natgillin/translations-raw huggingface dataset:
VETERINÆRLÆGEMIDLETS NAVN Poulvac FluFend H5N3 RG Injektionsvæske, emulsion til kyllinger og ænder
NAME OF THE VETERINARY MEDICINAL PRODUCT Poulvac FluFend H5N3 RG emulsion for injection for chickens and ducks
Forholdsreglerne for bortskaffelse kan læses i indlægssedlen.
For disposal read the package leaflet.
Stimulerer aktiv immunitet hos kyllinger og ænder mod fugleinfluenza (aviær influenza) virus, subtype H5.
To stimulate active immunity in chickens and ducks against avian influenza virus, H5 subtype.
OPLYSNINGER, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE
PARTICULARS TO APPEAR ON THE OUTER PACKAGE CARTON LABEL
LÆGEMIDDELFORM Injektionsvæske, emulsion
PHARMACEUTICAL FORM Emulsion for injection
TILBAGEHOLDELSESTID Tilbageholdelsestid: 0 døgn
WITHDRAWAL PERIOD Withdrawal period: Zero days
500 ml flaske af “high-density” polyethylen, lukket med gummiprop og forseglet med aluminiumskapsel.
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.
E. SPECIFIKKE FORPLIGTELSER, SOM SKAL OPFYLDES AF INDEHAVEREN AF
E. SPECIFIC OBLIGATIONS TO BE FULFILLED BY THE MARKETING AUTHORISATION HOLDER
Dyreart
Animal
UDLEVERING OG BRUG, OM NØDVENDIGT Kun til dyr.
RESTRICTIONS REGARDING SUPPLY AND USE, if applicable For animal treatment only
Opbevares og transporteres nedkølet (2°C - 8°C).
Store and transport refrigerated (2° to 8°C).
FREMSTILLER(E) AF DE(T) BIOLOGISK AKTIVE STOF(FER) OG INDEHAVER(E) AF VIRKSOMHEDSGODKENDELSE ANSVARLIG FOR BATCHFRIGIVELSE
MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE
DYREARTER Kyllinger og ænder
TARGET SPECIES Chickens and ducks
Kun til dyr.
For animal treatment only
Der opnås immunitet 3 uger efter den anden vaccination.
Onset of immunity: 3 weeks after the second injection.
A. FREMSTILLER(E) AF DE(T) BIOLOGISK AKTIVE STOF(FER) OG INDEHAVER(E) AF VIRKSOMHEDSGODKENDELSE ANSVARLIG FOR BATCHFRIGIVELSE
A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH
Anden dosis gives 3 uger senere.
Revaccinate after 3 weeks.
ANGIVELSE AF DE(T) AKTIVE STOF(FER) OG ANDRE INDHOLDSSTOFFER
STATEMENT OF ACTIVE AND OTHER SUBSTANCES
Når ællingen er én dag gammel: En dosis på 0,2 ml gives subkutant i nakken.
At one day old: 0.2 ml subcutaneously in the neck.
Natriumchlorid Ikke relevant
Sodium chloride
Kyllinger: reducering af dødsfald og virusudskillelse efter infektion.
Chickens: Reduction of mortality and virus excretion after challenge.
Sorbitansesquioleat
Sorbitan sesquioleate
Ænder:
Excipients:
TEKSTEN “OPBEVARES UTILGÆNGELIGT FOR BØRN” Opbevares utilgængeligt for børn.
THE WORDS “KEEP OUT OF THE REACH AND SIGHT OF CHILDREN” Keep out of the reach and sight of children
EVENTUELLE SÆRLIGE FORHOLDSREGLER VEDRØRENDE OPBEVARING
SPECIAL STORAGE CONDITIONS
6.6 Eventuelle særlige forholdsregler ved bortskaffelse af ubrugte veterinærlægemidler eller
6.6 Special precautions for the disposal of unused veterinary medicinal products or waste material derived from the use of such products
Hjælpestoffer:
Adjuvants:
Ænder: reducering af kliniske symptomer og virusudskillelse efter infektion.
Ducks: Reduction of clinical signs and virus excretion after challenge.
Reducering af kliniske symptomer og virusudskillelse efter infektion.
Reduction of clinical signs and virus excretion after challenge.
Reducering af dødsfald og virusudskillelse efter infektion.
Reduction of mortality and virus excretion after challenge.
Ænder
Ducks
Natriumchlorid Dinatriumhydrogenphosphat Kaliumdihydrogenphosphat
Sodium phosphate dibasic
BETINGELSER FOR MARKEDSFØRINGSTILLADELSEN, HERUNDER BEGRÆNSNINGER FOR UDLEVERING OG BRUG
CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION REGARDING SUPPLY OR USE
MRL Målvæv Andre bestemmelser
MRLs Target
Anden dosis på 0,5 ml gives subkutant i nakken 3 uger senere.
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.
Hos kyllinger og ænder viste administration af dobbeltdosis ingen anden effekt end efter administration af en enkeltdosis.
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.
{måneder/år} Anvendes inden for 2 timer efter anbrud.
EXPIRY DATE EXP (month/year) Once broached, use within 2 hours.
Phosphatbufferopløsning
Phosphate Buffer Saline
Dette punkt blev delvis omstruktureret i henhold til retningslinjerne.
This section was partly restructured according to guidelines.
Generelt blev sikkerhedsprofilen af 2. april 2009 taget i betragtning.
In general the Core Safety Profile, dated 2 April 2009 was considered.
Der er forskelle mellem alle medlemsstaterne vedrørende de forskellige afsnit i dette punkt.
There are differences between all Member States concerning the individual paragraphs in this section.
Desuden blev mindre typografiske fejl rettet.
In addition minor typographic errors were corrected.
Neutropene patienter har særlig høj risiko for candidæmi.
Neutropenic patients are at especially high risk for candidemia.
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.
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.
Derudover er de pædiatriske indikationer blevet klarlagt.
In addition the paediatric indications have been clarified.
Derfor er der tilføjet en advarsel i dette punkt.
So a warning has been added in this section.
Et harmoniseret afsnit 3 blev også vedtaget.
A harmonised Module 3 was also adopted.
Et samarbejdsprojekt på EU-plan, Assessment of Paediatric data, fandt sted i 2005-2006.
An EU work sharing project-Assessment of Paediatric data took place in 2005-2006.
Samlet resumé af den videnskabelige vurdering af Diflucan og relaterede navne (se bilag I)
Overall summary of the scientific evaluation of Diflucan and associated names (see Annex I)
Akut oral candidiasis kan forekomme hos op til 5 % af nyfødte.
Acute oral candidiasis may occur in up to 5% of newborn infants.
Hos de fleste patienter bør symptomerne forsvinde inden for få dage efter start af effektiv behandling.
In most patients, symptoms should resolve within days after the start of effective therapy.
• Invasiv candidiasis.
• Invasive candidiasis.
• For at reducere forekomsten af recidiverende vaginal candidiasis (4 episoder eller flere pr. år).
• To reduce the incidence of recurrent vaginal candidiasis (4 or more episodes a year).
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.
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.
Den foreslåede tekst for farmakokinetik hos børn er den formulering, der blev godkendt under arbejdsdelingsprojektet på EU-plan.
The proposed text for the pharmokinetics in children is the wording that was agreed during the EU work sharing project.
Endemiske mykoser er fortsat et stort sundhedsmæssigt problem i flere lande, og de bliver hyppigere med spredningen af hiv-infektion.
Endemic mycoses remain a major public health problem in several countries and they are becoming increasingly frequent with the spread of HIV infection.
Derfor omfatter udfaldet af denne indbringelsesprocedure ikke nogen evaluering af gelformuleringen.
Thus the outcome of this referral procedure does not include any evaluation of the gel formulation.
Det resulterer i et dosisregime hos børn, som svarer til regimet hos voksne.
This results in a dosing regimen in children that is equivalent to that in adults.
Der skal tages højde for de officielle retningslinjer for korrekt anvendelse af antimykotika.
Consideration should be given to official guidance on the appropriate use of antifungals.
Samtidig brug af fluconazol og halofantrin anbefales derfor ikke.
The concomitant use of fluconazole and halofantrine is therefore not recommended.
Anvendelsen af fluconazol til ovenstående indikationer understøttes også af retningslinjer fra Infectious Diseases Society of America (IDSA).
The use of fluconazole for the above indications is also supported by the Infectious Diseases Society of America (IDSA) guidelines.
Antimykotika anvendes i mange profylaktiske situationer, men kun få undersøgelser har i tilstrækkelig grad evalueret deres virkning.
Antifungal agents are being used in many prophylactic settings, but only a few studies have adequately evaluated their efficacy.
Forekomsten af øsofageal candidiasis er cirka 0,08 per 100 børneår efter indførelsen af HAART omkring 2001.
The incidence of oesophageal candidiasis is around 0.08 per 100 child-years after introduction of HAART in around 2001.
Yderligere data var tilgængelige fra programmet med særlig udleveringstilladelse (EU, 2006).
Additional data were available from a compassionate use study (EU, 2006).
Kryptokokkose er en definerende, opportunistisk infektion for aids.
Cryptococcosis is a defining opportunistic infection for AIDS.
Der er tilføjet en advarsel om tinea capitis, og at det ikke bør anvendes til børn.
A warning on tinea capitis and the fact that should not be used in children has been added.
Kryptokokinfektioner hos børn
Cryptococcal infections in children
Det var også generelt veltolereret, og der var ingen ændringer i klinisk signifikans ved doser på til og med 400 mg dagligt.
It was also generally well tolerated and there were no changes of clinical significance at doses of up to and including 400 mg/day.
I løbet af evalueringsproceduren trak indehaveren af markedsføringstilladelsen frivilligt gelformuleringen tilbage fra det europæiske marked.
During the time of the evaluation of the procedure the Marketing Authorisation Holder (MAH) voluntarily withdrew the gel formulation from the European Market.
Metoden og den statistiske fremgangsmåde samt de indsendte data blev gennemgået, og CHMP anså den anslåede hyppighed for at være passende.
The method and the statistical approach together with the data provided were reviewed and the CHMP considered the estimated frequency to be appropriate.
Desuden kunne fluconazol også fås til topikal anvendelse i en formulering som 0,5 % gel.
Furthermore, fluconazole was also available for topical use in the 0.5% gel formulation.
Der var også forskelle i ordlyden i doseringsanbefalingen for unge og børn ved alle indikationer.
There were also differences in the wording on the dosage recommendation for adolescents and children regarding all indications.
For patienter med nedsat nyrefunktion er der tilføjet en advarsel med en krydsreference til punktet med dosering 4.2 for denne patientpopulation.
For patients with renal impairment a warning has been added with a cross reference to the posology section of 4.2 in this patient population.
Farmakokinetiske data blev bedømt for 113 pædiatriske patienter fra 5 undersøgelser: 2 enkeltdosisundersøgelser, 2 flerdosisundersøgelser og en undersøgelse hos for tidligt fødte.
Pharmacokinetic data were assessed for 113 paediatric patients from 5 studies; 2 single-doses studies, 2 multiple-dose studies, and a study in premature neonates.
Særligt blev indikationerne og deres tilhørende doseringsanbefalinger harmoniseret.
In particular, the indications and their associated posology recommendations were harmonised.
Opløseligheden giver mulighed for såvel oral som intravenøs administration.
The solubility characteristic allows oral as well as intravenous administration.
Profylaktisk anvendelse af Diflucan separat fra behandlingsindikationerne blev også drøftet og begrundet.
The prophylactic use of Diflucan, as distinct from the treatment indications was also discussed and justified.
Der er tilføjet mere omfattende information i punkt 4.5 i produktresuméet.
More extensive information has been added in section 4.5 of the SPC.
Brug af fluconazol til behandling af svampeinfektioner i huden er undersøgt i flere sammenlignende og ikke-sammenlignende undersøgelser.
The use of fluconazole for the treatment of fungal skin infections was examined in several comparative and non-comparative studies.
Efter at CHMP havde taget spørgsmålet op, fremlagde indehaveren af markedsføringstilladelsen en dosering for denne specifikke aldersgruppe baseret på "Guideline on the role of pharmacokinetics in the development of medicinal product in the paediatric population, 2006".
Following questions raised by the CHMP the MAH provided a posology for this specific age group based on the “Guideline on the role of pharmacokinetics in the development of medicinal product in the paediatric population, 2006.”
Fluconazols farmakokinetiske profil hos børn har et velkendt forhold til profilen hos voksne, når der tages højde for distributionsvolumen og clearance.
The pharmacokinetic profile of fluconazole in children has a well understood relationship to that in adults when volume of distribution and clearance are taken into account.
Punkt 4.1 - Terapeutiske indikationer
Section 4.1 - Therapeutic Indications
Denne indikation indeholder ikke referencer til individuelle former for invasive candidainfektioner.
This indication does not make any more reference to individual forms of invasive candidal infections.
Punkt 4.4 - Særlige advarsler og forsigtighedsregler vedrørende brugen
Section 4.4 - Special warnings and precaution for use
CHMP vurderede lægemidlets produktinformation under hensyntagen til de eksisterende nationale produktresuméer og den eksisterende faglig viden og drøftede indikationerne for hver enkelt medicinsk tilstand.
The CHMP assessed the Product Information of the product taking into account the current national ones and the existing scientific knowledge and discussed the indications for each individual medical condition.
De oprindelige ansøgninger til indikationen forebyggelse af svampeinfektioner indeholdt syv kliniske sammenlignende undersøgelser, hvor 755 patienter fik oral fluconazol, 383 patienter placebo og 374 patienter orale sammenlignende midler.
The original applications for the prevention of fungal infections indication included seven comparative clinical studies in which 755 patients received oral fluconazole, 383 patients placebo and 374 patients oral comparative agents.
Selvom C. neoformans typisk inficerer immunkompromitterede personer, udvikler patienter uden åbenlyse problemer med immunsystemet også kryptokokkose.
Although C. neoformans typically infects immunocompromised persons, patients with no apparent immune system problems also develop cryptococcosis.
Orofaryngeal candidiasis (OPC) er fortsat en af de hyppigst forekommende opportunistiske infektioner hos hiv-inficerede børn under HAART (Highly Active Anti-Retroviral Therapy)-perioden (28 % af børnene) med en forekomst på 0,93 per 100 børneår.
Oropharyngeal candidiasis (OPC) continues to be one of the most frequent opportunistic infections in HIV-infected children during the Highly Active Anti-Retroviral Therapy (HAART) era (28% of children), with an incidence rate of 0.93 per 100 child-years.
Denne formulering var kun godkendt i Italien og var indiceret til behandling af dermatomykose, som skyldes dermatofytter, gær og skimmelsvampe.
This formulation was only approved in Italy and was indicated for the treatment of dermatomycoses due to dermatophytes, yeasts and moulds.
Candida øsofagitis ses stadig hos børn, som ikke responderer på antiretroviral behandling.
Candida oesophagitis continues to be seen in children who are not responding to antiretroviral therapy.
Kryptokokinfektioner forekommer med større sandsynlighed i forbindelse med hiv-sygdom, men kryptokokinfektioner forekommer langt mindre hyppigt blandt hiv-inficerede børn end blandt voksne.
Cryptococcal infections are more likely to occur in association with HIV disease, however, cryptococcal infections occur much less frequently among HIV-infected children than among adults.
På baggrund af gennemgang af data vedtog CHMP et harmoniseret afsnit 3.
Based on the review of data the CHMP adopted a harmonised Module 3.
Behandling af invasiv candidiasis kræver højere doser fluconazol, end der anvendes til mukokutan sygdom.
Treatment of invasive candidiasis requires higher doses of fluconazole than are used for mucocutaneous disease.
Alle disse ændringer blev godkendt af CHMP.
All these changes were accepted by the CHMP.
Advarslen om virkningen på hjerte-kar-systemet og forbindelsen til et forlænget QT-interval på elektrokardiogrammet er understreget.
The warning on the effect on the cardiovascular system and the association with prolongation of the QT interval on the electrocardiogram has been reinforced.
Information om udvikling, fremstilling og kontrol af kapsler, pulver til oral suspension, syrup og infusionsvæske, opløsning er fremlagt på en tilfredsstillende måde.
Information on development, manufacture and control of capsules, powder for oral suspension, syrup and solution for infusion has been presented in a satisfactory manner.
Indikationen recidivforebyggelse hos immunkompromitterede (hiv- og cancer-) patienter blev undersøgt.
The indication of relapse prevention in immunocompromised (HIV and cancer) patients was investigated.
Øsofageal candidiasis er primært forbundet med hiv-infektion eller andre former for immunsuppression hos børn.
Oesophageal candidiasis is primarily associated with HIV infection or other forms of immunosuppression in children.
For at harmonisere doseringen foreslog indehaveren af markedsføringstilladelsen at medtage en tabel i punktet om dosering med de anbefalede doser for hver indikation og at skelne mellem behandling og forebyggelse.
In order to harmonise the posology the MAH was requested to include in the posology section a table with the recommended doses regarding each indication and to distinguish between treatment and prevention.
Desuden er CHMP af den opfattelse, at sikkerhed og virkning for indikationen genital candidiasis ikke er fastlagt hos den pædiatriske population, da alle tilgængelige data om børn og unge stammer fra undersøgelser med andre indikationer end genital candidiasis.
Furthermore the CHMP is of the opinion, that the safety and efficacy for indication of genital candidiasis has not been established in the paediatric population as all available data in children and adolescents are from studies in other indications rather than genital candidiasis.
Da oral absorption sker hurtigt og næsten komplet, er doserne af fluconazol, som anbefales til behandling og/eller profylakse ved de forskellige indikationer, de samme for oral (kapsler, oral suspension og syrup) og i.v.-administration.
Since oral absorption is rapid and almost complete, the doses of fluconazole recommended for the treatment and/or the prophylaxis of the different indications are the same for oral (capsules, oral suspension and syrup) and IV administration.
På grund af de divergerende nationale beslutninger i medlemsstaterne vedrørende godkendelse af ovenfor nævnte lægemidler (og relaterede navne) indgav Europa-Kommissionen meddelelse til CHMP/EMA-sekretariatet om en officiel indbringelse i henhold til artikel 30, stk. 2 , i direktiv 2001/83/EF med senere ændringer for at løse divergenser mellem de nationalt godkendte produktresuméer og dermed harmonisere de divergerende produktresuméer i EU.
Due to the divergent national decisions taken by Member States concerning the authorisation of the abovementioned products (and its associated names), the European Commission notified the CHMP/EMA Secretariat of an official referral under Article 30 of Directive 2001/83/EC as amended in order to resolve divergences amongst the nationally authorised SPCs and thus to harmonise its divergent SPCs across the European Union.
Alternativt kan der gives et indledende behandlingsforløb med amphotericin B, som derefter omhyggeligt følges af en fuld behandling med fluconazol.
Alternatively, an initial course of amphotericin B therapy can be administered and then carefully followed by completion of a course of fluconazole therapy.
Andre tilstande, som udgør en øget risiko, omfatter visse lymfomer (f.eks. Hodgkins lymfom), sarcoidose og patienter på langvarig kortikosteroid behandling.
Other conditions which pose an increased risk include certain lymphomas (e.g. Hodgkin's lymphoma), sarcoidosis, and patients on long-term corticosteroid therapy.
På baggrund af ovenstående anser CHMP benefit/risk-forholdet for Diflucan og relaterede navne for positivt og den harmoniserede produktinformation som egnet til godkendelse.
Based on the above, the CHMP considers the benefit/risk ratio of Diflucan and associated names to be favourable and the harmonised Product Information documents to be approvable.
Desuden har halofantrin vist sig at forlænge QTc-intervallet ved den anbefalede terapeutiske dosis og er et substrat af CYP3A4.
Moreover halofantrine has been shown to prolong QTc interval at the recommended therapeutic dose and is a substrate of CYP3A4.
Den generelle tekst om klassificering af hyppighed og de bivirkninger, der er blevet indberettet efter markedsføring, blev klarlagt, og hyppigheden af en række bivirkninger blev revideret.
The general text of frequencies classification, and the adverse reaction obtained from post-marketing experience were clarified, and the frequency of a number of events was revised.
Til indikationerne paracoccidioidomykose, histoplasmose, lymphokutan sporotrichose, hvor andre stoffer har været virkningsløse eller ikke er tolereret, mente CHMP, at de fremlagte data om effekt ikke var tilstrækkelige.
For the indications of paracoccidioidomycosis, histoplasmosis, lymphocutaneous sporotrichosis, where other agents have failed or are not tolerated, it was deemed by the CHMP that the submitted data on efficacy was not adequate.
Candidainfektioner er relativt almindelige i genitalområdet hos mænd og kvinder og responderer godt på oral administration af fluconazol.
Candidal infection of male and female genital areas is relatively common and responds well to an oral administration of fluconazole.
Brugen af bredspektret antibiotika, kortikosteroider, cytotoksiske lægemidler og strålebehandling er også disponerende faktorer.
The use of broad-spectrum antibiotics, corticosteroids, cytotoxic drugs, and radiation therapy are also predisposing factors.
KVALITET - AFSNIT 3
QUALITY - MODULE 3
Risikofaktorer for øsofageal candidiasis hos børn med hiv-infektioner omfatter et lavt CD4-tal (<100 celler/mm3), høj virusmængde og neutropeni (<500 celler/mm3).
Risk factors for oesophageal candidiasis in children with HIV infection include low CD4 count (<100 cells/mm3), high viral load, and neutropenia (<500 cells/mm3).
Desuden gør den farmakokinetiske profil det muligt at anvende fluconazol som enkeltstof på grund af den lange halveringstid på cirka 36 timer og distributionen i vaginas væv og sekreter med koncentrationer over den minimale hæmmende koncentration for C. albicans, som varede ved i mindst 72 timer.
In addition, the pharmacokinetic profile of fluconazole enables its use as a single agent due to its prolonged elimination half-life of approximately 36 hours and its distribution into vaginal tissues and secretions, with concentrations above the minimum inhibitory concentration for C. albicans persisting for at least 72 hours.
• Tinea unguinium (onychomykose,) når andre midler ikke betragtes som velegnede.
• Tinea unguinium (onychomycosis) when other agents are not considered appropriate.
Systemisk behandling er essentiel for øsofageal sygdom og skal indledes empirisk hos hiv-inficerede børn med OPC og øsofageale symptomer.
Systemic therapy is essential for oesophageal disease and should be initiated empirically among HIV-infected children who have OPC and oesophageal symptoms.