natgillin/translations-raw huggingface dataset:
Efter at have gennemgået samtlige skriftligt fremlagte data konkluderede CVMP, at miljørisikovurderingen for Norbonex, pour-on, opløsning, 5 mg/ml, til kødkvæg og malkekvæg viser, at produktet ikke forventes at udgøre en risiko for miljøet, når det anvendes som anbefalet i produktinformationen, der indeholder de anbefalede risikobegrænsende foranstaltninger.
Having considered all the overall submitted data in writing the CVMP concluded that the ERA for Norbonex 5 mg/ml Pour-On Solution for Beef and Dairy Cattle shows that the product is not expected to pose a risk for the environment when used as recommended in the SPC which includes following the recommended RMM.
For at afbøde risikoen over for gødningsinsekter blev der derfor indsat risikobegrænsende foranstaltninger i produktoplysningerne.
Consequently in order to mitigate the risk for dung insects RMM were included in the product information.
Der blev desuden overvejet og foreslået risikobegrænsende foranstaltninger vedrørende den konstaterede risiko over for gødningsinsekter.
Additionally, risk mitigation measures (RMM) have been considered and proposed for the risk identified for dung insects.
Fæces indeholdende epinomectin udskilt på marken af behandlede dyr, kan reducere mangfoldigheden af organismer, der lever af afføringen, hvilket kan påvirke nedbrydningen af afføringen.
Faeces containing eprinomectin excreted onto pasture by treated animals may reduce the abundance of dung feeding organisms which may impact on the dung degradation.
Denne indeholdt både offentliggjorte og af ansøgeren bestilte undersøgelser og omfattede samtlige miljørisikoaspekter.
An ERA in accordance with VICH and CVMP guidelines was provided which contained a mixture of published and bespoke studies from the applicant and addressed all aspects of environmental risk.
Styrke LÆGEMIDDELFORM Dyrearter Indgivelsesvej
Strength Pharmaceutical form
Indlægsseddel:
Package leaflet:
3 CVMP guideline on safety and residue data requirements for veterinary medicinal products intended for minor uses or minor species (EMEA/CVMP/SWP/418282/2005)http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/10/WC 500004581.pdf aktive indholdsstof til vurdering af stoffets skæbne og eventuelle effekter på organismer i miljøet ved anvendelse af produktet.
3 CVMP Guideline on environmental impact assessment for veterinary medicinal products in support of the VICH guidelines GL6 and GL38 (EMEA/CVMP/ERA/418282/2005)http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/10/WC 500004386.pdf for the active ingredient in order to assess the fate of the substance and the effects on organisms that might occur in the environment by the use of the product.
CVMP anbefalede derfor udstedelse af markedsføringstilladelse for Norbonex, pour-on, opløsning, 5 mg/ml, til kødkvæg og malkekvæg med ændring af referencemedlemsstatens produktresumé og indlægsseddel.
Therefore, the CVMP recommended the granting of the marketing authorisation for Norbonex 5 mg/ml Pour-On Solution for Beef and Dairy Cattle with amendment to the summary of product characteristics and package leaflet of the reference Member State.
Norbonex, pour-on, opløsning, 5 mg/ml, til kødkvæg og malkekvæg indeholder eprinomectin, der er et syntetisk avermectin.
Norbonex 5 mg/ml Pour-On Solution for Beef and Dairy Cattle contains eprinomectin, a synthetic avermectin.
VICH GL48: Guideline on environmental impact assessment (EIAs) for veterinary medicinal products - Phase I http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/10/WC 500004394.pdf
VICH GL38: Guideline on Environmental Impact Assessment for Veterinary Medicinal Products Phase II (CVMP/VICH/790/03)http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/10/WC 500004393.pdf
Miljørisikovurderingen overholdt fuldt ud datakravene.
The ERA was full and complete in terms of data requirements.
Der var forelagt en miljørisikovurdering for Norbonex, pour-on, opløsning, 5 mg/ml, til kødkvæg og malkekvæg, som var i overensstemmelse med VICH- og CVMP-retningslinjerne.
An ERA was provided for Norbonex 5 mg/ml Pour-On Solution for Beef and Dairy Cattle which was in accordance with VICH and CVMP guidelines.
Bilag 1
Annex I
På grundlag af de konstaterede risici i miljørisikovurderingen blev der foreslået risikobegrænsende foranstaltninger.
Based on the identified risks in the ERA RMM were proposed to address the risk.
Videnskabelige konklusioner og begrundelse for udstedelsen af markedsføringstilladelse for Norbonex, pour-on, opløsning, 5 mg/ml, til kødkvæg og malkekvæg
Scientific conclusions and grounds for the granting of the marketing authorisation for Norbonex 5 mg/ml Pour-On Solution for Beef and Dairy Cattle
Benefit/risk-forholdet anses for at være positivt for Norbonex, pour-on, opløsning, 5 mg/ml, til kødkvæg og malkekvæg.
The benefit-risk balance is considered positive for Norbonex 5 mg/ml Pour-On Solution for Beef and Dairy Cattle.
Samlet resumé af den videnskabelige vurdering af Norbonex, pour-on, opløsning, 5 mg/ml, til kødkvæg og malkekvæg
Overall summary of the scientific evaluation of Norbonex 5 mg/ml Pour-On Solution for Beef and Dairy Cattle
De risikobegrænsende foranstaltninger og advarslerne i produktresuméet og indlægssedlen varetager risikoen for gødningsfaunaen og akvatiske organismer gennem anvisninger om hyppigheden af genbehandling og om udskillelsesvarigheden for eprinomectin og om, at dyrene ikke må have adgang til vandområder i 2-5 uger efter behandlingen.
The RMM and warnings in the summary of product characteristics (SPC) and package leaflet address the risk to dung fauna and aquatic organisms by advising on the frequency of re-treatments, the
Begrundelse for udstedelsen af markedsføringstilladelsen for Norbonex, pour-on, opløsning, 5 mg/ml, til kødkvæg og malkekvæg
Grounds for the granting of the marketing authorisation for Norbonex 5 mg/ml Pour-On Solution for Beef and Dairy Cattle
Ansøgeren har ikke foreslået andre risikobegrænsende foranstaltninger på baggrund af miljørisikovurderingen.
On the basis of the ERA no other RMMs were proposed by the applicant.
MF (EU)-nummer
MA (EU) Number
Særnavn Styrke Lægemiddelform Administration Emballage
Strength Pharmaceutical form
Kontakt vores pressemedarbejder Monika Benstetter
Contact our press officer Monika Benstetter
GFR bør bestemmes før påbegyndelse af behandling og mindst én gang om året derefter.
GFR should be assessed before initiation of treatment and at least annually thereafter.
CHMP's udtalelse blev fremsendt til Europa-Kommissionen, som traf en endelig juridisk bindende beslutning med gyldighed i alle EU-medlemsstater den 12. december 2016.
The CHMP opinion was forwarded to the European Commission, which issued a final legally binding decision applicable in all EU Member States on 12/12/2016.
Gennemgangen af metforminholdige lægemidler blev iværksat den 28. januar 2016 på Nederlandenes foranledning, jf. artikel 31 i direktiv 2001/83/EF.
The review of metformin-containing medicines was initiated on 28 January 2016 at the request of the Netherlands, under Article 31 of Directive 2001/83/EC.
Yderligere oplysninger om centralt godkendte lægemidler findes her.
For further information about the centrally authorised medicines, see here.
Gennemgangen blev foretaget af Udvalget for Lægemidler til Mennesker (CHMP), som har ansvar for spørgsmål vedrørende lægemidler til mennesker, og som vedtog agenturets endelige udtalelse.
The review was carried out by the Committee for Medicinal Products for Human Use (CHMP), responsible for questions concerning medicines for human use, which adopted the Agency's opinion.
Tlf. +44 (0) 20 3660 8427 E-mail: press@ema.europa.eu
Tel. +44 (0)20 3660 8427 E-mail: press@ema.europa.eu
Desuden er kombinationen glibenclamid/metformin (Glucovance) godkendt nationalt.
In addition, the combination glibenclamide/metformin (Glucovance) has been nationally authorised.
• Hvis du har nogen spørgsmål eller bekymringer om din diabetesbehandling eller din nyrefunktion, skal du kontakte din læge, sygeplejerske eller apotekspersonalet.
• If you have any question or concern about your diabetes treatment or your kidney function level, speak with your doctor, nurse or pharmacist.
Hvis du oplever kraftig opkastning, diarré eller feber, er udsat for varme eller drikker mindre væske end normalt, kan du blive dehydreret.
If you experience severe vomiting, diarrhoea or fever, are exposed to heat, or drink less fluid than normal, you could become dehydrated.
• Adskillige fastdosis-kombinationsprodukter, der indeholder metformin, kan fås i Europa (se nedenfor).
• Several fixed-dose combination products containing metformin are available in Europe (see below).
• Dehydrering (betydeligt tab af kropsvæsker) øger risikoen for at udvikle laktatacidose.
• Dehydration (significant loss of body fluids) increases the risk of developing lactic acidosis.
Den aktuelle produktinformation er også forskellig fra land til land og fra lægemiddel til lægemiddel i EU og er ikke længere i overensstemmelse med kliniske retningslinjer.
The current product information also varies between countries and products in the EU and is no longer consistent with clinical guidelines.
Information til patienter
Information for patients
Produktinformationen indeholder også oplysninger om risikofaktorer for laktatacidose, der bør gennemgås før og under behandlingen.
The product information also details risk factors for lactic acidosis which should be reviewed prior to and during treatment.
Hvis det sker, skal du kortvarigt holde op med at tage metformin og kontakte din læge med henblik på yderligere vejledning.
In these cases, stop taking metformin for a short time and speak with your doctor for further instruction.
Lægemidler, der kun indeholder metformin, er blevet godkendt nationalt i EU siden 1960'erne under handelsnavnet Glucophage eller lignende.
Medicines containing metformin alone have been authorised nationally in the EU since the 1960s, marketed as Glucophage and other tradenames.
Anbefalinger for patienter med nedsat nyrefunktion opdateret i produktinformationen
Recommendations for patients with kidney impairment updated in product information
Klare doseringsanbefalinger og overvågning før og under behandling skal sikre, at en eventuel øget risiko hos disse patienter minimeres.
Clear dosing recommendations and monitoring before and during treatment aim to minimise any possible increased risk in these patients.
Efter at have gennemgået den videnskabelige litteratur, kliniske data, epidemiologiske undersøgelser og kliniske retningslinjer fra lægelige instanser er EMA imidlertid nået frem til, at den store patientpopulation med moderat nedsat nyrefunktion kan have gavn af metformin.
However, after considering the scientific literature, clinical data, epidemiological studies and clinical guidelines from medical bodies, EMA concluded that the large patient population with moderately reduced kidney function can benefit from use of metformin.
Virksomheder, der markedsfører metforminholdige lægemidler, vil blive bedt om nøje at overvåge og analysere fremtidige tilfælde af laktatacidose og indberette disse ved kommende periodiske sikkerhedsindberetninger med henblik på at følge op på eventuelle ændringer i hyppigheden af denne bivirkning.
Companies marketing metformin-containing medicines will be requested to closely monitor and analyse future lactic acidosis cases and report these during upcoming periodic safety reviews in order to follow up on any changes in the frequency of this side effect.
Produktinformationen for metforminholdige lægemidler vil blive opdateret, så den afspejler de nye anbefalinger, og så det sikres, at alle patienter i EU får den samme vejledning.
The product information for metformincontaining medicines will be updated to reflect the new recommendations and to ensure that the same advice is given to all patients in the EU.
Metformin kan øge risikoen for en sjælden, men alvorlig, komplikation, der hedder laktatacidose, og som optræder, når naturligt forekommende mælkesyre ophobes i blodet hurtigere, end det kan fjernes.
Metformin may increase the risk of a rare but serious complication called lactic acidosis, which occurs when naturally produced lactic acid builds up in the blood faster than it can be removed.
For eksempel er dapagliflozin/metformin (Ebymect, Xigduo) ikke anbefalet hos patienter med GFR < 60 ml/min; canagliflozin/metformin /Vokanamet) og empagliflozin/metformin (Synjardy) er ikke anbefalet hos patienter med GFR < 45 ml/min og bør ikke anvendes hos patienter med GFR < 60 ml/min.
For example, dapagliflozin/metformin (Ebymect, Xigduo) is not recommended in patients with GFR<60 ml/min; canagliflozin/metformin (Vokanamet) and empagliflozin/metformin (Synjardy) are not recommended in patients with GFR<45 ml/min and should not be started in patients with GFR<60 ml/min.
Metformin er et lægemiddel, der bruges alene eller i kombination med andre lægemidler til behandling af type 2-diabetes.
Metformin is a medicine used on its own or in combination with other medicines for the treatment of type 2 diabetes.
Information til sundhedspersoner
Information for healthcare professionals
I den aktuelle produktinformation står der, at metformin ikke må anvendes hos patienter med nedsat nyrefunktion, da disse patienter anses for at have en højere risiko for at udvikle laktatacidose, idet deres nyrer ikke fjerner metformin tilstrækkeligt effektivt.
Currently, the product information states that metformin must not be used in patients with reduced kidney function because these patients are considered to be at a higher risk of developing lactic acidosis as their kidneys do not remove metformin efficiently enough.
Metformindosen bør tilpasses patientens nyrefunktion.
The dose of metformin should be adapted depending on the patient's kidney function.
Følgende lægemidler, der indeholder en kombination af metformin og andre aktive stoffer i samme tablet, er godkendt centralt af EMA: pioglitazon/metformin (Competact, Glubrava), dapagliflozin/metformin (Ebymect, Xigduo), sitagliptin/metformin (Efficib, Janumet, Ristfor, Velmetia), linagliptin/metformin (Jentadueto), saxagliptin/metformin (Komboglyze), alogliptin/metformin (Vipdomet), canagliflozin/metformin (Vokanamet), vildagliptin/metformin (Eucreas, Icandra, Zomarist) og empagliflozin/metformin (Synjardy).
The following medicines containing combinations of metformin with other diabetes medicines in the same tablet have been authorised centrally through EMA: pioglitazone/metformin (Competact, Glubrava), dapagliflozin/metformin (Ebymect, Xigduo), sitagliptin/metformin (Efficib, Janumet, Ristfor, Velmetia), linagliptin/metformin (Jentadueto), saxagliptin/metformin (Komboglyze), alogliptin/metformin (Vipdomet), canagliflozin/metformin (Vokanamet), vildagliptin/metformin (Eucreas, Icandra, Zomarist) and empagliflozin/metformin (Synjardy).
Hvis disse produkter anvendes hos patienter med nedsat nyrefunktion, bør man overveje restriktionerne for og virkningen af det andet aktive stof i kombinationen, muligheden for dosisjustering og alternativet med brug af enkeltstoftabletter.
If these products are used in patients with reduced kidney function, restrictions and efficacy regarding the other active substance in the combination, the feasibility of dose adjustment and the alternative of using individual tablets should be considered.
• Nogle fastdosis-kombinationsprodukter er stadig ikke anbefalede hos patienter med nedsat nyrefunktion, fordi det andet aktive stof i kombinationen ikke bør anvendes hos disse patienter.
• Some fixed-dose combination products are still not recommended in patients with moderately reduced kidney function because the other active substance in the combination should not be used in these patients.
Litteraturhenvisninger
References
• Patienter med nedsat nyrefunktion kan have en højere risiko for laktatacidose, der er en sjælden, men alvorlig bivirkning ved metforminholdige lægemidler, som skyldes ophobning af mælkesyre i blodet.
• Patients with reduced kidney function may be at higher risk of lactic acidosis, a rare but serious side effect of metformin medicines caused by build-up of lactic acid in the blood.
Brugen hos patienter med en GFR < 30 ml/min er stadig kontraindiceret.
Use in patients with GFR<30 ml/min is still contraindicated.
Produktinformationen for disse lægemidler vil blive opdateret for så vidt angår den aktuelle kontraindikation, og der vil blive givet oplysninger om doser, overvågning og forsigtighedsregler hos patienter med nedsat nyrefunktion.
The product information for these medicines will be updated to revise the current contraindication and give information about doses, monitoring and precautions in patients with reduced kidney function.
Anbefalingerne er et resultat af EMA's gennemgang af metforminholdige lægemidler som følge af bekymringer over, at den aktuelle videnskabelige evidens ikke berettiger en kontraindikation hos patienter med moderat nedsat nyrefunktion.
The recommendations were the result of a review by EMA of metformin-containing medicines following concerns that current scientific evidence does not justify a contraindication in patients with moderate reduction of kidney function.
Roussel, R. et al., "Metformin use and mortality among patients with diabetes and atherothrombosis", Arch Intern Med, 2010, Vol. 170, s. 1892.
Roussel, R. et al., ‘Metformin use and mortality among patients with diabetes and atherothrombosis', Arch Intern Med, 2010, Vol. 170, p. 1892.
• Reducering af dosis bør overvejes hos patienter med moderat nedsat nyrefunktion i henhold til doseringsanbefalingerne i den opdaterede produktinformation.
• Reduced doses should be considered for patients with moderate reduction of kidney function according to dosage recommendations provided in the updated product information.
• Disse seneste anbefalinger vil medføre en harmonisering af produktinformationen for brug af metformin hos patienter med nedsat nyrefunktion og forsigtighedsregler vedrørende laktatacidose i hele EU.
• These latest recommendations will result in harmonisation of product information about the use of metformin in patients with reduced kidney function and the precautions for lactic acidosis across the EU.
• Metformin bruges alene eller sammen med andre lægemidler i tillæg til kost og motion til behandling af type 2-diabetes.
• Metformin is used on its own or with other medicines, together with diet and exercise, for the treatment of type 2 diabetes.
• Indtil nu har metforminholdige lægemidler ikke været anbefalet til patienter med moderat til svært nedsat nyrefunktion.
• Up to now, metformin medicines were not recommended for patients with moderate to severe reduction of kidney function.
Den 13. oktober 2016 konkluderede Det Europæiske Lægemiddelagentur (EMA), at metforminholdige lægemidler nu kan anvendes hos patienter med moderat nedsat nyrefunktion (glomerulær filtrationshastighed (GFR) = 30-59 ml/min) til behandling af type 2-diabetes.
On 13 October 2016, the European Medicines Agency (EMA) concluded that metformin-containing medicines can now be used in patients with moderately reduced kidney function (GFR [glomerular filtration rate] = 30-59 ml/min) for the treatment of type 2 diabetes.
For de patienter, der blot har en moderat nedsat nyrefunktion, kan en eventuel risiko dog minimeres ved nøje at tilpasse dosis og overvåge for eventuelle bivirkninger, således at disse patienter også kan få gavn af disse lægemidler.
However, for patients with only moderately reduced kidney function any risk can be minimised by careful checking of dose and monitoring, allowing these patients to get the benefits these medicines can provide.
Solini, A. et al., "Age, renal dysfunction, cardiovascular disease, and antihyperglycemic treatment in type 2 diabetes mellitus: findings from the Renal Insufficiency and Cardiovascular Events Italian Multicenter Study", J Am Geriatr Soc, 2013, Vol. 61, s. 1253.
Solini, A. et al., ‘Age, renal dysfunction, cardiovascular disease, and antihyperglycemic treatment in type 2 diabetes mellitus: findings from the Renal Insufficiency and Cardiovascular Events Italian Multicenter Study', J Am Geriatr Soc, 2013, Vol. 61, p. 1253.
Metformin anvendes i tillæg til kost og motion for at forbedre reguleringen af blodsukkeret.
Metformin is used together with diet and exercise to improve control of blood glucose (sugar) levels.
et al., "Metformin in patients with type 2 diabetes and kidney disease: a systematic review", JAMA, 2014, Vol. 312, s. 2668.
et al., ‘Metformin in patients with type 2 diabetes and kidney disease: a systematic review', JAMA, 2014, Vol. 312, p. 2668.
Gennemgangen omfattede data fra en lang række undersøgelser, herunder: Ekström, N. et al., "Effectiveness and safety of metformin in 51675 patients with type 2 diabetes and different levels of renal function: a cohort study from the Swedish National Diabetes Register", BMJ Open, 2012, 2:e001076.
Ekström, N. et al., ‘Effectiveness and safety of metformin in 51675 patients with type 2 diabetes and different levels of renal function: a cohort study from the Swedish National Diabetes Register', BMJ Open, 2012, 2:e001076.
• Gennemgangen af metforminholdige lægemidler har vist, at de nu kan anvendes hos patienter med moderat nedsat nyrefunktion (GFR = 30-59 ml/min).
• The review of metformin-containing medicines concluded that they can now be used in patients with moderately reduced kidney function (GFR=30-59 ml/min).
et al., "Risk of lactic acidosis or elevated lactate concentrations in metformin users with renal impairment: A population-based cohort study", Diabetes Care, 2014, Vol. 37 (8), s. 2218.
et al., ‘Risk of lactic acidosis or elevated lactate concentrations in metformin users with renal impairment: A population-based cohort study', Diabetes Care, 2014, Vol. 37 (8), p. 2218.
Kontraindikationen for patienter med svært nedsat nyrefunktion fastholdes (GFR mindre end 30 ml/min).
The contraindication for patients with severely reduced kidney function will remain (GFR less than 30 ml/min).
Disse lægemidler bør ikke bruges hos patienter med svært nedsat nyrefunktion (GFR mindre end 30 ml/min).
These medicines should still not be used in patients with severely reduced kidney function (GFR less than 30 ml/min).
Denne anbefaling er nu blevet ændret, så de godt må anvendes hos patienter med moderat nedsat nyrefunktion (GFR = 30-59 ml/min).
This recommendation has now changed to allow their use in patients with moderately reduced kidney function (GFR=30-59 ml/min).
et al., "Incidence of lactic acidosis in patients with type 2 diabetes with and without renal impairment treated with metformin: a retrospective cohort study", Diabetes Care, 2014, Vol. 37 (8), s. 2291.
et al., ‘Incidence of lactic acidosis in patients with type 2 diabetes with and without renal impairment treated with metformin: a retrospective cohort study', Diabetes Care, 2014, Vol. 37 (8), p.
Yderligere information om lægemidlet
More about the medicine
Poliovirus (inaktiveret)3 Type 1 (Mahoney)
Poliovirus (Inactivated)3 Type 1 (Mahoney)
3 Produceret på Vero-celler
3 Produced on Vero cells
1 Adsorberet på aluminiumhydroxid, hydreret (0,6 mg Al3+) 2 Som nedre konfidensgrænse (p= 0,95)
1 Adsorbed on aluminium hydroxide, hydrated (0.6 mg Al3+) 2 As lower confidence limit (p= 0.95)
4 Eller ækvivalent antigen-mængde efter en passende immunokemisk metode 5 Fremstillet i Hansenula polymorpha gærceller ved hjælp af rekombinant DNA-teknologi
4 Or equivalent antigenic quantity determined by a suitable immunochemical method 5 Produced in yeast Hansenula polymorpha cells by recombinant DNA technology
Haemophilus influenzae type b polysaccharid
Haemophilus influenzae type b polysaccharide
Hepatitis B overfladeantigen5
Hepatitis B surface antigen5
Bordetella pertussis antigener Pertussis toxoid
Bordetella pertussis antigens Pertussis Toxoid
--1 En dosis1 (0,5 ml) indeholder: Difteri toxoid
--1 One dose1 (0.5 ml) contains: Diphtheria Toxoid
(Polyribosylribitolphosphat) konjugeret til tetanus protein
(Polyribosylribitol Phosphate) conjugated to Tetanus protein
Paknings-størrelse
Immediate Packaging
Filamentøs hæmagglutinin
Filamentous Haemagglutinin
Fyldt sprøjt
1 pre-filled syringe
• nye neoplasmer
• New neoplasm