FrancophonIA/ELRC3.0 huggingface dataset:
English: In a study involving 814 patients with type 2 diabetes, Forxiga used in combination with metformin was at least as effective as a sulphonylurea (another type of diabetes medicines) used with metformin.
Slovenian: V študiji pri 814 bolnikih s sladkorno boleznijo tipa 2 je bilo zdravilo Forxiga v kombinaciji z metforminom vsaj tako učinkovito kot sulfonilsečnina (druga vrsta zdravila za zdravljenje sladkorne bolezni) v kombinaciji z metforminom.
English: How is Forxiga used?
Slovenian: Kako se zdravilo Forxiga uporablja?
English: The European Medicines Agency considered that Forxiga was effective for treating type 2 diabetes when given alone or in combination with other diabetes medicines which work in different ways.
Slovenian: Evropska agencija za zdravila je zaključila, da je zdravilo Forxiga učinkovito pri zdravljenju sladkorne bolezni tipa 2, kadar se uporablja kot samostojno zdravilo ali v kombinaciji z drugimi zdravili za zdravljenje sladkorne bolezni z drugačnimi mehanizmi delovanja.
English: In type 2 diabetes, it is used with appropriate diet and exercise in patients who cannot take metformin (another diabetes medicine).
Slovenian: Pri sladkorni bolezni tipa 2 se zdravilo Forxiga uporablja sočasno z ustrezno prehrano in telesno vadbo pri bolnikih, ki ne morejo jemati metformina (drugega zdravila za zdravljenje sladkorne bolezni).
English: The company will also conduct a study to estimate the frequency of diabetic ketoacidosis in patients with type 1 diabetes treated with Forxiga.
Slovenian: Izvedlo bo tudi študijo za oceno pogostnosti diabetične ketoacidoze pri bolnikih s sladkorno boleznijo tipa 1, zdravljenih z zdravilom Forxiga.
English: In two studies involving 1,648 patients with type 1 diabetes whose blood sugar was not controlled well enough on insulin alone, adding Forxiga 5 mg decreased HbA1c levels after 24 hours by 0.37% and by 0.42% more than adding placebo.
Slovenian: V dveh študijah, v katerih je sodelovalo 1 648 bolnikov s sladkorno boleznijo tipa 1, pri katerih sladkor v krvi ni bil zadovoljivo uravnan samo z insulinom, je dodajanje zdravila Forxiga v 5-miligramskem odmerku po 24 urah znižalo ravni HbA1c za 0,37 % in za 0,42 % več kot dodajanje placeba.
English: As blood is filtered by the kidneys, SGLT2 stops glucose in the bloodstream from being passed out into the urine.
Slovenian: Ko se kri filtrira skozi ledvice, soprenašalec SGLT2 prepreči, da bi se glukoza v krvnem obtoku izločala v urin.
English: The most common side effect with Forxiga in patients with type 2 diabetes (which may affect more than 1 in 10 people) is hypoglycaemia, especially when used in combination with a sulphonylurea or insulin.
Slovenian: Najpogostejši neželeni učinek zdravila Forxiga pri bolnikih s sladkorno boleznijo tipa 2 (ki se lahko pojavijo pri več kot 1 bolniku od 10) je hipoglikemija (nizka raven sladkorja v krvi), zlasti kadar se zdravilo uporablja v kombinaciji s sulfonilsečnino ali insulinom.
English: Forxiga increased the risk of diabetic ketoacidosis considerably in patients with type 1 diabetes and it is recommended for this condition only in overweight and obese patients.
Slovenian: Zdravilo Forxiga je pri bolnikih s sladkorno boleznijo tipa 1 močno povečalo tveganje diabetične ketoacidoze, zato se zanje priporoča le v primeru čezmerne telesne mase in debelosti.
English: Adding Forxiga to insulin treatment in patients with type 1 diabetes whose diabetes could not be controlled well enough with insulin was also effective.
Slovenian: Dodajanje zdravila Forxiga insulinu pri bolnikih s sladkorno boleznijo tipa 1, pri katerih bolezen ni zadovoljivo uravnana samo z insulinom, se je ravno tako izkazalo za učinkovito.
English: Forxiga contains the active substance dapagliflozin.
Slovenian: Zdravilo Forxiga vsebuje učinkovino dapagliflozin.
English: The active substance in Forxiga, dapagliflozin, blocks the action of a protein in the kidneys called sodium-glucose co-transporter 2 (SGLT2).
Slovenian: Učinkovina v zdravilu Forxiga, dapagliflozin, zavira delovanje beljakovine v ledvicah, imenovane natrijglukozni soprenašalec 2 (SGLT2).
English: By blocking the action of SGLT2, dapagliflozin causes the kidney to pass out more glucose in the urine, thereby reducing the levels of glucose in the blood.
Slovenian: Dapagliflozin z zaviranjem delovanja soprenašalca SGLT2 povzroči, da ledvice v urin izločijo več glukoze, kar zniža ravni glukoze v krvi.
English: In four other studies involving 2,370 patients, adding Forxiga to other diabetes medicines decreased HbA1c levels by 0.54-0.68 percentage points more than adding placebo after 24 weeks.
Slovenian: V štirih dodatnih študijah, v katerih je sodelovalo 2 370 bolnikov, je dodajanje zdravila Forxiga drugim zdravilom za zdravljenje sladkorne bolezni po 24 tednih znižalo ravni HbA1c za 0,54 do 0,68 odstotnih točk več kot dodajanje placeba.
English: In addition, beneficial reductions in weight and blood pressure occurred in patients treated with Forxiga.
Slovenian: Poleg tega so pri bolnikih, zdravljenih z zdravilom Forxiga, zabeležili koristno zmanjšanje telesne mase in znižanje krvnega tlaka.
English: In two studies involving 840 patients with type 2 diabetes, Forxiga when used alone decreased HbA1c levels by 0.66 percentage points more than placebo (a dummy treatment) after 24 weeks.
Slovenian: Zdravilo Forxiga, uporabljeno kot samostojno zdravilo, je v dveh študijah, v kateri je bilo vključenih 840 bolnikov s sladkorno boleznijo tipa 2, po 24 tednih znižalo ravni HbA1c za 0,66 odstotnih točk več kot placebo (zdravilo brez učinkovine).
English: Section 4.1 - Therapeutic indications
Slovenian: Poglavje 4.1 -Terapevtske indikacije
English: • This medicine is not given to prevent heart disease.
Slovenian: • To zdravilo se ne uporablja za preprečevanje bolezni srca.
English: The wording below should be inserted in this section
Slovenian: V to poglavje je treba vstaviti spodnje besedilo.
English: This section should be amended to reflect the wording below
Slovenian: To poglavje je treba spremeniti tako, da bo odražalo spodnje besedilo.
English: • This medicine is not effective for all lipid disorders.
Slovenian: • To zdravilo ni učinkovito pri vseh lipidnih motnjah.
English: Section 4.4 - Special warnings and precautions
Slovenian: Poglavje 4.4 - Posebna opozorila in previdnostni ukrepi
English: Acipimox is structurally related to nicotinic acid.
Slovenian: Acipimoks je strukturno podoben nikotinski kislini.
English: The risk of muscle toxicity is increased when nicotinic acid is administered concomitantly with a statin (i.e. a 3-hydroxy-3- methylglutaryl coenzyme A [HMGCoA] reductase inhibitor).
Slovenian: Tveganje mišične toksičnosti se poveča, če se nikotinska kislina uporablja sočasno s statinom (tj. zaviralcem 3-hidroksi-3-metilglutaril koencim A (HMG-CoA) reduktaze).
English: • Tell your doctor immediately if you have unexplained muscle pain, muscle tenderness or muscle weakness while you are taking this medicine
Slovenian: • Nemudoma se posvetujte z zdravnikom, če se med jemanjem tega zdravila pojavijo nepojasnjene bolečine v mišicah, občutljivost mišic ali mišična oslabelost.
English: In one study, Chinese patients taking nicotinic acid plus laropiprant concomitantly with simvastatin were reported to have a higher incidence of myopathy and rhabdomyolysis compared to Caucasians.
Slovenian: V eni študiji so poročali, da so imeli kitajski bolniki, ki so nikotinsko kislino in laropiprant jemali sočasno s simvastatinom, večjo incidenco miopatije in rabdomiolize v primerjavi z bolniki bele rase
English: It has not been shown that treatment of hyperlipoproteinaemia with acipimox leads to a reduction of cardiac morbidity or mortality.
Slovenian: Ni bilo dokazano, da zdravljenje hiperlipoproteinemije z acipimoksom zmanjša srčno obolevnost in umrljivost.
English: [Product name] is indicated as alternative or adjunct treatment to reduce triglyceride levels in patients who have not responded adequately to other treatments such as statin or fibrate treatment for:
Slovenian: Zdravilo X je indicirano kot alternativno ali dodatno zdravljenje za znižanje ravni trigliceridov pri bolnikih, ki se niso zadostno odzvali na druge oblike zdravljenja, kot je zdravljenje s statini ali fibrati zaradi:
English: This medicine contains acipimox, which is used to treat lipid disorders by reducing high blood levels of certain types of fats called triglycerides.
Slovenian: To zdravilo vsebuje acipimoks, ki se uporablja za zdravljenje lipidnih motenj, saj znižuje visoke ravni nekaterih vrst maščob, imenovanih trigliceridi, v krvi.
English: • hypertriglyceridaemia (Fredrickson type IV hyperlipoproteinaemia);
Slovenian: • hipertrigliceridemije (Fredricksonove hiperlipoproteinemije tipa IV); • hiperholesterolemije in hipertrigliceridemije (Fredricksonove hiperlipoproteinemije tipa IIb).
English: Annex III Amendments to relevant sections of the summary of product characteristics and package leaflets
Slovenian: Spremembe zadevnih poglavij povzetka glavnih značilnosti zdravila in navodil za uporabo
English: [Product name] capsules should be used in addition to other medicines, such as medicines called ‘statins' or ‘fibrates' or instead of these medicines where they may not be appropriate or of expected benefit.
Slovenian: Kapsule X je treba uporabljati kot dodatek drugim zdravilom, kot so zdravila, imenovana »statini« ali »fibrati«, ali kot nadomestek za ta zdravila, če ta niso primerna ali njihova korist ni pričakovana.
English: [Product name] capsules should only be used in patients where diet alone or other non-drug measures (weight loss or exercises) failed to correct the levels of these fats.
Slovenian: Kapsule X se smejo uporabljati samo pri bolnikih, pri katerih samo dieta ali drugi ukrepi brez zdravil (izguba telesne mase ali telesna vadba) niso znižali ravni teh maščob.
English: [Product name] should be used after other measures have been taken such as dietary changes and other non-pharmacological treatment (e.g. exercise, weight reduction).
Slovenian: Zdravilo X se sme uporabiti šele po uvedbi drugih ukrepov, kot so spremembe prehranjevanja in druge nefarmakološke oblike zdravljenja (npr. telesna vadba, zmanjšanje telesne mase).
English: [Product name] capsules prevent the release of fatty acids from fatty tissue and decrease the blood level of triglycerides and cholesterol.
Slovenian: Kapsule X preprečujejo sproščanje maščobnih kislin iz maščobnega tkiva in znižajo raven trigliceridov ter holesterola v krvi.
English: Package leaflet
Slovenian: Priloga III
English: The procedure started on 20 September 2007.
Slovenian: Postopek se je začel dne 20. septembra 2007.
English: London, 11 July 2008 Doc.
Slovenian: London, 11. julij 2008 Sklic dok.
English: Ref. EMEA/CHMP/411086/2008
Slovenian: EMEA/CHMP/411084/2008
English: A Decision was issued by the European Commission on 11 July 2008.
Slovenian: Evropska komisija je odločbo izdala dne 11. julija 2008.
English: The Marketing Authorisation Holder provided supplementary information on 6 December 2007.
Slovenian: Imetnik dovoljenja za promet je dne 6. decembra 2007 predložil dodatne informacije.
English: The basis for referral was that there were divergences in the Summaries of Product Characteristics (SPC) including quality aspects of Singulair and associated names approved across EU Member States, with respect to the following indications: Treatment of asthma as add-on therapy in patients with mild to moderate persistent asthma who are inadequately controlled on inhaled corticosteroids and in whom “as-needed” short acting β-agonists provide inadequate clinical control of asthma; as an alternative treatment option to low-dose inhaled corticosteroids for patients with mild persistent asthma who do not have a recent history of serious asthma attacks that required oral corticosteroid use, and who have demonstrated that they are not capable of using inhaled corticosteroids; prophylaxis of asthma in paediatric patients in which the predominant component is exercise-induced bronchoconstriction.
Slovenian: Podlaga za napotitev so bila razhajanja med povzetki glavnih značilnosti zdravila, vključno z vidiki kakovosti zdravila Singulair in z njim povezanih imen, ki so odobreni v državah članicah EU, in sicer v zvezi z naslednjimi indikacijami: dodatna terapija za zdravljenje astme pri bolnikih z blago do zmerno perzistentno astmo, pri katerih bolezni ne moremo zadostno uravnati z inhalacijskimi kortikosteroidi in pri katerih β-agonisti s kratkotrajnim delovanjem, uporabljeni „po potrebi“, ne nudijo zadostnega kliničnega nadzora nad astmo; alternativna terapija, s katero se nadomešča zdravljenje z nizkim odmerkom inhalacijskih kortikosteroidov pri bolnikih z blago perzistentno astmo, ki nedavno niso imeli hudih napadov astme, pri katerih bi bila potrebna uporaba peroralnih kortikosteroidov, in pri katerih je bilo ugotovljeno, da ne morejo uporabljati inhalacijskih kortikosteroidov; preprečevanje astme pri pediatričnih bolnikih, pri katerih prevladuje bronhokonstrikcija, ki jo sproži napor.
English: The list of product names concerned is given in Annex I. The scientific conclusions are provided in Annex II together with the amended SPC, Labelling and Package Leaflet in Annex III.
Slovenian: Seznam zadevnih imen proizvodov je naveden v Dodatku I. Znanstveni zaključki so podani v Dodatku II, spremenjeni povzetki glavnih značilnosti zdravila, označevanje in navodila za uporabo pa v Dodatku III.
English: On 13 September 2007, Merck Sharp & Dohme presented to the EMEA a referral under Article 30 of Directive 2001/83/EC, as amended, in order to harmonise the nationally authorised Summaries of Product Characteristics (SPC), Labelling and Package Leaflet including quality aspects of the medicinal product Singulair and associated names.
Slovenian: Družba Merck Sharp & Dohme je dne 13. septembra 2007 agenciji EMEA predložila napotitev v skladu s členom 30 Direktive 2001/83/ES, kakor je bila spremenjena, da bi uskladila na nacionalni ravni odobrene povzetke glavnih značilnosti zdravila (SPC), označevanje in navodila za uporabo, kot tudi vidike kakovosti zdravila Singulair in z njim povezanih imen.
English: Singulair and associated names, 4mg, chewable tablets and oral granules, is a leukotriene-1 receptor antagonist used for the add-on treatment (concomitantly with inhaled steroids), as alternative monotherapy to low-dose inhaled corticosteroids, and to prevent exercise-induced bronchoconstriction.
Slovenian: Zdravilo Singulair in z njim povezana, 4mg, žvečljive tablete in peroralna zrnca, je antagonist receptorjev za levkotrien-1, ki se uporablja kot dodatno zdravljenje (sočasno z inhalacijskimi steroidi), kot alternativna monoterapija, s katero se lahko nadomesti zdravljenje z nizkim odmerkom inhalacijskih kortikosteroidov, in za preprečevanje bronhokonstrikcije, ki jo sproži napor.
English: During its 21 - 24 April 2008 meeting, the CHMP, in the light of the overall submitted data and the scientific discussion within the Committee, was of the opinion that the proposal for the harmonisation of the SPC, Labelling and Package leaflet including the quality aspects was acceptable and that they should be amended.
Slovenian: CHMP je na svojem zasedanju, ki je potekalo od 21. do 24. aprila 2008, na podlagi vseh predloženih podatkov in znanstvene razprave znotraj Odbora sprejel mnenje, da je predlog za uskladitev povzetkov glavnih značilnosti zdravila, označevanja in navodil za uporabo, vključno z vidiki kakovosti, sprejemljiv in da je omenjeno dokumentacijo treba dopolniti.
English: The CHMP gave a positive opinion on 24 April 2008 recommending the harmonisation of the SPC, Labelling and Package Leaflet including quality aspects for Singulair and associated names.
Slovenian: CHMP je dne 24. aprila 2008 sprejel pozitivno mnenje, s katerim priporoča uskladitev povzetkov glavnih značilnosti zdravila, označevanja in navodil za uporabo, vključno z vidiki kakovosti, za zdravilo Singulair in z njim povezana imena.
English: COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) OPINION FOLLOWING AN ARTICLE 30 REFERRAL FOR Singulair and associated names International Non-Proprietary Name (INN): montelukast
Slovenian: ODBOR ZA ZDRAVILA ZA UPORABO V HUMANI MEDICINI (CHMP) MNENJE V ZVEZI Z NAPOTITVIJO V SKLADU S ČLENOM 30 ZA Singulair in z njim povezana imena
English: Member State EU/EEA
Slovenian: Država članica/EEA
English: Therefore, this scenario was not considered for sheep.
Slovenian: Zato ta scenarij ni bil upoštevan za ovce.
English: Postępu 17 B 02-676 Warszawa POLAND
Slovenian: Postępu 17 B 02-676 Warszawa POLJSKA
English: 1123 Budapest HUNGARY
Slovenian: 1123 Budapest MADŽARSKA
English: 2909 LD Capelle a/d IJssel THE NETHERLANDS
Slovenian: 2909 LD Capelle a/d IJssel NIZOZEMSKA
English: The information in some of these products is considered insufficient to mitigate the risk to the environment.
Slovenian: Informacije v nekaterih od teh zdravil naj bi bile nezadostne za zmanjšanje tveganja za okolje.
English: 00330 Helsinki FINLAND
Slovenian: 00330 Helsinki FINSKA
English: 811 09 Bratislava SLOVAK REPUBLIC
Slovenian: 811 09 Bratislava SLOVAŠKA REPUBLIKA
English: Applicant/marketing authorisation holder
Slovenian: Predlagatelj/ Imetnik dovoljenja za promet
English: Kennedy L-1855 Luxembourg LUXEMBOURG
Slovenian: Kennedy L-1855 Luxembourg LUKSEMBURG
English: Via Isonzo, 71 04100 Latina ITALY
Slovenian: Via Isonzo, 71 04100 Latina ITALIJA
English: This period was also considered sufficiently conservative for use in reindeer.
Slovenian: To obdobje naj bi bilo dovolj konzervativno tudi za uporabo pri jelenjadi.
English: This is a likely source of the variation in the observed residue levels.
Slovenian: To je verjeten vir variacije v opaženih vrednostih ostankov.
English: SPECIAL WARNING(S), IF NECESSARY
Slovenian: POSEBNA OPOZORILA, ČE SO POTREBNA
English: Add, to all products:
Slovenian: Dodati za vsa zdravila:
English: Doramectin is an antiparasitic agent.
Slovenian: Doramektin je antiparazitik.
English: Add, to all products: 4.5 Special precaution for use
Slovenian: Dodati za vsa zdravila: 4.5Posebni previdnostni ukrepi
English: 109 37401 Amboise Cedex, FRANCE
Slovenian: 109 37401 Amboise Cedex, FRANCIJA
English: Labelling:
Slovenian: Označevanje:
English: 35396 Gießen GERMANY
Slovenian: 35396 Gießen NEMČIJA
English: As a result these studies did not include quality control measures and the accuracy of the injection site sampling is therefore questionable.
Slovenian: Posledično te študije niso vključevale ukrepov za nadzor kakovosti, zato je točnost vzorčenja na mestu injiciranja vprašljiva.
English: The figure of 66 days was rounded up to 70 days, to bring it into line with the figure recommended for cattle.
Slovenian: 66 dni je bilo zaokroženih navzgor na 70 dni, da ustreza priporočeni vrednosti za govedo.
English: Both compounds share a wide spectrum of antiparasitic activity and produce a similar paralysis in nematodes and parasitic arthropods.
Slovenian: Obe spojini imata širok spekter antiparazitskega delovanja in tvorita podobno paralizo pri nematodih in pri parazitskih artropodih.
English: For cattle it was considered that the standard 2 month period between treatment and calving could be accepted.
Slovenian: Za govedo so ocenili, da bi bilo sprejemljivo standardno 2-mesečno obdobje med zdravljenjem in otelitvijo.
English: 13 Rue Pages 92158 Suresnes Cedex FRANCE
Slovenian: 13 Rue Pages 92158 Suresnes Cedex FRANCIJA
English: Consumer safety
Slovenian: Varnost za potrošnika
English: The marketing authorisation holders provided a Phase II environmental risk assessment.
Slovenian: Imetniki dovoljenj za promet z zdravili so predložili oceno tveganja za okolje faze II.
English: List of the names, pharmaceutical forms, strengths of the veterinary medicinal products, animal species, routes of administration, applicants/marketing authorisation holders in the Member States
Slovenian: Seznam imen, farmacevtskih oblik, jakosti zdravila, živalskih vrst, poti uporabe, predlagateljev/imetnikov dovoljenja za promet v državah članicah.
English: Two studies in sheep were provided.
Slovenian: Predloženi sta bili dve študiji pri ovcah.
English: Amend where applicable:
Slovenian: Dopolniti, kjer je primerno:
English: By applying this ratio to milk and using 6 µg as the total amount of doramectin residues that can be considered safe in 1.5 litres of milk (i.e. the amount of milk considered to be consumed on a daily basis), one can calculate the concentration of doramectin in milk that can be considered safe to be 3.44 µg/l (6 µg x 0.86/1.5 l).
Slovenian: Z uporabo tega razmerja za mleko in z uporabo količine 6 µg kot celotne količine ostankov doramektina, ki se jih lahko varno zaužije v 1,5 litra mleka (tj. količina mleka, ki naj bi jo zaužili vsakodnevno), se lahko izračuna koncentracija doramektina v mleku, ki se lahko oceni kot varna in znaša 3,44 µg/l (6 µg x 0,86/1,5 l).
English: Residue data
Slovenian: Podatki o ostankih
English: The value of 3.44 µg/l was rounded down to 3 µg/l, which was considered to represent a safe doramectin level in milk.
Slovenian: Vrednost 3,44 µg/l je bila zaokrožena navzdol na 3 µg/l, kar naj bi predstavljalo varno raven doramektina v mleku.
English: The current data package does not allow the assessment of bioaccumulation and therefore, bioaccumulation of doramectin cannot be ruled out.
Slovenian: Trenutni nabor podatkov ne omogoča izvedbe ocene biološkega kopičenja, zato biološkega kopičenja doramektina ni mogoče izključiti.
English: PFIZER HELLAS AE 243 Av Mesogeion 15451, Athens GREECE
Slovenian: PFIZER HELLAS AE 243 Av Mesogeion 15451, Athens GRČIJA
English: As some data in reindeer were available it was considered appropriate to refine this estimate.
Slovenian: Ker so določeni podatki pri jelenjadi bili na voljo, so ocenili, da je primerno prilagoditi ta približek.
English: While no data were available that would allow the establishment of the ratio of marker to total residues for milk, it was considered that the ratio established by CVMP for fat (0.86) could be applied to milk.
Slovenian: Čeprav ni bilo na voljo podatkov, ki bi omogočali določitev razmerja med označevalcem in celokupnimi ostanki za mleko, je bilo ocenjeno, da se lahko razmerje, ki ga je CVMP določil za maščobo (0,86), uporabi tudi za mleko.
English: It is a macrocyclic lactone closely related to ivermectin.
Slovenian: Je makrociklični lakton, ki je soroden ivermektinu.
English: Several studies in cattle were provided.
Slovenian: Predloženih je bilo več študij pri govedu.
English: Meat and offal: 77 days
Slovenian: Meso in organi: 77 dni.
English: Following treatment, excretion of potentially toxic levels of doramectin may take place over a period of several weeks.
Slovenian: Po zdravljenju lahko izločanje potencialno toksičnih ravni doramektina traja še več tednov.
English: In respect to the environmental impact for the use of the solution for injection in sheep the CVMP considered that according to the CVMP guidance, only cattle are concerned with the scenario “direct excretion into surface water”.
Slovenian: V zvezi z vplivom na okolje pri uporabi raztopine za injiciranje pri ovcah je CVMP menil, da v skladu z navodili CVMP „scenarij neposrednega izločanja v površinske vode‟ velja samo za govedo.
English: The supplementary data provided did not allow ruling out a medium to long-term risk to dung insects.
Slovenian: Na podlagi predloženih dodatnih podatkov ni bilo mogoče izključiti srednje- do dolgoročnega tveganja za insekte, prisotne v gnoju.
English: However, in view of the fact that the study was not performed in line with standards in place today, it was considered that the withdrawal period of 70 days recommended in the 2005 referral procedure under Article 34 of Directive 2001/82/EC for Dectomax 1% injectable solution for cattle and sheep (EMEA/V/A/009) should be maintained.
Slovenian: Ker študija ni bila izvedena v skladu z današnjimi standardi, pa je bilo ocenjeno, da bi bilo treba ohraniti karenco 70 dni, kot je priporočeno v napotitvenem postopku iz leta 2005 v skladu s členom 34 Direktive 2001/82/ES za zdravilo Dectomax 1 % raztopina za injiciranje za govedo in ovce (EMEA/V/A/009).