natgillin/translations-raw huggingface dataset:
Under indbringelsesproceduren for Gutal drøftede man som en eventuel risikoreducerende foranstaltning muligheden af at undlade at sprede gødning på det samme jordområde flere år i træk for at bremse zinkakkumuleringen.
During the aforementioned referral procedure for Gutal, the possibility of not spreading of manure on the same area of land in successive years in order to slow down the accumulation of zinc was considered as a possible risk mitigation measure.
Zinkoxid Colistinsulf at
Zinc oxide Colistin sulfate
Sulfaguanidin og zinkoxid i kombination
Sulfaguanidine and zinc oxide combination
• I de fremlagte undersøgelser har man dokumenteret effektiviteten af foder med et højt indhold af zinkoxid hos fravænnede smågrise i alderen 3-4 uger under særlige avlsforhold (intensiv avl,
• Based on the studies provided, the efficacy of high content of zinc oxide in feed was shown in weaned piglets aged 3-4 weeks old in particular breeding conditions (intensive breeding, housing in building, grouping in pens with piglets of different litters/origins, premature separation with the sow, abrupt feeding transition from milk to cereal based feed).
INN Styrke
Strength
Zinkoxid Sulfaguani din
Zinc oxide Sulfaguanidin um
• CVMP mener, at virkningen af zinkoxid-holdige veterinærlægemidler til behandling af diarré hos smågrise efter fravænning ikke kan påvises ud fra de tilgængelige data.
• the CVMP considered that the efficacy of veterinary medicinal products containing zinc oxide for treatment of post-weaning diarrhoea in piglets is not supported by data and cannot be demonstrated;
Hvad angår potentialet for risikoreduktion ved opfyldelse af lokale eller nationale regler om, at gødning skal spredes i en minimumsafstand fra åbent vand, mener CVMP, at dette kun vil begrænse direkte spredning til vandløb og ikke vil have nogen indvirkning på, hvor meget zink der når frem til vandoverflader ved udvasknings- og afstrømningsprocesser.
Regarding the potential for risk reduction when complying with local or national rules for the minimum distance from open water at which manure should be spread, the CVMP considered that this would only be applicable to limit direct entry to water courses, but would not affect the zinc reaching water surface by leaching and run-off processes.
E. coli (Bednortz C. et al., 2013)26 kan zinktilskud også have direkte indvirkning på bakteriers antibiotikaresistensprofil via andre mekanismer.
Zinc supplementation may also directly influence the antimicrobial resistance profiles of bacteria via other mechanisms based on work in E. coli (Bednortz C. et al., 2013)26.
Da der ikke foreligger relevante data, understøttes indikationen "behandling af diarré hos fravænnede smågrise" ikke.
Treatment of post-weaning diarrhoea in piglets In the absence of data the indication ‘treatment of post-weaning diarrhoea in piglets' is not supported.
I betragtning af den anseelige mængde zinkoxid, der er i de omhandlede produkter (Enteroxid N AMV aniMedica og aniMedica Enteroxid N), er det desuden ikke relevant at klassificere stoffet som et hjælpestof eller et aktivt stof.
The CVMP confirmed that, at this level, zinc oxide cannot be considered as an excipient only and that furthermore, considering the substantial amount of zinc oxide present in the aforementioned products (Enteroxid N AMV aniMedica and aniMedica Enteroxid N), the classification of the substance as an excipient or active substance is not relevant.
14 Arche Consulting Soil PNEC calculator - link 15 ECHA, 2014.
13 Metal bioavailability assessment tool (M-BAT) - link 14 Arche Consulting Soil PNEC calculator - link making a correction on the exposure assessment for bioavailability of metals in sediment systems (ECHA 2014)15.
CVMP vurderer således, at de tidligere anbefalede risikoreducerende foranstaltninger i forbindelse med indbringelsesproceduren for Gutal (EMEA/V/A/108), jf. artikel 33, stk. 4, i direktiv 2001/82/EF, kun vil forsinke de risici, der er identificeret for alle delmiljøerne, hvis man gødsker jord med gødning fra svin, der er behandlet med zinkoxid-holdige veterinærlægemidler.
33(4) of Directive 2001/82 for Gutal (EMEA/V/A/108), will only delay the risks identified in all environmental compartments if manure from pigs treated with veterinary medicinal products containing zinc oxide is applied to land.
Hvad angår den risikoreducerende foranstaltning til opfyldelse af lokale eller nationale regler om, at gødning skal spredes i en minimumsafstand fra åbent vand, mener CVMP, at den kun vil kunne anvendes til forebyggelse af direkte spredning til vandløb og ikke vil have nogen indvirkning på, hvor meget zink der når frem til overfladevand og drikkevand ved udvasknings- og afstrømningsprocesser.
Regarding the risk mitigation measure for compliance with local or national rules for the minimum distance from open water at which manure should be spread, the CVMP considered that this would only be applicable to prevent direct entry to water courses, but would not affect the zinc reaching water surface and drinking water through leaching and run-off processes.
Da datasøgningen i forbindelse med EU's risikovurderingsrapport (2010) var gennemført, blev flere data imidlertid tilgængelige, og de blev anvendt af nogle af markedsføringstilladelsesindehaverne til fastsættelse (finjustering) af PNEC-værdierne for de pågældende delmiljøer.
However, since the data search for the EU RAR (2010) was completed, more data have become available and were used by some of the
Ved brug af "korrektion for biotilgængelighed"-tilgangen og under hensyn til, at biotilgængeligheden afhænger af jordtype og tidspunktet for, hvornår zinken er blevet indlejret i jorden (zinkældning), var den biotilgængelige del for både sand- og lerjord til gengæld under PNECsoil på 26 mg/kg (16,3 og 14,4 mg/kg for henholdsvis sandjord og lerjord).
On the other hand, using the bioavailability correction approach, and considering within this approach that bioavailability is dependent on soil type and the time zinc was incorporated onto soil (i.e., zinc aging), the bioavailable fraction was for both
• CVMP mener, at den overordnede benefit/risk-balance for veterinærlægemidler, der indeholder zinkoxid og administreres oralt til fødevareproducerende arter, er negativ, da fordelene ved zinkoxid til forebyggelse af diarré hos svin ikke opvejer risikoen for miljøet.
• the CVMP considered that the overall benefit-risk balance for the for veterinary medicinal products containing zinc oxide to be administered orally to food producing species is negative, as the benefits of zinc oxide for the prevention of diarrhoea in pigs do not outweigh the risks for the environment; the CVMP has recommended the refusal of the granting of the marketing authorisations and the withdrawal of the existing marketing authorisations for veterinary medicinal products containing zinc oxide to be administered orally to food producing species as referred in Annex I.
12 European Union Risk Assessment Report (EU RAR) on zinc (2010) - link 13 Metal bioavailability assessment tool (M-BAT) - link hjælp af et Excel-værktøj til beregning af PNEC-værdien i jord (udviklet af Arche Consulting)14, som anvender relevante parametre til bestemmelse af zinks biotilgængelighed i jord, herunder pH, organisk indhold, lerindhold og kationbytningskapacitet.
The calculation of site-specific PNECs for Gutal was carried out using an Excel tool soil PNEC calculator (developed by Arche Consulting)14 which incorporates parameters relevant to determine soil zinc bioavailability, such as pH, organic and clay content, and the cation exchanged capacity.
Lægemiddelform Dyrearter Administrations vej
Pharmaceutical form
Det samme gælder måden, hvorpå måldyrene holdes og gødningen håndteres, samt de foreslåede risikoreducerende foranstaltninger (fortynding af gødningen og afstand til overfladevand), selv om disse er i overensstemmelse med CVMP/VICH-retningslinjerne (CVMP/VICH/790/03) og blev anbefalet ved indbringelsesproceduren for Gutal (EMEA/V/A/108), jf. artikel 33, stk. 4, i direktiv 2001/82, til at reducere akkumuleringen af zink i de enkelte delmiljøer.
Considering the use of these products, current EU rules and Good Agricultural Practice on manure spreading, how the target animals are kept and how manure is managed, the suggested risk mitigation measures (dilution of manure and distance to surface waters), although they are in line with the CVMP/VICH guideline (CVMP/VICH/790/03) and were recommended for the referral procedure under Article 33(4) of Directive 2001/82 for Gutal (EMEA/V/A/108), in order to reduce the accumulation of zinc in each compartment, cannot guarantee that they can effectively eliminate either the imminent and future environmental risks identified from the risk assessment, but will just delay the total zinc accumulation in the environment (i.e. the time when the PEC will exceed the PNECs).
Chapter R.7b:Endpoint specific guidance
Chapter R.7b:Endpoint specific guidance 16 VICH GL6: Guideline on Environmental Impact Assessment (EIAS) for Veterinary Medicinal Products - Phase I
• CVMP mener, at virkningen af zinkoxidholdige veterinærlægemidler til forebyggelse af diarré hos smågrise efter fravænning er påvist ud fra de tilgængelige data.
• the CVMP considered that based on the available data the efficacy of veterinary medicinal products containing zinc oxide for prevention of post-weaning diarrhoea in piglets is demonstrated;
• CVMP mener, at det ud fra de tilgængelige data kan fastslås, at der foreligger risici for miljøet i alle scenarier på grund af akkumuleringen af zink, enten straks (sedimenter, visse typer jord og overfladevand) eller forsinket (andre typer jord, grundvand og overfladevand).
• the CVMP considered that based on the available data risks to the environment have been identified, due to accumulation of zinc, for all scenarios, either immediately (sediment, some soil and surface water types) or delayed (other soil types, ground-, and surface waters); the CVMP acknowledged that all predictive models have an inherent degree of uncertainty in their parameterisation, and the results generated (i.e., time estimates) are based on a limited amount of input data which is likely to influence the model output;
Det enkelte aktive stof i et
Zinc oxide as a sole active substance
Sintofarm S.p.A, Tekro, spol.
Slovak Republic Tekro, spol.
En lang række publicerede undersøgelser har vist en stærk korrelation mellem høje doser af zinktilskud i næringsmidler og den øgede prævalens af antibiotikaresistente bakterier (ved in vivo-test eller ved analyse af miljøisolater).
Several published studies demonstrated (during in vivo experiments or by investigating environmental isolates) a strong correlation between high doses of zinc supplementation in food and an increase in the prevalence of antimicrobial resistant bacteria.
Det samme gælder måden, hvorpå måldyrene holdes og gødningen håndteres, samt de ovenfor foreslåede risikoreducerende foranstaltninger, selv om disse er i overensstemmelse med CVMP/VICHretningslinjerne (CVMP/VICH/790/03) og blev foreslået ved indbringelsesproceduren for Gutal (EMEA/V/A/108), jf. artikel 33, stk. 4, i direktiv 2001/82/EF, til at reducere akkumuleringen af zink i de enkelte delmiljøer.
Considering the use of these products, current EU rules and Good Agricultural Practice (GAP) on manure spreading, how the target animals are kept and how manure is managed, the risk mitigation measures proposed above, although they are in line with the CVMP/VICH guideline (CVMP/VICH/790/03) and were proposed for the referral procedure on Gutal under Article 33(4) of Directive 2001/82/EC (EMEA/V/A/108) in order to reduce the accumulation of zinc in each compartment, cannot guarantee that they can effectively eliminate imminent and future environmental risks identified in the risk assessment, but will just delay the total zinc accumulation in the environment, (i.e. the time when PEC will exceed PNECs).
Zinkoxid 492 mg/g Premix
Zinc oxide 492 mg/g
En lang række publicerede undersøgelser har vist en korrelation mellem høje doser af zinktilskud i næringsmidler og prævalensen af antibiotikaresistens (ved in vivo-test eller ved analyse af miljøisolater).
Several published studies demonstrated (during in vivo experiments or by investigating environmental isolates) a correlation between high doses of zinc supplementation in food and the prevalence of antimicrobial resistance.
Zinkoxid 622 mg/g Premix
Zinc oxide 622 mg/g
Zinkoxid 600 mg/g Premix
Zinc oxide 600 mg/g
Vær forsigtig med, hvor meget alkohol du indtager.
• Be careful how much alcohol you drink.
Børn og unge (10 til 17 år)
Children and adolescents (10 to 17 years of age)
- du har haft et slagtilfælde, specielt hvis du er ældre.
You have had a stroke, especially if you are elderly.
(17) Kan medføre fald.
(17) May lead to falls.
Visse lægemidler mod HIV.
Some medicines for HIV.
Patienterne i disse forsøg døde af en række forskellige årsager, som var i henhold til det forventede i denne population.
The patients in these trials died from a variety of causes that were consistent with expectations for this population.
(5) Forværring af eksisterende diabetes er rapporteret i meget sjældne tilfælde.
(5) Exacerbation of pre-existing diabetes has been reported in very rare cases.
Tæt overvågning og monitorering bør fortsætte, indtil patienten kommer sig.
Close medical supervision and monitoring should be continued until the patient recovers.
- du har lavt blodtryk.
You have low blood pressure.
W1K 1LN, Storbritannien
W1K 1LN, UK
- du ved, at du tidligere har haft et lavt antal hvide blodlegemer (som måske eller måske ikke har været forårsaget af andre lægemidler).
You know that you have had low levels of white blood cells in the past (which may or may not have been caused by other medicines).
• En langvarig og smertefuld erektion (priapismus).
• A long-lasting and painful erection (priapism).
Der er dog også rapporteret overlevelse ved akut overdosering med op til 30 gram.
However, survival has also been reported following acute overdoses of up to 30 grams.
Det kan være en hjælp at fortælle en slægtning eller en god ven, at du er deprimeret og bede dem læse denne information.
You may find it helpful to tell a relative or close friend that you are depressed, and ask them to read this leaflet.
Det blev dog bemærket, at understøttende indirekte evidens indikerer, at der kan forventes en virkning efter nuværende eller tidligere fiasko (utilstrækkelig respons eller intolerans) med et eller to antidepressive midler.
It was nevertheless noted that supportive indirect evidence indicates that an effect can be expected after current or earlier failure (insufficient response or intolerance) with one or two antidepressants.
- Synk tabletterne hele med et glas vand.
• Swallow your tablets whole with a drink of water.
- Du skal tage tabletten én gang dagligt.
• You will take your tablets once a day.
- du har problemer med leveren.
You have problems with your liver.
- Udvalget tog alle de tilgængelige data i betragtning, der var fremsendt om quetiapins sikkerhed og virkning,
- The Committee considered all the available data submitted on the safety and efficacy of quetiapine.
Tardiv dyskinesi:
Tardive Dyskinesia:
En opdateret udgave af risikostyringsplanen skal fremsendes senest den 30. september 2010 i tråd med den årlige fremsendelse af den periodiske sikkerhedsopdateringsrapport for Seroquel XR og skal afspejle ovenstående betingelser.
An updated version of the Risk Management Plan should be submitted by 30th September 2010 in line with the annual submission of the Period Safety Update Report for Seroquel XR and reflecting the above conditions.
- du eller nogen i din familie har haft blodpropper, da denne type medicin har været forbundet med dannelsen af blodpropper.
You or someone else in your family has a history of blood clots, as medicines like these have been associated with formation of blood clots.
Den potentielle gavnlige virkning som tillægsbehandling blev således taget i betragtning.
Thus the potential benefit as add-on treatment was considered.
Dette kræver omgående medicinsk behandling.
Immediate medical treatment may be needed.
Bemærk: Hyppigheden svarer til den, der er set hos voksne, men irritabilitet kan være forbundet med andre kliniske konsekvenser hos børn og unge sammenlignet med voksne.
Note: The frequency is consistent to that observed in adults, but irritability might be associated with different clinical implications in children and adolescents as compared to adults.
Sikkerheden og effekten af quetiapin under graviditet er endnu ikke fastlagt.
The safety and efficacy of quetiapine during human pregnancy have not yet been established.
Irritabilitet4
Irritability4
I begge forsøg blev patienter med kendt manglende respons på Seroquel ekskluderet.
In both studies, patients with known lack of response to Seroquel were excluded.
¾ Svensk record linkage-undersøgelse (SE-RLS) i henhold til en godkendt protokol.
¾Swedish Record Linkage Study (SE-RLS) in accordance with an agreed protocol.
• Det aktive stof er quetiapin.
• The active substance is quetiapine.
Desuden har norquetiapin høj affinitet for noradrenalintransporteren (NET).
Additionally, norequetiapine has high affinity for the norepinephrine transporter (NET).
Børn og unge:
Children and Adolescents:
Distribution: Quetiapin er ca. 83 % bundet til plasmaproteiner.
Distribution: Quetiapine is approximately 83% bound to plasma proteins.
Vedligeholdelsesdosis (daglig dosis) vil afhænge af din sygdom og dit behov, men vil normalt være mellem 150 mg og 800 mg.
The maintenance dose (daily dose) will depend on your illness and needs but will usually be between 150 mg and 800 mg.
Et andet forsøg viste ikke en additiv effekt ved uge 6.
A second study did not demonstrate an additive effect at week 6.
Ændringer i thyroidea funktionstest er også blevet observeret hos børn og unge.
Changes in thyroid function tests have also been observed in children and adolescents.
Angioødem6, Stevens-Johnson syndrom6
Angioedema6, Stevens-Johnson syndrome6
Endvidere er langsigtede sikkerhedskonsekvenser af behandlingen med Seroquel på vækst og modning ikke blevet undersøgt ud over 26 uger.
Furthermore, the long-term safety implications of treatment with Seroquel on growth and maturation have not been studied beyond 26 weeks.
QT-forlængelse:
QT Prolongation:
(2) Somnolens kan forkomme - oftest i de første 2 uger af behandlingen og ophører normalt ved fortsat administration af quetiapin.
(2) Somnolence may occur, usually during the first two weeks of treatment and generally resolves with the continued administration of quetiapine.
Mindre fald i total T3 og reverse T3 sås kun ved højere doser.
Smaller decreases in total T3 and reverse T3 were seen only at higher doses.
Thioridazin (et andet antipsykotika).
Thioridazine (another anti-psychotic medicine).
Der er ikke udført formelle interaktionsforsøg med almindeligt anvendte kardiovaskulære lægemidler.
Formal interaction studies with commonly used cardiovascular medicinal products have not been performed.
Epilepsi lægemidler (f.eks. phenytoin eller carbamazepin).
Epilepsy medicines (like phenytoin or carbamazepine).
¾ Udførelse af ny undersøgelse af lægemiddelanvendelse i flere EU-lande (EU DUS) i henhold til en godkendt protokol.
¾Perform new EU Multi-Country Drug Utilisation Study (EU DUS) in accordance with an agreed protocol.
Børn og unge De samme bivirkninger, der indtræder hos voksne, kan også forekomme hos børn og unge.
Children and adolescents The same side effects that may occur in adults may also occur in children and adolescents.
SAMLET RESUMÉ AF DEN FAGLIGE VURDERING AF SEROQUEL XR OG TILKNYTTEDE NAVNE (se bilag I)
OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF SEROQUEL XR AND ASSOCIATED NAMES (see Annex I)
• Forværring af eksisterende sukkersyge.
• Worsening of pre-existing diabetes.
De fleste alvorlige neutropenitilfælde er sket inden for et par måneder efter quetiapin behandlingen er startet.
Most cases of severe neutropenia have occurred within a couple of months of starting therapy with quetiapine.
Seroqul Prolong bør derfor kun anvendes under graviditet, hvis fordelene berettiger de potentielle risici.
Therefore, Seroquel XR should only be used during pregnancy if the benefits justify the potential risks.
Reduktionen i total og fri T4 var højest indenfor de første 2 - 4 uger af Seroquelbehandlingen, uden yderligere reduktion ved længerevarende behandling.
The reduction in total and free T4 was maximal within the first two to four weeks of Seroquel treatment, with no further reduction during long-term treatment.
Dette skyldes, at den samlede virkning af Seroquel Prolong og alkohol kan gøre dig søvnig.
This is because the combined effect of Seroquel XR and alcohol can make you sleepy.
Der er ingen aktivt kontrollerede langsigtede sikkerhedsdata for MDD, og de placebokontrollerede randomiserede tilbagetrækningsdata er af begrænset værdi, fordi antallet af patienter bliver lavere med tiden.
There are no active controlled on long-term safety data in MDD and the placebo controlled randomised withdrawal data are of limited value due to decreased numbers of patients over time.
Depression lidelse er forbundet med en øget risiko for selvmordstanker, selvdestruktiv adfærd og selvmord (selvmordsrelaterede hændelser).
Depression is associated with an increased risk of suicidal thoughts, self-harm and suicide (suiciderelated events).
Alvorlig neutropeni:
Severe Neutropenia:
Desuden bør læger overveje den potentielle risiko for selvmordsrelaterede hændelser efter pludseligt ophør af behandling med quetipin, som følge af de kendte risikofaktorer for den behandlede sygdom.
In addition, physicians should consider the potential risk of suicide-related events after abrupt cessation of quetiapine treatment, due to the known risk factors for the disease being treated.
Passende klinisk monitorering i overensstemmelse med de gældende retningslinjer for antispykotisk behandling anbefales.
Appropriate clinical monitoring is advisable in accordance with utilised antipsychotic guidelines.
Forekommer hovedsagelig i de første uger af behandlingen.
This is most likely to occur within the first few weeks of treatment.
BILAG II FAGLIGE KONKLUSIONER OG BEGRUNDELSER FOR ÆNDRING AF PRODUKTRESUMÉ OG INDLÆGSSEDDEL FREMLAGT AF EMEA
ANNEX II SCIENTIFIC CONCLUSIONS AND GROUNDS FOR AMENDMENT OF THE SUMMARY OF PRODUCT CHARACTERISTICS AND PACKAGE LEAFLET PRESENTED BY THE EMEA
Det kan være ændringer i mængden af visse fedttyper (triglycerider og totalkolesterol) eller sukker i blodet, fald i mængden af visse typer blodlegemer og stigninger i mængden af hormonet prolaktin i blodet.
These include changes in the amount of certain fats (triglycerides and total cholesterol) or sugar in the blood, decreases in the number of certain types of blood cells and increases in the amount of the hormone prolactin in the blood.
Selvom hæmning af absorption ved overdosis ikke er undersøgt, kan maveskylning være indiceret ved svære forgiftninger og hvis det er muligt at udføre inden for en time efter indtagelse.
Whilst the prevention of absorption in overdose has not been investigated, gastric lavage can be indicated in severe poisonings and if possible to perform within one hour of ingestion.
erythromycin eller clarithromycin (mod infektioner).
Erythromycin or clarithromycin (for infections).
Hvis dette er tilfældet, kan det være at din læge checker dit blodsukkerniveau, mens du tager Seroquel Prolong.
If you do, your doctor may check your blood sugar levels while you are taking Seroquel XR.
Yderligere information:
Additional information:
Et langsommere doseringsregime kan overvejes til patienter med underliggende kardiovaskulær sygdom.
A slower titration regimen could be considered in patients with underlying cardiovascular disease.