint (mg/L) ≤S (Susceptible) >R (Resistant)
Meget almindelige bivirkninger (det sker hos flere end 1 ud af 10 behandlede):
Very common side effects (may affect more than 1 in 10 people) are:
Anidulafungins farmakokinetik var ens blandt personer af europæisk, sort, asiatisk og latinamerikansk afstamning.
Ethnicity Anidulafungin pharmacokinetics were similar among Caucasians, Blacks, Asians, and Hispanics.
Almindelig til
Common to
Patienterne blev randomiseret til enten at få anidulafungin (200 mg intravenøs initialdosis efterfulgt af 100 mg intravenøst dagligt) eller fluconazol (800 mg intravenøs initialdosis efterfulgt af 400 mg intravenøst dagligt) og blev stratificeret ved APACHE II-score (20 og >20) og tilstedeværelse eller fravær af neutropeni.
Patients were randomised to receive either anidulafungin (200 mg intravenous loading dose followed by 100 mg intravenous daily) or fluconazole (800 mg intravenous loading dose followed by 400 mg intravenous daily), and were stratified by APACHE II score (≤20 and >20) and the presence or absence of neutropaenia.
Virkningen af ECALTA på ammende kvinder kendes ikke.
The effect of ECALTA in breast-feeding women is not known.
Ved fysiologisk temperatur og pH undergår anidulafungin en langsom kemisk nedbrydning til et peptid med åben ring, som mangler fungicid aktivitet.
Anidulafungin undergoes slow chemical degradation at physiologic temperature and pH to a ringopened peptide that lacks antifungal activity.
Alligevel tilrådes forsigtighed, når anidulafungin anvendes sammen med anæstetika.
Nevertheless, care should be taken when co-administering anidulafungin and anaesthetic agents.
En enkelt initialdosis på 200 mg bør administreres på dag 1.
A single 200 mg loading dose should be administered on Day 1, followed by 100 mg daily thereafter.
De kan finde yderligere oplysninger om ECALTA på Det Europæiske Lægemiddelagenturs hjemmesidehttp://www.ema.europa.eu/
Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.
500 celler/mm eller klassificeret af investigator som neutropene ved baseline) med mikrobiologisk bekræftet invasiv candidiasis blev vurderet i en analyse af indsamlede data fra 5 prospektive studier (1 komparativt versus caspofungin og 4 åbne, non-komparative studier).
cells/mm or classified by the investigator as neutropenic at baseline) with microbiologically confirmed invasive candidiasis was assessed in an analysis of pooled data from 5 prospective studies (1 comparative versus caspofungin and 4 open-label, non-comparative).
Du skulle ikke opleve nogle bivirkninger, når du stopper behandlingen med ECALTA.
If you stop using ECALTA You should not experience any effects from ECALTA if your doctor stops ECALTA treatment.
Egnede patienter fik enten anidulafungin (200 mg intravenøs initialdosis efterfulgt af 100 mg intravenøst dagligt) eller caspofungin (70 mg intravenøs initialdosis efterfulgt af 50 mg intravenøst dagligt) (2:1 randomisering).
Eligible patients received either anidulafungin (200 mg intravenous loading dose followed by 100 mg intravenous daily) or caspofungin (70 mg intravenous loading dose followed by 50 mg intravenous daily) (2:1 randomization).
Den succesfulde globale responsrate ved afslutning af intravenøs behandling (primært endemål) var 26/46 (56,5 %) og ved afslutning af al behandling 24/46
The successful global response rate at End of Intravenous Treatment (primary endpoint) was 26/46 (56.5%) and End of All Treatment was 24/46 (52.2%).
Infusionsvolumen
Infusion volume
Effekten af anidulafungin (200 mg intravenøs initialdosis efterfulgt af 100 mg intravenøst dagligt) hos voksne med mikrobiologisk bekræftet candidiasis i dybtliggende væv blev vurderet i en analyse af indsamlede data fra 5 prospektive studier (1 komparativt og 4 åbne studier).
The efficacy of anidulafungin (200 mg intravenous loading dose followed by 100 mg intravenous daily) in adult patients with microbiologically confirmed deep tissue candidiasis was assessed in an analysis of pooled data from 5 prospective studies (1 comparative and 4 open-label).
De hyppigst isolerede patogener ved baseline var C. tropicalis (34,8 %; 16/46), C. krusei (19,6 %; 9/46), C. parapsilosis (17,4 %; 8/46), C. albicans (15,2 %; 7/46) og C. glabrata (15,2 %; 7/46).
The most common pathogens isolated at baseline were C. tropicalis (34.8%; 16/46), C. krusei (19.6%; 9/46), C. parapsilosis (17.4%; 8/46), C. albicans (15.2%; 7/46), and C. glabrata (15.2%; 7/46).
Patienter med mikrobiologisk bekræftet candidiasis (MITT-population) og neutropeni blev identificeret i en analyse af indsamlede data fra 4 prospektive, åbne, non-komparative studier med sammenligneligt design.
Patients with microbiologically confirmed invasive candidiasis (MITT population) and neutropenia were identified in an analysis of pooled data from 4 similarly designed prospective, open-label, noncomparative studies.
Spørg lægen eller apoteket til råds, før du tager ECALTA, hvis du ammer.
Ask your doctor or pharmacist for advice before taking ECALTA while breast-feeding.
Denne indlægsseddel blev senest ændret:
This leaflet was last revised in {MM/YYYY}.
Der blev ikke rapporteret om bivirkninger.
No clinical adverse reactions were reported.
Det skal du vide, før du bliver behandlet med ECALTA
What you need to know before you use ECALTA
Anafylaktis k shock, anafylaktis k reaktion*
Anaphylacti c shock, anaphylactic reaction*
- Øvrige indholdsstoffer: Fructose, mannitol, polysorbat 80, vinsyre, natriumhydroxid (til pH-justering), saltsyre (til pHjustering)
- The other ingredients are: fructose, mannitol, polysorbate 80, tartaric acid, sodium hydroxide
Der er ikke udført specifikke vævsdistributionsstudier med anidulafungin på mennesker, hvorfor der ikke findes information vedrørende anidulafungins penetration af cerebrospinalvæsken og/eller over blod-hjernebarrieren.
Therefore, no information is available about the penetration of anidulafungin into the cerebrospinal fluid (CSF) and/or across the blood-brain barrier.
Opløsningen skal smides væk, hvis der ses partikler eller misfarvning.
After subsequent dilution, the solution is to be discarded if particulate matter or discoloration is identified.
I de 4 åbne studier var det tilladt at skifte til oral azolbehandling efter mindst 5-10 dage med anidulafungin.
In the 4 open-label studies, a switch to oral azole therapy was permitted after at least 5 to 10 days of treatment with anidulafungin.
Hyperglykæmi
Hypokalaemia Hyperglycaemia
Koncentrationen af anidulafungin i hjernen hos uinficerede voksne og nyfødte rotter efter en enkelt dosis var lav (hjerne:plasma-ratio på ca. 0,2).
The concentration of anidulafungin in the brain was low (brain to plasma ratio of approximately 0.2) in uninfected adult and neonatal rats after a single dose.
Hvert hætteglas indeholder 100 mg anidulafungin.
Each vial contains 100 mg anidulafungin.
De hyppigste infektionssteder inkluderede peritonealhulen (54,3 %; 70 ud af 129), lever og galdeveje (7,0 %; 9 ud af 129), pleurahulen (5,4 %; 7 ud af 129) og nyre (3,1 %; 4 ud af 129).
The most common sites of infection included the peritoneal cavity (54.3%; 70 of 129), hepatobiliary tract (7.0%; 9 of 129), pleural cavity (5.4%; 7 of 129) and kidney (3.1%; 4 of 129).
Kun til intravenøst brug.
For single use only.
Der er rapporteret infusionsrelaterede bivirkninger med anidulafungin i kliniske studier, herunder udslæt, pruritus (almindelig bivirkning), ansigtsrødme, hedeture, og urticaria (ikke almindelig bivirkning), som anført i skema 1 (se pkt.
Infusion-related adverse reactions have been reported with anidulafungin in clinical studies, including rash, pruritus, dyspnoea, bronchospasm, hypotension (common events), flushing, hot flush, and urticaria (uncommon events), summarized in Table 1 (see section 4.4).
Hvert hætteglas rekonstitueres med 30 ml vand til injektionsvæsker for at opnå en koncentration på 3,33 mg/ml under aseptiske forhold.
Aseptically reconstitute each vial with 30 mL water for injections to provide a concentration of 3.33 mg/mL.
Hvis du holder op med at få ECALTA
If you forgot to use ECALTA
Den succesfulde globale responsrate ved afslutningen af al behandling var 8/11 (72,7 %) for anidulafungin og 3/3 (100,0 %) for caspofungin (difference -27,3, 95 % CI -80,9; 40,3).
The successful global response rate at the End of Intravenous Treatment (primary endpoint) was 8/11 (72.7%) for anidulafungin and 3/3 (100.0%) for caspofungin (difference -27.3, 95% CI -80.9, 40.3); the successful global response rate at the End of All Treatment was 8/11 (72.7%) for anidulafungin and 3/3 (100.0%) for caspofungin (difference -27.3, 95% CI -80.9, 40.3).
De hyppigste arter isoleret ved baseline var C. albicans (63,8 % anidulafungin, 59,3 % fluconazol) efterfulgt af C. glabrata (15,7 %, 25,4 %), C. parapsilosis (10,2 %, 13,6 %) og C. tropicalis (11,8 %, 9,3 %) med henholdsvis 20, 13 og 15 isolater af de 3 sidstnævnte arter i anidulafungingruppen.
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.
Infusionsopløsningen er dokumenteret kemisk og fysisk stabil i 48 timer ved 25 ºC.
Chemical and physical in-use stability of the infusion solution has been demonstrated for 48 hours at 25ºC.
Dosis Antal hætteglas med pulver
Dose Number of vials of powder
Hvert hætteglas med pulver indeholder 100 mg anidulafungin.
Each vial of powder contains 100 mg anidulafungin.
Hvis der ses partikler eller misfarvning efter yderligere fortynding, skal opløsningen kasseres.
If either particulate matter or discolouration are identified, discard the solution.
Almindelige bivirkninger (det sker hos op til 1 ud af 10 behandlede):
Common side effects (may affect up to 1 in 10 people) are:
Den rekonstituerede opløsning er dokumenteret kemisk og fysisk stabil i 24 timer ved 25 ºC.
Chemical and physical in-use stability of the reconstituted solution has been demonstrated for 24 hours at 25ºC.
Opbevaringsbetingelser efter rekonstitution og fortynding er anført i pkt.
For storage conditions after reconstitution and dilution of the medicinal product, see section 6.3.
Hos klinisk stabile patienter var det tilladt at skifte til oral azolbehandling efter mindst 10 dages forsøgsbehandling.
In clinically stable patients, a switch to oral azole therapy was permitted after at least 10 days of study treatment.
Den rekonstituerede opløsning kan opbevares ved op til 25 ºC i op til 24 timer inden yderligere fortynding.
The reconstituted solution may be stored up to 25°C for up to 24 hours prior to further dilution.
Ikke almindelige bivirkninger (det sker hos op til 1 ud af 100 behandlede):
Uncommon side effects (may affect up to 1 in 100 people) are:
Enten 9 mg/ml (0,9%) natriumchloridinfusionsvæske eller 50 mg/ml (5%) glucoseinfusionsvæske.
Either 9 mg/mL (0.9%) sodium chloride for infusion or 50 mg/mL (5%) glucose for infusion.
Pleurahule
Urticaria
Anidulafungins farmakokinetik blev undersøgt hos forsøgspersoner med nedsat leverfunktion, Child-Pugh-klasse A, B eller C. Hos forsøgspersoner med alle grader af nedsat leverfunktion ses ingen stigning i anidulafunginkoncentrationen.
Anidulafungin pharmacokinetics were examined in subjects with Child-Pugh class A, B or C hepatic insufficiency.
Infusionsopløsning
Infusion solution
- Problemer med blodets størkning - Ansigtsrødme - Hedeture - Mavesmerter - Nældefeber - Smerter på injektionsstedet.
- Disorder of blood clotting system - Flushing - Hot flush - Stomach pain - Hives - Pain at injection site
Rotter fik anidulafungin-doser på tre dosisniveauer og anæstesi inden for 1 time.
Rats were dosed with anidulafungin at three dose levels and anaesthetised within one hour using a combination of ketamine and xylazine.
Kan opbevares uden for køleskab ved 25 ºC i op til 96 timer og pulveret kan derefter sættes tilbage på køl.
Excursions for 96 hours up to 25ºC are permitted, and the powder can be returned to refrigerated storage.
Almene symptomer og reaktioner på administration s-stedet
General Disorders and Administration Site Conditions
De hyppigst isolerede patogener fra dybtliggende vævssteder ved baseline var C. albicans (64,3 %; 83 ud af 129), C. glabrata (31,0 %; 40 ud af 129), C. tropicalis (11,6 %; 15 ud af 129) og C. krusei (5,4 %; 7 ud af 129).
The most common pathogens isolated from a deep tissue site at baseline were C. albicans (64.3%; 83 of 129), C. glabrata (31.0%; 40 of 129), C. tropicalis (11.6%; 15 of 129), and C. krusei (5.4%; 7 of 129).
Hos både rotter og aber, der fik 4-6 gange højere doser end den forventede kliniske terapeutiske dosis, sås tegn på levertoksicitet, herunder forhøjede enzymer og morfologisk ændring i studier af 3 måneders varighed.
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.
Hos klinisk stabile patienter var det tilladt at skifte til oral azolbehandling efter mindst 5-10 dages behandling med anidulafungin.
In clinically stable patients, a switch to oral azole therapy was permitted after at least 5 to 10 days of treatment with anidulafungin.
Det skal du vide, før du bliver behandlet med ECALTA Sådan bruger du ECALTA
What ECALTA is and what it is used for What you need to know before you use ECALTA How to use ECALTA
Infusionsrelaterede reaktioner er sjældne, når infusionshastigheden ikke overstiger 1,1 mg/minut (se pkt.
Infusion associated reactions are infrequent when the rate of anidulafungin infusion does not exceed 1.1 mg/min (see section 4.4).
Baseret på populationfarmakokinetiske analyser er anidulafungins farmakokinetik den samme hos patienter med svampeinfektioner som hos raske forsøgspersoner.
The pharmacokinetics of anidulafungin in patients with fungal infections are similar to those observed in healthy subjects based on population pharmacokinetic analyses.
Effekten af anidulafungin (200 mg intravenøs initialdosis efterfulgt af 100 mg intravenøst dagligt) blev vurderet hos 35 voksne neutropene patienter defineret som absolut neutrofiltal ≤ 500 celler/mm
The efficacy of anidulafungin (200 mg intravenous loading dose followed by 100 mg intravenous daily) was assessed in 35 adult neutropenic patients defined as absolute neutrophil count ≤ 500 cells/mm
Kramper, hovedpine
Convulsion, headache
ECALTA findes i en pakning med 1 hætteglas, der indeholder 100 mg pulver til koncentrat til infusionsvæske, opløsning.
ECALTA is supplied as a box containing 1 vial of 100 mg powder for concentrate for solution for infusion.
Hyppigheden ikke kendt:
Not known (frequency cannot be estimated from the available data) are:
Effekten af anidulafungin (200 mg intravenøs initialdosis efterfulgt af 100 mg intravenøst dagligt) hos voksne neutropene patienter (defineret som absolut neutrofiltal ≤ 500 celler/mm
The efficacy of anidulafungin (200 mg intravenous loading dose followed by 100 mg intravenous daily) in adult neutropenic patients (defined as absolute neutrophil count ≤ 500 cells/mm
Infusionsrelaterede bivirkninger er sjældne, hvis infusionshastigheden ikke overstiger 1,1 mg/minut (se pkt.
Infusion-related adverse events are infrequent when the rate of anidulafungin infusion does not exceed 1.1 mg/min (see section 4.8).
Skema 1.
Table 1.
Fortæl det straks til lægen eller sygeplejersken, hvis dine oprindelige symptomer kommer igen.
If your original symptoms come back, tell your doctor or another healthcare professional immediately.
Candida-art
Candida Species
Den rekonstituerede opløsning kan opbevares ved op til 25 °C i op til 24 timer.
The reconstituted solution may be stored at up to 25°C for up to 24 hours.
In vivo-aktivitet
Activity in vivo
Anidulafungin virker fungicidt over for Candida, mens det for Aspergillus' vedkommende hæmmer væksten af hyphae.
Anidulafungin has shown fungicidal activity against Candida species and activity against regions of active cell growth of the hyphae of Aspergillus fumigatus.
Immunsystem et
Immune System Disorders
Patienter med nedsat nyre- og leverfunktion
Patients with renal and hepatic impairment
Der blev ikke set påvirkning af han- og hunrotters fertilitet i studier med anidulafungin (se pkt.
For anidulafungin, there were no effects on fertility in studies conducted in male and female rats (see section 5.3).
Sådan vil du få ECALTA
How to store ECALTA
Skema over bivirkninger Organklasse Meget almindeli
Table of Adverse Reactions System Organ
Den rekonstituerede opløsning kan opbevares ved op til 25 ºC i op til 24 timer.
The reconstituted solution may be stored up to 25C for up to 24 hours.
Dosisjustering er ikke nødvendig for anidulafungin, når det anvendes samtidigt med amphotericin B eller rifampicin.
No dosage adjustment of either medicinal product is recommended when anidulafungin is co-administered with ciclosporin, voriconazole or tacrolimus, and no dosage adjustment for anidulafungin is recommended when co-administered with amphotericin B or rifampicin.
ECALTA skal rekonstitueres med vand til injektionsvæsker, og derefter må det KUN fortyndes med 9 mg/ml (0,9 %) natriumchloridinjektionsvæske eller 50 mg/ml (5 %) glucoseinfusionsvæske.
ECALTA must be reconstituted with water for injections and subsequently diluted with ONLY sodium chloride 9 mg/mL (0.9%) solution for injection or 50 mg/mL (5%) glucose for infusion.
Der er ikke foretaget forligelighedsundersøgelser med andre intravenøse substanser, additiver eller lægemidler end 9 mg/ml (0,9 %) natriumchloridinfusionsvæske eller 50 mg/ml (5 %) glucoseinfusionsvæske.
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.
Et succesfuldt globalt respons blev defineret som både klinisk og mikrobiologisk succes.
A successful global response was defined as both clinical and microbiologic success EOIVT, End of Intravenous Treatment; EOT, End of All Treatment
Indholdet i hætteglasset skal rekonstitueres med vand til injektionsvæsker, og derefter skal det fortyndes med kun 9 mg/ml (0,9 %) natriumchloridinfusionsvæske eller 50 mg/ml (5 %) glucoseinfusionsvæske.
The contents of the vial must be reconstituted with 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.
Udslæt, pruritus Urticaria
Rash, pruritus
Indholdet af det (de) rekonstituerede hætteglas overføres aseptisk til den intravenøse pose (eller flaske), der indeholder enten 9 mg/ml (0,9 %) natriumchloridinfusionsvæske eller 50 mg/ml (5%) glucoseinfusionsvæske.
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 0.77 mg/mL.
ECALTA 100 mg pulver til koncentrat til infusionsvæske, opløsning Anidulafungin
ECALTA 100 mg powder for concentrate for solution for infusion anidulafungin
ECALTA 100 mg pulver til koncentrat til infusionsvæske, opløsning anidulafungin
ECALTA 100 mg powder for concentrate for solution for infusion Anidulafungin
Lægen fastlægger behandlingens varighed og daglige dosis.
Your doctor will determine the duration of your treatment and how much ECALTA you will receive each day and will monitor your response and condition.
* Se pkt.
Lot {number}
Før behandling initieres, bør der tages prøver med henblik på svampedyrkning.
Specimens for fungal culture should be obtained prior to therapy.
- hvis du udvikler leverproblemer under behandlingen.
Your doctor may decide to monitor you - for liver function more closely if you develop liver problems during your treatment.
- Kramper (anfald) - Rødmen i ansigtet - Udslæt, kløe - Hedeturer - Nældefeber - Pludselig sammentrækning af musklerne i luftvejene, der fører til hvæsende vejrtrækning eller hoste - Vejrtrækningsbesvær
Serious side effects - tell your doctor or another healthcare professional immediately should any of the following occur: - Convulsion (seizure) - Flushing - Rash, pruritis (itching) - Hot flush - Hives - Sudden contraction of the muscles around the airways resulting in wheezing or coughing - Difficulty of breathing
I et studie med 10 raske forsøgspersoner, der fik en initialdosis på 260 mg dagligt og derefter 130 mg dagligt, sås ikke dosisbegrænsende toksicitet.
No dose limiting toxicity was observed in a study of 10 healthy subjects administered a loading dose of 260 mg followed by 130 mg daily; 3 of the 10 subjects experienced transient, asymptomatic transaminase elevations (3 x Upper Limit of Normal (ULN)).
Smerter på infusionsstedet
Infusion site pain
[Fritaget fra krav om blindeskrift]
[Justification for not including Braille accepted.]
Exp
EXP {MM/YYYY}
Leverinsufficiens
Insufficient evidence
Hos raske forsøgspersoner og patienter, der er behandlet med anidulafungin, er der set en stigning i leverenzymer.
Increased levels of hepatic enzymes have been seen in healthy subjects and patients treated with anidulafungin.
- hvis du får tegn på en allergisk reaktion såsom kløe, hvæsende vejrtrækning, skjoldet hud.
- if you are given anaesthetics during your treatment with ECALTA.for signs of an allergic reaction such as itching, wheezing, blotchy skin - for signs of an infusion-related reaction which could include a rash, hives, itching, redness, - for shortness of breath/breathing difficulties, dizziness or lightheadedness
4.8, forekomme.
* See section 4.4.
Peritonealhule
Peritoneal cavity
ECALTA 100 mg pulver til koncentrat til infusionsvæske, opløsning.
ECALTA 100 mg powder for concentrate for solution for infusion
Øvre abdominalsmerter
Abdominal pain upper
I et præ-klinisk dyreforsøg med rotter er der set eksacerbation af infusionsrelaterede reaktioner ved samtidig anvendelse af anæstetika (se pkt.
Exacerbation of infusion-related reactions by co-administration of anaesthetics has been seen in a nonclinical (rat) study (see section 5.3).
Race
Class
Fra datoen for kundgørelse af Kommissionens afgørelse
From the date of notification of the Commission Decision
Methotrexat-holdige lægemidler til oral anvendelse med mindst én indikation, der kræver indgivelse én gang ugentligt Den enkelte indehaver af markedsføringstilladelse bør have et risikostyringssystem, der skal beskrives i en risikostyringsplan (RMP), som skal indsendes til de relevante kompetente myndigheder.
Methotrexate-containing products for oral use with at least one indication requiring once weekly dosing Each MAH should operate a risk management system to be described in a risk management plan (RMP) which shall be submitted to the relevant Competent Authorities.
Senest 3 måneder efter Kommissionens afgørelse
Within 3 months after Commission decision
Alle methotrexat-holdige lægemidler Den enkelte indehaver af markedsføringstilladelse bør anvende de vedtagne målrettede opfølgningsspørgeskemaer for alle medicineringsfejl, der medfører overdosering.
All methotrexate-containing products Each MAH should implement the agreed targeted follow-up questionnaires for all medication errors resulting in overdose.
Senest 4 år efter Kommissionens afgørelse
Within 4 years after Commission decision