FrancophonIA/ELRC3.0 huggingface dataset:
English: MRL required
Danish: MRL ikke påkrævet
English: 1) There are important outstanding issues regarding the differences of production and control between the manufacturing sites (including the nature of the eggs used) and the lack of a validation study for the potency test on finished product (it appears that final product tests are only done at Weesp but in-process tests such as titration and HA quantification need to be equivalent too).
Danish: 1) Der er vigtige spørgsmål Fremragende Hvad angår produktion af forskelle mellem kontrol-og produktionssteder (herunder karakteren af den anvendte æg) og manglen på en valideringsundersøgelse for styrkeprøven på færdige produkt (det viser sig, at slutproduktet tests kun gøres på Weesp Men i en tør-proces prøver og titrering og kvantificering af HA har brug for: at være ækvivalente for).
English: Any person intending to import, sell, supply and/or use Poulvac FluFend H5N3 RG must consult the relevant Member States competent authority on the current vaccination policies prior to the import, sale, supply and/or use.
Danish: Enhver person, som har til hensigt at indføre, sælge, levere og/eller anvende Poulvac Flufend H5N3 RG Vet, skal rådføre sig med den relevante medlemsstats kompetente myndighed vedrørende gældende vaccinationspolitik forinden indførsel, salg, levering og/eller anvendelse finder sted.
English: consumption, with the exception of preservatives listed in part C of Annex III to European Parliament and Council Directive 95/2/EC
Danish: Kun stoffer, der er godkendt som fødevaretilsætningsstoffer, med undtagelse af konserveringsmidler opført i del C i bilag III til EuropaParlamentets og Rådets direktiv 95/2/EF
English: According to Article 71 of Directive 2001/82/EC of the European Parliament and of the Council as amended, Member States prohibit or may prohibit the import, sale, supply and/or use of the veterinary medicinal product on the whole or part of their territory if it is established that:
Danish: I henhold til artikel 71 i Europa-Parlamentets og Rådets direktiv 2001/82/EF, med senere ændringer, kan en medlemsstat forbyde indførsel, salg, levering og/eller anvendelse af veterinærlægemidlet på hele eller en del af sit område, hvis det godtgøres:
English: The level of efficacy attained may vary depending on the degree of antigenic homology between the vaccine strain and circulating field strains.
Danish: Den opnåede virkning kan variere afhængig af antigen homologi mellem vaccinestammen og de eksisterende feltstammer.
English: Chickens and ducks.
Danish: Kyllinger og ænder.
English: Pharmacotherapeutic group: Inactivated recombinant vaccine, ATC vet code: QI01AA23
Danish: Farmakoterapeutisk gruppe: Inaktiveret rekombinant vaccine, ATCvet-kode: QI01AA23
English: The use of this veterinary medicinal product is only allowed under the particular conditions established by European Community legislation on the control of Avian Influenza.
Danish: Brug af dette veterinærlægemiddel er kun tilladt under de særlige omstændigheder fastsat af den Europæiske Fællesskabs lovgivning vedrørende bekæmpelsen af aviær influenza.
English: The holder of this marketing authorisation must inform the European Commission about the marketing plans for the medicinal product authorised by this decision.
Danish: Indehaveren af markedsføringstilladelsen må bekendtgøre sine markedsføringsplaner vedrørende dette veterinærlægemiddel til Europa-Kommissionen.
English: Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with the local requirements.
Danish: Eventuelle ubrugte lægemidler eller affald fra sådanne produkter skal destrueres i overensstemmelse med kommunale krav.
English: White oil is a mineral hydrocarbon, Arlacel 83V is sorbitan sesquioleate, Tween 80 is polyoxyethylene sorbitan monooleate, sodium phosphate dibasic (E339) and potassium phosphate monobasic (E340) are substances with E numbers.
Danish: Hvid olie er et mineralsk hydrocarbon, Arlacel 83V er sorbitansesquioleat, Tween 80 er polyoxyethylensorbitanmonooleat, dinatriumphosphat (E339) og kaliumdihydrogenphosphat (E340) er stoffer med E-numre.
English: The Marketing Authorisation Holder shall complete the following programme of studies, the results of which shall form the basis of the annual reassessment of the benefit/risk profile.
Danish: Resultaterne af undersøgelserne vil danne grundlaget for den årlige revurdering af benefit/risk-forholdet.
English: None
Danish: Ingen.
English: 4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary Following the administration of a double dose in chickens and ducks, no adverse reactions other than those described in section 4.6 have been observed.
Danish: 4.10 Overdosering (symptomer, nødforanstaltninger, modgift), om nødvendigt Hos kyllinger og ænder viste administration af dobbeltdosis ingen anden effekt end efter administration af en enkeltdosis (se punkt 4.6).
English: All food producing species
Danish: Alle arter bestemt til fødevareproduktion
English: SPECIAL WARNINGS, IF NECESSARY Accidental injection is dangerous.
Danish: SÆRLIG(E) ADVARSEL/ADVARSLER, OM NØDVENDIGT Utilsigtet injektion er farlig.
English: Mineral hydrocarbons, low to high viscosity including microcrystalline waxes, approximately C10-C60, aliphatic, branched aliphatic and alicyclic compounds
Danish: Mineralske hydrocarboner, lav til høj viskositet inklusive mikrokrystallinske vokser, ca. C10-C60, alifatiske, forgrenede alifatiske og alicykliske forbindelser
English: PACKAGE SIZE 500 ml
Danish: PAKNINGSSTØRRELSE 500 ml
English: MANUFACTURER'S BATCH NUMBER Lot (Number)
Danish: FREMSTILLERENS BATCHNUMMER Lot {nummer}
English: No information is available on the safety of this vaccine for birds in lay.
Danish: Der foreligger ingen information om brug af denne vaccine til æglæggende fugle.
English: STATEMENT OF ACTIVE AND OTHER SUBSTANCES One dose of 0.5 ml contains:
Danish: ANGIVELSE AF AKTIVE STOFFER OG ANDRE STOFFER En dosis på 0,5 ml indeholder:
English: The import, sale, supply and/or use of Poulvac FluFend H5N3 RG is or may be prohibited in certain Member States on the whole or part of their territory pursuant to national animal health policy.
Danish: Indførsel, salg, levering og/eller anvendelse af Poulvac Flufend H5N3 RG Vet er eller kan være forbudt i visse medlemsstater på dele af eller hele deres område.
English: ADVICE ON CORRECT ADMINISTRATION Do not mix with any other medicinal product.
Danish: OPLYSNINGER OM KORREKT ANVENDELSE Må ikke blandes med andre lægemidler.
English: If you are accidentally injected with this product, seek prompt medical advice even if only a very small amount is injected and take the package leaflet with you.
Danish: Hvis De ved et uheld injiceres med dette produkt, skal De søge omgående lægehjælp, også selvom det kun drejer sig om en meget lille mængde.
English: a) the administration of the veterinary medicinal product to animals will interfere with the implementation of national programmes for the diagnosis, control and eradication of animal diseases, or will cause difficulties in certifying the absence of contamination in live animals or in foodstuffs or other products obtained from treated animals b) the disease to which the veterinary medicinal product is intended to confer immunity is largely absent from the territory.
Danish: a) at behandling af dyr med lægemidlet griber forstyrrende ind i gennemførelsen af et nationalt program til diagnosticering, bekæmpelse eller udryddelse af sygdomme hos dyr eller gør det vanskeligt at bekræfte, at levende dyr eller levnedsmidler eller andre produkter hidrørende fra behandlede dyr ikke er kontamineret,
English: DOSAGE FOR EACH SPECIES, ROUTES AND METHOD OF ADMINISTRATION
Danish: DOSERING FOR HVER DYREART, ANVENDELSESMÅDE OG INDGIVELSESVEJ(E)
English: Duration of immunity in ducks : 14 weeks after the second injection.
Danish: Immunitetsvarigheden hos ænder: 14 uger efter den anden injektion.
English: SPECIFIC OBLIGATIONS TO BE FULFILLED BY THE MARKETING AUTHORISATION HOLDER
Danish: SPECIFIKKE FORPLIGTELSER, SOM SKAL OPFYLDES AF INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN
English: The following constituents of Poulvac FluFend H5N3 RG are included in Table 1 (Allowed substances) of the annex to Commission Regulation (EU) No 37/2010 as follows:
Danish: Følgende indholdsstoffer i Poulvac FluFend H5N3 RG er inkluderet i Tabel 1 (tilladte stoffer) i bilaget til Kommissionens forordning (EU) nr. 37/2010 som følger:
English: These constituents of Poulvac FluFend H5N3 RG are included in Table 1 (Allowed substances) of the annex to Commission Regulation (EU) No 37/2010 as follows:
Danish: Disse indholdsstoffer i Poulvac FluFend H5N3 RG er inkluderet i tablet 1 (tilladte stoffer) i bilaget til Kommissionens forordning (EU) nr. 37/2010 som følger:
English: Name and address of the manufacturer of the biological active substance(s)
Danish: Navn og adresse på fremstilleren af det biologisk aktive stof
English: For active immunisation of chickens and ducks against avian influenza virus type A, subtype H5.
Danish: Til aktiv immunisering af kyllinger og ænder mod fugleinfluenza type A, subtype H5.
English: PACKAGE SIZE 1 x 500 ml 10 x 500 ml
Danish: PAKNINGSSTØRRELSE 1 x 500 ml
English: THE WORDS ‘FOR ANIMAL TREATMENT ONLY' AND CONDITIONS OF RESTRICTIONS REGARDING SUPPLY AND USE, IF APPLICABLE
Danish: TEKSTEN “KUN TIL DYR” SAMT BETINGELSER ELLER BEGRÆNSNINGER FOR UDLEVERING OG BRUG, OM NØDVENDIGT
English: MARKETING AUTHORISATION NUMBER(S) EU/2/06/060/001-002
Danish: MARKEDSFØRINGSTILLADELSENS NUMMER (NUMRE) EU/2/06/060/001-002
English: Excludes aromatic and unsaturated compounds
Danish: Eksklusive aromatiske og umættede forbindelser
English: Inactivated recombinant avian influenza virus of H5N3 subtype (strain rg-A/ck/VN/C58/04)
Danish: Inaktiveret rekombinant aviær influenza virus, af subtypen H5N3 (stamme rg-A/ck/VN/C58/04)
English: Sorbitan sesquioleate Polysorbate 80
Danish: Paraffinolie, tynd Sorbitansesquioleat Polysorbat 80
English: Manufacturer for the batch release: Pfizer Global Manufacturing Weesp CJ van Houtenlaan 36
Danish: Fremstilleren (fremstillerne) ansvarlig for batchfrigivelse: Pfizer Global Manufacturing Weesp CJ van Houtenlaan 36
English: One dose of 0.5 ml contains:
Danish: En dosis på 0.5 ml indholder:
English: THE WORDS ‘FOR ANIMAL TREATMENT ONLY' AND CONDITIONS OF
Danish: TEKSTEN “KUN TIL DYR” SAMT BETINGELSER ELLER BEGRÆNSNINGER FOR
English: A transient local site reaction (swelling) may occasionally occur as is normal with oil adjuvanted vaccines.
Danish: Der kan af og til forekomme forbigående hævelser, hvilket er almindeligt for vacciner med olie-holdig adjuvans.
English: Expert, PROMPT, surgical attention is required and may necessitate early incision and irrigation of the injected area, especially where there is involvement of finger pulp or tendon.
Danish: Der kræves ØJEBLIKKELIG kirurgisk behandling, og der kan opstå behov for tidlig incision og irrigation af det injicerede område, navnlig når det drejer sig om finger-bløddele eller -sener.
English: No information is available on the interference of maternally derived antibodies on vaccination for both target species.
Danish: Der foreligger ingen information om interferens forårsaget af maternelle antistoffer hos nogen af dyrearterne.
English: 3 weeks of age or older: 0.5 ml intramuscularly in the breast muscle.
Danish: Fra 3 uger: En dosis på 0,5 ml gives intramuskulært i brystmusklen.
English: Emulsion for injection for chickens and ducks
Danish: Injektionsvæske, emulsion til kyllinger og ænder
English: PHARMACEUTICAL FORM Emulsion for injection.
Danish: LÆGEMIDDELFORM Injektionsvæske, emulsion.
English: In particular, a rationalization of the nature of eggs used (taking into consideration the problem of the possible presence of extraneous agents in conventional eggs and the possibility to inactivate them during the inactivation process of the Influenza virus, supported by a corresponding validation study).
Danish: En rationalisering af arten af æg, der anvendes (med hensyn til problemet med mulig tilstedeværelse af fremmede agenser med konventionelle æg og muligheden for, at inaktivere dem under inaktiveringsproces af influenza-virus, der støttes af en tilsvarende valideringsundersøgelse) Ansøgeren bliver bedt om at forpligte at træffe passende foranstaltninger for at harmonisere produktioner og / eller give passende demonstrationer / data til at løse problemerne.
English: SPECIAL STORAGE CONDITIONS Store and transport refrigerated (2° to 8°C).
Danish: SÆRLIGE OPBEVARINGSBETINGELSER Opbevares og transporteres nedkølet (2°C -8°C).
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Poulvac FluFend H5N3 RG emulsion for injection for chickens and ducks
Danish: VETERINÆRLÆGEMIDLETS NAVN Poulvac FluFend H5N3 RG Injektionsvæske, emulsion til kyllinger og ænder
English: For disposal read the package leaflet.
Danish: Forholdsreglerne for bortskaffelse kan læses i indlægssedlen.
English: To stimulate active immunity in chickens and ducks against avian influenza virus, H5 subtype.
Danish: Stimulerer aktiv immunitet hos kyllinger og ænder mod fugleinfluenza (aviær influenza) virus, subtype H5.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE CARTON LABEL
Danish: OPLYSNINGER, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE
English: PHARMACEUTICAL FORM Emulsion for injection
Danish: LÆGEMIDDELFORM Injektionsvæske, emulsion
English: WITHDRAWAL PERIOD Withdrawal period: Zero days
Danish: TILBAGEHOLDELSESTID Tilbageholdelsestid: 0 døgn
English: 6.5 Nature and composition of immediate packaging 500 ml of vaccine in high-density polyethylene bottles, closed with a nitrile rubber stopper and aluminium cap.
Danish: 500 ml flaske af “high-density” polyethylen, lukket med gummiprop og forseglet med aluminiumskapsel.
English: E. SPECIFIC OBLIGATIONS TO BE FULFILLED BY THE MARKETING AUTHORISATION HOLDER
Danish: E. SPECIFIKKE FORPLIGTELSER, SOM SKAL OPFYLDES AF INDEHAVEREN AF
English: Animal
Danish: Dyreart
English: RESTRICTIONS REGARDING SUPPLY AND USE, if applicable For animal treatment only
Danish: UDLEVERING OG BRUG, OM NØDVENDIGT Kun til dyr.
English: Store and transport refrigerated (2° to 8°C).
Danish: Opbevares og transporteres nedkølet (2°C - 8°C).
English: MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE
Danish: FREMSTILLER(E) AF DE(T) BIOLOGISK AKTIVE STOF(FER) OG INDEHAVER(E) AF VIRKSOMHEDSGODKENDELSE ANSVARLIG FOR BATCHFRIGIVELSE
English: TARGET SPECIES Chickens and ducks
Danish: DYREARTER Kyllinger og ænder
English: For animal treatment only
Danish: Kun til dyr.
English: Onset of immunity: 3 weeks after the second injection.
Danish: Der opnås immunitet 3 uger efter den anden vaccination.
English: A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH
Danish: A. FREMSTILLER(E) AF DE(T) BIOLOGISK AKTIVE STOF(FER) OG INDEHAVER(E) AF VIRKSOMHEDSGODKENDELSE ANSVARLIG FOR BATCHFRIGIVELSE
English: Revaccinate after 3 weeks.
Danish: Anden dosis gives 3 uger senere.
English: STATEMENT OF ACTIVE AND OTHER SUBSTANCES
Danish: ANGIVELSE AF DE(T) AKTIVE STOF(FER) OG ANDRE INDHOLDSSTOFFER
English: At one day old: 0.2 ml subcutaneously in the neck.
Danish: Når ællingen er én dag gammel: En dosis på 0,2 ml gives subkutant i nakken.
English: Sodium chloride
Danish: Natriumchlorid Ikke relevant
English: Chickens: Reduction of mortality and virus excretion after challenge.
Danish: Kyllinger: reducering af dødsfald og virusudskillelse efter infektion.
English: Sorbitan sesquioleate
Danish: Sorbitansesquioleat
English: Excipients:
Danish: Ænder:
English: THE WORDS “KEEP OUT OF THE REACH AND SIGHT OF CHILDREN” Keep out of the reach and sight of children
Danish: TEKSTEN “OPBEVARES UTILGÆNGELIGT FOR BØRN” Opbevares utilgængeligt for børn.
English: SPECIAL STORAGE CONDITIONS
Danish: EVENTUELLE SÆRLIGE FORHOLDSREGLER VEDRØRENDE OPBEVARING
English: 6.6 Special precautions for the disposal of unused veterinary medicinal products or waste material derived from the use of such products
Danish: 6.6 Eventuelle særlige forholdsregler ved bortskaffelse af ubrugte veterinærlægemidler eller
English: Adjuvants:
Danish: Hjælpestoffer:
English: Ducks: Reduction of clinical signs and virus excretion after challenge.
Danish: Ænder: reducering af kliniske symptomer og virusudskillelse efter infektion.
English: Reduction of clinical signs and virus excretion after challenge.
Danish: Reducering af kliniske symptomer og virusudskillelse efter infektion.
English: Reduction of mortality and virus excretion after challenge.
Danish: Reducering af dødsfald og virusudskillelse efter infektion.
English: Ducks
Danish: Ænder
English: Sodium phosphate dibasic
Danish: Natriumchlorid Dinatriumhydrogenphosphat Kaliumdihydrogenphosphat
English: CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION REGARDING SUPPLY OR USE
Danish: BETINGELSER FOR MARKEDSFØRINGSTILLADELSEN, HERUNDER BEGRÆNSNINGER FOR UDLEVERING OG BRUG
English: MRLs Target
Danish: MRL Målvæv Andre bestemmelser
English: Revaccinate after 3 weeks: 0.5 ml subcutaneously in the neck The vaccination schedule should be completed at least 4 weeks before the start of laying.
Danish: Anden dosis på 0,5 ml gives subkutant i nakken 3 uger senere.
English: A decision to use this vaccine before or after any other veterinary medicinal product therefore needs to be made on a case by case basis Following the administration of a double dose in chickens and ducks, no adverse reactions other than those described in section 6 have been observed.
Danish: Hos kyllinger og ænder viste administration af dobbeltdosis ingen anden effekt end efter administration af en enkeltdosis.
English: EXPIRY DATE EXP (month/year) Once broached, use within 2 hours.
Danish: {måneder/år} Anvendes inden for 2 timer efter anbrud.
English: Phosphate Buffer Saline
Danish: Phosphatbufferopløsning
English: This section was partly restructured according to guidelines.
Danish: Dette punkt blev delvis omstruktureret i henhold til retningslinjerne.
English: In general the Core Safety Profile, dated 2 April 2009 was considered.
Danish: Generelt blev sikkerhedsprofilen af 2. april 2009 taget i betragtning.
English: There are differences between all Member States concerning the individual paragraphs in this section.
Danish: Der er forskelle mellem alle medlemsstaterne vedrørende de forskellige afsnit i dette punkt.
English: In addition minor typographic errors were corrected.
Danish: Desuden blev mindre typografiske fejl rettet.
English: Neutropenic patients are at especially high risk for candidemia.
Danish: Neutropene patienter har særlig høj risiko for candidæmi.
English: However in very rare cases treatment in adolescents is imperative (i.e. no other (especially local) treatment option is appropriate) and these cases should not be totally excluded from treatment.
Danish: I meget sjældne tilfælde er behandling af unge imidlertid ubetinget nødvendig (dvs. ingen anden behandlingsmulighed (særligt lokal) er velegnet), og disse tilfælde bør ikke udelukkes fuldstændigt fra behandling.
English: In addition the paediatric indications have been clarified.
Danish: Derudover er de pædiatriske indikationer blevet klarlagt.
English: So a warning has been added in this section.
Danish: Derfor er der tilføjet en advarsel i dette punkt.
English: A harmonised Module 3 was also adopted.
Danish: Et harmoniseret afsnit 3 blev også vedtaget.
English: An EU work sharing project-Assessment of Paediatric data took place in 2005-2006.
Danish: Et samarbejdsprojekt på EU-plan, Assessment of Paediatric data, fandt sted i 2005-2006.
English: Overall summary of the scientific evaluation of Diflucan and associated names (see Annex I)
Danish: Samlet resumé af den videnskabelige vurdering af Diflucan og relaterede navne (se bilag I)
English: Acute oral candidiasis may occur in up to 5% of newborn infants.
Danish: Akut oral candidiasis kan forekomme hos op til 5 % af nyfødte.
English: In most patients, symptoms should resolve within days after the start of effective therapy.
Danish: Hos de fleste patienter bør symptomerne forsvinde inden for få dage efter start af effektiv behandling.
English: • Invasive candidiasis.
Danish: • Invasiv candidiasis.
English: • To reduce the incidence of recurrent vaginal candidiasis (4 or more episodes a year).
Danish: • For at reducere forekomsten af recidiverende vaginal candidiasis (4 episoder eller flere pr. år).
English: The incidences in the endemic areas of these fungal infections are increasing and the population travelling toward its specific endemic regions in the United States and Southern America is growing.
Danish: Incidensen i de endemiske områder for disse svampeinfektioner er stigende, og populationen, som bevæger sig mod de specifikke endemiske regioner i USA og Sydamerika, er voksende.
English: The proposed text for the pharmokinetics in children is the wording that was agreed during the EU work sharing project.
Danish: Den foreslåede tekst for farmakokinetik hos børn er den formulering, der blev godkendt under arbejdsdelingsprojektet på EU-plan.
English: Endemic mycoses remain a major public health problem in several countries and they are becoming increasingly frequent with the spread of HIV infection.
Danish: Endemiske mykoser er fortsat et stort sundhedsmæssigt problem i flere lande, og de bliver hyppigere med spredningen af hiv-infektion.
English: Thus the outcome of this referral procedure does not include any evaluation of the gel formulation.
Danish: Derfor omfatter udfaldet af denne indbringelsesprocedure ikke nogen evaluering af gelformuleringen.
English: This results in a dosing regimen in children that is equivalent to that in adults.
Danish: Det resulterer i et dosisregime hos børn, som svarer til regimet hos voksne.
English: Consideration should be given to official guidance on the appropriate use of antifungals.
Danish: Der skal tages højde for de officielle retningslinjer for korrekt anvendelse af antimykotika.
English: The concomitant use of fluconazole and halofantrine is therefore not recommended.
Danish: Samtidig brug af fluconazol og halofantrin anbefales derfor ikke.
English: The use of fluconazole for the above indications is also supported by the Infectious Diseases Society of America (IDSA) guidelines.
Danish: Anvendelsen af fluconazol til ovenstående indikationer understøttes også af retningslinjer fra Infectious Diseases Society of America (IDSA).
English: Antifungal agents are being used in many prophylactic settings, but only a few studies have adequately evaluated their efficacy.
Danish: Antimykotika anvendes i mange profylaktiske situationer, men kun få undersøgelser har i tilstrækkelig grad evalueret deres virkning.
English: The incidence of oesophageal candidiasis is around 0.08 per 100 child-years after introduction of HAART in around 2001.
Danish: Forekomsten af øsofageal candidiasis er cirka 0,08 per 100 børneår efter indførelsen af HAART omkring 2001.
English: Additional data were available from a compassionate use study (EU, 2006).
Danish: Yderligere data var tilgængelige fra programmet med særlig udleveringstilladelse (EU, 2006).
English: Cryptococcosis is a defining opportunistic infection for AIDS.
Danish: Kryptokokkose er en definerende, opportunistisk infektion for aids.
English: A warning on tinea capitis and the fact that should not be used in children has been added.
Danish: Der er tilføjet en advarsel om tinea capitis, og at det ikke bør anvendes til børn.
English: Cryptococcal infections in children
Danish: Kryptokokinfektioner hos børn
English: It was also generally well tolerated and there were no changes of clinical significance at doses of up to and including 400 mg/day.
Danish: Det var også generelt veltolereret, og der var ingen ændringer i klinisk signifikans ved doser på til og med 400 mg dagligt.
English: During the time of the evaluation of the procedure the Marketing Authorisation Holder (MAH) voluntarily withdrew the gel formulation from the European Market.
Danish: I løbet af evalueringsproceduren trak indehaveren af markedsføringstilladelsen frivilligt gelformuleringen tilbage fra det europæiske marked.