FrancophonIA/ELRC3.0 huggingface dataset:
English: One mL solution in a sterile, single use pre-filled pen made from type I glass with staked 29-gauge ½-inch (12.7 mm) stainless steel needle, rigid needle shield, and Fluorotec-coated stopper in a pre-filled pen.
Danish: 1 mL opløsning i en steril, præ-fyldt pen til engangsbrug, fremstillet af type I-glas med en fastgjort 29-gauge, 0,5 tommer (12,7 mm) kanyle af rustfrit stål, fast kanyleskjold og Fluorotec-belagt stempelprop i en præ-fyldt pen.
English: Do not stop treatment with Fasenra unless your doctor advises you to. Interrupting or stopping the treatment with Fasenra may cause your asthma symptoms and attacks to come back.
Danish: Afbrydelse eller standsning af behandlingen med Fasenra kan medføre, at dine astmasymptomer og anfald kommer tilbage.
English: Step 9 - Check the injection site
Danish: Trin 9 - Tjek injektionsstedet
English: Trial 1 & 2
Danish: Studie 1 & 2
English: Fasenra can potentially cause serious allergic reactions.
Danish: Vær opmærksom på tegn på alvorlige, allergiske reaktioner Fasenra kan potentielt forårsage alvorlige, allergiske reaktioner.
English: Peel off the entire lid from the plastic tray.
Danish: Træk hele låget af plastbakken.
English: Based on population pharmacokinetic analysis, baseline hepatic function biomarkers (ALT, AST, and bilirubin) had no clinically relevant effect on benralizumab clearance.
Danish: Ifølge en farmakokinetisk populationsanalyse havde leverfunktionens baseline-biomarkører (ALAT, ASAT og bilirubin) ingen klinisk relevant virkning på benralizumabs clearance.
English: Each Fasenra Pen contains 1 dose of Fasenra that is for one-time use only.
Danish: Hver Fasenra Pen indeholder 1 dosis Fasenra, der kun er til engangsbrug.
English: If you are breast-feeding or plan to breast-feed, talk to your doctor.
Danish: Hvis du ammer eller planlægger at amme, skal du kontakte din læge.
English: Patients that entered Trial 4 from predecessor Trials 1 and 2 with baseline blood eosinophil counts ≥300 cells/μL who were taking high-dose ICS.
Danish: Patienter, der deltog i studie 4 fra de tidligere studier 1 og 2 med baseline eosinofiltal i blodet ≥300 celler/μl og som tog høj dosis ICS.
English: Clear to opalescent, colourless to yellow solution and may contain translucent or white to off-white particles.
Danish: Klar til opaliserende, farveløs til gul opløsning, som kan indeholde halvgennemsigtige eller hvide til offwhite partikler.
English: Mean baseline (SD) Change from baseline (SD) ACQ-6
Danish: Gennemsnitlig baseline (SD) Ændring fra baseline (SD) ACQ-6
English: Do not inject Fasenra if the liquid is cloudy, discoloured, or contains large particles.
Danish: Injicer ikke Fasenra, hvis opløsningen er uklar, misfarvet eller indeholder store partikler.
English: • Put your used pre-filled syringe in a puncture-resistant sharps container right away after use.
Danish: • Kassér den brugte sprøjte i en kanylebeholder umiddelbart efter brug.
English: Each Fasenra pre-filled syringe contains 1 dose of Fasenra that is for one-time use only.
Danish: Hver Fasenra præ-fyldt injektionssprøjte indeholder 1 dosis Fasenra, der kun er til engangsbrug.
English: OUTER CARTON- PRE-FILLED PEN
Danish: YDRE KARTON - FYLDT PEN
English: Fasenra is available in a pack containing 1 pre-filled syringe.
Danish: Fasenra findes i en pakning med 1 fyldt injektionssprøjte.
English: One mL solution in a single-use pre-filled syringe made from type I glass with a staked 29-gauge ½-inch (12.7 mm) stainless steel needle, rigid needle shield, and Fluorotec-coated plunger stopper in a passive safety device.
Danish: 1 mL opløsning i en fyldt injektionssprøjte til engangsbrug fremstillet af type I-glas med en fastgjort 29-gauge, 0,5 tommer (12,7 mm), kanyle af rustfrit stål og fast kanyleskjold og Fluorotec-belagt stempelprop i en passiv sikkerhedsanordning.
English: Mean baseline (SD) Change from baseline (SD) AQLQ(S)+12
Danish: Gennemsnitlig baseline (SD) Ændring fra baseline (SD) AQLQ(S)+12
English: Excipients: histidine, histidine hydrochloride monohydrate, trehalose dihydrate, polysorbate 20, water for injections.
Danish: Hjælpestoffer: histidin, histidinhydrochloridmonohydrat, trehalosedihydrat, polysorbat 20, vand til injektionsvæsker.
English: The other ingredients are histidine, histidine hydrochloride monohydrate, trehalose dihydrate, polysorbate 20 and water for injections.
Danish: - Øvrige indholdsstoffer: histidin, histidinhydrochloridmonohydrat, trehalosedihydrat, polysorbat 20, vand til injektionsvæsker.
English: Mean baseline (SD) Change from baseline (SD)
Danish: Gennemsnitlig baseline (SD) Ændring fra baseline (SD)
English: Step 6 - Pull off the needle cover
Danish: Trin 6 - Træk nålehætten af
English: Exacerbation rate Difference Rate ratio (95% CI) Pre-bronchodilator FEV1 mean change Difference (95% CI)
Danish: Frekvensratio (95 % CI) Præ-bronkodilatator FEV1 (L) Gennemsnitlig ændring Forskel (95 % CI)
English: What Fasenra looks like and contents of the pack Fasenra is a solution in a clear glass syringe.
Danish: Fasenra er en opløsning i en klar glassprøjte.
English: Store in the original package to protect from light.
Danish: Opbevares i den originale yderpakning for at beskytte mod lys.
English: The Fasenra Pen may be kept at room temperature up to 25°C for a maximum of 14 days.
Danish: Fasenra Pen kan opbevares ved stuetemperatur op til 25 °C i højst 14 dage.
English: Blood eosinophil count ≥300 cells/μL
Danish: Eosinofiltal i blodet ≥300 celler/μl n = 267
English: Total asthma symptom score Mean baseline
Danish: Total astmasymptomscore Gennemsnitlig baseline Forbedring fra baseline
English: No benralizumab-related impairment was observed in reproductive parameters of male and female cynomolgus monkeys.
Danish: Der blev ikke observeret nogen benralizumab-relateret negativ påvirkning af reproduktionspara-metrene hos han- og huncynomolgusaber.
English: Blood eosinophil count <300 cells/μL
Danish: Eosinofiltal i blodet <300 celler/μl n =131
English: For Subcutaneous Injection Single-use Pre-filled Pen
Danish: Til subkutan injektion Præ-Fyldt pen til engangsbrug
English: Τηλ: +357 22490305
Danish: Αλέκτωρ Φαρµακευτική Λτδ Τηλ: +357 22490305
English: After proper training in the subcutaneous injection technique and education about signs and symptoms of hypersensitivity reactions (see section 4.4), patients with no known history of anaphylaxis or their caregivers may administer Fasenra if their physician determines that it is appropriate, with medical follow-up as necessary.
Danish: 4.4), kan patienter uden kendt anamnese med anafylaksi eller deres omsorgspersoner administrere Fasenra, hvis lægen finder, at det er hensigtsmæssigt, med medicinsk opfølgning efter behov.
English: Viewing window
Danish: Vindue Nål
English: Trial 1
Danish: Studie 1
English: Monoclonal antibodies, such as benralizumab, are transported across the placenta linearly as pregnancy progresses; therefore, potential exposure to a fetus is likely to be greater during the second and third trimester of pregnancy.
Danish: Monoklonale antistoffer, såsom benralizumab, transporteres over placenta linært efterhånden som graviditeten skrider frem.
English: Rate ratio (95% CI) p-value
Danish: Frekvensratio (95 % CI) p-værdi
English: Solution for injection 1 pre-filled pen
Danish: Injektionsvæske, opløsning 1 præ-fyldt pen
English: Fasenra may be kept at room temperature up to 25°C for a maximum of 14 days.
Danish: Fasenra kan opbevares ved stuetemperatur op til 25 °C i maksimalt 14 dage.
English: What Fasenra is and what it is used for What you need to know before you use Fasenra How to use Fasenra Pen Possible side effects
Danish: Det skal du vide, før du begynder at bruge Fasenra Sådan skal du bruge Fasenra Pen Bivirkninger
English: Tell your doctor if you are taking, have recently taken or might take any other medicines before using Fasenra.
Danish: Brug af anden medicin sammen med Fasenra Fortæl det altid til lægen, hvis du bruger anden medicin eller har gjort det for nylig før du får Fasenra.
English: Keep the pre-filled pen in the outer carton in order to protect from light.
Danish: Opbevar den præ-fyldte pen i den originale yderpakning for at beskytte mod lys.
English: Fasenra 30 mg injection benralizumab SC
Danish: Fasenra 30 mg injektionsvæske benralizumab s.c.
English: Your Fasenra Pen
Danish: Din Fasenra Pen
English: Fasenra 30 mg injection benralizumab Subcutaneous use
Danish: Fasenra 30 mg injektionsvæske benralizumab subkutan anvendelse
English: Fasenra is for single use only.
Danish: Fasenra er til éngangsbrug.
English: - If you have any further questions, ask your doctor, pharmacist or nurse.
Danish: Er du i tvivl, så spørg lægen, sygeplejersken eller apotekspersonalet.
English: What Fasenra Pen contains
Danish: Fasenra Pen indeholder
English: Trial 2
Danish: Studie 2
English: PRE-FILLED PEN LABEL
Danish: ETIKET PÅ FYLDT PEN
English: Similar maintenance of effect was observed throughout Trial 4 in lung function, ACQ-6 and AQLQ(S)+12 (Table 7).
Danish: Lignende vedligeholdelse af effekt på lungefunktion, ACQ-6 og AQLQ(S)+12 blev observeret gennem studie 4 (tabel 7).
English: Carefully pull the cap straight off with your other hand.
Danish: Hold Fasenra Pen med én hånd, og træk hætten lige af med den anden hånd.
English: The syringe may be kept at room temperature up to 25°C for a maximum of 14 days.
Danish: Injektionssprøjten kan opbevares ved stuetemperatur op til 25 °C i højst 14 dage.
English: Description of selected adverse reaction
Danish: Beskrivelse af udvalgte bivirkninger
English: Difference (95% CI) AQLQ(S)+12
Danish: Gennemsnitlig baseline Forbedring fra baseline Forskel (95% CI) AQLQ(S)+12
English: • shake your pre-filled syringe
Danish: • omryste din fyldte injektionssprøjte
English: No change or no decrease in OCS
Danish: Ingen ændring eller ingen reduktion af OCS Odds ratio (95 % CI)
English: Pre-filled pen Each pre-filled pen contains 30 mg benralizumab* in 1 mL.
Danish: Præ-fyldt pen Hver præ-fyldt pen indeholder 30 mg benralizumab* i 1 mL.
English: For Subcutaneous Injection Single-use Pre-filled Syringe
Danish: Til subkutan injektion Præ-fyldt injektionssprøjte til engangsbrug
English: It should be injected into the thigh or abdomen.
Danish: Der skal injiceres i lår eller mave.
English: How to use Fasenra Pen
Danish: Sådan skal du bruge Fasenra Pen
English: Solution for Injection in Pre-filled Pen Benralizumab
Danish: Injektionsvæske, opløsning i præ-fyldt pen Benralizumab
English: Fasenra 30 mg solution for injection in pre-filled pen benralizumab
Danish: Fasenra 30 mg injektionsvæske, opløsning i præ-fyldt pen benralizumab
English: Improvement from baseline Difference (95% CI) p-value
Danish: Gennemsnitlig baseline Forbedring fra baseline Forskel (95% CI)
English: What Fasenra contains
Danish: Fasenra indeholder:
English: Step 9 - Dispose the used pre-filled syringe
Danish: Trin 9 - Kassér den brugte injektionssprøjte
English: How Fasenra works
Danish: Hvordan virker Fasenra
English: Syringe body
Danish: Sprøjtecylinder
English: However, in the offspring of monkeys dosed while pregnant, there was a reduction in eosinophils.
Danish: Der var hos afkom af aber imidlertid en reduktion af eosinofiltallet ved dosering under drægtigheden.
English: One pre-filled pen contains 30 mg benralizumab in 1 mL.
Danish: En præ-fyldt pen indeholder 30 mg benralizumab i 1 mL
English: Step 3 - Check the liquid
Danish: Trin 3 - Tjek opløsningen
English: Trial 4
Danish: Studie 4
English: How to use Fasenra
Danish: Sådan skal du bruge Fasenra
English: Step 2 - Prepare to use your pre-filled syringe
Danish: Trin 2 - Forberedelse til brug af fyldt injektionssprøjte
English: LIST OF EXCIPIENTS
Danish: Eksacerbationsstudier
English: Pack containing 1 single-use pre-filled syringe.
Danish: Pakningen indeholder 1 fyldt injektionssprøjte til engangsbrug.
English: Do not re-cap the pre-filled syringe.
Danish: Sæt ikke nålehætten tilbage på injektionssprøjten.
English: One pre-filled pen of 1 mL solution contains 30 mg benralizumab.
Danish: Én præ-fyldt pen med 1 mL opløsning indeholder 30 mg benralizumab.
English: Fasenra 30 mg solution for injection in pre-filled syringe Fasenra 30 mg solution for injection in pre-filled pen
Danish: Fasenra 30 mg injektionsvæske, opløsning i præ-fyldt pen.
English: Keep the pre-filled syringe in the outer carton in order to protect from light.
Danish: Opbevar den præ-fyldte injektionssprøjte i den originale yderpakning for at beskytte mod lys.
English: Solution for Injection in Pre-filled Syringe Benralizumab
Danish: Injektionsvæske, opløsning i præ-fyldt injektionssprøjte Benralizumab
English: Check with your doctor, nurse or pharmacist if you are not sure.
Danish: Spørg lægen, apotekspersonalet eller sundhedspersonalet, hvis der er noget, du er i tvivl om.
English: Pre-filled syringe Each pre-filled syringe contains 30 mg benralizumab* in 1 mL.
Danish: Præ-fyldt injektionssprøjte Hver præ-fyldte injektionssprøjte indeholder 30 mg benralizumab* i 1 mL.
English: Change from baseline for lung function, ACQ-6, and AQLQ(S)+12
Danish: Ændring i lungefunktion, ACQ-6 og AQLQ(S)+12 a i forhold til baseline
English: One pre-filled syringe of 1 mL solution contains 30 mg benralizumab.
Danish: Én fyldt sprøjte med 1 mL indeholder 30 mg benralizumab.
English: • 1 puncture-resistant sharps container.
Danish: • 1 kanylebeholder.
English: Alcohol wipe
Danish: Spritserviet
English: Paediatric
Danish: Dosering
English: Rate ratio (95% CI)
Danish: Frekvensratio (95 % CI)
English: • pharyngitis (sore throat)
Danish: • halsbetændelse (ondt i halsen)
English: One pre-filled syringe contains 30 mg benralizumab in 1 mL.
Danish: En fyldt injektionssprøjte indeholder 30 mg benralizumab i 1 mL
English: Posology
Danish: Stempelhoved
English: PRE-FILLED SYRINGE LABEL
Danish: Præ-fyldt injektionssprøjte
English: Trial 3
Danish: Studie 3
English: Needle Guard
Danish: Kanylebeholder
English: Your Fasenra pre-filled syringe
Danish: Din Fasenra fyldte injektionssprøjte
English: Caregiver site only
Danish: Kun omsorgsperson her
English: Pre-filled syringe
Danish: • nældefeber
English: Fasenra 30 mg solution for injection in pre-filled syringe benralizumab
Danish: Fasenra 30 mg injektionsvæske, opløsning i fyldt injektionssprøjte benralizumab
English: Exacerbation rate
Danish: Nedsat leverfunktion
English: What Fasenra is and what it is used for What you need to know before you use Fasenra How to use Fasenra
Danish: Det skal du vide, før du begynder at bruge Fasenra Sådan skal du bruge Fasenra Bivirkninger
English: OUTER CARTON- PRE-FILLED SYRINGE
Danish: YDRE KARTON - FYLDT INJEKTIONSSPRØJTE
English: FEV1 mean change Difference (95% CI) Baseline of 3 or more exacerbations
Danish: Præ-bronkodilatator FEV1 (L) Gennemsnitlig baseline Forbedring fra baseline Forskel (95% CI) p-værdi
English: Tel: +46 8 553 26 000
Danish: AstraZeneca AB Tel: +46 8 553 26 000
English: Finger flange
Danish: Fingerflange
English: Cap
Danish: Hætte
English: Each film-coated tablet contains 300 mg of abacavir as abacavir sulphate, 150 mg lamivudine and 300 mg zidovudine
Danish: Hver filmovertrukken tablet indeholder 300 mg abacavir (som sulfat), 150 mg lamivudin og 300 mg zidovudin
English: Blister (PVC/PCTFE/PVCAl/Paper
Danish: Blisterpakning (PVC/PCTFE/PVCAl/Papir)
English: Blister (opaque white PCTFE/PVCAl
Danish: Blisterpakning (uigennemsigtig, hvid PCTFE/PVCAl)
English: Pharmaceutical form
Danish: Styrke Lægemiddelform Administration Emballage
English: Bottle (HDPE)
Danish: Beholder (HDPE) 60 tabletter
English: No information available
Danish: Ingen tilgængelige oplysninger
English: 1 Not for decoquinate.
Danish: 1 Ikke til decoquinat.
English: Member State/EEA
Danish: Medlemsstat /EØS
English: They are well distributed in the body after administration and are active against a wide range of microorganisms.
Danish: De fordeles godt i kroppen efter indgift og er aktive mod en bred vifte af mikroorganismer.
English: The last analysis in late 2008 of the success of the agreed approach showed that the CVMP recommendations had not been fully implemented yet and that further action was necessary.
Danish: Den seneste analyse af resultaterne af den aftalte fremgangsmåde i slutningen af 2008 viste, at CVMP's anbefalinger endnu ikke var fuldt implementeret, og at det var nødvendigt at foretage yderligere foranstaltninger.
English: Applicant/ Marketing Authorisation Holder
Danish: Ansøger/indehaver af markedsførings-tilladelse
English: Since then additional fluoroquinolone molecules have been authorised and a number of different veterinary medicines are now available on the market.
Danish: Siden da er yderligere fluoroquinolonmolekyler blevet godkendt, og der er nu en række forskellige veterinærlægemidler på markedet.
English: In the light of the increase in bacterial resistance to antimicrobial substances, the European Council has called upon the European Commission and Member States to take steps as regards food- and animal-borne resistance to promote the prudent use of antimicrobials.
Danish: I lyset af stigningen i bakteriel resistens over for antimikrobielle stoffer har Rådet bedt EuropaKommissionen og medlemsstaterne om at tage skridt vedrørende levnedsmiddel- og dyrebåren resistens for at fremme forsigtig anvendelse af antimikrobielle midler.
English: Moreover the indications for use of the products are not the same in all countries and marketing authorisations can differ between countries.
Danish: Desuden er midlernes terapeutiske indikationer ikke de samme i alle lande, og markedsføringstilladelserne kan være forskellige i de forskellige lande.
English: Therefore, further action is required in order to ensure that adequate prudent use warnings are included.
Danish: Der er derfor behov for at foretage sig yderligere for at sikre, at der medtages tilstrækkelige advarsler om forsigtig brug.
English: The number of authorised products containing (fluoro) quinolones varies between different European Union countries.
Danish: Antallet af godkendte produkter, som indeholder (fluoro)quinoloner, varierer i de forskellige EU-lande.
English: Exotic Animals (small mammals, reptiles, avian species)
Danish: Eksotiske dyr (små pattedyr, reptiler, fuglearter)
English: In order to evaluate the situation concerning the existing prudent use warnings in the concerned products the CVMP agreed to define the following groups: Group 1.
Danish: For at evaluere situationen vedrørende eksisterende advarsler om forsigtig brug i de berørte produkter vedtog CVMP at definere følgende grupper: Gruppe 1.
English: List of the names, strengths of the veterinary medicinal products, animal species, route of administration, recommended dose and applicants/marketing authorisation holders in the member states
Danish: Liste over veterinærlægemidlernes navne, styrke, dyrearter, indgivelsesvej, anbefalet dosis og ansøgere/indehavere af markedsføringstilladelse i medlemsstaterne
English: The older generation of quinolones were licensed for use in food producing animals at the beginning of the 1980's and the first fluoroquinolone (enrofloxacin) during the late 1980's and early 1990's.
Danish: Den ældre generation af quinoloner blev godkendt til brug hos dyr til levnedsmiddelproduktion i starten af 1980'erne og det første fluoroquinolon (enrofloxacin) i slutningen af 1980'erne og begyndelsen af 1990'erne.
English: However, following the adoption of the Commission's Decision on this referral, Member States should identify and review information on the outstanding products and consider whether any action is appropriate as regards products authorised by them, and should act accordingly.
Danish: Efter vedtagelse af Kommissionens afgørelse om denne indbringelse bør medlemsstaterne identificere og gennemgå oplysninger om de resterende lægemidler og overveje, om der skal træffes yderligere foranstaltninger med hensyn til lægemidler, de har godkendt, og handle i overensstemmelse hermed.
English: (Fluoro) quinolones for use in food-producing species have been authorised in the European Union via the national, mutual recognition and centralised procedures.
Danish: (Fluoro)quinoloner til arter til levnedsmiddelproduktion er godkendt i EU via nationale procedurer, procedurer for gensidig anerkendelse og centraliserede procedurer.
English: Romania CEVASA Cervantes 1543/45
Danish: Rumænien CEVASA Cervantes 1543/45
English: Denmark Vetrepharm A/S Øgelundvej 7
Danish: Vetrepharm A/S Øgelundvej 7
English: Agroseed-Candilidis Parapleuros Attikis Road Exodos 1,Thesi Xiro Pigadi 19600 Mandra Attikis GREECE
Danish: Grækenland Agroseed-Candilidis Parapleuros Attikis Road Exodos 1,Thesi Xiro Pigadi 19600 Mandra Attikis GREECE
English: Overall summary of the scientific evaluation of veterinary medicinal products containing (fluoro)quinolones (see annex I)
Danish: Samlet resumé af den faglige vurdering af veterinærlægemidler indeholdende (fluoro)quinoloner (se bilag I)
English: The warnings to be included in the Summary of the Product Characteristics and Package Leaflet should be reviewed to reflect the text set out in Annex III.
Danish: De advarsler, som skal medtages i produktresuméet og indlægssedlen, skal gennemgås for at afspejle den tekst, som er anført i bilag III.
English: Romania Veterina Ltd. Svetonedeljska 2, Kalinovica 10436 Rakov Potok CROATIA
Danish: Rumænien Veterina Ltd. Svetonedeljska 2, Kalinovica 10436 Rakov Potok CROATIA
English: • there is a need for risk management interventions regarding the use of (fluoro)quinolones for humans and animals;
Danish: • der er behov for intervention med henblik på risikostyring med hensyn til brug af (fluoro)quinoloner til mennesker og dyr
English: Ceva Saúde Animal - Produtos Farmacêuticos e Imunológicos, Lda.
Danish: Ceva Saúde AnimalProdutos Farmacêuticos e Imunológicos, Lda.
English: Romania Pasteur - Filiala Filipesti Srl Str. Principala nr. 944
Danish: Rumænien Pasteur - Filiala Filipesti Srl Str. Principala nr. 944
English: The European Commission clarified on 30 July 2009 that prudent use warnings already contained in the product literature of the concerned products could be maintained even if they were not an exact reproduction of the CVMP recommendation provided that they convey the same key messages.
Danish: Europa-Kommissionen klarlagde den 30. juli 2009, at advarslerne om forsigtig brug, som allerede fandtes i produktlitteraturen til de berørte produkter, kunne bevares, selvom de ikke var en nøjagtig gengivelse af CVMP's anbefalinger, forudsat at de indeholdt de samme budskaber.
English: Quinolones represent a class of antimicrobials that is most important in the treatment of severe and invasive infections in humans and animals and are therefore of special interest for public and animal health.
Danish: Quinoloner udgør en klasse af antimikrobielle midler, som er vigtigst til behandling af svære og invasive infektioner hos mennesker og dyr og derfor af særlig interesse for folke- og dyresundheden.
English: Romania Ceva Santé Animale Romania SRL
Danish: Rumænien Ceva Santé Animale Romania SRL
English: Hungary VMD Állatgyógyászati Kft. Közraktár u. 22/b.
Danish: VMD Állatgyógyászati Kft. Közraktár u. 22/b.
English: Hungary Bayer Hungária Kft. Alkotás u. 50.
Danish: Bayer Hungária Kft. Alkotás u. 50.
English: • the inclusion of specific warnings in the Summary of the Product Characteristics and Package Leaflet of the concerned products is intended to encourage prudent use and help maintain the positive benefit:risk balance for (fluoro)quinolone products;
Danish: • medtagelse af specifikke advarsler i produktresuméet og i indlægssedlen til de berørte produkter har til formål at opmuntre til forsigtig brug og hjælpe med at opretholde den positive benefit:riskbalance for (fluoro)quinolonprodukter
English: New Vet Hellas AE Fleming 15
Danish: Grækenland New Vet Hellas AE Fleming 15
English: In addition, for 83 products no prudent use warnings are included in the Summary of the Product Characteristics and therefore further action is required in order to ensure that adequate prudent use warnings in line with the recommendations from the Committee are included.
Danish: Derudover var der for 83 lægemidlers vedkommende ingen advarsler om forsigtig brug i produktresuméet, og det er derfor nødvendigt at foretage sig yderligere for at sikre, at der medtages tilstrækkelige advarsler om forsigtig brug i overensstemmelse med udvalgets anbefalinger.