FrancophonIA/ELRC3.0 huggingface dataset:
English: Solamocta contains 800 mg amoxicillin trihydrate (equivalent to 697 mg amoxicillin) as an active substance per gram product.
Danish: Solamocta indeholder 800 mg amoxicillintrihydrat (svarende til 697 mg amoxicillin) som aktivt stof pr. g produkt.
English: The Committee recommended revised instructions on product administration and advice on prudent use to address responsible use in relation to development of antimicrobial resistance.
Danish: Udvalget anbefalede reviderede anvisninger om administration af produktet og anvisninger om forsvarlig brug hvad angår udviklingen af antimikrobiel resistens.
English: The Agency's Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the marketing authorisation for Solamocta can be granted provided that the recommended revised instructions on product administration and prudent use warnings are added to the product information.
Danish: Agenturets udvalg for lægemidler til dyr (CVMP) konkluderede, at der kan udstedes markedsføringstilladelse for Solamocta, forudsat at der i produktinformationen tilføjes de anbefalede reviderede anvisninger om administration af produktet og advarsler om forsvarlig brug.
English: Denmark considered that Solamocta is essentially different from the reference product Amoxinsol 100% w/w Powder for Oral Solution and that these differences could be sufficient to require a formal bioequivalence study.
Danish: Danmark fandt, at Solamocta adskiller sig væsentligt fra referenceproduktet Amoxinsol, pulver til oral opløsning, 100 % w/w, og at forskellene kan være tilstrækkelige til at nødvendiggøre en formel bioækvivalensundersøgelse.
English: Based on evaluation of the currently available data and the scientific discussion within the Committee, the CVMP concluded that a satisfactory justification has been provided that the product, Solamocta, is eligible for a waiver from the requirement to demonstrate in vivo bioequivalence with the reference product in accordance with section 7.1.c) of the CVMP guideline on the conduct of bioequivalence studies for veterinary medicinal products (EMA/CVMP/016/00-Rev.2) and that the excipients will not impact the bioavailability or safety of this product compared to the reference product.
Danish: På grundlag af vurderingen af de foreliggende data og den videnskabelige drøftelse i udvalget konkluderede CVMP, at der er givet en tilfredsstillende begrundelse for, at produktet Solamocta er berettiget til undtagelse fra kravet om påvisning af in vivo-bioækvivalens med referenceproduktet i overensstemmelse med afsnit 7.1.c) i CVMP's retningslinje om udførelse af bioækvivalensundersøgelse for lægemidler til dyr (EMA/CVMP/016/00-Rev.2), og at hjælpestofferne ikke vil have indflydelse på produktets bioækvivalens eller sikkerhed i forhold til referenceproduktets.
English: On 4 November 2015, the European Medicines Agency (the Agency) completed an arbitration procedure following a disagreement among Member States of the European Union (EU) regarding the authorisation of the veterinary medicinal product Solamocta 697 mg/g Powder for Use in Drinking Water for Chickens, Ducks and Turkeys.
Danish: Den 4. november 2015 gennemførte Det Europæiske Lægemiddelagentur en voldgiftsprocedure efter en uoverensstemmelse blandt medlemsstaterne i Den Europæiske Union (EU) om godkendelsen af lægemidlet Solamocta, pulver til opløsning i drikkevand, 697 mg/g, til kyllinger, ænder og kalkuner.
English: The product is indicated for treatment of infections in chickens, turkeys and ducks caused by bacteria susceptible to amoxicillin.
Danish: Solamocta er indiceret til behandling af kyllinger, kalkuner og ænder for infektioner forårsaget af amoxicillinfølsomme bakterier.
English: Eurovet Animal Health B.V. submitted a marketing authorisation application, under Article 13(3) of Directive 2001/82/EC (i.e. hybrid or mixed application), for Solamocta to the United Kingdom via the decentralised procedure referring to the reference product Amoxinsol 100% w/w Powder for Oral Solution authorised in the United Kingdom.
Danish: Ansøgeren, Eurovet Animal Health B.V., indsendte en ansøgning om markedsføringstilladelse til Det Forenede Kongerige via den decentrale procedure for Solamocta i henhold til artikel 13, stk. 3, i direktiv 2001/82/EF (dvs. en hybrid eller blandet ansøgning) med henvisning til referencelægemidlet Amoxinsol, pulver til oral opløsning, 100 % w/w, der er godkendt i Det Forenede Kongerige.
English: Questions and answers on Solamocta 697 mg/g Powder for Use in Drinking Water for Chickens, Ducks and Turkeys (amoxicillin trihydrate) EMA/23095/2016
Danish: Spørgsmål og svar om Solamocta, pulver til opløsning i drikkevand, 697 mg/g, til kyllinger, ænder og kalkuner (amoxicillintrihydrat) EMA/90151/2016
English: Why was Solamocta 697 mg/g Powder for Use in Drinking Water for Chickens, Ducks and Turkeys reviewed?
Danish: Hvorfor er Solamocta, pulver til opløsning i drikkevand, 697 mg/g, til kyllinger, ænder og kalkuner, blevet gennemgået på ny?
English: Questions and answers on Solamocta 697 mg/g Powder for Use in Drinking Water for Chickens, Ducks and Turkeys (amoxicillin trihydrate)
Danish: Spørgsmål og svar om Solamocta, pulver til opløsning i drikkevand, 697 mg/g, til kyllinger, ænder og kalkuner (amoxicillintrihydrat)
English: What is Solamocta 697 mg/g Powder for Use in Drinking Water for Chickens, Ducks and Turkeys?
Danish: Hvad er Solamocta, pulver til opløsning i drikkevand, 697 mg/g, til kyllinger, ænder og kalkuner?
English: ATC-vet code: QL03AX90.
Danish: ATC-vet-kode: QL03AX90.
English: It usually disappeared spontaneously within 1 week at most.
Danish: Denne forsvandt sædvanligvis spontant inden for højst 1 uge.
English: EXP {month/year}
Danish: EXP{måneder/år}
English: Date of first authorisation: 03/05/2013 Date of last renewal: 20/03/2018
Danish: Dato for første markedsføringstilladelse: 03/05/2013 Dato for seneste fornyelse af markedsføringstilladelse: 20 / 03 / 2018
English: This was demonstrated in a field trial over a period of 2 years.
Danish: Dette blev demonstreret ved et 2-årigt feltstudie.
English: Canarypox recombinants are known to be safe for humans.
Danish: Canarypox rekombinanter er kendt for at være sikre for mennesker.
English: Efficacy of the treatment has not been investigated beyond 2 years following treatment.
Danish: Behandlingens effekt er ikke vurderet ud over en 2-årig periode efter behandling.
English: Treatment course: 4 administrations at 1-week intervals (day 0, day 7, day 14, day 21) followed by 2 administrations at 2-week intervals (day 35, day 49).
Danish: Behandlingsprogram: 4 administrationer med ugentlige intervaller (dag 0, dag 7, dag 14, dag 21) efterfulgt af 2 administrationer med 2 ugers interval (dag 35, dag 49).
English: Efficacy has only been tested in conjunction with surgery and radiotherapy; therefore the treatment should be conducted according to treatment course described in section 4.9.
Danish: Effekten har kun været afprøvet i forbindelse med kirurgi og radioterapi; derfor bør behandlingen udføres i henhold til behandlingsprogrammet beskrevet i punkt 4.9.
English: After two years of study follow-up, Oncept IL-2 treated cats showed a longer median time to relapse (above 730 days) compared to control cats (287 days).
Danish: Efter to års opfølgning viste de katte, der var behandlet med Oncept IL-2, en længere mediantid til recidiv (over 730 dage) sammenlignet med kontrolkattene (287 dage).
English: Pharmacotherapeutic group: Antineoplastic and immunomodulating agents, other immunostimulants.
Danish: Farmakoterapeutisk gruppe: Antineoplastisk og immunmodulerende agens, andre immunostimulanter.
English: As safety and efficacy of repetition of the treatment to treat fibrosarcoma recurrence have not been investigated, repetition of the treatment should be considered by the veterinarian taking into account the benefit-risk balance.
Danish: Da sikkerheden og virkningen ved gentagne behandlinger for at behandle tilbagevendende fibrosarkom ikke er undersøgt, bør gentagen behandling overvejes af dyrlægen under hensyntagen til en benefit/risk vurdering.
English: Start the treatment course the day before radiation therapy, preferably within one month after surgical excision.
Danish: Behandlingsprogrammet påbegyndes dagen før strålebehandling, gerne inden for 1 måned efter kirurgisk indgreb.
English: Moreover feline IL-2 has been shown to have very low biological activity on human leukocytes compared to human IL-2.
Danish: Det er endvidere påvist, at felint IL-2 har meget lav biologisk aktivitet på humane leukocytter sammenlignet med humant IL-2.
English: A moderate local reaction (pain on palpation, swelling, scratching) occurred very commonly in safety studies.
Danish: En moderat lokalreaktion (smerte ved berøring, hævelse, kløe) var meget almindelig i sikkerhedsstudier.
English: In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician.
Danish: I tilfælde af selvinjektion ved hændeligt uheld skal der straks søges lægehjælp, og indlægssedlen eller etiketten bør vises til lægen
English: Lyophilisate: 6 x 1 dose Solvent: 6 x 1 ml
Danish: Tørstof: 6 x 1 dosis Solvens: 6 x 1 ml
English: Solvent for Oncept IL-2
Danish: Solvens til Oncept IL-2
English: EXP {month/year} Use immediately after reconstitution.
Danish: EXP{måneder/år} Anvendes straks efter opløsning.
English: The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals treated displaying adverse reaction(s)) during the course of one treatment) - common (more than 1 but less than 10 animals in 100 animals treated) - uncommon (more than 1 but less than 10 animals in 1,000 animals treated ) - rare (more than 1 but less than 10 animals in 10,000 animals treated) - very rare (less than 1 animal in 10,000 animals treated, including isolated reports).
Danish: Hyppigheden af bivirkninger er defineret som: - Meget almindelige (flere end 1 ud af 10 behandlede dyr, der viser bivirkninger i løbet af en behandling) - Almindelige (flere end 1, men færre end 10 dyr ud af 100 behandlede dyr) - Ikke almindelige (flere end 1, men færre end 10 dyr ud af 1.000 behandlede dyr) - Sjældne (flere end 1, men færre end 10 dyr ud af 10.000 behandlede dyr) - Meget sjældne (færre end 1 dyr ud af 10.000 behandlede dyr, herunder isolerede rapporter)
English: Solvent: clear colourless liquid.
Danish: Solvens: klar farveløs væske.
English: Solvent: Water for injections.
Danish: Solvens: Vand til injektion
English: A decision to use this immunological veterinary medicinal product before or after any other veterinary medicinal product therefore needs to be made on a case by case basis.
Danish: En eventuel beslutning om at anvende dette immunologiske veterinærmedicinske præparat umiddelbart før eller efter brug af et andet lægemiddel til dyr skal derfor tages med udgangspunkt i det enkelte tilfælde.
English: The vaccine strain vCP1338 is a recombinant canarypox virus expressing feline interleukin-2 (IL-2).
Danish: Vaccinestammen vCP1338 er en rekombinant canarypoxvirus, der udtrykker felint interleukin-2 (IL-2).
English: Use of the recommended mode of administration in 5 injection points is important for achieving efficacy of the product; injection in 1 point may lead to reduced efficacy (see section 4.9).
Danish: Det er vigtigt at anvende den anbefalede administrationsmåde med 5 injektionssteder for at opnå effekt af produktet; injektion på kun et injektionssted kan føre til nedsat effekt (see punkt 4.9).
English: Efficacy has not been tested in cats with metastasis or lymph node involvement.
Danish: Effekten har ikke været afprøvet hos katte med metastase eller spredning til lymfeknuder.
English: A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Danish: A. FREMSTILLERE AF DET BIOLOGISK AKTIVE STOF OG FREMSTILLER ANSVARLIG FOR BATCHFRIGIVELSE
English: After reconstitution, each dose of 1 ml contains:
Danish: En dosis på 1 ml indeholder efter opløsning:
English: Oncept IL-2 treatment reduced the risk of relapse, from 6 months after the start of treatment, by approximately 56% after 1 year and 65% after 2 years.
Danish: Oncept IL-2 behandling reducerede risikoen for recidiv, fra 6 måneder efter behandlingsstart, med ca. 56% efter 1 år og 65% efter 2 år.
English: After reconstitution of the lyophilisate with the solvent, shake gently and administer five injections (each approximately 0.2 ml) around the tumour excision site: one injection at each corner and one injection at the centre of a 5 cm x 5 cm square centred on the middle of the surgical scar.
Danish: Omryst forsigtigt efter opløsning af tørstoffet i solvens og indgiv 5 injektioner (hver enkelt på ca. 0,2 ml) omkring det sted, hvor tumor er fjernet: en injektion i hvert hjørne samt en injektion i centrum af en firkant på 5x5 cm, der er centreret omkring midten af det kirurgiske ar.
English: The virus expresses the IL-2 gene at the inoculation site, but does not replicate in the cat.
Danish: Virus afgiver IL-2 genet på inokulationsstedet, men repliceres ikke hos kat.
English: Do not mix with any other veterinary medicinal product, except the solvent supplied for use with the veterinary medicinal product.
Danish: Må ikke blandes med andre lægemidler til dyr undtaget solvens, der leveres til brug med dette veterinærlægemiddel.
English: Marketing authorisation holder: Boehringer Ingelheim Vetmedica GmbH 55216 Ingelheim/Rhein GERMANY
Danish: Indehaver af markedsføringstilladelsen : Boehringer Ingelheim Vetmedica GmbH 55216 Ingelheim/Rhein TYSKLAND
English: Oncept IL-2 injected into the tumour bed thus delivers in situ a low dose of feline interleukin-2, which stimulates antitumour immunity while avoiding toxicity associated with systemic treatment.
Danish: Når Oncept IL-2 injiceres i det primære tumorsted, afgives der således en lav dosis af felint interleukin-2 in situ, der stimulerer antitumor immunitet samtidig med at toksicitet forbundet med systemisk behandling undgås.
English: MANUFACTURER RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. STATEMENT OF THE MRLs
Danish: BILAG II A. FREMSTILLERE AF DET BIOLOGISK AKTIVE STOF OG FREMSTILLER ANSVARLIG FOR BATCHFRIGIVELSE B. BETINGELSER ELLER BEGRÆNSNINGER VEDRØRENDE UDLEVERING OG BRUG C. ANGIVELSE AF MRL-VÆRDIER
English: No information is available on the safety and efficacy of this immunological veterinary medicinal product when used with any other veterinary medicinal product.
Danish: Der foreligger ingen oplysninger om sikkerhed og virkning ved brug af dette immunologiske veterinærmedicinske præparat sammen med andre lægemidler til dyr.
English: After reconstitution use immediately.
Danish: Anvendes umiddelbart efter rekonstituering.
English: In a randomized clinical study, cats from different origins presenting a fibrosarcoma without metastasis or lymph node involvement were included in two groups, one receiving the reference treatment - surgery and radiotherapy - and the other receiving Oncept IL-2 in addition to surgery and radiotherapy.
Danish: Katte af forskellig oprindelse med fibrosarkom, uden metastase eller spredning til lymfeknuder, blev i et randomiseret klinisk studie inkluderet i 2 grupper, en gruppe fik kontrolbehandlingen - kirurgi og radioterapi - og den anden gruppe blev behandlet med Oncept IL-2 som supplement til kirurgi og radioterapi.
English: Specific mechanisms by which immunostimulation induces anti-tumoural activity is not known.
Danish: De specifikke virkningsmekanismer hvorved immunostimulation inducerer antitumor aktivitet er ikke kendte.
English: Transient apathy and fever (above 39.5 °C) occurred commonly in field studies.
Danish: Forbigående apati og feber (>39,5oC) var almindelige i feltstudier.
English: Lyophilisate: whitish homogeneous pellet.
Danish: Tørstof: hvidlig homogen pille.
English: If you notice any side effects, even those not already listed in this package leaflet or you think that the medicine has not worked, please inform your veterinary surgeon
Danish: Dette gælder også bivirkninger, der ikke allerede er anført i denne indlægsseddel, eller hvis du mener, at dette lægemiddel ikke har virket efter anbefalingerne.
English: Collagen hydrolysate Casein hydrolysate Sodium chloride
Danish: Kollagenhydrolysat Caseinhydrolysat Natriumchlorid Dinatriumphosphatdihydrat Kaliumdihydrogenphosphat
English: The safety of the veterinary medicinal product has not been established during pregnancy and lactation.
Danish: Lægemidlets sikkerhed under drægtighed og diegivning er ikke fastlagt.
English: Use of the recommended mode of administration in 5 injection points is important for achieving efficacy of the product; injection in 1 point may lead to reduced efficacy (see section “Dosage for each species, route and method of administration”).
Danish: Det er vigtigt at anvende den anbefalede administrationsmåde med 5 injektionssteder for at opnå effekt af produktet; injektion på kun et injektionssted kan føre til nedsat virkning (Se afsnittet DOSERING FOR HVER DYREART, ANVENDELSESMÅDE OG INDGIVELSESVEJ).
English: Transient apathy and hyperthermia (above 39.5 °C) occurred commonly in field studies.
Danish: Forbigående apati og temperaturforhøjelse (>39,5oC) var almindelige i feltstudier.
English: Immunotherapy to be used in addition to surgery and radiotherapy in cats with fibrosarcoma (2-5 cm diameter) without metastasis or lymph node involvement in order to reduce the risk of relapse and to increase the time to relapse (local recurrence or metastasis).
Danish: Immunoterapi som supplerende behandling til kirurgi og radioterapi hos katte med fibrosarkom (2-5 cm i diameter), hvor der ikke forekommer metastase eller spredning til lymfeknuder, for at nedsætte risiko for recidiv og for at forøge tidsintervallet til recidiv (lokalt forekommende eller metastase).
English: Oncept IL-2 lyophilisate
Danish: Oncept IL-2 tørstof
English: Mild local and/or systemic adverse reactions related to the injection itself may be observed transitorily.
Danish: Ved selvinjektion kan der forbigående iagttages milde lokale og/eller systemiske bivirkninger p.gr.a.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE Cardboard box of 6 vials of lyophilisate and 6 vials of solvent
Danish: OPLYSNINGER, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE Æske med 6 hætteglas tørstof og 6 hætteglas solvens
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Solvent vial
Danish: MINDSTEKRAV TIL OPLYSNINGER PÅ SMÅ INDRE PAKNINGER Solvens hætteglas
English: Shelf life after first opening the immediate packaging: use immediately after reconstitution.
Danish: Opbevaringstid efter rekonstituering: anvendes straks.
English: After the administration of an overdose (10 doses), transient moderate to marked hyperthermia, as well as local reactions (swelling, redness or slight pain, and in some cases, heat at the injection site) may occur.
Danish: Forbigående, moderat til markant temperaturforhøjelse samt lokalreaktioner (hævelse, rødme eller let smerte og i nogle tilfælde varme på injektionsstedet) kan forekomme efter administration af en overdosis (10 doser).
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Lyophilisate vial
Danish: MINDSTEKRAV TIL OPLYSNINGER PÅ SMÅ INDRE PAKNINGER Tørstof hætteglas
English: Cardboard box containing 6 vials of 1 dose of lyophilisate and 6 vials of 1 ml of solvent.
Danish: Æske indeholdende 6 hætteglas à 1 dosis tørstof og 6 hætteglas à 1 ml solvens.
English: Feline interleukin-2 recombinant canarypox virus (vCP1338) ........................................ ≥ 106.0 EAID50
Danish: Felint interleukin-2 rekombinant canarypox virus (vCP1338) ...........................................≥ 106.0 EAID50
English: PACKAGE LEAFLET: Oncept IL-2 lyophilisate and solvent for suspension for injection for cats
Danish: INDLÆGSSEDDEL: Oncept IL-2 tørstof og solvens til injektionsvæske, suspension til kat
English: Feline interleukin-2 recombinant canarypox virus (vCP1338) ......................................... ≥ 106.0 EAID*50 *ELISA infectious dose 50%.
Danish: Felint interleukin-2 rekombinant canarypox virus (vCP1338) .........................................≥ 106.0 EAID*50 *ELISA infektiøs dosis 50%
English: Feline interleukin-2 recombinant canarypox virus (vCP1338) ....................................... ≥ 106.0 EAID*50 *ELISA infectious dose 50%.
Danish: Felint interleukin-2 rekombinant canarypox virus (vCP1338) ....................................... ≥ 106.0 EAID*50 *ELISA infektiøs dosis 50 %
English: Lyophilisate and solvent for suspension for injection.
Danish: Tørstof og solvens til injektionsvæske, suspension.
English: Oncept IL-2 lyophilisate and solvent for suspension for injection for cats
Danish: Oncept IL-2 tørstof og solvens til injektionsvæske, suspension til kat.
English: Efficacy has only been tested in conjunction with surgery and radiotherapy; therefore the treatment should be conducted according to treatment course described in section “Dosage for each species, route and method of administration”.
Danish: Derfor bør behandlingen udføres i overensstemmelse behandlingsprogrammet som er beskrevet i afsnittet ”DOSERING FOR HVER DYREART, ANVENDELSESMÅDE OG INDGIVELSESVEJ” Effekten har ikke været afprøvet hos katte med metastase eller spredning til lymfeknuder.
English: Type I glass vial with a butyl elastomer closure, sealed with an aluminium cap. Cardboard box of 6 vials of 1 dose of lyophilisate and 6 vials of 1 ml of solvent.
Danish: Type I glas med en butylelastomerprop, forseglet med en aluminiumshætte.
English: Herbal medicine: summary for the public
Danish: Plantelægemiddel: sammendrag til offentligheden
English: Passion flower EMA/275240/2014
Danish: Passionsblomst EMA/275240/2014
English: However, the low number of patients involved and other serious shortcomings in the design of the studies prevented any firm conclusions being drawn.
Danish: På baggrund af det lave antal deltagende patienter og andre alvorlige mangler ved undersøgelsernes udformning, kunne der dog ikke drages endelige konklusioner ud fra disse undersøgelser.
English: Passion flower
Danish: Passionsblomst
English: Passion flower medicines should only be used in adults and adolescents over the age of 12 years.
Danish: Lægemidler indeholdende passionsblomst bør kun anvendes hos voksne og børn over 12 år.
English: What is passion flower?
Danish: Hvad er passionsblomst?
English: Passion flower preparations may also be found in combination with other herbal substances in some herbal medicines.
Danish: Tilberedninger af passionsblomst findes desuden kombineret med andre droger i visse plantelægemidler.
English: Information on the use and licensing of passion flower medicines in EU Member States should be obtained from the relevant national authorities.
Danish: Oplysninger om europæisk anvendelse og godkendelse af lægemidler, der indeholder passionsblomst, skal indhentes fra de relevante nationale myndigheder i EU's medlemsstater.
English: Passion flower is the common name for the above-ground parts of the plant Passiflora incarnata L. The HMPC conclusions only cover passion flower preparations which are obtained by comminuting (reducing into tiny pieces) or powdering the dried above-ground parts or as dry and liquid extracts.
Danish: Passionsblomst er det almindelige navn for de overjordiske dele af planten Passiflora incarnata L. HMPC's konklusioner omfatter kun tilberedninger af passionsblomst, som fremstilles ved findeling eller pulverisering af plantens overjordiske dele eller som tørre eller flydende ekstrakter.
English: Any applications for the licensing of medicines containing passion flower have to be submitted to the national authorities responsible for medicinal products, which will assess the application for the herbal medicine and take into account the scientific conclusions of the HMPC.
Danish: Ansøgninger om godkendelse af lægemidler, der indeholder , skal indsendes til de nationale lægemiddelmyndigheder, som vurderer ansøgningen om plantelægemidlet og tager hensyn til HMPC's videnskabelige konklusioner.