FrancophonIA/ELRC3.0 huggingface dataset:
English: The European Medicines Agency decided that Tyverb's benefits are greater than its risks and it can be authorised for use in the EU.
Danish: Det Europæiske Lægemiddelagentur konkluderede, at fordelene ved Tyverb opvejer risiciene, og at det kan godkendes til anvendelse i EU.
English: Why is Tyverb authorised in the EU?
Danish: Hvorfor blev Tyverb godkendt i EU?
English: What are the risks associated with Tyverb?
Danish: Hvilke risici er der forbundet med Tyverb?
English: ‘Advanced' means that the cancer has started to spread and ‘metastatic' means that the cancer has already spread to other parts of the body;
Danish: "Fremskreden" betyder, at kræften er begyndt at sprede sig, og "metastatisk" betyder, at den allerede har bredt sig til andre dele af kroppen
English: Tyverb contains the active substance lapatinib.
Danish: Tyverb indeholder det aktive stof lapatinib.
English: 219 of the women had cancer that was producing large quantities of HER2.
Danish: 219 af kvinderne havde kræft, som producerede store mængder HER2.
English: Side effects reported with Tyverb are carefully evaluated and any necessary action taken to protect patients.
Danish: Bivirkninger rapporteret for Tyverb vurderes omhyggeligt, og der tages de nødvendige forholdsregler for at beskytte patienterne.
English: Tyverb is available as tablets (250 mg) and the recommended dose is 4 tablets a day when used with trastuzumab, 5 tablets a day when it is used with capecitabine, and 6 tablets a day when taken with an aromatase inhibitor.
Danish: Tyverb fås som tabletter (250 mg), og den anbefalede dosis er 4 tabletter dagligt, når det anvendes sammen med trastuzumab, 5 tabletter dagligt, når det anvendes sammen med capecitabin, og 6 tabletter dagligt, når det tages sammen med en aromatasehæmmer.
English: The doctor may decide to interrupt or stop treatment in patients experiencing certain side effects, especially those affecting the heart, lungs or liver.
Danish: Lægen kan beslutte midlertidigt at afbryde eller helt stoppe behandlingen af patienter, som får visse bivirkninger, især bivirkninger relateret til hjertet, lungerne eller leveren.
English: This means that there was more evidence to come about the effectiveness of the medicine.
Danish: Det betyder, at der forventedes yderligere dokumentation for lægemidlet.
English: About a quarter of breast cancers produce HER2.
Danish: I omkring en fjerdedel af alle brystkræfttilfælde udtrykkes der HER2.
English: Tyverb can only be obtained with a prescription and should only be started by a doctor who has experience in giving cancer medicines.
Danish: Tyverb udleveres kun efter recept, og behandlingen bør kun iværksættes af en læge med erfaring i brug af kræftmedicin.
English: The women had not received trastuzumab or an aromatase inhibitor before entering this study.
Danish: Kvinderne havde forud for studiet ikke fået trastuzumab eller en aromatasehæmmer.
English: The company that markets Tyverb will evaluate ways to predict resistance (the medicine becoming less effective) in breast cancer patients taking Tyverb with other cancer medicines.
Danish: Den virksomhed, der markedsfører Tyverb, vil overveje måder, hvorpå man kan forudsige modstandsdygtighed (hvor lægemidlet bliver mindre effektivt) hos de brystkræftpatienter, der får Tyverb sammen med andre kræftlægemidler.
English: The most common side effects with Tyverb (which may affect more than 1 in 4 patients) are rash and side effects affecting the stomach and gut (such as diarrhoea, nausea (feeling sick) and vomiting).
Danish: De hyppigste bivirkninger ved Tyverb (som optræder hos mere end 1 ud af 4 patienter) er udslæt og mave-tarm-relaterede bivirkninger (bl.a. diarré, kvalme og opkastning).
English: The second study compared Tyverb alone with a combination of Tyverb plus trastuzumab.
Danish: I det andet studie blev Tyverb alene sammenlignet med en kombination af Tyverb og trastuzumab.
English: Tyverb in combination with other cancer medicines has been shown to improve survival of patients with breast cancer that produces large quantities of HER2, and its side effects are considered acceptable.
Danish: Det er påvist, at Tyverb i kombination med andre kræftlægemidler forbedrer overlevelsen hos patienter med brystkræft, der producerer store mængder HER2, og dets bivirkninger anses for at være acceptable.
English: Palmar-plantar erythrodysaesthesia (rash and numbness on the palms and soles) is also very common when Tyverb is taken with capecitabine.
Danish: Hånd-fod-syndrom (udslæt og følelsesløshed på håndflader og fodsåler) er også meget almindeligt, når Tyverb tages sammen med capecitabin.
English: For the full list of side effects and restrictions with Tyverb, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger og begrænsninger ved Tyverb fremgår af indlægssedlen.
English: Tyverb is a cancer medicine used to treat patients with breast cancer that has been shown to be ‘expressing' large amounts of HER2.
Danish: Tyverb er et kræftlægemiddel, der anvendes til behandling af patienter med brystkræft, som "udtrykker" store mængder HER2.
English: It involved 296 women with metastatic disease that was producing large quantities of HER2 and got worse despite treatment with trastuzumab and other cancer medicines (including anthracyclines and taxanes).
Danish: Det omfattede 296 kvinder med metastastisk sygdom, som producerede store mængder HER2, og som forværredes på trods af behandling med trastuzumab og andre kræftlægemidler (herunder antracykliner og taxaner).
English: It involved 1,286 women who had been through the menopause with metastatic breast cancer that was sensitive to hormones.
Danish: Det omfattede 1 286 kvinder, som var forbi overgangsalderen og havde metastatisk brystkræft, der var følsom over for hormoner.
English: This means that the cancer produces a specific protein called HER2 (also known as ErbB2) in large quantities on the surface of the cancer cells.
Danish: Herved forstås, at kræften producerer store mængder af et særligt protein, HER2 (også kaldet ErbB2), på overfladen af kræftcellerne.
English: What benefits of Tyverb have been shown in studies?
Danish: Hvilke fordele viser studierne, at der er ved Tyverb?
English: • in combination with an aromatase inhibitor (another type of cancer medicine) in women who have been through the menopause, when the cancer is metastatic and responds to hormones.
Danish: • i kombination med en aromatasehæmmer (en anden type kræftlægemiddel) hos kvinder, der er forbi overgangsalderen, når kræften er metastatisk og responderer på hormoner.
English: In addition, women taking the combination survived for 14.0 months on average, compared with 9.5 months in those taking Tyverb alone.
Danish: Derudover overlevede de kvinder, som fik kombinationen, i gennemsnit 14,0 måneder sammenholdt med 9,5 måneder for dem, der fik Tyverb alene.
English: How is Tyverb used?
Danish: Hvordan anvendes Tyverb?
English: • in combination with trastuzumab for metastatic cancer that does not respond to hormones (hormone receptor-negative disease), and which got worse when previously treated with a combination of trastuzumab and other cancer medicines (chemotherapy);
Danish: • i kombination med trastuzumab til metastatisk kræft, der ikke responderer på hormoner (hormonreceptornegativ sygdom), og som er blevet værre efter tidligere behandling med en kombination af trastuzumab og andre kræftlægemidler (kemoterapi)
English: • in combination with capecitabine (another cancer medicine) when the cancer is advanced or metastatic and got worse following previous treatment including an anthracycline and a taxane (other types of cancer medicine), and following treatment of the patient's metastatic disease with trastuzumab (another cancer medicine).
Danish: • i kombination med capecitabin (et andet kræftlægemiddel), hvis kræften er fremskreden eller metastatisk og er blevet værre efter en tidligere behandling, herunder antracykliner og taxaner (andre kræftlægemidler), og efter behandling af patientens metastatiske sygdom med trastuzumab (et andet kræftlægemiddel).
English: These medicines work by blocking enzymes known as protein kinases, which can be found in some receptors (targets) on the surface of cancer cells including HER2.
Danish: Proteinkinaser er enzymer, der findes i visse receptorer (mål) på overfladen af kræftceller, herunder HER2.
English: The first study compared Tyverb in combination with capecitabine, with capecitabine taken alone.
Danish: I det første studie blev Tyverb i kombination med capecitabin sammenlignet med capecitabin taget alene.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Tyverb have also been included in the summary of product characteristics and the package leaflet.
Danish: Der er desuden anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Tyverb.
English: How does Tyverb work?
Danish: Hvordan virker Tyverb?
English: HER2 is a receptor for a substance called epidermal growth factor which stimulates the cancer cells to grow uncontrollably.
Danish: HER2 er en receptor for et stof, der hedder epidermal vækstfaktor, og som stimulerer kræftcellerne, så de deler sig på ukontrolleret vis. Ved at blokere HER2-receptorerne er Tyverb med til at begrænse kræftens vækst.
English: Women taking Tyverb with trastuzumab lived without their disease getting worse for 12.0 weeks on average, compared with 8.1 weeks in those taking Tyverb alone.
Danish: De kvinder, som fik Tyverb i kombination med trastuzumab, levede i gennemsnit 12,0 uger, uden at sygdommen forværredes, sammenholdt med 8,1 uger for dem, der fik Tyverb alene.
English: Women taking Tyverb with capecitabine survived for an average of 75 weeks, and those taking capecitabine alone survived for an average of 64.7 weeks.
Danish: Kvinder, som fik Tyverb i kombination med capecitabin, overlevede gennemsnitligt i 75 uger sammenlignet med 64,7 uger for dem, som fik capecitabin alene.
English: The women whose cancer was producing large quantities of HER2 taking Tyverb in combination with letrozole survived for an average of 35.4 weeks without their disease getting worse.
Danish: De kvinder, hvis kræft producerede store mængder HER2, og som fik Tyverb i kombination med letrozol, overlevede gennemsnitligt i 35,4 uger, uden at sygdommen forværredes, sammenholdt med 13,0 uger hos dem, der fik placebo i kombination med letrozol.
English: The third study compared Tyverb with placebo (a dummy treatment), both of which were taken together with letrozole (an aromatase inhibitor).
Danish: De blev begge taget sammen med letrozol (en aromatasehæmmer).
English: Tyverb in combination with another cancer medicine was shown to be more effective than the comparator treatment in three main studies involving women with breast cancer.
Danish: I tre hovedstudier af kvinder med brystkræft fremgik det, at Tyverb i kombination med et andet kræftlægemiddel er mere effektivt end sammenligningsbehandlingen.
English: The women taking Tyverb in combination with capecitabine lived for an average of 23.9 weeks without their disease getting worse, as assessed by their doctors, compared with 18.3 weeks in the women taking capecitabine alone.
Danish: Efter lægernes vurdering levede de kvinder, som fik Tyverb i kombination med capecitabin, gennemsnitligt 23,9 uger, uden at sygdommen forværredes, sammenlignet med 18,3 uger for dem, som fik capecitabin alene.
English: It involved 408 women with advanced or metastatic disease that was producing large quantities of HER2 who had already been treated with anthracyclines, taxanes and trastuzumab but whose disease had got worse or come back.
Danish: Kvinderne var allerede blevet behandlet med antracykliner, taxaner og trastuzumab, men sygdommen var enten blevet værre eller kommet tilbage.
English: Portugal capsule
Danish: Portugal kapsler
English: Benzstraße 1
Danish: KG Benzstraße 1
English: Castilla 2, Edificio Berlín 2ª planta Parque Empresarial San Fernando
Danish: Edificio Berlín 2ª planta Parque Empresarial San Fernando
English: 28830 San Fernando de Henares (Madrid) Spain
Danish: 28830 San Fernando de Henares Madrid
English: Unit 34/35, Block A Dunboyne Business Park Dunboyne
Danish: Unit 34/35, Block A Dunboyne Business Park Dunboyne Co. Meath Ireland
English: Benzstr.
Danish: KG Benzstr.
English: Meda AS, Askerveien 61, Postboks 194, 1371 Asker
Danish: Meda AS Askerveien 61 Postboks 194 1371 Asker Norway
English: SANOFI AVENTIS FRANCE 1-13 boulevard Romain Rolland
Danish: SANOFI AVENTIS FRANCE 1-13 boulevard Romain Rolland 75014 PARIS
English: MEDA PHARMACEUTICALS S.A., GREECE 3 Evrytanias Str., Halandri, 15231, Attiki, Greece
Danish: 3 Evrytanias Str., Halandri 15231, Attiki
English: Belgium Meda Pharma s.a. Chaussée de la Hulpe 166 1170 Brussels
Danish: Chaussée de la Hulpe 166 1170 Brussels Belgium
English: 170 09 Solana Box 906
Danish: 170 09 Solna Box 906
English: List of the names, pharmaceutical forms, strengths of the medicinal products, routes of administration, marketing authorisation holders in the member states for bromocriptine-containing medicinal products indicated in the “prevention or suppression of physiological lactation in the immediate post-partum period and in the late post-partum period”
Danish: Bilag I Fortegnelse over lægemidlernes navne, lægemiddelform, styrker, administrationsvej, og indehavere af markedsføringstilladelser i medlemsstaterne
English: Germany betapharm Arzneimittel GmbH
Danish: Tyskland betapharm Arzneimittel GmbH Kobelweg 95
English: Maksimirska 120/V, Zagreb
Danish: Maksimirska 120/V Zagreb 10 000 Croatia
English: S.C. BIOFARM S.A. Str. Logofăt Tăutu nr. 99, sector 3,
Danish: Str. Logofăt Tăutu nr. 99 sector 3, Bucureşti
English: Medochemie Ltd Constantinoupoleos 1-10 Street
Danish: Medochemie Ltd Constantinoupoleos 1-10 Street Lemesos 3501
English: Gedeon Richter Plc Gyömrői út 19-21.
Danish: Gedeon Richter Plc Gyömrői út 19-21 H-1103 Budapest Hungary
English: Czech Republic Medochemie Ltd. Konstantinoupoleos Str. 1_10 3011 Limassol - Tsiflikoudia Cyprus
Danish: Constantinoupoleos Str. 1_10 3011 Limassol - Tsiflikoudia Cyprus
English: Kodaňská 1441/46
Danish: Kodaňská 1441/46 100 00 Praha 10
English: Luxembourg MEDA Pharma GmbH & Co. KG
Danish: Luxembourg MEDA Pharma GmbH & Co.
English: Parlodel 10 mg 10 mg
Danish: Parlodel 10 mg
English: MEDOCRIPTINE 2,5 mg
Danish: MEDOCRIPTINE 2,5 mg 2,5 mg
English: Bromocriptin AbZ 2,5 mg
Danish: Bromocriptin AbZ 2,5 mg 2,5 mg
English: Meda AS, Solvang 8, DK-3450 Allerød, Denmark
Danish: DK-3450 Allerød Denmark
English: MEDA PHARMA 25, boulevard de l'Amiral Bruix,
Danish: 25, boulevard de l'Amiral Bruix 75016 Paris
English: BROMOCRIPTINRICHTER
Danish: BROMOCRIPTIN
English: Parlodel 10mg Tablets capsule
Danish: Parlodel 10mg Tablets kapsler
English: Slovak Republic MEDA Pharma s.r.o.
Danish: MEDA Pharma s.r.o.
English: 89079 Ulm germany bromocriptin-ct 2,5mg Tabletten
Danish: AbZ-Pharma GmbH Graf-Arco-Str. 3 89079 Ulm Germany bromocriptin-ct 2,5mg Tabletten
English: United Kingdom Teva UK Limited, Brampton Road,
Danish: Teva UK Limited Brampton Road, Hampden Park Eastbourne, East Sussex BN22 9AG
English: Parlodel 5mg Tablets capsule
Danish: Parlodel 5mg Tablets kapsler
English: Parlodel 10 mg capsules
Danish: Parlodel 10 mg capsules 10 mg
English: Parlodel 5 mg capsules
Danish: Parlodel 5 mg capsules 5 mg
English: Pravidel 2,5 mg Tabletten
Danish: Pravidel 2,5 mg Tabletten 2,5 mg
English: Bromocriptinratiopharm 2,5mg Tabletten
Danish: Bromocriptin-ratiopharm 2,5mg Tabletten
English: Parlodel 2,5 mg 2.5 mg
Danish: Parlodel 2,5 mg
English: Bromergon 2,5 mg tablete
Danish: Bromergon 2,5 mg tablete 2,5 mg
English: Kobelweg 95
Danish: Verovškova 57
English: BromocriptinRichter 2,5 mg tabletta
Danish: Bromocriptin-Richter 2,5 mg tabletta
English: Verovškova 57, 1000 Ljubljana, Slovenia
Danish: 1526 Ljubljana
English: Slovak Republic Medochemie Ltd. 1-10 Constantinoupoleos St. 3011 Limassol,
Danish: 1-10 Constantinoupoleos St. 3011 Limassol Cyprus
English: Bromocriptine Sopharma
Danish: Bromocriptine Sopharma 2,5 mg
English: Parlodel 2.5mg Tablets
Danish: Parlodel 2.5mg Tablets 2,5 mg
English: BROMOCRIPTIN 2.5 mg coated tablet
Danish: Bromocriptine 2.5mg Tablets
English: What was Cavoley expected to be used for?
Danish: Hvad forventedes Cavoley anvendt til?
English: What is Cavoley?
Danish: Hvad er Cavoley?
English: granulocyte-colony-stimulating factor (G-CSF).
Danish: der hedder granulocyt-koloni-stimulerende faktor (C-CSF).
English: On 16 November 2016, Gedeon Richter Plc officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Cavoley, for reducing neutropenia.
Danish: Den 16. november 2016 meddelte Gedeon Richter Plc officielt Udvalget for Lægemidler til Mennesker (CHMP), at virksomheden ønsker at tilbagetrække sin ansøgning om markedsføringstilladelse for Cavoley til behandling af neutropeni.
English: Cavoley was developed as a ‘biosimilar' medicine.
Danish: Cavoley blev udviklet som et "biosimilært" lægemiddel.
English: Neutropenia is a side effect of certain cytotoxic (cell-killing) cancer treatments because the treatments also kill white blood cells.
Danish: Neutropeni er en bivirkning ved visse celledræbende (cytotoksiske) kræftbehandlinger, idet behandlingerne også slår hvide blodlegemer ihjel.
English: A further study in patients receiving cancer medicines compared the safety and effectiveness of Cavoley and Neulasta.
Danish: En yderligere undersøgelse af patienter, der fik kræftmedicin, sammenlignede sikkerheden ved og virkningen af Cavoley og Neulasta.
English: Filgrastim is very similar to a human protein called
Danish: Filgrastim svarer i høj grad til et menneskeligt protein,
English: In its letter notifying the Agency of the withdrawal of the application, the company stated that having considered the CHMP's conclusion, it has decided to withdraw the application but to continue developing the product and follow the CHMP's advice to eliminate the remaining uncertainty.
Danish: I sit brev til agenturet om tilbagetrækningen af ansøgningen angav virksomheden, at den i lyset af CHMP's konklusion havde besluttet at tilbagetrække ansøgningen, men at den ville fortsætte udviklingen af lægemidlet og følge CHMP's råd om at fjerne den resterende usikkerhed.
English: The active substance in Cavoley, pegfilgrastim, consists of filgrastim that has been 'pegylated' (attached to a chemical called polyethylene glycol).
Danish: Det aktive stof i Cavoley, pegfilgrastim, består af filgrastim, der er blevet pegyleret, dvs. forbundet til et kemisk stof, der hedder polyethylenglykol.
English: Based on the review of the data and the company's response to the CHMP list of questions, at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Cavoley could not have been approved for reducing neutropenia.
Danish: På baggrund af gennemgangen af dataene og virksomhedens besvarelse af CHMP's liste med spørgsmål på tidspunktet for tilbagetrækningen af ansøgningen havde CHMP visse betænkeligheder og var af den foreløbige opfattelse, at Cavoley ikke kunne godkendes til behandling af neutropeni.
English: Cavoley is a medicine that contains the active substance pegfilgrastim, which stimulates the production of neutrophils (a type of white blood cell that fights infections).
Danish: Cavoley er et lægemiddel, der indeholder det aktive stof pegfilgrastim, som stimulerer dannelsen af neutrofiler (en type hvide blodlegemer, der bekæmper infektioner).
English: What consequences does this withdrawal have for patients in clinical trials?
Danish: Hvilke konsekvenser har tilbagetrækningen for patienter, der deltager i kliniske undersøgelser med Cavoley?
English: The company presented results of studies in healthy people designed to show that Cavoley is highly similar to its reference medicine Neulasta in terms of chemical structure, purity, the way it works and how the body handles the medicine.
Danish: Virksomheden fremlagde resultaterne af undersøgelser hos raske personer for at vise, at Cavoley i høj grad svarer til referencelægemidlet Neulasta, hvad angår stoffets kemiske struktur, renhed og virkningsmekanisme samt kroppens håndtering af lægemidlet.
English: How does Cavoley work?
Danish: Hvordan virker Cavoley?
English: The CHMP was concerned that study results had not shown that Cavoley was handled by the body in the same way as the reference medicine Neulasta.
Danish: CHMP var betænkelig ved, at resultaterne af undersøgelserne ikke havde vist, at Cavoley blev håndteret på samme vis i kroppen som referencelægemidlet Neulasta.
English: This means that Cavoley was intended to be highly similar to a biological medicine (the ‘reference medicine') already authorised in the European Union called Neulasta.
Danish: Det betyder, at det var hensigten, at Cavoley skulle svare til og indeholde det samme aktive stof som et biologisk lægemiddel, der allerede er godkendt i Den Europæiske Union ("referencelægemidlet").
English: Cavoley was to be used to reduce the duration of neutropenia and the occurrence of febrile neutropenia (neutropenia with fever).
Danish: Cavoley anvendes til at nedsætte varigheden af neutropeni og forekomsten af neutropeni med feber.
English: Therefore, at the time of the withdrawal, the CHMP was of the opinion that the company had not demonstrated that Cavoley is highly similar to Neulasta.
Danish: Derfor var CHMP på tidspunktet for tilbagetrækningen af den opfattelse, at virksomheden ikke havde påvist, at Cavoley i høj grad svarer til referencelægemidlet Neulasta.
English: The company informed the CHMP that there are no ongoing clinical trials or compassionate-use programmes for Cavoley.
Danish: Virksomheden har til CHMP oplyst, at der aktuelt ikke gennemføres kliniske undersøgelser eller programmer for anvendelse af Cavoley med særlig udleveringstilladelse.
English: Cavoley was to be used in cancer patients to reduce neutropenia (low levels of neutrophils).
Danish: Cavoley skulles anvendes til behandling af neutropeni (lavt antal neutrofiler) hos kræftpatienter.
English: Withdrawal of the marketing authorisation application for Cavoley (pegfilgrastim) EMA/822769/2016
Danish: EMA/822769/2016
English: The vaccine is then ready to use.
Danish: Vaccinen er derefter klar til brug.
English: Position on VP1 gene
Danish: Position på VP1 genet
English: ANNEX IV GROUNDS FOR ONE ADDITIONAL RENEWAL
Danish: BILAG IV BEGRUNDELSER FOR EN YDERLIGERE FORNYELSE
English: C T C G C C C A A T A The vaccine strain can be found in the spleen for at least 35 days.
Danish: C T C G C C C A A T A Vaccine stammen kan findes i leveren i mindst 35 dage.
English: The active substance being a principle of biological origin intended to produce active immunity is not within the scope of Regulation (EC) No 470/2009.
Danish: Den aktive substans som principielt er af biologisk oprindelse hvis formål er at producere aktiv immunitet falder ikke indenfor anvendelsesområdet af Forordning (EF) nr. 470/2009 .
English: ATCvet code: QI01BD03.
Danish: ATCvet-kode: QI01BD03
English: The concentrate is opalescent and homogeneous.
Danish: Koncentratet er opaliserende og homogent.
English: Due to the limited period the veterinary medicinal product Parvoduk has been placed on the market and the consequently limited post-marketing safety information, the CVMP at their meeting on 6-8 November 2018 decided that one five-year renewal is required.
Danish: Grundet den begrænsede periode, som veterinærlægemidlet Parvoduk har været på markedet og den som følge deraf begrænsede sikkerhedsinformation efter markedsføring, besluttede CVMP på mødet 6.-8. november, at en fornyelse efter 5 år er påkrævet.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 11/04/2014
Danish: DATO FOR FØRSTE TILLADELSE/FORNYELSE AF TILLADELSEN Dato for første markedsføringstilladelse:11/04/2014
English: Do not use in birds in lay (see section 4.3).
Danish: Må ikke anvendes til æglæggende fugle (se punkt 4.3).
English: Casein hydrolysate Aluminium hydroxide
Danish: Casein hydrolysat Aluminiumhydroxid