FrancophonIA/ELRC3.0 huggingface dataset:
English: SPECIAL STORAGE CONDITIONS Store below 25 C.
Danish: Opbevares under 25°C.
English: Based on the worst-case scenario where all quarters were treated according to the recommended posology, the withholding time of 84 hours or 7 milkings as claimed by the marketing authorisation holders was considered acceptable.
Danish: Baseret på det værst tænkelige scenarie, hvor alle områder blev behandlet i henhold til den anbefalede dosering, blev den af indehaverne af markedsføringstilladelsen anførte tilbageholdelsestid på 84 timer eller 7 malkninger betragtet som acceptabel.
English: Intramammary administration of prednisolone seems not affect the functions of neutrophils.
Danish: Intramammær administration af prednisolon ser ikke ud til at påvirke neutrofilers funktion.
English: Slovenia PFIZER Luxembourg SARL
Danish: Slovenien PFIZER Luxembourg SARL
English: Amoxicillin was the limiting active substance to determine the withdrawal period in milk.
Danish: Amoxicillin var det begrænsende aktive stof ved bedømmelse af tilbageholdelsesperioden i mælk.
English: Intramammary suspension
Danish: Intramammær suspension
English: 23/25 Avenue Du Docteur Lannelongue 75014 Paris France
Danish: Frankrig PFIZER 23/25 Avenue Du Docteur Lannelongue 75014 Paris Frankrig
English: Synulox Lactating Cow was non-inferior to the comparator.
Danish: Synulox Lactating Cow var ikke ringere end sammenligningsproduktet.
English: For a full list of excipients see section 6.1.
Danish: Se afsnit 6.1 for en fuldstændig fortegnelse over hjælpestoffer.
English: Globally, the in vitro susceptibility of most mastitis pathogens was very high.
Danish: Overordnet set var de fleste mastitispatogeners modtagelighed in vitro meget høj.
English: In combination with SYNULOX RTU:
Danish: I kombination med SYNULOX RTU:
English: Before the infusion is made, the teat end should be cleaned and disinfected.
Danish: Før infusionen udføres, skal pattespidsen renses og desinficeres.
English: Therefore overall treatment length must be at the veterinarian's discretion but should be long enough to ensure complete resolution of intramammary infection.
Danish: Den totale behandlingsvarighed vil være dyrlægens skøn, men skal være lang nok til at sikre fuldstændig ophævelse af den intramammære infektion.
English: Pfizer Ltd Ramsgate Road Sandwich Kent CT13 9NJ United Kingdom
Danish: Pfizer Ltd Ramsgate Road Sandwich Kent CT13 9NJ Storbritannien
English: Therefore, while clinical cure and bacteriological cure have been demonstrated for the formulation it was considered that the marketing authorisation holders had not demonstrated the efficacy of prednisolone in the combination.
Danish: Selvom der er påvist klinisk og bakteriologisk helbredelse med formuleringen, var CVMP derfor af den opfattelse, at indehaverne af markedsføringstilladelsen ikke havde påvist virkningen af prednisolon i kombinationen.
English: Avoid use of the product in herds where no β-lactamase producing Staphylococci strains have been isolated.
Danish: Undgå anvendelsen af produktet i besætninger, hvor der ikke er isoleret β-lactamaseproducerende stammer af Staphylococci.
English: Pharmacological properties: “Prednisolone is a glucocorticoid with anti-inflammatory properties.
Danish: Farmakologiske oplysninger: ”Prednisolon er et glucokortikoid med antiinflammatoriske egenskaber.
English: Clavulanic acid is a valuable addition to amoxicillin for efficacy against mastitis pathogens and caused the MIC of target pathogens to amoxicillin only to be greatly reduced.
Danish: Clavulansyre er en vigtig tilføjelse til amoxicillin for at opnå effekt mod mastitispatogener og forårsagede, at kun MIC af målpatogener over for amoxicillin blev kraftigt reduceret.
English: Veterinarians should strive to use narrow spectrum antibiotics if possible.
Danish: Dyrlæger bør om muligt søge at anvende smalspektret antibiotika.
English: Withdrawal period (meat and milk)
Danish: Lægemiddelform Dyreart Tilbageholdelsestid (kød og mælk)
English: Europa 20-B Parque Empresarial La Moraleja 28108 Alcobendas (Madrid)
Danish: Europa 20-B Parque Empresarial La Moraleja
English: Use of the product should be based on local (regional, farm level) epidemiological information about susceptibility of the target bacteria and take into account official and local antimicrobial policies.
Danish: Anvendelse af lægemidlet bør baseres på lokal (regional, gårdniveau) epidemiologisk information om målbakteriernes modtagelighed og tage hensyn til officielle og lokale antimikrobielle politikker.
English: • Indications;
Danish: • Indikationer
English: Amoxicillin is a broad spectrum bactericidal -lactam antibiotic.
Danish: Amoxicillin er et bredspektret baktericidt -lactam-antibiotikum.
English: Pharmacokinetic studies, performed with the finished product revealed individual concentrations of amoxicillin in milk above the MIC90 (2 µg/ml) for Staphylococcus aureus until 12 hours after the last infusion.
Danish: Farmakokinetiske undersøgelser med det færdige lægemiddel viste individuelle koncentrationer af amoxicillin i mælk over MIC90 (2 µg/ml) for Staphylococcus aureus indtil 12 timer efter den sidste infusion.
English: Milk: 84 hours, i.e. 7 milking times with 2 times a day milking or 11 milking times with 3 times a day milking.
Danish: Mælk: 84 timer, dvs. 7 malkninger ved malkning 2 gange dagligt eller 11 malkninger ved malkning 3 gange dagligt.
English: The main sections of disharmony of the existing SPCs related to:
Danish: De punkter, der især er uenighed om i de eksisterende produktresuméer, er:
English: Milk: 60 hours In combination with SYNULOX RTU:
Danish: Mælk: 60 timer I kombination med SYNULOX RTU:
English: Synulox Lactating Cow was shown to be efficacious regarding the main mastitis pathogens: Staphylococci, Streptococci and Escherichia coli.
Danish: Synulox Lactating Cow viste sig at være effektivt med hensyn til de vigtigste mastitispatogener: stafylokokker, streptokokker og Escherichia coli.
English: The comparator product was authorised for similar indications (Staphylococci, Streptococci, Escherichia coli), but has a different composition (penethamate, dihydrostreptomycin, framycetin and prednisolone) and a different interval of administration (24 hours for the comparator instead of 12
Danish: Sammenligningslægemidlet var godkendt til de samme indikationer (stafylokokker, streptokokker, Escherichia coli), men har en anden sammensætning (penethamat, dihydrostreptomycin, framycetin og prednisolon) og et andet administrationsinterval (24 timer for sammenligningslægemidlet i stedet for 12 timer for Synulox Lactating Cow).
English: Milk: 14 days.
Danish: Mælk: 14 dage.
English: While the clinical added value of prednisolone in Synulox Lactating Cow remains questionable, no risk arising from its use has been identified from clinical trials and pharmacovigilance.
Danish: Mens den kliniske merværdi af prednisolon i Synulox Lactating Cow er tvivlsom, er der ikke i kliniske undersøgelser og lægemiddelovervågning identificeret nogen risiko ved brug af prednisolon.
English: Milk: 2 days
Danish: Mælk: 2 dage
English: Prednisolone
Danish: Prednisolon
English: The combination of amoxicillin and clavulanic acid has a broad spectrum antimicrobial activity including -lactamase producing organisms.
Danish: Kombinationen af amoxicillin og clavulansyre har en bredspektret antimikrobiel aktivitet, herunder lactamaseproducerende organismer.
English: Milk samples were collected from each animal immediately before the administration of the test product, then for the following 16 milkings, starting 12 hours after the last treatment.
Danish: Der blev taget mælkeprøver af alle dyr umiddelbart før indgivelse af testlægemidlet og derefter i 16 efterfølgende malkninger med start 12 timer efter den sidste behandling.
English: The review of literature on the current level of resistance to amoxycillin/clavulanic acid among clinically significant mastitis pathogens indicates that resistance remains low.
Danish: Gennemgang af litteratur om klinisk signifikante mastitispatogeners aktuelle resistensniveau over for amoxycillin/clavulansyre viser, at resistensen er lav.
English: Do not store above 25°C.
Danish: Må ikke opbevares ved temperaturer over 25
English: • the CVMP considered the primary scope of the referral regarding the efficacy of the product for the treatment of bovine mastitis in lactating cows and the added value of the prednisolone in the product;
Danish: • CVMP tog højde for indbringelsesprocedurens primære anvendelsesområde vedrørende virkningen af lægemidlet til behandling af bovin mastitis hos diegivende malkekøer og den merværdi, prednisolon giver lægemidlet;
English: With cows milked twice daily, milk for human consumption may only be taken the 7th milking after the last treatment.
Danish: For køer, der malkes 2 gange dagligt, må mælk bestemt til menneskeføde først udtages ved 7. malkning efter sidste behandling.
English: Consequently the CVMP considered that since the added value of prednisolone in the product has not been demonstrated, the following statement in the SPC under section 5.
Danish: CVMP var således af den opfattelse, at da merværdien af prednisolon i lægemidlet ikke var påvist, skulle følgende sætning i produktresuméet under pkt.
English: 1. to assess if efficacy of Synulox Lactating Cow and associated names has been demonstrated for bovine mastitis in lactating cows,
Danish: 1. at bedømme, om der er påvist virkning af Synulox Lactating Cow og relaterede navne ved bovin mastitis hos diegivende køer,
English: Analytical determinations of the marker residues were carried out by high-performance liquid chromatography.
Danish: Analytiske bestemmelser af restmarkører blev gennemført med væskekromatografi med høj kapacitet.
English: 2. if efficacy is confirmed, to assess if efficacy of amoxicilline/clavulanic acid/prednisolone combination is superior to treatment with amoxicilline/clavulanic acid alone, 3. to consider whether the benefit/risk balance of this product is positive and, if not, whether the marketing authorisations should be (i) amended, (ii) revoked or (iii) suspended on grounds of safety and efficacy.
Danish: 3. at bedømme, om lægemidlets risk/benefit-forhold er positivt og, hvis ikke, om markedsføringstilladelserne bør (i) ændres, (ii) tilbagekaldes eller (iii) suspenderes på grund af sikkerhed og virkning.
English: In a Staphylococcus aureus challenge, a reduction of udder induration, udder swelling and inflammation was observed at some time-points following the product administration.
Danish: I en Staphylococcus aureus-eksponering sås en reduktion af induration, hævelse af yveret og inflammation på nogle tidspunkter efter administration af lægemidlet.
English: Added value of prednisolone in the combination The current SPC indicates that prednisolone has an anti-inflammatory action which helps to reduce the potentially destructive swelling and inflammation associated with mastitis, without affecting the white cell response to infection.
Danish: Det aktuelle produktresumé angiver, at prednisolon har en antiinflammatorisk virkning, som hjælper med at reducere den potentielt destruktive hævelse og inflammation, som er forbundet med mastitis, uden at påvirke de hvide blodlegemers respons på infektionen.
English: Milk: 72 Hours
Danish: Mælk: 72 timer
English: STATEMENT OF ACTIVE AND OTHER SUBSTANCES One syringe (3 g) contains:
Danish: Aktive indholdsstoffer: 1 sprøjte (3 g) indeholder:
English: Do not use in animals, which are known to be hypersensitive to ß-lactam antibiotics.
Danish: Må ikke anvendes til dyr med kendt overfølsomhed over for -lactam-antibiotika.
English: To be supplied only on veterinary prescription.
Danish: Kun til dyr - må kun udleveres efter veterinærrecept.
English: The tissue samples were analysed for amoxicillin, clavulanic acid and prednisolone by the validated HPLC method.
Danish: Vævsprøver blev analyseret for amoxicillin, clavulansyre og prednisolon med den validerede HPLC-metode.
English: Ireland Pfizer Healthcare Ireland, Trading as Pfizer Animal Health Ringaskiddy
Danish: Pfizer Healthcare Ireland, Trading as Pfizer Animal Health Ringaskiddy County Cork Irland
English: The withdrawal period was supported by a residue depletion study where 20 cows received an infusion of one injector per quarter of Synulox Lactating Cow in all 4 quarters of the udder at 12-hour intervals following 3 consecutive milkings.
Danish: Tilbageholdelsesperioden blev understøttet af en restkoncentrationsundersøgelse, hvor 20 køer fik en infusion med en injektion pr. område med Synulox Lactating Cow i alle yverets fire områder med 12 timers intervaller efter tre malkninger i træk.
English: • The efficacy of the product for the treatment of clinical mastitis in lactating dairy cows was compared with another veterinary medicinal product authorised in the United Kingdom.
Danish: • Virkningen af lægemidlet til behandling af klinisk mastitis hos diegivende malkekøer blev sammenlignet med et andet veterinærlægemiddel, som er godkendt i Det Forenede Kongerige.
English: Emulsifying Wax White Soft Paraffin Liquid Paraffin Light
Danish: Emulgerende voks Hvid blød paraffin Tynd paraffinolie
English: In the second study 20 healthy lactating dairy cows were treated 3 times, by the intramammary route, with the test product at the dosage of 1 syringe infused into each quarter via the teat canal, immediately after milking, for 3 consecutive milkings.
Danish: I den anden undersøgelse blev 20 raske, diegivende malkekøer behandlet 3 gange intramammært med testlægemidlet i doser på 1 sprøjte infunderet i hvert område via pattekanalen umiddelbart efter malkningen ved 3 malkninger i træk.
English: Considering that no product specific data have been provided in support of efficacy of an extended duration of treatment, the following recommendation has been included into the SPC under section 4.9 Amounts to be administered and administration route:
Danish: I betragtning af at der ikke er fremlagt nogen produktspecifikke data, som understøtter virkningen af længere tids behandling, er følgende anbefaling tilføjet produktresuméet under pkt.
English: • In another study the efficacy of Synulox Lactating Cow for the treatment of clinical mastitis in the lactating dairy cow was compared with another veterinary medicinal product authorised in France.
Danish: • I en anden undersøgelse blev virkningen af Synulox Lactating Cow til behandling af klinisk mastitis hos diegivende malkekøer sammenlignet med et andet veterinærlægemiddel, som er godkendt i Frankrig.
English: The product should be used for treatment of clinical mastitis only.
Danish: Produktet må kun anvendes til behandling af klinisk mastitis.
English: The product is formulated for the treatment of bovine clinical mastitis in lactating cows.
Danish: Lægemidlet er formuleret til behandling af klinisk bovin mastitis hos diegivende køer.
English: Inappropriate use of the product may increase the prevalence of bacteria resistant to ß-lactam antibiotics and may decrease the effectiveness of treatment with ß-lactam antibiotics, due to the potential for crossresistance.
Danish: Uhensigtsmæssig anvendelse af produktet kan øge forekomsten af bakterier, der er resistente over for β-lactam-antibiotika og kan reducere virkningen af behandlingen med β-lactam-antibiotika på grund af muligheden for krydsresistens.
English: Cattle Meat: 7 days Milk: 60 hours In combination with SYNULOX RTU:
Danish: Kvæg Kød: 7 dage Mælk: 60 timer I kombination med SYNULOX RTU:
English: It is presented in disposable intramammary syringes containing 50 mg clavulanic acid as potassium clavulanate; 200 mg amoxicillin as amoxicillin trihydrate and 10 mg prednisolone in 3 g suspension.
Danish: Det findes i intramammære engangssprøjter med 50 mg clavulansyre som kaliumclavulanat, 200 mg amoxicillin som amoxicillintrihydrat, og 10 mg prednisolon i 3 g suspension.
English: In vitro clavulanic acid and amoxicillin in combination are active against a wide range of clinically important bacteria including the following organisms which are commonly associated with bovine mastitis:
Danish: In-vitro er kombinationen af clavulansyre og amoxicillin virksom over for et bredt spektrum af klinisk vigtige bakterier inklusive følgende mikroorganismer, der almindeligvis er associeret med bovin mastitis:
English: Penicillins and cephalosporins may cause hypersensitivity (allergy) following injection, inhalation, ingestion or skin contact.
Danish: Særlige forsigtighedsregler for personer, som indgiver lægemidlet til dyr Penicilliner og cephalosporiner kan medføre overfølsomhed (allergi) efter injektion, inhalation, indtagelse eller ved hudkontakt.
English: The product is presented in disposable intramammary syringes containing 200 mg amoxicillin as amoxicillin trihydrate, 50 mg clavulanic acid as potassium clavulanate and 10 mg prednisolone in 3 g suspension.
Danish: Lægemidlet fås som intramammære engangssprøjter med 200 mg amoxicillin som amoxicillintrihydrat, 50 mg clavulansyre som kaliumclavulanat og 10 mg prednisolon i 3 g suspension.
English: Calcium Sodium Aluminosilicate (dried) Mineral Oil (Formula A)
Danish: Calciumnatriumaluminiumsilicat (tørret) Mineralsk olie (formel A)
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Active substances:
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING
English: Milk: 80 hours.
Danish: Mælk: 80 timer.
English: Cattle Meat: 7 days Milk (cows milked twice daily): 60 hours (i.e. at the 5th milking) after the last treatment.
Danish: Kvæg Kød: 7 dage Mælk (køer malket 2 gange dagligt): 60 timer (d.v.s. ved 5. malkning) efter sidste behandling.
English: PACKAGE LEAFLET “Product name” (to be completed nationally) intramammary suspension for lactating cattle NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT Marketing authorisation holder: To be completed nationally
Danish: NAVN OG ADRESSE PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN SAMT PÅ DEN INDEHAVER AF VIRKSOMHEDSGODKENDELSE, SOM ER ANSVARLIG FOR BATCHFRIGIVELSE, HVIS FORSKELLIG HERFRA
English: The contents of one syringe should be infused into each affected quarter via the teat canal, immediately after milking, at 12 hour intervals for three consecutive milkings.
Danish: Indholdet af en sprøjte skal infunderes i hver af de berørte patter via pattekanalen umiddelbart efter malkning med 12 timers interval i 3 på hinanden følgende malkninger.
English: Therefore a positive clinical anti-inflammatory impact of prednisolone remains questionable.
Danish: Derfor er det stadig tvivlsomt, om prednisolon har en positiv, klinisk antiinflammatorisk virkning.
English: Clavulanic acid inactivates -lactamases.
Danish: Clavulansyre inaktiverer lactamaser.
English: Synulox Lactating Cow and associated names is a pale cream/buff coloured oily suspension containing clavulanic acid, amoxicillin and prednisolone in a base designed to disperse rapidly in milk.
Danish: Synulox Lactating Cow og relaterede navne er en lys cremefarvet/brungul oliesuspension, der indeholder clavulansyre, amoxicillin, og prednisolon i en base, som er designet til at opløses hurtigt i mælk.
English: Cattle (lactating cows).
Danish: Kvæg (diegivende køer).
English: Milk: 60 hours
Danish: Mælk: 60 timer
English: Synulox Lactating Cow and associated names is a pale cream/buff coloured oily suspension containing amoxicillin, clavulanic acid and prednisolone in a base designed to disperse rapidly in milk.
Danish: Synulox Lactating Cow og relaterede navne er en lys cremefarvet/brungul oliesuspension, der indeholder amoxicillin, clavulansyre og prednisolon i en base, som er udviklet til at opløses hurtigt i mælk.
English: OTHER INFORMATION To be completed nationally
Danish: Udfyldes nationalt
English: CONTENTS BY WEIGHT, BY VOLUME OR BY NUMBER OF DOSES One dose (3 g)
Danish: PAKNINGSSTØRRELSE ANGIVET SOM VÆGT, VOLUMEN ELLER ANTAL DOSER
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Polyethylene syringe
Danish: MINDSTEKRAV TIL OPLYSNINGER PÅ SMÅ INDRE PAKNINGER
English: DATE OF RENEWAL OF THE AUTHORISATION To be completed nationally
Danish: DATO FOR FØRSTE TILLADELSE/FORNYELSE AF TILLADELSEN
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER To be completed nationally
Danish: NAVN OG ADRESSE PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN
English: Milk: 60 hours.
Danish: Mælk: 60 timer.
English: The product is efficacious regarding the claimed indications, treatment of bovine clinical mastitis in lactating cows, including cases of infections associated with the following pathogens:
Danish: Lægemidlet er effektivt med hensyn til de påståede indikationer, behandling af klinisk bovin mastitis hos diegivende køer, herunder tilfælde med infektioner forbundet med følgende patogener:
English: However, it is recognised that in cases of infections caused by Staphylococcus aureus, a longer course of antibacterial therapy may be required.
Danish: Det er imidlertid anerkendt, at det ved tilfælde af infektioner forårsaget af Staphylococcus aureus kan være nødvendigt med antibakteriel behandling i længere tid.
English: In regard to public health risk, gastrointestinal bacteria are not significantly exposed to antimicrobial after this intramammary administration and milk is (nearly always) pasteurised prior to human consumption so the risk to human health from potential resistant pathogens after intramammary treatment is far lower than that which would arise following systemic use.
Danish: Med hensyn til risiko for folkesundheden er mave-tarmbakterier ikke signifikant eksponeret for antimikrober efter denne intramammære administration, og mælken er (næsten altid) pasteuriseret, før den indtages af mennesker.
English: Cattle Meat : 4 days Milk : 108 hours
Danish: Kvæg Kød: 4 dage Mælk: 108 timer
English: 6.6 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products, if appropriate
Danish: 6.6 Eventuelle særlige forholdsregler ved bortskaffelse af ubrugte veterinærlægemidler eller affaldsmaterialer fra brugen af sådanne
English: • the CVMP reviewed the summary of products characteristics, labelling and package leaflet proposed by the marketing authorisation holders and considered all the overall submitted data; the CVMP, concluded that the overall benefit/risk balance for this product remains positive subject to the recommended changes in the product information.
Danish: • CVMP vurderede produktresuméet, etiketteringen og indlægssedlen, som indehaverne af markedsføringstilladelsen havde foreslået, og tog alle de samlede indsendte data i betragtning;
English: Harmonisation of the posology
Danish: Harmonisering af dosering
English: Cattle Meat: 7 days Milk: 60 hours or 5 milking
Danish: Kvæg Kød: 7 dage Mælk: 60 timer eller 5 malkninger
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE Carton box
Danish: OPLYSNINGER, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE
English: “In cases of infections caused by Staphylococcus aureus, a longer course of antibacterial therapy may be required.
Danish: ”Ved tilfælde af infektioner forårsaget af Staphylococcus aureus kan det være nødvendigt med antibakteriel behandling i længere tid.
English: For use in clinical cases of mastitis including cases associated with infections with the following pathogens:
Danish: Til anvendelse ved kliniske tilfælde af mastitis inklusive tilfælde, der er associeret med infektioner med følgende patogener:
English: Escherichia coli (including -lactamase producing strains)
Danish: Escherichia coli (inklusive -lactamaseproducerende stammer)
English: MARKETING AUTHORISATION NUMBER(S) To be completed nationally
Danish: MARKEDSFØRINGSTILLADELSENS NUMMER (NUMRE)
English: In cases of infections caused by Staphylococcus aureus, a longer course of antibacterial therapy may be required.
Danish: I tilfælde af infektioner forårsaget af Staphylococcus aureus, kan en længerevarende antibakteriel behandlingscyklus være påkrævet.
English: Pale cream/buff coloured oily suspension.
Danish: Svagt gul/brungul olieagtig suspension.
English: Cattle Meat: 3 days Milk: 72 hours
Danish: Kvæg Kød: 3 dage Mælk: 72 timer