natgillin/translations-raw huggingface dataset:
EU/1/13/844/010 10 filmovertrukne tabletter EU/1/13/844/011 14 filmovertrukne tabletter EU/1/13/844/012 28 filmovertrukne tabletter EU/1/13/844/013 30 filmovertrukne tabletter EU/1/13/844/014 56 filmovertrukne tabletter EU/1/13/844/015 60 filmovertrukne tabletter EU/1/13/844/016 90 filmovertrukne tabletter EU/1/13/844/017 98 filmovertrukne tabletter EU/1/13/844/018 100 filmovertrukne tabletter EU/1/13/844/029 84 filmovertrukne tabletter
EU/1/13/844/010 10 film-coated tablets EU/1/13/844/011 14 film-coated tablets EU/1/13/844/012 28 film-coated tablets EU/1/13/844/013 30 film-coated tablets EU/1/13/844/014 56 film-coated tablets EU/1/13/844/015 60 film-coated tablets EU/1/13/844/016 90 film-coated tablets EU/1/13/844/017 98 film-coated tablets EU/1/13/844/018 100 film-coated tablets EU/1/13/844/029 84 film-coated tablets
Tegnene kan være udslæt, nældefeber, synke- eller vejrtrækningsbesvær, opsvulmede læber, ansigt, svælg eller tunge og besvimelsesfornemmelse.
The symptoms may include: a rash, hives, swallowing or breathing problems, swelling of your lips, face, throat or tongue and feeling faint.
Vipidia 25 mg filmovertrukne tabletter
Vipidia 25 mg film-coated tablets
Vipidia 12,5 mg filmovertrukne tabletter
Vipidia 12.5 mg film-coated tablets
EU/1/13/844/001 10 filmovertrukne tabletter EU/1/13/844/002 14 filmovertrukne tabletter EU/1/13/844/003 28 filmovertrukne tabletter EU/1/13/844/004 30 filmovertrukne tabletter EU/1/13/844/005 56 filmovertrukne tabletter EU/1/13/844/006 60 filmovertrukne tabletter EU/1/13/844/007 90 filmovertrukne tabletter EU/1/13/844/008 98 filmovertrukne tabletter EU/1/13/844/009 100 filmovertrukne tabletter EU/1/13/844/028 84 filmovertrukne tabletter
EU/1/13/844/001 10 film-coated tablets EU/1/13/844/002 14 film-coated tablets EU/1/13/844/003 28 film-coated tablets EU/1/13/844/004 30 film-coated tablets EU/1/13/844/005 56 film-coated tablets EU/1/13/844/006 60 film-coated tablets EU/1/13/844/007 90 film-coated tablets EU/1/13/844/008 98 film-coated tablets EU/1/13/844/009 100 film-coated tablets EU/1/13/844/028 84 film-coated tablets
En samlet analyse af data fra 13 studier viser, at den samlede forekomst af bivirkninger i form af alvorlige bivirkninger og bivirkninger, der førte til afbrydelse af behandlingen, var på samme niveau hos patienter, der fik enten 25 mg alogliptin, 12,5 mg alogliptin, aktiv kontrol eller placebo.
In a pooled analysis of the data from 13 studies, the overall incidences of adverse events, serious adverse events and adverse events resulting in discontinuation of therapy were comparable in patients treated with 25 mg alogliptin, 12.5 mg alogliptin, active control or placebo.
Alogliptin er ikke blevet undersøgt hos patienter i peritonealdialyse (se pkt.
Alogliptin has not been studied in patients undergoing peritoneal dialysis (see sections 4.2 and 5.2).
Brug sammen med andre antihyperglykæmiske lægemidler og i forbindelse med hypoglykæmi På grund af den forhøjede risiko for hypoglykæmi, når alogliptin tages sammen med sulfonylurinstof, insulin eller som kombinationsbehandling sammen med thiazolidindion og metformin, kan en lavere dosis af disse lægemidler overvejes for at reducere risikoen for hypoglykæmi (se pkt.
Due to the increased risk of hypoglycaemia in combination with a sulphonylurea, insulin or combination therapy with thiazolidinedione plus metformin, a lower dose of these medicinal products may be considered to reduce the risk of hypoglycaemia when these medicinal products are used in combination with alogliptin (see section 4.2).
Der er udført et fase II- og 13 fase III- (herunder det studie med kardiovaskulære endepunkter), dobbeltblindede, placebokontrollerede eller aktivt kontrollerede kliniske studier med deltagelse af i alt 14.779 patienter med type 2-diabetes mellitus, herunder 6.448 patienter, der blev behandlet med 25 mg alogliptin, og 2.476 patienter, der blev behandlet med 12,5 mg alogliptin, med henblik på at evaluere alogliptins effekt på glykæmisk kontrol samt lægemidlets sikkerhedsprofil.
A total of 14,779 patients with type 2 diabetes mellitus, including 6,448 patients treated with 25 mg alogliptin and 2,476 patients treated with 12.5 mg alogliptin, participated in one phase 2 or 13 phase 3 (including the cardiovascular outcomes study) double-blind, placebo- or active-controlled clinical studies conducted to evaluate the effects of alogliptin on glycaemic control and its safety.
En samlet analyse af fem 26-ugers placebokontrollerede studier viste, at virkningen af alogliptin hos patienter med type 2-diabetes mellitus under 65 år var den samme som hos patienter på 65 år og derover.
The efficacy of alogliptin in patients with type 2 diabetes mellitus and ≥ 65 years old across a pooled analysis of five 26-week placebo-controlled studies was consistent with that in patients < 65 years old.
Tegnene kan være rysten, svedtendens, angst, sløret syn, prikkende fornemmelse i læber, bleghed, humørsvingninger eller forvirring.
Symptoms may include: trembling, sweating, anxiety, blurred vision, tingling lips, paleness,
Vipidia 6,25 mg filmovertrukne tabletter
Vipidia 6.25 mg film-coated tablets
Vipidia gives i kombination med andre glucosesænkende lægemidler, herunder insulin, hvis disse sammen med diæt og motion ikke giver tilstrækkelig glykæmisk kontrol (se pkt.
Vipidia is indicated in adults aged 18 years and older with type 2 diabetes mellitus to improve glycaemic control in combination with other glucose lowering medicinal products including insulin, when these, together with diet and exercise, do not provide adequate glycaemic control (see sections 4.4, 4.5 and 5.1 for available data on different combinations).
Det er ikke nødvendigt at justere dosis af alogliptin hos patienter med let nedsat nyrefunktion (kreatininclearance (CrCl) > 50 til ≤ 80 ml/min), (se pkt.
For patients with mild renal impairment (creatinine clearance (CrCl) > 50 to ≤ 80 mL/min), no dose adjustment of alogliptin is necessary (see section 5.2).
Lever og galdeveje leverdysfunktion, herunder leversvigt ikke kendt
Hepatobiliary disorders hepatic dysfunction including hepatic failure not known
Hvis en patient får symptomer, der indikerer leverskader, skal der omgående udføres leverfunktionstest.
Obtain liver function tests promptly in patients with symptoms suggestive of liver injury.
Alogliptin 25 mg én gang dagligt sammen med et sulfonylurinstof (n = 197)
Alogliptin 25 mg once daily with a sulphonylurea (n=197)
ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver tablet indeholder 25 mg alogliptin (som benzoat).
STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 25 mg alogliptin (as benzoate).
ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver tablet indeholder 12,5 mg alogliptin (som benzoat).
STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 12.5 mg alogliptin (as benzoate).
Vipidia 12,5 mg filmovertrukne tabletter Hver tablet indeholder alogliptinbenzoat svarende til 12,5 mg alogliptin.
Vipidia 12.5 mg film-coated tablets Each tablet contains alogliptin benzoate equivalent to 12.5 mg alogliptin.
Tillæg af 25 mg alogliptin én gang dagligt til glyburidbehandling (gennemsnitlig dosis = 12,2 mg) resulterede i statistisk signifikante forbedringer i HbA1c fra baseline til uge 26, sammenholdt med placebo (tabel 2).
The addition of 25 mg alogliptin once daily to glyburide therapy (mean dose = 12.2 mg) resulted in statistically significant improvements from baseline in HbA1c at Week 26 when compared to the addition of placebo (Table 2).
Alogliptin som tillæg til insulin (med eller uden metformin) Tillæg af 25 mg alogliptin én gang dagligt til insulinbehandling (gennemsnitlig dosis = 56,5 IE, med eller uden metformin) resulterede i statistisk signifikante forbedringer af HbA1c og fasteplasmaglucose fra baseline til uge 26 sammenlignet med tillæg af placebo (tabel 2).
Alogliptin as add-on therapy to insulin (with or without metformin) The addition of 25 mg alogliptin once daily to insulin therapy (mean dose = 56.5 IU, with or without metformin) resulted in statistically significant improvements from baseline in HbA1c and fasting plasma glucose at Week 26 when compared to the addition of placebo (Table 2).
Behandling med 25 mg alogliptin én gang dagligt medførte statistisk signifikante forbedringer i HbA1c og fasteplasmaglucose fra baseline til uge 26 sammenholdt med placebogruppen (tabel 2).
Treatment with 25 mg alogliptin once daily resulted in statistically significant improvements from baseline in HbA1c and fasting plasma glucose compared to placebo-control at Week 26 (Table 2).
ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver tablet indeholder 6,25 mg alogliptin (som benzoat).
STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 6.25 mg alogliptin (as benzoate).
Den gennemsnitlige ændring i fasteplasmaglucose fra baseline til uge 52, ved administration af 25 mg alogliptin plus 30 mg pioglitazon plus metformin, var desuden signifikant større end den gennemsnitlige ændring, der blev registreret ved administration af 45 mg pioglitazon plus metformin (p < 0,001).
In addition, mean change from baseline in fasting plasma glucose at Week 52 for 25 mg alogliptin plus 30 mg pioglitazone and metformin was significantly greater than that for 45 mg pioglitazone and metformin (p<0.001).
- Vipidia 12,5 mg filmovertrukne tabletter (tabletter) er gule, ovale (ca. 9,1 mm lange og 5,1 mm brede), bikonvekse, filmovertrukne tabletter med "TAK" og "ALG-12.5" trykt i gråt på den ene side.
- Vipidia 12.5 mg film-coated tablets (tablets) are yellow, oval (approximately 9.1 mm long by 5.1 mm wide), biconvex, film-coated tablets, with “TAK” and “ALG-12.5” printed in grey ink on one side.
Vipidia 6,25 mg filmovertrukne tabletter Hver tablet indeholder alogliptinbenzoat svarende til 6,25 mg alogliptin.
Vipidia 6.25 mg film-coated tablets Each tablet contains alogliptin benzoate equivalent to 6.25 mg alogliptin.
Tillæg af 25 mg alogliptin én gang dagligt til metforminhydrochloridbehandling (gennemsnitlig dosis = 1.847 mg) medførte statistisk signifikante forbedringer i HbA1c og fasteplasmaglucose fra baseline til uge 26 sammenlignet med tillæg af placebo (tabel 2).
The addition of 25 mg alogliptin once daily to metformin hydrochloride therapy (mean dose = 1,847 mg) resulted in statistically significant improvements from baseline in HbA1c and fasting plasma glucose at Week 26 when compared to the addition of placebo (Table 2).
Det skal du vide, før du begynder at tage Vipidia Sådan skal du tage Vipidia Bivirkninger
What Vipidia is and what it is used for What you need to know before you take Vipidia How to take Vipidia
Flere af de patienter, der fik 25 mg alogliptin (7,8 %), nåede i uge 26 behandlingsmålet for HbA1c på ≤ 7,0 % sammenlignet med de placebobehandlede patienter (0,8 %).
More patients receiving 25 mg alogliptin (7.8%) achieved target HbA1c levels of ≤ 7.0% compared to those receiving placebo (0.8%) at Week 26.
- Vipidia 6,25 mg filmovertrukne tabletter (tabletter) er svagt pink, ovale (ca. 9,1 mm lange og 5,1 mm brede), bikonvekse, filmovertrukne tabletter med "TAK" og "ALG-6.25" trykt i gråt på den ene side.
- Vipidia 6.25 mg film-coated tablets (tablets) are light pink, oval (approximately 9.1 mm long by 5.1 mm wide), biconvex, film-coated tablets, with “TAK” and “ALG-6.25” on printed in grey ink on one side.
Vipidia 25 mg filmovertrukne tabletter Hver tablet indeholder alogliptinbenzoat svarende til 25 mg alogliptin.
Vipidia 25 mg film-coated tablets Each tablet contains alogliptin benzoate equivalent to 25 mg alogliptin.
Signifikant flere patienter, der fik 25 mg alogliptin (44,4 %), nåede i uge 26 behandlingsmålet for HbA1c på ≤ 7,0 % sammenlignet med de placebobehandlede patienter (18,3 %) (p < 0,001).
Significantly more patients receiving 25 mg alogliptin (44.4%) achieved target HbA1c levels of ≤ 7.0% compared to those receiving placebo (18.3%) at Week 26 (p<0.001).
Udseende og pakningsstørrelser - Vipidia 25 mg filmovertrukne tabletter (tabletter) er svagt røde, ovale (ca. 9,1 mm lange og 5,1 mm brede), bikonvekse, filmovertrukne tabletter med "TAK" og "ALG-25" trykt i gråt på den ene side.
What Vipidia looks like and contents of the pack - Vipidia 25 mg film-coated tablets (tablets) are light red, oval (approximately 9.1 mm long by 5.1 mm wide), biconvex, film-coated tablets, with “TAK” and “ALG-25” printed in grey ink on one side.
- Øvrige indholdsstoffer: Mannitol, mikrokrystallinsk cellulose, hydroxypropylcellulose, croscarmellosenatrium, magnesiumstearat, hypromellose, titandioxid (E171), rød jernoxid (E172), macrogol 8000, shellac og sort jernoxid (E172).
Each 25 mg tablet contains alogliptin benzoate equivalent to 25 mg alogliptin, - The other ingredients are: mannitol, microcrystalline cellulose, hydroxypropylcellulose, croscarmellose sodium, magnesium stearate, hypromellose, titanium dioxide (E171), red iron oxide (E172), macrogol 8000, shellac and black iron oxide (E172).
LÆGEMIDLETS NAVN Vipidia 12,5 mg tabletter alogliptin
NAME OF THE MEDICINAL PRODUCT Vipidia 12.5 mg tablets alogliptin
LÆGEMIDLETS NAVN Vipidia 25 mg tabletter alogliptin
NAME OF THE MEDICINAL PRODUCT Vipidia 25 mg tablets alogliptin
Betydeligt flere af de patienter, der fik 25 mg alogliptin (34,8 %), nåede i uge 26 behandlingsmålet for HbA1c på ≤ 7,0 % sammenlignet med de placebobehandlede patienter (18,2 %) (p = 0,002).
Significantly more patients receiving 25 mg alogliptin (34.8%) achieved target HbA1c levels of ≤ 7.0% compared to those receiving placebo (18.2%) at Week 26 (p=0.002).
• leverproblemer, der viser sig som kvalme eller opkastning, mavesmerter, usædvanlig eller uforklarlig træthed, manglende appetit, mørkfarvet urin eller gulfarvning af huden eller det hvide i øjnene.
loss of appetite, dark urine or yellowing of your skin or the whites of your eyes.
- Øvrige indholdsstoffer: Mannitol, mikrokrystallinsk cellulose, hydroxypropylcellulose, croscarmellosenatrium, magnesiumstearat, hypromellose, titandioxid (E171), gul jernoxid (E172), macrogol 8000, shellac og sort jernoxid (E172).
Each 12.5 mg tablet contains alogliptin benzoate equivalent to 12.5 mg alogliptin - The other ingredients are: mannitol, microcrystalline cellulose, hydroxypropylcellulose, croscarmellose sodium, magnesium stearate, hypromellose, titanium dioxide (E171), yellow iron oxide (E172), macrogol 8000, shellac and black iron oxide (E172).
LÆGEMIDLETS NAVN Vipidia 6,25 mg tabletter alogliptin
NAME OF THE MEDICINAL PRODUCT Vipidia 6.25 mg tablets alogliptin
Gule, ovale (ca. 9,1 mm lange og 5,1 mm brede), bikonvekse, filmovertrukne tabletter med "TAK" og "ALG-12.5" trykt i gråt på den ene side.
Yellow, oval (approximately 9.1 mm long by 5.1 mm wide), biconvex, film-coated tablets with “TAK” and “ALG-12.5” printed in grey ink on one side.
Svagt røde, ovale (ca. 9,1 mm lange og 5,1 mm brede), bikonvekse, filmovertrukne tabletter med "TAK" og "ALG-25" trykt i gråt på den ene side.
Light red, oval (approximately 9.1 mm long by 5.1 mm wide), biconvex, film-coated tablets with “TAK” and “ALG-25” printed in grey ink on one side.
Tillæg af 25 mg alogliptin én gang dagligt til pioglitazonbehandling (gennemsnitlig dosis = 35,0 mg, med eller uden metformin eller sulfonylurinstof) resulterede i statistisk signifikante forbedringer i HbA1c og fasteplasmaglucose fra baseline til uge 26, sammenlignet med placebo (tabel 2).
Alogliptin as add-on therapy to a thiazolidinedione The addition of 25 mg alogliptin once daily to pioglitazone therapy (mean dose = 35.0 mg, with or without metformin or a sulphonylurea) resulted in statistically significant improvements from baseline in HbA1c and fasting plasma glucose at Week 26 when compared to the addition of placebo (Table 2).
LÆGEMIDLETS NAVN Vipidia 6,25 mg filmovertrukne tabletter alogliptin
NAME OF THE MEDICINAL PRODUCT Vipidia 6.25 mg film-coated tablets alogliptin
LÆGEMIDLETS NAVN Vipidia 12,5 mg filmovertrukne tabletter alogliptin
NAME OF THE MEDICINAL PRODUCT Vipidia 12.5 mg film-coated tablets alogliptin
Svagt pink, ovale (ca. 9,1 mm lange og 5,1 mm brede), bikonvekse, filmovertrukne tabletter med "TAK" og "ALG-6.25" trykt i gråt på den ene side.
Light pink, oval (approximately 9.1 mm long by 5.1 mm wide), biconvex, film-coated tablets with “TAK” and “ALG-6.25” printed in grey ink on one side.
Det kan være, at din læge vil reducere din dosis af sulfonylurinstof eller insulin, hvis du tager et af disse midler sammen med Vipidia, så du kan undgå, at dit blodsukker bliver for lavt (hypoglykæmi).
Your doctor may want to reduce your dose of sulphonylurea or insulin when you take any of them together with Vipidia in order to avoid too low blood sugar (hypoglycaemia) - if you have kidney disease, you can still take this medicine but your doctor may reduce the dose - if you have liver disease - if you suffer from heart failure - if you are taking insulin or an anti-diabetic medicine, your doctor may want to reduce your dose of the other anti-diabetic medicine or insulin when you take either of them together with Vipidia in order to avoid low blood sugar - if you have or have had a disease of the pancreas
LÆGEMIDLETS NAVN Vipidia 25 mg filmovertrukne tabletter alogliptin
NAME OF THE MEDICINAL PRODUCT Vipidia 25 mg film-coated tablets alogliptin
Behandlingskorrigeret ændring i HbA1c fra baseline (%)† (en-sidet KI)
Treatment-corrected change from baseline in HbA1c (%)†
Gennem-snitlig ændring i HbA1c fra baseline (%)†
Mean change from baseline in HbA1c (%)† (SE)
Signifikant flere af de patienter, der fik 25 mg alogliptin plus 30 mg pioglitazon og metformin (33,2 %), nåede i uge 52 behandlingsmålet for HbA1c på ≤ 7,0 % sammenlignet med de patienter, der fik 45 mg pioglitazon og metformin (21,3 %) (p < 0,001).
30 mg pioglitazone and metformin (33.2%) achieved target HbA1c levels of ≤ 7.0% compared to those receiving 45 mg pioglitazone and metformin (21.3%) at Week 52 (p<0.001).
Tillægsbehandlingsstudier Alogliptin 25 mg én gang dagligt sammen med metformin i forhold til et sulfonylurinstof + metformin (n = 537)
Add-on combination therapy studies Alogliptin 25 mg once daily with metformin vs a sulphonylurea + metformin
Alogliptin som enkeltstofsbehandling
Alogliptin as monotherapy
• CVMP bør revurdere begrundelserne for suspenderingen efter et år, eller så snart udvalget får forelagt nye data til vurdering.
• The CVMP should review the grounds for suspension after one year, or as soon as new data are submitted to the Committee for evaluation.
BILAG II FAGLIGE KONKLUSIONER OG BEGRUNDELSER FOR SUSPENDERING AF MARKEDSFØRINGSTILLADELSERNE
ANNEX II SCIENTIFIC CONCLUSIONS AND GROUNDS FOR SUSPENSION OF THE MARKETING AUTHORISATIONS
Under sådanne omstændigheder skal tilbageholdelsestiden være mindst 28 dage.
In such circumstances, the meat withdrawal period should be not less than 28 days.
Sådanne restkoncentrationer er til fare for forbrugerne, navnlig personer, der er overfølsomme for penicillin.
Such residues present a hazard to the consumer, particularly those who are sensitised to penicillin.
Fastsættelse af MRL-værdier for penicillin
Establishment of MRLs for Penicillin
Sverige Forenede Kongerige
Sweden United Kingdom
I forbindelse med indbringelsen af denne sag blev CVMP anmodet om at afgive en udtalelse om tilbageholdelsestiden.
For the purposes of this referral, the CVMP was requested to give its opinion with regard to the withdrawal period.
Det er ikke aktivt mod penicillinaseproducerende stammer.
It is not active against penicillinase-producing strains.
Forekomst af subterapeutiske plasmakoncentrationer af antibiotika anses for en vigtig faktor i resistensdannelse.
The occurrence of sub-therapeutic plasma concentrations of antibiotics is regarded as an important factor in the development of resistance.
De fleste nyere undersøgelser er udført med hensigtsmæssig analyseteknik.
More recent studies were carried out using appropriate analytical methodology.
CVMP rådede ikke over restkoncentrationsdata for de andre arter, der er omfattet af markedsføringstilladelserne såsom heste, geder og fjerkræ.
No residues depletion data were available to the CVMP for the other species for which Marketing Authorisations exist, such as horses, goats and poultry.
Anbefalingerne var baseret på resultater af undersøgelser i mennesker, men i JECFA var man vidende om, at denne ADI-værdi ikke fuldstændigt fjerner risikoen hos meget følsomme individer.
The recommendation was based on the results of studies in humans, whilst JECFA was aware that this ADI does not absolutely remove the risk to exquisitely sensitive individuals.
- Aziende Chimiche Riunite Angelini Francesco
S.p.A. - Aziende Chimiche Riunite Angelini Francesco
Grampositive bakterier er mere følsomme end gramnegative.
Gram-positive bacteria are more susceptible than Gramnegatives.
In vitro MIC-værdierne for følsomme organismer ligger i intervallet 0,06 µg/ml til 0,125 µg/ml.
The in vitro MICs for sensitive organisms are in the range of 0.06 µg/ml and 0.125 µg/ml.
Det stod klart, at penicillinrester hos forbrugere har medført allergiske reaktioner, som i visse tilfælde har været alvorlige.
It was evident that penicillin residues have caused allergic reactions in consumers and that some of these reactions have been serious.
CVMP bemærkede imidlertid, at plasmakoncentrationerne af benzylpenicillin var subterapeutiske sammenholdt med in vitro MICværdierne for mange organismer.
However the CVMP noted that plasma concentrations of benzylpenicillin were sub-therapeutic compared to the in vitro MIC values for many organisms.
BILAG I: LISTE OVER VETERINÆRLÆGEMIDDELPRODUKTER BASERET PÅ BENZATHINPENICILLIN TIL DYR BESTEMT TIL LEVNEDSMIDDELPRODUKTION OG INDEHAVERE AF MARKEDSFØRINGSTILLADELSE I EC MEDLEMSSTATERNE, ISLAND AND NORGE
ANNEX I: LIST OF NAMES OF THE VETERINARY MEDICINAL PRODUCTS BASED ON BENZATHINE PENICILLIN FOR FOOD PRODUCING ANIMALS AND MARKETING AUTHORISATION HOLDERS IN EU MEMBER STATES, ICELAND AND NORWAY
Efter at man var blevet opmærksom på de problemer, der er forbundet med de anvendte bioassays, udførtes nye undersøgelser med mere hensigtsmæssige analyseteknikker.
Following the identification of the problems associated with the bioassays, new studies were carried out using more appropriate analytical techniques.
På baggrund af kendskabet til tilfælde af allergiske reaktioner ved meget lave doser anbefalede JEFCA, at den daglige indtagelse af benzylpenicillin i føden skulle holdes så lavt som praktisk muligt og under alle omstændigheder under 30 µg.
Being aware of cases of allergic reactions at very low doses, JECFA recommended that the daily intake of benzylpenicillin from food be kept as low as practicable, and in any case below 30 μg.
Til fastsættelse af MRL-værdier for penicillinerne har CVMP benyttet samme fremgangsmåde som JECFA.
In setting MRLs for the penicillins, the CVMP adopted the same approach as JECFA.
• de nu godkendte tilbageholdelsestider er ikke tilstrækkelige til at sikre, at levnedsmidler hidrørende fra behandlede dyr ikke indeholder restkoncentrationer af lægemidler, som kan udgøre en sundhedsfare for forbrugeren,
• the currently authorised withdrawal periods are inadequate to ensure that foodstuffs obtained from the treated animal do not contain residues which might constitute a health hazard to the consumer;
Som følge heraf må restkoncentrationerne antages at være undervurderet.
Consequently the residues were probably underestimated.
Generelle anbefalinger
Overall Recommendations
De af CVMP fastlagte MRL-værdier var således 50 µg/kg for spiseligt væv.
MRLs established by the CVMP were 50 µg/kg for edible tissues.
Lohner Str. 19 D-49377 Vechta
Lohner Str. 19 D-49377 Vechta Germany
Benzylpenicillin er et baktericidt antibiotikum, som er virksomt mod de fleste grampositive bakterier, gramnegative kokker og visse andre gramnegative bakterier, spirochaeter og actinomyceter.
Benzylpenicillin is a bactericidal antibiotic with a spectrum of activity against most Gram-positive bacteria, Gram-negative cocci and some other Gram-negative bacteria, spirochaetes and actinomycetes.
Undersøgelser af restkoncentrationernes nedbrydning
Residues depletion studies