natgillin/translations-raw huggingface dataset:
MARKETING AUTHORISATION NUMBER(S) EU/2/19/239/001
ŠTEVILKA(E) DOVOLJENJ(A) ZA PROMET EU/2/19/239/001
Pull out the needle and release the skin.
Izvlecite iglo in spustite kožo.
The active substances in Baycox Iron are allowed substances as described in table 1 of the annex to Commission Regulation (EU) No 37/2010:
Učinkovine v Baycox Iron so dovoljene učinkovine, kot so navedene v tabeli 1(dovoljene snovi) priloge Uredbe Komisije (EU) št. 37/2010:
To ensure the correct dosage, the piglets' body weight should be determined as accurately as possible.
Za zagotovitev pravilnega odmerjanja je treba telesno maso pujskov določiti čim natančneje.
Iron is not readily eliminated; most of it is re-used, while only small amounts are eliminated.
Železose običajno ne izloča; večina se ga ponovno uporabi, ob tem se izločijo le majhne količine.
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 20/05/2019
DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Datum pridobitve dovoljenja za promet: 20/05/2019
There is no specific organ for iron excretion.
Za izločanje železa ni posebnega organa.
The responsible veterinarian should take into account the results of clinical examinations and/or analysis of faecal samples and/or histological findings, which confirmed the presence of C. suis in a previous infection episode on the farm.
Odgovorni veterinar mora upoštevati rezultate kliničnih preiskav in / ali analiz vzorcev blata in / ali histoloških ugotovitev, ki so potrdile prisotnost C. suis v predhodnem primeru okužbe na kmetiji.
From 72 h onwards, this is followed by a very slowly decreasing plasma concentration with a calculated mean half-life of 960 h, indicating equilibrium conditions.
Od 72. ur dalje sledi počasno zniževanje plazemske koncentracije z izračunanim razpolovnim časom 960 ur, kar kaže na stanje ravnovesja.
In intensive farming conditions, piglets do not have access to other sources of iron, such as soil.
V intenzivnih proizvodnih sistemih pujski nimajo dostopa do drugih virov železa, kot so tla.
Cardboard box with 1 vial.
Kartonska škatla z 1 vialo.
Meat and offal: 53 days.
Meso in organi: 53 dni.
For porcine species the fat MRL relates to ‘skin and fat in natural proportions'.
Za prašiče se MRL za maščobo nanaša na kožo in maščobo v naravnih razmerjih“.
Wash hands after use and/or spillage.
Po uporabi in / ali razlitju si umijte roke.
Piglet deaths have been reported which have been attributed to an increased susceptibility to infection due to temporary blocking of the reticuloendothelial system.
Poročano je bilo o poginih pujskov, ki so bili pripisani povečani dovzetnosti za okužbe zaradi začasne blokade retikuloendotelijskega sistema.
Therefore, piglets should be supplemented with iron.
Zato je treba pujskom železo dodajati.
(as gleptoferron
(kot gleptoferon
Anaphylactic reactions may occur rarely.
Redko se lahko pojavijo anafilaktične reakcije.
Accidental self-injection may cause adverse effects.
Nenamerno samo-injciranje lahko povzroči neželene učinke.
The primary routes of iron excretion are via faeces and urine, there are additional small losses in sweat, hair and nails.
Glavne poti izločanja železa so blato in urin, dodatne manjše izgube preko znoja, las in nohtov.
Introduce the needle at an angle of 90° and inject the product.
Iglo vstavite pod kotom 90 ° in zdravilo injicirajte.
It is therefore recommended to concomitantly improve the hygiene conditions in the farm concerned, particularly by increasing dryness and cleanliness.
Zato je priporočljivo sočasno izboljšanje higienskih pogojev na kmetiji, s poudarkom na suhem in čistem okolju.
Iron (as gleptoferron)
Železo (kot gleptoferon)
It is a constituent of haemoglobin and myoglobin and has a key role in enzymes, such as cytochromes, catalases, and peroxidases.
Je sestavina hemoglobina in mioglobina ter ima ključno vlogo pri encimih, kot so citokromi, katalaze in peroksidaze.
The product is not recommended for use in piglets weighing less than 0.9 kg.
Uporaba zdravila ni priporočljiva za pujske, ki tehtajo manj kot 0,9 kg.
Pregnant women and women intending to conceive should avoid contact with the veterinary medicinal product, especially accidental self-injection.
Nosečnice in ženske, ki nameravajo zanositi, naj se izogibajo stiku z zdravilom, še posebej nenamernemu samo-injiciranju.
5 mg For the full list of excipients, see section 6.1.
Za celoten seznam pomožnih snovi, glejte poglavje 6.1.
Therefore, the product should be administered to all animals before the expected onset of clinical signs, that is, in the prepatent period.
Zato je treba živali zdravilo dati pred pričakovanim pojavom kliničnih znakov, torej v latentnem obdobju.
PHARMACEUTICAL FORM Suspension for injection
FARMACEVTSKA OBLIKA suspenzija za injiciranje
Piglets are born with only moderate stores of iron and the milk consumed by piglets is a poor source of iron.
Pujski se skotijo le z zmernimi zalogami železa, mleko, ki ga uživajo pujski, pa je slab vir železa.
Once clinical signs of coccidiosis are evident, damage to the small intestine will have already occurred.
Ko so opazni klinični znaki kokcidioze, so se že pojavile poškodbe tankega črevesa.
The doser on the device should be adjusted according to the piglets' weight prior to injection.
Odmernik naprave mora biti prilagojen glede na maso pujska pred injiciranjem.
In some cases (n=13 out of n=29 animals treated multiple times with 3 times the recommended dose) this resulted in death of the animals.
V nekaterih primerih (n = 13 od n = 29 živali, zdravljenih večkrat s 3-kratnim priporočenim terapevtskim odmerkom), je to povzročilo pogin živali, kar je verjetno posledica preobremenitve telesa z železom.
It has coccidiocidal activity against all intracellular development stages of the genus Cystoisospora, that is, merogony (asexual multiplication) and gamogony (sexual phase).
Ima kokcidiocidno aktivnost proti vsem intracelularnim razvojnim stadijem rodu Cystoisospora, to je merogonijo (nespolno razmnoževanje) in gamogonijo (spolna faza).
These deaths have been associated with genetic factors or deficiencies of vitamin E and/or selenium.
Ti pogini so povezani z genskimi dejavniki ali pomanjkanjem vitamina E in/ali selena.
All mammalian food producing species
Vse vrste sesalcev za proizvodnjo hrane
Total plasma exposure reaches 3868 to 4097 mg*h/l.
Skupna plazemska izpostavljenost znaša 3868 do 4097 mg*h/l.
It is not recommended to use the veterinary medicinal product in piglets weighing less than 0.9 kg, as the efficacy and safety of the product has not been evaluated in such small piglets.
Uporaba pri pujskih, ki tehtajo manj kot 0,9 kg ni priporočljiva, saj učinkovitost in varnost zdravila pri njih nista bili ovrednoteni.
Special precautions for use in animals: The product must not be administered more than once.
Posebni previdnostni ukrepi za uporabo pri živalih: Zdravila se ne sme dati več kot enkrat.
In case of overdose, supportive measures such as chelating agents (e.g. deferoxamine) can be used.
V primeru prevelikega odmerjanja je mogoče uporabiti podporne ukrepe, kot je dajanje kelatnih sredstev (npr. deferoksamina).
People with known hypersensitivity to iron (as gleptoferron complex) should avoid contact with the veterinary medicinal product.
Osebe z znano preobčutljivostjo na železo (kot kompleks gleptoferona) naj se izogibajo stiku z zdravilom za uporabo v veterinarski medicini.
In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician.
V primeru nenamernega samo-injiciranja poiščite takoj zdravniško pomoč in zdravniku pokažite navodilo za uporabo ali ovojnino.
Total plasma exposure reaches between 1046 and 1245 mg*h/l.
Skupna plazemska izpostavljenost znaša med 1046 in 1245 mg* h/l.
Not for use in animals from which eggs are produced for human consumption.
Ni za uporabo pri živalih, katerih jajca se uporabljajo za prehrano ljudi.
In the blood, free iron (III)-ions bind to transferrin (transport form) and are mainly used for the synthesis of haemoglobin.
V krvi se prosti železovi III-ioni vežejo na transferin (transportna oblika) in se večinoma uporabljajo za sintezo hemoglobina.
Toltrazuril reaches peak plasma concentrations of 4.17 to 6.43 mg/l within 5 days.
Toltrazuril doseže največjo koncentracijo v plazmi 4,17 do 6,43mg/l v 5 dneh.
Do not use in cases of hypersensitivity to the active substances or to any of the excipients.
Ne uporabite v primeru preobčutljivosti na učinkovine ali katero koli pomožno snov.
Toltrazuril and its metabolites are mainly eliminated in faeces via biliary excretion and to a small extent via urine.
Toltrazuril in njegovi metaboliti se v glavnem izločajo z blatom z izločanjem žolča in v manjšem obsegu preko urina.
Should clinical signs be observed in the two weeks following administration of the product, contact your veterinarian to obtain an appropriate differential diagnosis.
Če opazite klinične znake v dveh tednih po zdravljenju z zdravilom, se posvetujte z veterinarjem, da dobite ustrezno diferencialno diagnozo.
Transferrin-iron saturation levels may lead to increased susceptibility for (systemic) bacterial infection, pain, inflammatory reactions as well as abscess formation at the injection site.
Stopnje nasičenja s transferinom in železom lahko privedejo do povečane dovzetnosti za (sistemsko) bakterijsko okužbo, bolečine, vnetne reakcije in nastajanje abscesov na mestu injiciranja.
Plasma iron concentration peaks within the first day reaching concentrations of 548 mg/l at 6 hours after injection.
Največje koncentracije železa v plazmi v prvem dnevu dosežejo koncentracije 548 mg/l 6 ur po injiciranju.
When administering the product to larger groups of animals, a multi-dosing device (with vented drawoff apparatus) is recommended.
Pri zdravljenju večjih skupin živali je priporočena večodmerna naprava (z odvodnim izvlečnim aparatom).
Pack size: Cardboard box with 1 vial of 100 ml.
Pakiranje: Kartonska škatla z eno vialo z 100 ml.
Toltrazuril-sulfone is eliminated from plasma with a half-life of about 5 to 7 days.
Toltrazuril-sulfon se izloča iz plazme z razpolovno dobo približno 5 do 7 dni.
The draw-off needle should be removed after administration.
Odvzemno iglo je treba po dajanju odstraniti.
Toltrazuril is eliminated from plasma with a halflife of about 3 to 4 days showing substantial metabolism to toltrazuril-sulfoxide and toltrazurilsulfone, the main active metabolite.
Toltrazuril se izloča iz plazme z razpolovno dobo 3 do 4 dni, kar kaže znatno presnovo do toltrazuril-sulfoksida in glavnega aktivnega metabolita toltrazuril-sulfona.
Shake well before use until a visually homogenous suspension is obtained and no residual product is adhering to (the bottom of) the glass vial.
Pred uporabo dobro pretresite, dokler ne dobite vizualno homogene suspenzije in na dnu steklene viale ne vidite preostanka zdravila.
After intramuscular injection, the iron complex is absorbed mainly into the lymphatic tissue, where it is split to release iron (III)-ions.
Po intramuskularni injekciji se kompleks železa absorbira predvsem v limfno tkivo, kjer se razcepi, da sprosti železov III-ion.
Excipients: Phenol
Pomožna snov: fenol
Only use this veterinary medicinal product where Cystoisospora suis has been historically confirmed on a farm.
To veterinarsko zdravilo uporabljajte le, kjer je Cystoisospora suis potrjen na kmetiji.
For the concurrent prevention of clinical signs of coccidiosis (such as diarrhoea) in neonatal piglets on farms with a confirmed history of coccidiosis caused by Cystoisospora suis, and prevention of iron deficiency anaemia.
Za sočasno preprečevanje kliničnih znakov kokcidioze (kot je diareja) pri novo skotenih pujskih na kmetijah s predhodno potrjeno obolevnostjo za kokcidiozo, ki jo povzroča Cystoisospora suis, in hkratno preprečevanje anemije zaradi pomanjkanja železa pri pujskih.
Not applicable.
prav tako ni potreben.
Colourless silicone-coated glass Type II vials with chlorobutyl stoppers and aluminium caps containing 100 ml.
Viala iz brezbarvnega stekla tipa II s silikonsko prevleko s klorobutilnim zamaškom in aluminijastimo zaporko, ki vsebuje 100 ml.
Free iron (III)-ions are removed from plasma with a half-life of approximately 8 hours.
Prosti železovi III-ioni se odstranijo iz plazme z razpolovno dobo približno 8 ur.
The tolerance of the veterinary medicinal product has been assessed after a single intramuscular administration of up to 5 times the recommended dose, as well as after repeated administrations.
Toleranca zdravila je bila ocenjena po enkratnem intramuskularnem dajanju do 5-kratnega priporočenega odmerka in po ponavljajočih se odmerkih.
After the 2nd or 3rd administration of 3 times the recommended dose, clinical signs were observed such as apathy, dyspnoea, elevated rectal temperatures, reddening of the skin, ataxia, and/or adverse events of the legs or joints (such as polyarthritis).
Po drugi ali tretji uporabi trikratnega priporočenega terapevtskega odmerka so bili opaženi klinični znaki kot je apatija, dispneja, zvišana rektalna temperatura, pordelost kože in/ali ataksijo in /ali neželeni učinki na nogah ali sklepih (kot je poliartritis).
Toltrazuril-sulfone shows plasma peak concentrations of 6.23 to 8.08 mg/l at 11 to 15 days after injection of the parent drug.
Toltrazurilsulfon kaže koncentracije v plazmi največ 6,23 do 8,08 mg/l 11 do 15 dni po injiciranju zdravila.
Should clinical signs be observed in the two weeks following administration of the product, the responsible veterinarian should be informed.
Če opazite klinične znake v dveh tednih po zdravljenju z zdravilom, obvestite odgovornega veterinarja.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Bayer Animal Health GmbH
IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM Bayer Animal Health GmbH
Persistent discolouration of muscle tissue at the injection site may occur.
Lahko se pojavi obstojno razbarvanje mišičnega tkiva na mestu injiciranja.
Care should be taken to avoid accidental selfinjection.
Bodite previdni, da se izognete nenamernemu samo-injiciranju.
When administering the product to a group of animals, use a draw-off needle that has been placed in the vial stopper to avoid excess broaching of the stopper.
Pri zdravljenju skupine živali z zdravilom je priporočena uporaba odvzemne igle, ki je vstavljena v zamašek viale, da se tako izognete prekomernemu prebadanju zamaška.
Do not use in piglets suspected to be suffering from a deficiency of vitamin E and/or selenium.
KONTRAINDIKACIJE Ne uporabite pri pujskih, pri katerih obstaja sum, da imajo pomanjkanje vitamina E in/ali selena.
Name and address of the manufacturer(s) responsible for batch release
Ime in naslov proizvajalca(proizvajalcev) zdravila, odgovornega (odgovornih) za sproščanje serij
After a single intramuscular injection of the recommended dose rate of 20 mg toltrazuril per kg body weight to piglets, toltrazuril plasma pharmacokinetics are characterised by biological variability.
Po enkratnem intramuskularnem injiciranju pri terapevtskem odmerku 20 mg toltrazurila na kg telesne mase pujska je za farmakokinetiko v plazmi značilna biološka variabilnost.
Bayer s.r.o., Animal Health Siemensova 2717/4 CZ-155 00 Praha 5
Slovenská republika Bayer s.r.o., Animal Health Siemensova 2717/4 CZ-155 00 Praha 5
EXPIRY DATE EXP {month/year} Once broached, use within 28 days.
EXP {mesec/leto} Po odprtju uporabite v 28 dneh.
After an overdose, iatrogenic poisoning may occur which may cause the following clinical signs: pale mucous membranes, haemorrhagic gastroenteritis, vomiting, tachycardia, hypotension, dyspnoea, oedema of the limbs, lameness, shock, liver damage, and death.
V primeru prevelikega odmerjanja se pojavi iatrogena zastrupitev, ki se pojavi v obliki sledečih kliničnih znakov: bleda sluznica, hemoragični gastroenteritis, bruhanje, tahikardija, hipotenzija, dispneja, edem okončin, šepanje, šok, poškodba jeter, pogin.
Toltrazuril is a triazinon derivative and an antiprotozoal agent.
Toltrazuril je derivat triazinona in učinkovina za zdravljenje protozojskih bolezni.
Pull the skin to the side before inserting the needle.
Pred vbadanjem igle potegnite kožo na stran.
Pharmacologically active substances
Farmakološko aktivna snov
Bayer Limited The Atrium Blackthorn Road IE-Dublin 18
Blackthorn Road IE-Dublin 18
Pharmacotherapeutic groups: Toltrazuril, combinations ATCvet code: QP51AJ51
Oznaka ATC vet: QP51AJ51
Shake the vial well before use.
Pred uporabo vialo dobro pretresite.
METHOD AND ROUTE(S) OF ADMINISTRATION Intramuscular use.
NAČIN IN POT(I) UPORABE
A single intramuscular administration of 5 times the recommended dose, or 3 administrations of the recommended dose, did not cause systemic adverse effects or abnormalities in local injection site observations.
Enkratno intramuskularno dajanje 5-kratnega terapevtskega odmerka ali 3 odmerkov terapevtskega odmerka ni povzročilo sistemskih neželenih učinkov ali sprememb na mestu injiciranja, ki bi odstopale od normalnega stanja.
STATEMENT OF ACTIVE SUBSTANCES 1 ml contains 36 mg toltrazuril and 182 mg iron (III) (as gleptoferron)
1 ml vsebuje 36 mg toltrazurila in 182 mg železa (III) (kot gleptoferon).
5 mg Slightly viscous dark brown suspension.
5 mg rahlo viskozna temno rjava suspenzija INDIKACIJA(E)
The iron (III)-ions are stored as ferritin in the main storage organs (e.g. liver, spleen and the reticuloendothelial system), and iron elimination does not play a quantitatively important role.
Železovi III-ioni so shranjeni kot feritin v glavnih organih za shranjevanje (npr. jetra, vranica in retikuloendotelni sistem)
Neonatal piglets may experience clinical signs similar to those due to coccidiosis (such as diarrhoea) for numerous reasons (e.g. other pathogens, stress).
Novo skoteni pujski lahko iz številnih razlogov ( kot so drugi patogeni, stres) izražajo klinične znake, podobne tistim, ki so posledica kokcidioze (kot je driska).
The veterinary medicinal product should be administered to piglets between 48 to 72 hours after birth with a single intramuscular injection of 20 mg toltrazuril/kg body weight and 100 mg iron (as gleptoferron complex)/kg body weight, which is a dose volume of 0.55 ml/kg body weight.
Veterinarski produkt je potrebno dati pujskom od 48 do 72 ur po skotitvi z enim intramuskularnim injiciranjem 20 mg toltrazurila/kg telesne mase in 100 mg železa (kot kompleks gleptoferona)/kg telesne mase.
The excipients listed in section 6.1 of the SPC are either allowed substances for which table 1 of the annex to Commission Regulation (EU) No 37/2010 indicates that no MRLs are required or are considered as not falling within the scope of Regulation (EC) No 470/2009 when used as in this veterinary medicinal product.
Uredbe Komisije (EU) št. 37/2010 določa, da MRL ni potreben ali pa ne spadajo v področje uporabe
The preferred injection site is the neck area (see illustration below).
Vsakemu pujsku je treba zdravilo injicirati z iglo premera 21 G. Najboljše mesto injiciranja je območje vratu (glej sliko spodaj).
Transient discolouration of the tissue and/or slight swelling may be observed commonly at the site of injection.
Pogosto je na mestu injiciranja mogoče opaziti prehodno razbarvanje tkiva in/ali rahlo otekanje.
Shelf life after first opening the immediate packaging: 28 days.
Rok uporabnosti po prvem odpiranju stične ovojnine: 28 dni.
TARGET SPECIES Pigs (piglets 48 to 72 hours after birth)
CILJNE ŽIVALSKE VRSTE prašiči (pujski 48 do 72 ur po skotitvi)
It is recommended to administer the product to all the piglets in a litter.
Priporočljivo je, da se zdravi vse pujske v leglu.
Deaths have been reported rarely in piglets following the administration of parenteral iron injections.
O poginih pujskov po dajanju parenteralnih injekcij železa je bilo poročano redko.
Do not use this veterinary medicinal product after the expiry date which is stated on the carton and label after “EXP”.
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, navedenega na škatli in viali za oznako EXP.Rok uporabnosti zdravila se nanaša na zadnji dan v navedenem mesecu.
Pregnancy and lactation: Not applicable.
Uporaba v obdobju brejosti, laktacije ali nesnosti: Ni smiselno.
MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
PROIZVAJALEC ZDRAVILA ODGOVOREN ZA SPROŠČANJE SERIJ
Special precautions for use in animals The product must not be administered more than once.
4.5 Posebni previdnostni ukrepi Posebni previdnostni ukrepi za uporabo pri živalih Zdravila se ne sme dati več kot enkrat.
Slightly viscous dark brown suspension.
FARMACEVTSKA OBLIKA suspenzija za injiciranje rahlo viskozna temno rjava suspenzija
36.4 mg
36,4 mg železo (III)
TARGET SPECIES Pigs (piglets 48 to 72 hours after birth).
4.1 Ciljne živalske vrste prašiči (pujski 48 do 72 ur po skotitvi).
The “No MRL required” classification for iron dextran and iron glucoheptonate is considered to apply to gleptoferron as gleptoferron is expected to release iron dextran and iron glucoheptonate.
Za razvrščanje železovega dekstrana in železovega glukoheptonata ni potreben MRL,
MRLs (µg/kg)
(MRL)
Marketing authorisation holder: Bayer Animal Health GmbH 51368 Leverkusen Germany
Imetnik dovoljenja za promet z zdravilom: Bayer Animal Health GmbH 51368 Leverkusen Nemčija
NAME OF THE VETERINARY MEDICINAL PRODUCT Baycox Iron 36 mg/ml + 182 mg/ml suspension for injection for piglets
IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI Baycox Iron 36 mg/ml + 182 mg/ml suspenzija za injiciranje za pujske
NAME OF THE VETERINARY MEDICINAL PRODUCT Baycox Iron 36 mg/ml +182 mg/ml suspension for injection for piglets toltrazuril / iron (III) (as gleptoferron)
IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI Baycox Iron 36 mg/ml + 182 mg/ml suspenzija za injiciranje za pujske toltrazuril / železo III (kot gleptoferon)
This product contains iron (as gleptoferron complex), which has been associated with anaphylactic reactions after injection.
Posebni previdnostni ukrepi, ki jih mora izvajati oseba, ki živalim daje zdravilo To zdravilo vsebuje železo (kot kompleks gleptoferona), ki je bilo po injiciranju povezano z anafilaktičnimi reakcijami.
Muscle Skin and fat
Maščobno tkivo Jetra Ledvica
PARTICULARS TO APPEAR ON THE OUTER PACKAGE Outer carton
PODATKI NA ZUNANJI OVOJNINI ŠKATLA
4.7 Use during pregnancy, lactation or lay
Uporaba v obdobju brejosti, laktacije ali nesnosti Ni smiselno.
MARKETING AUTHORISATION HOLDER Bayer Animal Health GmbH D-51368 Leverkusen
Bayer Animal Health GmbH D-51368 Leverkusen
Ask your veterinary surgeon or pharmacist how to dispose of medicines no longer required.
ZDRAVILA ALI ODPADNIH SNOVI, ČE OBSTAJAJO Glede odstranjevanja zdravil, ki jih ne uporabljate več, se posvetujte z veterinarjem ali farmacevtom.
This product may be harmful for the unborn child.
To zdravilo lahko škodljivo vpliva na plod.
Poultry
Perutnina 100
Liver Kidney
OVOJNINAH VIALA
Sodium chloride Water for injections
Seznam pomožnih snovi fenol polisorbat 80 polisorbat 20 natrijev klorid voda za injekcije
Special precautions to be taken by the person administering the veterinary medicinal product to animals
IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI
WITHDRAWAL PERIOD(S) Withdrawal period:
DATUM ZADNJE ODOBRITVE NAVODIL ZA UPORABO
A new logo has been adopted.
Sprejet je bil nov logotip.
• Supplement to Agenda point 12b.
• Dodatek k točki dnevnega reda 12b.
More information has been provided in the written report.
Več informacij je na voljo v pisnem poročilu.
The proposed amendments were presented at the October meeting and no comments were received.
Predlagane spremembe so bile predstavljene na oktobrski seji, nanje pa ni bilo nobenih pripomb.
The first day will be dedicated to discussion on decision-making.
Prvi dan bo namenjen razpravi o odločanju.
However, members decided to reject the proposal.
Vendar so člani odbora zavrnili predlog.
The main goal for the Agency is to ensure safety of vaccines.
Glavni cilj agencije je zagotavljati varnost cepiv.
The Board welcomed the work programme.
Upravni odbor je pozdravil delovni program.
However, this is only a fraction of the total number of generic products coming to the EU markets.
Vendar je to le delček skupnega števila generičnih proizvodov, ki prihajajo na trge EU.
New visual identity
Nova vizualna podoba