FrancophonIA/ELRC3.0 huggingface dataset:
English: Overall summary of the scientific evaluation of veterinary medicinal products containing tylosin that are administered parenterally and intended for the treatment of bovine mastitis caused by Mycoplasma spp.
Danish: Samlet resumé af den videnskabelige vurdering af veterinærlægemidler, der indeholder tylosin, administreres parenteralt og er bestemt til behandling af bovin mastitis forårsaget af Mycoplasma spp.
English: the CVMP has recommended the variation of the marketing authorisations for veterinary medicinal products containing tylosin that are administered parenterally and intended for the treatment of bovine mastitis caused by Mycoplasma spp.
Danish: anbefalede CVMP ændring af markedsføringstilladelserne for veterinærlægemidler indeholdende tylosin, der administreres parenteralt og er bestemt til behandling af bovin mastitis forårsaget af Mycoplasma spp.
English: Finland noted that there are veterinary medicinal products containing tylosin that are administered parenterally and intended for the treatment of bovine mastitis caused by Mycoplasma spp.
Danish: Finland bemærkede, at der findes veterinærmedicinske produkter, der indeholder tylosin, administreres parenteralt, er bestemt til behandling af bovin mastitis forårsaget af Mycoplasma spp.
English: For the same reasons sensitivity testing of Mycoplasma spp.
Danish: Dette vanskeliggør følsomhedsbestemmelse af Mycoplasma spp.
English: Consequently the CVMP concluded that the indications 'bovine mastitis caused by Mycoplasma spp.'
Danish: CVMP konkluderede følgelig, at indikationerne "bovin mastitis forårsaget af Mycoplasma spp."
English: infected dairy cows and directly plated on mycoplasma agar to evaluate shedding patterns.
Danish: Prøverne blev podet direkte på mycoplasma-agar for at vurdere udskillelsesmønstret.
English: Cattle Calves Sheep Goats Pigs Dogs
Danish: Kvæg Får Geder Svin
English: Provided that the indications 'bovine mastitis caused by Mycoplasma spp.'
Danish: Forudsat at indikationerne "bovin mastitis forårsaget af Mycoplasma spp."
English: with tylosin delays the correct diagnosis, impedes efficient control measures and enables the spread of the pathogen thus risking animal health and welfare, causing severe economic loss and increasing the risk of antimicrobial resistance due to increased need for antimicrobial treatment.
Danish: forsinker korrekt diagnose, hindrer effektive kontrolforanstaltninger og giver mulighed for spredning af den patogene organisme, hvilket sætter dyrs sundhed og velfærd på spil, medfører alvorlige økonomiske tab og øger risikoen for antimikrobiel resistens som følge af øget behov for antimikrobiel behandling.
English: Inefficient treatment of mastitis caused by Mycoplasma spp.
Danish: Ineffektiv behandling med tylosin af mastitis forårsaget af Mycoplasma
English: with tylosin delays the correct diagnosis, impedes efficient control measures and enables the spread of the pathogen to other animals of the herd thus risking animal health and welfare along with increasing the need for antimicrobial treatment and development of antimicrobial resistance.
Danish: forsinker korrekt diagnose, hindrer effektive kontrolforanstaltninger, giver mulighed for spredning af den patogene organisme til andre dyr i besætningen med deraf følgende risiko for dyrenes sundhed og velfærd, øger behovet for antimikrobiel behandling og øger udviklingen af antimikrobiel resistens.
English: Slovak Republic Vétoquinol s.r.o.
Danish: Vétoquinol s.r.o.
English: Slovak Republic Biovet JSC 39 Petar Rakov Str.
Danish: Grækenland Biovet JSC 39 Petar Rakov Str.
English: Belgium Cross Vetpharma Group Ltd Broomhill Road, Tallagh Dublin 24
Danish: Cross Vetpharma Group Ltd Broomhill Road, Tallagh Dublin 24
English: United Kingdom Cross Vetpharm Group Ltd. Broomhill Road, Tallaght Dublin 24
Danish: Rumænien Cross Vetpharm Group Ltd. Broomhill Road, Tallaght Dublin 24
English: Grounds for amendment of the summary of product characteristics, labelling and package leaflet
Danish: Begrundelse for ændringen af produktresuméet, etiketteringen og indlægssedlen ud fra følgende betragtninger:
English: Delete, where applicable, any references to ‘bovine mastitis caused by Mycoplasma spp.
Danish: Slet enhver specifik doseringsangivelse vedrørende "bovin mastitis forårsaget af Mycoplasma spp.
English: The Committee considered that all references to indications ‘bovine mastitis caused by Mycoplasma spp.'
Danish: Foranstaltninger til risikohåndtering eller -begrænsning Udvalget fandt, at al omtale af indikationerne "bovin mastitis forårsaget af Mycoplasma spp."
English: Animal species
Danish: Kvæg får
English: 10 April 2014 (DLP:22 January 2012)
Danish: Den 10. april 2014 (skæringstidspunkt: 22. januar 2012)
English: Outline of the education materials within 3 months after the EC decision
Danish: Skitse til informationsmateriale senest tre måneder efter Kommissionens afgørelse
English: Conditions to the marketing authorisations
Danish: Betingelser for markedsføringstilladelsen
English: This will be included in the risk management plan, highlighting the risks, warnings and monitoring of hepatotoxicity
Danish: Dette skal indgå i risikostyringsplanen og skal fremhæve risici, advarsler og overvågning i forbindelse med hepatotoksicitet
English: National competent authorities of Member State(s) or reference Member State(s) if applicable, shall ensure that the following conditions are fulfilled by the MAH(s):
Danish: De nationale kompetente myndigheder i medlemsstaterne eller i givet fald i referencemedlemsstaten sikrer, at indehaverne af markedsføringstilladelse opfylder følgende vilkår:
English: The MAH(s) should provide within the risk management plan submission, a protocol for the drug utilisation study to characterise prescribing practices for the medicinal product during typical clinical use in representative groups of prescribers and to assess main reasons for prescription.
Danish: Som en del af risikostyringsplanen forelægger indehaveren af markedsføringstilladelsen en protokol til en undersøgelse af lægemiddelanvendelse, hvis formål er at karakterisere typisk ordinationspraksis for lægemidlet hos repræsentative grupper af ordinerende læger og fastlægge hovedgrundene til ordination.
English: The MAH(s) should provide within the risk management plan Educational material for prescribers and patients.
Danish: Indehaverne af markedsføringstilladelse forelægger sammen med risikostyringsplanen et sæt informationsmateriale til ordinerende læger og patienter.
English: The MAH(s) should submit the core elements (including outline of DUS, PASS and educational materials) of a risk management plan in EU format.
Danish: Indehaverne af markedsføringstilladelse forelægger kerneelementerne til en risikostyringsplan i EU-format (herunder skitse til undersøgelse af lægemiddelanvendelse, sikkerhedsundersøgelse efter godkendelse (PASS) samt informationsmateriale).
English: The MAH(s) should submit the next yearly PSUR by:
Danish: Indehaverne af markedsføringstilladelse indsender den næste periodiske opdaterede sikkerhedsindberetning senest:
English: See comments above.
Danish: Se kommentarerne ovenfor.
English: Round down to the nearest whole number.
Danish: Rundet ned til nærmeste hele tal.
English: ** This amount may also cause harm to the unborn child.
Danish: ** Denne mængde kan også forårsage skade på det ufødte barn.
English: (See appendix)
Danish: (Se bilag)
English: Topical, parenteral Zero
Danish: Topikal, Parenteral Nul
English: Safety limit
Danish: Sikkerhedsgrænse
English: Volumes of beer and wine (A and B) should be rounded up to the next whole number.
Danish: Øl- og vinmængder (A og B) skal rundes op til næste hele tal.
English: Medical monitoring is required.
Danish: Monitorering er påkrævet.
English: Not a typical excipient, but a warning is considered necessary.
Danish: Dette er ikke et typisk hjælpestof, men en advarsel anses for at være nødvendig.
English: See Q&A document (EMA/CHMP/619104/2013) for further calculations.
Danish: Se Q&A dokument (EMA/CHMP/619104/2013) for yderligere beregninger.
English: Increased risk due to accumulation in young children.
Danish: Øget risiko som følge af akkumulering hos små børn.
English: May be harmful to the teeth.
Danish: Kan være skadeligt for tænderne.
English: CAS No
Danish: CAS Nr.
English: Do not use this medicine in children less than 5 years old.
Danish: Brug ikke dette lægemiddel til børn under 5 år.
English: There is insufficient information on the effects of CDs in children < 2 years old.
Danish: Der er utilstrækkelig information omkring virkningen af CD'er hos småbørn <2 år.
English: It may also affect their ability to concentrate and take part in physical activities.
Danish: Det kan også påvirke deres koncentrationsevne og evnen til at tage del i fysiske aktiviteter.
English: < 12 years
Danish: < 12 år
English: Appendix: European Union list of fragrance allergens requiring labelling on cosmetic and detergent products
Danish: Bilag: Den Europæiske Unions liste over parfumeallergener, der kræver mærkning efter regler for kosmetiske og vaske- og rengøringsmiddelprodukter
English: This is because it may affect your judgement and how fast you react.
Danish: Det skyldes, at det kan påvirke din dømmekraft og reaktionshastighed.
English: Patients should be monitored in case of prolonged use.
Danish: Patienter bør monitoreres under langvarig anvendelse.
English: Therefore, a case by case judgement should be made regarding the risk/benefit for the patient.
Danish: Derfor skal der foretages en vurdering fra sag til sag om fordele/ulemper for patienten.
English: May cause non-immunologic immediate contact reactions by a possible cholinergic mechanism.
Danish: Kan forårsage ikke-immunologiske kontaktreaktioner ved en mulig cholinerg mekanisme.
English: < 2 years
Danish: < 2 år
English: Where relevant, the interactions of ethanol should be stated in the SmPC (section 4.5).
Danish: Hvor det er relevant, skal ethanols interaktioner angives i SPC´et (punkt 4.5).
English: See EMEA Public Statement, 8 July 1999, Ref. EMEA/20962/99
Danish: Se EMEA Public Statement, 8 July 1999, Ref. EMEA/20962/99
English: Based on animal studies and human experience, harmful effects of CDs are not to be expected at doses below 20 mg/kg/day.
Danish: Baseret på dyreforsøg og erfaring hos mennesker, forventes skadelige virkninger ikke af CD'er ved doser under 20 mg/kg/døgn.
English: Safety aspects of CDs have been considered during the development and safety assessment of the drug product, and are clearly stated in the SmPC.
Danish: Sikkerhedsaspekter af CD'er er blevet overvejet under udviklings- og sikkerhedsvurderingen af lægemidlet og er tydeligt angivet i produktresuméet.
English: Intravenous (IV) 30 mmol/l
Danish: Intravenøs (IV) 30 mmol/l
English: *< >: fragrance allergens listed in appendix.
Danish: *< >: duftallergener er listet i bilag.
English: These effects may include feeling sleepy and changes in behaviour.
Danish: Disse påvirkninger kan omfatte søvnighed og adfærdsændringer.
English: [* The statement 'gluten-free' applies only if the gluten content in the medicinal product is less than 20 ppm.]
Danish: [* Angivelsen »glutenfri« gælder kun hvis glutenindholdet i lægemidlet er mindre end 20 ppm.]
English: May cause pain at the site of injection.
Danish: Kan give smerter på injektionsstedet.
English: Absorption through the immature skin of neonates is significant.
Danish: Absorption gennem nyfødtes umodne hud er væsentlig.
English: This is also relevant for children, where the maximum daily intake is considered to be proportional to adults and based on energy requirements.
Danish: Dette gælder også for børn, hvor den maksimale daglige indtagelse anses som proportional med den maksimale daglige indtagelse for voksne og baseret på energibehov.
English: 3 mg B/day < 18 years** 7 mg B/day ≥ 18 years** 10 mg B/day
Danish: 3 mg B/døgn < 18 år** 7 mg B/døgn ≥ 18 år** 10 mg B/døgn
English: In addition to allergic reactions in sensitised patients, nonsensitised patients may become sensitised.
Danish: Foruden allergiske reaktioner hos sensibiliserede patienter, kan non-sensibiliserede patienter blive sensibiliserede.
English: SmPC: contraindication.
Danish: Produktresumé: Kontraindikation.
English: The corresponding warning in the SmPC/PL should be added if appropriate.
Danish: En tilsvarende advarsel i SPC/PIL skal tilføjes, hvis det er relevant.
English: Depending on the product and concentration of ethanol, the warning “flammable” may be necessary.
Danish: Afhængig af produktet og koncentrationen af alkohol, kan advarslen ”brandfarlig” være nødvendig.
English: The minimum amount of benzyl alcohol at which toxicity may occur is not known.
Danish: Den mindste mængde benzylalkohol, hvor der kan forekomme toksicitet, er ikke kendt.
English: May increase sensitivity to UV light (natural and artificial sunlight).
Danish: Kan øge følsomheden over for ultraviolet lys (både naturligt og kunstigt sollys).
English: As a consequence, administration of propylene glycol to pregnant or lactating patients should be considered on a case by case basis.
Danish: Som følge heraf bør administration af propylenglycol til gravide eller ammende kvinder overvejes fra sag til sag.
English: Neither non-clinical nor clinical data are available to assess aspartame use in infants below 12 weeks of age.
Danish: Hverken non-kliniske eller kliniske data er tilgængelige til vurdering af anvendelse af aspartam hos spædbørn under 12 uger.
English: In such cases the package leaflet and SmPC should include a statement such as: Because this medicine is usually given slowly over XX hours, the effects of alcohol may be reduced.
Danish: I sådanne tilfælde skal SPC og indlægsseddel indeholde et udsagn såsom: Da dette lægemiddel sædvanligvis indgives langsomt over XX timer, kan alkoholens virkning være reduceret.
English: Oral products used frequently or over a long period of time, e.g. for two weeks or longer.
Danish: Orale produkter, der anvendes hyppigt eller over lang tid, f.eks. i to uger eller længere
English: From the limited data available, there is no difference in the adverse event profile in children compared to adults.
Danish: På baggrund af de begrænsede tilgængelige data er der ingen forskel i bivirkningsprofilen hos børn sammenlignet med voksne.
English: Heparin (as an excipient)
Danish: Heparin (som hjælpestof)
English: For SmPC wording please refer to PRAC recommendation: “1.3.
Danish: Produktresumé forslag, se PRAC anbefaling: “1.3.
English: EMA/CHMP/302620/2017/EN Rev. 1
Danish: EMA/CHMP/302620/2017/DA Rev. 1
English: Substance
Danish: Substans
English: Therefore doses higher than 500 mg/kg/day may be administered in children > 5 years old but will have to be considered case by case.
Danish: Derfor kan doser højere end 500 mg/kg/døgn indgives hos børn> 5 år, men skal overvejes enkeltvis.
English: It may cause burning sensation on damaged skin.
Danish: Det kan forårsage en brændende fornemmelse på skadet hud.
English: Amount of boron per age group which may impair fertility if exceeded:
Danish: Mængden af bor pr. aldersgruppe, der kan forringe frugtbarheden, hvis overskredet:
English: The content of sorbitol in medicinal products for oral use may affect the bioavailability of other medicinal products for oral use administered concomitantly.
Danish: Indholdet af sorbitol i lægemidler til oral brug kan påvirke biotilgængeligheden af andre lægemidler til oral brug hvis indgivet samtidig.
English: Benzyl alcohol is listed as one of the 26 fragrance allergens but can also be used as an excipient.
Danish: Benzylalkohol er opført som et af de 26 duftallergener, men kan også bruges som hjælpestof.
English: Coumarin d-Limonene
Danish: Coumarin d-Limonen
English: Sensitivity to SLS will also vary according the type of formulation (and effects of other excipients), the concentration of SLS, contact time and patient population (children, hydration level, skin color and disease).
Danish: Overfølsomhed over for SLS vil også variere afhængigt af formuleringen (og virkningerne af andre hjælpestoffer), koncentrationen af SLS, kontakttid og patientpopulation (børn, hydratiseringsniveau, hudfarve og sygdom).
English: [If the medicine is in contact with teeth (e.g. oral liquids, lozenges or chewable tablets) and is intended for long term use:] Fructose may damage teeth.
Danish: [Hvis lægemidlet er i kontakt med tænderne (f.eks. orale væsker, sugetabletter eller tyggetabletter) og er beregnet til langvarig brug:] Fructose kan skade tænderne.
English: Your doctor may carry out extra checks while you are taking this medicine.
Danish: Din læge kan udføre ekstra kontrol, mens du tager/får dette lægemiddel.
English: Latex Natural Rubber (latex)
Danish: Latex Naturgummi (latex)
English: Suggestion for information in the SmPC:
Danish: Forslag til information i SPC´et:
English: The thickness of the skin varies considerably according to the body site and with age and can be an important factor in the sensitivity to sodium laurilsulfate (SLS).
Danish: Tykkelsen af huden varierer betydeligt i forhold til kropsstedet og med alderen, og kan være en vigtig faktor i overfølsomheden over for natriumlaurilsulfat (SLS).
English: Use during pregnancy and lactation is not expected to be associated with harmful effects to the mother as cutaneous absorption of benzalkonium chloride is minimal.
Danish: Anvendelse under graviditet og amning forventes ikke at medføre problemer for moderen, idet kutan absorption af benzalkoniumchlorid er minimal.
English: 200 mg/kg/day and use for > 2 weeks
Danish: 20mg/kg/døgn og anvendelse for > 2 uger
English: Additional statement to be mentioned for vaccines.
Danish: Denne advarsel gælder for vacciner.
English: Should be used with caution in dry eye patients and in patients where the cornea may be compromised.
Danish: Skal anvendes med forsigtighed hos patienter med tørre øjne og hos patienter, hvor hornhinden kan være kompromitteret.
English: You should not apply this medicine to the breasts if you are breast‑feeding because the baby may take it in with your milk.
Danish: Du bør ikke anvende dette lægemiddel på brysterne, hvis du ammer, fordi barnet kan indtage det med mælken.
English: Tell your doctor if <you/your child> have/has any known allergies.
Danish: Fortæl lægen, hvis du/dit barn har nogen kendte allergier.
English: Various adverse events, such as hyperosmolality, lactic acidosis; renal dysfunction (acute tubular necrosis), acute renal failure; cardiotoxicity (arrhythmia, hypotension); central nervous system disorders (depression, coma, seizures); respiratory depression, dyspnoea; liver dysfunction; haemolytic reaction (intravascular haemolysis) and haemoglobinuria; or multisystem organ dysfunction, have been reported with high doses or prolonged use of propylene glycol.
Danish: Forskellige bivirkninger, såsom hyperosmolalitet, lactacidosis; nedsat nyrefunktion (akut tubulær nekrose), akut nyresvigt; kardiotoksicitet (arytmi, hypotension); lidelser i centralnervesystemet (depression, koma, anfald); respirationsdepression, dyspnø; leverdysfunktion; hæmolytisk reaktion (intravaskulær hæmolyse) og hæmoglobinuri eller generelt nedsat funktion af organer, er rapporteret ved høje doser eller langvarig brug af propylenglycol.
English: May be irritant to the skin.
Danish: Kan virke irriterende på huden.
English: This is equivalent to y% of the recommended maximum daily dietary intake of sodium for an adult.
Danish: Dette svarer til y% af den anbefalede maximale daglige indtagelse af natrium for en voksen.
English: One of the major hydrolysis products is phenylalanine.
Danish: Et af de primære nedbrydningsprodukter er phenylalanin.
English: <Benzoic acid/Benzoate salt> may increase jaundice (yellowing of the skin and eyes) in newborn babies (up to 4 weeks old).
Danish: <Benzoesyre/benzoat> kan øge gulsot (gulning af huden og øjnene) hos nyfødte (op til 4 uger).
English: A dose of (select maximum dose) of this medicine administered to (a child A years of age and weighing B kg or an adult weighing 70 kg) would result in exposure to C mg/kg of ethanol which may cause a rise in blood alcohol concentration (BAC) of about D mg/100 ml (see Appendix 1 of report EMA/CHMP/43486/2018).
Danish: En dosis på (vælg maksimal dosis) af dette lægemiddel givet til (et barn i alderen A, der vejer B kg eller en voksen, der vejer 70 kg) resulterer i en eksponering for ethanol på C mg/kg, hvilket kan forårsage en stigning i koncentrationen af ethanol i blodet på ca. D mg/100 ml (se rapporten EMA/CHMP/43486/2018, bilag 1).
English: Increase in bilirubinaemia following its displacement from albumin may increase neonatal jaundice which may develop into kernicterus (non-conjugated bilirubin deposits in the brain tissue).
Danish: Forøgelse af bilirubinæmi efter dets forskydning fra albumin kan øge neonatal gulsot, der kan udvikle sig til kernicterus (ukonjugerede bilirubinaflejringer i hjernevæv).
English: Benzalkonium chloride may be absorbed by soft contact lenses and may change the colour of the contact lenses.
Danish: Benzalkoniumchlorid kan absorberes af bløde kontaktlinser og kan ændre farven af kontaktlinserne.
English: Do not give to your newborn baby (up to 4 weeks old), unless recommended by your doctor.
Danish: Giv ikke til dit nyfødte barn (op til 4 uger), medmindre det anbefales af din læge.
English: One <dosage unit> contains no more than x micrograms of gluten.
Danish: Én <dosisenhed> indeholder ikke mere end x mikrogram gluten.
English: The name of the excipient on the packaging should be: 'Wheat starch'.
Danish: Hjælpestoffets navn på mærkningen bør være: »hvedestivelse«.
English: In neonates (pre-term and term newborn infants), high concentrations of ethanol may cause severe local reactions and systemic toxicity due to significant absorption through immature skin (especially under occlusion).
Danish: Hos nyfødte (for tidligt fødte og fuldbårne spædbørn), kan høje koncentrationer af ethanol medføre alvorlige lokale reaktioner og systemisk toksisitet på grund af en signifikant absorption gennem huden (især ved bandagering).
English: Talk to your doctor or pharmacist if you need <Z> or more <dosage units> daily for a prolonged period, especially if you have been advised to follow a low salt (sodium) diet.
Danish: Tal med din læge eller apotekspersonalet, hvis du skal tage <Z> eller flere <dosisenheder> dagligt i længere tid, især hvis du er blevet rådet til at følge en diæt med lav salt (natrium) indhold.
English: * 1 mg B (Boron) = 5.7 mg boric acid.
Danish: * 1 mg B (Bor) = 5.7 mg borsyre.
English: Patient populations with decreased skin barrier functions such as in atopic dermatitis are more sensitive to the irritant properties of SLS.
Danish: Patienter med nedsatte hudbarrierefunktioner som i atopisk dermatitis er mere følsomme over for SLS's irriterende egenskaber.
English: 1 mg B/day
Danish: 1 mg B/døgn
English: At high doses cyclodextrins can cause reversible diarrhoea and cecal enlargement in animals.
Danish: Ved høje doser, kan cyclodextriner forårsage reversibel diarré og cecal forstørrelse hos dyr.
English: 1 mmol of sodium (Na) = 23 mg Na = 58.4 mg salt (NaCl).
Danish: 1 mmol natrium (Na+) = 23 mg Na+ = 58.4 mg salt (NaCl).
English: Warning in section 4.4 in the SmPC should be given if used in neonates.
Danish: Der bør være en advarsel i afsnit 4.4 i produktresuméet, hvis det anvendes hos nyfødte.
English: In children less than 2 years, the lower glomerular function may protect against renal toxicity, but can lead to higher blood levels of cyclodextrins.
Danish: Hos småbørn under 2 år, kan den lavere glomerulære funktion beskytte mod nyretoksicitet, men kan føre til højere blodniveauer af cyclodextriner.
English: Soya oil Hydrogenated soya oil
Danish: Sojaolie Hydrogeneret sojaolie
English: Cyclodextrins (CDs) are excipients which can influence the properties (such as toxicity or skin penetration) of the active substance and other medicines.
Danish: Cyclodextriner (CD'er) er hjælpestoffer, som kan påvirke egenskaberne (såsom toksicitet eller hudgennemtrængning) af aktive stoffer og andre lægemidler.
English: Phosphate buffers
Danish: Phosphat buffer