FrancophonIA/ELRC3.0 huggingface dataset:
English: STATEMENT OF ACTIVE SUBSTANCE(S) One pre-filled syringe of 3 ml solution contains 3 mg of ibandronic acid (as sodium monohydrate).
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER En fyldt injektionssprøjte, med 3 ml opløsning, indeholder 3 mg ibandronsyre (som natriummonohydrat).
English: Patients must receive supplemental calcium and vitamin D (see section 4.4 and section 4.5)
Danish: Patienten skal have et calcium- og -vitamin D-tilskud (se pkt.
English: Bondenza 3 mg solution for injection in pre-filled syringes is a solution for intravenous injection by a health care professional.
Danish: Bondenza injektion fås som en 3 mg farveløs, klar opløsning i en fyldt injektionssprøjte til intravenøs injektion af en læge eller anden sundhedsperson.
English: - not enough calcium and vitamin D in the diet - smoking cigarettes, or drinking too much alcohol - not enough walking or other weight-bearing exercise - a family history of osteoporosis
Danish: Andre forhold, som kan øge risikoen for knoglebrud, er: - for lidt kalk og vitamin D i kosten - cigaretrygning eller for meget alkohol - ikke nok gåture eller anden vægtbærende aktivitet - osteoporose i familien
English: Breast-feeding
Danish: Ibandronsyre
English: REMINDER STICKERS TEXT
Danish: TEKST PÅ HUSKESEDLERNE
English: If your next scheduled dose is more than 7 days away… You should take one tablet the next morning after the day you remember; then, continue taking one tablet once a month on the scheduled days you've marked on your calendar.
Danish: Derefter skal du fortsætte med at tage én tablet én gang om måneden på de planlagte dage, som du har markeret i din kalender.
English: Lumbar spine L2-L4 BMD 3.9 [3.4, 4.3]
Danish: Lumbal L2-L4
English: The dose of Bondenza is one tablet once a month.
Danish: PLANLÆGNING AF HVORNÅR BONDENZA SKAL INDTAGES Doseringen af Bondenza er én tablet om måneden.
English: Due to the limited clinical experience, Bondenza is not recommended in patients with severe renal impairment (see section 4.2 and section 4.4) .
Danish: På grund af begrænsede erfaringer, kan Bondenza ikke anbefales til patienter med svært nedsat nyrefunktion (se pkt.
English: Bondenza injection is not recommended for use in patients who have a serum creatinine above 200 μmol/l (2.3 mg/dl) or who have a creatinine clearance (measured or estimated) below 30 ml/min, because of limited clinical data available from studies including such patients (see section 4.4 and section 5.2).
Danish: behandling med Bondenza ikke anbefales til patienter med serumkreatinin højere end 200 μmol/l (2,3 mg/dl) eller med en kreatininclearance mindre end 30 ml/min (se pkt.
English: • bone pain
Danish: PSUR'er
English: Roche Farma, S.A. Tel: +34 - 94 481 83 00
Danish: Tel: +34 - 94 481 83 00
English: Other things that can increase the risk of fractures include:
Danish: - De øvrige indholdsstoffer er:
English: This includes any possible side effects not listed in this leaflet.
Danish: De alvorligste bivirkninger er nævnt først inden for hver gruppe.
English: Bondenza
Danish: Amning
English: Lactose monohydrate Povidone
Danish: Lactosemonohydrat
English: PLANNING WHEN TO TAKE BONDENZA
Danish: Når du fortsat får Bondenza
English: PSURs
Danish: Crospovidon
English: The Reference Member State was Ireland and the Concerned Member States were Austria, Bulgaria, Denmark, Spain, Finland, France, Hungary, Iceland, the Netherlands, Norway, Poland, Portugal, Romania, Slovenia and Sweden.
Danish: Referencemedlemsstaten var Irland, og de berørte medlemsstater var Østrig, Bulgarien, Danmark, Spanien, Finland, Frankrig, Ungarn, Island, Nederlandene, Norge, Polen, Portugal, Rumænien, Slovenien og Sverige.
English: • During this referral procedure in Ireland the marketing authorisation of the reference product
Danish: • Under denne henvisningsprocedure er markedsføringstilladelsen i Irland for referenceproduktet
English: The product has claims for persistent efficacy ranging from 21 to 49 days.
Danish: Produktet påberåbes at virke i en periode på 21 til 49 dage.
English: During the procedure, there was disagreement between the Reference Member State and Concerned Member States on the data presented to support the environmental risk assessment.
Danish: Under denne procedure var der uenighed mellem referencemedlemsstaten og de berørte medlemsstater vedrørende de forelagte oplysninger til støtte for miljørisikovurderingen.
English: However, this study is not available and cannot be requested in this referral.
Danish: En sådan undersøgelse foreligger imidlertid ikke, og der kan ikke stilles krav herom i forbindelse med denne henvisning.
English: The parent drug accounted for 79% of the total radioactive faecal residue.
Danish: Moderstoffet udgjorde 79 % af den samlede radioaktive restkoncentration i fæces.
English: 1 During the decentralised procedure it was agreed that the authorisation of the generic product under the name "Dectomax" will not be issued until the reference product under the name "Dectomax" has either been withdrawn or renamed.
Danish: 1 Under den decentrale procedure blev det aftalt, at godkendelsen for det generiske produkt under navnet "Dectomax" ikke vil blive udstedt, før referenceproduktet under navnet "Dectomax" enten er trukket tilbage eller har fået ændret navnet.
English: Therefore, risk mitigation measures are considered necessary, as specified in the product information.
Danish: Det anses derfor for nødvendigt med foranstaltninger til risikonedsættelse som angivet i produktinformationen.
English: In general terms, as for the benefits, that except for the risks identified in particular by the referral (ERA) all other risks are expected to be the same as for the reference product and have not been discussed in any detail by CVMP.
Danish: Ligesom for fordelene gælder det generelt, at bortset fra risici, der særligt er påpeget ved henvisningen (ERA), forventes alle øvrige risici at svare til referenceproduktets og har ikke været drøftet i detaljer af CVMP.
English: The application was submitted in accordance with the Article 13(1) of the Directive 2001/82/EC (i.e. an application for a generic product).
Danish: Ansøgningen blev indgivet i overensstemmelse med artikel 13, stk. 1, i direktiv 2001/82/EF (dvs. en ansøgning for et generisk produkt).
English: The log Pow of 4.4 can therefore only be considered as an indicator of the actual value.
Danish: Værdien 4,4 for log Pow kan derfor kun anses for at være vejledende i forhold til den faktiske værdi.
English: The following two changes to the initial application that were made during the decentralised procedure and the CVMP referral procedure should be noted:
Danish: Det skal bemærkes, at der blev foretaget følgende to ændringer i den oprindelige ansøgning under den decentrale procedure og henvisningsproceduren:
English: In the first case, the risk to daphnids could not be ruled out by performing several PEC refinements for the direct excretion scenario.
Danish: I det første tilfælde kunne risiko over for dafnier ikke udelukkes gennem udførelse af flere nærmere PEC-bestemmelser for scenariet med direkte udskillelse.
English: The supplementary data provided did not allow ruling out a medium to longterm risk to dung insects.
Danish: På grundlag af de forelagte supplerende data kunne det ikke udelukkes, at der er mellemlangsigtet til langsigtet risiko over for insekter i gødning.
English: Therefore no PEC refinement based on metabolism is possible, the risk assessment is based on total residues.
Danish: Der kan derfor ikke foretages en nærmere bestemmelse af PEC-værdier på grundlag af metabolisering, hvorfor risikovurderingen er baseret på totale restkoncentrationer.
English: After refinement of PECsw using the FOCUS model as recommended by CVMP guideline CVMP/ERA/418282/2005, the RQ remains above 1 for Daphnia.
Danish: Efter forbedret bestemmelse af PECsw ved hjælp af FOCUS-modellen som anbefalet i CVMP's retningslinjer CVMP/ERA/418282/2005 er risikoforholdet fortsat over 1 for dafnier.
English: The referral for Prontax 5 mg/ml pour on solution for cattle relates to the potential serious risks raised by France and the Netherlands regarding the environmental risk assessment (ERA).
Danish: Henvisningen for Prontax, pour-on opløsning, 5 mg/ml, til kvæg, vedrører de potentielle alvorlige risici, der blev påpeget af Frankrig og Nederlandene vedrørende miljørisikovurderingen (ERA).
English: Two Concerned Member States (the Netherlands and France) considered that the authorisation of Dectomax 5 mg/ml pour-on solution for cattle may present a potential serious risk to the environment.
Danish: To at de berørte medlemsstater (Nederlandene og Frankrig) fandt, at godkendelsen af Dectomax, pour-on opløsning, 5 mg/ml, til kvæg, kan udgøre en potentiel alvorlig risiko for miljøet.
English: The CVMP was asked to give its opinion on the concerns raised by the Concerned Member States and to conclude on the benefit/risk balance for Prontax 5 mg/ml pour-on solution for cattle.
Danish: CVMP blev anmodet om at fremsætte en udtalelse om de betænkeligheder, der var rejst af de berørte medlemsstater, og om benefit/risk-forholdet for Prontax, pour-on opløsning, 5 mg/ml, til kvæg.
English: The concentration of total doramectin residues excreted in cattle faeces peaked at 21 days after administration (270 µg/kg) and declined thereafter, accounting for 52 µg/kg at 35 days and 3.9 µg/kg at 56 days.
Danish: Den totale restkoncentration af doramectin, der blev udskilt i fæces fra kvæg, var maksimal på dag 21 efter administrationen (270 µg/kg) og aftog derefter til 52 µg/kg på dag 35 og 3,9 µg/kg på dag 56.
English: The product has dual action against endo- and ecto-parasites and may reduce the number of treatments with different pharmaceutical products.
Danish: Produktet virker mod både endo- og ektoparasitter og kan for en række andre produkter mindske det nødvendige antal behandlinger.
English: The risk to aquatic ecosystems and dung fauna can be reduced by avoiding too frequent and repeated use of doramectin (and products of the same anthelmintic class) in cattle.
Danish: Risikoen for vandøkosystemer og organismer i gødning kan mindskes ved at undgå for hyppig og gentagen brug af doramectin (og produkter i samme klasse af anthelmintika) hos kvæg.
English: The following text should be included in section 5.3 of the SPC (environmental properties): Like other macrocyclic lactones, doramectin has the potential to adversely affect non-target organisms.
Danish: Følgende tekst skal indsættes i punkt 5.3 af produktresuméet (Miljøoplysninger): Ligesom andre makrocykliske lactoner har doramectin potentiale for negativ påvirkning af andre organismer end målorganismerne.
English: The applicant Pfizer Limited has submitted an application for a decentralised procedure for Dectomax 5 mg/ml pour-on solution for cattle.
Danish: Ansøgeren, Pfizer Limited, har indgivet en ansøgning ved den decentrale procedure for Dectomax, pour-on opløsning, 5 mg/ml, til kvæg.
English: The product is applied topically along the mid-line of the back in a narrow strip between the withers and tailhead.
Danish: Produktet påføres topisk i en smal stribe langs ryggens midterlinje fra skulderbladene til haleroden.
English: Overall summary of the scientific evaluation of Prontax 5 mg/ml pour-on solution for cattle and associated names
Danish: Samlet resumé af den videnskabelige vurdering af Prontax, pour-on opløsning, 5 mg/ml, til kvæg, og relaterede navne
English: The product is indicated for treatment of gastrointestinal roundworms, lungworms, eyeworms, warbles, sucking and biting lice, mange mites and hornfly in cattle.
Danish: Produktet er indiceret til behandling af gastrointestinale rundorm, lungeorm, øjenorm, bremselarver, sugende og bidende lus, skabmider og stikfluer hos kvæg.
English: Dectomax 5 mg/ml pour-on solution for cattle was transferred from Pfizer Healthcare Ireland to
Danish: Dectomax, pour-on opløsning, 5 mg/ml, til kvæg, overgået fra Pfizer Healthcare Ireland til
English: Doramectin is an antipatasitic agent, isolated from the fermentation of selected strains derived from the soil organism Streptomyces avermitilis.
Danish: Doramectin er et antiparasitikum, der udvindes ved fermentering af udvalgte stammer af den jordlevende organisme Streptomyces avermitilis.
English: As no harmonised guidance on how to conduct Tier B assessment studies for dung insects is currently available, risk mitigation measures to reduce exposure are considered to overcome the identified risk.
Danish: Da der på nuværende tidspunkt ikke foreligger en harmoniseret vejledning for undersøgelser med henblik på niveau B-vurdering for insekter i gødning, vurderedes det, at den påpegede risiko bør imødegås med foranstaltninger, som mindsker eksponeringen.
English: • On the basis of environmental risk assessment data submitted with the application it was considered that in order to address the identified risks for aquatic organisms and dung fauna as well as any remaining uncertainty regarding bioaccumulation risk mitigation measures should be applied; the CVMP concluded that the objections raised by the Netherlands and France should not prevent the granting of a marketing authorisation for Prontax 5 mg/ml pour-on solution for cattle and associated names (see annex I) as the overall benefit-risk balance for the product is positive subject to the recommended changes in the product information set out in annex III.
Danish: • På grundlag af den miljørisikovurdering, der er forelagt sammen med ansøgningen, blev det anset for nødvendigt at indføre foranstaltninger til imødegåelse af de påpegede risici for vandorganismer og organismer i gødning og af eventuel tilbageværende usikkerhed om bioakkumuleringkonkluderede CVMP, at de indvendinger, der er rejst af Nederlandene og Frankrig, ikke bør være til hinder for udstedelse af markedsføringstilladelse for Prontax, pour-on opløsning, 5 mg/ml, til kvæg, og relaterede navne (se bilag I), da det overordnede benefit/risk-forhold for produktet er positivt, forudsat at der foretages de anbefalede ændringer i produktinformationen, som fremgår af bilag III.
English: Withdrawal periods
Danish: Tilbageholdelsestid
English: Prontax 5 mg/ml pour-on solution for cattle contains doramectin as active ingredient.
Danish: Prontax, pour-on opløsning, 5 mg/ml, til kvæg, indeholder doramectin som det aktive indholdsstof.
English: The risk characterisation for dung fauna was performed using Predicted Environmental Concentrations (PECs) for dung, which were derived using the metabolism study provided.
Danish: Der blev foretaget risikokarakterisering for organismer i gødning ved hjælp af forventede eksponeringskoncentrationer (PEC-værdier) for gødning, der var udledt af den forelagte metaboliseringsundersøgelse.
English: Prontax 5 mg/ml pour-on solution for cattle and associated names is a clear, colourless pour-on solution containing doramectin.
Danish: Prontax, pour-on opløsning, 5 mg/ml, til kvæg, og relaterede navne er en klar, farveløs pour-on opløsning, der indeholder doramectin.
English: The current data package does not allow the assessment of bioaccumulation and therefore, bioaccumulation of doramectin cannot be ruled out.
Danish: Den nuværende dokumentationspakke giver ikke mulighed for vurdering af bioakkumulering, hvorfor bioakkumulering af doramectin ikke kan udelukkes.
English: The reference product for this generic application was Dectomax 5 mg/ml pour-on solution for cattle.
Danish: Referenceproduktet for denne generiske ansøgning var Dectomax, pour-on opløsning, 5 mg/ml, til kvæg.
English: Elanco Animal Health, Eli Lilly and Company Limited and the name of the reference product in
Danish: Elanco Animal Health, Eli Lilly and Company Limited, og navnet på referenceproduktet i Irland er ændret til Zearl, pour-on opløsning, 5 mg/ml, til kvæg.
English: The potential serious risks regarding the environment identified by France and the Netherlands are risks to dung fauna and Daphnia in accordance with the proposed instructions for use and a risk identified by the Netherlands due to the bioaccumulation potential linked to the determination of the log KOW by using a test method, which was not considered appropriate for the active ingredient.
Danish: De potentielle alvorlige risici for miljøet, der blev påpeget af Frankrig og Nederlandene, er dels risici for organismer i gødning og for dafnier i henhold til den påtænkte brugsanvisning, dels en af Nederlandene påpeget risiko betinget af potentialet for bioakkumulering som følge af, at log KOW blev bestemt ved en metode, der anses for uegnet til det aktive indholdsstof.
English: The benefit-risk evaluation is deemed to be positive provided that the recommended risk mitigation measures are added to the product literature regarding risk to aquatic organisms and dung fauna.
Danish: Konklusioner vedrørende benefit/risk-forholdet Benefit/risk-vurderingen anses for at være positiv, forudsat at der i produktoplysningerne tilføjes de anbefalede foranstaltninger til nedsættelse af risikoen over for vandorganismer og organismer i gødning.
English: Faeces containing doramectin excreted onto pasture by treated animals may reduce the abundance of dung feeding organisms which may impact on the dung degradation.
Danish: Fæces indeholdende doramectin, som af de behandlede dyr udskilles på græsarealer, kan nedsætte mængden af organismer i gødning, så gødningens nedbrydning påvirkes.
English: Based on Predicted Environmental Concentrations (PEC) for surface water PECsw of 0.0026 µg doramectin/l surface water (run-off scenario) and PECsw of 0.5225 µg doramectin/l surface water (direct excretion) an acute risk for Daphnia was identified in Tier A for both exposure scenarios with PEC/PNEC risk quotients (RQ) of 26 and 5225, respectively.
Danish: De forventede eksponeringskoncentrationer (PEC-værdier) for overfladevand, PECsw var 0,0026 µg doramectin/l overfladevand (spildscenariet) og 0,5225 µg doramectin/l overfladevand (scenariet direkte udskillelse).
English: As the risk for Daphnia could not be ruled out by PEC refinements Tier B assessment should be performed according VICH Guideline 38 be performed for which a Daphnia magna reproduction study is required.
Danish: Da forbedrede PEC-bestemmelser ikke kunne udelukke risiko over for dafnier, skal der foretages niveau B-vurdering i henhold til VICH-Guideline 38.
English: The outcome of the ERA indicates that RQ are higher than 1 in the Tier A assessment in two cases, namely daphnids (following direct excretion scenario) and dung fauna.
Danish: Miljørisikovurderingen viser et risikoforhold > 1 i niveau A-bestemmelsen i to tilfælde, nemlig for dafnier (ved scenariet med direkte udskillelse) og for organismer i gødning.
English: In terms of environmental safety, in addition to the fact that the current data package does not allow to rule out bioaccumulation of doramectin, a risk to the aquatic compartment has been identified based on available toxicity data (acute toxicity for Daphnia magna) as well as a risk to dung fauna exposed to residue-containing dung out when the product is used in accordance with the recommended posology.
Danish: Derudover er der påpeget risiko for det akvatiske delmiljø på grundlag af de foreliggende toksicitetsdata (akut toksicitet over for Daphnia magna) samt risiko over for gødningsorganismer ved eksponering for restkoncentrationer i gødning, når produktet anvendes i den anbefalede dosering.
English: In order to address the identified risks for aquatic organisms and dung fauna as well as any remaining uncertainty regarding bioaccumulation the following risk mitigation measures are recommended: The following text is proposed in section 4.5 of the SPC(special precautions for use): Doramectin is very toxic to dung fauna and aquatic organisms and may accumulate in sediments.
Danish: Følgende foranstaltninger anbefales for at imødegå de påpegede risici for vandorganismer og organismer i gødning og eventuel tilbageværende usikkerhed om bioakkumulering: Følgende tekst foreslås indsat i punkt 4.5 af produktresuméet (Særlige advarsler og forsigtighedsregler vedrørende brugen):
English: Denmark Pfizer Limited Veterinary Medical Research &
Danish: Pfizer Limited Veterinary Medical
English: INN/Strength Animal species
Danish: Navn Lægemiddelform INN/Styrker Dyrearter Indgivelsesvej Anbefalet dosis
English: A Phase II, Tier A assessment was required.
Danish: Der krævedes en fase IIvurdering, niveau A.
English: Conclusions on the benefit-risk balance
Danish: Vurdering af benefit/risk-forholdet
English: Further PEC refinement considering that peak excretion of total residues occurred on day 21 after administration and accounted for 2.3% of the administered dose, as well as based on sediment partitioning lead to a PECsw-refined-direct of 0.00037 µg/l, resulting in a RQ for Daphnia (3.7) still higher than 1.
Danish: Der blev foretaget en yderligere forbedret bestemmelse af PEC-værdien, hvor der blev taget hensyn til, at den maksimale udskillelse af samlede restmængder optrådte på dag 21 efter administrationen og udgjorde 2,3 % af den administrerede dosis, og desuden blev beregningen baseret på sedimentfordeling.
English: Based on the Predicted No Effect Concentrations (PNECs) derived from the LC50 of 1.34 µg/kg soil for horn flies (Haematobia irritans) and the NOEC of 4.0 µg/kg soil for dung beetles (Ontophagus gazelle) the resulting risk quotients for both species were high (20149 and 675, respectively, based on the amount of total residues in dung at day 21 after administration), indicating a high acute risk to dung insects in Tier A. Consequently a Tier B assessment should be performed.
Danish: Det resulterende risikoforhold for begge arter var højt (hhv. 20 149 og 675 på grundlag af de totale restkoncentrationer i gødning på dag 21 efter administrationen).
English: Pharmaceutical form
Danish: Medical
English: 5 mg/ml pour-on solution for cattle to Prontax 5 mg/ml pour-on solution for cattle1.
Danish: • Under den decentrale procedure blev det påtænkte særnavn ændret fra Dectomax, pour-on opløsning, 5 mg/ml, til kvæg, til Prontax, pour-on opløsning, 5 mg/ml, til kvæg1.
English: It is very important that you use Temybric Ellipta every day, as instructed by your doctor.
Danish: Det er meget vigtigt, at du bruger Temybric Ellipta hver dag i henhold til lægens anvisninger.
English: Your doctor may wish to monitor you carefully if you are taking any of these medicines as they may increase the side effects of Temybric Ellipta.
Danish: Lægen vil muligvis overvåge dig omhyggeligt, hvis du tager nogen af disse lægemidler, da de kan øge bivirkningerne fra Temybric Ellipta.
English: Administration of Temybric Ellipta to pregnant women should only be considered if the expected benefit to the mother justifies the potential risk to the foetus.
Danish: Administration af Temybric Ellipta til gravide kvinder bør kun overvejes, hvis den forventede fordel for moderen opvejer enhver mulig risiko for fostret.
English: There is no relevant use of Temybric Ellipta in the paediatric population (under 18 years of age) for the indication of COPD.
Danish: Det er ikke relevant at anvende Temybric Ellipta hos den pædiatriske population (under 18 år) til indikationen KOL.
English: Patients should be informed about the signs and symptoms of acute narrow-angle glaucoma and should be informed to stop using Temybric Ellipta and to contact their doctor immediately should any of these signs or symptoms develop.
Danish: Patienterne skal informeres om tegn og symptomer på akut snævervinklet glaukom og om, at de skal stoppe med at bruge Temybric Ellipta og omgående kontakte deres læge, hvis nogen af disse tegn eller symptomer opstår.
English: Temybric Ellipta should not be used in patients with asthma since it has not been studied in this patient population.
Danish: Temybric Ellipta må ikke bruges til patienter med astma, fordi det ikke er blevet undersøgt hos denne patientpopulation.
English: There are no clinical data to support the use of Temybric Ellipta for the treatment of acute episodes of bronchospasm, or to treat an acute COPD exacerbation (i.e. as a rescue therapy).
Danish: Der er ingen kliniske data, der understøtter brugen af Temybric Ellipta til behandling af akutte tilfælde af bronkospasme eller akut eksacerbation af KOL (dvs. som nødbehandling).