FrancophonIA/ELRC3.0 huggingface dataset:
English: It has been observed in rare cases that upon withdrawal of Yellox, a flare-up of the inflammatory response, e.g. in the form of macular oedema, due to the cataract operation may occur.
Danish: I sjældne tilfælde er der ved behandlingsophør med Yellox blevet observeret en opblussen af det inflammatoriske respons f.eks. i form af macular ødem efter operation for grå stær.
English: Wearing contact lenses is not recommended after cataract surgery.
Danish: Det frarådes at bruge kontaktlinser efter en kataraktoperation.
English: How to use Yellox
Danish: Sådan skal du bruge Yellox
English: Eye irritation
Danish: Øjenirritation
English: Photophobia
Danish: Fotofobi
English: Yellox 0.9 mg/ ml eye drops, solution bromfenac
Danish: Yellox 0,9 mg/ ml øjendråber, opløsning bromfenac
English: Hypersensitivity to bromfenac or to any of the excipients listed in section 6.1, or to other nonsteroidal anti-inflammatory medicinal products (NSAIDs).
Danish: 6.1 eller andre non-steroide anti-inflammatoriske lægemidler (NSAID).
English: Tel.: +420 234 719 600
Danish: Tlf.: +420 234 719 600
English: What Yellox is and what it is used for What you need to know before you use Yellox How to use Yellox
Danish: Det skal du vide, før du begynder at bruge Yellox Sådan skal du bruge Yellox Bivirkninger
English: Excipients
Danish: Øjenkløe
English: Eye redness
Danish: Øjenlågsødem
English: Yellox 0.9 mg/ml eye drops solution
Danish: Yellox 0,9 mg/ml øjendråber, opløsning
English: Yellox is for ocular use.
Danish: Administration (indgivelse) Yellox er til okulær brug (i øjnene).
English: If you use more Yellox than you should
Danish: Hvis du har brugt for meget Yellox
English: 7 days.
Danish: 7 dage.
English: Take off any contaminated clothes.
Danish: Kontamineret tøj tages af.
English: It is recommended that product is used not more than twice in one year.
Danish: Det anbefales at produktet ikke anvendes oftere end to gange årligt.
English: However, the administration may be repeated, depending on the epidemiological situation in different areas.
Danish: Indgift kan imidlertid gentages, afhængig af den epidemiologiske situation i forskellige geografiske områder.
English: Isolated cases of resistance against monepantel have been identified within the European Union.
Danish: Enkelte tilfælde af resistens over for monepantel er set i den Europæiske Union.
English: Afterwards blood concentrations decrease with a half life of about five days.
Danish: Derefter aftager koncentrationen i blodet med en halveringstid på ca. fem dage.
English: • Too frequent and repeated use of anthelmintics from the same class, over an extended period of time.
Danish: • For hyppig og gentagen brug af anthelmintika fra samme klasse over længere tid.
English: Excretion is mainly via the faeces but also via the urine.
Danish: Udskillelse sker primært via fæces, men også via urinen.
English: Care should be taken to avoid the following practices because they increase the risk of development of resistance and could ultimately result in ineffective therapy:
Danish: Følgende fremgangsmåder bør undgås, da de øger risikoen for udviklingen af resistens og i sidste ende kan medføre ineffektiv behandling:
English: 1 ml for each additional 10 kg
Danish: 1 ml for hver yderligere 10 kg
English: DATE OF REVISION OF THE TEXT {MM/YYYY}
Danish: 10 DATO FOR ÆNDRING AF TEKSTEN {MM/ÅÅÅÅ}
English: Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu/.
Danish: Nærmere oplysninger om dette veterinærlægemiddel er tilgængelige på webstedet for Det Europæiske Lægemiddelagentur (EMA) http://www.ema.europa.eu/.
English: Interaction with other medicinal products and other forms of interaction: No interaction with other medicinal products and other forms of interaction are known.
Danish: Interaktion med andre lægemidler og andre former for interaktion: Ingen interaktion med andre lægemidler og andre former for interaktion er kendt.
English: Wash hands and exposed skin after handling the veterinary medicinal product.
Danish: Vask hænder og eksponeret hud efter håndtering af lægemidlet.
English: To ensure administration of a correct dose, bodyweight should be determined as accurately as possible.
Danish: For at sikre indgift af korrekt dosis skal legemsvægt bestemmes så nøjagtigt som muligt.
English: Antiparasitic agents/ Agents acting against endoparasites
Danish: Antiparasitære forbindelser/forbindelser der virker mod endoparasitter
English: In case of accidental spillage onto skin or into eyes, wash immediately with water.
Danish: Ved utilsigtet spild på huden eller i øjnene skal der straks vaskes med vand.
English: Peak blood concentrations are reached within a day.
Danish: Maksimale koncentrationer i blodet nås inden for en dag.
English: Not authorised for use in animals producing milk for human consumption.
Danish: Ikke godkendt til brug til dyr, der producerer mælk til konsum.
English: The excipients listed in section 6.1 of the SPC are either allowed substances for which table 1 of the annex to Commission Regulation (EU) No 37/2010 indicates that no MRLs are required or are considered as not falling within the scope of Regulation (EC) No 470/2009 when used as in this product.
Danish: Hjælpestofferne anført under punkt 6.1 i SPC'et er enten tilladte hjælpestoffer, hvor tabel 1 i bilaget til Kommissionens forordning (EU) Nr. 37/2010 indikerer, at MRL-værdier ikke er påkrævet, eller som ikke anses for at være omfattet af Forordning (EC) nr. 470/2009, når de anvendes i et veterinærlægemiddel.
English: Medicines should not be disposed of via wastewater or household waste.
Danish: Lægemidler må ikke bortskaffes sammen med spildevand eller husholdningsaffald.
English: Spectrum of activity includes fourth larvae and adults of:
Danish: Virkningsspektrum inkluderer fjerde larvestadium og voksenstadium af:
English: Personal protective equipment consisting of gloves should be worn when handling the veterinary medicinal product.
Danish: Personligt beskyttelsesudstyr i form af beskyttelseshandsker bør anvendes ved håndtering af lægemidlet.
English: If animals are to be treated collectively rather than individually, they should be grouped according to their bodyweight and dosed according to the heaviest animal within the group in order to avoid underdose.
Danish: Hvis dyr skal behandles samlet frem for enkeltvist, skal de grupperes i henhold til deres legemsvægt og doseres efter det tungeste dyr i gruppen for at undgå underdosering.
English: 27472 Cuxhaven Germany
Danish: 27472 Cuxhaven
English: Marketing authorisation holder: Elanco GmbH
Danish: Indehaver af markedsføringstilladelsen: Elanco GmbH
English: • Underdosage, which may be due to underestimation of body weight, misadministration of the product, or lack of calibration of the dose device.
Danish: • Underdosering, som kan skyldes undervurdering af legemsvægten, forkert indgift af lægemidlet eller manglende kalibrering af doseringsenheden.
English: Feeding or fasting before or shortly after treatment does not influence efficacy.
Danish: Effektiviteten påvirkes ikke af fodring eller faste før eller kort tid efter behandlingen.
English: THE WORDS “FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE, IF APPLICABLE
Danish: TEKSTEN "KUN TIL DYR" SAMT BETINGELSER ELLER BEGRÆNSNINGER FOR UDLEVERING OG BRUG, OM NØDVENDIGT
English: Drenching equipment should be cleaned after use.
Danish: Doseringsudstyret skal rengøres efter brug.
English: Therapeutic classification
Danish: Terapeutisk klassifikation
English: This is the first biological function to be described for the Hco-MPTL-1 receptor and therefore monepantel is effective against nematodes resistant to other anthelmintic classes.
Danish: Dette er den første biologiske funktion, der beskrives for Hco-MPTL-1-receptoren, og monepantel er derfor virksom over for nematoder, der er resistente over for andre anthelmintika.
English: Do not eat, drink or smoke whilst handling the veterinary medicinal product.
Danish: Der må ikke spises, drikkes eller ryges under brugen af lægemidlet.
English: Ask your veterinary surgeon how to dispose of medicines no longer required.
Danish: Kontakt Deres dyrlæge vedrørende bortskaffelse af lægemidler, der ikke længere findes anvendelse for.
English: Shelf life of the veterinary medicinal product as packaged for sale: Bottle (HDPE): 3 years
Danish: Opbevaringstid for veterinærlægemidlet i salgspakning: Flaske (HDPE): 3 år.
English: Increasing refugia (i.e. a source of parasites which have not been exposed to the anthelmintic) has been demonstrated to delay the development of resistance.
Danish: Det er blevet påvist at øgning af størrelsen af parasitrefugiet (dvs. populationen af parasitter der ikke har været eksponeret for det pågældende anthelmintikum) forsinker resistensudviklingen.
English: Accuracy and proper functioning of the dose device should be checked.
Danish: Det skal kontrolleres, at doseringsudstyret fungerer præcist og korrekt.
English: STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENTS
Danish: ANGIVELSE AF DE(T) AKTIVE STOF(FER) OG ANDRE INDHOLDSSTOFFER
English: WITHDRAWAL PERIOD(S) 7 days.
Danish: TILBAGEHOLDELSESTID(ER) 7 dage
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Active substance:
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING
English: To assure complete swallowing of this low volume solution, administer orally on the back of the tongue.
Danish: For at sikre fuldstændig synkning af denne opløsning med lille volumen, indgives den oralt bagerst på tungen.
English: Special warnings for each target species:
Danish: Særlige advarsler for hver dyreart:
English: Overdose (symptoms, emergency procedures, antidotes): No adverse effects were observed after a 10-fold overdose.
Danish: Overdosis (symptomer, nødforanstaltninger, modgift): Der er ikke observeret bivirkninger efter 10 x overdosering.
English: The active substance in ZOLVIX is an allowed substance as described in table 1 of the annex to Commission Regulation (EU) No 37/2010:
Danish: C. ANGIVELSE AF MRL-VÆRDIER De aktive substans i ZOLVIX er godkendt substans som beskrevet i tabel 1 i bilag til Kommissionens Forordning (EU) Nr. 37/2010: Farmakologisk aktiv stof(fer)
English: In order to help delay the development of resistance, users are advised to check the success of the treatment (e.g. clinical appearance, faecal egg counts).
Danish: For at forsinke udviklingen af resistens rådes brugerne til at kontrollere behandlingens succes (f.eks. klinisk udseende, ægtælling i fæces).
English: After oral administration monepantel is readily absorbed and oxidised to a sulfone metabolite.
Danish: Monepantel absorberes hurtigt ved oral indgift og oxideres til en sulfon metabolit.
English: However, this should be considered only after advice has been taken from an animal health advisor.
Danish: Dette bør først overvejes efter samråd med dyrlægen.
English: Suspected clinical cases of resistance to anthelmintics should be further investigated using appropriate tests (e.g. Faecal Egg Count Reduction Tests) in discussion with their animal health advisor.
Danish: Formodede kliniske tilfælde af resistens over for anthelmintika bør undersøges yderligere ved hjælp af egnede test (f.eks. Faecal Egg Count Reduction Test) i samråd med dyrlægen.
English: Shelf life after first opening the immediate packaging: 1 year
Danish: Opbevaringstid efter første åbning af den indre emballage: 1 år.
English: For the full list of excipients, see section 6.1.
Danish: Se afsnit 6.1 for en fuldstændig fortegnelse over hjælpestoffer.
English: Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.
Danish: Eventuelle ubrugte lægemidler eller affald fra sådanne skal destrueres i overensstemmelse med de lokale krav.
English: Monepantel is an anthelmintic belonging to the amino-acetonitrile derivative (AAD) class of molecules.
Danish: Monepantel er et anthelmintika, der tilhører amino-acetonitril derivat (AAD) gruppen af molekyler.
English: Orange clear solution.
Danish: Oral opløsning Orange, klar opløsning
English: Pack sizes of 250 ml, 500 ml, 1 l, 2.5 l, and 5 l Not all pack sizes may be marketed.
Danish: Pakningsstørrelser på 250 ml, 500 ml, 1 l, 2,5 l og 5 l. Ikke alle pakningsstørrelser er nødvendigvis markedsført.
English: Special precautions to be taken by the person administering the veterinary medicinal product to animals:
Danish: Særlige forholdsregler der skal træffes af personer, der administrerer lægemidlet til dyr:
English: Elanco GmbH Heinz-Lohmann-Str. 4 27472 Cuxhaven Germany
Danish: Elanco GmbH Heinz-Lohmann-Str. 4 27472 Cuxhaven Tyskland
English: Special precautions for use in animals: The safety has not been established in sheep weighing less than 10 kg or under 2 weeks of age.
Danish: Special forholdsregler til brug hos dyr: Sikkerheden er ikke fastslået hos får, som vejer mindre end 10 kg eller er under 2 uger gamle.
English: Monepantel acts on the nematode specific nicotinic acetylcholine receptor sub-unit HcoMPTL-1.
Danish: Monepantel virker på den nematode-specifikke nikotinerge acetylkolin-receptor-subunit Hco-MPTL1.
English: In addition, the product was shown to be effective against 4th stage larvae of a strain of H. contortus in a laboratory study where a combination of abamectin with derquantel was not effective.
Danish: I et laboratoriestudie blev det desuden vist, at produktet er effektivt over for stadie 4 larver af en stamme af H. contortus, hvor en kombination af abamectin og derquantel ikke var effektivt.
English: Argenta Dundee Limited Kinnoull Road Dunsinane Industrial Estate Dundee, DD2 3XR United Kingdom
Danish: Argenta Dundee Limited Kinnoull Road Dunsinane Industrial Estate Dundee, DD2 3XR Storbritannien
English: The veterinary medicinal product can be used in breeding sheep including pregnant and lactating ewes.
Danish: Veterinærlægemidlet kan bruges til avlsfår, herunder drægtige og diegivende får.
English: The dose is 2.5 mg/kg bodyweight of monepantel.
Danish: Dosis er 2,5 mg monepantel/kg legemsvægt.
English: ATCvet code: QP52AX09.
Danish: Farmakoterapeutisk gruppe: anthelmintika, ATCvet-kode: QP52AX09.
English: Where the results of the tests strongly suggest resistance to a particular anthelmintic, an anthelmintic belonging to another pharmacological class and having a different mode of action should be used.
Danish: Hvor resultaterne af testene tydeligt viser resistens over for et bestemt anthelmintikum, skal der bruges et anthelmintikum, som tilhører en anden farmakologisk klasse, og som har en anden virkningsmekanisme.
English: Pregnancy and lactation: Can be used in breeding sheep including pregnant and lactating ewes.
Danish: Drægtighed og laktation: Kan bruges til avlsfår, herunder drægtige og diegivende får.
English: In case of accidental ingestion seek medical advice immediately and show the package leaflet or the label to the physician.
Danish: I tilfælde af utilsigtet indgift skal der straks søges lægehjælp, og indlægssedlen eller etiketten bør vises til lægen.
English: Fluorinated high density polyethylene (HDPE) bottles with a polypropylene cap.
Danish: Flasker af fluoreret højdensitetspolyethylen (HDPE) med polypropylen-hætte
English: Macrogolglycerol hydroxystearate Polysorbate 80
Danish: Ricinusolie, polyoxyleret, hydrogeneret Polysorbat 80
English: Elanco France S.A.S 26 Rue de la Chapelle F-68330 Huningue France
Danish: 26 Rue de la Chapelle F-68330 Huningue Frankrig
English: The veterinary medicinal product is administered as a single treatment.
Danish: Lægemidlet indgives som en enkelt behandling.
English: EXPIRY DATE EXP {month/year} Once opened use within 1 year.
Danish: Efter åbning anvendes inden for 1 år.
English: ZOLVIX oral solution is a broad spectrum anthelmintic for the treatment and control of gastrointestinal nematode infections and associated diseases in sheep including lambs, hoggets, breeding rams and ewes.
Danish: ZOLVIX oral opløsning er et bredspektret anthelmintikum til behandling og kontrol af nematodeinfektioner i mave-tarmkanalen og tilknyttede sygdomme hos får, herunder lam, slagtelam og avlsdyr.
English: Pack sizes of 250 ml, 500 ml, 1 l, 2.5 l, and 5 l.
Danish: Pakningsstørrelser på 250 ml, 500 ml, 1 l, 2,5 l og 5 l.
English: For any information about this veterinary medicinal product, please contact the marketing authorisation holder.
Danish: De bedes kontakte indehaveren af markedsføringstilladelsen, hvis De ønsker yderligere oplysninger om dette lægemiddel.
English: The safety has not been established in sheep weighing less than 10 kg or under 2 weeks of age.
Danish: Sikkerheden er ikke fastslået hos får, der vejer mindre end 10 kg eller er under 2 uger gamle.
English: CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
Danish: BETINGELSER ELLER BEGRÆNSNINGER VEDRØRENDE UDLEVERING OG BRUG.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE AND IMMEDIATE PACKAGE Cardboard box and HDPE bottle
Danish: OPLYSNINGER, DER SKAL ANFØRES PÅ DEN YDRE OG INDRE EMBALLAGE Kartonæske og HDPE-flaske
English: This veterinary medicinal product does not require any special storage conditions.
Danish: Der er ingen særlige forholdsregler vedrørende opbevaringen.
English: STATEMENT OF ACTIVE SUBSTANCES Each ml contains 25 mg of monepantel
Danish: Aktivt stof: Hver ml indeholder 25 mg monepantel
English: ZOLVIX was shown to be effective against strains of gastro-intestinal parasites, listed in section 4.2, resistant to (pro)benzimidazoles, levamisole, morantel, macrocyclic lactones and H. contortus strains resistant to salicylanilides.
Danish: Zolvix blev vist at være effektivt over for stammer af gastro-intestinale parasitter nævnt under 4.2, der er resistente over for (pro)benzimidazoler, levamisol, morantel, makrocykliske lactoner og H.contortus stammer resistente over for salicylanilider.
English: Name and address of the manufacturers responsible for batch release
Danish: Navn og adresse på fremstillerne ansvarlig for batchfrigivelse
English: ZOLVIX was shown to be effective against strains of gastro-intestinal parasites, listed in section 4, resistant to (pro)benzimidazoles, levamisole, morantel, macrocyclic lactones and H. contortus strains resistant to salicylanilides.
Danish: Zolvix blev vist at være effektivt over for stammer af de gastro-intestinale parasitter nævnt under punkt 4, der er resistente over for (pro)benzimidazoler, levamisol, morantel, makrocykliske lactoner og H.contortus stammer resistente over for salicylanilider.
English: The efficacy has not been established in sheep weighing less than 10 kg.
Danish: Effekten er ikke fastslået hos får, der vejer mindre end 10 kg.
English: WITHDRAWAL PERIOD(S)
Danish: 10. TILBAGEHOLDELSESTID(ER)
English: 4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary No adverse effects were observed after a 10-fold overdose.
Danish: 4.10 Overdosering (symptomer, nødforanstaltninger, modgift), om nødvendigt
English: A. MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE
Danish: A. FREMSTILLER(E) ANSVARLIG FOR BATCHFRIGIVELSE
English: * including inhibited larvae
Danish: *Inklusiv hvilende larvestadier
English: DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION Dose table Bodyweight, kg
Danish: DOSERING FOR HVER DYREART, ANVENDELSESMÅDE OG INDGIVELSESVEJ(E)
English: SPECIAL STORAGE PRECAUTIONS Keep out of the sight and reach of children.
Danish: Opbevares utilgængeligt for børn.
English: Liver Kidney Milk
Danish: Muskler Fedt Lever Nyrer Mælk
English: Propylene glycol monocaprylate Propylene glycol dicaprylocaprate
Danish: Propylenglycolmonocaprylat Propylenglycoldicaprylocaprat
English: Each ml of ZOLVIX orange clear oral solution contains 25 mg of monepantel
Danish: Hver ml ZOLVIX oral opløsning indeholder 25 mg monepantel
English: 4.3 Contraindications
Danish: 4.3 Kontraindikationer Ingen.
English: United Kingdom and
Danish: Tyskland
English: MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE
Danish: FREMSTILLER(E) ANSVARLIG FOR BATCHFRIGIVELSE
English: NAME OF THE VETERINARY MEDICINAL PRODUCT ZOLVIX 25 mg/ml oral solution for sheep Monepantel
Danish: VETERINÆRLÆGEMIDLETS NAVN ZOLVIX 25 mg/ml oral opløsning til får Monepantel
English: Each ml contains 25 mg of monepantel Excipient:
Danish: Hver ml indeholder 25 mg monepantel
English: Incompatibilities:
Danish: Uforligeligheder.
English: Other ingredients:
Danish: Hjælpestoffer:
English: B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY OR USE Veterinary medicinal product subject to prescription.
Danish: B. BETINGELSER ELLER BEGRÆNSNINGER VEDRØRENDE UDLEVERING OG BRUG.
English: PHARMACEUTICAL FORM Oral solution
Danish: LÆGEMIDDELFORM
English: SPECIAL WARNING(S)
Danish: SÆRLIG(E) ADVARSEL/ADVARSLER
English: Manufacturer responsible for batch release: Argenta Dundee Limited Kinnoull Road
Danish: Fremstiller af batchfrigivelse: Argenta Dundee Limited Kinnoull Road Dunsinane Industrial Estate Dundee, DD2 3XR Storbritannien og
English: PACKAGE LEAFLET: ZOLVIX 25 mg/ml oral solution for sheep
Danish: ZOLVIX 25 mg/ml oral opløsning til får
English: THE WORDS “KEEP OUT OF THE SIGHT AND REACH OF CHILDREN” Keep out of the sight and reach of children.
Danish: TEKSTEN "OPBEVARES UTILGÆNGELIGT FOR BØRN"
English: NAME OF THE VETERINARY MEDICINAL PRODUCT ZOLVIX 25 mg/ml oral solution for sheep
Danish: INDLÆGSSEDDEL ZOLVIX 25 mg/ml oral opløsning til får
English: Body weight, kg
Danish: Doseringstabel Legemsvægt
English: 6.4 Special precautions for storage
Danish: EVENTUELLE SÆRLIGE FORHOLDSREGLER VEDRØRENDE OPBEVARING
English: 4.1 Target species
Danish: 4.1 Dyrearter, som lægemidlet er beregnet til Får
English: Pharmacologically active substance(s)
Danish: ANGIVELSE AF AKTIVE STOFFER
English: Disposal: read the package leaflet.
Danish: Læs indlægssedlen inden brug.
English: Dose, ml
Danish: UDL.D {måned/år}
English: TARGET SPECIES
Danish: Restmarkør Dyrearter
English: However, as the DNA damage mechanisms documented in these studies are also relevant in humans and in vitro data in human cells are not significantly different from those in animal cells, it is prudent to assume that effects seen in animals may also occur in humans after exposure to sufficiently large amounts of these nitrosamines.
Danish: Da de DNA-skadelige mekanismer, der er dokumenteret i disse studier, imidlertid også er relevante hos mennesker, og in vitro-data for menneskeceller ikke er væsentligt forskellige fra in vitrodata for dyreceller, er det rimeligt at antage, at virkninger set hos dyr også kan forekomme hos mennesker efter eksponering for tilstrækkeligt store mængder af disse nitrosaminer.
English: For example, a recent review has estimated risks of perforation of 4 per 10,000 (95% confidence interval, 2-5) and major haemorrhage of 8 per 10,000 (95% confidence interval, 5-14) with screening colonoscopy.
Danish: For eksempel har en nylig gennemgang skønnet risikoen for perforation til 4 ud af 10.000 tilfælde (95 %-konfidensinterval: 2-5) og for alvorlig blødning til 8 ud af 10.000 (95 %konfidensinterval: 5-14) ved screeningskoloskopi.
English: In comparison to the daily intake levels calculated based on ICH M7(R1) using non-clinical toxicology, it is possible to generate additional safety factors ranging from 2.73 - 27.3 for NDMA and 10.0 - 100 for NDEA, by defining 0.03 ppm as the common technical target limit for NDEA and NDMA in tetrazole sartan APIs.
Danish: I forhold til niveauet af det daglige indtag, der er beregnet på grundlag af ICH M7 (R1) ved hjælp af non-klinisk toksikologi, er det muligt at generere yderligere sikkerhedsfaktorer i intervallet 2,73-27,3 for NDMA og 10,0-100 for NDEA ved at definere 0,03 ppm som den fælles tekniske målværdi for NDEA og NDMA i aktive stoffer, der indeholder sartan med en tetrazolring.